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Everything posted by RR1
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Hello Shily, I think you already have many friends on BBT. I enjoy reading your posts.
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Hi Liz and Bankergirl, Multidisciplinary policy sounds much friendlier than technical agreements- I think I'll use that term from now on- might find a bit more cooperation with getting them signed-off. Thanks.
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Hey Cliff, May be we could have Karma points and power levels as well as thanks buttons etc ...like some other sites????- could make it exciting, though I'm not quite sure the significance of them. Anyway, I am still convinced it was all Malcolm's fault the thanks button self destructed!!
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Thanks aakupaku, we have those too- but we are required to develop close links with other departments within the hospital especially if they perform tasks/ have shared Blood bank responsibilities e.g maintenance of the LIMS or even the shared hospital drives, if these contain important data. The risk department is another one that we have specific arrangements with too. (p.s for the record- I wish I had been on a long vacation!!!...but just needed to spend time away from the computer at home, amongst other things!!)
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Welcome to BBT Generic!
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Larry was a valuable member of this forum Rebecca, and he will be greatly missed.
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Thanks lalamb and BSIPHERD for sharing your checklists- they all seem to open with no problem. I have attached some of the basic ones we use or trying to use!!). general tasks.doc senior checklist.doc task list grouping.doc
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We use iLaboratory (Apex), I was told by our Path IT folk that this was purely a change from the current server which was deteriorating to a new box....would this necessarily mean the operating system would change too?- sorry I'm hopeless with computer stuff !
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We are due to replace our computer server and I need to write a validation plan etc. What would be the main things I would need to consider, I have the following: 1. Check no corruption to traceability data and historical records 2. Check interfaces/ printing etc 3. Check compatibility rules 4. check special interest/warning flags are ok 5. Check stock entry/returns 6. Check input of results 7.Check password access levels for various activities/restrictions. What other things would I need to considr, not only from the blood bank point of view- but Pathology/IT aspects too? Many thanks!
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I am just trying to find out how folks really feel about using checklists in the lab for all key functions, e.g Routine grouping areas, crossmatching bench, 'other miscellaneous' tasks. We have recently introduced new ones to cover things which tended to get overlooked but are actually very important to a well functioning lab, but these are seen to be onerous to staff trying to use them. What sort of tasks do you add to your checklists- and how do you assign responsibilities to completing these? I am especially interested in following:daily review of incidents, recall/ quarantine events, inputting referred sample reports, checking antibody panels, checking QC logs/ equipment maintenance logs etc...what some people would call peripheral lab tasks. thanks!
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Thank you Cliff, I think it's a fantastic change. I am sure this will increase learning opportunities for everyone and possibly help develop more respect between Pathology disciplines.
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Just wondering to what extent folks are drafting agreements or shared SOPs with other departments within the hospital. I am particularly finding it difficult to convince senior manager that there also be one with the hospital IT department to clarify arrangements, - but this is probably a losing battle. Any ideas?? Thanks!
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Thanks Gregor, I was wondering when these were coming out-at last, some more fun bedtime reading!!
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Something else to think about is that if you can't resolve the problem how do you address all testing that was performed PRIOR to the failed QC and up to the last good QC? The QC tests all reagents used for the test itself and the operators performing the test; if one of your staff submitted an incorrect results on an external QC (NEQAS, or CLIA) ,would you not also want to check their performance and also audit some of their previous work to see if any patient results had been compromised too?
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New MHRA document attached detailing requirements for labs performing electronic Issue. Some very good points in this and definitely a bit of work involved. It seems implementation PLANS are required by 31st July 2010 with risk assessments on current processes used. Nice to see there "should be evidence of senior management support (at Trust/ Board level) for any resource requirements to implement the plan". Would be good to discuss. thanks MHRA Guidance on Electronic Issue.pdf
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Hi adiescast, in the UK section: Quality area, Irene59 has asked the same question and I have attached the SOP that we use for Out-of-spec testing. OOS testing is not just about serology tests- but any (validation, computer checks etc) where the main point is that an unexpected result is checked to explain why this happened and if you can't explain the anomaly the repeat must be performed fairly and show the "correct" result is consistently repeatable. The MHRA cited us for "testing into compliance" during one of our inspections, where we had recorded a failed QC that was re-run and passed first time. On the internet the policy for OOS testing seems to be a fairly hot topic with the FDA too.
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Thanks Eoin, that's what I thought and have declared on the current compliance reports. I get the feeling that there are labs not performing routine inventory checks and assigning missing units as traceability failures, and some personnel even consider traceability as purely the confirmation of transfusion. We should obviously not be missing units but this could happen if staff don't fate damaged FFP or cancelled requests properly;or there may be limitations with computer systems. I have even heard that some sites have set their stock to auto- fate as 'time expired' in stock fridges/freezers- and don't consider this as 'auto-fating' for traceability purposes,which it is! We all need to get these basics sorted, the worst thing is that the more you dig, the more you find to correct.....aaargh!!!
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Thanks Tony....I can feel a bit of lobbying coming on now, where do we start??!!
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Hi Tony, I think I mean that as SHOT is collecting such valuable information, would it not be easier to make SHOT the primary (and only!) organisation for reporting everything to. The data that MHRA require could then be included within the same questionnaire and easily extracted- and there would be a formal agreement between SHOT and MHRA for this arrangement.
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Sorry to bring this horrible but important topic up, but I just need to know how others are approaching this: When you workout your monthly traceability %, do you include units "lost" / unaccounted for when your stock inventory is checked- as part of failure to trace the units? many thanks!
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Hi Steve, If you validate the NHSBT screening cells once a year ( by getting in a couple of one-off sets), in the event your supplier fails to deliver you just order what you can from the NBS (though I'm not sure they would be able to cope with the extra demand) and just convert over at the time of crisis. If you're really bored you could try validating from two different supplier!!! The main thing is to keep your validation up to date, but this does not mean you have to regularly purchase these.
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The main points with response so far is that you are not meeting regulatory requirements for handling out of specification results (QC failures). If you simply re-run the control when you are unsure of what the reason for failure was this is known as "testing into compliance" which is not allowed.
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Am I the only person in the UK who would really like MHRA and SHOT to streamline their haemovigilance reporting systems? Why can't there be ONE system in place- this is very un-lean and becoming even more time-consuming. Additionally we have to remember another set of passwords!!!!!
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Thank you Malcolm, I wasn't really away, just loitering in the background in between dealing with a panic stricken eldest who decides he doesn't know any maths just before his GCSE exams!!!. I have to admit- I have missed BBT, and especially your "comments"!!!- but a bit disappointed that a few other UK staff haven't continued with discussions in the UK section.
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Hi Irene59, I have attached our SOP for out of specification testing, you could modify the table for all tests specific to your lab. Hope this helps oos for bbt.doc