Auntie-D

So POCTs and clinical software are now classified as medical devices by the MHRA and subject to full validation - yay! We are OK in the labs as it's normal for us but it's going to be a steep learning curve in healthcare...

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

and semantically they asked about products

OK Question for you... I have always reactivated accounts to LIMS and QMS if the leaver has returned whilst still under technical competency (up to 2 years). ISO 27001:2016 - A.11.5.2 User identification and authentication Control - All users shall have a unique identifier (user ID) for their personal use only, and a suitable authentication technique shall be chosen to substantiate the claimed identity of a user I have interpreted this as "as long as we can confirm the identity of the staff member (which we can), then there are no issues with reinstating their login. Having one person with two logins recorded against them means there is no longer a unique identifier for that person and we may potentially be seen as non-compliant. By giving someone a secondary login we lose traceability from an audit perspective and also regarding competence. Which would require the staff member to undergo full re-competency for the role as there is nothing recorded (our competencies are managed within the QMS). New IT person has just said "No - GDPR!" - our DPO said there are no GDPR issues but it has got me thinking. Have I interpreted the standards incorrectly?

I worked in a rural lab for some years - with a recruitment and retention premium of one pay band higher

If you don't follow the manufacturer's instructions you have to validate, instead of verify for use - easier to use theirs...

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

I'd use measurement of uncertainty as per ISO 15189

What age range are you talking about - when I was in a paed hospital the cutoffs for under 5s were much higher (ie early transfusion) if the Hb was low enough to cause cognitive issues, or depletion of B12/folate from natural replacement. For neonates higher still.

GEM all the way! It's so user friendly - instruction videos of how to use it can be played. GEM has everything else too - ISEs, carboxy Hb etc Just make sure you lock permissions so the users can't eject the cartridge - not much fun when they waste 1000 tests due to pressing the wrong button. The best thing about Werfen is they are an up-front company. There was an issue with the potassium (i think) which affected 1:100,000 tests, so they remote disabled it until it could be fixed. Much better than a certain company who has known issues with their Troponin (1:10 false positive ish) and their solution is to rerun all positives. Yeah cause that's an ethical way to go about it.. Anyway rant over - GEMs are great!

Technically RBCs are not prescribed so can be ordered by anyone who has demonstrated competency. (UK)

I just answered this question. My Score PASS I cheated a bit in that my first job had a biobank attached to the transfusion lab

Hi all I was a member here several years ago but had not been able to access my account due to signing up with an NHS email address - duh! I'm now back... I'm no longer in the lab - Covid broke me! I broke out of the lab (and lab quality management) into HSC Transplant, specifically ATMPs and CAR-T QM. I thought MHRA/UKAS was bad - Jacie - WOW!! I've recently moved to a national occupational health company - I thought I would have a quiet life; no such luck! I'm now doing a QMS rebuild (Q-Pulse) and preparing for ISO9001/27001 in March, and also ISO 13485, IQIPS (based on 15189) and SEQOHS. Exciting times - I get to build Q-Pulse exactly how I want it... I'd rather switch to RADAR but that's a long term plan. I've also found out I may not yet be out of the lab. They are thinking about opening a brand new lab and mobile POCT units - which I will project manage. Major change control done right Exciting new role for me with lots of challenges ahead. I'm glad to be back

In the MHRA inspection I had when I was BBSup I challenged on 4 different non-conformances and had them wiped off. My current employer (and others too) seem to think that you cannot challenge their interpretation of your policies - and sometimes the interpretations are incorrect.

ISO inspectors have said the fridges have to be under direct control of the lab - a few labs I know have been told to remove their remote fridges.

POETS day is a good one... All the managers covering the lab so staff can go an hour early on a Friday.

In the UK we are forbidden from having remote sites now. We have O-Neg, CMV neg, K-neg, HEV neg, units. We do not have irradiated units, or less than a certain date as we do not have babies who have undergone IUT, and if we do we are notified in advance and we get irradiated units in for them.

Surely it's just common sense not to accept it? The tech on duty needs a rocket up their bum!

We've given a patient an anti-D with apheresis platelets - fortunately a man, but unfortunately he then went on to be transfusion dependent, meaning full crossmatch and no electronic issue possible This was within the past year so it certainly still happens. We would only give anti-D to patients of childbearing potential and we keep one unit in stock of APos in case of massive haemorrhage/urgent need

Not in Micro any more but we used to add 2ml, shake and then centrifuge the liquid. We would then remove the supernatant and use the remaining pellet.

Could it be the modified KB that is being developed? If you do a KB then dip in Geimsa for 5 seconds it stains the nuclei making it easier to differentiate between lymphocytes and foetal cells.

Are there two Joyce Pooles? My transfusion lecturer at uni went by the same name. She wasn't famous was she???

I'd say the fact that you are getting so many calls means that either training/competencies aren't up to scratch, or the SOP is lacking. You say that the tech had signed to say they were competent in the task - who had verified this? It sounds like you need to look at your own management, rather than blaming the techs. I've been in the situation you are in as a young supervisor with people who are older (and more experienced in terms of years) below me and it is a hard place to be. Ironing out the issues with poor performers is the hardest thing to do and the only way to do it is with good competency-based assessments. Another thing to consider is including a list of changes when putting a new SOP out - you will find that 'old-timers' think they know the SOP so won't bother to read it (I've been guilty of that myself). Another thing I did was introduced an hour a day for each section where one person (on rotation) could spend the quietest time of the day (usually 11-12 or 2-3) getting up to date with any outstanding training. It meant that everyone (in theory) got an hour a fortnight. Do keep in mind that how they perform, and your response to it, will reflect directly on you - it's a good idea to keep them on side and make sure competencies are absolutely spot on. Anything that isn't can be brought up at their appraisal as a goal for the next year (not a stick to beat them with). Help your staff, keep them happy, and they will start having the confidence to trouble shoot themselves without fear of reprisals or looking stupid. You could really make something positive out of this situation and get brownie points for it in your own appraisal.

I've looked into this as the UK imports some of its Frozen Products for the US - as the virus is lipid encapsulated methylene blue should deactivate it, so there shouldn't be any worries with FFP/cryo/Octoplas etc. Remington KM, Trejo SR, Buczynski G, Li H, Osheroff WP, Brown JP, Renfrow H, Reynolds R, Pifat DY. Inactivation of West Nile virus, vaccinia virus and viral surrogates for relevant and emergent viral pathogens in plasma-derived products. Vox Sang. 2004 Jul;87(1):10-8

We only reflex to a confirm if the screen is positive. If the LNR is >1.2 we then report as "Possible Lupus anticoagulant, please repeat in 12 weeks for confirmation.". This eliminates any acute phase patients which may be falsely positive - they aren't the best with the clinical details.