EDITORIAL Section Edituc Tilde S. Klne

Can Anyone Offer Some Good News About Cytology? I Think I Can, I Think I Can Beverly Balfour Kraemer, M.D.

“The little train rumbled over the tracks. She was such a happy little train for she had such a jolly load to carry . . .”

from The Little Engine That Could, Watty Piper, 1930’

Gone are the simpler days when the practice of cytology was an enjoyable intellectual pursuit carried out with quiet circumspection. Recent events have forever ended such an environment. The demonization of professionals practic- ing cytology entered a new dark age with the news sur- rounding a Wisconsin laboratory. Recommendations were made by an inquest jury that homicide charges be brought against laboratory personnel who committed false negative diagnoses on two patients’ Pap smears. More fatal errors. More bad press splattered in headlines. Criminal cytologists at their microscopes.

More than ever before, recognizing the value of cervical cancer screening along with the appropriateness of a “rea- sonable person standard” must be vigorously reinforced among women, their physicians, the legal community, and the press. The seriousness of this effort cannot be over- stated. At the same time, however, it seems necessary to counter some of the unsavory aspects of our specialty with a retrospective review of a different kind that emphasizes some positive attributes of cytology. Better check your mike, Diane Sawyer,

“I’m not very big,” said the little blue engine. “I have never been over the mountain.”

In 1988, a small and dedicated group of pathologists from the College of American Pathologists formed a task

Received May 16, 1995. Accepted May 16, 1995. From the St. John’s Mercy Medical Center, St. Louis, MO. Address reprint requests to Beverly Balfour Kraemer, M.D., St.

John’s Mercy Medical Center, 615 South New Ballas Rd., St. Louis, MO 63 141 -8277.

force committee for the express purpose of developing and implementing a quality improvement/educational pro- gram in gynecologic cytology. (The founding members of the Task Force Committee were Drs. Diane Davey, Wil- liam Fidler, B.B. Kraemer, David M. Lowell, Mary Nielsen, Donald Penner, and Henry Travers.) The com- mittee was given 1 year in which to accomplish this goal. Building upon the work of Penner, a program was de- signed to address diagnostic accuracy as well as to provide an educational element. The program material would consist of actual Pap smears, which would be selectively contributed by laboratories throughout the country. All slides would be referenced prior to use in the program.

‘‘slowly, slowly, they started off.” I

After much preparation, the pilot program known as “PAP” was launched, and 207 laboratories participated. This activity occurred in close proximity to other major developments in cytology, including the enactment of CLIA ’88, the publication of the Bethesda System, and the administration of the first American Board of Pathology examination for subspecialty qualification in cytopa- thology.

The pilot was soon converted to a full-fledged program. The train had left the station, so to speak. There were ongoing concerns that the program would not be able to keep pace with the ever increasing numbers of partici- pants, and that suitable slide material would be increas- ingly difficult to acquire. Despite these obstacles, the Col- lege supported the program to the fullest extent possible, and every person involved became totally committed to the program’s success. The organizational framework for the program was formally expanded to focus upon mate- rial acquisition, data analysis, strategic planning, and leg- islative impact issues. Internationally renown cytopa- thologists became members of the committee overseeing the program. These individuals drew upon their expertise to further refine the program, and contributed countless

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hours of service. In addition, cytotechnologists were often invited to participate in slide review sessions. To promote a unified effort, liaisons were established with the National Cancer Institute, American Society of Cytology, Ameri- can Society of Clinical Pathologists, and the American Society for Cytotechnology.

What was once a slow struggling little engine had become a bullet train. As of 1994, there were 1,790 labora- tories participating in the program, serving 3,700 patholo- gists and 3,600 cytotechnologists, with international par- ticipants from Aruba, Australia, Bermuda, Canada, Japan, Saudi Arabia, Singapore, South Africa, and Tai- wan. The cumulative results of the program were recently p~b l i shed .~ The most important findings were: 1) reaffir- mation that an irreducible false negative rate remained (5%) ; 2) the consensus or hierarchical laboratory response had a higher concordance than either the independent pathologist or cytotechnologist response; and 3) experi- enced participants had fewer diagnostic errors.

The PAP program established a series of firsts. It was thefirst to incorporate Bethesda System terminology in a quality assurance program, including specimen adequacy and diagnostic categories. It was theflrsf to exploit fac- simile transmission technology for immediate educational feedback (which over 90% of the participants routinely use). It was thefirst to employ a novel approach for slide acquisition by requiring participants to send in glass slides from their own departmental files each year in order to maintain their enrollment in the program. And it was the first to utilize a collaborative approach at multiple levels in order to achieve a successful outcome.

“Here comes a shiny new engine. Let us ask him to help US."^

With the advent of telemedicine and other develop- ments in informatics, image-based quality assurance pro- grams may become feasible in future years. Diagnostic imaging and communication standards must first be put in place, and the information age skills of target users must be sufficiently advanced to permit this technology transfer. Will it be possible to assess locator and interpre- tive skills using an artificial image-based method? Tech-

nology of this type applied to quality assurance programs may become a reality only if significant obstacles can be overcome. Resource allocatian and patient driven demand will greatly influence whether these shiny new engines with all their bells and whistles ever leave the roundhouse. This scenario is contrasted with current practices in other areas of the world, such as the former Soviet Union, where startling acts such as throwing negative Pap smears in the trash after they are reported, or scraping the cells off the slide so that the glass slides can be used again are routine. * The vast majority of cytology laboratories have quality assurance programs that fall between these two extremes, relying on basics such as glass slide-based interlaboratory comparison programs as a cornerstone of their overall laboratory quality assurance. ’The validity of these inter- laboratory programs has been well documented. Their utility must not be derailed at the expense of other new methods until the advantages over currently accepted pro- grams become clear and undisputed.

The practice of cytology may be reported upon in vari- ous ways, from bleak media portrayals which receive the public’s attention, to more positive documentaries of irn- proved diagnostic accuracy, which largely go unnoticed. Clearly, there will be other stories about the little engines that could. Their stories should be told. After all, you can’t tell which way the train went just by looking at the track. These accounts will give inspiration to our specialty and fortify our efforts, even in times when human judg- ment intervenes and pulls our train of thought toward the switch yard.

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Piper W. The little engine that could. New York: Platt and Munk, 1930, Associated Press. Homicide charges urged after misread Pap tests. New York Times 1995 April 1 1 ; B7. Derman H, Koss LG, Hyman MP, Penner DW, Soule E, Hicklin MD. Cervical cytopathology. I. Peers compare performance. Pa- thologist 1981;35:317-325. Davey DD, Nielsen ML, Frable WJ, Rosenstock W, Lowell DM, Kraemer BB. Improving accuracy in gynecologic cytology. Results of the College of American Pathologists interlaboratory comparison program in cervical cytology. Arch Pathol Lab Med 1993; 117:1193- 1198. Allen K. Cytotechnologists witness history during “Moscow Cri- sis.” ASCT News 1995;15:1-4.

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