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LIA-025: Pap Smear Screening

Pap Smear Screening: The Wisconsin Medical Society supports the following guidelines for review of pap smears in the context of potential litigation:

The pap smear is the most effective cancer screening test in medical history and has been associated with a significant decrease in the death rate due to a prevalent cancer in the United States. If the pap smear is to continue as an effective cancer screening procedure, it must remain widely accessible and reasonably priced for all women, including those with low incomes and those at high risk.

It must be recognized that the pap smear is a screening test that involves subjective interpretation by screening cytologists of the 50,000-100,000 cells that are present on a typical pap smear. Even the best laboratories have an irreducible false negative rate. Although rescreening can reduce this rate, zero-error performance can never be attained as the result of many factors, but particularly due to both the subjectivity involved in making diagnostic determinations in many difficult cases and because of inherent imprecision in the process of specimen collection.

The finding of a false negative pap smear is not necessarily evidence of practice below the standard of care. Whether a false negative smear is the result of negligence must be judged not only on the basis of the individual result, but also in context of overall laboratory performance on pap smears.

The diagnosis, atypical cells of undetermined significance, represents a poorly defined entity with poor inter- and intra-observer reproducibility. Therefore, disputed case of atypical cells of undetermined significance are not likely to represent reasonable groups of allegations of practice below the standard of care.

Pap smear slides assessed for possible litigation should be reviewed without knowledge of clinical outcome. This review should simulate the normal screening situation as closely as possible. This may be accomplished as a screening process including the contested case as one of a number of pap smears representing a variety of disease states. Review with knowledge of subsequent development of carcinoma biases the objectivity of the review does not reflect standard practice.

A court reviewing the qualifications proffered by physician-witnesses should consider or utilize these prerequisite criteria:

  • The physician maintains a current and unrestricted license to practice medicine in his/her state of practice.
  • The physician is certified by the appropriate ABMS specialty or subspecialty board.

The standard of care should be that of the reasonable and prudent practitioner. Courts should recognize that a false negative result is not sufficient proof of negligence. Rather, they should look to whether overall pap smear practices of the laboratory meet the standard of care.

Compensation of the physician-witness should reasonably reflect the time and effort expended by the witness in preparation, depositions and trial. Compensation of a physician-witness contingent on the outcome introduces the possibility of bias and should not be permitted. (HOD, 0410)*

*Currently under five-year policy review.