Patient Safety Work Product

Patient Safety Work Product is defined in 42 U.S.C. 299b-21 as any data, reports, records, memoranda, or analyses, that are assembled or developed by a provider for reporting to a PSO; are reported to a PSO; are developed by the PSO for patient safety activities; or that identify or constitute deliberations or constitute information reported through a patient safety evaluation system.

In the Notice of Proposed Rule Making (NPRM), there is an extensive discussion of how information becomes Patient Safety Work Product, beginning on page 8121. In the final rule, the department did not change the definition of Patient Safety Work Product, but did change the timing of application of protection by allowing protection prior to reporting. Thus, the discussion in the final rule, beginning on page 70740 (“When is Information Protected”), read in conjunction with the aforementioned NPRM discussion, provides a complete view of the definition of Patient Safety Work Product.

Also attached to this post are presentations addressing some of the relevant court cases regarding the PSWP privilege and documenting the Patient Safety Evaluation System.