QA in Medicine.cdr - Pakistan Nuclear Regulatory Authority
Contents
1. 44 45 REFERENCES 1 International Atomic Energy Agency Nuclear Medicine Resource Manual IAEA Vienna 2006 2 International Atomic Energy Agency Practice specific model regulations on radiation safety in nuclear medicine TECDOCX XXX Interim report IAEA Vienna August 2001 3 Pakistan Nuclear Regulatory Authority Regulations on Radiation Protection PAK 904 PNRA Islamabad 2004 4 Pakistan Nuclear Regulatory Authority Regulations for the licensing of Radiation Facility ies other than Nuclear Installation s PAK 908 PNRA Islamabad 2004 5 Institute for Nuclear Information Recommendation on Radiation Protection Quality Assurance Systems at Workplaces Using Nuclear Medicine Equipment Technology Zbraslav Co PAKISTAN NUCLEAR REGULATORY AUTHORITY P O Box 1912 Islamabad www pnra org2. VLII SOURCES OF EXPOSURE a Are the shielding amp other protective measures optimized for restricting public exposure to Yes No external sources of radiation b Are the floor plans amp arrangement of equipment as described in the application appropriate Yes No considering any public areas adjacentto the installation RADIOACTIVE WASTE AND DISCHARGES a Have provisions been made to transfer waste to an authorized waste disposal facility atthe end Yes No ofuse b If any sealed sources are no longer in use and being stored does the authorized organization Yes No have a plan for timely transfer or disposal of the sources C Are there provisions for control of discharges to the environment in the event of contamination Yes No VLIV MONITORING OF PUBLIC EXPOSURE Are routine periodic measurements of exposure rates in public areas adjacent to areas used for No diagnostic amp therapeutic purposes or radioactive materials made by staff or qualified experts b Do surveys show that the room shielding is adequate and the dose rates outside the areas meet Yes No authorized radiation levels Record independent measurements made during the inspection Type model no of survey meter Date last calibrated Are the inspector s independent measurements in agreement with the organization s routine Yes No measureme
3. than 10 More than 10 More than 2 mSv h but not more than 10 mSv h Yellow 111 a The TI shall be rounded up to the first decimal place except that a value of 0 05 or less may be considered as zero b shall be transported under exclusive use 7 1 4 Handling of Radioactive Waste It is the responsibility of hospital management to collect segregate and dispose off radioactive waste according to the Regulations on Radioactive Waste Management PAK 915 For further reference PNRA Safety Guide Guidelines for the Management of Radioactive Waste in Hospitals Nuclear medical Centres Research Facilities 13002 may be consulted 7 1 5 Source Transport The hospital administration person responsible should make local rules for in house transport of radioactive material If the injection is to be taken far from the dispensing room for administration to the patient a transport container with absorbent pads need to be provided The RPO must ensure that the container is labeled with a radiation warning sign It must also have the following information date activity name amp identification number of the patient for which the injection is prepared name of the technologist who prepared the dose and the name of the medical professional who prescribed the dose RPO must ensure that the most direct route is taken for transport avoiding heavily occupied areas and the time taken in the transport must be documented A rec
4. 37 IV V WARNING SYSTEMS Are warning signs notices Provided Yes Working Yes Legible Yes Inlocal language Yes No No No No IV VI SAFETY OPERATIONS MANAGEMENT a ls management familiar with the certificate of authorization amp its restrictions amp requirements Yes No b Does management provide adequate staffing levels Yes No c Has management invested the RPO with PNRAto stop unsafe operations Yes No d Does management provide adequate resources for personnel training Yes No e Does management provide adequate equipment Yes No f Does management provide for periodic programme reviews amp Scheduled Yes No recommendations Performed Yes No i Date ofthe last programme review ii Status of recommendations IV VII SAFETY OPERATIONS TECHNICAL a Does the RPO has adequate knowledge amp expertise Yes No b Does the RPO has qualified experts available Yes No C Is the RPO familiar with the requirements of PNRA amp the provisions of the certificate of Meam Yes No authorization d Is the RPO given sufficient time amp resources to do the job e g kept too busy in other Y in es No assignments or not given sufficient technical secretarial help e Is the RPO kept informed of activities of workers using radiation sources Yes No f Does the RPO conductinitial amp periodic t
5. 5 2 15 2 2 gt VARIABLES o 2 lt LES 5 Es 02 H 3 a S 51096 02 v Oz 2 zu xo x O xOz Pa rzO o0 60 54 zzobisozz 65 gz l n 51 ox rzz5 o5 mo r r amp 5 Collimator Damage 0 PMT Drift 0 Energy Peak Drift 0 0 z z Mechanical COR 0 E 4 n Electronic Noise Oo 0 0 Crystal Damage Coupling Dry 0 0 l l Contamination Spills 01 10 i i k Magnetic Fields 0 000 0 Power Fluctuations 0 0 0 0 0 0 Background 0 0 z Temperature Fluctuations O 0 8 Any Variable As a Function of 0 0 Angle Key Signifies that the test is unlikely to show sensitivity for the designated variable 0 Signifies some sensitivity for the designated variable Signifies high sensitivity for the designated variable 111 lv High Count Intrinsic Uniformity Flood High count density intrinsic floods should initially be acquired weekly afterwards the frequency of the test is adjusted according to the camera s stability Departments using multiple radionuclides should rotate radionuclides used for this test amp compare images t
6. PNRA RG 904 01 October 2009 Rev 0 QUALITY ASSURANCE IN NUCLEAR MEDICINE REGULATORY GUIDE PAKISTAN NUCLEAR REGULATORY AUTHORITY For Further Details Directorate of Policies amp Procedures PAKISTAN NUCLEAR REGULATORY AUTHORITY P O Box 1912 Islamabad www pnra org TABLE OF CONTENTS 1 1 TN FRODUC TION ce 2 2 01A A ea uA orc 2 3 2 4 GENERAL PRINCIPLES OF QUALITY ASSURANCE 5 OPTIMIZATION OF QA 5 1 the Facility aee aine tree sheet even 3 5 2 QA Program dne Coates 3 5 3 Facility Organization icis ee iei EEEE 3 6 ADMINISTRATIVE 8 4 0 0000 eee etes tns tn etna enstnue 7 OCCUPATIONAL AND MEDICAL EXPOSURE 7 1 Radioactive Source Tracking ccccesccessesseeseeeseeseceeeeeeeseeseesseeaees 7 PAA Package penitig 2 oseeceeuee meii erede reete 7 7 1 2 Check of Sources 7 TABS SOTA yaw ee ee d 71 44 Handling of Radi 8 niky SourceS TRANS POTS 8 8 RADIOPHARMACEUTICALS cresce eene e eene eere eere netos tone tne sena 8 8 1 Radionuclide Generators essere 9 8 1 1 Radionuclide Purity 8 1 2 Chemical Purity 8 1 3 P rtity rete trii totes ine
7. In order to attain high standards of efficiency amp reliability an appropriate quality assurance programme is mandatory The licensee is responsible to ensure that Site is appropriate for the installation ofthe camera Once received amp installed the licensee will perform a series of acceptance tests to confirm whether its initial performance confirms with the manufacturer s specifications At the same time reference tests are carried out to provide data against which its subsequent performance can be assessed by routine testing weekly monthly quarterly yearly etc Full technical specifications are obtained from the manufacturer covering all options of the instrument including power supply Operational checks amp servicing facilities are taken into account The Authority is informed before the operation of the gamma camera to evaluate the radiation protection requirements Operational amp service manuals fully updated accompany every instrument and Records of all such procedures amp tests are kept and produced at the time of regulatory inspection Asummary ofa general gamma camera QC is placed at table 5 The table 6 indicates the duties of the personnel responsible for QC of gamma camera ina nuclear medicine department SPECT Parameters The recommended QC tests fall broadly into three categories 1 Good Practice easy steps requiring only vigilance on the part of the technologist Very im
8. b Are the dosimeters i Worn properly ii Calibrated Yes No iii Exchanged at required frequency c Are personnel exposure within limits Yes No d Are area and portable survey instruments i appropriate ii calibrated Yes No iil operational Yes No iv checked before use Yes No v supplied with spare batteries e Do the authorized organization s surveys indicate that the shielding is adequate and the dose Yes No rates around storage and patient treatment rooms meet authorized radiation levels f Does the authorized organization make periodic tests for leakage of radioactive materials from Yes No any sealed sources e g calibration sources g Is the instrumentation i appropriate s No ii calibrated Yes No iii operational Record independent measurements made during the inspection Type model number of survey meter Date last calibrated Do the inspector s independent surveys confirm the survey results of the authorized organization Yes No Document any significant differences and any agreed upon plan to resolve the discrepancies 40 VI VERIFICATION OF PUBLIC PROTECTION VLI CONTROL OF VISITORS visitors accompanied in controlled areas Yes No b Is adequate information provided to visitors entering controlled areas Yes No C Are there adequate controls over entries into supervised areas amp appropriate postings Yes No
9. department establishes a QA group committee that is responsible for quality assurance issues While defining a QA Committee the following criteria must be kept in mind I Must be chaired by the Head of the Department il iii iv V vl vil Must include a nuclear medicine specialist a medical physicist the chief technician a pharmacist and an engineer responsible for service and maintenance Must be appointed and supported by senior management Mustrepresent many disciplines within the department Must have depth ofknowledge and experience Must have authority to exercise the powers to instigate and carry out the QA process and Should be accessible The QA Committee is responsible for il iii iv Establishing a comprehensive QA programme for radiation protection safety and image quality to ensure that all necessary procedures are developed and implemented to comply with the Radiation Protection Regulations PAK 904 within the terms and conditions of the authorization s ofthe facility Define policies and procedures to ensure quality patient care Provide assistance to the staff in tailoring the programme to meet the needs ofthe department and Systematically reviewing and auditing the entire QA programme such as administrative routines working procedures procedure manuals follow up of examinations and treatments quality control of equipment routine purchasing of equipment e
10. exception Eating drinking by a patient as part of a diagnostic procedure e g iodine therapy procedure Eating and drinking is allowed at the nursing station provided that no administration of radioactive substances is carried out at the time and if there is any contamination from previous administration has been dealt with by qualified persons Inthe waiting area eating and drinking is allowed as the area is not used for administration ofradiopharmaceuticals However if the area gets contaminated by the vomitus or urine or any other body fluids ofthe patient after radiopharmaceutical administration the area should be treated as controlled area No one should be allowed to eat and drink till the area is decontaminated and declared safe by RPO To avoid spread of contamination Activity must not be splashed around e g do not squirt syringes or expel in the air As far as practicable all operations involving unsealed sources should be carried out over a drip tray Syringes containing radioactive solutions should be placed with their shielding ina tray before transportation Any bench top which is used for the manipulation of unsealed sources e g blood samples should be covered with absorbent paper which should be replaced if contamination occurs and While wearing gloves which may be contaminated unnecessary contact with all other objects should be avoided Gloves should be removed and disposed off in the radioac
11. guidance level WORK IN A CONTROLLED AREA Access to controlled areas must be limited All regular staff of the area will be issued a personal dosimeter worn at all times when the person enters the room Occasional entry of any person without a dosimeter to a controlled area may be permitted under the supervision of an authorized member or RPO Other personnel who need to enter the controlled area on occasional basis at times when they are not being supervised works staff contractors etc must be issued with a permit to enter the controlled area Outside normal working hours controlled areas must be locked to prevent unauthorized access In order to avoid skin contamination and or accidental ingestion of radionuclides Laboratory coats or other suitable clothing should be worn to prevent accidental contamination of normal clothes Disposable plastic gloves should be worn when working with any unsealed sources Lab coats should be removed and hands washed before eating or drinking and before going home Disposable handkerchiefs should be used Skin cuts and abrasions should be covered before working with unsealed sources If there is any risk of splashing eyes should be protected e g behind the transparent lead block Mouth pipettes must never be used Always use a bulb pipette or a syringe for measuring radioactive solutions No one should eat drink smoke or apply cosmetics in controlled areas with the following
12. week for in vitro equipment Manufacturers of multiple detector systems also provide the software programmes for quality control instruction for carrying out these controls and evaluation of the measured results If the user does not proceed appropriately according to programmes included in the software QC test standardization setting the high voltage 1 e autocalibration amp others when setting and controlling the equipment the system indicates such an error 20 The system further indicates that the difference in particular parameters have exceeded the allowed value determined by the manufacturer In such cases it is necessary to repeat the test with special attention to proceed exactly according to the manufacturer s instructions When the test results repeatedly fail to be satisfactory the maintenance service must be contacted 10 3 Quality Control of Imaging Systems Scintillation Cameras The scintillation camera QC has two purposes It verifies whether the equipment produces images adequately corresponding to the distribution of radiopharmaceuticals in the patient and It contributes towards achieving the requirements of maximal diagnostic information gained under the lowest possible radiation exposure to patients and staff Gamma camera has now been developed into a very sophisticated series of imaging devices that permit dynamic amp tomographic imaging as well as conventional static planer imaging
13. 32 INSTRUCTIONS FOR VISITORS The nursing staff should be given the following recommendations Visitors are discouraged for a 48 hour period after the patient receives the treatment Pregnant women and children under the age of 18 are not permitted to visit Visit time should be very short lt 30 min A reasonable distance e g 2 m away from the patient must in any case be maintained Do noteat drink or smoke in the patient s room Do not touch the toilet or sink in the patient s room If there is any question in the mind of visitors the nursing staff should answer it or guide them to the treating physician 33 ANNEXURE III CHECKLIST FOR THE INSPECTION OF A NUCLEAR MEDICINE DEPARTMENT I AUTHORIZATION APPLICATION FOR USE OF UNSEALED RADIOACTIVE SOURCES IN MEDICINE I 1 TYPE OF AUTRHORIZATION New application Amendment Renewal LII PURPOSE OF APPLICAION Construction Import purchase Use beginning of operation LIII GENERALINFORMATION 1 NAME amp ADDRESS OF ORGANIZATION MAIN ADDRESS MAILING ADDRESS IF DIFFERENT ADDRESS OF USE IF DIFFERENT 2 amp QUALIFICATION OF SPECIALITY NAME DEGREE CERTIFICATION EXPERIENCE CONTACT NO Nuclear Physician Radiation Protection Officer Medical Physicist Nuclear Medicine technologist 3 NAME OF THE RESPONSIBLE PERSON ADMINISTRATOR Name T
14. CTURER MODEL NO NUMBER COMMENTS Radionuclide activity calibrator Imaging equipment Syringe shield L Block Tongs Forceps Lead blocks Well counter Generator Fume hood Xenon trap FACILITY DESIGN Describe any differences or modifications from those approved by PNRA amp considered in the safety assessment e g shielding design building materials floor plan a Was a safety assessment by a qualified expert performed prior to any modification Yes No b Is the thickness amp type of shielding appropriate for the types amp intensity of radiation produced by radioisotopes in use Yos No IV IV SAFETY CONTROL amp EQUIPMENT DESIGN a Are an adequate number of lead containers lead blocks and Provided Yes No portable or fixed shields available for shielding in storage and handling Used Yes No rooms ided b Is remote handling equipment such as tongs forceps etc available is ie C Are ventilated fume hoods for handling large doses of I 131 amp for Provided Yes No carrying out MEK methyl ethyl ketone 2 butanone extraction of Tc Used Yes No available 9 Are the drainage ducts the laboratory sinks wash basins toilets etc connected Yes No directly to the sanitary sewage system 15 adequate provision made for storage of wastes before disposal Yes No
15. ITIES 29 SAFE ADMINISTRATION OF I 131 ANNEXURE II GUIDANCE LEVEL FOR MAXIMUM ACTIVITY FOR PATIENTS IN THERAPY ON DISCHARGE FROM HOSPITAL RADIONUCLIDE ACTIVITY MBq lodine 131 1100 In some countries a level of 400 MBq is used Activity of 131 administered MBq Behaviour Restriction 30 200 200 400 400 600 600 800 Period Restriction d Stay at least 1 meter away from all 5 9 12 14 members of the household except for very brief periods a few minutes every da Restrict dose contact cuddling with 15 21 25 27 all members of the household to less than 15 minutes per day and sleep separately from them Sleep separately from comforters 4 8 Avoid prolonged dose contact more than 3 hours at lt 1 meter with other adults NOTE THAT The restriction times in the first two rows run concurrently e g for 30 200 MBq category a child should only be cuddled for brief periods for 5 days then cuddling must be restricted to 15 minutes per day for a further 10 days The dose constraint for third row is 5 mSv The fourth row only covers on single event whereas the other categories assume daily contact RESTRICTION FOR PATIENT WITH I 131 Activity Public travel Off Sleep apart from Restricted close contact with MBq allowed per day work d partner children 1 2 Pregnant No lt 2y 2 5y 5 11 week week d
16. P Energy resolution P P Sensitivity P T P Pixel size P P Centre of rotation P P Linearity P P Resolution P P Countlosses P P Multiple window pos P P Total performance phantom P P 22 P Physicist T Technician radiographer GOOD PRACTICE TESTS 23 I ii iii Visual Check of Energy Spectrum Look at peak position peak width or presence ofother activity peaks ofother radionuclides Background Activity Check Performed with the collimator on or off Cine Review of SPECT Data After acquisition amp before reconstruction cine review will show up patient motion along the axis of rotation background activity in the field of view variations in camera performance with view angle amp gross COR errors and Sinogram Review of Data It will give similar information as cine review of planar images but with greater sensitivity for lateral patient motion amp less for vertical shifts DAILY QC TESTS 1 Low Count Extrinsic or Intrinsic Flood A low count extrinsic or intrinsic flood should be performed daily on all camera heads for visual assessment of camera uniformity For clinical radionuclides other than Te it is important to verify intrinsic uniformity with the appropriate corrections on a regular schedule the frequency of which will depend on the variety of radionuclides used with a particular system and Visual Inspection of Collimators A visual inspection of collimators
17. SICIAN DECDRTA d SE ADIO Te 99m MINATION RECEPTION IN VIVO R D D A N PHAPMACY GENERA pra 5 COUNTING AOMN 1 jJ ace a o RECORDS PATIENT Sfonage E XAM 5 s 5 8 wr si anys ria E E E EXHAUST S SINK W T WORK TABLE new facilities should be constructed according to this plan low activity area must always be located near the entrance and high activity area is restricted and placed far beyond the patient waiting area Preexisting facilities should make alterations accordingly For convenience the categorization of the areas can be done according to the following criteria WEIGHTED ACTIVITY CATEGORY lt 50MBq Low Hazard 50 50000MBq Medium Hazard gt 50000MBq High Hazard 28 BUILDING REQUIREMENTS CATAGORY OF STRUCTURAL FLOORS WORKTOP SURFACES HAZARD SHIELDING WALLS CEILING LOW NO CLEANABLE CLEANABLE MEDIUM NO CONTINUOUS SHEET CLEANABLE CONTINUOUS ONE SHEET HIGH POSSIBLY FOLDED TO WALLS CLEANABLE NOTE What the room is used for should be taken into account e g waiting room BUILDING REQUIREMENTS CATEGORY OF HAZARD FUME HOOD VENTILATION PLUMBING FIRST AID Low NO NORMAL STANDARD WASHING WASHING amp MEDIUM YES GOOD STANDARD DECONTAMINATION FACILITIES MAY NEED MAY NEED WASHING amp SPECIAL FORCED SPECIAL HIGH TES VENTILATION PLUMBING PESE FACILITIES FACIL
18. TIONAL CHECKS 1 Reproducibility 2 Background response SIMPLE gt Energetic calibration 19 gt Short term reproducibility COMPLICATED gt Long term reproducibility gt Energetic resolution capability gt Sensitivity gt Linearity of energy response gt Activity response linearity Overview of tests of one detector amp two detector devices for in vitro and in vivo measuring and frequency of their performance is shown in the table 4 Multiple detector systems for in vitro measuring Particularly the same parameters as for classical systems with one detector are controlled in these systems used mainly for radio saturation analysis However higher number of detectors and construction of the device leads to some peculiarities The device is accustomed to detection of samples with very low photon radiation energy especially 1251 emitting roentgen radiation and gamma radiation with low energy of 30keV TABLE 4 Tests for One Detector Two Detector Devices amp their Frequency Frequency gt g o j lt o S 5 9 8 lt Test E 23 9 8 8 E 5 3 lt lt lt D Energetic calibration e x Stability Short term reproducibility E X X Long term reproducibility X Energetic resolution 9 X X 3 Sensitivity x X 8 Linearity of energy response 2 X X Activity response linearity X X Daily for in vivo equipment once a
19. The set limit is 0 15 uCiof Mo activity per 1 0 mCi of Tc activity in the administered dose 8 1 2 Chemical Purity Another routine QA step is to measure the generator eluate for the presence of ALO For fission generators the maximum alumina concentration is 10ug ml 8 1 3 Radiochemical Purity The standard set for the generator eluate is that 95 or more of Tc activity should be in 7 states 8 2 Radiopharmaceutical Behavior The behavior of radiopharmaceuticals is dependent upon its quality which demands high standards of radionuclide radiochemical and chemical purity and in case of suspensions of particle size and uniformity Injections have to satisfy additional standards of sterility apyrogenicity and freedom from foreign particulate matter 6 2 1 Radionuclide Purity Radionuclide purity is required to avoid unnecessary radiation dose to the patient to avoid degradation of image quality and to limit errors on measurements Radionuclide purity depends upon the half lives of the radionuclides involved Contaminants with longer half lives are potentially more hazardous 6 2 2 Radiochemical Purity In a nuclear medicine department either ready to administer radiopharmaceutical are used or else prepared through the reconstitution of non radioactive kits by adding a radionuclide The manufacturing of ready to inject radiopharmaceuticals and of non radioactive kits is subject to quality control 8 2 3 Chemica
20. d d d d h h 200 3 5 24 0 15 1 15 11 5 400 1 5 14 3 20 8 21 16 11 600 1 9 6 24 11 25 20 14 800 0 5 7 8 26 13 27 22 16 30 TABLE HOSPITALIZATION PARAMETERS FOR THERAPY PATIENTS WITH I 131 ACTIVITY ADMIT OR DISCHARGE 1100MBq Stay in hospital or discharge individual restriction 600MBq Discharge with individual restrictions 150MBq Discharge with general restrictions 31 INSTRUCTIONS TO OUT PATIENTS No eating and drinking during the first hour after treatment During the following two days drink more than usual Useonly a WC and flush 2 3 times Keep the toilet and the floor clean Wash your hands frequently and take a shower every day Avoid close contact with members of the family children and pregnant women according to the time table attached Avoid solid waste Contact the nuclear medicine department in case of problems or questions AVOIDING SOLID WASTE Do notuse paper plates or disposable cups or flatware Useregular dishes glasses and utensils Wash them in the sink or dishwasher Tissues and paper napkins should go in the toilet not in the garbage Food residues should be avoided during the first week apple cores chicken bones etc Articles contaminated with body fluids that cannot be washed clean or disposed offin the toilet should be stored for decay HOSPITALIZATION OF PATIENTS WITH I 131 The following instructions should be fulfilled Room f
21. d for radiological examinations for screening of large populations or for occupational legal or health insurance purposes 42 VIILIII OPTIMIZATION a Do medical practitioners ensure that appropriate equipment is used that the exposure of Yes No patients is the minimum necessary to achieve the diagnostic objective and that relevant information from previous examinations is taken into account to avoid unnecessary additional examinations b Do the medical practitioners the technologists or other imaging staff endeavour to Yes No achieve the minimum patient exposure consistent with acceptable image quality by i Appropriate selection of the radiopharmaceutical amp its activity noting special Yes No requirements for children and for patients with impaired organ functions ii Use of methods for blocking the uptake in organs not under study and for accelerated Yes No excretion when applicable iii Appropriate image acquisition and processing Yes No c Are radiological examinations causing exposure of women who are pregnant or likely to Yes No be pregnant avoided unless there are strong clinical reasons for such examinations d For lactating mothers is discontinuation of nursing recommended until the Yes No radiopharmaceutical is no longer secreted in an amount estimated to give an unacceptable dose to the nursing child e Is the administration of radionucli
22. des to children for diagnostic procedures carried out Yes No only if there are strong clinical indications and the amount of radioactivity is reduced according to body weight body surface area or other appropriate criteria VIILIV CALIBRATION a Is the calibration of sources used for medical exposure traceable to a standard dosimetry Yes No laboratory b Are unsealed sources calibrated in terms of activity of the radiopharmaceuticals to be Yes administered with the activity being determined and recorded atthe time of administration VIILV CLINICAL DOSIMETRY Are representative absorbed doses determined and documented Yes No VIIL VI QUALITY ASSURANCE Does the medical QA programme include a measurements and verification of physical parameters at the time of Procedures Yes No commissioning and periodically thereafter Followed Yes No b written records of relevant procedures and results Procedures Yes No Followed Yes No C verification of the appropriate calibration and conditions of operation of Procedures Yes No dosimetry and monitoring equipment Followed Yes No d verification of patient identity Procedures Yes No Followed Yes No regular and independent quality audit reviews Procedures Yes No Followed Yes No 43 VIILVII DOSE CONSTRAINTS a Does the dose constraints to be applied on case to case basis in the optimizat
23. dresses all administrative and technical parameters that are an integral part ofa comprehensive QA programme 4 GENERAL PRINCIPLES OF QUALITY ASSURANCE Three basic principles in a nuclear medicine department are 1 Improvement in the quality of diagnostic information ii Acquisition of desired results with minimum amount of radionuclide activity and iii Appropriate use ofavailable resources so that the facility can be upgraded to cope with the advance technology AQAProgram should include the following parameters I Physical parameters of the radiation generators imaging devices and irradiation installation at the time of commissioning and periodically thereafter ii Means for verification of the appropriate physical and clinical factors used for diagnosis and therapy iii Written records ofrelevant procedures amp results iv Verification of the appropriate calibration and conditions of operation of 5 2 We dosimetry and monitoring equipment and Regular and independent quality audit OPTIMIZATION OF QA Design of the Facility The design of the facility should take into consideration 1 ii iii The type of work and the radionuclides and their activities intended to be used Categorization of hazards to determine the special needs concerning ventilation plumbing materials used in walls floors and work benches The layout of a typical nuclear medicine department and building requir
24. e of workers Waste disposal Transportation e Package surveys e Package documentation Transfer receipt documents e Details of shipments dispatched Patient records and Patient discharge surveys for patients receiving radionuclide therapy 7 OCCUPATIONAL AND MEDICAL EXPOSURE Medical and occupational exposures are affected at the following levels ii iii iv Receipt and storage Preparation Administration of radiopharmaceuticals and Detection level Therefore QA protocols should address all these issues The nuclear medicine physician should therefore consider the following parameters in order to maintain QA in the field 1 Choice of examination ii Determination oftechnical parameters iii Optimization ofadministered activity iv Methods ofreducing the absorbed dose v QC ofequipment and radiopharmaceuticals vi QA of clinical procedures vii Safe routines to avoid misadministration 7 1 Radioactive Source Tracking Radioactive sources must be tracked from receipt to transfer or disposal in order to ensure accountability to identify when licensed material could be lost stolen or misplaced and to ensure that source activity limits authorized on the license are not exceeded 71 1 Package Opening The procedures for opening of packages must be maintained They must include visual inspection of the package and monitoring of external radiation levels and removable contami
25. edures carried out within the department b The manual should be reviewed and updated annually to accommodate new techniques c Administrative clinical and radiation safety aspects need to be defined separately d It should be signed by the Head ofthe radiation facility and head of nuclear medicine department e Itshould incorporate opinions ofall the concerned departments and f It should be accessible to all The administrative routines in a hospital clinical practice should include the following basic information 1 Required study ii Preparation ofthe patient iii Radiopharmaceuticals required iv Route ofadministration v Activity requested vi Type of examination required vil Views desired viii Scanning speed Ix Required collimator x Required window setting xi Positioning ofthe patient for that particular test and xii Presentation ofresults Efficient use of computers can increase the sensitivity and specificity of an examination To achieve this objective the facility administration must ensure that 1 Software based on published and clinically tested methods are used ii Well documented algorithms are used iii User manuals are available and iv Software phantoms are available It is the responsibility of the QA committee to formulate QC application protocols in order to 1 Analyze the program code ii Perform phantom studies iii Do simulated examinations iv Compare w
26. ements is given in Annexure I QA Program Organization It includes 1 ii iii iv vi vii viii Procedures The procedures include patient history signs and symptoms diagnosis appropriateness of investigation precautions to be taken and any contraindications etc Planning of procedures This means that the facility should have appropriately defined administrative procedures patient information system patient preparation areas etc Clinical procedures It means that procedures for the purchase of equipment radiopharmaceuticals etc are defined and only approved suppliers are listed In addition storage amp preparation of radiopharmaceuticals clinical environment patient handling amp preparation equipment acquisition and performance protocols and waste disposal procedures must be available All medical and paramedical staff in a nuclear medicine department should be qualified and have on the job training on radtiation protection Data analysis It means that processing protocols equipment performance data accuracy and integrity protocols must be established Report QA should also be maintained while acquiring data image review and results with further advice etc General outcome It means that the general outcome of a diagnostic or therapeutic procedure should be according to the satisfaction of the physician as well as the patient and Audit 5 3 Facility Organization It is advisable that the
27. es legible Yes No In local language Yes No iii Is there proper shielding e g individual containers enclosures Yes No the storage locations reserved only for radioactive material Yes No d Are supervised areas demarcated Yes No needed Yes No provided Yes No e Are approved signs at access points legible Yes No in local language Yes No 39 V II LOCAL RULES AND SUPERVISION a Are rules established in writing Yes No b Do rules include investigation levels and authorized levels and the procedure to be followed 3 Yes No when a level is exceeded c Are workers instructed in the implementing procedures Yes No d Do workers have adequate supervision to ensure rules procedures protective measures amp ites Yes No safety provisions are followed e Specifically are operating amp working procedures for provided Yes No i Nurses attending patients adequate Yes No ollowed Yes No provided Yes No ii Diagnostic examination adequate Yes No ollowed Yes No provided Yes No iii Therapy administration adequate Yes No ollowed Yes No provided Yes No iv Repairing and maintaining safety systems adequate Yes No ollowed Yes No provided Yes No v Making surveys adequate Yes No ollowed Yes No MONITORING a Does the authorized organization provide personal dosimeters Yes No
28. established at the workplace during the acceptance test and To estimate both short term changes in parameters and long term trends in their gradual changes The routine consistency tests can be distinguished between simple and complicated tests Simple Tests These tests utilize a low time frame and are easy to carry out in periods ranging from a few minutes to halfan hour which is very important with regard to the frequent use of the equipment especially the scintillation cameras Another important aspect of these tests is that they do not require much technical equipment and can be carried out by commonly available equipment which is usually not very expensive The institute itself is responsible to perform these tests by utilizing existing means b Complicated Tests The most important aspect of the complicated tests is that they require several hours for performance and much more specialized equipment is required or a combination of both The institution may not have the capability to perform these tests itself The institution must ask for assistance from the companies providing maintenance of medical equipment or make an agreement with a group of specialists in the field Another alternative is that while purchasing the equipment an agreement should be made with the supplier to include the complicated tests in the equipment warranty However an occasional consultation with an independent specialist in order to ensure the objectiv
29. his test should be done during the acceptance test and then once a year 25 TABLE 8 Summary of SPECT QC Tests GOOD PRACTICE DAILY ONE TWO WEEKS QUARTERLY Visual check of energy Extrinsic intrinsic High count density Point source spectrum Low count flood Intrinsic flood Reconstructed resolution Cine review of projection amp Intrinsic Extrinsic resolution Reconstructed SPECT optionally sonogram data check with bar or hole pattern Phantom Background Check Pixel size check Visual inspection of Center of rotation Tilt angle check collimators for damage rotating collimators 10 3 1 2 Surface contamination measurement device Response control test It is the value shown on the equipment when measuring the surface contamination ofa known value expressed in Bq cm The equipment s response to the surface source of a given radionuclide must not differ by more than 1096 from its detected surface activity This test should be done during the acceptance test and then once a year 11 EDUCATION AND TRAINING Itis the responsibility of the licensee to ensure that All persons responsible for protection and safety are appropriately trained and qualified so that they understand their responsibilities and perform their duties with appropriate judgement and according to defined procedures especially physicians medical physicist nuclear medicine technician RPO Outside contractors on whom radiat
30. ing e Draw the required volume and measure the activity Dispense the radionuclide into a shielded syringe bench top shield vial shield syringe shield e Keep the vial in fume hood and on a tray with lips lined with plastic backed absorbent pads e Handle the vial with forceps or similar long handled instruments Put the radionuclide in an infusion bottle Line the bottle to the patient using an intravenous catheter e Keep the patient in bed until the bottle is empty Cover the vial with lead after use e Check the activity e Remove the bottle and catheter or syringe and dispose them off as 10 8 5 11 radioactive waste Document each step Administration of Radiopharmaceuticals According to the Regulations on Radiation protection PAK 904 unsealed sources for nuclear medicine procedures should be calibrated in terms of activity of the radiopharmaceutical to be administered the activity being determined and recorded at the time of administration The following information must be fulfilled prior to injecting radiopharmaceuticals Patient name Patient identification number preferably it should include National Identity Card number as well History of pregnancy and breast feeding from female patients Check the request form it should be signed by the nuclear medicine physician Check the label of the syringe Annexure describes safe administration of I 13 1 and
31. ion of Yes No protection for persons exposed for medical research purposes specified if such medical exposure does not produce direct benefit to the exposed individual b Have dose constraints been established for individuals knowingly exposed while voluntarily Yes No helping in the care or comfort of patients undergoing medical diagnosis INVESTIGATION OF ACCIDENTAL MEDICAL EXPOSURE 8 Did the registrant or licensee promptly investigate any or all instances where Yes No i a diagnostic dose was substantially greater than intended or resulting in doses repeatedly and substantially exceeding guidance levels Yes No ii there was an equipment failure accident error mishap or other unusual occurrence with the potential for causing a patient exposure significantly different from that intended Yes No b With respectto any incidents investigated did the registrant or licensee Yes No i calculate or estimate the doses received and their distribution within the patient Yes No ii indicate the corrective measures required to prevent recurrence of such an incident Yes No iii implement all corrective measures that were under their control Yes No iv submit a written report to PNRA as soon as possible stating the cause of the accident the dose received and the corrective measures taken to avoid a recurrence Yes No v inform the patient and his attending physician about the incident Yes No
32. ion protection may depend e g service engineers are appropriately trained and qualified RPO should give instructions to Nurses in wards with radioactive patients Staff who do not belong to the nuclear medicine practice but need to enter controlled areas Staff who transport radioactive patients Basic and continuing training 1s received by the persons who have the responsibility for the operation of the equipment or for preparation of radiopharmaceuticals Advanced training for physicians physicists and radiopharmacists is available All staffhave regular updates on radiation protection aspects and Education and training records are maintained with the following information 26 Name ofthe person who received the education training Name ofthe person who delivered the education training Date and duration ofthe programme Syllabus ofthe training Copy ofthe certificates ofthe training Annexure IV is the checklist for the inspectors of inspection of a nuclear medicine department 27 ANNEXURE I LAYOUT OF A NUCLEAR MEDICINE DEPARTMENT sy B on Se D as 4 SEE ENCLOSURE PATIENTS IN INO b5 FOR PHYSICISTS COMPUTER WAITING RIA COUNTING a SAMPLE TECHNICIAN COLLECTION POST ADUN GAMMA CAMERA amp HANDLING 1 WAITING D D Ww T aaah ne v7 T5 NTRANCE CORRIDOR From high to low activity D D 5 L5 PHY
33. ith the reference normal data and v Ensure clinical evaluation The Diagnostic Report should include i Patient identification ii Date amp type of study iii Radiopharmaceuticals used and it s activity iv Study results v Description of findings Vil Diagnostic conclusions and Recommendations Records Maintenance of records is an integral part of QA The records to be kept include i ii iii iv V vi Vil viii Ix X xil xiii XIV xv xvi xvii Authorization certificate license and documentation supporting the corresponding application Records ofany correspondence between the licensee and the Authority Name s of the person s authorized and responsible for the radiation protection programme Individual doses current and prior work history Results ofarea surveys Equipment and instrument QC tests and calibration Inventory ofunsealed and sealed sources Incidents and accidents investigation reports Audits and reviews ofthe radiation safety programme Installation maintenance and repair work Facility modification Training provided initial and continuing including the following information e Name ofthe person s who delivered the training e Name of the person s who received the training e Date and duration of the training e List of the topics addressed e Copy ofthe certificates of the training Evidence of health surveillanc
34. itle Telephone number Fax number Mailing address E mail address 34 4 PROPOSED DATE OF INSTALLATION amp OR COMMISSIONING OF FACILITY amp EQUIPMENT II SOURCES ILI DETAILS OF RADIONUCLIDES INVOLVED RADIONUCLIDE Maximum activity at one Physical Chemical form Use Application e g PHARMACEUTICAL time Bq e g 37GBq e g Sodium Diagnostic Imaging e g Generator pertechnetate CONTAINMENT OF THE RADIONUCLIDES nitial containment Any special features e g whether the container is pressurized or incorporate shielding ILIII WORK PATTERN Frequency of consignments ofradionuclides ILIV WORK LOCATIONS Will the work be carried out at any address other than Do not know Yes No those given 1 List all other known addresses ILV RADIOACTIVE WASTE Indicate whether the work involved is likely to generate radioactive waste If YES then provide an assessment ofthe different forms Radionuclide e g l Waste form liquid Maximum activity Proposed disposal route 125 TC used syringes 10KBq To drain 2MBq Decay storage 35 III FACILITIES AND EQUIPMENT IILI FACILITY SPECIFICATIONS Detailed description ofthe location Layout of the laboratory clearly indicating storage areas of radioisotopes TC generator amp radiopharmaceuticals dose administration co
35. ity of such tests 1s nevertheless required Another important parameter of the QC tests is preventive maintenance of the equipment examination cleaning and changing of used parts this helps to prevent sudden problems that affect the regular clinical operation c Analysis of Results The results of acceptance and routine tests must be recorded carefully and for this purpose special records must be kept for every piece of equipment It is important to emphasize that the licensee when assuring the quality of the equipment technology must strictly follow the instruction of the supplier or the manufacturer listed in the accompanying directions and documentation 10 2 Equipment Used in Nuclear Medicine The following equipmentis listed in the QA programme l Equipment measuring activity of radiopharmaceuticals calibrators 2 Single detector equipment for measuring in vitro and in vivo for unscintigraphic examination and multiple detector equipment for measuring in vitro 17 3 Imaging equipment scintillation planar cameras scintillation cameras for one photon emission tomography SPECT 4 Equipment for safety dosimetry measuring equipment for input sources surface contamination operation dosimeters Control of the quality of the activity measuring instruments calibrators with a well ionizing chamber The consistency tests for calibrators are summarized as e SIMPLE gt Background gt Stabi
36. l Purity and Content In general chemical impurities in radiopharmaceuticals are objectionable only if they are toxic or if they interfere or result in the modification of the desired study 8 24 pH The pH of radiopharmaceutical injections and solutions should be within specified range 8 25 Specific Activity Control of specific activity is particularly important in exchange radio labeling e g inthe labeling of an iodo compound by exchange with 1231 or 1311 8 3 Preparation of Radiopharmaceuticals The following criteria need to be fulfilled Written procedures must be followed in preparation to ensure safe handling of radiopharmaceuticals e Transparent vial shields should be used e unique code must be followed which can be able to trace the original components in the preparation e Labeling of vials and syringes must be ensured e The activity should be measured e Protective clothing must be available Toolsforremote handling ofradioactive material must be available Containers for radioactive waste are available Dose rate monitor with alarm should be there The department should have contamination monitor e Adecontamination kit must be readily available Appropriate warning signs and labels must be available Records of radionuclides kits etc must be maintained 8 4 Dispensing Radiopharmaceuticals The following steps must be followed e Check the kit amp vial shield labels before dispens
37. lity short term reproducibility COMPLICATED gt Long term reproducibility gt Calibration measuring accuracy gt Linearity gt Measuring geometry Overview of activity tests calibrators with the ionizing well chamber and frequency of their application is shown in the table 2 The licensee bears the responsibility of accuracy of radionuclide calibrator As all calibrators show some dependence on measurement geometry that diminishes with increasing depth of the well the nuclear medicine units will ensure that tables giving correction factors are applied in measurements on different radionuclides in syringes vials amp other containers of different sizes amp types are being provided The records of QC tests must be maintained and provided to the Authority Inspectors on demand at the time of inspection A full quality control report by a qualified medical physicist needs to be submitted to the Regulatory Authority annually TABLE 2 Activity Tests with Ionizing Well Chamber amp Their Frequency FREQUENCY TEST TYPE ACCEPTANCE TEST DAILY ONCE PER YEAR Background x x Simple Stability x x shortterm reproducibility Longterm reproducibility x x Calibration x x measuring accuracy Complicated Linearity x x Measuring geometry X x 99m Diagnostic nuclear medicine departments that use a Mo Tc generator or 18 prepare their own dosages are requi
38. nation if the package is damaged verification that the contents confirm with the packing slip and with the purchase order and monitoring of the packing material and empty package For further details PNRA Guidelines on Radiation Safety and Regulatory Requirements for Nuclear Medicine Facilities may be consulted 71 2 Checkof Sources The procedures should include provision for safe handling of sources and the verification of activity 71 3 Storage Procedures should include the use of appropriate shielding choice of an appropriate location and a check of the external dose rate to verify that it does not exceed the limits specified Radiation level limits for various labeled packages are given in table For storage of radionuclides like 131 the following precautions should be followed It should be stored in a controlled area e It should always be stored in a lead container and preferably in fume hood or refrigerator to prevent evaporation and e Inorder to reach an acceptable external dose rate 1 4 cm thick lead shield is required Table 1 Radiation Level Limits for Labeled Packages TRANSPORT INDEX TI MAXIMUM RADIATION LEVEL AT ANY POINT ON CATEGORY EXTERNAL SURFACE 0 Not more than 0 005mSv h White More than 0 but not more More than 0 005mSv h but not more than 0 5mSv h Yellow 11 than 1 More than 1 but not more More than 0 5 mSv h but not more than 2 mSv h Yellow
39. nts Document any significant differences and any agreed upon plan to resolve the different results 41 VII EMERGENCY PREPAREDNESS VILI EMERGENCY PLAN Is there a written plan Yes No b Is the plan periodically reviewed and updated Yes No c Does the plan take into account lessons learned from operating experience and accidents Yes No at similar facilities VILII TRAINING AND EXERCISE a Have workers involved in implementing the plan received training Yes No b Have provisions been made for the plan to be rehearsed at suitable intervals in conjunction Yes No with any designated emergency response authorities C Date ofthe last rehearsal Yes No VIII VERIFICATION OF MEDICAL EXPOSURE VIILI RESPONSIBILITIES 8 Is no patient treated unless the exposure is prescribed by a Procedures Yes No medical professional Followed Yes No b Are there an adequate number of trained medical and paramedical personnel to discharge Yes No assigned tasks C Are diagnostic imaging amp QA requirements fulfilled with the advice of a qualified expert in Yes No nuclear medicine physics VIILII JUSTIFICATION a Are diagnostic medical exposures justified by taking into account the benefits and risks of Yes No alternative techniques that do not involve medical exposure Yes No b Are standards available and followe
40. o the baseline acquired with the same radionuclide Tilt Angle of the Camera Head s For best results in SPECT the detector head must be parallel to the axis of rotation level For manually positioned systems this must be verified at every acquisition but even systems with motorized tilt angles need to be checked periodically Verify that a level detector corresponds to a tilt indication of zero at different radii of rotation A change in indicated value will be indicative of mechanical problems Reconstructed Point Source Resolution Features to look for in the 24 reconstructed image are width in all three dimensions shape amp presence of streaking or other artifacts This test can conveniently be carried out at the same time as a COR test using the same point source An offset point source will provide more information about camera performance than a source on axis but when combining this test with the COR test follow manufacturers recommendations vi Reconstructed Cylindrical Phantom Uniformity A frequency of once a month is recommended This test will uncover any angular variations in camera performance that have not been picked up by other tests vi SPECT Resolution amp Uniformity Phantom Test This test is recommended for QC purposes When performed using the recommended phantom and when acquired correctly the analysis of the results of this test provides information on the complete SPECT imaging system bo
41. ods of maintenance iii 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 again iv Provision of a service contract covering preventive maintenance particularly when equipment parts amp expertise are provided by the manufacturer and Maintenance of a service record during the lifetime of equipment for a duration specified by the Authority 14 15 Purchase Specifications The following parameters must be considered prior to purchasing any equipment 1 ll lii iv V vl vil Vili ix System overview Contact persons Commercial specifications Technical specifications Data acquisition and processing Electrical and mechanical safety parameters according to National Radiation Protection Regulations Education and training Documentation Service organization and Installation and acceptance testing The vendor should specify the following before the final deal of gamma camera Hardware 1 ii iii iv V vi vii viii D X xii xiii Crystal size amp shape PM Tube Gantry dimension amp weight Gantry movements including auto contour Electrical power requirements Imaging table Collimators and method of change Shielding of detector Operating cons
42. ole Emergency window Energy range Safety features and Motion control Technical performance 1 ii iii iv Vi Vil viii 1X Linearity Uniformity different energies different angles Energy resolution Spatial resolution intrinsic amp system planar amp tomographic Count rate performance Centre of rotation Multiple window spatial positioning System sensitivity planar and tomographic and Point source sensitivity Computer System I ii iii Acquisition modes Basic application programmes Clinical application programmes iv DICOM Standards Network amp communication Vi Printers Vil Storage amp back up of patient data Vill User lists and site visits Ix Reliability X Service response time amp follow up Xi Training xii Service manuals xiii Upgradability XIV Delivery setup amp installation date XV Floor loading elevators and doors and xvi Electrical requirements After the vendor has clarified all the above requirements QC of equipment will be performed as follows Acceptance Tests It is the measurement to judge whether instrumentation comply with its specification as mentioned in manual Before the equipment is introduced to its regular use after installation it is important to check whether its detection parameters correspond to those as specified by the manufacturer in the accompanying documentation Acceptance
43. or Iodine therapy is a controlled area Only one patient should be in the room The room should have easily cleanable surfaces and utensils Extra lead shields should be used The door should be kept locked Radiation warning signs should be posted on the door Visitors should be restricted Decontamination equipment should be easily available The medical physicist should monitor the activity levels before the patient 1s being discharged ASKETCH OFA ROOM FOR PATIENTS ADMITTED Lead protected L shaped shietd Patient s Window toitet Radiation survey monitor Ventilated cupboard Outer wall of hospital shield Waste disposal container Lead shield Wall to corridor PATIENT INSTRUCTIONS e Stayintheroom Drinkas muchas possible e slices e Use only the private toilet and flush 3 times Men should sit down to avoid splashing e Wash hands well in soapy water after using toilet e Wear footwear when leaving the bed e Inevent of vomiting or incontinence notify the nurse immediately INSTRUCTIONS TO NURSING STAFF e Reduce time spent with patient by planning ahead and working efficiently Workas far from patient as possible e Practice preventative measures against contamination wearimpermeable protection gloves wear shoe covers wearaprotective gown e Remove protection clothing before leaving the room
44. ord ofall these measures must be kept The transportation of sources and radiopharmaceutical are subject to the Regulations for the Safe Transport of Radioactive Material Pak 916 8 RADIOPHARMACEUTICALS In nuclear medicine it is desirable to use relatively short lived agents which can be delivered to hospitals amp clinics from commercial sources The nuclear medicine department needs to have a qualified radiopharmacist or a radiochemist The following are the responsibilities of a radiopharmacist radiochemist 99m Elution of sterile pertechnetate from a Mo Tc generator Preparation of radiopharmaceuticals according to manufacturer s instructions Performance of quality control procedures on the prepared radiopharmaceuticals If a radiopharmacist radiochemist is not available the nuclear medicine technologist is responsible to carry out these additional responsibilities 8 1 Radionuclide Generators The most important generator is the Mo system Commercial generator systems are autoclaved amp the elution dynamics quality controlled before shipment However each laboratory must perform quality control steps each time the generator is eluted 8 1 1 Radionuclide Purity The only desired radionuclide in the Mo Tc generator eluate is Tc Any other radionuclide in the sample is considered an impurity The amount of Mo in the eluate is subject to limits amp must be tested on each elution
45. port to Regulations on Radiation protection PAK 904 and Regulations for Licensing of Radiation Facilities other than Nuclear Installations PAK 908 Nuclear medicine has three major concerns efficacy quality of life and safety An integrated QA approach taking into account medical physical and radiation safety aspects can improve nuclear medicine in achieving adequate image quality at the lowest reasonable doses to the patients The responsibility of QA QC lies with the licensee user However this guide provides an outline of a QA programme which encompasses the overall QA of a nuclear medicine facility In the light of this guide the user may develop their respective QA QC protocols For further reference Guidelines on Radiation Safety and Regulatory Requirements for Nuclear Medicine Facilities can be consulted The Authority in this guide means Pakistan Nuclear Regulatory Authority 2 OBJECTIVE The objective is to provide a baseline to the licensee for the establishment of a comprehensive QA programme to ensure radiation protection and safety so that all necessary procedures are developed and implemented according to Radiation Protection Regulations PAK 904 within the country 3 SCOPE The scope ofthe guide is to address all areas in a nuclear medicine department where QA protocols are essential for ensuring radiation protection and safety It includes not only QA ofthe instruments and radiopharmaceuticals but also ad
46. portant for good SPECT quality ll Daily Tests the core of the QC programme 21 lil Less Frequent Tests tests to be performed on some regular schedule other than daily Table 7 indicates tests for SPECT QC TABLE 5 General Gamma Camera QC PARAMETERS COMMENTS DAILY Uniformity Check Flood field intrinsic without collimator or extrinsic with collimator Window setting Confirm energy window setting relative to photopeak for each radionuclide used WEEKLY Spatial Resolution Requires resolution phantom PLES four quadrants bar orthogonal hole amp standardized protocol Linearity Check Qualitative assessment of bar pattern linearity PERIODICALLY Biannually or when a problem is suspected Collimator Performance High countflood with each collimator Energy Registration For cameras with capability of imaging multiple energy windows simultaneously Count Rate Performance amp Count Rate Linearity More important in cameras with count skimming or count addition correction circuitry Energy Resolution Easiest in cameras with built in multichannel analyzer Sensitivity Countrate performance per unit of activity TABLE 6 Duties of the Personnel for QC of Gamma Camera TEST ACCEPTANCE DAILY WEEKLY YEARLY Uniformity P amp T T P Uniformity tomography P P Spectrum display P amp T T
47. rable Choice of equipment depends upon 1 Type of procedures to be undertaken il Technical specifications 13 iil Manufacturer e Availability of spare parts e Service and maintenance availability e Userand service manual e Education and training iv Local user e Service and maintenance e Education and experience of the staff e Siting of the instrument Ease reliability and safety in operation and Vi cost Siting of equipment The following factors must be looked for before the installation of the equipment 1 The space of the room should be sufficient ii Electrical power supply must be smooth without any interruptions iii Environmental factors temperature humidity air pollution must be taken into consideration iv Structural shielding requirements according to the specifications of the Radiation Protection Regulations PAK 904 must be fulfilled and v The level of background radiation levels must be taken into account Maintenance Regular maintenance is required for 1 Increased availability of equipment ii Increased quality by better performance iii Increased safety and iv Increased lifetime ofequipment Maintenance procedures should include consideration ofthe following i Overall management amp the maintenance programme This is provided by the medical physicist in co operation with the RPO ii Measures to prevent use of equipment during peri
48. raining of workers Yes No 9 Does the RPO maintain adequate records to demonstrate worker amp public protection Yes No 3 Procedures Yes No h Are there provisions for inventory of sources amp accountability Performed Yes No 1 Are there provisions for audits and reviews of radiation safety Procedures Yes No programme Performed Yes No 38 IV VUI INVESTIGATION amp QA a Were there any incidents or accidents Yes No b If so were incident and accident investigation reports prepared Yes No c Were safety assessments reviewed or made on the basis of lessons learned from Yes No any incident or accident at similar facilities 2 d Is there a written QA programme E b Ue Is maintenance amp repair work of measuring equipment Scheduled Yes No imaging devices ventilation systems etc in accordance Performed Yes No with manufacturer s recommendations Pi f Are repair maintenance procedures PE 4 Ne V VERIFICATION OF WORKER PROTECTION V I CLASSIFICATION OF AREAS Are controlled areas demarcated Yes No provided Yes No b Are approved signs at access points legible Yes No In local language Yes No Is radioactive material storage including waste at physically defined locations Yes No i Is there a locked secured location with key control Yes No provided Yes No ii Are radiation warning signs notic
49. red to determine amp record the activity of each dosage before medical use by direct measurement In this case a dose calibrator must be employed for the activity determination and required record keeping as follows l Mo activity present in any Tc preparation must be determined It must be lt 0 15uCi Mo mCi Tc 0 15kBq Mo MBq Tc If this activity ratio is exceeded the dosage cannot be administered 99m 21 Mo concentration of the first eluate after receipt ofa Mo Tc generator must be measured and recorded 3 The dose calibrator must be calibrated and the results recorded Personnel must be familiar with proper operation of the dose calibrator amp know what actions to take in the event ofa non functional calibrator Quality control of detecting equipment for in vitro during experiment and in vivo in living things measuring equipment without scintigraphy Table 3 enlists the recommended QC tests for a calibrator One detector amp two detector equipment Consistency tests of equipment in vivo and in vitro can be summarized as follows Table 3 Test schedule for Radionuclide Calibrator FREQUENCY IN No TEST ACCEPTANCE REFERENCE ROUTINE TESTING gt Acceptance amp S m Reference Tests E D 8 1 Physical Inspection x 2 Test of precision amp x x x accuracy 3 Test of linearity of activity x x x response 4 Test of background x x x response OPERA
50. roduction under a procedure according to a clearly written protocol lil The results ofthe controls including the conditions under which these results have been measured must be carefully documented lv As an element of the controls it must also be described what must be done in case the measurements are not satisfactory from the point of view ofthe established criteria QA is essential not only for maintaining high standards of clinical practice but also for maintaining high performance of equipment In each department there should be a continuous review process to monitor clinical and equipment performance in accordance with national and international standards There should also be routines and a policy for purchasing equipment 10 1 Equipment Purchase Rules It is the responsibility of the hospital management to clearly define a policy for purchasing new equipment The facility administration should constitute a purchase group comprising of the following 1 Nuclear Medicine Specialist il Medical Physicist ill Nuclear Medicine Technologist iv An Engineer person with authority from administration The need to purchase new equipment depends upon 1 Starting a new diagnostic facility il Increased workload of the patient iii The technical performance is deteriorated iv The equipment performance is not good enough for new techniques methods V Spare parts are not available and vi Un repai
51. should be performed daily amp whenever collimators are changed Signs of denting scratches or stains should be followed with an extrinsic flood test amp a background check before a suspect collimator is used for patient imaging LESS FREQUENT TESTS 1 ii Resolution Phantoms Using a four quadrant bar pattern or some other repetitive pattern such as holes resolution amp linearity of the entire surface of the camera can be judged Compare the results with the reference image identically acquired at the time of known performance Loss of resolution may indicate electronic noise or degradation of crystal or interface Center of Rotation COR Test COR testing should be performed as per recommended schedule of the manufacturer It is recommended that COR testing be performed routinely on all collimators used for SPECT Variable angle cameras should be checked for both the 90 amp 180 degree positions unless otherwise stated by the manufacturer It is a good practice to look at per view deviations from expected source positions which can indicate problems with mechanical alignment It is desirable to rotate collimators systematically for the purpose of this test so that a different collimator or collimator set is used for performing the test until all SPECT collimators have been tested TABLE 7 Tests for SPECT QC z 8 qo z 2 2 pA 2 x E 8
52. t 9 8 2 Radiopharmaceutical Behavior sse 9 8 2 1 Radionuclide Purity 8 2 2 Radiochemical Purity 8 2 3 Chemical Purity and Content 8 25 JSpDeOHMICUACBVIEy oeste metier ere em epp Ordres 8 3 Preparation of Radiopharmaceuticals sess 10 8 4 Dispensing 5 10 8 5 Administration of Radiopharmaceuticals sss 11 9 WORK IN A CONTROLLED AREA sesssessessesssesoessoescesessscesoesossseesessesee 11 10 13 10 1 Equipment Purchase Rules sese 13 10 2 Equipment Used in Nuclear 2 17 10 3 Quality Control of Imaging Systems Scintillation Cameras 21 10 3 1 QA of Equipment for Safety Dosimetry sss 25 11 EDUCATION AND 00 26 ANNEXURE Di E 28 ANNE QUU E 30 ENWRIOQUINEII m saosa 34 QUALITY ASSURANCE IN NUCLEAR MEDICINE ABSTRACT Pursuant to the requirements of the Regulations on Radiation Protection PAK 904 and Regulations for Licensing of Radiation Facilities other than Nuclear Installation s PAK 908 this document describes the parameters of quality assurance in nuclear medicine department They should be fulfilled by the users prior to issuance of a license 1 INTRODUCTION This guide is prepared in sup
53. tc This is required to determine whether the activities conducted to obtain images of good quality are consistent with the current good medical practice and are carried out in a safe manner ADMINISTRATIVE ROUTINES An appropriate administrative routine is an important part of a QA program This ii iii iv vi vii includes patient identification patient information type of study and justification of the request selection of examination protocols diagnostic reports and records Following criteria must be followed The request of a nuclear medicine examination must be from a nuclear medicine specialist Any request ofnuclear medicine examination advised by a physician outside the facility should be justified and evaluated by the nuclear medicine specialist Nuclear medicine specialist of the facility should communicate with the referring physician Special consideration should be given to children and pregnant women Patient identification should follow the hospital routines A proper system of identification will prevent examination or treatment of the wrong patient Every request must include patient identity information about the desired examination any required pre medication any contraindications and waiting for the examination Itis recommended that a procedure manual is made available for each type of examination This manual should have a Clear and concise statements of all the policies and proc
54. tests are also important after any considerable maintenance on the equipment The aim ofthe acceptance tests is To compare the measured values of parameters with the values specified by the manufacturer To control all parameters and features of the equipment that can influence the outcomes of measurements especially in case of scintillation cameras and To obtain a basis for performing consistency routine tests during the use of the equipment at a workplace The way the acceptance test is carried out and all criteria used in the test must be declared in the contract with the manufacturer In this regard one of the following options can be selected The supplier ofthe equipment himself carries out acceptance tests at the workplace where the equipment is installed in the presence of a specialist a physician medical physicist or a technician of the facility They are carried out by qualified persons i e employees of the institution buying the equipment and The supplier and the purchasing institute make an agreement that independent specialist will carry out the tests Routine Consistency Tests When the acceptance testing has been completed satisfactorily their results will provide a baseline data for carrying out routine consistency checks The aim of consistency routine tests is 16 To check whether the measured values of the parameters are within the recommended tolerance range of parameters
55. th hardware amp software This test may not specifically indicate the source of an error but when used routinely it provides a valuable trend analysis of total system performance It is recommended that this phantom test be acquired initially at system acceptance and then quarterly thereafter Results of all subsequent acquisitions should be compared to the baseline acceptance study and viii Pixel Size Pixel size is another parameter that affects SPECT image quality amp quantization This should be monitored more frequently in older SPECT systems The newer digital cameras should be tested initially upon acceptance amp then every six months thereafter following manufacturers instructions Table No 8 outlines a summary of recommended SPECT QC Tests The tests outlined are not performance tests rather the outcome of these tests is expected to change as the system performance changes It is therefore important to establish a baseline as an indication of system degradation Acquisition parameters as well as acceptable deviations will be based on individual manufacturer s recommendations 10 3 1 QAof Equipment for Safety Dosimetry 10 3 1 1 Dose and Dose Rate Measuring Device Response control test It is the value shown on the equipment when measuring the dose and the dose rate of a known value in the photon radiation field gamma amp roentgen radiation The measured value of the dose must not differ by 20 from the standard value T
56. tive waste bin as soon as work with radioactive substances is finished To minimize the hazard from external radiation Sources must be kept within suitable lead shielding when not in use Vials of activity should only be removed from their lead pots when this is absolutely necessary e g place in the ionization chamber Unshielded vials ofactivity should only be manipulated with long handled tongs Syringes containing radioactivity should be fitted with lead syringe shields whenever possible Patient doses should be kept in the shielded storage area until required Unused doses should be returned to the radionuclide lab at the end of each session and Personnel should keep as far away as possible from all sources and organize work so as to minimize the time spent in close proximity to large sources e g stand back while the Tc generator is eluting 12 10 INSTRUMENTATION The aim of the QA program for equipment used in nuclear medicine is the prediction or identification of significant changes in technical parameters that could result in a lower or otherwise unsustainable quality of diagnostic and therapeutic results To make sure that the equipment is working correctly the following conditions must be fulfilled 1 Controls within the quality assurance system must carried out with suitable frequency some daily others over longer time intervals il Controls must be carried out with sufficient accuracy and rep
57. unting and imaging rooms and wards for thyroid cancer patients Layout of the drainage ducts systems such as sinks wash basins toilets etc should be connected directly to the sanitary sewage system Drawing of the facilities or a detailed sketch including wall amp ceiling materials amp thicknesses Any specific features designated to limit the spread of surface or airborne contamination Proposed category of the facility EQUIPMENT SPECIFICATIONS Manufacturer s specifications for any imaging equipment to be used Manufacturer s specifications and type approval certificate for radiopharmaceuticals dose measuring or calibrating equipment Proposed arrangements for restricting exposure including o Shielding provided to minimize external doses including vial amp syringe shields Forms of extract ventilation to minimize the risk of internal doses to staff Readily available accessible decontamination facilities Personal protective equipment provided Description ofany remote handling equipment ooo Oo IV VERIFICATION OF SAFETY IV I DESCRIPTION OF RADIONUCLIDES INVOLVED Radionuclide Maximum activity at one Physical Chemical form Use Application e g pharmaceuticaL time Bq e g 37GBq e g Sodium Diagnostic Imaging e g Generator pertechnetate 36 DESCRIPTION OF MEASURING amp HANDLING EQUIPMENT TYPE OF EQUIPMENT MANUFA
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