Despite clinical and laboratory screening of potential donors for transmissible disease, unexpected transmission of disease from donor to recipient remains an inherent risk of organ transplantation. The Disease Transmission Advisory Committee (DTAC) was created to review and classify reports of potential disease transmission and use this information to inform national policy and improve patient safety. From January 1, 2008 to December 31, 2017, the DTAC received 2185 reports; 335 (15%) were classified as a proven/probable donor transmission event. Infections were transmitted most commonly (67%), followed by malignancies (29%), and other disease processes (6%). Forty‐six percent of recipients receiving organs from a donor that transmitted disease to at least 1 recipient developed a donor‐derived disease (DDD). Sixty‐seven percent of recipients developed symptoms of DDD within 30 days of transplantation, and all bacterial infections were recognized within 45 days. Graft loss or death occurred in about one third of recipients with DDD, with higher rates associated with malignancy transmission and parasitic and fungal diseases. Unexpected DDD was rare, occurring in 0.18% of all transplant recipients. These findings will help focus future efforts to recognize and prevent DDD.
Analysis and dissemination of transplant patient safety data are essential to understanding key issues facing the transplant community and fostering a “culture of safety.” The Organ Procurement and Transplantation Network's (OPTN) Operations and Safety Committee de‐identified safety situations reported through several mechanisms, including the OPTN's online patient safety portal, through which the number of reported cases has risen sharply. From 2012 to 2013, 438 events were received through either the online portal or other reporting pathways, and about half were self‐reports. Communication breakdowns (22.8%) and testing issues (16.0%) were the most common types. Events included preventable errors that led to organ discard as well as near misses. Among events reported by Organ Procurement Organization (OPOs), half came from just 10 of the 58 institutions, while half of events reported by transplant centers came from just 21 of 250 institutions. Thirteen (23%) OPOs and 155 (62%) transplant centers reported no events, suggesting substantial underreporting of safety‐related errors to the national database. This is the first comprehensive, published report of the OPTN's safety efforts. Our goals are to raise awareness of safety data recently reported to the OPTN, encourage additional reporting, and spur systems improvements to mitigate future risk.
The opioid epidemic has resulted in a potential increase in donors in the testing window period for hepatitis C virus (HCV). We analyzed HCV reports to the Disease Transmission Advisory Committee (DTAC) between 2008 and 2016 to estimate the risk of HCV transmission. In 15 of 95 (16%) reports, at least one recipient developed proven/probable donor-derived HCV resulting in 32 infected recipients. Seven transmissions occurred during the nucleic acid testing (NAT) window period; four occurred during serological window period. The other four transmission occurred due to human error (3) and false-negative serology (1). All seronegative-exposed liver and lung recipients contracted HCV; 18/21 (86%) kidney and 3/4 (75%) heart recipients developed HCV. Four transmitting donors died of intravenous drug overdose, three in 2016 and one in 2012. Among donors with a history of intravenous drug use (IVDU), drug intoxication as a mechanism of death, or increased risk status, and negative screening HCV testing, the risk of transmission to a recipient was about 1 in 1000. The overall risk of transmitting HCV from NAT-negative donors with IVDU is low and consistent with modeling data. This information may be helpful to clinicians counseling potential recipients offered these organs.
All 179 reports to the OPTN of potential renal cell carcinoma (RCC) transmission from 1/1/2008 through 12/31/2016 were reviewed. Cases were divided into those with donor tumor known or suspected at time of transplant (N = 147 donors), and those in which tumor was initially found after transplant (N = 32). We sought to understand the risk of transplanting either the affected kidney, the contralateral kidney or non‐renal organs from donors with a suspected/confirmed unilateral RCC. In the case of RCC found prior to transplant, transplantation of 21 kidneys following excision of tumor, 47 contralateral kidneys and 198 non‐renal organs was performed. No cases of RCC transmission were documented in this population. An additional six cases of live donor kidney transplantation involving resection of RCC were reported, also without transmission. Six of 9 other recipients in whom the diagnosis of RCC became available after implantation underwent allograft nephrectomy and 3 received tumor resection. No recurrent RCC was documented. Given the low rate of transmission and available treatment options, consideration should be given to judicious use of organs from donors with small solitary RCC.
These findings demonstrate that alternative definitions of underinsurance yield dramatically different underinsurance rates. Further, even when yielding similar rates, alternative definitions may identify substantially different sets of children. The likelihood of being underinsured has a strong association with low-income status and pervasiveness of the child's special health care needs. Understanding these factors and their implications will be important when planning accessible and comprehensive health plans and care systems for CSHCN.
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