Episode #105 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 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 Masimo, a major corporate supporter of APSF. Masimo has generously provided unrestricted support to further our vision that “no one shall be harmed by anesthesia care”. Thank you, Masimo – we wouldn’t be able to do all that we do without you!”

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. We are going to get into the position statement shortly on this podcast, but first we are going to hear from on the APSF board members who was instrumental in putting together this statement. Let’s take a listen.

[Rebello] “My name is Elizabeth Rebello, and I am a Professor of Anesthesiology and Perioperative Medicine at the University of Texas MD Anderson Cancer Center. I also serve on the board of the APSF and serve as the chair of the APSF Medication Safety Patient Safety Priority Group.”

[Bechtel] To kick off the show today, I asked Rebello what motivated her interest in medication safety and medication error in the first place. This is what she had to say.

[Rebello] “I became interested in the topic of medical error and specially medication error when I was a resident and witnessed the inadvertent administration of rocuronium in place of midazolam as the vials looked incredibly similar in the holding area. The attending physician who administered the medication recognized his error and quickly intubated the patient who suffered no untoward effects. I recognize that often times these errors tend to recur. They are preventable and there are systems issues that could be addressed the prevent or mitigate these types of error.”

[Bechtel] Have you witnessed a medication error or perhaps inadvertently administered an incorrect drug or dose to a patient? This is a big threat to patient safety and anesthesia professionals routinely administer medications to patients and we must remain vigilant to help keep patient safe. Let’s get into the article.

The article opens with the executive summary that I will read now:

“Preventable harm from the systems of care intended to improve health continues to occur at an unacceptable rate in the United States. Our hearts go out to patients, families, and caregivers who have suffered preventable harm related to health care. Healthcare systems have an opportunity to learn and improve from each episode of preventable harm. Accordingly, every preventable patient death or injury must energize our efforts to prevent future patient harm. APSF believes that the criminal prosecution of healthcare professionals will make the work of preventing harm more difficult by shifting the focus from needed system improvements. This position statement outlines the rationale for opposing criminal prosecution of individual healthcare professionals. It recommends that all healthcare systems and organizations aggressively act now to improve their cultures, processes, and training to reduce errors of all kinds and, specifically considering recent events, medication errors. Some specific actions are recommended as examples of actionable steps. Additionally, individual healthcare professionals are encouraged to be mindful of their role in preventing errors, and reporting errors that occur and to collaborate with their organizations to proactively identify and improve the flaws in the systems in which they work that lead to preventable patient harm.”

The article continues by highlighting the long history of dedication to patient safety by the Anesthesia Patient Safety Foundation and its influential work in improving patient safety during anesthesia care over the past 35 years and counting. Preventable adverse events that lead to patient harm are awful and to the patients and loved ones who have suffered following an adverse event, the APSF expresses heartfelt condolences and continues to be driven to work towards our goal that no patient be harmed by anesthesia care.

Despite considerable progress and effort, medical errors continue to occur. Healthcare systems and healthcare professionals need to be responsible for these errors, and can do this by recognizing and reporting errors, and implementing measures to prevent the error from ever occurring again.

We have talked about the criminalization of medical error before on this podcast when I spoke with Alan Merry for his work in this area in New Zealand. This was something that got Merry interested in and passionate about patient safety in the first place. Check out episode 90 for more information.

The APSF  position statement comes following the recent case of a Tennessee nurse who was convicted for gross neglect of an impaired adult and criminally negligent homicide following a medication error and failure to monitor. The outcomes of the conviction included the court granted judicial diversion and the sentencing included three years of supervised probation. The APSF position is that bringing this case of medication error and failure to monitor to prosecution and conviction of the nurse is unjust, and is counterproductive to preventing future medication events and preventing future patient harm. This is a much bigger, systems issue. The APSF advocates for changes on the healthcare system level to improve the culture of safety and eliminate the current standard of practice in medicine that accepts the normalization of deviance which allows for and continues to put patients at risk.

The phrase normalization of deviance comes from the book, “The Challenger Launch Decision” by Diane Vaughan and refers to the following. It is a stepwise process of minor changes from normal procedures that are small enough to be observed, but also accepted, rather than one giant jump that is unacceptable. These minor changes are typically made because it is more efficient or easier to accomplish the work within the systems in place by doing so. Over time, as long as adverse events do not occur, these new deviated procedures become normalized. When this concept is applied in healthcare, it threatens patient safety by increasing the tolerance for risk and the likelihood of an adverse event occurring in the future. It also runs contrary to the ‘culture of safety’ principles.

This event in Tennessee represents one event out of a much greater unknown number of similar events that occur in our current healthcare system. The next step must be to prevent future errors and systems failure that threaten patient safety. The APSF provides a call to action for “all healthcare systems, professional societies, healthcare professionals, and appropriate government agencies to take energetic, collaborative action to create and continuously improve systems of care so that such errors are nearly impossible. At the same time, the APSF will take action to reduce medication errors, and also to advocate for and support those healthcare professionals who are treated unfairly when they have acted in good faith in caring for their patients.” This threat to patient safety is bigger than just anesthesia or perioperative care and the APSF acknowledges that this applies to all healthcare.

Next up, the APSF address why it believes that the criminal prosecution of this case was unjust and counterproductive. Using the reported facts, there were systems and human factor failures that led to this mortality rather than the sole responsibility lying on the shoulders of the involved health care professional. And this is not to say that the healthcare professional does not have responsibility for this case with follow-up actions that may include education, monitoring of medication management competencies, and disciplinary action. The prosecution of this case is not supported by the framework of “just culture” that improves healthcare safety. Instead, the outcome of this case may be a threat to patient safety and put patients at even greater risk for harm if healthcare professionals who fear prosecution and retribution do not report errors, which means that the errors cannot be addressed, leading to additional patient harm in the future.

This case of criminal prosecution following a medical error leaves a big hole in the patient safety framework since there is no follow-up related to discovering the underlying causes of patient harm that may include policy failures, implementation hurdles, or the impact of human factors to mitigate the risk of the system failing in the future. The pathway to criminal prosecution diverges from important steps for improved patient safety that include evaluating best practices, creating consensus statements, and coming up with, innovating, and delivering critical policy recommendations. When medical errors occur, it is vital for organizations, institutions, and individual healthcare professionals to work together to ensure that the healthcare system remains dedicated to addressing the error and adverse event with the overall goal of delivering safe, quality patient care.

An important consideration of this case of criminal prosecution of a healthcare professional following a medical error is that it is rare. At this time, it does not represent a trend. In the anesthesia literature, there are almost no events except for those related to truly egregious actions or inactions. However, as a result of this case, healthcare professionals have expressed concern for being prosecuted for actions taken in good faith that led to an adverse event due to an error. This fear is understandable and may lead to healthcare professionals not reporting errors in the future or even leaving the profession altogether.

So, why is the APSF speaking out about this now? This is the time for the APSF to speak out given our history of advocacy for patient safety and to join the other healthcare organizations that have spoken out about the injustice, unfairness, and harm following criminalization of medical errors already. In addition, the APSF is adding to the conversation by highlighting that this event is about more than the criminal prosecution, it is about the faulty systems of care and there is a lot of work to be done to make healthcare safer for patients and the healthcare professionals working in this system.

If we look back to the founding of the APSF, this occurred during the time of evaluating adverse outcomes as a way to progress tort reform to prevent unreasonable malpractice awards. Dr. Ellison C. Pierce served as the President of the American Society of Anesthesiologists in 1984 and put out the call to action to focus on prevention of medical errors that lead to adverse events. He helped to create the APSF. Now, over 30 years later, this position statement continues the APSF mission of advocating for patient safety through the prevention of errors leading to adverse events as the way to help prevent the criminalization of medical error.

If this case is just the beginning of a push towards increased criminal prosecution of medical error going forward, that would constitute a big threat to patient safety. Significant errors continue to occur in healthcare leading to adverse events, but United States still does not have a safe and just culture in healthcare institutions that supports reporting poor systems of care, near misses, or errors in order to prevent future errors that threaten patient safety. Here is the call to action by the APSF that I will read now:

“For that reason, the APSF is urging that cases like this never be pursued by prosecutors, who should have the best interests of patients and society at heart. And we are calling to action all stakeholders to proactively assess their systems of care to identify and prevent similar events from happening across all healthcare settings.”

We have more to talk about regarding this position statement by the APSF and we will hear from Rebello again. We hope you will join us next week as we discuss a just culture and a culture of safety as well as several more critical questions including when it might be appropriate to prosecute a healthcare professional for errors, what healthcare organizations and individuals need to do to improve patient safety, what steps individuals can take now to be a patient safety champion at their institution. Plus, we will read the APSF position statement. So, mark your calendars and we tune in next week.

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.  Did you know that we have a new Patient Safety Resource on our website? That’s right, head over to APSF.org, click on the Patient Safety Resource heading, 5^th one down is the newest section, “In the Literature.” Check it out so that you can stay up to date with the latest patient safety summaries of the best medical journal articles from the APSF Newsletter Editorial Board.

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

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