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Mary**

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Posts posted by Mary**

  1. An FDA inspector (in a military unifom) spent 3 very long days last week inspecting my Blood Bank. She was rude and disrespectful. She was a nurse and did not have much working knowledge of the field.

    Some of the things she "sited "were anything "handwritten" even if it was initialed and dated, lack of a procedure on how to take the daily temperatures even though the ranges were on the log sheet, a freezer alarm high set point was -20 C and the freezer alarmed at -19.9 and I could go on and on. She wanted copies of everything she didin't like. She even wanted copies of entire maufacturers equipment manuals.

    The only reason we get inspected by the FDA is that our radiation oncology departemnt irradiates about 12 units a year for us. She spent about 20 minutes in oncology (out of 3 days) and did not site a single "Crossout", etc. I plan to have our Blood Center do our irradiation in the future and therefore to avoid this abuse.

    I have never had a single CAP citation. Everything she tediously looked at and lectured me about repeatedly.

    Large hospitals in my area and our Blood Center have also experienced the same issues recently, but we all had different inspectors. This was some consolation to me. Are they trained to act in such an unprofessional manner or what?

    I guess I am done venting!!!:bonk::bonk::bonk:

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