Episode #106 Criminalization of Medical Error: A Call to Action

Hello and welcome back to the Anesthesia Patient Safety Podcast.  My name is Alli Bechtel and I am your host. Thank you for joining us for another show. Today, we are once again talking about a very important topic that has huge implications for patient safety and the health care professionals providing care to patients.

Before we dive into the episode today, we’d like to recognize Blink Device Company, a major corporate supporter of APSF. Blink Device Company has generously provided unrestricted support to further our vision that “no one shall be harmed by anesthesia care”. Thank you, Blink Device Company – we wouldn’t be able to do all that we do without you!”

Thank you for tuning in to Part 2 on this important topic. Our featured article today is the “Position Statement on Criminalization of Medical Error and Call for Action to Prevent Patient Harm from Error.” This was published online on May 25^th of this year. To follow along with us, head over to APSF.org and click on the Patient Safety Resources heading. Fourth one down is News and Updates. Then scroll down to May 2022 and our featured article.  You may have heard about this position statement in the news recently or seen a post on Twitter or listened to Part 1 on the podcast.  We are continuing the discussion today. Here we go!

We left off with the APSF addressing the challenging question of when it might be appropriate to prosecute healthcare professionals for errors. There are some instances where criminal prosecution is appropriate and beneficial for patient safety. This is when a healthcare professional demonstrates a pattern of reckless behavior while providing care, commits errors that lead to harm while under the influence of substances that impair performance such as drugs and alcohol, or when harm is the intended outcome. By definition, this last one is not even an error, since the harm is intended.

What is the role of healthcare organizations in preventing errors and addressing errors that have occurred? This is an important question as we move forward from this especially because there is still a high rate of preventable harm that occurs in our current healthcare system. Progress has stalled towards improved patient safety due to lack of collaboration between stakeholders to identify risk of harm, innovate to ensure that safety procedures and technologies are in place, utilized, and continuously improved. Here are the responsibilities that the APSF lays out for healthcare systems and healthcare professionals:

• “Ensure patients and family are treated with compassion and transparency.
• Disclose to the appropriate authority (e.g., local or state) when harm resulted during the delivery of care.
• Operate on the principles of a “Just Culture” and “Culture of Safety.”

Let’s take a moment here to define Just Culture and Culture of Safety. Let’s start with “Culture of safety” which includes the attitudes and behaviors directed toward patient safety with the goal of reduced patient harm that are demonstrated within a healthcare facility or institution. Within a culture of safety are these three critical components

• Fair and just culture
• Reporting culture
• Learning culture

If we look a little closer at the Joint Commission “Patient Safety Systems” publication, the Joint Commission provides characteristics of a culture of safety that include the following:

• “Staff and leaders value transparency, accountability, and mutual respect.
• Safety is everyone’s first priority.
• Behaviors that undermine a culture of safety are unacceptable.
• Staff recognize that systems have the potential to fail and are, therefore, mindful of identifying hazardous conditions and close calls before a patient is harmed.
• Staff report errors because they know the information can be used to address system flaws that contribute to patient safety events.
• Staff create a learning organization by learning from patient safety events to continuously improve.”

A “Just Culture” is one that acknowledges that humans may make mistakes and this is more likely to occur when there are system flaws and failures, but the individuals should not be held solely responsible for errors that occur within a flawed system that needs to be improved. The terms are crucial for understanding what is at stake with criminal prosecution of medical error.

Now, we are back to the list of the responsibilities of healthcare institutions and professionals developed by the APSF in their position statement.

• “Employ medication safety techniques and technologies that prevent the types of errors represented in the case in Tennessee and others nationwide. These technologies can force safe function and mitigate errors contributed by humans and other system factors and may include the following:
  • Use prefilled medication syringes.
  • Use barcode/RFID (radio frequency identification) technology for removal of medications from an automated dispensing cabinet.
  • Develop a multidisciplinary medication safety committee that meets regularly to evaluate all safety threats in your system.
  • Create a culture, reflected in policy, where all providers have a defined mechanism to report near misses and medication errors and are encouraged to speak up without fear of retaliation and provide actionable change when patient safety threats are observed. This culture change may involve the addition of a medication safety officer who engages healthcare professionals and their organizations to implement best available evidence-based practices to improve medication administration.”⁹
• And finally, “Review and consider for implementation the items in the plan of correction¹⁰submitted by the organization involved in this event with special attention to
  • Patient transport policies
  • Communication of critical patient information during handoffs of care.”

Perhaps this case is a motivation for you to act now to help prevent future medical errors and improve your institutions culture of safety. What can you do? Here are some critical action items for you to do:

• “Evaluate medication dispensing methods for high risk drugs, e.g., generic vs. brand name, therapeutic area, location of use, and consider evaluation of current workflow to enhance safety checks prior to medication administration.
• Only use a medication dispensing unit override when required in urgent or emergent situations where patient well-being is at risk.¹¹
• Except in case of emergency, institute double medication verification systems for all override pathways when removing medication from automated dispensing cabinets without pharmacist review.
  • Ensure appropriate monitoring of patients receiving high-alert medications.
  • Do not contribute to or enable a culture where “normalization of deviance” and associated practices occur.⁵
  • Empower others and yourself to report actions that may put patients at risk and remediate them.⁷

Have you looked into these systems at your institution? What changes need to be made to improve patient safety? You can be the next patient safety champion at your institution.

Before we wrap up for today, let’s look closely at the APSF Policy on Criminalization of Medical Error. This provides a road map for the APSF going forward.

First, what steps will the APSF take if a perioperative professional is prosecuted for an error unjustly in the future?

1. Learn as much as possible about the circumstances of that event.
2. If warranted, provide information to a prosecutor about system issues and the harm that would be done by prosecuting a healthcare professional who intended no harm and had helpful intent.
3. Make public statements about the harm of unreasonable retribution for medical error reporting to patient safety in prosecuting healthcare professionals.
4. Provide comfort to the healthcare professional.

Second, what steps will the APSF take to improve patient safety following medical errors and adverse event cases such as this one?

• Make public statements about efforts by organizations and government agencies to improve patient safety, specifically medication error, which is still being given too little focus given its frequency and the continued extent of injuries.
• Make best practices available to all healthcare practices and professionals that can be used to reduce medical error.
• Make information available to patients so they can actively contribute to and monitor their care plan to optimize safety.
• Work collaboratively with professional organizations and advocacy groups to enhance awareness of the problem of medical errors and system failures that lead to adverse events to identify and implement best solutions.
• Continue to convene consensus processes for recommendations on medication safety.

There is still a lot of work to be done to improve patient safety and we need all the help we can get from national, state, and facility policies that ensure the process for continuously evaluating the systems of care and making improvements to these systems that decreases the risk for medical errors and the resultant patient harm. Another consideration is the role of the Centers for Medicaid and Medicare Services Conditions of Participation which has required safety components that include evaluation of facility safety practices with required improvements when necessary and sharing of national best practices. This patient safety movement involves a lot of stakeholders including patients, families, healthcare professionals, healthcare organizations, professional societies, policy makers, manufacturers, technology companies, legal professionals and government agencies. By working together, we can work to prevent errors and keep patients safe during anesthesia care and overall healthcare. Let’s get to work!

We are going to hear from Elizabeth Rebello again as she shares what she hopes o see going forward. Let’s take a listen now.

[Rebello] “Moving forward, I hope that our goal continues to be to make the care of our patients safer. In doing so, it is important to recognize that criminal prosecution of health care providers is rare and counterproductive in most situations. Health care professionals need to feel supported to speak up and report errors. It is with this dialogue that we can prevent future harm.”

Thank you so much for Rebello for contributing to the show today. There is a lot of work to be done in this area, but the APSF and all healthcare professionals dedicated to patient safety are up to the challenge.

If you have any questions or comments from today’s show, please email us at [email protected].

Visit APSF.org for detailed information and check out the show notes for links to all the topics we discussed today.  If you are enjoying listening to this podcast, we hope that you will take a moment to share it with your colleagues, friends, and anyone you know who is interested in anesthesia patient safety around the world! It is a easy way to discover the latest news and events in perioperative patient safety and you can listen on your commute to work, at the gym, or during a break between cases!

Until next time, stay vigilant so that no one shall be harmed by anesthesia care.

© 2021, The Anesthesia Patient Safety Foundation