Sko681

I call that the "baptism of fire".  Just remember that experience is the best teacher.  If you find yourself in such a scenario where you do not feel comfortable or need help with a decision, is there a supervisor or on call person that you can reach out to?  As a newbie there really should be some kind of support for you in these situations. 
 
Just a battle story to share....  we are not a trauma center either and a while ago when I was new,  we had a patient that came in as a trauma and they wanted emergency release.   Blood was issued and then we found out the patient had multiple antibodies.  I believe that one was a Kidd.  Of course, the units that the patient was given were incompatible.  Because "universal donor" is really kind of a misnomer in scenarios like this. I had obviously never been in a situation like this.    I learned a few things after that incident- the first is that we aren't a trauma center. Almost always the patients that we get are not stable enough to go to another hospital which leads me to my next tidbit... if the patient is bleeding so bad that they cannot wait for crossmatching and antigen typing- the immediate risk to the patient of not getting blood is greater than a potential transfusion reaction.  They just need the oxygen. 
 
Since that time we have had this happen on occasion and while it still makes me nervous it isn't that drop in the pit of my stomach anymore.  Don't be discouraged, you will gain the knowledge over time to be confident in your decisions! 

To extend this point, it's not only a "there should be" kind of situation, it's actually federal law that there's support for testing personnel in problem scenarios (obviously this standard can be widely interpreted):
 
CLIA Subpart M
§493.1463   Standard: General supervisor responsibilities.
The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results.
(a) The general supervisor—(1) Must be accessible to testing personnel at all times testing is performed to provide on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director or technical supervisor;

I call that the "baptism of fire".  Just remember that experience is the best teacher.  If you find yourself in such a scenario where you do not feel comfortable or need help with a decision, is there a supervisor or on call person that you can reach out to?  As a newbie there really should be some kind of support for you in these situations. 
 
Just a battle story to share....  we are not a trauma center either and a while ago when I was new,  we had a patient that came in as a trauma and they wanted emergency release.   Blood was issued and then we found out the patient had multiple antibodies.  I believe that one was a Kidd.  Of course, the units that the patient was given were incompatible.  Because "universal donor" is really kind of a misnomer in scenarios like this. I had obviously never been in a situation like this.    I learned a few things after that incident- the first is that we aren't a trauma center. Almost always the patients that we get are not stable enough to go to another hospital which leads me to my next tidbit... if the patient is bleeding so bad that they cannot wait for crossmatching and antigen typing- the immediate risk to the patient of not getting blood is greater than a potential transfusion reaction.  They just need the oxygen. 
 
Since that time we have had this happen on occasion and while it still makes me nervous it isn't that drop in the pit of my stomach anymore.  Don't be discouraged, you will gain the knowledge over time to be confident in your decisions! 

I call that the "baptism of fire".  Just remember that experience is the best teacher.  If you find yourself in such a scenario where you do not feel comfortable or need help with a decision, is there a supervisor or on call person that you can reach out to?  As a newbie there really should be some kind of support for you in these situations. 
 
Just a battle story to share....  we are not a trauma center either and a while ago when I was new,  we had a patient that came in as a trauma and they wanted emergency release.   Blood was issued and then we found out the patient had multiple antibodies.  I believe that one was a Kidd.  Of course, the units that the patient was given were incompatible.  Because "universal donor" is really kind of a misnomer in scenarios like this. I had obviously never been in a situation like this.    I learned a few things after that incident- the first is that we aren't a trauma center. Almost always the patients that we get are not stable enough to go to another hospital which leads me to my next tidbit... if the patient is bleeding so bad that they cannot wait for crossmatching and antigen typing- the immediate risk to the patient of not getting blood is greater than a potential transfusion reaction.  They just need the oxygen. 
 
Since that time we have had this happen on occasion and while it still makes me nervous it isn't that drop in the pit of my stomach anymore.  Don't be discouraged, you will gain the knowledge over time to be confident in your decisions! 

At minimum we do a DAT in addition to visual inspection for hemolysis on the post transfusion sample but I would caution that unless the post transfusion specimen is collected right away- hemolysis can be missed (I have personally seen it happen). 

At minimum we do a DAT in addition to visual inspection for hemolysis on the post transfusion sample but I would caution that unless the post transfusion specimen is collected right away- hemolysis can be missed (I have personally seen it happen). 

QC for panels is not required by any regulatory agency. And I hope they never change their mind.

I am at the mercy of the blood supplier for plts.  Usually all they have are A+ with an occasional O+.  I can get Rh= products if I know in advance and request them (usually).  All the products I get are apheresis derived - we do not consider giving RhIg to Rh= recipients (maybe if they were randoms and bloody).  We are unconcerned with the K typing of the donor.

I also have to caution that not all degrees are created equal.  Be aware that there are ONLINE MLT programs.  Yes, they still have to do clinical hours however they come in starting with such a low knowledge base, that the 2 week required stint in the department falls way way short.  I have seen them come in for rotations and not even be able to pipette.  They have a program where they perform tasks virtually ( like click a button to add reagents).  Its horrible.  I have to admit that those students, I would not hire for Blood Bank based on my experiences. 
 
I do have good things to say about  MLT's though.  I have seen several who were better than many 4 year techs.  I would say proceed with your eyes wide open.   MLT's sometiems get a raw deal in my opinion as in many facilities they are expected to perform exactly as an MT, but with less pay and education. 

Ahhh!  We just had this happen.  The freezer completely died and the alarm failed to go off.  By the time it was discovered, the products were all at -8 and had been out of temp for hours.  We discarded all of the products.  Turns out that engineering knocked a wire loose when working on the motor and our wireless alarm failed to be noticed by security because someone had closed out the program....Needless to say, I was NOT a happy camper. 
 
This also happened about  8 years ago when someone had turned off the alarm. No one fessed up to it.... When dayshift came in all the products were thawed and freezer felt more like an incubator.  At the time, the freezer was located in another department.  We since have gotten a new lab where we actually have room for all of our equipment!

Ahhh!  We just had this happen.  The freezer completely died and the alarm failed to go off.  By the time it was discovered, the products were all at -8 and had been out of temp for hours.  We discarded all of the products.  Turns out that engineering knocked a wire loose when working on the motor and our wireless alarm failed to be noticed by security because someone had closed out the program....Needless to say, I was NOT a happy camper. 
 
This also happened about  8 years ago when someone had turned off the alarm. No one fessed up to it.... When dayshift came in all the products were thawed and freezer felt more like an incubator.  At the time, the freezer was located in another department.  We since have gotten a new lab where we actually have room for all of our equipment!

I included this as part of my ABID policy. If the patient has received Rhogam, we only do the cells with @ in the Ortho panel. We use to call it a Rhogam-D in our old computer system but now it is called a Passive D since that was what was built in the system. We don't require a full crossmatch since it isn't a true antibody.
   I hope this answered all your questions.

And the above reasons is precisely why I have put off ordering new ones.   

You may find the following FDA response of interest:
 
2009 AABB Ask the FDA Transcript
 
"Question 14:  At previous Ask the FDA sessions, the FDA has explained that combining Plasma and Red Blood Cells to create a "reconstituted" Whole Blood for neonatal exchange transfusion is considered manufacturing and requires FDA registration. Is there a threshhold frequency before registration is required (for this or other infrequent occurrences), e.g., if a procedure is only performed 1-4 times per year, is the facility required to register with the FDA for these infrequent activities?
               
MS. CIARALDI:   FDA does require registration for this procedure because the reconstitution of red cells and plasma to make a third product, the Whole Blood, meets the general definition of manufacture in 21 CFR 607.3(d). There is no threshold frequency that is described in any of our guidance documents or regulations, but we feel, if you have established procedures for performing this process, you must register regardless of the frequency. 
                I would like to add a comment on top of that because it just came in right before I came to the meeting and it came in from a field investigator.  There was a concern expressed and I do want to share that with you.  If you are having staff members perform a procedure as infrequently as described in the example on the slide, how will you ensure their competency, consistent with our requirements in 21 CFR 606.20 (b ?  For procedures performed infrequently, there may be a GMP issue with making sure that staff are competent and experienced and knowledgeable about doing these procedures.  It is just something to think about."
 
As a separate consideration, how would you feel having staff (at the bedside as well as in the Blood Bank) performing a procedure on your newborn that they had never or only performed once 10 years ago?  Might vs.should performed are very different!

I wish I had a dime for everytime I wanted to transfuse a patient just so I could get their antibody levels up to a point I could easily identify them!!!  Never did but sure thought about it. 

Yes.
 
Our form that the physician must sign has areas for the following (and the tech checks which box is appropriate):
 
1.  Issuing incompatible blood.
2.  Antibody is present, not ID'ed yet, and crossmatch is compatible.
3.  Pt has history of clinically significant antibody and crossmatch is compatible, but unit has not been screened for antigen.

I will start the ball rolling with how we handle some of the issues you have addressed:
 
1.  Antibody is present, but not ID'ed yet, and crossmatch is compatible:  We have a form that states that the antibody has not been identified, and although the crossmatch is compatible transfusing it does carry some increased risk because it has not been screened for the corresponding antigen.  Ordering physician has to sign the form.  (Pathologist is not usually notified.)
 
2.  Patient has a history of a clinically significant antibody and the crossmatch is compatible:  We have a form that states that, plus the comment that transfusing it does carry some increase risk because it has not been screened for the corresponding antigen.  Ordering physician has to sign the form.  (Pathologist is not usually notified.)
 
3.  Antibody is present, but not ID'ed yet, and crossmatch is incompatible:  We have a form that states that the antibody has not been identified and the crossmatch is incompatible and carries an significant risk of a possible hemolytic transfusion reaction.  Ordering physician has to sign the form.  Pathologist is notified that we are issuing incompatible blood.
 
The above situations are spelled out in our policies/procedure manual.
 
In any of the above situations, if the supervisor or assistant supervisor is present they are consulted and get involved in the situation (to make sure we are doing the best/safest thing for the patient.)  If supervisor or assistant supervisor are not present, whether they are consulted/notified depends on the expertise/experience of the tech involved.  All staff are certainly welcomed to call us at any time, but a few of our experienced techs are comfortable handling the situation.
 
Donna

This happens to be a TJC inspection.  I challenged the citation this morning- I still couldnt understand what she was getting at.   I am at the core lab and she was inspecting one of our 3 off site laboratories.  I will have a different inspector and hopefully we will be able to see eye to eye on this.

I've had some inspectors that get really subjective on the standards and I always ask to call CAP "as a referee" or to get clarification of the standard - most of the time they are able to sort it out over the phone! When in doubt challenge the very same day they are questioning you. Sounds to me like your inspector is trying to understand the intent of the standard but may not be a practicing blood banker or they would know comparing IS XM to IgG crossmatch is not method correlation - I'd show them the technical manual in which explains the definitions of the two types of crossmatches and what they are used for - then hopefully the inspector would understand it's like comparing apples to oranges versus gala apples to golden crisp apples (for example gel AHG XM vs tube AHG XM for which the standard is intended).
 
Just to cover ourselves as far as QC review goes - we wrote in our policy that QC is reviewed and passed and marked down on the daily maintenance record sheet and the medical director signs off on that sheet on a monthly basis - so the Medical Director is essentially reviewing that QC passes on a daily basis. If there was ever a QC failure, we have a seperate procedure for corrective action to document what we did to troubleshoot and when QC ultimately passed and the medical director signs off on all corrective actions documents as well. So maybe that might help for the future. It's absurd that the MD would have to look at every QC reaction on a daily basis!
Good luck!

Personally, I think this inspector is completely over the top, and I agree with you that they are not designed to test the same type of antibodies.
 
You could be really sarcastic, as would I, by telling him or her that you have correlated these techniques, by the fact that all of your patients had survived the transfusions following the use of the techniques!

I agree; this inspector is confused.  I could see if you perform tube AHG and gel AHG crossmatches, you would be correlating the methods.  But you can't correlate the IS to the AHG.

I would be surprised if this guru is currently responsible for the activities of  an active transfusion service.  It is easy to state, "Get it right the first time".  I think the guru's logic is flawed in that it compares apples to oranges!  A lab test result can vary from minute to minute, ABO blood types do not.  Physicians can challenge a lab test result if it doesn't fit with their clinical assessment and request repeat testing or repeat specimen collection.  Not so with a ABO blood type.  How does this work when patients share identities and insurance cards?
 
I would also challenge the guru's logic regarding the inability of donor centers in the United States to guarantee that the blood container ABO/Rh label is correct..  Why can't they "get it right the first time"?  Transfusion Services are required to confirm the correctness of the ABO container label, because the donor center cannot guarantee it is correct. 
 
The electronic crossmatch is based on the logic, Determine the ABO/Rh (donor center) and then verify it (transfusion service). This logic works for both donor units and for patients, "Trust but verify".

We do not do a workup if urticaria alone is identified.  Our transfusion reaction workup form that the nurses fill out actually says "If urticaria alone is identified, the Blood Bank does not need to be notified"   I would think that if the hives were severe suggesting an anphylactic reaction- there would be other obvious signs (hypotension, bronchospasms, etc.).  I think that unless an anaphylactic reaction occurs, transfusing washed RBC's is probalby not necessary (which is what we do).  There is a reference somewhere in the AABB guidelines (Laboratory Evaluation of Transfusion Recations) that specifically says "Urticarial and mild to moderate allergic reactions do not require laboratory evaluation."  This should save you some time and headache!  Hope that helps.

I am somewhat surprised that you "often" see patients with these subtypes as, working in a very large Reference Laboratory, we see no more than about 2 or 3 a year.
 
That having been said, with the advent of avid monoclonal grouping reagents, it is now almost impossible to assign a specific subgroup to an individual, without the use of molecular techniques.  The old way of assigning such subgroups is somewhat defunct, as the reactions we get with these modern monoclonal antibodies are so much stronger than those seen with human-derived polyclonal reagents (and even then, the "strength of the reaction" tended to vary from one laboratory to another, and from one person in a laboratory to another, as the reading was totally subjective).
 
Personally, I would not now attempt to assign a specific subgroup.  As long as the patient is, say, group A, it really doesn't matter if they are A1, A2, A3, Ax or Am.  They can still be transfused with group A1 blood, unless they have an anti-A1 in their plasma that reacts strictly at 37oC, and such an antibody is extremely rare.  If there is any doubt, they can be given group O blood.
 
From the donation point-of-view, again it doesn't matter if the donor has a subgroup of, for example, group A; they are still group A, and, as a consequence, their blood should be labelled as such, so that it does not go to a patient who is group O or group B.

Ebola hysteria is right!  For us (in NY), the DOH has said emergency release O negs and though they didnt specify I would assume AB plasma should they need it.  I did hear of some hospitals investigating the use of gel workstations under a hood.  However, we wouldn't have the room for something like that here.  I would definitly love to hear from someone at Emory or even in Dallas as to what they did (if they are allowed to comment on it).