The Centers for Medicare & Medicaid Services (CMS) regulates all clinical laboratory testing performed on humans in the United States through the CLIA. The goal of the CLIA program is to ensure quality laboratory testing. The amendments regulate the entire process within the laboratory for accurate and consistent sequencing results for clinicians and patients.
CLIA certification requires two proficiency tests (PT) every year. Full validation is required for all instruments for clinical testing, and validation is reviewed every two years by CMS surveyors.
In addition, all workflow, standard operating procedures, and personnel (including personnel credentials) are tightly regulated and approved by the CMS. Facilities and instruments are closely monitored with readings recorded automatically 24 hours a day, seven days a week. All corrective actions are documented, including a complete summary of the event, and signed by the Lab Director after the full review.
All clinical laboratories must be CLIA certified to receive Medicare or Medicaid payments, though the CLIA have no direct Medicare or Medicaid program responsibilities.
Macrogen was awarded CLIA certification in 2013.
CLIA ID: 21D2062464
(CLIA ID Number: 21D2062464)
Medical Laboratory Permit
7/01/2015 – 6/30/2017
We are licensed in all US states except for NY and NV.