Negligence in Interpretation of Pap Smears

Historical  Perspective

In 1987, Van der Graaf, Y., et al., reported striking findings concerning screening errors in cervical cytoloty. In a screened population of 165,185 women, 555 women demonstrated "moderate dysplasia" or a higher lesion, three years after a negative screening. An examination of the slides previously read as negative showed that the adequate smears all were misread. Fully 1/3 represented "dysplasia" or a carcinoma in situ. According to Dr. Koss, in those cases contained in the literature where prior negative smears of patient with invasive cancer are examined, cancer cells are apparent on review.

In 1961, at a time when few American women were being screened, the incidence of cervical cancer was 33 per 100,000. By 1987, when the population of women screened at some time during their lives reached 80%, the incidence of squamous cell carcinoma of the cervix dropped to 8.3 per 100,000. The rate of cervical cancer, in countries where screening does not occur, continues at the same rate as that of industrialized countries before the initiation of large-scale screening programs. It is obvious that screening programs have greatly reduced the incidence of the disease. However, the continued occurrence of cervical cancer in the screened population suggests that inadequate screening occurs or that the screening process is inherently incapable of identifying a significant percentage of women with disease prior to the occurrence of invasive cervical cancer. It is this author's position that the occurrence of 8.3 cases per 100,00 is due to inadequacies in the screening process. That inadequacies exist is well borne out by the literature. It is these inadequacies which are the subject of this paper.

Can Advanced Cancer and Deaths be Prevented by Pap Smears?

The object of reducing the occurrence of false-negative Pap smears has been a major focus of legislative reform and of ongoing quality control programs throughout the country. Whether the 4900 annual excess deaths from cervical cancer are subject to further reduction has been questioned by some authors recently. Frabel and others focus primarily on the perceived plight of the cytotechnologist, cytopathologist or laboratory, or the assumed increased cost which would result from any significant improvement to the existing system. , DeMay argues that cytologists are being held to an impossible standard of perfection in malpractice litigation and that a zero error standard is both unreasonable and impossible to achieve in practice. The legal system does not demand perfection. The legal system does demand that cytotechnologists and cytopathologists perform in conformity with those principles of practice about which there is uniform agreement. From a legal perspective, a zero error standard is reasonable, whether or not it is possible to achieve in practice. All standards of practice must be at least theoretically obtainable. If it were theoretically impossible to perform in a certain manner in practice, such performance would not be a standard to which any professional would be held. We do not ignore in our culture the incidence of carelessness simply because it is supposed that human beings will, on occasion, be careless.

The cytopathologist can have a far-reaching role in reducing morbidity due to cervical cancer. This role is not limited to interpreting properly Pap smears submitted for review. The cytopathologist also has a responsibility to inform those submitting smears of the adequacy of the smears and to submit reports in a comprehensive and comprehensible form, together with recommendations for future management (diagnostic evaluation).