Summary of S. 544

Summary of S. 544/H.R. 3205, the “Patient Safety and Quality Improvement Act of 2005”

In general, S. 544/H.R. 3205 establishes a confidential reporting structure in which physicians, hospitals, and other health care professional and entities can voluntarily report information on errors to Patient Safety Organizations (PSOs).  PSOs, in turn, would analyze the data to develop patient safety improvements strategies.

The legislation stipulates that patient safety information will be confidential and legally protected, and provides appropriate penalties for unlawful disclosures.   It also preserves confidentiality of patient information under the Health Insurance Portability and Accountability Act of 1996.

The bill does not shield information available outside of a patient safety evaluation system, such as medical and billing records.

The legislation is designed to strike the proper balance between maintaining confidentiality and legal protections for reporting error information, and maintaining accountability and patients’ legal rights.

Under the major provisions of the Patient Safety and Quality Improvement Act of 2005:

• “Providers,” including physicians, could voluntarily report confidential and legally privileged “Patient Safety Work Product” (PSWP) to a certified “Patient Safety Organization[s]” (PSO) as part of a “Patient Safety Evaluation System.”
• PSOs would analyze PSWP, provide feedback to providers, and may report non-identifiable PSWP to a database (which may be linked to a network of databases facilitated by HHS).
• PSOs may be public or private and must meet certain defined criteria to be certified by HHS.
• PSWP cannot be used in civil, criminal, or administrative proceedings (including disciplinary actions) against a provider.
• Information on a crime is not PSWP and not privileged or confidential.
• Defines the circumstances under which PSWP may be made disclosed without violating or waiving confidentiality and legal privilege.
• Information or evidence available from original records (e.g., medical records), and information that is not PSWP and can be collected under other laws (e.g., state reporting requirements), would not be limited or affected.
• Stronger state protections are not preempted.
• An adverse action cannot be taken for good faith reporting of PSWP to a PSO.
• An accrediting body cannot take an accrediting action against a provider based on the provider's good faith participation in reporting PSWP.
• HIPAA confidentiality protections are maintained.
• HHS, through AHRQ, will report on methods to reduce errors and increase patient safety.
• HHS required to facilitate a network of databases to provide interactive evidence-based management resources for providers, PSOs, and others.