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AMR Verification Template — CLSI EP06 | CAP · COLA · CLIA Compliant
Before your lab can report a patient result, CLIA (42 CFR §493.1253), CAP, and COLA require you to verify that your instrument can accurately measure across its full claimed reportable range — the Analytical Measuring Range (AMR). Skip this step, and you're out of compliance on day one.
This Excel template walks you through a complete AMR (reportable range) verification per CLSI EP06, using linearity materials or dilution series you already have on hand. No EP Evaluator subscription required.
What's included:
Dual acceptance evaluation: linearity (slope, R², auto-calculated) and percent recovery at each level
AMR span coverage check — confirms your test materials actually reach the upper and lower AMR limits claimed by the manufacturer
Up to 8 concentration levels with triplicate entry
Configurable acceptance limits sourced from the manufacturer package insert
Auto Pass/Fail at every level and for the overall study
Full compliance statement and lab director attestation section
Detailed instructions referencing CLIA §493.1253, CAP GEN.41056, and COLA Principle 7
Designed for FDA-cleared, non-waived, moderate complexity quantitative assays. Suitable for initial instrument verification and periodic re-verification.
AMR Verification Template — CLSI EP06 | CAP · COLA · CLIA Compliant
Before your lab can report a patient result, CLIA (42 CFR §493.1253), CAP, and COLA require you to verify that your instrument can accurately measure across its full claimed reportable range — the Analytical Measuring Range (AMR). Skip this step, and you're out of compliance on day one.
This Excel template walks you through a complete AMR (reportable range) verification per CLSI EP06, using linearity materials or dilution series you already have on hand. No EP Evaluator subscription required.
What's included:
Dual acceptance evaluation: linearity (slope, R², auto-calculated) and percent recovery at each level
AMR span coverage check — confirms your test materials actually reach the upper and lower AMR limits claimed by the manufacturer
Up to 8 concentration levels with triplicate entry
Configurable acceptance limits sourced from the manufacturer package insert
Auto Pass/Fail at every level and for the overall study
Full compliance statement and lab director attestation section
Detailed instructions referencing CLIA §493.1253, CAP GEN.41056, and COLA Principle 7
Designed for FDA-cleared, non-waived, moderate complexity quantitative assays. Suitable for initial instrument verification and periodic re-verification.