Announcement of the re-approval of COLA under the Clinical Laboratory Improvement Amendments of 1988

A Notice by the Centers for Medicare & Medicaid Services.
March 8, 2024

The Centers for Medicare & Medicaid Services published a notice on March 6, 2024.

The notice announces the application of COLA for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the following specialty and subspecialty areas under CLIA: Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology; Diagnostic Immunology, including Syphilis Serology, and General Immunology; Chemistry, including Routine Chemistry, Toxicology, and Endocrinology; Hematology, including routine hematology and coagulation; Immunohematology, including ABO Group, D (Rho) typing, Unexpected Antibody Detection, Compatibility Testing, and Antibody Identification; Pathology, including Histopathology, Oral Pathology, and Cytology.

It was determined that COLA meets or exceeds the applicable CLIA requirements. The re-approval and grant COLA deeming authority for a period of 6 years was announced. This notice is effective from March 6, 2024 to March 6, 2030.

Visit the Federal Register for more information

About the Author

Sign up for Medical Laboratory Observer eNewsletters