Policy Statements
Guidelines for the Review of Pap Tests
in the Context of Litigation or Potential Litigation
Policy Synopsis
Pap smear 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 smear 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.
Policy
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 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%.
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 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.
- 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.
- The standard of care should be that
of the reasonable and prudent practitioner. Focussed
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:
o Maintains a current and unrestricted license to
practice medicine in his/her state of practice;
o Is certified in anatomic pathology by the American
Board of Pathology or by an equivalent Board; and
o 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:
o Maintains a current and unrestricted license to
practice if licensure is required in the state in which
the cytotechnologist practices;
o Is certified as a cytotechnologist by the ASCP board
of Registry; and
o 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.
Policy from the College of American
Pathologists.
Endorsed by the New Jersey Society of Pathologists, 2004
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