Frequently asked questions relating to SABRE

Incident reporting
Can donation numbers be included in a SABRE report without breaching confidentiality?
MHRA has obtained legal clarification on the subject of donation numbers. As a donation number on its own neither identifies the donor nor the patient, there can be no concerns about a possible breach of confidentiality. Donation numbers may therefore be included in your reports. However, you must ensure that patient and staff names and patient ID numbers are removed from reports, attachments and footnotes before submission.

Which serious adverse event category should I use?
Help is provided on page 6 of the Background and Guidance on reporting SAEs and SARs (51Kb). The further explanations below may also be of assistance.  If you remain unsure, contact the SABRE helpdesk for advice.

• Whole blood collection - Refers only to the collection of donor whole blood and not to the collection of patient samples.
• Testing of donations - Refers only to testing of donation samples and NOT to compatibility testing on patient samples. SAEs involving compatibility testing should be reported under 'Other'.
• Processing - Refers to the manipulation of blood and components by a blood establishment only.  It does not refer to the “processing” of patient samples in the HBB.  SAEs involving patient sample testing should be reported as 'Other'.
• Storage - Refers to all stages of the storage of the blood and blood components including storage during distribution, during delivery and the placing in and removal from a storage device.
• Distribution - Refers to delivery errors between blood establishment and blood establishment, blood establishment and hospital, and between hospital and hospital.  It does not refer to delivery failures between two areas of the same hospital.  These should be reported as storage errors.
• Materials - Refers to any SAEs caused as a result of the use of deficient materials.  This can be faulty equipment, test kits, blood bags etc.  You should also consider whether to also report to MHRA as a medical device adverse incident.
• Other - Refers to any adverse event that cannot be categorised more specifically.  It is accepted that many SAEs fall outwith the definitions of the other categories, especially for HBBs.  Once further data has been collected, the MHRA may consider sub-categorising this category.

Who is responsible for reporting to MHRA?
The Regulations place a legal responsibility upon both blood banks and blood establishments to report all serious adverse events and serious adverse reactions to MHRA. Where the handling of such an event or reaction involves both the blood bank and the blood establishment, and in order to avoid duplicate reporting, the two parties should open a dialogue as soon as possible and agree who should take the lead for notification, investigation and confirmation (see flow chart in MHRA guidance document (51Kb)).

A key influencing factor in determining this responsibility will be the identification of which party is best able effectively to investigate the matter, to produce a report and to identify corrective actions.

Whoever takes the lead, a copy of the report may be sent to the other party using the facility on the Report Source section of the SABRE report form.

How do I know if the Reaction or Event is reportable?
Your first reference should be to the MHRA's published 'Background and Guidance on reporting Serious Adverse Events & Serious Adverse Reactions (51Kb)'. If you are still in doubt, e-mail or telephone MHRA or SHOT.

What happens if the Reaction/Event involves anti-D, Octaplas, albumin, IVIg or coagulation factors? Should I use SABRE to report this?
Only SARs and SAEs relating to the quality and safety of blood and blood components are reportable to MHRA via SABRE.

Incidents involving licensed medicinal products (including blood products such as these) may be reportable on the MHRA's Yellow Card system and anti-D and Octaplas also to SHOT (via SABRE).

Should I wait until the investigation of the SAE/SAR is competed, before I submit my report?
No. The legislation requires that you submit a Notification report as soon as the SAE/SAR is observed. Your Confirmation report should then be submitted when you local investigation has been concluded.

I have reported on SABRE and have completed my investigation. Why are you asking me to submit another report?
The legislation requires a two-stage reporting system: a 'Notification' as soon as the incident occurs, followed by a 'Confirmation Report' when you have completed your local investigation and are in a position to confirm whether there actually was a serious adverse event or reaction.

The SABRE system is being set up to despatch automatic e-mail reminders if a Confirmation Report has not been received within a reasonable time.

We have suffered a fridge failure. A unit of blood was transfused before we realised the fridge was not within the correct temperature range. How do we report this?
This should be reported as a serious adverse reaction if the patient suffered a serious reaction, or a serious adverse event if there was no obvious serious reaction in the patient.

For how long I am required to retain records of SAEs and SARs? 
The The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 No. 941(pdf document) confirm that you are required to keep this information for at least 15 years.

Making a report
Why should I allow SHOT to see my SABRE report?
Whilst reporting to SHOT remains voluntary, it is required for compliance with HSC/2002/009 'Better Blood Transfusion' and is a standard for the Clinical Negligence Scheme for Trusts in England. Active participation in SHOT by all hospitals was recommended by the CMO for England in his 2003 Annual Report. A number of blood safety initiatives depend on continuity of SHOT data for monitoring and evaluation and it is therefore vital that hospitals use the SABRE system to continue to report to SHOT.

Has SHOT changed it's reporting criteria or categories?
SHOT's reporting criteria and categories for adverse reactions and incorrect blood component transfused are unchanged. However at present SHOT is not collecting individual reports of 'near-miss' events, pending a review of how best to use this information. For further details of the changes to 'near-miss' reporting please see the SHOT January newsletter.

Will SHOT still be producing an annual report?
Yes, SHOT will continue to analyse questionnaires and produce an Annual Report with recommendations for improving transfusion safety.

The 'Report Source' section of the form asks for a local reference number. What is this?
This can be any number assigned locally to identify a particular report and to distinguish it from any other reports that you may submit. You may find it helpful to use the number assigned by your local risk management or incident reporting system.

I have started to draft a report but now don't wish to submit it. What should I do?
If you have not yet saved or submitted your report, use the 'Discard' button at the top of the SABRE screen.

MHRA intend to introduce a function that will allow you to delete a saved draft (i.e. unsubmitted) report. Submitted reports may not, however, be deleted. Where a mistake has been made, and a report has been submitted in error, please contact the SABRE helpdesk and we will ensure that this is excluded from any MHRA action and statistical analysis.

I have submitted a Notification but now have some additional information. Can I submit this even though I'm not ready to submit a Confirmation?
Additional information can be added to your report as a Footnote. From your Workspace, open the relevant report and click the Footnote button. You may then enter text or attach a file. The presence of a Footnote is indicated by a letter F in the Workspace.

I have submitted a Report Confirmation but have now obtained some additional information. What should I do?
Additional information can be added to your report as a Footnote. From your Workspace, open the relevant report and click the Footnote button. You may then enter text or attach a file. The presence of a Footnote is indicated by a letter F in the Workspace.

How can I let a colleague see a copy of my Report?
Colleagues can see your draft and submitted reports if you engage them as part of your reporting team and provide them with access to a shared SABRE registration. If this is not possible, perhaps for practical or for security and confidentiality reasons, you may send them a copy of a specific report by entering their e-mail address on the Report Source page when completing the form. A copy of the report form will be sent to them when you submit the report.

If you wish, more than one e-mail address may be entered on the form, but multiple addresses must be separated by commas.

When choosing from drop-down lists I am not always sure which option to choose?
The drop-down lists in SABRE are the categories that are required to be reported in the MHRA's annual report to the European Commission. Where possible, please always use the category that best describes what you wish to report. The selection of the category 'Other' should only be used in exceptional circumstances. The SABRE Helpdesk will provide advice where needed.

I have completed my SHOT questionnaire but when I return to it, the content is missing?
Whilst occasional system errors can occur, this is most likely to have happened if you closed the questionnaire window without first saving your work. Please ensure you save or submit your questionnaire before closing the window. Further development of SABRE is ongoing and it is intended to include a warning box reminding you to save your work, if the browser window is closed.

Why am I unable to attach a file to my report?
SABRE has been designed so that a draft report must be saved before a file can be attached.

I have inadvertently included personal patient and/or staff information in my report. How can I remove this?
Contact the MHRA so that we can remove this information.

Remember: personal information should not be included in attachments or footnotes either.

Why do I need to provide the name of a Hospital Consultant on the SABRE form?
This just provides MHRA with a further contact for enquiries. It does not imply the Hospital Consultant's direct involvement with the serious adverse event that occurred, or with the care and treatment of the patient in whom a serious adverse reaction was observed.

Will making a report trigger an inspection by the MHRA?
Reporters have a legal responsibility to report SARs and SAEs and it is an offence not to comply with the regulations. Reports are analyse and data will be sent annually to the EU to comply with the legislation. MHRA will only consider inspecting where there is a serious problem, or a recurrent problem putting patients at risk.

What if the SABRE Helptext and Guidance documents don't give me the answers I need?
Please contact the SABRE Helpdesk in the MHRA Adverse Incident Centre on 020 7084 3336 or by e-mail: sabre@mhra.gsi.gov.uk AIC staff will be happy to answer your questions and provide any additional advice required.

Where there is an evident need for clarification and additional published guidance, MHRA will add to and/or amend the existing Helptext and guidance documents. We will also add to this list of FAQs.

How do I get more hard copies of the Guidance documents?
There are a limited number of hard copy documents available on a first-come first-served basis. Alternatively, you can download them from the MHRA website.

How do I provide feedback on my experience of using SABRE and reporting serious adverse events and reactions?
You can e-mail your feedback direct to the SABRE Helpdesk in the Adverse Incident Centre. We welcome any comments that will help us ensure that you have a full understanding of the legal reporting requirements and are comfortable and confident when using SABRE.

Why did my SABRE session 'time out'?
If you are logged in to SABRE and have not clicked to change page or save your work for two hours, you will automatically be logged out. If this happens you will lose any unsaved data.

This 'time-out' is primarily a security feature that helps avoid unauthorised access to a SABRE account on those occasions when a reporter has, for whatever reason, been distracted from completing their work and has moved away from their PC. Whatever IT system is being used, it is always good practice to ensure that you save your work on a regular basis. Regular saving will help avoid unnecessary loss of work in progress.

Medical device adverse incidents
What is a medical device?
Medical devices and equipment are used for: diagnosis or treatment of disease; monitoring of patients; assistive technology. They include blood bags, syringes, sphygmomanometers, and IV administration sets and pumps.

Blood fridges, blood warmers, plasma thawers, platelet agitators and automated blood groupers are also devices. Other IT systems used may also be medical devices. Please contact the medical devices Adverse Incident Centre on 020 7084 3080 or aic@mhra.gsi.gov.uk if you require assistance.

What should I do if I have a problem with a medical device?
Report it. An adverse incident is any event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of patients, users or other persons. If you observe such an incident involving a medical device, report it to the Adverse Incident Centre.

Where can I find more information about reporting medical device related incidents?
The MHRA publishes comprehensive guidance on reporting medical device related adverse incidents. This is available from the MHRA website.

How do I report and medical device adverse incident?
Reports may be submitted online via the MHRA website on the internet or NHSnet at any time of any day. MHRA strongly recommend that, where possible, online reporting issued

'Paper' forms for reporting incidents may be downloaded from the website and then either completed electronically and e-mails, or printed and sent by mail or fax.

Registration queries
Why haven't I received the confirmation e-mail after registration?
Please allow up to one working day for the registration to be activated. The confirmation e-mail is delivered to the e-mail address supplied on registration and should arrive in your inbox immediately the account is activated. It is therefore important that you check the address carefully before submitting your registration request. If necessary call the SABRE helpdesk (tel: 020 7084 3336) to find our you registration number.

I registered the e-mail address correctly, but I still have not received my confirmation e-mail.
Confirmation e-mails are sent from the address sabre@mhra.gsi.gov.uk. It is possible that your local IT system may identify this as 'spam'. Please liaise with your local IT department to ensure that SABRE e-mails are allowed through. In the interim you can all the SABRE helpdesk (tel: 020 7084 3336) to find out your registration number.

I registered using my personal e-mail address, but we now want to use a generic e-mail address. Do we have to register again?
No. To amend any of the details submitted when you Registered, just log in to SABRE and use the 'Update Registration' option.

Please note that if the change is to your e-mail address, your account will be temporarily suspended whilst we re-verify your details and link your existing reports to the new e-mail address. When this has been completed you account will be re-activated and an automated e-mail sent to the new e-mail address. This is usually completed within one full working day.

If we have more than one person responsible for reporting, must they each have a separate account?
This is your choice. However, we anticipate that many reporters, operating as part of a hospital transfusion team (HTT), will choose to register using a shared e-mail address. This will allow shared access to all your draft and submitted reports and will allow the notification and confirmation of a particular event or reaction to be submitted by different people.

If we use a shared e-mail address how will we know who has actually submitted a particular report?
Whilst the 'Report Source' section of the SABRE Report Form is automatically filled with the registered reporter details, that section is editable. The reporter just needs to enter their own name and contact details.

There is also a question on the SAR and SAE reporting sections asking whether the reporter submitting the confirmation is the same person that submitted the original notification. If you answer No, the form allows the second reporter to enter their own name and contact details.

Log-in and website problems
I have forgotten my registration details. What do I do?
Contact the SABRE helpdesk. Once we have verified your identity we can:

• confirm the e-mail address registered on the system
• re-send your registration number
• re-set your password

NOTE: MHRA does not have access to your password. We can however re-set it in order to re-open your access to SABRE. Once logged in, you should change your password using the 'Update Registration' option within SABRE. This will ensure the confidentiality of your reports.

I'm sure that I'm using the correct registration details, but I still get an error message when I log on?
Ensure that you have used the correct lower and upper case characters when entering your password.

Many reporters access SABRE using the internet 'Favorites' list. On occasion, the Favorites list can hold a corrupt image of the page to be accessed. This can usually be resolved by deleting the Favorite and clearing your internet History folder. Once you have successfully gained access you can save the page as a Favorite again. Check with you IT department if you need help with this.

If the problem persists, contact the SABRE helpdesk.

Why do SABRE pages sometimes open slowly?
This is most likely due to the speed of your local internet connection. Ask you IT department if problems persist.

You may also contact the SABRE helpdesk.