The benefits of ISO certification and Total Quality Management in a radiology department

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1 H. P. A. Geraedts 1, R. Montenarie 1 and M. J. Hendriks 2 The benefits of ISO certification and Total Quality Management in a radiology department The Departments of Radiology, Radiotherapy and Nuclear Medicine of the University Medical Center in Utrecht, the Netherlands are combined within one decentralized division. In 1995 the division initiated a strategic planning process, resulting in a strategic vision and a mission statement. During the planning process, the division management concluded that development of an integrated quality system was of great strategic importance to the three departments of the division. Three motives prompted this conclusion. Firstly, due to government policy, our division faced an increasing demand for medical activities combined with decreasing budgets, making it essential to control both quality and costs. Secondly, many quality improvement projects had been carried out in the past, but due to the growing interrelation between the different projects, an integral and systematic approach was needed. Finally, legislation had been passed by which the Dutch government required healthcare organizations to operate a verifiable quality control system. After reviewing existing methods for design of quality systems, we chose to implement a system of quality assurance in accordance with the ISO 9000 standards. In January 1996, we completed the implementation of our ISO 9000 quality system within the Department of Radiology and obtained an ISO 9002 certificate. Now, three years later, we have reached the limits of benefits from the ISO quality system, and are focusing on widening our perspective on quality management. We have decided to adopt the principles of Total Quality Management (TQM). In order to translate these principles into everyday practice, we now use the Model for Business Excellence, as developed by the European Foundation for Quality Management (EFQM). This model can be considered complementary to the existing ISO 9000 system for quality assurance. In this article we first review the implementation of the ISO 9000 quality system in the Department of Radiology. We also discuss the benefits of working with the ISO 9000 standards, and explain why we have shifted our focus from ISO 9000 towards the EFQM model. Following an introduction concerning Total Quality Management and the EFQM model, we describe how we have used the EFQM model to date, and how we intend to implement TQM in the future. Quality assurance according to ISO 9000 standards About ten years ago the International Organization for Standardization issued standards for the design of quality assurance systems. These so-called ISO 9000 standards were originally designed for product manufacture, but are now used in a wide variety of organizations and industries. The standards offer sufficient flexibility to be applied in health care organizations, especially in a radiology department because it has many characteristics of a typical production organization. A quality assurance system as laid down by the ISO 9000 standards has three main characteristics: The principal focus is on the process of service delivery itself, not on the result. An integrated quality system is of great strategic importance. ISO 9000 industrial standards can also be applied to other organizations. 1 Division for Radiology, Radiotherapy and Nuclear Medicine, University Medical Center, Utrecht, the Netherlands. 2 Radiology Department, University Medical Center, Utrecht, the Netherlands. November

2 Total Quality Management complements the ISO quality system. There is a systematic approach. This implies that working processes and resources are identified, and that the performance is measured on a regular basis, using performance indicators. The system has to be verifiable by means of documents such as a quality handbook, procedures describing the most important working processes, standard operating procedures/instructions, and the measurement of performance indicators. All documents need to be updated, authorized and distributed according to standards for document control. Any improvement in the workflow necessitates an update of the specific procedure. Employees are informed immediately when they receive the updated procedure. Working with an ISO 9000 system has a number of benefits. Firstly, processes within the organization are transparent, enabling changes to be made in a controlled manner. This means, for example, that if a CT examination procedure is changed, it is immediately clear who needs to be informed and what documents must be updated. Furthermore processes are audited periodically by both internal and external auditors. Both audits are obligatory for maintaining a valid ISO 9000 certificate. Secondly, a strict document control procedure is part of an ISO-quality system. This makes it possible to create relevant procedures and protocols and to maintain them within the organization. Especially for technological departments such as a radiology department, maintaining relevant technical and working documents is vital for quality control. Furthermore an ISO 9000 quality system is quite suitable for seeking continuous improvement by means of performance indicators (Pi s). The organization has to decide which performance indicators are relevant for monitoring its processes and output. The next step is to set a minimum standard for each Pi that is both reasonable and acceptable. Establishing the method and frequency of the measurements are important factors. After these preparations, the actual monitoring of the Pi s can begin. If Pi results do not meet the given standards, it may be necessary to take corrective measures. The use of performance indicators can be a very confrontational instrument for monitoring quality. Within the Department of Radiology we have identified four categories of performance indicators: Production Costs and efficiency Process quality Customer satisfaction. Production The performance indicators for production the monthly production for each modality, compared with the target production for the whole year comparison with the production of the previous year. Costs and efficiency The performance indicators for costs and efficiency monthly depletion of staffing and material budget average number of full time equivalents (FTE s) in action production hours per FTE absenteeism. Process quality The performance indicators for process quality average examination time per modality film usage and waste percentage of available old examinations. Customer satisfaction The performance indicators for customer satisfaction telephone response time and waiting time at reception desk report turnaround time and waiting time before examination customer satisfaction survey comparison with results of previous surveys. The indicators related to the departmental production give a fair indication of the workload in proportion to the number of staff and the degree to which production agreements within our hospital are met. A very useful indicator appeared to be the number of production hours per FTE. Mismatch between required production and available personnel can be detected instantaneously. 52 November 1999

3 The indicators for process quality played an important role in improving the efficiency in our department. The average examination time per modality is measured periodically by means of our Radiology Information System (RIS) (Fig. 1). Waiting times (Fig. 2) and reporting times (Figs. 3, 4) are monitored intensively. Customer satisfaction is measured annually by means of a patient questionnaire. minutes An ISO quality system is a stable system within a dynamic organization. The changes made in the ISO quality system are incremental and incident driven. When a quality system is used for two to three years, the benefits from the system revoke to the basic benefits mentioned above. This means that in our division, where we had our first quality system certified in January 1996, we are now reaching the limits of the benefits of ISO. This was the main reason for considering a new model for quality management. We wanted to add a new dimension of systematic and continuous improvement to the existing model for quality control. The most important requirement for the new model was its ability to focus on both organizational and result aspects and the interaction between the two. We found our demands met in the Model for Business Excellence, developed by the European Foundation for Quality Management (EFQM). Total Quality Management and the EFQM Model The European Foundation for Quality Management defines Total Quality Management as All manners in which an organization meets the needs and expectations of its customers, personnel, financial stakeholders and society in general. This definition is fairly abstract since Total Quality Management (TQM) can be considered a philosophy rather than a model or a method. Many definitions are therefore used to describe it. However, it is widely accepted that TQM is based on three principles: customer focus; every decision is taken with the customer s needs in mind continuous improvement; continuous efforts to improve the organization, its products and its services Fig. 1. Average examination time per modality (1998). % minutes Fig. 2. Report turnaround time for clinical patient examinations (1998). Percentage < 2 days. % Fig. 3. Average waiting time before examination per modality. Fig.4. Report turnaround time for outpatient examinations (1998). Percentage < 2 days. X-ray US CT MRI Angio November

4 People management People satisfaction Leadership Policy & Processes Customer Business strategy satisfaction results Resources Impact on society Enablers Results Fig. 5. EFQM model for business excellence. The Model for Business Excellence serves as useful framework. integral approach; TQM concerns every aspect of the organization. Many tools, methods and models have been developed world-wide in order to give substance to the concept of TQM. In Europe, the Model for Business Excellence, issued by the European Foundation for Quality Management, has gained broad acceptance among both profit-making and non-profitmaking organizations. With this model, organizations can evaluate their progress towards Total Quality. The EFQM Model for Business Excellence consists of nine distinct areas, each representing a different aspect of the organization. These nine areas are subdivided into areas concerned with what results have been achieved (Results) and areas concerned with how these results have been achieved (Enablers). Figure 5 shows the nine areas and how they are related to each other. Table 1 presents the characteristics per area. The Model for Business Excellence serves as a useful framework within which to structure quality improvement efforts, because of its integrated cycle for continuous improvement. The cycle begins by carrying out a self-assessment to see what Results are achieved at a given moment. Based on these findings organizations can decide what improving actions must be taken to strengthen one or several Enablers, in order to achieve better results next time. For example: if an organization wants to improve People (employee) satisfaction, it has to strengthen People Management and also perhaps Leadership, and Policy and Strategy. This can be realized by improvement actions in these particular areas. After such improvement actions have been implemented, the organization again carries out a self-assessment in order to see if the improvement actions have resulted in a better overall performance. Based on this second assessment, new Result areas can be selected for improvement, and so the cycle begins again. At the end 1998 the management of the Department of Radiology launched a long-term project to implement the TQM principles, by using the EFQM model. The project commenced with a meeting for all our employees, to inform them about TQM, the EFQM model and the selfassessment, which will take place in the second half of The department is presently in the middle of a strategic planning process, which ends with a Strategic Plan , and a long-term investment plan. Meanwhile a patient satisfaction survey has been carried out and preparations are being made for the self-assessment and the implementation of a workflow management system. After the strategic planning has ended, a special task force will perform a self-assessment according to the EFQM Model for Business Excellence. The outcome of this self-assessment will be discussed in several meetings with groups of employees. 54 November 1999

5 Enablers Leadership Resources Policy and strategy People management Processes Open innovative culture, getting the job done Investments, use of equipment, patient information flow Policy deployment, policy is more than just a plan to purchase equipment Management by objectives, standards and values Use of process-related performance indicators, patient throughput Results People satisfaction Customer satisfaction Impact on society Business results Results of employee satisfaction survey, absenteeism Patients: complaints Referring physicians: number of repeat references Environmental care, relationship with patient organizations, free of charge examinations Financial: budget discipline Operational: number of examinations Table 1. EFQM model: description of the nine areas. Based on these discussions, a final conclusion will be drawn concerning the present position of the department on the areas of the EFQM model. The management team will then decide which areas will be the focal point for the next two years so that specific improvement projects can be developed. However, the EFQM is not only useful for future improvement initiatives. Current improvement projects can also be (re) prioritized and evaluated on the basis of the self-assessment. It is important to emphasize that the role of the ISO 9000 system is unchanging. It will still be used to control all the critical processes within our department. The ISO 9000 system can be regarded as a solid basis for all future TQM efforts. Conclusion Total Quality Management is an excellent model to use after successful implementation of an ISO 9000 Quality system. The EFQM model makes it easy to enlarge the scope of quality management, and to take an objective look at the organization and the results it achieves. Furthermore, it helps to set priorities in the improvement projects, and it is an adequate model for evaluation of the achieved improvements. Total Quality Management provides an excellent model. November

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