[Federal Register Volume 63, Number 198 (Wednesday, October 14, 1998)]
[Rules and Regulations]
[Pages 55031-55034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27523]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
Centers for Disease Control and Prevention

42 CFR Part 493

[HCFA-2024-FC]
RIN 0938-AI94


Medicare, Medicaid, and CLIA Programs; 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, and May 12, 1997, 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.

[[Page 55032]]

    These effective dates are extended to allow the Department 
additional time to issue revised quality control requirements and to 
determine whether changes are needed in the qualification requirements 
for individuals with doctoral degrees to serve as directors of 
laboratories performing high complexity testing. These effective date 
extensions do not reduce the current requirements for quality test 
performance.

DATES: Effective Date: October 14, 1998.
    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 
December 14, 1998.

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: HCFA-2024-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]. For e-mail comment procedures see 
the beginning of SUPPLEMENTARY INFORMATION. For further information on 
ordering copies of the Federal Register containing this document and on 
electronic access, see the beginning of SUPPLEMENTARY information.

FOR FURTHER INFORMATION CONTACT:
Rhonda S. Whalen (CDC), (770) 488-8155.
Diane Milstead (HCFA), (410) 786-3531.

SUPPLEMENTARY INFORMATION:

E-Mail, Comments, Procedures, Availability of Copies, and 
Electronic Access

    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 HCFA-2024-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., 
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I. Background

    On February 28, 1992, we published in the Federal Register (57 FR 
7002) final regulations with an opportunity for public comment. These 
regulations set 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 of testing 
performed. 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, and on May 12, 1997, we published in the 
Federal Register (59 FR 62606 and 62 FR 25855, respectively) final 
rules with opportunity for comment. These rules 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 May 12, 1997 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 May 12, 1997 
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 July 31, 1998, to December 31, 2000, 
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 July 31, 1998, to December 31, 2000, 
the date for laboratories to meet certain CLIA quality control 
requirements by following manufacturers' FDA CLIA-cleared test system 
instructions.
     We are extending from July 31, 1998, to December 31, 2000, 
the date by which individuals with doctoral degrees must obtain board 
certification to

[[Page 55033]]

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 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 July 31, 1998, 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.
    Section 493.1203, effective beginning July 31, 1998, 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. These resources were not available due to 
financial and other constraints of the program.
    Following the publication of the December 1994 and May 12, 1997 
final rules, we received comments that the current quality control 
requirements are not appropriate for some test methodologies and a 
comprehensive quality control regulation should be developed to address 
``today's'' quality control needs. While a final rule addressing 
quality control issues raised by these commenters is under development, 
it will not be completed by July 31, 1998. Commenters raised issues 
that stressed the need to ensure that the quality control requirements 
are practical and flexible enough to accommodate different testing 
sites and test systems that range from current methodologies to new and 
emerging technologies, so as to not impede access. We must also, as the 
comments suggest, base the requirements on technical considerations as 
well as their impact on patient care.
    To assist us in determining the types of quality control 
requirements necessary to monitor laboratory test performance, we will 
also consider advice provided by the CLIAC, as well as information 
obtained from a public meeting held in September 1996 for manufacturers 
and others to make presentations on quality control.
    Concurrently, the FDA process for product clearance, an integral 
part of the CLIA quality control requirements published in 1992, is 
undergoing comprehensive changes (see Federal Register notices 
published January 21, 1998 (63 FR 3142) and February 2, 1998 (63 FR 
5387)).
    Due to the complexity of the issues that must be addressed, we are 
extending the July 31, 1998, sunset date for quality control standards 
in Sec. 493.1202 to December 31, 2000, and extending the effective date 
for Sec. 493.1203 from July 31, 1998, to December 31, 2000, to allow 
laboratories to continue to meet current regulations until we make 
further determinations regarding these requirements. We are extending 
the effective dates for these sections to December 31, 2000, to ensure 
that we have sufficient time to publish final rules concerning quality 
control. Extending the dates will allow sufficient time for publication 
of final regulations. Subsequent to the publication of the final 
regulations and prior to the actual implementation of the revised 
requirements, we must develop new surveyor guidelines, design new 
survey forms, reprogram the CLIA data system, conduct surveyor 
training, and inform and educate the laboratory community, CLIA exempt 
States and accreditation organizations. Time must be allocated for CLIA 
exempt States and approved accreditation organizations to review their 
requirements and determine whether they must make changes to maintain 
their overall equivalency with the CLIA requirements. CLIA exempt 
States may need to make changes to their State laws. Accreditation 
organizations may also need time to revise policies and requirements 
and have them approved by their organizations for adoption. Our 
implementation delay will provide States and accreditation 
organizations the time needed to make changes to their program 
requirements and for their subsequent review by CDC and HCFA. Failure 
to provide sufficient time for education and implementation could cause 
confusion and interfere with the laboratory community's continued 
compliance with CLIA requirements and jeopardize the continued 
equivalency of CLIA exempt States and accreditation organizations.

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 July 31, 1998. The phase-in 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.
    As stated previously in the preamble to the December 1994 final 
rule, a number of comments to 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 December 31, 2000. 
This extension will allow time for review of the qualifications 
required for laboratory directors to determine whether modifications 
should be made for inclusion in the final rule being developed to 
address other CLIA personnel 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 July 31, 1998, to December 31, 2000.

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.
    The revisions in this final rule are essential, because if the 
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 actively working to revise 
these same quality control requirements. While this activity has begun, 
the issues

[[Page 55034]]

we are addressing are many and complex, particularly in light of 
changing technologies. Since we will be revising the quality control 
requirements in rulemaking that should occur in the reasonably near 
future, to impose more stringent requirements now is unreasonable, 
unnecessary, and confusing. With respect to the personnel standards 
addressed in this rule, if the date is not extended, those individuals 
qualified as laboratory directors under the phase-in requirements based 
on their doctoral degree and laboratory training and work experience 
would no longer qualify to serve as directors of laboratories 
performing high complexity testing. Since we are considering revisions 
to the regulations which would allow individuals with a doctoral degree 
to qualify under alternative provisions that would recognize their 
laboratory training and experience, we would not want to disenfranchise 
these currently employed directors at this time. Extending the dates 
governing laboratory director qualifications will provide the 
opportunity for us to determine whether alternative provisions should 
be developed to qualify individuals with a doctoral degree who have 
laboratory training and experience, but do not have board 
certification. 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. 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.
    Also, because current regulations will expire on the July 31, 1998, 
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 this rule. 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.

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 July 31, 1998, allow adequate time for 
addressing all concerns with respect to revising 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.
    The Unfunded Mandates Reform Act of 1995 also requires (in section 
202) that agencies prepare an assessment of anticipated costs and 
benefits for any rule that may result in annual expenditures by State, 
local, or tribal governments, in the aggregate, or by the private 
sector, of $100 million. The final rule has no consequential effect on 
State, local, or tribal governments. We believe the private sector 
costs of this rule fall below these thresholds, as well.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

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, part 493 is amended as set forth below:

PART 493--LABORATORY REQUIREMENTS

    1. The authority citation for part 493 continues 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 ``July 31, 
1998.'' and add in its place ``December 31, 2000.''.


Sec. 493.1203  [Amended]

    3. In Sec. 493.1203, in the section heading, remove ``July 31, 
1998.'' and add in its place ``December 31, 2000.''.


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 ``July 31, 
1998,'' and add in its place ``December 31, 2000,''.
    b. In Sec. 493.1443(b)(3)(ii)(C), remove ``July 31, 1998,'' and add 
in its place ``December 31, 2000,''.

(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: May 20, 1998.
Claire V. Broome,
Acting Director, Centers for Disease Control and Prevention.

    Dated: May 20, 1998.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.

    Dated: August 5, 1998.
Donna E. Shalala,
Secretary.
[FR Doc. 98-27523 Filed 10-13-98; 8:45 am]
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BILLING CODE 4160-18-P