Tympanista

Thank you so much, Carolyn! This will be a tremendous timesaver for me! The form didn't show up in the link, but I shouldn't have too much trouble creating one based on your validation procedure. Thanks again!

I've read a lot of the threads talking about storage vs. transport, so I will definitely be validating them for storage (1-6C). I don't think I'll have any issues meeting that requirement with the Credo bags, so I would rather cover all bases to avoid any arguments during future inspections. Thank you for the advice!

My hospital has a new cancer center opening in a few weeks that is located across the street from the main hospital building. We've chosen the Credo ProMed bags for transporting blood products from the blood bank to the cancer center. Can anyone share a validation plan or procedure that they used when validating new transport containers? I'm going to have less than a week from the time the bags arrive until our cancer center opens (thanks to some poor planning by our purchasing department ), so I would greatly appreciate any help I can get. Thanks so much!

She used to work in document control, so I think she sometimes goes overboard. She said her previous employer recalibrated after changing the batteries, but I know for a fact that my previous employer did not.

Hi everyone, We have several timers in our lab for which the calibrations aren't due until October 2021, per the calibration certificates that came with them from the manufacturer. However, the batteries have all died prematurely. My lab director is under the impression that we would have to recalibrate the timers if we replace the batteries, but we did not do this where I worked previously. It seems like such a waste to buy all new timers every time the batteries die, when the calibrations are still good for over a year. I'm just curious what is being done at other facilities, and if anyone knows of a regulation that states the timers must be recalibrated when the batteries are replaced. I would appreciate any feedback you all have to offer. Thanks.

The Red Cross has specific product codes for thawed convalescent plasma. I believe you should use the corresponding "thawed" code for your convalescent plasma once it is thawed, not the same code you use for regular thawed plasma.

Do you report a titer for the thermal amplitude or just the temperature of reactivity?

The technical manual says to prepare the serial dilutions up to 1:4096. Does anyone take their dilutions out further? Our LIS is currently set up to report up to > 8192, but is there really any clinical significance to reporting a value greater than 4096?

My goal is to convince the physician that the thermal amplitude is the appropriate test for these patients, but some physicians are resistant to change, even when presented with definitive evidence to the contrary.

Thank you for the references. I'm always curious to know what is being done in other labs. We don't currently perform thermal amplitude testing here, so that may end up being a sendout test. I've been tracking all of the cold agglutinin titer orders we've gotten over the past few months and they all seem to be coming from one physician who is ordering them as part of an autoimmune panel for patients with Raynaud's. I will have my Medical Director speak with him after reviewing the reference you provided and we may be able to convince the physician to request thermal amplitude testing along with, or instead of the cold agglutinin titers.

My facility purchased a Helmer UltraCW II cellwasher last summer (prior to my employment here) and I have been told they had a very difficult time during the validation process when trying to produce a clearly delineated cell button during the spin phase. They supposedly contacted Helmer and were told that this particular model does not produce a "good" cell button. I have been trying, unsuccessfully, to perform the annual calibration and no matter how long I spin the tubes I cannot produce a clearly delineated cell button in the negative tubes. Has anyone else had this issue?

I will check to see if that is causing the problem. Thank you for the suggestion.

SMILLER: Thanks for your response. I only spun the tubes for 2 minutes to see if the cell button in the negative tubes would be more clearly delineated than it was at 20 and 25 seconds. Our spin times are set at 20 and 25 seconds, depending on which centrifuge we're using. We have 2 cellwashers and a regular centrifuge that we use in our Blood Bank, and none of them are giving us a good cell button with the negative tubes. I'll have to follow up with our Clinical Engineering staff to find out how often they check the RPMs.

I am revising a 30 year old procedure for centrifuge calibration based on the procedure in the Technical Manual. When you check the tubes to see if "the cell button is clearly delineated and the periphery is sharply defined, not fuzzy" is this for the positive tubes only? I have tried the immediate spin procedure taking the centrifuge time all the way up to 2 minutes and the cell button is still not clearly delineated for the negative tubes. I reviewed the calibration records from the past few years and they have been choosing a centrifuge time of 20 seconds based on the fact that the cell button was not clearly delineated in the negative tubes at 10 and 15 seconds, but it supposedly was at 20 seconds. I really don't believe it has ever been clearly delineated at 20 seconds. That was just the suggested time from the manufacturer, so I think they have been "making it work" each time a calibration was done. Should the cell button be clearly delineated for the negative tubes or should we only be looking for a defined cell button in the positive tubes? My centrifuges meet all of the other criteria in the Technical Manual (clear supernatant, cell button easily re-suspended, etc.) using only a 10 second spin, so I was just curious about how other facilities interpret the procedure.

I agree, Malcolm, I believe the titer is not clinically significant, but I haven't yet convinced the ordering physicians of this. I will save the reference you cited in case I have an opportunity to plead my case. We don't currently perform thermal amplitude testing at my facility, so we would have to send the specimens to a reference lab if we decide to do them. Thank you for your input.