carolyn swickard

We have been with Joint Comm (TJC) for 2 years now. They said that with their standards, the Lab Medical Director has to sign all new and revised Blood Bank procedures and has to do the SOP review every year too, for Blood Bank only. The other depts are delegated to other pathologists and lab supervisors, but not Blood Bank. They would not even accept the pathologist who has oversight of the Blood Bank because she is not the acting Medical Director. That was a change from what we had been doing with CAP. I also have the pathologist with responsibility over Blood Bank, review and sign off on my QC work at the end of each month. The FDA said it had to be someone other than me and they were not happy with another supervisor either, so she wound up with it. Joint (TJC) seems happy with that SOP too.

Just a thought - I've noticed here that if I spin the indicator cells in the cell washer (after washing), that the pos ct is weaker than when I take the tubes out and spin them in my bench centrifuge.

Was there any movement between plastic or glass tubes - you weren't clear on that. What is your level of static electricity like? Do all of the techs wear gloves and jackets or only some? Just a couple of guesses. We have such high static levels that we had to get Ionmasters in place in order to get reagents to "drop" in the tubes. Have your humidity levels been bouncing around? We have some problems with "sticking to the tubes", but it tends to be only with PEG manual tube testing. Doesn't sound like that is your problem. Good luck.

We had to recently update and revamp our too - same reason. Hope this helps. Our procedure is specific for Meditech, but most of it is usable. 61-Newborn Exchange Transfusion - 2.doc 67-Transfusion of the Neonatal Recipient (under 4 months) (2).doc Exchange Transfusions RBC Unit Worksheet.doc

If you are talking about weak backtyping from an analyzer like the Echo, why not just replicate routine testing for your backup method? We just put 2 drops of plasma in an A1 cells tube and 2 drops in a B cell tube, spin and read at RT, just like we would do on a manual tube testing Group. The Echo, in particular, can give weak backtyping reactions because it shakes hard and for a set time limit. It can not respond as you do manually by backing off on shaking a patient if you notice a weak reaction. That 1 hour method you mentioned is just asking for trouble with colds and rouleaux (if using plasma). I would think a change in method could be encouraged. Good Luck

Is it an FDA regualtion? i know they won't allow any lines, arrows, dittos, whiteout, etc. Our blood supplier had to resubmit everything for their irradiator validation because they had used arrows and we can't use them in our irradiation log which is inspected by the FDA. Would that make it cGMP standards?

Isn't this the same as that Super DAT that has been discussd before? I couldn't find the thread before when I searched under "Super DAT", does anyone else know how to find it?

Yes - we had to write a whole "unidentified patient protocol" that defined WHEN and WHERE Admissions could mess with the pt name during a Trauma. It is very specific, but we have trouble getting Admissions to follow it because they don't get to use it very much here any more and training suffers. But it did keep them from changing the name in the middle of an event - even worse, they would change the Medical Record # too if they found an older record. The protocol says they can't do those changes until the patient is stable. If we have used a trauma name (defined by the Blood Bank wristband number) they must keep the number with the name until the pt is stable, dead or transferred, even though they can ADD the pt name into the pt name field if they learn it. That was important to other people in the hospital who needed to know who we had here when pt families started calling, etc.

Thank you so much Malcolm.

We have just started with a difficult sickle cell patient too. We have very few here and I had tons of questions. Just found this thread and it answered a lot of them - thanks everyone. But still - a few more questions - 1. His home hospital says he has an Anti-Goa that is still detectable in his serum. We are coombs crossmatching E neg, C neg, K neg units for him and hope to avoid the Goa as long as his serum keeps a high enough titer. But, is there anything else we can do to avoid this antigen? What little I can find on Goa indicates that it is associated with a partial D - is that the case or did I misunderstand everything? If we use Rh negative units to avoid the C and the E, will we avoid the Goa too??? 2. I did not notice that anyone mentioned washing the cells routinely. His home hospital washes all of their units for their sickle cell transfusions. Does any one know the justification for washing? We can't wash here and can't get it from our supplier without getting into unlicensed products (across statelines) so would really like to know if we are going to hurt him. 3. At his home hospital, he actually gets RBC pheresis along with his transfusions. Does anyone know anything about that? What it is for, how it helps? Unfortunately, we can't do that either - no hospital in the region does pheresis for RBCs, though we have one that does plasma pheresis procedures. 4. Am I understanding your comments correctly that if the pt is Fya neg and Fyb neg and forms an Anti Fy3, that you can give Fya neg units and that is suffficient??? Our pt can only form an Anti-Fya since he is positive for Fyb, but I wasn't sure I was getting that Anti-Fy3 problem correct and I know that a Fya neg, Fyb neg phenotyping is much more common in some populations. Any help with these questions would be deeply appreciated.

I always reccomend doing the ECHO panel too with any reactivity on the RS3 screen. I think you should give the ECHO the chance to show you what it is trying to detect. Then a procedure like the one mollyredone recommened for gel works well for solid phase too. Solid phase crossmatches are good too, but I have the feeling that they are not quite as sensitive as the screen and panel though, because they are a fresh blood monolayer, not a manufactured layer of dry, lysed cells. Doesn't hurt to do them though.

The oddballs are hard. I get as much data on the patient and the transfusion as I can - (diagnosis, when transfused, how many other units, etc) and then take the recall/withdrawal to the Pathologist in charge of Transfusion. We look the thing over together and decide on what to do. Anything with a chance of an infection - we notify; most of the rest of the stuff we don't, but there is no way to anticipate all of the oddballs in a single SOP. When there has been followup testing that eliminates any window periods - the decision to not notify is easier. But many times, since the donor can't donate again and the blood distributors don't just retest these folks - you just have to make a hard call. My pathologists really doesn't like the ones like that and feels that the blood distributors really should retest a donor that they are going to send out a recall/withdrawal notice on. Fresh testing data would be the best answer for everyone. I did like the one answer where they always send a copy of the notice to the attending (if findable) and a letter saying "Call us" - might be a better way to handle these.

Ok, not WinRho D, but what about a large dose of non-specific immunoglobin? Pharmacy might have data.

Oh wonderful - thanks for all the info and the headsup. Always better to have some warning.

Try using anti-K1 and anti-K2! I always tell the students that is what they should be called - but don't expect me to be able to remember it. Anti-Big K and anti-little k frequently make more sense to students because of the similarity to the Rh antigens terminology.

The CAP survey for Antibody Titers has been following the different methodologies for some time. The result bell curves for gel is always higher than any tube methodology using the Uniform Procedure CAP recommends (The titer is run in saline with no enhancement medias). If you switch to gel you will need to let your physicians know why the results are higher.

We used the CAP Automated survey for several years and then had to switch to API (costs). It hemolyses very quickly and tended to give questionable results (questions marks) to the point we finally asked to go back to CAP for this survey. We still use API for the manual survey and YES!!!!! they still send everything at once and expect it back within markedly less time that the CAP survey requires. With our current depressed staffing, it is very difficult to get that thing rotated through, finished and back out the door. As you can probably tell - i am NOT an API fan. You also don't get the nice workups that CAP gives for Blood Bank results - especially the work they are trying to do to standardize the Fetal Stain results and the subsequent amount of RHIG to be given.

We still do the manual checks quarterly. I had an inspector voice the opinion "that electronic checks were fine for the other months, but should be manually rechecked at least once a quarter." That was some time ago (sigh!!) and electronic tests were newer, but current inspectors are happy with our system, so hadn't thought to change it.

Yeah - especially that FDA approval part! Same goes for all the hype for viral inactivation strategies that call for treating the blood or adding something to it - I'm sure the FDA will jump right on approving those procedures. What about artificial blood too? Still don't have that one and the last US company really working on it seems to have gone down and out.

Given the extreme sensitivity of the ECHO screens - we call them negative if the instrument calls them negative. Only very rarely now do we see one the instrument calls negative that visually looks "somewhat positive", especially since Immucor has their Solid Phase problems fixed again. Any samples that we have any questions on, we also take to PEG in tubes - not much other choice. If you are used to Solid Phase manual testing, you will think the ECHO looks a little "hazy" around the dots, but that just seems to be the nature of the test on this platform. We have been using an ECHO for 5 years now and are doing very well with it. Antibody panels on the ECHO are the only way to even replicate some of these weak positives if you want to have some idea of what the instrument is trying to detect. Tube testing and manual solid phase testing just don't show them. Most of the time they are just some non-specific "junk" and the only thing you can do is coombs crossmatch units for the pt. That may sound like too little work, but understand, the ECHO is probably the most sensitive platform out there and it will find stuff at the very edge of detectability. Good luck.

We have weighed the RBCs for a long time now. The plasma products all have an approx volume on them, but not all of the RBCs do - and they do vary. The normal range is from 270 - 400 (rare 430) gms. We weigh them on a little postal scale and subtract 50 gms for the approx weight of the bags - which we determined after weighing several returned empties. We weigh them because the RNs needed more help on volumes "in and out" on their pts and their original "guess" of 250 mls was woefully inadequate. Doesn't take long - we just write it on the crossmatch tags. We don't record it in the computer because Meditech doesn't print it out anyway.

I have noticed that Anti-D Series 5 is frequently weaker that Anti-D Series 4 on the ECHO - but I don't think I have seen one that was negative when Series 4 was positive - low bottle or not. I have noticed lately that both Series 4 and 5 are reacting better than they did during the first 2-3 years that we have had this ECHO. I don't know whether that reflects reagent changes or some minor tweak that has happened to the ECHO over time as the field engineers get more familiar with the instrument. The ABORh reaction strenghts are dependent on the "shaking" cycle of the instrument and that could be somewhat individualized in each instrument.

If you are Joint Commission acrredited in the states - they don't seem to like it either. My last inspection was with them and, even with a procedure defining "expired - which and what and how long", the inspector just didn't think it was worthwhile. Tell that to some lab trying to find Little-s or Cw or.....

We receive a unit with pedi-paks attached that we use for our babies. We learned the hard way to irradiate each pedipak as we make it - not the whole unit. Yes - the K+ will build up and may cause problems with a newborn if given several days later, after irradiation of the whole unit. If you can wash all of the units, that might be OK, I really don't know about that. I would think in any case that 28 days would be way too long for the unit. We try to keep our baby unit no more than 14 days.

Have you tried contacting your own hospital's Risk Management Dept for help - they can usually help with risk figures for a "fact" scheet. Also, your hospital's Public Relations officer (if you have something like that), could be approached to put together a reasoned and measured response to the article that the paper would probably be willing to print in the interest of full disclosure. Make sure your facts are correct and verifiable - they may be challenged. Good data can come from UBS, ARC and other distribution networks. And yeah - it takes a multi-million dollar industry to keep blood on the shelves that almost no insurance company or the government are fully reimbursing! Profit margin indeed!