Related Experiment Video
Updated: Aug 10, 2026
Colony Forming Cell (CFC) Assay for Human Hematopoietic Cells
Published on: December 19, 2010
Approval of the Commission on Office Laboratory Accreditation for Immunohematology--HCFA. Notice
Insights
The Commission on Office Laboratory Accreditation (COLA) is now approved for immunohematology under the Clinical Laboratory Improvement Amendments (CLIA) program. This allows COLA-accredited labs to meet federal standards for immunohematology testing.
Area of Science:
- Clinical Laboratory Science
- Regulatory Affairs
- Medical Diagnostics
Background:
- The Clinical Laboratory Improvement Amendments (CLIA) program regulates laboratory testing in the United States.
- Accreditation organizations play a key role in ensuring laboratory compliance with CLIA standards.
- Immunohematology is a critical specialty within clinical laboratory science.
Purpose of the Study:
- To announce the approval of the Commission on Office Laboratory Accreditation (COLA) for the specialty of immunohematology.
- To inform clinical laboratories about an alternative to direct federal oversight for immunohematology testing.
- To establish that COLA accreditation provides assurance of meeting federal requirements for immunohematology.
Main Methods:
- Review of COLA's accreditation process for the specialty of immunohematology.
- Assessment of COLA's ability to ensure compliance with federal laws and regulations.
- Comparison of COLA accreditation requirements with CLIA condition level requirements.
Main Results:
- COLA has been approved as an accrediting organization for the full specialty of immunohematology.
- COLA's accreditation process provides reasonable assurance of laboratory compliance with federal standards.
- Laboratories accredited by COLA for immunohematology meet CLIA requirements and are exempt from routine federal inspections.
Conclusions:
- COLA accreditation for immunohematology is a recognized alternative to direct federal oversight under CLIA.
- Laboratories accredited by COLA for immunohematology testing will meet federal condition level requirements.
- These laboratories remain subject to validation and complaint investigation surveys.
Abstract:
This notice announces the approval of the Commission on Office Laboratory Accreditation (COLA), which is an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA) program, for the addition of the full specialty of immunohematology. This approval adds immunohematology to the specialties and subspecialties approved by HCFA in a notice published in the Federal Register on December 23, 1993 (58 FR 68148). We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it for immunohematology meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by COLA for the specialty of immunohematology in lieu of receiving direct Federal oversight and continue to meet COLA requirements would meet the CLIA immunohematology condition level requirements for laboratories. These laboratories performing immunohematology testing are not subject to routine inspection by State survey agencies to determine their compliance with applicable Federal requirements. They are, however, subject to validation and complaint investigation surveys.
