[Federal Register Volume 59, Number 233 (Tuesday, December 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29914]


[[Page Unknown]]

[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