Debbie

I don't have experience with selling off the whole product, but we did collect samples for research ... and we had to amend our donor consent to include a phrase stating that it would be okay for us to use some of the samples collected for research. Rather than obtaining consent for each tube - we just put in a generic clause that it MAY happen and they consent to it. You'd want to do the same thing... as for product handling, not sure I can help with an opinion there...

The numbers you would want to do is TOTALLY dependent on you and your QA. You are validating a process, not a piece of equipment, so you don't want to go down the "per machine" route. You simply want to validate the process, and ensure that each piece of equipment is included in that number. Plasma never fails QC, it's an easy collection, with minimal QC - so you don't need to make the validation extreme. I've seen most people go with the standard "20". Since the new guidance for platelets, and the FDA focus on scan statistics... you may want to consider more along those numbers. Since that's "Guidance" and not "Code" - it's optional... so if you want to go with 20 collections, I think you could make an easy argument for it.

There was a study published in the literature a few years ago about using automation to collect a dRBC (~500 ml of packed RBCs); and that this was MORE therapeutic than just a whole blood. The theory was somewhere along the lines (If I recall correctly...) that the fluid replacement in the procedure reduced the rebound effect of the RBC drain. Might be worth looking in to ... if you have automation as an option!

The regulatory agencies require a "quantitative" method to determine donor qualification for donors who will donate RBCs via automation (i.e. an actual hgb/ hct value). For platelet/ plasma donors... they can use a "qualitative" method (ie CuSO4). Plain and simple - it is not required. It is usually required as a variable to program the instrument, the more accurate, the better the product results. But, it is not required by regulatory agencies. It's not necessarily that they're "cheap"; it's the question of what you do with the information once you get it. The donor had to qualify to donate (12.5% hgb/ 38% hct). A level slightly below that (to account for variations in venous vs. capillary sample, and possible poor technique, is still not going to be enough to make a donor "anemic". That is why the acceptance criteria is as high as it is... a Hct of <38% is not the criteria for a diagnosis of "anemia" A few years ago, there was some regulatory push back that if you get that Hgb/Hct result, and it turns out that the donor did not qualify for the procedure - do you abort the procedure and eat the costs incurred? Many centers then designated the fingerstick as the "test of record" and it doesn't matter what the Hgb/ Hct value were. Many centers chose to "turn off" the full CBC (what you don't know can't hurt you) and just look at the values you need. The Plt count. This same scenario is true for the WBC count. Some centers have lower/ upper limits of acceptable. Some centers don't want to know... I agree with you that it is helpful information as we all know, it's probably a more accurate number to gauge the donor by ... but since we're not collecting RBCs from the donor, there is little harm that we can do. (Even if we are unable to return the RBCs in the equipment due to access issues, the extracorporeal RBC volume of the most commonly used devices is under 100 mLs of RBCs. Still not enough to "do harm".) One other thing to note... VERY FEW blood centers in the US currently have the ability to even get a day-of-donation CBC/ Platelet count... we're going with the best we have with the information we have.

I have to agree with the earlier responses. While it would be ideal for everyone to feel passionate about improving their knowledge and committing to their jobs. We also have a growing number of people who are taking care of children and parents (read the book "When Generations Collide".. it might help you better understand this "new" way of thinking. Calling your employees "these people" might be part of the problem... just a thought). Employees are spending more time commuting to and from work. Time at home with the family becomes more and more precious. Asking them to spend 30 minutes a day "researching" for work - without pay. May truly be too much to ask. Maybe consider giving them a paid lunch if they will read trade magazines while they eat... get creative about ways to do it without busting the budget...

Wow! That is a good one! I'm probably not going to be able to help you with this - as I know nothing about the machine. But one thought is that Citrate does drop the pH of blood, and that could what potentially interacts with the Asahi filter?? Good Luck with that!! It sounds like it might be time for a new apheresis device!!

One blood supplier has opted to test ONLY multiparous female donors. They will test ONCE until the donor reports a change in history of pregnancy/transfusion, then re-test to ensure they aren't positive now. Interestingly enough, when I asked the other day - they have only had 7 donors answer yes to the question about having 4+pregnancies. And, all 7 have tested negative. I haven't talked to a blood center yet that has opted to stop drawing platelets female donors. The risk in getting a platelet that MAY cause a complication is better than the risk of not getting a platelet at all... Due to the transfusion trends in the US, we CAN defer female donors from plasma altogether, but deferring all females would create a crisis in the platelet supply that would be unacceptable. Stay tuned... apheresis platelet vendors are working to get platelet additives through the FDA. Within the next year, all apheresis platelets could be plasma poor products with the platelets suspended in additive rather than plasma and this issue could completely go away. (nearly half of all platelets in EU are this way now!)

We've had a couple staff to interview (more for a larger sign-up mobile), one collection staff member for every 2 WB donors. Then a volunteer to register, and a volunteer at canteen. There are some staff that can manage 3 donors at a time, but it can get tricky and backfire (and when it gets tricky - as mentioned, errors go up). The key is to have a lead worker/ "float" that can step in and help out with VP or reaction issues so that the 2nd donor doesn't get abandoned altogether. The above mention of 1.7 staff/ donor sounds about right to me.

You stated that you use Adsol or CPD-A. Have you ever used AS-3? (I think it's called Optisol or something) Is there a concern about fluid overload with additive units rather than CPD-A?

It is harder for big corporations to give. Think local!! Those "smaller fish" are sometimes more willing to get their name out there. The last survey I saw from America's Blood Centers included a recruitment cost of $20+ per unit. This would include all your posters/ flyers/ advertising, in addition to any donor incentives you may give per donation.

It doesn't even have to be the same number of people working... just use a percentage. This has worked well in the military for years (batallion vs batallion type competitions). In studies, for years, when you ask donors WHY they donate, they will always tell you it's because they want to save a life. Link the donations to the patients where possible!! If they remember they are saving lives, they will be more likely to return. When I worked in a hospital-based blood center, we wrote thank you letters to our donors. ("Thank you for your recent platelet donation, it was vital to the care of a 57 year cancer patient/ 68 year old heart surgery/ 4 day old premature infant...") It took a lot of time, and we couldn't do it everytime (we didn't want them to expect it EVERY time in case the unit expired or broke...) Donors BROUGHT THOSE LETTERS BACK when they donated!! Give your current donors, "extra credits" when they bring in a friend. Have a competition among your current donors as to who can bring in the most new donors. CaridianBCT has all kinds of donor recruitment material that might help you (posters, flyers...), as well as a DVD/Video loop that can be showed in the canteen to help educate your WB donors. Have your staff wear a big badge ("ask me about donating platelets"). Make it easy for your staff to start talking to your WB donors about donating platelets!

Generally, coffee/ doughnuts etc for people who donate comes out of the blood center budget. I have seen LOCAL places donate periodically. Trying to get National (Wendy's, Starbucks..) to donate is tough. It's usually easier to talk to a local store manager. Sometimes these are purchased (sometimes at reduces value), sometimes you bite the bullet for an incentive. Have you considered a donation to the Global Blood Fund? This is a donation to help set up (safe) blood banks in developing countries. Oklahoma Blood Institute (www.obi.org) started this a few months ago, and about 1/3 of their donors now will forgo the "free t-shirt" in order to donate the equivalent amount to the blood fund. It's a way for an altruistic person to double their donation power!!

I have not heard of anything regarding this - have you contacted the vendor? It may be an unrelated "patch" installed on your computer that is interfering with the operation of this software.

How about AB platelets - just eliminate the risk of ANY ABO antibodies altogether. I can't imagine that your blood supplier wouldn't change your standing order to give you one unit of AB platelets for a short period of time. Try another supplier!! Many blood centers out there are willing to do this, let them know that!

Are you asking about the checks to ensure the paperwork is accurate? We do a review of the paperwork prior to shipping the units with the courier, and catch the vast majority of our errors there. After the mobile drive, the paperwork is sent back to the center and all data entries and reviews are usually completed that evening, or first thing in the morning for later evening drives. Later drives, depending on plasma needs, will likely be held and processed in the am. All the paperwork would have been completely reviewed by then...

Heparin is NOT used for general blood collections. It does not drop the pH and buffer the RBCs the way that other anticoagulants do. I believe it would solely be used in cell salvage procedures. ACD-A is the anticoagulant of choice for RBCs collected by automation. CPD, CPD-A is the anticoagulant of choice for RBCs collected by manual methods (the standard stick and bleed into a bag method). The recommendation to check out ICCBBA is a good one - but those are the ACs that are mainly used in the US.

Sebra also makes very great sealers.

The MCS+ has been in use in the US for more than 15 years. I'm not sure that I would invest a lot in it, who knows how long until Haemonetics will retire that piece of equipment. The Trima is smaller than the CS3000, single needle procedures with an average procedure time of around 60-70 minutes. I believe that you will be amazed at how far technology has come since the CS3000 !! The Trima system is an incredible piece of equipment!

I would agree that 24 hours is probably safe. It isn't a question of sterility - because it IS a closed system. The collection devices used to collect apheresis platelets each have their own range of volume/ concentration/ yield that can be stored in one bag. Storing 2 products in one bag, may exceed the range of acceptability and compromise the potency of your product. Unless you know which device collected that product,and the manufacturer recommendations for the storage environment in their platelet bags - you shouldn't store the 2 platelets in one bag for more than 24 hours.