Ensis01

Agree with Malcolm and OkayestSBB. The process I would suggest is to only investigate then call Ch/Rg once the following criteria are met: there should be reactivity on phenosimilar cells, which should titer out to your HTLA defined policy. Reactivity should be negative with Ficin treated cells and positive with 0.2M DTT treated cells. Then neutralize with plasma (and saline controls). Hope that helps.

I agree with the consensus. I would however check each and every card against Meditech to ensure nothing extra is on the card, once checked (updated) make a note in Meditech and discard the card. Also keep the unused cards as they are fantastic for use during down time events and can be discarded once Meditech is updated.

At my previous hospital we would accept and use a historical ABO from another lab but only if it came from within our hospital system.

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If you provide blood for the outpatient surgery center it makes no sense to have two separate procedures for emergency releasing blood otherwise you would need two procedures for EVERY process that you do at both sites, and that would really suck

Finish the unit.

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Ensure the centrifuge and temperature calibrations meet the BB requirements. Also is the the maintenance schedule and who performs it acceptable? If the above fit your criteria I see no problem (I also can not site any regulations).

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Several years ago we had a call from the OR asking if there was any history on a patient X to determine if one collection or two separate collections were required. The BB tech who answered the call did a history search and said we have no BB history on patient X. Ten minutes later two samples for a patient Y arrived. The same BB tech called the OR to clarify why samples on patient Y were delivered when we were expecting patient X. The OR said patient X samples had been delivered. Not said the BB tech; and demanded two recollections by different people. What had happened was patient X was moved to a different OR and whoever collected the samples used the labels in the new OR, patient Y (the labels for patient X were in the old OR). As whoever drew the samples recorded them as different collections; they were written up with two Wrong Blood in Tube events, which resulted in their termination. We typed the incorrect samples from curiosity and an O+ patient would have received A+ blood!!!!!!

0.2M DTT is used to treat red cells (deactivates/cuts Sulphur bonds: CD38 in DARA patients and several HTLA antibodies). 0.01M DTT is added to plasma in a process to differentiate between IgG and IgM antibodies. In my opinion using 0.2M DTT in a hospital setting for DARA patients makes sense WRT time and money. But the other uses of DTT (HTLA, IgG/IgM antibodies etc.) are too time consuming to justify, especially in a busy (or short staffed) hospital.

Indefinitely

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While I agree with the outcome you describe. I believe (maybe naively ) that it will be designing, implementing and coordinating this massive logistical challenge, that I struggle to imagine, plus communicating the process to provide and manage expectations that will be the primary problem. The inevitable failures will be perceived as incompetency, deserved or not.

My logic is that as the FDA categorizes blood products as a drug I don’t see why they could/would have a problem. You may however want to clarify who will have freezer(s) access to stock and issue the vaccine etc.

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Congratulations; well deserved

The “always type and screen” does have the advantage that it keeps it simple from the ordering perspective in that if red cells are needed later you are ready. Plus by giving no choice about what to order it means you do not have to explain the difference when it is busy

Historical for platelets and current admission for plasma.

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Manufacturers calibrate the electronics and provide the certificate on the assumption of power to the electronics (which are simple and robust). As you did not change the electronics when changing batteries (the power input) you do not need to conduct a performance check (calibration). Or to put it another way: You do not recalibrate equipment after a power cut or if you remove and replace a mains plug.

I am not sure how helpful this will be but my experience with scales is that your facility determines the frequency of calibration not the manufacturer because it depends on what the scale is used for and your precision and accuracy requirements. That being said one external annual calibration of a scale is good as long as there is a daily (or before use) performance check. The performance check uses your "calibrated weights". One place I worked I got the "third party" to calibrate our weights against their very accurate high quality weights just after they finished calibrating the scale.

Congratulations and well deserved

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