MJDrew

Good idea with A plasma! I still maintain that no one will die from a 5-15 minute wait for thawed plasma. I've been busy lately dishing out statistics on TRALI and other reactions when we have a case with borderline coags and a desire to keep FFP flowing like water. Correcting the numbers is often impossible and attempts to do so can cause a multitude of other problems, the most common being fluid overload. Yes, this can happen even in a trauma patient losing blood by the bucketful. Surgery & anesthesia staff have a unique talent for transfusing folks into cardiac failure to "correct" coag values that won't budge one iota for the duration of the calamity. BP, I would be really careful with the Factor VIIa before making this part of a trauma protocol. AABB has recently had a couple of articles in its daily mailings (Smart Briefs, I think??) regarding venous thromboses, pulmonary and cerebral emboli in troops in Iraq given Factor VIIa for bleeding, or, scarily, in anticipation of bleeding. Many trauma docs in the US are backing away from the enthusiasm they had about this product when it first was being used for this "off label indication".

We would likely have the blood bank director (me) follow up on this when the physician actually taking care of the patient was not in the thick of the situation; probably the next day. The 1-minute discourse on why this signature was necessary would be given, and sincere thanks extended for their time in completing this necessary task. I like to point out that we are not trying to make their lives more difficult; we are trying to ensure patient safety by maintaining proper transfusion documentation that is required by law. Physicians need to understand these forms are legal documents. There is NO WAY a physician not on the scene at the time of the transfusion should be signing these forms ex post facto!! Can you picture a plaintiff attorney's line of questioning if there was an adverse outcome in this patient's case?? My view is that it's your best policy to obtain signatures on these forms only from MDs who were actually involved in the care of the patient. Next day is fine. Your medical director might be useful in providing the follow up, peer to peer.

We used to have 3 FT RNs performing apheresis procedures and drawing autologous and directed blood donors. About 4 years ago, our biz in all these areas was decreasing, and it was increasingly difficult to staff the area when RNs could get paid more and work regular hours (without call every 3 weekends) in other areas of the hospital. So we first made the decision to remand the auto and directed draws to our local blood center, and then outsourced the apheresis nursing services to a contract company. This company also provides dialysis, bypass, and other services, but these RNs are specifically trained in apheresis & stem cell collection. This has worked out very well. We currently do about 550-600 procedures a year, not counting stem cell collections, which are overseen by heme/onc. Blood bank MDs still write orders and are on call for patient problems, but we no longer have the "issues" with people staying after hours or coming in the wee hours to do procedures. We simply call an 800 number and let the dispatcher know when we need an RN at our hospital. Our only professional billing for these procedures is for the initial consultation.

In spite of what your trauma docs may tell you, NO ONE dies because of a "delay" in receiving FFP! We have found it immensely helpful to have thawed, 5 day plasma of multiple types on hand for situations like these. Once a specimen is typed, plasma can then be immediately available. The last time I remember a "formula" used for massive transfusion was when I was a resident. Back then (not saying when! ) once a patient had received 6 RBCs, we thawed and released 2 FFP whether they were asked for or not. I haven't worked for a facility with a policy like this for many years now. Most of the time the patient is not in the ER long enough for FFP to be thawed if their condition is really precarious; they are whisked directly up to surgery. Our only massive transfusion protocol is dispensing with crossmatching once the patient has received 10 units of RBCs. By that time it's all donor blood circulating anyway. We just save a segment and send the type specific uncrossmatched units until things cool down... MJ:cool:

As some studies indicate that platelets may be the leading cause of TRALI, we need some resolution on this ASAP. It's becoming clearer that not all cases of TRALI are associated with the kind of antibodies you might see in multiparous women. Many, many transfusions of donor products with these antibodies are given every year to recipients who at least partially "match" for HLA or PMN type, (due to the mix of HLA types in the population) but in whom no TRALI results. So much depends upon the condition of the patient prior to transfusion. Have they received the "hit" of a trauma, surgery, etc, to "prime" their PMNs? Do they have enough neutrophils to mount such a response? Is it biological mediators in the stored unit that cause the reaction? It's a complex issue. I'm going to stick my neck out and say that this sort of "blanket" deferral (which in reality it is, even tho we are so far singling out one product) reminds me of some of the early HIV deferrals by geographic area, prior to testing being available. Not very effective, like killing a fly with a sledgehammer, and terrible PR. How are we as a donor collections community going to handle the inevitable misinterpretation of this donor selection in the popular press? How many donors who don't have good information on what this is all about will be turned off enough not to donate? I haven't seen any of these questions answered yet; maybe we have to wait and see. But we'd sure better have a strategy to deal with it. Red cells also cause TRALI. I have yet to see anyone suggest that we turn away females from donating red cells! Another case of, half a loaf is better than none--or, the precautionary principle in action! MJ:cool:

Some references will state 1 bag of cryo/7 kg of body weight, so you get the "standard" 10-unit dose for a 70 kg person. If someone's FBG is less than 90-100 mg/dL, with ongoing blood loss, you probably should give 15-20 units at a time. MJ:cool:

We basically pool whatever is available, usually keeping it ABO compatible, but it can sometimes be a mix of types. Even in a 10 unit pool, by the time the small amount of plasma is mixed in the patient's total blood volume, it's like spittin' in the ocean! We have 900 beds and a level one trauma center, usually have 200 or so units on hand. MJ :cool:

Yeah, the "blame game" sort of inspection really makes you want to bend over backward to report these deaths & complications, doesn't it?? The agency needs to take a cue from kids--if you know you're going to get "punished", the natural human tendency is to hide the evidence! MJ

B, I would have been livid as well if the incident you describe had happened in my blood bank/donor area. I really have no clue why the CSOs believe their agency has jurisdiction over products that are not intended for transfusion. Of course, with the error reporting (BPD) system, we can also take it on the chin for specimen labelling errors and others occurring outside the blood bank! Figure that one out! Thank heavens we no longer collect auto or directed donors!!! The last couple of inspections we've had have been heavily weighted toward a microscopic assessment of transfusion reactions (probably to see if we're missing reporting any TR deaths or serious reactions, such as TRALI), which is TOTALLY outside the realm of these folks' expertise. At least it is when they start trying to tell me that 2 physicians deciding a reported complication was not transfusion-related is not sufficient. At one point I actually indicated to the inspector that I didn't realize her position with FDA required a medical license! That stopped that line of questioning very quickly! MJ

"Processing" is the key word in the CFR, and is less confusing than using "manufacturing" or "modifying", or "manipulating"...etc. Hospital blood banks are defined as entities that routinely collect or process whole blood or blood components. Collection may be via apheresis or products may be prepared from whole blood. Processing includes: freezing, deglyerolizing, washing, irradiating, rejuvenating, or leukoreducing red blood cells. These facilities must register with FDA. Transfusion services are defined as hospital laboratories that solely prepare red cells or recovered plasma, pool platelets and/or cryoprecipitated AHF, or as facilities that issue bedside leukoreduction filters. These facilities are not required to register with FDA (21 CFR 607.65[f]). Emergency collection at these facilities does not require registration. Currently, the only reason my facility is FDA registered is for irradiation. We used to perform freezing, deglycerolizing, washing, and rejuvenating, but no longer perform these functions. If there was a way to offload the irradiation to a local blood center for the cost and TAT that I get doing it here, I would do it in a heartbeat, and lose the registration. But this is not to be!

We instituted a second sample at the time of RBC request in patients whose first (and only) type in our system is not O. The second sample is collected with a fingerstick collection device with EDTA, in order for us to be sure we are getting an actual second sample. The ER will double draw every time, and if a mistake is made, it's just duplicated. We send a "packet" including the device, an alcohol prep pad, sterile gauze packet, bandage, and complete INSTRUCTIONS on how to collect & label. A quick ABO/Rh confirmation is done on this, if all is OK, the crossmatched blood is released. Predictably, the only area from which we have had any pushback with this was the area that caused the protocol to be put in place in the first place, the ER. :mad: (We had 2 ABO mistransfusions due to WBIT samples from the ER in the space of 24 hours, a couple of year). Fine, you don't want to give us a fingerstick sample, we'll supply type O blood and ask the OR to do it for you! I have had to encourage the creativity of the anesthesiologists on where to obtain "fingerstick" samples when fingers may not be available. Earlobe, shoulder, upper arm, etc, are all fine. In the 2 1/2 years we have had the protocol in place, we have "caught" at least 6 wrong types where patients initially typed non-O were actually O. So it still happens. I would love to be sure that everyone drawing blood was trained to do it the right way, every time. But the lab in our facility no longer has jurisdiction over phlebotomy, and there are too darned many people, who turn over too often, doing blood draws for this to be practical. We have not seen a great deal of "excess" type O use waiting for fingerstick samples. The blood bank leadership enforces the policy with applicable department heads, as needed. We will never withhold blood from any patient for the lack of a fingerstick, type O is always available. Once the applicable staff get this thru their heads, we see no trouble with compliance. I try to regularly reinforce good inventory management with appropriate areas.

We take FFP directly to thawed plasma and label it like this from the get go. We have only neonatal ICU; no other pedi patients, but would use regular FFP thawed at time of order for these. Right after we instituted the protocol several years back, we had both an FDA and CAP inspection within a few months of one another, neither of which had any issues with the process we use. We thought we would make more mistakes trying to initially label it thawed FFP and then having to switch the label to thawed plasma by missing the 2nd relabel at 24 hours. FDA mentioned that we were labeling by "least common denominator", ie, we were not claiming the product was anything more than thawed plasma. A product labeled thawed plasma MAY exceed standards for thawed plasma if it is within the initial 24 hours after thawing. This is not a problem; it is the product labeled thawed FFP that is more than 24 hours old that is a "misbranding" problem with them.

Yes, I agree the Galileo is a heavyweight! We incorporated "Leo" into a specially built countertop/storage/work area to get the most out of our limited space once he was installed. We enjoy working with him. He's like a member of the family! We had budget money to purchase other instruments earlier, but waited for Galileo because it was the first truly "walkaway" instrument that could handle our volume. The Echo, which is the new, countertop version of the Galileo, is into clinical trials. We'll be participating in these next month, so will let you know what we see. MJ Drew

Greetings from the land of the Great Lakes! I've looked around here for awhile and decided to join up. I'm medical director of a transfusion service for a 900-bed hospital in Detroit, MI. I also oversee apheresis and pathology resident teaching in transfusion med. In my spare time I enjoy travel, collecting art pottery & SW jewelry, and generally causing upheaval in the blood banking community with my frank (but experience-based) opinions! MJ Drew