RR1 Posted January 26, 2014 Share Posted January 26, 2014 Please can you tell me how haemovigilance reporting works in your organisation : What is the process and who is involved in deciding if an event is an SAE- and reportable to MHRA ? Thanks Link to comment Share on other sites More sharing options...
Auntie-D Posted January 27, 2014 Share Posted January 27, 2014 We have it that the lab staff incident log any error and report it to the lab manager/SPoT who then decide if it is reportable. Seems the MHRA aren't too fussy any more about cold chain and don't want to know about blood out of hand fridge for less than 5 hours - we got a lot rejected... Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted January 27, 2014 Share Posted January 27, 2014 Wouldn't bet on that for long Auntie-D. They have a habit of leaving something for a while (because it is getting generally better) and then coming back to it, and woe betide you if you have slipped. Critical, or at the very least, Major. Link to comment Share on other sites More sharing options...
RR1 Posted January 27, 2014 Author Share Posted January 27, 2014 They are however looking at time expired blood being available in the issue areas and units not re-stocked in time after these have passed reservation suitability date. If the cold chain failure means that unsuitable blood is available for transfusion (ie taken out of fridge > 30mins and then returned to fridge instead of handing to lab staff, then I thought they were interested in these- because it shows a failure in proper control? If blood is out of fridge for >30mins, but is transfused to the intended patient within 4hrs (timing we use), then this is ok. Thanks Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted January 27, 2014 Share Posted January 27, 2014 They'll STILL get you Rashmi!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Not that I'm biased against them, of course. Link to comment Share on other sites More sharing options...
RR1 Posted January 27, 2014 Author Share Posted January 27, 2014 They'll STILL get you Rashmi!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!Not that I'm biased against them, of course.They are not out to get anyone Malcolm...... you know my thoughts on this!!! And, I've heard that your particular inspector is actually very nice.!!!! Malcolm Needs 1 Link to comment Share on other sites More sharing options...
Auntie-D Posted January 28, 2014 Share Posted January 28, 2014 Wouldn't bet on that for long Auntie-D. They have a habit of leaving something for a while (because it is getting generally better) and then coming back to it, and woe betide you if you have slipped. Critical, or at the very least, Major.We still report them all - we care It is probably like Rashmi says - the blood isn't blood that has been returned to stock to use on another patient - it's just a delay in the commencement of the transfusion... Malcolm Needs 1 Link to comment Share on other sites More sharing options...
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