News-At-A-Glance: CLIA Gets in on Glucose Meter Issue

During a July 2 webinar, Ann Snyder, a medical technologist for the Division of Laboratory Services for the Centers for Medicare and Medicaid Services (CMS) in Baltimore said that if a Clinical Laboratory Improvement Amendments (CLIA) surveyor inspects a laboratory and finds it using a glucose meter on patients other than those allowed by the package insert, they will cite the laboratory under existing CLIA standards using a CMS 2567 citation form. Snyder said CMS will not be looking to shut labs down and every lab will have an opportunity to correct any deficiencies noted by the surveyor. She also emphasized that the two recently published Food and Drug Administration documents on glucose meters are intended for manufacturers, not clinical laboratories. If a laboratory wants to use a glucose meter “off label,” it must meet the requirements of a high-complexity CLIA lab. Translation: labs can be cited with a CLIA deficiency if they are inspected by a CLIA surveyor today and found to be in violation of the off-label rules.