CAP & CLIA Advisory Services

Our work focuses on clarity, sequencing, and operational discipline — helping teams avoid reactive fixes and reduce regulatory risk before inspection pressure sets in.

We support early laboratory design and operational decision-making to ensure systems scale cleanly and support inspection readiness.

• Laboratory setup and facility design review
   
• Workflow and operational process alignment
   
• Test menu development and expansion planning
   
• Personnel planning and operational staffing considerations
   
• Efficiency, cost, and productivity improvement initiatives

We help teams prepare for CAP and CLIA expectations with a focus on understanding, ownership, and execution — not just documentation.

• CLIA application preparation and submission support
   
• Inspection readiness assessments and preparation
   
• CAP and CLIA checklist interpretation and gap analysis
   
• Laboratory self-audits and risk identification
   
• Analytical testing compliance support under CLIA

We work with laboratories to design and strengthen quality systems that support both compliance and day-to-day operations.

• Development and implementation of CLIA-compliant quality systems
   
• Quality assurance program design and optimization
   
• Review and remediation of existing quality infrastructure
   
• Ongoing compliance advisory support

We work with laboratories to design and strengthen quality systems that support both compliance and day-to-day operations.

• Development and implementation of CLIA-compliant quality systems
   
• Quality assurance program design and optimization
   
• Review and remediation of existing quality infrastructure
   
• Ongoing compliance advisory support

We help teams build documentation and training programs that reflect how work is actually performed and hold up under inspection.

• SOP development and documentation review
   
• Staff training and competency program design
   
• Operational documentation to support inspections and audits