2 The V&S Chain for MPHOs

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History Vigilance and Surveillance (V&S).

Vigilance and surveillance is a collective term to describe the systematic, ongoing collection, collation and analysis of adverse outcome data for public health purposes and their timely dissemination for assessment and response as necessary. Biovigilance is the term used for the monitoring of adverse outcomes associated with MPHO. This link provides general background information.


Medical products of Human Origin (MPHO) Donation and Ethics

Advances in science and healthcare technology have led to more biologic products being collected to sustain and improve the quality of human life. Challenges exist to monitor and ensure appropriate access and availability of safe products both in the domestic and global arenas.  This link focuses on the donor-facing aspects of vigilance and the need to project and care for donors.


Towards a global governance of MPHO.

In 2004, the World Health Assembly adopted Resolution WHA57.18 on Cell, Tissue and Organ Transplantation.  In close collaboration with relevant scientific and professional societies and national health authorities, the World Health Organization (WHO) updated its Guiding Principles for cell, tissue and organ transplantation. WHO and all stakeholders engaged in activities to improve and harmonize access to safe, effective and ethical transplantation at national and regional level. Guiding Principle 10 and World Health Assembly Resolution WHA63.22 urges Member States to develop vigilance and surveillance of adverse outcomes and the Resolution also asks WHO to facilitate Member States’ access to this information.    This link describes the global initiatives to improve vigilance of MPHO.


The V&S system is primarily a responsibility for health authorities  

National health authorities require timely reporting of severe occurrences arising in the practice of cell tissue and organ transplantation and assisted reproduction, whether they led to harm or could have led to harm. Cases where there has been harm to a donor, harm to a recipient or harm to a child born following in vitro-fertilisation, or a risk of serious harm has been detected, must be identified and reported. Several systems for the collection of data and their exploitation have been developed in various countries, whether run by the authorities or outsourced to scientific and professional societies. This link highlights the role of health authorities and professional societies in putting systematic vigilance systems in place.


Organization for a comprehensive Vigilance & Surveillance System

A comprehensive V&S system has a number of key elements that must be taken into consideration, described in this link.


Vigilance & Surveillance first relies on health care staff

Physician and nurses in particular have the responsibility to identify occurrences adverse occurrences and to report them through the appropriate national channel. V&S is a not a punitive system. It aims to improve and maximize safety, and therefore the trust of the public, MPHO donation and transplantation service. Attention to quality management in health care can bring a more rigorous and systematic approach to addressing documented deficiencies and cost savings. This link addresses health professionals highlighting their critical role in vigilance.


Investigating occurrences that could cause harm

The investigation of occurrences that imply risk essentially comprises a ‘root cause analysis’ process (RCA).   RCA is a structured approach to identifying the factors that resulted in the nature, the magnitude, the location, and the timing of a harmful, or potentially harmful, outcome. This link gives information for those who need to investigate such occurrences.


Project Notify  

WHO, the Italian National Transplant Centre (CNT) and the EU-funded Project ‘Vigilance and Surveillance of Substances of Human Origin’ (MPHO V&S) joined forces to organize a major global initiative aimed at raising the profile of vigilance and surveillance (V&S) of substances of human origin and maximizing the didactic value of adverse outcomes. The initiative was called Project Notify). This link describes the project.


Learning from Vigilance - The Notify Database.

A new open access, searchable website (a Vigilance Knowledge Base) has been established to host, maintain and update the library of documented occurrences adverse occurrences that has been developed. This link describes the tool that is invaluable to clinical users. (www.notifylibrary.org)


Risks Associated with Living Donation.

Living donors can provide both allografts and autografts for transplantation of cells, tissues and organs. Such donations carry inherent risks that must be recognized both for patient safety and recognition for purposes of vigilance and surveillance. This link gives guidance for those active in promoting and organizing donation of MPHO.


Investigating Harm to Recipients - Infections

The recognition of infections transmitted through an allograft is crucial for diagnosis and treatment of the transplanted or transfused patient, both for better health outcomes of the recipient and also to prevent further disease transmission to those who have been transplanted with organs and tissues or transfused with blood products derived from the same donor. This link provides guidance for transfusion and transplantation professionals who investigate suspected infectious transmissions together with the clinician treating the patient.


Investigating Harm to Recipients - Malignancy

The prompt identification of transmission risks and a high index of suspicion of transmitted diseases are essential and constitute the critical steps in international vigilance and surveillance applied to MPHO. Although the risk of malignancy transmission has been examined and reported since the first years of clinical transplantation, the frequency of donors with malignant tumors and the risk of transmission of malignant diseases from donors to recipients are clear. This link provides guidance to professionals who need to investigate suspected transmissions.


Investigating Occurrences Harm to Recipients - Genetic Transmissions, HPSC

The establishment of haematopoietic stem cell  (HPC) donor registries and public cord blood banks worldwide has increased the availability of grafts from unrelated donors for patients requiring stem cell transplantation. Theoretically, all congenital diseases originating from bone marrow-derived cells are transmissible. This link is useful for those investigating genetic transmissions by HPC.


Investigating Harm to Offspring - Genetic Transmissions, Gametes and Embryos

Although these events are not numerous, they show the need to consider the potential of genetic disease transmission using donor gametes. Gametes are the only cells that carry such genetic material, which could potentially affect the recipient (offspring) with any genetic disease. This link is useful for those investigating genetic transmissions in the field of assisted reproduction.


Characteristics, handling and clinical errors

Each cell, tissue or organ allograft intended for transplantation, implantation, infusion or transfer has specific quality attributes and characteristics determined by anatomy and usual function.  Handling activities that support the maintenance of desired efficacy or utility of the MPHO can affect clinical outcome. When a gap exists or a step or process fails, a risk of harm or actual harm can occur in which case a root cause analysis should be performed. This link provides guidance on the investigation of process errors.


Traceability - the absolute pre-requisite

Traceability’ denotes the ability to locate and identify the tissue/cell during any step from procurement, through processing, testing and storage, to distribution to the recipient or disposal, which also implies the ability to identify the donor and the tissue establishment or the manufacturing facility receiving, processing or storing the tissue/cells, and the ability to identify the recipient(s) at the medical facility/facilities applying the tissue/cells to the recipient(s). Traceability also covers the ability to locate and identify all relevant data relating to products and materials coming into contact with those tissues/cells but also confirmation that transfusion/transplantation (or final disposal) actually took place.  This link highlights the need for those involved in donation and clinical application of MPHO to ensure reliable traceability.