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The proposed rule is withdrawn as of April 17, 2000.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 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 § 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)

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).

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 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.