The U.S. Department of Health and Human Services has released a new interim guidance that addresses 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. PSOs are organizations that can work with clinicians and health care organizations to identify, analyze, and reduce the risks and hazards associated with patient care with a secure environment through the strong Federal confidentiality and privilege protections for information developed. The intention of the PSA is to accelerate speed with which solutions can be identified for the risks and hazards associated with patient care.

Organizations eligible to become PSOs include public or private entities, profit or not-for-profit entities, provider entities such as hospital chains, and other entities that establish special components to serve as PSOs.

The interim guidance allows HHS's 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 guidance states in part, "The basic certifications applicable to all PSOs require assurances as to expertise, capacity and purpose to carry out the patient safety activities defined in the Patient Safety Act. The definition of patient safety activities includes maintenance of confidentiality procedures and provision of appropriate security measures." The Web site includes further explanation of the certification process and instructions for submitting this form either electronically or via mail. After the organization's certifications are accepted, AHRQ will list the entity as a PSO on the AHRQ PSO Web site.

According to the HHS's PSO website, "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.

Adapted from a press release from HHS.

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