Adverse-event-reporting practices by US hospitals: results of a national survey.

CONTEXT: Little is known about hospitals' adverse-event-reporting systems, or how they use reported data to improve practices. This information is needed to assess effects of national patient-safety initiatives, including implementation of the Patient Safety and Quality Improvement Act of 2005 (PSQIA). This survey generated baseline information on the characteristics of hospital adverse-event-reporting systems and processes, for use in assessing progress in improvements to reporting. METHODS: The Adverse Event Reporting Survey, developed by Westat, was administered in September 2005 through January 2006, using a mixed-mode (mail/telephone) survey with a stratified random sample of 2050 non-federal US hospitals. Risk managers were the respondents. An 81% response rate was obtained, for a sample of 1652 completed surveys. RESULTS: Virtually all hospitals reported they have centralised adverse-event-reporting systems, although characteristics varied. Scores on four performance indexes suggest that only 32% of hospitals have established environments that support reporting, only 13% have broad staff involvement in reporting adverse events, and 20-21% fully distribute and consider summary reports on identified events. Because survey responses are self-reported by risk managers, these may be optimistic assessments of hospital performance. CONCLUSIONS: Survey findings document the current status of hospital adverse-event-reporting systems and point to needed improvements in reporting processes. PSQIA liability protections for hospitals reporting data to patient-safety organisations should also help stimulate improvements in hospitals' internal reporting processes. Other mechanisms that encourage hospitals to strengthen their reporting systems, for example, strong patient-safety programmes, also would be useful.

Quality and safety by design.

Rather than continuing to try to measure the width and depths of the quality chasm, a legitimate question is how does one actually begin to close the quality chasm? One way to think about the problem is as a design challenge rather than as a quality improvement challenge. It is time to move from reactive measurement to a more proactive use of proven design methods, and to involve a number of professions outside health care so that we can design out system failure and design in quality of care. Is it possible to actually design in quality and design out failure? A three level conceptual framework design would use the six quality aims laid out in Crossing the quality chasm. The first or core level of the framework would be designing for patient centered care, with safety as the second level. The third design attributes would be efficiency, effectiveness, timeliness, and equity. Design methods and approaches are available that can be used for the design of healthcare organizations and facilities, learning systems to train and maintain competency of health professionals, clinical systems, clinical work, and information technology systems. In order to bring about major improvements in quality and safety, these design methods can and should be used to redesign healthcare delivery systems.

Improving patient safety by instructional systems design.

Education and training are important elements in patient safety, both as a potential contributing factor to risks and hazards of healthcare associated injury or harm and as an intervention to be used in eliminating or preventing such harm. All too often we have relied on training as the only interventions for patient safety without examining other alternatives or realizing that, in some cases, the training systems themselves are part of the problem. One way to ensure safety by design is to apply established design principles to education and training. Instructional systems design (ISD) is a systematic method of development of education and training programs for improved learner performance. The ISD process involves five integrated steps: analysis, development, design, implementation, and evaluation (ADDIE). The application of ISD using the ADDIE approach can eliminate or prevent education and training from being a contributing factor of health associated injury or harm, and can also be effective in preventing injury or harm.

Using standardised patients in an objective structured clinical examination as a patient safety tool.

Standardised patients (SPs) are a powerful form of simulation that has now become commonplace in training and assessment in medical education throughout the world. Standardised patients are individuals, with or without actual disease, who have been trained to portray a medical case in a consistent manner. They are now the gold standard for measuring the competence of physicians and other health professionals, and the quality of their practice. A common way in which SPs are used in performance assessment has been as part of an objective structured clinical examination (OSCE). The use of an SP based OSCE can be a powerful tool in measuring continued competence in human reliability and skill performance where such skills are a critical attribute to maintaining patient safety. This article will describe how an OSCE could be used as a patient safety tool based on cases derived from actual events related to postdonation information in the blood collection process. The OSCE was developed as a competency examination for health history takers. Postdonation information events in the blood collection process account for the majority of errors reported to the US Food and Drug Administration. SP based assessment is an important patient safety tool that could be applied to a variety of patient safety settings and situations, and should be considered an important weapon in the war on medical error and patient harm.

Organizing patient safety research to identify risks and hazards.

Patient safety has become an international priority with major research programmes being carried out in the USA, UK, and elsewhere. The challenge is how to organize research efforts that will produce the greatest yield in making health care safer for patients. Patient safety research initiatives can be considered in three different stages: (1) identification of the risks and hazards; (2) design, implementation, and evaluation of patient safety practices; and (3) maintaining vigilance to ensure that a safe environment continues and patient safety cultures remain in place. Clearly, different research methods and approaches are needed at each of the different stages of the continuum. A number of research approaches can be used at stage 1 to identify risks and hazards including the use of medical records and administrative record review, event reporting, direct observation, process mapping, focus groups, probabilistic risk assessment, and safety culture assessment. No single method can be universally applied to identify risks and hazards in patient safety. Rather, multiple approaches using combinations of these methods should be used to increase identification of risks and hazards of health care associated injury or harm to patients.

A system of analyzing medical errors to improve GME curricula and programs.

The report of the Institute of Medicine (IOM) To Err is Human recommended that both mandatory and voluntary event-reporting systems be established to identify and learn from errors. Because of the tight coupling of graduate medical education (GME) programs and the delivery of care, any event-reporting system used in a teaching hospital should be able to document the types of errors that are being made by graduate medical trainees (GTs). The authors performed an analysis of the root causes of events involving GTs that were recorded in hospital-based near-miss reporting systems. The root causes were classified using the Eindhoven Classification Model, medical version. Case histories of three separate events, one from an accident and emergency department in the United Kingdom, and two from a large teaching hospital in the United States, are used to illustrate the method. In all three cases, lack of knowledge on the part of the trainee contributed to the incident. Inadequate educational preparation had the potential for causing significant harm to the patient. Organizational causes were also present in each case, which illustrates the need to examine not only educational issues but also procedural and management issues related to GME. In each case, the analysis revealed in striking clarity deficiencies of educational content and problems of program structure. The authors conclude that doing a root-cause analysis in conjunction with a near-miss event-reporting system in a teaching hospital can be a valuable source of documented information to guide needed educational and system changes to GME programs.

Measuring and predicting academic generalists' work satisfaction: implications for retaining faculty.

PURPOSE: To develop a measure that could be used to identify interventions to improve the work satisfaction of academic generalists. METHODS: To field-test the measure, the authors surveyed the generalist faculty at the University of Texas Southwestern Medical Center at Dallas. Ninety-four (80%) of the faculty responded. The measure's reliability was established using Cronbach's alpha, and its validity was established with the Pearson correlation coefficient using a previously validated global work-satisfaction measure. Using ten work-satisfaction dimensions and selected faculty characteristics, the authors performed univariate and stepwise multiple regression analyses to predict the generalist faculty's global work satisfaction and intentions of leaving their positions. RESULTS: Work-satisfaction dimension predictors were autonomy in the workplace, professional status, teaching activities, clinical resources and activities, professional relationships, institutional governance, compensation, and professional advancement. Faculty characteristic predictors were gender, age, race or ethnicity, and living with children. CONCLUSION: The measure includes eight valid and reliable work-satisfaction dimensions that predict global work satisfaction or intentions to leave. Others may want to use this measure, along with the four faculty-characteristic predictors, as a management tool for improving academic generalists' work satisfaction and, ultimately, their performances and retention.

Using antecedents of medical care to develop valid quality of care measures.

OBJECTIVE: To present a new model for using the antecedents of medical care in outcomes assessment to develop valid quality of care measures. METHODS: The pertinent literature describing the history of outcomes assessment and the influence of patient and environmental risk factors on health status were reviewed. RESULTS: Past outcomes assessment studies have not consistently demonstrated a correlation between the processes and the outcomes of care. The use of the model described in this article indicates that the lack of correlation between process and outcome is probably because past outcomes assessment studies lacked the inclusion of medical care antecedents (primarily patient and environmental risk factors) that had a significant influence on the outcomes measured. Included is a description of a study that tests the utility of incorporating the antecedents of medical care into outcomes assessment to develop valid quality of care measures. CONCLUSION: The model presented in this article advances quality of care measure development by using: (i) qualitative research to characterize the pertinent antecedents of medical care; and (ii) as many of the pertinent antecedents of medical care as possible to develop risk adjustment models for measuring outcomes that are more likely to identify the true linkages between the processes and outcomes of care. Knowing the linkages between the processes and outcomes of care would provide the information needed to develop valid quality of care measures, so that quality can be measured accurately and the groundwork for its improvement can be laid.

Identification and classification of the causes of events in transfusion medicine.

BACKGROUND: Transfusion medicine lacks a standard method for the systematic collection and analysis of event reports. Review of event reports from the Food and Drug Administration (FDA) showed a relative paucity of information on event causation. Thus, a causal analysis method was developed as part of a prototype Medical Event Reporting System for Transfusion Medicine (MERS-TM). STUDY DESIGN AND METHODS: MERS-TM functions within existing quality assurance systems and utilizes descriptive coding and causal classification schemes. The descriptive classification system, based upon current FDA coding, was modified to meet participant needs. The Eindhoven Classification Model (Medical Version) was adopted for causal classification and analysis. Inter-rater reliability for the MERS-TM and among participating organizations was performed with the development group in the United States and with a safety science research group in the Netherlands. The MERS-TM was then tested with events reported by participants. RESULTS: Data from 503 event reports from two blood centers and two transfusion services are discussed. The data showed multiple causes for events and more latent causes than previously recognized. The distribution of causes was remarkably similar to that in an industrial setting outside of medicine that uses the same classification approach. There was a high degree of inter-rater reliability when the same events were analyzed by quality assurance personnel in different participating organizations. These personnel found the method practical and useful for providing new insights into conditions producing undesired events. CONCLUSION: A generally applicable and reliable method for identifying and quantifying problems that exist throughout transfusion medicine will be a valuable addition to event reporting activity. By using a common taxonomy, participants can compare their experience with that of others. If proven as readily implementable and useful as shown in initial studies, MERS-TM is a potential standard for transfusion medicine.

The attributes of medical event-reporting systems: experience with a prototype medical event-reporting system for transfusion medicine.

OBJECTIVE: To design, develop, and implement a prototype medical event-reporting system for use in transfusion medicine to improve transfusion safety by studying incidents and errors. METHODS: The IDEALS concept of design was used to identify specifications for the event-reporting system, and a Delphi and subsequent nominal group technique meetings were used to reach consensus on the development of the system. An interdisciplinary panel of experts from aviation safety, nuclear power, cognitive psychology, artificial intelligence, and education and representatives of major transfusion medicine organizations participated in the development process. Setting.- Three blood centers and three hospital transfusion services implemented the reporting system. RESULTS: A working prototype event-reporting system was recommended and implemented. The system has seven components: detection, selection, description, classification, computation, interpretation, and local evaluation. Its unique features include no-fault reporting initiated by the individual discovering the event, who submits a report that is investigated by local quality assurance personnel and forwarded to a nonregulatory central system for computation and interpretation. CONCLUSIONS: An event-reporting system incorporated into present quality assurance and risk management efforts can help organizations address system structural and procedural weakness where the potential for errors can adversely affect health care outcomes. Input from the end users of the system as well as from external experts should enable this reporting system to serve as a useful model for others who may develop event-reporting systems in other medical domains.

Verifying the curriculum of a family medicine clerkship.

The learning experience during a medical school clinical rotation is largely shaped by students' patient encounters. This paper reports on how a log system for recording these encounters can be used for course planning and evaluation. Over the past 5 years, 960 third-year students completed log forms based on their clinical encounters during a required 4-week family medicine clerkship at UT Southwestern. These forms were then optically scanned and the information entered into a computerized database. Log form data revealed that the most common medical problems encountered by students in their ambulatory settings were similar to those reported in the general family practice literature. There was a great deal of consistency in the types of encounters from year to year. The data also showed some differences among clerkship sites in terms of patient demographics and the most frequently reported diagnoses. Information generated from student log forms has been used by the clerkship faculty to determine required readings, prioritize didactic topics and other teaching, adjust curriculum content, prepare support materials and develop examinations. Given the utility of the information obtained and the ease of use of optical mark encounter sheets, we recommend this system for other clerkships.

Developing strategic plans for academic general internal medicine.

There is an increasing need to train more primary care physicians. Therefore, it would be advantageous for academic general internal medicine (GIM) to develop strategies to meet these demands. Our GIM division developed a strategic planning process with the participant groups being the division faculty, a pertinent literature review (the surrogate expert), and selected medical administrators. The IDEALS systems design provided the conceptual framework for the strategic planning process. This process used the Delphi technique to develop the theoretically ideal work system based on the division's vision for its future role, and the Nominal Group Process Technique to create the recommended work system, using the Delphi results. The strategic planning process was economical and division faculty agreed that it was useful.

Analyzing and adjusting for variables in a large-scale standardized-patient examination.

BACKGROUND: Structuring a clinical performance examination that uses standardized patients (SPs) for large groups of examinees often involves the use of two or more parallel forms of the examination with different SPs portraying the same case on the different forms. In addition, each form may be administered more than once on different days and/or in different locations. METHOD: To determine the effects of critical variables, such as day of examination, time of day (AM/PM), which of two simultaneous forms were taken, and sequencing effects, a univariate nested factorial analysis of variance was conducted for each of four annual SP examinations (1990-1993) at the University of Texas Southwestern Medical School. The examinations were given to approximately 200 second-year students per year at the end of their Introduction to Clinical Medicine course, and were graded on a pass/fail basis. RESULTS: Statistically significant differences were found for the following variables: (1) time of day (AM or PM) and day were significant but were inconsistent and of small magnitude; (2) sequencing for the first two stations was significant in each form of the examination and in all four years; and (3) form-within-case differences (i.e., differences between SPs) were significant between the two forms of the examination in each year of administration. To minimize the impacts of these variables, two mean equating formulas were applied to the scores. Few examinees' pass/fail status would have been affected by either adjustment. CONCLUSION: The parallel-forms examination format is minimally affected by the variables evaluated and is a fair pass/fail assessment of a student's performance. Mean equating is a valuable tool in minimizing the possibly unfair impact of variables on pass/fail decisions for homogeneous student populations.

Developing a support system for teaching and assessing clinical competence.

Primary care medical school faculty, in partnership with the faculty and staff of a Department of Biomedical Communications (Office of Medical Education) developed a teaching and logistical support system using standardized patients. The patients are used to teach history and physical examination skills to students in an introductory clinical medicine course. Having both clinical assessment team members, who are skilled biomedical communicators, and designated clinic rooms for standardized patients provides the foundation necessary for this growing area in medical education. Improved student performance, as measured by an Objective Structured Clinical Examination (OSCE), and students' positive ratings and comments in the evaluation of the course demonstrated the efficacy of using standardized patients in teaching and assessing clinical performance.

The FLEXTRA kit: a model for instructor support materials.

The FLEXTRA Kit is a model for the development of resource materials to support instructor-delivered continuing education. Each FLEXTRA Kit consists of camera-ready copy of handout materials; presentation slides, overheads, videotapes, etc.; evaluation instruments; and an instructor's guide. The FLEXTRA Kit is packaged in such a way that it can be easily shipped and stored. Desktop publishing makes the production of FLEXTRA Kits a cost-effective means of providing support to repeated and locally variable training events.

The health sciences communicator as faculty developer.

To determine the content for a model faculty development program for primary care faculty, a combination of the Delphi and Nominal Group Technique was used resulting in a curriculum with five units of instruction: development of curriculum and instruction, teaching methods, evaluation, administration, and academic survival skills. A philosophy for conducting faculty development is presented which includes concepts of andragogy, technology transfer, the diffusion of innovation, and networking. Program types include short-term, long-term, and extended programs such as fellowships.

Determining the core competencies of the ideal health sciences communicator.

The Education Committee of HeSCA conducted a Delphi study to generate agreement among a panel of experts regarding the core competencies of an ideal health sciences communicator. Seventy-five present and future competencies were identified and classified in terms of relative importance. Competencies concerning general communications techniques were determined to be most important, followed by abilities specifically related to the health sciences communications field. Management competencies were third in order of importance, and competencies that dealt with having a knowledge of the health sciences ranked fourth. The information reported helps to describe the knowledge and skill basis of the profession, as perceived by leaders in the field. The results can serve as guidelines for planning continuing education programs and professional development activities for health sciences communicators.

Visual abstracting as a decision-making tool in the selection of mediated material.

Visual Abstracts are abbreviated versions of complete instructional packages, designed to serve as decision-making tools for instructors to evaluate whether or not the complete package will meet desired instructional needs. This article describes development of four prototype visual abstracts and a pilot field test. The pilot field testing indicated that all four prototype visual abstracts were effective decision-making tools. Further research is clearly indicated to more fully document the effectiveness of visual abstracts.