QUALITY CONTROL

The XW-100 analyzer enforces QC to be successfully run at least every 8 hours. The analyzer is locked out from patient testing until QC is passed for all three levels of control. The analyzer does not display or print QC results. The analyzer was designed this way to meet the CLIA waiver definition of “simple” and to ensure operators must comply with QC rules.

Three levels of QC must be performed as follows:

Every 8 hours of instrument use
When a new lot of reagent is used
After completing weekly care

Whenever the analyzer prompts “QC Is Required”

The system will not allow patient samples to be tested
until QC is passed.

QC data is not available for audits. QC results are interpreted by the analyzer and not by the operator. The analyzer does not display or print QC results. The analyzer was designed this way to meet the CLIA waiver standards of simplicity and to ensure operators must comply with QC rules.

The acceptability of QC results is interpreted by the analyzer software and not the operator in the waived setting. If QC does not pass, the operator is locked out and patient testing is prevented.

Running Quality Control