Organ Procurement Agencies Research Articles

Investigation of a Donor-derived Carbapenamase-producing Carbapenem-resistant Enterobacterales Hospital Outbreak

Carbapenamase-producing carbapenem-resistant Enterobacterales (CP-CRE) is an urgent public health threat for healthcare facilities. Solid organ transplant (SOT) recipients carry an increased risk for CRE infection and colonization due to prolonged exposures to antimicrobials, healthcare facilities and immunosuppression. CRE infection in SOT patients is associated with an increase in morbidity and mortality. Here, we describe a hospital outbreak investigation of three cases of New Delhi metallo-beta-lactamase (NDM) - CRE that led to novel findings with implications for further interdisciplinary investigations. An NDM-CRE infection in a critically-ill patient was identified during passive surveillance and prompted an investigation. Previous CP-CRE passive surveillance cases were reviewed. Rectal screening was performed for potentially exposed patients. 403 rectal swabs were tested for carbapenemase genes in active surveillance. Patients identified to have a new NDM-CRE isolate on active or passive surveillance were considered cases and underwent in-depth chart review including possible patient-to-patient exposures, hospital locations, procedures, devices, and consultations. NDM-CRE isolates were sent to the Minnesota Department of Health (MDH) for whole genome sequencing (WGS) to assess relatedness. Five NDM-CRE cases were identified, with all isolates harboring blaNDM including three NDM-Klebsiella pneumoniae (NDM-KP) cases (Figure 1). The first NDM-KP case, patient 1, developed mediastinal infection following lung transplantation. Review of United Network for Organ Sharing revealed that respiratory specimens from patient 1’s donor grew NDM-KP and a bronchial wash at the time of transplant yielded NDM-KP. The second NDM-KP case (patient 3) developed ventilator-associated pneumonia and was found to have used sequentially the same ventilator as patient 1. The third NDM-KP case (patient 4) was detected via rectal swab in active surveillance and shared wound care personnel in common with patients 1 and 3 (Figure 2). WGS demonstrated two single nucleotide polymorphisms (SNP) among all three isolates, strongly suggesting relatedness (Figure 3). Best practices for infection prevention were reviewed with wound care personnel. To date, no further NDM-KP isolates have been identified. Investigation was facilitated by in-depth chart review and WGS via the Central Region Antimicrobial Resistance Laboratory Network at MDH. Detection of the NDM-KP from a lung donor specimen appears genetically linked to clinical isolates in other patients, raising the possibility of a donor-derived hospital outbreak. This investigation is the first to describe a donor-derived NDM outbreak in a healthcare facility. Communication between organ procurement agencies, transplant centers, and infection prevention must be optimized to prevent CRE-associated morbidity in SOT receipts and CRE hospital outbreaks.

49 Organ Donation Potential in Cases of Fatal Gunshot Wounds to the Head: Tools for Timely Screening in the Emergency Department

Gunshot wounds to the head (GSWH) have a high mortality rate and account for over a third of deaths due to head injury. Here we hypothesize that out-of-hospital vital signs may be useful tools in preliminary identification of organ donation potential when a patient presents to the ED with a fatal GSWH. Retrospective analysis was performed on data from an urban level 1 trauma center’s trauma database. All adult patients with out-of-hospital vital signs on-scene who presented to the ED before expiring due to a fatal GSWH between 1/1/2012 and 12/31/2018 were included. Characteristics of organ donors vs non-donors were analyzed, including injury severity score/abbreviated injury scale-head (ISS/AIS), on-scene Glasgow Coma Score (GCS), on-scene systolic blood pressure (SBP), on-scene respiratory rate (RR), and location of death. For non-normally distributed data, differences between groups were assessed with Wilcoxon Rank Sum Test. Differences for categorical variables were assessed using either Pearson's chi-squared test or Fisher's Exact Test. Significance noted when p < 0.05. Of 208 subjects meeting inclusion criteria, organ donation requests were made in 36 (17.3%) cases and 22 (10.6%) patients donated organs. Neither mean ISS nor AIS-head differed significantly between donors and non-donors (ISS: 4.5 vs 4.7 p=0.3761. AIS-head: 33.7 vs 27.3 p=0.0647) (Table 1). Donors had significantly higher mean on-scene GCS (5.1 vs 3.9 p=0.0016), SBP (129.3 vs 82.1 p=0.0028) and RR (20.5 vs 10.7 p=0.0001) than non-donors (Fig. 1A, B, C). While there was no significant difference in mean GCS at the ED (3.6 vs 3.5 p=0.4093), donors had a significantly larger decrease in mean GCS vs non-donors (-1.4 vs -0.6 p=0.0018) between on-scene and hospital assessment (Fig 1A). At the ED, donors had significantly higher mean SBP than non-donors (114.1 vs 82.7 p=0.0323) (Fig 1B). More donors than non-donors died in the ICU (90.9% vs 45.7%); 9.1% of donors and 45.7% of non-donors died in the OR; no donor died in the ED compared to 52.2% of non-donors; one non-donor (0.5%) died on the floor. Differences in location of death were significant (p < 0.0001) (Table 1). Out-of-hospital GCS, SBP, and RR values were all significantly higher in donors than non-donors. Donors also had significantly higher mean SBP at the ED and a larger decline in GCS between on-scene and the ED compared to non-donors. Nearly half of the study group, all non-donors, died in the ED. Out-of-hospital vitals and status changes en route to the ED may be of use in early identification of potential donors, allowing timely referral to organ procurement agencies, increasing donor opportunity and organ donation. No extra time or resources would be required to collect these metrics, as they are already assessed during emergent resuscitation and management of patients. Timely identification of donor potential may allow fatally wounded patients who expire in the ED the chance to become donors.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Management of Pediatric Kidney Transplant Patients During the COVID-19 Pandemic: Guidance From the Canadian Society of Transplantation Pediatric Group.

Purpose of the program:To provide guidance on the management of pediatric kidney transplant patients during the COVID-19 pandemic.Sources of information:Program-specific documents, preexisting, and related to COVID-19; documents from provincial, national, and international kidney transplant societies/agencies and organ procurement agencies; national and international webinars, including webinars that we hosted for input and feedback; with additional information from formal and informal review of published academic literature.Methods:Challenges in the care of pediatric kidney transplant patients during the COVID-19 pandemic were highlighted within the Canadian Society of Transplantation (CST) Pediatric Group. It identified pediatric kidney transplant nephrologists (including a pediatric nephrologist ethicist) across the country and formed a workgroup. The initial guidance document was drafted and members of the workgroup reviewed and discussed all suggestions in detail via e-mail and virtual meetings. Disagreements were resolved by consensus. The document was reviewed by the CST Kidney Transplant Working Group, by the Canadian Society of Nephrology (CSN) COVID-19 Rapid Response Team (RRT), and an infectious disease expert. The suggestions were presented at an interactive webinar sponsored by CSN in collaboration with the CST and Canadian Association of Pediatric Nephrologists (CAPN), and attended by pediatric kidney health care professionals for further peer input. Final revisions were made based on feedback received. CJKHD editors reviewed the parallel process peer review and edited the manuscript for clarity.Key findings:We identified 8 key areas of pediatric kidney transplant care that may be affected by the COVID-19 pandemic: (1) transplant activity, (2) outpatient clinic activity, (3) monitoring, (4) multidisciplinary care, (5) medications (immunosuppression and others), (6) patient/family education/support, (7) school and employment, and (8) management of pediatric kidney transplant patients who are COVID-19 positive. We make specific suggestions for each of these areas.Limitations:A full systematic review of available literature was not undertaken for the sake of expediency in development of this guideline. There is a paucity of literature to support evidence-based recommendations at this time. Instead, these guidelines were formulated based on expert opinion derived from available knowledge/experience and are subject to the biases associated with this level of evidence. The parallel review process that was created to expedite the publication of this work may not be as robust as standard arms’ length peer review processes.Implications:These recommendations are meant to serve as a guide to pediatric kidney transplant directors, clinicians, and administrators for providing the best patient care in the context of limited resources while protecting patients and health care providers wherever possible by limiting exposure to COVID-19. We recognize that recommendations may not be applicable to all provincial/local health authority practices and that they may not be delivered to all patients given the time and resource constraints affecting the individual provincial/local health jurisdiction.

Transforming Care for Patients and Providers: Perspective from Nonprofit Providers.

On July 10th, 2019, we watched the President sign Executive Order #13879, “Advancing American Kidney Health” (AAKH) ([1][1]). The Department of Health and Human Services (HHS) Secretary Alex Azar stated: “Decades of paying for sickness and procedures in kidney care, rather than paying for

Pregnancy and Brain Death: Lack of Guidance in U.S. Hospital Policies

Objective The death of Marlise Muñoz, a pregnant woman who suffered an anoxic brain injury in November 2013, highlights the social, ethical, legal, and medical controversies associated with brain death in pregnancy. We sought to evaluate whether institutions in the United States have policies in place for situations in which a pregnant woman is declared brain dead. Study Design Institutional brain-death protocols from hospitals in the United States were obtained in cooperation with local and regional organ procurement agencies. Each protocol was reviewed to determine if and how it addressed brain death in pregnancy. Results We reviewed 317 unique brain-death protocols. In eight protocols (2.5%), it was noted that a pregnant patient could not be evaluated for brain death if the fetus could be preserved. Of the protocols that permitted brain-death evaluation, 289 (93.8%) did not include guidance about fetal management after maternal brain death and 305 (99%) did not indicate who was responsible for making decisions for the fetus. Conclusion Very few institutional brain-death policies address the issue of pregnancy. The creation of guidelines on management of the social and ethical challenges associated with brain death in pregnancy may be helpful.

The necessity of strengthening the cooperation between tissue banks and organ transplant organizations at national, regional, and international levels

The donation of tissues and organs increases significantly when tissue banks and organ transplant organizations work together in the procurement of organs and tissues at donor sources (hospitals, coroners system, organ procurement agencies, and funeral homes, among others). To achieve this important goal, national competent health authorities should considered the establishment of a mechanism that promote the widest possible cooperation between tissue banks and organ transplant organizations with hospitals, research medical institutions, universities, and other medical institutions and facilities. One of the issues that can facilitate this cooperation is the establishment of a coding and traceability system that could identify all tissues and organs used in transplant activities carried out in any country. The promotion of national, regional, and international cooperation between tissue banks and organ transplant organizations would enable the sharing of relevant information that could be important for medical practice and scientific studies carried out by many countries, particularly for those countries with a weak health care system.

A critical analysis of liver allograft utilization from the US deceased donor pool

A critical analysis of liver allograft utilization from the US deceased donor pool

ETHICAL DEBATE OVER ORGAN DONATION IN THE CONTEXT OF BRAIN DEATH

This study investigated what information about brain death was available from Google searches for five major religions. A substantial body of supporting research examining online behaviors shows that information seekers use Google as their preferred search engine and usually limit their search to entries on the first page. For each of the five religions in this study, Google listings reveal ethical controversy about organ donation in the context of brain death. These results suggest that family members who go online to find information about organ donation in the context of brain death would find information about ethical controversy in the first page of Google listings. Organ procurement agencies claim that all major world religions approve of organ donation and do not address the ethical controversy about organ donation in the context of brain death that is readily available online.

Emerging & Rare Fungal Infections in Solid Organ Transplant Recipients

Emerging & Rare Fungal Infections in Solid Organ Transplant Recipients

Prognostic Value of MELD Score and Donor Quality in Liver Transplantation: Implications for the Donor Recipient Match

The model for End-stage Liver Disease (MELD) has been adopted by the Organ Procurement and Transplantation Network (OPTN) in 2002 as the standard priority rule for the liver transplantation waiting list. We retrospectively calculated the pretransplant MELD scores of 226 consecutive adult grafts. We did not correct for hepatocellular carcinoma comorbidity or for the etiology of liver disease. Cases were categorized according to the MELD score: class I, MELD scores between 6 and 14 (low MELD, n = 116); class II, MELD score between 15 and 24 (intermediate MELD, n = 78); class III, MELD score between 25 and 42 (high MELD, n = 32). All patients were transplanted using deceased donors. Grafts were categorized also according to donor quality (standard donor vs nonstandard donor). Sorting into categories was performed before transplant by officers of the Central-South Italian Transplant Organization overregional organ procurement agencies, namely OCST. Differences in Kaplan-Meier graft survivals (GS) between low MELD class and high MELD class were statistically significant ( P < .01). Among standard donors, the 6-month GS were 83%, 94%, and 63% for the low, intermediate, and high MELD subset, respectively, differences that did not reach statistical significance. Among nonstandard donors, the 6-month GS were 77%, 71%, and 38% for the low, intermediate, and high MELD classes, respectively. Differences between low MELD class and intermediate MELD class and between low MELD class and high MELD class were statistically significant ( P < .01). We strongly suggest that the utilization of nonstandard organs should be avoided for patients with high MELD scores.

End-of-Life Decision Making, Organ Donation, and Critical Care Nurses

End-of-Life Decision Making, Organ Donation, and Critical Care Nurses

The Global Alliance for Transplantation

In 2002, The Transplantation Society proposed the creation of a Global Alliance for Transplantation, with the purpose of reducing the existing disparity regarding transplantation activities across the globe. This alliance should include major international scientific societies, international governmental organizations, and pharmaceutical companies. Consultations with each of these parties have taken place during the past 18 months and three Strategic Programs have been initiated: (1) the collection of information on transplantation; (2) the expansion of education in transplantation; and (3) the development of professional guidelines for organ donation and transplantation.

Ethics and regulation in organ procurement research.

This article explores the role of ethics and regulation in human research conducted by organ procurement agencies; basic ethical principles for human research are outlined. Organ procurement agencies are not required to observe federal regulations; however, voluntary adherence will ensure that procurement research is conducted according to current standards of ethical practice. Although most organ procurement research will qualify for exempt status, this determination should be made by an institutional review board. Even if studies qualify for exempt status, there is a moral presumption that informed consent should be sought, unless certain narrow conditions for waiver of consent are satisfied. Finally, when future research utilizing organ procurement records is anticipated, procurement coordinators should provide sufficiently detailed information to families about such plans to permit their advance informed consent to research activities.

Ethics and regulation in organ procurement research

This article explores the role of ethics and regulation in human research conducted by organ procurement agencies; basic ethical principles for human research are outlined. Organ procurement agencies are not required to observe federal regulations; however, voluntary adherence will ensure that procurement research is conducted according to current standards of ethical practice. Although most organ procurement research will qualify for exempt status, this determination should be made by an institutional review board. Even if studies qualify for exempt status, there is a moral presumption that informed consent should be sought, unless certain narrow conditions for waiver of consent are satisfied. Finally, when future research utilizing organ procurement records is anticipated, procurement coordinators should provide sufficiently detailed information to families about such plans to permit their advance informed consent to research activities.

Tissue donation: what does it mean to families?

Previous research has described families' responses and experiences with the donation process; however, little attention has been paid to families linked to tissue banks that have no affiliation with hospitals or organ procurement agencies. To assess the impact of approaches made to families who consented to tissue donation with the Donor Tissue Bank of Victoria, Australia, and to examine how this information could be used to improve the existing service. An evaluation questionnaire was developed and consisted of 15 questions. The questionnaire was part of a structured follow-up service and was given only to 339 families who consented to donation. Families who are approached about tissue donation are contacted within 24 hours of their family member's death. They are coping with the sudden unexpected death of a family member and have little knowledge of tissue donation or the donor tissue bank. Fifty-eight percent of participants completed the questionnaire. The data were quantitatively and qualitatively examined. The skills and procedures utilized by the transplant coordinators are affirmed by the results, and respondents appear to find contact with the donor tissue bank positive at a terrible time in their lives. Approaches to families must be made sensitively and sufficient information must be given to enable decision making.

Tissue Donation: What Does it Mean to Families?

Context Previous research has described families' responses and experiences with the donation process; however, little attention has been paid to families linked to tissue banks that have no affiliation with hospitals or organ procurement agencies. Objective To assess the impact of approaches made to families who consented to tissue donation with the Donor Tissue Bank of Victoria, Australia, and to examine how this information could be used to improve the existing service. Design An evaluation questionnaire was developed and consisted of 15 questions. The questionnaire was part of a structured follow-up service and was given only to 339 families who consented to donation. Setting and Participants Families who are approached about tissue donation are contacted within 24 hours of their family member's death. They are coping with the sudden unexpected death of a family member and have little knowledge of tissue donation or the donor tissue bank. Main Outcome Measures Fifty-eight percent of participants completed the questionnaire. The data were quantitatively and qualitatively examined. Results The skills and procedures utilized by the transplant coordinators are affirmed by the results, and respondents appear to find contact with the donor tissue bank positive at a terrible time in their lives. Approaches to families must be made sensitively and sufficient information must be given to enable decision making.

Transplant legislation: ethical and practical issues in liver allocation--The case of Switzerland.

Ethical and practical issues relating to liver allocation have been discussed in many countries. Several governments, including the United States, have attempted over the past few years to impose new legislation, which has resulted in virulent debates among individual centers, organ procurement agencies, states, and various groups of interest. This report discusses the current ongoing legislative process in Switzerland. In 1999, the people of Switzerland voted to develop transplant legislation. This reflected the need to regulate poorly defined practices to adapt to the rapid progress within the field of transplantation. The main issue facing the Swiss transplant community is whether new legislation will allow medical evolution in organ allocation criteria without creating regulations that may become outdated with time. In addition, public debate has been shown to have a negative impact on organ donation, thus emphasizing an ever-present penury in cadaveric allografts. This article discusses these issues within the context of liver transplantation in Switzerland and also raises the uniform ethical and practical constraints placed on the medical transplant community in the face of an organ shortage.

Organ donor maintenance and procurement

Donor shortage remains a critical problem in transplantation. Good management of available donors is a high priority. The majority of donors are heart beating, brain dead cadaveric donors from whom multiple organs are procured for transplantation. Most of these cadaveric donors have significant physiologic defects, which are magnified after brain death. Expeditious correction of these defects is vital to good function of the organs after transplantation. Optimal donor management can also impact long term graft function. The other critical factor in organ procurement is a technically sound retrieval of donor organs. Anatomical variations and abnormalities must be diligently identified while performing an expeditious retrieval of the organs. Most retrieval procedures are performed on an emergency basis with teams from different transplant centers working together in unfamiliar operating conditions. Anesthetic management of the cadaveric donor is important since the brain dead donors are frequently unstable from a cardiovascular standpoint. Donor procurement is a highly complex procedure that is coordinated exquisitely by organ procurement agencies. Donor procurement is a cooperative endeavor, which contributes to the health of the recipients. The donor families view organ donation as the only good thing that comes out of an otherwise tragic incidence.

Expanding the donor pool for liver transplantation.

Because of the growing shortage of donor organs, physicians and organ procurement agencies are expanding the donor pool through three mechanisms. The first mechanism is to increase the number of patients (and their families) who give consent for organ donation and thus extend the number of cadaveric livers. The second mechanism is that marginal livers, previously considered unacceptable for transplantation, are now being successfully transplanted. The third way to expand the donor pool is through advances in medical practice such as living-donor liver transplantation and split-liver transplantation.

LVAD BRIDGE TO HEART TRANSPLANT THERAPY: EFFECTS ON OUTCOME, WAITING TIME, CENTER VOLUME, AND DONOR RESOURCE ALLOCATION

230 The availability of implantable LVAD's has increased their use while raising concerns of increasing donor shortage, waiting times, and shifting donor resource allocation. We compared transplant outcomes from a 12 month period (10/1/96-9/30/97) of LVAD (HeartMate, TCI, Inc., Woburn, MA) use to a 12 month period prior to acquisition of the LVAD (10/1/95-9/30/96). The HeartMate (IP-1000/VE models) were acquired at the UMich in 9/96. During the earlier period, 3 pts received circulatory support as a bridge to transplant (2 ECMO; 1 Abiomed). During the most recent period, 6 pts received circulatory support prior to transplant (6 HeartMate). All pts receiving LVAD's were in cardiogenic shock supported by 2 or more inotropes with 60% having IABP's (9 pts underwent HeartMate implantation-6 transplanted, 2 awaiting transplant, and 1 death). During the period of LVAD use there was a 65% increase in transplants performed (33 vs. 20). The number of pts transplanted as UNOS status I increased from 20% to 33% (4/20 vs 11/33). Median waiting time for status 1 pts increased from 0.25 to 1.6 months (mean 0.3±0.2 vs 1.9±1.5; p<0.05). Median waiting time for UNOS status II pts increased from 5.9 to 8.1 months (mean 9.8±9.3 vs 9.8±8.0; p=ns). There were no deaths in pts listed and awaiting transplant during the most recent period despite increased waiting time. The median total length of stay (LOS) from pre-transplant admission to post-transplant discharge increased from 21 to 25 days (mean 39±46 vs 44±45; p=ns). Median total LOS for pts transplanted as status I increased from 56 to 78 days (mean 84±83 vs 87±53; p=ns) as a result of increased pre-transplant LOS. Total LOS for pts transplanted as status II remained unchanged (median LOS 19 days; mean 28±25 vs 22±13; p=ns). Median post-transplant LOS for all pts increased from 15 to 17 days (mean 30±14 vs 23±18; p=ns). There was a significant decrease in median post-transplant LOS for pts transplanted as status I (45 vs 14 days; mean 70±84 vs 27±26; p<0.05). The median post-transplant LOS for pts transplanted as status II increased from 13 to 19 days (mean 20±13 vs 21±12 days). Actuarial 1 yr survival (KM) was 75% during the earlier period and 96% during the most recent period. Comparing the initial 6 months of each time period fewer hearts were sent out of our local organ procurement agency (11 vs 15) and more received from outside organ procurement agencies (3 vs 1) during the most recent period. Conclusions: Acquisition of an LVAD was associated with an increased transplant volume, a shift to performing more status I transplants, increased waiting time for both status I and II pts. a reduced post-transplant LOS for pts transplanted as status I, increased utilization of donor organs within our local organ procurement agencies, and increased overall survival. LVAD bridge to transplant therapy impacts favorably on heart transplant outcomes.