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U.S. Stalls on Patient Safety

ASHRM committee chairman reports little progress on implementation of federal law.

By Dan Reynolds

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Voluntary reporting of medical errors, although lauded by healthcare risk managers and industry watchdogs as a panacea for keeping medical-malpractice premiums under control, is still being held captive by a crazy quilt of policies and recommendations, according to one healthcare risk management expert.

Dan Groszkruger, the director of legal services for the Tri-City Medical Center in the Pacific beach town of Oceanside, Calif., and chairman of the American Society for Healthcare Risk Management's Patient Safety Interest Network Task Force, seems just as befuddled as anyone else as to why patient safety laws are stalled in Washington, D.C., though you'd never know it given his diplomatic style.

To begin with, said Groszkruger, there hasn't been any movement on implementation of the Patient Safety and Quality Improvement Act of 2005.

Signed into law by President George W. Bush on July 29, 2005, the act aimed to create a network of patient safety organizations that would collect and disseminate information on medical errors throughout the country, keeping the source of the error confidential.

The act also called for the creation of a network of patient safety databases to act as a national clearinghouse for patient-safety information.

But to hear Groszkruger tell it at ASHRM's annual conference in Chicago last October, the act seems to have become one more victim of politics, or at least bureaucracy.

"It's two years later, have you heard anything?" said Groszkruger, acting about as fired up as he gets, at least publicly.

Despite a recent joint letter from such groups as the American Medical Association and the American Association of Hospitals urging the U.S. Department of Health and Human Services to act on the law, Groszkruger says, it still hasn't been implemented.

"Nobody seems to know where this particular piece of legislation has resided," Groszkruger observed dryly.

Karen Migdail, a spokeswoman for the Agency for Healthcare Research and Quality, the federal agency responsible for implementing the new law, said the new regulations are undergoing extensive review by the executive branch's Office of Management and Budget and the U.S. Department of Health and Human Services.

She said the new regulations should be posted sometime in the spring.

"AHRQ has not ever published a regulation before. This is a new experience for us," Migdail said.

A representative of a nonprofit that should be affected by the new regulations said he is waiting patiently.

"They did do an adequate job of stakeholder consultation," said Bill Marella, director of patient safety programs for the ECRI Institute, a nonprofit based in Plymouth Meeting, Pa., which researches such patient safety issues as medical errors.

Marella said his organization and others were able to provide input into the regulation drafting process.

On the state level, there has been some progress on the topic of voluntary reporting of medical errors, Groszkruger said.

But contrary to the advice of many healthcare risk managers interviewed by Risk & Insurance® in September, very few states actually mandate that healthcare providers inform the patient when they make a mistake.

Despite the effectiveness of a simple apology or an early settlement offer, states still seem to be unclear on the concept of revealing to the patient that they've been the victim of a medical mistake.

Although New Jersey, Connecticut, Minnesota, Indiana, Washington, California, Vermont and Illinois have laws requiring reporting of medical errors, only New Jersey, California and Connecticut require that the patient be informed of the error.

"Isn't that interesting?" Groszkruger deadpanned.

January 1, 2008

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