Question of the Week

We have a contract with a Patient Safety Organization (“PSO”) and are concerned by the Garcia case summarized in this week’s Health Law Express.  Is there anything that we can do to enhance the eligibility of information we are generating for protection under the Patient Safety and Quality Improvement Act (“PSQIA”)?

Information becomes Patient Safety Work Product (“PSWP”) when it is collected as a part of a provider’s Patient Safety Evaluation System (“PSES”).  Therefore, it makes sense for health care providers that have an agreement with a PSO (or who are considering one) to draft a robust PSES Policy that specifically identifies information that is being collected as a part of its PSES.  The policy should also state that the information is being collected “solely” for reporting to a PSO and constitutes PSWP.  However, before identifying information to include in the PSES, a health care provider should review any applicable laws and regulations that define information collection and reporting obligations.  For example, Pennsylvania requires healthcare entities to report patient safety events to the state.  Under HHS Guidance (and most of the case law on the subject), such information would not be considered PSWP because it is not developed “solely” for reporting to a PSO – it is also being developed for reporting to the state.  The court in Garcia goes one step further, holding that a contractual obligation to generate patient safety information renders that information ineligible for protection as PSWP under the PSQIA. As noted above, this is an incredibly narrow interpretation of the privilege under the PSQIA and sees no support in the PSQIA regulations (although it is consistent with another recent case from a federal court in Oregon – Dence v. Wellpath).  The court appears to indicate that the contract’s reference to accreditation standards provides another reason the mortality review was generated, further removing it from the PSQIA protection.  However, the PSQIA regulations contain a PSWP disclosure exception for “voluntary disclosure[s] to an accrediting body.”  This suggests that information could qualify as PSWP and still be shared with an accreditation entity, such as The Joint Commission, to demonstrate that a health care provider is meeting accreditation standards.  Thus, the court’s reliance on obligations created by accreditation standards as a justification for certain information not being eligible to become PSWP is puzzling.  Nevertheless, development of a PSES is a tricky task, and a health care provider should review its information generation and reporting obligations to assist in defining its PSES and what qualifies as PSWP.