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Part 9 Part 9 Quality Assurance Quality Assurance IAEA Training Material Radiation Protection in Nuclear Medicine

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  • Part 9Quality AssuranceIAEA Training Material Radiation Protection in Nuclear Medicine

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*ObjectiveTo 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

    Nuclear Medicine

    Part 9. Quality Assurance* ContentsGeneral principlesOrganization of QAAdministrative routinesOccupational and Medical exposureInstrumentationEducation and training

    Part 9. Quality Assurance

  • Part 9.Quality AssuranceIAEA Training Material on Radiation Protection in Nuclear Medicine

    Module 9.1. General Principles

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*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

    Nuclear Medicine

    Part 9. Quality Assurance*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.

    Quality Assurance BSS: Interim Edition

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Quality Assurance BSS: Interim Edition3.170 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

    Nuclear Medicine

    Part 9. Quality Assurance*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

    Nuclear Medicine

    Part 9. Quality Assurance*Quality Assurance(Definition)all those planned and systematic actions necessaryto provide adequate confidence that a product orservice will satisfy given requirements for quality(ISO)

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*QA and QCQuality Assurance is the overall process which is supported by Quality Control activitiesQuality Control describes the actual mechanisms and procedures by which one can assure quality

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*QualityQuality of a practice is to fulfil the expectations and demands from:PatientClinicianYourself

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Quality AssuranceProtectionSafetyOVERALL QUALITYDiagnosticsTherapy

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*QualityDefine ObjectivesHow many times should the nursebe allowed to drop the child?What is an acceptable sens-itivity and specificity?

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Nuclear Medicine Service

    Primary serviceSecondaryserviceNuclearmedicineexaminationortreatmentfacilitiespatient carewaiting timestaffreportingcompetenceexperienceoptimisationradiopharmaceuticalsmethodsexamination techniqueinstrumentationetcetc

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Quality AssessmentCommunication with the client (patient, clinician).ExpectationsAcceptable levelReality

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Clinical problemRadiopharmaceutical InstrumentationDiagnosis and Therapy withUnsealed SourcesNuclear Medicine

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Quality Assurance ProgrammeA quality assurance programme in nuclear medicine shouldideally 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, physicistsand technologists and others involvedData 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, patientsatisfaction, referring physician satisfaction)Audit

    Part 9. Quality Assurance

  • Module 9.2. OrganizationPart 9.Quality AssuranceIAEA Training Material on Radiation Protection in Nuclear Medicine

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*International bodiesRecommendations.Interlaboratory comparison programmes.Education and training.National organizationsNational guidelines, codes of practice etc.Interlaboratory comparison programmes.Education and training.IndustryAssistance in acceptance tests.Documentation.Training.Maintenance.Professional associationsSupporting QA-programmesEstablishing working groupsEducation and trainingOrganizations

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Local OrganizationHospital manager (licensee)QA committeeQA-group nuclear medicine(chief technician, physicist, physician, pharmacist)

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*QA Committee MembershipMust represent the many disciplines within the departmentShould be chaired by the Head of DepartmentAs a minimum must include a medical doctor, a physicist, a technologist and an engineer responsible for service and maintenanceMust be appointed and supported by senior managementMust have sufficient depth of experience to understand the implications of the processMust have the authority and access to the resources to instigate and carry out the QA process

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Quality Assurance CommitteeShould represent the departmentShould be visible AND accessible to staffOversees the entire Quality Assurance programWrites policies to ensure the quality of patient careAssists 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

  • Module 9.3. Administrative RoutinesPart 9.Quality AssuranceIAEA Training Material on Radiation Protection in Nuclear Medicine

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Administrative RoutinesRequestPatient id and careComputer evaluationDiagnosticreportExaminationMethod

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*RequestIt is the responsibility of the nuclear medicine specialistthat the study requested by the referring physician isjustified. 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 thereferring clinician and the nuclear medicine specialistis very important.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Patient Identification of the patient Information about the examination including premedications Waiting for the examinationA fully informed and motivated patient is thebasis for a successful examination as well asa staff well educated in care of the patient.

    Part 9. Quality Assurance

    Nuclear Medicine

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

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Patient Movement

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Patient Movementmovingmovingmoving

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Policies and Procedures ManualReviewed (typically) yearlyThis manual contains clear and concise statements of all the policies and procedures carried out in the departmentUpdated as procedures changePolicies and Procedures Manual

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Policies and Procedures ManualAs a minimum, sections should exist forAdministrative proceduresClinical proceduresRadiation safety

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Policies and Procedures ManualIt must be signed off by the Head of Department and appropriate section headsIt is important that all staff have ownership to the manual - it should reflect the opinions of all and be agreed to by allA list of all copies of the Manual and their location must be kept to ensure that each copy is updated

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Methods should be in accordance with accepted practicesStudy name:Bone scanPreparation of patient:Empty bladderRadiopharmaceutical:Tc99m-MDPRoute of administration:IV injectionActivity:400 MBqType of examination:Whole body scanViews:AP, PAScanning speed:10 cm/minuteCollimator:ScanningWindow setting:140+/-20% keVPositioning of patient:SupinePresentation of result:Images in BW on film. Original and filtered.Methods

    Part 9. Quality Assurance

    Nuclear Medicine

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

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*MethodsTl-201 Tc-99m25 mSv 8 mSv

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Efficient use of computers can increase the sensitivity and specificity of an examination.software based on published and clinically tested methodswell documented algorithmsuser manuals trainingsoftware phantomsQuality AssuranceComputer Evaluation

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Analysis of the programme codePhantom studiesSimulated examinationsReference data (normal material)Clinical evaluationQC Application Programmes

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Bone Scan Phantom

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Thyroid Phantom

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Diagnostic ReportPatient identificationDate and type of studyRadiopharmaceutical and activityStudy results - e.g. a graph or a series of imagesObjective description of findingsDiagnostic conclusion and recommendations

    Avoid adjectives like possible, probable, likelyetc. They can never be interpretated by the referringphysician. The diagnostic conclusion should be morequantitative e.g. by using a probability statement.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Patient follow-up.Correlation with other availablesurgical, pathological, clinical andanatomic information.False positives?False negatives?Quality AssuranceMethod

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Society of Nuclear MedicineProcedure Guideline for General ImagingThe 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.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*RecordsAuthorization 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

    Nuclear Medicine

    Part 9. Quality Assurance*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; andCopy of the certificates of training.Evidence of health surveillance of workers;Waste disposal;Transportation:Package documentation;Package surveys;Transfer/receipt documents; andDetails of shipments dispatchedPatient records; andPatient discharge surveys for patients receiving radionuclide therapy.

    Part 9. Quality Assurance

  • Module 9.4. Occupational and Medical ExposurePart 9.Quality AssuranceIAEA Training Material on Radiation Protection in Nuclear Medicine

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*ExaminationRequestPatient id and careComputer EvaluationDiagnosticreportExaminationMethod

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*The patient shall always be confidentthat a nuclear medicine examination and therapy is performed correctly and with highest possible quality regarding both diagnostics/therapy and safety.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Medical ExposureChoice of examinationDetermination of technical parametersOptimization of administered activityMethods of reducing the absorbed doseQuality control of equipment and radiopharmaceuticalQuality assurance of methodsSafe routines to avoid misadministration

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Factors Affecting Medical and Occupational ExposureReceipt andstoragePreparationContaminationRadioactivewasteDetection(QC equipment)Administration

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Quality ControlRadiopharmaceuticals Radionuclide purity (other radionuclides?) Radiochemical purity (labelling efficiency) Chemical purity (toxic substances?) Sterility Absence of pyrogensResponsibility of the approved manufacturerand supplier

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance* 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.Quality AssuranceRadiopharmaceuticals

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Preparation of RadiopharmaceuticalsTc99m-MDP2237 5447 SC1997-09-28 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?

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Tc99m-MDP 400 MBq400928-33361997-09-28 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 Dispensing Radiopharmaceuticals

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance* 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!Injecting Radiopharmaceuticals

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*The worker should always feel confidentthat he/she has the necessary trainingin order to perform his/her duty.

    The worker should feel that he/she gets thenecessary support from the licensee inmatters concerning working situation andsafety.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Factors Affecting QualityDesign of facilitySafe receipt and storage of unsealed sourcesSafe handling of unsealed sourcesManagement of radioactive wasteSafety equipmentPersonal monitoringHealth surveillanceWorkplace monitoringEmergency proceduresLocal rulesTraining and experience of staff

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Education of StaffCorrect use of EquipmentClose 15 cm Wrong setting of energy window

    Part 9. Quality Assurance

  • Module 9.5. InstrumentationPart 9.Quality AssuranceIAEA Training Material on Radiation Protection in Nuclear Medicine

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*How to get a newGamma camera?

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Purchase GroupNuclear medicine specialistNuclear medicine technologistMedical physicistMedical engineerPerson from the hospital administration

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*How to open the safe?Careful analysis of the need and state the reasons forthe purchase of the gamma cameraEstablishment of a nuclear medicine serviceIncreased volume of patientsThe technical performance is not good enough for new methodsNo spare parts availableUnrepairable

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*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

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Basic Calculation*) depends on the type of camera

    Part 9. Quality Assurance

    Type of examination

    Examinations per week

    Time (h) per examination *)

    Total time (h) per week

    Bone

    20

    1

    20

    Lungs

    6

    0.5

    3

    Liver

    2

    0.8

    2

    CBF

    5

    1

    5

    Myocard

    10

    2

    20

    Kidneys

    8

    0.75

    6

    Thyroid

    5

    0.5

    3

    Others

    4

    1

    4

    Quality control

    1

    3

    3

    Total

    61

    66

    Nuclear Medicine

    Part 9. Quality Assurance*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.Result:Number of Cameras

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*End of step 1

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Let the vendordefine Your needs and make the selectionWrite a tender document and distributeit to the vendors

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Choice of EquipmentType of procedure to be undertakenTechnical specificationsManufacturerSpare partsService and maintenanceUser and service manualsEducation and trainingLocal userService and maintenanceEducation and experience of staffSiting of the instrumentEase, reliability and safety in operationCost

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Setting of EquipmentSufficient spaceElectrical powerEnvironmental factors (temperature, humidity, air pollution)Structural shieldingBackground radiation

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*MaintenanceRegular maintenance will result in:Increased availability of equipmentIncreased quality by better performanceIncreased safetyIncreased lifetime of equipment

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Maintenance Proceduresshould 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.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Equipment Well trained staff with access to manuals and other documentation. Quality control program. Regular maintenance.NEEDS FOR EFFICIENT USE

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Purpose of TenderingThe 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.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*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?

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*What do we want?Computer & software

    Acquisition modes?Application programmes?Network?Storage capacity?Backup?

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*What do we want?More...

    Education and trainingPaymentWarrantyReliabilityService and maintenanceList of usersManuals and other documentationTime of deliveryUpgradabilityQuality control equipmentAcceptance test

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*System overviewContact personsCommercial specificationsTechnical specificationsData acquisition and processingElectrical and mechanical safety (national regulations)Education and trainingDocumentationService organizationInstallation and acceptance testingThe Tender Document Should Therefore Include:

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Commercial specifications:

    PricePaymentWarrantyLiability insurance for installersRight to refuse or remove equipmentValue of the old cameraWhat shall the vendor specify?

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Hardware:Crystal size and shapePM-tubesGantry dimension and weightGantry movements, including auto- contourElectrical power requirementsImaging tableCollimators and method of changeShielding of detectorOperating consoleEnergy windowsEnergy rangeSafety featuresMotion controlWhat shall the vendor specify?

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance* Technical performance:

    LinearityUniformity (different energies, different angles)Energy resolutionSpatial resolution (intrinsic and system, planar and tomographic)Count rate performanceCenter of rotationMultiple window spatial positioningSystem sensitivity (planar and tomographic)Point source sensitivityWhat shall the vendor specify?

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Computer system:

    Acquisition modesBasic application programmesClinical application programmesQuality control programmesDICOM-standardNetwork and communicationPrintersStorage and backup of patient dataWhat shall the vendor specify?

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*..and more:

    User lists and site visitsReliability (e.g. 95%)Service response time and follow upTraining now and laterService manualsUpgradabilityDelivery, setup and installation dateFloor loading, elevators and doorsElectrical requirements

    What shall the vendor specify?

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Distribute the tender documents to the vendorsRELAX!End of step 2

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*The decision:

    Which camera fulfills ourrequirements?

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance* 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?The Decision

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Site Visits

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*The Decision- End of step 3Manufacturer 1+ price+ technical parameters- service- computer systemManufacturer 2+ price- technical parameters+ service- computer systemWe want that one!!

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*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 contractMake the installationPerform an acceptance test

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Quality ControlEquipmentAcceptance / reference testing.Measurements to assess whetherinstrumentation comply with itsspecifications. Manual available.Routine testing.Performed to maintain high quality andstandard of the equipment.Analysis of results.Is the observed result significantlydifferent from the reference testing?Is the observed result due to errors inthe QC procedure?Records.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Acceptance TestsX-ray installations 171

    Passed 10Passed after minor corrections 123Not passed 38

    (SSI 1992)

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance* Acceptance Daily Weekly YearlyUniformityPTTPUniformity, tomographyPPSpectrum displayPTTPEnergy resolutionPPSensitivityPTPPixel sizePTPCenter of rotationPTPLinearityPPResolutionPPCount lossesPPMultiple window posPPTotal performance phantomPP

    P: physicist, T: technicianQC Gamma Camera

    Part 9. Quality Assurance

  • Module 9.6. Education and TrainingPart 9.Quality AssuranceIAEA Training Material on Radiation Protection in Nuclear Medicine

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*How to achieve a high standard of safety in a hospital?Safety cultureSupport from the hospital managementWell educated staffLocal radiation protection organizationQuality assurance programmeUse of authorized servicesContinuing education and trainingArrangements for individual monitoring and health surveillanceRecordsDocumented local rules and procedures

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Education and Training are essential for a radiation protection programmeUse recommendations as stipulated in ICRP Publication 113The relevant plan should include who, where and when shall be trained.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*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.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*EducationAll staff in nuclear medicine must have appropriate education to perform their dutiesFor radiation protection purposes this affects particularly:Radiation Protection OfficerPhysicianQualified Expert (Medical Physicist)Nuclear Medicine Technician.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*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.Education and Training

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*A note of Qualifications of othersThere 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.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Education and TrainingIn 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.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*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.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Continuing Education

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

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Education and TrainingIf the number of professionals is too small to justify setting up a training course, then international co-operation programs may be usedDistance learning programs may be usefulA course such as the present may play an important role...

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Education and TrainingContinuing 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

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*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

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Training RecordThe 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

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Education and TrainingThe Regulatory Authority should establish training curricula for (for example) :RPOsmembers of the RPCrelevant physiciansmedical physicistslaboratory staff

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*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.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Continuous Quality ImprovementCQI - many other acronyms are available for thisPart of virtually all QA systemsImproved methods are documented in clinical trial reports.Quality assurance protocols are continuously under development in many countriesRegular Quality Assurance meeting for all members of a SectionContinuing education - lectures, workshops, journal clubs and must be available for all staff

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*And finally: QA is not a threat, it is an opportunityIt is essential in a QA program that all staff feel free to report errorsA non threatening environment must existReward honesty with encouragementEducation is the key, not punishment

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*What is This?Communication!

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Questions?

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*DiscussionHow should the quality of a nuclear medicine practice be measured?

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*DiscussionDiscuss the responsibilities in QA for the different members of the nuclear medicine staff.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*DiscussionWhich 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.

    Part 9. Quality Assurance

    Nuclear Medicine

    Part 9. Quality Assurance*Where to Get More Information

    Further readingsIAEA TECDOC 602Basic Safety Standards: Interim Edition, 2011WHO publicationsISO publications

    Part 9. Quality Assurance

    Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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.Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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,Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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,Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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 hospitalPart 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*An important slide - the lecturer should take some time to take the participants through it.Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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).Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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 bluePart 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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.Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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 correspondingPart 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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?Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*This is an example of a transmission phantom simulating a bone scanPart 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*This is an emission phantom simulating the thyroidPart 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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,Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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 programmePart 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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 exposurePart 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*The first two lines illustrate the situation where another gamma camera is needed. The next three describe situations where an old camera should be replaced by a new onePart 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*These are the factors to consider in the choice of equipmentPart 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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.Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*The title says it all: essential (here the lecturer can also point towards the role of the present course)Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*The road can be used to symbolize two things:Fast developmentContinuingPart 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*The no parking symbol illustrates the fact that one cannot stand still in QA.Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*The last two points are important: openness must be encouraged. Any problem becomes worse if it is not addressed. Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*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.Part 9 Quality AssurancePart 9 Quality AssuranceRadiation protection in nuclear medicine*