Medicolegal affairs. International Academy of Cytology Task
Force summary. Diagnostic Cytology Towards the 21st Century: An International
Expert Conference and Tutorial.
Department of Pathology, Medical College of Virginia, Richmond 23298-0662,
USA.
Abstract
ISSUES:
Increasing litigation over alleged false negative cervical cytologic (CC)
smears threatens the viability of this test for cervical cancer detection.
The problem appears to be largely American but is beginning to appear in
some other countries.
In the vast majority of cases there is either a settlement or jury verdict
for the plaintiff based largely on the testimony of expert witnesses.
Cases are judged on an individual basis without significant consideration
of the general performance of the CC smear in laboratories operating in
compliance with a wide array of laboratory regulations and with documented and
comprehensive quality control practices in place.
It is acknowledged that there are problem laboratories and cytology
practitioners.
There is an emerging issue of automated preparation and screening devices
and issues of informed patient consent.
CONSENSUS POSITION:
Cytology professionals have done an extraordinary and commendable job of
educating the public about the benefits of the CC smear.
We have been less successful and conscientious about explaining and
defining the limitations of the CC test.
There is a need for public and professional education as to the benefits
and limitations of the CC smear for cervical cancer detection.
The process suggested is to work with women's groups, public health
agencies, government agencies, and state and national legislatures and to
coordinate professional committees working on liability issues.
Contextual information could be included with the CC smear report to
indicate that a negative report confers a low probability of developing
cervical cancer.
It is suggested that appropriate language and a menu of statements be
developed.
Increased efforts should be directed to physician education with respect
to informed consent concerning the benefits and limitations of CC smear
testing and the application of new technology to improve smear accuracy.
The process should include development of appropriate statements on the
use of alternative technology.
The profession should develop "process guidelines" for review of CC smears
in the context of possible litigation, including standardized methods for
blind slide review of smears that reduce or eliminate context and outcome
bias.
It is suggested that review panels be anonymous, that the process be
standardized and that there be limitations on liability for participating
organizations.
Professional cytopathology and pathology societies should formulate
acceptable guidelines for expert witnesses.
The standards should be applicable to both defendant and plaintiff
experts.
All materials to the extent practical, including consultant opinions,
should be available for peer review.
Professional cytopathology and pathology societies should monitor expert
testimony for objectivity and scientific accuracy.
ONGOING ISSUES:
For the near future, litigation will continue to focus on false negative
CC smears on a case-by-case basis.
Laboratories and individuals can reduce the risk of malpractice liability
by directing their attention to proactive quality control and quality
assurance methods.
In the final analysis, consumer education about the benefits and
limitations of the test is key to limiting malpractice claims.
To stem the tide of continued medicolegal challenges to the integrity of
cytology practice, the cytology community has now focused its efforts on
developing and utilizing standards that convey to patients, attorneys and
cytologists the contemporary status of and reasonable expectations for the
practice of cytology.
Guidelines such as those for uniform reporting terminology and clinical
management of cervical abnormalities form the basis of cytology practice
standards on which legal standards of practice can be based.
Consensus conference reports, clinical management trials and
scientifically valid studies of false negative rates that analyze the type,
frequency and cause of missed cases represent sounder methods of establishing
defensible