CLIA Program; Cytology Proficiency Testing

[[Page 61509]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

Centers for Disease Control and Prevention

42 CFR Part 493

[HSQ-233-P]

CLIA Program; Cytology Proficiency Testing

AGENCY: Health Care Financing Administration (HCFA) and Centers for

Disease Control and Prevention (CDC), HHS.

ACTION: Proposed rule.

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SUMMARY: In this proposal, HHS is complying with a court order

requiring publication of a proposed rule to require that cytology

proficiency testing (PT) be conducted, to the extent practicable, under

normal working conditions. In accordance with the court order, we are

proposing to revise regulations that implement the Clinical Laboratory

Improvement Amendments of 1988 (CLIA) to require that PT be conducted

at a pace corresponding to the maximum workload rate for individuals

examining cytology slides. As a separate matter, we use this

opportunity to solicit comments on the use of computer facsimile

representations of cytology specimens, as an alternative to glass slide

PT.

DATES: Comments will be considered if we receive them at the

appropriate address, as provided below, no later than 5 p.m. on January

29, 1996.

ADDRESSES: Mail written comments (1 original and 3 copies) to the

following address: Centers for Disease Control and Prevention,

Attention: HSQ-233-P, 4770 Buford Hwy, N.E., MS F11, Atlanta, Ga.

30341-3724.

If you prefer, you may deliver your written comments (1 original

and 3 copies) to the following address: Room 309-G, Hubert H. Humphrey

Building, 200 Independence Avenue, SW., Washington, DC 20201.

Because of staffing and resource limitations, we cannot accept

comments by facsimile (FAX) transmission. In commenting, please refer

to file code HSQ-233-P. Comments received timely will be available for

public inspection as they are received in Room 309-G of the

Department's offices at 200 Independence Avenue, SW., Washington, DC,

on Monday through Friday of each week from 8:30 a.m. to 5 p.m. (phone:

(202) 690-7890).

For comments that relate to information collection requirements,

mail a copy of comments to: Office of Information and Regulatory

Affairs, Office of Management and Budget, Room 10235, New Executive

Office Building, Washington, DC 20503, Attn: Allison Herron Eydt, HCFA

Desk Officer.

FOR FURTHER INFORMATION CONTACT: Rhonda S. Whalen, (770) 488-7670.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 353 of the Public Health Service Act (42 U.S.C.

263a), which embodies provisions of the Clinical Laboratory Improvement

Amendments of 1988 (CLIA), all laboratories that examine human

specimens for the diagnosis, prevention or treatment of any disease or

impairment of, or the assessment of the health of, human beings must

meet certain requirements to perform the examination. On February 28,

1992 (57 FR 7002), we published regulations to implement CLIA at 42 CFR

part 493, with most sections of the regulations effective September 1,

1992. On January 14, 1993, plaintiffs, the Consumer Federation of

America and Public Citizen, filed a lawsuit in the United States

District Court for the District of Columbia, challenging the Department

of Health and Human Services' implementation of CLIA (Consumer

Federation of America and Public Citizen v. HHS, Civil Action No. 93-97

(D.D.C.)). As one aspect of their complaint, plaintiffs argued that the

regulations violated the requirements of the law by failing to require

cytology proficiency testing (PT) ``to the extent practicable, under

normal working conditions.''

On August 29, 1995, the court ruled that the regulations did not

strictly conform to the statute. The court ruled that, within 90 days

of this order, we publish proposed regulations in the Federal Register,

in accordance with 42 U.S.C. 263a(f)(4)(B)(iv) regarding proficiency

testing of cytologists, to ensure that cytologists are tested, to the

extent practicable, under normal working conditions, and request public

comment. The court further ruled that we are to issue a final rule

regarding the same within a reasonable time thereafter. As provided in

the court's August 29 ruling, the PT regulations promulgated by the

Department on February 28, 1992, remain in effect pending the issuance

of the final PT regulations required by the court. It should be noted

that this particular notice only addresses matters in the court order

pertaining to cytology PT, and it is not designed to respond to a

separate part of the court order pertaining to test classification and

personnel standards.

II. Proposed Rule

In this proposed rule, we are complying with that portion of the

court order requiring the publication of proposed regulations and

solicitation of public comment to ensure that PT of cytology personnel

is conducted, to the extent practicable, under normal working

conditions. We note, however, that the Department of HHS has filed a

notice of appeal with respect to the order. If the order is reversed on

appeal, we would still review the comments and carefully consider the

appropriate course of action.

The current PT regulations are based on the principle that

effective and appropriate PT should not be equated to the routine

examination of patient specimens. Nevertheless, in accordance with the

court's ruling, we are soliciting comments on a proposal to change the

current regulations (which authorize the examination of PT slides at a

rate of five slides per hour), to require the examination of PT slides

at a new rate, which is set at the maximum workload rate of 12.5 slides

per hour. To achieve this PT workload rate, in this rule, we are

proposing to change the amount of time allowed for completion of the PT

examination from 2 hours to 45 minutes, while retaining the same number

of slides (10) per test. (For a 20-slide PT retest, the test time would

change from 4 hours to 90 minutes.)

We recognize that there may be other options for complying with the

court order requiring that PT be conducted under normal working

conditions. One option for consideration to comply with the order would

be to maintain the current 2-hour testing time period but increase the

number of slides per PT examination (in other words, require the

examination of 25 slides in a 2-hour period and, for a retest, require

50 slides to be examined in a 4-hour period). We are cautious about

supporting this alternative because we have concerns about the

practical feasibility of obtaining sufficient referenced slides for a

nationally-administered 25-slide test set for PT; however, we are

interested in receiving comments on this option. Another option would

be to specify that PT be conducted at each individual's actual workload

rate (which could be less than the maximum workload rate) for examining

patient slides. We recognize that this alternative will present

problems in administering PT but are interested in receiving comments

on the appropriateness of such a proposal, together with

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suggestions for specific regulatory language that could implement such

a provision in a fair and consistent manner.

We also are interested in receiving comment on several

alternatives.

We are interested in receiving comment on the

establishment of an average workload rate (perhaps within an interval)

that would be based upon available empirical data on cytotechnologist

productivity and would accurately reflect normal working conditions.

We solicit comments on varying the ratio of abnormal PT

slides so the failure rate would better reflect such a rate under

``normal working conditions.''

We solicit comment on establishing differing definitions

of ``normal working conditions,'' dependent on the ratio of abnormal PT

slides.

We solicit further comment on the feasibility of blind

testing in cytology PT.

We solicit comment on the feasibility and desirability of

mandating unannounced PT, both on-site and off-premises.

Finally, we solicit comment on the appropriateness of

defining ``normal working conditions'' as maximum workloads for non-PT

slides, as defined in Sec. 493.1257(b).

A. Rationale for the PT Timeframe in Current Regulations

In the regulations published February 28, 1992, we established the

time limits for cytology PT to provide for equitable testing on a

national scale and to allow individuals sufficient time to complete the

test at a normal pace without unduly restricting or extending the time

for the examination. (57 FR 7041) This maximum time frame established

for the administration of PT was not intended to hold individuals to a

workload limit related to their examination of patient material because

we believe that this would be an unreasonable standard, since there are

salient differences between the routine examination of patient material

and cytology PT.

We note several reasons why cytology PT is not identical to the

routine evaluation of patient material, both in terms of the

microscopic examination and the reporting of results. To assess the

proficiency of personnel, slides used for cytology PT include a high

percentage of abnormal preparations which could be up to 80 percent of

the challenges for the testing event, whereas a laboratory's routine

patient case load might vary, with abnormal cases representing 5

percent to 25 percent of the total volume. In our judgment, compared to

normal cases, examination of abnormal cases may take significantly

longer to analyze and determine conclusively whether the cells are

benign or malignant and to specify the type of abnormality and

recommendations for treatment or follow up. A complex scale for

categorizing and grading such abnormal PT results is defined in the

current regulation in abundant detail in the tables at 42 CFR 493.945.

The 12.5 slides per hour maximum workload rate is based upon a normal,

``real world'' distribution of 5 percent abnormal slides per day. On

the other hand, the PT rate of 5 slides per hour is based upon an

intentionally constructed testing mixture of up to 80 percent abnormal

slides in the PT test set.

The current PT regulation is based on the principle that, in the

limited time available to conduct cytology PT, it is appropriate to

test cytology personnel using a high rate of abnormal slides. The

reason for this is that there are many types of diagnostic

abnormalities and it is important to evaluate the examinee's ability to

correctly identify the abnormal conditions. In our view, it is

inefficient to test these individuals using the natural distribution

rate of 5 percent abnormals because it would take many more PT

examinations to develop any reliable information about an individual's

proficiency over the spectrum of possible abnormal specimens. In

addition, although all slides will be evaluated and assessed for

appropriateness for inclusion in test sets, in some instances examinees

may note that staining used for PT slides varies in intensity from that

used in their laboratories for the evaluation of patient specimens.

Since there is no uniform or standard format used by laboratories to

report Pap smear results, for scoring purposes, PT report forms and

nomenclature may be different from the examinee's usual workplace

experience. Individuals, who are perfectly capable of examining patient

slides, may need additional time to adjust to the testing model, which

may include unavoidable differences from routine working conditions.

Every effort should be made to ensure that individuals are fairly

assessed in their ability to examine patient specimens and are not

unfairly penalized for failure to perform satisfactorily in PT if they

have no real problems examining patient material. We solicit comments

as to whether or not these factors should be appropriately used to

extend the amount of time allowed for a PT examination.

In the current CLIA regulations, we established the testing

procedure using an above average ratio of abnormal slides, but a

correspondingly longer period to review each slide, as an appropriate

implementation of the obligation to test ``...to the extent

practicable, under normal working conditions.'' In this context, it

should be noted that we indicated in the February 28, 1992 regulations,

at Sec. 493.1257(b), the workload limit represents the maximum number,

a total of 100 slides, that may be screened in a 24-hour period and

``is not to be employed as a performance target for each individual,''

[emphasis added].

Due to practical realities, we believe that cytology PT can not be

conducted in a ``blind'' fashion. We believe that PT challenges cannot

be inserted into the laboratory's routine workload because such slides

would be immediately identifiable, and no oversight would be provided

to ensure that consultation does not occur among individuals being

tested. We invite comments on these limitations to blind PT and our

view that individual PT needs to provide a reasonable time for these

extraneous testing factors.

In summary, in the February 28, 1992 regulations, we determined

that a 2-hour time period would be reasonable for the examination of a

10-slide test set, and the 2-hour time frame is supported by the State

of Maryland's experience in administering cytology PT for over 6 years

using this time frame. (In 1994, the Maryland program received approval

under CLIA, and has a current enrollment of 80 laboratories.)

Consistent with the court's order discussed above, we hereby

solicit comments on the proposal to change the rate for examination of

PT slides to approximately 12.5 slides per hour, which equates to 45

minutes for a 10-slide test set and 90 minutes for a 20-slide test set.

We also seek comments on the two options mentioned above. We also

solicit comments on any other suggested procedures for complying with

the court's order that PT be conducted under normal working conditions.

B. Current Status of Cytology PT Implementation

Prior to 1992, we anticipated that private, not-for-profit

organizations and States would develop and administer cytology

programs, as is the case for all other PT. However, following

publication of the February 28, 1992 regulations, we received no

applications for approval of a cytology PT program, but we did receive

a number of comments expressing concerns about the feasibility of

conducting a national cytology PT program to test individuals.

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In June 1992, the Centers for Disease Control and Prevention hosted

a meeting of the cytology professional organizations and States having

cytology PT programs to solicit support in the development and

implementation of a national cytology PT program. Participants at this

meeting had reservations about the feasibility of conducting a national

glass slide PT program that included on-site testing of individuals.

In March 1993, the Centers for Disease Control and Prevention

issued a Request for Proposal for a contractor to undertake procurement

of the glass slides for use in administering a national cytology PT

program. No responses were received to the Request for Proposal.

However, we did receive additional comments from cytology societies and

individuals that echoed the comments previously received in response to

the February 28, 1992 regulations. The commenters stated that

conducting a national glass slide PT program with on-site testing of

individuals was logistically and financially unworkable, due to the

high cost of collecting the requisite number of glass slides

representing appropriate diagnostic categories, and the time that would

be needed to assemble and reference such a collection of slides.

Several commenters also noted that, although a national program may be

impossible to implement, implementing a cytology PT program by region

or State might be feasible.

In November 1993, the Centers for Disease Control and Prevention

cosponsored a cytology symposium to consider possible alternatives to a

national cytology PT program using glass slides, and a number of

potential approaches were discussed. The participants believed that the

most promising strategy would be to develop a variety of cytology PT

programs to accomplish the statutory mandate of testing the proficiency

of cytology personnel. Alternative approaches suggested included State-

administered glass slide programs, mailed glass slide programs, or

national programs that use photographic facsimile representations (in

other words, color transparencies, color plates, digitized computer

images) of cytology preparations in lieu of glass slides.

In December 1993, the subcommittee on cytology of the Clinical

Laboratory Improvement Advisory Committee met to review the proceedings

from the symposium, and to make recommendations concerning cytology PT.

Following the subcommittee meeting, the full Clinical Laboratory

Improvement Advisory Committee met and endorsed the recommendations

made by the subcommittee. The Clinical Laboratory Improvement Advisory

Committee recommended that research studies be conducted to define

outcomes and evaluate the effectiveness of both glass slide and

alternative cytology PT programs and that regulatory changes be pursued

to permit approval of alternative programs. The committee also

encouraged professional organizations and States to develop programs to

meet the current regulations and become operational.

Currently, cytology PT is not being conducted nationally. To date,

two State-operated cytology PT programs have applied for approval under

CLIA. The State of Wisconsin subsequently withdrew its application when

it was unable to obtain a sufficient number of referenced glass slides.

The other applicant, the State of Maryland Cytology Proficiency Testing

Program, met the CLIA cytology PT requirements and was granted approval

for calendar year 1995. To date, we have received no other

applications.

C. Alternatives to Glass Slide Testing

The major impediment in making cytology PT available on a national

basis has been and continues to be the difficulty in obtaining a

sufficient number of properly referenced glass slides. We believe that

programs using facsimiles of glass slides (in other words, computer

images) may provide the most reasonable alternative to evaluating

cytology performance using traditional glass slide programs.

Computer-based programs offer the advantage of providing for the

accumulation and assembly of sufficient numbers of well-documented,

referenced cytology preparations that can be used for testing

individuals in a consistent and uniform manner. We believe that

revising the requirements to allow the use of testing media other than

glass slides is the most promising approach to making cytology PT

available nationwide and would reflect the intent of the Congress in

enacting the CLIA legislation. In the Report of the House Energy and

Commerce Committee that accompanies the Clinical Laboratory Improvement

Amendments of 1988, Public Law 100-578, H.R. Rept. No. 100-899, 100th

Congress, 2nd Sess., pp. 29-31, HHS was 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 on-site proficiency testing.'' In addition, the Committee

Report stated that the Committee expected HHS ``. . . to foster

innovative approaches, including video technology, for developing

proficiency testing for analytes for which such testing is not

currently available.''

To promote the development of alternative PT programs in cytology,

the Centers for Disease Control and Prevention awarded three 1-year

cooperative agreements in 1994. These agreements included provisions

for the development of computer-based PT programs to measure cytology

performance, and provisions for the evaluation of such programs through

pilot studies. Early in 1995, the Centers for Disease Control and

Prevention awarded a 2-year contract to compare the actual work

performance of cytology personnel with their performance in both a

glass slide PT program and a computer-based PT program, which simulates

the screening process and includes the evaluation of locator and

interpretive skills.

D. Request for Comments on Computer-Based Cytology PT Programs

We are soliciting comments on expanding the CLIA regulations to

permit the use of computer facsimile representations of cytology

specimens as an alternative to glass slide PT examinations. We are

particularly interested in receiving comments from individuals and

organizations with experience in computer systems for microscopic

examination of cytology preparations (glass slides) and the ability of

this technology to closely simulate normal working conditions.

We are specifically soliciting comments which respond to the

following questions:

1. Should computer-based cytology PT programs measure both

interpretive and locator skills? Interpretive skills are those required

to look at a particular cell or set of cells and determine a diagnostic

condition; locator skills are those required to scan a slide and select

a cell or group of cells for interpretation. As technology is now

available to measure interpretive skills but development is needed to

expand capabilities to include locator skills, should we consider a

phase-in period during which PT programs would be required only to

evaluate interpretive skills?

2. How can computer-based PT programs meet the provisions in the

law requiring unannounced testing and that testing take place, to the

extent practicable, under normal working conditions? At the current

level of technology, computer testing events to evaluate interpretive

and locator skills would probably need to be announced

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and occur at testing centers, rather than in the laboratory.

3. Should the number of slides or challenges in the current

regulations be changed for computer technology? Since this technology

is not limited by ability to collect referenced glass slides, it is

possible to provide more challenges (images or portions of slides) to

evaluate proficiency.

4. Should the scoring system be modified for computer-based

programs?

Finally, we recognize that this technology is relatively new and,

while it affords many advantages, we are most interested in obtaining

comments about the acceptance of computer-based programs for evaluating

cytology skills.

Following receipt and analysis of the comments, we plan to consider

these suggestions and comments and, if warranted, develop a proposed

rule to expand the regulations to allow approval of cytology PT

programs that include computer-based testing media as an alternative to

glass slides. In any such proposed rule on computer-based testing, we

would provide specific revisions to the regulations. We would respond

to comments on the proposed rule when we finalize any changes to our

existing rules.

III. Proposed Revision to the Regulations

This proposed rule is in response to the court's decision that the

12.5 slide per hour rate contained in Sec. 493.1257(b), must, in the

court's opinion, also be the rate for cytology PT, which is delineated

at Sec. 493.855(b). Accordingly, the Department complies with the court

decision and proposes and solicits comments on revisions to

Sec. 493.855(b) to change the time frame in which individuals must

complete: a 10-slide test, from not more than 2 hours to 45 minutes;

and a 20-slide test, from not more than 4 hours to 90 minutes.

IV. Response to Comments

Because of the large number of items or correspondence we normally

receive on Federal Register documents published for comment, 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 final

rule, we will respond to the comments in the preamble to that document.

V. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995, agencies 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 Paperwork Reduction Act

of 1995 requires that we solicit comment on the following issues:

Whether the information collection is necessary and useful

to carry out the proper functions of the agency;

The accuracy of the agency's estimate of the information

collection burden;

The quality, utility, and clarity of the information to be

collected; and

Recommendations to minimize the information collection

burden of the affected public, including automated collection

techniques.

Section 493.855 contains the requirement that laboratories ensure

that each individual engaged in the cytological examination of

gynecologic specimens participate in an annual testing event. We

estimate that 15,000 individuals would be subject to testing. Once each

year they must complete required reporting forms, estimated to take 10

minutes per response. The total burden associated with this requirement

is estimated to be 2,500 hours.

Section 493.855 is currently approved under OMB approval number

0938-0612, with an expiration date of February 28, 1998.

Comments should be sent to HCFA, OFHR, MPAS, C2-26-17, 7500

Security Boulevard, Baltimore, Maryland 21244-1850 and to the OMB

official whose name appears in the ADDRESSES section of this proposed

rule.

VI. Regulatory Impact Statement

Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601

through 612), we prepare a regulatory flexibility analysis unless we

certify that a rule would not have a significant economic impact on a

substantial number of small entities. For purposes of the RFA, all

clinical laboratories are considered to be small entities. Individuals

and States are not included in the definition of a small entity.

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. Such

an 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 50 beds.

This proposed rule would modify the CLIA regulations published

February 28, 1992 by changing the current requirements authorizing the

examination of PT slides at a rate of five slides per hour, to require

the examination of PT slides at the maximum workload rate of 12.5

slides per hour (for examination of patient preparations). This

proposed revision is in accordance with the court order requiring us to

publish a notice of proposed rulemaking that would require PT to be

conducted within the time frame corresponding to the maximum workload

rate for individuals examining cytology slides. There are approximately

16,600 cytotechnologists and pathologists and one HCFA-approved

cytology PT program that could be affected by this rule; however, the

significance of the effect would vary depending on the number of

individuals having to take a second or third retest and whether or not

the one cytology PT program in Maryland approved by HHS under current

regulations would seek approval, if the proposed revised criteria for

cytology PT are finalized.

The final rule published February 28, 1992 (57 FR 7002) and

subsequently revised December 6, 1994 (59 FR 62606) provided a phase-in

period for enrollment in a HCFA-approved cytology PT program.

Specifically, as of January 1, 1995, individuals must enroll in an

approved program, if one is available in the State in which he or she

is employed (currently only Maryland). Under the CLIA cytology PT

requirements, each person examining cytologic preparations is tested on

his or her ability to categorize each slide into one of four response

categories. After an initial PT failure, the examinee must take a

second 10-slide test within 45 days. In the event of a second failure,

the laboratory must provide immediate remedial training to any

individual who fails the second test or retest.

The second failure also triggers a mandatory rescreen of all

subsequent slides by another cytologist until the individual is

retested. Failure of the third test, consisting of 20 slides, results

in immediate suspension of an individual's screening privileges. The

individual must complete remedial training of at least 35 hours before

he or she can be retested. Successful completion of a 20-slide test is

required before screening of gynecological slides may resume.

As mentioned earlier in this preamble, other factors (for example,

variations in staining intensity and nonroutine nomenclature on report

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forms) may add to the anxiety level associated with PT participation

and adversely affect PT performance. Decreasing the time frame in which

individuals must complete the PT examination may increase the overall

costs of cytology PT due to an increase in the failure rate of

individuals who would be forced to examine PT slides at a rate greater

than their normal workload rate (for individuals who examine slides at

a workload rate that is less than the maximum). In the case of

pathologists, who do not routinely screen slides and therefore are not

subject to a workload limit, a higher failure rate might also be

expected.

Costs associated with taking the second test and rescreening slides

for the 20 work days between tests would increase in proportion to the

increased failure rate. In addition, if a greater number of individuals

must take the third retest off-site, we assume one day of work per

examinee would be lost.

The costs of this proposed rule would be confined to the difference

in lost wages because of an expected increase in rates of failure for

both cytotechnologists and cytopathologists and an increase in costs

needed because of rescreening more slides and retraining an increased

number of examinees.

Estimated Costs

The data we are using in this proposed rule are the data we used to

determine the impact of the February 1992 rule. The regulatory impact

analysis in that rule projected national costs from data pertaining to

1990 that we received from the Maryland State Cytology Testing Program.

We have no more recent data from which to project national figures at

this time, and there is no other HCFA-approved testing program to

validate or invalidate the Maryland State experience.

The base population that we are using for this impact analysis

consists of 7,950 cytotechnologists and 8,690 pathologists. We are

assuming a range of wages for cytotechnologists of $14 to $20 per hour

and for pathologists a range of $75 to $110 per hour. We are assuming

that conducting an on-site test that lasts 45 minutes will consume 2

hours per examinee, instead of the 5 hours we currently allot for each

examinee to take a 2-hour test.

Based on these assumptions, we project the following: The first

round of tests will cost from $2.0 to $2.9 million. This represents

savings of $3.0 to $4.3 million from our estimate of what it would cost

to test under current requirements.

In order to measure the possible costs of retesting, we estimated

that under the new time constraints 25 percent of the examinees would

fail the first test. We project that costs associated with taking the

second test, assumed to be conducted off-site, will be $3.1 to $4.5

million.

We estimate that 25 percent of the persons taking the second test

will fail that examination and that it would cost $1.7 to $2.4 million

for the rescreening required and from $0.4 to $0.7 million in time lost

to conduct the third test. Again, we assume one day of work per

examinee will be lost due to off-site testing. If an on-site testing

option is offered and selected, costs may be significantly lower.

We estimate that 25 percent of those failing the second test would

fail the third test (260 persons) and that it would cost from $0.6 to

$0.8 million in lost time to retrain cytotechnologists and from $3.3 to

$6.5 million to retrain pathologists. The costs of retraining include

the cost of 40 days of time lost; this includes 5 days for training and

35 days waiting for the next examination to be given, assuming the

examinations are not offered more than once a month. We have no data or

information on which to base an estimate of the cost of the training

itself.

The total costs attributable to the proposed PT requirements would

range from $10.9 to $17.8 million in the first year of testing in a

nationwide cytology PT program. This represents an increase of $0.5 to

$1.6 million over our original projected costs of $10.4 to $16.1

million (excluding the cytology slide test costs which would remain

unchanged in this proposed rule) for our current PT requirements. This

difference reflects the impact of the assumed increase in the test

failure rate on the associated costs of retesting and retraining an

increased number of examinees and rescreening more slides. It is

possible that costs would go down somewhat in subsequent years: the

Maryland State Cytology Testing Program showed a decrease in the

percentage of examinees failing the testing after the first year.

Projected Annual Costs of Cytology Proficiency Testing

------------------------------------------------------------------------

Low High

------------------------------------------------------------------------

Conduct of first testing........................ $2,025,000 $2,895,000

Conduct of second testing....................... 3,058,000 4,467,000

Cost to rescreen for 20 workdays................ 1,667,000 2,383,000

Conduct of third testing........................ 384,000 733,000

Loss of 40 days Cytotechnologist................ 561,000 802,000

Loss of 40 days Cytopathologist................. 3,246,000 6,493,000

-----------------------

Costs through hired testing................. 10,941,000 17,773,000

------------------------------------------------------------------------

The effect of the proposed change on the only HCFA-approved

cytology PT program, Maryland State Cytology Testing Program, is

difficult to predict, until we are notified whether the program intends

to make revisions to its requirements for examination of PT slides

complying with these proposed revisions (if finalized). However, if

Maryland maintains an approved program, we predict that it would have

comparable increases in costs after the first test because of the

greater number of persons failing.

If Maryland chooses not to make the revisions, the program would

fail to meet the criteria for CLIA-approval as a cytology PT program.

HCFA would notify the program of the nonapproval, and the program would

then have to notify all laboratories enrolled in the program of the

nonapproval and the reasons for nonapproval within 30 days of the HCFA

notification. If this occurs, until other State programs are approved

or a nationwide cytology PT program is available, none of the

cytotechnologists and pathologists in this country who examine

gynecologic cytology preparations would be participating in an approved

cytology PT program.

We are not preparing an analysis for either the RFA or section

1102(b) of the Act because we have determined, and the Secretary

certifies, that this proposed 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.

Also, we considered the economic aspects of whether or not the

proposed change would reduce or increase health care costs by leading

to the correct earlier diagnosis of pap smears that would otherwise be

misread as false positive or false negative under the existing

regulations. Because the potential economic effects of this proposal

are so speculative pertaining to any impact on health care costs, we

are unable to factor such costs into this analysis. Similarly, we

considered the economic impact on individuals due to

[[Page 61514]]

loss of employment, but again, we are unable to factor such costs into

this analysis because the economic effects are so speculative.

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

Grant programs--health, Health facilities, Laboratories, Medicaid,

Medicare, Reporting and recordkeeping requirements.

42 CFR part 493 would be amended as set forth below:

PART 493--LABORATORY REQUIREMENTS

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

follows:

Authority: Sec. 353 of the Public Health Service Act, secs.

1102, 1861(e), the sentence following 1861(s)(11), 1861(s)(12),

1861(s)(13), 1861(s)(14), 1861(s)(15), and 1861(s)(16) of the Social

Security Act (42 U.S.C. 263a, 1302, 1395x(e), the sentence following

1395x(s)(11), 1395x(s)(12), 1395x(s)(13), 1395x(s)(14),

1395x(s)(15), and 1395x(s)(16)).

2. Section 493.855, paragraph (b) introductory text is revised to

read as follows:

Sec. 493.855 Standard; Cytology: gynecologic examinations.

* * * * *

(b) The laboratory must ensure that each individual participates in

an annual testing event that involves the examination of a 10-slide

test set as described in Sec. 493.945. Individuals who fail this

testing event are retested with another 10-slide test set as described

in paragraphs (b)(1) and (b)(2) of this section. Individuals who fail

this second test are subsequently retested with a 20-slide test set as

described in paragraphs (b)(2) and (b)(3) of this section. Individuals

are given not more than 45 minutes to complete a 10-slide test and not

more than 90 minutes to complete a 20-slide test. Unexcused failure to

appear by an individual for a retest will result in test failure with

resulting remediation and limitations on slide examination as specified

in (b)(1), (b)(2), and (b)(3) of this section.

* * * * *

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical

Assistance Program; Program No. 93.773, Medicare--Hospital

Insurance; and Program No. 93.774, Medicare--Supplementary Medical

Insurance Program)

Dated: November 21, 1995.

Helen Smits,

Deputy Administrator, Health Care Financing Administration.

Dated: November 21, 1995.

Frances Lee de Peyster,

Director, Centers for Disease Control and Prevention, Washington

Office.

Dated: November 21, 1995.

Donna E. Shalala,

Secretary.

[FR Doc. 95-29190 Filed 11-27-95; 11:59 am]

BILLING CODE 4120-01-P