John C. Staley

I don't recall the exact increases and it varied from reagent to reagent. I just remember that both were extreme but Ortho's was more extreme. Some reagents exceeding 200% increase. We stayed with immucor because we have an ABS2000 and dropped what Othro reagents we could.

We sterile dock a syringe set to the apheresis platelets and add 5ml to what ever the physician orders. Our syringe set includes a built in filter so the nurses don't have to filter again. We keep an irradiated, type AB apheresis on hand at all time for NICU and barring special circumstances, any baby needing platelets dips into it.

Ortho notified us of their price increase long before Immucor did and it was even higher than Immucor. There is not a lot you can do short of turning the clock back 30 years and make your own reagents. I still remember making my own reverse cells and check cells. Work out the best deal you can with one of the two suppliers, what else can you do?

We have a young lady (DOB 1978) we have typed 4 times in the last three years. The first D type was 3+, the second 2+ and the third 2+w, two days ago the ABS 2000 typed her as D negative and a manual repeat found a 1+w on IS and 2+ at AHG. The first three types were manual. All typing was done with either series 4 or series 5 monoclonal anti-D from Immucor and the ABS2000 uses both. The only diagnosis we've had on her is pregnant. We've seen no change in our daily QC for the reagents. Any one have any ideas what's going on here? Thanks John

Have you considered, for such patients, skipping the IS and doing the AHG xm?

I just went and counted. There are 8 shelves and we can easily put 20 boxed FFP per shelf (our FFP comes from ARC to give you an idea of the boxes I'm referring to). That would give you a total capacity of around 160 units of FFP.

In addition to all the good things Elaine suggested I will also take the "check list" and note all the applicable SOPs for each question. That way I can get to the references immediately and not fumble around. I've fumbled around and it is not fun. I always hated telling an inspector/assessor; "I know it's here somewhere!!" As far as preparing the staff, I just tell them it is business as usual, answer any questions in a freindly yet short and consise manner and for heavens sake don't do more than just answer the question. If yes or no works use them.

I suppose the only reasonable solution to all of this is a truly artifical blood substitute. As far as my statement about the FDA, if anyone can site an occasion when a decision was made that actually made our lives easier and that was a goal of the decision I'll glady apologize. The only thing I can think of that comes close is the universal donor questions. Bottom line, you want universal leukoreduction you need a better reason that making our lives easier.

To answer the initial question. The FDA will NEVER do anything that makes our lives easier. That's not in their charter. Cliff you are setting a very nasty presidence with 100% irradiated but I do understand the rational. Simplify and reduce the chance of a problem. Makes sense in a wierd sort of way. Are you using a gamma irradiator or an x-ray irradiator?

Here is a version of our emergency release sop and the form that goes with it. It is used for emergency release and when a patient is transported to another facility and the blood goes with them. I think I discovered why they didn't upload. They are the last of my WPD (word perfect documents). I will try to get them converted to a word.doc and try again. Updated to word.doc. Let's try again. Looks like it worked. TM0001f1.doc TM0001v6s.doc

Cliff, I hate to disagree with you but crossmatching does not require FDA registration. As long as you do not "modify" any blood products you do no have to register with the FDA. Pooling, Packing, Thawing, Aliquoting and Dividing are not modifying. Irradiating, and Washing are modifying.(I'm sure there are others but I can't think of them now.) The reason I know this is that our corporation is the only one with the distinction of having transfusion services under a consent decree (long story). We are not allowed to modify blood products but we can do Pooling, Packing, Thawing, Aliquoting and Dividing. We do all other pretransfusion testing and are not registered. Hope this helps. John

Does anyone know of any benchmark data concerning transfusion reactions?An example is, in the 3rd quarter this year we had one transfusion reaction for every 177 products transfused. (Nothing significant just hives and non-hemolytic febrile mostly.) Our nursing QA person who this monitors is wondering how our numbers fits in the larger scheme of things. Thanks John

This spring we got the new i-Series Freezer and so for it has been really nice. We were a little concerned since it was just available in January but no complaints yet.

We usually don't even know these patients are in-house until something goes wrong and they are on their way to the OR. This happens maybe once or twice per year but it sure is exciting when it does.

If it is in the US and is for Blood Banking it had to have it's 510K approved by the FDA therefore they will know all about it. Being first should require no more effort or "paper" than being 100th. Just make sure it does what you and the vendor say it does. If you have the money available I would go with a professional validator. In the long run they will save you much more than they will cost. Like anything, besure and check references. You want the best you can afford.

Sandy, How often have you actually retested a baby once you've started transfusing them? As long as there are no antibody problems or any other reason to retest you don't have to until they exceed 120 days old. Thanks for the response. John

Morning Cliff, we have an ABS2000 and face a similar problem. What we do is make sure that the patient's name on both labels is visible. I don't know of any regulations that forbid relabeling but I'll bet there are a few old blood bankers clutching their chests at the thought of it. :wink:

Afraid I won't be much help. Our policy has no set numbers. It depends on the patient and their condition, the current Rh neg inventory and what is happening throughout the facility. We must get medical director/pathologist on-call approval before switching but they are very good at realizing that the staff wouldn't be asking if there was any reason not to switch. I know a black and white world would be nice but your staff needs to understand that shades of grey is the real world. If your patient population is such that future pregnancies are not an issue then you probably could set a number based on your medical directors comfort level and your suppliers ability to keep you supplied with Rh negs.

Another question has come up concerning a second ABO/Rh type on a patient prioir to transfusions. If you don't have a second type and FFP and/or platelets are requested before a second type is possible how do you respond? Type specific with the type you have or do you treat them as type unknown?

We are considering requiring a second/confirmation ABO/Rh type on patients who have no previous records. We will be requiring a second sample for the testing. My question is for those of you who do something like this. Do you charge for this testing or do you just write it off as a cost of doing business? :?: Thanks John

We transfuse neonates with type specific unless there is some overriding reason not to. We set up one unit of irradiated, leukoreduced CPDA-1 RBCs per baby when their first transfusion is ordered. We start them on the freshest possible and they stay on that unit until it either runs out or expires. We do use an SCD to allow extended use of the products. We load the transfusions into syringe sets that have an inline filter so they do not have to be filtered at the bed side. The nurses really like the system.

Are you referring to the release of uncrossmatched type O RBCs to an unknown trauma patient or to a fully ID'd and crossmatched patient. These are 2 very different scenarios. In the first, the normal routine is of little value, in the second I would get the hospital risk management folks involved.

A step backward, with out a doubt!! The decision was made at the corporate level and I won't get into the politics of that but currently I can't get the decision makers to even listen to the argument let alone consider it. I just gave my medical director a proposal for a study. I want to monitor DAT for the babies receiving incompatible plasma during RBC transfusions if their initial DAT is negative. Maybe a DAT converting from neg to pos due to RBC transfusions will get some attention. Thanks for the input.

We have a very active 36 bed NICU. We currently use the standard hospital Biologics armband system with the arm band attached to the isolet. What is the pathologist's motivation in this? I'm afraid I've yet to discover the perfect patient ID solution that meets the requirements for ALL OF THE PATIENTS ALL OF THE TIME. We've made subtle allowances for NICU and OR because we had to.

This is primarily a deep philosophical discussion. The corporate clinical pathologist will never budge on this. Deglycing or washing are not options. We do not give type O cells to non-type O babies unless they already demonstrate anti-A or anti-B from mom so having a DAT develop would not be an indication. Also, we seldom if ever repeat testing during the initial 4 month neonate period. The babies are still producing their own A or B cells so the addition of the antibodies via transfusions of type O RBCs will continue to destroy them. This is probably one of those "no right answer" things that make for long and delightful discussions. Thanks for the input.