Panel 4: Reporting Issues and Learning Approaches
Testimony of Roger M. Macklis, American Medical Group Association
The first National Summit on Medical Errors and Patient Safety Research was held on September 11, 2000, in Washington, DC. Sponsored by the Quality Interagency Coordination Task Force (QuIC), the Summitís goal was to review the information needs of individuals involved in reducing medical errors and improving patient safety. More importantly, the summit set a coordinated and usable research agenda for the future to answer these identified needs.
Individuals were selected by the Agency for Healthcare Research and Quality (AHRQ) to testify at the summit as members of the witness panels. Each submitted written statements for the record before the event, documenting key issues that they confront with regard to patient safety as well as questions to be researched. Other applicants were invited to submit written statements.
Disclaimer and Copyright Statements
At its Annual Meeting in March of this year, the membership of the American Medical Group Association (AMGA), approved the immediate implementation of its private sector initiative to effect a physician and patient driven simplification of the current health care system. AMGA is the national trade association representing over 300 of the largest and most prestigious physician practice groups in the United States, including the Mayo, Cleveland, Ochsner, Henry Ford, Lahey, Kaiser Permanente and Palo Alto Clinics. The physician members of AMGA provide primary and specialty care for 35 million patients across the country. The initiative, entitled "Simplifying the American Health Care System: Physicians Leading the WayPatients in Control," is based upon the premise that our health care system is in disarray, having lost its direction and concern for placing patient care as foremost and, in so doing, has digressed considerably from its original equitable tenets of access, quality and cost.
With its members, their patients and other pertinent private and public stakeholders, AMGA intends to implement an effort over the next four years that will simplify and reshape the American health care delivery system into a restored state that is patient-centered, readily accessible, medically safe, technologically current, administratively less burdensome, outcomes measurable, cost-efficient and cost-effective. Of these eight precepts, medical safety or the management of risk, is paramount in improving the quality and effectiveness of care and in reducing the associated costs of unnecessary errors and their sequelae. The approach to this maxim weighs heavily upon the establishment of a "culture of safety" which focuses upon improving trust, communications and shared accountability between the physician, peers and patients.
REGARDING MEDICAL SAFETYFOUR CORNERSTONES
Four cornerstones have been proposed for shoring up the precept of medical safety. These are: (i) multidisciplinary systems management, (ii) evidence-based practice guidelines, (iii) patient education and participation and (iv) voluntary, confidential reporting and assessment of adverse events. Multidisciplinary systems management brings to bear the full integration and utilization of the skills and expertise of all relevant members of a patient's health care team in the decision-making process and management of risk. In contrast to component or disease management, systems management advocates the consideration of both the illness and the wellness aspect of the patients' health spectrum in managing their overall care and safety.
The case for evidence-based practice guidelines has come to light in recent years as representative of the optimal translation of evidence-based research findings into tested and effective recommendations for providing and assessing various areas of clinical practice. While these guidelines serve as a road map to the most efficient and effective means of treating illnesses, they are not the only pathways that can be taken. In this regard, evidence-based practice guidelines help ensure medical safety by focusing upon appropriate and proven protocols of care whose credibilities are reassessed with each application of the practice prototype.
The importance of patient education and participation in fostering medical safety can not be understated. Today's patients are more curious and more determined in their quest for health information and have transformed themselves from reflex passivity to adamant assertiveness as their own health advocates. Thus, it behooves health care systems to assure them accurate channels of information to enable them to formulate intelligent dialogue and decisions with their health providers. In any case, the role of the patient in assuring medical safety is particularly germane away from the treatment facility.
The fourth cornerstone is embodied in the voluntary, confidential reporting and assessment of adverse medical events. Within a group practice, this base underscores the belief and professional sanctity of self-assessment and peer review by all members of a multidisciplinary team. From the first day of professional training, health providers are inculcated with a culture of self assessment and peer review for the end purposes of establishing medical knowledge, instilling professional competencies and fine-tuning quality care. Mediocre levels of quality care are not sanctioned in this culturation. Only the highest level of quality care characterized as wholly pertinent and clinically relevant is expected and accepted. Patients assess the quality of their care by observing the interpersonal skills, technical competence and patient support exhibited by their physicians. Deviations from medical safety result from failures in oversight or from lack of preventive safeguards in health care systems. These are epitomized as failures of an ordered process (such as disregarding key elements of an algorithm) or of an individual's own proficiency.
Thus, the emphasis in dealing correctly with adverse medical events must be placed on promoting problem solving, implementation of effective safety practices and prevention of recurrences. This encourages voluntary reporting whereas regulatory mandates promote codes of secrecy and silence because of fears of punitive retribution. It should be noted that this fourth cornerstone clearly sequesters itself from medically adverse acts that are intentional, abusive or grossly negligent. Such purposefully unsafe commissions of medical error should always remain within the purview of legal and regulatory authorities. Finally, reform of the existing malpractice litigation and the vindictive culture it promulgates will also contribute positively to voluntary appraisal, reporting and appropriate redress.
REGARDING REPORTING, LEARNING APPROACHES AND DATA REPOSITORIES
Two areas of discussion follow. The first is an example of how a large physician group practice is proactively engaging in establishing internal processes for identifying, preventing and reducing medical errors and promoting maximal potentials for patient safety. The second area deals with the ongoing development of AMGA's data warehouse that provides a repository of confidential and secured information between non-affiliated group practice members. The information contained reflects data regarding patient satisfaction, disease state management, utilization metrics, preventive and outcome measures as well as how this service will enhance its group members' issues on medical safety.
I. The Medical Safety Initiative at the Cleveland Clinic
The Cleveland Clinic is one of the larger medical group practices that are members of AMGA. The Clinic employs nearly a 1,000 physicians in essentially all areas of health care. Prior to the release of the IOM report on medical errors, the Clinic had internally discussed the need to develop a new infrastructure for patient safety data collection and medical practice improvement. The IOM report heightened the drive to follow through on these prior considerations.
Under the leadership of the Clinic's CEO, Dr. Robert Kay, and Dr. Roger Macklis, Chairman of the Department of Radiation Oncology, a program was established to reduce medical errors and promote medical safety across all clinical departments. The Clinic's underlying tenets are: (i) the problem of medical errors is a major health risk for both inpatients and for outpatients, (ii) many of these adverse events relate to systematic weaknesses in the way health care is delivered and (iii) it is incumbent upon major health care delivery systems to be proactive in minimizing patient risk and maximizing medical safety measures.
Dr. Macklis was given the responsibility of establishing a task force to coordinate the new "POEMs" (Prevention of Errors in Medicine) Initiative. The charge to the POEMs group was to evaluate the Institute of Medicine Report for trustworthiness and accuracy, analyze available information in relevant databases of the Clinic such as the legal files, ombudsmen reports and incident reports and formulate assessments, novel solutions and responses germane to the Clinic. Responses were expected to include efforts in staff education, bench-marking against "best practices" of other groups, changes in infrastructure, identification of error-prone processes and the development of new organizational and "technofix" strategies to minimize high risk events. Of note, the task force is a bona fide arm of the Cleveland Clinic Health Quality Institute and, as such, its work is regarded as a legally protected peer-review process.
A key element underlying the practical application of this approach to problem-seeking, preventing and solving was the belief that each specialty and practice group understands error-prone links in its own clinical work better than any administrative body. Therefore, a critical step for the Clinic task force was to ask each component within the Clinic to spend some time thinking and talking about medical errors encountered in that specialty's duties or about "near misses" experienced or heard about in its specialty. The end product expected of these segmented deliberations was a set of specialty-focused medical error reduction processes to be shared throughout the clinical units.
An example of such a specialty-specific response is the recent movement within orthopedic practices to have the surgeon of record, along with the patient, initial the joint intended for operation prior to the time the patient is put to sleep. This process was conceived as a way of reducing wrong-side surgeries, which are rare but nevertheless totally inexcusable. Cleveland Clinic determined it was possible for each of its clinical units to come up with similar specialty-targeted strategies to increase the level of medical safety through its health care system.
As part of this process, each department chairman was directed to discuss the issue and the project at all staff meetings and to encourage the solicitation of specific activities and procedures that represent potential error-prone processes germane to that department or specialty. These major sources of errors could include areas of technical implementation, judgment, trainee supervision, medication delivery or prescription and so forth. Though this process, topics considered to represent significant potentially frequent and potentially serious types of medical errors for that department group were identified, further examined and considered for correction by the department. The clinical services were also asked to consider some "near misses," how they might be managed and submit these for possible posting on the Internet under confidential files.
In less than 30 days, each department determined and ranked the top 2-3 specific error-prone processes which could occur within itself. An internal departmental working group then brainstormed on these issues, developed and returned appropriate interventions and strategies of mitigation to the Clinic's new Medical Safety Coordinating Office. The range of interventions contemplated covered the breadth of changes in infrastructure, techno-fixes, educational programs and so forth. As a result of this fast-track effort, 60 responses with over 100 medically adverse situations, real or possible, were submitted for the POEMs task force to review. That review process is currently being undertaken. It is expected that some of the proposed strategies or plans for redress may be operationalized without additional personnel or equipment. Other strategies may require a separate budget and additional funds. In any case, there is solid support among the Clinic staff for this endeavor to conduct a "preventive strike" to enhance medical safety.
II. American Medical Group Association's Data Warehouse
Systematic Reporting and Utility
In 1999, AMGA's Board of Directors considered the utility of a clinical and administrative data warehouse shared between large multi-specialty medical groups. This concept was novel in that no such facility had previously existed. The foremost benefit is that this composite of clinical and longitudinal data allows for the benchmarking of process and outcome measures across member groups. And as part of establishing a culture of medical safety, the information reported into this data warehouse becomes exceptionally valuable in designing and maintaining safety systems such as that previously mentioned about the Cleveland Clinic.
Over the past decade, AMGA has provided comparative data and networking support to medical groups to enhance the groups abilities to deliver high quality health care to their patients. Through the series of surveys and reports provided by AMGA, medical groups have been able to access data on comparative clinical information on patient outcomes, patient satisfaction, utilization statistics as well as key operating ratios and compensation. However, AMGA also realized its members needed access to operating performance information that differentiated peer performance and stimulated effective networking and sharing of best practices across non-affiliated member organizations. Although many large medical groups and integrated delivery systems currently have access to internal data marts or limited data warehouses, there currently is no national effort to collect and share critical information across non-affiliated medical group organizations.
The philosophic support for this warehouse service is based upon observations that health care organizations delivering health care services generally have low intellectual capital valuesas determined by the market. On the other hand, these same health care organizations can have high intellectual capital values if they standardize and continuously improve their services by systematically applying the health evaluation sciences to their work. Some consideration of intellectual capital bears mention at this juncture.
Intellectual capital has been previously defined as the sum of everything everybody in a company knows that gives it quality and a competitive edge. Intellectual capital, as an asset is intangible. It is the knowledge captured within the work force. The three types of intellectual capital are human, structural and customer focused. The knowledge, expertise and competence of an organization's employees represent human capital. Structural capital is based upon the existence or absence of databases, networks, documentation, guidelines, polices and procedures. Customer capital simply reflects a provider's relationship with patients and how provider and service qualities are assessed in the mind of the patient.
With the concept of intellectual capital established, the measurement or the fine tuning of this context is based upon the collection and utilization of information relevant to benchmarking performance, to establishing norms for process and outcomes measures and to practicing evidence-based medicine along with effective communications and corporate learning. In the case of AMGA's data warehouse, group practices are ideal settings for fostering progress in medical safety through the transfer of expanded medical knowledge between non-affiliated members. Group practices are natural laboratories for clinical and health services research, but need standardized data to describe patient care in geographically distinct locations. Also, group practices have much larger patient populations than traditional academic medical centers can muster. Lastly, group practices invest heavily in the continuing education of their practicing staff and base cost-effective and cost-efficient methods of care on retrospective studies of health care services.
Given these perspectives on group practices, the establishment and utilization of such a data warehouse increases the human, structural and customer intellectual capital of group practices through a number of avenues. Human capital is increased by systematic studies of operations seeking particular variations in practices that could be ameliorated to improve performance and by dissemination and sharing of insights of multi-disciplinary quality improvement in teams within an organization and between non-affiliated organizations. Structural capital is increased by standardizing information systems emphasizing practice policies and guidelines, by automating medical records to provide coded data and by building data warehouses for systematic analysis of observational and other data. Generating higher levels of enviable clinical results increases customer capital through medical safety issues that are certifiable for improved quality, better outcomes and cost-effectiveness.
With the aforementioned concepts in hand and being fully supportive of the creation of this data warehouse, AMGA's Board determined a number of ideals to ensure the professionalism, quality, security and fiscal obligations of the new data repository. To maintain the highest aspects of professionalism and quality, AMGA would partner with an academic health center noted and skilled in health services and clinical research to ensure a sophisticated, state of the art, analytical expertise to assess and evaluate the data collected. AMGA would also partner with a firm with established expertise in data warehouse development, clinical information management and communication, data analysis and predictive modeling. The firm would be responsible for establishing and maintaining the warehouse.
A brief mention is made here of the security of the data warehouse and its operational costs. Foremost on the security issue is that the clinical data warehouse must include an application service provider model for business to business communication of data over the Internet in a manner providing a shared, anonymous, de-identified database protected by robust encryption methods for additional privacy of the data. With regard to the fiscal outlays needed for this operation, the creation of this service for AMGA's member organizations would include the use of prudent business analyses and practices to create a base revenue that would offset the costs of the development of the warehouse, its products and services.
The advantages of this warehouse impacting the quality and safety of medical care are many. AMGA members will have access to comparative performance data from other similar group practices, allowing peer group comparison. Additionally, for the first time there will exist commercial decision support systems designed for the unique needs of multi-specialty group systems including systems for collecting clinical and claims data. (Decision support systems are the tools, programs and/or techniques used to transform raw data into usable and applied information, knowledge and wisdom.) Through the data warehouse, group members can participate on user groups and design teams to create a variety of reports and publications regarding best modes of established medical safety practices. Lastly, standardization of a data dictionary for the shared data warehouse will facilitate the implementation of best practices from one setting to another, minimizing confusion in communicating trends and behaviors in medical safety.
The databases making up the AMGA data warehouse are those items considered most pertinent to multi-specialty medical groups. These include:
- clinical reporting by type of patient and type of physician
- financial reporting by type of patient and type of physician
- disease state managementprocesses and outcomes by syndromes
- resource based relative value scales per physician
- utilization metrics by type of diagnosis, procedure and syndrome
- preventive measures
- outcome measures captured as functional, clinical and fiscal status of compensation and productivity of all physicians
- allied health worked compensation and productivity.
The utility of the warehoused information between AMGA members will avail them of a greater database, voluntarily created, by which the management of risk and the promotion of medical safety can be more fully considered and optimally realized because of their unique practice settings.
AMGA believes health care providers have the professional capacity and the ethical obligation to bear full responsibility for reporting events causing harm to patients. Through the enactment of transparent protocols instituting and maintaining parameters for assuring medical safety and quality care, health providers can render vigilant, consistent and accountable attention to medical and patient safety. These endeavors, of themselves, will contribute significantly to reducing medical errors and to enhancing the outcomes and associated costs of accessible and quality health care.
The current efforts at the Cleveland Clinic are representative of the initiatives being undertaken by AMGA's members within the unique context of medical group practices. The overall effectiveness of the approach described allows for clinical providers to self-examine the clinical and administrative processes within their own specialty or group, determine potentials for adverse effects upon patient care, make appropriate and expedient corrections as a preventive measure, enhance patient satisfaction and maintain the highest quality of patient care while containing unnecessary expenditures.
Lastly, AMGA's new data warehouse will provide a retrieval system and consistent base of information across which different physician group practices can share best practices and report other diverse factors which impact upon quality care and medical safety. This resource is particularly effective and efficient as a learning and implementing tool because the user medical groups also will be able to validate each other's findings as they improve upon their own.
Current as of September 2000
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