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Pennsylvania court interprets scope of Patient Safety Act privilege protections

A recent Pennsylvania appellate court opinion related to the Patient Safety and Quality Improvement Act (“PSQIA”) continues a trend of judicial erosion of patient safety privilege protections afforded to health care providers by statute. 

In the most recent Pennsylvania appellate court opinion related to the Patient Safety and Quality Improvement Act (“PSQIA”), the state Superior Court in its Ungurian v. Beyzman decision continues a trend of judicial erosion of patient safety privilege protections afforded to health care providers by statute.  The limits of a hospital’s patient safety privilege emerge in medical malpractice actions, as it did in Ungurian, where a plaintiff has suffered grave injury after seeking medical care.

These cases involve highly complicated delivery and standards of medical care that have evolved over decades and feature battles over which documents are subject to disclosure and which are protected by patient safety privileges.  The PSQIA and related privileges exist to allow hospitals to review their mistakes and generate service improvement, facilitating a culture of patient safety.  The purpose of these evidentiary protections, in short,  is not to protect the individual providers or facilities but to improve the health care system as a whole.

Courts have strictly construed evidentiary privileges that are often perceived as impediments to plaintiffs obtaining a complete picture of their medical care.  For a hospital to benefit from evidentiary and confidentiality protections available under the statute, hospitals and other healthcare providers must be vigilant to adhere to the letter of relevant privilege standards because, should they stray from strict compliance, the court will not enforce those protections.  In the Ungurian case, the court looked at the rules as described below and found the hospital was not in strict compliance and therefore the plaintiff was entitled to receive information that otherwise would have been privileged.

The PSQIA was enacted by Congress in 2005 with the goal to improve patient safety by establishing a system for health care providers to voluntarily collect, review, and report information related to patient safety, health care quality, and health care outcomes to Patient Safety Organizations (“PSO”), which aggregate and analyze this information.  The authors address the PSQIA and related patient safety privileges in greater detail in this MedCity News article.

Ungurian v. Beyzman
In an April 28 decision, the Superior Court of Pennsylvania addressed the application of PSQIA, 42 U.S.C. § 299b -22 et. seq., and the Peer Review Protection Act (“PRPA”), 63 P.S. § 425.4.  In Ungurian v. Beyzman, a case involving Wilkes-Barre General Hospital, a health system and various health care providers, the appeals court rejected the Hospital’s claims that documents withheld from discovery were afforded protection under either the PSQIA or PRPA.

In this medical malpractice action, plaintiff Susan Ungurian alleged the defendants negligently caused the permanent incapacity of her son who was undergoing a cystoscopy (kidney stone surgery) at the hospital.  Ungurian sought several documents during discovery, including:

  • Event Reporting by Dr. Burry (“Burry Event Report”) concerning the Hospital’s medical services;
  • Serious Safety Event Rating (“SSER”) Meeting Summary;
  • Meeting Minutes from the Patient Safety Committee;
  • Root Cause Analysis Report;
  • The hospital’s Quality Improvement Staff Peer Review.

Wilkes-Barre General Hospital asserted the Burry Event Report and Root Cause Analysis were patient safety work product privileged under the PSQIA.  The defendant also argued the PRPA privilege applied to all of the listed documentation.  The three-judge Superior Court panel made up of Judges Alice Beck Dubow, Anne Lazarus, and Victor Stabile disagreed.

Patient Safety and Quality Improvement Act ClaimsThe PSQIA provides privilege and confidentiality protections to data collected and analyzed for the purpose of being reported to a PSO.  To avail itself of these protections, a health care provider must set up a Patient Safety Evaluation System (“PSES”) that manages the process of collecting, analyzing and ultimately reporting information to a PSO.  Data that flows through the PSES is considered Patient Safety Work Product (“PSWP”) and is subject to confidentiality and privilege protections, meaning the data is not discoverable in litigation.

With regard to the Burry Event Report and Root Cause Analysis, the Ungurian court found the hospital’s argument fell short of the requirements under PSQIA.  “We agree with the trial court’s analysis that the PSQIA requires that, in order to be considered patient safety work product, hospital had the burden of initially producing sufficient facts to show that it properly invoked the privilege,” Dubow wrote in the opinion.  “Stated another way, hospital had to allege that it prepared the Burry event report for reporting to a PSO and actually reported them to a PSO.  Because hospital did not so allege, it did not meet its burden to establish that the Burry event report was entitled to protection under the PSQIA’s patient safety work product privilege.”

The PSQIA requires that, in order to be considered PSWP, information must be gathered for the sole purpose of reporting to a PSO.  The Ungurian court found the PSQIA did not apply because Wilkes-Barre General Hospital did not demonstrate that these documents were prepared for the singular purpose of reporting to a PSO.  This decision reveals the critical importance of health care providers being vigilant in written adherence and strict implementation of the PSQIA to withstand challenges based on the absence of strict compliance.

Peer Review Protection Act Claims
A similar analysis unfolded with regard to the PRPA claims.  At each step, the court clung to strict interpretations of statutory definitions to deny the Hospital’s privilege assertions.  The PRPA provides immunity and confidentiality to health care providers related to the review of patient care.   The purpose of the PRPA is to encourage providers to improve the quality of patient care by conducting this review.  The Ungurian court ruled the PRPA privilege did not apply to the Burry Event Report because Hospital did not generate the report during the course of peer review. Instead, the report was produced in accordance with the hospital’s Event Reporting Policy and is in the nature of an incident report, meaning a simple, factual recitation of what occurred, versus a retrospective review and analysis of issues that arose during the course of care.  As for the Root Cause Analysis, the court ruled that because the PRPA privilege only applies to the observations of and materials produced during an evaluation by “professional health care providers,” th hospital’s failure to identify the members of the Root Cause Analysis Committee as “professional healthcare providers” was fatal to the privilege claim.

Similarly, the hospital’s argument that the Quality Improvement Medical Staff Peer Review was covered by the PRPA also failed because the document was prepared by Dr. Dale Anderson of an organization called North American Partners in Anesthesia (“NAPA”), a named defendant in the case.  In the opinion, Dubow stated “We agree with the trial court that, in order for the PRPA privilege to apply to the quality improvement medical staff peer review, hospital had to prove that a ‘professional healthcare provider’ conducted it.  Neither Dr. Anderson nor the NAPA defendants are ‘professional healthcare providers’ under the PRPA [because Dr. Anderson’s medical license had expired and NAPA is not an individual permitted to practice medicine], and, as noted by the trial court, hospital did not proffer anything more than bald allegations to support its claim that Dr. Anderson performed the quality improvement medical staff peer review at its request.”

Wilkes-Barre General Hospital also asserted a PRPA claim pertaining to the SSER Meeting Summary and Patient Safety Committee Meeting Minutes.  The panel found it failed to demonstrate the SSER Meeting Summary is “privileged peer review information” under the PRPA because Hospital did not show that the members of the SSER Committee are “professional healthcare providers” under the PRPA.  Hospital asserted the committee members work on behalf of and at the request of Hospital, which is a “professional healthcare provider” under the PRPA.  The court did not agree, noting the absence of evidence to support each committee member as a professional healthcare provider, as that term is defined under the PRPA.

Finally, with regard the PRPA claim related to the credentialing files, the court cited Reginelli v. Boggs in finding that credentialing review is not entitled to protection from disclosure under PRPA – as the credentialing committee does not qualify as a “review committee.”

Look Forward
Ungurian follows a decision from a different Pennsylvania three-judge Superior Court panel, also led by Dubow, which requested clarification regarding the Pennsylvania Supreme Court’s holding in Reginelli pertaining to credentialing records.  In Leadbitter v. Keystone Anesthesia Consultants, the Superior Court sought guidance regarding how to handle credentialing records generated by peer review committees.  A petition for allowance of appeal in the Leadbitter case is pending before the state Supreme Court.  If the Court takes up the case, reference will no doubt be made to Justice Wecht’s dissenting opinion in Reginelli, in which he implores lower courts to not be so narrowly focused on the definitions in the PRPA that the privilege protections are eviscerated.  Wecht calls upon the hospital community to educate the courts on the proper divisions between what is discoverable and what documentation can, if properly privileged, be critical to improving patient safety.

Photo: artisteer, Getty Images

Charles Kelly, a partner at Saul Ewing Arnstein & Lehr, is a highly regarded litigator with extensive experience handling media, healthcare and complex commercial litigation. He regularly litigates cases in federal, state and bankruptcy courts.

Charlie's clients range from Fortune 100 to small start-up companies that he represents for complex litigation issues, including breach of contract, tort, quasi-contract, fraud, negligent misrepresentation, copyright, trademark, trade name, libel, shareholder disputes, labor advice (including discrimination, constructive discharge, sexual harassment and disability matters) and non-compete and trade regulation/anti-trust claims. His clients operate in numerous industries, including food and pharmaceutical distribution, media, healthcare, specialty scrap, automotive and energy, among others.

Charlie advises clients in the hospital and ambulance industries on healthcare issues such as Medicare and Medicaid regulations, False Claims Act cases and sophisticated coding and reimbursement issues.

Samantha Gross is an associate at Saul Ewing Arnstein & Lehr. She represents and counsels health care providers in regulatory and transactional matters. Samantha's experience includes drafting and negotiating contracts related to physician arrangements, health care mergers and acquisitions, and group purchasing organizations (GPOs). Her regulatory experience includes counseling on hospital operations, medical staff issues, changes in ownership, regulatory licensing, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as federal and state fraud and abuse laws.

Samantha brings a diverse perspective to her representations of hospitals, physician groups, long-term care organizations, GPOs, and pharmacies. In addition to her work in private practice at a national law firm, Samantha has previously worked as in-house counsel for a Philadelphia health system. In addition to her law degree, she has a Master's of Public Health from the University of Pennsylvania.

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