Policy: Kidney/Pancreas Pre-Transplant: Evaluation Recipient Hepatitis C Testing/Evaluation Protocol
Statement: 1. Activation date: 10/01/2009
2. Affected Department: Kidney/Pancreas and Liver Transplant Program and The Departments of Radiology, Lab
Services and Pathology of Emory Healthcare
3. Vision Strategy: Patient Care
4. Policy Statement: The Emory Transplant Center will comply with all applicable federal, state and local laws,
regulations and policies regarding patient
care.
5. Basis: This policy is necessary for the protection of patients, physicians and staff
6. Administrative Responsibility: Section heads, physicians, practitioners, and staff are responsible for compliance
with this policy.
Scope/Procedure:
Protocol Scope:
The Emory University Transplant Center will provide Hepatitis C antibody with confirmatory RIBA testing to all
renal/pancreas transplant evaluation candidates. Those candidates with positive Hepatitis C antibody / positive
confirmatory RIBA testing for Hepatitis C (HCV) will be receive HCV PCR (RNA) testing and Genotype
determination. Candidates who are HCV PCR positive will undergo Hepatology Consult and Liver Biopsy to
determine status. Candidates may be required to undergo HCV Anti-viral therapy to qualify for renal transplant.
Candidates for kidney transplant who are determined to be HCV PCR positive, Genotype 1, and receive clearance
from Hepatology will be considered for participation in the Hepatitis C Antibody Positive Donor Program.
Procedure:
1- TESTING
A. All patients who are evaluated for a kidney and/or pancreas transplant
will have the following basic testing as a part of their transplant
evaluation:
1) Hepatitis C Antibody Testing with confirmatory RIBA if Hepatitis C
Antibody is Positive
2) Hepatitis C PCR (RNA) if #1 is indeterminate or positive
Note: Viral Load will be determined with Hepatitis C PCR
B. Patients who test Hepatitis C PCR positive will have the following advanced
testing as part of their transplant evaluation:
1) MRI of Abdomen
2) Genotype Testing
3) Emory Transplant Hepatology Consult with review of Liver Biopsy results
4) May or may not need/elect anti-viral therapy prior to transplant.
a) Therapy will be determined by Hepatologist
b) Repeat PCR assessment as determined by Hepatology
c) If the patient elects anti-viral therapy and is successfully treated
resulting in a repeat Negative Hep C PCR, he/she will not be eligible
for participation in our Program to Receive a Kidney from a donor
with Antibodies to Hepatitis C
2- Informed Consent for Participation in Program to Receive a Kidney from a
Donor with Antibodies to Hepatitis C.
A. Potential Candidates Must:
1) Be Hepatitis C PCR (RNA) positive
2) Be Genotype 1
3) Cleared by Emory Hepatology for Kidney Transplant
4) Have acceptable Liver Biopsy
5) Have Renal Transplant Reviewing Surgeon’s notation in OTTR record
confirming patient is candidate for HCV Donor Program
6) Receive Hepatitis C education and consent letter along with consent for
program. Hep C Consent Letter and Informed Consent for Hep C.
a) Documents will be sent to patient with listing agreement by Call Center
coordinator staff. Action is created in OTTR: Hep C Consent
7) Patient will: Initial, sign and return Informed Consent for Participation in
the Program to Receive a Kidney from a Donor with Antibodies to
Hepatitis C
B. Once Consent has been returned to program:
1) Medical Secretary will log consent indication into action in OTTR
patient record Action : Hep C Consent and mark done.
2) Listing Coordinator will enter consent indication in UNOS listing
on line document
3) Medical Secretary will code and send consent document to scanner to be
entered under listing documents in on line medical record.
Approved by: Renal Transplant Leadership Group
_____________________________________
Thomas C. Pearson, M.D., DPhil
Chair, Renal Transplant Leadership Group
Director, Renal Transplant Program
Approval Dates: 10/01/2009