Stay licensed, stay accredited, stay inspection-ready
Compliance isn't paperwork — it's what keeps your lab open. Zilgene handles the licensing, accreditation, and quality-documentation work that keeps laboratories in good standing: new applications, renewals, mock inspections, and corrective action when findings come back.
Who it's for
- New labs applying for CLIA certification and state licenses
- Labs pursuing or maintaining CAP or COLA accreditation
- Labs that received inspection deficiencies and need a corrective action plan
- Labs without a full-time lab director or quality lead that need interim expertise
Services in this area
- CLIA license applications and changes
- CAP and COLA accreditation applications and changes
- State-specific license applications (California, New York, Florida, and others)
- Interim lab director, clinical consultant, and technical consultant services
- Evaluation of laboratory director, clinical/technical consultant, and laboratory personnel qualifications
- Mock inspections, inspection readiness, and gap analysis
- Responses to audit and inspection deficiencies and corrective action plans
- Standard laboratory SOPs
- QC records evaluation
- Individualized Quality Control Plans (IQCP)
- QA plans
- Requisition forms and CMS-compliant patient reports
- General guidance for CPT coding
- Proficiency testing enrollment and alternative assessment plans for analytes with no PT available
- LIS and EMR integration support
How an engagement runs
- Current-state review. We look at where you stand: licenses held, accreditations, past inspection reports, personnel files, and quality records. This becomes the baseline everything else builds on.
- Gap analysis. We compare your current state against what CLIA, your state, and your accreditor require — and rank every gap by risk, so the most dangerous issues get fixed first.
- Corrective action plan. Each gap gets a specific fix, an owner, and a deadline. Nothing vague, nothing left as "we'll get to it."
- Documentation build. We write or rewrite what regulators ask for: SOPs, IQCPs, the QA plan, requisition forms, and patient report templates that meet CMS requirements. Personnel qualifications are evaluated and documented against the regulations.
- Proficiency testing and QC setup. We make sure you're enrolled in the right PT programs — with alternative assessment plans for analytes where no PT exists — and review your QC records so they hold up under scrutiny.
- Mock inspection. Before the real one, we inspect you the way an inspector would: document review, personnel interviews, records trace. Findings come back as a prioritized punch list.
- Deficiency response. If findings arrive anyway, we draft the responses and corrective action plans, including evidence of correction — the part that determines whether a deficiency stays open.
What you get
- A ranked gap analysis with a corrective action plan
- Filed license and accreditation applications (CLIA, state, CAP, COLA)
- Written SOPs, IQCPs, and QA plans
- CMS-compliant requisition and report templates
- Personnel qualification evaluations
- PT enrollment and alternative assessment documentation
- Mock inspection findings with a remediation punch list
- Deficiency responses with evidence of correction
FAQ
We've already failed an inspection. Can you help us respond? Yes — that's a common engagement. We review the deficiencies, build the corrective action plan, draft the responses with supporting evidence, and fix the underlying gaps so they don't repeat.
What's the difference between CLIA certification and CAP/COLA accreditation? CLIA certification is the federal baseline required to test human specimens. CAP and COLA accreditation are voluntary programs that meet (and in some cases exceed) CLIA requirements — many labs use them in place of a routine CMS survey. We help with both.
Can you serve as our interim lab director or consultant? Yes. We provide interim lab director, clinical consultant, and technical consultant services, and we evaluate whether your existing personnel meet the qualification requirements for their roles.
Do you help with LIS and EMR integration? Yes — we support LIS and EMR integration from the compliance side, making sure requisitions, reports, and records meet CMS requirements.
Start the conversation
Every engagement is scoped and quoted upfront — no open-ended hourly billing. The first consultation is free, and you'll know the exact cost before any work begins.