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December 8th, 2022
Twenty-three infants, including Plaintiffs’ decedents, contracted an adenovirus in CHOP’s NICU. CHOP’s Infection Prevention & Control (“IP&C”) Department 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.
Dr. Sammons discovered that the common event experienced by all infected babies was a retinopathy of prematurity (“ROP”) eye examination. A hand-held lens and an indirect ophthalmoscope revealed the presence of the adenovirus. Dr. Sammons concluded that the virus was transmitted to each of the patients by the doctor touching the contaminated equipment and then touching the babies. 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, Dr. Sammons participated in a meeting with the Patient Safety Committee, and 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. The meetings involved the sharing of information, the evaluation of professional health care provider conduct, the quality of patient safety measures, and recommendations for new or modified patient safety methods, but were often held outside the Patient Safety Committee.
Dr. Sammons also 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. PowerPoint slides were also given to CHOP’s Patient Safety Committee. CHOP also reviewed PowerPoint slides during several Morbidity and Mortality (“M&M”) conferences related to the outbreak.
Moreover, 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.”
Finally, 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.
CHOP objected to the production of the above referenced materials on the basis of confidentiality provision set forth in the PRPA, 63 P.S. § 425.4, and MCARE Act, 40 P.S. § 1303.311. The trial court determined the materials were not privileged, and CHOP appealed. The Superior Court made the following conclusions:
The RCA Report was not protected by the PRPA because CHOP failed to establish the members of the root cause analysis team were “professional health care providers;” however, it was protected by the MCARE Act because it 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.
The “Safety Huddle” and Patient Safety Committee PowerPoint Slides were protected by the MCARE Act because they 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. The Court also determined that while some of the information contained in the Power Point slides was disclosed by third-parties, the document privilege was not waived.
The “M&M” PowerPoint Slides were not protected by the MCARE Act because they did not arise out of matters reviewed by the patient safety committee; however, they were protected by the PRPA because the conferences were attended solely by professional health care providers, and the materials were 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.
The IP&C PowerPoint Slides and meeting minutes were also protected by the MCARE Act as the IP&C Committee was a peer review sub-committee of the Patient Safety Committee that conducts investigations and reports to the Patient Safety Committee. Furthermore, § 310(b) of the MCARE Act tasks a patient safety committee with, inter alia, evaluating investigations directed by the patient safety officer, reviewing and evaluating the quality of the hospital’s patient safety measures, and making recommendations to eliminate future serious events. See 40 P.S. § 1303.310(b)(2)-(4). Her, the purpose of the meetings was to evaluate the ophthalmologists’ practice, the outbreak response, and compliance with CHOP procedures, as well as to discuss steps to improve healthcare quality and patient safety in the future, which falls squarely within responsibilities of the Patient Safety Committee.
Interestingly, CHOP also withheld “Intranet postings” to CHOP personnel about the outbreak, which the Court determined was not protected by MCARE because the purpose of the posts was to notify CHOP personnel of events to increase awareness, encourage learning from events, and to recommend actions to prevent serious events or incidents, as opposed to compliance with the MCARE Act.
Finally, the CHOP produced redacted ophthalmology emails arguing that the redacted information was protected by the MCARE Act and PRPA because it referenced action plans part of the peer review process and taken under MCARE precautions. The Court concluded there was no evidence that the emails were made pursuant to a peer review evaluation or in furtherance of MCARE reporting.
