CPS Newsletter, Summer Edition Released!

NewsImageThe latest newsletter from the Center for Patient Safety has been released. You won’t want to miss the best practices and patient safety resources in this issue!

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Improving Event Investigation through the Development of SPRINT: Serious Patient Safety Event Rapid Investigation Teams. 4

Facing use of street drugs and alcohol, and decreased availability of medical care and facilities for individuals suffering mental or behavioral illnesses, Liberty Hospital has been able to stem the tide using a multi-disciplinary approach to helping create a safer care environment for staff and patients alike. 6

What the AHRQ guidance means for providers and their patients. 11

Cases involving the Patient Safety and Quality Improvement Act continue to work their way through state and federal courts. 15

New CPS report seeks to raise awareness of safety concerns in the EMS community. 16


  • Call to Action: Change the Statistic
  • Safety Insider
  • Watch Your Step, a Falls Analysis
  • New CPS Report Seeks to Raise EMS Awareness: EMSForward
  • CPS Unveils New Website
  • Put the Focus on Safer Care in EMS Community
  • PSO Update: For PSO Participants

And the Court Says… A Contract is Not Enough

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.


PSO 101: Introduction to PSOs

November 17 @ 12pm CST   – Free webinar

Questions and Answers signpostConfused about Patient Safety Organizations (PSOs)?   You’re not alone!

Join the experts at the Center for Patient Safety as they describe the basics of the Patient Safety and Quality Improvement Act (PSQIA) and provide an introduction to the terminology and concepts of PSO participation.  Applications to EMS, LTC, medical offices, and hospitals will be presented.   Q&A available during webinar.   Register

PSO Legal Update

Cases interpreting the Patient Safety and Quality Improvement Act (PSQIA) continue to wind their way slowly through the courts. Two new Florida trial court orders have recently reinforced the strength of PSQIA protections in that state: the cases are:

Loyless v. Flagler Hospital et al., No. CA12-2401 7th Judicial Circuit, St. Johns County, FL

PETRASKIEWCHZ v. Laser Spine Institute et al., No. 13-CA-14394 13th Judicial Circuit, Hillsborough County FL (August 10, 2015)

The Loyless order is very short. The court conducted an in camera review of the documents requested by the plaintiff and held that the documents were protected PSWP. It reinforces earlier advice from CPS that participants should anticipate that a judge may want to look at the materials for which they claim protection.

The Laser Spine Institute (LSI) court produced a more extensive order that analyzes the intricacies of Florida law. Florida courts have produced some challenging decisions in the past. The opinion discusses the history of the PSQIA, including quotes from the Final Rule and Congressional Hearings leading up to the law.

Briefly, the LSI court held that 1) the PSQIA supersedes Florida’s Amendment 7 and 2) a provider can prepare PSWP separate from the mandatory state reporting system and claim PSQIA protection for its PSWP.

Highlights of the LSI case

  • The Vice President for Nursing and Surgical Services submitted an affidavit and also testified at the evidentiary hearing about the organizations Patient Safety Evaluation System (PSES) and procedures for generating PSWP. This was the key evidence that convinced the court about protections; preparation for this step is vital, as is having a sound PSES and related policies.
  • LSI initiated a separate process (“Code 15 reports”) for investigating and reporting state-reportable events as soon as they were identified within the PSES. That work proceeded independently of ongoing work inside the PSES. Only the work conducted inside the PSES generated protected PSWP. Everyone acknowledged that the Code 15 information generated outside the PSES was discoverable under the terms of the PSQIA. The opinion notes that the only information the provider was required to report to the state was an Annual Report that included aggregated and summarized information about reportable incidents, and that the Annual Report contained nothing defined by LSI as PSWP.
  • LSI had a very broad process for gathering information about adverse events, incidents and variances. The process for each type of information inside the PSES was well-defined. The information gathered at this stage was much broader than the information that must be reported under Florida law, which only includes selected serious events. The broad scope of review within the PSES seemed to influence the court, which contrasted it to the narrow reporting under state law. The court specifically noted that PSWP can be protected as soon as it is created within the PSES or reported to the PSES, and that protection does not depend on the specific data having been reported to the PSO. CPS has always recommended that participants have clear pathways for information within and outside their PSES. The LSI case reinforces the need for that clarity, and also supports the availability of PSQIA protection for work that takes place in a well-defined PSES.

CPS Releases Annual PSO Report

The Center for Patient Safety has released the 2014 PSO Report, containing findings reported by healthcare providers.

The data contained in the report is from the Center for Patient Safety’s PSO database. Licensed healthcare providers may participate in a PSO in order to share information, learn from the sharing, gain federal protection to support open reporting and ultimately reduce mistakes and patient harm. PSO participation is voluntary and organizations may choose to submit most or all adverse events or they may choose to submit only the more severe adverse events to share lessons learned. The event types and their severities, along with additional information, contained in the report are deidentified as required by the PSQIA.

The goal of the report is to present an overview of the findings within all of the events reported to the Center’s PSO, to learn how and why events are occurring, and inform providers and others about how to prevent future occurrences.

General CPS findings include: (more…)

About Patient Safety Organizations (PSOs): Did You Know?

Now that Patient Safety Organizations (PSOs) have been in existence for more than five years, the federal Patient Safety and Quality Improvement Act (PSQIA) is better understood, and knowledge about the Act has increased. Still, there are a number of questions we commonly receive at the Center for Patient Safety.   Here are the top 10 questions, answered by the Center’s Patient Safety Specialist, Eunice Halverson at [email protected]:

Why should a health care provider join a PSO?
PSOs are independent, external experts who can collect, analyze and aggregate patient safety work product to develop insights into the underlying causes of patient safety events. Communications with PSOs are protected to allay fears of increased liability or fear of sanctions. With this federal protection, healthcare providers can share information with other participants, via the PSO, and learn from each other to ultimately improve patient care. More information is available from the AHRQ on working with a PSO.


Center releases Fall 2014 EMS PSO Newsletter

Fall EMS 2014The latest newsletter from the Center for Patient Safety has been released. The Fall 2014 EMS PSONews contains information on the recently released PSO Safety Alert and EMS Safety Watch, articles on the legal environment to help maximize federal protections from the PSO, patient safety culture topics, and much more!   Download the newsletter or view on Issuu.

Ask the Lawyer: EMS PSO and the Law


Date: October 1, 2014
Time: 11:30-12:30 Central
Cost: FREE
Suggested Attendees: EMS Leadership including Board Members and legal representatives

Watch the recording

Please join us for a special webinar featuring Kathy Wire, JD, MBA, CPHRM, Center for Patient Safety (CPS) attorney, on October 1, 2014. This event is an opportunity to learn more about CPS and how your agency can benefit from participation in a Patient Safety Organization (PSO).

Did you know there is little to no legal protection for peer review or safety and quality improvement work in EMS?   The CPS is a Federal listed PSO that offers you and your service protection for this important work.


Mixed results from Kentucky Supreme Court

The Kentucky Supreme Court has issued its anxiously awaited opinion in Tibbs, et al. v. Bunnell (2012-SC-000603-MR). The opinion is available online here. Earlier in the case, the Kentucky Court of Appeals ruled that only work reflecting “self-examining analysis,” could be protected PSWP, eliminating data or reports used as part of that analysis from protection. The hospital appealed, with support from the national PSO community. The Kentucky Supreme Court rejected that restriction based on the language of the law and final rule.   It went on to examine the definition of PSWP as applied to the information sought by the plaintiff, which included incident reports. (more…)

PSOs Are Watching New Florida Decison about PSWP

A Florida trial court order regarding the discovery of hospital incident reports is circulating in PSO circles.   (Charles v. Southern Baptist Hosp. et al., Duyal County, Case No. 15-2012-CA-002677.)   The order expresses a very restrictive view of PSWP (more below) and the hospital has expressed an intention to appeal the order.   As a trial court order in Florida, it has no value as precedent in any other jurisdiction, even within Florida.   However, the order will be part of the ongoing discussion about PSO protections, so CPS wants its stakeholders to understand it. The key facts:

  • Florida has very specific requirements for hospital risk management, including staff licensure and submission of certain incident reports to the state.   The statute also requires the hospital to gather information via incident reports that may not be reported to the state, but which is necessary to carry out the mandated activities.
  • The discovery request specifically asked for reports prepared pursuant to parts of the statute.
  • The court recognized the applicability of the Patient Safety Act and accepted that the hospital had a PSES and that the information was utilized appropriately in that context, and therefore would be protected PSWP except for the state risk management and reporting requirements.
  • The court found that the need to gather the information under state law and to report some of it precluded it from being protected PSWP. (more…)


PSO Case Law: Ungurian v. Beyzman, et al., 2020 PA Super 105:

A recent Pennsylvania case shows how courts narrowly interpret the PSQIA, ignoring the D & A pathway and the clear language of the Final Rule. (Ungurian v. Beyzman, et al., 2020 PA Super 105). The cour

Joint Commission New Sentinel Event Alert 61: Managing the Risks of Direct Oral Anticoagulants:

The Center for Patient Safety wants to share this important harm-prevention advice from The Joint Commission and its Sentinel Event Alert: Managing the Risks of Direct Oral Anticoagulants. The Joint Commis

CPS Safety Watch/Alert – Culture Can Improve the Control of Multi-Drug Resistant Organisms:

Issue: A number of events reported co CPS’ Patient Safety Organization (PSO) demonstrate poor handoff communication about the patients’ infectious disease status Examples include: Patient with

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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.