Improvements on patient safety rules

The Patient Safety and Quality Improvement Act of 2005, which was strongly supported by the AMA, is a landmark piece of legislation that creates a positive framework to achieve its stated goal. Now that the measure is inching closer to being put into practice, the AMA is offering some changes that will improve the law's intent.

In February, the Agency for Healthcare Research and Quality published the long-awaited proposed rule that would implement the law. The legislation grew from increasing concerns about patient safety, most notably over news of deadly medical errors published in a 1999 Institute of Medicine report.

The proposed regulations call for creating a federal framework that would allow health care professionals to report medical errors voluntarily to patient safety organizations, without fear of legal prosecution. Confidentiality and legal safeguards are essential to ensure physician participation and encourage voluntary reporting.

Last month, the AMA applauded the AHRQ and reaffirmed that it supports the establishment of a voluntary reporting system. In an April 11 comment letter to AHRQ, American Medical Association Executive Vice President and CEO Michael D. Maves, MD, MBA, wrote that the proposed rule provides additional guidance for creating a patient safety evaluation system that will set the stage for enhancing patient safety activities across health care delivery settings.

The Association noted that the intent of the law is to foster an environment assuring physicians and others that the information they report to patient safety organizations will be used to improve and promote patient safety, not for punitive and regulatory purposes.

But the AMA believes that more safeguards are needed to ensure patient safety and legal protections for physicians. It has urged the AHRQ to adopt a broad definition of "patient safety work product," data reported to or developed by PSOs that could improve health care outcomes.

The AMA also wants the agency to clarify key definitions such as disclosure and recommends that AHRQ adopt reasonable time frames for collecting, developing, analyzing and reporting data to PSOs. The Association agreed with proposed regulations that public and private entities that conduct regulatory oversight of health care, including licensure and accreditation, should be prohibited from being a PSO.

The regulations would allow a component organization of regulatory bodies to become a PSO if firewalls are in place, the AMA said. Component PSOs should be required to identify parent organizations as a regulator and specify the scope of the organization's regulatory authority.

The AMA is working on patient safety initiatives to achieve a successful long-term effort to bolster patient safety in the nation's health care system. AMA Board of Trustees member J. James Rohack, MD, said the proposed rule strikes the appropriate balance between federal oversight and the creation of a voluntary reporting system.

The AMA has vowed to educate doctors about the system, encourage their participation and provide input on establishing the system. With guidance from the AMA and other organizations concerned about patient safety, physicians should have a process by which they feel confident that data about medical errors and near mistakes are used to improve health care quality without worries of prosecution.