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Showing results for tags 'fda'.
Found 4 results
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So, my manager (I'm the asst. mgr) has me looking at ALL our reagent IFU's to make sure that our SOP's are in line with the IFU's since this new FDA thing is coming up stating that anything used outside of the IFU is an LDT.....(or something to that effect). We are a large academic medical center and do 95+% of our own abid's. As I'm reading these IFU's for screen and panel cells they are all saying "Do not use beyond expiration". We often use expired panel cells to help R/in or R/out antibodies - does this new ruling mean that we can no longer do that....? Even if we run +/- controls? I'm stressing just a little! We also freeze some of the more "rare" antiseras - but we don't "report" those reactions or interpretations............so, basically that's just for "information"
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Has anyone out there done this records request inspection from the FDA? Curious how you provided the information and what your experience was if you are willing to share.
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I was wondering if anyone knew of a report that showed incident rate of FDA reportable events per hospital or per other statistic like transfusions, patients, etc... Just looking for a baseline to see how our facility compares to others. I have searched and reached out to other facilities and haven't had any luck. Thanks in advance.
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Do the Blood Bank refrigerator and freezer have to be externally monitored outside of the blood bank? The lab is staffed 24/7 and able to respond to the freezer or refrigerator alarm. Does security or the Emergency Department have to also externally monitor these alarms? Are there any CAP or AABB standards, or does the FDA require this? Just wondering since it seems to be redundant, and we have an older freezer which may be difficult to hook up.
