Mobile Units and POCT
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We have a hospital in NY that has a mobile PET scan unit coming onto hospital grounds to scan patients. They want to have their Rad Techs use our glucose meters for patient testing.
Can we train the companies' techs to use our meters (on hospital grounds) under our CLIA and be compliant? The mobile unit does not have a CLIA to perform testing in NY.
Has anyone had this or a similar experience?
Can we train the companies' techs to use our meters (on hospital grounds) under our CLIA and be compliant? The mobile unit does not have a CLIA to perform testing in NY.
Has anyone had this or a similar experience?
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We have a similar situation here--there is a PET Scan mobile unit that provides services at the different facilities that are part of our organization. The only difference is that this mobile unit is part of, and is staffed with our Nuclear Medicine department. Therefore, they are under our laboratory CLIA certificates, and we have been managing their training, competencies and quality assurance in general. This PET Scan mobile unit uses our glucose meters and iSTAT to provide glucose and creatinine respectively. Both analyzers and interfaced to our medical record, therefore, they are in our rotation list for software upgrades and other regulatory requirements.
We also have other mobile medical units such as the ECMO Resuscitation team and Organ Transplant Research Team that perform iSTAT testing, however, they are private entities, and even though we support them with the required iSTAT software upgrades, their test results do not interface to our LIS, and we don't manage their instrument and staff quality assurance and competencies. From the beginning, we advised them to get a CLIA certificate so they can manage their own operations.