Hemovigilance is an essential system that aims to guarantee transfusion safety throughout the process, from blood collection to transfusion in the patient. It is based on the monitoring and evaluation of adverse effects that may occur during the therapeutic use of labile blood products (LBP), such as red blood cell concentrates, platelets, or plasma.
This complex transfusion chain, which runs from donors to healthcare facilities, relies on a strict system of screening, quality control of blood products, and risk management. Hemovigilance plays a key role in identifying, reporting, and preventing adverse effects related to transfusions. It is coordinated nationally by organizations such as the National Agency for Medicines and Health Products Safety (ANSM) and the French Blood Establishment (EFS).
This comprehensive guide is designed for healthcare professionals wishing to better understand and master this system, guaranteeing the health and safety of both recipients and donors.
What is hemovigilance?
Definition and objectives
Hemovigilance is an organized monitoring system that covers the entire transfusion chain, from blood collection to the follow-up of recipient patients. Its main objective is to prevent, detect, report, and analyze any adverse effect or incident related to the use of labile blood products. It aims to ensure transfusion safety by guaranteeing the quality and reliability of the products, while protecting the health of recipients and donors.
Through this system, hemovigilance enables continuous monitoring of adverse effects that may occur during blood transfusions. It also plays a key role in implementing corrective measures to reduce the risks associated with transfusion.
History and importance of hemovigilance
Hemovigilance emerged in the 1990s in response to serious transfusion incidents and health crises related to blood safety, particularly the transmission of infectious diseases. In France and elsewhere, this system has become an essential pillar in the monitoring and evaluation of adverse transfusion effects. It relies on the collaboration of institutional actors such as the National Agency for Medicines and Health Products Safety (ANSM) and the French Blood Establishment (EFS).
Its development has considerably enhanced safety and confidence in the use of blood products. It has also enabled the introduction of advanced screening and traceability practices, thanks to the rigorous management of labile blood products (LBS).
This system is now essential to guarantee public health. It ensures constant vigilance against the risks associated with blood components and their therapeutic use.
The actors of hemovigilance
Roles and responsibilities within healthcare facilities
At the heart of the organization of hemovigilance in hospitals, several actors play specific and complementary roles. The hemovigilance correspondent, designated in each public or private hospital, is responsible for collecting and reporting any adverse effects occurring in a recipient of labile blood products, as well as any serious incident related to the transfusion chain. They manage the investigations and ensure compliance with procedures regarding hemovigilance.
Healthcare professionals play an active role in promptly reporting incidents or adverse effects to the hemovigilance correspondent. In addition, the blood transfusion safety and hemovigilance committees, present in public hospitals, ensure the implementation of corrective and preventive measures.
Finally, the regional hemovigilance coordinator works at regional level, in collaboration with the regional health departments, to ensure consistency and follow-up of actions at local level.
Partnerships with blood transfusion organizations
Hemovigilance is also based on close collaboration with blood transfusion organizations, mainly the French Blood Establishment (EFS). The latter provides labile blood products, participates in quality control and screening in donors. The hemovigilance correspondents of the transfusion centers report to the ANSM any serious adverse effect occurring in a donor or any incident in the transfusion chain.
This collaboration is essential to ensure traceability and safety throughout the transfusion chain. The National Agency for Medicines and Health Products Safety (ANSM), as the national reference body, coordinates and supervises the entire system at the national level. This strong partnership between institutional actors and healthcare facilities ensures a rigorous and effective hemovigilance system.
Products concerned by hemovigilance
Different labile blood products
Labile blood products (LBP) include several types of components derived from blood donation, each with specific characteristics and therapeutic indications. Among them, the main ones are:
- Packed red blood cells (PRBCs), used to correct anemia by delivering oxygen to the tissues.
- Platelet concentrates (PCs), intended to restore hemostasis in patients with thrombocytopenia or platelet dysfunction.
- Fresh frozen plasma (FFP), used to treat coagulation disorders by providing essential plasma factors.
- Granulocyte concentrate mixtures, used more rarely for specific cases of severe immune deficiency.
These products are subject to numerous qualifications, such as phenotyping, to minimize immunological risks and ensure optimal compatibility with the recipient. The characteristics and official list of labile blood products (LBPs) are regularly updated by the competent authorities to adapt to medical and technical advances.
Quality and safety criteria
Quality and safety of labile blood products are absolute priorities in transfusion management. Each product must meet strict requirements regarding its preparation, quality control, storage and transport.
These criteria ensure the integrity of blood components throughout the transfusion chain. Key measures include:
- Leukocyte reduction, to reduce immune reactions.
- Rigorous batch traceability.
- The qualification of products to prevent complications such as alloimmunization or the transmission of infectious agents.
Permanent monitoring via hemovigilance makes it possible to identify and control undesirable effects occurring after transfusion, thus ensuring constant improvement in transfusion safety for the benefit of the patient.
The hemovigilance reporting procedure
Identification and management of transfusion incidents
The hemovigilance reporting procedure begins with the rigorous identification of any incident or adverse effect occurring in a patient receiving labile blood products. It is imperative that all healthcare professionals immediately report any adverse effect, especially serious incidents, to the hemovigilance correspondent of their hospital.
These correspondents, often physicians or pharmacists, are responsible for the management and analysis of reported cases. They conduct thorough investigations, which may include additional examinations, to determine the origin of the incident. Declarations are made via the e-FIT tele-declaration application and then transmitted to the regional hemovigilance coordinator, the ANSM (National Agency for the Safety of Medicines and Health Products), and the French Blood Establishment (EFS).
Reporting times vary depending on the severity of the incidents, with some requiring urgent reporting. This procedure allows for better risk assessment and promotes the development of appropriate corrective measures to prevent the recurrence of adverse transfusion-related events.
The Importance of Blood Product Traceability
Traceability is an essential element in the transfusion chain and plays a key role in the safety of transfusion procedures. It ensures precise monitoring of each blood product unit, from its collection from the donor to its administration to the patient. Each step is meticulously documented, encompassing identification controls, storage and transport conditions, as well as the delivery of products to healthcare facilities.
This traceability is essential to ensure not only the quality and safety of labile blood products, but also to allow for a rapid response in the event of an incident or adverse effect. It thus facilitates the investigation of causes and the management of consequences. In addition, it constitutes a regulatory obligation for all actors in blood transfusion, contributing to enhanced vigilance and continuous improvement of transfusion safety.
Risk management and prevention practices
Transfusion risk assessment
Risk assessment in blood transfusion is an essential step to guarantee transfusion safety. It is based on a systematic analysis of potential hazards throughout the transfusion chain, from collection from donors to administration to patients.
This assessment includes the identification of infectious and immunological risks, as well as procedural or compatibility errors. Specific methods, such as FMEA (Failure Mode and Effects Analysis), are used to detect system flaws and prioritize necessary corrective actions.
The objective is to prevent and reduce as much as possible the adverse effects associated with transfusions, while ensuring optimal quality of the labile blood products used in transfusion therapy.
Prevention and management measures for adverse effects
Prevention practices in hemovigilance are based on rigorous protocols validated by the National Agency for the Safety of Medicines and Health Products (ANSM). Key measures include thorough screening of infectious agents in donors, biological qualification of blood products, and continuous training of medical teams to ensure safe administration.
In the event of a transfusion-related adverse reaction, rapid and coordinated management is essential. This includes immediate reporting to the hemovigilance correspondent, appropriate patient management, and rigorous medical follow-up to prevent recurrence.
These approaches, combined with continuous vigilance and regular audits, help to reduce incidents and strengthen the overall quality of transfusion care.
Training and awareness on hemovigilance
Training programs for healthcare professionals
To ensure quality and transfusion safety, specialized training programs are available to healthcare professionals involved in the transfusion chain. These trainings offer the opportunity to update their knowledge on labile blood products, compatibility rules, as well as the recognition and management of transfusion adverse effects.
They also cover the regulatory obligations defined by the National Agency for Medicines and Health Products Safety (ANSM) and deepen the organization of hemovigilance. Structured around theoretical and practical modules, these trainings are aimed at a wide range of professionals, such as physicians, nurses, pharmacists and other healthcare personnel. They are often validated by certifications such as the DPC (Continuing Professional Development).
A central point of these training courses is to emphasize the importance of the role of the hemovigilance correspondent and to promote the best practices essential to reducing transfusion-related risks.
The implementation of awareness campaigns
In addition to training courses, awareness of hemovigilance is part of an ongoing process within healthcare facilities. Targeted information campaigns are regularly organized to remind staff of the reporting procedures, the importance of traceability of blood products, and the actions to be taken in the event of an adverse effect.
These campaigns rely on a variety of materials, including posters, newsletters, and practical workshops. Their goal is to encourage the involvement of all care teams. By cultivating a culture of vigilance and shared responsibility, these initiatives help strengthen transfusion safety and maintain the trust of donors and patients.
Tools and resources for professionals
Hemovigilance guides and protocols
Healthcare professionals have numerous guides and hemovigilance protocols to ensure rigorous and safe management of blood transfusion procedures. These documents provide clear recommendations on the procedures to follow, from prescription to management of potential adverse effects.
In particular, they specify the essential steps of the transfusion process, best practices regarding patient identification, traceability of labile blood products, as well as the actions to be taken in the event of transfusion incidents. These protocols are developed by reference institutions such as the French Blood Establishment and the National Agency for the Safety of Medicines and Health Products (ANSM). These organizations ensure a coherent national regulatory framework that is adapted to the current challenges of transfusion safety.
Computer support and dedicated software
To simplify data management and improve incident reporting, specific IT tools for hemovigilance are made available to hospitals. This specialized software allows for the rapid collection, analysis, and transmission of information relating to incidents and adverse effects.
Among these tools, the national application e-FIT is widely used for the electronic reporting of recipient adverse reaction forms. It guarantees a secure and standardized transmission of data to the competent authorities. These systems reinforce the complete traceability of the transfusion chain and facilitate coordination between the various stakeholders, from healthcare facilities to the regional hemovigilance coordinator and the ANSM. Thanks to these technologies, the monitoring and evaluation of transfusion safety are optimized, thus contributing to better risk prevention.
Conclusion
Hemovigilance plays an indispensable role in guaranteeing transfusion safety at each stage of the process, from collection from donors to the follow-up of patients recipients. It is based on increased vigilance, rigorous reporting of adverse effects, and close collaboration between healthcare facilities, the French Blood Establishment, and the ANSM. To effectively protect all stakeholders, it is essential that each professional actively invests in the application of good hemovigilance practices and participates in dedicated training programs.
Act today to strengthen transfusion safety and ensure the safety of the blood product pathway throughout the chain.
FAQ
What is hemovigilance and what is its primary role in transfusion safety?
Hemovigilance is a health monitoring system that monitors the entire blood transfusion chain, from blood collection to the follow-up of recipients. Its main objective is to prevent and evaluate the adverse effects associated with the use of blood products.
What types of adverse events should healthcare professionals report to a hemovigilance system?
Within a hemovigilance system, healthcare professionals must report serious adverse effects in donors as well as incidents or reactions related to transfusion. This includes:
- Identification errors,
- Inadequate blood products,
- Allergic reactions,
- Alloimmunization.
- Anomalies related to massive transfusion,
- And any deviation from established protocols.
What are the key steps in the ultimate bedside check prior to blood transfusion?
Prior to a blood transfusion, it is essential to perform a final bedside check. Here are the key steps:
- Verification of patient identity by questioning or via wristband,
- Consistency between medical documents and the blood product (phenotypes, number, expiration date).
- Visual inspection of the product and ABO-Rh biological compatibility test by agglutination.
Who is responsible for reporting and managing transfusion-related incidents as part of a hemovigilance system?
The responsibility for declaring and managing transfusion incidents lies with:
- To healthcare professionals,
- To haemovigilance correspondents,
- And to regulatory bodies, such as the ANSM in France.
These stakeholders collaborate closely to report and analyze incidents in order to improve transfusion safety.
