Quality management system applied to organ donation: United Arab Emirates experience

BACKGROUND: The 3rd Global Consultation on Organ Donation and Transplantation stated that every nation should achieve self-sufficiency in organ donation. In the Middle East the deceased organ donation (DD) average rate is 2.29 donors/pmp. The United Arab Emirates (UAE) started their DD program in 2017 approving brain death declaration. UAE National Transplant Committee started an international collaboration with Donation and Transplantation Institute (DTI Foundation) in 2017 for the development of the DD program. In 2019, 4 hospital-based organ donation unit (H-ODU) were established in Abu Dhabi. The aim of this study was to combine the ISO 9001:2015 quality management system (QMS) and the Organ Donation European Quality System (ODEQUS) to improve DD. METHOD: SEUSA is based on the Spanish, European and USA models tailored to the local needs. The QMS used was a combination of the ISO with ODEQUS methodology. The Abu Dhabi hospitals were selected according to their DD potentiality. Monthly follow-up between H-ODU's staff and DTI team were performed to monitor SOPs development and ODEQUS KIPs measurement. After a 6 months implementation period, an internal audit was performed by a DTI experts in DD/ISO QMS. Finally, an external audit was performed and ISO 9001:2015 quality certification was granted. RESULTS: 10 SOPs regarding DD were developed per unit and 4 ODEQUS key indicators (KPI) were selected (Table 1). After completed the internal audits, 1 H-ODU applied for the external audit and quality certification. As a result of the measures implemented, UAE moved from 0 donors to 1.1 donors/pmp in 2019. Lastly, in 2020 the Abu Dhabi Department of Health released the KPIs as a mandate for all hospitals to improve DD performance. CONCLUSION: The collaboration between local and international organization supports the successful implementation of DD best practices in new regions.

Council of Europe Black Sea Area Project: International Cooperation for the Development of Activities Related to Donation and Transplantation of Organs in the Region.

BACKGROUND: In 2011, the European Directorate for the Quality of Medicines & Healthcare of the Council of Europe launched a 3-year collaborative project to address the organ shortage and improve access to transplant health services in Council of Europe member states in the Black Sea area (Armenia, Azerbaijan, Bulgaria, Georgia, Moldova, Romania, Turkey, Ukraine, and the Russian Federation) through the development of safe and ethical donation and transplantation programs. OBJECTIVE: Support the development of donation and transplantation programs through close interstate cooperation between national health organizations and relevant stakeholders. METHODOLOGY: Several work packages (WP) were established: WP1, project coordination (European Directorate for the Quality of Medicines & Healthcare); WP2, development and implementation of an effective legislative and financial framework (Czech Republic and France); WP3, establishment of National Transplant Authorities (Italy and Portugal); and WP4, clinical practices (DTI Foundation). Data collection, surveys, and expert visits allowed for the collection of first-hand information from each participant country at national, regional, and hospital levels. RESULTS: Data analysis showed the positive impact of the project represented by a tendency to increase the total donation rates (per million people) in the participant countries (2011 vs 2013): Azerbaijan, +7.3; Armenia, -0.7; Georgia, +3.3; Bulgaria, +0.9; Moldova, +2.5; Ukraine:, +0.8; Romania, +2.3; and Turkey, +2.7. CONCLUSIONS: Increases in total donation rates are the result of a number of initiatives in the Black Sea area, including the stepwise implementation of legislative, organizational and institutional country-specific recommendations tailored by the CoE, efforts of the respective Ministries of Health in each country and synergism with other European projects in the region. These countries should invest further in implementing the recommendations that emerged from this project to improve their organ donation and transplantation programs and progress toward self-sufficiency.

Successful Example of How to Implement and Develop a Deceased Organ Donation System in the Caribbean Region: Five-Year Experience of the SEUSA Program in Trinidad and Tobago.

BACKGROUND: The SEUSA program, the Donation and Transplantation Institute foundation consultancy program, was implemented in Trinidad and Tobago (T&T) in 2010 with the support of the National Organ Transplant Unit (NOTU) and the Ministry of Health of T&T. METHODS: The SEUSA program included (1) diagnosis of the current situation using the ODDS (Organ Donation Diagnostic Surveys); (2) creation of a human resources structure through Transplant Procurement Management (TPM); (3) detection of all brain and cardiac deaths in the hospitals implementing the DAS (Decease Alert System); (4) in-hospital awareness based on the EODS (Essentials in Organ Donation); and (5) external hospital audits. Additionally continued monitoring is performed. RESULTS: Thus far, thanks to implementation of the SEUSA program in Trinidad and Tobago 175, healthcare professionals have been exposed to training programs in the organ donation field. The Living Kidney Program was reinforced and the structure of the Deceased Donation (DD) network was defined. Since 2010, 485 potential organ donors have been detected, and 9 have become actual organ donors; 74 patients have received a kidney transplant (59 from living and 15 from deceased donors). CONCLUSIONS: This project results demonstrate that the application of the SEUSA program is an efficient methodology to develop DD programs that increase and consolidate transplant programs in the Caribbean region.

Nomogram for Predicting Time to Death After Withdrawal of Life-Sustaining Treatment in Patients With Devastating Neurological Injury.

Reliable prediction of time of death after withdrawal of life-sustaining treatment in patients with devastating neurological injury is crucial to successful donation after cardiac death. Herein, we conducted a study of 419 neurocritical patients who underwent life support withdrawal at four neurosurgical centers in China. Based on a retrospective cohort, we used multivariate Cox regression analysis to identify prognostic factors for patient death, which were then integrated into a nomogram. The model was calibrated and validated using data from an external retrospective cohort and a prospective cohort. We identified 10 variables that were incorporated into a nomogram. The C-indexes for predicting the 60-min death probability in the training, external validation and prospective validation cohorts were 0.96 (0.93-0.98), 0.94 (0.91-0.97), and 0.99 (0.97-1.00), respectively. The calibration plots after WLST showed an optimal agreement between the prediction of time to death by the nomogram and the actual observation for all cohorts. Then we identified 22, 26 and 37 as cut-points for risk stratification into four groups. Kaplan-Meier curves indicated distinct prognoses between patients in the different risk groups (p < 0.001). In conclusion, we have developed and validated a nomogram to accurately identify potential cardiac death donors in neurocritical patients in a Chinese population.

International Registry in Organ Donation and Transplantation--2013.

OBJECTIVE: The International Registry in Organ Donation and Transplantation (IRODaT) presents final data on worldwide donation and transplantation activity to the community. The purpose of this report is not only to present raw data, but also to make organ donation effectiveness rates a useful tool to reveal similarities between countries on an international level. MATERIALS AND METHODS: The IRODaT Registry produced this report of 2013 statistics thanks to the collaboration of the official reporters, professionals in coordination and transplant services from national transplant organizations, and from the Ministries of Health of each reported country. RESULTS: The actual deceased donors and living donors rates, according to the total number of donors, from 72 countries can be analyzed using IRODaT tools, allowing the comparison and study of tendencies and rates of organ donation and transplantation activity at an international scale. IRODaT has been collecting and disseminating worldwide data since 1998. In this issue, it is shown that most of the countries that report the major activity in actual deceased donors are located in the European region. On the other hand, regarding living organ donation, the country location is more varied, including countries from Africa, Asia, and America. CONCLUSIONS: The results obtained through the IRODaT Registry provide a quick, clear, and illustrative view of worldwide organ donation activity.

Organ Donation European Quality System: ODEQUS project methodology.

Differences in the number of organ donors among hospitals cannot be explained only by the number of intensive care unit beds used or neurologic patients treated. The figures obtained are influenced by the organizational structure of the donation process and how efficient it is. The Organ Donation European Quality System (ODEQUS) is a 3-year project (from October 2010 to September 2013) co-financed by the European Agency for Health and Consumers (EAHC20091108) which aims to define a methodology to evaluate organ procurement performance at the hospital level. ODEQUS's specific objectives are to identify quality criteria and to develop quality indicators in three types of organ donation (after brain death, after cardiac death, and living donation). Those tools will be useful for hospitals' self-assessment as well as for developing an international auditing model. A consortium has been established involving 14 associated partners from Austria, Croatia, France, Germany, Italy, Poland, Portugal, Romania, Spain, Sweden, and the United Kingdom, as well as five collaborating partners from Greece, Hungary, Malta, Slovenia, and Turkey. The project has been established in three steps: 1) Design of a survey about the use of quality tools in a wide sample of European hospitals; 2) Development of quality criteria and quality indicators by the project experts. The main fields considered have been organizational structures, clinical procedures, and outcomes; and 3) Elaboration of an evaluation system to test the quality indicators in 11 European hospitals. Two types of training have been designed and performed: one concerns the development of quality criteria and quality indicators, whereas another is focused on how to use evaluation tools. Following this methodology, the project has so far identified 131 quality criteria and developed 31 quality indicators. Currently, the quality indicators are being tested in 11 selected hospitals.

First global forum on education on organ donation and transplantation for schools.

The Transplantation Society, in collaboration with the Canadian Society of Transplantation, organized a forum on education on ODT for schools. The forum included participants from around the world, school boards, and representatives from different religions. Participants presented on their countries' experience in the area of education on ODT. Working groups discussed about technologies for education, principles for sharing of resources globally, and relationships between education, and health authorities and non-governmental organizations. The forum concluded with a discussion about how to best help existing programs and those wishing to start educational programs on ODT.

Living donor psychosocial assesment/follow-up practices in the partners' countries of the ELIPSY project.

BACKGROUND: Living donor (LD) transplantation has increased recently, but psychosocial aspects of living donation have not been well characterized, as risk factors for the donors. ELIPSY is a project confunded by EAHC, seeking to develop a common methodology for all EU countries for LD assessment/follow-up in the psychosocial sphere (www.eulivingdonor.eu). OBJECTIVE: To evaluate current psychosocial LD assessment/follow-up practices among European centers for key aspects and differences between kidney and liver programs. METHODS: Within a timeline of 30 months, this phase of the project sought to identify current LD psychosocial assessment/follow-up practices. The final survey concerned two versions focused on the kidney and on liver transplant program. The survey took place in ELIPSY partner centers under their own responsibility. Each of the centers sent the survey to other ones performing LD in their country. Partners in the EULID project includes ones in the United Kingdom, Poland, and Romania. The results were analyzed separately for each program seeking to compare and define differences among them. RESULTS: The survey took place in 10 European countries including 65 centers with LD programs. Positive answers regarding psychosocial assessment/follow-up practices were obtained for 26 (42%) kidney and nine (38%) liver centers. Some centers perform several psychosocial follow-ups but did not explain their tools, whereas the centers that did explain the tools used the same ones for both programs.

International Registry in Organ Donation and Transplantation 2010.

The International Registry in Organ Donation and Transplantation (IRODaT) seeks to support the transplant community by providing up-to-date data on organ donation and transplantation worldwide at three different levels: national, regional, and Hospital. The database provides up-to-date information provided by a network of professionals directly involved in the various stages of the donation and transplantation process. All collected data are made public online, so professionals can use them as descriptive and epidemiological references. The registry provides numbers on donors after brain death, donors after cardiac death, and living donors, as well as on specific organ transplantation activities related to the three types of organ donation. A subregistry on tissue and cell donation has been made available as well. All numbers are continuously checked, updated, and validated and, when needed, responsible representatives are contacted for the required statistics. Data on organ donation and transplantation from 2009 and 2010 have been collected from 63 countries. The information reveals a remarkable increase in the donation rate in some countries such as Croatia, Italy, Slovenia, Czech Republic, Germany, Hungary, Australia, Luxemburg, Poland, Brazil, Singapore, Iran, Saudi Arabia, Venezuela, Romania, Bulgaria, Mexico, Russia, and Argentina. IRODaT provides data concerning the organ donation and transplantation activities for the general public and professionals around the world. National and comparative statistics generated on an international basis can be provided that is of extreme value to scientific programs and social and governmental bodies because they can support different initiatives of current practices in organ and tissue donation in any country or region of the world.

The PIERDUB project: International Project on Education and Research in Donation at University of Barcelona: training university students about donation and transplantation.

INTRODUCTION: Donation and transplantation is an accepted therapeutic option when organ failure or tissue replacements are needed to save or improve the quality of life. However, in most medical schools there is no specific training for it, thus disregarding the key role of university students for the future success of the process. OBJECTIVES: Knowledge diffusion about the donation procedure to clarify doubts and stimulate positive attitudes toward donation. Training university students in the donation and transplantation process. Research about the previous donation knowledge and the impact in donation indexes. METHODS: Three different phases have been designed: (1) Training the University of Barcelona Health Sciences School students; (2) Training the Health Sciences School students in other faculties of Catalonia, Spain, and International; and (3) research. RESULTS: Since 2005, we have offered yearly an Optional Credits Course to medical students with duration of 45 hours, and two Donation days opened to health sciences students. Since 2007, promotional campaigns have been carried out in medicine and other health sciences faculties. Until now, 818 answered surveys have been collected to evaluate previous knowledge among university students. CONCLUSION: Training medical and other health sciences students in the donation process will improve quality of medical education and develop a trainer role for future professionals to help improve donation rates.

EULID project: European living donation and public health.

The choice of transplantation from a living donor offers advantages over a deceased donor. However, it also carries disadvantages related to donor risks in terms of health and safety. Furthermore, there are several controversial ethical aspects to be taken into account. Several national and international institutions and the scientific community have stated standards that have great influence on professional codes and legislations. Living organ donation and transplantation are to some extent regulated by parliamentary acts in most European countries. It is necessary to take a step forward to develop a legal framework to regulate all of these processes to guarantee the quality and to prevent illegal and nonethical practices. It is also necessary to develop and implement living donor protection practices not only in terms of physical health, but also to minimize potential impacts on the psychological, social, and economic spheres. Finally, an additional effort should be made to create a database model with recommendations for registration practices as part of the standardized follow-up care for the living donor. The European Living Donation (EULID) project's (http://www.eulivingdonor.eu/) main objective was to contribute to a European consensus to set standards and recommendations about legal, ethical, and living donor protection practices to guarantee the health and safety of living donors.

Training of health care students and professionals: a pivotal element in the process of optimal organ donation awareness and professionalization.

OBJECTIVE: Successes in organ donation and transplantation programs are directly evidence-based education. Transplant Procurement Management (TPM) is an international educational project on organ donation and transplantation. Our purpose was to evaluate the TPM educational project. We compared the data of 17 years of experience, strategies, and methods. MATERIALS AND METHODS: We retrospectively performed a descriptive analysis of all educational activities developed between 1991 and 2008. RESULTS: We identified 7 crucial points. (1) In 1991, TPM was started under the auspices of the University of Barcelona (UB) and the National Spanish Transplant Organization (ONT; national training, face-to-face). (2) In 1994, TPM became international (international advanced training and country-based). (3) Since 1997 in Italy and 2006 in France, national training courses were organized adapting the same methodologies as the advanced international TPM courses. TPM also implemented short (1-3 days) introductory courses worldwide. (4) In 2002, the e-learning platform program was launched to facilitate the education of professionals. (5) In 2005, an international master's degree was created at UB under the Life-Long Learning Institute (IL3). (6) In 2006, the courses were expanded to include pregraduate health science faculties with the International Project on Education and Research in Donation at University of Barcelona (PIERDUB). (7) In 2007, the European-funded European Training Program on Organ Donation (ETPOD) project was started. Currently, TPM offers face-to-face, e-learning, and blended international courses. As of 2008, TPM has trained 6498 professionals in 89 countries on 5 continents. CONCLUSIONS: TPM has impacted positively on the various essential levels in the process of organ donation and transplantation, with lifelong follow-up and an international network through the capacity to adapt to specific country needs as well as continuous quality improvement thanks to the collaboration of expert teachers and consultants.

European quality system for tissue banking.

AIM: The aims of this project were to analyze the factors that influence quality and safety of tissues for transplantation and to develop the method to ensure standards of quality and safety in relation to tissue banking as demanded by European Directive 2004/23/EC and its technical annexes. It is organized in 4 Working Groups, the objectives of each one being focused in a specific area. STANDARDS: The Guide of Recommendations for Tissue Banking is structured into 4 parts: (1) quality systems that apply to tissue banking and general quality system requirements, (2) regulatory framework in Europe, (3) standards available, and (4) recommendations of the fundamental quality and safety keypoints. REGISTRY: This Working Group handled design of a multinational musculoskeletal tissue registry prototype. TRAINING: This Working Group handled design and validation of a specialized training model structured into online and face-to-face courses. The model was improved with suggestions from students, and 100% certification was obtained. AUDIT: The Guide for Auditing Tissue Establishments provides guidance for auditors, a self-assessment questionnaire, and an audit report form. The effectiveness and sustainability of the outputs were assessed. Both guides are useful for experienced tissue establishments and auditors and also for professionals that are starting in the field. The registry prototype proves it is possible to exchange tissues between establishments throughout Europe. The training model has been effective in educating staff and means having professionals with excellent expertise. Member states could adapt/adopt it. The guides should be updated periodically and perhaps a European organization should take responsibility for this and even create a body of auditors.

IRODaT: the International Online Registry for Organ Donation and Transplantation 2007.

OBJECTIVE: IRODaT, an international registry for organ donation and transplantation, presents preliminary data reports on global trends on a regular basis and at various times of the year. The purpose of this report was not only to present statistics, but also to make organ donation effectiveness rates a useful tool to reveal similarities between various countries on an international level. MATERIALS AND METHODS: The IRODaT database produced this report for 2007 thanks to early reporting performed by professionals in coordination and transplant services from 49 countries. The countries were grouped as follows: countries with >200 total donors countries with 50 to 200 donors, and countries with <50 donors. RESULTS: The percentages of deceased and living donors according to the total number of donors from the 49 countries showed that countries performing >200 effective donation procedures yearly in 2007 showed a clear positive trend when compared for number of living donors, donors per million inhabitants, and number of transplantable organs per donor. CONCLUSIONS: The results obtained through this new presentation of the IRODaT provide a quick, clear, and illustrative view of organ donation activity in various countries.

Attitude of health professionals toward cadaveric tissue donation.

INTRODUCTION: A positive attitude toward organ donation would be expected among health professionals from transplant centers with active donor activities. However, acceptance and knowledge about cadaveric tissue donation has been insufficiently studied. OBJECTIVE: The objective of this study was to analyze the knowledge and attitude of health professionals toward cadaveric tissue donation. METHODS: An anonymous survey composed of 23 questions was given to health professionals from 2 university hospitals with donation experience. Sociodemographic and professional characteristics were described to analyze knowledge and acceptance of cadaveric tissue donation. RESULTS: Among 600 distributed questionnaires we collected 514 completely answered surveys. Gender distribution was 399 females/115 males of ages ranging from 18-65 years, namely 18-28 years, 27%; 29-39 years, 31%; 40-50 years, 32%; and 51-65 years, 10%. Among the sample, 31% of health professionals had never been in contact with a transplant recipient. In this study 99.4% had knowledge about cadaveric organ donation compare with 89.7% about tissue donation. The knowledge about various types of tissue donation was as follows: eye, 96%; musculoskeletal, 87%; skin, 72%, and cardiovascular, 67%. In the sample, 93% and 92% accepted the opportunity to receive an organ or tissue transplantation, respectively. The acceptance of a tissue varied according to the type: cardiovascular, 93%; ocular, 94%; skin, 89%; and musculoskeletal, 87%. Participant acceptance of a relative's tissue donation was 74%, refusal was 22%, and with doubts was 4%. CONCLUSIONS: Insufficient knowledge about cadaveric tissue was demonstrated among health professionals more exposed to the donation process. These results highlighted the importance of health professional's education to facilitate public information about organ and tissue donation.

Design and validation of a specialized training model for tissue bank personnel as a result of the European Quality System for Tissue Banking (EQSTB) project.

The main objective of European Quality System for Tissue Banking (EQSTB) project was to analyze throughout different working areas the factors that may influence the final tissue quality and safety for transplantation, providing greater benefit to recipients. Fifteen national organizations and tissue establishments from 12 European countries took part in this project. The Sanco-EQSTB project was organized in four Working Groups. The objectives of each was focused on a specific area. The Standards Working Group analyzed different standards or guides used in various European tissue banks as a quality and safety system. The Registry Working Group created a Tissue Registry through a multinational European network database. The Education Working Group created a specialized training model for tissue bank personnel. The Audit Working Group created an European model of Auditing for tissue establishments. The aim of this article was to describe the activities of Working Group 3 in designing and validating a specialized training model among tissue bank personnel that could become the approved education system recommended by European Union members.

Telephone consent in tissue donation: effectiveness and efficiency in postmortem tissue generation.

UNLABELLED: One reason for the loss of donors is the impossibility to contact family members for an interview. We sought to determine the effectiveness [(donors/total deaths) x 100] and efficiency [(donors/potential donors) x 100] of the telephone interview to obtain tissue for transplant purposes. METHODS: A prospective, comparative cross-sectional study was performed on the personal and telephone interviews with family members during the tissue donation application process from January 1, 2004 to December 31, 2005. RESULTS: Of the 3625 deaths hospital registered, we obtained 770 potential donors (21%). On 65% of occasions (503/770), the interview was held personally; on 29% (222/770), it had to be held over the telephone; and on 6% (45/770), family members could not be located. The refusals by family members over the telephone represented 48% (106/222), and the refusals during personal interviews were 37% (188/503). A positive family answer was obtained over the telephone on 116/431 donations (27%), and in the physical presence of the coordinator for 315/431 donors (73%). The donations obtained over the telephone were only for corneas in 83% (96/116) of cases, and for multiple tissues in 17% (20/116). The donor-generation effectiveness reached 9% in personal interviews and 12% if the telephone interviews were included. The donor generation efficiency reached 43% for personal interviews and 59% when telephone interviews were included. The use of the telephone enabled a 16% increase in tissue generation with a year-on-year increase of 4%. CONCLUSIONS: The telephone has shown itself to be a useful tool for obtaining tissues postmortem.

Liver transplant using donors after unexpected cardiac death: novel preservation protocol and acceptance criteria.

Donors after cardiac death (DCD) suffer irreversible cardiac arrest prior to donation. We describe our liver transplant experience with DCD whose cardiac arrest is unexpected, not following the removal of ventilatory support, whom we maintain with normothermic extracorporeal membrane oxygenation (NECMO). A potential donor goes into cardiac arrest outside the hospital and is brought to the hospital under continuous cardiopulmonary resuscitation (CPR). The donor is declared dead and placed on a cardiocompressor. Femoral vessels are cannulated and connected to cardiopulmonary bypass (CPB) to establish NECMO. Blood parameters and CPB pump flow are monitored throughout NECMO, which is continued until cold preservation. From April 2002 to May 2006, 10 of 40 potential DCD livers were transplanted. Only one graft was lost to primary nonfunction (PNF) and another to hepatic artery thrombosis. Posttransplant hepatic function was good. Certain parameters, such as CPR and NECMO times, hepatic transaminases during NECMO, and donor age, determined the viability of DCD liver grafts and were used to establish criteria for their acceptance. Though considered marginal, unexpected DCD can represent an important source of viable livers for transplant if strict acceptance criteria are employed and they are maintained with NECMO prior to recovery.

Use of quality index in the evaluation of organ procurement and transplant programs in a University Hospital.

AIM: To evaluate organ procurement efficiency at Hospital Clinic of Barcelona (HCP), a University Hospital, in 2000 and 2003 compared with other Catalan, other Spanish, and American (US) results. METHODS: Efficacy rate of the donor procurement was calculated per million population per year (pmp/y). Efficacy rate in kidney, liver, and heart transplantation was calculated also in pmp/y. We evaluated 1-year graft survival. RESULTS: During this period, the average rate number of donors was 49.1 pmp/y in HCP, 38 in Catalonia, 33.4 in Spain, and 21.7 in the United States. The average rate of kidney transplantation was 74 pmp/y in HCP, 55 in Catalonia, 47 in Spain, and 24.6 in the United States. The average rate of liver transplantation was 44.5, 26.6, 23.2, and 18 pmp/y, respectively. The average rate of heart transplantation was 13.3, 8.5, 7.8, and 6.4 pmp/y, respectively. One-year graft survival in HCP was 90.6% for kidney, 89.5% for liver, and 88.2% for heart transplants. DISCUSSION: The results show that organ procurement and transplantation programs in HCP are efficient. The organizational model is based on a hospital transplant coordinator and efficient, well-trained transplant teams.