CAP and CLIA evidence at every accessioning step.
Clinical and diagnostic labs run accredited, high-volume analyzer fleets under CAP, CLIA, and ISO 15189 — with assay-specific calibration, daily QC, and proficiency-testing posture that has to survive a CAP inspection. Wēlr is the equipment-side record that proves every result was produced by a qualified instrument operating in a controlled state.
Four findings the inspector will write up.
- 01
Daily QC and proficiency testing are reconciled by hand.
Levey-Jennings runs, Westgard violations, and PT material results sit in the LIS. Calibration, preventive maintenance, and service events sit in the CMMS. The link between an out-of-control run and the maintenance event that preceded it is rebuilt during root cause.
- 02
Method validation drifts from the analyzer it lives on.
CLSI-aligned validation packages (EP05, EP09, EP15, EP17) are written once and filed. The analyzer they qualify lives in another system. Revalidation triggers — firmware change, reagent lot change, location move — aren't tied to the equipment record.
- 03
Inspection prep is a four-week reconciliation.
CAP, CLIA, and ISO 15189 surveys want the same underlying evidence presented differently. The lab produces three packets, not one queryable record.
- 04
Equipment qualification is calendar-based, not state-based.
IQ/OQ on install, annual PMs, and that's it. Daily-use evidence — temperature monitoring, cycle counts, drift signals — isn't fed back into the qualification posture.
Four primitives. One accredited record.
Analyzer-level lifecycle record
IQ/OQ at install, calibration certificates, daily QC, PT events, method-validation packages, and service work orders share one append-only record per analyzer. CAP inspection prep becomes a query, not a project.
QC and service on one timeline
Westgard violations surface next to the calibration, reagent-lot change, or service event that preceded them. Root-cause review reads top-to-bottom on one screen instead of switching between LIS and CMMS.
State-aware revalidation
Revalidation triggers are computed from the equipment record — firmware change, reagent lot, location move, major service event. The system tells the lab when revalidation is due; it isn't tracked on a calendar.
One evidence model, three accreditation postures
CAP All Common Checklist, CLIA 42 CFR 493, and ISO 15189:2022 export builders draw from the same data. The lab produces the data once and presents it three ways.
Why not just stitch LIS, CMMS, and a paper QC binder?
Most labs run LIS for results, CMMS for service, and a binder for QC. Three systems. Three audit trails. One inspector.
| Capability | Wēlr | LIS only Beaker · Epic · Cerner | CMMS only Maximo · MicroMain | Paper QC binder |
|---|---|---|---|---|
| Westgard violation linked to maintenance event | One timeline, automatically | Result-side only | Service-side only | Reconstructed by hand |
| Reagent-lot change as revalidation trigger | System-driven | Lot tracked, no equipment link | Equipment tracked, no lot link | Memorized |
| CAP-ready inspection packet | Query, on demand | Manual export, 2-3 weeks | Manual export, 2-3 weeks | Multi-week reconciliation |
| Analyzer IQ/OQ + daily QC + PT on one record | Single append-only record | QC + PT only | IQ/OQ + service only | Three binders |
| Method-validation revalidation trigger | Firmware / lot / location / service | Manual | Manual | Calendar |
Westgard violation, alongside the service event that caused it.
When a CAP inspector asks why your Glucose channel went out of control on March 14th, you don't switch between systems. The QC run, the service event, the reagent-lot change, and the auto-hold all live on one timeline. The root-cause investigation is half-done before you open the ticket.
- QC runs (Levey-Jennings, Westgard 1-3s / 2-2s / R-4s)
- Service events, calibration cert refreshes, reagent-lot changes
- Auto-hold on Westgard violation · runs paused until release
- Append-only audit trail · SHA-anchored · CAP-ready export
- 09:12QCL1 within ±2 SD · Glucose · Lot RG-2841
- 09:14QCL2 within ±2 SD · Glucose · Lot RG-2841
- 11:48SERVICEFSE on-site · cuvette ring replaced · WO-1184
- 11:52CONFIGReagent lot change · RG-2841 → RG-2906
- 12:07QCL2 outside +3 SD · Westgard 1-3s violation
- 12:09ALERTAuto-hold on Glucose channel · runs paused
- 12:31ROOTRun linked to WO-1184 + lot change · investigation opened
If any of these are true, we should talk.
- ✓Your last CAP or CLIA inspection took longer than two weeks to prepare.
- ✓Your QC team and your biomed/service team use different systems and the link between a Westgard violation and the maintenance event that preceded it is reconstructed by hand.
- ✓Your method-validation packages live in a document-management system that doesn't know which analyzer they qualify.
- ✓Reagent lot changes do not automatically flag instruments for revalidation.
- ✓You run more than one site under more than one accreditation framework (CAP + ISO 15189, CAP + CLIA + JCI) and produce the same evidence multiple times.
A small founding cohort is shaping Wēlr for clinical & diagnostic labs.
Founding partners get preferential pricing, a direct line to engineering, and meaningful influence over the Healthcare roadmap. Limited to a small cohort per vertical.
- Preferential pricing
- Direct line to engineering
- Roadmap influence
- Limited cohort
Ready to stop stitching service evidence together?
If your team is juggling PDFs, support packages, work orders, customer updates, and QA evidence across five systems, Wēlr is worth a look.
Welr LLC · Delaware