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RR1

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Posts posted by RR1

    GAMP in a nutshell??

    in Education / Quality

    Posted

    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

    C-Section and the age of the pRBCs

    in Transfusion Services

    Posted

    haha: not yet, but one requirement states: does "A policy and procedure exist for blood and blood products utilized during caesarian section and open heart surgery. This is a French inspection.

    I was just wondering what they mean, is it the age, or what?

    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.

    Trending Incidents

    in Quality

    Posted

    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

    Trending Incidents

    in Quality

    Posted

    What worries me a bit Rashmi, is that your list only goes from A to L.................!!!!!!!!

    :haha::haha::haha::devilish::devilish::devilish::haha::haha::haha:

    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:p

    Cold Chain

    in Quality

    Posted

    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...

    Trending Incidents

    in Quality

    Posted · Edited by RR1

    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.

    Trending Incidents

    in Quality

    Posted

    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!

    Anti-C titer 0 (Zero)?

    in Case Studies

    Posted

    Goodness only knows, because the baby MUST either be cc or Cc. The baby CANNOT be CC. Therefore, using R1R1 red cells cannot mirror the in vivo situation

    y:

    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?

    irraditated PRBC

    in Donor Services and Donor Recruitment

    Posted

    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.

    Validation of Plasma Thawing System

    in Equipment

    Posted

    Many of us in the UK have had to move away from open thawing systems because of the potential risk of contaminating the plasma bags/ports.

    If you decide to send your water for cultures- what are you going to use as acceptance criteria?

    Staff have to take responsibility in cleaning these systems immediately on leakage and not leaving it to fester until the next time it's used.

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