The practical quality system for CLIA certification, COLA, and TJC labs
Document control, competency, proficiency testing, and corrective action in one system your whole lab uses — so you're ready for your next CLIA inspection or COLA/TJC survey, every day, not the week before.
What does CLIA certification require a lab to keep up?
CLIA certification requires a clinical lab to maintain controlled procedures, documented personnel competency, successful proficiency testing, quality control, and corrective action — and to produce all of it on inspection. LabMODO is the practical quality system that holds those live: current procedures, competency tracked per person, PT scheduled and recorded, and corrective actions closed. It runs the quality side around your LIS, so an inspection is a walkthrough, not a scramble.
A CLIA inspection or COLA survey finds what your spreadsheets lost
Clinical labs carry the same quality load as any regulated lab — procedures, competency, PT, QC, corrective action — and most carry it in binders, shared drives, and one person’s memory.
- Competency is the first thing they check, and the hardest to prove. CLIA expects documented, ongoing competency assessment for every person doing testing — and tracking it by hand is exactly where labs get cited.
- Procedures drift. Out-of-date procedure copies at the bench, no record of who read the current version — the uncontrolled-document finding, in a clinical setting.
- It all surfaces under inspection. Whether it’s COLA accreditation, a TJC survey, or a CLIA inspection, the evidence is reconstructed under time pressure instead of produced on demand.
How LabMODO covers what CLIA, COLA, and TJC inspectors check
Not the whole product tour — the quality requirements an inspector actually walks through, each with a home in LabMODO:
01
Controlled procedures.
Every procedure approved before it’s live, current at the bench, every revision tracked — so there’s one current version and a record of who’s trained on it. → SOP & document management
02
Documented competency.
Competency tracked per person and per test, with initial and ongoing assessment on a cadence — the requirement CLIA inspections lean on hardest. → Competency tracking
03
Proficiency testing.
Every PT event scheduled, results recorded, and a failure driven to a corrective action — not an email nobody owns. → Proficiency testing
04
Corrective action.
Nonconformities and corrective actions caught, closed, and provable — the quality-management backbone CLIA, COLA, and TJC all expect. → CAPA & nonconformance
05
Runs around your LIS.
LabMODO isn’t a clinical LIS and never replaces one — your LIS runs patient samples and results; LabMODO runs the quality system around it. Where the LIS stops, LabMODO starts. → Works with or without your LIS
One system, watched from above
LabMODO runs the quality side of a clinical lab as one loop — rules → able people → daily work → checked against your standards — with Mission Control as the lid: lab status Green/Yellow/Red, competency coverage, and everything past due or upcoming. When an inspection or a failed PT finds something, the finding updates the rules and the loop closes. Readiness for your next CLIA certification inspection becomes a status you can see, not a season you dread.
What a CLIA, COLA, or TJC lab gets from a quality system it actually uses
Competency you can produce in seconds.
Every person, every test, current and documented — the first thing an inspector asks, answered on screen.
No uncontrolled procedures.
One current version at the bench, a record of who’s trained on it — the document finding disappears.
Ready for every framework at once.
CLIA, COLA accreditation, TJC, or ISO 15189 certification — the same evidence satisfies the quality requirements across all of them.
The inspection is a walkthrough.
Evidence current the day the work happens turns the survey into a tour, not a two-week reconstruction.
Twenty minutes about your lab — and what to fix first
Bring your competency records, procedures, and PT schedule however they live today. We'll look at what a CLIA inspector or COLA/TJC surveyor would struggle to find, and what it takes to produce it on demand. You get a plan either way.
FAQ
Questions labs actually ask
If yours isn’t here, ask it on the demo.
Does LabMODO provide or issue CLIA certification?
Does LabMODO provide or issue CLIA certification?
No — CLIA certification is issued by CMS, and COLA and TJC accredit labs; no software can grant or be any of them. LabMODO is the quality system that keeps you ready for the inspection: current procedures, documented competency, PT, and corrective action, all producible on demand.
Does it handle CLIA competency assessment?
Does it handle CLIA competency assessment?
LabMODO tracks competency per person and per test, with initial and ongoing assessment on a cadence, and flags it before it lapses. [Mike: confirm this maps to CLIA’s specific competency-assessment requirements before publish.]
Does it work for COLA accreditation and TJC surveys too?
Does it work for COLA accreditation and TJC surveys too?
Yes — the quality evidence a COLA accreditation assessor or TJC surveyor checks (documents, competency, PT, corrective action) is the same evidence LabMODO holds, so one system covers all three frameworks. The same applies to ISO 15189 certification for medical labs.
Is LabMODO a clinical LIS?
Is LabMODO a clinical LIS?
No — LabMODO isn’t a LIS and doesn’t replace one. Your LIS runs patient samples and results; LabMODO runs the quality system around it. It works with your LIS or without one.
How fast can we be running?
How fast can we be running?
Most teams are running in about four weeks. LabMODO moves your procedures, competency records, and schedule in first, then your team learns it in four one-hour calls, with a certified auditor reviewing your quality content along the way.