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  Q and A






November 2007
PAP/NGC Programs Review

Q. What are the FDA requirements for all cytopathologists and cytotechnologists to be qualified and competent in the use and practice of the Cytyc ThinPrep Imaging System and the BD/Tripath FocalPoint Imaging technology? Must the cytopathologists and cytotechnologists be educated, trained, and certified in the use of these imaging techniques by Cytyc and BD Diagnostics? Does the CAP monitor these requirements in the CAP inspection process?

A. The Food and Drug Administration requires that all cytologists (cytotechnologists and cytopathologists) examining approved liquid-based gynecologic cytology preparations be properly trained and deemed competent. This process occurs through a company-sponsored training program for key individuals in each laboratory. The training process consists of a series of lectures and practical sessions reviewing the technology, morphology, and caveats for the use of each method. A certificate of completion is given to individuals who successfully complete the course. Those trained by the companies in this manner are then eligible to train additional cytologists in their laboratories; however, those trained in a "secondary" fashion (not by the company) are not eligible to perform additional training.

Regarding training for imaging instrumentation, for the Cytyc ThinPrep Imaging System, cytotechnologists (and primary screening cytopathologists) receive training in the use of the review stations, and a certificate is issued for each person who completes the training process. Cytopathologists who are secondary reviewers require no formal training, and no certificates are issued to them. No training or certification process is required for cytotechnologists or cytopathologists for use of the imaging system (slide scanner) itself. The company does provide training for operators of the scanning device.

The BD/TriPath FocalPoint Slide Profiler, in the U.S. at this time, does not involve review stations. Hence the only trainees are device operators, not cytotechnologists or cytopathologists. Operators are trained and certified through a company-run program.

The CAP laboratory inspection process does include a checklist item referring to the training process for the use of liquid-based cytology and imaging devices. It is as follows:

CYP.05264, phase II: Is there documentation of appropriate technical and interpretive training for each of the instruments used? Note: Before the implementation of any automated instrument procedure, staff must receive appropriate training with documented competency. In particular, liquid-based preparation techniques and high-resolution image analysis techniques require both technical and interpretive training by formal external training programs or internal laboratory programs provided by personnel with documented competence.

Any inspection should therefore include an assessment of the certification process for each individual performing such evaluations.

David C. Wilbur, MD
Director of Cytopathology
Massachusetts General Hospital Boston
Chair, CAP Cytopatholgy Committee