I am about to venture into performing my first ever validation of a test. I have been tasked to validate Rh+K phenotype testing on the BioRad IH-1000 (two of them). We have been, until now, performing the test manually, but as work is getting busier, performing it on the analyser might prove easier (or at least motivate people to perform phenotype). I have been given advise by my senior on how to go about it:
Select 10 Donor Red Cell units which have Rh+K phenotype performed Perform the phenotype manually Perform the phenotype on the analyser compare the result pat myself on the back, provided I don't mess it up The issue I have is donor red cells doesn't indicate if they are K+, and I wanted some K+ as well as K-. I could always keep testing a lot of donor units until I come across a K+ unit, but I don't want to was a lot of cards (but that might be my last option). If I choose the NBS or BioRad Antibody Panel Cells, then the issue is the strength of the test cells, as they are, I think, 0.8%, and it does not fully represent the way we perform our phenotype manually, as it uses around 5%. I can always try and make the strength of the solution stronger, that is another option.
So this is where I am at. If anyone has a suggestion, or better a complete plan, then I am happy to hear it. Also if there is any point I missed or need clarification, please feel free to ask, I'm fixed to this specific thread all night long.
We are going to be moving forward with testing cord blood gases. We currently run venous gases and arterial gases on our ABL 800 series. Now since a cord gas is still technically a blood specimen, does this require a new set of validation? We are not running reference ranges with this, so I don't know if that would make a difference.
Thanks for any input.
By Janet C.
We recently got a new freezer for the Blood Bank. I am performing my first validation. I am comparing the NIST against the digital display as well as the chart and our own, seperate thermometer. I cannot find any documentation to support how much difference is acceptable between the NIST and the digital read/our thermometer/ etc. Some places I have read say 0.5 degrees which seems very tight to me. Another facility I work for uses 1.0 degree difference which seems more acceptable and able to obtain but I have not found any supporting documentation anywhere!
Can someone help me? When validating, what difference is acceptable between the NIST and the other thermometers, be it the probes in the unit or your own internal thermometers?
Need some guidance on validation of blood warmers. Recently our clinical engineering bought 24 new blood warmers, same model and brand of what we have already used and validated. We have just recently validated 6 of the 24 new ones with running blood through them and taking whole blood potassium levels at hourly intervals.
The question we cannot agree on is do we need to validate every single blood warmer or is the 6 that we have done a sufficient sampling to be able to make a blanket statement that the warmers are ok for patient use. Anyone have any evidence based answers to this? At this point I'll take just some good advice! Thanks in advance.