[Federal Register Volume 65, Number 53 (Friday, March 17, 2000)]
[Proposed Rules]
[Pages 14510-14513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6580]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

Centers for Disease Control and Prevention

42 CFR Part 493

[HCFA-2233-N]
RIN 0938-AH35


CLIA Program; Cytology Proficiency Testing

AGENCY: Health Care Financing Administration (HCFA), Centers for 
Disease Control and Prevention (CDC), HHS.

ACTION: Withdrawal of proposed rule.

-----------------------------------------------------------------------

SUMMARY: This document announces the withdrawal of a proposed rule on 
cytology proficiency testing that was published in the Federal Register 
November 30, 1995 (60 FR 61509). We published the proposed rule to 
comply with a court order that we revise the regulations to require 
that cytology proficiency testing (PT) be conducted, ``to the extent 
practicable, under normal working conditions,'' which the court 
interpreted to be at a pace corresponding to the maximum workload rate 
for individuals examining cytology slides. After the proposed rule was 
published, the appeals court overturned the lower court's ruling and 
remanded the regulation to us for completion of rulemaking or to 
provide our rationale for the original position we took with respect to 
cytology proficiency testing. This document withdraws the proposed rule 
and also contains a supplementary statement of rationale, in accordance 
with the appeals court ruling.

DATES: The proposed rule is withdrawn as of April 17, 2000.

FOR FURTHER INFORMATION CONTACT: Rhonda S. Whalen (770) 488-8155.

SUPPLEMENTARY INFORMATION:  

I. Background

    On February 28, 1992, we published a final rule with comment period 
in the Federal Register (57 FR 7002) to implement the Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578). One 
provision of CLIA, section 353(f)(4)(B)(i) of the Public Health Service 
Act (PHS Act), required the Department to establish a limit on the 
maximum number of cytology slides that an individual could examine 
daily, in order to ensure that he or she has sufficient time to 
adequately examine each slide. CLIA also required

[[Page 14511]]

the Department to establish standards for the conduct of cytology 
proficiency testing (PT), with such testing ``to take place, to the 
extent practicable, under normal working conditions'' (section 
353(f)(4)(B)(iv) of the PHS Act).
    The February 28, 1992 final rule, at 42 CFR 493.1257(b)(1) and 
(b)(3)(i), established a maximum daily workload limit for personnel 
examining cytology slides in a normal work day. Under the regulations, 
cytology personnel may examine no more than 100 slides in any 24 hour 
period, and must have at least 8 hours to complete the examination of 
100 slides, which results in an average of 12.5 slides per hour. This 
limit was established in order to ensure that an individual has 
sufficient time to adequately examine each slide.
    CLIA also required the Department to develop a program for testing 
the proficiency of individuals who perform cytology examinations. The 
statute states that proficiency testing is to take place, to the extent 
practicable, under normal working conditions (section 353(f)(4)(B)(iv) 
of the PHS Act). The February 28, 1992 final rule, at Sec. 493.855(b), 
provides that an individual must complete a 10-slide proficiency test 
in 2 hours and, if necessary, a 20-slide test in 4 hours. We 
established a lower slide examination rate for PT because a test 
contains a higher number of abnormal slides than a cytologist would 
encounter in a normal work day. We believe that a test that uses a 
higher number of abnormal slides more accurately assesses the skills of 
the cytologist.

II. Court Challenge

    The Consumer Federation of America and Public Citizen challenged 
the regulations in the United States District Court for the District of 
Columbia, arguing that the PT rate of five slides per hour did not 
conform to normal working conditions, since it is substantially less 
than the 12.5 slides per hour maximum permissible workload. The 
district court agreed, invalidated that portion of the regulations, and 
ordered us to publish new proposed regulations, within 90 days of the 
order, that would modify the rate of cytology proficiency testing to 
ensure that individuals would be tested, to the extent practicable, 
under normal working conditions, which the district court interpreted 
to be at a pace corresponding to the maximum workload rate for 
individuals examining cytology slides. The district court order also 
provided that the February 28, 1992 final cytology proficiency testing 
regulations would remain in effect pending the issuance of a revised 
final rule. Consumer Federation of America and Public Citizen v. 
Department of Health and Human Services, 906 F.Supp. 657, 668 (D.D.C. 
1995).
    In compliance with the district court's order, we published a 
proposed rule in the Federal Register on November 30, 1995 (60 FR 
61509). The rule proposed to modify the timeframe for completing a 
cytology proficiency test to equal the maximum workload rate of 12.5 
slides per hour. However, in the preamble, we restated our belief that 
the timeframe in the original rule met the statutory requirement, and 
indicated the Department was appealing the district court's ruling, and 
seeking reinstatement of the February 28, 1992 cytology PT regulations.
    In a decision dated May 21, 1996, the United States Court of 
Appeals for the District of Columbia Circuit reversed the district 
court's ruling and sent back the regulation for us to either offer an 
adequate explanation for the original cytology PT rule or to complete 
the rulemaking (Consumer Federation of America and Public Citizen v. 
Department of Health and Human Services, 83 F.3d 1497, 1506-07 (D.C. 
Cir. 1996). We continue to believe that our regulations are 
appropriate, and we are supplying a supplementary statement that 
further explains the rationale behind our policy. Our supplementary 
statement of rationale follows in section IV. of this notice.

III. Withdrawal of Proposed Rule

    For the reasons discussed above, we are withdrawing the November 
30, 1995 proposed rule. We believe that the February 28, 1992 final 
rule appropriately fulfills the statutory requirement that cytology 
proficiency testing be conducted, to the extent practicable, under 
normal working conditions.

IV. Supplementary Statement of Rationale

    In compliance with the court's ruling, we received a memorandum 
from the Centers for Disease Control and Prevention (CDC) that sets 
forth the rationale for Cytology Proficiency Testing. This memorandum 
is part of the rulemaking record and appears as an addendum to this 
document.

    Authority: Section 353 of the Public Health Act (42 U.S.C. 
263a).

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program; 
and No. 93.774, Medicare--Supplementary Medical Insurance Program)

    Dated: March 29, 1999.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
    Dated: March 2, 1999.
Jeffrey P. Koplan,
Director, Centers for Disease Control and Prevention.
    Dated: May 14, 1999.
Donna E. Shalala,
Secretary.

    Note: This document was received at the Office of the Federal 
Register on March 13, 2000.

Addendum--Supplementary Statement of Rationale for Cytology 
Proficiency Testing

MEMORANDUM

September 1, 1998
TO: Sue Brown, Director, Division of Regulations and Issuances.
FROM: Carlyn Collins, M.D., M.P.H., Director, Division of Laboratory 
Systems.
SUBJECT: HSQ-176-FC; Supplement to Rulemaking Record Re: Cytology 
Proficiency Testing.
    This memorandum supplements the rulemaking record for HSQ-176-FC 
(57 FR 7002), which was published to implement the Clinical 
Laboratory Improvement Amendments of 1988 (CLIA). This memorandum is 
intended to provide further explanation for the timeframe 
established in that section of the CLIA final rule pertaining to 
completion of cytology proficiency tests (42 CFR 493.855). It is 
submitted to fulfill the order of the United States Court of Appeals 
for the District of Columbia Circuit in Consumer Federation of 
America and Public Citizen v. Department of Health and Human 
Services, 83 F.3d 1497 (D.C. Cir. 1996).

A. Background

    On February 28, 1992, the Department of Health and Human 
Services published a final rule with comment period in the Federal 
Register (57 FR 7002) to implement the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578, codified at 
42 U.S.C. 263a). One provision of CLIA, 42 U.S.C. 263a(f)(4)(B)(i), 
required the Department to establish a limit on the maximum number 
of cytology slides that a cytologist could examine daily, in order 
to assure that the cytologist had sufficient time to adequately 
examine each slide. CLIA also required the Department to establish 
standards for the conduct of cytology proficiency testing (PT), with 
such testing ``to take place, to the extent practicable, under 
normal working conditions.'' 42 U.S.C. 263a(f)(4)(B)(iv).
    The February 28, 1992 final rule established a maximum daily 
work rate of no more than 100 slides in a 24 hour period, which, 
assuming an eight hour workday, averaged 12.5 slides per hour. 42 
CFR 493.1257(b). The cytology PT requirement published in the final 
rule allows up to two hours for an individual to complete a 10-slide 
PT test, and up to four hours to complete a 20-slide PT test 
challenge. 42 CFR 493.855(b).

[[Page 14512]]

    The Consumer Federation of America and Public Citizen challenged 
the regulations in the United States District Court for the District 
of Columbia, arguing that the PT testing rate of five slides/hour 
did not conform to ``normal working conditions,'' since it is 
substantially less than the 12.5 slides/hour maximum permissible 
workload. The district court agreed, invalidated that portion of the 
regulations, and ordered the Department to publish new proposed 
regulations, within 90 days of the order, that would modify the rate 
of cytology proficiency testing to ensure that individuals would be 
tested ``to the extent practicable, under normal working 
conditions,'' which the district court interpreted to be at a pace 
corresponding to the maximum workload rate for individuals examining 
cytology slides. (The district court order provided that the 
February 28, 1992 final cytology proficiency testing regulations 
would remain in effect pending the issuance of a revised final 
rule.) Consumer Federation of America and Public Citizen v. 
Department of Health and Human Services, 906 F.Supp. 657, 668-669 
(D.D.C. 1995).
    In compliance with the district court's order, on November 30, 
1995, the Department published a Notice of Proposed Rulemaking 
(NPRM) in the Federal Register (60 FR 61509). The NPRM proposed to 
modify the timeframe for completing a cytology proficiency test to 
equal the maximum workload rate of 12.5 slides per hour. However, in 
the belief that the timeframe in the original rule met the statutory 
requirement, the Department appealed the district court's ruling, 
seeking reinstatement of the February 28, 1992 cytology PT 
regulations.
    In its May 21, 1996 decision, the United States Court of Appeals 
for the District of Columbia Circuit reversed the district court's 
ruling and remanded the regulation to the agency to proffer an 
adequate explanation for the original cytology PT rule or to 
complete the rulemaking. Consumer Federation of America and Public 
Citizen v. Department of Health and Human Services, 83 F.3d 1497, 
1506-07 (D.C. Cir. 1996).
    Under the analysis of Chevron U.S.A. Inc. v. Natural Resources 
Defense Council, Inc., 467 U.S. 837, 842-43 (1984), the court of 
appeals noted that ``[i]n reviewing an agency's construction of a 
statute, we first ask whether Congress has spoken unambiguously to 
the precise issue at hand. If it has, we give effect to Congress' 
intent. If not, we consider the agency's action under `Step Two' of 
Chevron, and defer to the agency's interpretation if it represents a 
`permissible construction' of the statute.'' 83 F.3d at 1503.
    The court of appeals found that the challenge to the Secretary's 
interpretation could not be resolved under the first prong of the 
Chevron analysis. By inserting the words ``to the extent 
practicable,'' to precede the language the proficiency testing is to 
take place ``under normal working conditions'' (42 U.S.C. 
263a(f)(4)(B)(iv)), the agency's interpretation did not require a 
precise replication of the workplace environment. In addition, 
Congress did not define with any precision when the Secretary could 
``deviate from workplace conditions in the interests of 
practicality.'' 83 F.3d at 1505. Because Congress did not address 
these issues, the court turned to the second prong of Chevron and 
inquired whether the agency's interpretation was reasonable.
    However, the court further stated that it was ``at a loss to 
understand how HHS's proficiency testing regulations reflect a 
reasonable interpretation of the relevant CLIA provision'' (83 F.3d 
at 1506), by noting that the Department's explanation of the 
cytology PT rate in the preamble to the final rule published on 
February 28, 1992 (57 FR at 7041) ``is simply too terse to support 
the agency's decision to use a [proficiency] testing rate which is 
less than half the maximum work rate, in the face of statutory 
language directing it to test under normal working conditions to the 
extent practicable.'' 83 F.3d at 1506.
    While indicating some interest in the Department's further 
explanation proffered during the course of the litigation (which 
corresponds with the statement in the next section of this 
memorandum), the court held that this explanation constituted a 
``post hoc'' rationalization, since this rationale was not proffered 
as part of the administrative record during the rulemaking process 
that resulted in the February 28, 1992 final rule. As such, the 
court noted that it was prohibited from considering it in its review 
of the legal basis for the final rule.
    In its ruling, the court remanded to the Department to either 
provide an adequate explanation on the record of why the proficiency 
testing protocol represents a permissible interpretation of the 
pertinent CLIA provision or to continue the rulemaking process 
commenced with the issuance of the NPRM on November 30, 1995.
    After further consideration of this issue, CDC believes that the 
final rule of February 28, 1992 appropriately fulfills the statutory 
requirement that cytology proficiency testing be conducted ``to the 
extent practicable, under normal working conditions.'' We understand 
that a notice withdrawing the proposed rulemaking of November 30, 
1995 will be published in the Federal Register. Furthermore, through 
this memorandum CDC ``provide[s] an adequate explanation on the 
record of why the proficiency testing protocol represents a 
permissible interpretation'' of the CLIA statute, as required by the 
court.

B. Supplemental Statement of Rationale for Timeframe in Cytology 
Proficiency Testing Final Rule Published February 28, 1992

    As required by CLIA, the final rule established a maximum 
workload limit for personnel examining cytology slides. Under the 
regulations, cytologists may examine no more than 100 slides in any 
24 hour period, and must have at least 8 hours to complete the 
examination of 100 slides. 42 CFR 493.1257(b)(1), (b)(3)(i). This 
limit was established in order to assure that individuals who 
perform cytology testing have sufficient time to adequately examine 
each slide.
    CLIA also requires the Department to develop a program for 
testing the proficiency of individuals who perform cytology slide 
examinations. The statute states that proficiency testing is ``to 
take place, to the extent practicable, under normal working 
conditions.'' 42 U.S.C. 263a(f)(4)(B)(iv). The February 28, 1992 
final rule implementing the testing program (42 CFR 493.855(b)) 
provides that cytology personnel will be required to complete a 10-
slide proficiency test in two hours and, if necessary, a 20-slide 
test in four hours.
    The regulation proposed in the original NPRM of May 21, 1990 (55 
FR 20896, 20928) did not include time limits for cytology 
proficiency testing. In developing the final rule, we reviewed the 
PT program that had been in operation in Maryland since 1990. This 
program had been submitted by the Maryland Department of Health and 
Mental Hygiene as a model for revising the cytology PT program 
proposed in the NPRM. As noted in the preamble to the final rule 
published on February 28, 1992 (57 FR at 7041), we adopted the same 
time limits used in the Maryland program. ``These time limits,'' we 
explained, ``were established to provide for equitable testing on a 
national scale and to allow individuals sufficient time to complete 
the test at their normal pace without unduly restricting or 
extending the time for the examination.'' We concluded that the time 
limits in the Maryland program, which require cytologists to review 
5 slides per hour, satisfied CLIA's requirement that PT take place, 
``to the extent practicable, under normal working conditions.''
    We reached this conclusion even though a cytologist who reviews 
the maximum number of slides allowed per day will screen, on 
average, approximately 12.5 slides per hour.
    1. First, and most importantly, we acknowledge, consistent with 
CLIA, that it is not ``practicable'' to precisely duplicate a 
typical working day when designing a supervised, time-limited 
proficiency testing program. Approximately 95% of the usual mix of 
cytology slides from patients are normal. Creating a proficiency 
test with this ratio of normal to abnormal slides, however, would 
not accurately assess the skills of the cytologist because it would 
not test the cytologist's knowledge of the full range of possible 
abnormalities. Consequently, under 42 CFR 493.945, the 10-slide set 
for a PT exam must have at least 30%, and may have up to 60% 
abnormal slides. In setting the 5-slide-per-hour rate, we took into 
account that the evaluation of abnormalities generally requires more 
time, whether it occurs during a normal working day or during 
proficiency testing. Indeed, some slides in the test may require 
extensive evaluation and considerable time. Therefore, an absolute 
comparison of normal workday rates with proficiency testing rates is 
inappropriate. Since the proportion of complex, abnormal slides will 
be much greater during proficiency testing than during a normal 
workday, it is not practicable to demand that cytologists examine 
proficiency testing slides at the maximum rate that they are 
permitted to work during a normal day. A slower-than-average work 
rate during proficiency testing is appropriate because examining 
abnormal slides generally takes more time than examining normal 
slides.
    2. Second, we did not assume that ``under normal working 
conditions'' cytologists will

[[Page 14513]]

examine 100 slides each day. When setting this limit, we explicitly 
stated that it ``represents an absolute maximum number of slides and 
is not to be employed as a performance target for each individual.'' 
42 CFR 493.1257(b)(1). Similarly, when designing the proficiency 
testing program, we recognized that due to varying skill levels, and 
other factors, some cytologists will work at a much slower pace than 
others. Since the proficiency program is designed to allow all 
individuals to work at their normal speed, the rate for proficiency 
testing was set below the maximum rate at which cytologists may work 
under the regulations.
    3. Third, we also decided that the slide-per-hour rate should be 
lower during proficiency testing than during normal workdays because 
the staining characteristics of the proficiency test slides may be 
different from those prepared in the test subject's laboratory, 
forms for recording results will be unfamiliar, and the test will 
create some anxiety for the cytologist. To account for these 
factors, we determined that extra time should be allowed.
    In light of the experience of the Maryland program, and the 
factors mentioned above, we determined that the 2 and 4 hour time 
limits for proficiency testing are appropriate because they take 
into account the differences between examination of slides during 
normal workdays and during a proficiency test.
    Given the proficiency testing situation described above, CDC 
reaffirms that the timeframe established in the February 28, 1992 
final rule for completion of cytology proficiency tests is, ``to the 
extent practicable,'' comparable to normal working conditions, and 
fulfills the Congressional intent to test adequately the abilities 
of cytologists to determine test results accurately.
Carlyn L. Collins.

[FR Doc. 00-6580 Filed 3-16-00; 8:45 am]
BILLING CODE 4120-01-P