Clinical Lab AI drafts SOPs, tracks proficiency testing, keeps competency records current, and validates assay performance against CLIA §493, CAP, and ISO 15189. Built for single-site independent labs, hospital reference networks, and multi-national operators from day one.
What it does
Clinical Lab AI focuses on the operational surfaces where lab directors, QA officers, and testing personnel lose the most time to paperwork. Not a QMS — Clinical Lab AI produces the records that fill your QMS.
01 · Method validation
Accuracy, precision, reportable range, reference interval, analytical specificity, sensitivity, interfering substances. AI-drafted study protocols, structured data capture, printable reports for your Technical Consultant to sign.
Per assay · §493.1253 · CAP GEN.42020 · ISO 15189 §5.5
02 · Proficiency Testing
Quarterly enrollment tracking with per-analyte coverage attestation, result entry with automatic scoring, and a corrective-action workflow that satisfies CMS surveyor expectations for unsuccessful PT — the finding that triggers 60% of Condition-level deficiencies.
Per lab · §493.801-§493.865 · CAP checklists
03 · Competency Assessment
Direct observation, monitoring results, QC review, maintenance observation, blind rechecks, problem-solving. Persistent per-person records with automatic due-date rollup on the Compliance Calendar so nothing lapses silently.
Per testing person · §493.1235 · §493.1451(b)(8)-(9)
Regulatory coverage
Labs pursuing dual accreditation (CLIA + CAP), international recognition (ISO 15189 · UKAS), or cross-jurisdictional operations get one document set with framework overlays — not four separate binders that drift out of sync.
US federal certification via CMS. Waived · PPM · Moderate · High complexity paths, each with its own personnel + QC + PT expectations.
42 CFR §493
College of American Pathologists accreditation. All-Common + discipline-specific checklists (Chemistry · Hematology · Microbiology · Molecular · AP).
15,000+ checklist items
International quality standard for medical laboratories. Recognized by UKAS, ANAB, and equivalent European accreditation bodies.
ISO 15189:2022
Laboratory-Developed Tests under the 2024 final rule. Shared 510(k) infrastructure with Med Journey AI for LDTs that need FDA clearance.
21 CFR 809 · 21 CFR 820
Multi-lab · Multi-national
Quest. Labcorp. SYNLAB. Eurofins. Sonic. Unilabs. Recursive Enterprise hierarchy so a corporate QA director can roll up performance across every subsidiary, and drill into a single Cert-of-Compliance lab in one click.
The reporting question multi-lab QA directors actually ask — are all my labs running the same test the same way? — today lives in spreadsheets stitched together quarterly. Clinical Lab AI turns it into a live view: same-assay drift detection, SOP-version harmonization across sites, reference-interval consistency, cross-lab PT benchmarking.
Data-residency-aware from day one for EU + UK operators. Multi-language SOPs. Framework overlay per lab so a Munich site runs under ISO 15189 while a Miami site runs under CLIA + CAP — both under the same corporate tenant.
Partnership
Every Bollong.AI regulated-vertical product is co-built with a domain SME who owns the depth we can't fake. Revenue is shared under the cohort tier structure. The right partner is someone with credentials that read as authority to a CMS surveyor — and access to the artifacts the AI needs to learn from.
The engineering, infrastructure, distribution, and go-to-market are ours. The domain — the surveyor's mental model, the pattern recognition of what a Condition-level deficiency looks like, the judgment on when a Technical Consultant needs to intervene — is yours.
Waitlist
The first six labs get a dedicated build partner from the Bollong.AI team, free access through the beta, and lifetime discount on Enterprise pricing. Reserve your slot below.