SOM Appendix A

State Operations Manual

Appendix A - Survey Protocol,

Regulations and Interpretive Guidelines for Hospitals

Table of Contents

(Rev. 220; Issued:04-19-24)

Transmittals for Appendix A

Survey Protocol

Introduction

Task 1 - Off-Site Survey Preparation

Task 2 - Entrance Activities

Task 3 - Information Gathering/Investigation

Task 4 - Preliminary Decision Making and Analysis of Findings

Task 5 - Exit Conference

Task 6 – Post-Survey Activities

Psychiatric Hospital Survey Module

Psychiatric Unit Survey Module

Rehabilitation Hospital Survey Module

Inpatient Rehabilitation Unit Survey Module

Hospital Swing-Bed Survey Module

Regulations and Interpretive Guidelines

§482.1 Basis and Scope

§482.2 Provision of Emergency Services by Nonparticipating Hospitals

§482.11 Condition of Participation: Compliance with Federal, State and Local Laws

§482.12 Condition of Participation: Governing Body

§482.13 Condition of Participation: Patient's Rights

§482.21 Condition of Participation: Quality Assessment and Performance Improvement

Program

§482.22 Condition of Participation: Medical staff

§482.23 Condition of Participation: Nursing Services

§482.24 Condition of Participation: Medical Record Services

§482.25 Condition of Participation: Pharmaceutical Services

§482.26 Condition of Participation: Radiologic Services

§482.27 Condition of Participation: Laboratory Services

§482.28 Condition of Participation: Food and Dietetic Services

§482.30 Condition of Participation: Utilization Review

§482.41 Condition of Participation: Physical Environment

§482.42 Condition of Participation: Infection Prevention and Control and Antibiotic

Stewardship Programs

§482.43 Condition of Participation: Discharge Planning

§482.45 Condition of Participation: Organ, Tissue and Eye Procurement

§482.51 Condition of Participation: Surgical Services

§482.52 Condition of Participation: Anesthesia Services

§482.53 Condition of Participation: Nuclear Medicine Services

§482.54 Condition of Participation: Outpatient Services

§482.55 Condition of Participation: Emergency Services

§482.56 Condition of Participation: Rehabilitation Services

§482.57 Condition of Participation: Respiratory Services

§482.60 Condition of Participation: Special provisions applying to psychiatric hospitals

§482.61 Condition of Participation: Special medical record requirements for psychiatric

hospitals

§482.62 Condition of Participation: Special staff requirements for psychiatric hospitals

Survey Protocol

Introduction

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

Hospitals are required to be in compliance with the Federal requirements set forth in the

Medicare Conditions of Participation (CoP) in order to receive Medicare/Medicaid

payment. The goal of a hospital survey is to determine if the hospital is in compliance with

the CoP set forth at 42 CFR Part 482. Also, where appropriate, the hospital must be in

compliance with the PPS exclusionary criteria at 42 CFR 412.20 Subpart B and the

swing-bed requirements at 42 CFR 482.66

Certification of hospital compliance with the CoP is accomplished through observations,

interviews, and document/record reviews. The survey process focuses on a hospital’s

performance of patient-focused and organizational functions and processes. The hospital

survey is the means used to assess compliance with Federal health, safety, and quality

standards that will assure that the beneficiary receives safe, quality care and services.

Regulatory and Policy Reference

• The Medicare Conditions of Participation for hospitals are found at 42CFR Part 482.

• Survey authority and compliance regulations can be found at 42 CFR Part 488

Subpart A.

• Should an individual or entity (hospital) refuse to allow immediate access upon

reasonable request to either a State Agency or CMS surveyor, the Office of the

Inspector General (OIG) may exclude the hospital from participation in all Federal

healthcare programs in accordance with 42 CFR 1001.1301.

• The regulatory authority for the photocopying of records and information during the

survey is found at 42 CFR 489.53(a)(13).

• The CMS State Operations Manual (SOM) provides CMS policy regarding survey

and certification activities.

Surveyors assess the hospital’s compliance with the CoP for all services, areas and

locations in which the provider receives reimbursement for patient care services billed

under its provider number.

Although the survey generally occurs during daytime working hours (Monday through

Friday), surveyors may conduct the survey at other times. This may include weekends and

times outside of normal daytime (Monday through Friday) working hours. When the

survey begins at times outside of normal work times, the survey team modifies the survey,

if needed, in recognition of patients’ activities and the staff available.

All hospital surveys are unannounced. Do not provide hospitals with advance notice of the

survey.

Tasks in the Survey Protocol

Listed below, and discussed in this document, are the tasks that comprise the survey

protocol for hospital.

Task 1

Off-Site Survey Preparation

Task 2

Entrance Activities

Task 3

Information Gathering/ Investigation

Task 4

Preliminary Decision Making and Analysis of Findings

Task 5

Exit Conference

Task 6

Post-Survey Activities

Survey Modules for Specialized Hospital Services

The modules for PPS-exempt units (psychiatric and rehabilitation), psychiatric hospitals,

rehabilitation hospitals and swing-bed hospitals are attached to this document. The survey

team is expected to use all the modules that apply to the hospital being surveyed. For

example, if the hospital has swing-beds, a PPS excluded rehabilitation unit, and a PPS

excluded psychiatric unit, the team will use those three modules in addition to this protocol

to conduct the survey. If the hospital is a rehabilitation hospital, the team will use the

rehabilitation hospital module in addition to this protocol to conduct the survey. If the

hospital is a psychiatric hospital and if the survey team will be assessing the hospital’s

compliance with both the hospital CoPs and psychiatric hospital special conditions, the

team will use the psychiatric hospital module in addition to this protocol to conduct the

survey.

Survey Team

Size and Composition

The SA (or the RO for Federal teams) decides the composition and size of the team. In

general, a suggested survey team for a full survey of a mid-size hospital would include two-

four surveyors who will be at the facility for 3 or more days. Each hospital survey team

should include at least one RN with hospital survey experience, as well as other surveyors

who have the expertise needed to determine whether the facility is in compliance. Survey

team size and composition are normally based on the following factors:

• Size of the facility to be surveyed, based on average daily census;

• Complexity of services offered, including outpatient services;

• Type of survey to be conducted;

• Whether the facility has special care units or off-site clinics or locations;

• Whether the facility has a historical pattern of serious deficiencies or complaints;

and

• Whether new surveyors are to accompany a team as part of their training.

Training for Hospital Surveyors

Hospital surveyors should have the necessary training and experience to conduct a hospital

survey. Attendance at a Basic Hospital Surveyor Training Course is suggested. New

surveyors may accompany the team as part of their training prior to completing the Basic

Hospital Surveyor Training Course.

Team Coordinator

The survey is conducted under the leadership of a team coordinator. The SA (or the RO for

Federal teams) should designate the team coordinator. The team coordinator is responsible

for assuring that all survey preparation and survey activities are completed within the

specified time frames and in a manner consistent with this protocol, SOM, and SA

procedures. Responsibilities of the team coordinator include:

• Scheduling the date and time of survey activities;

• Acting as the spokesperson for the team;

• Assigning staff to areas of the hospital or tasks for the survey;

• Facilitating time management;

• Encouraging on-going communication among team members;

• Evaluating team progress and coordinating daily team meetings;

• Coordinating any ongoing conferences with hospital leadership (as determined

appropriate by the circumstances and SA/RO policy) and providing on-going

feedback, as appropriate, to hospital leadership on the status of the survey;

• Coordinating Task 2, Entrance Conference;

• Facilitating Task 4, Preliminary Decision Making;

• Coordinating Task 5, Exit Conference; and

• Coordinating the preparation of the Form CMS-2567.

Task 1 - Off-Site Survey Preparation

General Objective

The objective of this task is to analyze information about the provider in order to identify

areas of potential concern to be investigated during the survey and to determine if those

areas, or any special features of the provider (e.g., provider-based clinics, remote locations,

satellites, specialty units, PPS-exempt units, services offered, etc.) require the addition of

any specialty surveyors to the team. Information obtained about the provider will also

allow the SA (or the RO for Federal teams) to determine survey team size and composition,

and to develop a preliminary survey plan. The type of provider information needed

includes:

• Information from the provider file (to be updated on the survey using the

Hospital/CAH Medicare Database Worksheet), such as the facility’s ownership, the

type(s) of services offered, any prospective payment system (PPS) exclusion(s),

whether the facility is a provider of swing-bed services, and the number, type and

location of any off-site locations;

• Previous Federal and state survey results for patterns, number, and nature of

deficiencies, as well as the number, frequency, and types of complaint investigations

and the findings;

• Information from CMS databases available to the SA and CMS. Note the exit date

of the most recent survey;

• Waivers and variances, if they exist. Determine if there are any applicable survey

directive(s) from the SA or the CMS Regional Office (RO); and

• Any additional information available about the facility (e.g., the hospital’s Web site,

any media reports about the hospital, etc).

Off-Site Survey Preparation Team Meeting

The team should prepare for the survey offsite so they are ready to begin the survey

immediately upon entering the facility. The team coordinator should arrange an off-site

preparation meeting with as many team members as possible, including specialty surveyors.

This meeting may be a conference call if necessary.

During the meeting, discuss at least the following:

• Information gathered by the team coordinator;

• Significant information from the CMS databases that are reviewed;

• Update and clarify information from the provider file so a surveyor can update the

Medicare database using the “Hospital/CAH Medicare Database Worksheet,”

Exhibit 286;

• Layout of the facility (if available);

• Preliminary team member assignments;

• Date, location and time team members will meet to enter the facility;

• The time for the daily team meetings; and

• Potential date and time of the exit conference.

Gather copies of resources that may be needed. These may include:

• Medicare Hospital CoP and Interpretive Guidelines (Appendix A);

• Survey protocol and modules;

• Immediate Jeopardy (Appendix Q);

• Responsibilities of Medicare Participating Hospitals in Emergency Cases

(Appendix V);

• Hospital Swing-Bed Regulations and Interpretive Guidelines (Appendix T);

• Hospital/CAH Medicare Database Worksheet, Exhibit 286;

• Exhibit 287, Authorization by Deemed Provider/Supplier Selected for

Accreditation Organization Validation Survey; and

• Worksheets for swing-bed, PPS exclusions, and restraint/seclusion death reporting.

Task 2 - Entrance Activities

General Objectives

The objectives of this task are to explain the survey process to the hospital and obtain the

information needed to conduct the survey.

General Procedures

Arrival

The entire survey team should enter the hospital together. Upon arrival, surveyors should

present their identification. The team coordinator should announce to the Administrator, or

whoever is in charge, that a survey is being conducted. If the Administrator (or person in

charge) is not onsite or available (e.g., if the survey begins outside normal daytime

Monday-Friday working hours), ask that they be notified that a survey is being conducted.

Do not delay the survey because the Administrator or other hospital staff is/are not on site

or available.

Entrance Conference

The entrance conference sets the tone for the entire survey. Be prepared and courteous, and

make requests, not demands. The entrance conference should be informative, concise, and

brief; it should not utilize a significant amount of time. Conduct the entrance conference

with hospital administrative staff that is available at the time of entrance. During the

entrance conference, the Team Coordinator should address the following:

• Explain the purpose and scope of the survey;

• Briefly explain the survey process;

• Introduce survey team members, including any additional surveyors who may join

the team at a later time, the general area that each will be responsible for, and the

various documents that they may request;

• Clarify that all hospital areas and locations, departments, and patient care settings

under the hospital provider number may be surveyed, including any contracted

patient care activities or patient services located on hospital campuses or hospital

provider based locations;

• Explain that all interviews will be conducted privately with patients, staff, and

visitors, unless requested otherwise by the interviewee;

• Discuss and determine how the facility will ensure that surveyors are able to obtain

the photocopies of material, records, and other information as they are needed;

• Obtain the names, locations, and telephone numbers of key staff to whom questions

should be addressed;

• Discuss the approximate time, location, and possible attendees of any meetings to be

held during the survey. The team coordinator should coordinate any meetings with

facility leadership; and

• Propose a preliminary date and time for the exit conference.

During the entrance conference, the Team Coordinator will arrange with the hospital

administrator, or available hospital administrative supervisory staff if he/she is unavailable

to obtain the following:

• A location (e.g., conference room) where the team may meet privately during the

survey;

• A telephone for team communications, preferably in the team meeting location;

• A list of current inpatients, providing each patient’s name, room number,

diagnosis(es), admission date, age, attending physician, and other significant

information as it applies to that patient. The team coordinator will explain to the

hospital that in order to complete the survey within the allotted time it is important

the survey team is given this information as soon as possible, and request that it be

no later than 3 hours after the request is made. SAs may develop a worksheet to give

to the facility for obtaining this information;

• A list of department heads with their locations and telephone numbers;

• A copy of the facility’s organizational chart;

• The names and addresses of all off-site locations operating under the same provider

number;

• The hospital’s infection control plan;

• A list of employees;

• The medical staff bylaws and rules and regulations;

• A list of contracted services; and

• A copy of the facility’s floor plan, indicating the location of patient care and

treatment areas;

Arrange an interview with a member of the administrative staff to complete the

Hospital/CAH Medicare Database Worksheet that will be used to update the provider’s file

in the Medicare database. The worksheet may not be given to hospital personnel for

completion.

Hospital Tours

Guided tours of the hospital are not encouraged and should be avoided. While a tour of a

small facility may take place in less than one-man hour, a tour of a large facility could

consume several man hours of allocated survey time and resources that are needed to

conduct the survey.

Initial On-Site Team Meeting

After the conclusion of the Entrance Conference, the team will meet in order to evaluate

information gathered, and modify surveyor assignments, as necessary. Do not delay the

continuation of the survey process waiting for information from the provider, but adjust

survey activities as necessary. During the on-site team meeting, team members should:

• Review the scope of hospital services;

• Identify hospital locations to be surveyed, including any off-site locations;

• Add survey protocol modules and adjust surveyor assignments, as necessary, based

on new information;

• Discuss issues such as change of ownership, sentinel events, construction activities,

and disasters, if they have been reported;

• Make an initial patient sample selection (The patient list may not be available

immediately after the entrance conference, therefore the team may delay completing

the initial patient sample selection a few hours as meets the needs of the survey

team); and

• Set the next meeting time and date.

Sample Size and Selection

To select the patient sample, review the patient list provided by the hospital and select

patients who represent a cross-section of the patient population and the services provided.

Patient logs (ER, OB, OR, restraint, etc) may be used in conjunction with the patient list to

assure the sample is reflective of the scope of services provided by the hospital.

Whenever possible and appropriate, select patients who are in the facility during the time of

survey (i.e., open records). Open records allow surveyors to conduct a patient-focused

survey and enable surveyors to validate the information obtained through record reviews

with observations and patient and staff interviews. There may be situations where closed

records are needed to supplement the open records reviewed (e.g., too few open records,

complaint investigation, etc), surveyors should use their professional judgment in these

situations and select sample that will enable them to make compliance determinations. If it

is necessary to remove a patient from the sample during the survey, (e.g., the patient refuses

to participate in an interview), replace the patient with another who fits a similar profile.

This should be done as soon as possible in the survey.

Select the number of patient records for review based on the facility’s average daily census.

The sample should be at least 10 percent of the average daily census, but not fewer than 30

inpatient records. For small general hospitals (this reduction does not apply to surgical or

other specialty hospitals) with an average daily census of 20 patients or less, the sample

should not be fewer than 20 inpatient records, provided that number of records is adequate

to determine compliance. Within the sample, select at least one patient from each nursing

unit (e.g., med/surg, ICU, OB, pediatrics, specialty units, etc). In addition to the inpatient

sample, select a sample of outpatients in order to determine compliance in outpatient

departments, services, and locations. The sample size may be expanded as needed to assess

the hospital’s compliance with the CoP.

If a complaint is being investigated during the survey, include patients who have been

identified as part of the complaint in the sample. Issues or concerns identified through

complaints may be an area of focus when selecting the patient sample.

Give each patient in the sample a unique identifier. Appropriate identifiable information

should be kept on a separate identifier list. Do not use medical record numbers, Social

Security numbers, care unit or billing record numbers to identify patients.

To conduct an initial survey of a hospital there must be enough inpatients currently in the

hospital and patient records (open and closed) for surveyors to determine whether the

hospital can demonstrate compliance with all the applicable CoP. The number of current

and discharged inpatients and outpatients in relation to the complexity of care provided to

patients and the length of stay of those patients needs to be large enough for surveyors to

evaluate the manner and degree to which the hospital satisfies all the standards within each

CoP including any CoP applying to optional services offered by the hospital. Utilize the

same sample size and selection methods as previously discussed.

Task 3 - Information Gathering/Investigation

General Objective

The objective of this task is to determine the hospital’s compliance with the Medicare CoP

through observations, interviews, and document review.

Guiding Principles

• Focus attention on actual and potential patient outcomes, as well as required

processes.

• Assess the care and services provided, including the appropriateness of the care and

services within the context of the regulations.

• Visit patient care settings, including inpatient units, outpatient clinics, anesthetizing

locations, emergency departments, imaging, rehabilitation, remote locations,

satellites, etc.

• Observe the actual provision of care and services to patients and the effects of that

care, in order to assess whether the care provided meets the needs of the individual

patient.

• Use the interpretive guidelines and other published CMS policy statements to guide

the survey.

• Use Appendix Q for guidance if Immediate Jeopardy is suspected.

General Procedures

Survey Locations

For hospitals with either no or a small number of off-campus provider-based locations,

survey all departments, services, and locations that bill for services under the hospital’s

provider number and are considered part of the hospital.

For hospitals with many provider-based locations survey:

• All hospital departments and services at the primary hospital campus and on the

campuses of other remote locations of the hospital;

• All satellite locations of the hospital;

• All inpatient care locations of the hospital;

• All out-patient surgery locations of the hospital;

• All locations where complex out-patient care is provided by the hospital; and

• Select a sample of each type of other services provided at additional provider-

based locations.

On any Medicare hospital survey, contracted patient care activities or patient services (such

as dietary services, treatment services, diagnostic services, etc.) located on hospital

campuses or hospital provider based locations should be surveyed as part of the hospital for

compliance with the conditions of participation.

During the Survey

• Observe what activities are taking place and assess the CoP that represent the scope

and complexity of the patient care services located at each location, as well as, any

other CoP that apply to those locations. Expand the survey activities as necessary.

• The SA and surveyors have discretion whether to allow, or to refuse to allow,

facility personnel to accompany the surveyors during a survey. Surveyors should

make a decision whether to allow facility personnel to accompany them based on

the circumstances at the time of the survey.

• The team should meet at least daily in order to assess the status of the survey,

progress of completion of assigned tasks, areas of concern, and to identify areas for

additional investigations. The team meetings should include an update by each

surveyor that addresses findings and areas of concern that have been identified. If

areas of concern are identified in the discussion, the team should coordinate efforts

to obtain additional information. Additional team meetings can be called at any time

during the survey to discuss crucial problems or issues.

• All significant issues or significant adverse events must be brought to the team

coordinator’s attention immediately.

• Maintain open and ongoing dialogue with the facility staff throughout the survey

process. Conferences with facility staff may be held in order to inform them of

survey findings. This affords facility staff the opportunity to present additional

information or to offer explanations concerning identified issues. Survey

information must not be discussed unless the investigation process and data

collection for the specific concerns is completed.

• Surveyors should always maintain a professional working relationship with facility

staff.

• Surveyors need to respect patient privacy and maintain patient confidentiality at all

times during the survey.

• Surveyors should maintain their role as representatives of a regulatory agency.

Although non-consultative information may be provided upon request, the surveyor

is not a consultant.

Patient Review

A comprehensive review of care and services received by each patient in the sample should

be part of the hospital survey. A comprehensive review includes observations of

care/services provided to the patient, patient and/or family interview(s), staff interview(s),

and medical record review. After obtaining the patient’s permission, observe each sample

patient receiving treatments (e.g., intravenous therapy, tube feedings, wound dressing

changes) and observe the care provided in a variety of treatment settings, as necessary, to

determine if patient needs are met.

Observations

Observations provide first-hand knowledge of hospital practice. The regulations and

interpretive guidelines offer guidance for conducting observations. Observation of the care

environment provides valuable information about how the care delivery system works and

how hospital departments work together to provide care. Surveyors are encouraged to

make observations, complete interviews, and review records and policies/procedures by

stationing themselves as physically close to patient care as possible. While completing a

chart review, for instance, it may be possible to also observe the environment and the

patients, as far as care being given, staff interactions with patients, safety hazards, and

infection control practices. When conducting observations, particular attention should be

given to the following:

• Patient care, including treatments and therapies in all patient care settings;

• Staff member activities, equipment, documentation, building structure, sounds and

smells;

• People, care, activities, processes, documentation, policies, equipment, etc., that are

present that should not be present, as well as, those that are not present that should

be present;

• Integration of all services, such that the facility is functioning as one integrated

whole;

• Whether quality assessment and performance improvement (QAPI) is a facility-

wide activity, incorporating every service and activity of the provider and whether

every facility department and activity reports to, and receives reports from, the

facility’s central organized body managing the facility-wide QAPI program; and

• Storage, security and confidentiality of medical records.

A surveyor should take complete notes of all observations and should document: the date

and time of the observation(s); location; patient identifiers, individuals present during the

observation, and the activity being observed (e.g., therapy, treatment modality, etc).

A surveyor should have observations verified by the patient, family, facility staff, other

survey team member(s), or by another mechanism. For example, when finding an out-dated

medication in the pharmacy, ask the pharmacist to verify that the drug is out-dated. In

addition, a surveyor should integrate the data from observations with data gathered through

interviews and document reviews.

Surveyors must not examine patients by themselves, although in certain circumstances, in

order to determine a patient’s health status and whether appropriate health care is being

provided, especially to ensure a patient’s welfare where he/she appears to be in immediate

jeopardy, it is permissible and necessary to examine the patient. After obtaining permission

from the patient, the surveyor should request that a staff member of the facility examine the

patient in the surveyor’s presence. The health and dignity of the patient is always of

paramount concern. A surveyor must respect the patient’s right to refuse to be examined.

Interviews

Interviews provide a method to collect information, and to verify and validate information

obtained through observations. Informal interviews should be conducted throughout the

duration of the survey. Use the information obtained from interviews to determine what

additional observations, interviews, and record reviews are necessary. When conducting

interviews, observe the following:

• Maintain detailed documentation of each interview conducted. Document the

interview date, time, and location; the full name and title of the person

interviewed; and key points made and/or topics discussed. To the extent

possible, document quotes from the interviewee.

• Interviews with facility staff should be brief. Use a few well-phrased questions

to elicit the desired information. For example, to determine if a staff member is

aware of disaster procedures and his/her role in such events, simply ask, “If you

smelled smoke, what would you do?”

• When interviewing staff, begin your interviews with staff that work most closely

with the patient.

• Conduct patient interviews regarding their knowledge of their plan of care, the

implementation of the plan, and the quality of the services received. Other

topics for patient or family interview may include patient rights, advanced

directives, and the facility’s grievance/complaint procedure.

• Interviews with patients must be conducted in privacy and with the patient’s

prior permission.

• Use open-ended questions during your interview.

• Validate all information obtained.

• Telephone interviews may be conducted if necessary, but a preference should be

made for in- person interviews.

• Integrate the data from interviews with data gathered through observations and

document reviews.

Staff interviews should gather information about the staff’s knowledge of the patient’s

needs, plan of care, and progress toward goals. Problems or concerns identified during a

patient or family interview should be addressed in the staff interview in order to validate the

patient’s perception, or to gather additional information.

Patient interviews should include questions specific to the patient’s condition, reason for

hospital admission, quality of care received, and the patients knowledge of their plan of

care. For instance, a surgical patient should be questioned about the process for preparation

for surgery, the patient’s knowledge of and consent for the procedure, pre-operative patient

teaching, post-operative patient goals and discharge plan.

Document Review

Document review focuses on a facility’s compliance with the CoP. When conducting a

document review, document the source and date of the information obtained. When making

document copies, identify the original date of the document and indicate the date and time

the copies were made. Once a document review is completed, integrate the data obtained

with data gathered through observations and interviews to decide if the hospital is in

compliance with the CoP. Documents reviewed may be both written and electronic and

include the following:

• Patient’s clinical records, to validate information gained during the interviews, as

well as for evidence of advanced directives, discharge planning instructions, and

patient teaching. This review will provide a broad picture of the patient’s care.

Plans of care and discharge plans should be initiated immediately upon admission,

and be modified as patient care needs change. The record review for that patient

who has undergone surgery would include a review of the pre-surgical assessment,

informed consent, operative report, and pre-, inter-, and post-operative anesthesia

notes. Although team members may have a specific area assigned during the

survey, the team should avoid duplication of efforts during review of medical

records and each surveyor should review the record as a whole instead of targeting

the assigned area of concern. Surveyors should use open patient records rather than

closed records, whenever possible;

• Closed medical records may be used to determine past practice, and the scope or

frequency of a deficient practice. Closed records should also be reviewed to provide

information about services that are not being provided by the hospital at the time of

the survey. For example, if there are no obstetrical patients in the facility at the

time of the survey, review closed OB records to determine care practices, or to

evaluate past activities that cannot be evaluated using open records. In the review of

closed clinical records, review all selected medical records for an integrated plan of

care, timelines of implementation of the plan of care, and the patient responses to

the interventions.

• Personnel files to determine if staff members have the appropriate educational

requirements, have had the necessary training required, and are licensed, if it is

required;

• Credential files to determine if the facility complies with CMS requirements and

State law, as well as, follows its own written policies for medical staff privileges

and credentialing;

• Maintenance records to determine if equipment is periodically examined and to

determine if it is in good working order and if environmental requirements have

been met;

• Staffing documents to determine if adequate numbers of staff are provided

according to the number and acuity of patients;

• Policy and procedure manuals. When reviewing policy and procedure manuals,

verify with the person in charge of an area that the policy and procedure manuals are

current; and

• Contracts, if applicable, to determine if patient care, governing body, QAPI, and

other CoP requirements are included.

Photocopies

Surveyors should make photocopies of all documents needed to support survey findings.

The surveyor needs access to a photocopier where he/she can make their own photocopies

of needed documents. If requested by the hospital, the surveyor should make the hospital a

copy of all items photocopied. All photocopies need to be dated and timed as to when

photocopied, and identified such as “hospital restraint policy- 2/17/04 page 3” or “Patient #

6, progress note- 2/17/04.”

Completion of Hospital/CAH Medicare Database Worksheet

Arrange an interview with a member of the administrative staff to update and clarify

information from the provider file. The Hospital/CAH Medicare Database Worksheet will

be used to collect information about the hospital’s services, locations, and staffing by

Medicare surveyors during hospital surveys. The worksheet will be completed by the

surveyors using observation, staff interviews, and document review. The worksheet will

not be given to hospital staff to complete. The worksheet is used to collect information that

will later be entered into the Medicare database. During the interview clarify any

inconsistencies from prior information or information gathered during the survey.

Task 4 - Preliminary Decision Making and Analysis of Findings

General Objectives

The general objectives of this task are to integrate findings, review and analyze all

information collected from observations, interviews, and record reviews, and to determine

whether or not the hospital meets the Conditions of Participation found at 42 CFR Part 482

and, as appropriate, the PPS exclusionary criteria at 42 CFR Part 412 Subpart B, and the

swing-bed requirements at 42 CFR 482.66. The team’s preliminary decision-making and

analysis of findings assist it in preparing the exit conference report. Based on the team’s

decisions, additional activities may need to be initiated.

General Procedures

Preparation

Prior to beginning this Task, each team member should review his/her notes, worksheets,

records, observations, interviews, and document reviews to assure that all investigations are

complete and organized for presentation to the team.

Discussion Meeting

At this meeting, the surveyors will share their findings, evaluate the evidence, and make

team decisions regarding compliance with each requirement. Proceed sequentially through

the requirements for each condition appropriate to the facility as they appear in regulation.

For any issues of noncompliance, the team needs to reach a consensus. Decisions about

deficiencies are to be team decisions, with each member having input. The team should

document their decisions, the substance of the evidence, and the numbers of patients

impacted, in order to identify the extent of facility noncompliance. The team must ensure

that their findings are supported by adequate documentation of observations, interviews and

document reviews and includes any needed evidence such as photocopies. Any additional

documentation or evidence needed to support identified non compliance should be gathered

prior to the exit conference but at a minimum, prior to exiting the hospital.

Determining the Severity of Deficiencies

The regulations at 42 CFR 488.26 state, “The decision as to whether there is compliance

with a particular requirement, condition of participation, or condition for coverage, depends

upon the manner and degree to which the provider or supplier satisfies the various standards

within each condition.” When noncompliance with a condition of participation is noted, the

determination of whether a lack of compliance is at the Standard or Condition level depends

upon the nature (how severe, how dangerous, how critical, etc.) and extent (how prevalent,

how many, how pervasive, how often, etc.) of the lack of compliance. The cited level of

the noncompliance is determined by the interrelationship between the nature and extent of

the noncompliance.

A deficiency at the Condition level may be due to noncompliance with requirements in a

single standard or several standards within the condition, or with requirements of

noncompliance with a single part (tag) representing a severe or critical health or safety

breach. Even a seemingly small breach in critical actions or at critical times can kill or

severely injure a patient, and represents a critical or severe health or safety threat.

A deficiency is at the Standard level when there is noncompliance with any single

requirement or several requirements within a particular standard that are not of such

character as to substantially limit a facility’s capacity to furnish adequate care, or which

would not jeopardize or adversely affect the health or safety of patients if the deficient

practice recurred.

When a deficient practice (noncompliance) is determined to have taken place prior to the

survey and the hospital states that it has corrected the deficient practice/issue

(noncompliance), issues for the survey team to consider would include:

• Is the corrective action superficial or inadequate, or is the corrective action adequate

and systemic?

• Has the hospital implemented the corrective intervention(s) or action(s)?

• Has the hospital taken a QAPI approach to the corrective action to ensure

monitoring, tracking and sustainability?

The survey team uses their judgment to determine if any action(s) taken by the hospital

prior to the survey is sufficient to correct the noncompliance and to prevent the deficient

practice from continuing or recurring. If the deficient practice is corrected prior to the

survey, do not cite noncompliance. However, if the noncompliance with any requirements

is noted during the survey, even when the hospital corrects the noncompliance during the

survey, cite noncompliance.

All noted noncompliance must be cited even when corrected on site during the survey.

Citing noncompliance at the appropriate level is important to the integrity of the survey

process. Citing too high a level is unfair to the hospital. Citing noncompliance at a level

below the noted degree and manner of the noncompliance does not ensure that the hospital

will develop acceptable plans of correction and implement corrective actions, and does not

depict accurately whether the care provided adversely affects the health and safety of

patients; and continued deficient practices may lead to adverse patient outcomes such as

injury or death.

Gathering Additional Information

If it is determined that the survey team needs additional information to determine facility

compliance or noncompliance, the team coordinator should decide the best way to conduct

the additional review.

Task 5 - Exit Conference

General Objective

The general objective of this task is to inform the facility staff of the team’s preliminary

findings.

Prior to the Exit Conference

• The team coordinator is responsible for organization of the presentation of the exit.

• The team determines who will present the findings.

• If the team feels it may encounter a problem during the exit, they should contact

their immediate supervisor.

Discontinuation of an Exit Conference

It is CMS’ general policy to conduct an exit conference at the conclusion of each survey.

However, there are some situations that justify refusal to continue or to conduct an exit

conference. For example:

• If the provider is represented by counsel (all participants in the exit conference

should identify themselves), surveyors may refuse to conduct the conference if the

lawyer tries to turn it into an evidentiary hearing; or

• Any time the provider creates an environment that is hostile, intimidating, or

inconsistent with the informal and preliminary nature of an exit conference,

surveyors may refuse to conduct or continue the conference. Under such

circumstances, it is suggested that the team coordinator stop the exit conference and

call the State agency for further direction.

Recording the Exit Conference

If the facility wishes to audio tape the conference, it must provide two tapes and tape

recorders, recording the meeting simultaneously. The surveyors should take one of the tapes

at the conclusion of the conference. Video taping is also permitted if it is not disruptive to

the conference, and a copy is provided at the conclusion of the conference. It is at the sole

discretion of the surveyor(s) to determine if video taping is permitted.

General Principles

The following general principles apply when conducting an exit conference:

• The facility determines which hospital staff will attend the exit conference.

• The identity of an individual patient or staff member must not be revealed in

discussing survey results. Identity includes not just the name of an individual

patient or staff member, but also includes any reference by which identity might be

deduced.

• Because of the ongoing dialogue between surveyors and facility staff during the

survey, there should be few instances in which the facility is unaware of surveyor

concerns or has not had an opportunity to present additional information prior to the

exit conference.

Exit Conference Sequence

The following discusses the sequence of events in conducting an exit conference.

Introductory Remarks:

• Thank everyone for cooperation during the survey.

• Introduce all team members, mentioning any that have concluded their portion of

the survey and have left the facility.

• Briefly mention the reason for the survey.

• Explain that the exit conference is an informal meeting to discuss preliminary

findings.

• Indicate that official findings are presented in writing on the Form CMS-2567.

Ground Rules

• Explain how the team will conduct the exit conference and any ground rules.

• Ground rules may include waiting until the surveyor finishes discussing each

deficiency before accepting comments from facility staff.

• State that the provider will have an opportunity to present new information after the

exit conference for consideration after the survey.

Presentation of Findings

• Avoid referring to data tag numbers.

• Present the findings of noncompliance, explaining why the findings are a violation.

If the provider asks for the regulatory basis, provide it.

• Refrain from making any general comments (e.g., “Overall the facility is very

good”). Stick to the facts. Do not rank findings. Treat requirements as equal as

possible.

• Do not identify unmet requirements as condition or standard level. Avoid

statements such as, “the condition was not met” or “the standard was not met.” It is

better to state “the requirement is not met.”

• If immediate jeopardy was identified, explain the significance and the need for

immediate correction. Follow instructions in Appendix Q.

• Assure that all findings are discussed at the exit conference.

Closure

• Explain that a statement of deficiencies (Form CMS-2567) will be mailed within 10

working days to the hospital.

• Explain that the Form CMS-2567 is the document disclosed to the public about the

facility’s deficiencies and what is being done to remedy them. The Form CMS-

2567 is made public no later than 90 calendar days following completion of the

survey. It documents specific deficiencies cited, the facility’s plans for correction

and timeframes, and it provides an opportunity for the facility to refute survey

findings and furnish documentation that requirements are met.

• Inform the facility that a written plan of correction must be submitted to the survey

agency within 10 calendar days following receipt of the written statement of

deficiencies.

• Explain the required characteristics of a plan of correction. The characteristics

include:

Corrective action to be taken for each individual affected by the deficient practice,

including any system changes that must be made;

• The position of the person who will monitor the corrective action and the

frequency of monitoring;

• Dates each corrective action will be completed;

• The administrator or appropriate individual must sign and date the Form

CMS-2567 before returning it to the survey agency; and

• The submitted plan of correction must meet the approval of the State agency,

or in some cases the CMS Regional Office for it to be acceptable.

• If the exit conference was audio or video taped, obtain a copy of the tape in its

entirety before leaving the facility.

All team members should leave the facility together immediately following the exit

conference. If the facility staff provides further information for review, the team

coordinator should decide the best way to conduct the further review. It is usually prudent

for at least two individuals to remain.

Task 6 – Post-Survey Activities

General Objective

The general objective of this task is to complete the survey and certification requirements,

in accordance with the regulations found at 42 CFR Part 488.

General Procedures

Each State agency and Federal Regional Office should follow directives in the State

Operations Manual. The procedures include:

• Timelines for completing each step of the process;

• Responsibilities of the team coordinator and other team members to complete the

Form CMS-2567, “Statement of Deficiencies,” following the “Principles of

Documentation”;

• Notification to the facility staff regarding survey results;

• Additional survey activities based on the survey results (e.g., revisit, forwarding

documents to the Regional Office for further action/direction);

• Completion of “Hospital Restraint/Seclusion Death Reporting Worksheet,” as

appropriate;

• Compilation of documents for the provider file;

• Signed Authorization by Deemed Provider/Supplier Selected for Accreditation

Organization Validation Survey is forwarded to RO; and

• Enter the information collected on the Hospital/CAH Medicare Database Worksheet

into the Medicare database.

Plan of Correction

Regulations at 42 CFR 488.28(a) allow certification of providers with deficiencies at the

Standard or Condition level “only if the facility has submitted an acceptable plan of

Correction [POC] for achieving compliance within a reasonable period of time acceptable

to the Secretary.” Failure to submit a POC may result in termination of the provider

agreement as authorized by 42 CFR 488.28(a) and §489.53(a)(1). After a POC is

submitted, the surveying entity makes the determination of the appropriateness of the POC.

Psychiatric Hospital Survey Module

Background

State survey agencies are given the responsibility for conducting surveys of psychiatric

hospitals to determine compliance with the two special conditions of participation.

However, most are not staffed with the personnel with the psychiatric expertise necessary to

conduct the surveys. In light of this, CMS has contracted out this function for many years,

and a panel of contracted psychiatric consultants has conducted the majority of surveys of

psychiatric hospitals.

General Procedures

When conducting a validation survey or other full survey of a psychiatric hospital using the

hospital A-tags located in Appendix A of the SOM, the SA is also expected to conduct a

review of the two special conditions of participation for psychiatric hospitals if:

• The State survey agency has the expertise (i.e., at a minimum a Masters prepared

psychiatric nurse or an RN with inpatient psychiatric nursing experience) to serve on

the team. The surveyors should conduct the survey of the two special conditions as

outlined in Appendix AA of the State Operations Manual.

It is strongly recommended that when the State survey agency does not have the clinical

expertise to conduct surveys of psychiatric hospitals, the SA should request, through its

regional office, the assistance of the contracted psychiatric surveyors.

Regulatory Authority and Requirements for Psychiatric Hospitals

The following regulations describe the special requirements for psychiatric hospitals:

• 42 CFR 482.60 -- Special provisions applying to psychiatric hospitals;

• 42 CFR 482.61 -- Special medical record requirements for psychiatric hospitals; and

• 42 CFR 482.62 -- Special staff requirements for psychiatric hospitals.

The focus of the survey is on the “outcome” experienced by the patient and how the

provider implements the plan of care. The survey process includes seven (7) tasks. When

these tasks are viewed in total, they give a clear indication of how the provider is meeting

or not meeting the requirements. Appendix AA of the State Operations Manual (SOM)

gives detailed instructions on how to perform these tasks. The seven tasks are:

• Representative sample of patients -- selection methodology;

• Record review of individuals in the sample;

• Other record review;

• Direct patient observation;

• Interviews;

• Visit to each area of the hospital serving certified patients; and

• Team assessment of compliance.

Survey Preparation When Surveying the Two Special Conditions

When the SA is preparing to perform a survey of the special conditions while conducting a

full survey (A-tags) of a psychiatric hospital, include in the preparation for the survey a

review of Appendix A of the SOM, “Interpretive Guidelines and Survey Procedures for

Hospitals,” and a review of Appendix AA, “Interpretive Guidelines and Survey Procedures

for Psychiatric Hospitals.” Appendix AA includes the following exhibits:

• Exhibit 1, “Medicare/Medicaid Psychiatric Hospital Survey Data,” Form CMS-724

(this form must be completed by the hospital and survey team.)

• Exhibit 2, “Surveyor Worksheet for Psychiatric Hospital Review: Two Special

Conditions,” Form CMS-725 (*optional)

• Exhibit 3, “CMS Death Record Review Data Sheet,” Form CMS-726 (*optional)

• Exhibit 4, “CMS Nursing Complement Data,” Form CMS-727 (*optional)

• Exhibit 5, “CMS Total Nursing Staff Data,” Form CMS-728 (*optional)

• Exhibit 6, “Data Collection Medical Staff Coverage,” Form CMS-729 (*optional)

*Although these forms are optional, they are useful for data collection purposes and will

assist in determining the hospital’s compliance status.

Identify all remote and satellite locations of the psychiatric hospital.

Survey Methods

Follow the interpretive guidelines and survey protocol in Appendix AA to determine

compliance with the two special conditions. As judged appropriate by the survey team,

patients selected for the survey of the two special conditions may be used to meet the

patient selection requirements in the hospital survey protocol. Surveyors should select

patients using the sample selection methodology in Appendix AA of the psychiatric

hospital survey protocol and, using the hospital survey protocol patient selection methods,

should select any remaining or additional patients needed to determine the hospital’s

compliance with the hospital CoP.

Identify any psychiatric hospital satellite(s), remote locations, or other provider based

location(s). Record the location, name, address, and telephone number for every satellite,

remote location, or provider based location on the Hospital/CAH Medicare Database

Worksheet for updating the Medicare database.

Post-Survey Activities

Follow the directions and procedures in the SOM for post-survey activities. The findings

for deficiencies noted for the A-tags and B-tags must be documented on separate Form

CMS-2567.

Psychiatric Unit Survey Module

When conducting a full survey of an accredited or non-accredited hospital that has a PPS

excluded psychiatric unit, conduct a survey of the psychiatric unit using the survey methods

in this module to assess the hospital’s compliance with the excluded psychiatric unit

requirements.

Excluded unit surveys utilizing these methods will count as annual validation compliance

surveys of the hospital’s self-attestation of compliance with the excluded psychiatric unit

requirements.

Background

The PPS excluded psychiatric unit is part of the hospital and is included as part of the

overall hospital survey. The term “exclusion” is a reimbursement term. Patient care in a

PPS excluded psychiatric unit is reimbursed at the PPS psychiatric unit excluded rate rather

than the hospital PPS rate. In order for a hospital to receive the excluded rate for

psychiatric care provided in its excluded unit, the unit must comply with the excluded

psychiatric unit requirements found at 42 CFR 412.27.

A PPS excluded psychiatric unit is regulated by both the hospital CoP at 42 CFR 482 (also

found in Appendix A of the SOM) and the PPS excluded psychiatric unit requirements at 42

CFR 412.27. The actual psychiatric unit requirements are based on the Special Conditions

of Participation for Psychiatric Hospitals found in §§482.60, 482.61, and 482.62.

Requirements for PPS Excluded Psychiatric Units

• 42 CFR 482 - Conditions of Participation for hospitals;

• 42 CFR 412.25 - Excluded hospital units: Common Requirements; and

• 42 CFR 412.27 - Excluded psychiatric units: Additional Requirements

Activities Conducted Prior to Psychiatric Unit Survey

• Contact the RO to determine if the hospital has approval for a PPS excluded

psychiatric unit.

• Contact the RO to determine the unit’s cost-reporting period.

• If possible, establish the location or locations of the psychiatric unit. Determine if

the unit has a satellite or satellites in other locations. Determination or verification

of this information may have to wait until the survey team is onsite.

• Do not conduct the survey of the PPS excluded psychiatric unit requirements within

90 days of the end of the hospital’s cost reporting period.

• Review the “Psychiatric Unit Criteria Worksheet,” Form CMS-437.

Survey Tool

The “Psychiatric Unit Criteria Worksheet,” Form CMS-437.

Survey Procedures for Determining Compliance with the PPS Excluded Psychiatric

Unit Requirements

• The surveyor of the psychiatric unit requirements should be an RN.

• Select 10 percent of the unit’s average daily census or a minimum of two patients

for the patient sample.

• The selected patients should be included in the patient sample used for the full

hospital survey.

• Hospital survey activities should be conducted concurrently with the survey of the

PPS excluded psychiatric unit requirements.

• Using the “Psychiatric Unit Criteria Worksheet,” Form CMS-437, verify whether

the requirements have been met by checking the appropriate boxes marked “YES”

and “NO.” Under the column “Explanatory Statement,” document specifics of the

findings. Additional findings can be documented in a narrative note that should be

attached to the worksheet.

• Select additional patients (open or closed records) as needed to determine

compliance with the excluded psychiatric unit requirements.

• If there are patients on the unit who were admitted the day before or on the day of

the survey, verify that all applicable requirements have been completed or are

already in place. These patients are in addition to the number of patients needed to

establish the minimum patient sample size.

• If there are no patients on the unit at the time the survey is conducted, review closed

patient records of unit patients treated within 6 months of the date of the survey.

• Identify if the psychiatric unit has a satellite or satellites. Record the location, name,

address, and telephone number for every satellite on the Hospital/CAH Medicare

Database Worksheet for updating the Medicare database.

Exit Conference

• Inform the hospital of findings of noncompliance with the excluded psychiatric unit

requirements.

• Inform the hospital that the SA will forward the completed CMS Form-437 to the

hospital at the same time as the completed CMS Form-2567.

Post-Survey Activities

• Do not include the survey findings of the excluded psychiatric unit requirements on

the Form CMS-2567 that is used to document the hospital survey findings.

• If there are requirements that have not been met, notify the RO. Document survey

findings of PPS psychiatric unit requirements on the Form CMS-437. Submit the

completed Form CMS-437 to the RO within the same time frame as the completion

of the Form CMS-2567 and at least 60 days prior to the end of the hospital’s cost

reporting period.

• Follow the procedures in the SOM for post-survey activities.

Rehabilitation Hospital Survey Module

When conducting a full survey of an accredited or non-accredited rehabilitation hospital,

conduct a survey of the hospital’s compliance with rehabilitation hospital excluded

requirements using the survey methods in this module.

Surveys of the PPS excluded rehabilitation hospital requirements utilizing these methods

will count as annual validation compliance surveys of the hospital’s self-attestation of

compliance with the excluded requirements.

Background

The term “exclusion” is a reimbursement term. Patient care in a PPS excluded

rehabilitation hospital is reimbursed at the PPS rehabilitation hospital excluded rate rather

than at the hospital PPS rate. In order for a hospital to receive the excluded rate for

rehabilitation care provided, the hospital must comply with the excluded requirements

found at 42 CFR 412.

A PPS excluded rehabilitation hospital is regulated by both the hospital CoP at 42 CFR 482

(also found in Appendix A of the SOM) and the PPS excluded rehabilitation hospital

requirements at 42 CFR 412.

Regulatory Authority and Requirements for PPS Excluded Rehabilitation Hospitals

• 42 CFR 482 - Conditions of Participation for Hospitals;

• 42 CFR 412.22 - Excluded hospitals and hospital units: General rules; and

• 42 CFR 412.23 - Excluded hospitals: Classifications

Activities Conducted Prior to a Rehabilitation Hospital Survey

• Contact the RO to determine if the hospital has approval for a PPS excluded

rehabilitation hospital.

• Contact the RO to determine the hospital’s cost reporting period.

• Do not conduct the survey of the PPS excluded rehabilitation hospital requirements

within 90 days of the end of the hospital’s cost reporting period.

• Identify any satellite locations of the hospital.

• Verify with the RO that the hospital is in compliance with the inpatient population

percent rule, and that each satellite, if any, is independently in compliance with the

inpatient population percent rule.

• Review the “Rehabilitation Hospital Criteria Worksheet,” Form CMS-437B.

Survey Tool

“Rehabilitation Hospital Criteria Worksheet,” Form CMS-437B.

Survey Procedures for Determining Compliance with the PPS Excluded

Rehabilitation Hospital Requirements

• Survey activities to determine hospital compliance with the PPS excluded

rehabilitation hospital requirements should be conducted concurrently with the full

survey of the hospital’s compliance with the hospital CoP.

• Using the “Rehabilitation Hospital Criteria Worksheet,” Form CMS-437B, verify

whether the requirements have been met by checking the appropriate box marked

“YES” or “NO.” Under the column “Explanatory Statement,” document specifics

about the findings. Additional findings can be documented in a narrative note that

should be attached to the worksheet.

• Select a minimum of two current inpatients for the patient sample.

• Select additional patients (open or closed records) as needed to determine

compliance with the excluded rehabilitation hospital requirements.

• The selected patients should be included in the patient sample used for the full

hospital survey.

• Identify if the rehabilitation hospital has remote locations, satellites, or other

provider based locations. Record the location, name, address and telephone number

for every remote location, satellite, or provider based location on the Hospital/CAH

Medicare Database Worksheet for updating the Medicare database.

Exit Conference

• Inform the hospital of findings of noncompliance with the excluded rehabilitation

hospital requirements.

• Inform the hospital that the SA will forward the completed Form CMS-437B to the

hospital at the same time as the completed Form CMS-2567.

Post Survey Activities

• Do not include the survey findings for the PPS excluded rehabilitation hospital

requirements on the Form CMS-2567.

• If there are PPS excluded hospital requirements that have not been met, notify the

RO. Document survey findings of the PPS excluded rehabilitation hospital

requirements on the CMS 437B. Submit the completed Form CMS-437B to the RO

within the same time frame as the completion of the Form CMS-2567 and at least 60

days prior to the end of the hospital’s cost reporting period.

• Follow the requirements in the SOM for post-survey activities.

Inpatient Rehabilitation Unit Survey Module

When conducting a full survey of an accredited or non-accredited hospital that has a PPS

excluded rehabilitation unit, conduct a survey of the rehabilitation unit using the survey

methods in this module to assess the hospital’s compliance with the excluded rehabilitation

unit requirements.

Surveys of the PPS excluded rehabilitation unit requirements utilizing these methods will

count as annual validation compliance surveys of the hospital’s self-attestation of

compliance with the excluded requirements.

Background

The PPS excluded rehabilitation unit is part of the hospital and is included as part of the

overall hospital survey. The term “exclusion” is a reimbursement term. Patient care in a

PPS excluded rehabilitation unit is reimbursed at the PPS excluded rehabilitation unit rate

rather than the hospital PPS rate. In order for a hospital to receive the excluded rate for

rehabilitation care provided in its excluded unit, the unit must comply with the excluded

rehabilitation unit requirements found at 42 CFR 412.

A PPS excluded rehabilitation unit is regulated by both the hospital CoP at 42 CFR 482

(also found in Appendix A of the SOM) and the PPS excluded rehabilitation unit

requirements at 42 CFR 412.

Requirements for PPS Excluded Rehabilitation Units

• 42 CFR 482 - Conditions of Participation for hospitals;

• 42 CFR 412.25 - Excluded hospital units: Common Requirements;

• 42 CFR 412.29 - Excluded rehabilitation units: Additional Requirements; and

• State Operations Manual, Chapter 3, §3100.

Activities Conducted Prior to Rehabilitation Unit Survey

• Contact the RO to determine if the hospital has approval for a PPS excluded

rehabilitation unit.

• Contact the RO to determine the unit’s cost-reporting period.

• Do not conduct the survey of the PPS excluded rehabilitation unit requirements

within 90 days of the end of the hospital’s cost reporting period.

• Verify with the RO that the hospital is in compliance with the inpatient population

percent rule for the unit and that each rehabilitation unit satellite, if any, is

independently in compliance with the inpatient population percent rule.

• If possible, establish the location or locations of the rehabilitation unit. Determine if

the unit has a satellite or satellites in other locations. Determination or verification

of this information may have to wait until the survey team is onsite.

• Review the “Rehabilitation Unit Criteria Worksheet,” Form CMS-437A.

Survey Tool

The “Rehabilitation Unit Criteria Worksheet,” Form CMS-437A.

Survey Procedures for Determining Compliance with the PPS Excluded

Rehabilitation Unit Requirements

• Survey activities to determine hospital compliance with the PPS excluded

rehabilitation unit requirements should be conducted concurrently with the full

survey of the hospital’s compliance with the hospital CoP.

• Using the “Rehabilitation Hospital Criteria Worksheet,” Form CMS-437A, verify

whether the requirements have been met by checking the appropriate box marked

“YES” or “NO.” Under the column “Explanatory Statement,” document specifics

about the findings. Additional findings can be documented in a narrative note that

should be attached to the worksheet.

• Select 10 percent of the unit’s average daily census or a minimum of two current

patients for the patient sample.

• The selected patients should be included in the patient sample used for the full

hospital survey.

• Select additional patients (open or closed records) as needed to determine

compliance with the excluded rehabilitation unit requirements.

• If there are no patients on the unit at the time the survey is conducted, review closed

patient records of unit patients treated within six months of the survey.

• Identify if the rehabilitation unit has a satellite or satellites. Record the location,

name, address and telephone number for every satellite on the Hospital/CAH

Medicare Database Worksheet for updating the Medicare database.

Exit Conference

• Inform the hospital of findings of noncompliance with the excluded rehabilitation

unit requirements.

• Inform the hospital that the SA will forward the completed Form CMS-437A to the

hospital at the same time as the completed Form CMS-2567.

Post Survey Activities

• Do not include the survey findings for the PPS excluded rehabilitation unit

requirements on the Form CMS-2567.

• If there are PPS excluded unit requirements that have not been met, notify the RO.

Document survey finding of the PPS rehabilitation unit requirements on the

CMS-437A. Submit the completed Form CMS-437A to the RO within the same

time frame as the completion of the Form CMS-2567 and at least 60 days prior to

the end of the hospital’s cost reporting period.

• Follow the requirements in the SOM for post-survey activities.

Hospital Swing-Bed Survey Module

When conducting a full survey of an accredited or unaccredited hospital that has swing-bed

approval, conduct a survey of the hospital swing-bed requirements found at 42 CFR 482.66.

These requirements, as well as interpretive guidelines, are found in Appendix T of the

SOM. An optional survey worksheet, also found in Appendix T, may be used.

Background

Swing-bed patients are hospital patients who are situated in the hospital but for whom the

hospital is receiving reimbursement for skilled nursing services, as opposed to acute-care

reimbursement. The reference to swing-bed is a patient care and reimbursement status and

has no relationship to geographic location in the facility. The patient may be in acute-care

status one day and change to swing-bed status the next day. 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 or critical access hospital (CAH) 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.

Regulatory Authority and Requirements for Hospital Providers of Extended Care

Services (“Swing-beds”)

Hospital swing-bed care is regulated by both the hospital requirements at 42 CFR Part 482

(reprinted at Appendix A of the SOM) and the swing-bed requirements at 42 CFR 482.66

(also in Appendix T, along with an optional surveyor worksheet). The actual swing-bed

survey requirements are referenced in the Medicare Nursing Home requirements at 42 CFR

Part 483.

Section 1883 of the Act authorizes payment under Medicare for post-hospital SNF services

provided by any hospital that meets certain requirements. By regulation, the Secretary has

specified these requirements at 42 CFR 482.66:

• The hospital has a Medicare provider agreement;

• The facility has fewer than 100 hospital beds, excluding beds for newborns and beds

in intensive care type inpatient units;

• 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;

• The hospital does not have in effect a 24-hour nursing waiver granted under 42 CFR

§488.54(c);

• The hospital has not had a swing-bed approval terminated within the two years

previous to application; and

• The hospital meets the swing-bed CoP on Resident Rights; Admission, Transfer,

and Discharge Rights; Resident Behavior and Facility Practices; Patient Activities;

Social Services; Discharge Planning; Specialized Rehabilitative Services; and

Dental Services.

Activities Conducted Prior to Swing-Bed Survey

Prior to conducting the swing-bed survey, verify the following:

• The hospital continues to be located in a rural census tract;

• The hospital does not have a 24-hour nursing waiver in place; and

• The hospital’s swing-bed approval is in effect and has not been terminated within

the two previous years.

Survey Procedures

In conducting the survey, verify that the hospital has fewer than 100 hospital beds,

excluding beds for newborns and beds in intensive care units. A hospital licensed for more

than 100 beds may be eligible for swing-bed approval if it utilizes and staffs for fewer than

100 beds. Count the staffed beds in each nursing unit. Do not count beds in recovery

rooms, intensive care units, operating rooms, newborn nurseries or stretchers in emergency

departments.

Assess the hospital’s compliance with the swing-bed requirements at 42 CFR 482.66,

found in Appendix T of the SOM, and the hospital survey methods contained in the hospital

survey protocol. Swing-bed requirements apply to any patient discharged from the hospital

and admitted to a swing-bed for skilled nursing services. The requirements for acute-care

hospitals also apply.

If swing-bed patients are present during the on-site inspection, conduct an open record

review and an environmental assessment. Include patient interviews and observations of

care and services. However, if no swing-bed patients are present during the on-site

inspection, review two closed records for compliance with swing-bed requirements. In all

cases, review policies, procedures, and contracted services to assure that the hospital has the

capability to provide the services needed.

It is important for surveyors to maintain on-going documentation of their findings during

the course of the survey for later reference. Surveyors may use the optional swing-bed

worksheet as a note-taking tool to document and record their findings on the survey.

Exit Conference

Any findings of noncompliance may be discussed during the time of the hospital exit

conference.

Post-Survey Activities

The findings for swing-bed deficiencies must be documented on a separate Form CMS-

2567, even though the swing-bed survey is being conducted simultaneously with the

hospital survey.

Regulations and Interpretive Guidelines

(Rev. 149, Issued: 10-09-15, Effective: 10-09-15, Implementation: 10-09-15)

NOTE: in the regulations or guidance which follow, in every instance where the

following terms appear:

• “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).

Furthermore, except where CMS regulations explicitly require an interpretation in

accordance with State law, wherever the text of a regulation or associated guidance

uses the above terms 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 above.

A hospital is expected to recognize all lawful marriages and spouses for

purposes of compliance with the Conditions of Participation, regardless of

any laws to the contrary of the state or locality or other jurisdiction where

the hospital is located or where the spouse lives.

A-0001

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.2 Provision of Emergency Services by Nonparticipating Hospitals

(a) The services of an institution that does not have an agreement to participate in the

Medicare program may, nevertheless, be reimbursed under the program if--

(1) The services are emergency services; and

(2) The institution meets the requirements of section 1861(e)(1) through (5) and (7)

of the Act. Rules applicable to emergency services furnished by non-

participating hospitals are set forth in subpart G of part 424 of this chapter.

(b) Section 440.170(e) of this chapter defines emergency hospital services for purposes

of Medicaid reimbursement.

Interpretive Guidelines §482.2

The statutory requirements that a hospital must meet are:

• The hospital is primarily engaged in providing, by or under the supervision of

MD/DOs, to inpatients, diagnostic services and therapeutic services for medical

diagnosis, treatment, and care of injured, disabled or sick persons, or rehabilitation

services for the injured, disabled, or sick persons;

• The hospital maintains clinical records on all patients;

• The hospital has medical staff bylaws;

• The hospital has a requirement that every Medicare patient must be under the care

of an MD/DO;

• The hospital provides 24-hour nursing services rendered or supervised by a

registered professional nurse and has a licensed, practical, or registered professional

nurse on duty at all times; and

• The hospital is licensed or is approved as meeting the standards for licensing, as a

hospital as defined by the State.

A-0008

(Rev.172, Issued: 11-17-17, Effective: 11-17-17, Implementation: 11-17-17)

§482.1 Basis and scope.

(a) Statutory basis. (1) Section 1861(e) of the [Social Security] Act provides that—

(i) Hospitals participating in Medicare must meet certain specified requirements; and

(ii) The Secretary may impose additional requirements if they are found necessary in

the interest of the health and safety of the individuals who are furnished services in

hospitals.

. . .

(b) Scope. Except as provided in subpart A of part 488 of this chapter, the provisions

of this part serve as the basis of survey activities for the purpose of determining whether a

hospital qualifies for a provider agreement under Medicare and Medicaid.

Interpretive Guidelines §482.1(a)(1)

Hospital Definition and Regulatory Enforcement Authorities

In order to qualify for a provider agreement as a hospital (other than a psychiatric hospital

as defined at section 1861(f) of the Act) under Medicare and Medicaid, an entity must meet

and continue to meet all of the statutory provisions of §1861(e) of the Act, including the

Condition of Participation (CoP) requirements. See also 42 CFR 488.3(a)(1) and 42 CFR

489.12. This means the entity must:

• Be primarily engaged in providing, by or under the supervision of physicians, to

inpatients (A) diagnostic services and therapeutic services for medical diagnosis,

treatment, and care of injured, disabled, or sick persons, or (B) rehabilitation services

for the rehabilitation of injured, disabled, or sick persons;

• Maintain clinical records on all patients[addressed in 42 CFR 482.24, Medical

Records];

• Have medical staff bylaws [42 CFR 482.12, Governing Body, and 42 CFR 482.22,

Medical Staff];

• Have a requirement that every patient with respect to whom payment may be made

under Title XVIII must be under the care of a physician except that a patient receiving

qualified psychologist services (as defined in section 1861(ii) of the Act) may be under

the care of a clinical psychologist with respect to such services to the extent permitted

under State law [42 CFR 482.12, Governing Body];

• Provide 24-hour nursing service rendered or supervised by a registered professional

nurse, and has a licensed practical nurse or registered professional nurse on duty at all

times…[42 CFR 482.23, Nursing Services];

• Have in effect a hospital utilization review plan which meets the requirements of section

1861(k) of the Act [42 CFR 482.30, Utilization Review];

• Have in place a discharge planning process that meets the requirements of section

1861(ee) of the Act [42 CFR 482.43, Discharge Planning];

• If located in a state in which state or applicable local law provides for the licensing of

hospitals, be licensed under such law or be approved by the agency of the State or

locality responsible for licensing hospitals as meeting the standards established for such

licensing [42 CFR 482.11, Compliance with Federal, State, and Local Laws];

• Have in effect an overall plan and budget that meets the requirements of section 1861(z)

of the Act [42 CFR 482.12, Governing Body]; and

• Meet any other requirements as the Secretary finds necessary in the interest of the

health and safety of individuals who are furnished services in the institution [42 CFR

Parts 482 and 489, among others].

Primarily Engaged

Generally, a hospital is primarily engaged in providing inpatient services under section

1861(e)(1) of the Act when it is directly providing such services to inpatients. Having the

capacity or potential capacity to provide inpatient care is not the equivalent of actually

providing such care. Inpatient hospital services are defined under section 1861(b) of the

Act and in the regulations at 42 CFR Part 409, Subpart B. CMS guidance describes an

inpatient as

“a person who has been admitted to a hospital for bed occupancy for purposes of receiving

inpatient hospital services …. Generally, a patient is considered an inpatient if formally

admitted as an inpatient with the expectation that he or she will require hospital care

that is expected to span at least two midnights and occupy a bed even though it later

develops that the patient can be discharged or transferred to another hospital and not

actually use a hospital bed overnight.” (Medicare Benefit Policy Manual, Chapter 1, §10,

(https://www.cms.gov/Regulations-and-

Guidance/Guidance/Manuals/Downloads/bp102c01.pdf)

The “expectation of a two midnight stay” for an inpatient is that the intent of the physician

was that the patient be admitted to the hospital for an inpatient stay as opposed to that of

observation status which is an outpatient service.

Therefore, an average length of stay (ALOS) of two midnights would be one of the

benchmarks considered for certification as a hospital.

• In making a determination of whether or not a facility is primarily engaged in

providing inpatient services and care to inpatients, CMS considers multiple

factors and will make a final determination based on an evaluation of the facility

in totality. Such factors include, but are not limited to, average daily census

(ADC), average length of stay (ALOS), the number of off-campus outpatient

locations, the number of provider based emergency departments, the number of

inpatient beds related to the size of the facility and scope of services offered,

volume of outpaient surgical procedures compared to inpatient surgical

procedures, staffing patterns, patterns of ADC by day of the week, etc.

Hospitals are not required to have a specific inpatient to outpatient ratio in order

to meet the definition of primarily engaged.

In order for surveyors to determine whether or not a hospital is in compliance with the

statutory and regulatory requirements of Medicare participation, including the definition of

a hospital, they must observe the provision of care. Medicare requirements at 42 CFR

488.26(c)(2) state that “The survey process uses resident and patient outcomes as the

primary means to establish the compliance process of facilities and agencies. Specifically,

surveyors will directly observe the actual provision of care and services to residents and/or

patients, and the effects of that care, to assess whether the care provided meets the needs of

individual residents and/or patients.”

Because §488.26(c)(2) and section 1861(e) of the Act refer to patients (plural) hospitals

must have at least two inpatients at the time of the survey in order for surveyors to conduct

the survey. However, just because a facility has two inpatients at the time of a survey does

not necessarily mean that the facility is primarily engaged in inpatient care and satisfies all

of the statutory requirements to be considered a hospital for Medicare purposes. Having

two patients at the time of a survey is merely a starting point in the overall survey and

certification process.

If a hospital does not have at least two inpatients at the time of a survey, a survey will not

be conducted at that time and an initial review of the facility’s admission data will be

performed by surveyors while onsite to determine if the hospital has had an ADC of at least

two and an ALOS of at least two midnights over the last 12 months. Average daily census

is calculated by adding the midnight daily census for each day of the 12 month period and

then dividing the total number by the number of days in the year. For facilities that have

multiple campuses operating under the same CMS Certification Number (CCN), the ADC

is not calculated individually at each campus. All locations make up the entire facility and

the ADC will be based on the total inpatient census from all campuses. This also includes

PPS excluded psychiatric and rehabilitation units that are part of the facility.

In order to be considered primarily engaged in providing inpatient services, prospective

hospital providers and currently participating hospitals should also be able to maintain an

ALOS of two midnights or greater. The ALOS is calculated by dividing the total number of

inpatient hospital days (day of admission to day of discharge, including day of death) by the

total number of discharges in the hospital over 12 months. For facilities that have not been

operating for 12 months at the time of the survey, an ADC calculated using 12 months as

the denominator may falsely result in an ADC of less than two. Therefore, facilities that

have been operating less than 12 months at the time of the survey, should calculate its ADC

based on the number of months the facility has been operational but no less than three

months. This does not mean that a facility must be operational for at least three months

before a survey can be completed. It merely means that the ADC cannot be calculated

using a denominator of less than three months.

• If the ADC and ALOS is two or more, the State Survey Agency (SA) or Accrediting

Organization (AO) makes the determination that a second survey will be attempted

at a later date.

• If the facility does not have a minimum ADC of two inpatients and an ALOS of two

over the last 12 months (or less than 12 months for facilities that have not been

operational for at least 12 months), the facility is most likely not primarily engaged

in providing care to inpatients and the SA or AO may not conduct the survey. The

SA or AO must immediately contact the RO to inform them that a survey could not

be completed and the CMS Regional Office will review additional information

provided by the SA or AO to determine whether a second survey should be

attempted.

• When the ADC and ALOS are NOT a minimum of two, the SA or AO do not make

the final determination whether a second survey will be attempted. Instead, the SA

or AO must obtain further information from the facility (other factors described

below), review the information and make a recommendation to the RO regarding

whether a second survey should be attempted. The SA or AO must provide its

recommendation in writing to the RO along with the supporting information used to

make the recommendation. The RO must review the recommendation and

information and make a determination on whether a second survey will be

conducted and communicate its decision to the SA or AO within seven business

days of receipt of the recommendation. AO communication to the RO must be via

the current established process used for all other written communication to the RO.

• If during a second survey attempt, the facility does not have two inpatients, the

survey will not be conducted and the SA or AO must cite condition level non-

compliance with §482.1. In addition, the SA or AO must immediately notify the RO

of the situation. The RO will then proceed with either denial of certification (for

initial applicants) in the Medicare program or termination of the provider agreement

(for currently participating hospitals). For currently participating hospitals, the RO

will base any termination action on the totality of the situation including

consideration of any access to care issues.

Other factors that the CMS Regional Office should consider in determining whether to (1)

conduct a second survey or (2) recommend denial of an initial applicant or termination of a

current provider agreement, include but are not limited to:

• The number of provider-based off-campus emergency departments (EDs). An

unusually large number of off-campus EDs may suggest that a facility is not

primarily engaged in inpatient care and is instead primarily engaged in providing

outpatient emergency services.

• The number of inpatient beds in relation to the size of the facility and services

offered.

• The volume of outpatient surgical procedures compared to inpatient surgical

procedures.

• If the facility considers itself to be a “surgical” hospital, are procedures mostly

outpatient?

• Does the information indicate that surgeries are routinely scheduled early in

the week and does it appear this admission pattern results in all or most

patients being discharged prior to the weekend (for example does the facility

routinely operate in a manner that its designated “inpatient beds” are not in

use on weekends)?

• Patterns and trends in the ADC by the day of the week. For example, does the ADC

consistently drop to zero on Saturdays and Sundays? Therefore suggesting that the

facility is not consistently and primarily engaged in providing care to inpatients.

• Staffing patterns. A review of staffing schedules should demonstrate that nurses,

pharmacists, physicians, etc. are scheduled to work to support 24/7 inpatient care

versus staffing patterns for the support of outpatient operations.

• How does the facility advertise itself to the community? Is it advertised as a

“specialty” hospital or “emergency” hospital? Does the name of the facility include

terms such as “clinic” or “center” as opposed to “hospital”?

The CMS RO should consider all of the above factors (and other factors as necessary) to

make a determination as to whether or not a facility is truly operating as a hospital for

Medicare purposes. A determination of non-compliance with § 482.1 will not be based on a

single factor, such as failing to have two inpatients at the time of a survey.

It is important to note that CMS has the final authority to make the determination of

whether or not a facility has met the statutory definition of a hospital after considering the

facility’s entire situation, the recommendations of the SA or AO surveyors as well as the

evidence submitted by the SAs and AOs. As stated previously, a facility that meets State

requirements for obtaining State status as a hospital is not automatically considered a

hospital for federal survey and certification purposes without further evaluation and

consideration of all relevant CMS requirements. In addition, approval by the Medicare

administrative contractor of an enrollment application does not convey hospital status for

CMS purposes. Hospital status is only conveyed and approved by the CMS RO after a

survey has been completed and the results clearly demonstrate that the facility has met all

the federal requirements, including the statutory definition.

Survey Procedures §482.1(a)(1)

• Verify there are at least two inpatients currently in the hospital at the time of survey

• If yes, proceed with evaluating the whether the hospital is primarily engaged in

providing the requisite services of a hospital, as well as in the Conditions of

Participation.

• If there are currently no inpatients in the hospital, no survey is to be conducted and

surveyors should ask to see the following, in order to make the proper determination

of the hospital’s status and to make the proper recommendations to the RO:

o ADC over the last 12 months (or less for facilities operational for less than

12 months)

 Look for patterns and trends in the ADC by the day of the week.

o ALOS over the last 12 months (or less for facilities operational for less than

12 months)

o The number of provider-based off-campus emergency departments.

o The volume of outpatient surgical procedures compared to inpatient surgical

procedures

o Staffing schedules by day of week and shift over the last 12 months (or less

for facilities operational for less than 12 months)

o Verify the facility is providing the appropriate types and adequate numbers

of staff to support 24/7 inpatient services (i.e. nursing, pharmacy, physicians,

etc.)

o Review the number of inpatient beds in relation to the size of the facility and

services offered.

o Determine if the number of inpatient beds could support emergency or

unplanned admissions from the volumes of other services offered by the

facility, such as ED patients or outpatient surgery patients?

• If the initial review of the above information indicates that the facility is most likely

not providing care to inpatients, then a second survey will not be conducted.

However, if the review of the information indicates the facility has had an ADC and

ALOS of two over the last 12 months (or less for facilities operational for less than

12 months) and there are no other concerns regarding facility’s eligibility to be

surveyed as a hospital, then a second survey will be scheduled for a future

unannounced date after consulting with the RO.

• Whenever the SA or AO is unable to complete a survey because the hospital did not

have a sufficient number of inpatients that is a representative sample of the different

types of services and patient populations that are treated at that hospital, it must

immediately report this information to the RO.

• Determine through interview, observation, and record review that the hospital meets

the statutory requirements as defined by 1861(e), including the CoPs Verify the

facility does the following:

• Maintains clinical records on all patients;

• Has medical staff bylaws;

• Has a requirement that every patient with respect to whom payment may be

made under this title must be under the care of a physician except that a patient

receiving qualified psychologist services (as defined in section 1861(ii) of the

Act) may be under the care of a clinical psychologist with respect to such

services to the extent permitted under State law;

• Provides 24-hour nursing service rendered or supervised by a registered

professional nurse, and has a licensed practical nurse or registered professional

nurse on duty at all times…;

• Has in effect a hospital utilization review plan which meets the requirements of

section 1861(k) of the Act;

• Has in place a discharge planning process that meets the requirements of section

1861(ee) of the Act;

• If located in a state in which state or applicable local law provides for the

licensing of hospitals, be licensed under such law or be approved by the agency

of the State or locality responsible for licensing hospitals, as meeting the

standards established for such licensing;

• Has in effect an overall plan and budget that meets the requirements of section

1861(z) of the Act.

A-0020

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.11 Condition of Participation: Compliance with Federal, State and

Local Laws

Interpretive Guidelines §482.11

The hospital must ensure that all applicable Federal, State and local law requirements are

met.

A-0021

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.11(a) The hospital must be in compliance with applicable Federal

laws related to the health and safety of patients.

Survey Procedures §482.11(a)

Interview the CEO, or appropriate individual designated by the hospital, to determine

whether the hospital is in compliance with Federal laws related to patient health and safety.

(For example, ask if the hospital was cited since its last survey for any violation of Section

504 of the Rehabilitation Act of 1973 related to denying people with disabilities access to

care. If so, verify that satisfactory corrections have been made to bring the hospital into

compliance with that law.) Refer or report noted noncompliance with Federal laws and

regulations to the appropriate agency having jurisdiction (e.g., accessibility issues, blood-

borne pathogens, standard precautions, and TB control to OSHA; hazardous chemical/waste

issues to EPA; etc.)

A-0022

(Rev.172, Issued: 11-17-17, Effective: 11-17-17, Implementation: 11-17-17)

§482.11(b) The hospital must be--

(1) Licensed; or

(2) Approved as meeting standards for licensing established by the agency of the

State or locality responsible for licensing hospitals.

Interpretive Guidelines §482.11(b)

Hospitals applying for initial Medicare certification as a hospital or hospitals currently

participating in Medicare must, among other things, meet the statutory definition of a

hospital under section 1861(e) of the Act. Section 1861(e)(7) of the Act further requires

that a hospital located in a state which provides for the licensing of hospitals, the hospital

must be licensed in accordance with state law or approved as meeting standards for

licensing as established by the agency of the State or locality responsible for the licensing

of hospitals.

While a facility may have a license from a state to operate as a hospital or may have been

approved by a state as a hospital under state or local standards and authorities, that facility

may still not meet the Medicare definition of a hospital as per the Act. The criteria used by

a state to determine that a hospital meets the requirements for state licensure as a hospital is

not the same criteria used to define a hospital for the purpose of participation in Medicare,

and each state has its own criteria and standards for licensure.

The definition of a hospital and the issue of whether the facility is Primarily Engaged are

issues not applicable to a Critical Access Hospital (CAH).

Survey Procedures §482.11(b)

• Prior to the survey, determine whether the hospital has a current license by the state

or local authority in which it operates, or, if it is located within a

State that does not license hospitals, verify that the responsible State agency has

approved the hospital as meeting the State’s established standards for the licensing

of hospitals.

A-0023

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.11(c) The hospital must assure that personnel are licensed or meet

other applicable standards that are required by State or local laws.

Interpretive Guidelines §482.11(c)

All staff that are required by the State to be licensed must possess a current license. The

hospital must assure that these personnel are in compliance with the State’s licensure laws.

The laws requiring licensure vary from state to state. Examples of healthcare professionals

that a state may require to be licensed could include: nurses, MD/DOs, physician assistants,

dieticians, x-ray technologists, dentists, physical therapists, occupational therapists,

respiratory therapists and hospital administrators.

All staff must meet all applicable standards required by State or local law for hospital

personnel. This would include at a minimum:

• Certification requirements;

• Minimum qualifications;

• Training/education requirements; and

• Permits (such as food handlers permits).

When telemedicine is used and the practitioner and patient are located in different states,

the practitioner providing the patient care service must be licensed and/or meet 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.

Survey Procedures §482.11(c)

• Verify for those personnel required to be licensed, certified, and/or permitted by the

State, that the hospital has established, and follows procedures for determining that

personnel are properly licensed, certified, and/or permitted.

• Verify that staff and personnel are licensed, certified, and/or permitted in

accordance with State and local requirements.

• Verify that staff and personnel meet all standards (such as continuing education,

basic qualifications, etc.) required by State and local laws or regulations. Verify

that the hospital has a mechanism established and enforced to ensure compliance.

• Review a sample of personnel files to verify that licensure and/or other required

credentials information is up to date. Verify State licensure compliance of the direct

care personnel as well as administrators and supervisory personnel.

A-0043

(Rev. 122, Issued: 09-26-14, Effective: 09-26-14, Implementation: 09-26-14)

§482.12 Condition of Participation: Governing Body

There must be an effective governing body that is legally responsible for the conduct

of the hospital. If a hospital does not have an organized governing body, the persons

legally responsible for the conduct of the hospital must carry out the functions

specified in this part that pertain to the governing body.

Interpretive Guidelines §482.12

The hospital must have a governing body which is effective in carrying out its

responsibilities for the conduct of the hospital. In the absence of an organized governing

body, there must be written documentation that identifies the individual or individuals that

are legally responsible for the conduct of the hospital operations.

If the hospital is part of a healthcare system that includes several separately certified

hospitals, each with its own Medicare provider agreement and CMS Certification Number,

the governing body of the healthcare system has the option to act as the governing body of

each separately certified hospital, unless doing so would conflict with State law. A hospital

system also has the option to form several governing bodies, each of which is responsible

for several separately certified hospitals. For example, a health system operating hospitals

in many States might choose to form regional sub-boards each responsible for the hospitals

in its region, or a health system that has a mixture of types of hospitals may choose to form

one sub-board responsible for its short-term acute care hospitals and another for its long

term care hospitals.

When deciding whether or not to exercise the option to have a single governing body for

multiple hospitals in the system, another factor for systems to consider might be Medicare

payment requirements at §§412.22(e) - (h) applicable to certain types of hospitals, i.e., non-

grandfathered Hospitals-within-Hospitals and Hospital Satellites. In such cases where the

hospital system owns both the tenant and the host hospital, using a single governing body

for both hospitals would jeopardize the payment status of a hospital that is being paid by

Medicare under a payment system excluded from the Hospital Inpatient Prospective

Payment System (IPPS). However, surveyors do not assess compliance with or enforce the

Medicare payment regulations that govern Hospitals-within-Hospitals or Hospital Satellites.

The Medicare program offers hospital facilities considerable flexibility regarding how they

choose to participate. Based on the geographic and other institutional limitations set out in

the “provider-based” regulation at §413.65, which addresses provider-based status for

hospital facilities in multiple locations, hospital governing bodies make business decisions

about how they want to participate in Medicare, and they indicate on their Medicare

enrollment application the choices they have made. It is not uncommon to find multiple

hospital campuses with one owner located in the same geographic area enrolled in Medicare

as one hospital. It is also not uncommon to see a hospital system choosing to enroll its

various facilities as separately certified hospitals. Various factors enter into consideration

when the governing body of a system makes these decisions.

For example, some governing bodies prefer to enroll various campuses as separate

hospitals, out of a concern that problems at one hospital’s campus might jeopardize the

Medicare participation of the other campuses if they were a multi-campus hospital covered

under one Medicare provider agreement. In other cases a governing body may see the

benefits of integrating clinical services on multiple campuses into one integrated hospital.

In still other cases, the deciding factor might be the implications for Medicare

reimbursement of graduate medical education, the ease of adding satellite locations, etc.

CMS defers to the governing bodies of hospitals to weigh the pertinent factors and

permissible options, and to make business decisions in their best interest when applying to

participate in Medicare. CMS’s hospital certification decisions and issuance of a provider

agreement and associated CCN follow from these business decisions by a hospital’s

governing body. But once the “hospital,” with whatever component parts, has been

certified, that hospital must independently demonstrate its compliance with the CoPs,

independent of any other facility. (77 FR 29040, May 16, 2012)

If a hospital system has chosen to have a one body act as the governing body for multiple

separately certified hospitals (i.e., a system governing body), this does not alter the fact that

each hospital must independently demonstrate compliance with the CoPs. Examples of

what this means include, but are not limited to, the following:

• Each separately certified hospital must be separately and independently assessed

for its compliance with the CoPs, through either State Survey Agency or

approved Medicare hospital accreditation program surveys. There is no survey

of a hospital “system,” since the Medicare provider agreement and its terms are

specific to each certified hospital.

• A system governing body may wish to adopt identical policies and procedures

for many aspects of a hospital’s operations across all of its hospitals within the

system. It has the flexibility to do so, but the documentation of such policies

and procedures must be clear that the governing body has chosen to apply them

to specifically named hospitals. Also, each hospital must be able to present for

inspection the system governing body policies and procedures that clearly apply

to that hospital. For example:

A document that says “XX Healthsystem has adopted the following policy” is not

acceptable. Instead, the document must be more specific, such as, “XX

Healthsystem adopts the following policy and procedure for Hospital A, Hospital B,

and Hospital C.” Furthermore, the names of each hospital (Hospitals A, B, and C in

this example) must correspond to the names used for their provider agreements. For

example, if Hospital C is one Medicare-certified hospital with two inpatient

campuses, one called “East” and one called “West,” it is not acceptable for the

policy document to state, “XX Healthsystem adopts the following policy and

procedure for Hospital A, Hospital B, and Hospital East and Hospital West.” It

would be acceptable to state, “XX Healthsystem adopts the following policy and

procedure for Hospital A, Hospital B, and Hospital C.”

It also is not acceptable for the policy document to state, “XX Healthsystem adopts

the following policy and procedure for Hospital A, Hospital B, and Hospital East,

but not Hospital West.” Since “Hospitals” East and West refer to separate campuses

of Hospital C, which participates in Medicare as one multi-campus hospital, it is not

appropriate to refer to these separate campuses of C as “hospitals,” since the XX

Healthsystem made a business decision to enroll them as parts of one multi-campus

hospital in Medicare. CMS recognizes that, depending on the particular policy

topic, it may be acceptable to have policies that vary by type of unit/department

within a hospital. The system governing body could achieve this as follows: “XX

Healthsystem adopts the following policy and procedure requiring that a physician

be on-site 24 hours per day, seven days per week on the inpatient campuses of

Hospital A and Hospital B, but within Hospital C, only for the East inpatient

campus.”

• Likewise, the minutes of the governing body must be written in such a manner

so that it is clear when the governing body has taken actions that apply to a

specific certified hospital.

• Departments of separately certified hospitals with one system governing body

cannot be operationally integrated. For example, if a system has chosen to

operate three separately certified hospitals in relatively close proximity to each

other rather than to have them certified as one multi-campus hospital, then each

hospital must have its own nursing service. It may not have one integrated

nursing service with one Director of Nursing who manages one nursing staff for

all three hospitals. The system cannot maintain one integrated schedule that

assigns nursing staff among the different hospitals. The system also cannot

move them back and forth between hospitals on an ad hoc, as needed basis, as if

they were one hospital.

On the other hand, the policies and procedures the governing body has adopted for the

nursing service in each hospital may be identical, so long as the services operate

separately. It is also permissible for the same individual to be the Director of Nursing

for each hospital, provided that he or she is able to carry out all of the duties of the

position in each hospital, such as managing each hospital's separate nursing staff. It is

also permissible for one nurse to work at multiple hospitals within the system, in the

same way that a nurse may work for multiple hospitals that do not share ownership, but

the nurse must have separate work schedules for each hospital. Such schedules cannot

overlap.

• Likewise, although the system may choose to operate a quality

assessment/performance improvement (QAPI) program at the system level

which standardizes indicators measured across system hospitals, each

separately-certified hospital in the system must have a QAPI program that is

specific to that hospital. This is required not only to demonstrate compliance,

but also for the governing body to function effectively, since reviewing QAPI

program results only at the system level would make it difficult for the

governing body to identify and act upon problems that are localized to one

hospital.

For example, the system may choose to use the same quality indicators or the same

methodology to track adverse events across all system hospitals. But each certified

hospital must have its own QAPI data with respect to these indicators and adverse

events. If a system is tracking readmission rates across all of its hospitals, it must be

able to separate out the hospital-specific results for the governing body’s review and

possible action.

The governing body must be functioning effectively and holds the ultimate responsibility

for the hospital’s compliance not only with the specific standards of the governing body

CoP, but also with all of the CoPs. This is the case regardless of whether the regulatory text

for a particular condition or standard within a condition specifically mentions

responsibilities of the governing body. Substantial, i.e., condition-level, non-compliance

with one of the other hospital CoPs may be an indicator that the governing body is not

functioning effectively. However, it is not the policy of CMS that condition-level

noncompliance with any other CoP automatically results in a condition-level citation of the

governing body CoP. Surveyors must consider whether the manner and degree of the other

deficiencies provide sufficient evidence to conclude that the governing body is not

functioning effectively.

Survey Procedures §482.12

• Verify that the hospital has an organized governing body or has written

documentation that identifies the individual or individuals that are

responsible for the conduct of the hospital operations.

• If the hospital is part of a hospital system which uses one governing body for

several of the hospital’s separately certified within the system:

• Review the governing body minutes to determine if it is clear which actions pertain

to which hospitals.

• Select for review several policy and procedure documents adopted by the system

governing body to determine if it is clear that they apply to the hospital being

surveyed.

A-0044

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(a) Standard: Medical Staff. The governing body must:

Interpretive Guidelines §482.12(a)

The governing body must ensure the medical staff requirements are met.

A-0045

(Rev. 122, Issued: 09-26-14, Effective: 09-26-14, Implementation: 09-26-14)

[The governing body must:]

§482.12(a)(1) Determine, in accordance with State law, which categories of

practitioners are eligible candidates for appointment to the medical staff;

Interpretive Guidelines §482.12(a)(1)

The governing body must determine, in accordance with State law, which categories of

practitioners are eligible for appointment to the medical staff.

Physicians

The medical staff must, at a minimum, be composed of doctors of medicine or doctors of

osteopathy. In addition, the medical staff may include other types of practitioners included

in the definition of a physician in Section 1861(r) of the Social Security Act:

• Doctor of dental surgery or of dental medicine;

• Doctor of podiatric medicine;

• Doctor of optometry; and

• a Chiropractor.

In all cases, the practitioner included in the definition of a physician must be legally

authorized to practice within the State where the hospital is located and providing services

within their authorized scope of practice. In addition, in certain instances the Social

Security Act and regulations attach further limitations as to the type of hospital services for

which a practitioner may be considered to be a “physician.” See 42 CFR 482.12(c)(1) for

more detail on these limitations.

The governing body has the flexibility, consistent with State law, to determine whether

practitioners included in the definition of a physician other than a doctor of medicine or

osteopathy are eligible for appointment to the medical staff.

For Information Only – Not Required/ Not to be Cited

CMS expects that all physician practitioners granted privileges are also appointed as

members of the medical staff. However, if State law limits the composition of the

hospital’s medical staff to certain categories of practitioners, e.g., only MDs or DOs,

there is nothing in the CoPs that prohibits hospitals and their medical staffs from

establishing certain practice privileges for other categories of physician practitioners

excluded from medical staff membership under State law, or from granting those

privileges to individual practitioners in those categories, as long as such privileges are

recommended by the medical staff, approved by the governing body, and in accordance

with State law. (79 FR 27114 - 27115, May 12, 2014)

For physician practitioners granted privileges only, the hospital’s governing body and its

medical staff must exercise oversight, such as through credentialing and competency

review, of those other physician practitioners to whom it grants privileges, just as it would

for those practitioners appointed to its medical staff.

Non-physician practitioners

Furthermore, the governing body has the authority, in accordance with State law, to grant

medical staff privileges and membership to non-physician practitioners. The

corresponding regulation at 42 CFR 482.22(a) allows hospitals and their medical staffs to

take advantage of the expertise and skills of all types of practitioners who practice at the

hospital when making decisions concerning medical staff privileges and membership.

Granting medical staff privileges and membership to non-physician practitioners is an

option available to the governing body; it is not a requirement.

For Information Only – Not Required/ Not to be Cited

CMS expects that all practitioners granted privileges are also appointed as members of

the medical staff. However, if State law limits the composition of the hospital’s medical

staff to certain categories of practitioners, e.g., only physician practitioners, there is

nothing in the CoPs that prohibits hospitals and their medical staffs from establishing

certain practice privileges for those specific categories of non-physician practitioners

excluded from medical staff membership under State law, or from granting those

privileges to individual practitioners in those categories, as long as such privileges are

recommended by the medical staff, approved by the governing body, and in accordance

with State law. (79 FR 27114 - 27115, May 12, 2014)

For non-physician practitioners granted privileges only, the hospital’s governing body and

its medical staff must exercise oversight, such as through credentialing and competency

review, of those non-physician practitioners to whom it grants privileges, just as it would

for those practitioners appointed to its medical staff.

Practitioners are described in Section 1842(b)(18)(C) of the Act as any of the following:

• Physician assistant (as defined in Section 1861(aa)(5) of the Act);

• Nurse practitioner (as defined in Section 1861(aa)(5) of the Act);

• Clinical nurse specialist (as defined in Section 1861(aa)(5) of the Act);

• Certified registered nurse anesthetist (as defined in Section 1861(bb)(2) of the

Act);

• Certified nurse-midwife (as defined in Section 1861(gg)(2) of the Act);

• Clinical social worker (as defined in Section 1861(hh)(1) of the Act;

• Clinical psychologist (as defined in 42 CFR 410.71 for purposes of Section

1861(ii) of the Act);

• Anesthesiologist’s Assistant (as defined at §410.69); or

• Registered dietician or nutrition professional.

Other types of licensed healthcare professionals have a more limited scope of practice and

usually are not eligible for hospital medical staff privileges, unless their permitted scope of

practice in their State makes them more comparable to the above listed types of non-

physician practitioners. Some examples of types of such licensed healthcare professionals

who might be eligible for medical staff privileges, depending on State law and medical staff

bylaws, rules and regulations include, but are not limited to:

• Physical Therapist (as defined at §410.60 and §484.4);

• Occupational Therapist (as defined at §410.59 and §484.4); and

• Speech Language Therapist (as defined at §410.62 and §484.4).

Furthermore, some States have established a scope of practice for certain licensed

pharmacists who are permitted to provide patient care, services that make them more like

the above types of non-physician practitioners, including the monitoring and assessing of

patients and ordering medications and laboratory tests. In such States, a hospital may grant

medical staff privileges to such pharmacists and/or appoint them as members of the medical

staff. There is no standard term for such pharmacists, although they are sometimes referred

to as “clinical pharmacists.”

Practitioners may be granted active, courtesy, emergency, temporary, etc. membership or

privileges in accordance with state law and as specified in the medical staff bylaws, rules,

and regulations.

Survey Procedures §482.12(a)(1)

Review documentation and verify that the governing body has determined and stated the

categories of physicians and practitioners that are eligible candidates for appointment to the

medical staff or to be granted medical staff privileges.

A-0046

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[The governing body must:]

§482.12(a)(2) Appoint members of the medical staff after considering the

recommendations of the existing members of the medical staff;

Interpretive Guidelines §482.12(a)(2)

The governing body determines whether to grant, deny, continue, revise, discontinue, limit,

or revoke specified privileges, including medical staff membership, for a specific

practitioner after considering the recommendation of the medical staff. In all instances, the

governing body’s determination must be consistent with established hospital medical staff

criteria, as well as with State and Federal law and regulations. Only the hospital’s

governing body has the authority to grant a practitioner privileges to provide care in the

hospital.

Survey Procedures §482.12(a)(2)

• Review records of medical staff appointments to determine that the governing body

is involved in appointments of medical staff members.

• Confirm that there is evidence that the governing body considered recommendations

of the medical staff before making medical staff appointments.

A-0047

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[The governing body must:]

§482.12(a)(3) Assure that the medical staff has bylaws;

Interpretive Guidelines §482.12(a)(3)

The governing body must assure that the medical staff has bylaws and that those bylaws

comply with State and Federal law and the requirements of the Medicare hospital

Conditions of Participation.

Survey Procedures §482.12(a)(3)

Verify that the medical staff operates under current bylaws that are in accordance with

Federal and State laws and regulations.

A-0048

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[The governing body must:]

§482.12(a)(4) Approve medical staff bylaws and other medical staff rules

and regulations;

Interpretive Guidelines §482.12(a)(4)

The governing body decides whether or not to approve medical staff bylaws submitted by

the medical staff. The medical staff bylaws and any revisions must be approved by the

governing body before they are considered effective.

Survey Procedures and §482.12(a)(4)

• Verify that the medical staff operates under current bylaws, rules and policies that

have been approved by the governing body.

• Verify that any revisions or modifications in the medical staff bylaws, rules and

policies have been approved by the medical staff and the governing body, e.g.,

bylaws are annotated with date of last review and initialed by person(s) responsible.

A-0049

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[The governing body must:]

§482.12(a)(5) Ensure that the medical staff is accountable to the governing

body for the quality of care provided to patients;

Interpretive Guidelines §482.12(a)(5)

The governing body must ensure that the medical staff as a group is accountable to the

governing body for the quality of care provided to patients. The governing body is

responsible for the conduct of the hospital and this conduct includes the quality of care

provided to patients.

All hospital patients must be under the care of a practitioner who meets the criteria of 42

CFR 482.12(c)(1)and who has been granted medical staff privileges, 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 has been

granted privileges in accordance with the criteria established by the governing body, and

who is working within the scope of those granted privileges.

Survey Procedures §482.12(a)(5)

• Verify that the governing body is periodically apprised of the medical staff

evaluation of patient care services provided hospital wide, at every patient care

location of the hospital.

• Verify that any individual providing patient care services is a member of the

medical staff or is accountable to a member of the medical staff qualified to evaluate

the quality of services provided, and in turn, is responsible to the governing body for

the quality of services provided.

A-0050

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[The governing body must:]

§482.12(a)(6) Ensure the criteria for selection are individual character,

competence, training, experience, and judgment; and

Interpretive Guidelines §482.12(a)(6)

The governing body must assure that the medical staff bylaws describe the privileging

process to be used by the hospital. The process articulated in the medical staff bylaws,

rules, or regulations must include criteria for determining the privileges that may be granted

to individual practitioners and a procedure for applying the criteria to individual

practitioners that considers:

• Individual character;

• Individual competence;

• Individual training;

• Individual experience; and

• Individual judgment.

The governing body must ensure that the hospital’s bylaws governing medical staff

membership or the granting of privileges apply equally to all practitioners in each

professional category of practitioners.

Survey Procedures §482.12(a)(6)

• Verify that there are written criteria for appointments to the medical staff and

granting of medical staff privileges.

• Verify that granting of medical staff membership or privileges, both new and

renewal, is based upon an individual practitioner’s meeting the medical staff’s

membership/privileging criteria.

• Verify that, at a minimum, criteria for appointment to the medical staff/granting of

medical staff privileges are individual character, competence, training, experience,

and judgment.

A-0051

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[The governing body must:]

§482.12(a)(7) Ensure that under no circumstances is the accordance of

staff membership or professional privileges in the hospital dependent

solely upon certification, fellowship or membership in a specialty body or

society.

Interpretive Guidelines §482.12(a)(7)

In making a judgment on medical staff membership, a hospital may not rely solely on the

fact that a MD/DO is, or is not, board-certified. This does not mean that a hospital is

prohibited from requiring board certification when considering a MD/DO for medical staff

membership, but only that such certification must not be the only factor that the hospital

considers. In addition to matters of board certification, a hospital must also consider other

criteria such as training, character, competence and judgment. After analysis of all of the

criteria, if all criteria are met except for board certification, the hospital has the discretion to

decide not to select that individual to the medical staff.

Survey Procedures §482.12(a)(7)

Verify that written criteria for appointment to the medical staff and granting of medical

staff privileges are not dependent solely upon certification, fellowship, or membership in a

specialty body or society.

A-0052

(Rev.78, Issued: 12-22-11, Effective/Implementation: 12-22-11)

[The governing body must:]

§482.12(a)(8) Ensure that, 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 paragraphs (a)(1) through (a)(7) of this section

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 §482.22(a)(3) of this part, grant

privileges based on its medical staff recommendations that rely on information

provided by the distant-site hospital.

§482.12(a)(9) Ensure that 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 §482.12(e), furnishes the contracted

services in a manner that permits the hospital to comply with all applicable conditions

of participation for the contracted services, including, but not limited to, the

requirements in paragraphs (a)(1) through (a)(7) of this section 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 §482.22(a)(4) of this part, 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.

Interpretive Guidelines §482.12(a)(8)&(a)(9)

“Telemedicine,” as the term is used in this regulation, means the provision of clinical

services to patients by physicians and practitioners from a distance via electronic

communications. The distant-site telemedicine physician or practitioner provides clinical

services to the hospital patient either simultaneously, as is often the case with teleICU

services, for example, or non-simultaneously, as may be the case with many teleradiology

services. “Simultaneously” means that the clinical services (for example, assessment of the

patient with a clinical plan for treatment, including any medical orders needed) are provided

to the patient in “real time” by the telemedicine physician or practitioner, similar to the

actions of an on-site physician or practitioner. “Non-simultaneously” means that, while the

telemedicine physician or practitioner still provides clinical services to the patient upon a

formal request from the patient’s attending physician, such services may involve after-the-

fact interpretation of diagnostic tests in order to provide an assessment of the patient’s

condition and do not necessarily require the telemedicine practitioner to directly assess the

patient in “real time.” This would be similar to the services provided by an on-site

radiologist who interprets a patient’s x-ray or CT scan and then communicates his or her

assessment to the patient’s attending physician who then bases his or her diagnosis and

treatment plan on these findings. (See 76 FR 25551-25552, May 5, 2011)

A hospital may make arrangements through written agreements either with a distant-site

Medicare-participating hospital or a distant-site telemedicine entity for the provision of

telemedicine services to the hospital’s patients by physicians or practitioners who have been

granted privileges by the distant-site hospital or telemedicine entity. For the purposes of

this rule, a distant-site telemedicine entity is defined as an entity that -- (1) provides

telemedicine services; (2) is not a Medicare-participating hospital; and (3) provides

contracted services in a manner that enables a hospital using its services to meet all

applicable CoPs, particularly those requirements related to the credentialing and privileging

of practitioners providing telemedicine services to the patients of a hospital. A distant-site

telemedicine entity would include a distant-site hospital that does not participate in the

Medicare program that is providing telemedicine services to a Medicare-participating

hospital. (See 76 FR 25553, May 5, 2011)

If a hospital enters into an agreement for telemedicine services with a distant-site hospital

or telemedicine entity, the agreement must be in writing. Furthermore, the written

agreement must specify, in the case of a:

• Distant-site hospital, that it is the responsibility of the governing body of the

distant-site hospital to satisfy the requirements of §§482.12(a)(1) through (a) (7)

with respect to those physicians and practitioners at the distant-site hospital who

furnish telemedicine services under the agreement. Since the distant-site hospital

must also be a Medicare-participating hospital (see §482.22(a)(3)), it has an

independent obligation to comply with these governing body requirements

concerning medical staff membership and privileging. Nevertheless, the written

agreement between the hospital and the distant-site hospital must explicitly

include a provision addressing the distant-site hospital’s obligation to comply with

these provisions.

• Distant-site telemedicine entity, that the written agreement specifies that they

entity is a contractor providing telemedicine services to the hospital, and that, in

accordance with the requirements governing services under arrangement at

§482.12(e), the telemedicine entity furnishes the contracted telemedicine services

in a manner that permits the hospital to comply with the Conditions of

Participation, including, but not limited to, the governing body requirements of

§§482.12(a)(1) through (a) (7) with respect to those physicians and practitioners at

the distant-site telemedicine entity who furnish telemedicine services under the

agreement.

There are additional requirements for the content of the written agreement, specified at

§482.22(a)(3) and §482.22(a)(4) under the medical staff Condition of Participation, which

are discussed in the interpretive guidelines for those regulations.

The hospital’s governing body must grant privileges to each telemedicine physician or

practitioner providing services at the hospital under an agreement with a distant-site

hospital or telemedicine entity before they may provide telemedicine services. The scope

of the privileges in the hospital must reflect the provision of the services via a

telecommunications system. For example, a surgeon at a distant-site hospital may provide

telemedicine consultation services at a hospital under agreement, but obviously would not

be able to perform surgery by this means and must not have surgical privileges in the

hospital as part of his/her telemedicine services privileges. If the surgeon also periodically

performed surgery on-site at the hospital, then he or she would have to have privileges to do

so, granted in the traditional manner provided for at §482.12(a)(1) through §482.12(a)(7)

and §482.22(a)(1) and §482.22(a)(2).

In granting privileges to telemedicine physicians and practitioners, the hospital’s governing

body has the option of considering hospital medical staff recommendations that rely, in

accordance with §482.22(a)(3) and §482.22(a)(4), upon the credentialing and privileging

decisions of the distant-site hospital or telemedicine entity. With respect to the decisions of

a distant-site telemedicine entity, the regulation states that this streamlined privileging

option is available to the hospital for physicians and practitioners “employed” by the

distant-site telemedicine entity. We are interpreting “employed” in this context to mean

“utilized by” the distant-site telemedicine entity to provide telemedicine services to the

hospital under an agreement. Since it is common for telemedicine entities to contract with,

rather than employ, the physicians and practitioners it utilizes to provide telemedicine

services, it would not be reasonable or consistent with the regulatory intent to interpret

“employed” to mean that the physicians or practitioners are employees of the distant-site

telemedicine entity.

When the hospital’s governing body exercises the option to grant privileges based on its

medical staff recommendations that rely upon the privileging decisions of a distant-site

telemedicine hospital or entity, it may, but is not required to, maintain a separate file on

each telemedicine physician and practitioner, or may instead have a file on all telemedicine

physicians and practitioners providing services at the hospital under each agreement with a

distant-site hospital or telemedicine entity, indicating which telemedicine services

privileges the hospital has granted to each physician and practitioner on the list.

Relying upon the credentialing and privileging decisions of the distant-site hospital or

telemedicine entity is an option available to the hospital’s governing body, not a

requirement. A governing body may, if it so chooses, require its medical staff to

independently review the credentials of and make privileging recommendations for each

telemedicine physician and practitioner in accordance with §482.22(a)(1) and

§482.22(a)(2), rather than permit its medical staff to rely upon the privileging decisions of

the distant-site hospital or telemedicine entity. The agreement with the distant-site hospital

or telemedicine entity may not require the hospital to rely upon the distant-site

organization’s privileging decisions.

Survey Procedures §482.12(a)(8)&(a)(9)

• Ask the hospital’s leadership whether it uses telemedicine services. If yes:

• Ask to see a copy of the written agreement(s) with the distant-site hospital(s) or

telemedicine entity(ies). Does each agreement include the required elements

concerning credentialing and privileging of the telemedicine physicians and

practitioners?

• Does the hospital have documentation indicating that it granted privileges to each

telemedicine physician and practitioner?

• Does the documentation indicate that for each telemedicine physician and

practitioner there is a medical staff recommendation, including an indication of

whether the medical staff conducted its own review or relied upon the decisions of

the distant-site hospital or telemedicine entity?

A-0053

(Rev. 122, Issued: 09-26-14, Effective: 09-26-14, Implementation: 09-26-14)

[The governing body must:]

§482.12(a)(10) 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 this

paragraph (a).

Interpretive Guidelines §482.12(a)(10)

In accordance with §482.22(b)(3), there must be an individual member of the hospital’s

medical staff who is assigned responsibility for the organization and conduct of the

medical staff (for purposes of this guidance, the “leader” of the medical staff).

§482.12(a)(10) requires that the governing body consult with this individual, or with

someone the leader of the medical staff has designated.

“Direct consultation” means that the governing body, or a subcommittee of the governing

body, meets with the leader(s) of the medical staff(s), or his/her designee(s) either face-to-

face or via a telecommunications system permitting immediate, synchronous

communication. (79 FR 27113, May 12, 2014)

This regulation does not preclude a hospital from having a member of the medical staff

serve as a member of the hospital’s governing body. However, membership on the

governing body by a medical staff member is not sufficient per se to satisfy the requirement

for periodic consultation. In such a situation the hospital meets the consultation

requirement only if the medical staff member serving on the governing body is the leader of

the medical staff, or his or her designee, and only if such membership includes meeting

with the board periodically throughout the fiscal or calendar year and discussing matters

related to the quality of medical care provided to patients of the hospital. If there were a

change in the medical staff leadership or his/her designee, and the bylaws governing terms

and conditions of governing body membership did not allow for substitution of the new

leader of the medical staff (or his or her designee) on the governing body, then the

governing body would be expected to engage in direct consultation with the new leader of

the medical staff, or his or her designee.

It should be noted that if a hospital chooses to have the leader of the medical staff, or his or

her designee, serve on the governing body, there is nothing in the regulation which

prohibits the hospital from also including other medical staff members on the governing

body in addition to the leader of the medical staff, or his or her designee.

In the case of a multi-hospital system that has one single governing body, the governing

body must consult with each separately certified hospital’s medical staff leader, or his/her

designee. The consultations do not have to be separate. For example, the system governing

body could periodically have a meeting that includes the leader of the medical staff, or

his/her designee, from each hospital within the system, so long as there is discussion of

matters related to the quality of medical care provided to the patients of each hospital.

If the medical staff members at separately certified hospitals in a multi-hospital system and

the hospital system’s governing body also have opted to have a unified medical staff (see

guidance for §482.22(b)(4)) for some or all of the hospitals in the system, then the

governing body must consult with the leader of the unified medical staff or his/her

designee. In this case, the leader of the unified medical staff, or the designee, as applicable,

is expected to be aware of the concerns/views of members of the medical staff practicing at

each separately certified hospital using the unified medical staff.

It is up to the governing body as to whether the leader of the medical staff must make the

designation in writing when he or she chooses to designate another individual for these

periodic consultations, or whether the leader of the medical staff may make informal, ad

hoc designations. It is also up to the governing body as to whether it wishes to establish

minimum advance notice of a designation from the leader of the medical staff to the

governing body.

The requirement for the governing body to consult periodically throughout the year leaves

some flexibility for the governing body to determine how often during the year its

consultations with the leader of the medical staff or designee would occur, but it is expected

that consultations occur at least twice during either a calendar or fiscal year. (“Fiscal year”

refers to the Medicare cost-reporting year for the hospital; in the case of a hospital system

with multiple, separately certified hospitals that have one single governing body and a

unified medical staff, it is possible that individual hospitals have separate fiscal years. In

this case, it would be more practical for the governing body to use a calendar year basis for

determining the frequency of consultation.)

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).

The “year” referenced in the regulation may be either the calendar year or the hospital’s

fiscal year, as identified on its Medicare cost report. It is up to the hospital which approach

it will take, but it must document the approach selected and consistently apply it. For

example, if a hospital chooses to use the calendar year, and had only one consultation

during a calendar year, it could not then point out that it had had two meetings during the

time period covered by its fiscal year.

The required consultation must include discussion of matters related to the quality of

medical care provided to the hospital’s patients, or, in the case of a hospital system with one

single governing body and a unified medical staff, the quality of medical care provided to

each separately certified hospital’s patients.

The hospital’s governing body must adopt policies and procedures addressing how it

implements the requirement for periodic, direct consultation with the leader of the medical

staff, or the designee. The hospital must have evidence that the required consultations do

take place, such as meeting agendas and lists of attendees, or minutes taken of the

discussion, including who was present, etc., and that matters related to the quality of

medical care provided to patients of the hospital were discussed.

Survey Procedures §482.12(a)(10)

• Ask the hospital’s CEO how the hospital complies with the requirement for

periodic consultations by the governing body with the leader of the hospital’s

medical staff, or the leader’s designee. Can the CEO provide evidence that such

consultations have occurred, e.g., meeting agendas and lists of attendees,

meeting minutes, etc.

• Ask the CEO whether the hospital tracks these consultations by the calendar

year or its fiscal year; ask to see a copy of the policy that establishes this.

• Is there evidence that the consultations were “direct?”

• Is there evidence that the governing body met with the medical staff leader

or designee at least twice during the previous year?

• Is there evidence that the discussion concerned matters related to the quality

of medical care in the hospital?

• Ask the leader of the hospital’s medical staff, or his/her designee, whether he or

she has had meetings with either the whole governing body or a subcommittee

of it to discuss the quality of medical care in the hospital.

• Has the leader/designee ever requested a meeting in addition to those

regularly scheduled, to discuss a matter of urgent concern to the medical

staff? If yes, did the governing body respond by setting up a meeting?

If the hospital shares a unified medical staff with other separately certified hospitals in a

multi-hospital system, the interview with the leader of the medical staff, or designee, may

have to be conducted by telephone. Ask the leader/designee how he/she gathers

information about the concerns/views of members of the medical staff practicing at the

hospital being surveyed about the quality of medical care provided at that hospital.

A-0057

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(b) Standard: Chief Executive Officer

The governing body must appoint a chief executive officer who is responsible for

managing the hospital.

Interpretive Guidelines §482.12(b)

The Governing Body must appoint one chief executive officer who is responsible for

managing the entire hospital.

Survey Procedures §482.12(b)

• Verify that the hospital has only one chief executive officer for the entire hospital.

• Verify that the governing body has appointed the chief executive officer.

• Verify that the chief executive officer is responsible for managing the entire

hospital.

A-0063

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(c) Standard: Care of Patients

In accordance with hospital policy, the governing body must ensure that the following

requirements are met:

A-0064

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[…the governing body must ensure that the following requirements are met:]

§482.12(c)(1) Every Medicare patient is under the care of:

(i) A doctor of medicine or osteopathy. (This provision is not to be

construed to limit the authority of a doctor of medicine or osteopathy to

delegate tasks to other qualified health care personnel to the extent recognized

under State law or a State’s regulatory mechanism.);

(ii) A 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 or

her license;

(iii)A doctor of podiatric medicine, but only with respect to functions which he

or she is legally authorized by the State to perform;

(iv) A doctor of optometry who is legally authorized to practice optometry

by the State in which he or she practices;

(v) A chiropractor who is licensed by the State or 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; and

(vi) A clinical psychologist as defined in §410.71 of this chapter, but only

with respect to clinical psychologist services as defined in §410.71 of this

chapter and only to the extent permitted by State law.

Interpretive Guidelines §482.12(c)(1)

Practitioners other than doctors of medicine or osteopathy may join the medical staff if the

practitioners are appropriately licensed and medical staff membership is in accordance with

State law.

Every Medicare or Medicaid patient must be under the care of a licensed practitioner as

defined in this requirement.

Survey Procedures §482.12(c)(1)

Verify that Medicare patients are under the care of a licensed practitioner as defined by

(c)(1).

A-0065

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[…the governing body must ensure that the following requirements are met:]

§482.12(c)(2) Patients are admitted to the hospital only on the recommendation of

a licensed practitioner permitted by the State to admit patients to a hospital.

Survey Procedures §482.12(c)(2)

• Verify that admitting privileges are limited to those categories of practitioners as

allowed by State law.

• Verify that patients are admitted only by those practitioners who are currently

licensed and have been granted admitting privileges by the governing body in

accordance with State laws and medical staff bylaws.

A-0066

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[…the governing body must ensure that the following requirements are met:]

§482.12(c)(2) (continued)

If a Medicare patient is admitted by a practitioner not specified in paragraph

(c)(1) of this section, that patient is under the care of a doctor of medicine or

osteopathy.

Interpretive Guidelines §482.12(c)(2)

CMS hospital regulations do permit licensed practitioners (e.g., nurse practitioners,

midwives, etc), as allowed by the State, to admit patients to a hospital, and CMS does not

require these practitioners be employed by a MD/DO. However, CMS regulations do

require that Medicare and Medicaid patients admitted by these practitioners be under the

care of an MD/DO. Evidence of being under the care of an MD/DO must be in the

patient’s medical record. If a hospital allows these practitioners to admit and care for

patients, as allowed by State law, the governing body and medical staff would have to

establish policies and bylaws to ensure that the requirements of 42 CFR §482 are met.

Midwife Patients

42 CFR 482.1(a)(5) states, "Section 1905(a) of the Act provides that 'medical assistance'

(Medicaid) payments may be applied to various hospital services. Regulations interpreting

those provisions specify that hospitals receiving payment under Medicaid must meet the

requirements for participation in Medicare (except in the case of medical supervision of

nurse midwife services. See §§440.10 and 440.165 of this chapter)."

Midwives are not specified at 42 CFR §482.12(c)(1).

Section 482.1(a)(5), when taken together with this requirement (42 CFR 482.12(c)(2))

means that in a State that permits midwives to admit patients (and in accordance with

hospital policy and practitioner privileges), CMS requires ONLY Medicare patients of a

midwife be under the care of a doctor of medicine or osteopathy. CMS DOES NOT require

Medicaid or other non-Medicare patients admitted by a midwife to be under the care of a

doctor of medicine or osteopathy.

Survey Procedures §482.12(c)(2)

If the hospital grants admitting privileges to these practitioners, select Medicare and

Medicaid patients (select only Medicare patients for midwives) that are admitted to the

hospital by these practitioners. Determine if the patient is/was under the care of an

MD/DO.

A-0067

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[…the governing body must ensure that the following requirements are met:]

§482.12(c)(3) A doctor of medicine or osteopathy is on duty or on call at all times.

Survey Procedures §482.12(c)(3)

• Verify the governing body has established and monitors the enforcement of policies

that ensure a doctor of medicine or osteopathy is on duty or on call at all times to

provide medical care and onsite supervision when necessary.

• Review the “call” register and documents that assure that a doctor of medicine or

osteopathy is on duty or on call at all times.

• Interview nursing staff. How do they know who is on call? Are they able to call the

on-call MD/DO and speak with him/her at all times? When appropriate, do on-call

MD/DOs come to the hospital to provide needed care.

A-0068

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[…the governing body must ensure that the following requirements are met:]

§482.12(c)(4) A doctor of medicine or osteopathy is responsible for the care of each

Medicare patient with respect to any medical or psychiatric problem that--

(i) Is present on admission or develops during hospitalization; and

(ii) Is not specifically within the scope of practice of a doctor of dental

surgery, dental medicine, podiatric medicine, or optometry; a

chiropractor; or clinical psychologist, as that scope is--

(A) Defined by the medical staff;

(B) Permitted by State law; and

chiropractors.

Interpretive Guidelines §482.12(c)(4)

CMS hospital regulations do permit licensed practitioners (i.e., doctors of dental surgery,

dental medicine, podiatric medicine, or optometry; chiropractors; or clinical psychologists),

as allowed by the State, to admit patients to a hospital. However, CMS does require that

Medicare and Medicaid patients who are admitted by a doctor of dental surgery, dental

medicine, podiatric medicine, or optometry; a chiropractor; or clinical psychologist be

under the care of a MD/DO with respect to any medical or psychiatric problem that is

present on admission or develops during hospitalization that is outside the scope of practice

of the admitting practitioner. If a hospital allows a doctor of dental surgery, dental

medicine, podiatric medicine, or optometry, a chiropractor or a clinical psychologist to

admit and care for patients, as allowed by State law, the governing body and medical staff

must establish policies and bylaws to ensure that the requirements of 42 CFR §482 are met.

As applicable, the patient’s medical record must demonstrate MD/DO responsibility/care.

Survey Procedures §482.12(c)(4)

• Verify that an assigned doctor of medicine or osteopathy is responsible for and is

monitoring the care of each Medicare or Medicaid patient with respect to all medical

or psychiatric problems during the hospitalization.

• If non-MD/DOs admit patients, verify that every Medicare/Medicaid 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 practitioners.

A-0073

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(d) Standard: Institutional Plan and Budget

The institution must have an overall institutional plan that meets the following

conditions:

(1) The plan must include an annual operating budget that is prepared

according to generally accepted accounting principles.

(2) The budget must include all anticipated income and expenses. This

provision does not require that the budget identify item by item the components of

each anticipated income or expense.

(3) The plan must provide for capital expenditures for at least a 3-year period,

including the year in which the operating budget specified in paragraph (d)(2) of

this section is applicable.

(4) 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 a lesser amount that is established, in accordance with section

1122(g)(1) of the Act, by the State in which the hospital is located) that relates to

any of the following:

(i) Acquisition of land;

(ii) Improvement of land, buildings, and equipment; or

(iii)The replacement, modernization, and expansion of buildings and

equipment.

Survey Procedures §482.12(d)

Verify that an institutional plan and budget exist, includes items 1-4, and complies with all

items in this standard. Do not review the specifics or format in the institutional plan or the

budget.

A-0074

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(d)(5) The plan must be submitted for review to the planning agency

designated in accordance with section 1122(b) of the Act, or if an agency is not

designated, to the appropriate health planning agency in the State. (See Part 100 of

this title.)

Survey Procedures §482.12(d)(5)

Determine that the hospital’s plan for capital expenditures has been submitted to the

planning agency designated to review capital expenditures. In certain cases facilities used

by HMO and CMP patients are exempt from the review process.

A-0075

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(d)(5) (Continued)

A capital expenditure is not subject to section 1122 review if 75 percent of the

health care facility’s patients who are expected to use the service for which the

capital expenditure is made are individuals enrolled in a health maintenance

organization (HMO) or competitive medical plan (CMP) that meets the

requirements of section 1876(b) of the Act, and if the Department determines that

the capital expenditure is for services and facilities that are needed by the HMO or

CMP in order to operate efficiently and economically and that are not otherwise

readily accessible to the HMO or CMP because--

(i) The facilities do not provide common services at the same site;

(ii) The facilities are not available under a contract of reasonable duration;

(iii) Full and equal medical staff privileges in the facilities are not available;

(iv) Arrangements with these facilities are not administratively feasible; or

(v) The purchase of these services is more costly than if the HMO or CMP

provided the services directly.

A-0076

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(d)(6) The plan must be reviewed and updated annually

Survey Procedures §482.12(d)(6)

Verify that the plan and budget are reviewed and updated annually.

A-0077

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(d)(7) The plan must be prepared--

(i) Under the direction of the governing body; and

(ii) By a committee consisting of representatives of the governing body, the

administrative staff, and the medical staff of the institution.

Survey Procedures §482.12(d)(7)

Verify that the governing body, administrative staff, and medical staff have participated in

the development of the institutional plan and budget.

A-0083

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(e) Standard: Contracted Services

The governing body must be responsible for services furnished in the hospital whether

or not they are furnished under contracts. The governing body must ensure that a

contractor of services (including one for shared services and joint ventures) furnishes

services that permit the hospital to comply with all applicable conditions of

participation and standards for the contracted services.

Interpretive Guidelines §482.12(e)

The governing body has the responsibility for assuring that hospital services are provided in

compliance with the Medicare Conditions of participation and according to acceptable

standards of practice, irrespective of whether the services are provided directly by hospital

employees or indirectly by contract. The governing body must take actions through the

hospital’s QAPI program to: assess the services furnished directly by hospital staff and

those services provided under contract, identify quality and performance problems,

implement appropriate corrective or improvement activities, and to ensure the monitoring

and sustainability of those corrective or improvement activities. See §482.21 QAPI.

Survey Procedures §482.12(e)

Ascertain that all contractor services provided in the hospital are in compliance with the

Conditions of Participation for hospitals.

A-0084

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(e)(1) The governing body must ensure that the services performed under

a contract are provided in a safe and effective manner.

Interpretive Guidelines §482.12(e)(1)

Indirect arrangements may take into consideration services provided through formal

contracts, joint ventures, informal agreements, shared services, or lease arrangements. The

patient care services, and all other services, provided under contract are subject to the same

hospital-wide quality assessment and performance improvement (QAPI) evaluation as other

services provided directly by the hospital.

Survey Procedures §482.12(e)(1)

• Determine if the hospital has a mechanism to evaluate the quality of each contracted

service and ensures that each contracted service is provided in a safe and effective

manner.

• Review the QAPI plan to ensure that every contracted service is evaluated.

A-0085

§482.12(e)(2) The hospital must maintain a list of all contracted services, including

the scope and nature of the services provided.

Survey Procedures §482.12(e)(2)

Review the list of contracted services and verify that there is a delineation of contractor

responsibility.

A-0091

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(f) Standard: Emergency Services

Interpretive Guidelines §482.12(f )

The hospital must ensure the emergency services requirements are met.

A-0092

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(f)(1) If emergency services are provided at the hospital, the hospital must

comply with the requirements of §482.55.

A-0093

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(f)(2) If emergency services are not provided at the hospital, 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 §482.12(f)(2)

This requirement applies hospital-wide (all on-campus and off-campus locations) to

hospitals that do not provide emergency services.

Hospitals without emergency departments must have appropriate policies and procedures in

place for addressing individuals’ emergency care needs 24 hours per day and 7 days per

week, including the following:

• Appraisal of Persons with Emergencies: A hospital must have medical staff

policies and procedures for conducting appraisals of persons with emergencies.

The policies and procedures must ensure that:

o As required by 42 CFR 482.23(b), an RN is immediately available, as needed, to

provide bedside care to any patient and that,

o Among such RN(s) who are immediately available at all times, there must be an

RN(s) who is/are qualified, through a combination of education, licensure, and

training, to conduct an assessment that enables them to recognize the fact that a

person has a need for emergency care.

The policies and procedures for appraisal should provide that the MD/DO (on-site

or on-call) would directly provide appraisals of emergencies or provide medical

direction of on-site staff conducting appraisals.

• Initial Treatment: A hospital must have medical staff policies and procedures for

providing the initial treatment needed by persons with emergency conditions.

Among the RN(s) who must be available at all times in a hospital as required by 42

CFR 482.23(b), there must be RN(s) who are qualified, through a combination of

education, licensure, and training, to provide initial treatment to a person

experiencing a medical emergency. The on-site or on-call physician could provide

initial treatment directly or provide medical oversight and direction to other staff.

This requirement, taken together with other hospital regulatory requirements,

suggests that a prudent hospital would evaluate the patient population the hospital

routinely cares for in order to anticipate potential emergency care scenarios and

develop the policies, procedures, and staffing that would enable it to provide safe

and adequate initial treatment of an emergency.

• Referral when Appropriate: A hospital must have medical staff policies and

procedures to address situations in which a person’s emergency needs may exceed

the hospital’s capabilities. The policies and procedures should be designed to

enable hospital staff members who respond to emergencies to: (a) recognize when

a person requires a referral or transfer, and (b) assure appropriate handling of the

transfer. This includes arrangement for appropriate transport of the patient. Further,

in accordance with the Discharge Planning CoP at 42 CFR 482.43(d), the hospital

must transfer patients to appropriate facilities, i.e., those with the appropriate

capabilities to handle the patient’s condition. The regulation also requires that

necessary medical information be sent along with the patient being transferred. This

enables the receiving hospital to treat the medical emergency more efficiently.

• Patient Transportation and Emergency Medical Services (EMS)

A hospital may arrange transportation of the referred patient by several methods,

including using the hospital’s own ambulance service, the receiving hospital’s

ambulance service, a contracted ambulance service, or, in extraordinary

circumstances, alerting EMS via calling 9-1-1. There is no specific Medicare

prohibition on a hospital with or without an emergency department calling 9-1-1 in

order to obtain transport of a patient to another hospital. Use of 9-1-1 to obtain

transport does not, however, relieve the hospital of its obligation to arrange for the

patient’s transfer to an appropriate facility and to provide the necessary medical

information along with the patient.

A hospital policy or practice that relies on calling 9-1-1 in order for EMS to

substitute its emergency response capabilities for those the hospital is required to

maintain, as described above, is not consistent with the Medicare CoPs. For

example, a hospital may not rely upon 9-1-1 to provide appraisal and initial

treatment of medical emergencies that occur at the hospital. Such policy or

practice should be considered as condition-level non-compliance with the

applicable CoP, 42 CFR 482.55 or 42 CFR 482.12(f).

Survey Procedures §482.12(f)(2)

• Verify that the medical staff has adopted written policies and procedures for the

management of medical emergencies.

• Review emergency care policies and procedures. Are they consistent with the

expectations articulated above for appraisal, initial treatment, and referral? Do they

address emergency procedures for all on-campus and off-campus locations?

• Interview hospital staff at various locations. Can they state their duties and what

they are to do if an individual seeks or needs emergency care at their location?

A-0094

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.12(f)(3) If emergency services are provided at the hospital but are not provided

at one or more off-campus departments of the hospital, the governing body of the

hospital must assure that the medical staff has written policies and procedures in

effect with respect to the off-campus department(s) for appraisal of emergencies and

referral when appropriate.

Interpretive Guidelines §482.12(f)(3)

This requirement applies to any off-campus hospital department/location that does not

qualify as a dedicated emergency department in accordance with 42 CFR 489.24(b) and is

part of a hospital that provides emergency services. Such departments/locations must have

and must implement medical staff policies and procedures for the appraisal of emergencies

and referral when appropriate.

• Appraisal of Persons with Emergencies: A hospital must have medical staff policies

and procedures for conducting appraisals of persons with emergencies at off-campus

departments/locations that are not dedicated emergency departments. The policies and

procedures must ensure that clinical personnel -- who are qualified, through a

combination of education, licensure, and training, to conduct an assessment that enables

them to recognize the fact that a person has a need for emergency care -- are available

during all hours of operation at the off-campus department/location.

• Referral when Appropriate: A hospital must have medical staff policies and

procedures to address situations in which a person’s emergency needs may exceed the

capabilities of the off-campus departments/locations that are not dedicated emergency

departments. The policies and procedures should be designed to enable staff members

at such locations to: (a) recognize when a person requires a referral or transfer, and (b)

assure appropriate handling of the transfer. This includes arrangement for appropriate

transport of the patient along with the transfer of the patient’s medical information so

that the receiving hospital may treat the medical emergency more efficiently.

• Initial Treatment: Although there is no specific regulatory requirement for such off-

campus departments or locations to provide initial treatment of emergencies,

nevertheless they are expected to provide treatment and stabilization consistent with the

complexity of services, the type and qualifications of clinical staff, and the resources

available at that location. This expectation is based on the requirements of the

Outpatient Services CoP that hospital outpatient services meet the needs of the patients

in accordance with acceptable standards of practice, outpatient services must be

appropriately organized and integrated with inpatient services, and outpatient services

must have appropriate professional and nonprofessional personnel available. For

example, an off-campus cardiac rehabilitation clinic would be expected to have the

appropriate qualified staff, equipment (such as a crash cart), and policies and procedures

in place to appropriately provide appraisal, initial interventions, and referral of a patient

who experiences a cardiac emergency.

• A hospital policy or practice that relies on calling 9-1-1 in order for EMS to substitute

its emergency response capabilities for those the hospital is required to maintain at its

off-campus departments/locations, as described above, is not consistent with the

Medicare CoPs. However, given the more limited emergency capabilities that may be

present in some off-campus departments or locations, calling 9-1-1 to respond to an

emergency might be appropriate.

See the hospital emergency services CoP (42 CFR 482.55) for the emergency requirements

for the hospital’s locations that provide emergency services.

Survey Procedures §482.12(f)(3)

• Review emergency care policies and procedures. Determine if they address

emergency procedures for all off-campus locations.

• Interview off-campus hospital department staff. Can they state their duties and what

they are to do if an individual seeks emergency care?

A-0115

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.13 Condition of Participation: Patient's Rights

A hospital must protect and promote each patient’s rights.

Interpretive Guidelines §482.13

These requirements apply to all Medicare or Medicaid participating hospitals including

short-term, acute care, surgical, specialty, psychiatric, rehabilitation, long-term, children's

and cancer, whether or not they are accredited. This rule does not apply to critical access

hospitals. (See Social Security Act (the Act) §1861(e).)

These requirements, as well as the other Conditions of Participation in 42 CFR 482, apply

to all parts and locations (outpatient services, provider-based entities, inpatient services) of

the Medicare participating hospital.

Survey Procedures §482.13

Survey of the Patients’ Rights Condition of Participation (CoP) should be coordinated by

one surveyor. However, each surveyor, as he/she conducts his/her survey assignments,

should assess the hospital’s compliance with the Patients’ Rights CoP.

A-0116

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.13(a) Standard: Notice of Rights

Interpretive Guidelines §482.13(a)

The hospital must ensure the notice of rights requirements are met.

A-0117

(Rev. 75, Issued: 12-02-11, Effective: 12-02-11, Implementation: 12-02-11)

§482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s

representative (as allowed under State law), of the patient’s rights, in advance of

furnishing or discontinuing patient care whenever possible.

Interpretive Guidelines §482.13(a)(1)

The hospital must inform each patient, or when appropriate, the patient’s representative as

allowed by State law, of the patient’s rights. Whenever possible, this notice must be

provided before providing or stopping care. All patients, inpatient or outpatient, must be

informed of their rights as hospital patients. The patient’s rights include all of those

discussed in this condition, as well as any other rights for which notice is required under

State or Federal law or regulations for hospital patients. (See 42 CFR 482.11.) The

patient’s rights should be provided and explained in a language or manner that the patient

(or the patient’s representative) can understand. This is consistent with the guidance related

to Title VI of the Civil Rights Act of 1964 issued by the Department of Health and Human

Services - “Guidance to Federal Financial Assistance Recipients Regarding Title VI

Prohibition Against National Origin Discrimination Affecting Limited English Proficient

Persons” (August 8, 2003, 68 FR 47311). In accordance with §482.11, hospitals are

expected to comply with Title VI and may use this guidance to assist it in ensuring patient’s

rights information is provided in a language and manner that the patient understands.

Surveyors do not assess compliance with these requirements on limited English proficiency,

but may refer concerns about possible noncompliance to the Office for Civil Rights in the

applicable Department of Health and Human Services Regional Office.

Hospitals are expected to take reasonable steps to determine the patient’s wishes concerning

designation of a representative. Unless prohibited by applicable State law:

• When a patient who is not incapacitated has designated, either orally to hospital staff or

in writing, another individual to be his/her representative, the hospital must provide the

designated individual with the required notice of patients’ rights in addition to the

patient. The explicit designation of a representative takes precedence over any non-

designated relationship and continues throughout the patient’s inpatient stay or

outpatient visit, unless expressly withdrawn, either orally or in writing, by the patient.

• In the case of a patient who is incapacitated, when an individual presents the hospital

with an advance directive, medical power of attorney or similar document executed by

the patient and designating an individual to make medical decisions for the patient when

incapacitated, then the hospital must, when presented with the document, provide the

required notice of its policies to the designated representative. The explicit designation

of a representative takes precedence over any non-designated relationship and continues

throughout the patient’s inpatient stay or outpatient visit, unless the patient ceases to be

incapacitated and expressly withdraws the designation, either orally or in writing.

• When a patient is incapacitated or otherwise unable to communicate his or her wishes,

there is no written advance directive on file or presented, and an individual asserts that

he or she is the patient’s spouse, domestic partner (whether or not formally established

and including a same-sex domestic partner), parent (including someone who has stood

in loco parentis for the patient who is a minor child), or other family member and thus is

the patient’s representative, the hospital is expected to accept this assertion, without

demanding supporting documentation, and provide the required notice to the individual,

unless:

• More than one individual claims to be the patient’s representative. In such cases, it

would be appropriate for the hospital to ask each individual for documentation

supporting his/her claim to be the patient’s representative. The hospital should

make its determination of who is the patient’s representative based upon the

hospital’s determination of who the patient would most want to make decisions on

his/her behalf. Examples of documentation a hospital might consider could include,

but are not limited to, the following: proof of a legally recognized marriage,

domestic partnership, or civil union; proof of a joint household; proof of shared or

co-mingled finances; and any other documentation the hospital considers evidence

of a special relationship that indicates familiarity with the patient’s preferences

concerning medical treatment;

• Treating the individual as the patient’s representative without requesting supporting

documentation would result in the hospital violating State law. State laws,

including State regulations, may specify a procedure for determining who may be

considered to be the incapacitated patient’s representative, and may specify when

documentation is or is not required; or

• The hospital has reasonable cause to believe that the individual is falsely claiming to

be the patient’s spouse, domestic partner, parent or other family member.

Hospitals are expected to adopt policies and procedures that facilitate expeditious and

non-discriminatory resolution of disputes about whether an individual is the patient’s

representative, given the critical role of the representative in exercising the patient’s

rights.

A refusal by the hospital of an individual’s request to be treated as the patient’s

representative, based on one of the above-specified familial relationships, must be

documented in the patient’s medical record, along with the specific basis for the refusal.

In addition, according to the regulation at 42 CFR 489.27(a), (which cross references the

regulation at 42 CFR 405.1205), each Medicare beneficiary who is an inpatient (or his/her

representative) must be provided the standardized notice, “An Important Message from

Medicare” (IM), within 2 days of admission. Medicare beneficiaries who have not been

admitted (e.g., patients in observation status or receiving other care on an outpatient basis)

are not required to receive the IM. The IM is a standardized, OMB-approved form and

cannot be altered from its original format. The IM is to be signed and dated by the patient

to acknowledge receipt. See Exhibit 16 for a copy of the IM. Furthermore, 42 CFR

405.1205(c) requires that hospitals present a copy of the signed IM in advance of the

patient’s discharge, but not more than two calendar days before the patient’s discharge. In

the case of short inpatient stays, however, where initial delivery of the IM is within 2

calendar days of the discharge, the second delivery of the IM is not required.

The hospital must establish and implement policies and procedures that effectively ensure

that patients and/or their representatives have the information necessary to exercise their

rights.

Survey Procedures §482.13(a)(1)

• Determine the hospital’s policy for notifying all patients of their rights, both inpatient

and outpatient;

• Determine that the hospital’s policy provides for determining when a patient has a

representative and who that representative is, consistent with this guidance and State

law.

• Determine that the information provided to the patients by the hospital complies with

Federal and State law;

• Review records and interview staff to examine how the hospital communicates

information about their rights to diverse patients, including individuals who need

assistive devices or translation services. Does the hospital have alternative means, such

as written materials, signs, or interpreters (when necessary), to communicate patients’

rights?

• Review records and interview staff and patients or patients’ representatives (as

appropriate) to examine how the hospital determines whether the patient has a

representative, who that representative is, and whether notice of patients’ rights is

provided as required to patients’ representatives.

• Ask patients to tell you what the hospital has told them about their rights;

• Does staff know what steps to take to inform a patient about their patients’ rights,

including those patients’ with special communication needs?; and

• Review a sample of inpatient medical records for Medicare beneficiaries, to determine

whether the records contain a signed and dated IM provided within 2 days of the

admission of the patient. For patients whose discharge occurred more than 2 days after

the initial IM notice was issued, determine whether the hospital provided another copy

of the IM to the patient prior to discharge in a timely manner.

A-0118

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.13(a)(2) The hospital must establish a process for prompt resolution of patient

grievances and must inform each patient whom to contact to file a grievance.

Interpretive guidelines §482.13(a)(2)

The patient should have reasonable expectations of care and services and the facility should

address those expectations in a timely, reasonable, and consistent manner. Although

482.13(a)(2)(ii) and (iii) address documentation of facility time frames for a response to a

grievance, the expectation is that the facility will have a process to comply with a relatively

minor request in a more timely manner than a written response. For example, a change in

bedding, housekeeping of a room, and serving preferred food and beverage may be made

relatively quickly and would not usually be considered a "grievance" and therefore would

not require a written response.

The hospital must inform the patient and/or the patient's 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 provide the patient or the patient's

representative a phone number and address for lodging a grievance with the State agency.

The hospital must inform the patient that he/she may lodge 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.

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, regarding the patient's care (when

the complaint is not resolved at the time of the complaint by staff present), abuse or neglect,

issues related to the hospital's compliance with the CMS Hospital Conditions of

Participation (CoPs), or a Medicare beneficiary billing complaint related to rights and

limitations provided by 42 CFR 489.

• "Staff present" includes any hospital staff present at the time of the complaint or

who can quickly be at the patient's location (i.e., nursing, administration, nursing

supervisors, patient advocates, etc.) to resolve the patient's complaint.

• If a patient care complaint cannot be resolved at the time of the complaint by staff

present, is postponed for later resolution, is referred to other staff for later

resolution, requires investigation, and/or requires further actions for resolution, then

the complaint is a grievance for the purposes of these requirements. A complaint is

considered resolved when the patient is satisfied with the actions taken on their

behalf.

• Billing issues are not usually considered grievances for the purposes of these

requirements. However, a Medicare beneficiary billing complaint related to rights

and limitations provided by 42 CFR 489 is considered a grievance.

• A written complaint is always considered a grievance. This includes written

complaints from an inpatient, an outpatient, a released/discharged patient, or a

patient’s representative regarding the patient care provided, abuse or neglect, or the

hospital's compliance with CoPs. For the purposes of this requirement, an email or

fax is considered "written."

• Information obtained from patient satisfaction surveys usually does not meet the

definition of a grievance. If an identified patient writes or attaches a written

complaint on the survey and requests resolution, then the complaint meets the

definition of a grievance. If an identified patient writes or attaches a complaint to

the survey but has not requested resolution, the hospital must treat this as a

grievance if the hospital would usually treat such a complaint as a grievance.

• Patient complaints that are considered grievances also include situations where a

patient or a patient's representative telephones the hospital with a complaint

regarding the patient’s care or with an allegation of abuse or neglect, or failure of

the hospital to comply with one or more CoPs, or other CMS requirements. Those

post-hospital verbal communications regarding patient care that would routinely

have been handled by staff present if the communication had occurred during the

stay/visit are not required to be defined as a grievance.

• All verbal or written complaints regarding abuse, neglect, patient harm, or hospital

compliance with CMS requirements are considered grievances for the purposes of

these requirements.

• Whenever the patient or the patient's representative requests that his or her

complaint be handled as a formal complaint or grievance or when the patient

requests a response from the hospital, the complaint is considered a grievance and

all the requirements apply.

• Data collected regarding patient grievances, as well as other complaints that are not

defined as grievances (as determined by the hospital), must be incorporated in the

hospital's Quality Assessment and Performance Improvement (QAPI) Program.

Survey Procedures §482.13(a)(2)

• Review the hospital’s policies and procedures to assure that its grievance process

encourages all personnel to alert appropriate staff concerning any patient grievance.

Does the hospital adhere to its policy/procedure established for grievances?

• Interview patients or the patient’s legal representative to determine if they know

how to file a complaint (grievance) and who to contact if they have a complaint

(grievance).

• Is the hospital following its grievance policies and procedures?

• Does the hospital’s process assure that grievances involving situations or practices

that place the patient in immediate danger are resolved in a timely manner?

• Does the patient or the patient’s representative know that he/she has the right to file

a complaint with the State agency as well as or instead of utilizing the hospital’s

grievance process?

• Has the hospital provided the telephone number for the State agency to all

patients/patient representatives?

• Are beneficiaries aware of their right to seek review by the QIO for quality of care

issues, coverage decisions, and to appeal a premature discharge?

A-0119

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.13(a)(2) (Continued)

[The hospital must establish a process for prompt resolution of patient grievances and

must inform each patient whom to contact to file a grievance.] The hospital’s

governing body must approve and be responsible for the effective operation of the

grievance process, and must review and resolve grievances, unless it delegates the

responsibility in writing to a grievance committee.

Interpretive guidelines §482.13(a)(2)

The hospital's grievance process must be approved by the governing body. The hospital's

governing body is responsible for the effective operation of the grievance process. This

includes the hospital's compliance with all of the CMS grievance process requirements. The

hospital's governing body must review and resolve grievances, unless it delegates this

responsibility in writing to a grievance committee. A committee is more than one person.

The committee membership should have adequate numbers of qualified members to review

and resolve the grievances the hospital receives (this includes providing written responses)

in a manner that complies with the CMS grievance process requirements.

Survey Procedures §482.13(a)(2)

• Determine if the hospital’s governing body approved the grievance process.

• Is the governing body responsible for the operation of the grievance process, or has

the governing body delegated the responsibility in writing to a grievance

committee?

• Determine how effectively the grievance process works. Are patient's or the patient

representative’s concerns addressed in a timely manner? Are patients informed of

any resolution to their grievances? Does the hospital apply what it learns from the

grievance as part of its continuous quality improvement activities?

• Is the grievance process reviewed and analyzed through the hospital’s QAPI process

or some other mechanisms that provides oversight of the grievance process?

A-0120

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.13(a)(2) (Continued)

[The hospital must establish a process for prompt resolution of patient grievances and

must inform each patient whom to contact to file a grievance. The hospital’s

governing body must approve and be responsible for the effective operation of the

grievance process, and must review and resolve grievances, unless it delegates the

responsibility in writing to a grievance committee.] The grievance process must

include a mechanism for timely referral of patient concerns regarding quality of care

or premature discharge to the appropriate Utilization and Quality Control Quality

Improvement Organization. At a minimum:

Interpretive Guidelines §482.13(a)(2)

Quality Improvement Organizations (QIOs) are CMS contractors charged with reviewing

the appropriateness and quality of care rendered to Medicare beneficiaries in the hospital

setting. The QIOs are also tasked with reviewing utilization decisions. Part of this duty

includes reviewing discontinuation of stay determinations based upon a beneficiary’s

request. The regulations state the functions of the QIOs in order to make Medicare

beneficiaries aware of the fact that if they have a complaint regarding quality of care,

disagree with a coverage decision, or they wish to appeal a premature discharge, they may

contact the QIO to lodge a complaint. The hospital is required to have procedures for

referring Medicare beneficiary concerns to the QIOs; additionally, CMS expects

coordination between the grievance process and existing grievance referral procedures so

that beneficiary complaints are handled timely and referred to the QIO at the beneficiary’s

request.

This regulation requires coordination between the hospital’s existing mechanisms for

utilization review notice and referral to QIOs for Medicare beneficiary concerns (See

42 CFR Part 489.27). This requirement does not mandate that the hospital automatically

refer each Medicare beneficiary’s grievance to the QIO; however, the hospital must inform

all beneficiaries of this right, and comply with his or her request if the beneficiary asks for

QIO review.

Medicare patients have the right to appeal a premature discharge (see Interpretive

Guidelines for 42 CFR 482.13(a)). Pursuant to 42 CFR 412.42(c)(3), a hospital must

provide a hospital-issued notice of non-coverage (HINN) to any fee-for-service beneficiary

that expresses dissatisfaction with an impending hospital discharge. Medicare Advantage

(MA) organizations are required to provide enrollees with a notice of non-coverage, known

as the Notice of Discharge and Medicare Appeal Rights (NODMAR), only when a

beneficiary disagrees with the discharge decision or when the MA organization (or hospital,

if the MA organization has delegated to it the authority to make the discharge decision) is

not discharging the enrollee, but no longer intends to cover the inpatient stay.

Survey Procedures §482.13(a)(2)

• Review patient discharge materials. Is the hospital in compliance with 42 CFR

§489.27?

• Does the hospital grievance process include a mechanism for timely referral of

Medicare patient concerns to the QIO? What time frames are established?

• Interview Medicare patients. Are they aware of their right to appeal premature

discharge?

A-0121

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[At a minimum:]

§482.13(a)(2)(i) The hospital must establish a clearly explained procedure for the

submission of a patient’s written or verbal grievance to the hospital.

Interpretive Guidelines §482.13(a)(2)(i)

The hospital’s procedure for a patient or the patient’s representative to submit written or

verbal grievances must be clearly explained. The patient or patient’s representative should

be able to clearly understand the procedure.

Survey Procedures §482.13(a)(2)(i)

• Review the information provided to patients that explains the hospital’s grievance

procedures. Does it clearly explain how the patient is to submit either a verbal or

written grievance?

• Interview patients or patient representatives. Does the patient, or (if he/she is

incapacitated) his/her representative, know about the grievance process and how to

submit a grievance?

A-0122

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[At a minimum:]

§482.13(a)(2)(ii) The grievance process must specify time frames for review of the

grievance and the provision of a response.

Interpretive Guidelines §482.13(a)(2)(ii)

The hospital must review, investigate, and resolve each patient’s grievance within a

reasonable time frame. For example, grievances about situations that endanger the patient,

such as neglect or abuse, should be reviewed immediately, given the seriousness of the

allegations and the potential for harm to the patient(s). However, 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.

Document when a grievance is so complicated that it may require an extensive

investigation. We recognize that staff scheduling as well as fluctuations in the numbers and

complexity of grievances can affect the timeframes for the resolution of a grievance and the

provision of a written response. On average, a time frame of 7 days for the provision of the

response would be considered appropriate. We do not require that every grievance be

resolved during the specified timeframe although most should be resolved. 42 CFR

482.13(a)(2)(iii) specifies information the hospital must include in their response.

If the grievance will not be resolved, or if the investigation is not or will not be completed

within 7 days, the hospital should inform the patient or the patient's representative that the

hospital is still working to resolve the grievance and that the hospital will follow-up with a

written response within a stated number of days in accordance with the hospital's grievance

policy. The hospital must attempt to resolve all grievances as soon as possible.

Survey Procedures §482.13(a)(2)(ii)

What time frames are established to review and respond to patient grievances? Are these

time frames clearly explained in the information provided to the patient that explains the

hospital’s grievance process? On average, does the hospital provide a written response to

most of its grievances within the timeframe specified in its policy?

A-0123

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

[At a minimum:]

§482.13(a)(2)(iii) In its resolution of the grievance, the hospital must provide the

patient with written notice of its decision that contains the name of the hospital

contact person, the steps taken on behalf of the patient to investigate the grievance, the

results of the grievance process, and the date of completion.

Interpretive Guidelines §482.13(a)(2)(iii)

The written notice of the hospital’s determination regarding the grievance must be

communicated to the patient or the patient’s representative in a language and manner the

patient or the patient’s legal representative understands.

The hospital may use additional tools to resolve a grievance, such as meeting with the

patient and his family. The regulatory requirements for the grievance process are minimum

standards, and do not inhibit the use of additional effective approaches in handling patient

grievances. However, in all cases the hospital must provide a written notice (response) to

each patient’s grievance(s). The written response must contain the elements listed in this

requirement.

When a patient communicates a grievance to the hospital via email the hospital may

provide its response via email pursuant to hospital policy. (Some hospitals have policies

against communicating to patients over email.) If the patient requests a response via email,

the hospital may respond via email. When the email response contains the information

stated in this requirement, the email meets the requirement for a written response. The

hospital must maintain evidence of its compliance with these requirements.

A grievance is considered resolved when the patient is satisfied with the actions taken on

their behalf.

There may be situations where the hospital has taken appropriate and reasonable actions on

the patient's behalf in order to resolve the patient's grievance and the patient or the patient's

representative remains unsatisfied with the hospital's actions. In these situations, the

hospital may consider the grievance closed for the purposes of these requirements. The

hospital must maintain documentation of its efforts and demonstrate compliance with CMS

requirements.

In its written response, the hospital is not required to include statements that could be used

in a legal action against the hospital, but the hospital must provide adequate information to

address each item stated in this requirement. The hospital is not required to provide an

exhaustive explanation of every action the hospital has taken to investigate the grievance,

resolve the grievance, or other actions taken by the hospital.

Survey Procedures §482.13(a)(2)(iii)

Review the hospital’s copies of written notices (responses) to patients. Are all patients

provided a written notice? Do the notices comply with the requirements?

A-0129

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.13(b) Standard: Exercise of Rights

Interpretive Guidelines §482.13(b)

The hospital must ensure that the exercise of patients’ rights requirements are met.

A-0130

(Rev. 75, Issued: 12-02-11, Effective: 12-02-11, Implementation: 12-02-11)

§482.13(b)(1) The patient has the right to participate in the development and

implementation of his or her plan of care.

Interpretive Guidelines §482.13(b)(1)

This regulation requires the hospital to actively include the patient in the development,

implementation and revision of his/her plan of care. It requires the hospital to plan the

patient’s care, with patient participation, to meet the patient’s psychological and medical

needs.

The patient’s (or patient’s representatives, as allowed by State law) right to participate in

the development and implementation of his or her plan of care includes at a minimum, the

right to: participate in the development and implementation of his/her inpatient

treatment/care plan, outpatient treatment/care plan, participate in the development and

implementation of his/her discharge plan, and participate in the development and

implementation of his/her pain management plan.

Hospitals are expected to take reasonable steps to determine the patient’s wishes concerning

designation of a representative to exercise the patient’s right to participate in the

development and implementation of the patient’s plan of care. Unless prohibited by

applicable State law:

• When a patient who is not incapacitated has designated, either orally to hospital staff

or in writing, another individual to be his/her representative, the hospital must involve

the designated representative in the development and implementation of the patient’s

plan of care. The explicit designation of a representative by the patient takes

precedence over any non-designated relationship and continues throughout the

patient’s inpatient stay or outpatient visit, unless expressly withdrawn, either orally or

in writing, by the patient.

• In the case of a patient who is incapacitated, when an individual presents the hospital

with an advance directive, medical power of attorney or similar document executed by

the patient and designating an individual to make medical decisions for the patient

when incapacitated, the hospital, when presented with the document, must involve the

designated representative in the development and implementation of the patient’s plan

of care. The explicit designation of a representative takes precedence over any non-

designated relationship and continues throughout the patient’s inpatient stay or

outpatient visit, unless the patient ceases to be incapacitated and expressly withdraws

the designation, either orally or in writing.

• When a patient is incapacitated or otherwise unable to communicate his or her wishes,

there is no written advance directive on file or presented, and an individual asserts that

he or she is the patient’s spouse, domestic partner (whether or not formally established

and including a same-sex domestic partner), parent (including someone who has stood

in loco parentis for the patient who is a minor child) or other family member and thus

is the patient’s representative, the hospital is expected to accept this assertion, without

demanding supporting documentation, and must involve the individual as the patient’s

representative in the development and implementation of the patient’s plan of care,