Guidelines for Review of Pap Tests in the Context of Litigation or Potential Litigation
Pap test slides being assessed in conjunction with litigation or potential litigation should be reviewed without knowledge of clinical outcome and in an environment that simulates the normal screening practice. A finding of a false negative Pap test is not necessarily evidence of practice below the standard of care. A physician-witness should have significant experience in cytopathology and should not be compensated contingent upon the outcome of the trial. Potential parties to litigation should strongly consider mediation or non-binding arbitration by an expert panel prior to proceeding with civil litigation.
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% 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 interpretation by a cytotechnologist and/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 5% because some cases contain uncharacteristically few abnormal cells or cells that are not typical of dysplasia or cancer. A zero-error performance cannot be attained.
In the context of litigation and potential litigation, there should be an unbiased and scientific method for review of questioned cases that is fair to both the patient and the laboratory. To help attain this objective, the College offers the following guidelines for use by courts and attorneys:
- 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.
- Atypical cells of undetermined significance represent an equivocal interpretive category with poor inter- and intra-observer 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.
- Before asserting a violation of the standard of care, complainant 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 evaluation conducted by several qualified reviewers. Negligence should not be inferred unless there is a consistent finding by the reviewers that the laboratory or practitioner failed to identify clinically significant abnormalities.
- 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.
- 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 upon 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 or equivalent; and
- Is knowledgeable in the practice of cytotechnology as indicated by years of experience, currently up-to-date continuing education, and active engagement in the practice of cytotechnology.
- 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.
- 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.
Adopted February 1998
Reaffirmed February 2001
Reaffirmed August 2001
Revised November 2001
Reaffirmed October 2005
Revised April 2012