Patient Safety Organizations are mandated to look for trends and feed patient safety data back to the healthcare community

April 14, 2008

The federal government is creating independnet reporting agencies to collect data about medical errors. AHRQ is seekng public comment on proposed rules.

To improve patient safety, the federal government is creating independent reporting agencies that will collect and disseminate data about medical errors, including medication errors, while protecting the privacy and potential liability of the professionals reporting them. Named patient safety organizations (PSOs), the Agency for Healthcare Research and Quality (AHRQ) is seeking comments on proposed rules for their implementation, which is anticipated sometime early next year.

Proposed rules have been published in the February 12 Federal Register and AHRQ is seeking public comment. "What Congress is seeking is to create federal-level agencies guaranteeing that what you say cannot be used against you," said Kasey Thompson, Pharm.D., director of practice standards and quality for the American Society of Health-System Pharmacists. "It remains unclear exactly how that will be done."

The design and scope of the PSOs are indeed in flux, but their purpose is clear: They are mandated under the Patient Safety and Quality Improvement Act of 2005 to look for trends and feed patient safety data back to the healthcare community. Under that law, public and private entities, for-profit or nonprofit, can seek listing with AHRQ as a PSO.

The law prohibits insurers from becoming PSOs, however, and the current Notice of Proposed Rulemaking (NPRM) prohibits public and private entities with regulatory authority over providers, such as accreditation and licensure bodies, from becoming these bodies.

Existing organizations that collect safety data are eligible.

Hospitals can create own PSOs

"What the PSOs offer is stability on the issue of confidentiality," said Thompson. "They codify that people reporting information to these agencies are protected from liability on the act of reporting." Health systems also can create their own PSOs, or can participate with other entities in creating a PSO. It's unclear at this point whether there will be many hospitals interested in setting up their own PSOs.

No federal funds are available for creating the entities. The PSOs must be designed not to conflict with any existing state agencies, and medical records used in the collection and dissemination of safety data will be protected under current privacy laws, including the Health Insurance Portability and Accountability Act of 1996.

Beyond these basic specifics, how PSOs will function-their governance, reporting obligations and standards, regulatory limitations, and their liability (if any)-remains unclear. When questioned about what healthcare organizations can do at this point to ready themselves to deal with PSOs, Clancy replied, "Nothing at this point, not until the rules have been finalized."

Need your comments

AHRQ is currently seeking public comment on the NPRM until April 14. Information on how to comment on the NPRM, the goals of the legislation, an audio transcript, the rulemaking process, and answers to frequently asked questions, can be accessed at http://www.pso.ahrq.gov/.

THE AUTHOR is a writer based in Gettysburg, Pa.