The Clinical Laboratory Improvement Amendments (CLIA) include standards applicable to all US facilities (or sites) that test human specimens - for the diagnosis, prevention, or treatment of disease. Medical laboratories in the United States must undergo periodic inspections to demonstrate CLIA compliance. CLIA sections about vendors/laboratory procurement - in comparison with ISO 15189 - include8:
- 493.1242 (8) (c) specimen referral: The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS.
- 493.1252 test systems, equipment, instruments, reagents, materials, and supplies: Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. Components of reagent kits of different lot numbers must not be interchanged unless otherwise specified by the manufacturer.
After reviewing these two CLIA requirements, it becomes apparent that good vendor relationships are important in accomplishing these objectives.
