The document discusses quality assurance in nuclear medicine, outlining general principles and procedures for ensuring high quality patient care and radiation safety. It covers organizing a quality assurance program, administrative routines like requesting exams and generating reports, monitoring occupational and medical exposure, maintaining instrumentation, and educating staff. The overall goal is continual improvement in diagnostic accuracy, effective use of resources, and optimization of radiation dose for patients and workers.

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

3. Content General principles Organization of QA Administrative routines Occupational and Medical exposure Instrumentation Education and training

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.

7. 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

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)

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

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

16. Clinical problem Radiopharmaceutical Instrumentation Diagnosis and therapy with unsealed sources NUCLEAR MEDICINE

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)

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

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

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.

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.

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

28. PATIENT MOVEMENT

29. PATIENT MOVEMENT moving moving moving

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

31. Policies and Procedures Manual As a minimum, sections should exist for Administrative procedures Clinical procedures Radiation safety

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

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

36. 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

37. Analysis of the programme code Phantom studies Simulated examinations Reference data (normal material) Clinical evaluation Q C Application programmes

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.

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;

45. RECORDS (cont) 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.

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.

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

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

51. 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

52. 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.

53. PREPARATION OF RADIOPHARMACEUTICALS Tc99m-MDP 2237 5 447 SC 1997-09-28 7.40 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 radiopharma- ceutical?

54. DISPENSING RADIOPHARMACEUTICALS Tc99m-MDP 400 MBq 400928-3336 1997-09-28 07.45 SC 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

55. 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!

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.

57. 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

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

61. PURCHASE GROUP Nuclear medicine specialist Nuclear medicine technologist Medical physicist Medical engineer Person from the hospital administration

62. 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

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

68. 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

69. Siting of equipment Sufficient space Electrical power Environmental factors (temperature, humidity, air pollution) Structural shielding Background radiation

70. MAINTENANCE Regular maintenance will result in: Increased availability of equipment Increased quality by better performance Increased safety Increased lifetime of equipment

71. 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.

72. EQUIPMENT Well trained staff with access to manuals and other documentation. Quality control program. Regular maintenance. NEEDS FOR EFFICIENT USE

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

77. 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

78. 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

79. What shall the vendor specify? Hardware: Crystal size and shape PM-tubes Gantry dimension and weight Gantry movements, including auto- contour Electrical power requirements Imaging table Collimators and method of change Shielding of detector Operating console Energy windows Energy range Safety features Motion control

80. 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

81. 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 What shall the vendor specify?

82. 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

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

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

85. 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?

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!!

88. Step 4 Make a clear and detailed specification of the implemen- tation 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

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

93. 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

94. Education and Training are essential for a radiation protection programme As part of a the implementation of a Radiation Protection Programme (IAEA TECDOC 1040, 2.2.1): “Early in the process a decision should be made about additional training required for the hospital staff…” The relevant plan should include who, where and when shall be trained.

95. Responsibility of the licensee BSS 2.30.: “Provision shall be made for reducing as far as practicable the contribution of human error to accidents and other events that could give rise to exposures, by ensuring that: (a) all personnel on whom protection and safety depend be appropriately trained and qualified so that they understand their responsibilities and perform their duties with appropriate judgement and according to defined procedures;”

96. 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 … .

97. 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.

98. 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.

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.

101. Continuing Education It is essential for all staff to have regular updates on radiation protection aspects Continuing education must be documented

102. 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...

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

104. 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

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

106. Education & Training The Regulatory Authority should establish training curricula for (for example) : RPOs members of the RPC relevant physicians medical physicists laboratory staff

107. 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.

108. 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

109. 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

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 .

114. DISCUSSION Which one of the following practices has the highest quality of the practice: The most modern equipment and unqualified persons running it. Old equipment and qualified people running it.

115. Where to Get More Information Further readings IAEA TECDOC 602 Basic Safety Standards WHO publications ISO publications