PSA Internal Investigation Documentation

On December 21, 2022, the Pennsylvania Patient Safety Authority (PSA) issued a “Program Memorandum which announced that beginning January 2023, health care facilities such as hospitals will be required, upon request by the PSA, to provide documentation of “internal investigations” related to incidents and events that have been reported to the PSA.

The “Program Memorandum” and its mandate, will almost certainly prove to be controversial, because it identifies “internal investigation” materials to include “Root Cause Analysis, mini analyses, and Manager or Patient Safety Officer follow-up notes,” which are normally confidential materials that cannot be discovered in litigation such as medical malpractice cases. Additionally, the Memorandum provides that “investigation materials” must “at a minimum … identify the cause of the event, if known, contributing factors, and actions taken to prevent recurrence.”

The Program Memorandum claims that the provision of “internal investigation” information is “considered a required component of the PA-PSRS Report and will remain confidential.” The Memorandum further claims that the PSA’s authority to mandate production of such materials by a hospital as a “required component” of the Patient Safety Reporting System, derives from the PSA’s authority to collect data about, and oversee responses to, emerging trends of adverse events and incidents in health care.

Notably, despite the PSA’s claim that it has the power to require a hospital (or other covered facility) to produce “investigative materials” based upon its statutory mission to collect data about, and responses to, adverse medical events and incidents, the Mcare Act does not provide express statutory authority for the new requirements outlined in the PSA Program Memorandum of December 21, 2022. In fact, there is arguably no statutory provision within the Mcare Act that provides authority to the PSA to require a facility to produce otherwise confidential internal “investigative materials” related to a reported incident or event.

Specifically, § 313 of the Mcare Act (40 P.S. § 1303.313) requires facilities (such as a hospital) to report the occurrence of a serious event, incident, or infrastructure failure to the PSA in a “form and manner prescribed by the authority in consultation with the [Department of Health].” Section 313 even requires serious events and infrastructure failures to be reported within 24 hours of the event, which would naturally preclude the possibility of a complete investigation or root cause analysis to be available as part of the reporting of those occurrences. Thus, the specific language of the statutory reporting requirement mandates the report of an “occurrence of a serious event …,” but does not appear to require any additional reporting or supporting documentation, such as the cause of the event/incident, and/or any corrective measures taken. In other words, the statute does not specifically authorize the PSA to direct any hospital to produce information or materials other than to report the occurrence of an event.

All of this means that there is a significant question as to whether the PSA has the authority to order a facility to produce its otherwise confidential “investigative materials.” Of course, if a facility refuses to produce “investigative materials” it should be expected that the PSA will attempt to enforce its mandate, and thus a facility must remain cognizant that it is uncertain how a Court will decide the question of whether the PSA has the authority to require production of said materials.

Perhaps the most troubling component of the December 21, 2022 “Program Memorandum,” is the issue of confidentiality. The Program Memorandum claims that any “investigative materials” provided to the PSA will remain confidential, however, recent Court decisions raise concern that providing said materials to the PSA may not guarantee preservation of their confidentiality.

Normally, the confidentiality of a hospital’s report of a serious event pursuant to § 313 is statutorily assured, and such reports are not even subject to discovery in a subsequent lawsuit pursuant to 40 P.S. § 1303.311. However, the confidentiality provisions of § 313 apply only to documents and materials created by the facility solely for purposes of complying with the various provisions of the Mcare Act (i.e. the Event Report). Recent Court opinions have focused on the requirement that materials be generated “solely” for purposes of reporting pursuant to Mcare requirements, as a strict condition to maintain the confidentiality of said materials. Thus, to the extent that materials related to a facility’s “internal investigation” were not generated solely for purposes of (presumed confidential) Mcare reporting, then there would be a significant concern and uncertainty as to whether a court might find a waiver of confidentiality and order the production of said materials by the hospital to an interested party such as a medical malpractice plaintiff who may be suing the hospital based on the event/incident that was the subject of the (confidential) “investigation.” In such a scenario, said materials might otherwise have remained confidential and non-discoverable had they not been produced to the PSA pursuant to the Program Memorandum of December 21, 2022.

Furthermore, the disclosure of “internal investigation” materials to the PSA, even if ordered by the PSA, may also violate the requirements of federal Patient Safety laws such as the federal Patient Safety and Quality Improvement Act (42 U.S.C. § 299b-21, et seq.). Pursuant to the federal Patient Safety and Quality Improvement Act, certain materials related to “internal investigations” are not discoverable and are confidential, and may only be disclosed to third parties for certain specific reasons outlined by the federal statute. Those permitted disclosures do not include disclosures to any state Patient Safety authority. As a general rule, if a disclosure of confidential materials to a third party is not expressly authorized by the statute, said disclosure is considered a waiver of confidentiality; and the otherwise confidential materials then no longer have the confidentiality protections of the federal statute, and could be discovered by parties in litigation.

Again, this means that there is a significant question as to whether the PSA can guaranty the confidentiality of “investigative materials” it receives from a facility – – simply because disclosure to the PSA may destroy any confidentiality said materials may have enjoyed before the disclosure.

Confidentiality is at the core of all Patient Safety processes and Quality Improvement processes. Assurance of confidentiality encourages voluntary participation in the process at all levels, including reporting, follow-up critical analysis, and corrective problem solving and action. The free and confidential sharing of ideas and information in each context is essential. The PSA’s “Program Memorandum” dated December 21, 2022 raises significant concerns regarding the PSA’s authority to require disclosure of such information, and also the PSA’s ability to maintain the confidentiality of said information – – all of which could have a significant negative impact on essential hospital activities such as Root Cause Analyses, Patient Safety reporting and investigations, and Quality Improvement initiatives.

This posting is not intended to offer specific legal advice, but rather, is intended to identify issues raised by this potentially significant recent development in health care. Facilities/hospitals which are potentially impacted by the PSA’s December 21, 2022 Program Memorandum are encouraged to consult with legal counsel to further discuss the potential impact of the Program Memorandum on facility operations.