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Posts posted by RR1
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Don't forget to test thawing times for both largest volume and smallest bags.
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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
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He was a wonderful lecturer and made things really easy to understand- I feel privalaged to have attended one of his talks.
- Malcolm Needs and Michaele
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UK Guidelines for FFP attached, that may help with some of your questions.
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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 ££££ !)
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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.
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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.
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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.
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So much for quality!
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.
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Thanks for your info Malcolm, IVIg seems to have helped.
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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.
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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 -
To all,
If you are CAP inspected, AABB assessed, or your hospital is inspected by The Joint Commission you can file a complaint directly with them if you feel management is not responsive. If you are inspected by the above agencies the hospitals/labs are required to post the ways to contact them. If in the USA lot of the above are required to be reported to FDA as BPDs.
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.
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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.
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I'm discouraged
- same member of staff had set up a crossmatch again without a control being put up and also seems they don't ever put up immediate spin crossmatches
- not enough blood in stock for a 4 unit xm on a patient so just issued one unit. Then had the cheek to ask me why I hadn't put in an order for more blood. Pointed out, her patient, her blood, her responsibility. She ordered the additional 4 to come out on the afternoon delivery but didn't bother ordering any routine stock so now we have to wing it until the morning delivery or pay for transport...
- I came in at 12, said member of staff had done no authorising all day so as well as 6 haematology patients to crossmatch on my start I also had about 100 results to authorise
- same member of staff electronically issued normal blood on a patient requiring irradiated blood
Lots of incident logs for me to fill in today
I'm discouraged
Do you think that maybe the lab has some significant issues that need resolving? Just keep filling the incident logs- and ask to see the corrective actions (remember to keep a note of your incident reference number), as I know sometimes reports can go "missing". Every incident reporting system should be open to scrutiny by any member of staff. Sometimes as managers we don't always make the right decisions and it is good to have someone else look things over from a different perspective.
The error with issuing normal blood for a patient requiring irradiated- should be MHRA/ SHOT reported- also, the incident should be addressed by ensuring your LIMS prevents this happening- ask to see what corrective actions were done for this one.
Since you obviously care, then it may be that you have to set the cultural changes and standards in your lab.
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So folks, if a patient develops severe haemolysis (?? hyperhaemolysis) to a blood transfusion, I presme this would be reportable- even though not a factor of any error being made. Surely MHRA/SHOT should surely be collating this sort of data to see if there is a pattern in regards to patient treatment that may cause this to happen?
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On a similar theme, is it possible that hyperhaemolysis could be slightly different in a patient with sickle cell disease to one without this? ie, the Hb does not fall lower than the pre-tx Hb?
Also, could hyperhaemolysis be a result of the actual haemoglobinopathy- and the fact that many of these patients are on hydroxyurea?
I know of a patient that has haemolysed units transfused- but the Hb remains at the same pre-tx level. Investigations by the NHSBT reveal -no atypical antibodies by IAT, but there is said to have an auto-S (like) antibody by Enzyme. Even U- units have been transfused- but Hb is still not being maintained.
I think the next step is to transfuse using non-selected units and cover with IVIg. Lets hope this helps.
many thanks
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I particularly like the following from the report:
4.13.“A systematic approach should be taken to educating, training and developing the skills of the pathology workforce in quality managementsystems and quality improvement methodology, in ways appropriate to professional group, role and grade. This process should be led by HEE.We too often separate quality functions from everyday lab work- when in reality they are the same.I find I have learnt/ understood more about how to do my job with running the lab in the last 6 years, then the previous 13 as a BBM- and this has been due to our regulations and the way the inspectors have developed us ( a tough way, I admit- but that is what it has been), and it is all about considering patient safety and care at all times.Hopefully standardisation of all Path labs with the new UKAS inspections against ISO 15189 will further help. -
Thanks for linking Wayne,
The pdf was about 2.7MB Cliff- but it's easy to see via the link.
Many thanks
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Excellent report from the NHS England site from Dr Ian Barnes, released this week.
At last...... !!!
Sorry- guess the file is too large to attach- google NHS England
Report dated 28/01/14 :
Independent review proposes an upgrade of pathology safety checks to improve patient outcomes -
They'll STILL get you Rashmi!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Not that I'm biased against them, of course.
They are not out to get anyone Malcolm...... you know my thoughts on this!!! And, I've heard that your particular inspector is actually very nice.!!!!
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We also have the "too posh to wash" comments... .. staff who think it is beneath them to clean fridges etc- because they went to Uni !!!
It is all about culture.
- Auntie-D and Malcolm Needs
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They are however looking at time expired blood being available in the issue areas and units not re-stocked in time after these have passed reservation suitability date.
If the cold chain failure means that unsuitable blood is available for transfusion (ie taken out of fridge > 30mins and then returned to fridge instead of handing to lab staff, then I thought they were interested in these- because it shows a failure in proper control? If blood is out of fridge for >30mins, but is transfused to the intended patient within 4hrs (timing we use), then this is ok.
Thanks
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Do you think the standards have slipped because there are fewer dedicated Blood bank staff now- especially with folks being rotated between Haem and Biochem more frequently and introduction of 24/7 shift systems?
UKTLC Standards-ideas please
in Quality
Posted · Edited by RR1
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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