SMILLER

Indeed!  Keep up the good work!
Scott

Can you get a copy of the policy from your supplier that they use to validate their shipping containers?  Type up a letter for your pathologist to approve explaining it and give that to your Quality people.  Then if they want something more, ask them to show you the regulatory standard they are worried about.
Scott

My idea was just a guess.  If you come across any clinical reasons for this testing in the future, I would be interested in seeing them here.
Thanks, Scott

Okay Scott, but can either the clinician, or you, tell me what constitutes a "significant increase"?  Surely, the absolute titre is much more significant than an increase?  I am not for one moment decrying an increase, that is certainly important, but we also need to know at what titre the anti-S becomes clinically significant in pregnancy.  In the original report involving fatal HDFN (Levine P, Ferraro LR, Koch E.  Hemolytic disease of the newborn due to anti-S: a case report with a review of 12 anti-S sera cited in the literature.  Blood 1952; 7: 1030-1037) the authors state that the titre was between 64 and 128, BUT, it is very important to remember that this was only seven or so years since the IAT was first described, when the sensitivity of the test was, shall we say, primitive, usually involving tile techniques and an AHG made in sheep, goats, rabbits, etc.  The evidence is, therefore, not 100% reliable.
I would have thought that, in this day and age, it would be much more reliable to monitor any pregnancy by such techniques as ultrasound/MCA Doppler, than by the antibody titre, when we do not know what titre is clinically significant in the first place.

If documentation of proper blood handling for transfusion is not appropriate, I am pretty sure that the inspectors will not care whether it's happening in the Blood Bank in the Lab or in OR.  This is healthcare, after all, and this is my hospital.  
I do think it is worthwhile to try to correct deficiencies.  It make seem like a sisyphean task at times, but one cannot just give up on this stuff just because we "are at the mercy of human beings".  (We should all be used to that by now!) 
I do think that efforts should be concentrated on making things as simple as possible, not only for ourselves, but for those other humans in all the other departments that we work with everyday.  I do think its worth the effort.
Scott

You may want your lab manager to talk to your trauma docs.  I am pretty sure that they are going to want to know that you can provide type-specific blood ASAP before the Blood Bank runs out of O negs.
Scott

Hmmmm.  Unless that particular cell is actually a DCe/--- (which I doubt, as they are disappearingly rare), and so has hemizygous expression, where homozygous expression would be expected, this is a bit of a mystery - unless the RHCE*Ce gene contains either a homozygous mutation, or a double heterozygous mutation - but again, this would be exceedingly rare.
I'll keep thinking, but hope someone else comes up with a more realistic reason!

Most antibodies identified as "anti-C" are, in reality, a mixture of anti-C and anti-Ce (with the anti-Ce portion often being in the majority).  This is because many of the antibody producers are R2R2, sensitised by the DCe or dCe haplotype - not all, of course, but many.  According to my mentor, Joyce Poole, this was true even of monoclonal antibodies that are considered to be "anti-C".  This is why you often get weak reactions with RzRz red cells with most examples of anti-C.
As you are getting variable reactions with your panel cells, it could be that you have a rare example of a pure, monospecific anti-C, or an "anti-C", made in an R2R2 or R2r individual, who has been who has been sensitised by a DCE or dCE haplotype, and that you have an "anti-C" that is a mixture of true anti-C and anti-CE.
All that having been said, I can't see that the above information would necessarily give a reason for your patient's odd reactions, but it might just be one of several reasons.  What those other reasons may be, I don't know!

You may have exchanged your pt by that time - then what type are you giving?   I want a sample ASAP.  I worked in a large tertiary care hospital, we would only give you one O= and then only if you gave us a specimen.  We opened that hospital brand new and set up the rules like blood bank should be run.  It was great - no one could say "we've always done it this way."

You may want your lab manager to talk to your trauma docs.  I am pretty sure that they are going to want to know that you can provide type-specific blood ASAP before the Blood Bank runs out of O negs.
Scott

Well, that is rather what I meant!

I do not see anyone here defending the idea that you need to know, with absolute certainty, where each human blood product goes and who ends up with the transfusion.  Every transfusion is a transplant.  Do we really need to review why we cannot issue products willy-nilly no matter how 'universal donor' they are?
There are several suggestions here already for policies to ID John/Jane Does and the units they receive.  It takes consultation and cooperation between multiple departments; and yes, its going to take some work.  Once implemented, an appropriate system will satisfy regulators without any loss to patient care. (Blaming regulations that may be "inconvenient" when pointing out our deficiencies does little to help our patients.)
Scott

i do not think anyone issues blood based on a previous admission's history.  People are not always who they say they are.
Scott

I agree with Dr. Blumberg that pathogen inactivated platelets are probably safer than the "cultured" platelets and that the psoralin compound used in the process currently approved by the FDA crosslinks DNA/RNA thus preventing proliferation of most organisms and WBCs. However, to my knowledge the FDA has not given blessing for pathogen inactivation to supplant irradiation yet. Reading a copy of the "prescribing information" from Cereus would answer this question.
However, it is expensive, $150-$200 premium on the current cost of the products.
It is not yet approved for pooled platelet concentrate products. (six-pack)
It is not yet approved for three products collected from a single donor (triple product).
It is not yet approved as a 7 day product.
There is about a 5-6 % decrease in the donors that qualify for giving two or three products at a time.  This is because the pathogen inactivation process decreases the platelet count by 5-6%. This means that blood centers will need to replace this number of donors in order to keep up with current product demand.
There are some who suggest the platelet efficacy of these products is diminished at as the product approaches day 5.  Whether or not this is seen clinically, I do not know but this would have a bearing on whether or not the product will be approved with 7 day out-date labeling,
There is a third option that can be entertained by the providers of these products.  That is "delayed high volume culturing".  This process makes it standard to obtain both aerobic and anaerobic cultures from each product.  This process has been used quite successfully in Great Britain to interdict contaminated platelet products. I understand this process would be approved for labeling the product with a 7 day expiration date, without the need for the consignee to do point-of-release testing (Verax).
I believe it is important for hospitals to discuss the product desired with their blood supplier.  Opening the discussion now will make for an easier transition when the guidance becomes final.  We expect to hear from the FDA on this topic later this year.

Signature each admission.  After discussion, this is usually done by a hematologist.  (It is really not that big of a deal "bureaucratically" for us.  Perhaps large medical centers have more turf issues with this type of thing.)
Scott

I believe we do this during the time-out, before any wrist bands are covered up.  
Scott

Pathogen reduction prevents lymphocyte proliferation and thus is practically speaking equivalent to irradiation.  Whole blood platelets are pathogen reduced in some parts of Europe, but the manufacturers have not put forward these methods for FDA approval in the USA.  A serious mistake and waste of resources.  In any case, apheresis platelets carry a higher rate of some transfusion adverse events (TRALI, for example) in French hemovigilance data, so why one would preferentially use pathogen reduced platelets that are single donor rather than pooled whole blood is beyond me.  We used to use 100% whole blood platelets as a socially responsible use of donor resources, particularly as apheresis platelets carry no proven health benefits for patients (donor exposure is a straw man in this instance, given the low risk of infectious disease transmission, and it's irrelevance in the pathogen reduction era).  We are using close to 100% apheresis simply because that's the only pathogen reduced platelet product available.  As I said, a terrible mistake in my view.  But better apheresis platelets than non-pathogen reduced is our decision.  We'd welcome use of whole blood pathogen reduced platelets as a much more responsible use of donor's time and safety given that whole blood platelets are essentially now a wasted, low cost scrap product.  Much less expensive, and we think safer than apheresis platelets for most patients.

Can you get a copy of the policy from your supplier that they use to validate their shipping containers?  Type up a letter for your pathologist to approve explaining it and give that to your Quality people.  Then if they want something more, ask them to show you the regulatory standard they are worried about.
Scott

We have the same set up for basically the same reason - a patient was transfused with no transfusion orders.  However, blood bank only gets notification of the product order.  Also, no specimen collection label will generate if only a transfuse order is placed. 
We had a case where a transfuse order was placed on one patient and a product order was placed for a patient with a VERY similar name on the same floor.  RN came to pick up blood for the patient with the transfuse order and couldn't understand why we did not have it ready.  "Patient was bleeding!!!!!" 
Our transfuse and product orders are going back to being linked together so you can't order one without the other.

Truth is important, but the appropriateness of such a statement should be measured by its usefulness.  
Scott

Glancing at the AABB Standards (31st ed), they only state that incoming products shall be "inspected, tested as necessary" before use.   In our case, we log the temp as "acceptable" for RBC products received from our supplier if they arrive on wet ice.  (and labels are legible, units not leaking, etc.)  Likewise, for FFP, on dry ice, and so on.  This is written into our procedure for checking in blood products.  I do not believe we have ever had to "validate" coolers sent from our blood supplier, although we have to do this with our own coolers used for transport.
Not sure about CAP or FDA regs, they may be more strict.
Scott

Thank you Ward_X, SMiller and Dr. Blumberg for your time and reply.
I Agree with the above: There is so much extrapolation and assumptions involved in the decision to use Low titer O group in Hospital settings.  Like for e.g. the proponents are showing military data as evidence, but the military uses WARM Fresh whole blood.  Secondly, data is about penetrative trauma and whole blood is giving at site or within the golden hour.  Urban hospital settings are so much different.  Third, the proponents claim success of programs at Utah, Pittsburg, Mayo etc. However, so many questions (see below) are unexplored or unanswered. 
 
I agree with SMILLER about practicality of use. If one were to set up Low titer whole blood: 
1). In which scenarios or patients would you use? (trauma or other massive bleed?, penetrative trauma vs blunt trauma, is there a time limit within which it has the best beneficial effect? What sex and age group to use for?
2) What titer is acceptable? IgM and IgG, whether the titers are done in viv from Patients draw or from the unit, whether the titer is historical or done every time the donor donates?
3) what anticoagulant is used for storage....whether titers should be different for different volumes of anticoagulant (dilutional effects?)
4). Leukoreduction?
5). Is old whole blood (>14 days) as beneficial as fresh cold whole blood (1-14 days) or as WARM whole blood?
Too many questions
But the most significant if wish to explore is, How to set up hospital criteria to issue whole blood?
 
Thanks again for you insights and time.
Lablion
 
 

It would be interesting to see the commentaries on that guidance.  Will be a burden for small labs (like mine).

As long as the low titer whole blood is really low titer (say <50 or so; not 200), I don't see any major disadvantage in using low titer group O whole blood for trauma patients of unknown ABO type.  For those of known ABO type, ABO identical is no doubt preferable, whether whole blood or components.  We really don't have any comparative data except in trauma patients of unknown ABO type.  Comparisons of ABO identical components versus low titer group O whole blood for everyone are simply not available in any form, to my knowledge.  Would make a very important and useful randomized trial, but no one seems particularly interested in doing the work and incurring the expense, including the military who have sponsored most of this work.  Lots of assumptions being made, but not much data at present.  We know AB plasma given to group O recipients (about 45% of trauma transfusions) is associated with a significant increase in mortality from Swedish national data, so perhaps group O whole blood, if low titer, may actually be safer than traditional component resuscitation in patients of unknown ABO type.  At least the 45% of patients are group O will be getting ABO identical instead of the 5% now occurring (thanks to our giving AB plasma to everyone).

At the beginning of the testing process, ProVue warns the user with a disclaimer displayed onscreen that hemolysis, icterus and turbidity (wbcs, lipemia) may interfere with reading of a sample.  ProVue takes an image of the gel well and does a gray-scale analysis. The presence of turbidity, hemolysis and icterus would darken the image and prevent analysis due to lack of contrast. 
Byfaith was asking if her current criteria is too restrictive and for options for sample rejection criteria when using automated gel testing.  My suggestion was to let the machine determine sample acceptability.  Using a visual color chart comparision process that was probably developed for manual tube testing ignores the machine's capability to do sample rejection that is more consistent and appropriate for the machine.