The Case

A 52-year-old woman with no significant past medical history presented to a multidisciplinary breast clinic with a left-sided breast mass that was incidentally found on routine screening mammography. Diagnostic work up with ultrasound-guided biopsy led to a diagnosis of ductal carcinoma in situ (DCIS). A lumpectomy procedure with lymphoscintigraphy and sentinel lymph node biopsy (SLNB) was scheduled. A Magseed (5 mm sterile surgical steel rod) was inserted into the lesion using ultrasound guidance to help the surgeon localize the non-palpable mass during surgery. The patient was informed where and when to arrive for her procedure, and what steps to take before arriving. On the day of surgery, the patient was met in the pre-operative unit by several different provider teams to help prepare her for the lumpectomy with lymphoscintigraphy and SLNB.

In the pre-operative unit, the patient was assigned a nurse who recorded her demographic information, verified the procedure, and confirmed her medical history. Per protocol, the resident physician greeted the patient and initialed the left breast with a marker to verify the site of surgery. The attending physician stopped by to answer questions and to confirm that the procedure was running on schedule. The anesthesiology team prepared the patient for surgery according to their own protocol and rolled her to the Operating Room (OR).

In the OR, the surgical team (circulating nurse, surgical technician, anesthesiologist, attending and resident surgeons, and medical student) prepared the patient for surgery. Two separate time-outs were performed while the patient was being prepped, placed under general anesthesia, and draped. After the final time-out, the attending began operating. She tried localizing the Magseed as well as the expected Technetium-99 radiotracer dye, but quickly learned that no radiotracer dye had been injected for the SNLB – a key process step that was supposed to have occurred prior to the surgery. The nuclear medicine team never saw the patient preoperatively, and none of the staff members or teams realized this until the patient was under general anesthesia with an open incision. Subsequent investigation uncovered that the patient was properly scheduled on the nuclear medicine calendar, showing that the error could have been avoided if someone had discussed with the patient her attendance or someone from the surgical team team had called nuclear medicine before sending the patient to the OR. The attending physician decided to continue the operation without the radiotracer dye, given the practical difficulty of calling the nuclear medicine team urgently into the OR.

Fortunately, in this case, the sentinel lymph node was able to be localized even without the radiactive. However, the patient was put at risk for an adverse event that could have affected the outcome of her care and diagnosis. For example, if the sentinel lymph node was not correctly identified and instead a distant lymph node was sent to pathology, a lymph node metastasis may have been missed. Furthermore, the patient would have had a higher risk of lymphedema if a complete axillary lymph node dissection needed to be completed as a result of this error.

The Commentary

By Candice Sauder, MD, MS, MEd, FACS and Kara T Kleber, MD, MA

Ductal carcinoma in situ (DCIS) is a type of pre-invasive breast lesion that theoretically does not have the ability to spread outside of the breast, since the malignancy is contained within the milk ducts; yet approximately 25% of lesions are found to have an invasive component upon full excision.^1,2 However even knowing the above data, in the United States concurrent lumpectomy and sentinel lymph node biopsy (SLNB), without prior confirmation of invasive carcinoma on biopsy, is not consistently recommended based on numerous large trials.^3-5 This is an important discussion point as each part of a procedure brings associated risks, which for sentinel lymph node biopsy are not negligible. These include anaphylaxis, hematoma, seroma, and a 5-9% risk of lymphedema.⁶ Additionally, the lack of use of a dual tracer (Technicium-99 radiotracer and blue dye) decreases the surgeon’s ability to find the correct sentinel lymph node(s) and increases the false negative rate which can lead to inappropriate treatment.⁷

Approach to Improving Safety & Patient Safety Target

As noted here, breast surgeons, and surgeons in general, often perform multiple procedures concurrently. There are often several different teams working together to provide care for the same patient at the same time, especially since cancer care is very multidisciplinary. Many of these procedures are aided by physicians in other specialties, such as nuclear medicine in this case, and these additional procedures are typically performed at a site distant from the operative theater. This case demonstrates how this overlapping care can lead to errors that put the patient in high-risk situations, overall impacting their health and quality of care.

Hospitals should consider creating, and many have, an overarching pre-operative checklist for patients requiring surgery. Checklists have been repetitively demonstrated to be effective at reducing errors. A very well-known example, Atul Gawande’s “Checklist Manifesto” demonstrated a 19-item surgical safety checklist reduced complications in high-income countries from 9.3% to 6.6%.⁸ Another example from the Veterans Health Administration showed an 18% reduction in annual mortality rate for facilities that participated in their checklist program.⁹ A study published in the Netherlands showed an absolute risk reduction of 10.6 in their post-operative complications.¹⁰ Outside of the operating rooms, checklists are known to reduce central line infections and medical errors.^10,11 These medical pre-procedure checklists should be able to be utilized by anyone but ultimately checklists should be confirmed as complete by the nurse, the physician directly caring for the patient, and ultimately the patient. Considering the case presented, direct verification from the patient that they presented for the expected procedure in nuclear medicine before coming to the surgical area could have been verified by the OR nurse, operating surgeon, or resident. While this may be a simplistic answer, it highlights an oft forgot source of verification – the patient themselves.

Operating room checklists, also commonly known as “time outs”, provide a second opportunity to verify all information. These universal checklists are recommended by the World Health Organization and required by the Joint Commission Universal Protocol, which is the independent governing body responsible for hospital accreditation.^12,13 The Universal Protocol was originally developed in 2004 to prevent wrong side, wrong procedure, and wrong person surgery. Now it includes conducting a pre-procedure verification process, marking the procedure site, and performing a time-out.¹² The pre-operating room portion includes verifying any required documentation, required radiologic reports or test results, and any special equipment required for the upcoming procedure. Confirmation of the radiotracer should have been identified at this step. They also encourage the patient being involved in this process whenever possible, which is why this part of the “surgical case” is done often in the pre-operative area or just after the patient has entered the operative theater and before anesthesia. The official “time out” is done immediately prior to incision after the patient is under anesthesia, therefore making it impossible in most cases for the patient to participate. This involves all persons involved in the care of the patient as the procedure starts, which is important as these personnel may be different than those who did the pre-procedure checklist.

Surgical timeouts are universal in operating rooms; however, there are many multiple procedure surgeries as well. In these situations, not all staff participating in the procedure may be present for the first initial timeout and it is important to have structured communication at this time as well. One such example is breast cancer reconstruction, here procedures are completed in sequence not concurrently. An additional timeout is undertaken prior to a new team beginning ensuring effective, efficient collaboration between the surgical oncologist and plastic surgeon which has a significant effect on outcomes.^14,15

In conclusion, the case was a near miss with a patient placed at increased risk for complications by performing a sentinel lymph node biopsy under less-than-ideal circumstances. In cases where procedures involving multiple care teams, whether in the operating room or because their expertise is required prior to help facilitate an operation, structured communication is important and helps improve outcomes. The often forgotten and most important part of the team---the patient--must be included, as the patient themselves provides the most direct way to verify complete care. Timeout checklists are valuable tools that should be conducted in the presence of an awake patient prior to the induction of anesthesia and should include verification of any necessary pre-operative procedures. 

Take Home Points

• Multidisciplinary teams enhance patient care and improve outcomes but increase the opportunity for communication errors
• Pre-operative checklist protocols should be designed to include confirmation of all necessary pre-operative procedures.
• The completion of any necessary pre-operative procedures should be confirmed with the patient directly as part of the check in process.

Candice Sauder, MD, MS, MEd, FACS
Department of Surgery, Division of Surgical Oncology
UC Davis Health
camsauder@ucdavis.edu

Kara T Kleber, MD, MA
Department of Surgery
UC Davis Health
Ktkleber@UCDavis.edu

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