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MEDICAL MALPRACTICE – DISCOVERY – PRIVILEGED MATERIALS – PEER REVIEW – PROCEDURE

Boyle v. Main Line Health, Inc., 2022 Pa. Super. Unpub. LEXIS 71 (July 17, 2025) King, J.

OPINION BY KING, J.: Appellants, Main Line Health, Inc., Main Line Hospitals, Inc., Main Line HealthCare, and Scott Bailey, M.D. (collectively, “Main Line Defendants”), appeal from the order entered in the Montgomery County Court of Common Pleas, which granted the discovery motion of Erin and Stephen Boyle, parents and natural guardians of B.B., a minor (collectively, “the Boyles”). We affirm in part and reverse in part.

“Pennsylvania courts have held that discovery orders involving potentially confidential and privileged materials are immediately appealable as collateral to the principal action.” Berkeyheiser v. A-Plus Investigations, Inc., 936 A.2d 1117, 1123-24 (Pa.Super. 2007). See also Farrell v. Regola, 150 A.3d 87, 95 (Pa.Super. 2016), appeal denied, 641 Pa. 464, 168 A.3d 1259 (2017)

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 asserted that the documents were privileged pursuant to the Medical Care Availability and Reduction of Error (“MCARE”) Act and the Patient Safety and Healthcare Quality Improvement Act (“PSQIA”).

The party asserting a privilege bears the burden of producing facts establishing proper invocation of the privilege. Custom Designs & Mfg. Co. v. Sherwin-Williams Co., 39 A.3d 372, 376 (Pa.Super. 2012)[, appeal denied, 618 Pa. 688, 57 A.3d 71 (2012)]. “[T]hen the burden shifts to the party seeking disclosure to set forth facts showing that disclosure will not violate the … privilege.” Id. (citation omitted). “Absent a sufficient showing of facts to support [a] privilege … the communications are not protected.” Ford-Bey v. Professional Anesthesia Services of North America, LLC, 229 A.3d 984, 991 (Pa.Super. 2020)[, appeal denied, 663 Pa. 444, 242 A.3d 1251 (2020)]. Ungurian v. Beyzman, 232 A.3d 786, 795 (Pa.Super. 2020).

This Court discussed the MCARE Act privilege in Ford-Bey, where the plaintiff’s estate sued the hospital for medical malpractice after Ms. Ford-Bey suffered cardiac and respiratory failures following wrist surgery and remained in a vegetative state after the surgery until she died about a month later.

This Court explained that “aside from Gill’s filing with the PPSA a report, which the trial court held remained confidential, [the h]ospital failed to produce evidence demonstrating Gill solely prepared or created her notes for the purpose of complying with MCARE.”

This Court again considered the applicability of the MCARE Act’s section 311(a) statutory privilege in a recent unpublished decision, Lahr v. Lehigh Valley Hosp., Inc., 311 A.3d 587, 2023 WL 8665017 (Pa.Super. 2023) (unpublished memorandum). In that case, Ms. Lahr sued Lehigh Valley Hospital, Lehigh Valley Physicians Group, and the attending physicians for medical malpractice and other claims after her newborn baby died of complications related to infections. During discovery, Ms. Lahr moved to compel the hospital to produce patient safety reports regarding herself and/or her newborn. The hospital asserted that the patient safety reports were immune from discovery under MCARE and PRPA. The trial court conducted a hearing during which it heard testimony concerning the hospital’s patient safety reporting policy.

Therefore, this Court held that section 311(a) does not apply simply because the patient safety reports are the types of documents typically reviewed by a patient safety committee.

Instantly, the Main Line Defendants offered the affidavit of Nanci Gallagher, RN, who was working as the MCARE patient safety officer at the Hospital, and who was charged with investigating the Boyle Event. She averred that, in accordance with the MCARE Act, the Hospital had a patient safety plan and patient safety officer. The Hospital’s patient safety plan also established a patient safety committee pursuant to MCARE and set forth requirements for both internal and external reporting. Ms. Gallagher further stated that while she was investigating the Boyle Event in accordance with the patient safety plan, she completed both the SBAR and PSOW, which were submitted to the Hospital’s federal patient safety organization. In addition, Ms. Gallagher stated that the event was a “serious event” under the Hospital’s policy; accordingly, to comply with the MCARE Act, she created the PSRS report and submitted it to the Pennsylvania Patient Safety Reporting System. Because the event was designated a serious event, Ms. Gallagher stated that the Hospital sent a standard written disclosure confirmation to Erin Boyle regarding the event.

The Main Line Defendants also submitted an affidavit from Patricia Walsh, RN, MSN, who was working as the system manager for risk and safety at the time of the Boyle Event. Ms. Walsh explained that in order to comply with the PSQIA, the Hospital contracted for services with a federally approved patient safety organization and developed and implemented a formal patient safety evaluation system.

After the trial court issued its ruling in favor of the Boyles, the Main Line Defendants submitted a supplemental affidavit of Nurse Walsh as an attachment to their motion for reconsideration of the court’s order. In this supplemental affidavit, Nurse Walsh averred that the patient safety committee of the Hospital reviewed the Boyle Event.

We recognize that evidence that the Boyle Event was reviewed by the patient safety committee could have provided the foundation required to establish that the documents created as a result of the Boyle Event were privileged under section 311(a).

Thus, the record reflects that the Hospital had both a patient safety plan and a patient safety officer. The Hospital’s patient safety plan also established a patient safety committee pursuant to MCARE and set forth requirements for both internal and external reporting as required by sections 307(b) and 308(a). See 40 P.S. §§ 1303.307(b), 1303.308(a). The Hospital determined that the Boyle Event was a serious event and, in accordance with MCARE, sent a written notification to Erin Boyle. See 40 P.S. § 1303.308(b). Furthermore, the patient safety officer, Ms. Gallagher, created the PSRS report and submitted it to the Pennsylvania Patient Safety Reporting System. 40 P.S. § 1303.313(b). Based on our review, we conclude that the PSRS was solely prepared for the purpose of reporting under MCARE. See Ford-Bey, supra.

We next must discern whether the PSRS report arose out of a matter reviewed by a patient safety committee or a governing board pursuant to their section 311(b) responsibilities. See Lahr, supra. In the record before the trial court, neither Ms. Gallagher nor Ms. Walsh stated that the Hospital’s patient safety committee or governing board had reviewed the Boyle Event. As this Court made clear in Lahr, MCARE’s privilege applies to documents determination of whether the facts of record supported the trial court’s decision. Chrysczanavicz v. Chrysczanavicz 796 A.2d 366, 369 (Pa.Super. 2002) (explaining that document attached to party’s motion for reconsideration in trial court did not constitute entry of that document into evidence; hence document was not before this Court in evidence). Therefore, we cannot consider the supplemental affidavit of Nurse Walsh or the Main Line Defendants’ arguments relying thereon when deciding this appeal. See id.

Here, without evidence of record that the Boyle Event was reviewed by a patient safety committee or governing board, we cannot conclude that the PSRS report met the criteria for privilege under section 311(a). See id. Based on the record before the court in this case, we agree with the trial court that the Main Line Defendants did not meet their burden of establishing that the PSRS report arose out of a matter reviewed by a patient safety committee or a governing board pursuant to their section 311(b) responsibilities. As such, we affirm the trial court’s order requiring the Main Line Defendants to disclose the PSRS report.

Here, the Main Line Defendants asserted in their privilege log that the relevant documents were privileged as patient safety work product under the PSQIA generally. Notably, this is not a situation where the Main Line Defendants are asserting an entirely new theory in support of the claim that the PSOW and SBAR are privileged. Rather, the Main Line Defendants had already asserted privilege under the PSQIA generally. Hence, the Main Line Defendants provided the trial court an opportunity to consider or address whether the PSQIA privilege was applicable to the PSOW and SBAR documents under each subsection, including the “deliberations and analysis” component set forth in subsection (ii). Therefore, we conclude that this assertion was sufficient to present the trial court with the opportunity to consider the issue of whether the documents constituted patient safety work product under any of the three subsections of the PSQIA, and we decline to find waiver under these circumstances. See Pa.R.A.P. 302(a); Gustine Uniontown Assocs., Ltd., supra.

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, supra at 795 (quoting 42 U.S.C. § 299b-21(7)(B)(ii)).

Here, the Main Line Defendants introduced an affidavit from Ms. Walsh, the system manager for risk and safety at the time of the Boyle Event, who explained that the Hospital contracted with a federally approved patient safety organization and developed and implemented a formal patient safety evaluation system. (Affidavit of Patricia Walsh, RN, MSN, dated 3/29/23). In accordance with the patient safety evaluation system, Ms. Gallagher, the patient safety officer for the Hospital, created the PSOW and the SBAR. The SBAR was drafted to inform key members of the Hospital’s patient safety committee of the facts and recommendations as a result of the investigations and sent to the patient safety organization; the PSOW tracked the patient safety evaluation system investigation and noted the results of the investigation. Both documents were uploaded to the Hospital’s federal patient safety organization, ECRI PSO.

Upon review, we agree with the Main Line Defendants that these documents, produced solely in accordance with the patient safety evaluation system and reported to the patient safety organization, are a quintessential example of “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). Furthermore, there is no requirement in the PQSIA that such “deliberations and analysis,” as set forth in subsection (ii), be reported to a patient safety organization to qualify as protected “patient safety work product.”
Based upon the foregoing, we conclude that the trial court erred when it found that the SBAR and PSOW, which were created in accordance with the patient safety evaluation system, and which contained the analysis of the patient safety officer, did not constitute “patient safety work product.” Therefore, we reverse the trial court’s order finding that the PSQIA privilege did not apply. We further conclude that the Main Line Defendants met their burden of proof that the PSQIA privilege applies and hold that the burden now shifts to the Boyles “to set forth facts showing that disclosure will not violate the … privilege.” Ungurian, supra at 795.

Accordingly, we affirm in part, reverse in part, and remand to the trial court for further proceedings. Jurisdiction is relinquished. President Judge Lazarus joins the opinion. Judge Lane files a concurring/dissenting opinion.