HHS Releases Interim Guidance for Patient Safety Organizations

The U.S. Department of Health and Human Services has released new interim guidance that outlines how to become a Patient Safety Organization (PSO).

The Patient Safety and Quality Improvement Act (Patient Safety Act) authorized the creation of PSOs to improve safety through the collection and analysis of data on patient safety events. By providing both privilege and confidentiality, PSOs will create a secure environment where clinicians and health care organizations can voluntarily collect, aggregate and analyze data that enable the identification and reduction of the risks and hazards associated with patient care.

The interim guidance allows HHS' Agency for Healthcare Research and Quality to begin receiving applications from qualified entities that wish to become PSOs. This guidance will remain effective until HHS issues a final rule for PSOs, which will then supersede the interim guidance. A final rule is expected to be released by the end of 2008.

"We know that clinicians and health care organizations are anxious to begin these important new patient safety improvement efforts under the Patient Safety Act," said AHRQ Director Carolyn M. Clancy, M.D. "As we move expeditiously toward a final rule, this interim guidance will help organizations interested in applying now to become Patient Safety Organizations to undertake work that will improve the quality of America's health care."

The interim guidance describes how an organization may become a PSO by submitting a certification form that is available on AHRQ's PSO Web site. The Web site includes more explanation of the certification process and instructions for submitting this form either electronically or via mail. When the organization's certifications are accepted, AHRQ will list the entity as a PSO on the AHRQ PSO Web site.

"Patient safety work product," which is the data submitted by the health care provider to a listed PSO and the data developed by the listed PSO during the interim guidance period, is privileged and confidential under the Patient Safety Act. This patient safety work product will remain privileged and confidential during and after the interim period. HHS' Office for Civil Rights will enforce the confidentiality provisions of the Patient Safety Act. These data protection provisions are a significant component of the Patient Safety Act.

To facilitate the collection and reporting of patient safety information, AHRQ released Common Formats on Aug. 29. The Common Formats, now available for download through AHRQ's PSO Web site, provide common definitions and reporting formats that health care professionals can use to collect and track patient safety information. These formats may be used by providers and PSOs to report a range of patient safety concerns, capturing both structured and narrative information.

For more information on PSOs, to access the interim guidance or to read the notice of proposed rulemaking, visit http://www.pso.ahrq.gov.

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