Pennsylvania Appellate Court Affirms Hospital Must Disclose Root Cause Analysis Notes Regarding Patient’s Bad Surgical Outcome

Wanetta Ford-Bey underwent wrist surgery at the defendant hospital. Shortly after the surgery, she 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” (“Policy”). Lisa Gill (“Gill”), who holds several titles at the hospital, conducted a “root cause analysis” to determine the cause of Ms. Ford-Bey’s decline. Gill interviewed Hospital staff members involved in Ms. Ford-Bey’s surgery and care. Gill took notes on a three-page form containing standard questions. The parties agreed 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.

Ms. Ford-Bey remained in a vegetative state after the surgery and died in July 2015. Her Estate filed a Pennsylvania medical malpractice action against the hospital and several other defendants. During discovery, the Estate requested
from the hospital all data and documents from the root cause analysis. The hospital objected based on privilege, arguing that materials from the root cause analysis arose out of the hospital’s performance of its MCARE obligations and that section 311(a) of MCARE protected such materials from disclosure in a civil proceeding. The trial court ordered the hospital to produce “any notes of Lisa Gill pertaining to the root cause analysis she conducted on June 17, 2015.” The hospital appealed.

The Superior Court of Pennsylvania (“Pennsylvania Appellate Court”) stated in its September 12, 2023 Opinion: “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).”

“While Hospital focuses on the phrase “which arise out of matters reviewed,” the critical term, here, is “solely.” That is, section 311(a) confidentiality attaches to “documents, materials or information solely prepared or created for the purpose of compliance” with the relevant MCARE requirements. Id. (emphasis added). “Solely” means “without another or others,” or “only, exclusively, merely, or altogether.” Webster New World College Dictionary (4th Ed.) at 1364 (2002). 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.””

The Pennsylvania Appellate Court held: “we discern no error of law or abuse of discretion in the trial court’s ruling that Hospital’s Sentinel Event Policy was “clearly not an implementation of the investigation or reporting requirements” of MCARE. See Trial Court Opinion, 3/23/22, at 16. Absent any clear evidence of Hospital’s compliance with maintaining the offices, committees, and procedures required [by] 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, and the burden did not shift to Appellee to demonstrate waiver or an exception to the statute. For these reasons, we agree with the trial court that the MCARE privilege did not apply, and we affirm its order compelling disclosure of Gill’s notes.”

Source Ford-Bey v. Professional Anesthesia Services, 2023 PA Super 163.

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