Rapundaa

Scott- What methodology are you using (gel, solid-phase?) We see a lot of equivocals with solid-phase and it can be very frustrating to weed through the reactivity to discover if a clinically significant antibody is there. We also see more equivocals in certain categories of patients (pregnant and some auto immune disease states). And as Malcolm has stated we have seen some of these equivocals become actual an actual E, C, Jka and several others!
Sometimes going to an alternate method (we go from solid-phase to gel) can help because a patient may have a lot of non-specific reactivity in one method and none in another.
Not the most definitive answer but we share your pain!

Same here since about the same year.

We also use in IgA deficient situations. And one time with a patient who had presistent txn rxn (rigors and SOB) with no known antibody issues.

We considered doing this recently but because we are FDA inspected we didn't want to get into the whole "home made reagent" issue. There are a lot more hoops to jump through unlicensed sera.

We gave up our RhIg about 10 years ago. It's stored in pharmacy. After the work is completed in the LIS we order the RhIg in PowerChart (the hospital's Cerner program) which prompts Pharmacy to issue. We can use one or more doses as needed. It's given an obscure pneumonic to keep the physicians from being able to locate it and order it without the appropriate blood bank work first.

I'm not entirely sure what you are asking...
But why was antibody identification not done in solid-phase?
Kidd antibodies are known to love the solid-phase environment, gel not so much. We have had numerous examples of Kidds that react in Capture and not in gel during our validation testing and since.
It is always a best practice to be performing your identification in the same method as your screening. And that would extend to crossmatches as well.

I'm not entirely sure what you are asking...
But why was antibody identification not done in solid-phase?
Kidd antibodies are known to love the solid-phase environment, gel not so much. We have had numerous examples of Kidds that react in Capture and not in gel during our validation testing and since.
It is always a best practice to be performing your identification in the same method as your screening. And that would extend to crossmatches as well.

The following are our criteria for performing a KBT:
Order a KBT on an Rh-negative obstetrical patient for any of the following:
post-delivery Fetal Screen test is positive,
trauma during pregnancy (ordered by the physician),
mother had a vaginal bleed, fetal death, terminated pregnancy, amniocentesis or CVS at > 20 weeks gestation,
mother had a version procedure, and/or
neonate is Rh-negative with a positive or invalid Weak D test, or Rh cannot be determined.
At less than 20 weeks we issue one dose of RhIg without further testing, other than the type and screen.
 
CarrieM has nicely summarized the use of the Immucor FMH RapidScreen if that is the kit you are using.
 
Additionally at delivery, we use an on-line calculator recommended by the AABB to determine the amount of RhIg to be given based on the mothers height/weight:
W:\AB\Bloodbank2\CAP AABB RhIG calculation\RHIGCALe.zip\

The following are our criteria for performing a KBT:
Order a KBT on an Rh-negative obstetrical patient for any of the following:
post-delivery Fetal Screen test is positive,
trauma during pregnancy (ordered by the physician),
mother had a vaginal bleed, fetal death, terminated pregnancy, amniocentesis or CVS at > 20 weeks gestation,
mother had a version procedure, and/or
neonate is Rh-negative with a positive or invalid Weak D test, or Rh cannot be determined.
At less than 20 weeks we issue one dose of RhIg without further testing, other than the type and screen.
 
CarrieM has nicely summarized the use of the Immucor FMH RapidScreen if that is the kit you are using.
 
Additionally at delivery, we use an on-line calculator recommended by the AABB to determine the amount of RhIg to be given based on the mothers height/weight:
W:\AB\Bloodbank2\CAP AABB RhIG calculation\RHIGCALe.zip\

Unless your kit specifies it can be performed with an unknown fetal Rh type....  Ours  (Immucor FMH RapidScreen) states that it can only be performed after delivery of all products of conception (so not after an obstetrical event mid pregnancy) and only on a known D negative mother and recently delivered known D positive child (but not a weak D infant). 

We also use the Sorvall CW2+ and have issues with the we cell button and overall a very wet interior at the end of a 4-wash cycle. But in that we only use it for DATs and LISS or saline workups (3rd and 4th priority in methods of testing) I doubt we will replace it soon.

We are using the Swisslog system and have for about 10 years. In general things go well but the system can get backed up during peak times of the day and tubes may not leave the station as quickly for OR and ER as we would like.
If we are sending blood for a massive txn we try and encourage them to pick it up in a cooler so they have ice and they get all the products at one time, eliminating the problem that some may not get removed from the station where they arrive.
Our carriers are for blood transport are foam padded so we have had to place notes in the tubes to remind staff not to remove the liners before sending units back (to avoid hemolysis). But it's a constant battle because other areas think the only was someone will open a tube is if they can see that there is something inside of it and so they remove the liners (and sometimes discard them). We now keep a supply of extra liners in the Transfusion Service so we can reline the tubes as needed.
Because with the pneumatic tubes the units are no longer delivered on ice, it took some RN education to get them used to the idea that they need to have everything in place (consent, IV, pt temp) to basically be ready to start the unit as soon as it arrives (or return to us in 20 min).
All in all its been a very efficient method. But when it goes down for contamination or service issues finding enough messengers to run the units becomes a challenge now!

We also charge as "bill only" using the IRL charge sheets. And as mollyredone said "if you don't charge then CMS reimbursement will never change!

We also use Helmer Cleanbath (and have for quite some time) and we thaw a lot of plasma daily. The water bath gets changed monthly and barring broken units leaking out of their cover bags it lasts well for the month.

Interesting patient #2 this month.  A multiple myeloma patient who had no history had all testing positive in Gel, including the  Auto control.  Expecting a Warm auto we sent the specimen to the reference lab.  Again, they sent it further to the American red Cross.  They discovered a new medication on the med list was a medication that pretty much interfered with all blood bank testing except Immediate spin crossmatches.    Darzalex is the name of the drug.  The bulletin is below from the AABB.   So, while the patients are on this drug, our reference lab will have to perform the antibody screens for us. 
 
 
 
Association Bulletin #16-02
Date: January 15, 2016
To: AABB Members
From: Donna M. Regan, MT(ASCP)SBB—President
Miriam A. Markowitz—Chief Executive Officer
Re: Mitigating the Anti-CD38 Interference with Serologic Testing
Summary
A new class of therapeutic agents for multiple myeloma, CD38 monoclonal antibodies, can result in interference with blood bank serologic tests and thereby cause delays in issuing Red Blood Cell (RBC) units to patients receiving these agents. To minimize these delays, hospitals should set up procedures to inform the transfusion service when patients start receiving these agents. Considerations for the transfusion service, both before and after initiation of anti-CD38 therapy, are detailed below.
The AABB Clinical Transfusion Medicine Committee has developed this bulletin to provide background information and guidance to members regarding anti-CD38 interference with serologic testing. The bulletin includes recommendations for its prevention and treatment.
Association Bulletins, which are approved for distribution by the AABB Board of Directors, may include announcements of standards or requirements for accreditation, recommendations on emerging trends or best practices, and/or pertinent information. This bulletin contains information and recommendations. No new standards are proposed.
Background
CD38 monoclonal antibodies are a new treatment for multiple myeloma
CD38, an integral membrane protein that is highly expressed on myeloma cells, has been identified as an effective target antigen for monoclonal antibody therapies. In November 2015, the first therapeutic CD38 monoclonal antibody [daratumumab (Darzalex, Janssen Biotech, Horsham, PA)] was approved by the Food and Drug Administration.1 Other CD38 monoclonal antibodies are under development.
CD38 monoclonal antibodies interfere with blood bank serologic tests
CD38 is weakly expressed on red cells. Anti-CD38 binds to CD38 on reagent RBCs, causing panreactivity in vitro.2,3 Plasma samples from anti-CD38-treated patients consistently cause positive reactions in indirect antiglobulin tests (IATs), antibody detection (screening) tests, antibody identification panels, and antihuman globulin (AHG) crossmatches. Agglutination due to anti-CD38 may occur in all media (eg, saline, low ionic strength saline, polyethylene glycol),
1
and with all IAT methods (eg, gel, tube, solid phase). Agglutination reactions caused by anti-CD38 are usually weak (1+), but stronger reactions (up to 4+) may be seen in solid-phase testing. However, anti-CD38 does NOT interfere with ABO/RhD typing or with immediate-spin crossmatches.
Other notes on anti-CD38 serologic interference:
 Adsorptions using either untreated or ZZAP-treated cells fail to eliminate the interference.
 Anti-CD38 variably interferes with direct antiglobulin tests (DATs) and antibody identification panel autocontrols.
 Some rare Lu(a–b–) cells are not reactive in the presence of anti-CD38, potentially giving the false impression that the patient has a Lutheran-related antibody.4,5
 Positive IATs can be observed for up to six months after anti-CD38 is discontinued.1,3
 Anti-CD38 may cause a small decrease in hemoglobin in vivo (~1 g/dL), but severe hemolysis has not been observed among treated patients.3,6
Anti-CD38 interference can cause delays in issuing RBCs
If the transfusion service is unaware that a patient has received anti-CD38, the following scenario may occur when the patient’s sample is tested:
1. ABO/RhD typing: no issues.
2. Antibody detection (screening) test: all cells positive.
3. Antibody identification panel: all cells positive (autocontrol may be negative).
4. DAT: positive or negative.
5. AHG crossmatches: positive with all RBC units tested.
6. Adsorptions: panreactivity cannot be eliminated.
This leads to delays in issuing RBCs to the patient. In some cases, the anti-CD38 interference could mask the presence of a clinically significant alloantibody.
Recommendations
To avoid problems with transfusion, hospitals should set up procedures to inform the transfusion service whenever any patient is scheduled to begin taking anti-CD38.
BEFORE a patient begins taking anti-CD38:
 A baseline type and screen should be performed.
 In addition, a baseline phenotype or genotype is recommended.
AFTER a patient begins taking anti-CD38:
 ABO/RhD typing can be performed normally.
 For antibody detection (screening) and identification, dithiothreitol (DTT)-treated cells can be used to eliminate the interference.2,7
o Because DTT treatment destroys Kell antigens, K-negative units should be provided unless the patient is known to be K-positive.
o Antibodies against other DTT-sensitive blood group antigens (anti-k, anti-Yta, anti-Doa/Dob, etc) will not be detectable when the antibody screen with DTT-
2
treated cells is performed; such antibodies are encountered infrequently, however.
Crossmatch
 For patients with a negative antibody screen using DTT-treated cells, an electronic or immediate-spin crossmatch with ABO/RhD-compatible, K-matched units may be performed.
 For patients with known alloantibodies, phenotypically or genotypically matched RBC units may be provided.6,8
o As some typing antisera require the use of AHG, phenotyping should be performed before the patient receives anti-CD38.
o Genotyping can be performed either before or after the patient receives anti-CD38.
o AHG crossmatches with phenotypically or genotypically matched units will still be incompatible.
o Some clinically significant antibodies may be missed with the use of uncrossmatched phenotypically or genotypically matched units, although this will occur infrequently.
 Alternatively, an AHG crossmatch may be performed using DTT-treated donor cells.
 If an emergency transfusion is required, uncrossmatched ABO/RhD-compatible RBCs may be given per local blood bank practices.
Future/alternative approaches to mitigating the anti-CD38 interference
It is possible to neutralize anti-CD38 in plasma and eliminate the interference using either recombinant soluble human CD38 or daratumumab idiotype antibody.2,3 Neither reagent is widely available at this time, and additional validation would be needed. In principle, soluble CD38 could be used to neutralize any anti-CD38, while different idiotype antibodies would be needed to neutralize different CD38 therapeutic antibodies. Finally, antigen-typed cord cells have been used for the antibody screen as an alternative to DTT-treated cells.9
3
References
1. Darzalex package insert. Horsham, PA: Janssen Biotech, 2015. [Available at: http://www.darzalex.com/shared/product/darzalex/darzalex-prescribing-information.pdf (accessed January 7, 2016).]
2. Chapuy CI, Nicholson RT, Aguad MD, et al. Resolving the daratumumab interference with blood compatibility testing. Transfusion 2015;55(6pt2):1545-54.
3. Oostendorp M, Lammerts van Bueren JJ, Doshi P, et al. When blood transfusion medicine becomes complicated due to interference by monoclonal antibody therapy. Transfusion 2015;55(6pt2):1555-62.
4. Velliquette RW, Shakarian G, Jhang J, et al. Daratumumab-derived anti-CD38 can be easily Mistaken for clinically significant antibodies to Lutheran antigens or to Knops antigens (abstract). Transfusion 2015;55(3S):26A.
5. Aye T, Arndt PA, Leger RM, et al. Myeloma patients receiving daratumumab (anti-CD38) can appear to have an antibody with Lutheran-related specificity (abstract). Transfusion 2015;55(3S):28A.
6. Chari A, Satta T, Tayal A, et al. (2015, December) Outcomes and management of red blood cell transfusions in multiple myeloma patients treated with daratumumab (oral and poster abstract presented Monday, December 7, 2015, 6:00 PM-8:00 PM at 57th Annual American Society of Hematology meeting). Blood 2015;26(Suppl):Abstract 3571.
7. Chapuy CI, Aguad MD, Nicholson RT, et al. International validation of a dithiothreitol (DTT)-based method to resolve the daratumumab interference with blood compatibility testing (oral and poster abstract presented Monday, December 7, 2015, 6:00 PM-8:00 PM at 57th Annual American Society of Hematology meeting). Blood 2015;126(Suppl):Abstract 3567.
8. Hannon JL, Caruk B, Clarke G. Serological findings related to treatment with a human monoclonal antibody (daratumumab) in patients with advanced plasma cell myeloma (abstract). Transfusion 2014;54(2S):162A.
9. Schmidt AE, Kirkley S, Patel N, et al. An alternative method to dithiothreitol treatment for antibody screening in patients receiving daratumumab (abstract). Transfusion 2015;55(3S):2292-3.
4

Good set of questions, if I may so say!

We got a list of CPT codes and charges from our reference lab.  We bill them as "Bill only", which means there is no work shown in our computer.  So we charge for additional antibody IDs or DATs as BO DAT and BO ABID ADD.  We also charge for patient and unit antigen typing as BO AG PT or BO AG UNIT.  I haven't heard from anyone that these are not valid charges, but maybe they just don't pay them.  Still, if you don't charge for your work, CMS reimbursement will never change!

We charge for everything done and have separate 'billing codes' that identify which are in-house vs which are reference laboratory. We were also told we can't pass on STAT/import fees, only things related to patient or donor unit testing/processing.

We gave up our RhIg about 10 years ago. It's stored in pharmacy. After the work is completed in the LIS we order the RhIg in PowerChart (the hospital's Cerner program) which prompts Pharmacy to issue. We can use one or more doses as needed. It's given an obscure pneumonic to keep the physicians from being able to locate it and order it without the appropriate blood bank work first.

Well proving that patient dx is almost always helpful... turns out she did have a BMT 20+ years ago. And yes the anti-B rxn was 4+ (not good proof reading on my part).

Well proving that patient dx is almost always helpful... turns out she did have a BMT 20+ years ago. And yes the anti-B rxn was 4+ (not good proof reading on my part).