The Case

A first-year orthopedic surgery resident was consulted to aspirate fluid from the left ankle of a patient in the intensive care unit. The resident, accompanied by a second resident, approached the wrong patient, obtained consent from the patient’s wife via telephone, and inserted the needle into the patient’s right ankle. At this point, a third resident entered the room and stated that it was the incorrect patient. The procedure was immediately terminated, and the needle was withdrawn. The patient and family were notified of the error. The patient did not develop any negative sequela as a result of the aborted procedure.

Root cause analysis revealed that the patients were two beds apart in the same unit. The patient was not competent to provide informed consent. The patient’s wife affirmed the patient’s name, which was incorrect, and consented to the procedure. The time out was done with the two residents and the bedside nurse and did not include verification of the patient and procedure location. The nurse questioned why an ankle aspiration procedure was being done on a patient who had wounds on both feet and osteomyelitis in his left foot. The resident responded that the aspiration was to collect fluid, not to treat osteomyelitis. One of the residents stepped away to confirm the patient’s identity in the electronic health record and returned confident that they were working with the correct patient. The nurse’s concern was not resolved, but the resident did not understand the requirements of the time-out, including confirming the patient, procedure and site. As a result, the procedure was initiated.

The Commentary

By Alyssa Bellini, MD and Edgardo S. Salcedo, MD, FACS

Background

This case represents the incidence of two “never events”. The joint aspiration was performed on the wrong patient and on the wrong side. The case highlights the importance of a proper time out and appropriate communication among all team members. A proper time-out includes identifying the patient, indicating the procedure and the site with confirmation and agreement from all team members. When a team member questions any aspect of the time-out, full resolution is required prior to continuing. Thankfully, there were no negative sequela in the presented case, but in other cases of this type, the outcomes may not be as favorable.

What is a “Never Event”? Wrong Patient and Wrong Side

A “never event” is defined as adverse event that is distinct, serious, and usually preventable. Recognizable examples include performing surgery on the patient’s wrong side or administering the wrong blood type in a transfusion. The term was first used by Dr. Ken Kizer, the former CEO of the National Quality Forum (NQF).¹ Although a recent systematic review identified 125 unique “never events,” the most often cited list from the NQF includes 7 categories of “never events” encompassing 29 specific types. “Never events” are usually rare occurrences. Wrong site or wrong patient errors, as in the case above, reportedly occur in approximately 1 in every 113,000 surgical procedures. Procedures performed outside the operating room are not included, so the nationwide count of these errors may be significantly higher than suggested by the estimate above.

A sentinel event is defined as a “patient safety event (not primarily related to the natural course of a patient’s illness or underlying condition) that reaches a patient and results in death, severe harm (regardless of duration), or permanent harm (regardless of severity).² Never and sentinel events often suggest the presence of deficiencies in a health care organization’s current policies and procedures. However, “surgery or other invasive procedure performed at the wrong site, on the wrong patient, or that is the wrong (unintended) procedure for a patient” is considered a sentinel event by The Joint Commission, regardless of the magnitude or duration of the outcome. Never and sentinel events often suggest the presence of deficiencies in a health care organization’s current staffing, equipment and facilities, culture of safety, or policies and procedures.

Sentinel events are considered generally avoidable with the implementation of quality improvement measures.³ Current policies emphasize developing and implementing a comprehensive corrective action plan after each sentinel event.⁴ Accordingly, health care organizations have put considerable energy into creating prevention systems for wrong site and wrong patient surgery, such as surgical safety checklists. In 2003, The Joint Commission implemented the Universal Protocol which includes a “safe surgery checklist”.⁵ Surgical safety checklists offer three distinct safety stops – pre-procedure, sign in, and time out.⁶ These checklists should be utilized prior to performing any surgery or bedside procedure.

Since 1995, The Joint Commission has recommended that hospitals report all sentinel events and mandates the performance of a root cause analysis. A root cause analysis helps to determine what went wrong and what could be improved upon moving forward. The main causes of “never events” in surgery are communication failures, lack of situational awareness, fatigue, lack of healthcare professionals, and large surgical caseloads.⁷ In this case, contributing factors also included the patient’s inability to provide consent, the unavailability of knowledgeable family members, the lack of a clear handoff (with appropriate explanation) to the covering resident, and the absence of clear documentation of the planned procedure in the electronic health record.

After a “never event” occurs, clear and explicit disclosure to the patient and/or their family, as in the current case, is essential. Key themes identified by a systematic review exploring the best course of action after adverse events for patients and their families include clear communication, support and a complete apology.⁸ “Never events” should also be reported to a public agency to aid in accountability and improve the quality of care. By 2008, 26 states had adopted some type of mandatory reporting program for hospital adverse events, including wrong site and wrong patient procedures.⁹

Proper Time-Out Procedure

Time-outs are planned periods of quiet and interdisciplinary discussion focused on ensuring that key procedural details have been addressed. They are performed before nearly all invasive operations or procedures, and must include confirmation of patient identification, surgical procedure, site, and other key aspects of the procedure. All team members must participate without distraction and all are empowered to speak up about any concerns. Time-outs are easily performed, cost almost nothing, and have a mean duration of 36 seconds.¹⁰ A time-out should consist of confirming the correct procedure is planned on the correct body part with the correct patient. If all team members are in agreement, then the procedure can proceed. However, any discrepancy requires the team to pause and reconcile the issue prior to beginning. There are expanded time-outs that include more extensive information depending on team needs and clinical circumstances.^11,12 Proper time-out procedures are an integral part of safe team interactions. A root cause analysis of “never events” occurring in the VA system between 2010 and 2017 found that inadequate time-outs were the most often identified root cause contributing to wrong patient, wrong side, wrong site, or wrong procedure cases (28%), followed by structural or human factors and equipment issues.¹³ The study highlights that all team members should take the time-out procedures seriously.

TeamSTEPPS Framework

Team Strategies and Tools to Enhance Performance and Patient Safety, or TeamSTEPPS, is an evidence-based framework developed to aid healthcare teams to improve team performance. TeamSTEPPS, developed by the Agency for Healthcare Research and Quality (AHRQ) with the Department of Defense, consists of four core teachable competencies: communication, team leadership, situation monitoring, and mutual support. It addresses each of the four skills and how they interact and provides actionable ways for teams to improve their performance. The training kit provided to healthcare teams is flexible and tailored to the healthcare setting including didactic, case scenario and simulation training resources.¹⁴ A 2020 systematic review found that teams that implemented the TeamSTEPPS program experienced improvement in non-technical skills like teamwork, communication and safety culture.¹⁵

The first teachable skill is effective communication, where information is exchanged among team members. The SBAR or Situation, Background, Assessment, and Recommendation/Request tool represents a useful starting point to ensure that team communications are thorough and contain all necessary information. Closed-loop communication, voicing back instructions and receiving confirmation, is recommended to assure that all messages have been correctly received. The second skill is team leadership, focusing on maximizing every team member's potential, which is particularly important in the hospital where multiple teams care for each patient. TeamSTEPPS highlights the importance of keeping all team members aware of plans and maintaining space for any feedback or questions. The third skill is situational monitoring, which is the responsibility of all team members. A helpful tool for situational monitoring is STAR: Stop, Think, Act, and Review. The last skill is mutual support where all team members help one another, provide feedback, and speak up assertively if patient safety is threatened. A tool for speaking up is CUS - “I am Concerned, I am Uncomfortable, this is a Safety issue.” In cases such as the one presented here, team members should use “The Two-Challenge Rule” to state a concern and to ensure the concern is acknowledged and understood. If the concern is not resolved, it should be restated, and then escalated by engaging other team members or going up the chain of command.¹⁶

The “Second Victim”: Impact on Healthcare Providers

Despite system changes to prevent medical errors and “never events,” they will likely continue to occur. The patient and their families are the main victims of medical errors, but any healthcare provider involved in the event may become a “second victim”.¹⁷ Although this concept is somewhat controversial, being involved in an adverse event can cause emotional or physical distress, including burnout, depression, and poor work performance. Potential solutions are to provide counseling, to create a “safe place” to learn from mistakes without the fear of retribution, and to focus on how the system can be improved instead of blaming the individual.¹⁸ Taking steps to mitigate the harmful effects on healthcare providers is an important step in improving staff morale, which improves patient care in the long term.

Summary

In conclusion, this case illustrated the importance of a proper time-out and making sure all team members are on board with the patient plan. TeamSTEPPS provides a helpful framework for creating effective teams focusing on communication, leadership, situational monitoring, and mutual support. When “never events” occur, as in this case, it is important to disclose the error clearly, support the patient and family, and assist the medical team to prevent long-term adverse consequences like burnout or depression. The risk of medical errors may not be reduced to zero, but it is possible to decrease the risk and manage the harmful aftereffects.

Take Home Points

• A “never event” is an adverse medical error that is serious and usually avoidable, such as performing a procedure on the wrong patient or wrong body part. It is expected that hospital staff perform a root cause analysis when such events occur, clearly disclose the error to the patient and their family, and sincerely apologize.
• Time-out procedures are designated time periods prior to invasive operations or procedures where the team confirms the correct procedure, site, and patient. All team members should participate and give their agreement, prior to starting the procedure.
• TeamSTEPPS is an evidence-based framework that has been developed to aid health care teams for optimal team performance and patient care. It consists of strategies for effective communication, leadership, situational monitoring, and mutual support.
• When “never events” or sentinel events occur, the impact on the health care providers should be taken into account and steps taken to support them through the aftermath.

Alyssa Bellini, MD
Resident Physician
Department of Surgery
UC Davis Health
arbellini@ucdavis.edu

Edgardo S Salcedo, MD, FACS
Professor
Interim Vice Chair of Education
Program Director, General Surgery Residency
Program Director, Surgical Education and Simulation Fellowship
Department of Surgery, Division of Trauma, Acute Care Surgery & Surgical Critical Care
UC Davis Health
esalcedo@ucdavis.edu

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