House passes patient safety bill; voluntary reporting key

The legislation would create a confidential medical error tracking system that is attractive to physicians and patients.

By Joel B. Finkelstein, AMNews staff. April 7, 2003.

Washington -- Patient safety legislation passed by the House promises to allow physicians to report medical errors without risking being punished based on the information they provide.

The Patient Safety and Quality Improvement Act contains several provisions designed to create a national error-reporting system to collect, assess and recommend changes to avoid future errors. Reporting would be voluntary under the legislation.

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Information generated by this voluntary reporting would be considered confidential and would not be used to bring legal actions against doctors or hospitals. The bill also would prohibit the use of the information as evidence in civil or administrative proceedings or for accreditation purposes.

"Research on patient safety unequivocally calls for a learning environment, where providers will feel safe to report health care errors, in order to improve patient safety," the bill's authors stated. They also noted that the Institute of Medicine report on medical errors recommended a voluntary system because it would be more conducive to learning.

Rep. Mike Bilirakis (R, Fla.), the bill's main sponsor, said it would allow the medical community to "examine the underlying causes of medical errors, current practices and potential solutions."

The measure gained momentum recently because of publicity surrounding the tragic organ transplant error at North Carolina's Duke University, and because it is being viewed as a companion piece to liability reform legislation making its way through Congress.

The Bush administration supports the bill, as do many medical groups.

Health and Human Services Secretary Tommy Thompson said that "by creating a system that will encourage physicians and providers to freely share information about adverse events, this bill will enable us to develop and implement new procedures and techniques to protect patients and prevent correctable errors."

American Medical Association President Yank D. Coble Jr., MD, praised the bill for allowing physicians to report errors confidentially.

"This provides the health care community an opportunity to work together to identify and solve systemwide errors," he said.

Keeping it voluntary

The authors of the legislation had much guidance to follow in devising their approach to patient safety.

Comprehensive and authoritative reports on medical errors have been produced by panels from such organizations as the IOM, the National Quality Forum and the National Patient Safety Foundation.

Those bodies have suggested that voluntary reporting is the way to go.

The medical community has a certain inertia to overcome, said Henry Manassee Jr., PhD, ScD, an NPSF board member and CEO of the American Society of Health-System Pharmacists. There is resistance among doctors to standardized practices, which some call "cookbook medicine."

Although a voluntary system lacks the weight of negative consequences, patient safety is a high priority for physicians, and this would ensure relatively good compliance, Dr. Manassee said. This is even more true for errors that result in death or permanent harm to patients, he added.

Historically, mandatory reporting has not served as a very good motivator. Despite federal requirements for pharmaceutical companies to disclose adverse drug reactions, only about 10% of these events get reported.

The bill attempts to make the confidentiality of reported information explicit. To be effective, the final legislation must make this clear to physicians, Dr. Manassee said.

Beyond reporting

Successful reporting of medical errors is only half the job. The legislation also would charge the Dept. of Health and Human Services with analyzing the information and disseminating the findings to the medical community.

Rapid turnaround time will be crucial if this function is to prove useful, Dr. Manassee said.

This reporting mechanism is envisioned as a federal database administered by HHS in coordination with states and certified patient safety organizations. Working with the states is important because 20 of them already have some mandatory reporting requirements, usually for errors leading to the death of a patient.

The measure does not require the rest of the states to adopt similar mandatory reporting systems, thus falling short of IOM's recommendations, said Janet M. Corrigan, PhD, director of the Institute's Board on Health Care Services.

The bill also calls for physicians, hospitals and pharmacies to implement technology strategies for improving patient safety and reducing errors.

The medical community has failed to take advantage of technological advances that have helped other industries, such as airlines and supermarkets, become more efficient and foolproof, Dr. Manassee said.

To encourage this approach, the bill would require HHS to offer grants to help physicians and other health care players establish electronic prescribing programs. It also calls for grants to hospitals and others for investing in new computer systems geared toward patient safety efforts.

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