[Federal Register Volume 60, Number 230 (Thursday, November 30, 1995)]
[Proposed Rules]
[Pages 61508-61514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29190]



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[[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 

[[Page 61510]]
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.

[[Page 61511]]

    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 

[[Page 61512]]
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 

[[Page 61513]]
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