College of American Pathologists
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  PAP/NGC Program Review





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May 2002
Feature Story

CAP Guidelines for Review of Pap Tests in the Context of Litigation or Potential Litigation

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The Pap test is the most effective cancer screening test in medical history and remains the most effective screening method for the identification of pre-malignant cervicovaginal conditions. The Pap test has been associated with a 70 percent or greater decrease in the United States death rate from cervical cancer.

If the Pap test is to continue as an effective cancer screening procedure, it must remain widely accessible and reasonably priced for all women, including those economically disadvantaged and those at high risk for cervical cancer. There must also be an understanding of the inherent limitations of this screening test.

The Pap test is a screening test that involves subjective interpretations by a cytotechnologist or pathologist of the thousands of cells that are present on a typical gynecologic cytology specimen. Studies indicate an irreducible false negative rate of approximately five percent. Although rescreening can reduce the false negative rate, zero-error performance cannot currently be attained. Many factors, including the subjectivity involved in interpreting difficult cases and sampling problems with specimen collection, prevent zero-error performance.

In the context of litigation and potential litigation, there should for these reasons be an unbiased and scientific method for review of questioned cases that is fair to both the patient and the laboratory. To help effectuate this objective, the College offers the following guidelines for use by courts and attorneys in the review of gynecologic cytology samples in these contexts:

1.  The finding of a false negative in a gynecologic cytology sample is not, by itself, proof of practice below the standard of care. A false negative gynecologic cytology finding can occur—without any negligence—as a result of the subjectivity involved in evaluating difficult cases or as a result of the inadequacy of the specimen.

2.  "Atypical cells of undetermined significance" represent an equivocal interpretive category with poor inter- and intraobserver reproducibility. Therefore, most cases of atypical squamous cells and atypical glandular cells do not represent consistently identifiable abnormalities or a reasonable basis for allegations of practice below the standard of care.

3.  One asserting a violation of the standard of care should first have the Pap test slides assessed by qualified reviewers without knowledge of clinical background and in an environment that simulates normal screening practice. Specifically, such slides should be subjected to an unbiased screening process that includes the contested case material as one or more of a substantial number of normal and abnormal gynecologic cytology samples. The best process is to have the review process conducted by several qualified reviewers. Negligence should not be inferred unless there is a consistent finding by the reviewers that the laboratory failed to identify clinically significant abnormalities.

4.  The standard of care should be that of the reasonable and prudent practitioner. Focused review, or review with knowledge of subsequent development of carcinoma, biases the objectivity of the review. Unless the review is blinded, it cannot establish a deviation from the standard of practice.

5.  Professional expert witnesses who do not have significant experience in cytopathology are not qualified to express an expert opinion on the standard of care. Instead, a court should rely on the testimony of expert physician-witnesses who have, at a minimum, the following qualifications:

  • Maintains a current and unrestricted license to practice medicine in his/her state of practice;
  • Is certified in anatomic pathology by the American Board of Pathology or by an equivalent Board; and
  • Is knowledgeable in the practice of cytopathology as indicated by years of practice experience, current up-to-date continuing education, and active engagement in the practice of gynecologic cytopathology.

    To adjudicate the performance of a cytotechnologist, the court may alternatively rely upon the testimony of expert cytotechnologist witnesses who have, at a minimum, the following qualifications:

  • Maintains a current and unrestricted license to practice if licensure is required in the state in which the cytotechnologist practices;
  • Is certified as a cytotechnologist by the ASCP Board of Registry; and
  • Is knowledgeable in the practice of cytotechnology as indicated by years of experience, current up-to-date continuing education, and active engagement in the practice of cytotechnology.

6.  Compensation of the witness should reasonably reflect the time and effort expended in preparation, depositions, and trial. Compensation of an expert witness contingent on the outcome of the case introduces the possibility of bias and should not be permitted.

7.  The parties should also strongly consider mediation or non-binding arbitration by a panel of individuals trained and having experience in cytopathology before proceeding with civil litigation relating to a Pap test. Such panels could be developed through national societies with interest and experience in gynecologic cytology.