Legislation to improve patient safety; create “safe environment”

Legislation designed to help improve patient safety by reducing mistakes in healthcare settings has a good chance of winning final approval by Congress before lawmakers adjourn for the November election. The measure is backed by the American Medical Association (AMA), the American College of Surgeons (ACS), and a coalition of some 130 healthcare specialty organizations, groups and experts. A House-Senate conference committee is preparing to reconcile slightly differing bills approved by the House in March 2003 and finally, by the Senate on July 23.

"We believe it will be good for both physicians and the patients they serve," says Laura I. Thevenot, executive director of the American Society for Therapeutic Radiology and Oncology (ASTRO), after the Senate approved its bill.

The legislation is a response to a 1999 Institute of Medicine (IOM) report, To Err is Human: Building a Safer Health System, which estimated from 44,000 to 98,000 American deaths each year result from preventable medical errors.

The agency urged Congress to pass legislation to extend peer review protections to data related to patient safety and quality improvement that are developed and analyzed by health care organizations for internal use or to share with others solely for the purposes of improving safety and quality.

"Fear of lawsuits silences what should be constructive, life-saving dialogue among health providers," declares Sen. Judd Gregg (R-NH), one of the key sponsors of the senate bill. "Creating an environment where information can be shared will benefit all patients. Getting this bill over the finish line this year will literally save lives."

The bipartisan Patient Safety and Quality Improvement Act was sponsored by Sen. Gregg, Sen. Jim Jeffords (I-VT), Majority Leader Bill Frist (R-TN) and Sen. John Breaux (D-LA), among others. Sen. Edward M. Kennedy (D-MA), ranking Democrat on the Senate Health, Education, Labor and Pensions (HELP) Committee, was a major force in getting the bill through that panel.

The bill will create a system for voluntary reporting of medical errors; establish federal evidentiary privilege and confidentiality pro-tections to promote the reporting of medical errors, produce better procedures, interventions and safety protocols for eliminating errors and improving quality of care; and permit safety data to be shared and dissem-inated nationally so other caregivers can learn from mistakes that have occurred without fear of litigation, Sen. Gregg explains.

The legislation will create a new entity known as Patient Safety Organizations (PSO), which will collect medical error information, examine the data and provide recommend-ations to physicians and other healthcare groups on how to prevent such errors from occurring in the future.

"The goal is to reduce medical errors and improve the quality of care that patients receive," Ms. Thevenot says.

Sen. Jeffords notes that the Patient Safety and Quality Improvement Act encourages health care providers to report errors and "near misses" to PSOs, which would use the data to develop recommendations and promote standards to avoid future mistakes. It also includes protections for patient confidentiality, Jeffords stresses. Data collected by PSOs will be stripped of personal information and forwarded tofederal agencies or other organizations for analyses of nationwide trends.

Including "near misses" is especially important, experts say, because there are far more such incidents than actual errors, and examining circumstances surrounding them 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," Paul M. Schyve, M.D., senior vice president of the Joint Commission on Accreditation of Healthcare Organizations, told AMNews.