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Auntie-D

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Posts posted by Auntie-D

  1. My two pennies worth... I did measurement of uncertainty on KB - 47%. Shocking sensitivity... We changed our policy that any foetal cells required follow up by flowm while we were addressing the issue.

    We solved it by requiring all staff to take part in each EQA session and following up any discrepancy of >10%. We also introduced scoring for our controls and required all staff to do a count before moving onto the patient ones. Any discrepancies in the control scoring or EQA resulted in retraining.

    What actually happened was that because staff were required to do an actual count, rather than an eyeball, for every kleihauer, they organically became more proficient. We also were able to identify the staff member who was counting lymphocytes as foetal cells...

    For anyone who is interested - there is a modified KB that I have developed (sadly I never published before leaving the labs) that has a counter stain for the white cells - makes the foetal cells ping

  2. Not for anyone Rh neg - the instance is only 1% of the population. My uncle isn't allowed to work in China as he has a high-risk job and is O-Neg

     

    Edit - The ranking of ABO blood groups phenotypic distribution in China is O > A > B > AB. The proportions of A, B, O and AB type in China population are 28.72%, 28.17%, 34.20%, and 8.91%, respectively.

  3. I have issued 148 units of products to a guy who was cycle vs car massive haemorrhage - he survived. I have issues 120ish units on an obstetric massive haemorrhage (as well as 20 6-packs on the twins) - all 3 survived. I've issued similar on AAA (with eventual bypass) - survival. I think the key is to use TEG to see whether the clotting is screwed - if they are clotting then keep going... In the grand scheme of things blood is cheap

  4. Quality knobhead here - details are required on reports, not SOPs. ISO 15189 states that docuements need to have:

    a)        All documents are identified to include:

    —     a title;

    —     a unique identifier on each page;

    —     the date of the current edition and/or edition number;

    —     page number to total number of pages (e.g. "Page 1 of 5," "Page 2 of 5,");

    —     authority for issue.

    Information for users (ie lab handbook)

    The laboratory shall have information available for patients and users of the laboratory services. The information shall include as appropriate:

                      a)    the location of the laboratory;

    b)        types of clinical services offered by the laboratory including examinations referred to other laboratories;

    c)         opening hours of the laboratory;

    d)        the examinations offered by the laboratory including, as appropriate, information concerning samples required, primary sample volumes, special precautions, turnaround time, (which may also be provided in general categories or for groups of examinations), biological reference intervals, and clinical decision values;

    e)        instructions for completion of the request form;

    f)          instruction for preparation of the patient;

    g)        instructions for patient-collected samples;

    h)        instructions for transportation of samples, including any special handling needs;

    i)          any requirements for patient consent (e.g. consent to disclose clinical information and family history to relevant healthcare professionals, where referral is needed);

    j)     the laboratory’s criteria for accepting and rejecting samples;

    k)  a list of factors known to significantly affect the performance of the examination or the interpretation   of the results;

    I)     availability of clinical advice on ordering of examinations and on interpretation of examination results;

    m)      the laboratory’s policy on protection of personal information;

    n)        the laboratory’s complaint procedure.

    o) The laboratory shall have information available for patients and users that includes an explanation of the clinical procedure to be performed to enable informed consent. Importance of provision of patient and family information, where relevant (e.g. for interpreting genetic examination results), shall be explained to the patient and user.

    Reports however need to include:

    a)         a clear, unambiguous identification of the examination including, where appropriate, the examination procedure;

    b)        the identification of the laboratory that issued the report;

    c)         identification of all examinations that have been performed by a referral laboratory;

    d)        patient identification and patient location on each page;

    e)        name or other unique identifier of the requester and the requester’s contact details;

    f)          date of primary sample collection (and time, when available and relevant to patient care);

    g)        type of primary sample;

    h)        measurement procedure, where appropriate;

    i)          examination results reported in SI units, units traceable to SI units, or other applicable units;

    j)           biological reference intervals, clinical decision values, or diagrams/nomograms supporting clinical decision values, where applicable;

    k)         interpretation of results, where appropriate;

    l)           other comments such as cautionary or explanatory notes (e.g. quality or  adequacy  of  the  primary sample which may have compromised the result, results/interpretations from referral laboratories, use of developmental procedure);

    m)      identification of examinations undertaken as part of a research or development programme and for which no specific claims on measurement performance are available;

    n)        identification of the person(s) reviewing the results and authorizing the release of the report (if not contained in the report, readily available when needed);

    o)         date of the report, and time of release (if not contained in the report, readily available when needed);

    p)        page number to total number of pages (e.g. “Page 1 of 5", "Page 2 of 5”, etc.).

    These are the basic ISO requirements - Other standards may require further info ie JACIE/CLIA

  5. 19 minutes ago, applejw said:

    Is there any concern that the RBC is irradiated more than 24 hours prior to the transfusion?  Irradiated units will have higher K+ levels which could be an issue, couldn't it?

    We also wouldn't as we keep 6 packs for our NICU babies to reduce donor exposure (and also the amount of work needed for us when there are maternal antibodies) - Irradiation would mean we would need to recrossmatch every week

  6. Post it notes getting out of hand, losing track of pages in your notebook? Organise your to-do lists in here.

    Can anyone work out how to remove the completed tasks without actually deleting them (so they count in the numbers)? The 7-day thing seems to include complete stuff too and I can't make it stop :(

    To Do List Template.xlsx

  7. LIMS validation checklist -

    - that it won't let you issue ABO incompatible units

    - that it alerts you if you are issuing ABOD discrepant units

    - your antibody flags alterts

    - that it won't let you electronic issue if the patient has antibodies (it would issue as uncrossmatched not EI)

    - that it won't let you issue expired units

    - that it wont let you issue on one sample

    -  that it wont let you issue on an expired sample

    Much of this may already be in place but will need revalidating specifically to the electronic issue process. If any of these fail, or are not possible on your system them you shouldn't electronically issue.

  8. Ours are reviewed annually as some of the standards we work towards says 'Review shall not exceed 2 years' - and we all know how long it can take to get a document revised and approved. Our staff get issued with new revisions to acknowledge but are not required to re-acknowledge old ones unless there is an issue with competency. Any case where someone has a CAPA raised against them would be an automatic reissue of the SOP to read and acknowledge, regardless of the root cause.

  9. I've come across a new one so I thought I would ask you kind people for advice. I am working for a company that generates fit-to-work certifcates. What is the minimum information that would be acceptable in a footer for the template? I'm tempted by just document number and version but is that actually enough?

  10. On 10/28/2022 at 6:00 PM, Auntie-D said:

    It's Auntie-D back again! Cliff has kindly merged accounts :)

    I'm back but I am no longer in the lab. I'm a quality manager now full time. I've just moved to occupational health but have done a stint working with stem cells and ATMPs which was fun (JAICE is on another level). Current employer is thinking of starting up a lab and offering POCT/phlebotomy in mobile units - guess who's going to be project managing the whole lab startup? I took the job to get away from the lab lol

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