CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Onboarding in gyn and nongyn cytopathology
Barbara A. Crothers, DO
Janie Roberson, SCT(ASCP)CM
Kelly Goodrich, CT(ASCP)
January 2019—It is happening again: CAP members and cytotechnologists are asking about regulatory requirements for re-integrating into cytopathology after a period of practice latency.
That is good news because it indicates that they are interested in practicing at a time when the cytopathology community can use skilled professionals. The past decade has seen a shrinking volume of Pap tests and a concomitant decline in the number of practicing cytologists, which has created new job opportunities for those with cytopathology skills. Whether the practitioner is new to the field, new to an employer/laboratory, or back in the field from a period of latency, onboarding is a critical component of ensuring competency and good laboratory practice.
Let’s attack the regulatory issues first: specifically, how they apply to gynecologic cytopathology.
The Centers for Medicare and Medicaid Services CLIA ’88 regulations at section 493.855(a) say that a laboratory “must ensure that each individual engaged in the examination of gynecologic preparations is enrolled in a proficiency testing program approved by the Centers for Medicare and Medicaid Services.” As of 2018, there were only two approved Pap PT programs: the CAP and American Society for Clinical Pathology programs.
Who needs to take the Pap PT? Any individual who primarily examines and/or interprets (even one!) Pap test for clinical purposes during a calendar year.
Who is exempt from Pap PT? Researchers are exempt, as are the following:
- Trainees (cytotechnologists, residents, and fellows)—exempt up to and including the calendar year of graduation.
- Individuals who examine or interpret only nongynecologic specimens.
- Individuals who are using previously reported Pap test slides for teaching.
- Individuals who are reviewing Pap test slides solely for the purpose of presentation to tumor boards or planning conferences without an intended change in Pap test diagnosis.
The guiding principle is that if the individual is making an assessment of a Pap test for a diagnosis or for interpretation to provide information that can be used toward a diagnosis, he or she must participate in PT. For example, if a pathologist who does not interpret Pap tests reviews a Pap test slide for a tumor board and does not disagree with the diagnosis, she may present the findings at tumor board. However, if she disagrees with that interpretation and seeks changes in the diagnosis, then she is influencing patient care and should be proficiency tested. Similarly, any individual who is reviewing Pap tests and requests a revision of the primary cytologist’s interpretation of the Pap test should be proficiency tested, even if he or she does not primary screen or sign out cases.
Individuals who fail the initial Pap PT must retest with a two-hour, 10-slide test within 45 days of notification of that failure. There is no requirement that previously examined slides from that individual be rescreened.
Individuals who fail the second retest must obtain documented remedial training “in the area of test failure” and pass a four-hour, 20-slide PT. There is no time interval required to take the test other than that it must be in that calendar year. Remedial training can be in the laboratory and focus on cases that were misinterpreted. For example, if an individual calls a slide with HSIL as NILM, he or she can focus re-education on slides and courses on HSIL. In addition, all Pap tests screened/signed out by that individual prior to the test failure date must be re-examined. If an individual fails this third test, he or she must cease examining Pap tests from the date of failure notification and obtain 35 hours of documented, formal continuing education in diagnostic gynecologic cytology.
However, it’s not “three strikes and you’re out.” Those who fail the third test can complete as many cycles of testing (using the third test algorithm) as necessary to pass. Importantly, the individual must pass for that calendar year. If for some reason testing extends into the next calendar year and the individual passes, he or she must take a new initial 10-slide PT for the new calendar year. In addition, the individual must pass the calendar year PT in the program selected for that calendar year and cannot switch programs, hoping for an easier test, until he or she has passed the original PT program.
The regulations require that each individual pass an annual PT for the year(s) in which he or she practices. Individuals must complete initial testing by Dec. 31 of a given year, but the retesting can extend into the following year, to be completed no later than April 2 of that year.