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Clinical laboratories in the US that perform high complexity testing require a high complexity laboratory director (HCLD) that has earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS.
Regardless of terminology, these highly qualified individuals serve as scientists in the clinical laboratory. There are two other organizations that have previously provided proficiency examinations to clinical laboratory scientist. The first, is the US Department of Health and Human Services. [34]
NAACLS is the primary accrediting body for clinical laboratory programs in the US, though the Accrediting Bureau of Health Education Schools(ABHES) also accredits a handful of programs. [1] Graduates of the ABHES are not eligible for the American Society for Clinical Pathology (ASCP) certification, but are eligible for the American Medical ...
California introduced phlebotomy licensure after an on-the-job trained phlebotomist at a Palo Alto phlebotomy draw station for SmithKline Beecham Clinical Laboratory (SBCL) was found to be re-using needles, sometimes after washing them with diluted hydrogen peroxide, in an effort to save supplies and run a cost-efficient lab.
The laboratory industry is a part of the broader healthcare and health technology industry. Companies exist at various levels, including clinical laboratory services, suppliers of instrumentation equipment and consumable materials, and suppliers and developers of diagnostic tests themselves (often by biotechnology companies). [22]
Many areas of clinical pathology overlap with anatomic pathology. Both can serve as medical directors of CLIA certified laboratories. Under the CLIA law, only the US Department of Health and Human Services approved Board Certified Ph.D., DSc, or MD and DO can perform the duties of a Medical or Clinical Laboratory Director. This overlap includes ...
The Division of Laboratory Systems ('DLSs) purpose is to improve the quality of laboratory testing and related practices in the U.S. and globally through the development and evaluation of innovative training, technical standards, practice guidelines, and reference materials. [2] Major Products or Services provided by DLS include: [2]
The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.