OBJECTIVE: To 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 SOURCES: Relevant 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 EXTRACTION: All relevant publications were reviewed. Summarization of the PSQIA was carried out by legal textual analysis.

DATA SYNTHESIS: PL 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.

CONCLUSIONS: The 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.

Key Words: legislation, medication errors, patient safety, quality improvement

Published Online, 8 Nov 2005, www.theannals.com, DOI 10.1345/aph.1E638

THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER: 407-000-05-036-H01