Introduction
Hemovigilance is a term derived from Greek in which he refers to blood and vigilance refers to watchfulness. Hemovigilance aims to enable safe blood transfusions. The whole blood, erythrocyte concentrates, thrombocyte concentrates, and fresh frozen plasma are investigated for adverse blood transfusion reactions. The data collected from the hemovigilance system helps form changes in whole blood transfusion procedures.
What Is a Blood Transfusion?
Blood transfusion is a procedure carried out frequently in which donated blood and its components are administered intravenously to a patient. The procedure requires one to four hours, depending on how much blood is administered. The procedure is generally safe and includes multiple steps. However, there is a chance for adverse events due to the omission of quality checks. The error can arise while collecting blood from a donor, administering blood to the recipient, testing blood in the laboratory, and during bedside administration.
What Is Hemovigilance?
Hemovigilance can be described as a set of surveillance procedures that includes the blood transfusion chain, from donating and processing blood components to storing, transfusion to patients, and follow-up.
The procedure is continuously monitored, any adverse events of donations are investigated and reported, and action is taken to prevent the event's recurrence. The surveillance protocol helps improve patient safety by learning from adverse events and implementing prevention measures.
How Did Hemovigilance Come Into Existence?
The blood transfusion committee established a national hemovigilance system in France in 1994 for monitoring blood transfusion. In 1995, to improve blood safety and improve confidence in blood transfusions among the general population, a resolution was passed by the European Council to include governance of hemovigilance under legal authorities. Data from hemovigilance centers in various countries were collected to improve blood safety and introduce preventive measures.
In recent years, the International Hemovigilance Network (IHN) has been established globally to develop and maintain protocols regarding blood and its component safety and hemovigilance in blood transfusion. An international database known as the International Surveillance of Transfusion-associated Reactions and Events (ISTARE) was developed for data sharing on blood safety worldwide. Adverse events occurring during blood transfusion in recipients and side effects in donors are stored in the database.
What Is the Importance of the Hemovigilance System?
In previous times, there was a need for safe blood transfusions as hemophilia patients from developed countries developed infections of HIV (human immunodeficiency virus) and HCV (hepatitis C virus) from blood transfusions.
The scope of the hemovigilance system varies in different countries based on differences in reporting of adverse events. The hemovigilance data must include complete information on the whole transfusion chain procedure from blood donation, processing, monitoring, reporting, and investigation of side effects. The reported adverse events can be severe or only occur in the recipient or donor. There must be synchronization between blood transfusion centers, hospital staff, blood transfusion laboratories, committees of blood transfusion, and national health authorities for efficient data collection.
What Are the Components of Hemovigilance?
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Recipient Hemovigilance: The severity of adverse reaction resulting from blood transfusion to the recipient is graded according to a scale accepted internationally. The imputability of blood components is also a factor in the occurrence of adverse events. The International Society of Blood Transfusions (ISBT) has established guidelines for determining the severity and imputability of blood transfusion reactions. Adverse reactions to blood transfusion in recipients are categorized as either acute or delayed. Acute reactions manifest within 24 hours of the transfusion, while delayed reactions occur after several hours.
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Donor Hemovigilance: Reporting hemovigilance from blood donors must include any unexpected adverse events in whole blood or its components and steps taken to prevent them. The complications arise from blood donation, selection of donors, and management of donors that can directly influence blood quality or harm donors. A comprehensive data collection and analysis of adverse events can aid in identifying blood donors at risk of reaction and form strategies to mitigate them. The ISBT organization has established The Severity Grading Tool for Donor Adverse Events to determine the severity of adverse reactions in the donor. The severity is graded as one to five and is described as mild, moderate, severe, life-threatening, and death. A grade greater than 3 is considered serious while reporting.
However, in Asian and developing countries, there is no well-established hemovigilance for recording and reporting adverse reactions in donors. In India, there is a recommendation to establish a hemovigilance system through National Blood Policy. An effective hemovigilance system can be established by a streamlined data collection approach and by using standardized tools at the hospital level. The data obtained helps monitor blood transfusion safety.
What Is the Hemovigilance System in India?
The hemovigilance program was launched in 2012 in India and included a functional core group and advisory committee. They are responsible for coordinating hemovigilance between medical colleges and the National Coordination Centre and can also provide expert opinions on the data generated. The advisory committees enable data transfer from the Hemovigilance program in India to IHN. The committees also established Transfusion Reaction Reporting Form (TRRF) and Hemovigil software to improve efficiency in reporting.
In case medical colleges report any blood transfusion reaction or blood product administration adverse events, the data is filled in TRRF and forwarded to National Coordination Committee through hemovigil software. The recommendations from obtained data are sent to the higher regulatory body to form blood safety guidelines.
What Is a Hemovigilance Module?
The hemovigilance module is a component of biovigilance established by the National Health Safety Network in the United States. They collect two types of data regarding transfusion-related adverse events: incidents (errors or near misses) and patient adverse reactions. The data is collected from annual and monthly facility surveys, incident summaries, and adverse reaction and incident forms. The biovigilance unit contains demographic information about the facility, total transfused blood units, and adverse reactions to estimate negative event rates.
Conclusion
Hemovigilance is a necessary mechanism to ensure safety in blood collection and transfusion. Establishing a hemovigilance system has reduced the risk of adverse events and infections in recipients and donors. However, different countries have established hemovigilance systems with diverse data collection and analysis methods. International organizations prevent differences by establishing guidelines for data collection. They also help formulate preventive measures based on data collected from other countries.
