CQI: Changing Systems to Improve Quality Problem-solving teams adopt statistics-driven techniques developed for industry to bring about system improvements in health care. by Joyce Leinberger Mitchell

"In our outpatient pharmacy department, the system for processing prescriptions was out of control," says Paul Foley, supervisor of Ambulatory Pharmacy Services at Shands Hospital of the University of Florida in Gainesville. As recently as December 1990, patients were waiting an average of 82 minutes for their medications. Today, the average waiting time has been cut by 60%-to 33 minutes-and there are 15% fewer staff, working at a less stressful pace. (See "Shands, " p. 48). What brought about this dramatic change? Foley's department tackled the problem with a stnlctured, statistics-driven problem-solving process known as continuous quality improvement (CQI) or total quality management (TQM). CQI will be an inevitable part of health care 's future , many experts say.

System, Not People, Problems CQI is based on principles developed for industry by statistician W. Edwards Deming in the 1940s and successfully adopted by the Japanese. l Some 85% of problems are system problems, not people problenls, asserts Deming. Solving problems and stamping out fires are important, but they don 't change the system. Deming's approach-the CQI approach -continuously looks for faults in the system and ways to correct them, rather than focusing on individual performance. Deming's principles were rejected by American businesses in the 1950s, then rediscovered in the 1980s (see "Deming's Concepts, " p. 50). The revolution in American business that followed is now changing health care institutions. With burgeoning needs and decreaSing resources, health care institutions are fmding they are no longer impervious to customary business controls. Health care has turned to business for Vol. NS32, No.9 September 1992/731

examples of how to be competitive. "CQI is a whole new cultural mind-set," says Arthur Poremba, director of pharmacy at Fairfax Hospital, Falls Church, Va. "We're used to thinking, 'I know what the problem is,' and setting up ways to correct it. But what we think is the problem may not be, and we can only know that by collecting and analyzing data. " Poremba is part of a multidisCiplinary team using CQI techniques to study the problem of why medications are not available for administration when they are needed. (See "Fairfax, " p. 49). Specifically, CQI teams such as Foley's and Poremba's take a structured approach to problem-solving; they: • Identify a process that needs to be improved. • Collect data to verify a problem exists and determine why. • Use quality improvement tools to establish the root causes of the problem and determine what changes should be tackled first for the greatest results. • Develop recommendations for change. • Implement recommendations. • Check the results. • Establish procedures to ensure "holding the gains. "

Commitment Is Essential For a CQI program to succeed, staff must be trained in the new way of addressing problems, and must attend many meetings. This requires commitment from senior mant;lgement and staff, says Poremba. "It's a major time and resource commitment, and you can't initiate that from the department level. " AMERICAN PHARMACY

Shands Hospital's Foley agrees that you need to work with administration. "But we were actually doing CQI before the hospital administration began to promote CQI programs throughout the hospital. The administrators did support what we were doing, and now they are using outpatient pharmacy as one example hospital-wide of how the approach can work," he says. CQI also requires commitment among all team members, says Foley. "The CQI approach typically emphasizes a participative management approach, getting the on-line people involved in the problem solving and the solutions, " he says. Without their input, system problems will be missed. Quality improvement must be a continuous process, says Deming. Gene Blottner, assistant director of pharmacy at Sentara Norfolk General Hospital, in Norfolk, Va., agrees. Blottner 's department of 40 full-time pharmaCists , which administers about 200,000 doses per month, has two teams working on CQI problems at any given time. One CQI team recently fmished a project to correct problems in pharmacist scheduling, and two teams are now working on projects to

improve the system in the IV room and to improve communications. "Two teams are as much as we can handle at one time, without interfering with the workload," says Blottner. With direction and training from hospital management, CQI has become entrenched in Blottner's hospital; the radiology department recently won an award for its CQI effort, and the Nursing and Pharmacy Liaison Committee is changing its focus to become a CQI team to deal with lingering multidisciplinary problems. "In the past, the committee met to bring up problems, to see what we could do to solve them, but little was accomplished, " Blottner says. "We decided to use that liaison committee as a CQI team to address some of these problems."

Community Pharmacy Applications These techniques can be used in community pharmacy settings as well, says Timothy Burelle, vice president, professional relations, Big B, Inc., Birmingham, Ala. "Let's say a large chain of pharmacies is experiencing a

Shands Hospital: A cal Success Story The outpatient pharmacy at Shands Hospital of the University of Florida in Gainesville processes about 400 prescription orders per day, but in 1990 "the system was out of control, " says Ambulatory Pharmacy Services Supervisor Paul Foley. Patients were waiting an average of 82 minutes for their prescriptions, and "anytime you're behind an hour and a half, you're in a major crisis. " Foley was concerned about the department's turnaround time. Pharmacy resident Richard Faris was interested in improving the quality of care. Using continuous quality improvement (CQ!) techniques, together they began tackling the problem. Beginning in December 1990, they created a mechanism to record, and a computer system to measure, waiting times, to help identify the reasons for delays. And they involved all outpatient pharmacists in the problem. Next came two months of baseline studies, collecting data on the length of waits and the reasons for them. By March 1991, the pharmacists were ready to analyze the data, to identify what seenled to be the major causes of waiting-time difficulties, what times of the day or week were bad, and why Monday mornings always seemed to be the worst. The team held a brainstorming session to look at ways to reduce waiting-time problems. Some recommended changes to the system were implemented immediately; others were introduced in the following months. "A lot of the changes we made in March had a very significant impact right away, cutting the average waiting time in half," says Foley. Based on the data they collected, Foley's AMERICAN PHARMACY

group (1) opened a half-hour earlier; (2) shifted staffmg and scheduling patterns around to match the prescription arrival patterns; (3) shifted tasks that weren't time-sensitive from peak to slack times; and (4) added another computerentry terminal, because computer entry was a primary cause of the backlog at peak times. A consultant statistician helped Foley's group determine the statistical threshold level-the point at which the system is out of control and needs to be corrected. "We actually set up a lower threshold level than the one statistically derived," Foley says. "We had rather ambitious goals to reduce waiting time, and we wanted to use a nice rOlmd number that everyone could buy into. " Based on the baseline data, the statistical analysis showed that the threshold was about 70 minutes. "We were striving for an average time of about 30 minutes, so we decided to set our threshold tinle at about 60 minutes. Anything over 60 minutes means the system is out of control. " By August 1991, major changes or modifications to the process were completed. After analyzing the system and making some changes to solve identified problems, the average for the week was 42 minutes-a 48% reduction. When the project was completed, waiting time was down 60%. "Finally we were at a point where this team project was no longer the thing that everyone spent their time on," says Foley. "Now we'll continuously monitor times one week a month, look at trends, and see if the waiting time is going up or down. "

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Fairfax Hospital Implements a cal Team Effort Like many hospitals with continuous quality improvement CCQI) programs, Fairfax Hospital in Falls Church, Va., tackled an identified problem within the system by assigning teams of staff from each of the involved dep artments. Director of Pharmacy Arthur Poremba joined representatives from pharmacy management, a nurse manager, staff nurses, a pharmacy technician , and a staff pharmacist to frod out why medications aren't available for administration when they are needed. Poremba, who was chosen team leader, is responsible for setting the agenda for each lneeting, working toward a consensus, and making sure that all team members are involved and no one person monopolizes the meeting. "In the beginning, there is a tendency to point frogers, to fix blame," says Poremba. As the process evolved, team members recognized that problems were system related, not departmental. Also appointed to the team is a facilitator-someone from outside the department and not involved in the problem. The facilitator provides an objective viewpoint, observing what the team is doing, giving guidance regarding the CQI process, and helping the team select the appropriate tools for analyzing the problem.

CQI requires looking at problems in a new way, and this requires training. Fairfax Hospital is part of the Inova Health Systems, a corporation that includes three other hospitals and several outpatient facilities. To make sure the program at Fairfax got off to a good start, the corporation's Quality Improvement Division set up an extensive training p rogram. Department nlanagers received at least one day of training, team leaders and facilitators received one week, and all staff have at least one hour of training in the CQI process. Every meeting of Poremba's team starts with a team-building exercise, designed to break down barriers between departments and individuals. "They work, " says Poremba. "I can see bonding taking place. We've established strong working relationships." The process is an "exercise in patience, " acknowledges Poremba. His team held its flfst meeting, September 12, 1991, and they have met for about 11/2 hours every one to two weeks since then. "We're only now beginning to analyze the data," says Poremba. "We have only come this farand actually, we're doing well, from what I hear. "

very high prescription error rate. In a company not yet committed to CQI, the typical response of top management would be to criticize pharmacists for their carelessness. But in a company committed to CQI, managenlent would react very differently," says Burelle. The managers would form a team of pharmacists to study the problem. This team would look at the number and types of errors and the conditions under which the errors are occurring. The data they collect might lead the CQI team to conclude that many factors are contributing to errors in the prescription dispensing "system" being used in the chain's stores. Team members would prioritize these factors using statistical, quality improvement tools, and propose changes in the system that they believe would reduce the errors. Emphasis would be on changing systems with the most potential for improvement. These might include workflow, pharmacy layout, computer software, or pharmacists' training. Management would provide the resources to test these proposed changes on a small scale, and if the test was successful , they would make the changes permanent and expand thenl to other pharmacies as well. Management in such a company would also recognize the team members for their significant contribution to improving the company, says Burelle. "In recognizing team efforts, management encourages employees to continue their participation in the quality improvement process."

Figure 1

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en 50

Q) (J

c 40 Q) loa loa


(J (J


0 'too





.c 10 E ::s


0 Computer

Problem Rx



Cause of Outpatient Waiting Time

This Pareto diag ram dramatically shows th at th e prima ry ca use of excessive wait ing times for prescription s at Shands' pha rmacy was computer entry. From Reference 4; used with permission.

Statistical Tools Seven basic statistical tools are available to help pinpoint the areas that need work. "We used flow charts and run charts," says Foley, "and we used a lot of Pareto diagrams AMERICANPHARMACY

[see Figure 1]. They helped to simplify some of the ideas and give very clear pictorial representations to the staff and to others of what the problems really were." "Diagramming is very enlightening," Norfolk's Blottner agrees. "Before, some of our staff had no idea how difficult special requests for time off made the job of scheduling. Now they appreciate our effort to accommodate their needs. " Besides the Pareto diagram Foley used, graphic tools include the flow chart, which shows the steps in a process; the run chart, which shows results plotted over time; the

Deming's Concepts in Health Care The statistics-driven approach to quality improvement was developed by Deming and others during World War II for American wartime industries. To reduce waste and costs, business adopted statistical quality control concepts published by statistician Walter Shewhart Deming in the 1920s. Shewhart encouraged enhancing quality with a continuous cycle, known as the Shewhart Cycle or the Plan-Do-Check-Act Cycle: Plan how to improve the process. Do -collect data. Check the results. Act to standardize the change and begin the cycle over again. But in the postwar years, Americans were voracious consumers of goods, and manufacturers were not interested in Deming's quality-driven techniques. They opted instead for quantity. America's management style remained autocratic and "unresponsive to both workers and customers," in Deming's opinion. 1 Then in 1950, theJapanese, looking for ways to compete for business, asked Deming for help. Using the statistical methods and management techniques that Deming taught them, the Japanese developed a management style that recognized the knowledge of each employee and involved everyone in fmding ways to improve quality and meet customer needs better than their competitors. By 1980, American manufacturers had come to realize the Japanese were winning customers, not just by copying American products, but by improving them. Interest in Deming's techniques grew with an NBC documentary in 1980, and the auto industries began to learn and successfully use continuous quality improvement. 1 AMERICAN PHARMACY

cause-and-effect ("fishbone") chart; the histogram, which shows how often something occurs; the scatter diagram, which shows the relationship between two variables; and the control chart, which establishes lower and upper statistical threshold limits of acceptable system performance, beyond which action may be needed to get the system back on track. "The CQI process is statistically oriented and data driven," says Burelle. "That shouldn't deter pharmacists from adopting it. The tools are simple to use. To collect data, you can start with a free-form checklist of, for example, possible reasons why errors occur and enter the information in a familiar spread-sheet program on the computer, or graph it on paper. Once you get your observations in the computer, you can do a histogram." Overcoming the problems in introducing CQI in the community pharmacy will not be easy, cautions Charles D. Hepler, professor and chairman, College of Pharmacy, University of Florida. "The major issue is that there is no systematic way to observe, document, and communicate outcomes in the community pharmacy. CQI is therefore difficult to implement," he says. The solution, says Hepler, is to develop such systems, and possibly the third party providers could do this. "They could create indicators of outcomes after the pharmacist provides counseling and care. An indicator could be visits to the emergency room, or readmissions of asthma patients to hospitals-this has already been created for the hospital setting" (Figure 2).



Programs in Health Care?

Over the past decade, CQI in health care has been fostered by several factors: • The spiraling costs in health care have led to a government focus on reducing costs. Diagnosis-related groups (DRGs) that capped hospital reimbursement for standard procedures were introduced, hospitals were motivated to discharge patients sooner, and pharmacists' dispensing fees were discounted. "The demand side-the third party providers-took over, " says Hepler. "Health care providers, alarmed that they were being forced to do things they didn't want to do-like discharging patients early- fmally said, Things are out of control; let's make clear what quality care is.' They began to look for ways to improve quality without increasing costs," says Hepler. • In 1986, the Joint Commission on the Accreditation of Healthcare Organizations OCAHO) initiated its Agenda for Change, which shifted JCAHO 's focus from reviewing procedures (determining if they were performed, in the prescribed manner) to looking at outcomes. Hospitals initiated systems designed to ensure they are prepared to show outcomes when JCAHO asks for that information. ]CAHO and health care institutions previously emphasized September 1992/734

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preventing "worst-case" scenarios with quality assurance - methods used to ensure that products have been prepared according to required standards. But they recognized that quality assurance has no effect on the overall quality of health care-it doesn't raise quality to a higher level (Figure 3), and CQI can . • With p a tie n ts l eaving the hos p it al sooner and opening up b eds, compet ition among local institutions to attract physicians and patients increased. Institutions needed to increase their competitive edge, and they turned to the business world to fmd out how. • Computerization of patient records made it possible to use data to pinpoint where problems most frequently occur. With this information, teams of experts could work to resolve the problems.


Figure 2


Practitioner General Health Status Competency

Recent ED Visit

Compliance Behavior

Asthma Readmission Within 30 Days

Patient Education Support Personnel

Organizational This fishbone, or cause-and-effect diagram, is a schematic of the hospital indicator of outcomes in asthma treatment adopted by the Joint Commission on the Accreditation of Healthcare Organizations. From Reference 5. © American Society of Hospital Pharmacists, Inc. Reprinted with permission.

Figure 3

COl and Pharmaceutical Care For pharmacy, an additional impetus to adopt CQI techniques came from the recent push for change within the profession, which culminated in adoption by APhA of a new mission for the profession:


Worse Quality


Worse Quality Better

to serve society as the profession responsible for the appropriate use of medications, devices, and services to achieve optimal therapeutic outcomes.

"CQI fits naturally with the new mission statement and the new focus on pharmaceutical care," says Lucinda Maine, senior director for pharmacy affairs at the American Pharmaceutical Association. Pharmaceutical care- "the concept of working with a patient and other health professionals to design, implement, and monitor a drug therapy plan that will improve a patient's quality of life"-was articulated by Hepler and Strand in 1990. 3 Says Hepler, "The connection between CQI and pharmaceutical care is to pay attention to outcomes-dOing a job right the first time. " "Much of what we 're doing in practice today is not consistent with CQI and pharmaceutical care," says Maine. For example, an elderly patient with newly diagnosed diabetes Vol. NS32, No.9 September 1992/735








Impact of Standards vs. CQI. Quality assurance prevents worst-case scenarios, but does not improve the quality of care; correcting the system does. From Reference 6; used with permission.

came to a hospital pharmacy with her insulin in hand. She was looking for instructions on its use. The label said simply, "Use as directed. " Technically the dispensing pharmacist had AMERICAN PHARMACY

practiced within the letter of the law, but he had not provided pharmaceutical care, notes Maine. "If the pharmacist dispensing the insulin had focused on 'what does my customer need,' he would have counseled her on the proper way to use insulin," says Maine. But pointing a fmger at the pharmacist for not counseling the patient may be inappropriate.

Table 1

Deming's 14 Points 1. Create and publish to all employees a statement of the aims and purposes of the company or other organization. The management must demonstrate constantly their commitment to this statement. 2. Learn the new philosophy, top management and everybody. 3. Understand the purpose of inspection, for improvement of processes and reduct io n o f cost. 4 . End the practice of awarding business on the basis of price tag alone . 5 . Improve constantly and forever the system of production and service. 6. Institute training . 7 . Teach and institute leadership . 8. Drive out fear. Create trust. Create a climate for innovation. 9. Optimize toward the aims and purposes of the company the efforts of teams, groups, and staff areas. 10. Eliminate exhortations for the work force . 11a. Eliminate numerical quotas for production. Instead, learn and institute methods for improvement. b. Eliminate M.B.O .* Instead, learn the capabilities of processes, and how to improve them. 12. Remove barriers that rob employees of pride of workmanship. 13. Encourage education and self-improvement for everyone. 14. Take action to accompl ish the transformation. From: Reference 2. Used with permission of MIT and W Edwards Deming, PhD. *M.B.O.=Management by Objectives.


Focus on Customer In his 14-point program (Table 1), Deming calls for a refocusing on the customer. 2 "'Customer' lneans who is getting the product or service from you," says Debra Weintraub, pharmacy manager at Suburban Hospital in Bethesda, Md. In the past, the term customer was seen as a business term, and health care providers were trained to think in terms of the patient. Focusing on the customer is now being accepted by health care organizations, however, because they are operating as businesses. "They fmally faced up to the need to do that," she says. According to Maine, "our customers say they want convenience, price, location, and a nice pharmacist. They don 't know that what they really need is a much higher level of service. They need to know unequivocally how to take their medications. The woman with the insulin would say, 'Yes, that's exactly what I need. '" Quality is your customer's perception of your goods and services, says Weintraub. "If you can make your customers all think or feel that they've gotten nlore than they expected, you've improved the quality. To Mrs. Jones, who is waiting for her prescription, faster service is quality care, because it is important to her." Suburban Hospital has trained every employee to think in terms of customer satisfaction, from answering the phone to following up on customer needs, says Weintraub. The hospital's new customer-service focus has improved quality of care: data show a decreased length of stay for certain diseases and shorter times for some procedures, and health care technology in the hospital has been updated. In a CQI program now being developed at the hospital, teams are being formed to look at the time it takes from admission of a heart attack patient to the time that patient receives thrombolytic nledication. "We're looking for ways to reduce the time, but we're also evaluating when delays are justifiable and acceptable," says Weintraub. "We want to see that justified delays are incorporated into the standard of care. "

The Right Thing to Do Most agree that CQI in health care is here to stay. The process of change is slow, but it will happen. "It's just the right way to do things," says Burelle. "And if you do things correctly in the ftrst place, the cost of health care will go down; hospital admissions and lost productivity caused by illnesses incorrectly treated will go down." People experienced with CQI say attitudes must change, and as results show improvement, they will. "There was some healthy skepticism from our staff when we began," says Foley. "We involved the entire department, and we began showing them good data they had never seen before. The Pareto diagrams also helped. We got past their skepticism and cynicism in the fITst couple of months. After that, September 19921736

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everything was very positive." Blottner has been a believer in the use of CQI teams to solve problems ever since he went through training in the process. "Some staff members think the process takes too long, but we've shown that trying to solve some problems quickly is like trying to put on a Band-Aid and it just doesn't hold. If you need a CQI team to solve a problem, it's not something you can do with a quick flX. " Poremba acknowledges that his attitude has changedsomewhat. "I was very skeptical at first. You begin, thinking 'I know the answer to this problem. Is putting in all this time really going to have an impact? Will we be able to implenlent our recommendations?' "Now I'm a believer in the program. We've identified causes of problems that we'd have missed the old way. I'm eager to see whether things really will be changed for the better. "

Joyce Leinberger Mitchell is senior editor, American Phamlacy.

References 1.

Walton M. Deming Management at Work. New York: GP Putnam's Sons, 1990.


Deming WT. Out af the Crisis. Cambridge, MA: MIT Center for Advanced Engineering Study, 1986.


Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hasp Pharm. 1990;47:533-43.


Faris RJ, Foley PT, Vining GG, et al. Continuous quality improvement techniques applied to outpatient pharmacy. Paper presented at the American Society of Hospital Pharmacy Midyear Clinical Meeting, held December 1991 in New Orleans, La.


Angaran, OM. Selecting, developing, and evaluating indicators. Am J Hasp Pharm. 1991;48:1931-37.


James BC. Quality Management far Health Care Delivery. Chicago, III: The Hospital Research and Education Trust, 1990.

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CQI: changing systems to improve quality.

CQI: Changing Systems to Improve Quality Problem-solving teams adopt statistics-driven techniques developed for industry to bring about system improve...
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