The Medical Care Availability and Reduction of Error (MCARE) Act, 40 Pa. C.S. Section 1303.101, et. seq., contains provisions which create an institutional “patient safety” process, and provides protections—contained in Section 1303.311— that afford to health care institutions the ability to report and investigate “serious events or incidents,” and develop and implement solutions to systemic patient safety problems that may lead to future “serious events or incidents” discovered thereby, free from concern about exposure during litigation discovery.

The MCARE Act proscribes the requirements for the creation and implementation of a hospital's “Patient Safety Plan” (Section 1303.307); the creation and making of “Patient Safety Reports” by hospital personnel (Section 1303.308); the duties and rights of a hospital's “Patient's Safety Officer” (Section 1303.309); and the formation and conduct of a hospital's “Patient Safety Committee” (Section 1303.310). It is within the context of these processes and personnel that the protections set forth in Section 1303.311 apply.

Under Section 1303.311(a) of the MCARE Act, “any documents, materials or information solely prepared or created for the purpose of compliance with [the various patient safety provisions of the MCARE Act] which arise out of matters reviewed by the patient safety committee … or the governing board of a medical facility … are confidential and shall not be discoverable or admissible as evidence in any civil or administrative action or proceeding.” Section 1303.311(a) further contains an “original source” exception which provides that any documents, materials or records “that would otherwise be available from original sources shall not be construed as immune from discovery … merely because they were presented to the patient safety committee or governing board of a medical facility.”

Section 1303.311(b) addresses testimonial immunity, and provides: “No person who performs responsibilities for or participates in meetings of the patient safety committee or governing board of a medical facility … shall be allowed to testify as to any matters within the knowledge gained by the person's responsibilities or participation [in connection with same], provided, however, the person shall be allowed to testify as to any matters within the person's knowledge which was gained outside of the person's responsibilities or participation on the patient safety committee or governing board of a medical facility.”

Section 1303.311(c) limits the applicability of Sections 1303.311(a) and (b) “to the documents, materials or information prepared or created pursuant to the responsibilities of the patient safety committee or governing board of a medical facility.”

It is becoming ever more important for health care institutions to ensure that their understanding of, and literal compliance with, the provisions of the MCARE Act's Patient Safety protections afforded by Section 1303.311 are up-to-date. The meaning and limits of the protections afforded under Section 1303.311 have been addressed by various courts in the commonwealth, and with increasing frequency, in recent years. Particularly close attention has been paid by these courts to the following key phrases: “solely prepared or created for the purpose of compliance with;” “reviewed by the patient safety committee;” “prepared or created pursuant to the responsibilities of the patient safety committee;” “original source document;” and “gained by” vs. “gained outside” the person's “responsibilities or participation on the patient safety committee”.

In Haines v. Cherian, M.D., 2016 U.S. Dist. LEXIS 24522, 2016 WL 831946 (M.D. Pa., 2016), the U.S. District Court for the Middle District of Pennsylvania, while applying Pennsylvania law, addressed a claim by a hospital that certain documents were immune from discovery under Section 1303.311. In rendering its decision, the Haines court took note of Lackawanna County Judge R. Terrence Nealon's trial court opinion in Venosh v. Henzes, No. 11 CV 3058, 31 Pa.D.&C. 5th 411 (2013)—which will be discussed in more detail below.

The Haines court determined that “if the investigation of an incident by the defendant hospital was not 'commenced at the request of or by the defendant's Patient Safety Committee,' the confidentiality protections afforded by Section 311(a) are inapplicable.'” The Haines court went on: “absent proof 'that the [Quality Assurance Review] forms were reviewed by a patient safety committee or by the hospital's governing board,' the confidentiality provisions of Section 311(a) have no application.” After reviewing the documents in question in camera, the Haines court found that documents that were not marked as having been prepared solely for purposes of the MCARE Act's patient safety committee's responsibilities were required to be produced in discovery.

In Lesterick v. Singh, 47 Pa.D.&C. 5th 193 (2015), Allegheny County Judge R. Stanton Wettick considered “the merit of defendants' contention that a report of a charge nurse is protected from discovery by Section 311.” Judge Wettick held that, in order for the protections of Section 311(a) to apply, a report by a health care worker about an incident must have been made with a “reasonable belief that a serious event or incident has occurred.”

Wettick determined that the nurse in question “did not testify that she prepared the report because she reasonably believed that this was a serious event or incident which mandated the preparation of a report.” Wettick also determined that a health care worker's report of “the event or incident” must specifically be created and submitted in a manner which is in “accord [with the patient safety plan of the medical facility.”

In Venosh v. Henzes, 31 Pa.D.&C. 5th 411 (2013), Judge Nealon considered whether two “incident reports” prepared by defendant hospital needed to be produced in discovery. Judge Nealon concluded: “if the investigation of an incident by the defendant hospital was not 'commenced at the request of or by the defendant's Patient Safety Committee',” the confidentiality protection afforded by Section 311(a) are inapplicable” and “absent proof 'that the [Quality Assurance Review] forms were reviewed by a patient safety committee or by the hospital's governing board,' the confidentiality provisions of section 311(a) have no application.”

An important caveat to reliance upon Venosh exists. While many subsequent courts cite to the general reasoning articulated by Judge Nealon in Venosh about the Section 1303.311(a)'s protections, the underlying facts of Venosh give that case a remarkably narrow scope—and make other cases easily distinguishable from it on their facts. The two incident reports in Venosh were held by Judge Nealon to have been “created pursuant to [the hospital's internal] operating policy 50–85–1 to, inter alia, make a record of the incident for litigation purposes and compile data to evaluate event trends.” All of Judge Nealon's pronouncements about Section 1303.311(a) beyond that very narrow factual scope are dicta. Any attempt to invoke Venosh and its progeny as the basis for piercing the protections afforded by Section 1303.311 should be met by the argument that Venosh is factually inapplicable because it was based upon peculiar, obviously problematic, language contained in a particular hospital's specific “operating policy” (which, again, expressly stated that data being compiled was not for purposes of compliance with Section 1303.311 but, instead, for “litigation purposes”).

What is clear from all of the recent case law is that there are serious attempts afoot to narrow the applicability of the patient safety protections afforded by the MCARE Act under Section 1303.311. In order to obtain the significant advantages that Section 1303.311 offers, it is imperative that hospitals review and hone their patient safety processes and protocols so that they are being correctly utilized—and, therefore, are not subject to a claim of waiver. While the patient safety protections afforded by Section 1303.311 can be used to insulate a hospital from having to disclose its post-serious event reports, investigations, and responses, failing to comply with the technical requirements of the act—related to the Patient Safety Plan, the Patient Safety Officer, Patient Safety Reports, and the Patient Safety Committee—can expose that entire system to discovery and use against a hospital at trial.

Andrew Ralston of White and Williams focuses his practice on the defense of professional liability claims for physicians, hospitals and health care professionals, as well as other licensed professionals. He also handles zoning and land use appeals litigation, commercial litigation, and insurance defense litigation. He can be reached at [email protected].