Haemovigilance, Biovigilance, SABRE

[RR1]

It would be nice to here from folk of the types of serious events they are currently reporting to SABRE, we know that most of us are under reporting events.....but this is probably due to not having clearer reporting guidelines- something which I am sure will improve soon.

SABRE (serious adverse events and reactions) is the MHRA (FDA equivalent body) mandatory reporting system used in the UK, that all hospital blood banks and establishments have to report blood related problems to (since Nov 2005)

I gather that in the U.S. an equivalent 'biovigilance system' has been introduced. It would be useful to know the type of data this system will be recording, and any information given to staff as to the type of reactions/ events required to be reported.

Edited April 20, 2009 by RR1
typo.

[Eagle Eye]

US Hemovigilance is not live yet. Only few hospitals are reporting as initial validation process. Changes in the format will be done after initial data collection and review.

Once we go live we will be able to share the information. There were couple of session at AABB Montreal meeting whic has lots of information.

[RR1]

Thanks-do you know how long the initial phase is going to last?

[Eagle Eye]

Will look into it and get back to you soon.

[Ramir]

The patient part of the Biovigilance network will start this coming summer of 2009. The other part is donor vigilance and later I think will include tissues. See link below.

http://www.cdc.gov/nhsn/bio.html

Also another website that you might be interested in is the International Haemovigilance Network (previously known as European Haemovigilance Network). In their website, you will the haemovigilance programs and reports of european countries as well as non european to include Australia, New Zealand and Singapore.

www.ehn-org.net

Hope this helps.

It would be nice to here from folk of the types of serious events they are currently reporting to SABRE, we know that most of us are under reporting events.....but this is probably due to not having clearer reporting guidelines- something which I am sure will improve soon.

SABRE (serious adverse events and reactions) is the MHRA (FDA equivalent body) mandatory reporting system used in the UK, that all hospital blood banks and establishments have to report blood related problems to (since Nov 2005)

I gather that in the U.S. an equivalent 'biovigilance system' has been introduced. It would be useful to know the type of data this system will be recording, and any information given to staff as to the type of reactions/ events required to be reported.

[RR1]

One of the problems i'm having, possibly like a lot of other labs, is identifying what needs to be SABRE reported (especially for SAE's). So i'm going to begin a list of what I think / have read about are these events; maybe others visiting this section could also contribute or question these -

1. Incorrect patient bled- group discrepancy found on testing

2. Blood tags switched on units (same patient)

3. Blood issue/ satellite fridges holding units that have expired at midnight/ post 24hrs thawing for FFP or 4hrs for cryo.

4. Blood returned to issue fridge when otc for >30mins

5. Equipment failure - leading to incorrect results (though this is also Med Devices reportable)

I know there is some information on various sites SHOT/ OIG etc...but it would be helpful to have a list to work from. I know it won't cover everything- but it sure would standardise reporting of some basic events, and thereby improve overall reporting in the UK.

Please help with this

Thanks.

[Eagle Eye]

One of the problems i'm having, possibly like a lot of other labs, is identifying what needs to be SABRE reported (especially for SAE's). So i'm going to begin a list of what I think / have read about are these events; maybe others visiting this section could also contribute or question these -

1. Incorrect patient bled- group discrepancy found on testing

2. Blood tags switched on units (same patient)

3. Blood issue/ satellite fridges holding units that have expired at midnight/ post 24hrs thawing for FFP or 4hrs for cryo.

4. Blood returned to issue fridge when otc for >30mins

5. Equipment failure - leading to incorrect results (though this is also Med Devices reportable)

I know there is some information on various sites SHOT/ OIG etc...but it would be helpful to have a list to work from. I know it won't cover everything- but it sure would standardise reporting of some basic events, and thereby improve overall reporting in the UK.

Please help with this

Thanks.

I will add my thoughts

1)...I would investigate and if technical error at blood bank----report

2)...if I can reconcile or units not transfused---will not report

3)...doesn't apply to use we do have RBCs but do not store shortdates

4) ...this non no...it gets wasted and go under my STATS for wasted components but do not report

5)...would definetly report if patient harm occured or component transfused based on incorrect results

Please read our regs...Your requirement might be different than ours..

[Tonyd]

One of the problems i'm having, possibly like a lot of other labs, is identifying what needs to be SABRE reported (especially for SAE's). So i'm going to begin a list of what I think / have read about are these events; maybe others visiting this section could also contribute or question these -

1. Incorrect patient bled- group discrepancy found on testing

2. Blood tags switched on units (same patient)

3. Blood issue/ satellite fridges holding units that have expired at midnight/ post 24hrs thawing for FFP or 4hrs for cryo.

4. Blood returned to issue fridge when otc for >30mins

5. Equipment failure - leading to incorrect results (though this is also Med Devices reportable)

I know there is some information on various sites SHOT/ OIG etc...but it would be helpful to have a list to work from. I know it won't cover everything- but it sure would standardise reporting of some basic events, and thereby improve overall reporting in the UK.

Please help with this

Thanks.

Hi Rashmi

I would agree with all your points, except the first one. If an incorrect sample taken in the clinical area is detected by the laboratory QMS, then that is NOT reportable to the MHRA as I understand it, as there has been no error in the part of the process under laboratory control.

On the other hand if your QMS should have detected it but didn't, (ie someone ignores or overwrites a different historical group with the new one) then that IS reportable.

You will also be able to report this type of error to SHOT as a Near Miss when our new database is up and running later this year.

I would also clarify point 4 - if blood is returned to the issue fridge outside 30 minutes and is thus then available for issue to the same or another patient, then that IS reportable.

If it is returned to the lab, and doesn't go back into the issue fridge but is marked for disposal, then my understanding would be that it is NOT reportable.

I am sure that the SABRE helpdesk will have a view on these scenarios, and it would be worth running it past them.

Hope this makes sense - give me a ring if you want to chat about it.

Best wishes

Tony

[RR1]

Hi Tony,

Thanks for that. Maybe we need a checklist with lots of examples. I found a checklist/ document being used for the US biovigilance - Appendix F. Might be useful.

biovigilance usa.pdf

[Tonyd]

Hi Rashmi

I have tried to produce a similar list of definitions and examples in the SHOT toolkit, which is downloadable from www.shot-uk.org.

You should find the new SHOT database much easier to report to later this year, as we will take you through the proces; "Did something happen to the patient? / What happened? / signs and symptoms ?.....and so on...", rather than you make a decision on a particular category before you even make the notification.

The problem comes in producing a list on behalf of the MHRA, which of course we are not allowed to do as they are the competent authority under the terms of the BSQR, and their system is based on the premise that it is the reporter's opinion that counts as to whether something is an event or reaction.

Best wishes

Tony