The Case

A 58-year-old man with a history of type 2 diabetes mellitus, hypertension, morbid obesity, atrial fibrillation, and a thoracic aortic aneurysm presented to the Emergency Department (ED) after a syncopal event and fall, with rapid ventricular response. Computed tomography (CT) of the head and cervical spine was negative. CT angiography of the chest and abdomen showed a 5.6 cm thoracic aortic aneurysm without obvious dissection, but there was a pericardial effusion suggesting possible hemopericardium. He was started on an infusion of labetalol and transferred to a regional referral center. He was seen shortly after arrival by a cardiac surgeon, who was concerned about the earlier CT findings and ordered a repeat CT angiogram of the chest (two hours after arrival) that showed progression to an acute dissection of the ascending aorta, a life-threatening emergency. The cardiac surgeon discussed the problem with the patient and his wife, including the numerous risks of surgery. Less than two hours after the repeat CT scan, the patient was taken to the operating room (OR) to undergo open replacement of the aortic valve, aortic root, and ascending aorta with a composite graft, and reimplantation of the coronary arteries (Bentall procedure with hemi-arch replacement), involving cardiopulmonary bypass and hypothermic circulatory arrest.

The surgery was technically difficult, due to the patient’s advanced disease and extensive dissection, and required prolonged cardiopulmonary bypass time (462 min) and cross-clamp time (295 min). The surgeon did not realize at the time that the bypass time was so long, leading to a short delay in redosing the cardioplegic solution that is used to keep the heart completely still during surgery. After removal of the cross-clamp, the patient was found to have developed “stone heart” due to suspected ischemic injury and was unable to come off bypass. The surgeon briefly discussed the situation by telephone with his cardiac surgery colleagues and then temporarily left the OR to update the patient’s wife on this dismal development. He explained that there was an intraoperative error in failing to protect the heart, but also that the impact of this error was unclear due to the severity of the patient’s underlying cardiovascular disease. The surgeon offered the option of extracorporeal life support to allow family members to see the patient before stopping support. The patient was placed on extracorporeal membrane oxygenation (ECMO) and transported to the intensive care unit (ICU), where the patient’s wife and other family members stayed at his bedside, accompanied by a chaplain and soon by a Catholic priest. Four hours after the patient left the OR, ECMO was discontinued, and the patient died. The surgeon did not follow up with the patient’s wife at that time, having spoken to her earlier.

After this case was reviewed by the patient safety committee several months after the operation; potential areas of improvement were identified. Improved processes of communication related to prolonged bypass and cross clamp times were implemented.  Additionally, the Communication AND Optimal Resolution (CANDOR) process was reviewed, and it was discovered that the CANDOR communication process was not followed in its entirety for the patient’s family members and the staff involved. With support from the risk management team, the surgeon ultimately contacted the patient’s wife some months after his death by telephone to express his sympathy and condolences for her loss. He confirmed that she understood what happened, including the miscommunication among operating room team members that led to a delay in administering cardioplegia, but also the uncertainty about whether this miscommunication caused the patient’s demise. She asked questions about the details of the procedure, which he answered.  She also asked about steps taken to prevent similar problems in the future, and he explained that new Perfusion Service policies were being established to enhance intraoperative communication and situational awareness. She understood and expressed appreciation; the surgeon provided his contact information and invited her to call if she had subsequent questions or concerns. He also offered the support of a grief counselor, which she accepted. Hospital staff then offered confidential peer-to-peer support to the surgeon and others involved in the care of the patient, following routine practice.

The Commentary

By Leilani Schweitzer

The family of a patient who dies is vulnerable no matter the cause of their loved one’s death. The circumstances of the death may be difficult for a family to initially consider, but over time may become more clear, and thus, more concerning. The family’s opportunity to ask questions and to be provided answers by those best able to answer—their loved one’s physicians—is vital to the process of coming to terms with the death not only immediately after the event but later on after the impact of the event has settled in for the family. This additional time also allows the medical team to investigate the causes of the event and to find explanations they can share with the family.

Background

In this case, the patient had multiple comorbidities and was critically ill when he was taken to the OR. His complex health condition was known to his wife, and given the very complex nature of the surgery, the patient was at high risk. However, the surgeon identified an error in the team’s intraoperative care that may or may not have contributed to the patient’s poor outcome. Based on the hospital’s policy of following the CANDOR process, the surgeon took responsibility for this error, initially informed the patient’s wife of the patient’s condition, explained the circumstances as he understood them at the time, and offered to provide external life support (ECMO) to the patient so that the family would have time with the patient at end of life. However, once the support was discontinued and the patient died, the physician did not do any further follow up with the patient’s wife.

Communication AND Optimal Resolution (CANDOR), is an Agency for Research and Healthcare Quality supported process that provides a structured guideline to assist organizations in responding appropriately and timely to patient harm events. It involves five components including:

1. Identify the unexpected harm event.
2. Activate the system including the team leads trained in response and disclosure.
3. Trained CANDOR leads implement disclosure communication and follow up along with support for the caregiver.
4. Investigate, analyze, and report the CANDOR event within 30-45 days from the event occurrence.
5. Initiate the resolution process, which includes implementing patient safety processes to improve care and prevent harm in the future. Organizations consider how to address harm resolution and consider whether families should be compensated.

A subsequent review by the patient safety committee several months later along with discussion with members of the care team confirmed that there was a miscommunication in the OR that may have played a role in the failure of the heart to start up again after surgery and the patient’s eventual death. While taking responsibility and initially informing the wife of a problem was a positive and appropriate start to the CANDOR process, which this hospital follows, the surgeon fell short of completing  all the CANDOR steps by not following up with the widow after more information was known. Unfortunately, in this case, there was no plan or commitment made to the widow to follow up with her and further explain what was later learned about the surgery, particularly since there remained uncertainty about the factors that contributed to the error and its impact. For example, as described in a recently published article, “the safe use of cardioplegia during cardiac surgery requires a team approach and excellent interprofessional communication. With numerous moving parts encountered during open-heart surgery and the use of the cardiopulmonary bypass machine, it is of utmost importance for physicians, perfusionists, nurses, and surgical assistants to pay close attention and speak up should an issue arise. A designated heart team that practices and works together can make for improved patient safety and better patient outcomes. Closed-loop feedback is used during critical times between the cardiac surgeon and perfusionist to diminish any room for error.”¹ While the team later recognized that new policies were needed to improve intraoperative communication related to cardiopulmonary bypass, this improvement intervention was not shared initially with the wife. Therefore, after fully discussing the case, the committee recommended that the surgeon reach out to the patient’s wife to provide more information along with an apology, which he did.  For the patient’s family, communication from the surgeon is critical to their understanding of the situation and ability to heal. 

In this case, because the surgeon waited several months to explain the patient’s care to his widow and specifically what was later found during the patient safety committee, she was denied the opportunity to ask questions and potentially gain a greater understanding of her husband’s death in a timely manner, thus further delaying resolution for the patient’s widow. In the weeks closely following the patient’s death, she may have wondered about the facts of his care, possibly misinterpreting what happened, placing blame where it did not belong, or feeling she held some responsibility for the outcome.² All of these possible reactions would be damaging to the widow’s efforts to adjust to life without her husband.³

Approach to Improving Patient Safety

Implementing the CANDOR process

Ideally, all the steps in the CANDOR process should be followed in cases like this one. Immediately after the surgery, the Risk Management team should have been notified of the surgical outcome and should have been involved in documenting disclosure in the medical record. The resulting note in the medical record would identify who attended the meeting about the surgical outcome and the facts discussed. At that point, peer support for the involved clinicians should have been triggered and the family should have been connected to a single point of contact (liaison) who would stay in touch with the widow to understand her needs, connect her to bereavement care, and update her on next steps. Additionally, following the third component of the CANDOR Process—Response and Disclosure—a letter expressing condolences for the patient’s death and setting expectations for further discussion should have been sent to patient’s wife.

Once the initial disclosure documentation process was completed, a review should have been conducted to determine: 1) whether the surgery met the Standard of Care, and 2) what the consequences for the widow would be (as per Step 4 of the CANDOR process: Investigation and Analysis). While the review was underway, the liaison should have stayed in touch with the widow to understand her concerns and to answer any questions she may have had, if possible. It is also helpful for the liaison to set expectations for surviving family members so they can prepare for what will happen next. As the quality and safety review and determination of a settlement offer take a significant amount of time, it is helpful to explain to a patient’s loved ones that the review will likely take several months to complete.

If all the details of the care given to the patient are not yet known at this time, the liaison should also explain to the widow what will be done to complete the investigation. For this case, that could involve answering the following questions: Was there a technical error during surgery that led to prolonged cross-clamp and cardiopulmonary bypass time? Or was the aneurysmal dissection so severe that even the most skilled surgical team would have been unable to complete the operation without irreversible myocardial injury? The family should also be reassured that a root cause analysis (RCA) will be carried out to determine exactly what happened and why. It is additionally helpful to explain that some components of the review process—those pertaining to peer review—are necessarily kept confidential. Explaining these aspects of the review process, i.e., the confidentiality requirements of the peer review process, avoids family members being surprised to learn that some materials are not available to them.

Dealing with issues of compensation

While an error in communication did occur in this case, it likely did not cause the patient’s death. If this assumption was verified by the review process and RCAs, the following details related to an offer of compensation would not be applicable to this case but would be important when considering the impacts of preventable medical harm events on patients and families in other cases.

If an offer of compensation is appropriate, possible liens issued from the US Centers for Medicare & Medicaid Services (CMS), sometimes referred to as ‘recovery claims’, need to be understood.^4,5 This is particularly important if the patient was a Medicaid or Medicare recipient. Details about the recovery claim are provided in a conditional payment letter from CMS. In these matters, the issue is not whether any medical error occurred, but that whether payment to the beneficiary (or their estate) is being considered for services for which Medicare has already paid the hospital.⁶ It is in the family’s interest in these types of cases to be aware of potential liens before agreeing to a settlement.⁷

The patient’s working status is also important to understand. What was the patient’s work status when they died? If the patient’s income was supporting their family, the family may have a right to that lost income. The family should provide tax documents to illustrate this potential component of compensation to the legal team. Additionally, if the patient had been working prior to their death, their likely life expectancy is also a relevant component of any compensation amount. This information, while delicate in nature, is important for fully understanding the consequences of the patient’s death and therefore determining appropriate compensation. The liaison should explain this to the patient’s loved one(s), gather the necessary information, and share it with the hospital’s claims or legal team.

Sharing review results with the family

No matter the results of the review process, a meeting should be offered to the patient’s family to answer questions and explain improvements made in response to the adverse event, as was done in the case discussed herein. Learning that improvements have been made because of the patient’s and family’s experiences is often important and comforting to patients or their families left behind.

When planning the meeting, the team should be prepared for any questions the family may have. The liaison can inquire about their concerns and other issues ahead of the meeting. For example, in this case, will the widow bring anyone else with her? Who from the hospital will attend the meeting? It is important the widow knows who will be there and what their roles are. At least her point of contact (social worker/liaison), the involved physician(s), a representative of hospital leadership, and a hospital lawyer should attend.

Before the meeting, any compensation amount should be determined and approved, and a plan established to explain the rationale for the amount. The necessary legal documents should be prepared ahead of time and taken to the meeting. It would also be helpful to let the widow know beforehand if an offer of compensation will be discussed and whether she will be required to agree to specified terms within a specific time limit. There should be no surprises for her or anyone else involved. Encourage her to have the document reviewed by an attorney before signing it but inform her that she should not sign the document at the meeting.

At the beginning of the meeting, after introductions, all non-family attendees should offer their apologies and condolences for the loss of the patient. After that is a good time to ask the widow to tell the attendees about her husband as they likely know what happened to him clinically, but they may not know him as a person. Then ask her what she wants to learn from the meeting. This approach can reassure the patient’s wife that her concerns are being recognized and taken seriously. Often the meeting participants who were involved in providing health care have things they feel are important to tell the family, but the family may have entirely different concerns. The AHRQ CANDOR Toolkit has helpful information for staff and family members, including a video demonstrating a disclosure meeting between a care team and the affected family.

The patient’s clinical care should be explained and questions about it answered as extensively as possible during the meeting as well. The lessons learned and improvements made in response to the adverse event should also be explained, as was done during the surgeon's follow-up call to the patient’s wife in this case. The latter explanation is particularly important, as most families want to know that what happened to them will not happen to anyone else.

After the clinical care and recommended improvements are explained, the clinicians involved should excuse themselves from the meeting so that compensation can be discussed. The rationale behind the determined amount should be explained to the widow. If CMS recovery claims are expected, this should be explained as well. Be mindful that anything discussed after the compensation amount is offered tends not to be remembered, so explain important factors and components of compensation that patients/families likely do not understand before stating the dollar amount. If not explained adequately, family members may carry out their own research and reach their own conclusions about a fair settlement, especially after hearing an institution apologize for an event that caused them profound pain, and that could lead them and the hospital down a road to litigation.  

End the meeting with a summary of the information presented but also by taking responsibility. Apologizing without offering amends—fair and thoughtful compensation- may put a significant burden on an already vulnerable, grieving family.

Conclusion

The effective utilization of the CANDOR process can be beneficial to all stakeholders in dealing with the aftermath of an adverse medical event. It should be fully implemented so as to keep a bad outcome from becoming worse.

Take-Home Points

• When patients are harmed and particularly when a patient death is involved, healthcare organizations must identify the harm, take responsibility, and communicate with the family.
• CANDOR is a structure process that organizations may use that offers training and guidelines to support this communication process. Utilization of the AHRQ CANDOR toolkit can be helpful to all stakeholders.
• Following an unexpected harm, health care organizations should employ a trained response team who can support physicians, nurses, and other staff through the process of communicated with families (CANDOR or another harm response process).
• Always share any improvements that were made as a result of the harm experience.
• Some situations may require the healthcare organization to consider compensation to the family.

Leilani Schweitzer
Assistant Vice President, Communication and Resolution
Stanford Medicine
 

References

1. Carvajal C, Goyal A, Tadi P. Cardioplegia. [Updated 2022 May 1]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. [Free full text]
2. Bell S. Addressing the long-term impact of patient harm. The Institute for Healthcare Improvement (IHI). March 2019. Accessed August 28, 2024. [Free full text]
3. Battles JB, Reback KA, Azam I. Paving the Way for Progress: The Agency for Healthcare Research and Quality Patient Safety and Medical Liability Demonstration Initiative. Health Serv Res. 2016;51 Suppl 3(Suppl 3):2401-2413. [Free full text]
4. Attorney services. Centers for Medicare and Medicaid Services (CMS). [Available at]
5. Beneficiary services. Centers for Medicare and Medicaid Services (CMS). [Available at]
6. Medicare’s recovery process. Centers for Medicare and Medicaid Services (CMS). [Available at]
7. Helland E. The role of health care liens in litigation and recovery. Santa Monica, CA: The RAND Corporation; 2018. [Free full text]