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Clinical Laboratory Improvement Amendments (CLIA)
Macrogen was awarded CLIA certification in 2013.
What exactly is CLIA certification? The Centers for Medicare & Medicaid Services (CMS) regulates all clinical laboratory testing performed on humans in the United States through CLIA.
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. 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.
The College of American Pathologists (CAP)
Macrogen was awarded CAP certification in 2017.
The CAP 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.
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 instruments 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.
The CAP is composed of pathologists certified by the Board of American Pathologists. It 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. They foster and advocate excellence in the practice of pathology and laboratory medicine worldwide.
Quotes From Our Clients
"I was very satisfied with Psomagen’s services. They met our needs and gave us quality data, all at a good price point. Their CLIA/CAP accreditation was a huge factor in our decision to use them."
"We chose Psomagen because of their CLIA/CAP accreditation, data quality, and price."
University Research Laboratory