Download ACOT_Feb2012_final_for committee_Matthew Kuehnert(Feb

Revision Process for the
PHS Guideline for Reducing HIV, HBV and HCV
Transmission through Solid Organ Transplantation
Matthew J. Kuehnert, M.D.
Office of Blood, Organ and other Tissue Safety
Advisory Committee on Organ Transplantation
February 28. 2012
National Center for Emerging and Zoonotic Infectious Diseases
Division 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 2008

Objective process developed for PHS guideline
revision and update
Important Differences in Focus –
1994 versus Revised Draft Guideline
• 1994: 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
Solid 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 input
• CDC lead for PHS agencies in developing a
draft
• Recommendations 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)
Advisors for Guideline Development
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
National Center for Emerging and Zoonotic Infectious Diseases
Division of Healthcare Quality Promotion
5
5
PHS Guideline Development Methodology
Five Phases
Phase 1: Organize Advisors for Guideline
Development
2008
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
National Center for Emerging and Zoonotic Infectious Diseases
Division of Healthcare Quality Promotion
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 are being reviewed
Next Steps For Finalizing the PHS Guideline


Comments mapped to recommendations
Convene PHS Revision Task Group
 Review comments and change options
 Agree on changes to the guideline

Reconvene Expert Panel and Review Committee
 Review guideline and provide input
 HHS agencies consider any suggested changes


Submit guideline for HHS clearance
Publication as final Guideline*
*Recommendations will not be regulation or policy
Questions or Comments?
For more information please contact Centers for Disease Control and Prevention
1600 Clifton Road NE, Atlanta, GA 30333
Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348
E-mail: [email protected] Web: http://www.cdc.gov
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 Diseases
Division of Healthcare Quality Promotion