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Patient Safety and Quality Improvement Act

The Patient Safety and Quality Improvement Act of 2005[1] (PSQIA): Pub. L.Tooltip Public Law (United States) 109–41 (text) (PDF), 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 [I-VT]. 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.[2]


Context for the passage of the Act

The Notice of proposed rulemaking[3] for this law describes the reason Congress passed it.

Much of the impetus for this legislation can be traced to the publication of the landmark report, "To Err is Human",[4] 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. As compared to other high-risk industries, the health care system is behind in its attention to ensuring basic safety. The reasons for this lag are complex and varied. Providers are often reluctant to participate in quality review activities for fear of liability, professional sanctions, or injury to their reputations. Traditional state-based legal protections for such health care quality improvement activities, collectively known as peer review protections, are limited in scope: They do not exist in all States; typically they only apply to peer review in hospitals and do not cover other health care settings, and seldom enable health care systems to pool data or share experience between facilities. If peer review protected information is transmitted outside an individual hospital, the peer review privilege for that information is generally considered to be waived. This limits the potential for aggregation of a sufficient number of patient safety events to permit the identification of patterns that could suggest the underlying causes of risks and hazards that then can be used to improve patient safety.

Summary of the act's major sections

Definitions

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 are assembled or developed by a provider for reporting to a PSO and are reported to a PSO; or are developed by a patient safety organization for the conduct of patient safety activities; and which could result in improved patient safety, health care quality, or health care outcomes; or which identify or constitute the deliberations or analysis, or identify the fact of reporting pursuant to a patient safety evaluation system (42 USC 299b-21(7)(A)).

However, patient safety work product does not include a patient's medical record, billing and discharge information, or any other original patient or provider records; nor does it include information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system.

Privilege and confidentiality protections

Patient Safety Work Product must not be disclosed, except in very specific circumstances and subject to very specific restrictions.

Note: the Patient Safety Activities Exception is the most common one that providers and PSOs will be working with.

Permitted Disclosures

Violations & Enforcement

Note: the individual workforce member of the provider would still be subject to possible penalties if the disclosure is knowing or reckless. This safe harbor does not apply to the PSO itself — i.e., a PSO workforce member's disclosure is attributable to the PSO.

The Act is enforced by the Secretary of Health and Human Services

Network of patient safety databases

What is the Network of Patient Safety Databases?

Patient Safety Organization certification and listing

Listed PSO logo: only officially listed PSOs may display this logo.

See also

References

  1. ^ Patient Safety and Quality Improvement Act
  2. ^ S. 544 (109th) — Patient Safety and Quality Improvement Act of 2005 (GovTrack.us)
  3. ^ Patient Safety and Quality Improvement — Proposed Rule, Federal Register February 12, 2008, pages 8112–8183.
  4. ^ Kohn, Linda T.; Corrigan, Janet M.; Donaldson, Molla S., eds. (2000). To Err is Human—Building a Safer Health System. Washington, D. C.: National Academies Press. p. 312. ISBN 978-0-309-06837-6.

Further reading

External links