An epidemiologic approach to quality improvement, quality assurance, and clinical research.
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With the enactment of the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88), the federal government is now using proficiency testing as the primary indicator of laboratory quality. Laboratories with proficiency test failures are now at risk of a variety of harsh penalties including large monetary fines and suspension of operations. To minimize the risk of failed proficiency testing, we initiated a continuous quality improvement program in our general chemistry laboratory in conjunction with the use of a new survey-validated quality control product. This article describes the quality improvement program and our success in reducing the long-term random error in general chemistry. Despite our improvement program, significant analytical errors (greater than 30% of the CLIA limits) still exist in analytes measured by our chemistry analyzer. These errors are present in nearly the same analytes measured by other common chemistry analyzers indicating the need for improvement in their design and manufacture.
This paper will review the reasons for the increasing emphasis on quality assurance in American healthcare and laboratory medicine. This emphasis is driven in part by economic, social and regulatory concerns as well as the traditional commitment to the search for excellence in services provided to patients. The Q-Probes Program of the College of American Pathologists (CAP) represents a response to these pressures and will be described in some detail. The program is based upon the historical success of interlaboratory comparison programs developed and sponsored by the CAP in achieving demonstrable improvement in laboratory performance. These programs are dependent on the gathering of data from large numbers of laboratories in order to establish provisional "benchmarks" of quality practice which serve as a baseline for systematic quality improvement efforts. The Q-Probes Program gathers peer-group specific institutional data concerning defined aspects of quality practice in pathology and laboratory medicine. These highly structured programs provide laboratories and pathology services with a format to collect data for submission to the CAP for analysis and to compare their performance against that of appropriately stratified peer groups. Several representative examples chosen from clinical laboratory medicine and pathology will be presented. We will attempt to demonstrate how individual laboratory and pathology services utilize aggregate data to effect specific changes in practice that lead to improvement in processes of patient care and better patient outcomes.
The federal government is currently supporting the development and dissemination of clinical practice guidelines. Physicians fear that payers who promote guidelines are more interested in reducing variation to control their behavior and contain health care spending than in improving quality of care. There is also apprehension that guidelines will shift the responsibility for quality to parties external to the physician-patient relationship and the local professional community. Continuous quality improvement (CQI) methods provide an avenue for physician responsibility and participation in guideline development which can alleviate these concerns. This article describes the efforts of one health maintenance organization (HMO) to use CQI techniques to mobilize plan physicians to develop, disseminate, and implement practice guidelines in a manner that satisfies the needs of physicians, patients, and the HMO.
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Continuous quality improvement is a concept which includes: Quality assurance--the provision of services that meet an appropriate standard. Problem resolution--including all departments involved in the issue at hand. Quality improvement--a continuous process involving all levels of the organization working together across departmental lines to produce better services for health care clients. Deming (1982b) and others have espoused total system reform to achieve quality improvement--not merely altering the current system, but radically changing it. It must be assumed that those who provide services at the staff level are acting in good faith and are not willfully failing to do what is correct (Berwick, 1991). Those who perform direct services are in an excellent position to identify the need for change in service delivery processes. Based on this premise, the staff nurse--who is at the heart of the system--is the best person to assess the status of health care services and to work toward improving the processes by which these services are provided to clients in the health care setting. The nurse manager must structure the work setting to facilitate the staff nurse's ability to undertake constructive action for improving care. The use of quality circles, quality councils, or quality improvement forums to facilitate the coordination of quality improvement efforts is an effective way to achieve success. The QA coordinator assists departments in documenting that the quality improvement efforts are effective across all departments of the organization, and aggregates data to demonstrate that they meet the requirements of external regulatory agencies, insurers, and professional standards. The nurse executive provides the vision and secures the necessary resources to ensure that the organization's quality improvement efforts are successful. By inspiring and empowering the staff in their efforts to improve the process by which health care is provided, nurse managers participate in reshaping the health care environment. The professional nurse plays a vital role in the quality improvement of health care services. However, nurses cannot make these improvements in a vacuum; they must include other professionals and ancillary personnel in their efforts. Total quality commitment must include all levels of an organization's structure. Quality patient care services will be achieved as the result of positive interactions among departments working together to build a dynamic mechanism that continuously improves the processes and outcomes of health care services.
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Quality improvement methodologies as applied to health care reflect a traditional practitioner-centered approach to defining and improving quality of services. However, health care must reconcile the values, needs, and preferences of providers with those of consumers if effective quality improvement programs are to be developed.
BACKGROUND: Continuous quality improvement is being advocated as the process that, if adopted, would improve the efficiency, productiveness, and quality of medical institutions, thereby helping to solve the health care crisis our country is facing. To determine if these techniques could be effective in a tertiary-care multispecialty group practice, a model project was undertaken. The model project chosen was to determine if we could improve the turnaround time for "stat" laboratory examinations performed in our large outpatient facility. METHODS: A 10-member team consisting of everyone involved in the process of laboratory testing was empowered to evaluate the present process and make appropriate changes. With traditional techniques of quality improvement, the process was assessed, data were collected and statistically analyzed, changes were introduced, and data were recollected and analyzed. RESULTS: After intervention, the preanalytic delays were reduced by 76% and the postanalytic delays by 88%. Waiting time for patients was reduced by an average of 62%. By instituting the changes suggested, the institution saved $225,000 on a one-time basis and $40,000 to $50,000 on a recurring basis. CONCLUSION: Adoption of quality improvement techniques appears to be a desirable management paradigm that should be explored by all medical institutions interested in maximizing the quality of care offered while at the same time minimizing its cost.
The pressure to improve the quality of clinical and customer service outcomes continues to escalate. In most cases, sustained improvement (either incremental or breakthrough) is a direct result of improving service delivery and work processes. The challenge, for managers, is to design work processes that predictably lead to satisfying and cost-effective results. Total quality management (TQM) and continuous quality improvement (CQI) may seem like "this year's fads," but they are form, not fashion. TQM and CQI processes generate a customer-responsive environment in which employees can contribute to achieving the organization's mission, vision, and strategic objectives.
Consumers are looking for better quality health care for their dollar. Nursing is challenged with providing excellent care in an age of shrinking resources. After years of chart audits and quality assurance, a new and broader focus is emerging. Continuous quality improvement is the latest theme in the ever-changing area of quality. It seeks to improve care through improving the processes used in delivering the care. A smooth transition from quality assurance to continuous quality improvement is possible through a complete understanding of both concepts, a willingness to work with others in the organization, and the ability to focus on process rather than on people.
Accelerated-compensation events (ACEs) are classes of avoidable medical injuries. Originally, these classes were used in tort reform to speed payment for avoidable injuries. However, ACEs also have potential as tools to monitor and improve the quality of health care. ACEs are developed by physicians, based on medical decision making. Rather than simply identify an adverse outcome, they link that outcome to clinical processes. Therefore, ACEs can help identify the critical elements of care that would result in desirable outcomes. Also, ACEs are discerning: they identify only events of which the vast majority are preventable. In one project, ACEs have been developed for obstetrics/gynecology, general surgery, and orthopedic surgery, using a three-phase process of sifting data and honing definitions. Future plans include improving these ACEs, statistically evaluating them, and testing them for utility in quality monitoring and improvement.
Whatever the educator's role in teaching quality methods, rapid, industry-wide changes in quality practices are having a profound impact on the education department. Familiar, comfortable teaching methods for monitoring and evaluation have disappeared. Clinical practice models, long the mainstay of nursing education, have become obsolete in today's multidisciplined environment. This article describes a new approach to quality improvement that utilizes a model expanded beyond clinical practice: a tri-focus of patient, staff, and system, integrated with the four broad-based categories of standards (structure, outcome, process, and evaluation) to achieve quality improvement within the organization.
Continuous quality improvement (CQI) and medical informatics specialists need to converge their efforts to create synergy for improving health care. Health care CQI needs medical informatics' expertise and technology to build the information systems needed to manage health care organizations according to quality improvement principles. Medical informatics needs CQI's philosophy and methods to build health care information systems that can evolve to meet the changing needs of clinicians and other stakeholders. This paper explores the philosophical basis for convergence of CQI and medical informatics efforts, and then examines a clinical computer workstation development project that is applying a combined approach.
Continuous Quality Improvement is in the process of being implemented in hospitals around the world. In an attempt to gain a better understanding of the "best management practices" the International Quality Study is being conducted in four countries--Canada, Germany, Japan and the United States--and across four industries--Health Care, Banking, Automotive and Computers. Information collected through a survey process will be analysed through causal modeling to determine correlations between management practices and achievement of quality objectives. Given both the complexity of the models and the number of key concepts involved, 400 hospitals have been invited to participate. The preliminary results show direct correlations between cultural influences and the concept of quality. The perceived definition of quality by the various countries varies and therefore the application of "quality concepts" differs. Once complete, this database of "best management practices" will serve as a worldwide benchmark for quality progress.
Continuous improvement of the quality of patient care is a major goal in state mental health systems, most of which operate several large hospitals and many community mental health centers geographically dispersed across the state. Although each facility may have an adequate quality assurance program, many opportunities for improvement are lost without integration of these efforts into a unified, statewide quality improvement system. The authors describe development of such a system in South Carolina and give examples of improvements in patient care that have taken place since the program was initiated in 1987. The activities of the central office of quality assurance include collecting and analyzing data about adverse incidents in state facilities, monitoring corrective actions, conducting annual surveys of operations at all state facilities, and investigating and coordinating resolution of complaints about patients' rights.
Surviving bone marrow transplant (BMT) represents a major victory against malignant disease but also creates challenges of survivorship for patients and the professionals who care for them. Part 2 of this report presents the findings of a qualitative study (N = 119) related to improving quality of life (QOL) for BMT survivors. Results are shared based on BMT survivors' perceptions of (a) what makes QOL better, (b) what makes QOL worse, and (c) what doctors or nurses could do to enhance QOL. The findings of the study have been useful in constructing a quantitative instrument to measure QOL in BMT and in understanding the conceptual basis of QOL for the BMT population. Nursing interventions can improve the QOL for the BMT patient across all phases of the transplant process and long-term issues related to survival.