Episode #34 Culture of Safety: Featuring Adverse Event Disclosure

March 3, 2021

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Welcome to the next installment of the Anesthesia Patient Safety podcast hosted by Alli Bechtel.  This podcast will be an exciting journey towards improved anesthesia patient safety.

We are excited to dive into the February 2021 APSF Newsletter today and talk about culture of safety and reporting of adverse events. According to the Agency for Healthcare Research and Quality or AHRQ, there are 4 key features that are found in an established culture of safety:

  1. Recognition of the high-risk nature of health care with a commitment to “achieve consistently safe operations”
  2. A blame-free environment where individuals can report errors or near misses without fear of reprimand or punishment
  3. Teamwork across ranks and disciplines to address patient safety problems
  4. Commitment from the organization to provide resources to address safety concerns.

We review several principles of disclosure to patients which should occur in the following situations:

  • When the adverse event has a noticeable effect on the patient that was not previously discussed with the patient as a known risk of the procedure or medication
  • When the patient requires a change in care due to the adverse event
  • When there is a risk to the patient’s health in the future due to the adverse event
  • When the adverse event leads to providing a treatment or procedure with the patient’s consent

Check out the featured article here. https://www.apsf.org/article/enhancing-a-culture-of-safety-through-disclosure-of-adverse-events/

Additional resources for the disclosure process:

Thank you to Chris Cornelissen, DO, FASA for contributing voice clips for the show today.

Check out the list of past ASPF Grant Award Winners here. https://www.apsf.org/grants-and-awards/grant-recipients/

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© 2021, The Anesthesia Patient Safety Foundation

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. I have been talking about the newly released February 2021 APSF Newsletter and today we are finally going to open up the newest newsletter and talk about it on the show…with exclusive content from one of the article authors.

Before we dive into today’s episode, you’ve heard me recognize our corporate sponsors on this show, but there’s another supporter who is absolutely essential – YOU! Every individual donation matters so much. Please visit APSF.org and click on the Our Donors heading and consider making a tax-deductible donation to the APSF.

To follow along with us, starting at www.APSF.org, click on the Newsletter heading, first one down this time is the current issue. Then, scroll down while looking in the left hand column until you see the article, “Enhancing a Culture of Safety Through Disclosure of Adverse Events” by Cornelissen and colleagues. Culture of Safety is such a big part of keeping patients safe during anesthesia care. It was one of the APSF Patient Safety Priorities for 2020-2021 including Culture of safety: the importance of teamwork and promoting collegial personnel interactions to support patient safety. Related to this priority, the APSF has presented information during the 2017 ASA Annual Meeting Workshop as well as APSF Newsletters and Presentations. The 2019 Pierce Lecture was given by Jeff Cooper and focused on the culture of safety as well I will include a link to the presentation in the show notes. It was published in the February 2020 APSF Newsletter and we reviewed this on the podcast back in Episode #6. If you haven’t listened to that episode yet, I hope that you will check it out as soon as this show is over to learn more about healthy relationships between surgeons and anesthesiologists and how this helps to build and maintain a culture of safety. This is also an important area for current and future research and the APSF has supported research grants in this area. Check out the show notes for a link to the grant recipient page.

Now, it’s time to get into the article and I will include a link to the article in the show notes. We’ll start with the summary and a case presentation before hearing from one of the authors.  The authors tell us that requirements for creating and maintaining a patient safety culture include the following: safe standard operations within the healthcare organization while promoting speaking up for safety and encouraging reporting of patient harm events through a structured process. Ultimately, this process benefits not just the patients, but also all members of the healthcare team and the organization. The role of the anesthesia professional is vital. We cannot just sit behind the drapes.

Let’s look at an example from the article. The culture of safety is entwined with appropriate reporting of adverse events…you cannot have one without the other. I’m going to read the case from the article.

“It is Friday evening and you are preparing to hand off a femoral-popliteal bypass case to the night team when you receive a page from your trainee that the “heparin isn’t working.” You proceed to the room and learn that your trainee has given 5,000 units of heparin per surgeon request with a resultant rise in the activated clotting time (ACT) value from 121 to 128. The surgeon requests an additional 3,000 units be given and a second ACT returns at 126. Reviewing the situation, you notice an opened vial of tranexamic acid (TXA) on the anesthesia cart. You inquire about the vial, and the trainee acknowledges that he accidentally swapped (TXA) for heparin. The surgeon, who had not overheard your conversation, asks your opinion as to why the ACT has not risen. How do you answer? Should the case continue? Should this event be disclosed to the patient? If so, when should the disclosure occur and who should be present? What support is available for care team members affected by this event?”

Have you ever been in a situation like this? What did you do? Did you feel safe? Did you feel safe and supported while working to keep the patient safe or threatened and unsupported. The answers to these questions likely depend on culture of safety at your institution.

I reached out to Chris Cornelissen, one of the article authors to contribute to the article. I will let him introduce himself.

[Cornelissen] “Hi, my name is Chris Cornelissen and I am an associate clinical professor of anesthesiology at western university of the health sciences and an anesthesiologist with anesthesia service medical group in san Diego California.”

I asked him why he wrote this article. Let’s take a listen to what he had to say.

[Cornelissen] “We wrote this article to share how anesthesia professionals can support a culture of safety, speaking up and enhancing patient-centered care even when events don’t go as we would hope. Ensuring transparency, accountability, and sincerity are so critical in maintaining our relationships with patients and families when an unfortunate event or outcomes takes place. The steps we as anesthesia professionals take in the immediate aftermath of an adverse event are so important because once events are disclosed to a patient or an apology is made or in some cases not made, it’s very hard to go back and retell the narrative. Another important part of disclosure that we aim to highlight is the critical role of caring for the providers involved in the adverse event sometimes called the second victims. We’ve learned that there is a role for peer support programs that can help all members of the team involved in an adverse event to maintain resilience, coping strategies, and learning from mistakes to promote a culture of safety and continuous learning.”

Thank you, Cornelissen for your insight and we are looking forward to hearing more from Cornelissen towards the end of the show.

Let’s look at the intersection between culture of safety and adverse event disclosure. First, what is a culture of safety. This involves the individual and the overall group attitudes, competencies, and patterns of behavior that reveal shared values and demonstrate a commitment to quality medical care and patient safety which is evident in actions and not just articulated in mission statements or at important meetings. How do you know if you are at an institution with a culture of safety? At these places, healthcare professionals will not be afraid to discuss near misses, errors, and patient harm since the environment supports disclosure so that everyone can learn from past experiences to help prevent future errors and improve patient care. According to the Agency for Healthcare Research and Quality or AHRQ, there are 4 key features that are found in an established culture of safety:

  1. Recognition of the high-risk nature of health care with a commitment to “achieve consistently safe operations”
  2. A blame-free environment where individuals can report errors or near misses without fear of reprimand or punishment
  3. Teamwork across ranks and disciplines to address patient safety problems
  4. Commitment from the organization to provide resources to address safety concerns.

This is also something that is part of the Joint Commission accreditation with the requirement for a safety program with a system for reporting adverse events and near misses. With this talk of reporting adverse events and near misses, it is also important to talk about when we need to disclose these events to our patients. Disclosure to the patients is indicated in the following circumstances:

  • First, when the adverse event has a noticeable effect on the patient that was not previously discussed with the patient as a known risk of the procedure or medication
  • Second, when the patient requires a change in care due to the adverse event
  • Third, when there is a risk to the patient’s health in the future due to the adverse event
  • Fourth, when the adverse event leads to providing a treatment or procedure without the patient’s consent

Anesthesia professionals have been focused on patient safety for a long time and despite working hard over the years to improve processes, medications, technology, and equipment, there continue to be threats to patient safety during anesthesia care and this is really when we must step up to work towards the future when no patients are harmed during anesthesia care. It is not enough to just remain vigilant to prevent adverse events, but we also need to know what to do when adverse events or near misses occur so that we can learn from these events and make future anesthesia care safer. The first step is the disclosure of the facts of the event followed by a review of what happened, followed by sharing this knowledge with the patient, and working with the healthcare institutions quality improvement process. This process may be helpful for those involved in the adverse event as well as the patient since the patient can see what is changing and improving as a result of the event so that it will not happen again. It may be one of the most difficult conversations to have with a patient and their family, the disclosure of an adverse event. It is important to include the known facts, express regret for what happened, and provide additional information over time when needed. The American Society of Anesthesiologists Manual on Professional Liability provides the elements of an effective disclosure of a medical error. Another resource is the APSF which has an adverse event protocol that anesthesia professionals can use after an adverse event occurs. I will include a link to these resources in the show notes.

Now, let’s go through the recommended steps to an effective disclosure. Remember, that the leader for the disclosure will usually be the healthcare professionals who was most centrally involved with the event. For adverse events related to the anesthesia care, the involved anesthesia professionals will need to be present at the initial disclosure and may even lead the disclosure process. The first discussion with the patient and family is so important because that is what patients and family often remember.

The preparation prior to the actual disclosure may include the following: Review the event with the involved parties, plan out what you will discuss with the patient and family in advance, utilize a quiet and private location, offer additional support with language interpreters, social workers and clergy may also be present, and ensure that all involved parties are present at the initial disclosure. For the delivery of the disclosure, here are some important elements to consider: Use compassion and make sure there is plenty of time for the disclosure so that it is not rushed, be transparent and explain the conditions under which the medical error occurred, be objective and discuss what you know and just as importantly what you don’t know, make sure that the patient and family understand your explanation, and describe the next steps for investigation and quality and performance improvement. You may want to consider including an apology for confirmed medical errors. Finally, the steps for follow-up may involve frequent updates to the patient and family depending on the event, make sure that you are accessible to the patient and family if needed, and facilitate conversations between risk management, the hospital, and the patient and family after the event and initial disclosure. Does your institution have staff with special training for adverse event disclosures who can help with planning, communication, and follow-up?

As you can see from the steps that I just reviewed, disclosure of an adverse event is a process and not a one-time event and the success of this process depends on being empathetic and caring to the patient and their family who may be suffering while not offering opinions or blaming others. Keep in mind that most states have legal statutes that protect medical professionals who apologize from being used as evidence of being at fault in case of a lawsuit following an adverse event. There may also be institutional policies at your institution that can serve as a guide. Anesthesia professionals may also turn to their physician practice groups, insurance carriers, and legal counsel for guidance on medical malpractice and insurance requirements.

There are formal disclosure models that may be adopted into practice. For example, the Veterans Health Administration has a three-tiered protocol with a provider-driven clinical disclosure, hospital-driven institutional disclosure, and an enterprise large-scale disclosure. Another model is the Defense Health Agency which created the Healthcare Resolutions Program with clinician education prior to adverse events even occurring, real-time event coaching, and a network of peer-support. Another model is the Communication and Optimal Resolution or CANDOR process which offers a framework for hospitals to respond to unexpected adverse events. There is even a checklist that can be used during the disclosure process which I will include a link to in the show notes. Communication and Resolution Programs provide a way for larger healthcare organizations to offer patients compensation following certain adverse events and the organizations that do this have seen positive results with increased reporting of adverse events with no increase in legal claims or costs, but this can be challenging for independent providers.

The authors write about the negative impact on the healthcare professionals when their patients experience harm due to an adverse event that has been shown in several studies. Structured peer support and debriefing may be beneficial for psychological recovery and improved resilience following adverse events. Another benefit of peer support is to prevent continued negative effects on the healthcare professional’s ability to perform following the adverse event.

To conclude the article, the authors tell us what happened in the initial clinical care. There was an immediate disclosure to the surgeon with discussion about how to best proceed. After the surgery when the patient was ready, the event was disclosed to the patient with all involved parties present at the initial disclosure and the patient was able to understand what happened surrounding the event. Risk management was notified of the event and provided support for the disclosure process. The provider received appropriate counseling following the event and the anesthesia professional invited the patient and family to reach out if they had any additional questions.

So, what does the future of culture of safety and adverse event disclosures look like? I asked Cornelissen and this is what he had to say:

[Cornelissen] We’re hoping that as anesthesia professionals play a leading role in establishing and maintaining patient safety initiatives and developing a robust culture of patient safety in our hospitals and operating rooms. We may also appreciate that adverse event disclosure is a team effort. Though we all practice in many diverse settings, from private practice to academic to federal and county institutions and ambulatory surgery centers, we all share a common interest to develop trust with our patients to truthfully disclosure adverse events when they occur and to take care of our colleagues who have been involved with these unfortunate cases. I hope all institutions may take pause to ensure specific disclosure guidelines and peer support programs may be created and be made available to all staff to guide them in disclosure should it be needed.

[Bechtel] Thank you, Cornelissen. This is a vital area for anesthesia professionals who are committed to patient safety. Going forward it is so important to develop and maintain a culture of safety with a disclosure process that is patient-centered and utilizes empathetic and clear communication between all involved parties and the patient and their family and don’t forget about peer support programs and counseling resources for the involved healthcare professionals to aid recovery and build resilience.

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.  There is much more patient safety news and articles in the February 2021 APSF Newsletter that is available online now and we’ll be discussing some of the featured articles on upcoming shows. If you are enjoying listening to this podcast, please take a moment to rate us and leave us a review. Plus, you can find us on twitter and Instagram!  See the show notes for more details and we can’t wait for you to tag us in a patient safety related tweet or like our next post on Instagram!! Follow along with us for anesthesia patient safety pictures and stories!!

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

© 2021, The Anesthesia Patient Safety Foundation