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35. McCrum ML, Allen CM, Han J, Iantorno SE, Presson AP, Wan N.Greater spatial access to care is associated with lower mortality for emergency general surgery. J Trauma Acute Care Surg. 2023;94(2):264–72. https://doi.org/10.1097/ta.0000000000003837.
36. Titan A, Graham L, Rosen A, Itani K, Copeland LA, Mull HJ, et al. Homeless sta­tus, Postdischarge health care utilization, and readmission after Surgery. Med Care. 2018;56(6):460–9. https://doi.org/10.1097/mlr.0000000000000915.
37. Dugravot A, Fayosse A, Dumurgier J, Bouillon K, Rayana TB, Schnitzler A, et al. Social inequalities in multimorbidity, frailty, disability, and transitions to mortality: a 24-year fol­low- up of the Whitehall II cohort study. Lancet Public Health. 2020;5(1):e42–50. https://doi.
org/10.1016/s2468- 2667(19)30226- 9.
38. Haider AH, Scott VK, Rehman KA, Velopulos C, Bentley JM, Cornwell EE 3rd, etal. Racial disparities in surgical care and outcomes in the United States: a comprehensive review of patient, provider, and systemic factors. J Am Coll Surg. 2013;216(3):482–92.e12. https://doi.
org/10.1016/j.jamcollsurg.2012.11.014.
39. Kurani SS, McCoy RG, Lampman MA, Doubeni CA, Finney Rutten LJ, Inselman JW, et al. Association of Neighborhood Measures of social determinants of health with breast, cervical, and colorectal cancer screening rates in the US Midwest. JAMA Netw Open. 2020;3(3):e200618. https://doi.org/10.1001/jamanetworkopen.2020.0618.
40. Crawford S, Schold J.Association between geographic measures of socioeconomic status and deprivation and major surgical outcomes. Med Care. 2019;57(12):949–59. https://doi.
org/10.1097/mlr.0000000000001214.
41. Delman AM, Ammann AM, Turner KM, Vaysburg DM, Van Haren RM. A narrative review of socioeconomic disparities in the treatment of esophageal cancer. J Thorac Dis. 2021;13(6):3801–8.
42. Johnson RL, Roter D, Powe NR, Cooper LA.Patient race/ethnicity and quality of patient­physician communication during medical visits. Am J Public Health. 2004;94(12):2084–90.
https://doi.org/10.2105/ajph.94.12.2084.
43. Birkmeyer JD, Stukel TA, Siewers AE, Goodney PP, Wennberg DE, Lucas FL.Surgeon vol­ume and operative mortality in the United States. N Engl J Med. 2003;349(22):2117–27.
https://doi.org/10.1056/NEJMsa035205.
44. Nathan H, Frederick W, Choti MA, Schulick RD, Pawlik TM.Racial disparity in surgical mor­tality after major hepatectomy. J Am Coll Surg. 2008;207(3):312–9. https://doi.org/10.1016/j.
jamcollsurg.2008.04.015.
45. Nguyen LL, Henry AJ.Disparities in vascular surgery: is it biology or environment? J Vasc Surg. 2010;51(4 Suppl):36s–41s. https://doi.org/10.1016/j.jvs.2010.02.003.
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M. Heide et al.
Chapter 2
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Implementation andUtilization ofChecklists inSurgical Patient Safety
MichaelKochis, NathanTurley, MaryBrindle, andAlexHaynes
Abbreviations
EPIS Explore, Prepare, Implement, Sustain HDI Human Development Index ICU Intensive care unit OR Operating room SSC Surgical Safety Checklist UK United Kingdom US United States VHA Veterans Health Administration WHO World Health Organization
M. Kochis Massachusetts General Hospital, Boston, MA, USA e-mail: mkochis@mgh.harvard.edu
N. Turley EQuIS Research, Department of Surgery, Cumming School of Medicine, The University of Calgary, Calgary, AB, Canada e-mail: nturley@ucalgary.ca
M. Brindle EQuIS Research, Department of Surgery, Cumming School of Medicine, The University of Calgary, Calgary, AB, Canada
Ariadne Labs, Boston, MA, USA e-mail: mbrindle@ariadnelabs.org
A. Haynes ( Department of Surgery and Perioperative Care, Dell Medical School, University of Texas at Austin, Austin, TX, USA e-mail: Alex.Haynes@austin.utexas.edu
Switzerland AG 2024 J. Faintuch, S. Faintuch (eds.), Recent Strategies in High Risk Surgery,
https://doi.org/10.1007/978-3-031-56270-9_2
*)
17© The Author(s), under exclusive license to Springer Nature
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M. Kochis et al.
Introduction
Many people use checklists. Beyond routine applications like planning groceries or chores, checklists designed for teams are simple, low-cost, and effective tools for structuring communication and enhancing collaboration in high-stakes sce­narios. They are used by airplane pilots (pre-ight, post-ight, and others), space agencies launching satellites, large businesses making nancial decisions, and, in the case of many of our readers, surgical teams mitigating errors and complica­tions [1].
Medicine has become increasingly complex, and multidisciplinary teams are common, especially in surgery. Within this environment, checklists help clinicians focus on relevant information at the most appropriate time. By understanding the history of surgical checklists and best practices in their implementation, you can better use them as a member of the perioperative team. It is not simply the existence of a checklist nor its declared use within an organization that effects change, but rather actual integration into routine practice. To achieve lasting change, integration requires resources, time, and cultural buy-in.
What Is aChecklist?
A checklist is a cognitive tool used to aid users’ memories and guide actions. On a group level, it can provide a shared vision about how a process should progress or what situations should prompt discussion or intervention [1]. Depending on the exact circumstance, checklists can be used to help evaluate situations, conrm tasks have been completed, facilitate communication and decision-making, and guide step-by-step actions or considerations in real-time.
Checklists can take many forms, from a tangible instrument such as a paper or a poster, to an electronic application, to even being implied in the deliberate design of a kit of equipment. Weiser and Berry [1] posit there are two types of elements that commonly appear in checklists: “read-do” and “challenge-conrm.” The former can be used as a log of items to consider or tasks to accomplish. A common example is a grocery list, in which an individual crosses off items as they are acquired. On the other hand, “challenge-conrm” checklist elements involve a closed-loop discus­sion between two users. One states an item on the list, and the other issues a response conrming a status or action. For example, before a plane takeoff, one pilot may read, “brake” to which the other replies, “released.” The reality is that many indus­try checklists, including those used in medicine, combine elements of both formats.
As common as checklists may be, there is a growing science underpinning their design. When teams design checklists, they consider the items included on the checklist, the checklists’ performance within the perioperative workow, and, once the checklist is introduced, ways for ensuring its continued success.
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Deliberate Design
Given the range of functions that checklists can achieve, teams must be deliberate in considering a specic checklist’s content as it pertains to the task at hand and local context. For both aspects, attention to human factors is essential. A given checklist should arise from an identied concern and a thorough analysis of what contributes to it. Sometimes, introducing a degree of standardization into a process may be helpful in reducing errors [2].
Teams should be selective that the items they include in their checklist are well- grounded in data, meet local needs, and promote communication [3, 4]. Teams should be conservative in their approach and practice restraint: checklists should be concise and limited in items, as comprehensiveness sacrices usability. After all, any change to a system may introduce new risks, and in healthcare, poorly designed checklists can reduce efciency by distracting clinicians, compli­cating tasks, interrupting work ows, and ultimately hindering the delivery of high quality care [4].
Workow Integration
Equally important to a checklist’s content is its timing. If it is determined that a checklist is a worthwhile intervention, it should be carefully discussed how the checklist will be used and how it may t into existing workows [2]. Typically, checks are performed at natural pauses in a process, to ensure that all relevant materials are acquired, and elements are addressed to allow corrective actions before a non-reversible step forward. Checklists’ progression in an anticipated sequence helps streamline use by ensuring consistency and minimizing disrup­tions, while identifying and correcting errors of omission or commission before consequences to the patient. While some checklists were designed for routine use in all circumstances, others were specically designed for emergencies or uncom­mon situations beyond most people’s familiarity. In the medical context, this ranges from routine pre-procedural time-outs or anesthesia machine set-up to “crisis checklists” which facilitate prompt, coordinated responses to events like venous air embolism, anaphylaxis, cardiac arrest, re, or malignant hyperthermia, among others [5, 6].
Effectiveness
The process of checklist design is just one stage of the more-encompassing process of checklist development [2], which also includes the steps of trial and feedback, formal testing and evaluation, and modication [1].
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M. Kochis et al.
A Role forChecklists inSurgery
Motives: Patient Safety
Surgical checklists originated in the patient safety movement [7]. While the scien­tic and technological advances of the mid-twentieth century fostered an immense growth in the healthcare industry’s ability to treat many medical conditions, so too grew the frequency with which treatments, and particularly surgical interventions, caused inadvertent harm.
In the early 1990s, the “Harvard Medical Practice Study” by Brennan and col­leagues examined outcomes from a year’s worth of hospitalizations in NewYork State. Adverse events occurred in 3.7% of hospitalizations, of which 13.6% led to death [8]; 48% of these errors involved an operation [9]. Nearly a decade later, a similar analysis in Utah and Colorado found the rate of adverse events to be 2.9% of all hospitalizations [10]; among these, 66% were surgical [11]. These ndings were replicated outside the United States (US), with adverse events occurring among 10.8% of hospitalized patients in the United Kingdom (UK) [12] and 7.5% of patients in Canada [13]; again, in both of these countries, surgical care was often the main contributor. In all these analyses, around half of the errors were considered to be preventable [11, 12, 14]. It became clear that action was necessary.
In 2000, the Institute of Medicine issued the landmark publication “To Err is Human.” The publication not only dened the scope of medical errors as common causes of morbidity and mortality, but also examined how systems of care and human factors contribute to them. It served as a call to action to improve the care delivered by creating systems of safety in healthcare organizations [14]. “To Err is Human” spurred a proliferation of research examining the nature of the errors and, ultimately, how to prevent them.
Adverse Events inSurgery
Despite being called “never events” since they can have catastrophic results and are entirely preventable, wrong-site surgery still occurs in about 1in 100,000 cases, and retained surgical items occur in 1in 5000 to 10,000 cases [15]. Additional prevent­able complications common in the surgical context include infection, deep venous thrombosis, and pulmonary embolism [7]. Less dramatically but more commonly, surgical equipment failure, whether related to availability, conguration and set­tings, or direct malfunctioning, was found to occur a median 2.4 times per opera­tion [16].
Given the diversity of negative outcomes, it should come as no surprise that there was great interest in determining their common features and root causes. While many classications have been applied to this purpose, the human performance deciency framework characterizes errors pertaining to planning or problem solv­ing, execution, rules violation, communication, and teamwork. Among individual
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errors in problem solving and execution, cognitive bias and lack of recognition of important pieces of data are each just as frequent as technical errors [17].
Strikingly, 60–70% of sentinel events (serious safety events, registered by accredited hospitals) reported to the Joint Commission on Accreditation of Healthcare Organizations involved a failure of communication [18, 19]. In particu­lar, the patterns of communication breakdowns resulting in injury to surgical patients often clustered around failure in verbal communication between a surgical attending and another caregiver, and ambiguity about responsibilities [18]. Such failures can relate to occasion, content, audience, or purpose: over a third of them affected patient safety by impacting efciency, generating team tension, wasting resources, or resulting in procedural error [19]. The recognition of surgical errors and their relation to cognitive biases and communication failures sparked interest in interventions promoting systematic thinking and better interactions among operat­ing room (OR) teams.
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Antecedents forChecklist Interventions
In an ideal world, tasks would be sequential, predictable, and controllable. However, the real world has interruptions, concurrent tasks, changes in sequence, and unan­ticipated additions. These push us into situations where we try to multitask, which inevitably leads to important things being forgotten [20]. By providing an external reference, checklists compensate for the fallibility of human attention and memory under complex and stressful circumstances [4].
The aviation industry has used checklists for nearly a century, prompted by crashes of Boeing jets own by experienced pilots in the 1930s. It was understood that some systems are simply too complex for even the most accomplished individual to manage alone. The airline industry is a useful parallel to medicine since both elds have unpredictable yet rare deviations, embedded role hierarchy, lengthy training require­ments, and highly visible implications for everyone involved [21]. Another parallel eld is the military, where checklists guide brieng and debrieng sessions to enhance safety by promoting discipline and eliminating errors of omission [22].
Central Line Infections
In 2001, anesthesiologist and critical care physician Dr. Peter Pronovost introduced a bundle of interventions pertaining to central line management at Johns Hopkins Hospital. These interventions included a checklist to reinforce adherence to infection- control practices during line insertion: handwashing, skin cleaning with chlorhexidine, sterile draping of the patient, wearing sterile equipment, and apply­ing a sterile dressing. An initial study indicated the rate of catheter-related blood stream infections decreased dramatically, preventing multiple deaths and saving their hospital millions of dollars per year [23].
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In October 2003, Pronovost’s pilot was followed by a much larger initiative called the “Keystone ICU Project,” which implemented the package at more than 100 intensive care units across Michigan. Over an 18-month study period, this inter­vention decreased the infection rate by 66% [24]. Though Pronovost’s checklist was just one of several aspects to the Keystone ICU Project, his checklist’s impact caught broad attention throughout the surgical space. It inspired surgeon and author Dr. Atul Gawande to muse, “If something so simple can transform intensive care, what else can it do?” [25].
Universal Protocol
Shortly after the Keystone ICU Project, the Joint Commission took decisive action to broadly implement checklists for tackling widespread surgical errors head-on. As such, by July 2004, all accredited organizations had to adhere to a “Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery” [26]. This protocol involved verifying the patient, marking the surgical site, and performing a time-out before the procedure begins. While it is unclear whether the Universal Protocol achieved its goals in reducing the key avoidable surgical errors, it was a profound step toward institutions’ incorporation and habituation of routine safety measures [15].
M. Kochis et al.
Additional Early Surgical Checklists
Also in 2003, while the Keystone ICU Project was happening in the US, a team from Canada developed and implemented a checklist focused on surgical teams and their communication [27]. Using a vascular surgery team as their participants, the researchers found that key communication functions were provision of adequate case-related information, conrmation of details, articulation of concerns, and team building. Practically speaking, the execution of this checklist took just a few min­utes and, while it caused some inconveniences in terms of altered workow, all participants felt the discussions were efcient. Thus, the Canadian study established that a team checklist could promote information exchange and facilitate team cohesion.
The Johns Hopkins OR Brieng checklist was another early tool which had three parts involving introducing members of the team, reviewing information about the procedure, and addressing anticipated hazards in the OR using call-and-response prompts [28].
Three years later, in 2006, the Veterans Health Administration (VHA) imple­mented a nationwide Medical Team Training program across more than 100 facili­ties. Following a 2-month preparation phase, training staff worked with implementation teams to assess problem areas and understand local contexts. The actual training session involved a day-long workshop where OR teams were trained
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to work together, challenge each other when they identied safety risks, and per­form checklist-guided preoperative briengs and postoperative debriengs, among other elements. The initial implementation included quarterly check-ins to enhance transparency and aid in resolving issues. Facilities enrolled in the program wit­nessed notable reductions in mortality and morbidity, with longer implementation periods correlating with even greater decreases [29, 30].
The SURPASS Checklist
Based on the recognition that many, if not most, surgical errors occur outside the OR, the Surgical Patient Safety System (SURPASS) checklist was developed by a group of medical centers in the Netherlands to address the full scope of surgical patients’ care from admission to discharge. Beyond participation from the surgeon, anesthesiologist, and operating assistant, the SURPASS checklist involves partici­pation of the ward doctor and nurse with added components like hand-off of post­operative instructions and medication provision at discharge. While most surgical checklists’ items take place within the OR, SURPASS contains 124 items collected across six time points and multiple potential locations.
The SURPASS checklist was studied from October 2007 to March 2009in the Netherlands. While there was no change in the rate of complications in the control group before and after implementation, intervention hospitals saw a statistically signicant decrease in postoperative complications from 27.3 to 16.7 per 100 patients and a reduction in mortality from 1.5% to 0.8%. Furthermore, when the results were stratied based on checklist compliance, patients for whom 80% or more of checklist items were completed had lower rates of complications than those for whom fewer items were completed [31]. While a benet of the SURPASS checklist is that it is comprehensive and interdisciplinary, it is also complex to implement due to the involvement of multiple teams, time points, and locations, which often requires reorganization of care processes [32].
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The World Health Organization Surgical Safety Checklist (SSC)
Development oftheSSC
By the early 2000s, it was estimated that at least one million patients across the globe died after surgery annually, and seven million were injured from surgical complications [33]. This recognition led the WHO to launch the World Alliance for Patient Safety in October 2004. The Alliance framed their work under “Global Patient Safety Challenges” as a means of focusing and catalyzing global
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commitment to key risk areas. The rst Challenge addressed healthcare-associated infections. The second Global Patient Safety Challenge, which began in January 2007, focused on safe surgery. Here, the WHO Patient Safety Programme convened focus groups of experts from around the globe to settle on four areas of opportunity for dramatic improvement: (1) surgical site infection prevention, (2) safe anesthesia, (3) safe surgical teams, and (4) measurement of surgical services. These discussions ultimately settled on ten safety standards that every surgical team in every setting should meet. Recognizing the simple power of previous checklist interventions in healthcare, the team tasked with the work chose a checklist as the tool to enact change.
Development of the checklist was guided by three principles: simplicity, wide applicability, and measurability. The content was selected based on a comprehen­sive review of safety practices with known benets to surgical patients, with consid­eration of global settings with various resources [21]. In terms of timing, the team identied three points in the typical surgical workow which were conducive to pauses for conrmation and action if needed: “Sign In” prior to induction of anes­thesia: “Time Out” before skin incision, and “Sign Out” before the patient leaves the OR.The SSC was extensively trialed and iterated, whereby confusing actions and language were claried and rened before being retested in new settings according to the Plan-Do-Study-Act model [21]. Through this iterative, consensus-based pro­cess, the initial standards were translated into a highly useable, one-page, 19-item checklist for use in ORs (Fig.2.1) [33]. To successfully develop a surgical checklist, however, formal testing and evaluation are just as important as the initial creation of content, as will be discussed in subsequent sections.
M. Kochis et al.
Global SSC Adoption
The rst stage of this work involved a global pilot. Eight international sites evalu­ated the WHO SSC between October 2007 and September 2008. After baseline data collection, local investigators were given information about site deciencies and tasked with implementing the checklist based on an implementation manual that provided adaptable guidance. The implementation process was intensive and included translation into the local language and tailoring of the checklist and its use to t local practices. This process was followed by written and in-person instruction of surgical teams to optimize buy-in and performance. Patients’ death rate decreased from 1.5% to 0.8% following the SSC’s introduction, and inpatient complication rate decreased from 11.0% to 7.0% [34]. It should be noted that while the sites rep­resented a variety of economic circumstances and diverse patient populations, they were specically chosen to maximize the chances of implementation success and were not necessarily representative of typical hospitals.
Shortly after that pilot study, the SSC proliferated. By March 2009, over 1000 hospitals around the world were using it; by January 2010, that number more than tripled [35]. Numerous health agencies endorsed the checklist and facilitated its
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Fig. 2.1 The World Health Organization/WHO Surgical safety checklist/SSC, initially developed in 2007 and containing 19 items across three perioperative stages. The complete list, reproduced by permission, is available in the chapter of Useful tables and internet sites
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implementation in their jurisdictions. In some instances, the SSC was implemented along with a package of other patient safety interventions [36].
Checklist Outcomes intheReal World
SSC adoption is associated with decreased rates of complications and mortality across diverse global contexts [32, 3739], even those with limited resources [40, 41]. Within the scope of research performed, there are some randomized controlled trials showing positive effects from the checklist, including ones in Norway [42] and India [40], but most studies were pre/post-implementation designs without controls [32].
In January 2009, the United Kingdom’s National Patient Safety Agency man­dated that all National Health System organizations adopt the SSC within a year [43]. While most cases conducted at least one of the checklist’s three panels, the entire checklist was completed only 62% of the time. Patients had a statistically signicant reduced odds of experiencing a complication if all three elements were completed, but not if the checklist was only partially completed. Furthermore, there was a greater benet for high-risk patients than low-risk patients [44].