New legal protections for reporting patient errors under the Patient Safety and Quality Improvement Act: a review of the medical literature and analysis

J Patient Saf. 2010 Sep;6(3):147-52. doi: 10.1097/pts.0b013e3181ed623a.


Objectives: The Patient Safety and Quality Improvement Act (PSQIA) of 2005, inspired by the Institute of Medicine's (IOM) 1999 report To Err Is Human, affords federal protections in exchange for error disclosures. However, the PSQIA is unlikely to be effective unless frontline providers are aware of its existence. In this study, we assessed the quantity of publications regarding this protection within the medical literature.

Methods: Four reviewers independently evaluated 2060 safety-related articles, identified through a PubMed database search, to determine whether they discussed actual (or proposed) national legal protections for voluntary reporting of medical errors. Using a reviewer method based on a standard Delphi consensus model, agreement was achieved if at least 3 of 4 reviewers agreed with the decision.

Results: Articles were separated into pre-IOM report (1990-1999) and post-IOM report (2000-2008) literature. No articles were determined to be "on topic" in the pre-IOM period (n = 624). Twenty-seven articles were considered "on topic" in the post-IOM period (n = 1436), constituting 1.8% of the period total (95% confidence interval, 1.2%-2.6%). Of the 27 on topic articles, 7 appeared in practice-related journals, whereas the remaining 20 were in journals with a health policy or health care administration focus.

Conclusions: Few published studies were found in clinical journals describing the PSQIA. This raises serious concerns and indicates that physicians may not be aware of the new legal protections afforded for error disclosure. If the health care system is to realize the benefits of error reporting systems, greater education of physicians regarding their legal protections may be needed.

Publication types

  • Review

MeSH terms

  • Health Knowledge, Attitudes, Practice
  • Humans
  • Medical Errors / legislation & jurisprudence*
  • National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division
  • Physicians
  • Public Policy
  • Safety Management / legislation & jurisprudence*
  • Truth Disclosure*
  • United States