E Special Article
FOCUS: The Society of Cardiovascular Anesthesiologists’ Initiative to Improve Quality and Safety in the Cardiovascular Operating Room Atilio Barbeito, MD, MPH,* William Travis Lau, MD,† Nathaen Weitzel, MD,‡ James H. Abernathy, III, MD, MPH, FASE,§ Joyce Wahr, MD, FAHA,∥ and Jonathan B. Mark, MD* The Society of Cardiovascular Anesthesiologists (SCA) introduced the FOCUS initiative (Flawless Operative Cardiovascular Unified Systems) in 2005 in response to the need for a rigorous scientific approach to improve quality and safety in the cardiovascular operating room (CVOR). The goal of the project, which is supported by the SCA Foundation, is to identify hazards and develop evidence-based protocols to improve cardiac surgery safety. A hazard is anything that has the potential to cause a preventable adverse event. Specifically, the strategic plan of FOCUS includes 3 goals: (1) identifying hazards in the CVOR, (2) prioritizing hazards and developing risk-reduction interventions, and (3) disseminating these interventions. Collectively, the FOCUS initiative, through the work of several groups composed of members from different disciplines such as clinical medicine, human factors engineering, industrial psychology, and organizational sociology, has identified and documented significant hazards occurring daily in our CVORs. Some examples of frequent occurrences that contribute to reduce the safety and quality of care provided to cardiac surgery patients include deficiencies in teamwork, poor OR design, incompatible technologies, and failure to adhere to best practices. Several projects are currently under way that are aimed at better understanding these hazards and developing interventions to mitigate them. The SCA, through the FOCUS initiative, has begun this journey of sciencedriven improvement in quality and safety. There is a long and arduous road ahead, but one we need to continue to travel. (Anesth Analg 2014;119:777–83)
I
n 1994, the Institute of Medicine published America’s Health in Transition: Protecting and Improving Quality1 and launched a much-needed national discussion about the quality of medical care in the United States. The sparks of this initial report soon became searing national headlines after the Institute of Medicine seminal publication, To Err Is Human (1999), which contended that between 44,000 and 98,000 hospitalized people died each year from preventable medical errors,2 and Crossing the Quality Chasm (2001), which highlighted the deficiencies in quality in the American health care system and called for a complete system redesign.3 These reports dramatically changed the conversation about health care delivery in America; attracted great interest from payers, providers, and employers; and reconfigured the way we think about health care quality and safety. At the center of this urgent need to improve health care quality is the issue of patient safety. Lapses in patient safety,
From the *Department of Anesthesiology, Duke University Medical Center, Veterans Affairs Medical Center, Durham, North Carolina; †Department of Anesthesia, The Queen’s Medical Center, Honolulu, Hawaii; ‡Department of Anesthesiology, University of Colorado Denver, Anschutz Medical Campus, Aurora, Colorado; §Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina, Charleston, South C arolina; and ∥Department of Anesthesiology, University of Minnesota, Minneapolis, Minnesota. Accepted for publication May 21, 2014. Funding: None. Conflict of Interest: See Disclosures at the end of the article. Address correspondence and reprint requests to Atilio Barbeito, MD, MPH, Department of Anesthesiology, Duke University Medical Center, VA Medical Center, Durham, 508 Fulton St., Durham, NC 27705. Address e-mail to atilio. [email protected]. Copyright © 2014 International Anesthesia Research Society DOI: 10.1213/ANE.0000000000000359
October 2014 • Volume 119 • Number 4
mistakes in the provision of health care that expose patients to “additive” risk for complications or injuries that did not exist before the clinical encounter, still occur at alarming rates in our health care delivery system.4 Although focusing on patient safety may ignore even broader threats to the health of our population, such as inadequate access or other aspects of quality, assuring patient safety is a foundational principle for providing quality care. Nothing is more contrary to the ethos of medicine than harming a patient when that harm is avoidable. The Society of Cardiovascular Anesthesiologists (SCA) recognized the need for a rigorous scientific approach to quality and safety almost a decade ago and introduced the FOCUS initiative (Flawless Operative Cardiovascular Unified Systems) in 2005. The terms flawless and unified systems included in the program acronym were inspired by senior aviation safety consultant John Nance, who asserted that “individuals can and will commit errors, but teams have the ability to be flawless.”5 The goal of the FOCUS project, which is supported by the SCA Foundation (SCAF), is to identify hazards and develop evidence-based protocols to improve cardiac surgery safety.6 This commentary will describe the major results of the FOCUS projects to date, offer common themes or lessons learned through these efforts, and identify future research challenges and opportunities for improving the safety of cardiovascular care.
THE FOCUS INITIATIVE: PROJECTS
The FOCUS initiative was the SCA’s response to the urgent need to improve safety in medicine in general and in the cardiovascular operating room (CVOR) in particular. In 2005, the SCA Board of Directors appointed a steering www.anesthesia-analgesia.org
777
E special article committeea to consider a national research agenda that would improve patient safety by decreasing the incidence and severity of human error in the CVOR through scientific analysis leading to culture change. The SCA set up a foundation to raise funds to support this research and provided more than $1 million to initiate the work. A request for proposals was then submitted in the spring of 2006 and a contract awarded to the Johns Hopkins Quality and Safety Research Group (now the Armstrong Institute of Patient Safety and Quality), a multidisciplinary group with extensive experience and success in perioperative and critical care patient safety research. Their Locating Errors through Networked Surveillance (LENS) project constituted the core of the FOCUS work for its first 5 years. Although the initial request for proposals was focused on anesthesia safety in the CVOR, it quickly became apparent that any CVOR safety initiative would have to be multidisciplinary to be effective. Representation on the FOCUS steering committee was offered to the Association of Operating Room Nurses and the American Society of Extracorporeal Technology, both of which formally endorsed FOCUS and appointed representatives. While the FOCUS steering committee has not had a formal representative from a national cardiac surgery association, there has been continuous participation by several cardiovascular surgeons through regular meetings.
The LENS Project
The acronym for this project was chosen carefully: the approach was to integrate the wisdom of diverse disciplines including industrial psychology, organizational sociology, human factors engineering, and cardiovascular clinical care to achieve harm-free surgery. As stated in the LENS project proposal, each discipline would have the ability to “see” the hazards through its own “lens,” therefore providing a more comprehensive view of the problem.7 The project was structured in 3 phases: (1) identifying hazards in the CVOR, (2) prioritizing hazards and developing risk-reduction interventions, and (3) disseminating these interventions. In other words, the goals were to understand what is wrong with the current system, design solutions, and disseminate them broadly. These 3 phases eventually guided the overall strategic plan for the FOCUS initiative, and at the present time, these form the framework for the many studies performed under the umbrellas of FOCUS, the SCA, and the SCAF (Fig. 1). The group first conducted a focused qualitative literature review of hazards during cardiac surgery.8 In the patient safety literature, a hazard is anything that has the potential to cause a preventable adverse event.9 Using the more familiar Swiss cheese model terms, the holes in the slices of cheese each represent a hazard; when several of these hazards align, a patient is injured. This literature review identified 55 studies on cardiac surgery–specific hazards occurring during the intraoperative period. The vast majority of them were retrospective, and most were case reports, which speaks to the predominantly reactive stance in this body of research. In addition, the perspectives (clinical, a Members of the SCA Steering Committee at the time included Bruce Spiess, Paul Barash, David Cook, Solomon Aronson, James Ramsay, Nancy Nussmeier, and Linda Shore-Lesserson.
778 www.anesthesia-analgesia.org
Figure 1. FOCUS strategic goals and their corresponding projects. FOCUS = Flawless Operative Cardiovascular Unified Systems.
human factors, psychology, sociology) and taxonomies used to classify hazards varied widely throughout these reports, making it challenging to study them. Overall, the LENS investigators found a multitude of hazards occurring daily in the CVOR such as poor teamwork, violations in safety standards, and staffs that are uncomfortable speaking up. The authors used the Systems Engineering Initiative for Patient Safety (SEIPS) taxonomy10 to classify these numerous and seemingly disparate hazards. This is a useful framework for future studies on hazards in perioperative care. This same group then analyzed all cardiac surgery events reported in the United Kingdom National Reporting and Learning System (NRLS), one of the largest national health care incident reporting systems in the world.11 This is a voluntary web-based system that is managed by the National Health Service. Among the nearly 1 million incidents entered between 2003 and 2007, 4828 were recorded as related to cardiac surgery. Twenty-one percent of these occurred in the OR. Given that the time spent in the OR is a very small fraction (on average 4%) of a patient’s time in the hospital, presence in the OR is an especially vulnerable period during a patient’s hospital stay. Furthermore, onethird of these incidents resulted in patient harm, when compared with 1 in 4 for non-OR incidents. The most common incidents reported were treatment/procedure and device/ equipment related. Last, communication and distractions contributed to all types of incidents. Using the themes identified in these 2 analyses, the LENS investigators designed a prospective study to identify hazards in the CVOR through direct observation. This occurred between February and September 2008 at 5 clinical sites, including 2 academic institutions, 2 teaching community hospitals, and 1 nonteaching community hospital. The goal was to obtain a sample that would be representative of a variety of practices and patient populations. A multidisciplinary team conducted on-site observations during the duration of surgical procedures and extensive surveys of patient safety culture that included the entire CVOR team. The observations identified hazards to patient safety such as practice variations among care providers, poor teamwork and hierarchical cultures in the OR, violations of guidelines and protocols, and cramped and cluttered workspaces. All these hazards were coded and organized using the SEIPS model, the same event taxonomy used in the retrospective literature review reported above. Among the many positive attributes of this model, SEIPS allows for the study of interactions among the different components of the system. For example, the LENS investigators focused
anesthesia & analgesia
Quality and Safety in Cardiac Surgery: The FOCUS Initiative
on technology-related hazards (anything related to technology that has the potential to cause a medical error). In a separate publication, they identified the different sources of these hazards (design flaws, organizational characteristics, physical environmental factors) and their impact on provider cognition.12 For example, they describe how a poorly designed IV infusion pump can affect the attention of the provider, introducing a hazard. While traditional studies focus on 1 technology at a time and the hazards associated with that specific technology, the SEIPS model allows the study of multiple technologies working together during a case. In other words, the model allows for an improved understanding of the complexity present in the CVOR and a more refined study of the associated hazards. The work performed by the LENS investigators is important for several reasons. First, these were prospective observations by external reviewers, which have been shown to identify up to 5 times more hazards than selfassessments.13,14 Second, the multiple disciplines involved (cardiovascular clinical care, human factors engineering, psychology, sociology) provide a more detailed, diverse, and objective list of hazards and errors. Last, the LENS investigators introduced SEIPS as a tool that can be used by other research and quality improvement teams to study and redesign care during cardiac and thoracic surgery. While the LENS investigators outlined a host of hazards that occur daily in CVORs and identified numerous opportunities to improve safety,15 performing this type of observational research, identifying hazards through direct observations, was difficult. For example, although the LENS project was intended to be an observational quality improvement project, IRBs at the 5 participating sites interpreted the LENS study in a variety of ways. Consistent, national guidelines for this type of safety and quality improvement work, including IRB responsibilities, will make projects like these easier to perform in the future.16 The initial report of the observational methods used and the process of analysis15 garnered a good deal of interest and was accompanied by an editorial that lauded the LENS model as “the next phase in [the] evolution of understanding through direct observation and analysis of work processes.”17
The RIPCHORD Study Group
Another group that is part of the FOCUS Initiative and that has been active in the study of hazards in the CVOR is the RIPCHORD (Realizing Improved Patient Care through Human Centered OR Design) Study Group. This team of industrial engineers and health care architects with expertise in human factors from Clemson University and cardiothoracic anesthesiologists from the Medical University of South Carolina investigated flow disruptions in the CVOR. Human factors engineers have determined that disruptions in flow precede the majority of OR errors. Seemingly trivial events such as tripping over a wire, being interrupted by a phone call in the middle of a procedure, or having to search for missing items all introduce unwanted distractions that allow errors to occur. In fact, the number of flow disruptions is directly related to the number of surgical errors.18 Additionally, minor events (failures that, in isolation, are not expected to have serious consequences) have been
October 2014 • Volume 119 • Number 4
shown to be predictive of major morbidity and mortality during cardiac surgery.19 The RIPCHORD group observed 10 cardiac surgical procedures over a 2-week period and detected 1080 flow disruptions or >100 disruptions per case. The largest number of flow disruptions occurred because of OR layout, and the second most common category was described as general interruptions. The investigators also plotted the movements of OR personnel over time and described how each provider group (e.g., nurses, anesthesiologists, perfusionists, surgeons) was impacted by the physical layout of the OR, thereby allowing the investigators to identify specific zones in the OR where flow disruptions occurred most frequently.
Other Ongoing Studies
The second strategic goal of the FOCUS initiative is to prioritize hazards and develop risk-reduction interventions. FOCUS investigators held 2 full-day priority-setting conferences where the data collected in the LENS projects, including the literature review, the analysis of the NRLS, and the observational data, were comprehensively reviewed. Numerous lapses in infection prevention best practices had been uncovered in the observational data set, as well as in the NRLS analysis, and therefore this topic was considered very amenable to intervention.20 The FOCUS investigators formed a learning collaborative led by the Johns Hopkins Armstrong Institute of Patient Safety and Quality, and subsequently, the Agency for Healthcare Research and Quality awarded a 4-year research grant of $4 million to the FOCUS initiative to eliminate health care–associated infections in cardiac operations through improved teamwork and evidence-based interventions. The project, entitled Cardiac Surgery Translational Study, involves 17 FOCUS sites and is now in its fourth year. Investigators from the RIPCHORD Study Group, together with experts in human factors and human factors doctoral students from Embry-Riddle Aeronautical University, are currently working on a project entitled Creating Operating Room Efficiency to Optimize Patient Safety. The group has reanalyzed the data from the LENS project using different human factors frameworks to better understand and prioritize hazards and is currently performing observations of cardiac surgical procedures at 3 different centers across the United States with the goal of capturing hazards and flow disruptions with an even greater level of resolution. Last, the FOCUS initiative’s third strategic goal consists of disseminating interventions to mitigate the hazards identified. As a first step toward this goal, FOCUS investigators are developing a peer-to-peer assessment program similar to the nuclear power industry’s current peer-review process.b In their peer-to-peer program, members of the organization (in this case the World Association of Nuclear Operators) visit other plants and evaluate their processes, learning and sharing best practices, and making recommendations in a nonregulatory, nonjudgmental manner, with the sole goal of learning and improving safety. FOCUS investigators from the Medical University of South Carolina, the Henry Ford Medical School, Washington World Association of Nuclear Operators (WANO), Peer Reviews. Available at: http://www.wano.info/programmes/peer-reviews. Accessed April 21, 2014.
b
www.anesthesia-analgesia.org
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E special article University, and the University of Minnesota have obtained an educational grant to develop, validate, and deploy an evidence-based tool for OR personnel to use in assessing medication safety profiles across institutions. This constitutes the first step toward a peer-to-peer assessment process across cardiothoracic surgery centers. A timeline with the main FOCUS projects can be found in Figure 2. Information about these projects and other FOCUS activities can be found at the SCAF webpage (http://scahqgive. org/flawless-operative-cardiovascular-unified-systems). In addition to the projects described above, FOCUS investigators worked with other professionals to coauthor a Scientific Statement on Patient Safety in the Cardiac Operating Room, recently published by the American Heart Association.21 This work, performed in collaboration with experts from many disciplines, resulted from years of work in perioperative safety and quality. It was driven in large part by the FOCUS initiative and exemplifies the leading role that anesthesiologists can take in this vitally important clinical area.
THE FOCUS INITIATIVE: LESSONS LEARNED
The knowledge gained from the various FOCUS projects has been summarized in 10 peer-reviewed manuscripts published over the past 4 years.5–8,11,12,15,16,22,23 A summary of these publications and their most relevant findings is provided in Table 1. Here, we highlight the overarching themes that have emerged through the FOCUS initiative and the process of studying hazards in the CVOR. Quality improvement work in the CVOR is often slow and difficult: This is perhaps not surprising because improving quality and safety in health care in general has been difficult and progress has been slow. Many reasons have been cited for this, but they could all be summarized by the fact that we have not invested enough time, money, and effort in the “science of improvement.”24,25 A multidisciplinary approach is needed: The solutions to safety problems are generally complex and require a multidisciplinary approach.8 Every project described above includes researchers from disciplines such as industrial
engineering, human factors engineering, health care architecture, and industrial psychology. While other industries have a long history of identifying safety hazards and designing solutions with multidisciplinary input, this approach is relatively new in perioperative medicine, but one that is essential if long-lasting, meaningful solutions are to be designed and implemented. We are less familiar with the methodology required for this type of work: Structured observational research is a term used to describe the activities of an individual or a team of researchers who “live” alongside a given workforce, observing and systematically recording how they behave.26 It has been used in several settings to understand individual, team, and organizational precursors of adverse events. The data collected are mostly qualitative, but quantitative (statistical) analysis is also performed. This form of research, which may be considered a form of adapted and extended ethnography (a discipline originally developed by social scientists), is less familiar to the broader health care and research communities. We lack taxonomies: The data we collect through this type of research are often difficult to categorize. This is important when prioritizing and designing interventions. In this regard, the FOCUS projects outlined here have provided valuable contributions to this field by presenting a clear framework for organizing hazards and flow disruptions.8,15,23 These taxonomies will aid in the development of data-driven interventions based on established human factors principles. We do not have enough data: Without data, inferences about what constitutes unsafe care are only assumptions or “armchair guessing.” Drawing an analogy from clinical medicine, this would be the equivalent of writing a prescription without making a diagnosis. Additionally, many proposed interventions to improve safety are never tested for efficacy but are simply mandated by local or national entities, only to find out years later that they are ineffective. The data obtained through the various FOCUS projects will allow us to quantify hazards and design and prioritize interventions to mitigate them.
Figure 2. FOCUS initiative timeline with its 5 major projects. Each shade of blue corresponds to a different strategic goal. FOCUS = Flawless Operative Cardiovascular Unified Systems.
780 www.anesthesia-analgesia.org
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Quality and Safety in Cardiac Surgery: The FOCUS Initiative
Table 1. FOCUS-Related Publications and Key Findings Year Publication title 2010 Bring your life into FOCUS!6
Publication type Journal Editorial Anesthesia & Analgesia Commentary Anesthesia & Analgesia
2010 The Society of Cardiovascular Anesthesiologists’ FOCUS initiative: locating errors through networked surveillance (LENS) project vision7 2011 Human error in medicine: change Commentary in cardiac operating rooms through the FOCUS initiative5 2011 High stakes and high risk: a Review Article focused qualitative review of hazards during cardiac surgery8
2011 Cardiac surgery errors: results from the United Kingdom National Reporting and Learning System11 2012 Identifying and categorizing patient safety hazards in cardiovascular operating rooms using an interdisciplinary approach: a multisite study15 2012 Variation in local institutional review board evaluations of a multicenter patient safety study16
2012 Using human factors engineering to improve patient safety in the cardiovascular operating room22 2013 Technologies in the wild (TiW): human factors implications for patient safety in the cardiovascular operating room12 2013 Realizing improved patient care through human-centered operating room design23
2013 Patient safety in the cardiac operating room: human factors and teamwork; a scientific statement from the American Heart Association21
2014 Locating errors through networked surveillance: a multimethod approach to peer assessment, hazard identification, and prioritization of patient safety efforts in cardiac surgery20
Key findings • Briefly summarizes the problem of human error in medicine and introduces the FOCUS initiative as the SCA’s effort to improve cardiac surgery safety • Describes the LENS Project vision and overall strategy
• Provides preliminary results of prospective observations of hazards The Journal of in the cardiac OR performed by the LENS investigators Extracorporeal Circulation Anesthesia & • A qualitative literature review that identifies 55 articles on cardiac OR Analgesia hazards and classifies them using the SEIPS taxonomy • Discusses the varied methods of data collection, taxonomies for organizing these data, and different approaches for analysis • Key findings include poor teamwork, violations of safety standards, and deficiencies in safety climate • Only one report identifies medication errors; there are no reports of hazards introduced by tools and technology • This voluntary incident reporting system includes 983,660 incidents, of International Retrospective which 4828 (
FOCUS: The Society of Cardiovascular Anesthesiologists’ Initiative to Improve Quality and Safety in the Cardiovascular Operating Room Atilio Barbeito, MD, MPH,* William Travis Lau, MD,† Nathaen Weitzel, MD,‡ James H. Abernathy, III, MD, MPH, FASE,§ Joyce Wahr, MD, FAHA,∥ and Jonathan B. Mark, MD* The Society of Cardiovascular Anesthesiologists (SCA) introduced the FOCUS initiative (Flawless Operative Cardiovascular Unified Systems) in 2005 in response to the need for a rigorous scientific approach to improve quality and safety in the cardiovascular operating room (CVOR). The goal of the project, which is supported by the SCA Foundation, is to identify hazards and develop evidence-based protocols to improve cardiac surgery safety. A hazard is anything that has the potential to cause a preventable adverse event. Specifically, the strategic plan of FOCUS includes 3 goals: (1) identifying hazards in the CVOR, (2) prioritizing hazards and developing risk-reduction interventions, and (3) disseminating these interventions. Collectively, the FOCUS initiative, through the work of several groups composed of members from different disciplines such as clinical medicine, human factors engineering, industrial psychology, and organizational sociology, has identified and documented significant hazards occurring daily in our CVORs. Some examples of frequent occurrences that contribute to reduce the safety and quality of care provided to cardiac surgery patients include deficiencies in teamwork, poor OR design, incompatible technologies, and failure to adhere to best practices. Several projects are currently under way that are aimed at better understanding these hazards and developing interventions to mitigate them. The SCA, through the FOCUS initiative, has begun this journey of sciencedriven improvement in quality and safety. There is a long and arduous road ahead, but one we need to continue to travel. (Anesth Analg 2014;119:777–83)
I
n 1994, the Institute of Medicine published America’s Health in Transition: Protecting and Improving Quality1 and launched a much-needed national discussion about the quality of medical care in the United States. The sparks of this initial report soon became searing national headlines after the Institute of Medicine seminal publication, To Err Is Human (1999), which contended that between 44,000 and 98,000 hospitalized people died each year from preventable medical errors,2 and Crossing the Quality Chasm (2001), which highlighted the deficiencies in quality in the American health care system and called for a complete system redesign.3 These reports dramatically changed the conversation about health care delivery in America; attracted great interest from payers, providers, and employers; and reconfigured the way we think about health care quality and safety. At the center of this urgent need to improve health care quality is the issue of patient safety. Lapses in patient safety,
From the *Department of Anesthesiology, Duke University Medical Center, Veterans Affairs Medical Center, Durham, North Carolina; †Department of Anesthesia, The Queen’s Medical Center, Honolulu, Hawaii; ‡Department of Anesthesiology, University of Colorado Denver, Anschutz Medical Campus, Aurora, Colorado; §Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina, Charleston, South C arolina; and ∥Department of Anesthesiology, University of Minnesota, Minneapolis, Minnesota. Accepted for publication May 21, 2014. Funding: None. Conflict of Interest: See Disclosures at the end of the article. Address correspondence and reprint requests to Atilio Barbeito, MD, MPH, Department of Anesthesiology, Duke University Medical Center, VA Medical Center, Durham, 508 Fulton St., Durham, NC 27705. Address e-mail to atilio. [email protected]. Copyright © 2014 International Anesthesia Research Society DOI: 10.1213/ANE.0000000000000359
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mistakes in the provision of health care that expose patients to “additive” risk for complications or injuries that did not exist before the clinical encounter, still occur at alarming rates in our health care delivery system.4 Although focusing on patient safety may ignore even broader threats to the health of our population, such as inadequate access or other aspects of quality, assuring patient safety is a foundational principle for providing quality care. Nothing is more contrary to the ethos of medicine than harming a patient when that harm is avoidable. The Society of Cardiovascular Anesthesiologists (SCA) recognized the need for a rigorous scientific approach to quality and safety almost a decade ago and introduced the FOCUS initiative (Flawless Operative Cardiovascular Unified Systems) in 2005. The terms flawless and unified systems included in the program acronym were inspired by senior aviation safety consultant John Nance, who asserted that “individuals can and will commit errors, but teams have the ability to be flawless.”5 The goal of the FOCUS project, which is supported by the SCA Foundation (SCAF), is to identify hazards and develop evidence-based protocols to improve cardiac surgery safety.6 This commentary will describe the major results of the FOCUS projects to date, offer common themes or lessons learned through these efforts, and identify future research challenges and opportunities for improving the safety of cardiovascular care.
THE FOCUS INITIATIVE: PROJECTS
The FOCUS initiative was the SCA’s response to the urgent need to improve safety in medicine in general and in the cardiovascular operating room (CVOR) in particular. In 2005, the SCA Board of Directors appointed a steering www.anesthesia-analgesia.org
777
E special article committeea to consider a national research agenda that would improve patient safety by decreasing the incidence and severity of human error in the CVOR through scientific analysis leading to culture change. The SCA set up a foundation to raise funds to support this research and provided more than $1 million to initiate the work. A request for proposals was then submitted in the spring of 2006 and a contract awarded to the Johns Hopkins Quality and Safety Research Group (now the Armstrong Institute of Patient Safety and Quality), a multidisciplinary group with extensive experience and success in perioperative and critical care patient safety research. Their Locating Errors through Networked Surveillance (LENS) project constituted the core of the FOCUS work for its first 5 years. Although the initial request for proposals was focused on anesthesia safety in the CVOR, it quickly became apparent that any CVOR safety initiative would have to be multidisciplinary to be effective. Representation on the FOCUS steering committee was offered to the Association of Operating Room Nurses and the American Society of Extracorporeal Technology, both of which formally endorsed FOCUS and appointed representatives. While the FOCUS steering committee has not had a formal representative from a national cardiac surgery association, there has been continuous participation by several cardiovascular surgeons through regular meetings.
The LENS Project
The acronym for this project was chosen carefully: the approach was to integrate the wisdom of diverse disciplines including industrial psychology, organizational sociology, human factors engineering, and cardiovascular clinical care to achieve harm-free surgery. As stated in the LENS project proposal, each discipline would have the ability to “see” the hazards through its own “lens,” therefore providing a more comprehensive view of the problem.7 The project was structured in 3 phases: (1) identifying hazards in the CVOR, (2) prioritizing hazards and developing risk-reduction interventions, and (3) disseminating these interventions. In other words, the goals were to understand what is wrong with the current system, design solutions, and disseminate them broadly. These 3 phases eventually guided the overall strategic plan for the FOCUS initiative, and at the present time, these form the framework for the many studies performed under the umbrellas of FOCUS, the SCA, and the SCAF (Fig. 1). The group first conducted a focused qualitative literature review of hazards during cardiac surgery.8 In the patient safety literature, a hazard is anything that has the potential to cause a preventable adverse event.9 Using the more familiar Swiss cheese model terms, the holes in the slices of cheese each represent a hazard; when several of these hazards align, a patient is injured. This literature review identified 55 studies on cardiac surgery–specific hazards occurring during the intraoperative period. The vast majority of them were retrospective, and most were case reports, which speaks to the predominantly reactive stance in this body of research. In addition, the perspectives (clinical, a Members of the SCA Steering Committee at the time included Bruce Spiess, Paul Barash, David Cook, Solomon Aronson, James Ramsay, Nancy Nussmeier, and Linda Shore-Lesserson.
778 www.anesthesia-analgesia.org
Figure 1. FOCUS strategic goals and their corresponding projects. FOCUS = Flawless Operative Cardiovascular Unified Systems.
human factors, psychology, sociology) and taxonomies used to classify hazards varied widely throughout these reports, making it challenging to study them. Overall, the LENS investigators found a multitude of hazards occurring daily in the CVOR such as poor teamwork, violations in safety standards, and staffs that are uncomfortable speaking up. The authors used the Systems Engineering Initiative for Patient Safety (SEIPS) taxonomy10 to classify these numerous and seemingly disparate hazards. This is a useful framework for future studies on hazards in perioperative care. This same group then analyzed all cardiac surgery events reported in the United Kingdom National Reporting and Learning System (NRLS), one of the largest national health care incident reporting systems in the world.11 This is a voluntary web-based system that is managed by the National Health Service. Among the nearly 1 million incidents entered between 2003 and 2007, 4828 were recorded as related to cardiac surgery. Twenty-one percent of these occurred in the OR. Given that the time spent in the OR is a very small fraction (on average 4%) of a patient’s time in the hospital, presence in the OR is an especially vulnerable period during a patient’s hospital stay. Furthermore, onethird of these incidents resulted in patient harm, when compared with 1 in 4 for non-OR incidents. The most common incidents reported were treatment/procedure and device/ equipment related. Last, communication and distractions contributed to all types of incidents. Using the themes identified in these 2 analyses, the LENS investigators designed a prospective study to identify hazards in the CVOR through direct observation. This occurred between February and September 2008 at 5 clinical sites, including 2 academic institutions, 2 teaching community hospitals, and 1 nonteaching community hospital. The goal was to obtain a sample that would be representative of a variety of practices and patient populations. A multidisciplinary team conducted on-site observations during the duration of surgical procedures and extensive surveys of patient safety culture that included the entire CVOR team. The observations identified hazards to patient safety such as practice variations among care providers, poor teamwork and hierarchical cultures in the OR, violations of guidelines and protocols, and cramped and cluttered workspaces. All these hazards were coded and organized using the SEIPS model, the same event taxonomy used in the retrospective literature review reported above. Among the many positive attributes of this model, SEIPS allows for the study of interactions among the different components of the system. For example, the LENS investigators focused
anesthesia & analgesia
Quality and Safety in Cardiac Surgery: The FOCUS Initiative
on technology-related hazards (anything related to technology that has the potential to cause a medical error). In a separate publication, they identified the different sources of these hazards (design flaws, organizational characteristics, physical environmental factors) and their impact on provider cognition.12 For example, they describe how a poorly designed IV infusion pump can affect the attention of the provider, introducing a hazard. While traditional studies focus on 1 technology at a time and the hazards associated with that specific technology, the SEIPS model allows the study of multiple technologies working together during a case. In other words, the model allows for an improved understanding of the complexity present in the CVOR and a more refined study of the associated hazards. The work performed by the LENS investigators is important for several reasons. First, these were prospective observations by external reviewers, which have been shown to identify up to 5 times more hazards than selfassessments.13,14 Second, the multiple disciplines involved (cardiovascular clinical care, human factors engineering, psychology, sociology) provide a more detailed, diverse, and objective list of hazards and errors. Last, the LENS investigators introduced SEIPS as a tool that can be used by other research and quality improvement teams to study and redesign care during cardiac and thoracic surgery. While the LENS investigators outlined a host of hazards that occur daily in CVORs and identified numerous opportunities to improve safety,15 performing this type of observational research, identifying hazards through direct observations, was difficult. For example, although the LENS project was intended to be an observational quality improvement project, IRBs at the 5 participating sites interpreted the LENS study in a variety of ways. Consistent, national guidelines for this type of safety and quality improvement work, including IRB responsibilities, will make projects like these easier to perform in the future.16 The initial report of the observational methods used and the process of analysis15 garnered a good deal of interest and was accompanied by an editorial that lauded the LENS model as “the next phase in [the] evolution of understanding through direct observation and analysis of work processes.”17
The RIPCHORD Study Group
Another group that is part of the FOCUS Initiative and that has been active in the study of hazards in the CVOR is the RIPCHORD (Realizing Improved Patient Care through Human Centered OR Design) Study Group. This team of industrial engineers and health care architects with expertise in human factors from Clemson University and cardiothoracic anesthesiologists from the Medical University of South Carolina investigated flow disruptions in the CVOR. Human factors engineers have determined that disruptions in flow precede the majority of OR errors. Seemingly trivial events such as tripping over a wire, being interrupted by a phone call in the middle of a procedure, or having to search for missing items all introduce unwanted distractions that allow errors to occur. In fact, the number of flow disruptions is directly related to the number of surgical errors.18 Additionally, minor events (failures that, in isolation, are not expected to have serious consequences) have been
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shown to be predictive of major morbidity and mortality during cardiac surgery.19 The RIPCHORD group observed 10 cardiac surgical procedures over a 2-week period and detected 1080 flow disruptions or >100 disruptions per case. The largest number of flow disruptions occurred because of OR layout, and the second most common category was described as general interruptions. The investigators also plotted the movements of OR personnel over time and described how each provider group (e.g., nurses, anesthesiologists, perfusionists, surgeons) was impacted by the physical layout of the OR, thereby allowing the investigators to identify specific zones in the OR where flow disruptions occurred most frequently.
Other Ongoing Studies
The second strategic goal of the FOCUS initiative is to prioritize hazards and develop risk-reduction interventions. FOCUS investigators held 2 full-day priority-setting conferences where the data collected in the LENS projects, including the literature review, the analysis of the NRLS, and the observational data, were comprehensively reviewed. Numerous lapses in infection prevention best practices had been uncovered in the observational data set, as well as in the NRLS analysis, and therefore this topic was considered very amenable to intervention.20 The FOCUS investigators formed a learning collaborative led by the Johns Hopkins Armstrong Institute of Patient Safety and Quality, and subsequently, the Agency for Healthcare Research and Quality awarded a 4-year research grant of $4 million to the FOCUS initiative to eliminate health care–associated infections in cardiac operations through improved teamwork and evidence-based interventions. The project, entitled Cardiac Surgery Translational Study, involves 17 FOCUS sites and is now in its fourth year. Investigators from the RIPCHORD Study Group, together with experts in human factors and human factors doctoral students from Embry-Riddle Aeronautical University, are currently working on a project entitled Creating Operating Room Efficiency to Optimize Patient Safety. The group has reanalyzed the data from the LENS project using different human factors frameworks to better understand and prioritize hazards and is currently performing observations of cardiac surgical procedures at 3 different centers across the United States with the goal of capturing hazards and flow disruptions with an even greater level of resolution. Last, the FOCUS initiative’s third strategic goal consists of disseminating interventions to mitigate the hazards identified. As a first step toward this goal, FOCUS investigators are developing a peer-to-peer assessment program similar to the nuclear power industry’s current peer-review process.b In their peer-to-peer program, members of the organization (in this case the World Association of Nuclear Operators) visit other plants and evaluate their processes, learning and sharing best practices, and making recommendations in a nonregulatory, nonjudgmental manner, with the sole goal of learning and improving safety. FOCUS investigators from the Medical University of South Carolina, the Henry Ford Medical School, Washington World Association of Nuclear Operators (WANO), Peer Reviews. Available at: http://www.wano.info/programmes/peer-reviews. Accessed April 21, 2014.
b
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E special article University, and the University of Minnesota have obtained an educational grant to develop, validate, and deploy an evidence-based tool for OR personnel to use in assessing medication safety profiles across institutions. This constitutes the first step toward a peer-to-peer assessment process across cardiothoracic surgery centers. A timeline with the main FOCUS projects can be found in Figure 2. Information about these projects and other FOCUS activities can be found at the SCAF webpage (http://scahqgive. org/flawless-operative-cardiovascular-unified-systems). In addition to the projects described above, FOCUS investigators worked with other professionals to coauthor a Scientific Statement on Patient Safety in the Cardiac Operating Room, recently published by the American Heart Association.21 This work, performed in collaboration with experts from many disciplines, resulted from years of work in perioperative safety and quality. It was driven in large part by the FOCUS initiative and exemplifies the leading role that anesthesiologists can take in this vitally important clinical area.
THE FOCUS INITIATIVE: LESSONS LEARNED
The knowledge gained from the various FOCUS projects has been summarized in 10 peer-reviewed manuscripts published over the past 4 years.5–8,11,12,15,16,22,23 A summary of these publications and their most relevant findings is provided in Table 1. Here, we highlight the overarching themes that have emerged through the FOCUS initiative and the process of studying hazards in the CVOR. Quality improvement work in the CVOR is often slow and difficult: This is perhaps not surprising because improving quality and safety in health care in general has been difficult and progress has been slow. Many reasons have been cited for this, but they could all be summarized by the fact that we have not invested enough time, money, and effort in the “science of improvement.”24,25 A multidisciplinary approach is needed: The solutions to safety problems are generally complex and require a multidisciplinary approach.8 Every project described above includes researchers from disciplines such as industrial
engineering, human factors engineering, health care architecture, and industrial psychology. While other industries have a long history of identifying safety hazards and designing solutions with multidisciplinary input, this approach is relatively new in perioperative medicine, but one that is essential if long-lasting, meaningful solutions are to be designed and implemented. We are less familiar with the methodology required for this type of work: Structured observational research is a term used to describe the activities of an individual or a team of researchers who “live” alongside a given workforce, observing and systematically recording how they behave.26 It has been used in several settings to understand individual, team, and organizational precursors of adverse events. The data collected are mostly qualitative, but quantitative (statistical) analysis is also performed. This form of research, which may be considered a form of adapted and extended ethnography (a discipline originally developed by social scientists), is less familiar to the broader health care and research communities. We lack taxonomies: The data we collect through this type of research are often difficult to categorize. This is important when prioritizing and designing interventions. In this regard, the FOCUS projects outlined here have provided valuable contributions to this field by presenting a clear framework for organizing hazards and flow disruptions.8,15,23 These taxonomies will aid in the development of data-driven interventions based on established human factors principles. We do not have enough data: Without data, inferences about what constitutes unsafe care are only assumptions or “armchair guessing.” Drawing an analogy from clinical medicine, this would be the equivalent of writing a prescription without making a diagnosis. Additionally, many proposed interventions to improve safety are never tested for efficacy but are simply mandated by local or national entities, only to find out years later that they are ineffective. The data obtained through the various FOCUS projects will allow us to quantify hazards and design and prioritize interventions to mitigate them.
Figure 2. FOCUS initiative timeline with its 5 major projects. Each shade of blue corresponds to a different strategic goal. FOCUS = Flawless Operative Cardiovascular Unified Systems.
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Quality and Safety in Cardiac Surgery: The FOCUS Initiative
Table 1. FOCUS-Related Publications and Key Findings Year Publication title 2010 Bring your life into FOCUS!6
Publication type Journal Editorial Anesthesia & Analgesia Commentary Anesthesia & Analgesia
2010 The Society of Cardiovascular Anesthesiologists’ FOCUS initiative: locating errors through networked surveillance (LENS) project vision7 2011 Human error in medicine: change Commentary in cardiac operating rooms through the FOCUS initiative5 2011 High stakes and high risk: a Review Article focused qualitative review of hazards during cardiac surgery8
2011 Cardiac surgery errors: results from the United Kingdom National Reporting and Learning System11 2012 Identifying and categorizing patient safety hazards in cardiovascular operating rooms using an interdisciplinary approach: a multisite study15 2012 Variation in local institutional review board evaluations of a multicenter patient safety study16
2012 Using human factors engineering to improve patient safety in the cardiovascular operating room22 2013 Technologies in the wild (TiW): human factors implications for patient safety in the cardiovascular operating room12 2013 Realizing improved patient care through human-centered operating room design23
2013 Patient safety in the cardiac operating room: human factors and teamwork; a scientific statement from the American Heart Association21
2014 Locating errors through networked surveillance: a multimethod approach to peer assessment, hazard identification, and prioritization of patient safety efforts in cardiac surgery20
Key findings • Briefly summarizes the problem of human error in medicine and introduces the FOCUS initiative as the SCA’s effort to improve cardiac surgery safety • Describes the LENS Project vision and overall strategy
• Provides preliminary results of prospective observations of hazards The Journal of in the cardiac OR performed by the LENS investigators Extracorporeal Circulation Anesthesia & • A qualitative literature review that identifies 55 articles on cardiac OR Analgesia hazards and classifies them using the SEIPS taxonomy • Discusses the varied methods of data collection, taxonomies for organizing these data, and different approaches for analysis • Key findings include poor teamwork, violations of safety standards, and deficiencies in safety climate • Only one report identifies medication errors; there are no reports of hazards introduced by tools and technology • This voluntary incident reporting system includes 983,660 incidents, of International Retrospective which 4828 (
