Courts Produce More Good News for PSOs

The patient safety work product privilege is a quiet corner of the room ... The statutes carve an exception to the presumption of free and open disclosure to facilitate a specific, carefully designed process of disclosure. If they are cautious to remain within the confines of the patient safety evaluation system (PSES), medical professionals may provide the brutally honest feedback hospitals need to keep their patients safe without fear of its use in litigation. (Rumsey v Guthrie) [i]

This artful description of a PSO by a Pennsylvania federal court appears in a recent decision -- one of the first to recognize the full potential of the Patient Safety and Quality Improvement Act (PSQIA). The plaintiff filed suit as a result of a MRSA infection that developed after an elective procedure. In discovery, he requested several items that were part of the defendant's routine quality and safety work, including documents related to quality committee meetings that addressed infection protection or infection control. The court’s response protected the privilege for those things: 

“This is the quintessential example of patient safety work product privilege. Quality committee meetings are a core aspect of Guthrie’s patient safety evaluation system. Agendas, notes, and other written records from these meetings are squarely work product and are ‘deliberations or analysis of’ a patient safety evaluation system.”

Underscoring the importance of the Rumsey case.
The court also refused to allow deposition “questions regarding subjects such as Guthrie’s quality committee meetings, how the committee determined infection preparedness, the data used to reach preparedness conclusions, and why they collected certain data and not others. These questions seek information generated by the patient safety evaluation system, and I will not order the parties to reopen the deposition to have them answered.”

The case is important for two reasons. First, it is the first to uphold the protection of “deliberations and analysis clearly,” a category clearly outlined in the PSQIA.  Second, it underscores the availability of protection for an organization’s routine safety and quality work, so long as the PSQIA requirements are met.  The opinion contains a clear and supportive interpretation of the statute, the final regulation, and the agency comments -- one which has been attacked by the plaintiff’s bar over the years.

CPS welcomes the Rumsey case and other legal interpretations, which support the advice we have given our clients over the years. 

Here are the basics:

• The federal law supersedes state law, even state constitutional provisions.[ii]
• The law protects all information submitted to a PSO from discovery directed at the PSO. Efforts to gather it from the PSO will not be successful.
• If the provider meets all requirements of the law, the information in the provider’s hands will be protected if:
  • The provider must have an ongoing relationship with a PSO.
  • Only material developed as part of a Patient Safety Evaluation System (PSES) can be protected. A PSES is a work space for patient safety activities. Defining a PSES is an essential first step in PSO participation. Courts have exhibited great skepticism about after-the-fact efforts to claim that work took place in a PSES.  Conversely, they have been quite willing to accept providers’ clear definitions of a PSES, especially when evidence points to the PSES’ ongoing operation within the defined boundaries (the “quiet corner of the room”).
  • The statute’s definitions of protected information rely on reporting information to the PSO, so the provider must report something. The stronger the nexus between the reported information and the material to be protected, the better. For example, if a provider only reports about falls, it may be difficult to protect internal work product about medication errors.

• The protections can extend beyond reported materials in two ways:
  • Functional reporting protects materials related to actual reported information. For example, when a PSO participant submits an event using common formats, the materials required to identify and analyze that report can be protected if they otherwise qualify as patient safety work product (PSWP).
  • Materials and activity that reflect the deliberations and analysis within the PSES are automatically protected, so long as there is some nexus between the actual reports and the work. This provision can protect the deep-dive work into specific patient safety issues.[iii]
• The law presumes that the work in the PSES constitutes the patient safety analysis and improvement activity of the organization. Quality and safety committees can do their work inside the PSES, so long as there is a nexus to reporting. The fact that the work also benefits the organization won’t disqualify its protected status.
• Information developed for purposes other than internal patient safety and quality improvement probably can’t be protected. CPS often fields questions about this requirement in the context of human resources work, peer review, and mandatory reporting of events to outside organizations or the state. These are subtle issues, and providers should work through them with their PSOs and their attorneys. 
• Some have argued that only material developed exclusively for reporting to the PSO can be protected. The Agency for Healthcare Research and Quality (AHRQ) issued an advisory, non-binding paper several years ago that seemed to support this premise. That interpretation would only allow a PSES to develop information for reporting to the PSO, not for internal benefit. 

Clarifying the vital role of Patient Safety Organizations.
The last point, sometimes referred to as the “sole purpose” requirement, has created confusion over the last few years. However, courts interpreting the PSQIA have determined that normal patient safety and quality improvement activities can still be protected by the PSQIA if conducted inside a defined PSES.

The Center for Patient Safety assists its participants as they work through these issues, both setting up their PSES and establishing compliant workflows.  If your organization would like to explore participation with CPS’ PSO, contact us at info@centerforpatientsafety.org.

[i] RICHARD RUMSEY v. GUTHRIE MEDICAL GROUP, P.C., No. 4:18-CV-01605 (M.D. Pa 2019).  Accessible at:

https://www.casemine.com/judgement/us/5d92ebb1342cca5116ca5e34

[ii] FLORIDA HEALTH SCIENCES CENTER, INC. d/b/a TAMPA GENERAL HOSPITAL v. AZAR, Case No. 8:18-cv-238-T-30CPT (U.S. Dist. Ct., Tampa Div. 2019)

[iii] RUMSEY, supra; DALEY v. Ingalls, 2018ILApp (lst) 170891 (2018)