New Instrument set up

For our waived instruments that go to our satellites we have them sent to POCT before they go out and we only do QC usually.  If there is a linearity kit available maybe you could use that instead of patients.

The CLIA requirement for waived instruments is just to follow manufacturer's instructions. Usually this is just to perform QC; I'm not aware of any instruments that require patient specimen comparisons. If it's a new method, we have in the past done some patient comparisons with the lab (i.e. we get a urine specimen that was done in the lab and compare what we get on the clinic device). This is not required, nor is precision. If we are putting in a device that we already have at other clinics, then we know the methods are comparable, and we do whatever the manufacturer requires. Normally, that is QC; sometimes they require that each new operator perform QC.

Similar to the other responses, we check the manufactures recommendations.  With most of them not having anything specific for waived testing, we run QC in duplicate over two days and run linearity if available.

Hi Elizabeth!
There are no written guidelines, other than manufacturer's package insert, for waived (CLIA only..not accredited) testing. So best practice is what you make of it. I can use a couple scenarios. For Flu A&B or Covid waived testing in our practices, we were able to correlate to main lab microbiology methods. Running QC multiple times and running samples on both waived POC and main lab method seemed like a good practice to us. This was discussed with our POC medical director, our team and the manufacturer.  Use your resources and ask the manufacturer what others are doing too. Our need was to show what results looked like at the POC and what might change/or not change with same sample to main laboratory. For lead testing, we ran QC only. Getting larger or multiple samples from that population was not a tackle we wanted. 

I think the concept is to prove what you can with what you have available. Waived testing is clearly defined by CMS and thus would not need to adhere to the same stringent validations, non accredited. 

Good luck!!

Erika