Ā» The On-Site Licensing Section provides oversight of in-state and out-of-state California-licensed clinical laboratories by conducting on-site inspections and monitoring proficiency testing performance. These laboratories include physician offices, clinics, hospitals, independent laboratories, and public health laboratories.
- There are approximately 2,500 licensed clinical laboratories located within California and approximately 520 out-of-state licensed clinical laboratories. Inspections are performed by LFS examiners and Department-approved accreditation organization inspection staff.
- In addition to initial and routine inspections, the section also conducts complaint inspections and investigations.
- The section also reviews and approves accrediting organizations (AOs) for the purpose of deeming laboratories to be in compliance with California and federal laws. Accrediting organizations approved by the Department conduct inspections on behalf of LFS. Oversight of approved AOs is conducted through validation inspections of laboratories and continuous evaluation of an AOās total inspection process.
- The section also oversees and coordinates enforcement actions of non-compliant laboratories and may issue principle, intermediate, or alternative sanctions to encourage compliance with California laws and requirements.ā