In search of a “reasonable person standard” for gynecologic cytologists

Cervical Cytologic Smear False Negative Fraction

“…This parallels the experience reported by Krieger and Naryshkin and others who claim that although FNFs may fall below 5%, they are unlikely to remain below this level: a 5-10% FNF may represent a "floor." [1][2][3][4][7][8][9]15,[18][19][20][21]24,32 A main cause of false negative smears not addressed in this or many other studies is the absence of abnormal cells on the smears themselves due to sampling problems. In this study we dealt only with false negatives due to either the misinterpretation of or failure to detect abnormal cells on the smears.…”

Medicolegal Affairs

“…12 It has been claimed that there are "expert" witnesses who have testified that trivial cell abnormalities should be construed as serious laboratory errors. This may well have occurred, but such cases are usually easily defended by a truly competent expert for the laboratory.…”

“…As we approach the year 2000, cases purporting CC smear misdiagnoses represent one of the fastest-growing areas in medical malpractice law. 11 Following the Wall Street Journal exposé of 1987, Congressional hearings were held, and the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) was passed and subsequently implemented in 1992, 12,13 except for proficiency testing, which has remained an insurmountable logistical problem so far. Substantial coverage of the original congressional hearings on the CC smear was provided by the press, and the media has headlined a number of false negative CC smear cases that have appeared since 1988.…”

“…The final rules of CLIA '88 were implemented in September 1992, but PT still remains an unsolved logistical problem. 12,13 The state of Maryland has the only HCFAapproved PT testing program. The state of New York also conducts PT, but this program is not approved by HCFA.…”

Blinded review of papanicolaou smears

“…Determining the applicable standard in Pap smear cases is difficult and problematic. 4 Although cytotechnologists have provided and continue to provide expert testimony in Pap smear litigation, in a majority of cases it is an expert pathologist who provides these opinions both for the plaintiff and the defense. Although I have rendered this type of opinion, one could challenge that it is not truly expert when the issue is that abnormal cells were not detected during the screening of the slide, in reality a standard that can be legitimately determined only by a cytotechnologist.…”