Echo validation

[Tony R]

I was told this morning that we will be getting an ECHO and that I should get started preparing things. If any one would be nice enough to share their validation protocol for the echo I would be indebted for life. If so please let me know.

Thanks for your time

Tony

[dmpollock]

When you get your echo you will get a pre-written validation book which will be very helpful. They will not give you guidelines on how many samples for correlation. We chose 40 as the minimum, but ran more.

You need to decide how you are going to use the instrument to know what tests to validate. We use it for ABO/Rh, antibody screens, and panels.

We will not use it for DAT's since the method is IgG only and DAT's should be run with polyspecific AHG. We will not use it for crossmatching units since the method will not pick up ABO incompatibility reliably (IgG only). We will not use it for cord blood testing because we don't want to clog it up with clots.

Are you planning to interface to a lab system?

We set up our interface in the test system. We set up fake patients with all 8 blood types, and ran them all on the ECHO to ensure they all transmit properly. We also test samples with pos and neg antibody screens.

We then switched the interface to live, and are testing 100 samples currently. Under "general options" I changed the facility name so that instead of just having our hospital's name it says "History_____ Interface transfer OK_______ Hospital name"

For the first 100 interfaced patients we are printing out the report after the Echo runs the test. Then we document the history check on the report. Last step we accept the interfaced results. If the LIS matches the Echo report, we mark "yes" on the "Interface transfer OK block"

Since about half of the interface validation samples already a historical type, I will be able to add the 50 or so samples results to the initial correlation data.

[krichards]

Our validation process was almost identical to dmpollock's. We validated approximately 50 samples for each test. We also have chosen not to run cord bloods or crossmatches on the Echo.

It may help to know that our installer told us that the Echo will not reliably pick up "fake" antibodies that you make up with antisera. I have not yet tested this to see if that's really the case. Because of this, we froze some of our known patients until we were ready for validations, and had no problems.

Once the LIS interface was built, I validated with about 50 more samples for each test.

The entire implementation went very smoothly. Since our techs were eager to try out our new "babies", there were plenty of volunteers willing to help out with the validations!