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New PSWP narrows providers’ definition of privileged information
Recent guidance issued by the U.S. Department of Health and Human Services (HHS) seeking to clarify patient safety work product (PSWP) privilege under the Patient Safety Act has instead stoked conflicting opinions among organizations representing healthcare providers as to how the provision should be interpreted.
Recent guidance issued by the U.S. Department of Health and Human Services (HHS) seeking to clarify patient safety work product (PSWP) privilege under the Patient Safety Act has instead stoked conflicting opinions among organizations representing healthcare providers as to how the provision should be interpreted.
In May, HHS published guidance outlining which information a provider reports to a Patient Safety Organization (PSO) falls under the Act’s federal privilege protections, which are designed to shield providers from legal action. While HHS said most providers engage with PSOs to further patient safety, some could be misusing the Act to circumvent federal or state regulatory reporting obligations.
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In some instances, providers may be maintaining required records only in a patient safety evaluation system (PSES) and then refusing to disclose the records, asserting the records in their PSES fulfill the applicable regulatory requirements while maintaining that the records are privileged and confidential PSWP.
Others may be developing records to meet obligations outside of the PSES, placing a duplicate copy of the required record in the PSES, and then destroying the original and refusing to disclose the remaining copy of the information, asserting the copy is confidential and privileged.
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“I think essentially what HHS tried to do is clarify that not every document submitted to a PSO is automatically protected,” says Julie Chicoine, JD, general counsel for the Texas Hospital Association. “In my opinion, HHS reiterated what was already established in the law.”
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HHS’ guidance sets forth three ways information can become PSWP:
1. The information is prepared by a provider for the purpose of reporting to a PSO and is reported to the PSO,
2. The information is developed by a PSO for the conduct of patient safety activities, or
3. The information identifies or constitutes the deliberations or analysis of, or identifies the fact of reporting pursuant to, a PSES
Patient medical records, billing and discharge information, or “any other original patient or provider information” is specifically excluded from being PSWP. Also excluded is information “collected, maintained, or developed separately, or exists separately, from a (PSES).” In other words, information prepared for purposes other than reporting to a PSO is not PSWP.
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However, this interpretation, combined with a Kentucky Supreme Court case (Tibbs v. Bunnell) that found PSWP privilege did not apply to an incident report generated through a hospital’s PSES because the hospital is required to develop, collect and maintain similar reports under Kentucky law, has caused confusion among healthcare organizations.
“Now, PSWP would only apply to records produced solely for reporting to the PSO,” the California Hospital PSO said in a statement to its members. “The word ‘solely’ was never used previously in relation to PSWP in either regulation or law. Providers are now faced with conflicting interpretations . . . and should carefully consider how to address requests for information that is considered PSWP and consider whether their current PSES needs to be reviewed and modified in response to the guidance.”
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The CHPSO and other PSOs – along with the American Medical Association, the American Hospital Association and the Joint Commission – petitioned the U.S. Supreme Court to review the Tibbs decision, arguing records that must be collected and maintained but not reported pursuant to state law can be collected in a provider’s PSES for reporting to a PSO, and therefore qualify as PSWP. The Supreme Court denied the request in June without comment.
While the THA’s Chicoine agrees having states deciding PSWP privilege could undermine the purpose of PSOs, she sees the recent guidance as necessary and timely.
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“In the end, I would advise providers to compare the new guidance to the original guidance and follow the examples HHS recommends, such as not putting documents not created for purposes of reporting into a PSO, “ she says. “More important, the U.S. government has outlined that by 2018, 90% of Medicare payments will need to be tied to value-based payment systems, and as Medicare goes, so goes the rest of the industry. For that reason, I think it’s incumbent upon providers to continue to embrace PSOs and the important role they play to document the value of the services they provide and minimize the impact to their reimbursement.”
