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Reporting to the National Haemovigilance Office

Rapid Alert Notification

This is the immediate urgent notification to the supplying Blood Establishment or Blood Bank to initiate a recall of blood components or to prevent the issue of blood components.

The aim of Rapid Alert is to protect the blood supply and any potential recipients.

The system should be activated in the following circumstances

  • Suspected bacterial infection
  • Viral, parasitic or other post transfusion infection
  • Transfusion Related Acute Lung Injury (TRALI)
  • Failure in blood processing/equipment in blood establishments e.g. failure of irradiation

Where there is a suspected Transfusion Transmitted Infection or a suspected Transfusion Related Acute Lung Injury careful clinical assessment of the patient should take place.

A decision to initiate a rapid alert should be taken following review with a consultant haematologist or the patient's primary physician. This decision should be taken at hospital level.

If a hospital consultant is unavailable or if further assistance is needed an IBTS consultant may be contacted (via switch board 01 4322800 /021 4807400) The aim of Rapid Alert is to protect the blood supply and any potential recipients.

How to Report?

  • Telephone contact to the National Haemovigilance Office at 01 4322891/25
  • Quality Assurance Department of the IBTS - 01 4322800 (Dublin), 021 4807400 (Cork)
  • Through a Consultant Haematologist or Medical Officer in the IBTS 01 4322800 (Dublin) 021 4807400 (Cork)
  • Through Medical Scientist on duty at the IBTS at 01 4322800 (Dublin) 021 4807400 (Cork) - outside of office hours

 

Reporting of Serious Adverse Reactions/Serious Adverse Events

Since 1999, the NHO has collated data relating to serious adverse reactions and events associated with blood and blood components and SD Plasma, as well as serious adverse events associated with some blood-derived medicinal products. While this remit is broader than that mandated by EU and National legislation, the NHO will to continue to capture these adverse reactions and events.

However reporting of Serious Adverse Reactions (SAR) which may be attributed to the quality and safety of blood components and Serious Adverse Events (SAE) relating to collection testing processing storage and distribution of blood and blood components are mandatory.

The NHO, in collaboration with the Irish Medicines Board has published a guide on reporting titled:

Requirements forHospital Blood Banks for Reporting Serious Adverse Reactions and Events to the National Haemovigilance Office.

 A working document is available at this time to assist hospital based haemovigilance staff in the reporting of serious adverse reactions and events to the NHO.

Please contact the NHO for a copy of the working document - haemovigilance@ibts.ie


How to Report?

Initial Report forms are now available here.(Version 4)

Guidance for the completion of the report form is contained within the Haemovigilance Handbook

Contact 01 4322825/01 4322741 or haemovigilance@ibts.ie

Reporting Delayed Serological Transfusion Reactions

Delayed Serological Transfusion Reactions are no longer reportable to the NHO since Jan 2016.

If you require further information please contact the office haemovigilance@ibts.ie

 

Near Miss Reporting for Hospitals

The working party on behalf of the European Commission examining reportable serious adverse events and reactions under Directive 2005/61/EC has made the following recommendation.  From beginning of 2010, it will be mandatory to report all near miss events occurring in the Hospital Blood Bank  (HBB).   In Ireland these will be reported to the National Haemovigilance Office (NHO).  The NHO will submit these reports as serious adverse events (SAE) to the Health Products Regulatory Authority (HPRA), who in turn submits an annual report to the European Commission.

How to Report?

Hospital Blood Bank Near Miss Notification Report Form V2

Hospital Blood Bank Near Miss Confirmation Report Form V2

Guidance on completion of the report forms is contained in the Haemovigilance Handbook: Requirements forHospital Blood Banks for Reporting Serious Adverse Reactions and Events to the National Haemovigilance Office.

Please contact the NHO for a copy of the working document - haemovigilance@ibts.ie

Near Miss Reporting for Blood Establishments

(Applicable only to University Hospital Galway and First Direct Medical Couriers)

From beginning of 2010, in conjunction with the reporting of serious adverse events  it will be mandatory to report all near miss events occurring in the Blood Establishment(BE). In Ireland these will be reported to the National Haemovigilance Office (NHO).The NHO will submit these reports as serious adverse events (SAE) to the Health Products Regulatory Authority (HPRA), who in turn submits an annual report to the European Commission.

How to report ?

These forms are only applicable to University Hospital Galway and First Direct Medical Couriers

Blood Establishment SAE/Near Miss notification report form

Blood Establishment SAE/Near Miss confirmation report form.

If you have any queries on reporting SAE/Near Miss events from either the Hospital Blood Bank or from a Blood Establishment you can contact us at haemovigilance@ibts.ie or by telephone at 01 4322825 / 01 4322891

Annual Notification for Serious Adverse Reactions and Events (ANSAR/E) to the Competent Authority (Irish Medicines Board)

Commission Directive 2005/61/EC Articles 6 and 8 direct that blood establishments and hospital blood banks submit an annual report of serious adverse events and reactions to the Commission of the European Communities.
The NHO collates these reports and submits them on behalf of reporting establishments to the competent authority (HRPA) by the 30th April of the following year.

How to Report?

  • The NHO issue the ANSAR/E form to all reporting establishments at the end of January each year.
  • Only mandatory reports are included on the ANSAR/E form.
  • Completed forms must be returned to the NHO by a specified date

 

National Blood Centre, James's Street, Dublin 8.       Tel: 00 353 1 4322800       Fax: 00 353 1 4322930