I issued a unit of O neg blood to a patient with an (active, not RhIg)  anti-D.  About 10 minutes later, I discovered that the tech who crossmatched the blood only did IS, not extended.  First I started the extended.  Then I called my supplier and made sure the that all Rh neg units are tested for weak D.  My crossmatch was finished in about 17 minutes.  (negative).

 

In retrospect, I think that I should have called the floor and the transfusion stopped.  I debated it, but didn't want to raise any alarms with the unlikelyhood of a positive crossmatch. 

 

PS, I had no supervisor or pathologist in house to consult.  By the time I got off the phone with my supplier, the crossmatch was almost finished.

 

My question, should I have called the floor?

What country are you in?

 

If that had been me I would have called the floor first and asked them not to initiate the transfusion and to return the product to the transfusion service. If the product had already been spiked I would have asked them to put it on hold pending the completion of your testing.

A manager I had when I was a young private in the army gave me their golden rule to use when I'm thinking about these kind of scenarios: If the patient getting that blood product was your child, would you have asked them to stop or hold off on transfusing until after you had the results of the crossmatch? Certainly.

 

This is definitely an issue that should be reported through your quality/occurrence management department. If you're in the USA this should be reported as a biological product deviation report to the FDA, QC-93-14: "Testing not performed, incompletely performed, or not documented for Compatibility".

You should have called and held the crossmatch, the patient is the important factor here, and if the crossmatch had been positive it could have been bad.

Question for you.  Was the antibody screen / antibody ID positive ONLY for anti-D?  If so, I would probably have done just as you did. (Hard to say without actually facing the situation)  On the other hand, had there been any indications of additional antibodies I would certainly have contacted the nursing unit. 

I would question why your system let you issue blood on a patient with an antibody that was not cross matched through AHG phase. Our system (HCLL) sees anti-D as a level three antibody and would have never let us tagged the unit unless it was emergency issued.

Question for you.  Was the antibody screen / antibody ID positive ONLY for anti-D?  If so, I would probably have done just as you did. (Hard to say without actually facing the situation)  On the other hand, had there been any indications of additional antibodies I would certainly have contacted the nursing unit. 

I agree with John and I would have crossmatched the unit "real fast".  I would report this error to the FDA as well complete a patient safety event. 

^{you should call the floor and stop the transfusion or hold the transfusion ,}

 

^{2nd we have a policy that as you recived the O-neg  from  our supplier we always rechecked the group and also for week D.}

 

^{as we are working in trauma centre and many time we send O neg with out any test or just on IS , so our all O neg in out stock is Already checked .}

Sound advice, all. I would have called the floor and asked them to hold off spiking the unit for a few minutes or, if already started to infuse, turning it off and letting saline run (after reassuring them that it was "just a technicality" and that the blood issued should still be fine for the patient). They would have been able to wait a couple of minutes. For patients with antibodies, assuming your antibody ID is thorough and accurate and the units are correctly antigen-screened by you or in this case the blood center, full crossmatches are really just a redundant extra layer of safety to check on the above said assumptions. And yes, report to lab/hospital QA and the FDA.

Well, what was the true patient risk here? You know the patient had an anti-D. I presume that at the time of identifying the anti-D you did a proper identification with your exclusions and inclusions. So what other antibodies could be present? A possible antibody against a private. If your panel is not capable of excluding other 'common' antibodies in the presence of anti-D (I am sure it is) then you should change your supplier. So then there is the risk that your units of blood are weak or partial D and not true D neg units. Don't your blood suppliers check that? Of course, they could have made a mistake, but what are the real chances of that? And, if you check your units (not necessary in every country) don't you check then when they arrive?

So the real patient risk is absolutely minute in this case. On the other hand, I can well imagine that stopping the transfusion half-way through could give rise to a lot of unneccessary panic and increase the risk of errors because the team carrying out the transfusion had been panicked.

On the other hand, such a situation should not be allowed to happen again - in another situation, the risk might be more real. Therefore I would not beat myself up about what was already done but I would calmy look at the existing procedures, including training, and improve them.

Galvania, your arguments are getting at the concept of "why do we do AHG xms on patients with antibodies if we are certain that we are giving them antigen negative units?"  Because our rules require that we do so, it "must" have been determined that the risks you describe justify the extra testing.  So those have become the standards as well as our SOPs.  If we don't follow an SOP as written, we need to write it up as a reportable event as others have said.  Of course, there is a good likelihood that the rules just made some old blood bankers feel better rather than being based on firm evidence.   That said, we need to keep it simple sometimes and not have one set of rules for anti-D and another for prior antibodies no longer detectable etc.

Galvania, your arguments are getting at the concept of "why do we do AHG xms on patients with antibodies if we are certain that we are giving them antigen negative units?"  Because our rules require that we do so, it "must" have been determined that the risks you describe justify the extra testing.  So those have become the standards as well as our SOPs.  If we don't follow an SOP as written, we need to write it up as a reportable event as others have said.  Of course, there is a good likelihood that the rules just made some old blood bankers feel better rather than being based on firm evidence.   That said, we need to keep it simple sometimes and not have one set of rules for anti-D and another for prior antibodies no longer detectable etc.

Edited June 12, 201312 yr by Malcolm Needs

I think I can shed some light on to why a serological cross-match should be performed once a clinically significant antibody has been detected.

Once such an antibody has been made, it has been shown that the recipient is a responder. It has been further shown that, once such an antibody has been made, the recipient is likely to make further antibodies. These "further antibodies" include specificities directed against low incidence antigens of all specificities (by that, I mean, not just the antigens in the 701 series, but also those assigned to Blood Group Systems and Blood Group Collections). Many of these antibodies will be clinically insignificant, but some are quite definitely clinically significant, and it is to detect these, in the cross-match, which would not be detected either in the screen or the antibody panel, which require to be detected in the serological cross-match.

Whilst someone making these "extra specificities" may, in itself be rare, that was the arguement put forward in the Guidelines.

Something strange happened there!

Bottom line, there is "potential" (FDA's word) to harm the patient and the product has been 'distributed', so it must be reported to CBER as a biological product deviation. I would vote for Dr Pepper's game plan to handle the situation.  The patient has an expectation of safety.

I think I can shed some light on to why a serological cross-match should be performed once a clinically significant antibody has been detected.

Once such an antibody has been made, it has been shown that the recipient is a responder. It has been further shown that, once such an antibody has been made, the recipient is likely to make further antibodies. These "further antibodies" include specificities directed against low incidence antigens of all specificities (by that, I mean, not just the antigens in the 701 series, but also those assigned to Blood Group Systems and Blood Group Collections). Many of these antibodies will be clinically insignificant, but some are quite definitely clinically significant, and it is to detect these, in the cross-match, which would not be detected either in the screen or the antibody panel, which require to be detected in the serological cross-match.

Whilst someone making these "extra specificities" may, in itself be rare, that was the arguement put forward in the Guidelines.

 

Even in my short career I've run into several of these: Jsa, Kpa, V, Lua, Cw, Wra. There have probably been more inconclusive incompatible crossmatches that we attributed to "antibody of undetermined specifity" because of gel testing that could theoretically had some sort of real specificity.

 

Thank you for your post Malcolm, that was how I always understood the reasoning of the guideline.

Dar all

I was not suggesting that in general it is not necessary to crossmatch when antibodies are present. Nor was I suggesting that anyone ignore their SOPs, or that you need 1 SOP for patients with anti-D and another one for the other cases. Of course, a crossmatch should be carried out if an antibody is present, and for good reasons. However, in this case it was not - erroneously. What I was trying to do was look at how much of a risk the patient had actually been put to in this case, and concluded that actually the real risk in this case was almost non-existant. In another situation that might not have been the case. I think the most important thing to do here is instigate some serious training in the lab to make sure that everyone is aware of the importance of following SOPs. I still maintain, though, that in real terms and in this case, this patient's safety was compromised less than it would have been done by panicking the staff into stopping the transfusion..

But aren't they starting to think that there are many people with antibodies to low frequency antigens out there that have negative Ab screens?  Is there real evidence that those "antibody responders" make more antibodies to low freqs or do we just assume that they do?  I will say that the only patient I have ever seen have a transfusion reaction to one of these was someone with multiple antibodies and the tech missed the incompatibility of a Cw (I think) in the AHG xm when he did the test ( I don't think he was paying attention.)  We know that we must transfuse some incompatible units due to IS or E XM yet I have not seen any reactions in those cases.

 

 I am not really trying to suggest that we should change our practice of doing AHG xms on patients with antibodies, but I like to explore our reasons for doing such things.  I didn't mean to imply that Galvania was suggesting any of the things she mentioned.  She just got me thinking about these issues and the science behind them.

But aren't they starting to think that there are many people with antibodies to low frequency antigens out there that have negative Ab screens?  Is there real evidence that those "antibody responders" make more antibodies to low freqs or do we just assume that they do?  I will say that the only patient I have ever seen have a transfusion reaction to one of these was someone with multiple antibodies and the tech missed the incompatibility of a Cw (I think) in the AHG xm when he did the test ( I don't think he was paying attention.)  We know that we must transfuse some incompatible units due to IS or E XM yet I have not seen any reactions in those cases.

 

 I am not really trying to suggest that we should change our practice of doing AHG xms on patients with antibodies, but I like to explore our reasons for doing such things.  I didn't mean to imply that Galvania was suggesting any of the things she mentioned.  She just got me thinking about these issues and the science behind them.

 

Fair comment Mabel, and I like the way your mind works in wanting to explore whether or not responders do may antibodies to low incidence antigens, and not just accept the dogma.  Actually though, there is a lot of evidence put forward in the 3rd edition of the Blood Group Antigen FactsBook, usually quoted in the notes towards the end of each section on each antigen (not at the end of each "chapter" - although they are not called chapters).

Quite a discussion!

Like many others above, our policies state that products will not be released for transfusion until all testing is complete, and that testing for patients with allo-antibodies includes a AHG phase. So for us, we would have first called to stop the transfusion.

Otherwise, this would be a serious problem at least policy-wise, and I would think reportable to the FDA. Even though I would agree there was probably no additional risk to the patient.

NOTE: I, also, am skeptical about this "known responder" concept (has nothing to do with this case in my opinion). If there are any papers one way or another on this idea I would appreciate a reference.
Scott

Edited June 13, 201312 yr by SMILLER

I'll do my best Scott.

 

 

Rh negative units that are retyped from a blood supplier do not need to have a test for weak-D

Thank you all for your responses!  If I had a "do-over" I definitely would have called the floor.  I still feel pretty awful about it, so hopefully I will be quicker on my feet next time.  A QA failure from our LIS would have been very helpful.

 

On another note, do you all do extended crossmatches on patients who have received Rhogam (history of, or current passively acquired anti-D)?

Do not feel awful about it. In my experience, the question 'what should I have done' was not the correct question to ask. You did the crossmatch as quickly as possible, and in the circustances, as I have said before, the patient was not at any real risk. What you should be doing, in my opinion, is looking into the reasons as to why your system allowed this blood to be issued without a full crossmatch, look at other procedures, make sure your SOPs are reviewed and if necessary updated, and look to see if the problem was due to lack of communication - if so how can that be improved. You should not have to be 'quicker on your feet'. The system clearly needs improving. Use this incident to go forward and make the necessary improvements. Look at this as a good opportunity to have an overhaul!

 

On another note, do you all do extended crossmatches on patients who have received Rhogam (history of, or current passively acquired anti-D)?

 

We would "honor" a RhIG anti-D as the real thing until it dropped below detectable levels then we forgot about it.  As long as it showed up in the antibody screen we would perform AHG XM. 

We treat RhIG same as John...