Quality Assurance

IAEA Basic Safety Standards

 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.
• The International Organization for Standardization (ISO) defines
quality assurance as all planned and systematic actions needed to
provide confidence that a structure, system or component will
perform satisfactorily in service. Satisfactory performance in
diagnostic nuclear medicine implies the optimum quality of the entire
process, i.e. the “ consistent production of adequate diagnostic
information with minimum exposure of both patients and personnel”.
For therapeutic uses of unsealed radionuclides, quality assurance
refers to “all those procedures that ensure consistency of the
medical prescription and the safe fulfilment of that prescription’.
 Quality Assurance
• Quality assurance should cover:
- The prescription of the procedure by the medical practitioner and
its documentation(supervising if there is any error or contraindication).
- Appointments and patient information.
- Clinical dosimetry.
- Optimization of examination protocol.
- Record keeping and report writing.
- Quality control of radiopharmaceuticals and radionuclide
generators.
- Acceptance and commissioning.
- Quality control of equipment and software.
- Waste management procedures.
- Training and continuing education of staff.
- Clinical audit.
- General outcome of the nuclear medicine service.
 Quality Control
• Definition
The procedures by which the radiopharmaceuticals , instruments,
assay procedures are tested to ensure its appropriate function, e.g.
testing of radiochemical purity, stability, sterility, instruments QC
procedures, QC samples in assay procedures.

• Radiopharmaceutical aspects – toxicity, sterility, and pyrogenicity.

pH, Specific activity, radionuclide purity, radiochemical purity, chemical
purity.
• Instrumentation : Uniformity, Sensitivity, Resolution, Background, PHA
window setting, Position of centre of rotation, Pixel size.
1. Gamma Cameras – (1) Daily - Peaking, Field uniformity.
(2) Quarterly, Semiannually, Periodic– System uniformity for all
collimators. (3) Weekly – Spatial resolution/linearity. (4) Quarterly,
Semiannually, Periodic – Sensitivity. (5) Quarterly, Semiannually,
Annually, Periodic – Dead time/maximum count rate. (6) Quarterly,
Annually, Periodic – Multiple-window spatial registration.
 Quality Control
2. SPECT – (1) Daily – Uniformity, Collimator visual inspection.
(2) Weekly, Biweekly – Center of rotation, Spatial resolution/linearity, High count
flood/uniformity correction map. (3) Quarterly, Annually – Tomographic spatial
resolution. (4) Quarterly, Semiannually – Pixel size. (5) Quarterly – Tilt angle
check. (6) Annually – Collimator hole angulation.

3. PET – (1) Daily – PMT baseline check and gain adjustment, Blank scan,
Uniform cylinder or point source scan. (2) Weekly – Uniformity check, Well
counter calibration check, Coincidence timing check, Energy window calibration.
(3) Quarterly – Preventive maintenance, Detector efficiency/normalization scan,
Cross calibration. (4) Annually – NEMA NU 2-2007 testing ( National Electrical
Manufacturers Association), Update of normalization factors and well counter
callibration.

4. Dose calibrator – (1) Daily – Consistancy. (2) Quarterly – Activity linearity. (3)
Annually – Accuracy.

5. GM survey meter (1) Daily – Battery functionality, Constancy.

(2) Annually – Accuracy/calibration.
 Quality Control
6. Well Counters and Thyroid Probes – (1) Daily – Calibration/Peaking,
Constancy/ Sensitivity. (2) Quarterly/Annually – Energy Resolution.
(3) Monthly/ Quarterly – Chi square test. (4) Annually – Detector
efficiency.

7. Semiconductor Probes (Intraoperative Probes) – (1) Daily – Battery

check, Background determination, Constancy check. (2) Quarterly or
Semiannually – Calibration.

• In vitro RIA, IRMA procedures – (1) Within batch QC-Quality control

samples QC (1) High, QC (2) Normal, QC (3) Low samples at the
beginning, middle and at the end of the assay .
(2) Between batch QC- Comparison of the results obtained in one assay
batch with those obtained in previous batches.( QC chart).
(3) External Quality Assessment Scheme (EQAS) – Provides a means
for independent assessment of laboratory performances.
 QUANUM
• Quality management audits in nuclear medicine practices. A tool to improve
nuclear practice. It is not inspection. It is a Peer Review of QUANUM check
list. They are performed on the request of the corresponding department
after a thorough self evaluation according to the Quanum method.
• Quanum checklist:
1. Strategies and Policies.
2. Administration and Management.
3. Human Resources Development.
4. Radiation Regulations and Safety Compliance.
5. Radiation protection of the patients.
6. Assessment of diagnostic imaging procedures.
7. Assessment of non-diagnostic imaging procedures – Clinical, technical
procedure, patient preparation, reporting and follow up, QA and QC.
8. General radionuclide therapy.
9. Assessment of therapy.
10. Radiopharmacy operational level 1, 2.
 QUANUM
• Identify and review key concepts in the QUANUM process and
relate to the check list.
• Distinguish the different degrees of scoring systems and
conformances as it relates to the check list.
• Appraise the QUANUM Radar plot.
 QUANUM

• Prioritization of Non-Conformance :
(1) Critical priority : issues impacting safety of patients, staff,
and/ or environment that should be promptly addressed (within
days or weeks).
(2) Major priority : issues impacting the capacity of the nuclear
medicine service to adequately perform its activities that should
be addressed in a timely manner (3-6 months).
(3) Minor priority: issues that may be object of optimization, to be
accomplished within a defined time period and re-evaluated
during the next audit.