Approval of the Commission on Office Laboratory Accreditation for Immunohematology--HCFA. Notice.
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.
D000068:Accreditation / Q000331:legislation & jurisprudence*; D014487:Centers for Medicare and Medicaid Services, U.S.; D006403:Hematologic Tests; D007158:Immunologic Techniques; D007753:Laboratories / Q000331:legislation & jurisprudence / Q000592:standards*; D014481:United States