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3rd Jan 2019, 01:38 PM
#4
Hi Matt and Rashmi
Thanks for the considered points Rashmi and I agree a change control would help to ensure the correct decision is made according to good practice.
It is not for MHRA to consider the rights or wrongs in clinical decisions like this, but my only comment would be that in my experience, a 72 hour limit would not be outside of the norm. When assessing SABRE reports I assess them as errors against the local QMS, not the BSH guidelines. I have seen a variety of sample validity timings including 72 hours for all, and even 48 hrs across the board to ensure that issued blood is identified and removed from the supply chain in good time. I couldn't tell you how many labs do what, just that I have seen it through SABRE reports.
Does anyone else who practices 48 hr or 72 hour validity have any comments?
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