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New Patient Safety Proposed Regulation Aims to Improve Health Care Quality and Patient Safety
20 Feb 2008

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 last week 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.  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.” AHRQ will administer the rules for listing qualified PSOs, and the Office for Civil Rights (OCR) is responsible for enforcing the confidentiality provisions of the act.  “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.” 

 

 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. Select for more information on the audio conference.  The notice of proposed rulemaking was published in the February 12 Federal Register.  Select to view the proposed regulation on the Federal eRulemaking Portal.  More information can be found on on AHRQ’s Web site.

 

Source: AHRQ