What is a Patient Safety Work Product (PSWP)?
A PSWP is basically any patient-safety info—data, reports, notes, memos, analyses, etc.—created for and shared with a Patient Safety Organization (PSO), or generated as part of a provider’s internal PSES deliberations and review (including the fact something was reported).
Why deidentify a PSWP?
A PSWP is generally confidential, but there’s an explicit exception allowing disclosure of nonidentifiable PSWP if it meets the 42 C.F.R. § 3.212 nonidentification standard.
As with HIPAA, the PSQIA Safe Harbor provision may require removing valuable information from the work product, information that could be retained if the Expert Determination standard is met. This would allow sharing de-identified lessons learned from RCAs/near misses across a health system, with a multi-provider collaborative, in educational materials, or in a presentation, without exposing the specific provider or reporter.
What does PSQIA say?
The Patient Safety and Quality Improvement Act (PSQIA) says in 42 C.F.R. § 3.212 that a patient safety work product (PSWP) is nonidentifiable as to a particular provider or reporter if one of two things happens.
Under the Expert Determination method, a qualified person using generally accepted statistical/scientific methods determines the risk is very small that an anticipated recipient could identify the provider/reporter (alone or with other reasonably available info), or if specified identifiers are removed in a sort of Safe Harbor provision. In this way the PSQIA statute is analogous to the HIPAA Privacy statute.
Expert determination
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