According to W. Edwards Deming, American companies require nothing less than a transformation of management style and of governmental relations with industry. In Out of the Crisis, originally published in 1982, Deming offers a theory of management based on his famous 14 Points for Management. Management's failure to plan for the future, he claims, brings about loss of market, which brings about loss of jobs. Management must be judged not only by the quarterly dividend, but by innovative plans to stay in business, protect investment, ensure future dividends, and provide more jobs through improved product and service. In simple, direct language, he explains the principles of management transformation and how to apply them.

Out of the Crisis

Objectives Patient safety has received increased attention in recent years, but mostly with a focus on the epidemiology of errors and adverse events, rather than on practices that reduce such events This project aimed to collect and critically review the existing evidence on practices relevant to improving patient safety Search strategy and selection criteria Patient safety practices were defined as those that reduce the risk of adverse events related to exposure to medical care across a range of diagnoses or conditions Potential patient safety practices were identified based on preliminary surveys of the literature and expert consultation This process resulted in the identification of 79 practices for review The practices focused primarily on hospitalized patients, but some involved nursing home or ambulatory patients Protocols specified the inclusion criteria for studies and the structure for evaluation of the evidence regarding each practice Pertinent studies were identified using various bibliographic databases (eg, MEDLINE, PsycINFO, ABI/INFORM, INSPEC), targeted searches of the Internet, and communication with relevant experts Data collection and analysis Included literature consisted of controlled observational studies, clinical trials and systematic reviews found in the peer-reviewed medical literature, relevant non-health care literature and "gray literature" For most practices, the project team required that the primary outcome consist of a clinical endpoint (ie, some measure of morbidity or mortality) or a surrogate outcome with a clear connection to patient morbidity or mortality This criterion was relaxed for some practices drawn from the non-health care literature The evidence supporting each practice was summarized using a prospectively determined format The project team then used a predefined consensus technique to rank the practices according to the strength of evidence presented in practice summaries A separate ranking was developed for research priorities Main results Practices with the strongest supporting evidence are generally clinical interventions that decrease the risks associated with hospitalization, critical care, or surgery Many patient safety practices drawn primarily from nonmedical fields (eg, use of simulators, bar coding, computerized physician order entry, crew resource management) deserve additional research to elucidate their value in the health care environment The following 11 practices were rated most highly in terms of strength of the evidence supporting more widespread implementation Appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk; Use of perioperative beta-blockers in appropriate patients to prevent perioperative morbidity and mortality; Use of maximum sterile barriers while placing central intravenous catheters to prevent infections; Appropriate use of antibiotic prophylaxis in surgical patients to prevent postoperative infections; Asking that patients recall and restate what they have been told during the informed consent process; Continuous aspiration of subglottic secretions (CASS) to prevent ventilator-associated pneumonia; Use of pressure relieving bedding materials to prevent pressure ulcers; Use of real-time ultrasound guidance during central line insertion to prevent complications; Patient self-management for warfarin (Coumadin) to achieve appropriate outpatient anticoagulation and prevent complications; Appropriate provision of nutrition, with a particular emphasis on early enteral nutrition in critically ill and surgical patients; and Use of antibiotic-impregnated central venous catheters to prevent catheter-related infections Conclusions An evidence-based approach can help identify practices that are likely to improve patient safety Such practices target a diverse array of safety problems Further research is needed to fill the substantial gaps in the evidentiary base, particularly with regard to the generalizability of patient safety practices heretofore tested only in limited settings and to promising practices drawn from industries outside of health care

Making health care safer: a critical analysis of patient safety practices.

Fueled by public incidents and growing evidence of deficiencies in care, concern over the quality and outcomes of care has increased in both the United Kingdom and the United States. Both countries have launched a number of initiatives to deal with these issues. These initiatives are unlikely to achieve their objectives without explicit consideration of the multilevel approach to change that includes the individual, group/team, organization, and larger environment/system level. Attention must be given to issues of leadership, culture, team development, and information technology at all levels. A number of contingent factors influence these efforts in both countries, which must each balance a number of tradeoffs between centralization and decentralization in efforts to sustain the impetus for quality improvement over time. The multilevel change framework and associated properties provide a framework for assessing progress along the journey.

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Improving the quality of health care in the United Kingdom and the United States: a framework for change.

A consistent finding in articles on quality improvement in health care is that change is difficult to achieve. According to the research literature, the majority of interventions are targeted at health care professionals. But success in achieving change may be influenced by factors other than those relating to individual professionals, and theories may help explain whether change is possible. This article argues for a more systematic use of theories in planning and evaluating quality-improvement interventions in clinical practice. It demonstrates how different theories can be used to generate testable hypotheses regarding factors that influence the implementation of change, and it shows how different theoretical assumptions lead to different quality-improvement strategies.

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Planning and studying improvement in patient care : The use of theoretical perspectives

Two of the current methodological barriers to implementation science efforts are the lack of agreement regarding constructs hypothesized to affect implementation success and identifiable measures of these constructs. In order to address these gaps, the main goals of this paper were to identify a multi-level framework that captures the predominant factors that impact implementation outcomes, conduct a systematic review of available measures assessing constructs subsumed within these primary factors, and determine the criterion validity of these measures in the search articles. We conducted a systematic literature review to identify articles reporting the use or development of measures designed to assess constructs that predict the implementation of evidence-based health innovations. Articles published through 12 August 2012 were identified through MEDLINE, CINAHL, PsycINFO and the journal Implementation Science. We then utilized a modified five-factor framework in order to code whether each measure contained items that assess constructs representing structural, organizational, provider, patient, and innovation level factors. Further, we coded the criterion validity of each measure within the search articles obtained. Our review identified 62 measures. Results indicate that organization, provider, and innovation-level constructs have the greatest number of measures available for use, whereas structural and patient-level constructs have the least. Additionally, relatively few measures demonstrated criterion validity, or reliable association with an implementation outcome (e.g., fidelity). In light of these findings, our discussion centers on strategies that researchers can utilize in order to identify, adapt, and improve extant measures for use in their own implementation research. In total, our literature review and resulting measures compendium increases the capacity of researchers to conceptualize and measure implementation-related constructs in their ongoing and future research.

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Measuring factors affecting implementation of health innovations: a systematic review of structural, organizational, provider, patient, and innovation level measures

Objectives.To assess the impact of total quality management (TQM) and organizational culture on a comprehensive set of endpoints of care for coronary artery bypass graft surgery (CABG) patients, including risk-adjusted adverse outcomes, clinical efficiency, patient satisfaction, functional health st

Assessing the Impact of Total Quality Management and Organizational Culture on Multiple Outcomes of Care for Coronary Artery Bypass Graft Surgery Patients

Background. Virtually all hospitals in the United States report that they engage in efforts to improve quality, such as continuous quality improvement (CQI). Little is known about the costs of these efforts and whether they are associated with improved outcomes or lower patient-care costs. Objectives. The principal objective of this study was to provide benchmark data on the costs of efforts to improve quality. The authors also attempted to determine if quality improvement expenditures are correlated with outcomes and/or condition-specific hospital costs. Methods. Detailed information on the cost of quality improvement was obtained from hospitals participating in a broad study of CQI activities. These data were correlated with patient outcomes and condition-specific costs. The subjects were medium to large hospitals throughout the United States. Senior managers provided budgetary information on direct costs of quality improvement, and details about meetings associated with quality improvement. They also provided summary medical bills for all patients undergoing total hip replacement and coronary artery bypass graft surgery. The billing information was combined with data provided by the Health Care Finance Administration to estimate condition-specific costs. Patients were directly surveyed to obtain information about satisfaction and outcomes. Results. There is a wide range of expenditures on quality improvement activities. Meeting costs are a substantial percentage of total costs. Neither total costs nor meeting costs are correlated with condition-specific costs. Discussion. Hospital managers can be expected to insist on evidence that quality improvement expenditures produce tangible benefits. This article provides benchmark estimates of those benefits and a methodology for further research.

Alfred W. Rademaker

Papers

Assessing the Impact of Total Quality Management and Organizational Culture on Multiple Outcomes of Care for Coronary Artery Bypass Graft Surgery Patients

The cost of efforts to improve quality.

Implementing Continuous Quality Improvement