CLIA was created in 1988 to establish quality standards for all laboratory testing. It is through CLIA that the Centers for Medicare and Medicaid Services (CMS) is responsible for overseeing all the laboratory testing performed on humans in the U.S., except for clinical trials and research.
Some responsibilities of our CLIA team include surveying, certifying and recertifying laboratories for participation in Medicare and Medicaid programs based on federal and safety standards. Our CLIA survey team ensures that laboratory facilities performing tests on human specimens obtain proper CLIA certification and comply with CLIA regulations. The team also makes recommendations to CMS regarding survey findings and investigates complaint allegations of CLIA violations.
CLIA team members (left to right): Mary Jo Roue, Lakeisha Wright, Ashley Gibbs, Kiawania Reed and Amelyn Olson.
“DHEC’s role with CLIA entitles quality standards for laboratories to ensure the accuracy, reliability, and timeliness of the patient’s results,” said Kiawania Reed, Bureau of Certification. “I make a difference by promoting teamwork, serving the community, and assuring achievable standards of quality and professionalism in our pursuit of healthy people living in healthy communities.”
Our CLIA Program must meet CMS performance expectations annually. CMS conducts a review every year to assess DHEC’s ability to meet specific performance standards and to evaluate our performance of CLIA surveys and certification activities. Our CLIA team has met100 percentof all performance standards for the past two consecutive federal fiscal years.
Many thanks to the members of our CLIA team for their hard work!