ISO quality certification for a hospital-based organ procurement unit: The United Arab Emirates (UAE) experience
María Paula Gómez2, Ali Al Obaidli1, Francesco Procaccio2,3, Reginaldo Boni5, Verónica González6, Marián Irazábal2, Maria Barros2, Martí Manyalich2,4,7.
1UAE National Transplant Committee - Abu Dhabi Health Services SEHA, Abu Dhabi, United Arab Emirates; 2DTI Foundation - Donation and Transplantation Institute, Barcelona, Spain; 3National Transplantation Council of the Italian Health Institute , Rome, Italy; 4Faculty of Medicine, University of Barcelona, Barcelona, Spain; 5Santa Casa de Sao Paulo , Sao Paulo, Brazil; 6Banc de Sang i de Teixits, Barcelona, Spain; 7Hospital Clínic i Provincial de Barcelona, Barcelona, Spain
Introduction: Self-sufficiency in organ donation is every nation’s goal as stated by the Third Global Consultation on Organ Donation and Transplantation (Madrid, 2010). Acknowledging the complexity and singularities of the UAE society is essential to understand its capacity to grow. UAE´S Human Development Index (HDI) is ranked at the very highest development category (35 out of 189 countries), the country accounts with a good medical infrastructure and availability of medical experts in all specialities. No other country in the world has 88.5% of foreign population with more than 200 nationalities, creating a multi-ethnic, multifaith and multicultural nation. Nevertheless, brain death certification law was approved on July 2017, from that DTI Foundation and UAE National Transplant Committee have been cooperating for the establishment and consolidation of a deceased organ donation program.
Materials and Methods: Four hospitals in Abu Dhabi were selected to initiate the ISO 9001:2015 organ procurement unit quality certification process. All four Hospitals directives expressed their commitment with the hospital-based organ procurement unit (H-OPU) implementation and ISO quality certification.
All units worked around seven spheres: context, leadership, planning, support, operation, evaluation and improvement. Deceased organ donation process mapping, unit core processes, structural and governance procedures were defined and implemented. Quality objectives and Key Performance Indicators in organ donation were agreed and measured between local and international experts. A monthly registry that contains all the activity of the H-OPU was gathered and analysed together with DTI experts. International experts’ visits to accompany the H-OPU set-up were scheduled.
Internal audits performed by the international team were completed for all hospitals and covered both, documentation and effectiveness of the process.
Results and Discussion: One out of four H-OPU was ready to apply for the external audit and quality certification. The internal audit reported 15 requirements achieved, 7 minor non-conformities and 4 major non-conformities related with the support and evaluation spheres. The major non-conformities were corrected in time for the external audit. ISO 9001:2015 certification was granted to one H-OPU after a 9-month process.
Conclusion: A third level donor hospital in Abu Dhabi implemented the first H-OPU in the country. The unit developed and certified its quality system in deceased organ donation, which helps to manage their deceased organ donors’ cases.
Establishing a self-sufficient and sustainable organ donation program is a multifaceted process. The main elements to be considered are supportive hospitals’ governance, governmental endorsement, a robust educational program to expand the proficient professionals’ pool and international collaboration; all of them elements of a quality system.