Detailed breakdown of CLIA calibration verification requirements including frequency, documentation, acceptable performance criteria, and common surveyor findings.
Frequently Asked Questions
How often is calibration verification required under CLIA?
At least every six months for each non-waived quantitative test system, under 42 CFR §493.1255.
What events trigger it outside the six-month cycle?
A reagent lot change when the manufacturer specifies it, major instrument maintenance or repair that could affect performance, and QC results suggesting the calibration may have shifted. Document the trigger with the results.
Which tests require it?
All quantitative non-waived tests reported to patients: chemistry panels, hematology indices with a reportable range, coagulation, and quantitative immunoassays.
What must the record include?
Date, analyst, materials with lot numbers and concentrations, measured results per level, calculated recovery, and the pass/fail determination with criteria applied, reviewed by the medical director or designee.
What is the most common inspection finding?
Incomplete documentation, not the absence of the verification. Missing lot numbers, no pass/fail determination, or no record of who reviewed it.