1. Ad Hoc Disease Transmission Advisory Committee: A Report to the OPTN/UNOS Board Emily A. Blumberg, MD, Chair Michael D. Green, MD, MPH, Vice Chair Shandie Covington, Staff Liaison June 25-26, 2012 Richmond, Virginia

2.  DTAC News e-newsletter  Ongoing as needed to share information  Guidance for considering donor with meningoencephalitis of unknown etiology  Reviewed at this meeting  Proposed Minimum Screening Requirements for Living Donors  Feedback to Living Donor Committee on this proposal during development BOD Approved Committee Projects

3.  Improvements to disease reporting page on Improving Patient Safety portal  Business Requirements being finalized, then to Exec Committee for placement into programming queue  Follow-up survey of all OPOs regarding donor screening practices  Remains on hold pending release of finalized US PHS Guidelines, as this is expected to change OPO screening practices to some degree Ongoing BOD Approved Committee Projects

4.  CDC reviewed all responses received from Fall 2011 public comment period.  Overview of modifications to the Guidelines shared publically at the American Transplant Congress talk on June 5  Call with the Expert Review Panel held on June 11 to review revised recommendations.  Feedback from call submitted no later than June 15. US PHS Guidelines Update

5.  Multi-organizational stakeholder group worked on this effort.  DTAC provided feedback early on and had an unofficial representative on working group  2 forms planned- adult and <12 y/o.  Peds (<12 y/o) form still being finalized  Final adult document out and in beta testing phase now.  far more generally worded than AOPO format of medical-social history Universal Donor Health Questionnaire

6. Potential Donor Derived Transmission Events 7

7. Potential Donor Derived Transmission Events 2011 181 PDDTE Infections 126 Proven/ Probable 20 Possible 10 IWDT 29 Unlikely/ Excluded 67 Other 4* Malignancies 51 Proven/ Probable 11 Possible 7 IWDT 4 Unlikely/ Excluded 29 *all unlikely or excluded

8. Infections Organism# Donors# Recipients (proven/probable) # Related Deaths Bacteria (excl TB)36136 (3)0 TB1442 (1)1 HBV1335 (4)0 HCV1134 (4)0 Resp Virus (Influenza)3 (2)12 (0)0 Cryptococcus1027 (1)0 Histoplasmosis519 (1)0 Candida410 (0)0 Aspergillus28 (2)0 Strongyloides/T cruzi411 (4)0 Other2492(12*)5** Total126426(31)6 * Scopulariopsis, LCMV, WNV, HHV8, CMV, Toxoplasmosis; ** Scopulariopsis,WNV, LCMV

9. Malignancies Malignancy# Donors# Recipients (proven/probable) # Related Deaths Renal2147 (2)0 Adenocarcinoma48 (1)1 Lung/Pleural417 (3)3 Leukemia/Lymphoma33 (1)0 Liver458(2)0 Melanoma26 (3)2 Other1340 (4*)1 Total49111 (16)7 * Includes paraganglioma, choriocarcinoma, and urothelial cell carcinoma

10. What Has DTAC Learned? 200620072008200920102011TOTAL Total # of PDDTE reported 6097102152157181749 Total # and % classified as proven or probable* 13 (22%) 4 (4%) 16 (16%) 33 (22%) 30 (19%) 31 (17%) 127 17% of all reported PDDTE… but <1% of all donors Total # of Donors** 14,75114,40014,20814,63214,50614,14486,641 Total # of Deceased Donors** 8,0198,0857,9908,0227,9438,12748,186 * Subject to change after extended follow-up **Cases reported include some donors recovered in previous years.

11. Dr. Emily Blumberg (Chair, TID) Dr. Mike Green (Vice Chair, Peds TID) Ms. Carrie Comellas (TX Coord)Dr. Ed Dominguez (TID) Dr. Afshin Ehsan(Thoracic Surgeon)Barry Friedman (TX Admin) Dr. Tom Gross (Peds Hem/Onc) Dr. Dan Kaul (TID) Dr. Shimon Kusne (TID)Dr. Marshall Lyon (TID) Dr. Rachel Miller (TID)Ms. Samantha Mitchell (OPO) Dr. Michael Nalesnik (Pathology)Dr. Volker Nickeleit (Pathology) Dr. Martha Pavlakis (Nephrology)Dr. Tim Pruett (Abd TX Surgeon) Dr. Phillip Ruiz (Pathology)Dr. Michael Souter(OPO Med Dir) Dr. Betsy Tuttle-Newhall (Abd Surgeon)Ms. Linda Weiss (OPO Lab Dir) Dr. Russ Wiesner (Hepatologist)Dr. Susan Hocevar (CDC) Dr. Jim Bowman (HRSA)Dr. Bernie Kozlovsky (HRSA) Ms. Raelene Skerda (HRSA) Dr. Karen Near (HRSA) DTAC 2011-2012

12. Thank you! Dr. Michael Green Shandie Covington Children’s Hospital of UNOS Pittsburgh of UPMC Sr. Patient Safety Specialist Incoming Chair Liaison Michael.Green@chp.eduMichael.Green@chp.edu shandie.covington@unos.orgshandie.covington@unos.org (412) 692-6111 (804) 782-4929 Special thanks to Sarah Taranto, Kimberly Taylor, Kimberly Parker, Cassandra Meekins as well as the entire Committee! Questions?

14. ***RESOLVED, that the OPTN request a meeting with the HHS to discuss the proposed U.S. Public Health Service Guidelines for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) through Solid Organ Transplantation before such guidance is approved, in order to discuss the potential impact on OPTN policies, in accordance with the Final Rule § 121.4 (2), which requires that OPTN policies be consistent with recommendations of the CDC, for the testing of organ donors and follow-up of transplant recipients to prevent the spread of infectious diseases.