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Test Category - Monitoring Devices

Are the following devices considered laboratory tests - breathalyzers, continuous glucose monitoring systems, pulse oximeters, and transcutaneous bilirubin meters?  

Any examples are for illustrative purposes only.

These analyzers are approved by the FDA as monitoring devices and are not considered laboratory tests. Therefore, they are not regulated by the Joint Commission's specific laboratory standards. As monitoring devices, they should at a minimum be managed following manufacturer's guidelines. This includes performance of calibration, controls, and maintenance, as applicable. Written policies and procedures should be readily available to the staff using the equipment. In addition, staff should have evidence of training and competence, as required by the HR standards.
Last updated on March 17, 2021
Manual: Ambulatory
Chapter: Provision of Care Treatment and Services PC

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