MJDrew

I agree, given the total lack of ANY regulatory action on this for years, this is a positive development. How many donors will actually follow through with this advice, or with letters from the blood center if their ferritin is tested and found low, remains to be seen. One potential solution for the issue of the cost of initial ferritin testing is for the blood center, many if not most of which are not-for-profit entities, would be to approach major private and corporate donors in their communities with a concise presentation of how their support of this testing would improve the health of donors and assure a safe blood supply for the community. I work as a volunteer for a private, NFP FM radio station locally, and these contributors are called underwriters. They provide major financial and in kind support for station operations and/or specific station needs/projects. Perhaps NFP blood centers would be able to avail themselves of this model to finance special projects such as this. Major donors could also be approached to set up foundations specifying the areas of their support, and funding could thereby be generated for an expense such as this. Contributors' generosity could be liberally publicized in the community to garner further support of this type, as well as to draw attention to the importance of the blood center to the community. This all takes a large amount of work. However, I would again emphasize that we as an industry need to be more creative with solution finding when challenges like this present themselves, rather than "passing on" increased costs to hospitals and other end users of our services.

All the best to the hardworking laboratory professionals who do their utmost every day to ensure the quality of results and safety of the patients we help to treat. We in the lab may be "invisible" to most patients, but there is not a diagnostic or treatment decision made without the support of the lab! And Malcolm is absolutely right--there can NEVER be too much dessert!

When I worked in a major trauma hospital a few years back (early 2000s!), we simply started out converting the FFP to thawed plasma at the outset, to prevent issues with forgetting to relabel, confusion over dates, etc, as stated above, in our busy transfusion service. If I were directing the transfusion service there now, I would definitely have made the switch from AB to A as well.

To me, this would fall under the "urgent medical need" heading. The standard you are referring to indicates only that the blood bank needs to have a policy for transfusing components with "large amounts" of ABO-incompatible plasma, not that such components cannot be transfused. As long as this is a policy approved by the necessary departments in your facility, and signed off by your medical director, and it is followed, my opinion is that this would comply with the intent of the standard. Another example of invoking urgent medical need (which I had to do on several occasions in a large transfusion service) was to approve the transfusion of platelets >5 days old when there was NO supply of platelets coming in on a specific day, and there was a patient in urgent need. These were signed out in the BB computer system as "urgent medical need", I was called as medical director to approve the release, and we had a policy in place to cover this. As the BB supervisor was heard to say, the platelets didn't all lay down and die at MN on day 5! Never had a recipient reaction with this practice.

Our procedure at multiple hospital transfusion services I directed was a T&S.

ALL of the advice here is very good, and I would take ALL of it, most importantly the part about getting to know your regional accounts manager (ARC"ese" for customer representative, customer service rep, etc.). And also that about being very specific with your questions, as per your needs. One nugget I would add is, as a former ARC customer and ARC medical director (ie, both sides of the coin), I would caution that experience with ARC can vary greatly region by region, as may be the case with any large, national company with multiple, regional stores, centers, etc. From my time on the hospital end, the reference lab piece was VERY important, as both hospitals where I worked saw a lot of complex patients with crossmatching challenges. It might be a good idea to discuss this piece by conference call with the accounts manager and the IRL (Immunohematology Reference Lab) supervisor, to more specifically address whether your needs and TAT requirements can be met. Due to staffing, demand for services and other issues, IRLs may or may not have on site coverage after hours and weekends, and on call staff would need to be called in for these cases. There is also the possibility of writing a contract with ARC that does not include IRL services if you are not convinced your needs can be met. BTW, the "inside" slang for a former ARC employee is "FARCE". So there--it's out!

Wow, you had some formidable challenges in trying to implement your policy. I can only imagine that admin would be reluctant to be supportive at the start of this; in the face of donor complaints, what else to do but pull the plug, in their view? It is as if we are between "a rock and a hard place" with this issue. I agree that many platelet donors are likely coming in with low iron as well. The perceived or real need to collect multiple products by apheresis is also driving the hgbs downward in this group, no doubt. While I know that more centers are looking at running fewer drives, the trend toward consolidation and "affiliation" of independent blood centers with larger corporate entities is also increasing draws at smaller centers who were previously looking at drastic reductions in business, or even closing, without this type of corporate support. Blood is a commodity to be distributed throughout a large network rather than in the community. While this may be a more cost efficient business model for now, this may also result in more donors being collected more frequently to meet demand. Casting a wider net with under-recruited groups would help, but this is far easier said than done.

My thoughts on whether or not this is a new phenomenon may well be biased; I'll say that at the outset. I do believe that the availability of iron through the diet has definitely decreased, for all the reasons Kip outlined above. Also, plant-based iron is simply not as well absorbed by the body, as it is not as bioavailable to the body as heme-based iron (read, red meat sources). But given the above, when I ran a hospital based donor center, we saw the same issue, but only when we looked for it in donors with hgb levels that did not meet our cutoffs. Once in awhile I would pull samples from donors whose hgb did pass, and many--probably around half--had low ferritin levels. (That with the caveat we considered "low" to be <50). Low sample size, but it was still there. As it was a small donor center, I would usually call these donors individually, and advise them to consult with their physicians regarding any need for iron supplementation. I would also advise them to decrease WB donations (often suggesting a switch to platelet apheresis donation) as well if they were donating more than twice per year. So I think this issue has been around a long time. My prejudice is that the industry has focused for many years on meeting demand for blood that is often unnecessarily transfused, and that a growing groundswell of concern has forced the issue. Many have been concerned about this for years, but especially in the blood center environment, it is difficult for a physician to stand firm and tell their donor recruitment and management that we need to decrease the frequency of donation in some donors. My view is that our recruiting needs to be more creative with the huge population of 25-49 year olds, many of whom we seem to lose as donors as they leave high school/higher education.

Smarty, you're quite right about what to do with the ferritin results being the key thing. Also, where your cutoffs are do matter a great deal. I get concerned with levels <20 and trying to donate RBCs. Some of the men I was alluding to in the post had ferritin levels <10, which is essentially zero iron stores. Your results are quite revealing, and indicate what I've seen and read over the years, that most Americans do not get enough iron in their diets without taking supplements with iron. Donating RBCs in addition to the low or absent ferritin does not help the matter. Thing is, the hemoglobin is the last lab test to "go low" in a low or absent iron stores (AIS) situation. Once there are no or near no iron stores in the bone marrow, then the hgb starts to drop. By the time the hgb gets below donation range, then ferritin may actually be close to 0. If I were initiating this test, I would limit it to DRBC donors, male or female, and I would agree also with testing women of childbearing age. I would have particular concerns with young female donors (19 and under or 21 and under, wherever your cutoff for this is). Also important is to decrease the number of unnecessary transfusions via blood management, preop anemia clinics, and educational strategies at end users facilities. Even with these in place at some hospitals, US RBC transfusion rates are still higher than many other countries. We need to take a stronger stand on the safety of our donors.

Greetings, I'm back in the fold again after several years away. Had to get back in the fray once again as being semi-retired now, I found I still need the stimulation of the verbal joust with my peers!

The latest AABB News is featuring several articles on low iron in blood donors. The only question I have in light of this is: WHERE HAVE THEY BEEN?? By "they", I mean the AABB, CAP, FDA, and every other agency who regulates our lives in blood banking and supposedly has the best interests of the donors in mind when writing said regulations. The one truly incomprehensible statement, by Dr. Steve Kleinman, indicates that we haven't proven that iron deficiency is clinically harmful. By what metric? How many studies need to be done showing definitive clinical harm? Anyone who has been iron deficient can testify to definite clinical effects from low iron--once it is diagnosed and they are repleted with supplements. "Oh, yeah, is this how a person is supposed to feel? I thought it was normal to be tired all the time, crave ice chips, and have restless legs at night!" The worst part of this is, to me, that our donors come to us trusting us to have their best interests at heart and assuming we will "do no harm". Yet the blood center has and always has had an inherent conflict of interest in this matter--they need to collect blood to meet patient needs, and pressure is (at least until recently) always on to collect more, even though this may mean donors are walking around at least iron depleted, if not outright deficient. This may be even more the case with younger donors, on which collections centers depend heavily, because, let's face it, they are low hanging fruit. I have to confess I did not appreciate the scope of the problem until, at my last employer, I started seeing, O neg, male, double RBC donors, who had agreed to do 3 DRBC collections a year, after regularly donating WB every 8 weeks for several years, coming to my attention. It seems that several (at least a half dozen) were unable to do their usual activities after one or more DRBC donations; one particularly memorable story involved a donor having to be carried off the golf course because he became so short of breath that he could not finish 9 holes, walking, which he had been doing for years. When they saw a physician, their hgb was generally <10, and in several cases, <9! All had ferritin levels below 20, which is iron deficient. And, since all were middle aged men, they were all subjected to colonoscopy, as GI bleeding is the leading cause of low hgb in men this age! I was put in the position of telling these donors they needed to take their supplements faithfully as well as take a prolonged break from donation. For this medically sound advice, I was called out by several managers for decreasing the donor base, while I was trying to keep donors safe! As blood donation is a voluntary activity, we need to be especially cautious of doing no harm. The STRIDE study (Strategies to reduce iron deficiency in blood donors (STRIDE). Transfusion, 2016; epub prior to print) showed that 60% of donors tested were iron deficient AT BASELINE!! Several interventions, including thank you letters, letters with ferritin level and advice to take daily iron if ferritin was low, as well as 2 levels of iron supplementation provided by the center, were performed. Surprisingly, the donors receiving the "low ferritin" letters with advice to take supplements for 8 weeks did nearly as well repleting their iron as the donors actually receiving iron pills from the centers. How hard is this? Yet the story indicates there is reluctance to initiate ferritin testing due to expense! Gee, what other tests have we done for years with little or no proof of efficacy for their stated purpose? I would welcome add'l input and thoughts on this topic; as you can see, it has been bothering me for some time!

I have editions 14, 15, & 16 of the AABB Technical Manual that I would hate to just toss. I am looking for any potential users of these and am willing to ship. Let me know! Thanks and glad to be back! MJD:D

There is a practice of medicine issue here because the risk of infection in each case must be assessed. This assessment, whether on the part of the transfusing MD, or the blood bank physician, will determine how to frame the notification. If the transfusiing MD notifies, he or she must then inform the BB/transfusion service whether or not the recipient/representative was located. This is what is documented by the transfusion service. As the transfusion service MD, I was not the one who assessed the patient's need for the transfusion and ordered the transfusion be administered. This is the responsibility of the ordering MD who is caring for the patient. I do not have a strict "doctor/patient relationship" with the recipient. This was an issue that I discussed with my physician staff at my last hospital post, and made it clear that, as the physician with the primary care relationship with the patient, they were expected to make this notification, or assess the need to notify, based on information I provided. This policy was approved by our medical staff council. As far as risk of transfusion of units donated prior to the HIV+ unit, this depends upon the prior testing done on the donor; ie, how many years ago were prior donations made? If all previous testing was NAT tested negative, and there has been a gap of 6 months or more between the current, positive donation and the last negative donation, I feel confident in (confidentially) assuring the treating physician that the risk of HIV infection from prior units is very low. The longer the gap, in all likelihood, the lower the risk. Most of the very few HIV+ donors I see now in the blood center setting are either first time donors (no notification of recipients) or what we term "lapsed donors"--donors whose last donation was >2+ years ago. While the physician cannot share donor information, I provide this in confidence to assist the MD in making the decision how/whether to notifiy. This to me constitutes a reasonable attempt to notify. I stand by my prior assertion that the physician's decision to notify or not notify patient family/representative is a medical decision and is not under the FDA's jurisdiction. When the treating physician is notified, the notification has been made.

I would concur with that assessment! And given the article in the May 2012 issue of Transfusion, detailing a fatal case of transfusion-associated graft vs. host disease in a type A combat casualty in Afghanistan being given the magical potion of type O "fresh, whole blood", I would think this practice would be forever wiped out everywhere. Tranfusion-transmitted infection isn't the only potential risk that could result from this sort of magical thinking that, somehow, the blood is better when it's still warm. :disbelief An episode like this is totally unforgivable in this day and age, when we know that TA-GVHD can happen even in patients not usually thought of as immunocompromised. Trauma causes profound suppression of the immune system!!! READ MY LIPS!! Perhaps some of our military friends will enlighten us on whether this resuscitation policy will continue. MJD :cool:

I would agree with the above. The CRP is a "marker" for an inflammatory process that is going on. In and of itself it really has no meaning as far as being eligible to donate; it would be more the underlying diagnosis (assuming there is one) that might present a problem. Some medical providers use the CRP as a screening test for "whole body inflammation" to attempt to sell various naturopathic or other treatments, but this is not a standard test for any given disease. MJ

This is indeed interesting. So we can request a "variance" from the FDA from the notification requirement? This is a medical decision on the part of the physician not to notify the next of kin when it is clearly not needed. The FDA representative clearly stated this is a matter of medical discretion, which takes it OUT of the agency's purview. Our responsibility is to notify the physician, point out that it need go no further if he/she feels it is not necessary, notify FDA that the contact has been made, and leave it at that. That is the requirement. Is the FDA policing the practice of medicine now? It certainly seems they are. It is none of the agency's business what happens with the notification once the appropriate, required contact has been made. You would never find me filing paperwork for a "variance". Why don't they just rewrite the regulation to allow for the medical discretion? Our tax dollars at work! MJD

I should have mentioned in my last rant (!) that we had actually approved this with our solid organ transplant docs as part of a tranfusion committee discussion, ie, when you order uncrossmatched on one of your patients who normally would have irradiated blood, it will be assumed to be an emergency and since each unit will take >3 minutes to irradiate, what you'll be getting won't be irradiated. This was written into the BB policies for massive txn, emergency txn, etc, as well, and these changes were published in our monthly lab newsletter, print & on intranet. If you have evidence these conversations/information were distributed, and there was opportunity for questions, this would at least help you "cover" for situations where there is not time to irradiate and staff may not be available for an approval of un-irradiated units. MJD

This is a medical decision, as the units were ordered uncrossmatched, presumably on an emergent basis. Medical decisions are not in the jurisdiction of the FDA in a situation where blood is emergently needed and there is no time to irradiate prior to release, regardless of whether it has been discussed with the attending MD. The key factor in answer 3 is "not discussed AND not emergency release". Technically, there is no difference in purity/potency based on a discussion or no discussion prior to transfusion, regardless of whether there is actually time to irradiate. The risk of TA-GVHD, while there, is miniscule with randomly selected, LR RBCs. If the patient is losing blood that fast, how long do those lymphocytes have in the circulation, anyway? In my biased opinion, irradiation is a medical decision to begin with and individuals at the FDA who are not in possession of an MD degree have no business ruling on this one way or the other. Since I am not certain as to whether the FDA employee answering the query was an MD or not, I can't assess the validity of their answer, as it pertains only to procedural issues. I am assuming the respondent was not an MD. MJD

When I was in a hospitals service, we handed off factor concentrates to the pharmacy in about 1999. Pharmacy also took on albumin around that time. Transfusion service was left with RhIg until handing that off a couple of years later after a pharmacy computer system upgrade allowed the floors to order it directly after receiving instruction from the transfusion service as to how much to order. MJD

Just an update after speaking with Edwards Lifesciences--they apparently do not make this instrument and have no idea who does. I will try to search the FDA CBER site for a new device clearance and check other manufacturers. The hunt is on!

I'm hoping some of you can point me in the right direction. I am trying to assist a hospital customer with a rather serious issue concerning the Aquarius apheresis instrument, which I believe is manufactured by Edwards Lifesciences. More specifically, the filter used with the device, the Asahi AP 05H(L), clogs and blocks blood flow with the usual citrate concentrations used for therapeutic apheresis. When the staff at the hospital call the filter manufacturer, they are told the filter "doesn't like citrate", which sounds really screwy to me! The filter folks have told the staff that they need to heparaize the patients in order to use this machine, and not use citrate. This would be great except a couple of patients they had tried to do procedures on were post-cardiac surgery and had some bleeding issues afterward. There doesn't seem to be any customer support at all for this instrument and the staff are scared that they will have a really serious event. It is a community hospital not near a large city, so if there was an issue, it could potentially be a real problem. Has anyone used this instrument, or have any advice on whether citrate can or cannot be used with the filter? Thanks for any help you can give. MJD

John, you know what they say about keeping those brain cells in shape! Flex those dudes, now, trying to remember all that stuff! Best of luck to you and remember to stay in touch. I do occasionally make it out your way (my family is in Denver). Test me! Do I know the small WY town to which you're retiring? I lived in CO for 30 years. :boogie:MJ

I hadn't had the chance to visit for awhile, but when it comes to this, don't get me started! :mad: In response to the questions re: electronic fingerprinting, I think anyone in the healthcare field needs to be fingerprinted electronically. Being the compulsive handwashers we are , many if not all of us have poor fingerprints for the manual method. We actually rub them off!! This just adds insult to dirty fingers when asked to do this multiple times with an outmoded technology! So insist on the electronic method if it's at all possible. Just a hint, although it might not be doable for large health systems or departments, it could work for an individual: Most PIs (private investigators) have the electronic method readily available and are more than familiar with the issues health care folks face. I found this out by accident when having to be fingerprinted for multiple new state medical licenses for my new job, as the local PD here in Portland refused to do this(??). What possible benefit 6 different forays into the same FBI database has for the states licensing me, I cannot say, but as has been said here, this is a new world we live in. As a good friend said after I had related the above tale of woe: "You could have had a second career as a criminal with your lack of fingerprints!"

Thanks, OPUS104. That's a good idea. We're especially looking for something to attract attention at the donor site, as we recognize that prospective donors do not always read all the pieces of paper, brochures, etc, that we may provide!

Greetings, all! Very busy past few months and no time to post but now have a dilemma on which I need some feedback. We have recently had some issues with HS donors who are also competitive athletes (and their parents) becoming irate due to a decrease in performance in the days after a donation. We provide basic info on the appt card re: hold off on strenuous activity for 24-28 hours, rehydrate, no heavy lifting, etc., but nothing specific re: athletic performance, particularly for endurance events like track, basketball, etc. We had one track competitor ask about doing a meet the next day after donating, but it was at the end of the phlebotomy! Anyway, does anyone have specific information they provide either to drive coordinators, to their recruiters, drive staff, etc, to answer these questions? Do any of you have written info specfically for athletes at a site? Thanks for your input! MJ :cool: