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Fiftieth ACBTSA Meeting

April 15, 2019 - April 16, 2019

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. 

Meeting Summary - April 15

Meeting Summary - April 16

Slide Presentation - April 15 (Content is undergoing 508 review and will be updated pending remediation. For assistance, please contact tickbornedisease@hhs.gov)

Slide Presentation - April 16 (Content is undergoing 508 review and will be updated pending remediation. For assistance, please contact tickbornedisease@hhs.gov)

Archived Webcast

Federal Register Meeting Notice

Federal Register Notice, Amendment

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
Robert R. Redfield, 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