Clinical Laboratory Improvement Amendments (CLIA)

Welcome to Healthcare Facility Regulation Division (HFRD), a division of the Department of Community Health (DCH), is responsible for health care planning, licensing, certification and oversight of various health care facilities and services in Georgia.

Clinical Laboratory Improvement Amendments of 1988 (CLIA) – The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. Exceptions to the CLIA regulations exist for certain testing, including employment-related drug testing by SAMSHA certified laboratories, testing performed for forensic purposes (criminal investigations), and research or surveillance testing performed on human specimens in which patient-specific results are not reported (if the results are not used for diagnosis or treatment decisions). For more information, please refer to CLIA at 42 CFR 493.3.
CDC, in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality. CDC’s responsibilities for the national CLIA program include:

• Providing analysis, research, and technical assistance
• Developing technical standards and laboratory practice guidelines, including standards and guidelines for cytology
• Conducting laboratory quality improvement studies
• Monitoring proficiency testing practices
• Developing and distributing professional information and educational resources
• Managing the Clinical Laboratory Improvement Advisory Committee (CLIAC)
• Law continues to be cited as CLIA ’88 as named in legislation.

CLIA Regulations

The section of the federal regulations titled “Standards and Certification: Laboratory Requirements” is issued by the Centers for Medicare & Medicaid Services (CMS) to enact the CLIA law passed by Congress.  Please see link eCFR :: 42 CFR Part 493 -- Laboratory Requirements to search and view the CLIA Regulations.

CLIA Interpretive Guidelines

The interpretive guidelines to the CLIA regulations are published in the CMS State Operations Manual (SOM). The SOM is used by state offices to administer various federal programs, such as clinical laboratory certification under the CLIA regulations, and enforced by CMS. It is also a source of guidance to laboratories for interpreting the CLIA regulations. The interpretive guidelines can be found at Interpretive Guidelines for Laboratories | CMS.

FAQ

Answers to most questions about the CLIA program can be found at Clinical Laboratory Improvement Amendments (CLIA) | CMS or by emailing the Georgia CLIA State agency at [email protected] or CMS at [email protected].

CLIA application

Information about the CLIA application process can be found at How to Apply for a CLIA Certificate, Including International Laboratories | CMS. Completed applications should be emailed to [email protected]. Please allow 30-45 business days to complete the processing of applications.

Complaints

If there is a concern regarding the safe operation of a clinical laboratory, in the State of Georgia, see CLIA Complaints Booklet (cms.gov) or contact HFRD at 404-657-5726 or 404-657-5728, toll-free: (800) 878-6442.  

Complaints may also be submitted online at https://dch.georgia.gov/divisionsoffices/healthcare-facility-regulation/facility-licensure/hfr-file-complaint.

Record Requests

To request records, you may email your request to: [email protected].

CLIA resources

Additional CLIA information can be found at Clinical Laboratory Improvement Amendments (CLIA) | CDC or emailing the concern to [email protected]. 

Employment Opportunities

The Department of Community Health (DCH) Healthcare Facility Regulation Division offers rewarding employment opportunities that support the agency’s mission to help ensure oversight of various health care facilities and services in Georgia. See https://dch.georgia.gov/divisionsoffices/dch-employment for current DCH vacancies.