A little lab lost

We were inspected recently and did not have any UoM for Diamed systems, which they had no issue with. We do however have a table in the SOP listing mitergation of uncertainty for the analysers but no actual calculations and they were happy that we had considered it. I think in the standards it says to 'consider' uncertainty so we listed things like IQC, EQA, competency assesment of users, 3rd party controls, standard reagents that have a BAT etc.

How do people report patients with prophylactic anti-D? We report them as antibody screen negative but a comment stating the remains of prophylaxis detected. I'm not convinced we should be saying it's neg if Anti-D ig is present. I'd be interested to see what others do and if I'm getting my knickers in a twist over nothing!

Did she have anymore anti-D Ig after the sensitising event? I would have thought the increase in quant would be due to that, or she could have started making immune anti-D if she wasn't given any/enough following the bleed. I've moved from a reference lab to a hospital and I've never been keen on looking at the strength of reaction to basically have a guess if it is prophylaxis. The clearance or lack of clearance of Anti-D Ig is down to the individuals immune system.

Thanks Malcolm, I'll do some more digging.

Can anyone help me with this. I'm relatively new in post at a new trust and I'm trying to pull together some documentation for Good Laboratory Practice. Over the past couple of months I've found myself pulling up staff on basic stuff like labelling tubes, writing down lot number etc. The most common comeback are 'well it's not in the SOP' or 'It didn't matter before when X was here'..... Are there any standards for GLP out there or is it something just drummed into you?? I don't remember it being part of my training as such, just how you do things. So my plan of action is a formal GLP document and to incorporate this into our next round of competencies. Any advise would be gratefully received.

I'm fairly sure the ISO std talks about controls covering all biological intervals. I haven't got them to hand so cannot find the quote. We have not been inspected yet but use the Biorad QC too. I there is an Alba QC kit which would cover everything that I'm thinking of trying. Just need to write the validation, change the SOP's.......

Thanks, I think that has convinced me to order some. I was hoping to get away with the NBS weak anti-D as it's pre made and we are about to start using it as the panel control. Now I've just got to write the validation document!

I am considering using a NIBSC anti-D for a comparison study between the automation and manual testing. I'm unsure how often this should be done to comply with ISO 15189.