“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
This information is compiled and provided by Kathy Wire, JD, MBA, CPHRM, Project Manager at the Center for Patient Safety.
As Patient Safety Organizations (PSOs) had hoped, all the courts examining the Act continue to recognize its protection of properly developed Patient Safety Work Product (PSWP), in both state and federal courts. As more cases invoke Patient Safety and Quality Improvement Act (PSQIA) protections, their many factual situations show how broadly that protection can apply. In a recent Tennessee case, a doctor was accused of conducting an improper body cavity search of a patient brought in by the police. The court held that the PSQIA could apply to protect information developed during the investigation of that and other events at the hospital.
In California, a hospital found itself at odds with one of its unions, as it tried to clarify the proper use of reporting forms to clearly differentiate data generated for its Patient Safety Evaluation System (PSES). Another clear theme from the case: PSWP can be used judiciously inside the organization for other purposes; it just can't be disclosed outside the workforce of the PSO participant.
A Kentucky federal court faced the argument that the Patient Safety Act only protected PSWP in medical malpractice cases, and soundly rejected it. In that employment case (Tinal v. Norton) a physician tried to obtain reports of incidents involving other physicians. The case is discussed in more detail below.
As these cases illuminate the widespread practical issues that arise from PSO participation, they also emphasize the importance of discipline and consistency in designing and implementing a PSES. Whether the concern is clearly including an investigation in the PSES or making sure that employment issues are reported on a non-PSES form, PSO participants need to make sure their procedures are clear and are followed.
Where copies of the orders and opinions about the Patient Safety Act are available, you can request them from the Center by contacting Kathy Wire at email@example.com.
The cases have also shown how important it is for legal counsel to understand the law and your own procedures. Here are some basic tips, if you find yourself in litigation where the PSO protection may be relevant:
CPS staff are happy to work with any participant or its attorneys facing litigation about their own structures, their relationship with the CPS or the PSQIA. There is always information on current written decisions on the CPS website and PSO email alerts will describe any new developments.
CPS strives to provide the best and most current information about the legal decisions that will further refine our understanding of the Act. To do that, CPS staff seek out many sources of information about legal developments involving the PSQIA. For example, Kathy Wire, an attorney with CPS, participates in an American Health Lawyers Association work group of PSO attorneys. That group is chaired by Michael Callahan and includes attorneys such as Wesley Butler, who often work at the forefront of PSQIA cases.
Through working connections with a number of other PSOs, CPS staff obtain direct information about legal developments affecting them.
The District Court for the Western District of Kentucky has issued an incredibly helpful opinion for PSO's and their participants. (Tinal v. Norton Healthcare, No. 3:11-CV-596-S, May 8, 2014) A copy of the opinion is available and a summary of the opinion by one of the law firms involved is also available. The court reviewed the law and its history comprehensively. Lawyers defending PSO participants should read it for guidance on how to approach PSWP protections.
The court noted that the statute uses "plain and unequivocal terms" to set out the privilege, and stated, "No ambiguity can be read into the privilege statute." The plaintiff's claim was for employment discrimination under the federal civil rights statutes, and she claimed that the PSQIA should only apply in medical malpractice cases. The court disagreed, finding that "[w]e have no authority to go behind the plain meaning of the statute.
Norton had prepared a privilege log, listing the documents for which it claimed the privilege, and the court held that it need not describe the content of each one, other than to describe its preparation and sourcing as PSWP. The court did review the documents in camera, and litigants should be prepared for that step. Once again, the case relied on a finding that the provider had (1) defined a PSES, (2) performed its analysis and generated the documents as part of the PSES, and (3) reported to the PSO per hospital policy.
Though this decision does not control any cases outside its own district, we hope that it will be an influential analysis, and one that participants and their counsel can use to construct their own arguments.
"The significance of [the Norton Court] opinion cannot be understated as it is the first time a federal court has explicitly evaluated the scope of the PSQIA privilege protections and its application in both state and federal proceedings as well as the elements of the patient safety work product privilege. 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
1 Gulley v. Lapaglia, 2014 U.S. LEXIS 7074. The court did not hold that any documents were protected, and indicated that the doctor would still need to produce a privilege log listing them by categories, so the court could make a more detailed determination.
2 Garcia ex rel. NLRB v. Fallbrook Hosp. Corp., 952
F.Supp.2d 937 (S.D. CA June 7, 2013).
For questions about PSO protections or PSO application in your organization, please call the Center for Patient Safety at 888.935.8272, or contact Kathy Wire at firstname.lastname@example.org.
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