CLIA inspections are usually unannounced, and the equipment section is where well-run labs most often lose points. The testing is fine; the paperwork that proves the instruments were working is not where it should be. This checklist walks through what a surveyor typically asks to see for your equipment, in the order it tends to come up.
Use it as a self-audit before your next survey. Anything you can't produce in a few minutes is a likely finding.
1. A current equipment inventory
Start with one list of every instrument that touches patient testing: make, model, serial or asset number, location, and who services it. Surveyors use this list to pick instruments and then ask for their records, so an incomplete inventory makes everything after it harder.
- Every analyzer, centrifuge, pipette, thermometer, refrigerator, freezer, cryostat, microscope and incubator used for testing
- Serial or asset number that matches the label on the instrument
- Service vendor and date of the last and next service
2. Calibration and calibration verification
CLIA requires labs to perform and document calibration and calibration verification according to the manufacturer's instructions, and calibration verification at least every six months for applicable test systems (42 CFR 493.1255). For support equipment, the surveyor wants to see that pipettes, thermometers, centrifuges and timers are checked on a defined schedule.
- Calibration certificates with as-found and as-left results
- Traceability to NIST or another recognized standard
- A dated label on each instrument that matches the certificate
- Calibration verification records for test systems, at least every six months
3. Maintenance and function checks
CLIA requires maintenance and function checks as defined by the manufacturer, documented (42 CFR 493.1254). This is the daily, weekly and periodic work your staff does, plus preventive maintenance by your service vendor.
- Daily and weekly maintenance logs, initialed and dated
- Preventive maintenance reports from your service vendor
- Repair records, including what failed and how it was verified afterward
- Manufacturer's maintenance requirements available for reference
4. Temperature records
Thin temperature records are one of the most common equipment findings. Every refrigerator, freezer, incubator, water bath and room where temperature matters needs a log with an acceptable range and a record of what was done when a reading fell outside it.
- Daily temperature logs with the acceptable range printed on the log
- Calibrated thermometers or data loggers, with their own certificates
- Documented corrective action for every out-of-range reading
5. Electrical safety
Electrical safety is not a CLIA test-system rule, but facility surveys and accrediting bodies such as CAP and The Joint Commission look for it, and AHCA surveys look for it in many Florida facilities. Keep current NFPA 99 test results for patient-care and laboratory equipment.
6. Corrective action and records retention
Surveyors look past the passing results to what happened when something failed. Each failed check should lead to a documented action and a documented re-check. CLIA generally requires labs to keep these records for at least two years (42 CFR 493.1105), and some records longer.
The quick self-audit
Pick five instruments at random from your inventory. For each one, try to produce the last calibration certificate, the last preventive maintenance report and the last month of logs within five minutes. If any of the fifteen documents takes longer, start there.
Want a second set of eyes? Our free equipment readiness checklist covers the same ground, and our inspection readiness service will walk your lab with you. For more detail on what assessors check instrument by instrument, read what CLIA and CAP surveyors actually check on your equipment.