GUIDELINES FOR REVIEW OF PAP SMEARS IN THE CONTEXT OF LITIGATION OR POTENTIAL LITIGATION

The following is the text of Guidelines formally adopted by the College of American Pathologists in February of 1998.  The CSC Executive circulated these guidelines to the membership for comment and approval. The guidelines were approved unchanged in January, 2001.

The following guidelines should be used for review of Pap smears for litigation or potential litigation.

1. The finding of a false negative smear is not necessarily evidence of practice below the standard of care.  The decision as to whether a false negative smear is the result of negligence should be made not only on the basis of the individual result, but also in the context of the laboratory’s overall performance on Pap smears.
2. Atypical cells of undetermined significance represent a poorly defined diagnosis with poor inter- and intra-observer reproducibility.  Therefore, disputed cases of ASCUS (atypical squamous cells of undetermined significance) and AGUS (atypical glandular cells of undetermined significance) are not likely to represent reasonable grounds for allegations of practice below the standard of care.
3. Pap smear slides being assessed for possible litigation should be reviewed without knowledge of clinical outcome and in an environment that simulates the normal screening practice as closely as possible.  This may be accomplished through an unbiased screening review process that includes the contested case as one of a number of normal and abnormal Pap smears representing a variety of disease states.  Review with knowledge of subsequent development of carcinoma biases the objectivity of the review and does not reflect standard practice.
4. 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, the courts should look to whether the overall practices of the laboratory meet the standard of care.
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 upon the expert physician-witnesses that have, at a minimum, the following qualifications:
   
   
• Maintain a current and unrestricted license to practice medicine in his/her state of practice;
  
  
• Certified by the appropriate ABMS specialty or subspecialty board, and is fully trained in the practice of cytopathology, and
  
  
• Knowledgeable in the practice of cytopathology as indicated by years of practice experience, current up-to-date continuing medical education and active engagement in the practice of cytopathology.
  
  
6. Compensation of the physician-witness should reasonably reflect the time and effort expended by the witness in preparation, deposition and trial.  Compensation of a physician-witness contingent on the outcome of the case introduces the possibility of bias and should not be permitted.
7. The state should adopt a mechanism by which non-binding arbitration would be required prior to filing any civil action alleging negligence in the taking, examining or reviewing of a Pap smear or the reporting of its results.  The non-binding arbitration mechanism should include the following:
   
   
•   The arbitration panel should include individuals trained and having experience in cytopathology;
  
  
• If, after the arbitration recommendations, the plaintiff pursues legal action and recovers less than the amount recommended, the plaintiff should be required to pay all costs of the defendant in connection with the litigation, including attorney fees
  
  
• If the defendant refuses to pay the amount recommended in the arbitration and the plaintiff recovers an amount equal to or greater than the amount recommended, the defendant should be required to pay all costs of the plaintiff in connection with the litigation, including attorney fees; and
  
  
• The cost of arbitration should be borne equally by the plaintiff and defendant unless otherwise determined by the arbitration panel
  
  
8. If the state does not adopt such a plan, the parties should strongly consider mediation or non-binding arbitration by a panel of individuals trained and having experience in cytopathology