Pamela C. Gibson, MD

Elizabeth M. Kurian, MD 

 

Are you prepared to show certification of formal liquid-based cytologic training at your next lab inspection? Have you provided your trainees the opportunity to leave your program with such documentation?

The ThinPrep® Pap Test received FDA approval as a new liquid-based methodology for cervical cancer screening while one of us (PCG) was in training. Upon graduation, I had the opportunity to go to the former Cytyc Corporation in Marlborough Massachusetts (now ThinPrep® Hologic Inc.) to be trained on-site. It was a memorable learning experience to screen approximately 80 Pap tests in one day, side-by-side with one of our cytotechnologists; for the sheer volume and the invaluable opportunity to immediately compare with the follow-up cervical biopsies. After passing the morphology training test, we received a training certificate and luckily I provided a copy of the certificate-of-training to the cytology supervisor upon my return.

Years later this came in handy when asked by an external laboratory inspector to produce documentation that I was properly trained on the liquid-based cytology morphology, which we were using in our laboratory. In fact, they asked for certification of ALL the pathologists. Since many in our group had been trained either at Cytyc Corp. or by the train-the-trainer method, we were able to produce the documentation immediately (or by contacting the company who also kept records of the training).

I had long forgotten about the certificate (but not the training experience). As an institution with an active residency, cytopathology fellowship, as well as a prior certified cytotechnology training program; the University of Vermont had instituted the ThinPrep® Train the Trainer program. Our (PCG, EMK) academic institutions have been formally training, testing and providing certification for our cytology trainees and residents participants. However, this practice does not seem universal. In my (PCG) experience, when I have asked new faculty for their training certificates, they are surprised that we need the certificate. Several pathologists were unable to provide this documentation despite graduating from an accredited cytology fellowship program that use the same training methodology.

I became acutely aware of the requirements during that inspection and further investigated the rules behind this requirement. When the ThinPrep® and BD SurePath® (formerly AutoCyte®) liquid-based Pap Tests were approved by the Center for Devices and Radiologic Health of the Food and Drug Administration (FDA) for cervical cancer screening, the approval included the necessity for proper morphologic training of individuals interpreting the slides. The training would include a proficiency examination, as indicated in their product material manuals/inserts for the tests (1,2). This is directly supported by the need to “maintain documentation of appropriate training of personnel” under the Clinical Laboratory Amendments of 1988 (CLIA’88) (3) and the College of American Pathologists as a deemed entity (4) and New York State Wadsworth Laboratory Accreditation Program (5).

The literature, interestingly, is limited with respect to the utility of this training in changing patient outcomes. It is recommended that cytotechnologists seek out this training if they have been out of the workforce for a period of time (6). Dr. Renshaw and colleagues in 2006 published (for the Cytopathology Resource Committee of the College of American Pathologists) a comparison of individuals who were certified and those who said they were not certified in liquid-based cytology. The results implied that those who had been trained on liquid-based cytology (with certification) had a significantly lower discordant rate in the interpretation of the liquid-based cytology tests (7).

Programs/institutions need to consider how they train their trainees in the future. A laboratory member trained directly by the company may certify others within the laboratory. However, after 20 years of using the liquid-based pap tests, many of the prior trainers in the “train the trainer” format are getting close to retirement age. Hologic, Inc (ThinPrep) and Becton, Dickinson, Company (BD; Surepath) both offer direct training with instructional slides and test slides for customers – laboratories must contact the company to arrange for this training.

Regardless of the methodology, individuals need formal certification during their training or prior to starting their new jobs, as routine clinical lab regulations require this documentation. While this is not an ACGME requirement, fellowship programs that do not currently certify their fellows in liquid-based methods should consider doing so as a service to their fellows and the wider cytology community.

References:
1) Introduction and Chapter 11 , ThinPrep® Pap Test Training Program, Hologic ThinPrep® 5000 Processor Operators manual , Hologic Inc, Marlborough, Massachusetts 2017. https://www.hologic.com/sites/default/files/2018-05/MAN-02203-001_003_02.pdf
2) Introduction, BD Totalys™ Package Insert. BD Becton, Dickinson, and Company, Sparks Maryland 2016.
3) Code of Federal Regulations CFR, Title 42, Chapter IV, Subchapter G, Part 493, Subpart M, 493.1407 (e) (11) Standard; Laboratory director responsibilities. https://gov.ecfr.io/cgi-bin/text-idx?SID=5661aa1084e0ff0d93003a839ab8c110&mc=true&node=pt42.5.493&rgn=div5#sp42.5.493.m
4) College of American Pathologists. CAP Accreditation Checklist 2018 Laboratory General Checklist GEN.55450 Personnel Training.
5) New York State Department of Health, Wadsworth Center, Clinical Laboratory Evaluation Program, Clinical Laboratory Standards of Practice. Human Resources Sustaining Standard of Practice 6 (HR S6): Training. https://wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards
6) Friedlander MA. Re-entering the field of Cytotechnology. ASCT Bulletin. https://www.asct.com/docs
7) Renshaw AA, Mody DR, Walsh M, Bentz JS, Colgan TJ. The Significance of Certification in Liquid-Based Cytology and Performance in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytopathology. Arch Pathol Lab Med 2006;130: 1269-1272.

Pamela C. Gibson, MD
Associate Professor of Pathology and Laboratory Medicine
University of Vermont Medical Center and Larner College of Medicine at UVM
Burlington, Vermont

Elizabeth M. Kurian, MD
Associate Professor
University of Texas Southwestern Medical Center
Dallas, Texas