IAEA Training Material Radiation Protection in Nuclear Medicine Part 9 Quality Assurance Objective To become familiar with the concepts of Quality Assurance in radiation protection in nuclear medicine and procedures for reviewing and assessing the overall effectiveness of radiation protection Nuclear Medicine Part 9. Quality Assurance 2 Contents Nuclear Medicine General principles Organization of QA Administrative routines Occupational and Medical exposure Instrumentation Education and training Part 9. Quality Assurance 3 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 9. Quality Assurance Module 9.1. General Principles QA Programme Objectives • Improvement in the quality of the diagnostic information. * Use of minimum amount of radionuclide activity to ensure the production of the desired diagnostic information. * Effective use of available resources Nuclear Medicine Part 9. Quality Assurance 5 Quality Assurance BSS: Interim Edition “3.169. Registrants and licensees, in applying the requirements of these Standards in respect of management systems, shall establish a comprehensive programme of quality assurance for medical exposures with the active participation of medical physicists, radiological medical practitioners, medical radiation technologists and, for complex nuclear medicine facilities, radiopharmacists and radiochemists, and in conjunction with other health professionals as appropriate. Principles established by the World Health Organization, the Pan American Health Organization and relevant professional bodies shall be taken into account.” Nuclear Medicine Part 9. Quality Assurance 6 Quality Assurance BSS: Interim Edition “3.170 Registrants and licensees shall ensure that programmes of quality assurance for medical exposure include, as appropriate to the medical radiation facility” Nuclear Medicine Part 9. Quality Assurance 7 Quality Assurance contd.. “(a) Measurements of the physical parameters of medical radiological equipment made by, or under the supervision of, a medical physicist: (i) At the time of acceptance and commissioning of the equipment prior to its clinical use on patients; (ii) Periodically thereafter; (iii) After any major maintenance procedure that could affect protection and safety of patients; (iv) After any installation of new software or modification of existing software that could affect protection and safety of patients; (b) Implementation of corrective actions if measured values of the physical parameters mentioned in (a) are outside established tolerance limits; (c) Verification of the appropriate physical and clinical factors used in radiological procedures; (d) Maintaining records of relevant procedures and results; (e) Periodic checks of the calibration and conditions of operation of dosimetry equipment and monitoring equipment.” Nuclear Medicine Part 9. Quality Assurance 8 Quality Assurance (Definition) “all those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality” (ISO) Nuclear Medicine Part 9. Quality Assurance 9 QA and QC Quality Assurance is the overall process which is supported by Quality Control activities Quality Control describes the actual mechanisms and procedures by which one can assure quality Nuclear Medicine Part 9. Quality Assurance 10 Quality Quality of a practice is to fulfil the expectations and demands from: Clinician Patient Yourself Nuclear Medicine Part 9. Quality Assurance 11 Quality Assurance OVERALL QUALITY Diagnostics Therapy Nuclear Medicine Protection Safety Part 9. Quality Assurance 12 Quality Define Objectives How many times should the nurse be allowed to drop the child? Nuclear Medicine What is an acceptable sensitivity and specificity? Part 9. Quality Assurance 13 Nuclear Medicine Service facilities patient care waiting time staff reporting competence experience optimisation radiopharmaceuticals methods examination technique instrumentation etc etc Nuclear Medicine Primary service Secondary service Part 9. Quality Assurance Nuclear medicine examination or treatment 14 Quality Assessment Communication with the client (patient, clinician). Expectations Acceptable level Reality Nuclear Medicine Part 9. Quality Assurance 15 Nuclear Medicine Diagnosis and Therapy with Unsealed Sources Clinical problem Radiopharmaceutical Nuclear Medicine Part 9. Quality Assurance Instrumentation 16 Quality Assurance Programme A quality assurance programme in nuclear medicine should ideally 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 Nuclear Medicine Part 9. Quality Assurance 17 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 9. Quality Assurance Module 9.2. Organization Organizations International bodies Recommendations. Interlaboratory comparison programmes. Education and training. National organizations National guidelines, codes of practice etc. Interlaboratory comparison programmes. Education and training. Industry Assistance in acceptance tests. Documentation. Training. Maintenance. Professional associations Supporting QA-programmes Establishing working groups Education and training Nuclear Medicine Part 9. Quality Assurance 19 Local Organization Hospital manager (licensee) QA committee QA-group nuclear medicine (chief technician, physicist, physician, pharmacist) Nuclear Medicine Part 9. Quality Assurance 20 QA Committee Membership Must represent the many disciplines within the department Should be chaired by the Head of Department As a minimum must include a medical doctor, a physicist, a technologist and an engineer responsible for service and maintenance Must be appointed and supported by senior management Must have sufficient depth of experience to understand the implications of the process Must have the authority and access to the resources to instigate and carry out the QA process Nuclear Medicine Part 9. Quality Assurance 21 Quality Assurance Committee Should ‘represent’ the department Should be ‘visible’ AND accessible to staff Oversees the entire Quality Assurance program Writes policies to ensure the quality of patient care Assists staff in tailoring the program to meet the needs of the Department (using published reports as a guide) Monitor and audit the program to ensure that each component is being performed and documented Nuclear Medicine Part 9. Quality Assurance 22 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 9. Quality Assurance Module 9.3. Administrative Routines Administrative Routines Nuclear Medicine Request Patient id and care Examination Method Computer evaluation Diagnostic report Part 9. Quality Assurance 24 Request It is the responsibility of the nuclear medicine specialist that the study requested by the referring physician is justified. Special attention must be paid to studies requested for children and pregnant women. Are there alternative methods e.g. ultrasound, MRI etc.? Communication, on a regular basis, between the referring clinician and the nuclear medicine specialist is very important. Nuclear Medicine Part 9. Quality Assurance 25 Patient • Identification of the patient • Information about the examination including premedications • Waiting for the examination A fully informed and motivated patient is the basis for a successful examination as well as a staff well educated in care of the patient. Nuclear Medicine Part 9. Quality Assurance 26 Young Patients ..should also be informed and motivated Nuclear Medicine Part 9. Quality Assurance 27 Patient Movement Nuclear Medicine Part 9. Quality Assurance 28 Patient Movement moving moving moving Nuclear Medicine Part 9. Quality Assurance 29 Policies and Procedures Manual Reviewed (typically) yearly This manual contains clear and concise statements of all the policies and procedures carried out in the department Updated as procedures change Nuclear Medicine Policies and Procedures Manual Part 9. Quality Assurance 30 Policies and Procedures Manual As a minimum, sections should exist for Administrative procedures Clinical procedures Radiation safety Nuclear Medicine Part 9. Quality Assurance 31 Policies and Procedures Manual It must be “signed off” by the Head of Department and appropriate section heads It is important that all staff have “ownership” to the manual - it should reflect the opinions of all and be agreed to by all A list of all copies of the Manual and their location must be kept to ensure that each copy is updated Nuclear Medicine Part 9. Quality Assurance 32 Methods Methods should be in accordance with accepted practices Study name: Preparation of patient: Radiopharmaceutical: Route of administration: Activity: Type of examination: Views: Scanning speed: Collimator: Window setting: Positioning of patient: Presentation of result: Nuclear Medicine Bone scan Empty bladder Tc99m-MDP IV injection 400 MBq Whole body scan AP, PA 10 cm/minute Scanning 140+/-20% keV Supine Images in BW on film. Original and filtered. Part 9. Quality Assurance 33 Methods Static? Tomographic? Dynamic? Nuclear Medicine Part 9. Quality Assurance 34 Methods Tl-201 25 mSv Nuclear Medicine Tc-99m 8 mSv Part 9. Quality Assurance 35 Quality Assurance Computer Evaluation Efficient use of computers can increase the sensitivity and specificity of an examination. •software based on published and clinically tested methods •well documented algorithms •user manuals •training •software phantoms Nuclear Medicine Part 9. Quality Assurance 36 QC Application Programmes Analysis of the programme code Phantom studies Simulated examinations Reference data (normal material) Clinical evaluation Nuclear Medicine Part 9. Quality Assurance 37 Bone Scan Phantom Nuclear Medicine Part 9. Quality Assurance 38 Thyroid Phantom Nuclear Medicine Part 9. Quality Assurance 39 Nuclear Medicine Part 9. Quality Assurance 40 Diagnostic Report Patient identification Date and type of study Radiopharmaceutical and activity Study results - e.g. a graph or a series of images Objective description of findings Diagnostic conclusion and recommendations Avoid adjectives like ’possible’, ’probable’, ’likely’ etc. They can never be interpretated by the referring physician. The diagnostic conclusion should be more quantitative e.g. by using a probability statement. Nuclear Medicine Part 9. Quality Assurance 41 Quality Assurance Method Patient follow-up. Correlation with other available surgical, pathological, clinical and anatomic information. False positives? False negatives? Nuclear Medicine Part 9. Quality Assurance 42 The final judge of any analytical method is a clinical audit: the correctness and impact of the decisions made with respect to any method and process. Society of Nuclear Medicine Procedure Guideline for General Imaging Nuclear Medicine Part 9. Quality Assurance 43 Records •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 RPP; •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; Nuclear Medicine Part 9. Quality Assurance 44 Records (contd..) •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 documentation; Package surveys; Transfer/receipt documents; and Details of shipments dispatched •Patient records; and •Patient discharge surveys for patients receiving radionuclide therapy. Nuclear Medicine Part 9. Quality Assurance 45 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 9. Quality Assurance Module 9.4. Occupational and Medical Exposure Examination Nuclear Medicine Request Patient id and care Examination Method Computer Evaluation Diagnostic report Part 9. Quality Assurance 47 The patient shall always be confident that a nuclear medicine examination and therapy is performed correctly and with highest possible quality regarding both diagnostics/therapy and safety. Nuclear Medicine Part 9. Quality Assurance 48 Medical Exposure Choice of examination Determination of technical parameters Optimization of administered activity Methods of reducing the absorbed dose Quality control of equipment and radiopharmaceutical Quality assurance of methods Safe routines to avoid misadministration Nuclear Medicine Part 9. Quality Assurance 49 Factors Affecting Medical and Occupational Exposure Receipt and storage Preparation Detection (QC equipment) Administration Contamination Radioactive waste Nuclear Medicine Part 9. Quality Assurance 50 Quality Control Radiopharmaceuticals • Radionuclide purity (other radionuclides?) • Radiochemical purity (labelling efficiency) • Chemical purity (toxic substances?) • Sterility • Absence of pyrogens Responsibility of the approved manufacturer and supplier Nuclear Medicine Part 9. Quality Assurance 51 Quality Assurance Radiopharmaceuticals • Quality control of radiopharmaceuticals. • Written and trained procedures in preparation and safe handling of radiopharmaceuticals • Use of a unique code which guarantee the ability to trace the origin of all components in the preparation. • Records of radionuclides, kits etc. • Labeling of vials and syringes. • Measurement of activity. Nuclear Medicine Part 9. Quality Assurance 52 Preparation of Radiopharmaceuticals • Use a transparent vial shield • Put the kit in the shield • Add Tc99m and finish the preparation • Measure the activity • Write the label and put it on the vial shield • Check the kit and the label on the vial shield. Same radiopharmaceutical? Nuclear Medicine Part 9. Quality Assurance Tc99m-MDP 2237 447 1997-09-28 5 SC 7.40 53 Dispensing Radiopharmaceuticals • Check kit and vial shield label Correct radiopharmaceutical? • Draw the required volume • Measure the activity • Write the label and put it on the syringe shield Nuclear Medicine Part 9. Quality Assurance Tc99m-MDP 400 MBq 400928-3336 1997-09-28 07.45 SC 54 Injecting Radiopharmaceuticals • Patient name? • Patient identification number? • Pregnant? • Breastfeeding? • Check the request form • Check the label of the syringe. Correct radiopharmaceutical for the required examination? Correct activity? • Inject! Nuclear Medicine Part 9. Quality Assurance 55 The worker should always feel confident that he/she has the necessary training in order to perform his/her duty. The worker should feel that he/she gets the necessary support from the licensee in matters concerning working situation and safety. Nuclear Medicine Part 9. Quality Assurance 56 Factors Affecting Quality •Design of facility •Safe receipt and storage of unsealed sources •Safe handling of unsealed sources •Management of radioactive waste •Safety equipment •Personal monitoring •Health surveillance •Workplace monitoring •Emergency procedures •Local rules •Training and experience of staff Nuclear Medicine Part 9. Quality Assurance 57 Education of Staff Correct use of Equipment Close Nuclear Medicine 15 cm Part 9. Quality Assurance Wrong setting of energy window 58 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 9. Quality Assurance Module 9.5. Instrumentation How to get a new Gamma camera? Nuclear Medicine Part 9. Quality Assurance 60 Purchase Group •Nuclear medicine specialist •Nuclear medicine technologist •Medical physicist •Medical engineer •Person from the hospital administration Nuclear Medicine Part 9. Quality Assurance 61 How to open the safe? Careful analysis of the need and state the reasons for the purchase of the gamma camera •Establishment of a nuclear medicine service •Increased volume of patients •The technical performance is not good enough for new methods •No spare parts available •Unrepairable Nuclear Medicine Part 9. Quality Assurance 62 How Many Cameras? As an example, let us assume that in a certain region of a country having a stable population of 150000 there are plans to establish a nuclear medicine facility. The mean number of examinations in the country is 15 per 1000 population and year but the new department should be designed to fulfil a future need of 20 per 1000 population, which means that the total number of examinations will be 3000 per year or 60 per week Nuclear Medicine Part 9. Quality Assurance 63 Basic Calculation Type of examination Bone Lungs Liver CBF Myocard Kidneys Thyroid Others Quality control Total Examinations per week 20 6 2 5 10 8 5 4 1 61 Time (h) per examination *) 1 0.5 0.8 1 2 0.75 0.5 1 3 Total time (h) per week 20 3 2 5 20 6 3 4 3 66 *) depends on the type of camera Nuclear Medicine Part 9. Quality Assurance 64 Result: Number of Cameras If we assume that the number of hours per week a gammacamera can be effectively used for patient examinations to be 28 (70% of 40) then the number of cameras should be 66/28=2.4. This figure should be further corrected by taking into account the time needed for regular maintenance of the equipment as well as unplanned stops due to different failures. Nuclear Medicine Part 9. Quality Assurance 65 End of step 1 Nuclear Medicine Part 9. Quality Assurance 66 Let the vendor define Your needs and make the selection Nuclear Medicine Write a tender document and distribute it to the vendors Part 9. Quality Assurance 67 Choice of Equipment •Type of procedure to be undertaken •Technical specifications •Manufacturer Spare parts Service and maintenance User and service manuals Education and training •Local user Service and maintenance Education and experience of staff Siting of the instrument •Ease, reliability and safety in operation •Cost Nuclear Medicine Part 9. Quality Assurance 68 Setting of Equipment •Sufficient space •Electrical power •Environmental factors (temperature, humidity, air pollution) •Structural shielding •Background radiation Nuclear Medicine Part 9. Quality Assurance 69 Maintenance Regular maintenance will result in: •Increased availability of equipment •Increased quality by better performance •Increased safety •Increased lifetime of equipment Nuclear Medicine Part 9. Quality Assurance 70 Maintenance Procedures should include consideration of the following: • Overall management of the maintenance programme. This is often provided by the medical physicist in co-operation with the RPO; • Measures to prevent the use of equipment during periods of maintenance; • Notification of the medical physicist whenever there is a repair, regardless of its importance. The physicist must assess whether any tests or measurements are to be made and whether the equipment is operating satisfactorily before it is used with patients; • Provision of a service contract covering preventative maintenance, particularly when equipment parts and expertise are provided by the manufacturer; • Maintenance of a service record during the lifetime of the equipment or for a duration specified by the Regulatory Authority. Nuclear Medicine Part 9. Quality Assurance 71 Equipment NEEDS FOR EFFICIENT USE • Well trained staff with access to manuals and other documentation. • Quality control program. • Regular maintenance. Nuclear Medicine Part 9. Quality Assurance 72 Purpose of Tendering The purpose of tendering for gamma cameras is to assess the best match between the requirements of the clinical department and the equipment available and not necessarily to buy the 'best camera’. Nuclear Medicine Part 9. Quality Assurance 73 What do we want? Hardware One, two or three detector heads? Round, square or rectangular detector? Crystal thickness? Collimators? Whole body scanning? PET-option? Transmission source? Nuclear Medicine Part 9. Quality Assurance 74 What do we want? Computer & software Acquisition modes? Application programmes? Network? Storage capacity? Backup? Nuclear Medicine Part 9. Quality Assurance 75 What do we want? More... Education and training Payment Warranty Reliability Service and maintenance List of users Manuals and other documentation Time of delivery Upgradability Quality control equipment Acceptance test Nuclear Medicine Part 9. Quality Assurance 76 The Tender Document Should Therefore Include: •System overview •Contact persons •Commercial specifications •Technical specifications •Data acquisition and processing •Electrical and mechanical safety (national regulations) •Education and training •Documentation •Service organization •Installation and acceptance testing Nuclear Medicine Part 9. Quality Assurance 77 What shall the vendor specify? Commercial specifications: •Price •Payment •Warranty •Liability insurance for installers •Right to refuse or remove equipment •Value of the old camera Nuclear Medicine Part 9. Quality Assurance 78 What shall the vendor specify? Hardware: •Crystal size and shape •PM-tubes •Gantry dimension and weight •Gantry movements, including autocontour •Electrical power requirements •Imaging table •Collimators and method of change •Shielding of detector •Operating console •Energy windows •Energy range •Safety features •Motion control Nuclear Medicine Part 9. Quality Assurance 79 What shall the vendor specify? Technical performance: •Linearity •Uniformity (different energies, different angles) •Energy resolution •Spatial resolution (intrinsic and system, planar and tomographic) •Count rate performance •Center of rotation •Multiple window spatial positioning •System sensitivity (planar and tomographic) •Point source sensitivity Nuclear Medicine Part 9. Quality Assurance 80 What shall the vendor specify? Computer system: •Acquisition modes •Basic application programmes •Clinical application programmes •Quality control programmes •DICOM-standard •Network and communication •Printers •Storage and backup of patient data Nuclear Medicine Part 9. Quality Assurance 81 What shall the vendor specify? …..and more: •User lists and site visits •Reliability (e.g. 95%) •Service response time and follow up •Training now and later •Service manuals •Upgradability •Delivery, setup and installation date •Floor loading, elevators and doors •Electrical requirements Nuclear Medicine Part 9. Quality Assurance 82 End of step 2 Distribute the tender documents to the vendors RELAX! Nuclear Medicine Part 9. Quality Assurance 83 The decision: Which camera fulfills our requirements? Nuclear Medicine Part 9. Quality Assurance 84 The Decision • Can the camera and the computer software be used efficiently for all types of intended examinations? • Are the technical specifications satisfactory? • Is the camera easy to handle? • Is the price reasonable? • Is the manufacturers service organization satisfactory? • Is the required training OK? Nuclear Medicine Part 9. Quality Assurance 85 Site Visits Nuclear Medicine Part 9. Quality Assurance 86 The Decision- End of step 3 Manufacturer 1 Manufacturer 2 + price + technical parameters - service - computer system + price - technical parameters + service - computer system We want that one!! Nuclear Medicine Part 9. Quality Assurance 87 Make a clear and detailed specification of the implementation agreement. • Which are the users responsibilities? • Which are the vendors responsibilities? • Which documents are valid? • Date of delivery? • Mode of payment? • Warranty? Sign the contract Make the installation Perform an acceptance test Nuclear Medicine Part 9. Quality Assurance 88 Quality Control Equipment Acceptance / reference testing. Measurements to assess whether instrumentation comply with its specifications. Manual available. Routine testing. Performed to maintain high quality and standard of the equipment. Analysis of results. Is the observed result significantly different from the reference testing? Is the observed result due to errors in the QC procedure? Records. Nuclear Medicine Part 9. Quality Assurance 89 Acceptance Tests X-ray installations 171 Passed 10 Passed after minor corrections 123 Not passed 38 (SSI 1992) Nuclear Medicine Part 9. Quality Assurance 90 QC Gamma Camera Uniformity Uniformity, tomography Spectrum display Energy resolution Sensitivity Pixel size Center of rotation Linearity Resolution Count losses Multiple window pos Total performance phantom P P P P P P P P P P P P Acceptance T T Daily T T T T T Weekly P P P P P P P P P P P P Yearly P: physicist, T: technician Nuclear Medicine Part 9. Quality Assurance 91 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 9. Quality Assurance Module 9.6. Education and Training How to achieve a high standard of safety in a hospital? •Safety culture •Support from the hospital management •Well educated staff •Local radiation protection organization •Quality assurance programme •Use of authorized services •Continuing education and training •Arrangements for individual monitoring and health surveillance •Records •Documented local rules and procedures Nuclear Medicine Part 9. Quality Assurance 93 Education and Training are essential for a radiation protection programme Use recommendations as stipulated in ICRP Publication 113 The relevant plan should include who, where and when shall be trained. Nuclear Medicine Part 9. Quality Assurance 94 Education and Training (BSS: Interim Edition) “2.21. The government shall ensure that requirements are established for: (a) education, training, qualification and competence in protection and safety of all persons engaged in activities relevant to protection and safety; (b) the formal recognition of qualified experts; (c) the competence of organizations that have responsibilities relating to protection and safety.” Nuclear Medicine Part 9. Quality Assurance 95 Education All staff in nuclear medicine must have appropriate education to perform their duties… For radiation protection purposes this affects particularly: Radiation Protection Officer Physician Qualified Expert (Medical Physicist) Nuclear Medicine Technician …. Nuclear Medicine Part 9. Quality Assurance 96 Education and Training Personnel shall be instructed in radiation protection before assuming duties: •the conditions of the licence; •safe use and operation of equipment; •instructions that should be provided to patients and patient helpers; •institutional radiation protection policies and procedures (including emergency practice drills); •the local QA programme and QC procedures; •the results of review and analysis of incidents and accidents that have occurred in the institution or elsewhere. Nuclear Medicine Part 9. Quality Assurance 97 A note of Qualifications of others There should also be a process in place which ensures that outside contractors on whom radiation protection may depend (e.g. service engineers) are appropriately trained and qualified. Nuclear Medicine Part 9. Quality Assurance 98 Education and Training In addition to the staff working within the nuclear medicine department, the following staff should receive instruction from the RPO: nurses in wards with radioactive patients; staff who do not belong to the nuclear medicine practice but need to enter controlled areas; and staff who transport radioactive patients or radioactive materials within the institution. Nuclear Medicine Part 9. Quality Assurance 99 Education and Training * Basic and continuing training for those who have responsibilities for the operation of the equipment or for preparations of radiopharmaceuticals. * Advanced training for physicians, physicists and radiochemists. * Continuing education for those who have operational responsibilities in a nuclear medicine facility. Nuclear Medicine Part 9. Quality Assurance 100 Continuing Education It is essential for all staff to have regular updates on radiation protection aspects Continuing education must be documented Nuclear Medicine Part 9. Quality Assurance 101 Education and Training If the number of professionals is too small to justify setting up a training course, then international co-operation programs may be used Distance learning programs may be useful A course such as the present may play an important role... Nuclear Medicine Part 9. Quality Assurance 102 Education and Training Continuing education in annual refresher training courses, and whenever there is a significant change in duties, regulations, terms of the license, or type of radioactive material or instruments used. Topics should be selected from a syllabus which has been approved by the RPC. Today we will talk about Patient safety Nuclear Medicine Part 9. Quality Assurance 103 Radiation Protection Training Programme • Basic radiation physics. • Biological effects of radiation. • International standards in Radiation Protection • Responsibility and duties. • Safe handling of radioactive materials. • Occupational radiation protection. • Medical exposure. • Management of radioactive waste. • Protection of the public. • Emergency preparedness. • Organization of radiation protection Nuclear Medicine Part 9. Quality Assurance 104 Training Record The records should include the following information: (a) Name of the person(s) who delivered the instruction or training; (b) Name of the person(s) who received the instruction or training; (c) Date and duration of the instruction or training; (d) List of the topics addressed; (e) Copy of the certificates of training Nuclear Medicine Part 9. Quality Assurance 105 Education and Training The Regulatory Authority should establish training curricula for (for example) : RPOs members of the RPC relevant physicians medical physicists laboratory staff Nuclear Medicine Part 9. Quality Assurance 106 The Role of Regulatory Authority Require key personnel (named in RPP) to be duly accredited/qualified and to have adequate training in radiation protection. Specify/approve minimum training standards/syllabus content for radiation protection training courses. Provide training courses, perhaps in conjunction with other contributors, if courses are otherwise unavailable in the country. Nuclear Medicine Part 9. Quality Assurance 107 Continuous Quality Improvement CQI - many other acronyms are available for this Part of virtually all QA systems Improved methods are documented in clinical trial reports. Quality assurance protocols are continuously under development in many countries Regular Quality Assurance meeting for all members of a Section Continuing education - lectures, workshops, journal clubs and must be available for all staff Nuclear Medicine Part 9. Quality Assurance 108 And finally: QA is not a threat, it is an opportunity It is essential in a QA program that all staff feel free to report errors A non threatening environment must exist Reward honesty with encouragement Education is the key, not punishment Nuclear Medicine Part 9. Quality Assurance 109 What is This? Communication! Nuclear Medicine Part 9. Quality Assurance 110 Questions? Nuclear Medicine Part 9. Quality Assurance 111 Discussion How should the quality of a nuclear medicine practice be measured? Nuclear Medicine Part 9. Quality Assurance 112 Discussion Discuss the responsibilities in QA for the different members of the nuclear medicine staff. Nuclear Medicine Part 9. Quality Assurance 113 Discussion Which one of the following practices has the highest quality of the practice: 1. The most modern equipment and unqualified persons running it. 2. Old equipment and qualified people running it. Nuclear Medicine Part 9. Quality Assurance 114 Where to Get More Information Further readings IAEA TECDOC 602 Basic Safety Standards: Interim Edition, 2011 WHO publications ISO publications Nuclear Medicine Part 9. Quality Assurance 115