| A7 |
Mareri M, Filippetti M, Ghirardini A, Vespasiano F, Ciaccio P, Costa AP (2011)(14)
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To describe the functioning of the EUROCET Portal and the biosurveillance system in Europe. |
Case report. Description of the EUROCET Network, Competent Authorities (CA) and Authorized Tissue Establishments (TEs). |
Description of the EUROCET Network, Competent Authorities (CA) and Authorized Tissue Establishments (TEs). |
There are 33 countries linked to EUROCET and 57 CAs, 3,974 TEs are registered: 1,108 for tissues, 1,480 for hematopoietic progenitor cells and 1,386 for assisted reproduction. |
Based on cooperation with the CAs, EUROCET represents them in the European Network. The Portal contributes to the biosurveillance system in Europe. State members of the EU rely on the web portal and database, which contributes to decision-making based on facts and guidelines. |
Recommendations |
| b1 |
Ali AK (2013)(15)
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To identify and characterize risks and serious AE associated with exposure to BRM (Biologic Response Modifiers) in organ transplant patients in a real-world environment. |
Cross-sectional observational study. Sample: 12,151 AE reports |
Analysis of AE reported to the Adverse Event Reporting System. Adverse events related to drugs used in organ transplant patients were analyzed. |
A total of 12,151 notifications classified as serious events were analyzed. Of these, 6,749 (55%) related to sirolimus; 2,317 (19%) to mycophenolate; 1,067 (9%) to cyclosporine; 841 (7%) to tacrolimus; 725 (6%) related to antithymocyte immunoglobulin and 452 (4%) to others. Types of AE reported: neurotoxicity; hospitalization or longer length of hospital stay; reinterventions; coma; death. |
The use of Biologic Response Modifiers for prophylaxis against transplant rejection is associated with serious AE that can be fatal. Transplant specialists must be cautious when prescribing these drugs to transplant patients and monitor patients’ progress in terms of safety, tolerability, and transplant outcomes during the exposure period. |
Results |
| c3 |
Stewart DE, et al. (2015)(16)
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To describe an AE review process based on root cause analysis in an organ transplant center and its contributions to the improvement of the process. |
Retrospective cross-sectional observational study. Notifications of safety situations in the period from 2012 to 2013, via the online portal or other means of generating reports. |
Transplant-related AE or near miss reported in the period from 2012 to 2013, via the online portal or other forms of reporting were analyzed. |
Between 2012 and 2013, 438 adverse event reports were received through the online portal or other forms of reporting, and about half were self-reports. Communication failure (22.8%) was the most common type of event. Events considered as avoidable errors led to the disposal of organs and near misses. Among events reported by the Organ Procurement Organization (OPOs), half came from just 10 out of 58 institutions, while half of the events reported by centros came from just 21 out of 250 institutions. Thirteen (23%) OPOs and 155 (62%) transplant centers reported no events, suggesting substantial underreporting |
In one year, 438 AE were reported, and 50% of these were self-reports. The most common event was related to communication failure. The study evidences the underreporting of AE. |
Result |
| d2 |
Czerwiński J, Kaliciński P, Danielewicz R (2015)(17)
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To provide an introduction to everyday organ transplant practices from national and European legislative initiatives to monitor and manage SAREs (Serious Adverse Reactions and Events) in order to ensure the quality of organ donation from both deceased and living donors and the safety of donors and recipients in living transplants. |
Prospective, descriptive, cross-sectional observational study. Analysis of 129 reports of AE and AR. |
Analysis of 129 reports of AE and AR from the period between 2012 and 2013, referring to living donors and recipients, from the total of 3,223 transplanted organs. |
In the analyzed period, 3,223 transplants were performed, with 17 serious AE and 112 AR documented (events in 0.5% and reactions in 3.4% of cases). |
The purpose of the SARE registry is to collect and manage occurrences related to living donors and recipients, due to the quality of the donor, the organ and the process of collection and management of the organ until implantation. The SARE monitoring system aims at self-assessment, development and dissemination of information about the potential dangers of organ transplantation. Considering the small number of SARE referred to Poltransplant in 2012 (n = 64) and 2013 (n = 65), during which the monitoring system was fully implemented, the authors indicate there was underreporting. According to the authors, underreporting results from the fear of transplant centers to reveal possible failures. |
Results |
| e6 |
Eguchi S, et al. (2017)(18)
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To describe the donor advocacy program established by Nagasaki University Hospital and launched for living donors of liver, bone marrow, kidney, lung, and other organs. |
Observational qualitative study. Case report. Description of three cases. |
The study describes how the University of Nagasaki Hospital established and implemented a Donor Advocacy Team (DAT): a risk management program for initiation in the event of severe, persistent, or fatal impairment of an organ, tissue, or cell transplant from a living donor. |
The Nagasaki University Hospital has established a risk management system called the DAT and a system of communication and response to local government, mass media, academic transplant societies and the Japan Organ Transplant Network. DAT functions: to provide assistance to donors, their family and the medical staff involved and communicate accurate information to the public without delay; risk management team, composed of physicians and professionals from different areas, such as risk manager, counselor, spokesperson, responsible for legal matters, bioethicist and social worker. |
The study describes the risk management process called DAT and establishes quick and effective communication strategies for professionals and institutions involved in the donation and transplant process and the population. |
Recommendations |
| f5 |
Khorzad R, Montague E, Nannicelli AP, Woods DM, Ladner DP, Brown A, Holl JL (2018)(19)
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To describe an improvement project conducted as part of the United Network for Organ Sharing project. |
Case report. Sample: 42 physicians and staff from 10 organ procurement organizations and two transplant centers in the United States participated in the study. |
An interdisciplinary team conducted a Process Failure Modes and Effects Analysis, laboratory simulations of organ labeling during purchase, and a heuristic evaluation of a labeling software application to inform the design of TransNet, a system that uses barcode on the organ retrieval point. A total of 42 physicians and staff from 10 organ procurement organizations and two transplant centers across the United States participated. Processes covered: key features of the redesigned labeling system include independent, dual input of label information into the software application, a barcode machine on each organ label, and a portable printer for printing labels at the “point of use” |
The new labeling, TransNet, became mandatory since June 2017. The survey conducted with early adopters after one year of use, indicates the process is safer and more efficient. Implications for practice: results of this study suggest that the application of quality planning methods, common in other sectors, when redesigning a health care process, are valuable and revealing, and should be adopted more widely. Future evaluation of the effectiveness of TransNet in reducing security incidents is critical. Process Failure Modes and Effects Analysis revealed 146 potential failures, of which 34 (23%) were associated with a verification step in organ labeling and 56 (38%) had the potential to harm a patient or result in organ loss. The greatest potential for damage failures was underlying low frequency causes (1 in 10,000 or less in 37 failures, 1 in 5000 for 14 failures, and 1 in 2000 for 2 failures). Three failures had causes with a moderate frequency of 1 in 1000. Two were related to the omission of critical information (eg, hepatitis B status, piçamento time that was handwritten and to the outer packaging labels, and one was related to a data entry/transcription error that can occur when entering immunology laboratory results into the donor management software, DonorNet. |
The risks and incidents found refer to sample labeling errors due to unreliable source information and data entry errors during the registration of donors in the electronic OPO system. Study resulted in comprehensive identification of organ labeling risks. The findings indicate that the design of TransNet, a system implemented in OPOs in the United States in 2014, has now become mandatory. |
Process |
| g4 |
Mathur AK, Stemper-Bartkus C, Engholdt K, Thorp A, Dosmann M, Khamash H (2019)(20)
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To describe the AE analysis process based on root cause analysis in an organ transplant center and its contributions to process improvement. |
Retrospective cross-sectional observational study. Sample: analysis of 1,449 transplant procedures |
Analysis of quality improvement domains identified in departmental case reviews at a high-volume transplant center. Specific areas of process improvement vary by stage of treatment: transplant center / pre-transplant / donation: Operative and perioperative care / Post-transplant / donation care. Descriptive statistics from departmental case analyzes performed as of October 26, 2015 May 14, 2018 - AE by area/by organ. |
In 30 months, 1,449 transplant and living donor procedures were analyzed, with a total of 45 deaths and 31 graft losses; 91 notifications: 43 related to kidney transplant; 24 to liver; 10 to pancreas; 6 to heart; 3 to lung; 5 related to the living donor. Seventy-nine action plan items were identified in the improvement domains, including errors in clinical decision making, communication, compliance, documentation, selection, waiting list management, and administrative processes. The average time to review was 83 days and six days to complete the action plan. Clinical decision-making in the pre-transplant phase was identified as an opportunity for improvement in all programs. |
The analysis of reported cases provides a robust approach to the review of transplant AE. The AE review process begins with the occurrence and reporting of an AE, including patient deaths, graft losses, and other patient safety events. This process includes thorough review of the narrative timeline, multidisciplinary discussion, and creation of action plan items aimed at improving processes using quality improvement methods. |
Process |
| h8 |
Cohen J, Ashkenazi T (2019)(21)
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To describe the implementation and use of a centralized medical advisory service (MAS), based on a telephone service (aimed at mapping the safety, quality and standardization of the donation process). |
Prospective, observational, quanti-qualitative study. |
Analysis of a centralized MAS created in 2007 to answer questions from healthcare professionals about organ safety, determination of brain death and donor management. Data collected from 2007 to 2017 included the number and context of consultations and the average number of organs transplanted. |
Sample: 2,826 consultations to the centralized MAS from 2007 to 2017. The context of consultations shows the formulation of protocols related to donor infections and malignancy and difficulties identified regarding the determination of brain death and subsequent implementation of solutions. |
Study describes the implementation and use of a centralized MAS, based on a telephone service. Authors suggest that this model can provide a valuable resource to improve the safety, quality and standardization of the donation process. |
Recommendations |
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