Accuracy & Precision Verification Toolkit – CLSI EP15 + EP09 Includes SOP Template for New Method Verification

Test Method Verification Toolkit – CLSI EP15 & EP09

(Includes Precision, Accuracy, and SOP Templates)

The Test Method Verification Toolkit is designed for small laboratories and physician office laboratories (POLs) that implement or modify FDA-cleared, non-waived tests and need clear, inspection-ready documentation—without the cost or complexity of enterprise statistical software or recurring subscriptions.

This toolkit supports test method verification, using terminology and study approaches consistent with CLSI and CLIA expectations and appropriate for FDA-cleared test systems. It brings together the core components required for verification into a single, cohesive package, providing structured templates, automated calculations, and standardized language aligned with CLSI guidance and CLIA, CAP, and COLA inspection expectations.

Designed for laboratories that perform verification periodically rather than continuously, this toolkit enables verification at the appropriate level of rigor—without over-engineering or unnecessary expense.

What’s Included

✔ Precision Verification Template – CLSI EP15 (Excel)

Supports user verification of precision for FDA-cleared quantitative tests using a multi-day, multi-run study design consistent with CLSI EP15. Includes automated calculations for mean, standard deviation (SD), coefficient of variation (CV%), and objective PASS / FAIL determination based on manufacturer precision claims.

✔ Method Comparison Template – CLSI EP09 (Excel)

Provides a structured framework for patient-sample method comparison between a new test system and an existing or reference method, consistent with CLSI EP09 principles. Supports estimation of bias and assessment of agreement as part of test method verification.

✔ General-Purpose SOP Template (Word)

Includes a customizable SOP template designed to document the laboratory’s general approach to verification and related activities. The SOP is intentionally flexible and may be adapted for waived and non-waived testing, as well as non-analytical laboratory procedures, and aligns with CLIA documentation expectations applicable to CAP and COLA inspections.

Why This Toolkit Makes Sense for Small Labs and POLs

Many small laboratories and POLs perform test method verification infrequently and do not need to maintain annual licenses for statistical or validation software just to complete occasional studies.

This toolkit is built for laboratories that need:

• CLSI-aligned verification documentation

• Clear study structure without unnecessary complexity

• Inspection-ready records

• A practical alternative to recurring software costs

It delivers the right level of rigor without unnecessary overhead.

Intended Use

This toolkit is intended to assist clinical laboratories with internal documentation and evaluation of test method verification studies for moderate- and high-complexity testing, when verification is appropriate for FDA-cleared test systems and within the laboratory’s scope of practice.

This toolkit supports test method verification (sometimes informally referred to as “validation”) and is not intended for full validation of laboratory-developed tests (LDTs).

Compatibility

• Microsoft Excel (desktop version recommended)

• Microsoft Word

• Not designed for Google Sheets, Excel Online, or Google Docs

License

• Single-laboratory use

• Redistribution, resale, or sharing outside the licensed laboratory is prohibited

Disclaimer

This toolkit is provided as an educational and documentation support resource and does not replace professional judgment or regulatory requirements. Laboratories remain responsible for ensuring compliance with CLIA, CLSI, CAP, TJC, COLA, and applicable state regulations, and for determining the appropriateness of verification activities for their specific test systems.