PSO Legal Update

“Licensed providers who have yet to participate in a PSO for fear of its limited scope and acceptance by the courts should reconsider this option.”  – Wes Butler, Barnett Benvenuti & Butler PLLC

Introduction

Everyone is beyond busy with COVID and its fallout. Some are dealing with the disease, others with the operational and financial obstacles imposed by COVID-inspired changes. While you continue to plan and implement safe care for patients, make sure that you are taking advantage of PSO protections for those discussions and plans.

The first part of this update will discuss the application of PSQIA principles to the COVID world, or any other significant challenge. The second is a brief legal update. Most of the discussion here relates to the “deliberations and analysis” pathway to protection, abbreviated as “D & A.”[i]
Reminder:  Information in the D & A pathway does NOT need to be reported to the PSO; it is protected as it arises from work in your PSES.

Background

For review:  The PSQIA and the Final Rule say information can become Patient Safety Work Product (PSWP) two ways. The first applies when the organization gathers and develops information for reporting to a PSO, and actually reports it. The second pathway encompasses all D & A that takes place in the PSES; it is a powerful option. Your PSO policy should describe both, by specifying the groups and individuals that staff your PSES and outlining what they do. You can do this by naming the committees supported by a committee description or charter. Document the existence and work of pop-up patient safety teams, as the PSQIA can protect their D & A as well.

While the D & A pathway protects material that never goes to the PSO, remember that you can’t have a PSES without reporting some information. The D & A pathway protects the work behind the reported material.

Your PSES in a Crisis

Another often-neglected provision of the PSQIA can help when things are turbulent. PSWP can be shared throughout the organization’s workforce, even without deidentification, so long as the sharing takes place to support patient safety activities. It retains its cloak of confidentiality, though, so all who work with it need to continue treating it as PSWP. CPS recommends that you document the sharing, if possible, including that recipients understood the protected nature of the information. Ad hoc teams formed to deal with emerging threats can use PSWP for their work, even if they are not part of the documented PSES, and everything they do to support patient safety can remain protected.  You can also require those individuals to sign a confidentiality statement (template provided in your PSO Toolkit.)

Another reminder: Identifiable PSWP cannot be shared outside of your organization, so PSWP shared in collaborative environments (such as a regional COVID response team) needs to be de-identified first.

Developments in the courtroom world

This information is compiled and provided by Kathy Wire, JD, MBA, CPHRM, Project Manager at the Center for Patient Safety.

Other Recent Developments

There are some other recent wrinkles in PSQIA practice:

  • Some attorneys are asking for Zoom meeting recordings. If the work is protected, so is the recording. Consider adding supporting language to your PSES policy, and at the beginning of protected activity in meetings.  Treat the recordings like you would treat protected minutes.
  • Plaintiffs are asking for audit trails to find out what parts of patient records Quality/Risk staff reviewed. This work, when it is part of PSES activity, constitutes deliberations and analysis. A supportive argument: audit trails related to quality are exempt from disclosure under the HIPAA privacy rules regarding rights of access under OCR guidance.

Noteworthy:

[i] Patient safety work product: (1) … patient safety work product means any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements (or copies of any of this material)

(i) Which could improve patient safety, health care quality, or health care outcomes; and

(A) Which are assembled or developed by a provider for reporting to a PSO and are reported to a PSO, which includes information that is documented as within a patient safety evaluation system for reporting to a PSO, and such documentation includes the date the information entered the patient safety evaluation system; or …

(ii) Which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system. 70798 73 Federal Register 226, p. 70798; §3.20. (Emphasis added.)

CPS’ PSO participants can contact Eunice Halverson for implementation questions or Kathy Wire for legal concerns on these or any other topics related to their PSO work.  If you are not a participant in the CPS PSO and would like to learn more, visit www.centerforpatientsafety.org or email us at [email protected].


For questions about PSO protections or PSO application in your organization, please call the Center for Patient Safety at 573.636.1014, or contact Kathy Wire at [email protected].

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