PHYSICIANS AND QUALITY IMPROVEMENT IN HOSPITALS How Do You Involve Physicians in TQM? Brent C. James -- Intermountain Health Care, Inc. The recently created Malcolm Baldrige National Quality Award is a sign of the importance many American companies place on quality improvement as they struggle to succeed in an international marketplace. But competitive advantages gained through quality management are undermined by competitive setbacks in other areas, especially rising healthcare costs. More and more American manufacturers now cite healthcare costs as a major barrier to their ability to compete. For example, Chrysler Motor Corporation estimates that workers' healthcare benefits add more than $600 to the price of every American-made car. By contrast, Japanese cars are manufactured with less than $300 in healthcare overhead. Healthcare presently accounts for about 11 percent of the entire US gross national product. Expenditures in 1990 exceeded $600 billion. US healthcare costs are increasing at about 12 percent per year -- twice the rate of other parts of the American economy. It is not surprising that Dr. W. Edwards Deming singled out healthcare costs as one of three 'deadly diseases' sapping America's productivity and international viability. The American healthcare system is the focus of intense and increasing pressures to improve outcomes, curb costs, and increase value. The Forces of Change in Clinical Care The same forces that drove American manufacturing industries to quality-based management strategies -- competition, customer satisfaction, perceived value, and market share -- are now driving the American healthcare system toward similar approaches. Hospital-based, in-patient care represents an important subset of all healthcare expenditures. A growing number of hospitals have successfully adopted total quality management (TQM) strategies and, in specific cases, demonstrated quality improvements that resulted in significantly lower healthcare costs. The greatest challenge Most TQM projects within hospitals have so far, concentrated in areas where hospital management teams have the best control -- administrative and support services. But the main business of the American healthcare system is clinical care. Clinical care is jealously guarded as the sole province of healthcare professionals. Physicians must be involved, but how? This paper addresses a common question that hospital management teams have raised as they have restructured their organizations along quality lines: "How does one involve physicians in TQM efforts?" It first describes two different roles that independent physicians play within a hospital and relates those roles to a hospital's underlying business structure. It then lists a series of principles regarding physicians' behavior in each of the two roles. Finally, it argues that the critical issue surrounding physician involvement in TQM is ownership: whether independent physicians see quality management as a useful tool that will allow them to improve the care they deliver, or as a mechanism through which hospital management can control their actions. Health Professionals as Customers and Suppliers Medicine's business is the delivery of healthcare services to patients. Hospitals provide a setting for such care -- facilities, tools and support. But the services themselves are nearly always delivered by healthcare professionals -- nurses, physicians, and therapists. In a very real sense, healthcare professionals occupy a dual role. In many instances they are a facility's primary customers. In others, the facility and the healthcare professionals form a team charged with the care of patients. For example, a hospital's operations can be divided into three general categories: Support services These represent the 'hotel functions' that any service company must provide. Examples include admit/discharge, coordination and verification of payment sources, scheduling, billing, medical records management, and building maintenance. Support services are typically the exclusive province of administration. Healthcare professionals -- especially practicing patient-care physicians -- are very rarely directly involved in their operation. Physicians, however, use the services which support departments provide and have expectations regarding those services. For example: a physician may be concerned about whether a patient is in his/her room in time for an admitting examination; whether pre-admission laboratory tests are complete, accurate, and available in the patient's chart at the time of admission; and how medical charts are managed. With regard to support services, physicians function almost exclusively as customers. Medical infrastructure This includes those departments which provide medical support services to healthcare professionals directly involved with patient care. Examples include the blood bank, the clinical laboratory, physical therapy, respiratory therapy, radiology, and anesthesiology. Medical infrastructure departments are staffed by healthcare professionals but report to administration. Even in hospitals with independent medical staffs, physicians who oversee medical infrastructure departments are often on the hospital's payroll or have special contractual arrangements with the hospital. While some physicians in a hospital are service providers within medical infrastructure departments, most patient-care physicians are their customers: patient-care physicians use services that medical infrastructure departments provide. Clinical 'products' These are the diagnostic and treatment processes that hospitals provide to patients. For example, normal obstetrical delivery, medical treatment of acute myocardial infarction (heart attack), and surgical treatment of appendicitis are all clinical products. Patients are the primary customers for clinical products. For clinical products, patient-care physicians and other healthcare professionals function as a service provider team. Support services and medical infrastructure form the foundation upon which clinical products can be delivered. Nature of involvement changes with role -- As with any industry, healthcare professionals working within a hospital, whether independent or salaried, play multiple roles. In some settings they use the output of some other hospital department or function -- they are customers. In others, they provide services to patients or other healthcare professionals -- they are providers. The nature of a particular physician's involvement in a TQM project depends upon that physician's customer versus provider role with regard to that specific project. For example, patient-care physicians would probably show little interest in serving on a quality improvement team to improve the billing process, even though it may be very important to the hospital. With regard to the billing function, they see themselves as the hospital's customer. But patient-care physicians do show great interest in quality improvement projects for clinical products, when those projects are properly structured and introduced (see below). Principles for Physician Involvement Several principles should be kept in mind when planning ways to involve physicians in TQM efforts: Quality improvement is not new to clinicians. In the early 1900s, Dr. Ernest Codman applied Taylor's Scientific Management theory to American medicine. The resulting philosophy forms the basis of medical practice since that time: physicians commit to study the diagnostic process, the treatment process, and the outcomes of care for every patient, so that they can improve care for subsequent patients. As part of their training, physicians also study the scientific method, most receive a grounding in statistics, and all learn the necessity of objective over subjective data and analysis. When practicing clinicians first hear about quality improvement theory it is not unusual for a perceptive physician to comment: "This is nothing new -- it's just a rehash of what medicine has always taught!" While such an observation is correct in theory, it belies actual practice -- most clinicians fail to measure their treatments and outcomes objectively. They evaluate their 'experience' subjectively, as they remember each case. Further investigation reveals a systems failure that drives their behavior: even though they understand and are intellectually committed to quality improvement, they lack the training, the tools, the resources, and the time to routinely, objectively, track the diagnosis, treatment, and outcomes of every patient. Deming estimated that more than 85 percent of all workers in manufacturing were primarily motivated by their desire to do high quality work. Within healthcare the proportion is probably much higher -- most clinicians entered healthcare out of a sense of idealism and a genuine desire to serve. Repeatedly, physicians have demonstrated through their behavior that financial goals can be pursued only after high quality medical outcomes have been assured to the best of the practitioner's ability. Many physicians have a deep distrust of clinical measurement projects initiated by management. That distrust has a well- established basis in experience. For several decades healthcare quality assurance programs have used inspection to identify -- then punish -- 'bad' practitioners. Some clinicians also perceive that most management-sponsored 'quality' projects are in fact thinly disguised efforts to reduce healthcare resource utilization, seemingly without regard for the potential impact of such actions on patients' health. That is, they perceive that healthcare administrators want to take control of the process of care, limiting physicians' ability to adjust treatment to patients' needs, in order to reduce costs; while leaving physicians responsible for the bad outcomes that may result. A first step in a clinical TQM process is to drive out clinicians' reasonable fears. It requires both words and actions. For clinical products, physicians are already organized into quality teams. The medical profession requires that its members routinely evaluate and improve the quality of the medical care they deliver. In traditional medical practice, quality assurance takes place through 'peer review' -- a group of clinical peers, with fundamental knowledge regarding the disease and treatment in question, reviews a physician's performance, looking for mistakes or opportunities for improvement. Peer review is typically organized through sub-specialty medical staff groups and reports through an independent medical staff organization directly to the hospital's governing board. Within most hospitals, sub-specialty medical staff meetings are held on a weekly, biweekly, or monthly basis. Staff meetings bring together the core group of individuals responsible for a set of related clinical products. Independent physicians typically contribute their time and expertise to quality improvement efforts as part of their professional responsibilities. Sub-specialty staff meetings therefore provide an ideal setting in which to teach and apply quality improvement principles for clinical products. If the clinical team's nurses and therapists attend, the group can function as a semi- autonomous work team. Arguably, quality improvement techniques can also bring the practice of peer review closer to the vision espoused in an ideal medical practice. Rather than have a group of peers inspect each other's cases, physicians can jointly search for best practices by analyzing the care process and its outcomes across groups of patients. Independent physicians need to devote most of their time to their own practices. Most industrial TQM texts note that quality improvement training and team meetings should take place during normal working hours. If quality improvement activities are routinely held outside of working hours -- say, on evenings, weekends, or lunch hours -- then the workers will sense management's lack of full commitment, and the effort will probably fail. A similar principle applies in healthcare. Independent practitioners recognize their professional obligation to improve clinical care. Medical sub-specialty staff meetings and hospital quality committees are structured for that purpose. But most independent physicians are unwilling to devote significant amounts of additional time away from their own practices in order to meet a hospital's needs in the areas of support services or medical infrastructure, or to devote extra time to improve clinical products outside of their established commitments. Several options are available to accommodate the realities of independent practice: Structure clinical projects within existing medical staff meetings If activities beyond medical staff responsibilities are required, let salaried physicians use work time. Reimburse independent physicians, if only a token amount. Even though reimbursement usually cannot replace an independent physician's income from seeing patients for a similar period of time, it will acknowledge the physician's contribution and its importance to the organization. Respect physicians' time For example, if several physicians are asked to serve on a cross-functional team, but much of the team's work does not require their direct involvement, then plan the team's activities well enough to request their attendance only at critical points. Report to them in the meantime, so that they can keep abreast of the team's progress. Said another way, it is the organization's job to deal with the grunt work. Quality improvement forms a natural partnership between healthcare organizations and physicians. Physicians, nurses, and therapists have the fundamental knowledge necessary to stabilize and improve healthcare processes. They are ideally situated to lead quality improvement projects. Healthcare organizations can supply the other necessary ingredients: they can provide the data systems and personnel required to routinely measure healthcare processes and outcomes in a quality improvement setting. Clinical medicine is different from most industrial manufacturing processes. Even within industry it is not uncommon to see differences as continuous quality improvement principles are applied in different settings. The principles are the same, but the cultures and applications are different. The same is true in medicine. While unmodified industrial quality control has been successfully applied in the areas of support services and some aspects of medical infrastructure, clinical products can show differences. For example: Medical 'specifications' In industrial settings, it is usually possible to establish specifications for process operations and outcomes. But in clinical care many process operations have never been carefully established through clinical research. In such a setting, 'specification' often means the act of selecting an appropriate measurement point. Once a measurement point has been established, data feedback and peer review can be used to stabilize the process step across a clinical group. The stabilized process becomes the specification -- until an improvement project defines a better approach, with a better outcome. Medical 'variance' Within industrial settings, process capability is usually measured in terms of variance from a specification. For example, a hole with a specified diameter of one inch is to be drilled through a steel plate. Process capability measures the second statistical moment -- the variance in hole diameter from the specified one inch. Medical 'zero defects' Most clinical outcome goals, on the other hand, are stated in terms of quality absolutes -- zero percent failure rates or 100 percent success rates. In such a setting (as marginally noted within a number of statistical process control texts), process capability may be measured as the first statistical moment -- the mean failure or success rate, and its distance from the desired absolute goal. Patients show a very great degree of individual variability. The art of clinical medicine can be viewed as fitting a treatment to a particular patient's needs, rather than consistently applying the same treatment in all cases. Perception is everything Finally, most physicians do not perceive their work as a manufacturing process. They lack sufficient experience to see the theoretical similarities, and they reject any comparisons between the two undertakings. It is much easier to build on established medical practice, which already embodies the ideas of quality improvement, than to advance TQM as a whole new theory being imposed upon medical practice from industry. Ownership of Quality Improvement Projects In 1979, Williamson, et al., estimated that less than 20 percent of common medical process-of-care factors had any scientific basis established through clinical research. Since that time many other investigators have documented wide variation in physician practice patterns, both with regard to decisions to institute treatment and to the process of treatment itself. The degree of variation was found to relate directly to the amount of sound scientific information and professional consensus available within a particular area: the higher the information and consensus, the lower the variation. In very general terms, quality improvement is a two-step measurement process. The first step is to stabilize the process (eliminate assignable variation). Only after a stable environment is in place can the second step be attempted: to generate and scientifically test new ideas to improve the process and its outputs (document continuous improvement). The relationship between process stabilization and generation of scientifically valid knowledge leads to a Catch-22 conflict within the current American healthcare system. Until processes of care are stabilized, it will be very difficult to routinely generate the large amounts of valid clinical knowledge regarding day-to-day operational issues that the medical system requires. But until that knowledge is generated, it is extremely difficult to achieve the consensus necessary to stabilize processes of care. Stabilizing the process of care -- the first step in clinical quality improvement -- has been attempted in various ways. Different groups have tried several different approaches to bring physicians to a consistent process: Externally generated clinical care protocols or practice guidelines A number of national organizations have published 'clinical protocols' or 'critical paths' that define, to varying levels of detail, the specific steps in a standard process of care for a clinical product and the manner in which those steps should be performed. Lacking hard clinical data, such protocols are usually based upon expert consensus: a group of 'expert' clinicians meet and specify the desired process of care. Consensus protocols usually have little external validity among practicing physicians. Data to establish the superiority of a particular approach rarely exist -- if they did, the issue would have been decided on the basis of scientific fact, not consensus. Many physicians see consensus protocols as a means to limit their clinical freedom and wrest patient control from their hands. They honestly believe that, within their own practice area, they are as much of an expert as those who sat on the panel. Consensus protocols have therefore seen spotty acceptance. Their success seems to depend more on the process by which they are introduced to the clinical staff than upon their technical features. More recently, the American Medical Association, the American College of Physicians, and several sub-specialty medical societies have launched consensus groups. Such bodies work through established professional relationships and avoid many of the issues associated with management, government, or purchaser- sponsored groups. They therefore may be more successful in achieving general physician acceptance of national consensus guidelines. Care protocols generated by a small internal group Several large healthcare organizations have formed internal consensus panels for specific clinical products. Because such panels often involve only a small subset of physicians, and because they are sponsored by and operate through management, they suffer from many of the same difficulties experienced by external consensus panels. Practicing clinicians may fail to accept -- and simply ignore -- their recommendations. Care protocols generated by an entire practice group One way to achieve general acceptance of consensus guidelines is to invite every clinician involved with the clinical product to participate on the consensus panel. Several healthcare organizations have successfully used this technique with small groups of physicians. The problem, of course, is logistics: it is often difficult to bring many physicians together for extended working meetings. Process stabilization through data feedback -- As noted above, medical sub-specialty staff organizations often function as quality improvement teams. Physicians learn the fundamentals of quality improvement as part of their medical training. Some healthcare systems have used that training and professional structure to introduce formal quality management techniques within physician groups. The process involves several steps: 1. Establish patient eligibility criteria for entry to an on- going clinical study. Patients are selected who: a) are expected to receive the same treatment, except for random, patient based differences; and b) are expected to achieve the same outcomes, except for random, patient based differences. 2. If necessary, establish patient stratification variables to control known bias factors within the patient group (such as age, gender, et cetera). 3. Work with a clinical group to identify the most important process and outcome factors, even though specific performance specifications may not be known. 4. Collect the data elements identified in steps 2 and 3 on a series of patients. 5. Prepare comparative reports (subgroup across physicians) with an aim to document assignable variation among physicians. Statistical process control techniques work well for this purpose, although traditional bio-statistical analysis can also be used. 6. Blind the resulting data, to avoid the negative associations most physicians have regarding the 'bad apple' approaches that have traditionally been used within medicine. Identify each physician only to themselves. 7. Present the resulting data in a medical sub-specialty staff meeting. Raise the questions: "Why is there practice variation among comparable patients? What is the best treatment, given the several ways that members of the department practice?" The aim is to provoke a discussion among peers -- those who have fundamental knowledge about the process -- regarding best care. 8. Re-measure to document change, hold the gains, and continually improve the process. Experience indicates that, in most instances, physician-to- physician process variation will decrease and outcomes will improve. The physicians will lead the improvement process and own its results. Introducing physicians to quality improvement through non- clinical projects -- Practicing physicians are the customers of many other processes that occur in a healthcare organization. Several hospital groups have introduced physicians to formal quality improvement techniques through that relationship. They first ask physicians to identify the major problems they experience as they practice within the organization. They then work with physicians to prioritize the list. Then they launch quality improvement teams to solve the problems. Physicians were willing to actively participate on the team because they saw the potential for a personal gain. The physicians' personal experience with quality improvement made them more amenable to subsequent quality projects when they were introduced. Lessons Learned The main product of the American healthcare system is clinical care. Clinicians -- physicians, nurses, and therapists - - control that care. But most early efforts to apply total quality management techniques within the healthcare industry focused on problems within support services or medical infrastructure. In that setting, most clinicians see themselves as customers. They often do not perceive a personal role in assuring that patients routinely have positive experience regarding such matters. Early attempts to apply total quality management to clinical care processes rightly focused on process stabilization. Some groups, drawing upon the teachings of industrial quality control, tried to generate detailed specifications for healthcare process steps. They usually used care protocols developed by external consensus panels or through small internal groups. But independent physicians fear the loss of clinical control that such standardized protocols imply. They also distrust management's motives in introducing new control mechanisms. Therefore, the resulting protocols were often ignored. A basic principle of adult education is to first examine the students' state of understanding and to then proceed from that point. In fact, American medical traditions have taught the basic concepts of quality improvement for almost 80 years. Clinicians are already well-versed in fundamental quality improvement principles and committed to their use. But they lack the tools, resources, time, and technical expertise to routinely practice quality improvement, and they must overcome years of negative experiences under traditional 'bad apple' quality assurance programs. Three key factors to successful involvement -- In our experience, three factors should be considered as physicians are asked to participate on quality improvement teams: 1. Quality improvement theory should be presented as a direct extension of the principles that the medical profession has always espoused. Formal quality improvement is not a new idea -- it just brings a new set of tools that will allow physicians to better accomplish what they have always sought. For most physicians, quality improvement should not be described as 'industrial quality control.' Until they perceive the underlying quality theory, they will probably not understand the relationship between industrial manufacturing processes and the art of medicine. The 'industrial' comparison can be offensive to physicians and may lead them to reject the new TQM tools out of hand. 2. Quality leaders should consider physicians' self-perceived role as customers or providers as they plan physician involvement on quality improvement teams. Non-clinical projects must respect physicians' time. Clinical quality improvement projects can take advantage of the medical staff organization that is already in place. Clinical quality improvement within hospitals is a partnership: physicians and nurses supply fundamental knowledge and leadership; while hospital staff collect, analyze, and present data. It is the hospital's job to complete most team support tasks. 3. The first step in most clinical quality improvement projects is to stabilize the diagnostic and treatment process. But physicians control most major treatment steps. It is therefore critical that they are part of and own the process that is used to achieve stability. Several different approaches are available to achieve that end in different hospital cultures and clinical settings. In our experience, as these three factors are addressed and physicians recognize the relationship between total quality management principles and their profession, the problem quickly changes. It is not a question of how to involve physicians in a total quality management process, but of how to keep up with them as they move ahead. This article first appeared in a special Excellence in Healthcare issue of the Journal for Quality and Participation (Jan/Feb 1991): AQP 801-B W. 8th. St., Ste. 501, Cincinnati, Ohio 45203, Tel. 513-381-1959, Fax 513-381-0070. Call Sara Olberding at AQP Information Center for more articles and conference presentations on TQ in healthcare and other topics. Nominal fee for reprints.