kirkaw

what does the ani-D package insert say as to the interpretation of results?  Even if the pt is Weak D positive only we still called them Rh Positive.  There is some controversy with Rh rxs in gel - but I have never heard of such when tube testing is performed.

When we pooled them together, we changed the date to 24 hours.  We also lost the ability to return them to the supplier if they ended up not getting transfused.
 
We no longer pool them together.

I am not sure what exactly OSHA or JCAHO would say about it, BUT IT SURE LOOKS BAD!  Years ago (back in the last century, people used to eat, drink and smoke-if-you-gotum in the Lab, but those days are long gone.  We do have some posted "clean" areas off the Lab for coffee and such, but food or drink (or even cosmetic application) are banned anywhere near specimens or testing of same.
 
It seems like your institution should already have some Infection Control guidelines for you.
 
Scott

In our policy it states to consult with medical director.  For a small amount, like what is in an Rh positive platelet product, administration of RHIG is simple solution and usually safe.   For larger volumes of Rh positive cells, like a whole unit of blood or more, administration of a large amount of RHIG can produce a transfusion reaction-like situation.  Like John said,   formation of anti D is not an automatic kiss of death.  

But Malcolm, there is a very subtle but important difference between what is "possible" and what is "realistic".  Personally, I would say that going through an exchange transfusion simply to prevent the formation of anti-D is not reasonable but then I'm married to a nurse who has an anti-D along with an anti-K and an anti-S so my view may be a little jaded. Oh ya, the D was provided by the birth of our son.  Our daughter was effected by it to the point of needing a double exchange transfusion which, I should mention, is not quite as dramatic in an infant as it is in an adult.  The daughter is now 31 and has three children of her own.  I relate this to remind folks that having an anti-D is not the automatic kiss of death.  Ok, enough of my semiannual philosophical drivel. 

You can't really give enough Rhogam to counteract the effects of a whole unit of packed red blood cells. I believe one vial covers a 30 ml whole blood bleed.
When our O neg inventory is critical, we give O pos to males and to females >50 years. In the past 3 years, we have not had to give Rh pos red cells to an Rh negative women <50 years.

Not sure if you are still confused about IgM and one's ability to detect it.....
 
Paraphrasing Malcolm; complement is not required to be present for an IgM antibody to bind to it's cooresponding antigen.  With or without complement, the IgM antibody will bind to the antigen which most likely will result in visable agglutination.
 
If detecting hemolysis is your end goal, then yes you would need a source of complement (serum or antibody free "fresh serum") to accomplish that goal.

In my opinion,knowledge is power. If you have access to a Technical Manual or some other Immunohematology-type text book, just start reading. Sometimes, lack of knowledge in theory and hamper your critical decision making skills, as maybe happened with your anti-M. Also, if you get a chance, spend some time on day shift and see how those folks handle antibodies and emergencies. Granted, it will be different on evening shift, but at least you can observe their thought processes and process flow. 
 
I am a supervisor at a non-trauma center community hospital and my techs call me at night, on weekends and when I'm on vacation. I'm more knowledgeable on day to day stuff than our pathologist. But I also TALK to people and see if there's any learning opportunity that they need to make them more confident, whether that's doing an in-service with me, having me work with them for part of a shift or having them join us on day shift. It's a coordinating effort but well worth it. I want my techs to be confident and one of the better ways to do that is teach them where to find the information they need and how to make good decisions.

My main problem is identifying who is a Sickle cell patient.  If the Hematology department next door (Our hospital is around 200 beds.) doesn't clue me in, I have no way of knowing that I am working with a new Sickle cell patient.  How does everyone else deal with this?  We are getting more Sickle patients every year.  We typically do not see a diagnosis with an order, and have to go out of our way to see an admitting diagnosis, which may only be "anemia."  Right now we are checking with our Hematology department and/or the patient's nurse to let us know.   I would like to set up a protocol to handle this and wonder if anyone else has some guidelines.
 

We report the antibody screen as positive. If there are no reactions at all in the panel, and we suspect a false pos in the screen, we result the panel as negative. If the panel shows up with some weak positives that don't match anything, and everything is properly ruled out, we report it as "clinically significant antibodies ruled out".

In my opinion,knowledge is power. If you have access to a Technical Manual or some other Immunohematology-type text book, just start reading. Sometimes, lack of knowledge in theory and hamper your critical decision making skills, as maybe happened with your anti-M. Also, if you get a chance, spend some time on day shift and see how those folks handle antibodies and emergencies. Granted, it will be different on evening shift, but at least you can observe their thought processes and process flow. 
 
I am a supervisor at a non-trauma center community hospital and my techs call me at night, on weekends and when I'm on vacation. I'm more knowledgeable on day to day stuff than our pathologist. But I also TALK to people and see if there's any learning opportunity that they need to make them more confident, whether that's doing an in-service with me, having me work with them for part of a shift or having them join us on day shift. It's a coordinating effort but well worth it. I want my techs to be confident and one of the better ways to do that is teach them where to find the information they need and how to make good decisions.

I agree and disagree with Terri - you can make a case that the units were stored correctly.  The feds would say you did not follow procedure.  I'd hate to have to defend it in court as juries are notoriously ignorant.  Better to eat them and use the incident as a means for better compliance with regulations.  The lost $$$ may or may not concern your administration.  Try billing them to the O.R.
 
I have a sporadic day when my BB temps are missed (maybe 2x/yr).  I document that the chart is fine and no alarms sounded; we are staffed 24/7.  Haven't had a problem with inspectors on this, even the feds . 
 
I really have a problem with OR refrigerators - there is no way to document that the units haven't been removed and then returned to the refrig.  You can put the temp monitors on them.  I have been that route in the past and the units always came back as compromised.  Administration always backed the OR even when we put parallel monitors on units we kept in the BB to prove that they were viable.  I've also seen residents just taking blood out and hanging it - paperwork be damned!!
 
This is one example of why the FDA does not want the Red Cross to accept returns after distribution - ARC can't vouch for the the maintenance of storage compliance when the blood is not under their control.
 
A lot of words but no real help to you I'm sure. 

I believe Goodchild is correct based on our JC inspection last year. As an MT with many years of experience, I only qualify as the general supervisor and I think I qualify as a technical consultant based on CFR 493.1411, but for high complexity labs, which immunohematology (BB/TS) is always considered, you must have a technical specialist who is an MD.
 
We have crafted our job descriptions, including those for medical directors very carefully. What was confusing to us, was transitioning to the terminology that CLIA uses. The person we call our Lab Director is not really the lab director because of CLIA requirements. The person they call lab director is actually the lab medical director.
 
As for my question about MLT versus MT, I agree that there are many MLT's that are at least as competent as MT's. BUT I have found that some recent graduates from MLT programs are lacking so much theory that their critical thinking skills are poor. It's like I have to re-do their clinical rotation education and that is very time consuming. I think that resources are shrinking and programs are having a hard time finding hospitals that have the time and personnel needed to teach students. Therefore, the quality of the clinical rotation is decreasing, making the initial training/competency needs for these new graduates tremendous. I am worried about the destiny of our profession from that stand-point. 
I was just wondering if other folks had had that experience.

I retrieved that from http://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5#se42.5.493_11449
It doesn't show any other acceptable qualifications for technical supervisor for immunohematology laboratories.
 
What you refer to sounds more like a "general supervisor." All qualified testing personnel with two years of experience are qualified to be general supervisors according to CLIA.
 
For moderate complexity laboratories there's also a 'technical consultant.' Where you would need a bachelor's degree and two years of experience.

§493.1449   Standard; Technical supervisor qualifications.
The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical supervision for each of the specialties and subspecialties of service in which the laboratory performs high complexity tests or procedures. The director of a laboratory performing high complexity testing may function as the technical supervisor provided he or she meets the qualifications specified in this section.
(a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and
( b  ) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor—
(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification.
...
(q) If the requirements of paragraph ( b  ) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must—
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and
(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology.

Currently we have both MLTs and MTs in the Blood Bank but we are transitioning to MTs due to changes in NYS licensure concerning the CLIA need for technical supervisors in high complexity testing areas (like BB).

Hi Kirkaw, there is a topic in the 'Off Topic" section that will answer some of your questions.  http://www.pathlabtalk.com/forum/index.php?/topic/7817-mlt-vs-mls-in-the-blood-bank/
 
In our lab we have mostly MTs but some MLTs.  At this time, all persons who work in BB are MTs.  We have had MLTs in the past and I would say some were a success and some were not.  The time training for us is sometimes longer depending on experience and willingness to learn. 
 
We do take MLT and MT students on clinical rotations.  Typically MLT students are here for only 2 weeks and we cover everything because at our facility, MLT's are expected to function in BB the same as an MT except they cannot be in charge.  We do not cover adsorptions becasue we do not do them here.  Those would go to a reference lab. 

In my opinion,knowledge is power. If you have access to a Technical Manual or some other Immunohematology-type text book, just start reading. Sometimes, lack of knowledge in theory and hamper your critical decision making skills, as maybe happened with your anti-M. Also, if you get a chance, spend some time on day shift and see how those folks handle antibodies and emergencies. Granted, it will be different on evening shift, but at least you can observe their thought processes and process flow. 
 
I am a supervisor at a non-trauma center community hospital and my techs call me at night, on weekends and when I'm on vacation. I'm more knowledgeable on day to day stuff than our pathologist. But I also TALK to people and see if there's any learning opportunity that they need to make them more confident, whether that's doing an in-service with me, having me work with them for part of a shift or having them join us on day shift. It's a coordinating effort but well worth it. I want my techs to be confident and one of the better ways to do that is teach them where to find the information they need and how to make good decisions.

I report a lot each year, there really isn't any harm.  FDA is not keeping a tally of how many reports you make and swooping in to grill you about them - just my opinion.
 
From what you reported, I don't think this is reportable.  Did you document everything correctly on the products that left the blood bank?  Was the decision to transfuse based on paper records and were they properly reviewed and was this review documented?

Unfortunately, yes.  We recently had to register for the same reason.  If you mix two different products you are essentially making a new product (or at least I was told).  We even emailed AABB to confirm and they said yes.

Sounds like you made really good decisions but I agree with a couple things the other folks above talk about:
1. As a new BB tech, you'll need more backup and support.
2. Keep learning; knowing that Anti-M is usually not a big deal could have been a little calming for you.
3. When someone is truly exsanguinating, you can safely ignore antibodies until they stop bleeding. As they say "incompatible blood can be fatal, but death is always fatal".
If you never have knots in your stomach again, you may not be a good Blood Banker. We will never be perfect, and it's the adrenaline rush that you get with cases like this that keep you learning and also remembering why you work in this crazy field. Not too many people get to go home and say "I helped to save someone's life today".

In my opinion,knowledge is power. If you have access to a Technical Manual or some other Immunohematology-type text book, just start reading. Sometimes, lack of knowledge in theory and hamper your critical decision making skills, as maybe happened with your anti-M. Also, if you get a chance, spend some time on day shift and see how those folks handle antibodies and emergencies. Granted, it will be different on evening shift, but at least you can observe their thought processes and process flow. 
 
I am a supervisor at a non-trauma center community hospital and my techs call me at night, on weekends and when I'm on vacation. I'm more knowledgeable on day to day stuff than our pathologist. But I also TALK to people and see if there's any learning opportunity that they need to make them more confident, whether that's doing an in-service with me, having me work with them for part of a shift or having them join us on day shift. It's a coordinating effort but well worth it. I want my techs to be confident and one of the better ways to do that is teach them where to find the information they need and how to make good decisions.

Let's answer question # 2 first. In any given unit of donated blood, the red cells are of all ages, new and older. So, since the life span of the RBC in the circulation is approximately 90 days, "recently transfused" means that there is a possibility of donor red cells still in circulation in the patient - therefore, foreign antigens are present that could elicit an antibody response up to 90 days (approx.).
Question #1 - I think you were correct in requesting another antibody work up. Especially with the severe drop in Hgb. If a patient has been recently transfused - with in 3 months, the specimen is only good to work with for 4 days - the day it's drawn plus 3.
Assuming you don't do antibody work ups at your hospital, I believe this patient needed an additional work up at the reference lab.
The 3 month rule is because the body can form an antibody to a foreign antigen at any time that foreign (donated) red cells are actively in the patient's circulation.
I hope that helps, and I'm sure my reference lab colleagues will have more to say
Liz

We have a limit of thirty minutes for everything.  Not sure what it is based on, but the main reason is that if a product is outside of proper temp monitoring for more than thirty minutes, we do not want to re-issue it,  The only continuously monitored storage for blood products for our hospital is in the BB.
 
Coolers for OR or ER are issued differently so that we can return those products to inventory or whatever as long as the temps are properly verified when they are returned.
 
Scott

AABB 5.11.2.1: "The completed label shall be affixed to the tube before the person who drew the sample leaves the side of the patient."
 
CAP TRM.40230: "All blood samples for compatibility testing are labeled at the time of specimen collection in the presence of the patient with..."
 
And as Malcolm says, even if it weren't against the standards, it's a very bad idea. So you need to:
 
1. Have your phlebotomy procedure state the above (nursing, lab, docs, phleb team, whoever draws specimens).
2. Have your blood bank P&P say you won't accept specs that aren't labeled as above (like the bags).
3. Why not put it into your hospital's transfusion policies as well, approved by the medical staff. Then you can always point to it and say "It's not just us picky SOBs in the lab who say that, it's Hospital Policy". (You don't have to tell them that you wrote it.)
 
I have to say our lab will accept some specs "in the bag" but only very specific ones (timed blood draws like drug peaks, surgical specimens) that cannot be reobtained. Someone signs an affidavit.