Frequency Of Qc Testing - Saladax MyCare Insite User Manual

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Compare the QC result to the range in the MyCare Psychiatry Control Kit 2 package insert (MCP2-CON). If the
result is not in range, perform the following:
1.
Verify that the control materials have been stored according to the directions and that the open vial
stability duration and expiration date have not been exceeded
2. Verify that the handling and testing procedures were performed according to the directions in the
package insert and instructions at MyCareInsite.com
3. Verify that the operator had passing control results during training
4. Repeat the control test, using a new control from the same lot
If all instructions have been followed but control results are still not within range, please
contact your Official Saladax Distributor for assistance before testing any patient
samples.

Frequency of QC Testing

All quality control requirements and testing should be performed in accordance with local, state and/or
federal regulations or accreditation requirements.
QC testing is recommended when:
Testing patient samples (at least once a week)
A new test box is opened
A new shipment or lot is used
There is an unexpected patient result
New users are trained
The Insite is installed
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