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.

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.

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.

Potentially serious infections in the aging person: diagnosis, treatment and prevention

Infections in the elderly patient are a challenge, since the classical signs of infection are absent or ill defined. The present paper describes the presentation, diagnosis, clinical manifestations and treatment for a selected group of potential serious infections including influenza, bacterial pneumonia, urinary tract infections as well as infections caused by multiresistant bacteria, like vacomycin-resistant enterococcus and methicillin resistant S. aureus. We conclude with the need for prevention in the older person with the use of vaccines, specifically the influenza and pneumococcal vaccine as well as the prevention of urinary infections. Influenza is a significant cause of morbidity, whose ill effects can be prevented in many older persons with the use of a vaccine. The use in prophylaxis and treatment of antiviral agents like amantadine, rimatadine, and oseltamivir is presented. Bacterial pneumonia is one of the leading causes of death in the USA among the older persons. The emergence of drug resistant Streptococcus pneumoniae leads to the consideration as empiric therapy the newer fluoroquinolones or the use of third or fourth generation cephalosporis. Of importance is the use of pneumococcal vaccine among people age 60 or above. The frequency of urinary tract infections among the elderly is of primary although in many instances important do not require treatment. When infection of the urinary tract is diagnosed, most authors use a fluoroquinolone as empiric theraphy. The emergence of multiresistant bacteria like methicillin resistant S. aureus and or vancomycin resistant enterococci leads to the need to consider new agents like quinipristin-dalfopristin, linezolid and deptomycin in the management of such patients.

Management of urinary tract infections, decubitus ulcer and pneumonia in the aging person

Infections in the older person are common and a significant cause of morbidity and mortality. Infections of the urinary tract, skin and soft tissue infections including decubitus ulcers, antibiotics associated diarrhea and lower respiratory tract infections are particularly important in the elderly because of their frequency. While most initial antibiotic therapy is empiric, its important before treatment to try to document the etiology for better use of antibiotics. Infections of the urinary tract are frequently and potentially serious in the elderly, they must be separated from asymptomatic bacteriuria that requires no therapy. Upper and lower urinary tract infections are frequently caused by aerobic gram negative bacilli and or enterococci. Most authors prefer the use of fluoroquinolones to manage such infections. The elderly with decubitus ulcer presents a problem in management, since these are frequent polymicrobic infections in which anaerobes play an important role. The initial therapy usually involves the combination of a fluoroquinolone plus an antianaerobic agent like clindamycin. C. difficile diarrhea as frequent in nursing home residents as well as the older person with prior antibiotics. The treatment should be with metronidazole and avoid the use of vancomycin. Pneumonias in the elderly can be acquired in the community, the nursing home or during a hospitalization. The etiologic agents that predominate change from S. pneumoniae and atypicals in those from the community to an increase in gram negative pneumonia. The initial treatment as started by most authors as well as guidelines include the use of a new fluoroquinolone like gatifloxacin alone or in combination with a beta-lactamic agent like ceftriaxone. For those infections acquired in the hospital therapy with third or fourth generation cephalosporins, carbapenems, beta-lactams with betalactamase inhibitors alone or in combination with an aminoglucoside and or vancomycin if MRSA is suspected is accepted therapy