Provide general consultation on state and federal (CLIA) requirements for licensing, certifying, and operating a clinical laboratory.

Provide general consultation on Good Clinical Laboratory Practices (GCLP)

Assist in state and CLIA application submission.

Develop draft preanalytic, postanalytic, and general written procedures as requested.

Develop a comprehensive Quality Assurance and Assessment program

Review documents including Standard Operating Procedures, personnel, and validation documents as requested.

Conduct onsite audit to assess overall readiness for upcoming state, CLIA, and/or Accrediting inspections.

Conduct onsite GCLP audits.

Upon request, prepare written audit report setting forth opinion(s) and the basis for opinion(s) regarding laboratory compliance with applicable laws and federal CLIA regulations.