R1R2

Quality Guy, Scenario 1 happens frequently after reagent inventory or after new shipments are added to the fridge. I would imagine that a lot of labs have these types of temp issues. Sometimes they are unavoidable. Scenario 2 hasn't happened since we installed an electronic temp monitoring system but for hospitals that still take manual temps, this could be a possibility. What does your policy say about checking reagents after unacceptable storage conditions? Do you perform a visual check or do you qc all the reagents stored in the fridge or do you do something else? Thanks for your input.

I agree with your logic!

Definitely Jsa!

Before switching to immediate spin crossmatch from AHG crossmatch on everyone, we would find many of those antibodies, that you mentioned, Dan87. We did not blink when we switched to immediate spin (and then electronic (sorry Malcolm) crossmatch). We are a large urban hospital system with many sicklers. We knew that we would miss the occasional low freq ab that could not be detected on the screening cells. (One note, many of our sicklers require full AHG crossmatch due to history of clinically significant antibody, but they would get IS XM if they qualified) I have not seen one incident of a HTR due to the antibodies you mentioned. I am sure that they occur, but rarely, and not a reason to stick with AHG XM for all, IMO. One document that I love to review is the FDA report on fatalities due to transfusion. It is always a good read. https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/TransfusionDonationFatalities/

Amazing! Just amazing! And not in a good way.

How do you confirm the accuracy or quality of material before use when temps are out of range? 2 scenarios: 1. Reagent range temp is 2-8C. Fridge temp increases to 10 C for 30 minutes during inventory before returning to acceptable range. 2. Reagent range temp is 2-8C. Fridge temp increases to 22 C for 2 hours before discovery and reagents moved to another fridge. COM.30800 Temperature Corrective Action There is evidence of corrective action taken if acceptable temperature ranges for temperature-dependent equipment and environmental temperatures are exceeded, including evaluation of contents of refrigerators and freezers for adverse effects. NOTE: If acceptable temperature ranges are exceeded, stored reagents, controls, calibrators, etc. must be checked to confirm the accuracy or quality of the material before use and records maintained. The check should follow a defined procedure.

Would be very interested to know what antibodies were detected.

I used to see hemolysis all the time when using clotted specimens (10 years) but I have never seen it when using EDTA (10 years).

Nope.

Found early mornings and evenings are best. A martini in hand doesn't hurt either.

No, not that I am aware

Hi all, Our GEM4000 low HGB AMR is 6.5 based on the lowest PVP HGB level. IL states that the instrument can measure HGBs as low as 3. Does anyone measure lower than 6.5 and what calibrator are you using?

Hi all, Our GEM4000 low HGB AMR is 6.5 based on the lowest PVP HGB level. IL states that the instrument can measure HGBs as low as 3. Does anyone measure lower than 6.5 and what calibrator are you using?

When I first started as supervisor, the BB used to combine in the lab, do all the computer steps and change expiration to 24 hours, but after wasting a returned pooled double bag apheresis platelet because of a reduced expiration, I rethought our process and switched to combining at the bedside. When we changed our process we included a note with each double bag apheresis explaining the "new product" and how to open the clamps and combine before the start of the transfusion. Nursing was very accepting. A couple of good things happened in the lab - we eliminated several computer steps, i.e. tech time, eliminated unnecessary waste of products and reduced the chance of making FDA reportable errors due to labeling and expiration date changes (history of a couple BPDRs/year from pooling apheresis platelets).

Nurse combines at transfusion time.

I have seen this so many times. We used the Gamma Elukit. On a related note - while doing an annual competency assessment on an experienced tech, it was noted that she prepared the Elukit last wash with saline!!!! Once corrected and all staff re-educated I noticed that the numbers of unexplained anti Ks in eluate decreased.

Is it possible to move contents of one tank to the others, let LN2 dissipate and then move an empty tank?

if you are testing the exact same analytes with the exact same survey no, but you can order a verification survey for the cancer center or order a survey from another company. Either way, these suggestions are optional and are not a regulatory requirement. Remember that you do comparison studies 2x/year if you are concerned about not running a survey.

Different issues if the Cancer Center is on the same or different CLIA as the lab. Can you be more specific?

in the old days I think it was called "clot to hold"

I should add that most validation policies require that the span of reactions be tested (in this case negative, w+ to 4+) as well as testing reactions per well so you should pick your samples wisely. Don't forget that this instrument has been through rigorous testing to pass FDA approval so no need to reinvent the wheel IMO.

Our validation policy suggests for beta site - 20 points for precision and 40 for method comparison.

Titers are time consuming as SMILLER stated. Also, some of my dedicated BB staff had difficulty with titers when we first brought them in. It did get better but if I had my druthers I would let a reference lab handle them.

Are there any other reasons for the drop in hemoglobin? It would not hurt to perform an eluate and be sure to include running some B cells with the eluate. If you have any remainder of the A pheresis, you may want to perform an anti B titer too. Keep us posted.

agree with Malcolm