Quality and liability issues with the Papanicolaou smear: lessons from the science of error prevention.
The pathologists and cytologists who study Papanicolaou smears perform a highly successful cancer screening test in a low-prevalence population. This leads to a mathematically inevitable false-negative error rate even in the most competent professional hands. The US judicial system supports a public expectation of perfect performance by civil and, recently, criminal punishment of error. Lessons are sought from a considerable industrial experience with accident prevention for possible insights into process improvement that might mitigate the risk of false-negative errors. The elements that, by system analysis, contribute to accidents are reviewed, and the conditions that enhance the accident potential are outlined. The cognitive functions and aberrations that are involved in the operator component of error analysis are described. As a result of pathologists' activities in the systematic measurement of laboratory performance for the last half century, the College of American Pathologists' accreditation program and its derivative Clinical Laboratory Improvement Act requirements have already laid out the avenues of error minimalization. There are no lessons from the science of error prevention that can affect the public expectation of zero error in a screening test and the consequent punishment of cytology professionals. A thesis is offered that the problem is society's if its goal is eradication of cervical cancer mortality. A call is made for leadership by a prestigious, nonpathologist, national organization to make the public understand that the current cytology liability issue is primarily a threat to women and the public health. To initiate public dialogue, a mechanism is suggested to protect simultaneously a patient's right of access to the judicial system and the general availability of the Papanicolaou smear to reduce cervical cancer mortality and morbidity.