JEMarti

There are differences between the Ortho MTS system and Grifols DG gel system in terms of the amount of LISS found in the RBC reagents and gel cards. Speaking from the Grifols perspective, we have had customers try to validate the use of Ortho RBCs in DG gel cards and frequently these customers observe non-specific agglutination, indicating that there may be some incompatibility between how the reagents and gel cards are formulated.

We had a presentation 3 weeks ago from the manufacturer at a local BB conference. They indicated that the positive Ab Screen can show up within the first day and positive DAT can persist 6 months or more post treatment. They are recommending phenotyping the patients prior to starting DARA therapy and using DTT treated cells for screening and transfusing K negative units to patients who are K neg.

I think the concern here is not regarding gel testing but may be referring to the fact that (as far as I know) all automated analyzers sample their RBCs from the bottom of the specimen tube (for the simple reason that the instrument does not detect where the cell/plasma interface is). Therefore, if the population of RBCs at the bottom of the tube might be skewed toward transfused cells such testing may be erroneous. However, since we do backtypes, unless we have totally diluted out the patient's antibodies we will always be able to catch a discrepancy and resolve it manually.

In Europe Ortho uses glass bead technology. In the US they use gel.

Grifols was the OEM manufacturer for the ProVue and manufactured all of the ProVue instruments for Ortho. Ortho is still allowed to service their ProVue instruments and Grifols has no say as to Ortho's policies regarding the servicing of Instruments sold under the Ortho name. Ortho can continue servicing them until they exhaust their spare parts inventory or until they choose to stop servicing them. Grifols provided spare parts to Ortho until the ending of their contract. The patent situation was that Ortho had license to the patent for gel testing and had blocked both Grifols and Bio-Rad from the US market. When that patent expired in 2012 Ortho lost that protection and now both of these other companies are bringing gel products to the US market. Grifols does have a full line of gel testing instruments which are currently available for sale in the US. Also - Grifols did not make the manual workstation for Ortho. Grifols has their own workstation, which includes an optional automated card reader, and again, they are available in the US already.

The reason that you irradiate HLA matched platelets is because the risk of TAGVHD is greater when you have the likelihood of a close HLA match between donor and recipient. Such a match is unlikely with an RBC from the shelf. As for cytokines, my thinking would be that refrigeration would lead to a greater amount of them being released since WBC's do not fare well in the fridge.

I just arrived here in the Bay Area late last night (my office is here despite my living outside of Chicago). The earthquake was centered in Napa so most of the damage was up there and not really in the Bay Area directly. What I can say is that the good news is that this area is extremely well prepared to deal with this. Building codes mean that most structures are able to withstand the quake and while there are a lot of older buildings that sustain damage and quite a few will have to come down, very few people were seriously injured. When you get to the San Francisco/Oakland area things are pretty much normal. Here is a good local news story: blogs.kqed.org/newsfix/2014/08/24/quake-rolls-through-bay-area

You say that the reference lab screened 9 donors to find 1 compatible. Are you sure that you are talking about HLA antibodies? HLA matched products are not screened on the shelf. You identify a donor and collect them specifically for the recipient. You may luck out and have a product from a matching donor available but you don't go screening units. What you describe sounds like a platelet crossmatch because your patient has platelet antibodies. As for HLA: TAGVHD is caused by having transfused lymphocytes that are a very close HLA match to the recipient mount an immune response against host tissue and the host immune system not being able to successfully recognize the transfused lymphocytes as non-self. Unless you are living in a relatively homogenous community (I recall case reports coming out of Israel and Japan years ago when irradiation was first being employed) this should not be a problem for RBC transfusion with a regular volunteer donor unit. The odds of finding an HLA A,B match in the general US population is far less than 1 in 9. Also WBC's don't fare well in the refrigerator. After about 72 hours at 2-4 degrees they are mostly dead. Most TAGVHD cases from RBC transfusion that you see in the literature are from fresh blood.

As I am no longer working in the lab (having left to go into industry) I will answer... If memory serves, in the lab I left 3 years ago we were paying $245 for a unit of LRBC's from our local supplier. I think that the key factor is where you are located rather than the size of your institution. If there is competition for your hospital's business then your prices will be lower. If there is not then you are pretty much stuck even if you are a large university hospital. With ever increasing consolidation in the industry the likelihood of your being able to shop around for a supplier is slim. I also think that the ability to shop around is worst at the extremes. The small rural hospital is difficult to serve and their usage is low so there is little incentive for a blood center to negotiate on price. Years ago when the ARC made their big price increase many rural hospitals tried to switch but the cost of servicing them was so high that many independent blood centers declined to pick them up. On the other hand, the largest of the university hospitals are so large that many blood centers cannot handle them on their own (exceptions being large networks such as the ARC and UBS). In that case these hospitals have limited choices as to who can service their needs and they too have a limited ability to negotiate on price. Still, there are deals that can be had on the spot market. If you are large enough and can take a large shipment of blood there are some blood centers who will provide very aggressive pricing (and not demand that you take all short dates). If your local supplier imports you can usually see where they are getting their blood from and it may be possible to contact those centers directly. But I would caution that maintaining a good relationship with your local supplier is important. While the institution I worked for did bring in blood from other blood centers from across the country, we made sure that we honored our commitments. Getting a good deal for even a couple hundred units is not worth jeopardizing the relationship you have with the local blood center.

I think the problem you are going to run into is that there simply isn't any documentation or literature surrounding this issue. You might try to point out the fact that there isn't anything written on this issue and that you cannot find any other institution anywhere that does this. You could compare that to the fact that apheresis manufacturers all specify the resting period after collection for their instruments but are silent on resting after any kind of shipment. (this latter is significant since blood centers have satellite centers collecting apheresis platelets and they will not adhere to any protocol requiring resting after shipping them to the main center. And really, unless you have a position of authority to force the issue you might not be able to do anything even though it is pretty unnecessary.

The issue is that you face two separate problems. 1) Sufficiently describing the effects of repeated freeze/thaw cycles on the product and demonstrating that it maintains the clinical utility that is expected. This would lead to defining an expiration based on cumulative thawed time and number of freeze/thaw cycles. 2) you need to identify a tracking mechanism that can ensure that the defined limit on cumulative thawed time/number of freeze/thaw cycles is not exceeded. Which brings us to the 3rd and biggest obstacle: Who has time for all that and does the investment of resources deliver a payoff that is worth it??

Gel cards might seem expensive but they are cheap compared to the antisera. Considering that a drop from a dropper is ~100ul you can cut your antisera costs by 75% per test by using 25ul in a gel card. WIth some antisera running around $1000 per vial the antisera cost is potentially the biggest component of the test. Also, in a past life I did a cost study on antigen typing and in interviewing bench techs discovered (surprise) that techs often rely upon their training for how they do Ag typing and not the package insert(or their SOP). So while the package insert says to use 1 drop and hold the dropper vertically, they will hold the dropper at an angle and use up to 2 drops (such was the way I was trained back in the 80's). That can triple your cost per test really fast. I found that average technique ran somewhere between the package insert and old school training (in truth almost right down the mddle). Gel testing allows you to control antisera usage in a way that tube testing cannot so not only will you use less but your usage will be more predictable. If you want another eye opener, take a vial of antisera and see how many drops you get out of it and how that varies by your technique. Some manufacturers will give you very different results with a variance in technique others less so but there is always a difference. Holding a dropper at an angle can decrease the number of drops/tests per vial by 30% or more. Full disclosure: My current company is not one that sells antisera or blood typing reagents, although I have worked for one of those companies in the past.

The reason the method is not recommended is because the manufacturer does not have sufficient data to support the use and what they are telling you is essentially an off label use for their product. So legally they cannot make an official recommendation but they can tell you what is technically possible and that you need to validate it or QC it yourself. Even then I would be shocked to see them put this into writing. Undoubtedly, this works fine but manufacturers are constrained by regulations as to what they can recommend as the use for their products.

Blood pressure increases with the infusion of fluid. That is not necessarily an improvement especially in patients with CHF. Infusing cells can also increase blood viscosity which is not always beneficial either. But no, one does not transfuse in order to rescussitate a patient's BP.

Most? I have never seen any article claiming that blood transfusion was linked to autoimmune diseases. And if transfused stem cells were causing those symptoms by definition it is not an "auto" immune disease. This article contains some truth but what is there is put in the most alarmist and misleading way. It seems calculated to gain himself notoriety at the expense of others inluding the medical community and patients as well. Sadly, this is not the first newspaper article slamming the blood industry with falsehoods and misrepresentations, and it is unlikely to be the last.

Absolutely! I recall many years ago the night shift generalist getting an plasma order for a baby in the NICU. He thought, "babies in the NICU get O Neg, CMV Neg." Wouldn't you know that we happened to have a unit of FFP in the freezer that was O neg, labeled as CMV neg. The next day the baby had a 4+ DAT. People who are not blood bankers at heart sometimes have a real problem with plasma vs RBC ABO compatibility Depending on who you see in your ER you may choose to put a caveat on the plt >20,000 requirement to not get called for patients with active bleeding.

In my last lab supervisory position we took ~3 months to train, rotating the new staff member to all sections of the lab. All training was done on day shift where we had sufficient staff to check their work. Technically, they were not allowed to do work unsupervised until they were signed off. After they were signed off they would get a competency test consisting of a number of wet samples they had to work up and demonstrate that they could perform basic tests correctly and catch and resolve discrepancies, mf reactions etc. I don't think that there is any magic time limit that is necessary to train people. It really depends on how large and complex your lab is and how much you can do to train them.

You say that she has anti-D, but that the Gel Ficin is reactive with all cells. Does this mean that you got a clean result of Anti-D without Gel? Why did you run a ficin panel? Was there unexplained reactivity that you were trying to account for?

Like Big C, Cw will be found on D positive patients most frequently. Your best bet may be to indicate that you cannot rule out Cw (or report it as a possible Cw) and get a redraw in several months once she no longer has the RhIg in her system.

We are decidedly not QC'ing the user. We do proficiency and competancy testing of our staff for that purpose. If it were QC'ing the staff then we would have every staff member running some sort of QC for every assay they perform evey day. That is not the standard as it is understood today. We are, however, QC'ing the method and not simply the reagent. With that understanding we should be testing both our automated method as well as our manual method regardless of whether or not they share the same reagents.

The best solution is if you can use a checksum tool ( http://en.wikipedia.org/wiki/Checksum )to confirm that the data has transferred correctly then a small sample is sufficient to validate that the records have been transferred properly. 500 should be more than sufficient if the checksum comes out correct.

To be fair many people do a panel in a media that does not render itself easily to doing a panel. Solid state assays are one instance where many labs will follow up a positive screen with a PEG panel. It isn't ideal but that is reality. Best case is you do the panel in Gel. Second best is in PEG. And I will agree with Malcom's comment. Years ago I had a Technical Director who advocated giving crossmatch compatible and if they reacted then next time we would know what it was. It isn't unethical, we simply need to understand the limits of our ability, our technology and our knowledge. If I have a clean crossmatch then I have done the best I can with what I have been given.

You could try to do it by dilution. If you prepare a buffy coat of the bone marrow and then add a full unit of O Neg RBC's and then repeat the buffy coat procedure, you should be able to end up with less than 30cc's of incompatible RBC's (if you are really good or if you add more RBC's you can get it down under 10cc). At that point you will have reduced the number of mismatched red cells below the point that it will cause any significant reaction. If you know how many RBC's you end up with in your buffy coats then you can calculate the volume of RBC's to add back in order to get the desired final volume of incompatible RBC's. It may not be as elegant as a ficoll procedure, but it has the virtue of preserving more of the MNC's. It also does not require any additional equipment, training or skill. We did this on a number of BMT patients years ago with uniform success.

Your biggest hurdle will be moving inventory. If you can get new refrigerators and freezers and have them up and validated then you are ahead of the game. When we moved from the 1st floor to the 5th floor (windows!) we had some new fridges that made the move easy. We also were able to set up benches in the new lab and smoothly transition testing. If you are a trauma center make sure the hospital is planning to go on bypass while the labs move. The last thing you need is an unexpected trauma in the middle of the move. Major surgical cases should be easy to avoid with good communication to the departments you serve. And if you are still in the planning stage the comment about outlets cannot be emphasized too strongly. You never have enough. Also, ports for network printers and terminals. You may not want a printer on a given bench today, but you might later and it is easier to do before you move in.

I'm not aware of any software that currently has a viable link to hospital customer inventory. Some development work has been done in this area and I would look at transfusionmedicinerfid.org to see some of the best work in this area. Companies are still a few years away from having fully developed connections between blood centers and their hospitals. Ultimately any solution will have to work across platforms since a blood center cannot dictate to their entire customer base what software will be used. Mak is used by a number of large, national blood center operations. One can speculate what that means in terms of usability. I know that the ARC has been many years in implementing their system. It may be more of a demonstration of what companies are willing to take on such an enormous task such as the ARC.