[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Proposed Rules]
[Pages 3264-3294]
From the Federal Register Online via the Government Publishing 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 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:
[[Page 3267]]
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
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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,
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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, [email protected] 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
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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