Our consulting services
We provide expert guidance to clinical diagnostic laboratories to ensure compliance with industry standards and regulatory requirements, reducing risks and streamlining operations.
- Regulatory & Compliance Consulting
- CLIA Certification & State Licensing (e.g., CDPH)
- Lab Accreditation Support (e.g., CAP).
- Personnel Credentialing (ASCP, CDPH – Generalist and Specialist CLS licensing)
- Policy & SOP Development Aligned with Regulatory Standards
- Audit Preparation & Corrective Action Planning
- Quality Assurance & Proficiency Testing
- Quality Management System (QMS) Setup & Oversight
- Internal Quality Audits & Gap Analysis
- Proficiency Testing (PT) Program Setup & Interpretation
- Root Cause Analysis & CAPA Program Development
- Continuous Quality Improvement (CQI) Initiatives
- Laboratory Operations & Management
- Workflow Optimization
- Laboratory Director & Technical Consultant Roles/Referrals
- Staff Training & Competency Assessments
- Reference Lab Workflow and Referral
- Vendor & Instrument Validation & Verification (IQ/OQ/PQ)
- Test Menu Feasibility & Expansion
- Safety & Risk Management
- Biosafety Program Design (BSL-2/BSL-3)
- Hazardous Waste & OSHA Compliance Plans
- Exposure Control & Emergency Preparedness Training
- Safety Audits & Risk Mitigation
- Facility & Laboratory Design
- Laboratory Planning & Layout Consulting
- Workflow-driven Facility Design & Expansion Support
- Ergonomic & Environmental Assessments
- Inspections & Audits
- Mock- and Pre- Inspections & Readiness Assessments
- Post-inspection CAPA Implementation
- Independent Quality & Compliance Audits
- Operational Efficiency Reviews
- Training & Education
- CLIA, CAP Compliance Training
- Quality Control & Best Practice Workshops
