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Everything posted by RR1
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Not a problem adiescast....interesting that we are all experiencing similar problems with trying to improve our labs, regardless of which part of the world we are in.
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If only the rest of the hospital understood and adhered to good old 'Change Control'
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Sorry to hear of that Bill. In the UK it's not that our regulators are wrong about issues, in my experience our MHRA inspectors have been quite consistent in their citations and have always been incredibly helpful. The issue concerned is more of how some hospital senior management don't understand that to create and then maintain a robust quality system requires adequate resourcing at all times not just for a short while to deal with the non-conformances given at inspections, otherwise these will not be cleared. The fact that some staff are being informed that they personally will be fired from posts if they receive any major non-conformances at re-inspections,without management making any reasonable attempt at helping to progress things is unacceptable. Improvements in labs will certainly not be achieved by demoralising, demotivating, and frightening folk trying to achieve this.
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Please also indicate an appropriate response if the Quality Manager/ Officer is also under any of these constraints. Thanks!
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Coming back to the recalls question, would anyone have a template to use for recall of products/ components etc. I have attached my current one, but it is far too complicated to use and needs simplifying. Thanks! Recall and quarentine sheet.xls
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Further to this post....am I the only one out here that is trying to audit our SLAs, has anyone else included this on their audit schedule, or already performed this ? thanks.
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I have recently come into information that some Transfusion Lab Managers within the UK are being held accountable for clearing all major MHRA non-conformances regardless of the problems that have been noted with staffing levels, workload, maturity of the quality system etc. There have been noted 'suggestions' of these folk being taken down the 'capability route' . It may be useful for us to know to what level this is occurring. I would like folk to vote as honestly as possible on this poll so we get an accurate indication of any serious problems.
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PAS merges continued....... We are currently in the process of developing links with our Medical Records dept to have better control over the PAS merges. However the obstacle found is that there are many, many personnel in the hospital in various depts,that can merge these details on PAS, this is not solely controlled by M.R dept. I presume this is the same problem in most hospitals. Please could I have some feedback as to how others are managing to control this process Thanks
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It doesn't sound like you're moving the equipment very far, in which case keep the validation simple. Just check your temps are OK and test the alarms are working, and fridges sited correctly. For the centrifuges just check spin speeds and time settings have not been altered and everything is working. I presume you are in the US, in which case you don't need to fridge map anyway. Good luck!
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Thanks for the link David. Only a few more mega long documents and regulations to read through! Does this basically mean that if a fridge ( or air conditioning system) needs re-gassing then the maintenance company cannot use R22 gas (which would be in older equipment) as they are not allowed to store this, so you would need the complete gas exchanged to the CFC free one, or is there a change-over period? Is it possible to re-gas older equipment that uses R22 ? Thanks
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You're right ...I didn't realise how scrooge-like my comment was !!! Oh well, someone has to play the part.
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I am in the process of re-writing our SOP for out-of-specification testing. Just had a thought, if your ABO controls failed on the forward group you would have to retest ALL samples from neonates up to the last 'passed' control, as you would not have a reverse group as a 'check'. Also, this gets worse......if your corrective action showed that you needed to replace your LISS, capture indicator cells or other diluent , as this was found to be the cause of the OOS result (sorry Jules!!!!!!!), then all the screens up to the last 'passed' control would need re-testing. The more I think about this , the more complex it becomes am I going over the top with this?....aaargh!!!!
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What have I ever done, said, written or posted to upset you Rashmi??????????????????!!!!!!!!!!!!!!!!!!!!!!!!!!! :D:D:D:D:D:D:D:D:D
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Does anyone have details about the requirements for all fridges to be CFC free as of 2010? This would mean older fridges would probably not comply and actions would need to be taken to change the refrigerant in them- if possible. Thanks
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Hi Margaret, our BCSH guidelines are based on some aspects of SHOT. The SHOT team produce excellent annual reports ( a few of which are attached in the resource library) with recommendations for labs and clinicians to follow, though some of these very sensible points have still not been implemented even after many years. Also it would be useful nationally and even internationally to look at some of these SHOT recommendations (found at the end of the reports), and audit your practices against these. (easy to just cut and paste the matrix onto an audit template). Does anyone know how the US Biovigilance program is doing? Thanks
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Is this really 48hrs or 2 calendar days from time of issue ?
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Thanks Eoin, nice form . You seem to have some very good documentation and systems in place...I can feel a need to go to Ireland for a visit!
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Thanks everyone, I agree it does look like a separate manual would be the best, though certainly not the leanest way. What ever happened to integration? [QUOTE=adiescast;21149]And here in the US, we still have Thanksgiving...not that anything could be more important than the day Malcolm arrived into the world.
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You're 100th birthday by any chance????
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Thanks Malcolm, could be you're in a better mood because it's nearly Christmas??? I like the idea of a complete sub-section for transfusion, but in some ways this just makes the manual even more long-winded than ever. I haven't seen one that is less 30 pages yet. We need to lean these documents so they become purposeful, not just to please accreditation bodies.
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What are folks thoughts regarding the blood transfusion department having a separate Quality Manual from the rest of Pathology? When searching through the internet and looking at general Path Q. manuals, the transfusion sections are either non-existent (merged with Haem) or just a few lines with barely anything about the BSQR in them and purely written to appease CPA, which is important, but nothing really in them about patient safety etc. The Quality Policies also seem to be rather 'flaffy'. Theoretically the Q.S should be one system to enable integration, but is this realistic at the moment, unless of course if the rest of your Path depts follow all same GMP criteria to the same depth as for transfusion labs?
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Wouldn't it be nice if the procedures used in the U.S and U.K for this piece of equipment was the same ? We have been told that the weighing must be performed daily.
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Hi Sassa, I think everyones practices are slightly different. You need to write a matrix with each type of test you perform written down and beside this the associated positive and negative controls to run. In a separate column you could add the frequency of running each control and the actions to take if the controls fail. This matrix could be incorporated into a work procedure (SOP) that you could test your lab staff (engineers) against, to establish their understanding for competency. For the types of controls to use for each test, you need to decide, using manufacturers instructions/ inserts and by looking possibly through the AABB technical manual for guidance, the most sensible control for each particular test.
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Thanks very much for this Kate. It would be good if others could also attachtheirs too so we can can establish a good range of ideas, which I am sure will help many of us to further develop our forms.
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Hi Linda, We are required to perform res. volume check daily by actually weighing the strips for the ECHO and weekly for our Galileo. we regularly see weighing failures, and therefore need to repeat a number of times to show consistency and that we are not 'testing into compliance'.