How we monitor the safety of tissues and cells

We are the competent authority (CA) responsible for implementing human tissues and cells legislation.

We have established a reporting system for suspected Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with human tissues and cells. 

All Tissue Establishments must report any events which meet the definitions below.

A 'serious adverse event' is defined as any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity.

A 'serious adverse reaction'  is defined as an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity;  

Reportable events in Assisted Reproductive Technology include: Any type of gamete or embryo misidentification or mix-up; transmission of a genetic disease to an offspring following the use of non-partner gametes; moderate or severe OHSS in the woman; accidental loss or contamination of embryos. This list is not exhaustive, see our Guide to Reporting Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with Human Tissues and Cells for further information.

Note: In the case of assisted reproduction:

• Any type of gamete or embryo misidentification or mix-up, are considered a serious adverse event.
• 'Near miss' reports where the event was detected prior to transplantation are considered reportable.

How to Report

The initial report should be submitted to the HPRA without delay in one of the following ways:

• By using our online form.
• By downloading and emailing a copy of the reporting form below.

Further updates should follow with information on the root cause investigations, outcomes and corrective actions taken.

Additional guidance on reporting incidents, and near miss events is available in our guidance document linked below.