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
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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.
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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)
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11. QUALITY Quality of a practice is to fulfil the expectations and demands from: Patient Clinician Yourself
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
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)
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23. Module 9.3. Administrative routines Part 9. Quality Assurance IAEA Training Material on Radiation Protection in Nuclear Medicine
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.
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.
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.
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46. Module 9.4. Occupational and medical exposure Part 9. Quality Assurance IAEA Training Material on Radiation Protection in Nuclear Medicine
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.
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50. Factors affecting medical and occupational exposure Receipt and storage Preparation Contamination Radioactive waste Detection (QC equipment) Administration
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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.
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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
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
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.
67. Let the vendor define Your needs and make the selection Step 2 Write a tender document and distribute it to the vendors
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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
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83. End of step 2 Distribute the tender documents to the vendors RELAX!
84. Step 3 The decision: Which camera fulfills our requirements?
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!!
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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
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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.
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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
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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
113. DISCUSSION Discuss the responsibilities in QA for the different members of the nuclear medicine staff .
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Editor's Notes
Sometimes the objective of quality is quite simple as illustrated to the left, while in diagnostic imaging it could be quite complicated e.g. when we are dealing with examinations where a good balance between the sensitivity and the specificity of the test is important.
This is an illustration to the nuclear medicine service in terms of quality. It can be described as a primary service which is simply the examination or treatment of the patient. This primary service is something that basically concern only the referring physician and the patient. The secondary service consists of all the components that lay behind an examination or treatment of high quality. If we fail to keep a high quality of the secondary service the result will certainly be a low quality of the primary service. The secondary service is something that only concerns the nuclear medicine department. The referring physician and the patient will not bother about how an examination or treatment is performed as long as it is of high quality,
This is a description of the nuclear medicine service as a triangle with the clinical problem, the radiopharmaceutical and the instrumentation occupying the three corners and with the patient in the center,
This is just a suggestion, It could be organized in other ways, for instance letting radiation protection be a sub-section of a general quality assurance organization within the hospital
An important slide - the lecturer should take some time to take the participants through it.
Represent the department means: should have representation form all major professional groups in the department. It also indicates that this includes all levels of staff (eg unionized, managerial, part time).
This is a general description of the different components of a nuclear medicine examination. Administrative routines are involved in all but especially the ones marked in blue
This is a DMSA-examination. To the left the image acquired with the patient moving. The result will be an inconclusive examination. The same examination with the patient not moving is shown to the right.
This is another example, where the patient movement is resulting in a false positive result. It is a myocardial scan with Tc-sestamibi, Note the differences between the acquisitions. The slices are corresponding
These are myocardial scans of the same patient acquired with Tl201 and with Tc99m. The message is that if there are no significant differences between the results, the radiopharmaceutical giving the lowest effective dose should be chosen. Are there any differences between the images?
This is an example of a transmission phantom simulating a bone scan
This is an emission phantom simulating the thyroid
This is an application program that makes a comparison of the regional distribution of DMSA between the patient examination and a database of normal studies,
These are factors that affect the medical exposure. Quality assurance in medical exposure means that all factors should be checked regularly in a quality assurance programme
This is the life of the unsealed sources in the nuclear medicine department. High quality in each of the components means an optimization of both occupational and medical exposure
The first two lines illustrate the situation where another gamma camera is needed. The ne x t three describe situations where an old camera should be replaced by a new one
These are the factors to consider in the choice of equipment
This is an example from Sweden. The Authorities examined 171 installations of X-ray machines. The manufacturer declared the machines as ready for use on patient examinations. An independent acceptance test showed that only 10 installations were OK! Thirty-eight of the installations had major faults and should not be used for patient examinations. The message is that the acceptance test should not be performed by the manufacturer. It should be done by the user or independent person together with the manufacturer.
The title says it all: essential… (here the lecturer can also point towards the role of the present course)
The road can be used to symbolize two things: Fast development Continuing
The no parking symbol illustrates the fact that one cannot stand still in QA.
The last two points are important: openness must be encouraged. Any problem becomes worse if it is not addressed.
Let the audience guess. It is an image of what is left of a supernova registered with a radiotelescope. The message is that they could ask the teacher who knows the answer and not guess. Communication between the people involved in nuclear medicine is very important.
