RR1

Our staff are growing so weary with workloads and trying to keep up with changes that they see quality as a 'dirty' word just invented to make their lives hell, when in the long term if performed properly (with fun), this will ease and streamline every lab function. There are places that are not 'doing quality' using lean- six sigma principles and correct tools. It's the responsibility of ALL transfusion manager, senior staff and quality people to introduce and develop these concepts, or we will just turn our staff away from this all. Lean/ Six Sigma Quality = FUN

Far cheaper than a lawsuit....and as for traceability??

I think the best test is to compare agglutination strengths of weak antibodies. I am sure the various suppliers would give you free samples to try out. Look forward to your validation results. I must admit that I don't take that much notice these days of what manufacturers say about their products, just need evidence from my own testing.

Do your suppliers not produce donor collection bags with paediatric satellite packs attached, so that when a small volume of blood is required you could directly transfer via the closed system , the volume required and detach this from the main bag? Would solve all these problems- and probably be a lot safer.

What...not even a teeny weeny bit Malcolm????

Thanks Jo, but you have to admit it's a bit boring??...couldn't we try and make it more memorable- and possibly even fun (is this possible) ?

These manufacturers imply a lot of things but now-a-days I go with what our inspector said: If it's not written down....it's a rumour.

Do you mean the use of 2 x D reagents or the fact that there is a weak-D test function? I have to admit I feel happier with 2 x D reagents just in case one was contaminated by splash over in reagent dispensing. The grouping on Galileo and ECHO is liquid phase in microplates where there is more potential for cross-contamination to happen. We don't routinely weak-D test our negative reactions in the UK

Hi Cathy, I think the daily WBcorQC for the ECHO is similar to the test run on the Galileo, and that doesn't have a strength of reaction to be graded. I personally find this test fairly meaningless. Ask yourself what is actually being tested by running this control? It would be safer to run 'bog standard' A, B, O controls that give you clear blood group interpretations that everyone understands. However, as this is a recognised control for the analysers, and failure of this would, I presume, prevent the equipment from working (??) until an accepted test is passed you would need to continue using it (unless you risk assessed this). We currently use whole blood ABO Albacheck controls as recommended by Immucor (UK). Also run our own weak antibody controls (anti-Fya, -S) in addition, even though Immucor say this isn't necessary as each 3 cell screen has a pre-bound control on the end ( saying that I have NEVER seen this pre-bound control fail). Question all the controls that you will running (or not) on this equipment until you understand and are happy with exactly what reagent and part of the test is actually being controlled.

From what you have described, your conclusions seem to be likely that a donor was mistyped. Can you ask for the lab to re-type the donors with fresh samples, or It could be that they misinformed you and meant to say that the donors were O and A ? Would your consultant need to clarify this in case a mistake had been made...but then I suppose if the HLA types were not matched the transplant would have failed.

Yes I know this is the problem, but folk still have to stand up and do the right thing or it just means everything we do is superficial and worthless if we carry on submitting manipulated results.

Gosh...don't we all know this!!!!!- but it shouldn't prevent us from doing the 'right thing'.

If only we could write that!!!!!! I will have a think about the rest...as you say, it may work as a couple of lines per area. Thanks!

You would need to formally validate the plastic tubes against your current glass ones. Write a matrix with all the tests you currently perform together with the criteria you are looking for in each test ( ease of dislodging cell button, ease of visually reading the reaction, differences in titres of weak antibodies, etc) and compare this same criteria for the different tubes. If the plastic tubes show reduced performance then you also possibly need to write a risk assessment of what could happen if you are made to switch these tubes. Though I suspect the validation may be quite clear in showing these risks.

Hi Andrew, welcome to BBT

Thanks Terri, aren't folks meant to be able to recite their quality policy...or am I getting this mixed up with the 'mission statement', and if so ...where does this statement belong? Our current Q.P is one page long with about 14 lines, but as this was a shared department thing doesn't include any of the transfusion specific regs or goals

I would have also thought that if this was anti-IgA the reaction would have been more observable with the plasma and platelets, and fairly intense too. Do you have the Hb and Bilirubin results to see if any destruction could be occurring?

What other results did you get: Pre and Post Hb, Pre and Post Bilirubin. Also what technique and method are you using for all the screening performed?

Hi rajendraksaini, are performing a forward and reverse group? also do you run a reagent control antisera with the test?

Is there any specific reference that indicates exactly what a quality policy must contain? Some places have such long winded policies I don't suppose any member of staff actually knows what it's about. What is the exact purpose of a quality policy? Why can't this be a couple of lines long? Thanks!

Thanks Bill, we have started to set questions against the SOP's , the difficulty is trying to get them back in a timely way. My last set of questions was to address one of our MHRA non-conformances in that not all staff working on shift were familiar with the QMS documents. I managed to keep this to approx 20 questions set against 8 sops and policies, it was a bit easy, but at least they had to go through the docs and also sign to say they read them.

If these are handled correctly through the non-conformance system and a root cause determined and problem dealt with (or resources requested!!!!) to resolve, then this shouln't be a problem with anyone else, as long as there is documented evidence for this all.

Does anyone have a foolproof way to get their staff to read all relevant SOPs and policies? Thanks!

Malcolm, just to feedback on your comment , we told our MHRA inspectors during inspection that we had recently 'failed' a NEQAS exercise with a missed antibody detection, and they were fine about this......the regulators didn't 'get us' ( well not for this anyway...!!!!!).

I think we need to produce a list of weekly tasks with the hours assigned to complete each one to the appropriate level to begin with .We could then work out individually how many hours of staff time are available , and average these out for our own labs. At my lab the staffing on paper looks quite good until you actually work out that all staff on the shift system are really only in the lab during core hours (09:00 to 17:30) for 65% of the time. There is no slack during any of the 'shift' periods to perform any significant amount of routine tasks other than group,screening and crossmatching. The BSQR is improving practises and patient safety in the short term, but the loss of highly trained people from the profession will happen because nobody will really want to take on the responsibility anymore of trying to achieve and maintain compliance in an under resourced lab with ridiculous and unrealistic pressures put on them. This will contribute to an increase in serious incidents in the coming years.