Disclosure of ‘Root Cause Analysis’

Disclosure of ‘Root Cause Analysis’

In the case of Ford-Bey v. Professional Anesthesia Services, 2023 PA Super 163, the Superior Court determined that a hospital failed to demonstrate that its investigation of a patient’s serious event was done solely to comply with the patient safety reporting requirements under the MCARE Act.

Wanetta Ford-Bey (“Ms. Ford-Bey”) suffered cardiac arrest and died shortly following wrist surgery at Physician’s Care Surgical Hospital (“Hospital”). The incident was internally reported pursuant to Hospital’s “Sentinel Event Policy” (“Policy”). The Policy provided that Hospital will conduct a root cause analysis to determine the basic, causative factor(s) that led to the event. An “administrative team” and the Hospital’s director of performance improvement determine whether an intensive assessment resulting in a root cause analysis is required, and, if so, form a team to conduct a root cause analysis. Lisa Gill (“Gill”), who held several titles at Hospital, conducted a root cause analysis to determine the cause of Ms. Ford-Bey’s decline, and took notes associated with her investigation. Gill also submitted a report 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.

During litigation, Plaintiff, Wakeem Ford-Bey (“Mr. Bey”) requested from Hospital all data and documents from the root cause analysis. Hospital objected based on privilege, arguing that the materials from the root cause analysis arose out of Hospital’s performance of its MCARE obligations, and were protected from disclosure in accordance with section 311(a) of MCARE.  Hospital’s CEO, Christopher Doyle (“Doyle”) testified that Hospital did not have a committee specifically designated a “patient safety committee,” but testified that Hospital’s Committee on Quality Initiatives (“CQI”) is the primary safety committee. Doyle described Gill’s corporate titles as “possibly” Hospital’s patient safety officer. Ultimately, the trial court ordered Hospital to produce any notes of Lisa Gill pertaining to the root cause analysis, but kept the report submitted to the PPSA confidential.

MCARE requires health care facilities 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. 40 P.S. § 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).

Under the circumstances, the Superior Court affirmed the trial court, and ruled that Hospital failed to produce evidence demonstrating Gill solely prepared or created her notes for the purpose of complying with MCARE. More specifically, the Hospital adduced no clear evidence that its Policy implemented the special requirement of an MCARE-required safety plan and did not identify Hospital’s MCARE-required patient safety officer or patient safety committee, or establish their duties with respect to “serious events.” The Hospital also failed to produce evidence that its Hospital’s CQI or any other subcommittee met the requirements of, or discharged the duties, of an MCARE patient safety committee.

Ford-Bey v. Professional Anesthesia Services, 2023 PA Super 163 can be accessed at the following link.