Medicare, Medicaid, and CLIA Programs; Clinical Laboratory RequirementsExtension of Certain Effective Dates for Clinical Laboratory Requirements Under CLIA

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

Centers for Disease Control and Prevention

42 CFR Part 493

[HSQ-237-FC]

RIN 0938-AH84

Medicare, Medicaid, and CLIA Programs; Clinical Laboratory

Requirements--Extension of Certain Effective Dates for Clinical

Laboratory Requirements Under CLIA

AGENCY: Centers for Disease Control and Prevention (CDC) and Health

Care Financing Administration (HCFA), HHS.

ACTION: Final rule with comment period.

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SUMMARY: This final rule extends certain effective dates for clinical

laboratory requirements in regulations published on February 28, 1992,

and subsequently revised December 6, 1994, that implemented provisions

of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This

rule extends the phase-in date of the quality control requirements

applicable to moderate and high complexity tests and extends the date

by which an individual with a doctoral degree must possess board

certification to qualify as a director of a laboratory that performs

high complexity testing.

These effective dates are extended to allow the Department

additional time to issue revised quality control requirements and to

ensure laboratory directors are able to complete certification

requirements. These effective date extensions do not reduce

[[Page 25856]]

the current requirements for quality test performance.

DATES: These regulations are effective on May 12, 1997.

Comment date: Comments will be considered if we receive them at the

appropriate address, as provided below, no later than 5:00 p.m. on July

11, 1997.

ADDRESSES: Mail written comments (1 original and 3 copies) to the

following address: Centers for Disease Control and Prevention,

Department of Health and Human Services, Attention: HSQ-237-FC, 4770

Buford Hwy., NE., MS F11, Atlanta, Georgia 30341-3724.

If you prefer, you may deliver your written comments (1 original

and 3 copies) to the following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,

Washington, DC 20201, or

Room C5-09-26, Central Building, 7500 Security Boulevard, Baltimore, MD

21244-1850.

Comments may also be submitted electronically to the following e-

mail address: [email protected] E-mail comments must include the full

name and address of the sender. All comments must be incorporated in

the e-mail message because we may not be able to access attachments.

Electronically submitted comments will be available for public

inspection at the Independence Avenue address below.

Because of staffing and resource limitations, we cannot accept

comments by facsimile (FAX) transmission. In commenting, please refer

to file code HSQ-237-FC. Written comments received timely will be

available for public inspection as they are received, generally

beginning approximately 3 weeks after publication of a document, in

Room 309-G of the Department's offices at 200 Independence Avenue, SW.,

Washington, DC, on Monday through Friday of each week from 8:30 a.m. to

5:00 p.m. (phone: (202) 690-7890).

Copies: To order copies of the Federal Register containing this

document, send your request to: New Orders, Superintendent of

Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date

of the issue requested and enclose a check or money order payable to

the Superintendent of Documents, or enclose your Visa or Master Card

number and expiration date. Credit card orders can also be placed by

calling the order desk at (202) 512-7800 (or toll free at 1-888-293-

6498) or by faxing to (202) 512-2250. The cost for each copy is $8.00.

As an alternative, you can view and photocopy the Federal Register

document at most libraries designated as Federal Depository Libraries

and at many other public and academic libraries throughout the country

that receive the Federal Register.

This Federal Register document is also available from the Federal

Register online database through GPO Access, a service of the U.S.

Government Printing Office. Free public access is available on a Wide

Area Information Server (WAIS) through the Internet and via

asynchronous dial-in. Internet users can access the database by using

the World Wide Web; the Superintendent of Documents home page address

is http://www.access.gpo.gov/su__docs/, by using local WAIS client

software, or by telnet to swais.access.gpo.gov, then log in as guest

(no password required). Dial-in users should use communications

software and modem to call (202) 512-1661; type swais, then log in as

guest (no password required).

FOR FURTHER INFORMATION CONTACT: Rhonda S. Whalen (CDC), (770) 488-

7655.

SUPPLEMENTARY INFORMATION:

I. Background

On February 28, 1992, we published final regulations with an

opportunity for public comment in the Federal Register, at 57 FR 7002,

setting forth the requirements for laboratories that are subject to the

Clinical Laboratory Improvement Amendments of 1988 (CLIA). These

regulations established uniform requirements for all laboratories

regardless of location, size, or type. In developing the regulations,

we included requirements that would ensure the quality of laboratory

services and be in the best interest of the public health. We

recognized that a rule of this scope required time for laboratories to

understand and to implement the new requirements. Therefore, certain

requirements were phased-in and given prospective effective dates. We

also planned to address the comments we received on the February 28,

1992 rule and make modifications, if necessary, in a subsequent final

rule.

On December 6, 1994, we published a final rule with opportunity for

comment in the Federal Register at 59 FR 62606. This revision to the

February 28, 1992 final rule included provisions that extended the

phase-in of the quality control requirements applicable to moderate and

high complexity tests and the date by which an individual with a

doctoral degree must possess board certification to qualify as a

director of a laboratory that performs high complexity testing. These

changes were made due to the resource constraints that had prevented

the Department of Health and Human Services from establishing the

process to review manufacturers' test system quality control

instructions for CLIA compliance and the inability of many laboratory

directors to complete certification requirements within the time period

originally specified.

II. Revisions to the Regulations

The date extensions provided by the December 6, 1994 rule have

proven to be inadequate for the reasons set forth below. In addition,

based on our evaluation of comments submitted in response to the

December 6, 1994 rule and on advice from the Clinical Laboratory

Improvement Advisory Committee (CLIAC) concerning the quality control

requirements appropriate to ensure quality testing and the

qualification requirements for laboratory directors, we have found it

necessary to make the following revisions to our regulations:

We are extending from September 1, 1996 to July 31, 1998

the current phase-in quality control requirements for moderate and high

complexity tests. The phase-in quality control requirements for

unmodified, moderate complexity tests cleared by the Food and Drug

Administration (FDA) (through 510(k) or premarket approval processes,

unrelated to CLIA), are less stringent than the requirements applicable

to high complexity and other moderate complexity tests.

We are extending from September 1, 1996 to July 31, 1998

the date for laboratories to meet certain CLIA quality control

requirements by following manufacturers' FDA CLIA-cleared test system

instructions.

We are extending from September 1, 1996 to July 31, 1998

the date by which individuals with doctoral degrees must obtain board

certification to qualify as director of a laboratory that performs high

complexity tests.

These revisions are discussed in more detail below.

A. Quality Control Requirements

42 CFR Sec. 493.1202 contains the quality control requirements

applicable to moderate and high complexity tests and allows a

laboratory that performs tests of moderate complexity, using test

systems cleared by the FDA through the section 510(k) or premarket

approval processes, until September 1, 1996 to comply with the quality

control provisions of part 493 subpart K by meeting less stringent

quality control requirements, as long as the laboratory has not

modified the instrument, kit, or test system's procedure.

[[Page 25857]]

Section 493.1203, effective beginning September 1, 1996,

establishes a mechanism for laboratories using commercial, unmodified

tests to fulfill certain quality control requirements by following

manufacturers' test system instructions that have been reviewed and

determined by the FDA to meet applicable CLIA quality control

requirements. Implementation of this review process, however, depended

upon the availability of sufficient additional resources necessary to

meet the projected workload.

Comments received on the February 1992 final rule expressed

opposition to the quality control phase-in provision. Following the

publication of the December 1994 final rule, we received additional

comments indicating continued concerns about the quality control phase-

in. A final rule addressing quality control issues raised by commenters

on the February 1992 and December 6, 1994 rules is still under

development. Therefore, we are extending the September 1, 1996 sunset

date for quality control standards in Sec. 493.1202 to July 31, 1998

and extending the effective date for Sec. 493.1203 from September 1,

1996 to July 31, 1998 to allow laboratories to continue to meet current

regulations until we make further determinations regarding these

requirements. To assist us in determining the types of quality control

requirements necessary to monitor laboratory test performance, we have

solicited advice from the CLIAC and, in addition, we held a two-day

public meeting in September 1996 for manufacturers and others to make

presentations on quality control.

We recognize that these revisions may have substantive implications

for those laboratories performing only unmodified, moderate complexity

testing previously cleared through the FDA's section 510(k) or

premarket approval processes. We are, therefore, maintaining the

provisions for these tests, as listed in Sec. 493.1202(c), until July

31, 1998. We expect to revise the existing quality control regulations

by this date.

B. Laboratory Director Qualifications

Section 493.1443(b)(3) provides that a director of a laboratory

performing high complexity testing, who has an earned doctoral degree

in chemical, physical, biological, or clinical laboratory science from

an accredited institution, must be certified by a board recognized by

the Department as of September 1, 1996. The phase-in, revised from 2 to

4 years, was designed to allow the Department adequate time to review

requests for approval of certification programs and to ensure that a

laboratory director with a doctoral degree had sufficient time to

successfully complete the requirements for board certification.

In 1992, we expected that an adequate number of certification

boards would apply and be approved. On that basis, we required board

certification by September 1, 1994. This date was extended to September

1, 1996 due to much slower progress than anticipated. While the

Department has announced the approval of two additional certification

boards in a Federal Register notice published July 8, 1996, at 61 FR

35762, additional requests for board approval are currently under

review. We believe a further extension of the September 1, 1996 date is

in order.

As stated previously in the preamble to the December 1994 final

rule, a number of commenters on the February 1992 final rule suggested

that board certification not be a mandatory requirement for currently

employed individuals. In addition, CLIAC has suggested, and we are

still considering, the development of alternative provisions to qualify

currently employed individuals with a doctoral degree on the basis of

laboratory training or experience, in lieu of requiring board

certification.

We are extending the date by which an individual with a doctoral

degree must possess board certification to qualify as a director of a

laboratory that performs high complexity testing to July 31, 1998. This

extension will allow time for the approval of additional boards, and to

remove the inadvertent disqualification of doctoral-degreed individuals

with laboratory training and experience as high complexity laboratory

directors. Between the present time and the July 1998 date, we will

review the qualifications required for laboratory directors to ensure

that they are appropriate and determine whether modifications should be

made for inclusion in the final rule being developed to address other

CLIA issues raised by commenters on the February 1992 final rule.

In summary, we are extending the phase-in period in

Sec. 493.1443(b)(3) from September 1, 1996 to July 31, 1998.

III. Waiver of Proposed Rulemaking and Delayed Effective Date

We ordinarily publish a notice of proposed rulemaking in the

Federal Register and invite public comment on proposed rules. The

notice of proposed rulemaking includes a reference to the legal

authority under which the rule is proposed, and the terms and substance

of the proposed rule or a description of the subjects and issues

involved. This procedure can be waived, however, if an agency finds

good cause that a notice-and-comment procedure is impracticable,

unnecessary, or contrary to the public interest and incorporates a

statement of the finding and its reasons in the rule issued.

These revisions are essential, because if these dates for quality

control requirements are not extended, many laboratories performing

moderate complexity testing will be faced unnecessarily with meeting

more stringent and burdensome quality control requirements at a time

when we are considering revisions to these same quality control

requirements. Since we plan to publish revised quality control

requirements in future rulemaking, to impose more stringent

requirements when these regulations are currently under review is

unreasonable. With respect to the personnel standards addressed in this

rule, if the date for board certification of individuals with doctoral

degrees is not extended, those individuals qualified as laboratory

directors through their doctoral degree and certification by a board

currently under review by us could be disenfranchised until they have

an opportunity to be certified by an approved board. Although these

directors have shown competency through certification by a professional

board, we have not yet completed our review of all boards that have

applied. Extending the date under these regulations governing

laboratory director requirements will provide the opportunity for

completion of these reviews without forcing the removal of individuals

who have already shown their ability to fulfill the tasks we ask of

laboratory directors. Accordingly, we believe that it is impracticable,

unnecessary, and not in the public interest to engage in proposed

rulemaking and believe there is good cause for doing so and to issue

this final rule with a 60-day comment period. Also, because the

September 1, 1996 date has caused these regulations to expire,

additional urgency has been placed on the implementation of this rule.

We, therefore, believe there is good cause to waive a delay in the

effective date of these rules. To do otherwise would create unnecessary

confusion among laboratories in understanding the requirements they

must meet with respect to quality control and laboratory director

qualifications. It could also impose unnecessary burdens on

laboratories and hardships on individuals affected by these

requirements.

[[Page 25858]]

IV. Regulatory Impact Statement

Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601

through 612), we prepare a regulatory flexibility analysis unless we

certify that a rule will not have a significant economic impact on a

substantial number of small entities. For purposes of the RFA, all

laboratories are considered to be small entities. Individuals and

states are not included in the definition of a small entity.

In addition, section 1102(b) of the Act requires us to prepare a

regulatory impact analysis if a rule may have a significant impact on

the operations of a substantial number of small rural hospitals. That

analysis must conform to the provisions of section 604 of the RFA. For

purposes of section 1102(b) of the Act, we define a small rural

hospital as a hospital that is located outside of a Metropolitan

Statistical Area and has fewer than 50 beds.

Extending the phase-in periods will continue the quality control

requirements in effect prior to September 1, 1996, allow additional

time to make further determinations regarding revision to the quality

control requirements, and not change costs, savings, burden, or

opportunities to manufacturers, laboratories, individuals administering

tests, or patients receiving the tests.

For these reasons, we have determined, and the Secretary certifies,

that this regulation does not result in a significant impact on a

substantial number of small entities and does not have a significant

effect on the operations of a substantial number of small rural

hospitals. Therefore, we are not preparing analyses for either the RFA

or section 1102(b) of the Act because we have determined, and we

certify, that this rule will not have a significant economic impact on

a substantial number of small entities or a significant impact on the

operations of a substantial number of small rural hospitals.

In accordance with the provisions of Executive Order 12866, this

regulation was reviewed by the Office of Management and Budget.

V. Response to Comments

Because of the large number of items of correspondence we normally

receive on Federal Register documents published for comment, we are not

able to acknowledge or respond to them individually. However, we will

consider all comments we receive on the date extensions described in

this rule by the date and time specified in the ADDRESSES section of

this preamble, and, if we proceed with a subsequent document, we will

respond to the comments in the preamble to that document.

List of Subjects in 42 CFR Part 493

Grant programs--health, Health facilities, Laboratories, Medicaid,

Medicare, Reporting and recordkeeping requirements.

42 CFR chapter IV is amended as follows:

PART 493--LABORATORY REQUIREMENTS

1. The authority citation for part 493 is revised to read as

follows:

Authority: Sec. 353 of the Public Health Service Act, secs.

1102, 1861(e), and the sentence following sections 1861(s)(11)

through 1861(s)(16) of the Social Security Act (42 U.S.C. 263a,

1302, 1395x(e), and the sentence following 1395x(s)(11) through

1395x(s)(16)).

Sec. 493.1202 [Amended]

2. In Sec. 493.1202, in the section heading, remove ``September 1,

1996.'' and add in its place ``July 31, 1998.''.

Sec. 493.1203 [Amended]

3. In Sec. 493.1203, in the section heading, remove ``September 1,

1996.'' and add in its place ``July 31, 1998.''.

Sec. 493.1443 [Amended]

4. Section 493.1443 is amended as set forth below:

a. In Sec. 493.1443(b)(3)(ii) introductory text, remove ``September

1, 1996,'' and add in its place ``July 31, 1998,''.

b. In Sec. 493.1443(b)(3)(ii)(C), remove ``September 1, 1996,'' and

add in its place ``July 31, 1998,''.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical

Assistance Program; Catalog of Federal Domestic Assistance Program

No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774,

Medicare--Supplementary Medical Insurance Program)

Dated: December 17, 1996.

David Satcher,

Director, Centers for Disease Control and Prevention.

Dated: December 20, 1996.

Bruce C. Vladeck,

Administrator, Health Care Financing Administration.

Dated: January 28, 1997.

Donna E. Shalala,

Secretary.

[FR Doc. 97-12271 Filed 5-9-97; 8:45 am]

BILLING CODE 4120-01-P