10.2 HAEMOVIGILANCE (HV), ARCHETYPE OF V&S FOR MPHO

The scope of the project started including organs, tissues and cells for transplantation and for assisted reproduction. Ten working groups collaborated in the effort. The work was conducted on a WIKI site where over 100 participants (regulators, clinicians, professional society representatives, scientific experts) collaborated to gather documented cases of occurrences across the scope of the substances under consideration, using published articles and vigilance system reports as their sources. Over 1,900 published references were inserted on the site. The cases were used as the basis for developing draft guidance on the detection and confirmation of occurrences, with an emphasis on the key role of the treating physician.
 
BLOOD HAS SHOWN THE WAY FOR THE DEVELOPMENT OF V&S FOR MPHO
Blood products and blood transfusion lead MPHO by the time span of experience of more than a century of blood transfusion as well as the scope of activities. The WHO global database on blood safety estimated that 108 million units of blood were collected for transfusion in 2012.
 
BLOOD TRANSFUSION LINKS TWO CULTURES: A CULTURE OF PRODUCTION AND A CLINICAL CULTURE  
The industrial scale of blood donation and of processing for clinical application led to the implementation of quality systems progressively from the beginning of the 70’s. Institutions with multiple establishments and quality management systems shared Information on non-conformity, post marketing surveillance and other adverse occurrences.
 
BLOOD TRANSFUSION ILLUSTRATED RISKS FOR PATIENTS AND DONORS 
The human donor defines MPHO. The outcomes of blood donation for transfusion are crucial to the good functioning of the blood service. Clinical activities in blood transfusion involve recipients but also donors.
Donor safety is crucial to the credibility of the blood service. Risks must be minimal for donors, nevertheless rare complications do occur even with the most innocuous forms of donation. Blood donors are volunteers who must understand that their donation is respected and will be used for the best outcomes for the recipient. Therefore a thorough V&S system to optimize practices contributes to building up trust in the MPHO service as a community resource and motivation to donate.
 
BLOOD TRANSFUSION HAS SHOWN THE VALUE OF DISCOVERY OF ADVERSE OCCURRENCES THAT DO NOT LEAD TO HARM
Events (or mistakes) that occur in the processes that accompany blood transfusion can sometimes be identified prior to the transfusion and patient harm. These can be used as valuable warnings and learning lessons for the transfusion service. An example of this type of event, sometimes called a “near miss”  is an ABO mismatch that is spotted at the bedside when preparing the patient for transfusion.  
 
OVER THE COURSE OF TIME, BLOOD TRANSFUSION HAS REVEALED THE VAST RANGE OF TYPES OF ADVERSE OCCURRENCES 
Transfusion transmitted infections are a good example of these types of events. Many of the types of adverse occurrences that occur in the process of collecting and transfusing blood and blood components are also observed with other MPHO. Few are specific only to blood. Whether there is actual harm or risk of harm, the same root cause analysis and risk management should be undertaken. 
 
BLOOD TRANSFUSION HAS PIONEERED INTERFACES WITH OTHER SURVEILLANCE SYSTEMS
• Pharmacovigilance through plasma derived medicinal products and with drugs used by donors e.g.: transfusion transmitted infections (TTIs), Heparin.
• Device vigilance when faulty equipment or disposables are the cause of danger e.g.: blood bags, test kits, IT systems.
• Clinical governance and its risk management component: wrong unit, transfusion associated circulatory overload (TACO).
 
Blood provides the example for all MPHO of the need to bring together information from various vigilance systems to generate a true comprehensive map of associated risks. The best possible information on risk is necessary for donors and recipients and their clinicians, as well as for all actors in the chain who must collaborate to ensure safety and prevention of future adverse events. This may be an industrial partner who will respond to blood transfusion establishments and clinical settings. Blood demonstrates that vigilance systems must have overlap and redundancy with good inter-organisational communication patterns for success. 
 
In the last three decades good transfusion practices evolved into mandates that prescriptions, practices and outcomes are submitted to a systematic review. The assessment of outcomes developed as part of the transfusion procedure has evolved to being a required element of blood transfusion.  
 
HV HAS DEMONSTRATED ITS EFFICACY BY IMPROVING BLOOD TRANSFUSION PRACTICES 
National data consolidation, review and analysis of adverse occurrences has led to recognition, quantification with denominator, prioritization and successful management of risks that were previously unknown or underestimated, including e.g. bacterial infections, transfusion-related acute lung injury (TRALI) and transfusion associated circulatory overload (TACO).  
 
THERE IS DIVERSITY IN NATIONAL HV SYSTEMS BUT THEY RETAIN COMMON OBJECTIVES OF PATIENT SAFETY AND QUALITY IMPROVEMENT
National HV systems were established with different principles and structures in various countries. For instance reporting may be voluntary or mandatory, the responsible institution may be the regulatory authorities or it may be outsourced to a specific body or a relevant scientific and professional society. Likewise the scope of HV can be different from one country to another. It may be focused on any actual harm to patients transfused, only on transmission of infectious diseases, or on serious or lethal events. Adverse occurrence without harm to individuals (“near miss” or risk of harm) may not be required reporting in some HV systems. Conversely some HV systems require the reporting of any incident beyond deviations addressed by a quality management system.  
 
However, all HV systems have contributed to developing an on-going dialogue between the stakeholders in transfusion safety quality and availability, namely operators, clinicians and appropriate health authorities where regulators and policy makers can be recognized. They share the responsibility of meeting patients’ needs and protecting donors as well as society, where anyone has the potential to need file-saving blood components. HV has evolved as a necessary tool to achieve this goal. Progressively with the recognition of the value of national HV systems, a global consensus took shape on what should be an ideal HV system. It is summarized by the WHO definition: 
 
Definition: Haemovigilance is a set of surveillance procedures covering the entire transfusion chain, from the donation and processing of blood and its components, to their provision and transfusion to patients and their follow-up. Haemovigilance includes the monitoring, reporting, investigation and analysis of adverse events related to the donation, processing and transfusion of blood, as well as the development and implementation of recommendations to prevent their occurrence or recurrence. 
 
HV system: a recognised factor of progress for transfusion services in low and middle income countries
In developing countries, rather than seeking to mimic the HV systems of developed countries, the priority is to correct deficiencies that are already apparent and obvious with whatever resources are available. The first step is often to correct fragmentation and foster an actual national service with an effective oversight where HV will show its value.
HV systems adapted to the local reality and introduced in a stepwise manner to yield reliable and accurate data are now recognized vectors of progress. The HV system delineates roles and responsibilities and enhances communication between stakeholders. 
Blood transfusion an example of budding global dynamics for HV
 
Sharing of standardized information is key to HV. In the infancy of national HV systems professionals recognized the need for regional and global standards and communication. The ISBT has a specific working party and the IHN resulted from the global expansion of the EHN. Recent WHO consultations have projected global resources for HV that would provide a national system with reference information and experience. 
HV has shown the way for the development of V&S services for other MPHO. The responsibility for the donor as well as for the recipient common to MPHOs and the community of adverse occurrences led to develop the Notify Project where HV is a key source of inspiration and serves as a model. The description for what should be included in a HV system is available elsewhere (18)