This is my first instrument validation/install.

We currently have an Ortho ProVue as our blood bank analyzer, we also use manual gel and tube.  We are getting a new Immucor Echo.  Can anyone help with the validation of a new instrument.  Can anyone send me  a validation plan they followed before when implementing a new analyzer.  How many different samples used, what types, how many different antibodies..etc.

Also, I assume I need to correlate both instruments along with manual tube and manual gel??

we will be doing type and screens, panels, Cord bloods..etc.

thank you

immucor gives you a wonderful validation guide and forms for your validation, guess they want to reduce the headaches.

Agree with Scott. The validation guide from Immucor is very helpful. You will also want to run a sufficient number of samples for each test you plan on using on the Echo to calculate specificity and sensitivity of the new method compared to your old method(s). The more samples you run, the greater validity your stats will have. I chose to run 50 samples for GrpScreen, Ready ID, Extend I, Extend II, Pediatric, and DAT. You should run samples with all ABO types, Rh positive and Rh negative. If you can come up with samples that have weaker backtypes or samples that react more weakly on front type or Rh type - all the better. If you can find a weak D sample or several weak D samples, that would be good. For antibody screens and IDs, the negative samples are just as important as the positive samples. You want to know if the new method is catching antibodies missed by your old method and if your new method is missing antibodies caught by the old method. I tried to round up a good selection of antibody specificities - anti-D (not RhoGAM), -c, -E, -C, -K, -Fya and/or -Fyb, -Jka and/or -Jkb, -S and/or -s. The antibodies can be frozen, though those samples may not work as nicely as fresh ones. I did my antibody ID validation over a fairly lengthy time period because we just don't see that many on a monthly basis, but I did get some good samples that way. If you are going to run different sizes of tubes, validate that. When I was running my samples to validate a specific test I also selected samples in different collection containers. I ran samples in their original EDTA tubes - 7 ml, 4.5 ml and 2 ml plus samples in 12x75 mm test tubes. If you plan on using capillary tubes, use samples collected in those tubes. Whatever your normal work process is or is going to be, replicate that with your validation so you can see how your instrument is going to perform 'real world'.

One major bonus of doing all this is that you will have a very good feeling for how your instrument and the method perform which makes troubleshooting, training and test interpretation easier. Takes time, but its worth it.

It is always useful to refer back to the user requirement specification (URS) that you submitted to the vendor; to challenge the instrument to meet your required specifications i.e. alerts operator when waste tank is full, can prioritise emergency samples without aborting routine run, can process 100 samples in an hour etc