One of our sister sites was recently cited by HFAP for not following their Anti-D package insert (BioRad Seraclone Anti-D blend for tube testing). Their procedure is to interpret any obstetrical RH type that reacts 1+ or less at immediate spin NEGATIVE until they refer the sample for genotyping. A chartable comment is added to the result stating that the reaction was discordant and that the sample was referred for genotyping. If genotyping shows a Partial D, the interpretation stays as Negative. If the genotyping comes back as weak D 1, 2, 3, or D+ the interpretation is corrected to Positive and a corrected report sent. However, the BioRad package insert says "agglutination of red cells is a positive result". hence the citation. We realized that the "less than 2+" rule in the procedure refers to the FORMER Anti-D reagent (Immucor Series 4) and the SOP was left that way when they switched to BioRad. They aren't interested in changing the current process, because it has helped identify at least 3 partial D mothers who would not have received RhIG if the insert had been followed to a T. My question is, does anyone else follow a similar "less than 2+" rule, have you been cited, and what Anti-D reagent are you using? Do you result these patients at "Indeterminate", at least until genotyping is complete?
Thank you!
TRabs10 reacted to gene20354 in GEL DAT CONTROLWe run the monoclonal control card in parallel with the poly card to catch the false positives.
