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Iron Management in Blood Donors


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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.  :blink: 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!

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It doesn't happen in the UK - there is a minimum Hb to allow donation. What's the point in issuing short packs to patients either - I'd much rather give a 320ml fat pack than a 220ml one on a patient who is borderline iron deficient (I've not seen a pack in the UK yet with less than 220ml in). Iron deficient donors mean that patients are having increased number of donor exposures due to being 'short changed' in their transfusions.

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Auntie-D ... just to clarify.  There is a minimum Hgb to allow donation, there is also criteria required by each device to ensure that a donor's hgb does not drop below a specified level (Trima is configurable down to 10g/dL.  Haemonetics is somewhere around 10.3).  The "anemic" designation that MJDrew is talking about isn't always the Hgb level, but the donor's ferritin level.  The problem here is not necessarily the cost to test the ferritin, but what to do with the information once you get it.  My blood center initiated ferritin testing on all apheresis donors (assuming increased frequency would have larger depletions - although we do NOT collect apheresis RBC products at all).  In the first month we deferred between 30-40% of our donors for low ferritin levels (all donors had 12.5 hgb or higher prior to donation, and only lost RBCs in samples and kit residuals.  More than 8 weeks (often more than years!) since their last WB donation).  If we continued deferring donors with ferritin levels outside the "normal" range, there would not be enough products to meet our patient needs.  Ever again. Of note, again, we were NOT COLLECTING RBCs from this donors.  
So, if we want to continue meeting our patient needs, we need to be more selective in who we defer.  FDA/ AABB have no suggestions on what that number is, and talking to other centers who are testing donor ferritin levels, there is a wide range of numbers used to create this deferral.  One blood center only is concerned about ferritin levels in women of child bearing years.  Their argument being, that (as the FDA/ AABB report) we DO NOT know the impact of low ferritin on our donors, and it seems that a large population walks around daily with low ferritin levels (and normal hgb levels) there IS data that lower iron stores can impact a developing fetus.   To me, that seems like a good place to start.  As with all decisions regarding blood donors, while our first approach is always to first do no harm, there is also a balance between an unknonwn risk, and meeting patient needs.   As I understand it, what the FDA/ AABB is asking for is some help in trying to determine what is a sane and logical point to start deferring donors that is not going to defer 30-40% of a normal, healthy population and create a health crisis in this country of epic proportions. 
(p.s. I've seen a donor with a hgb of 16, and crazy low ferritin levels.  It's a fascinating measurement that defies logic).

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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.

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I agree with everything that has been said. We do need to take better care of or donors.  However as with most issues where people have trouble doing the right thing, money is involved.  Doing A ferritin on each donor can add $6-$7 per donation.  Perhaps it can be done selectively, for example on those donating more that 2 times per year, but this is labor intensive in the setting of a community blood center.  Administering iron replacement tablets to donors is also a possible solution.  We have seen that as little as 19 mg of iron is effective at reversing the iron depletion effects of blood donation.  The cost of acquiring the iron supplements and administering such a program also incur additional costs that would need to be added to the unit of blood. There would also be benefits from reduced hemoglobin deferrals, but they are difficult to quantify. Another way to address this is to increase the interdonation interval such that men donate ≤ 3 times per year and women ≤ 2 times per year.  Mayo in Rochester has tried this approach. This works for them because they supplement their blood supply with blood from another provider and have been able to manage the decrease in units. 

All donors must have a 38% HCT or 12.5 gram HGB soon to go to 39%/13 for males in the US.  However, these numbers do not correlate too well to the donor's iron stores as predicted by ferritin levels.

 

So there are solutions.  However for those of you in the hospital setting, what price increase would your administrators accept in order to help your blood provider take care of their donors in an extremely competitive market? 

 

Finally, I am wondering why we are just now recognizing iron deficiency in blood donors now?  Is it because we are looking for it and it has always been present, or is it something else, like a change in diet.  Is the bioavailability of iron in our diet so different that we more easily become anemic?  If 60% of blood donors are anemic before they even start donating blood, that suggests an iron availability problem in our environment......   Decreases in cast iron cooking pots, decreased red meat, fruit harvested when it is green, more processed foods... I wonder if these may be contributing to the iron deficiency.

Some years ago high iron levels were supposed to be associated with heart disease; are people purposely choosing diets to reduce iron uptake?  

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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.

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What I have been seeing is that the bulk of our donors donate 1-2 times per year.  The last time we looked at the donor frequency it was less than 2, 1.3 time per year I think.  I implemented a program whereby donors without a passing hemoglobin level were deferred 56 days rather than the usual 1 day at most centers.  The blow back from the donors was phenomenal. Quite a few , especially women were shocked that I wanted them to wait for an extended period before their next attempt. Before I could see if there was any difference in deferral rate (the hope was that by decreasing the inter-donation interval the number of hemoglobin deferrals would fall) administration pulled support for the project.

Surprisingly I suspect there is also an iron deficiency problem in platelet donors too.  For some of them it is because they concurrently donate red blood cells with a platelet donation.  In the platelet only group I suspect it is because they have borderline iron stores to begin with.  They donate frequently enough that the volume of blood taken for samples is enough to put them into a negative iron balance.  I can see the hemoglobin fall over time.  Fortunately I am able to detect these donors and write them a letter asking them to be evaluated and if indicated take an iron supplement.

Regarding high school donors, many blood collectors only visit a given HS 2x per year.  At least this is our approach.

Recruiting donors is tricky.  As the saying goes, If it were easy to do, everyone would be doing it.  However with proper blood management in hospitals, the demand is going down.  This will make blood centers more selective about the drives they choose to run.  At least is has had that effect on our center.  Nationally we are at about 50 transfusions per person in the US.  Canada is at about 33 transfusions per person.  So thee is a lot of room to fall still.

 

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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.

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I guess this is a step in the right direction:

AABB Standards:

Unlike the 29th edition, the 30th edition requires that donors receive educational materials about the risk of becoming iron-deficient as a result of blood donation.

 

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  • 5 weeks later...

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.

 

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