April 15, 2019 - April 16, 2019
Meeting Materials
The 50th meeting of the ACBTSA was held on April 15 from 8:30 AM to 5:00 PM EDT and April 16 from 8:30 AM to 4:00 PM at the U.S. Department of Health and Human Services, Hubert H. Humphrey Building. For this meeting, public- and private-sector stakeholders in organ transplantation were seeking to explore potential important updates to the 2013 PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Transmission Through Organ Transplantation in order to maintain accordance with current health sector circumstances.
Slide Presentation - April 15 (Content is undergoing 508 review and will be updated pending remediation. For assistance, please contact [email protected])
Slide Presentation - April 16 (Content is undergoing 508 review and will be updated pending remediation. For assistance, please contact [email protected])
Agenda
April 15, 2019
| TIME | AGENDA ITEM | SPEAKER |
|---|---|---|
|
Committee Business |
||
| 8:00 a.m. | Doors Open April 15th 2019 | |
| 8:30 a.m. | Call to Order | Jackie Fredrick, MT(ASCP)SBB, MBA, Hon DB/DPH |
| 8:35 a.m. | Roll Call | James Berger, MS, MT(ASCP)SBB |
| 8:40 a.m. | FDA/BPAC Update | Carlos Villa, MD |
| 8:50 a.m. | Purpose of the Meeting | Emily Blumberg, MD |
|
Landscape of Theme |
||
| 9:00 a.m. | Overview of Federal Agency Roles and Responsibilities Regarding Transplant Safety | Marilyn Levi, MD |
| 9:30 a.m. | The Assistant Secretary for Health and the CDC Director - Committee Address |
Admiral Brett Giroir, MD |
| 10:15a.m. | Overview of the OPTN - Roles and Responsibilities | David Klassen, MD |
| 10:30 a.m. | Morning Break | |
| 10:45 a.m. | Historical Background of PHS Role in Prevention of HIV, HBV, HCV Transmission through Organ Transplantation: Focus on 1994 to 2013 | Matthew Kuehnert, MD |
| 11:25 a.m. | Historical Perspective on the Establishment of DTAC | Mike Ison, MD |
| 11:45 a.m. | Feedback from the Transplant Community: Need for Guideline Recommendation Revision; Data Gathering and Analyses to Inform Current Revision Efforts; Aspects of Recommendations Amenable to Revision | Sridhar Basavaraju, MD |
| 12:30 p.m. | Lunch | |
|
Stakeholders |
||
| 1:30 p.m. | DTAC Experience in Disease Transmission and Outcomes | Cameron Wolfe, MBBS |
| 1:45 p.m. | DTAC Perspective and Opinions on Necessary Changes to the PHS Guideline Recommendations | Marian Michaels, MD, MPH |
| 2:00 p.m. | HIV/HCV in Organ Transplantation: Clinical Trials and Outcomes | Christine Durand, MD |
| 2:45 p.m. | Afternoon Break | |
| 3:00 p.m. | Ethics of Informed Consent of Recipients of Increased Risk Donor Organs | Peter Reese, MD |
| 3:30 p.m. | OPO Experience: How are Increased Risk Donors Identified; Limitations of Next-of-Kin Interview; Transmission of Information to Recipient Centers | Charlie Alexander, MSN, MBA |
| 3:45 p.m. | OPO Experience: How are Increased Risk Donors Identified; Limitations of Next-of-Kin Interview; Transmission of Information to Recipient Centers | Richard Hasz, MFS |
| 4:00 p.m. | ASTS Perspective on Proposed Revision to Guideline Recommendations | Dixon Kaufman, MD |
| 4:15 p.m. | AST Comment on Proposed Revision to Guideline Recommendations | Nicole Turgeon, MD |
| 4:30 p.m. | AOPO Comment on Proposed Revision to Guideline Recommendations | Diane Brockmeier, BSN, MA |
| 4:45 p.m. | First Day Wrap-up and Adjournment @ 5:00 p.m. | |
April 16, 2019
| TIME | AGENDA ITEM | SPEAKER |
|---|---|---|
|
Committee Business |
||
| 8:00 a.m. | Doors Open April 16th 2019 | |
| 8:30 a.m. | Call to Order | Jackie Fredrick, MT(ASCP)SBB, MBA, Hon DB/DPH |
| 8:40 a.m. | Roll Call | James Berger, MS, MT(ASCP)SBB |
| 8:50 a.m. | First Day Recap of the Meeting | Emily Blumberg, MD |
|
Committee Discussion |
||
| 9:00 a.m. | Committee Address | HHS Secretary Alex M. Azar II |
| 9:20 a.m. | PHS Guideline Discussion | Emily Blumberg, MD |
|
PHS Guideline for Reducing HIV, HCV, and HBV Through Organ Transplantation - Does the available information support a reduction of the current 12-month risk behaviors time frame for determining increased risk donor designation? - Is there a more appropriate term than “increased risk donor” to designate donors with risk factors for undetected HIV, HBV, or HCV infection? - Should some criteria for increased risk donors be modified (e.g., hemodilution of specimen used for HIV, HBV, or HCV testing, history of STD, or outpatient hemodialysis)? |
||
| 10:30 a.m. | Morning Break | |
| 10:50 a.m. | Continued Discussion on Questions for the Committee | |
| 12:00 p.m. | Lunch | |
|
Committee Recommendations |
||
| Public Comments | ||
| 1:00 p.m. | Formulation of Committee Findings and Recommendations | Emily Blumberg, MD |
| 3:45 p.m. | New Business and Next Steps | Jackie Fredrick, MT(ASCP)SBB, MBA, Hon DB/DPH |
| 4:00 p.m. | Adjournment | James Berger, MS, MT(ASCP)SBB |
