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RR1

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Everything posted by RR1

  1. Are you referring to a current exercise or previous one that has already been submitted and closed? If it's a current one- then it really isn't appropriate to discuss this with colleagues, but to make your own conclusions from your local investigations, as you would do in the situation that this was an actual patient. Remember, the purpose of NEQAS is to test our systems and find potentially problem areas for improvement- not just to get the correct result. Might be an idea to record this as a quality incident for further investigating and checking your manual techniques vs automated- especially if the same Diamed system is being used. Was the sample tested on the analyser using cold LISS or screening cells that may have deteriorated? best wishes
  2. Hi pbaker-welcome to BBT!
  3. I've been reading through various GAMP (Good Automated Manufacturing Practices) documents - and these are quite long and detailed; i've been asked by senior management folk to write a brief document explaining the key features of these requirements- that would be simple to understand. So please help-not sure quite where to start!!!! many thanks
  4. Could this be a requirement to demonstrate that a policy exists for high risk procedures- and should cover caesarians and Heart ops? Number of units on standby or group and hold only (maximum blood ordering schedule) Are fresh (ish) units used for the heart ops or not? K- / CMV- for C/sections? Does the policy cover all clinical/lab staff actions in the event of a major obstetric haemorrhage/ massive blood loss event? Why not directly ask the inspectorate what they expect sites to have available- much easier then speculating.
  5. Thanks John and Donna, Useful points for capacity planning too.
  6. RR1

    Trending Incidents

    Further to this trending stuff, I am trying to learn about performing a Pareto analysis of our problems using the trending data. As far as I can tell, individual trends should be placed in % order of the total number (highest to lowest), and the incident categories that make up 80% of recorded problems are further analysed to direct more specific actions. Just wondering if anyone else uses a formal Pareto analysis approach to this...any advice on getting this right would be appreciated!!! Thanks
  7. RR1

    Trending Incidents

    Ha, Ha, Ha....I didn't think it would be appropriate to include M-Z as they were all various categories for NBS problems, with M trend = "Malcolm"!!!!!!!!! :p:p:p:p
  8. RR1

    Cold Chain

    I'm sure many on this site have temperature mapped their fridges and transport boxes as we have had to. According to (UK) guidelines/ Red book: Core temperature= 2'C to 6'C Air Temp= 2'C to 8'C Distribution Temp = 2'C to 10'C Does anyone know of a logical reason for these differences- especially with the distribution temp being up to 10'C (not that we used this for our validations)- and even some folks in the National Blood service don't seem to be aware of their own guidelines! Just confused...
  9. RR1

    Trending Incidents

    That's a very good point lucylou,I personally get a lot of satisfaction just looking at the nice colourful graphs! But seriously, at the moment we just review some of the reports of a particular trend to see if there are patterns. Recently, some of our process failures indicated that patient demographic errors were repeat events, and when we looked at each of these a bit more there was a theme of either clinicians incorrectly identifying the correct number of digits in the hospital record number when completing forms and labelling samples,or the lab entering these onto the LIMS incorrectly We have subsequently re-designed our blood request forms to make it easier for everyone to identify whether the number used is a local hospital number or a new NHS number (different number of digits) by just sequencing the boxes on the form in groups of 3 with a final single box for the 10 digit NHS number being more widely used in the UK. I suppose we should write a summary to explain tends for each category - which should reduce if the corrective actions were effective. There obviously has to be a risk based approach to doing this due to time constraints. I would find it very helpful to know how other handle their trending data too.
  10. RR1

    Trending Incidents

    Hi Jo and Eoin, thanks for sharing your trend codes, certainly helps with further developing our systems. Here are the categories I currently use: A=Equipment failure (all) B=Cold Chain failure C=Traceability Failure D=Process failure (Lab areas) E=Process Failure (Clinical areas) F=Complaints G=Recalls H=Concessionary testing/release I=Transfusion Reactions J=Quality System Failures K=Quality Improvements L=Audit Non-conformances. Some of my categories tend to overlap a bit- so I may need to further specify. Thanks for the ideas!
  11. Would it not be a good idea to mimic "worst case scenario"-especially in the case of a surrogate pregnancy, where the foetus may well be R1R1?
  12. RR1

    Trending Incidents

    Please could you tell me what categories you use to for trend analysis of your deviations/incidents/complaints Thanks
  13. How about: number of recorded incidents/complaints. Equipment breakdowns. % staff trained/ re-assessed within your defined periods. Length of time to clear audit non-conformances. % Patients wearing correctly labelled wristbands. % traceability figures (or time taken to obtain full traceability)
  14. Form attached that may be of use. TXR.doc
  15. Welcome to BBT Angela- and congratulations on passing your exams!
  16. RR1

    GMP Training

    Have attached the GMP presentation we used this year (from which the documentation extracts were from)- if of use to anyone else. May be others could also share their ones so we can build up a good pool to mix and match for next year? Many thanks! GMP2010 BBT.pdf
  17. If you use a Blood bank LIMS there should be a facility to add comments/ notes against each patient to alert you to known special blood requirements. It's a shared responsibility of clinicians, lab staff and even Pharmacy departments to ensure that any patient that is flagged as requiring irradiated blood due to particular conditions/drug regimes are managed properly and get the best treatment. We have a local agreement with our Pharmacy dept to inform us when they have dispensed Purine analogues, so we can update the special flags in our LIMS.
  18. RR1

    GMP Training

    Thanks for your input RoseM, I like your idea of using CAPA actions as part of your training discussion.
  19. RR1

    GMP Training

    I have attached an extract about Good documentation practice that we have used for this years GMP- if of any use. GMP_docs BBT.ppt
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