ProtaGene’s Heidelberg, Germany, lab has received CAP and CLIA accreditation, authorizing integration site analysis on human samples for lentivirus-based cell and gene therapy under U.S. federal regulations.
The accreditation covers liver health diagnostics, including Hepatotrack, a molecular diagnostic liquid biopsy that is predictive of acute liver rejection post-liver transplant.
CMS granted COLA an extension of its deeming authority for an extra six years under the Clinical Laboratory Improvement Amendments of 1988.
The Accreditation Committee of the College of American Pathologists (CAP) awarded accreditation to Immunovia following an onsite inspection.
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The Centers for Medicare and Medicaid Services (CMS) has awarded COLA deemed status for the pathology specialty. Â
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Clinical diagnostic lab company Artemis DNA received an accreditation from the College of American Pathologists (CAP) for its Irvine, California facility.
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Hospitals, ambulatory surgery centers and laboratories can now access Meeting the Challenge,...
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The Kentucky laboratory was built in response to the COVID-19 pandemic to help ensure the health and safety of Amazon’s frontline employees by providing them with regular, reliable access to free COVID-19 testing.
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The Association for Molecular Pathology and the Association of Pathology Chairs have voiced their support for the Verified Innovative Testing in American Laboratories (VITAL) Act of 2021.
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The Joint Commission Board of Commissioners has begun the search process for the next president and CEO.
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COLA CEO Nancy Stratton offers a perspective on the impact covid-19 has had on clinical labs.
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Online payments are processed overnight, substantially faster than hard-copy checks, which can take up to 10 business days to process.
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The audit from the British Standards Institute extended its ISO certification to COLA’s newly launched FDA Third Party Review Services.
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Laboratory Accreditation Program services include on-site and post-survey reviews, ongoing monitoring activities, and data and measurement activities.
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The virtual laboratory survey process consists of three parts: documentation, review, and a video conference.
Read MoreUpdates include new criteria in the areas of immunohematology, transfusion services, and mass spectrometry.
Read MoreHNL underwent a rigorous onsite inspection, including verification of the academic and professional qualifications of the laboratory’s management team, personnel training, specimen handling, analytical procedures, and quality assurance program.
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The International Society for Cell and Gene Therapy is leading a global consortium to oppose unproven cell therapies and services in the cell and gene sector.
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