NATIONAL
INTEGRATED
ACCREDITATION FOR
HEALTHCARE
ORGANIZATIONS
(NIAHO
®
)
Accreditation Requirements,
Interpretive Guidelines and Surveyor Guidance ‐ Revision 18
DNV GL Healthcare
400 Techne Center Drive, Suite 100
Milford, OH 45150
Phone 513‐947‐8343 • Fax 513‐947‐1250
© Copyright 2005‐2018 DNV GL Healthcare USA, Inc.
All Rights Reserved. No
claim to U.S. Government work.
SAFER, SMARTER, GREENER
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TABLE OF CONTENTS
GLOSSARY .......................................................................................................................... viii
QUALITY MANAGEMENT SYSTEM (QM) ..................................................................................... 10
QM.1 QUALITY MANAGEMENT SYSTEM ..................................................................................... 10
QM.2 ISO 9001 QUALITY MANAGEMENT SYSTEM ...................................................................... 10
QM.3 QUALITY OUTLINE/PLAN................................................................................................ 11
QM.4 MANAGEMENT REPRESENTATIVE .................................................................................... 12
QM.5 DOCUMENTATION AND MANAGEMENT REVIEWS ............................................................... 12
QM.6 SYSTEM REQUIREMENTS ............................................................................................... 12
QM.7 MEASUREMENT, MONITORING, ANALYSIS ........................................................................ 13
QM.8 PATIENT SAFETY SYSTEM .............................................................................................. 14
GOVERNING BODY (GB) ........................................................................................................ 16
GB.1 LEGAL RESPONSIBILITY ................................................................................................ 16
GB.2 INSTITUTIONAL PLAN AND BUDGET ................................................................................ 16
GB.3 CONTRACTED SERVICES ................................................................................................ 17
CHIEF EXECUTIVE OFFICER (CE) ............................................................................................ 19
CE.1 QUALIFICATIONS .......................................................................................................... 19
CE.2 RESPONSIBILITIES ....................................................................................................... 19
MEDICAL STAFF (MS) ............................................................................................................ 20
MS.1 ORGANIZED MEDICAL STAFF ......................................................................................... 20
MS.2 ELIGIBILITY ................................................................................................................. 20
MS.3 ACCOUNTABILITY ......................................................................................................... 20
MS.4 RESPONSIBILITY .......................................................................................................... 21
MS.5 EXECUTIVE COMMITTEE ................................................................................................ 23
MS.6 MEDICAL STAFF PARTICIPATION ..................................................................................... 23
MS.7 MEDICAL STAFF BYLAWS ............................................................................................... 24
MS.8 APPOINTMENT ............................................................................................................. 25
MS.9 PERFORMANCE DATA .................................................................................................... 25
MS.10 CONTINUING EDUCATION ............................................................................................ 26
MS.11 GOVERNING BODY ROLE .............................................................................................. 26
MS.12 CLINICAL PRIVILEGES ................................................................................................. 27
MS.13 TEMPORARY CLINICAL PRIVILEGES ............................................................................... 28
MS.14 CORRECTIVE OR REHABILITATION ACTION .................................................................... 29
MS.15 ADMISSION REQUIREMENTS ........................................................................................ 30
MS.16 MEDICAL RECORD MAINTENANCE ................................................................................. 31
MS.17 HISTORY AND PHYSICAL .............................................................................................. 31
MS.18 CONSULTATION .......................................................................................................... 33
MS.19 AUTOPSY ................................................................................................................... 34
MS.20 TELEMEDICINE ........................................................................................................... 34
NURSING SERVICES (NS) ...................................................................................................... 36
NS.1 NURSING SERVICE ....................................................................................................... 36
NS.2 NURSE EXECUTIVE ....................................................................................................... 38
NS.3 ASSESSMENT AND PLAN OF CARE ................................................................................... 39
STAFFING MANAGEMENT (SM) ............................................................................................... 42
SM.1 LICENSURE OR CERTIFICATION ...................................................................................... 42
SM.2 PROFESSIONAL SCOPE .................................................................................................. 42
SM.3 DEPARTMENT SCOPE OF SERVICE ................................................................................... 42
SM.4 DETERMINING AND MODIFYING STAFFING ...................................................................... 43
SM.5 JOB DESCRIPTION ........................................................................................................ 43
SM.6 ORIENTATION .............................................................................................................. 43
SM.7 STAFF EVALUATIONS .................................................................................................... 44
MEDICATION MANAGEMENT (MM)........................................................................................... 47
MM.1 MANAGEMENT PRACTICES ............................................................................................. 47
MM.2 FORMULARY ................................................................................................................ 57
MM.3 SCHEDULED DRUGS ..................................................................................................... 58
MM.4 MEDICATION ORDERS .................................................................................................. 59
MM.5 REVIEW OF MEDICATION ORDERS .................................................................................. 60
MM.6 OVERSIGHT GROUP ...................................................................................................... 63
MM.7 AVAILABLE INFORMATION ............................................................................................. 64
SURGICAL SERVICES (SS) ..................................................................................................... 65
SS.1 ORGANIZATION ............................................................................................................ 65
SS.2 STAFFING AND SUPERVISION ......................................................................................... 67
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SS.3 PRACTITIONER PRIVILEGES ........................................................................................... 68
SS.4 HISTORY AND PHYSICAL ................................................................................................ 69
SS.5 AVAILABLE EQUIPMENT ................................................................................................. 71
SS.6 OPERATING ROOM REGISTER ......................................................................................... 72
SS.7 POST-OPERATIVE CARE ................................................................................................. 73
SS.8 OPERATIVE REPORT ...................................................................................................... 74
ANESTHESIA SERVICES (AS) ................................................................................................. 77
AS.1 ORGANIZATION ............................................................................................................ 77
AS.2 ADMINISTRATION ......................................................................................................... 80
AS.3 POLICIES AND PROCEDURES .......................................................................................... 83
LABORATORY SERVICES (LS) ................................................................................................. 87
LS.1 ORGANIZATION ............................................................................................................ 87
LS.2 POTENTIALLY INFECTIOUS BLOOD AND PRODUCTS ........................................................... 87
LS.3 PATIENT NOTIFICATION ................................................................................................. 90
LS.4 GENERAL BLOOD SAFETY ............................................................................................... 92
RESPIRATORY CARE SERVICES (RC) ....................................................................................... 94
RC.1 ORGANIZATION ............................................................................................................ 94
RC.2 ORDERS FOR TREATMENT AND INTERVENTIONS ............................................................... 94
RC.3 POLICIES OR PROTOCOLS .............................................................................................. 95
RC.4 TESTS OUTSIDE THE LABORATORY ................................................................................. 95
MEDICAL IMAGING (MI) ........................................................................................................ 97
MI.1 ORGANIZATION ............................................................................................................ 97
MI.2 RADIATION PROTECTION ............................................................................................... 97
MI.3 EQUIPMENT .................................................................................................................. 98
MI.4 ORDER ........................................................................................................................ 99
MI.5 SUPERVISION ............................................................................................................... 99
MI.6 STAFF ........................................................................................................................ 100
MI.7 RECORDS ................................................................................................................... 100
MI.8 INTERPRETATION AND RECORDS .................................................................................. 100
NUCLEAR MEDICINE SERVICES (NM) .................................................................................... 102
NM.1 ORGANIZATION ......................................................................................................... 102
NM.2 RADIOACTIVE MATERIALS ........................................................................................... 102
NM.3 EQUIPMENT AND SUPPLIES ......................................................................................... 103
NM.4 INTERPRETATION ....................................................................................................... 104
REHABILITATION SERVICES (RS) ......................................................................................... 105
RS.1 ORGANIZATION .......................................................................................................... 105
RS.2 MANAGEMENT AND SUPPORT ....................................................................................... 105
RS.3 TREATMENT PLAN/ORDERS .......................................................................................... 106
EMERGENCY DEPARTMENT (ED) ........................................................................................... 107
ED.1 ORGANIZATION .......................................................................................................... 107
ED.2 STAFFING .................................................................................................................. 107
ED.3 EMERGENCY SERVICES NOT PROVIDED ......................................................................... 108
ED.4 OFF-CAMPUS DEPARTMENTS ........................................................................................ 109
OUTPATIENT SERVICES (OS) ............................................................................................... 110
OS.1 ORGANIZATION .......................................................................................................... 110
OS.2 STAFFING .................................................................................................................. 110
OS.3 SCOPE OF SERVICE .................................................................................................... 110
OS.4 ORDERS .................................................................................................................... 111
DIETARY SERVICES (DS) ..................................................................................................... 113
DS.1 ORGANIZATION .......................................................................................................... 113
DS.2 SERVICES AND DIETS ................................................................................................. 114
DS.3 DIET MANUAL ............................................................................................................ 115
PATIENT RIGHTS (PR) ......................................................................................................... 117
PR.1 NONDISCRIMINATION ................................................................................................. 117
PR.2 SPECIFIC RIGHTS ....................................................................................................... 117
PR.3 ADVANCE DIRECTIVE .................................................................................................. 121
PR.4 LANGUAGE AND COMMUNICATION ................................................................................ 123
PR.5 INFORMED CONSENT ................................................................................................... 123
PR.6 GRIEVANCE PROCEDURE .............................................................................................. 124
PR.7 RESTRAINT OR SECLUSION .......................................................................................... 126
PR.8 RESTRAINT OR SECLUSION: STAFF TRAINING REQUIREMENTS....................................... 138
PR.9 RESTRAINT OR SECLUSION: REPORT OF DEATH .............................................................. 140
INFECTION PREVENTION AND CONTROL (IC) ......................................................................... 143
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IC.1 INFECTION PREVENTION and CONTROL SYSTEM .............................................................. 143
MEDICAL RECORDS SERVICE (MR) ....................................................................................... 149
MR.1 ORGANIZATION ......................................................................................................... 149
MR.2 COMPLETE MEDICAL RECORD ....................................................................................... 149
MR.3 RETENTION ............................................................................................................... 150
MR.4 CONFIDENTIALITY ...................................................................................................... 150
MR.5 RECORD CONTENT ..................................................................................................... 151
MR.6 IDENTIFICATION OF AUTHORS ..................................................................................... 153
MR.7 REQUIRED DOCUMENTATION ....................................................................................... 154
DISCHARGE PLANNING (DC) ................................................................................................ 157
DC.1 WRITTEN POLICIES ..................................................................................................... 157
DC.2 DISCHARGE PLANNING EVALUATION ............................................................................. 158
DC.3 PLAN IMPLEMENTATION ............................................................................................... 159
DC.4 EVALUATION .............................................................................................................. 160
UTILIZATION REVIEW (UR) .................................................................................................. 162
UR.1 DOCUMENTED PLAN .................................................................................................... 162
UR.2 SAMPLING ................................................................................................................. 163
UR.3 MEDICAL NECESSITY DETERMINATION .......................................................................... 163
UR.4 EXTENDED STAY REVIEW ............................................................................................. 164
PHYSICAL ENVIRONMENT (PE) ............................................................................................. 165
PE.1 FACILITY .................................................................................................................... 165
PE.2 LIFE SAFETY MANAGEMENT SYSTEM .............................................................................. 175
PE.3 SAFETY MANAGEMENT SYSTEM ..................................................................................... 178
PE.4 SECURITY MANAGEMENT SYSTEM .................................................................................. 179
PE.5 HAZARDOUS MATERIAL (HAZMAT) MANAGEMENT SYSTEM ................................................ 181
PE.6 EMERGENCY MANAGEMENT SYSTEM .............................................................................. 182
PE.7 MEDICAL EQUIPMENT MANAGEMENT SYSTEM .................................................................. 186
PE.8 UTILITY MANAGEMENT SYSTEM ..................................................................................... 193
ORGAN, TISSUE AND EYE PROCUREMENT (TO) ....................................................................... 197
TO.1 PROCESS ................................................................................................................... 197
TO.2 ORGAN PROCUREMENT ORGANIZATION (OPO) WRITTEN AGREEMENT ................................ 197
TO.3 ALTERNATIVE AGREEMENT ........................................................................................... 199
TO.4 RESPECT FOR PATIENT RIGHTS .................................................................................... 199
TO.5 DOCUMENTATION ....................................................................................................... 200
TO.6 ORGAN TRANSPLANTATION .......................................................................................... 200
TO.7 TRANSPLANT CANDIDATES .......................................................................................... 200
SWING BEDS (SB) .............................................................................................................. 202
SB.1 FACILTY ELIGIBILITY ................................................................................................... 202
ADMISSION, TRANSFER AND DISCHARGE (TD) ...................................................................... 203
TD.1 TRANSFER AND DISCHARGE REQUIREMENTS.................................................................. 203
TD.2 DOCUMENTATION ....................................................................................................... 204
TD.3 NOTIFICATION ........................................................................................................... 204
TD.4 ORIENTATION FOR TRANSFER OR DISCHARGE ................................................................ 205
TD.5 CHANGE OF ROOM IN COMPOSITE DISTINCT PART .......................................................... 206
TD.6 DISCHARGE SUMMARY ................................................................................................ 206
PLAN OF CARE (PC) ............................................................................................................ 207
PC.1 ASSESSMENT ............................................................................................................. 207
PC.2 CARE PLAN ................................................................................................................. 208
RESIDENTS RIGHTS (RR) .................................................................................................... 210
RR.1 EXERCISE OF RIGHTS ................................................................................................. 210
RR.2 NOTICE OF RIGHTS AND SERVICES ............................................................................... 210
RR.3 HEALTH CARE DECISIONS ............................................................................................ 212
RR.4 ADVANCE DIRECTIVES ................................................................................................. 212
RR.5 MEDICAID BENEFITS ................................................................................................... 213
RR.6 PERSONAL PRIVACY AND CONFIDENTIALITY ................................................................... 213
RR.7 RESTRAINTS .............................................................................................................. 215
RR.8 FREEDOM FROM ABUSE, NEGLECT, AND EXPLOITATION ................................................... 215
RR.9 WORK ....................................................................................................................... 218
FACILITY SERVICES (FS) ..................................................................................................... 220
FS.1 PATIENT ACTIVITIES ................................................................................................... 220
FS.2 SOCIAL SERVICES ....................................................................................................... 221
FS.3 DENTAL SERVICES ...................................................................................................... 222
FS.4 SPECIALIZED REHABILITATIVE SERVICES ...................................................................... 223
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RESIDENT NUTRITION (RN) ................................................................................................. 227
RN.1 NUTRITIONAL STATUS ................................................................................................. 227
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Use of NIAHO
®
Accreditation Requirements, Interpretive Guidelines and Surveyor Guidance
Effective Date
NIAHO
®
Accreditation Requirements, Interpretive Guidelines and Surveyor Guidance, Revision 18
Effective Date: March 5, 2018.
Supersedes NIAHO
®
Revision 16 and all prior revisions. (Revision numbers now align with year of publication)
National Professional Organizations- Standards of Practice
Standards of practice of the national professional organizations referenced in these NIAHO
®
Accreditation
Requirements, Interpretive Guidelines and Surveyor Guidance (NIAHO
®
) document are consultative and considered in
the accreditation decision.
Federal Laws, Rules and Regulations
The most current version of Federal law and the CFR referenced in this NIAHO
®
document are incorporated herein by
reference and constitute NIAHO
®
accreditation requirements.
This NIAHO
®
document is based upon the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation
42 CFR Section 482 and State Operations Manual Regulations and Interpretive Guidelines for Hospitals. These
Interpretive Guidelines also are periodically updated based on notices distributed from CMS. Hospitals participating in
the Medicare and Medicaid program are expected to comply with current Conditions of Participation (CoP). When new
or revised requirements are published, hospitals are expected to demonstrate compliance in a time frame consistent
with the effective date published by CMS in the Federal Register.
Life Safety Code
®
The Life Safety Code
®
of the National Fire Protection Association referenced in this NIAHO
®
document is incorporated
herein by reference and constitute NIAHO
®
accreditation requirements.
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®
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GLOSSARY
AANA American Association of Nurse Anesthetists
ACS American College of Surgeons
ACIP CDC’s Advisory Committee on Immunization Practices
AOA American Osteopathic Association
AMA American Medical Association
AORN Association of perioperative Registered Nurses
APIC Association of Professionals in Infection Control and Epidemiology
APP Advanced Practice Provider
ASA American Society of Anesthesiologists
ASHP American Society of Health-System Pharmacists
CDC Centers for Disease Control and Prevention
CEO Chief Executive Officer
CFR Code of Federal Regulations
CMS Centers for Medicare and Medicaid Services
CoP CMS Conditions of Participation for Hospitals 42 C.F.R Section 482
CRNA Certified Registered Nurse Anesthetist
DEA Drug Enforcement Administration Federal Narcotics Registration Certificate
DOT United States Department of Transportation
FDA Food and Drug Administration
HAI Healthcare Associated Infection
HHA Home Health Agency
HICPAC CDC’s Healthcare Infection Control Practices Advisory Committee
HVAC Heating Ventilating and Air Conditioning
ISMP Institute for Safe Medication Practices
ISO International Organization of Standardization
LPN Licensed Practical Nurse
LVN Licensed Vocational Nurse
LSC Life Safety Code
®
of the National Fire Protection Association
MHAUS Malignant Hyperthermia Association of the United States
NFPA National Fire Protection Association
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NIAHO National Integrated Accreditation for Healthcare Organizations
NPDB National Practitioner Data Bank
OIG Office of Inspector General, Department of Health and Human Services
OSHA Occupational Health and Safety Administration
PRN (prn) Pro re nata, as the occasion arises, when necessary
QIO Quality Improvement Organization
QMS Quality Management System
QLP Qualified Licensed Practitioner
RN Registered Nurse
Secretary Secretary of the Department of Health and Human Services
SGNA Society of Gastroenterology Nurses and Associates
SHEA Society for Healthcare Epidemiology of America
SMDA Safe Medical Devices Act of 1990
SNF Skilled Nursing Facility
SOP Standard Operating Procedure
SR Standard Requirement (accreditation requirement)
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QUALITY MANAGEMENT SYSTEM (QM)
QM.1 QUALITY MANAGEMENT SYSTEM
The governing body (or organized group or individual who assumes full legal authority and responsibility for
operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring
that the organization implements and maintains an effective quality management system. This quality management
system shall ensure that corrective and preventive actions taken by the organization are implemented, measured
and monitored.
In addition to any other Quality Management System standard, the organization is required to comply with QM.1 at
all times as a part of its Quality Management System. Until the organization achieves ISO 9001 Compliance/
Certification, the organization shall follow at a minimum the ISO 9001 methodology specified in QM.2, SR.3.
SR.1 The organization must develop, implement, and maintain an ongoing system for managing quality
and patient safety.
SR.1a As a part of the QMS for addressing performance improvement and patient safety, the
organization must select projects or similar activities that focus attention on various
processes, functions and areas of the organization.
SR.1a (1) The number and scope of these projects or similar activities will be conducted
annually and be proportional to the scope and complexity of the organization’s
operations and services offered.
SR.1a (2) These projects or similar activities will be documented to include the rationale for
selection and measurable progress achieved.
SR.1a (3) If the organization participates in a Quality Improvement Organization (QIO)
cooperative project, the organization must demonstrate that information and
supporting documentation is provided to the QIO. If the hospital does not
participate in a QIO, the projects and activities are required to be of comparable
effort.
SR.2 The organization must implement hospital-wide quality assessment and performance improvement
efforts to address priorities for improved quality of care and patient safety and that corrective and
preventive actions are implemented and evaluated for effectiveness.
SR.3 The organization will assure that adequate resources are allocated for measuring, assessing,
improving, and sustaining the hospital's performance and reducing risk to patients.
QM.2 ISO 9001 QUALITY MANAGEMENT SYSTEM
SR.1 Compliance with the ISO 9001 standard must occur within three (3) years after the initial deemed
NIAHO
®
accreditation. The Organization shall either demonstrate compliance with the ISO 9001
Quality Management System principles through a NIAHO
®
accreditation survey or maintain
Certification through an Accredited Registrar. Only certificates covered by an accreditation under an
IAF MLA (International Accreditation Forum Multilateral Recognition Agreement) signatory shall be
eligible. The organization shall maintain ISO 9001 compliance or formal Certification in order to
remain eligible for NIAHO
®
Accreditation.
SR.2 An Accredited Registrar recognized by an IAF MLA (International Accreditation Forum Multilateral
Recognition Agreement) shall meet the following minimum criteria:
SR.2a Shall be accredited for IAF Scope 38; and,
SR.2b Must have certified or conducted a pre-assessment at a minimum of 12 hospitals.
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SR.3 The organization will initiate and continue implementation of the ISO 9001 methodology to achieve
compliance or certification as stated in QM.1 SR.1. At a minimum, the organization must be able to
demonstrate at the time of the NIAHO
®
Accreditation survey, evidence of the following:
SR.3a Control of Documents: the organization’s documents (i.e. policies, procedures, forms) are
structured in a manner to ensure that only the proper revisions are available for use;
SR.3b Control of Records: the organization ensures that suitable records are maintained for the
CoP and NIAHO® requirements;
SR.3c Internal Surveys (Internal Audits): the organization conducts internal reviews of its
processes and resultant corrective/preventive action measures have been implemented and
verified to be effective;
SR.3d Corrective and Preventive Action: the organization will have a mechanism in place to
document and monitor corrective and preventive action implemented in some manner to
address improvement and changes, where appropriate;
SR.3e The organization has established measurable quality objectives, the results are analyzed,
addressed, and;
SR.3f Appropriate information has been submitted to the oversight group for quality management
as required in QM.6 SR.1 as well as senior management for review and analysis during a
management review process.
Interpretive Guidelines:
The ISO 9001 requirements are assessed during each survey of the organization. The organization has 3 years from
the initial deemed NIAHO
®
accreditation to achieve compliance or certification to ISO 9001. If the organization is
currently certified to ISO 9001, the Registrar that currently certifies the organization must be verified using current
criteria established under SR.2a and SR.2b. This should be verified prior to the organization’s accreditation survey.
The organization shall demonstrate that aspects consistent with ISO 9001 methodologies identified in QM.2,
SR.3aSR.3f are present. These aspects may not be at a level of compliance with ISO 9001, but will be in place in
some manner. If the survey team is conducting the annual ISO periodic survey during the NIAHO
®
survey, the
survey team will assess the applicable ISO 9001 requirements and review the status of findings and corrective
action(s) taken to validate that they have been implemented. A separate ISO 9001 report will be created to indicate
any findings as a result of the ISO survey, when applicable.
Surveyor Guidance:
The lead surveyor will be provided information regarding the organization with regard to their current compliance or
certification status to ISO 9001 prior to the accreditation survey.
The lead surveyor will describe the process to the senior leadership for being in compliance with or attaining
certification to ISO 9001, if the organization is not already ISO certified.
If the organization is already certified to ISO 9001 and the survey team is not conducting the periodic annual survey
required by ISO at the time of the NIAHO
®
survey, the lead surveyor will verify that the Registrar is an Accredited
Registrar in accordance with QM.2, SR.2.
The survey team will verify that the organization has implemented mechanisms to demonstrate that similar practices
in place, consistent with ISO methodologies as listed in QM.2, SR.3a – SR.3f, are present in some manner and
continued through the period the hospital is required to maintain compliance or certification to ISO 9001 at which
time the full scope of the ISO 9001 requirements must be met as stated within the timeframe under QM.2, SR.1.
QM.3 QUALITY OUTLINE/PLAN
SR.1 The organization shall clearly outline its methodology, practice and related policies for addressing
how quality and performance are measured, monitored, analyzed, and continually improving health
outcomes and reducing risks for patients.
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Interpretive Guidelines:
The organization will present documentation to the survey team that clearly defines how quality and performance are
measured, monitored, analyzed, and continually improved.
Surveyor Guidance:
The organization can document conformance in a variety of ways. An example would include a Quality Manual or
Performance Improvement / Quality Management Plan. Verify that the organization has clearly defined how they
measure quality and performance. The monitoring methods, data analysis, and effectiveness of action(s) taken will
be verified.
QM.4 MANAGEMENT REPRESENTATIVE
A management representative shall be designated and shall have the responsibility and authority for ensuring that
the requirements of the Quality Management System are implemented and maintained.
Interpretive Guidelines:
Senior leadership is required to designate an individual as a Management Representative. The Management
Representative is responsible for ensuring that the QMS is effectively implemented and maintained and that the quality
oversight processes ensure that corrective and preventive action(s) are carried out and are measured for effectiveness.
It is expected that the Management Representative will report to senior leadership on the status of the QMS.
Surveyor Guidance:
Verify documentation to demonstrate that the Management Representative has been identified and that there is a
defined scope of responsibilities for this individual.
QM.5 DOCUMENTATION AND MANAGEMENT REVIEWS
Any variations, deficiencies or non-conformities identified by the organization shall be addressed. Appropriate
corrective or preventive action will be determined, applied, and documented. Documentation of activities may take
the form of a Failure, Mode and Effect Analysis, Root Cause Analysis, Performance Report, Non-Conformity Report,
specific Improvement Project analysis, etc. This documentation shall become a part of the Management Review
performed at regular intervals, at a minimum of once annually.
Interpretive Guidelines:
The organization is to have identified, applied and documented nonconformity (non-compliance) throughout the
organization and the subsequent corrective/preventive action(s) taken. The organization can demonstrate this in
various ways, but there should be information present that validates that the organization has corrected the
nonconformity and that the action(s) implemented have been effective and sustained. The organization should be
able to demonstrate that planned actions were effective by quantifiable measurement subject to internal reviews
(internal audits) or other means,
The results of these activities are communicated to senior leadership, usually conducted as a part of the Quality
Management Oversight process. Quality Management Oversight is defined as the formal evaluation by the
interdisciplinary group described in QM.6, SR.1 of the status, adequacy and effectiveness of the QMS. The Quality
Management Oversight process may or may not be the same process as formal ISO 9001 Management Review.
Surveyor Guidance:
Review examples of the following: Nonconformity Report, Root Cause Analysis, Failure Mode and Effects Analysis, or
other documents that the organization can demonstrate a means of recording non-conformity and the subsequent
follow-up to determine that the action(s) taken have been effective. If there are different means for reporting
nonconformity, the surveyor will determine the consistency of the process to ensure its effectiveness.
QM.6 SYSTEM REQUIREMENTS
In establishing the QMS, the organization shall be required to have the following as a part of this system:
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SR.1 Interdisciplinary group to oversee the Quality Management System with representation from/for
Administration, Nursing, Pharmacy Services, Ancillary Services, Information Management, Risk /
Safety Management, Quality Facilitator/Management Representative, and Medical staff members
who must be doctors of medicine or osteopathy. This interdisciplinary group shall conduct
Management Reviews regarding the effectiveness of the Quality Management System;
SR.2 The organization shall define and document the QMS in place, to include clinical and non-clinical
services;
SR.3 Statement of the Quality Policy;
SR.4 Measurable Quality Objectives; and,
SR.5 Goal Measurement / Prioritization of activities to include:
SR.5a Focus on high-risk, problem-prone areas, processes or functions;
SR.5b Consideration of the incidence, prevalence and severity of problems in these areas,
processes or functions;
SR.5c Health outcomes, patient safety, and quality of care.
Interpretive Guidelines:
The Management Representative supports and facilitates the QMS; however, it is the responsibility of senior
leadership to review these activities and see that appropriate actions are taken for continual improvement. The
Quality Manual or other similar document outlines the process that the organization has in place. The Quality Manual
will include or reference the policies and procedures for the QMS, Quality Policy, and Quality Objectives. The
organization must carry out Management Reviews which encompass review of corrective/preventive actions taken,
results from internal reviews (internal audits), customer (patient) satisfaction, data analysis and other performance
improvement activities.
The Management Review Process is to be carried out by senior leadership throughout the organization.
The Quality Management Oversight Process may or may not be the same process as formal ISO 9001 Management
Review.
Surveyor Guidance:
Verify that Quality Management Oversight reviews have taken place and there are appropriate minutes recorded.
The QMS will be documented in a Quality Manual, Performance Improvement Plan or similar document as identified
by the organization. A part of the QMS will include or reference the Quality Policy, Quality Objectives, and how
processes and services are monitored and measured.
QM.7 MEASUREMENT, MONITORING, ANALYSIS
The organization shall evaluate organized services and processes, both direct and supportive, including services
provided by contracted services. The interdisciplinary group referred to in QM.6, SR.1, also known as the Quality
Management Oversight group, shall conduct these evaluations. The monitoring shall include the use of internal
reviews (audits) of key processes as defined by the organization at scheduled intervals, not to exceed one year, and
data related to these processes. Measurement, monitoring and analysis of processes throughout the organization
requires established measures that have the ability to detect variation, identify problem processes, identify both
positive and negative outcomes, and effectiveness of actions taken to improve performance and/or reduce risks. The
governing body of the organization must define the frequency and detail of the measurement. Those functions to be
measured, at a minimum, must include the following:
SR.1 Threats to patient safety (i.e. falls, pt. identification, injuries);
SR.2 Medication therapy/medication use; to include medication reconciliation, high risk drugs, look alike-
sound alike medications, and the use of dangerous abbreviations;
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SR.3 Operative and invasive procedures; to include wrong site/wrong patient/wrong procedure surgery;
SR.4 Anesthesia/moderate sedation adverse events;
SR.5 Blood and blood components-adverse events/usage;
SR.6 Restraint use/seclusion;
SR.7 Effectiveness of pain management system;
SR.8 Infection prevention and control system, including hospital acquired infections (HAI);
SR.9 Utilization Management System;
SR.10 Patient flow issues, to include reporting of patients held in the Emergency Department or the PACU
for extended periods of time (as defined by the organization);
SR.11 Customer satisfaction, both clinical and support areas;
SR.12 Discrepant pathology reports;
SR.13 Unanticipated deaths
SR.14 Adverse events/ Near misses;
SR.15 Readmissions and unplanned returns to surgery (as defined); SR.16 Critical and/or pertinent
processes, both clinical and supportive; SR.17 Medical record delinquency; and,
SR.18 Physical Environment Management Systems
Interpretive Guidelines:
In order for the organization to continually improve its QMS, the services and processes must be measured to
determine their effectiveness. Through an internal review mechanism, the organization will determine where
corrective/preventive action(s) are to be taken and have a process in place to determine the effectiveness of
action(s) taken.
As a part of this measurement component, the functions listed above must be measured for the organization to
determine the effectiveness of these processes for continual improvement and preserving the safety of the patients
and staff.
The organization should have collected and analyzed data in the respective functions listed above to demonstrate
that these processes are closely monitored.
All departments and services provided are to be included as a part of the quality management oversight for the
organization. This will include, but is not limited to: Inpatient services, anesthesia services, surgical services,
contract services, outpatient services, rehabilitation services, and other support services.
An Adverse Event shall be defined as an unexpected occurrence or variation that led to death or serious physical or
psychological harm. This definition includes the National Quality Forum (NQF) “never or adverse events” that are
errors in medical care that are clearly identifiable, preventable and serious in their consequences for patients.
Surveyor Guidance:
The organization can demonstrate the effectiveness of its QMS through the analysis of data and follow up where
variation exists in order to implement corrective/preventive action. Evaluate the internal review process and
subsequent effectiveness of action(s) taken to improve performance. The organization will be assessed according to
its ability to effectively monitor and measure those areas listed above.
Look for data analysis and measures in place to determine the effectiveness of these processes.
QM.8 PATIENT SAFETY SYSTEM
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SR.1 The organization shall have a means for establishing clear expectations for identifying and detecting
the
prevalence and severity of incidents that impact or threaten patient safety. This shall include
medical errors and adverse patient events.
SR.2 The organization’s Patient Safety System shall be documented and shall address the following:
SR.2a Detection;
SR.2b Preventative and corrective action;
SR.2c Defined processes to reduce risk;
SR.2d Implementation of action plans;
SR.2e On-going measurement to ensure action effectiveness;
SR.2f Management review of response and resource allocation utilizing the results of patient
adverse events and other data analysis; and,
SR.2g Policy and procedure of informing patients and/or their families about unexpected adverse
events.
Interpretive Guidelines:
In certain circumstances, there are incidents that impact or threaten patient safety. It is the responsibility of the
organization to develop means of controlling processes to ensure the processes are safe for patients and staff as
they are carried out.
The organization should identify, implement and regularly assess the means by which these incidents are prevented
or when they occur. The incidents are studied to detect nonconformance and where risk points or failures are an
inherent part of the process and work to remove these risk points or failures from the system.
Surveyor Guidance:
The organization’s creation of an environment that is safe for patients and staff is imperative. Assess the ability of
the organization to detect and prevent adverse patient events, act accordingly to improve these processes through
corrective/preventive action and monitoring the effectiveness of their efforts. This could be done by reviewing root
cause analyses and/or failure modes and effects analysis where such processes or events have been studied and the
associated documentation to support findings, corrective/preventive action(s) taken and the follow-up to determine
their effectiveness.
When such incidents occur, a process must be in place to address customer (patient) communication, how the
patients are informed and their right to know the circumstances of events. Such communication does not imply
wrong
doing on the part of the organization or its staff members. The process identifies the most effective way of
responding to such events. The process also requires a level of communication for the customer (patient) to know
that the organization is acting responsibly and will promote the safest environment possible.
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GOVERNING BODY (GB)
GB.1 LEGAL RESPONSIBILITY
There must be an effective governing body that is legally responsible for the conduct of the organization. The
governing body is responsible for all services provided in the organization including all contracted services. If an
organization does not have an organized governing body, the persons legally responsible for the conduct of the
organization must carry out the functions specified that pertain to the governing body.
SR.1 The governing body (or organized group or individual who assumes full legal authority and
responsibility for operations of the hospital), medical staff, and administrative officials (to include
the chief executive officer, chief financial officer, and nurse executive) are responsible and
accountable for ensuring that the following:
SR.1a The organization is in compliance with all applicable Federal and State laws and in
accordance with organization policies and procedures regarding the health and safety of its
patients;
SR.1b The organization is licensed by the appropriate State or local authority responsible for
licensing hospitals;
SR.1c Criteria that includes aspects of individual character, competence, training, experience and
judgment is established for the selection of individuals working for the organization, directly
or under contract, and/or appointed through the formal medical staff appointment process;
and,
SR.1d The personnel working in the organization are properly licensed or otherwise meet all
applicable Federal, State and local laws.
Interpretive Guidelines:
There should only be one governing body responsible for the day-to-day operation of the organization. If more than
one governing body is identified (ex. a healthcare system with local and system governing bodies), the reporting
structure and responsibility of the respective bodies should be identified and differentiated. In the absence of an
organized governing body, the organization must provide written documentation that identifies the individual or
individuals that are responsible for the conduct of hospital operations.
Surveyor Guidance:
Verify that the hospital has an organized governing body and/or has written documentation that identifies the
individual or individuals that are responsible for the conduct of the hospital operations.
Interview the hospital leadership to determine the reporting structure regarding how information flows to and from
the governing body.
The reporting structure may include written reports, presentations by staff at board meetings, or other means.
GB.2 INSTITUTIONAL PLAN AND BUDGET
SR.1 The organization shall have an overall plan that includes an annual operating budget that contains all
anticipated income and expenses and is prepared according to generally accepted accounting
principles.
SR.2 The plan must provide for capital expenditures for at least a 3-year period including the year
identified in GB.2, SR.1. The plan must include and identify in detail the objective of, and the
anticipated sources of financing for each anticipated capital expenditure in excess of $600,000 (or
lesser amount established by the State in which the organization is located in accordance with
Section 1122(g)(1) of the Social Security Act and is related to:
SR.2a. Acquisition of land;
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SR.2b Improvement of land, buildings and equipment, or
SR.2c. Replacement, modernization or expansion of buildings or equipment.
SR.3 The plan must be reviewed and updated annually.
SR.4 The plan must be prepared under the direction of the governing body and by a committee
consisting of representatives of the governing body, the administrative staff, and the medical staff
of the institution.
SR.5 If required, the plan must be submitted for review in accordance with Section 1122 of the Social
Security Act or, as applicable, to the appropriate health planning agency in the State.
Surveyor Guidance:
Verify that an institutional plan and budget exists, includes descriptions of items and complies with all standard
requirements. It is not within the scope of activities or responsibility of the surveyor to review and assess the
amounts or structure of the institutional plan and budget.
Assess the process for developing the budget and the parties involved. Verify that the institutional plan and budget
are updated at least annually and that the process is done under the direction of the governing body and members
of the administrative staff and medical staff.
GB.3 CONTRACTED SERVICES
SR.1 The governing body shall require annual management reviews of selected indicators to ensure that
contracted services (including joint ventures or shared services) provide services that are safe and
effective and that comply with all applicable NIAHO
®
requirements.
SR.2 The governing body is responsible for services furnished in the hospital whether or not they are
furnished under contract. The organization must evaluate and select contracted services (including
joint ventures or shared services) (and non-contracted services) entities/individuals based on their
ability to supply products and/or services in accordance with the organization’s requirements.
Criteria for selection, evaluation, and re-evaluation shall be established. The criteria for selection
will include the requirement that the contracted entity or individual to provide the products/services
in a safe and effective manner and comply with all applicable NIAHO
®
standards, and standards
required for all contracted services.
SR.3 A documented list of contracted companies and individuals, including their scope/nature of services
shall be maintained.
SR.4 When telemedicine services are furnished to the hospital’s patients through an agreement with a
distant-site telemedicine entity, the written agreement specifies that the distant-site telemedicine
entity is a contractor of services to the hospital and as such, in accordance with GB.2, SR.2,
furnishes the contracted services in a manner that permits the hospital to comply with all applicable
requirements for the contracted services, including, but not limited to, the requirements in Medical
Staff (MS.2, MS.3 , MS.7, MS.11) and Governing Body (GB.1) with regard to the distant-site
telemedicine entity’s physicians and practitioners providing telemedicine services. The governing
body of the hospital whose patients are receiving the telemedicine services may, in accordance with
MS.20, SR.1, grant privileges to physicians and practitioners employed by the distant-site
telemedicine entity based on such hospital’s medical staff recommendations; such staff
recommendations may rely on information provided by the distant-site telemedicine entity.
SR.5 When telemedicine services are furnished to the hospital’s patients through an agreement with a
distant-site hospital, the agreement is written and that it specifies that it is the responsibility of the
governing body of the distant-site hospital to meet the requirements in Medical Staff (MS.2, MS.3,
MS.7, MS.11) and Governing Body (GB.1) with regard to the distant-site hospital’s physicians and
practitioners providing telemedicine services. The governing body of the hospital whose patients are
receiving the telemedicine services may, in accordance with MS.20, SR.2, grant privileges based on
its medical staff recommendations that rely on information provided by the distant-site hospital.
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SR.5a The distant-site hospital providing the telemedicine services is a Medicare participating
hospital.
SR.5b The individual distant-site physician or practitioner is privileged at the distant-site hospital
providing the telemedicine services, which provides a current list of the distant-site
physician’s or practitioner’s privileges.
SR.5c The individual distant-site physician or practitioner holds a license issued or recognized by
the State in which the hospital, whose patients are receiving the telemedicine services, is
located.
Interpretive Guidelines:
The governing body is responsible for assuring that hospital services are provided in compliance with NIAHO
®
standards and according to acceptable standards of practice regardless of whether the services are provided directly
by hospital employees or by a contracted entity.
When services are provided by a contracted entity, the governing body must identify the criteria for selection and
procurement of services, and the means of evaluating the contracted entity. Evaluation timeframes/intervals shall be
established.
The organization will prioritize the review of contracted services to ensure that patient care services or those services
that would also be carried out by staff employed by the organization to ensure these are comparable. Other
contracts will be assessed in accordance with the organization’s policy as defined. It is not the expectation that such
contracts as that for cable television or plumbing, for example, would be assessed in the same manner as those
related to patient care services. However, if services provided under contract will have an impact in some manner
for patient care services, the organization will review these services and monitor the appropriate measures to ensure
the expectations of the organization and needs of the patient are being met.
There may be arrangements where services are provided through one or more of the following: joint ventures;
informal agreements; shared services; or, lease arrangements. These services are also subject to the criteria for
selection and evaluation process.
Surveyor Guidance:
Determine the services that are carried out by a contracted entity and the scope of their responsibilities. In a
sampling of these contracts, review a contract to see that it addresses the criteria for selection and the evaluation
processes identified in the organization’s policies and procedures. Verify that the organization has a mechanism in
place to review the contract and performance of each entity no less than once annually.
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CHIEF EXECUTIVE OFFICER (CE)
CE.1 QUALIFICATIONS
SR.1 The governing body must appoint a chief executive officer who is qualified through education and
experience to be responsible for managing the organization.
CE.2 RESPONSIBILITIES
SR.1 The chief executive officer is responsible for operating the organization, according to the authority
conferred by the governing body. The chief executive officer shall provide for the organization’s
compliance with applicable law and regulation, including State licensure laws.
Surveyor Guidance:
Review the established requirements including education and experience required of the chief executive officer. This
may be in the form of a job description or other document that adequately describes the scope of responsibilities.
Verify that the governing body for the organization has appointed a chief executive officer and that he or she has
met the requirement for this role within the organization and that he or she is responsible for managing the entire
hospital.
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MEDICAL STAFF (MS)
MS.1 ORGANIZED MEDICAL STAFF
The hospital must have an organized medical staff that operates under bylaws approved by the governing body and
is responsible for the quality of medical care provided to patients by the hospital.
Interpretive Guidelines:
The hospital must have one medical staff for the entire hospital (including all campuses, provider-based locations,
satellites, remote locations, etc.). For example, a multi-campus hospital may not have a separately organized
medical staff for each campus. On the other hand, in the case of a hospital system, it is permissible for the system
to have a unified and integrated medical staff (hereafter referred to as a “unified medical staff”) for multiple,
separately certified hospitals. The medical staff must be organized and integrated as one body that operates under
one set of bylaws approved by the governing body. These medical staff bylaws must apply equally to all practitioners
within each category of practitioners at all locations of the hospital and to the care provided at all locations of the
hospital. The medical staff is responsible for the quality of medical care provided to patients by the hospital.
MS.2 ELIGIBILITY
SR.1 The governing body shall determine, in accordance with State law, which categories of practitioners
are eligible candidates for appointment to the medical staff. The medical staff must include doctors
of medicine or osteopathy. In accordance with State law, including scope-of-practice laws, the
medical staff may also include other categories of non-physician practitioners determined as eligible
for appointment by the governing body.
SR.2 The medical staff must examine the credentials of all eligible candidates for medical staff
membership and make recommendations to the governing body on the appointment of these
candidates in accordance with State law, including scope-of-practice laws, and the medical staff
bylaws, rules, and regulations.
SR.3 A candidate who has been recommended by the medical staff and who has been appointed by the
governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the
requirements contained in MS.2.
Interpretive Guidelines:
The hospital shall have an organized medical staff that is composed of fully licensed doctors of medicine or
osteopathy. In accordance with State law, the medical staff may also include other non-physician practitioners.
These other non-physician practitioners may include physician assistants, certified registered nurse anesthetists
(CRNA), advance practice registered nurses, midwives, psychologists, or other designated professionals who are
approved by the medical staff and governing body and eligible for appointment.
Surveyor Guidance:
Review documentation and verify that the governing body has determined and stated the categories of practitioners
who are eligible candidates for appointment to the medical staff.
Confirm that the governing body appoints all members to the medical staff in accordance with established policies
that have been based on the individual practitioner’s scope of clinical expertise and in accordance with Federal and
State law.
MS.3 ACCOUNTABILITY
SR.1 The medical staff shall be organized in a manner approved by and accountable to the governing body
and shall be responsible for the quality of the medical care provided to patients.
Interpretive Guidelines:
The medical staff shall be organized in a manner approved by and accountable to the governing body and shall be
responsible for the quality of the medical care provided to patients.
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All patients must be under the care of a member of the medical staff or under the care of a practitioner who is
directly under the supervision of a member of the medical staff. All patient care is provided by or in accordance with
the orders of a practitioner who meets the medical staff criteria and procedures for the privileges granted, who has
been granted privileges in accordance with those criteria by the governing body, and who is working within the scope
of those granted privileges.
Surveyor Guidance:
Verify that the governing body is accountable for the medical staff and the quality of patient care services. Validate
the process by which the governing body monitors these activities of medical staff members.
MS.4 RESPONSIBILITY
The responsibility for organization and conduct of the medical staff must be assigned to an individual doctor of
medicine or osteopathy or, when permitted by State law, a doctor of dental surgery or dental medicine or doctor of
podiatric medicine, when permitted by State law of the State in which the hospital is located.
SR.1 The governing body must consult directly with the individual assigned the responsibility for the
organization and conduct of the hospital’s medical staff, or his or her designee. At a minimum, this
direct consultation must occur periodically throughout the fiscal or calendar year and include
discussion of matters related to the quality of medical care provided to patients of the hospital. For a
multi-hospital system using a single governing body, the single multi-hospital system governing
body must consult directly with the individual responsible for the organized medical staff (or his or
her designee) of each hospital within its system in addition to the other requirements of 42 CFR
Section 482.12(a).
Interpretive Guidelines:
The medical staff must be accountable to the hospital’s governing body for the quality of medical care provided to
patients. The responsibility for organization and conduct of the medical staff must be assigned to an individual doctor
of medicine or osteopathy or, when permitted by State law, a doctor of dental surgery or dental medicine or doctor
of podiatric medicine, when permitted by State law of the State in which the hospital is located.
The governing body is expected to determine the number of consultations needed based on various factors specific
to the hospital, or to each of the hospitals within a multi-hospital system. These factors include, but are not limited
to, the scope and complexity of hospital services offered, specific patient populations served by a hospital, and any
issues of patient safety and quality of care that a hospital’s quality assessment and performance improvement
program might periodically identify as needing the attention of the governing body in consultation with its medical
staff. The hospital must also provide evidence that the governing body is appropriately responsive to any periodic
and/or urgent requests from the leader of the medical staff or designee for timely consultation on issues regarding
the quality of medical care provided to patients of the hospital. (79 FR 27112, May 12, 2014).
Per the Interpretive Guidelines of 42 CFR Section 482.12(a)(10), “it is expected that consultations occur at least
twice during either a calendar or fiscal year.”
Surveyor Guidance:
Validate the process by which the governing body monitors the quality of medical care provided to patients.
Verify that an individual doctor of medicine or osteopathy, a doctor of dental surgery or dental medicine or doctor of
podiatric medicine, when permitted by State law of the State in which the hospital is located, is responsible for the
conduct and organization of the medical staff.
Validate that the governing body consulted directly with the individual assigned the responsibility for the organization
and conduct of the hospital’s medical staff, or his or her designee periodically through the fiscal or calendar year.
SR.2 If a hospital is part of a hospital system consisting of multiple separately certified hospitals and the
system elects to have a unified and integrated medical staff for its member hospitals, after
determining that such a decision is in accordance with all applicable State and local laws, each
separately certified hospital must demonstrate that:
SR.2a The medical staff members of each separately certified hospital in the system (that is, all
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medical staff members who hold specific privileges to practice at that hospital) have voted
by majority, in accordance with medical staff bylaws, either to accept a unified and
integrated medical staff structure or to opt out of such a structure and to maintain a
separate and distinct medical staff for their respective hospital;
SR.2b The unified and integrated medical staff has bylaws, rules, and requirements that describe
its processes for self-governance, appointment, credentialing, privileging, and oversight, as
well as its peer review policies and due process rights guarantees, and which include a
process for the members of the medical staff of each separately certified hospital (that is,
all medical staff members who hold specific privileges to practice at that hospital) to be
advised of their rights to opt out of the unified and integrated medical staff structure after a
majority vote by the members to maintain a separate and distinct medical staff for their
hospital;
SR.2c The unified and integrated medical staff is established in a manner that takes into account
each member hospital’s unique circumstances and any significant differences in patient
populations and services offered in each hospital; and
SR.2d The unified and integrated medical staff establishes and implements policies and procedures
to ensure that the needs and concerns expressed by members of the medical staff, at each
of its separately certified hospitals, regardless of practice or location, are given due
consideration, and that the unified and integrated medical staff has mechanisms in place to
ensure that issues localized to particular hospitals are duly considered and addressed.
Interpretive Guidelines:
A hospital that is part of a system consisting of multiple separately certified hospitals may use a single unified and
integrated medical staff (hereafter referred to as a “unified medical staff”) that is shared with one or more of the
other hospitals in the system. In other words, as long as the requirements of §482.22(b)(4) are met, it is not
necessary for each separately-certified hospital within the system to have its own distinct medical staff organization
and structure, including hospital-specific medical staff bylaws, rules and requirements, hospital-specific medical staff
leadership, hospital-specific credentialing and peer review, etc. Instead, it may use one medical staff organization
and structure for
multiple hospitals, so long as all of the requirements of this section are met. However, separately certified hospitals
which share a single unified and integrated medical staff must also share a system governing body, in accordance
with the provisions of §482.12, since only one governing body may carry out the governing body’s medical staff
responsibilities for a unified medical staff.
Note that a multi-campus hospital that has several inpatient campuses that are provider- based, remote locations of
the hospital is not a multi-hospital system. A multi-campus hospital is one certified hospital, not several separately
certified hospitals. A multi- campus hospital may not have separate medical staffs at each campus, since each
hospital must have no more than one medical staff. A multi-campus hospital with one medical staff separate from
that of other certified hospitals is not employing a unified medical staff as that term is used in this regulation.
However, a multi-campus hospital that is part of a hospital system consisting of multiple separately certified
hospitals may share a unified medical staff with other separately certified hospitals within the system.
It should also be noted that a hospital system that includes certain types of hospitals, i.e., Hospitals-within-Hospitals
or Hospital Satellites, that are being paid under a Medicare payment system other than the Hospital Inpatient
Prospective Payment System (IPPS) might jeopardize the Medicare payment status of those excluded hospitals if it
owns both the tenant and host hospitals and uses a unified medical staff for both. This is the case even if the
requirements of §482.22(b)(4) are met. However, surveyors do not assess compliance with or enforce the Medicare
payment regulations that govern Hospitals- within-Hospitals or Hospital Satellites.
When granting practitioners privileges to provide patient care, a hospital’s governing body must specify those
hospitals in the system where the privileges apply, since, in addition to the qualifications of individual practitioners,
the services provided at each hospital must be considered when granting privileges. For example, psychiatric
hospitals do not offer surgical services, labor and delivery services, nuclear medicine, etc., so it would not be
appropriate for practitioners practicing in these areas to hold privileges at psychiatric hospitals in a multi-hospital
system that uses a unified medical staff.
Likewise if a multi-hospital system covers a wide geographic area, many of its practitioners may have no interest in
practicing on site at hospitals that are distant from their usual practice location(s). In addition, in order for the
acceptance or opt-out provisions of §482.22(b)(4)(i) and (ii) to be workable, privileges must be granted on a
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hospital-specific basis to practitioners who actually practice or are likely to practice at the hospital.
The governing body in a multi-hospital system must elect to exercise this option. Since a number of hospital systems
interpreted the Medical Staff CoP to permit a unified and integrated medical staff prior to publication of the final rule
at §482.22(b)(4) on May 12, 2014 or its effective date on July 11, 2014, the existence of a unified medical staff prior
to July 11, 2014 is considered evidence of the hospital’s governing body’s election of this option.
• This does not relieve the governing body of the responsibility to conduct a review of all applicable State and
local laws, including regulations, and make a determination that use of a unified medical staff that is shared by
multiple hospitals does not conflict with those laws. The hospital must maintain documentation of this determination
by its governing body.
• Nor does it relieve the governing body of the obligation to inform the medical staff of the right to vote to opt
out of a unified medical staff arrangement. (See discussion of §482.22(b)(4)(ii), which requires notification of all
members of this right. Failure to comply would be cited under the tag for §482.22(b)(4)(ii).)
If a hospital is part of a multi-hospital system that wishes to establish a unified medical staff for some or all of its
separately certified hospitals after the July 11, 2014 effective date of the final rule at §482.22(b)(4), then the
hospital’s system governing body must document in writing its decision to elect to use the unified medical staff
option, conditioned upon acceptance of a unified medical staff by the hospital’s medical staff in accordance with
§482.22(b)(4)(i).The governing body must also document its determination that such election does not conflict with
State or local laws, including regulations.
Surveyors are not expected, as part of their assessment of compliance with the Medicare CoPs, to evaluate whether
the governing body’s determination of compliance with State and local law is accurate. This would be handled by the
appropriate State or local authorities, or, if the State Survey Agency is the appropriate authority, under its State
licensure or other authority and not as part of a Federal survey.
MS.5 EXECUTIVE COMMITTEE
SR.1 The medical staff shall meet at regular intervals and minutes shall be maintained. If the medical
staff has an executive committee, a majority of the members of the committee shall be doctors of
medicine or osteopathy.
SR.2 The chief executive officer and the nurse executive of the organization or designee shall attend each
executive committee meeting on an ex-officio basis, with or without vote.
Surveyor Guidance:
Verify that the hospital has an executive committee and that the majority of members are doctors of medicine or
osteopathy. If an executive committee is in place, the chief executive officer and nurse executive (or designee) are
a part of the committee on an ex-officio basis.
Review meeting minutes of the executive committee to verify the participation of the medical staff, CEO and CNO (or
designee) attend these meetings.
MS.6 MEDICAL STAFF PARTICIPATION
The medical staff shall participate in at least the following organization activities:
SR.1 Medication management oversight;
SR.2 Infection prevention and control oversight;
SR.3 Tissue review;
SR.4 Utilization review;
SR.5 Medical record review; and,
SR.6 Quality Management System.
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SR.7 Reports and recommendations from these activities shall be prepared and shared with the medical
executive committee and the governing body.
Surveyor Guidance:
Verify through the review of minutes, data or other documentation that the medical staff participates in at least the
following activities of the organization:
•
Medication management oversight;
•
Infection control oversight;
•
Tissue review;
•
Utilization review;
•
Medical record review; and,
•
Quality Management System.
Sample reports and recommendations from these activities to verify that information, data and other documentation
are shared with the medical executive committee and the governing body and actions taken by medical staff and
governing body are evaluated to ensure implementation and effectiveness
MS.7 MEDICAL STAFF BYLAWS
SR.1 The medical staff shall be appointed by the governing body and operate under bylaws, rules and
regulations adopted and enforced by the medical staff and approved by the governing body.
SR.2 Changes to the medical staff bylaws, rules and regulations shall require approval of the medical staff
and the governing body.
SR.3 The medical staff bylaws shall describe the organization of the medical staff and include a statement
of the duties and privileges of each category of medical staff to ensure that acceptable standards are
met for providing patient care for all diagnostic, medical, surgical, and rehabilitative services.
SR.4 Medical staff bylaws shall include provisions for mechanisms for corrective action, including
indications and procedures for automatic and summary suspension of medical staff membership or
clinical privileges.
Interpretive Guidelines:
The governing body and medical staff must approve, adopt, and enforce medical staff bylaws rules and regulations in
accordance with State and Federal law to ensure that acceptable standards are met for providing patient care for all
diagnostic, medical, surgical, and rehabilitative services. The bylaws, rules and regulations shall define the duties
and privileges of each category for the medical staff. The bylaws shall also include a mechanism for corrective action
to include indications and procedures that define the process for automatic and summary suspension of the medical
staff as it relates to membership and clinical privileges.
Any changes made to the bylaws, rules and regulations will be approved by the medical staff and governing body.
Neither the medical staff nor governing body may unilaterally amend the bylaws, rules and regulations.
Surveyor Guidance:
Verify and review the medical staff bylaws, rules and regulations to ensure that are in accordance with Federal and
State laws and regulations. The bylaws should state or reference approval by the medical staff and governing body.
Review the process the hospital has defined for addressing how bylaws, rules and regulation revisions are made and
approved by the medical staff and governing body.
Verify that there are written criteria stated within the bylaws, rules and regulations that define the duties and
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privileges of each category for the medical staff in accordance with acceptable standards of care.
MS.8 APPOINTMENT
The medical staff bylaws shall describe the qualifications to be met by a candidate in order for the medical staff to
recommend that the governing body appoint the candidate. Those qualifications shall include the following:
SR.1 Initial appointment to the medical staff:
SR.1a Primary source verification of licensure, education, specific training, experience, (AMA
Master Profile or Osteopathic Physician Profile Report from American Osteopathic
Information Association is acceptable) and current competence;
SR.1a (1) Verification of ECFMG (as applicable);
SR.1b Current Federal Narcotics Registration Certificate (DEA) number (if required);
SR.1c Two peer recommendations;
SR.1d Review of involvement in any professional liability action; and,
SR.1e Receipt of database profiles from /through professional sources (e.g., AMA, AOA, NPDB,
OIG, Medicare/Medicaid Exclusions).
SR.2 Reappointment to the medical staff:
SR.2a Primary source verification of current licensure (AMA Master Profile or Osteopathic Physician
Profile Report from American Osteopathic Information Association is acceptable) and any
required certifications;
SR.2b Federal Narcotics Registration Certificate (DEA) number (if required);
SR.2c Review of involvement in any professional liability action; and,
SR.2d Review of individual performance data for variation from benchmark. Variation shall go to
Peer Review for determination of validity, written explanation of findings and, if appropriate,
an action plan to include improvement strategies (See MS.9).
SR.2e Receipt of database profiles from NPDB, OIG Medicare/Medicaid Exclusions.
Surveyor Guidance:
Sample records of medical staff appointments to determine that the governing body is involved in appointments of
medical staff members and the elements defined within this standard have been reviewed.
Verify that there are written criteria for appointments to the medical staff.
Review and verify the mechanism to examine credentials of individual prospective members (new appointments or
reappointments) by the medical staff.
MS.9 PERFORMANCE DATA
Practitioner specific performance data is required to be evaluated, analyzed and appropriate action taken as
necessary when variation is present and/or standard of care has not been met as determined by the medical staff.
Performance data will be collected periodically within the reappointment period or as required as a part of the peer
review process. This may include comparative and/or national data if available.
Areas required to be measured (as applicable) may include:
SR.1 Blood use (may include AABB transfusion criteria);
SR.2 Prescribing of medications: Prescribing patterns, trends, errors and appropriateness of prescribing
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for Drug Use Evaluations;
SR.3 Surgical Case Review: appropriateness and outcomes for selected high-risk procedures as defined by
the medical staff;
SR.4 Specific department indicators that have been defined by the medical staff;
SR.5 Anesthesia/ Moderate Sedation Adverse Events;
SR.6 Readmissions/ unplanned returns to surgery (as defined)
SR.7 Appropriateness of care for non-invasive procedures/interventions;
SR.8 Utilization data;
SR.9 Significant deviations from established standards of practice; and,
SR.10 Timely and legible completion of patients’ medical records.
SR.11 Any variant that should be analyzed for statistical significance.
Interpretive Guidelines:
The governing body must ensure that the medical staff is accountable to the governing body for the quality of care
provided to patients. The governing body must be provided with information (data) in order to evaluate the quality
of care provided to patients.
The hospital must define and measure the respective elements within this standard to generate a quality profile for
each medical staff member to be used for evaluation as a part of the appointment and reappointment process.
Surveyor Guidance:
Verify that the governing body is periodically apprised of the medical staff evaluation of patient care services
provided hospital wide using indicators and other measures as stated within this standard.
Sample medical staff quality (reappointment) profiles or other documentation to validate that this data is being
measured and a part of the appointment and reappointment process.
MS.10 CONTINUING EDUCATION
All individuals with delineated clinical privileges shall participate in continuing education that is at least in part
related to their clinical privileges.
SR.1 This documentation shall be considered in decisions about reappointment or renewal or revision of
clinical privileges.
SR.2 Action on an individual’s application for appointment/ reappointment or initial or subsequent clinical
privileges is withheld until the information is available and verified.
MS.11 GOVERNING BODY ROLE
SR.1 The governing body shall appoint members of the medical staff and approve clinical privileges after
considering the recommendations of the existing members of the medical staff and ensure that the
medical staff is accountable to the governing body for the quality of care provided to patients.
SR.2 The governing body may elect to delegate the authority to render initial appointment,
reappointment, and renewal or modification of clinical privileges decisions to a committee of the
governing body.
SR.3 The governing body shall ensure that under no circumstances is medical staff membership or
professional privileges in the organization dependent solely upon certification, fellowship, or
membership in a specialty body or society.
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SR.4 A complete application shall be acted on within a reasonable period of time, as specified in the
medical staff bylaws.
Interpretive Guidelines:
The governing body, with the advice of the medical staff, is responsible for the appointment and reappointment of
the individual practitioners of the medical staff and their respective delineation of privileges.
This process may be carried out by a committee that has been delegated by the governing body to oversee the
appointment and reappointment of medical staff members and their respective delineation of privileges. The process
for appointment and reappointment will be carried out within a reasonable timeframe as defined within the medical
staff bylaws.
The hospital cannot grant appointment, reappointment and allow privileges that are solely based upon certification,
fellowship, or membership in a specialty body or society.
Surveyor Guidance:
Verify the process for the appointment and reappointment of medical staff members. This process may be delegated
to a committee (e.g. Credentials Committee).
Verify the timeframe for the credentialing and privileging process to see that actions are taken as required in the
medical staff bylaws. Review a sampling of records of medical staff appointments to determine that the governing
body is involved in appointments of medical staff members and that privileges are not based solely based upon
certification, fellowship, or membership in a specialty body or society.
MS.12 CLINICAL PRIVILEGES
SR.1 The medical staff bylaws shall include criteria for determining the privileges to be granted to
individual practitioners and a procedure for applying the criteria to those individuals that request
privileges.
SR.2 Appointment or reappointments to the medical staff and the granting, renewal, or revision of clinical
privileges shall be made for a period defined by State law or if permitted by State law, not to exceed
three years.
SR.3 All individuals who are permitted by the organization and by law to provide patient care services
independently in the organization shall have delineated clinical privileges.
SR.4 There shall be a provision in the medical staff bylaws for a mechanism to ensure that all individuals
with clinical privileges provide services only within the scope of privileges granted.
SR.4a There shall be a provision to authorize Qualified Licensed Practitioners to order outpatient
services that are within their scope of service to order.
SR.5 If available and/or required by the medical staff to hold or maintain clinical privileges, include a
review of individual performance data variation from criteria determined by the medical staff to
identify need for training or proctoring that may be required.
SR.6 The medical staff bylaws shall provide a mechanism for consideration of automatic suspension of
clinical privileges in any of the following instances:
SR.6a Revocation/restriction of professional license;
SR.6b Revocation/suspension/probation of Federal Narcotics Registration Certificate(DEA);
SR.6c Failure to maintain the specified amount of professional liability insurance; or,
SR.6d Non-compliance with written medical record delinquency or deficiency requirements.
SR.7 The medical staff bylaws shall provide a mechanism for immediate and automatic suspension of
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clinical privileges due to the termination or revocation of the practitioner’s Medicare or Medicaid
status.
SR.8 The medical staff bylaws shall contain fair hearing and appeal provisions for any adverse actions
regarding the appointment, reappointment, suspension, reduction, or revocation of privileges of any
individual who has applied for or has been granted clinical privileges.
Interpretive Guidelines:
The medical staff must develop criteria for determining the privileges to be granted to individual practitioners. These
criteria must be included in the bylaws. There must also be a procedure in place to ensure that these criteria have
been met prior to privileges being granted. The medical staff bylaws will govern the process to ensure that services
are provided by practitioners only within their scope of granted privileges.
The medical staff will define the criteria and have a mechanism for consideration of automatic suspension of clinical
privileges of a practitioner at a minimum when:
•
The practitioner’s professional license has been revoked or suspended for any reason;
•
The practitioner’s DEA certificate has been revoked, suspended or on probation for any reason;
•
The practitioner has failed to maintain the minimum specified amount of professional liability
insurance as required in the medical staff bylaws; and,
•
Written medical record delinquency or deficiency requirements have not been met.
The medical staff will also have a written mechanism for immediate and automatic suspension of clinical privileges
due to the termination or revocation of the practitioner’s Medicare or Medicaid status.
For any adverse actions regarding the appointment, reappointment, suspension, reduction or revocation of privileges
of any individual who has applied for or has been granted clinical privileges, there will be a mechanism that provides
the practitioner a fair hearing and appeal process. Once this process is complete, the medical staff will document the
findings and resolutions in writing.
Surveyor Guidance:
Review and verify that the medical staff bylaws contain criteria for granting clinical privileges to individual
practitioners and that a procedure exists for applying these criteria.
Review and verify the defined circumstances for withdrawing, suspending, or terminating privileges of an individual
practitioner.
Verify the process in place to ensure practitioners only provide care to patients within the scope of the privileges
granted by the governing body.
Review and verify the process for fair hearing and appeals and follow the documentation for an example of how this
process was carried out by the medical staff.
MS.13 TEMPORARY CLINICAL PRIVILEGES
When dictated by urgent patient care need or when an application is complete without any negative or adverse
information before action by the medical staff or governing body, the chief executive officer, or designee, may grant
temporary clinical privileges:
SR.1 On the recommendation of a member of the medical executive committee, president of the medical
staff, or medical director (as defined by the medical staff);
SR.2 For a period of time not to exceed 120 days.
SR.3 Criteria for granting temporary privileges:
SR.3a Primary verification of education (AMA/AOA Profile is acceptable);
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SR.3b Demonstration of current competence;
SR.3c Primary verification of State professional licenses;
SR.3d Receipt of professional references (including current competence); and,
SR.3e Receipt of database profiles from AMA, AOA, NPDB, and OIG Medicare/Medicaid Exclusions.
SR.4 The medical staff bylaws shall include a process for approving practitioners for care of patients in the
event of an emergency or disaster.
SR.5 If the organization provides medical staff services through use of locum tenens or similar temporary
medical service that may be used for a period not to exceed six months; the medical staff will define
within the medical staff bylaws the process regarding the approval of physicians and other
practitioners providing such services. The medical staff will complete the required credentialing and
privileging requirements defined by the medical staff.
Interpretive Guidelines:
Under certain circumstances, such as urgent patient care need or when an application is complete without any
negative or adverse information, the medical staff and governing body may not be able to take immediate action on
approving the privileges of a practitioner. Under these circumstances, the chief executive officer, or designee, may
grant temporary clinical privileges on the recommendation of a member of the medical executive committee,
president of the medical staff, or medical director (as defined by the medical staff), for a period of time not to
exceed 120 days.
The minimum criteria as defined under MS.13, SR.3 will apply for granting temporary privileges.
Surveyor Guidance:
Review and verify that the hospital has a process in place to grant temporary privileges and the circumstances when
this process may be completed.
Sample records and supporting documentation where a practitioner has been granted temporary privileges to
validate the process that was followed.
MS.14 CORRECTIVE OR REHABILITATION ACTION
The medical staff bylaws shall provide a mechanism for management of medical staff corrective or rehabilitative
action. This documented action may result from unprofessional demeanor and conduct and/or this behavior is likely
to be detrimental to patient safety or the delivery of quality care or is disruptive to organization operations. Any
officer of the medical staff, the CEO, or any officer of the board may initiate this corrective or rehabilitative action.
Interpretive Guidelines:
There may be circumstances when a practitioner has been determined to have acted in an unprofessional manner or
has presented signs of impairment that would prevent him/her from carrying out patient care safely or disrupting the
operations of the organization. The medical staff must provide a mechanism for managing the process for taking
corrective or rehabilitative action when a practitioner’s conduct is in question. An officer of the medical staff, CEO,
or any officer of the board may initiate the process for corrective or rehabilitative action.
The medical staff shall define examples of circumstances or criteria for applying the process for implementing
corrective or rehabilitative action.
All hospital staff should be instructed in the process to follow when a practitioner is conducting him/herself in an
unprofessional manner or present signs of impairment that would jeopardize the safety and quality of patient care.
Surveyor Guidance:
Review and verify that the medical staff bylaws address the mechanism for managing practitioners when corrective
or rehabilitative action may be required.
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Verify that the hospital has defined the circumstances when corrective or rehabilitative action may be taken.
Sample records and supporting documentation of a practitioner who has been subject to corrective and rehabilitative
action and the process followed in order to promote patient safety and the quality of care provided.
MS.15 ADMISSION REQUIREMENTS
Patients are admitted to the organization only on the recommendation of a licensed practitioner permitted by the
State to admit patients to the organization.
SR.1 The governing body shall ensure that every patient is under the care of a:
SR.1a Doctor of medicine or osteopathy who may delegate such care to other qualified health care
professionals to the extent allowed by State law;
SR.1b Doctor of dental surgery or dental medicine who is legally authorized to practice dentistry
by the State and who is acting within the scope of his/her license;
SR.1c Doctor of podiatric medicine, only with respect to functions authorized by the State;
SR.1d Doctor of optometry who is legally authorized to practice optometry by the State;
SR.1e Chiropractor who is licensed by the State and legally authorized to perform the services of a
chiropractor, but only with respect to treatment by means of manual manipulation of the
spine to correct a subluxation demonstrated by x-ray to exist; or,
SR.1f Clinical psychologist (doctoral degree in psychology), but only with respect to clinical
psychologist services as defined in 42 CFR §410.71 and only to the extent permitted by
State law.
SR.2. The governing body shall ensure that:
SR.2a A doctor of medicine or osteopathy is on duty or on call at all times; and,
SR.2b A doctor of medicine or osteopathy is responsible for the care of each patient with respect
to any medical or psychiatric problem that is present on admission or develops during
hospitalization and is not within the scope of practice of the licensed practitioners specified
in MS.15, SR 1b-1f as that scope of practice is defined by the medical staff and State law.
Interpretive Guidelines:
The hospital may admit patients only on the recommendation of a licensed practitioner permitted by the State. The
governing body is responsible for ensuring that every patient admitted is under the care of licensed practitioner (as
defined by MS.15, SR.1).
The governing body must ensure that a doctor of medicine or osteopathy is on duty or on call at all times. The
governing body must also ensure a doctor of medicine or osteopathy is responsible for the care of each patient with
respect to any medical or psychiatric problem that is present on admission or develops during hospitalization and is
not within the scope of practice of the licensed practitioners specified in MS. 15, SR 1b-1f as that scope of practice is
defined by the medical staff and State law.
Surveyor Guidance:
Review the Medical Staff Bylaws, Rules and Regulations to verify that admitting privileges are limited to practitioners
who have been approved by the medical staff and governing body and as permitted by State law.
Although the practitioners that are licensed and permitted by State law to admit patients, in some organizations, the
admission of patients must be done under the service of specific practitioners as defined in the medical staff bylaws,
rules and regulations. Verify the organization’s process for addressing these admission requirements to ensure that
patients are admitted under the appropriate service.
The medical staff bylaws, rules and regulations will define which practitioners by category (i.e. Active, Associate,
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Courtesy, Consulting, etc.) staff may admit patients. Verify that admitting privileges are limited to those
practitioners holding the appropriate status with the Medical Staff.
Verify that the governing body has established and monitors the enforcement of policies to ensure an MD or DO is on
duty or on call at all times. The medical staff will normally distribute an “on-call” schedule of practitioners by service.
Verify how such a list is communicated to appropriate departments/ units throughout the hospital.
If non-MD/ DOs admit patients, verify that every patient is being monitored by an MD/ DO who is responsible for any
medical or psychiatric problem outside the scope of practice of the admitting practitioner.
MS.16 MEDICAL RECORD MAINTENANCE
SR.1 The medical staff bylaws shall include the requirement for the preparation and maintenance of a
complete and accurate medical record for each patient and policies and procedures for dealing with
medical record delinquencies.
SR.2 The medical staff bylaws shall require that the medical staff have periodic meetings at regular
intervals to review and analyze medical records of the patients for adequacy and quality of care.
Interpretive Guidelines:
The medical staff shall require that the preparation and maintenance of complete and accurate medical records be in
place for each patient. There should be defined policies and procedures for dealing with medical record
delinquencies.
The process for medical records completion and the actions taken must be enforced by hospital policy.
In order to ensure that there is an effective process in place, the medical staff must regularly review and analyze
medical records to ensure the adequacy and quality of patient care.
Surveyor Guidance:
Review and verify that the process and respective policies and procedures are in place for addressing medical record
delinquency.
Review and validate that the hospital has a means of determining its medical record delinquency rate and how this is
defined.
Validate the enforcement of the medical staff by laws, policies and procedures for practitioners’ delinquent in medical
records completion.
Review and verify that the medical staff meets regularly to review and analyze medical records for the adequacy and
quality of care provided. The medical staff shall maintain minutes or other records to verify the scope of the reviews
conducted and the subsequent actions taken to address any findings.
MS.17 HISTORY AND PHYSICAL
SR.1 The medical staff bylaws shall include a requirement that a medical history and physical examination
(H&P) for each patient shall be completed and documented in the medical record no more than 30
days before or 24 hours after an admission or registration, and prior to any high-risk procedure,
surgery, procedures requiring anesthesia services, or other procedures requiring an H&P, and placed
in the patient’s medical record within 24 hours after admission. The H&P must be in the medical
record prior to any high-risk procedure, surgery or other procedure requiring anesthesia services.
SR.1a An H&P completed within 30 days prior to admission or registration shall include an update
entry in the medical record documenting an examination for any change in the patient’s
current medical condition completed by a doctor of medicine or osteopathy, oromaxillofacial
surgeon or other qualified individual who has been granted these privileges by the medical
staff in accordance with State law.
SR.1b Any H&P update of the patient’s current medical condition shall document:
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SR.1b(i) That the patient has been examined;
SR.1b(ii) That the H&P has been reviewed;
SR.1b(iii) Any changes in the patient’s condition, or,
SR.1b(iv) That ‘‘no change’’ has occurred in the patient’s condition since the H&P was
completed.
SR.1c This examination and update of the patient’s current medical condition shall be completed
and placed in the medical record within 24 hours after admission or registration, and prior
to surgery or other procedure requiring anesthesia services.
SR.2 A doctor of medicine or osteopathy, oromaxillofacial surgeon shall perform the H&P described above.
Alternatively, a physician’s assistant or advance practice nurse may perform an H&P if permitted by
State law and scope of practice.
SR.3 The content of the HP examination and applicability shall be determined by the medical staff and
may be done by the individuals described in MS.17, SR. 2. The content of the H&P examination will
be determined by an assessment of the patient’s condition and any co-morbidities in relation to the
reason for admission or surgery. This H&P examination must be in the medical record prior to any
high-risk procedure, surgery, or other procedure requiring anesthesia services and within 24 hours of
admission or registration as stated in MS.17, SR.1.
Interpretive Guidelines:
The medical record must be completed by an authorized practitioner and contain an H&P as required for all
inpatients and applicable outpatients. The H&P must be performed no more than 30 days prior to admission (or
procedure or service that requires a H & P) or within 24 hours after admission, and prior to any high-risk procedure,
surgery, procedures requiring anesthesia services, or other procedures requiring an H&P.
The H&P must be placed in the patient’s medical record within 24 hours of admission and prior to any high-risk
procedure, surgery, procedures requiring anesthesia services or other procedures requiring an H&P. (or procedure or
service that requires an H&P). In the event that the H & P is completed within 30 days prior to admission, the
hospital must ensure that this H&P is updated to document any changes in the patient’s condition.
If there are no changes to the H&P as documented, the physician or qualified licensed practitioner can simply
document an update note stating that:
•
The H&P has been reviewed,
•
The patient has been examined, and,
•
The physician or qualified licensed practitioner concurs with the findings of the H&P completed on the
specified date or that ‘‘no change’’ has occurred in the patient’s condition since the H&P was
completed.
The practitioner completing the update is responsible for ensuring that the H&P that is documented in the medical
record is complete and accurate.
The completed H&P would be authenticated by the practitioner who conducted the H&P.
Authentication includes dating and timing of this medical record entry. Therefore, it is not necessary to document the
time the H&P was physically placed in the medical record.
For the purposes of this requirement, the term ‘‘admission’’ applies to any admission regardless of whether care is
being provided on an inpatient or outpatient basis.
A doctor of medicine or osteopathy or alternatively, a qualified licensed practitioner, may perform a history and
physical, if so privileged by the medical staff and permitted by State law and scope of practice. If the patient is
admitted only for oral or maxillofacial surgery, the H&P may be performed by an oral and maxillofacial surgeon who
has been granted such privileges by the medical staff, in accordance with State law.
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If a short form H&P is used, the minimal content and applicability must be determined by the medical staff. This
short form H&P may be used for non-inpatients and be completed by the individuals described above. Without
exception, the H&P must be in the medical record prior to any high-risk procedure, surgery, procedure requiring
anesthesia services, or other procedures requiring an H&P.
Surveyor Guidance:
Determine that the medical records contain an H&P completed for each patient by an authorized practitioner.
Request and review a sampling of open and closed medical records for verification of completion of the H&P should
include, but not be limited to:
•
Surgical patients
•
At least one per in-patient unit or clinical tracer
•
Moderate/conscious sedation
•
Procedures requiring an H&P by hospital policy
In a sampling of patient medical records, verify that the completion of the H&P was within the specified time frame
and appropriate documentation noted.
•
Verify the content and completeness of the H&P per organization policy.
•
In some cases, the organization may accept an H&P that has been completed in a practitioner’s office.
When this is allowed, verify the process for ensuring that the appropriate documentation is present
and completed per the requirements of the organization and that the H&P was completed within the
required timeframe.
•
Verify that the H&P was completed no more than 30 days before or 24 hours after admission or
registration and, in all cases involving surgery or procedures requiring anesthesia services or
moderate/conscious sedation, prior to the surgery or procedure.
Verify that this documentation of the H&P was placed in the medical record within 24 hours after admission or
registration, and prior to any high-risk procedure, surgery, procedure requiring anesthesia services, or other
procedures requiring an H&P.
Where the H&P is completed within 30 days before admission or registration and in all cases involving surgery or
procedures requiring anesthesia services or moderate/conscious sedation, the hospital must ensure that this H&P is
updated to document any changes in the patient’s condition.
•
If there are no changes to the H&P as written, the physician or qualified licensed practitioner can
simply document an update note stating that:
•
The H&P has been reviewed,
•
The patient has been examined, and
•
The physician or qualified licensed practitioner concurs with the findings of the H&P completed
on the specified date or that ‘‘no change’’ has occurred in the patient’s condition since the
H&P was completed.
MS.18 CONSULTATION
The medical staff shall define in its bylaws the circumstances and criteria under which consultation or management
by a physician or other qualified licensed independent practitioner is required.
Surveyor Guidance:
Review and verify the circumstances and criteria which require consultation or management by a physician or other
qualified licensed independent practitioner.
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MS.19 AUTOPSY
SR.1 The medical staff shall attempt to secure autopsies in all cases of unusual deaths and those of
medical-legal and educational interest.
SR.2 Mechanisms for documenting permission to perform an autopsy shall be defined.
SR.3 There shall be a system for notifying the medical staff and specifically the attending practitioner
when an autopsy is being performed.
Surveyor Guidance:
Verify that the medical staff has policies requiring practitioners to attempt to secure permission to perform autopsies
in cases involving unusual deaths and those of medical-legal or educational interest.
Verify that there is a mechanism for documenting how permission is given to perform an autopsy.
For autopsies performed, validate the process for notifying the attending practitioner when it was performed. Verify
that the medical staff has a process to review autopsies taking place within the hospital.
MS.20 TELEMEDICINE
SR.1 When telemedicine services are furnished to the hospital’s patients through an agreement with a
distant-site telemedicine entity, the governing body of the hospital whose patients are receiving the
telemedicine services may choose, in lieu of the requirements in MS.8, to have its medical staff rely
upon the credentialing and privileging decisions made by the distant-site telemedicine entity when
making recommendations on privileges for the individual distant-site physicians and practitioners
providing such services, if the hospital’s governing body ensures, through its written agreement with
the distant-site telemedicine entity, that the distant-site telemedicine entity furnishes services that,
in accordance with requirements stated above, permit the hospital to comply with all applicable
conditions of participation for the contracted services. The hospital’s governing body must also
ensure, through its written agreement with the distant-site telemedicine entity, that all of the
following provisions are met:
SR.1a The distant-site telemedicine entity’s medical staff credentialing and privileging process and
standards at least meet the standards stated in 42 CFR 482.12(a) and 482.22(a).
SR.1b The individual distant-site physician or practitioner is privileged at the distant-site
telemedicine entity providing the telemedicine services, which provides the hospital with a
current list of the distant-site physician’s or practitioner’s privileges at the distant-site
telemedicine entity.
SR.1c The individual distant-site physician or practitioner holds a license issued or recognized by
the State in which the hospital whose patients are receiving such telemedicine services is
located.
SR.1d With respect to a distant-site physician or practitioner, who holds current privileges at the
hospital whose patients are receiving the telemedicine services, the hospital has evidence of
an internal review of the distant-site physician’s or practitioner’s performance of these
privileges and sends the distant-site telemedicine entity such performance information for
use in the periodic appraisal of the distant-site physician or practitioner. At a minimum,
this information must include all adverse events that result from the telemedicine services
provided by the distant-site physician or practitioner to the hospital’s patients, and all
complaints the hospital has received about the distantsite physician or practitioner.
SR.2 When telemedicine services are furnished to the hospital’s patients through an agreement with a
distant-site hospital, the governing body of the hospital whose patients are receiving the
telemedicine services may choose, in lieu of the requirements of MS.8, to have its medical staff rely
upon the credentialing and privileging decisions made by the distant-site hospital when making
recommendations on privileges for the individual distant-site physicians and practitioners providing
such services, if the hospital’s governing body ensures, through its written agreement with the
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distant-site hospital, that all of the following provisions are met:
SR.2a The distant-site hospital providing the telemedicine services is a Medicare-participating
hospital.
SR.2b The individual distant-site physician or practitioner is privileged at the distant-site hospital
providing the telemedicine services, which provides a current list of the distant-site
physician’s or practitioner’s privileges at the distant-site hospital.
SR.2c The individual distant-site physician or practitioner holds a license issued or recognized by
the State in which the hospital whose patients are receiving the telemedicine services is
located.
SR.2d With respect to a distant-site physician or practitioner, who holds current privileges at the
hospital whose patients are receiving the telemedicine services, the hospital has evidence of
an internal review of the distant-site physician’s or practitioner’s performance of these
privileges and sends the distant-site hospital such performance information for use in the
periodic appraisal of the distant-site physician or practitioner. At a minimum, this
information must include all adverse events that result from the telemedicine services
provided by the distant-site physician or practitioner to the hospital’s patients and all
complaints the hospital has received about the distant-site physician or practitioner.
SR.3 The Medical Staff will define and apply criteria for determining the privileges to be granted to
individual practitioners and a procedure for applying the criteria to individuals requesting privileges.
For distant-site physicians and practitioners requesting privileges to furnish telemedicine services
under an agreement with the hospital, the criteria for determining privileges and the procedure for
applying the criteria are also subject to these requirements.
Interpretive Guidelines:
While hospitals may use third-party credentialing verification organizations to compile and verify the credentials of
practitioners applying for privileges, the hospital’s governing body is still legally responsible for all privileging
decisions.
Telemedicine is the provision of clinical services to patients by practitioners from a distance via electronic
communications.
A distant-site telemedicine entity is one that: Provides telemedicine services;
•
Is not a Medicare-participating hospital (therefore, a non-Medicare-participating hospital that provides
telemedicine services would be considered a distant-site telemedicine entity also); and,
•
Provides contracted services in a manner that enables a hospital using its services to meet all
applicable CoPs and NIAHO
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accreditation requirements, particularly those requirements related to
the credentialing and privileging of practitioners providing telemedicine services to the patients of a
hospital.
Note: Cross reference to GB.3 SR 4-5
Surveyor Guidance:
Review agreements with any distance-site telemedicine providers.
Verify the process in place for review and approval of credentialing documentation and other information provided.
Review the process for granting and approval of privileges for the telemedicine physicians and practitioners.
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NURSING SERVICES (NS)
NS.1 NURSING SERVICE
SR.1 The organization must have a well-organized nursing service with a plan of administrative authority
and delineation of responsibilities for delivery of patient care.
SR.2 There shall be 24-hour nursing services and a registered nurse must supervise and evaluate the
nursing care for each patient. A registered nurse or licensed practical nurse shall be on duty at all
times except in facilities that have been granted a waiver in accordance with 42 CFR §488.54(c),
Federal law, rules or regulations.
SR.3 The nursing service must develop and maintain a procedure to ensure that nursing personnel for
whom licensure is required have a valid and current licensure. Nursing services must be provided or
supervised by a registered nurse.
SR.4 There shall be adequate numbers of licensed registered nurses, licensed practical nurses,
supervisory, and other staff to provide nursing care to all patients as needed. A registered nurse
must be immediately available for the bedside care of every patient, as required by State law.
SR.5 A registered nurse shall make any decisions regarding delegation of nursing care to other nursing
staff, based on individual patient need and staff qualifications.
SR.6 Non-employee licensed nurses who are working in the organization must adhere to the policies and
procedures of the organization. The director of nursing service must provide for the adequate
supervision and evaluation of the clinical activities of non-employee nursing personnel that occur
within the responsibility of the nursing service.
Interpretive Guidelines:
The hospital must have an organized nursing service and must provide on-site nursing services 24 hours a day,
seven days a week with at least one registered nurse providing or supervising the service 24 hours a day, 7 days a
week.
Exception: Small rural hospitals operating under a waiver as discussed in the CMS Conditions of Participation Section
§482.23(b) (1).
Nursing services are required to be furnished to inpatients by the hospital. The hospital is required to have a
registered nurse on duty at all times (unless the exception applies as a small rural hospital under waiver).
A registered nurse must make all patient care assignments. The nurse executive and the hospital are responsible for
ensuring that nursing personnel with the appropriate competence, qualifications and skills have been assigned to
provide nursing care for each patient to meet their care needs.
If services are provided by contracted (non-employee) staff, the nurse executive must supervise and evaluate the
clinical activities being performed by these individuals. Non-employee staff are required to adhere to the policies and
procedures of the organization and will receive an orientation regarding the organization’s policies and procedures
prior to working on-site for the organization.
Staffing:
The hospital must provide nursing services 24 hours a day, 7 days a week. An LPN/LVN can provide nursing services
if an RN supervises that care. The RN must be immediately available for the bedside care of those patients,
Exception for small and rural hospitals: CMS Conditions of Participation Section 488.54 sets forth certain conditions
under which rural hospitals of 50 beds or fewer may be granted a temporary waiver of the 24-hour registered nurse
requirement by the regional office. The hospital must have met the criteria for this exception to apply.
Definitions:
“Rural” is defined, as all areas not delineated as “urbanized” areas by the Census Bureau, in the most recent census.
“Temporary” is defined as a one year period or less and the waiver cannot be renewed.
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Surveyor Guidance:
Interview the nurse executive. The following may be requested prior to meeting the nurse executive:
•
Organizational chart(s) for nursing services for all locations where the hospital provides nursing
services;
•
Job descriptions or description of responsibilities for all nursing personnel including the nurse
executive.
The organization will have multiple patient care units. Sample at least one job description from each of these units.
During the review of the organization, observe the nursing care in progress to determine how adequate staffing is
determined as it applies to the delivery of care.
Review samples of the following documentation:
•
Staffing schedules;
•
Unit assignment sheets;
•
Nursing policies and procedures; and,
•
Internal survey and staffing variance reports.
Interview patients to verify how nursing care has been provided. Secure hospital and patient permission before the
interviews.
Review the nurse-staffing schedule (or similar documentation to apply staff) for a minimum of a one-week period. If
minimal or less than desired staffing for the period is noted, review additional nurse-staffing schedules for a second
week period to identify any patterns or trends for insufficient staffing.
Verify that nursing assignments include consideration of the complexity of the patient’s care needs and that the
nursing staff that care for the patients are competent and have the required qualifications.
Review the process for determining how nursing assignments and staffing are applied in the patient care setting.
This process should encompass the following:
•
Patient needs;
•
Acuity of patients;
•
Special needs of individual patients; and,
•
Competence and qualifications of nursing personnel.
Verify the daily RN coverage for every unit of the hospital to determine that at least one RN for each unit and shift is
on duty 24/7.
(Exception for small and rural hospitals: CMS Conditions of Participation 42 CFR Section 488.54 sets forth certain
conditions under which rural hospitals of 50 beds or fewer may be granted a temporary waiver of the 24-hour
registered nurse requirement by the CMS regional office.)
The following must have been met in order for the waiver to have been granted:
•
50 or fewer inpatient beds;
•
The character and seriousness of the deficiencies do not adversely affect the health and safety of
patients; and,
•
The hospital meets all the other statutory requirements in section 1861(e) (1-8) of the Social Security
Act.
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In order for the waiver to be granted, the hospital has made and continues to make a good faith effort to comply
with the 24-hour nursing requirement.
When contracted (non-employee) personnel are used by the organization, these individuals must adhere to the
practices, policies and procedures of the organization. Verify the process for orienting these contracted individuals to
the hospital, unit(s) they are assigned to, policies and procedures, documentation requirements (particularly if a
computerized medical record is utilized), and mandatory requirements for safety and emergency procedures to be
followed.
Competency requirements will vary unit to unit within the organization. Determine the means by which competence
is verified for the contracted individual(s) prior to their working in the organization. The competency requirements
for contracted staff should be comparable to employed staff performing these similar duties. Verify there is
appropriate supervision from qualified hospital employed staff for these contracted individuals.
Verify the process for evaluation of contract staff for monitoring of performance and how this information is shared
with the individual and contracted agency.
Review the recruitment efforts and methods used by the hospitals’ administration by requesting copies of materials
and demonstration of other methods to meet the nursing staff needs for the hospital.
Compare the hospital salaries with those offered from other facilities in the area.
If a nursing shortage exists, determine if it is a temporary shortage of qualified nursing personnel in the area or
attributable to other reasons and how the hospital is addressing the issue.
NS.2 NURSE EXECUTIVE
SR.1 The nurse executive must be a licensed registered nurse with either a master degree, actively
pursuing a master’s degree or equivalent experience in comparable positions.
SR.2 The nurse executive is responsible for the operation of the service, including determining the types
and numbers of staff necessary to provide nursing care for all patient care areas of the organization
and standards of nursing practice.
SR.3 The nurse executive is responsible for the development, approval and implementation of all nursing
service policies and procedures.
Interpretive Guidelines:
The nurse executive is a member of senior leadership and must be appropriately qualified. The nurse executive must
have a nursing master’s degree, or is actively pursuing a nursing master’s degree, or can demonstrate the
equivalent experience in comparable positions. The hospital may have only one nursing service hospital-wide and
one single nurse executive.
Operation of service:
The nursing service must ensure that patient needs are met. This includes ongoing assessments of patients’ needs
and nursing staff is provided to meet those needs.
The nurse executive must be a currently licensed RN and he/she is responsible for the operation of the nursing
service, including the quality of patient care provided by the nursing service.
The nurse executive must determine the sufficient numbers, types, and qualifications of supervisory and staff
nursing personnel to meet the appropriate nursing needs and care of the patient population of each department or
nursing unit.
Appropriate staffing and personnel for patient care units is described in NS.1 (See staffing under Interpretive
Guidelines)
Although specific titles may vary, the hierarchy of the nursing service will include some variation of:
•
Assistant/Associate Directors(s)
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•
Supervisors/Coordinators
•
Head Nurses/Nurse Managers
•
Staff Nurses
•
Unit Secretaries/Clerks
•
Nursing Assistants/Aides
Surveyor Guidance:
Review the nurse executive’s job description. Verify that he or she has the appropriate education, licensure and
experience for this position in the organization for operation of the nursing service.
Verify that the nurse executive determines appropriate staffing and personnel for patient care units as described in
NS.1 (See staffing under Interpretive Guidelines and Surveyor Guidance).
Review the organizational chart or plan for nursing services. Determine that the chart or plan describes or displays
lines of authority that delegates responsibility within the department or nursing unit.
Verify that the nurse executive is involved in the development of and approves the nursing service patient care
policies and procedures.
Evaluate the nursing service to ensure that it is appropriate according to the following:
•
Physical layout and size of the hospital;
•
Number of patients;
•
Intensity of illness and nursing needs;
•
Availability of nurses’ aides and assistants and other support processes are provided (e.g.,
housekeeping services, unit secretaries); and,
•
Training and experience of personnel.
NS.3 ASSESSMENT AND PLAN OF CARE
SR.1 The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for
each patient. Nursing staff shall develop and maintain a plan of care for each patient within 24 hours
of admission that reflects the findings of a completed nursing assessment and input of other
disciplines, as appropriate. The nursing care plan may be part of an interdisciplinary care plan.
SR.2 Nursing staff shall complete an assessment of a patient’s condition within twenty-four hours of
admission to an inpatient setting.
SR.2a The nursing assessment will include but not be limited to:
SR.2a(i) Allergies
SR.2a(ii) Admitting problem
SR.2a(iii) History of pain and current status
SR.2a(iv) Preexisting or other conditions (i.e. Pregnancy, COPD, Diabetes)
SR.2a(v) Current medications (what time last dose, including any illicit drugs)
SR.2a(vi) ADL needs
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SR.2a(vii) Dietary Requirements
SR.2a(viii) All other requirements per hospital nursing policies
SR.2b Nursing staff will complete an assessment according to the hospital nursing policies in all
other areas of the organization (Outpatient, clinics, surgical centers etc.).
SR.3 Nursing staff will reassess the patient at regular time defined intervals and if the patient’s condition
changes.
SR.3a The patient’s plan of care is reviewed and revised, at regular intervals and as necessary,
when the patient’s condition has changed.
Interpretive Guidelines:
A nursing assessment will be completed within 24 hours of admission to an inpatient setting and according to
hospital policies in other areas of the organization such as clinics, outpatient surgery etc. While the list of
requirements to be included in the initial nursing assessment is specific, the complete nursing assessment should
reflect the philosophy of the nursing department on patient care. The use of nursing diagnosis, pathways, or clinical
guidelines are allowed and encouraged if they meet the minimum requirements. All nursing assessments should
collect enough data for the nurse to be able to develop a plan of care to keep the patient safe and address the
presenting and relevant concomitant conditions.
A plan of care begins within 24 hours of admission of the patient. The plan of care includes planning the patient’s
care from admission through discharge and the respective care processes involved. If interdisciplinary findings are
indicated, these shall also be a part of the plan of care and documented in the medical record.
The plan of care is based on assessing the patient’s nursing care needs (not solely those needs related to the
admitting diagnosis) and developing appropriate goals, nursing interventions in response to those needs, and
evaluate the patient’s progress toward those goals.
The plan of care is maintained and updated based upon ongoing assessments of the patient’s needs and the patient’s
response to interventions, in response to assessments.
The plan of care is included as a part of the patient’s medical record.
Surveyor Guidance:
Select a sample of medical records to review the following:
•
Nursing assessments;
•
Nursing re-assessments;
•
Nursing care plans and updates, as indicated;
•
Nursing notes, and,
•
Medication administrations records (MARs).
This should be a part of the review for each inpatient area visited. In evaluation of the plan of care, the following will
be reviewed:
•
The plan has been developed within 24 hours of inpatient admission for each patient;
•
The plan reflects findings of the assessments and outlines the patient goals and as appropriate
includes both, physiological and psychosocial factors;
•
The discharge planning process has been initiated;
•
The plan is consistent with the attending MD/DO’s plan for medical care;
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•
The plan includes reference/inclusion to interdisciplinary assessments (as applicable); and,
•
The plan is revised as the needs of the patient changes.
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STAFFING MANAGEMENT (SM)
SM.1 LICENSURE OR CERTIFICATION
The organization shall have a policy and practice for outlining and verifying that each staff member possesses a valid
and current license or certification as required by the organization and Federal and State law. This written policy
shall be strictly enforced and compliance data reported to Quality Management Oversight.
Surveyor Guidance:
Review and validate the hospital’s policy and practice for performing primary verification of the current licensure
and/or certification of all staff members as required by the organization, and Federal and State law.
Review the process in place to enforce compliance and that data regarding verification and expirations is shared with
Quality Management Oversight and/or Human Resources (Personnel) as needed, if this process is completed at the
individual department level).
SM.2 PROFESSIONAL SCOPE
All staff, including contract staff, students, and volunteers, shall function within the limits of their scope of service as
defined by their professional practice act, State law, and/or organization policy at all times. This written policy shall
be strictly enforced and variations reported to Quality Management Oversight.
Surveyor Guidance:
Review the policy and verify that the hospital has a means of ensuring that all staff, including contract staff,
students, and volunteers are functioning within the limits of their scope of service as it has been defined by the
hospital, respective professional practice acts and State law.
Verify the process for communicating any variations from provided services to Quality Management Oversight.
SM.3 DEPARTMENT SCOPE OF SERVICE
Each department, whether clinical or supportive, and each patient unit, shall have a written scope of service that
includes at least:
SR.1 The hours of operation;
SR.2 Patient populations served;
SR.3 Skill mix;
SR.4 Core staffing and methods for determining and modifying staffing to meet patient or process needs;
and,
SR.5 Description of assessment and reassessment practices, including timeframes.
SR.6 Organization policies will identify how often, and under what circumstances, each department’s
scope of service must be reviewed and updated (i.e. if new service is added or discontinued, change
of population served, etc.).
Interpretive Guidelines:
The hospital will have a description of the scope of services provided, whether clinical or supportive, and each patient
unit. This scope of service will address the following:
•
The hours of operation;
•
Patient populations served;
•
Skill mix;
•
Core staffing and methods for determining and modifying staffing to meet patient or process needs;
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and, Description of assessment and reassessment practices, including timeframes.
The hospital will describe and illustrate the sequence and interaction of these processes (services).
Surveyor Guidance:
Verify that the hospital has a description of the scope of services provided for all services including clinical or
supportive, and encompasses each patient unit.
Verify that the scopes of service include the items listed above within the Interpretive Guidelines.
Review the documents and/or illustration that describe the sequence and interaction of these processes (services).
SM.4 DETERMINING AND MODIFYING STAFFING
SR.1 The method for determining and modifying staffing shall be validated through periodic reporting of
variance from core staffing, outlining justification and linking that justification with patient and
process outcomes, including any untoward patient events or process failures.
SR.2 This validation shall be done and reported to Quality Management Oversight, when indicated.
Interpretive Guidelines:
The hospital will develop a method for determining and modifying staffing. Staffing will be validated through periodic
reporting of variance from core staffing, and outline the justification and link for that justification with patient and
process outcomes, including any untoward patient events or process failures. Validation of the measures regarding
the impact of staffing on processes will be reported to Quality Management Oversight, when indicated.
Surveyor Guidance:
Review and verify the method(s) used by the hospital for determining and modifying staffing when indicated.
Validate that there is a means in place for reporting variances and other associated information to Quality
Management Oversight.
SM.5 JOB DESCRIPTION
All staff, whether clinical or supportive, including contract staff, students and volunteers shall have a current job
description (or job responsibilities) available that contains the experience, educational and physical requirements,
supervision (as indicated) and performance expectations for that position.
Surveyor Guidance:
Review and verify a sampling of job descriptions to verify that the hospital has identified the appropriate experience,
educational and physical requirements and performance expectations for the positions reviewed. This includes
contracted staff for nursing and/or other areas of the organization.
SM.6 ORIENTATION
All staff, whether clinical or supportive, including contract staff, students and volunteers, shall receive an orientation
to specific job duties and responsibilities, and their work environment, as required by Federal and State law and
regulation and the organization. The orientation shall take place prior to the individual functioning independently in
their job.
SR.1 Members of the medical staff will receive an orientation developed and approved by the organization
that includes general safety practices, emergency procedures, infection control, confidentiality and
other issues as required by the organization.
Interpretive Guidelines:
The hospital will require that all staff, including contract staff, students and volunteers receive an orientation prior to
working independently in their respective roles for the hospital.
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This orientation will address, at a minimum, the following topics:
•
Organizational structure;
•
Patient confidentiality and ethics;
•
Document control, retrieval and verification (specific to policies, procedures, and work
instructions/protocols);
•
Internal reporting requirements for adverse patient events;
•
Patient safety;
•
General safety (work environment);
•
Emergency procedures;
•
Infection control and universal precautions; and,
•
Other issues as required by the hospital and Federal and State law and regulation.
Orientation to specific job duties may be addressed within the department or service where the employee is
assigned, but completed prior to the employee working independently.
Verify the process in place for members of the medical staff completing a general orientation as noted within SM.6,
SR.1.
SM.7 STAFF EVALUATIONS
SR.1 The performance/competency evaluation shall contain indicators that will objectively measure the
ability of staff to perform all job duties as outlined in the job description. Relevant indicators may be
selected from the list of indicators for measurement as outlined below.
SR.2 The staff shall be evaluated initially and on an on-going basis against indicators that measure issues
and opportunities for improvement. The measures selected may be considered from the following:
SR.2a Variations and problem processes identified through the analysis of outcomes measurement
as required by the QMS;
SR.2b High-risk, low volume procedures;
SR.2c New technology/equipment/processes;
SR.2d Customer satisfaction feedback;
SR.2e Scheduled training session outcomes;
SR.2f Staff learning needs assessments that include variations identified through prior staff
performance measurement;
SR.2g Staff feedback;
SR.2h Medical staff feedback;
SR.2i Requirements of Federal or State law; and,
SR.2j Other indicators as determined by the organization.
SR.3 Indicator measurement for contract staff may be modified based on organization outcomes and
frequency of service of individuals. Modification of this measurement(s) will be made when needed
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and shall be justified by data analysis.
SR.4 The organization shall aggregate objective performance data from sources that may include;
individual evaluations, incident reports, risk management, staff and patient feedback, and/or data
analysis to identify variations for further training, coaching, and mentoring.
SR.4a Reassessment of objective data shall follow any intervention.
SR.4b The outcomes of this aggregated data will be reported to Quality Management Oversight as
needed to monitor staff performance improvement.
SR.5 The organization shall have a policy and procedure for sharing results of individual performance
evaluations/competence assessment with staff members that allows for staff feedback within a
timeframe defined by the organization, not to exceed one calendar year.
SR.6 The organization shall require each staff member, including contract staff, to participate in continuing
education as required by individual licensure/certification, professional association, law or regulation,
or organization policy. Compliance with this standard shall be reported to Quality Management
Oversight.
Interpretive Guidelines:
The hospital must continually evaluate the performance/competency of staff. This process of evaluation must include
the use of indicators that will objectively measure the ability of staff to perform all job duties as outlined in the job
description. These indicators may address one or more of the following:
•
Variations and problem processes identified through the analysis of outcomes measurement as
required by the QMS;
•
High-risk, low volume procedures;
•
New technology/equipment/processes;
•
Customer satisfaction feedback;
•
Scheduled training session outcomes;
•
Staff learning needs assessments that include variations identified through prior staff performance
measurement;
•
Staff feedback;
•
Medical staff feedback; and,
•
Requirements of Federal or State law.
The hospital will have a policy and procedure for sharing results of individual performance evaluations/competence
assessment with staff members that allows for staff feedback within a timeframe defined by the organization, not to
exceed one calendar year.
The hospital may modify indicator measurement for contract staff based on organization outcomes and frequency of
service of individuals. This measurement modification will be made when needed and shall be justified by data
analysis.
The organization shall aggregate the objective performance data from sources that may include; individual
evaluations, incident reports, risk management, staff and patient feedback, and/or data analysis to identify
variations for further training, coaching, and mentoring.
In order to continually improve the fulfillment of their job responsibilities, the hospital shall require each staff
member, including contract staff, to participate in continuing education as required by individual
licensure/certification, professional association, law or regulation, or hospital policy.
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Surveyor Guidance:
In a sampling of personnel records, verify that the hospital has a performance/competency evaluation process that
includes appropriate measures as stated within the Interpretive Guidelines for SM.7.
Verify the policy and practice the hospital uses to validate the competency of staff occurs within a specified
timeframe no less than once per calendar year.
Verify the policy and practice that the hospital uses to measure contract staff performance is based upon outcomes
and frequency of service.
Verify that the hospital requires and makes provisions for each staff member, including contract staff, to participate
in continuing education as required by individual licensure/certification, professional association, law or regulation, or
hospital policy.
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MEDICATION MANAGEMENT (MM)
MM.1 MANAGEMENT PRACTICES
SR.1 The organization shall have a pharmacy service with written policies and procedures to ensure
effective medication management practices that meet the needs of the patients. These policies must
address storage, handling, dispensing, and administration of drugs and biologicals within the
organization. Medications will be prepared and administered in accordance with accepted
professional principles.
SR.2 The pharmacy service will be directed by a full time, part time, or consulting registered pharmacist
responsible for developing, supervising, and coordinating all the activities of the pharmacy services.
The pharmacy service must have an adequate number of qualified personnel to ensure effective
medication management services, including emergency services.
SR.3 Drugs and biologicals must be prepared and administered in accordance with Federal, State and local
requirements, recommendations of professional organizations and accepted standards of practice
(e.g., ASHP, USP, ISMP), and the orders of the practitioner or practitioners responsible for the
patient's care as specified under 42 CFR Section 482.12(c), and,
SR.3a Drugs and biologicals may be prepared and administered on the orders of other
practitioners not specified under 42 CFR Section 482.12(c) only if such practitioners are
acting in accordance with State law, including scope-of-practice laws, hospital policies, and
medical staff bylaws, rules, and regulations.
SR.3b Drugs and biologicals may be prepared and administered on the orders contained within
pre-printed and electronic standing orders, order sets, and protocols for patient orders only
if such orders meet the requirements of 42 CFR Section 482.24(c)(3).
SR.3c All drugs and biologicals must be administered by, or under supervision of, nursing or other
personnel in accordance with Federal and State laws and regulations, including applicable
licensing requirements, and in accordance with the approved medical staff policies and
procedures.
SR.4 All compounding, packaging, and dispensing of medication shall be under the supervision of a
pharmacist.
SR.4a All personnel involved in the compounding of pharmaceuticals shall receive training and
evaluation based upon the complexity of the compounding performed.
SR.4b The hospital must develop a written training program that describes the required training,
frequency, and the process for evaluating the performance of individuals involved in sterile
compounding.
SR.4c The hospital must establish and follow written Standard Operating Procedures (SOPs) for
compounded sterile preparation (CSP). The SOPs must ensure that the entire compounding
operation is well designed, functions as designed, and will yield CSPs that are safe for
administration to patients.
SR.5 All drugs and biologicals must be controlled, secured and distributed in accordance with applicable
standards of practice and consistent with Federal and State law at all times.
SR.5a Drugs listed as Schedule II, III, IV, and V of the Comprehensive Drug Abuse Prevention and
Control Act of 1970 must be kept locked within a secure area.
SR.5b Only personnel authorized by the pharmacy service shall have access to locked areas.
SR.6 Outdated, mislabeled, or otherwise unusable medications shall not be available for patient use.
SR.7 Medications prescribed without specific duration or number of doses shall automatically be stopped
after a reasonable time that has been predetermined by the medical staff.
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SR.8 Blood transfusions and intravenous medications must be administered in accordance with State law
and approved medical staff policies and procedures.
SR.9 The hospital may allow a patient (or his or her caregiver/support person where appropriate) to self
administer both hospital-issued medications and the patient's own medications brought into the
hospital, as defined and specified in the hospital's policies and procedures. If the hospital allows a
patient to self administer specific hospital-issued medications, then the hospital must have policies
and procedures in place to:
SR.9a Ensure that a practitioner responsible for the care of the patient has issued an order,
consistent with hospital policy, permitting self-administration.
SR.9b Assess the capacity of the patient (or the patient's caregiver/support person where
appropriate) to self-administer the specified medication(s).
SR.9c Instruct the patient (or the patient's caregiver/support person where appropriate) in the
safe and accurate administration of the specified medication(s).
SR.9d Address the security of the medication(s) for each patient.
SR.9e Document the administration of each medication, as reported by the patient (or the
patient's caregiver/support person where appropriate), in the patient's medical record.
SR.9f If the hospital allows a patient to self-administer his or her own specific medications
brought into the hospital, then the hospital must have policies and procedures in place to:
SR.9f (1) Ensure that a practitioner responsible for the care of the patient has issued an
order,
consistent with hospital policy, permitting self-administration of
medications the patient brought into the hospital.
SR.9f (2) Assess the capacity of the patient (or the patient's caregiver/support person
where
appropriate) to self-administer the specified medication(s), and also
determine if the patient (or the patient's caregiver/support person where
appropriate) needs instruction in the safe and accurate administration of the
specified medication(s).
SR.9f (3) Identify the specified medication(s) and visually evaluate the medication(s) for
integrity.
SR.9f (4) Address the security of the medication(s) for each patient.
SR.9f (5) Document the administration of each medication, as reported by the patient (or
the
patient's caregiver/support person where appropriate), in the patient's
medical record.
SR.10 Hospitals may use pre-printed and electronic standing orders, order sets, and protocols for patient
orders only if the hospital:
SR.10a Establishes that such orders and protocols have been reviewed and approved by the
medical staff and the hospital's nursing and pharmacy leadership;
SR.10b Demonstrates that such orders and protocols are consistent with nationally recognized and
evidence based guidelines;
SR.10c Ensures that the periodic and regular review of such orders and protocols is conducted by
the medical staff and the hospital's nursing and pharmacy leadership to determine the
continuing usefulness and safety of the orders and protocols; and
SR.10d Ensures that such orders and protocols are dated, timed, and authenticated promptly in the
patient's medical record by the ordering practitioner or by another practitioner responsible
for the care of the patient only if such a practitioner is acting in accordance with State law,
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including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and
regulations.
Interpretive Guidelines:
The organization must have a system that ensures that drugs and biologicals are managed in a manner that is safe
and appropriate, and that its pharmacy system provides all drugs and biologicals prescribed by the organization’s
practitioners in a timely manner for administration to its patients.
All medication management practices, including preparation and administration, shall be administered by or under
the supervision of nursing or other qualified personnel in accordance with applicable Federal and State laws. Drugs
and biologicals must be prepared and administered in accordance with Federal and State laws.
Federal law regulates the approval and classification of drugs and biologicals. Individual States establish laws and
regulations which specify the scope of practice for various types of licensed healthcare professionals, including which
medications they may prescribe and administer, including controlled substances.
Orders of the practitioner or practitioners responsible for the patient’s care:
In accordance with standard practice, all practitioner orders for the administration of drugs and biological must
include at least the following:
•
Name of the patient;
•
Age and weight of the patients, or other dose calculation requirements, where applicable;
•
Date and time of the order;
•
Drug name;
•
Dose, frequency, and route;
•
Exact strength or concentration, when applicable;
•
Quantity and/or duration, when applicable;
•
Specific instructions for use, when applicable; and,
•
Name of the prescriber.
Accepted Standards of Practice:
Hospital policies and procedures for the preparation and administration of all drugs and biologicals must not only
comply with all applicable Federal and State laws, but also must be consistent with accepted standards of practice
based on guidelines or recommendations issued by nationally recognized organizations with expertise in medication
preparation and administration (e.g., ASHP, USP, ISMP).
The organization shall have a pharmacy service administered in accordance with accepted professional principles and
directed by a full time, part time, or consulting registered pharmacist responsible for developing, supervising, and
coordinating all the activities of the pharmacy services.
Accepted professional principles include compliance with applicable Federal and State law and adherence to
standards or guidelines for pharmaceutical services and medication administration issued by nationally recognized
professional organizations, including, but not limited to: U.S. Pharmacopeia (www.usp.org ), the American Society of
Health-System Pharmacists (http://www.ashp.org/ ), the Institute for Safe Medication Practices
(http://www.ismp.org/default.asp ), the National Coordinating Council for Medication Error Reporting and Prevention
(www.nccmerp.org ); the Institute for Healthcare Improvement (http://www.ihi.org/ihi); or the Infusion Nurses
Society (http://www.ins1.org).
Direction of pharmaceutical services may not require continuous on-premise supervision at the hospital’s single
pharmacy or at any pharmacy location but may be accomplished through regularly scheduled visits, and/or
telemedicine in accordance with Federal and State law and regulations and accepted professional principles.
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The pharmaceutical services staff must be sufficient in types, numbers, and training to provide quality services,
including twenty-four (24) hour, seven (7) day emergency coverage. In the alternative, there must be an
arrangement for emergency services, as determined by the needs of the patients and as specified by the medical
staff and within the scope and complexities of services provided.
All compounding, packaging, and dispensing of medication shall be under the supervision of a licensed pharmacist.
Only the pharmacy compounds or admixes all sterile medications, intravenous admixtures, or other drugs except in
emergencies or when not feasible (for example, when there is a need for emergency or immediate patient
administration of a compounded sterile preparation).
Staff that participate in the compounding of pharmaceuticals will be trained and exhibit competence in understanding
the standard operating procedures (SOPS). Procedures will include: access to the compounding area,
decontamination procedure for supplies, cleaning of carts and the environment, use of personnel protective
equipment, materials allowed in compounding areas, cleaning of work surfaces, certification and proper use of
primary engineering controls, proper disposal of supplies, and safe handling of hazardous supplies.
All medications (listed as Schedule II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of
1970) must be kept and locked in a secured container and/or room. In the event these drugs are stored in a
container that is readily portable, it must be stored in a locked room, monitored location, or secured location that will
ensure their security when not in use. Only personnel authorized by the pharmacy service shall have access to
locked areas.
The hospital must have a pharmacy labeling, inspection, and inventory management system that ensures that
outdated, mislabeled, or otherwise unusable medications are not available for patient use.
A drug or biological is outdated after its “beyond-use date” (BUD), which may be reached before the expiration date,
but never later. The BUD takes into account the specific conditions and potential for deterioration and microbial
growth that may occur during or after the original container is opened, while preparing the medication for dispensing
and administration, and/or during the compounding process if it is a compounded medication.
The hospital will ensure that medications prescribed without specific duration or number of doses shall automatically
be stopped after a reasonable time that has been predetermined by the medical staff.
Medication security:
•
Drugs and biologicals are stored in accordance with manufacturer’s directions and State and Federal
requirements.
•
Hospital policies and procedures need to define which personnel are authorized to have access to
locked areas based on their own needs as well as State and Local law.
•
Non-controlled drugs and biologicals are to be stored in a secure area in a manner that prevents
tampering and diversion.
•
A medication is considered secure if unauthorized individuals are prevented from obtaining access.
•
A secure area is one in which staff are actively providing patient care or preparing to receive patients
with procedures to ensure limited entry and exit to appropriate staff, patients, and visitors.
•
This includes critical care areas or labor and delivery suites which actively provide patient care around
the clock and the operating room when staffed and providing care.
•
All non-controlled substances are to be locked when a patient care area is not staffed.
•
When not in use, an operating room would not be considered secure and all drugs and biologicals are
expected to be locked.
Medical Staff Approved Policies and Procedures:
The hospital’s medical staff must approve policies and procedures for medication administration, consistent with the
requirements of Federal and State law and accepted standards of practice. It is recommended that the medical staff
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consult with nurses, pharmacists, Quality Assessment and Performance Improvement program staff, and others in
developing these policies and procedures. The adopted policies and procedures must address key issues related to
medication administration, which include but are not limited to:
•
Personnel Authorized to Administer Medication.
•
Policies and procedures must identify categories of licensed personnel and the types of medications
they are permitted to prepare and administer, in accordance with state laws. The policies and
procedures must also address education and training for all personnel preparing and administering
drugs and biologicals.
•
Medication preparation and administration education and training is typically included in hospital
orientation or other continuing education for nursing staff and other authorized healthcare
personnel. Training or continuing education topics regarding medication preparation and
administration may include but are not limited to the following:
•
Safe handling and preparation of authorized medications;
•
Knowledge of the indications, side effects, drug interactions, compatibility and dose limits of
administered medications;
•
Equipment, devices, special procedures, and/or techniques required for medication administration;
As appropriate, patients may need to self-administer non-controlled drugs and biologicals; the hospital will authorize
the patient to have access to these medications. (Such non-controlled medications may include i.e. nitroglycerine
tablets and inhalers). The provision for patient self-administration would also include other nonprescription
medications at the bedside (i.e. lotions, creams, and/or rewetting eye drops. The hospital will have policies and
procedures in place regarding patient self-administration of non-controlled drugs and biologicals consistent with safe
medication practices. There will be measures in place to properly secure such non-controlled drugs and biologicals.
The policies and procedures will define the means for determining the competence to self-administer such drugs and
biologicals and provide education to the patient as necessary to ensure safe self-administration of these drugs and
biologicals.
Policies and procedures address:
•
Personnel authorized to administer medications
•
Security and monitoring of carts or emergency boxes, locked or unlocked, containing drugs and
biologicals in all patient care areas to ensure their safe storage, availability in emergency situations,
and patient safety. Medications brought to the hospital by patients and their families
•
Sample Medications
•
Investigational medications
•
Practices to minimize and prevent medication errors based on professional standards of practice
including;
•
Proactive review and analysis of external alerts, internal practice variances and adverse drug events
•
Labeling of medications
•
High-alert medications - dosing limits, administration guidelines, packaging, labeling and storage
•
Guidelines/criteria for selection from a menu of medication options addressing similar indications for
use e.g. pain meds
•
Limiting the variety of medication-related devices and equipment. For Example: limit the types of
general purpose infusion pumps to one or two
•
Availability of up-to-date medication information
•
Availability of pharmacy expertise. Pharmacist available on-call when pharmacy does not operate 24
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hours a day
•
Avoidance of dangerous abbreviations
•
Alert systems for look-like and sound-alike drug names
•
Use of facility approved pre-printed order sheets whenever possible
•
That orders to “resume previous orders” are prohibited
•
A voluntary, non-punitive, reporting system to monitor and report adverse drug events (including
medication errors and adverse drug reactions)
•
The preparation, distribution, administration and proper disposal of hazardous medications
•
Drug recalls
•
That patient-specific information is readily accessible to all individuals involved in provision of
pharmaceutical care. The patient information must be sufficient to properly order, prepare,
dispense, administer and monitor medications as appropriate
•
Identification of when weight-based dosing is required; (e.g., pediatric dosing, chemo, contrast, etc.)
•
Other relevant performance improvement activities
Basic safe practices for medication administration:
The hospital’s policies and procedures must reflect accepted standards of practice that require the following be
confirmed prior to each administration of medication:
•
Patient identity. Acceptable patient identifiers include but are not limited to: the patient’s full name;
an identification number assigned by the hospital; or date of birth. Identifiers must be confirmed by
patient wrist band, patient identification card, patient statement (when possible) or other means
outlined in the hospital’s policy. The patient’s identification must be confirmed to be in agreement
with the medication administration record and medication labeling prior to medication
administration to ensure that the medication is being given to the correct patient.
•
Correct medication, to ensure that the medication being given to the patient matches that prescribed
for the patient;
•
Correct dose, to ensure that the dosage of the medication matches the prescribed dose, and that the
prescription itself does not reflect an unsafe dosage level (i.e., a dose that is too high or too low);
•
Correct route, to ensure that the method of administration – orally, intramuscular, intravenous, etc.,
is the appropriate one for that particular medication and patient; and
•
Appropriate time, to ensure adherence to the prescribed frequency and time of administration.
Timing of Medication Administration:
Appropriate timing of medication administration must take into account the complex nature and variability among
medications; the indications for which they are prescribed; the clinical situations in which they are administered; and
the needs of the patients receiving them. The chemical properties, mechanism of action, or therapeutic goals of
some medications require administration at the exact time prescribed, or within a narrow window of its prescribed
scheduled time, to avoid compromising patient safety or achievement of the intended therapeutic effect. However,
the therapeutic effect of many other medications is uncompromised by a much broader window of time for
administration. Consequently, the application of a uniform required window of time before or after the scheduled
time for the administration of all medications, without regard to their differences, could undermine the ability of
nursing staff to prioritize nursing care activities appropriately. This could also result in staff work-arounds that
jeopardize patient safety due to the imposition of unrealistic or unnecessary time constraints for medication
administration. Instead, hospital policies and procedures must specifically address the timing of medication
administration, based on the nature of the medication and its clinical application, to ensure safe and timely
administration. The policies and procedures must address at least the following:
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•
Medications not eligible for scheduled dosing times;
•
Medications eligible for scheduled dosing times;
•
Administration of eligible medications outside of their scheduled dosing times and windows; and
Evaluation of medication administration timing policies, including adherence to them.
Medications not eligible for scheduled dosing times:
The policies and procedures must identify medications which are not eligible for scheduled dosing times, either in
general or in specific clinical applications. These are medications that require exact or precise timing of
administration, based on diagnosis type, treatment requirements, or therapeutic goals. The policies and procedures
must reflect consideration of factors including, but not limited to, the pharmacokinetics of the prescribed medication;
specific clinical applications; and patient risk factors. Examples of medications that hospitals may choose to identify
as not eligible for scheduled dosing times may include, but are not limited to:
•
Stat doses (immediate);
•
First time or loading doses (initial large dose of a drug given to bring blood, tissue or fluid levels to an
effective concentration quickly);
•
One-time doses; doses specifically timed for procedures;
•
Time-sequenced doses; doses timed for serum drug levels;
•
Investigational drugs; or
•
Drugs prescribed on an as needed basis (PRN doses).
The policies and procedures must ensure timely administration of such medications. In addition they must specify if
the policy for the administration of these medications will be applied hospital-wide or only for specific diagnosis
types, hospital units, or clinical situations.
Medications eligible for scheduled dosing times:
Medications eligible for scheduled dosing times are those prescribed on a repeated cycle of frequency, such as once a
day, BID (twice a day), TID (three times a day), hourly intervals (every 1, 2, 3, or more hours), etc. The goal of this
scheduling is to achieve and maintain therapeutic blood levels of the prescribed medication over a period of time.
Medication administration policies and procedures typically establish standardized dosing times for the administration
of all ‘scheduled’ medications. For example, medications prescribed for BID (twice a day)
administration might, under a given hospital’s policies and procedures, be scheduled to be administered at 8am and
8pm. Another hospital might choose to schedule BID medications at 7:30 am and 7:30 pm. Use of these
standardized times facilitates the medication administration process, e.g., by providing to the hospital’s pharmacy
that morning doses of all BID drugs must be dispensed and delivered to patient units in time for the scheduled
administration. For the nursing staff, the scheduled administration time might prompt prioritization of additional
activities that may be required, in the case of particular drugs, such as vital sign assessment or the collection and
review of blood work, to ensure safe and timely medication administration.
Policies and procedures for medications eligible for scheduled dosing times must also address: first dose
medications, including parameters within which nursing staff are allowed to use their own judgment regarding the
timing of the first and subsequent doses, which may fall between scheduled dosing times; retiming of missed or
omitted doses; medications that will not follow scheduled dosing times; and patient units that are not subject to
following the scheduled dosing times.
Time-critical scheduled medications:
Time-critical scheduled medications are those medications for which an early or late administration of greater than
thirty minutes might cause harm or have significant, negative impact on the intended therapeutic or pharmacological
effect. Accordingly, scheduled medications identified under the hospital’s policies and procedures as time-critical
must be administered within thirty minutes before or after their scheduled dosing time, for a total window of 1 hour.
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It is possible for a given medication to be time-critical for some patients, due to diagnosis, clinical situation, various
risk factors, or therapeutic intent, but not time-critical for other patients. Therefore, hospital policies and procedures
must address the process for determining whether specific scheduled medications are always time- critical, or only
under certain circumstances, and how staff involved in medication administration will know when a scheduled
medication is time-critical. Examples of time-critical scheduled medications/medication types may include, but are
not limited to:
•
Antibiotics;
•
Anticoagulants;
•
Insulin;
•
Anticonvulsants;
•
Immunosuppressive agents;
•
Pain medication;
•
Medications prescribed for administration within a specified period of time of the medication order;
Medications that must be administered apart from other medications for optimal therapeutic effect;
Medications prescribed more frequently than every 4 hours.
Non-time-critical scheduled medications:
Non-time critical scheduled medications are those for which a longer or shorter interval of time since the prior dose
does not significantly change the medication’s therapeutic effect or otherwise cause harm. For such medications
greater flexibility in the timing of their administration is permissible. Specifically:
•
Medications prescribed for daily, weekly or monthly administration may be within 2 hours before or
after the scheduled dosing time, for a total window that does not exceed 4 hours.
•
Medications prescribed more frequently than daily, but no more frequently than every 4 hours, may
be administered within 1 hour before or after the scheduled dosing time, for a total window that
does not exceed 2 hours.
Missed or late administration of medications:
The hospital’s policies and procedures must address the actions to be taken when medications eligible for scheduled
dosing times are not administered within their permitted window of time. This includes doses which may have been
missed due to the patient being temporarily away from the nursing unit, for example, for tests or procedures;
patient refusal; patient inability to take the medication; problems related to medication availability; or other reasons
that result in missed or late dose administration. Likewise, policies and procedures must also outline guidelines for
the administration and timing of new medications which are initiated between standardized dosing times.
These policies and procedures must identify parameters within which nursing staff are allowed to use their own
judgment regarding the rescheduling of missed or late doses and when notification of the physician or other
practitioner responsible for the care of the patient is required prior doing so. In either case, the reporting of
medication errors that are the result of missed or late dose administration must be reported to the attending
physician immediately in accordance with requirement MM.6, SR.3.
Evaluation of medication administration timing policies:
Hospitals must periodically evaluate their medication administration timing policies, including staff adherence to the
policies, to determine whether they assure safe and effective medication administration. Medication errors related to
the timing of medication administration must be tracked and analyzed to determine their causes. Based on the
results of the evaluations of the policies and the medication administration errors, the medical staff must consider
whether there is a need to revise the policies and procedures governing medication administration timing.
Standing orders:
Hospitals may adopt policies and procedures that permit the use of standing orders to address well- defined clinical
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scenarios involving medication administration. The policies and procedures must address the process by which a
standing order is developed; approved; monitored; initiated by authorized staff; and subsequently authenticated by
physicians or practitioners responsible for the care of the patient.
The specific criteria for a nurse or other authorized personnel to initiate the execution of a particular standing order
must be clearly identified in the protocol for the order, i.e., the specific clinical situations, patient conditions, or
diagnoses in which initiating the order would be appropriate. Policies and procedures must address the education of
the medical, nursing, and other applicable professional staff on the conditions and criteria for using standing orders
and the individual staff responsibilities associated with their initiation and execution.
An order that has been initiated for a specific patient must be added to the patient’s medical record at the time of
initiation, or as soon as possible thereafter. Likewise, standing order policies and procedures must specify the
process whereby the physician or other practitioner responsible for the care of the patient acknowledges and
authenticates the initiation of all standing orders after the fact, with the exception of influenza and pneumococcal
vaccines, which do not require such authentication in accordance with 42 CFR §482.23(c)(3).
The policies and procedures must also establish a process for monitoring and evaluating the use of standing orders,
including proper adherence to the order’s protocol. There must also be a process for the identification and timely
completion of any requisite updates, corrections, modifications, or revisions.
Surveyor Guidance:
Verify that the pharmacist is properly licensed and is a full-time or part-time employee or employed on a
consultative basis.
Review and verify the job description or written agreement to see that the responsibilities of the pharmacist are
clearly defined and include development, supervision, and coordination of all the activities of pharmacy services.
Verify that the pharmacy director is actively involved in those committees responsible for establishing medication
related policies and procedures.
Verify that the pharmaceutical services are provided by staff sufficient in number and training to provide quality
services, including 24 hour, 7-day emergency coverage, or there is an arrangement for emergency services, as
determined by the needs of the patients and as specified by the medical staff.
In review of the pharmacy, review the process for the preparation and administration of medications. Verify that
medications are prepared and administered in accordance with Federal and State laws, accepted national standards
of practice, manufacturer’s directions, and hospital policy.
Verify that there is an effective method for the administration of drugs. Use the following indicators for assessing
drug administration:
Verify that there are policies and procedures approved by the medical staff covering who is authorized to administer
medications and that the policies are followed.
Verify that nursing staff authorized to administer drugs and biological are practicing within their State-permitted
scope of practice.
Are personnel other than nursing personnel administering drugs or biologicals? If yes, determine if those personnel
are administering drugs or biologicals in accordance with Federal and State laws and regulations.
Verify that there are policies and procedures approved by medical staff addressing the timing of medication
administration.
Verify that the hospital has, consistent with its policies, identified medications which are:
•
Not eligible for scheduled dosing times;
•
Eligible for scheduled dosing times and are time-critical; and
•
Eligible for scheduled dosing times and are not time-critical.
Verify the hospital has established total windows of time that do not exceed the following:
•
1 hour for time-critical scheduled medications
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•
2 hours for medications prescribed more frequently than daily, but no more frequently than every 4
hours; and 4 hours for medications prescribed for daily or longer administration intervals.
Verify that the hospital’s policy describes requirements for the administration of identified time-critical medications.
Is it clear whether time-critical medications or medication types are identified as such for the entire hospital or are
unit-, patient diagnosis-, or clinical situation- specific?
Review a sample of medical records to determine whether medication administration conformed to a practitioner’s
order (i.e., that the correct medication was administered to the right patient at the right dose via the correct route,
and that timing of administration complied with the hospital’s policies and procedures.) Check that the practitioner’s
order was still in force at the time the drug was administered.
Observe the preparation of drugs and their administration to patients [medication pass] in order to verify that
procedures are being followed:
•
Verify that a patient’s identity is confirmed prior to medication administration.
•
Verify that procedures to assure the correct medication, dose, and route are followed.
•
Verify that drugs are administered in accordance with the hospital’s established policies and
procedures for timely medication administration.
•
Observe if the nurse remains with the patient until medication is taken.
•
Review the process followed when medications are not given on time and what action(s) are taken
Interview personnel who administer medication to verify their understanding of the policies regarding timeliness of
medication administration:
•
Verify that the staff are able to identify time-critical and non-time-critical scheduled medications as
well as medications not eligible for scheduled dosing times.
•
Verify that the staff are able to describe requirements for the timing of administration of time critical
and nontimed critical medications in accordance with the hospital’s policies.
If the hospital uses standing orders, verify that there are policies and procedures that address the process by which
a standing order is developed; approved; monitored; initiated by authorized staff; and subsequently authenticated
by physicians or practitioners responsible for the care of the patient.
Review one or more standing orders involving medication administration, including the documentation on the
development of the order, evidence of training of personnel on the order’s protocol, and periodic evaluation of the
use of the standing order, including adherence to policies.
Interview nursing staff to determine whether they initiate medications in accordance with standing orders. Are they
following the policies and procedures?
In a sampling of patient records, review and verify medication orders (and the ordering process), medication
administration records, and appropriate medication related documentation in the medical record.
Review a sample of medication administration records (MARs) to verify that they conform to practitioner’s orders,
that the order is current and that the drug and dosage are correct and administered as ordered.
Review the unit dose system utilized in the pharmacy to verify that each single unit dose package includes:
•
Name and strength of the drug; Lot and control number equivalent; and,
•
Expiration date.
Determine by inspection whether all medications are stored in a manner that prevents unauthorized access. Review
patient care areas:
Verify that the labels of individual medications conform to State laws.
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Verify that medications prescribed for a patient include:
•
Patient’s full name;
•
Prescriber’s name;
•
Strength and quantity of the drug dispensed; and,
•
Appropriate directions and cautionary statements are included as well as the expiration date.
•
Review and verify that medications provided in floor stock containers include:
•
Name and strength of the drug;
•
Lot and control number equivalent; and
•
Expiration date.
Inspect patient-specific and floor stock medications to identify expired, mislabeled or unusable medications. Review
the hospital policies and procedures governing patient self-administration of drugs and biologicals.
Verify that those administering intravenous medications are working within their scope of practice in accordance with
State law and hospital policy.
Review infusion records to verify the process followed is consistent with the training provided and policies and
procedures are followed.
Discuss the process for addressing adverse drug reactions and the procedure to be followed when this occurs.
MM.2 FORMULARY
SR.1 The medical staff or pharmaceutical oversight group shall select a list of medications to be available
within the organization. The list shall be available to all appropriate staff at all times.
Interpretive Guidelines:
The medical staff or pharmaceutical oversight group shall select a list of medications (formulary) to be available
within the organization. The list shall be available to all appropriate staff at all times.
The formulary lists medications for dispensing or administration that the hospital maintains or that are readily
available. In accordance with accepted standards of practice, the medical staff, in consultation with the pharmacy
service, should develop written criteria for determining what medications are available for dispensing or
administration. At a minimum, the criteria include the indication for use, effectiveness, risks (including propensity for
medication errors, abuse potential, and adverse events), and costs.
The formulary may be maintained either electronically on the hospital’s information management system or in a
hardcopy form. The hospital will ensure a means of notifying the hospital staff and medical staff when changes are
made to the formulary.
The hospital will have a process in place that addresses medication-related issues to include:
•
Communicating with appropriate prescribers and staff;
•
Developing approved substitution protocols;
•
Educating appropriate QLPs, appropriate health care professionals, and staff about these protocols;
and Obtaining medications in the event of a disaster.
The hospital will have a policy and procedure in place to address the process for requests for medications to be
added to the formulary before the medications are available for dispensing and administration and that the medical
staff oversees this process.
The hospital should have processes to approve and procure medications that are not on the hospital’s formulary.
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Surveyor Guidance:
Verify that the pharmacy has an established formulary that of medications that are available in the hospital. Verify
that there is a process for creation and periodic review of a formulary system.
Validate the policy and procedure in place to address the process for requests for medications to be added to the
formulary before the medications are available for dispensing and administration
Verify that the hospital has a process to approve and procure medications that are not on the hospital’s formulary.
MM.3 SCHEDULED DRUGS
SR.1 Current and accurate records must be kept of the receipt and disposition of all scheduled drugs, and
in compliance with all Federal and State documentation requirements.
SR.2 Abuses and losses of controlled substances must be reported, in accordance with applicable Federal
and State laws, to the individual responsible for the pharmaceutical service, and to the chief
executive officer, as appropriate.
Interpretive Guidelines:
The hospital must maintain a record system to maintain current and accurate records of the receipt and disposition
of all scheduled drugs that is in compliance with all Federal and State documentation requirements.
This record system will address the following for all scheduled drugs:
•
Accountability procedures to ensure control of the distribution, use, and disposition;
•
Current and accurate receipt and disposition;
•
Ability to trace the process for moving scheduled drugs throughout the service from the point of entry
into the hospital to the point of departure either through administration to the patient, destruction
or return to the manufacturer;
•
Identity of the pharmacist responsible for determining that all drug records are in order and that an
account of all scheduled drugs is maintained and reconciled;
•
Accounting of all scheduled drugs and any discrepancies in count are reconciled promptly; and,
•
Capability to readily identify loss or diversion of all controlled substances in such a manner as to
minimize the time frame between the actual loss or diversion to the time of detection and
determination of the extent of loss or diversion.
The hospital must develop and implement policies and procedures to minimize abuses and losses of controlled
substances. These procedures must outline, in accordance with applicable Federal and State laws, the reporting
process to the individual responsible for the pharmaceutical service, and to the chief executive officer, as
appropriate.
Surveyor Guidance:
Verify that the record system provides information on scheduled drugs in a readily retrievable manner.
Validate that the records can trace the movement of scheduled drugs throughout the service from the point of entry
into the hospital to the point of departure either through administration to the patient, destruction or return to the
manufacturer.
Verify that this system provides documentation on scheduled drugs in a readily retrievable manner to facilitate
reconciliation of the receipt and disposition of all scheduled drugs.
Verify that the pharmacist is responsible for determining that all drug records are in order and that an account of all
scheduled drugs is maintained and periodically reconciled. Narcotic count sheets and reconciliation sheets could be
sampled when discrepancies are present and the action(s) taken by the hospital to address these discrepancies.
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Validate the hospital system to readily identify loss or diversion of all controlled substances in such a manner as to
minimize the time frame between the actual losses or diversion to the time of detection and determination of the
extent of loss or diversion.
Determine if controlled drug losses are reported to appropriate authorities in accordance with State and Federal
laws.
MM.4 MEDICATION ORDERS
All medication orders shall:
SR.1 Include the name of the drug, the dosage and frequency of administration and the route of
administration.
SR.2 Be in writing and signed, including date and time, by the practitioner or practitioners responsible for
the care of the patient as specified under 42 CFR§482.12(c) and authorized to write such orders by
hospital policy and in accordance with State law.
SR.2a With the exception of influenza and pneumococcal vaccines, which may be administered per
physician- approved hospital policy after an assessment of contraindications, orders for
drugs and biologicals must be documented and signed by a practitioner who is authorized to
write orders in accordance with State law and hospital policy, and who is responsible for the
care of the patient.
SR.3 Telephone or verbal orders are to be used infrequently and when used must be accepted only by
personnel authorized by the medical staff and in accordance with Federal and State law.
SR.4 Verbal orders must be signed or initialed by the prescribing practitioner must be authenticated in
accordance with Federal and State law. If there is not State law that designates a specific timeframe
for the authentication of verbal orders, the orders must be authenticated within a time specified by
hospital policy.
SR.5 Orders for drugs and biologicals may be documented and signed by other practitioners not specified
under 42 CFR§482.12(c) only if such practitioners are acting in accordance with State law, including
scope-of practice laws, hospital policies, and medical staff bylaws, rules, and regulations
Interpretive Guidelines:
Elements to be included in any medication order (including all written, and verbal/telephone orders) include:
•
Name of patient;
•
Age and weight of patient, or other dose calculation requirements, when appropriate;
•
Date and time of the order;
•
Drug name;
•
Dosage form (e.g., tablets, capsules, inhalants);
•
Exact strength or concentration;
•
Dose, frequency, and route;
•
Quantity and/or duration; when applicable
•
Indication for use when appropriate (including orders for PRN administration and/or multiple uses of
medication);
•
Specific instructions for use (i.e. more than one medication for same use such as a pain, nausea);
•
Name of prescriber.
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Hospitals should establish policies and procedures that:
•
Describe limitations or prohibitions on use of verbal/telephone orders;
•
Provide a mechanism to ensure validity/authenticity of the prescriber;
•
List the elements required for inclusion in a complete verbal/telephone order;
•
Describe situations in when verbal/telephone orders may be used;
•
List and define the individuals who may send and receive verbal/telephone orders; and,
•
Provide guidelines for clear and effective communication of verbal/telephone orders.
If a hospital uses other written protocols or standing orders for drugs or biologicals that have been reviewed and
approved by the medical staff, initiation of such protocols or standing orders requires an order from a practitioner
responsible for the patient’s care.
The entire verbal/telephone order should be written down and then repeated back to the prescriber and be signed by
the individual receiving the order. Verbal orders must be documented in the patient’s medical record, and be
reviewed, countersigned, and timed by the prescriber as soon as possible.
Verbal/Telephone orders, when used, should be used infrequently. The hospital will work to continually reduce
verbal/telephone orders.
Surveyor Guidance:
In a sampling of patient records, validate that all drug orders, including verbal orders, contain the elements as
described in the Interpretive Guidelines for MM.4 and are written in the patient charts and signed by the practitioner
caring for the patient.
In a sampling of patient records, verify that the prescriber has reviewed and authenticated the orders in accordance
with medical staff policy and/or applicable State laws.
Verify the process for authentication of verbal orders to ensure these are within the timeframes as stated according
to Federal or State law. If there is not a State law in place, verify that these orders are authenticated within the
timeframe in accordance with hospital policy.
Verify the process for handling of verbal orders and that measures are in place to effectively reduce verbal orders
when possible.
MM.5 REVIEW OF MEDICATION ORDERS
A licensed pharmacist must review all medication orders prior to administration of the first dose to a patient. If a
licensed pharmacist is not available at the time of a first dose administration, the following shall occur:
SR.1 The practitioner caring for the patient must determine the urgency of administration.
SR.2 When a pharmacist is not available medications shall be retrieved from the pharmacy or medication
storage area (including automated dispensing) only by licensed staff designated by the pharmacy
service and approved by the medical staff, in accordance with principles of patient safety and Federal
and State law.
SR.3 The licensed individual that obtains the medication shall have an orientation to the storage area for
the medication.
SR.4 All high-risk medications in the pharmacy or medication storage area shall be segregated and
unavailable.
SR.5 There shall be a documented protocol requiring that this licensed individual have access to
appropriate information to process the order in a formal manner. Information shall include:
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SR.5a potential drug-drug interactions;
SR.5b potential allergies or cross sensitivities;
SR.5c proper dose ranges;
SR.5d proper indications for administration; and,
SR.5e Other contraindications (pregnancy, breast feeding etc.).
SR.6 The licensed individual shall follow the pharmacy protocol for identification of the drug removed for
verification of the drug by the pharmacist upon next arrival at the facility.
SR.7 The removal of the medication must be documented, tracked, and trended and the results analyzed
to determine need for additional pharmacy staff or medication storage resources and
appropriateness of any pharmacy after-hour practices, as appropriate.
Interpretive Guidelines:
All medication orders (except in emergency situations) should be reviewed for appropriateness by a pharmacist or
doctor of medicine or osteopathy before the first dose is dispensed.
Review of medication orders should include:
•
Therapeutic appropriateness of a patient’s medication regimen;
•
Therapeutic duplication in the patient’s medication regimen;
•
Appropriateness of the drug, dose, frequency, route and method of administration;
•
Real or potential medication-medication, medication-food, medication-laboratory test and medication-
disease interactions;
•
Real or potential allergies or sensitivities;
•
Variation from organizational criteria for use; and,
•
Other contraindications (pregnancy, breast feeding etc.)
Note: Routine after-hours access to the pharmacy by non-pharmacists for access to medication should be minimized
and eliminated as much as possible. The use of well-designed night cabinets, after-hours medication carts, and
other methods may preclude the need for non-pharmacist to enter the pharmacy. Policies and procedures should be
consistent with Federal and State law.
When a pharmacist or doctor of medicine or osteopathy is not available and the pharmacy is closed, the hospital will
define the process by a policy and procedure to ensure that following shall occur:
•
The practitioner caring for the patient must determine the urgency of administration;
•
The medications shall be retrieved from the pharmacy or medication storage area only by licensed
staff designated by the pharmacy service and approved by the medical staff, in accordance with
principles of patient safety and Federal and State law; and,
•
The licensed individual that obtains the medication shall have an orientation to the medication storage
area.
The hospital arranges for a qualified pharmacist to be available either on-call or at another location (e.g., at another
organization that has 24-hour pharmacist availability) to answer questions or provide medications beyond those
accessible to non-pharmacy staff;
Quality control procedures (such as an independent second check by another individual or a secondary verification
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built into the system, such as bar coding) are in place to prevent medication retrieval errors.
Medications can be stored in a night cabinet, automated storage and distribution device, or a limited section of the
pharmacy;
All high-risk medications in a medication storage area shall be segregated and unavailable;
There shall be a documented protocol requiring that the licensed individual retrieving medication in the absence of a
pharmacist have access to appropriate information to process the medication order in a formal manner. Information
shall include:
•
Potential drug-drug interactions;
•
Potential allergies or cross sensitivities;
•
Proper dose ranges, and,
•
Proper indications for administration.
The licensed individual retrieving the medication shall follow the pharmacy protocol for identification of the drug
removed for verification by the pharmacist upon next arrival at the facility.
The removal of the medication must be documented, tracked and trended and the results analyzed to determine
need for additional pharmacy staff or medication storage resources and appropriateness of any pharmacy after-hour
practices.
This process is continually evaluated to determine the medications accessed routinely and the causes of accessing
the pharmacy after hours.
Corrective/Preventive action(s) are implemented as appropriate to reduce the amount of times non-pharmacist
health care professionals are obtaining medications after the pharmacy is closed.
The effects of medication(s) on patients are monitored to assure medication therapy is appropriate and minimizes
the occurrence of adverse events. That monitoring process includes:
•
Clinical and laboratory data to evaluate the efficacy of medication therapy to anticipate or evaluate
toxicity and adverse effects;
•
Physical signs and clinical symptoms relevant to the patient’s medication therapy; and,
•
Assessing the patient’s own perceptions about side effects, and, when appropriate, perceived efficacy.
Sterile products should be prepared and labeled in a suitable environment.
Surveyor Guidance:
Verify through a sampling of pharmacy records that documents the process when the pharmacist is not available,
drugs are removed from the pharmacy (drug storage area) only by a designated individual (in accordance with State
law, if applicable) and only in amounts sufficient for immediate therapeutic needs.
Validate policies and procedures to determine who is designated to remove medications from the pharmacy or
storage area and the amount a non-pharmacist may remove in the absence of a pharmacist. The individual(s)
designated should be identified by name and have the appropriate qualifications.
Validate the system in place to ensure accurate documentation regarding the removal of medications (type and
quantity) from pharmacy or the location where medications are stored after the pharmacy has closed.
Verify that a pharmacist or doctor of medicine or osteopathy reviews all medication removal activity and correlates
the removal with current medication orders in the patient medication profile.
Review and validate that the pharmacy routinely reviews the contents of the after-hours supply to determine if it is
adequate to meet the after-hours needs of the hospital and implements appropriate corrective/preventive action to
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minimize entry into the pharmacy after the pharmacy has closed.
MM.6 OVERSIGHT GROUP
SR.1 The medical staff is responsible for developing policies and procedures that minimize drug errors.
The medical staff may delegate this responsibility to an organized pharmacy oversight group.
SR.2 There shall be procedures for reporting transfusion reactions, adverse drug reactions, and errors in
prescribing, preparing, and administering of drugs, in the aggregate, for trending and analysis.
SR.3 Drug preparation, administration, and prescribing errors, adverse drug reactions, and
incompatibilities must be immediately reported to the attending physician and to the organization-
wide quality management program.
Interpretive Guidelines:
Policies and procedures shall be developed with the involvement and approval of the medical staff in order to
minimize medication errors, adverse drug reactions, and drug incompatibility.
The hospital will develop and implement procedures for reporting transfusion reactions, adverse drug reactions, and
errors in prescribing, preparing, and administration of medications. These errors and reactions must be immediately
reported to the patient’s attending physician, or when appropriate the covering physician. When the covering
physician is notified due to the attending physician not being available, the patient’s attending physician must be
notified as soon as he/she is available.
The hospital will document the information obtained from the errors and reactions reported and have a means for
aggregating this information and related data to be trended and analyzed and continually evaluated in order to
identify and implement corrective/preventive action.
The facility must have a method to measure the effectiveness of its reporting system to determine whether or not
their system(s) is identifying as many medication errors and adverse drug reactions that would be expected for the
size and scope of services provided by their hospital. Such methods could include use of established benchmarks or
studies on reporting rates published in peer-reviewed journals.
To improve incident reporting, the facility should adopt a non-punitive system with the focus on the system and not
the involved health care professionals.
Surveyor Guidance:
Verify that policies and procedures are developed in order to minimize medication errors, adverse drug reactions,
and drug incompatibilities.
These policies and procedures must include the involvement and approval of the medical staff.
Validate that the hospital has an effective procedure that ensures drug administration errors, adverse drug reactions,
and drug incompatibilities are immediately reported to the attending physician.
In a sampling of records, review medication errors and adverse drug reactions to determine that they are reported
immediately in accordance with written procedures, and that medications administered and/or drug reactions are
promptly recorded in the patient’s medical record.
Determine if the hospital’s definition of an adverse drug reaction and medication error is based on established
benchmarks or studies on report rate published in peer review journals and/or from other sources (i.e. ISMP).
To determine the effectiveness of the internal reporting mechanism, assess whether or not the identification of
medication errors are as expected for the size and scope of services provided by the hospital. If the perception is
such that medication errors are considered under-reported, determine the action(s) the hospital is taking to ensure
accurate reporting of such errors. Also, assess staff awareness of the internal reporting process when medication
errors and adverse drug reactions are identified.
Verify the effectiveness of the reporting mechanism and the ability to retrieve data/information to be trended,
analyzed, and evaluated in order to implement and determine the effectiveness of corrective/preventive action(s).
Verify such information is forwarded to quality management oversight.
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Assess through interviews with facility staff (nursing, pharmacy, and medicine) awareness of the facility’s policy on
reporting and documentation of medication errors and adverse drug reactions.
MM.7 AVAILABLE INFORMATION
SR.1 Information relating to drug interactions and information on drug therapy, side effects, toxicology,
dosage, indications for use, and routes of administration shall be available to the professional staff.
Surveyor Guidance:
Verify that the sources of drug information (including information relating to drug interactions and information on
drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration) are available to all
professional staff.
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SURGICAL SERVICES (SS)
SS.1 ORGANIZATION
SR.1 If the organization provides surgical services, the services shall be well organized, appropriate to the
scope of the services offered, and provided in accordance with acceptable standards of practice.
National standards of practice of AORN, CDC, APIC, ASA, AANA and other professional organizations
are applicable to surgical services.
SR.2 If outpatient surgical services are offered, the services must be consistent in quality with inpatient
care in accordance with the complexity of services offered.
SR.3 Surgical care must be designed to assure the achievement and maintenance of high standards of
medical practice and patient care, and must be consistent with needs and resources.
SR.4 The organization must develop and implement policies and procedures for providing surgical services
that are in accordance with acceptable standards of medical practice and surgical patient care.
Policies and procedures shall include at least the following:
SR.4a Aseptic surveillance and practice, including scrub techniques;
SR.4b Identification of infected and non-infected cases;
SR.4c Housekeeping requirements/procedures;
SR.4d Customer satisfaction feedback;
SR.4e Duties of scrub and circulating nurse. Duties may be defined within a job description, but
may vary depending on the cases for which these staff members are involved;
SR.4f Conducting surgical counts in accordance with accepted standards of practice. The hospital
will have a process in place to ensure that no foreign bodies are retained in patients
following surgical procedures;
SR.4g The scheduling of patients for surgery;
SR.4h Patient care requirements including:
SR.4h(i) Pre-operative testing,
SR.4h(ii) Clinical procedures
SR.4h(iii) Patient identification procedure and site verification process
SR.4i Resuscitative techniques;
SR.4j How the DNR status is addressed when indicated in the patient’s records;
SR.4k Handling, care and labeling of surgical specimens;
SR.4l Procedure-specific or in general protocols that are appropriate for all surgical procedures
performed. This will include a list of equipment, materials, and supplies necessary to
properly carry out the surgical services provided;
SR.4m Sterilization and disinfection procedures;
SR.4n Handling infectious and biomedical/medical waste;
SR.4o Monitoring of temperature and humidity;
SR.4p Safety practices (e.g., fire safety, site marking, time-outs, etc.); and,
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SR.4q Acceptable operating room attire.
Interpretive Guidelines:
If the hospital provides any surgical services, they must be organized and staffed in such a manner to ensure the
health and safety of patients and be in accordance with acceptable standards of practice. These standards of
practice include the American College of Surgeons, Association of Operating Room Nurses (AORN), Centers for
Disease Control (CDC), Association for Professionals in Infection Control and Epidemiology (APIC), American Society
of Anesthesiologists (ASA), American Association of Nurse Anesthetists (AANA), and other professional organizations
that are applicable to the scope and complexity of surgical services provided.
A surgery includes any procedure that is listed in any of the various coding systems used by CMS or hospital,
regardless of reimbursement for the surgical procedure.
If the hospital provides outpatient surgical services, they must be in compliance with all hospital standards including
the surgical services standards. These outpatient surgical services must be provided in accordance with acceptable
standards of practice and in accordance with the complexity of services offered.
The hospital must design the surgical services to assure the standards of medical practice and patient care are
implemented and maintained.
The hospital must develop and implement policies and procedures for providing surgical services that are in
accordance with acceptable standards of medical practice and surgical patient care.
These policies and procedures shall include, at least the following:
•
Aseptic and sterile surveillance and practice, including scrub techniques;
•
Identification of infected and non-infected cases;
•
Housekeeping requirements/procedures;
•
Duties of scrub and circulating nurse. These may be defined within a job descriptions, but may vary
depending on the cases for which these staff members are involved;
•
Conducting surgical counts in accordance with accepted standards of practice.
•
The hospital will have a process in place to ensure that no foreign bodies are retained in patients
following surgical procedures;
•
The scheduling of patients for surgery;
•
Patient care requirements:
•
Pre-operative testing
•
Clinical procedures
•
Patient identification procedure and site verification process
•
Resuscitative techniques;
•
How the DNR status is addressed when indicated in the patient’s records;
•
Handling, care and labeling procedures of surgical specimens;
•
Malignant hyperthermia;
•
Procedure-specific or in general protocols that are appropriate for all surgical procedures performed.
This will include a list of equipment, materials, and supplies necessary to properly carry out the
surgical services provided;
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•
Sterilization and disinfection procedures;
•
Handling infectious and biomedical waste;
•
Monitoring of temperature and humidity;
•
Safety practices (fire safety, site marking, time-outs, etc.); and,
•
Acceptable operating room attire.
Surveyor Guidance:
Review and verify the extent of surgical services provided by the hospital and verify that services are in accordance
with acceptable standards of practice. In order to do this appropriately, request the use of proper attire (gown, cap,
and other attire as required by the hospital) to be worn during a physical tour during this review.
Review and validate policies and procedures to determine that minimum elements are addressed as specified in the
Interpretive Guidelines for SS.1.
Malignant hyperthermia rescue capability should be thoroughly assessed in those hospitals that perform a significant
number of surgical procedures under general anesthesia.
Verify that access to the operative and recovery area is limited to authorized personnel and that the traffic flow
pattern adheres to accepted standards of practice.
Verify that operating room attire is suitable for the kind of surgical case performed, that persons working in the
operating suite must wear only clean surgical costumes, and that surgical costumes are designed for maximum skin
and hair coverage.
Verify that the hospital has equipment available for rapid and routine sterilization of operating room materials and
that the equipment used for this purpose is monitored, inspected, tested, and maintained by the hospital’s
biomedical equipment/clinical engineering program.
Verify that there is a process in place for handling sterilized materials and that these materials are packaged,
labeled, and stored in a manner that ensures sterility (e.g., in a moisture and dust controlled environment and
policies and procedures for expiration dates have been developed and are followed in accordance with accepted
standards of practice.)
SS.2 STAFFING AND SUPERVISION
SR.1 The organization of the surgical services shall be supervised by either a registered nurse with
appropriate experience, or by a doctor of medicine or osteopathy.
SR.2 Under the supervision of a registered nurse, the following personnel may serve as “scrub nurses”:
SR.2a Registered nurses;
SR.2b LPNs/LVNs; and,
SR.2c Surgical technologists (operating room technicians).
SR.3 Qualified registered nurses shall perform circulating duties in the operating room. If a qualified
registered nurse is present who is immediately available to respond to emergencies, licensed
practical nurses and surgical technologists may assist in circulatory duties under the supervision of
that registered nurse, if State law and medical staff policies and procedures permit.
Interpretive Guidelines:
The hospital surgical services (including both inpatient and outpatient) must be supervised by an experienced RN or
MD/DO. The RN or MD/DO supervising the operating room must possess appropriate education, experience working
in surgical services, and specialized training in the provision of surgical services/management.
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The hospital must provide the appropriate equipment and the types and numbers of qualified personnel necessary to
furnish the surgical services offered by the hospital in accordance with acceptable standards of practice.
Qualified registered nurses must perform circulating duties in the operating room. If a qualified registered nurse is
present in the operating suite who is immediately available to respond to emergencies, LPNs/LVNS, and surgical
technologists (ST) may assist in circulatory duties under the supervision of the registered nurse, if allowed by State
law and medical staff policies and procedures.
Surveyor Guidance:
Review the hospital’s organizational chart regarding surgical services to confirm that there are lines of authority and
delegation of responsibility indicated within surgical services.
Verify that an RN or a doctor of medicine or osteopathy is assigned responsibility for supervision of surgical services.
Request a copy of the supervisor’s position description to determine that it specifies qualifications, duties, and
responsibilities of the position.
Determine and validate that an RN is available for supervision in the department or service.
Review and verify that the hospital maintains appropriate staffing schedules to provide adequate staff and RN
supervision.
Verify in situations where LPNs and STs are permitted to assist with circulating duties that a qualified RN supervisor
is immediately available to respond to emergencies.
SS.3 PRACTITIONER PRIVILEGES
SR.1 All practitioners performing surgery shall have surgical privileges established by the organization’s
department of surgery and medical staff and approved by the governing body. Surgical privileges
shall correspond with the established competencies of each practitioner.
SR.2 A current roster of practitioners and their privileges shall be maintained by the department of
surgery.
SR.3 Privileges for general surgery and surgical subspecialties defined with established criteria approved
by the medical staff and in accordance with MS.12.
Interpretive Guidelines:
All practitioners performing surgery shall have surgical privileges established by the organization’s department of
surgery and medical staff and approved by the governing body.
The medical staff bylaws must include criteria for determining the privileges to be granted to an individual
practitioner and a procedure for applying the criteria to individuals requesting privileges. Core privileges for general
surgery and surgical subspecialties are acceptable as long as the core is properly defined.
Surgical privileges shall correspond with the established competencies of each practitioner. Surgical privileges should
be reviewed and updated at least every 2 years as per IG at 42 CFR Section 482.51(a)(4).
A current roster listing each practitioner’s specific surgical privileges must be available in the surgical suite and
area/location where the scheduling of surgical procedures is completed. The hospital will also be able to identify the
surgeons with suspended surgical privileges or whose surgical privileges have been restricted and this information
must also be retained in these areas/locations.
Surveyor Guidance:
Validate the hospital’s method for reviewing practitioners’ surgical privileges. This method should require verification
of practitioner training, experience, health status, and performance.
Confirm that the hospital provides a current roster listing each practitioner’s specific surgical privileges and that the
roster is available in the surgical suite and the area where the scheduling of surgical procedures is done.
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Verify that a current list of surgeons suspended from surgical privileges or who have restricted surgical privileges is
retained in these areas/locations.
SS.4 HISTORY AND PHYSICAL
SR.1 Except in emergencies, there must be a complete H&P in the medical record of every patient prior to
surgery or procedure requiring anesthesia services.
SR.1a A complete H&P examination must be completed and documented no more than 30 days
before or 24 hours after admission or registration.
SR.1b When the history and physical is completed within 30 days prior to admission or
registration, an updated medical record entry documenting an examination for any changes
in the patient’s condition must be completed and documented in the patient’s medical
record within 24 hours after admission or registration, and prior to surgery or procedure
requiring anesthesia services.
SR.2 An MD/DO shall perform the H&P examination. Alternatively, a PA or advance practice nurse may
perform an H&P if permitted by State law and scope of practice. The responsible physician must
review and approve the H&P in accordance with the policy of the hospital and State law.
SR.3 The content of the H&P examination and applicability shall be determined in accordance with the
policy of the hospital and may be done by the individuals described in SS.4, SR.2. The content of the
H&P examination will be determined by an assessment of the patient’s condition and any co-
morbidities in relation to the reason for surgery. The H&P must be in the medical record prior to
surgery.
SR.4 If the history and physical has been dictated but not yet present in the patient’s medical record, the
practitioner who admitted the patient shall write a statement to that effect as well as an admission
note in the medical record. Such circumstance is acceptable only in a medical emergency and is not
applicable for a scheduled surgery.
SR.5 A properly executed informed consent form for the surgery shall be in the patient’s medical record
before surgery except in an extreme medical emergency. A properly executed informed consent form
contains at least the following:
SR.5a Name of patient, and when appropriate, patient’s authorized representative;
SR.5b Name of hospital;
SR.5c Description of the proposed surgical procedure(s), including anesthesia to be used;
SR.5d Name of practitioner(s) performing the procedure(s) or important aspects of the
procedure(s), as well as the name(s) and specific significant surgical tasks that will be
conducted by practitioners other than the primary surgeon/practitioner. (Significant surgical
tasks include: opening and closing, harvesting grafts, dissecting tissue, removing tissue,
implanting devices, altering tissues.);
SR.5e Signature of patient or his/her authorized representative;
SR.5f Date and time consent is obtained;
SR.5g Statement that procedure(s) was explained to patient or legal guardian;
SR.5h Signature of professional person witnessing the consent; and,
SR.5i Name/signature of person who explained the procedure to the patient or guardian.
Interpretive Guidelines:
There must be a complete H&P in the medical record of every patient prior to surgery, except in emergencies.
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When an H&P has been conducted, but is not present on the chart prior to surgery, or in emergency situations where
a complete H&P cannot be conducted prior to surgery, the practitioner who admitted the patient shall write a
statement to that effect as well as an admission note in the medical record. The note should include, at a minimum,
critical information about the patient’s condition including pulmonary status, cardiovascular status, blood pressure,
and vital signs.
The medical record must contain an H&P (as required for all inpatient and appropriate outpatient settings) and must
be performed no more than 30 days prior to admission or registration or within 24 hours after admission by an
authorized practitioner.
The H & P must be placed in the patient’s medical record within 24 hours of admission. In the event that the H & P
is completed prior to admission; the hospital must ensure that this H & P is updated to document any changes in the
patient’s condition.
The hospital will ensure that a properly executed informed written consent form for the surgical procedure(s) to be
performed is signed by the patient or his/ her authorized representative prior to the surgical procedure. The only
exception is an extreme emergency.
An informed consent discussion with the patient should include at least the following: description of the proposed
surgery, including anesthesia to be used, an explanation of the nature and purpose of the proposed procedures;
risks and consequences of the procedures; risks and prognosis if no treatment is rendered, the probability that the
proposed procedure will be successful; and, alternative methods of treatment (if any) and their associated risks and
benefits. Furthermore, informed consent would include that the patient is informed as to who will actually perform
the surgical procedure(s). When practitioners other than the primary surgeon will perform important components of
the surgical procedure(s) the patient must be informed of the identity of these other practitioners and the
components these practitioners are expected to perform. The identity of these other practitioners must be disclosed
even when these practitioners are working under the primary surgeon’s supervision.
The hospital’s surgical informed consent policy should describe the following:
•
Who may obtain the patient’s informed consent
•
Which procedures require informed consent
•
The circumstances under which surgery is considered an emergency and may be undertaken without
an informed consent
•
The circumstances when a patient’s representative, rather than the patient, may give informed
consent for surgery
•
The content of the informed consent form and instructions for completion
•
The process used to obtain informed consent, including how the informed consent is to be
documented in the medical record
•
Mechanisms that ensure that the informed consent form is properly executed and is in the medical
record prior to surgery (except in the case of an emergency)
•
If the informed consent process and informed consent form are obtained outside the hospital, how the
properly executed informed consent form is incorporated into the patient’s medical record prior to
surgery
For surgeries in which residents will perform important parts of the surgery, discussion is encouraged with the
patient or their representative to include the following:
•
That it is anticipated that physicians who are in approved post graduate residency training programs
will perform portions of the surgery, based upon their availability and level of competence.
•
That it will be decided at the time of the surgery which residents will participate and their manner of
participation, and that this will depend on the availability of the residents with the necessary
competence; knowledge that the operating practitioner/teaching surgeon has of the resident’s skill
set; and the patient’s condition.
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•
That residents performing surgical tasks will be under the supervision of the operating
practitioner/teaching surgeon.
•
Whether, based on the resident’s level of competence, the operating practitioner/teaching surgeon will
not be physically present in the same operating room for some or all of the surgical tasks
performed by residents.
Surveyor Guidance:
In a sampling of medical records of surgical patients, determine if a complete history and physical examination by a
doctor of medicine or osteopathy or qualified licensed practitioner is completed prior to surgery, except in an
emergency, and in accordance with the methodology described above.
Verify that the completion of an H&P was within the specified time frame and appropriate documentation noted.
Verify the content and completeness of the H&P per organization policy:
•
In some cases the organization may accept an H&P that has been completed in the practitioner’s
office. When this is allowed, verify the process for ensuring that the appropriate documentation is
present and completed per the requirements of the organization and the H&P was completed within
the required timeframe.
Verify that an H&P was completed no more than 30 days before or 24 hours after admission or registration and in all
cases involving surgery or procedures requiring anesthesia services prior to the surgery or procedure.
Verify that documentation of an H&P was placed in the medical record within 24 hours after admission or
registration, and in all cases involving surgery or procedures requiring anesthesia services prior to the surgery or
procedure.
Where an H&P is completed within 30 days before admission or registration and in all cases involving surgery or
procedures requiring anesthesia services or moderate/conscious sedation, the organization must ensure that this
H&P is updated to document any changes in the patient’s condition (See MS. 17, SR.1).
•
If there are no changes to the H&P as written, the physician or qualified licensed practitioner can
simply document an update note stating that:
•
The H&P has been reviewed,
•
The patient has been examined, and,
•
The physician or qualified licensed practitioner concurs with the findings of the H&P completed on the
specified date or that ‘‘no change’’ has occurred in the patient’s condition since the H&P was
completed.
In a sampling of medical records of surgical patients, verify that informed written consent forms are present, have
been properly executed, and are present in the patient’s medical record prior to surgery.
Ascertain that the completed forms contain at least the information specified in SS.4, SR.5 and the Interpretive
Guidelines.
Verify that the hospital’s informed consent policies address the circumstances when a surgery would be considered
an emergency and thus not require an informed consent form be placed in the medical record prior to surgery.
SS.5 AVAILABLE EQUIPMENT
The following equipment shall be present and in operating condition and immediately available to each surgical suite:
SR.1 Call-in system;
SR.2 Cardiac monitor;
SR.3 Resuscitator;
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SR.4 Defibrillator;
SR.5 Suction equipment;
SR.6 Provisions for emergency airway intervention; and,
SR.7 Malignant Hyperthermia (MH) rescue materials:
SR.7a Dantrolene sufficient to treat an MH episode must be available for all anesthetizing locations
within 10 minutes of the decision to treat for MH;
SR.7b Dantrolene must be available for all anesthetizing locations where MH trigger agents are
used; and,
SR.7c Required components to safely administer Dantrolene must be readily accessible.
Interpretive Guidelines:
All facilities, including ambulatory surgery centers and offices, where MH triggering anesthetics (isoflurane,
desflurane, sevoflurane, enflurane, halothane and succinylcholine) are administered, should stock the minimum
amount of dantrolene necessary to treat an MH episode along with the other drugs and devices necessary to treat an
MH episode. If none of these agents are ever in use in the facility, then dantrolene need not be kept at hand.
Two formulations of dantrolene are available. Per the recommendations of the Malignant Hyperthermia Association of
the United States (MHAUS):
“To treat an MH episode, an initial dose of dantrolene at 2.5 mg/kg is recommended, with a suggested upper limit of
10 mg/kg. If a patient of average weight (approximately 70 kg) were to require dantrolene at the upper dosing limit,
then at least 700 mg of dantrolene would be needed.
•DANTRIUM
®
/REVONTO
®
– stock a minimum of 36 - 20 mg vials
•RYANODEX
®
– stock a minimum of 3 - 250 mg vials”
Surveyor Guidance:
Review and verify that the hospital has equipment immediately available to each surgical suite to include, at least,
those items as listed in SS.5, SR.1 – SR.7.
Validate that all equipment is working as intended and is maintained, inspected, and tested by the hospital’s
biomedical/clinical engineering department or contracted service.
Verify that a tracheotomy set is available (a cricothyroidotomy set should not be considered a substitute for this set).
SS.6 OPERATING ROOM REGISTER
SR.1 The operating room register shall be complete and current. The operating room register will include
at least the following information:
SR.1a Patient’s name;
SR.1b Patient’s hospital identification number;
SR.1c Date of the operation/procedure;
SR.1d Inclusive or total time of the operation/procedure;
SR.1e Name of the surgeon and any assistant(s);
SR.1f Name of nursing personnel (scrub and circulating);
SR.1g Type of anesthesia used and name of the administering practitioner;
SR.1h Operation/procedure performed;
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SR.1i Pre-and post-operative diagnosis; and,
SR.1j Age of patient.
Interpretive Guidelines:
The operating room register will include at least the following information:
•
Patient’s name;
•
Patient’s hospital identification number;
•
Date of the operation/procedure;
•
Inclusive or total time of the operation/procedure;
•
Name of the surgeon and any assistant(s);
•
Name of nursing personnel (scrub and circulating);
•
Type of anesthesia used and name of the administering practitioner;
•
Operation/procedure performed;
•
Pre and post-op diagnosis; and,
•
Age of patient.
Surveyor Guidance:
Review and validate the OR register or equivalent record to ensure that it lists all surgery performed by the surgical
services and includes the elements as listed in the Interpretive Guidelines for SS.6.
SS.7 POST-OPERATIVE CARE
SR.1 There shall be adequate provision for immediate post-operative care.
SR.2 Equipment, clinical staff, and plan of care provisions as well as criteria for discharge shall be
developed and adopted by the medical staff and nurse executive designees.
Interpretive Guidelines:
The hospital will make adequate provisions for immediate post-operative care. These provisions will include:
•
Post-operative care is provided in accordance with acceptable standards of practice; and,
•
The post-operative care area or recovery room is a separate area of the hospital.
•
Access is limited to authorized personnel.
The hospital will provide the appropriate equipment and clinical staff to adequately address the patients’ plan of care
appropriate to the complexity of services provided. The hospital will develop criteria for the discharge from the
postoperative care area that have been approved by the medical staff and nurse executive.
Prior to discharge, the hospital must ensure that the patient has met the appropriate criteria for discharge and that
the patient has an order for discharge from the patient’s surgeon or practitioner.
If patients are not transferred to the post-operative care area, there must be provisions for direct observation of the
patient by a qualified nurse in the patient’s room to ensure there is a comparable level of care during the recovery
phase.
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Surveyor Guidance:
Review and validate the process and provisions for post-operative care, including discharge criteria.
Review and verify that the hospital provides the appropriate equipment and clinical staff to adequately address the
patient’s plan of care appropriate to the complexity of services provided.
SS.8 OPERATIVE REPORT
SR.1 An operative report describing techniques, findings, and tissues removed or altered shall be dictated
or documented, and authenticated by the surgeon immediately following surgery. The operative
report will contain at least the following:
SR.1a Name and hospital identification number of the patient;
SR.1b Date and times of the surgery;
SR.1c Name(s) of the surgeon(s) and assistants or other practitioners who performed surgical
tasks (even when performing those tasks under supervision);
SR.1d Pre-operative and post-operative diagnosis;
SR.1e Name of the specific surgical procedure(s) performed;
SR.1f Type of anesthesia administered;
SR.1g Complications;
SR.1h A description of techniques, findings, and tissues removed or altered;
SR.1i Estimated blood loss (specify N/A if no blood loss);
SR.1j Surgeons or practitioners name(s) and a description of the specific significant surgical tasks
that were conducted by practitioners other than the primary surgeon/practitioner
(significant surgical tasks include: opening and closing, harvesting grafts, dissecting tissue,
removing tissue, implanting devices, altering tissues); and,
SR.1k Prosthetic devices, grafts, tissues, transplants, or devices implanted (if any).
SR.2 The operative report shall be dictated or documented and authenticated in its entirety before the
patient is transferred to the next level of care (e.g., before the patient leaves the post anesthesia
care area).
SR.3 In the event that an operative report cannot be dictated and placed on the patient’s chart before
transfer to the next level of care, an immediate postoperative/post procedure note is required to be
documented. The note shall include identification or description of:
SR.3a The surgeon and assistants;
SR.3b Pre-operative and post-operative diagnosis;
SR.3c Procedures performed;
SR.3d Specimens removed;
SR.3e Estimated blood loss;
SR.3f Complications (if any encountered);
SR.3g Type of anesthesia administered; and,
SR.3h Grafts or implants (may indicate where in chart for detail).
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SR.4 If information identified in the immediate post-operative/post procedure note is available in nursing
documentation; it is acceptable if authenticated as accurate by the attending surgeon.
Interpretive Guidelines:
The intent of the immediate operative report or postoperative/post-procedure note is to ensure that the next
provider of care has the information necessary to make further appropriate care decisions.
The hospital may, in some circumstances, choose to require a postoperative/post procedure note in other settings or
for specific high-risk procedures when anesthesia services are not required.
For example, at the discretion of the Medical Staff, a hospital may, following a risk based assessment, choose to
require a postoperative/post procedure note for:
• Any procedure requiring moderate sedation outside of the surgical setting (e.g., Endoscopy)
• Other identified high-risk procedures
If such determinations were made, the expectation is that the requirements would be delineated in the Medical Staff
Rules and Regulations and applied accordingly.
A postoperative/post-procedure note would not generally be expected for bedside procedures or in other settings
(e.g., Emergency Department) where a patient would be transferred home.
An operative report must be dictated or documented and authenticated by the surgeon immediately following
surgery and before the patient is transferred to the next level of care. The operative report will contain at least the
following:
•
Name and hospital identification number of the patient;
•
Date and times of the surgery;
•
Name(s) of the surgeon(s) and assistants or other practitioners who performed surgical tasks (even
when performing those tasks under supervision);
•
Pre-operative and post-operative diagnosis;
•
Name of the specific surgical procedure(s) performed;
•
Type of anesthesia administered;
•
Complications;
•
A description of techniques, findings, and tissues removed or altered;
•
Surgeons or practitioners name(s) and a description of the specific significant surgical tasks that were
conducted by practitioners other than the primary surgeon/practitioner (significant surgical
procedures include: opening and closing, harvesting grafts, dissecting tissue, removing tissue,
implanting devices, altering tissues); and,
•
Prosthetic devices, grafts, tissues, transplants, or devices implanted.
If information identified in the immediate post-operative/post procedure note is available elsewhere in the medical
record; it is acceptable if referred to and authenticated as accurate by the attending surgeon.
Surveyor Guidance:
In a sampling of surgical patients’ medical records, validate that the records contain an operative report that
includes the information specified in the Interpretive Guidelines for SS.8.
In a sampling of medical records of surgical patients and a delay in dictation has been identified, validate that the
medical record contains an immediate postoperative note that includes the information specified in SR.1a – SR.1h
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(above).
In the event that there is no delay in dictation during the time the surveyor is on-site, validate that the hospital has
a process in place for the immediate postoperative note to be written and that this is enforced by the hospital.
With the advent of the electronic medical record (EMR), instances might exist where a surgeon’s operative report or
immediate postoperative/post procedure note is completed prior to the close of the surgical case rather than
immediately following surgery (e.g., multidisciplinary operations that require the involvement of two or more
surgeons of different specialties; overlapping surgeries where the surgeon proceeds to a subsequent surgical
procedure once the critical portions of the first procedure are completed). In such cases, it is acceptable if the
operative report is dated and timed prior to the end of the surgical procedure.
https://www.facs.org/about-acs/statements/stonprin
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ANESTHESIA SERVICES (AS)
AS.1 ORGANIZATION
SR.1 Anesthesia services shall be provided in an organized manner, and function under the direction of a
qualified doctor of medicine or osteopathy. The anesthesia service is responsible for all anesthesia
services provided throughout the hospital (including all departments in all campuses and off site
locations).
SR.2 Anesthesia services shall be appropriate to the scope of the services offered.
Interpretive Guidelines:
The hospital may or may not offer anesthesia/sedation services. If a hospital does provide any degree of
anesthesia/sedation service to its patients, these services will be provided in an organized manner. The
anesthesia/sedation services will be offered under the direction of a qualified doctor or medicine or osteopathy. This
individual will be responsible for all anesthesia/sedation administered throughout the hospital.
“Anesthesia” involves the administration of a medication to produce a blunting or loss of:
• Pain perception (analgesia);
• Voluntary and involuntary movements;
• Autonomic function; and,
• Memory and/or consciousness, depending on where along the central neuraxial (brain and spinal cord)
the medication is delivered.
In contrast, “analgesia” involves the use of a medication to provide relief of pain through the blocking of pain
receptors in the peripheral and/or central nervous system. The patient does not lose consciousness, but does not
perceive pain to the extent that may otherwise prevail.
“Anesthesia services” in a hospital is subject to the anesthesia administration requirements.
The additional definitions below illustrate differences among the various types of anesthesia services. Not all of the
definitions are considered “anesthesia.” The definitions are generally based on American Society of Anesthesiologists
definitions found in its most recent set of practice guidelines.
•
General anesthesia: a drug-induced loss of consciousness during which patients are not arousable,
even by painful stimulation. The ability to independently maintain ventilatory support is often
impaired. Patients often require assistance in maintaining a patent airway, and positive pressure
ventilation may be required because of depressed spontaneous ventilation or drug-induced
depression of neuromuscular function. Cardiovascular function may be impaired. For example, a
patient undergoing major abdominal surgery involving the removal of a portion or all of an organ
would require general anesthesia in order to tolerate such an extensive surgical procedure. General
anesthesia is used for those procedures when loss of consciousness is required for the safe and
effective delivery of surgical services;
•
Regional anesthesia: the delivery of anesthetic medication at a specific level of the spinal cord and/or
to peripheral nerves, including epidurals and spinals and other central neuraxial nerve blocks, is
used when loss of consciousness is not desired but sufficient analgesia and loss of voluntary and
involuntary movement is required. Given the potential for the conversion and extension of regional
to general anesthesia in certain procedures, it is necessary that the administration of regional and
general anesthesia be delivered or supervised by the qualified practitioner.
The administration of medication via an epidural or spinal route for the purpose of analgesia, during labor and
delivery, is not considered anesthesia and therefore is not subject to the anesthesia supervision requirements.
However, if the obstetrician or other qualified physician attending to the patient determines that an operative
delivery (i.e., C-section) of the infant is necessary, it is likely that the subsequent administration of medication is for
anesthesia, as defined above, and the anesthesia supervision requirements would apply.
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•
Monitored anesthesia care (MAC): anesthesia care that includes the monitoring of the patient by a
practitioner who is qualified to administer anesthesia. Indications for MAC depend on the nature of
the procedure, the patient’s clinical condition, and/or the potential need to convert to a general or
regional anesthetic. Deep sedation/analgesia is included in MAC.
•
Deep sedation/analgesia: a drug-induced depression of consciousness during which patients cannot be
easily aroused but respond purposefully following repeated or painful stimulation. The ability to
independently maintain ventilatory function may be impaired. Patients may require assistance in
maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular
function is usually maintained. An example of deep sedation would be a screening colonoscopy
when there is a decision to use Propofol, so as to decrease movement and improve visualization for
this type of invasive procedure. Because of the potential for the inadvertent progression to general
anesthesia in certain procedures, it is necessary that the administration of deep sedation/analgesia
be delivered or supervised by a qualified practitioner as specified.
“Anesthesia services” in a hospital NOT subject to the anesthesia administration and supervision requirements:
•
Topical or local anesthesia;
•
Minimal sedation: A drug-induced state during which patients respond normally to verbal commands.
Although cognitive function and coordination may be impaired, ventilator and cardiovascular
functions are unaffected. For example, a patient undergoing an MRI or CT scan may receive
minimal sedation with an oral medication to decrease the anxiety while undergoing these types of
radiologic examinations;
•
Moderate sedation/analgesia: (“Conscious Sedation”): A drug-induced depression of consciousness
during which patients respond purposefully to verbal commands, either alone or accompanied by
light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous
ventilation is adequate. Cardiovascular function is usually maintained. For example, a patient
undergoing the reduction of a dislocated large joint (shoulder) may require this form of sedation to
tolerate the procedure.
Rescue Capacity: Because sedation is a continuum, it is not always possible to predict how an individual patient will
respond. Hence, the hospital must ensure that procedures are in place to rescue patients whose level of sedation
becomes deeper than initially intended, for example, patients who inadvertently enter a state of Deep
Sedation/Analgesia when moderate sedation was intended. “Rescue” from a deeper level of sedation than intended
requires an intervention by a practitioner with expertise in airway management and advanced life support (ACLS,
ATLS, PALS, etc.) The qualified practitioner corrects adverse physiologic consequences of the deeper-than-intended
level of sedation and returns the patient to the originally intended level of sedation.
Anesthesia services throughout the hospital (including all departments in all campuses and off-site locations where
anesthesia services are provided) must be organized into one anesthesia service, under the direction of a qualified
MD/DO. Areas where anesthesia services are furnished may include (but are not limited to):
•
Operating room suite(s), both inpatient and outpatient;
•
Obstetrical suite(s);
•
Radiology department;
•
Clinics;
•
Emergency department;
•
Psychiatry department;
•
Outpatient surgery areas; and
•
Special procedures areas (e.g., endoscopy suite, pain management clinic, etc.).
The hospital’s medical staff establishes criteria for the qualifications for the director of the anesthesia services in
accordance with State laws and acceptable standards of practice. The anesthesia service is responsible for
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developing policies and procedures governing the provision of all categories of anesthesia services, including
specifying the minimum qualifications for each category of practitioner who is permitted to provide anesthesia
services that are not subject to the anesthesia administration requirements.
A well-organized anesthesia service must be integrated into the hospital’s QMS, in order to assure the provision of
safe care to patients.
Surveyor Guidance:
Verify that a qualified physician is responsible for the direction of all anesthesia/sedation services offered hospital
wide. This may include, but is not limited to:
•
Surgical Services – for inpatient and outpatient surgical services (including Endoscopy and other
outpatient settings);
•
Obstetrical and Gynecological Services;
•
Emergency Department;
•
Medical Imaging and Nuclear Medicine Services; and,
•
Outpatient Clinics or other settings where anesthesia/sedation services are provided.
Review the defined scope of responsibilities or similar documentation that describes this role within the hospital. This
individual will be responsible for planning, directing and monitoring all anesthesia/sedation services. The other
responsibilities will encompass the implementation of staffing schedules (including on-call services).
Review the criteria and qualifications for physicians and other practitioners for attaining privileges for administering
anesthesia/sedation (sample various physicians and practitioners with these privileges). This is most commonly
located within the Medical Staff Bylaws or in a separate policy that governs these activities. Verify that these
privileges have been granted in accordance with the physician or practitioner’s scope of practice, State law, and that
the criteria and qualifications include competencies, training, education and (if required) experience regarding the
administration of anesthesia/sedation.
Review the qualifications of individuals authorized to administer general anesthesia, regional anesthesia and
monitored anesthesia, including deep sedation/analgesia to determine if they satisfy the requirements.
Determine that there is documentation of current licensure or current certification status for all persons
administering anesthesia.
Determine that there is documentation of current licensure and, as applicable, current certification for all persons
administering anesthesia.
Determine if the state is an “opt-out state” and therefore permits CRNAs to administer anesthesia without
supervision.
Review the hospital’s policies and procedures governing supervision of CRNA’s and anesthesiologist’s assistants and
determine whether they comply with the regulatory requirements.
Review the qualifications of individuals authorized to furnish other anesthesia services, to determine if they are
consistent with the hospital’s anesthesia service policies.
Verify that the anesthesia/sedation services are planned and organized in a manner in which these services are
continuously monitored, and appropriate to the scope of services offered.
Verify that anesthesia/sedation services are under the direction of a doctor of medicine or osteopathy.
In most cases, the physician responsible for the direction of these services will be an anesthesiologist. In the event
it is not an anesthesiologist, review the qualifications of the physician responsible for these services to see that he or
she is qualified to do so and has been appointed by the medical staff and governing body.
Verify that anesthesia services are integrated into the hospital’s QMS oversight.
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AS.2 ADMINISTRATION
Anesthesia shall only be administered by the following:
SR.1 A qualified anesthesiologist or a doctor of medicine or osteopathy (other than an anesthesiologist);
SR.2 A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law;
SR.3 A certified registered nurse anesthetist (CRNA) as defined in 42 CFR Section 410.69(b), who is under
the supervision of the operating practitioner or of an anesthesiologist who is immediately available if
needed;
SR.4 For CRNAs to be exempt from the CMS supervision requirement, the governor of the State must
have received an exemption from CMS for that particular State;
SR.5 An anesthesiologist’s assistant as defined in 42 CFR Section 410.69(b), if approved by State law,
who is under the supervision of an anesthesiologist who is immediately available if needed.
SR.6 If anesthesia services are provided for labor and delivery, the same standard of coverage as that of
operating room anesthesia will be provided and comply with the recommendations of the American
Society of Anesthesiology.
SR.7 If a patient has received epidural analgesia, there will be a physician or other qualified licensed
practitioner immediately available to manage any complication for the analgesia or the specific
obstetrical condition.
Interpretive Guidelines:
The hospital’s medical staff will define the criteria and qualifications for those physicians who have privileges for
administering anesthesia/sedation in accordance with State laws and acceptable standards of practice.
AS.2, SR.1 – SR.5 defines those physicians and other practitioners who can administer anesthesia/sedation.
Anesthesia Services Policies
The medical staff bylaws or rules and regulations must include criteria for determining the anesthesia service
privileges to be granted to an individual practitioner and a procedure for applying the criteria to individuals
requesting privileges, as required for any type of anesthesia services, including those not subject to the anesthesia
administration requirements. The hospital’s governing body (or individual responsible) must approve the specific
anesthesia service privileges for each practitioner who furnishes anesthesia services, addressing the type of
supervision, if any, required. The privileges granted must be in accordance with State law and hospital policy. The
type and complexity of procedures for which the practitioner may administer anesthesia must be specified in the
privileges granted to the individual practitioner.
Per the ASA position statement, “Definition of “Immediately Available” When Medically Directing”
(https://www.asahq.org/quality-and-practice-management/standards-and-guidelines):
“An anesthesiologist who is personally performing an anesthetic is exclusively and completely dedicated to that case.
A medically directing anesthesiologist is immediately available if s/he is in physical proximity that allows the
anesthesiologist to re-establish direct contact with the patient to meet medical needs and any urgent or emergent
clinical problems. These responsibilities may also be met through coordination among anesthesiologists of the same
group or department.
Guidelines for Developing Policy Regarding Immediate Availability:
Differences in the design and size of various facilities make it impossible to define a universally applicable specific
time or distance for physical proximity. The physical layout of the operating room and other anesthetizing locations
are important in determining how medically directing anesthesiologists can fulfill the requirement to be immediately
available.
The hospital should establish objective and specific written policies regarding immediate availability that consider
objective elements such as distance, a map or time that recognizes the specific local environment, and factors that
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should be taken into account so that a medically directing anesthesiologist is available to immediately conduct
hands- on intervention for each patient. The demands of particular surgical and other diagnostic or therapeutic
procedures and the clinical needs of patients may further restrict what constitutes immediate availability under
specific circumstances.
When a hospital permits operating practitioners to supervise a CRNA administering anesthesia, the medical staff
bylaws or rules and regulations must specify for each category of operating practitioner, the type and complexity of
procedures that category of practitioner may supervise. However, individual operating practitioners do not need to
be granted specific privileges to supervise a CRNA.
Who May Administer Anesthesia
Topical/ Local Anesthetics, Minimal Sedation, or Moderate Sedation:
The requirements concerning who may administer anesthesia do not apply to the administration of topical or local
anesthetics, minimal sedation, or moderate sedation. However, the hospital must have policies and procedures,
consistent with State scope of practice law, governing the provision of these types of anesthesia services. Further,
the hospital must assure that all anesthesia services are provided in a safe, well-organized manner by qualified
personnel.
General anesthesia, regional anesthesia and monitored anesthesia, including deep sedation/analgesia, may only be
administered by:
•
A qualified anesthesiologist;
•
An MD or DO (other than an anesthesiologist);
•
A dentist, oral surgeon or podiatrist who is qualified to administer anesthesia under State law;
•
A CRNA who is supervised by the operating practitioner or by an anesthesiologist who is immediately
available if needed (for CRNAs to be exempt from the CMS supervision requirement, the governor
of the State must have received an exemption from CMS for that particular State); or,
•
An anesthesiologist’s assistant under the supervision of an anesthesiologist who is immediately
available if needed.
Administration by an MD/DO/dentist/oral surgeon/podiatrist
The hospitals anesthesia services policies must address the circumstances under which an MD or DO who is not an
anesthesiologist, a dentist, oral surgeon or podiatrist is permitted to administer anesthesia. In the case of a dentist,
oral surgeon or podiatrist, administration of anesthesia must be permissible under State law and comply with all
State requirements concerning qualifications. The hospital should conform to generally accepted standards of
anesthesia care when establishing policies governing anesthesia administration by these types of practitioners as
well as MDs or DOs who are not anesthesiologists.
Administration by a CRNA
Unless the hospital is located in a State that has chosen to opt out of the CRNA supervision requirements, a CRNA
administering general, regional and monitored anesthesia must be supervised either by the operating practitioner
who is performing the procedure, or by an anesthesiologist who is immediately available.
The hospital should conform to generally accepted standards of anesthesia care when establishing policies for
supervision by the operating practitioner. An anesthesiologist is considered “immediately available” when needed by
a CRNA under the anesthesiologist’s supervision only if he/she is physically located within the same area as the
CRNA, e.g., in the same operative suite, or in the same labor and delivery unit, or in the same procedure room, and
not otherwise occupied in a way that prevents him/her from immediately conducting hands-on intervention, if
needed.
If the hospital is located in a State where law or regulation permits or where the Governor has submitted a letter to
CMS attesting that he or she has consulted with State Boards of Medicine and Nursing about issues related to access
to and the quality of anesthesia services in the State and has concluded that it is in the best interests of the State’s
citizens to opt-out of the current physician supervision requirement, and that the opt-out is consistent with State
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law, then a hospital may permit a CRNA to administer anesthesia without operating practitioner or anesthesiologist
supervision. A list of States that have opted out of the CRNA supervision requirement may be found at
http://www.aana.com/advocacy/stategovernmentaffairs/Pages/Federal-Supervision-Rule-Opt-Out-Information.aspx
A CRNA is defined in 42 CFR Section 410.69(b) as a “…registered nurse who: (1) is licensed as a registered
professional nurse by the State in which the nurse practices; (2) meets any licensure requirements the State
imposes with respect to non-physician anesthetists; (3) has graduated from a nurse anesthesia educational program
that meets the standards of the Council on Accreditation of Nurse Anesthesia Programs, or such other accreditation
organization as may be designated by the Secretary; and (4) meets the following criteria: (i) has passed a
certification examination of the Council on Certification of Nurse Anesthetists, the Council on Recertification of Nurse
Anesthetists, or any other certification organization that may be designated by the Secretary; or (ii) is a graduate of
a program described in paragraph (3) of this definition and within 24 months after that graduation meets the
requirements of paragraph (4)(i) of this definition.”
Administration by an anesthesiologist’s assistant
An anesthesiologist’s assistant may administer anesthesia when under the direct supervision of an anesthesiologist.
The anesthesiologist must be immediately available if needed. An anesthesiologist is considered “immediately
available” to assist the anesthesiologist’s assistant under the anesthesiologist’s supervision only if he/she is
physically located within the same area as the anesthesiologist’s assistant, e.g., in the same operative suite, or in
the same labor and delivery unit, or in the same procedure room, and not otherwise occupied in a way that prevents
him/her from immediately conducting hands-on intervention, if needed.
An anesthesiologist’s assistant is defined in 42 CFR Section 410.69(b) as a “…person who – (1) works under the
direction of an anesthesiologist; (2) is in compliance with all applicable requirements of State law, including any
licensure requirements the State imposes on non-physician anesthetists; and (3) is a graduate of a medical school-
based anesthesiologist’s assistant education program that – (A) is accredited by the Committee on Allied Health
Education and Accreditation; and (B) includes approximately two years of specialized basic science and clinical
education in anesthesia at a level that builds on a premedical undergraduate science background.”
Surveyor Guidance:
Verify that a qualified physician is responsible for the direction of all anesthesia/sedation services offered hospital
wide. This may include, but is not limited to:
•
Surgical Services – for inpatient and outpatient surgical services (including Endoscopy and other
outpatient settings);
•
Obstetrical and Gynecological Services;
•
Emergency Department;
•
Medical Imaging and Nuclear Medicine Services; and,
•
Outpatient Clinics or other settings where anesthesia/sedation services are provided.
Review the defined scope of responsibilities or similar documentation that describes this role within the hospital. This
individual will be responsible for planning, directing and monitoring all anesthesia/sedation services. The other
responsibilities will encompass the implementation of staffing schedules (including on-call services).
Review the criteria and qualifications for physicians and other practitioners for attaining privileges for administering
anesthesia/sedation (sample various physicians and practitioners with these privileges). This is most commonly
located within the Medical Staff Bylaws or in a separate policy that governs these activities.
Verify that these privileges have been granted in accordance with the physician or practitioner’s scope of practice,
State law, and that the criteria and qualifications include competencies, training, education and (if required)
experience regarding the administration of anesthesia/sedation.
Review the qualifications of individuals authorized to administer general anesthesia, regional anesthesia and
monitored anesthesia, including deep sedation/analgesia to determine if they satisfy the requirements.
Determine that there is documentation of current licensure or current certification status for all persons
administering anesthesia.
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Determine that there is documentation of current licensure and, as applicable, current certification for all persons
administering anesthesia.
Determine if the state is an “opt-out state” and therefore permits CRNAs to administer anesthesia without
supervision in accordance with CMS CoP 482.52(c). As of February 2018, seventeen States and the U.S. Territory
Guam have chosen to opt-out of the CRNA physician supervision regulation. The States are: California, Iowa,
Nebraska, Idaho, Minnesota, New Hampshire, New Mexico, Kansas, North Dakota, Washington, Alaska, Oregon,
South Dakota, Wisconsin, Montana, Colorado, and Kentucky.
Review the hospital’s policies and procedures governing supervision of CRNA’s and anesthesiologist’s assistants and
determine whether they comply with the regulatory requirements.
Review the qualifications of individuals authorized to furnish other anesthesia services, to determine if they are
consistent with the hospital’s anesthesia service policies.
AS.3 POLICIES AND PROCEDURES
SR.1 Anesthesia services must be consistent with the needs and resources of the organization. Policies on
anesthesia/sedation procedures must include the delineation of pre-anesthesia and post-anesthesia
responsibilities.
SR.2 The policies must ensure that the following are provided for each patient:
SR.2a A pre-anesthesia evaluation must be performed for each patient who will receive general,
regional or monitored anesthesia. Patients who will be receiving moderate sedation must be
monitored and evaluated before, during and after a procedure by a trained practitioner,
however a pre-anesthesia evaluation is not required because moderate sedation is not
considered to be “anesthesia” and is not subject to this requirement.
SR.2b A pre- anesthesia evaluation shall include;
SR.2b(1) A review of the medical history,
SR.2b(2) An interview and examination of the patient,
SR.2b(3) A documented airway assessment,
SR.2b(4) An anesthesia risk assessment,
SR.2b(5) An anesthesia, drug and allergy history,
SR.2b(6) Performed by an individual, qualified, and privileged to administer
anesthesia/sedation, within 48 hours prior to inpatient or outpatient surgery or
procedure requiring anesthesia services. (Delivery of the first dose of
medications for the purpose of inducing anesthesia marks the end of the 48-hour
time frame).
SR.2c An intra-operative anesthesia record must be present for each patient who will receive
general, regional or monitored anesthesia. Patients who will be receiving moderate sedation
must be monitored and evaluated before, during and after a procedure by a trained
practitioner, however an intra-operative anesthesia record is not required because
moderate sedation is not considered to be “anesthesia” and is not subject to this
requirement.
SR.2d For inpatient and outpatient surgery, a post-anesthesia evaluation for proper anesthesia
recovery is completed and documented within 48 hours after surgery by the individual who
administers the anesthesia or, if approved by the medical staff, by any individual qualified
and credentialed to administer anesthesia.
SR.2d(1) The elements of an adequate post-anesthesia evaluation should be clearly
documented and conform to current standards of anesthesia care, including:
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SR.2d(1)i Respiratory function, including respiratory rate, airway patency, and
oxygen saturation;
SR.2d(1)ii Cardiovascular function, including pulse rate and blood pressure;
SR.2d(1)iii Mental status;
SR.2d(1)iv Temperature;
SR.2d(1)v Pain;
SR.2d(1)vi Nausea and vomiting; and,
SR.2d(1)vii Postoperative hydration.
Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be
necessary.
SR.2d(2) A post-anesthesia evaluation for anesthesia recovery is required for each patient
who will receive general, regional or monitored anesthesia. Patients who will be
receiving moderate sedation must be monitored and evaluated before, during and
after a procedure by a trained practitioner, however, a post-anesthesia evaluation
is not required because moderate sedation is not considered to be “anesthesia”
and is not subject to this requirement.
SR.2d(3) While the evaluation should begin in the PACU/ICU or other designated recovery
location, it may be completed after the patient is moved to another inpatient
location or, for same day surgeries, if State law and hospital policy permits, after
the patient is discharged, so long as it is completed within 48 hours. The 48-hour
timeframe for completion and documentation of the post- anesthesia evaluation is
an outside parameter. Individual patient risk factors may dictate that the
evaluation be completed and documented sooner than 48 hours. This should be
addressed by hospital policies and procedures.
Interpretive Guidelines:
The hospital must develop and implement policies and procedures regarding the administration of
anesthesia/sedation. This will include the responsibilities for both pre-anesthesia/sedation and
postanesthesia/sedation. These policies and procedures must address the following:
Pre-anesthesia/sedation responsibilities:
•
Physical examination of the airway (by those qualified and privileged to administer sedation) must be
performed within 48 hours of administration of anesthesia/sedation;
•
Assessment of risk to the patient for receiving anesthesia/sedation;(within 30 days/update within 48
hours)
•
Drug and allergy history regarding anesthesia/sedation;(within 48 hours of induction)
•
Physical condition of the patient prior to induction of anesthesia/sedation;(within 48 hours of induction)
•
Patient consent for administration of anesthesia/sedation;
•
Equipment requirements, as well as the monitoring, inspection, testing and maintenance of
anesthesia/sedation equipment in the hospital’s biomedical equipment program;
•
Infection control practices in place; and,
•
Safety measures in place in areas where anesthesia/sedation is administered (including a protocol for
supportive life functions, e.g., cardiac and respiratory emergencies.
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Reporting and documentation requirements
•
Intra-operative anesthesia/sedation/sedation record including:
•
Name and hospital identification number of the patient;
•
Name(s) of practitioner(s) who administered anesthesia/sedation, and as applicable, the name and
profession of the supervising anesthesiologist or operating practitioner;
•
Name, dosage, route and time of administration of drugs and anesthesia/sedation agents;
•
Techniques used and patient position(s), including the insertion of any intravascular or airway devices
Name and amount of IV fluids;
•
Blood or blood products; if applicable
•
Time-based documentation of vital signs as well as oxygenation and ventilation parameters;
•
Any complications, adverse reactions, or problems occurring during anesthesia, including time and
description of symptoms, vital signs, treatments rendered, and patient’s response to treatment.
Post-anesthesia/sedation follow-up report including:
•
Cardiopulmonary status;
•
Level of consciousness;
•
Any follow-up care and/or observations;
•
Any complications occurring during post-anesthesia/sedation recovery; and,
•
Any follow-up care needed or patient instructions given.
If the required elements of the post-anesthesia evaluation are available elsewhere in the medical record, it is
acceptable if referred to and authenticated as accurate by the individual qualified to administer anesthesia. For
example, the provider’s post-anesthesia evaluation documentation might include an attestation that the provider
reviewed the required evaluation elements as part of the post-operative assessment and evaluation.
Note: This report must be completed and documented within 48 hours following the procedure in which
anesthesia/sedation has been administered.
All anesthesia patients shall be discharged from the hospital in the company of a responsible adult unless
exempted by the practitioner who performed the surgical procedure.
Surveyor Guidance:
Review the policies developed on anesthesia/sedation procedures.
Verify that the anesthesia/sedation services where provided incorporates that has been listed in interpretive
guidelines.
Sample patient medical records to verify the following:
•
Pre-anesthesia/sedation evaluation that includes all of the defined elements
•
An intra-operative anesthesia/sedation record documenting all pertinent events taking place during
anesthesia/sedation that includes all of the defined elements
•
A post-anesthesia/sedation follow-up report is written for each patient by an individual who is qualified
to administer anesthesia, within 48 hours after surgery. Verify that this report includes all of the
defined elements .
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•
A post-anesthesia/sedation evaluation for proper anesthesia/sedation recovery in accordance with
hospital policies and procedures. Verify that this evaluation includes those items stated within the
interpretive guidelines.
Verify that the post-anesthesia evaluation is completed by an individual qualified and credentialed to administer
anesthesia and in accordance with State law and hospital policies and procedures approved by the medical staff.
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LABORATORY SERVICES (LS)
LS.1 ORGANIZATION
SR.1 The organization shall maintain, or have available, adequate laboratory services, either directly or
through contractual services, to meet the needs of its patients.
SR.2 The organization shall ensure that all laboratory services provided to its patients are performed in a
laboratory certified in accordance with 42 CFR §493.
SR.3 The organization shall have the capability to perform emergency laboratory services 24 hours a day.
SR.4 A documented scope of laboratory services shall be available to the medical staff.
SR.5 The laboratory shall have policies and practices for proper receipt and reporting of tissue specimens.
SR.6 The medical staff and a pathologist shall determine which tissue specimens require a macroscopic
(gross) examination and which require both macroscopic and microscopic examinations.
Interpretive Guidelines:
The hospital must maintain, or have available, adequate laboratory services whenever its patients need those
services. The hospital may maintain laboratory services at the hospital or may make laboratory services available
through contractual agreements. All laboratory services will be provided in a laboratory that has been certified in
accordance with 42 C.F.R. §493.
The hospital will have a documented scope and complexity of the laboratory services available. This will include the
capability to perform necessary laboratory studies, including blood gas analysis and electrolyte determination 24
hours a day. Whether provided directly or through a contractual arrangement, these services must be provided in
accordance with Clinical Laboratory Improvement Act (CLIA) requirements. The hospital shall have a current CLIA
certificate appropriate to the level of services performed.
The medical staff and a pathologist shall determine which tissue specimens require a macroscopic (gross)
examination for both macroscopic and microscopic examinations. There will be documented policies and practices for
proper receipt and reporting of tissue specimens.
Surveyor Guidance:
Determine the total number of laboratories, the location of each laboratory, and every location where laboratory
procedures are performed.
Determine which services are provided directly by the facility and which are provided through contractual
arrangements. If provided under a contractual arrangement, verify that the provider has been approved by the
medical staff and governing body.
Validate that the laboratory services are provided are operating under a current CLIA certificate.
Review a sampling of records and determine if the services, including emergency services, are provided in
accordance with the hospital’s policies.
Review a sampling of tissue records (accession records, worksheets, and test reports) to verify whether the
laboratory follows the written protocol.
Review the written policies and tissue reports to assure that tissue specimens are examined in accordance with the
written policies.
LS.2 POTENTIALLY INFECTIOUS BLOOD AND PRODUCTS
Potentially infectious blood (such as human immunodeficiency virus (HIV) or hepatitis C virus (HVC) and blood
products (as identified in 21 CFR 610.47) can come from prior collections from a donor who: tested negative at the
time of donation but tests repeatedly reactive for the antibody to the HIV or HCV on a later donation, tests positive
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on the FDA-licensed, more specific test or other follow up testing recommended or required by FDA, and the timing
of seroconversion cannot be precisely estimated.
SR.1 If an organization regularly uses the services of an outside blood bank, it shall have an agreement
with the blood bank that governs the procurement, transfer, and availability of blood and blood
products.
SR.2 The agreement shall require that the blood bank promptly notify the organization of the following:
SR.2a Within three calendar days if the blood bank supplied blood and blood products collected
from a donor who tested negative at the time of donation but tests repeatedly reactive for
the antibody to HIV or HCV on a later donation; and,
SR.2b The results of the FDA licensed more specific test or other follow-up testing recommended or
required by the FDA completed within 45 calendar days after the donor’s repeatedly reactive
screening test for HIV or HCV.
SR.2c Within 3 calendar days after the blood bank supplied blood and blood components collected
from an infectious donor, whenever such records are available (as set forth at 21 CFR
610.48(b)(3)).
SR.2d Quarantine of blood and blood products pending completion of testing: If the blood bank
notifies the organization of the repeatedly reactive HIV or HCV screening test results, the
organization shall determine the disposition of the blood or blood product and quarantine all
blood and blood products from previous donations in inventory.
SR.3 If the blood bank notifies the organization that the result of the FDA-licensed, more specific test or
other follow up testing recommended or required by FDA is negative, absent other informative test
results, the organization may release the blood and blood products from quarantine.
SR.4. If the blood bank notifies the organization that the result of the FDA-licensed, more specific test or
other follow up testing recommended or required by FDA is positive, the organization shall dispose of
the blood and blood products in accordance with 21 CFR §606.40 and notify the transfusion
recipients according to LS.3.
SR.5 If the blood bank notifies the organization that the result of the FDA-licensed, more specific test or
other follow up testing recommended or required by FDA is indeterminate, the organization must
destroy or label prior collections of blood and blood products held in quarantine (as set forth at 21
CFR 610.46(b)(2), 610.47(b)(2), and 610.48(c)(2)).
SR.6 The hospital must maintain adequate records which identify the source and disposition of all units of
blood and blood components for no less than 10 years from the date of disposition in manner
reflecting QM.2, SR.3b and are stored in such a manner they are available for prompt retrieval.
SR.6a The organization will have a plan in place to transfer these records to another hospital or
other entity if the hospital ceases its operations for any reason. The organization will have
allocated adequate funding to execute this plan when necessary.
Interpretive Guidelines:
This standard requires that the hospital have a system in place to take appropriate action when notified that blood or
blood products received are at increased risk of transmitting potential human immunodeficiency virus (HIV) or
hepatitis C virus (HCV).
Definition: The timeframe, also referred to as the “window period”, is defined as that period early in infection when
the antibody to HIV or HCV is not detectable by the screening test.
Definition: The term “repeatedly reactive” means that the initial HIV or HCV antibody screening test is reactive,
retested in duplicate, and one or both of the duplicate tests are reactive. If repeatedly reactive, a licensed, more
specific (confirmatory) test (e.g. Western Blot) is used to confirm the presence of HIV or HCV.
Definition: “Look back” is considered to include: the quarantine of products from a window period donor; notification
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of consignees (facilities having received such window period products) to quarantine those products; and on
completion of the licensed, more specific (confirmatory) test, notification of any transfusion recipient.
Despite the best practices of blood banks, a person may have donated blood during the window period. If the donor
attempts to donate blood at a later date, the screening test for the antibody to HIV or HCV may, at that time, be
repeatedly reactive. Under such circumstances, previously collected blood and blood products would be at increased
risk for transmitting HIV or HCV and a recipient of blood or blood products collected during the window period would
not know whether the donor was infected with HIV or HCV at the time of the previous donations.
If the hospital regularly uses the services of an outside blood bank, it shall have an agreement with the blood bank
to govern the procurement, transfer, and availability of blood and blood products. This applies to hospitals that
receive blood and blood products from an outside source and only performs compatibility (cross match) testing in
preparation for transfusion to patients.
The agreement(s) and practice policies developed between the hospital and blood bank must be consistent with
applicable Federal, State, and local laws, and written with the means of addressing any changes in FDA or CMS
requirements and can be incorporated into operating procedures rather than by constructing a new agreement.
Under certain circumstances, such as blood availability emergencies, hospitals may receive blood from a source
other than the contracted blood bank. FDA regulations require a blood bank to notify the hospital in the event it
furnished the hospital with potentially HIV or HCV infected blood.
The agreement between the notification process and procedure shall include the elements as stated in LS.2, SR.2(a)
– SR.2(c).
If the blood bank notifies the organization that the result of the FDA-licensed, more specific test or other follow up
testing recommended or required by FDA is negative, absent other informative test results, the organization may
release the blood and blood products from quarantine.
•
The hospital’s policy should reflect that release (from quarantine) of potentially HIV or HCV infected
blood is possible only if the more specific (confirmatory) test is negative, and the blood bank’s (the
facility that notified the hospital) records show the donor has no other informative test results that
show evidence of HIV or HCV infection. “Other” informative tests are tests that a blood bank may
voluntarily perform (e.g. HIV antigen tests, viral cultures).
If the blood bank notifies the organization that the result of the FDA-licensed, more specific test or other follow up
testing recommended or required by FDA is positive, the organization shall dispose of the blood and blood products
in accordance with 21 C.F.R. §606.40.
•
If these tests are positive, the blood and blood products are disposed of if still available. The blood
bank will communicate this information to the hospital. If no other informative test results exist, the
hospital may release the blood and blood products from quarantine. If other informative test results
exist that indicate possible HIV infection, the hospital must dispose of the blood and blood products.
Surveyor Guidance:
The hospital’s laboratory will be determined to be in compliance with the requirements of LS.2 if the hospital’s
laboratory maintains current accreditation by the College of American Pathology (CAP) or Commission on Office
Laboratory Accreditation (COLA). If the hospital laboratory is not CAP or COLA Accredited, then the following must be
verified:
Validate that the written agreement with the blood bank allows for notification expectations (per LS.2, SR.2) and
approval by an appropriate hospital representative.
Verify the hospital’s policy for labeling and quarantining potentially HIV or HCV infected blood and blood products.
Validate the procedure for the disposal of infected blood products, when warranted.
Verify the procedure followed when the hospital is notified that it had received potentially infectious blood and blood
products.
Verify that the hospital policy addresses the notification process when it receives potentially HIV or HCV infectious
blood or blood products.
Verify that the hospital maintains adequate records which identify the source and disposition of all units of blood and
blood components for no less than 10 years from the date of disposition in manner reflecting QM.2, SR.3b and are
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stored in such a manner they are available for prompt retrieval.
Verify that the organization has a plan in place to transfer these records to another hospital or other entity if the
hospital ceases its operations for any reason and that the organization has allocated adequate funding to execute
this plan when necessary.
LS.3 PATIENT NOTIFICATION
If the organization has administered potentially HIV or HCV infectious blood or blood products, either directly
through its own blood bank or under an agreement, or released such blood or blood products to another entity or
appropriate individual, the organization shall take the following actions:
SR.1 The organization must make reasonable attempts to promptly notify the patient, and/ or patient’s
attending physician (the physician of record) or the physician who ordered the blood or blood
product. (See LS.3, SR.7 regarding notification of legal representative when applicable).
SR.2 Request that the physician immediately notify the patient, or other individual of the need for HIV
testing and counseling.
SR.3 If the physician is unavailable, declines to make the notification, or later informs the organization
that he or she was unable to notify the patient, promptly make at least three attempts to notify the
patient, legal representative or relative of the need for HIV or HCV testing and counseling.
SR.4 Document in the patient’s medical record the notification or attempts to give the required
notification.
SR.5 Timeframe for notification:
For donors tested on or after February 20, 2008 – for notifications resulting from donors tested on or
after February 20, 2008 as set forth in 21 CFR 610.46 and 21 CFR 610.47:
The notification effort begins when the blood bank notifies the organization that it received potentially HIV or HCV
infectious blood and blood products. The organization shall make reasonable attempts to give notification for no less
than twelve (12) weeks unless:
SR.5a The patient is located and notified; or
SR.5b The organization is unable to locate the patient and documents in the patient’s medical
record the extenuating circumstances beyond the organization’s control that caused the
notification timeframe to exceed 12 weeks.
For donors tested before February 20, 2008 – for notifications resulting from donors tested before
February 20, 2008 as set forth in 21 CFR Section 610.48(b) and (c):
SR.5c The notification effort begins when the blood bank notifies the organization that it received
potentially HIV or HCV infectious blood and blood products. The organization shall make
reasonable attempts to give notification and must complete the actions within one year of
the date on which the organization received notification from the blood bank.
Note: HCV notification requirements resulting from donors tested before February 20, 2008 as set
forth in 21 CFR 610.48 is set to expire on August 24, 2015.
SR.6 Content of notification: The notification shall include the following information:
SR.6a A basic explanation of the need for HIV or HCV testing and counseling;
SR.6b Enough oral or written information so that the transfused patient can make an informed
decision about whether to obtain HIV or HCV testing and counseling; and,
SR.6c A list of programs or places where the patient can obtain HIV or HCV testing and counseling,
including any requirements or restrictions the program may impose.
SR.7 Policies and Procedures: The organization shall establish policies and procedures for notification and
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documentation that conform to Federal, State, and local laws, including requirements for
confidentiality and medical records. A notification to legal representative or relative shall address the
following:
SR.7a If the patient has been adjudged incompetent by a State court, the physician or organization
shall notify a legal representative designated in accordance with State law;
SR.7b If the patient is competent, but State law permits a legal representative or relative to receive
the information on the patient’s behalf, the physician or organization shall notify the patient
or his/her legal representative or relative; and,
SR.7c If the patient is deceased, the physician or organization shall continue the notification
process and inform the deceased patient’s legal representative or relative.
SR.7d If the patient is a minor, the physician or organization must notify the patient’s parents or
legal guardian.
Interpretive Guidelines:
The hospital must develop policies and procedures in order to meet notification requirements. The physician of
record should notify the patient that he or she received potentially HIV or HCV infectious blood. In the event that
the physician declines for appropriate reasons, the hospital then has the responsibility to notify the patient or legal
representative. The hospital may designate an appropriate, competent hospital representative to inform the patient.
This may be another physician, such as the medical director of the transfusion service, an infection control officer, a
nurse, a clinical laboratory scientist, a social worker, or a non-physician with a medical background.
This requirement also applies when the hospital transfusion service furnishes blood or blood products to another
facility, such as an ambulatory surgery center, clinic, nursing facility, or home setting (a home health agency). The
hospital retains responsibility for patient notification.
The hospital must make reasonable attempts to notify the physician (of record) or the physician who ordered the
blood or blood product. If after these reasonable attempts for notification, the hospital is not able to locate the
patient within the one-week notification period, it is not expected to continue its search. However, there is no limit
on how much time a hospital may choose to expend on this effort.
The hospital must document information related to notification, (e.g. contacting physician, telephone log, return
receipt from a certified or registered letter), and this becomes part of the patient’s medical record.
The policies and procedures for the notification process must conform to all Federal, State, and local laws regarding
confidentiality.
When the physician accepts the responsibility for notification, the hospital is not required to follow up with the
physician to determine whether notification occurred. It is expected that the physician would inform the hospital if
notification did not occur, but this is part of professional relationships and not a requirement.
When the patient is notified, the following information must be provided:
•
A basic explanation of the need for HIV or HCV testing and counseling;
•
Enough oral or written information so that the transfused patient can make an informed decision
about whether to obtain HIV testing and counseling; and,
•
A list of programs or places where the patient can obtain HIV or HCV testing and counseling, including
any requirements or restrictions the program may impose.
Referral for testing and counseling will be made to a physician or organization that provides high quality HIV or HCV
testing and has extensive experience in providing HIV or HCV counseling. In addition, the patient should be told
about any requirements or restrictions the programs may impose, such as, whether the program requires a fee, a
physician request form, identification or public assistance cards, or a residency requirement. The CDC National AIDS
Hotline operates a toll-free number (1-800-342-2437) 24 hours a day that the hospital or physician can give to the
patient for more assistance. CDC's also operates a toll-free hepatitis hotline at 1-888-4HEPCDC (1-888-443-7232).
In addition, the CDC maintains a Web site with information on hepatitis for both health-care professionals and the
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general public, including specific materials for people who received blood transfusions in the past. The Web address
is www.cdc.gov/hepatitis.
If the patient in question is incompetent or unable to comprehend the information being provided, or the physician
or hospital believes the information should not be given to the patient, and State law permits a legal representative
or relative to receive information on the patient’s behalf, then the physician must notify the patient’s representative
or relative. Upon learning of the death of the transfused patient, the hospital must pursue the notification process to
inform the patient’s family. It would not be appropriate for a physician or hospital to determine that the patient or
someone acting on his or her behalf need not be informed.
A notification to legal representative will be provided when:
•
The patient has been adjudged incompetent by a State court, the physician or organization;
•
The patient is competent, but State law permits a legal representative or relative to receive the
information on the patient’s behalf; or,
•
The patient is deceased.
Surveyor Guidance:
The hospital’s laboratory will be determined to be in compliance with the requirements of LS.3 if the hospital’s
laboratory maintains current accreditation by the College of American Pathology (CAP). If the hospital laboratory is
not CAP Accredited, then the following must be verified:
•
Validate that, when required, the hospital documents the notification efforts in the patient’s medical
record, including any extenuating circumstances that prevented patient notification within the
12-week timeframe.
•
Verify that the hospital has a process in place to assist the patient in seeking testing and counseling.
•
Verify the process regarding physician explanation to the patient of the need for testing and
counseling and in the event, that the physician declines, that the process is followed by the
hospital.
•
Verify the information the hospital makes available to the patient who is transfused with potentially
HIV or HCV infectious blood or blood products.
•
Review and verify the hospital’s notification procedures to ordering and/or responsible physician and
the patient.
•
Review and verify the defined circumstances when the hospital deems it necessary to notify someone
other than the patient who received potentially HIV or HCV infectious blood or blood products
and ensure that the hospital is aware of the State law and that the law permits a legal
representative or relative to receive information on the patient’s behalf.
LS.4 GENERAL BLOOD SAFETY
For look-back activities only related to new blood safety issues that are identified after August 27, 2007, the
organization must comply with FDA regulations as they pertain to blood safety issues in the following areas:
SR.1 Appropriate testing and quarantining of infectious blood and blood components.
SR.2 Notification and counseling of recipients that may have received infectious blood and blood
components.
Interpretive Guidelines:
Multiple layers of safeguards, including donor screening and testing, are used to reduce the risk of transmitting
infection through blood transfusion. However, a person may donate blood early in infection, during the period when
the viral marker is not detectable by a screening test, but the infectious agent is present in the donor's blood (the
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"window period").
Definition: “Look back” is considered to include: the quarantine of products from a window period donor; notification
of consignees (facilities having received such window period products) to quarantine those products; and on
completion of the licensed, more specific (confirmatory) test, notification of any transfusion recipient.
•
See FDA Publication: Guidance for Industry - “Lookback” for Hepatitis C Virus (HCV): Product
Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of
Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV (August 2007)
•
See FDA Publication: Guidance for Industry - Nucleic Acid Testing (NAT) for Human
Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition,
and Donor Deferral and Reentry (Draft Guidance, July 2005)
Surveyor Guidance:
Verify that the organization’s laboratory is following FDA regulations pertaining to blood safety issues.
Discuss the process for Notification and counseling of recipients that may have received infectious blood and blood
components
Process for verification of the right blood product for the right patient.
Verify that those administering blood transfusions and intravenous medications are working within their scope of
practice in accordance with State law and hospital policy.
Review transfusion records to verify the process followed is consistent with the training provided and policies and
procedures are followed.
Discuss the process for addressing blood transfusion reactions and the procedure to be followed when this occurs.
The hospital’s laboratory will be determined to be in compliance with the requirements of LS.4 if the hospital’s
laboratory maintains current accreditation by the College of American Pathology (CAP). If the hospital laboratory is
not CAP Accredited, then the following must be verified:
Verify that the organization’s laboratory is following FDA regulations pertaining to blood safety issues.
Discuss the process for Notification and counseling of recipients that may have received infectious blood and blood
components
Process for verification of the right blood product for the right patient.
Verify that those administering blood transfusions and intravenous medications are working within their scope of
practice in accordance with State law and hospital policy.
Review transfusion records to verify the process followed is consistent with the training provided and policies and
procedures are followed.
Discuss the process for addressing blood transfusion reactions and the procedure to be followed when this occurs
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RESPIRATORY CARE SERVICES (RC)
RC.1 ORGANIZATION
SR.1 The organization of the respiratory care services shall be appropriate to the scope and complexity of
the services offered.
SR.2 Respiratory care services provided at the organization shall be delivered in accordance with medical
staff directives.
SR.3 There shall be a director of respiratory care services who is a doctor of medicine or osteopathy with
the knowledge, experience, and capabilities to supervise and administer the service properly.
SR.4 There shall be appropriate numbers of respiratory therapists, respiratory therapy technicians, and
other qualified personnel whose training meets the qualifications specified by the medical staff and
State law.
Interpretive Guidelines:
When the hospital provides respiratory care services to patients, the service will be appropriate to the scope and
complexity of the services offered. Respiratory care services shall be delivered in accordance with medical staff
directives and acceptable standards of practice.
Standards of practice include compliance with applicable standards that are set forth in Federal or State laws,
regulations or guidelines, as well as standards and recommendations promoted by nationally recognized professional
organizations (e.g., American Medical Association, American Association for Respiratory Care, American Thoracic
Association, etc.).
Respiratory care services shall be provided under the direction of a doctor of medicine or osteopathy with the
knowledge, experience, and capabilities to supervise and administer the service.
The hospital must provide the appropriate equipment and types and numbers of qualified personnel necessary to
furnish the services offered by the hospital in accordance with acceptable standards of practice.
The scope of diagnostic and/or therapeutic respiratory services offered by the hospital should be defined in writing,
and approved by the medical staff.
Surveyor Guidance:
Verify the scope of respiratory care services provided by the organization and that they are appropriate to the scope
and complexity of services provided and in accordance with acceptable standards of practice.
Review the hospital’s organizational chart to determine the relationship of respiratory care services to other services
provided by the hospital.
Verify that a director has been appointed by the medical staff and governing body. Verify that the director has the
necessary education, experience, and specialized training and has delegated responsibility for operation of
respiratory care services.
Sample of personnel files for respiratory care staff to determine that the personnel meet the qualifications specified
by the medical staff, consistent with State law.
Review how the appropriate staffing is determined and applied for respiratory care services.
RC.2 ORDERS FOR TREATMENT AND INTERVENTIONS
SR.1 All respiratory treatments and interventions shall only be provided under the orders of a qualified
and licensed practitioner who is responsible for the care of the patient, acting within his or her scope
of under State law, and has been authorized by the hospital’s medical staff to order these services in
accordance with the hospital’s policies and procedures and State laws.
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SR.2 All orders for all respiratory treatment and interventions must be documented in the patient’s
medical record in accordance with the requirements defined under the Medical Records (MR) section
of these accreditation requirements.
Surveyor Guidance:
Sample medical records of patients receiving respiratory services to verify that services are provided only upon the
orders of a qualified and licensed practitioner who is responsible for the care of the patient, acting within his or her
scope of under State law, and has been authorized by the hospital’s medical staff to order these services in
accordance with the hospital’s policies and procedures and State laws and that the services are provided in
accordance with those orders.
Sample medical records to ensure that respiratory treatment and interventions are documented accordingly.
RC.3 POLICIES OR PROTOCOLS
Written policies or protocols shall specify:
SR.1 Which personnel are qualified to perform specific procedures; and,
SR.2 The amount of supervision required
Interpretive Guidelines:
The hospital should have policies and procedures (or protocols) for the delivery of respiratory care services that have
been developed and approved by the medical staff.
The policies and procedures (or protocols) should address at least the following:
•
The qualifications, licensure (consistent with State law), education, training and experience of
personnel authorized to perform each type of respiratory care service and whether they may
perform services without supervision; and,
•
The type of personnel qualified to provide the direct supervision.
Other policies and procedures (protocols) should address the following:
•
Equipment operation and the respective preventive maintenance and calibration as required;
•
Safety practices, including infection control measures for equipment, sterile supplies, bio-hazardous
waste, posting of signs, and gas line identification;
•
Handling, storage, and dispensing of therapeutic gases to patients;
•
Cardiopulmonary resuscitation;
•
Pulmonary function testing;
•
Therapeutic percussion and vibration;
•
Bronchopulmonary drainage;
•
Mechanical ventilatory and oxygenation support;
•
Aerosol, humidification, and therapeutic gas administration;
•
Storage, access, control, administration of medications and medication errors; an
•
Procedures for obtaining and analyzing blood samples (e.g., arterial blood gases).
RC.4 TESTS OUTSIDE THE LABORATORY
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If blood gases or other laboratory tests are performed in the areas other than the lab, including the respiratory care
unit, that area shall meet the applicable requirements for laboratory services as specified in 42 CFR Section 482.27
and LS.1.
Interpretive Guidelines
Refer to the guidelines under 42 C.F.R. Section 482.27 for independent laboratory if blood gases and laboratory tests
are performed in the respiratory care unit.
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MEDICAL IMAGING (MI)
MI.1 ORGANIZATION
SR.1 The organization shall maintain, or have readily available, diagnostic radiology services that meet
professionally approved standards and Federal and State laws for radiation safety and staff
qualifications and requirements according to patient needs. The medical imaging services,
particularly ionizing medical imaging procedures shall be free from hazards for patients and
personnel.
SR.2 If therapeutic services are also provided, they shall meet professionally approved standards and
Federal and State laws for radiation safety and staff qualifications and requirements.
Interpretive Guidelines:
The organization shall maintain, or have readily available, diagnostic radiology services that meet professionally
approved standards and Federal and State laws for radiation safety and staff qualifications and requirements
according to patient needs. The scope and complexity of radiological services offered should be specified in writing
and approved by the medical staff and governing body. These services must be readily available at all times.
Acceptable standards of practice include maintaining compliance with applicable Federal and State laws, regulations
and guidelines governing radiology services, including facility licensure and/or certification requirements, as well as
any standards and recommendations promoted by nationally recognized professional organizations (e.g., the
American Medical Association, American College of Radiology, etc.).
All radiology services provided by the hospital (diagnostic and therapeutic, if offered) must meet acceptable
standards of practice and professionally approved standards for safety and personnel qualifications.
This applies to radiology services that may be provided by the hospital or through a contractual arrangement.
If diagnostic radiology services are provided under a contract arrangement, the services may be provided either on
the hospital premises or in an adjacent or other nearby location. In all circumstances, these services must be readily
accessible to the organization’s facility at all times.
Surveyor Guidance:
Verify that the hospital maintains (or provides in some manner) radiology services that meet the needs of the
patients.
Verify that the radiology services are provided in accordance with accepted standards of practice, and are maintained
or available at all times to meet the patient needs.
If radiology services are provided through a contractual arrangement, verify that the contracted entity adheres to
applicable policies and procedures of the organization and that the contracted entity and its employees or agents are
properly qualified and have an evaluation method in place.
MI.2 RADIATION PROTECTION
SR.1 Proper radiation safety precautions shall be maintained, including adequate shielding for patients,
staff, and facilities, as well as appropriate storage, use, and disposal of radioactive materials.
SR.2 Staff who work in radiation areas shall be monitored continually for the amount of radiation exposure
by the use of exposure meters or badge dosimeters. This includes QLPs who may be exposed to
ionizing radiation during procedures.
SR.3 Any high radiation readings must be investigated and reported to Quality Management Oversight.
Interpretive Guidelines:
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The hospital must develop and implement policies and procedures to provide a safe environment for patients and
staff.
The hospital policies and procedures must address the safety standards for the following:
•
Adequate shielding for patients, personnel and facilities;
•
Labeling of radioactive materials, waste, and hazardous areas;
•
Transportation of radioactive materials between locations within the hospital;
•
Securing radioactive materials, including determining limitations of access to radioactive materials;
•
Testing and maintenance of equipment for prevention of radiation hazards;
•
Maintenance monitoring and measuring devices for equipment;
•
Proper storage of radiation monitoring badges when not in use;
•
Storage and disposal of radio nuclides and radio pharmaceuticals as well as radioactive waste; and,
•
Methods of identifying patients who may be pregnant
•
The hospital must implement and ensure compliance with its established safety standards
•
The hospital shall require any staff member who may be exposed to radiation or working near
radiation sources wear badges to identify levels for amount of radiation exposure. This includes
certain radiology technologists, radiologists, nursing, and maintenance staff.
Surveyor Guidance:
Review locations where radiological services are provided. During this review, assess the following:
Safety measures are implemented for patients and staff;
•
Verify that patient shielding (aprons, etc.) are properly maintained and routinely inspected by the
hospital and review the records for the most recent inspection of the aprons;
•
Review the storage of hazardous materials and process if there is any exposure and the protocol
followed when this occurs;
•
Verify that the hospital requires periodic checks on all radiology personnel and any other hospital staff
exposed to radiation and how the exposure levels are communicated to staff (by month, year, and
cumulative for the staff while in the employ of the hospital – review the records related to these
checks; and,
•
Verify that appropriate staff have a device to detect radiation and that it is worn appropriately without
interference to detect radiation.
•
Verify that hazardous materials are stored properly in a safe manner.
•
Review the organization and functioning of the radiation safety program including policies and systems
used to identify and resolve safety issues.
MI.3 EQUIPMENT
SR.1 Periodic inspection of equipment shall be performed, at least minimally according to manufacturer’s
recommendations. Hazards shall be identified and promptly corrected (See PE.1).
SR.2 Documentation of preventative maintenance and repairs of radiology equipment shall be maintained
(See PE.7).
Interpretive Guidelines:
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The hospital must have policies and procedures in place to ensure that periodic inspections of radiology equipment
are conducted. When these periodic inspections have identified that equipment is not operating or malfunctioning,
this equipment is removed from service and repaired and verified prior to being put into operation for patient care.
The hospital must maintain repair documentation and records for periodic maintenance.
Either the hospital staff or a qualified contract entity must ensure that equipment is inspected in accordance with
manufacturer’s instructions, Federal and State laws, regulations, and guidelines, and hospital policy.
Surveyor Guidance:
Review the records (often maintained in Biomedical/Clinical Engineering) to verify that periodic inspections are
conducted in accordance with manufacturer’s instructions, Federal and State laws, regulations, and guidelines and
hospital policy.
Select the equipment numbers to trace back through the records system to verify calibration and periodic preventive
maintenance performed.
Review the process for detection and correcting identified problems and the timeliness of the response.
MI.4 ORDER
SR.1 Medical imaging services must be provided only on the order of practitioners with clinical privileges
or, consistent with State law, of other practitioners approved by the medical staff and the governing
body and authorized to order the services.
Surveyor Guidance:
Review medical records to determine that radiology services are provided only on the orders of practitioners. The
practitioners ordering radiology services must have these clinical privileges. This also applies to practitioners outside
the hospital who have been authorized by the medical staff and the governing body to order radiology services,
consistent with State law.
MI.5 SUPERVISION
SR.1 A qualified full-time, part-time, or consulting radiologist shall supervise the ionizing radiology
services and shall interpret those radiology tests that are determined by the medical staff to require
a radiologist’s specialized knowledge.
SR.2 For purposes of this standard, a radiologist is a doctor of medicine or osteopathy who is qualified by
education and experience in radiology.
Interpretive Guidelines:
In accordance with this regulation and other Federal and State laws, regulations and guidelines, the medical staff
must approve the qualifications necessary for radiologist appointment to the medical staff.
The hospital must develop and implement policies that have been approved by the medical staff to designate which
radiology tests require interpretation by a radiologist.
In the event that the hospital contracts for telemedicine to be used, including the radiologist who interprets radiology
tests, the hospital has a process in place to verify the radiologist interpreting the radiological test is licensed and/or
meets the other applicable standards that are required by State or local laws in both the State where the practitioner
is located and the State where the patient is located OR is subjected to the credentialing and privileging process
through the medical staff to be approved for providing this service for the hospital.
A radiologist who is a member of the medical staff who supervises these services and includes the following may only
perform radiology services:
•
Monitoring of radiology reports to ensure they are signed by the practitioner who interpreted them;
•
Assigning duties to radiology personnel (duties assigned will only be appropriate to their level of
training, experience, and licensure if applicable);
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•
Assures the enforcement of infection control practices within the radiology setting;
•
Ensures that a process is in place to provide emergency care to patients who experience an adverse
reaction to diagnostic agents in the radiology setting;
•
Ensures the security of files, scans, and other image records and are readily retrievable when needed;
and,
•
Provides for training of radiology staff regarding the safe operation of equipment, performance of
tests offered by the facility and on the management of emergency radiation hazards and accidents.
Surveyor Guidance:
Review the radiologist’s credentialing file to verify that he or she has met the qualifications established by the
medical staff for appointment. If these services are provided by a contracted entity, the survey team will verify that
the hospital has a verification process for those providing these services on behalf of the contracted entity. The
radiologist may be required to go through the medical staff credentialing and privileging process of the hospital.
Review records to determine that a radiologist who interprets those tests has been credentialed and approved by the
medical staff as a qualified radiologist.
Verify that a radiologist who is a member of the medical staff is the physician responsible for the supervision of
radiology services.
MI.6 STAFF
SR.1 Only staff designated as qualified by the medical staff, governing body, and State and/or Federal law
may use the medical imaging equipment and perform medical imaging procedures.
Interpretive Guidelines:
The hospital should maintain appropriate written policies, developed and approved by the medical staff, consistent
with State law, to designate which personnel are qualified to use the radiology equipment and administer
procedures.
Surveyor Guidance:
Review and verify which staff are using various radiological equipment and/or administering patient procedures to
ensure they have been deemed competent to use and perform as needed. This may be done through a sample
review of staff personnel files to determine these individuals meet the qualifications established by the medical staff
for the tasks that are performed.
MI.7 RECORDS
SR.1 Records of medical imaging services must be maintained, in accordance with Nuclear Regulatory
Commission requirements and any other applicable Federal and State law.
MI.8 INTERPRETATION AND RECORDS
SR.1 The radiologist or other practitioner who interprets radiology images and outcomes must sign the
written reports of his/her interpretations.
SR.2 The organization must maintain the following for at least 5 years:
SR.2a copies of reports and print outs; and,
SR.2b films, scans, and other image records.
Interpretive Guidelines:
The hospital must maintain records for all radiology procedures performed in accordance with the Nuclear Regulatory
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Commission. At a minimum, the records should include copies of reports and printouts, and any films, scans or
other image records, as appropriate.
The hospital should have written policies and procedures that ensure the integrity of authentication and protect the
privacy of radiology records. Medical records, which include radiology films, image records, scans, reports, and
printouts must be secure, properly stored, be accessible and retrievable in a timely manner when needed for any
care, procedure, treatment, or test provided or conducted within the past 5 years.
Surveyor Guidance:
Review a sampling of radiology records to verify that reports are signed by the practitioner who reads and evaluates
images or scans.
Review the hospital’s policies, procedures and practices for maintaining radiology records. The documented
procedure for control of records should accurately define these radiology records and the retention, storage and
accessibility of these records. Verify that the hospital maintains radiology records for at least 5 years.
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NUCLEAR MEDICINE SERVICES (NM)
NM.1 ORGANIZATION
SR.1 If the organization provides nuclear medicine services; those services must meet the needs of the
patients in accordance with acceptable standards of practice as defined by the medical staff. The
nuclear medicine services shall be free from hazards for patients and personnel.
SR.2 The organization of the nuclear medicine service shall be appropriate to the scope and complexity of
the services offered.
SR.3 There shall be a director who is a doctor of medicine or osteopathy qualified in nuclear medicine.
SR.4 The qualifications, training, functions, and responsibilities of nuclear medicine staff shall be specified
by the service director and approved by the medical staff.
SR.5 Nuclear medicine services shall be ordered only by practitioners whose scope of Federal or State
licensure and defined staff privileges allow such referrals.
Interpretive Guidelines:
If the hospital provides nuclear medicine services, directly or through a contractual arrangement, they shall be
appropriate to the scope and complexity of services offered to its patients. The services must be in accordance with
acceptable standards of practice as well as any standards and recommendations of nationally recognized professional
organizations that have been defined by the medical staff (e.g., the American Medical Association, American College
of Radiology).
Nuclear medicine services must be under the direction of a doctor of medicine or osteopathy who must be qualified
in nuclear medicine.
The medical staff and physician responsible for nuclear medicine services must define the appropriate qualifications,
training, functions, and responsibilities of nuclear medicine staff.
Nuclear medicine services shall be ordered only by practitioners whose scope of Federal or State licensure and
defined staff privileges allow such orders.
Surveyor Guidance:
Review and validate the type(s) of services provided and the location where these services are provided.
Review and verify that the nuclear medicine service director is an MD/DO and is qualified based upon education,
experience, and specialized training in nuclear medicine, appropriate to the scope and complexity of services offered.
In review of a sampling of personnel files for nuclear medicine staff, verify that they have the appropriate
qualifications, as specified by the medical staff.
Ask if the hospital has had any medical event since the last survey that has been reported to the Nuclear Regulatory
Commission. (NRC requires notification of such an event within one calendar day; the patient and ordering physician
must also be notified).
NM.2 RADIOACTIVE MATERIALS
SR.1 Radioactive materials shall be prepared, labeled, used, transported, stored, and disposed of in
accordance with acceptable standards of practice as defined by the medical staff (See PE.5).
SR.2 The organization must maintain records of the receipt and disposition of radiopharmaceuticals.
SR.3 In-house preparation of radiopharmaceuticals shall be by or under the direct supervision of an
appropriately trained registered pharmacist or doctor of medicine or osteopathy (See MM.1).
SR.4 If laboratory tests are performed in the nuclear medicine service, the service must meet the
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applicable requirements for laboratory services as specified in 42 CFR §482.27.
Interpretive Guidelines:
The hospital shall prepare, label, use, transport, store, and dispose of radioactive materials in accordance with
acceptable standards of practice as defined by the medical staff. The hospital should define through written policies
and procedures practices to include:
•
Handling of equipment and radioactive materials;
•
Protection of patients and personnel from radiation hazards;
•
Labeling of radioactive materials, waste and hazardous areas;
•
Transportation of radioactive materials between locations within the hospital;
•
Security of radioactive materials, including determining who may have access to radioactive materials
and controlling access to radioactive materials;
•
Testing of equipment for radiation hazards;
•
Maintenance of personal radiation monitoring devices;
•
Storage of radionuclides and radiopharmaceuticals as well as radioactive waste; and,
•
Disposal of radionuclides, unused radiopharmaceuticals, and radioactive waste.
Records must be maintained regarding the receipt and disposition of radiopharmaceuticals and have a stated
timeframe for retention of these records in accordance with Federal and State law.
An appropriately trained registered pharmacist or doctor of medicine or osteopathy must oversee the preparation of
radiopharmaceuticals.
If laboratory tests are performed in the nuclear medicine service, the service must meet the applicable requirements
for laboratory services as specified in 42 CFR §482.27.
Surveyor Guidance:
Review and validate that radioactive materials and waste are prepared, labeled, used, transported, stored, and
disposed of in accordance with Federal and State laws and regulations and acceptable standards of practice.
Verify that safety precautions are followed in the functioning of the nuclear medicine service and those personnel
and patients wear appropriate body shielding (e.g., lead aprons or lead gloves) when appropriate.
When radiopharmaceuticals are prepared in-house, verify that the preparation is performed by an appropriately
trained registered pharmacist or doctor of medicine or osteopathy.
Review and verify written policies and procedures to govern the preparation, labeling, use, transporting, storage,
and disposal of radioactive materials in accordance with acceptable standards of practice as defined by the medical
staff.
NM.3 EQUIPMENT AND SUPPLIES
SR.1 Equipment and supplies must be appropriate for the types of nuclear medicine services offered and
must be maintained for safe and efficient performance (See PE.7).
SR.2 The equipment must be maintained in safe operating condition and inspected, tested, and calibrated
at least annually by qualified personnel (See PE.7).
SR.3 Documentation of equipment testing and preventative maintenance shall be maintained (See PE.7).
Interpretive Guidelines:
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The hospital must develop and implement a preventive maintenance process to ensure that nuclear medicine
equipment is maintained in safe operating condition to ensure accurate results and patient, staff, and public safety.
Nuclear medicine equipment must be inspected, tested and calibrated at least annually by qualified personnel in
accordance with Federal and State laws, regulations and guidelines and appropriate documentation (records)
maintained.
Supplies must be appropriate for the types of nuclear medicine services offered and must be maintained for the
safety for the patients, staff, and public.
NM.4 INTERPRETATION
SR.1 The practitioner approved by the medical staff to interpret diagnostic procedures must appropriately
authenticate the interpretation of these tests.
SR.2 The organization must maintain authenticated and dated reports of nuclear medicine interpretations,
consultations, and procedures.
SR.3 The organization must maintain copies of nuclear medicine reports for at least five years.
Interpretive Guidelines:
Only practitioners approved by the medical staff may interpret and sign the interpretation of diagnostic procedures
and tests.
The hospital must maintain records for all nuclear medicine procedures. At a minimum, these records will include
signed and dated reports of nuclear medicine interpretations, consultations, and procedures. This documentation is a
part of the patient’s medical record and must comply with Medical Records Services standards as stated under MR.1
– MR.7. Such records will be retained according the record retention documented procedure, but be no less than five
years.
Surveyor Guidance:
Review and verify that only practitioners approved by the medical staff to interpret diagnostic procedures.
Review and verify that reports of nuclear medicine interpretation, consultations, and procedures are signed and
dated only by practitioners authorized by the medical staff to perform these interpretations.
Verify that copies of nuclear medicine reports are maintained for at least 5 years.
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REHABILITATION SERVICES (RS)
RS.1 ORGANIZATION
SR.1 If the organization provides rehabilitation, physical therapy, occupational therapy, audiology or
speech pathology services, the service(s) shall be provided in a manner that ensures the patient’s
health and safety.
Interpretive Guidelines:
Rehabilitative services (including contractual services) may include physical therapy, occupational therapy, audiology
and speech pathology services.
The hospital will adhere to acceptable standards of practice include compliance with any applicable Federal or State
laws, regulations or guidelines, as well as standards and recommendations promoted by nationally recognized
professional organizations (e.g., American Physical Therapy Association, American Speech and Hearing Association,
American Occupational Therapy Association, American College of Physicians, American Medical Association).
Surveyor Guidance:
Review the extent of rehabilitation services and if these services are provided directly by the hospital or through a
contractual arrangement.
Validate that these services are provided in a manner that ensures the patient’s health and safety. Verify that
rehabilitation services are integrated into the hospital’s QMS oversight.
RS.2 MANAGEMENT AND SUPPORT
SR.1 The organization shall ensure that there is the appropriate management and support for this core
process. These requirements shall include:
SR.1a A director/manager who has the responsibility for the management, direction and
accountability for ensuring services are carried throughout the organization;
SR.1b The director/manager shall have the qualifications, experience and/or training defined by the
organization and appropriate for this position (See SM.2);
SR.1c Staff who meet the qualifications as defined by the medical staff and organization and
consistent with State law shall be performed by qualified physical therapists, physical
therapists assistants, occupational therapists, occupational therapist assistants, speech-
language pathologists, or audiologists (as defined in 42 CFR §484.4 Personnel qualifications;
see SM.1, SM.2).
Interpretive Guidelines:
The hospital must manage and support the service(s) as necessary to maintain the level provided. In order to
support these services, the appropriate equipment and qualified personnel must be in place and follow acceptable
standards of practice.
The rehabilitation services offered must be under the direction of a qualified individual that will have the
accountability, qualifications, and experience appropriate for this position. The staff (employed or contracted) shall
meet the required qualifications, as defined by the organization to provide these services.
Surveyor Guidance:
Review the hospital’s policies and procedures to verify that the scope of rehabilitation services offered is defined in
writing and that these services are under the direction of a qualified individual.
Verify that staff providing rehabilitative services meet the qualifications, as defined by the medical staff and the
organization and are consistent with State law and shall be performed by qualified physical therapists, physical
therapist assistants, occupational therapists, occupational therapist assistants, speech-language pathologists, or
audiologists. (As defined in 42 CFR § 484.4 Personnel qualifications.)
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If services are provided under a contractual arrangement, determine that the agreement requires the staff to be
appropriately qualified (as listed above) and scope of services provided.
Sample personnel files to verify current licensure, certifications and ongoing training, consistent with applicable State
laws.
RS.3 TREATMENT PLAN/ORDERS
SR.1 Rehabilitative services shall only be provided under the orders of a qualified and licensed practitioner
who is responsible for the care of the patient, acting within his or her scope of practice under State
law, and has been authorized by the hospital’s medical staff to order these services in accordance
with the hospital’s policies and procedures and State laws.
SR.2 All orders for rehabilitative services, treatment plan, results, and notes must be documented in the
patient’s medical record in accordance with the requirements defined under the Medical Records
(MR) chapter of these accreditation requirements.
Interpretive Guidelines:
The hospital shall have an individualized plan of care, based on the patient’s specific rehabilitation needs, input from
family/caregivers and therapeutic treatment goals for the patient that are documented in the patient’s record prior to
the initiation of treatment. At a minimum, this treatment plan will include:
•
The order from the practitioner for the service(s) in collaboration with individuals qualified to provide
the service(s);
•
The type, amount, frequency and duration of services;
•
Diagnosis and anticipated goals, results and notes; and,
•
Reviews and revisions, as necessary, to account for changes in the patient’s condition and or response
to therapeutic intervention.
Surveyor Guidance:
Sample patient records to verify that rehabilitation services are provided only in accordance with practitioner orders
who are authorized by the medical staff to order these services and that those orders are documented in the medical
record.
In the review of patient records, verify that there is a plan of care established in writing prior to the beginning of
treatment and there are stated anticipated goals for the patient.
Verify that changes in the treatment plan are documented in the patient’s medical record to include the evaluation,
test results, or orders, and practitioner approvals of changes.
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EMERGENCY DEPARTMENT (ED)
ED.1 ORGANIZATION
SR.1 The organization must meet the emergency needs of its patients in accordance with acceptable
standards of practice.
SR.2 Emergency Services shall be organized and integrated with other departments under the direction
and supervision of a qualified member of the medical staff.
SR.3 The medical staff shall be responsible for developing and maintaining policies and procedures
governing the medical care delivered.
Interpretive Guidelines:
The hospital’s emergency services must be integrated with the other departments of the hospital (e.g. surgical
services, laboratory, ICU, diagnostic services) and be accessible in the delivery of emergency care for patients.
The emergency department will be under the direction of a qualified member of the medical staff.
The medical staff will define the criteria that include the qualifications for the director of emergency service in
accordance with Federal and State law.
The medical staff will ensure that policies and procedures are developed and implemented to govern the emergency
services provided.
Hospitals have the responsibility and must abide by the Emergency Treatment and Labor Act (EMTALA). It is
intended to reinforce that the EMTALA responsibility of the hospital with a dedicated emergency department begins
when an individual arrives on hospital property (ambulance arrival) and not when the hospital “accepts” the
individual from the gurney. An individual is considered to have “presented” to the hospital when her or she arrives
at the hospital’s dedicated emergency department or on hospital property and a request is made by the individual or
on his or her behalf for examination or treatment of an emergency medical condition (42 CFR 489.24(b)). Once an
individual comes to the emergency department of the hospital, whether by EMS or otherwise, the hospital has the
obligation to provide an appropriate medical screening examination and, if an emergency medical condition is
determined to exist, provide any necessary stabilizing treatment or an appropriate transfer. Failure to meet these
requirements constitutes a potential violation of EMTALA.
EMTALA obligations would also apply to the hospital that has accepted transfer of a patient from another facility, as
long as it is an “appropriate transfer” under EMTALA. An appropriate transfer is one in which the transferring hospital
provides medical treatment that minimizes risks to an individual’s health and the receiving hospital has the capability
and capacity to accept the patient at the time the transfer is effectuated. A hospital that delays the
medical screening examination or stabilizing treatment of a patient, who arrives via transfer from another facility, by
not allowing EMS to leave the patient, could also be in violation of EMTALA.
A hospital policy or practice that relies on calling 9-1-1 in order for EMS to substitute its emergency response
capabilities for when the hospital is required to maintain as stated above. The hospital may not rely on 9-1-1 to
provide appraisal and initial treatment of medical emergencies that occur at the hospital.
Surveyor Guidance:
Verify that emergency services are organized under the direction of a qualified member of the medical staff.
Review and validate policies and procedures (including triage of patients) and that they are evaluated and updated
on an ongoing basis.
Review and validate the coordination and communication between the Emergency Department and other hospital
services/departments (e.g. laboratory, diagnostic services, surgical services).
Verify that the hospital is in compliance with EMTALA and has such policies, procedures and appropriate resources in
place to ensure effective compliance with EMTALA in accordance with the emergency services provided.
ED.2 STAFFING
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SR.1 Adequate medical and nursing staff qualified in emergency care, as outlined in the written scope of
service, must be present to meet the written emergency procedures and needs determined by the
organization.
SR.2 A qualified registered nurse shall perform patient triage upon presentation to the emergency
department.
Interpretive Guidelines:
The hospital must ensure that a qualified member of the medical staff is on premises and available to supervise the
provision of emergency services at all times.
The hospital shall also provide nursing staff qualified in emergency care, as outlined in the written scope of service,
to be present when emergency services are provided.
The hospital must staff the emergency department with the appropriate numbers and types of professionals and
other staff who possess the skills, education, certifications, specialized training and experience in emergency care
when emergency services are provided.
The hospital must work with Federal, State and local agencies and officials in order to identify risks to the community
(e.g., natural disasters, mass casualties, terrorist acts), to anticipate demands and resources needed by the hospital
emergency services, and accordingly, develop plans and methods to address and coordinate anticipated needs.
Surveyor Guidance:
Verify that a qualified member of the medical staff is on premises and available to supervise the provision of
emergency services at all times.
Verify that the appropriate numbers and types of professionals and other staff who possess the skills, education,
certifications, specialized training and experience in emergency care when emergency services are provided.
Review and validate the processes in place to demonstrate that the hospital works with Federal, State and local
agencies and officials in order to identify risks to the community to anticipate demands and resources needed by the
hospital emergency services.
ED.3 EMERGENCY SERVICES NOT PROVIDED
SR.1 If emergency services are not provided at the organization, the governing body must assure that the
medical staff has written policies and procedures for appraisal of emergencies, initial treatment, and
referral when appropriate.
Interpretive Guidelines:
This requirement applies hospital-wide (on-campus and off-campus locations) that do not provide emergency
services.
The governing body must assure that the medical staff has written policies and procedures for appraisal of
emergencies, initial treatment, and referral when appropriate.
The hospital must have appropriate policies and procedures in place for dealing with emergency care situations at
the hospital. This includes emergencies that occur to hospital patients, staff, visitors, and others at any hospital
location and to individuals who come to the hospital or any of its off-campus locations seeking/requiring emergency
care.
Surveyor Guidance:
Review and verify that the medical staff has implemented written policies and procedures for the management of
medical emergencies.
Interview staff to ensure they are aware of the policies and procedures for managing medical emergencies.
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Discuss with staff their role and responsibilities if such an emergency is encountered how they will respond and
determine if this is consistent with the policies and procedures in place.
Review and validate that emergency care policies and procedures address both on-campus and off-campus locations.
ED.4 OFF-CAMPUS DEPARTMENTS
SR.1 The medical staff shall have written policies and procedures for appraising and referring emergencies
that occur in off-campus departments where emergency services are not provided.
Interpretive Guidelines:
This requirement applies to off-campus departments that do not provide emergency services.
The hospital will implement written policies and procedures for appraising and referring emergencies that occur in
off-campus departments. This includes emergencies involving patients, staff, visitors, or others or individuals who
come to those locations seeking/requiring emergency care.
Initial treatment and stabilization of patients requiring emergency care must be provided within the capabilities and
complexities of services provided and the staff on-site at these off-campus departments.
Surveyor Guidance:
Review and validate that written policies and procedures address the appraisal and referral of medical emergencies
that occur in off-campus departments. As appropriate, when visiting the off-campus departments, validate that the
staff are aware of these policies and procedures.
Interview staff to ensure they are aware of the policies and procedures for managing medical emergencies.
Discuss with staff their role and responsibilities if such an emergency is encountered how they will respond and
determine if this is consistent with the policies and procedures in place.
Note: In many cases, staff will state they call 9-1-1, but the staff at these sites cannot rely upon 9-1-1 to provide
appraisal and initial treatment. Discuss how the staff would handle such an emergency to ensure the staff are aware
of the policies and procedures to follow if they were to encounter such an emergency.
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OUTPATIENT SERVICES (OS)
OS.1 ORGANIZATION
SR.1 If the organization provides outpatient services, the services shall be appropriately organized and
integrated with inpatient services.
Interpretive Guidelines
If the hospital provides outpatient care to its patients, these services shall be organized and integrated with inpatient
services, as appropriate.
The organization of the hospital’s outpatient services must be appropriate to the scope and complexity of services
offered.
All outpatient services provided by the hospital must meet the needs of the patients, in accordance with acceptable
standards of practice. The hospital must ensure that services, equipment, staff, and infrastructure are adequate to
provide the outpatient services offered at each location in accordance with acceptable standards of practice.
Outpatient services must be integrated into the hospital’s QMS oversight.
Surveyor Guidance:
Verify the extent of outpatient services provided; and,
Verify that the outpatient services are organized in a manner appropriate to the scope and complexity of services
offered.
Review medical records of outpatients who were later admitted to the hospital in order to determine that pertinent
information from the outpatient record has been included in the inpatient record.
Verify that outpatient services are integrated into the hospital’s QMS oversight.
OS.2 STAFFING
SR.1 The organization shall assign one or more individuals to be responsible for outpatient services.
SR.2 Have appropriate professional and non-professional personnel available at each location where
outpatient services are offered, based on the scope and complexity of outpatient services.
OS.3 SCOPE OF SERVICE
A documented scope of service shall be available for each patient care site that includes core staffing for each site
with associated staff responsibilities.
Interpretive Guidelines:
The hospital must designate one or more individuals responsible for the overall operation of the hospital’s entire
outpatient services (all outpatient services). The hospital should define in writing the qualifications and competencies
necessary to direct the outpatient services.
Adequate types and numbers of qualified professional and nonprofessional personnel must be available to provide
patients with the appropriate level of care and services.
Surveyor Guidance:
Verify that the hospital has designated one or more appropriately qualified individuals to manage and be responsible
for outpatient services.
Review and validate the application of policies and contracts, if services provided are under an arrangement. Review
the scope of services for patient care and document core staffing for each area.
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OS.4 ORDERS
Orders for outpatient services must be ordered by a practitioner who meets the following conditions:
SR.1 Is responsible for the care of the patient.
SR.2 Is licensed in the State where he or she provides care to the patient.
SR.3 Is acting within his or her scope of practice under State law.
SR.4 Is authorized in accordance with State law and policies adopted by the medical staff, and approved
by the governing body, to order the applicable outpatient services. This applies to the following:
SR.4a All practitioners who are appointed to the hospital's medical staff and who have been granted
privileges to order the applicable outpatient services.
SR.4b All practitioners not appointed to the medical staff, but who satisfy the above criteria for
authorization by the medical staff and the hospital for ordering the applicable outpatient
services for their patients.
Interpretive Guidelines:
Orders for outpatient services may be made by any practitioner who is:
• Responsible for the care of the patient;
• Licensed in, or holds a license recognized in, the jurisdiction where he/she provides care to the patient;
• Acting within his/her scope of practice under State law; and
• Authorized by the medical staff to order the applicable outpatient services under a written hospital policy that
is approved by the governing body. This includes both practitioners who are on the hospital medical staff and who
hold medical staff privileges that include ordering the services, as well as other practitioners who are not on the
hospital medical staff, but who satisfy the hospital’s policies for ordering applicable outpatient services.
This regulation allows hospitals to accept orders for outpatient services both from practitioners who hold hospital
privileges as well as practitioners who do not, including those who are not located in the hospital’s close geographic
area.
It is not uncommon for individuals to obtain health care services in a variety of locations from a variety of
practitioners. Sometimes an individual elects to seek services from a specialist in a tertiary setting removed from the
area where the individual lives, but prefers to get follow-up care, such as physical therapy after a surgery, closer to
home.
Sometimes an individual may have multiple residences in different areas and may need to continue care locally when
moving between residences. Sometimes individuals receive urgent or even emergent care while traveling. Accepting
orders and referrals for outpatient services from practitioners not on the medical staff or not holding privileges
enables a hospital to promotes ready access to care for patients in the area it serves.
Finally, sometimes a practitioner who does not practice in a local hospital may nevertheless refer patients to that
hospital for outpatient services, such as diagnostic imaging, physical and occupational therapy, etc.
The authority to write orders for outpatient services is covered under the hospital’s medical staff privileging process
for members of the hospital’s medical staff and for practitioners who have been granted privileges by the hospital
without being appointment to the medical staff.
For practitioners who do not hold hospital privileges the hospital’s medical staff policy may permit them to refer
patients to the hospital with orders for specific outpatient services so long as all of the above criteria are met. The
policy must address how the
hospital verifies the referring/ordering practitioner is appropriately licensed and acting within his/her scope of
practice. The regulation does not prescribe the details of the licensure and scope of practice verification process but
instead provides a hospital the flexibility to accomplish this in the manner it finds efficient and effective. The hospital
is expected to ensure the verification process is followed for all outpatient services in all hospital locations.
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The policy must also make clear whether the policy applies to all hospital outpatient services, or whether there are
specific services for which orders may only be accepted from practitioners with medical staff privileges. For example,
a hospital may prefer not to accept orders for a regimen of outpatient chemotherapy or outpatient therapeutic
nuclear medicine services from a referring physician who does not hold medical staff privileges. In such cases, the
hospital’s policy must make these exceptions clear to the general authorization for accepting orders from referring
practitioners.
Surveyor Guidance:
Survey a variety of settings that offer outpatient services. Ask department staff whether orders or referrals for that
type of outpatient service are accepted from practitioners who do not hold hospital privileges. If yes:
• Ask for evidence that the medical staff has adopted the policy.
• Ask how the hospital verifies that the order or referral comes from a referring practitioner who is
appropriately licensed in the jurisdiction where he/she provides care to the patient and is practicing
within his/her scope of practice under State law to prescribe such orders. Ask for documentation of
such verification efforts.
• Ensure the same verification process is followed consistently in all outpatient settings.
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DIETARY SERVICES (DS)
DS.1 ORGANIZATION
SR.1 Dietary Services are organized processes that shall be carried out internally or through a contract
with a nutrition management company that interacts on a regular basis with the medical staff on
dietetic policies affecting patient care.
SR.2 The organization shall ensure that there is the appropriate management and support for this core
process. These requirements shall include a full-time person responsible for the management,
direction and accountability for ensuring food and dietetic services are carried out daily throughout
the organization. This full-time person shall have the qualifications, experience and training defined
by the organization and appropriate for the position.
SR.3 The full-time person responsible for the management of Food and Dietetic Services shall ensure that
the appropriate administrative and technical personnel are competent and adequate to carry out this
process for the organization.
SR.4 The organization shall have a qualified dietitian in the organization that is available to address
issues, concerns, and patient care planning. This dietitian shall be employed by the organization on a
full-time or part-time basis or contracted as a consultant for the organization and available as
needed.
Interpretive Guidelines:
The nutritional needs of the patients are met in accordance with practitioners’ orders, acceptable standards of
practice, and the hospital being in compliance with Federal and State licensure requirements for food and dietary
personnel as well as food service standards, laws and regulations. These activities are carried out by food and
dietetic services. This can be completed with qualified hospital staff or through a contractual basis with a nutrition
management company.
The full-time individual responsible for dietary services will be authorized and have the delegated responsibility for
these services from the hospital’s governing body and medical staff. The responsibilities of the responsible individual
in this role will include operational management, implementing training and education for dietary staff, and assuring
that there are policies and procedures developed and implemented to address at least the following:
•
Orientation, work assignments, supervision of work and personnel performance;
•
Safety practices for food handling;
•
Provision for emergency food supplies; and,
•
Supervision of the menu planning function, purchasing of foods and supplies, and retention of
required records.
The hospital should have written policies and procedures that address at least the following:
•
Availability of a diet manual and therapeutic diet menus to meet patients’ nutritional needs;
•
Frequency of meals served;
•
Process for ordering and delivery of food to respective patient areas;
•
Accommodation of non-routine occurrences (e.g., parenteral nutrition (tube feeding), total parenteral
nutrition, peripheral parenteral nutrition, change in diet orders, early/late trays, nutritional
supplements, etc.);
•
Guidelines for acceptable hygiene practices of dietary personnel and the sanitation protocols for the
preparation and cleaning areas; and,
•
Integration of the dietary service into the organization-wide quality management oversight and
Infection Control programs.
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The full-time individual responsible for dietary services must demonstrate he or she has the qualifications necessary
to manage the service to include education, experience, and/or training appropriate to the scope and complexity of
the dietary operations.
The hospital must have a qualified dietitian to supervise the nutritional aspects of patient care. This individual shall
have met the required education, experience, and training defined by the hospital and medical staff, and, where
applicable, the State licensure or registration when applicable.
The qualified dietitian will be responsible for:
•
Approving menus and nutritional supplements provided to patients;
•
Providing dietary counseling to patients and those responsible for the patient upon discharge;
•
Performing and documenting nutritional assessments;
•
Evaluating patient tolerance to therapeutic diets as appropriate;
•
Collaborating with other hospital services (e.g., medical staff, nursing services, pharmacy service,
social work service, etc.) to plan and implement patient care as necessary to meet the nutritional
needs of the patients;
•
Maintaining pertinent patient data necessary to recommend, prescribe, and/or modify therapeutic
diets as needed to meet the nutritional needs of the patients; and,
•
Maintaining professional standards of practice.
If the qualified dietitian does not work full-time, and when the dietitian is not available, the hospital must make
adequate provisions for dietary consultation that meets the needs of the patients.
Surveyor Guidance:
Verify that the director of dietary services is a full-time employee and has an appropriate job description to verify
that his or her responsibility and authority for the direction of the dietary service has been clearly delineated. The
personnel file for this individual should be reviewed.
Review the dietitian’s personnel file to determine that he or she is qualified for this role and has an appropriate job
description to verify he or she has the experience, specialized training, and required licensure or certification (as
required by State law).
If the dietitian is not full-time, determine the frequency in which the nutritional needs of the patients are assessed,
and that the hospital makes adequate provisions for qualified consultant coverage when this dietitian is not available.
This would include evening and weekend coverage.
DS.2 SERVICES AND DIETS
Dietary Services shall be provided and menus/diets offered that meet the needs of the patients in accordance with
recognized dietary practices. The following criteria shall be applied:
SR.1 All menus/diets offered must meet the needs of the patients
SR.2 All therapeutic diets shall be prescribed by a practitioner or practitioners responsible for the care of
the patient; OR by a qualified dietitian or qualified nutritional professional when permitted under
State law and when granted such privileges by the medical staff.
SR.3 All nutritional needs of patients shall be met in accordance with recognized dietary practices that are
consistent with the orders of the practitioner or practitioners responsible for the care of the patients.
Interpretive Guidelines:
Menus provided by the hospital must be nutritionally balanced and meet the special needs of the patients. Current
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menus available to patients will be posted or readily available in the food preparation area.
Review the screening criteria to identify patients at nutritional risk and how the process is carried out from
assessment and re-assessment to ensure that their nutritional needs are being met.
The following represent examples of patients who require nutritional assessment. The organization may define
additional criteria for the provision of nutritional assessments:
•
All patients requiring artificial nutrition by any means (i.e., parenteral nutrition (tube feeding), total
parenteral nutrition, or peripheral parenteral nutrition);
•
Patients whose medical condition or physical status (current or future status based upon care plan)
interferes with their ability to ingest, digest or absorb nutrients;
•
Patients whose diagnosis or presenting signs/symptoms indicates a compromised nutritional status
(e.g., anorexia nervosa, bulimia, electrolyte imbalances, dysphagia, mal-absorption, end stage
organ diseases, etc.); and,
•
Patients whose medical condition is directly impacted by their nutritional intake (e.g., diabetes,
congestive heart failure, food/drug interactions, etc.).
For all therapeutic diets provided to patients as a result of a nutritional assessment or as prescribed, such diets
should be:
•
Prescribed in writing by a qualified practitioner, a qualified dietitian, or qualified nutritional
professional;
•
Documented in the patient’s medical record (include the patient’s tolerance to the diet); and,
•
Evaluated for nutritional adequacy to meet the patient’s needs.
In the event a patient refuses the food served, the patient should be offered an appropriate substitute that is of
equal nutritional value in order to meet their nutritional needs. Religious beliefs should also be taken into
consideration if applicable.
Current national standards for recommended dietary allowances will be referenced (i.e., the current Recommended
Dietary Allowances (RDA) or the Dietary Reference Intake (DRI) of the Food and Nutrition Board of the National
Research Council).
Surveyor Guidance:
Review medical records to verify where therapeutic diet orders are prescribed and authenticated by the
practitioner(s) responsible for the care of the patient. In the sampling of medical records reviewed, verify that:
•
The patient’s nutritional needs have been met;
•
The appropriate therapeutic diets have been ordered; and,
•
The patient’s dietary intake and nutritional status is being monitored and re-assessed as appropriate.
•
If diets are being prescribed/ordered by a qualified dietitian or qualified nutritional professional, verify
that such person has been granted that authority by the medical staff and state law permits this
practice.
The hospital should be able to demonstrate what national standard they are following to be applied to their menus to
meet the nutritional needs of their patients.
DS.3 DIET MANUAL
SR.1 The organization shall maintain a dietary manual (hardcopy or electronic) that defines the current
therapeutic diets used by the organization.
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SR.2 The dietary manual shall be approved by a dietitian (full-time, part-time or contracted) and the
medical staff at least every five years.
SR.3 The dietary manual shall be a document that is communicated, controlled and available to all staff
and practitioners who are directly or indirectly responsible for ensuring that appropriate nutritional
services are implemented.
Interpretive Guidelines:
A therapeutic diet manual must be approved by the dietitian and the medical staff. This therapeutic diet manual
should be reviewed and under no circumstance should the publication or revision date be more than five years old.
The therapeutic diet manual must be readily available to all medical, nursing and food service personnel.
Surveyor Guidance:
Review the therapeutic diet manual to determine that it is current and readily available to all appropriate staff. The
therapeutic diet manual should include the diets currently available to patients and meet current national standards,
such as RDA or DRI. The therapeutic diet manual should be referenced as necessary when such diets are prescribed.
Verify that the therapeutic diet manual has been approved by the medical staff and a qualified dietitian.
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PATIENT RIGHTS (PR)
PR.1 NONDISCRIMINATION
SR.1 The organization will comply with the nondiscrimination provisions of Section 1557 of the Affordable
Care Act (ACA), and will not deny access to health care because of race, color, national origin, sex,
age, or disability.
SR.2 The organization will recognize all state-sanctioned marriages and spouses for purposes of
compliance with the Conditions of Participation, regardless of any laws to the contrary of the state or
locality where the organization is located.
Interpretive Guidelines:
In compliance with Section 1557 of the Affordable Care Act:
The hospital will post information notifying patients about their rights
The hospital will post information notifying patients with limited English proficiency (LEP) about the right to receive
communication assistance.
• The hospital is also required to post taglines in the top 15 languages spoken by individuals with LEP
in the states in which the covered entity operates, advising consumers of the availability of free
language assistance services.
Except where CMS regulations explicitly require an interpretation in accordance with State law, wherever the text of
a regulation or associated guidance uses the terms “marriage” or “spouse” or includes a reference to a patient’s
“representative,” “surrogate,” “support person,” “next-of-kin,” or similar term in such a manner as would normally
implicitly or explicitly include a spouse, the terms are to be interpreted consistent with the guidance noted below:
“spouse” means an individual who is married to another individual as a result of marriage lawful where it was
entered into, including a lawful same-sex marriage, regardless of whether the jurisdiction where the
hospital is located, or in which the spouse lives, permits such marriages to occur or recognizes such
marriages.
“marriage” means a marriage lawful where entered into, including a lawful same-sex marriage, regardless of
whether the jurisdiction where the hospital is located, or in which the spouse lives, permits such
marriages to occur or recognizes such marriages;
“family” includes, but is not limited to, an individual’s “spouse” (see above); and
“relative” when used as a noun, includes, but is not limited to, an individual’s “spouse” (see above).
PR.2 SPECIFIC RIGHTS
The organization shall protect and promote each patient’s rights. The organization shall inform, whenever possible,
each patient and/or legal representative of the patient’s rights in advance of providing or discontinuing care. The
written listing of these rights shall be provided to the patient and /or family and shall include policies and procedures
that address the following:
SR.1 Beneficiary Notices:
SR.1a Of non-coverage and right to appeal premature discharge; and,
SR.1b Medicare Outpatient Observation Notice (MOON).
SR.2 Patient participation and means for making informed decisions regarding his/her plan of care;
SR.3 Information to the patient or family of patient care and to involve the patient and family to make
informed decisions regarding their care planning and treatment, including the requesting and/or
refusing treatment, their health status, not to be construed as a demand for the provision of
treatment or services deemed medically unnecessary or inappropriate;
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SR.4 Prompt notification of the patient and his/her representative of patient choice and to promptly notify
the patient’s physician of admission;
SR.5 Personal privacy;
SR.6 Provision of care in a safe setting;
SR.7 Freedom from all forms of abuse or harassment;
SR.8 Confidentiality of clinical records;
SR.9 Patient access to clinical records as quickly as record keeping system permits; and,
SR.9(a) The hospital must not impede the legitimate efforts of individuals to gain access to their own
clinical records and must actively seek to meet these requests as quickly as the record
keeping system permits.
SR.10 Procedure for submission of a written or verbal grievance. (See PR.5 Grievance Procedure)
SR.11 Pain Management
SR.12 Patient visitation rights
SR.12(a) The hospital must have written policies and procedures regarding the visitation rights of
patients, including those setting forth any clinically necessary or reasonable restriction or
limitation that the hospital may need to place on such rights and the reasons for the clinical
restriction or limitation.
SR.12(b) The hospital must: Inform each patient (or representative, where appropriate) of his or her
visitation rights, including any clinical restriction or limitation on such rights, when he or she
is informed of his or her other rights under 42 CFR Section 482.13(a).
SR.12(c) Inform each patient (or representative, where appropriate) of the right, subject to his or her
consent, to receive the visitors whom he or she designates, including, but not limited to, a
spouse, a domestic partner (including a same-sex domestic partner), another family
member, or a friend, and his or her right to withdraw or deny such consent at any time.
SR.12(d) Not restrict, limit, or otherwise deny visitation privileges on the basis of race, color, national
origin, religion, sex, sexual orientation, gender identity, or disability.
SR.12(e) Ensure that all visitors designated by the patient (or representative, where appropriate)
enjoy visitation privileges that are no more restrictive than those that immediate family
members would enjoy.
SR.13 Other rights defined within the Patient Rights requirements (PR.1 – PR.8)
Interpretive Guidelines:
This standard requires that whenever possible, the hospital informs each patient and/or legal representative of the
patient’s rights in advance of providing or discontinuing care. The hospital will inform both inpatients and outpatients
of their rights to include the elements as described in PR.1, SR.1 – SR.10.
The MOON is a standardized notice to inform beneficiaries (including Medicare health plan enrollees) that they are an
outpatient receiving observation services and are not an inpatient of the hospital.
The MOON is mandated by the Federal Notice of Observation Treatment and Implication for Care Eligibility Act
(NOTICE Act), passed on August 6, 2015. The NOTICE Act requires all hospitals to provide written and oral
notification under specified guidelines.
All organizations are required to provide the MOON beginning no later than March 8, 2017.
https://www.cms.gov/Medicare/Medicare-General-Information/BNI/index.html?redirect=/bni/
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Each Medicare beneficiary who is an inpatient is provided with a standardized notice, the “Important Message from
Medicare, within two days of their admission. The Important Message (IM) template provided by CMS is to be used
by the hospital, signed and dated by the patient when it is delivered to the beneficiary. In addition a copy of the IM
is to be presented to the beneficiary within two days before discharge.
The hospital has the responsibility to establish and implement policies and procedures that effectively ensure that
patients and/or legal representative have the information necessary to exercise their rights under the Federal law.
This responsibility includes, and is not limited to, providing all notices required by statute and regulation regarding
patients’ rights. The hospital may decide it is most effective to bundle the patients’ rights and advance directives
notice with these existing notices.
The hospital will provide for interpretation for certain individuals who speak languages other than English, use
alternative communication techniques or aides for those who are deaf or blind, or take other steps as needed to
effectively communicate with the patient.
The hospital’s obligation to inform requires that the hospital present information in a manner and form that can be
understood (e.g., the use of large print materials, specialized programs to inform individuals who are deaf or blind,
use of interpreters).
The hospital must include the patient or their legal representative in the development, implementation and revision
of his/her plan of care.
A patient may elect to delegate his or her right to make informed decisions to another person. To the degree
permitted by State law, and to the maximum extent practical, the hospital must respect the patient’s wishes and
follow these accordingly. If the patient is unconscious or otherwise incapacitated and unable to make a decision, the
hospital must consult the patient’s advance directives, medical durable power of attorney or patient representative, if
any of these individuals are available. In the advance directive or the medical power of attorney, the patient may
provide guidance as to his or her wishes in certain situations, or may delegate decision-making to another individual
as permitted by State law. If such an individual has been selected by the patient, or if a person willing and able
under applicable State law is available to make treatment decisions, relevant information should be provided to the
representative so that informed health care decisions can be made for the patient. However, as soon as the patient
is able to be informed of his or her rights, the hospital should provide such information to the patient.
The patient’s (or patient’s representatives, as allowed by law) right to participate in the development and
implementation of his or her plan of care includes at a minimum, the right to: information regarding the patient’s
health status, diagnosis and prognosis, participate in the development and implementation of his/her inpatient
treatment/care plan or outpatient treatment/care plan, including providing consent to, or refusal of, medical or
surgical interventions,; participate in the development and implementation of his/her discharge plan; and,
participate in the development and implementation of his/her pain management plan. The patient or his or her
representative should receive information provided in a manner that it is understood and to assure that the patient
can effectively exercise the right to make informed decisions.
The patient and/or legal representative has the right to request or refuse treatment. This standard stresses,
however, that the patient’s right to make decisions about health care is not equivalent to an ability to demand
treatment or services that are deemed medically inappropriate or unnecessary.
The right to personal privacy includes, at a minimum, that patients have privacy during personal hygiene activities
(e.g., toileting, bathing, dressing), during medical/nursing treatments, and when requested by the patient as
appropriate. The right to personal privacy would also include limiting the release or disclosure of patient information
such as the patient’s presence in the facility or location in the hospital, or personal information such as name, age,
address, income, health information without prior consent from the patient. The hospital should have procedures in
place, in accordance with State law, to provide appropriate information to patient families or significant others in
those situations where the patient is unable to make their wishes known.
If an individual requires assistance during toileting, bathing, and other personal hygiene activities, staff should
assist, giving utmost attention to the individual’s need for privacy. Privacy should be afforded when the MD/DO or
other staff visits the patient to discuss clinical care issues or conduct any examination.
A patient’s right to privacy may be limited in situations where a person must be continuously observed, such as
when restrained or in seclusion when immediate and serious risk to harm him/ herself (such as when the patient is
under suicide precautions or special observation status) or others exists.
The hospital staff should follow current standards of practice for patient environmental safety, infection control, and
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security. The hospital must protect vulnerable patients, including newborns and children.
The hospital must ensure that patients are free from all forms of abuse, neglect, or harassment. The hospital must
have mechanisms/methods in place that ensure patients are free of all forms of abuse, neglect, or harassment.
The hospital must assure that any incidents of abuse, neglect or harassment are reported and analyzed, and the
appropriate corrective, remedial or disciplinary action occurs, in accordance with applicable local, State, or Federal
law.
Definition: Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment,
with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury
or intimidation of one patient by another. Neglect, for the purpose of this requirement, is considered a form of
abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish,
or mental illness.
The hospital must have sufficient safeguards in place to ensure that access to all information regarding patients is
limited to those individuals designated by law, regulation, and policy; or duly authorized as having a need to know.
No unauthorized access or dissemination of clinical records is permitted. Clinical records are kept secure and are only
viewed when necessary by those persons having a part in the patient’s care.
Confidentiality applies to both central records and clinical record information that may be kept at other locations in
the hospital, such as, patient units, radiology, laboratories, patient clinics, record storage areas, data systems, etc.
Patient visitation rights:
The hospital must have developed written policies and procedures regarding the visitation rights of patients,
including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital may need
to place on such rights and the reasons for the clinical restriction or limitation.
A hospital must (1) Inform each patient (or representative, where appropriate) of his or her visitation rights,
including any clinical restriction or limitation on such rights, when he or she is informed of his or her other rights
under 42 CFR 482.13(a). (2) Inform each patient (or representative, where appropriate) of the right, subject to his
or her consent, to receive the visitors whom he or she designates, including, but not limited to, a spouse, a domestic
partner (including a same-sex domestic partner), another family member, or a friend, and his or her right to
withdraw or deny such consent at any time. (3) Not restrict, limit, or otherwise deny visitation privileges on the basis
of race, color, national origin, religion, sex, sexual orientation, gender identity, or disability. (4) Ensure that all
visitors designated by the patient (or representative, where appropriate) enjoy visitation privileges that are no more
restrictive than those that immediate family members would enjoy.
Surveyor Guidance:
Verify the hospital’s policy for notifying all patients of their rights, both inpatient and outpatient.
Review the information that is provided to patients by the hospital. Verify the method(s) used to inform patients of
their rights.
Interview patients (with hospital and patient permission) to determine how the hospital has informed them about
their rights.
Verify that the hospital has alternative means, such as written materials, signs, or interpreters, to communicate
patients’ rights, when necessary.
Validate that the hospital initiates activities that involve the patient or the patient’s legal representative in the
patient’s care and the process for assuring that the patients have this information.
Verify that the hospital respects a patient’s request for or refusal of certain treatments and the process followed
when this occurs and how this is handled.
Verify that there is a policy that addresses how patient requests for treatment are handled and the circumstances
under which a patient request for treatment may be denied.
Verify that the hospital provides adequate information to patients and their representatives regarding the patient’s
health status, diagnosis and prognosis, and then how the patient is allowed to make informed decisions about their
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care planning and treatment.
Review and verify that the hospital has a system in place to assure that a patient’s family and MD/DO are contacted
as soon as can be reasonably expected after the patient is admitted (unless the patient requests that this not be
done).
In the review of patient care areas, verify that patients are provided privacy during examinations, procedures,
treatments, surgery, personal hygiene activities, and discussions about their health status/care and other
appropriate situations.
Review and validate patient and staff incident and accident reports to identify any incidents or patterns of incidents
concerning a safe environment.
In review of areas where infants and children are inpatients, verify the security protections (such as alarms, arm
banding systems) in place. Determine how these protections are tested and where corrective/preventive action(s)
have been implemented.
Review and validate the system in place to protect patients from abuse, neglect and harassment of all forms,
whether from staff, other patients, visitors or other persons. Review and verify that the hospital has a written
procedure for investigating allegations of abuse and neglect including methods to protect patients from abuse,
Verify that the hospital has a process in place to notify appropriate agencies, including reporting requirements, as
applicable, regarding incidents involving abuse, neglect or harassment, in accordance with State and Federal Laws as
well as notification to any law enforcement or other agency (i.e. Child/Adult Protective Services)
In review of patient care areas, verify that medical records are not accessible to people not involved with the
patient’s care.
Verify that the hospital promotes and protects the patient’s right to access information contained in his/her clinical
records and provides these records to patients within a reasonable timeframe.
Patient visitation rights.
Review the hospital policies on visitation and validate that the policies delineate any reasonable clinical restrictions or
limitations, if needed.
Verify that the hospital has developed an active process for informing each patient (or representative, where
appropriate) of his or her visitation rights, including any clinical restriction or limitation on such rights.
Verify that all patients (or representative, where appropriate) are informed that they can receive the visitors whom
he or she designates, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic
partner), another family member, or a friend, and his or her right to withdraw or deny such consent at any time.
Verify that patients have been able to receive all of the visitors that were designated by the patient (or
representative, where appropriate) and that visitation privileges have been no more restrictive than those that
immediate family members would enjoy.
PR.3 ADVANCE DIRECTIVE
The organization must allow the patient to formulate advance directives and to have organization staff and
practitioners comply with the advance directives in accordance with Federal and State law, rules and regulations. The
organization must maintain written policies in accordance with 42 CFR Section 489.102 requirements for providers
and 42 CFR Section 489.104 regarding the effective dates for this requirement.
SR.1 The organization will provide written notice of its policies regarding the implementation of patients’
rights to make decisions concerning medical care, such as the right to formulate advance directives.
SR.1a The organization shall document in the patient’s medical record whether or not the patient
has executed an advance directive for all inpatients, emergency room patients, observation
status patients, and day surgery patients.
SR.2 The organization shall not condition the provision of care or otherwise discriminate based on the
execution of the advance directive.
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SR.3 The organization shall ensure compliance with State law regarding the provision of an advance
directive.
SR.4 The organization shall provide education for staff concerning its policies and procedures regarding
the advance directives.
SR.5 When an advance directive exists and is not in the patient’s medical record, a written policy for
follow-up and compliance shall exist.
Definitions:
An advance directive means a written instruction, such as a living will or durable power of attorney for health care,
recognized under State law (whether statutory or as recognized by the courts of the State), relating to the provision
of health care when the individual is incapacitated.
A psychiatric advance directive is akin to a traditional advance directive for health care. This type of advance
directive might be prepared by an individual who is concerned that at some time he or she may be subject to
involuntary psychiatric commitment or treatment. The psychiatric advance directive may cover a range of subjects,
and may name another person who is authorized to make decisions for the individual if he or she is determined to be
legally incompetent to make his/her own choices. State laws regarding the use of psychiatric advance directives
vary.
Interpretive Guidelines:
The patient (inpatient or outpatient) has the right to formulate advance directives and to have hospital staff
implement and comply with their advance directive in accordance with Federal and State law, rules and regulations.
Although both inpatients and outpatients have the same rights under 42 CR Section 482.13(a)(1), 42 CFR Section
489.102(b)(1) requires that notice of the hospital’s advance directive policy be provided at the time an individual is
admitted as an inpatient.
The hospital should also provide the advance directive notices to outpatients (or their representatives) that are in the
emergency department, who are in an observation status, or who are undergoing same-day surgery. The notice
should be presented at the time of registration. Notice is not required for other outpatients, given that they are
unlikely to become incapacitated.
42 CFR Section 489.102 also requires that the hospital provide community education regarding advance directives
and that the organization must document its efforts.
The hospital must communicate its policies regarding the implementation of advance directives, including a clear and
precise statement of limitation if the hospital cannot implement an advance directive on the basis of conscience. At
a minimum, a statement of limitation should:
•
Clarify any differences between institution-wide conscience objections and those that may be raised
by individual MD/DOs;
•
Identify the State legal authority permitting such an objection; and,
Describe the range of medical conditions or procedures affected by the conscience objection.
The hospital must document in a prominent part of the patient’s medical record whether or not the patient has
executed an advance directive.
The hospital must not condition the provision of care or otherwise discriminate against an individual on the basis of
whether or not the patient has executed an advance directive.
The hospital must ensure compliance with State law regarding the provision of an advance directive and inform
individuals that complaints that concern the advance directive requirements may be filed with the State survey
agency and this accreditation body.
When the advance directive exists, and is not in the patient’s medical record, a written policy must be in place to
address the follow-up and compliance. When necessary, the hospital will take the appropriate steps to secure a copy
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of the patient’s advance directives.
Surveyor Guidance:
In a sampling of patient records, review and verify that the hospital has complied with the patient’s advance
directive notice requirements.
Review and verify the hospital has a procedure in place to allow patients to formulate an advance directive or to
update their current advance directive.
Verify that the hospital educates its staff regarding advance directives, including psychiatric advance directives, as
indicated by hospital policy and state law.
Determine how the hospital advises inpatients, applicable outpatients, or their representatives, of the patient’s right
to formulate an advance directive and to have hospital staff comply with the advance directive in accordance with
State law.
PR.4 LANGUAGE AND COMMUNICATION
The organization shall inform the patient and/or legal representative of their rights in language or format that the
patient and/or legal representative understand.
SR.1 Organization policy and practice provides for competent individuals to interpret the patient’s
language for individuals who do not speak English or provide alternative communication aids for
those who are deaf, blind, or otherwise impaired.
Interpretive Guidelines:
The hospital will provide for interpretation for certain individuals who speak languages other than English, use
alternative communication techniques or aides for those who are deaf or blind, or take other steps as needed to
effectively communicate with the patient.
The hospital’s obligation to communicate with patients requires that the hospital present information in a manner
and form that can be understood (e.g., the use of large print materials, specialized programs to inform individuals
who are deaf or blind, use of interpreters, etc.).
Surveyor Guidance:
Verify that the hospital has alternative means, such as written materials, signs, or interpreters, to communicate
patients’ rights, when necessary.
Verify how the hospital meets the needs of these diverse patients.
PR.5 INFORMED CONSENT
The organization shall obtain an informed written consent from each patient or authorized representative for the
provision of medical and/or surgical care except in medical emergencies. The consent shall include an explanation of
risks, benefits, and alternatives for high-risk procedures, sedation, and participation in research projects, as defined
by the medical staff and State law.
Interpretive Guidelines:
All patients receiving either inpatient and outpatient care must complete an informed written consent form for all
procedures and treatments specified by the hospital’s medical staff, or State or Federal laws or regulations. In the
event of a medical emergency, the hospital is not required to obtain a written consent, but timely efforts should be
made to obtain an informed written consent from the patient’s authorized representative.
The procedures/treatments which will require the hospital to obtain patient written consent will at least include:
high-risk procedures (including blood transfusions); sedation; participation in research projects; and, filming or
videotaping.
Definition elements: Informed consent means the patient or patient representative is given (in a language or means
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of communication he/she understands) the information, explanations of risks, benefits and alternatives, needed in
order to consent to a procedure or treatment. Informed consent would include that the patient is informed as to
who will actually perform planned surgical interventions.
When practitioners other than the primary surgeon will perform important parts of the surgical procedures, even
when under the primary surgeon’s supervision, the patient must be informed of who these other practitioners are, as
well as, what important tasks each will carry out. We recognize that at the time of the surgery, unforeseen
circumstances may require changing which individual practitioners actually are involved in conducting the surgery.
A properly executed informed consent form contains at least the following:
•
Name of patient, and when appropriate, patient’s legal guardian;
•
Name of hospital;
•
Name of specific procedure(s) or medical treatment);
•
Name of the responsible practitioner who is performing the procedure(s) or administering the medical
treatment;
•
Signature of patient or legal representative;
•
Date and time consent form is signed by the patient or the patient’s legal representative;
•
Statement that procedure/treatment including the anticipated benefits, material risks, and alternative
therapies, was explained to the patient or the patient’s legal representative; (Material risks could
include risks with a high degree of likelihood but a low degree of severity, as well as those with a
very low degree of likelihood but high degree of severity. Hospitals are free to delegate to the
responsible practitioner, who uses the available clinical evidence as informed by the practitioner’s
professional judgment, the determination of which material risks, benefits and alternatives will be
discussed with the patient.)
•
Name of person who explained the procedure to the patient or guardian.
Situations where the patient consents to a procedure and information was withheld from the patient, where if the
patient had been informed of that information, the patient may not have consented to the procedure or made the
same decisions would not be considered informed consent.
Surveyor Guidance:
Verify that the medical staff has specified which procedures or treatments require a written informed consent. Verify
that medical records contain consent forms for all procedures or treatments as required by hospital policy.
In a sampling of patient records, review and validate that consent forms are properly executed and contain at least
the information identified above.
PR.6 GRIEVANCE PROCEDURE
The organization shall develop and implement a formal grievance procedure that provides for the following:
SR.1 A list of whom to contact;
SR.2 The governing body’s review and resolution of grievances or the written delegation of this function to
an appropriate person or committee;
SR.3 A referral process for quality of care issues to the Utilization Review, Quality Management or Peer
Review functions, as appropriate; and,
SR.4 Specification of reasonable timeframes for review and prompt response and resolution to patient
grievances.
SR.5 Grievance resolutions must be in writing and directed to the patient. The grievance resolution shall
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include the following:
SR.5a Organization contact person;
SR.5b Steps taken to investigate;
SR.5c Results of the grievance process; and,
SR.5d Date of completion.
Interpretive Guideline:
The hospital must develop and implement a formal grievance procedure to identify the process that will be followed
and the required correspondence, including grievance resolution, to be provided to the patient.
Definition elements: A “patient grievance” is a formal or informal written or verbal complaint that is made to the
hospital by a patient, or the patient’s representative, when a patient issue cannot be resolved promptly by staff
present. If a complaint cannot be resolved promptly by staff present or is referred to a complaint coordinator, patient
advocate, or hospital management, it is to be considered a grievance.
The patient should have reasonable expectations of care and services and the facility should address those
expectations in a timely, reasonable, and consistent manner. Regardless of the nature of the grievance, the hospital
should make sure that it is responding to the substance of each grievance while identifying, investigating, and
resolving any deeper, systemic problems indicated by the grievance. A written response is required for the initial
acknowledgement of the grievance (which may or may not include the resolution) within the timeframe of 7 to 10
days. If the grievance is not resolved, the investigation is not complete, or if the corrective action is still being
evaluated, the hospital’s response should address that the hospital is still working to resolve the complaint and
states that the hospital will follow-up with another written response within a specified timeframe (depending on what
actions the hospital may have to take). Not all grievances must be in writing if the hospital is addressing a relatively
minor request from a patient and that it can be immediately resolved. When appropriate, the grievance resolution
will include:
•
Identification of the organization’s contact person;
•
Steps taken to investigate;
•
Results of the grievance process; and,
•
Date of completion.
The hospital must inform the patient and/or the patient’s legal guardian/representative of the internal grievance
process, including whom to contact to file a grievance (complaint). As part of its notification of patient rights, the
hospital must inform the patient that he/she may submit a grievance with the State agency (the State agency that
has licensure survey responsibility for the hospital) directly, regardless of whether he/she has first used the
hospital’s grievance process. The hospital must provide the patient or the patient’s representative a phone number
and address for submitting a grievance with the State agency.
The hospital is required to have procedures for referring Medicare beneficiary concerns to the assigned Quality
Improvement Organization (QIO) at the beneficiary's request if they have a complaint regarding quality of care,
disagree with a coverage decision, or they wish to appeal premature discharge; additionally, hospitals must inform
all beneficiaries of this right.
Surveyor Guidance:
Review and verify the hospital’s policies and procedures to assure that its grievance process encourages all
personnel to alert appropriate staff concerning any patient grievance and that the hospital’s governing body has
approved the grievance process.
Verify that the hospital’s process assure that grievances involving situations or practices that place the patient in
immediate danger, are resolved in a timely manner.
Verify that information is provided to patients to explain the hospital’s grievance procedures. Verify that time frames
are established to review and respond to patient grievances.
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Verify that the hospital provides written notices (responses) to patients as required.
Review the time frames established to review and respond to patient grievances and that these are being met.
Verify that these time frames are clearly explained in the information provided to the patient and explains the
hospital’s grievance process.
PR.7 RESTRAINT OR SECLUSION
All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the
right to be free from restraint or seclusion, of any form, that is not medically necessary, or that is imposed by staff
as a means of coercion, discipline, convenience, or retaliation. Each patient should be treated with respect and
dignity.
SR.1 The patient has the right to be free from restraints of any form that are not medically necessary or
are used as a means of coercion, discipline, convenience, or retaliation by staff.
SR.1a A restraint is any manual method, physical or mechanical device, material, or equipment
that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or
head freely; or a drug or medication when it is used as a restriction to manage the patient’s
behavior or restrict the patient’s freedom of movement and is not a standard treatment or
dosage for the patient’s condition.
A restraint does not include devices, such as orthopedically prescribed devices, surgical
dressings or bandages, protective helmets, or other methods that involve the physical
holding of a patient for the purpose of conducting routine physical examinations or tests, or
to protect the patient from falling out of bed, or to permit the patient to participate in
activities without the risk of physical harm (this does not include a physical escort).
SR.1b A restraint includes a drug or medication used as a restriction to manage the patient’s
behavior or restrict the patient’s freedom of movement and is not a standard treatment or
dosage for the patient’s condition.
SR.1c Seclusion is the involuntary confinement of a patient alone in a room or area from which the
patient is physically prevented from leaving. A situation where a patient is restricted to a
room or area alone and staff are physically intervening to prevent the patient from leaving
the room or area is also considered seclusion.
Seclusion may only be used for the management of violent or self- destructive behavior
that jeopardizes the immediate physical safety of the patient, a staff member, or others.
Interpretive Guidelines:
An object may be a restraint by functional definition. Anything that prevents the patient access to his or her body,
moving their arms, legs, or ambulating in a normal manner I s a restraint.
A device is considered a restraint if it is applied to someone who is physically able to get up and they are prevented
from doing so. Under this definition, many commonly used hospital devices and practices could meet the definition of
a restraint, including:
•
Tucking a patient’s sheets in so tightly that he or she cannot move; or
•
Wrist holders, highly padded mitts or other types of devices would be considered a restraint. Using a
side rail to prevent a patient from voluntarily getting out of bed.
•
A restraint such as a soft wrist restraint, an arm restraint, wrapping or bundling, or some similar type
of intervention to prevent an infant or toddler from removing invasive lines or reopening a surgical
site, meets the definition of physical restraint and the requirements apply.
•
Placing hand mitts on infants would not be considered restraint but pinning or otherwise attaching
those same mitts to bedding would meet the definition of physical restraint and the requirements
would apply.
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•
Devices that serve multiple purposes such as Geri chair or side rails, when they have the effect of
restricting a patient’s movement and cannot be easily removed by the patient, constitute a restraint.
•
Physical holding of a patient for the purpose of conducting routine physical examination or tests is
permitted. However, patients do have the right to refuse treatment. This includes the right to refuse
physical examinations or tests. Holding a patient in a manner that restricts the patient’s movement
against his or her will would be considered a restraint. This includes therapeutic holds.
Siderails
It is standard practice to raise the side rails when a patient is on a stretcher, recovering from anesthesia, sedated,
experiencing involuntary movement, or on certain types of therapeutic beds to prevent the patient from falling out of
the bed.
Devices that protect the patient from falling out of bed are not restraints. However, raising all four side rails in order
to restrain a patient, (as this may immobilize or reduce the ability of a patient to move his or her arms, legs, body,
or head freely) to ensure the immediate physical safety of the patient then the rule applies. A patient’s history of
falls without current evidence of falling is not a reason to use restraints.
A disoriented patient may see the side rail as a barrier to be climbed over or may attempt to wriggle through split
rails or to the end of the bed to exit the bed. As a result, this patient may have an increased risk for a fall or other
injury by attempting to exit the bed with the side rails raised. The risk presented by side rail use should be weighed
against the risk presented by the patient’s behavior as ascertained through individualized assessment.
Raising fewer than four side rails when the bed has more than two side rails, would not necessarily immobilize or
reduce the ability of a patient to move
A functional definition does not name each device and situation that can be used to inhibit an individual’s movement,
and promotes looking at situations on a case-by-case basis. Therefore, if the effect of using an object fits the
definition of restraint for that patient at that time, then for that patient at that time, the device is a restraint.
Regardless of whether a restraint is voluntarily or involuntarily, this standard applies. A request from a patient or
family member for the application of a restraint which they would consider to be beneficial is not a sufficient basis for
the use of a restraint intervention.
Exemptions from requirements of the restraint or seclusion standards include:
•
The use of handcuffs or other restrictive devices applied by law enforcement officials who are not
employed by or contracted by the hospital when the use of such devices is for custody, detention,
and public safety reasons, and is not involved in the provision of health care. The application,
monitoring, and removal of forensic devices are the responsibility of the law enforcement officers.
The hospital and its staff are responsible for providing safe and appropriate care to the patient.
•
A voluntary mechanical support used to achieve proper body position, balance, or alignment so as to
allow greater freedom of mobility than would be possible without the use of such a mechanical
support. Some patients lack the ability to walk without the use of leg braces, to sit upright without
neck, head, or back braces.
•
A medically necessary and voluntary positioning or securing device used to maintain the position, limit
mobility, or temporarily immobilize during medical, dental, diagnostic, or surgical procedures is not
considered a restraint.
•
Physically holding a patient during a forced psychotropic medication procedure is considered physical
restraint and is not included in this exception.
•
Recovery from anesthesia that occurs when the patient is in the intensive care unit or recovery room
is considered part of the surgical procedure; therefore, medically necessary restraint use in this
setting would not need to meet the requirements of this standard. However, if the intervention is
maintained when the patient is transferred to another unit, or recovers from the effects of the
anesthesia (whichever occurs first), a restraint order would be necessary and the requirements of
the standard(s) must be followed.
•
Age or developmentally appropriate protective safety interventions (such as stroller safety belts,
swing safety belts, high chair lap belts, raised crib rails, and crib covers) that a safety-conscious
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child care provider outside a health care setting would utilize to protect an infant, toddler, or
preschool-aged child would not be considered restraint or seclusion for the purposes of this
standard The use of these safety interventions needs to be addressed in the hospital’s policies or
procedures.
Drugs Used as a Restraint
If the use of the medication for the patient meets the definition of a drug used as a restraint, the assessment,
monitoring and documentation requirements apply. The use of PRN orders is prohibited for drugs or medications that
are being used as restraints.
The standard is not intended to interfere with the clinical treatment of patients who need medication in appropriate
doses that are standard medical or psychiatric treatment for the patient’s condition. Medications such as the
following are not considered restraints when based on the assessed needs of the particular patient with careful
monitoring to minimize adverse effects:
•
Therapeutic doses of psychotropic medication for patients who are suffering from serious mental
illness to improve their level of functioning so that they can more actively participate in their
treatment.
•
Therapeutic doses of anti-anxiety medications to calm the patient who is anxious.
•
Appropriate doses of sleeping medication prescribed to treat insomnia.
•
Appropriate doses of analgesic medication ordered for pain management.
Therefore, a notation that certain medications are a standard treatment for a patient’s medical or psychiatric
conditions and are NOT subject to the requirements of the restraint standard is acceptable in the following
circumstances:
•
The medication is used within the pharmaceutical parameters approved by the Food and Drug
Administration (FDA) and the manufacturer for the indications it is manufactured and labeled to
address, including listed dosage parameters.
•
The use of the medication follows national practice standards established or recognized by the medical
community and/or professional medical association or organization.
•
The use of the medication to treat a specific patient’s clinical condition is based on that patient’s
symptoms, overall clinical situation, and on the physician’s or other LIP’s knowledge of that patients
expected and actual response to the medication.
An additional component of ‘‘standard treatment’’ for a medication is the expectation that the standard use of a
medication to treat the patient’s condition enables the patient to more effectively or appropriately function in the
world around them than would be possible without the use of the medication. If the overall effect of a medication is
to reduce the patient’s ability to effectively or appropriately interact with the world around the patient, then the
medication is not being used as a standard treatment for the patient’s condition.
Example: “A patient has Sundowner’s Syndrome, a syndrome in which a patient’s dementia becomes more apparent
at the end of the day than the beginning of the day. The patient may become agitated, angry, or anxious at
sundown. This may lead to wandering, pacing the floors, or other nervous behaviors. The unit’s staff find the
patient’s behavior bothersome, and ask the physician to order a high dose of a sedative to keep him in bed. The
patient has no medical symptoms or condition that indicates that he needs a sedative. In this case, for this patient,
the sedative is being used as a restraint for staff convenience. Such use is not permitted by the regulation. The
regulation does not allow a drug to be used to restrain the patient for staff convenience, to coerce or discipline the
patient, or as a method of retaliation.”
The standard supports existing State laws that provide more vigorous promotion of the patient’s choice and rights.
Therefore, when a State’s law prohibits the administration of drugs against the wishes of the patient without a court
order, the State law applies.
Seclusion
Seclusion can only be used in emergency situations if needed to ensure the immediate safety of the patient
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exhibiting violent or self-destructive behavior (and others) and less restrictive interventions have been determined to
be ineffective.
In a therapeutic time out, the staff and patient collaboratively determine when the patient has regained self-control
and is able to return to the treatment milieu. In seclusion, this judgment is made by the clinicians—that is, an
agitated patient may feel that he or she should be released, even though the patient’s behavior continues to be
violent or self-destructive.
A situation where a patient is restricted to a room or area alone and staff are physically intervening to prevent the
patient from leaving the room or area is also considered seclusion
SR.2 The hospital will keep the patient safe and protect their rights when restraints or seclusion are
applied.
SR.2a The hospital will have policies and procedures designed to protect patient rights and dignity
with regards to the use of restraint and seclusion, and ensure safety of the patient, staff
and others. These policies and procedures guide staff in the safe use of restraint or
seclusion, and incorporate all elements of the Federal and State regulations.
SR.2b Restraint or seclusion may only be imposed to ensure the immediate physical safety of the
patient, staff, or others and must be discontinued at the earliest possible time.
SR.2c Restraint or seclusion may only be used when less restrictive interventions have been
determined to be ineffective to protect the patient or others from harm.
SR.2d The type or technique of restraint or seclusion used must be the least restrictive
intervention that will be effective to protect the patient or others from harm.
SR.2e The use of restraint or seclusion must be in accordance with a written modification to the
patient’s plan of care, and implemented in accordance with safe and appropriate restraint
and seclusion techniques as determined by hospital policy in accordance with State law.
SR.2f Restraint and seclusion may not be used simultaneously, unless the patient is continually
monitored, face-to-face, by an assigned, trained staff member; or continually monitored by
trained staff using both video and audio equipment.
SR.2f(1) This monitoring must be in close proximity to the patient.
SR.2f(2) For the purposes of this provision, ‘‘continually’’ means ongoing without
interruption.
Interpretive Guidelines:
Restraint or seclusion must not be used unless it is to meet the patient’s individual clinical needs. The uses of
restraint or seclusion should be discontinued as soon as possible.
Restraint use associated with non-violent or non-self-destructive behavior may be indicated, but only when it directly
supports medical healing.
When a patient’s violent or self-destructive behavior presents an immediate and serious danger to the patient or
others, immediate action is needed. While staff should be mindful of using the least intrusive intervention, it is
critical that staff considers all interventions available to them and that the intervention selected be effective in
protecting the patient or others from harm.
A patient may experience a severe medication reaction that causes him or her to become violent or a patient may be
withdrawing from alcohol and having delirium tremors (DTs). The patient is agitated, combative, verbally abusive,
and attempting to hit staff. Regardless of facility type, such emergencies generally pose a significant risk for patients
and others. For the safety of the patient and others, the use of restraint or seclusion may be necessary to manage
the patient’s violent or self-destructive behavior that jeopardize the immediate physical safety of the patient, a staff
member, or others when less restrictive interventions have been determined to be ineffective to protect the patient,
staff, or others from harm. It is not targeted only at patients on psychiatric units or those with behavioral/mental
health care needs. The patient protections contained in this standard apply to all patients when the use of restraint
or seclusion becomes necessary.
The use of restraint or seclusion is a last resort when alternatives or less restrictive measures have been determined
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ineffective to protect the patient or others from harm, not a standard response to a behavior or patient need.
Further, the decision to use a restraint is implemented following a comprehensive individual assessment that
concludes that for this patient at this time, the use of less intrusive measures pose a greater risk than the risk of
using a restraint or seclusion.
The comprehensive assessment should include a physical assessment to identify medical problems that may be
causing behavior changes in the patient. For example, temperature elevations, hypoxia, hypoglycemia, electrolyte
imbalances, drug interactions, and drug side effects can cause confusion, agitation, and combative behaviors.
Addressing these medical issues can often eliminate or minimize the need for the use of restraints.
When assessing and planning the care for the patient, the hospital should consider whether he/she has a medical
condition or symptom that indicates a current need for a protective intervention to prevent the patient from walking
or getting out of bed. A restraint must not serve as a substitute for adequate staffing to monitor patients.
Comprehensive assessment of the patient and the environment, in conjunction with individualized patient care
planning, should be used to determine those interventions that will best ensure the patient’s safety and well-being
with the least risk.
The most appropriate intervention that will ensure the safety of the patient is to be selected following a
comprehensive assessment of the patient, the environment, and the patient’s individualized treatment plan.
Hospital policies should address the frequency of assessment and the assessment parameters (for example, vital
signs, circulation checks, hydration needs, elimination needs, level of distress and agitation, mental status, cognitive
functioning, skin integrity).
Hospital policies should guide staff in how to determine an appropriate interval for assessment and monitoring based
on the individual needs of the patient, the patient’s condition, and the type of restraint used. It may be that a
specific patient needs continual face-to-face monitoring; or that the patient’s safety, comfort, and well-being are
best assured by periodic checks.
The hospital is responsible for providing the level of monitoring and frequency of reassessment that will ensure the
patient’s safety.
The use of a restraint or seclusion intervention is documented in the patient’s plan of care or treatment plan based
on an assessment and evaluation of the patient.
The plan of care or treatment plan should be reviewed and updated in writing within a timeframe specified by
hospital policy. The plan should reflect an individualized approach that is in the best interest of the patient and
promotes the patient’s health, safety, dignity, self-respect, and self-worth.
The risks associated with any intervention must be considered within the context of an ongoing process of
assessment, intervention, evaluation, and re-evaluation.
The use of restraint or seclusion interventions must never act as a barrier to the provision of safe and appropriate
care, treatments, and other interventions to meet the needs of the patient.
Surveyor Guidance:
Review hospital policies relative to the use of restraint or seclusion to verify that they have been designed to protect
patient rights and all elements of Federal and State regulations are included:
•
These policies should conform to State law and indicate which QLPs are permitted to order restraints.
•
Verify that the hospital has defined who has the authority to discontinue restraints (based on State
law and hospital policies) and under what circumstances restraints are to be discontinued.
In a sampling of medical records of patients where restraint or seclusion has been applied, review and validate that
restraint or seclusion was appropriately used based upon the patient’s physical or mental condition before the
application of restraint or seclusion.
Verify that the rationale for restraint is described and the least restrictive technique was selected. Verify that staff
attempted other less restrictive measures before applying restraint or seclusion.
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Interview hospital staff to identify how they assess the patient and determine that the least restrictive interventions
would be ineffective to protect the patient, staff, and others from harm.
Review and validate if the hospital has applied the same type of restraint to other patients regardless of their
respective medical condition.
Verify that the plan of care is updated according to hospital policy and reflects continuous assessment, intervention,
evaluation, and reassessment as required.
SR.3 Order for Restraint or Seclusion:
SR.3a The use of restraint or seclusion must be in accordance with the order of a physician or
other QLP who is responsible for the care of the patient as specified under § 482.12(c) and
is authorized to order restraint or seclusion by hospital policy in accordance with State law.
SR.3b An order for restraint or seclusion must be obtained prior to the application of restraints,
except in emergency situations when the need for intervention may occur quickly;
SR.3c An order for restraint or seclusion is never to be written as a standing order or on an as
needed basis (PRN).
SR.3d The attending physician must be consulted as soon as possible if restraint or seclusion is
not ordered by the patient’s attending physician.
SR.3e Each order for restraint or seclusion used to manage violent or self-destructive behavior
that jeopardizes the immediate physical safety of the patient, a staff member, or others
based on the age of the patient.
SR.3e(1) Orders are limited to 4 hours for adults 18 years of age or older; 2 hours for
children and adolescents 9 to 17 years of age; and 1 hour for children under 9
years of age.
SR.3e(2) The restraint or seclusion order may only be renewed in accordance with these
limits for up to a total of 24 hours unless superseded by State law that is more
restrictive.
SR.3e(3) After 24 hours, and before writing a new order for the use of restraint or
seclusion for the management of violent or self-destructive behavior a physician
or other QLP (if allowed by State law) must see and assess the patient.
SR.3e(4) If the restraint or seclusion is discontinued prior to the expiration of the order, a
new order must be obtained prior to re-initiation of the restraint or seclusion.
SR.3f Each order for restraint used to ensure the physical safety of the non-violent or non-self-
destructive patient may be renewed, as authorized by hospital policy.
Interpretive Guidelines:
A QLP is any individual permitted by State law and hospital policy to order restraints and seclusion for patients
independently within the scope of the individual’s license and consistent with the individually granted clinical
privileges. This provision is not to be construed to limit the authority of a physician to delegate tasks to other
qualified healthcare personnel, that is, physician assistants and advanced practice nurses, to the extent recognized
under State law or a State’s regulatory mechanism, and hospital policy.
The standard requires that a physician or other QLP responsible for the care of the patient order restraint or
seclusion prior to the application of restraint or seclusion. In some situations, however, the need for a restraint or
seclusion intervention may occur so quickly that an order cannot be obtained prior to the application of restraint or
seclusion. In these emergency application situations, the order must be obtained either during the emergency
application of the restraint or seclusion, or immediately (within a few minutes) after the restraint or seclusion has
been applied. The failure to immediately obtain an order is viewed as the application of restraint or seclusion without
an order. The hospital should address this process in its restraint and seclusion policies and procedures. The policies
and procedures should specify who can initiate the emergency application of restraint or seclusion prior to obtaining
an order from a physician or other QLP.
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When the restraint or seclusion is not ordered by the patients attending physician, the order must be followed by
consultation with the patient’s treating physician as soon as possible.
Consultation ensures that the physician who has overall responsibility and authority for the management and care of
the patient is aware of and involved in the intervention. This also promotes continuity of care and elicits information
from the attending physician that might be relevant in choosing the most appropriate intervention for the patient.
Medical staff policies determine who is considered the treating (attending) physician. The intent of this standard is to
ensure that the physician who has overall responsibility and authority for the management and care of the patient is
aware of the patient’s condition and is aware of the restraint or seclusion intervention. It is important to consult with
the attending physician to promote continuity of care, to ensure patient safety, and to elicit information that might
be relevant in choosing the most appropriate intervention for the patient. The attending physician may have
information regarding the patient’s history that may have a significant impact on the selection of a restraint or
seclusion intervention or an alternative intervention, and the subsequent course of treatment. Therefore,
consultation should occur as soon as possible. Hospital policies and procedures should address the definition of ‘‘as
soon as possible’’ based on the needs of their particular patient population. However, any established time frames
must be consistent with “as soon as possible,” but ought not exceed 24 hours after restraint application, in the
absence of a shorter state timeframe requirement. A consultation that is not conducted prior to a renewal of the
order would not be consistent with the requirement, “as soon as possible.”
When the attending physician is unavailable, responsibility for the patient must be delegated to another physician,
who would then be considered the attending physician.
The attending practitioner must be able to conduct both a physical and psychological assessment of the patient in
accordance with State law, their scope of practice, and hospital policy
When implementing a protocol that includes the use of an intervention that meets the definition of a restraint, a
separate order must be obtained for the restraint.
The patient’s medical record must include documentation of an individualized patient assessment indicating that the
patient’s symptoms and diagnosis meet the-triggering criteria identified in the protocol. Restraint or seclusion use is
an exception, not a routine response to a certain condition or behavior.
Hospitals that utilize protocols would be expected to provide evidence that there has been medical staff involvement
in the development, review, and quality monitoring of their use.
A registered nurse can initiate restraint in an emergency situation:
•
In emergency situations, an order must be obtained either during the emergency application of the
restraint or seclusion, or immediately after the restraint has been applied. The hospital should
address this process in its restraint policies and procedures.
•
Hospital procedures shall specify who can initiate the use of restraint or seclusion in an emergency
prior to obtaining an order from a physician or other QLP.
Time limits on the length of each order only apply when restraint or seclusion are used to manage violent or self-
destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others.
•
The length-of-order requirement identifies critical points at which there is mandatory contact with a
physician or QLP responsible for the care of the patient.
•
A trained RN can reassess the patient when the original order is about to expire, and then contact the
physician or other QLP to obtain direction as to whether to renew the order (for up to 4 hours, 2
hours, or 1 hour, as permitted by the regulation) and whether other steps are to be taken.
•
If a patient remains in restraint or seclusion for the management of violent or self-destructive
behavior 24-hours after the original order,, a face-to-face assessment by a physician or other
QLP must occur before a new order for the continued use of restraint or seclusion is written.
The regulation does not require the ordering QLP to be physically present to re-evaluate the need for continuing
restraint for non-violent and non-self-destructive behaviors. Hospitals have the flexibility to determine time frames
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for the restraint of the non-violent, non-self-destructive patient. These time frames should be addressed in policies
and procedures. However, the requirement that restraint use be ended at the earliest possible time applies to all
uses of restraint. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient,
staff, or others and must be discontinued at the earliest possible time (see PR.7, SR.2b).
Surveyor Guidance:
Review the medical records of patients that required restraint or seclusion to verify that:
• The attending physician was consulted of the need for restraint or seclusion, as soon as possible,
according to hospital policy
• The attending physician was contacted prior to the expiration of orders for restraint or seclusion
SR.4 One Hour Face-to-Face Evaluation.
The condition of the patient must be continuously assessed, monitored, and reevaluated.
SR.4a When restraint or seclusion is used to manage violent or self-destructive behavior that
jeopardizes the immediate physical safety of the patient, a staff member, or others, a
physician or other QLP, or a RN or PA trained in accordance with the requirements specified
under PR.7 must see the patient face-to-face within 1- hour after the initiation of the
intervention to evaluate:
SR.4a(1) The patient’s immediate situation;
SR.4a(2) The patient’s reaction to the intervention;
SR.4a(3) The patient’s medical and behavioral condition; and,
SR.4a(4) The need to continue or terminate the restraint or seclusion.
SR.4b If the 1-hour face-to-face evaluation is conducted by a trained RN or PA, the attending
physician or other QLP responsible for the care of the patient must be consulted as soon as
possible after completion of the evaluation.
Interpretive Guidelines:
The 1-hour face-to- face evaluation includes both a physical and behavioral assessment of the patient. Therefore,
the practitioner who conducts this evaluation must be able to complete both a physical and behavioral assessment of
the patient in accordance with State law, his or her scope of practice, and hospital policy. An evaluation of the
patient’s medical condition would include a complete review of systems assessment, behavioral assessment, as well
as review and assessment of the patient’s history, drugs and medications, most recent lab results, etc. The purpose
is to complete a comprehensive review of the patient’s condition to determine if other factors, such as drug or
medication interactions, electrolyte imbalances, hypoxia, sepsis, etc., are contributing to the patient’s violent or self-
destructive behavior.
When a trained RN or PA conducts the 1-hour evaluation, the physician is consulted, but is not required to come to
the hospital to see and evaluate the patient 1-hour after the initiation of the restraint or seclusion.
The physician can determine the need for immediate or further onsite evaluation based upon the patient’s
symptoms, condition, and history.
Telephone consultation may be acceptable for this consultation.
The 1-hour face-to-face evaluation only applies when restraints, use of a medication as a restraint, or seclusion are
used to manage violent or self-destructive behavior.
If a patients’ violent or self-destructive behavior is resolved and the restraint or seclusion is discontinued before the
practitioner arrives to perform the one hour face to face evaluation, a practitioner is still required to see the patient
face to face within one hour after the initiation of the intervention. Ending the intervention prior to the 1-hour point
does not mean that the mandated assessment and consultation are no longer necessary. The patient’s behavior
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warranted the use of a restraint or seclusion which indicates a serious change in a patient’s condition and must be
assessed.
State law (by statute or regulation) regarding the 1-hour face-to-face evaluation should be followed if more
restrictive than these requirements.
Surveyor Guidance:
Validate the competency of personnel conducting the 1-hour face-to-face evaluation. The 1-hour face-to- face
evaluation includes both a physical and behavioral assessment of the patient. Therefore, the practitioner who
conducts this evaluation must be able to complete both a physical and behavioral assessment of the patient in
accordance with State law, his or her scope of practice, and hospital policy
Generally, practitioners such as social workers, psychologists and other mental health workers are not qualified to
conduct a physical assessment, nor is it in their scope of practice.
Review a sampling of medical record for patients where restraint or seclusion was applied and review documentation
to confirm that:
• The patient received a face-to-face medical and behavioral evaluation within 1 hour of the intervention
by an appropriate person identified in hospital policy
• Consultation with the attending physician has taken place as soon as possible following the 1-hour
face-to-face evaluation
• The patient’s condition and reaction to the intervention was documented.
SR.5 Assessment, Monitoring, and Evaluation of the Restrained or Secluded Patient
SR.5a The condition of patients in restraint or seclusion is monitored and assessed by a physician,
other licensed independent practitioner or trained staff at an interval determined by hospital
policy, at least every 24 hours.
SR.5a(1) Hospital policies address the frequency of assessment and the assessment
parameters (for example, vital signs, circulation checks, hydration needs,
elimination needs, level of distress and agitation, mental status, cognitive
functioning, skin integrity).
SR.5a(2)
Hospital policies guide staff in how to determine an appropriate interval for
assessment and monitoring based on the individual needs of the patient, the
patient’s condition, and the type of restraint used (for example, every 15 minutes).
SR.5b Restraint or seclusion must be discontinued at the earliest possible time, regardless of the
length of time identified in the order.
SR.5c If restraint and seclusion are used simultaneously, the patient must be continually
monitored, faceto- face, by an assigned, trained staff member; or continually monitored by
trained staff using both video and audio equipment.
SR.5c(1)
This monitoring must be in close proximity to the patient.
SR.5c(2) For the purposes of this provision, ‘‘continually’’ means ongoing without interruption
Interpretive Guidelines:
All restraint interventions must be based on the individual clinical needs of a particular patient at a particular time as
demonstrated by documented ongoing assessments of that patient.
Ongoing assessment and monitoring of the patient’s condition are crucial for prevention of patient injury The
selection of an intervention and determination of the necessary frequency and level of assessment and monitoring
should be individualized, taking into consideration variables such as the patient’s condition, cognitive status, risks
associated with the use of the chosen intervention, and other relevant factors.
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Staff determines the appropriate level of monitoring and frequency of assessment based on hospital policy, an
individualized patient assessment, and type of intervention used.
The attending physician should be kept informed about the patient’s status.
After 24 hours, a face-to-face assessment by a physician or other QLP must occur before a new order is written for
restraints or seclusion for the violent or self-destructive patient
Restraint or seclusion must be ended at the earliest possible time, regardless of the length of time identified in the
order.
Restraint or seclusion may only be employed while the unsafe situation continues. Once the unsafe situation ends,
the use of restraint or seclusion should be discontinued.
If restraint or seclusion is discontinued prior to the expiration of the original order, a new order must be obtained
prior to reinitiating the use of restraint or seclusion:
•
Staff cannot discontinue an order and then restart it because that would constitute a PRN order.
•
A temporary release that occurs for the purpose of caring for a patient’s needs, for example, toileting,
feeding, and range of motion, is not considered a discontinuation of the intervention.
•
Example: When a trial period of observation out of restraints is initiated and the patient again exhibits
the symptoms that prompted the prior use of restraints, and the patient is placed in restraint
again, a new order would be required. This episode cannot be considered as part of the original
episode/order as it would be considered a PRN order which is not permitted.
•
Example: A patient is released from restraint or seclusion. If this patient later exhibits violent or self-
destructive behavior that jeopardizes the immediate physical safety of the patient, a staff
member, or others that can only be handled through the use of restraint or seclusion, a new
order would be required.
•
Example: When patient’s behavior responds to the intervention in 20 minutes, the restraint or
seclusion should be discontinued, even if the order was given for up to 4 hours.
All requirements specified under this standard apply in the simultaneous use of restraint and seclusion:
•
Continual face-to-face monitoring (that is, moment to moment) is only required when restraint and
seclusion are used simultaneously to address violent or self-destructive behavior that
jeopardizes the immediate physical safety of the patient, a staff member, or others.
•
Monitoring in ‘‘close proximity’’ to the patient is intended to ensure that staff is immediately available
to intervene and render appropriate interventions to meet the patient’s needs.
The use of PRN orders for drugs or medications is only prohibited when a drug or medication is being used as a
restraint.
EXCEPTIONS
Geri chair. If a patient requires the use of a Geri chair with the tray locked in place in order for the patient to safely
be out of bed, a standing or PRN order is permitted. Given that a patient may be out of bed in a Geri chair several
times a day, it is not necessary to obtain a new order each time.
Raised side rails. If a patient's status requires that all bedrails be raised (restraint) while the patient is in bed, a
standing or PRN order is permitted. It is not necessary to obtain a new order each time the patient is returned to bed
after being out of bed.
Repetitive self-mutilating behavior. If a patient is diagnosed with a chronic medical or psychiatric condition,
such as Lesch-Nyham Syndrome, and the patient engages in repetitive self-mutilating behavior, a standing or PRN
order for restraint to be applied in accordance with specific parameters established in the treatment plan would be
permitted. Since the use of restraints to prevent self-injury is needed for these types of rare, severe, medical and
psychiatric conditions, the specific requirements (1-hour face-to-face evaluation, time-limited orders, and evaluation
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every 24 hours before renewal of the order) for the management of violent or self- destructive behavior do not
apply.
Surveyor Guidance:
In a sampling of medical records of patients where restraint or seclusion has been applied review and validate that:
The patient was monitored and reassessed according to timeframes defined by hospital policy
The patient was reassessed according to criteria established by hospital policy
SR.6. Documentation in the Medical Record
SR.6a When restraint or seclusion is used, there must be documentation in the patient’s medical
record of the following:
SR.6a(1) A description of the patient’s behavior and the intervention used;
SR.6a(2) Alternatives or other less restrictive interventions attempted (as applicable);
SR.6a(3) The patient’s condition or symptom(s) that warranted the use of the restraint or
seclusion; and,
SR.6a(4) The patient’s response to the intervention(s) used, including the rationale for
continued use of the intervention
SR.6a(5) The 1-hour face- to-face medical and behavioral evaluation and assessment findings
if restraint or seclusion is used to manage violent or self- destructive behavior that
jeopardizes the immediate physical safety of the patient, a staff member, or others;
SR.6a(6) Monitoring and assessment activities
SR.6a(7) Written modification to the patient’s plan of care or treatment plan based on an
assessment and evaluation of the patient.
SR.6a(8) The plan of care or treatment plan should be reviewed and updated in writing within
a timeframe specified by hospital policy.
SR.6a(9) Additional elements of documentation, such as name, title, and credentials of staff
members involved in the procedure, should be specified in hospital policy.
SR.6b In addition, staff must document in the patient’s medical record the date and time any
death associated with restraint or seclusion use was reported to CMS. (see section on
Report of Death)
Interpretive Guidelines:
Patient care staff must be able to demonstrate that the restraint or seclusion intervention is the least restrictive
intervention that protects the patient’s safety. Patient care staff must demonstrate through their documentation that
the use of restraint or seclusion is based on individual assessment of the patient the assessments and
documentation of these assessments must be ongoing in order to demonstrate a continued need for restraint or
seclusion.
Surveyor Guidance:
Verify and validate that there is documentation of ongoing patient assessment (e.g. skin integrity, circulation,
respiration, intake, and output, weight, hygiene, injury).
In a sampling of patient records, where restraint or seclusion was applied during their hospital stay, review and
validate that the record contains:
•
A description of the patient’s behavior and the intervention used. Alternative/less restrictive
interventions attempted, as applicable
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•
The patient’s response to interventions used, including rationale for continued use
•
The one-hour face-to-face medical and behavioral evaluation when restraint or seclusion is used to
manage violent or self-destructive behavior
•
Monitoring and assessment activities
SR.7 Quality Monitoring
SR.7a The use of restraint and seclusion is to be monitored and evaluated on a continual basis as
part of the organization’s QMS (See also QM.7.SR.6).
SR.7b Evidence of prolonged restraint, as defined by the organization, and, if possible, actions
taken to reduce or eliminate the use of restraints must be analyzed by the treatment team,
SR.7c Aggregate data regarding the use of restraint must be collected and analyzed for the
identification of patterns and trends. Intensive analysis must be implemented in the event a
patient is injured through the use of restraint or a staff member is injured through the
application of a restraint.
Interpretive Guidelines:
The data collected will be aggregated and analyzed to ensure that only clinically necessary restraints are used with a
focus on patient safety.
Actions are to be implemented to ensure that standards for restraint or seclusion are applied appropriately as they
relate to the patient with non-violent/ non-self-destructive behavior and the patient with violent/self-destructive
behavior.
As a means of documenting this assessment and monitoring, the use of restraints must be recorded within a log or
other data collection mechanism for monitoring. The documentation must include identification of:
•
Shift;
•
Date, time of order;
•
Staff who initiated the process;
•
The length of each episode;
•
Date and time each episode was initiated;
•
Day of the week each episode was initiated;
•
Type of restraint or seclusion used (including physical restraint or drug used as restraint);
•
Compliance with requirements defined in the standards;
•
Whether injuries were sustained by the individual or staff;
•
Age of individual; and,
•
Gender of individual.
Data must be analyzed for the identification of patterns and trends including:
•
Patterns of excessive use
•
Use of physical restraint or drugs used as restraint to substitute for adequate staffing, monitoring,
assessment, or investigation of the reasons behind patient behavior such as wandering or getting
up in the night, which may be indicative of unmet patient care needs
•
Opportunities for improving compliance with the requirements of the standards
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Twenty-four hours of restraint or seclusion for the management of violent or self-destructive behavior that
jeopardizes the immediate physical safety of the patient, a staff member, or others is an extreme measure which
could potentially seriously harm the patient. When there is evidence of prolonged restraint, as defined by the
organization, and, if possible, actions taken to reduce or eliminate the use of restraints must be analyzed and
presented for management review.
Intensive analysis must be implemented in the event a patient is injured through the use of restraint or a staff
member is injured through the application of a restraint.
Surveyor Guidance:
Review the aggregate data regarding the use of restraints and seclusion to see if the hospital has identified patterns
and trends.
Confirm that the organization can demonstrate implementation of corrective or preventive action where analysis of
data reflects variation.
Verify the hospital had conducted an intensive analysis in the event a patient is injured through the use of restraint
or a staff member is injured through the application of a restraint.
PR.8 RESTRAINT OR SECLUSION: STAFF TRAINING REQUIREMENTS
The patient has the right to safe implementation of restraint or seclusion by trained staff.
SR.1 Staff must be trained and able to demonstrate competency in the application of restraints,
implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or
seclusion
SR.1a Training must occur before performing any of these actions, as part of orientation, and
subsequently on a periodic basis consistent with hospital policy.
SR.2 The hospital must require appropriate staff to have education, training, and demonstrated knowledge
based on the specific needs of the patient population in at least the following:
SR.2a Techniques to identify staff and patient behaviors, events, and environmental factors that
may trigger circumstances that require restraint or seclusion;
SR.2b The use of non-physical intervention skills, including de-escalation and dealing with
aggressive behavior;
SR.2c Choosing the least restrictive intervention based on an individualized assessment of the
patient’s medical or behavioral status or condition;
SR.2d The safe application and use of all types of restraint or seclusion used in the hospital,
including training in how to recognize and respond to signs of physical and psychological
distress (for example, positional asphyxia);
SR.2e Clinical identification of specific behavioral changes that indicate that restraint or seclusion
is no longer necessary;
SR.2f Monitoring the physical and psychological well-being of the patient who is restrained or
secluded, including but not limited to, respiratory and circulatory status, skin integrity, vital
signs, and any special requirements specified by hospital policy associated with the 1-hour
face-to-face evaluation; and;
SR.2g The use of first aid techniques and certification in the use of cardiopulmonary resuscitation,
including recertification requirements.
SR.3 At a minimum, physicians, and other QLP’s authorized to order restraint or seclusion by hospital
policy in accordance with State law must have a working knowledge of the hospital policy regarding
the use of restraint or seclusion.
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SR.3a Physician and other QLP training requirements must be specified in hospital policy
SR.4 Individuals providing staff training must be qualified as evidenced by education, training, and
experience in techniques used to address patients’ behaviors.
SR.5 The hospital must document in the staff personnel records that the training and demonstration of
competency were successfully completed.
SR.6 Registered Nurses and Physician Assistants that are selected to perform face-to-face evaluations of
patients that exhibit violent or self-destructive behaviors are identified and trained in the
expectations of this role, specifically how to evaluate and document the:
SR.6a Patient’s immediate situation;
SR.6b Patient’s reaction to intervention
SR.6c Patients medical and behavioral condition including a review of systems, patient history,
medications, and lab results; and
SR.6d Need to continue or terminate the restraint or seclusion.
Interpretive Guidelines
Staff who have direct contact with patients must be trained and able to demonstrate competency before applying
restraints, implementing seclusion, providing care for a patient in restraint or seclusion, or with assessing and
monitoring the condition of the restrained or secluded patient:
•
The facility identifies the appropriate clinical staff that must be trained in the application, monitoring,
patient care, and discontinuation of restraint or seclusion.
•
Non-nursing staff must be included to the extent that they are involved with restraint use.
•
Application of restraint or seclusion by an untrained staff member, including contract staff, would
constitute a violation of this requirement.
Hospitals are required to provide a safe environment for the patients in their care. When restraint or seclusion
techniques are used, patients are placed at a higher risk for injuries or even death. Hospitals must require
appropriate staff (all staff who apply restraint or seclusion, monitor, access or provide care for a patient in restraint
or seclusion) to receive education and training in the use of first aid techniques as well as training and certification in
the use of cardiopulmonary resuscitation.
Training must be comprehensive and must involve demonstration and return demonstration
The written training curriculum reflects the defined competency skill sets defined for each level of clinical personnel:
•
The hospital is expected to provide education and training at the appropriate level to the appropriate
staff based upon the specific needs of the patient population being served.
•
Hospital policies and emergency procedures for managing violent or self-destructive behaviors in
included in the training curriculum.
•
It is appropriate to have different levels of training for different individuals depending upon their
involvement with restraints.
The training curriculum is reviewed annually and revised as indicated, incorporating relevant findings from QA/PI
activities.
Accurate recordkeeping of training sessions, including titles of the employees who attend must be stored onsite
where the actual documents will be easily accessible for review. In order to ensure that the employee training is
complete, all the required components of the program must be covered.
Surveyor Guidance:
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Review hospital policy and training records to verify:
•
Competency skill sets for clinical staff are identified.
•
Training content and frequency are identified to meet the standard.
•
Trainers are qualified as evidenced by education, training, and experience.
•
All staff that applies or monitors restraint or seclusion, including Physical Therapy, Radiology, and
Respiratory Care staff receive training and have demonstrated competency related to use of
restraint and seclusion.
•
Policy describes training requirements for physicians and licensed independent practitioners.
•
Training has been provided for the medical staff, QLP’s and hospital staff as defined.
Review and validate that the hospital has documented instructional training for the use of all restraint techniques
used and the alternatives to the use of restraint and seclusion.
Review selected personnel files to verify that clinical staff have demonstrated appropriate competency.
PR.9 RESTRAINT OR SECLUSION: REPORT OF DEATH
SR.1 Hospitals must report deaths associated with the use of restraint or seclusion directly to CMS in
accordance with 42 CFR Section 482.13(g), the Conditions of Participation, and the State Operations
Manual.
SR.2 Staff must document in the patient’s medical record the date and time the death was reported to
CMS.
Interpretive Guidelines:
The CMS regional office must be informed by telephone, facsimile or electronically, as determined by CMS, no later
than the close of business on the next business day following knowledge of the patient's death of each reportable
death. Form CMS-10455 (
http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS10455.pdf) is used
to report deaths associated with the use of restraint or seclusion.
The CMS regional office will determine if an investigation is warranted.
The following information should be available when notifying the CMS regional office:
1.
Provider information
a.
Hospital name, address, and NPI provider number
2.
Patient information
a.
Patient name, date of birth
b.
Admitting diagnosis
c.
Date of admission
d.
Date and time of death
e.
Cause of death
f.
Circumstances surrounding the death
3.
Associated restraint reporting criteria
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a.
Death occurred while the patient was in restraint or in seclusion
b.
Death occurred within 24 hours after restraint or seclusion was removed
c.
Death occurred within one (1) week after restraint or seclusion where it is reasonable to assume
that use of restraint or placement in seclusion contributed directly or indirectly to a patient's
death, regardless of the type(s) of restraint used on the patient during this time.
“Reasonable to assume” in this context includes, but is not limited to, deaths related to
restrictions of movement for prolonged periods of time, or death related to chest
compression, restriction of breathing, or asphyxiation.
d.
When no seclusion has been used and when the only restraints used on the patient are those
applied exclusively to the patient's wrist(s), and which are composed solely of soft, non-
rigid, cloth-like materials, the hospital staff must record in an internal log or other system,
the following information:
i.
Any death that occurs while a patient is in such restraints.
ii.
Any death that occurs within 24 hours after a patient has been removed from such
restraints.
e.
The staff must document in the patient's medical record the date and time the death was:
i.
Reported to CMS for deaths or
ii.
Recorded in the internal log or other system for deaths described in paragraph 3(d).
f.
For deaths described in paragraph 3(d), entries into the internal log or other system must be
documented as follows:
i.
Each entry must be made not later than seven days after the date of death of the
patient.
ii.
Each entry must document the patient's name, date of birth, date of death, name of
attending physician or other licensed independent practitioner who is responsible for
the care of the patient as specified under Sec. 482.12(c), medical record number,
and primary diagnosis(es).
iii.
The information must be made available in either written or electronic form to CMS
immediately upon request.
4.
Hospital care information
a.
Reason for use of restraint or seclusion and alternatives attempted
b.
Type: physical restraint, seclusion, or drug used as restraint
c.
Restraint type details
d.
For drugs used as restraint; drug name, dosage, number of doses given
e.
Total length of time in restraint or seclusion
f.
Date and time originally ordered and applied
g.
Most recent order date and time
h.
Monitoring methods including: face to face evaluation, date and time of last face-to-face
evaluation, documented frequency of monitoring, date and time last monitored
5.
Results of any facility investigation
Surveyor Guidance:
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Review the hospital policy on reporting deaths that occur while a patient is restrained or in seclusion, within 24 hours
of removal, or where it is reasonable to assume that a restraint or seclusion contributed to a patient’s death.
Confirm that deaths associated with use of restraint or seclusion were reported in compliance with CMS Conditions of
Participation and the State Operations Manual.
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INFECTION PREVENTION AND CONTROL (IC)
IC.1 INFECTION PREVENTION and CONTROL SYSTEM
SR.1 The organization shall have a process in place, as required and/or recommended by the Centers for
Disease Control (CDC) and related professional organizations, to maintain a sanitary environment for
organization patients, staff, and others,
SR.2 The organization shall have a documented process, policies and procedures to define how infections
and communicable diseases are prevented, controlled and investigated throughout the organization.
SR.3 The Infection Prevention and Control System shall be evaluated at least annually. This evaluation
shall be forwarded to Quality Management oversight group.
SR.4 The documented process shall define the following:
SR.4a A person or persons must be designated as infection control officer or officers to develop
and implement policies governing control of infections and communicable diseases. The
designated infection control officer or officers shall have the appropriate qualifications and
experience as defined by the organization and shall govern the policies for controlling
infections and communicable diseases.
SR.4b Any designated practitioner shall have completed a course in basic surveillance by a
recognized body or show evidence that they have supervision by a qualified infection control
practitioner. If in the role five years or longer there must be evidence of pertinent
continuing education related to infection control, minimally every two years;
SR.4c The infection control officer or officers must develop a system for identifying, reporting,
investigating, and controlling infections and communicable diseases of patients and
personnel and,
SR.4d The maintaining and control of records to account for incidents related to infections and
communicable diseases.
SR.5 Infections and communicable diseases shall be measured and analyzed to identify any patterns or
trends.
SR.6 The organization, through its chief executive officer, medical staff and nurse executive shall ensure
that the Infection Control System and associated activities adequately address issues identified
throughout the organization and there are prevention, correction, improvement and training
programs to address these issues and provide adequate resources to accomplish the associated
activities of the infection control program.
SR.7 Significant infection control data/information shall be disseminated no less than quarterly to the
organization oversight group responsible for the infection control function.
SR.8 Surveillance methodology shall be appropriate for the population(s) served and approved no less
than annually by the Infection Control oversight. The inpatient and outpatient populations shall be
reported to this oversight group as an annual summary of reported illnesses.
Interpretive Guidelines:
The hospital must maintain an Infection Prevention and Control System for the prevention, control, and surveillance
of infections (which includes, but is not limited to healthcare associated infections) and communicable diseases of
patients and personnel (which includes, but is not limited to patient care staff).
Definitions:
Infectious disease – a change from a state of health to a state in which part or all of a host’s body cannot function
normally because of the presence of an infectious agent or its product.
Infectious agent – a living or quasi-living organism or particle that causes an infectious disease, and includes
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bacteria, viruses, fungi, protozoa, helminthes, and prions.
Communicable disease – a disease associated with an agent that can be transmitted from one host to another.
Infection control professional – a person whose primary training is in either nursing, medical technology,
microbiology, or epidemiology and who has acquired specialized training in infection control.
Healthcare-associated infection - one that develops in a patient who is cared for in any setting where healthcare is
delivered (e.g., acute care hospital, chronic care facility, ambulatory clinic, dialysis center, surgical center, home)
and is related to receiving health care (e.g., was not incubating or present at the time healthcare was provided).
The Infection Prevention and Control System surveillance program will include specific measures for prevention,
detection, control, intervention, education, collection of data and investigation of infections and communicable
diseases in the hospital that covers patients and hospital staff. The Infection Prevention and Control System program
must be continually evaluated for effectiveness and when necessary, corrective and/or preventive action must be
taken to reduce risks of infections. The Infection Prevention and Control System should be conducted in accordance
with nationally recognized infection control practices or guidelines, as well as applicable regulations of other federal
or state agencies. Examples of organizations that promulgate nationally recognized infection and communicable
disease control guidelines, and/or recommendations include: the CDC (including ACIP and HICPAC), APIC, SHEA,
SGNA, and AORN. OSHA also issues federal regulations applicable to infection control practice.
The hospital must provide for and maintain a sanitary environment to avoid the sources and transmission of
infections and communicable diseases. All areas of the hospital must be regularly cleaned and sanitary including all
hospital units, campuses and off-site locations (as applicable). The Infection Prevention and Control surveillance
program will include monitoring of housekeeping and maintenance (including when applicable areas of the hospital
are under repair, renovation, or construction) as well as any other activities to ensure the hospital maintains a
sanitary environment.
The hospital must provide adequate resources to accomplish the activities of the Infection Prevention and Control
System when assessing the need for resources; the organization should consider the patient population and
complexity of services provided as a part of the process for evaluation and provision of resources.
The organization shall have a documented process, policies and procedures to define how infections and
communicable diseases are prevented, controlled and investigated throughout the organization. These policies and
procedures will include:
•
Maintenance of a sanitary physical environment, including;
•
Ventilation and water quality control issues
•
Safe air handling systems in areas of special ventilation, such as operating rooms, intensive care
units, and isolation rooms
•
Food sanitation, storage and handling
•
Cleaning and disinfecting surfaces, carpeting, and furniture
•
Textiles reprocessing, storage and distribution
•
Disposal of regulated and non-regulated waste
•
Pest control
No items shall be stored under any sink in a Healthcare Facility except where the organization has developed a
written policy that specifically identifies the items that are permissible to be stored under sinks. Procedures to
identify and maintain areas under sinks used for storage must be part of the Infection Control Management Plan. No
patient care items are permitted to be stored under sinks in any policy.
Note: The accepted NIAHO
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definition of healthcare facilities:
NFPA 99: “buildings or portions of buildings in which medical, dental, psychiatric, nursing, obstetrical, or surgical
care are provided.”
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NFPA 70 and 70E adds more to this definition: “Health care facilities include, but are not limited to hospitals, nursing
homes, limited care facilities, clinics, medical and dental offices, and ambulatory care centers.”
NFPA 45 and 5000 include in addition: “whether permanent or movable”
•
Measures related to hospital staff
•
Evaluation of immunization status for designated infectious diseases
•
Circumstances when screens are to be conducted of staff for infections or other risks when
individuals may be exposed
•
When restrictions will be imposed on staff from providing direct patient care and/or required to
remain away from the healthcare facility entirely
•
Measures to evaluate staff and volunteers exposed to patients with infections and communicable
diseases
•
orientation and on-going training regarding the prevention and control of infections and
communicable diseases
•
Mitigation of risks associated with patient infections present upon admissions to include:
•
Early identification of patients who require isolation and techniques for precaution in accordance with
CDC guidelines
•
Appropriate use of personal protective equipment (i.e. gowns, masks, gloves, eye protection)
•
Mitigation of risks contributing to healthcare-acquired infections:
•
Surgery-related infection risk mitigation measures
•
Implementing appropriate prophylaxis to prevent surgical site infections such as a protocol to assure
that antibiotic prophylaxis is administered to prevent surgical site infections for appropriate
procedures and discontinued appropriately after surgery
•
Addressing aseptic technique practices used in surgery and invasive procedures outside the
operating room, including sterilization of instruments
•
Other hospital-acquired infection risk mitigation measures
•
Promotion of hand washing hygiene among all staff and employees, including use of alcohol-based
hand sanitizer
•
Measures specific to prevention of infections caused by Multi-Drug - resistant organisms (MDRO).
This applies to, but is not limited to, organisms such as methicillin-resistant staphylococcus aureus
(MRSA), clostridium difficile (C.dif), vancomycin-resistant enterococci (VRE), carbapenem-resistant
entobacteriaceae (CRE) and multidrug-resistant gram-negative bacteria.
•
Measures specific to prevention of central-line associated bloodstream infection (CLABSI), such as a
bundle or protocol for reducing infections of central venous catheters specifying aseptic precautions
for line insertions, care of inserted lines, and prompt removal when the line is no longer needed.
•
Measures specific to prevention of other device-associated infections such as those associated with
ventilators, tube feeding, urinary catheters, etc. (VAP, CAUTI)
•
Isolation procedures and requirements for immuno-suppressed patients
•
Safe Injection Practice Program
•
Care techniques for tracheostomy care, respiratory therapy, burns and other situations that reduce a
patient’s resistance to infection
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•
Use of disinfectants, antiseptics and germicides as instructed
•
Appropriate use of facility and medical equipment including negative and positive pressure room
equipment, portable air filtration equipment, enclosed beds, UV lights, and other equipment used to
control the spread of infectious agents
•
Adherence to CDC and other nationally recognized guidelines for infection prevention and control
precautions
•
Education of patients, visitors, caregivers, and staff about infections and communicable diseases and
methods to reduce transmission in the hospital and community
•
Active Surveillance methods for:
•
Obtaining and review data on infections and communicable diseases selected for monitoring
•
Monitoring and evaluating practices of asepsis
•
Authority and indications for obtaining microbiological cultures from patients and the environment,
as indicated
•
A designated Infection Control Officer and his or her scope of responsibilities;
•
Development and implementation of infection control measures
•
Mitigation of risks associated with patient infections and risks contributing to healthcare-acquired
infections
•
Program evaluation and revisions (as necessary)
•
Coordination as required by law with Federal, State, and local emergency preparedness and health
authorities to address communicable disease threats, bioterrorism, and outbreaks
•
Compliance with the requirements for reporting to local health authorities
•
Roles and responsibilities for infection control within the hospital and how various committees and
departments interface with the infection control program
•
The hospital leaders are responsible for implementing and ensuring corrective/preventive action(s)
are implemented and effective in addressing infection control issues.
•
A process for identifying, reporting, investigating preventing, controlling infections and
communicable diseases; to include both inpatient and outpatient populations as well as hospital
staff;
•
Records to be maintained and controlled to account for incidents related to infections and
communicable diseases;
•
Log of incidents related to infections and communicable diseases is maintained (safe and
secure from unauthorized access, up-to-date, and readily accessible and retrievable) and
documents infections and communicable diseases in patients and staff (patient care staff
and non-patient care staff, including employees, contract staff and volunteers).
•
To protect privacy, the hospital may use codes instead of names in the log with a separate reference
document to interpret codes to address these incidents
•
Although not required, the hospital is encouraged to categorize the types of incidents such as:
•
Healthcare-associated infection including surgical site infections following inpatient or outpatient
procedures
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•
Patients or staff identified by laboratory cultures as colonized or infected with multi drug resistant
organisms (MDROs), as defined by the hospital
•
Patients who meet CDC criteria for requiring isolation precautions during their hospitalization
•
Patients or staff who are known or suspected to be infected with epidemiologically-significant
pathogens that are identified by the hospital or local, State or Federal health agencies
•
How infections and communicable diseases are measured and analyzed to identify any patterns or
trends;
•
A process for adequately addressing issues identified throughout the organization and for the
prevention, correction, improvement and training programs to address these issues;
•
A means of reporting data/information at least quarterly to the organization oversight group
responsible for the infection control function (i.e. Infection Control Committee);
•
How education of patients, family members and caregivers about infections and communicable
diseases is conducted;
•
Orientation of all new hospital personnel, including contract staff, students and volunteers, to
infections, communicable diseases, and to the infection control program; and,
•
A procedure for meeting the reporting requirements of the local health authority as required.
Surveyor Guidance:
Interview the infection control officer to verify the scope and activities of the hospital’s infection control program and
hospital issues regarding infection control.
Review the personnel file of the infection control officer(s) to verify that he or she is qualified through education,
training, experience, and certification or licensure to oversee the infection control program.
Review and validate that appropriate policies and procedures have been developed and implemented to identify,
prevent, monitor, report, investigate and measure the control of infections and communicable diseases;
•
Mitigation of risks associated with patient infections present on admission
•
Mitigation of risks contributing to healthcare-associated infections
Determine whether the infection control program is hospital-wide and identifies all hospital locations and take these
various locations into account under the program and there is active surveillance in place.
Review how areas of the hospital are monitored to include: areas where food is stored, prepared and served,
refrigerators, ice machines, air handlers, autoclave rooms/areas, ventilation systems, inpatient rooms, patient care
areas, laboratory, surgical areas, supply storage and where equipment is stored and cleaned.
During the survey, all surveyors should observe the sanitary condition of the physical environment, cleanliness of
rooms, surfaces, patient equipment, air inlets, mechanical rooms, food service activities, treatment and procedure
areas, surgical areas, central supply and storage areas, etc.
Review the (Infection Control Committee) meeting minutes to evaluate compliance with requirements and follow-up
on corrective and preventive actions taken.
Review a sampling or records for incidents related to infections and communicable diseases, including those
identified through employee health services to ensure that corrective and/or preventative actions were taken to
minimize risks. Review compliance with reporting requirements to the local health authority.
Verify that a log is maintained of incidents related to infections and communicable diseases and is easily accessible
and retrievable by the infection control officer and other appropriate staff.
Verify that there is coordination with Federal, State and local emergency preparedness and health authorities as
required by law to address communicable disease threats, bioterrorism, and outbreaks.
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Verify that the infection control program is under the scope of the hospital QMS and that infection control issues are
reported to the Medical Staff, Leadership and Nursing to ensure that corrective and/or preventative action (s) are
implemented and effective.
Review the on-going evaluation of the infection control program and revisions made to the program based in part on
this evaluation.
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MEDICAL RECORDS SERVICE (MR)
MR.1 ORGANIZATION
SR.1 Administrative responsibility for medical records shall rest with the medical record service of the
organization.
SR.2 The organization shall provide these services in accordance with the scope and complexities of
services offered and allocate the appropriate resources to ensure efficient functioning.
Interpretive Guidelines:
The hospital must have administrative responsibility for all medical records- both inpatient and outpatient. The
medical record service shall reflect the scope and complexities of services offered.
Definition: “Medical records” refers to the written documents, computerized electronic information, radiology film and
scans, laboratory reports and pathology slides, videos, audio recordings, and other forms of information regarding
the condition of a patient.
Surveyor Guidance:
Verify that the medical records service is designed to meet the needs of the hospital and the patients with respect to
the scope and complexities of services.
MR.2 COMPLETE MEDICAL RECORD
SR.1 The organization shall maintain an accurately written, promptly completed medical record for each
inpatient and outpatient.
SR.2 The organization shall have a process for providing services for the completion, filing, and retrieval of
the medical record. The process for completion of the medical record must address timeframes.
SR.3 Authenticity and security of all record entries shall be safeguarded.
Interpretive Guidelines:
The hospital must maintain a medical record for each inpatient and outpatient evaluated or treated in any part or
location of the hospital.
The hospital must ensure that all medical records accurately and completely document all orders, test results,
evaluations, care plans, treatments, interventions, care provided and the patient’s response to those treatments,
interventions and care.
The hospital will define the process for providing medical record services to encompass the completion, filing and
retrieval of medical records. In the event records are stored outside of the medical records office or off-premises
through a contractual arrangement, the hospital must ensure there is a process in place to protect and retrieve these
records in a timely manner.
The record must be completed promptly after discharge in accordance with State law and hospital policy but no later
than 30 days following discharge.
Surveyor Guidance:
Review the area(s) where medical records are maintained by the hospital.
Verify that a medical record is maintained for each person treated or receiving care.
Verify that medical records are stored and maintained in area(s) that ensure the records are secure, protected from
damage by flood, fire, and other casualties, and access is limited to authorized staff.
Verify that the hospital has a process to ensure that records are accurate, completed promptly, easily retrieved and
readily accessible in all area(s) where medical records are maintained.
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MR.3 RETENTION
SR.1 Medical records (original or legally reproduced form) shall be retained for a period of at least five (5)
years, or more if required by state or local laws.
SR.2 The coding and indexing system shall be designed in such a way that allows for timely retrieval by
diagnosis and procedure, in order to support medical care evaluation studies.
Interpretive Guidelines:
Medical records shall be retained in their original or legally reproduced form and maintained for minimum five (5)
years, or more if required by state or local laws. These records may be in the form of a hard copy, microfilm,
computer memory, or other electronic storage media. The hospital must have a process to promptly retrieve the
complete medical record of every individual evaluated or treated in accordance with Federal and State law and
regulations. Certain medical records may have retention requirements that exceed five (5) years (e.g.: FDA, OSHA,
and EPA).
Surveyor Guidance:
Verify that the control of medical record is in place and these records are retained for at least 5 years, or more if
required by State or local laws.
Verify that the hospital uses a coding and indexing system that allows for timely retrieval of patient records by
diagnosis and procedures.
MR.4 CONFIDENTIALITY
SR.1 Confidentiality of patient records shall be assured.
SR.2 Individuals who are authorized by the patient to receive information from or copies of records shall
follow processes designed to protect improper or inadvertent release of private information to
unauthorized individuals.
SR.3 The organization shall also ensure that the medical record cannot be altered or accessed by
unauthorized individuals.
SR.4 Original medical records shall be released by the organization only in accordance with Federal or
State laws, court orders, or subpoenas.
Interpretive Guidelines:
The hospital must have a means of ensuring that access to all information regarding patient’s records is limited to
those individuals designated by law, regulation, and policy or duly authorized as having a need to know. The process
must be designed to protect improper or inadvertent release of private information to unauthorized individuals.
Patient information will include; patient paper records, video, audio, and/or computer stored information.
The hospital will maintain a compliance program as required under the Health Insurance Portability and
Accountability Act (HIPAA).
Surveyor Guidance:
Verify that the hospital has a means of ensuring that access to patients’ records is limited to those individuals
designated by law, regulation, and policy or duly authorized as having a need to know.
Validate the policy and procedure for release of patient information and verify that copies of medical records and
other confidential patient information are released outside the hospital only upon written authorization of the patient,
legal guardian, or person with an appropriate “power of attorney” to act on the patient’s behalf, or only if there is a
properly executed subpoena or court order, or as mandated by Federal and State law.
Verify the methods in place to prevent unauthorized persons from gaining physical access or electronic access to
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information in patient records.
Validate the hospital’s current practices in place for protecting and securing the confidentiality of patient records.
Verify the elements of the hospital’s compliance program as required under (HIPAA).
MR.5 RECORD CONTENT
SR.1 The medical record shall contain information to:
SR.1a Justify admission and continued hospitalization;
SR.1b Support the diagnosis; and,
SR.1c Describe the patient’s progress and response to medications and services.
SR.2 All entries shall be:
SR.2a Legible, complete, dated and timed; and,
SR.2b Authenticated by the person responsible for providing or evaluating the services provided
consistent with hospital policy.
SR.3 Authentication may include written signatures or initials. Electronic authentication is permissible.
SR.4 All orders, including verbal orders, must be dated, timed, and authenticated promptly by the
ordering practitioner or by another practitioner who is responsible for the care of the patient only if
such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital
policies, and medical staff bylaws, rules, and regulations.
SR.4a Practitioners must separately date and time his/her signature, authenticating an entry, even
though there may already be a date and time on the document, since the document may
not reflect when the entry was authenticated.
SR.4b If a preprinted order set is used, the ordering practitioner must date, time, and authenticate
the last page of the order set, with the last page also identifying the total number of pages
in the order set.
SR.4c Changes, such as additions, deletions, or strike-outs of components that do not apply, that
have been made in the body of the preprinted order set are initialed and all internal pages
have been signed or initialed by the ordering practitioner.
SR.5 Verbal orders must be in accordance with Federal and State law and authenticated as required by
State law.
SR.5a Telephone or verbal orders are to be used infrequently and when used must be accepted
only by personnel authorized by the medical staff and in accordance with Federal and State
law.
SR.5b Verbal orders must be authenticated in accordance with Federal and State law by the
ordering practitioner or a practitioner responsible for the care of the patient. If there is not
State law that designates a specific timeframe for the authentication of verbal orders, the
orders must be authenticated within timeframe in accordance with hospital policy.
SR.5c For the limited time period defined in 42 CFR §482.24(c)(1)(ii), all such orders may be
dated, timed and authenticated by another practitioner who is responsible for the patient’s
care as specified in 42 CFR §482.12(c) and who is authorized to write orders in accordance
with hospital policy and State law.
Interpretive Guidelines:
The medical record must contain information such as notes, documentation, records, reports, recordings, test
results, and assessments to:
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•
Justify admission and continued hospitalization;
•
Support the diagnosis; and,
•
Describe the patient’s progress and response to medications and services
All entries in the patient’s medical record (information/documentation regarding evaluations, interventions, care
provided, services, care plans, discharge plans, and the patient’s response to those activities, laboratory reports, test
results, consults, assessments, radiology reports, dictated notes, etc. must be promptly filed in the patient’s medical
record in order to be available to the physician and other care providers.
These entries must be legible, complete, dated, timed and authenticated by the person responsible for prescribing
the services or by another practitioner who is responsible for the patient’s care . This individual must be authorized
to write orders in accordance with hospital policy and State law.
Order Sets:
There is no standard definition of a “standing order” in the hospital community at large (77 FR 29055, May 16,
2012), but the terms “pre-printed standing orders,” “electronic standing orders,” “order sets,” and “protocols for
patient orders” are various ways in which the term “standing orders” has been applied.
For purposes of brevity, CMS guidance generally uses the term “standing order(s)” to refer interchangeably to pre-
printed and electronic standing orders, order sets, and protocols. However, CMS also notes that the lack of a
standard definition for these terms and their interchangeable and indistinct use by hospitals and health care
professionals may result in confusion regarding what is or is not subject to the requirements of 42 CFR Section
482.24(c)(3), particularly with respect to “order sets.”
Not all pre-printed and electronic order sets are considered a type of “standing order” covered by 42 CFR Section
482.24(c)(3). Where the order sets consist solely of menus of treatment or care options designed to
facilitate the creation of a patient-specific set of orders by a physician or other qualified practitioner
authorized to write orders, and none of the treatment choices and actions can be initiated by non-
practitioner clinical staff before the physician or other qualified practitioner actually creates the patient-
specific order(s), such menus would not be considered “standing orders” subject to the requirements of
42 CFR Section 482.24(c)(3). In such cases the menus provide a convenient and efficient method for the
physician/practitioner to create an order, but the availability of such menu options does not create an “order set”
that is a “standing order” subject to the requirements of 42 CFR Section 482.24(c)(3). The physician/practitioner
may, based on his/her professional judgment, choose to: use the available menu options to create an order; not use
the menu options and instead create an order from scratch; or modify the available menu options to create the
order. In each case the physician/practitioner exercises his privileges to prescribe specific diagnosis and/or treatment
activities that are to be implemented for a patient.
When a practitioner is using a preprinted order set, the ordering practitioner may be in compliance with the
requirement to date, time, and authenticate an order if the practitioner accomplishes the following:
• Last page: Sign, date, and time the last page of the orders, with the last page also identifying the
total number of pages in the order set.
• Pages with Internal Selections: Sign or initial any other (internal) pages of the order set where
selections or changes have been made.
• The practitioner should initial/sign the top or bottom of the pertinent page(s);and
• The practitioner should also initial each place in the preprinted order set where changes, such
as additions, deletions, or strike-outs of components that do not apply, have been made.
• It is not necessary to initial every preprinted box that is checked to indicate selection of an
order option, so long as there are no changes made to the option(s) selected.
In the case of a pre-established electronic order set, the same principles would apply. The practitioner would date,
time, and authenticate the final order that resulted from the electronic selection/annotation process, with the
exception that pages with internal changes would not need to be initialed or signed if they are part of an integrated
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single electronic document.
Although verbal and telephone orders should be minimized when possible, for such orders, these must be in
accordance with Federal and State law and authenticated as required by State law. Verify the process for
authentication of verbal orders to ensure these are within the timeframes as stated according to Federal or State
law. If there is not a State law in place, verify that these orders are authenticated per hospital policy.
The expectation is that hospital policies and procedures for verbal orders will include a read-back and verify process,
in addition to specifying a timeframe for authentication of the orders.
The requirements for dating and timing do not apply to orders or prescriptions that are generated outside of the
hospital until they are presented to the hospital at the time of service. Once the hospital begins processing such an
order or prescription, it is responsible for ensuring that the implementation of the order or prescription by the
hospital is promptly dated, and timed in the patient’s medical record.
Verify the process for handling of verbal orders and that there have been measures put in place to effectively reduce
these, when possible.
Surveyor Guidance:
Review a sample of medical records during the survey. Validate that that MR.5 is consistently applied throughout the
hospital.
Verify that the hospital has policies and procedures in place for addressing verbal orders including a process for
read-back and verification to ensure accuracy of such orders.
Interview staff and review examples of verbal orders to verify this process for authentication and the read-back and
verification process.
Verify that within each medical record reviewed, the appropriate information is stated, timed, dated and
authenticated by the appropriate individual(s) and supports the diagnosis, treatment and other services provided to
the patient.
Verify that the last page of the orders on standing order sets identifies the total number of pages in the order set
and that they are timed, dated and authenticated.
Verify that internal pages of an order set where selections or changes have been made, have been initialed or signed
by the practitioner (top or bottom) and initialed in each place in the preprinted order set where changes, such as
additions, deletions, or strike-outs of components that do not apply, have been made.
MR.6 IDENTIFICATION OF AUTHORS
SR.1 The organization shall have a system to identify the author of each entry into the medical record.
Interpretive Guidelines:
The organization shall have a system to identify the author of each entry in the medical record. Entries may be made
only by individuals as specified in hospital and medical staff policies.
If the hospital, through the approval of the medical staff and leadership allow rubber stamps, the individual whose
signature the stamp represents shall place in the administrative offices of the hospital a signed statement to the
effect that he/she is the only one who has the stamp and is the only individual allowed to use it. No other individual
can be authorized to use the stamp under any circumstance.
All entries in the medical record must be legible. Any entry in the medical record that is not legible can be misread or
misinterpreted and could lead to medical errors or other adverse patient events.
Surveyor Guidance:
Verify that the hospital has a means of identifying authors for each entry in the patient medical record. The
organization shall have a policy in place that states who is allowed to document in the medical record and the means
for identifying the author. Review a sampling of records to verify the consistency of this process.
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In the event that the medical staff and leadership allow stamps to be used, verify that the stamps have been
approved and are only used by the individual identified on the stamp.
In the sample of records, validate that all entries in the medical record are legible.
MR.7 REQUIRED DOCUMENTATION
All records must document the following, as appropriate:
SR.1 All medical records of inpatients and all outpatient medical records for patients having same day
surgery or a procedure requiring anesthesia must contain evidence of a physical examination,
including a health history, must be performed no more than thirty (30) days prior to admission or
registration or within twenty-four (24) hours after admission:
SR.1a The history and physical completed and documented no more than 30 days before
admission or registration or 24 hours after admission, but prior to surgery or procedure
requiring anesthesia services; must be placed in the patient’s medical record within 24
hours after admission or registration, but prior to any surgery or procedure requiring
anesthesia services.
SR.1b When the history and physical is completed within 30 days prior to admission or
registration, an updated medical record entry documenting an examination for any changes
in the patient’s condition must be completed and documented in the patient’s medical
record within 24 hours after admission or registration, and prior to any high-risk procedure,
surgery, procedures requiring anesthesia services, or other procedures requiring an H&P.
SR.2 Admitting diagnosis,
SR.3 Results of all consultative evaluations of the patient and appropriate finding by clinical and other staff
involved in the care of the patient,
SR.4 Documentation of complications, organization acquired infections, and unfavorable reactions to drugs
and anesthesia,
SR.5 Properly executed informed written consent forms for procedures and treatments specified by the
medical staff, or by Federal or State law if applicable, signed by the patient or his/her authorized
representative,
SR.6 All practitioners’ orders, nursing notes, reports of treatment, medication records, radiology, and
laboratory reports, and vital signs and other information necessary to monitor the patient’s
condition,
SR.7 Discharge summary with outcome of hospitalization, disposition of case, and provisions for follow up
care,
SR.8 Final diagnosis with completion of medical records within thirty, (30) days following discharge.
Interpretive Guidelines:
The medical record must contain an H&P for all inpatients and outpatient medical records for patients having same
day surgery or a procedure requiring anesthesia and/or as indicated. The H&P must be performed by an authorized
practitioner no more than 30 days prior to admission or within 24 hours after admission.
The H&P must be placed in the patient’s medical record within 24 hours after admission. In the event the H&P is
completed within 30 days prior to admission, the hospital must ensure that the H&P is updated to document any
changes in the patient’s condition.
The patient’s medical record must document the following:
• Admitting diagnosis;
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• Results of all consultative evaluations of the patient and appropriate finding by clinical and other staff
involved in the care of the patient,
• Documentation of complications, organization acquired infections, and unfavorable reactions to drugs
and anesthesia;
• Properly executed informed written consent forms for procedures and treatments specified by the
medical staff, or by Federal or State law if applicable, signed by the patient or his/her authorized
representative;
• A properly executed consent form should reflect the patient consent process. All inpatient and
outpatient medical records must contain a properly executed informed consent prior to conducting
any procedure or other type of treatment when informed consent is required. A properly executed
consent form must be consistent with hospital policy as well as applicable State and Federal law or
regulation and at a minimum contain the following elements:
•
• Hospital name where procedure or treatment is to take place
• Description of the procedure or treatment for which consent is being given
• Name of the responsible practitioner performing the procedure or administering treatment
• Statement that the procedure or treatment, including the benefits, risks, and alternative
therapies, was explained to the patient or the patient’s legal representative
• Signature of the patient or patient’s legal representative
• Date and time the informed consent is signed by the patient or patient’s legal representative
If there is applicable State law governing the content of the informed consent, then the hospital must comply with
those requirements.
Additional information may be considered to include as a part of the informed consent form:
• Name of the practitioner who conducted the consent.
• All practitioners’ orders, nursing notes, reports of treatment, medication records, radiology, and
laboratory reports, and vital signs and other information necessary to monitor the patient’s
condition;
• Discharge summary with outcome of hospitalization, disposition of case, and provisions for follow up
care; and, Final diagnosis with completion of medical records within thirty, (30) days following
discharge.
Surveyor Guidance:
Determine that medical records contain a physical examination and medical history completed for each patient by an
authorized practitioner.
In a sampling of patient medical records, verify that the completion of the H&P was within the specified time frame
and appropriate documentation noted.
Verify the content and completeness of the H&P per organization policy.
In some cases the organization may accept an H&P that has been completed in the practitioner’s office, when this is
allowed, verify the process for ensuring that the appropriate documentation is present and completed per the
requirements of the organization and the H&P was completed within the required timeframe.
Verify that the H&P was completed no more than 30 days before or 24 hours after admission or registration and in
all cases involving surgery or procedures requiring anesthesia services or moderate/conscious sedation prior to the
surgery or procedure.
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Verify this documentation of the H&P was placed in the medical record within 24 hours after admission or
registration, and in all cases involving surgery or procedures requiring anesthesia services or moderate/conscious
sedation prior to the surgery or procedure.
Where the H&P is completed within 30 days before admission or registration and in all cases involving surgery or
procedures requiring anesthesia services or moderate/conscious sedation, the hospital must ensure that this H&P is
updated to document any changes in the patient’s condition.
If there are no changes to the H&P as written, the physician can simply document an update note stating that the:
• H&P has been reviewed,
• Patient has been examined, and
• Physician concurs with the findings of the H&P completed on the specified date or that ‘‘no change’’
has occurred in the patient’s condition since the H&P was completed.
Review a sample of medical records (inpatient and outpatient) to verify conformance to the appropriate elements
specified in the Interpretive Guidelines for MR.7.
Verify that the medical staff has specified which procedures and treatments require informed consent.
Ascertain that the completed forms contain at least the information specified in the Interpretive Guidelines for MR.7.
Compare the hospital standard informed consent form to the hospital’s policy regarding informed consent to verify
that the form is consistent with the policy. If there is applicable State law, verify that the form is consistent with the
requirements of that law.
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DISCHARGE PLANNING (DC)
DC.1 WRITTEN POLICIES
SR.1 Written policies shall be in place to establish a system for discharge planning that applies to all
patients.
SR.2 At an early stage of hospitalization, all patients who would be at risk for adverse health
consequences or negative outcomes without benefit of appropriate discharge planning shall be
identified and a plan developed to map a course of treatment aimed at minimizing the likelihood of
having any patient re-hospitalized for reasons that could have been prevented.
SR.2a Patients at high-risk of requiring post-hospital services must be identified through a
screening process.
SR.3 A discharge planning evaluation is provided for or upon the request of:
SR.3a The patients identified in DC1, SR.2;
SR.3b Any patients upon their request;
SR.3c A person acting on the patient’s behalf; or,
SR.3d The patient’s physician.
Interpretive Guidelines:
The hospital must define the discharge planning process and communicate it to all appropriate areas of the hospital.
This process is imperative in the patient care delivery system to ensure that patients’ needs are being met. This
applies to all types of hospitals and requires all hospitals to conduct appropriate discharge planning activities for all
inpatients. It applies to patients who are admitted to the hospital as inpatients. This does not apply to patients who
appear in a hospital emergency department but are not admitted as hospital inpatients. The hospital must identify
all patients who are at risk for adverse health consequences or negative outcomes so that the discharge planning
process and an educational plan may be developed.
There is no set time frame for identification of patients requiring a discharge planning evaluation other than it must
be done as early as possible. The timing is left up to the hospital, its staff, and attending MD/DO.
The discharge planning process can be initiated at the request of the patient, an individual acting on the patient’s
behalf or the physician caring for the patient.
Surveyor Guidance:
Review hospital policies and procedures regarding the discharge planning process. These policies and procedures
should address:
• Scope of the discharge planning process.
• The hospital’s high-risk screening procedure.
• Initiation of the discharge planning process;
• Individual(s) who may initiate this process;
• When the process is initiated as a part of the plan of care;
• Reassessment of discharge plans; and,
• Preparations for post-hospital care and how patients or those responsible for the patient are kept
informed of the progress.
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Sample patient records to see that the patient care plan includes the discharge planning process and associated
interventions.
Interview hospital staff who are involved in direct patient care to verify that discharge planning is an inherent part of
patient care delivery process.
DC.2 DISCHARGE PLANNING EVALUATION
SR.1 A registered nurse, social worker, or other appropriately qualified personnel must develop, or
supervise the development of the evaluation.
SR.1a The responsible personnel should have experience in discharge planning, knowledge of
social and physical factors that affect functional status at discharge, and knowledge of
community resources to meet post-discharge clinical and social needs.
SR.2 The discharge planning evaluation shall include:
SR.2a An evaluation of the likelihood of a patient needing post-hospital services and of the
availability of the services; and,
SR.2b An evaluation of the likelihood of a patient’s capacity for self-care or of the possibility of the
patient being cared for in the environment from which he or she entered the organization.
SR.2c A means to inform the patient or the patient’s family of their freedom to choose among
participating Medicare providers of post-hospital care services, and must, when possible,
respect patient and family preferences when they are expressed.
SR.3 The discharge planning evaluation shall be completed on a timely basis so that appropriate
arrangements are made before discharge, and unnecessary delays in discharge are avoided.
SR.4 The discharge planning evaluation shall be a part of the patient’s medical record and be used when
forming the discharge plan with the patient or individual acting on his or her behalf.
SR.5 If the results of the discharge evaluation so indicate, or at the request of the patient’s physician, a
registered nurse, social worker, or other appropriately qualified personnel shall develop, or supervise
the development of, a discharge plan and associated educational materials.
SR.5a The results of the discharge planning evaluations must be discussed with the patient or
individual acting on their behalf.
Interpretive Guidelines:
The discharge planning process will identify the following factors when patients are leaving the hospital setting:
functional status, cognitive ability of the patient and family support.
The hospital should have a screening process in place to identify patients who are at risk of requiring post-hospital
service. The hospital needs to ensure the availability of services that the patient may need and determine the
patient’s ability for self-care or care to be provided by another party when necessary.
The discharge planning process will be initiated in a timely manner in order for arrangements to be made for the
patient prior to discharge.
The documentation associated with the discharge planning process will be included as a part of the patient’s medical
record as a means of coordinating communication with other providers involved in the patient’s care throughout the
hospital. The patient’s physician, a registered nurse, social worker, and/or other qualified staff member will be
responsible for the development of information and materials to implement the discharge plan for the patient.
Surveyor Guidance:
Verify that the discharge planning is effective and an inherent part of the patient care delivery system through the
following means:
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• Interview staff to determine how patients are identified and require discharge planning;
• Review the hospital’s policy and procedures to verify that at-risk patients are provided discharge
planning;
• Sample records to see when the discharge planning process is initiated, the roles of individuals
involved in the process, reassessments as needed and the implementation of the discharge plan.
DC.3 PLAN IMPLEMENTATION
SR.1 The initial implementation of the patient’s discharge plan shall be performed by the organization.
SR.2 Patients shall be transferred or referred with necessary medical information, to appropriate
facilities, agencies, or outpatient services, as needed.
SR.3 When the discharge planning evaluation determines a referral is medically appropriate, the
organization shall give the patient a list of Medicare-participating providers (home health agencies,
skilled nursing facilities and other providers as applicable) (this will include those qualified to
receive the patient from the patient’s managed care organization where applicable) that are
available and serve the geographical area where the patient resides. The organization shall
document in the medical record that the patient (or authorized representative) received a copy of
the list and was advised of his/her freedom of choice.
Note: Home Health Agencies must request to be listed by the hospital as available.
SR.3a The organization must respect the choice of the patient or authorized representative except
in unusual circumstances. The organization may not lead, direct, specify, or otherwise limit
the selection of qualified Medicare-participating providers.
SR.3b The organization must identify in writing any Medicare-participating providers to which the
patient is referred in which the organization has a disclosable financial interest and any
Medicare-participating providers that has a disclosable financial interest in the organization.
Disclosable financial interests are defined by 42 CFR Section 420, Subpart C.
SR.4 When the organization must transfer or refer patients, the necessary medical information and other
supporting documentation must be provided to appropriate facilities, agencies or outpatient services
as needed, for follow-up or ancillary care.
Interpretive Guidelines:
The hospital must initiate the implementation of the discharge plan for the patient. When patients are transferred or
referred to another provider, the necessary medical information must be communicated to these providers as
needed. This includes arranging for necessary post-hospital services and care, and educating
patient/family/caregivers/community providers about post-hospital care plans.
The hospital must ensure that patients receive proper post-hospital care within the abilities of a hospital’s authority
under State law. The patient has the right to refuse discharge-planning services, but the hospital may still make
these services available to the patient. If a patient does exercise his or her right to refuse discharge planning,
written documentation of the refusal should be completed.
The hospital will maintain a list of Medicare-participating home health agencies (HHA) or skilled nursing facilities
(SNF) (including those qualified to receive the patient from the patient’s managed care organization where
applicable) that are available and serve the geographical area).
This list will be provided to patients when the discharge planning evaluation has determined that a referral is
medically appropriate for the patient. The patient has the freedom of choice for the providers on the list and the
hospital can take no part in leading, directing, or otherwise limit the selection of a qualified HHA or SNF.
If the hospital has a financial interest in any HHA or SNF or vice versa to which the patient is referred, it is the
responsibility of the hospital identify and define such financial interest in writing.
Surveyor Guidance:
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Sample patient records to verify that there objective evidence regarding the implementation of the discharge plan,
including communication of information to the patient (when possible) and the next provider.
Interview staff that are responsible for the patient’s care to determine the discharge planning process and how it has
been implemented. The following may be asked of the staff regarding this process:
• How are the patient’s rights, confidentiality, refusal, and preference considered?
• Is there documentation that care instructions have been communicated to the post hospital care
setting where the patient is being referred?
• Is there documentation that the HHA/SNF list is being provided to patients?
DC.4 EVALUATION
SR.1 The discharge plan shall be periodically reevaluated on an on-going basis to provide for changes in
the patient’s condition or circumstances. The reassessment must include a review of the discharge
plans to ensure that they are responsive to discharge needs.
SR.2 As needed, the patient and family members or interested persons shall be counseled to prepare
them for post-hospital care.
Interpretive Guidelines:
The purpose of a discharge planning evaluation is to determine continuing care needs after the patient leaves the
hospital setting. The hospital will determine the frequency and scope of the evaluation. Ideally, discharge planning
will be an interdisciplinary process, involving disciplines with specific expertise, as dictated by the needs of the
patient. It is important that this address the changes in the patient condition and other circumstances of the patient.
The hospital must have a mechanism in place for ongoing reassessment of its discharge planning process. The
hospital should assure the following factors in the reassessment process:
• Effectiveness of criteria to identify patients needing discharge plans;
• The quality and timeliness for discharge planning evaluations and discharge plans;
• The hospital discharge personnel to maintain complete and accurate information to advise patients
and their representatives of appropriate options; and
• The hospital has a coordinated discharge planning process that integrates discharge planning with
other functional departments, including the quality management and utilization review activities of
the institution and involves various disciplines.
Surveyor Guidance:
Sample patient records and other appropriate documentation to verify that the hospital is reevaluating the needs of
the patients on an ongoing basis, and prior to discharge, as they may need to change the discharge plan based on
the individual’s status. The discharge plan evaluation can be in the clinical notes if there is no separate form.
The surveyor may interview patients and their family members who are expecting discharge with approval from the
hospital. Feedback from this interview should address:
• If the hospital staff assisted in planning for post-hospital care;
• Involvement of the patient and family to assess their preparation(s) for discharge
• How ready do they feel they are prepared for discharge,
• How the patient/family was counseled by the staff regarding post-hospital care.
• Were they given the pamphlet, “Important Message from Medicare?”
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• Were they aware that they could request assistance with discharge planning?
Verify that the hospital includes the discharge planning process within the QMS and this process is effective.
Discuss with staff the extent and frequency the discharge planning process is reassessed and how this process is
evaluated for effectiveness.
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UTILIZATION REVIEW (UR)
UR.1 DOCUMENTED PLAN
The organization shall maintain a documented utilization review plan that provides for review of organizational and
medical staff services to patients, particularly those patients entitled to benefits under both Medicare and Medicaid.
The plan shall include:
SR.1 Responsibilities and authority for those involved in utilization review activities in a Utilization Review
(UR) Committee. A UR committee consisting of two or more practitioners must carry out the UR
function. At least two of the members of the committee must be doctors of medicine or osteopathy.
The other members may be any of the other types of practitioners as defined in MS.15 (SR.1)
SR.1a A staff committee of the institution; or
SR.1b A group outside the institution established by the local medical society and some or all of
the hospitals in the locality; or,
SR.1c Established in a manner approved by CMS.
SR.1d If, because of the small size of the institution, it is impracticable to have a properly
functioning staff committee, the UR committee must be established as such that;
SR.1d(1) The committee or group’s reviews may not be conducted by any individual who;
SR.1d(1)(a) Has a direct financial interest (for example, an ownership interest) in the
hospital; or
SR.1d(1)(b) Was professionally involved in the care of the patient whose case is being
reviewed.
SR.2 Requirement for all review findings in the aggregate to be reported to Quality Management
Oversight.
SR.3 Provision for avoidance of conflict by prohibiting any individual with any financial or professional
involvement in the case from participating in the review. This shall be strictly enforced.
SR.4 Review of:
SR.4a Medical necessity of admissions and extended stays;
SR.4b Appropriateness of setting; and,
SR.4c Medical necessity of professional services.
Interpretive Guidelines:
The hospital UR plan should include a delineation of the responsibilities and authority for those involved in the
performance of UR activities, define the requirement for all review findings to be reported to the Quality
Management Oversight body, and ensure that there is no conflict of interest (financial or otherwise) by those
individuals participating in the review.
Surveyor Guidance:
Verify that the hospital has a utilization review plan for those services furnished by the hospital and its medical staff
to patients, particularly those patients entitled to benefits under both Medicare and Medicaid.
Sample records and reports, and supporting documentation that UR activities are being performed as described in
the hospital UR plan.
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Verify the composition of the UR committee.
Review for any conflicts of interest or hospital ownership and that individuals, when applicable, in these
circumstances to ensure that these individuals are not included as a part of the Utilization Review process, as
appropriate.
Interview the chairperson of the UR Committee and/or other representative members of the committee to validate
their role in carrying out the UR plan.
• This may also include a review of the minutes of the UR committee to verify: members in attendance;
dates and times of the meetings; documentation of extended stay reviews with approval or
disapproval noted in a status report of any actions taken.
Note: Do not apply these UR requirements if any of the following situations apply:
• A Quality Improvement Organization (QIO) has assumed binding review for the hospital;
• The State has entered into a contract with a QIO that is deemed under 42 CFR §431.630, or
• CMS has determined that the UR procedures established by the State under Medicaid are superior to
these requirements and has required hospitals in that State to meet them. In these cases, the State
requirements are applied to both Medicare and the Medicaid patients. The State requirements will
then be used for survey in those States.
UR.2 SAMPLING
The review may be done before, at or after admission and may be conducted by sampling. The review shall include
medical necessity for the following:
SR.1 Admissions;
SR.2 Length of stay; and,
SR.3 Professional services furnished, including medications.
Surveyor Guidance:
Review the UR plan and other supporting documentation to determine that the medical necessity for patients is
reviewed with respect to admission, length of the stay, and professional services (including medications).
Note: This requirement does not apply to PPS-excluded hospitals or units.
UR.3 MEDICAL NECESSITY DETERMINATION
SR.1 The committee must review professional services, to determine medical necessity and to promote
the most efficient use of available health facilities and services.
SR.2 The determination that an admission or continued stay is not medically necessary may be made by
two members of the Quality Management Oversight group after the practitioner(s) caring for the
patient has (have) been notified and given an opportunity to present his/her views.
SR.2a Practitioner(s), the organization and the patient must receive written notification of a
decision that admission or continued stay is determined to be not medically necessary.
SR.2b The notification must be given no later than two (2) days after such decision is made.
Interpretive Guidelines:
The UR committee (or subgroup of the Quality Management Oversight Group) must include a physician and at least
two members of the Quality Management Oversight group. Cases that are determined to have not met medical
necessity will be reviewed. If the committee or subgroup agrees after reviewing the case where admissions, or
extended stay is not medically necessary or appropriate, the attending physician is notified and allowed an
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opportunity to present his or her views and any additional information relating to the patient’s needs for admissions
or extended stay.
The attending physician and the patient must receive notification within two days of the decision where the
admission or continued stay has been determined to be not medically necessary. If the attending physician does not
respond or does not contest the findings of the committee or subgroup or those of the physician who performed the
initial review, then the findings are deemed to be final.
In the event that the attending physician contests the committee or subgroup findings, or if he or she presents
additional information relating to the patient’s need for extended stay, at least one additional physician member of
the committee must review the case. If the two physician members determine that the patient’s stay is not medically
necessary or appropriate after considering all the evidence, their determination is deemed to be final.
A written notification of this decision must be sent to the attending physician and patient and the chief executive
officer within two days after such final decision.
Under no circumstance may a non-physician make a final determination that a patient’s stay is not medically
necessary or appropriate.
If, after a case that has been reviewed by the committee or subgroup thereof, the physician reviewer has
determined that an admission or extended stay is justified, the attending physician shall be so notified and an
appropriate date for subsequent extended stay review will be selected and noted on the patient’s record.
Surveyor Guidance:
Sample case reviews of where decisions involving admissions or extended stay that were deemed to be not medically
necessary and verify the decision-making and notification process to all respective parties as indicated in the
interpretive guidelines.
Definition: “Professional” services include the aspects of care rendered by laboratory personnel, physical therapists,
nurses, and others, as well as services provided by MD/DOs.
UR.4 EXTENDED STAY REVIEW
The utilization review plan must include a process to periodically review all patients who receive services during a
continuous period of extended duration.
SR.1 For organizations paid under the prospective payment system, all patients whose length of stay is
considered an outlier must be reviewed.
SR.2 All reviews must be conducted no later than seven (7) days after the day required in the utilization
review plan.
Interpretive Guidelines:
In accordance with 42 CFR Sections 482.30 (e)(1)(i) and e(1)(ii) - The scheduling of the periodic reviews may:
(i)
Be the same for all cases; or
(ii)
Differ for different classes of cases.
Surveyor Guidance:
Review the facility’s definition of stay of extended duration in the UR plan.
Verify that the hospital’s UR plan requires a periodic review of each current inpatient receiving hospital services of
extended duration and that the review is carried out as specified in the hospital’s UR plan.
Review minutes of the UR committee to determine that the periodic reviews of extended stay are carried out no later
than seven days after the day required in the hospital’s UR plan.
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PHYSICAL ENVIRONMENT (PE)
PE.1 FACILITY
The facility shall be constructed, arranged, and maintained to ensure patient safety, and to provide areas for
diagnosis and treatment and for special organization services appropriate to the needs of the community.
Note:
The standards incorporated by reference in this section are approved for incorporation by reference by the Director
of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may inspect a copy
at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and
Records Administration (NARA). For information on the availability of this material at NARA, call202-741-6030, or go
to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
If any changes in this edition of the Code are incorporated by reference, CMS will publish a document in the
FEDERAL REGISTER to announce the changes.
(1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169, www.nfpa.org,
1.617.770.3000.
(i) NFPA 99, Health Care Facilities Code, 2012 edition, issued August 11, 2011.
(ii) Technical interim amendment (TIA) 12-2 to NFPA 99, issued August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011.
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(xii) NFPA 110, Standard for Emergency and Standby Power Systems, 2010 edition, including TIAs
to chapter 7, issued August 6, 2009.
(2) [Reserved]
SR.1 The condition of the physical plant and the overall hospital environment must be developed and
maintained in such a manner that the safety and well-being of patients, visitors, and staff are
assured.
SR.2 The hospital must maintain adequate facilities for its services.
SR.2a Diagnostic and therapeutic facilities must be located for the safety of patients.
SR.2b Facilities, supplies, and equipment must be maintained to ensure an acceptable level of
safety and quality.
SR.2c The extent and complexity of facilities must be determined by the services offered.
SR.3 Except as otherwise provided in this section, the hospital must meet the applicable provisions and
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must proceed in accordance with the 2012 Health Care Facilities Code (NFPA 99 and Tentative
Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and TIA 12-6), Life Safety Code (NFPA
101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4), and NFPA
110, when a new structure is built or when an existing structure or building is renovated.
SR.3a Chapters 7 and 8 of the adopted Health Care Facilities Code do not apply to a hospital.
SR.3b If application of the Health Care Facilities Code required under paragraph (c) of this section
would result in unreasonable hardship for the hospital, CMS may waive specific provisions of
the Health Care Facilities Code, but only if the waiver does not adversely affect the health
and safety of patients.
SR.4 The organization shall have policies, procedures and processes in place to manage staff activities, as
required and/or recommended by local, State, and national authorities or related professional
organizations, to maintain a safe environment for the organization’s patients, staff, and others.
SR.5 The organization shall have a documented process, policies and procedures to define how
unfavorable occurrences, incidents, or impairments in the facility’s infrastructure, Life Safety, Safety,
Security, Hazardous Material/Waste, Emergency, Medical Equipment, and Utilities Management
Systems are prevented, controlled investigated, and reported throughout the organization.
SR.6 The organization shall evaluate the facility’s physical environment management systems at least
annually. This evaluation shall be forwarded to QMS oversight.
SR.7 Occurrences, incidents, or impairments shall be measured and analyzed to identify any patterns or
trends.
SR.8 The organization, through its senior leadership shall ensure that the physical environment and
associated management systems adequately address issues identified throughout the organization
and there are prevention, correction, improvement and training programs to address these issues.
SR.9 Significant physical environment data/information shall be disseminated regularly to Quality
Management oversight.
SR.10 The organization, through its senior leadership shall ensure that a tobacco-free policy be developed
and enforced campus-wide. Substantial progress toward complete conformity shall be demonstrated
over time. DNV GL- Healthcare will permit temporary tobacco use in the areas of the hospital where
patient visits may be abbreviated, in behavioral health units and other areas near the main campus
that are not under hospital control. In order for this to be permissible the hospital must obtain from
the local and/or state fire prevention agencies (Authority Having Jurisdiction or AHJ) written
documentation stating that these areas can be used for smoking while the hospital continues to
demonstrate progression toward a tobacco-free campus over time. (See the PE.1 Interpretive
Guidelines for specific direction on this procedure).
Interpretive Guidelines:
Interpretive Guidelines PE.1, SR.10:
To apply for areas in which smoking is acceptable,
1.
The documented AHJ permission must list:
a.
Which specific patient populations are permitted to participate in smoking
b.
What specific areas will be included in the policy
c.
Any specific applicable controls (e.g. smokers could be under physician’s orders and/or
accompanied by a security guard in specific approved areas)
d.
All arrangements/precautions/restrictions that pertain to this special permission
2.
The hospital must also perform a documented risk assessment of the area in which tobacco use is
proposed including:
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a.
The specific areas where smoking will be allowed
b.
The smoking areas are designed and built to resist fire, including but not limited to the
landscaping in the immediate area
c.
The smoking areas are located adequately from windows, air intakes and entrances to the
facility
d.
The hospital areas are compliant with NFPA 101, 2012 Chapter 18/19:18.7.4* or 19.7.4*
Once it is established that the arrangements described in the inquiry are endorsed/permitted by the local/state fire
prevention agency or AHJ documentation, then the hospital can continue demonstrate progression towards a
tobacco-free campus while using the AHJ-approved specific areas for smoking described in the hospital tobacco-free
policy and the AHJ documentation. The hospital policy must also include plans and/or processes that will be
developed and maintained to demonstrate continual progress in achieving a tobacco-free campus.
Facilities
The hospital must ensure that the condition of the physical plant and overall hospital environment is developed and
maintained in a manner that provides an acceptable level of safety and well-being of patients, staff and visitors.
Supplies
The hospital must ensure that supplies are maintained to provide an acceptable level of safety and quality for
patients. Among other things, this means that the hospital identifies the supplies required to meet its patients’ needs
for both day-to-day operations as well as those supplies that are likely to be needed in likely emergency situations,
such as mass casualty events resulting from natural disasters, mass trauma, disease outbreaks, etc. Further, the
hospital must make adequate provisions to ensure the availability of those supplies when needed.
Supplies must be stored in such a manner to ensure their safety (protection against theft or damage, contamination,
or deterioration), as well as that the storage practices do not violate fire codes or otherwise endanger patients
(storage of flammables, blocking passageways, storage of contaminated or dangerous materials, safe storage
practices for poisons, etc.).
Equipment
In order to ensure an acceptable level of safety and quality, the hospital must identify the equipment required to
meet its patients’ needs for both day-to-day operations and in a likely emergency/disaster situation, such as mass
casualty events resulting from natural disasters, mass trauma, disease outbreaks, internal disasters, etc. In addition,
the hospital must make adequate provisions to ensure the availability and reliability of equipment needed for its
operations and services. Equipment includes both facility equipment, which supports the physical environment of the
hospital (e.g., elevators, generators, air handlers, medical gas systems, air compressors and vacuum systems, etc.)
and medical equipment, which are devices intended to be used for diagnostic, therapeutic or monitoring care
provided to a patient by the hospital (e.g., IV infusion equipment, ventilators, laboratory equipment, surgical
devices, etc.).
All equipment must be inspected and tested for performance and safety before initial use and after major repairs or
upgrades.
All equipment must be inspected, tested, and maintained to ensure their safety, availability and reliability.
Equipment maintenance activities may be conducted using hospital personnel, contracted services, or through a
combination of hospital personnel and contracted services. Individual(s) responsible for overseeing the development,
implementation, and management of equipment maintenance programs and activities must be qualified. The hospital
maintains records of hospital personnel qualifications and is able to demonstrate how it assures all personnel,
including contracted personnel, are qualified.
All equipment maintenance policies, procedures and programs, as well as specific equipment maintenance
inventories, activities and schedules fall under the purview of the hospital’s clinical maintenance personnel, safety
department personnel or other personnel who have been assigned responsibility for equipment maintenance by
hospital leadership.
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Hospitals comply with this regulation when they follow the manufacturer-recommended maintenance activities and
schedule. Hospitals may choose to perform maintenance more frequently than the manufacturer recommends, but
must use the manufacturer-recommended maintenance activities in such cases. When equipment is maintained in
accordance with the manufacturer’s recommendations, the hospital must maintain documentation of those
recommendations and the hospital’s associated maintenance activity for the affected equipment.
Alternate Equipment Management (AEM) Program
A hospital may, under certain conditions, use equipment maintenance activities and frequencies that differ from
those recommended by the manufacturer. Hospitals that choose to employ alternate maintenance activities and/or
schedules must develop, implement, and maintain a documented AEM program to minimize risks to patients and
others in the hospital associated with the use of facility or medical equipment. The AEM program must be based on
generally accepted standards of practice for facility or medical equipment maintenance. An example of guidelines for
a medical equipment medical equipment maintenance program may be found in the American National Standards
Institute/ Association for the Advancement of Medical Instrumentation document: ANSI/AAMI EQ 56:1999/ (R) 2013,
Recommended Practice for a Medical Equipment Management Program. Likewise, an example of guidelines for
physical plant equipment may be found in the American Society for Healthcare Engineering (ASHE) 2009 document:
Maintenance Management for Health Care Facilities. There may be similar documents issued by other nationally
recognized organizations which hospitals might choose to reference.
Decision to Place Equipment in an AEM Program
The determination of whether it is safe to perform facility or medical equipment maintenance without following the
equipment manufacturer recommendations must be made by qualified personnel, regardless of whether they are
hospital employees or contractors.
In the case of medical equipment, a clinical or biomedical technician or engineer would be considered qualified.
Highly specialized or complex equipment may require specialized knowledge or training in order for personnel to be
considered qualified to make a decision to place such equipment in an AEM program.
In the case of facility equipment, a Healthcare Facility Management professional (facility manager, director of
facilities, vice president of facilities) would be considered qualified.
The hospital must maintain records of the qualifications of hospital personnel who make decisions on placing
equipment in an AEM program, and must be able to demonstrate how they assure contracted personnel making such
decisions are qualified.
In determining whether or not to include equipment in an AEM program, and which maintenance strategies to use in
developing maintenance activities and frequencies for particular equipment, the hospital must take into account the
typical health and safety risks associated with the equipment’s use. Note that the risk may vary for the same type of
equipment, depending on the patient care setting within the hospital where it is used.
A hospital is expected to identify any equipment in its AEM program which is “critical equipment,” i.e., biomedical or
physical plant equipment for which there is a risk of serious injury or death to a patient or staff person should the
equipment fail. Surveyors must focus their review of a hospital’s AEM program on critical equipment in that program
and the hospital’s documentation of the factors and evidence it considered in developing an AEM strategy for that
equipment.
Factors for a hospital to consider when evaluating the risks associated with a particular type of equipment include,
but are not limited to:
• How the equipment is used and the likely consequences of equipment failure or malfunction - would
failure or malfunction of the equipment hospital-wide or in a particular setting be likely to cause
harm to a patient or a staff person?
• How serious is the harm likely to be? For example, a slightly miscalibrated scale in an adult internal
medicine outpatient clinic might not present significant risk of harm. However, a miscalibrated scale
in a neonatal intensive care unit could have very serious consequences for patient care.
• How widespread is the harm likely to be? For example, are many patients exposed to the equipment,
resulting in harm due to failure impacting more patients or staff? If harm would be widespread,
even if the harm to each affected individual is not serious, this would be a cause for concern.
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Information, if available, on the manufacturer’s equipment maintenance recommendations, including the rationale
for the manufacturer’s recommendations;
• Maintenance requirements of the equipment:
• Are they simple or complex?
• Are the manufacturer’s instructions and procedures available in the hospital, and if so can the
hospital explain how and why it is modifying the manufacturer’s instructions?
• If the manufacturer’s instructions are not available in the hospital, how does the hospital
assess whether the AEM uses appropriate maintenance strategies?
• How readily can the hospital validate the effectiveness of AEM methods for particular
equipment? For example, can the hospital explain how it ensures there is no reduction in
the quality of the performance of biomedical equipment subjected to alternate maintenance
methods?
• The timely availability of alternate devices or backup systems in the event of equipment
failure or malfunction; and
• Incident history of identical or very similar equipment – is there documented evidence, based
on the experience of the hospital (or its third-party contractor), or on evidence publicly
reported by credible sources outside the hospital, which:
• Provides the number, frequency and nature of previous failures and service requests?
• Indicates use of an AEM strategy does not result in degraded performance of the equipment?
Generally multiple factors must be considered, since different types of equipment present different combinations of
severity of potential harm and likelihood of failure. The hospital is expected to be able to demonstrate to a surveyor
the factors it considered in its risk assessment for equipment placed in its AEM program.
Equipment not Eligible for Placement in the AEM Program:
Some equipment may not be eligible for placement in the AEM program, for one or more of the following reasons:
• Other Federal law (for example, regulations promulgated by another Federal agency) or State law
may require that facility or medical equipment maintenance, inspection and testing be performed
strictly in accordance with the manufacturer’s recommendations, or may establish other, more
stringent maintenance requirements. In these instances, the hospital must comply with these other
Federal or State requirements, but State Surveyors conducting Federal surveys assess compliance
only with the hospital Conditions of Participation (CoPs).
• Other CoPs require adherence to manufacturer’s recommendations and/or set specific standards which
preclude their inclusion in an AEM program. For example:
• The National Fire Protection Association Life Safety Code (LSC) requirements incorporated by
reference at 42 CFR 482.41(b) has some provisions that are pertinent to equipment maintenance,
and compliance with these requirements are assessed on Federal surveys.
Imaging/radiologic equipment, whether used for diagnostic or therapeutic purposes, is governed by 42
CFR Section 482.26(b)(2) and must be maintained per manufacturer’s recommendations.
• The equipment is a medical laser device. It should be noted that for medical lasers the U.S. Food and
Drug Administration requires manufacturers to provide a schedule of maintenance and adequate
instructions for service adjustments and service procedures to purchasers and, at cost, to any other
parties requesting them.
• New equipment for which sufficient maintenance history, either based on the hospital’s own or its
contractor’s records, or available publicly from nationally recognized sources, is not available to
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support a risk-based determination must not be immediately included in the AEM program. New
equipment must be maintained in accordance with manufacturer recommendations until a sufficient
amount of maintenance history has been acquired to determine whether the alteration of
maintenance activities or frequencies would be safe. If a hospital later transitions the equipment to
a risk-based maintenance regimen different than the manufacturers’ recommendations, the hospital
must maintain evidence that it has first evaluated the maintenance track record, risks, and tested
the alternate regimen.
Alternative Maintenance Frequencies or Activities
Maintenance strategies are various methodologies used for determining the most efficient and effective maintenance
activities and frequencies. Manufacturers’ recommendations may be based on one or more such strategies. A
hospital may also use one or more maintenance strategies for its AEM program in order to determine the appropriate
maintenance, inspection, and testing activities and frequencies, based upon the nature of the equipment and the
level of risk it presents to patient or staff health and safety. The risk to patient health and safety that is considered
in developing alternative maintenance strategies must be explained and documented in the AEM program.
In developing AEM maintenance strategies hospitals may rely upon information from a variety of sources, including,
but not limited to: manufacturer recommendations and other materials, nationally recognized expert associations,
and/or the hospital’s (or its third-party contractor’s) own experience. Maintenance strategies may be applied to
groups or to individual pieces of equipment.
The hospital is expected to adhere strictly to the AEM activities or strategies it has developed.
Background Information on Types of Maintenance Strategies
• Preventive Maintenance (Time-based Maintenance) – a maintenance strategy where
maintenance activities are performed at scheduled time intervals to minimize equipment
degradation and reduce instances where there is a loss of performance. Most preventive
maintenance is “interval-based maintenance” performed at fixed time intervals (e.g., annual or
semi-annual), but may also be “metered maintenance” performed according to metered usage of
the equipment (e.g., hours of operation). In either case, the primary focus of preventive
maintenance is reliability, not optimization of cost-effectiveness. Maintenance is performed
systematically, regardless of whether or not it is needed at the time. Example: Replacing a battery
every year, after a set number of uses or after running for a set number of hours, regardless.
• Predictive Maintenance (Condition-based Maintenance) – a maintenance strategy that involves
periodic or continuous equipment condition monitoring to detect the onset of equipment
degradation. This information is used to predict future maintenance requirements and to schedule
maintenance at a time just before equipment experiences a loss of performance. Example:
Replacing a battery one year after the manufacturer’s recommended replacement interval, based on
historical monitoring that has determined the battery capacity does not tend to fall below the
required performance threshold before this extended time.
• Reactive Maintenance (Corrective, Breakdown or Run-to-Failure Maintenance) – a
maintenance strategy based upon a “run it until it breaks” philosophy, where maintenance or
replacement is performed only after equipment fails or experiences a problem. This strategy may be
acceptable for equipment that is disposable or low cost, and presents little or no risk to health and
safety if it fails. Example: Replacing a battery after equipment failure when the equipment has little
negative health and safety consequences associated with a failure and there is a replacement
readily available in supply.
• Reliability-Centered Maintenance – a maintenance strategy that not only considers equipment
condition, but also considers other factors unique to individual pieces of equipment, such as
equipment function, consequences of equipment failure, and the operational environment.
Maintenance is performed to optimize reliability and cost effectiveness. Example: Replacing a
battery in an ambulance defibrillator more frequently than the same model used at a nursing
station, since the one in the ambulance is used more frequently and is charged by an unstable
power supply.
Maintenance Tools
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Tools (e.g., hand tools, test equipment, software, etc.) necessary for performing equipment maintenance must be
available and maintained to ensure that measurements are reliable. Tools used for maintenance are not required to
be those specifically recommended by the manufacturer, but tools utilized must be capable of providing results
equivalent to those required by the equipment manufacturer.
AEM Program Documentation
For each type of equipment subject to the AEM program, there must be documentation indicating:
• The pertinent types and level of risks to patient or staff health and safety;
• Alternate maintenance activities, and the maintenance strategy and any other rationale used to
determine those activities; the differences from the manufacturer’s recommended maintenance
activities are made explicit, unless the hospital is unable to obtain the manufacturer’s maintenance
recommendations, due to the age of the equipment or the manufacturer’s restricting the availability
of its recommendations;
• Alternate maintenance frequencies to be used, if any, and the maintenance strategy and any other
rationale used to determine those frequencies. For equipment identified as presenting a very low
risk to patient or staff safety, it could be acceptable to not set a particular frequency but instead
indicate a less specific approach, for example, an interval range, such as “every 12 – 24 months.” It
could also be acceptable to employ periodic “departmental sweeps” for such very low risk
equipment, where equipment functioning is sampled and operators are polled about its
functionality.
• The date when AEM program maintenance activities were performed and, if applicable, further actions
required/taken; and
• Documentation of any equipment failures (not including failures due to operator error), including
whether there was resulting harm to an individual. (Note: equipment failure that is due to operator
error and which results in an adverse event or near miss must be documented in accordance with
the QAPI CoP, as part of the hospital’s required tracking of patient safety-related incidents.
However, there is no requirement to include operator failures in equipment maintenance
documentation.)
When the hospital has multiple identical equipment items, the documentation may be generic to that type of
equipment, except that documentation of maintenance activities performed must be specific to each item of
equipment.
Evaluating Safety and Effectiveness of the AEM Program
The hospital must have policies and procedures which address the effectiveness of its AEM program. In evaluating
the effectiveness of the AEM program the hospital is expected to address factors including, but not limited to:
• How equipment is evaluated to ensure there is no degradation of performance, particularly for
equipment where such degradation may not be readily apparent to staff using the equipment, e.g.,
miscalibration.
• How incidents of equipment malfunction are investigated, including:
• whether or not the malfunction could have been prevented, and what steps will be taken to prevent
future malfunctions; and
• how a determination is made whether or not the malfunction resulted from the use of an AEM
strategy;
• The process for the removal from service of equipment determined to be unsafe or no longer suitable
for its intended application; and
• The use of performance data to determine if modifications in the AEM program procedures are
required.
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Equipment Inventory
All hospital facility and medical equipment, regardless of whether it is leased or owned, and regardless of whether it
is maintained according to manufacturer recommendations or is in an AEM program, is expected to be listed in an
inventory which includes a record of maintenance activities. For low cost/low risk equipment, such as housekeeping
cleaning equipment, it is acceptable for the inventory to indicate under one item the number of such pieces of
equipment in the hospital, e.g., “15 vacuum cleaners for cleaning patient rooms and common areas.”
If the hospital is using an AEM program, the equipment managed through that program must be readily separately
identifiable as subject to AEM. Critical equipment, whether in an AEM program or not, must also be readily identified
as such.
To facilitate effective management, a well-designed equipment inventory contains the following information for all
equipment included. However, hospitals have the flexibility to demonstrate how alternative means they use are
effective in enabling them to manage their equipment.
• A unique identification number;
• The equipment manufacturer;
• The equipment model number;
• The equipment serial number;
• A description of the equipment;
• The location of the equipment (for equipment generally kept in a fixed location);
• The identity of the department considered to “own” the equipment;
• Identification of the service provider;
• The acceptance date; and
• Any additional information the hospital believes may be useful for proper management of the
equipment.
This standard shall apply to all locations of the hospital, all campuses, and all off-site facilities.
The hospital’s department that is responsible for the hospital’s buildings and equipment (both facility equipment and
patient care equipment) must be evaluated for maintaining the appropriate work environment and related
infrastructure to be safe for all staff, patients and visitors.
Certain areas of the hospital may be required to have external sources responsible for maintaining treatment areas
and the hospital will ensure that these services are provided to provide a safe environment for all staff, patient and
visitors.
The organization leadership shall require that a tobacco-free policy be developed and enforced campus-wide.
Substantial progress toward complete conformity shall be demonstrated over time.
The standards incorporated by reference in this section are approved for incorporation by reference by the Director
of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may inspect a copy
at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and
Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go
to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. If any changes in this
edition of the Code are incorporated by reference, CMS will publish a document in the FEDERAL REGISTER to
announce the changes.
(1)
National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169, www.nfpa.org,
1.617.770.3000.
(i)
NFPA 99, Standards for Health Care Facilities Code of the National Fire Protection Association
99, 2012 edition, issued August 11, 2011.
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(ii)
TIA 12-2 to NFPA 99, issued August 11, 2011.
(iii)
TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv)
TIA 12-4 to NFPA 99, issued March 7, 2013.
(v)
TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi)
TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii)
NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011; (viii) TIA 12-1 to NFPA
101, issued August 11, 2011.
(ix)
TIA 12-2 to NFPA 101, issued October 30, 2012.
(x)
TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi)
TIA 12-4 to NFPA 101, issued October 22, 2013.
(2)
[Reserved]
[51 FR 22042, June 17, 1986, as amended at 53 FR 11509, Apr. 7, 1988; 68 FR 1386, Jan. 10, 2003;
69 FR 49267,
Aug. 11, 2004; 70 FR 15238, Mar. 25, 2005; 71 FR 55340, Sept. 22, 2006; 81 FR 26899, May 4,
2016; 81 FR
42548, June 30, 2016
Surveyor Guidance:
The survey team will delegate one surveyor to review and evaluate the physical environment of the hospital.
However, each surveyor, during their respective review of areas within the hospital, should assess the hospital’s
compliance with the physical environment standards. If warranted, based upon the size and complexity of services
provided, the Life Safety Code may be reviewed and evaluated separately by a qualified surveyor.
Verify that the condition of the hospital is maintained in a manner to assure the safety and wellbeing of patients
(e.g., condition or ceilings, walls, and floors, presence of patient hazards, etc.).
Review the hospital’s routine and preventive maintenance schedules to determine that ongoing maintenance
inspections are performed and that necessary repairs are completed.
Verify that the hospital has developed and implemented a comprehensive plan to ensure that the safety and
wellbeing of patients are assured during emergency situations.
Observe the facility layout and determine if the patient’s needs are met. Toilets, sinks, specialized equipment, etc.
should be accessible.
Interview personnel in charge of facility, supplies and equipment maintenance to verify:
• Supplies are maintained in such a manner as to ensure an acceptable level of safety and quality.
• Supplies are stored as recommended by the manufacturer.
• Supplies are stored in such a manner as not to endanger patient safety
• The hospital has identified supplies and equipment that are likely to be needed in emergency
situation.
• The hospital has made adequate provisions to ensure the availability of those supplies and equipment
when needed.
• Interview equipment users when surveying the various units/departments of the hospital to determine
if equipment failures are occurring and causing problems for patient health or safety.
• Determine if there is a complete inventory of equipment required to meet patient needs, regardless of
ownership.
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• Is critical equipment readily identified?
• If the hospital employs an AEM program, is equipment in this program readily identified?
• Determine if the hospital has documentation of the qualifications (e.g., training certificates,
certifications, degrees, etc.) of hospital personnel responsible for the AEM program (if one is being
used by the hospital) as well as for those performing maintenance.
• Determine if the hospital is able to demonstrate how it assures contractors use qualified personnel.
If the hospital is following the manufacturer-recommended equipment maintenance activities and
frequencies:
• In addition to reviewing maintenance records on equipment observed while inspecting various hospital
locations for multiple compliance assessment purposes, select a sample of equipment from the
hospital’s equipment inventory to determine whether the hospital is following the manufacturer’s
recommendations. Critical equipment which poses a higher risk to patient safety if it were to fail,
such as ventilators, defibrillators, robotic surgery devices, etc. should make up the sample majority.
For the sample selected, determine if:
• The hospital has available manufacturer’s recommendations (e.g., manufacturer’s operation and
maintenance manual, standards, studies, guidance, recall information, service records, etc.);
• Maintenance is being performed in accordance with manufacturer’s recommendations.
If a hospital is using an AEM for some equipment:
• Does the hospital’s inventory include equipment, for example, any diagnostic imaging or therapeutic
radiologic equipment, which is not eligible for AEM?
• Determine if the hospital’s development of alternate maintenance activities and frequencies for
equipment in the AEM program as well as AEM activities are being performed by qualified personnel
• Verify the hospital has documented maintenance activities and frequencies for all equipment included
in the AEM program;
• Verify the hospital is evaluating the safety and effectiveness of the AEM program.
• If there is equipment on the inventory the hospital has identified as having such a very low level of
risk that it has determined it can use a broad interval range or departmental “sweeps,” ask the
hospital for the evidence used to make this determination. Does it seem reasonable?
Select a sample of equipment in the AEM program. The majority of the sample must include critical equipment which
poses a higher risk to patient safety if it were to fail, such as ventilators, defibrillators, robotic surgery devices, etc.
For the sample selected:
• Ask the responsible personnel to explain how the decision was made to place the equipment in an
AEM program. Does the methodology used consider risk factors and make use of available
evidence?
• Ask the responsible personnel to describe the methodology for applying maintenance strategies and
determining alternative maintenance activities or frequencies for the sampled equipment. Can they
readily provide an explanation and point to sources of information they relied upon?
• Determine if maintenance is being performed in accordance with the maintenance activities and
frequencies defined in the AEM program.
• Verify the hospital is evaluating the safety and effectiveness of the AEM maintenance activities for this
equipment and taking corrective actions when needed.
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PE.2 LIFE SAFETY MANAGEMENT SYSTEM
SR.1 Except as otherwise provided in NIAHO® Accreditation Requirements-
SR.1a The hospital must meet the applicable provisions and must proceed in accordance with the
2012 Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2,
TIA 12-3, and TIA 12-4). Outpatient surgical departments must meet the provisions
applicable to Ambulatory Health Care Occupancies, regardless of the number of patients
served.
SR.1b Corridor doors and doors to rooms containing flammable or combustible materials must be
provided with positive latching hardware. Roller latches are prohibited on such doors.
SR.1c In consideration of a recommendation by the State survey agency or Accrediting
Organization or at the discretion of the Secretary, may waive, for periods deemed
appropriate, specific provisions of the Life Safety Code, which would result in unreasonable
hardship upon a hospital, but only if the waiver will not adversely affect the health and
safety of the patients.
SR.1d The provisions of the Life Safety Code do not apply in a State where CMS finds that a fire
and safety code imposed by State law adequately protects patients in hospitals
SR.2 RESERVED
SR.3 The organization shall maintain written evidence of regular inspection and approval by State or local
fire control agencies.
SR.4 The organization must have written fire control plans that contain provisions for prompt reporting of
fires; extinguishing fires; protection of patients, personnel, and guests; evacuation; and cooperation
with firefighting authorities. The fire control plan shall provide for the following (NFPA 101-20 ,
18.7.2.2 & 19.7.2.2):
SR.4a Use of alarms
SR.4b Transmission of alarm to fire department
SR.4c Response to alarms
SR.4d Isolation of fire
SR.4e Evacuation of immediate area
SR.4f Evacuation of smoke compartment
SR.4g Preparation of floors and building for evacuation
SR.4h Extinguishment of fire
SR.5 The Life Safety Management System shall include in the elements of SR.4e a written barrier
protection plan for the preservation of the integrity of hospital smoke and fire barriers. The plan shall
include:
SR.5a Name(s) of Responsible hospital staff for barrier protection program;
SR.5b Requirement for written permission for anyone (including all hospital staff, contractors and
vendors) to penetrate a smoke or fire barrier wall, ceiling or floor;
SR.5c Input from Infection Control and Prevention Practitioner on critical clinical areas prior to
issuance of written permit for performing work on barriers; and
SR.5d Establishment of monitoring process to ensure all work is completed correctly.
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SR.6 Health care occupancies shall conduct unannounced fire drills, but not less than one (1) drill per shift
per calendar quarter that transmits a fire alarm signal and simulates an emergency fire condition.
When fire drills are conducted between 9:00 p.m. (2100 hours) and 6:00 a.m. (0600 hours), a
coded announcement shall be permitted to be used instead of audible alarms. (NFPA 101-2012,
18.7.1.2. & 19.7.1.2).
SR.6a Business occupancies shall conduct at least one unannounced fire drill annually per shift.
SR.6b Fire drills must be thoroughly documented and evaluate the organization’s knowledge to the
items listed in PE.2, SR.4.
SR.6c At least annually, the organization shall evaluate the effectiveness of the fire drills. The
report of effectiveness shall be forwarded to Quality Management oversight.
SR.7 The Life Safety Management System shall address applicable Alterative Life Safety Measures (ALSM)
that shall be implemented whenever life safety features, systems, or processes are impaired or
deficiencies are created or occur. Thorough documentation is required.
SR.7a All alternative life safe measures must be approved by the authority having local
jurisdiction. Life safety measures for redundant and/or common minor
renovations/repairs/testing may be preapproved for the specific task by the AHJ.
SR.8 When a sprinkler system is shut down for more than 10 hours, the hospital must:
SR.8a Evacuate the building or portion of the building affected by the system outage until the
system is back in service, or
SR.8b Establish a fire watch until the system is back in service.
SR.9 Buildings must have an outside window or outside door in every sleeping room, and for any building
constructed after July 5, 2016 the sill height must not exceed 36 inches above the floor. Windows in
atrium walls are considered outside windows for the purposes of this requirement.
SR.9a The sill height requirement does not apply to newborn nurseries and rooms intended for
occupancy for less than 24 hours.
SR.9b The sill height in special nursing care areas of new occupancies must not exceed 60 inches.
SR.10 The Life Safety Management System shall require that Life Safety systems (e.g., fire suppression,
notification, and detection equipment) shall be tested and inspected (including portable systems).
SR.11 The Life Safety Management System shall require a process for reviewing the acquisition of bedding,
draperies, furnishings and decorations for fire safety.
SR.12 All sleeping rooms shall be equipped with an approved, single station smoke alarm.
Note: NFPA 101, 2012 9.6.2.10.1.4: System smoke detectors in accordance with NFPA 72, National Fire Alarm
and Signaling Code, and arranged to function in the same manner as single-station or multiple-
station smoke alarms shall be permitted in lieu of smoke alarms
SR.13 Construction, Repair, and Improvement operations shall involve the following activities:
SR.13a During construction, repairs, or improvement operations, or otherwise affecting the space,
the Guidelines for Design and Construction of Hospitals and Health Care Facilities, 2014
edition, published by the American Institute of Architects shall be consulted for designing
purposes.
SR.13b The organization shall assess, document, and minimize the impact of construction, repairs,
or improvement operations upon occupied area(s). The assessment shall include, but not be
limited to, provisions for infection control, utility requirements, noise, vibration, and
alternative life safety measures (ALSM).
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SR.13c In occupied areas where construction, repairs, or improvement operations occur, all
required means of egress and required fire protection features shall be in place and
continuously maintained or where alternative life safety measures acceptable to the
authority having local jurisdiction are in place. NFPA 241-1996, Standard for Safeguarding
Construction, Alteration, and Demolition Operations shall be referenced in identifying and
implementing alternative life safety measures.
SR.13d All construction, repairs, or improvement operations, shall be in accordance with applicable
NFPA 101-2012 standards, and State and local building and fire codes. Should standards
and codes conflict, the most stringent standard or code shall prevail.
Interpretive Guidelines:
The hospital, regardless of size or number of beds, shall meet the applicable provisions of the 2012 edition of the Life
Safety Code
®
of the National Fire Protection Association for all inpatient care locations, emergency departments, and
outpatient care locations.
Additionally, the hospital must be in compliance with all applicable codes referenced in the Life Safety Code
®
, such
as, NFPA-99: Health Care Facilities.
Note: In order for SR.3 to be applicable, the appropriate supporting documentation must be in place.
The hospital will maintain and update, as necessary, a fire control plan that includes the elements of SR.4. The
hospital will also have supporting documentation to verify the regular inspection and approval by State or local fire
control agencies.
The Life Safety Management System shall:
• Address applicable Alternative Life Safety Measures to be implemented whenever life safety systems,
processes, or deficiencies are created or occur;
• Require that Life Safety systems (e.g., fire alarm and detection equipment) shall be is tested and
inspected (including portable systems);
Require a process for reviewing bedding, draperies, furnishings and decorations for fire safety; and, When
construction, repairs, or improvement operations affect the space where hospital processes are carried out,
the Guidelines for Design and Construction of Hospitals and Health Care Facilities, 2014 edition (or newer revision if
in publication), NFPA 101-2012 standards, and State and local building and fire codes shall be used.
When construction, repairs, or improvement operations impacts occupied areas, the hospital will also make
provisions to include, as appropriate, infection control practices to be followed, utility requirements, and account for
noise and vibration. The hospital may have also implemented appropriate alternative life safety measures which are
required to be approved by the authority having local jurisdiction.
Surveyor Guidance:
When applicable, verify the consideration, assessment, and recommendation for waivers of specific Life Safety
Code® provisions have been handled by the Fire Authority surveyor as part of the Life Safety Code® survey process.
Review and validate the hospital’s written fire control plans to verify they contain the required provisions of the Life
Safety Code® or State law.
Review and verify that hospital staff has a process in place to report all fires as required to State officials.
In the review of respective areas of the hospital, interview staff throughout the facility to verify knowledge of their
role and responsibilities during a fire.
Review and validate the documentation of inspection and approval reports from State and local fire control agencies.
Review and validate that the Life Safety Management System addresses the elements as described within the
Interpretive Guidelines.
The surveyor should validate compliance with the inspection, testing, and maintenance of fire detection, notification,
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and suppression equipment and systems.
Review areas where current construction, repairs, or improvement operations are taking place and validate that the
Guidelines for Design and Construction of Hospitals and Health Care Facilities, NFPA 101-2012 standards, and State
and local building and fire codes are being followed.
If construction, repairs, or improvement operations are taking place and affects occupied areas, verify that the
hospital has made provisions for the respective elements as described in the Interpretive Guidelines (above).
If there is no renovation or construction taking place within the hospital, verify that the hospital follows a process to
follow the Guidelines for Design and Construction of Hospitals and Health Care Facilities, implements alternative life
safety measures and includes the infection control practitioner and has the resources to account for utility
requirements, and eliminating, to the extent possible, noise and vibration.
Validate there was documentation:
• That the means of egress were checked daily.
• That the means of egress were continuously maintained free from obstructions or impediments.
• That an assessment was performed of work relating to the impact on the occupied area(s) shall be conducted
and include provisions for infection control, utility requirements, noise, vibration, and alternate life
safety measures.
That the authority having local jurisdiction approved the alternate life safety measures.
PE.3 SAFETY MANAGEMENT SYSTEM
SR.1 The organization shall provide a Safety Management System that shall maintain safe and adequate
facilities for its services. Diagnostic and therapeutic facilities must be located for the safety of
patients.
SR.2 The Safety Management System shall require that facilities, supplies and equipment be maintained
and ensure an acceptable level of safety and quality. The extent and complexity of facilities shall be
determined by the services offered.
SR.3 The Safety Management System shall require proper ventilation, light and temperature controls in
pharmaceutical, food preparation, and other appropriate areas.
SR.4 The Safety Management System shall require that the organization maintain an environment free of
hazards and manages staff activities to reduce the risk of occupational related illnesses or injuries.
SR.5 The Safety Management System shall require periodic surveillance of the hospital grounds to observe
and correct safety issues that may be identified.
SR.6 The Safety Management System shall address safety recalls and alerts.
SR.7 All eyewashes and emergency showers shall be tested and maintained according to the ANSI
Z358.1-2009 Standard.
SR.8 The hospital must have procedures for the proper routine storage and prompt disposal of trash.
Interpretive Guidelines:
The hospital will maintain safe and adequate facilities that are designed and maintained in accordance with Federal,
State and local laws, regulations and guidelines and reflect the scope and complexity of the services it offers in
accordance with accepted standards of practice.
The Safety Management System will require:
• That facilities, supplies, and equipment be maintained and ensure an acceptable level of safety and
quality;
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• The hospital maintains an environment free of hazards and manages staff activities to reduce the risk
of occupational related illnesses or injuries; and,
• A process for addressing safety recalls and alerts.
The hospital shall require periodic surveillance of the hospital grounds to observe safety issues that may be identified
and make corrective/preventive action(s) as needed.
Surveyor Guidance:
Review and verify that diagnostic, treatment, and other specialized services are provided in areas appropriate for the
service provided.
Review and verify that the physical facilities are large enough and properly equipped for the scope of services
provided and the number of patients served.
Where corrective/preventive action(s) have been taken, review and verify the documentation in place to ensure the
effectiveness of action(s) taken.
PE.4 SECURITY MANAGEMENT SYSTEM
SR.1 The organization shall develop a Security Management System that provides for a secure
environment.
SR.2 The organization shall meet the requirements set forth in NFPA 99, 2012 Chapter 13, Security
Management.
SR.3 The Security Management System shall require that the organization conduct a security vulnerability
assessment (SVA) and shall implement procedures and controls in accordance with the risks
identified by the SVA.
SR.4 The Security Management System shall at a minimum:
SR.4a Provide for identification of patients, employees and others.
SR.4b Address issues related to abduction, elopement, visitors, workplace violence, and
investigation of property losses.
SR.4c Develop a written, comprehensive workplace violence control and prevention program
based on guidelines from national authorities such as the OSHA Publication 3148-04R 2015
Guidelines for Preventing Workplace Violence for Healthcare and Social Workers.
SR.4d Establish emergency security procedures to include all hazard events identified in the SVA.
SR.4e Require vehicular access to emergency service areas.
SR.4f Require a process for reporting and investigating security related issues.
Interpretive Guidelines:
From NFPA 99, 2012, Chapter 13:
13.2
Security Vulnerability Assessment (SVA).
13.2.1
* The health care facility shall conduct a security vulnerability assessment (SVA).
13.2.2
The SVA shall evaluate the potential security risks posed by the physical and operational
environment of the health care facility to all individuals in the facility.
13.2.3
The facility shall implement procedures and controls in accordance with the risks identified by
the SVA.
These include but may not be limited to:
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(1) Provide identification for patients, staff, and other people entering the facility
(2) Control access in and out of security-sensitive areas
(3) Define and implement procedures as follows:
(a) Security incident
(b) Hostage situation
(c) *Bomb (explosive device or threat)
(d) Criminal threat
(e) Labor action
(f) Disorderly conduct
(g) Workplace violence
(h) Restraining order
(i) Prevention of, and response to, infant or pediatric abduction
(j) Situations involving VIPs or the media
(k) Maintenance of access to emergency areas
(l) Civil disturbance
(m) Forensic patients
(n) Patient elopement
(o) Homeland Security advisory system (threat level changes)
(p) Suspicious powder or substance
(q) Use of force policy
(r) Security staffing augmentation
(3)
Provide security at alternate care sites or vacated facilities
(4)
Control vehicular traffic on the facility property
(5)
Protect the facility assets, including property and equipment
(6)
Provide policy for interaction with law enforcement agencies
(7)
Comply with applicable laws, regulations, and standards regarding security management operations
(8)
Educate and train the facility security force to address the following:
(a) Customer service
(b) Use of physical restraints
(c) Use of force
(d) Response criteria
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(e) Fire watch procedures
(f) Lockdown procedures
(g) Emergency notification procedures
(h) Emergency communications procedures
For general information regarding the SVA and premises security, see NFPA 730, Guide for Premises Security.
Elements of a Workplace Violence Prevention Program should include but not limited to:
•
A Clearly Written Company Workplace Violence Policy Statement
•
Establishment of a Threat Assessment Team
•
Hazard Assessments
•
Workplace Hazard Control and Prevention
•
Training and Education
•
Incident Reporting, Investigation, Follow-up and Evaluatio
•
Recordkeeping
Surveyor Guidance:
Review and validate the Security Management System to ensure that it addresses the respective elements as stated
within PE.4, SR.1 – SR.4.
PE.5 HAZARDOUS MATERIAL (HAZMAT) MANAGEMENT SYSTEM
SR.1 The organization shall provide a Hazmat Management System to manage hazardous materials and
waste.
SR.2 The HAZMAT Management System shall provide processes to manage the environment, selection,
handling, storing, transporting, using, and disposing of hazardous materials and waste.
SR.3 The HAZMAT Management System shall provide processes to manage reporting and investigation of
all spills, exposures, and other incidents.
SR.4 The organization monitors staff exposure levels in hazardous environments and report the results of
the monitoring to the QMS.
SR.5 All compressed gas cylinders in service and in storage shall be individually-secured and located to
prevent mechanical shock from falling or being knocked over.
SR.6 In anesthetizing locations, which use alcohol-based skin preparations, have implemented effective
fire risk reductions measures which include:
SR.6a The use of unit dose skin prep solutions.
SR.6b Application of skin prep follows manufacture/supplier instructions and warnings.
SR.6c Sterile towels are used to absorb drips and runs during the application and then removed
from the anesthetizing location prior to draping.
SR.6d Verifying that all of the above has occurred prior to initiating the surgical procedure.
SR.7 A hospital may install alcohol-based hand rub dispensers in its facility if the dispensers are installed
in a manner that adequately protects against inappropriate access.
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Interpretive Guidelines:
The term waste refers to common garbage, hazardous material as well as biohazardous wastes. The storage and
disposal of trash must be in accordance with Federal, State and local laws and regulations (i.e., EPA, OSHA, CDC,
State environmental, health and safety regulations). The Conditions of Participation for Radiology and Nuclear
Medicine Services address handling and storage of radioactive materials.
There must be proper ventilation in at lease the following areas: Areas using ethylene oxide, nitrous oxide,
gluteraldehydes, xylene, pentamidine, or other potentially hazardous substances.
Surveyor Guidance:
Verify that the hospital has developed and implemented policies and processes for the selection, handling, storing,
transporting, using, and disposing of hazardous materials and waste in accordance with Federal, State and local laws
and regulations (e.g. EPA, OSHA, CDC, State environmental, health and safety regulations).
Review and verify that processes are in place for the reporting and investigation of all spills, exposure and other
incidents involving hazardous materials.
Review documents to ensure employee and environmental monitoring is being conducted.
PE.6 EMERGENCY MANAGEMENT SYSTEM
The organization must comply with all applicable Federal, State and local emergency preparedness requirements.
The organization must establish and maintain a comprehensive emergency preparedness program that meets the
requirements of 42 CFR Section 482.15. The organization must use an all- hazards approach to develop and
maintain a comprehensive emergency preparedness program.
SR.1 The organization must provide a comprehensive Emergency Management System to respond to
emergencies in the organization or within the community and region that may impact the
organization’s ability to provide services.
SR.2 The organization shall meet the requirements set forth in NFPA 99 (2012), Chapter 12, Emergency
Management, and the requirements of PE.6, SR.3-5.
SR.3 The organization must develop and implement emergency preparedness policies and procedures
based on the organization’s emergency plan as required by 42 CFR Section 482.15(a), a risk
assessment as required by 42CFR Section 482.15(a)(1), and the organization’s communication plan
as required by 42 CFR Section 482.15(c). The policies and procedures must be reviewed and
updated at least annually. At a minimum, the policies and procedures must address the following:
SR.3a A process for cooperation and collaboration with local, tribal, regional, State, and Federal
emergency preparedness officials’ efforts to maintain an integrated response during a
disaster or emergency, including documentation of the hospital’s efforts to contact such
officials and, when applicable, its participation in collaborative and cooperative planning
efforts.
SR.3b A system to track the location of on-duty staff and sheltered patients in the organization’s
care during an emergency. If on-duty staff and sheltered patients are relocated during the
emergency, the organization must document the specific name and location of the receiving
facility or other location.
SR.3c Decision criteria for the determination of protection in place or evacuation of patients in the
event of a disaster.
SR.3d A means to shelter in place for patients, staff, and volunteers who remain in the facility.
SR.3e Safe evacuation includes consideration of care and treatment needs of evacuees; staff
responsibilities; transportation; identification of evacuation location(s); and primary and
alternate means of communication with external sources of assistance.
SR.3f A system of medical documentation that preserves patient information, protects
confidentiality of patient information, and secures and maintains the availability of records.
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SR.3g The use of volunteers in an emergency and other emergency staffing strategies, including
the process and role for integration of State and Federally designated health care
professionals to address surge needs during an emergency.
SR.3h The role of the organization under a waiver declared by the Secretary, in accordance with
section 1135 of the Social Security Act, in the provision of care and treatment at an
alternate care site identified by emergency management officials.
SR.3i The development and maintenance of an emergency preparedness communication plan that
complies with Federal, State, and local laws. The communication plan must include all of the
requirements of NFPA 99 (2012), Chapter 12, Emergency Management and must also
include:
SR.3i(1) Names and contact information for the following:
(i) Staff,
(ii) Entities providing services under arrangement,
(iii) Patients' physicians,
(iv) Other hospitals,
(v) Volunteers,
(vi) Federal, State, tribal, regional, and local emergency preparedness staff,
and
(vii) Other sources of assistance
SR.3i(2) Primary and alternate means for communicating with the following:
(i) Organization staff.
(ii) Federal, State, tribal, regional, and local emergency management agencies.
SR.3j A means, in the event of an evacuation, to release patient information as permitted under
45 CFR Section 164.510(b)(1)(ii),
SR.3k A means of providing information about the general condition and location of patients under
the facility’s care as permitted under 45 CFR Section 164.510(b)(4).
SR.4 The organization must comply with the conditions of participation set forth in 42 CFR Section
482.15(d)(2)(i) regarding exercises to test the emergency plan:
SR.4a Participate in a full-scale exercise that is community-based or when a community-based
exercise is not accessible, an individual, facility-based. If the hospital experiences an actual
natural or man-made emergency that requires activation of the emergency plan, the
hospital is exempt from engaging in a community-based or individual, facility-based full-
scale exercise for 1 year following the onset of the actual event.
SR.4b Analyze the hospital’s response to and maintain documentation of all drills, table top
exercises, and emergency events, and revise the hospital’s emergency plan, as needed.
SR.5 The organization must comply with the conditions of participation set forth in 42 CFR Section
482.15(e) regarding the implementation of emergency and standby power systems based on the
organization’s emergency plan:
SR.5a The emergency generator must be located in accordance with the location requirements
found in the Health Care Facilities Code (NFPA 99 and Tentative Interim Amendments TIA
12–2, TIA 12–3, TIA 12–4, TIA 12– 5, and TIA 12–6), Life Safety Code (NFPA 101 and
Tentative Interim Amendments TIA 12–1, TIA 12–2, TIA 12–3, and TIA 12–4), and NFPA
110, when a new structure is built or when an existing structure or building is renovated.
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SR.5b The organization must implement the emergency power system inspection, testing, and
maintenance requirements found in the Health Care Facilities Code, NFPA 110, and Life
Safety Code.
SR.5c Organizations that maintain an onsite fuel source to power emergency generators must
have a plan for how it will keep emergency power systems operational during the
emergency, unless it evacuates.
SR.6 If an organization is part of a healthcare system consisting of multiple separately certified
healthcare facilities that elects to have a unified and integrated emergency preparedness program,
the organization may choose to participate in the healthcare system's coordinated emergency
preparedness program. If elected, the unified and integrated emergency preparedness program
must do all of the following:
SR.6a Demonstrate that each separately certified facility within the system actively participated in
the development of the unified and integrated emergency preparedness program.
SR.6b Be developed and maintained in a manner that takes into account each separately certified
facility's unique circumstances, patient populations, and services offered.
SR.6c Demonstrate that each separately certified facility is capable of actively using the unified
and integrated emergency preparedness program and is in compliance with the program.
SR.6d Include a unified and integrated emergency plan that meets the requirements of PE.1 and
42 CFR Section 482.15(a)(2), (3), and (4). The unified and integrated emergency plan must
also be based on and include the following:
SR.4d(i) A documented community-based risk assessment, utilizing an all-hazards approach.
SR.4d(ii) A documented individual facility-based risk assessment for each separately certified
facility within the health system, utilizing an all-hazards approach.
SR.6e Include integrated policies and procedures that meet the requirements set forth in 42 CFE
Section 462.625(b) and a coordinated communication plan, and training and testing
programs that meet the requirements of 42 CFR Section 482.15(c) and (d) (see PE.6 SR.1-
3).
SR.7 If an organization has one or more transplant centers (as defined in 42 CFR Section 482.70):
SR.7a A representative from each transplant center must be included in the development and
maintenance of the organization's emergency preparedness program; and,
SR.7b The organization must develop and maintain mutually agreed upon protocols that address
the duties and responsibilities of the hospital, each transplant center, and the OPO for the
DSA where the hospital is situated, unless the hospital has been granted a waiver to work
with another OPO, during an emergency.
Interpretive Guidelines:
Assuring the safety and wellbeing of patients would include developing and implementing appropriate emergency
preparedness plans and capabilities in accordance with NFPA 99, 2012. The organization must develop and
implement a comprehensive plan to ensure that the safety and wellbeing of patients are assured during emergency
situations.
The organization must coordinate with Federal, State, regional, and local emergency preparedness and health
authorities to identify likely risks for their area (e.g., natural disasters, bioterrorism threats, disruption of utilities
such as water, sewer, electrical communications, fuel; nuclear accidents, industrial accidents, and other likely mass
casualties, etc.) and to develop appropriate responses that will assure the safety and wellbeing of patients. In
addition to or in alignment with the text in NFPA 99, 2012 Chapter 12, the following issues should be considered
when developing the comprehensive emergency plans(s):
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•
The differing needs of each location where the certified hospital operates;
•
The special needs of patient populations treated at the hospital (e.g., patients with psychiatric
diagnosis, patients on special diets, newborns, etc.);
•
Security of patients and walk-in patients;
•
Security of supplies from misappropriation;
•
Pharmaceuticals, food, other supplies and equipment that may be needed during emergency/disaster
situations;
•
Communication to external entities if telephones and computers are not operating or become
overloaded (e.g., ham radio operators, community officials, other healthcare facilities if transfer of
patients is necessary, etc.);
•
Communication among staff within the hospital itself;
•
Qualifications and training needed by personnel, including healthcare staff, security staff, and
maintenance staff, to implement and carry out emergency procedures;
•
Identification, availability and notification of personnel that are needed to implement and carry out the
hospital’s emergency plans;
•
Identification of community resources, including lines of communication and names and contact
information for community emergency preparedness coordinators and responders;
•
Transfer or discharge of patients to home, other healthcare settings, or other hospitals;
•
Transfer of patients with hospital equipment to another hospital or healthcare setting;
•
Methods to evaluate repairs needed and to secure various likely materials and supplies to effectuate
repairs, and,
•
Provisions if gas, water, electricity supply is shut off to the community;
The hospital must provide for a comprehensive Emergency Management System in order to respond to emergencies
in the organization or that occur in the community that impact the hospital’s ability to provide services.
The hospitals must comply with the applicable provisions of the Life Safety Code®, National Fire Protection
Amendments (NFPA) 101, 2012 Edition and applicable references, such as, NFPA-99, 2012: Health Care Facilities,
Chapter 12, Emergency Management.
In order to prepare for such an emergency, the hospital must conduct a hazard vulnerability analysis to identify
potential emergencies or other circumstances that may impact the hospital and the community. The hospital must
maintain documentation that this analysis has been conducted and that the hospital has prioritized activities to
address and prepare for these vulnerabilities.
Emergency management exercises shall be based upon the most probable emergencies or other circumstances that
may impact the hospital and the community.
The organization’s emergency management plan shall be revised based upon the identified opportunities for
improvement.
Surveyor Guidance:
Review and verify that the hospital has developed and implemented a comprehensive plan to ensure that the safety
and wellbeing of patients are assured during emergency situations. This plan must address the elements listed above
within the Interpretive Guidelines.
Review and validate that the hospital has conducted a hazard vulnerability analysis to identify potential emergencies
in the organization and the community. Determine the method used to prioritize and made preparations to address
the potential hazards to the organization and community.
Review and validate:
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•
That the organization has conducted appropriate and timely emergency management exercises.
•
That after-action reports identified opportunities for improvements.
•
That the organization revised its emergency management plan according to the identified
opportunities for improvement.
PE.7 MEDICAL EQUIPMENT MANAGEMENT SYSTEM
SR.1 The organization shall establish a Medical Equipment Management System that provides processes
for the acquisition, safe use, and the appropriate selection of equipment.
SR.2 The Medical Equipment Management System shall address issues related to the organization’s initial
service inspection, the orientation, and the demonstration of use for rental or physician owned
equipment.
SR.3. The Medical Equipment Management System shall address criteria for the selection of equipment.
SR.4 The Medical Equipment Management System shall address incidents related to serious injury or
illness or death (See SMDA 1990).
SR.5 The Medical Equipment Management System shall have a process for reporting and investigating
equipment management problems, failures, and user errors.
SR.6 The Medical Equipment Management System shall address a process for determining timing and
complexity of medical equipment maintenance.
SR.7 The Medical Equipment Management System shall address the process of receiving and responding
to recalls and alerts.
Interpretive Guidelines:
Medical Equipment must be maintained to ensure an acceptable level of safety and quality.
In order to ensure an acceptable level of safety and quality, the hospital must identify the equipment required to
meet its patients’ needs for both day-to-day operations and in a likely emergency/disaster situation, such as mass
casualty events resulting from natural disasters, mass trauma, disease outbreaks, internal disasters, etc. In addition,
the hospital must make adequate provisions to ensure the availability and reliability of equipment needed for its
operations and services. Equipment includes both facility equipment, which supports the physical environment of the
hospital (e.g., elevators, generators, air handlers, medical gas systems, air compressors and vacuum systems, etc.)
and medical equipment, which are devices intended to be used for diagnostic, therapeutic or monitoring care
provided to a patient by the hospital (e.g., IV infusion equipment, ventilators, laboratory equipment, surgical
devices, etc.).
All equipment must be inspected and tested for performance and safety before initial use and after major repairs or
upgrades.
All equipment must be inspected, tested, and maintained to ensure their safety, availability and reliability.
Equipment maintenance activities may be conducted using hospital personnel, contracted services, or through a
combination of hospital personnel and contracted services. Individual(s) responsible for overseeing the development,
implementation, and management of equipment maintenance programs and activities must be qualified. The hospital
maintains records of hospital personnel qualifications and is able to demonstrate how it assures all personnel,
including contracted personnel, are qualified.
All equipment maintenance policies, procedures and programs, as well as specific equipment maintenance
inventories, activities and schedules fall under the purview of the hospital’s clinical maintenance personnel, safety
department personnel or other personnel who have been assigned responsibility for equipment maintenance by
hospital leadership.
Hospitals comply with this regulation when they follow the manufacturer-recommended maintenance activities and
schedule. Hospitals may choose to perform maintenance more frequently than the manufacturer recommends, but
must use the manufacturer-recommended maintenance activities in such cases. When equipment is maintained in
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accordance with the manufacturer’s recommendations, the hospital must maintain documentation of those
recommendations and the hospital’s associated maintenance activity for the affected equipment.
Alternate Equipment Management (AEM) Program
A hospital may, under certain conditions, use equipment maintenance activities and frequencies that differ from
those recommended by the manufacturer. Hospitals that choose to employ alternate maintenance activities and/or
schedules must develop, implement, and maintain a documented AEM program to minimize risks to patients and
others in the hospital associated with the use of facility or medical equipment. The AEM program must be based on
generally accepted standards of practice for facility or medical equipment maintenance.
An example of guidelines for a medical equipment maintenance program may be found in the American National
Standards Institute/ Association for the Advancement of Medical Instrumentation document: ANSI/AAMI EQ
56:1999/ (R) 2013, Recommended Practice for a Medical Equipment Management Program. Likewise, an example of
guidelines for physical plant equipment may be found in the American Society for Healthcare Engineering (ASHE)
2009 document: Maintenance Management for Health Care Facilities. There may be similar documents issued by
other nationally recognized organizations which hospitals might choose to reference.
Decision to Place Equipment in an AEM Program
The determination of whether it is safe to perform facility or medical equipment maintenance without following the
equipment manufacturer recommendations must be made by qualified personnel, regardless of whether they are
hospital employees or contractors.
In the case of medical equipment, a clinical or biomedical technician or engineer would be considered qualified.
Highly specialized or complex equipment may require specialized knowledge or training in order for personnel to be
considered qualified to make a decision to place such equipment in an AEM program.
In the case of facility equipment, a Healthcare Facility Management professional (facility manager, director of
facilities, vice president of facilities) would be considered qualified.
The hospital must maintain records of the qualifications of hospital personnel who make decisions on placing
equipment in an AEM program, and must be able to demonstrate how they assure contracted personnel making such
decisions are qualified.
In determining whether or not to include equipment in an AEM program, and which maintenance strategies to use in
developing maintenance activities and frequencies for particular equipment, the hospital must take into account the
typical health and safety risks associated with the equipment’s use. Note that the risk may vary for the same type of
equipment, depending on the patient care setting within the hospital where it is used.
A hospital is expected to identify any equipment in its AEM program which is “critical equipment,” i.e., biomedical or
physical plant equipment for which there is a risk of serious injury or death to a patient or staff person should the
equipment fail. Surveyors must focus their review of a hospital’s AEM program on critical equipment in that program
and the hospital’s documentation of the factors and evidence it considered in developing an AEM strategy for that
equipment.
Factors for a hospital to consider when evaluating the risks associated with a particular type of equipment include,
but are not limited to:
•
How the equipment is used and the likely consequences of equipment failure or malfunction - would
failure or malfunction of the equipment hospital-wide or in a particular setting be likely to cause
harm to a patient or a staff person?
•
How serious is the harm likely to be? For example, a slightly miscalibrated scale in an adult internal
medicine outpatient clinic might not present significant risk of harm. However, a miscalibrated scale
in a neonatal intensive care unit could have very serious consequences for patient care.
•
How widespread is the harm likely to be? For example, are many patients exposed to the equipment,
resulting in harm due to failure impacting more patients or staff? If harm would be widespread,
even if the harm to each affected individual is not serious, this would be a cause for concern.
•
Information, if available, on the manufacturer’s equipment maintenance recommendations, including
the rationale for the manufacturer’s recommendations;
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Maintenance requirements of the equipment:
•
Are they simple or complex?
•
Are the manufacturer’s instructions and procedures available in the hospital, and if so can the hospital
explain how and why it is modifying the manufacturer’s instructions?
•
If the manufacturer’s instructions are not available in the hospital, how does the hospital assess
whether the AEM uses appropriate maintenance strategies?
•
How readily can the hospital validate the effectiveness of AEM methods for particular equipment? For
example, can the hospital explain how it ensures there is no reduction in the quality of the
performance of biomedical equipment subjected to alternate maintenance methods?
•
The timely availability of alternate devices or backup systems in the event of equipment failure or
malfunction; and
•
Incident history of identical or very similar equipment – is there documented evidence, based on the
experience of the hospital (or its third-party contractor), or on evidence publicly reported by
credible sources outside the hospital, which:
•
Provides the number, frequency and nature of previous failures and service requests?
•
Indicates use of an AEM strategy does not result in degraded performance of the equipment?
Generally multiple factors must be considered, since different types of equipment present different combinations of
severity of potential harm and likelihood of failure. The hospital is expected to be able to demonstrate to a surveyor
the factors it considered in its risk assessment for equipment placed in its AEM program.
Equipment not Eligible for Placement in the AEM Program:
Some equipment may not be eligible for placement in the AEM program, for one or more of the following reasons:
•
Other Federal law (for example, regulations promulgated by another Federal agency) or State law
may require that facility or medical equipment maintenance, inspection and testing be performed
strictly in accordance with the manufacturer’s recommendations, or may establish other, more
stringent maintenance requirements.
•
In these instances, the hospital must comply with these other Federal or State requirements, but
State Surveyors conducting Federal surveys assess compliance only with the hospital Conditions of
Participation (CoPs).
•
Other CoPs require adherence to manufacturer’s recommendations and/or set specific standards which
preclude their inclusion in an AEM program. For example:
•
The National Fire Protection Association Life Safety Code (LSC) requirements incorporated by
reference at 42 CFR 482.41(b) has some provisions that are pertinent to equipment maintenance,
and compliance with these requirements are assessed on Federal surveys.
•
Imaging/radiologic equipment, whether used for diagnostic or therapeutic purposes, is governed by
42 CFR 482.26(b)(2) and must be maintained per manufacturer’s recommendations.
•
The equipment is a medical laser device. It should be noted that for medical lasers the U.S. Food and
Drug Administration requires manufacturers to provide a schedule of maintenance and adequate
instructions for service adjustments and service procedures to purchasers and, at cost, to any other
parties requesting them.
•
New equipment for which sufficient maintenance history, either based on the hospital’s own or its
contractor’s records, or available publicly from nationally recognized sources, is not available to
support a risk-based determination must not be immediately included in the AEM program. New
equipment must be maintained in accordance with manufacturer recommendations until a sufficient
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amount of maintenance history has been acquired to determine whether the alteration of
maintenance activities or frequencies would be safe. If a hospital later transitions the equipment to
a risk-based maintenance regimen different than the manufacturers’ recommendations, the hospital
must maintain evidence that it has first evaluated the maintenance track record, risks, and tested
the alternate regimen.
Alternative Maintenance Frequencies or Activities
Maintenance strategies are various methodologies used for determining the most efficient and effective maintenance
activities and frequencies. Manufacturers’ recommendations may be based on one or more such strategies. A
hospital may also use one or more maintenance strategies for its AEM program in order to determine the appropriate
maintenance, inspection, and testing activities and frequencies, based upon the nature of the equipment and the
level of risk it presents to patient or staff health and safety. The risk to patient health and safety that is considered
in developing alternative maintenance strategies must be explained and documented in the AEM program.
In developing AEM maintenance strategies hospitals may rely upon information from a variety of sources, including,
but not limited to: manufacturer recommendations and other materials, nationally recognized expert associations,
and/or the hospital’s (or its third party contractor’s) own experience. Maintenance strategies may be applied to
groups or to individual pieces of equipment.
The hospital is expected to adhere strictly to the AEM activities or strategies it has developed.
Background Information on Types of Maintenance Strategies
•
Preventive Maintenance (Time-based Maintenance) – a maintenance strategy where
maintenance activities are performed at scheduled time intervals to minimize equipment
degradation and reduce instances where there is a loss of performance. Most preventive
maintenance is “interval-based maintenance” performed at fixed time intervals (e.g., annual or
semi-annual), but may also be “metered maintenance” performed according to metered usage of
the equipment (e.g., hours of operation). In either case, the primary focus of preventive
maintenance is reliability, not optimization of cost-effectiveness. Maintenance is performed
systematically, regardless of whether or not it is needed at the time. Example: Replacing a battery
every year, after a set number of uses or after running for a set number of hours, regardless.
•
Predictive Maintenance (Condition-based Maintenance) – a maintenance strategy that involves
periodic or continuous equipment condition monitoring to detect the onset of equipment
degradation. This information is used to predict future maintenance requirements and to schedule
maintenance at a time just before equipment experiences a loss of performance. Example:
Replacing a battery one year after the manufacturer’s recommended replacement interval, based on
historical monitoring that has determined the battery capacity does not tend to fall below the
required performance threshold before this extended time.
•
Reactive Maintenance (Corrective, Breakdown or Run-to-Failure Maintenance) – a
maintenance strategy based upon a “run it until it breaks” philosophy, where maintenance or
replacement is performed only after equipment fails or experiences a problem. This strategy may be
acceptable for equipment that is disposable or low cost, and presents little or no risk to health and
safety if it fails. Example: Replacing a battery after equipment failure when the equipment has little
negative health and safety consequences associated with a failure and there is a replacement
readily available in supply.
•
Reliability-Centered Maintenance – a maintenance strategy that not only considers equipment
condition, but also considers other factors unique to individual pieces of equipment, such as
equipment function, consequences of equipment failure, and the operational environment.
Maintenance is performed to optimize reliability and cost effectiveness. Example: Replacing a
battery in an ambulance defibrillator more frequently than the same model used at a nursing
station, since the one in the ambulance is used more frequently and is charged by an unstable
power supply.
Maintenance Tools
Tools (e.g., hand tools, test equipment, software, etc.) necessary for performing equipment maintenance must be
available and maintained to ensure that measurements are reliable. Tools used for maintenance are not required to
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be those specifically recommended by the manufacturer, but tools utilized must be capable of providing results
equivalent to those required by the equipment manufacturer.
AEM Program Documentation
For each type of equipment subject to the AEM program, there must be documentation indicating:
•
The pertinent types and level of risks to patient or staff health and safety;
•
Alternate maintenance activities, and the maintenance strategy and any other rationale used to
determine those activities; the differences from the manufacturer’s recommended maintenance
activities are made explicit, unless the hospital is unable to obtain the manufacturer’s maintenance
recommendations, due to the age of the equipment or the manufacturer’s restricting the availability
of its recommendations;
•
Alternate maintenance frequencies to be used, if any, and the maintenance strategy and any other
rationale used to determine those frequencies. For equipment identified as presenting a very low
risk to patient or staff safety, it could be acceptable to not set a particular frequency but instead
indicate a less specific approach, for example, an interval range, such as “every 12 – 24 months.” It
could also be acceptable to employ periodic “departmental sweeps” for such very low risk
equipment, where equipment functioning is sampled and operators are polled about its
functionality.
•
The date when AEM program maintenance activities were performed and, if applicable, further actions
required/taken; and
•
Documentation of any equipment failures (not including failures due to operator error), including
whether there was resulting harm to an individual.) (Note: equipment failure that is due to operator
error and which results in an adverse event or near miss must be documented in accordance with
the QAPI CoP, as part of the hospital’s required tracking of patient safety-related incidents.
However, there is no requirement to include operator failures in equipment maintenance
documentation.)
When the hospital has multiple identical equipment items, the documentation may be generic to that type of
equipment, except that documentation of maintenance activities performed must be specific to each item of
equipment.
Evaluating Safety and Effectiveness of the AEM Program
The hospital must have policies and procedures which address the effectiveness of its AEM program. In evaluating
the effectiveness of the AEM program the hospital is expected to address factors including, but not limited to:
•
How equipment is evaluated to ensure there is no degradation of performance, particularly for
equipment where such degradation may not be readily apparent to staff using the equipment, e.g.,
miscalibration.
•
How incidents of equipment malfunction are investigated, including:
•
Whether or not the malfunction could have been prevented, and what steps will be taken to prevent
future malfunctions; and
•
How a determination is made whether or not the malfunction resulted from the use of an AEM
strategy;
•
The process for the removal from service of equipment determined to be unsafe or no longer suitable
for its intended application; and
•
The use of performance data to determine if modifications in the AEM program procedures are
required.
Equipment Inventory
All hospital facility and medical equipment, regardless of whether it is leased or owned, and regardless of whether it
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is maintained according to manufacturer recommendations or is in an AEM program, is expected to be listed in an
inventory which includes a record of maintenance activities. For low cost/low risk equipment, such as housekeeping
cleaning equipment, it is acceptable for the inventory to indicate under one item the number of such pieces of
equipment in the hospital, e.g., “15 vacuum cleaners for cleaning patient rooms and common areas.”
If the hospital is using an AEM program, the equipment managed through that program must be readily separately
identifiable as subject to AEM. Critical equipment, whether in an AEM program or not, must also be readily identified
as such.
To facilitate effective management, a well-designed equipment inventory contains the following information for all
equipment included. However, hospitals have the flexibility to demonstrate how alternative means they use are
effective in enabling them to manage their equipment:
•
A unique identification number;
•
The equipment manufacturer;
•
The equipment model number;
•
The equipment serial number;
•
A description of the equipment;
•
The location of the equipment (for equipment generally kept in a fixed location);
•
The identity of the department considered to “own” the equipment;
•
Identification of the service provider;
•
The acceptance date; and
•
Any additional information the hospital believes may be useful for proper management of the
equipment
The hospital will develop and implement a Medical Equipment Plan that addresses the following:
•
Issues related to use of demonstration or rental equipment and how appropriate training is provided
to ensure safe operation;
•
Defined criteria for the selection of equipment;
•
The process of reporting and investigating incidents related to serious injury or illness or death (See
SMDA 1990);
•
A process for reporting and investigating equipment management problems, failures, and user errors;
•
A process for determining timing and complexity of medical equipment maintenance; and,
•
A process of receiving and responding to recalls and alerts.
This shall apply to all locations of the hospital, all campuses, and all off-site facilities.
Surveyor Guidance:
Interview personnel in charge of equipment maintenance:
Select a sample of equipment for which the facility uses the manufacturer’s recommendations for maintenance
frequency. Sample selection should be based on:
•
Risk to patient safety from equipment failure (e.g., sample high/medium/low risk).
•
Critical equipment (e.g., life support devices, key resuscitation devices, critical monitoring devices,
equipment used for radiologic imaging etc.) with higher risk should make up the sample majority.
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•
Service Requests (e.g., sample equipment with high service requests)
•
Failure Records (e.g., sample high failure rates)
•
Equipment Usage (e.g., sample high use)
•
Type of Equipment (e.g., sample medical equipment & facility components)
•
Maintenance is being performed in accordance with manufacturer’s recommendations
For the sample selected, review maintenance records to determine if:
•
Maintenance, inspection, and testing records are complete and accurate;
•
Maintenance records include equipment failures and down-time;
•
Equipment failures are corrected (through repair or replacement) in a timely manner;
•
Equipment failure patterns are investigated and addressed.
•
Records contain the qualifications (e.g., training certificates, certifications, degrees, etc.) of hospital
personnel responsible for performing maintenance and/or the hospital is able to demonstrate how
they assure contracted personnel are qualified. In the case of medical equipment, qualified
personnel would be clinical or biomedical technicians or engineers.
•
Records contain documents required to support maintenance activities (e.g., manufacturer’s operation
and maintenance manual, standards, studies, guidance, recall information, service records, etc.)
Review the hospital’s routine and preventive maintenance schedules to determine that ongoing maintenance
inspections are performed and that necessary repairs are completed.
Verify that the hospital has developed and implemented a comprehensive plan to ensure that the safety and
wellbeing of patients are assured during emergency situations.
Observe the facility layout and determine if the patient’s needs are met. Toilets, sinks, specialized equipment, etc.
should be accessible.
Interview personnel in charge of facility, supplies and equipment maintenance to verify:
•
The hospital has identified supplies and equipment that are likely to be needed in emergency
situation.
•
The hospital has made adequate provisions to ensure the availability of those supplies and equipment
when needed.
•
Interview equipment users when surveying the various units/departments of the hospital to determine
if equipment failures are occurring and causing problems for patient health or safety.
•
Determine if there is a complete inventory of equipment required to meet patient needs, regardless of
ownership.
•
Determine if the inventory is periodically reviewed and updated.
•
Is critical equipment readily identified?
•
If the hospital employs an AEM program, is equipment in this program readily identified?
•
Determine if the hospital has documentation of the qualifications (e.g., training certificates,
certifications, degrees, etc.) of hospital personnel responsible for the AEM program (if one is being
used by the hospital) as well as for those performing maintenance.
•
Determine if the hospital is able to demonstrate how it assures contractors use qualified personnel.
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If the hospital is following the manufacturer-recommended equipment maintenance activities and
frequencies:
In addition to reviewing maintenance records on equipment observed while inspecting various hospital locations for
multiple compliance assessment purposes, select a sample of equipment from the hospital’s equipment inventory to
determine whether the hospital is following the manufacturer’s recommendations. Critical equipment, which poses a
higher risk to patient safety if it were to fail, such as ventilators, defibrillators, robotic surgery devices, etc., should
make up the sample majority.
For the sample selected, determine if:
•
The hospital has available manufacturer’s recommendations (e.g., manufacturer’s operation and
maintenance manual, standards, studies, guidance, recall information, service records, etc.);
•
Maintenance is being performed in accordance with manufacturer’s recommendations.
If a hospital is using an AEM for some equipment:
•
Does the hospital’s inventory include equipment, for example, any diagnostic imaging or therapeutic
radiologic equipment, which is not eligible for AEM?
•
Determine if the hospital’s development of alternate maintenance activities and frequencies for
equipment in the AEM program as well as AEM activities are being performed by qualified
personnel.
•
Verify the hospital has documented maintenance activities and frequencies for all equipment included
in the AEM program;
•
Verify the hospital is evaluating the safety and effectiveness of the AEM program.
•
If there is equipment on the inventory the hospital has identified as having such a very low level of
risk that it has determined it can use a broad interval range or departmental “sweeps,” ask the
hospital for the evidence used to make this determination. Does it seem reasonable?
Select a sample of equipment in the AEM program. The majority of the sample must include critical equipment which
poses a higher risk to patient safety if it were to fail, such as ventilators, defibrillators, robotic surgery devices, etc.
For the sample selected:
•
Ask the responsible personnel to explain how the decision was made to place the equipment in an
AEM program. Does the methodology used consider risk factors and make use of available
evidence?
•
Ask the responsible personnel to describe the methodology for applying maintenance strategies and
determining alternative maintenance activities or frequencies for the sampled equipment. Can they
readily provide an explanation and point to sources of information they relied upon?
•
Determine if maintenance is being performed in accordance with the maintenance activities and
frequencies defined in the AEM program.
•
Verify the hospital is evaluating the safety and effectiveness of the AEM maintenance activities for this
equipment and taking corrective actions when needed.
•
If there is equipment on the inventory the hospital has identified as having such a very low level of
risk that it has determined it can use a broad interval range or departmental “sweeps,” ask the
hospital for the evidence used to make this determination. Does it seem reasonable?
PE.8 UTILITY MANAGEMENT SYSTEM
SR.1 The organization shall require a Utility Management System that provides for a safe and efficient
facility that reduces the opportunity for organization-acquired illnesses.
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SR.2 The Utility Management System shall provide for a process to evaluate critical operating
components.
SR.3 The Utility Management System shall develop maintenance, testing, and inspection processes for
critical utilities.
SR.4 The Utility Management System shall contain a process to address medical gas systems and HVAC
systems (e.g., includes areas for negative pressure).
SR.5 The Utility Management System shall provide for emergency processes for utility system failures or
disruptions.
SR.6 The Utility Management System shall provide for reliable emergency power sources with appropriate
maintenance as required. The organization must implement emergency power system inspection and
testing requirements found in the Health Care Facilities Code, NFPA 110, and the Life Safety Code.
SR.7 The Safety Management System shall require proper ventilation, light and temperature controls in
operating rooms, sterile supply rooms, special procedures, isolation and protective isolation rooms,
pharmaceutical, food preparation, and other appropriate areas.
SR.8 There shall be emergency power and lighting in at least the operating, recovery, intensive care,
emergency rooms, and in other areas where invasive procedures are conducted, stairwells, and other
areas identified by the organization (e.g., blood bank refrigerator, etc.). In all other areas not
serviced by the emergency supply source, battery lamps and flashlights shall be available.
SR.8a Emergency lighting standards shall comply with Section 7.9 of Life Safety Code, 101-2012,
and applicable references, such as, NFPA-99, 2012: Health Care Facilities, for emergency
lighting and emergency power.
SR.8b NFPA 99, 2012 6.3.2.2.11 shall apply to existing healthcare facilities and shall be installed
in accordance with NFPA 70, National Electric Code, 2011 edition.
SR.9 There shall be facilities for emergency gas and water supply.
SR.10 All relevant utility systems shall be maintained inspected, and, tested.
Interpretive Guidelines:
The organization must ensure that the condition of the physical plant and overall hospital environment is developed
and maintained in a manner to ensure the safety and wellbeing of patients, visitors, and staff. The hospital will
ensure that routine and preventive maintenance and testing activities are performed as necessary, in accordance
with Federal and State laws, regulations, and guidelines and manufacturer’s recommendations, by establishing
maintenance schedules and conducting ongoing maintenance inspections to identify areas in need of repair.
There should be proper ventilation, light and temperature controls in pharmaceutical, food preparation, and other
appropriate areas.
There must be proper ventilation in at least the following areas:
•
Areas using ethylene oxide, nitrous oxide, gluteraldehydes, xylene, pentamidine, formaldehyde, or
other potentially hazardous substances;
•
Locations where oxygen is transferred from one container to another;
•
Isolation rooms and reverse isolation rooms (both must be in compliance with Federal and State laws,
regulations, and guidelines such as OSHA, CDC, NIH);
•
Pharmaceutical preparation areas (hoods, cabinets);
•
Laboratory locations: and,
•
Anesthetizing locations.
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NFPA 99, 2012 3.3.9* Anesthetizing Location. Any area of a facility that has been designated to be used for the
administration of general anesthesia.
NFPA 99, 2012 A.3.3.9 Anesthetizing Location. Areas used exclusively for sedation are not included in this
definition.
(Note that this definition is applicable only for LSC purposes and does not supersede other guidance that has been
given on anesthesia.)
Temperature, humidity, and airflow in the anesthetizing locations must be maintained within acceptable standards to
inhibit microbial growth, reduce the risk of infection, control odor and promote patient comfort.
Each operating room should have separate temperature control. Acceptable standards such as from the Association
of Operating Room Nurses (AORN) or the Facilities Guidelines Institute (FGI) should be incorporated into hospital
policy.
The hospital will maintain, and regularly test and inspect, emergency power and lighting in at least the operating and
recovery rooms, in other areas where invasive procedures are conducted, intensive care, and emergency rooms,
stairwells, and other areas identified by the organization (e.g. blood bank refrigerator) to comply with the applicable
Life Safety Code (101).
Where areas are not supplied with an emergency supply source, the hospital will make provisions for battery lamps
and flashlights.
The hospital must have systems for emergency gas and water needs to provide care to inpatients and other persons
who may come to the hospital in need of care. This includes making arrangements with local utility companies and
others for the provision of emergency sources of water and gas. The hospital should consider nationally accepted
references or calculations made by qualified staff when determining the need for at least water and gas. For
example, one source for information on water is the Federal Emergency Management Agency (FEMA).
Emergency gas includes fuels such as propane, natural gas, fuel oil, liquefied natural gas, as well as any gases the
hospital uses in the care of patients such as oxygen, nitrogen, nitrous oxide, etc.
The hospital should have a plan to protect these limited emergency supplies, and have a plan for prioritizing their
use until adequate supplies are available. The plan should also address the event of a disruption in supply (e.g.,
disruption to the entire surrounding community).
Guideline for periodic testing intervals:
•
Daily: once a day with a period of time that is as close as possible to 24 hours between actions.
•
Weekly: once a week with a period of time that is as close as possible to 7 days between actions.
•
Monthly: once a month with a period of time that is as close as possible to 30 days between actions.
•
Quarterly: once every three months with a period of time that is as close as possible to 90 days
between actions.
•
Annually: once per year with a period of time that is as close as possible to 365 days between actions.
The organization must meet the applicable provisions and must proceed in accordance with the 2012 National Fire
Protection Association (NFPA) 101- Life Safety Code (LSC), the 2012 edition of the NFPA 99- Health Care Facilities
Code (HCFC) and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.) for emergency
lighting and emergency power.
NFPA 99, 2012 6.3.2.2.11 (One or more battery-powered lighting units shall be provided within locations where deep
sedation and general anesthesia is administered) shall apply to existing facilities.
Surveyor Guidance:
Review and validate the hospital’s Utility Management System to ensure that there is a process in place to provide
for a safe and efficient facility that reduces the opportunity for hospital-acquired illnesses.
Review and validate the condition of the hospital and that it is maintained in a manner to assure the safety and
wellbeing of patients (e.g. condition of ceilings, walls, and floors, presence of patient hazards).
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Review and validate the hospital’s routine and preventive maintenance schedules to determine that ongoing
maintenance inspections are performed and that necessary corrective/preventive action(s) are taken.
Review and verify that the facility layout is appropriate to meet patient’s needs. Toilets, sinks, specialized equipment
should be accessible.
The hospital will maintain, test and inspect their utility systems and have adequate facilities for emergency gas and
water supply, to provide safe care for patients.
Verify that the Utility Management System provides for:
•
A process to evaluate critical operating components;
•
A means of addressing medical gas systems and HVAC systems;
•
A means for providing emergency processes for utility system failures or disruptions; and,
•
A means for providing for reliable emergency power sources with appropriate maintenance.
•
Verify that the quality of the water supply and distribution system has been deemed acceptable for its
intended use (drinking water, irrigation water, lab water, dialysis);
•
Emergency gases have been deemed acceptable and can be adequately supplied as needed; and,
•
Review the system used by hospital staff to determine the hospital’s emergency needs for gas and
water.
•
Verify that the system accounts for not only inpatients, but also staff and other persons who come to
the hospital in need of care during emergencies.
•
Determine the source of emergency gas and water supplies, Review the quantity and availability of
these supplies to the hospital, and that they are available within a short time through period
additional deliveries.
•
Verify that arrangements have been made with utility companies and others for the provision of
emergency sources of critical utilities, such as water and gas.
•
Verify that the utility systems have been tested, inspected and maintained for the safety of patient
care and applicable to the services provided.
Review and verify that adequate lighting is in place in all the patient care areas, and food and medication
preparation areas.
Review and verify that each surgical suite has separate temperature control.
Review and verify that food products are stored under appropriate conditions (e.g. time, temperature, packaging,
location) based on nationally accepted sources such as the United States Department of Agriculture, the Food and
Drug Administration, or other nationally recognized standard.
Review and verify that pharmaceuticals are stored at temperatures recommended by the product manufacturer and
according to hospital policy.
•
Review monitoring records for temperature to ensure that appropriate levels are maintained.
•
Review humidity maintenance records for anesthetizing locations to ensure, if monitoring determined
humidity levels were not within acceptable parameters, that corrective actions were performed in a
timely manner to achieve acceptable levels.
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ORGAN, TISSUE AND EYE PROCUREMENT (TO)
TO.1 PROCESS
SR.1 The organization shall have a process in place for the procurement of organs, tissue, and eyes. The
organization shall have an agreement with at least one tissue bank and one eye bank to cooperate in
the retrieval, processing, preservation, storage and distribution of tissues and eyes, as may be
appropriate to assure that all usable tissues and eyes are obtained from potential donors, insofar as
such an agreement does not interfere with organ procurement;
TO.2 ORGAN PROCUREMENT ORGANIZATION (OPO) WRITTEN AGREEMENT
The organization shall have a written agreement with an OPO designated under 42 CFR §486This agreement shall:
SR.1 Contain procurement protocols that have been approved by the organization’s governing body and
medical staff,
SR.2 Ensure that timely notification is provided to the OPO, or a third party designated by the OPO, for all
individuals whose death is imminent or who have died in the hospital,
SR.3 Ensure communication of the policy for organ, tissue and eye procurement to all appropriate areas of
the organization, in addition to any revisions or modifications under a controlled document,
SR.4 Acknowledge that it is the OPO’s responsibility for the determination of medical suitability for organ
donation, and, in the absence of alternative arrangements by the organization, the OPO determines
medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor
and the notification protocol developed in consultation with the tissue and eye banks identified by
the organization for this purpose.
SR.5 Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed
of its options to donate organs, tissues, or eyes, or to decline to donate. The individual designated by
the hospital to initiate the request to the family must be an organ procurement representative or a
designated requestor. If a designated requestor is responsible for initiating this request, this
individual must have completed a course offered or approved by the OPO that has been designed in
conjunction with the tissue and eye bank community in the methodology for approaching potential
donor families and requesting organ or tissue donation.
SR.6 Ensure that it works cooperatively with the designated OPO, tissue bank and eye bank in educating
staff on donation issues, reviewing death records to improve identification of potential donors, and
maintaining potential donors while necessary testing and placement of potential donated organs,
tissues, and eyes takes place.
Interpretive Guidelines:
The hospital has a process in place for the procurement of organs, tissue, and eyes.
The hospital must have a written agreement with an Organ Procurement Organization (OPO), designated under 42
CFR Part 486. At a minimum, the written agreement must address the following:
•
Procurement protocols approved by the governing body and medical staff and criteria for referral,
including the referrals of all individuals whose death is imminent or who have died in the hospital
and ensure timely notification;
•
Specifications as to how the tissue and/or eye bank will be notified about potential donors using
notification protocols developed by the OPO in consultation with the hospital-designated tissue and
eye bank(s);
•
The OPO’s responsibility for the determination of medical suitability in lieu of any alternative
arrangement with a different tissue and/or eye bank;
•
Provisions for notification of each individual death in a timely manner to the OPO (or designated third
party) in accordance with the terms of the agreement;
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•
Documentation that the designated requestor training program offered by the OPO has been
developed in cooperation with the tissue bank and eye bank designated by the hospital;
•
Procedures that permit the OPO, tissue bank, and eye bank access to the hospital’s death record
information according to a designated schedule, e.g., monthly or quarterly;
•
Policies that confirm that the hospital is not required to perform credentialing reviews for, or grant
privileges to, members of organ recovery teams as long as the OPO sends only “qualified, trained
individuals” to perform organ recovery; and,
•
The interventions the hospital will utilize to maintain potential organ donor patients so that the patient
organs remain viable.
The hospital must implement a mechanism for communication of the policy for organ, tissue and eye procurement to
all appropriate area of the organization, in addition to any revisions or modifications under a controlled document.
Hospitals must notify the OPO of every death or imminent death in the hospital. When death is imminent, the
hospital must notify the OPO both before a potential donor is removed from a ventilator and while the potential
donor’s organs are still viable. The hospital should have a written policy, developed in coordination with the OPO and
approved by the hospital’s medical staff and governing body, to define “imminent death.” The definition for
“imminent death” should strike a balance between the needs of the OPO and the needs of the hospital’s care givers
to continue treatment of a patient until brain death is declared or the patient’s family has made the decision to
withdraw supportive measures. Collaboration between OPOs and hospitals will create a partnership that furthers
donation, while respecting the perspective of hospital staff.
Definition elements: “Imminent death” might include a patient with severe, acute brain injury who:
•
Requires mechanical ventilation;
•
Is in an intensive care unit (ICU) or emergency department; AND,
•
Exhibits clinical findings consistent with a Glasgow Coma Score that is less than or equal to a mutually-
agreedupon threshold or
•
MD/DOs are evaluating a diagnosis of brain death or
•
An MD/DO has ordered that life-sustaining therapies be withdrawn, pursuant to the family’s decision.
Note: A patient with “severe, acute brain injury” is not always a trauma patient. For example, post myocardial
infarction resuscitation may result in a patient with a beating heart and no brain activity.
Definition: “Timely notification” means a hospital must contact the OPO by telephone as soon as possible after an
individual has died, has been placed on a ventilator due to a severe brain injury, or who has been declared brain
dead (ideally within 1 hour). That is, a hospital must notify the OPO while a brain dead or severely brain-injured,
ventilator-dependent individual is still attached to the ventilator and as soon as possible after the death of any other
individual, including a potential non-heart-beating donor. Even if the hospital does not consider an individual who is
not on a ventilator to be a potential donor, the hospital must call the OPO as soon as possible after the death of that
individual has occurred.
The individual designated by the hospital to initiate the request to a family must be an organ procurement
representative, an organizational representative of a tissue or eye bank, or a designated requestor. Any individuals
involved in a request for organ, tissue, and eye donation must be formally trained in the donation request process.
Definition: A “designated requestor” is defined as a hospital-designated individual who has completed a course
offered or approved by the OPO and designed in conjunction with the tissue and eye bank community.
Waivers: A hospital may obtain a waiver of the above requirements from the Secretary under certain specified
conditions. A waiver allows the hospital to have an agreement with an OPO other than the one initially designated by
CMS, if the hospital meets certain conditions specified in section 1138(a)(2)(A) of the Social Security Act.
In addition, the Secretary may review additional criteria described in section 1138(a)(2)(B) of the Act to evaluate the
hospital's request for a waiver.
Section 1138(a)(2)(A) of the Act states that in granting a waiver, the Secretary must determine that the waiver.
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(1)
Is expected to increase organ donations; and
(2)
Will ensure equitable treatment of patients referred for transplants within the service area served by
the designated OPO and within the service area served by the OPO with which the hospital seeks to
enter into an agreement under the waiver.
In making a waiver determination, section 1138(a)(2)(B) of the Act provides that the Secretary may consider,
among other factors:
(1)
Cost-effectiveness;
(2)
Improvements in quality;
(3)
Whether there has been any change in a hospital's designated OPO due to the changes made in
definitions for metropolitan statistical areas; and
(4)
The length and continuity of a hospital's relationship with an OPO other than the hospital's designated
OPO.
Surveyor Guidance:
Verify that the hospital has a written agreement, approved by the governing body, and that it addresses all required
information or if they have obtained a waiver approved by the Secretary.
In a sampling of records, verify that the hospital has implemented its organ procurement policies. Verify that that all
designated requestors have completed the required training.
Verify that the hospital ensures that only OPO, tissue bank, or eye bank staff or designated requestors are
approaching families to ask them to donate.
When possible, interview a hospital-designated requestor regarding his or her approach to donation requests.
Validate that the hospital ensures that all appropriate staff have attended an educational program regarding
donation issues and how to work with the OPO, tissue bank, and eye bank.
Review and verify that there are policies and procedures in place to ensure the coordination between facility staff
and OPO staff in maintaining the potential donor.
Verify that the organ, tissue, and eye procurement program is integrated into QMS oversight.
TO.3 ALTERNATIVE AGREEMENT
In the event the organization has an alternative agreement with a tissue and/or eye bank, this agreement shall:
SR.1 Specify the criteria for referral of all individuals who have died in the organization, and,
SR.2 Acknowledge the OPO’s responsibility for the determination of medical suitability in lieu of any
alternative arrangement with a different tissue and/or eye bank.
Surveyor Guidance:
Verify that the hospital has an agreement with at least one tissue bank and one eye bank that specifies criteria for
referral of all potential tissue and eye donors, or an agreement with an OPO that specifies the tissue bank and eye
bank to which referrals will be made.
Verify that the OPO is responsible for the determination of medical suitability for tissue and eye donation, unless the
hospital has an alternative agreement with a different tissue and/or eye bank.
TO.4 RESPECT FOR PATIENT RIGHTS
SR.1 The organ, tissue and eye procurement policies, procedures and practices shall demonstrate the
respect for individual patient and family rights that reflect their views, religious beliefs and other
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special circumstances that have been communicated by the patient and/or family to the organization
personnel.
TO.5 DOCUMENTATION
Documents and records of organ procurement will be maintained in the manner directed by the OPO.
Surveyor Guidance:
Review a sampling of documents and records regarding organ procurement
TO.6 ORGAN TRANSPLANTATION
If the organization performs organ transplantation, the organization shall:
SR.1 Be a member in the Organ Procurement and Transplantation Network (OPTN), which is established
and operated in accordance with section 372 of the Public Service Act (42. U.S.C 274) and abide by
its rules,
SR.2 Define the term “organ” as to what transplantation is done. The consistency in terms shall apply to
a kidney, liver, heart, lung or pancreas, and,
SR.3 Provide data related to the performance of organ transplantation as requested by the OPTN, the
Scientific Registry of Transplant Recipients and the OPO. The organization shall be required to
provide this data to CMS as requested by the Secretary.
Surveyor Guidance:
If the hospital performs organ transplantation, verify that the hospital is a member in the Organ Procurement and
Transplantation Network (OPTN), and they have defined the term “organ” as to what transplantation is done. The
consistency in terminology shall apply to a kidney, liver, heart, lung or pancreas, and,
Verify by review, the reports submitted by the facility to the OPTN, the Scientific Registry, the OPOs, and any data
submitted to the Department of Health and Human Services per request of the Secretary.
TO.7 TRANSPLANT CANDIDATES
SR.1 The organization shall ensure the appropriate candidates for receipt of transplanted organs have
been screened, matched, and medically cleared prior to receipt of any organs.
SR.2 Candidate information shall be documented, accurate and available at the time of the organ
transplantation.
SR.3 Authority for transplantation shall be co-signed by the patient or designated representative of the
patient and the practitioner(s) performing the transplantation.
Interpretive Guidelines:
The hospital shall ensure that appropriate candidates for receipt of transplanted organs have been screened,
matched, and medically cleared prior to receipt of any organs. The hospital will take all appropriate steps to verify
that this has occurred prior to the transplantation process is started and this has been appropriately communicated
and documented accordingly to the transplantation team.
The hospital will accurately document the time of the organ transplantation. The hospital will take such steps to
ensure that there are no unnecessary delays when this process is initiated.
The hospital will ensure that authority for transplantation is co-signed by the patient or designated representative of
the patient and the practitioner(s) performing the transplantation.
Surveyor Guidance:
In a review of patient records and/or policies and procedures, regarding the transplantation of organs, verify that
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candidates receiving organs are screened, matched, and medically cleared prior to receipt of any organs.
In the review of records or policies and procedures in place, verify that the time of the organ transplantation is
documented as appropriate when this process is initiated and required by policy.
Verify that the hospital ensures that authority for transplantation is co-signed by the patient or designated
representative of the patient and the practitioner(s) performing the transplantation.
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APPENDIX A
SWING BEDS (SB)
A hospital that provides SNF-level services must conform to the additional standards specified in
Appendix A of these NIAHO
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Accreditation Requirements. The requirements of Appendix A are
applicable to residents receiving post-hospital SNF-level services.
SB.1 FACILTY ELIGIBILITY
SB.1 The hospital must meet the following eligibility requirements of 42 CFR Section 482.58(a):
SB.1a The hospital has fewer than 100 hospital beds, excluding beds for newborns and beds in
intensive care type inpatient units (for eligibility of hospitals with distinct parts electing the
optional reimbursement method, see 42 CFR Section 413.24(d)(5);
SB.1b The hospital is located in a rural area. This includes all areas not delineated as “urbanized”
areas by the Census Bureau, based on the most recent census.
SB1c The hospital does not have in effect a 24-hour nursing waiver granted under §488.54(c).
SB.1d The hospital has not had a swing-bed approval terminated within the two years previous to
application.
Interpretive Guidelines:
The swing-bed concept allows a hospital to use their beds interchangeably for either acute-care or post-acute care. A
“swing-bed” is a change in reimbursement status. The patient swings from receiving acute-care services and
reimbursement to receiving skilled nursing (SNF) services and reimbursement. It is not necessary for the patient to
change location in the hospital when the reimbursement status changes, but moving to a different location is
allowed.
A 3-day qualifying stay for the same spell of illness in any hospital is required prior to admission to swing-bed status.
The 3-day qualifying stay does not need to be from the same facility as the swing-bed admission.
Swing beds do not have to be located in a special section of the hospital. The patient does not have to change
locations in the hospital merely because their status changes unless the hospital requires it.
There must be discharge orders changing status from acute care services, appropriate progress notes, discharge
summary, and subsequent admission orders to swing-bed status regardless of whether the patient stays in the same
hospital or transfers to another hospital with swing bed approval. If the patient remains within the hospital, the same
chart can be utilized but the swing-bed section of the chart must be separate, with appropriate admission orders,
progress notes, and supporting documents.
There is no length of stay restriction for any hospital swing-bed patient.
A 3-day qualifying stay for the same spell of illness in any hospital is required prior to
admission to swing- bed status. The 3-day qualifying stay does not need to be from the same
facility as the swing-bed admission.
Swing-bed patients receive a SNF level of care, and the facility is reimbursed for providing a SNF level
of care. However. swing-bed patients are not SNF patients. Swing-bed patients in facilities are considered to be
patients of the facility
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ADMISSION, TRANSFER AND DISCHARGE (TD)
TD.1 TRANSFER AND DISCHARGE REQUIREMENTS
Transfer and discharge includes movement of a resident to a bed outside of the certified facility
whether that bed is in the same physical plant or not. Transfer and discharge does not refer to
movement of a resident to a bed within the same certified facility.
The facility must permit each resident to remain in the facility, and not transfer or discharge the resident
from the facility unless:
SR.1 The transfer or discharge is necessary for the resident’s welfare and the resident’s needs cannot be
met in the facility;
SR.2 The transfer or discharge is appropriate because the resident’s health has improved sufficiently so
the resident no longer needs the services provided by the facility;
SR.3 The safety of individuals in the facility is endangered due to the clinical or behavioral status of the
resident;
SR.4 The health of individuals in the facility would otherwise be endangered;
SR.5 The resident has failed, after reasonable and appropriate notice, to pay for (or to have paid under
Medicare or Medicaid) a stay at the facility. Non-payment applies if the resident does not submit the
necessary paperwork for third party payment or after the third party, including Medicare or Medicaid,
denies the claim and the resident refuses to pay for his or her stay.
SR.5a For a resident who becomes eligible for Medicaid after admission to a facility, the hospital
may charge a resident only allowable charges under Medicaid; or,
SR.6 The facility ceases operations.
SR.7 The facility may not transfer or discharge a resident while an appeal is pending, pursuant to §
431.230 when a resident exercises his or her right to appeal a transfer or discharge notice from the
facility pursuant to § 431.220(a)(3), unless the failure to discharge or transfer would endanger the
health or safety of the resident or other individuals in the facility. The facility must document the
danger that failure to transfer or discharge would pose.
Interpretive Guidelines:
Definition: Transfer and discharge includes movement of a resident to a bed outside of the
certified facility whether that bed is in the same physical plant or not. Transfer and discharge
does not refer to movement of a resident to a bed within the same certified facility.
The intent of the regulation on transfer and discharge provisions is to significantly restrict a
facility’s ability to transfer or discharge a resident once that resident has been admitted to the
facility to prevent dumping of high care or difficult residents. This requirement applies to
transfer or discharges that are initiated by the facility, not by the resident.
If transfer is due to a significant change in the resident’s condition, the facility must conduct
the appropriate assessment, prior to any transfer or discharge to determine if a new care plan
would allow the facility to meet the resident’s needs. If the significant change in the resident’s
condition is an emergency, immediate transfer
should be arranged.
Surveyor Guidance:
During closed record review, determine the reasons for transfer/discharge.
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• Do records document accurate assessments and attempts through care planning to address the
resident’s needs through multidisciplinary interventions, accommodation of individual needs, and
attention to the resident’s customary routine?
• Did the resident’s MD/DO document the record if the resident was transferred/discharged for the sake
of the resident’s welfare and the resident’s needs could not be met in the facility (e.g., a resident
develops an acute condition requiring hospitalization) or the resident’s health improved to the extent
that the transferred/discharged resident no longer needed the services of the facility?
• Did a MD/DO document the record if residents were transferred because the health of individuals in the
facility is endangered?
• Do the records of residents who are transferred/discharged due to safety reasons reflect the process by
which the facility concluded that in each instance transfer or discharge was necessary?
• If the entity to which the resident was discharged is another long-term care facility, evaluate the extent
to which the discharge summary and the resident’s MD/DO justify why the facility could not meet the
needs of this resident.
TD.2 DOCUMENTATION
When the facility transfers or discharges a resident under any of the circumstances specified in TD.1, the facility
must ensure that the transfer or discharge is documented in the resident's medical record and appropriate
information is communicated to the receiving health care institution or provider.
SR.1 Documentation in the resident's medical record must include:
SR.1a The basis for the transfer per TD.1.
SR.1b In the case of paragraph TD.1, SR.1, the specific resident need(s) that cannot be met,
facility attempts to meet the resident needs, and the service available at the receiving
facility to meet the need(s).
The documentation must be made by:
SR.2 The resident’s physician when transfer or discharge is necessary for the resident’s welfare and the
resident’s needs cannot be met in the facility or the resident’s health has improved sufficiently so the
resident no longer needs the services provided by the facility.
SR.3 A physician when transfer or discharge is necessary as the health of individuals in the facility would
otherwise be endangered or the safety of the individuals in the facility is endangered due to the
clinical or behavioral status of the resident.
Interpretive Guidelines:
A physician extender may complete documentation of the transfer/discharge unless prohibited by
State law or facility policy.
TD.3 NOTIFICATION
Notification must be provided prior to transferring or discharging a resident.
The facility must:
SR.1 Notify the resident and the resident’s representative(s) of the transfer or discharge and the reasons
for the move in writing and in a language and manner they understand. The facility must send a
copy of the notice to a representative of the Office of the State Long-Term Care Ombudsman.
SR.2 The written notice specified in TD.1, SR.1 must include the following:
SR.2a The reason for transfer or discharge;
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SR.2b The effective date of transfer or discharge;
SR.2c The location to which the resident is transferred or discharged;
SR.2d A statement of the resident's appeal rights, including the name, address (mailing and
email), and telephone number of the entity which receives such requests; and information
on how to obtain an appeal form and assistance in completing the form and submitting the
appeal hearing request;
SR.2e The name, address (mailing and email) and telephone number of the Office of the State
Long-Term Care Ombudsman;
SR.2f For nursing facility residents with intellectual and developmental disabilities or related
disabilities, the mailing and email address and telephone number of the agency responsible
for the protection and advocacy of individuals with developmental disabilities established
under Part C of the Developmental Disabilities Assistance and Bill of Rights Act of 2000
(Pub. L. 106-402, codified at 42 U.S.C. 15001 et seq.); and,
SR.2g For nursing facility residents with a mental disorder or related disabilities, the mailing and
email address and telephone number of the agency responsible for the protection and
advocacy of individuals with a mental disorder established under the Protection and
Advocacy for Mentally Ill Individuals Act.
SR.3 Record the reasons for the transfer or discharge in the resident’s clinical record in accordance with
TD.1.
SR.4 Timing of the written notice must be made by the facility:
SR.4a As soon as practicable before transfer or discharge when:
SR.4a(1) The safety of individuals in the facility would be endangered (See TD.1, SR.3) ;
SR.4a(2) The health of individuals in the facility would be endangered (See TD.1, SR.4),
SR.4a(3) The resident’s health improves sufficiently to allow a more immediate transfer or
discharge (See TD.1, SR.2),
SR.4a(4) An immediate transfer or discharge is required by the resident’s urgent medical
needs (See TD.1, SR.1); or,
SR.4a(5) A resident has not resided in the facility for 30 days.
SR.4b All other reasons require at least 30 days notice before transfer or discharge.
TD.4 ORIENTATION FOR TRANSFER OR DISCHARGE
SR.1 The facility must provide and document sufficient preparation and orientation to residents to ensure
safe and orderly transfer or discharge from the facility. This orientation must be provided in a form
and manner that the resident can understand.
Interpretive Guidelines:
“Sufficient preparation” means the facility informs the resident where he or she is going and assures safe
transportation. The facility should actively involve the resident and the resident’s family in selecting the new
residence. Some examples of orientation may include trial visits by the resident to a new location; working with
family; and orientingstaff in the receiving facility to the resident’s daily patterns.
Surveyor Guidance:
During resident reviews, check social service notes to see if appropriate referrals have
been made and, if necessary, if resident counseling has occurred.
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TD.5 CHANGE OF ROOM IN COMPOSITE DISTINCT PART
When a room change has been planned for the patient in the facility that is a composite distinct part (as defined
in§483.5(c), will be limited to the patient being moved within the particular building in which the resident resides. If
the resident is to be moved to another building of the distinct part location, the resident must voluntarily agree to
this move within the facility.
TD.6 DISCHARGE SUMMARY
When the facility anticipates discharge a resident must have a discharge summary that includes
SR.1 A recapitulation of the resident’s stay;
SR.2 A final summary of the resident’s status at the time of the discharge that is available for release to
authorized individuals and agencies, with the consent of the resident or their legal representative
SR.3 A post-discharge plan of care that is developed with the participation of the resident and his or her
family, which will assist the resident to adjust to his or her new living environment.
Interpretive Guidelines:
“Post discharge plan of care” means the discharge planning process that includes assessing
continuing care needs and developing a plan designed to ensure that the individual’s needs will be
met after discharge from the facility into the community.
“Adjust to his or her living environment” means that the post discharge plan should describe the
resident’s and family’s preferences for care, how the resident and family will access these
services, and how care should be coordinated if continuing treatment involves multiple care givers.
It should identify specific resident needs after discharge such as personal care, sterile
dressings, and physical therapy, as well as describe resident/care giver education needs to ensure
the resident/care giver is able to meet care needs after discharge.
Surveyor Guidance:
In reviewing records of residents that have been transferred or discharged:
• Is there evidence of discharge planning in the record for residents who had an anticipated
• discharge or those residents to be discharged shortly (e.g., in the next 7-14 days)?
• Do discharge plans address necessary post discharge care?
• Determine what types of pre-discharge preparation and education the facility provides for residents
and their families.
• Review the discharge summaries. Are there information that addresses a pertinent to continuing care
for the resident?
• Is there documentation that the facility aided the resident and his/her family in locating and
coordinating post discharge services?
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PLAN OF CARE (PC)
PC.1 ASSESSMENT
The facility must conduct initially and periodically a comprehensive, accurate, standardized, reproducible assessment
of each resident’s functional capacity.
SR.1 The assessment must include at least the following:
SR.1a Identification and demographic information.
SR.1b Customary routine.
SR.1c Cognitive patterns.
SR.1d Communication.
SR.1e Vision.
SR.1f Mood and behavior patterns.
SR.1g Psychosocial well-being.
SR.1h Physical functioning and structural problems.
SR.1i Continence.
SR.1j Disease diagnoses and health conditions.
SR.1k Dental and nutritional status.
SR.1l Skin condition.
SR.1m Activity pursuit.
SR.1n Medications.
SR.1o Special treatments and procedures.
SR.1p Discharge potential.
SR.1q Documentation of summary information regarding the additional assessment performed
through the resident assessment protocols.
SR.1r Documentation of participation in assessment.
SR.2 Within 14 calendar days after admission, excluding readmissions in which there is no significant
change in the resident’s physical or mental condition, the facility must make a comprehensive
assessment of a resident’s needs through a process of direct observation and communication with
the resident, as well as communication with licensed and non-licensed direct care staff members on
all shifts.
SR.3 A comprehensive assessment of the resident will be completed not less often than once every 12
months.
SR.4 A facility must coordinate assessments with the preadmission screening and resident review
(PASARR) program under Medicaid as noted in §483.20(c) to the maximum extent practicable to
avoid duplicative testing and effort. Coordination includes:
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SR.4a Incorporating the recommendations from the PASARR level II determination and the
PASARR evaluation report into a resident's assessment, care planning, and transitions of
care.
SR.4b Referring all level II residents and all residents with newly evident or possible serious
mental disorder, intellectual disability, or a related condition for level II resident review
upon a significant change in status assessment.
Interpretive Guidelines:
The intent of this regulation is to provide the facility with ongoing assessment information
necessary to develop a care plan, to provide the appropriate care and services for each resident,
and to modify the care plan and care/services based on the resident’s status. The facility is
expected to use resident observation and communication as the primary source of information when
completing the assessment. In addition to direct observation and communication with the resident,
the facility should use a variety of other sources, including communication with licensed and
non-licensed staff members on all shifts and may include discussions with the resident’s MD/DO,
family members, or outside consultants and review of the resident’s record.
The facility is not required to use the resident assessment instrument (RAI) specified by the State that
is required under §483.20(b), or to comply with the requirements for frequency, scope, and number
of assessments prescribed in §413.343(b). §485.645(d)(6)
“Admission” to the facility is defined as an initial stay or a return stay (not a readmission) in
the facility. A “return stay” applies to those residents who are discharged without expectation
that they will return to the facility, but who do return to the facility.
A “readmission” is an expected return to the facility following a temporary absence for
hospitalization, off-site visit or therapeutic leave.
Items in PC.1; SR.1 would include comprehensive assessments of a resident which were done within 14
days of admission; within 14 days of a significant change in the resident’s physical or mental
condition; or done on an annual review. These assessments need to be in the final discharge summary.
PC.2 CARE PLAN
SR.1 The facility must develop a comprehensive care plan for each resident:
SR.1a To meet a resident’s medical, nursing, mental and psychosocial needs
SR.1b That have been identified in the comprehensive assessment.
SR.1c Includes measurable objectives goals
SR.1d Be developed within 7 days after the completion of the comprehensive assessment
SR.1e Prepared by an interdisciplinary team, that includes
SR.1e(1) The attending physician,
SR.1e(2) A registered nurse with responsibility for the resident, and
SR.1e(3) Other appropriate staff in disciplines as determined by the resident’s needs, and,
to the extent practicable,
SR.1e(4) The participation of the resident, the resident’s family or the resident’s legal
representative; and
SR.1e(5) Be periodically reviewed and revised by a team of qualified persons after each
assessment.
SR.2 The care plan must describe the following;
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SR.2a The services that are to be furnished to attain or maintain the resident’s highest practicable
physical, mental, and psychosocial well-being and
SR.2b Any services that would otherwise be required under §483.25 but are not provided due to
the resident’s exercise of rights §483.10, including the right to refuse treatment
SR.3 The resident or his or her legal representative has the right to participate in the development and
implementation of his or her person-centered plan of care, including but not limited to:
SR.3a The right to be informed, in advance, of changes to the plan of care.
SR.4 The services provided or arranged by the facility must
SR.4a Meet professional standards of quality; and
SR.4b Be provided by qualified persons in accordance with each resident’s written plan of care.
Interpretive Guidelines:
The requirements reflect the facility’s responsibility to provide necessary care and services to attain or maintain the
highest practicable physical, mental and psychosocial wellbeing, in accordance with the comprehensive assessment
and plan of care.
“Interdisciplinary” means that professional disciplines, as appropriate, will work together to provide the greatest
benefit to the resident. It does not mean that every goal must have an interdisciplinary approach. The mechanics of
how the interdisciplinary team meets its responsibilities in developing an interdisciplinary care plan (e.g., a face-to-
face meeting, teleconference, written communication) are at the discretion of the facility.
An interdisciplinary team, in conjunction with the resident, resident’s family, surrogate, or representative, as
appropriate, should develop quantifiable objectives for the highest level of functioning the resident may be expected
to attain, based on the comprehensive assessment. The care plan must reflect intermediate steps for each outcome
objective if identification of those steps will enhance the resident’s ability to meet his/her objectives. Facility staff will
use these objectives to follow resident progress. Facilities may, for some residents, need to prioritize needed care.
The MD/DO must participate as part of the interdisciplinary team, and may arrange with the facility for alternative
methods, other than attendance at care planning conferences, of providing his/her input, such as one-to-one
discussions and conference calls. The resident has the right to refuse specific treatments and to select among
treatment options before the care plan is instituted. The facility should encourage residents, surrogates, and
representatives to participate in care planning, including encouraging attendance at care planning conferences if they
so desire
In some cases, a resident may wish to refuse certain services or treatments that professional staff believe may be
indicated to assist the resident in reaching his or her highest practicable level of well-being. Desires of the resident
should be documented in the clinical record.
“Professional standards of quality” means services that are provided according to accepted standards of clinical
practice. Standards may apply to care provided by a particular clinical discipline or in a specific clinical situation or
setting. Standards regarding quality care practices may be published by a professional facility, licensing board,
accreditation body or other regulatory agency. Recommended practices to achieve desired resident outcomes might
also be found in clinical literature.
Surveyor Guidance:
In sampling of resident records, verify
• that the care plan address the needs, strengths and preferences identified in the comprehensive
assessment
• interdisciplinary expertise utilized to develop a plan to improve the resident’s functional abilities
• the care plan oriented toward preventing avoidable declines in functioning or functional levels
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• the care plan evaluated and revised as the resident’s status changes
• If there is resident has refused treatment, does the care plan reflect the facility’s efforts to find
alternative means to address the problem
Validate that schedule care plan meetings are at the best time of the day for residents and their families.
Interview residents to determine if
• facility staff attempt to make the process understandable to the resident/family
• they had concerns or questions about your care and brought them to the attention of facility staff?” If
yes, “What happened as a result?”
• the facility has provided adequate information to the resident so that the resident was able to make an
informed choice regarding treatment.
Review the care plan of new resident to determine if the assessment and care planning is sufficient to meet the
needs of newly admitted residents.
Verify that staff can describe the care, services and expected outcomes of the care they provide.
RESIDENTS RIGHTS (RR)
The resident has a right to a dignified existence, self-determination, and communication with and access to persons
and services inside and outside the facility. A facility must protect and promote the rights of each resident.
RR.1 EXERCISE OF RIGHTS
SR.1 The resident has the right to exercise his or her rights as a resident of the facility and as a citizen or
resident of the United States
SR.2. The resident has the right to be free of interference, coercion, discrimination, and reprisal from the
facility in exercising his or her rights.
SR.3 In the case of a resident adjudged incompetent under the laws of a State by a court of competent
jurisdiction, the rights of the resident devolve to and are exercised by the resident representative
appointed under State law to act on the resident's behalf. The court-appointed resident
representative exercises the resident's rights to the extent judged necessary by a court of
competent jurisdiction, in accordance with State law.
SR.4 In the case of a resident who has not been adjudged incompetent by the State court, any legal-
surrogate designated in accordance with State law may exercise the resident’s rights to the extent
provided by State law.
RR.2 NOTICE OF RIGHTS AND SERVICES
SR.1 The facility must inform the resident both orally and in writing in a language that the resident
understands of his or her rights and all rules and regulations governing resident conduct and
responsibilities during the stay in the facility.
SR.1a The facility must also provide the resident with the notice (if any) of the State developed
under section 1919(e)(6) of the Act. Such notification must be made prior to or upon
admission and during the resident’s stay. Receipt of such information, and any amendments
to it, must be acknowledged in writing;
SR.2 The resident or his or her legal representative has the right
SR.2a Upon an oral or written request, to access all records pertaining to himself or herself
including current clinical records within 24 hours (excluding weekends and holidays); and
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SR.2b After receipt of his or her records for inspection, to purchase at a cost not to exceed the
community standard photocopies of the records or any portions of them upon request and 2
working days advance notice to the facility.
SR.3 The resident or his or her legal representative has the right to be informed of, and participate in his
or her treatment, including but not limited to:
SR.3a The right to be fully informed in advance, of changes to the plan of care.
SR.4 The resident has the right to request, refuse,
and/or discontinue treatment to participate in or
refuse to participate in experimental research.
Interpretive Guidelines:
The intent of this requirement is to assure that each resident knows his or her rights and responsibilities and that the
facility communicates this information prior to or upon admission, during the resident’s stay, and when the facility’s
rules changes.
A facility must promote the exercise of rights for all residents, including those who face barriers such as
communication problems, hearing problems and cognition limits. These rights include the resident’s right to:
• Be informed about what rights and responsibilities the resident has
• Choose a MD/DO
• Participate in decisions about treatment and care planning
• Have privacy and confidentiality
• Work or not work
• Have privacy in sending and receiving mail
• Visit and be visited by others from outside the facility
• Retain and use personal possessions
• Share a room with a spouse
“Total health status” includes functional status, medical care, nursing care, nutritional status, rehabilitation and
restorative potential, activities potential, cognitive status, oral health status, psychosocial status, and sensory and
physical impairments. Information on health status must be presented in language that the resident can understand.
Communicating with the resident in language that the resident can understand includes minimizing the use of
technical words, providing interpreters for non-English speaking residents, using sign language when needed, or
other interventions, as appropriate.
“Treatment” is defined as care provided for purposes of maintaining/restoring health, improving functional level, or
relieving symptoms.
“Experimental research” is defined as development and testing of clinical treatments, such as an investigational drug
or therapy that involve treatment and/or control groups. The resident has the right to refuse to participate in
experimental research. A resident being considered for participation in experimental research must be fully informed
of the nature of the experiment and understand the possible consequences of participating. The opportunity to
refuse to participate in experimental research must occur prior to the start of the research. Aggregated resident
statistics that do not identify individual residents may be used for studies without obtaining resident permission.
“Advance directive” means a written instruction, such as living will or durable power of attorney for health care,
recognized under state law, relating to the provisions of health care when the individual is incapacitated. A resident
who has the capacity to make a health care decision and who withholds consent to treatment or makes an explicit
refusal of treatment either directly or through an advance directive, may not be treated against his/her wishes.
Surveyor Guidance:
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Validate that there are on-going efforts on the part of facility staff to keep residents informed.
Verify that information is communicated in a manner that is understandable to residents.
Verify that information available when it is most useful to the residents such as when they are expressing concerns,
raising questions, and on an on-going basis
Verify the medical record that the patient was informed of his rights, including the right to accept or refuse medical
or surgical treatment
Verify and validate that if the facility participates in any experimental research involving residents, it has an
Institutional Review Board or other committee that reviews and approves research protocols
RR.3 HEALTH CARE DECISIONS
SR.1 The resident has the right to choose a personal attending physician.
SR.2 Be fully informed in advance about care and treatment and of any changes in that care or
treatment that may affect the resident’s well-being.
SR.3 Participate in planning care and treatment or changes in care and treatment.
Interpretive Guidelines:
The right to choose a personal MD/DO does not mean that the MD/DO must serve the resident. If the MD/DO of the
resident’s choosing fails to fulfill a given requirement, such as frequency of MD/DO visits, the facility will have the
right, after informing the resident, to seek alternate MD/DO participation to assure provision of appropriate and
adequate care and treatment.
A facility may not place barriers in the way of residents choosing their own MD/DO. If a resident does not have a
MD/DO, or if the resident’s MD/DO becomes unable or unwilling to continue providing care to the resident, the
facility must assist the resident in exercising his/her choice in finding another MD/DO. A resident can choose his/her
own MD/DO, but cannot have a MD/DO who does not have swing-bed admitting privileges.
The requirement for free choice is met if a resident is allowed to choose a personal MD/DO from among those who
have practice privileges.
“Informed in advance” means that the resident receives information necessary to make a health care decision. The
information should include his/her medical condition, changes in his/her medical condition, the benefits and
reasonable risks of the recommended treatment, and reasonable alternatives. If there are any financial costs to the
resident in the treatment options, they should be disclosed in advance and in writing to the resident prior to his/her
decision.
Unless adjudged incompetent or otherwise found to be incapacitated under the laws of the State, participates in
planning care and treatment” means that the resident is afforded the opportunity to select from alternative
treatments, to the level of his ability to understand. This applies both to initial decisions about care and treatment
and to decisions about changes in care and treatment. The resident has the right to participate in care planning and
to refuse treatment.
Surveyor Guidance:
Validate that if there is a conflict between a resident’s right and the resident’s health or safety, how the facility
attempted to accommodate both the exercise of the resident’s rights and the resident’s health, including exploration
of care alternatives through a thorough care planning process in which the resident may participate.
Determine and validate if a resident whose ability to make decisions about care and treatment is impaired, how he
was kept informed and what was consulted on personal preferences to the level of his ability to understand.
RR.4 ADVANCE DIRECTIVES
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The facility must allow the patient to formulate advance directives and to have facility staff and practitioners comply
with the advance directives in accordance with Federal and State law, rules and regulations.
The facility is permitted to contract with other entities to furnish this information but are still legally responsible for
ensuring that the requirements of RR.4 are met. If an adult individual is incapacitated at the time of admission and is
unable to receive information (due to the incapacitating condition or a mental disorder) or articulate whether or not
he or she has executed an advance directive, facility may give advance directive information to the individual’s
family or surrogate in the same manner that it issues other materials about policies and procedures to the family of
the incapacitated individual or to a surrogate or other concerned persons in accordance with State law. The facility is
not relieved of its obligation to provide this information to the individual once he or she is no longer incapacitated or
unable to receive such information. Follow-up procedures must be in place to provide the information to the
individual directly at the appropriate time.
SR.1 The facility shall document in the patient’s medical record whether or not the patient has executed
an advance directive.
SR.2 The facility shall not condition the provision of care or otherwise discriminate based on the
execution of the advance directive.
SR.3 The facility shall ensure compliance with State law regarding the provision of an advance directive.
SR.4 The facility shall provide education for staff regarding the advance directive.
SR.5 When the advance directive exists and is not in the patient’s medical record, a written policy for
follow-up and compliance shall exist.
Interpretive Guidelines:
ADVANCE DIRECTIVES: Refer to PATIENT RIGHTS – PR.2-ADVANCE DIRECTIVES
Surveyor Guidance:
Refer to PATIENT RIGHTS – PR.2-ADVANCE DIRECTIVES
RR. 5 MEDICAID BENEFITS
Each resident who is entitled to Medicaid benefits, must be informed in writing, at the time of admission to the facility
or, when the resident becomes eligible for Medicaid of:
SR.1 The items and services that are included through facility services under the State plan and for
which the resident may not be charged;
SR.2 Those other items and services that the facility offers and for which the resident may be charged,
and the amount of charges for those services; and,
SR.2a Inform each Medicaid-eligible resident when changes are made to the items and services
specified in RR.5, SR.1 and SR.2 (§483.10(g)(17)(i)(A) and (B)).
SR.3 The facility must inform each resident before, or at the time of admission, and periodically during
the resident’s stay, of services available in the facility and of charges for those services, including
any charges for services not covered under Medicare or by the facilities per diem rate.
Interpretive Guidelines:
If Medicare or Medicaid does not make payment for services, the provider must fully inform the resident of any
related charges both at the time of admission and prior to the time that changes will occur in their bills.
RR.6 PERSONAL PRIVACY AND CONFIDENTIALITY
Each resident has a right to be treated with respect and dignity. Each resident has a right to:
SR.1 Personal privacy and confidentiality of his or her personal and medical records.
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SR.1a Personal privacy includes accommodations, medical treatment, written and telephone
communications, personal care, visits, and meetings of family and resident groups, but this
does not require the facility to provide a private room for each resident.
SR.2 The resident has the right to refuse the release of personal and medical records except as provided
at 42 CFR Section 483.70(i)(2) or other applicable federal or state laws.
SR.2a The facility must allow representatives of the Office of the State Long-Term Care
Ombudsman to examine a resident's medical, social, and administrative records in
accordance with State law.
SR.3 The facility must respect the residents right to personal privacy, including the right to privacy in his
or her oral (that is, spoken), written, and electronic communications, including the right to send
and promptly receive unopened mail and other letters, packages and other materials delivered to
the facility for the resident, including those delivered through a means other than a postal service.
Further, the resident has the right to:
SR.3a Privacy of such communications; and,
SR.3b Access to stationery, postage, and writing implements at the resident's own expense.
SR.4 The facility must provide immediate access to a resident by:
SR.4a Immediate family and other relatives of the resident, subject to the resident's right to deny
or withdraw consent at any time; and,
SR.4b Others who are visiting with the consent of the resident, subject to reasonable clinical and
safety restrictions and the resident's right to deny or withdraw consent at any time.
SR.5 Share a room with his or her spouse when married residents live in the same facility and both
spouses consent to the arrangement.
SR.6 Retain and use personal possessions, including furnishings, and clothing, as space permits, unless
to do so would infringe upon the rights or health and safety of other residents.
Interpretive Guidelines:
The resident has the right to refuse the release of personal and medical records except as provided at §
483.70(i)(2):
The facility must keep confidential all information contained in the resident's records, regardless of the form or
storage method of the records, except when release is:
(i) To the individual, or their resident representative where permitted by applicable law;
(ii) Required by law;
(iii) For treatment, payment, or health care operations, as permitted by and in compliance with 45 CFR
164.506;
(iv) For public health activities, reporting of abuse, neglect, or domestic violence, health oversight activities,
judicial and administrative proceedings, law enforcement purposes, organ donation purposes, research
purposes, or to coroners, medical examiners, funeral directors, and to avert a serious threat to health or
safety as permitted by and in compliance with 45 CFR 164.512.
“Right to personal privacy” means that the resident has the right to privacy with whomever the resident wishes to be
private and that this privacy should include both visual and auditory privacy.
Private space may be created flexibly and need not be dedicated solely for visitation purposes. For example, privacy
for visitation or meetings might be arranged by using a dining area between meals, a vacant chapel, office or room;
or an activities area when activities are not in progress.
Facility staff must examine and treat residents in a manner that maintains the privacy of their bodies. A resident
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must be granted privacy when going to the bathroom and in other activities of personal hygiene. If an individual
requires assistance, authorized staff should respect the individual’s need for privacy. Only authorized staff directly
involved in treatment should be present when treatments are given.
“Promptly” means delivery of mail or other materials to the resident within 24 hours of delivery by the postal service
(including a post office box) and delivery of outgoing mail to the postal service within 24 hours of regularly
scheduled postal delivery and pickup service.
The facility may set reasonable hours for visitation. If it would violate the rights of a roommate to have visitors in
the resident’s room, the facility must establish alternate areas in the facility for visiting. These areas could include
the chapel, a suitable office area, a dining room, or a porch or patio area.
When a room is available for a married couple to share, the facility must permit them to share it if they choose.
All residents’ possessions must be treated with respect and safeguarded.
The facility has the right to limit personal property due to space limitations in the facility or for safety considerations.
Surveyor Guidance:
Document any instances where you observe a resident’s privacy being violated. Completely document how the
resident’s privacy was violated.
Documentation Example: Resident #12 left without gown or bed covers and unattended on 2B Corridor at 3:30
p.m. February 25, 2001. Identify the responsible party, if possible.
If residents’ rooms have few personal possessions, ask residents and families if—
• They are encouraged to have and to use personal items;
• Their personal property is safe in the facility.
RR.7 RESTRAINTS
Refer to PATIENTS RIGHTS;
PR.7 - Restraints and Seclusion;
PR.8 - Restraints and Seclusion: Staff Training Requirements and
PR.9 - Restraints and Seclusion: Report of Death
RR.8 FREEDOM FROM ABUSE, NEGLECT, AND EXPLOITATION
SR.1 The resident has the right to be free from abuse, neglect, misappropriation of resident property,
and exploitation as defined by CMS. This includes but is not limited to freedom from corporal
punishment, involuntary seclusion and any physical or chemical restraint not required to treat the
resident's medical symptoms. The facility must:
SR.1a Not use verbal, mental, sexual, or physical abuse, corporal punishment, or involuntary
seclusion;
SR.1b Ensure that the resident is free from physical or chemical restraints imposed for purposes of
discipline or convenience and that are not required to treat the resident's medical
symptoms. When the use of restraints is indicated, the facility must use the least restrictive
alternative for the least amount of time and document ongoing re-evaluation of the need for
restraints.
SR.2 The facility must develop and implement written policies and procedures that:
SR.2a Prohibit and prevent abuse, neglect, and exploitation of residents and misappropriation of
resident property, and,
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SR.2b Establish policies and procedures to investigate any such allegations.
SR.3 The facility must not employ or otherwise engage individuals who:
SR.3a Have been found guilty of abuse, neglect, exploitation, misappropriation of property, or
mistreatment by a court of law; or,
SR.3b Have had a finding entered into the State nurse aide registry concerning abuse, neglect,
exploitation, mistreatment of residents or misappropriation of their property.
SR.4 The facility must report to the State nurse aide registry or licensing authorities any knowledge it
has of actions by a court of law against an employee, which would indicate unfitness for service as a
nurse aide or other facility staff.
SR.5 In response to allegations of abuse, neglect, exploitation, or mistreatment, the facility must:
SR.5a Ensure that all alleged violations involving abuse, neglect, exploitation or mistreatment,
including injuries of unknown source, and misappropriation of resident property are
reported immediately, but not later than 2 hours after the allegation is made, if the events
that cause the allegation involve abuse or result in serious bodily injury, or not later than 24
hours if the events that cause the allegation do not involve abuse and do not result in
serious bodily injury, to the administrator of the facility and to other officials (including to
the State Survey Agency and adult protective services where state law provides for
jurisdiction in long-term care facilities) in accordance with State law through established
procedures;
SR.5b Have evidence that all alleged violations are thoroughly investigated;
SR.5c Prevent further potential abuse, neglect, exploitation, or mistreatment while the
investigation is in progress; and,
SR.5d Report the results of all investigations to the administrator or his or her designated
representative and to other officials in accordance with State law, including to the State
Survey Agency, within 5 working days of the incident, and if the alleged violation is verified
appropriate corrective action must be taken.
Interpretive Guidelines:
The facility must assure that each resident is free from abuse, corporal punishment, and involuntary seclusion. The
facility is responsible for preventing abuse, but also for those practices and omissions, neglect and misappropriation
of property, which if left unchecked, lead to abuse. Residents must not be subjected to abuse by anyone, including,
but not limited to, facility staff, other residents, consultants or volunteers, staff of other agencies serving the
individual, family members or legal guardians, friends, or other individuals.
Definitions:
• Abuse: the willful infliction of injury, unreasonable confinement, intimidation, or punishment with
resulting physical harm or pain or mental anguish, or deprivation by an individual, including a
caretaker, of goods or services that are necessary to attain or maintain physical, mental, and
psychosocial wellbeing. This presumes that instances of abuse of all residents, even those in a
coma, cause physical harm, or pain or mental anguish.
• Exploitation: taking advantage of a resident for personal gain through the use of manipulation,
intimidation, threats, or coercion.
• Verbal abuse: any use of oral, written or gestured language that willfully includes disparaging and
derogatory terms to residents or their families, or within their hearing distance, regardless of their
age, ability to comprehend, or disability. Examples of verbal abuse include, but are not limited to:
threats of harm; and saying things to frighten a resident, such as telling a resident that she will
never be able to see her family again.
• Sexual abuse: includes, but is not limited to, sexual harassment, sexual coercion, or sexual assault.
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• Physical abuse: includes hitting, slapping, pinching and kicking. It also includes controlling behavior
through corporal punishment and restraints
• Mental abuse: includes, but is not limited to, humiliation, harassment, and threats of punishment or
deprivation.
• Neglect: the failure of the facility, its employees or service providers to provide goods and services to
a resident that are necessary to avoid physical harm, pain, mental anguish, or emotional distress.
• Involuntary seclusion: the separation of a resident from other residents or from his or her room or
confinement to his or her room (with or without roommates) against the resident’s will, or the will
of the resident’s legal representative. Emergency or short term monitored separation from other
residents will not be considered involuntary seclusion and may be permitted if used for a limited
period of time as a therapeutic intervention to reduce agitation until professional staff can develop a
plan of care to meet the resident’s needs.
• Misappropriation of resident’s property: the patterned or deliberate misplacement, exploitation,
or wrongful, temporary or permanent use of a resident’s belongings or money without the resident’s
consent.
In addition to inquiry of the State nurse aide registry or other licensing authorities, the facility should check all staff
references and make reasonable efforts to uncover information about any past criminal prosecutions. “Found
guilty...by a court of law” applies to situations where the defendant pleads guilty, is found guilty, or pleads nolo
contendere.
“Finding” is defined as a determination made by the State that validates allegations of abuse, neglect, mistreatment
of residents or misappropriation of their property. Any facility staff found guilty of neglect, abuse, or mistreating
residents or misappropriation of property by a court of law must have his or her name entered into the nurse aide
registry, or reported to the licensing authority, as appropriate.
Surveyor Guidance:
Request and review any resident complaints. Review of actual incidents and predisposing factors to abuse or neglect
and misappropriation of property.
Determine if there are any residents being temporarily separated from other residents, for less than 24 hours, as an
emergency short-term intervention. Validate the need for the separation to include:
• What are the symptoms that led to the consideration of the separation?
• Are these symptoms caused by failure to:
o Meet individual needs;
o Provide meaningful activities;
o Manipulate the resident’s environment?
• Can the cause(s) be removed?
• If the cause(s) cannot be removed, has the facility attempted to use alternatives short of separation?
• Does the facility use the separation for the least amount of time?
• To what extent has the resident, surrogate or representative participated in care planning and made
an informed choice about separation?
• Does the facility monitor and adjust care to reduce negative outcomes, while continually trying to find
and use less restrictive alternatives?
• If residents are temporarily separated in secured units, staff should carry keys to these units at all
times.
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• If the purpose of the unit is to provide specialized care for residents who are cognitively impaired
(through a program of therapeutic activities designed to enable residents to attain and maintain the
highest practicable physical, mental or psychosocial well-being) then placement in the unit is not in
violation of resident rights, as long as the resident’s individual care plan indicates the need for the
stated purpose and services provided in the unit and the resident, surrogate, or representative has
participated in the placement decision.
Report and record any instances where the survey team observes an abusive incident. Completely document who
committed the abusive act, the nature of the abuse, and where and when it occurred. Ensure that the facility
addresses that incident immediately.
If the survey team’s observations and resident’s responses signal the presence of abuse, determine how the facility
prevents and reports abusive behavior.
Review the policies and procedures regarding abuse prevention: Note particularly the extent to which those policies
concern the areas uncovered through complaints and/or previous survey
Review a sampling of employment applications for questions about convictions or mistreatment, neglect or abuse of
residents, or misappropriation of their property. Determine if applicants have answered these questions and if
affirmative answers had resulted in rejections of employment candidates.
Review and verify the results of any in-house investigations of mistreatment, neglect, or abuse of residents,
misappropriation of their property, or injuries of unknown sources. Determine if:
• Was the administrator notified of the incident and when?
• Did investigations begin promptly after the report of the problem?
• Is there a record of statements or interviews of the resident, suspect (if one is identified), any
eyewitnesses and any circumstantial witnesses?
• Was relevant documentation reviewed and preserved (e.g., dated dressing which was not changed
when treatment recorded change)?
• Was the alleged victim examined promptly (if injury was suspected) and the finding documented in
the report?
• What steps were taken to protect the alleged victim from further abuse (particularly where no suspect
has been identified)?
• What actions were taken as a result of the investigation?
• What corrective action was taken, including informing the nurse aide registry, State licensure
authorities, and other agencies (e.g., long-term care ombudsman; adult protective services;
Medicaid fraud and abuse unit)?
RR.9 WORK
SR.1 The resident has a right to choose to or refuse to perform services for the facility and the facility
must not require a resident to perform services for the facility. The resident may perform services
for the facility, if he or she chooses, when:
SR.1a The facility has documented the need or desire for work in the plan of care;
SR.1b The plan specifies the nature of the services performed and whether the services are
voluntary or paid;
SR.1c Compensation for paid services is at or above prevailing rates; and,
SR.1d The resident agrees to the work arrangement described in the plan of care.
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Interpretive Guidelines:
All resident work, whether of a voluntary or paid nature, must be part of the plan of care.
A resident’s desire for work is subject to medical appropriateness. As part of the plan of care, the resident must
agree to a therapeutic work assignment. The resident also has the right to refuse such treatment at any time that he
or she wishes. At the time of development or review of the plan, voluntary or paid work can be negotiated.
The “prevailing rate” is the wage paid to workers in the community surrounding the facility for the same type,
quality, and quantity of work requiring comparable skills.
Surveyor Guidance:
Determine if any residents engaged in work (e.g., doing housekeeping, doing laundry, preparing meals) and verify if
the plan of care has been updated to reflect this.
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FACILITY SERVICES (FS)
FS.1 PATIENT ACTIVITIES
SR.1 The facility must provide, based on the comprehensive assessment and care plan and the
preferences of each resident, an ongoing program to support residents in their choice of activities,
both facility-sponsored group and individual activities and independent activities, designed to meet
the interests of and support the physical, mental, and psychosocial well-being of each resident,
encouraging both independence and interaction in the community.
SR.2 The activities program must be directed by a qualified professional who is a qualified therapeutic
recreation specialist or an activities professional who:
SR.2a Is licensed or registered, if applicable, by the State in which practicing; and,
SR.2b Is eligible for certification as a therapeutic recreation specialist or as an activities
professional by a recognized accrediting body on or after October 1, 1990; or has 2 years of
experience in a social or recreational program within the last 5 years, 1 of which was full-
time in a therapeutic activities program or;
SR.2c Is a qualified occupational therapist or occupational therapy assistant; or,
SR.2d Has completed a training course approved by the State.
Interpretive Guidelines:
Services may be directed either by a qualified professional meeting the requirements of FS.1, or by an individual on
the facility staff who is designated as the activities director and who serves in consultation with a therapeutic
recreation specialist, occupational therapist, or other professional with experience or education in recreational
therapy.
A “recognized accrediting body” refers to those associations recognized as such by certified therapeutic recreation
specialists or certified activity professionals or registered occupational therapists.
The activities program should be multi-faceted and reflect individual resident’s needs on their care plan. Activities
can occur at any time and are not limited to formal activities being provided by activity staff. Others involved may be
any facility staff, volunteers, and visitors.
Surveyor Guidance:
Observe individual, group and bedside activities.
Verify that residents who are confined or choose to remain in their rooms provided with suitable in-room activities,
Determine if facility staff members assist the resident with activities.
Ascertain that if a resident sit for long periods of time with no apparently meaningful activities what the cause is.
For example:
• The resident’s choice;
• Failure of any staff or volunteers either to inform residents when activities are occurring or to
encourage resident involvement in activities;
• Lack of assistance with ambulation;
• Lack of sufficient supplies and/or staff to facilitate attendance and participation in the activity
programs; or
• Program design that fails to reflect the interests or ability levels of residents, such as activities that
are too complex?
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Interview residents to determine what interests they have, if any of these activities are offered, if not, what other
types of activities are offered that they participate in, if they are encourage to participate,
Review the activity calendar for the month prior to the survey to determine if the formal activity program:
• Reflects the schedules, choices and rights of the residents;
• Offers activities at hours convenient to the residents (e.g., morning, afternoon, some evenings and
weekends);
• Reflects the cultural and religious interests of the resident population; and
• Would appeal to both men and women and all age groups living in the facility.
Review clinical records and activity attendance records of residents to determine if:
• Activities reflect individual resident history indicated by the comprehensive assessment;
• Care plans address activities that are appropriate for each resident based on the comprehensive
assessment;
• Activities occur as planned; and
• Outcomes/responses to activities interventions are identified in the progress notes of each resident.
• If there are problems with provision of activities, determine if qualified staff provide these service.
FS.2 SOCIAL SERVICES
SR.1 The facility must provide medically-related social services to attain or maintain the highest
practicable physical, mental, and psychosocial well-being of each resident.
SR.2 Any facility with more than 120 beds must employ a qualified social worker on a full-time basis.
SR.3 A qualified social worker is an individual with:
SR.3a A minimum of a bachelor’s degree in social work or a bachelor’s degree in a human services
field including but not limited to sociology, gerontology, special education, rehabilitation
counseling, and psychology; and,
SR.3b One year of supervised social work experience in a health care setting working directly with
individuals.
Interpretive Guidelines:
This requirement specifies that facilities aggressively identify the need for medically-related social services, and
pursue the provision of these services. A qualified social worker need not personally provide all of these services. It
is the responsibility of the facility to identify the medically-related social service needs of the resident and assure
that the needs are met by the appropriate discipline.
“Medically-related social services” means services provided by the facility’s staff to assist residents in maintaining or
improving their ability to manage their everyday physical, mental, and psychosocial needs. These services could
include:
• Making arrangements for obtaining needed adaptive equipment, clothing, and personal items;
• Maintaining contact with family (with resident’s permission) to report on changes in health, current
goals, discharge planning, and encouragement to participate in care planning;
• Assisting staff to inform residents and those they designate about the resident’s health status and
health care choices;
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• Making referrals and obtaining services from outside entities (e.g., talking books, absentee ballots,
community wheelchair transportation);
• Assisting residents with financial and legal matters (e.g., applying for pensions, referrals to lawyers,
referrals to funeral homes for preplanning arrangements);
• Discharge planning services (e.g., helping to place a resident on a waiting list for community
congregate living, arranging intake for home care services for residents returning home, assisting
with transfer arrangements to other facilities);
• Providing or arranging provision of needed counseling services;
• Assisting residents to determine how they would like to make decisions about their health care, and
whether or not they would like anyone else to be involved in those decisions;
• Finding options that meet the physical and emotional needs of each resident;
• Meeting the needs of residents who are grieving; and
• Assisting residents with dental/denture care, podiatric care; eye care; hearing services, and obtaining
equipment for mobility or assistive eating devices.
• Where the Medicaid State Plan does not cover needed services, facilities are still required to attempt to
obtain these services.
Surveyor Guidance:
In a sampling of medical records, validate that goal attainment been evaluated and the care plan changed
accordingly and that there is evidence that social services interventions successfully address residents’ needs and
link social supports, physical care, and physical environment with residents’ needs and individuality
When interviewing staff who are responsible for social work, ascertain how they
• monitor the resident’s progress in improving physical, mental and psychosocial functioning.
• established and maintained relationships with the resident’s family or legal representative?
• implement social services interventions to assist the resident in meeting treatment goals
• access services for Medicaid recipients when a Medicaid State Plan does not cover those services?
FS.3 DENTAL SERVICES
SR.1 The facility must assist residents in obtaining routine and 24-hour emergency dental care.
SR.1a The facility must provide or obtain from an outside resource, in accordance with
§483.70(g), routine (to the extent covered under the State plan) and emergency dental
services to meet the needs of each resident.
SR.2 The facility must have a policy identifying those circumstances when the loss or damage of dentures
is the facility's responsibility and may not charge a resident for the loss or damage of dentures
determined in accordance with facility policy to be the facility's responsibility;
SR.3 The facility must promptly, within 3 days, refer residents with lost or damaged dentures for dental
services. If a referral does not occur within 3 days, the facility must provide documentation of what
they did to ensure the resident could still eat and drink adequately while awaiting dental services
and the extenuating circumstances that led to the delay.
SR.4 The facility must assist the resident if necessary or if requested:
SR4a In making appointments; and,
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SR.4b By arranging for transportation to and from the dental services location.
SR.5 The facility may charge a Medicare resident an additional amount for routine and emergency dental
services;
SR.6 The facility must assist residents who are eligible and wish to participate to apply for
reimbursement of dental services as an incurred medical expense under the State plan.
Interpretive Guidelines:
The facility must ensure that a dentist is available for residents. It can satisfy this requirement by employing a staff
dentist or having a contract/arrangement with a dentist to provide services.
For Medicare and private pay residents, facilities are responsible for having the services available, but they may
impose an additional charge for the services. Medicaid residents may not be charged.
For all residents of the facility, if they are unable to pay for needed dental services, the facility should attempt to find
alternative funding sources or alternative service delivery systems so that the resident is able to maintain his/her
highest practicable level of wellbeing.
“Routine dental services” means an annual inspection of the oral cavity for signs of disease, diagnosis of dental
disease, dental radiographs as needed, dental cleaning, fillings (new and repairs), minor dental plate adjustments,
smoothing of broken teeth, and limited prosthodontic procedures (e.g., taking impressions for dentures and fitting
dentures).
“Emergency dental services” includes services needed to treat an episode of acute pain in teeth, gums, or palate;
broken, or otherwise damaged teeth, or any other problem of the oral cavity that requires immediate attention.
“Prompt referral” means, within reason, as soon as the dentures are lost or damaged. Referral does not mean that
the resident must see the dentist at that time, but does mean that an appointment (referral) is made, or that the
facility is aggressively working at replacing the dentures.
Surveyor Guidance:
When interviewing residents, determine if they have problems eating and maintaining nutritional status because of
poor oral health or oral hygiene (missing teeth and may be in need of dentures)
FS.4 SPECIALIZED REHABILITATIVE SERVICES
If specialized rehabilitative services such as, but not limited to, physical therapy, speech-language pathology,
occupational therapy, respiratory therapy, and rehabilitative services for a mental disorder and intellectual disability
or services of a lesser intensity as set forth at 42 CFR Section 483.120(c), are required in the resident’s
comprehensive plan of care, the facility must:
SR.1 Provide the required services; or--
SR.2 In accordance with 42 CFR Section 483.70(g), obtain the required services from an outside
resource that is a provider of specialized rehabilitative services and is not excluded from
participating in any federal or state health care programs pursuant to section 1128 and 1156 of the
Act.
SR.3 Specialized rehabilitative services must be provided under the written order of a MD/DO by qualified
personnel.
Interpretive Guidelines:
The intent of this regulation is to assure that residents receive necessary specialized rehabilitative services as
determined by the comprehensive assessment and care plan, to prevent avoidable physical and mental deterioration
and to assist them in obtaining or maintaining their highest practicable level of functional and psychosocial wellbeing.
Specialized rehabilitative services are considered a facility service and are included within the scope of facility
services. They must be provided to residents who need them even when the services are not specifically enumerated
in the State plan..
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A facility is not obligated to provide specialized rehabilitative services if it does not have residents who require these
services. If a resident develops a need for these services after admission, the facility must either provide the
services, or, where appropriate, obtain the service from an outside resource.
For a resident with mental illness (MI) or mental retardation (MR) to have his or her specialized needs met, the
individual must receive all services necessary to assist the individual in maintaining or achieving as much
independence and self-determination as possible. Specialized services for mental illness or mental retardation refers
to those services to be provided by the State which can only be delivered by personnel or programs other than those
of the nursing facility (NF) because the overall level of NF services is not as intense as necessary to meet the
individual’s needs.
“Mental health rehabilitative services for MI and MR” refers to those services of lesser frequency or intensity to be
implemented by all levels of nursing facility staff who come into contact with the resident who is mentally ill or who
has mental retardation. These services are necessary regardless of whether or not they require additional services to
be provided for or arranged by the State as specialized services.
Mental health rehabilitative services for MI and MR may include, but are not limited to—
• Consistent implementation during the resident’s daily routine and across settings, of systematic plans
that are designed to change inappropriate behaviors;
• Drug therapy and monitoring of the effectiveness and side effects of medications which have been
prescribed to change inappropriate behavior or to alter manifestations of psychiatric illness;
• Provision of a structured environment for those individuals who are determined to need such structure
(e.g., structured socialization activities to diminish tendencies toward isolation and withdrawal);
• Development, maintenance and consistent implementation across settings of those programs
designed to teach individuals the daily living skills they need to be more independent and self-
determining including, but not limited to, grooming, personal hygiene, mobility, nutrition, vocational
skills, health, drug therapy, mental health education, money management, and maintenance of the
living environment;
• Crisis intervention services;
• Individual, group, and family psychotherapy;
• Development of appropriate personal support networks; and
• Formal behavior modification progress.
Determine the extent of follow through with the comprehensive care plan. Verify from the chart that the resident is
receiving frequency and type of therapy as outlined in the care plan.
1. Physical Therapy
• What did the facility do to improve the resident’s muscle strength? The resident’s balance?
• What did the facility do to determine if an assistive device would enable the resident to reach or
maintain his/her highest practicable level of physical function?
• If the resident has an assistive device, is he/she encouraged to use it on a regular basis?
• What did the facility do to increase the amount of physical activity the resident could do (for example,
the number of repetitions of an exercise, the distance walked)?
• What did the facility do to prevent or minimize contractures, which could lead to decreased mobility
and increased risk of pressure ulcer occurrence?
2. Occupational Therapy
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What did the facility do to:
• decrease the amount of assistance needed to perform a task?
• decrease behavioral symptoms?
• improve gross and fine motor coordination?
• improve sensory awareness, visual-spatial awareness, and body integration?
• improve memory, problem solving, attention span, and the ability to recognize safety hazards?
3. Speech, Language Pathology
What did the facility do to:
• improve auditory comprehension?
• improve speech production?
• improve expressive behavior?
• improve the functional abilities of residents with moderate to severe hearing loss who have received
an audiology evaluation?
• For the resident who cannot speak, did the facility assess for a communication board or an alternate
means of communication?
4. Rehabilitative Services For MI And MR
What did the facility do to
• decrease incidents of inappropriate behaviors, for individuals with MR, or behavioral symptoms for
persons with MI? To increase appropriate behavior?
• identify and treat the underlying factors behind tendencies toward isolation and withdrawal?
• develop and maintain necessary daily living skills?
• How has the facility modified the training strategies it uses with its residents to account for the special
learning needs of its residents with MI or MR?
A qualified professional provides specialized rehabilitative services for individuals under a MD/DO’s order. Once the
assessment for specialized rehabilitative services is completed, a care plan must be developed, followed, and
monitored by a licensed professional. Once a resident has met his or her care plan goals, a licensed professional can
either discontinue treatment or initiate a maintenance program which either nursing or restorative aides will follow to
maintain functional and physical status.
“Qualified personnel” means that professional staff are licensed, certified or registered to provide specialized
therapy/rehabilitative services in accordance with applicable State laws. Health rehabilitative services for MI and MR
must be implemented consistently by all staff unless the nature of the services is such that they are designated or
required to be implemented only be licensed or credentialed personnel.
Surveyor Guidance:
Verify that the facility employ professional staff who have experience working directly with or designing training or
treatment programs to meet the needs of individuals with MI or MR.
Determine if there are any problems in quality of care related to maintaining or improving functional abilities.
Determine if these problems are attributable in part to the qualifications of specialized rehabilitative services staff.
Review and verify that the care plan and record that qualified personnel provide rehabilitative services are under the
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written order of a MD/DO.
When interviewing a resident with MI or MR, determine
• Who they talk to when they have a problem or need something?
• What they do when to feel happy? Sad? Can’t sleep at night?
• In what activities are they involved, and how often?
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RESIDENT NUTRITION (RN)
RN.1 NUTRITIONAL STATUS
Using the resident’s comprehensive assessment, the facility must ensure that a resident:
SR.1a Maintains acceptable parameters of nutritional status, such as usual body weight or desirable body
weight range and electrolyte balance, unless the resident's clinical condition demonstrates that this
is not possible or resident preferences indicate otherwise;
SR.1b Is offered sufficient fluid intake to maintain proper hydration and health; and,
SR.1c Is offered a therapeutic diet when there is a nutritional problem and the health care provider orders
a therapeutic diet.
Interpretive Guidelines:
Refer to DIETARY SERVICES (DS)
Parameters of nutritional status that are unacceptable include unplanned weight loss as well as other indices such as
peripheral edema, cachexia and laboratory tests indicating malnourishment (e.g., serum albumin levels).
Weight: Since ideal body weight charts have not yet been validated for the institutionalized elderly, weight loss (or
gain) is a guide in determining nutritional status. An analysis of weight loss or gain should consider the loss or gain
in light of the individual’s former life style as well as the current diagnosis.
Clinical Observations: Potential indicators of malnutrition are pale skin, dull eyes, swollen lips, swollen gums, and
swollen and/or dry tongue with scarlet or magenta hue, poor skin turgor, cachexia, bilateral edema, and muscle
wasting.
Risk factors for malnutrition are—
• Drug therapy that may contribute to nutritional deficiencies such as—
o Cardiac glycosides;
o Diuretics;
o Anti-inflammatory drugs;
o Antacids (antacid overuse);
o Laxatives (laxative overuse);
o Psychotropic drug overuse;
o Anticonvulsants;
o Antineoplastic drugs;
o Phenothiazines;
o Oral hypoglycemics;
• Poor oral health status or hygiene, eyesight, motor coordination, or taste alterations;
• Depression or dementia;
• Therapeutic or mechanically altered diet;
• Lack of access to culturally acceptable foods;
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Slow eating pace resulting in food becoming unpalatable, or in staff removing the tray before resident has finished
eating; and Cancer. Clinical conditions demonstrating that the maintenance of acceptable nutritional status may not
be possible include, but are not limited to—
• Refusal to eat and refusal of other methods of nourishment;
• Advanced disease (i.e., cancer, malabsorption syndrome);
• Increased nutritional/caloric needs associated with pressure sores and wound healing (e.g., fractures,
burns);
• Radiation or chemotherapy;
• Kidney disease, alcohol/drug abuse, chronic blood loss, hyperthyroidism;
• Gastrointestinal surgery; and
• Prolonged nausea, vomiting, diarrhea not relieved by treatment given according to accepted standards
of practice.
“Therapeutic diet” means a diet ordered by a MD/DO as part of treatment for a disease or clinical condition, to
eliminate or decrease certain substances in the diet, (e.g., sodium) or to increase certain substances in the diet
(e.g., potassium), or to provide food the resident is able to eat (e.g., a mechanically altered diet).
Surveyor Guidance:
Verify residents have maintained acceptable parameters of nutritional status. Where indicated by the resident’s
medical status, have clinically appropriate therapeutic diets been prescribed
Verify and determine if residents did not maintain acceptable parameters of nutritional status,
• Did the facility identify factors that put the resident at risk for malnutrition
• What routine preventive measures and care did the resident receive to address unique risk factors for
malnutrition
• where individual goals of the plan of care periodically evaluated and if not met, were alternative
approaches considered or attempted
• Were staff responsibilities for maintaining nutritional status clear, including monitoring the amount of
food the resident is eating at each meal and offering substitutes
• Was this care provided consistently
