Are the following devices considered laboratory tests – breathalyzers, continuous glucose monitoring systems, pulse oximeters, and transcutaneous bilirubinometers?
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.
Related Questions
- Are the following devices considered laboratory tests - breathalyzers, continuous glucose monitoring systems, pulse oximeters, and transcutaneous bilirubinometers?
- How do the features of the FreeStyle Navigator system compare to other continuous glucose monitoring systems?
- Is it legal to sell or give OmniPods or Continuous Glucose Monitoring Systems (CGMS) to another person?
