[Federal Register Volume 62, Number 91 (Monday, May 12, 1997)]
[Rules and Regulations]
[Pages 25855-25858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12271]


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