The Case

A 65-year-old woman was admitted for evaluation of abdominal pain and weight loss. Based on diagnostic data and imaging, she was found to have a large gastric mass concerning for malignancy. The patient had recently been diagnosed with a deep venous thrombosis, which was being treated with enoxaparin (an anticoagulant). A gastroenterologist was consulted for possible biopsy of the gastric mass. The gastroenterologist planned to perform an esophagogastroduodenoscopy (EGD) with biopsy the following day. This recommendation was not conveyed directly to the hospitalist caring for the patient, although the consultant did document it in his note.

The next day, the patient was scheduled for an EGD as an add-on case. Because the hospitalist was unaware of the plan, the patient was not made NPO (nothing by mouth), nor was the enoxaparin stopped. When the endoscopy suite called for the patient, the bedside nurse said that the patient had just had breakfast, but she forgot to mention that morning dose of the anticoagulant had already been given. Three hours later, the patient was taken to the EGD suite. While performing the preanesthesia checklist, the certified nurse anesthetist documented that enoxaparin had been given that morning, but did not notify the gastroenterologist. EGD was performed and a biopsy was taken from the mass. The patient was observed briefly in the recovery room and sent back to her room on the ward.

Two hours later, the patient developed delirium and looked pale. She was found to be hypotensive and stat labs were sent. Resuscitation with intravenous fluids was started, but within 15 minutes, the patient went into cardiac arrest. The laboratory results showed a sharp drop in her blood count, consistent with postprocedural bleeding. The patient was resuscitated, transferred to the intensive care unit, and received massive transfusions. An angiogram revealed that the bleeding was from the gastric mass. Embolization was attempted but was unsuccessful, and the patient subsequently arrested again. After extensive discussions with the family, the decision was made to focus on comfort measures only. The patient died shortly thereafter.

The Commentary

by Ken Catchpole, PhD

In simple risk management terms, most clinical procedures aim to achieve long-term benefits from treatment by accepting and managing the higher short-term procedural risks. Errors such as the one in this case can be seen as a failure to address the short-term risks appropriately.

In 2009, an estimated 6.9 million esophagogastroduodenoscopy (EGD) procedures were performed in the United States.(1) The American Society for Gastrointestinal Endoscopy classifies the likelihood of bleeding following a procedure as "low risk," where the likelihood of bleeding is less than 1% (such as colonoscopy including biopsies), and "high risk" (such as polypectomy, treatment of varices, tumor ablation, and Endoscopic submucosal dissection), with a 2%–4% expectation of bleeding.(2) Thus, absent the complicating factor of ongoing anticoagulant use, the short-term risks of procedural bleeding in this case was expected to be low.

The patient's recent deep vein thrombosis (DVT) and consequent anticoagulation therapy reduced the thrombotic risk, but increased the risk of postoperative bleeding, possibly by a factor of 10.(3) Following a thromboembolic event, the risk is highest for a recurrence for the first month and diminishes further over the subsequent 2 months.(4) For this reason, where possible, surgery should be delayed for 3 months after such events. In this case, given the recent DVT, the hospitalist and the gastroenterologist should have decided on an explicit strategy for managing periprocedural anticoagulation.

To balance the immediate procedural bleeding risks with the longer term DVT risks, evidence suggests that pausing the anticoagulation therapy during the perioperative period is effective. A final dose of low-molecular-weight heparin given 24 hours before the procedure at half the normal daily dose is associated with a low incidence of major bleeding and no thromboembolic complications.(5) However, adverse drug events associated with anticoagulants occur in about 10% of patients exposed to them (6); 10% of these are associated with a failure to discontinue and 5% to administering the anticoagulant at the wrong time.(7) Of all adverse anticoagulant drug events, 5% were associated with bleeding related to surgery.(7) Thus, careful management of anticoagulation in the perioperative period is essential. For patients in whom ongoing anticoagulation is deemed too risky, other treatment options are available in the perioperative period, such as intermittent pneumatic compression and graduated compression stockings.

In the present case, a series of missed communication opportunities led to a failure to appropriately manage anticoagulation in the perioperative period, which then led to a fatal bleeding event. The formulation and documentation of an antithrombotic plan is seen as a key quality indicator for EGD.(8) The creation of such a plan helps ensure that the appropriate anticoagulation decision for the patient is made, and the timing for cessation and recommencement of antithromboembolic precautions are planned and communicated. This requires the coordination of a number of team members over the 2–3 days of cessation and recommencement.

Passing important information between the care team is difficult to achieve reliably. Important information can be missed in the clutter of details within the electronic health record, especially with complex patients where a provider may not "know what they don't know." Face-to-face or phone discussions can offer opportunities for prioritization and clarification, but they may be challenging to organize. This is why interdisciplinary rounding (9) and preoperative timeouts can be powerful tools for identifying or catching problems before they affect the patient.

To structure important areas of discussion, checklists have proven popular. Checklists have a long and successful history in a range of other industries (10) as a way of ensuring performance-critical tasks are completed. In health care, they are frequently used to help remind teams of important safety, team, or procedural issues to confirm or discuss. They have been shown to be effective in improving safety and perioperative medications management, including anticoagulation.(11) However, the implementation in health care has led to some confusion regarding whether the checklist is a "tick box" exercise or a method to encourage communication.(12) This is because checklists remind the team of what to discuss, but they do not necessarily promote the communication or discussion necessary to be effective. This is why combining checklists with teamwork training may be more effective than either intervention alone.(13) While formal teamwork training may not always be necessary, checklists require that the users have skills and technical knowledge to use them appropriately. Implementation is most successful when physicians lead the process, reflect on, evaluate, and adapt use to fit their practice.(14) In this event, a preoperative checklist was in place and, if used appropriately, could have identified the anticoagulation risk. Unfortunately, the process was not led by a physician and was treated as a "check box" exercise rather than an opportunity for a team discussion; thus, it was ineffective.

Systems safety interventions such as checklists need to be sustained through feedback, reinforcement, and adaptation. Safety processes often compete with efficiency or productivity pressures. The more difficult something is to perform and the less valuable it is perceived to be, the less likely it will be adhered to.(15) When a process is not being properly performed, this must be recognized and addressed through a thorough understanding of the barriers to adherence.(16) Sometimes a process will fall into disuse through lack of feedback or other changes in practice. Surgical safety checklists, like many health care improvement tools, could benefit from regular review and update to address changing threats, challenges, or opportunities.(17,18)

Although the delivery of health care can never be made completely safe, risks can be appropriately managed through individual and team performance and through tasks, technologies, environmental considerations, and organizational approaches to develop, implement, and support a range of communication and coordination tools. This case illustrates how easily failures to discuss risks ad hoc can lead to catastrophic outcomes, and thus it highlights the importance of planning and maintaining formal communication opportunities.

Take-Home Points

• The risks of deep vein thrombosis and postoperative bleeding must be appropriately balanced either by delaying surgery or by appropriately reducing and recommencing anticoagulation in the perioperative period.
• The formulation and documentation of an antithrombotic plan is a key indicator of care quality.
• Multiple communication modes (electronic, phone, face-to-face, rounding, time out) can help ensure appropriate preoperative risk discussions.
• Procedural checklists often require team involvement, rather than just checking the box, to be effective.
• Ideally, physicians should lead the implementation, adaptation, and evaluation of safety checks, which may need regular review to maintain effectiveness.

Ken Catchpole, PhD SmartState Endowed Chair in Clinical Practice and Human Factors Department of Anesthesia and Perioperative Medicine & College of Nursing Medical University of South Carolina Charleston, SC

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