Lab-Based Testing
CLIA (42 CFR Part 493)29 CFR 1910.1020
Point-of-care laboratory testing performed under a CLIA Certificate of Waiver, with send-out to reference laboratories where a result needs confirmation. Waived status attaches to the specific test system as cleared by the FDA — not to the analyte, and not to the operator — which is a distinction that decides whether a program is compliant or not.
What it costs
Lab-Based Testing
Point-of-care kit costs vary widely by analyte, so this is an average across a typical menu. Per-panel pricing is set once your approved test menu is fixed.
Prices are indicative per-test rates for a scheduled event at a mobilized site. Final rates are set with your scope — headcount, test mix, travel, and event frequency all move the number. Your scoped quote is free.
What it is
What the service actually covers.
- CLIA-waived point-of-care panels run on site, with results in the same encounter.
- Send-out to reference laboratory testing where a waived result requires confirmation, or where the clinical question exceeds what a waived test can answer.
- Results integrated directly into the Occupational Health Record alongside the rest of the employee's surveillance history.
- Notifiable condition reporting to the state health department where required, independent of the employer relationship.
- Full retention of results, QC logs, temperature logs, and lot documentation as employee medical records.
How we run it
The standards we hold, including where they exceed the rule.
- Manufacturer instructions are the protocol. For every waived test, the package insert is the controlling document. Staff do not modify specimen type, volume, timing, or storage.
- Waived status is conditional. A waived test performed outside the manufacturer's instructions — modified specimen type, altered timing, off-label sample handling — becomes high-complexity testing and takes the site out of CLIA compliance entirely.
- The test menu is controlled. Only tests on the site's approved menu are performed. Adding a test requires verification of its FDA-waived status and a documented competency sign-off before first patient use.
- Waived results are screening results. Any result driving a fitness-for-duty, work-restriction, or disqualification decision routes to the supervising physician before it influences employment status.
- You receive fitness and restriction determinations, not raw clinical values.
- Certificate renewal runs on a two-year cycle and is tracked as a standing compliance obligation, not an ad hoc task.
At your site
What standing this up on a new site takes.
Sorted out during site survey, before anything is scheduled.
- A CLIA Certificate of Waiver confirmed before the first billable test. For a mobile or multi-site operation this means confirming with the CMS state agency whether one certificate covers all trailers and client sites, or whether separate certificates are required by location.
- State clinical laboratory registration and any local licensure verified for the operating state before deployment — CLIA is the floor, not the whole obligation.
- An approved test menu agreed up front. The menu drives kit inventory, storage requirements, and per-panel cost, so fixing it early is what makes pricing firm.
- Temperature-controlled storage in the trailer or clinic space for kits with cold-chain requirements.
Results live in the Occupational Health Record, separate from the personnel file. Supervisors receive fitness-for-duty and restriction information only — never underlying results or diagnoses. Employee medical records are retained for the duration of employment plus 30 years, per 29 CFR 1910.1020.
More services
Most sites bundle these into one event.
Setup and travel are already absorbed once we are on site, so stacking service lines into a single visit is materially cheaper per employee than scheduling them separately.
A licensed paramedic on screen the moment your crew needs one, guiding care hands-on through your certified team.
Non-DOT urine and oral fluid collection, run to DOT-equivalent protocol.
Qualitative and quantitative fit testing under the OSHA respiratory protection standard.
Baseline and annual audiograms for hearing conservation programs, run in a mobile setting.
Occupational spirometry to ATS/ERS standards, with NIOSH-trained operators.
DOT vision certification support and employer-defined non-DOT acuity screening.
Get covered
Ready to get lab-based testing running at your site?
Send us your headcount, your location, and which service lines you need. We will come back with a real rate card for your scope and what it takes to stand it up. No obligation.