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    13 - Ch-09 QC Setting 0328

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    Nguyễn Danh Dung
    This document describes the procedure for setting quality control parameters and registering quality control samples in the analyzer. It explains how to specify methods, samples, rules and flags for quality control testing and register QC samples with names and lot numbers.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    13 - Ch-09 QC Setting 0328

    Uploaded by

    Nguyễn Danh Dung
    4 views5 pages
    This document describes the procedure for setting quality control parameters and registering quality control samples in the analyzer. It explains how to specify methods, samples, rules and flags for quality control testing and register QC samples with names and lot numbers.

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    13_Ch-09 QC Setting 0328

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    This document describes the procedure for setting quality control parameters and registering quality control samples in the analyzer. It explains how to specify methods, samples, rules and flags for quality control testing and register QC samples with names and lot numbers.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    4 views5 pages

    13 - Ch-09 QC Setting 0328

    Uploaded by

    Nguyễn Danh Dung
    This document describes the procedure for setting quality control parameters and registering quality control samples in the analyzer. It explains how to specify methods, samples, rules and flags for quality control testing and register QC samples with names and lot numbers.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 5

    Chapter 9.

    Quality Control setting

    Chapter 9 Quality Control setting


    Here is described on the setting procedure to judge the quality of measurements and to
    register the QC samples.

    9.1 Analysis condition setting

    QC(F8) > QC Settings


    Specify the method and the QC sample for analysis.
    It is available to register up to three QC samples per method.
    Specify standard deviation for each method and analysis conditions.

    Figure 9.1-1

    1. Method No.
    Select the Method No. from drop-down menu.
    After selecting the method no., the name is displayed on the Method name.

    2. Sample type
    Select the Sample type (Serum Urine, Plasma, or Others) from drop-down
    menu.

    3. Interval
    Enter the QC validity (from 0 to 999) in minute.
    If "0", no check for QC validity will be performed.

    If the QC validity has expired, the test will be displayed in yellow. The
    measurement results will be added the flag (CXP flag) indicating that the QC
    validity has expired.
    160
    Chapter 9. Quality Control setting

    4. Mode
    Select the mean used as reference for the confidence range from drop-down
    menu.
    z Mean-R The mean value specified for the QC is used as reference.
    It is calculated by the difference between the entered mean
    values.
    z X-R The mean is calculated from the results obtained on the latest
    QC results. The number of QC results used for mean
    calculation must be specified in the No..

    5. No.
    Specify the QC results for calculation (from 1 to 99) when selecting “X-R” in the
    Mode.

    6. QC Sample Name
    Select the QC sample name from drop-down menu.

    7. Mean Value
    Enter the Mean value. (Mean-R)
    When selecting “X-R” in the Mode, the mean value calculated from the
    measurement results is displayed.

    8. SD
    Enter the SD value (from 0.001 to 999.999).

    9. Rules
    They are specified for each QC sample as the target value and the 1 SD value
    in the annex of the QC notice for judgment.
    10 kinds of the error flags or warning flags can be displayed on the results.
    The judgment results are indicated on the result graph with colors on each
    measurement plot.

    z INACTIVE: black
    z WARNING: yellow
    z ERROR: red
    The highest priority error should be displayed if more than two errors or
    warnings have found in the judgment result.

    161
    Chapter 9. Quality Control setting

    Error and warning description Code

    Current result exceeds 2SD 1:2S

    Current result exceeds 3SD 1:3S

    Current result exceeds 4SD 1:4S

    Last 2 results exceeds 2SD 2:2S

    2 in last 3 results exceed 2SD 2/3:2S

    Range exceeds 4SD R:4S

    Any 3 results exceed 1SD 3:1S

    Any 4 results exceed 1SD 4:1S

    Serial 10 results exceed mean 10:X[+], 10:X[-]

    Serial 7 results show increase/decrease 7:T[+], 7:T[-]

    10. Registered QC Samples


    The registered QC sample names are displayed.

    11. Save
    Saves the editing.

    12. Cancel
    Cancels the editing without save.

    13. Print
    Prints the information set on this screen.

    162
    Chapter 9. Quality Control setting

    9.2 QC Sample Registration

    QC(F8) > QC Sample Registration


    This screen is available to register QC sample names up to 40 kinds (from Q1 to Q40).
    The methods for the specified QC sample are displayed.

    Figure 9.2-1

    1. QC Sample ID
    Select the QC Sample ID No. from drop-down menu. (1 to 40)

    2. QC Sample Name
    Enter the QC sample name. (up to 20 alphanumeric characters)

    3. Sample Type
    Select the Sample type (Serum Urine, Plasma, or Others) from drop-down
    menu.

    4. QC Sample Lot. No.


    Enter the lot no. for the QC sample. (up to 6 alphanumeric characters)

    5. Used methods
    The methods corresponding to the specific QC sample are displayed.

    6. Registered QC Samples
    The registered QC sample names are displayed.

    7. Save
    Saves the editing.

    8. Cancel
    Cancels the editing without save.
    163
    Chapter 9. Quality Control setting

    9. Delete
    Deletes the registered QC sample ID.

    <Procedure for deletion>


    1. Select the QC Sample ID No. and press the “Delete” icon.
    2. For saving, press the “Save” icon.
    3. The pop-up message appears for confirmation.
    4. Click the [OK] button to delete the ID. Click the [Cancel] button for
    cancellation.

    164

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