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Medical (Clinical) Laboratories

Two Lab Technicians working in a Medical (Clinical) Laboratory

Medical (Clinical) Laboratories in Colorado are registered through the Certification Program under the federal regulation known as the Clinical Laboratory Improvement Amendments (CLIA).

 

All labs which perform testing on human specimens for diagnosis, treatment or health assessment in the United States are required to hold the appropriate type of CLIA certificate.  These federal regulations foster good medical laboratory practices to protect all citizens. The CLIA regulations set standards for personnel, records, quality control and quality assurance. The greater the complexity of a test, the greater the requirements.

Compliance Oversight:

The Federal Centers for Medicare and Medicaid Services (CMS) agency is responsible for achieving regulatory compliance. CMS has delegated compliance inspections and management of application information to state health departments.

 

How to Report a Complaint About a Laboratory's Operation:

 
Apply for CLIA Certification or Update Existing CLIA Certification

 

Inspection Schedule:

Laboratories that conduct complex testing are inspected every two years. Inspections may also arise from a citizen complaint against a medical laboratory.

 

Additional Resources:


CDPHE Laboratory Services Division's Certification