Quality Management Software for Clinical Laborator | Kintavo
CLINICAL OPERATIONS & CARE DELIVERY

Clinical Laboratories

CLIA, CAP, and ISO 15189 quality programs purpose-built for clinical, anatomic path, and molecular laboratories.

CLIA CAP ISO 15189
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THE PROBLEM

The Lab Runs on Heroics: One Coordinator, Forty Spreadsheets, and a CAP Checklist.

Clinical labs carry the densest inspection burden in healthcare — CAP checklists, CLIA surveys, and often ISO 15189 — on quality infrastructure built from spreadsheets and paper logs maintained by one heroic quality coordinator. QC review happens in batches. Competency slides. Reagent lots change hands without a record.

Every two years, the inspection sprint: weeks of reconciliation to make the paper agree with reality. The finding rate tracks the sprint, not the lab.

REGULATORY REQUIREMENTS

What CLIA, CAP, and ISO 15189 Require From Laboratory Quality

CLIA 493 requires control procedures that detect immediate error, documented competency on the six elements, and a director responsible for it all. CAP checklists demand evidence at line-item level: reagent lot qualification, maintenance at frequency, QC review with corrective action. ISO 15189 adds the management system: risk-based QC planning, document control, and continual improvement with records.

Kintavo runs the set as one system: rules at QC entry, competency cycles that schedule themselves, lots that quarantine until qualified — and the checklist evidence is the daily work, not a reconstruction.

WHAT AUDITORS LOOK FOR
QC failures with patient results released before corrective action.
Competency assessments missing elements or past the semiannual first-year cycle.
Expired or unqualified reagents accessible at the bench.
Maintenance records signed in batches — the Friday-pen pattern inspectors know.
WHAT KINTAVO REPLACES
Paper QC logs per analyzer → Acceptance criteria evaluated at entry, holds on failure
A competency spreadsheet → Six-element assessments on the CLIA cycle, automatic
Reagent logs in a binder → Lot quarantine-to-release with full traceability
Maintenance checklists on clipboards → PM tasks signed at the instrument, escalated on miss
The biennial inspection sprint → Inspection-ready as the steady state
CORE CAPABILITIES

The Whole CAP Checklist, Running as Daily Work.

QC Analysis
QC plans with criteria evaluated at entry, failures classified, corrective records gating release — exception-based review.
Training & Competency
CLIA six-element assessments scheduled per person, with qualification gating on testing workflows.
Inventory & Supplies
Reagent lots quarantined until qualified, expiry enforced, every movement on an append-only ledger.
Equipment & Maintenance
Function checks, calibration, and PM on one instrument schedule — completed at the bench.
Document Control
Procedure manuals current, director-reviewed on schedule, obsolete versions locked out.
Configurable Dashboard
The director’s CLIA responsibility as a live view — overdue, expiring, failed, across every section.
WHAT IT LOOKS LIKE IN PRACTICE

CAP announces. The quality coordinator does not cancel her vacation. The inspector samples: a reagent lot (quarantine-to-release record, one click), a tech’s competency file (six elements, current cycle, ten seconds), Tuesday’s QC failure (corrective record with repeats and signed release). Three findings last cycle; zero this cycle. The difference is not effort — it is where the evidence lives.

EVIDENCE, NOT CLAIMS

Pick Any Checklist Item. The Evidence Is the Work Itself.

Lot qualification, QC corrective action, competency records, maintenance at frequency — each exists because the workflow created it, signed, at the moment it happened. CAP inspection prep becomes a walkthrough.

Kintavo transaction ledger rows showing timestamped inventory operations with before-and-after quantities, source, and reason
SHOWN WITH SAMPLE DATA. YOUR NUMBERS APPEAR THE DAY YOU CONNECT YOUR SYSTEM.

Configured for your rules from day one.

CHECKLISTS
CAP checklist mapping
Every requirement linked to the records that prove it — inspection prep becomes a report, not a project.
COMPETENCY
Six-element competency tracking
CLIA competency assessments scheduled, documented, and current for every testing person.
QC
QC plans with acceptance criteria
Acceptance criteria evaluated at entry, with failures flagged before results ship — with review trails built in.
“
"Kintavo has been very responsive to our needs, enabling us to develop and customize reagent and blood QC apps quickly, ultimately supporting top-notch quality care for our patients."
Avera Health Sioux Falls, SD
MOST USED BY CLINICAL LABS TEAMS
QC Analysis → Calibration Tracking → Training Management → Document Control → Audit Management →
QUESTIONS & ANSWERS

Clinical Laboratories FAQ

Does Kintavo cover CAP checklist requirements?
The daily workflows — QC, lot qualification, competency, maintenance — generate the line-item evidence CAP inspectors sample. Labs walk inspections through live records instead of reconciled binders.
Can Kintavo handle multiple lab sections and sites?
Yes — chemistry, hematology, micro, molecular, and AP under one system, with section-level views and a network rollup for the director.
Does Kintavo interface with our LIS?
Kintavo complements the LIS: the LIS runs orders and results; Kintavo runs the quality layer — QC, competency, inventory, documents — and integrates via API where the two meet.
Who uses Kintavo in clinical laboratories?
Laboratories at MD Anderson Cancer Center, Hoxworth Blood Center, Avera, and SCL Health run quality processes on the platform.

See Kintavo configured for clinical labs.

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