Dansket

US accrediting agencies require that transfusion services perform serological testing on a donor tubing segment from Red Blood Cells to confirm ABO/RH. Is this also a requirement in the UK?

Antibody Screen and Antibody Identification are linked but separate processes with different purposes. A negative antibody screen with a minimum of 2 cells has been established by blood bank regulators as a decision point regarding the requirement to perform an antiglobulin crossmatch prior to transfusion. An antibody screen is intended to detect unexpected antibody, not to identify it. Identification requires different criteria. Therefore, an antibody screen is an acceptable method to 'rule-out' the presence of unexpected antibody in patient blood sample.

You are correct, it was John Judd's recommendation at the University of Michigan.

Thanks, goodchild, I'd taken this CAP requirement for granted as I have been using computer systems that automatically met this requirement over past 20+ years. As a result, I have never been cited for not doing this check or for not reporting ABO/Rh testing with a disclaimer when there was no historical record on a pregnant patient. I interpret CAP's note to TRM.40820 as requiring a disclaimer only if a historical records check was not done. I would need to see much stronger or more explicit language from CAP to compel me to routinely report a disclaimer when there was no historical record on a pregnant patient in the preceding 12 months.

Yes you do have to order it and it is not free.

We also put a computer flag to indicate a second ABO has been done in-house. We require this even for patients who do not qualify for electronic crossmatch. Blood cannot be issued through the computer unless the patient is flagged accordingly. However, this is not part of any patient report. It would be interesting to know if large reference labs like LabCorp or Quest routinely incorporate such a waiver on every non-transfusion ABO/Rh determination they report, regardless of who collected the blood sample.

We use ORTHO's Alba Q-Check Simulated Whole Blood Controls. This set of 4 QC vials is designed for the Gel method, both manual and automated. However, all the antibodies (anti-A, anti-B, anti-D, anti-c) in this QC system react strongly (3+ to 4+).

Another approach is to retrospectively review the strength of agglutination observed in patients with a positive antibody screen over a period of time. I can tell you that 70-80% of all my positive antibody screens are weakly reactive (1+ to 2+) despite daily QC that reacts strongly (3+ to 4+).

Have never done this. Not aware of any such requirement by regulatory agencies. Can you reveal the circumstances that lead to this discussion?

Have you contacted the vendor? What is their response to this testing failure?

ORTHO will probably give some insight and direction for you. Has your lab selected a key person to send for training?

amym1586, How often do these emergencies occur? Why do they treat every blood sample as if it is a potential emergency? When did the last emergency occur and how many units of ABO identical blood were given based only on a forward typing. How many minutes do they centrifuge these blood samples? Dansket

Column agglutination technology (Gel) does a superior job of detecting mixed populations of red cells in a blood sample compared to standard tube technology. Having done ABO/Rh typing on ProVue since 2004, I've seen dozens of samples with dual population due to transfusion of a single unit of RBC that was not ABO/Rh identical to the recipient. I think these mixed-field reactions (typically be missed in tube) are clearly visible in Gel. Using an unspun sample of blood to do a forward ABO grouping isn't wrong, but is it really necessary to do this routinely on all blood samples? Does the SOP give any explanation for this approach?

Whether or not, a second blood sample is required is driven solely by the actions of the CLS doing the initial ABO/Rh determination on a current blood sample. It is not a Nursing decision, not an MD decision and not a phlebotomist decision. We do not accept unsolicited blood samples collected by anyone, including anesthesiologists in Surgery, other medical personnel in ER or Trauma, to be used for ABO confirmatory testing. If there is no "ABO,Rh" on file in the computer system, the current uncentrifuged blood sample is tested with anti-A,B (tube test). Results of the anti-A,B test are entered in Meditech 5.66 and filed. If anti-A,B test was positive, Meditech automatically reflexes an ABO confirmatory test using a new specimen number and prints specimen collection labels on the Phlebotomy label printer. We use the TYPENEX Blood-Recipient Identification system and require that labeling of the confirmatory blood sample include the TYPENEX number/letter code (only available at patient bedside). This code must be entered in Meditech with the confirmatory test results. Meditech is configured so that confirmatory results cannot be filed/verified if the TYPENEX code does not match the TYPENEX code previously entered on the current blood sample. ABO/Rh determination and ABO confirmatory testing are done on ProVue and results entered in Meditech. Meditech is configured so that ABO determination cannot be calculated if the anti-A,B test result does not agree with ABO determination test results. Meditech is also configured so that blood components cannot be issued if the ABO confirmatory test on the second blood sample has not been done or does not agree with the ABO determination done on the first blood sample. Collection of the second blood sample is rigorously controlled to insure that a venipuncture is done after a second visit to the patient's bedside.

According to our SOP, patient whose current antibody screen is negative and a history of clinically insignificant antibody qualifes for electronic crossmatch.

BBfuntimes, Is you IS crossmatch done in standard tube or in Buffered Gel?

To clarify, the Anti-IgG Gel card may not be used to detect ABO incompatibility by the indirect antiglobulin test. However, the Buffered Gel card may be used to detect ABO incompatibility by the direct immediate-spin test.

If there is evidence for hyperbilirubinemia and/or anemia, then test newborn for serological evidence of hemolytic disease of the newborn. I don't see the purpose of performing ABO, RH, DAT, etc. on newborns without either symptom. These tests do no reliably predict which infants will require treatment. I did a study that focused on 26 infants given phototherapy during a period of 1300+ deliveries. 50% of the treated infants had a negative DAT. Physicians treat the bilirubin level, regardless of the DAT result. Would any MD initiate phototherapy on an infant with a positive DAT, but a normal bilirubin? Would any physician withhold phototherapy from an infant with hyperbilirubinemia and a negative DAT?

We run positive/negative controls for both Antibody Screen and IgG DAT on ProVue. The results demonstrate that the Anti-IgG gel card detects coated rbcs by both direct and indirect antiglobulin testing methods.

We do not issue multiple RBC units for non-emergency transfusion unless the units can be infused simultaneously, i.e., more than one existing IV line.

If you have a specific form that requires a physician's signature prior to transfusion of "crossmatch-incompatible" or "least-incompatible" red cells, would you post it please. I have to develop such a form and appreciate any assistance. Thanks

The most important question and requirement is, "Does it have FDA approved Computer Crossmatch?". Secondly, as BBK supervisor, you must have administrative access to the configuration tables and parameters. If it is controlled by IT, don't bother. you won't like any vendor. BBK supervisors have a vested interest in being able to configure the software to their needs. To IT, it is just another application they have to manage, in addition to all the others currently on their plate.

Being able to respond to an inspector's inquiry for evidence that patients identified as candidates for Rh Immune Globulin and verify the injection is essential to the process, whomever dispensed it whether Blood Bank or Pharmacy. If your process can accomplish this, it shouldn't matter which department dispensed it.

See attached. This is essentially a large label with some portions intended to routinely be removed.2nd ZK8367 rev.pdf2nd ZK8367 rev.pdf

Over the years, tube testing antibody screen has changed significantly: eliminating room temperature incubation (just immediate-spin), then doing away with immediate-spin, eliminating the saline tube and doing 37C Albumin, switching from Antihuman Globulin to Anti-IgG antiserum, then dropping albumin in favor or LISS, reducing incubation time from 30 minutes in albumin to 15 minutes in LISS. So when I hear about tube testing being the "Gold Standard", I ask, "Which flavor of antibody screen is it?". 4-tubes, 2-tubes, two-cell screen, 3-cell screen, 4-cell screen, immediate-spin and room temperature/both or neither, Saline and Albumin, Saline only, Albumin only, 37C-to-Antiglobulin only, LISS-suspended cells, LISS-additive, PEG? How many varieties did I miss? Tube Testing was a journey, not a Gold Standard.