Teristella

During the majority of my professional life, Blood Bank has read the Kleihauer tests.  I have NEVER understood why this should be so.  It was INCREDIBLY rare to come across a case that was not, to all intents and purposes, negative (or certainly required no more than the "typical vial", as you say).  This meant that those working full time in Blood Bank were most UNLIKELY to be competent in accurately counting a minority of cells on a smear under the microscope.
On the other hand, the Haematology Laboratory staff were used to looking at slides to accurately assess, for example, reticulocytes and, come to that, malaria slides.  I always thought, therefore, that their staff would be much more competent at looking at Kleihauer slides (this, of course, was before reticulocyte counts were performed by automation), but I still think that those who are used to performing a particular test should be the ones who actually perform the tests on a routine basis, particularly in these modern times when the "measurement of uncertainty" is such a popular reason to give "a fizzer".

I have to ask, how many times when the DAT is negative and you can elute the antibody from the babies cells does the infant show symptoms of a significant case of HDN (old guy, old nomenclature) resulting in an exchange transfusion or even phototherapy?  Seems to me you are doing an awful lot of work for little, if any, benefit.  See Malcolm's technical discussion above.  

We use Alba-QC-Chek for Daily and Day of Use QC on ProVue. We put new lot of Alba-QC-Chek into use on Mondays.  If inspector asks for evidence of lot to lot comparision, we would show them Sunday's QC test results on old lot of Alba-QC-Chek and Monday's QC test results on new lot of Alba-QC-Chek.   It is extremely rare for Daily QC to fail on ProVue.

Thanks, Cliff, for the Velcro idea! It took a few hours to get all the old labels off without alarming the poor fridge but I relabeled our shelves this week.

I wasn't questioning the immunology, merely the fact that the average hospital/blood bank is rarely going to encounter a K+k- patient. If "we" are going be really concerned about k- patients in the Dara scenario, shouldn't "we" also be worried about Kp(b-) and Js(b-) patients ? And what about patient with antibodies to Dombrock system antigens ?
I agree that emphasis on giving K- blood to K- patients is well founded, but it appears that a unduly disproportionate amount of concern is being applied to other, rare blood types. I guess we blood bankers are always looking for zebras ? ☺

Why?
From my brief stint in components at a blood supplier, I remember leukoreduction methods being QC'd fairly well. Physicians should be pre-medicating patients and requesting irradiated blood as needed, not double filtering products to some unknown end. How do they even know it's doing anything qualitatively substantial?

We do not use the liquid plasma on 'regular' patients (i.e. non-emergent) due to the following published in the FDA Circular of Information:
There is also a phrase in there stating that liquid plasma may contain viable lymphocytes (i.e. risk of GvHD).
 
Edit: This is assuming you are using the liquid plasma, never frozen (26 day expiration), and not thawed plasma (5 day).

I have not used it, but there is a follow button at the top -- I believe that does something? I'll follow this thread to see what happens.
 
Edit: You can have the site email you reminders that the topic exists, which I chose not to do; then if you click your name at the top, to get the dropdown to go to your profile, there's an option to 'Manage followed content' which gives a list of all followed threads. Perhaps not ideal but maybe a temporary solution?

Enzyme-treated cells can be very useful in the hands of expert serologists who know the pros and cons of their use. Routine use by front-line techs is probably ill-advised.
In this case, some level of feasibility testing might be useful before switching to an enzyme-treated panel, but I would hesitate to call it "validation". Each facility should determine if such a panel is useful to them, or if it would cause more problems that it would solve.
As I mentioned in earlier in this thread - I believe these are FDA-license reagents and they do not require validation.

I can't agree more, with both of your posts.

My personal opinion - no validation required.
You are switching from one FDA-licensed product to an equivalent. Unless you plan to use it in a fashion contrary to the manufacturer's instructions it's a business decision rather than one of quality or performance.
If you have an internal policy that directs you to "validate" in these situations, you should change that policy. Anything that an end user does to "validate" a commercial, FDA-licensed red cell panel is dwarfed by the process involved to get these products to the market. 
Perhaps more important is that the replacement product suit your facility's specific needs. The typical antigenic make-up of the panel you select should reflect your particular testing requirements. For example....if you have lots of patients with anti- D, a panel with lots of D+ cells my not be very useful.
 

A validation is not necessary in my opinion.   Would run a few patient samples with current and new panel and results should be comparable or better than the current to be acceptable.  

We used the Emerge for our trauma bay at my previous hospital... it worked well as long as the nurses were trained, but our trauma department had difficulties with high turnover. If they aren't trained well they ended up panicking and opening the fridge and not scanning out the units. As long as there was only one trauma at a time we could track everything easily; if not, and we were not familiar with the nurse working the kiosk, we would go down to manage it ourselves. A lot of it did depend on the physicians as well, some were very vocal about getting blood quickly and would bully the nurses into shortcuts.

Anecdotal evidence, but at my previous facility we routinely modified everything to 5 day with no variances.
On the other hand, the VA lab I'm at now has an FDA license number and is FDA inspected just to thaw products. I'm guessing this was a requirement for some kind of product modification they did in the past and it's just been left alone.

The FDA has put it in the same category as drugs, and requires a pharmacist review. Probably not in the UK though.

Actually it is a blood derivative.
In the USofA blood is considered a drug by the FDA - to get better remuneration for his staff one of my previous lab mgrs had all the blood bank staff assigned to the same pay scale as the pharmacists - pretty ingenious I thought.

Copying a reply I made to another post concerning this, and I'll add some more info as well.
We used the Haemonetics Emerge kiosk for our trauma bay at my previous hospital... it worked well as long as the nurses were trained, but our trauma department had difficulties with high turnover. If they aren't trained well they ended up panicking and opening the fridge and not scanning out the units. As long as there was only one trauma at a time we could track everything easily; if not, and we were not familiar with the nurse working the kiosk, we would go down to manage it ourselves. A lot of it did depend on the physicians as well, some were very vocal about getting blood quickly and would bully the nurses into shortcuts. The Emerge will let nurses scan a patient label to link products to (they have to scan it once for each type of product and then scan out the required number of units). This was not interfaced to our LIS but we could find the patient name based on the account number they scanned. The computers in the blood bank had software that linked to the kiosk and would alert us when the fridge was opened, so we could monitor what was removed.
With the Emerge you have to program what types will be in the fridge, and as I recall, they did not allow for more than two choices per product type. That meant when we first started storing plasma there, the nurses had to select plasma, then select AB pos or AB neg. You could not remove the Rh on plasma and it drove us insane. We would make every effort to store only AB pos there, and train the nurses to only select AB pos... but the AB neg option was still there, and if they selected it, the kiosk informs them there are no units available and to contact the blood bank! You can imagine this got us a lot of frantic phone calls... we also ran into this problem when we switched to using group A liquid plasma and we would have to request only Rh pos from our supplier to try to avoid this problem.
Eventually we were storing 2 O neg packed cells and 6 A liquid plasmas, plus 2 pediatric units on the bottom shelf. We kept two thawed AB plasmas in the blood bank for pediatric use which they were to call us for.
The Emerge also does not have any checks in place to question the staff of the gender/age of the patient... for this reason my blood bank supervisor chose not to store O positive units in the kiosk. We surveyed a lot of hospitals in our system and many did keep O positive in the fridge. I was personally of the opinion that we needed O positive units down there, and had suggested that we get two bins, one pink and one blue, with signs on the top describing the indications. The trauma docs did not want the responsibility of telling the nurses operating the kiosk which type to grab so it was up to the RNs. We were a level 2, however, so the majority of our traumas were using O positive. If you were a level 1, I think you'd have to decide this for yourself -- do you let them figure it out or only give them the option of O negative? We were always so short on O negatives that we reduced the number of units in the fridge to 2, so that when they all panicked and transfused them to a 70 y/o male (they were supposed to call us for O positive), we wasted fewer Rh negs! They rarely gave products from the fridge unless it was a massive transfusion, and we would bring them the O positive (we kept 6 pre-labeled in the blood bank) with a platelet for their first batch, to use with the plasmas from the fridge. They could move the plasmas into the cooler we bought with the O pos and haul it off to CT or OR or wherever.
This seems awfully long so I really hope it makes a little bit of sense. Please feel free to ask any questions, I probably missed some important points.

We used Meditech and it worked fine. As I said, it was not interfaced.

Copying a reply I made to another post concerning this, and I'll add some more info as well.
We used the Haemonetics Emerge kiosk for our trauma bay at my previous hospital... it worked well as long as the nurses were trained, but our trauma department had difficulties with high turnover. If they aren't trained well they ended up panicking and opening the fridge and not scanning out the units. As long as there was only one trauma at a time we could track everything easily; if not, and we were not familiar with the nurse working the kiosk, we would go down to manage it ourselves. A lot of it did depend on the physicians as well, some were very vocal about getting blood quickly and would bully the nurses into shortcuts. The Emerge will let nurses scan a patient label to link products to (they have to scan it once for each type of product and then scan out the required number of units). This was not interfaced to our LIS but we could find the patient name based on the account number they scanned. The computers in the blood bank had software that linked to the kiosk and would alert us when the fridge was opened, so we could monitor what was removed.
With the Emerge you have to program what types will be in the fridge, and as I recall, they did not allow for more than two choices per product type. That meant when we first started storing plasma there, the nurses had to select plasma, then select AB pos or AB neg. You could not remove the Rh on plasma and it drove us insane. We would make every effort to store only AB pos there, and train the nurses to only select AB pos... but the AB neg option was still there, and if they selected it, the kiosk informs them there are no units available and to contact the blood bank! You can imagine this got us a lot of frantic phone calls... we also ran into this problem when we switched to using group A liquid plasma and we would have to request only Rh pos from our supplier to try to avoid this problem.
Eventually we were storing 2 O neg packed cells and 6 A liquid plasmas, plus 2 pediatric units on the bottom shelf. We kept two thawed AB plasmas in the blood bank for pediatric use which they were to call us for.
The Emerge also does not have any checks in place to question the staff of the gender/age of the patient... for this reason my blood bank supervisor chose not to store O positive units in the kiosk. We surveyed a lot of hospitals in our system and many did keep O positive in the fridge. I was personally of the opinion that we needed O positive units down there, and had suggested that we get two bins, one pink and one blue, with signs on the top describing the indications. The trauma docs did not want the responsibility of telling the nurses operating the kiosk which type to grab so it was up to the RNs. We were a level 2, however, so the majority of our traumas were using O positive. If you were a level 1, I think you'd have to decide this for yourself -- do you let them figure it out or only give them the option of O negative? We were always so short on O negatives that we reduced the number of units in the fridge to 2, so that when they all panicked and transfused them to a 70 y/o male (they were supposed to call us for O positive), we wasted fewer Rh negs! They rarely gave products from the fridge unless it was a massive transfusion, and we would bring them the O positive (we kept 6 pre-labeled in the blood bank) with a platelet for their first batch, to use with the plasmas from the fridge. They could move the plasmas into the cooler we bought with the O pos and haul it off to CT or OR or wherever.
This seems awfully long so I really hope it makes a little bit of sense. Please feel free to ask any questions, I probably missed some important points.

And labeled with Rh/K typing, right? Very jealous!

OUCH -- that hurts. We were actually told by our supplier that rotating platelets was not efficient for them, and they would rather us let them expire on our shelf and give us credit. Does not seem like very good stewardship of the blood supply to me, but it was their choice.
I think something like this would be really valuable at my current facility considering we are keeping 6-8 platelets on our shelves at a time. We have heavy users in trauma, oncology and cardiac cases. Some nights we throw away four or five. Unfortunately today is my last day here but I'll be keeping an eye out for info to send to my supervisor about this.

We keep it in the fridge because the storage temperature is 2-8C on the package insert. It is diluted and warmed to 37C when time to use it... I think you are incorrectly assuming every fetal stain kit is the same.
You seem to be misinterpreting the use of the screening kit. The fetal screen kit does not tell you how much anti-D to give at all, it simply screens for the presence of a bleed. As I said, they are used for two different situations.
 
Here, I will attach the package inserts for the two tests. Based on the times for each step in the stain kit, it can easily take 30 minutes.
Fetal stain kit - 285.pdf
Fetal screen kit - 3047.pdf

Thanks, Cliff, for the Velcro idea! It took a few hours to get all the old labels off without alarming the poor fridge but I relabeled our shelves this week.

A fetal screen is essentially adding a weak anti-D to patient cells and incubating; the Immucor kit is a 5 minute RT incubation now, I believe. Then wash and add indicator cells to form rosettes, if the test is positive, and count them.
Far easier than a KB. A lot of things are simple that aren't easy.  I'd take a 15 minute process over a 30 minute one any day, and skip staring through a scope for very long.
Edit: That said, they definitely test for different things! We dumped fetal screens because they too situational for us to stock the kits.

You could always irradiate the blood bag (as well as the blood), while the stupid nurse is holding it!!!