I am amazed that there has been little commentary about the cytology PT over the past year. Perhaps this is most likely due to the fact that CMS "...will not fail cytology PT, have deficiencies cited, or have sanctions imposed against their CLIA certificate provided they:

1. Enroll all affected individuals in a Centers for Medicare & Medicaid Services (CMS)approved testing program for the CY 2007 testing cycle, and
2. Ensure that all such individuals are tested in a timely manner within 2007, in accordance with the regulatory protocol.

The regulatory protocol under 42 CFR 493.855 identifies the extent to which additional testing, education, or limitations must be put in place with regard to individuals who do not pass the test initially."

This is a good thing

In addition, I personally feel that the anxiety has somewhat passed, allowing people to perform better with less anxiety, and in addition, there are multiple players now in the "testing" market, which allows for our choice of "pill".

I have now taken both MIME (now ASCP) and CAP versions of the test, and found no significant differences between the two. I had some issues with MIME as well as CAP, but not anything that wasn't easily fixable by contacting the vendors.

The most challenging aspects are the documentation and educational efforts needed in order to comply with the intent of the regulation, which is nothing new. I think that is the general trend right now, and again, although not a bad thing in general, difficult to consistently apply in our current state...doing more with less and in the same amount of time.

It will be interesting to follow the resulting effects of the Cytology PT Act of 2007, to see how this will affect our existing testing format.

I would like to hear feedback from others...perhaps because I get lonely...but perhaps, so others can share their experiences and viewpoints. In addition, I expect that we in the US may be viewed differently than we may think, as our colleagues abroad have long been under the watchful eye of the government, and in many respects, under the auspices of a structured national quality assurance program. Perhaps we have much to learn...remember...it isn't all about us

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Having survived the initial MIME Cytology PT test in September, and first retest in October, we were very much relieved to be done with our PT testing until the following fall. And, dancing with glee as we signed up for the CAP version, we sat back, satisfied that we had survived the initial round of CMS mandated cytology PT. Yesterday, we received notification from CAP that our cytology PT test was scheduled for February 2006!!!

LOL....well, I am still considering what we will do. I suspect that I will recommend we go ahead and take in order to get it over with, as well as to evaluate the CAP version. Then going forward, we will be able to choose which program to utilize with actual experience with both.

I am curious if anyone received notice of testing even earlier than Feb? Post here....I would welcome anyone's experience with the CAP Cytology PT test.

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By hao-chien  on Tue 22 of Nov, 2005 14:08 UTC

hi all! im a very new user looking for some guidance to good use of this site to increase my cytological mindedness!! i want to know how to access to the PTs fast, since i really want to test out whats more than that all in the books. cheers..

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Our lab participated in the MIME Cytology PT Exam last week. Both pathologists and cytotechnologists participated in a combination of online kodachrome exams and mock glass slide exams prior to the actual test in preparation. Although anxious, everyone felt relatively prepared for the test.

I was the first to take the exam of our pathologists as I probably felt the most comfortable. Well, what a surprise! I received a set of previously screened slides, and come to find out, from one of our most senior cytotechnologists with excellent skills. After looking at the first slide, where we disagreed, Tech-HSIL, PATH-NEG, I decided to move on to the next slide. Wow, Tech-HSIL, PATH-NEG. Ok, so I thought, well, let's look at the next slide...Tech-HSIL PATH-LSIL. I am thinking...ok, my goose is cooked. One of us is having a very bad day.

What I realized was that this test had nothing at all to do with the actual content of the slide, and whether one has correctly identified the area in question, but had more to do with trying to figure out what the Test Providers were looking for. I came to the conclusion that my cytotechnologist was doing what they felt they had to do in order to pass the exam, just in case they guessed wrong, even though, they clearly saw the abnormality (or something that perhaps MIME might consider an abnormality). In the end, I went with what I would do in daily practice, deciding that if that wasn't what they were looking for on the Exam, I would challenge the question. If I wasn't going to pass, I was going to do so on principle. So either I got them all right, and we both passed, or I failed and the cytotechnologist passed. We will see....most of the other pathologists experienced something very similar.

IMHO, this test is flawed, and does not accurately assess an individuals ability to correctly identify an abnormality on the slide. It seems to be testing the performance of the slide in a testing arena. And, the cytotechnologist is graded in a fashion that considers the evaluation a "screening" interpretation, where in contrast, the pathologist is graded in a fashion that considers the evaluation a "diagnostic" interpretation (ie. an HSIL incorrectly called LSIL is a 5 point deduction, whereas for a cytotechnologist, there is no point deduction). Ok, so, I am confused....is the PAP test a "screening" test, or a "diagnostic" test?

And finally, a couple more things. Firstly, the logistics of this entire process is yet to be fully recognized, either by the labs OR by CMS. DOCUMENT EVERYTHING. Did you know that you also have to have a letter signed by the Medical Director and the individual who is NOT doing GYN screening? And that CMS/MIME have to be notified of this? And I am assuming CAP? Secondly, I am extremely irritated and perplexed that a poorly designed 10 slide exam where I can miss only one question, can prevent my ability to examine PAP smears, when I am a Board-certified cytopathologist with many years of experience. So, a government mandated 10 slide test can OVERRIDE an American Specialty Board exam. WOW.....what next??? Lastly, I do not know yet whether I passed or not....and really, the point is moot. What is important is that Congress moves to suspend this testing for re-evaluation. I am happy that CAP received their approval, but overall, the testing needs to be suspended and its process and current need reviewed.

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I have posted a general information test on the CYTOPATHNET Campus to assist with Cytology PT preparation and familiarity. I am hoping to get a mock kodachrome slide set up soon. Go to http://campus.cytopathnet.org and choose the Cytology PT Exam course.

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By Cytonana  on Tue 21 of Jun, 2005 22:48 UTC

Cytology is in a sad state.

I think this is just more thing... for us to keep up with while at the same time trying to screen 60 to 80 slides per day.

I think that interpretations skills are measured by the federal registery exam.

What good is Proficiency testing when techs are told that they must screen 60 to 80 slides per day just to keep the Cytology lab viable. I think that the CLIA workload limits have seriously backfired.

How can daily screening proficiency be measured if the test allows one to take more than twice the amount of time he/she is allowed to take during a normal work day for each slide?

To measure screening & interpretation skills under normal working conditions, I think the individual "maximum workload limit" set for each tech should be put to the test. (ie. If it is 12.5 slides / hour, then the tech should be able to show proficiency at that rate). If this were the case, managers would not be so inclined to insist on unreasonable min/max workload limits for the techs.

I feel that many techs rather than screening in a manner that will insure that abnormal cells are detected, are forced to use thier microscope stage as a self propelled assembly line figuring out just how fast the knobs must be turned to insure 60, 80 or 100 per day quotas. I've never used an automated screener, but I shudder at the thought of having to crank out 150 to 200 cases per day.

Sincerely, Cytonana

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For the past 16 years, the CAP checklist question regarding Cytology PT was usually addressed by participation in either CAP PAP, ASCP Star, or MIME CytoQuest? programs. Technically, however, as we are all aware, these programs did not represent "true" cytology proficiency testing as defined by CMS. As the result of CMS finally approving MIME for Cytology PT, there now exists a "true" cytology PT program. The prior programs, CAP PAP, ASCP Star and MIME CytoQuest? represent "educational programs". I am providing excerpts from the most recent CAP Lab General checklists http://www.cap.org/apps/docs/laboratory_accreditation/checklists/laboratory_general_march2005.pdf which address these areas as they may NOW also relate to Cytology PT testing. The first question should NOT apply to cytology PT as this IS a required PT enrollment. It will be interesting to see how this is interpreted by inspectors.

• REVISED** 03/31/2004

GEN.10500 Phase II N/A YES NO For tests for which CAP does not require enrollment in PT, does the laboratory at least semiannually 1) participate in external PT, or 2) exercise an alternative performance assessment system for determining the reliability of analytic testing? NOTE: Appropriate alternative performance assessment procedures may include: split sample analysis with reference or other laboratories, split samples with an established in-house method, assayed material, regional pools, clinical validation by chart review, or other suitable and documented means. It is the responsibility of the laboratory director to define such alternative performance assessment procedures, as applicable, in accordance with good clinical and scientific laboratory practice. As an example, the biannual CAP CED educational challenge in esoteric coagulation testing offers an opportunity to compare test results with other participants. Participation in ungraded/educational proficiency testing programs also satisfies this checklist question. COMMENTARY: N/A

• REVISED** 03/31/2004

GEN.10000 Phase II N/A YES NO Are the laboratory’s procedures for proficiency testing written and sufficient for the extent and complexity of testing done in the laboratory? NOTE: CAP-accredited laboratories must participate in proficiency testing (PT) (when available through CAP or a CAP-approved alternate provider) for all patient tests designated by CAP. The current list of analytes for which CAP requires PT is available on the CAP website http://www.cap.org/apps/docs/laboratory_accreditation/ptgraded.html or by phoning 800-323-4040 (or 847-832-7000), option 1.

The laboratory must have written procedures for the proper handling, analysis, review and reporting of proficiency testing materials. There must be written procedure(s) for investigation and correction of problems that are identified by unacceptable proficiency testing results. The laboratory should also have procedure(s) for investigation of results that, although acceptable, show bias or trends suggesting a problem. The CAP office audits PT participation to assure that accredited laboratories participate in PT as appropriate. College of American Pathologists Revised: 03/30/2005 LABORATORY GENERAL (Web File) Page 7 of 7 COMMENTARY: N/A

• NEW** 03/31/2004

GEN.11484 Phase II N/A YES NO Are records of all proficiency testing since the last on-site inspection complete? NOTE: Records must include worksheets, instrument tapes, reporting forms, evaluation reports, participant summaries, and documentation of follow-up, as applicable. COMMENTARY: N/A

GEN.11742 Phase II N/A YES NO Is there written evidence that all problems identified by proficiency testing and alternative performance assessment have been recognized and corrected? COMMENTARY: N/A

GEN.12258 Phase II N/A YES NO Is there a policy that prohibits interlaboratory communication about proficiency testing samples before submission of data to the proficiency testing provider? NOTE: Under CLIA-88 regulations, there is a strict prohibition against communications about proficiency testing samples before submission of data to the proficiency testing provider. The laboratory director is responsible for enforcing this prohibition. COMMENTARY: College of American Pathologists Revised: 03/30/2005 LABORATORY GENERAL (Web File) Page 9 of 9 N/A REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7146 42CFR493.801(b)(3); 2) Bierig JR. Comparing PT results can put a lab’s CLIA license on the line. Northfield, IL: College of American Pathologists CAP Today. 2002;16(2):84-87.

GEN.13032 Phase II N/A YES NO For tests performed within the laboratory, is there a policy that prohibits referral of proficiency testing specimens to another laboratory? NOTE: Under CLIA-88 regulations, there is a strict prohibition against referring proficiency testing specimens to another laboratory. It is the responsibility of the laboratory director to ensure that this prohibition is enforced. COMMENTARY: N/A REFERENCE: Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28): 42CFR493.801(b)(4).

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For anyone reviewing their certification status in order to address cytology PT issues, please refer the information below from the CMS website.

CMS has made available the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Application for Certification, Form CMS-116. This form should be mailed to the address of the local State Agency for the State in which your laboratory resides. (The form is in an Adobe Acrobat file (form116.pdf) and requires the Adobe Acrobat reader software to view. The file contains the following-- Form CMS-116 (PDF 33K), Instructions for Completion, Guidelines for Counting Tests for CLIA and Tests Commonly Performed and Their Corresponding Laboratory Specialties/Subspecialties, http://www.cms.hhs.gov/forms/cms116.pdf.

CLIA requires all entities that perform even one test (NOTE: emphasis mine, ie. hospital-based pathologists who maybe review 3-4 paps per year), including waived test on ... "materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.

The CLIA application collects information about a laboratory's operation, which is necessary to determine the type of certificate to be issued and the fees to be assessed.

NOTE: Your completed application should be forwarded to the address of the local State Agency for the State in which your laboratory resides. If you have any questions regarding the completion of the Form CMS-116, contact the appropriate State Agency as noted above. You should also contact this State agency for additional forms that may be necessary to complete the registration process or for any additional questions. For example, the State of California has additional licensure requirements and thus California applicants should be sure to contact their local State Agency --(213) 833-6000. Be sure to make contact with your State Agency to ensure that you have all the necessary information that is required for application.

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The Transcript and Audiotapes from the CAP Conference on CMS Cytology PT testing have been posted. They are available at the following links:

• Transcript from February 24 CAP audioconference on cytology PT ( http://www.cap.org/apps/docs/disciplines/cytopathology/final022405Transcript.html

• Listen to streaming audio of February 24 CAP audioconference on cytology PT
  • Presentation (rtsp://www.cap.org:554/cms022405.rm), RealAudio? Stream
  • Q&A (rtsp://www.cap.org:554/cms022405q.rm}

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