OPTN policy will align with the updated U.S. Public Health Service guidelines regarding donor screening for bloodborne disease transmission starting March 1, 2021. The new requirement for living donor specimen storage, and accompanying specimen storage consent, will go into effect on June 1, 2021. More details will be available soon.
At its November 2013 meeting, the Board of Directors resolved that as of February 1, 2014, OPOs must use the 2013 PHS Guideline for Reducing Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Organ Transplantation for evaluating behavioral risks related to disease transmission in living and deceased donors. The following information addresses commonly asked questions regarding use of the 2013 PHS Guideline.
Is my OPO or living donor recovery hospital still allowed to use the 1994 PHS Guideline?
No. Effective Feb. 1, 2014, the 2013 PHS Guideline (hyperlinked above; note the bulleted list on page 251) must be used for the medical-social evaluation criteria questions in evaluating all donors (both deceased and living) for increased risk for disease transmission, including HBV and HCV in addition to HIV.
Do I still need to note that I used the 2013 increased risk criteria for deceased donor evaluation in the Donor Highlights field in DonorNet® after February 1, 2014?
No. OPOs will not be required to document use of the 2013 Guideline in the Donor Highlights section of DonorNet® after the February 1 implementation date. The current Guideline is the only option for the evaluation of observed or behavioral risk factors for HBV, HCV, and HIV. If a donor meets increased risk criteria based upon the current PHS Guideline, OPOs denote this in a check box already provided in DonorNet®.
If a donor (deceased or living) is positive for HBV or HCV by antibody or nucleic acid testing, but does not meet any of the criteria for identifying a donor at increased risk for HIV, HBV, and HCV transmission, do I still classify the donor as an increased risk donor?
A donor should only be noted as “increased risk” when one or more of the PHS Guideline behavioral criteria to assess a donor’s risk for HIV, HBV, and HCV transmission are met. Presence of these behaviors indicate increased risk for transmission of these diseases.
If a donor has a positive antibody or NAT result for one of these diseases, but does not meet any of the PHS Guideline increased risk behavioral criteria, this donor should not be indicated as at increased risk of disease transmission.
A positive laboratory result for HIV, HBV, or HCV indicates known risk of transmission, and should be reported to all receiving transplant programs and OPOs as required in Policy 2.8 (Required Deceased Donor Information).
The PHS criteria for identifying increased risk behaviors and laboratory results should be considered as two separate categories:
- Increased risk based upon donor behaviors (carrying potential transmission risk)
- Confirmed risk based upon donor test results (carrying known transmission risk)
An OPO will not be compliant with OPTN policy if it reports a donor with a positive HBV or HCV lab result but no behavioral risks as outlined in the PHS Guideline criteria as an increased risk donor in DonorNetSM.
Should my updated medical-social questionnaire only include the new 2013 PHS Guideline criteria for determining increased risk for HIV, HBV, and HCV transmission at this time?
No. The PHS Guideline criteria for identifying donors at increased risk for transmitting infectious disease have historically been and should continue to be only a part of the medical/social evaluation of a potential organ donor. A great deal of information is collected during this evaluation that is important to transplant programs considering organ offers. This includes history of malignancy, history of travel outside of the United States, medications, smoking history, etc. All of this information remains important to the donor evaluation process.
The “increased risk” designation is meant to specifically indicate increased risk of transmission of HIV, HBV, and HCV based on observed or behavioral risk factors associated with these infections. There are, of course, other issues that are important for transplant programs and potential recipients to consider in addition to these specific viruses. Continuing to collect this information is important and must be continued per Policy 2.4 (Deceased Donor Medical and Behavioral History).
My OPO uses combined nucleic acid testing (NAT) for donor evaluation. How do I record these results?
If your OPO is already using NAT, these results should be recorded in the “Donor Highlights” section in DonorNet®. This practice is recommended until NAT data fields are programmed in DonorNet®.
The Ad Hoc Disease Transmission Advisory Committee recognizes that duplex and triplex NAT is used by some OPOs for donor evaluation. DonorNet® will be programmed to collect individual HIV, HBV, and HCV NAT results for a donor.
If the multiplex test result is negative, a negative result for all viruses included in a particular test should be noted in DonorNet®.
If a multiplex test result is initially positive, results should be noted as pending in DonorNet® until individual confirmatory NAT results are received to distinguish which virus is present in the donor.
My OPO/living donor recovery hospital wants to continue to use the five-year time period when posing the increased risk criteria questions instead of the one year time period outlined in the 2013 PHS Guideline. Tissue donor evaluation still requires the question to be posed for a five year period previous to donation. Is it acceptable for meeting policy requirements to ask for five years?
Assessment of potential tissue donors requires medical-social evaluation for the preceding five years. The new PHS Guideline for potential organ donors shortens this period to the preceding 12 months. OPOs may pose the required questions to determine if an individual has met any of the increased risk criteria within the last five years.
- If the answer is no for the last five years, then this would be sufficient for the purposes of both organ and tissue donation.
- If the answer is yes, a follow-up question must be posed to determine if the behavior or activity in question has occurred within the last twelve months. This follow-up question will meet OPTN policy requirements for organ donor evaluation. Any information learned regarding risks within the last five years should still be shared as part of the medical-social history.
If a potential pediatric donor has been breastfed within the last year, should a full medical-social evaluation be completed for the mother (if she is available), or are only the increased risk criteria questions required?
The OPTN has no specific policy requirement regarding breastfed donors, but the Ad Hoc Disease Transmission Advisory Committee supports the PHS recommendation as a best practice for OPOs. Recommendation 4 in the PHS Guideline (Risk Assessment (screening) of living and deceased donors) notes that, if available, the mother should be interviewed about behaviors that may have placed her at risk for HIV, HBV, or HCV infection.
If a potential deceased donor has had dialysis in the last year, is he or she an increased risk donor?
Yes. The last of the eleven medical-social criteria in the 2013 PHS Guideline applies only to define whether a donor is at increased risk for recent HCV infection: People who have been on hemodialysis in the preceding 12 months.
Based upon questions from a number of OPOs, the Ad Hoc Disease Transmission Advisory Committee took this question to CDC staff for discussion. The Committee recognized the HCV risk related to chronic dialysis as part of long term care, but noted that some deceased donors require dialysis only as part of their terminal hospitalization that leads to organ donation. The risk of transmission is tied to the equipment used for dialysis, not the length of time someone receives this treatment. In some hospitals, potential organ donors may receive a dialysis treatment on a portable machine that is also used elsewhere in the hospital for individuals receiving long term dialysis, potentially raising the risk for HCV exposure. For this reason, any donor on dialysis within the last 12 months should be noted as at increased risk for HCV transmission. This risk should be explained to potential transplant recipients and their families.
If a potential deceased donor is receiving CVVH during the terminal hospital stay, is this to be treated as an increased risk in the same way that dialysis is?
Continuous veno-venous hemofiltration (CVVH) is also used in the ICU to treat acute renal failure as part of a donor’s terminal hospital stay. This treatment uses different machinery than that used for dialysis. The risks for HCV transmission in this setting would be negligible, since no known disease transmission events related to transmission specifically by CVVH have been published in the literature. These individuals should not be classified as at increased risk for HCV transmission.
The DTAC is concerned that OPOs may not be aware of the distinction between CVVH and dialysis during evaluation and may potentially identify these patients as at increased risk for disease transmission. This could be very misleading to transplant hospitals, candidates and their family members considering these organ offers.
On February 1, 2014, is my OPO or transplant hospital required to test donors and recipients as outlined in the PHS Guideline recommendations?
No. The recommendations within the Guideline are separate from the medical-social evaluation criteria. The February 1, 2014, implementation date only requires use of the updated evaluation criteria within the Guideline to identify increased risk donors through observed or behavioral risk factors using that now include HBV and HCV in addition to HIV. (These criteria can be reviewed in the bulleted list that begins on page 251 of the PHS document, linked above.)
The 2013 PHS Guideline also includes 34 recommendations (and sub-recommendations) that cover a wide variety of topics, including candidate, donor, and recipient testing, informed consent, specimen collection, and storage. These recommendations also begin on page 251 of the PHS document as numbered items under the header “Risk assessment (screening) of living and deceased donors.”
The OPTN Ad Hoc Disease Transmission Advisory Committee developed a proposal that it plans to release for public comment in March 2014. This document proposes modifying OPTN transplant policy to include some of the 2013 PHS Guideline recommendations. It should be noted that a number of these recommendations are already included in current OPTN policy or are best practices within the transplant community. OPTN public comment proposals may be reviewed at: http://optn.transplant.hrsa.gov/governance/public-comment/.