Medicare, Medicaid, and Clinical Laboratory Improvement Amendments of 1988 (CLIA) Program; Cytology Proficiency Testing (PT), 3264-3294 [E9-804]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[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

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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 https://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: https://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: https://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, https://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

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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 https://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 https://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