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Darren

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Darren last won the day on November 20 2018

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    Clinical Laboratory Scientist

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  1. I would think that if that were the case it should say: "Once the product vials are opened, the reagent's performance characteristics are maintained for seven days when stored at recommended temperatures and within its original vial. Do not use this product after seven days of being opening."
  2. This is the problem with peer to peer inspections, I interpret it differently and unfortunately the wording is less precise than previously and open for interpretation. Interpretation, though well-informed, is still opinion. The new line doesn't say that the performance characteristics end or that it cannot be used after seven days. It would seem that a lab could validate them for longer use as long as they did a decent study and include things like examining for hemolysis, reactivity strength over time, etc. So far I can't get the updated PDF from the Quotient website.
  3. I recently received a notice that Quotient has updated the IFU for the AlbaQ's. They removed the line: "Once opened, vials can be used for seven days." They replaced it with: "Once the product vials are opened, the reagent's performance characteristics are maintained for seven days when stored at recommended temperatures within its original vial." To me this opens up the possibility of using them until the reagent expiration date. Of course that would depend on a validation study. I've kept old ones around and they seem to never lose their reactivity. Even to the point that they rarely suffer from lowering grades as they age. Thoughts?
  4. We very rarely resort to running manual gel so I gave up doing the controls on it daily a few years ago. We run them if the Vision is down, but of those rare times we have to run manual stuff the reagents have been QCd on the Vision already that day. It makes me wonder if you took the reagents off of the machine to use manually in that case, could you then just do some abbreviated QC. All you'd really be checking is the pipette, incubator, and centrifuge (which work as expected 99.9999% of the time). So I wonder if just running a positive and negative DAT would suffice.
  5. I "review" everything. I put it in quotes because it's actually done automatically thanks to my girlfriend being a SQL report writer in IT. If you have a SQL writer you can have them whip up a report that does the reviews for you and you just stamp it reviewed and take whatever corrective actions you need. I guess this also assumes that your facility is using a TAR system for nursing to enter vitals and whatnot. It's really baffling why we don't see LIS systems taking more into account the regulating agencies and tailoring their software to it. So many things that are manually looked at could be done in the background.
  6. Why interpret it at all until the extended testing is done? It seems this would create confusion among doctors. "It was negative and then it wasn't!"
  7. Officially we say "females less than 50", cheeky man.
  8. Is that 16% all Rh neg women or just ones with FMH? If it's just FMH patients then the overall number of people developing anti-D would be very low. To conserve Rh negative we often give Rh pos instead to anyone except women in child bearing years and I can think of 1 in the past two or three years that actually made an anti-D. I've seen more anti-E and -K develop than anti-D. Allergies, man. Some people get them on the first dose and some never do after twenty.
  9. Thanks, jazzman. Does anyone here that uses an IR thermometer do daily QC on it? If so, how? Measure room temp and a cold unit?
  10. Are units that are not in a cooler and are taken from a blood bank to patient's room considered storage as well?
  11. It was a bit of a troll question. It seemed to me that if we can't trust the reactions we get in gel then what's the point of using it. As far as I can tell regarding the IFU's Dansket is right. I realize the importance of precision and care being taken in the blood bank, but I think a lot of times we fall victim to an overabundance of undue caution.
  12. Do people call antibody screens negative if they are 1+ or 2+?
  13. If it's positive in gel, we consider them positive. It's been that way at this facility since we went to gel in 2004. We haven't see any complications because of it, but then with our volumes we probably wouldn't. Probably the majority of our daily testing is prenatal type and screen testing from our doctors office. We don't have a huge daily volume though. A dozen separate patients would be about as busy as we'd get. I would say most of our patients are pretty healthy with strong antigen expression. I don't see many below 2+ on them. We only weak D test cord bloods. Isn't it the general statistic that 16% of Rh neg mothers will develop anti-D without RhIgG? You can probably run the numbers on how many you have that test at 1+ and 2+ and then check their results against any DNA testing you've done. You might find that the low the percentage may not be worth the extra fuss. I believe I heard the number of people having just one child is increasing. Huge world of statistics to consider!
  14. Can you give a description of your validation process? I'd like to do away with the #%$^& Ohaus hanging scale we use. I just got some macopharma bags in to get up and running. Thanks.
  15. Does anyone here use poc phlebotomy? We're looking into it and evaluating it now. I've heard of hospitals adding T&S/Xm testing to existing CBC specimens when they use the bedside labeling with patient wristband barcode scanning. In these cases I think they just run a second type on the same specimen if they do EXM. We have EXM validated (for years now), but are not using it yet due to having a timid pathologist. Currently we have a two person verification system when blood bank specimens are collected and banded and we run a second type on that same specimen. Probably not ideal if we go to EXM (eventually . . . hopefully . . . dear god please!). I've heard of other hospitals running a second type on an existing CBC specimen collected at a different time, even from up to a week old. Thoughts?
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