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MEDICAL MALPRACTICE-PEER REVIEW-MCARE-SECTION 311 OF MCARE ACT

Ford-Bey v. Prof’l Anethesia Servs., 2023 Pa. Super. LEXIS 398 (September 12, 2023) (Sullivan, J.) Ms. Ford-Bey underwent wrist surgery at Hospital. Shortly after the surgery, Ms. Ford-Bey suffered cardiac and respiratory failures that required her transfer to another facility for further care. A nurse internally reported the incident pursuant to Hospital’s “Sentinel Event Policy”. Lisa Gill (“Gill”), who holds several titles at Hospital, conducted a “root cause analysis” to determine the cause of Ms. Ford-Bey’s decline. Gill took notes on a three-page form containing standard questions. The parties agree that Gill authored at least one report that she sent to the Pennsylvania Patient Safety Authority (“PPSA”), an independent agency established under the Medical Care and Reduction of Error Act (“MCARE”), 40 P.S. §§ 1303.101-1303.910. Following oral arguments, the trial court struck Hospital’s objections and on December 7, 2021, ordered Hospital to produce “any notes of Lisa Gill pertaining to the root cause analysis she conducted on June 17, 2015.” Order, 12/7/21.

Section 311 of MCARE sets forth the following confidentiality provision:

(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 313 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. . . .

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(c) Applicability.–The confidentiality protections set forth in subsection[] (a) . . . 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).

Following our review, we concur in the trial court’s conclusion that section 311(a) did not protect Gill’s notes.

MCARE requires Hospital to have in place a patient safety plan that designates a facility’s “patient safety officer,” establishes a “patient safety committee,” and identifies internal systems for employees to report serious events. Id. § 1303.307(b)(1)-(3). MCARE further requires that Hospital’s patient safety committee: (1) receives reports from the patient safety officer; (2) evaluates investigations and actions of the patient safety officer on all reports; (3) reviews and evaluates the quality of the facility’s patient safety measures; (4) makes recommendations to eliminate future serious events; and (5) reports the number of serious events and its recommendations to an administrative officer or governing body of the facility on a quarterly basis. See id. § 1303.310(b). In exchange for these policies and procedures, MCARE protects “[a]ny documents, materials or information solely prepared or created for the purpose of compliance with section 310(b) . . . 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) . . ..” Id. § 1303.311(a). Thus, for Hospital to assert a privilege under section 311(a), it bore a burden of demonstrating that Gill’s notes were exclusively prepared or created to comply with MCARE. Here, aside from Gill’s filing with the PPSA a report, which the trial court held remained confidential, Hospital failed to produce evidence demonstrating Gill solely prepared or created her notes for the purpose of complying with MCARE. To the extent Hospital relied on its Sentinel Events Policy, the Policy emanated from a Kansas corporation, and Hospital adduced no clear evidence that the Policy implemented the special requirement of an MCARE-required safety plan. See 40 P.S. § 1303.307(b). The Policy did not identify Hospital’s MCARE-required patient safety officer or patient safety committee or establish their duties with respect to “serious events.” Doyle, Hospital’s CEO and corporate designee, offered only equivocal testimony that Gill held several corporate titles, and was “possibly” Hospital’s designated MCARE patient safety officer.

Absent any clear evidence of Hospital’s compliance with maintaining the offices, committees, and procedures required Chapter 3 of MCARE, Hospital cannot demonstrate that Gill solely prepared or created her notes during the root cause analysis to comply with MCARE. Thus, Hospital did not meet their burden of invoking the privilege set forth in section 311 of MCARE.