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Table 1.  

Risk criteria No. of donors associated with donor-derived transmission events
HIV HBV HCV
No. of donors associated with transmission events
1
14
23
No. of donors with criteria resulting in IRD designation
Sex with a person known or suspected to have HIV, HBV, or HCV infection
0
0
2
Man who has had sex with another man
1
0
0
Woman who has had sex with a man who has had sex with another man
0
0
0
Sex in exchange for money or drugs
0
1
4
Sex with a person who had sex in exchange for money or drugs
0
4
2
Drug injection for nonmedical reasons
0
10
19
Sex with person who injected drugs for nonmedical reasons
0
5
4
Incarceration (confinement in jail, prison, or juvenile correction facility) for ≥72 consecutive hours
0
8
10
Newly diagnosed or treated syphilis, gonorrhea, chlamydia, or genital ulcers
0
1
0
Child (aged ≤18 months) born to a mother known to be infected with or at increased risk for HIV, HBV, or HCV infection
0
0
0
Child breastfed by a mother known to be infected with or at increased risk for HIV infection
0
0
0
Hemodialysis
0
0
0
Unknown medical or social history
0
1
2
Hemodiluted blood specimen used for donor HIV, HBV, or HCV testing 0 0 0

Table 1. Number of increased risk donors* and risk criteria associated with donor-derived human immunodeficiency virus, hepatitis B, and hepatitis C transmission events reported to the Organ Procurement and Transplantation Network Disease Transmission Advisory Committee — United States, 2008–2018

Source: Organ Procurement and Transplantation Network. Organ Procurement and Transplantation Network Disease Transmission Advisory Committee report database. Richmond, VA: US Department of Health and Human Services, Health Resources and Services, Organ Procurement and Transplantation Network; 2019. https://optn.transplant.hrsa.gov/members/committees/disease-transmission-advisory-committee.

Abbreviations: HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; IRD = increased risk donor.

* A total of 38 increased risk donors were identified. Each donor-derived transmission event was associated with a single virus only.

Increased risk donors could meet more than one risk criteria, and all criteria were included.

Box.  

  1. 1. Initial transplant candidate informed consent discussion and vaccination
  2. 2. Risk assessment of living and deceased donors
  3. 3. Living and deceased solid organ donor testing
  4. 4. Transplant candidate informed consent discussion, including donor risk factors
  5. 5. Recipient testing
  6. 6. Collection and storage of donor and recipient specimens
  7. 7. Tracking and reporting of donor-derived disease transmission events

BOX. Steps in the organ transplantation process related to the U.S. Public Health Service guideline recommendations for assessing solid organ donors and monitoring transplant recipients for human immunodeficiency virus, hepatitis B virus, and hepatitis C virus infection

Table 2.  

Recommendation category 2013 2020
Risk assessment of living and deceased donors
  • • OPOs should ascertain whether any of the following 14 risk criteria were present in potential organ donors.

  • • OPOs should ascertain whether any of the following 10 risk criteria were present in potential organ donors.

  • • Donors with any risk criteria should be designated as IRDs for an acute HIV, HBV, and HCV infection.

  • • Remove any specific label (e.g., “increased risk donor”) to describe donors with risk factors for acute HIV, HBV, and HCV infection.

  • • Risk criteria (during the 12 months before organ procurement):
    1. 1. Sex with a person known or suspected to have HIV, HBV, or HCV infection
    2. 2. Drug injection for nonmedical reasons
    3. 3. Man who has had sex with another man
    4. 4. Incarceration (confinement in jail, prison, or juvenile correction facility) for ≥72 consecutive hours
    5. 5. Sex in exchange for money or drugs
    6. 6. Sex with a person who injected drugs for nonmedical reasons
    7. 7. Sex with a person who had sex in exchange for money or drugs
    8. 8. Unknown medical or social history
    9. 9. Child aged ≤18 months born to a mother known to be infected with or at increased risk for HIV, HBV, or HCV infection
    10. 10. Child who has been breastfed by a mother who is known to be infected with or at increased risk for HIV infection
    11. 11. Woman who has had sex with a man who has had sex with another man
    12. 12. Newly diagnosed or treated syphilis, gonorrhea, chlamydia, or genital ulcers
    13. 13. Hemodialysis
    14. 14. Hemodilution of the blood sample used for infectious disease testing

  • • Risk criteria (during the 30 days before organ procurement):
    1. 1. Sex (i.e., any method of sexual contact, including vaginal, anal, and oral) with a person known or suspected to have HIV, HBV, or HCV infection
    2. 2. Man who has had sex with another man
    3. 3. Sex in exchange for money or drugs
    4. 4. Sex with a person who had sex in exchange for money or drugs
    5. 5. Drug injection for nonmedical reasons
    6. 6. Sex with a person who injected drugs for nonmedical reasons
    7. 7. Incarceration (confinement in jail, prison, or juvenile correction facility) for ≥72 consecutive hours
    8. 8. Child breastfed by a mother with HIV infection
    9. 9. Child born to a mother with HIV, HBV, or HCV infection
    10. 10. Unknown medical or social history

Living and deceased solid organ donor testing
  • • Test all potential organ donors (living and deceased)
    • ○ HIV: anti-HIV-1/2 or HIV Ag/Ab combination assay
    • ○ HBV: Anti HBc and HBsAg
    • ○ HCV: NAT and anti-HCV
    • ○ For IRD only, HIV NAT or HIV Ag/Ab combination

  • • Test all potential organ donors (living and deceased)
    • ○ HIV: NAT and anti-HIV
    • ○ HBV: NAT, anti-HBc, and HBsAg
    • ○ HCV: NAT and anti-HCV

  • • No time frame is specified for pretransplant deceased donor testing; however, results should be available at the time of transplant.

  • • For deceased potential donors, the donor specimen should be collected within 96 hours before organ procurement with results of these screening tests available at the time of organ procurement.

  • • Living donors should be tested within 28 days before transplantation.

  • • For living potential donors, testing should be performed as close as possible to the surgery but at least within the 28 days before organ procurement.

Transplant candidate informed consent
  • • Transplant center to obtain separate, specific informed consent from transplant candidates when donors are designated as IRDs

  • • When donors with one or more of the criteria as specified under Risk Assessment of Living and Deceased Donors are identified, OPOs should communicate this information to the appropriate transplant centers. Transplant centers should include this information in informed consent discussions with transplant candidates or their medical decision-makers. No separate, specific informed consent is recommended.

  • • Transplant centers should contextualize these discussions by including that risk for undetected HIV, HBV, and HCV infection is very low but not zero; should transmission occur effective therapies are available, and accepting organs from donors with risk factors might increase the chance for survival.

Recipient testing and vaccination
  • • Pretransplant testing of transplant candidates for HIV, HBV, and HCV infections is recommended when the donor (living or deceased) is designated as IRD or infected with HBV or HCV.
    • ○ Type of assay not specified
    • ○ Timing: during hospital admission for transplant but before transplant

  • • Pretransplant testing for HIV, HBV, and HCV infections should be conducted for all recipients, regardless of donor risk criteria.
    • ○ HIV: testing algorithm§
    • ○ HBV: anti-HBc, anti-HBs, and HBsAg
    • ○ HCV: NAT and anti-HCV
    • ○ Timing: During hospital admission for transplant but before transplant

  • • Regardless of 2013 guideline recommendations, Organ Procurement and Transplantation Network policy requires all transplant candidates to be tested for HIV, HBV, and HCV.

  • • Posttransplant testing of organ recipients for HIV, HBV, and HCV infections should be conducted when the donor (living or deceased) is designated as IRD or infected with HBV or HCV.
    • ○ Type of testing is not specified.
    • ○ Timing: testing should be performed at 1–3 months posttransplant for HIV, HBV, and HCV and again at 12 months for HBV.

  • • Posttransplant testing for HIV, HBV, and HCV infections should be conducted for all recipients, regardless of donor risk criteria.
    • ○ Type of testing: NAT for HIV, HBV, and HCV
    • ○ Timing: 4–6 weeks posttransplant
    • ○ Clinicians caring for liver recipients should maintain heightened awareness of the potential for delayed appearance of HBV infection and consider additional testing for HBV NAT at 1 year.
    • ○ Recipients who develop signs or symptoms of liver injury after transplantation should be retested for viral hepatitis.

  • • No previous PHS guideline recommendation exists for HBV vaccination of transplant candidates.

  • • All organ transplant candidates should be vaccinated against HBV infection.

Collection and storage of donor and recipient specimens
  • • OPOs should consider archiving a deceased donor blood sample for 10 years.

  • • OPOs and living donor recovery centers should archive donor blood specimens for at least 10 years. These specimens should be collected within 24 hours before organ procurement.

  • • No specific time frame is given for collection of archived samples relative to organ procurement.

Tracking and reporting of donor-derived disease transmission events    

Table 2. Comparison of 2013 and 2020 U.S. Public Health Service guideline recommendations* for solid organ donor assessment and transplant recipient monitoring for human immunodeficiency virus, hepatitis B virus, and hepatitis C virus infection

Abbreviations: anti-HBc = antibodies to hepatitis B virus core antigen; anti-HCV= antibodies to hepatitis C virus; anti-HIV-1/2 = antibodies to HIV-1/2; HbsAg = hepatitis B surface antigen; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; IRD = increased risk donor; OPO = organ procurement organization; NAT = nucleic acid testing.

* Only recommendations that were substantially modified from 2013 to 2020 are included. Recommendations that have minor wording changes or have been reorganized are not shown.

Sources: Bixler D, Annambholta P, Abara WE, et al. Hepatitis B and C virus infections transmitted through organ transplantation investigated by CDC, United States, 2014–2017. Am J Transplant 2019;19:2570–82; Jones JM, Gurbaxani BM, Asher A, et al. Quantifying the risk of undetected HIV, hepatitis B virus, or hepatitis C virus infection in Public Health Service increased risk donors. Am J Transplant 2019;19:2583–93; US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Bethesda, MD: US Department of Health and Human Services, National Institutes of Health, Office of AIDS Research Advisory Council. https://aidsinfo.nih.gov/contentfiles/adultandadolescentgl.pdf; Chung RT, Ghany MG, Kim AY, et al; AASLD-IDSA HCV Guidance Panel. Hepatitis C guidance 2018 update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection. Clin Infect Dis 2018;67:1477–92; Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology 2018;67:1560–99; Bowring MG, Holscher CM, Zhou S, et al. Turn down for what? Patient outcomes associated with declining increased infectious risk kidneys. Am J Transplant 2018;18:617–24; Croome KP, Lee DD, Pungpapong S, Keaveny AP, Taner CB. What are the outcomes of declining a Public Health Service increased risk liver donor for patients on the liver transplant waiting list? Liver Transpl 2018;24:497–504.

§ Source: CDC; Association of Public Health Laboratories. Laboratory testing for the diagnosis of HIV infection: updated recommendations. Atlanta, GA: US Department of Health and Human Services, CDC. https://stacks.cdc.gov/view/cdc/23447.

No recommendations in this category were substantially modified from 2013 to 2020.

Table 3.  

Donor or recipient Type of assay Timing of testing
Deceased donor
Anti-HIV and HIV NAT; total anti-HBc, HBsAg, and HBV NAT; anti-HCV and HCV NAT
96 hours before organ procurement
Living donor
Anti-HIV and HIV NAT; total anti-HBc, HBsAg, and HBV NAT; anti-HCV and HCV NAT
As close as possible to the surgery but at least within 28 days before organ procurement
Transplant candidate
(pretransplant)
CDC HIV testing algorithm*; total anti-HBc, HBsAg, and anti-HBs; anti-HCV and HCV NAT
Before transplantation during hospital admission for transplant
Transplant recipient
(posttransplant) HIV, HBV, and HCV NAT 4–6 weeks after transplant

Table 3. Testing recommendations for deceased and living donors and for transplant recipients, by type of assay and timing of testing

Abbreviations: anti-HBc = antibodies to hepatitis B virus core antigen; anti-HCV = antibodies to hepatitis C virus; anti-HIV-1/2 = antibodies to HIV-1/2; HbsAg = hepatitis B surface antigen; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; NAT = nucleic acid testing.

* Source: CDC; Association of Public Health Laboratories. Laboratory testing for the diagnosis of HIV infection: updated recommendations. Atlanta, GA: US Department of Health and Human Services, CDC. https://stacks.cdc.gov/view/cdc/23447.

Clinicians caring for liver recipients should maintain heightened awareness of the potential for delayed appearance of HBV infection and consider additional testing for HBV NAT at 1 year. Solid organ recipients who develop signs or symptoms of liver injury (e.g., jaundice or elevated liver function tests) after transplantation should be retested for viral hepatitis even if previous hepatitis B and hepatitis C testing was negative.

CME / ABIM MOC / CE

Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection — U.S. Public Health Service Guideline, 2020

  • Authors: Jefferson M. Jones, MD; Ian Kracalik, PhD; Marilyn E. Levi, MD; James S. Bowman III, MD; James J. Berger; Danae Bixler, MD; Kate Buchacz, PhD; Anne Moorman, MPH; John T. Brooks, MD; Sridhar V. Basavaraju, MD
  • CME / ABIM MOC / CE Released: 1/8/2021
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 1/8/2022
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Target Audience and Goal Statement

This activity is intended for organ transplant physicians, infectious disease clinicians, hematologists/oncologists, nephrologists, hepatologists, laboratory medicine practitioners, and other clinicians involved in organ transplantation.

The goal of this activity is to describe new recommendations for reducing transmission of HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) through organ transplantation, according to US Public Health Service updated guidelines.

Upon completion of this activity, participants will be able to:

  • Describe rationale and principles for use of new USPHS recommendations for assessing donors for HIV, HBV, HCV risk and monitoring recipients for transmission of these infections through organ transplantation
  • Identify key changes in the 2020 USPH guideline recommendations compared to the 2013 guideline recommendations
  • Identify other recommendations for assessing donors for HIV, HBV, or HCV risk, reducing the risk of transmission to recipients, and mitigating poor outcomes as a result of disease transmission according to the updated Guideline


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Authors

  • Jefferson M. Jones, MD

    Division of Healthcare Quality Promotion
    Centers for Disease Control and Prevention (CDC)
    Atlanta, Georgia

    Disclosures

    Disclosure: Jefferson M. Jones, MD, has disclosed no relevant financial relationships.

  • Ian Kracalik, PhD

    Division of Healthcare Quality Promotion
    Centers for Disease Control and Prevention (CDC)
    Atlanta, Georgia

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    Disclosure: Ian Kracalik, PhD, has disclosed no relevant financial relationships.

  • Marilyn E. Levi, MD

    Division of Transplantation, Healthcare Systems Bureau
    Health Resources and Services Administration
    Rockville, Maryland

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    Disclosure: Marilyn E. Levi, MD, has disclosed no relevant financial relationships.

  • James S. Bowman III, MD

    Division of Transplantation
    Healthcare Systems Bureau
    Health Resources and Services Administration
    Rockville, Maryland

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    Disclosure: James S. Bowman III, MD, has disclosed no relevant financial relationships.

  • James J. Berger

    Office of Infectious Disease Policy
    Office of the Assistant Secretary for Health
    US Department of Health and Human Services
    Washington, DC

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    Disclosure: James J. Berger has disclosed no relevant financial relationships.

  • Danae Bixler, MD

    Division of Viral Hepatitis
    Centers for Disease Control and Prevention (CDC)
    Atlanta, Georgia

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    Disclosure: Danae Bixler, MD, has disclosed no relevant financial relationships.

  • Kate Buchacz, PhD

    Division of HIV/AIDS Prevention
    Centers for Disease Control and Prevention (CDC)
    Atlanta, Georgia

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    Disclosure: Kate Buchacz, PhD, has disclosed no relevant financial relationships.

  • Anne Moorman, MPH

    Division of Viral Hepatitis
    Centers for Disease Control and Prevention (CDC)
    Atlanta, Georgia

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    Disclosure: Anne Moorman, MPH, has disclosed no relevant financial relationships.

  • John T. Brooks, MD

    Division of HIV/AIDS Prevention
    Centers for Disease Control and Prevention (CDC)
    Atlanta, Georgia

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    Disclosure: John T. Brooks, MD, has disclosed no relevant financial relationships.

  • Sridhar V. Basavaraju, MD

    Division of Healthcare Quality Promotion
    Centers for Disease Control and Prevention (CDC)
    Atlanta, Georgia

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    Disclosure: Sridhar V. Basavaraju, MD, has disclosed no relevant financial relationships.

CME Author

  • Laurie Barclay, MD

    Freelance writer and reviewer
    Medscape, LLC

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  • Hazel Dennison, DNP, RN, FNP, CHCP, CPHQ, CNE

    Associate Director, Accreditation and Compliance
    Medscape, LLC

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    Associate Director, Accreditation and Compliance
    Medscape, LLC

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Medscape, LLC staff have disclosed that they have no relevant financial relationships.


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CME / ABIM MOC / CE

Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection — U.S. Public Health Service Guideline, 2020

Authors: Jefferson M. Jones, MD; Ian Kracalik, PhD; Marilyn E. Levi, MD; James S. Bowman III, MD; James J. Berger; Danae Bixler, MD; Kate Buchacz, PhD; Anne Moorman, MPH; John T. Brooks, MD; Sridhar V. Basavaraju, MDFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME / ABIM MOC / CE Released: 1/8/2021

Valid for credit through: 1/8/2022

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Abbreviations

HBc = hepatitis B core antibody
HBsAG = surface antigen of the hepatitis B virus
HBV = hepatitis B virus
HCV = hepatitis C virus
HIV = human immunodeficiency virus
MSM = men who have sex with men
NAT = nucleic acid testing
OPTN = Organ Procurement and Transplantation Network

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