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FOCUS

The Society of Cardiovascular Anesthesiologists’ Initiative to Improve Quality and Safety in the Cardiovascular Operating Room

Barbeito, Atilio, MD, MPH*; Lau, William Travis, MD; Weitzel, Nathaen, MD; Abernathy, James H. III, MD, MPH, FASE§; Wahr, Joyce, MD, FAHA; Mark, Jonathan B., MD*

doi: 10.1213/ANE.0000000000000359
Cardiovascular Anesthesiology: Special Article
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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 science-driven improvement in quality and safety. There is a long and arduous road ahead, but one we need to continue to travel.

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 Carolina; 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.barbeito@duke.edu.

In 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, 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.

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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 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.

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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).

Figure 1

Figure 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, 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, one-third 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 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 self-assessments.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

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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 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.

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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 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).

Figure 2

Figure 2

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.

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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.

Table 1

Table 1

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.

The operating room environment is fraught with hazards: Seemingly minor events are extremely common in the CVOR. While the majority do not cause patient harm, they are predictive of major events because they degrade the team’s ability to compensate.6,7,13 Some of the hazards documented by the FOCUS investigators are summarized in Table 2.

Table 2

Table 2

Anesthesiologists are in an optimal position to lead these types of efforts: Given the nature of our work as anesthesiologists, we interact daily with providers from multiple disciplines. This places us in a perfect position to coordinate and lead efforts aimed at improving the quality and safety of the care we provide in the OR, the intensive care unit, and other procedural areas across the medical center.

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FUTURE STEPS

It is clear from the data on hazards and flow disruptions collected thus far that there is a tremendous opportunity to improve safety and quality in the CVOR over the next few years. The tasks we perform are interdependent and are influenced by the skills of individual clinicians, the team, the environment, the tools and technology used, and the organizational culture and resources.8 The layers of risk introduced by this interdependency can be mitigated by instituting formal teamwork training programs, creating standards (protocols, guidelines, care maps), communicating standards internally and externally, ensuring compliance with those standards, creating a safety net of redundancies, and fostering a culture of safety and continuous quality improvement. The SCA, through the FOCUS initiative, has begun this journey of science-driven improvement in quality and safety. There is a long and arduous road ahead, but one we need to continue to travel.

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DISCLOSURES

Name: Atilio Barbeito, MD, MPH.

Contribution: This author reviewed the literature, prepared the manuscript, and designed the figures and tables.

Attestation: Atilio Barbeito approved the final manuscript.

Conflicts of Interest: The author has no conflicts of interest to declare.

Name: William Travis Lau, MD.

Contribution: This author was an active participant in the planning and writing of this manuscript.

Attestation: William Travis Lau approved the final manuscript.

Conflicts of Interest: The author has no conflicts of interest to declare.

Name: Nathaen Weitzel, MD.

Contribution: This author was an active participant in the planning and writing of this manuscript.

Attestation: Nathaen Weitzel approved the final manuscript, including the integrity of the information presented here.

Conflicts of Interest: The author has no conflicts of interest to declare.

Name: James H. Abernathy, III, MD, MPH, FASE.

Contribution: This author was an active participant in the planning and writing of this manuscript.

Attestation: James H. Abernathy approved the final manuscript.

Conflicts of Interest: The author has no conflicts of interest to declare.

Name: Joyce Wahr, MD, FAHA.

Contribution: This author contributed to the design of the review paper, read all the reviewed articles, participated in discussions about the findings of each article reviewed, and helped in manuscript preparation.

Attestation: Joyce Wahr read and approved the final manuscript. Joyce Wahr also attests that the articles reviewed are correctly represented in the review.

Conflicts of Interest: Joyce Wahr is the Chair of the Society of Cardiovascular Anesthesiologists Foundation that has performed much of this work. Although she will not benefit financially, there is a bias to present the work favorably. The SCA Foundation may benefit financially through increased donations, etc. None of the other authors is associated with the SCA Foundation.

Name: Jonathan B. Mark, MD.

Contribution: This author read all the reviewed articles and helped write and edit this manuscript and its figures and tables.

Attestation: Jonathan Mark approved the final manuscript.

Conflicts of Interest: The author has no conflicts of interest to declare.

This manuscript was handled by: Martin J. London, MD.

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ACKNOWLEDGMENTS

This manuscript is dedicated to the memory of Elizabeth Martinez, MD, MHS, a leader of the FOCUS projects, and whose work in improving perioperative patient safety serves as a model for us all.

Elizabeth A. Martinez was a key lead on the FOCUS/LENS project reviewed in this paper. She passed away on September 19, 2013, after a 16-month battle with a rare and aggressive cancer. Elizabeth completed her MD, MHS, anesthesiology residency, and fellowships in critical care and adult cardiothoracic anesthesiology at the Johns Hopkins University. Throughout her career, she dedicated both her clinical practice and her research to improving the quality and safety of care provided to surgical patients. Her research was funded by the Society for Critical Care Medicine, the Agency for Healthcare Research and Quality, the Commonwealth Fund, and the Society of Cardiovascular Anesthesiologists/SCA Foundation. When the Society of Cardiovascular Anesthesiologists published a Request for Proposals to improve the safety of cardiac surgery patients, Dr. Martinez and her mentor, Dr. Peter Pronovost, submitted what would become the basis for the papers reviewed in this article, the Locating Errors through Networked Surveillance (LENS). Her leadership was insightful, important, energizing, and critical to the success of the collaboration. Elizabeth, in the words of Peter Pronovost, was “caring and confidant, humble and brilliant, and committed … she did novel and important research. Without a doubt, her work saved many lives and will continue to save lives.” In her too brief life, she made a tremendous impact on the safety and quality of care that we, as cardiac anesthesiologists, provide to our cardiac surgery patients every day. We miss her passion, her sunny approach to difficult problems, and her wisdom and insight; we also celebrate what she has taught us. We are better doctors because of her work. We are better people because of her life.

Figure

Figure

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FOOTNOTES

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.
Cited Here...

b World Association of Nuclear Operators (WANO), Peer Reviews. Available at: http://www.wano.info/programmes/peer-reviews. Accessed April 21, 2014.
Cited Here...

c The common understanding of roles and functions of each team member, task requirements, and the coordination of activities required for the provision of safe care.

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