Senate passes patient safety bill with new error reporting system

Washington A national system for collecting medical error data seems closer to reality than ever before.

On July 22, the Senate passed its version of patient safety legislation, which will now have to be reconciled with the House measure approved in March of last year. The legislation's proponents have high hopes that a final agreement can be hammered out and passed by Congress this year.

The bill has bipartisan support from powerful members of each party, including Senate Majority Leader Bill Frist, MD (R, Tenn.), and Sens. Edward Kennedy (D, Mass.) and Judd Gregg (R, N.H.).

"You have all these people saying we have to pass it," said Donald J. Palmisano, MD, immediate past president of the American Medical Association, which has been part of a large coalition urging passage. "The support was bipartisan, and it was a win for patients and physicians."

While differing in details, the Senate measure is similar to the House bill in that they both would authorize creation of patient safety organizations and establish a set of criteria by which they could be credentialed. These groups would be responsible for collecting and collating data on medical errors, as well as producing reports to help institutions and physicians' practices correct systematic problems that lead to those errors.

"The bill eliminates the shame-and-blame mentality and encourages voluntary, confidential reporting for review by experts and feedback so that the systems can be changed where the errors occurred," said Dr. Palmisano. "The lessons learned can be shared in a de-identified fashion so that everyone benefits."

Data collected by the patient safety organizations could be stripped of personal information and sent on to federal agencies or other organizations for analyses of nationwide trends.

It's important that patient safety organizations demonstrate a benefit from the information they collect, said Henri R. Manasse Jr., PhD, executive vice president and CEO of the American Society of Health System Pharmacists.

Error reporting systems also have the potential to change the tone in the medical liability system, he said.

Naturally, if reporting leads to fewer errors, that will reduce the number of lawsuits against physicians, Dr. Palmisano said.

Voluntary and confidential

While the legislation does not make error reporting mandatory, physicians and hospitals would have little to lose from submitting reports to these groups because the documents would be kept confidential.

But reporting error data to a patient safety organization would not protect the original information from use in a lawsuit.

"Anyone who wants to make a claim against a physician or a hospital or a nurse still has available all the usual means for discovery of information," Dr. Palmisano said.

Currently, six states and several national groups already have some experience with error reporting, but the federal legislation would create a different system in distinct ways.

For example, states with patient safety laws mandate that hospitals and other medical institutions report errors that lead to serious patient injuries. Many states also make this information public. Reporting laws passed more recently in some states are mandatory but confidential.

Experts seem to agree that a voluntary system combined with strict confidentiality of the information is the best way to encourage people to report their mistakes.

Simply put, mandatory is not necessarily mandatory if people are afraid to report information that can later be used against them, said Paul M. Schyve, MD, senior vice president of the Joint Commission on Accreditation of Healthcare Organizations.

"Because of the fear of disclosure that might then come back and hurt them, organizations have been very hesitant to report this kind of information, what goes wrong and why," he said. "The absence of this kind of protection actually has slowed our country's ability to make advances in the area of patient safety."

Although the federal reporting requirement would be voluntary, the legislation does not call for preempting state laws, meaning reporting of some events would still be mandatory in states with required disclosure.

More data to mine

The state reporting systems also differ from the federal proposal in that they collect information on only egregious errors -- what have become known as "never events," shorthand for the contention that they never should have happened.

The federal legislation calls for collecting a much larger pool of data on minor errors and near misses that potentially could uncover a multitude of systematic problems.

"Near misses, with just a little extra push here or there, could have become one of these serious events and, as a result, you can learn from the near misses," Dr. Schyve said. "Because near misses are much more common than the actual bad event, you may actually have more data to learn from when you're collecting the near misses."

Developing the local and national infrastructure needed to collect these new data and turn them into useful information for physicians and others will be a complex task. The patient safety organizations will have to adhere to relatively strict credentialing requirements but still could take many different forms, experts said.

While the groups might work on a regional basis to collect information from local institutions, they also could work nationally, concentrating on specific types of errors such as prescribing or surgical mistakes.

Above these regional or specialty organizations, national groups could use the de-identified data to create virtual databases that paint a bigger picture of trends in medical errors.

The enormous potential for finding new and effective ways to reduce medical errors is one of the reasons many people in the medical community are so enthusiastic about passage of this legislation.

"It's a monumental accomplishment, and it opens the door to rapid advancement in patient safety akin to the successful model of the aviation reporting system," Dr. Palmisano said.