Additional Instruments (Waived)

When we get new waived instruments for test systems we already have in place, we just do QC to make sure that instrument is reading as it should.  Then we send it to it's new forever home :).  The only exception is our glucometers, we do a linearity on those just because I feel better doing that not because it's required.  

Hi Contessa,

As you have mentioned, there are no CAP/CLIA requirements for test method verification / clinical claims validation of waived tests. The regulatory requirements simply state to follow manufacturer's instructions. Note: more stringent state/local requirements may exist.

First step would be to reach out to the manufacturer to see if they have a "recommended" verification plan for new devices. You should also verify in the IFU to ensure there is no mention of recommended studies prior to use.

If no recommendation from the manufacturer/IFU, next it would be up to the laboratory director to decide what is necessary. At the minimum, their signature/approval on the procedure is all that is needed  (REF: COM.30980 "The laboratory director's signature on the written test procedure may be used to show approval of the test for use in patient testing.").

...exactly what Adonica wrote...

Hi Contessa,

We created a specific, medical director signed  policy to define how we verify additional waived devices. Our process is to run 3 normal controls and 3 abnormal controls. If the results are numerical we calculate the mean, SD and CV, which must fall within our policy's stated acceptable range. If the values are non-numeric the policy states all values must fall with manufacturer's stated range (Ex. detected/not detected). We have a waived device verification worksheet associated with the policy that we complete, sign and keep on file for each additional device. I could share the policy and worksheet if you'd like to review them?

Hi Patricia- yes that would be great!

Hi Patricia,

For glucose meters, QC is performed and if acceptable the meter is put into use.

Could you share your policy and worksheet in the File section? If not, I would love a copy also.
sandrabijani@uh.org

Thank you!