Implementation of a Quality System for Medical Physics Patient Radiation Protection Management based on ISO 9001:2000

Transcription

1 Implementation of a Quality System for Medical Physics Patient Radiation Protection Management based on ISO 9001:2000 Sáez C, Gimeno V, Seoane A, Hermida M Servei de Física i Protecció Radiològica, Hospital Universitari Vall d Hebron, Pg. Vall d Hebron , E-08035, Barcelona, Spain. menchu@vhebron.net 1

2 Abstract. The purpose of this work is to design a quality management system (QMS) model for the Medical Physics department (MPD), emphasizing the physical criteria implied in Radiotherapy, Nuclear Medicine and Radiology quality assurance (QA) programs for patient radiation protection. Main processes and activities are identified, assigning responsibilities and involving top management. Regulated quality relationships between MPD and clinical departments are also included. Implied criteria are implemented in compliance with the Spanish legislation and following international recommendations. The chosen norm is the ISO9001:2000, which establishes the responsibility of the Hospital management and the person in charge of the MPD in the QMS, the management of the resources, procedures and measurement and analysis, all focused on a continual improvement. Performance indicators are defined to measure, analyze and improve the system. As a consequence of QMS implementation the following standardized and codified manuals have been obtained: (1) Quality Manual: defines the system and the quality policies of the MPD. (2) Process Manual, with three kinds of managed processes: Strategic (management of responsibilities and tasks, training, etc.); Operative/Key: (for radiation sources, measurement equipment, treatment and diagnostic equipment, dose calculation and patient dosimetry systems); Support (management of the human and material resources, relationships with maintenance services, data processing department, primary and secondary standards dosimetry laboratories, etc.). (3) Procedures manual: details the procedures of the different processes and their performance indicators, establishing periodicity, tolerance and action levels. (4) Worksheet manual, which includes all the forms used in the daily activity. The developed system will make the integration of the MPD in the Hospital global quality system easier, but it s worth noting that a lot of dedication of the MPD staff in establishing and executing the program will be needed. 2

3 1. Objective and scope of the quality system The objective is to establish a quality management structure looking for optimal performance of activities of the Servei de Física i Protecció Radiológica, which is the MPD of the Hospital Universitari Vall d Hebron in Barcelona. The system is focused on improving the performance of the MPD and achieving success in the work under its responsibility, regarding the physical criteria of patient radiation protection [1] in three different scenarios: the Radiotherapy, Nuclear Medicine and Radiology departments of the Hospital. The system will guarantee the quality control of implied activities and their results. The rest of the processes that form the whole MPD work, as well as their interdependence, must also be established to ensure maximum quality and control of processes that make up this particular area. Maintenance, improvement and implementation of the QMS are responsibility of the Hospital management and the Medical Physics head of department. Responsibility of this last one includes resources and procedures management, measurement and analysis. 2. The ISO 9001:2000 standard The QMS structure has been implemented in accordance with ISO 9001:2000 standard requirements (from the ISO 9000 family of standards). This standard is based on eight quality management principles [2], focused on improving the effectiveness of an organization and achieving success in its work. Its essential requirements are structured into five main chapters [3]: Quality management system Management responsibility Resource management Product realization Measurement, analysis and improvement The ISO 9001 norm has an contractual application, regulating quality relationship between medical physics and clinical departments, warranting the observance of specifications done in the tasks requested. Requirements include evaluation of the effectiveness of training and other taken actions, provision of relevant information, internal and external communication, infrastructure, and work environment. Emphasis is placed on top management commitment to make necessary resources available. The standard promote the adoption of a process approach when developing, implementing and improving a QMS. This is a main key. The organization is structured as a collection of processes each one composed by a series of activities that in their turn imply a certain group of particular procedures (Fig. 1). ISO 9001 requires also a continual improvement, defined in a complete cycle to improve the effectiveness of the QMS (Fig. 2). FIG. 1. Organizational structure. 3

4 FIG. 2. QMS continual improvement cycle. A thorough documentation of all the procedures is mandatory and the final measure of system performance is customer satisfaction. 3. General requirements of the QMS According to the ISO 9001:2000 standard, the following steps have been fulfilled: Identification of the involved processes and their implementation through the organization. Establishment of its sequence and interactions. Determination of methods and criteria to ensure an effective running and control of the processes. Setting up of a system that guarantees the availability of the necessary information to support the operation and monitoring of the processes. Execution of measurements, process monitoring and process analysis techniques. Implementation of the necessary actions to achieve the planed goals and the continual improvement. 4. Specific normative references, terms and definitions Quality control in the different areas and radiation protection requirements are established in accordance with Spanish regulations related to the use of ionising radiation in diagnostic and treatment of diseases [4]. Terms and definitions used regarding the MPD activity are also explained in those regulations. QMS terms and definitions used are in accordance with the ISO norm [5]. 5. The structure of the QMS documentation The designed quality system involves the pyramidal documentation structure showed in Fig. 3, with the following four manuals: 1. The Quality Manual, showing the content, structure and policy of the quality system. 2. The Processes Manual, that contains and explains the different managed processes, separated in three groups according to their scope: 4

5 Strategic Processes (PE) Key / Operative Processes (PC) Support Processes (PS) 3. The Procedures Manual, a detailed description of all the procedures carried out by the MPD. 4. The Records Manual, comprising all forms and records used in the everyday activity. It includes different working sheets (HT), describing steps to be followed in each particular operation. Besides that, documents have been provided with a code system (Fig. 3) to be properly identified and correlated. It is separated in two principal types: 1. Identification digits, to identify the kind of document. 2. Correlation digits, to provide the documentation structure with the necessary links between its different levels. FIG. 3. QMS documentation system There exists a continuous updating of the documentation system that traces all its modifications and revisions. Its responsibility falls on the MPD head of department, which is also in charge of the distribution of the updated copies to the different people involved. 6. Organizational items of the quality system In order to a correct implementation of the system, the following items have been defined: 1. Organization chart of the MPD. 2. Mission, objectives and strategy of the MPD. 3. Tasks and responsibilities of the head of department and the rest of the specialized MPD staff. 4. Tasks and responsibilities of other technician, administrative and auxiliary staff. 5. Quality records and its storage and control. 7. Strategic processes of the QMS These are general processes, providing guidelines to the MPD organization and key processes in order to achieve the mission and perspective of the MPD. The main processes are: - PE1 Definition/Communication of the annual objectives and the MPD strategy - PE2 Management of tasks and responsibilities - PE3 Management of the quality system (documentation control, records, incidences, client satisfaction, etc.) - PE4 Research and development of new measurement techniques and new treatment modalities - PE5 Training in medical physics. 5

6 8. Key / operative processes of the QMS These are MPD specific processes, having a direct impact in their daily activity. Their results are entries to the MPD internal clients, i.e. the clinical areas of Radiotherapy (RT), Nuclear Medicine (MN) and Radiology (RD). The following is a list of these processes and its codes: - PC1RT QA program of MPD measurement equipment in Radiation Therapy - PC2RT QA program of Radiation Therapy units and sources - PC3RT QA program of radiation treatment planning system (TPS) - PC4RT Patient dosimetry in Radiotherapy - PC1RX QA program of MPD measurement equipment in Radiology - PC2RX QA program of Radiology conventional/interventional units - PC3RX QA program of dose calculation systems - PC4RX Patient dose assessment in conventional/interventional Radiology - PC1MN QA program of the MPD measurement equipment in Nuclear Medicine - PC2MN QA program of the Nuclear Medicine diagnostic units and therapeutic sources - PC3MN QA program of MN specific calculation systems - PC4MN Patient dose assessment in Nuclear Medicine therapy and diagnostic methods Principal procedures of these processes can be grouped as follows: - PR1: Acceptance tests - PR2: Initial reference system - PR3: Quality control normative procedures - PR4: Management of clinical department notifications of equipment failure - PR5: Patient dose assessment 8.1. Patient dose assessment procedures This is a group of procedures that contains three specific sub-procedures: Methods for patient dosimetry in Radiotherapy Methods for patient dose assessment in conventional/interventional Radiology Methods for patient dose assessment in therapeutic/diagnostic Nuclear Medicine As cited above, the management system defines the corresponding set of working sheets describing the steps to be followed in each particular operation. 9. Support processes of the QMS These processes are not directly linked to the flow of the daily activity, but are necessary to ensure a perfect implementation of the key processes (management of human and material resources, relation with maintenance services, data processing department, relation with PSDL or SSDL laboratories etc.). They involve other departments and external companies that help the MPD in its work.. The MPD has responsibility, regarding communication and recording of their activities, on the following support processes: - PS1 Maintenance of MPD measurement s equipment - PS2 Calibration of measurement s equipment - PS3 Maintenance of therapeutic and diagnostic radiation units The following list shows support processes under the responsibility of the hospital organization: - PS4 Maintenance of premises - PS5 Management of MPD purchases system - PS6 Data processing department support 6

7 - PS7 Human resources management - PS8 Cleaning / waste materials management - PS9 Material resources management 10. Map of the QMS processes The architecture of the QMS system of processes is shown in Fig. 4. This diagram presents the different kinds of processes, along with its link structure. Strategic Processes PE1 MPD strategy and annual objectives PE2 Management of tasks and responsibilities PE3 Management of the quality system PE4 R+D of new measurement techniques and new treatments PE5 Training in medical physics Medical Departments (RT, RD, MN) Key / Operative Processes PC4xx Patient dosimetry and dose assessment Medical Departments (RT, RD, MN) Equipment suppliers PC1xx QA of measurement s equipment PC2xx QA of Treatment Units and Radiation Systems PC3xx QA of TPS and Data Processing Systems Support Processes PS1 Maintenance of the MPD equipment PS2 Calibration of measurement equipment PS3 Maintenance of the Therapeutic and Diagnostic Radiation Units PS4 Maintenance of premises PS5 Management of the purchases system PS6 Data processing department support PS7 Human resources management PS8 Cleaning / waste materials management PS9 Material resources management FIG. 4. Architecture process mapping. xx stands for RT, RD, MN Processes are to be detailed in the corresponding section of the processes manual. This manual includes references to the related procedures and worksheets. 11. Quality indicators They are numbers, indexes, etc. to monitor, measure and analize every process, in order to make possible its continual improvement. They are also called Key Performance Indicators (KPI) in ISO 9001:2000 terminology. Each one is associated to a specific process, and for every process the adequate collection of KPI must be defined, for they serve to measure the fulfilment of the quality objectives. Variation from its expected values usually triggers posterior analysis and actions. In the field of the MPD work they usually are physical magnitudes, parameters, factors, etc. The QMS considers KPI s having direct influence (Operative/Key processes) in the usual QA program, and those that in an indirect way will allow an improved quality for patient treatment and diagnosis. 7

8 They are closely linked with the usual physics quality indicators of the international QA programs in Radiotherapy, Nuclear Medicine and Radiology. 12. Parts involved in the QMS In order to define and assign responsibilities in the QMS, it is mandatory to establish clear links between each process and the hospital organization chart. The following is a list of implied parts in the QMS: 1. Hospital management / direction 2. Hospital QMS commission 3. Radiotherapy Clinical Unit 4. Radiology Clinical Unit 5. Nuclear Medicine Clinical Unit 6. MPD head of department 7. Medical physicists 8. Technical and auxiliary staff 9. Hospital General Services 10. Official Metrology Laboratories 11. Suppliers 12. Maintenance Services A cross-reference table that states responsibilities and involvement of each implied part in every process has been established. Types and levels of assigned responsibilities and involvement are distributed as follows: R: Final responsible for the process. A: Process analysis and procedures development. E: Process execution. C: Consulted to establish the process design and modification. I: Informed of process modification. G: Source that implies the necessity of the process and its periodic execution. RL: Responsible of the assigned normative attributions. 13. Conclusion In this work, the Medical Physics patient radiation protection management system is viewed as a key subset included in the general structure of a QMS applied to the MPD of the hospital. The application of the ISO 9001:2000 norms to this structure guarantees both, the efficient managing of the MPD processes and their easy integration into the overall hospital quality system. Moreover, it makes easy its understanding by external professionals and auditors. Processes implied in the system have been defined, along with its type and hierarchy, its links, and its main procedures. The need of a systematic documentation in each level of the system and the involvement of top management has also been emphasized. Despite being established in our own hospital, this system is general enough to be easily adapted to any MPD, with small changes. As a final word of caution, it must be taken into account the increased amount of time and effort of the MPD staff in establishing and executing the QMS. An understaffed MPD would therefore affect directly the system feasibility. 8

9 REFERENCES 1. European Commission. Council Directive 97/43/EURATOM of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure and repealing Directive 84/466 Euratom. Official Journal of the European Communities 1997;L 180: International Organization for Standardization, Quality Management Principles, ISO Technical Committee ISO/TC176, ISO Central Secretariat, Geneva (2000) 3. International Organization for Standardization, Quality Management systems - Requirements, ISO Technical Committee ISO/TC176, ISO number: 9001, ISO Central Secretariat, Geneva (2000) 4. Spanish Royal Decrees. In: State Official Bulletin (BOE) Real Decreto 1841/1997 de 5 de diciembre, por el que se establecen los Criterios de Calidad en Medicina Nuclear, BOE 19/12/1997. Real Decreto 1566/1998 de 17 de julio, por el que se establecen los Criterios de Calidad en Radioterapia, BOE 28/08/1998. Real Decreto 1976/1999 de 23 de diciembre por el que se establecen los Criterios de Calidad en Radiodiagnóstico, BOE 29/12/1999. Real Decreto 1132/1990 de 14 de septiembre por el que se establecen medidas fundamentales de protección radiológica de las personas sometidas a exámenes y tratamientos médicos, BOE 18/09/1990. Real Decreto 1891/1991, de 30 de diciembre, que tiene por objeto regular la utilización de equipos e instalaciones de rayos X con fines de diagnóstico médico, BOE 03/01/1992.Real Decreto 783/2001.de 6 de julio, por el que se aprueba el Reglamento de Protección Sanitaria contra radiaciones ionizantes, BOE 26/07/ International Organization for Standardization, ISO 9000: Quality management systems Fundamentals and vocabulary, ISO Technical Committee ISO/TC176, ISO Central Secretariat, Geneva (2000) 9