3264 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 

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. 

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, negativebenign, low grade squamous 

intraepithelial lesions, and high grade 

squamous intraepithelial lesions) as 

defined in § 493.945(b)(3)(ii)(A), and the 

test sets must be comparable to ensure 

equitable testing within and between PT 

programs. The programs are required to 

provide on-site testing for each 

individual enrolled at least once per 

year including announced and 

unannounced testing events, and must 

provide retesting for those individuals 

who fail any testing event. Technical 

supervisors (pathologists), who do not 

perform primary screening (that is, who 

only examine slides after they have been 

prescreened by a cytotechnologist) may 

be tested on slides that have been 

prescreened to locate potentially 

abnormal cells by a cytotechnologist 

who examines slides in their laboratory. 

There are separate scoring schemes for 

cytotechnologists and technical 

supervisors that award ¥5 to 10 points 

based on the proximity of the 

individual’s response to the correct 

response. Individuals receive a 

maximum of 10 points for every correct 

response. One provision requires 

deducting 5 points from an individual 

who responds that a slide is negative 

when the correct response is a high 

grade squamous intraepithelial lesion 

(HSIL) or cancer (Category D). (An HSIL 

or cancer (Category D) lesion is one that 

would require immediate follow-up and 

treatment due to its severity including: 

Moderate dysplasia, severe dysplasia, or 

carcinoma-in-situ or a cancer.) This 

individual would obtain a score of less 

than 90 percent even if every other slide 

in the test set was correctly identified 

resulting in test failure. In this case, the 

individual would score 90 points for 9 

correct responses and ¥5 points for 

incorrectly identifying an HSIL or 

cancer (Category D) as normal or benign. 

(The final score would be calculated by 

deducting 5 points from 90 points for a 

total of 85 points.) 

3. Response to Comments to the 

February 28, 1992 Final Rule With 

Comment 

Following publication of the February 

28, 1992 final rule with comment, we 

received nearly 300 comments on the 

cytology PT requirements. 

Approximately 90 comments addressed 

participation in cytology PT and over 

200 comments addressed the cytology 

PT programs. The majority of the 

commenters stated opposition to the 

cytology PT requirements, and voiced 

concern about the feasibility and costs 

associated with the development of a 

national glass slide PT program that 

included on-site testing of individuals. 

Some comments stated that national 

testing of individuals could not be 

achieved using glass slides. One 

organization suggested using media 

other than glass slides for testing. Other 

commenters were opposed to the 

frequency of annual testing, the 90 

percent passing score, inclusion of 

unsatisfactory in the response 

categories, and grading 

cytotechnologists in any manner other 

than based on their ability to separate 

unsatisfactory or negative categories 

from those requiring review by the 

technical supervisor. 

4. Final Rule Extending Cytology PT 

Enrollment Date 

As of January 1, 1994, (the enrollment 

deadline specified in the February 28, 

1992 final rule with comment), no 

cytology PT program had met the CLIA 

requirements for approval. On 

December 6, 1994, we published a final 

rule with comment (59 FR 62606) in the 

Federal Register, to allow additional 

time for programs to seek approval as a 

cytology PT provider, and to allow 

individuals an extension of the 

compliance date for enrollment in a 

CMS-approved cytology PT program. 

The December 6, 1994 final rule with 

comment changed the compliance date 

for cytology PT enrollment from January 

1, 1994 to January 1, 1995. Under that 

rule, enrollment was required by the 

compliance date if a CMS-approved 

program was available in the State in 

which the individual was employed. 

For individuals engaged in the 

examination of gynecologic cytology 

preparations who were employed in a 

State in which a CMS-approved 

cytology PT program was not available 

beginning January 1, 1995, enrollment 

and participation in a CMS-approved 

cytology PT program would be required 

at the point that a program became 

available. 

5. Litigation Regarding the February 28, 

1992 Regulations 

On January 14, 1993, the Consumer 

Federation of America and Public 

Citizen filed a lawsuit in the United 

States District Court for the District of 

Columbia (the Court), challenging the 

HHS implementation of CLIA 

(Consumer Federation of American and 

Public Citizen v. HHS, 906 F. Supp., 657 

(D. D.C. 1995), reversed in part and 

remanded in part). Among other things, 

plaintiffs argued that the cytology PT 

regulations violated the statutory 

mandate for cytology PT to ‘‘* * * take 

place, to the extent practicable, under 

normal working conditions, * * *’’ The 

plaintiffs’ suit indicated that the 

February 28, 1992 final rule with 

comment limited cytotechnologists to 

examining no more than 100 slides in a 

24 hour period, and that they must be 

allowed at least 8 hours to complete the 

examination of 100 slides. These 

provisions result in an average rate of 

review of 12.5 slides per hour. However, 

with respect to PT, the February 28, 

1992 final rule with comment included 

a lower slide examination rate of 5 

slides per hour (the 10 slide test was to 

be completed within 2 hours and the 20 

slide test was allotted 4 hours). 

On August 29, 1995, the Court ruled 

that the regulations did not strictly 

conform to the statutory mandate. The 

Court ordered HHS to engage in 

expedited rulemaking (within 90 days of 

its order), to publish a proposed rule in 

the Federal Register requesting public 

comment on the PT regulations for 

cytology personnel in light of 42 U.S.C. 

263a(f)(4)(B)(iv) (providing that 

individuals should be tested, to the 

extent practicable, under normal 

working conditions). The existing 

regulations were to remain in effect 

pending the issuance of a final rule as 

specified by the Court. 

In accordance with the Court’s order, 

on November 30, 1995, we published a 

proposed rule in the Federal Register 

(60 FR 61509). The rule proposed 

changing the provisions that authorized 

the examination of cytology PT slides at 

a rate of 5 slides per hour to a rate of 

12.5 slides per hour. In order to achieve 

this PT workload rate, the rule proposed 

changing the cytology PT 10 slide test’s 

duration from 2 hours to 45 minutes per 

testing event. The rule also proposed to 

limit the time for a 20 slide retest to 90 

minutes instead of 4 hours. The 

proposed rule stated that there might be 

other options for complying with the 

statutory mandate (providing that 

individuals should be tested, to the 

extent practicable, under normal 

working conditions), and specifically 

requested comments on options. 

We received approximately 760 

comments in response to the proposed 

rule from cytotechnologists, 

pathologists, professional organizations, 

and other members of the public. Nearly 

100 percent of the comments stated 

opposition to the proposed rate change. 

Commenters stated that PT differs from 

the working conditions associated with 

the examination of patient specimens; 

therefore, the time frame for a PT 

examination should not be equated to 

an individual’s workload rate. Reasons 

cited for opposing the proposed PT 

workload rate change included the 

following: 


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• Cytology PT requires screening a 

higher number of abnormal slides than 

is routinely seen in the patient 

workload. 

• The individual’s workload limit is a 

maximum rate and not a target rate. 

• The staining of PT slides may vary 

from the laboratories’ patient slides. 

• The individual screening rates 

differ. 

• The reporting format for PT results 

is different from the laboratory format. 

• There is more stress associated with 

PT. 

Approximately 350 comments were 

received in response to the proposed 

rule’s request for comments on 

expanding the CLIA provisions to 

permit the use of computer-based 

proficiency testing (CBPT) as an 

alternative to glass slide proficiency 

testing (GSPT). While a number of the 

comments indicated that individuals 

were apprehensive about a CBPT 

program, many commenters stated that 

a national GSPT program was not 

feasible and provided suggestions for 

implementing a CBPT program. 

HHS appealed the District Court’s 

ruling and sought to re-establish the 

cytology PT testing time frame 

established in the February 28, 1992 

final rule with comment. In a decision 

dated May 21, 1996, the United States 

Court of Appeals for the District of 

Columbia reversed and remanded those 

aspects of the District Court’s ruling. It 

provided that HHS could either offer an 

adequate explanation for the original 

cytology PT rule and reinstate that rule 

or issue a final rule in response to the 

comments received on the November 

30, 1995 proposed rule (60 FR 61509) 

(Consumer Federation of America and 

Public Citizen v. Department of Health 

and Human Services, 83 F.3d 1497, 

1506–07 (D.C. Cir. 1996)). 

On March 17, 2000, we published a 

notice in the Federal Register (65 FR 

14510) withdrawing the November 30, 

1995 proposed rule, providing further 

explanation of the rationale behind the 

1992 cytology PT provisions and 

reinstating the time frame for PT 

contained in the February 28, 1992 final 

rule with comment. The rationale 

provided further explanation for the 

original cytology PT rule provisions on 

test duration as required by the Court. 

It documented that the time provided 

for testing represented as reasonable an 

approximation of normal working 

conditions is possible under the 

circumstances. In the supplementary 

statement, HHS noted that the February 

28, 1992 final rule with comment 

stipulated time frame for cytology PT of 

5 slides per hour was based on the time 

frame used by the cytology PT program 

developed by the State of Maryland. 

CMS concluded that this time frame 

would provide for equitable testing on 

a national scale allowing individuals 

sufficient time to complete the test at 

their normal pace, without unduly 

restricting or extending the time for 

examination. This conclusion was 

reached even though a cytotechnologist 

who reviews the maximum number of 

slides per day would screen 

approximately 12.5 slides per hour. In 

the supplementary statement, HHS 

provided the following reasons for this 

conclusion: (1) A workload of 100 slides 

is the maximum allowed and not all 

cytology personnel examine 100 slides 

each day; (2) PT includes a higher ratio 

of abnormal to normal slides and should 

appropriately take longer to review; and 

(3) PT may include slides with different 

staining characteristics and test result 

forms that could be unfamiliar to the 

cytology personnel and require extra 

time for reporting results. HHS 

determined that the 2 hours to examine 

a 10 slide PT test set and 4 hours to 

examine a 20 slide PT retest used by the 

Maryland program were appropriate and 

took into account differences between 

examination of slides during normal 

workdays and during PT. 

D. Implementing Cytology PT 

1. Request for Proposal 

No PT programs requested CMS 

approval in time for the regulatory 

deadline of July 1st of each calendar 

year for nationwide cytology PT testing. 

In an effort to obtain the 26,000 

referenced Pap smears estimated to be 

needed to provide for a national 

cytology PT program, the CDC issued a 

Request for Proposal (RFP) in March 

1993, for a contractor to undertake 

procurement of the glass slides for use 

in administering the program. Although 

CDC did not receive any proposals in 

response to the RFP, they did receive 

comments from cytology organizations 

and individuals that echoed the 

comments previously received in 

response to the final regulations. The 

commenters stated that conducting a 

national GSPT program with on-site 

testing of individuals was logistically 

and financially infeasible, due to the 

expense associated with collecting the 

requisite number of high-quality glass 

slides representing appropriate 

diagnostic categories, and the time that 

would be needed to assemble, reference, 

and maintain the collection of slides. 

2. 1993 Symposium 

In November 1993, the CDC and CMS 

cosponsored a cytology symposium 

with the Cytology Education 

Consortium, (which at that time was 

composed of the American Society for 

Clinical Pathology (ASCP), the 

American Society of Cytology (ASC), the 

American Society for Cytotechnology 

(ASCT)), and the College of American 

Pathologists (CAP), to consider possible 

alternatives to a national cytology PT 

program using glass slides. A number of 

approaches were discussed, including 

state-administered glass slide programs, 

mailed glass slide programs, and 

programs that use photographic image 

representations (that is, color 

transparencies, color plates, or digitized 

computer images) of glass slide 

specimens instead of glass slides. It was 

determined that the most promising 

strategy would be to develop a variety 

of cytology PT programs to accomplish 

the mandate specified in Section 

353(f)(4)(B)(iv) of the PHS Act—‘‘* * * 

proficiency testing of such individuals, 

with such testing to take place, to the 

extent practicable, under normal 

working conditions, * * *.’’ 

3. Clinical Laboratory Improvement 

Advisory Committee (CLIAC) 

Recommendations 

The Secretary of HHS is authorized by 

the Public Health Service Act to 

establish advisory committees. The 

Clinical Laboratory Improvement 

Advisory Committee (CLIAC) was 

established on February 19, 1992 to 

provide scientific and technical advice 

to HHS. CLIAC membership consists of 

subject matter experts in laboratory 

medicine, pathology, public health, 

clinical practice, as well as a consumer 

representative and a liaison from private 

industry. Ex officio members represent 

the HHS agencies that administer the 

CLIA Program. On December 13, 1993, 

a CLIAC cytology subcommittee met to 

review alternative approaches to 

cytology PT. This meeting was 

suggested during the 1993 symposium 

to provide recommendations for 

consideration by CLIAC. The CLIAC met 

on December 14 through 15, 1993 to 

consider the recommendations of the 

cytology subcommittee. After 

deliberation, the committee endorsed 

those recommendations. The CLIAC 

recommended: (1) That research studies 

be conducted to define outcomes and 

evaluate the effectiveness of both glass 

slide and alternative cytology PT 

programs; (2) that regulatory revisions 

be promulgated, as needed, to permit 

approval of alternative programs; and 

(3) that statutory changes be pursued to 

allow cytology PT requirements, like PT 

requirements for other specialties and 

subspecialties, to be applied to the 

laboratory as a whole rather than to 

individuals. The CLIAC also encouraged 


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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, 

CytoViewTM

The recommendations from the 

cooperative agreement pilot evaluations 

were incorporated into the CBPT 

prototype developed by CDC, named 

CytoViewTM. 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.: CytoViewTM: A Prototype 

Computer Image-Based Papanicolaou 

Smear Proficiency Test, 43 Acta 

Cytologica 1045–1051 (1999). The first 

CytoViewTM 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 CytoViewTM 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 CytoViewTM 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 CytoViewTM 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. CytoViewTM II Development 

CytoViewTM II was developed in June 

1999 by the CDC based on comments 

received from the CytoViewTM

evaluation questionnaire. CytoViewTM 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 CytoViewTM II 

prototype was demonstrated at the 1999 

fall meetings of the ASCP/CAP and 

ASC. 

CDC trademarked the name 

CytoViewTM and in November 2000 a 

patent was issued on MicroScreen, the 

software used to capture the interactive 

images used by CytoViewTM. 

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 

CytoViewTM II prototype. To compare 

performance, a total of 111 individuals 

(52 pathologists and 59 

cytotechnologists) from participating instate laboratories were administered the 

two proficiency tests. The routine 

annual test of the MCPTP was 

administered to individuals following 

normal practice. CytoViewTM 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, CytoViewTM 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 (instate 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 


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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 CMSapproved 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 CLIAapproved 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 

§ 493.855(a) of the CLIA final rule with 

comment published February 28, 1992). 

The contention that laboratories 

should be tested rather than individuals 

is contrary to the plain language of the 

statute, and therefore was not 

considered in the development of the 

cytology PT program and was 

subsequently ruled out by CLIAC in 

considering possible refinements to the 

program. In addition, findings from 

individual testing in the State of 

Maryland indicated that certain 

individuals and certain subgroups (for 

example, pathologists working without 

cytotechnologists) had higher rates of 

test failure that would probably not be 

identified if cytology laboratories were 

scored as a whole rather than scoring 

each individual as required by the 

statute and current regulations. 

We stated our intention to review the 

entire program after a full year’s worth 

of national data were available and 

committed to working with the 

stakeholders and the CLIAC. We have 

fulfilled these commitments, giving rise 

to this proposed rule, as discussed in 

section II of the preamble. 

On November 9, 2005, in the 109th 

Congress, the Proficiency Testing 

Improvement Act of 2005 (H.R. 4268) 

was introduced in the House of 

Representatives. The legislation would 

have prohibited the Secretary of HHS 


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from conducting laboratory PT of 

individuals involved in screening or 

interpreting cytological preparations for 

1 year and required the Secretary to 

revise the PT requirements before 

resuming the program in order to (1) 

reflect the collaborative clinical 

decision-making of laboratory 

personnel; (2) revise grading or scoring 

criteria to reflect current practice 

guidelines; (3) provide for testing to be 

conducted no more often than every 2 

years; and (4) make other revisions as 

necessary to reflect changes in 

laboratory operations and practices 

since the original PT regulations were 

promulgated. This bill was referred to 

the House Committee on Energy and 

Commerce on November 9, 2005 and to 

the Subcommittee on Health on 

November 22, 2005. 

On December 16, 2005, a second 

Proficiency Testing Improvement Act of 

2005 (H.R. 4568) (identical to H.R. 4268) 

was introduced in the House of 

Representatives. This bill passed the 

House on December 17, 2005 and was 

referred to the Senate Committee on 

Health, Education, Labor, and Pensions 

on January 27, 2006. The Senate took no 

action on this bill. 

On September 21, 2006, the Cytology 

Proficiency Improvement Act of 2006 

(H.R. 6133) was introduced in the House 

of Representatives. This bill required 

the Secretary of HHS to revise national 

quality assurance standards to include 

requirements for each clinical laboratory 

to (1) ensure that all individuals 

involved in screening and interpreting 

cytological preparations participate 

annually in an approved continuing 

medical education program in 

gynecologic cytology that provides each 

participant with gynecologic cytologic 

preparations designed to improve 

locator, recognition, and interpretive 

skills; and (2) maintain a record of such 

program results. The Secretary was also 

required to terminate the existing 

individual cytology PT program. This 

bill was referred to the House 

Committee on Energy and Commerce on 

September 21, 2006 and to the 

Subcommittee on Health on October 2, 

2006. 

On November 15, 2006, an identical 

bill to H.R. 6133 was introduced in the 

Senate (S. 4056), and was referred to the 

Senate Committee on Health, Education, 

Labor, and Pensions. 

In December 2006 the 109th 

Congressional session came to an end 

with no action taken on H.R. 6133 or S. 

4056. 

In the 110th Congress, the Cytology 

Proficiency Improvement Act of 2007 

(H.R. 1237) was introduced in the House 

of Representatives on February 28, 2007, 

and was referred to the House 

Committee on Energy and Commerce on 

that date, and to the Subcommittee on 

Health on March 1, 2007. This bill was 

identical to H.R. 6133 from the 109th 

Congress. 

A Senate version of the Cytology 

Proficiency Improvement Act of 2007 

(S. 2510) was introduced on December 

18, 2007. While very similar to H.R. 

1237, this bill included some additional 

requirements for how the results of an 

individual’s participation in continuing 

medical education would be used. S. 

2510 was referred to the Senate 

Committee on Health, Education, Labor, 

and Pensions. 

H.R. 1237 was subsequently amended 

to be identical to S. 2510 and was 

passed by the House of Representatives 

on April 8, 2008. 

In December 2008 the 110th Congress 

ended with the Senate having taken no 

action on S. 2510. 

II. Rationale for Proposed Rule 

CLIA regulations for cytology PT were 

published in 1992 and implemented in 

Maryland in January 1995 following 

approval of the Maryland Cytology 

Proficiency Testing Program (MCPTP). 

The first program approved for 

nationwide cytology PT was the MIME 

program in 2005. 

To address the numerous concerns 

voiced about cytology PT 

implementation, the CMS presented a 

status report on cytology PT 

implementation during the CLIAC 

meeting in February 2005 and described 

the Cytology Personnel Records System 

(CYPERS). CYPERS was developed and 

implemented by us to maintain the 

confidentiality of an individual’s 

enrollment, participation, and PT 

scores, and to allow us to monitor 

individual performance in cytology PT. 

The notice for the new Privacy Act 

System of Records, CYPERS, was 

published in the Federal Register on 

January 14, 2005 (70 FR 2637). Also at 

the February 2005 CLIAC meeting, 

public comments opposing the 

implementation of cytology PT through 

the MIME program were presented by 

the ASC and ASCP, highlighting their 

concerns which included, (1) perceived 

problems with the scoring scheme and 

validation of slides; and (2) the 

regulations’ failure to consider the semiautomated 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 


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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

Correct response 

Examinee 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 CytoViewTM to test locator and interpretive skills. 

March 1997 ........................ CAP submitted an application for cytology PT program approval. 

June 1999 ........................... CDC developed CytoViewTM II. 


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CHRONOLOGY OF EVENTS—IMPLEMENTING CYTOLOGY PT—Continued 

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 

CytoViewTM 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, § 493.2 Definitions; Subpart 

H— Participation in Proficiency Testing 

for Laboratories Performing Nonwaived 

Testing, § 493.803 Condition: Successful 

participation; Subpart I— Proficiency 

Testing Programs for Nonwaived 

Testing, § 493.905 Nonapproved 

proficiency testing programs, and 

§ 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 § 493.853 

with the new Condition: Cytology: 

gynecologic specimen examinations at 

§ 493.853. We are proposing to remove 

and reserve § 493.855 Standard; 

Cytology: gynecologic examinations. 

The requirements currently at § 493.855 

will be moved to a new condition 

section (that is, § 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 


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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 

§ 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 § 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 noncytology 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-ofcare 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 


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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 

§ 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 welltrained 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 

§ 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 § 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 § 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 


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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 

§ 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 


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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 § 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 

§ 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 

§ 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 

§ 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 

§ 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 

§ 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 


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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 § 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 

§ 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 § 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 § 493.853(b)(3) to retain the 

90 percent or higher as the passing 

score. 


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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. 


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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 

Failure rate second test 

(1st retest) 2005 2006 * 

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 § 493.1449(b) or (k) to the 

following: 

Correct response 

Technical supervisor examinee 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 

§ 493.1469 or § 493.1483 to the 

following: 

Correct response 

Cytotechnologist examinee 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 


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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 

§ 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 

§ 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 § 493.855(c) with 

‘‘scores less than 90 percent’’ in 

proposed § 493.853(c). The 

requirements currently at 

§ 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 

§ 493.853(c)(2)(i) and § 493.853(c)(3)(i), 

respectively. We are proposing to 

maintain the requirements at § 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 

§ 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 

§ 493.853(c)(2)(i) and § 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 §§ 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 

§ 493.853(c)(2)(iii) and § 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 § 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 

§ 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 inhouse 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 

§ 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 § 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 × 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 × .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 × 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 reexamined. 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 × 20 days = 

1,500 slides to be rescreened per failed 

laboratory employee. 1,500 slides per 

failed laboratory employee × 110 failed 

employees = 165,000 slides to be 

rescreened. 165,000 slides to be 

rescreened × .21 hours per slides = 

34,650 hours OR 17,325 hours annually. 

Documentation Time: 165,000 slides to 

be rescreened × .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 × 35 

hours = 350 hours biennially OR 175 

hours annually) 

Cytology: gynecologic examinations 

§ 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 

§ 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 

§ 493.853(c). 

Section 493.945(b)(1)(i) states that if 

slides are still subject to retention by the 

laboratory, they may be loaned to a 

proficiency testing program if the 

program provides the laboratory with 

documentation of the loan of the slides 

and ensures that slides loaned to it are 

retrievable upon request. 

Sections 493.945(b)(4), (5), and (6) 

require the program to: 

• Provide a written description of the 

appeals process that is available to all 

individuals enrolled in the program. 

• Provide training for laboratory 

designated proctors that includes— 

(1) Written instructions for the 

laboratory to determine the number of 

proctors needed to administer the 

proficiency testing event, including 

contingency for a backup proctor if 

needed; 

(2) Written instructions for the 

laboratory director and proctor to ensure 

program procedures are fulfilled; and 

(3) A proctor examination that 

evaluates the proctor’s understanding of 

proper testing protocol. 

Provide a written agreement, to be 

signed by the laboratory director and 

returned to the program before testing, 

stating the laboratory is responsible for 

and accepts responsibility for 

administering the proficiency testing as 

defined by the program and CMS. 

Section 493.945(c)(1)(ii) requires the 

program to disclose their method of 

continuous field validation to 

participants before enrollment in the 

program. 

We have submitted a copy of this 

proposed rule to OMB for its review of 

the information collection requirements 

described above. These requirements are 

not effective until they have been 

approved by OMB. 

If you comment on these information 

collection and recordkeeping 

requirements, please do either of the 

following: 

1. Submit your comments 

electronically as specified in the 

ADDRESSES section of this proposed rule; 

or 

2. Mail copies to the address specified 

in the ADDRESSES section of this 

proposed rule and to the Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, 

Room 10235, New Executive Office 

Building, Washington, DC 20503, Attn: 

CMS Desk Officer, 

OIRA_submission@omb.eop.gov or fax 

(202) 395–6974. 

VI. Regulatory Impact Statement 

A. Overall Impact 

We have examined the impacts of this 

rule as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), Executive Order 13132 on 

Federalism, and the Congressional 

Review Act (5 U.S.C. 804(2)). 

Executive Order 12866 (as amended 

by Executive Order 13258, which 

merely reassigned responsibility of 

duties) directs agencies to assess all 

costs and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more in any 1 year). We 

do not believe this proposed rule would 

constitute an economically significant 

rule because it has no budget 

implications that would impact 

Medicare and Medicaid benefit 

payments by over $100 million in any 

one year. However, if finalized, the 

proposed rule would revise the 

requirements for cytology proficiency 

testing (PT) and would affect 

laboratories and individuals now 

subject to participation in PT, and could 

have some budget implications. In 

addition, this proposed rule, if finalized, 

would revise the requirements for 

cytology PT programs, which would 

cause the three existing PT programs to 

incur some costs as they modify their 

CMS-approved programs to meet the 

requirements specified in this rule. It 

may also have an effect on some States 

regarding State PT requirements. 

Therefore, we have prepared a RIA 

although the specified threshold to 

require a full analysis has not been met. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses, if a rule has a significant 

impact on a substantial number of small 

entities. For purposes of the RFA, 

almost all cytology laboratories are 

considered to be small entities. The 

cytology PT programs are also 

considered small entities due to their 

nonprofit status. Individuals and States 

are not included in the definition of a 

small entity. Based on our initial 

analysis, we expect that this proposed 

rule would not have a significant impact 

on a substantial number of small 


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Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 3283 

businesses or other small entities 

because only two of the proposed 

changes to the current PT requirements 

are anticipated to have non-negligible 

impacts, and these two changes are 

largely offsetting (that is, the increase in 

number of cytology challenges per test 

from 10 to 20, and decreased frequency 

of testing from annually to every other 

year). For the two year test cycle, there 

would be no increase in the amount of 

time an individual would spend taking 

the test. And although the number of 

challenges per test would increase, 

because the frequency of testing would 

decrease, programs would not need to 

increase the inventory of challenges to 

provide testing. Therefore, the Secretary 

has determined that this proposed rule 

would not have a significant economic 

impact on a substantial number of small 

entities. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 603 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a Metropolitan Statistical Area and has 

fewer than 100 beds. This proposed rule 

would not affect small rural hospitals 

because only two of the proposed 

changes to the current PT requirements 

are anticipated to have non-negligible 

impacts, and those two changes are 

largely offsetting (that is, the increase in 

number of cytology challenges per test 

from 10 to 20, and decreased frequency 

of testing from annually to every other 

year). Therefore, for purposes of our 

obligations under section 1102(b) of the 

SSA, we are not providing an analysis. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

also requires that agencies assess 

anticipated costs and benefits before 

issuing any rule whose mandates 

require spending in any 1 year of $100 

million in 1995 dollars, updated 

annually for inflation. That threshold 

level is currently approximately $130 

million. Based on our assessment, this 

rule would have no consequential effect 

on State, local, or tribal governments, or 

on the private sector. We anticipate that 

States will not incur substantial costs if 

this proposed rule is finalized because 

it does not contain changes that would 

result in significant cost differences 

from the regulations that are currently 

in place. We have determined that this 

proposed rule generally does not 

significantly affect States’ rights, roles, 

and responsibilities. This proposed rule 

would impact one State cytology PT 

program (Maryland), which currently 

meets the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) requirements for CMS approval, 

and would require the State to update 

their program requirements to meet the 

new final requirements. 

The objective of this regulatory 

impact analysis is to summarize the cost 

and benefits of implementing the 

regulations we are proposing. The 

conclusions and assumptions contained 

in this RIA are based on cytology PT 

data from 2005, the first year national 

testing took place. 

Public health benefits are not 

anticipated from the proposed changes 

to the cytology PT requirements 

compared to those in the existing 

regulation in terms of reducing the 

number of incorrect diagnoses or other 

public health measures (for example, 

reduction in false negative or false 

positive cervical cancer diagnoses, 

reduction in cervical cancer morbidity 

or mortality) based on analysis of 

relevant available data. As no data are 

available to suggest otherwise, we 

believe that the proposed changes may 

produce virtually the same results as the 

existing regulation in terms of PT 

outcomes (for example, examinee 

proficiency, number of examinees 

passing each test). We believe that the 

proposed regulations will result in a 

reduced burden on the population being 

tested and their employers. Some of this 

reduced burden is quantifiable in 

monetary terms as cost savings 

associated with less frequent testing; 

however, other effects can not be 

quantified. 

No distributional effects from the 

proposed changes are anticipated as 

they do not result in significant changes 

in treatments or outcomes for different 

groups. Further, the proposed changes 

are unlikely to increase market prices 

for Pap smears or other health care costs 

as they are not anticipated to result in 

any significant change in PT outcomes, 

or to increase the costs associated with 

gynecologic cytology PT. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This proposed rule will not have a 

substantial direct effect on State or local 

governments, preempt States, or 

otherwise have a Federalism 

implication. 

B. Anticipated Effects 

This proposed rule includes changes 

that, if finalized, would impact 2,142 

cytology laboratories and 12,831 

individuals (reference: http://www.cms.

hhs.gov/CLIA/downloads/2005Final

TestingResults080906MDMIME.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. 


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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 


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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¥Testing

Results¥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)) 


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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 offsite, 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. Travelrelated 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 testing/10 challenge first 

and second tests; 20 challenge 

third and fourth tests 

Proposed change 

testing every other year/all 20 

cytology challenge 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. 


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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 testing/10 challenge first 

and second tests; 20 challenge 

third and fourth tests 

Proposed change 

testing every other year/all 20 

cytology challenge 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. 


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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 testing/10 challenge first 

and second tests; 20 challenge 

third and fourth tests 

Proposed change 

testing every other year/all 20 

cytology challenge 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 

annual testing/10 challenge 

first and second tests 

Proposed change 

testing every other year/ 

all 20 cytology challenge 

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 testing/10 challenge first 

and second tests; 20 challenge 

third and fourth tests 

Proposed change 

testing every other year/all 20 

cytology challenge 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 


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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 § 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 

§ 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 


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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 (one miss 

on 10 challenges).

1st test: 20 cytology challenges ... one miss* = 90 percent—pass. 

two missed* = 80 percent (two 

misses on 20 cytology challenges). 

45 days—retest 

2nd test: 10 challenges ................. one miss* = 85 percent (equivalent to 2 misses* on 20 challenges).2nd test: 20 cytology challenges .. one miss* = 90 percent. 

two missed* = 80 percent (4 

misses* on 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 challenges ... two missed* = 80 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. 


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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 

§ 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 

§ 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 

§ 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 

§ 493.853(b)(4) and § 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 § 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 § 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 

§ 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 § 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 


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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: 

§ 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 § 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: 

§ 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 § 493.853(c) when 

scoring less than 90 percent on 

gynecologic cytology proficiency 

testing. 

* * * * * 

4. Section 493.853 is revised to read 

as follows: 

§ 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 

§ 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; 


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(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. 

§ 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: 

§ 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 § 493.901 through § 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: 

§ 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 

§ 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 

§ 493.1105(a)(7) and § 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. 


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(5) Provide training for laboratorydesignated 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 § 493.1449(b) or (k) are: 

Correct response 

Technical supervisor examinee 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 § 493.1469 or § 493.1483 

are: 

Correct response 

Cytotechnologist examinee 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 

§ 493.1451 [Amended] 

8. In § 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 


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