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Organ Procurement Organizations (organ + procurement_organization)
Selected AbstractsDonor Screening for Human T-cell Lymphotrophic Virus 1/2: Changing Paradigms for Changing Testing CapacityAMERICAN JOURNAL OF TRANSPLANTATION, Issue 2 2010D. R. Kaul Organ Procurement and Transplant Network (OPTN) policy currently requires the testing of all potential organ donors for human T-cell lymphotrophic virus (HTLV)-1/2. Most Organ Procurement Organizations (OPO) use the Abbott HTLV-I/HTLV-II Enzyme Immunoassay (EIA). This assay will no longer be manufactured after December 31, 2009; the only commercially available FDA-licensed assay will be the Abbott PRISM HTLV-I/II assay which poses many challenges to OPO use for organ donor screening. As a result, screening donors for HTLV-1/2 in a timely manner pretransplant after December 31, 2009 will be challenging. The true incidence of HTLV-1 in United States (U.S.) organ donors is not well described but appears to be low (,0.03,0.5%). HTLV-1 is associated with malignancy and neurological disease; HTLV-2 has not been convincingly associated with disease in humans. Donors that are HTLV-1/2 seropositive are infrequently used despite most results being either false positive or resulting from HTLV-2 infection. There is urgent need to encourage the development of assays, instruments and platforms optimized for organ donors that can be used to screen for transmissible disease in donors; these must have appropriate sensitivity and specificity to identify all infections while minimizing organ loss through false positive testing. [source] Financial Issues Constraining the Use of Pancreata Recovered for Islet Transplantation: A White PaperAMERICAN JOURNAL OF TRANSPLANTATION, Issue 8 2008J. F. Markmann Islet transplantation is a very promising therapy for select patients with type 1 diabetes. Continued clinical investigation is required to define the long-term safety and efficacy outcomes before the procedure will be accepted as a standard of care even for those with the most severe manifestations of diabetes. Threatening successful accomplishment of these and other innovative studies designed to advance the field are the complex financial cost accounting issues that pose undue burden on organ procurement organizations and transplant centers trying to manage the costs of the pancreata from deceased donors needed to isolate islets. Compounding the problem is the recent ruling by CMS regarding ,intent to transplant' (CMS-1543-R Dec. 21, 2006: Allocation of Donor Acquisition Costs Incurred by Organ Procurement Organizations) that does not account for the clinical need to complete the manufacturing process for islets before suitability and transplant intent of the pancreata involved can be determined. We provide a consensus document supported by a diverse group of stakeholders in islet transplantation to suggest actions to address this problem. [source] The Instability of Organ Donation Decisions by Next-of-Kin and Factors That Predict ItAMERICAN JOURNAL OF TRANSPLANTATION, Issue 12 2008J. R. Rodrigue We examined the instability of organ donation decisions made by next-of-kin and factors that predict whether nondonors wish they had consented to donation. Next-of-kin of donor-eligible individuals from one organ procurement organization participated in a semistructured telephone interview. Participants were asked if they would make the same decision if they had to make it again today. Of the 147 next-of-kin donors, 138 (94%) would make the same decision again, 6 (4%) would not consent to donation and 3 (2%) were unsure. Of the 138 next-of-kin nondonors, 89 (64%) would make the same decision again, 37 (27%) would consent to donation and 12 (9%) were unsure. Regret among nondonors was more likely when the next-of-kin had more favorable transplant attitudes (OR = 1.76, CI = 1.15, 2.69), had the first donation discussion with a non-OPO professional (OR = 0.21, CI = 0.13, 0.65), were not told of their loved one's death before this discussion (OR = 0.23, CI = 0.10, 0.50), did not feel they were given enough time to make the decision (OR = 0.25, CI = 0.11, 0.55), had not discussed donation with family members (OR = 0.30, CI = 0.13, 0.72) and had not heard a public service announcement about organ donation (OR = 0.29, CI = 0.13, 0.67). Organ procurement organizations (OPOs) should consider targeting these variables in educational campaigns and donation request approaches. [source] Utility of liver allograft biopsy obtained at procurementLIVER TRANSPLANTATION, Issue 5 2008Irene J. Lo Extended-donor criteria (EDC) liver allografts potentiate the role of procurement biopsy in organ utilization. To expedite allocation, histologic evaluation is routinely performed upon frozen-section (FS) specimens by local pathologists. This descriptive study compares FS reports by local pathologists with permanent-section (PS) evaluation by dedicated hepatopathologists, identifies histologic characteristics underrepresented by FS evaluation, and evaluates the efficacy of a biopsy decision analysis based on organ visualization. Fifty-two liver transplants using EDC allografts evaluated by FS with PS were studied. Pathologic worksheets created by an organ procurement organization were applied in 34 FS. PS analysis included 7 staining procedures for 8 histologic criteria. PS from 56 additional allografts determined not to require donor biopsy were also analyzed. A high correlation was observed between FS and PS. Underestimation of steatosis by FS was associated with allograft dysfunction. Surgical assessment of cholestasis, congestion, and steatosis was accurate whereas inflammation, necrosis, and fibrosis were underestimated in allografts suffering parenchymal injury. In conclusion, the correlation between FS and PS is high, and significant discrepancies are rare. Biopsy is not a prerequisite for EDC utilization but is suggested in hepatitis C, hypernatremia, donation after cardiac death, or multiple EDC indications. Implementation of a universal FS worksheet could standardize histologic reporting and facilitate data collection, allocation, and research. Liver Transpl 2008. © 2008 AASLD. [source] Overview of Guidelines for Establishing a Face Transplant Program: A Work in ProgressAMERICAN JOURNAL OF TRANSPLANTATION, Issue 5 2010M. Siemionow Since 2005, nine face transplants have been performed in four countries: France, the United States (US), China and Spain. These encouraging short-term outcomes, with the longest survivor approaching 5 years, have led to an increased interest in establishing face transplant programs worldwide. Therefore, the purpose of this article is to facilitate the dissemination of relevant details as per our experience in an effort to assist those medical centers interested in establishing a face transplant program. In this article, we address the logistical challenges involved with face transplantation; including essential program requirements, protocol details, face transplant team assembly, project funding, the organ procurement organization and the coroner. It must be emphasized that face transplantation is still experimental and its therapeutic value remains to be validated. All surgical teams pursuing this endeavor must dedicate an attention to detail and should accept a responsibility to publish their outcomes in a transparent manner in order to contribute to the international field. However, due to its inherent complexity, facial transplantation should only be performed by university-affiliated medical institutions capable of orchestrating a specialized multidisciplinary team with a long-term commitment to its success. [source] DonorNet and the Potential Effects on Organ UtilizationAMERICAN JOURNAL OF TRANSPLANTATION, Issue 4p2 2010D. A. Gerber The evolution of communication as donor data flows from organ procurement organization to transplant centers has evolved with the incorporation of DonorNet 2007® into the UNetSM system. The ensuing study looks at DonorNet's impact on this process. We established defined time periods for comparison purposes. The study looked at match number for organ placement and overall organ utilization with a focus on ischemia time and graft outcomes. The results of the study demonstrate no significant change in the median match number of organ placement in liver or kidney transplantation. Changes in discard rates were varied amongst transplanted organs and there were noticeable changes in organ sharing with an increase in local allocation for kidney and liver and an ensuing decrease in regional and national distribution. There were no significant differences in the outcomes of livers and kidneys with low offer numbers compared with those with high offer numbers. Overall the study suggests a modest impact by DonorNet on organ placement and utilization, but a longer term study would need to be done to fully evaluate its impact. [source] Viral Nucleic Acid Testing (NAT) and OPO-Level Disposition of High-Risk Donor OrgansAMERICAN JOURNAL OF TRANSPLANTATION, Issue 3 2009L. M. Kucirka The use of Public Health Service/Centers for Disease Control and Prevention (PHS/CDC) high-risk donor (HRD) organs remains controversial, especially in light of a recent high-profile case of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) transmission. Nucleic acid testing (NAT), while more expensive and time consuming, reduces infectious risk by shortening the period between infection and detectability. The purpose of this study was to characterize HRDs and disposition of their organs by organ procurement organization (OPO), to measure NAT practices by OPO and to examine associations between NAT practices and use of HRD organs. We analyzed 29 950 deceased donors (2574 HRDs) reported to UNOS since July 1, 2004 and May 8, 2008. We then surveyed all OPO clinical directors about their use of NAT, average time to receive NAT results, locations where NAT is performed and percentage of the time NAT results are available for allocation decisions. In total, 51.7% of OPOs always perform HIV NAT, while 24.1% never do. A similar pattern is seen for HCV NAT performance, while the majority (65.6%) never perform HBV NAT. AIDS prevalence in an OPO service area is not associated with NAT practice. OPOs that perform HIV NAT are less likely to export organs outside of their region. The wide variation of current practice and the possibility that NAT would improve organ utilization support consideration for a national policy. [source] The Instability of Organ Donation Decisions by Next-of-Kin and Factors That Predict ItAMERICAN JOURNAL OF TRANSPLANTATION, Issue 12 2008J. R. Rodrigue We examined the instability of organ donation decisions made by next-of-kin and factors that predict whether nondonors wish they had consented to donation. Next-of-kin of donor-eligible individuals from one organ procurement organization participated in a semistructured telephone interview. Participants were asked if they would make the same decision if they had to make it again today. Of the 147 next-of-kin donors, 138 (94%) would make the same decision again, 6 (4%) would not consent to donation and 3 (2%) were unsure. Of the 138 next-of-kin nondonors, 89 (64%) would make the same decision again, 37 (27%) would consent to donation and 12 (9%) were unsure. Regret among nondonors was more likely when the next-of-kin had more favorable transplant attitudes (OR = 1.76, CI = 1.15, 2.69), had the first donation discussion with a non-OPO professional (OR = 0.21, CI = 0.13, 0.65), were not told of their loved one's death before this discussion (OR = 0.23, CI = 0.10, 0.50), did not feel they were given enough time to make the decision (OR = 0.25, CI = 0.11, 0.55), had not discussed donation with family members (OR = 0.30, CI = 0.13, 0.72) and had not heard a public service announcement about organ donation (OR = 0.29, CI = 0.13, 0.67). Organ procurement organizations (OPOs) should consider targeting these variables in educational campaigns and donation request approaches. [source] The Nondirected Living Donor Program: A Model for Cooperative Donation, Recovery and Allocation of Living Donor KidneysAMERICAN JOURNAL OF TRANSPLANTATION, Issue 1 2005James C. Gilbert We describe an altruistic nondirected (ND) and live donor/deceased donor list exchange (LE) donor program administered by an organ procurement organization (OPO) in the Washington, DC area. Screening eliminated 25 donors (17 NE; 8 LE) from the 97 donor applications (62 ND; 35 LE) completed. Twenty-one donors (16 ND; 5 LE) failed to follow through with the psychiatric evaluation, which eliminated 13 donors (9 ND; 4 LE). Two donors dropped out and 12 (9 ND; 3 LE) were medically unsuitable after final clinical evaluation. Twenty donor procedures were performed (10 ND; 10 LE) with four pending (2 ND; 2 LE). This resulted in a modest 3,5% increase in the OPO-procured kidney organ pool. The average cold ischemia time of the grafts not transported between transplant centers was 205 ± 66 min compared with 243 ± 48 min for transported grafts. With no documented adverse outcomes, donors had a hospital stay of length 2.9 days and at home recuperation of 12.3 days. Three- and 6-month creatinines were 1.44 ± 1.36 and 1.68 ± 0.61 for grafts not transported between transplant centers, and 1.6 ± 0.27 and 1.6 ± 0.44 for transported grafts. An OPO-administered altruistic donor program can serve as a model for cooperative donation, recovery and allocation of living donor kidneys. [source] The Importance of Emergency Medicine in Organ Donation: Successful Donation Is More Likely When Potential Donors Are Referred From the Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 9 2009Glen E. Michael MD Abstract Objectives:, This study sought to identify factors that are associated with successful organ retrieval among patients referred to organ procurement services for potential organ donation. Particular attention was paid to the frequency, patient characteristics, and outcomes of patients referred for donation from the emergency department (ED). Methods:, For this retrospective cohort study, data were collected on all solid-organ donor referrals made to a single organ procurement organization serving 78 hospitals over a 45-month period. Data retrieved included patient age, sex, race, referral site (ED vs. inpatient), and mechanism of injury. Outcome of referral (organs retrieved or not) was the primary outcome variable. Pearson chi-square and Student's t-tests were used for bivariate statistical analysis. Multiple logistic regression analysis was used to determine which variables remained associated with organ retrieval after controlling for potential confounders. Results:, A total of 6,886 donor referrals were made in the study population. Of these, 155 were excluded due to incomplete data, leaving 6,731 subjects for analysis. Using bivariate statistical analysis, we found that successful organ retrieval was associated with younger age (donor mean age 40.8 years, 95% confidence interval [CI] = 39.1 to 42.5 vs. nondonor mean age 59.4, 95% CI = 58.9 to 59.9), mechanism of injury (p < 0.001), and referral from the ED (ED 15.5% retrieved, inpatient 5.9%, odds ratio [OR] = 2.92, 95% CI = 2.32 to 3.67). After controlling for potential confounders with multiple logistic regression, referral from the ED remained significantly associated with successful organ retrieval (OR = 1.52, 95% CI = 1.18 to 1.97), as did age (OR = 0.96, 95% CI = 0.96 to 0.97) and mechanism of injury (p < 0.001). On regression analysis, race emerged as a significant predictor of organ retrieval (p < 0.001). Medically suitable patients referred from the ED were significantly more likely on bivariate analysis to have consent for donation granted compared to patients referred from inpatient settings (OR = 1.48, 95% CI = 1.03 to 2.12), but this association was not found to be significant on regression analysis (OR = 1.37, 95% CI = 0.93 to 2.02). Conclusions:, Referral of potential organ donors from the ED is associated with an increased likelihood of successful organ retrieval. The authors conclude that further attention and resources should be directed toward the role of emergency medicine (EM) in the organ procurement process, owing to the relatively high likelihood of successful organ retrieval among patients referred from the ED. [source] Cold ischaemia time added to kidneys can be minimized by completing the final cross-match before organs are taken from the operating roomCLINICAL TRANSPLANTATION, Issue 2003Christopher F Bryan Abstract:,Purpose: Minimizing the amount of cold ischaemia time (CIT) added to cadaveric kidneys before their transplantation is an important goal since longer CIT is associated with worse long-term graft outcome. Our organ procurement organization (OPO) and HLA laboratories have taken the approach of performing the histocompatibility testing, including the final cross-match, as early in the donor process as possible. Methods: The data in this study were collected from all consecutive final cross-matches done for cadaveric kidney (n = 113) and simultaneous pancreas + kidney (SPK) (n = 25) transplants done with organs recovered from donors in the Midwest Transplant Network OPO from 1 January 2001 to 9 May 2002. We evaluated the time the final cross-match was completed from when the kidneys from that donor were taken from the operating room (OR) and compared that time with CIT. Results: For kidney transplants, 72% of the final cross-matches were complete before the kidneys were taken from the OR. The CIT of that group (10.4 ± 3.8 h) was significantly lower than that of the group of kidney transplant patients whose final cross-match was done after the kidneys were taken from the OR (15.5 ± 5.8 h) (P < 0.001). Similarly, for SPK transplants, 88% of the final cross-matches were completed before the organs left the OR and the CIT of that group (10.2 ± 3.4 h) was less than in the group whose final cross-match was done after the organs left the OR (14.3 ± 4.8 h) (P > 0.1). Conclusions: These data show that the practice of completing the final cross-match as early in the donor process as possible helps to minimize the amount of cold ischaemia time added to the kidneys and pancreata before transplantation. That should reduce the detrimental influence that longer CIT has on short- and long-term function in kidney as well as SPK transplantation. [source] MELD,Moving steadily towards equality, equity, and fairnessLIVER TRANSPLANTATION, Issue 5 2005James Neuberger Background and aims: A consensus has been reached that liver donor allocation should be based primarily on liver disease severity and that waiting time should not be a major determining factor. Our aim was to assess the capability of the Model for End-Stage Liver Disease (MELD) score to correctly rank potential liver recipients according to their severity of liver disease and mortality risk on the OPTN liver waiting list. Methods: The MELD model predicts liver disease severity based on serum creatinine, serum total bilirubin, and INR and has been shown to be useful in predicting mortality in patients with compensated and decompensated cirrhosis. In this study, we prospectively applied the MELD score to estimate 3-month mortality to 3437 adult liver transplant candidates with chronic liver disease who were added to the OPTN waiting list at 2A or 2B status between November, 1999, and December, 2001. Results: In this study cohort with chronic liver disease, 412 (12%) died during the 3-month follow-up period. Waiting list mortality increased directly in proportion to the listing MELD score. Patients having a MELD score <9 experienced a 1.9% mortality, whereas patients having a MELD score > or =40 had a mortality rate of 71.3%. Using the c-statistic with 3-month mortality as the end point, the area under the receiver operating characteristic (ROC) curve for the MELD score was 0.83 compared with 0.76 for the Child-Turcotte-Pugh (CTP) score (P < 0.001). Conclusions: These data suggest that the MELD score is able to accurately predict 3-month mortality among patients with chronic liver disease on the liver waiting list and can be applied for allocation of donor livers.(Gastroenterology 2003;124:91,96.) Context: The Model for Endstage Liver Disease (MELD) score serves as the basis for the distribution of deceased-donor (DD) livers and was developed in response to "the final rule" mandate, whose stated principle is to allocate livers according to a patient's medical need, with less emphasis on keeping organs in the local procurement area. However, in selected areas of the United States, organs are kept in organ procurement organizations (OPOs) with small waiting lists and transplanted into less-sick patients instead of being allocated to sicker patients in nearby transplant centers in OPOs with large waiting lists. Objective: To determine whether there is a difference in MELD scores for liver transplant recipients receiving transplants in small vs large OPOs. Design and setting: Retrospective review of the US Scientific Registry of Transplant Recipients between February 28, 2002, and March 31, 2003. Transplant recipients (N = 4798) had end-stage liver disease and received DD livers. Main outcome measures: MELD score distribution (range, 6,40), graft survival, and patient survival for liver transplant recipients in small (<100) and large (> or =100 on the waiting list) OPOs. RESULTS: The distribution of MELD scores was the same in large and small OPOs; 92% had a MELD score of 18 or less, 7% had a MELD score between 19 and 24, and only 2% of listed patients had a MELD score higher than 24 (P = .85). The proportion of patients receiving transplants in small OPOs and with a MELD score higher than 24 was significantly lower than that in large OPOs (19% vs 49%; P<.001). Patient survival rates at 1 year after transplantation for small OPOs (86.4%) and large OPOs (86.6%) were not statistically different (P = .59), and neither were graft survival rates in small OPOs (80.1%) and large OPOs (81.3%) (P = .80). Conclusions: There is a significant disparity in MELD scores in liver transplant recipients in small vs large OPOs; fewer transplant recipients in small OPOs have severe liver disease (MELD score >24). This disparity does not reflect the stated goals of the current allocation policy, which is to distribute livers according to a patient's medical need, with less emphasis on keeping organs in the local procurement area. (JAMA 2004;291:1871,1874.) [source] Optimizing the use of donated cadaver livers: Analysis and policy development to increase the application of split-liver transplantationLIVER TRANSPLANTATION, Issue 10 2002Jean C. Emond MD The American Society of Transplant Surgeons and the American Society of Transplantation jointly sponsored a conference in Crystal City, Virginia, on March 28th and 29th, 2001, to explore mechanisms for maximizing the cadaver-organ donor pool. Participants from transplantation medicine, surgery, organ procurement organizations, the general public, and government convened to address expanding utilization of each organ type. The committee assigned to review liver organ utilization identified multiple practices that could expand the potential donor pool including non,heart beating donors, marginal grafts, efficient allocation of cadaver organs, and wider application of split-liver transplantation. This article details the data reviewed by the liver committee and their recommendations on policy development for the expanded application of split-liver transplantation. [source] Redrawing organ distribution boundaries: Results of a computer-simulated analysis for liver transplantationLIVER TRANSPLANTATION, Issue 8 2002Richard B. Freeman MD For several years, the Organ Procurement and Transplantation Network/United Network for Organ Sharing (UNOS) Liver and Intestinal Transplantation Committee has been examining effects of changes and proposed changes to the liver allocation system. The Institute of Medicine recently recommended that the size of liver distribution units be increased to improve the organ distribution system. Methods to achieve this and the potential impact on patients and transplant centers of such a change are evaluated in this study. In hypothetical scenarios, we combined geographically contiguous organ procurement organizations (OPOs) in seven different configurations to increase the size of liver distribution units to cover populations greater than 9 million persons. Using the UNOS Liver Allocation Model (ULAM), we examined the effect of 17 different organ allocation sequences in these proposed realignments and compared them with those predicted by ULAM for the current liver distribution system by using the following primary outcome variables: number of primary liver transplantations performed, total number of deaths, and total number of life-years saved. Every proposed new liver distribution unit plan resulted in fewer primary transplantations. Many policies increased the total number of deaths and reduced total life-years saved compared with the current system. Most of the proposed plans reduced interregional variation compared with the current plan, but no one plan consistently reduced variation for all outcome variables, and all reductions in variations were relatively small. All new liver distribution unit plans led to significant shifts in the number of transplantations performed in individual OPOs compared with the current system. The ULAM predicts that changing liver distribution units to larger geographic areas has little positive impact on overall results of liver transplantation in the United States compared with the current plan. Enlarging liver distribution units likely will result in significant shifts in organs across current OPO boundaries, which will have a significant impact on the activity of many transplant centers. [source] ASTS Recommended Practice Guidelines for Controlled Donation after Cardiac Death Organ Procurement and TransplantationAMERICAN JOURNAL OF TRANSPLANTATION, Issue 9 2009D. J. Reich The American Society of Transplant Surgeons (ASTS) champions efforts to increase organ donation. Controlled donation after cardiac death (DCD) offers the family and the patient with a hopeless prognosis the option to donate when brain death criteria will not be met. Although DCD is increasing, this endeavor is still in the midst of development. DCD protocols, recovery techniques and organ acceptance criteria vary among organ procurement organizations and transplant centers. Growing enthusiasm for DCD has been tempered by the decreased yield of transplantable organs and less favorable posttransplant outcomes compared with donation after brain death. Logistics and ethics relevant to DCD engender discussion and debate among lay and medical communities. Regulatory oversight of the mandate to increase DCD and a recent lawsuit involving professional behavior during an attempted DCD have fueled scrutiny of this activity. Within this setting, the ASTS Council sought best-practice guidelines for controlled DCD organ donation and transplantation. The proposed guidelines are evidence based when possible. They cover many aspects of DCD kidney, liver and pancreas transplantation, including donor characteristics, consent, withdrawal of ventilatory support, operative technique, ischemia times, machine perfusion, recipient considerations and biliary issues. DCD organ transplantation involves unique challenges that these recommendations seek to address. [source] Improving the Recruitment and Retention of Organ Procurement Coordinators: A Survey StudyAMERICAN JOURNAL OF TRANSPLANTATION, Issue 6 2009J. Kress Organ procurement coordinators (coordinators) employed by organ procurement organizations (OPOs) are critical to the success of organ donation. However, their high turnover rates may threaten the success of organ donation. This cross-sectional study examined employment satisfaction and factors contributing to job turnover among 326 coordinators representing 52 of 58 OPOs (90%) who completed an online survey. Most (93%) respondents reported high levels of job satisfaction, although 26% reported considering leaving their OPO, and 61% perceived a high turnover rate at their OPO. Considerations of leaving the OPO were most likely to emerge at 2 years of employment. To secure coordinator job satisfaction, it is essential that prospective coordinators be adequately prepared and informed about negative as well as positive aspects of this line of work. In hiring, OPOs should recruit more proactively, using their staff as contacts, and seek experience in critical care, intensive care, or other on-call work. To retain satisfied employees, OPOs should offer more education and advancement opportunities and focus on such issues as call and hours, rather than salary per se. OPOs should consider a variety of alternative pay structures, particularly separate on-call pay, whether or not coordinators are actually called into service. [source] Organ Procurement Organization Compliance with 21 CFR 1271: A Challenge for Allogeneic Pancreatic Islet Cell Transplantation ProgramsAMERICAN JOURNAL OF TRANSPLANTATION, Issue 6 2009J. L. Winters In order to protect tissue recipients, the Food and Drug Administration drafted Title 21, Section 1271 of the Code of Federal Regulations 1271 (21 CFR 1271) to address infectious disease risk. These regulations apply to tissues but not vascularized organs. Pancreatic islet cells are regulated under 21 CFR 1271. These regulations require qualification of suppliers of critical materials and services with regard to 21 CFR 1271 compliance. As part of supplier qualification, all organ procurement organizations (OPOs) in the United States were sent a questionnaire covering the key components of these regulations. Of the 57 OPOs, 29 (51%) were in compliance based upon survey results. Twelve (21%) were not compliant in one or more areas. All indicated plans to become compliant. The remaining 15 (27%) either failed or refused to complete the survey, some indicating 21 CFR 1271 did not apply to OPOs. Using 2006 data, OPOs compliant with 21 CFR 1271 recovered 50% of the organs procured in the United States. These findings represent a challenge for allogeneic islet cell transplant programs whose raw material must comply with 21 CFR 1271. OPOs should work toward understanding and complying with 21 CFR 1271. Regulatory agencies should work toward enhancing safety of the pancreas supply by facilitating compliance through harmonization of requirements. [source] Provider Utilization of High-Risk Donor Organs and Nucleic Acid Testing: Results of Two National SurveysAMERICAN JOURNAL OF TRANSPLANTATION, Issue 5 2009L. M. Kucirka Fears of infectious transmission from CDC high-risk donors (HRDs) remain a significant disincentive, and the potential for human immunodeficiency virus/hepatitis C virus (HIV/HCV) nucleic acid testing (NAT) to allay these fears remains unstudied. We hypothesized that NAT, which narrows the window period between infection and detectability compared to the standard ELISA, might lead to increased provider willingness to use HRDs. Between January and April 2008, we performed two national surveys: one of current NAT practice among organ procurement organizations (OPOs); a second of HRD use among transplant surgeons. Surgeons who reported accepting 10% or more offers for a given HRD behavior and organ type were classified as ,high utilizers' of that subgroup. We built hierarchical models to examine associations between OPO NAT performance and provider utilization. Providers who ranked medical risks of HIV or HCV as important disincentives to HRD use had significantly lower odds of being high utilizers (HIV odds ratio 0.22, HCV odds ratio 0.41, p < 0.005). Furthermore, both HIV and HCV NAT performance were associated with significantly higher odds of being high utilizers (HIV odds ratio 1.58, HCV 2.69, p < 0.005). The demonstrated associations between OPO NAT performance and high provider utilization of HRDs should be considered in the ongoing debate about NAT in transplantation. [source] Financial Issues Constraining the Use of Pancreata Recovered for Islet Transplantation: A White PaperAMERICAN JOURNAL OF TRANSPLANTATION, Issue 8 2008J. F. Markmann Islet transplantation is a very promising therapy for select patients with type 1 diabetes. Continued clinical investigation is required to define the long-term safety and efficacy outcomes before the procedure will be accepted as a standard of care even for those with the most severe manifestations of diabetes. Threatening successful accomplishment of these and other innovative studies designed to advance the field are the complex financial cost accounting issues that pose undue burden on organ procurement organizations and transplant centers trying to manage the costs of the pancreata from deceased donors needed to isolate islets. Compounding the problem is the recent ruling by CMS regarding ,intent to transplant' (CMS-1543-R Dec. 21, 2006: Allocation of Donor Acquisition Costs Incurred by Organ Procurement Organizations) that does not account for the clinical need to complete the manufacturing process for islets before suitability and transplant intent of the pancreata involved can be determined. We provide a consensus document supported by a diverse group of stakeholders in islet transplantation to suggest actions to address this problem. [source] SRTR Program-Specific Reports on Outcomes: A Guide for the New ReaderAMERICAN JOURNAL OF TRANSPLANTATION, Issue 4p2 2008D. M. Dickinson Differences in outcomes indeed exist among transplant programs and organ procurement organizations (OPO). A growing set of tools are available from the Scientific Registry of Transplant Recipients (SRTR) to measure and assess these outcomes in the different phases of the transplant process. These tools are not intended to compare two individual programs, rather to help identify programs whose practices may need further scrutiny, to be either avoided, corrected or emulated. To understand which differences in outcomes might be due to underlying differences in populations served and which might be due to differences in treatment, it is important to compare outcomes to ,risk-adjusted' expected values. Further, it is important to recognize and assess the role that random chance may play in these outcomes by considering the p-value or confidence interval of each estimate. We present the reader with a basic explanation of these tools and their interpretation in the context of reading the SRTR Program-Specific Reports. We describe the intended audience of these reports, including patients, monitoring and process improvement bodies, payers and others such as the media. Use of these statistics in a way that reflects a basic understanding of these concepts and their limitations is beneficial for all audiences. [source] CMS oversight, OPOs and transplant centers and the law of unintended consequencesCLINICAL TRANSPLANTATION, Issue 6 2009Richard J. Howard Abstract:, The Health Resources and Services Administration launched collaboratives with the goals of increasing donation rates, increasing the number of organs transplanted, eliminating deaths on the waiting list and improving outcomes. The Center for Medicare and Medicaid Services (CMS) recently published requirements for organ procurement organizations (OPOs) and transplant centers. Failure to meet CMS performance measures could result in OPOs losing their service area or transplant centers losing their CMS certification. CMS uses analyses by the Scientific Registry of Transplant Recipients (SRTR) to evaluate a transplant center's performance based on risk-adjusted outcomes. However, CMS also uses a more liberal (one-sided) statistical test rendering more centers likely to qualify as low performing. Furthermore, the SRTR model does not incorporate some important patient variables in its statistical model which may result in biased determinations of quality of care. Cumulatively, there is much unexplained variation for transplant outcomes as suggested by the low predictive ability of survival models compared to other disease contexts. OPOs and transplant centers are unlikely to quietly accept their elimination. They may take certain steps that can result in exclusion of candidates who might otherwise benefit from transplantation and/or result in fewer transplants through restricted use of organs thought to carry higher risk of failure. CMS should join with transplant organizations to ensure that the goals of the collaborative are not inhibited by their performance measures. [source] |