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.
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.
Manual:
Home Care
Chapter:
Provision of Care Treatment and Services PC
Last reviewed by Standards Interpretation: July 12, 2022
Represents the most recent date that the FAQ was reviewed (e.g. annual review).
First published date: April 11, 2016
This Standards FAQ was first published on this date.
This page was last updated on July 12, 2022
with update notes of: Review only, FAQ is current
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