And the Court Says… A Contract is Not Enough

November 19, 2015    |   By: Calevir

CPS again thanks Michael Callahan for sharing PSQIA current events. The case is Johnson v. Cook County, N.D. IL, Eastern Division, No. 15 C 741, 2015 WL 5144365; available at https://casetext.com/case/johnson-v-cook-cnty-3.

The first thing to note is that the federal court refused to apply the state peer review protection statute, a common occurrence. One of the reasons we celebrate the PSQIA is that without it, litigants in federal court often have no strong protection. Another interesting aspect of the case arises from the venue of care: the county jail. Because the plaintiff alleged systemic failures in the correctional system, the court distinguished the case from an ordinary state malpractice action and evaluated it as a federal civil rights issue.

This is the first case that looks deeply at functional reporting, the provision in the Final Rule that can protect information that has not been submitted to the PSO. The Court held that the defendant (Cook County) did not meet its burden of establishing that the information at issue was protected Patient Safety Work Product. The contract between the defendant and its original PSO defined all peer review work as “functionally reported” in the sense that it gave the PSO access to the information. However, the defendant could not (or at least did not) produce any other information suggesting that it had reported anything to the PSO.

The court’s language is worth noting:

Defendant essentially is asking the Court to presume, with no supporting documentation, that it (1) maintained a patient safety evaluation system, (2) made the Report part of its patient safety evaluation system, and (3) provided [the PSO] access to its patient safety evaluation system. In other words, Defendant is asking the Court to presume Defendant complied with the PSQIA’s reporting obligations by virtue of presenting the Court with a copy of a contract. That is not enough.

Defendant has not shown in any way that the Report was generated with a PSO or patient safety evaluation system in mind… Nowhere does the Policy mention the report will be provided to a PSO or a patient safety evaluation system, that the review and report are completed for the purpose of providing information to a PSO or patient safety evaluation system, or even that a PSO will have access to the report.

These issues will sound familiar to CPS participants, who are probably tired of CPS staff haranguing them to complete their policies and submit reports. But this case now joins others that require evidence of a valid PSES. These take-aways, adapted from Michael Callahan’ suggestions, should also be shared with any attorney defending a PSO participant:

  1. Courts will not rely on a party’s mere assertion that they have established a PSES and are participating in a PSO….
  2. Detailed affidavits are critical in establishing compliance. You should also consider submitting the template reporting forms or screen shots of the forms utilized for PSO reporting.
  3. Attach the PSO agreement. It should make reference to the compliance obligations of both the provider and the PSO, and it should address the issue of functional reporting.
  4. Be prepared to provide the provider’s PSES policy, and perhaps that of the PSO, which hopefully identifies the documents or category of documents the parties are seeking to protect.
  5. Consider including an affidavit prepared by the PSO demonstrating compliance with the Act.
  6. An affidavit and/or a memorandum of law needs to explain the concept of functional reporting to the court and demonstrate that the documents in question were in fact functionally reported. (Documenting when this occurs is a requirement under the Act.) Although information collected within a PSES remains privileged and confidential as soon as it is collected and before it is reported, one way or the other, most courts do not understand this concept.

PSOs and providers need to work together when faced with these discovery challenges.

CONTACT CPS FOR ADDITIONAL SUPPORT

BLOG:

2019 Missouri Pharmacy Patient Safety Conference:

Join the Missouri Board of Pharmacy and the Center for Patient Safety for the Board’s 2019 Patient Safety Conference.  Together, we can keep Missouri safe one patient at a time.(pharmacists only) T

Are Paramedics Ignoring Hand Hygiene?:

“Many paramedics ignore hand hygiene rules, study finds” A new study looked at hand hygiene practices of paramedics from Finland, Sweden, Denmark and Australia.  The study was featured in Health Daily

CPS Safety Alert/Watch – LIFEPAK 15 Monitor/Defibrillators:

BACKGROUND: Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK 15 Monitor/Defibrillator. Stryker has become aware that certain LIFEPAK 15 Monitor/Defibrillators were reported to expe

Read More

RESOURCES:

The Center for Patient Safety believes that collaboration and sharing are the best ways to drive improvement. We strive to provide the right solutions and resources to improve healthcare safety and quality.