D.8 SOP-0948 Alere hCG External QC Procedure 02.pdf

Pathology & Laboratory Medicine VA Salt Lake City Health Care System, MC 113 Authorized by Chief of Pathology 500 Foothill Drive, Salt Lake City, UT 84148

Document Management Number: SOP-0948

Document Title: Alere hCG External QC Procedure

Principle:

External Liquid Quality Controls are used to assure that the reagents are performing properly and that the analyst is correctly performing the test procedure. The external controls should be tested with each new lot, shipment of test materials, and monthly. For this purpose, use the MAS® UA Controls (Level 1 and 2), located in the Ancillary

Testing Refrigerator. The Controls will be tested and must provide the expected results before placing new kit shipment/lot number into place for patient use.

The Community Based Outpatient Clinics (CBOC), will run monthly External Liquid

Quality Control each time they receive a new shipment from the main laboratory in Salt

Lake City, each new lot, and monthly. The CBOC’s will use the MAS® UA Controls

Level 1 and 2 to test their kits. The Controls will be tested and must provide the expected results before placing new kit shipment/lot number into place for patient use.

Materials:

1. Alere™ hCG Combo Cassette kit

2. MAS® UA Controls

3. Alere™ hCG Combo Cassette External QC Log OFRM-POC-029

Storage and Stability:

When stored refrigerated, the unopened controls are stable until the manufactures expiration date. Once opened, the controls are stable at refrigerated storage temperatures for 90 days from the date of opening or until the manufacturer’s expiration date, whichever comes first. At room temperature the controls are stable for 6 weeks or until the manufacturer’s expiration date, whichever comes first. These products should never be stored frozen.

Procedure:

Upon receipt of a new Alere™ hCG Combo Cassette kit shipment/lot, the lot will be checked with controls and written on the Alere™ hCG Control Log sheet. This testing will be performed by the Ancillary Testing Coordinator or the nursing staff at each

CBOC before the lot is placed into use for patient testing.

1. Allow the Controls to reach room temperature for at least 30 minutes before testing.

2. Remove two Alere™ hCG Combo Cassettes and pipettes from their foil pouches and place them on a clean, dry, level surface.

3. Label one cassette positive QC and the other negative QC.

4. Gently mix each control solution by swirling or inversion. DO NOT SHAKE.

5. Apply 3 drops of the MAS® UA Control Level 2 to the cassette labeled positive

QC, and 3 drops of the MAS® UA Control Level 1 to the other cassette labeled negative QC.

6. Wait 3 minutes.

7. Interpret the results, D.8 SOP-0948 ALERE HCG EXTERNAL QC PROCEDURE

36C25923R0008

Pathology & Laboratory Medicine VA Salt Lake City Health Care System, MC 113 Authorized by Chief of Pathology 500 Foothill Drive, Salt Lake City, UT 84148

• The MAS® UA Control Level 2 must test Positive

• The MAS® UA Control Level 1 must test Negative

8. If the controls fail, contact the Lab Supervisor, and call Technical Support.

Patient testing cannot be performed on this kit lot until the problems are resolved.

9. Log the results, lot numbers, and kit expiration date in the log book.

Review of the QC Data:

Monthly the Ancillary Testing Coordinator will:

• Review and sign the QC log for the hospital use.

• Receive faxed results of Alere™ hCG Combo Cassette External QC Log after lead staff at the CBOC’s review their own QC log for acceptability.

Revision History

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02/02/2017

Hung Ho

E. Hart MD

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02/02/2017

Hung Ho

E. Hart MD