Smarty pants

I don't know of a single blood center that DOES have a crash cart (and I have visited MANY in the US). Most who do apheresis will have an epi pen. If you have an RN who could administer an IV, you could have saline in the event that fluid replacement becomes necessary. All have a standard/basic first aid kit, and all staff are CPR certified. There is a risk/ liability that comes with your unlicensed staff administering medications, and how many licensed staff do you have? I believe the US regs require that you have "access" to medical aid; and that need can be met by simply dialing 911.

Both Haemonetics and TerumoBCT sell the additive solutions for their automated RBC products individually (they are added in after the collection). (Fenwal's are pre-attached so, like a blood bag, you'd have to destroy a whole set). You could contact them... you may have to purchase a whole case though - making the destruction of a blood bag probably a cheaper option?

The test you are referring to is, I believe, Verax, distributed by Fenwal. They've gained some ground trying to sell the product as an additional method to ensure patient safety (they have data showing that 1 in 15,000 (or some such) platelet products that tested negative at 24 hours, end up positive at expiration. So, they're trying to drum up some business.) Most of my answers are guesses, but logically based answers. I would imagine that this would be considered just like additional disease testing, but you could probably define it however you want ... and I would be it would be in addition to the initial platelet culture performed by your supplier. I don't know why you'd need to be registered to do an additional test like this - but it is sometimes difficult to apply logic to FDA decisions. So long as you do not enter the product or compromise its sterility - I can't see why your blood supplier wouldn't let you return it for "fresher". Seems like the easiest way to "keep track" of a test that needs to be performed every 24 hours - would be to start out your day performing the test on all products in your inventory so that you're then covered until the next morning. Sort of like morning QC. Tubing sealers aren't really all that expensive (a couple grand) and you'd probably find that there are other things you never realized you could use them for ??? All that said ... I wouldn't start to panic just yet. Fenwal has been trying to gain momentum in the industry for a couple of years, and I don't see anything changing overnight just yet. It could still happen, FDA is very concerned with bacterial contamination ... but I think it will still take some time.

ASI (American Scientific) makes medical grade heating pads. They are large, and blue vinyl (easily wiped), and generally sit from tailbone to shoulder on the donor bed. I like them because they are warm and really help. I don't like them because they're too big to cover an arm (the part that's the coldest), and if the donor has a reaction... it's tough to remove the heat source quick enough. Rice (corn) bags and warm blankets may be a better option.

I don't believe there is any reason to defer a donor for that test result alone. I think the question that needs to follow would be if the donor would be considered to be "under a doctor's care". If they are under a doctor's care to work up some sort of condition... I would defer the donor until their doctor releases them with a clean bill of health.

Back when I worked in the donor room, we would periodically collect a granulocyte (we had a list of frequent platelet donors we called from... they had to have donated platelets in the past month to be eligible). We did the exact protocol you're describing for your walking donors. Tested AFTER transfusion There was an additional informed consent that was required (in addition to the standard risk of transfusion), so the perscribing MD and patient were both aware that we had done all we could to verbally screen the donor, but that in this urgent case, the blood product was being transfused untested. We never had one come up positive for anything after the fact. I think it would somewhat cover you in a court of law ...

Liz - I assume you're talking about TPE for treatment of TTP? Blood warmers are an option, but not necessary ... put enough blankets on the patient and they'll do quite well with an infusion of about 4L of plasma over 90 minutes time.

We do brown bag sessions once a week where MTs and Residents discuss an interesting case for the week. Usually presented by the resident who cared for the patient (donor). The MTs really enjoy going to these... they are under an hour, and everyone eats lunch at the same time. We've done it this way for years! (An email is sent early in the week with the topic so interested parties know to plan on it - may be Donor Center related, Transfusion Services, or Lab related)

Terumo also makes one that is simple, cost effective and the hour-glass shaped rollers help to keep the tubing ON the roller with much less effort (less carpal tunnel issues). Not sure of the pricing, but I think it's pretty close to the Fenwal strippers - and a MUCH better product!

I can't see a reason why you would defer the donor for any period of time. You would defer a donor after an iron injection to protect the donor. It's not a risk to the patient... but if you're treating a patient for anemia (the only reason for an iron injection I can think of) it wouldn't make sense to remove blood and "undo" your work. As for your patient fatality from the B-12 injection. SHOCKING!! But, let's point out it was the injection practice that caused the fatality, not the B-12. If you're concerned, you could defer for 24 hours to make sure there are no signs/symptoms of infection from the injection.

Are you in the US?? There is a whole Draft Guidance document for automated RBCs from January 2001. (http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080764.pdf Basically, the average dose needs to be 60 gm Hgb (non leukoreduced) or 180 mls of absolute RBC mass. So most blood centers in the US are targeting 200 for the RBC mass - which is a 250 mL total product volume (to ensure they are well above that 180). 230mLs seems a bit excessive... unless you're talking about the total product volume, then you may have QC issues. Trima relies on a reasonably accurate fingerstick. It is well documented that fingersticks tend to be off by 2-3 points. If your techs do not use proper techniques and you're off by more than that - you may struggle with low doses... you'll want to keep an eye on that and adjust as needed to ensure you meet all requirements. If your using the new software/ kits to collect leukoreduced RBCs - the standards are a bit lower, and most US customers are targeting 170-180 mLs for the RBCs. (Which makes your 230 ml product volume make more sense... if that's what you're doing. 180 ml RBC mass would be about a 225 ml product volume) Trima allows for 100% fluid balance saline replacement, again, most US centers are doing this... Trima will calculate the volume taken from the donor and replace that volume in ACDA+ Saline. It's not required by Trima, nor any regulatory agency ... but donors tend to feel better, so why not? If the link to the Guidance document above doesn't work for you . just go to www.fda.gov and type "RBC apheresis" in the search box and it should pop up pretty quickly for you. www.aabb.org would have similar standards. Good Luck!

US Regulations would consider a donor eligible with a Hgb of at least 12.5, Hct of at least 38%. You can meet one and not the other (i.e. hgb 12.5, Hct 37.8) .... you DO however need to specify in your procedures WHICH value you will use as your "test of record". You cannot pick and choose the value you want to use in order to qualify the donor. Once you pick one, that is really the only one you need to document and track.

Lyla_n - You should be able to contact your local CaridianBCT rep for answers to the questions you are asking. I have a sample SOP for the most recent software, version 6.0, which has a pre-attache leukoreduction filter... I'm assuming that you're using that??? I can't figure out how to attach to this, so if you post your email, I will email it to you. To answer your questions - it is NOT necessary to have saline replacement, however I don't know anyone who doesn't do that. The donors just feel better, so why not? Yes, you do need to use additive solution. In the US, the Trima Accel is cleared for use with AS-3, it is also available from CaridianBCT (and other places). I'm not sure if/what it is cleared for in other world areas if you're not in the US.

All of that aside.... we had a Jehovah's Witness patient all ready for a plasma exchange using 100% saline as replacement... when his religious leader walked into his room and told him he would absolutely go to hell if his blood left his body and returned. I believe there is a lot (A LOT!) of variability in how they choose to obey this commandment, that it really needs to be managed on a case by case basis.

While CMV is in the WBCs, and it would make perfectly logical sense that pre-storage leukoreduced blood could be considered CMV negative, he hasn't found studies proving that fact that meet his strict standards.... we continue treating CMV+ blood products as CMV+ regardless of their leukoreduction standards.

You will want to review the regs. There are some very specific requirements for validation QC of split products in the US. Also the manufacturer's recommendations. For example, CaridianBCT (Spectra/ Trima) manufacturing specs state that the products be in their final storage environment within 24 hours of collection. I believe most blood centers will split the two products at the time they get the bacterial sample (usually 24 hours). You will need to validate your ability to split products by demonstrating that you can get an 'equivalent' yield. (i.e. a 6.4 product will yield you at least 2 - 3.0s). Once validated, I believe you do not need to test each individual product for yield - just the "mother" bag for concentration and then weigh them to determine the yield. Most centers also set a "lab minimum" before they will split (like a 6.4 for a DPP, and a 9.6 for a TPP). Your apheresis device manufacturer should be able to give you some guidance on this. Most centers have been doing split products for a while now.

I haven't heard of this, and can't imagine a filter small enough to remove the antibodies. Even a dialyzer doesn't remove IgG. I wonder if they used a platelet filter to remove the WBCs?? (which doesn't really make sense either, cuz they don't survive the freezer) Fascinating...

Just wanted to let you all know that a debate was started with my Simpsons-loving colleague. When I tested him, his response was "Double O negative" (not the "AB double negative" posted here). When I let him know how disappointed in him I was with his 'alleged' knowledge of the Simpsons. He then quoted the episode and scenario... followed by links... therefore, I must clear up the confusion here... Bart Simpson is NOT "AB double negative" - he is "Double O negative". Homer is type B Mr Burns is also "Double O negative" There... the confusion about this life changing discussion has now been corrected. Thank you all for a fun discussion!!

Hey JMathis - I applaud your community-mindedness. I have been a regular donor since I started working in blood banking, just never realized the need before that. We need more people in the world like you!! Just for reference... the most recent data (2007) shows that the US National cost to Collect a unit of blood (not to store, transport, or administer (docuementation, IV equipment, nursing time, etc) ... just to get a unit on the shelf of the collection facility) is $220. So your mother's charges of $475 are probably not too far out of line. Most of the blood centers in this country are non profit, and struggling to keep their heads above water. So, I guess my message is to keep on donating!! Keep on spreading the word!! (Some blood centers calculate the cost to bring a donor in the door at $50 per first time donor - so if you can bring your friends to donate, you can help control the costs!!) As I always say, it's the easiest thing you can do to save a life!! No burning buildings, no risky maneuvering around on-coming trains. Just sitting in a chair and relaxing for a bit, PLUS you get juice and cookies for it. Thanks for your post!!