CLIA Information

Clinical Laboratory Improvement Amendments (CLIA)

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.

Achieving CLIA Certification

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

We are licensed in all US states except for NY and NV.

CLIA Certification

(CLIA ID Number: 21D2062464)

Medical Laboratory Permit

7/01/2015 – Non-Expiring

CAP Information

The College of American Pathologists (CAP) 

The College of American Pathologists (CAP) is composed of pathologists certified by the Board of American Pathologists. The college is a leader in laboratory quality assurance and promotes excellence in healthcare. The purpose of CAP laboratory accreditation is to ensure laboratories provide precise test results for accurate patient diagnoses, meet CLIA requirements, and demonstrate compliance with professionally and scientifically sound and approved laboratory operating standards. The CAP laboratory program was provided decision-making authority by the Centers for Medicare and Medicaid Services (CMS), which, in addition to being recognized by the Joint Commission, permits CAP inspection on the behalf of CMS.

Requirements for CAP Accreditation

Achieving CAP accreditation is a two-year process that encompasses inspection by a CAP-assigned inspection team that determines compliance to specific laboratory standards and identifies any deficiencies for correction prior to accreditation. CAP-accredited laboratories must have a quality management program that validates the quality and safety of laboratory medical services. External quality assurance (also called proficiency testing) establishes laboratory quality and is monitored on a continual basis. Laboratories performing next-generation sequencing have validated sample preparation, library creation, and amplification protocols. Policies exist for the reporting of sequence variants and the re-validation of instrument and other upgrades. Quality assurance of bioinformatics systems must be documented, and accredited laboratories must meet requirements for the methods of storing and confidentiality of data.

Macrogen was awarded CAP certification in 2017.

CAP ID: 8742212

CAP Certification

(CAP ID Number:8742212)

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