Errors in cervical smears: minimizing the risk of medicolegal consequences

Cytologists need to critically evaluate their practices and practice settings to ensure that what they do and how they document what they do will withstand both regulatory and legal scrutiny. Any individual involved in cytology as a laboratory owner, operator, director, supervisor, technical or staff employee, independent agent, or customer representative is a potential target of cytology malpractice litigation. All of these individuals must participate in the risk management process. For the laboratory as a corporate entity, business and technical practices, including quality control and quality assurance procedures, must be contemporary, legitimate, and justifiable. Sound scientific evidence and well-subscribed standards of practice supporting an individual's or laboratory's conduct are the best defenses to malpractice claims. For the near future, litigation will continue to focus on false-negative Pap 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. But in the final analysis, consumer education about the benefits and limitations of the Pap test is key to limiting malpractice claims.