Warming the Chilling Effect

Patient safety law seeks to uncover the skeletons in the closet.

It has been five years since the Institute of Medicine published “To Err is Human,” a report in which experts estimated that as many as 98,000 people die every year from medical errors that occur in hospitals. Now, with the signing of the Patient Safety and Quality Improvement Act of 2005, the government has given providers a tool to help them address the problem.

The law establishes a confidential reporting structure in which physicians, hospitals and other healthcare professionals and entities can voluntarily report information on errors to so-called Patient Safety Organizations (PSOs). The PSOs, in turn, will analyze the data to develop strategies to improve patient safety. Reports submitted to the PSOs will be confidential and legally protected. In fact, penalties will be applied to those who unlawfully disclose them.

The PSOs will report non-identifiable incidents and reports to a network of databases facilitated by the Department of Health and Human Services. This is intended to preserve the confidentiality of patient information under the Health Insurance Portability and Accountability Act of 1996.

The law does not interfere with patients’ rights to file malpractice lawsuits, nor does it shield information available outside of a patient safety evaluation system, such as medical and billing records. What’s more, providers are still required to report device failures and other adverse events, as currently required by law.

‘Common sense’
When he signed the bill into law on July 29, President Bush called it a “common-sense” step. “To maintain the highest standards of care, doctors and nurses must be able to exchange information about problems and solutions,” he said. “Yet in recent years, many doctors have grown afraid to discuss their practices because they worry that the information they provide will be used against them in a lawsuit.

“This bill will help solve that problem. This is a common-sense law that gives legal protections to health professionals who report their practices to patient safety organizations. By providing critical information about medical procedures, doctors and nurses can help others learn from their experiences.”

Indeed, the Patient Safety Act had been supported by a number of professional associations, including the American Hospital Association, the American Medical Association, and virtually every specialty society and state medical society in the country, including the American Academy of Pediatrics, American Academy of Family Physicians, American College of Cardiology, American College of Surgeons and American College of Obstetricians and Gynecologists.

Unanswered questions
At press time, many details had yet to be ironed out, including the exact nature of the patient safety organizations. The Agency for Healthcare Research and Quality, part of the Department of Health and Human Services, appears to hold primary responsibility for certifying PSOs, following criteria laid out in the law itself. But that criteria is pretty loose.

“The legislation doesn’t stipulate a lot, other than [PSOs] cannot be insurance companies or components of one,” says William Munier, M.D., acting director of the Center of Quality Improvement and Patient Safety for AHRQ. “They also have to have contracts with providers, which presumably means that hospitals themselves cannot be PSOs.” At least one state has already set up a PSO.

Another detail that remains to be ironed out is the exact form in which providers will provide reports to PSOs. “The law allows the [HHS] Secretary to provide technical assistance on the type of reporting,” says Munier. “It requires our agency Ð in a report we’re now required to report every year Ð to incorporate [information] from the PSOs. By implication, that suggests that if we don’t provide technical assistance in the form of uniform definitions, we will not be able to provide that annual report. In addition, the law calls for the PSOs to transfer information among themselves. That would be useful, so they can learn from each other. But they won’t be able to do that unless they use common definitions.”

Another huge question is where the funding for the program will come from. On that point, the law is silent.

Part of a larger picture
The Patient Safety Act augments some activities already being undertaken by the Agency for Healthcare Research and Quality, says Munier. For example, the agency produces a report on healthcare quality. “Adding reporting on a national basis on events that are causing harm to patients is a natural add-on to what we’re doing now.”

And the agency has a model to follow, says Munier. That would be the U.S. Department of Veterans Affairs, which has a well-oiled reporting system already in place.

Indeed, public reporting on healthcare quality is in the air. In early April, the Hospital Quality Alliance Ð a coalition of hospital organizations and federal agencies Ð launched www.HospitalCompare.hhs.gov, designed to help patients and families determine to what extent certain hospitals are following agreed-upon quality measures. (An example: What percent of heart attack patients are given thrombolytic medication within 30 minutes of arrival?) More than 4,200 acute care hospitals have agreed to provide data publicly on an initial set of 17 quality measures.

Hospital Compare is intended to be a starting point, with more information and easier-to-use displays to be made available in the near future. Researchers and clinicians also can use this information to identify organizations with stellar performance so that they can learn from these outstanding practices.

Systems like the one established by the Patient Safety Act are long overdue, says Munier. “While individuals are sometimes responsible for things that go wrong, at the same time, it’s the malfunction of the system as a whole Ð when different pieces of an organization come together Ð that cause failures not easily attributed to one person. But the culture of blame and malpractice exerts a chilling effect on people’s willingness to report [problems]. So the law sets up an exemption, so that reporting is held in confidence.”

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