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Patient Safety Organization (PSO)

Patient Safety Organization (PSO)


In 1999, the Institute of Medicine (IOM) issued a landmark report entitled, "To Err is Human: Building a Safer Health System," which highlighted critical areas of research and activities needed to improve the safety and quality of health care delivery. One critical area of the IOM report addressed the reporting and analysis of data on adverse events.


The IOM report and its findings spotlighted a serious need to capture information that would help to improve quality and reduce harm to patients. Addressing this need, Congress passed The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). To read the Patient Safety Act, go to


To implement the Patient Safety Act, the Department of Health and Human Services issued the Patient Safety and Quality Improvement final rule. The Patient Safety Act and the Patient Safety Rule authorize the creation of [Patient Safety Organizations] PSOs to improve quality and safety through the collection and analysis of data on patient events.

PSOs are organizations that share the goal of improving the quality and safety of health care delivery. Organizations that are 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. By providing both privilege and confidentiality, PSOs create a secure environment where clinicians and health care organizations can collect, aggregate, and analyze data, thereby improving quality by identifying and reducing the risks and hazards associated with patient care.

Agency Guidance

From U.S. Dep’t of Health & Human Services, Agency for Healthcare Research & Quality, Patient Safety Organizations, (accessed Apr, 21, 2012).

The criteria for selecting an entity as a patient safety organization include:

  1. The mission and primary activity of the entity are to conduct activities that are to improve patient safety and the quality of healthcare delivery
  2. The entity has appropriately qualified staff (whether directly or through contract), including licensed or certified medical professionals
  3. The entity is not, and is not a component of, a health insurance issuer
  4. To the extent practical and appropriate, the entity collects patient safety work product from providers in a standardized manner that permits valid comparisons of similar cases among similar providers
  5. The entity utilizes patient safety work product for the purpose of providing direct feedback and assistance to providers to effectively minimize patient risk


Excerpt from M. Lynn Sykes, The Patient Safety and Quality Improvement Act of 2005, 7 HOSPITALS & HEALTH SYSTEMS 3 (Nov. 2005).