Mary**
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Posts posted by Mary**
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Thank you for your support.
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Thanks David. I don't think this inspector could have calculated anything. She did a percentage on a calculator incorrectly. She wanted to calculate +/- 5%, but added 5! I helped her.
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I needed that! Thanks.
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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:
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:cries:If the FDA goes through with it, those of us who use Immucor products, especially red cell products could end up without any reagents!
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;)Helmer is the way to go! The thawer and the company are great!
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I am glad you enjoyed it.
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I glad I don't work for a State run hospital.
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Thanks. I found them in the AABB Technical Manual.
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Does anyone have current statistics for the rate of transmission of infectious diseases (HIV, Hepatitis, etc) from a blood transfusion? References would be nice to have also. Thanks.
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Maybe Fenwal.
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This appeared in our blood center's newsletter.
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The use of historical types is not permitted.
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:DI agree with you. You can inspect us anytime!
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Yes, the rosette test isused for the routine screening of post-partum mothers.
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What would happen if a new nurse was transfusion???
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Yes, I had a voice mail regarding that yesterday.
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I am glad it got to you.
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Keep us posted, as I hope Helmer would also do.
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Interesting.
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It is on it's way!
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Well, that didn't work either! How about the mail?
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I totally with TrekTech2. It is a great cell washer. We flush it weekly.
FDA Inspector
in Accrediting Agencies
Posted
Thanks for the link.