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Yes, we also validate any new reagent/manufacturer. Since the FDA beats up on reagents before they get to us, you really don't need to do an extensive validation. So for an antisera, we would do parallel testing with the old and new reagent with pos and neg controls, and a known pos and neg unit (segment). We write up a document that it is acceptable for use, FDA approved, etc, and have the Medical Director sign.

We performed validation for each and every reagent from new manufacturer before putting into use. We compared the results. For ABORH and IgG etc at least 20 specimens. For antisera controls and few specimens. As long as your medical director signed off on some kind of validation it would have been OK.

We use a rule that gives the user just a warning. In the event that the BB needed to provide a product w/o the marker, we wanted to have the option to override. This can also be set up as a "hard stop" if you want. How we applied this was to enter this as an assignment/issue rule for PC on page 4 of the Product dictionary. You need to create the rule in LIS Shared Dictionaries, Rule Dictionary and create a BB assignmnet rule type. Go to Atlas and enter "Lab Rules" and you should be directed to the Rules Catalog that provides examples of how to create different types of rules in Meditech for Lab. ;Marker Rule is used to flag patients that require specific blood ;requirements ie, HLA matched platelets, CMV negative blood. ;Marker Rule resides in the Product Dictionary. ;Marker applied to PATIENT must be the same marker applied to PRODUCT. ; [f bpt unit mkrs comp]^X, IF{X "Pt marker not on unit: "_X_" OK? "^X, [f basn yes/no](X); [f basn ok]};

I thank you as well for posting. I had a spare alarm already in place from when my built-in got fried a few years ago (I never removed them after fixing the built-in). So I changed it from 1.5 to 2.5, revised my P&P and tested it today. Oh yeah, AABB is coming tomorrow.

OK - I'm going to be controversial. The baby is RhD negative using several reliable anti-D reagents that are known to pick up all but the weakest Weak D antigens, and the baby has a positive DAT. Why are you even considering giving RhoGam? The baby is RhDnegative. No need to do a Kleihauer (unless the Doc wants to check for fetal bleed, but nothing to do with the Rh group) So the financial equation is not between how much does RhoGam cost compared to EGA (and what about the technician's time) or Kleihauer but the cost of RhoGam and/or EGA and/or Kleihauer against having a good system in the first place. And are you going to do an adsorption/elution on each one as well just to make sure it's not a Del? Why not a genotype? It would be more accurate? (Although soon, that probably WILL be the case in Europe - pre-natally - using fetal DNA extracted from maternal plasma. Some countries already doing that)

John V, AABB Standard 3.7 for Alarm Systems reads "Storage devices for blood, blood components, tissue, and derivatives shall have alarms...". RhIG is a derivative, so this is a valid finding.