# Survey / OIG-ready evidence checklist

Decision support only. Completing this list does not certify the laboratory.

## Personnel and integrity

- [ ] Current CLIA personnel files for high-complexity testing
- [ ] Competency assessments tied to the tests each person performs
- [ ] LEIE + SAM screening log with monthly close
- [ ] Contractor and vendor screening in the same log

## Methods

- [ ] Validation or verification packet for every live assay
- [ ] LDT design records where applicable (post-2025 LDT status: still CLIA)
- [ ] SOP version history with effective dates
- [ ] Proficiency testing enrollment and scored results
- [ ] QC review and corrective action files

## Reporting

- [ ] ELR companion mapping (LOINC / SNOMED) for reportable tests
- [ ] Written statement of what AI / agents may not do
- [ ] Audit trail export: accession, result, verify, transmit
- [ ] Destination acknowledgments (ACK) for recent ELR

## Preparedness

- [ ] Surge / continuity plan
- [ ] Biosafety and referral pathways for high-consequence assays
- [ ] Current state reportable list overlay

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