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Showing results for tags 'fda'.
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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.
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- fda
- aabb standards
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