David Saikin

We use BloodLocs.

You can only put interpretations in as Beaker has no "control' functions/truth tables that have been submitted and approved by the FDA. Make certain you validate the time it takes for Beaker to update the BBIS information. I went live w Beaker and another vendors BBIS (as a temp manager). It took over 30 minutes for the interface to interact. I was not privy to that validation, though I was told it was done, I was kept from being able to verify that.

right next to your post is an ad for digitrax temp-check. I do not accept returns after 15 minutes. My study shows rbcs achieve >10C after that amount of time.

Yes

fortunately/unfortunately this scenariooccurred where I was working. Patient w acute gi bleed at a hospital not close to us. Transfused 20 group B plasmas and 16 group B rbcs. Patient under control and transferred to our hospital. On day 2 we gave him 2 B plasmas. On day 4 we had a request for 2 rbcs. Patient still typed as B+ with a lot of unagglutinated cells in the front type. Those cells typed as O=. The patient's bili went from 2 to 31 in the next 16 hrs and they expired. Turns out the patient was a known O=. ER doc drew bloods and put in pocket; labelled later (obviously mislabelled). BB tech fired as patient was in their file (sent to us because we would not know. We turned the other hospital in to the FDA for the transfusion associated death (as we had not transfused any rbcs). this is a scary story

Decades ago I worked w a tech who worked w Peter at NYBC. I had always looked under the scope (as that was how I was trained). I'd ask her to look at 2 or 3 or 4 cells stuck together microscopically. Her comment was always, "If you want to call that positive go ahead, but I'd call it negative." High anxiety to give up the scope but I did.

only a reading lamp.

i've used it for ABHHDN for decades.

Sounds reasonable to me. As long as you have defined what the acceptable comparisons are I would say you are fine.

We all have these transfusion event stories. Rec'd a phone call in the middle of the night years ago. 3 out of 4 units were transfused to the incorrect patient. Fortunately both pts were O Pos. We used Typenex numbers. BB tech switched the 2 patients; could only be resolved at the bedside. 2u transfused in dialysis. When asked about the "red" numbers I was told that they no longer checked them as they always matched. I informed them that they gave 2u the day before to the incorrect patient.

Yes, but DVI donors need to be typed as D+. Donors are not patients.

Me too. I have a DVI patient here (has anti-D and anti-Jka)

The donor could be a DVI but the blood center is testing using an anti-D that does not detect that epitope (usually the hospital transfusion service doesn't want to find that person as Rh+ but the donor center does). OR, the blood center has typed the incorrect unit.

i used to use Simmler's kits. Worked well. CAP actually has a kodachrome of a KB stain as part of the FMH survey. You could have all your techs give you a result using that and then wait to see what the consensus is. When we did these here i had all techs read slides after we had reported.

I verify the accuracy of the probe thermometers in all my environmental storage devices and do not keep an external thermometer in any. Have not been cited in 20+ years, including FDA licensure inspections.

I think that as long as your reference thermometer is NIST traceable for accuracy you should be able to do what you are planning. If i was inspecting I would want to see that your reference has demonstrated accuracy (NIST traceable).

I believe most vendors do the training for Nursing staff.

I would think that titers would be relatively constant across different platforms, but then again I am a blood banker. How do you get a titer of 12 (guess I'm used to serial dilutions 1:2)

I looked at Quotient and Hemobioscience. Could not find that kit.

You must be registered or licensed, yes?

cold agglutinins (you did say "a lot of antibody screens tend to be positive in all screening cells."

make certain you validate the time it takes to populate in EPIC (I temp managed a facility that went live with EPIC and HCLL on the same day. After some investigation why Nursing couldn't find units when we called that they were available for transfusion, it turned out that it took about 30 minutes for EPIC to receive and make available data from HCLL). I was not privy to validations though I did have to approve them (seemed kind of bizarre). I do not know the outcome as my tenure was up before it was resolved - I wanted to bring the FDA in. Facility chose to bring in some folks higher up in the food chain to help resolve this issue.

I would mark it NA as I don't feel BB performs any "analytical" type of testing. That question is more in line w Chemistry or Hematology which generate numbers, not interpretive data.

Me too John

I think this is something that you need to think about what you want. You can set up the validation titers (you should document the "how" for both tubes and gel). It is once you get your results you will have to determine that a) you like them and b) you'll have to document how you will notify your users that you have changed. I think that you should continue with tube titers on any patient you are currently doing titers on (don't change in the middle). Most of your validation plan will deal with how you are running these tests; and then how you will disseminate to your users. Not much help - most of this is dependent on your procedures.