Paul Barach

Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems

Reducing mishaps from medical management is central to efforts to improve quality and lower costs in health care. Nearly 100 000 patients are estimated to die preventable deaths annually in hospitals in the United States, with many more incurring injuries at an annual cost of

Five System Barriers to Achieving Ultrasafe Health Care

9 billion. Underreporting of adverse events is estimated to range from 50%-96% annually.1–3 This annual toll exceeds the combined number of deaths and injuries from motor and air crashes, suicides, falls, poisonings, and drownings.4 Many stakeholders in health care have begun to work together to resolve the moral, scientific, legal, and practical dilemmas of medical mishaps. To achieve this goal, an environment fostering a rich reporting culture must be created to capture accurate and detailed data about nuances of care. Outcomes in complex work depend on the integration of individual, team, technical, and organisational factors. 5 6 A continuum of cascade effects exists from apparently trivial incidents to near misses and full blown adverse events. 7 8 Consequently, the same patterns of causes of failure and their relations precede both adverse events and near misses. Only the presence or absence of recovery mechanisms determines the actual outcome.9 The National Research Council defines a safety “incident” as an event that, under slightly different circumstances, could have been an accident.10 Focusing on data for near misses may add noticeably more value to quality improvement than a sole focus on adverse events. Schemes for reporting near misses, “close calls,” or sentinel (“warning”) events have been institutionalised in aviation,w1 w2 nuclear power technology,w3 w4 petrochemical processing, steelw5 production,w6 military operations, and air transportation.w7-w11 In health care, efforts are now being made to create incident reporting systems for medical near misses 8 11–15 to supplement the limited …

Improving patient handovers from hospital to primary care: a systematic review.

Key Summary Points In health care, the premium placed on autonomy, the drive for productivity, and the economics of the system may lead to severe safety constraints and adverse medical events. Several key building blocks must be addressed before other solutions to the problem of unsafe medical care can be considered. Among these building blocks are the need to control maximum production, use of the equivalent actor principle, and the need for standardization of practices. Safety in health care depends more on dynamic harmony among actors than on reaching an optimum level of excellence at each separate organizational level. Open dialogue and explicit team training among health care professionals are key factors in establishing a shared culture of safety in health care. The notion of a 2-tiered system of medicine may evolve logically by distinguishing between health care sectors in which ultrasafety is achievable and sectors that are characterized by ambition, audacity, and aggressive efforts to rescue patients, in which greater risk is inherent in the goals. More than 5 years ago, the Institute of Medicine report To Err Is Human: Building a Safer Health System highlighted the need to make patient safety a major priority for health care authorities (1). Since then, the pressure to increase patient safety has continuously grown in western countries. Priority has focused on identifying and reducing preventable events. Important changes have already been made to the accident and incident reporting system, and the associated techniques of analysis (2-6). However, the upper limit of harm prevention is unclear (7). Many investigators have proposed that adapting the success strategies and tools of ultrasafe systems, such as those used in the aviation and nuclear power industries, will lead to comparable successes and safety outcomes in health care (8, 9). The reality is probably more complicated. Many complex industriesfor example, the chemical industry or road safetyhave adapted the safety tools of advanced systems and made important gains in the past 2 decades. However, the safety results from most of these efforts top out well before the level reached by the civil aviation and nuclear power industries (10). This limit does not seem to be due to insufficient tools, low competence among workers, or naive safety strategies. For the most part, it seems to be the consequence of a conscious tradeoff among safety goals, performance goals, and the organization of the specific profession. Becoming ultrasafe may require health care to abandon traditions and autonomy that some professionals erroneously believe are necessary to make their work effective, profitable, and pleasant. A comparative analysis of industry behavior demonstrates that becoming an ultrasafe provider requires acceptance of 5 overall types of constraints on activity. This analysis is based on the screening of various socio-technical professions, such as the aviation, nuclear power, chemical, and food industries; road transportation; and health care. The benchmark analysis aims to associate specific traits of these industries with their safety performance. We then describe 5 high-level organizational dimensions derived from the general literature on risk and safety (11-13), each of which is associated with a range of values: type of expected performance (from daily routine work to highly innovative, and standardized or repetitive), interface of health care providers with patients (from full autonomy to full supervision), type of regulations (from few recommendations to full specification of regulations at an international level), pressure for justice after an accident (from little judicial scrutiny to routine lawsuits against people and systems), and supervision and transparency by media and people in the street of the activity (from little concern to high demand for national supervision). We consider the value of a given dimension to become a barrier when it is present for all work situations that entail equal or less safety and it is absent for all work situations that entail greater safety. The barriers can be ranged along a safety axis by considering the average safety level of work situations that cannot cross each of these barriers. A barrier may be under partial control and therefore overlap other barriers that are also under partial control, making the relative effect of each barrier on the observed final level of safety more complex. We consider one barrier to be more constraining than another barrier when the maximum safety performance associated with no control at all is lower than that of another barrier. The barriers to safety that we discuss are fundamental, or root, barriers. Addressing each root barrier demands a substantial change in practice that entails considerable economic, political, and performance tradeoffs. Risk Assessment and Communication in Industrial Activities The overall safety profile of an industrial system is measured by reporting on the number of adverse events over a time interval (for example, an annual rate). The figures are generally weighted according to the volume of activity (such as number of miles traveled per year). The variable that is best for specifying the volume of activitythe denominator in a safety calculationis industry specific and is therefore poorly standardized across industries. For example, civil aviation uses 1 million departures as the relevant value to calculate volume of activity, whereas military aviation uses the number of flight hours. Reliable measurement of health care and patient safety outcomes is the first challenge for health care benchmarking (14, 15). In health care, the ethically compelling numerator is preventable harm. In many industries, the weighting process reflects how comfortable the organization or industry is with its risk exposure. For example, the risk for fatal accidents in road traffic, which is 1 of the top 3 causes of death in western countries, is often weighted by convenience of travel and the mileage traveled (16). Use of this denominator may lead to the perception that road transportation is a very safe domain compared with the alternatives. The unwary consumer of such risk reports may therefore erroneously interpret road travel as much safer than modes of travel for which risk is calculated on the basis of a much larger denominator, such as that used in aviation. In fact, air travel is far safer than road travel. We use the rate of catastrophic events per exposure among industrial and human endeavors as an anchor to allow comparison of accident rates across industries with those in health care (Figure 1). Viewed through this lens, accident rates in health care currently range from 101 to 107 events per exposure. This ratio is the most accessible and allows easier comparisons across industries. Figure 1. Average rate per exposure of catastrophes and associated deaths in various industries and human activities. In the civil aviation, nuclear power, and railway transport industries in Europe, the rate of catastrophic accidents per exposure, such as complete failure of an airplane engine leading to loss of aircraft, is better than 1 106. That is, the rate of death in these industries is less than 1 per million exposures. The rate of fatal adverse events among hospital patients is much greater but also varies by domain (1). In obstetrics, anesthesiology, or blood transfusion, the risk for fatal adverse events per exposure is less than 105 (17). Conversely, surgery has a total rate of fatal adverse events of almost 104 (14). Numerous investigators present this 104 risk for accident as an extrapolated average value in health care (18, 19). However, not all statistics have the same validity, because of differences in definitions and comprehensiveness in monitoring methods (20). Some statistics derive from large databases with objective assessment, whereas others derive from local estimates. The latter is particularly true for health care. The rates of adverse events are most likely reasonably convergent in the published literature, but some investigators have pointed out the importance of an accurate numerator and denominator in the calculation (21, 22). For our purposes, however, we believe that these variations do not deeply alter the proposed safety framework. We aim to reason more in terms of relative ranking rather than precise safety values. Moreover, our working hypothesis on the stability of the relative ranking is all the more reasonable because the industries from which we are inferring were chosen on the basis of separation by many logs of safety amplitude. What Are the Limits and Barriers to Achieving Safety in Medicine? Bearing in mind the caveats regarding calculation of risk, the risk for catastrophic events across industries differs greatly. Some sectors continue to have a low safety level (for example, transport by microlight aircraft or helicopter, and emergency surgery), some are stuck at an average safety level (for example, road safety and occupational accidents in trade or fishing), some are at good levels (for example, the petrochemical industry and anesthesiology), and the best have achieved safety levels beyond 106 (for example, the nuclear power and civil aviation industries). Five systemic successive barriers seem to characterize limitations in safety improvement. Barrier 1: Acceptance of Limitations on Maximum Performance The first barrier involves regulations that limit the level of risk allowed. This level is dictated in situations in which high levels of production and performance are also sought. When limits do not existthat is, the prevailing attitude is attain a specified high level of production, no matter what it takesthe system in question is very unsafe. When the maximum performance is unlimited and individuals or systems are allowed to make autonomous decisions without regulation or constraints, the risk for fatal events nears 1 102 p

Integrating patient safety into the clinical microsystem

BACKGROUND Evidence shows that suboptimum handovers at hospital discharge lead to increased rehospitalizations and decreased quality of health care. PURPOSE To systematically review interventions that aim to improve patient discharge from hospital to primary care. DATA SOURCES PubMed, CINAHL, PsycInfo, the Cochrane Library, and EMBASE were searched for studies published between January 1990 and March 2011. STUDY SELECTION Randomized, controlled trials of interventions that aimed to improve handovers between hospital and primary care providers at hospital discharge. DATA EXTRACTION Two reviewers independently abstracted data on study objectives, setting and design, intervention characteristics, and outcomes. Studies were categorized according to methodological quality, sample size, intervention characteristics, outcome, statistical significance, and direction of effects. DATA SYNTHESIS Of the 36 included studies, 25 (69.4%) had statistically significant effects in favor of the intervention group and 34 (94.4%) described multicomponent interventions. Effective interventions included medication reconciliation; electronic tools to facilitate quick, clear, and structured summary generation; discharge planning; shared involvement in follow-up by hospital and community care providers; use of electronic discharge notifications; and Web-based access to discharge information for general practitioners. Statistically significant effects were mostly found in reducing hospital use (for example, rehospitalizations), improvement of continuity of care (for example, accurate discharge information), and improvement of patient status after discharge (for example, satisfaction). LIMITATIONS Heterogeneity of the interventions and study characteristics made meta-analysis impossible. Most studies had diffuse aims and poor descriptions of the specific intervention components. CONCLUSION Many interventions have positive effects on patient care. However, given the complexity of interventions and outcome measures, the literature does not permit firm conclusions about which interventions have these effects. PRIMARY FUNDING SOURCE The European Union, the Framework Programme of the European Commission.

A prospective observational study of human factors, adverse events, and patient outcomes in surgery for pediatric cardiac disease

Healthcare institutions continue to face challenges in providing safe patient care in increasingly complex organisational and regulatory environments while striving to maintain financial viability. The clinical microsystem provides a conceptual and practical framework for approaching organisational learning and delivery of care. Tensions exist between the conceptual theory and the daily practical applications of providing safe and effective care within healthcare systems. Healthcare organisations are often complex, disorganised, and opaque systems to their users and their patients. This disorganisation may lead to patient discomfort and harm as well as much waste. Healthcare organisations are in some sense conglomerates of smaller systems, not coherent monolithic organisations. The microsystem unit allows organisational leaders to embed quality and safety into a microsystem’s developmental journey. Leaders can set the stage for making safety a priority for the organisation while allowing individual microsystems to create innovative strategies for improvement.

Understanding the complexity of redesigning care around the clinical microsystem

OBJECTIVE To explore the impact of human factors on intraoperative adverse events and compensation mechanisms in pediatric cardiac surgery. METHODS Prospective observations of pediatric cardiac surgical procedures were conducted. Patient complexity scores were calculated and outcomes recorded. The process of care was divided into epochs. Events were extracted and coded into compensated or uncompensated major and minor adverse events. Linear regression and analysis of variance were used to analyze the relationships between epochs, complexity, adverse events, and outcome. Patient-specific and procedure-specific variables were tested in a forward stepwise logistic regression as predictors of cases with 1 or more major adverse events. RESULTS One hundred two patients undergoing pediatric cardiac surgery were observed. An average of 1.2 (range 0-6) major adverse events occurred per case. The most common type of major adverse event was cardiovascular, and most occurred during the surgery/postbypass epoch. Cognitive compensation was the most common compensation mechanism for major adverse events. An average of 15.3 minor adverse events occurred per case. Minor adverse events occurred frequently during the surgery/bypass epoch and related to communication and coordination failures. Higher case complexity, longer surgery duration, and higher number of major adverse events per patient correlated with death compared with other outcome groups (P < .01). Case complexity (P < .01) and surgery duration (P < .05) were both significant predictors of major adverse events. CONCLUSIONS Pediatric cardiac surgery is an ideal model to study the coordinated efforts of team members in a complex organizational structure. Adverse events occurred routinely during pediatric cardiac surgery and were mostly compensated. Case complexity was a significant predictor of major adverse events. The number of major adverse events per patient correlated with clinical outcomes.

Evaluating policy and service interventions: framework to guide selection and interpretation of study end points

The microsystem is an organizing design construct in which social systems cut across traditional discipline boundaries. Because of its interdisciplinary focus, the clinical microsystem provides a conceptual and practical framework for simplifying complex organizations that deliver care. It also provides an important opportunity for organizational learning. Process mapping and microworld simulation may be especially useful for redesigning care around the microsystem concept. Process mapping, in which the core processes of the microsystem are delineated and assessed from the perspective of how the individual interacts with the system, is an important element of the continuous learning cycle of the microsystem and the healthcare organization. Microworld simulations are interactive computer based models that can be used as an experimental platform to test basic questions about decision making misperceptions, cause-effect inferences, and learning within the clinical microsystem. Together these tools offer the user and organization the ability to understand the complexity of healthcare systems and to facilitate the redesign of optimal outcomes.

A prospective study of paediatric cardiac surgical microsystems: assessing the relationships between non-routine events, teamwork and patient outcomes

The effect of many cost effective policy and service interventions cannot be detected at the level of the patient. This new framework could help improve the design (especially choice of primary end point) and interpretation of evaluative studies

Postoperative patient complaints: a prospective interview study of 12,276 patients

Objective Paediatric cardiac surgery has a low error tolerance and demands high levels of cognitive and technical performance. Growing evidence suggests that further improvements in patient outcomes depend on system factors, in particular, effective team skills. The hypotheses that small intraoperative non-routine events (NREs) can escalate to more serious situations and that effective teamwork can prevent the development of serious situations were examined to develop a method to assess these skills and to provide evidence for improvements in training and performance. Methods This mixed-method design, using both quantitative and qualitative measures, relied on trained human factor observers who observed and coded NREs and teamwork elements from the time of patient arrival into the operating room to patient handover to the intensive care unit. Real-time teamwork observations were coupled with microsystem preparedness measures, operative duration, assessed difficulty of the operation and patient outcome measures. Behaviour was rated based on whether it hindered or enhanced teamwork. Results 40 paediatric cardiac surgery cases were observed. Surgeons displayed better teamwork during complicated procedures, particularly during the surgical bypass/repair epoch. More procedural NREs were associated with a more complicated postoperative course (Muncomplicated=9.08; Mminor complications=11.11; Mmajor morbidity=14.60, F(2,26)=3.46, p<0.05). Procedural NREs decreased substantially over time (M1=13.5; M2=7.1, F(1,37)=33.07, p<0.001). Conclusions Structured observation of effective teamwork in the operating room can identify substantive deficiencies in the system and conduct of procedures, even in otherwise successful operations. High performing teams are more resilient displaying effective teamwork when operations become more difficult.

Creating effective leadership for improving patient safety.

STUDY OBJECTIVE To evaluate the incidence of perioperative minor adverse events and to analyze patient satisfaction based on potential explanatory variables. DESIGN Structured, face-to-face interview of 25% of all patients undergoing surgery during the period from January 2003 through June 2006. SETTING Academic university medical center. PATIENTS 12,276 patients (5,793 men and 6,483 women) from all surgical disciplines: 7,440 patients had general anesthesia, 4,236 patients had regional anesthesia, and 600 patients had a combined general-regional anesthetic technique. MEASUREMENTS Occurrence of perioperative minor adverse events was assessed during the interview. Patient satisfaction was measured with a 4-point Likert scale. MAIN RESULTS 3,652 (30%) patients reported at least one perioperative complaint and 737 (6%) patients reported multiple minor adverse events. Overall, a total of 4,475 minor adverse events were reported. Leading adverse events included postoperative nausea and vomiting (1,705 complaints), sore throat (1,228 complaints), and hoarseness (802 complaints). Patient satisfaction with anesthetic care was generally high (97% satisfied or highly satisfied). Patients were significantly more satisfied following regional than general anesthesia (P < 0.001). Patient dissatisfaction was also associated with the occurrence of at least one minor adverse event (P < 0.001) or with increasing ASA physical status (P < 0.001). CONCLUSION Minor events occur with a surprisingly high incidence and are significantly associated with patient dissatisfaction. Regional anesthesia is associated with fewer patient complaints and significantly higher postoperative patient satisfaction.