CLIA Compliance Software for Medical Practice Labs

If your practice performs any laboratory testing on human specimens — even simple waived tests like rapid strep, glucose monitoring, or urine dipsticks — you need a CLIA certificate. The only exception is tests cleared by the FDA for home use.

Waived tests are simple procedures with low risk of error (rapid tests, dipsticks). Non-waived tests require more complex procedures and are subject to more stringent CLIA requirements including proficiency testing, quality control, and personnel standards.

The certificate type depends on your testing complexity. A Certificate of Waiver covers only FDA-waived tests. A Certificate of Provider Performed Microscopy (PPM) adds microscopy procedures. Higher complexity testing requires a Certificate of Registration or Accreditation. GuardWell helps you determine and track the right certificate type.

GuardWell tracks your CLIA certificate (type, number, effective dates, and renewal deadline) and auto-assigns lab staff training so you can demonstrate competency. Other CLIA operational requirements — QC logs, proficiency testing, lab director designation — are surfaced as compliance checklist items you can mark off manually as your program matures.

CLIA survey inspections typically occur every two years for non-waived laboratories. Certificate of Waiver holders may be subject to random inspections. GuardWell tracks certificate status and staff training completion so those elements stay current; the broader compliance checklist helps you see what still needs attention before a survey.