Showing posts with label Sentinel Event Report. Show all posts
Showing posts with label Sentinel Event Report. Show all posts

Wednesday, October 18, 2023

Superior Court Addresses Discoverability of Root Cause Analysis Documents in a Medical Malpractice Case


In the case of Ford-Bey v. Professional Anesthesia Services, No. 162 EDA 2022 (Pa. Super. Sept. 12, 2023 King, J., Sullivan, J., and Stevens, P.J.E.) (Op. by Sullivan, J.), the Pennsylvania Superior Court affirmed a trial court’s discovery Order requiring a hospital to produce documents to the Plaintiff in a medical malpractice action.

According to the Opinion, this medical malpractice matter arose out of complications following a wrist surgery. The Plaintiff’s decedent eventually passed away.

During discovery, the Plaintiff requested from the hospital all data and documents from a root cause analysis that was completed following this treatment. The hospital objected based on privilege and the Plaintiff moved to strike the objections.

The hospital asserted that the materials from the root cause analysis arose out of the hospital’s performance of its MCARE obligations and that §311(a) of MCARE protected such materials from disclosures in a civil lawsuit. In support of its claim of confidentiality, the hospital provided the trial court with a copy of its Sentinel Event Policy for review. The policy established the procedures for the hospital relative to the reporting of a “Sentinel Event” and provides that the hospital will conduct a root cause analysis to determine the basic, causal factors that led to the event.  The purpose of the root cause analysis was to result in an action or improvement plan and may also result in corrective actions managed through the hospital officials.

After a review of the matter, the trial court struck the hospital’s objections and ordered the hospital to produce certain documents related to the root cause analysis that was completed. The hospital then appealed.

On appeal, the Pennsylvania Superior Court affirmed.

Initially, the court reviewed whether it had jurisdiction to decide this appeal. The court decided that it could address the merits of the claims presented.

Relative to the discoverability of the documents at issue, the court noted that Pennsylvania law imposes a shifting burden of proof in disputes when deciding whether to compel the disclosures or materials over a claim of any privilege. 

More specifically, a party asserting a privilege must initially produce facts to properly invoke the privilege. Once the privilege is properly invoked, the parties seeking disclosure bears the burden of showing that the disclosures should be compelled either because the privilege has been waived or because an exception to the privilege applies. If the party asserting the privilege produces insufficient facts to invoke the privilege, then the burden will not shift to the party seeking disclosure.

Here, it was the hospital’s claim that the trial court erred in compelling the disclosure because the evidence from its policy and the depositions of the hospital officials established that MCARE protected the documents at issue relative to the root cause analysis investigation of the Plaintiff’s treatment. The hospital argued that §311(a) confidentiality provision only requires that documents, materials, or information created or prepared by a hospital official arise out of a Patient Safety Committee’s or a Governing Board’s duties to review matters under §310(b) of the MCARE Act. The hospital asserted that the documents at issue were a manifestation of information that was solely prepared or created for the purpose of compliance with the MCARE Act.

In affirming the trial court’s rejection of the hospital’s claim of privilege, the Pennsylvania Superior Court affirmed the trial court’s reliance on the Opinion of Judge Terrence R. Nealon of the Lackawanna County Court of Common Pleas in the case of Venosh v. Henzes, 31 Pa. D.&C. 5th 411, 2013 WL 9593953 (C.P. Lacka. Co. Nealon, J.), aff’d, 105 A.3d 788 (Pa. Super. 2014) (Unpublished Memorandum).

In finding that §311(a) did not protect the hospital’s notes from disclosure in this matter, the Superior Court found in this Ford-Bey case that the Sentinel Event Policy relied upon by the hospital was not an implementation of the investigation or reporting requirements of MCARE. The court noted that the hospital’s policy did not even refer to MCARE and did not require the hospital’s Patient Safety Committee to receive reports from an investigation. Moreover, the hospital’s policy only called for the hospital’s Governing Board’s involvement in only limited circumstances.

The trial court in this matter additionally emphasized that the hospital did not establish that its Patient Safety Committee or Governing Board had in fact reviewed the documents from the root cause analysis in this matter.

The appellate court, again citing Venosh, concluded that, absent proof that a Patient Safety Committee or a Governing Board review the notes at issue, the confidentiality provisions of §311(a) did not apply.

The Pennsylvania Superior Court concurred with the trial court’s conclusion that §311(a) did not protect the hospital from having to disclose the notes at issue. The appellate court agreed that the hospital failed to produce evidence to demonstrate that the hospital official solely prepared or created her notes for the purpose of complying with MCARE. The court agreed with the trial court that the hospital did not present any clear evidence that the Sentinel event’s policy implemented the special requirement of an MCARE-required safety plan or that the Department of Health approved the Sentinel event policy as an MCARE-required safety plan.

In the end, the appellate court found no error of law or abuse of discretion in the trial court’s ruling that the hospital’s Sentinel event policy was not an implementation of the investigation or reporting requirements of MCARE or the trial court’s decision that the hospital was required to produce the documents in question in discovery.

Anyone wishing to review a copy of this decision may click this LINK.

Friday, June 19, 2015

Notable Ruling on Discoverability of Sentinel Event Reports Reconsidered

Tort Talkers may recall the recent Tort Talk blog post on Lackawanna County Judge Terrence R. Nealon’s decision in the case of Brink v. Marian Community Hospital, No. 13 - CV - 1314 (C.P. Lacka. Co. June 5, 2015 Nealon, J.), in which the court held that a Sentinel Event Report sent by the hospital to the Joint Commission was discoverable and not protected by the Peer Review Protection Act.  That Tort Talk Blog post may be viewed HERE

As an update, it is noted that the court has reconsidered its prior ruling in light of additional information having been provided by the defense such that ruling has been changed to note that the Sentinel Event Report was not discoverable under the circumstances presented.

More specifically, according to the latest ruling, defense counsel did not provide the court with the hospital's sentinel event reporting policies before.  Also, the original record submitted to the court did not prove that the Sentinel Event Report to the Joint Commission was part of a peer review process, as opposed to a voluntary report of an incident to an accreditation organization. 

The motion for reconsideration submitted by the defense provided to the court new information in the form of the hospital policies showing that the report at issue was a root cause analysis of system deficiencies, as well as an action plan recommending remedial measures, and was part of a peer review process, as opposed to a mere voluntary report of an incident. 

Accordingly, the Sentinel Event Report at issue was found to be protected from discovery under this more developed record presented to the court.

Anyone wishing to review this decision, may click this LINK.

Wednesday, April 8, 2015

Judge Nealon of Lackawanna County Addresses Novel Issue of Discovery in Medical Malpractice Case

In a recent opinion in the case of Brink v. Marian Community Hospital, No. 2013 CV 1314 (C.P. Lacka.  March 27, 2015 Nealon, J.), Judge Terrence R. Nealon addressed a discovery issue of first impression in a psychiatric malpractice case.  The issue was whether a Sentinel Event Report that is forwarded by a hospital to the private accreditation organization, The Joint Commission, is privileged and protected from discovery by Section 4 of the Peer Review Protection Act of the Medical Care Availability and Reduction of Error (MCARE) Act or the federal Patient Safety and Quality Improvement Act of 2005.

During discovery, the Plaintiff requested documentation from the hospital in terms of its accreditation and requests submitted to other entities for accreditation purposes.  The hospital acknowledged that it was in possession of a Sentinel Event Report but asserted that it was not required to produce the same in discovery.

A Sentinel Event Report is a term defined by the Joint Commission charged with accreditation of hospital and refers to the reporting of what is identified as a "Sentinel Event," i.e. a patient safety event that results in death or permanent harm to the patient.

After reviewing the matter, Judge Nealon ruled that the Report authored by the hospital was discoverable as the hospital had not established that the report was prepared or even reviewed by the hospital's peer review committee.  Also as it was apparent that the Report was not created for the purpose of complying with the MCARE's patient safety reporting requirements, and/or was not reviewed by the hospital's patient safety committee or board of trustees in compliance with their statutory duties under the MCARE Act, the Report was not protected from discovery by the MCARE Act.

The court also held that since the Report was not generated by the hospital for purposes of reporting to or by any federally recognized patient safety organization, the Report was not protected from discovery under the mandates of the federal Act.

As such, Judge Nealon ruled that the patient's estate was entitled to discovery of the Sentinel Event Report.

Anyone wishing to review this decision on this novel discovery issue may contact me at dancummins@comcast.net.