Resources for Food and Drug Administration (FDA)

CLIA: Special Alert

CMS

Live Blood Cell Analysis (LBA) is a test which is used for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of human beings. The Health Care Financing Administration (now the Centers for Medicare & Medicaid Services) Office of General Counsel (OGC) determined in August, 1997, that LBA was subject to all CLIA requirements. Therefore, any facility performing this procedure must be certified by CLIA and must obtain the correct certificate. Failure to comply with any of the CLIA requirements will result in enforcement actions and/or sanctions being taken.

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