Dawn

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The draft of the 6th edition of the AABB Immunohematology Reference Laboratory Standards is open for comments. It will be posted on the AABB website for 60 days. http://www.aabb.org/Content/Programs_and_Services/Standard_Setting_Activities/propstdirl6ed.htm

We require 3 to rule-out, we would prefer that one of them is homozygous, however with anti-K we allow 3 heterozygous.

In addition to charging for another panel, you can charge for treatment of the panel cells. So an enzyme panel can have a charge for treating each cell, plus a charge for testing each cell against the patient's plasma. Additionally if you do something to the plasma like an adsorption, you can charge for that, then charge for the testing done with the adsorbed plasma. Here are the codes: 86870 Panel 86885 Each additional panel cell 86970 Treatment of RBC for testing (enzyme, DTT, chloroquine, EGA) 86975 DTT treatment of plasma 86977 Neutralization 86978 Adsorption

I agree that a tool like this cannot be used to create a stand-alone validation process. Our thought is that some basic scripts will be developed that can be used as part of the initial validation and then later used to validate small changes.

Back to the topic of scripting tools for validation... We are looking at Boston Workstation. http://www.bostonworkstation.com/workflow_automation/product_scripting_features.aspx It is very impressive. It seems very easy to set up scripts. During the demo we thought of all kinds of uses for it besides validation. Contact them for a really great webex demo.

I completely agree that it's okay for different labs to have different sets of rules for ruling in and out. It is perfectly acceptable to use gel all the time and never even look at immediate spin. Immediate spin does nothing but get you into trouble. We are planning to drop it sometime in the near future. Those junky workups that after 10 pages of work turn out to be nothing are absolutely awful. It is definitely hard to know where to draw the line. In our lab we have lots of junky reactions in our gel screens. We used to take them to our reference lab and run a gel panel. Most junky gel screens turned into junky gel panels which propelled us into page after page of rule outs. Then finally we would go to PEG and everything would be clean. Not only were those workups a hassle to perform, but they were awful to review. Our solution was that all first time panels are done in PEG. If PEG is negative then we stop working it up. The overall quality of our patient care has improved due to increased turn around time for all workups. We have missed a few antibodies, but any method will miss antibodies. To be safe you would have to run PEG, LISS, gel, enzyme and DTT treated cell panels on every patient. And then you would still miss a few.

There are two AABB standards that allude to ruling out, but there is nothing really specific. BBTS Standard 5.13.3.1: When clinically significant antibodies are detected, additional testing shall be performed. IRL Standard 5.3.3 #1):The laboratory shall exclude commonly encountered red cell alloantibodies. AABB leaves it up to each facility to determine a specific policy for ruling out. Our facility will rule out an antibody if three antigen positive cells fail to react, at least one of those must be homozygous, except: only one homozygous cell is required to rule out M, N, Lea, Lebonly one antigen positive cell is required to rule out P1, this cell cannot have a weak expression of the antigenthree heterozygous cells are acceptable for ruling out Kwhen an Rh antibody has been identified, the other Rh antibodies can be ruled out using three heterozygous cells if needed

Our cut-off is 50 but we are considering changing it to 60. Just about anything is possible these days.

The patient probably developed the anti-Cw due to exposure to the antigen from a previous pregnancy or transfusion. If the biological father is Cw positive then the baby may be at risk. Currently it is difficult to find commercially available anti-Cw so you may need to send the biological father's sample to a reference laboratory for testing. Those of us working in reference labs would love to have a sample of this patient's serum/plasma for use in testing other patients. If you have extra sample, please consider sharing it.

The 5th edition of the AABB Immunohematology Reference Laboratory Standards is open for comment through October 18. http://www.aabb.org/Content/Programs_and_Services/Standard_Setting_Activities/propstdirl5th.htm

We do not have any requirements to rule out anti-Cw, -V, -VS, -Kpa, -Jsa, -Lua. We mostly ignore these. If we suspect that one of these antibodies might be present, then we will pursue an identification.

According to the AABB Standards for Blood Banks and Transfusion Services, "When clinically significant antibodies are detected, additional testing should be performed." Well, that is pretty vague... The AABB Standards for Immunohematology Reference Labs is a little more specific, but leaves a lot to interpretation. "The laboratory shall...Exclude commonly encountered clinically significant antibodies." Neither of these address zygosity or the need for a certain number of cells for ruling out. The rules at my facility are: D, C, c, E, e, k, Fya, Fyb, Jka, Jkb, S and s must be ruled out with three cells, one of which must be homozygous.K must be ruled out with three cells, no homozygous cell required.M and N must be ruled out with one homozygous cell.Lea and Leb must be ruled out with one cell.P1 must be ruled out with one cell, that cell cannot have a weak expression of the antigen.In the presence of an Rh antibody, the other Rh antibodies need to be ruled out with three cells, no homozygous cell required. (We do try to find a homozygous cell, but we won't thaw rare cells just to get a homozygous cell.)Sometimes we have high-frequency antibodies and we can't get the required number of cells for ruling out. In those cases we will get Medical Director approval to deviate from our SOP and go with the AABB Standard. If we simply can't rule-out we will give antigen negative cells.

From the point of view of an AABB assessor: As long as you provide access to them and you have documentation about where they are located you should be fine.

When we thaw 24-hour plasma we give it a 24 hour outdate. It is not clear if 24-hour plasma can legally be converted to "Thawed Plasma" and given a 5-day outdate.

For a patient with anti-Cw, we will perform a full XM but do not require the units to be tested for the antigen. Anti-Cw and most of the other low-frequency antiseras are no longer available as FDA-licensed reagents. If a patient has multiple antibodies and anti-Cw is one of them, it is worth the trouble to type the units for Cw. However, if anti-Cw is alone it seems a waste of a precious resource to test units.

Back to the original comment about the use of expired panel cells. Here is the AABB Standard (IRL Standards 5.1.4.2): "The criteria for the use of non-FDA-licensed reagents (including expired reagents) shall be defined." The standard does not mention a specific QC requirement, only that there must be defined criteria for use. Our lab discards panel cells 2 months after expiration. We do not perform QC on these cells.

We have a really great process for preparing, storing and thawing cells to use for allogeneic adsorption. They are listed in the commendable practices section of the aabb website. Look under section 5. http://www.aabb.org/Members_Only/Archives/Accreditation/Commendable_Practices_Educational_Resource_File/CPERFSlist.htm If you are not able to access this information on the aabb website, click on my name above, and send your email address to me. I will send the word documents to you directly.

We recently had a patient who presented with anti-Ge2. The next sample appeared to contain both anti-Ge2 and anti-Ge3. Then a few weeks later it was back to anti-Ge2 only. Has anyone ever heard of this?

Okay, so now I am making the connection. Digi-trax makes the chip that goes in the Zebra printers that print blood product labels for HCLL, right?

We are in the process of implementing Mediware.

We usually honor warm autoantibodies with anti-e or any other specificity while they are demonstrating. If they disappear or become reactive with all cells then we no longer give antigen negative. We had one patient who had auto anti-e and allo anti-E. That was a tough one. We gave her E neg for a while then her auto anti-e became hemolytic so we switched to e neg. The transfusion recommendation flip-flopped for many weeks.

We have the vendor perform a dose mapping annually. We also use a RadSure label on each product.

Has anyone started producing pheresis platelets with a 7-day outdate?

What is the CAP requirement for tubing blood?