Improving Safety

8 

Improving Safety CHARLOTTE WOODS-HILL, MD; GEOFFREY L. BIRD, MD, MSIS

I

n 2000 the Institute of Medicine’s (IOM) landmark publication To Err Is Human made headlines around the nation with its assertion that nearly 100,000 people died each year in the United States due to medical errors.1 Crossing the Quality Chasm, published 1 year later, identified safety as the first dimension of health care quality, without which the subsequent dimensions cannot be reliably achieved.2 In the years since then, appreciation in the medical community of the real scope of preventable patient harm has only deepened. It truly is an epidemic—a 2013 study examining data from 2008 to 2011 suggests that 200,000 to 400,000 Americans experience death or premature death due to medical error each year.3 Patient safety and preventable patient harm have become topics of the utmost importance to both the medical community and the general public, particularly as more institutionspecific outcome metrics and adverse event data are readily accessible with a simple Internet search.4 The morbidity related to medical error in hospitalized pediatric patients is less certain, but most assuredly is not insignificant. In a retrospective review of 15 pediatric intensive care units (PICUs) across the United States, Agarwal et al.5 found that over 60% of PICU patients experienced an adverse event, 45% of which were deemed preventable and 10% of which were either life threatening or permanent. Patients in a PICU are known to be at increased risk of nosocomial infection.6 In addition, estimates of adverse drug events in PICU patients range from 22 to 59 per 1000 doses, with up to 11% of those events being of life-threatening severity.7,8 When specifically assessing the risk of preventable medical error for a child with cardiac disease, there is a relative paucity of incidence data. There is agreement that adverse events and medical errors do occur in cardiac surgery, owing to its high work load, complexity of involved tasks, and tendency of management plans to be uncertain and subject to change.9 It is reasonable to suspect that given their fragile underlying physiology and the high-risk procedures they often require, pediatric cardiac intensive care unit (PCICU) patients are particularly vulnerable to medical error.10 Jacques et al.11 examined the clinical course of 191 patients with hypoplastic left heart syndrome (or physiologic equivalent) between 2001 and 2011 for errors that could impact patient outcome, and the most striking findings included the following: Errors were common overall, with nearly a quarter of patients experiencing a postoperative error (with delay in recognizing or managing a clinical scenario, error relating to airway management or extubation, and failure of attempted delayed sternal closure being most prevalent); the majority of postoperative errors were considered foreseeable; and postoperative errors were associated with increased risk of death or transplant. 64

Pediatric cardiac surgery clearly is a high-risk specialty with a very small margin for error, and the nature of the work—complex procedures taking place within a sophisticated organizational structure, dependent on frequent multidisciplinary collaboration, and tasking individuals with high-level technical and cognitive responsibilities—may lend itself to the human factors engineering and crew resource management approaches long used in aviation.12 In this vein, Hickey et al.13 took an innovative approach, applying the “threat and error” model of the National Aeronautics and Space Administration (NASA) to over 500 pediatric cardiac surgical admissions. This demonstrated that fully half of cases contained one or more errors and that cycles with multiple errors were very significantly associated with permanent harmful end states, including residual hemodynamic lesions, end-organ injury, and death. Given the mounting evidence that hospitalized children are indeed at risk of medical error and its accompanying morbidity, it is paramount that every pediatric provider actively share in the responsibility to improve patient safety. There is perhaps no clinical environment in which this recognition—that improving patient safety is a shared, fundamental obligation—is more critical than in the perilous world of cardiac surgery. This chapter aims to introduce the reader to a selection of essential concepts and frameworks necessary to provide the safest possible care for pediatric cardiac patients, beginning with a review of key definitions and essential principles relating to patient safety and preventable patient harm, followed by a discussion of selected safety issues unique to a pediatric cardiac patient. First, error, adverse event, and other key terms are defined and categorized in a useful taxonomy from original work by Kohn et al. in To Err Is Human (Table 8.1).1 In the years following the original IOM report, work by Reason and others has proposed that both human and nonhuman factors (i.e., systems), and the interaction of the two, are key in the origin of the majority of medical errors.10 The concept of an organizational or systems-level analysis of adverse events in health care is fundamental to current approaches to increasing patient safety. Health care providers are likely familiar with Reason’s famous “Swiss cheese” model of patient safety,14 which is based on analysis showing that accidents are rarely the result of individual errors, but rather multiple errors within a fundamentally flawed system. In a complex system such as health care, both latent errors (due to organizational system or design failures) and active errors (due to an individual’s failure) can occur, and the way to guarantee patient safety is to either prevent the error from occurring or prevent the error from causing harm through the application of multiple steps that function as a safety net.15 The steps required to verify and dispense a medication

CHAPTER 8  Improving Safety



TABLE 8.1 Patient Safety

Basic Language of Patient Safety Freedom from accidental injury; ensuring patient safety involves the establishment of operational systems and processes that minimize the likelihood of errors and maximize the likelihood of intercepting them when they occur.

Adverse Event

An injury resulting from a medical intervention.

Error

Failure of a planned action to be completed as intended or use of a wrong plan to achieve an aim; the accumulation of errors results in accidents.

Active Error

An error that occurs at the level of the frontline operator and whose effects are felt almost immediately.

Latent Error

Errors in the design, organization, training, or maintenance that lead to operator errors and whose effects typically lie dormant in the system for lengthy periods of time.

System

Set of interdependent elements interacting to achieve a common aim. These elements may be both human and nonhuman (equipment, technologies, etc.).

Human Factors

Study of the interrelationships between humans, the tools they use, and the environment in which they live and work.

From The Institute of Medicine. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Washington, DC: The National Academies Press; 2000:26.

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• BOX 8.1  Characteristics of High-Reliability

Organizations

Preoccupation with failure (being highly aware of all error and potential for error) Reluctance to simplify (understanding and appreciating the complexity of the work) Sensitivity to operations (awareness of the work being done on the front lines) Commitment to resilience (having the capacity to identify, contain, and improve from error) Deference to expertise (allowing frontline workers to make decisions, avoid rigid hierarchies) Modified from Hershey K. Culture of safety. Nurs Clin North Am. 2015;50:139-152; Weick KE, Sutcliffe KM. Managing the Unexpected: Assuring High Performance in an Age of Complexity. San Francisco: Jossey-Bass; 2001.

patient safety. As increasing attention has been paid to the frequency of adverse events in pediatric patients, it has become apparent that the definitions of adverse event and preventable adverse event and the ability of teams to consistently evaluate for “preventability” vary significantly.17 Intriguing approaches to better define and identify adverse events using “trigger tool” methodology and targeted retrospective chart review have been piloted, but at this time much of what we know about incidence of preventable harm in hospitalized pediatric patients comes from incident reporting systems, which are subject to underreporting and other limitations.17

Embedding a Culture of Safety Into Pediatric Cardiac Intensive Care dose on an inpatient ward is a simple example of how medicine applies this safety net concept into daily work flow. Both the ordering clinician and a pharmacist independently verify the dose to be correct and appropriate for the patient and not in violation of the patient’s medication allergy profile. A modern electronic medical record typically has built-in dose maximums and automatic warnings that notify a clinician if the chosen dose falls outside of typical prescribing norms. Often, two nurses also independently verify the medication name, dose, route, patient identifier, and infusion pump settings before administering the medication to the patient. These steps are designed not necessarily to prevent a clinician from ever inadvertently ordering an incorrect medication dose (which would represent a focus on active error) but to reduce the likelihood that an incorrect dose will ever reach and harm a patient via intentional system redundancies and double checks (a contrasting focus on latent error). This model has become hugely popular as a model of accident causation in many industries, including health care, and does offer useful constructs for understanding the constant interplay between individual humans and larger organizational systems, and how each may contribute to adverse events. There is, however, debate in the literature about its validity, particularly regarding its potential to oversimplify events and concern that it has swung the pendulum too far toward placing responsibility for accidents or errors on senior management, versus individuals at the “front lines.”16 Although the definitions and mental models described earlier are a useful starting point, readers should also heed a note of caution about the imperfect standardization of the language of

Lessons From “High-Reliability Organizations” Embracing the concept of a “culture of safety” is fundamental to institution- or unit-level efforts to reduce preventable patient harm. The Agency for Healthcare Research and Quality (AHRQ) reports that the term culture of safety first originated with high-reliability organizations (HROs)―organizations that operate with high potential for error but few adverse outcomes, typically used to mean nuclear or aviation industries.18 In its current state, medicine is alarmingly far from establishing operating margins of safety comparable to these HROs. As a striking comparison from Weick and Sutcliffe,19 the 400,000 people who die annually due to hospital-associated preventable harm is the equivalent of two 747 passenger jets crashing every day, every year—numbers that would bring air travel to a grinding halt, yet health care continues unaffected. HROs are defined by Weick and Sutcliffe as sharing the core characteristics listed in Box 8.1, on a foundation of mutual trust.18,19 When evaluating if the concepts of HROs can translate fully to medicine, one should acknowledge one important limitation from the start. A core principle of the concept of reliability is to focus on defects (errors or adverse events) that can be measured as rates (defects as the numerator, population at risk as the denominator) and are free from reporting bias.20 In applying reliability to health care, this focus translates well to problems with clear operational definitions and that occur at discrete points in time, such as central-line associated bloodstream infections. In truth, most patient safety issues do not lend themselves to

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measurement in this manner.20 This distinction may be part of why the success of efforts to transform medicine into an HRO has been somewhat limited to date.21 A great deal may be gained for health care, however, by understanding the organizational culture at the heart of HROs. Fundamentally, an HRO is a system that has developed a culture sensitive to safety that enables employees to maintain a low probability of adverse events despite unpredictable threats.22 Within an HRO exists an expectation of employees to routinely question practices and search for anomalies that may create risk for error, to refuse to oversimplify safety issues, to work collaboratively and in deference to expertise rather than a rigid organizational hierarchy, and to create solutions when error does occur—essentially, to view reliability as a continuous, ongoing, and active pursuit rather than a simple numeric measure of past performance.22,23 Embedding this culture into the practice of medicine has real potential to change patient outcomes for the better. Roberts et al.24 published a compelling case report of a sustained decrease in mortality and serious safety events in a tertiary care PICU after adoption of HRO principles, followed by a recrudescence of such adverse events after a leadership change in the unit and abandonment of the HRO approach. Anesthesia may also be particularly suited for the introduction of the HRO model to reduce serious safety events.24 Clearly there are differences between aviation and health care that may require alterations in HRO-based methodology. Scheduled operation of a machine that is assumed to be functioning at peak performance is quite distinct from guiding an unexpectedly deteriorating human being from illness to health. However, the principle of high reliability—ability to perform with minimal adverse events despite high risk—is something that health care should certainly endeavor to embody. Indeed, if “the only realistic goal of safety management in complex health-care systems is to develop an intrinsic resistance to its operational hazards,” HROs can provide a road map for building this intrinsic resistance.25 The existing body of evidence for implementing HRO principles in the practice of medicine, though small, mandates our attention as we strive to reduce adverse outcomes for our patients.24

Defining and Building a Culture of Safety for Health Care Specific to health care, the Joint Commission has defined safety culture as “the summary of knowledge, attitudes, behaviors, and beliefs that staff share about the primary importance of the wellbeing and care of the patients they serve, supported by systems and structures that reinforce the focus on patient safety.”26 Several key themes emerge when reviewing literature on how to construct a safety culture in health care. First, there is a clear emphasis on examining medical errors through the lens of health care systems and how systems and individual workers intersect in ways that may be either predisposing to, or protective from, error. Returning back to Reason’s foundational work, individual error is referred to as active error and is committed by a frontline health care worker at the so-called sharp end of health care, whereas systems error is latent error, originating from someone or something remote from direct patient care (such as managers, system designers, or administrators).27 According to Reason, systems-based or latent errors are the greatest threat to complex industries like health care and are the root cause of most error.27 There certainly is a growing body of evidence that nontechnical errors are more prevalent in health care delivery than technical errors and are driven the majority of the time by communication

breakdowns or by problematic team dynamics.28 Catchpole et al.29 found evidence that the primary threat to quality in pediatric cardiac surgery is error related to cultural and organizational failures. Indeed, some go so far as to suggest that “the need to implement effective health care organizing has become as pressing as the need to implement medical breakthroughs.”30 Health care is a dynamic system, with a basic structure and organization into which individual workers bring their own attitudes, behavior, and knowledge. Both parties impact the other continuously, and a focus solely on individual workers as the cause of medical error will be less effective than a strategy that acknowledges the critical interplay between systems and individuals that constantly occurs during patient care. Second, Chassin and Loeb31 propose three central attributes of a safety culture that reinforce one another: trust, report, and improve. Team members must trust their colleagues and their management structure to feel safe in speaking up about unsafe conditions that may endanger patients. Trust will be strengthened when frontline workers see that improvements have been made based on their concerns. Unfortunately, trust is not a given in all health care systems. The 2013 National Healthcare Quality Report found that many health care workers still believe that mistakes will be held against them, and in that same report, half of respondents reported no adverse events at their facility in the preceding year—a number that seems quite low, raising concern that fear of blame may lead to underreporting of medical error and continued risk to patients.32 A culture of blame—one in which fear of criticism or punishment fosters an unwillingness to take risks or accept responsibility for mistakes—simply can no longer be tolerated in a health care system striving to improve patient safety.29 A focus on blame perpetuates silence in the face of near misses and performance problems, ensuring that patients continue to be at risk of preventable harm; a just culture, in contrast, provides a supportive environment in which workers can question practices, express concerns, and admit mistakes without suffering ridicule or punishment.33 Underlying issues like trust and fear of blame is the larger construct of communication within health care systems. Communication barriers are one of the biggest safety challenges that critical care teams face.34 As this fact has become increasingly studied and better understood, the old paradigm of the physician as the unquestioned captain of the team is, in safety-focused health care environments, gradually giving way to new communication strategies that prioritize care delivery over hierarchy. For example, familycentered rounds include parents/caregivers in daily discussions of progress and plans for the patient and have been shown to improve family satisfaction, discharge planning, and communication.35 Including a daily goals sheet or checklist during rounds improves team cohesiveness, helps customize daily care plans to the specific needs of each patient, prompts regular review of simple but important safety items like central venous catheter duration or need for venous thromboembolism prophylaxis, and has been shown in some studies to decrease intensive care unit (ICU) length of stay.35 Employing structured communication frameworks to convey changes in patient status or clinical concerns, such as the popular “SBAR” (situation, background, assessment, recommendations) tool, can improve situational awareness, reduce problems related to organizational hierarchy and experience, and improve collaboration between nurses and physicians.36 Finally, the concept of accountability is also fundamental to a safety culture in health care. Workers must feel empowered to hold not only themselves but also their coworkers to shared high standards in a manner that engenders transparency rather than

CHAPTER 8  Improving Safety



• BOX 8.2  Key Components of an Effective Event-

Reporting System

Institution must have a supportive environment for event reporting that protects the privacy of staff who report occurrences. Reports should be received from a broad range of personnel. Summaries of reported events must be disseminated in a timely fashion. A structured mechanism must be in place for reviewing reports and developing action plans. Reprinted with permission of AHRQ PSNet. Key Components of an Effective Event Reporting System. Reporting Patient Safety Events. Patient Safety Primers. AHRQ Patient Safety Network Web Site. Available at: https://psnet.ahrq.gov/primers/primer/13.

attempts to assign blame. For example, the Joint Commission Center for Transforming Healthcare focuses on accountability as a key strategy to improve hand hygiene performance, a simple practice that is known to reduce incidence of hospital-associated infections yet one for which compliance rates are only around 40%.37 Many hospitals have implemented programs that encourage any observer (including patients and families) to speak up if they note that hand hygiene was not performed before patient care. More broadly, safety event reporting systems discussed in the next section provide a method for concerned team members to report issues of various types for review. Actively giving and openly receiving feedback on issues relating to patient safety is an essential part of a safety culture in health care.

Safety Reporting Systems and Approaches to Analyzing Patient Safety Events Patient safety incident reporting systems are now common in hospitals, increasingly embedded into electronic medical records or Web-based technology, and are fundamental to detecting safety events.38 AHRQ proposes four key elements for an effective safety event reporting system (Box 8.2).38 Error-reporting systems can take many forms—voluntary or mandatory disclosures of events as they occur, automated surveillance, or chart review. Voluntary and mandatory reporting systems are common. Advantages of these kinds of systems are that they often permit any type of health care worker, regardless of position, to make a report, and that they may remove fear of punishment for speaking up by allowing reporting to be anonymous. Limitations include recall bias and underreporting—the latter often due to perception that little or no follow-up will occur after a report is made.38 This perception highlights that having a system in place for reporting safety events accomplishes little if not paired with a robust method for analyzing and addressing the content of the reports. A brief discussion of a select few approaches for safety event review with which the pediatric cardiac intensivist should be familiar follows. Root cause analysis (RCA) and apparent cause analysis (ACA): RCA is a commonly used, formally structured approach to safety event analysis, originating in industrial accidents but now widely applied to health care. It is a retrospective, systems-based method to identify both active and latent error. RCAs typically start with data collection, then detailed reconstruction of how the events leading to the event in question occurred (the active errors), why the events occurred (the latent errors), with the end goal of eliminating the latent errors to prevent the adverse outcome from recurring.39

67

The Joint Commission has mandated RCAs be done for sentinel events since 1997. Although RCAs are widely used, evidence for RCA effectiveness is fairly limited, and there is concern that the significant resources required to carry out RCAs is not balanced by the results they yield, given that follow-up and corrective actions are often inconsistently implemented and vary widely across institutions.40 Related to the concept of RCA is ACA, a more limited investigation employed for less severe adverse events. ACAs may be done more quickly and by a broader range of staff members than RCAs, but as with RCAs, their impact is dependent on the quality and rigor with which they are followed up. Failure modes and effects analysis (FMEA): Originating from engineering, FMEA is, in contrast to RCA, a prospective process that uses five steps to identify potential vulnerabilities in a health care process and to subsequently test the proposed solutions to ensure no new or continued risk to patients.41 The basic steps for FMEA in health care consist of defining a topic (a process or situation thought to represent a potential safety risk), assembling a multidisciplinary team, graphically describing the process with a flow diagram, conducting a hazard analysis (reviewing any/all ways in which the process in question may fail and compromise patient outcomes), and finally developing actions and outcome measures.43 The FMEA model has been associated with successful reduction of postanesthesia complications, improved safety in radiology departments, decreased error in chemotherapy orders, and safety gains in many other components of health care delivery.42-44 Structured morbidity and mortality reviews: This is a general categorization of a helpful construct—that of approaching traditional “M&M” conferences with a specific structure to better uncover and deconstruct issues underlying serious safety breaches. A growing body of evidence suggests a structured morbidity and mortality conference can be a driver of quality improvement initiatives and practice changes that increase patient safety.45-47 This objective can be accomplished in many ways; the reader is directed to resources on the specifics of two selected examples, the Learn From Defects Tool and Ishikawa diagrams, for detailed description of these methods and how to implement them.48-50 Threat and error management: Edward Hickey has suggested an intriguing new approach to preventable patient harm that draws direct lessons from the safety culture of the airline industry. Aviation experts recognize and accept that error is “ubiquitous, inevitable, and needs to be managed”—trained observers of over 3500 commercial flights have concluded that 80% contain error.51 This model stands in contrast to the traditional approach of the medical profession to underestimate frequency of errors, to view errors as stemming from personal failure, and to resist making errors and their impacts transparent to the public.51 The concept of threat and error management is a tactic that therefore encourages medical teams to actively seek error and review all patient cases, rather than focus only on morbidities and mortalities.51 Hickey’s group instituted a model of real-time assessment of every pediatric cardiac surgical patient and included a combination of third-party review of active clinical management, weekly discussion of each patient in an open forum, and preoperative completion of a “flight plan.” The flight plan is how the medical team views each patient’s hospital course and contains a description of the potential threats for that specific case and the operative intentions and models the patient’s projected journey from operating room (OR) to ICU to discharge, similar to an aircraft’s intended flight plan.51 When 524 consecutive patient “flights” were analyzed, 70% had threats; 66% had consequential errors; and 60% of consequential errors led to a chain of further error and progressive deviation from the ideal flight plan.51 These

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findings suggest that as in aviation, it is these chains of events that lead to progressive loss of safety margins and increasing danger of adverse outcomes. Halting such a chain requires the ability to recognize when one is in such a cycle and active effort to rescue the situation using the principles of crew resource management—nontechnical skills that are mandatory for airline pilots and crews but which medicine has yet to embed into training or practice.51

The PCICU is particularly vulnerable to adverse safety events, given that the patients are a heterogeneous population with a variety of anatomy, physiology, ages, and management needs, being cared for in a dynamic, complex environment where medical, surgical, nursing, pharmacy, respiratory therapy, and myriad other teams must collaborate seamlessly to provide care in critical scenarios. Information must be transferred accurately between providers, often coordinated between an operating theater or catheterization laboratory and the ICU, and decisions about the plan of action are often required rapidly in the face of emerging clinical information. To minimize the occurrence of events that cause preventable morbidity or mortality, a PCICU must recognize the high-risk state it is continually operating in and mitigate this risk with continuous attention to safety principles throughout the provision of care to every patient. Particular consideration should be devoted to the following three components of care that are especially fraught with risk for unintended patient harm: team dynamics, surgical handoff, and hospital-acquired infections.

by much more than simply a good leader. Effective teams are committed to achieving clear and specified goals, are composed of diverse members with complementary skill sets, maintain situational awareness despite dynamic or evolving events, expect the unknown, and demonstrate consistent trust and respect between members.54 The importance of the concept of situational awareness cannot be overstated. It is defined in health care as a comprehensive and coherent representation of the patient’s current status and is continuously updated by way of repetitive reassessment.54,56 Accurate situational awareness is essential to successful cardiac surgical care, facilitating a shared mental model of a patient’s status for all team members to carry through from preoperative evaluation to the OR and into postoperative ICU management. Evaluating the performance of health care teams is necessary but not without significant challenges. Guided debriefing, review of recorded clinical encounters, simulated scenarios, and the use of trained observers are examples of common approaches, but in general, few well-defined validated metrics are available for assessing team performance in complex tasks such as resuscitation or during unexpected surgical complication.54 Simulation has long been standard in training for high-risk fields like aviation and the military, and there is growing recognition of its benefits in medicine as well. High-fidelity simulation in particular aims to create realistic clinical scenarios by using sophisticated mannequins that demonstrate a wide range of physiologic responses. Such simulations are designed to induce reactions from the learner that are similar to those that occur during real patient care encounters, and to do so while providing a safe environment and the freedom to fail without endangering live patients.57,58 There is growing appreciation that both simulation and crew resource management courses can aid surgical teams in acquiring essential skills in the nontechnical domains that underlie a great deal of adverse patient events (adaptability, prioritization of tasks, communication, performance monitoring, situational awareness, conflict resolution), and the implementation of this type of education will likely continue to increase.54

Team Training, Teamwork, and Simulation

Surgical Handoff—Risk and Opportunity

Poor teamwork and communication are known to contribute to adverse patient events, whereas team training and debriefing have been demonstrated to reduce mortality.52 Understanding, evaluating, and improving team performance has subsequently emerged as a top priority in institution- or unit-level safety work. Cardiac surgical team performance is particularly critical, given the wide range of providers, equipment, and environments that are called on to assemble quickly and navigate complex cases under severe time constraints.53 In effective teams a team leader is clearly identified and is proficient in the following skills: prioritizing and delegating tasks, supervising the progress of both patient and team throughout the clinical encounter, formulating the definitive treatment plan (via analysis/synthesis of information presented to the leader from various sources and in coordination with consulting services), and keeping all team members aware of that evolving treatment plan.54 Work in aviation has demonstrated that teams whose leaders have attributes termed the right stuff (active, self-confident, empathetic, possessing interpersonal warmth, seeking challenging tasks, and striving for excellence) perform better than teams led by individuals who are authoritarian, arrogant, impatient, or unassertive, another useful lesson for health care that has yet to be well integrated into routine performance.55 Strong team performance, however, is driven

Perhaps no event outside of the surgical procedure itself is as fraught with risk for adverse events as the process of OR-to-PCICU handoff. Three domains—physical equipment, clinical information, and clinical ownership/responsibility—are simultaneously transferred during a time of significant hemodynamic and physiologic vulnerability.59 Accordingly, much effort has been undertaken to standardize this process and embed into it multiple safeguards against patient harm during this critical event. A standardized method for OR-to-PCICU handoff has been shown to increase patient safety in multiple ways: by improving teamwork, decreasing technical errors, helping to ensure complete transfer of information, and reducing distractions and interruptions during handoff discussions.59-63 Although individual hospitals are encouraged to tailor their handoff process to the specifics of their work environment, the Formula 1–style handoff is often cited in discussion about the concept of a standardized OR-to-PCICU transfer of care and provides useful lessons. The pit stop in Formula 1 car racing is an event in which a multidisciplinary team comes together to perform a complex task (change four tires and refuel the car) under intense time pressure (7 seconds) and must do so with minimal error.60 Similarly, for pediatric cardiac surgery a multidisciplinary

Specific Safety Issues for the Pediatric Cardiac Intensive Care Patient: Team Performance, Surgical Handoff, and Nosocomial Infections Complexity of the Cardiac Intensive Care Unit Environment

CHAPTER 8  Improving Safety



group of surgeons, anesthesiologists, and ICU staff meet at the bedside and work as a united team to efficiently and safely transfer equipment, information, and responsibility with minimal error. Catchpole et al.60 engaged directly with the Formula 1 racing team (Ferrari F1) to watch practice pit stops and visit the team headquarters; conducted detailed discussions with the race director; reviewed safety themes that were common between racing and health care; and identified new practices through subsequent collaborative discussions with anesthetists, surgeons, intensivists, and nurses. This work led to a new conceptualization of four critical phases of patient handover: (1) preparation of monitors, equipment, medications, and fluids before patient arrival in the PCICU and regular updates from the OR team to the receiving PCICU team about the patient’s status; (2) physical transfer of patient and equipment from OR systems to the PCICU systems before any verbal transfer of information, minimizing time the patient is unmonitored and off the ventilator; (3) once all team members are ready, verbal transfer of clinical information in a “sterile cockpit” environment—only one person speaks at a time and only patient-specific conversations occur; and (4) questions, clarifications, and concerns are addressed before the receiving team formally accepts responsibility for the care of the patient.59,60 Rates of both technical errors and communication errors decreased after introduction of Catchpole’s Formula 1 framework (depicted in Fig. 8.1) to pediatric cardiac surgical handover, and it is considered foundational to work that strives to improve handover in multiple disciplines.60

In addition to the process framework, the use of a formal, structured handoff tool to transition patients from the OR to the PCICU is strongly encouraged. Multiple studies have demonstrated improvement in communication quality and accuracy and in patient outcomes when such a tool is in place.62-64 See Fig. 8.2 as an example, though these tools can and should be customized to the needs of individual institutions and units.

Nosocomial Infections in Children With Cardiac Disease Postoperative infection complicates up to 8% of surgical procedures for children with acquired or congenital cardiac disease and is a significant cause of morbidity and mortality.65,66 Recent single-center work by Turcotte et al.67 demonstrated that 6% of pediatric cardiac surgical cases had a documented health care–associated infection (HAI) within 90 days of surgery, and the infections were most frequently found to be central line–associated bloodstream infections (CLABSIs), followed by non-CLABSI bacteremia, infective endocarditis, ventilator-associated pneumonia, and surgical site infections (SSIs). HAI in pediatric cardiac surgical patients may increase hospital length of stay and costs, and nosocomial bloodstream infection in particular has been associated with an increase in mortality rate from 2% to 11%.68,69 Given that both patient outcomes and use of hospital resources are affected negatively by HAI, a great deal of effort on a national scale has focused on reducing or preventing these infections. Hospitals that participate in the Centers for Medicare and Medicaid

1 Car stopped 2 Car up on jack 8 Car down off jack 7 Driver readied 9 Driver cleared to go “Lollipop” 5 New wheel on man

Monitor Ventilator ODA Consultant anesthetist

Power

STOP

3 Wheel nut off 6 wheel nut on

Anesthetic registrar

4 Old wheel off 3–6 Driver’s visor cleaned

Pump

Drain

3–6 Fuel in

Pump

Receiving nurse/ registrar

Nurse

Nurse

A

Urine

B • Figure 8.1

69

  Formula 1 pit stop (A) and its adaptation for postoperative cardiac surgical handoff (B). ODA, Operating department assistant. (From Catchpole KR, de Leval MR, McEwan A, et al. Patient handover from surgery to intensive care: using Formula 1 pit-stop and aviation models to improve safety and quality. Pediatr Anaesth. 2007;17:470-478.)

Surgeon

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OR to CICU sign out

Present (OR team): Surgeon Anesthesiology Perfusionist Present (CICU): Attending APN Nurse RT *Sign out time out: Are we ready for sign out: OR team ICU med team ICU nursing team Patient name Diagnosis/problems Surgical repair

MR#

Pertinent past history PMHx

Airway/respiratory Endotracheal tube size Ventilator setting PIP Baseline SpO2 Precautions/plan:

Age

Weight

Pre-op medications

kg

Room silence

Date

Allergies

Laryngoscope miller / mac depth cm PEEP Rate FiO2 NO ppm Most recent SpO2 Most recent ABG pH /pCO2

Airway easy / difficult /pO2

/HCO3

Cardiovascular Access: PIV Arterial catheter Central venous catheters Thoracic catheters Times: CPB mins Aortle XClamp mins DHCA mins MUF yes / no ECG rhythms: Pre-CPB NSR / Post-CPB NSR / Inotropic support: None / milrinone load meg/kg/milrinone gu meg/kg/min / Epinephrine meg/kg/min/ Most recent HR Most recent BP CVP/RAP PAP LAP Precautions/plan: Neurologic Pain meds given Precautions/plan:

Last dose

Renal Urine output ml Precautions/plan:

Most recent chemistries

Na

K

Glucose

Hematologic Most recent Hgb Hct Blood products given RBC / FFP / PLTS / CRYO / cell saver / autologous Available RBC / FFP / PLTS / CRYO / cell saver / autologous Precautions/plan: ID Last dose of antibiotic Ancef

mg at

:

/ other

Additional surgical concerns:

• Figure 8.2

Additional anesthesia concerns:

Example of a postoperative surgical handoff tool. (From Joy BF, Feltes TF. The role of communication and patient handovers in pediatric cardiac care centers. In: Barach PR, Jacobs JP, Lipshultz SE, Laussen PC, eds. Quality Improvement and Patient Safety. London: Springer-Verlag; 2015:349-354. Pediatric and Congenital Cardiac Care; vol 2.)

TABLE 8.2

 

Distinguishing Between CommunityAcquired Infections, Nosocomial Infections, and Colonization

CommunityAcquired Infection

Infection present at time of admission, even if not causing symptoms at admission

Nosocomial Infection

Infection acquired during hospitalization and not present on admission

Colonization

Presence of potentially infectious organisms without causing disease or clinical symptoms

Services funding must report rates of CLABSI, catheter-associated urinary tract infection, nosocomial Clostridium difficile infections, and SSI.70 Financial penalties are incurred from state, federal, and private payers when nosocomial infections occur during hospital admission. Accordingly, dedicated clinical teams or working groups

that specifically target preventing and reducing HAI are increasingly common in the inpatient pediatric setting. The reader is encouraged to review the extensive resources on this topic available from organizations like The Joint Commission and the AHRQ. Tables 8.2 to 8.4 and Box 8.3 are an introductory summary of important terms and definitions that the PCICU clinician should understand when considering nosocomial infection as a major contributor to preventable patient harm.71-75

Conclusion Enormous advances have been made in pediatric cardiac care in the last several decades, but preventable harm and adverse events continue to pose a significant threat to patients. Important lessons can be learned from high-reliability organizations that perform safely despite incredibly high risks. Understanding that communication, team dynamics, and standardized best-practice protocols play critical roles in reducing patient harm continues to grow. Medicine must continue to evolve from a culture that tolerates blame and

CHAPTER 8  Improving Safety



TABLE 8.3

Definitions of CLABSI, CAUTI, VAP, and SSI Definition

Notes

CLABSI (central line–associated bloodstream infection)

A laboratory-confirmed bloodstream infection (LCBI) where central line (CL) or umbilical catheter (UC) was in place for >2 calendar days on the date of event, with day of device placement being day 1, AND the line was also in place on the date of event or the day before

LCBI: Patient of any age has a recognized pathogen identified (i.e., an organism that is not on the NHSN common commensal list) from one or more blood specimens by a culture or nonculture based microbiologic testing method AND organism(s) identified in blood is not related to an infection at another site

CAUTI (catheter-associated urinary tract infection)

A UTI where an indwelling urinary catheter was in place for >2 calendar days on the date of event, with day of device placement being day 1, AND an indwelling urinary catheter was in place on the date of event or the day before

See https://www.cdc.gov/nhsn/PDFs/ pscManual/7pscCAUTIcurrent.pdf (for distinguishing symptomatic UTI vs asymptomatic UTI)

VAP (ventilator-associated pneumonia)

A pneumonia where the patient is on mechanical ventilation for >2 calendar days on the date of event, with day of ventilator placement being day 1, AND the ventilator was in place on the date of event or the day before

Pneumonia is identified by using a combination of imaging, clinical, and laboratory criteria. For details, see https://www.cdc.gov/nhsn/pdfs/ pscmanual/6pscvapcurrent.pdf

SSI (surgical site infection)

Superficial SSI Date of event for infection occurs within 30 days after any NHSN operative procedure (where day 1 is the procedure date) AND involves only skin and subcutaneous tissue of the incision AND patient has at least one of the following: a. Purulent drainage from the superficial incision. b. Organisms identified from an aseptically obtained specimen from the superficial incision or subcutaneous tissue by a culture or non–culturebased microbiologic testing method that is performed for purposes of clinical diagnosis or treatment (e.g., not active surveillance culture/ testing [ASC/AST]) c. Superficial incision that is deliberately opened by a surgeon, attending physician, or other designee and culture or non–culture-based testing is not performed AND patient has at least one of the following signs or symptoms: pain or tenderness; localized swelling; erythema; or heat d. Diagnosis of a superficial incisional SSI by the surgeon or attending physician or other designee

Deep SSI Date of event for infection occurs within 30 or 90 days after the NHSN operative procedure (where day 1 is the procedure date) AND involves deep soft tissues of the incision (e.g., fascial and muscle layers) AND patient has at least one of the following: a. Purulent drainage from the deep incision. b. A deep incision that spontaneously dehisces or is deliberately opened or aspirated by a surgeon, attending physician, or other designee and organism is identified by a culture or non– culture-based microbiologic testing method that is performed for purposes of clinical diagnosis or treatment (e.g., not ASC/AST) or culture or non–culture-based microbiologic testing method is not performed AND patient has at least one of the following signs or symptoms: fever (>38°C); localized pain or tenderness. A culture or non–culture-based test that has a negative finding does not meet this criterion. c. An abscess or other evidence of infection involving the deep incision that is detected on gross anatomic or histopathologic examination or imaging test.

NHSN, National Healthcare Safety Network; UTI, urinary tract infection. Modified from Bloodstream infection event (central line-associated bloodstream infection and non-central line-associated bloodstream infection). https://www.cdc.gov/nhsn/pdfs/pscmanual/4psc_clabscurrent. pdf; Urinary tract infection (catheter-associated urinary tract infection [CAUTI] and non-catheter-associated urinary tract infection [UTI]) and other urinary system infection [USI]) events. https://www.cdc. gov/nhsn/PDFs/pscManual/7pscCAUTIcurrent.pdf; Pneumonia (ventilator-associated [VAP] and non-ventilator-associated pneumonia [PNEU]) event. https://www.cdc.gov/nhsn/pdfs/pscmanual/6pscvapcurrent. pdf; Surgical site infection (SSI) event. https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf.

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TABLE 8.4

Systems-Based Intensive Care Unit

Practices Associated With Pediatric CLABSI

Practices Associated With Prevention or Reduction of CLABSI

Practices Not Associated With Prevention or Reduction in CLABSI

Preinsertion hand hygiene and aseptic technique throughout insertion

Routine replacement of catheters

Skin preparation with chlorhexadine

Tight glycemic control

Maximal barrier precautions

Avoiding the femoral vein site in pediatric patients

Placement of a transparent, semipermeable dressing, which is replaced regularly per protocol and when damp/soiled/ loosened Insertion of line with fewest number of required lumens Insertion of antibiotic-impregnated or antiseptic-coated catheters Implementation of formal insertion and maintenance bundles Routine replacement of tubing and infusion sets CLABSI, Central line–associated bloodstream infection. Modified from Custer JW, Siegrist TJ, Straumanis JP. Nosocomial infections in the PICU. In: Nichols DG, Shaffner DH, eds. Rogers’ Textbook of Pediatric Intensive Care. 5th ed. Philadelphia: Wolters Kluwer; 2016:1503-1523.

• BOX 8.3  General Risk Factors for Nosocomial

Infections in Pediatric Intensive Care Unit

Younger age and neonates Prematurity Use of total parenteral nutrition with high glucose concentrations and lipids Compromised immune system such as from chemotherapy, HIV infection, steroid use, etc. Increasing severity of illness score Increasing length of stay Prior antimicrobial therapy Blood transfusion Device utilization ratios Understaffing of the ICU HIV, Human immunodeficiency virus; ICU, intensive care unit. Modified from Custer JW, Siegrist TJ, Straumanis JP. Nosocomial infections in the PICU. In: Nichols DG, Shaffner DH, eds. Rogers’ Textbook of Pediatric Intensive Care. 5th ed. Philadelphia: Wolters Kluwer; 2016:1503-1523.

views errors as personal failures into a culture of transparency, reliability, justice, and ultimately, of safety.

Selected References A complete list of references is available at ExpertConsult.com. 1. The Institute of Medicine. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Washington, DC: The National Academies Press; 2000:26. 2. The Institute of Medicine. Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington DC: National Academy Press; 2001:5. 4. The Joint Commission Center for Transforming Healthcare. Facts about the safety culture project. Available at: http://www .centerfortransforminghealthcare.org/assets/4/6/CTH_SC_Fact _Sheet.pdf. 14. Reason J. Human error: models and management. BMJ. 2000;320(7237):768–770. 19. Weick KE, Sutcliffe KM. Managing the Unexpected: Assuring High Performance in an Age of Complexity. 1st ed. San Francisco: Jossey-Bass; 2001. 38. Patient Safety Primer. Voluntary Patient Safety Event Reporting (Incident Reporting). Available at: https://psnet.ahrq.gov/primers/primer/13. 54. Barach PR, Cosman PH. Teams, team training, and the role of simulation. In: Barach PR, Jacobs JP, Lipshultz SE, Laussen PC, eds. Pediatric and Congenital Cardiac Care Volume 2: Quality Improvement and Patient Safety. London: Springer-Verlag; 2015:69–90. 59. Joy BF, Feltes TF. The role of communication and patient handovers in pediatric cardiac care centers. In: Barach PR, Jacobs JP, Lipshultz SE, Laussen PC, eds. Pediatric and Congenital Cardiac Care: Volume 2: Quality Improvement and Patient Safety. London: Springer-Verlag; 2015:349–354. 60. Catchpole KR, de Leval MR, McEwan A, et al. Patient handover from surgery to intensive care: using Formula 1 pit-stop and aviation models to improve safety and quality. Paediatr Anaesth. 2007;17:470–478. 67. Turcotte RF, Brozovich A, Corda R. Health care-associated infections in children after cardiac surgery. Pediatr Cardiol. 2014;35:1448–1455. 71. Custer JW, Siegrist Thomas J, Straumanis JP. Nosocomial infections in the PICU. In: Nichols DG, Donald H, Shaffner DH, eds. Rogers’ Textbook of Pediatric Intensive Care. 5th ed. Philadelphia: Wolters Kluwer; 2016:1503–1523. 72. Bloodstream Infection Event (Central Line-Associated Bloodstream Infection and non-central line-associated Bloodstream Infection). Available at: https://www.cdc.gov/nhsn/pdfs/pscmanual/4psc_clabscurrent.pdf. 73. Urinary Tract Infection (Catheter-Associated Urinary Tract Infection [CAUTI] and Non-Catheter-Associated Urinary Tract Infection [UTI]) and Other Urinary System Infection [USI]) Events. Available at: https:// www.cdc.gov/nhsn/PDFs/pscManual/7pscCAUTIcurrent.pdf. 74. Pneumonia (Ventilator-associated [VAP] and non-ventilator-associated Pneumonia [PNEU]) Event. Available at: https://www.cdc.gov/nhsn/ pdfs/pscmanual/6pscvapcurrent.pdf. 75. Surgical Site Infection (SSI) Event. Available at: https://www.cdc.gov/ nhsn/pdfs/pscmanual/9pscssicurrent.pdf. Accessed Mar 7, 2017.

CHAPTER 8  Improving Safety



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