The US health care system is currently undergoing a paradigm shift from pay-for-service toward pay-for-performance reimbursement, with a focus on quality measures and patient satisfaction. An important tool gaining increasing emphasis during the quality revolution is the surgical checklist. What was once perceived as an invasion of the practitioner’s integrity is now a mainstay in all operating rooms, mandated by several national organizations. Although other fields have pioneered the checklist revolution, neurosurgery is now beginning to follow suit. The authors review the available published neurosurgical checklists and their early results on patient safety.
Key points
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Checklists act as forcing functions, mandating series of evidence-based steps that reduce the potential for error caused by inherent human biases.
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The neurosurgical literature contains 2 different types of checklists: (1) routine checklist to be used in planned interventions and (2) emergent checklist to be used in the unplanned event of a complication.
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Neurosurgical checklists, though in their infancy, are continuing to be developed across all subspecialties.
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Most checklists reported in the neurosurgical literature are single-center studies without external validation.
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After checklist development, successful implementation is a nuanced process, requiring collaboration and commitment from all involved parties.
Introduction
In 1999, the Institute of Medicine published the seminal article “To Err is Human: Building a Safer Health System,” suggesting that anywhere from 44,000 to 98,000 deaths occurred annually in the United States secondary to avoidable medical errors. Earlier reports in the 1980s found that 41% of hospitalized patients were admitted because of iatrogenic disease. Gawande and colleagues postulated that of all hospital admissions nationally in 1992, 3% resulted in adverse events and 50% of these events were preventable. The cost of adverse events is not trivial. One state documented that adverse medical events led to a mortality rate of 13.6% and costs more than $800 million in a single year. The prevention of these avoidable medical errors has contributed to the evolving interest in quality improvement measures, with heavy emphasis on surgical checklists.
In 2008, The World Health Organization (WHO) created the WHO Surgical Safety Checklist. The 19-item checklist sought to address infection prevention and anesthesia-related complications in surgery. In his 2009 book, Checklist Manifesto: How to Get Things Right, Atul Gawande espoused the utility of the checklists in error prevention through systematic corrective measures for generally routine tasks. Gawande’s work popularized the notion of intrinsic human fallibility and the inability to provide excellent outcomes with total reliance on individual performance.
Medicine has seen an explosion in checklists aimed at improving patient safety. Where general surgery and anesthesiology have published extensively on the use of checklists, neurosurgery is now following suit. In a field fraught with life-and-death decisions, where a seemingly minor mishap can lead to unforeseen death, the need for standardizing perioperative activities is paramount. The authors summarize procedural checklists in neurosurgery, from intensive-care-unit (ICU) procedures to specialty-specific operating room (OR) protocols, in hopes of expanding a growing cornerstone of medical and surgical care.
Introduction
In 1999, the Institute of Medicine published the seminal article “To Err is Human: Building a Safer Health System,” suggesting that anywhere from 44,000 to 98,000 deaths occurred annually in the United States secondary to avoidable medical errors. Earlier reports in the 1980s found that 41% of hospitalized patients were admitted because of iatrogenic disease. Gawande and colleagues postulated that of all hospital admissions nationally in 1992, 3% resulted in adverse events and 50% of these events were preventable. The cost of adverse events is not trivial. One state documented that adverse medical events led to a mortality rate of 13.6% and costs more than $800 million in a single year. The prevention of these avoidable medical errors has contributed to the evolving interest in quality improvement measures, with heavy emphasis on surgical checklists.
In 2008, The World Health Organization (WHO) created the WHO Surgical Safety Checklist. The 19-item checklist sought to address infection prevention and anesthesia-related complications in surgery. In his 2009 book, Checklist Manifesto: How to Get Things Right, Atul Gawande espoused the utility of the checklists in error prevention through systematic corrective measures for generally routine tasks. Gawande’s work popularized the notion of intrinsic human fallibility and the inability to provide excellent outcomes with total reliance on individual performance.
Medicine has seen an explosion in checklists aimed at improving patient safety. Where general surgery and anesthesiology have published extensively on the use of checklists, neurosurgery is now following suit. In a field fraught with life-and-death decisions, where a seemingly minor mishap can lead to unforeseen death, the need for standardizing perioperative activities is paramount. The authors summarize procedural checklists in neurosurgery, from intensive-care-unit (ICU) procedures to specialty-specific operating room (OR) protocols, in hopes of expanding a growing cornerstone of medical and surgical care.
Preprocedure time-out
The preprocedural time-out is now a universally performed confirmation of the correct patient and correct operative site and side in virtually every OR in the United States, if not the world. One of the earliest studies of a neurosurgical perioperative checklist was conducted by Lyons whereby one US institution published 8 years of experience with an operative checklist across 6313 operations in 6345 patients. Compliance was extremely high at 99.5%, with no episodes of wrong patient or wrong-site surgery. Oszvald and colleagues conducted a similar advanced perioperative checklist in Germany. The investigators identified 1 wrong-sided emergent burr hole and 1 wrong-sided lumbar approach across 8795 procedures involving 12,390 patients.
Two additional studies modified a general surgical checklist in a neurosurgical population. Da Silva-Freitas and colleagues evaluated the previously mentioned modified WHO surgery safety checklist in 44 neurosurgical operations and identified 51 possible sentinel events in 44 operations. Matsumae and colleagues implemented a similar checklist and used an on-duty safety nurse to ensure all safety practices were being met. Since the widespread adoption of the surgical time-out checklist, specialty- and procedure-specific checklists have gained popularity within neurosurgery (summarized in Table 1 ). The sections that follow discuss such checklists by specialty or procedure.
| Author, Year | Procedure | Main Findings |
|---|---|---|
| Kubilay et al, 2013 | EVD | EVD infection rate decreased from 9.2% to 0% over 4 y after antibiotic-impregnated catheter and procedure checklist implementation. |
| Harrop et al, 2010 | EVD | EVD infection rate decreased from 6.7% to 1.0% and 7.6% to 0.9% in 2 study periods after antibiotic-impregnated catheter and procedure checklist implementation, exclusively in a vascular patient population. |
| Fargen et al, 2012 | Endovascular | It decreased adverse events in 8 out of 9 event types and improved communication after endovascular procedure checklist implementation. |
| Chen, 2011 | Endovascular | There was successful creation of endovascular checklists for aneurysmal rupture and thromboembolic events. |
| Taussky et al, 2010 | Endovascular | There was successful creation of an endovascular checklist in the event of an aneurysmal rupture. |
| Kramer et al, 2012 | Functional | It implemented a 49-step checklist for deep brain stimulation surgery; the use of the checklist decreased the incidence of major errors more than threefold. |
| Rahmathulla et al, 2012 | Tumor | An intraoperative MRI checklist was successfully implemented in 120 craniotomies for tumor resection with no adverse events. |
| Ladak & Spinner, 2014 | Spine | A correct-level spine checklist was successfully created, whereby a second pause occurs when preoperative and intraoperative imaging correlated, such that all members of the surgical team confirm the marked level. |
| Ryan et al, 2014 | Spine | It decreased the spine infection rate from 5.8% to 2.2% after the procedure checklist was implemented. |
| Sugrue et al, 2013 | Spine | There was a multidisciplinary protocol that evaluates safety and risks for patients undergoing high-risk spine surgery. |
| Ziewacz et al, 2012 | Spine | There was an algorithm for the design, development, and implementation for the multidisciplinary response to intraoperative neuromonitoring alerts in spine surgery. |
| Hommelstad et al, 2013 | VP shunt | It decreased the infection rate from 6.5% to 4.3%, with a reduction of 18.4% to 5.7% in children younger than 1 y, after the procedure checklist was implemented. |
| Kestle et al, 2011 | VP shunt | It decreased the infection rate from 8.8% to 5.7% after infection checklist implementation across 4 centers and 21 surgeons. |
External Ventricular Drain
External ventricular drain (EVD) insertion is a common procedure performed in the ICU setting whereby a catheter is inserted into the cerebral ventricular system, thereby allowing drainage of cerebrospinal fluid. EVDs are integral to the ICU management of neurosurgical patients, most common in aneurysmal subarachnoid hemorrhage and intracranial pressure (ICP) management. Several checklists have been developed aimed at preventing infection, as infection may result in increased ICU length of stay and cost as well as patient morbidity and mortality.
Kubilay and colleagues evaluated 2928 ventriculostomies over a 4-year period and documented a reduction in EVD infection rate from 9.2% to 0% after implementation of a best-practice protocol. The protocol was summarized and distributed in succinct checklist form. The checklist included several tasks, including antibiotic administration, hand washing, hair clipping, wide hair clip space for dressing, spectator use of hats and masks, and tunneling the catheter exit site 5 cm from the scalp incision. The investigators successfully implemented a best-practice model in the form of a checklist at a single institution.
A similar study exclusively in cerebrovascular patients showed an equally encouraging decline in EVD infection rates. In more than 1961 ventriculostomies, Harrop and colleagues showed a precipitous decline in infection rate when 2 different antibiotic-impregnated catheters were used, from 6.7% to 1.0% and 7.6% to 0.9% in 2 study time periods. Their procedural protocol included reducing room traffic, electric clippers for hair shaving, full barrier precautions, and a fully gowned surgical scrub for assistance.
Vascular
The treatment of neurovascular patients is complex. The surgical treatments for cerebrovascular disorders continue to evolve and include open surgery or minimally invasive endovascular techniques. Whether for an aneurysm embolization, open clipping, or emergent thrombectomy, checklists have the potential to improve safety in this high-risk patient population.
Endovascular complications range from benign puncture-site hematomas or transient neurologic deficits to aneurysm rupture, arterial dissection, stroke, and thromboembolism. Complications of open clipping occur in approximately 20% of patients, including direct brain injury, cranial nerve injury, postoperative hematoma, and ischemic event. Wong JM, et al reviewed the adverse events of open vascular neurosurgery and concluded a significant proportion of technical adverse events could be reduced by standardized protocols, increased teamwork, and communication.
The current literature contains 2 brands of vascular checklists: routine and emergent. Fargen and colleagues proposed that an endovascular checklist should be completed before any endovascular intervention. Checklist implementation in 60 procedures led to a significant reduction in adverse events as well as improved communication among team members. In emergent situations, Taussky and colleagues postulated a checklist in case of aneurysm perforation during coiling. Similarly, Chen formed 2 checklists in the cases of aneurysmal rupture, with the overall goals of hemostasis and ICP management, and in the cases of thromboembolic events, with overall goals of thrombolysis and distal perfusion optimization. Chen divided the checklist into individual OR personnel roles, rather than team responsibilities, suggesting an alternate manner to delegate responsibility. Despite the utility and need of the emergent checklists, none were reportedly used in a live patient scenario.
Functional
At the opposite end of the neurosurgical spectrum, functional neurosurgery is often elective and associated with lower risk, yet requires precise planning and technique. Deep brain stimulation (DBS), various pain interventions, and epilepsy surgery offers the return of quality of life to patients with medically refractory disorders. The nature of DBS surgery demands absolute precision with respect to electrode placement; a single skipped surgical step could mean incorrect lead placement and subsequent reoperation.
In 2009, Connolly and colleagues described the first checklist specifically designed for DBS and published their results in 28 patients treated for either Parkinson disease or essential tremor. In this relatively small study, 17 patients underwent DBS without the use of a 49-step checklist compared with 11 with checklist implementation. The use of a checklist decreased the incidence of major errors more than threefold from 11 to 3. All 5 cases with no error used the checklist.
Tumor
Similar to vascular intervention, the removal of brain tumors is equally high stakes. Operations can be long, combined with other services, and make use of intraoperative MRI (ioMRI). Wong and colleagues reviewed most common adverse events seen in intracranial neoplasm surgery, which widely ranged from 9% to 40%. DVT was most common, seen in 3%–26%. Second was worsened neurologic deficit, ranging from 0% to 20%, seen most commonly in eloquent glioma surgery. The authors concluded that helpful strategies to reduce adverse events included: image guidance, intraoperative functional mapping, intraoperative MRI, and DVT, infection, and seizure prophylaxis.
Although the authors did not find any checklists specific to the tumor operation itself, Rahmathulla and colleagues described an overview of the ioMRI room, safety considerations, and checklist and protocols used in these cases to maintain safety in their “zero tolerance environment.” Based on their single-institution experience, they used the WHO surgical safety checklist as well as a detailed MRI screening checklist. Before each case, the surgical team engaged in a presurgical briefing huddle, a process that enhanced communication among OR team members. Their checklist yielded 120 ioMRI craniotomies for tumor resection with no preoperative or intraoperative adverse events.
Spine
The United States currently has the highest rate of spine surgery in the world. As the incidence of spine surgery and instrumented fusion increases, so do complication rates. Immediate complications include, durotomy (hole made in the dura), pseudomeningocele, transient neurologic deficit, and permanent neurologic deficit, whereas long-term problems range from pseudoarthrosis or adjacent segment disease to hardware failure.
Wrong-level spinal surgery is an uncommon but unforgivable error. Wrong-level surgery is defined as a surgical procedure performed at the correct site but at the wrong level of the operative field. Without intraoperative radiographs, surgeons initially exposed the wrong level 15% of the time in a prospective study of 100 discectomies. A 2010 study by the same investigators found that wrong-site surgery occurred in an average of 6.8 discectomies, respectively, for every 10,000 procedures performed.
Groff and colleagues surveyed 569 spine surgeons to better understand current practices to avoid wrong-level spine surgery. Surgeons obtained imaging after bony removal 16% of time; 50% of surgeons reported wrong-level lumbar spine surgery at least once; greater than 10% reported wrong-sided lumbar spine surgery at least once. Alarmingly, only 40% of respondents believed the Joint Commission time-out helped reduce these errors. Responses to this article raised interesting questions about wrong-level surgery. For instance, even the most experienced and conscientious surgeons can expose and identify the wrong level in transitional segments and redo operations. Furthermore, respondents argued the considerable difference between wrong-site surgery, such as amputation of the wrong arm, which can be prevented by simply marking and confirming the correct arm preoperatively, and wrong-spinal-level surgery, which can only be prevented through anatomic or radiographic confirmation intraoperatively. The investigators concluded wrong-level spine surgery is clearly more difficult to prevent than other wrong-site surgeries and cannot be treated the same.
In 2001, the North American Spine Society (NASS) developed the Sign, Mark, and X-ray program. This program consists of a checklist seeking to improve patient safety and decrease complications, such as wrong-level surgery, during spine operations. However, evidence suggests that the NASS checklist is insufficient to minimize wrong-level surgery and is now more than a decade old. In 2014, Ladak and Spinner reported a protocol developed by spine surgeons whereby preoperative imaging must be available during the procedure and intraoperative imaging is required. The surgeon must then correlate the preoperative and intraoperative studies and a second pause must be conducted intraoperatively, so that all members of the surgical team confirm the marked level on the image before executing the procedure.
One institution published their experience preventing spine infections in a pediatric population. After implantation of a standardized protocol aimed at infection reduction, the infection rate decreased from 5.8% to 2.2% over 267 cases. Their protocol was succinctly summarized and completed before most operations and included the following steps: sign on OR door, antibiotic administration and redosing, chlorhexidine gluconate and ethyl alcohol solution hand scrub (Avagard, 3M, St Paul, MN) bacitracin irrigation, antibiotic-impregnated sutures, and drain placement.
Similar to aneurysmal rupture, checklists have been designed to deal with neuromonitoring changes intraoperatively. Ziewacz and colleagues published their findings of designing, developing, and implementing a checklist for neuromonitoring alerts in patients with myelopathy. They outlined the roles of the surgeon, neurophysiologist, and anesthesiologist. The article excellently describes a cogent plan of action in the event of acute monitoring changes. Even more important, this study discusses how a checklist is made and successfully implemented.
An excellent review about protocols in high-risk spine surgery completely outlined protocol-based care in spine surgery. The article first described an extensive preoperative spine workup, which included a multidisciplinary conference between hospitalists, anesthesia, and nursing, and multiorgan system clearance. A multifaceted postoperative approach was also outlined, with complete guidelines regarding hemodynamics, coagulation, metabolic, and pulmonary care. Although the article did not address operative checklists, it described a safe, complex, and standardized process for safely operating on high-risk patients with spine disease.
Pediatrics
Checklists have been used routinely in ventriculoperitoneal shunt procedures across pediatric neurosurgery, mainly aimed at reducing infection. A Norwegian study by Hommelstad and colleagues evaluated the effectiveness of a new shunt protocol by comparing 2 time periods across 901 patients, in whom 1404 shunt procedures were performed. The protocol included patient shower, hair removal, OR team wearing surgical hoods, limiting room traffic, patient normothermia, covering instruments until the procedure starts, changing gloves after handling the shunt, and using nontouch techniques whenever possible. Although the investigators saw an overall infection rate decrease from 6.5% to 4.3%, a significant reduction was seen in children younger than 1 year (18.4%–5.7%). Compliance data were missing in 15.6% of cases, and only 192 procedures (24.6%) had 100% compliance. The investigators noted that emergent cases frequently breached protocol. Moreover, the investigators noted that compliance was difficult when multiple surgeons were involved.
A second study conducted by the Hydrocephalus Clinical Research Network (HCRN) evaluated a standardized protocol at 4 institutions aimed at reducing infection, one of the few multi-institution studies. The protocol was developed by reviewing the current literature and prior institutional experience and applied prospectively in the HCRN network. Twenty-one surgeons performed 1571 procedures between 2007 and 2009. The HCRN infection rate decreased significantly from 8.8% before the protocol to 5.7% while using the protocol. The overall protocol compliance was 74.5% and improved over the course of the observation period. The investigators conclude that the protocol was most important in establishing a common baseline with the HCRN. Moreover, the HCRN recorded a 74.5% rate of 100% compliance of all 11 steps and another 20.2% when 10 out of 11 steps were followed. The most common steps missed were antibiotic administration before incision and patient positioning away from the door. The investigators aimed for a shorter, simpler protocol in future iterations, as these have a higher chance of 100% compliance.
Intensive Care Unit
Although not aimed specifically at surgical intervention or bedside procedure, itemized protocols have been used in the ICU setting to improve the care of neurosurgical patients. One institution published their results after tracking 3 interventions in the neurologic ICU setting: mobility, urinary tract infections, and dysphagia screening. All 3 studies championed nursing-administered protocols for ambulation and physical therapy, urinary catheter removal, and bedside swallow tests and were associated with positive improvements in ICU patient care. Outside of neurosurgery, several procedural checklists exist aimed at preventing catheter-related bloodstream infections in procedural checklist form.
Related posts:
Quality Improvement in Neurosurgery
The Relationship Between National Health Care Policies and Quality Improvement in Neurosurgery
Quality Improvement Tools and Processes
Electronic Medical Records and Quality Improvement
Using Clinical Registries to Improve the Quality of Neurosurgical Care
Comanagement Hospitalist Services for Neurosurgery
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