Patient Safety and Quality Improvement Act

The Patient Safety and Quality Improvement Act of 2005 (PSQIA): Pub.L. 109–41, 42 U.S.C. ch. 6A subch. VII part C, established a system of patient safety organizations and a national patient safety database. To encourage reporting and broad discussion of adverse events, near misses, and dangerous conditions, it also established privilege and confidentiality protections for Patient Safety Work Product (as defined in the act). The PSQIA was introduced by Sen. Jim Jeffords . It passed in the Senate July 21, 2005 by unanimous consent, and passed the House of Representatives on July 27, 2005 with 428 Ayes, 3 Nays, and 2 Present/Not Voting.Much of the impetus for this legislation can be traced to the publication of the landmark report, 'To Err is Human', by the Institute of Medicine in 1999 (Report). The Report cited studies that found that at least 44,000 people and potentially as many as 98,000 people die in U. S. hospitals each year as a result of preventable medical errors. Based on these studies and others, the Report estimated that the total national costs of preventable adverse events, including lost income, lost household productivity, permanent and temporary disability, and health care costs to be between $17 billion and $29 billion, of which health care costs represent one-half. One of the main conclusions was that the majority of medical errors do not result from individual recklessness or the actions of a particular group; rather, most errors are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent adverse events. Thus, the Report recommended mistakes can best be prevented by designing the health care system at all levels to improve safety—making it harder to do something wrong and easier to do something right. The Patient Safety and Quality Improvement Act of 2005 (PSQIA): Pub.L. 109–41, 42 U.S.C. ch. 6A subch. VII part C, established a system of patient safety organizations and a national patient safety database. To encourage reporting and broad discussion of adverse events, near misses, and dangerous conditions, it also established privilege and confidentiality protections for Patient Safety Work Product (as defined in the act). The PSQIA was introduced by Sen. Jim Jeffords . It passed in the Senate July 21, 2005 by unanimous consent, and passed the House of Representatives on July 27, 2005 with 428 Ayes, 3 Nays, and 2 Present/Not Voting. Lexology, in cooperation with the Association of Corporate Counsel, predicts that this law will be one of the top 10 health care law issues in 2010. This reference should be actualized by stakeholders. The Notice of proposed rulemaking for this law describes the reason Congress passed it. Patient Safety Organization (PSO) must certify that it supports the requirements in the PSQIA and be listed on the Agency for Healthcare Research and Quality (AHRQ) web site. The definition of Patient Safety Work Product (PSWP) is quite broad. Patient safety work product includes any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements (or copies of any of this material), which could improve patient safety, health care quality, or health care outcomes, that are assembled or developed by a provider for reporting to a PSO and are reported to a PSO. It also includes information that is documented as within a patient safety evaluation system that will be sent to a PSO and information developed by a PSO for the conduct of patient safety activities. However, patient safety work product does not include a patient's medical record, billing and discharge information, or any other original patient or provider information; nor does it include information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system.