Feature Story

New patient safety proposed regulation aims to improve health care quality and patient safety

A proposed regulation to improve the quality and safety of health care for all Americans by fostering the establishment of Patient Safety Organizations (PSOs) was announced by the U.S. Department of Health and Human Services (HHS). PSOs are private entities recognized by the Secretary to collect and analyze patient safety events reported by health care providers. They are new and separate from all currently existing entities that are addressing health care quality.

The creation of PSOs has been called for by the Institute of Medicine and would help improve the quality and safety of health care in several key ways. PSOs would allow for the voluntary reporting of patient safety events without fear of new tort liability. In addition, they would encourage clinicians and health care organizations to voluntarily share data on patient safety events more freely and consistently.

Under the proposal, PSOs can collect, aggregate and analyze data and provide feedback to help clinicians and health care organizations improve health care quality. The authority to list, or formally recognize, PSOs was established by the Patient Safety and Quality Improvement Act of 2005.

While the statute makes patient safety event reporting privileged and confidential, it does not relieve clinicians or health care organizations from meeting reporting requirements under Federal, State or local laws. However, the statute and the proposed regulation address an important barrier that currently exists—the fear of legal liability or sanctions that can result from discussing and analyzing patient safety events.

The proposed regulation describes how an organization may become a PSO and explains how clinicians will be able to report patient safety events confidentially, the limited ways in which these data will be shared with others engaging in patient safety work while remaining privileged and confidential, and how clinicians will receive feedback on ways to improve patient safety. Strong confidentiality provisions are the key to voluntary reporting, and breaches of these confidentiality provisions may result in the imposition of civil monetary penalties.

The Agency for Healthcare Research and Quality (AHRQ) will administer the rules for listing qualified PSOs. The HHS Office for Civil Rights (OCR) will be responsible for enforcing the confidentiality provisions of the act.

In addition, the department plans to issue guidance soon that would allow entities to be listed as PSOs, consistent with the statute, prior to publication of the final rule. After collecting and analyzing sufficient non-identifiable data, AHRQ will publish information on national and regional statistics, including trends and patterns of patient safety events. This information will be published in AHRQ's annual National Healthcare Quality Report.

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