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Requested Comments by CMS

Cytology Challenges and new Technology

1)Is the proposed definition for‘‘cytology challenge’’ appropriate toaddress future technological advances?

The words “cytology challenge” are sufficiently nonrestrictive and should be used to include future technological advances for screening and interpreting gynecologic cytology.

2)Should criteria be included in theregulations for pilot testing before CMSapproval of any new cytology testingmedia? If so, please specify theappropriate criteria.

No. There should be no criteria for pilot testing required in the regulations. It would be impossible to describe and design criteria for reasonable and timely pilot studies for unknown technologies. Providers should design and execute pilot studies with rigorous statistical analysis based upon the methods of testing employed.

3)Should pilot testing include acomparison to current technology? Whatis an acceptable comparison?

No specific criteria for pilot testing should be stipulated in the regulations. However, Providers should outline their specific methods usedfor pilot testing, including inter-method comparison. Comparisons should require rigorous statistical validation.

4)If specific criteria for pilot testingare required, what burden would beincurred by PT programs andlaboratories participating in a pilot test?

No pilot testing should be stipulated in the regulations. However, all pilot testing performed by providers should require statistical validations. Costs of pilot testing to providers and laboratories are burdensome. The providers must incur the costs of setting up a pilot study. Laboratories participating in the pilot study incur the time costs of providing pathologists (i.e. technical supervisors), cytotechnologists and proctors for two tests (i.e. standard glass slide examination and the new technology examination).

5)Would requiring pilot testing causean increase in the cost of cytology PT?

Pilot testing should not be stipulated in the regulations. However, pilot testing would cause an increase in the cost and the additional cost would be passed on to participants.

B. Testing Individuals

1)Should enrollment andparticipation in an educational programbe required for all cytology laboratories? If so, how would this enrollment bemonitored by CMS?

No. Enrollment and participation in educational programs are best managed and conducted by professional organizations, state licensing boards, and hospital and laboratory accreditation programs such as College of American Pathologists (CAP) Laboratory Accreditation Program, or even the Joint Commission. These organizations already exist and determine appropriate criteria, format and valid content for educational programs and are approved by medical education accrediting agencies such as the Accreditation Councilfor Continuing Medical Education(ACCME) or the AmericanAcademy of Continuing Medical Education (AAOCME) for physicians. In addition, the American Society of Cytopathology (ASC) provides educational programs accredited by the (ACCMEE) for physician members as well as Continuing Medical Laboratory Education (CMLE) for cytotechnologists that meet the continuing education requirements for the ASCP Board of Registry Certification Maintenance Program.

REFERENCE:

Birdsong G, Howell L and Atkison K et al. Scientific issues related to the cytology proficiency testing regulations. Cytojournal 2006 April 18;3:11

2)If enrollment and participation ineducational programs were to berequired, what criteria would beappropriate for CMS to adopt throughrulemaking to evaluate these programs?

CMS should not mandate participation in an educational program such as proficiency testing. If CMS adopted a rule for mandatory education, the criteria for educational materials should not be determined by CMS. The criteria for these educational materials or programs should be under the purview of accrediting educational organizations with well established histories in the field of education and teaching.

3)If enrollment and participation ineducational programs were to berequired, how might CMS monitor orevaluate an individual’s participation insuch a program?

If CMS adopted a rule for mandatory education instead of gynecologic proficiency testing, the process should be monitored by its deemed laboratory accrediting organizations. CMS does not have the resources, to monitor or evaluate an individual’s participation in educational programs.

4)If educational programs wererequired, what enforcement actionsmight be appropriate for laboratories iflaboratories/individuals did notparticipate in the required programs?

Accreditation agencies should monitor education in laboratories and provide enforcement for lack of participation. Laboratories should provide the opportunity for education for individuals . Laboratories that do not maintain compliance would be managed according to their deemed laboratory accrediting organization protocol.

C. Frequency of Testing

1)How many cytology challenges pertest event are appropriate to assessindividual performance?

Individual performance does not indicate proficiency; proficiency is a multifactoral process of which one portion consists of the screening and interpretation tasks embodied in the current PT event. Other considerations involved in proficiency may include such items as judgment as to when to obtain additional history and consultation with other care providers and cytologists, and when to consult with reference material (items precluded in the current testing protocol). No one test can assess individual performance in an environment of evolving technology and future molecular testing. The law states “periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytologic preparations, including announced and unannounced on-site testing of individuals, with testing to take place, to the extent practicable, under normal working conditions.” PT testing, as currently configured, does not provide a “normal working conditions” environment.

Statistical theory would dictate that the higher the number of challenges per test event, the better a program can assess individual performance; however, there are practical limitations to large challenge sets. When choosing the optimal challenges, it is accepted practice to understand the misclassification rates utilizing binomial expansion theory and applying test criteria with examples rates of both “competent” and “incompetent” individuals. For example, the misclassification or false pass rate for incompetent individuals (true pass rate at 80%) against a 90% pass rule drops from 38% with a 10 slide (challenge) set to 20% with a 20 slide set. Additionally, the misclassification or false failure rate for competent individuals (true pass rate at 95%) only drops from 9% with a 10 slide set to 8% with a 20 slide test. Therefore, based upon the change in false positive rates, there may be a rationale to move from a 10 slide testing event to a 20 slide testing event, however, there is not as much benefit in improvement of the false negative rates.

It is not possible to determine the appropriate number of challenges per test event without performing a power analysis for each potential scoring grid. The ‘evidence’ for increasing the number of challenges derives from sources that ask the regulatory authorities to, “contract with experts in statistics and test theory, through interaction with knowledgeable cytopathologists and cytotechnologists, (to) design an equitable and scientifically well-founded system,” (Nagy and Naryshkin, 2007). It is not acceptable to base evidence for drastic changes in a nationwide proficiency testing from ‘evidence’ that concedes that dichotomous statistics do not fit our current model of test. (Nagy and Naryshkin, 2007).

Valid statistical modeling brings in theory and practice and should be applicable to current available (or proposed) proficiency test setting. It is not acceptable to base significant changes in proficiency testing on improper statistical applications because it may be the only available evidence at this time or simply because the dichotomous test design is ‘simple, transparent and mathematically calculable’ yet inappropriate for the application to modern proficiency testing. (Nagy and Naryshkin, 2007). Sample sizes will vary based upon the ‘assumptions’ that derive from the statistical analysis, and those assumptions must be valid and the parameters found in the statistical model must be based upon evidence, practice and theory. In addition, testimony at a professional society, without being subject to a peer review process, should also not be considered substantial and statistically valid evidence to change proficiency testing methodology.

REFERENCE:

Nagy GK, Naryshkin S. The Dysfunctional Federally Mandated Proficiency

Test in Cytopathology A Statistical Analysis. Cancer Cytopathol 2007;111:467–76

2)Should annual testing continue tobe required with 10 slides per test?

No. Proficiency testing as now practiced and as currently proposed, is not statistically valid to assess individual performance. Regarding annual testing, there is no published data to support that performance significantly declines over time. The American Board of Pathology (ABP) recommends recertification for pathology proficiency by testing at 10 year intervals. There is no valid data available to support annual (or any other) testing interval. By precedent from ABP recertification, testing intervals can be as great as every 10 years. The Cytology Education and Technology Consortium (CETC) recommends a 5 year interval for cytology proficiency testing.

3)Is 2 years an appropriate testinginterval using 20 slides per test?

Proficiency testing as now practiced and as currently proposed, is not statistically valid to assess individual performance. There is no published data to support that performance significantly declines over time. If proficiency testing continues as proposed the testing interval should be lengthened to 10 years as the American Board of Pathology (ABP) recommends recertification by testing in 10 year intervals. The ABP process is the only other pathology testing program designed to monitor individual proficiency, including cytology proficiency in Anatomic Pathology. The Cytology Education and Technology Consortium (CETC) recommends a 5 year interval for cytology proficiency testing.

4)Why would a testing frequencylonger than every 2 years beappropriate?

Proficiency testing as now practiced and as currently proposed, is not statistically valid to assess individual performance. There is no published data to support that performance significantly declines over time. If proficiency testing continues as proposed the testing interval should be lengthened to 10 years as the American Board of Pathology recommends recertification by testing in 10 year intervals. The ABP process is the only other pathology testing program designed to monitor individual proficiency, including cytology proficiency in Anatomic Pathology. The Cytology Education and Technology Consortium (CETC) recommends a 5 year interval for cytology proficiency testing. The American Board of Medical Specialties implemented the Maintenance of Certification for 24 medical boards utilizing a recertification cycle of 6-10 years.

5)If an individual is allowed to passa 20 cytology challenge test when anHSIL or cancer (Category D) cytologychallenge is reported as Normal orBenign Changes (Category B), how longshould the timeframe be between testingevents?

Proficiency testing as now practiced and as currently proposed, is not statistically valid to assess individual performance. Misclassification or false failure rate for competent individuals drops from 9% with a 10 slide set to 8% with a 20 slide test. If mandatory individual PT is to continue with punitive consequences, there should be no alteration in the interval of testing based upon individual responses to specific challenges. There is no published data to suggest that performance significantly declines over time. If proficiency testing continues as proposed, the testing interval should be lengthened to 10 years as the American Board of Pathology (ABP) recommends recertification by testing in 10 year intervals. The ABP process is the only other pathology testing program designed to monitor individual proficiency, including cytology proficiency in Anatomic Pathology.

6)What type of data should becollected to determine if a longerinterval between testing is appropriate? Who should collect the data? How longshould the data be collected?

Proficiency testing as now practiced and as currently proposed, is not statistically valid to assess individual performance. The current program does not produce data that can be used to support any other testing interval. There is no published data to suggest that performance significantly declines over time. If proficiency testing continues as proposed the testing interval should be lengthened to 10 years as the American Board of Pathology (ABP) recommends recertification by testing in 10 year intervals. The ABP process is the only other pathology testing program designed to monitor individual proficiency, including cytology proficiency in Anatomic Pathology. The Cytology Education and Technology Consortium (CETC) recommends a 5 year interval for cytology proficiency testing. The American Board of Medical Specialties implemented the Maintenance of Certification for 24 medical boards utilizing a recertification cycle of 6-10 years.

Data in support of testing at any interval other than annual would be impossible to gather under the current program, because even looking at individual performance at various yearly intervals does not take into account the fact that the individual actually took the test (and therefore studied/prepped for the test) in the intervening years. Since no population of cytologists exists outside of the current annual testing system, there is no population of practitioners available for study of other testing intervals.

7)What types of data are needed tovalidate testing less frequent thanannually?

Proficiency testing as now practiced and as currently proposed, is not statistically valid to assess individual performance. There is no data currently available to support annual testing, or any other interval of testing, that reflects proficiency in the interpretation of gynecologic cytology. The current program does not produce data that can be used to support any other testing interval.

D. Number of Cytology Challenges

1)Are there logistical concerns andcosts associated with administeringtesting events with more than 20cytology challenges?

Yes, there are logistical concerns and costs of administering more than 20 challenges.

These concerns include, but are not limited to:

Quality control: Any increase over 10 slides/challenges multiplies the staff time proportionally for quality control including QC of slides/challenges, instructions, result forms, evaluations etc.

Fulfillment: Any increase over 10 slides/challenges multiplies the staff time proportionally for design and slide packing if applicable
Testing
Number of consecutive days: The number of consecutive days that a laboratory is allowed to test is of concern. Because the number of slides/challenges may be 20+, it will take more than twice as long for the cytotechnologist to prescreen 10 test slides, and more than twice as long for additional examinees to have their turn with the slides/challenges. The number of consecutive testing days must be increased causing logistical problems with the both laboratories and PT provider. The calculated time needed to test 20 challenges whether they are slides or new technology has not been determined.
Number of examinees per slideset / challenge set: The number of individuals that can be tested using one 20 slideset has not been determined nor has the number of individuals that can be tested using 20 challenges with new technology has not been determined. This is the same for more than 20 challenges.
Time: The time needed per test must be extended. If the estimated time allotted is based upon that for the current 10 slides/two hours model, effectively removing cytotechnologists and pathologists providing patient care services from 2 hours per day, then 20 slides would be at least a half day (4 hours) per examinee and increase proportionally from there. The time needed to calculate how long a laboratory and individuals would need to test with 20 challenges using future technology has not been determined.
Proctors will be taken away from their regular work to engage in administration of gynecologic proficiency testing. Technical supervisors (pathologists), cytotechnologists and other laboratory personnel, such as medical technologists, etc, will be affected by gynecologic proficiency testing administration, ultimately affecting patient care. This will affect all laboratories, especially hard hit will be small laboratories which have limited staff.

Managing the efficient administration of challenges: Based on the current model, if the time were not increased for consecutive testing days, more slidesets would have to be provided per laboratory. More slidesets provided per laboratory requires more cytotechnologist and slide quality control staff to be employed to do review slides between shipments, higher slide costs, etc. The impact of using new technology to administer 20 challenges or more has not been determined.

2)If 20 cytology challenges are used,thereby requiring a 4 hour timeframe toadminister the test, what would be theimpact on the laboratory operation?