Ensis01

For red cells, we switch to ABO specific once we've processed a T&S (and a confirmation type on a second sample when not type O). We do that as long as we can (don't want to waste O cells on a non O if I don't have to). 
If the patient is Rh neg, and we had been using Rh pos during the massive, we don't switch back to Rh neg until the massive situation is over. 

T&S on every delivery patient ... so, there's our Rh confirmation of the 'woman in the bed'.
Post-Delivery = Fetal Cell evaluation (currently K-B Stain, that may change).  Period.
n.b. Unless we can prove mom is producing Anti-D, MD wants the Rh-Ig anyway, no matter what.  In fact, we've had an MD want it given even when we CAN prove she's making her own Anti-D.  #MDsalwaysgetwhattheywantevenifitdefieslogic

This flowchart represents our requirements for handling blood components returned unused by Nursing. 
There are three (3) basic elements: 1) Appearance, 2)Temperature, and 3) Time out of storage.  If the visual inspection of the component does not reveal any unusual observation(s) and the component is within acceptable temperature limits and the component has not be out of storage for more than 30 minutes then the blood component may be reissued for transfusion.
1.  Blood component is discarded if the container is spiked or outlet port(s) opened (regardless of temperature or time out of storage).
2.  Blood component is discarded if the container contents are abnormal in color or appearance (regardless of temperature or time out of storage).
3.  Blood component is discarded if the temperature of the blood component has exceed acceptable limits (regardless of appearance or time out of storage).
4.  Blood component is discarded if more than 30 minutes has elapsed since removal from storage (regardless of appearance, temperature or time out of storage). We do not issue in coolers.
If any of the four (4) numbered statements above is/are true, component may not be reissued for transfusion and is immediately discarded into the biohazard trash. No exceptions.
The BBK CLS who receives a returned unit is required to complete this form and use a colored highlighter to trace his/her pathway from the starting point to a termination point.  The completed form is reviewed by the supervisor and filed.
My understanding of the "30-minute" rule is that the temperature of component is ignored if the component has been out of storage for less than 30 minutes.  We do not ignore temperature.  There was an article in the AABB News several years ago that debunked the "30-minute" rule.
We borrowed our 30 minute time limit out of storage from the old rule, but did not validate.  We assume that a blood component returned unused with a normal appearance, within temperature and within 30 minutes of issue may be reasonably returned to storage for reissue.
This process is intended to limit the number of decisions required to be made by a generalist.
 

The real problem here seems to be that they want to blame their own errors onto the laboratory, and think that, if they perform POCT themselves, they can get away with these errors.  If you provide a STAT laboratory for them, unless you lower your standards, WHICH YOU MUST NOT DO, they are still going to be making these errors, and the TAT will not improve - ANT THEY WILL SHIFT THE BLAME BACK ONTO YOUR SHOULDERS.
Are you getting any help whatsoever from your own pathology clinicians?

All common clinically significant antibodies ruled out.  This reports back to the EHR

Our rules regardless of methodology:
K, rule out heterozygous
C, E, rule out heterozygous ONLY when Anti-D is also present.  If no Anti-D, rule out homozygous

I would set up another tube, concurrently, for the 37 and AHG reactions.  

I'm not trying to be funny; but if Ortho requires the lab to QC the panel periodically why do the panels have an expiry date. I mean it has been pointed out in several threads that the manufacturers QC and stability testing and requirements must far exceed what a lab could do or be expected to do. Am I missing something?

I know this post is almost 4 years old, but it was quoted a couple of hours ago and I find the highlighted part interesting.
Not sure how big of a facility you are, or how much you transfuse.  We're decent size, we transfuse about 24 - 28k RBCs a year.  I've been at my current location for 26 years.  That's approaching three quarters of a million red cells we've retyped in my time there.  I recall only one unit we received from a facility that was mislabeled.  That's pretty good evidence that retyping, while required, does not add a lot of value.  The odds that something would go wrong are beyond astronomical.  You'd have to have a mislabeled unit, you'd be on downtime, it would mistakenly get into the retyped area, then it would have to go to a patient where it could cause harm, then the odds that it actually would cause harm are still small.

I agree with Dansket.  There is too much insurance card swapping and sharing going around to rely on a historical type, even if andministration of Rhogam would not necessarily be that harmful.  We require a current type for everything except emergency release/massive transfusion and even then we would like to a specimen sooner than later so we're not pouring out ON for child-bearing females.

I am still astounded that this is still necessary. All UK units are guaranteed so this is not needed. How can you have any faith in your reference centres if you can't trust them to get an ABO correct?

I'm not trying to be funny; but if Ortho requires the lab to QC the panel periodically why do the panels have an expiry date. I mean it has been pointed out in several threads that the manufacturers QC and stability testing and requirements must far exceed what a lab could do or be expected to do. Am I missing something?

An interesting twist ! One could look at it that way.
Red cell products ultimately do deteriorate and that's why they must have an expiration date. Hemolysis is often the first visual clue. However, that doesn't mean that all of the antigens have suddenly become unrecognizable; it just means some of the older cells in the vial have popped. Studies have been published demonstrating that antigens remain stable many days/weeks after official expiration.
Manufacturers do have oodles of stability data - both static (in-house) and following shipping. Typically a unit of red cells that is turned into a red cell product has at least an eight-week expiration. This allows for manufacturing and shipping to the end users who then usually have five-weeks left on the expiration. In reality, those expiration dates could be longer, but the manufacturers deliberately give themselves a buffer period, just in case.
The wildcard in this whole process and issue upon which the regulatory agencies focus is shipping. How do the end users know that something horrible didn't happen to the material ? An unanswerable question. Even though the manufacturers have shipping stability data, they can't possibly foresee and test every odd, weird situation. One could argue that Ortho have less faith in their shipping process than other suppliers, hence the requirement for periodic QC.

Interesting topic.  In just a few posts, it is easy to see there is a variety of ways labs approach the "how often are elutions performed" question and under what circumstances.  I too agree with Malcolm; in the presence of AIHA and a positive DAT, most likely you will get off a panagglutinin every time you perform an elution.  Once this occurs, there is no point in performing additional elutions on a routine basis.
In the patient though who has a positive DAT and is transfused on a regular basis, and has a negative eluate (yes, this does occur) the elution question is a bit different.  Technically, any transfusion can result in the production of an alloantibody that may or may not present itself in a hemolytic fashion.  It is possible to have a "delayed serologic transfusion reaction" that shows no signs or symptoms of a hemolytic process. In this scenario, the idea of not doing an elution on a regular basis because it has never revealed anything in the past, may result in missing a newly formed, clinically significant antibody that is only detectable in the eluate.  Not performing an eluate in this scenario is not without risk and should not ever become "policy" without proper overview of the clinical situation.

The IT department should not be able to NIX instrumentation selection for the lab. If the ECHO is the best fit for your lab then that's what you should go with. I suggest having Immucor Sales Rep get the Immucor IT folks to talk to the hospital IT folks so they can speak the same language and understand what the issues and whether or not they can deal with it until the new W7 version is available.

I'm curious.  What benefit do you see in retesting the same sample?  

We decided to stick with the Safe-T-Vue 10 indicators for our OR coolers.  Our logic behind this decision was our coolers for "storage" are validated to 1-6C and if the units remain in the cooler, we know the temperature will be maintained between 1-6C.  If the units aren't in the cooler, then they are in transport, and the indicator will show any temperature excursions above 10C.  We have had AABB, CAP, and FDA inspections and no one has had an issue with our logic. 

I agree with your logic!

We could show them our antigen typing worksheets so they could see the different lot numbers.  We keep two years of antigrams, although most of anti-sera testing is IS (3%) now, only Fya and Fyb are AHG, which we validated in gel.

Completely agree.  We have something called "the element of uncertainty" (it isn't "element", but it is something similar) that is required by one of our more officious regulators (not that any of them are less than officious), but we struggle with this because, apart from titrations/quantifications and measuring an FMH, I struggle to think of any tests that we perform that are quantitative, rather than qualitative, which means there is no "element of uncertainty" - as long as your controls have worked, but these numpties stil ask for evidence.  You will be surprised to learn that most of the inspectors for this particular regulator have never stepped foot over the threshold of a transfusion laboratory prior to inspection!!!!!!!!!!!!!!!

This topic keeps popping up periodically and I find it both interesting and frustrating.  My personal view, as stated in previous discussions on the topic, is that what ever you do is little more than smoke and mirrors in an attempt to pacify some regulator.  I'm sure that's also why the manufacturer puts such nonsense in their package inserts. They claim specificity for many antigens yet it is acceptable to confirm the reactivity of a select few!!  I'm sure that can be rationalized but it still makes no sense to me.  

What we do is use the current cells for our QC for our antigen typing, using a heterozygous cell as a positive control for whatever antigen we are testing.  That seems periodic to me.

There is no 'good' way to run QC on a panel. In my mind, a better way to control a panel is to look at it and see if it makes sense with the results you get from your antibody screen. However, that doesn't seem to tick the box for QC for an inspector as well as a specific test defined in a policy.
Method comparison is another of those things that we do with questionable results. I run an antibody screen (or ID panel if I can find a patient with a nice antibody and enough plasma to spare) using all the methods we use, get different results from those screens and interpret it as differing sensitivity - something I expect to see. What have I proven by doing it? Nothing much. The results I get are not surprising. Works great for chemistry and hemo but does it give blood bankers information we don't already have/know? I'm still going to use the Echo for my primary method with tube/PeG for backup.
 

I think I'm with you exlimey. We don't do any QC with our Ortho gel panels, other than review every antibody ID within one business day and monitor for trends.

More Devil's Advocate: That only tests the K antigen - a very stable structure. What about other antigens that are more likely to and are known to deteriorate over time - Lea, Leb, Fyb, to name but a few ?
The only value to testing a K- cell against a diluted antisera is to check the DAT on the chosen panel cell, i.e., it's potential to cause a false-positive. You could simply do a DAT instead.
I'm certainly not suggesting that everyone completely phenotype their Screening Cells and Panel Cells each day (or periodically). I'm all in favor of a minimalist approach to this issue, and it appears that similar testing algorithms are acceptable to inspectors. 
I really just wanted to highlight the flaws in this whole concept, from both the regulatory side and that of the users. And.....don't forget.....the manufacturer's of the red cell reagents have a huge amount of stability data.