COLA Wins Five-Year Nod to Accredit Organ-Match Labs
Published Date: 6/10/2026
Notice
Summary
Great news! COLA is now officially approved to check labs that do histocompatibility testing, which helps match organ and tissue donors with recipients. This approval lasts five years, from July 10, 2026, to June 10, 2031, and means labs have another trusted option for accreditation. If you run or work in these labs, get ready for a smooth new way to stay certified without extra costs.
Analyzed Economic Effects
5 provisions identified: 3 benefits, 2 costs, 0 mixed.
COLA Granted Deeming Authority
CMS has approved the Commission on Laboratory Accreditation (COLA) to accredit laboratories for the specialty of Histocompatibility and granted COLA deeming authority for 5 years, from July 10, 2026 to June 10, 2031. Laboratories accredited by COLA during that period may be treated as meeting CLIA requirements for that specialty.
Fewer Routine State Inspections
If your histocompatibility laboratory is accredited by COLA during July 10, 2026 through June 10, 2031, CMS says you may generally not be subject to routine inspections by a State survey agency because COLA accreditation can serve as evidence you meet CLIA requirements. This applies specifically to the specialty of Histocompatibility while COLA’s deeming authority is in effect.
Federal Validation and Complaint Surveys
Even if accredited by COLA, histocompatibility laboratories remain subject to Federal validation inspections on a representative-sample basis and to complaint-driven inspections performed by CMS, its agents, or State survey agencies. These federal checks are an ongoing process while COLA’s deeming authority is in effect.
Probation or Withdrawal Risk for COLA
CMS may impose a probationary period of up to 1 year or withdraw COLA’s approval before June 10, 2031 if COLA fails to maintain requirements equal to or more stringent than CLIA or if widespread problems exist in monitoring, inspection, or enforcement. CMS will publish a Federal Register notice explaining the basis if approval is removed.
Enforcement Reporting and Appeals Process
COLA must report actions that deny, suspend, or revoke a laboratory’s accreditation to CMS within 30 days and provides an appeal process for laboratories that have had accreditation denied, suspended, or revoked. Those procedures apply to COLA-accredited histocompatibility laboratories while COLA’s deeming authority is in effect.
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