Reporting undesirable effects of transfusion (haemovigilance)
Haemotherapy often plays a crucial role in the medical treatment of patients and has contributed to medical progress. However, despite all the safety measures in the manufacture, testing and administration of blood and blood components, the occurrence of undesirable effects cannot be ruled out. The collection and evaluation of data on transfusion reactions and quality defects enables us to detect transfusion risks and develop recommendations to optimise haemotherapy.
Definition:
Set of surveillance procedures that cover the whole transfusion chain and detect and analyse unexpected or undesirable events before, during or after the administration of blood components, with the aim of preventing their occurrence or recurrence.
The purpose of haemovigilance is to improve the safety of transfusion therapy.
The procedures are based on the reporting of any incidents, events and transfusion reactions that occur anywhere in the chain from the donor selection to the administration of blood products to the patient. Analysing the haemovigilance reports provides a picture of current transfusion risks, and may provide information about the causes of preventable transfusion events and show where improvements are necessary and possible.
In accordance with Article 58 of the Swiss Law on Therapeutic Products, Swissmedic is responsible for haemovigilance.
Any institution authorised to handle blood and blood products (e.g. blood transfusion services) must have a reporting procedure and appoint a person who is in charge of haemovigilance and reports adverse incidents that occurred during the production and distribution of the products (AMBV Art.16, VAM Art.35 & 39).
Institutions where blood components are administered (hospitals) are obliged to set up a state-of-the-art quality system, to report any unexpected or undesirable events related to a blood transfusion, and to appoint a person who is responsible for fulfilling any reporting duties (haemovigilance officer HO). Art. 39, par. 4 VAM) (-> Link)
Reports of undesireable or unexpected transfusion reactions are forwarded by the haemovigilance officer to the Haemovigilance Unit at Swissmedic.
If there is any suspicion of a quality defect of a transfused blood product, the blood transfusion service concerned must be advised. If any other blood products might be affected, the blood transfusion service must be informed immediately, so that these products can be held back or recalled without delay (e.g. if bacterial contamination of the blood product is suspected).
Swissmedic is in contact with other national and international authorities, various professional societies and expert groups, and the SRC Blood Transfusion Service (BTS).
A no-blame culture is crucial to a well-functioning haemovigilance system. Consequently, reports to the Swissmedic Haemovigilance Unit do not give rise to any legal actions.
* FOPH = Federal office of Public Health ** SRC BTS = Swiss Red Cross Blood Transfusion Service ***SVTM/ASMT = Swiss Association ofTransfusion Medicine
Infections (viral, bacterial, parasitic or prions)
All infections transmitted by blood components must be reported.
N.B. The Law on Epidemics dated 18 December 1970 and the Ordinance on Reporting Communicable Diseases dated 13 January 1999 remain unchanged (obligation to report cases of AIDS and hepatitis, positive results of related infection marker tests to the Epidemiology Department of the Federal Office for Public Health).
Other notifiable incidents in connection with transfusions Transfusion errors (IBPT - incorrect blood product transfused)
This refers to all blood products that have been incorrectly transfused, regardless of whether an adverse effect occurred in the patient or not. This category includes: blood products that were intended for another patient or blood products that were not suitable for that particular patient (e.g. not irradiated, not CMV negative, etc.), but also transfusions of homologous blood products when autologous blood products were available.
Near-miss incidents (pretransfusion errors discovered in time)
Any deviation that was discovered before the transfusion was carried out, e.g. irregularities in patient identification, test tube labelling, or the prescription of blood products).
Notifiable incidents in blood product manufacture
Safety risks for blood donors: incidents that endanger the health of the blood donor.
Mix-up of donors and donated blood.
incorrect labelling, incorrect release
Release of blood products that do not correspond to specifications
Defective materials or reagents. Incorrect testing
Suspected quality defect
Detection of a transfusion-transmissible infection in a blood donor
Reports must be filed by any professionals who administerblood components. As a general rule the doctor in charge of the transfusion and nursing or laboratory staff report the transfusion reaction (TR) to the local hémovigilance officer, who forwards the report to Swissmedic once the clinical and diagnostic tests have been carried out.
Incidents can be reported using the special report forms that are available on the Swissmedic haemovigilance website. There are separate reporting forms available for transfusion reactions and transfusion errors / near miss events.
In order to ensure that the evaluations lead to significant conclusions, the haemovigilance report form should be filled in as completely as possible and contain all relevant clinical data and laboratory results. If, at the time the report is filed, any analysis results are still outstanding, please forward them to Swissmedic in due course. In the event of further questions it is important to provide contact details of the haemovigilance officer and the institution where the transfusion reaction occurred.
The report forms are available in German, French and Italian.
All reports received are logged and an acknowledgement of receipt is sent to the sender. All incoming reports are logged electronically, reviewed and analysed by the clinical reviewers for haemovigilance at Swissmedic. If necessary the reporting haemovigilance officer is asked for further details. Should it emerge from the analysis of individual cases or the annual statistics that specific actions need to be taken, e.g. the introduction of corrective measures, appropriate recommendations are made in collaboration with the institutions involved.
The data are published each year in an annual haemovigilance report.
Les données sont publiées chaque année dans un rapport sur l'hémovigilance.
