Quality Control Procedures for a Dose Calibrator

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Quality Control Procedures for a Dose Calibrator

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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.

6
LINEARITY 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.

16
ACCURACY 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

19
Quality 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

20
Scintillation 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

21
Quality 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

22
Approaches 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

23
Intrinsic 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

24
Routine 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

25
Signalto Noise Ratio
  • By
  • Chinyere Millington

26
Signal -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.

27
Signal -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.

28
Signal -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.

29
Signal -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.

30
Signal -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.

31
Signal -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.

32
Questions
  • 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.

33
Survey Instruments
  • The interpretation of the studies performed in
    nuclear medicine are done assuming that all the
    systems used are reliable and accurate

34
Quality 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

35
Survey 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

36
Accuracy
  • 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.

37
Accuracy
  • 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

38
Constancy
  • 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

39
Dose 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

40
Accuracy
  • 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

41
Constancy
  • 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

42
Linearity
  • 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

43
Geometric 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

45
NEMA STANDARDS AND THEIR APPLICATION TO NUCLEAR
MEDICINE
Fernando Santiago
46
What 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.

47
What 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

48
An Example of a NEMA Standard?
49
NEMA and NUCLEAR MEDICINE
50
(No Transcript)
51
Dicom 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.

54
THE END
55
QUALITY CONTROL REQUIREMENTS FOR NON IMAGING
SCINTILLATION DETECTORS
  • By Yasnhai Diaz

56
Non 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.

57
Calibration
  • 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.

58
Calibration (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.

59
Reproducitibility
  • 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.

60
Reproducitibility (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.

61
Questions
  • 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

62
Questions
  • 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
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