On May 29 an Illinois appellate court upheld a lower court’s decision that patient safety work product (PSWP) is privileged and not subject to discovery under the 2005 Patient Safety and Quality Improvement Act (PSQIA).
Illinois Department of Financial and Professional Regulation (IDFPR) v. Walgreen, Company, 2012 IL App (2d) 110452, No. 2-11-0452 (May 29, 2012)
- The IDFPR subpoenaed “all incident reports of medication error” involving certain Walgreen pharmacists.
- Walgreens asserted these materials were submitted to its Patient Safety Organization (PSO) and therefore part of PSWP and not subject to discovery rules under the PSQIA.
- IDFPR sued Walgreens, arguing that the documents were retained for purposes other than reporting to a PSO, and thus not protected.
- The lower court dismissed IDFPR’s petition and declared the incident reports to be PSWP, as defined by Walgreen’s PSO policies; IDFPR appealed.
The Illinois appeals court’s decision in favor of Walgreens is based on two provisions of the PSQIA…
- The purpose of the PSQIA is to encourage “a culture of safety” and quality in the U.S. healthcare system by “providing for broad confidentiality and legal protections of information collected and reported voluntarily for the purposes of improving the quality of medical care and patient safety.”
- PSWP is defined as “any data, reports, records, memoranda, analyses, or written or oral statements which are assembled or developed by a provider for reporting to a PSO and are reported to a PSO, and that information collected, maintained, or developed separately, or that exists separately, from a patient safety evaluation system is not considered PSWP.”
In making its decision, the appeals court determined that two affidavits prepared by Walgreens clearly satisfied the requirements of the PSQIA, resulting in protection for the subpoenaed documents.
The court cited the broad language of the PSQIA in protecting PSWP from discovery in connection with a federal, state, or local civil, criminal, or administrative proceeding. In so ruling, the court applied the broad federal protections provided under the PSQIA.
What Does This Mean for Health Care Providers?
- The ruling recognizes the intent of the PSQIA to establish a “culture of safety” to encourage reporting of medical errors for the purpose of learning and improvement.
- It reinforces the value of participating in a PSO to secure protection of PSWP generated for the purpose of improvement.
- This state court ruling applies the federal PSQIA protections more broadly than the state privilege laws, highlighting the opportunity for PSQIA protections to fill gaps in state peer review law protections.
- Licensed health care providers, such as hospitals, physicians, emergency medical services, ambulatory centers, nursing homes, and pharmacies can take advantage of the discovery privilege by contracting with a PSO, establishing a Patient Safety Evaluation System (PSES), collecting and submitting documents, data, evaluations and conducting other protected activities.
The court ruling further reinforces the recommendations for PSO participants to ensure maximum protection:
- Carefully review policies to ensure the PSES and PSWP are clearly defined
- Segregate and secure PSWP
- Clearly label PSWP to prevent unauthorized disclosure
- Submit PSWP to the PSO with appropriate documentation (automatically done by the MOCPS PSO data system)Establish a process to evaluate and manage requests for PSWP from organizations and individuals outside of your organization’s defined “workforce”.
The Missouri Center for Patient Safety (MOCPS) is certified as a federally-designated Patient Safety Organization (PSO), positioned to assist new and current participants to obtain the valuable protections available within the PSQIA – and, mostly importantly to prevent patient harm. PSO data is collected and analyzed in a protected environment allowing honest disclosure and discussion to learn about adverse events, why they occur and how to prevent them.