Federal Register #2026-11618

COLA Approved as Accreditation Organization for Histocompatibility Labs under CLIA

This notice announces the approval of COLA as an accreditation organization for Histocompatibility laboratories under the Clinical Laboratory Improvement Amendments (CLIA): - Government buyer: - Department of Health and Human Services (HHS) - Centers for Medicare & Medicaid Services (CMS) - OEM/vendor mentioned: - Commission on Laboratory Accreditation (COLA) - Products/services requested: - No products or services are being procured or requested - The notice is an announcement of regulatory approval, not a solicitation - Unique or notable requirements: - COLA is granted deeming authority for a five-year period to accredit clinical laboratories specializing in Histocompatibility - Laboratories accredited by COLA are considered compliant with CLIA requirements and generally exempt from routine state inspections - Federal validation inspections and complaint investigations will continue as part of ongoing oversight - No contract, procurement, or award is involved; this is strictly a regulatory approval notice

Description

This notice announces the approval of the Commission on Laboratory Accreditation (COLA) as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the specialty of Histocompatibility. COLA has been determined to meet or exceed the applicable CLIA requirements and is granted deeming authority for this specialty for a period of 5 years, from July 10, 2026 to June 10, 2031. Laboratories accredited by COLA during this period may be deemed to meet CLIA requirements and generally will not be subject to routine inspections by State survey agencies. Federal validation inspections and complaint investigations will continue as part of ongoing oversight.

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