RR1

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.

Hi Mabel, If you go to www.slideshare.net - there are quite a few presentations available that might help. Also: www.traqprogram.ca select "RESOURCES" select "for nurses" scroll down to "canada" then "safe transfusion practice videos"

I found the following article below (which is similar to a report published in the current NewScientist ), concerning neonatal jaundice and autism/developmental disorder links; Study ties jaundice to autism risk LOS ANGELES — Researchers may have discovered a possible link between jaundice in newborns and an increased risk of psychological development difficulties, including autism. Danish scientists looked at data on the 733,826 live births in Denmark between 1994 and 2004. In that group, 35,766 were diagnosed with neonatal jaundice, a fairly common illness in babies that usually goes away within a week of birth. During the study period, 1,721 children were diagnosed with a psychological development disorder, and 4,257 children died. Being exposed to jaundice for children born at full term resulted in a 56 percent to 88 percent increased risk of acquiring a psychological development disorder and a 67 percent increased risk for infantile autism. The study was published online in the journal Pediatrics.

You have to also think about whether it is good practice to be increasing donor exposure for the intended recipient. If this is a cost issue -then you need to review how many paediatric units you hold to minimise wastage. If you have to issue these units- then leave them intact, and if the nurses complain-you explain this is the safest option. In the UK we are lucky that our Cryo is pooled by the blood centre during initial processing, but when we had individual 30-50ml units these were thawed and issued as 10-20 small individual packs and never pooled by the labs.

Thanks Tony- that is very helpful. I suppose I should be asking Malcolm to get a move on then??!!!!!

Welcome to BBT newBB, tell us a bit about which country/region you come from. Hope you learn lots from this site and share new things you learn, with us too.

I'm impressed STDUFFY626- you have your CEO involved as well!!!! Sounds as though you really have this well controlled- did it take long to get buy-in?

Thanks everyone. Does anyone know if MHRA, EU or whoever is going to do something with all the info on SAEs being collected ? It would be very useful to know what other sites are reporting otherwise, what is the purpose of this- if not to share and learn? I suppose more of the serious events are captured by SHOT f but it would be nice to have a summary from MHRA too.

Does anyone think that maybe we all go a little over the top with these rules sometimes? Is is 3 days or 72hrs? When does the clock start ticking- the moment you book the sample/request into the LIMS or the time sample was actually taken? Do you enter the actual time the patient received the first unit of blood, so your system/ staff know to the minute when a sample is no longer valid? If a clinician asks how long a sample previously sent is valid for- is this quoted to the actual day and hour? We need to keep this simple- KISS!!!! There will always be an element of risk with blood transfusions, but this has to be balanced with providing as good a service as possible and minimise disruption to both staff and patients. How many patients have really been affected when a sample did not meet exact , to the minute testing criteria?????

Useful extract Fluffy-thanks! , I hadn't defined the different types of GMP training we give- so will include on the next update of our training sop. Do you perform update training using examples of lab problems or just give a condensed version of the initial training?

May be this is just another term for a mega pos DAT??

Please could you tell me which staff groups you normally give annual GMP training . Currently we do our lab (Haem and Blood bank) and our hospital drivers. I also send the current presentation to the Path IT manager, Transfusion Practitioner and Path Services/QM. Next year for our lab folk we will be using the ORAS gold site for the GMP. Are there any other folks I should be covering with this training? Thanks!

Thanks for the info tricore- I'll certainly be ordering a copy to help format a Blood bank specific Q.Manual. I think this costs about $80 (£55) for non-AABB members and $50 (£35) for members. We currently have a joint Q.Man with the other Path disciplines - but unfortunately this doesn't really cover the the BSQR/GMP requirements and is rather long and boring. It would be nice to create a manual with lots of diagrams and flow charts explaining the systems in place rather than pages of unnecessary words. Another thing to remember would be to not include names of staff - but just their titles, as otherwise as soon as they leave, the manual needs updating- which would be very time-consuming.

Nice SOPs - many thanks DPruden and Dr Pepper !

Hi Mohandoss, welcome to BBT!

Welcome to BBT hvtimkang !

Of course the 30min rule is based on an adult size pack of red cells and really should not apply to paediatric red cells (50ml vol) used in the UK.

Hello Athur, welcome to BBT!

Thanks Jo and Eoin, unfortunately at some sites to get the message to the right people has to be through formal channels of escalation- otherwise this can re-bound in a very negative way, and can certainly damage relations in trying to establish trust between between lab/management .These problems are however made even more difficult when senior lab management perceive escalation as being "threatened" or when something is escalated- they tell you to sort it out yourself! Anyway- has anyone actually been specifically cited by MHRA for not having SLA with IT depts etc? As my quality/IT folk are not aware of any specific non-compliances being raised around our local hospitals they are not going to address this.

Thanks for the info Gregor, many of us are aware of how good Q-pulse is in managing these activities but unfortunately have to make the best of what we currently have. We use iPassport for doc control only but I know this has features for assigning CAPA tasks- but it actually seems rather more laborious than placing CAPA on an excel spreadsheet. I know many of these systems use email to remind folk of assigned CAPA tasks but this isn't of much use if your staff don't regularly read their email, sometimes it just helps to have a simple task list with due dates.

Hi Jo, thanks for the info, the folks I have spoken to are dedicated Path IT staff so they should be following the BSQR/GMP requirements and are aware of current risks of non-compliance regarding management of the LIMS. I just feel there is a lack of even wanting to understand the correct approach to upgrading,checking and maintaining systems properly. From what I have just been reading about ITIL, this is just good practice rather than a mandatory requirement, so if MHRA inspections can't improve buy-in from these folk then nothing else will !! The MHRA should be fine tuning their inspections to concentrate on these issues and this could also be helped by asking more in depth questions on the next BCR ( I could easily think of a good 10-20 questions I would quite like answered myself!!). As usual- these things are sent to try us!!

Great suggestions Eoin- thanks!

I have attached a Transfusion Reaction form that was forwarded to me by colleagues at Kings C.H, and that we have found very useful in our lab. LF-HAE-BT0008 TXRworksheet.doc

Does anyone suspect that hospital/ Path IT folk have not really bought in to this quality stuff- and that may be the MHRA should issue a guidance note of expectations for managing IT systems? Over the year I have forwarded VMP, change control, draft annex 11,PICs guidelines for IT systems etc- but i'm not getting an enthusistic response (surprisingly!!), it's as though path IT folk thing the BSQR does not apply to them, and I have also seen this in a few other hospitals too.....is this frustrating everyone else too?