In July 2005, Congress developed the federal Patient Safety and Quality Improvement Act of 2005 in response to the Institute of Medicine report, To Err Is Human. The final Patient Safety Rule was adopted November 21, 2008 and became effective on January 19, 2009. The Agency for Healthcare Research and Quality, one of the eleven divisions under the Department of Health and Human Services, oversees the Patient Safety Rule.

The Patient Safety Act and the Patient Safety Rule provide a structure for PSOs while the legislation affords protection for physicians and healthcare providers that voluntarily and confidential reporting of adverse event information to designated PSOs.  The program intentionally differentiates PSO work from most regulatory and mandatory reporting programs.

In 2008, the Center for Patient Safety was the 5th federally-designated PSO in the country. The goal of the Center for Patient Safety PSO is to learn how and why events are occurring, and inform providers and others about how to prevent future occurrences.

The Patient Safety Act and the Patient Safety Rule reinforce a safety culture that encourages and allows healthcare providers to safely report and share information about vulnerabilities within the healthcare system. The Act extends confidentiality and privilege protections to:

• Eligible information developed by providers for reporting to a PSO (but not to information developed for other purposes)
• Deliberations and analyses conducted by either a PSO or a provider in its respective patient safety evaluation system (PSES)
• Information developed by a PSO for the conduct of patient safety activities

When a provider works with a PSO, many of the long-recognized impediments to successful improvement projects can be overcome:

• Provider fear of increased liability from participating in quality initiatives. The law provides confidentiality protections and privilege protections (inability to introduce the protected information in a legal proceeding), when certain requirements are met.
• Enables all licensed or certified health care facilities and clinicians to participate. Unlike state protections that often target hospitals or physicians, these protections are broad.
• Protections are nationwide and uniform. This is especially valuable for systems with facilities in multiple states; a corporate system can share its protected data system-wide with all of its affiliated providers, if it chooses to do so.
• Insufficient volume. Patient safety events are often too rare for a facility to identify causal factors with certainty.  Each provider benefits from the insights that it can obtain from a PSO that aggregates large volumes of event data from multiple providers.  Moreover, your data remains protected even when the PSO is aggregating it with data from other providers.
• Lack of feedback. The quantity and types of data you report to a PSO and the specific types of analysis and feedback you want are a matter for negotiation with the PSO.  They are not determined by regulation.
• Inability to protect deliberations or analyses at your facility. The law permits providers to undertake deliberations and analyses at their facilities that become protected as Patient Safety Work Product immediately as long as they are conducted in the provider’s Patient Safety Evaluation System.

• Patient Safety Act
• Patient Safety Rule
• Notice of 2008 Proposed Rulemaking
• Patient Safety Guidance
• Compliance Self-Assessment Guide
• More Patient Safety Resources
• National Health Reform Provisions and PSOs
• Legal Environment Scan