Overview
Job Description and Duties
Performs onsite inspections of clinical laboratories and physician office laboratories to determine compliance with California Business and Professions Code, Chapter 3 and Federal 42CFR Part 493 requirements for clinical laboratories and Clinical Laboratory Improvement Amendments of 1988 (CLIA) standards related to all aspects of pre-analytical, analytical, and post-analytical performance. Reviews Examiner I survey reports and makes recommendations regarding the issuance of laboratory licenses and approvals for accuracy, appropriateness, and clarity; consults with field surveyors regarding survey reports in order to determine whether the laboratory is in acceptable compliance with appropriate state and federal laws and regulations. Performs follow-up inspections as necessary to ensure correction of deficiencies. Conducts complaint investigations, as assigned, to determine possible violations of State and Federal law. Assists the Examiner III in the preparation of sanction referral packages for the Center for Medicare and Medicaid Services (CMS) CLIA program. Provides excellent customer service and expert technical assistance through all methods of communication responding to complainants, the regulated community, the legislature, the Governor’s office, the public, the media, and others. Responds to written and telephone inquiries regarding interpretation of laws, regulations, and policies (State and Federal) to the laboratory community and general public. Participates with legal counsel in preparation of possible court hearings related to laboratory sanctions for non-compliance and will testify at hearings on behalf of the CDPH.
About The California Department of Public Health
The California Department of Public Health (CDPH) works to protect the public's health in the Golden State and helps shape positive health outcomes for individuals, families and communities. The Department's programs and services, implemented in collaboration with local health departments and state, federal and private partners, touch the lives of every Californian and visitor to the state 24 hours a day, 7 days a week.
Our Shared Vision
CDPH public health professionals, researchers, scientists, doctors, nurses, and other staff members have a shared vision to protect and improve the health of all Californians. We are dedicated to public service and passionate about our work and the people and communities we serve and protect.
