Date Revised: 06/24/2014 Approved by: Tanya Page, md lab Director Test type



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Title:

Quality Control Procedures for Hemoglobin A1C Testing



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Date Revised:

06/24/2014


Approved by:

Tanya Page, MD Lab Director







Test type: Afinion HbA1C using AS100 Analyzer, Afinion A1C reagent cartridges

Test Method: Quantitative

Control reagents used: Afinion HbA1C control reagent [“CI” and “CII”]

Frequency: Both normal and abnormal controls must be run with each new lot/shipment of cartridges, when test results are questionable, and when training new operators. In addition, monthly controls are performed by the Lab Coordinator.

Precautions: All controls should be performed with the protection of gloves and a clear work space and handled in the same manner as a potentially infectious specimen.

Procedure:

  1. Print a copy of the In-house labs Quality Control log:

\\Inside\Clinic\Back_Clinic\CLIA_Binders\Quality Control Manual\Quality Control Logs\Control_Log_Blank.doc

Record the lot number and expiration date for control reagents and test kits.



  1. Allow the control reagents “CI” and “CII” to reach ambient temperature before using, which takes approximately 30 minutes. Ensure that the two test cartridges are also at room temperature.

    1. If you do not wait for thirty minutes with control reagents, or the two test cartridges have not been warmed to ambient (room) temperature, the analyzer will display an error message. The sample will not be able to be processed.

  2. Mix the control reagent vial “CI” thoroughly by shaking for 30 seconds.

  3. Inspect the vial to make sure that mixture is homogenous.

  4. Uncap the vial and either pipette out a single drop onto a hydrophobic surface OR ensure there is a drop of control mixture pooled in the cap of the control vial.

  5. Remove the capillary collection device from the first test cartridge and carefully hold the tip of the capillary collection device to the drop of control reagent, filling the capillary completely.

    1. The capillary cannot be overfilled or under filled. Use a paper towel to wipe away any excess control reagent from capillary.

    2. The capillary cannot have any residue stuck on or in it.

  6. Insert the capillary collection device into the test cartridge and place the test cartridge in the analyzer.

  7. Using the touch screen, indicate that the test is to be run in the Blue “Control” mode and manually close the lid to the analyzer.

    1. NEVER OPEN THE LID TO THE ANALYZER MANUALLY; use the touch screen to open the lid. The touch screen will prompt you when it is appropriate to open the lid.

  8. When asked for patient ID, input the date with “CI” into the analyzer.

  9. When the analyzer has completed running the test, check the result against the indicated range for “CI” marked on the Afinion controls insert. If the result is not in range, re-test following steps 1-9.

  10. Record the result for “CI” in the controls log, with the date and operator’s initials.

  11. Repeat steps 3-10 using control reagent “CII.”

  12. Check both results with the expected values associated with the current lot of Afinion HbA1C control reagent (see Quality Control manual for current insert).



    1. If any deviations occur, take corrective action. Follow the steps outlined in the flowchart included in the ‘Documentation of Procedures and Machine Maintenance Instructions’ sheet that can be found here:

\\inside\Clinic\Back_Clinic\CLIA_Binders\Quality Control Manual\Quality Control Protocols\quality_control_locations_instructions.docx



JM 06/2014

\\inside\Clinic\Back_Clinic\CLIA_Binders\Quality Control Manual\Quality Control Protocols\AfinionHbA1C.doc






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