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“Consequences of FDA Changes to Critically Ill Bedside Glucose Testing Regulations”

Nova Biomedical* presents… “Consequences of FDA Changes to Critically Ill Bedside Glucose Testing Regulations”

Part I: Clinical Consequences  |  “Venous, arterial, and now capillary specimens are all FDA cleared for testing critically ill patients – Are all specimen types analytically and clinically equivalent?”

The choice of specimen type is an important consideration, particularly for critically ill patients. This presentation will cover the analytical performance differences between different specimen types and their clinical significance. The data is based on the results of an FDA comparison study of 16,778 paired patients test results.

Part I Learning Objectives:

  • Analytical performance differences
  • Clinical significance of these differences
  • Suggested best practice testing procedures

Part I presenter:

Jeffrey A. DuBois, Ph.D.  |  VP of Medical and Scientific Affairs  |  Nova Biomedical

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Part II: Regulatory/Legal Consequences  |  “Regulatory requirements for off-label testing and the consequences of non-compliance”“

One meter is FDA cleared and CLIA waived for use with all patients including critically ill. Use of all other meters with any critically ill patient population is considered off label by FDA and CMS. Hospitals cannot change the FDA’s off-label testing designations using their own testing or definitions. This presentation will review the history and rationale for recent FDA changes to bedside glucose testing in critically ill patients and the regulatory and legal consequences of off-label testing for caregivers and hospitals.

Part II Learning Objectives:

  • The history and rationale for the FDA’s requirements for off-label bedside glucose testing from 2010 to 2018
  • Understand when bedside glucose testing is off-label
  • FDA testing requirements for off-label bedside glucose testing
  • Patient risks if off-label testing is used for critically ill patients
  • Caregiver’s personal liability risks when performing off-label glucose testing
  • Hospital liability risks when performing off-label glucose testing
  • CLIA risks when performing off-label glucose testing

Part II Presenter:

Natalia Mazina, Esq. |  Compliance Attorney |  FDA

Continuing education credits |  Lab and Nursing  |  This program is accredited by the Society for Clinical Laboratory Science, American Association of Critical Care Nurses, American Society for Health Care Risk Management, and ACCENT to offer a total of 1.00 CE credit (1.00 max).

Questions should be directed to Nova Biomedical: (781) 894-0800 |  info@novabiomedical.com

* NOTE: This is a contracted supplier-sponsored webinar. HealthTrust has not approved and/or endorsed the content. This program may contain the mention of products, services, drugs or brands presented in a case study or comparative format. Such examples are intended for educational and informational purposes and should not be perceived as a HealthTrust endorsement of any particular supplier, product, service, drug, brand or approach.