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A CLIA Certificate of Compliance (CoC). Per CLIA, each specific laboratory system, assay, examination is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the following seven criteria. A score of 1 is the lowest level of complexity, and a score of 3 indicates the highest level.
In 2001, California enacted phlebotomy licensure following a public health outcry about an on-the-job trained phlebotomist that re-used needles. [15] [16] California has two levels of phlebotomy licensure: Certified Phlebotomy Technician I (CPT I) – authorized to perform skin puncture and venipuncture blood collection. [17]
NAACLS accreditation allows students to sit for their certification at the completion of their program in addition to being a stamp of program quality. All the three national accrediting agencies will certify scientists in the clinical laboratory as generalist (chemistry, hematology, immunology, immunohematology/blood bank, and microbiology).
The American Board of Clinical Chemistry (ABCC) is an American doctoral board certification agency for clinical chemistry, toxicological chemistry, and molecular diagnostics. It was founded in 1950 with sponsorship from the American Chemical Society (ACS), American Institute of Chemists (AIC), and the American Society of Biological Chemists. [1]
Accreditation by AABB meets the requirements of the Clinical Laboratory Improvement Amendments (CLIA) for blood bank, transfusion service, and immunohematology reference laboratory operations. [ 2 ] AABB hosts an annual meeting every fall for the dissemination of research and information for the blood and biotherapies field.
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CLIA may refer to: Chemiluminescent immunoassay; Clinical Laboratory Improvement Amendments; Cruise Lines International Association This page was last edited on 20 ...
Under the CLIA, it is the role of the FDA to assess the complexity of the in vitro laboratory diagnostic tests. [33] Tests are only scored after the FDA has cleared or approved a premarketing request, or upon request. [36] Manufacturers can apply for CLIA waivers during this premarket approval/clearance process.