Everything posted by Cliff
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We report about 75 a year. FDA rejects 2 or 3 a year. -
Yes, they are amazingly receptive and helpful I've had many emails and several phone calls with them. Always helpful. (240) 402-9160 bp_deviations@fda.hhs.gov hctp_deviations@fda.hhs.gov
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Hmm, not sure. We have not been able to solve our "failure to issue in the computer" dilemma, but one thing we added was capturing all of the computer steps on a paper that is saved in the blood bank. We save a paper that has a sticker from the unit, we date / time stamp it and initial it. Our SOP says that the initials indicate that all of the safety / suitability checks have been done on the unit. We still investigate these events and try to resolve them, but those are not reported to the FDA. Nothing went wrong except for some record keeping.
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We'd be very happy to have you help with submitting questions to be used for Question of the Day. Please submit them to this form: https://goo.gl/forms/2yOF8TlSG6QmZugC3 Thank you
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Docket Number: FDA-2017-D-5152 Issued by: Center for Biologics Evaluation and Research We, FDA, are issuing this guidance to provide you, establishments that collect Whole Blood or blood components intended for transfusion or for further manufacture, including Source Plasma and Source Leukocytes, with recommendations for a requalification method under Title 21 of the Code of Federal Regulations (CFR) 630.35(b) (21 CFR 630.35(b)) for donors who had been indefinitely deferred for a history of viral hepatitis after the 11th birthday, prior to the elimination of the donor suitability requirement under 21 CFR 640.3(c)(1) and 21 CFR 640.63(c)(11). -
We use regular Igloo for most of our coolers, we're switching to Credo coolers. We have 20 of the Credo so far, about 40 or so of the regular ones. The Credo will hold 1-6 for about 14 hours, we tell people outside the blood bank 12 hours.
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Yeah, I suppose I am dating myself a little. I memorized Standards and most of the FDA regs when I was studying for my SBB.
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The job description is wrong, JCAHO is not TJC. Will you be responsible for managing inspections / assessments on your own? For me, it's been a long journey over the past 20 or so years, mostly self learning. Before I took my current position, I had memorized the AABB Standards, knew the FDA regulations very well, was familiar with TJC (then JCAHO), knew nothing of CAP nor OSHA.
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Yup, she has contacted me and we're working with her IT department.
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Thank you kindly. And for those that are not fortunate enough to have received written correspondence from Malcolm, his handwriting is impeccable. The files are now in the Library:
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Thanks, I did read this but did not take it as a strict rule that it must be infused within 4 hours after leaving it's controlled environment. I need something more substantial than "undesirable". Regardless, I may make the suggestion we change to 4 hours from the time it leaves it's controlled environment.
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I think we can all agree that products must be transfused within 4 hours. I cannot find when this 4 hour window starts. Does it start from the time the transfusion starts? What if it took 45 minutes from the time it left a controlled environment to the time it started? Do I only have 3:15 left? Do you have a policy on when the 4 hour time starts? I'd like to propose it's from the time it leaves the controlled environment. This would be a huge change for an organization as large as us, I want to make sure I'm not missing something. Thanks
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Hmm, I got neither. I am having email issues. If you sent it to my Verizon email, please PM me and I'll give you my gmail address. Verizon is working sporadically, I suspect they don't care as they are going out of the email business.
June 17 I will run up it again, then I am doing the ride up it in August.
Another vote for validate. We had a call with two people from FDA. Our IT wanted to do a build on server A, all of the testing and validation on server A, then at go live, exactly replicate server A on server B and have server B be the new production server. Our IT said since it would be identical it would not need validation. I disagreed (as I often do), hence the call with FDA. FDA agreed that server B was not validated and not suitable for use prior to testing and validation. When I approach these events I try and understand what I want to accomplish. Am I just meeting a regulation and there is no safety to the patient / donor added? Then I do the least required. Is there a chance, even a small one, that data could get compromised? Then I do a full validation, regardless of what's required.
I suspect your answers will vary wildly. We are a level 1 and we also support a huge OR and very busy cancer center. We are a donor center, we are about 15 miles from our supplier. Our minimum inventory for platelets is 30.
Sorry, I read this with my blood bank hat on, I would not want sattelite blood bank labs.
We're a fairly big facility with a level 1 trauma center, 40ish ORs and a large cancer center we support. We do not have any satellite labs, nor are we even considering it. Why do you feel this would be better? Is the ER part of your facility?
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