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.

CONTACT CPS FOR ADDITIONAL SUPPORT

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

2016 Conference Keynote Speaker Announced: David Marx

Mark your calendar for April 7, 2016 to join us in St. Louis, Missouri, at the Crowne Plaza Hotel and Convention Center!

DMarx-8-2011-2hThe Center for Patient Safety is proud to announce David Marx, leader of Outcome Engenuity, as our 2016 Annual Patient Safety Conference keynote speaker.  As the “father of Just Culture”, David’s concepts have had steady involvement in patient safety over the last decade.  Often, adverse events are the result of bad processes – not bad people.  The strongest healthcare organizations have a culture that supports open communication.  Staff can confidently talk about adverse events and the stage is set to learn why and how the mistakes happen.  This is the only way we can work towards improvements in patient safety.Daves-Subs-book

In addition, every attendee will receive a copy of David’s latest book: “Dave’s Subs, A novel story about workplace accountability”.   We look forward to seeing you there!

Stay tuned for more information!

 

OR Medication Safety: Room to Improve

A study published in Anesthesiology found that about one in every 20 medication administrations during surgery involved an error, and up to one-third of those harmed the patient. The authors attribute the error rate in part to the absence of the safeguards that prevent errors in other parts of the hospital, such as bar coding or pharmacist review. Hospital and ASC providers, what about your ORs? Are there more errors, and if so, are they reported? Remember that this sort of investigation can be protected for providers participating with a PSO, and CPS staff can provide advice on structuring the process for its participants.

There are several specific anesthesia PSOs, both through the national association and specific provider groups. Do your anesthesia providers work with a specialized PSO? If you are a participant with CPS, we can collaborate with their PSO to achieve the best learning for all providers in the operating suite and related areas such as pharmacy, while preserving PSO protection for the work.

The study is described in a Bloomberg News article and is available to subscribers here.

CPS Safety Watch/Alert: Reprocessed Flexible Bronchoscopes Pose Risk

PSOAlert!On September 17, 2015 the FDA issued a safety communication on “Infections Associated with Reprocessed Flexible Bronchoscopes”, following its earlier communication about similar concerns with duodenoscopes/endoscopes.
This alert is to reinforce the following highlights of the report, encouraging healthcare
providers to review processes and implement steps to ensure the safety of patients:

  • Bronchoscopes are a subset of devices that pose a high risk of infection if not adequately reprocessed.
  • Between January 2010 and June 2015 the FDA received 109 Medical Device Reports (MDRs) concerning infection/device contamination associated with flexible bronchoscopes.
  • In 2014 alone the FDA received 50 MDRs concerning infection/device contamination associated with flexible bronchoscopes that prompted further investigation.
  • A small number of MDRs document device contamination despite following manufacturer’s reprocessing instructions. These reports are still being investigated.

The complete report is available here.

The earlier published FDA communications addressed concerns about:

  • The complex design of ERCP endoscopes (duodenoscopes) providing a challenge to cleaning and high-level disinfection.
  • Potential for residual body fluids/organic debris to remain in the microscopic crevices of the moving parts of the elevator mechanism and expose patients to serious infections.
  • Seventy-five MDRs received between January 2013 and December 2014 related to potential microbial transmission from reprocessed endoscopes/duodenoscopes.
  • Instances of device contamination despite strict adherence to manufacturer’s reprocessing instructions.

Complete information from the FDA on these concerns are available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm and http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454766.htm.

MITIGATION STRATEGIES TO CONSIDER

  • Strict adherence to the manufacturer’s reprocessing instructions
  • Immediate removal of use of any bronchoscope that fails a leak test or shows visible signs of damage
  • Conduct maintenance and repair according to manufacturer’s recommendations
  • Implement a comprehensive reprocessing quality control program
  • Store bronchoscopes in a manner so as to minimize the risk of contamination

RESOURCES TO TAKE ACTION

CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices:  http://emergency.cdc.gov/han/han00383.asp.

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.

Fall Newsletter Just Released

Fall 2015 coverDOWNLOAD NEWSLETTER

We hope you enjoy the latest newsletter from the Center for Patient Safety PSO!  Articles include:

  • Aligning Culture with the Strategic Plan, A success story from SSM Health.1
  • CPS Culture Stats.2
  • Culture Measurement as Key Improvement Tool, A success story from Cox Health.3
  • LTC & EMS Updates.4-5
  • Pointers for Implementing Change.6
  • PSO Legal Update.6
  • Patient Safety Insider.8
  • PSO Data Update.10-11
  • Upcoming Events.12
  • CPS Speakers: On the Circuit.12

Read on ISSUU.com

View archived newsletters

Interested in more information?  Check out the CPS Blog for the hottest news topics!

Key Learning from CPS Hosted Webinar, July 16

On July 16, CPS was pleased to collaborate with the North Carolina Quality Center PSO and the Midwest Alliance for Patient Safety and host Dr. Bill Munier from AHRQ and Michael Callahan from Katten, Muchin, Rosenman, LLP on the first of a 2-part series for our PSO participants. Some key points shared by these national presenters included:

  • The partnership between PSOs and providers is that of a social contract for national learning; PSOs accelerate learning, produce generalizable lessons for improvement and allow for comparisons and benchmarking
  • The social contract supports a two-way, vertical system for quality improvement: Providers get protections from PSOs, providers share experience (data) with PSOs, PSOs share data nationally, national learning is shared with PSOs, providers, and the nation, and quality and safety are improved nationwide – starting from the ground up
  • Benefits of working with a PSO include protections, specialized experience, and focused aspects of quality & safety
  • Benefits of PSOs also include safe tables among providers, faster aggregation of information & richer analysis, shared learnings
  • Over 5,000 healthcare providers are currently working with a Patient Safety Organization (PSO) across 29 states
  • Critical questions to ensure protections under Patient Safety & Quality Improvement Act: Are your policies in place? Did you report to PSO?
  • Healthcare providers cannot afford to miss out on the opportunity to participate in Patient Safety Organizations
  • Section 1311 (h) of the Affordable Care Act will be effective January 1, 2017 requiring hospitals with more than 50 beds to participate with a PSO.  AHRQ is providing information and resources to help providers select a PSO.

CPS Safety Watch/Alert: Prevent Violent Behavior

Safety-Watch-07.15.2015editThe Center has released Patient Safety Watch: Prevent Violent Behavior.  We encourage you to review the watch and share with others in your organization.

The incidence of physical and violent behavior continues to rise across the United States, and reports in the Center for Patient Safety’s PSO database support this trend. Events include throwing furniture, biting, hitting, verbally abusing and physically attacking employees. Although most of the events resulted in no harm, it’s important to learn from these incidents and take action before employees, patients and visitors are injured.  Read more: download the Watch.

CPS is pleased to speak on upcoming First Watch webinar!

First Watch Header

Wednesday, July 22nd at 10 am PT/12 pm CST  Register Now for this Webinar

Patient Safety Organizations are becoming an integral part of the safety of our our patients and caregivers. For the benefit of your agency and it’s people, we highly recommend you learn more about the benefits of joining a Patient Safety Organization (PSO). Being part of a PSO can reduce legal exposure to issues found during your QI process and lead to better, safer, patient care.

We recognize that every agency operates differently and has different needs, and would like to provide you with two different webinar opportunities to learn more about what one or both of these PSO organizations have to offer.

In this webinar you will learn how participating with a Patient Safety Organization (PSO) can protect the quality and safety work in EMS, as well as support your EMS staff.  Participating in a PSO can provide a number of benefits like improved patient safety and quality improvement, or becoming proactive in preventing adverse events and unsafe conditions instead of just being reactive.

We think this is very important, and we highly encourage you to attend this webinar to learn more about becoming a member of a PSO, and the benefits each offer their members.

Wednesday, July 22nd at 10 am PT/12 pm CST

As a federally listed Patient Safety Organization (PSO), CPS is a private not for profit organization that works with EMS. There are many benefits to participating with a PSO, including federal protection and confidentiality privileges as well as shared learning about adverse events, near misses and unsafe conditions. The Center provides PSO Alerts and Safety Watches as well as offers best practices on up-to-date lessons learned in healthcare. In addition, it supports the creation and maintenance of a safety culture and offers services to measure and improve healthcare culture, such as a safety culture survey, Just Culture training, CUSP eduction, and more.

In this webinar you will hear from CPS members John Russell, MD, President of Cape County, MO, Jay Reich, MD of Kansas City, MO and Leo Hsu, MD and John Romeo of St. Charles County, MO, as well as CPS EMS Project Manager Lee Varner.

Register Now for this Webinar

BLOG:

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

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.