Haemovigilance is the set of procedures aimed at detecting and monitoring serious or unexpected adverse reactions in donors and recipients and of serious incidents inherent to the transfusion process, as well as the surveillance of both transfusion-transmissible infectious diseases and materials and equipment used in the transfusion process (Ministerial Decree of 2nd November 2015).

Haemovigilance systems are governed by specific EU regulatory requirements, transposed by the member states into their national regulations. These regulations define the procedures to be adopted for the reporting of serious undesirable effects observed in patients during and after blood/blood-component transfusion and related to the quality and safety of blood/blood components, including the reporting of any transmission of infectious agents.

Haemovigilance also includes the reporting of serious adverse reactions related to the donation of blood and blood components, i.e. unexpected responses that may result in death, endanger life or produce disability or incapacity in the donor.

Through SISTRA (the Italian Transfusion Services Information System), the aim of the Italian haemovigilance system is to promote the uniformity and comparability of data at national level to facilitate data aggregation and processing, as well as producing national reports that consistently meet the European information deficit.

The haemovigilance macro-area of SISTRA includes notifications related to:

  • donor epidemiological surveillance
  • serious adverse donor reactions
  • serious adverse effects on recipients and transfusion errors
  • major incidents

 

INFORMATION FLOW

Data flow is organised according to levels of competence:

  • The haemovigilance liaison officer in a blood transfusion facility is in charge of collecting reports, both internal and from collection units, and of notifying them to the regional coordination centre via the regional information system if linked to the national system (SISTRA) or, if not, directly via the national system (SISTRA).
  • The regional liaison officer of the coordination centre is in charge of verifying and validating the quality of the information transmitted by the blood transfusion  facilities and forwarding the notifications extracted from the regional information system to the Italian National Blood Centre (CNS).
  • The national liaison officer of the CNS is responsible for the continuous monitoring of the national haemovigilance system through the consultation of single notification forms, and the processing of aggregate data at national level from the notifications validated by the regional coordination centres.

 

Requests for deletion/modification of hemovigilance or epidemiological surveillance notification from SISTRA

Requests for deletion/modification from the “Hemovigilance” Section of SISTRA of a hemovigilance or epidemiological surveillance notification can be sent by the relevant Regional Coordinating Structures for Transfusion Activities (SRCs) to the General Secretariat of the CNS exclusively through the following channels:

In fact, the concerned SRC is responsible for evaluating the request received from the concerned Blood Service and, if it deems it necessary to delete/change the notification from SISTRA, to send a formal request to the CNS.

The request should be accompanied by an explanatory report that always covers the reason for the request and details of the code and type of notification that is the subject of the request.
 
In the case of a request for cancellation/amendment of high severity notifications (Grade 3 and 4), a formal request must also be received and signed by the General Management of the TS’s parent company (accompanied by a detailed report).
 
If the request is not comprehensive, the NSC will send a note to the SRC requesting the necessary additions.
 
Following the evaluation of the request received, the National Blood Center will consider the action to be taken and formally notify the requesting SRC.
 
For clarification and information on using SISTRA functions, a request for assistance can be submitted to the CNS General Secretariat.
 
Instead, for troubleshooting technical problems encountered while using SISTRA, the Ministry of Health Service Desk can be contacted through the following channels: