Part 9

1. Part 9 IAEATraining Material Radiation Protection in Nuclear Medicine Quality Assurance

2. 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 Part 9. Quality Assurance

3. Contents • General principles • Organization of QA • Administrative routines • Occupational and Medical exposure • Instrumentation • Education and training Part 9. Quality Assurance

4. Part 9.Quality Assurance IAEA Training Material on Radiation Protection in Nuclear Medicine Module 9.1. General Principles

5. 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 Part 9. Quality Assurance

6. 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.” Part 9. Quality Assurance

7. 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” Part 9. Quality Assurance

8. 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.” Part 9. Quality Assurance

9. 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) Part 9. Quality Assurance

10. 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 Part 9. Quality Assurance

11. Quality Quality of a practice is to fulfil the expectations and demands from: Clinician Patient Yourself Part 9. Quality Assurance

12. Quality Assurance OVERALL QUALITY Protection Safety Diagnostics Therapy Part 9. Quality Assurance

13. QualityDefine Objectives How many times should the nurse be allowed to drop the child? What is an acceptable sens- itivity and specificity? Part 9. Quality Assurance

14. Nuclear Medicine Service facilities patient care waiting time staff reporting competence experience optimisation radiopharmaceuticals methods examination technique instrumentation etc etc Nuclear medicine examination or treatment Primary service Secondary service Part 9. Quality Assurance

15. Quality Assessment Communication with the client (patient, clinician). Expectations Acceptable level Reality Part 9. Quality Assurance

16. Nuclear Medicine Diagnosis and Therapy with Unsealed Sources Clinical problem • Radiopharmaceutical Instrumentation Part 9. Quality Assurance

17. 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 Part 9. Quality Assurance

18. Part 9.Quality Assurance IAEA Training Material on Radiation Protection in Nuclear Medicine Module 9.2. Organization

19. 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 Part 9. Quality Assurance

20. Local Organization Hospital manager (licensee) QA committee QA-group nuclear medicine (chief technician, physicist, physician, pharmacist) Part 9. Quality Assurance

21. 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 Part 9. Quality Assurance

22. 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 Part 9. Quality Assurance

23. Part 9.Quality Assurance IAEA Training Material on Radiation Protection in Nuclear Medicine Module 9.3. Administrative Routines

24. Administrative Routines Request Patient id and care Examination Method Computerevaluation Diagnostic report Part 9. Quality Assurance

25. 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. Part 9. Quality Assurance

26. 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. Part 9. Quality Assurance

27. Young Patients ..should also be informed and motivated Part 9. Quality Assurance

28. Patient Movement Part 9. Quality Assurance

29. Patient Movement moving moving moving Part 9. Quality Assurance

30. 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 Policies and Procedures Manual Part 9. Quality Assurance

31. Policies and Procedures Manual • As a minimum, sections should exist for • Administrative procedures • Clinical procedures • Radiation safety Part 9. Quality Assurance

32. 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 Part 9. Quality Assurance

33. Methods Methods should be in accordance with accepted practices Study name: Bone scan Preparation of patient: Empty bladder Radiopharmaceutical: Tc99m-MDP Route of administration: IV injection Activity: 400 MBq Type of examination: Whole body scan Views: AP, PA Scanning speed: 10 cm/minute Collimator: Scanning Window setting: 140+/-20% keV Positioning of patient: Supine Presentation of result: Images in BW on film. Original and filtered. Part 9. Quality Assurance

34. Methods Static? Tomographic? Dynamic? Part 9. Quality Assurance

35. Methods Tl-201 Tc-99m 25 mSv 8 mSv Part 9. Quality Assurance

36. Quality AssuranceComputer Evaluation • Efficient use of computers can • increase the sensitivity and • specificity of an examination. • software based on published andclinically tested methods • well documented algorithms • user manuals • training • software phantoms Part 9. Quality Assurance

37. QC Application Programmes • Analysis of the programme code • Phantom studies • Simulated examinations • Reference data (normal material) • Clinical evaluation Part 9. Quality Assurance

38. Bone Scan Phantom Part 9. Quality Assurance

39. Thyroid Phantom Part 9. Quality Assurance

40. Part 9. Quality Assurance

41. 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. Part 9. Quality Assurance

42. Quality AssuranceMethod Patient follow-up. Correlation with other available surgical, pathological, clinical and anatomic information. False positives? False negatives? Part 9. Quality Assurance

43. 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 Part 9. Quality Assurance

44. 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; Part 9. Quality Assurance

45. 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. Part 9. Quality Assurance

46. Part 9.Quality Assurance IAEA Training Material on Radiation Protection in Nuclear Medicine Module 9.4. Occupational and Medical Exposure

47. Examination Request Patient id and care Examination Method ComputerEvaluation Diagnostic report Part 9. Quality Assurance

48. Patient 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. Part 9. Quality Assurance

49. 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 Part 9. Quality Assurance

50. Factors Affecting Medical and Occupational Exposure Receipt and storage Preparation Detection (QC equipment) Administration Radioactive waste Contamination Part 9. Quality Assurance