SMILLER

On June 15, 2018, following an investigation by the U.S. Attorney's Office in San Francisco that lasted more than two years, a federal grand jury indicted Holmes and former Theranos chief operating officer and president Ramesh "Sunny" Balwani on nine counts of wire fraud and two counts of conspiracy to commit wire fraud. Prosecutors allege that Holmes and Balwani engaged in two criminal schemes, one to defraud investors, the other to defraud doctors and patients.[7][56] After the indictment was issued, Holmes stepped down as CEO of Theranos but remained chairperson of the board.[8] The case is proceeding in the U.S. District Court in San Jose. Holmes and Balwani have pleaded not guilty.[57] They face up to 20 years in prison.[58]

I don't think you can do much "assuming" like this in the BB, much less healthcare in general. A unexpected positive reverse cell is most likely due to something innocuous, but it could be, at the least, a sign of an ABO subgroup or whatever. In any case, you would want it all documented for the next time you see that patient. Scott

I just answered this question. My Score FAIL

If the patient has been transfused or pregnant in the last 3 mos, one has to r/i r/o significant atypical antibodies every three days. This going to involve more than a screen. Scott

Albumin. Scott

In general, here the anesthesiologist is responsible for transfusions during major surgeries. A tech or nurse would do the documentation in OR. When all areas used transfusion forms that were attached to the units, regardless of where they were transfused, copies of those tags were sent back to the BB. We reviewed them for completeness and anythin g else that may have been missed, such as a raise in temp, and then sent the reports back to the managers in charge of those associates for comments and corrections. I believe the deficiency statistics were reported to the transfusion committee. Now the transfusion vitals, etc. are put right on the electronic chart. Deficiencies are almost non-existent as the system alerts the person entering data when something is amiss. Scott

LOL! We would send it to our reference lab! We have other things to do here... Scott

For the simular case we had, all we did extra was a 30 min, 37 C settle test (unspun) to resolve the positive reverse A cells (A patient). We did not see a point in doing anything else--the gel screen was negative. Scott

One reference I read puts the prevalence of EDTA-clump-able platelets at less than 0.2% in hospitalized patients and only 0.1% in the general population. It's a purely in vitro phenomenon so I would guess that donation processing does not include screening for it, as it would have no in vivo significance. Interesting question though. Scott https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5538042/

Trouble with the reverse A cells? We had a similar case recently. Scott

Yikes! I would hope that your facility's patient and specimen ID policies have improved since those days! Scott

I am not sure that there is a fool-proof way to detect WBIT, but checking the ABO at the bedside will, at the least, help avoid death by ABO incompatibility, even if the T&S testing was done on a different patient. Scott

I think you may mean "correct nomenclature are vital to universal understanding". (Alternatively, one might say "a correct nomenclature is..." ; as the noun nomenclature can be either singular or plural.) Scott

I suggest you contact other facilities in your area and see what they have been doing. You will want to know how they are satisfying any regulatory requirements with whatever method they use. Scott

I think the idea that there is a odd antigen on the reverse A1 cells that is reacting with patient IgM is probably the case here. In fact, come to think of it, I believe we have come across this sort of thing has happened before. (The previous ABO typing was actually done 6 months ago at another hospital). Scott

Once a day, along with other daily reagent QC, we incubate at 37C for 15 minutes our anti-D reagent with D-negative QC cells. We wash 3 times and test with anti-IgG. Then check with Coombs control cells. This simulates what we do with a tube screen. If the reactions are negative and positive respectively, we say that that validates "QC" for the cell-washer. JCAHO has not had a problem with this. Scott

We do see cold anti-Ms (or colds that mimic anti-M) causing trouble with gel often enough -- they have to be resolved in tube, often with the pre-warming, We are unlikely to do any further testing to identify what kind of cold antibody this is. Its just unusual to get a patient with a strong cold agglutinin that does not interfere with our manual gel screen testing. We are not complaining! The patient has been transfused a few times with no problems. Scott

Reverse O cells are negative with this patient's plasma. I should also note that the (tube) poly DAT was about a 1 or 2+, with a negative anti-IgG. We don't do anti-compliment testing. Scott

We have performed two T&S s on a 79 year-old male who is in for a GI bleed. He is on record as a A pos with no previous difficulties in testing. But for both times we have done and ABO/Rh, his reverse A1 cells are giving a 2 or 3+ reaction (in tube). Not due to rouleaux. We have to run a 60 minute, 37C settle test in order to get a negative reaction. He is positive with anti-A1 lectin. His CBCs have to be warmed in order to get a good RBC. Cold agglutinin? But the gel screen comes out negative - no interference. That seems curious for what is almost certainly a cold agglutinin. Just wondered what is going on here. IgM antibody to a miscellaneous antigen? Scott

The problem is not just that the unit is or is not within particular temperature range before being put back into use, but rather the unit has not been monitored while not in the care of the blood bank. A unit sent to, say. OR in a cooler, may have been "checked" when it got into the theater -- and left for a time on the counter (maybe next to an incubator!) -- returned in the cooler on ice you will never know if it was kept at a proper temp all that time. And how do you really "validate" a unit's potential for a "detrimental" effect? Transfuse various units left on a counter for different times and see which patients have a bad outcome? Scott

Drugs?

Right, and I would not even go so far as to say that a CAP or JCAHO inspection is equivalent (as far as how stringent it is) compared to an AABB injspection. Just that any CLIA accredited agencies are going to be using standards that are derived from AABB guidelines. In fact, the FDA does some extra stuff beyond AABB for things like tissue tracking. Scott

In the US, all accrediting agencies must satisfy CLIA, and Blood Bank regs are based on AABB standards. So AABB standards are already in use by JCAHO, CAP, etc. Scott

If one is doing a DAT in order to determine the status of a possible acute transfusion reaction, then the presence of antibodies on donor cells is the concern. There may be some use in incubation here to enhance uptake, but I have never heard of it being part of anyone's transfusion work-up procedure. Scott

We haven't for some time. It always was a crappy test for so many reasons. For general platelet function, we have a PFA-100 , and for P2Y12 (e.g. Plavix) and aspirin, we use a Verify Now (Accriva). Scott