Tonyd

Yes, and that is the recommended method for quantitation of FMH in the UK.

Lol ! :haha:

Tell me about it !

Very true Malcolm, but that is because the particular FFP of which you speak is not classed as a blood component, and so does not fall under the requirements of the BSQR. It is a pharmaceutical blood product, ie a medicine, and comes under the provisions of the Medicines Act in the UK, which does not mandate blood group labelling requirements - again it is why it appears in the British National Formulary, whereas blood components do not. Best wishes Tony

Actually, SHOT have been collecting this very information - we now include a review of cases where transfusion is inappropriate and unnecessary as well as those where there is significant harm to the patient resulting from a failure to transfuse, or a delay in transfusion for whatever cause. I completely agree that we have to balance the clinical need for transfusion with trying to demonstrate 100% compatibility, and that comes down to an informed clinical decision based on consideration of the relative risks involved.

I would agree with keeping strictly to an Rh D match for Rh D neg babies, for all the reasons stated above. Ref the point about platelets not containing any red cells - yes it is true that component donation platelets (ie apheresis) have extremely low levels of red cell contamination, but remember that QA standards are that only a percentage of components are tested to confirm this, and only 75% of those tested are required to conform to specification - I certainly wouldn't take the risk of transfusing RhD pos platelets to a RhD neg baby unless I really had no other option. It's a shame that the Regulations don't allow us to remove the RhD type completely from labels of FFP packs, as that is one case where it really doesn't matter.

Thanks for this info Deny - unfortunately the site won't let me log in as I don't have a Hospital Red Cross number (or something like that), being in the UK. Does anyone have the pdf on file, that they wouldn't mind sharing ? Best wishes Tony

Hi Rashmi As per my previous reply, I don't think that many of these cases at all would be reportable to the MHRA, as they fall under the purview of 'the clinical area', so no pressure to get them on to SABRE. The SABRE help desk may have a view on this Tony

Hello Rashmi This is an interesting one, as the NPSA originally based their recent Rapid Response Alert on the provision of blood in an emergency (and recommendation to report) on unsubstantiated/uninvestigated rants from frustrated clinicians. You have to tease out at a local debrief/investigation whether the reported delay (for whatever reason) was an inconvenience or whether it significantly affected the patient. In cases where it is found that there has been mortaliy/morbidity related to a delay in transfusion, then these should be reported to SHOT in the 'catch-all' category of "I&U" - Inappropriate/Unnecessary/Delayed/Undertransfused. Not sure they are always reportable to the MHRA, unless you decide it is a failure of your QMS that has led to the delay Hope that helps Best wishes Tony

Perhaps not as 'asap' as Malcolm implied :-) ... but Haemovigilance is defined as "The systematic surveillance of the whole of the transfusion process in order to highlight adverse events and reactions, with the aim of improving safety of donors and patients" So, it covers everything from taking the blood in the first place, through processing, storage, transport, testing, issue, administration, and months or years post-transfusion too in the cases of viral transmission. You can imagine that the diversity of people involved in the process is immense, not just lab staff and clinical staff administering the components. We have traditionally looked at process errors of testing and administration, physiological reactions and infections in the SHOT scheme, but are now expanding our remit to include cases of over/under/inappropriate/delayed transfusions and are also hoping to include donor adverse events in our annual report, where people have fainted (or worse), have had allergic reactions to adhesive tape etc Hope that helps give a flavour of what it is about Best wishes Tony

It is good practice to commence the transfusion as soon as possible following removal from 'safe storage', but current guidelines in the UK do not mandate a specific time limit within which to start a transfusion, just that it needs to be completed within 4 hours of removal from safe storage From a pragmatic point of view, it seems absolutely stupid to waste units that may be started 40 minutes-1 hr after collection, but then completed within the 4-hour window. The key thing is that the ward should be ready to commence the transfusion before sending for the unit !!

Hi It is good practice to commence the transfusion as soon as possible following removal from 'safe storage', but current guidelines in the UK do not mandate a specific time limit within which to start a transfusion, just that it needs to be completed within 4 hours of removal from safe storage From a pragmatic point of view, it seems absolutely stupid to waste units that may be started 40 minutes-1 hr after collection, but then completed within the 4-hour window. The key thing is that the ward should be ready to commence the transfusion before sending for the unit !! With best wishes Tony

Hi Rashmi Many of the SAEs reported to the MHRA would fall into the SHOT 'Near Miss' category - at the moment the reporting of SAEs and SARs remains a legal requirement of compliance with the BSQR / EU Directive, rather than an exercise designed to produce feedback and learning, though the MHRA are analysing how errors in the widest sense seem to be made and how they can be avoided, and the MHRA are now putting together an 'expert panel' to review some incidents, so things may develop along that front. We have an annual 'data reconciliation' meeting between SHOT and MHRA, to ensure that we are picking up the same serious reactions, and so far we have been pretty close - MHRA will always look as though they have more SAR reports than SHOT, because they include events where the reaction was 'possibly' caused by the blood component (imputability score 1 ), rather than 'likely' or 'certain' as we use in SHOT (imputability score 2 or 3 ) Hope that helps a bit.. Tony

If it helps, we have a similar situation in the UK, where anti-D is defined as a medicine and should technically be under Pharmacy control. Because the transfusion laboratories have the expertise in dealing with the testing around anti-D issue (and more importantly are open 24/7, unlike most Pharmacy depts in the UK), we have found that Pharmacy are more than happy for the 'status quo' to continue, and in many hospitals have formally devolved responsibility to the transfusion laboratory via the medicines management committee of the Trust. The MHRA police both the Blood Safety & Quality Regulations and also the Medicines Act in the UK, and seem at the moment quite happy to let the current arrangements continue, as laboratories are not "supplying" the medicine direct to a patient, but are "issuing" it on the order of a suitable person who will then supply or administer it to the patient (ie a medical officer or registered midwife). Best wishes Tony

Sounds pretty theoretical. I'd rather make sure they got into theatre with a good haemoglobin, then perform Acute Normovolaemic Haemodilution coupled with a cell-saver. Our experience with pre-deposit autologous donation in these patients is that they get to theatre fairly anaemic and feeling pretty ropey - nobody does it any more in the UK unless it's an exceptional case with mulitple antibodies, when the Blood Service will perform it rather than the hospital.

There seems to be good evidence that exercise before donation can raise the platelet count, now whether that's a good or bad thing i don't know. We've had this question posed in the UK as to whether donors coming straight from a gym session can give blood, and the answer from our donor teams seems to be much as everyone else has said so far; - Make sure they're rested (at least 30 minutes, preferably longer) - Make sure they have had plenty to drink - Make sure they have had something to eat - Individual assessment at point of donation to make sure they feel OK

Hi Rashmi That's the kind of decision that has to be taken at DoH / Government level as it has all sorts of legal ramifications. The UK is pretty much alone in Europe in opting for the competent authority to be other than the established national haemovigilance organisation , but that's the way of it.

The short answer to that is that the MHRA and SHOT have different remits - SHOT to provide a comprehensive haemovigilance scheme with all the feedback and learning that entails, and the MHRA have a statutory duty to feed figures related to the BSQR back to Brussels every year and to check that CAPA are being performed. SHOT reporters clamoured for years to have an electronic reporting system, then the MHRA allowed us to piggyback on to SABRE, so reporters got what they wanted. Then they asked for electronic SHOT incident form completion, rather than the old paper forms, so we devised a new SHOT reporting database - again reporters got what they wanted. It may not be perfect, but any new system takes time to get used to and to 'shake down'. Hopefully you will see the benefits of the new system in terms of enhanced feedback, and if you want to use a 'lean' analogy - added value :-)

Hi Rashmi The bottom line is, if a reaction means that you have to discontinue a transfusion and perform some further clinical intervention (beyond simple administration of anti-pyretics or anti-histamines), and/or that results in prolonged patient stay, then it is serious enough to report (to both SHOT and MHRA) It is nothing to do with serology results at all - those will give you a clearer picture in due course as to whether the reaction was actually linked to the blood component or not, but have no bearing on the need to report the reaction in the first place. Regard it as yet another opportunity for clinicians and BMSs / TPs to engage and decide on a sensible way forward rather than rely on proscriptive guidelines that can never hope to cover all eventualities. :-) I take your point as to the practicality of reporting immediately, but it is a legal requirement under the terms of the BSQR and the MHRA do look at 'late' reporting, and perhaps another reason why the haemovigilance reporting load should be spread round more than one person in a trust. The point about SHOT under-reporting is that we know that some places are not reportiing ANY reactions, never mind the serious ones - we have feedback that some clinical areas (in neonatology, for example) are 'dealing with' complications of transfusion without ever informing the laboratory. If you report to MHRA, then copy SHOT iin as well - we want to know about exactly the same kinds of reactions that they do. Tony

The whole point of the BSQR reporting system is that you have to by law notify the MHRA via the SABRE web portal (It's a web-page, not an organisation!) of any reaction you deem serious enough to meet the definition as soon as practically possible after the event (ie usually before you have managed to do any investigations on it) It may be that on investigation you decide that the reaction was not in fact anything at all to do with the blood, but a coincidental occurrence. Following your investigation, you log on to SABRE again and submit a comfirmation report, in the course of which you assign an 'imputability' score as to the likelihood of the reaction being caused by the component. You can't withdraw the incident, but you can indicate by this imputability score whether you believe it is linked to the transfusion. Hope this helps clarify things

I suspect you are right, Malcolm - it is VERY easy to interchange the two frameworks, and it leads to confusion.

Unfortunately nobody has bitten the bullet and set out this type of definition, Rashmi - it could vary between departments depending on equipment, automation/robotics and use of electronic issue, for example. The MHRA have 'commented' on the fact that one TP ( not 'SPOT' !!) cannot effectively cover a Trust with 'x-thousand' employees, but unless there is evidence that work is not being done or is being performed unsafely they seem unlikely to push the matter. Tony

Sorry about that - must have got corrupted in the posting

Hi all Here is the link to the freely available downbload of the Collaborative recommendations; http://www3.interscience.wiley.com/cgi-bin/fulltext/122573960/PDFSTART?CRETRY=1&SRETRY=0 The MHRA cannot inspect directly against these recommendations (and have gone on record as saying so), as they do not form part of the BSQR. However, they may well utilise them indirectly as support to the BSQR requirement for 'suitably qualified staff' to operate a transfusion service. Some hospitals, in the NW for example, have performed a Gap Analysis with regard to their compliance and after initial resentment at 'another set of things to comply with', are surprised and pleased to find that in most cases they are already well on the way to meeting the recommendations. Building these recommendations into risk management/governance processes within Trusts is definitely the way to go - in the end the Trust has to accept the risk that the staff it employs to run the transfusion service are fit for purpose.

Completely agree, Franklyn - some folk would have you doing a RCA for wearing odd-coloured socks these days, it seems and you have to wonder about the time and resources allocated to some of these. (On the other hand of course, some are not being done for serious incidents that really do warrant a full investigation..)