I am new to validate blood bank automated instrument. I have a question regarding the daily reagent QC on Galileo Echo. The package insert of WBcor QC lists the expected results of each vial. However, there is no reactin strength mentioned and refer user to use the operator's guide. I look thru all pages without any success. Is there a CAP requirement to have reaction strength established for the daily BB reagent QC? Does it apply to tube method only? How do you establish the reation strength if needed? Can anyone share your thought and experiences? Thanks in advance.

Cathy

I am not aware of any "strength of reaction" requirements by CAP.

You may establish such "minimal acceptable strengths" for your own facility, if you want to. Since to do so would be "above and beyond" the requirements of the accrediting agencies, it would be totally up to you to decided how to establish the required reaction strength.

I am new to validate blood bank automated instrument. I have a question regarding the daily reagent QC on Galileo Echo. The package insert of WBcor QC lists the expected results of each vial. However, there is no reactin strength mentioned and refer user to use the operator's guide. I look thru all pages without any success. Is there a CAP requirement to have reaction strength established for the daily BB reagent QC? Does it apply to tube method only? How do you establish the reation strength if needed? Can anyone share your thought and experiences? Thanks in advance.

Cathy

Hello Cathy,

I've heard of hospitals using a dilution of their anti-sera as part of their qc protocol. The rationale is to test the ability of the instrument to detect low levels of antibodies. I would think this discussion could be had with Immucor as the practice is not unknown in the UK. Having said that, this practice would pretty much come under the "above and beyond" clause.

Tony

Hi Cathy,

I think the daily WBcorQC for the ECHO is similar to the test run on the Galileo, and that doesn't have a strength of reaction to be graded. I personally find this test fairly meaningless. Ask yourself what is actually being tested by running this control? It would be safer to run 'bog standard' A, B, O controls that give you clear blood group interpretations that everyone understands.

However, as this is a recognised control for the analysers, and failure of this would, I presume, prevent the equipment from working (??) until an accepted test is passed you would need to continue using it (unless you risk assessed this).

We currently use whole blood ABO Albacheck controls as recommended by Immucor (UK). Also run our own weak antibody controls (anti-Fya, -S) in addition, even though Immucor say this isn't necessary as each 3 cell screen has a pre-bound control on the end ( saying that I have NEVER seen this pre-bound control fail).

Question all the controls that you will running (or not) on this equipment until you understand and are happy with exactly what reagent and part of the test is actually being controlled.