The Clinical Laboratories Unit is responsible for licensure of all laboratories that obtain specimens from Washington DC citizens for federal certification. The unit serves as the agent for federal certification in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Program, which is required for all clinical laboratory testing sites including those seeking Medicare reimbursement.
The unit is responsible for the licensure of laboratories performing Infectious Disease testing and Tissue Banks. Also, approvals for Health Screenings, Temporary Testing, and Out of State Testing.
Laboratory Unit Programs:
- Clinical Laboratories
- Hospital Laboratories
- Physician Office Laboratories
- Pharmacy Laboratories
- Independent Reference Laboratories
- Tissue Banks
- Communicable and Reportable Disease Testing
- Health Awareness Screenings
- Temporary Testing Sites
For inquiries concerning CLIA, regulations, and other laboratory concerns, including complaints, please contact DC Health at [email protected].
DCHEALTH LINKS:
dchealth.dc.gov
Tissue Bank
DCRegs
Complaint form
If you are applying for CLIA certification: Submit application to DC Health, Health Regulation and Licensing Administration, Health Care Facilities Division, 899 North Capitol Street NE, 2nd FL, Washington, DC 20002 with a copy of the director's DC medical license, PhD, or highest degree earned. Include board certification for moderate and high complexity laboratory applications.
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA
Changes to CLIA certification must be submitted to our office, DC Health on a CMS CLIA application. Please include a copy of the lab director's DC medical license or highest degree earned: https://www.cms.gov/files/document/cms-clia-laboratory-quick-start-guide-remediated.pdf
Changes to accredited laboratory CLIA certification must contact the accrediting agency first. Please contact our office to inform of the changes. Please contact our office with any questions.
If you are requesting to perform temporary screenings or health fairs in Washington DC with an out of state CLIA license. Multiple test sites that include mobile or temporary screenings must be added on your current CLIA certification. When necessary DC Health will require you to apply for DC CLIA certification. Please contact our office with any questions.
CMS CLIA LINKS:
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA
https://www.cms.gov/files/document/cms-clia-laboratory-quick-start-guide-remediated.pdf
https://pay.gov/public/form/start/55598674