Jump to content

Recommended minimum standards for hospital transfusion laboratories.


Malcolm Needs

Recommended Posts

In the UK, the UK Transfusion Laboratory Collaborative, backed by the Institute of Biomedical Science (IBMS), Serious Hazards of Transfusion (SHOT), the Royal College of Pathologists (RCPath), the British Blood Transfusion Society (BBTS) and the Chief Medical Officer's National Blood Transfusion Committee (CMO's NBT) and equivalents in Scotland, Wales and Northern Ireland, has now published the "Recommended minimum standards for hospital transfusion laboratories" in various journals (two of which are Transfusion Science 2009; 19: 156-158 and The Biomedical Scientist 2009; 53: 744-745).

The implimentation of these recommendations will be monitored, as appropriate, through current Medicines and Healthcare products Regulatory Agency (MHRA; where applicable to BSQR 2005) inspections. The impact of these recommendations on transfusion laboratory errors will be monitored by SHOT reporting via the MHRA Serious Adverse Blood Reactions and Events (SABRE) reporting system.

This thing has teeth, and I suspect they will use them.

I am wondering how people are getting on with implimenting these recommendations, and how much support they are receiving "from above"?

:confused::confused::confused::confused::confused:

Link to comment
Share on other sites

For some hospitals however the the responsibility for ensuring compliance is forced down to the staff with the suggestions that if you can't cope with the regulations then you aren't suitable for the job. The 'resource' word isn't allowed. Goodness knows what will happen to staff at these places whene their CEO does actually get a talking to.

This UK collaborative document, which I do fully support however will potentially create an additional financial burden for BBMs on top of everything else- how much does it take for staff to finally give in?

Link to comment
Share on other sites

I know exactly what you mean Rashmi, but in circumstances where CEO's do get a "talking to", particularly where extra finance for the Blood Transfusion Department is required, the MHRA are quite capable of taking things much further (and higher), and have recently done just that in one of their inspections.

In the particulr case of which I am thinking (not public knowledge yet, so I can't name names) the BBM was given extra budget, extra powers and was promoted a KSF Grade (so it can work to our advantage).

:D:D:D

Link to comment
Share on other sites

Hi Malcolm,

I know exactley which hospital your talking about, we are urgently helping out 3 hospitals at the moment who didn't having any mapping and calibration in place and one in particular has had nothing for 3 years, it turns out the CEO has a very arrogant approach, and wouldn't spend any money, well he will now, as this particular hospital gets inspected next week, and will be close to being shut down, I agree the dept manager is brilliant and I have tried to help her and offer her support, she is hoping this will happen for her hospitals, and work to her advantage.

Cheers.

Dave (ABBWalker)

Link to comment
Share on other sites

I agree this is a positive outcome, but the emotional impact of this process on the BBMs of first having to go through these inspections and then the post-inspection trauma of trying to explain to significant people why things haven't been sorted - and told you just need to be on top of your non-conformances and sustain all other improvements. This can be very unpleasant.

Sometimes this all becomes soul destroying, and you want to give up but know that it's easier to work ridiculous hours and try to juggle everything than have to put up with the accusations and stress and the feeling that everyone thinks you are totally incompetent at what you do if you don't get through.

Have the BBMs at these other labs been given adequate moral support too?

Edited by RR1
Link to comment
Share on other sites

Hi Rashmi,

I think the problem is that most don't get the support they should be getting, with me looking in from outside it seems to be a very vicous circle and a dangerous game some CEO's are playing, I felt that sorry for one of these sites, I actually dived in and helped her out, and sort a particulary poor monitoring system company, (Invisible systems) on her behalf, I won't tell how I did it, but to say she was grateful was a positive result, and cheered her up no end, as it was one less problem for her to sortout.

Cheers.

Dave (ABBWalker)

Edited by ABBWalker
Spelling.
Link to comment
Share on other sites

Hi,

I've been asked by my CEO to prepare a report showing the risks and requirements to comply with this report. I will let you know what response I get once I have submitted said report!

Shirley H

:rolleyes::rolleyes:

Hi Shirley H,

I do believe I know you, do I not!

I would be heavy on the risks if I were you, with particular reference to who would be in deep trouble (the CEO) if the recommendations are ignored!

:D:D:D:D

Link to comment
Share on other sites

Hi Malcolm,

Indeed you do know me and have done for years!!!

I will be piling on the 'red' risks sprinkled with a few amber and maybe one green

Shirley

:):)

I thought I did!

Splendid plan, if I may say so, although I am foxed as to what the green could be!

I will say this much. I am fully confident that you already cover paragraph 3.6, because only ever get genuine stuff from your hospital outside core hours. If we get telephoned from your hospital during on-call hours, we know that we have something worthwhile to look at (wish I could say the same for the other 49 odd hospitals!).

Mind you, of course, if there is a rugby union international or test match cricket on the television, I (in any case) might not want to come in to work, but that's my fault for doing the rota wrongly!!!!!!!!!

:D:D:D:D:D

Link to comment
Share on other sites

Hi Malcolm,

Indeed you do know me and have done for years!!!

I will be piling on the 'red' risks sprinkled with a few amber and maybe one green

Shirley

:):)

Hi Shirley, some of us aren't 'allowed' to write risk assessments that might upset significant folk. I have submitted risk assessments where I was told it was exaggerated and it would be 'on my head' if there were problems caused by this.

It's great if your hospital is listening to concerns and taking this document seriously. I know of too many labs where this won't be actioned. I know too many BBM's that are suffering to such an extent that they are being made ill by inadequate support. How do we help these people now- not in another year or two?

Link to comment
Share on other sites

Hi Shirley, some of us aren't 'allowed' to write risk assessments that might upset significant folk. I have submitted risk assessments where I was told it was exaggerated and it would be 'on my head' if there were problems caused by this.

It's great if your hospital is listening to concerns and taking this document seriously. I know of too many labs where this won't be actioned. I know too many BBM's that are suffering to such an extent that they are being made ill by inadequate support. How do we help these people now- not in another year or two?

If I may jump in here Rashmi, the answer is that you cc your Risk Assessments to a competent body, such as the MHRA, or the IBMS (who have an excellent legal department) so that, even if you are seen as a "whistle-blower" by your own CEO, you will be legally protected (as long as, of course, what you are writing is reasonable, even if, in the long run, it is proved to be unfounded).

You have LEGAL protection, even if your "significant folk" don't like it. Indeed, if you know of a risk, and you do NOT report it, then you could be (almost certainly would be) legally in the wrong yourself.

Ignore this bullying. You have powerful friends in the MHRA and the IBMS (and the BBTS come to that, and, possibly, the NHSBT[????????????]).

:comfort::comfort::comfort::comfort::comfort:

Link to comment
Share on other sites

Thanks Malcolm. You would have thought that after three inspections these folk would know this needs to be taken seriously and resourced properly. I think there is a general lack of understanding by hospital folk of the the complexity of the transfusion lab processes, and how small errors can escalate to adversely impact on patient safety.

Also, the collaborative report states that depts have to be properly staffed for each function- this is so vague it can be interpreted by senior management any way possible that costs the least amount of money- all you do is tag on another role to someones job description.

Does anyone have a copy of the UK collaborative report that could be attached to this thread -so others know what we are going on about?

Link to comment
Share on other sites

No worries Shirley,

I wasn't about to name the particular CEO in person, I am not into naming and shaming, it just seems as though BBM's have a general problem with them not understanding how important it is to comply with the MHRA and how the implication could impact on any hospital.

In short it is far cheaper to make sure you comply and if you don't and something goes wrong, the cost implications would be considerably higher, it just seems common sense to me !

Cheers.

Dave

Link to comment
Share on other sites

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.

Link to comment
Share on other sites

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.

First of all Tonyd, thanks for the link.

Secondly though, I think that the MHRA are quite capable of using the recommendations indirectly where they think they should use them (they are pretty smart cookies).

The people who could really have looked at this, but who wanted nothing to do with the recommendations, are the CPA. If they could be persuaded to "come on board", I think that we would really be in business. I suspect that they may regret their attitude before long.

:frown::frown::frown::confused::confused::frown::frown::frown:

Link to comment
Share on other sites

Hi all, I was wondering what you all think of the qualifications needing to be mainly 'IBMS' accredited especially with Modernising Scientific Careers pulling the plug on the IBMS existence?

A few things trouble me...

1. the Edinburgh MSc is not IBMS approved but does contain the most comprehensive transfusion & transplantation elements in comparison to most of the others on offer.

2. I'm not entirely sure if the Bristol MSc is IBMS approved (on the IBMS list it has 'MSc Haematology' & MSc 'Biomedical science' but doesn't mention a specific transfusion one)

3. I've been told this will not affect NHSBT staff only hospital staff. This seems very odd to me - the experts in transfusion science do not need the same qualifications!? And we too have MHRA inspections...

4. for those with 'equivalent qualifications/ experience' how do they go about proving it? There was nothing in the guidelines to help with that.

How will hospitals be able to fund these qualifications & provide suitable training?

As a scientific trainer in the NHSBT I'd be very interested to know what we could do for you guys out there! We do run very good courses at the moment (wellI would say that wouldn't I?!) but we'd love to know what's missing/ needs improving... Any thoughts?

Link to comment
Share on other sites

Hi all, I was wondering what you all think of the qualifications needing to be mainly 'IBMS' accredited especially with Modernising Scientific Careers pulling the plug on the IBMS existence?

A few things trouble me...

1. the Edinburgh MSc is not IBMS approved but does contain the most comprehensive transfusion & transplantation elements in comparison to most of the others on offer.

2. I'm not entirely sure if the Bristol MSc is IBMS approved (on the IBMS list it has 'MSc Haematology' & MSc 'Biomedical science' but doesn't mention a specific transfusion one)

3. I've been told this will not affect NHSBT staff only hospital staff. This seems very odd to me - the experts in transfusion science do not need the same qualifications!? And we too have MHRA inspections...

4. for those with 'equivalent qualifications/ experience' how do they go about proving it? There was nothing in the guidelines to help with that.

How will hospitals be able to fund these qualifications & provide suitable training?

As a scientific trainer in the NHSBT I'd be very interested to know what we could do for you guys out there! We do run very good courses at the moment (wellI would say that wouldn't I?!) but we'd love to know what's missing/ needs improving... Any thoughts?

I probably should not be saying this, as I am a member of the IBMS Special Advisory Committee for Transfusion Science, but I do so agree with you about your first point. I am somewhat surprised that the BBTS representatives on the committee did not kick up more of a fuss.

I totally agree with your comments concerning the Edinburgh MSc (especially so, as I lecture on this course!) and, personally, I think that the Bristol MSc is its equal.

On the face of it, I would agree with your comments in 3, but when you look closer, some of the recommendations could not possibly be complied with by the Reference part of the Red Cell Immunohaematology Departments of the NHSBT (although this does not apply to most antenatal work and grouping for the armed forces or the British Antarctic Expedition). If, for example, you look at bullet point 2.1, much of our work involves the investigation of auto-antibodies (or rather, what, if anything, is underlying the auto-antibodies). there is no way that full walkaway automation (or any other kind of automation) could be used to perform these investigations.

Almost al of the other reference samples contain at least one clinically significant atypical alloantibody, and so the use of electronic issue (bullet point 2.2) is a non-starter for us.

I think, though, that many of the general points raised in the Recommendations are already adhered to by the RCI Departments within the NHSBT. Certainly, nobody could work as a Biomedical Scientist during core hours, let alone during non-core hours, unless they were registered with the HPC.

Point 4 is well made. Presumably, anyone who is taken on in this fashion would have to show capability and be signed off as such by the most senior member of staff within the Laboratory (and they themselves would have to have qualifications in Blood Transfusion), but I do agree that this should have been made more explicit.

As far as I am concerned, funding is a matter for the CEO, and, as I said in an earlier post, they fail to give the correct funding at their own peril. It will only take one disaster to occur, where the CEO is implicated for not funding the requirements listed in the Recommendations, and I think that funding will suddenly be coming out of our ears!

:cool::cool:

Link to comment
Share on other sites

One of the recommendations in the UK transfusion collaborative report states:

" To help facilitate compliance with the BSQR(2005), the requirements of a quality management system will be included as part of workload and service delivery"

How much (in BMS WTE) do folk think that a specific quality function is required to run a transfusion laboratory, additionally what is the function of a Transfusion Laboratory Manager ?

Link to comment
Share on other sites

One of the recommendations in the UK transfusion collaborative report states:

" To help facilitate compliance with the BSQR(2005), the requirements of a quality management system will be included as part of workload and service delivery"

How much (in BMS WTE) do folk think that a specific quality function is required to run a transfusion laboratory, additionally what is the function of a Transfusion Laboratory Manager ?

It surely must depend upon the size of the Blood Bank.

For somewhere like King's College Hospital, I would imagine that you would require an entire WTE for Quality, and the function of the Laboratory Manager is, quite literally, to manage (rather than go out on the bench). For little St. Elsewhere's out in the country, the Laboratory Mmanager could combine the two posts (although I don't think that is a particularly good idea - I think that the posts should be split, so that there is no conflict of interest) and the Laboratory Manager would probably spend quite a lot of time doing benchwork.

:confused::confused::confused::confused::confused:

Link to comment
Share on other sites

Thanks Malcolm, there are many variables in this. Do other transfusion Lab managers also take fiull responsibility for haemovigilance reporting or is this generally devolved to the transfusion practitioners?

Link to comment
Share on other sites

Having obtained my M Sc in Bristol in 2005 (M Sc Transplantation and Transfusion science) I can confirm the quality of the course. My question would be "Why does a keen BMS have to travel to Edinburgh or Bristol, both very lovely places to study mind, and not be able to get the equivalent in London"?

We have some excellent transfusion minds in London, why not a dedicated M Sc?

Link to comment
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now
  • Recently Browsing   0 members

    • No registered users viewing this page.
×
×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.