and meet the additional CLIA regulatory requirements for high-complexity testing as well as any applicable state regulations. Compliance with these rules, however, does not eliminate the off-label use of a glucose meter. In addi- tion to patient safety concerns, the off-label use of a glucose meter in critically ill patients raises regulatory and legal concerns that may have important implications for both providers and patients.

Consequences under CLIA Figure 2. FDA Glucose Meter Guidance Documents

glucose meters following sentinel events in at least two New York State hospitals in early 2014, which required greater scrutiny of the use of these devices in hospitals. As with the performance criteria, much of the informa- tion presented in these articles was not evidence based. The concern was that the cleared device did not include the use of capillary whole blood testing in critically ill (vulnerable) patient populations within all healthcare settings. It was thought that this regulatory limitation would compromise diabetes research in these patient care settings.

Subsequently, and after the FDA’s Advisory Panel4 on capillary whole blood, the same device was cleared (k181043) for use by CLIA-waived operators with all patients in all healthcare settings with all specimen types. The device was then classified by the FDA as the only “Prescription Use Blood Glucose Meter For Near Patient Testing” (Product Code PZI).6,7

The FDA had established a clear pathway for clear- ance of devices based on the evidence submitted by this manufacturer over several significant submissions drawing from very large prospective and retrospec- tive (Real World Evidence) datasets, with a combined N=>20,000 paired glucose measurements comparing arterial, capillary, and venous whole blood to central laboratory traceable plasma glucose results. These clear- ances and the new classification have profound implications for use by providers under CLIA ‘88. Use of other devices classified as OTC SMBG (Product Code NBW) based on the FDA guidance is considered off label in hospitals14

because these devices have not been

evaluated for use in these facilities and, specifically, in vulnerable populations such as critically ill patients. Off-label use under CLIA ‘88 requires providers to restrict the use of these devices to CLIA-waived operators. This has significant operational considerations within hospitals as to who can perform testing in vulnerable patients includ- ing critically ill. When a provider chooses to use a glucose meter off label, the hospital and laboratories must possess a CLIA Certificate of Compliance (CoC) or Certificate of Accreditation (CoA), establish the performance specifica- tions (i.e. accuracy, precision, analytical sensitivity, speci- ficity including interfering substances) and other perfor- mance characteristics for use in their patient populations,


Figure 3. Self-Monitoring Blood Glucose Test Systems for Over-the- Counter Use

a. This requires submitting a corrective action plan to CMS or its designee, the College of American Pathologists (CAP). b. CMS can suspend or revoke a Certificate of Waiver


c. CMS can cancel a provider’s approval for Medicare reimbursement for failure to comply with the corrective action plan in a timely manner.

Because the conditions for CLIA-waived status (that a test be simple and have a low risk of erroneous results) have only been demonstrated for the test when used according to its labeling: 1. Glucose meters lose their status as CLIA-waived tests when used off label and are considered high complexity tests. 2. If a facility wishes to use a BGMS off label (e.g., in a critically ill patient population when a manufacturers’ instructions contain a limitation on critically ill patients), laboratories with a [CLIA waiver] may: a. Obtain a CoC or CoA

b. Establish performance specifications [(i.e. accuracy, precision, analytical sensitivity, analytical specificity including interfering substances, reportable range of test results, reference intervals, and any other performance characteristic required for test performance) for use in their patient population]; and c. Meet the additional CLIA regulatory requirements for high-complexity testing and any applicable State regulations. 3. A laboratory/hospital performing high complexity testing that doesn’t meet the requirements is subject to a notice of deficiency.

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