MEDICAL MALPRACTICE-PEER REVIEW-MCARE

December 1st, 2022 by Rieders Travis in Medical Malpractice

Sanders v. Children’s Hosp. of Phila., 2022 Pa. Super. LEXIS 462 (November 22, 2022) (Bowes, J.) Before us are three consolidated interlocutory appeals from orders which, inter alia, overruled the privilege objections of Children’s Hospital of Philadelphia (“CHOP”) to the discovery requests of the appellees (collectively “Plaintiffs”), who are the parents and estate administrators of three infants who died after contracting an adenovirus in CHOP’s neonatal intensive care unit (“NICU”). We affirm in part, reverse in part, and remand for further proceedings consistent with this opinion.

Twenty-three infants, including Plaintiffs’ decedents, contracted an adenovirus in CHOP’s NICU in the late summer of 2016. CHOP’s Infection Prevention & Control (“IP&C”) Department became aware of the cluster of adenovirus cases on August 22, 2016. It therefore began an investigation pursuant to CHOP’s IP&C Plan “to find the cause and stop the outbreak,” led by Dr. Julia Sammons, CHOP’s attending infectious disease physician, chair of the IP&C Committee, and a member of CHOP’s Patient Safety Committee. Dr. Sammons reported to Dr. Jan Boswinkel, CHOP’s designated Patient Safety Officer pursuant to the Medical Care Availability and Reduction of Error (“MCARE”) Act, 40 P.S. §§ 1303.101-1303.910.

The fruits of the investigation were as follows. Dr. Sammons discovered that the common event experienced by all infected babies was a retinopathy of prematurity (“ROP”) eye examination.  Subsequent testing of the equipment used in the examinations, namely a hand-held lens and an indirect ophthalmoscope that never came in contact with the patients, revealed the presence of the adenovirus.  After observing the physicians perform ROP examinations, Dr. Sammons ultimately concluded that the virus was transmitted to each of the patients by the doctor touching the contaminated equipment and then touching the babies.  Accordingly, while CHOP had no hand hygiene or equipment-specific cleaning policies for ROP examinations prior to the outbreak, CHOP instituted both hand hygiene protocols and required bleach cleaning of the equipment as a result of the investigation.

In the process of gathering the information to make the above discoveries, conclusions, and recommendations, the following meetings occurred. Dr. Sammons reported to the Patient Safety Committee on August 25, 2016, regarding the investigation to date. The Committee requested that Dr. Sammons persist with her efforts and continue to provide updates. Between August 24 and September 6, 2016, Dr. Sammons periodically held “safety huddles” with members of the IP&C Department and with doctors and nurses in the NICU, involving the sharing of PowerPoint slides on August 24, 25, 29, 30, and 31, as well as September 2, and 6, 2016.  While these safety huddles were “frequently coordinated with the Patient Safety Officer,” many of these meetings “were impromptu ad hoc meetings” outside of the established Patient Safety Committee meetings for the collection and review of data.  In addition to the sharing of information, the meetings involved the evaluation of the actions of professional health care providers, the quality of patient safety measures, and recommendations for new or modified patient safety methods.

On September 14 and October 12, 2016, Dr. Sammons and other members of the IP&C Department reported to the IP&C Committee, utilizing PowerPoint slides. These presentations involved the evaluation of IP&C and NICU providers, discussions of possible improvements to health care quality, and suggestions for new procedures and the monitoring of compliance therewith.  A similar presentation, also including PowerPoint slides, was given to CHOP’s Patient Safety Committee on September 22, 2016.

CHOP held several Morbidity and Mortality (“M&M”) conferences related to the outbreak. Specifically, on September 26, 2016, Dr. Sammons and other doctors, utilizing PowerPoint slides, presented a Patient Safety M&M at Dr. Boswinkel’s request as a subcommittee of the Patient Safety Committee.  On October 4, 2016, PowerPoint presentations were made in furtherance of “peer review and improving the quality of health care” to professional health care providers at NICU and Ophthalmology M&M conferences “to evaluate the services performed by other professional health care providers, conduct practice analysis, and recommend improvements for . . . services provided to CHOP patients.”  Similar programs, with slides, were presented at CHOP Ophthalmology Residents and Surgical Division Chiefs M&M conferences on October 10 and 11, 2016, respectively, as well as at the University of Pennsylvania’s Scheie Eye Institute’s M&M Grand Rounds Conference on January 17, 2017.

In the meantime, CHOP’s Patient Safety Committee directed a formal root cause analysis (“RCA”) of the outbreak which resulted in an RCA report. That report, which was submitted to the Patient Safety Committee, summarized the gathering and evaluation of the information about the outbreak and proposed a plan for preventing another one.  The RCA report was presented to the Patient Safety Committee at its November 17, 2016 meeting.

Believing that the transmission of the virus through ophthalmology equipment that does not come into direct contact with the patient was a novel finding, Dr. Sammons also published an abstract and article about the outbreak. Neither utilized any of the documents created during the course of the investigation, but referenced the facts of the outbreak. Additionally, one month after the outbreak, Dr. Monte Mills, the chief of CHOP’s Ophthalmology Division, and Dr. Albert Maguire, an ophthalmologist who was not part of the NICU treating team, exchanged emails concerning Dr. Maguire’s desire to discuss the finding of the investigation in a paper. The subject of the email was “NICU consult hygiene/infection control.”

In December 2017 and August 2018, Plaintiffs filed survival and wrongful death actions against CHOP alleging medical malpractice. Specifically, Plaintiffs contended that CHOP was negligent in failing to follow proper procedures for disinfecting the ophthalmology equipment. During the course of discovery, Plaintiffs issued discovery requests to which the above-identified documents were responsive. CHOP compiled a privilege log identifying the documents and asserting privilege. CHOP also produced affidavits from Drs. Sammons and Boswinkel asserting that the documents at issue were created at the behest of CHOP’s Patient Safety Committee and Officer for purposes of complying with its obligations pursuant to the MCARE Act and “to conduct peer review.”

It is well-settled that evidentiary privileges are disfavored, and that their use should be permitted “only to the very limited extent that excluding relevant evidence has a public good transcending the normally predominant principle of utilizing all rational means for ascertaining the truth.” BouSamra v. Excela Health, 653 Pa. 365, 210 A.3d 967, 975 (Pa. 2019) (cleaned up). Regarding the respective duties of the parties when a privilege is invoked, we have observed that “[t]he party invoking a privilege must initially set forth facts showing that the privilege has been properly invoked.” Yocabet v. UPMC Presbyterian, 2015 PA Super 132, 119 A.3d 1012, 1019 (Pa.Super. 2015) (cleaned up). “Once the invoking party has made the appropriate proffer, then the burden shifts to the party seeking disclosure to set forth facts showing that disclosure should be compelled either because the privilege has been waived or because an exception to the privilege applies.”

In other words, the scope of the privilege afforded by the PRPA “is limited to documents of a review committee that it utilized when it engaged in peer review.”  As such, the PRPA offers privilege only to materials prepared in furtherance of “(i) evaluating and improving the quality of health care rendered; (ii) reducing morbidity or mortality; or (iii) establishing and enforcing guidelines designed to keep within reasonable bounds the cost of health care.” 63 P.S. § 425.2.

Since a patient safety committee organized pursuant to § 310(a)(1) of the MCARE Act includes members of the community that are not professional health care providers, the patient safety committee cannot constitute a peer review committee whose proceedings are protected by the PRPA. See Ungurian v. Beyzman, 2020 PA Super 105, 232 A.3d 786, 800 (Pa.Super. 2020) (“Because the Patient Safety Committee includes members of the community served by Hospital, the Committee is not exclusively comprised of ‘professional healthcare providers.’ Accordingly, Hospital failed to satisfy its evidentiary burden of proving the applicability of the PRPA privilege to the Patient Safety Committee Meeting Minutes.”). Instead, the MCARE Act contains a separate confidentiality provision.

Hence, to be privileged pursuant to the MCARE Act, the materials must: (1) be solely prepared for compliance with an enumerated MCARE Act duty, (2) arise out of matters reviewed by the patient safety committee in accordance with § 310(b), and (3) not be otherwise available from original sources. See 40 P.S. § 1303.311(a)See also Venosh v. Henzes, 11 CV 3058, 2013 Pa. Dist. & Cnty. Dec. LEXIS 390, 2013 WL 9593953 (Lackawanna County C.C.P. July 17, 2013)aff’d105 A.3d 788 (Pa.Super. 2014) (unpublished memorandum) (gleaning from the plain language of § 311 the foregoing three requirements for MCARE Act confidentiality to apply).

The Root Cause Analysis Report

Plaintiffs rightly argue in their brief that the root cause analysis report was not protected by the PRPA. We agree that CHOP did not establish that the PRPA privilege attached to the root cause analysis. See Ungurian v. Beyzman, 2020 PA Super 105, 232 A.3d 786, 798 (Pa.Super. 2020) (concluding that the hospital’s failure to establish that the members of the root cause analysis team were “professional healthcare providers” defeated a claim of PRPA privilege).  The evidence of record detailed above demonstrates that CHOP met its burden of establishing that the root cause analysis report was (1) solely prepared for compliance with the MCARE Act duties for the Patient Safety Officer to report, and the Patient Safety Committee to receive, accounts of investigations into serious events and suggestions to improve patient safety; (2) arose out of matters that were indeed reviewed by the patient safety committee in accordance with § 310(b); and (3) was not otherwise available from original sources. See 40 P.S. § 1303.311(a). Therefore, pursuant to § 311(a), the root cause analysis document prepared for compliance with § 310(b) is itself subject to the privilege. Thus, we reverse the portion of the trial court’s order directing CHOP to produce the root cause analysis report.

PowerPoint Slides

We first observe that the statutory privileges are not waived or otherwise invalidated by the fact that details of how the outbreak occurred and the measures that were ultimately implemented to reduce the risk of future outbreaks may have been disclosed in a published article and abstract. See Dodson, supra at 1244 (explaining that a privileged document does not become discoverable “simply because some of the information contained therein is available elsewhere”).

Both the PRPA and the MCARE Act include varying protections for both documents and information, and provide, absolutely and without exception, that the protected materials shall not be discoverable or admissible, and that no one is permitted to testify in a civil action about protected information such as testimony before a committee or opinions formed as a result of committee meetings. See 63 P.S. § 425.440 P.S. § 1303.311(a)(b). Both statutes, however, allow for the disclosure by committee members of information within their personal knowledge gleaned outside of their participation in the confidential proceedings.

Our prior discussion of the law indicates that both statutory privileges were designed to foster the frank and open discussion of the quality of health care services provided without fear that such will be used against the hospital or other professional health care providers in litigation. However, the disfavor with which evidentiary privileges are viewed remains. Thus, our legislature carefully chose language to establish that, while the facts and information independently brought into confidential meetings and investigations may be discoverable, the documents created for and proceedings themselves are what is privileged.

These documents were not some form of incident reports or other mere business records designed to document the occurrences for future litigation or risk management. See Atkins v. Pottstown Mem’l Med. Ctr., 430 Pa. Super. 279, 634 A.2d 258, 260 (Pa.Super. 1993) (holding incident report prepared for risk manager was an unprivileged business record because it was not part of an evaluation or review by a peer review committee); Venosh, supra 2013 Pa. Dist. & Cnty. Dec. LEXIS 390, [WL] at *11 (holding event reports were not privileged where there was no evidence that they were generated to comply with an MCARE patient safety reporting requirement or ever reviewed by the patient safety committee). Rather, the evidence produced by CHOP established that the documents were (1) solely prepared for compliance with the MCARE Act duties for the Patient Safety Officer to conduct investigations into serious events and suggestions to improve patient safety; (2) arose out of matters that were indeed reviewed by the patient safety committee in accordance with § 310(b); and (3) were not otherwise available from original sources. See 40 P.S. § 1303.311(a). Accordingly, we reverse the trial court’s order to the extent that it compelled production of the slides.

The PowerPoint slides prepared following the completion of the investigation for presentation at the formal Patient Safety Committee Meeting conducted on September 22, 2016, and the Safety M&M conference on September 26, 2016, are confidential materials pursuant to §§ 310(b) and 311 of the MCARE Act.  We therefore reverse the trial court’s order insofar as it requires CHOP to produce the documents.

Finally, we consider the PowerPoint slides prepared for the other M&M conferences held at CHOP and the Scheie Eye Institute Grand Rounds Conference.

We agree with CHOP that it produced evidence to show that these documents fell squarely within the protections of § 425.2 of the PRPA. As noted above, that section extends privilege to materials prepared for “(i) evaluating and improving the quality of health care rendered; (ii) reducing morbidity or mortality; or (iii) establishing and enforcing guidelines designed to keep within reasonable bounds the cost of health care.” 63 P.S. § 425.2. Contrary to Plaintiffs’ assertions, Dr. Sammons’s affidavit expressly indicates that each of the conferences was attended exclusively by professional health care providers and that the “slides were intended only for purposes of conducting peer review and improving the quality of health care.”

Indeed, morbidity and mortality conferences attended solely by professional health care providers are precisely the peer review actions that the PRPA was designed to encourage. As CHOP notes, one court recently observed that to find that M&M materials were not protected by the PHRA “would contravene the precise purpose for which [the PRPA’s] protections were enacted.” Quoting Morrissey v. Geisinger Cmty. Med. Ctr., 3:19-CV-894, 2020 U.S. Dist. LEXIS 219391, 2020 WL 6877183, at *3 (M.D. Pa. Nov. 23, 2020)). See also Bridenstine v. Saint Francis Hosp. & Med. Ctr., 142 Conn. App. 850, 68 A.3d 127, 133 (Conn. App. 2013) (affirming trial court ruling based upon its finding that the happenings at an M&M conference were subject to peer review privilege). Therefore, we reverse the trial court’s direction for CHOP to produce the documents.

PowerPoint Slides and Minutes from IP&C Committee meetings on September 14 and October 12, 2016

The trial court considered together Dr. Sammons’s PowerPoint slides presented at IP&C Committee meetings and the resultant meeting minutes.

The affidavit and deposition testimony of Dr. Sammons provides that the IP&C Committee is a peer review sub-committee of the Patient Safety Committee that conducts investigations and reports to the Patient Safety Committee. Dr. Sammons prepared slides to present at meetings to assist it in “evaluating the outbreak response by Infection Prevention providers and NICU providers, evaluated the ophthalmologists’ practices, discussed monitoring of compliance with policies and procedures and evaluated next steps to prevent recurrence.” The Committee further discussed its upcoming reports to the Patient Safety Committee.

We reverse the trial court’s order to the extent that it mandated production of the documents.

PowerPoint slides from the Patient Safety Committee meeting on September 22, 2016

The next document at issue involves the slides Dr. Sammons presented at the Patient Safety Committee meeting that the IP&C Committee discussed in the documents we just reviewed. CHOP again asserts MCARE Act privilege, and Plaintiffs again contend that the slides were part of the response rather than a review of the hospital’s response.  For the reasons offered above, we conclude that CHOP established that the documents were utilized in the report to the Patient Safety Committee in accordance with § 310(d) of the MCARE Act and are consequently protected by § 311(a). Hence, we reverse the trial court’s order to the extent that it mandated production of the documents.

Intranet postings to CHOP personnel about the outbreak

The next documents at issue identified in CHOP’s privilege log were two postings on CHOP’s intranet website: one in August 2016 entitled “CHOP Serious Safety Events” and one in February 2017 entitled “Learning from our Safety Events.”

The MCARE Act does not protect any and all materials involving patient safety. Rather, it addresses in §§ 309 and 310(d) reports to the patient safety committee and the committee’s internal deliberations about what occurred and what altered policies might better serve patient safety. CHOP points to nothing within the MCARE Act that protects subsequent communications from the patient safety committee to the institution at large announcing the new policies decided upon as a result of their confidential proceedings. We discern no provision of the Act that expresses an intention to forever shield from discovery hospital policies that arose from patient safety committee meetings. Rather, it seeks to protect the confidentiality of the investigation and assessment of the serious events that occasioned the policies.  CHOP has failed to establish that the trial court committed an error of law in ordering the production of the intranet posts.

Redacted ophthalmology emails

CHOP argues that the trial court erred in ordering the full disclosure of what it describes as “redacted ophthalmology emails.  CHOP failed to meet its burden of establishing that these emails were privileged communications within CHOP’s peer review or patient safety apparatus.

Concussion

We understand that Plaintiffs have the ultimate burden of proving that their heartbreaking losses resulted from CHOP’s negligence, and that accessing the documents at issue would lighten that burden. However, our legislature has recognized that the public has a competing, compelling interest in creating an environment in which improving the quality of health care by examining and learning from past incidents is not eschewed for fear that the honest assessment thereof could be used against health care providers to impose legal liability.

Attorney Cliff Rieders

Attorney Cliff RiedersCliff Rieders is a Nationally Board Certified Trial Lawyer practicing personal injury law. A large part of his practice involves multi-district litigation, including cases related to pharmaceuticals, vitamin supplements and medical devices. He is admitted in several state and federal courts, as well as the Supreme Court of the United States. Rieders is the past regional president of the Federal Bar Association and is a life member of the distinguished American Law Institute, which promulgates proposed rules adopted by many state courts. He is a past president of the Pennsylvania Association for Justice, formerly Pennsylvania Trial Lawyers Association. As a founder of the Pennsylvania Patient Safety Authority, he served on the Board for 15 years.

Not only has Rieders held many highly esteemed, leadership positions, he authored legislation related to the Patient Safety Authority and the Mcare Act, which governs medical and hospital liability actions in Pennsylvania. He authored texts upon which both practitioners and judges rely, including Pennsylvania Malpractice Laws and Forms, and Financial Responsibility Law Issues in Pennsylvania, the latter governing auto and truck collisions in Pennsylvania. In addition, he wrote several books on the practice of law in Pennsylvania regarding wrongful death and survivor actions, insurance bad faith, legal malpractice claims and worker rights, among others. Rieders also serves as a resource to practitioners as a regular speaker for Celesq, an arm of the world’s largest legal publisher, Thomson Reuters West Publishing.

As recognition of his wide range of contribution to his profession and of his dedication to protecting the rights of his clients, he received numerous awards, among them the George F. Douglas Amicus Curiae Award, the Milton D. Rosenberg Award, the B’nai B’rith Justice Award, and awards of recognition from the Pennsylvania Trial Lawyers. [ Attorney Bio ]

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