Cliff

While I do believe you, sadly I would not be surprised.

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We use regular zip lock bags for transport in the tube system. White opaque open bags with handles for issue out the window, nothing for coolers. Does anyone have a bag specifically for platelets, maybe ones labelled "Platelets, Do Not Place In Cooler"? We get a modest amount back in coolers, at least a few a month. We also issue over 13k platelets a year, but waste is waste. Someone sat on a machine for 2 hours giving us that gift.

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We are AABB, TJC, and FDA. Also DPH for our irradiators. Our pathology chair wants to switch from TJC to CAP, but that will likely be years away. If we do, we will maintain both AABB and CAP. I will advocate to not have a joint assessment. I'd prefer to have them come at different times to help us be ready all of the time.

In the long ago past, we had to make up our own validations. While not realizing we were doing so, we based them on risk assessments of the process. For instance, what is the risk of switching your Anti-A from one vendor to another? If you follow of the manufacturer's instructions, and they are both licensed by the FDA, the risk is close to zero. In my humble opinion ABO QC is a waste of time. In the tens of thousands of times I've seen it performed in our organization, it has never failed. Regardless, yes we perform QC. Now, you buy a complex analyzer, it is nearly impossible to develop a good risk assessment without the assistance of the vendor. I always start by asking the vendor for a validation plan. Some provide Word docs that you can edit for your own facility. We always do what they recommend at a minimum, and usually more. We've been lucky in that our vendors provides these plans. Moving forward, that will also be part of my negotiation for new equipment, that I will ask for them to include a validation plan.

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