Radiation Protection in Nuclear Medicine

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IAEA Training Material Radiation Protection in Nuclear Medicine
Part 9
Quality Assurance
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
Nuclear Medicine
Part 9. Quality Assurance
2
Contents
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Nuclear Medicine
General principles
Organization of QA
Administrative routines
Occupational and Medical exposure
Instrumentation
Education and training
Part 9. Quality Assurance
3
IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 9.
Quality Assurance
Module 9.1. General Principles
QA Programme Objectives
• Improvement in the quality of the
diagnostic information.
* Use of minimum amount of radionuclide
activity to ensure the production of the
desired diagnostic information.
* Effective use of available resources
Nuclear Medicine
Part 9. Quality Assurance
5
Quality Assurance
BSS: Interim Edition
“3.169. Registrants and licensees, in applying the requirements
of these Standards in respect of management systems, shall
establish a comprehensive programme of quality assurance for
medical exposures with the active participation of medical
physicists, radiological medical practitioners, medical radiation
technologists and, for complex nuclear medicine facilities,
radiopharmacists and radiochemists, and in conjunction with
other health professionals as appropriate. Principles established
by the World Health Organization, the Pan American Health
Organization and relevant professional bodies shall be taken into
account.”
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Quality Assurance
BSS: Interim Edition
“3.170 Registrants and licensees shall ensure that
programmes of quality assurance for medical
exposure include, as appropriate to the medical
radiation facility”
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Part 9. Quality Assurance
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Quality Assurance
contd..
“(a) Measurements of the physical parameters of medical radiological
equipment made by, or under the supervision of, a medical physicist:
(i) At the time of acceptance and commissioning of the
equipment prior to its clinical use on patients;
(ii) Periodically thereafter;
(iii) After any major maintenance procedure that could affect
protection and safety of patients;
(iv) After any installation of new software or modification of
existing software that could affect protection and safety of patients;
(b) Implementation of corrective actions if measured values of the
physical parameters mentioned in (a) are outside established tolerance
limits;
(c) Verification of the appropriate physical and clinical factors used in
radiological procedures;
(d) Maintaining records of relevant procedures and results;
(e) Periodic checks of the calibration and conditions of operation of
dosimetry equipment and monitoring equipment.”
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Quality Assurance
(Definition)
“all those planned and systematic actions necessary
to provide adequate confidence that a product or
service will satisfy given requirements for quality”
(ISO)
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Part 9. Quality Assurance
9
QA and QC
Quality Assurance is the overall process
which is supported by Quality Control
activities
 Quality Control describes the actual
mechanisms and procedures by which
one can assure quality

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Part 9. Quality Assurance
10
Quality
Quality of a practice is to fulfil the
expectations and demands from:
Clinician
Patient
Yourself
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Quality Assurance
OVERALL QUALITY
Diagnostics
Therapy
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Protection
Safety
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12
Quality
Define Objectives
How many times should the nurse
be allowed to drop the child?
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What is an acceptable sensitivity and specificity?
Part 9. Quality Assurance
13
Nuclear Medicine Service
facilities
patient care
waiting time
staff
reporting
competence
experience
optimisation
radiopharmaceuticals
methods
examination technique
instrumentation
etc
etc
Nuclear Medicine
Primary
service
Secondary
service
Part 9. Quality Assurance
Nuclear
medicine
examination
or
treatment
14
Quality Assessment
Communication with the
client (patient, clinician).
Expectations
Acceptable level
Reality
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Part 9. Quality Assurance
15
Nuclear Medicine
Diagnosis and Therapy with
Unsealed Sources
Clinical problem
Radiopharmaceutical
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Part 9. Quality Assurance
Instrumentation
16
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
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IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 9.
Quality Assurance
Module 9.2. Organization
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
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Local Organization
Hospital manager (licensee)
QA committee
QA-group nuclear medicine
(chief technician, physicist, physician, pharmacist)
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QA Committee Membership
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Must represent the many disciplines within the department
Should be chaired by the Head of Department
As a minimum must include a medical doctor, a physicist, a
technologist and an engineer responsible for service and
maintenance
Must be appointed and supported by senior management
Must have sufficient depth of experience to understand the
implications of the process
Must have the authority and access to the resources to instigate
and carry out the QA process
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Quality Assurance Committee
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Should ‘represent’ the department
Should be ‘visible’ AND accessible to staff
Oversees the entire Quality Assurance program
Writes policies to ensure the quality of patient care
Assists staff in tailoring the program to meet the
needs of the Department (using published reports as
a guide)
Monitor and audit the program to ensure that each
component is being performed and documented
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IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 9.
Quality Assurance
Module 9.3. Administrative Routines
Administrative Routines
Nuclear Medicine
Request
Patient id
and care
Examination
Method
Computer
evaluation
Diagnostic
report
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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.
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Patient
• Identification of the patient
• Information about the examination
including premedications
• Waiting for the examination
A fully informed and motivated patient is the
basis for a successful examination as well as
a staff well educated in care of the patient.
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Young Patients
..should also be informed and motivated
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Patient Movement
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Patient Movement
moving
moving
moving
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Policies and Procedures Manual


Reviewed (typically) yearly
This manual contains clear and concise
statements of all the policies and
procedures carried out in the department
Updated as procedures change
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Policies and Procedures
Manual

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Policies and Procedures Manual

As a minimum, sections should exist for
 Administrative procedures
 Clinical procedures
 Radiation safety
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Policies and Procedures Manual
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
It must be “signed off” by the Head of
Department and appropriate section heads
It is important that all staff have “ownership” to
the manual - it should reflect the opinions of all
and be agreed to by all
A list of all copies of the Manual and their
location must be kept to ensure that each copy is
updated
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Methods
Methods should be in accordance with accepted practices
Study name:
Preparation of patient:
Radiopharmaceutical:
Route of administration:
Activity:
Type of examination:
Views:
Scanning speed:
Collimator:
Window setting:
Positioning of patient:
Presentation of result:
Nuclear Medicine
Bone scan
Empty bladder
Tc99m-MDP
IV injection
400 MBq
Whole body scan
AP, PA
10 cm/minute
Scanning
140+/-20% keV
Supine
Images in BW on film.
Original and filtered.
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Methods
Static?
Tomographic?
Dynamic?
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Methods
Tl-201
25 mSv
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Tc-99m
8 mSv
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35
Quality Assurance
Computer Evaluation
Efficient use of computers can
increase the sensitivity and
specificity of an examination.
•software based on published and
clinically tested methods
•well documented algorithms
•user manuals
•training
•software phantoms
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QC Application Programmes

Analysis of the programme code

Phantom studies

Simulated examinations

Reference data (normal material)

Clinical evaluation
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Bone Scan Phantom
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Thyroid Phantom
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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.
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Quality Assurance
Method
Patient follow-up.
Correlation with other available
surgical, pathological, clinical and
anatomic information.
False positives?
False negatives?
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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.
Society of Nuclear Medicine
Procedure Guideline for General
Imaging
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Records
•Authorization certificate and documentation supporting the
corresponding application, and also any correspondence
between the licensee and Regulatory Authority;
•Name of the person authorized and responsible for the
RPP;
•Individual doses (current and prior work history);
•Results of area surveys;
•Equipment and instrument QC tests and calibration;
•Inventory of unsealed and sealed sources;
•Incident and accident investigation reports;
•Audits and reviews of the radiation safety programme;
•Installation, maintenance and repair work;
•Facility modification;
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Records (contd..)
•Training provided (initial and continuing), including the following
information:
Name of the person(s) who delivered the instruction or
training;
Name of the person(s) who received the instruction or
training;
Date and duration of the instruction or training;
List of the topics addressed; and
Copy of the certificates of training.
•Evidence of health surveillance of workers;
•Waste disposal;
•Transportation:
Package documentation;
Package surveys;
Transfer/receipt documents; and
Details of shipments dispatched
•Patient records; and
•Patient discharge surveys for patients receiving radionuclide therapy.
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IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 9.
Quality Assurance
Module 9.4. Occupational and
Medical Exposure
Examination
Nuclear Medicine
Request
Patient id
and care
Examination
Method
Computer
Evaluation
Diagnostic
report
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The patient shall always be confident
that a nuclear medicine examination
and therapy is performed correctly and
with highest possible quality regarding
both diagnostics/therapy and safety.
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Medical Exposure
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Choice of examination
Determination of technical parameters
Optimization of administered activity
Methods of reducing the absorbed dose
Quality control of equipment and
radiopharmaceutical
Quality assurance of methods
Safe routines to avoid misadministration
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Factors Affecting Medical and
Occupational Exposure
Receipt and
storage
Preparation
Detection
(QC equipment)
Administration
Contamination
Radioactive
waste
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Quality Control
Radiopharmaceuticals
• Radionuclide purity (other radionuclides?)
• Radiochemical purity (labelling efficiency)
• Chemical purity (toxic substances?)
• Sterility
• Absence of pyrogens
Responsibility of the approved manufacturer
and supplier
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Quality Assurance
Radiopharmaceuticals
• Quality control of radiopharmaceuticals.
• Written and trained procedures in preparation and
safe handling of radiopharmaceuticals
• Use of a unique code which guarantee the ability
to trace the origin of all components in the preparation.
• Records of radionuclides, kits etc.
• Labeling of vials and syringes.
• Measurement of activity.
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Preparation of
Radiopharmaceuticals
• Use a transparent vial shield
• Put the kit in the shield
• Add Tc99m and finish the
preparation
• Measure the activity
• Write the label and put it on
the vial shield
• Check the kit and the label on
the vial shield. Same radiopharmaceutical?
Nuclear Medicine
Part 9. Quality Assurance
Tc99m-MDP
2237
447
1997-09-28
5
SC
7.40
53
Dispensing Radiopharmaceuticals
• Check kit and vial shield label
Correct radiopharmaceutical?
• Draw the required volume
• Measure the activity
• Write the label and put it on
the syringe shield
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Part 9. Quality Assurance
Tc99m-MDP 400 MBq
400928-3336
1997-09-28 07.45
SC
54
Injecting Radiopharmaceuticals
• Patient name?
• Patient identification number?
• Pregnant?
• Breastfeeding?
• Check the request form
• Check the label of the syringe.
Correct radiopharmaceutical
for the required examination?
Correct activity?
• Inject!
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The worker should always feel confident
that he/she has the necessary training
in order to perform his/her duty.
The worker should feel that he/she gets the
necessary support from the licensee in
matters concerning working situation and
safety.
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Factors Affecting Quality
•Design of facility
•Safe receipt and storage of unsealed sources
•Safe handling of unsealed sources
•Management of radioactive waste
•Safety equipment
•Personal monitoring
•Health surveillance
•Workplace monitoring
•Emergency procedures
•Local rules
•Training and experience of staff
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Education of Staff
Correct use of Equipment
Close
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15 cm
Part 9. Quality Assurance
Wrong setting
of energy window
58
IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 9.
Quality Assurance
Module 9.5. Instrumentation
How to get a new
Gamma camera?
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Purchase Group
•Nuclear medicine specialist
•Nuclear medicine technologist
•Medical physicist
•Medical engineer
•Person from the hospital administration
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How to open the safe?
Careful analysis of the need and state the reasons for
the purchase of the gamma camera
•Establishment of a nuclear medicine service
•Increased volume of patients
•The technical performance is not good enough
for new methods
•No spare parts available
•Unrepairable
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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
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Basic Calculation
Type of examination
Bone
Lungs
Liver
CBF
Myocard
Kidneys
Thyroid
Others
Quality control
Total
Examinations per
week
20
6
2
5
10
8
5
4
1
61
Time (h) per
examination *)
1
0.5
0.8
1
2
0.75
0.5
1
3
Total time (h) per
week
20
3
2
5
20
6
3
4
3
66
*) depends on the type of camera
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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.
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End of step 1
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Let the vendor
define Your needs and
make the selection
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Write a tender
document and distribute
it to the vendors
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Choice of Equipment
•Type of procedure to be undertaken
•Technical specifications
•Manufacturer
Spare parts
Service and maintenance
User and service manuals
Education and training
•Local user
Service and maintenance
Education and experience of staff
Siting of the instrument
•Ease, reliability and safety in operation
•Cost
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Setting of Equipment
•Sufficient space
•Electrical power
•Environmental factors (temperature,
humidity, air pollution)
•Structural shielding
•Background radiation
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Maintenance
Regular maintenance will result in:
•Increased availability of equipment
•Increased quality by better performance
•Increased safety
•Increased lifetime of equipment
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Maintenance Procedures
should include consideration of the following:
• Overall management of the maintenance programme. This is often
provided by the medical physicist in co-operation with the RPO;
• Measures to prevent the use of equipment during periods of
maintenance;
• Notification of the medical physicist whenever there is a repair,
regardless of its importance. The physicist must assess whether any
tests or measurements are to be made and whether the equipment is
operating satisfactorily before it is used with patients;
• Provision of a service contract covering preventative maintenance,
particularly when equipment parts and expertise are provided by the
manufacturer;
• Maintenance of a service record during the lifetime of the equipment
or for a duration specified by the Regulatory Authority.
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Equipment
NEEDS FOR EFFICIENT USE
• Well trained staff with access to manuals
and other documentation.
• Quality control program.
• Regular maintenance.
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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’.
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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?
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What do we want?
Computer & software
Acquisition modes?
Application programmes?
Network?
Storage capacity?
Backup?
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What do we want?
More...
Education and training
Payment
Warranty
Reliability
Service and maintenance
List of users
Manuals and other documentation
Time of delivery
Upgradability
Quality control equipment
Acceptance test
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The Tender Document Should
Therefore Include:
•System overview
•Contact persons
•Commercial specifications
•Technical specifications
•Data acquisition and processing
•Electrical and mechanical safety (national regulations)
•Education and training
•Documentation
•Service organization
•Installation and acceptance testing
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What shall the vendor specify?
Commercial specifications:
•Price
•Payment
•Warranty
•Liability insurance for installers
•Right to refuse or remove equipment
•Value of the old camera
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What shall the vendor specify?
Hardware:
•Crystal size and shape
•PM-tubes
•Gantry dimension and weight
•Gantry movements, including autocontour
•Electrical power requirements
•Imaging table
•Collimators and method of change
•Shielding of detector
•Operating console
•Energy windows
•Energy range
•Safety features
•Motion control
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What shall the vendor specify?
Technical performance:
•Linearity
•Uniformity (different energies, different angles)
•Energy resolution
•Spatial resolution (intrinsic and system, planar
and tomographic)
•Count rate performance
•Center of rotation
•Multiple window spatial positioning
•System sensitivity (planar and tomographic)
•Point source sensitivity
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What shall the vendor specify?
Computer system:
•Acquisition modes
•Basic application programmes
•Clinical application programmes
•Quality control programmes
•DICOM-standard
•Network and communication
•Printers
•Storage and backup of patient data
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What shall the vendor specify?
…..and more:
•User lists and site visits
•Reliability (e.g. 95%)
•Service response time and follow up
•Training now and later
•Service manuals
•Upgradability
•Delivery, setup and installation date
•Floor loading, elevators and doors
•Electrical requirements
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End of step 2
Distribute the tender documents to the vendors
RELAX!
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The decision:
Which camera fulfills our
requirements?
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The Decision
• Can the camera and the computer software be used
efficiently for all types of intended examinations?
• Are the technical specifications satisfactory?
• Is the camera easy to handle?
• Is the price reasonable?
• Is the manufacturers service organization satisfactory?
• Is the required training OK?
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Site Visits
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The Decision- End of step 3
Manufacturer 1
Manufacturer 2
+ price
+ technical parameters
- service
- computer system
+ price
- technical parameters
+ service
- computer system
We want that one!!
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Make a clear and detailed specification of the implementation agreement.
• Which are the users responsibilities?
• Which are the vendors responsibilities?
• Which documents are valid?
• Date of delivery?
• Mode of payment?
• Warranty?
Sign the contract
Make the installation
Perform an acceptance test
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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.
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Acceptance Tests
X-ray installations
171
Passed
10
Passed after minor corrections 123
Not passed
38
(SSI 1992)
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QC Gamma Camera
Uniformity
Uniformity, tomography
Spectrum display
Energy resolution
Sensitivity
Pixel size
Center of rotation
Linearity
Resolution
Count losses
Multiple window pos
Total performance phantom
P
P
P
P
P
P
P
P
P
P
P
P
Acceptance
T
T
Daily
T
T
T
T
T
Weekly
P
P
P
P
P
P
P
P
P
P
P
P
Yearly
P: physicist, T: technician
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IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 9.
Quality Assurance
Module 9.6. Education and Training
How to achieve a high standard
of safety in a hospital?
•Safety culture
•Support from the hospital management
•Well educated staff
•Local radiation protection organization
•Quality assurance programme
•Use of authorized services
•Continuing education and training
•Arrangements for individual
monitoring and health surveillance
•Records
•Documented local rules and procedures
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Education and Training
are essential for a
radiation protection programme


Use recommendations as stipulated in ICRP
Publication 113
The relevant plan should include who, where
and when shall be trained.
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Education and Training
(BSS: Interim Edition)
“2.21. The government shall ensure that
requirements are established for:



(a) education, training, qualification and
competence in protection and safety of all persons
engaged in activities relevant to protection and
safety;
(b) the formal recognition of qualified experts;
(c) the competence of organizations that have
responsibilities relating to protection and safety.”
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Education


All staff in nuclear medicine must have
appropriate education to perform their
duties…
For radiation protection purposes this affects
particularly:





Radiation Protection Officer
Physician
Qualified Expert (Medical Physicist)
Nuclear Medicine Technician
….
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Education and Training
Personnel shall be instructed in radiation protection before
assuming duties:
•the conditions of the licence;
•safe use and operation of equipment;
•instructions that should be provided to patients and patient
helpers;
•institutional radiation protection policies and procedures
(including emergency practice drills);
•the local QA programme and QC procedures;
•the results of review and analysis of incidents and accidents
that have occurred in the institution or elsewhere.
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A note of Qualifications of others

There should also be a process in place
which ensures that outside contractors
on whom radiation protection may
depend (e.g. service engineers) are
appropriately trained and qualified.
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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.
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Education and Training
* Basic and continuing training for those who
have responsibilities for the operation of the
equipment or for preparations of radiopharmaceuticals.
* Advanced training for physicians, physicists
and radiochemists.
* Continuing education for those who have
operational responsibilities in a nuclear
medicine facility.
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Continuing Education


It is essential for all staff to have
regular updates on radiation
protection aspects
Continuing education must be
documented
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Education and Training



If the number of professionals is too small
to justify setting up a training course, then
international co-operation programs may
be used
Distance learning programs may be useful
A course such as the present may play an
important role...
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Education and Training
Continuing education in annual refresher training courses, and
whenever there is a significant change in duties, regulations,
terms of the license, or type of radioactive material or
instruments used. Topics should be selected from a syllabus
which has been approved by the RPC.
Today we will
talk about
Patient safety
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Radiation Protection Training
Programme
• Basic radiation physics.
• Biological effects of radiation.
• International standards in Radiation Protection
• Responsibility and duties.
• Safe handling of radioactive materials.
• Occupational radiation protection.
• Medical exposure.
• Management of radioactive waste.
• Protection of the public.
• Emergency preparedness.
• Organization of radiation protection
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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
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Education and Training

The Regulatory Authority should
establish training curricula for (for
example) :
 RPOs
 members
of the RPC
 relevant physicians
 medical physicists
 laboratory staff
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The Role of Regulatory Authority
 Require key personnel (named in RPP) to be duly
accredited/qualified and to have adequate training
in radiation protection.
 Specify/approve minimum training
standards/syllabus content for radiation protection
training courses.
 Provide training courses, perhaps in conjunction
with other contributors, if courses are otherwise
unavailable in the country.
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Continuous Quality Improvement






CQI - many other acronyms are available for this
Part of virtually all QA systems
Improved methods are documented in clinical trial
reports.
Quality assurance protocols are continuously under
development in many countries
Regular Quality Assurance meeting for all members
of a Section
Continuing education - lectures, workshops, journal
clubs and must be available for all staff
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And finally: QA is not a threat, it is
an opportunity
It is essential in a QA program that all
staff feel free to report errors
 A non threatening environment must
exist
 Reward honesty with encouragement
 Education is the key, not punishment

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What is This?
Communication!
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Questions?
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Discussion
How should the quality of a nuclear medicine practice
be measured?
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Discussion
Discuss the responsibilities in QA for the different
members of the nuclear medicine staff.
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Discussion
Which one of the following practices has the
highest quality of the practice:
1. The most modern equipment and unqualified persons
running it.
2. Old equipment and qualified people running it.
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Where to Get More
Information

Further readings




IAEA TECDOC 602
Basic Safety Standards: Interim Edition, 2011
WHO publications
ISO publications
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