Dansket

Are you inspected by the AABB?

An important aspect of this conundrum to remember is that physicians do not treat newborns just because of a positive DAT, they treat infants who are anemic or hyperbilirubinemic regardless of the DAT results.

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Over the decades since Rh Immune Globulin became available and a standard for care in 1968, the guiding principle changed from 'looking for reasons not to give', i.e. withholding the injection versus currently 'looking for reasons to give'. Initially, the injection vial was packaged with a crossmatch vial that required a test tube crossmatch with the patient's rbcs. This was a safety step to address the concern of giving such a large volume (at that time I think it was 5ml in the US) of anti-D to an Rh positive individual. Much later, it was determined that a second injection was required around 28 wks to prevent sensitization of women who might be hyper-responders. Those safety concerns have been addressed with low volume (0.7ml), low protein formulations. Crossmatching is no longer required. Performing an antibody screen with a workup is consistent with the original philosophy of 'looking for reasons to withhold the injection'.

We trained Nursing that the Typenex band was the only means of identifying a transfusion recipient. That statement was preprinted on the compatibility tag attached to the blood container and had to be signed by two Nursing personnel. Nursing was instructed that If a mismatch between letter-number code on Typenex band and the Typenex label on the compatibility tag was detected, do not transfuse regardless of any other band on the patient.

You might consider offering an alternative to the Typenex bands that would satisfy both sides by offering an electronic system that mimics the rationale for the Typenex system. The current Typenex system is based the use of bar coded blood sample container labels that can only be sourced from the patient identification band. An electronic mimic of Typenex can be used for identification and labeling of all laboratory specimen containers.

We elected to use the same form as used for blood transfusion. It is preprinted with some RhIg specific text. Our Meditech system is configured to print the RhIg syringe expiration date.

At the beginning of the testing process, ProVue warns the user with a disclaimer displayed onscreen that hemolysis, icterus and turbidity (wbcs, lipemia) may interfere with reading of a sample. ProVue takes an image of the gel well and does a gray-scale analysis. The presence of turbidity, hemolysis and icterus would darken the image and prevent analysis due to lack of contrast. Byfaith was asking if her current criteria is too restrictive and for options for sample rejection criteria when using automated gel testing. My suggestion was to let the machine determine sample acceptability. Using a visual color chart comparision process that was probably developed for manual tube testing ignores the machine's capability to do sample rejection that is more consistent and appropriate for the machine.

We use Alba-Q-Chek. Packages are stored upright. On the day we open a new set (set expires 7 days after opening), we mix vial 4 thoroughly by inversion and then add 40uL of Ortho Anti-D BioClone, thoroughly mix by inversion again and centrifuge. This gives us a positive DAT control (reacts 1+ - 2+ consistently for 7 days) to run on ProVue. Any of the other 3 vials can be used as a negative DAT control.

I don't reject samples based on visual inspection, I let ProVue decide. If ProVue can't read the gel card and if the user can't read the card manually, then we reject the sample and get a new sample.

I think you need to demonstrate in Day of Use/Daily QC that the Anti-IgG Gel card reacts properly with positive and negative control, not only in the Indirect Antiglobulin Test (indirect agglutination with 37C incubation), but also in the Direct Antiglobulin Test (direct agglutination without incubation).

I'll assume you are doing Gel testing manually. I think you are wise to convert routine ABO/Rh and Antibody screen from tube testing to Gel testing. To QC the antibody screen test using Surgiscreen and Anti-IgG Gel card, you need a positive and negative control cell for each screen cell vial. This can be accomplished in one (1) Anti-IgG Gel card. To QC the A/B/D Monoclonal and Reverse Grouping card, you will need to test each reagent in the gel card with positive an negative controls (this will require a minimum of two cards). You can QC the two (2) Buffered Gel columns with anti-A + A1 cells, anti-A + B cells, anti-B + A1 cells, and anti-B + B cells using the same two A/B/D Monoclonal and Reverse Grouping cards. You could use the A/B/D Gel card to confirm all donor unit types or you could use the A/B Gel card for non-group O Rh positive units, the Anti-A,B Gel card for all group O Rh positive units, and use the A/B/D Gel card for all units labeled Rh Negative. All these cards would require Day of Use QC. You could use the A/B/D Monoclonal and Reverse Grouping Gel card or the A/B/D Monoclonal Grouping card for Cord Blood testing. These cards will not detect all weak D's. You will have to run Weak D testing on all Cord Bloods initially classified as Rh Negative. There are other options based on your workload.

Does your investigation-of-an-adverse-reaction-to-blood-transfusion-protocol for non-cellular blood components require testing the pretransfusion blood sample? I think this standard could stand an infusion of clarity. I read it as 'Patient samples for all transfusions and a segment from any red-cell-containing component shall be stored at refrigerated temperatures for at least 7 days after transfusion.' Maybe someone can get clarification from the AABB as to their intent for 5.11.4.

30th edition of the AABB Standard 5.11.4 states, "Patient samples and a segment from any red-cell-containing component(s) shall be stored at refrigerated temperatures for at least 7 days after transfusion." Bold-face type is my emphasis.