Guidelines offer steps for disclosure

New guidelines available from the American Health Lawyers Association (AHLA) codify the many issues to discuss and decisions to make when a healthcare facility is considering disclosure of a serious clinical adverse event (SCAE). The guidance could reduce some of the concerns that can make risk managers and clinicians hesitant to fully disclose errors.

The AHLA guidance describes disclosure of a SCAE as “a multi-faceted process that requires careful planning and coordination by clinical and administrative personnel within the provider organization.” The task force was chaired by Elisabeth Belmont, JD, corporate counsel at MaineHealth, a health system based in Portland, ME.

“In analyzing disclosures of information in connection with SCAEs, there are regulatory and legal considerations to consider regardless of the type of incident,” Belmont says. “Although those considerations may vary according to the particular jurisdiction, this checklist is intended to guide healthcare providers in their analysis and encourage them to be proactive to ensure that their personnel and applicable policies are in alignment on such disclosures prior to the occurrence of a SCAE.” (For excerpts from the guidelines, see below. For additional resources, see p. 90.)

In an era of increasing transparency, disclosure of SCAEs assumes greater importance, Belmont says. Healthcare providers must balance the interests of a patient’s desire for a fully transparent environment with the need to observe the principles of a “just culture” to promote an environment in which clinical personnel are willing to come forward and disclose medical errors in the interests of system safety, she says. (See the story, p. 89, for more on how to implement the guidelines.)

“An inadequate or poorly executed disclosure of a SCAE will serve to frustrate frontline practitioners, negatively affect the reputations of the provider organization and individual practitioners involved in the incident, and encourage medical malpractice claims,” Belmont says. “For this reason, it is important that healthcare providers review their current processes to ensure that regulatory and legal considerations are analyzed prior to the disclosure.”

Investigation and mitigation of the SCAE is a cooperative endeavor involving the affected clinicians, medical staff and nursing leadership, and hospital administration, Belmont says. A risk manager often is the individual tasked with the coordination and investigation of a SCAE, she says. The risk manager needs to work with medical staff and nursing leadership and hospital administration in the investigation of a SCAE and any related disclosures to the patient and his family, state regulatory agencies, accrediting bodies, the media, or other third parties, she says.

“A risk manager should engage these stakeholders in a dialogue to develop a process for the investigation and mitigation of SCAEs,” Belmont says. “At the time of the occurrence of the SCAE, all of the contributing factors may not be apparent. A root cause analysis may take several weeks to complete in the case of a complex therapeutic misadventure, and the results of the analysis may indicate that the cause is a system failure as opposed to the actions of an individual practitioner.” [Healthcare Risk Management sent a special ebulletin about the AHLA guidelines to readers on June 18. If you didn’t receive the bulletin, we don’t have your e-mail address. To receive occasional news ebulletins, please contact customer service at (800) 688-2421 or customerservice@ahcmedia.com.]

Source/Resource

Elisabeth Belmont, JD, corporate counsel at MaineHealth, Portland, ME. Telephone: (207) 661-7010. Email: belmoe@mainehealth.org.

• “Considerations in the Disclosure of Serious Clinical Adverse Events (SCAEs),” published recently by the American Health Lawyers Association, is available at http://tinyurl.com/6wzvbsg.