PSO Legal Update

September 10, 2015    |   By: Calevir

Cases interpreting the Patient Safety and Quality Improvement Act (PSQIA) continue to wind their way slowly through the courts. Two new Florida trial court orders have recently reinforced the strength of PSQIA protections in that state: the cases are:

Loyless v. Flagler Hospital et al., No. CA12-2401 7th Judicial Circuit, St. Johns County, FL

PETRASKIEWCHZ v. Laser Spine Institute et al., No. 13-CA-14394 13th Judicial Circuit, Hillsborough County FL (August 10, 2015)

The Loyless order is very short. The court conducted an in camera review of the documents requested by the plaintiff and held that the documents were protected PSWP. It reinforces earlier advice from CPS that participants should anticipate that a judge may want to look at the materials for which they claim protection.

The Laser Spine Institute (LSI) court produced a more extensive order that analyzes the intricacies of Florida law. Florida courts have produced some challenging decisions in the past. The opinion discusses the history of the PSQIA, including quotes from the Final Rule and Congressional Hearings leading up to the law.

Briefly, the LSI court held that 1) the PSQIA supersedes Florida’s Amendment 7 and 2) a provider can prepare PSWP separate from the mandatory state reporting system and claim PSQIA protection for its PSWP.

Highlights of the LSI case

  • The Vice President for Nursing and Surgical Services submitted an affidavit and also testified at the evidentiary hearing about the organizations Patient Safety Evaluation System (PSES) and procedures for generating PSWP. This was the key evidence that convinced the court about protections; preparation for this step is vital, as is having a sound PSES and related policies.
  • LSI initiated a separate process (“Code 15 reports”) for investigating and reporting state-reportable events as soon as they were identified within the PSES. That work proceeded independently of ongoing work inside the PSES. Only the work conducted inside the PSES generated protected PSWP. Everyone acknowledged that the Code 15 information generated outside the PSES was discoverable under the terms of the PSQIA. The opinion notes that the only information the provider was required to report to the state was an Annual Report that included aggregated and summarized information about reportable incidents, and that the Annual Report contained nothing defined by LSI as PSWP.
  • LSI had a very broad process for gathering information about adverse events, incidents and variances. The process for each type of information inside the PSES was well-defined. The information gathered at this stage was much broader than the information that must be reported under Florida law, which only includes selected serious events. The broad scope of review within the PSES seemed to influence the court, which contrasted it to the narrow reporting under state law. The court specifically noted that PSWP can be protected as soon as it is created within the PSES or reported to the PSES, and that protection does not depend on the specific data having been reported to the PSO. CPS has always recommended that participants have clear pathways for information within and outside their PSES. The LSI case reinforces the need for that clarity, and also supports the availability of PSQIA protection for work that takes place in a well-defined PSES.

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