Clinical Vignette

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?

This clinical scenario provides an opportunity for the anesthesia team to model, through behavior and actions, a culture of safety as it pertains to the disclosure of adverse events. We will review guiding principles of disclosure which may be applied by anesthesia professionals when harmful events occur. We will also examine how a culture of safety serves as the foundation for adverse event disclosure, identify leading practices, and outline resources that facilitate patient-centered disclosure.

How a Culture of Safety Relates to Adverse Event Disclosure

A culture of safety reflects the shared values, commitments, and actions that promote patient safety within an organization. It is the product of individual and group attitudes, competencies, and patterns of behavior that determine the organization’s commitment to quality and patient safety. It is not just what is thought or said, but what is demonstrated by behaviors and actions.¹ In work environments with a robust culture of safety, there is no fear in discussing near misses, errors, and patient harm, but rather there exists a supportive environment to learn from experiences with the goal of preventing errors and improving care for future patients. The Agency for Healthcare Research and Quality (AHRQ) highlights the following four key features that define a culture of safety:²

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.

The Joint Commission, which accredits health care organizations throughout the United States, requires that health care facilities create a safety program that promotes reporting adverse events and near misses and learning from them.³ Disclosure to the patient is required when the adverse event 1) has a perceptible effect on the patient that was not discussed in advance as a known risk; 2) necessitates a change in the patient’s care; 3) potentially poses an important risk to the patient’s future health, even if that risk is extremely small; 4) involves providing a treatment or procedure without the patient’s consent.²

Anesthesia Care and Disclosure within a Culture of Safety

Anesthesia professionals aspire to minimize risk, prevent harm, and learn from errors. This prinicipled mindset has helped establish anesthesia professionals as leaders in patient safety.⁴ However, in complex systems, errors and harm will continue to occur despite our best efforts. When an error does occur, it is imperative that we respond in an equally principled manner. This includes disclosing what is known, committing to a thorough review, and sharing what is learned with our patients, while being mindful that all organizational quality improvement protections are adhered to. With this process, patients come to understand that the organization learned from their experiences and that conclusions drawn from the review will lead to reforms that support the “learning culture” emblematic of a safety culture.¹

Multiple articles in the patient safety literature have highlighted essential elements of disclosure to patients and their families. Suggested elements of the disclosure conversation include describing the known facts, expressing regret for what occurred, and letting patients and families know that as information becomes available, they will be kept fully informed.⁵ The American Society of Anesthesiologists (ASA) Manual on Professional Liability has summarized key components needed for an effective disclosure of a medical error; these are summarized in Table 1.⁶ The Anesthesia Patient Safety Foundation (APSF) has also developed an adverse event protocol for anesthesia professionals and perioperative care team members to utilize following an adverse event.⁷

Table 1: Summary of the Key Components for an Effective Disclosure of a Medical Error.

Preparation

Review the event with the involved parties.

Plan your discussion with patient or family in advance.

Select a quiet and private location for the discussion.

Offer language interpreters, social workers, and clergy to be present.

Have all involved parties at the initial disclosure.

Delivery

Deliver a compassionate and unhurried explanation.

Explain the conditions under which the medical error occurred.

Discuss objectively what you know and don’t know.

Verify that the patient and family understand your explanation.

Describe the process for investigation and performance improvement.

Consider incorporating an apology for confirmed medical errors.

Follow-up

Provide frequent updates to the patient and family.

Make yourself easily accessible to the patient and family.

Facilitate discussions between risk management, the hospital, and the patient or family.

Table 1 on page 15 of the ASA Physicians Series, Manual on Professional Liability is reprinted with permission of the American Society of Anesthesiologists, 1061 American Lane, Schaumburg, IL 60173-4973. © November 2017
https://www.asahq.org/standards-and-guidelines/~/media/9bd16ced606247a19d31aa15236f842f.ashx

Disclosure is a process, not a single event. An empathetic expression of caring along with ongoing communication with the patient and family are foundational to successful disclosure of adverse events. Many states have adopted statutes protecting apologies and other benevolent gestures from being used as an admission of fault in the event of a lawsuit.⁸ In addition to conveying empathy, the anesthesia professional should avoid speculation and resist any impulse to point fingers at other clinicians.Once it is determined that event disclosure with the patient should take place, it is important that any anesthesia professionals involved in the event collaboratively discuss with the surgical and nursing teams what is known, what remains unknown, and what steps will follow. It is ideal for the provider most centrally involved with the event to lead the discussion with the patient. Multiple specialties may need to be involved. The discussion should be rehearsed and provide a genuine and open explanation of events using terms that are understandable to the patient. Transparent communication is based on available facts and not speculation. Some institutions employ staff specifically trained to assist with disclosure and they can play a vital role in communication with patients and families, especially on an ongoing basis. Consideration should be given to consulting with these resources prior to disclosure. Throughout this process, it is imperative that all health care team members are aware of and follow their institutional policies that guide disclosure. Physician practice groups that provide services within hospitals may also have specific guidelines to follow based on medical malpractice and insurance requirements. Furthermore, each practice setting may have specific reporting requirements for anesthesia professionals. Hospital-employed physicians should seek input from legal resources offered by the facility whenever possible. Similarly, members of independent groups and solo practitioners should consult their insurance carriers and legal counsel who represent their interests. When the adverse event is directly linked to the anesthetic care, it is critical that the anesthesia professionals are present at the initial disclosure to the family and patient. The initial discussion and relay of information provided to the patient and family is one that will be remembered and, therefore, all of the facts should be conveyed in an accurate and concise manner.

Institutions seeking to build a more robust disclosure program have a variety of established models to consider. These models originated in the public sector as well as in private and academic institutional settings. Realizing that adverse events vary in scope and severity, the Veterans Health Administration developed a three-tiered disclosure protocol consisting of a provider-driven clinical disclosure, hospital-driven institutional disclosure, and an enterprise large-scale disclosure.⁹ The Defense Health Agency, which manages the United States military health care system, created a robust Healthcare Resolutions Program that preemptively educates clinicians, provides real-time event coaching, and supports an extensive peer-support network to assist providers throughout the disclosure process.¹⁰ One of the earliest proponents of disclosure in academia was the University of Michigan, who developed an innovative approach to medical errors and disclosure called the “Michigan Model”.¹¹ In May 2016, the Agency for Healthcare Research and Quality used the “Michigan Model” results along with contributions from others including the University of Washington, the University of Illinois, and MedStar Health to develop the Communication and Optimal Resolution (CANDOR) process.¹² CANDOR provides a framework for hospitals to improve their response to unexpected harm events, including an online checklist to assist providers in the disclosure process (https://www.ahrq.gov/patient-safety/capacity/candor/modules/checklist5.html.)

Through the Michigan Model and CANDOR, which are also referred to as Communication and Resolution Programs (CRPs), organizations may offer patients compensation if they determine care was not reasonable under the circumstances.^13,14 Organizations that have implemented this type of approach have seen a significant increase in incident reporting without an increase in claims or legal costs.^7,13-15 While these are positive outcomes, they may be surrogates for the laudable goals of normalizing honesty and accountability, while cultivating safety as an ethical obligation.⁴ Notably, early adopters of CRPs have been large, integrated health systems that serve as both the medical staff’s employer and insurance carrier.¹⁶ Organizations that contract with independent providers and entities may find it challenging to compensate patients during the disclosure process.

Physicians protected under traditional insurance models are typically precluded from assuming any obligation, making voluntary payments, or incurring expenses for an adverse event without the consent of the insurer. Disclosures made outside the formal peer review process are discoverable during litigation, and all parties involved in adverse events will have an interest in the investigation. This can make it difficult to conduct comprehensive investigations quickly, especially if an adverse event involves multiple providers or the extent of the injury cannot be immediately determined.

Multiple surveys have shown that health care professionals are affected when their patients experience adverse events of harm. This includes emotional distress with potential effects on performance.^17-20 Psychological recovery and resilience may be enhanced with structured peer support, and numerous resources exist for anesthesia professionals to learn about effective peer support programs.^21-23 The Joint Commission acknowledges the importance of peer support to prevent the domino effect that adverse events can have on health care worker performance.²³ Paramount to this process is promotion of a robust patient safety culture for learning from system defects, engaging all team members in a postevent debrief and peer-to-peer emotional support.

Conclusion

The events that followed the clinical vignette illustrate key principles of authentic error disclosure that reflect a culture of safety. The error was immediately disclosed to the surgical team. Discussion and consultation ensued, resulting in a collective decision to proceed. The event was disclosed in clear and unambiguous language to the patient at a time when it could be understood and processed. The error was disclosed by all involved care team members, namely the surgeon, and anesthesia professionals. The risk management team was informed of the event and supported the process. Counseling was provided to the fearful and distraught provider. Lastly, an invitation for ongoing communication was extended by the anesthesia professional to the patient and family should questions arise in the future.

Disclosure by anesthesia professionals should occur in a timely manner, be stated in terms that the patient can understand and should provide the platform for fair and open discussion. This may lead to subsequent conversations with the patient in consultation with risk management or other institutional entities involved in adverse event disclosure. All team members involved in the event must be supported, with numerous peer-to-peer models and disclosure programs available for institutions to emulate.^11,21-23

As stewards and advocates for patient safety, anesthesia professionals play a key role in avoiding patient harm. When adverse events do occur, our response should be as principled as our commitment to patient safety. Paramount to this process is active engagement in patient-centered disclosure, authentic and ongoing communication with the patient and family, team support, and a commitment to process improvement.

 

Christopher Cornelissen, DO, FASA, is an anesthesiologist at Anesthesia Service Medical Group in San Diego, CA, and clinical associate professor in the Department of Anesthesiology at Western University of Health Sciences.

Christopher Call, MD, is an assistant professor in the Department of Anesthesiology at Uniformed Services University of the Health Sciences, Bethesda, MD.

Monica W. Harbell, MD, FASA, is an assistant professor in the Department of Anesthesia and Perioperative Medicine at Mayo Clinic, Phoenix, AZ.

Anu Wadhwa, MBBS, MSc, FASA, is a clinical professor in the Department of Anesthesiology at University of California San Diego, San Diego, CA.

Brian Thomas, JD, is vice president, Risk Management, Preferred Physicians Medical in Overland Park, KS.

Barbara Gold, MD, MHCM, is a professor in the Department of Anesthesiology at University of Minnesota, Minneapolis, MN.

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The authors have no conflicts of interest.

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References

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Disclaimer: The views expressed in this article are those of the authors and do not reflect the official policy of the Department of Defense, Uniformed Services University of the Health Sciences or the U.S. Government. Mention of trade names, commercial products, or organizations does not imply endorsement by the U.S. Government.