Reported effects of the Scientific Registry of Transplant Recipients 5-tier rating system on US transplant centers: results of a national survey.

In the United States, the Scientific Registry of Transplant Recipients (SRTR) provides publicly available quality report cards. These reports have historically rated transplant programs using a 3-tier system. In 2016, the SRTR temporarily transitioned to a 5-tier system, which classified more programs as under-performing. As part of a larger survey about transplant quality metrics, we surveyed members of the American Society of Transplant Surgeons and American Society of Transplantation (N = 280 respondents) on transplant center experiences with patient and payer responses to the 5-tier SRTR ratings. Over half of respondents (n = 137, 52.1%) reported ≥1 negative effect of the new 5-tier ranking system, including losing patients, losing insurers, increased concern among patients, and increased concern among referring providers. Few respondents (n = 35, 13.7%) reported any positive effects of the 5-tier ranking system. Lower SRTR-reported scores on the 5-tier scale were associated with increased risk of reporting at least one negative effect in a logistic model (P < 0.01). The change to a more granular rating system provoked an immediate response in the transplant community that may have long-term implications for transplant hospital finances and patient options for transplantation.

Parental refusal of vaccination and transplantation listing decisions: a nationwide survey.

Many professional societies and research studies recommend complete vaccination before pediatric solid organ transplantation. Nevertheless, incompletely vaccinated children often receive transplants. As the number of parents refusing to vaccinate children for nonmedical reasons increases, pediatric transplantation programs face difficult listing decisions. Given the importance of psychosocial criteria in listing decisions, this study explores how parental refusal of vaccination affects those listing decisions. Surveys were emailed to individuals at 195 pediatric solid organ transplantation programs in the United States, with a 71% response rate. Forty-four respondents (39%) reported that their programs have had cases involving parental refusal of vaccination. In response to hypothetical scenarios, 93 respondents (82%) would list a child not vaccinated for medical reasons, whereas only 54 respondents (47%) would list a child whose parents refused vaccination. Only five respondents (4%) reported that their programs had written policies regarding parental refusal of vaccination. These data reveal inconsistencies across pediatric transplantation programs regarding how parental refusal of vaccination affects listing decisions and raise the issue of whether and how the reason for incomplete vaccination should be factored into listing decisions. We recommend further discussion and the development of written guidelines to unify programs' assessments of incompletely vaccinated pediatric transplantation candidates.

Trekking new ground: overcoming medical and social impediments for extended criteria liver transplant recipients.

KEY POINTS: 1. There is an increasing recognition that previously marginal candidates for liver transplantation can receive therapies that allow transplant to take place. 2. Coronary artery disease is an increasing co-morbidity in liver transplant candidates. 3. Physio-social issues require written guidelines and patient advocates. 4. Methadone maintenance therapy per se is not a contra-indication to liver transplantation.

Temporal bone bank: complying with European Union directives on human tissue and cells.

BACKGROUND: Availability of allograft tympano-ossicular systems (ATOS) provides unique reconstructive capabilities, allowing more radical removal of middle ear pathology. To provide ATOS, the University of Antwerp Temporal Bone Bank (UATB) was established in 1988. ATOS use was stopped in many countries because of safety issues concerning human tissue transplantation. Our objective was to maintain an ATOS tissue bank complying with European Union (EU) directives on human tissues and cells. METHODS: The guidelines of the Belgian Superior Health Council, including EU directive requirements, were rigorously applied to UATB infrastructure, workflow protocols and activity. Workflow protocols were updated and an internal audit was performed to check and improve consistency with established quality systems and changing legislations. The Belgian Federal Agency of Medicines and Health Products performed an inspection to examine compliance with national legislatives and EU directives on human tissues and cells. A sample of important procedures was meticulously examined in its workflow setting next to assessment of the infrastructure and personnel. RESULTS: Results are reported on infrastructure, personnel, administrative workflow, procurement, preparation, processing, distribution, internal audit and inspection by the competent authority. Donors procured: 2006, 93 (45.1%); 2007, 64 (20.6%); 2008, 56 (13.1%); 2009, 79 (6.9%). The UATB was approved by the Minister of Health without critical or important shortcomings. The Ministry accords registration each time for 2 years. CONCLUSIONS: An ATOS tissue bank complying with EU regulations on human allografts is feasible and critical to assure that the patient receives tissue, which is safe, individually checked and prepared in a suitable environment.

Hematologist and transplant physicians: How and where to meet for the best of sickle cell disease patients?

Despite huge progress in the fields of newborn screening, encapsulated bacterial infection prophylaxis, immunization, and supportive care in general, people suffering from sickle cell anemia still continue to have a shorter life expectancy and a poorer quality of life due to painful vaso-occlusive events and strokes during childhood, and later, cardiac, pulmonary, and renal injuries, including in Western and high-income countries. From the 2000s, allogeneic stem cell transplantation for severe sickle cell disease from a sibling donor provided the best results-overall as well as disease-free survival-never obtained for any other disease. Nevertheless, this only curative option is proposed to few patient numbers, including in Western countries with high-level medical equipment development, with discrepancies between (i) patients and family, (ii) physicians and care centers dedicated to sickle cell disease, and (iii) hematopoietic stem cell transplant teams. Due to these discrepancies and in order to provide the same quality of discussion and treatment choice for every sickle cell disease patient, we developed a National French multidisciplinary pluri-annual meeting dedicated to sickle cell disease patients and transplantation. We report here our experience of such a meeting.

Rapid Modification of Workflows and Fellow Staffing at a Single Transplant Center to Address the COVID-19 Crisis.

BACKGROUND: Although hospital systems have largely halted elective surgical practices in preparing their response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, transplantation remains an essential and lifesaving surgical practice. To continue transplantation while protecting immunocompromised patients and health care workers, significant restructuring of normal patient care practice habits is required. METHODS: This is a nonrandomized, descriptive study of the abdominal transplant program at 1 academic center (University of California, San Francisco) and the programmatic changes undertaken to safely continue transplantations. Patient transfers, fellow use, and patient discharge education were identified as key areas requiring significant reorganization. RESULTS: The University of California, San Francisco abdominal transplant program took an early and aggressive approach to restructuring inpatient workflows and health care worker staffing. The authors formalized a coronavirus disease 2019 (COVID-19) transfer system to address patients in need of services at their institution while minimizing the risk of SARS-CoV-2 in their transplant ward and used technological approaches to provide virtual telehealth where possible. They also modified their transplant fellow staffing and responsibilities to develop an adequate backup system in case of potential exposures. CONCLUSION: Every transplant program is unique, and an individualized plan to adapt and modify standard clinical practices will be required to continue providing essential transplantation services. The authors' experience highlights areas of attention specific to transplant programs and may provide generalizable solutions to support continued transplantation in the COVID-19 era.

Innovations in the assessment of transplant center performance: implications for quality improvement.

Continuous quality improvement efforts have become a central focus of leading health care organizations. The transplant community has been a pioneer in periodic review of clinical outcomes to ensure the optimal use of limited donor organs. Through data collected from the Organ Procurement and Transplantation Network (OPTN) and analyzed by the Scientific Registry of Transplant Recipients (SRTR), transplantation professionals have intermittent access to specific, accurate and clinically relevant data that provides information to improve transplantation. Statistical process control techniques, including cumulative sum charts (CUSUM), are designed to provide continuous, real-time assessment of clinical outcomes. Through the use of currently collected data, CUSUMs can be constructed that provide risk-adjusted program-specific data to inform quality improvement programs. When retrospectively compared to currently available data reporting, the CUSUM method was found to detect clinically significant changes in center performance more rapidly, which has the potential to inform center leadership and enhance quality improvement efforts.

Formal policies and special informed consent are associated with higher provider utilization of CDC high-risk donor organs.

A new United Network for Organ Sharing (UNOS) policy mandates special informed consent (SIC) before transplanting organs from donors classified by the Public Health Service/Center for Disease Control (PHS/CDC) as high-risk donors (HRDs); however, concerns remain that this policy may cause suboptimal organ utilization. Currently, consent and disclosure policy is determined by individual centers or surgeons; as such, little is known about current practices. The goals of this study were to quantify consent and disclosure practices for HRDs in the United States, identify factors associated with SIC use and analyze associations between SIC use and HRD organ utilization. We surveyed 422 transplant surgeons about their use of HRD organs and their associated consent and disclosure practices. In total, 52.7% of surgeons use SIC, but there is a high variation in use within centers, between centers and by donor behavior. A defined HRD policy at a transplant center is strongly associated with SIC use at that center (OR = 4.68, p < 0.001 by multivariate hierarchical logistic regression). SIC use is associated with higher utilization of HRD livers (OR 3.37), and a trend toward higher utilization of HRD kidneys (OR 1.74) and pancreata (OR 1.28). We believe our findings support a formalized national policy and suggest that this policy will not result in decreased utilization.

Ethical issues of organ transplantation in Chinese community: perspectives of health professionals, legal professionals, and religious experts in Taiwan and mainland china.

OBJECTIVE: This study aimed to compare the perspectives of leading ethical issues related to organ transplantation as perceived by health professionals (HP), legal professionals (LP), and religious experts (RE) from Taiwan (TW) and Mainland China (MC). MATERIALS AND METHODS: A purposive sample including TW's organ transplant health professionals (OTHP), LP, and RE and MC's HP was obtained in this qualitative research. Data were analyzed by content analysis. RESULTS: A total of 127 subjects participated in this project (n = 119 in TW, 8 in MC). They were HP (n = 92), RE (n = 25 TW), and LP (n = 10 TW). Seven ethical dilemmas were reported: (1) difficulties in touching the hearts of the public (HP 100%, LP 100%, RE 100%); (2) challenges in helping donors and their families (HP 96%, RE 80%, LP 50%); (3) competence and availability of HP (HP 93%, RE 72%, LP 50%); (4) questionable social farewell (HP 92%, RE 20%, LP 100%); (5) questionable legitimacy of prisoners' motivations (LP 90%, RE 64%, HP 60%); (6) worry about public discrimination (LP 90%, HP 50%, RE 20%); and (7) challenges to families in taking care of the recipients (HP 87%, LP 70%, RE 52%). CONCLUSIONS: To provide holistic care, HP need to invite RE to provide spiritual support for the donors of cadaveric organs, recipients, and their families. Reliable LP can help them to complete the sophisticated legal procedures. With help from this triangulated collaborative team, the value of organ transplantation will be appreciated by the public.

The European protocol on organ transplant: key issues.

What is interesting in the philosophy of the European Protocol is the search of a balanced position which acknowledges the medical progress brought by organ transplants and considers the necessity to ensure that human dignity and individual freedom are respected. However, the principles adopted for such regulations at the European level leave on some major issues a great margin of appreciation to the domestic legislation. This is particularly true in areas such as defining death or consenting to organ transplants including the situation of minors and the role of the family. A last point should also be stressed regarding the European protocol: its lack of efficiency concerning a neglected but important issue: organ trafficking.

From Experimental Technique to Clinical Practice: Which Pathway in Transplant Surgery?

The question of whether a medical procedure is to be considered experimental or routine practice has enormous practical implications. In transplant surgery, as compared with pharmacologic clinical trials, the transition from experimental procedure to normal care is far from clear cut. Clinical trials comprise 4 well-established phases of evaluation going from phase I, aimed at assessing safety and identifying side effects in a few healthy volunteers, to phase IV, which involves entire populations and is aimed at long-term postmarketing surveillance. In transplant surgery, technical progress and experimentation follow more atypical and individual routes. As compared with pharmacologic research, the decision about "routine practice readiness" of a surgical procedure does not rely on a standardized formal act but rather on experts' capacity to find a consensus based on best practices and on ad-hoc criteria as well. Independent assessment by a panel of experts and oversight by an institutional review board are key to facilitating meaningful protection of transplant recipients and allowing the research to go forward. The framework of the human subjects protection regulations should also consider the transplant of organs that have previously been part of a research project.

Organ trafficking and transplant tourism: a commentary on the global realities.

The extent of organ sales from commercial living donors (CLDs) or vendors has now become evident. At the Second Global Consultation on Human Transplantation of the World Health Organization's (WHO) in March 2007, it was estimated that organ trafficking accounts for 5-10% of the kidney transplants performed annually throughout the world. Patients with sufficient resources in need of organs may travel from one country to another to purchase a kidney (or liver) mainly from a poor person. Transplant centers in 'destination' countries have been well known to encourage the sale of organs to 'tourist' recipients from the 'client' countries.

Evaluation of research products released during a national project funded by the Italian Ministry of Health.

Evaluation of research products released during activities that have received public funds should be a mandatory practice. In this study, we evaluated the research products released during the research program "Innovative Strategies to Expand Cadaveric Donor Pool for Liver Transplantation" (SITF Project), funded by the Italian Ministry of Health. The SITF Project prefigured the participation of Italian transplantation centers with more advanced experience in the field of liver transplantation. The research products released during the SITF Project were evaluated according to Guidelines for Research Evaluation of the Committee for Evaluation of Research (CIVR) from the Italian Ministry of Education, University and Research. Thus, we considered as the research products released during the SITF Project the number of articles published in English language in peer-reviewed scientific journals by each operative unit (OU), as returned by PubMed. The articles were included on the basis of relationship with the research lines of the SITF Project and availability of the impact factor (IF) calculated by Thomson Scientific for each journal. Following these criteria, 62 research products were released during the executive phase of the SITF Project (January 1, 2004-December 31, 2005). All research products were original articles, with no reviews or letters. The articles were published in 10 different scientific journals (mean IF, 2.64+/-1.74). Spearman's rank test found a weak negative correlation between journal IF and number of published articles (r= -.2919; P= .413). Although the OU involved in the coordination of the SITF Project released a relatively high number of articles (n=8; IF, 0.923+/-0.352), several other OUs obtained better results for number of articles (9-11) and/or IF (3.071+/-2.248 or 2.959+/-1.779). In projects that benefit from public funds, the potential negative impact of coordination activities to scientific production should be adequately considered.

Hygienic safety of reusable tap water filters (Germlyser) with an operating time of 4 or 8 weeks in a haematological oncology transplantation unit.

BACKGROUND: Microbial safe tap water is crucial for the safety of immunosuppressed patients. METHODS: To evaluate the suitability of new, reusable point-of-use filters (Germlyser, Aquafree GmbH, Hamburg, Germany), three variations of a reusable filter with the same filter principle but with different outlets (with and without silver) and inner surface coating of the filter encasements (with and without nano-crystalline silver) were tested. The filter efficacy was monitored over 1, 4 and 8 weeks operating time in a haematological oncology transplantation unit equipped with 18 water outlets (12 taps, 6 showers). RESULTS: The filtered water fulfilled the requirements of absence of pathogens over time. From 348 samples, 8 samples (2.3%) exceeded 100 cfu/ml (no sample > or = 500 cfu/ml). As no reprocessed filter exhibited 100% filter efficacy in the final quality control after each reprocessing, these contaminations could be explained by retrograde contamination during use. CONCLUSION: As a consequence of the study, the manufacturer recommends changing filters after 4 weeks in high risk areas and after 8 weeks in moderate infectious risk areas, together with routine weekly alcohol-based surface disinfection and additionally in case of visible contamination. The filter efficacy of the 3 filters types did not differ significantly regarding total bacterial counts. Manual reprocessing proved to be insufficient. Using a validated reprocessing in a washer/disinfector with alkaline, acid treatment and thermic disinfection, the filters were effectively reprocessable and now provide tap water meeting the German drinking water regulations as well as the WHO guidelines, including absence of pathogens.

Transplanting the Body: Preliminary Ethical Considerations.

A dissociated area of medical research warrants bioethical consideration: a proposed transplantation of a donor's entire body, except head, to a patient with a fatal degenerative disease. The seeming improbability of such an operation can only underscore the need for thorough bioethical assessment: Not assessing a case of such potential ethical import, by showing neglect instead of facing the issue, can only compound the ethical predicament, perhaps eroding public trust in ethical medicine. This article discusses the historical background of full-body transplantation, documents the seriousness of its current pursuit, and builds an argument for why prima facie this type of transplant is bioethically distinct. Certainly, this examination can only be preliminary, indicating what should be a wide and vigorous discussion among practitioners and ethicists. It concludes with practical suggestions for how the medical and bioethics community may proceed with ethical assessment.