[Federal Register: December 6, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
Public Health Service
42 CFR Part 493
[HSQ-217-FC]
RIN 0938-AG86
Medicare, Medicaid and CLIA Programs; Extension of Certain
Effective Dates for Clinical Laboratory Requirements and Personnel
Requirements for Cytologists
AGENCY: Health Care Financing Administration (HCFA) and Public Health
Service (PHS), 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,
which implemented provisions of the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) and announces our approval of a certifying
organization for qualifying cytotechnologists. This rule extends the
date by which an individual must enroll in an HCFA-approved cytology
proficiency testing (PT) program 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. In
addition, we are extending the phase-in of the quality control
requirements applicable to unmodified, moderate complexity tests
cleared for commercial distribution by the Food and Drug Administration
(FDA). We are extending the date to meet applicable CLIA QC
requirements for laboratories using commercial, nonmodified tests to
fulfill certain quality control (QC) requirements.
These effective date extensions do not reduce the current
requirements for quality test performance. The date extensions are
necessary due to the limited number and scope of currently operating
cytology PT programs, resource constraints that have prevented
commencement of the substantial number of quality control reviews, and
inability of many laboratory directors to complete certification
requirements within the time period originally specified.
DATES: These regulations are effective on December 6, 1994. Comments
will be considered if we receive them at the appropriate address, as
provided below, no later than 5 p.m. on February 6, 1996.
ADDRESSES: Mail written comments (1 original and 3 copies) to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: HSQ-217-FC, P.O. Box 26676,
Baltimore, MD 21207.
If you prefer, you may deliver your written comments (1 original
and 3 copies) to one of the following addresses: Room 309-G, Hubert H.
Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201,
or Room 132, East High Rise Building, 6325 Security Boulevard,
Baltimore, MD 21207.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code HSQ-217-FC. 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 p.m.
(phone: (202) 690-7890).
FOR FURTHER INFORMATION CONTACT: Josephine A. Simmons (410) 597-5882.
SUPPLEMENTARY INFORMATION:
I. Background
On February 28, 1992, we published in the Federal Register at 57 FR
7002, final regulations with an opportunity for public comment that set
forth requirements for laboratories that are subject to 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
service 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 comments on the February 28 rule and make modifications, if
necessary, in a successor final rule.
On January 6, 1994, we published a final regulation in the Federal
Register, at 59 FR 682. This revision to the February 28, 1992 rule
extended the time for individuals to meet the educational
qualifications for a cytotechnologist by either completing a training
program or being certified by an approved organization. These changes
were made to prevent the loss of qualified personnel in the field of
cytotechnology and to allow the Department the time necessary to
recognize organizations that certify cytology personnel.
In the February 28, 1992 regulations, there are three prospectively
set dates that need extensions to prevent disruption in implementation
of the CLIA requirements. At Sec. 493.855, Standard; Cytology:
Gynecologic examinations, we required the laboratory, by January 1,
1994, to enroll each individual engaged in the examination of
gynecologic preparations in a PT program approved by HCFA. At
Sec. 493.1202, Standard; Moderate or high complexity testing, or both:
Effective from September 1, 1992, to September 1, 1994, we established
quality control (QC) requirements for high complexity or moderate
complexity tests including less stringent requirements for unmodified,
moderate complexity testing cleared for commercial distribution by the
FDA. At Sec. 493.1203, Standard; Moderate or high complexity testing,
or both: Effective beginning September 1, 1994, we established a
mechanism for laboratories using commercial, non-modified tests to
fulfill certain QC requirements by following manufacturer's
instructions that have been reviewed and determined by the FDA to meet
applicable CLIA QC requirements. At Sec. 493.1443, Standard; Laboratory
director qualifications, until September 1, 1994, an individual holding
a doctoral degree may qualify with either (1) board certification, or
(2) two years of laboratory training or experience, or both, and two
years of experience directing or supervising high complexity testing.
After September 1, 1994, all individuals qualifying with a doctoral
degree must have board certification.
For each of these requirements, we allowed what we considered as
adequate time for laboratories to enroll personnel in a HCFA-approved
cytology PT program, for manufacturers to obtain a QC review from the
FDA, and for individuals to obtain certifications, given our planned
publication date of the final regulations. However, approximately
16,000 comments were received on the February 28 rule, which required
reevaluation of numerous provisions.
As of January 1994, no cytology PT program had met the requirements
for HCFA approval, we have not yet been able to implement the FDA
review of QC instructions, and we do not anticipate that a final rule
will be issued prior to the September 1994 date affecting the board
certification requirement for an individual with a doctoral degree to
qualify as a laboratory director. Therefore, we need to extend these
prospectively set dates to allow time for laboratories and individuals
to meet the CLIA requirements.
In the regulations published on February 28, 1992, we established a
pathway at Sec. 493.1483 that allows an individual to qualify as a
cytotechnologist if she or he is certified in cytotechnology by an HHS-
approved agency. In the preamble to this rule, we are announcing HHS
approval of an agency to certify cytotechnologists.
In this rule we also address the comments we received in response
to two major areas: Effective dates for implementation of the
requirements mentioned above and approval of an agency to certify
cytotechnologists. The comments on implementation effective dates
focused on the need for phase-in periods, feasibility of achieving
compliance with the requirements by the end of the phase-in periods,
and alternatives to the phase-in periods. The comments on the cytology
qualification requirements included recommendations that HHS approve an
agency that certifies cytotechnologists.
II. Responses to Comments
A. Proficiency Testing of Individuals Who Examine Gynecological
Preparations (Sec. 493.855)
Section 493.855 requires that a laboratory ensure that, as of
January 1, 1994, each individual performing gynecologic cytology
services is enrolled in a gynecologic cytology PT program approved by
HCFA. A Request for Proposal was issued for a contractor to undertake
procurement of glass slides necessary to operate the cytology PT
program nationally. We received no responses. However, we did receive
comments from the cytology societies and individuals indicating that
the program was logistically and financially unworkable. The Centers
for Disease Control and Prevention (CDC) cosponsored a cytology
symposium in November 1993 to establish possible alternatives to
providing a cytology PT program. In December 1993, the Clinical
Laboratory Improvement Advisory Committee (CLIAC) established under
Sec. 493.2001 of our regulations recommended that legislative and
regulatory changes be pursued to provide for an alternative program for
cytology PT, including encouraging private or State-administered
programs to meet current regulations. To date, only two cytology PT
programs have applied for HCFA approval. The two programs are State-
operated and enrollment capacity is limited.
Comment: One group of commenters believed that the PT requirements,
as currently written, are impossible to implement. The commenters noted
the limited availability of PT programs and believed that the timeframe
for implementing cytology PT is unrealistic.
Response: We understand the commenters' concerns. Although a State
program has been approved for calendar year 1995, it has not been
possible to implement a national program within the timeframe specified
in the regulations. Therefore, in this final rule, we are changing the
effective date for individuals to enroll and participate in a HCFA-
approved cytology PT program from January 1, 1994 to January 1, 1995.
Enrollment by this date is required if an approved program is available
in the State in which the individual is employed.
For individuals engaged in the examination of gynecologic
preparations who are employed in a State in which an approved cytology
PT program is available, cytology PT enrollment and participation is
required beginning January 1, 1995. For individuals engaged in the
examination of gynecologic preparations who are employed in a State in
which a HCFA-approved cytology PT program is not available beginning
January 1, 1995, enrollment and participation in cytology PT is
required when a HCFA-approved program becomes available. We recognize
that additional time is needed for development and approval of cytology
PT programs that will apply nationwide. Presently, the major impediment
in making cytology PT available on a national basis is the difficulty
in obtaining a sufficient number of properly referenced glass slides.
It has been suggested, and we agree, that programs using facsimiles of
glass slides (for example, transparencies, computer images, etc.)
should be considered for PT purposes. We plan to revise the regulations
to allow approval of programs that employ testing media other than
glass slides. The CDC is undertaking studies to evaluate alternative
cytology PT programs. If alternative programs are feasible, we will
ensure that such programs are comparable to glass side programs.
Implementation of PT using alternative media will be phased-in to
familiarize cytology personnel and evaluate the programs. During the
phase-in, we will ensure that individuals are not penalized due to
performance in an alternative program. We believe that this approach
will meet the statutory mandate that PT be available nationwide to
evaluate the performance of all cytology personnel.
B. Quality Control Requirements for Unmodified, Moderately Complex
Tests (Secs. 493.1202 and 493.1203)
Sections 493.1202 and 493.1203 provide for a 2-year phase-in period
during which manufacturers could submit QC instructions relevant to
their products to FDA for review and clearance. Under the regulations,
laboratories would be in compliance with the QC provisions of part 493
subpart K by meeting less stringent QC requirements and following the
manufacturer's instructions, as long as the laboratory has not modified
the instrument, kit, or test system's procedure.
Comment: Of the approximately 16,000 letters of comment received in
response to the February 28, 1992 regulations, nearly 300 were in
reference to the general QC requirements of subpart K. Over 25 percent
of these commenters were opposed to allowing a laboratory to meet the
CLIA QC requirements by following the manufacturer's FDA-cleared QC
instructions. The majority of commenters indicated that all
laboratories should be subject to the same QC requirements. Less than
two percent of the commenters agreed with the provision. Approximately
two percent of the commenters expressed concern that a laboratory may
be penalized if the FDA does not complete the assessment of a
manufacturer's QC instructions prior to the end of the phase-in period.
Response: We acknowledge the commenters' concerns. Having
encountered difficulties in commencing the review of manufacturers' QC
instructions, we are extending the effective date of Sec. 493.1203,
which contains the quality control requirements for moderate or high
complexity testing, or both, from September 1, 1994 to September 1,
1996. In addition, we are extending the September 1, 1994 sunset date
until September 1, 1996 of Sec. 493.1202, which contains the quality
control standards for moderate or high complexity testing, or both.
C. Board Certification of a Laboratory Director With Doctoral Degree
(Sec. 493.1443(b)(3))
Section 493.1443(b)(3) provides that a director of a laboratory
performing high complexity testing who has an earned doctoral degree in
a chemical, physical, biological or clinical laboratory science from an
accredited institution must, as of September 1, 1994, be certified by a
board recognized by HHS. The 2-year phase-in was designed to allow HHS
additional 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.
A number of commenters on the final rule suggested that board
certification not be a mandatory requirement for currently employed
individuals. In addition, CLIAC has suggested, and we are considering,
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. Furthermore,
in at least one specialty, there is currently no board certification,
but a program is being developed.
Comment: One commenter suggested that doctoral degree training and
education were sufficient without requiring board certification to
qualify as a laboratory director. One commenter agreed with requiring
board certification.
Response: In reply to these comments and to the recommendations of
CLIAC, we are allowing additional time to review the qualifications
required to ensure that they are appropriate. We are extending the
phase-in period in Sec. 493.1443 from September 1, 1994, to September
1, 1996 to allow additional time for this evaluation.
Comment: One commenter suggested that the director be board
certified in the specialty of testing that the laboratory performs.
Response: We recognize that, at this time, not all specialties have
board certification programs. In at least one specialty, certification
programs are being developed. To allow additional time for boards to
request HHS approval, for us to review the requirements for
appropriateness, and to ensure that laboratory directors can continue
to meet the requirements as boards apply, we are extending the time
period in Sec. 493.1443 from September 1, 1994, to September 1, 1996.
D. Agency Approved by HHS To Certify Cytotechnologists
(Sec. 493.1483(b)(2))
In the personnel requirements in Sec. 493.1483(b)(2), an individual
may qualify as a cytotechnologist if he or she is certified in
cytotechnology by a certifying agency approved by HHS. In response to
the regulations published February 28, 1992, numerous commenters
suggested that the American Society of Clinical Pathologists (ASCP) be
recognized by the Department since it is a national certifying agency
for cytotechnologists in the United States. The ASCP applied for
approval and provided materials in support of its request for
recognition as a cytotechnologist certifying agency. The qualifications
used by ASCP to qualify an individual as a cytotechnologist include
both educational and training components that are similar to, or more
stringent than, the current CLIA requirements for cytotechnologists. In
addition, ASCP requires successful completion of a competency
examination to measure skills in cytology. Since the ASCP's
requirements for certifying individuals in cytotechnology meet the CLIA
requirements, we are announcing that, effective on the date of
publication of this rule, we have approved the ASCP as a certifying
agency for cytotechnologists. Cytotechnologists certified by ASCP now
meet the CLIA cytotechnologists personnel qualification requirements.
III. Waiver of Delayed Effective Date
As required by the Administrative Procedure Act, we generally
provide for final rules to be effective 30 days after the date of
publication unless we find good cause to waive the delay. We believe
that these revisions are essential to the effective implementation of
the CLIA program and should be implemented immediately. Delaying the
effective date of this regulation would potentially disrupt public
access to laboratory services and create unnecessary confusion among
laboratories in understanding the standards they must meet.
Accordingly, we find good cause to waive the delayed effective date as
contrary to the public interest.
IV. Regulatory Impact Statement
We generally prepare a regulatory flexibility analysis that is
consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612) unless the Secretary certifies that a final 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.
Also, section 1102(b) of the Act requires the Secretary to prepare
a regulatory impact analysis if a final rule may have a significant
impact on the operations of a substantial number of small rural
hospitals. This 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.
This final rule extends the date by which an individual must enroll
in an approved cytology proficiency testing program, the date by which
an individual with a doctoral degree must obtain board certification to
qualify as a director of a laboratory that performs high complexity
testing, and the expiration date of the phase-in for quality control
requirements for unmodified, moderate complexity testing cleared
through the FDA 510(k) or PMA processes. Because controlling components
of the regulations (for example, approved PT programs and approved
board certification programs) are not yet fully in place, compliance
with these existing regulations is unachievable for most laboratories
and their personnel. Extending the phase-in periods will result in
continuation of previously published requirements and will not result
in changed costs, savings, burden or opportunities to manufacturers,
laboratories, individuals administering tests, or patients receiving
them.
This rule also announces the approval of ASCP as a certifying
agency for cytotechnologists. The February 28, 1992 regulation added
certification by an approved certifying agency as an optional method of
qualifying as a cytotechnologist. The majority of those who commented
on the cytotechnologist qualification requirements specified in the
February 28, 1992 rule identified certification by ASCP as the
preferred alternative method of qualifying and recommended that ASCP be
approved by HHS as a certifying agency. The ASCP's certification
requirements have been shown to meet or exceed CLIA requirements;
therefore, the announcement of ASCP's approval should be well received
by all affected entities.
We are not preparing an analysis for either the RFA or section
1102(b) of the Act since we have determined, and the Secretary
certifies, that this final rule will not result in a significant
economic impact on a substantial number of small entities and will not
have 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.
IV. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).
Lists of Subjects in 42 CFR Part 493
Grant programs--health, Health facilities, Laboratories, Medicaid,
Medicare, Reporting and recordkeeping requirements.
PART 493--LABORATORY REQUIREMENTS
Part 493 is amended as follows:
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), the sentence following sections 1861(s)(14),
1861(s)(15), and 1861(s)(16) of the Social Security Act (42 U.S.C.
263a, 1302, 1395x(e), the sentence following 1395x(s)(14),
1395x(s)(15), and 1395x(s)(16).
Sec. 493.855 [Amended]
2. In Sec. 493.855(a), ``January 1, 1994.'' is revised to read
``January 1, 1995, if available in the State in which he or she is
employed.''
3. Section 493.1202 is amended by revising the section heading to
change the expiration date from September 1, 1994 to September 1, 1996
and reads as follows:
Sec. 493.1202 Standard; Moderate or high complexity testing, or both:
Effective from September 1, 1992 to September 1, 1996.
5. In Sec. 493.1203, the section heading is revised to change the
effective date from September 1, 1994 to September 1, 1996 and read as
follows:
Sec. 493.1203 Standard; Moderate or high complexity testing, or both:
Effective beginning September 1, 1996.
Sec. 493.1443 [Amended]
6. Section Sec. 493.1443 is amended as set forth below:
a. In Sec. 493.1443(b)(3)(ii), ``September 1, 1994'' is revised to
read ``September 1, 1996''.
b. In Sec. 493.1443(b)(3)(ii)(C), ``September 1, 1994,'' is revised
to read ``September 1, 1996,''.
(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: August 24, 1994.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: September 6, 1994.
Philip R. Lee,
Assistant Secretary for Health.
Dated: September 28, 1994.
Donna E. Shalala,
Secretary.
[FR Doc. 94-29914 Filed 12-5-94; 8:45 am]
BILLING CODE 4120-01-P
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