Final Revision Process for the PHS Guideline for Reducing HIV, HBV and HCV Transmission through Organ Transplantation Matthew J. Kuehnert, M.D. Office of Blood, Organ and other Tissue Safety Advisory Committee on Organ Transplantation August 28. 2012 National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion
Final Revision Process for the PHS Guideline for Reducing HIV, HBV and HCV Transmission through Organ Transplantation . Matthew J. Kuehnert, M.D. Office of Blood, Organ and other Tissue Safety Advisory Committee on Organ Transplantation August 28. 2012. - PowerPoint PPT Presentation
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Final Revision Process for thePHS Guideline for Reducing HIV, HBV and HCV Transmission through Organ
Transplantation Matthew J. Kuehnert, M.D.
Office of Blood, Organ and other Tissue Safety
Advisory Committee on Organ TransplantationAugust 28. 2012
National Center for Emerging and Zoonotic Infectious DiseasesDivision of Healthcare Quality Promotion
PHS Guideline Development
“Guidelines for Preventing Transmission of Human Immunodeficiency Virus Through Transplantation of Human Tissue and Organs” published in 1994 by the Public Health Service (PHS)
Agreement that PHS guidelines need revision
Association for Organ Procurement Organizations (AOPO), followed by other transplant organizations, sent letters to CDC suggesting guideline revision in
2008Objective process developed for PHS guideline revision and update
Important Differences in Focus –1994 versus Revised Draft Guideline1994: PHS Guideline for Preventing
Transmission of Human Immunodeficiency Virus through Transplantation of Human Tissue and Organs
– Organs and tissues; banked breast milk and semen
– Transmission of HIV only
Revised Draft: PHS Guideline for Reducing HIV, HBV and HCV Transmission through Organ Transplantation
– Organs only– Transmission of HIV, hepatitis B virus
(HBV), and hepatitis C virus (HCV)– Evidence-based process
Evidence-based Process for Revision
HHS agencies and external experts from transplant community provided inputCDC lead for PHS agencies in developing a draftRecommendations based on systematic review of the best available evidence Evidence review conducted by:
– Center for Evidence-based Practice (CEP) at University of Pennsylvania
– ECRI Institute/Evidence-based Practice Center (EPC)
National Center for Emerging and Zoonotic Infectious DiseasesDivision of Healthcare Quality Promotion
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Expert Panel (EP)Experts in Consent Issues, Hepatitis and HIV Content, and Laboratory Medicine;
OPO Representative; Physicians in Transplant, Transplant ID, and Transplant
Surgery
Review Committee (RC)Representatives from AOPO, AST, ASTS,
CSTE, NATCO, UNOS, Industry; and Ad Hoc Members
PHS representatives from CMS, FDA, HHS/OPHS, HRSA, and NIH
Advisors for Guideline Development
National Center for Emerging and Zoonotic Infectious DiseasesDivision of Healthcare Quality Promotion
Phase 1: Organize Advisors for Guideline Development
Phase 2: Preliminary Literature Search in Support of Questions for Systematic Review
Phase 3: Development of Questions for Systematic Review and Analytic Framework
Phase 4: Production of Evidence Report
Phase 5: Guideline Development
PHS Guideline Development Methodology Five Phases
2008
2012
Categories of PHS Guideline Recommendations
Donor Risk Assessment Donor Screening
Includes Table of risk factors for recent infection of HIV, HBV, HCV
HBV-Infected Donors and Transplantation HCV-Infected Donors and Transplantation Recipient Informed Consent Recipient Testing Donor and Recipient Specimen Collection
and Storage Tracking and Reporting of HIV, HBV and HCV
Process for Revision of PHS Guideline
HHS offices and agencies, including CDC, HRSA, FDA, and CMS, reviewed and approved the draft Guideline
Federal Register Notice Draft guideline accessed at www.regulations.gov 90-day public comment period - ended 12/23/11
Approximately 100 comments were received All comments were reviewed PHS Guideline Revision Work Group convened
to review and discuss changes to recommendations Agreed on changes to the guideline
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
National Center for Emerging and Zoonotic Infectious DiseasesDivision of Healthcare Quality Promotion
Major Changes to PHS Guideline In Response to Public Comment and
External Input
Number of recommendations decreased from 54 to 32
Sections on HBV- and HCV-infected Donors and Transplantation were deleted
Donor testing for HIV changed from NAT for all donors to NAT or Ag/Ab for increased risk donors
Donor testing for HBV changed from NAT for increased risk donors to no recommendation
Living Donor testing changed from within 7 to within 28 days of organ recovery
Recipient testing (based on increased donor risk) reduced and changed to broader timeframes after transplant
Major Changes to PHS Guideline In Response to Public Comment and
External Input
Regarding storing blood specimens for future testing (for the possibility of donor-derived disease transmission investigation) Recommendations changed to limit to storing specimens
from deceased donors only (no recommendations for living donors or recipients)
Recommendations on division of donor specimens into multiple aliquots for storing was deleted