1. Quality Assurance IAEA Training Material Radiation Protection in Nuclear Medicine

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

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

5. 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; and ` b) quality control mechanisms and procedures for reviewing and assessing the overall effectiveness of protection and safety.

6. Meaning for medical exposure that: 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.

8. BSS II.23. Quality assurance programmes for medical exposures shall include: a) measurements of the physical parameters of the radiation generators, imaging devices and irradiation installations at the time of commissioning and periodically thereafter, b) verification of the appropriate physical and clinical factors used in patient diagnosis or treatment; c) written records of relevant procedures and results d) verification of the appropriate calibration and conditions of operation of dosimetry and monitoring equipment; and e) as far as possible, regular and independent quality audit review of the quality assurance programme for radiotherapy procedures.

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)

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

12. QUALITY ASSURANCE Protection Safety OVERALL QUALITY Diagnostics Therapy

13. QUALITY DEFINE OBJECTIVES How many times should the nurse be allowed to drop the child? What is an acceptable sens- itivity and specificity?

14. NUCLEAR MEDICINE SERVICE Primary service Secondary service Nuclear medicine examination or treatment facilities patient care waiting time staff reporting competence experience optimisation radiopharmaceuticals methods examination technique instrumentation etc etc

15. QUALITY ASSESSMENT Communication with the client (patient, clinician). Expectations Acceptable level Reality

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

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

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

20. LOCAL ORGANIZATION Hospital manager (licensee) QA committee QA-group nuclear medicine (chief technician, physicist, physician, pharmacist)

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

24. ADMINISTRATIVE ROUTINES Request Patient id and care Computer evaluation Diagnostic report Examination Method

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.

27. YOUNG PATIENTS ..should also be informed and motivated

28. PATIENT MOVEMENT

29. PATIENT MOVEMENT moving moving moving

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.

34. METHODS Static? Tomographic? Dynamic?

35. METHODS Tl-201 Tc-99m 25 mSv 8 mSv

38. Bone scan phantom

39. Thyroid phantom

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.

42. QUALITY ASSURANCE METHOD Patient follow-up. Correlation with other available surgical, pathological, clinical and anatomic information. False positives? False negatives?

43. Society of Nuclear Medicine Procedure Guideline for General Imaging 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.

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

47. EXAMINATION Request Patient id and care Computer Evaluation Diagnostic report Examination Method

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.

50. Factors affecting medical and occupational exposure Receipt and storage Preparation Contamination Radioactive waste Detection (QC equipment) Administration

56. Worker 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.

58. EDUCATION OF STAFF Correct use of equipment Close 15 cm Wrong setting of energy window

59. Module 9.5. Instrumentation Part 9. Quality Assurance IAEA Training Material on Radiation Protection in Nuclear Medicine

60. How to get a new Gamma camera? Step 1

63. 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

64. Basic calculation *) depends on the type of camera

65. 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.

66. End of step 1 No! Yes!

67. Let the vendor define Your needs and make the selection Step 2 Write a tender document and distribute it to the vendors

73. 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’.

74. 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?

75. What do we want? Computer & software Acquisition modes? Application programmes? Network? Storage capacity? Backup?

76. 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

83. End of step 2 Distribute the tender documents to the vendors RELAX!

84. Step 3 The decision: Which camera fulfills our requirements?

86. Site visits

87. The decision- End of step 3 Manufacturer 1 + price + technical parameters - service - computer system Manufacturer 2 + price - technical parameters + service - computer system We want that one!!

89. 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.

90. Acceptance tests X-ray installations 171 Passed 10 Passed after minor corrections 123 Not passed 38 (SSI 1992)

91. QC GAMMA CAMERA Acceptance Daily Weekly Yearly Uniformity P T T P Uniformity, tomography P P Spectrum display P T T P Energy resolution P P Sensitivity P T P Pixel size P T P Center of rotation P T P Linearity P P Resolution P P Count losses P P Multiple window pos P P Total performance phantom P P P: physicist, T: technician

92. Module 9.6. Education and training Part 9. Quality Assurance IAEA Training Material on Radiation Protection in Nuclear Medicine

99. 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.

100. EDUCATION AND TRAINING * Basic and continuing training for those who have responsibilities for the operation of the equipment or for preparations of radio- pharmaceuticals. * Advanced training for physicians, physicists and radiochemists. * Continuing education for those who have operational responsibilities in a nuclear medicine facility.

103. 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

105. 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

110. What is this? Communication!

111. Questions?

112. DISCUSSION How should the quality of a nuclear medicine practice be measured?

113. DISCUSSION Discuss the responsibilities in QA for the different members of the nuclear medicine staff .