Real-world compliance.
Clear steps. Documented follow-through.
Our CLIA compliance consulting approach connects regulatory requirements to daily testing, qualified personnel, and defensible records. Every engagement is scoped to your laboratory’s test menu, complexity, accreditor, operational risks, and the deadlines that actually matter.
Six stages from question to closure.
No oversized reports that sit untouched. We work toward clear findings, accountable owners, defensible evidence, and a practical path forward.
Understand the laboratory
Establish your CLIA certificate and testing complexity, specialties, accreditor requirements, laboratory director oversight, test menu, platforms, staffing model, and operational constraints.
- Intake discussion and applicable scope
- Instrument, assay, and testing inventory
- Current deadlines and inspection history
Review evidence, not assumptions
Examine a risk-based sample of records and observe workflows where appropriate. Compare written procedures against actual practices and requirements applicable to each service.
- QC and exception handling; PT and follow-up
- Personnel qualifications, training and competency
- Procedures, IQCP, corrective actions and validations
Prioritize what matters
Translate observations into a focused action register. Escalate issues with potential patient-testing implications to qualified laboratory leadership and distinguish immediate risks from planned improvement work.
- Risk-ranked gaps and potential deficiencies
- Clearly assigned owners and due dates
- Supporting evidence and decision points
Build and implement the solution
Work alongside your team on the actual corrective or project deliverables rather than simply handing over recommendations.
- Usable SOPs, forms and quality workflows
- Validation/verification study plans and summaries
- Mock inspection preparation and plans of correction
Confirm and document closure
Support the laboratory's review of completed actions and help assemble evidence showing what changed and whether the correction is working.
- Action-by-action follow-up
- Supporting records and approval packages
- Effectiveness checks and unresolved items
Keep readiness in motion
Where ongoing oversight makes sense, establish a practical cadence to revisit quality trends, personnel deadlines, procedure changes, and open actions.
- Monthly, quarterly, or targeted reviews
- Recurring responsibilities and escalation paths
- Review summary and action register updates
Useful deliverables. Visible accountability.
Specific outputs vary with scope, lab type, and applicable requirements. These are examples of the practical work we can help you produce.
Designed around the work your team needs done.
There is no single template for a waived physician office lab, a high-complexity reference laboratory, and a manufacturer launching a new platform.
Readiness, quality and oversight
CLIA/CAP/COLA alignment, quality-system review, mock surveys, competency programs, QC/PT processes, IQCP support, and corrective-action follow-through.
Explore our laboratory mock inspections and CLIA survey readiness support →
Method validation & verification
Define study scope and acceptance criteria for applicable performance characteristics; support data review, documentation, approval and operational handoff.
Implementation & FAS support
Assist with field implementation workloads, customer education, technical onboarding, study coordination, and structured instrument or assay rollout projects.
We support the laboratory's leaders. We do not replace them.
Final clinical, technical, and regulatory decisions remain with the laboratory director and other authorized personnel. The aim is to make their decisions better informed and their required records easier to maintain.
Discuss your laboratory's next step ↗