For many years, haemovigilance systems worldwide have mainly focused their resources on the identification and classification of undesirable reactions attributable to the intrinsic biological characteristics of blood components in order to establish targeted actions for corrective or preventive measures, including those at national level. Today, in developed countries, blood components have achieved a high degree of quality and safety, the risk of transmission of viral agents is the lowest currently achievable and specific measures for the prevention of transfusion related acute lung injuries (TRALI) have been developed and adopted in many countries. However, blood transfusion is still the cause of serious adverse reactions and fatal events, mainly caused by errors in the process of transfusion allocation, delivery and administration.

According to the Food and Drug Administration (FDA) report on transfusion deaths in 2011, haemolytic transfusion reactions due to ABO incompatibility have increased, although the trend from 2001 to 2011 appears to have been steadily downward. The SHOT haemovigilance report for the year 2011 shows an overall improvement in transfusion safety, but confirms numerous transfusion errors in the Incorrect Blood Component Transfused category.

In Italy, the Ministry of Health has defined a list of sentinel events in health care activities, for which mandatory reporting is established. La reazione trasfusionale per somministrazione di trasfusione ABO incompatibile rientra tra gli eventi sentinella con obbligo di segnalazione (cfr. Attached file 3, Racc. N. 5 agg. del 2020).

Italian haemovigilance figures have shown a growing participation of blood transfusion services with a progressive increase in reporting, a sign of constant improvement in reporting and of operator compliance.

The most frequently reported side effects between 2009 and 2020 were non-haemolytic allergic and febrile reactions, accounting for more than 70% of the total. Among the most serious adverse reactions, AB0 incompatibility reactions accounted for 7%, all due to errors in patient identification or the use of blood not intended for the patient.

This evidence dictates the need to introduce tools that can be used to prevent human error as a potential cause of ABO incompatibility transfusion reactions. The following aspects are of particular importance:

Training of healthcare professionals

  • Training programme: The Italian National Blood Centre (CNS) is engaged in organising training events addressed to the main actors of the blood transfusion system (Regional Coordination Centres, scientific societies, health management, and representatives of the College of Professional Nurses).
  • Adoption of standardised operating procedures, disseminated to all personnel involved, for the correct identification of the patient (e.g. the UK experience emphasises that only specifically trained and regularly updated personnel should administer a blood component, see UK BTS website). The CNS has published ten simple rules for the prevention of blood group incompatibility (ABO) transfusion reactions (see Annex 1) and has recommended that a record of the control steps prior to the administration of blood or a blood component be compiled and signed by two different operators, and kept in the patient’s medical record (see Annex 2).

2. Patient information

The experience of the United Kingdom (see Annex 3) and the Clinical Risk Management Centre of the Region of Tuscany in Italy (see Annex 4), are given as examples of patient information.

3. The use of technology through barrier tools.

Attached:

  1. Decalogue for the prevention of blood group incompatibility (ABO) transfusion reaction from the National Blood Center.
  2. ABO Error Prevention Check-List
  3. Recommendation No. 5, Year 2020 Update of the Ministry of Health: ‘Recommendation for the prevention of AB0 incompatibility transfusion reaction’.
  4. Flyer produced by NHS Blood and Transplant as part of the 2012 Transfusion Awareness Campaign. More information about the UK experience is available on the UK BTS National Blood Transfusion Services website
  5. “Aida or Lidia” campaign materials from the Tuscany Region Clinical Risk Management Center: poster, flyer and bookmark.