MEDICOLEGAL AFFAIRS - IAC TASK-FORCE SUMMARY

Increasing litigation over alleged false negative cervical cytologic ( CC) smears threatens the viability of this test for cervical cancer de tection. The problem appears to be largely American but is beginning t o 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 individu al basis without significant consideration of the general performance of the CC smear in laboratories operating in compliance with a wide ar ray of laboratory regulations and with documented and comprehensive qu ality control practices in place. It is acknowledged that there are pr oblem laboratories and cytology practitioners. There is an emerging is sue of automated preparation and screening devices and issues of infor med patient consent. Consensus Position Cytology professionals have do ne an extraordinary and commendable job of educating the public about the benefits of the CC smear. We have been less successful and conscie ntious about explaining and defining the limitations of the CC test. T here is a need for public and professional education as to the benefit s and limitations of the CC smear for cervical cancer detection. The p rocess suggested is to work with women's groups, public health agencie s, government agencies, and state and national legislatures and to coo rdinate professional committees working on liability issues. Contextua l information should be included with the CC smear report to indicate that a negative report confers a low probability of developing cervica l cancer. It is suggested that appropriate language and a menu of stat ements be developed. Increased efforts should be directed to physician education with respect to informed consent concerning the benefits an d limitations of CC smear testing and the application of new technolog y to improve smear accuracy. The process should include development of appropriate statements on the use of alternative technology. The prof ession should develop ''process guidelines'' for review of CC smears i n the context of possible litigation, including standardized methods f or blind slide review of smears that reduce or eliminate context and o utcome bins. It is suggested that review panels be anonymous, that the process be standardized and that there be limitations on liability fo r participating organizations. Professional cytopathology and patholog y societies should formulate acceptable guidelines for expert witnesse s. The standards should be applicable to both defendant and plaintiff experts. All materials to the extent practical, including consultant o pinions, should be available for peer review. Professional cytopatholo gy and pathology societies should monitor expert testimony for objecti vity and scientific accuracy. Ongoing Issues For the near future, liti gation will continue to focus on false negative CC smears on a case-by -case basis. Laboratories and individuals can reduce the risk of malpr actice liability by directing their attention to proactive quality con trol and quality assurance methods. In the final analysis, consumer ed ucation about the benefits and limitations of the test is key to limit ing malpractice claims. To stem the tide of continued medicolegal chal lenges to the integrity of cytology practice, the cytology community h as 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. Guideline s such as those for uniform reporting terminology and clinical managem ent of cervical abnormalities form the basis of cytology practice stan dards on which legal standards of practice can be based. Consensus con ference reports, clinical management trials and scientifically valid s tudies of false negative rates that analyze the type,frequency and cau se of missed cases represent sounder methods of establishing defensibl e practice standards than do anecdotal reports or opinions.