On July 29, 2005, the President signed the Patient Safety and Quality Improvement of Act (Patient Safety Act) into law. The goal of the Act was to improve patient safety by encouraging voluntary and confidential reporting of health care events that adversely affect patients. To implement the Patient Safety Act, the Department of Health and Human Services issued the Patient Safety and Quality Improvement Rule (Patient Safety Rule). The Patient Safety Act and the Patient Safety Rule authorize the creation of PSOs to improve quality and safety through the collection and analysis of aggregated, confidential data on patient safety events. This process enables PSOs to more quickly identify patterns of failures and develop strategies to eliminate patient safety risks and hazards. 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.
The Patient Safety and Quality Improvement Rule (Patient Safety Rule) contains two parts. The first part (73 FR 70732-70796s proposed approach in the NPRMs final decision, and how the Department responded to those comments.
- Subpart A defines essential terms, such as patient safety work product, patient safety evaluation system, and PSO. The definitions apply to all of the other Subparts.
- Subpart B provides the requirements to become and remain listed as a PSO.
- Subpart C describes the privilege and confidentiality protections that attach to patient safety work product (PSWP) and lists the only circumstances in which PSWP can be disclosed.
- Subpart D establishes a framework to enable HHS to monitor and ensure compliance with the confidentiality provisions, a process for imposing a civil money penalty for breach of the confidentiality provisions, and hearing procedures.
The second part (73 FR 70796-70814) is the regulatory text that serves as the legal basis on which the Department will interpret and enforce the provisions of the Patient Safety Act.
The Notice of Proposed Rulemaking (NPRM) provides a view of key concepts that were incorporated into the final Patient Safety Rule, such as the distinctions between the pathways by which information becomes PSWP and the role of a PSES. In addition, the Patient Safety Rule incorporated some provisions from the NPRM without change; in those cases, the discussion in the NPRM preamble may also prove useful.
On December 30, 2010, HHS issued a Patient Safety Guidance document to address questions about the obligations of PSOs that are also required to report certain information to the FDA under the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations.
The Guidance states that a PSO that is a component of a parent organization that includes an FDA-regulated entity cannot create a conflict of interest for its parent organization by extending PSWP protections to information that the regulated entity is required to report to the FDA under the FDCA. Therefore, for such an entity to become listed as a component PSO, the entity must agree to disclose PSWP to both its parent and the FDA, when required.
The Patient Safety Guidance applies to:
- All entities that have mandatory FDA-reporting obligations under the Food, Drug and Cosmetic Act (FDCAor
- Entities that are organizationally related to such FDA-regulated reporting entities (e.g., parent organizations, subsidiaries, sibling organizations).
The Patient Safety Rule authorizes AHRQ to conduct reviews (including announced or unannounced site visits) to assess a s compliance with listing requirements. To help PSOs make the required attestations and prepare for a compliance review, AHRQ developed Patient Safety Organizations: A Compliance Self-Assessment Guide to suggest approaches for thinking systematically about the scope of these requirements and what compliance may mean for an individual PSO.
Whether your organization is considering seeking listing as a PSO or your PSO is already established, consider the checklists of questions found within the PSO Compliance Self-Assessment Guide as a starting point. The document contains four tables that will help PSOs determine if its approach to compliance has taken into account all of the most relevant questions and issues, given its mission, the services and expertise it offers providers, and its model for carrying out patient safety activities.
- Table 1 provides sample questions related to the eligibility, listing, and operational requirements that are set forth in section 3.102 of the Patient Safety Rule.
- Table 2 provides sample questions related to the requirements for the security of patient safety work product set forth in section 3.106.
- Table 3 lists the submission and notification requirements that PSOs, and entities seeking listing as a PSO, must meet. It indicates whether a specific form must be used and the date by which the requirements must be met, if one is specified in the Patient Safety Rule.
- Table 4 is a reference table that provides a cross-walk of the attestations required for initial and continued listing. It also includes the corresponding requirements from the Patient Safety Rule and a reference table that provides a cross-walk of the attestations required to be listed as a PSO to maintain listing. It also includes the corresponding requirements from the Patient Safety Rule.