Dissertation committee:
Παναγιώτης Τσιριγώτης, Αν. Καθηγητής, Ιατρική, ΕΚΠΑ
Γεώργιος Δημητριάδης, Καθηγητής, Ιατρική, ΕΚΠΑ
Ιωάννης Ν. Μπολέτης, Καθηγητής, Ιατρική, ΕΚΠΑ
Ανδρέας Καραμπίνης, Καθηγητής, Ιατρική, ΕΚΠΑ
Μάρκος Σαρρής, Διοίκηση Επιχειρήσεων, ΠΑΔΑ
Δημήτριος Βλαχάκος, Αν. Καθηγητής, Ιατρική ΕΚΠΑ
Φλώρα Κοντοπίδου, Επίκουρη Καθηγήτρια, Ιατρική, ΕΚΠΑ
Summary:
Progress in science and technology in the health services has led to the development of methods of regenerating and replacing solid organs, tissues and cells, using human body components to create medical products of human origin intended for clinical use. In the activities in which products of human origin are used, however, from the point of donation and harvesting to the subsequent care of the recipient, medicinal products of human origin are exposed to the risk of specific complications related to the transmission of infectious diseases, and other side-effects.
The Management of the above risks it is based on the imputability and notification of Serious Adverse Events (SAE) and reactions (SAR), in order all products of human origin are effectively protected in the context of operating a system of Biovigilance. The objective of the Biovigilance system is the timely and valid warning for all possible SAE and SAR, satisfying the need for the quality and safety of the tissues and cells for transplantation.
Creating a system for recording and reporting adverse events is one of the most important preventive measures. Through this, it is possible to study and analyse the various causes of the creation of adverse events, Improves Learning and knowledge also reinforces the continuous monitoring of the progress of adverse events (indicators of increase/decrease of errors and incidents, indicators of response, prevention indicators, etc.).
This dissertation attempts to contribute to the investigation and mapping of organizational behavioral and cultural change factors regarding the reporting and imputability procedures for adverse events and reactions to the operating framework of a Biovigillance system for the quality and safety of tissues and cells for transplantation.
The research purpose is the primary data collection relating to the exploration of health providers opinion of bone marrow transplant units concerning the factors influence and determine opinion formation and attitude formation in the reporting of serious adverse events and reactions of the donor health maintenance and the safety of the recipient.
For data collection, a specific questionnaire was used in which eleven (11) factors were identified: assessment of knowledge competence, detection of adverse events and reactions, reporting of adverse events and reactions, imputability of adverse reactions, imputability of adverse events, management of human error, configurations of perceptions in managing adverse events and reactions, organizational behavior, organizational culture and human resources attitudes.
The study population refers to the team of staff (doctors, nurses, other specialties) who provide their services to Bone Marrow Transplantation Units (BMTU) and Haematology Clinics that perform autologous transplants of public hospitals in Attica (Alexandra University Hospital, Evaggelismos General Hospital, “Georgios Genimatas” General Hospital, Children’s Oncology Hospital - Hope). In addition to the sample participate the health officials of Haematology Clinic of the University Hospital of Heraklion, Crete.
The main findings of the study positively support the establishment of measures to prevent and improve the quality and safety of tissues and cells for the benefit of patients and staff, which relating mainly:
Creating a system for vigilance and surveillance of adverse events and reactions,
Establishing the organizational culture of quality and safety for the patient and personnel,
Improving the communication of health professionals between different specialties,
Availability of adequate and quality personnel,
Continuous training of human resources in the management of adverse events and reactions,
Biovigilance system development.
Medical centers (procurement organizations, tissue and cell establishments, organisations for human application) involved and are key elements of the transplantation system and they should promote a new culture of change and modification of conventional behavior in the workplace and formulate new patterns of behavior, attitudes and perceptions regarding the submission, reporting and notification of SAE and SAR.
With the application of modern and specialised know-how relating to all procedures/processes from donation to transplantation of tissues and cells, health units can be integrated into a unified traceability network to report serious adverse events and reactions.
Biovigilance system application is a basic requirement for ensuring the quality and safety of medical product of human origin intended for human application. The quality system focuses on error prevention, maintaining a consistent pattern of agreed assays for tissues and cells intended for clinical use.
Taking into account that in Greece there has not been developed a system of reporting of SAE and SAR and a system of vigilance and surveillance, the formation of positive opinion, behavior and attitudes of human potential towards the conscious acceptance of bio-vigilance is considered as a necessary condition for the successful development of a national biovigilance system, which will also act as part of the European and international biovigilance system.
