• William E Fassett.
• Department of Pharmacotherapy, College of Pharmacy, Washington State University-Spokane, PO Box 1495, Spokane, WA 99210-1495, USA. fassett@wsu.edu
• Ann Pharmacother. 2006 May 1; 40 (5): 917-24.

ObjectiveTo review Public Law (PL) 109-41-the Patient Safety and Quality Improvement Act of 2005 (PSQIA)-and summarize key medication error research that contributed to congressional recognition of the need for this legislation.Data SourcesRelevant publications related to medication error research, patient safety programs, and the legislative history of and commentary on PL 109-41, published in English, were identified by MEDLINE, PREMEDLINE, Thomas (Library of Congress), and Internet search engine-assisted searches using the terms healthcare quality, medication error, patient safety, PL 109-41, and quality improvement. Additional citations were identified from references cited in related publications.Study Selection And Data ExtractionAll relevant publications were reviewed. Summarization of the PSQIA was carried out by legal textual analysis.Data SynthesisPL 109-41 provides privilege and confidentiality for patient safety work product (PSWP) developed for reporting to patient safety organizations (PSOs). It does not establish federal mandatory reporting of significant errors; rather, it relies on existing state reporting systems. The Act does not preempt stronger state protections for PSWP. The Agency for Healthcare Research and Quality is directed to certify PSOs and promote the establishment of a national network of patient safety databases. Whistleblower protection and penalties for unauthorized disclosure of PSWP are among its enforcement mechanisms.ConclusionsThe Act protects clinicians who report minor errors to PSOs and protects the information from disclosure, but providers must increasingly embrace a culture of interdisciplinary concern for patient safety if this protection is to have real impact on patient care.

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