hello all

are there any written regulations for QC on blood group analyser ? I try to find something in the AABB Standards but I didn`t find anything - I need some help

thanks

Hi Cornelia,

Forget about any regulations, and go back to doing what would be the correct thing regarding controls. Each of your antisera and reagent cells must be able to demonstrate positive and negative reactivity. Together they must be able to allow you to interpret the result to a conclusive blood group.

With antibody screens, you need to use weak controls that demonstrate that any fragile antigens can be detected (anti-Fya) throughout the shelf life of your reagent. Additionally, each of these screening cells should be tested to show pos/ neg reactions.

If your equipment uses a wash phase, you should be able to prove the efficacy of this procedure- by demonstrating there is no residual plasma proteins that could cause false negative reactions- during each wash cycle.

We all need to 'go back to basics' with handling of controls. Simplify and do the most logical thing- then you can't go wrong.

Hi Cornelia,

Forget about any regulations, and go back to doing what would be the correct thing regarding controls. Each of your antisera and reagent cells must be able to demonstrate positive and negative reactivity. Together they must be able to allow you to interpret the result to a conclusive blood group.

With antibody screens, you need to use weak controls that demonstrate that any fragile antigens can be detected (anti-Fya) throughout the shelf life of your reagent. Additionally, each of these screening cells should be tested to show pos/ neg reactions.

If your equipment uses a wash phase, you should be able to prove the efficacy of this procedure- by demonstrating there is no residual plasma proteins that could cause false negative reactions- during each wash cycle.

We all need to 'go back to basics' with handling of controls. Simplify and do the most logical thing- then you can't go wrong.

Rashmi

I absolutely agree with you back to basics are the best. And if we do not have any FDA regulation your answer will fit perfect- thank you for that comment .

The guidelines are the same as for tube testing. Each reagent must be tested on each day of use according to the manufacturers recommendations or meeting CAP/AABB standards. As for instrument specific QC, follow the manufacturers recommendations like you would any other piece of equipment.

The guidelines are the same as for tube testing. Each reagent must be tested on each day of use according to the manufacturers recommendations or meeting CAP/AABB standards. As for instrument specific QC, follow the manufacturers recommendations like you would any other piece of equipment.

thank you very much for your reply

Cornelia

The manufacture's instructions provide the minimum required and even for those of us in the US it is sufficient for the FDA. The bottom line as previously stated: a positive and negative for each test. A cell can be the control for more than one test, e.g. group O cell for anti-A, Anti-B and -A,B (if you're using it) and negative for antibody screening if that is what the instrument is doing and the phenotype is correct.

Frequency is more the issue. It is also generally specified in the manufacturer's instructions. Does your machine stop working if QC not performed... you can back into it that way, although it's a bit of a waste of time. Daily... or each shift which then becomes [potentially] more expensive but makes your techs take responsibility.