Patient Safety and Quality Improvement Act of 2005

William E. Fassett


The Annals of Pharmacotherapy. 2006;40(5):917-924. 

In This Article

Patient Safety Organizations

PSOs are private or public entities, or components thereof, that apply to the secretary of the DHHS and are listed by AHRQ. PSOs must conduct patient safety activities as defined in PL 109-41, must recertify to the AHRQ every 3 years, and must satisfy the following criteria:

  1. The mission and primary activity of the PSO is to conduct activities that improve patient safety and healthcare delivery quality.

  2. Appropriate staffing, including licensed professionals, is provided.

  3. Within each 24 month period, the entity has bona fide contracts with more than one provider for the purpose of receiving and reviewing PSWP.

  4. The organization collects PSWP to the extent possible in a standardized manner that permits valid comparisons of similar cases among similar providers.

  5. The entity uses PSWP to provide direct feedback to providers to effectively minimize patient risk.

  6. The PSO is not a health insurance issuer or a component thereof.

  7. The PSO (a) fully discloses all financial, reporting, or contractual relationships between itself and contracting providers and (b) specifically indicates to AHRQ any case in which the entity is not managed, controlled, or operated independently from a contracting provider.[33]

PSOs that are a component of another organization (eg, a pharmacy association) must demonstrate that the PSO maintains PSWP separately from the rest of the organization, with appropriate security measures to maintain confidentiality. The PSO must also demonstrate that it does not make unauthorized disclosures of PSWP to the rest of the organization and that the mission of the PSO does not create a conflict of interest with the rest of the organization.

Because PSWP arises only from patient safety activities, it is important to understand which activities fall into this category. Patient safety activities include:

  1. efforts to improve the safety and quality of health-care delivery,

  2. collection and analysis of PSWP,

  3. development and dissemination of information with respect to improving patient safety (eg, recommendations, protocols, or information regarding best practices),

  4. utilization of PSWP to encourage a culture of safety and provision of feedback and assistance to effectively minimize patient risk,

  5. maintenance of procedures to preserve confidentiality of PSWP,

  6. provision of appropriate security measures with respect to PSWP,

  7. utilization of qualified staff,

  8. activities related to the operation of a patient safety evaluation system and to the provision of feedback to participants in a patient safety evaluation system.[34]

PL 109-41 defines a patient safety evaluation system as "the collection, management, or analysis of information for reporting to or by a patient safety organization."[35]

AHRQ can be expected to develop regulations to implement the certification of PSOs in the near future.


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