Ad Hoc Disease Transmission Advisory Committee:

A Report to the OPTN/UNOS Board

Emily A. Blumberg, MD, ChairMichael D. Green, MD, MPH, Vice Chair

Shandie Covington, Staff Liaison

June 25-26, 2012Richmond, Virginia

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

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

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

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

Potential Donor Derived Transmission Events

7

Potential Donor Derived Transmission Events 2011

*all unlikely or excluded

InfectionsOrganism # Donors # Recipients

(proven/probable)# Related Deaths

Bacteria (excl TB) 36 136 (3) 0

TB 14 42 (1) 1

HBV 13 35 (4) 0

HCV 11 34 (4) 0

Resp Virus (Influenza) 3 (2) 12 (0) 0

Cryptococcus 10 27 (1) 0

Histoplasmosis 5 19 (1) 0

Candida 4 10 (0) 0

Aspergillus 2 8 (2) 0

Strongyloides/T cruzi 4 11 (4) 0

Other 24 92(12*) 5**

Total 126 426(31) 6

* Scopulariopsis, LCMV, WNV, HHV8, CMV, Toxoplasmosis; ** Scopulariopsis,WNV, LCMV

Malignancies

Malignancy # Donors # Recipients (proven/probable)

# Related Deaths

Renal 21 47 (2) 0

Adenocarcinoma 4 8 (1) 1

Lung/Pleural 4 17 (3) 3

Leukemia/Lymphoma 3 3 (1) 0

Liver 4 58(2) 0

Melanoma 2 6 (3) 2

Other 13 40 (4*) 1

Total 49 111 (16) 7

* Includes paraganglioma, choriocarcinoma, and urothelial cell carcinoma

What Has DTAC Learned?2006 2007 2008 2009 2010 2011 TOTAL

Total # of PDDTE reported

60 97 102 152 157 181 749

Total # and % classified as proven or probable*

13(22%)

4(4%)

16(16%)

33(22%)

30(19%)

31(17%)

12717% of all reported

PDDTE… but <1% of all

donors

Total # of Donors**

14,751 14,400 14,208 14,632 14,506 14,144 86,641

Total # of Deceased Donors**

8,019 8,085 7,990 8,022 7,943 8,127 48,186

* Subject to change after extended follow-up**Cases reported include some donors recovered in previous years.

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

Thank you!Dr. Michael Green Shandie CovingtonChildren’s Hospital of UNOSPittsburgh of UPMC Sr. Patient Safety SpecialistIncoming Chair LiaisonMichael.Green@chp.edu shandie.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?

***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.