New law legally protects adverse event information

Pharmacists should be encouraged to report medication adverse events (AEs) and their underlying causes under a new law signed by President Bush on July 29.

The Patient Safety and Quality Improvement Act of 2005 amends the Public Health Service Act to designate patient safety data as privileged and confidential. The data are therefore legally protected.

The law also prevents accrediting bodies from taking action based upon a health professional reporting this information. One accrediting body, the Joint Commission on Accreditation of Health-care Organizations, has hailed this law as a "a breakthrough in the blame and punishment culture that has literally held a death grip on health care."

The American Medical Association has studied this law and presents the following summary:

  • The law establishes a confidential reporting structure in which physicians, hospitals, and other health care professionals and entities can voluntarily report confidential and legally privileged "Patient Safety Work Product" (PSWP) on errors to certified Patient Safety Organizations (PSOs), as part of a "Patient Safety Evaluation System."
  • PSOs would analyze PSWP, provide feedback to providers, and may report nonidentifiable PSWP to a database (which may be linked to a network of databases facilitated by the Department of Health and Human Services [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.
  • The law defines the circumstances under which PSWP may be 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.
  • The law does not preempt stronger state protections.
  • An adverse event 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.
  • The confidentiality protections of the Health Insurance Portability and Accountability Act of 1996 are maintained.
  • HHS, through the Agency for Healthcare Research and Quality, will report on methods to reduce errors and increase patient safety.
  • HHS is required to facilitate a network of databases to provide interactive evidence-based management resources for providers, PSOs, and others.