Action 7.7 states

The health service organisation uses processes for reporting transfusion-related adverse events, in accordance with national guidelines and criteria

Intent

Transfusion-related adverse events are reported to enable identification of previous adverse reactions or special transfusion requirements, and to drive improvement opportunities.

Reflective questions

How are blood management incidents reported and managed?

To whom does the health service organisation report adverse reactions to blood and blood products?

Key tasks

  • Capture blood-related incidents in incident management and investigation systems, and provide reports from these systems to the blood management governance group to inform activities in the blood management quality improvement system (see Action 7.2)
  • Provide a summary analysis of blood- and blood product–related incidents to the highest level of governance in the organisation for review and action
  • Report transfusion adverse events in accordance with regulator and supplier requirements, as well as local policies and procedures
  • Develop and implement education activities for reporting transfusion-related adverse events in accordance with national guidelines and criteria.

Strategies for improvement

Hospitals

An adverse event, adverse reaction or near miss is an incident where the patient experienced actual or potential harm. Adverse reactions, adverse events and near misses relating to blood and blood products often go unrecognised and unreported.1, 2

Capture transfusion-related incidents, including near misses, in the organisation’s incident management and investigation systems under a category for incidents relating to blood and blood products. (Do not include incidents relating to blood spills or blood collection that are unrelated to transfusion.) Routinely report this information to the blood management governance group (refer to Action 7.2) for analysis. This analysis will feed into the assessment of risks (as described at Action 7.1) and implementation of risk mitigation strategies (as described at Action 7.2).

Align local incident reporting with state and national haemovigilance requirements, including classification of incidents.

Provide a high-level summary and analysis of the incidents to the highest level of governance for review.

Report adverse events to the pathology service provider, the Australian Red Cross Blood Service or product manufacturer, and the Therapeutic Goods Administration (TGA; if required). Reporting adverse transfusion events allows identification of other patients at risk because of patient identity error (for example, ABO-incompatible transfusion to a second patient) or because other blood components collected from the implicated donor may also be affected (for example, in cases of bacterially contaminated blood components3), and assists in monitoring safety and quality of a product (for example, allergic reactions). The Blood Component Information booklet4 describes adverse reactions, and identifies which reactions must be reported to the Australian Red Cross Blood Service. For commercial products, check with the manufacturer to identify their adverse event reporting requirements. Links to suppliers are on the NBA website.

Report adverse events internally to the appropriate governance level of the organisation. Given the complexity and multifaceted reporting requirements for transfusion-related adverse events, ensure that there is a policy, procedure or protocol in place that identifies the classes of transfusion-related adverse events that must be externally reported, including the time frame for reporting.

All members of the workforce involved in transfusion of blood and blood products are expected to receive orientation or training for reporting transfusion-related adverse events in accordance with national guidelines and criteria.

Day Procedure Services

Applicability of actions

The actions in the Blood Management Standard will not be applicable for day procedure services that do not use blood or blood products. These services should provide evidence that they do not use, receive, store, collect or transport the blood or blood products governed under this standard.

Services using blood or blood products should refer to the information provided for hospitals for blood management.

MPS & Small Hospitals

MPSs and small hospitals may need to:

  • Capture blood-related incidents in the incident management and investigation systems, and provide reports from these systems to the blood management governance group to inform activities in the blood management quality improvement system (see Action 7.2)
  • Provide a summary analysis of blood- and blood product–related incidents to the highest level of governance in the organisation for review and action
  • Report transfusion adverse events in accordance with regulator and supplier requirements, as well as local policies and procedures
  • Develop and implement education activities for reporting transfusion-related adverse events in accordance with national guidelines and criteria.

Hospitals

An adverse event, adverse reaction or near miss is an incident where the patient experienced actual or potential harm. Adverse reactions, adverse events and near misses relating to blood and blood products often go unrecognised and unreported.1, 2

Capture transfusion-related incidents, including near misses, in the organisation’s incident management and investigation systems under a category for incidents relating to blood and blood products. (Do not include incidents relating to blood spills or blood collection that are unrelated to transfusion.) Routinely report this information to the blood management governance group (refer to Action 7.2) for analysis. This analysis will feed into the assessment of risks (as described at Action 7.1) and implementation of risk mitigation strategies (as described at Action 7.2).

Align local incident reporting with state and national haemovigilance requirements, including classification of incidents.

Provide a high-level summary and analysis of the incidents to the highest level of governance for review.

Report adverse events to the pathology service provider, the Australian Red Cross Blood Service or product manufacturer, and the Therapeutic Goods Administration (TGA; if required). Reporting adverse transfusion events allows identification of other patients at risk because of patient identity error (for example, ABO-incompatible transfusion to a second patient) or because other blood components collected from the implicated donor may also be affected (for example, in cases of bacterially contaminated blood components3), and assists in monitoring safety and quality of a product (for example, allergic reactions). The Blood Component Information booklet4 describes adverse reactions, and identifies which reactions must be reported to the Australian Red Cross Blood Service. For commercial products, check with the manufacturer to identify their adverse event reporting requirements. Links to suppliers are on the NBA website.

Report adverse events internally to the appropriate governance level of the organisation. Given the complexity and multifaceted reporting requirements for transfusion-related adverse events, ensure that there is a policy, procedure or protocol in place that identifies the classes of transfusion-related adverse events that must be externally reported, including the time frame for reporting.

All members of the workforce involved in transfusion of blood and blood products are expected to receive orientation or training for reporting transfusion-related adverse events in accordance with national guidelines and criteria.

Day Procedure Services

Applicability of actions

The actions in the Blood Management Standard will not be applicable for day procedure services that do not use blood or blood products. These services should provide evidence that they do not use, receive, store, collect or transport the blood or blood products governed under this standard.

Services using blood or blood products should refer to the information provided for hospitals for blood management.

MPS & Small Hospitals

MPSs and small hospitals may need to:

  • Capture blood-related incidents in the incident management and investigation systems, and provide reports from these systems to the blood management governance group to inform activities in the blood management quality improvement system (see Action 7.2)
  • Provide a summary analysis of blood- and blood product–related incidents to the highest level of governance in the organisation for review and action
  • Report transfusion adverse events in accordance with regulator and supplier requirements, as well as local policies and procedures
  • Develop and implement education activities for reporting transfusion-related adverse events in accordance with national guidelines and criteria.

References

  1. National Blood Authority Haemovigilance Advisory Committee. The Australian haemovigilance report. Canberra: National Blood Authority; 2010.
  2. National Blood Authority Haemovigilance Project Working Group. Initial Australian haemovigilance report 2008. Canberra: National Blood Authority; 2008.
  3. Australian and New Zealand Society of Blood Transfusion, Royal College of Nursing Australia. Guidelines for the administration of blood products 2nd ed. Sydney: ANZSBT; 2011.
  4. Australian Red Cross Blood Service. Blood component information: an extension of blood component labels. Melbourne: ARCBS; 2015 (accessed Sep 2017).