Great progress has been made towards improving patient safety but further work, including applying lessons learned from other high-risk disciplines, will continue to improve the quality of care and decrease the potential for serious medical errors such as wrong-site surgery, says Amanda Budak, vice president of clinical operations, OmniSure Consulting Group.
The term “never event” in healthcare was first coined in 2001 by Dr Ken Kizer, former CEO of the National Quality Forum (NQF), to describe exactly what it implies: an event that should never occur. The NQF originally identified 27 events (now, as of the last revision, 29 events) categorized into groups: surgical, product or device, patient protection, care management, environmental, radiologic, and criminal.
In the surgical category, there are three “W” events: wrong patient, wrong procedure, and wrong site. In a 2009 analysis of sentinel events most frequently reported to The Joint Commission, 13.5 percent of events were related to wrong-site surgery. A 2012 study that reviewed 9,744 closed malpractice claims found that 25 percent were related to wrong-site surgery. During the period of this study, malpractice payments for never events in surgery totaled $1.3 billion, demonstrating the significant financial impact these mistakes can have.
In addition to the cost of malpractice claims, the Centers for Medicare and Medicaid Services (CMS) and many private insurers have adopted policies in which they will not pay for costs associated with preventable errors.
In an evaluation of root cause analyses submitted to The Joint Commission, the following specialties were most commonly involved in wrong-site surgeries:
- Orthopedics: 41 percent
- General surgery: 20 percent
- Neurosurgery: 14 percent
- Urology: 11 percent
- Maxillofacial surgery, cardiovascular surgery, otolaryngology, and ophthalmology: 14 percent
Hospitals and surgeons have made significant strides towards avoiding surgical mistakes such as wrong-site surgery. Strategies include following the Universal Protocol as defined by The Joint Commission.
The Universal Protocol consists of three domains. First, the surgical team should conduct a pre-procedure verification process to verify that it is the correct patient and the correct site. The protocol strongly encourages the surgeon to include the patient in this verification process and have the patient identify the correct site for surgery. Second, the patient and surgeon should mark the intended surgical site or use alternative identification in the event the procedure is on a mucosal surface or perineum, through a laparoscopic or natural orifice approach, on teeth, or on a premature infant.
"Clinicians should also involve the hospital’s risk management team to assist with managing the event and to determine which regulatory agencies, if any, need to be notified."
Finally, the Universal Protocol calls for conducting a time-out immediately before starting the procedure or initial incision. The World Health Organization developed a surgical safety checklist that is a useful guide to improve surgical safety which includes systematically performing a surgical time-out as well as safety checks immediately before skin incision and prior to the patient leaving the operating room.
The healthcare industry has studied other fields of high-risk activities, such as aviation, and modeled strategies on those of other industries to help decrease the potential for error. The implementation of checklists comes directly from studies in the aviation industry and is based on the premise that the human brain can be affected by certain cognitive limitations. For example, an individual may forget a specific step in a procedure, may remember a specific step but become distracted and unintentionally eliminate the step, or may remember the step and execute that step but not execute it appropriately.
Some techniques used in the aviation industry and translated to healthcare include the following:
- Teamwork training
- Briefings, debriefings, and time-outs
- Incident reporting
- Simulator training
Checklists, which are based on clinical evidence, standardize steps to enhance safety every time. Teamwork training, which is adapted from aviation’s “crew resource management,” uses techniques that focus on improving communication among team members to identify opportunities for mistakes before they happen. The use of briefings, debriefings, and time-outs focuses on ensuring that all team members are on the same page regarding care.
These techniques and the use of time-outs help to foster open communication about what could happen, what went well, and what could have been improved. In addition to implementing strategies to improve safety, encouraging and supporting a culture of safety through non-punitive incident reporting allows hospitals to identify opportunities for improving patient safety by reporting actual events as well as near-misses.
Medicine and technology have advanced to the degree that simulator training is incorporated into the core competencies of physician and nurse education. The use of simulators provides the opportunity for clinicians to gain technical competence as well as practice and encourage effective interdisciplinary communication skills. Identifying opportunities to improve standardization also can decrease errors.
Standardizing communication provides an opportunity to decrease the reliance on cognitive recognition of different scenarios which can decrease a clinician’s attention and provide an opportunity to focus on the task at hand. One clear example of this is the standardization of the physical design of nursing units, patient rooms, and operating suites. The standardization of the physical design prevents the clinician from having to rely on cognitive recall to adjust to different surroundings.
Risk management procedures to help mitigate or avoid the potential for claims related to wrong-site surgery include verification of the implementation of the strategies identified above, which are based on lessons learned from the aviation industry. Pilot Chesley “Sully” Sullenberger, III, the heroic pilot who was responsible for the “Miracle on the Hudson” in 2009, has become an advocate for patient safety.
Sullenberger was the pilot of US Airways flight 1549 that was struck by a flock of geese after takeoff from New York’s LaGuardia airport, causing engine failure in both engines of the plane. Sullenberger and his copilot, with more than 50 years of experience between them, effectively landed the plane in the Hudson River, saving all 155 passengers and crew. Since the accident, he has explained his involvement in patient safety, stating: “It’s applying all the things we’ve learned for decades in aviation and making them transferable to medicine, where the need is so great.”
Estimates indicate that there are between 200,000 and 400,000 medical errors each year that kill patients in US hospitals—which, according to Sullenberger, is equivalent to “three airline passenger planes crashing each day with no survivors.”
Managing an event
Although wrong-site surgery is rare, it does still occur despite strategies in place to avoid it, based on the reality that human factors come into play. Even with checklists, errors can occur, such as skipping steps on the checklist, rushing through the time-out process to accommodate busy surgical schedules, or making other process errors.
There is no evidence to support a specific approach to surgical site verification, but the most comprehensive and universally endorsed protocol is the one put out by The Joint Commission. Even when all efforts are made to prevent the three “Ws” (wrong site, wrong patient, and wrong procedure), it is essential to effectively manage these significant medical errors when they do occur.
First and foremost, clinicians must ensure the safety and wellbeing of the patient. Second, clinicians should demonstrate and articulate with complete transparency the events or error with the patient and family. Clinicians should fully disclose the error, what factors contributed to the error, what measures are being taken to provide the best care to the patient, and what actions are being taken to avoid such an error happening to another patient in the future.
Clinicians should also involve the hospital’s risk management team to assist with managing the event and to determine which regulatory agencies, if any, need to be notified. They should conduct a root cause analysis on the procedures or processes that ultimately had a breakdown contributing to the event. And finally, clinicians should involve hospital finance to determine what (if any) financial implication may occur for the patient, given that CMS and many private payors will not provide reimbursement to the hospital for any additional expenses related to the error.
Hospitals have made significant strides since the national problem of medical error was first reported in Crossing the Quality Chasm: A New Health System for the 21st Century published by the Institute of Medicine in 2001. With greater focus on patient safety and quality of care, often driven by reimbursement models, great progress has been made to scrutinize healthcare delivery models and adjust for and improve patient safety. This continued focus on the processes of providing care, taking into account lessons learned from other high-risk disciplines such as aviation, will continue to improve the quality and safety of care as well as decrease the potential for serious medical errors.
Amanda Budak, RN, CBN, PhD, is vice president of clinical operations for Omnisure Consulting Group.
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