Posted January 26, 201411 yr comment_54349 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
January 27, 201411 yr comment_54360 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...
January 27, 201411 yr comment_54362 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.
January 27, 201411 yr Author comment_54363 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
January 27, 201411 yr comment_54365 They'll STILL get you Rashmi!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Not that I'm biased against them, of course.
January 27, 201411 yr Author comment_54368 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.!!!!
January 28, 201411 yr comment_54375 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...
Create an account or sign in to comment