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New Patient Safety Proposed Regulation Aims to Improve Health Care Quality and Patient Safety

ROCKVILLE, Md., Feb. 12 /PRNewswire-USNewswire/ -- 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 today 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.

"Patient Safety Organizations will help make health care safer for all Americans," HHS Secretary Mike Leavitt said. "By making it easier for patient safety events to be reported and the lessons learned from them to be shared more broadly, patients will ultimately receive safer health care."

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.

HHS' 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.

"We know that clinicians and health care organizations want to participate in efforts to improve patient care, but they often are inhibited by fears of liability and sanctions," said AHRQ Director Carolyn M. Clancy, M.D. "The proposed regulation provides a framework for Patient Safety Organizations to facilitate a shared-learning approach that supports effective interventions that reduce risk of harm to patients. We want to make the right thing to do the easy thing to do."

Winston Wilkinson, director of OCR, added: "It is essential to the success of this new voluntary reporting program that the information exchanged to address important patient safety issues remains privileged and confidential. Provider trust in our enforcement of strong confidential protections will encourage participation in the critical work of improving the understanding of the threats to patient safety and ultimately improving care for all patients."

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.

Members of the public are invited to comment on the proposed regulation until April 14, and their feedback will be used to shape the final regulation. In addition, AHRQ and OCR are planning to host an audio conference on Feb. 29 from 2:00 p.m. to 3:00 p.m. EST, to provide additional details and answer questions about the proposed regulation. More information on the audio conference can be found at

The notice of proposed rulemaking was published in today's Federal Register. The proposed regulation can be viewed on the Federal eRulemaking Portal at e8&disposition=attachment&contentType=html. The Federal Register notice can also be accessed via AHRQ's Web site at

Comments can be submitted by any of the following methods:

Federal eRulemaking Portal: 9000064803acce8

Comments should include the agency name (AHRQ and/or OCR) and "RIN 0919-AA01."

Mail/hand delivery/courier: Center for Quality Improvement and Patient Safety, Attention: Patient Safety Act NPRM Comments, AHRQ, 540 Gaither Road, Rockville, Md. 20850.

Comments sent by facsimile (FAX) transmission or electronic mail will not be accepted.

Comments received through the eRulemaking Portal can be viewed online at either of the Web sites listed above. All comments received through the eRulemaking Portal, mail, and hand delivery/courier are available for public inspection at the AHRQ Information Resources Center, which is located at 540 Gaither Road, Rockville, Md. 20850. The Information Resources Center is open from 8:30 a.m. to 5:00 p.m. EST, Monday through Friday.

Note: All HHS press releases, fact sheets and other press materials are available at

SOURCE U.S. Department of Health and Human Services
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