[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).
Copies: To order copies of the Federal Register containing this
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As an alternative, you can view and photocopy the Federal Register
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This Federal Register document is also available from the Federal
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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]
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