MCARE Act and PSQIA: PA Superior Court Weighs in on Document Discovery
In Boyle v. Main Line Health, Inc., 2025 PA Super 148 (July 17, 2025) the Superior Court of Pennsylvania analyzed the Medical Care Availability and Reduction of Error (“MCARE”) Act, 40 P.S. §§ 1303.101-1303.910, and the Patient Safety and Healthcare Quality Improvement Act (“PSQIA”), 42 U.S.C. 299b-21, et seq, 42 C.F.R. Part III, §§ 3.10, et seq. in determining whether documents relating to the review and investigation of issues relating to Erin Boyle’s delivery of B.B. (“Boyle Event”) were discoverable.
The Boyles asserted claims for professional negligence against Main Line Health, Inc. (“Main Line”) and Dr. Scott Bailey arising out of the birth of their son, “BB”. The Boyles also asserted claims for negligent infliction of emotional distress regarding Erin Boyle, and loss of consortium regarding Erin and Stephen Boyle. During discovery, the Boyles requested the production of documents from the Main Line Defendants relating to the review and investigation regarding Erin Boyle’s delivery of B.B. In response to the request, the Main Line Defendants provided a privilege log identifying four documents Defendants claimed were privileged: (1) the Patient Safety Occurrence Worksheet (“PSOW”); (2) the Situation Background Assessment/Recommendations (“SBAR”); (3) the Patient Safety Reporting System (“PSRS”); and (4) the Potentially Compensable Event (“PCE”) report to Claims Management. The Main Line Defendants specified that the PSRS report was protected from disclosure under the MCARE Act, and the PSOW and SBAR were protected as confidential patient safety work product under the PSQIA. The Main Line Defendants admitted that no peer review was conducted, and they did not assert any privilege under the PRPA. The trial court ordered the production of the documents, and the Main Line Defendants appealed the court’s decision.
MCARE confidentiality extends to “documents, materials or information solely prepared or created for the purpose of compliance with section 310(b).” Ford-Bey v. Professional Anesthesia Services of North America, LLC, 229 A.3d 984 (Pa.Super. 2020 (quoting 40 P.S. § 1303.311(a)) (emphasis in original). party claiming a document is protected under section 311(a) need not demonstrate a patient safety committee or governing board actually reviewed the contested document.” Lahr v. Lehigh Valley Hosp., Inc., 311 A.3d 587, 2023 WL 8665017 *9 (Pa.Super. 2023) (unpublished memorandum). However, at a minimum “section 311(a) requires proof that the document, materials or information or reporting requirement arose out of ‘matters reviewed’ by a patient safety committee or a governing board pursuant to their section 311(b) responsibilities.” Id.
In this case, the Main Line Defendants failed to introduce evidence to show that Main Line’s patient safety committee or governing board had reviewed the Boyle Event. Therefore, the Court concluded that the PSRS report did not meet the criteria of privilege under section 311(a).
The Main Line Defendants created the SBAR and PSOW for the purpose of reporting to a patient safety organization and that the SBAR was reported to the ECRI PSO as part of the Hospital’s reporting system. The Main Line Defendants insist that these documents, “are quintessential examples of … documents that qualify for PSQIA privilege protection” under subsection (ii) of the PSQIA. (Main Line Defendant’s Brief at 45). Therefore, the Main Line Defendants insist that they have met their burden of establishing that the documents constituted privileged “patient safety work product” as defined by the PSQIA at Section 299b-21(7)(A).
PSQIA defines “patient safety work product” as follows:
Except as provided in subparagraph (B), the term ‘patient safety work product’ means any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements—
(i) which
(I) are assembled or developed by a provider for reporting to a patient safety organization and are reported to a patient safety organization; or
(II) 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
(ii) which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.
42 U.S.C. § 299b-21(7)(A). The PSQIA provides that “patient safety work product” shall be privileged and shall not be subject to a state subpoena, subject to discovery, or admitted as evidence. 42 U.S.C. § 299b-22(a).
Information that constitutes “patient safety work product” under the “deliberations or analysis” option set forth in section 299b-21(7)(A)(ii), is protected when it is done within the patient safety evaluation system. Notably, “‘patient safety work product’ excludes ‘information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system.’” Ungurian v. Beyzman, 232 A.3d 786, 795 (Pa.Super. 2020) (quoting 42 U.S.C. § 299b-21(7)(B)(ii)).
Here, the Court concluded that Mainline Medical produced the SBAR and PSOW solely in accordance with the patient safety evaluation system and reported to the patient safety organization and thus constituted “patient safety work product” privileged documents as the “deliberations or analysis of” a patient safety evaluation system. See 42 U.S.C. § 299b-21(7)(A)(ii). The Court noted that the burden now shifted to the Boyles “to set forth facts showing that disclosure will not violate the…privilege.” Ungurian, supra at 795.
The Superior Court’s opinion in Boyle v. Main Line Health, Inc., 2025 PA Super 148 (July 17, 2025) can be accessed here.
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