[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Proposed Rules]
[Pages 3264-3294]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-804]



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Part V





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Part 493



Medicare, Medicaid, and Clinical Laboratory Improvement Amendments of 
1988 (CLIA) Program; Cytology Proficiency Testing (PT); Proposed Rule

Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / 
Proposed Rules

[[Page 3264]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 493

[CMS-2252-P]
RIN 0938-A034


Medicare, Medicaid, and Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) Program; Cytology Proficiency Testing (PT)

AGENCIES: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would amend the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) regulations for cytology 
proficiency testing (PT), to reflect changes in cytology laboratory 
operations and practices. The proposed changes are based on 
recommendations received from the Clinical Laboratory Improvement 
Advisory Committee (CLIAC), input from the professional community, and 
government experience with the implementation of cytology PT. The 
proposed changes would amend certain definitions, lengthen the testing 
interval, require validation of cytology challenges before use in 
testing, increase the minimum number of cytology challenges per testing 
event, change the grading scheme, and allow flexibility to accommodate 
new technologies (for example, digital images, as they are implemented 
in cytology laboratory practice).

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on March 17, 2009.

ADDRESSES: In commenting, please refer to file code CMS-2252-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the instructions under 
the ``More Search Options'' tab.
    2. By regular mail. You may mail written comments to the following 
address only: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-2252-P, P.O. Box 8016, 
Baltimore, MD 21244-1850.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address only: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-2252-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original) before the close of the 
comment period to either of the following addresses:
    a. Room 445-G, Hubert H. Humphrey Building, 200 Independence 
Avenue, SW., Washington, DC 20201.
    (Because access to the interior of the Hubert H. Humphrey (HHH) 
Building is not readily available to persons without Federal Government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. 7500 Security Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
please call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    Submission of comments on paperwork requirements. You may submit 
comments on this document's paperwork requirements by following the 
instructions at the end of the ``Collection of Information 
Requirements'' section in this document.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Nancy Anderson, CDC, (404) 498-2280. 
Judy Yost, CMS, (410) 786-3531.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following Web site as soon as possible after they have been 
received: http://www.regulations.gov. Follow the search instructions on 
that Web site to view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

I. Background

A. Origin for Cytology PT

    In 1987, articles in The Wall Street Journal questioned the 
competence of laboratories that examined Papanicolaou (Pap) smears and 
attributed misdiagnosed cases of cancer to ``excessive workloads of 
cytotechnologists, lack of quality control procedures, and poorly 
educated personnel.'' Walt Bogdanovich, Lax Laboratories: the Pap Test 
Misses Much Cervical Cancer Through Labs' Errors, The Wall Street 
Journal, November 2, 1987, at A:1, Column 6. Walt Bogdanovich, 
Physicians' Carelessness with Pap Tests is cited in Procedure's High 
Failure Rate, The Wall Street Journal. December 29, 1987, at A:17, 
Column 4.
    Following the public outcry, Congress held hearings in both the 
House of Representatives and the Senate in the spring of 1988. The 
House of Representatives Committee on Energy and Commerce's report on 
the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public 
Law 100-578, stated ``The Committee does not intend for the Secretary 
to exempt analytes from proficiency testing merely because such testing 
is not currently available or because it is difficult to obtain 
consensus of the best method of proficiency testing,'' as is the case 
with cytology PT. See, H.R. Rep. No. 100-899, at p. 31 (1988), 
reprinted in 1988 U.S.C.C.A.N. 3828, 3850. The Secretary was 
specifically instructed to ``develop, or foster the development of, a 
proficiency test for cytology slides and to conduct, or require 
approved proficiency testing agencies to conduct, some onsite 
proficiency testing''. Id. at 3852. The corresponding Senate report 
stated that a ``* * * lack of a national proficiency testing system is 
of particular concern in the area of cytology * * * and that lack of a 
Federal proficiency testing requirement and other quality assurance 
standards for cytology may endanger the health of

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American women.'' See, S. Rep. No. 561, 100th Cong., 2nd Sess. 3-4 
(1988).

B. Statutory History

    The CLIA amended section 353 of the Public Health Service Act 
(PHSA) (42 U.S.C. 263a). Among other things, CLIA established minimum 
standards for all clinical laboratories in the United States performing 
testing on human specimens for health purposes. The CLIA statute 
required the Secretary of the Department of Health and Human Services 
(HHS) to develop standards that included personnel qualifications and 
quality control and quality assurance procedures, and required PT as 
one measure of ensuring quality laboratory testing. The general 
laboratory PT requirements at section 353(f)(3)(A) state: ``The 
Secretary shall establish standards for the proficiency testing 
programs * * * The testing shall be conducted on a quarterly basis, 
except where the Secretary determines for technical and scientific 
reasons that a particular examination or procedure may be tested less 
frequently (but not less often than twice per year).'' The cytology PT 
requirements at section 353(f)(4)(B)(iv) vary from the general 
laboratory PT requirements. They require ``periodic confirmation and 
evaluation of the proficiency of individuals involved in screening or 
interpreting cytological preparations, including announced and 
unannounced on-site proficiency testing of such individuals, with such 
testing to take place, to the extent practicable, under normal working 
conditions.''

C. Initial Efforts to Implement Cytology PT

1. Proposed Rule Implementing Cytology PT
    In implementing these statutory requirements, CMS proposed cytology 
PT standards keyed to the individuals who perform the cytology 
examinations, in accordance with section 353(f)(4)(B)(iv).
    On May 21, 1990, we published a proposed rule in the Federal 
Register (55 FR 20896), to establish requirements for CMS approval of 
PT programs including gynecologic cytology. The rule proposed that 
programs would be required to use 20 glass slides to test the 
proficiency of individuals examining Pap smears twice a year. To ensure 
that all individuals would be able to be tested twice each year, CMS-
approved cytology PT programs would be required to provide one 
unannounced on-site testing event in each laboratory, and no fewer than 
four announced testing events in each State on an annual basis. CMS 
would designate the testing sites. The glass slides were to be 
referenced with a minimum 80 percent agreement in a scientifically 
defensible manner by at least five physicians certified in anatomic 
pathology. The diagnosis of each glass slide was to be placed into one 
of four categories that were based on 1988 Bethesda System terminology 
(that is, unsatisfactory, normal or negative (infection, reactive and 
reparative changes), low grade squamous cell abnormalities and high 
grade squamous cell abnormalities (which also included glandular cell 
abnormalities and non-epithelial malignant neoplasm). Test slides 
demonstrating premalignant and malignant lesions were to be confirmed 
by biopsy with an 80 percent consensus agreement of at least five 
physicians.
    The proposed rule envisioned cytology PT programs using one grading 
scheme for both pathologists and cytotechnologists. This grading system 
was to award -1 to 2 points per challenge. The individual's score was 
to be calculated by adding the point values achieved for each slide, 
dividing it by the total points for the testing event, and multiplying 
it by 100. For a 100 point test, the proposed passing score was 80 
percent. A rescreen of 500 slides was proposed for any individual who 
failed the first test event. Any cytotechnologist who failed also had 
to receive immediate remedial training and education.
    In response to the proposed rule, we received 900 letters 
containing approximately 1700 comments on cytology PT participation and 
470 comments on the proposed requirements for approval of cytology PT 
programs. The major issues identified in the comments to the cytology 
PT proposed rule were: Biannual testing of individuals rather than 
testing the laboratory; announced on-site PT versus mailed PT; content 
of a PT event (number of slides, test material); evaluation of 
pathologists and cytotechnologists in the same manner, rather than in 
the context of duties performed; use of the 1988 Bethesda System for 
reporting PT results; and remedial education and rescreening 
requirements following failure of a single PT event.
2. Final Rule With Comment
    On February 28, 1992, we published a final rule with comment in the 
Federal Register (57 FR 7002). The provisions established in that final 
rule with comment are still in effect. In response to the public 
comments on the proposed rule, and based on the experience of State 
cytology PT programs, we established various requirements at 42 CFR 
part 493. Section 493.855 requires each laboratory to ensure that each 
individual examining gynecologic cytology preparations enrolls in a 
CMS-approved PT program by January 1, 1995, if a program is available, 
and, participates in at least one (announced or unannounced) PT event 
per year and obtains a passing score. Testing must be offered on-site 
at least once per year in each laboratory using a 10 glass slide test 
set. Individuals must score at least 90 percent to successfully 
complete the test. Any individual who does not score at least 90 
percent on the first testing event must be retested using a 10 slide 
test within 45 days.
    If the individual does not score at least 90 percent on the second 
testing event, the laboratory must provide him or her with documented 
remedial training in the area of failure and must ensure that all 
gynecologic preparations examined by this individual subsequent to the 
notice of failure are re-examined by someone in the laboratory who 
obtained at least 90 percent on the cytology PT during the current 
year. The individual must be retested with a 20 slide test set and 
score at least 90 percent in order to pass the PT event. If the 
individual does not score at least 90 percent on the third test, the 
individual must cease examining patient gynecologic slide preparations 
immediately upon notification of test failure and not resume examining 
gynecologic slides until the laboratory ensures the individual obtains 
at least 35 hours of documented formally structured continuing 
education. The individual must then be retested on a 20 slide test set 
and score at least 90 percent to pass the test. As provided for at 42 
CFR 493.855, ``[i]f a laboratory fails to ensure that individuals are 
tested or those who fail a testing event are retested, or fails to take 
required remedial actions * * * CMS will initiate intermediate 
sanctions or limit the laboratory's certificate to exclude gynecologic 
cytology testing under CLIA, and, if applicable, suspend the 
laboratory's Medicare and Medicaid payments for gynecologic cytology 
testing in accordance with subpart R of this part.'' The individual may 
be retested indefinitely after a third failure, but may not resume 
examining gynecologic specimens until he or she scores at least 90 
percent.
    Section 493.945 of Subpart I, ``Proficiency Testing Programs for 
Nonwaived Testing,'' describes requirements for CMS approval of 
gynecologic cytology PT programs. To be approved, each program must

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provide 10 and 20 glass slide test sets that represent the four 
diagnostic categories (unsatisfactory, negative-benign, low grade 
squamous intraepithelial lesions, and high grade squamous 
intraepithelial lesions) as defined in Sec.  493.945(b)(3)(ii)(A), and 
the test sets must be comparable to ensure equitable testing within and 
between PT programs. The programs are required to provide on-site 
testing for each individual enrolled at least once per year including 
announced and unannounced testing events, and must provide retesting 
for those individuals who fail any testing event. Technical supervisors 
(pathologists), who do not perform primary screening (that is, who only 
examine slides after they have been prescreened by a cytotechnologist) 
may be tested on slides that have been prescreened to locate 
potentially abnormal cells by a cytotechnologist who examines slides in 
their laboratory. There are separate scoring schemes for 
cytotechnologists and technical supervisors that award -5 to 10 points 
based on the proximity of the individual's response to the correct 
response. Individuals receive a maximum of 10 points for every correct 
response. One provision requires deducting 5 points from an individual 
who responds that a slide is negative when the correct response is a 
high grade squamous intraepithelial lesion (HSIL) or cancer (Category 
D). (An HSIL or cancer (Category D) lesion is one that would require 
immediate follow-up and treatment due to its severity including: 
Moderate dysplasia, severe dysplasia, or carcinoma-in-situ or a 
cancer.) This individual would obtain a score of less than 90 percent 
even if every other slide in the test set was correctly identified 
resulting in test failure. In this case, the individual would score 90 
points for 9 correct responses and -5 points for incorrectly 
identifying an HSIL or cancer (Category D) as normal or benign. (The 
final score would be calculated by deducting 5 points from 90 points 
for a total of 85 points.)
3. Response to Comments to the February 28, 1992 Final Rule With 
Comment
    Following publication of the February 28, 1992 final rule with 
comment, we received nearly 300 comments on the cytology PT 
requirements. Approximately 90 comments addressed participation in 
cytology PT and over 200 comments addressed the cytology PT programs. 
The majority of the commenters stated opposition to the cytology PT 
requirements, and voiced concern about the feasibility and costs 
associated with the development of a national glass slide PT program 
that included on-site testing of individuals. Some comments stated that 
national testing of individuals could not be achieved using glass 
slides. One organization suggested using media other than glass slides 
for testing. Other commenters were opposed to the frequency of annual 
testing, the 90 percent passing score, inclusion of unsatisfactory in 
the response categories, and grading cytotechnologists in any manner 
other than based on their ability to separate unsatisfactory or 
negative categories from those requiring review by the technical 
supervisor.
4. Final Rule Extending Cytology PT Enrollment Date
    As of January 1, 1994, (the enrollment deadline specified in the 
February 28, 1992 final rule with comment), no cytology PT program had 
met the CLIA requirements for approval. On December 6, 1994, we 
published a final rule with comment (59 FR 62606) in the Federal 
Register, to allow additional time for programs to seek approval as a 
cytology PT provider, and to allow individuals an extension of the 
compliance date for enrollment in a CMS-approved cytology PT program.
    The December 6, 1994 final rule with comment changed the compliance 
date for cytology PT enrollment from January 1, 1994 to January 1, 
1995. Under that rule, enrollment was required by the compliance date 
if a CMS-approved program was available in the State in which the 
individual was employed. For individuals engaged in the examination of 
gynecologic cytology preparations who were employed in a State in which 
a CMS-approved cytology PT program was not available beginning January 
1, 1995, enrollment and participation in a CMS-approved cytology PT 
program would be required at the point that a program became available.
5. Litigation Regarding the February 28, 1992 Regulations
    On January 14, 1993, the Consumer Federation of America and Public 
Citizen filed a lawsuit in the United States District Court for the 
District of Columbia (the Court), challenging the HHS implementation of 
CLIA (Consumer Federation of American and Public Citizen v. HHS, 906 F. 
Supp., 657 (D. D.C. 1995), reversed in part and remanded in part). 
Among other things, plaintiffs argued that the cytology PT regulations 
violated the statutory mandate for cytology PT to ``* * * take place, 
to the extent practicable, under normal working conditions, * * *'' The 
plaintiffs' suit indicated that the February 28, 1992 final rule with 
comment limited cytotechnologists to examining no more than 100 slides 
in a 24 hour period, and that they must be allowed at least 8 hours to 
complete the examination of 100 slides. These provisions result in an 
average rate of review of 12.5 slides per hour. However, with respect 
to PT, the February 28, 1992 final rule with comment included a lower 
slide examination rate of 5 slides per hour (the 10 slide test was to 
be completed within 2 hours and the 20 slide test was allotted 4 
hours).
    On August 29, 1995, the Court ruled that the regulations did not 
strictly conform to the statutory mandate. The Court ordered HHS to 
engage in expedited rulemaking (within 90 days of its order), to 
publish a proposed rule in the Federal Register requesting public 
comment on the PT regulations for cytology personnel in light of 42 
U.S.C. 263a(f)(4)(B)(iv) (providing that individuals should be tested, 
to the extent practicable, under normal working conditions). The 
existing regulations were to remain in effect pending the issuance of a 
final rule as specified by the Court.
    In accordance with the Court's order, on November 30, 1995, we 
published a proposed rule in the Federal Register (60 FR 61509). The 
rule proposed changing the provisions that authorized the examination 
of cytology PT slides at a rate of 5 slides per hour to a rate of 12.5 
slides per hour. In order to achieve this PT workload rate, the rule 
proposed changing the cytology PT 10 slide test's duration from 2 hours 
to 45 minutes per testing event. The rule also proposed to limit the 
time for a 20 slide retest to 90 minutes instead of 4 hours. The 
proposed rule stated that there might be other options for complying 
with the statutory mandate (providing that individuals should be 
tested, to the extent practicable, under normal working conditions), 
and specifically requested comments on options.
    We received approximately 760 comments in response to the proposed 
rule from cytotechnologists, pathologists, professional organizations, 
and other members of the public. Nearly 100 percent of the comments 
stated opposition to the proposed rate change. Commenters stated that 
PT differs from the working conditions associated with the examination 
of patient specimens; therefore, the time frame for a PT examination 
should not be equated to an individual's workload rate. Reasons cited 
for opposing the proposed PT workload rate change included the 
following:

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     Cytology PT requires screening a higher number of abnormal 
slides than is routinely seen in the patient workload.
     The individual's workload limit is a maximum rate and not 
a target rate.
     The staining of PT slides may vary from the laboratories' 
patient slides.
     The individual screening rates differ.
     The reporting format for PT results is different from the 
laboratory format.
     There is more stress associated with PT.
    Approximately 350 comments were received in response to the 
proposed rule's request for comments on expanding the CLIA provisions 
to permit the use of computer-based proficiency testing (CBPT) as an 
alternative to glass slide proficiency testing (GSPT). While a number 
of the comments indicated that individuals were apprehensive about a 
CBPT program, many commenters stated that a national GSPT program was 
not feasible and provided suggestions for implementing a CBPT program.
    HHS appealed the District Court's ruling and sought to re-establish 
the cytology PT testing time frame established in the February 28, 1992 
final rule with comment. In a decision dated May 21, 1996, the United 
States Court of Appeals for the District of Columbia reversed and 
remanded those aspects of the District Court's ruling. It provided that 
HHS could either offer an adequate explanation for the original 
cytology PT rule and reinstate that rule or issue a final rule in 
response to the comments received on the November 30, 1995 proposed 
rule (60 FR 61509) (Consumer Federation of America and Public Citizen 
v. Department of Health and Human Services, 83 F.3d 1497, 1506-07 (D.C. 
Cir. 1996)).
    On March 17, 2000, we published a notice in the Federal Register 
(65 FR 14510) withdrawing the November 30, 1995 proposed rule, 
providing further explanation of the rationale behind the 1992 cytology 
PT provisions and reinstating the time frame for PT contained in the 
February 28, 1992 final rule with comment. The rationale provided 
further explanation for the original cytology PT rule provisions on 
test duration as required by the Court. It documented that the time 
provided for testing represented as reasonable an approximation of 
normal working conditions is possible under the circumstances. In the 
supplementary statement, HHS noted that the February 28, 1992 final 
rule with comment stipulated time frame for cytology PT of 5 slides per 
hour was based on the time frame used by the cytology PT program 
developed by the State of Maryland. CMS concluded that this time frame 
would provide for equitable testing on a national scale allowing 
individuals sufficient time to complete the test at their normal pace, 
without unduly restricting or extending the time for examination. This 
conclusion was reached even though a cytotechnologist who reviews the 
maximum number of slides per day would screen approximately 12.5 slides 
per hour. In the supplementary statement, HHS provided the following 
reasons for this conclusion: (1) A workload of 100 slides is the 
maximum allowed and not all cytology personnel examine 100 slides each 
day; (2) PT includes a higher ratio of abnormal to normal slides and 
should appropriately take longer to review; and (3) PT may include 
slides with different staining characteristics and test result forms 
that could be unfamiliar to the cytology personnel and require extra 
time for reporting results. HHS determined that the 2 hours to examine 
a 10 slide PT test set and 4 hours to examine a 20 slide PT retest used 
by the Maryland program were appropriate and took into account 
differences between examination of slides during normal workdays and 
during PT.

D. Implementing Cytology PT

1. Request for Proposal
    No PT programs requested CMS approval in time for the regulatory 
deadline of July 1st of each calendar year for nationwide cytology PT 
testing. In an effort to obtain the 26,000 referenced Pap smears 
estimated to be needed to provide for a national cytology PT program, 
the CDC issued a Request for Proposal (RFP) in March 1993, for a 
contractor to undertake procurement of the glass slides for use in 
administering the program. Although CDC did not receive any proposals 
in response to the RFP, they did receive comments from cytology 
organizations and individuals that echoed the comments previously 
received in response to the final regulations. The commenters stated 
that conducting a national GSPT program with on-site testing of 
individuals was logistically and financially infeasible, due to the 
expense associated with collecting the requisite number of high-quality 
glass slides representing appropriate diagnostic categories, and the 
time that would be needed to assemble, reference, and maintain the 
collection of slides.
2. 1993 Symposium
    In November 1993, the CDC and CMS cosponsored a cytology symposium 
with the Cytology Education Consortium, (which at that time was 
composed of the American Society for Clinical Pathology (ASCP), the 
American Society of Cytology (ASC), the American Society for 
Cytotechnology (ASCT)), and the College of American Pathologists (CAP), 
to consider possible alternatives to a national cytology PT program 
using glass slides. A number of approaches were discussed, including 
state-administered glass slide programs, mailed glass slide programs, 
and programs that use photographic image representations (that is, 
color transparencies, color plates, or digitized computer images) of 
glass slide specimens instead of glass slides. It was determined that 
the most promising strategy would be to develop a variety of cytology 
PT programs to accomplish the mandate specified in Section 
353(f)(4)(B)(iv) of the PHS Act--``* * * proficiency testing of such 
individuals, with such testing to take place, to the extent 
practicable, under normal working conditions, * * *.''
3. Clinical Laboratory Improvement Advisory Committee (CLIAC) 
Recommendations
    The Secretary of HHS is authorized by the Public Health Service Act 
to establish advisory committees. The Clinical Laboratory Improvement 
Advisory Committee (CLIAC) was established on February 19, 1992 to 
provide scientific and technical advice to HHS. CLIAC membership 
consists of subject matter experts in laboratory medicine, pathology, 
public health, clinical practice, as well as a consumer representative 
and a liaison from private industry. Ex officio members represent the 
HHS agencies that administer the CLIA Program. On December 13, 1993, a 
CLIAC cytology subcommittee met to review alternative approaches to 
cytology PT. This meeting was suggested during the 1993 symposium to 
provide recommendations for consideration by CLIAC. The CLIAC met on 
December 14 through 15, 1993 to consider the recommendations of the 
cytology subcommittee. After deliberation, the committee endorsed those 
recommendations. The CLIAC recommended: (1) That research studies be 
conducted to define outcomes and evaluate the effectiveness of both 
glass slide and alternative cytology PT programs; (2) that regulatory 
revisions be promulgated, as needed, to permit approval of alternative 
programs; and (3) that statutory changes be pursued to allow cytology 
PT requirements, like PT requirements for other specialties and 
subspecialties, to be applied to the laboratory as a whole rather than 
to individuals. The CLIAC also encouraged

[[Page 3268]]

professional organizations and States to develop appropriate programs 
to meet the February 28, 1992 final rule with comment requirements and 
make PT available for cytology personnel. The formal proceedings of 
this CLIAC meeting can be found at the following Web site: http://www.cdc.gov/cliac/.
4. Cooperative Agreements to Explore Computer-Based PT
    In September 1994, CDC awarded three 1-year cooperative agreements 
to promote the development of CBPT programs and to evaluate the 
acceptability of these programs by cytology personnel. These awards 
were made to the ASCP, New England Medical Center, and Thomas Jefferson 
University. The three CBPT prototypes were pilot tested at the 1995 
spring meetings of ASCP/CAP and the ASCT. More individuals indicated 
that they preferred the CBPT (68 percent) over GSPT. However, 
respondents indicated that the three cooperative agreements' CBPT 
programs did not include a mechanism to fully evaluate locator skills. 
(Locator skills are those skills necessary to find the abnormal cells 
on gynecologic cytology preparations.) The three CBPT prototypes were 
presented to CLIAC in March 1996. The CLIAC stated that the prototypes 
were adequate to test identification skills, but encouraged CDC to 
continue development of a prototype that would test locator skills.
5. CDC Computer-Based Prototype, CytoView\TM\
    The recommendations from the cooperative agreement pilot 
evaluations were incorporated into the CBPT prototype developed by CDC, 
named CytoView\TM\. A full description of this prototype was published 
in Acta Cytologica. See, Taylor R.N., Gagnon M.C., Lange J.V., Lee 
T.L., Draut R., Kujawski E.: CytoView\TM\: A Prototype Computer Image-
Based Papanicolaou Smear Proficiency Test, 43 Acta Cytologica 1045-1051 
(1999). The first CytoView\TM\ prototype was developed in October 1996 
and demonstrated to CLIAC in January 1997.
6. Evaluation of PT as a Measure of Workplace Performance
    In January 1995, CDC awarded a 2 year contract to Analytical 
Sciences Incorporated, to compare the actual work performance of 
cytology personnel with their PT performance. For each individual, the 
contractor rescreened 500 previously reported cases to determine a 
score for individual work performance. The work performance score was 
then compared to two methods of PT: (1) A GSPT administered by the 
contractor; and (2) the CytoView\TM\ prototype CBPT administered by the 
CDC. The study, based on a sample of 85 participants consisting of 
cytotechnologists (73) and pathologists (12) across the U.S. who 
performed primary screening (that is, examined slides without the 
assistance of a prescreening cytotechnologist), was completed in the 
spring of 1997.
    The results of the study were published in the American Journal of 
Clinical Pathology [Keenlyside R., Collins C.L., Hancock J.S., et al.: 
Do Proficiency Test Results Correlate with the Work Performance of 
Screeners Who Screen Papanicolaou Smears? (112) American Journal of 
Clinical Pathology. 769-776 (1999)]. The authors reported a moderate 
correlation (that is, unlikely to be a chance finding) between 
performance scores on the 500 slide rescreen and both the GSPT and 
CBPT. The research model had several limitations including: comparing a 
10 slide test to the rescreen of 500 slides; for a few individuals all 
four diagnostic categories were not present in the 500 slide rescreen; 
glass slides used in the GSPT and images used in the CBPT were not 
field validated; and the 42,500 slides rescreened by the 85 
participants were not referenced by 3 pathologists.
    Study participants were asked to evaluate CytoView\TM\ after 
completion of the CBPT. While 64 percent of the responses stated that 
the CBPT was an acceptable alternative, 68 percent favored GSPT. 
Negative comments about CytoView\TM\ included: The program was slow; 
the operating system was bulky; an optimal focal plane was not always 
available; and it did not test the workplace performance of the 
majority of pathologists, since they were required to screen the entire 
image.
7. CytoView\TM\ II Development
    CytoView\TM\ II was developed in June 1999 by the CDC based on 
comments received from the CytoView\TM\ evaluation questionnaire. 
CytoView\TM\ II operates from a laptop computer, displaying images at a 
faster speed with a fluid focusing mechanism that more closely 
simulates the microscope and provides an instant display of the field 
of view at a higher magnification with a single mouse click. An 
additional feature allows tandem screening by a cytotechnologist or 
pathologist team. The cytotechnologist marks (dots) areas of the slide 
and can write comments for the pathologist to review. The pathologist 
may then review only the marks, the entire slide, or a combination of 
the two features. The CytoView\TM\ II prototype was demonstrated at the 
1999 fall meetings of the ASCP/CAP and ASC.
    CDC trademarked the name CytoView\TM\ and in November 2000 a patent 
was issued on MicroScreen, the software used to capture the interactive 
images used by CytoView\TM\.
8. Comparison of Glass Slide Testing to Computer-Based Testing
    In July 2002, CDC completed a study with the Maryland Cytology 
Proficiency Testing Program (MCPTP) comparing PT in gynecological 
cytology using glass slides to virtual slides using the CytoView\TM\ II 
prototype. To compare performance, a total of 111 individuals (52 
pathologists and 59 cytotechnologists) from participating in-state 
laboratories were administered the two proficiency tests. The routine 
annual test of the MCPTP was administered to individuals following 
normal practice. CytoView\TM\ II was designed to emulate the MCPTP 
glass slide examination in which the individual selects the order of 
slide viewing and may change answers up until the test is submitted. 
Like the glass slide test, when a pathologist chose to examine a marked 
test, CytoView\TM\ II allowed the pathologist to review areas marked by 
the cytotechnologist and to see the diagnostic category chosen by the 
cytotechnologist. The slides used by the MCPTP were validated during 11 
years of testing. The virtual slides were captured from the MCPTP's 
glass slides but were not field validated as images. The study 
recognized the need for field validation of all slides (glass and 
virtual) and concluded that, if both glass and virtual slides are 
referenced and field validated, the result of testing would be 
equivalent. This study was published in Acta Cytologica [Gagnon M., 
Inhorn S., and Hancock J., et al., Comparison of Cytology Proficiency 
Testing-Glass Slides vs. Virtual Slides, 48 Acta Cytologica 788-794 
(2004).] If digital images are permitted as cytology PT challenges, 
this system could be available for cytology PT.
9. Approval of Programs
    Two State-operated programs applied for CMS approval in 1993. The 
MCPTP met the regulatory cytology PT requirements and was subsequently 
granted CMS approval in May 1994 for testing to begin calendar year 
1995. The MCPTP developed its cytology program to provide PT for all 
individuals (in-state and out-of-state) who evaluate gynecologic 
cytology preparations from residents of Maryland. The MCPTP did not 
possess sufficient materials to offer cytology PT nationally. After 
applying for approval in 1993, the Wisconsin

[[Page 3269]]

Cytology Proficiency Testing Program subsequently withdrew its 
application for approval in October 1994, when Wisconsin was unable to 
obtain a sufficient number of referenced glass slides necessary to 
provide a statewide program.
    In 1997, the CAP submitted an application to become an approved 
cytology PT program. The CAP requested the use of in-house proctors, 
selected from the laboratory's staff, to administer the PT. The CDC and 
CMS agreed with the proposal to use proctors to administer the PT and 
notified CAP of its determination. However, the initial application as 
well as subsequent submissions (1997 through 2004) that CAP provided to 
the agencies were not in conformance with the CLIA regulatory 
requirements and could not be approved. In November 2004, the 
submissions were ultimately withdrawn by CAP and replaced with a 
significantly revised and more comprehensive application in March 2005.
    In March 2004, The Midwest Institute for Medical Education (MIME) 
submitted an application for approval of a gynecologic cytology PT 
program under CLIA. After careful review, the program was approved and 
national testing of all individuals was required beginning on January 
1, 2005.
    In December 2004, CMS mailed a memorandum to the Directors of State 
Survey agencies informing them of the enforcement responsibilities 
effective for calendar year 2005. The memorandum stated that the PT 
implementation was to first emphasize an educational approach and that 
no sanctions would be imposed against laboratories unless they failed 
to comply with the following dates: (1) Ensure that all individuals are 
enrolled in a CMS approved cytology PT program by June 30, 2005; (2) 
ensure all individuals have been tested at least once by April 2, 2006; 
and (3) ensure that affected individuals achieve a passing score by 
December 31, 2006.
    In December 2004, CMS also held conferences with the CMS regional 
offices and State Agencies to provide information on the enforcement 
dates that laboratories must meet. In January 2005, CMS mailed 
individual letters to all laboratories certified in cytology notifying 
them of the required enrollment and participation in a CMS-approved 
cytology PT program for all individuals examining gynecologic 
preparations. In February 2005, CMS held a Partners in Laboratory 
Oversight Meeting with the accreditation organizations and States with 
CLIA-approved licensure programs to provide information on the approved 
program and enforcement responsibilities. CDC and CMS participated in 
numerous audio conferences with the cytology professional organizations 
to inform laboratories and individuals of the need to participate in 
the MIME program. CMS held national Open Door Forum teleconferences in 
January 2005 and March 2006 inviting all laboratories and the public to 
participate in discussions and ask questions about the requirements, 
and providing additional venues for CMS to further explain the 
mechanics of the PT process. CMS developed and continues to maintain a 
Web site, http://www.cms.hhs.gov/clia, containing information on PT, as 
well as a document for download titled ``Informational Supplement'' 
that is specific to cytology PT.
    In February 2005, the ASCP submitted an application for approval in 
2006. In March 2005, the CAP submitted its application for approval to 
provide PT for the 2006 testing cycle. The CAP program was approved 
September 1, 2005 for testing to begin in January 2006. The ASCP 
acquired the MIME program on February 26, 2006 and met the requirements 
for testing in 2006. Currently there are 3 CMS-approved gynecologic 
cytology PT programs; the MCPTP, ASCP, and CAP.
10. Opposition to Cytology PT
    In November 2004, CAP sent a letter to HHS requesting a 1 year 
moratorium on requiring individual enrollment in the MIME program. 
Following this letter, CDC and CMS met separately with CAP and the ASCP 
regarding the requested moratorium and their pending applications. At 
these meetings, the organizations also asked for expedited reviews of 
their PT program submissions to receive approval by January 1, 2005. 
Expedited reviews were granted; however, neither program met the 
requirements for approval under CLIA. The CAP application was 
subsequently revised, resubmitted, and approved by CMS to begin 
cytology PT in calendar year 2006.
    A coalition of State and national pathology societies submitted a 
letter in June 2005 asking the Secretary of HHS to re-evaluate the 
``relevance, validity, and ultimate effectiveness'' of cytology PT. The 
letter also suggested that if cytology PT were to be continued, it 
should be conducted on an educational basis. The letter called upon 
Congress to intervene and for HHS to thoroughly review the existing 
regulation.

E. Recent Congressional Actions

    On September 20, 2005, 103 Members of the United States House of 
Representatives sent a letter to the Secretary of HHS expressing 
concern about CMS' implementation of the 1992 requirements. The letter 
specifically addressed the absence of provisions addressing technology 
advancements made after the rule was written and suggested that the 
testing of individuals, as opposed to performance by the laboratory 
overall, was not based in statute but was devised by CMS in the 1992 
regulations. It also suggested that the imposition of Federal penalties 
on individuals supplanted the licensing authority of State governments. 
The letter requested that CMS suspend cytology PT until the regulations 
were revised.
    We carefully reviewed all the concerns raised about cytology PT in 
the letter from these Members of Congress and concluded that they did 
not warrant interruption of the ongoing testing of individuals required 
by statute. CMS (in its former status as the Health Care Financing 
Administration) and CDC had previously considered these issues and 
declined to make changes that we believed to be contrary to statutory 
requirements. However, we had modified the cytology PT requirements 
where possible, for example, reducing testing to once-per-year rather 
than multiple times per year. (See Sec.  493.855(a) of the CLIA final 
rule with comment published February 28, 1992).
    The contention that laboratories should be tested rather than 
individuals is contrary to the plain language of the statute, and 
therefore was not considered in the development of the cytology PT 
program and was subsequently ruled out by CLIAC in considering possible 
refinements to the program. In addition, findings from individual 
testing in the State of Maryland indicated that certain individuals and 
certain subgroups (for example, pathologists working without 
cytotechnologists) had higher rates of test failure that would probably 
not be identified if cytology laboratories were scored as a whole 
rather than scoring each individual as required by the statute and 
current regulations.
    We stated our intention to review the entire program after a full 
year's worth of national data were available and committed to working 
with the stakeholders and the CLIAC. We have fulfilled these 
commitments, giving rise to this proposed rule, as discussed in section 
II of the preamble.
    On November 9, 2005, in the 109th Congress, the Proficiency Testing 
Improvement Act of 2005 (H.R. 4268) was introduced in the House of 
Representatives. The legislation would have prohibited the Secretary of 
HHS

[[Page 3270]]

from conducting laboratory PT of individuals involved in screening or 
interpreting cytological preparations for 1 year and required the 
Secretary to revise the PT requirements before resuming the program in 
order to (1) reflect the collaborative clinical decision-making of 
laboratory personnel; (2) revise grading or scoring criteria to reflect 
current practice guidelines; (3) provide for testing to be conducted no 
more often than every 2 years; and (4) make other revisions as 
necessary to reflect changes in laboratory operations and practices 
since the original PT regulations were promulgated. This bill was 
referred to the House Committee on Energy and Commerce on November 9, 
2005 and to the Subcommittee on Health on November 22, 2005.
    On December 16, 2005, a second Proficiency Testing Improvement Act 
of 2005 (H.R. 4568) (identical to H.R. 4268) was introduced in the 
House of Representatives. This bill passed the House on December 17, 
2005 and was referred to the Senate Committee on Health, Education, 
Labor, and Pensions on January 27, 2006. The Senate took no action on 
this bill.
    On September 21, 2006, the Cytology Proficiency Improvement Act of 
2006 (H.R. 6133) was introduced in the House of Representatives. This 
bill required the Secretary of HHS to revise national quality assurance 
standards to include requirements for each clinical laboratory to (1) 
ensure that all individuals involved in screening and interpreting 
cytological preparations participate annually in an approved continuing 
medical education program in gynecologic cytology that provides each 
participant with gynecologic cytologic preparations designed to improve 
locator, recognition, and interpretive skills; and (2) maintain a 
record of such program results. The Secretary was also required to 
terminate the existing individual cytology PT program. This bill was 
referred to the House Committee on Energy and Commerce on September 21, 
2006 and to the Subcommittee on Health on October 2, 2006.
    On November 15, 2006, an identical bill to H.R. 6133 was introduced 
in the Senate (S. 4056), and was referred to the Senate Committee on 
Health, Education, Labor, and Pensions.
    In December 2006 the 109th Congressional session came to an end 
with no action taken on H.R. 6133 or S. 4056.
    In the 110th Congress, the Cytology Proficiency Improvement Act of 
2007 (H.R. 1237) was introduced in the House of Representatives on 
February 28, 2007, and was referred to the House Committee on Energy 
and Commerce on that date, and to the Subcommittee on Health on March 
1, 2007. This bill was identical to H.R. 6133 from the 109th Congress.
    A Senate version of the Cytology Proficiency Improvement Act of 
2007 (S. 2510) was introduced on December 18, 2007. While very similar 
to H.R. 1237, this bill included some additional requirements for how 
the results of an individual's participation in continuing medical 
education would be used. S. 2510 was referred to the Senate Committee 
on Health, Education, Labor, and Pensions.
    H.R. 1237 was subsequently amended to be identical to S. 2510 and 
was passed by the House of Representatives on April 8, 2008.
    In December 2008 the 110th Congress ended with the Senate having 
taken no action on S. 2510.

II. Rationale for Proposed Rule

    CLIA regulations for cytology PT were published in 1992 and 
implemented in Maryland in January 1995 following approval of the 
Maryland Cytology Proficiency Testing Program (MCPTP). The first 
program approved for nationwide cytology PT was the MIME program in 
2005.
    To address the numerous concerns voiced about cytology PT 
implementation, the CMS presented a status report on cytology PT 
implementation during the CLIAC meeting in February 2005 and described 
the Cytology Personnel Records System (CYPERS). CYPERS was developed 
and implemented by us to maintain the confidentiality of an 
individual's enrollment, participation, and PT scores, and to allow us 
to monitor individual performance in cytology PT. The notice for the 
new Privacy Act System of Records, CYPERS, was published in the Federal 
Register on January 14, 2005 (70 FR 2637). Also at the February 2005 
CLIAC meeting, public comments opposing the implementation of cytology 
PT through the MIME program were presented by the ASC and ASCP, 
highlighting their concerns which included, (1) perceived problems with 
the scoring scheme and validation of slides; and (2) the regulations' 
failure to consider the semi-automated technology used in current 
practice. CLIAC recommended consideration be given to revising the 
cytology PT regulations ``based on current practice, evidence-based 
guidelines and anticipated changes in technology'' as reflected in 
updated comments from the professional organizations and the public. 
(These recommendations and proposed revisions are documented on the 
CLIAC Web site at http://www.cdc.gov/cliac/cliac0205.aspx, summarizing 
the February 2005 CLIAC meeting).
    In September 2005, CLIAC recommended formation of a cytology PT 
workgroup to consider potential changes to the regulations. In 
addition, comments and data were solicited from professional 
organizations on the potential impact of any proposed regulatory 
revisions on laboratories, cytology PT programs, and the cytology 
workforce.
    In November 2005, CDC and CMS staff met with the Cytology Education 
and Technology Consortium (CETC) to solicit suggestions from the 
professional organizations represented in the consortium (ASCP, CAP, 
International Academy of Cytology (IAC), ASC, ASCT and the Papanicolaou 
Society of Cytopathology (PSCO)) and their members for recommendations 
for specific changes to the regulations. Following this meeting, the 
CETC and the ASCT provided comments identifying potential issues to be 
considered for regulatory revisions. The comments provided by the CETC 
were endorsed by all member organizations with the exception of CAP. 
The issues identified included: Testing the individual compared to 
testing the laboratory; impact of new technology; frequency of testing; 
number of challenges per testing event; categories of challenges; 
grading scheme point values; validation of challenges; remediation for 
failure; testing site; and confidentiality.
    At the February 2006 CLIAC meeting, CMS provided preliminary data 
on the status of 2005 cytology PT results. CDC provided information on 
the process for revising the regulations and announced the formation of 
a cytology PT workgroup. The purpose of the workgroup, which was 
comprised of practicing pathologists and cytotechnologists, was to 
develop suggestions for proposed revisions to the cytology PT 
regulations and to present their findings to CLIAC for consideration in 
making recommendations to HHS for revisions to the regulations.
    In March 2006, the cytology PT workgroup met for 2 days to develop 
suggestions for proposed revisions to the cytology PT regulations. 
These suggestions included: Using the term ``challenges'' instead of 
``slides'' to accommodate other testing media; defining challenges as 
case equivalent (glass slides, virtual slides, or other approved 
media); reducing the frequency of testing; increasing the

[[Page 3271]]

number of challenges per testing event; requiring field validation of 
challenges with disclosure of the validation process to participants by 
the PT program; and changing the scoring scheme for pathologists and 
cytotechnologists to eliminate the automatic failure for misdiagnosis 
of a HSIL or cancer (Category D).
    At a June 2006 CLIAC meeting, CLIAC reviewed the suggestions for 
regulatory revisions proposed by the workgroup. The CLIAC made the 
following recommendations: (1) Use the preamble to encourage 
laboratories to participate in educational laboratory programs in 
addition to individual proficiency testing; (2) require oversight 
organizations/agencies and surveyors to determine if laboratories 
participate in educational programs and provide laboratories with 
identification of available resources; (3) change the term ``slides'' 
to ``challenges'' to allow for the use of virtual slides; (4) define a 
challenge as a case equivalent-glass slide, virtual slide, or other 
approved media; (5) add a requirement for a transition phase for all 
new technology (for example, virtual slides), and to allow the 
individual to request retesting with glass slides; (6) reduce the 
frequency of testing to a 3-year test cycle using 20 challenges for 
every test (initial and retest); (7) retain four diagnostic categories 
and continue to require at least one challenge from each of the four 
categories; (8) change language to state ``individuals who score <90 
percent'' (as opposed to ``who fail''); and (9) change the grading 
scheme to a unified model for both cytotechnologists and pathologists 
and eliminate automatic failures for misdiagnosis of one HSIL or cancer 
(Category D). The following grading scheme was recommended by the 
CLIAC:

                                         Model X-20 Slide Test--Unified
----------------------------------------------------------------------------------------------------------------
                                                                              Examinee response
                      Correct response                      ----------------------------------------------------
                                                               A--UNSAT    B--NEGATIVE    C--LSIL      D--HSIL
----------------------------------------------------------------------------------------------------------------
A--UNSAT...................................................           5              0            0            0
B--NEGATIVE................................................           2.5            5            0            0
C--LSIL....................................................           0              0            5            5
D--HSIL....................................................           0             -5            5            5
----------------------------------------------------------------------------------------------------------------

    CLIAC also made recommendations for PT programs, including the 
following: (1) Require biopsy confirmation of HSIL or cancer (Category 
D) challenges, but not LSIL (Category C) challenges; (2) require field 
validation, monitor challenges continuously, and remove challenges that 
fail field validation; (3) require validation procedures to be 
disclosed by the PT program; (4) allow the PT programs to determine 
alternate options for test sites for missed tests (that is, excused 
absences and retesting) (they noted that the preamble could be used to 
encourage more options for test sites); (5) allow the PT programs to 
determine the proctor requirements; (6) provide more specific 
educational feedback on result discrepancies; and (7) require PT 
programs to disclose the appeal process in writing. A summary of this 
meeting is found at http://www.cdc.gov/cliac/.
    CDC and CMS met with the 3 approved cytology PT programs on August 
28, 2006 to solicit input on operational issues. Issues discussed 
included: Quality assurance of the testing process; proctor 
requirements; testing sites; validation of testing materials; biopsy 
confirmation of HSIL or cancer (Category D) and LSIL (Category C); 
comparable test sets; and administrative issues. In addition, programs 
were asked to provide data for the impact analysis.
    Listed below is a chronology of events related to the 
implementation of cytology PT:

             Chronology of Events--Implementing Cytology PT
------------------------------------------------------------------------
 
------------------------------------------------------------------------
October 1988..............................  The Clinical Laboratory
                                             Improvement Amendments
                                             (CLIA) were enacted,
                                             amending the Public Health
                                             Service Act.
May 1990..................................  CMS published a CLIA
                                             proposed rule.
February 1992.............................  CDC and CMS published a CLIA
                                             final rule with comment
                                             period.
January 1993..............................  Consumer Federation of
                                             America and Public Citizen
                                             filed a lawsuit challenging
                                             the timeframe for cytology
                                             PT.
January 1993..............................  State of Maryland Cytology
                                             PT Program submitted an
                                             application for approval.
March 1993................................  CDC published a request for
                                             proposal to obtain
                                             referenced Pap smear glass
                                             slides for a national
                                             cytology PT program.
November 1993.............................  CDC, CMS, and cytology
                                             organizations co-hosted
                                             ``Cytology PT Symposium''
                                             to discuss alternatives to
                                             glass slide testing.
November 1993.............................  State of Wisconsin submitted
                                             an application for cytology
                                             PT program approval.
December 1993.............................  The CLIAC made
                                             recommendations concerning
                                             cytology PT.
May 1994..................................  CMS approved the Maryland
                                             and Wisconsin State PT
                                             programs for testing in
                                             1995. The Maryland State PT
                                             program has been reapproved
                                             annually since 1995.
September 1994............................  CDC awarded three
                                             cooperative agreements for
                                             development of prototype
                                             computer-based cytology PT
                                             programs.
October 1994..............................  State of Wisconsin
                                             terminated its program
                                             prior to implementation.
December 1994.............................  CDC and CMS published a rule
                                             extending the cytology PT
                                             enrollment date.
January 1995..............................  CDC awarded a contract to
                                             compare glass slide PT and
                                             computer-based PT to
                                             workplace performance.
April 1995................................  CDC and the cooperative
                                             agreement awardees pilot
                                             tested the three cytology
                                             CBPT prototypes at national
                                             cytology meetings.
November 1995.............................  CDC and CMS published a
                                             proposed rule to change the
                                             timeframe allowed for
                                             cytology PT testing based
                                             on a court order from the
                                             Consumer Federation of
                                             America and Public Citizen
                                             v. HHS, lawsuit (906
                                             F.Supp., 657 (D. D.C.
                                             1995).
October 1996..............................  CDC developed a computer-
                                             based prototype called
                                             CytoView\TM\ to test
                                             locator and interpretive
                                             skills.
March 1997................................  CAP submitted an application
                                             for cytology PT program
                                             approval.
June 1999.................................  CDC developed CytoView\TM\
                                             II.

[[Page 3272]]

 
March 2000................................  CDC and CMS withdrew the
                                             1995 proposed rule and
                                             reinstated the 1992 PT
                                             timeframes pursuant to
                                             ruling by the appellate
                                             court.
July 2002.................................  CDC and the State of
                                             Maryland completed a study
                                             comparing individual
                                             performance on glass slide
                                             PT and CytoView\TM\ II.
March 2004................................  Midwest Institute for
                                             Medical Education (MIME)
                                             submitted an application
                                             for cytology PT program
                                             approval.
September 2004............................  CMS approved the MIME
                                             program to initiate testing
                                             in 2005.
November 2004.............................  CAP requested a one year
                                             moratorium on the
                                             requirement to participate
                                             in cytology PT.
November 2004.............................  CAP withdrew its application
                                             for program approval.
January 2005..............................  CMS held an Open Door Forum
                                             to inform laboratories of
                                             the first approved national
                                             cytology PT program and
                                             respond to questions.
January 2005..............................  CMS published a notice
                                             announcing a new System of
                                             Records, CYPERS.
February 2005.............................  CMS held a Partners In
                                             Laboratory Oversight
                                             Meeting with accreditation
                                             organizations and States
                                             with CLIA-approved
                                             licensure programs to
                                             inform them of the
                                             requirement for all
                                             laboratories performing
                                             gynecologic cytology to
                                             participate in cytology PT.
February 2005.............................  CMS presented details of the
                                             PT requirements for
                                             cytology laboratories to
                                             the CLIAC. The CLIAC
                                             recommended revisions be
                                             made to the regulations.
February 2005.............................  ASCP submitted an
                                             application for cytology PT
                                             program approval.
February 2005.............................  MIME initiated testing of
                                             cytology laboratories.
March 2005................................  CAP submitted a new
                                             application for cytology PT
                                             program approval.
June 2005.................................  CAP sent a letter signed by
                                             State and national
                                             organizations to HHS
                                             expressing concern about
                                             cytology PT implementation.
                                             Response sent August 2005.
June 2005.................................  ASCP submitted a new
                                             application for cytology PT
                                             program approval.
August 2005...............................  State of Maryland and MIME
                                             cytology PT programs were
                                             reapproved for testing in
                                             2006.
September 2005............................  CAP program was approved to
                                             initiate cytology PT in
                                             2006.
September 2005............................  CLIAC recommended convening
                                             a cytology PT workgroup to
                                             consider potential changes
                                             to the cytology PT
                                             requirements.
September 2005............................  Some Members of the House of
                                             Representatives sent a
                                             letter to HHS expressing
                                             concern about
                                             implementation of the
                                             cytology PT regulation.
November 2005.............................  At the CETC meeting,
                                             preliminary 2005 cytology
                                             PT results were presented
                                             and organizations were
                                             invited to submit
                                             suggestions for changes to
                                             revise the cytology PT
                                             regulation.
November 2005.............................  H.R.* 4268 introduced--would
                                             have suspended cytology PT
                                             for one year.
December 2005.............................  House of Representatives
                                             passed H.R. 4568 (identical
                                             to H.R. 4268) and sent it
                                             to the Senate.
January 2006..............................  H.R. 4568 referred to Senate
                                             Health, Education, Labor
                                             and Pensions (HELP)
                                             Committee for
                                             consideration.
February 2006.............................  ASCP acquired the MIME
                                             program.
February 2006.............................  CDC announced the CLIAC
                                             Cytology PT workgroup would
                                             meet in March 2006.
March 2006................................  CLIAC Cytology PT workgroup
                                             met.
March 2006................................  CMS held a second Open Door
                                             Forum to respond to
                                             questions about
                                             implementation of cytology
                                             PT.
June 2006.................................  Workgroup recommendations
                                             were reported to the CLIAC,
                                             which considered the
                                             recommendations and made
                                             its own recommendations to
                                             HHS for revisions to
                                             cytology PT requirements.
August 2006...............................  CDC and CMS met with PT
                                             program representatives to
                                             solicit comments on the
                                             administration and
                                             operation of cytology PT.
September 2006............................  H.R. 6133 introduced--
                                             required the Secretary to
                                             terminate PT and replace
                                             with continuing medical
                                             education requirement.
November 2006.............................  S.** 4056 introduced
                                             (identical to H.R. 6133).
December 2006.............................  109th Congressional session
                                             ended without enactment of
                                             any cytology PT bill.
December 2006.............................  State of Maryland, ASCP, and
                                             CAP cytology PT programs
                                             were reapproved for testing
                                             in 2007.
February 2007.............................  H.R. 1237 introduced
                                             (identical to H.R. 6133).
                                             This bill was referred to
                                             the House Committee on
                                             Energy and Commerce,
                                             Subcommittee on Health.
December 2007.............................  S. 2510 introduced (similar
                                             to H.R. 1237). This bill
                                             was referred to the Senate
                                             Committee on Health,
                                             Education, Labor, and
                                             Pensions (HELP).
April 2008................................  H.R. 1237 amended (so
                                             identical to S. 2510) and
                                             passed by the House of
                                             Representatives--would
                                             terminate cytology PT and
                                             replace it with continuing
                                             medical education
                                             requirement.
December 2008.............................  110th Congressional session
                                             ended without enactment of
                                             any cytology PT bill.
------------------------------------------------------------------------
Note to Reader:
\*\ H.R.  means a bill introduced in
  the United States House of Representatives.
\**\ S.  means a bill introduced in
  the United States Senate.

III. Provisions of the Proposed Regulations

    This section provides an overview of the proposed revisions to the 
CLIA requirements for gynecologic cytology PT specified in Subpart A-- 
General Provisions, Sec.  493.2 Definitions; Subpart H-- Participation 
in Proficiency Testing for Laboratories Performing Nonwaived Testing, 
Sec.  493.803 Condition: Successful participation; Subpart I-- 
Proficiency Testing Programs for Nonwaived Testing, Sec.  493.905 
Nonapproved proficiency testing programs, and Sec.  493.945 Cytology; 
gynecologic examinations, established by the February 28, 1992 final 
rule with comment.
    In addition, since the specialty of pathology includes, for 
purposes of proficiency testing, only gynecologic examinations within 
the subspecialty of cytology, we are proposing to replace the 
Condition: Pathology at Sec.  493.853 with the new Condition: Cytology: 
gynecologic specimen examinations at Sec.  493.853. We are proposing to 
remove and reserve Sec.  493.855 Standard; Cytology: gynecologic 
examinations. The requirements currently at Sec.  493.855 will be moved 
to a new condition section (that is, Sec.  493.853 Condition: Cytology: 
gynecologic specimen examinations). We are proposing this change 
because no proficiency testing is required for histopathology (the 
other subspecialty in pathology). This change is needed to change 
cytology proficiency testing from a standard to a condition or we would 
be unable to limit the certificate in such a way as to

[[Page 3273]]

address cytology alone as opposed to all of pathology. We believe that 
if we do not propose this change, it could lead to the unintended 
consequence of taking an enforcement action in other subspecialties of 
pathology where problems do not necessarily exist.
    We are soliciting specific comments on these proposed changes. The 
proposed revisions are based on our experience with the current 
cytology PT requirements, CLIAC recommendations made in June 2006, 
input from cytology PT programs, and comments solicited from the 
cytology organizations.

A. Cytology Challenges and New Technology

    The requirements currently at Sec.  493.855(b) specify that 
individuals be tested using glass slides, which was the standard of 
practice when the February 28, 1992 final rule with comment was 
published. Following the 1992 publication, semi-automated screening 
(computer-assisted and location-guided instruments) was developed for 
the evaluation of cytology preparations on glass slides. In March 2006, 
the CETC indicated that an increasing number of laboratories are 
routinely using newer technology to replace the traditional manual 
screening of conventional Pap smears, and stated that testing these 
laboratories in the manner described in the February 28, 1992 final 
rule with comment is inconsistent with the statutory language requiring 
testing of individuals ``under normal working conditions.'' The CETC 
further stated that the proposed PT requirements should accommodate 
technology currently in use in laboratories, and should be flexible 
enough to accommodate any technologies that might be used in the 
future, such as digital imaging. The ASCT suggested that PT options 
should be available for those individuals using semi-automated 
technology if requested, as well as glass slide challenges for manual 
examination.
    The CLIAC recommended changing the regulatory language of 
``slides'' to ``challenges.'' Several CLIAC members commented that the 
use of the term ``challenges'' would allow flexibility to PT programs 
transitioning from manual testing to newer technology and to 
individuals in selecting the testing media with which they are most 
familiar for examining patient specimens. The CLIAC subcommittee in 
their June 2006 meeting also recommended a phase-in period, including 
pilot testing, be required for programs that initiate testing using new 
technology.
    Based on this input and to allow more flexibility, we are proposing 
to change the terminology ``glass slides'' to ``cytology challenges'' 
to allow for the approval of programs that use glass slides as well as 
semi-automated screening protocols, digital images, or other testing 
media in the future. In this rule, we are proposing at Sec.  493.2 to 
revise the definition for ``challenge'' and add the definition 
``cytology challenge'' which we propose will mean ``a sample consisting 
of gynecologic cytology material that is used to evaluate the 
individual's locator and identification skills. Cytology challenge 
material may include glass slides, digital images, or other CMS 
approved testing media.'' Presently, CMS is considering requiring 
programs to pilot test any new testing media and submit their data in 
their next application for approval. We are soliciting comments on the 
contents of this proposed rule, specifically:
     Is the proposed definition for ``cytology challenge'' 
appropriate to address future technological advances?
     Should criteria be included in the regulations for pilot 
testing before CMS approval of any new cytology testing media? If so, 
please specify the appropriate criteria.
     Should pilot testing include a comparison to current 
technology? What is an acceptable comparison?
     If specific criteria for pilot testing are required, what 
burden would be incurred by PT programs and laboratories participating 
in a pilot test?
     Would requiring pilot testing cause an increase in the 
cost of cytology PT?

B. Testing Individuals

    The requirements in the February 28, 1992 final rule with comment 
reflected the provision in the CLIA statute at section 353(f)(4)(B)(iv) 
of the Public Health Service Act requiring ``periodic confirmation and 
evaluation of the proficiency of individuals involved in screening or 
interpreting cytological preparations, including announced and 
unannounced on-site testing of individuals, with testing to take place, 
to the extent practicable, under normal working conditions''. The CETC 
commented that the provision requiring testing of individual 
cytotechnologists and pathologists was the most troubling aspect of the 
statute. The CETC suggested that testing the laboratory as a whole, as 
is the case with non-cytology PT, would be a better approach for 
assuring the quality of laboratory results. The CETC suggested 
enrolling each laboratory on an annual basis with no formal enrollment 
of individuals, noting that individuals would be periodically tested 
through participation in laboratory PT.
    Several CLIAC members suggested an approach to PT that would be 
consistent with the presentation made by the CAP during the meeting's 
public comment period. CAP suggested during the public comment period 
that cytology PT be modified to make it more consistent with the 
regulatory approach of the Mammography Quality Standards Act (MQSA). 
The CAP also suggested that the impetus for the MQSA was similar to 
CLIA because of similar quality-of-care concerns for diagnostic 
screening services and the same regulatory objective to reduce false 
negative rates. The Food and Drug Administration (FDA) does not agree 
with the CAP's additional assertion that, in implementing the 
mammography standards under MQSA, the FDA rejected PT as an assessment 
tool due to the lack of consensus on testing standards and 
measurements. FDA does agree that it instead focused on assessing the 
competency of the facility by evaluating outcomes produced by the 
facility. CAP requested that HHS consider an approach similar to the 
MQSA that would incorporate laboratory outcomes assessments and use 
other outcome measures, for example evaluation of laboratory QC and 
review of previously evaluated cases. While this approach for 
evaluating laboratory performance may have merit, it would require 
Congress to change CLIA to eliminate the requirement for the evaluation 
of an individual's proficiency. As such this cannot be addressed 
through rulemaking, and only changes to individual testing are included 
in this proposed rule. Through inspections that evaluate laboratory 
quality control (QC) and the rescreening of a sample of slides 
previously examined by the laboratory's cytotechnologists and 
pathologists, CMS has continued to identify serious problems, including 
significant misdiagnoses. These findings appear to demonstrate the need 
for continued PT of individuals.
    The CLIAC noted that CAP, as an accreditation organization for many 
cytology laboratories, currently requires its accredited laboratories 
to participate in an educational peer comparison program in gynecologic 
cytology in addition to the required individual participation in 
cytology PT. CLIAC recommended that laboratories be strongly encouraged 
to participate in educational programs. While not required under CLIA, 
CMS has always encouraged laboratory participation in educational 
programs in gynecologic cytology as well as participation in

[[Page 3274]]

individual PT. The CLIAC recommended that oversight organizations and 
agencies, as part of their inspection process, determine whether 
laboratories participate in educational programs and for those not 
participating, assist in identifying available educational programs. 
CMS anticipates adding this recommendation to Appendix C of the State 
Operations Manual (CMS Pub. 7).
    We are soliciting comments on the following:
     Should enrollment and participation in an educational 
program be required for all cytology laboratories? If so, how would 
this enrollment be monitored by CMS?
     If enrollment and participation in educational programs 
were to be required, what criteria would be appropriate for CMS to 
adopt through rulemaking to evaluate these programs?
     If enrollment and participation in educational programs 
were to be required, how might CMS monitor or evaluate an individual's 
participation in such a program?
     If educational programs were required, what enforcement 
actions might be appropriate for laboratories if laboratories/
individuals did not participate in the required programs?

C. Frequency of Testing

    The requirements currently at Sec.  493.855(a), specify that 
laboratories must ensure that each individual engaged in the 
examination of gynecologic preparations participates in cytology PT at 
least once a year. Comments received from the CETC and ASCT stated that 
annual testing is excessive since there is no evidence that cytology 
screening and interpretive skills deteriorate after 1 year. The CETC 
further explained that cytology PT of individuals is not analogous to 
clinical laboratory PT which is dependent on instrument calibration and 
reagents that can vary by lot number. The CETC suggested the interval 
between testing events be lengthened to 5 years for well-trained 
cytology professionals, who assess cervical cytology preparations on a 
regular basis. The ASCT indicated that other safeguards are in place in 
cytology, for example, the biennial inspection of laboratories, and the 
requirements for 10 percent random rescreening of all negative 
specimens, correlation between cytology and histopathology reports, if 
available, and retrospective review of all negative specimens from the 
previous 5 years when a current HSIL or cancer (Category D) is 
identified. The ASCT suggested the testing interval for individuals be 
every 3 years.
    At the June 2006 CLIAC meeting, The New York State Department of 
Health Cytology PT Program presented performance data, which revealed 
that individual failure rates plateaued over time and did not tend to 
increase after switching from annual to biennial testing. Frequencies 
other than every 2 to 3 years were also discussed. However, a concern 
was expressed that less frequent testing may allow poor performers to 
go undetected, thus jeopardizing the quality of Pap smear testing. 
After deliberations, the CLIAC recommended testing of individuals every 
3 years.
    In an effort to balance the quality concerns with the desire to 
reduce the testing burden, we are proposing at Sec.  493.945(a) and (b) 
to reduce the frequency for gynecologic cytology testing from annual to 
every 2 years and increase the number of cytology challenges from 10 to 
20 per testing event.
    Comments are being solicited on the following questions which must 
be considered with the proposed grading changes that follow:
     How many cytology challenges per test event are 
appropriate to assess individual performance?
     Should annual testing continue to be required with 10 
slides per test?
     Is 2 years an appropriate testing interval using 20 slides 
per test?
     Why would a testing frequency longer than every 2 years be 
appropriate?
     If an individual is allowed to pass a 20 cytology 
challenge test when an HSIL or cancer (Category D) cytology challenge 
is reported as Normal or Benign Changes (Category B), how long should 
the timeframe be between testing events?
     What type of data should be collected to determine if a 
longer interval between testing is appropriate? Who should collect the 
data? How long should the data be collected?
     What types of data are needed to validate testing less 
frequent than annually?

D. Number of Cytology Challenges

    As currently specified at Sec.  493.855(b), each individual is 
required to be tested with 10 glass-slide challenges. If a score of at 
least 90 percent is not achieved, an individual has not successfully 
completed the test and must be retested with an additional 10 glass 
slide test set. If the individual does not achieve at least 90 percent 
on the retest, each subsequent retest must include 20 glass slide 
challenges. The ASCT questioned whether a 10 slide test has the ability 
to accurately assess proficiency. However, the ASCT acknowledged that 
the increased time and cost required to administer a 20 challenge test 
might not be justified. The ASCT also noted that the requirement to 
include at least one challenge from each of the four response 
categories in a 10 challenge test set might be more a measure of 
mathematical and statistical skill used to ``game'' the system rather 
than a demonstration of diagnostic skill.
    The New York State Department of Health Cytology PT Program 
provided data at the June 2006 CLIAC meeting supporting the premise 
that a 10 challenge test lacked the discriminatory power to 
differentiate between competent and incompetent examinees. The New York 
representative stated that a competent examinee failing a testing event 
is a lesser problem than an incompetent individual passing the event 
because of the high probability that the competent individual would 
pass the second test. An incompetent individual passing the testing 
event is a more serious problem as the individual could continue to 
examine patient specimens until the next testing cycle. New York used 
statistical examples to demonstrate how a larger sample size would 
increase the reliability and precision for identifying poor performers 
while not failing good performers. New York proposed that a more 
accurate assessment of proficiency would be an initial test consisting 
of 40 to 60 challenges followed by PT at 5 to 10 year intervals.
    During discussion at the June 2006 CLIAC meeting, it was noted that 
a 10 slide test containing one challenge from each response category 
would allow an individual to make an educated guess through the process 
of elimination by selecting response categories that would result in 
the fewest lost points. Increasing the number of challenges to 20 would 
make it harder to ``game'' the test even with the requirement to 
include at least one challenge from each of the four response 
categories. In order to increase the discriminatory power of the 
testing event and decrease the opportunities for ``gaming,'' the CLIAC 
recommended 20 challenges for all testing events.
    After considering these comments, we are proposing at Sec.  
493.945(b) that a minimum of 20 cytology challenges would be required 
for each testing event. In general, increasing the number of challenges 
in any test increases the statistical power to discriminate between 
truly incompetent and competent performers. We considered increasing 
the number of challenges to more than 20; however this would add 
additional costs and burden with no

[[Page 3275]]

established benefit. The calculation of statistical power is not 
straightforward for a test of this type, which is impacted by variables 
inherent in the population of examinees, the composition of the slide 
sets and the non-dichotomous scoring scheme. For these reasons, as well 
as the lack of actual performance data, it was not possible to 
calculate actual statistical power to compare the current and proposed 
number of challenges. However, according to Nagy and Collins (35 Acta 
Cytologica, 3-7, 1991), increasing the number of challenges from 10 to 
20 will reduce the statistical probability that an individual who is 
not proficient will pass and will not substantially change the 
probability that a competent individual will fail. This conclusion was 
based on probability theory, a simple statistical binomial error model 
and the assumption that a competent cytologist routinely performs at 90 
percent proficiency. A competent individual not passing the first test 
is a lesser problem, because of the high probability the individual 
would pass on the second test. Increasing the number of challenges can 
also minimize the probability of misclassifying a proficient performer 
as not proficient. No test is 100 percent sensitive and specific; 
therefore, for statistical reasons, some competent cytologists will not 
pass an individual test and, conversely, some who are not proficient 
will pass. As noted by Gifford, Green and Coleman (8 Cytopathology, 96-
102, 1997) even competent performers will occasionally obtain a score 
of less than 90 percent and be subject to a retest.
    In addition, statistical calculations can not take into account 
other factors such as test familiarity. Examinees become familiar with 
test formats and the testing process, and thus experienced examinees 
will have a better chance at passing than those taking the test for the 
first time (Nagy and Collins, 35 Acta Cytologica, 3-7, 1991). This has 
been demonstrated in the State programs in which pass rates have 
increased over time (Newton L.E., Cytopathology Proficiency Testing in 
New York State: the First 25 Years. 25(4) Laboratory Medicine: 230-
231(1994) and Keller, B., information presented to CLIAC, June 20-21, 
2006, http://wwwn.cdc.gov/cliac/default.aspx, Addendum H).
    We are proposing to retain the requirement to include at least one 
cytology challenge from each of the four response categories. We are 
proposing to add the requirement that each testing event include two 
cytology challenges from the response Category ``D'' that includes HSIL 
or cancer. By requiring at least 2 high grade lesion or cancer 
challenges per test of 20 challenges, the test difficulty will be 
similar to that of the current test in which 1 high grade lesion or 
cancer challenge is required per 10 slide test. This will (1) ensure an 
evaluation of the ability to differentiate more severe lesions from 
less severe lesions; (2) evaluate major false negative calls (inability 
to distinguish a high grade lesion or cancer challenge from a normal 
challenge) on the basis of more than one challenge; and (3) promote 
equivalence among test sets and among PT programs (if only 1 high grade 
lesion or cancer challenge was required, some programs may only include 
1 such challenge to make their test easier than a program that included 
1 or more high grade lesion or cancer challenges). We are also 
maintaining the 4 hour time period for a 20 cytology challenge test, 45 
day timeframe for retests, remedial action requirements for scoring 
less than 90 percent, mandatory rescreening, and cessation of the 
examination of patient specimens after a third score of less than 90 
percent on the second retest (third test).
    We are soliciting comments on the effects of these proposals on 
laboratories and individuals as follows:
     Are there logistical concerns and costs associated with 
administering testing events with more than 20 cytology challenges?
     If 20 cytology challenges are used, thereby requiring a 4 
hour timeframe to administer the test, what would be the impact on the 
laboratory operation?
     Would laboratories prefer a 4 hour testing timeframe 
biennially, rather than the current 2 hour testing timeframe annually?
     Should there be a requirement for each test set to contain 
at least one cytology challenge from each of the four response 
categories or more than one cytology challenge from each response 
category?
    We are also soliciting comments on the effects of these proposals 
on PT programs as follows:
     Are there a sufficient number of referenced cytology 
challenges available to assemble 20 cytology challenge test sets to 
test all cytology personnel nationally?
     Would increasing the number of cytology challenges 
increase the PT program's cost to administer the program?
     Would program costs to participants increase from a 10 
slide annual test to a 20 cytology challenge biennial test?
     What statistical methods and testing research could CMS 
use to better determine the statistical power of a cytology proficiency 
test with 20 challenges and a multinomial, weighted scoring scheme?

E. Response Categories

    The response categories described at Sec.  493.945(b)(1) include: 
Unsatisfactory (Category A); normal or benign changes (Category B); low 
grade squamous intraepithelial lesions (LSIL)(Category C); and high 
grade squamous intraepithelial lesions (HSIL) or cancer (Category D). 
These response categories minimize the number of choices an individual 
can make during a testing event while retaining the general diagnostic 
categories used by most laboratories.
    The CETC stated that while Bethesda 2001 terminology requires 
distinct interpretation of LSIL (Category C) and HSIL or cancer 
(Category D), the separation of these squamous abnormalities is not 
always an exact science and under the patient management guidelines of 
the American Society for Colposcopy and Cervical Pathology (ASCCP) both 
are referred for colposcopy. The CETC suggested only a small number of 
points be lost for failing to make this distinction. The ASCT suggested 
combining HSIL or cancer (Category D) and LSIL (Category C) to reflect 
the cytotechnologist practice of categorizing Pap smear diagnoses using 
three distinctions: Unsatisfactory, negative or normal, and ``refer to 
the pathologists.''
    The CETC noted there were several concerns with the unsatisfactory 
category because studies have shown, even with obvious cases, it is 
difficult to achieve a consensus diagnosis with this response category. 
The ASCT suggested omitting the unsatisfactory category and eliminating 
the mandate to require at least one unsatisfactory slide in each test 
set. The ASCT stated that the 1992 description of unsatisfactory 
challenges is outdated and subjective, specifically the description of 
unsatisfactory challenges as those with scant cellularity, air drying, 
or obscuring material would not apply to liquid-based preparations; 
instead they suggested that the description for unsatisfactory included 
in the regulations should follow the less descriptive Bethesda 2001 
terminology. Use of the Bethesda 2001 terminology would serve a dual 
purpose of not limiting programs that use different technology, for 
example semi-automated screening programs, and not restricting the 
specific criteria for unsatisfactory to the current preparation types.
    To maintain the diagnostic categories used by most laboratories in 
reporting patient results, CLIAC recommended

[[Page 3276]]

retaining the four response categories. We agree with the CLIAC 
recommendation and are proposing to maintain the current four response 
categories: Unsatisfactory (Category A); Normal or Benign changes 
(Category B); LSIL (Category C); and HSIL or cancer (Category D).
    While no change is proposed for the number of response categories, 
we are proposing at Sec.  493.945, to change the description of the 
unsatisfactory category to reflect Bethesda 2001 terminology which 
states the specimen is processed and evaluated but unsatisfactory for 
evaluation of epithelial abnormality. All CMS approved cytology PT 
programs would be required to define the specific criteria used to 
describe the unsatisfactory response category.
    We are soliciting comments on the following:
     Should criteria be defined in the regulation for 
``unsatisfactory'' cytology challenges?
     If criteria for ``unsatisfactory'' are described, should 
the regulations include descriptions or criteria specific to each 
preparation type?
     Should a fifth response category be required, separating 
HSIL or cancer (Category D) to more closely follow Bethesda 
terminology? We note that Bethesda 2001 separates LSIL (Category C) 
from HSIL (Category D), and separates HSIL from cancer, also (Category 
D).
     If a fifth category of cancer is required, should an 
individual who has an incorrect response in this category be allowed to 
pass PT?

F. Cytology Challenge Referencing

    The requirements currently at Sec.  493.945(b)(1), specifies 
referencing each glass-slide challenge with 100 percent consensus by a 
minimum of three physicians certified in anatomic pathology. ASCT 
suggested referencing of the challenges include blind review by three 
cytopathologists on undotted slides; however, the organization also 
stressed the importance of including cytotechnologists in the review 
process, as this reflects the current practice of using a 
cytotechnologist as the initial screener and evaluator. A PT program 
recommended requiring each physician certified in anatomic pathology to 
independently review each challenge. CLIAC discussed these options but 
did not make a recommendation on changing the process for referencing 
the challenges.
    CMS would encourage PT programs to use blind review or other 
mechanisms to ensure each cytology challenge is referenced in the 
correct category. In this proposed rule, we are proposing at Sec.  
493.945(c)(1)(i), to retain the requirement for 100 percent consensus 
by a minimum of three physicians certified in anatomic pathology. 
However, based on our experience, we are also proposing that each 
physician who references cytology challenges must examine gynecologic 
preparations on a routine basis.
    We are soliciting comments on the following:
     Should the review of cytology challenges by three 
physicians certified in anatomic pathology be on undotted slides?
     Should the three physicians certified in anatomic 
pathology independently determine the response category for each 
cytology challenge?
     Should PT programs be required to include 
cytotechnologists in the review process for referencing cytology 
challenges? If so, describe a process for including cytotechnologists.

G. Biopsy Confirmation

    The requirements currently at Sec.  493.945(b)(1), specify biopsy 
confirmation of premalignant and malignant challenges. Consequently, PT 
programs need to obtain sufficient numbers of slides that meet the 
diagnostic criteria for these categories and have confirmatory 
histology. This requirement has resulted in the removal of potential PT 
challenges when sampling techniques fail to obtain diagnostic tissue or 
tissue samples are not consistent with the cytology diagnosis. It was 
stated at the June 2006 CLIAC meeting that while LSIL (Category C) is 
reproducible, there are instances of cytologic LSIL (Category C) that 
do not confirm by colposcopy. LSIL (Category C) lesions are often 
transient and may regress in the interval between the time the Pap 
smear is taken and the time of colposcopic biopsy. The CLIAC 
recommended removal of the requirement for biopsy confirmation of LSIL 
(Category C) challenges while retaining it for HSIL or cancer (Category 
D).
    Based on the CLIAC recommendations and PT program comments, we are 
proposing to eliminate the requirement for biopsy confirmation of LSIL 
(Category C) cytology challenges used in PT testing. However, we are 
proposing at Sec.  493(c)(1)(iii), to retain biopsy confirmation of 
HSIL or cancer (Category D) cytology challenges.
    We are soliciting comment on the following:
     Should the requirement for biopsy confirmation of LSIL 
(Category C) cytology challenges for PT be retained?
     How many pathologists' diagnoses should be required for 
biopsy confirmation of these PT samples?

H. Validation of Cytology Challenges

    As previously stated, the requirements currently at Sec.  
493.945(b)(1), include the referencing of challenges by three 
physicians certified in anatomic pathology and biopsy confirmation. The 
CETC stated that this initial validation process is inadequate and 
without additional validation processes, could lead to indiscriminate 
failure of qualified, competent personnel. The CETC recommended that a 
requirement for field validation of the challenges before inclusion in 
PT events be added, stating that slides used for PT must demonstrate 
they can be interpreted in a consistent manner by a significant number 
of practicing cytologists. The organization further stated that field 
validation must consist of statistical assessment of the performance of 
each challenge under actual testing conditions. An example would be 
validation of at least 20 responses for each challenge with a correct 
response from participants at least 90 percent of the time.
    In addition, the CETC indicated that the validation must be ongoing 
with continuous monitoring because slides may become broken, faded, or 
the coverslip may become unattached during use and cease to meet 
validation criteria. The CETC recommended that individuals who fail a 
testing event based on a slide that falls below validation criteria for 
that testing cycle not be penalized and there should be no additional 
cost to the affected individual or his or her institution if retesting 
is necessary.
    The need for field validation of challenges is supported by a CDC 
study ``Comparison of Cytology PT--Glass Slides vs. Virtual Slides.'' 
See, 48 Acta Cytologica (2004) 788-794. The performance of the 
participants on glass-slide and computer-based PT were compared in this 
study. The glass-slide PT challenges were field validated by inclusion 
in several testing cycles, but the computer-based challenges were only 
referenced by three physicians certified in anatomic pathology. Four 
computer-based challenges failed to obtain a 90 percent consensus 
during field testing. When the four challenges were excluded from the 
scoring, the results were similar for both types of PT. The authors 
concluded that each challenge must be field validated by 
cytotechnologists and pathologists.
    The CLIAC acknowledged that all slides, particularly liquid-based

[[Page 3277]]

preparations, fade at a faster rate than conventional slides and may 
fail to meet field validation criteria over time. The CLIAC recommended 
adding a requirement for PT programs to field validate all challenges 
with continuous monitoring and removal of any challenge that fails to 
meet field validation criteria. The CLIAC also recommended that the 
validation process be disclosed to participants by the PT program. At a 
subsequent meeting, the PT programs suggested not including specific 
criteria for field validation in regulatory language, stating the 
criteria for validation may change as more knowledge is acquired about 
the process of validation and as technology changes.
    To ensure consistent testing and minimize the concerns about 
inappropriate cytology challenges, validation criteria would be 
assessed by CMS during the PT program approval and reapproval 
processes. Although we are not proposing in this rule to include 
specific criteria for validation, we are proposing at Sec.  
493.945(c)(1)(ii), that programs are required to field validate and 
disclose the validation process to their participants.
    We are soliciting comments on the following:
     Should the regulations include a requirement for field 
validation of each cytology challenge before inclusion in a test set?
     Should criteria for this initial field validation be 
stated in the regulations? If so, how should the criteria be defined?
     Should continuous monitoring of each cytology challenge be 
required?
     Should continuous monitoring criteria be specified in the 
regulations? If so what criteria should be required?
     Will the requirement for continuous field validation add 
any additional costs?

I. Scoring Scheme

    The regulations currently at Sec.  493.945(b)(3)(ii)(c) through 
(g), specify separate scoring schemes for cytotechnologists and 
technical supervisors (pathologists) for 10 slide and 20 slide tests. 
Cytotechnologists are not penalized for their inability to 
differentiate between LSIL (Category C) and HSIL or cancer (Category 
D), but technical supervisors (pathologists) lose points for 
incorrectly differentiating between the LSIL (Category C) and HSIL or 
cancer (Category D) categories.
    The 1992 scoring scheme awards partial credit to cytotechnologists 
for reporting unsatisfactory or negative challenges as LSIL (Category 
C) or HSIL or cancer (Category D). A passing score is at least 90 
percent as specified currently at Sec.  493.855(b)(2) and (b)(3). The 
CETC attributed the difference in pass rates of the cytotechnologists 
and pathologists to the 1992 scoring scheme which awards partial credit 
to cytotechnologists, but penalizes pathologists. The CETC recommended 
separate schemes be retained and include only a small penalty for a 
pathologist not distinguishing between LSIL (Category C) and HSIL or 
cancer (Category D); no penalty for responding that a normal or benign 
challenge is unsatisfactory; a penalty for reporting an unsatisfactory 
as normal or benign change; and a zero score for reporting an HSIL or 
cancer (Category D) as normal or benign change (false negative) and a 
normal or benign change as HSIL or cancer (Category D)(false positive). 
The ASCT suggested a unified scoring scheme, stating that while 
pathologists are responsible and accountable for reporting results, 
cytotechnologists are accountable for the initial location, 
interpretation and marking of representative cells. The ASCT also 
suggested that the highly punitive point deductions for a single 
discrepancy (calling an HSIL or cancer (Category D) a normal or benign 
change (Category B)) be eliminated.
    The CLIAC recommended the removal of the automatic failure for 
reporting one HSIL or cancer (Category D) as a Normal or Benign Change 
(Category B). The CLIAC discussed the need to score the test so that 
more points are lost for misinterpretation of HSIL or cancer (Category 
D) as a Normal or Benign Change (Category B), but not so many points 
that missing a single challenge results in a failing score (less than 
90 percent). It was noted that for a 20 slide test, a (-5), penalty for 
misinterpreting one HSIL or cancer (Category D) as a Normal or Benign 
Change (Category B) would result in a total loss of ten points which is 
a significant penalty commensurate with the seriousness of the error 
but does not result in an automatic failure. CLIAC also noted that if 
the point loss for a single challenge resulted in failure, the programs 
may be discouraged from including more than one of these types of 
challenges.
    CLIAC recommended balancing the removal of the automatic failure 
with removing the partial credit obtained by cytotechnologists for 
reporting an Unsatisfactory or Normal or Benign Change as LSIL 
(Category C) or HSIL or cancer (Category D). Partial credit is awarded 
under the 1992 scoring scheme to cytotechnologists because this 
reporting would result in the slide being referred to the pathologist 
for further review. However, if the overcall diagnosis is signed out by 
the pathologist, this results in over treatment of the patient which 
may have serious consequences (costs, stress on the patient, and can 
lead to unnecessary procedures that could result in patient 
infertility). It was also noted that a flattening of the point values, 
less partial credit awards and fewer points deducted for calling an 
HSIL or cancer (Category D) a negative would decrease the ``gaming'' 
aspects, especially if the number of cytology challenges are also 
increased to 20 as discussed previously under ``Number of Cytology 
Challenges.''
    CLIAC referenced another area where partial credit was not 
warranted was reporting an LSIL (Category C) challenge as 
Unsatisfactory (Category A). CLIAC noted this was one of the most 
reproducible diagnoses and that it would be reasonable to require both 
cytotechnologists and pathologists to make this distinction.
    In consideration of the many comments and recommendations, in this 
proposed rule, the scoring scheme awards fewer partial credits to 
discourage over reporting and reduce the gaming aspects. It also 
eliminates the automatic failure for misdiagnosis of a single HSIL or 
cancer (Category D), which would balance the loss of partial credit for 
over reporting a single cytology challenge.
    Although the ASCT suggested that a passing score should be changed 
from at least 90 percent to at least 80 percent, CMS experience with 
testing for the 2005 and 2006 testing cycles (see tables for data on 
the first and second failure rates for 2005 and 2006 testing cycles) 
demonstrates a low rate of failure on the initial test and an even 
lower failure rate on subsequent retests. Therefore, we propose at 
Sec.  493.853(b)(3) to retain the 90 percent or higher as the passing 
score.

[[Page 3278]]

[GRAPHIC] [TIFF OMITTED] TP16JA09.002


------------------------------------------------------------------------
             Failure rate initial tests                 2005     2006 *
------------------------------------------------------------------------
Total Number Tested.................................    12,831    12,217
Total Number of Failures............................     1,177       653
Cytotechnologists...................................       447       282
Pathologists Without Cytotechnologists**............       156        74
Pathologists With Cytotechnologists**...............       570       297
------------------------------------------------------------------------
* Preliminary 2006 Data (January 1, 2006 through January 14, 2007).
Note: 2005 Data included a category of individuals (cytotechnologists
  and pathologists) who were not employed permanently at one laboratory
  during the year. Four of these individuals failed the first test but
  were not included in the bar graph.
** From a personnel perspective, cytology laboratories may be structured
  differently from one another. Currently the majority of laboratories
  have a pathologist who is assisted by a cytotechnologist during their
  daily routine. In such situations the cytotechnologist is generally
  responsible for locating and identifying cells that are abnormal. The
  pathologist would then be responsible for issuance of the final
  diagnosis on the slide in question. These scenarios are what is meant
  by ``Pathologists with Cytotechnologists'' in the charts located in
  this section. ``Pathologists with Cytotechnologists'' are tested in a
  manner similar to their daily routine. Pathologists who are assisted
  by cytotechnologists are given a choice to be tested with a test set
  that has been previously examined by a cytotechnologist who located
  and identified the abnormal cells or the pathologist may choose to be
  tested with a test set that has not been previously examined. The
  remainder of the pathologists work in laboratories where they are
  required to locate and identify abnormal cells and issue a final
  diagnosis without the assistance of a cytotechnologist. These
  scenarios are what is meant by ``Pathologists without
  Cytotechnologists'' in the charts. Pathologists who work without a
  cytotechnologist must be tested in the same manner as they perform
  their daily routine. They are therefore to be tested on a test set
  that has not been previously examined by a cytotechnologist.


[[Page 3279]]

[GRAPHIC] [TIFF OMITTED] TP16JA09.003


------------------------------------------------------------------------
         Failure rate second test  (1st retest)            2005   2006 *
------------------------------------------------------------------------
Total Number Tested.....................................   1,128     509
Total Number of Failures................................     110      33
Cytotechnologists.......................................      17      13
Pathologists Without Cytotechnologists..................      45       7
Pathologists With Cytotechnologists.....................      45      13
------------------------------------------------------------------------
* Preliminary 2006 Data (January 1, 2006 through January 14, 2007).
Note: 2005 Data included a category of individuals (cytotechnologists
  and pathologists) who were not employed permanently at one laboratory
  during the year. Three of these individuals failed the second test but
  were not included in the bar graph.

    We propose to change the point values for a 20 cytology challenge 
test for a technical supervisor qualified under Sec.  493.1449(b) or 
(k) to the following:

----------------------------------------------------------------------------------------------------------------
                                                                  Technical supervisor examinee response
                    Correct response                     -------------------------------------------------------
                                                            A--UNSAT     B--NEGATIVE     C--LSIL       D--HSIL
----------------------------------------------------------------------------------------------------------------
A--UNSAT................................................           5             0             0             0
B--NEGATIVE.............................................           2.5           5             0             0
C--LSIL.................................................           0             0             5             2.5
D--HSIL.................................................           0            -5             2.5           5
----------------------------------------------------------------------------------------------------------------

    We propose to change the point values for a 20 cytology challenge 
test for a cytotechnologist qualified under Sec.  493.1469 or Sec.  
493.1483 to the following:

----------------------------------------------------------------------------------------------------------------
                                                                      Cytotechnologist examinee response
                      Correct response                      ----------------------------------------------------
                                                               A--UNSAT    B--NEGATIVE    C--LSIL      D--HSIL
----------------------------------------------------------------------------------------------------------------
A--UNSAT...................................................           5              0            0            0
B--NEGATIVE................................................           2.5            5            0            0
C--LSIL....................................................           0              0            5            5
D--HSIL....................................................           0             -5            5            5
----------------------------------------------------------------------------------------------------------------


[[Page 3280]]

    Comments are solicited on the following:
     Should the automatic failure for misdiagnosing an HSIL or 
cancer (Category D) as a Normal or Benign Change (Category B) be 
retained for pathologists and cytotechnologists?
     Should pathologists and cytotechnologists be evaluated 
using the same scoring scheme? If not, how should the scoring grid be 
composed?
     Should the cytotechnologist scoring scheme be more 
stringent than the current regulations?
     How would the same scoring scheme meet the statutory 
requirement for evaluating workplace performance of both 
cytotechnologists and pathologists with respect to their 
responsibilities in reviewing cytology preparations?
    CMS has requested additional information from cytology PT providers 
to analyze trends in PT failures over time. This information should 
include, at a minimum, the impact of automatic failures due to missed 
High-Grade Lesions (HSIL), and the impact of false positives and false 
negatives on scores over time. Examples of information to be collected 
include:
     The number of automatic failures;
     The number of automatic failures with additional false 
positives;
     The number of automatic failures with additional false 
negatives;
     The number of automatic failures with both additional 
false positives and false negatives;
     The number and types of false positives that led to PT 
failure; and
     The number and types of false negatives that led to PT 
failure over time.

J. Retesting and Remediation

    The requirements currently at Sec.  493.855(b) allow a series of 
retests and remediation when an individual fails a testing event (that 
is, scores less than 90 percent). The CLIAC recommended changing the 
regulatory language to eliminate the word ``fail'' when an individual 
scores less than 90 percent to convey that an individual has not failed 
PT until all retesting is complete.
    Under the current regulations, it is at the discretion of the PT 
program to select the type of information concerning incorrect 
responses to be provided to assist laboratories and individuals in 
determining the area(s) for remediation. For education and remediation, 
the CLIAC recommended that PT programs share additional, more specific 
information to examinees on each challenge that was missed.
    The requirements currently at Sec.  493.855(b)(1), requires 
retesting of any individual who does not obtain a score of at least 90 
percent on a testing event. The ASCT commented that the regulation is 
confusing as to the total number of testing events permitted for an 
individual and recommended that only two retesting events (three total 
attempts) be allowed. The ASCT also suggested that all retesting events 
be performed at the individual's laboratory, rather than at the PT 
program's facility.
    We are proposing to replace the term ``failure'' currently at Sec.  
493.855(c) with ``scores less than 90 percent'' in proposed Sec.  
493.853(c). The requirements currently at Sec.  493.855(b)(2) and 
(b)(3), that laboratories provide remedial training and education in 
the area of failure, are retained in this proposed rule at Sec.  
493.853(c)(2)(i) and Sec.  493.853(c)(3)(i), respectively. We are 
proposing to maintain the requirements at Sec.  493.945 applicable to 
each approved PT program and to the approval and reapproval processes, 
and CMS would continue to review the information provided by PT 
programs to accompany the test score. The requirements currently at 
Sec.  493.855(b)(2) and (b)(3), that laboratories provide remedial 
training and education in the area of failure, are retained in this 
proposed rule at Sec.  493.853(c)(2)(i) and Sec.  493.853(c)(3)(i), 
respectively. CMS is retaining the current requirement for an initial 
retest to take place not more than 45 days after receipt of 
notification of failure. In the event remediation is required as under 
proposed Sec. Sec.  493.853(c)(2) and 493.853(c)(3), CMS is proposing 
to impose a 45 day period for retests, which will commence at the 
completion of remedial training at Sec.  493.853(c)(2)(iii) and Sec.  
493.(c)(3)(iii). Currently, the PT programs determine the site of 
retesting events with CMS approval. We are proposing to retain this 
requirement in this rule, but solicit comments on this subject as 
follows:
     Should the PT programs provide more specific information 
concerning incorrect responses to the laboratory and individual to 
improve the testing process? Please clarify what information should be 
provided.
     Should all testing be conducted in the laboratory or 
should some testing be conducted at the location of the PT program?
     How many times should an individual be permitted to take a 
retest? Please provide rationale to support your recommendation.

K. Appeals Process

    At this time, the PT program requirements for approval do not 
include an appeals process. However, CMS asks PT programs to describe 
their appeals process when applying for CMS approval and reapproval. It 
was noted at the June 2006 CLIAC meeting that some individuals were not 
aware they could appeal their score during the 2005 testing cycle 
because a written description of the appeals process was not provided 
by the PT program to participants unless requested. The CLIAC 
recommended that the PT programs describe their appeals process to all 
participants before enrollment in the program.
    We are proposing at Sec.  493.945(b)(4), that the PT program 
provide a written description of the appeals process and make it 
available to all enrolled individuals.
    We are soliciting comments on the following:
     What criteria should be included in an appeals process?
     Should PT programs be required to provide participants 
with a description of their appeals process?
     When should a description of the appeals process be shared 
with the participants?

L. Testing Site for the First Event

    The provisions currently at Sec.  493.855(a) require announced or 
unannounced on-site testing for the first testing event. We are 
retaining this statutory requirement for on-site testing. However, a 
few individuals have requested more choices for testing locations 
including but not limited to professional meetings, seminars, and trade 
shows. We are soliciting the public's comments on this proposal.

M. Proctors

    In the February 28, 1992 final rule with comment, we were silent on 
the use of a proctor to administer the testing event on-site. During 
the ongoing discussion with CAP regarding approval of their cytology PT 
program, CAP asked CMS whether in-house proctors could be used to 
administer the test. CAP stated that it would be less costly for 
programs and ultimately for laboratories if PT programs were able to 
use in-house laboratory personnel as test proctors. MIME also requested 
using laboratory proctors in their initial application.
    During the review process, CMS evaluated the procedures the 
programs would use to ensure the integrity of the testing event. Both 
programs were approved allowing the use of in-house laboratory 
personnel as test proctors. At the August 2006 meeting, the PT programs 
were asked if the proctor responsibilities should be the laboratory's 
responsibility. Recommendations were made to hold

[[Page 3281]]

the laboratory responsible for proper administration of the testing 
event.
    The CLIAC recommended that the PT programs determine the proctor 
requirements. However, to maintain consistency among programs, all PT 
programs must meet the same requirements. We are proposing at Sec.  
493.945(b)(5) and (b)(6), to add the following requirements: (1) PT 
programs must provide training for the laboratory proctor, which 
includes written instructions for the laboratory to determine the 
number of proctors needed to administer the PT event and a contingency 
for a backup proctor; (2) written instruction for the laboratory 
director and proctor to ensure program procedures are fulfilled; (3) a 
proctor examination that evaluates the proctor's understanding of 
proper testing protocol; and (4) the laboratory director must sign a 
written agreement stating the laboratory is responsible for and accepts 
responsibility for administering the PT as defined by the program and 
CMS. In the event of an improperly administered test, each individual 
tested in the laboratory would be assigned a score of ``zero''. We are 
also proposing a prohibition on the use of resources capable of 
assisting individuals with the interpretation of testing materials 
during the testing event, and on duplication of testing material by any 
means including photography.
    We invite comments on the following:
     What specific criteria should there be for selection of 
the proctor?
     How often should proctor training and testing be required?
     What penalties should be applied to laboratories and 
individuals when testing is not conducted according to requirements?

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

V. Collection of Information Requirements

    Under the Paperwork Reduction Act (PRA) of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the PRA of 1995 requires that 
we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    Therefore, we are soliciting public comments on each of these 
issues for the information collection requirements discussed below.

    Note: All of the data that follows are based on actual 2005 
cytology proficiency testing data. The 2006 data are significantly 
lower. The Paperwork Reduction Act (PRA) at 1320.3(h)(7) (5 CFR Part 
1320) states that examinations designed to test the aptitude, 
abilities, or knowledge of persons tested and the collection of 
information for identification or classification in connection with 
such examinations are not considered ``information'' under the PRA 
and is exempt from burden estimates unless the Office of Management 
and Budget determines otherwise. Therefore, this section below 
applies to laboratories and laboratory employees, but does not apply 
to the proficiency testing programs described in this rule.

    Condition: Cytology: gynecologic specimen examinations Sec.  
493.853.
    Section 493.853(a)(2) states that the laboratory must provide the 
Proficiency Testing (PT) program with information necessary to identify 
all laboratory employees at its facility who are to be tested.
    The burden associated with this requirement is the time and effort 
put forth by the laboratory to provide the necessary information. The 
estimated total number of laboratory employees taking the PT once every 
2 years is approximately 12,831. It will take an estimated 5 minutes 
per person to provide the information necessary to enroll for testing. 
The approximate biennial total per laboratory employee is 5 minutes. 
Therefore the total annual burden is 533.4. (12,831 laboratory 
employees x 0.08 hours = 1026.48 biennial hours or 513.24 hours 
annually)
    Section 493.853(b)(2) requires a laboratory to notify each 
laboratory employee of the date, time and location of testing.
    The burden associated with this requirement is the time and effort 
put forth by the laboratory to notify its employees. We estimate the 
total number of laboratories is 2,142 in which a total of approximately 
12,831 laboratory employees are employed, who need to be notified once 
every 2 years. It will take less than one minute for the laboratory to 
notify its employees of the date, time and location of testing. The 
total burden is one minute per laboratory and the national biennial 
total burden is 2,142 minutes or 35.7 hours. The annual burden is 17.8 
hours.
    Section 493.853(b)(3)(ii) states that for an individual with an 
excused absence, the laboratory must contact the PT program to 
determine the date, time, and location of the make-up examination.
    The burden associated with this requirement is the time and effort 
put forth by the laboratory to obtain the information. There will be 
approximately 260 excused absences in a 2 year testing period. It will 
take approximately 10 minutes to contact the PT program to gather this 
information. The estimated biennially total is 10 minutes per 
laboratory employee and the national total burden is 44.2 hours 
biennially. (260 excused absences x .17 hours = 44.2 hours OR 22.1 
hours annually)
    Section 493.853(c)(2)(i) states that when a laboratory employee 
fails the cytology PT test the second time, he or she must obtain 
documented remedial training and education in the area of failure.
    The burden associated with this requirement is the time and effort 
put forth by the employee to complete training and obtain documentation 
of that training. There will be approximately 110 laboratory employees 
who fail the second test (performed on-site at the laboratory). It will 
take approximately 4 hours per laboratory employee to complete the 
remedial training and obtain the necessary documentation. The national 
total is 440 hours biennially. (110 laboratory employees x 4 hours = 
440 hours biennially OR 220 hours annually)
    Section 493.853(c)(2)(ii) states that if a laboratory chooses to 
direct a laboratory employee who failed the first and second tests to 
continue examining patient Pap smears, all patient Pap smears must be 
re-examined by a laboratory employee who has passed the PT test and the 
re-examination must be documented.
    The burden associated with this requirement is the time and effort 
put for by the laboratory to document that the patient Pap smears were 
re-examined. There will be approximately 110 laboratory employees who,

[[Page 3282]]

biennially, fail the second tests. It will take an estimated 10 seconds 
per slide to document that patient Pap smears were re-examined. 
Considering an average of 75 Pap smears that would be examined per day 
by a laboratory employee who would re-examine patient smears, the 
estimated total burden biennially for each laboratory employee who is 
re-screening smears is, 12.5 minutes per day or .21 hours. There would 
be approximately 20 working days until each laboratory employee may be 
retested. Each laboratory employee's burden is 4.17 hours; therefore, 
the total national burden is 34,650 hours, biennially. (Rescreening 
Time: 75 slides per day x 20 days = 1,500 slides to be rescreened per 
failed laboratory employee. 1,500 slides per failed laboratory employee 
x 110 failed employees = 165,000 slides to be rescreened. 165,000 
slides to be rescreened x .21 hours per slides = 34,650 hours OR 17,325 
hours annually. Documentation Time: 165,000 slides to be rescreened x 
.003 hours = 495 hours biennially OR 247.5 hours annually.)
    Section 493.853(c)(3) states that when a laboratory employee has 
failed the first, second, and third cytology PT test, he or she must 
obtain 35 hours of documented, continuing education and discontinue 
examining patient Pap smears until he or she passes a PT test.
    The burden associated with this requirement is the time and effort 
put forth by the employee to obtain and document the continuing 
education. There will be approximately 10 laboratory employees, 
biennially, who fail three tests. It will take an estimated 35 hours to 
obtain the required continuing education per laboratory employee. The 
total national burden, biennially, will be approximately 350 hours. (10 
laboratory employees x 35 hours = 350 hours biennially OR 175 hours 
annually)
    Cytology: gynecologic examinations Sec.  493.945.
    While the requirements below are subject to the PRA, we believe the 
burden associated with these requirements is exempt from the 
requirements of the PRA as defined in 5 CFR 1320.3(h)(7).
    Cytology: gynecologic examinations Sec.  493.945.
    Section 493.945(a) requires PT programs to notify the laboratory at 
least 30 days before the testing event of the location, date, and time 
of testing. For those individuals who score less than 90 percent on the 
initial testing event, a second test must be scheduled by the 
laboratory and the individual must take the test within 45 days after 
the laboratory is notified to ensure the laboratory's compliance with 
Sec.  493.853(c).
    Section 493.945(b)(1)(i) states that if slides are still subject to 
retention by the laboratory, they may be loaned to a proficiency 
testing program if the program provides the laboratory with 
documentation of the loan of the slides and ensures that slides loaned 
to it are retrievable upon request.
    Sections 493.945(b)(4), (5), and (6) require the program to:
     Provide a written description of the appeals process that 
is available to all individuals enrolled in the program.
     Provide training for laboratory designated proctors that 
includes--
    (1) Written instructions for the laboratory to determine the number 
of proctors needed to administer the proficiency testing event, 
including contingency for a backup proctor if needed;
    (2) Written instructions for the laboratory director and proctor to 
ensure program procedures are fulfilled; and
    (3) A proctor examination that evaluates the proctor's 
understanding of proper testing protocol.
    Provide a written agreement, to be signed by the laboratory 
director and returned to the program before testing, stating the 
laboratory is responsible for and accepts responsibility for 
administering the proficiency testing as defined by the program and 
CMS.
    Section 493.945(c)(1)(ii) requires the program to disclose their 
method of continuous field validation to participants before enrollment 
in the program.
    We have submitted a copy of this proposed rule to OMB for its 
review of the information collection requirements described above. 
These requirements are not effective until they have been approved by 
OMB.
    If you comment on these information collection and recordkeeping 
requirements, please do either of the following:
    1. Submit your comments electronically as specified in the 
ADDRESSES section of this proposed rule; or
    2. Mail copies to the address specified in the ADDRESSES section of 
this proposed rule and to the Office of Information and Regulatory 
Affairs, Office of Management and Budget, Room 10235, New Executive 
Office Building, Washington, DC 20503, Attn: CMS Desk Officer, OIRA_submission@omb.eop.gov or fax (202) 395-6974.

VI. Regulatory Impact Statement

A. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on 
Federalism, and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Order 12866 (as amended by Executive Order 13258, which 
merely reassigned responsibility of duties) directs agencies to assess 
all costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
We do not believe this proposed rule would constitute an economically 
significant rule because it has no budget implications that would 
impact Medicare and Medicaid benefit payments by over $100 million in 
any one year. However, if finalized, the proposed rule would revise the 
requirements for cytology proficiency testing (PT) and would affect 
laboratories and individuals now subject to participation in PT, and 
could have some budget implications. In addition, this proposed rule, 
if finalized, would revise the requirements for cytology PT programs, 
which would cause the three existing PT programs to incur some costs as 
they modify their CMS-approved programs to meet the requirements 
specified in this rule. It may also have an effect on some States 
regarding State PT requirements. Therefore, we have prepared a RIA 
although the specified threshold to require a full analysis has not 
been met.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses, if a rule has a significant impact on a 
substantial number of small entities. For purposes of the RFA, almost 
all cytology laboratories are considered to be small entities. The 
cytology PT programs are also considered small entities due to their 
nonprofit status. Individuals and States are not included in the 
definition of a small entity. Based on our initial analysis, we expect 
that this proposed rule would not have a significant impact on a 
substantial number of small

[[Page 3283]]

businesses or other small entities because only two of the proposed 
changes to the current PT requirements are anticipated to have non-
negligible impacts, and these two changes are largely offsetting (that 
is, the increase in number of cytology challenges per test from 10 to 
20, and decreased frequency of testing from annually to every other 
year). For the two year test cycle, there would be no increase in the 
amount of time an individual would spend taking the test. And although 
the number of challenges per test would increase, because the frequency 
of testing would decrease, programs would not need to increase the 
inventory of challenges to provide testing. Therefore, the Secretary 
has determined that this proposed rule would not have a significant 
economic impact on a substantial number of small entities.
    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. This 
analysis must conform to the provisions of section 603 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 100 beds. This proposed rule would 
not affect small rural hospitals because only two of the proposed 
changes to the current PT requirements are anticipated to have non-
negligible impacts, and those two changes are largely offsetting (that 
is, the increase in number of cytology challenges per test from 10 to 
20, and decreased frequency of testing from annually to every other 
year). Therefore, for purposes of our obligations under section 1102(b) 
of the SSA, we are not providing an analysis.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. That threshold 
level is currently approximately $130 million. Based on our assessment, 
this rule would have no consequential effect on State, local, or tribal 
governments, or on the private sector. We anticipate that States will 
not incur substantial costs if this proposed rule is finalized because 
it does not contain changes that would result in significant cost 
differences from the regulations that are currently in place. We have 
determined that this proposed rule generally does not significantly 
affect States' rights, roles, and responsibilities. This proposed rule 
would impact one State cytology PT program (Maryland), which currently 
meets the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 
requirements for CMS approval, and would require the State to update 
their program requirements to meet the new final requirements.
    The objective of this regulatory impact analysis is to summarize 
the cost and benefits of implementing the regulations we are proposing. 
The conclusions and assumptions contained in this RIA are based on 
cytology PT data from 2005, the first year national testing took place.
    Public health benefits are not anticipated from the proposed 
changes to the cytology PT requirements compared to those in the 
existing regulation in terms of reducing the number of incorrect 
diagnoses or other public health measures (for example, reduction in 
false negative or false positive cervical cancer diagnoses, reduction 
in cervical cancer morbidity or mortality) based on analysis of 
relevant available data. As no data are available to suggest otherwise, 
we believe that the proposed changes may produce virtually the same 
results as the existing regulation in terms of PT outcomes (for 
example, examinee proficiency, number of examinees passing each test). 
We believe that the proposed regulations will result in a reduced 
burden on the population being tested and their employers. Some of this 
reduced burden is quantifiable in monetary terms as cost savings 
associated with less frequent testing; however, other effects can not 
be quantified.
    No distributional effects from the proposed changes are anticipated 
as they do not result in significant changes in treatments or outcomes 
for different groups. Further, the proposed changes are unlikely to 
increase market prices for Pap smears or other health care costs as 
they are not anticipated to result in any significant change in PT 
outcomes, or to increase the costs associated with gynecologic cytology 
PT.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. This proposed rule will not have a substantial direct 
effect on State or local governments, preempt States, or otherwise have 
a Federalism implication.

B. Anticipated Effects

    This proposed rule includes changes that, if finalized, would 
impact 2,142 cytology laboratories and 12,831 individuals (reference: 
http://www.cms.hhs.gov/CLIA/downloads/2005FinalTestingResults080906MDMIME.pdf) who screen or interpret the 65 
million gynecologic cytology preparations in the U.S. each year 
(references: Solomon D., Breen N., and McNeal T. Cervical cancer 
screening rates in the United States and the potential impact of 
implementation of screening guidelines: 57(2)CA A Cancer Journal for 
Clinicians, 105-111(2007) and Eltoum I. A., and Roberson J.: Impact of 
HPV testing, HPV vaccine development, and changing screening frequency 
on national Pap test volume, 111(1) Cancer Cytopathology 34-40(2007)). 
These laboratories and individuals are required to participate in PT 
under the regulations implemented by the February 28, 1992 final rule 
with comment implementing the CLIA statute. This proposed rule also 
includes changes that would impact the three existing CMS-approved 
cytology PT programs.
    Although we have insufficient data to calculate the actual costs 
and benefits that would result from these proposed changes, we are 
providing an analysis of the potential impact based on available 
information and certain assumptions. We expect these proposed 
requirements to result in a negligible increase in burden or cost to 
the PT programs and a decreased burden for laboratories and 
individuals, with little or no change in the cost for laboratory or 
individual participation in cytology PT. We do not anticipate there 
would be any effect on the Medicare and Medicaid programs.
    This proposed rule includes requirements for laboratories, 
individuals who conduct cytology testing, and cytology PT programs that 
would revise those specified in the February 28, 1992 final rule with 
comment. Implementation of these proposed requirements in a final rule 
would result in changes that are anticipated to have quantifiable and 
non-quantifiable impacts.
    The following proposed regulatory changes, if finalized, will 
result in quantifiable impact:
     Decrease the testing frequency from once per calendar year 
to once every two calendar years.
     Increase the number of cytology challenges per testing 
event for the first two testing events from 10 to 20 and require no 
more than 4 hours rather than the current 2 hours for completion of the 
test.

[[Page 3284]]

    The following changes are anticipated to have minor impact on 
regulated parties, but data are insufficient to quantitatively evaluate 
their effects:
     Expand test medium options to allow other potential media 
such as computer-based virtual slides or alternative testing formats, 
in addition to glass slide cytology challenges.
     Revise the scoring scheme for technical supervisors 
(pathologists) and cytotechnologists to eliminate the partial credit 
for reporting response Category C (LSIL) as response Category A 
(Unsatisfactory) and reduce the penalty score for reporting response 
Category D (HSIL or cancer) as response Category B (Normal or Benign 
Changes). In addition, for cytotechnologists, remove the partial credit 
for over reporting response Category A (Unsatisfactory) and response 
Category B (Normal or Benign Changes) cytology challenges as either 
response Category C (LSIL) or response Category D (HSIL or cancer).
     Eliminate the requirement for tissue biopsy confirmation 
of response Category C (LSIL) cytology challenges.
     Make the laboratory director responsible for ensuring 
proper test administration (meeting CMS requirements) when PT is held 
on-site in the laboratory and reporting identifying information for all 
individuals to CMS and PT programs.
     Allow appropriately trained proctors to administer the 
testing event on-site in the laboratory.
     Revise the description of the response Category A 
(Unsatisfactory) to reflect the current Bethesda 2001 Terminology 
criteria for ``unsatisfactory for diagnosis'' as approved by CMS.
     Increase the required number of response Category D (HSIL 
or cancer) cytology challenges to at least two in a 20 cytology 
challenge test, which is equivalent to the current requirements for one 
per 10 challenge test.
     Require continuous field validation of cytology challenges 
throughout their use in testing.
     Require the PT program to inform participants of the 
appeals process in writing.
    The potential impact of each of these proposed changes is discussed 
below.
1. Quantifiable Impact
    Decrease the testing frequency from once per calendar year to once 
every two calendar years and increase the number of cytology challenges 
per testing event for the first two tests from 10 to 20, requiring no 
more than 4 hours rather than the current 2 hours for completion of the 
test.

a. Rationale

    The 10 slide test required once per calendar year in the current 
rule was implemented to limit the number of slides that would have to 
be accumulated and referenced to provide national testing to all 
individuals who examine gynecologic cytology preparations. The increase 
in the number of cytology challenges from 10 to 20 is proposed in 
conjunction with the increase in time between testing events from 1 to 
2 year cycles. These changes are linked and are considered here 
together.
    The rationale for increasing the number of test challenges from 10 
to 20 is to improve the test sensitivity. Generally, increasing the 
challenges from 10 to 20 for the initial test and first retest in this 
proposed rule was based on the desire to increase statistical validity, 
while also attempting to minimize the overall costs expended to provide 
and take a test with a larger number of challenges.
    With regards to the temporal spacing of tests, the skills required 
in locating and identifying cytologic abnormalities are not quickly 
lost. These skills are based on knowledge and memory, or ``semantic'' 
knowledge accumulated by training and experience and this knowledge is 
durable (Nagy G.K. and Newton L.E., Cytopathology proficiency testing: 
Where do we go from here? 34(4)Diagnostic Cytopathology 257-264 
(2006)). Therefore, it is not expected that cytotechnologists and 
pathologists, who routinely examine gynecologic cytology specimens, 
would lose these skills and knowledge over a period of 1 year or 2 
years.

b. Potential Impact

    Increasing the number of cytology challenges to 20 for each test is 
proposed in conjunction with decreasing the testing frequency from 
annual testing to ``at least once every 2 calendar years.'' These 
changes would have the following effects on laboratories:
     Decrease the burden by decreasing the frequency for which 
laboratories would have to prepare for testing (for example, the time 
needed to schedule testing, provide for proctor training, proctor 
preparation for the testing event, and arranging for make-up testing 
for individuals who miss the testing event or retesting for individuals 
scoring less than 90 percent).
     Increase the length of time for taking the first two tests 
from 2 hours to 4 hours corresponding to the increase in number of 
cytology challenges from 10 to 20.

c. Estimated Costs

    The baseline for measuring costs and benefits of the proposed 
change is found in the existing regulation that is equivalent to no 
change. The primary cost impacts of the proposed change compared to the 
baseline are attributable to time-related changes: (1) A reduction in 
the frequency of testing from annually to every other year; and (2) an 
increase in the time needed to take each of the first two tests by 
increasing the number of cytology challenges from 10 to 20. To reflect 
the impact of these time-related changes and permit meaningful 
comparison, annual testing costs are estimated for a common base 
population of examinees. The costs of the proposed changes (testing 
every other year with 20 cytology challenge tests for all tests) are 
estimated using one-half of the base population, and the costs of the 
existing regulation (annual testing with 10 challenge tests for the 
first and second tests; 20 cytology challenge tests for the third and 
fourth tests) are estimated using the entire base population. Annual 
testing costs are expressed in constant 2005 dollars.
    A lack of detailed information about testing costs and related 
resource use precludes the use of scientifically defensible probability 
distributions for cost estimates. The assumptions used and described 
constitute plausible alternatives, which provide a reasonable basis for 
calculation of costs. These assumptions are stated explicitly, and most 
include a range of estimates represented by a high and low value, such 
that all values with lower cost implications are reflected in the total 
low estimates and those with higher cost implications are reflected in 
the total high estimates. The assumptions stated below are used to 
estimate the annual testing costs under the existing regulation and for 
the proposed changes in testing frequency and number of cytology 
challenges.
    The primary costs associated with cytology PT under the existing 
regulation and the proposed changes are the value of lost examinee and 
proctor work time associated with testing requirements. The assumptions 
used to estimate the time requirements are detailed below. Other costs 
associated with operating cytology PT programs are not quantified due 
to the limited information concerning these costs, and that the most 
substantial ones can be characterized as sunk (fixed) costs required 
for initial start-up of a program. Initial and ongoing slide 
acquisition costs are assumed to be negligible as they are currently 
donated. Ongoing

[[Page 3285]]

costs for sustaining program operations are primarily fixed costs 
including overhead, administration, challenge referencing, challenge 
validation, maintenance and storage costs. The requirement for 
continuous field validation as proposed in this rule would be new; 
however, the existing CMS-approved PT programs have already implemented 
validation processes. We assume that these costs would continue at more 
or less the same level as long as there is a regulation requiring 
cytology PT using the current technology, so the anticipated cost 
impact for the proposed changes is assumed to be negligible over time. 
If a program incorporates new technology, we would anticipate an 
initial increase for start-up costs which may be offset by decreased 
operating costs over time for the program, but actual costs for such a 
program are unknown at this time. We are soliciting input from the 
public on this subject.

d. Examinee Population

    The base population used for this impact analysis consists of a 
total of 12,831 individuals taking the first test with the following 
breakdown; 6,530 (50.9 percent) cytotechnologists, 5,833 (45.5 percent) 
pathologists with cytotechnologists, and 468 (3.6 percent) pathologists 
without cytotechnologists based on CMS' Final 2005 National Cytology 
Proficiency Testing Results. (Table 1, Source: http://www.-cms.-hhs.-
gov/-CLIA/-downloads/-2005-Final-TestingResults-080906MDMIME.pdf, 
accessed 4/13/2007). The same base population is assumed to take the 
first test annually under the existing regulation. For the proposed 
change to testing every other year, it is assumed that one-half of this 
base population of examinees will test each year. This assumption is 
consistent with information received from the current PT program 
regarding how they would implement the proposed change. For annual 
testing under the existing regulation, the number of examinees for the 
second, third, and fourth tests corresponds to the 2005 base population 
used for the first test, and is based on this population's test results 
from the same source as follows in the table below. Similarly, for the 
proposed change to testing every other year, it is assumed that one-
half of these examinees will test each year.

                              Table 1--Base Population Number of Examinees by Test
----------------------------------------------------------------------------------------------------------------
                                                                 First        Second       Third        Fourth
----------------------------------------------------------------------------------------------------------------
Cytotechnologists...........................................        6,530          435           13            0
Pathologists with Cytotechnologists.........................        5,833          561           31            3
Pathologists only...........................................          468          132           16            1
                                                             ---------------------------------------------------
    Total...................................................       12,831        1,128           60            4
----------------------------------------------------------------------------------------------------------------
Source: CMS' Final 2005 National Cytology Proficiency Testing Results.

e. Hourly Salary and Total Compensation

    Cytotechnologist hourly compensation is assumed to range from 
$36.64 to $42.76 in 2005 dollars. This range of estimates is based on 
the 2005 hourly median wage rates of $26.17 reported for 
cytotechnologist staff for the low estimate and of $30.54 for 
cytotechnologist supervisor for the high estimate by the ASCP 2005 Wage 
and Vacancy Survey, which were then multiplied by 1.4 to estimate total 
hourly compensation including benefits. These wage rates are similar to 
those reported by the U.S. Department of Labor, Bureau of Labor 
Statistics, Occupational Employment Statistics, May 2005 national wage 
estimates for Medical and Clinical Laboratory Technologists (29-2011) 
at the 75th and 90th percentiles, $26.94 and $31.98, respectively. 
(Steward, CA and NM Thompson, ASCP 2005 Wage and Vacancy Survey. Lab 
Medicine 37(8): 465-469, 2006)
    Pathologist hourly compensation is assumed to range from $58.98 to 
$117.77 in 2005 dollars. This range of estimates is based on the 2005 
mean hourly wage rates of $42.13 reported for Health Diagnosing and 
Treating Practitioners, All Other (29-1199) for the low estimate, and 
of $84.12 reported for Physicians and Surgeons, All Other (29-1069), 
Medical and diagnostic laboratories for the high estimate by the U.S. 
Department of Labor, Bureau of Labor Statistics, Occupational 
Employment Statistics, May 2005, which were then multiplied by 1.4 to 
estimate total hourly compensation including benefits.

                         Table 2--Hourly Salary and Total Compensation Cost Assumptions
                                                 [2005 dollars]
----------------------------------------------------------------------------------------------------------------
                                                                       Salary              Total compensation
                                                             ---------------------------------------------------
                                                                  Low          High         Low          High
----------------------------------------------------------------------------------------------------------------
Cytotechnologist............................................       $26.17       $30.54       $36.64       $42.76
Pathologist.................................................        42.13        84.12        58.98       117.77
----------------------------------------------------------------------------------------------------------------

f. Examinee Time and Travel

    1. First and second tests.
    Under both the existing regulation and the proposed changes, it is 
assumed for simplicity sake that 100 percent of testing is on-site, 
requiring only examinee time for taking the test.
    10 challenge test: Examinee time for taking the test under the 
current regulation requiring annual testing with a 10 challenge test 
for the first and second tests for cytotechnologists and pathologists 
without cytotechnologists is assumed to range between a low of 1 hour 
and a high of 2 hours, the maximum allowed time. For pathologists with 
cytotechnologists, the time for taking the 10 challenge test for the 
first and second tests ranges from 30 minutes to 2 hours, the maximum 
allowed time. (Gagnon M.B., Inhorn S., and Hancock J. et al. Comparison 
of Cytology Proficiency Testing--Glass Slides vs. Virtual Slides 
48(6)Acta Cytologica: 788-794(2004))

[[Page 3286]]

    20 challenge tests: For cytotechnologists and pathologists without 
cytotechnologists, examinee time is assumed to range between a low of 2 
hours and a high of 4 hours, the maximum allowed time. For pathologists 
with cytotechnologists it is assumed to range between a low of 1 hour 
and a high of 4 hours, the maximum allowed time.
    2. Third and fourth test.
    Travel and test time: Under both the existing regulation and the 
proposed changes, it is assumed for simplicity sake that 100 percent of 
testing is off-site, requiring examinees to travel. (The third test may 
be on-site; however, a cytology PT program proctor is required, so in 
either case, at least one person must travel and incur travel-related 
costs.) Examinee travel time under the existing regulation and the 
proposed changes is assumed to require 2 lost work days of 8 hours 
each. This would be the total combined amount of examinee time lost due 
to taking the test and traveling. (Under both the existing regulation 
and the proposed changes, third and fourth tests are 20 cytology 
challenge tests.)
    Individuals taking the third and fourth tests are assumed to incur 
travel expenses for off-site testing. Travel-related expenses per 
examinee for each test are assumed as follows: $350 for transportation-
related costs (airfare and ground transportation) plus 2 days at the 
maximum federal per diem expense for unspecified locations (includes 
one day of lodging) of $150, totaling $500 in 2005 dollars.
    The estimated total annual examinee time and travel costs provided 
in Table 3 are for a national base population using the number of 
examinees in 2005 (12,831) as broken down in Table 1 for the existing 
regulation, and one-half the number of examinees for the proposed 
change. For the first and second tests, the applicable number of 
examinees is multiplied by test time as detailed in this section for 
the 10- and 20-challenge tests, respectively, and the corresponding 
hourly compensation assumptions for cytotechnologists and pathologists 
in Table 2. For the third and fourth tests, the applicable number of 
examinees is multiplied by travel expenses ($500) and 16 hours (2 days) 
for test and travel time as described in this section, with the latter 
also multiplied by the corresponding hourly compensation assumptions in 
Table 2. It is assumed that these total national estimates apply to all 
laboratories, and that only laboratories directly bear the examinee 
time and travel costs by compensating examinees (their employees) for 
their test and travel time, and paying either their employee's or the 
program-supplied proctor's travel expenses. We note that neither 
examinees nor the PT programs are assumed to bear these costs.

         Table 3--Estimated Total Annual Examinee Time and Travel Costs of Cytology Proficiency Testing
                                                 [2005 dollars]
----------------------------------------------------------------------------------------------------------------
      Estimated total annual examinee time and travel costs of cytology proficiency testing (2005 dollars)
-----------------------------------------------------------------------------------------------------------------
                                                    Existing regulation  annual   Proposed change  testing every
                                                  testing/10 challenge first and    other year/all 20 cytology
                                                    second tests; 20 challenge            challenge tests
                                                      third and fourth tests     -------------------------------
                                                 --------------------------------
                                                        Low            High             Low            High
----------------------------------------------------------------------------------------------------------------
First Test......................................        $438,877      $2,042,583        $438,907      $2,042,819
Second Test.....................................          40,268         200,430          40,334         200,751
Third Test......................................          81,974         127,457          40,808          63,128
Fourth Test.....................................           5,775           9,537           2,887           4,769
                                                 ---------------------------------------------------------------
    Total.......................................         566,893       2,380,008         522,936       2,311,467
----------------------------------------------------------------------------------------------------------------
Note: The differences are due to rounding the numbers of examinees and dollar amounts to whole numbers.

g. Lost Work Days
    Under both the existing regulation and the proposed changes, 
individuals who do not pass the second test are required to have all 
their slides rescreened until they pass the subsequent test, and those 
who do not pass the third test are to cease examining gynecologic 
cytology specimens. It is assumed that 20 work days are lost by 
individuals taking the third test between the second and third tests, 
and that an additional 20 work days are lost by individuals taking the 
fourth test between the third and fourth tests due to these 
requirements. For those taking the fourth test, an additional 5 work 
days are lost due to training requirements in the existing regulation 
for examinees scoring less than 90 percent on the third test. 
Insufficient information is available to estimate training costs. 
However, under the current regulations, individuals failing the third 
or fourth test or both are experiencing these lost work days.
    The estimated total annual cost of lost work days as described in 
this section is provided in Table 4. These are national total estimates 
for all third and fourth test examinees for the existing regulation 
(see Table 1 for breakdown of the 2005 examinees used as the base 
population), and one-half the number of examinees for the proposed 
change. As described in this section, estimated lost work days 
associated with rescreening are 20 8-hour days (160 hours) for each 
third and fourth test examinee. The hours per examinee are multiplied 
by the applicable number of national examinees and the corresponding 
hourly compensation assumptions for cytotechnologists and pathologists 
in Table 2. It is assumed that these total national estimates apply to 
all laboratories, and that only laboratories directly bear the cost of 
lost work days by compensating examinees (their employees) for these 
days. We note that neither examinees nor the PT programs are assumed to 
bear these costs.

[[Page 3287]]



            Table 4--Estimated Total Annual Costs of Lost Work Days for Cytology Proficiency Testing
                                                 [2005 dollars]
----------------------------------------------------------------------------------------------------------------
         Estimated total annual costs of lost work days for cytology proficiency testing (2005 dollars)
-----------------------------------------------------------------------------------------------------------------
                                                    Existing regulation  annual   Proposed change  testing every
                                                  testing/10 challenge first and    other year/all 20 cytology
                                                    second tests; 20 challenge            challenge tests
                                                      third and fourth tests     -------------------------------
                                                 --------------------------------
                                                        Low            High             Low            High
----------------------------------------------------------------------------------------------------------------
Third Test......................................        $519,741        $974,571        $258,083        $481,285
Fourth Test.....................................          37,747          75,373          18,874          37,686
                                                 ---------------------------------------------------------------
    Total.......................................         557,488       1,049,944         276,957         518,971
----------------------------------------------------------------------------------------------------------------

h. Proctor Time
    Proctors are used for each testing event, with the amount of 
proctor time required including pre-test, test, and post-test time. 
Proctors are assumed to be cytotechnologists. Since cytotechnologists 
serving as proctors are not available for other work, this lost time is 
a cost. The following assumptions are used to estimate proctor time per 
examinee. Combined pre-test and post-test proctor time per test-taker 
is assumed to range from a low of 30 minutes to a high of 1 hour under 
both the existing regulation and the proposed rule. Proctor test time 
per examinee is directly related to the number of examinees per 
proctor. The range for this ratio is assumed to vary from one to five 
examinees per proctor. (ASCP GYN PT 2007 Enrollment Booklet (accessed 
May 2007) http://ascp.-org/proficiencyTesting/pdf/2007enrollment--
PT.pdf and 2007 CAP PAP PT Program General Information Booklet 
(accessed January 2008) http://www.cap.org/apps/docs/proficiency_testing/pap_pt/2008_pap_pt_program_information.pdf).
i. 10 Challenge Test
    Applying the one to five range of examinees to a single proctor to 
the examinee time assumptions for the 10 challenge test of 1 to 2 hours 
for cytotechnologists and pathologists without cytotechnologists, the 
proctor test time per examinee ranges from 12 minutes to 2 hours, and 
for pathologists with cytotechnologists (examinee time of 30 minutes to 
2 hours), the proctor test time per examinee ranges from 6 minutes to 2 
hours. Adding the proctor time per examinee combined pre-test and post-
test assumptions (30 minutes to 1 hour) to the proctor time per 
examinee test time estimates results in a total proctor time per 
examinee range of 42 minutes to 3 hours for cytotechnologists and 
pathologists, and a range of 36 minutes to 3 hours for pathologists 
with cytotechnologists.
j. 20 Challenge Test
    Applying the one to five range of examinees to a single proctor to 
the examinee time assumptions for the 20 challenge test of 2 to 4 hours 
for cytotechnologists and pathologists without cytotechnologists, the 
proctor test time per examinee ranges from 24 minutes to 4 hours, and 
for pathologists with cytotechnologists (examinee time range 1 hour to 
4 hours), the proctor test time per examinee ranges from 12 minutes to 
4 hours. Adding the proctor time per examinee combined pre-test and 
post-test assumptions (30 minutes to 1 hour) to the proctor time per 
examinee test time estimates results in a total proctor time per 
examinee range of 54 minutes to 5 hours for cytotechnologists and 
pathologists, and a range of 42 minutes to 5 hours for pathologists 
with cytotechnologists.
    The estimated total annual proctor time costs as described in this 
section are provided in Table 5. These are national total estimates for 
all examinees for the existing regulation (see Table 1 for base 
population) and one-half the number of examinees for the proposed 
change. Using the ranges stated in this section for the combined 
proctor pre- and post-test time, and the test time per examinee for the 
10- and 20-challenge tests, respectively, these ranges are multiplied 
by the number of total examinees and the proctor (cytotechnologist) 
hourly total compensation assumptions (Table 2) to estimate the high 
and low total national annual proctor costs. It is assumed that these 
total national estimates for the first tests apply to all laboratories, 
and that only laboratories directly bear the proctor time costs by 
compensating proctors (their employees) for this time. It is assumed 
that the total national estimates for proctor time costs for the 
second, third, and fourth tests apply to all laboratories with 
examinees who are required to participate in repeat testing. For the 
second test, the laboratories would directly bear the proctor time 
costs as described above. For the third and fourth tests, the PT 
programs would directly bear these proctor time costs by compensating 
proctors (their employees). Hence, examinees are not assumed to bear 
these proctor time costs; PT programs do not bear proctor time costs of 
the first and second tests; and laboratories do not bear proctor time 
costs of the third and fourth tests.

[[Page 3288]]



               Table 5--Estimated Total Annual Proctor Time Costs for Cytology Proficiency Testing
                                                 [2005 dollars]
----------------------------------------------------------------------------------------------------------------
            Estimated total annual proctor time costs for cytology proficiency testing (2005 dollars)
-----------------------------------------------------------------------------------------------------------------
                                                    Existing regulation  annual   Proposed change  testing every
                                                  testing/10 challenge first and    other year/all 20 cytology
                                                    second tests; 20 challenge            challenge tests
                                                      third and fourth tests     -------------------------------
                                                 --------------------------------
                                                        Low            High             Low            High
----------------------------------------------------------------------------------------------------------------
First Test......................................        $307,717      $1,645,961        $190,198      $1,371,741
Second Test.....................................          26,875         144,700          16,572         120,797
Third Test......................................           1,979          12,828             989           6,414
Fourth Test.....................................             132             855              66             428
                                                 ---------------------------------------------------------------
    Total.......................................         336,703       1,804,344         207,826       1,499,379
----------------------------------------------------------------------------------------------------------------

k. Packaging and Shipping Costs
    For each test under both the existing regulation and the proposed 
changes, packaging and shipping costs for each slide set are assumed to 
range from a low of $5 to a high of $20 for the first test, and from a 
low of $15 to a high of $30 for the second test (PT program meeting, 
August 2006). No packaging and shipping costs are used for the third 
and fourth tests because of the assumption that off-site testing will 
occur at PT program locations.
    The estimated total annual shipping and packaging costs as 
described in this section are provided in Table 6. These are national 
total estimates apply to all examinees for the existing regulation (see 
Table 1 for base population), and one-half the number of examinees for 
the proposed change. It is assumed that PT programs directly bear the 
costs for shipping and packaging. We note that neither laboratories nor 
examinees are assumed to bear these costs.

          Table 6--Estimated Total Annual Shipping And Packaging Costs of Cytology Proficiency Testing
                                                 [2005 dollars]
----------------------------------------------------------------------------------------------------------------
       Estimated total annual shipping and packaging costs of cytology proficiency testing (2005 dollars)
-----------------------------------------------------------------------------------------------------------------
                                                                 Existing regulation    Proposed change  testing
                                                                  annual testing/10      every other year/all 20
                                                                 challenge first and    cytology challenge tests
                                                                    second tests       -------------------------
                                                             --------------------------
                                                                  Low          High         Low          High
----------------------------------------------------------------------------------------------------------------
First Test..................................................      $64,155     $256,620      $32,080     $128,320
Second Test.................................................       16,920       33,840        8,475       16,950
                                                             ---------------------------------------------------
    Total...................................................       81,075      290,460       40,555      145,270
----------------------------------------------------------------------------------------------------------------

    Using the assumptions stated above, the estimated total annual 
testing costs in 2005 dollars are provided in Table 7 below.

                      Table 7--Estimated Total Annual Costs of Cytology Proficiency Testing
                                                 [2005 dollars]
----------------------------------------------------------------------------------------------------------------
                   Estimated total annual costs of cytology proficiency testing (2005 dollars)
-----------------------------------------------------------------------------------------------------------------
                                                    Existing regulation  annual   Proposed change  testing every
                                                  testing/10 challenge first and    other year/all 20 cytology
                                                    second tests; 20 challenge            challenge tests
                                                      third and fourth tests     -------------------------------
                                                 --------------------------------
                                                        Low            High             Low            High
----------------------------------------------------------------------------------------------------------------
First Test......................................        $810,749      $3,945,164        $661,185      $3,542,879
Second Test.....................................          84,063         378,970          65,381         338,498
Third Test......................................         603,693       1,114,856         299,881         550,827
Fourth Test.....................................          43,654          85,765          21,827          42,883
                                                 ---------------------------------------------------------------
    Total.......................................       1,542,160       5,524,756       1,048,274       4,475,088
----------------------------------------------------------------------------------------------------------------


[[Page 3289]]

    The national total annualized impact for all examinees in all 
laboratories of the monetized costs for the proposed changes compared 
to the existing regulation based on the estimates in Table 7 is a cost 
savings. The range of estimated savings is projected by taking the 
difference in the Table 7 total low and high estimates, respectively, 
between the existing regulation and the proposed changes. The estimated 
annual impact of the proposed changes ranges from a minimum savings of 
$493,886 (the difference in the low estimates) to a maximum savings of 
$1,049,668 (the difference in the high estimates) in 2005 dollars. Of 
the total estimated cost savings, the savings to PT programs ranges 
from a minimum of $41,575 to a maximum of $152,032, with the remainder 
of the estimated total savings to laboratories, and no estimated impact 
on examinees.
l. Non-Quantifiable Impacts
    Expand test medium options to allow other potential media for 
example, computer-based virtual slides or alternative testing formats, 
in addition to glass slide challenges.
Rationale
    Implementation of cytology PT on a national level was significantly 
delayed following the 1994 effective date required by the February 28, 
1992 final rule with comment because no PT program requested CMS 
approval. The Maryland Cytology Proficiency Testing Program (MCPTP) was 
approved to initiate testing in 1995, but PT under that program is 
limited to those cytologists who examine cytology preparations from 
Maryland residents. In 2004, the Midwest Institute for Medical 
Education (MIME), the first national cytology PT program, was approved. 
Delay in implementation was largely due to the perception that 
providing a sufficient quantity of good quality glass slide 
preparations, as required at Sec.  493.945(a), for use in testing would 
be burdensome to collect, reference, validate and maintain. The life 
cycle of glass slide preparations is somewhat limited due to stain 
fading, slide breakage, or loss. For some methods of liquid-based 
preparations, slides are typically usable for no more than 2 years, 
inclusive of time spent collecting, referencing, and validating. One 
way to expand the life cycle of a glass slide would be to capture a 
digital image of the slide preparations as a ``virtual slide,'' usable 
indefinitely, and thus requiring fewer slides for PT. Other computer-
based test media may become available as technology advances. 
Therefore, in defining a cytology challenge, for PT purposes, we are 
proposing to permit the use of computer-based virtual slides or other 
CMS-approved media, in addition to traditional glass slides, expanding 
the options for PT programs. We anticipate that by providing 
flexibility for alternatives to glass slides this change could 
encourage the development and use of other media and testing formats.
Potential Impact
    As technology for gynecologic cytology testing continues to evolve, 
we anticipate that the cost of PT programs that use virtual slides or 
other imaging technology would be less than glass slide programs, in 
spite of the initial implementation costs for equipment to produce 
virtual slides or other types of images or materials. Developmental 
costs for alternative formats may be offset by the decreased number of 
slides or other testing materials that would be needed, their 
validation and maintenance costs, and the costs associated with test 
delivery. However, data for estimating these costs are unavailable. A 
potential benefit of computer-based PT is that the test challenges are 
stable and uniform throughout testing events and to individuals being 
tested.
m. Eliminate the Requirement for Tissue Biopsy Confirmation of Response 
Category C (LSIL) Cytology Challenges
Rationale
    Current requirements at Sec.  493.945(b)(1) specify biopsy 
confirmation of premalignant and malignant challenges, which would 
include challenges in LSIL (Category C) response and Category D (HSIL 
or cancer). This requires PT programs to obtain sufficient numbers of 
slides if they meet the diagnostic criteria for these response 
categories and have confirmatory histologic specimen reports. Although 
patients with LSIL (Category C) and HSIL or cancer (Category D) are 
both referred for colposcopy, LSIL (Category C) lesions may be 
transient and regress in the interval between the time the Pap smear 
specimen is taken and the time of colposcopic biopsy. There are 
instances of LSIL (Category C) lesions that may not be confirmed by 
tissue biopsy. Continuing to require biopsy confirmation for LSIL 
(Category C) challenges would make it more difficult for PT programs to 
continue to find sufficient numbers of LSIL (Category C) challenges. In 
addition, it is proposed that all cytology challenges be field 
validated. This validation would confirm and strengthen the 
reproducible nature of LSIL (Category C) cytology challenges, and serve 
the same purpose as biopsy confirmation.
Potential Impact
    Removal of this requirement should make it easier for PT programs 
to obtain cytology challenges in the response Category C (LSIL) and 
result in a cost savings. These savings are not quantifiable since 
challenges are currently donated and the cost for each laboratory to 
provide assurances that biopsy confirmation has been done has not been 
captured. These costs would vary by laboratory on the basis of the ease 
of use of its record-tracking system and the number of LSIL (Category 
C) cytology challenges it donates to a PT program.
n. Modifications to the Scoring Scheme
Rationale
    The proposed scoring scheme maintains the same four response 
categories as in the current rule with changes to the scores for 
certain responses. These changes include two specific score changes in 
the technical supervisor (pathologist) scheme and six changes for 
cytotechnologist scoring that can be grouped in three categories, as 
described below. The only difference between the two proposed schemes 
is that technical supervisors receive partial credit (2.5 points) for 
misclassifying response Category C (LSIL) as response Category D (HSIL 
or cancer) and response Category D (HSIL or cancer) as response 
Category C (LSIL) while cytotechnologists receive full credit (5 
points).
o. Scoring Changes for False Positives (Over Reporting)
    Eliminating partial credit to the cytotechnologist when over 
reporting response Categories A (Unsatisfactory) and response Category 
B (Normal or Benign Changes) as response Category C (LSIL) or response 
Category D (HSIL or cancer) lessens the asymmetry in the scheme whereby 
false positives are currently given less punitive weight than false 
negatives. Although this change will effectively change the point 
values in the four boxes in the upper right hand quadrant of the 
scoring scheme table, it is addressed here as one change. It is 
expected that cytotechnologists would be able to differentiate these 
categories in their normal daily practice, and by awarding partial 
credit for making errors on the test, cytotechnologists might be prone 
to report results toward the positive side when they would not normally 
do so in practice. The current scheme, therefore, provides more 
opportunities for

[[Page 3290]]

cytotechnologists to manipulate the test system by over reporting to 
obtain a favorable score. The proposed scheme will more closely 
correspond to routine practice in which cytotechnologists report 
unsatisfactory and negative results.
p. Removal of Partial Credit for Miscalling LSIL as Unsatisfactory
    A second proposed change for both scoring schemes (technical 
supervisors and cytotechnologists) is the removal of partial credit for 
reporting response Category A (Unsatisfactory) for a response Category 
C (LSIL) cytology challenge. The rationale for this change is that an 
LSIL (Category C) cytology challenge is easily differentiated from an 
unsatisfactory cytology challenge and individuals should, therefore, be 
able to make this determination. In addition, as described above for 
making false positive calls, allowing partial credit for reporting an 
LSIL (Category C) challenge as an unsatisfactory challenge provides an 
incentive for examinees to report unsatisfactory slides when in doubt. 
A slide miscalled as unsatisfactory in practice leads to unnecessary 
repeat testing.
q. Reduced Penalty for False Negatives (Under Reporting)
    The proposed change to reduce the penalty score for reporting 
response Category B (Normal or Benign Changes) for a response Category 
D (HSIL or cancer) is made on the basis of a number of comments from 
professional organizations and recommendations from the CLIAC that 
suggest the current scheme is overly punitive. If finalized, this 
change will affect the sequence of events for retesting and remediation 
for individuals found to have questionable proficiency in this area. In 
the current rule, on a 10 slide test, one misclassification of a 
response Category D (HSIL or cancer) challenge as response Category B 
(Normal or Benign Changes) will result in a score of less than 90 
percent and a 10 slide retest within 45 days. If the individual passes 
the retest there are no additional consequences.
    If the same misdiagnosis is made on the second 10 slide retest, 
remediation, rescreening and a 20 slide retest will follow. In the 
proposed scheme, on a test with 20 cytology challenges that must 
include at least two cytology challenges in response Category D (HSIL 
or cancer), if an individual miscalls one of the HSIL or cancer 
(Category D) cytology challenges as normal or benign changes and makes 
no other errors, he or she will pass the test. With two misses of HSIL 
or cancer (Category D) on the proposed 20 cytology challenge test, the 
individual will score less than 90 percent and will be subject to a 20 
cytology challenge retest. In summary, the current rule allows for two 
opportunities to miss an HSIL or cancer (Category D) on a total of 20 
slides (given as 10 slide tests in two testing events) before 
rescreening is initiated. In the proposed rule, two misses of HSIL or 
cancer (Category D) on 20 slides (in one testing event) results in a 
retest. (Missing one HSIL or cancer (Category D) cytology challenge 
results in a passing score). Rescreening of patient specimens would be 
initiated in the proposed scheme if an individual missed four HSIL or 
cancer (Category D) cytology challenges on a total of 40 cytology 
challenges in two PT events, assuming no other errors were made. A 
comparison between the current and proposed rule for this one type of 
false negative error is depicted in Table 3 below.

                       Table 8--Comparison of Current and Proposed Rule Testing Sequences
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                         Current rule                    Proposed rule
----------------------------------------------------------------------------------------------------------------
1st test: 10 challenges..............  one miss* = 85 percent   1st test: 20 cytology    one miss* = 90 percent--
                                        (one miss on 10          challenges.              pass.
                                        challenges).                                     two missed* = 80
                                                                                          percent (two misses on
                                                                                          20 cytology
                                                                                          challenges).
----------------------------------------------------------------------------------------------------------------
                                                 45 days--retest
----------------------------------------------------------------------------------------------------------------
2nd test: 10 challenges..............  one miss* = 85 percent   2nd test: 20 cytology    one miss* = 90 percent.
                                        (equivalent to 2         challenges.             two missed* = 80
                                        misses* on 20                                     percent (4 misses* on
                                        challenges).                                      40 cytology
                                                                                          challenges).
----------------------------------------------------------------------------------------------------------------
                              Remedial training on identification of HSIL OR Cancer
                                              All slides rescreened
                                                     Retest
----------------------------------------------------------------------------------------------------------------
3rd test: 20 challenges..............  one miss* = 80 percent.  3rd test: 20 cytology    two missed* = 80
                                                                 challenges.              percent.
----------------------------------------------------------------------------------------------------------------
                                             Cease slide examination
                                          35 hours of remedial training
                                         Pass 20 cytology challenge test
----------------------------------------------------------------------------------------------------------------
Note to Reader: * miss = Reporting response Category B (normal or benign changes) for response Category D (HSIL
  or cancer).

    Potential Impact:
    Overall pass rates:
    The proposed scoring scheme incorporating all of the changes 
described above, designed to be applied to a 20 cytology challenge 
test, cannot be directly compared to the current scheme with 10 
challenges due to the differences in point values. The proposed scheme 
is more stringent in some areas (cytotechnologists scoring) and less 
stringent in others (pathologists scoring). We are uncertain whether 
these changes, coupled with the increase in the number of cytology 
challenges, would have any impact on the overall pass rates. The 
increase in cytology challenges should increase test sensitivity, while 
the scoring scheme changes may make the test more difficult to ``second 
guess'' but more easily passed for those pathologists unable to 
correctly identify HSIL or cancer (Category D). For the purposes of 
calculating costs attributed to retesting and remediation for the 
proposed rule, we have assumed the pass rates would not change.

[[Page 3291]]

r. Administrative Changes for Which Impact Would Be Negligible
    In the process of approving and operating gynecologic cytology PT 
programs, certain administrative practices have been developed and are 
followed by PT programs, and laboratories as part of the program 
operations. CLIAC, PT programs, and professional organizations 
recommended incorporating these practices into the regulation to ensure 
that they are consistently met by all PT programs and laboratories. 
However, since these practices are generally part of the process at 
this time, we anticipate no measurable impact if they are adopted as 
requirements.
    Written agreements: As specified at Sec.  493.945(b)(6), the PT 
program must provide a written agreement to be signed by the laboratory 
director accepting responsibility for test administration should be of 
minimal impact to the PT programs and the laboratory director, since 
under Sec.  493.853(b), the laboratory director must now ensure that 
individuals participate in on-site PT. In addition, requiring the 
laboratory to identify all individuals who perform gynecologic cytology 
examinations to CMS and PT programs, as proposed at Sec.  
493.853(a)(2), would have a minimal impact on laboratories, since this 
information is already provided when the laboratory enrolls in a PT 
program. It is not possible to calculate the minor impact of these 
changes to the requirements.
    Proctor Training: As proposed at Sec.  493.853(b)(4) and Sec.  
493.945(b)(5), the proctor training and examination requirements, as 
well as the proctor responsibility for test administration would have a 
negligible impact as PT programs may use laboratory-designated proctors 
to conduct testing, and the proctors must be trained, capable of test 
administration, and tested to assure competency. The resultant score of 
``zero'' for all individuals in the laboratory if the proctor does not 
appropriately administer the testing event could impact laboratories, 
and lead to required remediation and limitation of slide examinations, 
if individuals are not retested or do not pass a subsequent 
examination. However, it is not possible to project whether this 
potential change would increase cost, but it is not expected to be 
significant since adequate proctor training and appropriate test 
administration are now part of PT program operations.
    Bethesda 2001 Terminology: We propose changing the description of 
the response Category A (Unsatisfactory) to match the current Bethesda 
2001 Terminology. We do not anticipate that it would have a measurable 
impact on the overall cost of the program.
    Inclusion of at least two HSIL or cancer cytology challenges per 
test: As required at Sec.  493.945(b)(1)(ii), including a minimum of 
two response Category D (HSIL or cancer) cytology challenges in a 20 
cytology challenge test would be equivalent to requiring at least one 
response Category D (HSIL or cancer) cytology challenge in a 10 slide 
test set (currently at Sec.  493.945 (a)(1)). This change should have 
little or no impact as long as the number of required cytology 
challenges per testing event is doubled.
    Continuous Validation of Cytology Challenges: Requiring PT programs 
to provide continuous validation of cytology challenges throughout 
their use in testing is currently a routine practice conducted by the 
three CMS-approved PT programs. This revision, proposed at Sec.  
493.945(c)(1)(ii), should not have an impact if required, and would 
ensure that cytology challenges maintain their acceptability for use in 
testing.
    Appeals: The proposed rule specifies at Sec.  493.945(b)(4) that PT 
programs would provide their appeals process in writing to all enrolled 
individuals. This change would have a minimal impact on program costs, 
since it could be done electronically or added to enrollment forms or 
other materials provided to each individual before their participation 
in a PT event.

C. Alternatives Considered

    Because the proposed revisions to the gynecologic cytology PT 
requirements are interdependent, alternatives to each proposed change 
can not be considered separately without having an effect on the total 
process. Therefore, it is necessary to take these complexities into 
account when considering alternatives to the changes that are proposed.
    For expansion of the test medium used, we considered maintaining 
the current requirement for glass slide challenges. However, the lack 
of adequate numbers of glass slides for a national PT program is the 
reason for the lengthy delay in national cytology PT implementation. 
Allowing other potential media would provide flexibility for future 
technology and accommodation of all individuals who need to be tested. 
In addition, to ensure continued testing of workplace performance, as 
more laboratories use computer-assisted screening, the regulations 
would need to be expanded to allow other types of challenges.
    We considered testing frequencies less often than once every 2 
years, but decided against incorporating a frequency of once every 3 
years (recommended by CLIAC) or longer (recommended by some cytology 
professional organizations) due to concern that less frequent testing 
may allow poor performers to go undetected for a longer period of time. 
After agreeing to propose a testing frequency of at least once every 2 
years, we also considered keeping the required number of ten challenges 
per event. However, this may also decrease the ability of the test to 
identify poor performers.
    In determining the appropriate number of cytology challenges per 
testing event, we considered including more than 20, but we were unable 
to identify reliable data showing that the additional benefits for 
testing with a greater number of slides support the additional costs 
and resources that would be required. Also, as noted above, finding 
enough acceptable slides for testing was the primary cause for the 
delay in implementation of cytology PT and greatly increasing the 
number of challenges in each test could potentially produce a similar 
effect.
    In looking at the total number of cytology challenges per event, we 
propose to increase the required number of response Category D (HSIL or 
cancer) cytology challenges from at least one in a 10 challenge test to 
at least two in a 20 cytology challenge test, and we considered whether 
requiring fewer or more of these challenges would be appropriate. 
However, we concluded that requiring at least two response Category D 
(HSIL or cancer) cytology challenges would be comparable with requiring 
at least one on a 10 challenge test, and data do not indicate this to 
be a problem.
    Several alternatives were considered for revisions to the scoring 
scheme. The organizations provided variations on the scoring scheme and 
several other variations were suggested by the CLIAC workgroup to the 
CLIAC committee. CLIAC was presented with a data comparison of the 
various schemes. The schemes did not produce a wide variation in the 
number of individuals passing the testing event, so the CLIAC concluded 
that the scheme chosen should be reflective of normal work performance. 
Therefore, we believe the grading scheme proposed provides a greater 
balance between the identification of false positives and the 
identification of false negatives.
    The only alternative to eliminating tissue biopsy confirmation of 
response Category C (LSIL) would be to continue to require this 
confirmation. The

[[Page 3292]]

feedback from the professional organizations and CLIAC was that this 
requirement eliminated potential challenges due to the current practice 
where patients with this diagnosis may not receive a biopsy for 
confirmation. Therefore, we are proposing to eliminate this 
requirement.
    For the minor administrative changes that are being proposed, the 
only alternatives considered were to not make these changes. However, 
since the changes would standardize practices that are already in place 
among PT programs and laboratories, it seems reasonable to specify 
these practices in the appropriate sections of the regulation to ensure 
that they continue to be met by all as part of the PT process.

D. Conclusion

    For these reasons, we are not preparing analyses for either the RFA 
or section 1102(b) of the Act because we have determined that this rule 
would 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.

List of Subjects in 42 CFR Part 493

    Administrative practice and procedure, Grant programs--health, 
Health facilities, Laboratories, Medicaid, Medicare, Penalties, 
Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth 
below:

PART 493--LABORATORY REQUIREMENTS

    1. The authority citation for part 493 continues to read as 
follows:

    Authority: Secs. 353 of the Public Health Service Act, secs. 
1102, 1861(e), the sentence following sections 1861(s)(11) through 
1861 (5)(16) of the Social Security Act (42 U.S.C. 263a, 1302, 
1395x(e),the sentence following 1395x(s)(11)through 1395x(s)(16).

Subpart A--General Provisions

    2. Section 493.2 is amended by--
    A. Revising the definition of ``Challenge.''
    B. Adding the definition of ``Cytology challenge'' in alphabetical 
order.
    C. Revising paragraph (4) of the definition ``Unsuccessful 
participation in proficiency testing.''
    The revisions and additions read as follows:


Sec.  493.2  Definitions.

* * * * *
    Challenge means, for quantitative tests, an assessment of the 
amount of substance or analyte present or measured in a sample. For 
qualitative tests, a challenge means the determination of the presence 
or the absence of an analyte, organism, or substance in a sample. For 
cytology see the definition of ``Cytology challenge.''
* * * * *
    Cytology challenge means a sample consisting of gynecologic 
cytology material that is used to evaluate the individual's locator and 
identification skills. Cytology challenge material may include glass 
slides, digital images, or other CMS approved testing media.
* * * * *
    Unsuccessful participation in proficiency testing * * *
* * * * *
    (4) Failure of a laboratory performing gynecologic cytology to meet 
the standard at Sec.  493.853.
* * * * *

Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Nonwaived Testing

    3. Section 493.803 is amended by--
    A. Revising paragraph (b).
    B. Redesignating paragraph (c) as paragraph (d).
    C. Adding a new paragraph (c).
    The revisions and addition read as follows:


Sec.  493.803  Condition: Successful participation.

* * * * *
    (b) Except as specified in paragraph (d) of this section, CMS 
imposes sanctions as specified in subpart R of this part when a 
laboratory fails to participate successfully in proficiency testing for 
a given specialty, subspecialty, analyte, or test as defined in this 
section.
    (c) For gynecologic cytology, CMS imposes sanctions as specified in 
subpart R of this part when a laboratory fails to ensure that each 
individual performing gynecologic specimen examinations--
    (1) Is enrolled in a CMS approved cytology proficiency testing 
program;
    (2) Participates successfully in gynecologic cytology proficiency 
testing at least every 2 years; and
    (3) Takes the applicable remedial action as described in Sec.  
493.853(c) when scoring less than 90 percent on gynecologic cytology 
proficiency testing.
* * * * *
    4. Section 493.853 is revised to read as follows:


Sec.  493.853  Condition: Cytology: gynecologic specimen examinations.

    To participate successfully in a cytology proficiency testing 
program for gynecologic specimen examinations (Pap smears), the 
laboratory must meet the requirements for an individual's enrollment, 
participation, and remediation as specified in paragraphs (a) through 
(c) of this section.
    (a) Enrollment. The laboratory must--
    (1) Ensure that each individual performing gynecologic specimen 
examinations is enrolled in a gynecologic cytology proficiency testing 
program approved by CMS; and
    (2) Provide the proficiency testing program and CMS with the 
information specified by CMS that is necessary to identify all 
individuals performing gynecologic specimen examinations.
    (b) Participation. The laboratory must ensure that--
    (1) Each individual performing gynecologic specimen examinations is 
initially tested on-site in the laboratory on an announced or 
unannounced basis at least once every 2 calendar years;
    (2) Each individual is notified of the date, time, and location of 
each announced testing;
    (3) Each individual attains a score of at least 90 percent on each 
testing event and, if applicable, participates in remediation as 
specified in paragraph (c) of this section;
    (i) An individual with an unexcused absence will receive a score of 
``zero;''
    (ii) For an individual with an excused absence, the laboratory must 
contact the proficiency testing program to determine the date, time, 
and location of the make-up examination;
    (4) For on-site testing, if the laboratory chooses to designate a 
proctor, rather than have the proficiency testing program administer 
the test, the laboratory must ensure the testing event is properly 
administered as specified in this section. Any inappropriately 
administered testing event will result in a ``zero'' score for all 
participants. The laboratory is responsible for ensuring--
    (i) All proctors successfully complete the proctor examination 
before administering the testing event;
    (ii) The proctor follows the proficiency testing program's 
requirements for testing;
    (iii) Each individual is tested independently, except as provided 
at Sec.  493.945(c)(2);
    (iv) Resources capable of assisting the individual in slide 
interpretation, including text books or electronic media, are not 
allowed in the testing area;

[[Page 3293]]

    (v) All materials and results are kept confidential before, during, 
and after testing; and
    (vi) Testing materials, including but not limited to glass slides, 
images, and test result sheets are not reproduced.
    (c) Remediation. The laboratory must ensure that each individual 
who scores less than 90 percent on a testing event completes the 
required remediation and is retested within 45 days after completion of 
the remediation. If an individual scores less than 90 percent on:
    (1) An initial test, the individual must be retested not more than 
45 days after receipt of notification of his or her score.
    (2) A second test (first retest), the individual must--
    (i) Obtain documented remedial training and education in the area 
of deficiency;
    (ii) Have all gynecologic preparations evaluated subsequent to the 
notification of the second test score reexamined by an individual who 
has successfully participated in a CMS approved proficiency testing 
event during the current 2 year cycle. Reexamination of gynecologic 
preparations must be documented.
    (iii) Be retested within 45 days after completion of the 
remediation.
    (3) A third test or any subsequent retest, the individual must--
    (i) Obtain at least 35 hours of documented, continuing education in 
gynecologic cytology that focuses on the incorrect response categories; 
and
    (ii) Discontinue examining gynecologic preparations immediately 
upon notification of a score of less than 90 percent and not resume 
examining gynecologic preparations until the individual obtains a score 
of at least 90 percent on a retest.
    (iii) Be retested within 45 days after completion of the 
remediation.


Sec.  493.855  [Removed and Reserved]

    5. Section 493.855 is removed and reserved.

Subpart I--Proficiency Testing Programs for Nonwaived Testing

    6. Section 493.905 is revised to read as follows:


Sec.  493.905  Nonapproved proficiency testing programs.

    If a proficiency testing program is disapproved or denied approval 
by CMS, CMS will notify the program and the program must notify all 
enrolled laboratories of the nonapproval and the reason for the 
nonapproval within 30 days of notification. The program will be 
disapproved or denied approval if the program--
    (a) Fails to meet any criteria contained in Sec.  493.901 through 
Sec.  493.959 for approval of the proficiency testing program; or
    (b) Is determined by CMS to have submitted falsified information to 
obtain approval of the program.
    7. Section 493.945 is revised to read as follows:


Sec.  493.945  Cytology: Gynecologic examinations.

    To be approved for proficiency testing in gynecologic cytology, the 
program must meet the requirements specified in paragraphs (a) through 
(c) of this section.
    (a) Frequency of testing events. The program must provide:
    (1) An initial, on-site test at least once every 2 years on an 
announced or unannounced basis. For announced testing events, the 
program must notify the laboratory at least 30 days before the testing 
event of the location, date, and time of testing. However CMS has the 
authority to authorize alternative sites for testing.
    (2) A second test within 45 days after the laboratory is notified 
of an individual score of less than 90 percent on the initial testing 
event.
    (3) A third test and any subsequent retests within 45 days after 
completion of remediation as specified in Sec.  493.853(c)(2) and 
(c)(3). Any third test or subsequent retests must be administered by 
the proficiency testing program and may not be proctored by a 
laboratory designee.
    (b) Program description. The program must--
    (1) Provide test sets for each testing event composed of the 
following:
    (i) A minimum of 20 cytology challenges. Proficiency testing 
programs may obtain glass slides from a laboratory provided the glass 
slides have been retained by the laboratory for the required period 
specified in Sec.  493.1105(a)(7) and Sec.  493.1274(f)(2). If slides 
are still subject to retention by the laboratory, they may be loaned to 
a proficiency testing program if the program provides the laboratory 
with documentation of the loan of the slides and ensures that slides 
loaned to it are retrievable upon request.
    (ii) At least one cytology challenge representing response 
categories A, B, and C and at least two cytology challenges from 
response Category D for reporting proficiency testing results. The four 
response categories and their descriptions are as follows:

------------------------------------------------------------------------
         Response category                       Description
------------------------------------------------------------------------
A.................................  Unsatisfactory: Specimen processed
                                     and evaluated but unsatisfactory
                                     for evaluation of epithelial
                                     abnormality. These factors include
                                     minimum squamous cellularity
                                     (conventional smears and liquid-
                                     based preparations), absence of
                                     endocervial/transformation zone
                                     component, or obscuring factors
                                     (>75 percent of squamous cells
                                     obscured assuming no abnormal cells
                                     identified).
B.................................  Normal or Benign Changes includes:
                                       (1) Normal, negative or within
                                        normal limits.
                                       (2) Infection other than human
                                        papillomavirus (HPV) (for
                                        example, Trichomonas vaginalis,
                                        changes or morphology consistent
                                        with Candida spp., Actinomyces
                                        spp. or Herpes simplex virus).
                                       (3) Reactive and reparative
                                        changes (for example,
                                        inflammation, effects of
                                        chemotherapy or radiation).
C.................................  Low Grade Squamous Intraepithelial
                                     Lesion includes:
                                       (1) Cellular changes associated
                                        with HPV.
                                       (2) Mild dysplasia/CIN-1.
D.................................  High-Grade Lesion and Carcinoma
                                     includes:
                                       (1) High grade squamous
                                        intraepithelial lesions which
                                        include moderate dysplasia/CIN-2
                                        and severe dysplasia/carcinoma
                                        in-situ/CIN-3.
                                       (2) Squamous cell carcinoma.
                                       (3) Adenocarcinoma and other
                                        malignant neoplasms.
------------------------------------------------------------------------

    (2) Ensure individuals complete a 20 cytology challenge testing 
event within 4 hours.
    (3) Ensure that all 20 cytology challenge test sets provide for 
equitable testing among participants.
    (4) Provide a written description of the appeals process that is 
available to all individuals enrolled in the program.

[[Page 3294]]

    (5) Provide training for laboratory-designated proctors that 
includes--
    (i) Written instructions for the laboratory to determine the number 
of proctors needed to administer the proficiency testing event, 
including contingency for a backup proctor if needed;
    (ii) Written instructions for the laboratory director and proctor 
to ensure program procedures are fulfilled; and
    (iii) A proctor examination that evaluates the proctor's 
understanding of proper testing protocol.
    (6) Provide a written agreement, to be signed by the laboratory 
director and returned to the program before testing, stating the 
laboratory is responsible for and accepts responsibility for 
administering the proficiency testing as defined by the program and 
CMS.
    (c) Evaluation of an individual's performance. The program must--
    (1) Determine the accuracy of an individual's response on each 
cytology challenge by comparing the individual's response with the 
correct response specified by the four response categories listed in 
paragraph (b)(1)(ii) of this section. Determination of the correct 
response for each cytology challenge must include:
    (i) A 100 percent consensus agreement among a minimum of three 
physicians who meet the requirements of cytology technical supervisor 
(as specified in subpart M of this part) and examine gynecologic 
preparations on a routine basis.
    (ii) Continuous field validation of each cytology challenge by a 
method acceptable to CMS and that is disclosed to participants before 
enrollment in the program.
    (iii) Confirmation by tissue biopsy of all cytology challenges that 
have a correct response of Category D (HSIL or cancer) either by 
comparison of the reported biopsy results or reevaluation of biopsy 
slide material by a physician certified in anatomic pathology.
    (2) Test individuals qualified as cytology technical supervisors 
(as specified in subpart M of this part) under conditions comparable to 
their workplace performance in cytology. A cytology technical 
supervisor who routinely interprets gynecologic preparations that 
have--
    (i) Been previously examined by a cytotechnologist may participate 
in the testing event using either a test set that has not been 
previously screened or a test set selected at random that has been 
previously screened by a cytotechnologist who works in the same 
laboratory.
    (ii) Not been previously examined must be tested using a test set 
that has not been previously screened.
    (3) Adhere to the grading scheme as follows:
    (i) The individual's score for a testing event is determined by 
adding the point values achieved for each cytology challenge.
    (ii) The point values for a 20 cytology challenge test for a 
technical supervisor qualified under Sec.  493.1449(b) or (k) are:

----------------------------------------------------------------------------------------------------------------
                                                                  Technical supervisor examinee response
                    Correct response                     -------------------------------------------------------
                                                            A--UNSAT     B--NEGATIVE     C--LSIL       D--HSIL
----------------------------------------------------------------------------------------------------------------
A--UNSAT................................................           5             0             0             0
B--NEGATIVE.............................................           2.5           5             0             0
C--LSIL.................................................           0             0             5             2.5
D--HSIL.................................................           0            -5             2.5           5
----------------------------------------------------------------------------------------------------------------

    (iii) The point values for a 20 cytology challenge test for a 
cytotechnologist qualified under Sec.  493.1469 or Sec.  493.1483 are:

----------------------------------------------------------------------------------------------------------------
                                                                      Cytotechnologist examinee response
                      Correct response                      ----------------------------------------------------
                                                               A--UNSAT    B--NEGATIVE    C--LSIL      D--HSIL
----------------------------------------------------------------------------------------------------------------
A--UNSAT...................................................           5              0            0            0
B--NEGATIVE................................................           2.5            5            0            0
C--LSIL....................................................           0              0            5            5
D--HSIL....................................................           0             -5            5            5
----------------------------------------------------------------------------------------------------------------

Subpart M--Personnel for Nonwaived Testing


Sec.  493.1451  [Amended]

    8. In Sec.  493.1451(c)(5) the reference ``493.855'' is revised to 
read ``493.853.''

(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: November 13, 2007.
Julie Gerberding,
Director, Centers for Disease Control and Prevention.
    Dated: November 15, 2007.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Approved: October 9, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E9-804 Filed 1-15-09; 8:45 am]
BILLING CODE 4120-01-P