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The IAC Standards
and Guidelines |
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1.1B Equipment
and instrumentation used in the nuclear medicine facility must be in good
working condition and must be routinely inspected for safety and proper
functionality and records kept on file.
1.1.1B All
imaging and non-imaging devices must be FDA-approved or used under an approved
research protocol with informed consent by the patient.
1.1.2B The
facility must maintain records of service and maintenance.
1.1.3B Equipment
and instrumentation must include at least the following:
1.1.3.1B dose
calibrator or decay correction calculation system, as applicable;
1.1.3.2B imaging/counting
equipment;
1.1.3.3B radiation
monitoring devices including:
i. portable
survey meter (required);
ii. removable
contamination counting equipment (as applicable);
iii. fixed
area survey meter for dose preparation/storage areas (as applicable).
1.1.3.4B resuscitation
equipment and supplies (appropriate to the types of procedures being
performed):
i. oxygen;
ii. defibrillator/AED;
iii. emergency
drugs (including a master list; all unexpired).
1.1.3.5B exercise
equipment (as applicable);
1.1.3.6B ECG
equipment (as applicable);
1.1.3.7B ancillary
monitoring equipment (as applicable);
1.1.3.8B infusion
pumps/automated injectors (as applicable);
1.1.3.9B glucometers
(as applicable);
1.1.3.10B hood for
volatile radionuclides or cell handling (as applicable);
1.1.3.11B xenon (or other gas) trap (as applicable).
1.1.3.12B Rubidium Rb82 generator and direct infusion system (as applicable).
1.2B The facility must have acceptable
site-specific written protocols for all routine quality control procedures of
imaging and non-imaging equipment.
Comment:
Simply stating “following manufacturer’s recommendations” is
not sufficient.
1.2.1B The facility must maintain records of
all routine quality control of imaging and non-imaging equipment.
1.2.1.1B Protocols
for quality control of imaging equipment must be step-by-step,
camera-specific and include:
i. frequency of test performance;
ii. type of source and position (e.g.,
point, sheet), if applicable;
iii. equipment setup (e.g., intrinsic,
extrinsic, collimator, energy window setting, matrix size, zoom, etc.);
iv. acquisition instructions including
views, time/counts, etc.;
v. processing instructions, if applicable
(e.g., region of interest for quantification, sinogram generation, graphs,
etc.);
vi. evaluation and
acceptable range (or tolerance limits) of the results of each procedure;
vii. instructions
for corrective action of out-of-tolerance results;
viii. instructions
for retention and comparison with previous results.
1.2.1.2B Protocols for quality control of non-imaging equipment must be step-by-step and include:
i. frequency of testing performance;
ii. sources to be used, if applicable;
iii. data to be collected with acceptable ranges and timing required;
iv. instructions for corrective action of out-of-tolerance results.
1.2.1.3B The
results of QC testing must be reviewed by appropriate staff in a timely manner
and action taken if results are not within tolerance limits.
1.2.1.4B Quality control protocols must be reviewed and/or updated as equipment is
changed and at least every three years by the Medical Director,
physicist or other responsible person.
1.2.2B If
frequency of QC testing varies from the above, justification must be based on
scientific data or manufacturer’s recommendation. If a less frequent
schedule is being used, there must be clear documentation of the justification
(such as based on scientific data).
1.2.3B Appropriate
reference standards (i.e., sealed sources) for QC of imaging and non-imaging
equipment must be used with a reference source traceable to the National
Institute of Standards and Technology (NIST).
(See Guidelines below for further recommendations.)
1.3B Site-specific, detailed protocols must be documented and
followed for routine inspection and testing of all imaging equipment. Protocols
must be in accordance with all applicable federal, state and local
requirements.
1.3.1B Gamma
Camera (Planar, SPECT, and SPECT/CT)
1.3.1.1B Energy
peaking to verify that the photopeak is centered in the set photopeak energy
window must be performed, if applicable (documentation not required).
Frequency: Daily (prior to use) or per manufacturer’s recommendation
1.3.1.2B Intrinsic
or extrinsic uniformity calculation of integral and/or differential uniformity
value must be performed (e.g., 3-5%).
Frequency: Daily (prior to use)
1.3.1.3B Spatial
resolution/spatial linearity with resolution phantom (e.g., bars) must be
performed.
Frequency: Weekly
1.3.1.4B Center-of-rotation
(COR) must be performed on
SPECT cameras to ensure mechanical and electrical alignment of the
center of field of view.
Frequency: Monthly
1.3.1.5B High-count
flood for uniformity correction, performed to correct for residual detector and
collimator non-uniformity, must be performed.
Frequency: Per manufacturer’s recommendation
1.3.1.6B Preventive
maintenance (PM) must be performed.
Frequency: Every six months
1.3.1.7B For SPECT/CT
equipment, daily system tests (as recommended by the manufacturer) must be
performed to assess system function/constancy (e.g., calibration scan, CT
warm-up, CT calibration, water phantom, coincidence timing, normalization
update, etc.). The daily system test procedure must be specifically described.
Comment:
Energy peaking and uniformity testing must be appropriate for the energy of the
radioisotopes being imaged (e.g., low energy or medium energy).
Comment:
If imaging equipment is physically moved from site to site, (other than planar
mobile gamma cameras or non-PMT mobile planar/SPECT cameras used within a
building) the QC tests must be repeated after each move and prior to equipment
use.
(See Guidelines below for further recommendations.)
1.3.2.1B Daily system tests (as recommended by
the manufacturer) must be performed to assess system function/constancy (e.g.,
calibration scan, blank scan, CT warm-up, CT calibration, water phantom,
coincidence timing, normalization update, etc.). The daily system test
procedure must be specifically described.
Frequency: Daily (prior to
use)
1.3.2.2B Tomographic
uniformity using a cylinder phantom of uniform radioactivity must be performed.
Frequency: Per manufacturer’s recommendation
1.3.2.3B Normalization
to calibrate the efficiency of all detectors in the system must be performed.
Frequency: Per
manufacturer’s recommendation and after preventive maintenance and major
hardware repair.
1.3.2.4B For facilities
performing quantitative analysis of images, such as standardized uptake value
(SUV) calculation, absolute activity calibration and testing must be performed.
Facilities must develop procedures that validate quantitative scanner
performance.
Frequency: After a hardware change or per manufacturer’s recommendations
1.3.2.5B Preventive
maintenance of all PET and PET/CT scanners must be performed. Frequency: Every
six months
Comment: If the PET or PET/CT scanner is physically moved from
site to site, the daily system
test as described in Standard 1.3.2.1B must be performed after each scanner
relocation and prior to injection.
(See Guidelines below for further recommendations.)
1.3.3B CT-Specific
Quality Control - Please refer to the IAC Standards and Guidelines for CT
Accreditation for
specific quality control requirements for CT scanners.
1.4B Site-specific,
detailed protocols must be documented and followed for routine inspection and
testing of all non-imaging equipment. Protocols must be in accordance with all
applicable federal, state and local requirements.
1.4.1.1B Constancy
of response must be checked by measuring the exposure or counting rate of a
long-lived reference source. Measurements must be within acceptable tolerance
levels (e.g., within 10-20%).
Frequency: Daily or prior to use or per manufacturer’s recommendation
1.4.1.2B The
battery must be checked, if applicable, to verify the voltage supplied by the
battery is within the acceptable operating range.
Frequency: Daily or prior to use
1.4.1.3B The
survey meter must be calibrated using suitable long-lived reference sources.
Frequency: Annual or following repair as per manufacturer’s recommendation
(See
Guidelines on Page 40 for further recommendations.)
1.4.2.1B Background exposure must be measured
Frequency: Daily or before
use
Comment:
This must include daily quality control as required by the manufacturer’s
recommendations.
1.4.2.2B Constancy
of response must be checked by measuring the exposure or counting rate of a
long-lived reference source. Measurements must be within acceptable tolerance
levels (e.g., within 5-10%
or per
manufacturer’s recommendation).
Frequency: Daily or before use
1.4.2.3B Linearity
that is within tolerance limits must be verified (e.g., within 10%). Method of
linearity check (i.e., decay or shield method) including activity, volume, time
of measurement, etc., must be specifically defined.
Frequency: Quarterly
1.4.2.4B Accuracy
that is within tolerance limits must be verified (e.g., within 5-10% or per manufacturer’s
recommendation).
Frequency: Annual
(See Guidelines below for
further recommendations.)
1.4.2.5B Measurement
of geometry dependent responses that affect volume changes of vials and/or syringes must be
performed.
Frequency: At installation and following repair or relocation as per manufacturer’s
recommendation.
1.4.3.1B Energy
spectrum check, if applicable, to verify that the counter is properly peaked
and that the photopeaks of the radionuclides coincide with the preset photopeak
energy windows.
Frequency:
Daily or per manufacturer recommendation
1.4.3.2B Background
exposure or counting rate must be measured.
Frequency: Daily (or prior to use)
1.4.3.3B Constancy
of response must be checked by measuring the exposure or counting rate of a
long-lived reference source. Measurements must be within acceptable tolerance
levels (e.g., within 5-10%
as per manufacturer’s recommendation).
Frequency: Daily (or prior to use)
1.4.3.4B Chi-square
(X2) test, if applicable, to measure reproducibility and random variation must
be performed.
Frequency: Quarterly
1.4.3.5B Efficiency
to determine the ratio of
detected counts measured by the system to the actual rate of decay (cpm/mCi or
dpm), for a specific nuclide or region of interest must be performed.
Frequency: Annual or per manufacturer’s recommendation
1.4.4.1B The
battery must be checked to verify the voltage supplied by the battery is within
the acceptable operating range.
Frequency: Daily or before
use
1.4.4.2B Background
exposure or counting rate must be measured.
Frequency: Daily or before
use
1.4.4.3B Bias
voltage of primary and back-up battery must be checked, if applicable.
Frequency: Per manufacturer’s recommendation
1.4.4.4B Constancy
of response must be checked by measuring the exposure or counting rate of a
long-lived reference source. Measurements must be within acceptable tolerance
levels (e.g., within 5-10%
or as per
manufacturer’s recommendation).
Frequency: Daily or before
use
1.4.5B Organ
Uptake Probes (e.g., thyroid uptake probes)
1.4.5.1B System Test/Detector
Status/Autocalibration (as recommended by manufacturer) must be performed to
assess internal data, full width half-maximum (FWHM), voltage and gain settings.
Frequency: Daily or before
use
1.4.5.2B Energy
spectrum check, if applicable, to verify that the counter is properly peaked
and that the photopeaks of the radionuclides coincide with the preset photopeak
energy windows.
Frequency: Daily or before
use
1.4.5.3B Background
exposure or counting rate must be measured.
Frequency: Daily or before
use
1.4.5.4B Constancy
of response must be checked by measuring the exposure or counting rate of a
long-lived reference source. Measurements must be within acceptable tolerance
levels (e.g., within 5-10%
or as per
manufacturer’s recommendation).
Frequency: Daily or before use
1.4.5.5B If probe
is used to perform radioactive contamination wipe tests, efficiency for a specific nuclide or region
of interest must be measured to determine the ratio of detected counts measured
by the system to the actual rate of decay (cpm/Bq or cpm/mCi) or disintegrations
per minute (dpm).
Frequency: Annual or per manufacturer’s recommendation
1.4.5.6B Chi-square (X2) test to measure
reproducibility and random variation must be performed.
Frequency: Quarterly
1.4.6B Organ
Uptake Probes (e.g., thyroid uptake probes)
1.4.6.1B System Flush
Frequency: Daily or before
use
1.4.6.2B Dose Calibrator Calibration
Frequency: Daily or before
use
1.4.6.3B Sr breakthrough testing
Frequency: Daily or before
use
1.4.6.B Generator Replacement / Installation
Frequency: Per viable life of generator
1.5B Site-specific,
detailed protocols must be documented and be followed for routine inspection
and testing of all other medical equipment. Protocols must be in accordance
with all federal, state and local requirements.
1.5.1.1B An
emergency response cart or kit, appropriate for the types of procedures being
performed, must be present. There must be documentation that it is checked to
assure that all expected items are present and none is expired.
Frequency: Monthly
1.5.1.2B Defibrillator/AED
device and supplies (e.g.,
pads, gel) must be checked for functionality (e.g., voltage and battery,
expiration date)
Frequency: Daily when
patient studies are performed
1.5.1.3B Oxygen
sources (wall unit or portable cylinder) must be checked for availability, pressure gauge shows adequate
tank filling, proper function and proper tubing/mask.
Frequency: Daily when
patient studies are performed
1.5.2B Miscellaneous
Equipment
1.5.2.1B Glucometer
accuracy must be confirmed.
Frequency: Daily if used
1.5.2.2B Infusion
pump accuracy must be confirmed.
Frequency: Per manufacturer’s recommendation
1.5.2.3B Xenon
trap and nebulizer
i. Nebulizer
must be visually inspected for damage and cleaned.
Frequency: As necessary
ii. Xenon
trap moisture absorbing crystals must be replaced (e.g., every 3-5 patients).
Frequency: Per manufacturer's recommendation
iii. Xenon
trap leak test must be performed.
Frequency: Monthly
iv. Xenon
trap/charcoal filters must be replaced.
Frequency: Per manufacturer’s recommendation
1.2B For
each quality control test performed, the following information should be
recorded:
· the test
performed;
· date and time of
the test;
· identification of
the device tested (e.g., make, model);
· the make, model
and serial number of any reference sources used, if applicable;
· the results of the
test;
· a notation
indicating if the test result was or was not acceptable;
· the signature or
initials of the individual performing the test or clear delineation of this
duty written into a policy.
Comment:
Preferably, the information is recorded on a structured form or documented in a
facility management program.
Initial
acceptance results for all equipment should be retained and used for
comparison. Preferably, acceptance testing should be performed by a party other
than the equipment supplier
1.3.1B Gamma
Camera:
Overall
system performance may be evaluated using a fillable phantom containing
non-radioactive (cold) inserts of different sizes and visually inspecting the
resulting images.
Frequency: Annually
Collimator
integrity, comparing the extrinsic and intrinsic uniformity flood along with
visual inspection of collimator for damage, should be performed.
Frequency: Annually
1.3.2B PET
and PET/CT Scanners:
Bed
position overlap (e.g., 2-bed test, continuous bed motion, incremental bed
overlap) is recommended. Frequency: Per manufacturer recommendation
Alignment
of the PET and CT scans (for PET/CT scanners) should be performed as per
manufacturer recommendation.
Frequency: Per manufacturer recommendation
1.4.1.3B Survey
Meter - A dated sticker summarizing the calibration results should be
affixed to the meter itself. The calibration report should specify the
reference sources, the measurement procedure and the measured and expected
exposure rates.
1.4.2.4B Dose
Calibrator - It is preferable that accuracy be measured with at least two
reference sources.