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 court discussed the PSQIA protection for two documents: an event report and a root cause analysis report.  The court’s reasoning on the two documents differed.

The Event Report

The court focused on its conclusion that the hospital did not create the event report for purposes of reporting to the PSO.  The hospital appropriately argued that its “PSES encompasses information assembled, developed, deliberated upon, or analyzed from patient safety and quality activity and includes information that may result in documents such as occurrence reports, cause analysis, and root cause analyses.” The court held that because the hospital could have used the report for other purposes and because the policy did not require its submission to the PSO, it could not be protected. The court’s opinion ignores clear language in the PSQIA and Final Rule, particularly the dropout provision, which protects such information as PSWP until the provider says it isn’t PSWP.  Also, the PSQIA allows PSO participants to share and use PSWP with their workforce to support patient safety and quality activity, as described in the hospital’s affidavit.

The Root Cause Analysis

The court also found that the RCA was not “developed for the purpose of reporting to the PSO.”  The court also focused on the fact that “information contained in the RCA is not solely in the PSES.”  This finding attempts to create a requirement that PSWP, developed in the PSES, cannot exist outside of the PSES.  However, the law and the Final Rule provide that PSWP can be shared within a participating provider’s workforce without violating the disclosure provisions, even outside the PSES.  By its holding, the court eliminates that opportunity for providers to use PSWP for the improvement of safety and quality.

Take-Aways from Ungarian

This opinion underscores the underlying challenges of defending PSQIA protections. 

  • In some jurisdictions, the courts are incredibly hesitant to enforce protections.  In all jurisdictions, the burden of establishing privilege falls on the provider, so we must be prepared to make those arguments. 
  • Most courts have no knowledge or experience with this Act.  Therefore, the provider’s counsel needs to educate the court and discuss favorable cases such as Daley v. Ingalls Hospital and Rumsey v. The Guthrie Clinic.
  • If your attorneys need additional background or help, contact your PSO before filing pleadings and affidavits for advice on how to draft those. The appellate courts look to the trial court record, which you generally cannot supplement.
  • If you think it will help, consider offering the documents for an in camera inspection by the trial court. Because sharing could constitute a disclosure (unless ordered by the court), be sure to obtain a protective order and obtain written authorization from providers named in the documents, as described in Final Rule Section 3.206(b)(3).
  • Support the ongoing education of your defense attorneys about the PSQIA, especially regarding the broad protection offered by the D & A pathway and the ability to use PSWP internally for safety and quality purposes. Some attorneys who are deeply involved in PSO litigation argue that providers can use PSWP within their workforce for ANY purpose.

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

A number of events reported to CPS’ Patient Safety Organization (PSO) demonstrate poor handoff communication about the patients’ infectious disease status.
Examples include:
~Patient with suspected TB transferred to floor without making staff aware.
~Patient transferred to ICU from ED without sharing information that patient was positive for MRSA.
~Patient directly admitted without informing receiving personnel that swab testing for influenza had come back positive.


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)
TIME:  8:30 a.m. – 4:30 p.m. (Thursday, May 9th.)


  • The Science of Safety:  Creating a Patient Safety Culture
  • Production Pressures & Pharmacy Pitfalls
  • Interruptions, Distractions & Work Overload
  • Case Studies in Safety:  Technology, Process Engineering & More
  • Blame vs. Accountability
  • Registration is FREE but SPACE IS LIMITED.


Are Paramedics Ignoring Hand Hygiene?

“Many paramedics ignore hand hygiene rules, study finds”

Hand HygieneA new study looked at hand hygiene practices of paramedics from Finland, Sweden, Denmark and Australia.  The study was featured in Health Daily News and described concerning variance in compliance of hand hygiene.  While the study didn’t look at paramedics in the United States it does it does raise the question whether hand hygiene practices would fare better in the US.

Emergency Medical Services is part of the care continuum and responds to emergency and non-emergency calls every day, therefore, creating a culture of safety that includes proper hand hygiene helps to prevent patient harm.

Read more about hand hygiene for EMS providers in this article from

CPS Safety Alert/Watch – LIFEPAK 15 Monitor/Defibrillators


  • 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 experience a lock-up condition after a defibrillation shock was delivered.  This condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions.
  • The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include an update to the firmware for a component on the System Printed Circuit Board Assembly.


  • If a device exhibits the lockup condition during patient use, the steps from the General Troubleshooting Section (page 10-18) of the LIFEPAK 15 Monitor/Defibrillator Operating Instructions should be immediately followed:
    • Press and hold ON until the LED turns off (~5 seconds) Then press ON to turn the device back on
    • If the device does not turn off, remove both batteries and disconnect the device from the power adapter, if applicable.  Then reinsert batteries and/or, reconnect the power adapter, and press ON to turn the device back on.


ISMP Update on Top Medication Safety Issues from 2018 – Webinar

ISMP Update on Top Medication Safety Issues from 2018

Medication mistakes are one of the most common errors reported to the Center’s PSO.  ISMP is offering a free webinar on November 15 at noon Central Time to discuss the top medication safety issues as well as strategies to minimize risk.  They will also discuss how drug shortages contribute to errors and strategies to mitigate risk.  Register here and please share with others at your organization.

Recognizing Fall Prevention Week

Fall Prevention Awareness Week started Saturday, September 22 and runs until Friday, September 28. has excellent resources and tools to support ongoing efforts including flyers, posters, fact sheets and videos. A fall can result in injury, trauma and even death. Sometimes the fall isn’t even the scariest part and it is the post-fall events of surgery, immobility and potentially pneumonia that result in death.

Like many baby-boomers, my mother is the caretaker for my grandmother. Now in her 90s, my grandmother is sharp as a tack, witty, and full of life, however, she is also very frail and purposeful in her movements. My mother lives in a two-story Cape-style home and serves dinner in her dining room, requiring my grandmother to venture down a flight of stairs from her bedroom. My mother’s husband has a coordinated drill with my grandmother that I always enjoy watching when I’m around. He takes her arm gently in his, stands beside her and they descend slowly and methodically down the stairs, one at a time, as if they were a single person. He matches his stride to hers, paying close attention to her hesitations, much like a dance partner. While he initially started doing the “stair dance” as a supportive function, he is actually preventing her from falling.

Not all older adults have a stair dancing partner, so it’s important to find another effective method of fall prevention. In a home with more than one floor, an electronic stair-lift may be appropriate if arrangements cannot be made for the individual to live fully on one floor. Recognizing trip hazards is also very important. My mother has three cats, so it’s necessary to ensure a cat is not underfoot when my grandmother moves about.

We are likely all familiar with an aging family member that is at risk of a fall. No matter how adamant they are about living on their own or continuing their daily routines without worry, any of us that work in healthcare recognize the serious risks. We want to protect our parents, our grandparents, or even our great-grandparents, but we must also respect their desires if they choose to age in their homes, even if they are doing so alone. Engage them in the conversation and review the checklists on, watch videos together and let them know you care about their safety.

Missouri Board of Pharmacy Regional Meeting

It was an honor to be the key note speaker for the southwestern regional Board of Pharmacy yesterday in Springfield. About 80 professionals enthusiastically learned how they can personally improve patient safety culture whether their setting is retail or hospital based. We discussed the importance of leaders “walking the walk and talking the talk” as actions speak louder than words, and then they learned from each as they shared how leaders can improve their skills. The last discussion was about the principles of high reliability – a perfect goal for pharmacists! Want to learn more? Contact the Center for Patient Safety.


CPS Safety Alert/Watch – Look Alike Sound Alike Medications


  • Kenalog 40 mg/1 ml single dose vial (contents 1 ml)
  • Kenalog 200 mg/5 ml multi-dose vial (contents 5 ml; concentration 40 mg/1 ml)

Actionable Items to Mitigate Risk:

  • Remain consistent with ordering practices. If it is your organization’s practice to routinely order single dose vials, continue ordering single dose vials. Do not switch from ordering single dose to multi-dose without appropriate communication across your organization.
  • Store multi-dose vials in different locations from where single dose vials are stored.
  • Evaluate

The Culture Connection:

  • Encourage staff to speak up and report similarities of medication and also any incidents, near misses or unsafe conditions pertaining to look alike sound alike medication.
  • Encourage staff to use two person check of medication prior to administration.
  • Leadership should evaluate the culture of their organization to ensure staff feel safe reporting incidents involving look alike sound alike medications.


EMS Patient Safety Coordinator, Shelby Cox

The Center for Patient Safety is pleased to announce the recent hiring of Shelby Cox to the new EMS Patient Safety Coordinator position.  Shelby brings many years of EMS experience and a strong passion for improving patient care.  Please join us in welcoming Shelby to the CPS team.


As a Nationally Registered Paramedic with more than 20 years invested in emergency medical services, Shelby has served in varying capacities including  ground ambulance transport, air medical services, hospital liaison, EMS education and hospital outreach management. She has a passion for helping people and has always been drawn to making a difference.  Today she is inspired to help EMS colleagues reduce preventable harm.  She describes this new role as part of an amazing journey where she can use her experience on a larger scale.


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

Read More


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.