The Patient Safety and Quality Improvement Act of 2005 (Public Law 109-41) (“Act”), signed into law on July 29, 2005, was enacted in response to growing concern about patient safety in the United States and the Institute of Medicine’s 1999 report, To Err is Human: Building a Safer Health System. The stated goal of the Act was to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients.

The Act creates Patient Safety Organizations (PSOs) to collect, aggregate, and analyze confidential information reported by health care providers. By analyzing patient safety event information, PSOs are intended to identify patterns of failures and propose measures to eliminate patient safety risks and hazards. The Act provides federal legal privilege and confidentiality protections to information that is assembled and reported by providers to a PSO or developed by a PSO (“patient safety work product”) for the conduct of patient safety activities. The Act also significantly limits the use of this information in criminal, civil, and administrative proceedings, and includes provisions for monetary penalties for violations of confidentiality or privilege protections.

The so-called peer review privilege was considered necessary because medical providers “fear that patient safety event reports could be used against them in medical malpractice cases or in disciplinary proceedings.” The premise was that patient safety improvement efforts were being hampered by the fear of discovery of peer deliberations, resulting in under-reporting of events and an inability to aggregate sufficient patient safety event data for analysis.

The United States District Court for the District of New Mexico has ruled that the peer-review privilege contained in the federal Patient Safety and Quality Improvement Act preempts any state peer-review privilege. The preemption is limited to “patient safety work product” submitted to a certified Patient Safety Organization that a state peer-review privilege does not otherwise protect.  Quimbey v. Cmty. Health Sys. Prof’l Servs. Corp., 2016 WL 8716224 (D.N.M. Oct. 20, 2016).

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The U.S. Department of Health and Human Services stated: “The Patient Safety Act is part of a larger framework envisioned by the Institute of Medicine and designed to balance two goals: 1) To improve patient safety and reduce medical errors by creating a “culture of safety” to share and learn from information related to patient safety events, and 2) to promote health care providers’ accountability and transparency through mechanisms such as oversight by regulatory agencies and adjudication in the legal system. As discussed in “To Err Is Human,” in respect to reporting systems, “they can hold providers accountable for performance or, alternatively, they can provide information that leads to improved safety. Conceptually, these purposes are not incompatible, but in reality, they can prove difficult to satisfy simultaneously.””

“The Patient Safety Act promotes the goal of improving patient safety and reducing medical errors by establishing a system in which health care providers can voluntarily collect and report information related to patient safety, health care quality, and health care outcomes to PSOs. The PSOs aggregate and analyze this information and give feedback to the providers to encourage learning and prevent future errors. The providers are motivated to report such information to PSOs because the Patient Safety Act provides broad privilege and confidentiality protections for information meeting the definition of PSWP, which alleviates concerns about such information being used against a provider, such as in litigation.”

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One court has described the need for the peer review privilege as follows: “Confidentiality is essential to effective functioning of these staff meetings; and these meetings are essential to the continued improvement in the care and treatment of patients. Candid and conscientious evaluation of clinical practices is a sine qua non of adequate hospital care. To subject these discussions and deliberations to the discovery process, without a showing of exceptional necessity, would result in terminating such deliberations. Constructive professional criticism cannot occur in an atmosphere of apprehension that one doctor’s suggestion will be used as a denunciation of a colleague’s conduct in a malpractice suit.”

“The purpose of these staff meetings is the improvement, through self-analysis, of the efficiency of medical procedures and techniques. They are not part of current patient care but are in the nature of a retrospective review of the effectiveness of certain medical procedures. The value of these discussions and reviews in the education of the doctors who participate, and the medical students who sit in, is undeniable. This value would be destroyed if the meetings and the names of those participating were to be opened to the discovery process.”

Bredice v. Doctors Hospital, Inc., 50 F.R.D. 249 (D. D.C. 1970), aff’d, 479 F.2d 920 (D.C. Cir. 1973).

“Privileges can impose a hardship on litigants, excluding potentially relevant information from discovery. But they reflect a determination by legislatures and courts that sometimes this necessary evil is justified by a greater public good. The societal benefit advanced by medical peer review is the prevention of medical error and the concomitant reduction in morbidity and mortality. The justification for protecting peer review records is that compelling their disclosure would discourage their creation, sacrificing the social utility of patient safety to the needs of individual litigants. Physicians will be disinclined to assertively critique their peers if their statements entangle them in litigation and expose them to professional rifts.”

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The Health Care Quality Improvement Act (HCQIA) grants comprehensive legal immunity for peer reviewers.

All 50 U.S. states and the District of Columbia have enacted peer review privilege statutes. While their statutes vary in scope and description, all offer immunity to those who participate in peer review.

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