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A report from ECRI, the nonprofit health care device analyst in Plymouth Meeting, PA, underscores the point that Papnet automated screening leaves many questions unanswered from a risk management perspective.1 This well-respected research organization notes that automated screens can’t solve all the problems associated with Pap smears, and are not a mandatory part of any cancer screening program.
In addition to questions about the overall technical efficacy of automated screens, ECRI addresses some thorny legal issues that occur when clinicians consider adopting new technology. In the case of automated Pap smear screening, ECRI says there may be a dilemma when pathologists inform referring clinicians of the availability of automated screening.
"Predictably clinicians, upon receiving such information from the pathologist, might be concerned about their own risk of liability should they fail to inform the patient," ECRI writes. "Pathologists . . . must weigh this potentially negative influence on the referral relationship against the potentially positive influence on liability exposure. Although it is unclear whether clinicians (mainly gynecologists and family practitioners) have a duty to inform patients of the newly available technologies, some attorneys have suggested that clinicians’ legal exposure is unlikely to be altered by pathologists’ actions in this regard."
ECRI suggests that the liability risks associated with Pap smears could be significantly reduced by paying close attention to the manner Pap smear slides are handled within facilities. Exposure can be increased if the slides are lost or damaged in transit, making them unsuitable for screening or rescreening.
ECRI suggests these steps to reduce risk and other legal problems:
• Ensure that your staff has specific protocol for packaging and shipping slides to prevent breakage. Document custody of the slides while en route. Discourage patients from transporting their own slides; if they insist, document that you have transferred responsibility for the slides’ safekeeping to the patients.
• Remind pathologists, technicians, pathology residents, and other lab workers to seek advice from your risk management department before sending slides that are requested for legal reasons. Since it is usually extremely difficult to get the slides back once they have been released to someone else, you might not want staff to automatically send them out when requested. You may decide to contest a subpoena or require investigators to view the slides on your premises, for instance. At a minimum, you should require that party be responsible for any damage or spoliation of evidence.
• Educate staff about the difference between altering original reports and filing an amended ones once new evidence is in hand. An amended report to an original Pap smear may be appropriate after a slide is rescreened, but the first report should never be altered. Instruct staff to contact the risk manager if the amended report was prompted by legal action or medical review that is subject to legal action.
1. ECRI. Pap smears. Healthcare Risk Control 1998; March:1-23.