Structured Model for Healthcare Job Processes: QMS-H

Munechika, Masahiko Structured Model for Healthcare Job Processes: QMS-H Munechika, M. 1, Tsuru S. 2, Iizuka Y. 3 1: Waseda University, Tokyo, Japan 2, 3: The University of Tokyo, Tokyo, Japan Summary Our society requires the technology to provide safe and high quality healthcare. To this end, a Quality Management System (QMS) is essential in every hospital. QMS is a mechanism or work procedure designed to achieve and maintain quality. The authors formed a Quality centered Management System for Healthcare (QMS-H) Research group that, in collaboration with eight hospitals, attempted to develop, implement, and promote a QMS-H model. In this paper, we first describe the basic concept and significance of the QMS. Next, we present an in-depth discussion of QMS-H and examine its elements in detail. Then, we introduce the activities conducted by the research group, providing demonstrations of how the QMS-H system works. Finally, we discuss what is needed to establish QMS-H as a social technology. Keywords quality management system for healthcare, visualization of tasks, standardization, process flow chart, social technology 1. Introduction The main reason why quality assurance in healthcare is important may be the frequent occurrence of medical accidents. However, the complexity of the profession s recent technological advances requires us to synchronize the sector s prevailing quality assurance system with the changes occurring at the team and organizational levels. Therefore, we must adopt an approach to quality in the healthcare sector that is more systematic than the current approach, which removes the onus from the individual. Our society requires the technology to provide safe and high quality healthcare. To this end, a Quality Management System (QMS) is essential in every hospital. The ISO 9000:2005 defines QMS as a management system to direct and control an organization with regard to quality. In other words, QMS is a mechanism or work procedure designed to achieve and maintain quality. More concretely, we may say that it is a system that uses documents to list guidelines defining work procedures, such as quality manuals, instruction manuals, and records, and resources, for example, people and equipment. QMS has long been used in industry; it has established itself as a method of providing high quality products. However, as healthcare and industry have very different quality-control dimensions, developing a QMS model that is appropriate for the specific needs of the healthcare sector is an urgent task. The authors formed a Quality centered Management System for Healthcare (QMS-H) Research group that, in collaboration with eight hospitals, attempted to develop, implement, and promote a QMS-H model. In this paper, we first describe the basic concept and significance of the QMS. Next, we present an in-depth discussion of QMS-H and examine its elements in detail. Then, we introduce the activities conducted by the research group, providing demonstrations of how the QMS-H system works. Finally, we discuss what is needed to establish QMS-H as a social technology. 2. QMS and Its Significance QMS is fundamentally a method of maintaining quality assurance. System-based quality assurance is founded on the assumption that a high standard of quality can be achieved independently of individual abilities when jobs are done according to a defined process. Skill-levels across a team of doctors or nurses are obviously not consistent; individual efforts must bridge this disparity. However, the standard of healthcare should be independent of individual skill levels: a patient would not tolerate poor treatment caused by the insufficient skill levels of the doctors and nurses involved. Hence, the quality of healthcare must be assured by a system that is independent of individuals skill levels. A QMS defines the manner in which this kind of healthcare can be provided. 1

We hope to develop a perfect system, like the one described above, yet it is very difficult to develop a perfect system from scratch. A more feasible approach would be to determine what is possible, create a new system that attempts to emulate an achievable ideal, and then continually improve that system. Improvements are achieved by rotating the Plan-Do-Check-Act (PDCA) cycle; however, depending on individuals for this process will yield unwanted personal actions and countermeasures, which will cause further complications. Hence, we must use a mechanism that can rotate the PDCA cycle comprehensively in order to improve the organizational setup. A QMS that incorporates such a step-by-step improvement will be nearly perfect. As described above, developing a QMS requires visualizing jobs, standardizing them, performing them according to the relevant standards, and improving them (as per the rotating PDCA cycle) when and if problems occur. In this case, as P of PDCA is standard, we call it the SDCA cycle (Fig.1). In Fig.1, the job flow image is drawn in the S part. It is absolutely essential to visualize job flows according to specific job units and by specific methods. We select the Process Flow Chart (PFC) to visualize job flow. Examples are shown later. In developing QMS-H, we must consider other elements besides the visualization and standardization of jobs. We present the essential elements and the overall picture of QMS-H in the next section. 3. Elements of QMS-H and the Overall Picture 3.1 Elements of QMS-H Fig. 1 SDCA Cycle QMS-H is a mechanism or work procedure that ensures a consistently high quality of healthcare. The elements of QMS-H are derived from the resources necessary to accomplish the given task. (1) Procedure guidelines Instruction manuals are the documents that typically define work procedures, such as those for the auditing of prescriptions, the treatment of infections, etc. Clinical pathways that standardize treatment procedures are also procedure guidelines. (2) Equipment used to perform tasks Devices such as transfusion pumps, respirators, stretchers, medication carts, and automatic test devices are often used in the performance of typical healthcare tasks and thus constitute elements of QMS-H. Equipment maintenance and precision control, necessary to keep the devices in good condition, are also part of QMS-H. (3) People who perform tasks Employees perform their tasks using the necessary equipment in accordance with procedural guidelines. To do this effectively, people must be sufficiently competent. Consequently, education is key to quality assurance: a learning system is an essential element of a QMS-H. Furthermore, people who work for organizations are designated according to the role of the department or division to which they belong. Specifying work procedures requires the determination of the necessary 2

departments and their roles. Thus, organizational structure, responsibility, and authority must be determined in order to define the work procedures. Consequently, organizational structure, responsibility, and authority are also elements of the QMS-H. (4) Improvement mechanisms A QMS-H that incorporates step-by-step improvements will be close to perfect. Incident reporting systems and policy management, typical organizational improvement methods, are key elements of the QMS-H. Committees are organized to resolve interdepartmental problems, as hospitals do not dedicate departments to that task. These committees play crucial roles in making improvements in the QMS-H. (5) Leadership of top management The promotion of organizational improvements requires top management to be aware of the necessity for those improvements and to demonstrate good overall leadership. Thus, top-management leadership is essential to the effectiveness of QMS-H. (6) Management principle, vision, strategy, and policy Management principle, vision, strategy, and policy form the bases of organizational management. The implementation of QMS falls under the jurisdiction of organizational management. Thus, management principle, vision, strategy, and policy drive the decisions concerning the type of QMS to be established, the purpose and goal of the implementation, and the issues to be focused on. Therefore, a QMS-H should involve the determination, implementation, and management of the bases of organizational management. 3.2 Overall Picture of QMS-H We should define a hospital s work processes and visualize the relationships among those processes in order to clarify the QMS-H at the macro level. Then, we will analyze the manner in which the abovementioned elements can be incorporated into the QMS-H. The authors defined the work processes typical of a hospital, examined how to incorporate those elements into the QMS-H, and described the relevant quality assurance system in a chart. This chart is quite large, and hence we only describe the outline of the system. Medical care is obviously the core process in a quality-assurance system. The two management processes of support-process management and function-liaison management support that core process. Framework management and cross-functional management serve to manage the overall directions of these three processes. We extract and deploy 57 functional elements necessary for the 5 management processes for our QMS-H. For example, policy management, system assessment (internal audits, management reviews, etc.), and system improvements are included as part of the framework management function, while admission management, medical care management, and discharge management form part of the medical-care process management function. Our research group has examined a method that realizes these functions. 4. Activity of the QMS-H Research Group 4.1 Purpose of the Group and Research Activity Conducted The authors have conducted the QMS-H research group for two years in order to discover the most effective way to implement QMS-H in hospitals. The purposes of the group are as follows. 1) To propose a QMS-H model in accordance with the needs and characteristics of the healthcare sector 2) To plan an effective and efficient process for introducing and promoting QMS-H 3) To prepare an organizational structure for introducing and promoting QMS-H and to systematize its instruction to staff The group works as follows. First, the hospitals in charge of developing a QMS model collaborate with us to develop the model and a method of introducing and promoting it. The hospitals in charge of verifying the model try to introduce and promote the model autonomously; we provide the hospitals with any assistance required during the verification trial. Following this, we conduct monthly meetings with the two hospital groups to review their progress and discuss any issues they encountered during the model s introduction and promotion. We incorporate the results of these discussions, and then the work of promoting the model continues. The details of the hospitals taking part in the research group are provided below. The following hospitals are in charge of developing the QMS model: 3

A) Hitachi Mito General Hospital (Acute care, 215 beds, certified in 2001) B) Jouto Central Hospital (Acute care, 233 beds, certified in 2003) C) Aso Iizuka Hospital (Acute care, 1165 beds, started operations in 2006, certified in 2008) 1) The following hospitals are in charge of verifying the model: D) Sendai Medical Center (Acute care, 698 beds, started operations in 2007, certified in 2008) E) Ooguno Hospital (Nursing home care, 174 beds, started operations in 2007, certified in 2009) F) Maebashi Red Cross Hospital (Acute care, 592 beds, started operations in 2007, to be certified) G) Musashino Red Cross Hospital (Acute care, 611 beds, started operations in 2007, not aiming for certification) H) Satte General Hospital (Acute care, 192 beds, started operations in 2009, to be certified) Although hospitals A and B already possess ISO 9001 certification, they aim to redevelop their QMSs, since the current systems exist in name only. Hospital C first introduced QMS-H in a single department and later implemented it across the entire hospital. Hospitals D, E, F, G, and H have no prior experience with QMS. Note that hospitals A, B, and C developed the QMS-H model, while hospitals D, E, F, G, and H verified it. Of the 9,000 hospitals in Japan, around 200 are ISO 9001 certified. The majority of the 200 hospitals used external consultants for certification. Our research group insisted that the participating hospitals visualize and develop their QMSs on their own, as we believe this approach to be necessary for the establishment of an effective QMS. Note that the ultimate goal of each hospital is not ISO 9001 certification but the establishment of a QMS that ensures a consistently high quality of healthcare. 4.2 Outcome (thus far) All the elements mentioned in section 3 must be developed in order to establish QMS-H; however, this development must occur step by step, as it is very difficult to develop these elements simultaneously Moreover, it is much easier to use an existing QMS model as the basis for an improved one than to develop a new model from scratch. Many models can be used as a basis, such as Total Quality Management (TQM), Six Sigma, Balanced Score Sheet, and so on. Our research group adopted ISO 9001 for our QMS. Though only half the work of establishing the QMS-H has been completed, the foundations of QMS-H have been laid, and many hospitals have now obtained ISO 9001 certification (some obtained it 3 years ago). Issues and outcomes thus far are shown in Table 1 and Table 2. The most significant issues of the first 2 years have been the visualization and standardization of healthcare procedures and the implementation of daily management practices based on these standards, which represents the first step toward the establishment of the QMS-H. In fiscal 2009, some hospitals began to improve at the organizational level. Some of the results of our work are described below. Table 1. Issue and Outcome in 2007 & 2008 Issue Outcome Clarification of necessary processes QMS-H model Visualization & standardization of job processes Visualization of treatment & nursing processes Documentation Documentation system Check in PDCA cycle Management index Method of internal audit Examples of management index Introducing & promoting QMS-H Step of Introducing & promoting QMS-H Table 2. Issue and Outcome in 2009 Issue Outcome Improvement at the organizational level Achievement of policy & objectives Method of problem solving based on the hospital policy Introducing & promoting QMS-H Step of Introducing & promoting QMS-H Deployment of introducing & promoting plan Education system Systematizing contents of quality & safety education for healthcare Basic seminar for QMS-H Development methods for management & Analysis method of medication incidents, method of improvement planning countermeasure Model for planning management to prevent falling Mapping model for healthcare jobs & people 4

(1) Visualization of the procedures involved using a Process Flow Chart and developing an activity elements list Visualization of the procedures is a basic activity in QMS. Our research group tried to visualize these using a Process Flow Chart (PFC). However, we found that current PFCs have not led to improved business processes. We analyzed the PFC problems that have hindered improvements by using the proceedings of internal audits and committees. Following this, these points became clear: - The PFCs are incomplete and thus cannot lead to improvements. - The units of PFCs and the elements described therein (activity elements) vary among individuals. Thus, we conclude that PFCs cannot be used for further improvements because the PFCs are not understood by medical professionals other than those who develop the chart: this pre-empts any mutual understanding and renders PFC activity elements unclear. Elements that have scope for improvement are undetectable because the units involved in the management of diagnosis and treatment processes are not clear. Therefore, it is essential to clarify the units in the PFCs and to standardize and systematize the activity elements that need to be described in order to visualize and improve the processes. Our research group developed clinical PFCs to describe the processes involved in the diagnosis and treatment offered to patients from the time of hospitalization to discharge. Since it is not possible to describe all the processes in a single PFC, a PFC includes only those processes routinely used in diagnosis and treatment. Other processes are sometimes presented as subroutines using software engineering in order to describe the methods in a layered structure. The PFC for a subroutine is designated as a sub-pfc. Furthermore, all the activity elements useful in creating standardized and systematic PFCs are included in the list of activity elements. The activity elements list is standardized, and the elements are arranged to help in managing and improving the diagnosis and treatment processes by including the processes routinely performed by medical professionals. Standardizing the activity elements enabled us to compare the processes between departments, wards, and medical institutions. (2) Improvement at the organizational level based on the hospital policy In fiscal 2009, the third year of the QMS-H research group, two hospitals began to improve at the organizational level based on the hospital policy. These hospitals experienced higher human resource development, a lowered average period of hospitalization, a higher rate of bed availability, and fewer incidents (among other improvements). It is no exaggeration to say that the purpose of introducing QMS-H is the promotion of organizational improvement. However, many efficiency and problem-solving issues remain. Problems such as ambiguity of problem definition, inadequate targets, lack of knowledge, and inadequate data collection frequently occur, chiefly because medical professionals have little experience with quality-improvement and problem-solving techniques; problem-solving is a very difficult skill for even non-medical professionals to master. Hospital staff must learn general procedures for problem-solving, such as QC story and gain experience of them though their job training. (3) Development of a method of introducing and promoting QMS-H in hospitals A detailed plan is needed for the introduction and promotion of QMS-H in organizations, even if the QMS model is completed. We developed steps of doing it through the experience of introduction and promotion in three hospitals. The steps are composed of 11 steps below. Step 1: Learning what QMS-H is Step 2: Defining the position of QMS-H and identifying an attainable policy/target Step 3: Appointing a person/group in charge of introducing and promoting QMS-H Step 4: Declaring top management s intention to introduce and promote QMS-H Step 5: Designing QMS-H and clarifying its relationship to activities thus far Step 6: Planning a detailed schedule for the introduction of each QMS-H element Step 7: Determining the organizational structure of the group tasked with introducing and promoting it Step 8: Holding a seminar to educate members regarding QMS-H activities Step 9: Starting activities according to the plan and managing progress Step 10: Starting the operation of QMS-H Step 11: Improving QMS-H on a continual basis We introduced and promoted QMS-H to 5 hospitals according to these steps. We found that the visualization of job processes is the most important element of step 9. Furthermore, we believe that both introduction and promotion must be implemented autonomously, without the use of consultants. (4) Development of a basic seminar for QMS-H As mentioned in 3.1, education is essential to the development of an effective QMS-H. First, we extracted the 5

items on which people would require instruction from the QMS-H model. Second, we isolated instruction topics flowing from problems that occurred during the introduction and promotion phases. We developed a curriculum composed of 14 items using this analysis. The items are divided into 5 categories: basic concepts of QMS, visualization of job processes, tools needed for improvement, medical safety management, and methods of introducing and promoting QMS-H. We offered this curriculum to medical professionals during a seminar and sent out questionnaires to evaluate their degree of understanding. Their degree of overall understanding was fair; however, their grasp of PFC and document control was poor, these items being unfamiliar to medical professionals. It is thus necessary to improve the way those topics are taught, including the use of real-world examples. 5. Conclusion and Future Issues In this paper, we explain the significance of QMS-H, the most fundamental medical social technology, and propose the QMS-H model. Furthermore, we describe the activities of our QMS-H research group, which undertook a demonstration of the QMS-H. The foundation of the QMS-H has now been laid and its organizational improvement has begun. We outline several outcomes in section 4. A method of introducing and promoting QMS-H in hospitals and educating staff about it is key to its spread as a medical social technology. QMS-H may well become recognized as a commonsensical norm if 500 to 1,000 hospitals out of the 9,000 hospitals in Japan implement it. The method of introducing and promoting QMS-H and the system of QMS-H education must be established if QMS-H is to spread as widely and quickly as it needs to. Acknowledgement The authors gratefully acknowledge the generous assistance of the members of the QMS-H research group. 6