Reporting to the National Haemovigilance Office

Quick Reporting Form Links:

More detail on each required form below. 

Rapid Alert Notification

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

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

Reporting of Transfused Events - Serious Adverse Reactions/Serious Adverse Events

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

Serious Adverse Event/Near Miss Event Mandatory:  Definition

Any untoward occurrence associated with the collecting, testing, processing, storage and distribution of blood and blood components that might:

  • Lead to death
  • Be life-threatening
  • Cause disabling or incapacitating conditions
  • Result in, or prolong, hospitalisation or morbidity

 

Serious Adverse Reaction:  Definition

An unintended response in the patient associated with the collection or transfusion of blood and blood component that:

  • Is fatal
  • Is life-threatening
  • Causes disabling or incapacitating conditions for patients
  • Results in, or prolongs, hospitalisation or morbidity

 

The NHO, in collaboration with the Health Products Regulatory Authority (HPRA), has published a guide on reporting titled:

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

Please contact the NHO office directly for this guide. 

Near Miss events

Complete relevant reporting forms:

Hospital Blood Bank SAE Near Miss Notification Report Form.pdf (size 19.4 KB)

Hospital-Blood-Bank-SAE-near-miss-confirmation-Report-Form.pdf

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.

Wrong Blood in Tube (WBIT) Clinical Near Miss Events

Complete relevant reporting form Wrong Blood in tube (Clinical Near Miss) Report Form.

Following on from a national audit in 2018, the National Haemovigilance Office (NHO) has commenced the collection of Wrong Blood in Tube (WBIT) clinical near miss events from March 4th 2019.

National Haemovigilance Office Guidance Document on Reporting Wrong Blood in Tube.pdf (size 603.2 KB).

Please note that if the patient has been transfused and a Wrong Blood in tube (WBIT) event has occurred we ask that you report the event in the usual manner on our IRF initial report form –  BT 404.

Annual Notification for Serious Adverse Reactions and Events (ANSAR/E) to the Competent Authority (Health Products Regulatory Authority)

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) on an agreed date.

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

NHO Contact Information

If you have any queries please contact 01 432 2825/01 432 2741 or haemovigilance@ibts.ie.