Carrie Easley

To add confusion... Immucor audioconference 04/28 with CAP, AABB and TJC about competency, proficiency, QC and IQCP. There is a slide that states: New Reagent Lot Confirmation of Acceptability •COM.30450 New reagent lots and shipments are checked against old reagent lots or with suitable reference material before or concurrently being placed in service –Daily QC of ABO, Rh, Antibody Screen satisfy the intent of the checklist item provided acceptance criteria are defined and outcome of results are recorded –May not apply to panel cells (see TRM.31241) –Does apply to kits (such as fetal maternal screen test kits)

Is your facility able to get you a specimen from the fetus on early losses? We have a tough time even getting a cord on a late term loss!

OK, good But... just to clarify...we would never perform the rosette test without an infant Rh on record.

I'm not sure I understand the question... In order to perform a fetal screen (rosette test), you must know the infant's Rh type as it is not valid on a weak D infant. This is rarely known in an early loss. For a loss/bleeding up to 20 weeks gestation, we do an antibody screen to make certain that the mother is not previously sensitized to D, and give one full dose. After 20 weeks, we would perform a Kleihauer-Betke for a loss/bleed if the infant's type is unknown to determine if > one vial is needed.

The QC always works...that's what was frustrating. We did note on our response the mixed information that seems to be circulating from CAP regarding this topic. Hopefully they can all get on the same page, and alleviate some confusion!

We were inspected at the end of February, and got cited. I challenged stating: We are contesting this citation. We do not believe that this checklist item pertains to Blood Bank reagents verified for purity and potency by the FDA. In our facility, all screening cells, reverse typing cells, traditional typing sera, and MTS gel cards are QC’d daily with known, previously tested patient samples. All other reagents are typed each day of use with appropriate positive and negative controls. This will make evident any compromise of the reagent that took place during shipment. Since Blood Bank is not generating numbers (as in Hematology & Chemistry), but rather interpretations, the lot to lot comparison would have no added value. My challenge was not accepted, and CAP's response was: Lot to lot comparison is required for blood bank reagents. You can use your quality control if the quality control that was run on the old lot is the same lot number as what is being run on the new lot. Additionally, you have to have a policy to address this process and there needs to be documentation showing this was performed. Provide this documentation. Your challenge has been noted.