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New Regulation Proposed to Establish Patient Safety Organizations

In February, the U.S. Department of Health and Human Services (HHS) announced a proposed regulation to establish Patient Safety Organizations (PSOs) aimed to improve the safety and quality of health care for Americans.

Under the proposed regulation, public and private not-for-profit organizations would be eligible for certification as PSOs — by the HHS Agency for Healthcare Research and Quality (AHRQ) — to gather and analyze information on adverse events arising from health care.

“PSOs can be existing organizations, components of existing organizations, or new entities,” said William B. Munier, MD, director of the Center for Quality Improvement and Patient Safety at the AHRQ. “For example, a hospital chain might want to form a PSO and enlist its members as participating providers. Similarly, a medical specialty society might want to become a PSO and focus on adverse events particular to its specialty.”

The new regulation allows PSOs to create a network of patient safety databases to analyze confidential reports of medical errors or near-errors, the results of which can be searched. The network is currently under development with AHRQ support, said Dr. Munier, and PSOs will be asked to follow common formats and definitions when reporting data to the network.

The AHRQ expects to have an early version of the formats ready in July or August of this year.

As PSOs receive information about multiple hospitals and physicians, they will be able to detect patterns of efficient and problematic practices, Dr. Munier said. They can then offer recommendations to local providers about best practice scenarios and better care delivery, and promote collaboration among providers.

Physicians are often reluctant to participate in quality review activities for fear of legal liability and professional sanctions. The new regulation addresses this fear by making reporting of events privileged and confidential.

The Patient Safety and Quality Improvement Act and the proposed regulations do not set up reporting requirements — the entire initiative is voluntary. PSOs do not replace or obviate compliance with state or FDA reporting requirements.

The AHRQ will publish national and regional statistics on trends from the network of databases in its annual National Healthcare Quality Report.

Sarah Tonn, senior manager of quality improvement at the AAN, where she is also the staff liaison for the AAN Patient Safety Subcommittee, noted that the Academy subcommittee is considering the proposal, and will be presenting its recommendations to the AAN Practice Committee and the Board of Trustees.

Ellis R. Diamond, MD, co-chair of the Patient Safety Subcommittee, said that the new plan would require that the data be supplied and gathered consistently. He noted that protection from litigation will be essential to enable physicians to feel “safe” in adapting their treatment approach from best case scenario recommendations from the PSO data.

“The bottom line,” he said, “is that the more we can connect the data points from care delivery across the nation, the better any individual neurologist can assess what is most appropriate for their patient care ‘tool kit.’”