Quality Assurance IAEA   Training Material Radiation Protection  in Nuclear Medicine
OBJECTIVE To become familiar with the concepts of Quality Assurance in radiation protection in nuclear medicine and proced...
Content <ul><li>General principles </li></ul><ul><li>Organization of QA </li></ul><ul><li>Administrative routines </li></u...
Part 9. Quality Assurance Module 9.1. General principles IAEA  Training  Material  on  Radiation Protection  in Nuclear Me...
BSS 2.29. Quality assurance programmes shall be established that provide, as appropriate: a) adequate assurance that the s...
Meaning for medical  exposure that: II.22.  Registrants and licensees shall establish a comprehensive quality assurance pr...
QA-PROGRAMME OBJECTIVES <ul><li>Improvement in the quality of the  </li></ul><ul><li>diagnostic information. </li></ul><ul...
BSS II.23. Quality assurance programmes for medical exposures  shall include: a) measurements of the physical parameters o...
QUALITY ASSURANCE (definition) ” all those planned and systematic actions necessary to provide adequate confidence that a ...
QA and QC <ul><li>Quality Assurance is the overall process which is supported by Quality Control activities </li></ul><ul>...
QUALITY Quality of a practice is to fulfil the expectations and demands from: Patient Clinician Yourself
QUALITY ASSURANCE Protection Safety OVERALL QUALITY Diagnostics Therapy
QUALITY DEFINE OBJECTIVES How many times should the nurse be allowed to drop the child? What is an acceptable sens- itivit...
NUCLEAR MEDICINE SERVICE Primary  service Secondary service Nuclear medicine examination or treatment facilities patient c...
QUALITY ASSESSMENT Communication with the  client (patient, clinician). Expectations Acceptable level Reality
Clinical problem <ul><ul><ul><li>Radiopharmaceutical  Instrumentation </li></ul></ul></ul>Diagnosis and therapy with unsea...
QUALITY ASSURANCE PROGRAMME A  quality assurance programme in nuclear medicine should ideally include: Procedure  (i.e pat...
Module 9.2. Organization Part 9. Quality Assurance IAEA  Training  Material  on  Radiation Protection  in Nuclear Medicine
ORGANIZATIONS International bodies Recommendations. Interlaboratory comparison programmes. Education and training. Nationa...
LOCAL ORGANIZATION Hospital manager (licensee) QA committee QA-group nuclear medicine (chief technician, physicist, physic...
QA Committee Membership <ul><li>Must represent the many disciplines within the department </li></ul><ul><li>Should be chai...
Quality Assurance Committee <ul><li>Should ‘represent’ the department </li></ul><ul><li>Should be ‘visible’ AND accessible...
Module 9.3. Administrative routines Part 9. Quality Assurance IAEA  Training  Material  on  Radiation Protection  in Nucle...
ADMINISTRATIVE ROUTINES Request Patient id  and care Computer evaluation Diagnostic report Examination Method
REQUEST It is the responsibility of the  nuclear medicine specialist that the study requested by the referring physician i...
PATIENT <ul><li>Identification of the patient </li></ul><ul><li>Information about the examination </li></ul><ul><li>includ...
YOUNG PATIENTS ..should also be informed and motivated
PATIENT MOVEMENT
PATIENT MOVEMENT moving moving moving
Policies and Procedures Manual <ul><li>Reviewed (typically) yearly </li></ul><ul><li>This manual contains clear and concis...
Policies and Procedures Manual <ul><li>As a minimum, sections should exist for </li></ul><ul><ul><li>Administrative proced...
Policies and Procedures Manual <ul><li>It must be “signed off” by the Head of Department and appropriate section heads </l...
METHODS Methods should be in accordance with accepted practices Study name: Bone scan Preparation of patient: Empty bladde...
METHODS Static?  Tomographic? Dynamic?
METHODS Tl-201  Tc-99m 25 mSv  8 mSv
QUALITY ASSURANCE COMPUTER EVALUATION <ul><li>Efficient use of computers can  </li></ul><ul><li>increase the sensitivity a...
<ul><li>Analysis of the programme code </li></ul><ul><li>Phantom studies </li></ul><ul><li>Simulated examinations </li></u...
Bone scan phantom
Thyroid phantom
 
DIAGNOSTIC REPORT Patient identification Date and type of study Radiopharmaceutical and activity Study results - e.g. a gr...
QUALITY ASSURANCE METHOD Patient follow-up. Correlation with other available surgical, pathological, clinical and anatomic...
Society of Nuclear Medicine Procedure Guideline for General Imaging The final judge of any analytical method is a clinical...
RECORDS <ul><li>Authorization certificate and documentation supporting the corresponding application, and also any corresp...
RECORDS (cont) <ul><li>Training provided (initial and continuing), including the following information: </li></ul><ul><li>...
Module 9.4. Occupational and medical exposure Part 9. Quality Assurance IAEA  Training  Material  on  Radiation Protection...
EXAMINATION Request Patient id  and care Computer Evaluation Diagnostic report Examination Method
Patient The patient shall always be confident that a nuclear medicine examination and therapy is performed correctly and w...
Medical exposure <ul><li>Choice of examination </li></ul><ul><li>Determination of technical parameters </li></ul><ul><li>O...
Factors affecting medical and occupational exposure Receipt and storage Preparation Contamination Radioactive waste Detect...
QUALITY CONTROL RADIOPHARMACEUTICALS <ul><li>Radionuclide purity (other radionuclides?) </li></ul><ul><li>Radiochemical pu...
QUALITY ASSURANCE RADIOPHARMACEUTICALS <ul><li>Quality control of radiopharmaceuticals. </li></ul><ul><li>Written and trai...
PREPARATION OF RADIOPHARMACEUTICALS Tc99m-MDP 2237  5 447  SC 1997-09-28  7.40 <ul><li>Use a transparent vial shield </li>...
DISPENSING RADIOPHARMACEUTICALS Tc99m-MDP 400 MBq 400928-3336 1997-09-28 07.45 SC <ul><li>Check kit and vial shield label ...
INJECTING RADIOPHARMACEUTICALS <ul><li>Patient name? </li></ul><ul><li>Patient identification number? </li></ul><ul><li>Pr...
Worker The worker should always feel confident that he/she has the necessary training in order to perform his/her duty. Th...
FACTORS AFFECTING QUALITY <ul><li>Design of facility </li></ul><ul><li>Safe receipt and storage of unsealed sources </li><...
EDUCATION OF STAFF Correct use of equipment Close  15 cm  Wrong setting   of energy window
Module 9.5. Instrumentation Part 9. Quality Assurance IAEA  Training  Material  on  Radiation Protection  in Nuclear Medic...
How to get a new Gamma camera? Step 1
PURCHASE GROUP <ul><li>Nuclear medicine specialist </li></ul><ul><li>Nuclear medicine technologist </li></ul><ul><li>Medic...
How to open the safe? Careful analysis of the need and state the reasons for the purchase of the gamma camera <ul><li>Esta...
How many cameras? As an example ,  let us assume that in a certain region of a country having a stable population of 15000...
Basic calculation *) depends on the type of camera
Result Number of cameras If we assume that the number of hours per week a gammacamera can be effectively used for patient ...
End of step 1 No! Yes!
Let the vendor define Your needs and  make the selection Step 2 Write a tender  document and distribute it to the vendors
Choice of equipment <ul><li>Type of procedure to be undertaken </li></ul><ul><li>Technical specifications </li></ul><ul><l...
Siting of equipment <ul><li>Sufficient space </li></ul><ul><li>Electrical power </li></ul><ul><li>Environmental factors (t...
MAINTENANCE <ul><li>Regular maintenance will result in: </li></ul><ul><li>Increased availability of equipment </li></ul><u...
Maintenance procedures <ul><li>should include consideration of the following: </li></ul><ul><li>Overall management of the ...
EQUIPMENT <ul><li>Well trained staff with access to manuals </li></ul><ul><li>and other documentation. </li></ul><ul><li>Q...
Purpose of tendering The purpose of tendering for gamma cameras is to assess the best match between the requirements of th...
What do we want? Hardware One, two or three detector heads? Round, square or rectangular detector? Crystal thickness? Coll...
What do we want? Computer & software Acquisition modes? Application programmes? Network? Storage capacity? Backup?
What do we want? More... Education and training Payment Warranty Reliability Service and maintenance List of users Manuals...
The tender document should therefore include: <ul><li>System overview </li></ul><ul><li>Contact persons </li></ul><ul><li>...
What shall the vendor specify? <ul><li>Commercial specifications: </li></ul><ul><ul><li>Price </li></ul></ul><ul><ul><li>P...
What shall the vendor specify? <ul><li>Hardware: </li></ul><ul><ul><ul><li>Crystal size and shape </li></ul></ul></ul><ul>...
What shall the vendor specify? <ul><li>Technical performance: </li></ul><ul><ul><li>Linearity </li></ul></ul><ul><ul><li>U...
<ul><li>Computer system: </li></ul><ul><ul><li>Acquisition modes </li></ul></ul><ul><ul><li>Basic application programmes <...
What shall the vendor specify? <ul><li>… ..and more: </li></ul><ul><ul><li>User lists and site visits </li></ul></ul><ul><...
End of step 2 Distribute the tender documents to the vendors RELAX!
Step 3 The decision: Which camera fulfills our requirements?
The decision <ul><li>Can the camera and the computer software be used </li></ul><ul><li>efficiently for all types of inten...
Site visits
The decision- End of step 3 Manufacturer 1 + price + technical parameters - service - computer system Manufacturer 2 + pri...
Step 4 <ul><li>Make a clear and detailed specification of the implemen- tation agreement. </li></ul><ul><li>Which are the ...
QUALITY CONTROL EQUIPMENT Acceptance / reference testing. Measurements to assess whether instrumentation comply with its s...
Acceptance tests X-ray installations   171 Passed     10 Passed after minor corrections   123 Not passed   38 (SSI 1992)
QC GAMMA CAMERA   Acceptance  Daily  Weekly  Yearly Uniformity P T T P Uniformity, tomography P P Spectrum display P T T P...
Module 9.6. Education and training Part 9. Quality Assurance IAEA  Training  Material  on  Radiation Protection  in Nuclea...
How to achieve a high standard of safety in a hospital? <ul><li>Safety culture </li></ul><ul><li>Support from the hospital...
Education and Training   are essential for a  radiation protection programme <ul><li>As part of a the implementation of a ...
Responsibility of the licensee <ul><li>BSS 2.30.: “Provision shall be made for reducing as far as practicable the contribu...
Education <ul><li>All staff in nuclear medicine must have appropriate education to perform their duties… </li></ul><ul><li...
Education and training <ul><li>Personnel shall be instructed in radiation protection before assuming duties: </li></ul><ul...
A note of qualifications of others <ul><li>There should also be a process in place which ensures that outside contractors ...
EDUCATION AND TRAINING In addition to the staff working within the nuclear medicine department, the following staff should...
EDUCATION AND TRAINING * Basic and continuing training for those who have responsibilities for the operation of the equipm...
Continuing Education <ul><li>It is essential for all staff to have regular updates on radiation protection aspects  </li><...
Education and Training <ul><li>If the number of professionals is too small to justify setting up a training course, then i...
EDUCATION AND TRAINING Continuing education in annual refresher training courses, and whenever there is a significant chan...
Radiation protection training programme <ul><li>Basic radiation physics. </li></ul><ul><li>Biological effects of radiation...
Training Record The records should include the following information: (a)   Name of the person(s) who delivered the  instr...
Education & Training <ul><li>The Regulatory Authority should establish training curricula for (for example) : </li></ul><u...
The role of Regulatory Authority <ul><li>Require key personnel (named in RPP) to be duly accredited/qualified and to have ...
Continuous Quality Improvement <ul><li>CQI - many other acronyms are available for this </li></ul><ul><li>Part of virtuall...
And finally: QA is not a threat, it is an opportunity <ul><li>It is essential in a QA program that all staff feel free to ...
What is this? Communication!
Questions?
DISCUSSION How should the quality of a nuclear medicine practice be measured?
DISCUSSION Discuss the responsibilities in QA for the different members of the nuclear medicine staff .
DISCUSSION <ul><li>Which one of the following practices has the highest quality of the practice: </li></ul><ul><li>The mos...
Where to Get More Information <ul><li>Further readings </li></ul><ul><ul><li>IAEA TECDOC 602 </li></ul></ul><ul><ul><li>Ba...
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Radiation protection in nuclear medicine

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

    1. 1. Quality Assurance IAEA Training Material Radiation Protection in Nuclear Medicine
    2. 2. OBJECTIVE To become familiar with the concepts of Quality Assurance in radiation protection in nuclear medicine and procedures for reviewing and assessing the overall effectiveness of radiation protection
    3. 3. Content <ul><li>General principles </li></ul><ul><li>Organization of QA </li></ul><ul><li>Administrative routines </li></ul><ul><li>Occupational and Medical exposure </li></ul><ul><li>Instrumentation </li></ul><ul><li>Education and training </li></ul>
    4. 4. Part 9. Quality Assurance Module 9.1. General principles IAEA Training Material on Radiation Protection in Nuclear Medicine
    5. 5. BSS 2.29. Quality assurance programmes shall be established that provide, as appropriate: a) adequate assurance that the specified requirements relating to protection and safety are satisfied; and ` b) quality control mechanisms and procedures for reviewing and assessing the overall effectiveness of protection and safety.
    6. 6. Meaning for medical exposure that: II.22. Registrants and licensees shall establish a comprehensive quality assurance programme for medical exposures with the participation of appropriate qualified experts in the relevant fields, such as radiophysics or radiopharmacy, taking into account the principles established by the WHO and the PAHO.
    7. 7. QA-PROGRAMME OBJECTIVES <ul><li>Improvement in the quality of the </li></ul><ul><li>diagnostic information. </li></ul><ul><li>* Use of minimum amount of radionuclide </li></ul><ul><li>activity to ensure the production of the </li></ul><ul><li>desired diagnostic information. </li></ul><ul><li>* Effective use of available resources </li></ul>
    8. 8. BSS II.23. Quality assurance programmes for medical exposures shall include: a) measurements of the physical parameters of the radiation generators, imaging devices and irradiation installations at the time of commissioning and periodically thereafter, b) verification of the appropriate physical and clinical factors used in patient diagnosis or treatment; c) written records of relevant procedures and results d) verification of the appropriate calibration and conditions of operation of dosimetry and monitoring equipment; and e) as far as possible, regular and independent quality audit review of the quality assurance programme for radiotherapy procedures.
    9. 9. QUALITY ASSURANCE (definition) ” all those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality” (ISO)
    10. 10. QA and QC <ul><li>Quality Assurance is the overall process which is supported by Quality Control activities </li></ul><ul><li>Quality Control describes the actual mechanisms and procedures by which one can assure quality </li></ul>
    11. 11. QUALITY Quality of a practice is to fulfil the expectations and demands from: Patient Clinician Yourself
    12. 12. QUALITY ASSURANCE Protection Safety OVERALL QUALITY Diagnostics Therapy
    13. 13. QUALITY DEFINE OBJECTIVES How many times should the nurse be allowed to drop the child? What is an acceptable sens- itivity and specificity?
    14. 14. NUCLEAR MEDICINE SERVICE Primary service Secondary service Nuclear medicine examination or treatment facilities patient care waiting time staff reporting competence experience optimisation radiopharmaceuticals methods examination technique instrumentation etc etc
    15. 15. QUALITY ASSESSMENT Communication with the client (patient, clinician). Expectations Acceptable level Reality
    16. 16. Clinical problem <ul><ul><ul><li>Radiopharmaceutical Instrumentation </li></ul></ul></ul>Diagnosis and therapy with unsealed sources NUCLEAR MEDICINE
    17. 17. QUALITY ASSURANCE PROGRAMME A quality assurance programme in nuclear medicine should ideally include: Procedure (i.e patient history and signs, diagnostic question, appropriateness of investigation, contraindications) Planning of procedure (i.e reliable administrative procedures, patient information, patient preparation) Clinical procedure (i.e approved suppliers and materials, storage, preparation, clinical environment, patient handling and preparation, equipment performance, acquisition protocols, waste disposal) Training and experience of nuclear medicine specialists, physicists and technologists and others involved Data analysis (i.e processing protocol, equipment performance, data accuracy and integrity) Report (i.e. data, image review, results and further advice) General outcomes (i.e clinical outcome, radiation dose, patient satisfaction, referring physician satisfaction) Audit
    18. 18. Module 9.2. Organization Part 9. Quality Assurance IAEA Training Material on Radiation Protection in Nuclear Medicine
    19. 19. ORGANIZATIONS International bodies Recommendations. Interlaboratory comparison programmes. Education and training. National organizations National guidelines, codes of practice etc. Interlaboratory comparison programmes. Education and training. Industry Assistance in acceptance tests. Documentation. Training. Maintenance. Professional associations Supporting QA-programmes Establishing working groups Education and training
    20. 20. LOCAL ORGANIZATION Hospital manager (licensee) QA committee QA-group nuclear medicine (chief technician, physicist, physician, pharmacist)
    21. 21. QA Committee Membership <ul><li>Must represent the many disciplines within the department </li></ul><ul><li>Should be chaired by the Head of Department </li></ul><ul><li>As a minimum must include a medical doctor, a physicist, a technologist and an engineer responsible for service and maintenance </li></ul><ul><li>Must be appointed and supported by senior management </li></ul><ul><li>Must have sufficient depth of experience to understand the implications of the process </li></ul><ul><li>Must have the authority and access to the resources to instigate and carry out the QA process </li></ul>
    22. 22. Quality Assurance Committee <ul><li>Should ‘represent’ the department </li></ul><ul><li>Should be ‘visible’ AND accessible to staff </li></ul><ul><li>Oversees the entire Quality Assurance program </li></ul><ul><li>Writes policies to ensure the quality of patient care </li></ul><ul><li>Assists staff in tailoring the program to meet the needs of the Department (using published reports as a guide) </li></ul><ul><li>Monitor and audit the program to ensure that each component is being performed and documented </li></ul>
    23. 23. Module 9.3. Administrative routines Part 9. Quality Assurance IAEA Training Material on Radiation Protection in Nuclear Medicine
    24. 24. ADMINISTRATIVE ROUTINES Request Patient id and care Computer evaluation Diagnostic report Examination Method
    25. 25. REQUEST It is the responsibility of the nuclear medicine specialist that the study requested by the referring physician is justified . Special attention must be paid to studies requested for children and pregnant women. Are there alternative methods e.g. ultrasound, MRI etc.? Communication, on a regular basis, between the referring clinician and the nuclear medicine specialist is very important.
    26. 26. PATIENT <ul><li>Identification of the patient </li></ul><ul><li>Information about the examination </li></ul><ul><li>including premedications </li></ul><ul><li>Waiting for the examination </li></ul>A fully informed and motivated patient is the basis for a successful examination as well as a staff well educated in care of the patient.
    27. 27. YOUNG PATIENTS ..should also be informed and motivated
    28. 28. PATIENT MOVEMENT
    29. 29. PATIENT MOVEMENT moving moving moving
    30. 30. Policies and Procedures Manual <ul><li>Reviewed (typically) yearly </li></ul><ul><li>This manual contains clear and concise statements of all the policies and procedures carried out in the department </li></ul><ul><li>Updated as procedures change </li></ul>Policies and Procedures Manual
    31. 31. Policies and Procedures Manual <ul><li>As a minimum, sections should exist for </li></ul><ul><ul><li>Administrative procedures </li></ul></ul><ul><ul><li>Clinical procedures </li></ul></ul><ul><ul><li>Radiation safety </li></ul></ul>
    32. 32. Policies and Procedures Manual <ul><li>It must be “signed off” by the Head of Department and appropriate section heads </li></ul><ul><li>It is important that all staff have “ownership” to the manual - it should reflect the opinions of all and be agreed to by all </li></ul><ul><li>A list of all copies of the Manual and their location must be kept to ensure that each copy is updated </li></ul>
    33. 33. METHODS Methods should be in accordance with accepted practices Study name: Bone scan Preparation of patient: Empty bladder Radiopharmaceutical: Tc99m-MDP Route of administration: IV injection Activity: 400 MBq Type of examination: Whole body scan Views: AP, PA Scanning speed: 10 cm/minute Collimator: Scanning Window setting: 140+/-20% keV Positioning of patient: Supine Presentation of result: Images in BW on film. Original and filtered.
    34. 34. METHODS Static? Tomographic? Dynamic?
    35. 35. METHODS Tl-201 Tc-99m 25 mSv 8 mSv
    36. 36. QUALITY ASSURANCE COMPUTER EVALUATION <ul><li>Efficient use of computers can </li></ul><ul><li>increase the sensitivity and </li></ul><ul><li>specificity of an examination. </li></ul><ul><li>software based on published and clinically tested methods </li></ul><ul><li>well documented algorithms </li></ul><ul><li>user manuals </li></ul><ul><li>training </li></ul><ul><li>software phantoms </li></ul>
    37. 37. <ul><li>Analysis of the programme code </li></ul><ul><li>Phantom studies </li></ul><ul><li>Simulated examinations </li></ul><ul><li>Reference data (normal material) </li></ul><ul><li>Clinical evaluation </li></ul>Q C Application programmes
    38. 38. Bone scan phantom
    39. 39. Thyroid phantom
    40. 41. DIAGNOSTIC REPORT Patient identification Date and type of study Radiopharmaceutical and activity Study results - e.g. a graph or a series of images Objective description of findings Diagnostic conclusion and recommendations Avoid adjectives like ’possible’, ’probable’, ’likely’ etc. They can never be interpretated by the referring physician. The diagnostic conclusion should be more quantitative e.g. by using a probability statement.
    41. 42. QUALITY ASSURANCE METHOD Patient follow-up. Correlation with other available surgical, pathological, clinical and anatomic information. False positives? False negatives?
    42. 43. Society of Nuclear Medicine Procedure Guideline for General Imaging The final judge of any analytical method is a clinical audit: the correctness and impact of the decisions made with respect to any method and process.
    43. 44. RECORDS <ul><li>Authorization certificate and documentation supporting the corresponding application, and also any correspondence between the licensee and Regulatory Authority; </li></ul><ul><li>Name of the person authorized and responsible for the RPP; </li></ul><ul><li>Individual doses (current and prior work history); </li></ul><ul><li>Results of area surveys; </li></ul><ul><li>Equipment and instrument QC tests and calibration; </li></ul><ul><li>Inventory of unsealed and sealed sources; </li></ul><ul><li>Incident and accident investigation reports; </li></ul><ul><li>Audits and reviews of the radiation safety programme; </li></ul><ul><li>Installation, maintenance and repair work; </li></ul><ul><li>Facility modification; </li></ul>
    44. 45. RECORDS (cont) <ul><li>Training provided (initial and continuing), including the following information: </li></ul><ul><li>Name of the person(s) who delivered the instruction or training; </li></ul><ul><li>Name of the person(s) who received the instruction or training; </li></ul><ul><li>Date and duration of the instruction or training; </li></ul><ul><li>List of the topics addressed; and </li></ul><ul><li>Copy of the certificates of training. </li></ul><ul><li>Evidence of health surveillance of workers; </li></ul><ul><li>Waste disposal ; </li></ul><ul><li>Transportation: </li></ul><ul><li>Package documentation; </li></ul><ul><li>Package surveys; </li></ul><ul><li>Transfer/receipt documents; and </li></ul><ul><li>Details of shipments dispatched </li></ul><ul><li>Patient records; and </li></ul><ul><li>Patient discharge surveys for patients receiving radionuclide therapy. </li></ul>
    45. 46. Module 9.4. Occupational and medical exposure Part 9. Quality Assurance IAEA Training Material on Radiation Protection in Nuclear Medicine
    46. 47. EXAMINATION Request Patient id and care Computer Evaluation Diagnostic report Examination Method
    47. 48. Patient The patient shall always be confident that a nuclear medicine examination and therapy is performed correctly and with highest possible quality regarding both diagnostics/therapy and safety.
    48. 49. Medical exposure <ul><li>Choice of examination </li></ul><ul><li>Determination of technical parameters </li></ul><ul><li>Optimization of administered activity </li></ul><ul><li>Methods of reducing the absorbed dose </li></ul><ul><li>Quality control of equipment and radiopharmaceutical </li></ul><ul><li>Quality assurance of methods </li></ul><ul><li>Safe routines to avoid misadministration </li></ul>
    49. 50. Factors affecting medical and occupational exposure Receipt and storage Preparation Contamination Radioactive waste Detection (QC equipment) Administration
    50. 51. QUALITY CONTROL RADIOPHARMACEUTICALS <ul><li>Radionuclide purity (other radionuclides?) </li></ul><ul><li>Radiochemical purity (labelling efficiency) </li></ul><ul><li>Chemical purity (toxic substances?) </li></ul><ul><li>Sterility </li></ul><ul><li>Absence of pyrogens </li></ul>Responsibility of the approved manufacturer and supplier
    51. 52. QUALITY ASSURANCE RADIOPHARMACEUTICALS <ul><li>Quality control of radiopharmaceuticals. </li></ul><ul><li>Written and trained procedures in preparation and </li></ul><ul><li>safe handling of radiopharmaceuticals </li></ul><ul><li>Use of a unique code which guarantee the ability </li></ul><ul><li>to trace the origin of all components in the preparation. </li></ul><ul><li>Records of radionuclides, kits etc. </li></ul><ul><li>Labeling of vials and syringes. </li></ul><ul><li>Measurement of activity. </li></ul>
    52. 53. PREPARATION OF RADIOPHARMACEUTICALS Tc99m-MDP 2237 5 447 SC 1997-09-28 7.40 <ul><li>Use a transparent vial shield </li></ul><ul><li>Put the kit in the shield </li></ul><ul><li>Add Tc99m and finish the </li></ul><ul><li>preparation </li></ul><ul><li>Measure the activity </li></ul><ul><li>Write the label and put it on </li></ul><ul><li>the vial shield </li></ul><ul><li>Check the kit and the label on </li></ul><ul><li>the vial shield. Same radiopharma- </li></ul><ul><li>ceutical? </li></ul>
    53. 54. DISPENSING RADIOPHARMACEUTICALS Tc99m-MDP 400 MBq 400928-3336 1997-09-28 07.45 SC <ul><li>Check kit and vial shield label </li></ul><ul><li>Correct radiopharmaceutical? </li></ul><ul><li>Draw the required volume </li></ul><ul><li>Measure the activity </li></ul><ul><li>Write the label and put it on </li></ul><ul><li>the syringe shield </li></ul>
    54. 55. INJECTING RADIOPHARMACEUTICALS <ul><li>Patient name? </li></ul><ul><li>Patient identification number? </li></ul><ul><li>Pregnant? </li></ul><ul><li>Breastfeeding? </li></ul><ul><li>Check the request form </li></ul><ul><li>Check the label of the syringe. </li></ul><ul><li>Correct radiopharmaceutical </li></ul><ul><li>for the required examination? </li></ul><ul><li>Correct activity? </li></ul><ul><li>Inject! </li></ul>
    55. 56. Worker The worker should always feel confident that he/she has the necessary training in order to perform his/her duty. The worker should feel that he/she gets the necessary support from the licensee in matters concerning working situation and safety.
    56. 57. FACTORS AFFECTING QUALITY <ul><li>Design of facility </li></ul><ul><li>Safe receipt and storage of unsealed sources </li></ul><ul><li>Safe handling of unsealed sources </li></ul><ul><li>Management of radioactive waste </li></ul><ul><li>Safety equipment </li></ul><ul><li>Personal monitoring </li></ul><ul><li>Health surveillance </li></ul><ul><li>Workplace monitoring </li></ul><ul><li>Emergency procedures </li></ul><ul><li>Local rules </li></ul><ul><li>Training and experience of staff </li></ul>
    57. 58. EDUCATION OF STAFF Correct use of equipment Close 15 cm Wrong setting of energy window
    58. 59. Module 9.5. Instrumentation Part 9. Quality Assurance IAEA Training Material on Radiation Protection in Nuclear Medicine
    59. 60. How to get a new Gamma camera? Step 1
    60. 61. PURCHASE GROUP <ul><li>Nuclear medicine specialist </li></ul><ul><li>Nuclear medicine technologist </li></ul><ul><li>Medical physicist </li></ul><ul><li>Medical engineer </li></ul><ul><li>Person from the hospital administration </li></ul>
    61. 62. How to open the safe? Careful analysis of the need and state the reasons for the purchase of the gamma camera <ul><li>Establishment of a nuclear medicine service </li></ul><ul><li>Increased volume of patients </li></ul><ul><li>The technical performance is not good enough </li></ul><ul><li>for new methods </li></ul><ul><li>No spare parts available </li></ul><ul><li>Unrepairable </li></ul>
    62. 63. How many cameras? As an example , let us assume that in a certain region of a country having a stable population of 150000 there are plans to establish a nuclear medicine facility. The mean number of examinations in the country is 15 per 1000 population and year but the new department should be designed to fulfil a future need of 20 per 1000 population, which means that the total number of examinations will be 3000 per year or 60 per week
    63. 64. Basic calculation *) depends on the type of camera
    64. 65. Result Number of cameras If we assume that the number of hours per week a gammacamera can be effectively used for patient examinations to be 28 (70% of 40) then the number of cameras should be 66/28=2.4. This figure should be further corrected by taking into account the time needed for regular maintenance of the equipment as well as unplanned stops due to different failures.
    65. 66. End of step 1 No! Yes!
    66. 67. Let the vendor define Your needs and make the selection Step 2 Write a tender document and distribute it to the vendors
    67. 68. Choice of equipment <ul><li>Type of procedure to be undertaken </li></ul><ul><li>Technical specifications </li></ul><ul><li>Manufacturer </li></ul><ul><li>Spare parts </li></ul><ul><li>Service and maintenance </li></ul><ul><li>User and service manuals </li></ul><ul><li>Education and training </li></ul><ul><li>Local user </li></ul><ul><li>Service and maintenance </li></ul><ul><li>Education and experience of staff </li></ul><ul><li>Siting of the instrument </li></ul><ul><li>Ease, reliability and safety in operation </li></ul><ul><li>Cost </li></ul>
    68. 69. Siting of equipment <ul><li>Sufficient space </li></ul><ul><li>Electrical power </li></ul><ul><li>Environmental factors (temperature, </li></ul><ul><li>humidity, air pollution) </li></ul><ul><li>Structural shielding </li></ul><ul><li>Background radiation </li></ul>
    69. 70. MAINTENANCE <ul><li>Regular maintenance will result in: </li></ul><ul><li>Increased availability of equipment </li></ul><ul><li>Increased quality by better performance </li></ul><ul><li>Increased safety </li></ul><ul><li>Increased lifetime of equipment </li></ul>
    70. 71. Maintenance procedures <ul><li>should include consideration of the following: </li></ul><ul><li>Overall management of the maintenance programme. This is often </li></ul><ul><li>provided by the medical physicist in co-operation with the RPO; </li></ul><ul><li>Measures to prevent the use of equipment during periods of </li></ul><ul><li>maintenance; </li></ul><ul><li>Notification of the medical physicist whenever there is a repair, </li></ul><ul><li>regardless of its importance. The physicist must assess whether any </li></ul><ul><li>tests or measurements are to be made and whether the equipment is </li></ul><ul><li>operating satisfactorily before it is used with patients; </li></ul><ul><li>Provision of a service contract covering preventative maintenance, </li></ul><ul><li>particularly when equipment parts and expertise are provided by the </li></ul><ul><li>manufacturer; </li></ul><ul><li>Maintenance of a service record during the lifetime of the equipment </li></ul><ul><li>or for a duration specified by the Regulatory Authority. </li></ul>
    71. 72. EQUIPMENT <ul><li>Well trained staff with access to manuals </li></ul><ul><li>and other documentation. </li></ul><ul><li>Quality control program. </li></ul><ul><li>Regular maintenance. </li></ul>NEEDS FOR EFFICIENT USE
    72. 73. Purpose of tendering The purpose of tendering for gamma cameras is to assess the best match between the requirements of the clinical department and the equipment available and not necessarily to buy the 'best camera’.
    73. 74. What do we want? Hardware One, two or three detector heads? Round, square or rectangular detector? Crystal thickness? Collimators? Whole body scanning? PET-option? Transmission source?
    74. 75. What do we want? Computer & software Acquisition modes? Application programmes? Network? Storage capacity? Backup?
    75. 76. What do we want? More... Education and training Payment Warranty Reliability Service and maintenance List of users Manuals and other documentation Time of delivery Upgradability Quality control equipment Acceptance test
    76. 77. The tender document should therefore include: <ul><li>System overview </li></ul><ul><li>Contact persons </li></ul><ul><li>Commercial specifications </li></ul><ul><li>Technical specifications </li></ul><ul><li>Data acquisition and processing </li></ul><ul><li>Electrical and mechanical safety (national regulations) </li></ul><ul><li>Education and training </li></ul><ul><li>Documentation </li></ul><ul><li>Service organization </li></ul><ul><li>Installation and acceptance testing </li></ul>
    77. 78. What shall the vendor specify? <ul><li>Commercial specifications: </li></ul><ul><ul><li>Price </li></ul></ul><ul><ul><li>Payment </li></ul></ul><ul><ul><li>Warranty </li></ul></ul><ul><ul><li>Liability insurance for installers </li></ul></ul><ul><ul><li>Right to refuse or remove equipment </li></ul></ul><ul><ul><li>Value of the old camera </li></ul></ul>
    78. 79. What shall the vendor specify? <ul><li>Hardware: </li></ul><ul><ul><ul><li>Crystal size and shape </li></ul></ul></ul><ul><ul><ul><li>PM-tubes </li></ul></ul></ul><ul><ul><ul><li>Gantry dimension and weight </li></ul></ul></ul><ul><ul><ul><li>Gantry movements, including auto- contour </li></ul></ul></ul><ul><ul><ul><li>Electrical power requirements </li></ul></ul></ul><ul><ul><ul><li>Imaging table </li></ul></ul></ul><ul><ul><ul><li>Collimators and method of change </li></ul></ul></ul><ul><ul><ul><li>Shielding of detector </li></ul></ul></ul><ul><ul><ul><li>Operating console </li></ul></ul></ul><ul><ul><ul><li>Energy windows </li></ul></ul></ul><ul><ul><ul><li>Energy range </li></ul></ul></ul><ul><ul><ul><li>Safety features </li></ul></ul></ul><ul><ul><ul><li>Motion control </li></ul></ul></ul>
    79. 80. What shall the vendor specify? <ul><li>Technical performance: </li></ul><ul><ul><li>Linearity </li></ul></ul><ul><ul><li>Uniformity (different energies, different angles) </li></ul></ul><ul><ul><li>Energy resolution </li></ul></ul><ul><ul><li>Spatial resolution (intrinsic and system, planar and tomographic) </li></ul></ul><ul><ul><li>Count rate performance </li></ul></ul><ul><ul><li>Center of rotation </li></ul></ul><ul><ul><li>Multiple window spatial positioning </li></ul></ul><ul><ul><li>System sensitivity (planar and tomographic) </li></ul></ul><ul><ul><li>Point source sensitivity </li></ul></ul>
    80. 81. <ul><li>Computer system: </li></ul><ul><ul><li>Acquisition modes </li></ul></ul><ul><ul><li>Basic application programmes </li></ul></ul><ul><ul><li>Clinical application programmes </li></ul></ul><ul><ul><li>Quality control programmes </li></ul></ul><ul><ul><li>DICOM-standard </li></ul></ul><ul><ul><li>Network and communication </li></ul></ul><ul><ul><li>Printers </li></ul></ul><ul><ul><li>Storage and backup of patient data </li></ul></ul>What shall the vendor specify?
    81. 82. What shall the vendor specify? <ul><li>… ..and more: </li></ul><ul><ul><li>User lists and site visits </li></ul></ul><ul><ul><li>Reliability (e.g. 95%) </li></ul></ul><ul><ul><li>Service response time and follow up </li></ul></ul><ul><ul><li>Training now and later </li></ul></ul><ul><ul><li>Service manuals </li></ul></ul><ul><ul><li>Upgradability </li></ul></ul><ul><ul><li>Delivery, setup and installation date </li></ul></ul><ul><ul><li>Floor loading, elevators and doors </li></ul></ul><ul><ul><li>Electrical requirements </li></ul></ul>
    82. 83. End of step 2 Distribute the tender documents to the vendors RELAX!
    83. 84. Step 3 The decision: Which camera fulfills our requirements?
    84. 85. The decision <ul><li>Can the camera and the computer software be used </li></ul><ul><li>efficiently for all types of intended examinations? </li></ul><ul><li>Are the technical specifications satisfactory? </li></ul><ul><li>Is the camera easy to handle? </li></ul><ul><li>Is the price reasonable? </li></ul><ul><li>Is the manufacturers service organization satisfactory? </li></ul><ul><li>Is the required training OK? </li></ul>
    85. 86. Site visits
    86. 87. The decision- End of step 3 Manufacturer 1 + price + technical parameters - service - computer system Manufacturer 2 + price - technical parameters + service - computer system We want that one!!
    87. 88. Step 4 <ul><li>Make a clear and detailed specification of the implemen- tation agreement. </li></ul><ul><li>Which are the users responsibilities? </li></ul><ul><li>Which are the vendors responsibilities? </li></ul><ul><li>Which documents are valid? </li></ul><ul><li>Date of delivery? </li></ul><ul><li>Mode of payment? </li></ul><ul><li>Warranty? </li></ul>Sign the contract Make the installation Perform an acceptance test
    88. 89. QUALITY CONTROL EQUIPMENT Acceptance / reference testing. Measurements to assess whether instrumentation comply with its specifications. Manual available. Routine testing. Performed to maintain high quality and standard of the equipment. Analysis of results. Is the observed result significantly different from the reference testing? Is the observed result due to errors in the QC procedure? Records.
    89. 90. Acceptance tests X-ray installations 171 Passed 10 Passed after minor corrections 123 Not passed 38 (SSI 1992)
    90. 91. QC GAMMA CAMERA Acceptance Daily Weekly Yearly Uniformity P T T P Uniformity, tomography P P Spectrum display P T T P Energy resolution P P Sensitivity P T P Pixel size P T P Center of rotation P T P Linearity P P Resolution P P Count losses P P Multiple window pos P P Total performance phantom P P P: physicist, T: technician
    91. 92. Module 9.6. Education and training Part 9. Quality Assurance IAEA Training Material on Radiation Protection in Nuclear Medicine
    92. 93. How to achieve a high standard of safety in a hospital? <ul><li>Safety culture </li></ul><ul><li>Support from the hospital management </li></ul><ul><li>Well educated staff </li></ul><ul><li>Local radiation protection organization </li></ul><ul><li>Quality assurance programme </li></ul><ul><li>Use of authorized services </li></ul><ul><li>Continuing education and training </li></ul><ul><li>Arrangements for individual </li></ul><ul><li>monitoring and health surveillance </li></ul><ul><li>Records </li></ul><ul><li>Documented local rules and procedures </li></ul>
    93. 94. Education and Training are essential for a radiation protection programme <ul><li>As part of a the implementation of a Radiation Protection Programme (IAEA TECDOC 1040, 2.2.1): “Early in the process a decision should be made about additional training required for the hospital staff…” </li></ul><ul><li>The relevant plan should include who, where and when shall be trained. </li></ul>
    94. 95. Responsibility of the licensee <ul><li>BSS 2.30.: “Provision shall be made for reducing as far as practicable the contribution of human error to accidents and other events that could give rise to exposures, by ensuring that: </li></ul><ul><ul><li>(a) all personnel on whom protection and safety depend be appropriately trained and qualified so that they understand their responsibilities and perform their duties with appropriate judgement and according to defined procedures;” </li></ul></ul>
    95. 96. Education <ul><li>All staff in nuclear medicine must have appropriate education to perform their duties… </li></ul><ul><li>For radiation protection purposes this affects particularly: </li></ul><ul><ul><li>Radiation Protection Officer </li></ul></ul><ul><ul><li>Physician </li></ul></ul><ul><ul><li>Qualified Expert (Medical Physicist) </li></ul></ul><ul><ul><li>Nuclear Medicine Technician </li></ul></ul><ul><ul><li>… . </li></ul></ul>
    96. 97. Education and training <ul><li>Personnel shall be instructed in radiation protection before assuming duties: </li></ul><ul><li>the conditions of the licence; </li></ul><ul><li>safe use and operation of equipment; </li></ul><ul><li>instructions that should be provided to patients and patient helpers; </li></ul><ul><li>institutional radiation protection policies and procedures (including emergency practice drills); </li></ul><ul><li>the local QA programme and QC procedures; </li></ul><ul><li>the results of review and analysis of incidents and accidents that have occurred in the institution or elsewhere. </li></ul>
    97. 98. A note of qualifications of others <ul><li>There should also be a process in place which ensures that outside contractors on whom radiation protection may depend (e.g. service engineers) are appropriately trained and qualified. </li></ul>
    98. 99. EDUCATION AND TRAINING In addition to the staff working within the nuclear medicine department, the following staff should receive instruction from the RPO: nurses in wards with radioactive patients; staff who do not belong to the nuclear medicine practice but need to enter controlled areas; and staff who transport radioactive patients or radioactive materials within the institution.
    99. 100. EDUCATION AND TRAINING * Basic and continuing training for those who have responsibilities for the operation of the equipment or for preparations of radio- pharmaceuticals. * Advanced training for physicians, physicists and radiochemists. * Continuing education for those who have operational responsibilities in a nuclear medicine facility.
    100. 101. Continuing Education <ul><li>It is essential for all staff to have regular updates on radiation protection aspects </li></ul><ul><li>Continuing education must be documented </li></ul>
    101. 102. Education and Training <ul><li>If the number of professionals is too small to justify setting up a training course, then international co-operation programs may be used </li></ul><ul><li>Distance learning programs may be useful </li></ul><ul><li>A course such as the present may play an important role... </li></ul>
    102. 103. EDUCATION AND TRAINING Continuing education in annual refresher training courses, and whenever there is a significant change in duties, regulations, terms of the license, or type of radioactive material or instruments used . Topics should be selected from a syllabus which has been approved by the RPC. Today we will talk about Patient safety
    103. 104. Radiation protection training programme <ul><li>Basic radiation physics. </li></ul><ul><li>Biological effects of radiation. </li></ul><ul><li>International standards in Radiation Protection </li></ul><ul><li>Responsibility and duties. </li></ul><ul><li>Safe handling of radioactive materials. </li></ul><ul><li>Occupational radiation protection. </li></ul><ul><li>Medical exposure. </li></ul><ul><li>Management of radioactive waste. </li></ul><ul><li>Protection of the public. </li></ul><ul><li>Emergency preparedness. </li></ul><ul><li>Organization of radiation protection </li></ul>
    104. 105. Training Record The records should include the following information: (a)   Name of the person(s) who delivered the instruction or training; (b)   Name of the person(s) who received the instruction or training; (c)   Date and duration of the instruction or training; (d)   List of the topics addressed; (e)   Copy of the certificates of training
    105. 106. Education & Training <ul><li>The Regulatory Authority should establish training curricula for (for example) : </li></ul><ul><ul><li>RPOs </li></ul></ul><ul><ul><li>members of the RPC </li></ul></ul><ul><ul><li>relevant physicians </li></ul></ul><ul><ul><li>medical physicists </li></ul></ul><ul><ul><li>laboratory staff </li></ul></ul>
    106. 107. The role of Regulatory Authority <ul><li>Require key personnel (named in RPP) to be duly accredited/qualified and to have adequate training in radiation protection. </li></ul><ul><li>Specify/approve minimum training standards/syllabus content for radiation protection training courses. </li></ul><ul><li>Provide training courses, perhaps in conjunction with other contributors, if courses are otherwise unavailable in the country. </li></ul>
    107. 108. Continuous Quality Improvement <ul><li>CQI - many other acronyms are available for this </li></ul><ul><li>Part of virtually all QA systems </li></ul><ul><li>Improved methods are documented in clinical trial reports. </li></ul><ul><li>Quality assurance protocols are continuously under development in many countries </li></ul><ul><li>Regular Quality Assurance meeting for all members of a Section </li></ul><ul><li>Continuing education - lectures, workshops, journal clubs and must be available for all staff </li></ul>
    108. 109. And finally: QA is not a threat, it is an opportunity <ul><li>It is essential in a QA program that all staff feel free to report errors </li></ul><ul><li>A non threatening environment must exist </li></ul><ul><li>Reward honesty with encouragement </li></ul><ul><li>Education is the key, not punishment </li></ul>
    109. 110. What is this? Communication!
    110. 111. Questions?
    111. 112. DISCUSSION How should the quality of a nuclear medicine practice be measured?
    112. 113. DISCUSSION Discuss the responsibilities in QA for the different members of the nuclear medicine staff .
    113. 114. DISCUSSION <ul><li>Which one of the following practices has the highest quality of the practice: </li></ul><ul><li>The most modern equipment and unqualified persons running it. </li></ul><ul><li>Old equipment and qualified people running it. </li></ul>
    114. 115. Where to Get More Information <ul><li>Further readings </li></ul><ul><ul><li>IAEA TECDOC 602 </li></ul></ul><ul><ul><li>Basic Safety Standards </li></ul></ul><ul><ul><li>WHO publications </li></ul></ul><ul><ul><li>ISO publications </li></ul></ul>
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