Clinical Laboratory Improvement Amendments of 1988 Waiver

Clinical Laboratory Improvement Amendments of 1988

Waiver History

October 1988 – October 2014

Date

Description of Federal Register Publication or Historical Event

10/31/88

Clinical Laboratory Improvement Amendments (CLIA) of 1988 was enacted.

Waived tests were defined as simple laboratory examinations and

procedures

which, as

determined by the Secretary, have an

insignificant

risk of an

erroneous

result, including those

which--

(1)

have been approved by the Food and Drug Administration (FDA) for home use;

(2) employ methodologies that are so simple and accurate as to render

the

ikelihood of erroneous results negligible

;

(3) the Secretary has determined pose no reasonable risk of harm to the patient if

the test is performed incorrectly.

In addition, the law specified that waived tests are exempt from the CLIA health and safety

standards, including personnel, patient test management, quality control, proficiency testing,

quality assurance and routine inspections requirements.

2/28/92

Regulations (final rule with comment) were published listing eight types of tests or

examinations that met

the

statutory waiver criteria:

(1) dipstick or tablet reagent urinalysis (non-automated) for

bilirubin,

glucose, hemoglobin,

ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen;

(2) fecal occult

blood;

(3) ovulation tests--visual color comparison tests for human luteinizing hormone;

(4) urine pregnancy tests--visual color comparison

tests;

(5) erythrocyte sedimentation

rate--non-automated;

(6) hemoglobin--copper sulfate--non-automated;

(7) blood glucose by glucose monitoring devices cleared by the FDA specifically for home

use; and

(8) spun microhematocrit.

1/19/93

A final rule was published adding to the list of waived tests: hemoglobin by single analyte

instruments with self-contained or component features to perform specimen/reagent

interaction, providing direct measurement and

readout.

2/18/93

Approximately 1,100 of the comments received to the 2/28/92 regulations concerned the

determination of waived test status, specifically the subjectiveness of the criteria for waiver and

the failure of tests to be granted waiver. The Centers for Disease Control and Prevention (CDC)

sought advice from the CLIAC and on 2/17-18/93. CLIAC recommended that CDC clarify the

criteria and process for waiver and establish a moratorium on considering tests for waiver

approval until the criteria were better defined. CDC established the moratorium, as

recommended, while developing guidelines and a proposed rule to revise the CLIA requirements

for waiver approvals. CDC used the determination of "simple" and "not prone to error" as a

mechanism to meet the statutory requirement that waived tests "have an

insignificant

risk of an

erroneous result" and required waived testing to be capable of performing accurately under all

testing conditions and in all test settings.

12/19/94

The waiver moratorium was lifted, and an interim waiver review process was established by

CDC. CDC notified manufacturers of moderate complexity test systems that it would consider

any moderate complexity test system that met the statutory waiver criteria and for which

the

manufacturer or producer applied for waiver in accordance with the draft guidelines

containing waiver criteria a process for reviewing waiver requests.

9/13/95

A proposed rule was published

clarifying

the

statutory

criteria for determining which tests

could be waived and to provide for automatic

waiver of FDA-

approved home use tests. The

rule also proposed that all previously waived tests be reevaluated using the clarifications to the

waiver criteria in the regulation.

11/21/97

Congress enacted the Food and Drug Administration Modernization Act of

1997 (FDAMA)

revising the CLIA law to make it clear that tests approved by the FDA for home

use

automatically qualify for CLIA waiver. In addition, Congress added "by the

user"

to the

waiver provision related to

simplicity

and accuracy of methodologies, i.e., "employ

methodologies that are so simple and accurate as to render the likelihood of erroneous results

by the user negligible." (emphasis added). The waiver section of the CLIA statute now

reads: Waived tests "are laboratory examinations and procedures that have been approved by

the Food and Drug Administration for home use or that,

determined by the Secretary, are

simple laboratory examinations and procedures that have an insignificant risk of an erroneous

result, including those

that-

(A) employ methodologies that are so simple and accurate as to render the

likelihood of erroneous results by the user

negligible,

(B) the Secretary has determined pose no unreasonable risk of harm to the patient if

performed

incorrectly."

According to the legislative history from House Report 105-310 to associated bill H.R. 1411

under section 21, "Modernization of regulation," the intent of the "by the user"

clarifying

language was to focus the waiver criteria on

verifying

test

performance by the user and

eliminating

the potential for operator error in performing the test. The history also stated that,

without this clarification, interpretations

of "erroneous

result" and "accurate" could include the

inherent

clinical

sensitivity and specificity of a test system, which would be inappropriate since

those parameters were under the purview of the FDA. The history concluded by stating that

this change was intended only to

specify

the focus of

the

criterion and

not meant in any way to

change the acceptable level of user

error."

5/12/98

A citizen petition was filed by the Partners for Public Health and Government requesting

CDC and the Health Care Financing Administration (HCFA) – now the Centers for

Medicare and Medicaid Services (CMS) - to enter into negotiated rulemaking to develop

waiver regulations.

2/27/99

An interagency agreement was signed by CDC, HCFA, and FDA, transferring

the

responsibility

for categorizing the complexity of commercially marketed laboratory tests and evaluating requests

for waiver from CDC to FDA.

12/30/99

A Federal Register notice announced the transfer of responsibility for the categorization

(including waiver determinations) of commercially marketed in vitro diagnostic (IVD) tests under

CLIA’88 from CDC to the FDA. The transfer of test categorization was completed January 2000

and the transfer of the

responsibility

for waiver determinations was completed February 2000.

8/14-15/00

FDA held a

public

workshop to obtain comments on the criteria and process used to determine

whether a test could be waived. Presentations

were

made by 29

individuals

representing

government, industry, professional

laboratory

organizations, and academic institutions and some

provided written comments.

1/23/01

FDA posted draft guidance for waiver, "Guidance for

Clinical

Laboratory Improvement

Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and

FDA," on

its website and sent a copy

to CDC for distribution at the upcoming CLIAC meeting.

09/07/05

FDA published a notice announcing the availability of the updated draft guidance entitled

“Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver

Applications” to recommend an approach for submission of waiver applications by

manufacturers. This draft guidance replaced the previous draft guidance entitled “Guidance for

Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver.”

01/30/08

FDA published a notice announcing the availability of the final guidance entitled

“Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver

Applications for Manufacturers of In Vitro Diagnostic Devices.” The guidance described

recommendations for device manufacturers seeking to submit applications to FDA for waiver

approval.