# CLIA-aligned validation / verification outline

Status: DRAFT. Human review required. Decision support only. Local CLIA certification, state law, and medical director judgment control.

- Laboratory:
- Test name / code:
- Method:
- Owning department / lab code:
- Intended use:
- Specimen types:
- FDA-authorized, modified, or LDT:

## Performance characteristics

- Accuracy / method comparison
- Precision (repeatability and reproducibility)
- Analytic sensitivity (LoD)
- Analytic specificity / cross-reactivity
- Reportable range (if quantitative)
- Reference interval or interpretive criteria
- Specimen-type equivalence
- Interfering substances

## Result values (coded first)

- Observation LOINC:
- Allowable results + SNOMED CT:
- Quantitative units (UCUM) if any:

## Quality control and proficiency testing

- Controls per run / per day:
- PT provider and analytes:
- Lot-to-lot checks:

## Reflex, referral, reporting

- Reflex algorithm:
- Public-health notification:
- ELR mapping (OBR-4, OBX-3, OBX-5):

## Human gates

- Medical director (or designee) signature:
- Quality manager filing / SOP version:
- Effective date (not assigned by any agent):

## Attachments

- Raw data tables
- Package insert or LDT design record
- Primary sources (CMS, CDC, APHL, manufacturer)