Title: Quality Control Procedures for a Dose Calibrator
1- Quality Control Procedures for a Dose Calibrator
2(No Transcript)
3- The quality control program for a Dose Calibrator
consists of a series of procedures that measures
its - Constancy
- Linearity
- Geometry Dependence
- Accuracy
4- CONSTANCY TEST
- Constancy means reproducibility in measuring a
constant source over a long period of time. - Assay at least one relatively long-lived source
such as Cs-137, Co-60, or Co-57 using a
reproducible geometry each day before using the
calibrator. - Use the following procedure
- Assay each reference source, using the
appropriate dose calibrator (i.e., use the Cs-137
setting to assay Cs-137) - Measure background at the same setting, and
subtract or confirm the proper operation of the
automatic background subtract circuit if it is
used.
5- For each source used, either plot on graph paper
or log in a book the background level for each
setting checked and the net activity of each
constancy source. - Using one of the sources, repeat the above
procedure for all commonly used radioisotope
settings. Plot or log in the results. - Establish an action level or tolerance for each
recorded measurements at which the individual
performing the test will automatically notify the
chief technician or authorized user of a
suspected malfunction of the calibrator. These
action levels will be written in the log book or
posted on the calibrator. The regulation requires
repair or replacement if the error exceeds 10
percent.
6LINEARITY TEST
- Linearity means that the calibrator is able to
indicate the correct activity over the entire
range of use of that calibrator. - This test will be done using a vial or syringe of
Tc-99m whose initial activity is at least as
large as the maximum activity normally assayed in
a prepared radiopharmaceutical kit, in a unit
dosage syringe, or in a radiopharmaceutical
therapy dose, whichever is largest. - The test shall continue until the activity
contained in the vial or syringe is smallest
activity assayed, but greater than 10
microcuries. - Linearity test is done at installation and at
least every three months. Repair, replace or a
correction factor is done if the result is
outside plus or minus 10 percent.
7- Decay Method
- Assay the Tc-99m syringe or vial in the dose
calibrator, and subtract background to obtain the
net activity in millicuries. Record the date,
time to the nearest minute, and net activity.
This first assay should be done in the morning at
a regular time, for example, 800 a.m. - If starting at 800a.m., repeat the assay at 200
p.m. Continue on subsequent days until the
assayed activity is less than the minimum
activity normally assayed. For dose calibrators
with a range switch, select the range normally
used for the measurement. - Convert the time and date information recorded
for each assay to hours elapsed since the first
assay.
8- On a sheet of semi-log graph paper, label the
logarithmic vertical axis in millicuries and
label the linear horizontal axis in hours
elapsed. At the top graph, note the date and the
manufacturer, model number, and serial number of
the dose calibrator. Plot the data. - Draw a best fit straight line through the data
points. For the point farthest from the line,
calculate its deviation from the value on the
line. - A observed A line deviation
- A line
- If the worst deviation is more than plus or minus
0.10, the dose calibrator should be repaired or
adjusted. If this cannot be done, it will be
necessary to make a correction table or graph
that will allow you to convert from activity
indicated by the dose calibrator to true
activity - Put a sticker on the dose calibrator that says
when the next linearity test is due.
9- Shield Method
- For initial calibration or reinstallation of the
dose calibrator the decay method will be used to
determine linearity and to establish calibration
factors for shield methods. - The Calicheck device will be used for doing
linearity test of the dose calibrator. These
procedures must be in writing and available for
review by the department. - The Lineator device will be used for doing
linearity test of the dose calibrator. These
procedures must be in writing and available for
review by the department. - A set of sleeves of various thickness will be
used to test for linearity other that the
Calicheck or Lineator device. The sleeves will
be calibrated using the following procedure.
10- Calibration of the Sleeves
- Begin the linearity test as described in the
above decay method. After making the first assay,
the sleeves will be calibrated as follows. Steps
B D below must be completed within six minutes. - Put the base and sleeve one in the dose
calibrator with the vial. Record the sleeve
number and indicated activity. - Remove the sleeve one and put in sleeve two.
Record the sleeve number and indicated activity. - Continue for all sleeves.
- Complete the decay method linearity test steps B
G above. - From the graph made in step D of the decay
method, find the decay time associated with
activity indicated with sleeve one in place. This
is the equivalent decay time for sleeve 1.
Record that time with the data recorded in step
B. - Find the decay time associated with the activity
indicated with sleeve 2 in place. This is the
equivalent decay time for sleeve 2. Record that
time with the data recorded in step C.
11- Continue for all sleeves.
- The table of sleeve numbers and equivalent decay
times constitutes the calibration of the sleeve
set. The sleeve set may now be used to test dose
calibrators for linearity. - Calibration of the Dose Calibrator
- Assay the Tc-99m syringe or vial in the dose
calibrator, and subtract background to obtain the
new activity in millicuries. Record the net
activity. - Steps C E below must be completed within six
minutes. - Put the base and sleeve 1 in the dose calibrator
with the vial. Record the sleeve number and
indicated activity. - Remove sleeve one and put it in sleeve two.
Record the sleeves number and indicated activity. - Continue for all sleeves.
12- On a sheet of semi-log graph paper, label the
logarithmic vertical axis in millicuries, and
label the linear horizontal axis in hours
elapsed. At the top of the graph, note the date
and the model number and serial number of the
dose calibrator. - Plot the data using the equivalent decay time
associated with each sleeve. - Draw a best fit straight line through the data
points. For the point farthest from the line,
calculate its deviation from the value on the
line. - A observed A line deviation
- A line
- If the worst deviation is more than plus or minus
0.10, the dose calibrator should be repaired or
adjusted. If this cannot be done, it will be
necessary to make a correction table or graph
that will allow a conversion from activity
indicated by the dose calibrator to true
activity. - Place a sticker on the dose calibrator that says
when the next linearity test is due.
13- GEOMETRY DEPENDENCE TEST
- Geometry dependence means that the indicated
activity does not change with volume or
configuration. - This test will be done using a syringe that is
normally used for injection. - The following test assumes injections are done
with 3-cc plastic syringes and that
radiopharmaceutical kits are made in 30-cc glass
vials. - If volumes of syringes and vials differ from
above, then the procedures will be changed so
that the syringes and vials are tested throughout
the range of volumes commonly used. - Geometry dependence is done at installation.
Repair, replace or correction factor is done if
outside plus or minus 10 percent.
14- In a small beaker or vial, mix 2 cc of a solution
of Tc-99m with an activity concentration between
1 and 10 mCi/ml. Set out a second small beaker or
vial with non-radioactive saline or tap water. - Draw 0.5 cc of the Tc-99m solution into the
syringe and assay it. Document the volume,
millicuries and record instrument setting. - Remove the syringe from the calibrator, draw an
additional 0.5 cc of non-radioactive saline or
tap water, and assay again. Record the volume and
millicuries indicated.
15- Repeat the process until a 2.0-cc volume has been
assayed. - Select as a standard the volume closest to that
normally used for injections. For all the other
volumes, divide the standard millicuries by the
millicuries indicated for each volume. The
quotient is a volume correction factor. The data
will be graphed with horizontal 10 percent error
lines drawn above and below the chose standard
volume. - If any correction factor are greater than 1.10 or
less than 0.90, or if any data points lie outside
the 10 percent error lines, it will be necessary
to make a correction table or graph that will
allow conversion from indicated activity to
true activity. If it is necessary, label the
table or graph syringe geometry dependence, and
note the date of the test and the model number
and serial number of the calibrator.
16ACCURACY TEST
- Accuracy means that, for a given calibrated
reference source, the indicated millicuries value
is equal to the millicuries value determined by
the National Institute of Standards and
Technology (NIST) or by the supplier who has
compared that source to a source that was
calibrated by the NIST. - At least two sources with different principal
photon energies (such as Co-57, Co-60, or Cs-137)
will be used. - One source will have principal photon energy
between 100 keV and 500 keV. - If a Ra-226 source is used, it will be at least
10 microcuries other sources will be at least 50
microcuries. - Use at least one reference source with an
activity in the range of activities normally
assayed. - Accuracy test is done at installation and
annually thereafter. Repair or replace if outside
plus or minus 10 percent.
17- Assay a calibrated reference source at the
appropriate setting (i.e., use the Co-57 setting
to assay Co-57), and then remove the source and
measure background. Subtract background from the
indicated activity to obtain the net activity.
Record this measurement. Repeat for a total of
three determinations. - Average the three determinations. The average
value should be within 10 percent of the
certified activity of the reference source,
mathematically corrected for decay. - Repeat the procedure for other calibrated
reference sources. - If the average value does not agree, within 10
percent, with the certified value of the
reference source, the dose calibrator must be
repaired or replaced.
18- QUESTIONS
- List the series of Quality Control Procedures for
a Dose Calibrator. - Answer Accuracy, Linearity, Geometric
Dependence, Constancy - When would an Accuracy Test Procedure be done ?
- Answer At installation and annually thereafter.
- When would a Linearity Test Procedure be done ?
- Answer At installation and at least every three
months. - When would a Geometric Dependence Test Procedure
be done ? - Answer At installation and after it is
repaired. - When would a Constancy Test Procedure be done ?
- Answer Every day
19Quality Control
- Quality control is the term used to refer to the
routine assessment of instrument performance in
nuclear medicine - Quality control procedures should be used to
establish a baseline level of performance - Action levels are required by the Society of
Nuclear Medicine
20Scintillation Camera Quality Control
- The performance of a scintillation camera system
must be assessed each day to assure the
acquisition of diagnostically reliable images - The most useful data to determine acceptability
of camera performance reflect the parameters of
field uniformity, spatial resolution, and
linearity
21Quality Control Tests
- Uniformity
- The ability of a camera to depict a uniform
distribution of activity as uniform - Spatial resolution
- A transmission phantom consists of some pattern
in lead, the alternating patterns produce closely
spaced areas of differing activity levels - Linearity
- The ability to reproduce a linear activity source
as linear in the image
22Approaches to Camera Quality Control
- Three major factors that are essential to a good
quality control program - Which radionuclides to use
- Whether to test intrinsically, extrinsically, or
a combination of the two - Which phantoms to use
23Intrinsic versus Extrinsic testing
- Intrinsic testing, measuring the performance of
the system without the collimator - The advantage is that a uniform radiation field
is obtained using a small source, the
disadvantage is that the person performing the
test will receive radiation
- Extrinsic testing, evaluation of the entire
system including the collimator - A uniform radionuclide distribution is placed on
the collimator, a sheet source or a flood phantom
24Routine Camera Quality Control Procedures
- Photopeak settings, the correct energy window for
the radionuclide being used must be selected - Orientation controls, must remain constant to
ensure the same detector area is always recorded - Intensity and image size, have a significant
impact on interpretation, so the same parameters
should be used
- Uniformity, using either an extrinsic or
intrinsic method - Linearity and resolution should be checked weekly
- Collimators should be checked for faults of
damage
25Signalto Noise Ratio
26Signal -to- Noise Ratio
- In general, the quality of an image can be
described by its signal-to-noise ratio (SNR). - The SNR directly affects the diagnostic and
quantitative accuracy. - It describes the relative strength of the desired
information and the noise in an image.
27Signal -to- Noise Ratio
- For example, the only was lesions can be detected
is if their activity is sufficiently different
from that of the surrounding tissue. - The greater the contrast between the lesions and
the surrounding tissue, the greater the signal.
28Signal -to- Noise Ratio
- The noise in an image is as a result of
statistical fluctuation within lesion and
surrounding tissue. - If there are few counts in a image, the
fluctuation will be large. - In this case, someone viewing this image would
not be able to recognize the lesions as being
different from the rest of the tissue.
29Signal -to- Noise Ratio
- To achieve a high SNR, high resolution and high
sensitivity are required. - The ratio can be increased by either increasing
contrast or decreasing noise. - A technologist will find the concept of SNR very
helpful in optimizing acquisitions and processing
protocols.
30Signal -to- Noise Ratio
- Since the goal is to maximize an images SNR, an
optimum choice of collimator should be used which
can preserve contrast, while providing
sufficiently sensitivity to keep image noise to
an acceptable low level. - An optimum reconstruction filter may also be used
in order to improve the SNR.
31Signal -to- Noise Ratio
- Speaker Notes
- A major goal of nuclear medicine imaging
equipment is to maximize the SNR in an image. - The response of the imaging system to a point
source of activity can indicate the ability of
the system to perceive signal. - The ability to perceive hot spots from background
can be used to convey if there is good image
quality. - By increasing either the contrast (through
improved spatial resolution) or decreasing noise
(through increased sensitivity), the SNR can be
increased. - Usually the choice that maximizes SNR falls
between the highest resolution choice and the
highest sensitivity choice.
32Questions
- True / False
- The SNR has little affect on diagnostic and
quantitative accuracy. - Answer false (directly affects
accuracy) - The ---------- the contrast between the lesions
and the surrounding tissue, the greater the
---------. - Answer greater, signal
- List two things which are required to achieve
high SNR. - Answer high resolution, high
sensitivity - True/ False
- The less counts in an image, the larger the
fluctuation within body tissue, therefore the
better the image quality. - Answer false (if fluctuation is
large, will not be able to recognize difference
between lesions and surrounding tissue ) - State two ways in which a technologist can
maximize an images SNR. - Answer by choosing an optimum
collimator and reconstruction filter.
33Survey Instruments
- The interpretation of the studies performed in
nuclear medicine are done assuming that all the
systems used are reliable and accurate -
34Quality Control
- Quality control sometimes called QC, is the term
used to refer to the routine assessment of
instruments performance in nuclear medicine. It
is very important. - Once acceptance tests are completed and it is
determined that the camera is satisfactorily
operating and meets the vendors specifications. - Quality control procedures should be used to
establish a baseline level of performance - Quality control procedures are then used each
day to monitor the continued performance of the
instrument
35Survey Meter
- Two types of survey instruments are commonly
used - The cutie-pie, it has an ionization chamber for
areas of high levels of x-rays or gamma-rays - The Geiger-Mueller counter is used for lower
levels of radiation because of its higher
sensitivity - They both require an annual calibration and a
daily constancy testing with long lived
radionuclide standards
36Accuracy
- Survey instruments are calibrated before first
use, annually and after repair - Calibration is performed at two different
operating points of the instruments scale, 1/3
and 2/3 of the full scale - The standard used must be traceable within 5
accuracy to the NIST, (National Institute of
Standards and Technology) - Many departments send their instruments out for
calibration because they do not wish to keep a
standard source on hand.
37Accuracy
- Differences
- Ionization chambers respond in proportion to the
total energy deposited in the detector, and it
can be related to exposure rate, no matter what
the energy of the incoming photon - Geiger-Mueller detectors produces pulses with
sizes that are independent of energy deposited.
Count rate may only be related to exposure rate
if the energy of the radiation is known. This can
be done if the photon energy used to calibrate
the detector is the same as the source measured
38Constancy
- A reference with a long half life must be used to
check the constancy of the survey meter
performance - Initial measurement of the source (CPM) or
exposure rate (mR/hr) is made at time of
calibration and should be noted on the instrument - The source is checked with the same source each
day the instrument is used, after battery change
and maintenance - If the exposure rate or cpm is not within 10 of
expected results, it should be recalibrated
39Dose Calibrator Quality Control
- The accuracy of the dose of radiopharmaceutical
given to the patient depends on the performance
of the dose calibrator - Tests performed
- Accuracy
- Constancy
- Linearity
- Geometric calibration
40Accuracy
- The instrument accuracy test is performed after
installation and annually after that. - Accuracy is tested with at least two sealed
reference standards whose activity is traceable
to the NIST. - Several radionuclide such as Co 57, Cs 137 and Ba
133, may be used - Activity should be between 50 µCi and 200 µCi or
more - At least one of the sources must have a principal
photon energy between 100 keV and 500 keV
41Constancy
- Is checked each day the instrument is used
- After accuracy of the dose calibrator has been
determined, the constancy of the performance is
monitored by daily testing with a long lived
standard, preferably Cs 137 and a control chart
is established - The activity level of the standard is calculated
using the proper decay schedule and plotted in
semi-logarithmic paper. - Points are connected with a straight line which
indicates the decay of the standard, to other
lines are drown indicating the tolerance level
that should not exceed 10
42Linearity
- Is measured at installation and quarterly there
after. - Dose calibrator must function linearly over the
high range doses and 30 µCi - Linearity can be tested by the use of Tc99m with
a half life of 6.01 hrs. we measure its activity
twice a day and plot the readings on a chart, it
is a slow procedure. - Other method that is faster uses a set of
calibrated lead attenuation sleeves to asses
changes in linearity -
43Geometric Calibration
- After installation, if a change is made in the
type of vial or syringe used in
radiopharmaceutical processing and after repair. - To measure the effect of changing the volume of
liquid within a vial a 30ml vial containing a
1mCi of Tc99m in a volume of 1 ml is used - This is assayed, and de volume is increased with
water in steps of 1, 4, 8, 10, 15, 20, and 25 ml,
The net activity of each volume is determined by
subtracting the background - One of the volumes should be selected as standard
and the correction factor for each of the other
volumes can be calculated - One can calculate the true activity of the sample
by taking the correction factor determined for
that volume times the measured activity of the
sample
44- Questions
- Quality control is sometimes called?
- QC
- At what level of the full scale is calibration
performed? - 1/3 and 2/3
- At what level of error should an instrument be
sent for recalibration? - 9.99 10.01 11 10
- How often should linearity test be performed?
- After installation and quarterly thereafter
- When should constancy check be performed?
- Everyday before use
45NEMA STANDARDS AND THEIR APPLICATION TO NUCLEAR
MEDICINE
Fernando Santiago
46What Is NEMA?
- NEMA, was born on Sept.1, 1926 by the merger of
the - Electric Power Club and the Associated
Manufacturers of Electrical Supplies. It
provides a forum for the standardization of
electrical equipment, enabling consumers to
select from a range of safe, effective, and
compatible electrical products. - NEMA publishes over 500 standards and offers them
for sale through Global Engineering, along with
certain standards originally developed as
American National Standards Institute (ANSI) or
International Electrotechnical Commission (IEC)
standards. - Click On This Picture To Learn More
- About the History of NEMA.
47What is a NEMA Standard?
- Each NEMA standard is identified by number and
date and there are five basic steps to creating a
new standard. They are - 1) Project initiation
- 2) Developing the draft
- 3) Balloting (gathering comments)
- 4) Codes and Standards Committee approval
- 5) Editing and Publication
48An Example of a NEMA Standard?
49NEMA and NUCLEAR MEDICINE
50(No Transcript)
51Dicom tries to standarize images in the manner
in which they are taken, stored, converted
into other formats and how they are shared or
how they are transmitted between different
media.
52- The DICOM Standard facilitates interoperability
of medical imaging equipment by specifying - A set of protocols to be followed by devices
claiming conformance to the Standard. - The syntax and semantics of commands and
associated information which can be exchanged
using these protocols. - The information that must be supplied with an
implementation to which conformance to the
Standard is claimed.
53- The DICOM Standard does not specify
- The implementation details of any features of
the Standard on a device claiming conformance - The overall set of features and functions to be
expected from a system implemented by integrating
a group of devices each claiming DICOM
conformance. - A testing validation type of procedure to assess
an implementation's conformance to the Standard.
54THE END
55QUALITY CONTROL REQUIREMENTS FOR NON IMAGING
SCINTILLATION DETECTORS
56Non imaging scintillation detectors
- are used for sample counting, their reliable
performance is essential for accurate results in
a variety of in vivo and in vitro studies.
57Calibration
- Quality control of detectors usually involves
calibration in which the pulse height units and
energy is determined by selection of a narrow
width(10 pulse height units). - The pulse height spectrum is obtain for a long-
lived radionuclide( Cs 137). - The QC test requires that the source be
positioned in the center of the detector.
58Calibration (cont..)
- The voltage or gain setting the yields the
maximum or peak count must be recorder in the
daily calibration log. - Background counts accumulated are recorded as
well. - This procedure must be perform at installation
and annually thereafter.
59Reproducitibility
- The ability of the instrument to reproducibly and
reliably record and display events detected can
be assessed by performing standard statistical
fits of repetitive sample counts obtained using a
radioactive source. - The most prevalent statistical models used are
the chi-square test.
60Reproducitibility (cont..)
- It is sufficient to perform this test initially
when the program begun or when a new instrument
is placed in use. - The data should be also recorded and used for
comparison at least twice per year and whenever
the instrument is suspected of malfunctioning.
61Questions
- T/F
- Scintillation detectors are used for sample
counting, their reliable performance is essential
for accurate results in a variety of in vivo and
in vitro studies. - TRUE
- 2. The QC test requires that the source be
positioned in the center of the detector. - TRUE
62Questions
- 3. Calibration must be perform at installation
and annually thereafter. - TRUE
- 4. Background counts does not accumulate and
does not need to be recorded in a log book. - FALSE
- 5.Reproducibility must to perform initially when
the program begun or when a new instrument is
placed in use. - TRUE