The DTAC News CONTENTS WELCOME. From the OPTN/UNOS Ad Hoc Disease Transmission Advisory Committee

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1 The DTAC News From the OPTN/UNOS Ad Hoc Disease Transmission Advisory Committee FIRST EDITION FEBRUARY, 2010 Welcome to the first edition of the DTAC News. This newsletter is brought to you by the OPTN/UNOS Ad Hoc Disease Transmission Advisory Committee and is meant to be a resource to the transplant community toward avoiding potential donor-derived disease transmission. CONTENTS Welcome OPTN/UNOS Guidance Regarding H1N1 Donor Screening Requirement for HTLV-1/2 Eliminated Reports of Potential TB Transmissions on the Rise Donor Derived Bacterial Transmissions and their Consequences Donor Renal Cell Carcinoma and Organ Transplant How YOU Can Report a Potential Disease Transmission Additional Information WELCOME Welcome to the OPTN/UNOS Ad Hoc Disease Transmission Advisory Committee (DTAC) newsletter. In the upcoming months, this publication will keep you abreast of DTAC s ongoing work. DTAC s charge is broad. Its members consider issues related to the transmission of disease through organ transplantation by examining individual potential disease transmission cases reported to the OPTN in real time in an effort to confirm transmissions where possible. The Committee reviews aggregate data on all reported cases to assess the risk of donor disease transmission in organ transplantation in the U.S. with the goal of providing: education and guidance to the transplant community toward preventing future disease transmission; and input in developing policy to improve the safety of organ donation through the reduction of donor derived transmission events. It may identify disease-transmission related patient safety issues to be addressed, as appropriate, by the OPTN. This premier issue of the newsletter will focus on H1N1, HTLV, TB, bacterial infections, and renal cell carcinoma. Please feel free to contact us with thoughts, opinions, or ideas for topics in future editions. We hope to make this newsletter as helpful to the transplant community as possible. It is hoped that this publication will be used as a resource. With this new line of communication, the DTAC hopes that organ utilization will increase and become even safer. Lewis Teperman, MD Editor

2 OPTN/UNOS GUIDANCE REGARDING H1N1 The DTAC, in consultation with members of the Liver and Intestinal Organ Transplantation and Thoracic Organ Transplantation Committees, developed a guidance document to provide OPOs and transplant centers information and additional online resources to help navigate through this year s flu season. H1N1 continues to raise concerns throughout the transplant community. To date, two cases of potential transmission from donor to recipient have been reported to the OPTN; neither has been documented to result in transmission of influenza from the donor to a recipient. To learn more about questions to consider when evaluation potential organ donors as well as some general recommendations, please visit: ELIMINATION OF HTLV-1/2 DONOR SCREENING REQUIREMENTS Effective November 23, 2009, screening potential organ donors for HTLV-1/2 is no longer required by policy. The OPTN/UNOS Executive Committee executed this policy change on October 23, 2009, after reviewing the DTAC s public comment proposal to move to retrospective donor testing for a two year period and the responses from committees, regions and the general public. Available data suggest the very low prevalence of HTLV-1 in the donor population (approximately 0.03%), considerable discard of organs due to false positive results using screening tests, and favorable shortterm follow-up of recipients of HTLV-1/2 screen positive organs in the U.S. Until programming related to this change is complete, OPOs must still enter positive, negative or not done in the donor screening results field in order to generate a match run for organ placement. Transplant centers should be prepared to discuss HTLV as part of their standard pre-transplant informed consent process. In addition, centers should consider notifying candidates regarding the elimination of this screening requirement, as candidates have previously had the option to automatically opt out of offers for HTLV-1/2 positive organs. You may review the following article to learn more about HTLV: Kaul DR, Taranto SE, et al. Donor Screening for Human T-cell Lymphotropic Virus 1/2: Changing Paradigms for Changing Test Capacity. AJT. 2009; 9:epub ahead of print. PMID: REPORTS OF POTENTIAL TB TRANSMISSIONS ON THE RISE Over the past several years, there have been a number of transmissions of donor-derived Mycobacterium tuberculosis that have been reported to and investigated by DTAC. Since 2006, there have been 20 TB reports with 3 recipients with confirmed transmission and 2 TB-associated deaths resulting from these transmissions. A recent publication in the MMWR ( highlights one such transmission with an associated death. These cases allow us to identify potential challenges that contribute to a donor-derived tuberculosis transmission. First, there are no approved screening methods for detecting tuberculosis in donors. Disease can be transmitted if the donor had active infection, as was the case in many of the transmission events or in reactivation of latent infection in the transplanted organ. Cultures of lower airway material for tuberculosis are not routinely done during the procurement process and there is insufficient time to place and read a PPD. Interferon-gamma release assays and ELISPOT assays to screen for tuberculosis have not been studied in the donor population and could result in false positive results in the setting of brain death. Historical risk factors for latent and active TB, such as immigration from an endemic region, homelessness, alcoholism, and current or prior incarceration, are common among donors and non-specific. Further, there are significant challenges to identifying positive cultures obtained from a donor. Followup of outstanding culture, frequently collected well before the procurement process, have several challenges. Recognition that these samples have been collected may be incomplete in the data

3 collection process. Further, since Mycobacterium cultures are held for up to 8 weeks, the logistics of following-up on these results at the myriad of serviced hospitals may be technically challenging. There are also significant hurdles in the ability of the hospital, the hospital lab, and public health services to recognizing that a patient has become a donor, which can further hinder reporting. Lastly, recipients may have atypical presentations in the setting of donor-derived tuberculosis fever alone as well as sterile pyuria, for example, may contribute to a delay in diagnosis. Any time tuberculosis is suspected, it should be aggressively investigated and the potential donor origin should be considered. By doing so and rapidly communicating results among physicians, transplant centers, organ procurement organizations (OPOs), and public health authorities, the impact of the transmission could potentially be mitigated. OPOs and Transplant centers should review their process to be sure they have a plan in place to recognize and follow-up on outstanding Mycobacterial studies and to facilitate communications in the setting of a potential disease transmission. Michael Ison, MD DONOR DERIVED BACTERIAL TRANSMISSIONS AND THEIR CONSEQUENCES From January 2008 through August 2009, 198 case reports regarding potential donor derived transmission events were reviewed by the DTAC. Of these, 13 involved potential pyogenic bacteria. Six of these cases (2 Pseudomonas, 1 E coli, 1 Serratia, 1 VRE, and 1 Veilonella) had documented transmission from donor to recipient, with severe consequences in the majority of the recipients, including graft loss and recipient death. One additional donor was found to have bacteremia and preservation fluid cultures were positive; all recipients received appropriate antimicrobial coverage and no recipient infection or graft loss occurred. There were several common features shared by several of these cases. In several cases, the donors had sustained substantial abdominal trauma with both documented and potential gross contamination of the donor organs. Prophylactic antimicrobial therapy was not necessarily sufficient to cover the potential pathogens, especially when the risk of antibiotic resistance was underestimated. Graft loss and death were frequently related to anastomotic disruption. Although donors with both known and post donation identification of bacterial infections have been used successfully in the past, these cases highlight some critical features that should be considered in order to improve outcomes. In some cases there was a delay in communication between transplant centers and OPOs. Not all culture results were handled in a uniform manner and the lines of communication were not clear. Based on this, we recommend the following: Organs that may have been contaminated with bacteria due to the nature of the donor injury or findings at the time of donor procurement may harbor significant risk and may be used with caution. Every attempt should be made to fully disclose known donor bacterial infections prior to donation and recipients should receive antibiotic prophylaxis that specifically addresses the known microbiology. Results of cultures obtained at the time of donation should be promptly disclosed to the transplant centers as soon as they become available. Every center should develop a clear line of communication with the OPO so that it is always clear who will be responsible for receiving these results and communicating them to the medical team responsible for the recipient s care. All potential bacterial transmission should be promptly communicated to the OPTN. Emily Blumberg, MD

4 DONOR RCC AND ORGAN TRANSPLANTATION Organ transplants in which there is potential transmission of donor-associated tumors have been routinely reported to the DTAC. Committee members review the circumstances of the case, offer advice when appropriate, and assemble the information to discern trends and report back to the transplant community. In this manner we hope that the risk of tumor transmission will be minimized and the number of life-saving organs maximized. One pattern of clinical practice that has emerged relates to transplantation in the setting of solitary small renal cell carcinomas (RCC) in donor kidneys. Two potentially avoidable circumstances commonly led to delay in diagnosis of donor RCC. These included failure to adequately examine the kidney at the time of procurement, and delay in pathologic diagnosis of RCC. Such events were associated with transplant of other organs, or of the kidney itself, prior to knowledge of the presence of donor malignancy. Thorough examination of the donor kidney at time of recovery with sampling of any suspicious areas for frozen section analysis, and review by a qualified pathologist cognizant of the time constraints associated with transplant surgery, would reduce the frequency of such events. In other cases the diagnosis was made in a timely fashion and the kidney (and sometimes its contralateral mate) was discarded. Literature review supports the position that a kidney with solitary small well-differentiated RCC may be used for transplant at the discretion of the transplant center in clinically appropriate cases if the tumor is resected with clean surgical margins prior to implantation. In such instances, the patient should be fully informed and the appropriate consent obtained before the transplant is performed. If either the transplant surgeon or the patient does not wish to proceed under these circumstances, the OPO should be informed so that the organ can be offered to other centers for consideration in accordance with OPTN Policy Decisions regarding use of organs from donors with known or suspected malignancy are difficult and typically occur under stressful conditions with few guidelines. The Malignancy Subcommittee of DTAC is preparing a guidance document to aid such decision making, which remains the responsibility of the transplant surgeon and requires the informed consent of the potential transplant recipient. Michael Nalesnik, MD HOW YOU CAN REPORT A POTENTIAL DISEASE TRANSMISSION Does your OPO or transplant center know when and how to report a potential disease transmission event? OPTN Policy 4.7 (Post-Transplant Reporting of Potential Transmission of Disease or Medical Conditions, Including Malignancy) outlines reporting requirements for members. The overall intent is to communicate information/concern as quickly as possible to all transplant centers programs that have accepted organs from a donor so that centers may use their medical judgment as to which, if any, investigations or actions need to be performed for their recipients. Transplant programs must notify the host OPO by phone as soon as possible, and not to exceed one complete working day, when a recipient is confirmed positive or has died from a transmissible disease or medical condition for which there is substantial concern of donorderived transmission. Centers should not wait for all medical documentation that will be available, but rather transfer information related to the potential transmission as soon as possible. Centers may choose to report directly to the Patient Safety System, but are required to notify the Host OPO per policy. OPOs are considered the communication hub for reported events. OPOs may report an event after transplant center notification or report post-transplant donor findings or other information not available to transplant centers prior to recovery that may lead to potential disease transmission (i.e. final cultures, autopsy results, etc.). They are responsible for: (1) sharing any test results and diagnosis as soon as possible to all transplant centers and tissue banks

5 involved with the donor who is the subject of the reported event and ongoing communication to determine whether the organ donor was diagnosed with a potentially transmissible disease or condition, (2) notifying the OPTN through the Patient Safety System SM as soon as possible, and (4) submission of Initial and 45 Day Report Forms to the OPTN. The documents are used to record which organizations and individuals were notified and when this notification occurred as well as follow up on all organ recipients that are subjects of the investigation. Early communication is key to the potential disease transmission reporting process! For more information or questions on how or when to report potential disease transmission events to the OPTN, please call and ask for a Patient Safety staff member: Kimberly Parker, Patient Safety Coordinator Kimberly Taylor, RN, Senior Patient Safety Specialist Shandie Covington, Staff Liaison to the DTAC ADDITIONAL INFORMATION For more information about the DTAC s review of potential donor-derived disease transmission events reported to the OPTN, you may wish to review the following article: Ison MG, Hager J, et al. Donor-Derived Disease Transmission Events in the United States: Data Reviewed by the OPTN/UNOS Disease Transmission Advisory Committee. AJT. 2009; 9; If you have questions related to this newsletter, the DTAC, or you are interested in becoming a member of this committee, please contact Shandie Covington at shandie.covington@unos.org.