09. Quality assurance (66 KB)

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09. Quality assurance (66 KB)

  1. 1. IAEA RADIATION PROTECTION IN NUCLEAR MEDICINE PART 9. QUALITY ASSURANCE 1. GENERAL PRINCIPLES Quality assurance (QA) is defined as: ”all those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality” (ISO) According to the BSS (2.29): Quality assurance programmes shall be established that provide, as appropriate: a) adequate assurance that the specified requirements relating to protection and safety are satisfied; b) quality control mechanisms and procedures for reviewing and assessing the overall effectiveness of protection and safety. And for medical exposure: II.22. Registrants and licensees shall establish a comprehensive quality assurance programme for medical exposures with the participation of appropriate qualified experts in the relevant fields, such as radiophysics or radiopharmacy, taking into account the principles established by the WHO and the PAHO. According to WHO three main objectives should be envisaged when quality assurance programmes are considered: 1. improvement in the quality of the diagnostic information; 2. use of a minimum amount of radionuclide activity to ensure the production of the desired diagnostic information; 3. effective use of available resources. Quality is basically to fulfil the expectations the referring physicians and the patients have on the nuclear medicine service. QA is a management tool aimed to ensure that every examination or treatment is performed with a high medical quality and with respect to the general principles of radiation protection (justification and optimisation). This should be achieved by using accepted clinical protocols, by having well trained personnel and by using properly selected and functioning instrumentation. In more detail a QA programme in nuclear medicine should include: Procedure (i.e patient history and signs, diagnostic question, appropriateness of investigation, contraindications) Planning of procedure (i.e reliable administrative procedures, patient information, patient preparation) Clinical procedure (i.e approved suppliers and materials, storage, preparation, clinical environment, patient handling and preparation, equipment performance, acquisition protocols, waste disposal) Training and experience of nuclear medicine specialists, physicists and technologists and others involved Data analysis (i.e processing protocol, equipment performance, data accuracy and integrity) Report (i.e. data, image review, results and further advice) General outcomes (i.e clinical outcome, radiation dose, patient satisfaction, referring physician satisfaction) Audit A quality control (QC) programme should be introduced and aimed to regularly check the outcome of the different components of the QA programme. 2. ORGANIZATION At a national level it is advisable that a working group in quality assurance be organized and sponsored by national authorities and professional societies. This 1
  2. 2. IAEA RADIATION PROTECTION IN NUCLEAR MEDICINE PART 9. QUALITY ASSURANCE group can assist with the practical implementation of a QA programme at the local level and provide guidelines and regulations, which are generated for national authorities and international bodies. The working group should also initiate national interlaboratory comparison programmes and support participation in such programmes organized by international bodies. In the hospital it is common to put quality assurance as a part of the radiation protection programme or the opposite to put the radiation protection programme as a part of a more general quality assurance programme for the hospital. Regardless of the organization, it is important that radiation protection is an integrated part of a system of quality assurance. It is advisable that the department establishes a group that is actively working with quality assurance issues. Such a group should have a nuclear medicine specialist, a medical physicist, the chief technician, a pharmacist and an engineer as members. The group should meet regularly and review the different components of QA, such as administrative routines, working procedures, procedure manuals, follow up of examinations and treatments, quality control of equipment, routines for purchasing of instruments etc. 3. ADMINISTRATIVE ROUTINES An appropriate administrative routine is an important part of a quality assurance programme. This includes patient identification, patient information, type of study and justification of request, selection of examination protocol, diagnostic report and records. Patient identification should follow the hospital routines. A proper system of identification will prevent examination or treatment of the wrong patient. It is recommended that a procedure manual should be made available for each type of examination. This manual should be reviewed at least annually and any changes to the original should be dated and made known to all staff. The records to be kept include: Authorization certificate and documentation supporting the corresponding application, and also any correspondence between the licensee and Regulatory Authority; • Name of the person authorized and responsible for the radiation protection programme; • Individual doses (current and prior work history); • Results of area surveys; • Equipment and instrument QC tests and calibration; • Inventory of unsealed and sealed sources; • Incident and accident investigation reports; • Audits and reviews of the radiation safety programme; • Installation, maintenance and repair work; • Facility modification; • Training provided (initial and continuing), including the following information: Name of the person(s) who delivered the instruction or training; Name of the person(s) who received the instruction or training; Date and duration of the instruction or training; List of the topics addressed; and Copy of the certificates of training. • Evidence of health surveillance of workers; • Waste disposal; • Transportation: Package surveys; 2
  3. 3. IAEA RADIATION PROTECTION IN NUCLEAR MEDICINE PART 9. QUALITY ASSURANCE Package documentation; • Transfer/receipt documents; and Details of shipments dispatched • Patient records; and • Patient discharge surveys for patients receiving radionuclide therapy. 4. OCCUPATIONAL AND MEDICAL EXPOSURE An ill patient needs complete confidence in the care he/she will receive and must be confident that diagnostic procedures and treatments are performed in the best way and that his/her well-being is always foremost. The patient may hardly know how to judge the quality of the care received but must always be confident that it is of the highest quality available. Hence the professionals who are responsible for the patient's care need to ensure that such high quality care is received. In the medical use of ionizing radiation it is important that the protection requirements are regarded as an integrated part of the overall quality. As an example, a nuclear medicine examination performed under optimized conditions resulting in a correct diagnosis with as low exposure of the patient as possible must be regarded as having a higher quality than an examination where the same diagnosis is achieved using a higher exposure to the patient. High quality requires a combination of appropriate attitudes and selected technical factors. A properly trained staff will be motivated to achieve a high quality of work and adopt a safety culture. This will have a positive effect on the occupational and medical exposure as well as the care of the patient. 5. INSTRUMENTATION Quality assurance is not only important for maintaining high standards of clinical practice in the use of ionizing radiation in medical care but also for maintaining high performance of equipment. In each department there should be a continuous review process to monitor clinical and equipment performance in accordance with national and international standards. There should also be routines and a policy for purchasing equipment. The department’s quality assurance programme for equipment should include acceptance tests carried out initially to provide a baseline of data, and subsequent routine tests carried out at appropriate frequencies to monitor the constancy of various aspects of performance. The acceptance test consists of a quality control (QC) programme to assess whether the equipment fulfills the specifications or not. It should be made in cooperation with the manufacturer, who partially may take an active part in the control programme. A qualified expert, who, in some cases, may be temporarily engaged just for that purpose, should perform the acceptance testing. The results of the acceptance tests should be recorded as a base against which to compare future tests. Routine quality control measurements should be made at regular intervals, and also after any major change of components, updating by the manufacturer, or repairs. Since it is essential to maintain long-term overall stability of performance, these measurements must be carefully specified, performed, recorded, and evaluated. Minor routine quality control should also be performed at shorter intervals. The measurements should be quite simple so that the technical personnel in the department can make them. The results should be recorded and continuously analyzed by an experienced and competent person. 3
  4. 4. IAEA RADIATION PROTECTION IN NUCLEAR MEDICINE PART 9. QUALITY ASSURANCE If the result does not differ from the reference base, then the equipment can continue to be used. Otherwise necessary repairs or corrections should be undertaken before the equipment is used again. Equipment, which does not work properly, should not be used in diagnosis and therapy. The communication between the staff handling the equipment and the physician responsible for the safety of the patient should be simple and effective. Anyone who notices that the equipment does not work properly should immediately report this to the head of the department or directly to the person responsible for the quality control programme, who should then initiate corrective actions. An open attitude is very important. 6. EDUCATION AND TRAINING The competency and knowledge of the individual who requests or performs a nuclear medicine procedure is most important in ensuring high quality services. Education, training and curriculum requirements, as they apply to the use of ionizing radiation, vary according to category of personnel. Applicable standards for all types of radiological staff must therefore be continuously reviewed. WHO and ICRP stress the importance of developing good clinical judgment in the use of ionizing radiation, which should start during the education and training of medical and dental students. This training should extend into postgraduate and residency programmes. Clearly the education and training appropriate for the various types of professionals involved in nuclear medicine will differ. It is therefore important to tailor the training and education programme to meet the anticipated needs of the individual's function. Generally speaking, the basic education should always include the physical and technical aspects of radiation, as well as the fundamentals of radiation physics and radiobiology. Theoretical instruction should be accompanied by practical demonstrations. For those persons who professionally and regularly use ionizing radiation, the basic education on radiation protection should be an integrated part of their general education in the profession. For all personnel engaged in the use of equipment it is essential that the basic education and training is supplemented with training on local equipment. As a guide there must always be a user manual available and this should also include relevant information on radiation protection. Furthermore, if auxiliary personnel are to be employed in any procedures connected with the use of radiation, the supervisor must be competent enough to instruct them in the proper procedures and also must assume full responsibility for the work performed. In many countries every user of radionuclides must attend and pass a prescribed course in radiation protection and in the biological effects of ionizing radiation and the individual must be properly licensed to use a radiation source. It is highly desirable that responsible professionals undergo such a course, even where it is not legally required. In some countries, radiation protection legislation requires continuing education after the successful completion of an initial training programme, the intention being to ensure that all individuals concerned with ionizing radiation have up-to-date knowledge. In some places special training courses may have to be organized for individuals who are already professionally qualified but not trained in radiation protection. Certificates of attendance may need to be issued to demonstrate adequate training. 7. REFERENCES 1. INTERNATIONAL ATOMIC ENERGY AGENCY. International Basic Safety 4
  5. 5. IAEA RADIATION PROTECTION IN NUCLEAR MEDICINE PART 9. QUALITY ASSURANCE Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources. Safety Series No.115, IAEA, Vienna (1996). 2. INTERNATIONAL ATOMIC ENERGY AGENCY. Model Regulations on Radiation Safety in Nuclear Medicine. (in preparation). 3. WORLD HEALTH ORGANIZATION and INTERNATIONAL ATOMIC ENERGY AGENCY. Manual on Radiation Protection in Hospital and General Practice. Vol. 4. Nuclear medicine (in press) 4. PAN AMERICAN HEALTH ORGANIZATION. Organization, development, quality control, and radiation protection in radiology services. PAHO Washington D.C., (1997). 5. WORLD HEALTH ORGANIZATION. Quality Assurance in nuclear medicine. A guide prepared following a workshop in Heidelberg, Germany. WHO, Geneva, (1982) 6. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. Quality management and quality assurance standards: Guidelines for selection and use (ISO 9000-1987), 1987 7. INSTITUTE OF PHYSICAL SCIENCES IN MEDICINE. Quality standards in nuclear medicine, Smith A.H., Hart G.C. editors. IPSM, York, 1992 (IPSM Report No. 65). 5
  6. 6. IAEA RADIATION PROTECTION IN NUCLEAR MEDICINE PART 9. QUALITY ASSURANCE Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources. Safety Series No.115, IAEA, Vienna (1996). 2. INTERNATIONAL ATOMIC ENERGY AGENCY. Model Regulations on Radiation Safety in Nuclear Medicine. (in preparation). 3. WORLD HEALTH ORGANIZATION and INTERNATIONAL ATOMIC ENERGY AGENCY. Manual on Radiation Protection in Hospital and General Practice. Vol. 4. Nuclear medicine (in press) 4. PAN AMERICAN HEALTH ORGANIZATION. Organization, development, quality control, and radiation protection in radiology services. PAHO Washington D.C., (1997). 5. WORLD HEALTH ORGANIZATION. Quality Assurance in nuclear medicine. A guide prepared following a workshop in Heidelberg, Germany. WHO, Geneva, (1982) 6. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. Quality management and quality assurance standards: Guidelines for selection and use (ISO 9000-1987), 1987 7. INSTITUTE OF PHYSICAL SCIENCES IN MEDICINE. Quality standards in nuclear medicine, Smith A.H., Hart G.C. editors. IPSM, York, 1992 (IPSM Report No. 65). 5

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