Ensis01

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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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The IT department and software company should be jointly setting up and validating. You explain in excruciating detail to your IT people what you need and they make sure it can / will be done. Find out how imported history will be displayed and will there be a difference between imported and entered data. For example will special needs be imported as a comment or as a hard stop. Will comments have a maximum number of characters per comment or in total. ABO subgroups etc. What I am saying is; more important than percentages (as most are straight forward) find a variety of unusual patient histories and check with IT and the software rep to ensure their history will be imported to your satisfaction. Once imported you are stuck. There is a strong argument not to import. This will allow a clean database that you know is consistent and accurate. When you do a history search you search the old system and put a comment in the new system saying search done, information transcribed, date and initials of who did the search. If you are cautious you cold set up a policy of two history searches and the old system then need not be searched.

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My experience is that interference from rouleaux and cold autoantibodies in Gel is not unusual but this may depend on your patient population. As rouleaux is not an antibody an AHG crossmatch is not required. If you IS crossmatch you must (in my opinion) saline replace so you show any agglutination is interference and can therefore enter a negative/compatible/non-reactive result into your LISS, probably with a comment.

The was a thread about this recently you could start with: https://www.pathlabtalk.com/forum/index.php?/topic/10288-typenex-bands-should-they-stay-or-should-they-go/&tab=comments#comment-77667