Jump to content

RR1

Members - Bounced Email
  • Posts

    992
  • Joined

  • Last visited

  • Days Won

    6
  • Country

    United Kingdom

Everything posted by RR1

  1. Does the computer control the infusion rate and if the data is being stored does this need to comply with 21 CFR (I may have this wrong- as not completely sure of U.S regs), in which case the validation may need to involve testing computer data storage aspects ? The supplier should be able to help and advise what minimum testing is required for their products, or at least let you know what could happen in the worst case scenario with the individual pumps. If the FDA has a medical devices section they may also be able to help with validation advice. If the pumps have heating elements then possibly calibration certificates to traceable standards provided, and check of the over-temperature cut-off function, or just basic check of these devices working properly at different flow rates? Sorry- not that much help, just hope you don't have to test each one or there won't be much time to do anything else for the next year or so!
  2. Good point Malcolm. So why do we run so many controls, might it be that so many of our tests are manual and subject to human error rather than to do with the reagent storage conditions? Could it be that we all go over the top with these things...probably?? You know I REALLY LIKE the MHRA, especially after our last inspection, and will defend them forever (possibly)!!!!
  3. Thanks Pluto- I forgot that bit! The Orange Guide states that refrigerators and walk-in cold rooms should be mapped annually, and controlled room temperature storage should be mapped every 2-3 years and after any significant modification to the premises, layout or heating system.
  4. I'm trying to find out how people feel about quality systems used in their own labs. Do you generally understand the purpose- or is it bureaucracy gone mad? What are the good/bad points ? Thanks!
  5. With changes to Pathology services that is currently in progress in the UK, it would be really useful to know from our international colleagues what you would consider to be optimum staffing levels to provide an excellent and safe service for Transfusion, Haematology and Biochemistry. e.g Model: 400 bed hospital with obstetrics and busy Emergency Dept. Transfuse 10,000 Red cells 100 group and screens 500 Haematology Blood counts 500 Biochem tests As many labs in the U.S seem to use multidisciplinary staff, have any specific training issues been identified or difficulties encountered ? What has been the most useful piece of technology to assist? many thanks!
  6. Could your (U.S) Biovigilance folk help you with this? I'v never come across this before either and don't quite understand how you can benchmark transfusion reaction data. I'm assuming majority of your T.R's are not caused by lab errors/ missed RBC antibodies. Also, for what exact purpose does the Cancer Centre want the data for? Interesting post- thanks.
  7. We all at some time, receive complaints from medical/surgical staff about delays in the provision of blood components, especially during a massive blood loss event. Generally, on further investigation these reveal communication problems between the teams involved. In the last two years (2008-2010), if you can recall any complaints that your department investigated regarding similar problems, were these reported to SHOT/SABRE? Thanks for your help!
  8. Please could you vote for whether you temperature map your storage equipment ( for annual mapping only) in-house, using your own data-loggers and producing reports etc, or you contract an external company to perform this. many thanks!
  9. Cheeky so and so. As far as I know I am K-, but I suppose I could have typed incorrectly, that would certainly explain a lot!! Is there a nice long letter making it's way to the Newspaper / authors?
  10. They are probably ex-lab staff who were made redundant with the latest round of hospital mergers, due to their poor knowledge .....There's still hope for some of us then?????
  11. I have just posted info on these new areas on our local closed forum, so hopefully you may get some UK folk joining.
  12. Thanks aakupaku, it probably is best to monitor on the smallest component - as this will more likely be affected by temperature fluctuations. Some folk use Glycerol (different concentrations) or just water to monitor on, I don't suppose it really matters that much.Our proble was properly immersed, using a smaller bottle to hold the liquid.
  13. During temperature mapping of our fridges we have placed a temperature probe in 50ml liquid load to compare against the equipment 200ml liquid load. According to the results obtained the temperature within the 50ml volume runs about 0.5'C to 1'C LOWER than recorded in the 200ml load, depending on location. As we all seem to use a 200ml volume for "core" temperature monitoring, and especially in the U.K as recommended in BS4376, is this then really incorrect?? If we hold small 50ml volume neonatal RBC packs then it's possible that these could be stored below the 2'C lower temperature used in the UK, if the fridge temperature drops to 2.5 to 3'C. Should we all be monitoring our temperatures using smallest component volumes? It would be good to hear from others that may have performed similar comparisons too.
  14. If you are using automation then you need to stick to EDTA samples, too many problems otherwise. We have used EDTA samples for Years++++ and no problems- in fact I would say that manual grouping is much easier- no squishing around a clot trying remove some cells to group...and sometimes when you took the cap off, a great big "slug" of a clot would slide across your finger...URRRGGG!!!!!
  15. RR1

    Autoveu

    I think that Ortho sells various analysers using different Column Agglutination Techniques (Gel based or glass bead based). In the UK, what we refer to as a Diamed analyser is known in th U.S as the Ortho Provue and uses gel based cards. However, the analyser using the glass beads in the matrix is known to us as the Ortho Autovue. The analysers are quite different and it would probably be best to discuss this with the Ortho rep, who would be the best person to explain.
  16. But as it hasn't happened yet, the folk in charge of service transformations are not going to take this threat seriously. What MHRA needs to do is to step in PRIOR to serious destruction of transfusion services occurs. Of course, this could just be thought of as us "panicking" over progressive, and probably necessary changes that are needed in Pathology.
  17. Hi John, but surely a discrepancy like this,even though only in a screen should always be investigated, and in this case it was easily solved. However, in a different situation this could have led to failing to detect an antibody. It's good that Jeby noticed and questioned this, and I would have thought that our staff should always compare and question the screen reactions to the ID panel and be able to explain differences.
  18. Oh but Malcolm, I have it on good authority that regulation is not really any different to accreditation and we are all making a fuss about nothing. Bring on the days when CPA really does start to inspect the rest of Pathology to same standards.
  19. Malcolm, you're SO BAD! I hear they like this person up North VERY much !!!! Thanks adiescast, it is a little scary - especially considering folks making comments like this could be leading transfusion departments in the UK, in the near future.
  20. Going back to this old post.... is there really a NEED for a Transfusion Lead anyway? Could somebody who is multidisciplinary trained (but possibly not specialized in transfusion) not also take on responsibility for a hospital transfusion service which would include the regulatory stuff etc ? All comments welcome!!!
  21. Originally Posted by Malcolm Needs << Mistakes WILL occur, and when Trusts are sued, as is inevitable, the number of properly trained staff within blood transfusion will be examined in court - and I think that the hospitals will lose. I think, therefore, that, although the BMSs in Blood Transfusion are, at present, under "nuclear" attack, it will only be a short time before the MHRA steps in, and the short-sightedness of those involved will be obvious to all, and the correct balance between BMS and MLa (HTO/HHTO) staff will be re-established.>> Actually Malcolm, I can't see this happening for at least 10yrs, after which the majority of us with any technical/QA skills will have left the profession. Even the MHRA is going through staffing problems- and they certainly won't be able to keep up inspections to the level at which they began. With the impending changes being bulldozed through (and don't even mention "change control"!!) the majority of us will not even be able to maintain our incident handling systems, let alone teaching and training aspects- so an increase in serious mistakes will not be noticed within departments. Clever idea to close the NPSA around this time too don't you think?? I suspect haemovigilance reporting in the UK will be going downhill rapidly from this year onwards, especially as majority of managers that will be in charge of Blood banks will be someone with no transfusion background. Someone quite senior recently said to me that "transfusion is really simple now that we have Gel cards"!!
  22. RR1

    New Site Menus

    Looks brilliant Cliff!! This site is going to be so useful, especially now many changes taking place in the UK will require greater multidisciplinary training/understanding.
  23. If you look at the automated card visually is there any sign of agglutination- might just be too weak for the camera to identify, or is the well completely negative?
  24. Great presentation Colin, many thanks!
  25. Hi Jeby, We only use Diamed for manual techniques, so unfortunately I can't help you with the SOPs for automated running, but i'm somebody on this site could. Have noticed in another of your posts that your LIMS is Meditech, it would be a good idea to ask both Diamed/Biorad and Meditech companies to give you a list of other users with a similar set up, so you could contact the lab managers directly for documents etc. Have you repeated the automated screen-on the analyser, and if so are the results still different?
×
×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.