David Saikin

And in this vein - look at all the ABO incompatible plts we are forced to give (esp when you can only get group O)

I think it depends on what is going on. Look at the history of liver transplants. When they started, pts were getting upwards of 400u rbc. The first 20 and last 20 were abo compatible. in between it was whatever was available. I've seen massive transfusions where the patient was mistyped, receiving 20+u incompatible rbcs. Everything was fine for a few days - until the dilution factor was overcome by the pt's own immune system coming back on line. Patient doesn't survive that. Maybe, if you have to go with significant ABO incompatible plasma (O) you could switch the pt to O rbcs to reduce hemolytic activity. Have to remember the ABO abs are going to be diluted by the volumes of other solutions which are usually being infused at the same time. If the need is for coag factors, pharmacy should be able to provide recombinant products. It's a tough nut.

Those are 2 distinct systems. They each need to be qc's day of use.

I don't think I have ever QC'd any of these reagents except enzymes. What we've done in the past was evaluate the different LISSs to see which gave us the best results. After that we just followed the manufacturer's directions. I would do daily what you now do on your day-of-use. The efficacy of the product in enhancing reactivity can be achieved by running a weak antibody at regular intervals (from Immucor Enhance package insert). You would need to determine what reactivity is acceptable at your institution. Not much help

I think you have to start by determining what components you are making. Then you have to find the standards for that component in your country - for example, in the USA if you are making packed red blood cells, when you QC your products, 75% of those tested have to have a hematocrit of </= 80%. You then have to determine how much centrifugation you need to accomplish that efficiently. When you are happy with your process you will need to perform QC on a routine basis (monthly, Quarterly - check your country's requirements). Packed cells are probably the easiest to make (except for additive solution red cells). Platelet concentrates take a great deal of time. I recommend obtaining a copy of the AABB Technical Manual. This should provide the information you require for all component prep and QA/QC. Very labor intensive depending on what you are making. Good luck.

Don't the regs say that they must agree w NIST within 1C? Why would you correct if they meet that criteria? Years ago the regs were +/-2C for therms in freezers but now it is 1C. The only correction I have to do is for my NIST based on its annual calibration.

I've used the cytotherms and the D4. I think the cytotherms are a lot of work to keep up, especially if you keep them full. I've had the D4 for at least 8 yrs - no rust but I keep it empty. reasonably fast (16-20 minutes for 4u). I can go for months without thawing a plasma.

Are you talking about LISS/PeG (AES)?

that's right - in the CFR. The feds can take you to jail if they don't like what you are doing. Everyone else - you can amend your SOP if you need to.

I always preferred running positive and negative controls. FDA only requires that for anti-D (and gel). I also dislike the attitude of doing the minimum. We QC our gel and tube reagents w pos and neg controls.

Yes - that is a new product, manufactured by you. Have to at least be FDA registered also.

I have not had problems using the Immucor elution kit. Been using it with gel for 15+ yrs. Am not familiar with HB kit.

Gerbich antibody?

If I am qcing gel - I use the diluent as a neg control. If I am qcing tube reagents, I only test a pos and neg w anti-D, otherwise, only positive qc. (personally, I think that tubes should be qc'd pos and neg but it is not required in the US (FDA).

I love this card. Had the opportunity to try it (thanks Malcolm). Too bad it's not available in the USA. I do not usually run a control with my IgG cards. When I test w anti-C3b,-C3d I use my A2 cell as a negative control/C3 sensitized cells as positive.