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There is a very good reason why "generalists" avoid Blood Bank and transfusion medicine - it's complicated and you need a lot of specific training to do it well. Even today, with a significant level of automation, a warm body is often needed to interpret results and give recommendations. And then add the fact that there is a seemingly endless list of "exceptions", "equivocal", "indeterminate", and other levels of results that confound even a trained (SBB) person, let alone an "every other weekend, third shift" employee.
Cross-training is a must for very small, low volume facilities. No question. However, once work gets to a certain level of complexity and volume, institutions should seriously consider having dedicated staff.
I don't know how "generalists" manage to maintain their legally-required competency levels.

I think this is highly dangerous, and I also think that your Pathologist should tell your "LEAN" department to butt out, if you will excuse the language.
 

Our facility uses MobiLab. This system prints labels after scanning the patient identification band. The specimens are then labeled at the patient bedside when collected.  We have Meditech that uses Bar-coded Transfusion Administration.  Nurses scan the patient ID band and unit identifiers (DIN, Product, and Blood Type barcode labels). If something doesn't match, an error message pops up to return the product to the blood bank.  This system is used for all transfusions except some emergencies (i.e., Massive Transfusion Protocols).  It works very well.
In the past, we used Biologics wristband label with patient ID. These worked like a credit card -- labels were made from embossed plates and attached to specimens -- so I've never used the Typenex bands.  With the Biologics and now our current wristbands, we are able to use the blood specimens that were collected previously for CBCs, etc., for our blood bank work if the specimens were labeled with MobiLab.  There was no reason to have to stick the patient again for a blood bank specimen.  This system works.

The requirement to perform a donor retype also plays into whether or not the LIS is used for electronic compatibility testing.
AABB 5.16.2.4  The system contains logic to alert the user to discrepancies between the donor ABO group and Rh type on the unit label and those determined by blood group confirmatory tests and to ABO incompatibility between the recipient and the donor unit. *
*FDA Guidance for Industry: Computer Crossmatch"

The requirement to perform a donor retype also plays into whether or not the LIS is used for electronic compatibility testing.
AABB 5.16.2.4  The system contains logic to alert the user to discrepancies between the donor ABO group and Rh type on the unit label and those determined by blood group confirmatory tests and to ABO incompatibility between the recipient and the donor unit. *
*FDA Guidance for Industry: Computer Crossmatch"

The requirement to perform a donor retype also plays into whether or not the LIS is used for electronic compatibility testing.
AABB 5.16.2.4  The system contains logic to alert the user to discrepancies between the donor ABO group and Rh type on the unit label and those determined by blood group confirmatory tests and to ABO incompatibility between the recipient and the donor unit. *
*FDA Guidance for Industry: Computer Crossmatch"

We retype the units as they come in because like CSP0102, I have personally found units mislabeled at the blood center, so better safe than sorry I like to say.

I highly recommend having a separate product build for convalescent plasma - enough so that it clearly distinguishes the order from a routine thawed plasma product.  If you don't,  beware of the possibility that a random donor plasma can be substituted for convalescent plasma especially if you don't have a lot of COVID19 patients receiving this product.

We have added the AABB attestation statement regarding the release of uncrossmatched, emergency released blood to an Epic order that is electronically signed.  We still send a form but it is more of a back-up now for those instances where the MD did not sign the form from the OR and once the patient has been transferred, it is virtually impossible to find someone willing to sign the form after the fact.

If the antibody was weak, it could be that there was a combination of a dilution effect from the plasma transfusion and associated IV fluids, but also adsorption of the weak and diluted antibody in vivo by the unit that was K Positive.  If the patient has survived the trauma that brought him/her into the ER in the first place,you can probably expect a bounce back in titre within a couple of days, as the "excess" liquid will be excreted, and the immune system will "gear up" after the boost given by the K Positive unit.  Mind you, sometimes, if the patient is bleeding profusely, the immune system seems to "shut down", in terms of being boosted.

Today, we received notification that our blood supplier will no longer be entering the hospital building. We are expected to meet the courier outside to take delivery of the shipment. Additionally, we will be charged for each of the shipping boxes since they are no longer going to be re-used.  Has anyone else encountered this as part of our brand new CoVID-19 world?

I added a statement about either not transfusing or splitting units for patients that are at risk for circulatory overload and that it was the provider's responsibility to identify patients who are at risk .  We use Epic and after the last JC inspection, transfusion rates were amended to specify urgent, normal or slow rates at the time the transfusion order is entered.

I added a statement about either not transfusing or splitting units for patients that are at risk for circulatory overload and that it was the provider's responsibility to identify patients who are at risk .  We use Epic and after the last JC inspection, transfusion rates were amended to specify urgent, normal or slow rates at the time the transfusion order is entered.

That is very sad.  The final decision should depend upon a clinical discussion between the pediatricians, who know about babies, and the pathologists, who know about the value of the test results.
No one discipline knows everything about everything.

We are a smaller Level 1 Trauma Center, 600 beds, 13,000 transfusions last year with1 Vision.  We do not irradiate or wash blood.  We are lucky in that all techs work only in Blood Bank (which includes the Coag lab).  We like an 8 week training period.

Our typical training period in slightly larger hospital is about 3 months (twice as long as yours). Most of our trainees are recent graduates (MT).

We keep RBC and plasma on our helicopter using the Pelican Credos and a datalogger. Units are changed out every 24 hours or replaced when transfused and they keep extra sets of credo panels in the ER freezer to follow manufacturer IFU.  Dataloggers record temperatures every hour with an audible alarm to the user if the temperatures exceed 6C. Datalogger data is transferred to the Blood Bank for review and retention.  We are looking into keeping units with supervisor units for ground transport in 3 counties but that is still in the works.
If you can install an undercounter BB refrigerator at the airport with Wi-Fi temperature reporting and 7-day continuous chart recording, that may be another route to investigate. I have worked at a facility with remote storage at the heliport that was maintained by both ARC, hospital and air ambulance services.  All have to work together to meet requirements to ensure that blood products are maintained properly.

We recently had baby with strongly positive DAT on cord blood, Mom and baby both Group O, mom had a negative antibody screen at delivery. So,  per policy, did eluate and identified anti-Cw in eluate. Went back and tested mom - who had unidentified anti-Cw demonstrating at delivery.  Our screening cells do not routinely have cell positive for Cw antigen.  Textbook case.
We routinely call baby's location when we have a positive DAT on a cord blood evaluation. This is at the request of the physicians so that they can order a Bilirubin sooner than the routine 24 hrs post-delivery.  This was after many meetings with Risk Management, OB physicians, pathologist, nursing, etc..... This is NOT considered to be a critical value notification.  We call it "abnormal result notification".

I have had this conversation numerous times with Anesthesia manager - do we really have to have 2 people verify? Yes. Stop asking.
As for scanning, we have Epic BPAM which does not function in the OR. OR has their own process that does allow scanning of units during massive transfusion but it isn't perfect. If they scan the units from the cooler and somehow the unit isn't transfused and is returned to the BB, there seems to be a glitch where unit status in Epic thinks the unit was transfused when it actually was not and did not update when returned to the BB.  Later, when trying to scan for another patient, BPAM gives a warning "Unit not intended for this patient".  This statement is an almost guaranteed nurse "freak-out."

I have had this conversation numerous times with Anesthesia manager - do we really have to have 2 people verify? Yes. Stop asking.
As for scanning, we have Epic BPAM which does not function in the OR. OR has their own process that does allow scanning of units during massive transfusion but it isn't perfect. If they scan the units from the cooler and somehow the unit isn't transfused and is returned to the BB, there seems to be a glitch where unit status in Epic thinks the unit was transfused when it actually was not and did not update when returned to the BB.  Later, when trying to scan for another patient, BPAM gives a warning "Unit not intended for this patient".  This statement is an almost guaranteed nurse "freak-out."

Agreed. We had a recent positive DAT on Group O baby born to Group O mom with negative antibody screen. Eluted anti-Cw.  After we went back and tested Mom with Cw + cells, 3+ reactivity.
Actual practice on testing babies varies from hospital to hospital - and I think most is dependent on the volume of deliveries at that hospital and the Blood Bank workload.

Our admit order set includes performing Newborn Evaluation when Mom is group O, no prenatal care history, or history of positive antibody screen.  Almost 100% moms have an admission ABO/Rh type and antibody screen.
If mom has a negative antibody screen, what are we expecting to find when performing a DAT on ABO identical mom and baby? 

I agree with John.  Challenge whenever you think you are in compliance.  I always do - win about 60% of the time.   Many inspectors can't see the forest for the trees.  There are many ways to do things that comply.  Just because the inspector disagrees does not always mean they are correct.   I find this moreso with CAP than AABB but sometimes the latter exude hubris (doesn't mean you are wrong).  Worse case scenario - you have to update something.  AND NEVER ARGUE W THE FDA.  I've seen those folks go to great lengths to find a needle in a haystack if you give them a hard time.  I won't elaborate here but . . . take our word for it.  Besides, they can take you out in handcuffs if they think you deserve it.  (there is an enforcement arm).  Good luck.  You'll do fine.
 
 

It is important to remember that inspectors are human and as John says, they can and do cite things because it's not how they do it. Don't take it personally. Their way may give you a good idea for improving your way. At the same time, don't be afraid to challenge a citation if you feel that you've met the intent of the standard and can prove it.
I definitely don't recommend arguing with an FDA inspector - you are probably not going to win.

You don't need to keep those records about irradiation.  You are not performing it.
As an inspector I almost always look at standards which I have been cited for.  (I always disliked when the inspector said: "I knew I'd have to look really hard to find something in Dave's lab).  That's not my style.  I only dig if what I am finding merits such.
I always look to verify you have corrected any prior deficiencies (these are given to us as part of the packet).
I observe your staff and attempt to correlate what they are doing with what your policy/procedure says they should do.  I also ask your staff (without a senior staff member accompanying me) about their work environment, employer, ability to attend CE programs.
I want to see your quality stuff, especially any reports which you should have generated based on your QP.  If you don't have anything it will be a long day for both of us.
I will want to observe a transfusion or at least speak w a nurse about transfusions.  Nursing training for transfusion and knowledge of reactions - this will be from Nursing Ed/Admin
I don't want to review your procedure manual unless you ask me to look at specific items or you have added something new.  I do want to see your table of contents so I can see what you do - I may take a peek at something there that piques my interest (I may also ask you if I might have a copy if it is something I'd like to bring to my own operation).
There are lots of funny stories but you'll have to be inspected by me to hear them. (actually, most of them are quite sad as they involve citations).
I tell your staff to relax because when I go back to work I do the same thing they do.
 
I was an AABB inspector/assessor for 20+yrs.  Still a CAP Team Leader.