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Collecting information to ensure patient safety work product protections

Paul E. Dwyer ( is a Partner and Clint D. Watts ( is an Associate in the Rhode Island office of McElroy, Deutsch, Mulvaney & Carpenter LLP.

Most healthcare providers know that the Patient Safety and Quality Improvement Act (PSQIA or the Act) created a new kind of “work product” privilege to protect providers that choose to collect and analyze information for the purpose of improving patient safety. But many organizations have failed to consider exactly how a provider should go about collecting data to ensure that sensitive materials obtain and maintain that protection. The lack of critical thought on this issue creates uncertainty in litigation and presents an unacceptable risk for the provider. The quandary typically arises after a provider has evaluated Patient Safety Work Product (PSWP) within its own Patient Safety Evaluation System (PSES) and has decided that additional investigation or data is necessary to draw conclusions. The dilemma is whether to collect such information pursuant to the “Reporting Pathway” of PSWP, which must be reported to a Patient Safety Organization (PSO) in order to enjoy the privilege, or under the “Deliberations and Analysis Pathway,” which is privileged without reporting the information to a PSO. The statute reads in pertinent part:

[T]he term ‘patient safety work product’ means any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements – (i) which “(I) are assembled or developed by a provider for reporting to a patient safety organization and are reported to a patient safety organization; … and which could result in improved patient safety, health care quality, or health care outcomes; or (ii) which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.[1]

In this case, the provider is forced to ask a difficult question: Can we collect additional primary data in conjunction with our internal deliberations and analysis, and can we expect that information to be protected if we do not intend to report it to a PSO?

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