What a Patient Safety Organization is
A Patient Safety Organization is an entity listed by the Secretary of Health and Human Services, through AHRQ, under a 2005 federal statute built on a single observation: people do not report what they expect to be punished for.
The statute
On July 29, 2005 the President signed the Patient Safety and Quality Improvement Act of 2005 — the Patient Safety Act, 42 U.S.C. §§ 299b-21 to 299b-26 — into law. AHRQ describes what it did: it amended Title IX of the Public Health Service Act “to provide for the improvement of patient safety and to reduce the incidence of events that adversely affect patient safety by authorizing the creation of patient safety organizations.” AHRQ describes what PSOs do in one line: they “work with providers to improve quality and safety through the collection and analysis of aggregated, confidential data on patient safety events.”
The implementing regulation is the Patient Safety Rule, 42 C.F.R. Part 3.
What listing is
Listing means an entity certified to AHRQ that it meets the statutory criteria, and AHRQ accepted the certification. Listings run for three years and must be renewed. A listed PSO carries ongoing obligations — including a requirement under the Patient Safety Rule to hold two bona fide contracts in each successive 24-month period, and a duty to notify the Secretary promptly if it can no longer comply with any of its attestations or if the information it submitted stops being accurate.
What listing is not
- It is not a license to regulate anything. A PSO has no authority over any provider.
- It is not an accreditation body. A PSO does not accredit or license providers — and an entity that does accredit or license providers is asked to say so on the listing form.
- It is not an endorsement of a provider. Listing describes the PSO, not anyone the PSO works with.
- It is not government employment. A listed PSO is a private entity.
- It is not a Medicare or CMS designation. Medicare does not list PSOs.
The confidentiality mechanism
The reason the statute exists is patient safety work product: information developed for reporting to a PSO can carry federal confidentiality and privilege protections, so that a provider analyzing its own failures is not building the case against itself. Patient safety work product.
The “Listed PSO” logo
AHRQ permits currently listed PSOs to display a “Listed PSO” logo, restricted to information about the PSO itself — a listed PSO’s own website, for example, and not the websites of its parent or affiliated organizations. A PSO that ceases to be listed is expected to remove it promptly.
Further reading: What a Patient Safety Organization actually is · CareGuard’s listing, P0268.