Liability Jitters May Impede Patient Safety System


WASHINGTON — The patient safety system signed into law this summer by President Bush will likely take many months to implement—and is likely to demand some adjustment in physician attitudes about error reporting.

Under the new law, a “patient safety work product” of reported errors and near misses is privileged and cannot be used in legal or disciplinary actions. Data collected can be used in a criminal trial only after the court makes a determination that the evidence is “material to the proceeding” and “not reasonably available from another source,” according to text of the Patient Safety and Quality Improvement Act of 2005.

The structure will allow providers to voluntarily submit information to patient safety organizations certified by the Department of Health and Human Services. Patient confidentiality must be maintained. The purpose of the system is to create a searchable database of medical errors that can be analyzed and used to develop new care systems and best practices that would avoid similar errors in the future.

The law authorizes federal funding for fiscal years 2006–2010. Implementation could begin as early as next year, said Gordon Wheeler, associate executive director for public affairs for the American College of Emergency Physicians, noting that for that to happen, the HHS “secretary's got a lot to do to set it up.”

HHS must coordinate databases nationwide into a single aggregated interactive resource for providers and patient safety organizations. It also must develop or adopt voluntary national standards to promote the electronic exchange of health care information.

HHS will also certify the organizations, which were described as “new animals,” by Margaret VanAmringe, vice president for public policy and government relations at the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

There are several possible models for patient safety organizations, she said, including U.S. Pharmacopeia's MEDMARX system. For a subscription fee, hospitals and health care systems can access MEDMARX's database to track adverse drug reactions and medication errors. Ms. VanAmringe also said groups like JCAHO could develop patient safety organizations, as could medical specialty organizations looking to establish “niche PSOs” to track specific areas, such as anesthesiology.

For physicians, who have operated so long in an environment of liability fear, it may take a while to trust the new system, said Michael O. Fleming, M.D., board chair of the American Academy of Family Physicians.

“Physicians are going to have to get comfortable with this and realize that [documenting errors under the plan] is a thing that you can do now, and it's going to improve quality tremendously,” said Dr. Fleming, adding that it may take physicians some time to lose their reporting inhibitions.

Doctors are concerned about reporting something going wrong, because someone will be at fault and liable for that situation, he said. “In medicine, unfortunately, too many times everybody—from staff to nurses to doctors—has been afraid to report things.”

Dr. Fleming said the arrangement could help reveal weaknesses in medication dispensing and other systems. “This will give us an opportunity, when these errors occur, to report them without having to worry about the consequences of a liability threat,” he noted.

Many patient safety organizations will likely be run by systems analysts and industrial engineers, “I'm hoping there are also going to be peers,” Dr. Fleming said. “I think physicians are going to feel much more comfortable if we have peer evaluation.”

Ms. VanAmringe said patient safety organizations will not only need to collect data but also have the ability to aggregate and analyze those data to provide institutions with “feedback on common problems.” The PSOs will develop solutions and best practices by collating data from different institutions and then monitoring whether proposed interventions work.

“PSOs will play a fairly robust role in using the data that are reported to them,” she said.

Federal PSOs will not preempt state laws, even those with mandatory reporting systems, but VanAmringe said many state arrangements are more narrowly focused and do not provide the data analysis expected from federal PSOs. The federal program will provide standardized reporting methods and more in-depth, comprehensive analysis and potentially will develop more solutions to common problems, she said.

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