Monday July 02, 2018 from 16:30 to 17:30
New Strategy for Deceased Organ Donor Serology Testing Following two Serious Adverse Occurrences
Aurora Navarro Martinez-Cantullera1, Teresa Pont2, David Paredes3, Mikel Martinez4, Ana Requena-Mendez6, Tomas Pumarola7, Elena Sulleiro7, Oscar Len8, Silvia Sauleda9, Asuncion Moreno5, Anna Vilarrodona10, Marga Sanromà1, Jaume Tort1, Francisco Caballero11.
1Organització Catalana de Trasplantaments, Barcelona, Spain; 2Donation and Trasplantation Programs, University Hospital Vall d´Hebron, Barcelona, Spain; 3Donation and Transplant Coordination Section, Hospital Clinic, Barcelona, Spain; 4Department of Microbiology, Hospital Clinic, Barcelona, Spain; 5Infectious disease, Hospital Cinic, Barcelona, Spain; 6ISGlobal-CRESIB, Hospital Clinic, Barcelona, Spain; 7Microbiology, University Hospital Vall d´Hebron, Barcelona, Spain; 8Infectious disease, University Hospital Vall d´Hebron, Barcelona, Spain; 9Transfusion safety laboratory, Banc de sang i teixits, Barcelona, Spain; 10Barcelona tissue bank, Banc de sang i teixits, Barcelona, Spain; 11Transplant Coordination, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Introduction: In 1984 the Catalan Transplant Organisation (OCATT) was established to plan, manage and coordinate activities related to organ and tissue donation and transplantation. In recent years, vigilance and surveillance (V&S) activities have been implemented as a transverse process throughout the organization.
Materials and Methods: V&S programs are essential to improve quality and safety for organ transplantation. Adverse events are rare but reporting any incidents are a key part of the V&S system, facilitating the detection of residual risks or unexpected errors that can lead to a severe adverse occurrence (SAO). There are many different factors that can challenge effective SAO reporting, such as lack of detection, lack of well-identified responsibilities, time constraints for investigation or a blame culture among professionals. Other factors may influence the process in a positive way, e.g. clear and user-friendly V&S protocols, in-hospital trained vigilance coordinators and an efficient vigilance office that coordinates V&S.
The experience presented is an example of how sharing the investigation of two cases of SAO disease transmission may result in an in-depth review of the deceased donor’s serology screening characterization and the analysis of new emerging disease risks in a donor population.
Results: Two SAO related to new emerging disease transmissions were reported to the OCATT vigilance office. Both cases had a score of 15 after applying a V&S impact matrix that ranges from 1 to 20, taking severity and probability of recurrence into account. The notification centres implemented a series of corrective actions, addressing internal procedures, governance structure, personnel and organizational issues.
The health authority designated a multidisciplinary task force of experts (microbiologists, transplant coordinators, blood and tissue bank, vigilance office and infectious disease) to analyze the donor serology tests and any newly identified risks (Figure1). The group analysed the risks and a new organ donor serology screening strategy was proposed (Figure 2). To detect risks among organ donors a new specifically oriented questionnaire has been developed; a strategic screening has been advised and reference microbiology labs will make available the techniques that will give reliable results.
Conclusions: Procurement organizations and transplant communities reporting SAO to V&S programs are crucial to improve recipient’s safety. Health authorities have to organize well structured V&S systems to promote reporting, investigation in the context of a no blame culture. In this case, two SAO reports resulted in the establishment of a multidisciplinary task force to analyze organ donor serology screening and new emerging disease risks in the region. New proposals for organ donor serology screening covering all the different risks detected should decrease still more, the risk of potential disease transmission to the recipient community.