RR1

As some of you may know the UKTLC are reviewing the current 2014 standards. If you have any suggestions on what might be useful to include, please let me know many thanks Rashmi

Don't forget to test thawing times for both largest volume and smallest bags.

Has anyone (Path labs) in the UK been inspected by UKAS against ISO 15189:2012 stds yet ?- Just wondering how these inspections are compared to the previous CPA ones. Thanks

He was a wonderful lecturer and made things really easy to understand- I feel privalaged to have attended one of his talks.

UK Guidelines for FFP attached, that may help with some of your questions. j.1365-2141.2004.04972.x.pdf

We use to have this problem quite a lot- and realised that the heat exchangers were getting iced up and the temp started rising. So now we defrost every 2 months as part of the deep clean schedule ( of course this was after getting the engineer out to fix quite a few times... and as it had been turned off overnight, everything was always fine when he arrived- just cost us ££££ !)

John, I think that many Blood banks in the UK now have automation and provide blood by EI . The workload increase has come about with the introduction of the Blood Safety & Quality Regulations in 2005, and having to have a proper quality system in place, which some labs had to absorb as part of the normal workload without a proper quality structure for Pathology. Managers not only had technical, financial and HR responsibilities but a full QMS to deal with too without adequate support. There are sites which up to a few years ago had no documented training records, SOPs, , audits , change control, validations, let alone incident reporting to the depth we now need to do this. Haemovigilance reporting in the UK (SHOT) has for 20 + years reported that upto 50% errors causing patient harm originate in the lab- but still many labs were/are not addressing these issues (or even reporting!). Issues with staff culture is also a significant factor - and some people are resistent to improve.

I think you are probably right Malcolm,but at least the requirements will be documented, and if not adhered to and we can't sustain our QMS activities... then I suspect the regulators won't be very happy chappies!! I hear the MHRA are now beginning to give Major non-conformances against staffing levels being minimal leading to staff being overloaded and there being a risk to quality........only a matter of time for these to be raised as Crital deficiencies if significant folk don't listen.

To look at this differently- could it be that we all have so many other tasks to do now that we don't have time to do anything properly? I can't remember having to clean fridges when I was training - I don't think we even considered these things before regulation! though I have probably cleaned more in my BBM role than ever before... I don't remember having to accurately trace blood units,let alone read SOPs (they didn't exist!), auditing, and what was Incident reporting?? .Though I do see the need for all of these activities and they do make sense. I am in the process of writing a staff capacity plan to obtain more staffing (!!!) and this really shows where the gaps are in our lab activities; if we weren't all trying to juggle so many tasks, performance would improve, but, I do agree there is a need for a lot more professionalism to be shown by some staff.

I agree, but we are going through a cultural revolution now in the UK- so in a few years time things could be much better.

Thanks for your info Malcolm, IVIg seems to have helped.

We don't at the moment Mabel. Our HEMS team initially use Tranexamic acid to help with the bleeding before they start transfusing red cells.

Perhaps this reference may help ? from the attached FMH (UK ) guidelines Samadi R, Greenspoon JS, Gviadza I, Settlage RH, Goodwin TM. Massive fetomaternalhaemorrhage and fetal death: are they predictable? Journal Perinatology 1999; 19(3): 227-9 BCSH_FMH_bcsh_sept2009.pdf

Would this not be considered as Whistleblowing in the U.S ? In the U.K - this is what it is classed as and even though the reporter should not be punished for highlighting problems, there are very few staff who still have a job afterwards.

We also need to factor in maternal height/ weight (BMI)- which we have never done before in the UK, and this too could affect efficacy of the dose administered. I know there is new guidance on this issue.