Organ Transplantation Program Update March 7, 2013 Christopher J. McLaughlin Chief, Organ Transplantation Branch Division of Transplantation Department of Health and Human Services Health Resources and Services Administration Healthcare Systems Bureau
OPTN Policy Updates Kidney Allocation Policy OPTN Kidney Committee released proposal for public comment Fall 2012 Proposal intended to enhance post-transplant survival benefit, increase utilization of donated kidneys and increase transplant access for biologically disadvantaged candidates. Proposal included several features: expanded definition of waiting time based in part on the date of initiation of renal dialysis, a sliding scale for assigning points to sensitized patients, expanded access for blood type B candidates who can accept kidneys from subtypes of blood type A donors, broader sharing for extremely highly sensitized candidates, longevity matching of some kidneys, and regional sharing for kidneys with the highest risk of discard.
OPTN Policy Updates SRTR Liver Region Redesign Project HRSA provided additional funding to SRTR to develop an evidencebased approach to optimize geographic distribution of livers. Approach is to design allocation policies using a principles-based framework and mathematical optimization. OPTN Liver Committee will need to identify consensus on a principle to optimize in regional allocation a primary metric for evaluating any proposed allocation system Mathematical optimization identify aggregate geographic areas that maximize/equalize the principle across areas Much of the modeling complete OPTN Board has charged the Liver Committee to identify by June 2013 a principle to guide the optimization process.
OPTN Policy Updates Living Kidney Donation OPTN approved three Living Kidney Donor policies last Fall Medical and Psychosocial Evaluation Informed Consent Follow-up Living Donor Committee has developed checklists to assist programs in meeting the policies and these have been placed on the OPTN website. Living Liver Donor policies are in development Policy proposal outlining Independent Living Donor Advocate requirements ready for public comment
Policy Updates Status of VCA Addition to OPTN Final Rule Vascularized Composite Allografts (VCA) NPRM Published December 17, 2011 Closed February 14, 2012 28 comments received favorable Final Rule revision undergoing review
OPTN Contract Extension/Recompetition OPTN contract in place since 2005 has been extended through June 30, 2013 HRSA published RFI last year seeking input on: Use of subcontracting OPTN National KPD program Enhanced public participation Enhanced OPTN education efforts Modifying OPTN research capacity Improving IT capacity and responsiveness Request for Proposals posted February 22 Proposals due April 5
OPTN Deceased Donor Potential Study HRSA provided $1.6 million direct funding to UNOS (Center for Transplant System Excellence) to conduct a study evaluating donor potential in the U.S. Findings expected to serve as basis for evidence-based goal setting Demographic and epidemiological approaches Systems dynamics modeling Measure variables affecting donor potential Address full range of donor potential Findings to be completed by end of current OPTN contract
OPTN/SRTR PSR Conference Follow-up Consensus conference on Transplant Program Quality and Surveillance took place last year. Short- and Long-Term Action Items listed and updated on the SRTR web site Key follow-up PSR Manual of Operations developed detailing the SRTR process for risk model development and oversight. 3-year cycle of model development with formal input and involvement from the OPTN committees kidney model first to be rebuilt OPTN input sought on variables STAC recommendation to revise PSRs using Bayesian methodology SRTR working with OPTN MPSC to develop new flagging criteria
SRTR PSR and OPO Report Improvements New format for transplant program PSRs using color and enhanced visual display to depict the same content in the traditional program-specific report. OPO-specific reports now contain measures of expected donor yield using the models approved by the OPTN/UNOS Board in 2011. The SRTR released a Donor Yield Calculator tool available for download on the secure websites that OPOs can use to track observed and expected donor yield using the new models. New OPO report format being reviewed.
HRSA/CMS Alignment Activities Consistent with ACOT recommendation 55, HRSA, CMS, and the OPTN contractor have continued to work to identify areas to harmonize oversight and regulation of transplant centers and OPOs. First effort was a crosswalk of transplant center requirements from the CMS transplant center Conditions of Participation and the OPTN Bylaws and Policies. Crosswalk will enhance efforts underway to modify OPTN and CMS requirements and survey processes to address areas that are similar but not identical. Findings may lead to modifications in OPTN and CMS oversight activities
Community of Practice Organ Donation and Transplantation Community of Practice
Public & Professional Education Projects to Increase Donation 50+ Campaign Workplace Hospital Campaign Promotional Materials (English/Spanish) PSAs appearing in major National magazines Electronic: Radio, TV, organdonor.gov, Facebook
Public & Professional Education 50+ Campaign Goal is to increase registry enrollment among people ages 50+ Partnership with National Institute on Aging and Administration on Aging Messaging Any age is the right age to sign up to be an organ, eye, and tissue donor. Don t rule yourself out age and medical condition don t automatically disqualify you. Launched by HHS Assistant Secretary for Health, Dr. Howard Koh with a Radio Media Tour (RMT) aired on 2,736 stations reaching 18 million listeners
Public & Professional Education 50+ Campaign Why Focus on Older People? In 2011, people +50 were: 64% of waiting list 60% of recipients 32% of donors 21 million 50+ believe that they are too old to donate More than 99 million in the US are 50+
Public & Professional Education Hospital Campaign Goal is to involve hospitals and state hospital associations in organ registry enrollment Partners: 700 hospitals 88% of OPOs 48% of state hospital associations
Public & Professional Education Social Media Launched Organdonor.gov on Facebook Posts three times per week organ, eye, and tissue recipients Organdonor.gov content and questions Current events, news, stories, shareable graphics
Public & Professional Education Print Materials PSAs Better Homes and Gardens Ebony Forbes Mental Floss (2 issues) Newsweek (7 issues) Donation Process Video (in development) Goal is to demystify donation and transplantation process
HHS Innovation Entrepreneurs Program DoT chosen to participate in an HHS program designed to increase innovative thinking and problem solving in the Department. External Entrepreneur/Fellow has join us for one year to help us work with the OPTN to identify a possible new system for electronic identification and tracking of organs. OPTN Ad hoc committee guiding efforts to develop application to generate electronic organ labels and scanning capability to track organs from procurement to transplantation
Questions?
Contact Information Chris McLaughlin Chief, Organ Transplantation Branch Division of Transplantation 301-443-0036 cmclaughlin@hrsa.gov