4.3 Some features of different national haemovigilance programmes

Established national haemovigilance programmes have developed somewhat different definitions and reporting requirements such as the examples that follow.

The Netherlands’ Haemovigilance Organization (TRIP), uses the term:

Serious Transfusion Reaction – any incident that results in death or is life threatening to a patient, or that requires hospitalisation or prolongs hospital stay or that results in persistent significant disability. www.shotuk.org

A number of schemes including the UK scheme, SHOT use the term:

Near miss – an error that might have harmed a patient but did not

National haemovigilance schemes do not all collect the same level of information, for example,

the Netherlands’ scheme requires hospitals to report all incidences of transfusion of an incorrect blood component, but regards reporting of near misses as optional
UK and Ireland concentrate on ‘serious hazards’ of transfusion, which are defined in their reporting schemes but do not accept reports of transfusion reactions that, although more common are considered to be less serious such as febrile non haemolytic reactions
in France haemovigilance data is collected on all reactions regardless of severity www.ints.fr

These differences make it important to exercise care when comparing results among the different schemes. This is illustrated by the data from four national Haemovigilance schemes shown in Table 4.3, which shows very different rates of events, due in part to the different reporting requirements.

Table 4.4 Preventable and non preventable adverse events

Type of adverse reaction	Related to the quality and safety of the supplied blood component?	Related to failure in clinical transfusion process?	Means of prevention

Transfusion - transmitted bacterial infection	Yes	Possible due to failure to inspect component before transfusion	Donor skin cleansing Diversion pouch on donation line Pathogen reduction Correct storage conditions
Transfusion-transmitted viral infection HBV HCV HIV-1/2 Other	Yes	No	Correct handling to avoid damage to containers Donor selection Donation testing Pathogen reduction
Transfusion-transmitted parasitic infection Malaria Other	Yes	No	Donor selection Donation testing Pathogen reduction
Haemolysis due to incorrect storage	No	Yes	Quality assured clinical transfusion process
Immunological haemolysis due to ABO incompatibility	No	Yes
Immunological haemolysis due to other alloantibody	No	Yes
Anaphylaxis or hypersensitivity Posttransfusion purpura Transfusion-related acute lung injury	No	No	May be unpredictable and unavoidable TRALI risk may be reduced with FFP from male donors
Graft versus host disease	No	Yes Due to failure to select component or failure to recognise patient at risk	Use of irradiated components for at-risk patients Use of amotosalen treated platelets
Transfusion associated circulatory overload	No	Yes Due to failure to recognise patient at risk	Avoid over-infusion.

Figure 4.1 Types of adverse events and reactions. Serious hazards of transfusion (SHOT) UK.

www.shot.org.uk

Cumulative numbers of cases reviewed 1996-2008 n=5374
*New categories for 2008
Figure 4.1

Table 4.3 Adverse events and reactions: reported rates in different countries

International Comparison

Country	Status	Captures	Reports/1000 units
France (2005)	Mandatory	all	2.8
UK (2005)	Voluntary	serious	0.20
Ireland (2005)	Voluntary	serious	1.22
Netherlands (2006)	Voluntary	all	2.9

Risk management involves recording information on when errors were made, whether they were detected and how they were detected, and the reason for the error. This is sometimes called “root cause analysis”. Figures 4.2 and 4.3 show how one scheme has used its data to map the site of the first error the step in the clinical transfusion process where it occurred. In this example, the large number of incidents reported and categorised as ‘pretransfusion testing’ is mainly due to errors in collecting the pretransfusion sample rather than to errors in the blood bank laboratory. Nearly all these reports are of near misses. The corrective measure adopted in this case was to require that the blood group is always determined on two independent samples before compatible blood is issued.

Figure 4.2 Where adverse events and reactions occur in the clinical transfusion process: Netherlands haemovigilance scheme (TRIP)

Figure 4.2

Figure 4.3 Site of first error leading to potential ABO incompatibility incident Netherlands haemovigilance scheme (TRIP)

Figure 4.3