In the UK we are required to report all transfusion adverse events/ reactions to the MHRA via the SABRE portal.

What I would like to know is if a patient reacts to some blood, this is investigated and no evidence of antibody involvement or indication of unit contamination etc found.Would you report EVERY suspected transfusion reaction to SABRE, regardless of the outcome of the investigation?

I suppose ultimately you would have to ask would the patient have reacted in a similar way had they not been transfused with a component at that moment in time.

Thoughts on how others are handling TR reporting to SABRE would be very helpful.

Thanks!

I think the clue is Serious Adverse Reactions and it is up to you as the HTT to define what is serious

In the UK we are required to report all transfusion adverse events/ reactions to the MHRA via the SABRE portal.

What I would like to know is if a patient reacts to some blood, this is investigated and no evidence of antibody involvement or indication of unit contamination etc found.Would you report EVERY suspected transfusion reaction to SABRE, regardless of the outcome of the investigation?

I suppose ultimately you would have to ask would the patient have reacted in a similar way had they not been transfused with a component at that moment in time.

Thoughts on how others are handling TR reporting to SABRE would be very helpful.

Thanks!

I agree with Joan, but am also aware of the fact that those involved in investigating issues on behalf of SABRE do take advice on individual cases, and where there is no evidence of antibody involvement (for example, in cases of hyperhaemolysis, or in cases of apparent reaction that turns out to be a sudden and drastic drop in Hb because of parvovirus infection, i.e. where there was an apparent problem with the transfusion, but there was actually more of a "coincidence"), they take a "relaxed view" of the situation.

:):)

What is the MHRA and SABRE? How do they define "transfusion adverse events/ reactions"? It sounds like a very broad category.

What is the MHRA and SABRE? How do they define "transfusion adverse events/ reactions"? It sounds like a very broad category.

The MHRA (Medicines and Healthcare products Regulatory Agency) is the U.K equivalent of the FDA, and perform regulatory inspections of Blood Establishments and 'for cause' inspections of Hospital blood banks.

SABRE stands for Serious Adverse Blood Reactions and Events. This is a mandatory reporting body which is run by the MHRA.

Definition of

Serious Adverse Reaction (SAR)

an unintended response in a donor or a patient that is associated with the collection or transfusion of blood components that is fatal, life-threatening, disabling or incapacitating or which results in or prolongs hospitalisation or morbidity.

Serious Adverse Event (SAE)

‘any untoward occurrence associated with the collection, testing., processing storage and distribution of blood or blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in or prolongs hospitalisation or morbidity

I think the clue is Serious Adverse Reactions and it is up to you as the HTT to define what is serious

I agree it is all in the definition. However, the fact that you are investigating a suspected transfusion reaction, which is thought to be serious enough at the time to report to the lab by the clinical teams , then how do you define this as not being an SAR?

Someone mentioned to me: would the patient have had similar symptoms had they not been receiving blood/ components?

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

Edited March 2, 201015 yr by Tonyd
icon

Thanks Tony, but I don't know how you decide a reaction was serious enough to report immediately if you don't have some of the serology results (specifically ones involving red cells). Also how realistic is it to expect staff to initiate a SABRE report - when they are trying to deal with sorting out the reaction investigations?

Another thing to consider is that the last SHOT report states that folk are still under reporting reactions. If we go by the suggested guidelines that classify a transfusion reaction- does this mean that SHOT want to be notified of all these reactions - but MHRA only want what we decide is serious?

Becoming even more confused than usual!!!!!!!!!

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

Edited March 22, 201015 yr by Tonyd

The other point I would make is that it may not be necessary to perform serological investigations on all ??transfusion reactions reported by the clinical area. It may be necessary to review the information collected at the initial phone call to the lab, follow a planned protocol, and then perhaps involving the TP make a judgemnet on whether there is a need to investigate further

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.

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.

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

and the MHRA are now putting together an 'expert panel' to review some incidents, so things may develop along that front.

Tony

The MHRA have put together an "expert panel" to review some incidents...

Guess who is one of the experts????????!!!!!!!!!!!!!!!!!

Be frightened, be very frightened!!!!!!!!

:hooray::disbelief:disbelief:disbelief:eyepoppin:eyepoppin:eyepoppin:fear::fear:

Edited October 3, 201014 yr by Malcolm Needs

Thanks Tony- that is very helpful.

I suppose I should be asking Malcolm to get a move on then??!!!!!

Thanks Tony- that is very helpful.

I suppose I should be asking Malcolm to get a move on then??!!!!!

You can always ask (but perfection takes time!!!!!!!!!!!!!!!! - ask my mum).

:haha::haha::haha::haha::haha:

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?