Information Regarding Interim Guidance

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Information Regarding Interim Guidance

NOTE: The Department of Health and Human Services (HHS) issued a final rule (PDF file, 450 KB; PDF Help) to implement the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) on November 21, 2008. The final rule will become effective on January 19, 2009; on that date, the final rule will supersede the Interim Guidance, which will no longer be effective.

The Patient Safety and Quality Improvement Act of 2005

The Department of Health and Human Services (HHS) is in the process of developing a final rule to implement the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). Because of strong interest within the health care community, HHS has decided to begin the process of listing Patient Safety Organizations (PSOs) and implementing the protections of the Patient Safety Act prior to the promulgation of the final rule.

HHS has developed Interim Guidance that outlines the statutory requirements and relevant sections of the proposed rule (issued on February 12, 2008) that are binding during the interim period. The Notice of the Availability of the Interim Guidance was announced in the Federal Register on October 14, 2008. For more information on the Interim Guidance, please see the press release "HHS Issues Interim Guidance For Patient Safety Organizations".

We have provided forms that entities must use prior to publication of the final rule, both in seeking listing as a PSO and once they are listed. Any entity that is interested in seeking listing as a PSO is strongly encouraged to review carefully the Interim Guidance.

Can My Organization Seek Listing as a PSO?

In general, any public or private, for-profit or not-for-profit entity—or a component of any entity—may seek listing to become a PSO. However, the Patient Safety Act imposes two criteria for entities seeking listing as PSOs:

The mission and primary activity of the entity (or component) must be to conduct activities to improve patient safety and the quality of health care delivery (section 924(b)(1)(A) of the Public Health Service Act, reprinted in Appendix A of the Interim Guidance); and
A health insurance issuer or a component of a health insurance issuer may not become a PSO (section 924(b)(1)(D) of the Public Health Service Act).

Primary activity requirement. Entities submitting certifications for initial listing need to consider carefully whether they meet the statutory requirement that both their mission and their primary activity are to conduct activities to improve patient safety and the quality of health care delivery. A multipurpose entity can create or designate a component that more clearly meets the mission and primary activity criterion; that component can then seek listing. The additional requirements that a component PSO must meet are outlined in section 924(b)(2) of the Public Health Service Act, which may be found at 42 U.S.C. 299b-24(b)(2).

Health insurance issuer exclusion. The statute references a definition of health insurance issuer that includes an insurance company, insurance service, or insurance organization (including a health maintenance organization, as defined in 42 U.S.C. 300gg-91(b)(3)) that is licensed to engage in the business of insurance in a State and that is subject to State law which regulates insurance (within the meaning of 29 U.S.C. 1144(b)(2)). These organizations and components of these organizations may not be listed as a PSO.

For details on how to apply, select How to become a Patient Safety Organization.