Chapter 3 of the MCARE Act relates to patient safety and was enacted to reduce medical errors for the purpose of ensuring patient safety. 40 P.S. § 1303.301. Chapter 3 requires medical facilities to develop, implement, and comply with a patient safety plan and establish internal reporting systems for healthcare workers to report incidents and serious events. 40 P.S. §§ 1303.307(b)(3), 1303.308(a). The patient safety plan must also designate a patient safety officer and establish a patient safety committee. 40 P.S. at § 1303.307(b)(1)-(2).
Section 310(b) of the MCARE Act requires the patient safety committee to:
(1) receive reports from the patient safety officer.
(2) evaluate the patient safety officer’s investigations and actions on all reports.
(3) review and evaluate the quality of patient safety measures utilized by the medical facility, which must include consideration of reports made under sections 304(a)(5) and (b), 307(b)(3) and 308(a).
(4) make recommendations to eliminate future serious events and incidents.
(5) give quarterly reports to the administrative officer and governing body of the medical facility about the number of
serious events and incidents and the committee’s recommendations to eliminate future serious events and incidents.
40 P.S. § 1303.310(b). The Hospital must also report all incidents to the Pennsylvania Patient Safety Authority (“PPSA”). 40 P.S. § 1303.313(b).
In addition to the requirements for reporting, the General Assembly created a corresponding confidentiality section in the MCARE Act which provides as follows:
§ 1303.311. Confidentiality and compliance
(a) Prepared materials.–Any documents, materials or information solely prepared or created for the purpose of
compliance with section 310(b) or of reporting under section 304(a)(5) or (b), 306(a)(2) or (3), 307(b)(3), 308(a),
309(4), 310(b)(5) or 3131 which arise out of matters reviewed by the patient safety committee pursuant to section 310(b) or the governing board of a medical facility pursuant to section 310(b) are confidential and shall not be
discoverable or admissible as evidence in any civil or administrative action or proceeding. Any documents, materials, records or information that would otherwise be available from original sources shall not be construed as immune from discovery or use in any civil or administrative action or proceeding merely because they were presented to the patient safety committee or governing board of a medical facility.
(b) Meetings.–No person who performs responsibilities for or participates in meetings of the patient safety committee
or governing board of a medical facility pursuant to section 310(b) shall be allowed to testify as to any matters within
the knowledge gained by the person’s responsibilities or participation on the patient safety committee or governing
board of a medical facility, 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 pursuant to section 310(b).
(c) Applicability.–The confidentiality protections set forth in subsections (a) and (b) shall only apply 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 set forth in section 310(b).
(d) Received materials.–Except as set forth in subsection (f), any documents, materials or information received by the
authority or department from the medical facility, health care worker, patient safety committee or governing board of a medical facility solely prepared or created for the purpose of compliance with section 310(b) or of reporting under section 304(a)(5) or (b), 306(a)(2) or (3), 307(b)(3), 308(a), 309(4), 310(b)(5) or 313 shall not be discoverable or admissible as evidence in any civil or administrative action or proceeding. Any records received by the authority
or department from the medical facility, health care worker, patient safety committee or governing board of a medical
facility pursuant to the requirements of this act shall not be discoverable from the department or the authority in any
civil or administrative action or proceeding. Documents, materials, records or information may be used by the
authority or department to comply with the reporting requirements under subsection (f) and section 304(a)(7) or
(c) or 306(b).
40 P.S. § 1303.311(a)-(d).
The Superior Court of Pennsylvania stated in its September 10, 2025 Opinion in a case it was deciding: “[T]he 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 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.”
Nonetheless, “MCARE’s privilege applies to documents solely created for compliance with MCARE, only when the documents arose out of matters reviewed by a patient safety committee or governing board. Lahr, supra at *8. 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 [Patient Safety Reporting System] report.” (emphasis added)
Next, “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’” … 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.””
Source Boyle v. Main Line Health, Inc., 2025 PA Super 199.
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