Changes to UK Haemovigilance MHRA and SHOT reporting

Changes to UK Haemovigilance MHRA and SHOT reporting The MHRA and SHOT are collaborating to improve haemovigilance reporting and to reduce duplication. Phase 1 of an integrated single SHOT and MHRA adverse incident reporting system was introduced in October 2015 A summary of the SABRE online reporting system changes were as follows: The 'SHOT only' and 'Share with SHOT' buttons have been removed The MHRA and SHOT will each review only the cases relevant to their organisation There are more detailed categories in the drop-down box ready to link to SHOT in phase 2 SAR confirmation doesn't need to be done anymore - SHOT will do this and an email will be sent to the reporter SAEs must be confirmed as normal The MHRA and SHOT databases remain separate for now, but with more harmonisation Phase 2 of the integrated system will be introduced in March 2017 A summary of the phase 2 changes are as follows: The ability to add different reporters as well as the main account holder s details The introduction of drop down lists (DDLs) for Incident location and Hospital / Establishment where the incident occurred fields on the Report source page The ability to delete draft reports The addition of tick boxes for the Implicated component field The creation of 3 additional columns on the Workspace for reporter action, MHRA status and SHOT status o Reporter action - informs the reporter of the next expected action to take with the SABRE report o MHRA status - informs the reporter of the current state of MHRA assessment of the SABRE report o SHOT status - informs the reporter of the current state of the SHOT questionnaire and provides a link directly into the SHOT database (Dendrite) Changes made by MHRA on the SABRE HITS (Haemovigilance Incident Tracking System) database will be reflected as changes to the reporter s SABRE report The option to change Notification reports from SAE to SAR or SAR to SAE should they have been incorrectly assigned by the reporter when first reporting the incident Enhanced data transfer from SABRE to SHOT New anti-d immunisation questionnaire on the SHOT database SHOT team shot@nhsbt.nhs.uk or 0161 423 4208 MHRA SABRE helpdesk sabre@mhra.gsi.gov.uk or 020 3080 7336 Page 1

User guide and explanation of the changes made to the SABRE database and the rationale for amendments The purpose of this guide is to inform reporters about the changes that we have made to the MHRA and SHOT reporting systems and what those changes will mean to you. The reporting requirements and definitions for both SHOT and the MHRA have NOT changed, but the functionality of SABRE and communication between SABRE and the SHOT database have been improved. Therefore, please continue to report everything that you would normally report to either organisation through the SABRE online system. A new addition to the system is that reports of anti-d immunisations will now be reported via the combined system rather than through the SHOT website. For more information please see page 11 of this guide. Log on as usual through the SABRE Log In screen. Your user details will remain the same. Page 2

Adding reporters to the main account ***Please log into SABRE as soon as possible after 27 th March to update your account with your list of active users. This list will be used for system-generated e-mails, i.e. reminder and withdrawal e-mails, and for general communication purposes*** From the Workspace click the Manage reporters button To add reporters, click the Add Reporters button Enter the details To use the details of the added reporters, from the Report Source page, click Select reporter and then select the reporter s name. To do this you will have at least to have added the local reference number and selected the report type before you can select the reporter name Page 3

Incident location and Hospital / Establishment where the incident occurred These fields have been altered from free text fields to DDLs. Simply select the locations from the DDLs. The Hospital / Establishment list has been tailored to provide only locations particular to the account being used. Delete draft reports Previous versions of SABRE have not allowed you to delete reports in case one reporter accidentally deleted the wrong report. However, this has often resulted in a number of blank reports which clutter up the Workspace. Phase 2 of the joint project allows you to delete draft reports only on SABRE. To do this, open the report to be deleted and click the delete button. Page 4

Implicated component field There are now tick boxes to add the implicated component to the report instead of the free text field in the SAE form and the DDL in the SAR form. Multiple choices can be selected. Changes to the Workspace Three additional columns have been added to the Workspace and the Footnote column has been removed. These new columns are Reporter action, MHRA Status and SHOT status. Reporter action This column shows the reporter what the next expected action is for the SABRE report. The different actions are: No action Submit Notification Report Confirmation Submit Footnote MHRA Status This column shows the reporter the status of the report on the SABRE HITS database and the expected action from the MHRA Haemovigilance team. The different statuses are: Not received Confirmation required Pending MHRA review Excluded Closed Page 5

SHOT Status This column shows the reporter the status of the corresponding report on the SHOT Database (Dendrite). Also, this column provides a link directly to the SHOT Database without the need for a separate log-in. The link to the SHOT database will not be instantaneous, but should be generated within a few minutes of submitting the SABRE notification. You may need to refresh the screen (press F5 ) if the link does not appear automatically. There are two choices, Open (or any other status) for a link via the general internet or N-3 for those reporters who require an N3 connection. The different statuses are: Open: The SHOT report is open and requires completion by the reporter Closed: The SHOT report has been completed and closed by the reporter Withdrawn: The SHOT report has been reviewed and withdrawn by the SHOT Team It is hoped that the addition of these columns will give each reporter more feedback from MHRA and SHOT with regard to the assessment of each report and the expected next steps without having to keep records of Excluded reports, Outstanding Confirmations and records of additional Footnotes required. 1 2 3 5 4 6 1. Indicates a draft SAE Notification report which requires submission as MHRA and SHOT have not received the report 2. Indicates that a Footnote has been requested 3. Indicates that MHRA has closed the report 4. Indicates MHRA has excluded the report 5. Indicates an SAE where Confirmation is required on SABRE and action required by the reporter and an SAR where Confirmation is required by SHOT, but no action is required by the reporter on SABRE 6. Indicates the status of the SHOT report and the web link or N3 link to access the SHOT database directly. Page 6

Changes made by MHRA to SABRE reports Once a reporter has submitted a SABRE report, the MHRA will sometimes amend categories and data within those reports on the MHRA SABRE HITS database. Previously, these changes were not reflected on SABRE and MHRA notified reporters by email about changes made that would be reflected in the next Annual Summary Report. Now, when changes are made following assessment by the MHRA haemovigilance team, or additional information from the reporter or SHOT, these changes will be reflected in your report. Reporters will still receive notification emails from MHRA and you will still have the opportunity to discuss any changes made. SAE Event category One of the changes to a report often concerns the Event involving category. Reporters must continue to select the BSQR or SHOT category as before. However, should a report be in the Other category, MHRA will change that category to reflect the chosen sub-category applied by MHRA and assessed in the yearly SHOT reports. It is hoped that this will give each reporter a clearer idea of the types of SAE raised at each hospital. This change will be reflected in the SAE report. E.g. This report has been correctly reported as Other/ IBCT SRNM, but incorrectly classed as Equipment failure. Page 7

On receipt of the Confirmation report, MHRA will change the categories to reflect the MHRA subcategory for the event and to correct the Specification category. Amending Report Types If a reporter incorrectly reports an SAE instead of an SAR, or vice versa, currently the reporter is required to report the incident again in the correct format, while the original report is excluded. New functionality will allow MHRA to change the Report type of Notification reports only. Once this has been done, the reporter is required to then re-submit the amended form. In the image below, 2017/003/001/HV1/164 has been submitted as an SAE. If this is incorrect, contact MHRA or MHRA will contact you to arrange the change of report type. Once MHRA have made the change, your report will appear in the Workspace as below. The Report type has now changed from a submitted SAE Notification report to a draft SAR with the original MHRA reference number. You are required to complete the new form and submit as usual. Page 8

Changes to the SHOT Database (Dendrite) Completing a report on the SHOT database will be largely unchanged; however there are some improvements and additions in the following areas: SHOT Database user accounts Enhanced data transfer between SABRE and SHOT Anti-D immunisation reporting Transfusion-transmitted infection questionnaire Outcome and Procedural review pages Exiting the SHOT database and returning to SABRE SHOT Database User Accounts The SHOT database is now accessed only via the links on the SABRE workspace, so there is no need to maintain a user account for the SHOT database, or to log in directly. All access is controlled via the SABRE account. Automated e-mails from SHOT, for example, the reminder e-mails, and withdrawal e-mails will continue to be sent. These e-mails will be received by all reporters associated with the SABRE account that have been entered in the Manage reporters section described above. Enhancements to the transfer of data between SABRE and the SHOT database Improved links between the two systems means that as much of the data populated on SABRE as possible are now transferred across to the SHOT database, to avoid duplication. The extra fields on SABRE that will now transfer across to the SHOT database are: Report Source page: Incident location Hospital / Establishment where incident took place Serious Adverse Event page: Implicated component Blood component transfused Root cause analysis (outcome of investigation) Corrective measures taken (details) Serious Adverse Reaction page: Date of transfusion Adverse reaction related to Page 9

In most cases, the SHOT report category will be pre-populated based on the type of report entered on SABRE. For example an SAE reported on SABRE as Other / IBCT-WCT will be accepted into the SHOT database as an IBCT wrong component transfused, as long as the new field on SABRE Blood component transfused is answered Yes. If this question is answered No, then the category on the SHOT database would be set as Near Miss. For example an SAR reported on SABRE as Other / Febrile ATR will be accepted into the SHOT database as an Acute transfusion reaction. Any attachments added to the SABRE system will be copied across to the SHOT database and appear on a new page called Footnotes. This new page will only exist if an attachment has been uploaded to SABRE. When an SAE report is confirmed on SABRE, the 2 fields, Root cause analysis (outcome of investigation) and Corrective measures taken (details) will transfer across to the associated SHOT questionnaire on the Procedural review page. These 2 new fields on the SHOT database are read only, and will only be populated via SABRE. For those reports that are not MHRA reportable and have been excluded on SABRE, and therefore do not require the SAE report to be confirmed, any details of the root cause or CAPA can be added to the other free text fields on that page. Reporters are reminded that it is important to complete these fields in the SHOT database. Page 10

Anti-D Immunisation Reporting Anti-D immunisations will now be reported on the SHOT database rather than the previous Wordbased questionnaire located on the SHOT website. Any anti-d immunisations should be reported via SABRE as an SAE by selecting Other / Anti-D immunisation for Event involving. Once on the SHOT database, there is a new set of questionnaire pages to complete for the details relating to the anti-d immunisation. TTI questionnaire Outcome and Procedural review pages The standard Outcome and Procedural review pages, which apply to all other relevant SHOT categories have been added to the TTI questionnaire. This is to ensure that all the required detail can be entered on to the SHOT database in order for SHOT to complete the SAR confirmation report on SABRE. Page 11

Exiting the SHOT Database Clicking Save and Exit from within a SHOT questionnaire will return the user to the main SHOT workspace, where all other historic SHOT reports for that reporting organisation can be accessed. The SHOT Database should always be closed by clicking the Exit Application button at the bottom left-hand side of the screen. Once this button is clicked, the user will be taken to a page where there is an option to return to the SABRE workspace. To return directly to the SABRE workspace, the link shown below can be clicked. Alternatively the browser can be closed if there are no further actions needed. Page 12