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Because the science of health care is changing so fast, health care organizations — health plans; hospitals, nursing homes and other health care facilities; and health care practitioners — need to match that pace of change. While quality health care depends heavily on the building of strong relationships between patients and those who care for them, the systems of care that surround those relationships are becoming increasingly complex and difficult to manage. Health care organizations must be willing to learn from other industries that have demonstrated success in making complex systems function better in order to improve quality. While numerous health care organizations already have begun to tackle this task and provide good role models for others, much remains to be done. Implementing the recommendations below will require significant cultural change in the leadership, professional participation, and daily work of most of today's health care organizations.
Health care organizations should provide strong leadership to confront quality challenges. Organizations should develop a culture that is supportive of leadership, innovation, and risk taking. They should strive to attract, reward, and retain strong leaders while providing mentoring opportunities for new generations of leaders. Educational institutions should build organizational leadership into their curriculum. Professional associations and labor unions should establish aims for improvement of their professions and make quality improvement an integral part of their agendas.
Organizations should establish and pursue aims for improvement. Organizations should be supportive of national efforts to establish aims for improvement and provide local leadership in their communities to achieve those aims (see Chapter 3).
Organizations should become skilled at using and learning from quantitative information to measure progress toward quality improvement. The key goal should be to improve the performance of systems of care as a whole rather than improving parts of the system at the expense of the whole. There should be a commitment to evidence-based health care with processes put in place to systematically reevaluate established practices.
Organizations should commit themselves to continuous improvement and the elimination of waste. Health care organizations should recognize that most quality problems are due to faulty processes not individuals' failings. A clear link should be established between quality improvement and the elimination of wasteful processes.
Organizations should make a commitment to reducing error and increasing safety. The health care industry should examine the possibility of establishing a national system for reporting and tracking errors. Changes in medical malpractice, tort and quality oversight systems are also needed to create a climate in which errors can be more readily reported, analyzed and prevented, while still providing fair and equitable compensation to victims of error (see Chapter 10).
Organizations should build long-term relationships with all stakeholders. Contracts with suppliers and other vendors should build quality improvement into long-term planning.
Organizations should commit themselves to fundamental change in their work environment, involving and empowering all employees. Employees should feel free to report errors and instances of improper care, as well as suggest innovations, regardless of their position within an organization.
The literature on quality improvement, both inside and outside of health care, is unanimous in highlighting the important role of leadership in improving quality. Only strong leadership can build an organizational culture supportive of change, establish aims for improvement, and mobilize resources to meet those aims.
Organizational culture--the values, beliefs and norms of an organization that shape its behavior-- is a key variable affecting the capacity of any organization to improve its performance. Because improvement requires change, organizations that support innovation and risk taking are more likely to be able to undertake successful quality improvement efforts (Shortell et. al., 1995; Carman et. al., 1996).
While organizational culture is clearly an important factor in quality improvement, it is not necessarily easy to change. The organizational culture of a hospital, nursing home or other organization is built up over years and is the product of decisions by a large number of actors. An organization that realizes the need to develop a strategy for quality improvement, but whose organizational culture is not supportive of innovation and risk taking, faces a difficult dilemma. In such a situation, only active and visible support from clinical and managerial leadership for the continuous improvement of quality of care and service is likely to bring about successful change (Laffel and Blumenthal, 1989).
One of the important tasks of leaders is to establish specific aims for improvement. No organization, however committed, can improve all areas of its performance simultaneously. So many possible agendas are possible for an organization that improvement efforts can easily become chaotic unless a leader can rally effort around a few specific purposes.
At least some of the aims that an organization establishes should be highly ambitious. "Stretch goals," as they are often termed in other industries, make it immediately obvious that the current system is inadequate and that a new one is required. A less ambitious goal creates the temptation to simply stress the system to achieve marginal gains, gains that will probably be unsustainable over the long run. Not all of an organization's aims for improvement need to be stretch goals, but some such goals should be a critical element of the aim-setting process (Berwick, 1996).
Chapter 3 discusses the need for a national set of aims for improvement. One of the important tasks facing health care leaders is to translate these national aims into specific aims for their organization.
The capability of health care systems to measure their own achievements, a precondition to improvement, requires the ability to see care through the eyes of the patient. At a more technical level, research suggests that the measurement of functional status, pain, emotional well-being, social and role functioning, and target symptom status is best done by asking patients themselves (Greenfield et. al., 1985).
One example of a renewed focus on customer satisfaction in health care is increasing attention to waiting times as a key area for improvement. Long waits for appointments and tests frustrate patients and can lead to quality problems if patients are unable to see a physician or must endure long waits for test results. In 1996, the Institute for Healthcare Improvement in Boston assembled 27 health care organizations in a "Waits and Delays" project. The group met three times over 12 months to learn classic quality management principles, and industrial design concepts. Participants also stayed in touch between meetings to swap ideas. The group's work has led to a dramatic turnaround in some cases. In just three months, a Catholic hospital in Illinois cut triage time in the ER from 45 minutes to no more than 15 (Nordhaus-Bike, 1997).
Customer focus is also leading health care organizations to redesign patient satisfaction surveys so that they can provide real guidance for improvement efforts. In 1991, the Henry Ford Health System began surveying internal and external customers regarding the barriers they experienced in accessing care. This data was used to guide the work of process improvement teams, which tried to address the identified barriers. One team, for example, focused on the availability of telephone triage and nursing-advice services and recommended upgrading phone systems and developing consistent advice guidelines (Antcil and Winters, 1996).
Leaders of health care organizations seeking quality improvement face a unique set of challenges. In industrial settings, top management assumes responsibility for demonstrating leadership for quality. Many health care organizations, however, possess a more diffuse leadership structure due to the presence of an organized body of professionals who are not employees and a broader set of stakeholder relationships due to public or tax-exempt status (Weiner et. al., 1997).
One of the most important tasks that leaders of health care organizations must undertake is the involvement of clinical staff in quality improvement efforts. Such involvement is critical if these efforts are to be successful. Past research has suggested that hospital leaders often intentionally narrow the focus of QI efforts to business or service processes to avoid the appearance of management encroachment on physician autonomy in clinical decisionmaking. There is also evidence that physicians are often reluctant to participate in QI projects due to distrust of hospital motives, lack of time and fear that reducing variation in clinical processes will compromise their ability to vary care to meet individual patients' needs (Weiner et. al., 1997).
One way of encouraging the involvement of clinicians in quality improvement efforts is to introduce the techniques of continuous improvement into their educational experience. A particularly interesting initiative in this area, is the Community-Based Quality Improvement Education for the Health Professions (CBQIE-HP), a joint project of the Bureau of Health Professions/Health Resources and Services Administration and the Institute for Healthcare Improvement. CBQIE-HP will involve both students and practicing health professionals at ten demonstration sites across the country. At each site, an interdisciplinary team will identify an aim for improvement in a specific area of health care and take action to achieve that aim (Bureau of Health Professions, 1997)
A health care organization dedicated to continuous improvement must become, almost by definition a learning organization. A learning organization is an organization "skilled at creating, acquiring, and transferring knowledge and at modifying its behavior to reflect new knowledge and insights" (Garvin, 1993). While a great deal of learning already goes on in health care organizations, much of this learning is aimed at improving individuals — physicians learning to become better physicians, nurses learning to become better nurses — rather than learning how the system as a whole can improve.
An organization seeking to improve must have an understanding of systems. Russell Ackoff, an exponent of modern systems theory, defines a system as "a set of interdependent parts sharing a common purpose" in which the behavior of each element of a system has an effect on the behavior of the whole (Ackoff, 1981). Health care organizations — health plans, hospitals, clinics, physician offices — all display the characteristics of systems.
A key element of a system is that its performance depends as much on how its parts interact as on how they act independently of each other. Ackoff gives the example of a group of engineers who endeavor to build the best automobile by identifying which manufacturer makes the best engine, carburetor, brakes, and so on, and then putting these various parts together. Not only would such a car be unlikely to work well, it would probably not even run at all (Ackoff, 1981).
Berwick (1995) notes that this kind of "suboptimization" — parts being improved without cognizance, and perhaps even at the expense, of the performance of the system as whole — is quite common in health care. He cites a typical example of a clinical assistant in a pediatrics department who keeps a stack of tuberculosis test cards hidden away to prevent staff from the internal medicine department from "stealing" them. Such an approach, while benefitting the staff in the pediatrics department and solving their immediate problem, clearly can harm the operation of other departments and does not address the underlying problem of why the cards run out in the first place.
The challenge for health care organizations is to move beyond suboptimization to systemic improvement. In addition to understanding how systems operate, they must diffuse this understanding throughout their organization. They must bring people together across the boundaries of profession, job classification, and department so that everyone understands how their "part" interacts with the "whole."
There is an old saying that "what gets measured, gets done." In order to learn how to do things better, an organization must know how it is currently performing. One advantage that health care organizations possess is that they already generate an enormous amount of data in the course of their everyday work. In many cases, however, this data has never been used to guide quality improvement efforts. Data collection efforts often need to be modified to focus on new problems that are being addressed. Existing information systems are often inadequate to guide internal quality improvement efforts (see Chapter 14).
One of the objectives of measurement is to identify, analyze and control unintended variation in the delivery of health care services. The recognition and analysis of variation are fundamental to modern industrial thinking about quality measurement. All aspects of medical care display variation. Laffel and Blumenthal (1989) cite the example of a set of patients with sepsis, who will vary in the strength of their infection and its responsiveness to antibiotic treatment, as well as in their underlying conditions that may affect the course of treatment. The particular mix of physicians, nurses and support personnel also varies, as does the availability of diagnostic tests and the accuracy with which they are performed.
Clearly, there are many sources of variation that should not be controlled. It is often necessary to develop treatment plans that are customized to meet the needs and expectations of individual patients. Nevertheless, many quality experts believe that substantial quality improvement can be achieved by eliminating unnecessary variation in the execution of the processes by which these treatment plans are implemented. In the case of a set of patients with sepsis, Laffel and Blumenthal (1989) note that quality could be improved if technicians use the same techniques and equipment for obtaining, handling and interpreting blood cultures and if nurses use the same techniques and equipment for measuring patients' temperature and applying wound dressings. If physicians choose to follow similar procedures for determining the source of infection and for selecting and modifying antibiotic coverage, it is likely that the hospital would be able to implement their care plans more efficiently and accurately.
One of the objectives of a health care organization committed to learning should be to improve the match between scientific knowledge and clinical practice. On the one hand, there is evidence that patients obtain a significant amount of inappropriate care (i.e., treatment that is not scientifically justified). The RAND Health Services Utilization study found that 17 percent of coronary angiographies, 32 percent of carotid endarterectomies, and 17 percent of upper gastrointestinal endoscopies were performed inappropriately in 1981 in a large sample of Medicare beneficiaries (Chassin, 1997). On the other hand, there is also evidence that many patients who could benefit from a particular course of treatment do not receive it. This problem exists in both managed care plans and traditional fee for service plans. One recent study found that 41 percent of hypertensive patients in fee-for-service plans had their blood pressure controlled, compared to 54 percent in managed care plans (Udvarhelyi, et. al., 1991).
Health care organizations seeking to bridge the gap between research and practice must create a climate that "enables and motivates innovation," including providing resources for innovation, promoting frequent communication across departmental lines, developing mechanisms for focusing attention on changing conditions, and creating structures that provide access to innovation role models and mentors (Van de Ven, 1993). This last element may be particularly important in the context of health care, where consultation with colleagues is a key avenue for the spread of medical innovations (Felch and Scanlon, 1997).
An important element of a learning organization is the ability to engage in small-scale experiments of new ideas. Walter Shewart, one of the important theorists of industrial quality control, noted the importance of making the process of scientific prediction part of the daily work of an organization. He called it the "plan-do-check-act" (PDCA) cycle, which is simply a process for systematically testing new ideas, evaluating their results, and then implementing them if they are successful (Shewart, 1980).
A number of health care organizations have used this kind of experimentation to test new approaches to care. A team at Park Nicollet Hospital in Minneapolis-St. Paul used the PDCA cycle to improve the process of evaluating possibly cancerous breast masses. The team developed a new procedure — using a machine that allowed the radiologist to place a needle and do a breast mass biopsy in a single session — and then tested it by submitting 100 women to both the old and new procedures to compare detection rates. Finding no difference, the team implemented the new process, which reduced the time period between first evaluation and definitive diagnosis from several weeks to two or three days (Blumenthal and Edwards, 1995).
Not all change is improvement, but all improvement requires change. Once aims have been established and information has been gathered and evaluated, organizations must take action. They must commit to continually improving their processes of care, reducing error and eliminating waste. They must be willing to overcome barriers between disciplines, departments, and organizations. And they must empower their own employees to make change.
One of the fundamental insights of quality improvement theorists is that processes, not individuals, should be the primary objects of quality improvement. While this idea has gained greater currency in recent years, a significant share of quality assurance efforts in the health care industry are still being driven by what Berwick (1989) calls the "Theory of Bad Apples," the idea that quality is best achieved by discovering poor performers (doctors, hospitals, health plans) and removing them from the system. This is not to deny that regulators and others should continue to ferret out those plans and providers that are dangerously incompetent. This is clearly an important and necessary function. Rather, it is an argument for greater balance in the allocation of resources and effort.
The experience of other industries that have tried to address quality problems is that defects in quality are rarely attributable to a lack of will, skill or benign intention among the people involved in the production process. In most cases, problems are usually built directly into a complex production process. Even when people are at the root of defects, the problem is generally not one of motivation or effort, but rather of poor job design, failure of leadership, or unclear purpose (Berwick 1989).
Processes in the health care industry are highly complex. Laffel and Blumenthal (1989) cite the example of a cardiac catheterization laboratory, where each case requires four individuals to carry out 50 separate activities. The activities of each individual are linked to those of the other three through an exquisitely timed series of interactions, handoffs, and dependencies. This process is only one of hundreds that a patient might be part of during even the most routine hospitalization.
A problem with complex processes is that they are frequently characterized by rework and waste. Tests are repeated because they are not performed correctly the first time. Requisitions have to be rewritten because they are lost or filled out incorrectly. Other industries that have sought to improve quality have identified the elimination of waste as an important part of improvement efforts. (Womack, 1996). Berwick (1997) argues that "anything done in health care that does not help a patient or family is, by definition, waste, whether or not the professions and their associations traditionally hallow it." Process modifications that reduce waste and rework may simultaneously improve quality and reduce cost (Laffel and Blumenthal, 1989)
There is a growing recognition of the problem of error in medicine. In a widely cited 1994 article, Lucian Leape reviewed a number of studies and concluded that a significant number of hospital patients suffer injuries as a result of errors. Leape notes that focusing solely on injuries may actually minimize the extent of the problem because most errors do not result in injuries.
Given the complex nature of medical practice and the multitude of interventions that each patient receives, it is not surprising that errors are made. Leape concedes that given the large number of interventions, health care personnel are operating at a high level of proficiency, but notes that even a success rate of 99.9 percent may not be sufficient. Such a rate would allow for two unsafe plane landings per day at O'Hare Airport, 16,000 pieces of lost mail every hour, and 32,000 bank checks deducted from the wrong bank account every hour (Leape, 1994).
A number of "high risk" industries, such as aviation and nuclear power, have made dramatic strides in reducing rates of error by using "human factors research," which tries to understand how and why human beings make mistakes in order to design work environments that minimize the occurrence of errors and limit their consequences (Leape, 1994). For example, concentrated solutions meant for mixing with IV fluid, not direct injection, could be kept in needle-less syringes with locks that fit only into IV bag receptacles (Stahlhut and Gosbee, 1996).
In response to growing public concern about medical errors, the American Medical Association has launched a major new initiative--the National Patient Safety Foundation (NPSF)--dedicated to ensuring that all patients in all settings receive health services safely (AMA, 1997). The Foundation will compile and disseminate data on the causes and constructive responses to errors. The Foundation is inspired by the example of the Anaesthesia Patient Safety Foundation, which was established in 1985 to promote the development of knowledge and reduction of anaesthesia injury. Whereas mortality from anesthesia was one in 10,000 to 20,000 just a decade ago, it is now estimated at less than one in 200,000 (Leape, 1994).
Many health care facilities are taking steps to reduce error. The LDS Hospital in Salt Lake City, Utah has developed a computer system to identify, track and reduce adverse drug events (ADEs), the leading adverse event experienced by hospitals. The system, which contains information from the hospital's computerized patient records, can check a physician's prescription against known drug allergies and test results and can flag potential problems. The system is even capable of recommending an ideal dose of medication to the physician. The implementation of this system has significantly reduced adverse drug events in the hospital and has given the hospital an invaluable database of information that they have used to design methods of preventing ADEs (Evans, et. al., 1992; James, 1998).
Reducing error will also require a change in the way that health care organizations conduct themselves. In his testimony before the Commission, David Blumenthal (1997) noted:
"Right now, the detection of serious errors within hospitals and managed care systems often leads to the equivalent of a public hanging. Managers' first instinct is to identify a responsible individual and exact retribution...The effect of such public executions is to encourage health care workers to suppress evidence of error, and the suppression of such data deprives managers of information they need to improve health care processes. True quality improvement depends on the scientifically sound redesign of such processes and will not occur until the internal culture of health care organizations promotes greater openness, learning, and self-improvement."
The barriers to reporting of error are not only internal, however. The very methods that are needed to root out error — admitting it, measuring it, discussing it — have the side effect of providing evidence of error, evidence that quality oversight organizations and plaintiffs' attorneys are eager to see (Belkin, 1997; Leape, 1997). Changes in medical malpractice, tort, and quality oversight systems are also needed to create a climate in which errors can be more readily reported, analyzed and prevented, while still providing fair and equitable compensation to victims of error. Modern error reduction systems do not rely primarily on blame or punishment, since most errors are traceable to system flaws or inevitable human limitations that must be taken into account if safety is to be improved.
Building long-term relationships between stakeholders in the health care system is a critical part of improving quality. One of W. Edwards Deming's famous 14 points is to "end the practice of awarding business on the basis of price tag alone." Deming exhorted managers to develop long- term relationships with their suppliers, which he believed created the best climate for suppliers to be innovative and efficient (Deming, 1986).
The dramatic changes that have taken place within the health care industry over the past few years have made the development of long-term relationships more difficult. Group purchasers — both private and public — have made it clear that they are unwilling to accept the kind of cost increases that prevailed in the 1980s. Health plans and providers are under enormous pressure to contain costs. Subcontracting, competitive bidding, and the rebidding of existing contracts have all become key strategies in this effort.
At the same time, however, a number of health care organizations, understanding the need for long-term partnerships, are attempting to build lasting relationships with their suppliers. The Group Health Cooperative of Puget Sound health plan, for example, has a policy that it will not contract with any vendor that does not have a quality improvement plan in place. Group Health's Supplier Quality Certification Program rates suppliers in a number of areas, such as pro-active and continuous quality improvement initiatives, innovative solutions to customer requirements, women and minority business support, and environmental commitment (Group Health Cooperative of Puget Sound 1995). The Employer Health Care Alliance Cooperative in Madison, Wisconsin — a health plan purchasing cooperative for employers — has a key aim the identification of "quality, cost efficient providers for the purpose of entering into a long-term business arrangement. (Employer Health Alliance Cooperative, 1997)
Collaboration is a Key Tool for Improvement: Because health care organizations are such complex systems, improving their performance requires the participation of actors from many different parts of the system. Improving certain aspects of surgical performance, for example, may not be possible without improvements in how laboratory functions are handled and how information is recorded and disseminated. Improving care for a disabled elderly person may require improved coordination between a primary care physician, a home health nurse, and hospital staff, none of whom are employed by the same organization.
It is not always easy to bring individuals from different disciplines, departments, and organizations together but when it happens, the results can be dramatic. At Henry Ford Hospital in Detroit, an orthopedic surgeon convened a group of physicians, nurses, social workers, discharge planners and health plan administrators who were involved in the care of joint replacement patients to look at ways to improve the process of care. Within a year, the team had redesigned the care process and had begun treating one surgeon's patients under the new protocol, which emphasized standardized preoperative tests and increasing patient education about their expected recovery program. After a few months of tracking the first surgeon's patients, all three surgeons adopted the new care plan. These changes reduced the length of stay from an average of seven to ten days to an average of five days and increased patient satisfaction (Blumenthal and Edwards, 1995).
Relationships Between Administrators and Clinicians are Under Strain: The rapid pace of change within the health care industry is straining the relationship between administrators and clinicians. While surveys of physicians reveal that most are broadly satisfied with their work, many are frustrated with key aspects of their practice, especially their perception of a decrease in professional autonomy, a decrease in control over clinical decisionmaking, unreasonable delays in compensation, and the growing burden of paperwork. In some cases, the tension between plans and clinicians has entered the legislative arena in the form of debates over health system regulation.
Estrangement between administrators and clinicians leads to a number of problems. It creates morale problems among clinicians that can adversely affect interpersonal relationships with patients and the recruitment of new individuals into the profession. Estrangement also makes it harder for administrators to involve clinicians in quality improvement efforts, which is widely recognized as a critical factor in their success. Administrators and clinicians need to develop new ways of working together that allow potential conflicts to be identified and resolved before they begin to damage the relationship.
The experience of other industries that have undergone significant restructuring is that the most effective initiatives to improve quality and reduce costs are those that involve front-line workers in the planning and implementation of those initiatives. Berwick, Godfrey and Roessner (1990) note:
"One of the most striking discoveries of companies in the past twenty years is the power that comes from enabling all employees to become involved in quality control and improvement. It seems obvious that assuring and improving quality cannot be made the job of any single department, but for years companies (and health care organizations) tried to do just that. Organizations are now using increasingly innovative ways to encourage and capture ideas from all employees, not just managers."
Health care faces several barriers to the effective participation of all employees in quality improvement efforts. One key barrier, found in most industries, is fear, which is why quality expert W.E. Deming always exhorted managers to "drive out fear (Deming, 1986)." Many health care workers fear that if they report mistakes they will be disciplined or even fired. Every industry that has substantially reduced error has created a blame-free environment for reporting mistakes. In 1975, for example, the Federal Aviation Administration (FAA) and the National Aeronautics and Space Administration established the Aviation Safety Reporting System, which collects, analyzes and responds to voluntarily submitted incident reports in order to lessen the likelihood of aviation accidents (see Chapter 10).
An important aspect of fear is employee concern about job security. In an industry undergoing convulsive change, many employees fear that their jobs could be eliminated at any time. In such a climate, some employees may view quality improvement initiatives as a means of identifying which jobs are to be eliminated. While the significant overcapacity that exists in the inpatient hospital sector suggests that downsizing will probably continue, managers must find creative ways to respond to this concern if they are to succeed in involving employees in improvement efforts.
Another set of barriers to effective empowerment that must be surmounted are those that exist between disciplines, professions and departments within health care organizations. The distinction drawn in many facilities between "administrative" and "clinical" quality improvement efforts (see discussion above) is one such barrier, as are hierarchical relationships between administrators, physicians, nurses and paraprofessionals. Other industries struggling with quality problems have found that excessive deference to authority can occasionally prove fatal. The investigation of a crash of two 747s on a fog-shrouded runway in the Canary Islands found that one plane had a very good, but overly strong willed pilot. John Nance, an airline pilot and safety analyst noted that "His crew perceived him as so senior and so omnipotent that they weren't willing to tell him when he was doing something wrong. They just assumed that he must have known what he was doing (Belkin, 1997)."
A third barrier to empowerment is that large sectors of the health care industry, such as skilled nursing facilities and home care — are still characterized by low-wages, high-turnover, and high injury rates. This is particularly true of paraprofessionals. Of the two million health care paraprofessionals in the United States, over 600,000 of them are earning wages below the poverty line (Home Care Associates Training Institute, 1997). High levels of turnover make it difficult to tap the institutional memory and expertise of workers to make improvement in quality.
The challenge that health care leaders face is to eliminate these barriers and to cultivate a climate where all employees feel free to suggest innovations. In many cases, employees with good ideas remain silent because they assume that they will not be listened to. Effective health care leaders must find ways to engage the creativity of all of their employees, not just clinicians. The experience of health care organizations that have empowered employees to use their imagination and creativity is that the result is not only technically successful projects, but a sense of enthusiasm and enjoyment among the staff (Berwick et. al., 1990). Chapter 13 contains a number of examples of employers in the industry who have found ways to engage employees in quality improvement efforts.
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