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Align OPTN Policy with U.S. Public Health Service Guideline, 2020

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What is current policy and why change it?

In June 2020, the U.S. Public Health Service (PHS) updated the Guideline for assessing solid organ donors and monitoring transplant recipients for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection due to improved testing and risk assessment methods. The OPTN must change its policies to be consistent with the updated Guideline.

Align OPTN Policy with U.S. Public Health Service Guideline, 2020

Dr. Marian Michaels, past Chair of the Ad Hoc Disease Transmission Advisory Committee, reviews the policy proposal to Align OPTN Policy with the 2020 U.S. Public Health Service Guideline.

Terms you need to know

  • Hepatitis B Virus (HBV): Hepatitis B is a vaccine-preventable liver infection caused by the hepatitis B virus (HBV).
  • Hepatitis C Virus (HCV): Hepatitis C is a liver infection caused by the hepatitis C virus (HCV).
  • Human Immunodeficiency Virus (HIV): Human Immunodeficiency Virus (HIV) is a virus that attacks the body’s immune system. If HIV is not treated, it can lead to Acquired Immunodeficiency Syndrome (AIDS).
  • U.S. Public Health Service (PHS) Guideline: Updated in 2020 from the 2013 revision, the Guideline provides recommendations for organ transplantation related to Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV).

Click here to search the OPTN glossary

What’s the proposal?

  • Remove terms that label an organ donor “increased risk” in OPTN policy.
  • Shorten the length of time organ donors with risk criteria would be considered for acute HIV, HBV and HCV from 12 months to 1 month.
  • Remove medical and social donor risk criteria that have not been associated with risk of organ donor transmission of HIV, HBV, and HCV.
  • Add testing for all transplant recipients at 4-8 weeks post-transplant for HIV, HBV, and HCV.
  • Add liver recipient testing at 11-13 months post-transplant for HBV.
  • Remove requirement for separate recipient informed consent to accept an organ from a donor that meets any risk criteria. Promote patient education and require providers to inform candidates if the donor has any risk criteria.
  • During candidate evaluation, add a requirement to assess the need to provide HBV vaccination. Add requirement to report vaccination status.
  • Require transplant hospitals to store pre-transplant living donor samples for 10 years. This aligns with current policy for deceased donor samples.

What’s the anticipated impact of this change?

  • What it’s expected to do
    • Increase number of transplants and minimize risk of transmission of HIV, HBV and HCV
    • Provide a framework for discussion of risks and benefits of accepting and declining organs from donors with risk criteria for acute HIV, HBV, and HCV infection
    • Promote early identification and treatment for HIV, HBV and HCV
  • What it won’t do
    • This will not eliminate the need to inform candidates that organs have risk criteria for HIV, HBV, and HCV transmission
    • This will not eliminate the absolute risk of disease transmission events

Themes to consider

  • Potential changes to organ use
  • Length of time required for living donor sample storage
  • Removal of hemodilution as a risk criteria
  • Feasibility of collecting additional data related to HBV vaccination status

Provide feedback

Overview

Status: Public Comment

Sponsoring Committee: Ad Hoc Disease Transmission Advisory Committee

Strategic Goal: Increase the number of transplants

Contact:

Pete Sokol; Kristine Althaus

Comments

Anonymous | 08/05/2020

I am writing this both as a transplant surgeon, as well as a medical director of an OPO. The current standards of classifying donors as "high risk" has hurt the transplant system in my opinion. The current classifications are so broad, that almost 40% of donors now meet this criteria. All donors get NAT testing now, reducing the window period of infection. These criteria need to be tightened to mirror reality of infections, given current testing. From a transplant surgeon perspective, I can honestly say that I have had patients turn down organs specifically because they were told they were "high risk" and refused to sign a consent, choosing to wait for something "better". This is despite the fact they are told about the different organs they may be offered when they were listed. I believe that patients already have a lot of information to digest while learning about a transplant. Pushing them to consent for a supposedly "high risk" organ at the time just before transplant is wrong, and adds additional stress and pressure on them. Mandating this consent (which makes it look more serious) has only hurt us.

Amit K Mathur MD MS FACS | 08/14/2020

This proposal is long overdue. This policy will help assayed patient and provider concerns about infectious risk transmission through transplant by reducing the “labeling” effect, will likely lead to increased utilization of these currently “labeled” organs, and reduce compliance regulatory burden for transplant centers around special consents, non-uniform consenting processes for patients, and so on. I strongly support this proposal.

Steven Potter | 08/17/2020

Oppose as written, support with amendment. I am in full support of several of the goals of this proposal, namely to increase transplant recipient safety and to move OPTN policy in to alignment with the generally cogent and well-intended revisions to CDC guidance on PHS IR donors and related issues. However, the portion of the proposal seeking to mandate collection of sera for NAT and serology (two samples) from every living donor, and the requirement that the transplant center at which that living donor surgery is performed store that blood for 10 years is problematic. The primary concern is that collecting these samples from living donors seems to violate the sanctity of stewardship and protection of the living donor. This policy, as written, essentially mandates establishing living donor biorepositories all over the country. The potential ramifications of this for the living donor, and the concerns that potential living donors may have in this regard, have not been considered in a public (or private) forum. The corollary to this actual and potential burden on living donors is that it seems unreasonable under any scenario to posit benefit to anyone by keeping living donor serum in storage for a decade. Which donor derived infectious disease would rear its head in a recipient 9 years after the transplant was performed? If the answer is that it could be things yet discovered and unearthed with as yet untested or unknown assays, then again, what framework provides for consent and protection for all the downstream potential ramifications for living donors? Once the issues of ethics, protection of living donors and stewardship are addressed, we are left with pragmatic concerns. Storing living donor samples for ten years will be logistically challenging for transplant centers, and will impose logistical, capacity, record keeping and personnel costs for no potential benefit. This will consume resources that would be better used to increase the numbers of transplants performed and increase the quality of transplant care provided. I would advocate for amending the proposed policy by simply removing the requirement for storage of living donor samples. The rest of the policy is actionable, its costs to stakeholders are offset by potential benefit, and it is a step in the right direction.

Beth Israel Deaconess Medical Center | 08/19/2020

Although we support this policy proposal for the most part, we object strongly to the living donor sample storage requirements. Our center is concerned that the requirement for is not well defined and will require a significant resource by transplant centers. We have the following questions: 1) What type of specimen is needed for 10 year storage? ‘Blood’ is a vague term from a laboratory standpoint. Is it whole blood/serum/plasma/buffy coat? 2) What volume/quantity is needed to be stored? 3) What storage conditions (is -20C or -70C or Liquid nitrogen)? 4) Most importantly, what is the specific rationale for 10 years of storage. Without clarification, we cannot support this part of the proposal.

William Pelley | 08/20/2020

While I support the effort to create a safer system for recipients, I am concerned with the testing requirements for recipients. Having to do NAT testing on a 3 month old prior to transplant and in the post transplant timing just does not make any sense to me. I am unaware of any babies getting an infectious disease from a transplant. That aside why would we test again when the donor was negative and the pre-transplant testing was also negative. The burden on transplant centers for post testing will be difficult for larger centers and also does not make sense if both the donor and pre-transplant recipient testing indicate a negative result. This seems to be a solution for a problem that does not exist particularly in the pediatric world.

Angele Lacks | 08/20/2020

I am commenting as both a kidney transplant coordinator and a living kidney donor. From the donor aspect, I would have had no issue with NAT and serology testing twice before transplant. I also don't believe it would be a difficult task to complete. I am also in favor of keeping pre transplant samples from the donor for a period of time in the event something unforeseen occurs. I do not favor holding the sample for 10 years. I personally don't see the benefit. As a transplant coordinator, I highly support changing the increased risk labels. When I call a recipient with an offer they are typically so taken aback, that they only hear part of what is being explained to them. Often the term "increased risk" is taken to mean the kidney may not last as long. I think removing some of the criteria would help make the offer process less overwhelming and easier for the recipient to digest. I also think that keeping the donor samples for 10 years would be very burdensome and costly for the transplant centers.

UC San Diego Center for Transplantation, CASD | 08/20/2020

CASD strongly supports the OPTN’s efforts to better align existing policies with the recommendations for mitigating the risk of acquiring human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C (HCV) through organ transplantation issued by the Public Health Service. While the testing of organ donors and follow-up of transplant recipients to prevent the spread of infectious diseases should remain a core component of transplant related care, we have long been of the opinion that the requirement to obtain an additional consent from candidates to proceed with an organ identified as increased risk resulted in a disproportionate number of organ declines based on fear rather than fact. Additionally, we are hopeful that the collection of this additional data will lead to further refinement of related policies and guidelines and improvements in patient care. We would however, ask that the Committee seriously consider the impact of potential case delays, particularly in the setting of rapid DCD, if it is the Committee's intent to require testing be resulted prior to procurement, rather than advising it be resulted prior to transplant as it was in the 2013 version of this policy.

Sanjay Kulkarni | 08/20/2020

OPO's also use "increased risk" terminology in designating specific donor characteristics. This probably should be addressed if the aim is to de-emphasize the term "increased risk"

David Bearl | 08/20/2020

There are a few key points that I think this proposal attempts to achieve. 1) It recognizes that the risk of these particular blood-borne pathogens is actually quite low, especially in comparison to many of the inherent risks of solid organ transplantation, 2) It demonstrates that language matters such that adding "increased risk" makes a substantive difference, especially in the minds of a recipient or their family, 3) It helps to collect more information that the transplant community might understand the factors that are present to make a donor supposedly higher risk. While there appears to be some confusion in regards to the consent process, I think this proposal actually improves the autonomy of the recipient by allowing them to make a more informed decision through a consolidated consent process (i.e. understanding that all donors come with risks and these specific blood-borne pathogens are only a select few, and with a relatively rare chance of transmission). In regards the concept of an increased risk donor, I think that understanding why a donor is labeled as such is important information for the OPOs to collect, both to better understand donor-recipient interactions but also to better assess what truly makes a donor higher risk. I support this proposal.

palv | 08/21/2020

Support IF revised in 2 areas, as follows: 1. Living donor serum is not currently stored by our center. Lymphocytes are frozen and stored for 6 months, then discarded as no longer viable. Strongly agree w Dr Potter that living donors are not volunteering to have their serum retained for 10 years in furtherance of uncertain goals. As they are still living, if future specimens are appropriate in search of transmissible diseases, the living donor will likely be alive and able to appropriately consent to donating a serum (or other type of) specimen for investigation. I would ask that the Committee withdraw any request to mandate storage of living donor material above and beyond clinical needs. 2. Hepatitis B vaccination has been recommended for US children and adults for over 20 years and lack of a strong public health commitment in the US has led to low vaccination rates. Transplant centers are not Public Health centers. Assessing hepatitis B status pre-transplant is clinically necessary and appropriate. The responsibility to vaccinate is not that of the transplant center. Also, the pre-transplant morbid status deeply effects the success of vaccination (best documented in dialysis patients), and is a suboptimal time to vaccinate. I would ask the Committee to delete the 2nd sentence in the paragraph with lines 191-196, which implies a transplant center responsibility to deal with hepatitis B naive candidates.

Steven Potter | 08/25/2020

Given a negative deceased donor NAT, the likelihood of disease transmission (HIV, HCV, HBV) to the recipient is roughly one in a million (Source, DTAC presentation to MPSC, 8/20/2020). We do roughly 23,000 deceased donor kidney transplants a year in this country. We would need to transplant patients for over 40 years to get one true positive test result. So, this policy proposes to require transplant programs to test every recipient despite the vanishingly low likelihood of a positive test due to the transplant? I am concerned that the significant resources needed to obtain all these negative tests, enter, store, and access the data, and make that data available for surveyors could be better spent advancing the strategic initiative of transplanting more patients in need. The community may need clarification on that.

Region 4 | 08/26/2020

Region 4 vote: 1 Strongly Support, 11 Support, 2 Neutral/Abstain, 6 Oppose, 4 Strongly Oppose Region 4 had mixed support for this proposal. During the discussion several attendees opposed keeping living donor blood for 10 years. The concerns were around cost, capacity, logistics and legal challenges. One of those who commented did not agree that donor derived infectious diseases would appear in recipients years after the transplant. Another attendee commented that the post-transplant testing requirements are too laborious and unnecessary and would result in a huge stress on the transplant system. One attendee recommended that there should be consideration of small pediatric recipients, where the drawing of ID labs can significantly add to anemia due to the blood volume required for many of these labs. They added that pediatric donor risk profiles are much different than adult donors, thus the risk for donor derived infections is significantly lower. One attendee opposed the HBV vaccination mandate commenting that vaccination status is a responsibility of the clinical team and assessed during evaluation not for regulatory policy. There was a comment that the OPTN should annually post transmission rates for each infection and organ to facilitate risk specific consent at offer. One commenter recommended that the requirements of PHS Guidelines versus requirements added due to DTAC judgement or goals need to be categorized clearly identified. They also added that while some requirements of the policy are directly from PHS, there are items (i.e. live donor sample storage or OPO draw/storage within 24 hours of recovery) that create burden for members and policy oversight challenges for UNOS/OPTN and the MPSC. One member had concerns about the 96 hour time period and recommended greater flexibility for donor cases when there are long delays between initial sample collection and actual recovery. There was also concern from some attendees about adding HIV, HBV, and HCV testing for all transplant recipients after admission for transplant and before anastomosis. Their comments were that this adds more cost than value and the status is already assessed during evaluation. There was also an attendee who was not supportive of testing for all transplant recipients at 4-8 weeks post-transplant for HIV, HBV, and HCV and opined that post-transplant testing is a clinical decision not for regulatory policy. Another attendee opposed liver recipient testing at 11-13 months post-transplant for HBV. Finally, an attendee opposed the requirement that living donor recovery hospital must obtain specimens appropriate for serological and NAT testing within 24 hours prior to organ recover, noting that this status is already assessed during evaluation, and within 28 days of recovery.

Region 5 | 08/28/2020

Region 5 vote: 9 Strongly Support, 16 Support, 4 Neutral/Abstain, 3 Oppose, 0 Strongly Oppose. Region 5 supported the proposal and had the following comments: • Several attendees opposed keeping living donor blood for 10 years. Poses cost, capacity, logistics and legal challenges. • The requirement to re-draw infectious disease samples on longer cases could adversely affect transplant • This is a good step forward. It will be easier to counsel patients about the known and the unknown risks of every transplant. I think that the 10 year holding period for living donors is a bit long, especially since most living donors are still around 10+ year later and no deceased donors are still around. • Request that in policy please outline requirement for scenario of delayed OR times and the requirement for the 96 hours draw time for serologies. • Pre-transplant labs on small pediatric patients not at risk of HBV, HCV, or HIV, and who have previously been tested, are unnecessary and may pose risk with blood loss to the patients. We would support a carve out of these requirements for small recipients under 10-12kg. Regarding vaccination protocols, some pediatric patients have not had vaccines per their routine care, and vaccination may be contraindicated in some very ill pediatric patients. This needs to be accounted for in the policy. • Amend guidelines where appropriate for young pediatric recipients. • Strongly support changes to donor risk criteria and consent. However, disagree with: young children (<5 years old, <20kg) likely have a very low risk of getting HIV, Hep B or Hep C between transplant evaluation and transplant--retesting at the time of transplant is unnecessary--and not an appropriate reason to draw blood especially in small children as it presents some risk to them. • I think this policy requires additional discussion before we formally change policy. Even though we support the goal to align OPTN policy with the PHS guidelines, we're not supportive of the portion relating to long term storage of live donor samples, without additional discussion, and clarification of live donor informed consent. Not sure of the purpose of long term storage of live donors compared to the potential risk associated with disease transmission in a donor who was NaT - prior to surgery. Some centers may not have capacity to require lab to manage long term storage of samples. Maybe this won't be a problem, but I think hospitals need to be given time to more clearly understand if these requirements would be a problem for their facility. We really like removal of informed consent relating to the disease transmission risk. We can include this in our current pre listing informed consent without being mandated by a policy. • Support easing back the restrictions. We think consenting is still required based on the presentation. We agree with decreasing the time required for storage of pre recovery blood. This is a large administrative burden for unclear (at least to us) yield. Eliminating hemodilution from PHS is acceptable but continue to elevate attention to indeterminate blood type on policy on such for hemodilution is warranted (as alluded to in the presentation). • Hemodilution and HD should remain risk. • OPTN policy must be consistent with PHS guidelines. Strongly support with amendment to remove the requirement for storage of living donor samples for 10 years. Oppose as written. • Concerns about the number of samples that an OPO may be required to obtain. 1. For initial testing, 2. If the O.R. will be more than 96 hours later (what if the O.R. gets postponed and then we have to get the sample and postpone the O.R. further). 3. 24 hours before the O.R. for storage. This blood would have to be processed and stored differently than the one initially used for testing. This feasibility is difficult at best. • Removal of hemodilution is an excellent change. • Requiring documentation of the HBV immunity status is an excellent change as well as vaccination status and barriers to completion. The vaccine is of proven efficacy so barriers to implementation of this intervention is essential to understand. • To evaluate the effectiveness of the PHS Guideline, the committee would benefit from clarifying if the intent of the OPO reporting additional specific risk criteria is information transfer vs data capture. All of the relevant risk criteria exists in the donor's DRAI and is therefore reported to the transplant centers. If the goal is data capture then we should consider incorporating the DRAI into DonorNet.

Ethics Committee | 08/31/2020

The OPTN Ethics Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for its effort in developing the Align OPTN Policy with U.S. Public Health Service Guideline, 2020 public comment proposal. The Committee expresses its support regarding the creation of a comprehensive informed consent process that promotes patient autonomy and supports their decision-making by contextualizing the donor attributes designated as “increased risk.” The Committee believes that providing more information about the various risk factors associated with all organs will increase the utility and placement of those previously labeled “increased risk.” The Committee expresses its concerns regarding the implementation of the revised consent process, specifically how risks are communicated with patients. The Committee wants to ensure patients are adequately aware of what they are consenting to and are empowered to make an informed decision when assessing the risks and benefits of accepting or declining specific organs. In addition, the Committee expresses concern that the requirement to store living donor recovery specimens for ten years may create a barrier for potential living donors, especially minorities, who may be hesitant to consent to this practice because of institutional distrust. The Committee members indicated 62.5% strongly support and 37.5% support.

OPTN Pediatric Transplantation Committee | 09/01/2020

“The Pediatric Transplantation Committee thanks the Ad Hoc Disease Disease Transmission Advisory Committee for their efforts in crafting this policy proposal to align OPTN policy with the updated PHS guidelines and appreciated the opportunity to provide feedback. The Committee strongly supports the proposal and feels that the proposal has the potential to increase organ transplants and save additional lives. The Committee feels that these changes will help take away the stigma of these organs when accompanied with universal testing. The Committee feels strongly that there should be a strong emphasis on education as it will be an important component to helping patients and parents of pediatric patients understand the associated risks. Particularly for the younger children (<3 years old) and severely ill children, re-testing for HIV, Hepatitis B or Hepatitis C virus could be a significant blood volume in VERY low risk transplant candidates. We recommend that the Committee consider adjusting the requirement so that testing within 6 months, or within 6 months unless the pediatric candidate has had higher risk events since last testing would be more appropriate for pediatric transplant candidates. The Committee sentiment vote was unanimous in favor of ‘strongly support’ for the proposal. “

OPTN Kidney Transplantation Committee | 09/01/2020

The OPTN Kidney Transplantation Committee appreciates the opportunity to comment on this proposal and appreciates that leadership of the OPTN Disease Transmission Advisory Committee took the time to present the finer points of this proposal to our members. The Committee strongly supports this proposal and believes that updates to critical nomenclature will represent positive improvements system-wide.

OPTN Transplant Coordinators Committee | 09/02/2020

The Transplant Coordinators Committee is in support of the goals of this proposal and the effort to align existing policies with the most up to date Public Health Service (PHS) recommendations for mitigating the risks of acquiring HIV, HCV and HBV through organ transplantation. However, the committee expressed concerns regarding a few components of the proposal: the additional collection and storage requirements for living donor recovery hospitals, the requirement that NAT testing result prior to procurement, and the requirement that transplant centers report HBV vaccination status. The development of biorepositories for living donor samples may be logistically challenging for transplant centers, and it is not clear what type of consenting will be required for living donors given that the sample will be banked for a decade. The rationale for requiring 10 years of storage was not clear to committee members. The TCC recommends that the requirement for NAT testing to result prior to procurement be assessed to determine how this requisite might impact expedited cases such as rapid DCD donors. Lastly, committee members did not feel that it is the responsibility of the transplant center to vaccinate or track vaccination status for HBV. This requirement could potentially become a documentation burden for transplant centers, especially large volume programs. While we largely support the primary goals of this proposal, it is our recommendation that the living donor sample storage be revisited, that the requirement for serological testing to result prior to procurement be further assessed, and that the HBV vaccination requirement be removed. VOTE: 1 Strongly support, 10 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Christina Klein | 09/02/2020

Support the proposal with 2 significant exceptions 1) storage of LD specimens for 10 years. Rationale and data to support this has not been provided. Brings up issues of consent, additionally appears low yield and logistically very challenging with excessive resource burden on transplant centers 2) requirement to document barrier to vaccination in a HBsAB negative candidate. This places an undue burden of documentation on a transplant center particularly those with large waitlist. Agree that transplant centers should assess HBV immune status in candidates in order to facilitate transplants per center protocols. For example, if offered a HBcAB positive, surface Ag/NAT negative donor, the transplant center can opt to NOT transplant that donor organ into a HBsAB negative recipient.

Avera | 09/03/2020

Oppose as written. Specific concerns: The storing of donor blood for 10 years poses multiple problems: patient privacy concerns to the point of potentially discouraging donation, transplant center burden and cost, questionable usefulness. I would propose that there would be little to no utility to obtaining post transplant HIV, HBV and HCV testing on recipients of donors who tested negative and had no PHS risk factors. Finally, the burden around HBV vaccination is huge. Transplant centers would need to obtain vaccination history from dialysis units which are mandated to vaccinate independent of transplant candidacy. For non-dialysis patients transplant centers have little control over vaccinations and can only educate candidates. Transplant centers cannot be expected to administer a 3 dose vaccination to candidates who often live a long distance form the transplant center.

OPTN Pancreas Transplantation Committee | 09/03/2020

The Pancreas Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for the opportunity to review their Align OPTN Policy with U.S. Public Health Service Guideline, 2020 public comment proposal. The Committee provided the following feedback: • The Committee inquired if there have been instances, within the last several years, of a documented infection within the two weeks of a negative NAT test that would require a center to go through the expense and effort of storing blood just in case. It was explained that the NAT test requirement for living donors is a month before transplant and there have been instances where a recipient contracted Hepatitis B/Hepatitis C and it couldn’t be known if it was from the donor. • The Committee expressed concern about who would be responsible for storing the blood sample of the living donor. It was explained that a transplant center isn’t going to have a freezer to store this sample, so this responsibility will probably fall to the HLA lab. It was recommended that this proposal be presented to the Histocompatibility Committee. • The Committee inquired whether this proposal was mandating vaccination for Hepatitis B. It was stated that this policy does not mandate vaccinations; however, it does mandate the assessment of the need for a vaccination and the subsequent discussion with the patient. • The Committee inquired about the rationale for the 10 year time requirement for storing living donor samples. It was explained that this was to reflect the storage time requirement for deceased donor samples. The Committee proposed a modification to the 10 year living donor sample storage requirement and suggested that 5 years may be more reasonable than 10 years. The Committee indicated the following sentiments for the proposal: 6 Strongly Support; 5 Support; 0 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose.

Region 7 | 09/10/2020

Region 7 vote: 8 Strongly Support, 7 Support, 1 Neutral/Abstain, 1 Oppose, 0 Strongly Oppose Region 7 supported the proposal and had the following comments: • One attendee commented that they strongly agree with changes to PHS increased risk and making this more granular and less binary. They added that the committee should look carefully at the other parts of the proposal and determine whether they are within the purview of the OPTN and if they have unintended consequences or expense that is out of proportion to the benefit. • Three attendees expressed being opposed to the 10-year storage of living donor samples. They commented that it can be difficult and costly. They suggested storage of living donor samples be dropped to 1-5 years. Another attendee commented that living donor storage may create a barrier to living donation, could have legal ramifications, and be costly. The attendees that commented, agreed that 10 years was excessive. • One attendees expressed concerns around HBV testing and vaccination. It was also recommended that (DTAC) review possible policy language concerning data collection related to HBV vaccination status of transplant candidates to help transplant programs reduce variability in how this is interpreted and how HBV immunity is measured. • Two attendees commented that hemodilution should be removed. • An attendee concurs with the recommendation that liver transplant recipients should undergo HIV, HBV, and HCV NAT testing at the proposed intervals: 4-8 weeks post-transplant and HBV NAT testing at 11-13 months post-transplant. • One attendee added that the language referring to "increased risk" concerning social indicators on the donor side should be eliminated due to established and effective donor NAT testing protocols that are in place, the low chance of infection when tested NAT, and the direct acting antiviral therapeutic options that are available. OPOs will need training and guidance to implement this policy effectively. • An attendee suggested to keep the increased risk button in Donor Net for data purposes and leave "results at time of transplant" language the same

Histocompatibility Committee | 09/10/2020

The Histocompatibility Committee is overall supportive of the proposal to align OPTN policy to the 2020 PHS Guideline. There are no major concerns. Committee Vote: 4 strongly support, 11 support, 1 neutral, 0 oppose, 0 strongly oppose

Transplant Administrators Committee | 09/10/2020

The OPTN Transplant Administrator Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for inviting feedback on the Align OPTN Policy with U.S. Public Health Service Guideline, 2020 public comment proposal. The Committee understands the importance and supports the intention of the proposal as the members share the mission of increasing the utilization of organs while providing the highest quality of care to transplant candidates and donors. However, the Committee expresses its concerns regarding the requirement to store living donor specimens for ten years as there will be a need to establish new procedures and potentially procure additional equipment or arrange for storage to accommodate this process. In addition to concerns around patient privacy issues, storing these samples may cause programs to incur additional expenses. There may be financial burden on transplant programs and/or patient to conduct HIV, HBV, HCV tests post-transplant. Since the tests are not currently required for asymptomatic recipients, it is possible the costs may not be reimbursed to centers by payers. Current diagnosis codes do not allow for 'screening' without cause for HIV, HBV, and HCV infection. This could pose a financial burden to the patient, which could inhibit testing compliance as well as increased staffing and financial burden to transplant programs. Collection of HBV vaccine documentation from patients may be a staff burden. The Committee suggests providing HBV immunity status as the source documentation, allowing for the candidate’s clinical team to assess the need for vaccination without being obliged to track or report on vaccine documentation from the patient’s medical history.

Region 3 | 09/15/2020

Region 3 vote: 6 Strongly Support; 15 Support; 0 Neutral/Abstain; 4 Oppose; 0 Strongly Oppose: Comments: Feedback was provided that the requirement to store specimens for 10 years is excessive and would add substantial resource demands and for living donors would also require informed consent. Feedback was also provided by several people that it should not be the transplant program’s responsibility to document why HBV vaccination has not been completed because that should be done by the dialysis center or nephrologist and because it is not clinically relevant in light of the rarity of transmission. One member stated that hemodilution as a risk factor should not be removed because of the problems associated with testing. Additional comments submitted online during meeting: • While in support of this policy related to monitoring all recipients at 1-2 months post-transplant, and liver recipients again at 11-13 months, with deletion of a separate consent form while continuing education of the candidates/recipients, we do not support the current proposal's inclusion of 1) storing living donor specimens for 10 years and 2) assessing/documenting all candidates' HBV vaccination between evaluation to organ offer. • I do not agree with the details regarding documenting Hep B vaccinations. That should not be a mandate to the transplant centers. Living donor samples should not be saved more than two years; the proposal for ten years is an unacceptable burden and a logistics nightmare for transplant centers. • This is long overdue, thank you. • Do not feel having to document all HBV vaccination of patients on the kidney waitlist is feasible. I would suggest the OPTN address HBV vaccinations of dialysis patients with CMS. This would help get all of the information caught up on the waitlisted patients. • Hemodilution must stay as a risk factor. Critical on ABO and ID serologies. • Not helpful or reasonable to ask renal recipients to document HBV vaccination status - too many patients, too many dialysis units with varying record access, and once we've checked serologies we have relevant allocation strategies. Furthermore, there is no meaningful hepatitis B transmission through kidney transplants - I've been at high volume centers with aggressive strategies for 15+ years and have never seen a case of HBV transmitted to a kidney recipient. • All patients are at some type of risk, why do we need to label them in anyway, all this information should be clearly listed within the organ offer to allow a transplant center to make decisions based on the information.

Membership & Professional Standards Committee (MPSC) | 09/15/2020

The MPSC thanks the DTAC for presenting its proposal “Align OPTN Policy with U.S. Public Health Service Guideline, 2020” and offers the following questions and comments: • Deceased donors must be tested using samples collected within 96 hours before procurement. If the collection time eventually falls outside of that timeframe, would the OPO have to collect samples and repeat testing? If testing has to be repeated, would the OPO have to hold the donor O.R. until the results from the repeated tests are returned? Repeating testing could lead to interpretation and allocation issues if the two sets of results do not agree. DTAC should consider the policy language and guidance regarding repeat testing vs. confirmatory testing, and what to do if tests are re-run and return conflicting results. • According to the proposal, the specimens for archiving must be collected within 24 hours before procurement. Why can’t the same specimens used for testing [within 96 hours before procurement] also be used for archiving? • Why is testing all recipients for HIV, HBV, and HCV required, given the extremely low risk of transmission after universal donor nucleic acid testing? This would impose a significant burden on both transplant hospitals and patients. Transplant recipients will have to deal with the uncertainty and emotional stress of getting additional, relatively unnecessary testing and then waiting for the results. • Archiving blood from living donors will cause significant increased cost and workflow for transplant hospitals. For example, transplant hospitals don’t have a mechanism to counsel and consent living donors about donating blood for possible future use. It will impose a burden on the donors, who will have to provide blood for storage, and it seems to violate the protection of living donors and the sanctity of their gift of life. • Does DTAC have a specific timeframe in mind for testing candidates for HIV, HBV, and HCV during hospital admission for transplant but before transplant? The current language could be interpreted a number of ways. • The hemodilution calculation may not be necessary for HIV, HBV, and HCV nucleic acid testing, but the information is valuable in the lab for interpretation and other assessments and should not be removed entirely from policy. The results of the MPSC’s sentiment vote are 7 Strongly Agree; 19 Agree; 3 Neutral/Abstain; 1 Oppose; and 1 Strongly Opppose.

OPTN Vascularized Composite Allograft Transplantation Committee | 09/18/2020

Vote: 0 Strongly Support, 5 Support, 1 Neutral/Abstain, 2 Oppose, 0 Strongly Oppose The Vascularized Composite Allograft (VCA) Transplantation Committee appreciates the opportunity to comment on this proposal. Members felt this proposal offers great improvement but had some concerns about the breadth of the testing requirements, which may confer more cost than value. Members also had concerns about the timeline for storing living donor samples for transplant centers that do not have that capacity already.

Living Donor Committee | 09/21/2020

The OPTN Living Donor Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for inviting feedback on the Align OPTN Policy with U.S. Public Health Service Guideline, 2020 public comment proposal. The Committee supports the overall effort to align OPTN policy with updated PHS guidelines. The Committee is concerned that the requirement to store living donor recovery specimens for ten years puts an undue burden on programs and recommends modifying that requirement. The Committee suggests evaluating data from long term living donor transmissions to determine the appropriate duration of sample storage. The Committee also thinks living donor privacy concerns should be considered and requests more detail on who would be required to facilitate storage and the legalities of access to those samples. If living donor sample storage is required, the Committee questions how this will be incorporated into living donor informed consent policy and practice. The Committee indicated the following sentiments for the proposal: 3 Strongly Support, 8 Support, 0 Neutral/Abstain, 2 Oppose, 0 Strongly Oppose.

Region 8 | 09/22/2020

Region 8 vote: 4 strongly support, 9 support, 1 neutral/abstain, 6 oppose, 1 strongly oppose Comments: Multiple comments opposed the requirement for living donor programs to store specimens for 10 years due to concerns about consent, cost, ethical concerns, and logistics; a year was recommended by one member as an adequate timeframe for storage. One member commented that the guidance for pre-transplant testing is not very clear and that universal post-transplant testing seems like a poor use of resources with little clinical evidence justifying it. Several other comments were made in opposition to universal testing because it is logistically burdensome and costly (often not reimbursed) and not clinically indicated as disease transmission is a rare occurrence. Sample archival and testing when clinically indicated were suggested alternatives. There were several comments advocating to keep the hemodilution requirements. Members shared feedback opposing the transplant program’s requirement to document HBV vaccination status due to administrative burden and that this is often not part of the transplant program’s routine care; there was a recommendation that reporting HBV antibody status is adequate. One member commented that screening and diagnostic testing assays for candidates and donors may have different sensitivity and LOD that may not ultimately be comparable, so it would be helpful to comment or add guidelines on interpretations. A comment was received in support of removing the IR label as well as refining the risk criteria and removing the requirement for separate consent as these changes will likely increase access to these organs by removing unnecessary barriers.

Heart Transplantation Committee | 09/24/2020

The OPTN Heart Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for its effort in developing the Align OPTN Policy with U.S. Public Health Service Guideline, 2020 public comment proposal. The Committee supports the removal of the “increased-risk” donor designation but expresses concern about ensuring candidates are adequately educated about the risks associated with specific organs. The Committee also expresses concern about the time required to administer HBV vaccines, as many heart patients with acute conditions may not have the time to complete the full series of vaccinations over a 6 month span. The 96 hour deceased donor testing requirement also causes concern. If testing is not repeated every 48 hours, procurement may be hurried or delayed as a result of meeting the 96 hour limit and the potential 24 hours needed to receive new test results. This timeline may not align to the urgency of heart transplantation in some cases.

American Society of Transplantation | 09/24/2020

The American Society of Transplantation supports much of this proposal but does have some specific comments for consideration. Our comments and concerns are listed by the categories defined by the OPTN: • Risk assessment of living and deceased donors • The AST supports and fully endorses eliminating the stigmata of the “increased risk” designation from donors as well as modifications to the criteria for this designation, including the removal of hemodialysis and hemodilution. We caution that removing the terminology in a nebulous fashion without replacing it with a specific term will eliminate the benefit of a common terminology language. • The Society notes that there is a lack of a term to distinguish those situations where transmission is anticipated for HBV, HCV, or in HOPE-act-compliant cases, HIV from those in which there is an increased risk of acute HBV, HCV, or HIV, despite negative testing. • Transplant candidate informed consent • We agree with this policy change as special consent was the result of regulatory over-reaction to donor disease transmission which itself is extremely low. The 10 years of DTAC data shows that disease transmission is so low as to be unquantifiable in individual circumstances and should be balanced against the risk of ongoing chronic end-organ disease. • Centers should continue to have an open and honest conversation with organ candidates regarding the risks and benefits of accepting an organ from a particular donor. There is concern that the removal of the practice of specific informed consent for increased risk donor organs may undermine patient autonomy. Specific informed consent was a systematic approach to ensuring that important risk information was conveyed to patients. The proposed policy’s revision of relying on usual informed consent processes to cover the discussion of the unique risks posed by increased risk donor organs may fall short of facilitating a patient’s informed decision-making process in some cases. It is well documented that informed consent varies by transplant center and removing the specific informed consent may reduce the likelihood of discussions regarding risks and benefits of accepting increased risk donors occurring, and thereby reduce patient understanding. Removal of specific informed consent could also remove protections for the provider should a negative outcome occur. The AST would appreciate educational offerings on this topic for programs to provide clarity on best practices for informed consent of donors with these risk factors. • Recipient testing and reporting • For candidate evaluation, the requirement to assess the need to provide HBV vaccination. Add requirement to report vaccination status • The AST ID COP is a proponent of vaccination and feels strongly that patients should receive hepatitis B vaccination prior to transplantation. The AST understands the intent behind collecting these data and feel that HBsAb status should be collected. However, the collection of vaccination status may be beyond the purview of this policy. It is likely to add a burden to transplant centers and be logistically difficult. There is no central depository of vaccine administration and not even state registries are 100% reliable, particularly if vaccine is administered at pharmacies. The answer to if the patient received hepatitis B vaccination is difficult in that patients often receive different number of doses and types of vaccine, so it would be challenging to define the answer to the question. • Many thoracic recipients receive a partial vaccination series but are transplanted before it becomes effective. Moreover, in young recipients, there is more consistent vaccination status in recipients 40 years of age and younger. The requirement can be encouraged, depending on clinical status of recipient. • For kidneys, candidates often receive this vaccination at their dialysis center. The data collection related to HBV vaccination status will increase the burden on transplant centers due to the need to acquire vaccination status from dialysis units. Also, a majority of pre-dialysis CKD patients are not vaccinated, and it will be burdensome for transplant center to vaccinate them if asked to do so. A course of vaccination at 0,1 and 6 months may not provide immunity (Hepatitis B surface antibody [anti-HBs] > 10 mIU/ml) and many patients may require repeat courses of vaccination. It may not be feasible for patients to travel to transplant centers to receive vaccination. • For these reasons, we recommend keeping the assessment of HBVsAb level but not being required to verify HBV vaccination • Several community of practices gave feedback specifically on the subject of Universal Post-transplant NAT testing for HIV, HBV or HCV at 4-8 weeks post-transplant and HBV NAT for liver recipients at 11-13 months post-transplant as well as pre-transplant testing at the time of transplantation. • It was noted that universal testing of all recipients at 4-6 weeks after transplantation is a sizeable increase in testing, with associated financial burden for centers and patients particularly if some insurance does not cover it, as well as a logistical burden on laboratories. It will be important to understand whether recipients’ insurance will cover these additional tests, and if not, how expense related to this new mandate will be absorbed. • Previous post-transplant viral testing focused on patients receiving organs from donors with one or more risk factors. It would appear that most transmission events cited to support this change occurred following transplants from donors with risk factors or other viral diseases. For example, in a published analysis of HBV and HCV infections transmitted through organ transplantation investigated by CDC in the United States between 2014‐2017 (Am J Transplant. 2019;19:2570–2582), all 16 donors associated with HBV or HCV transmission events (7 and 20 respectively) met PHS increased risk criteria. Accordingly, the question is posed: have any transmission events been documented when using low risk donors who have tested negative for HIV, HBV and HCV following current guidelines? How many additional cases of transmitted viral diseases are expected to be captured by expanding testing to recipients of organs without risk factors (i.e. what is the number needed to test in order to identify one infection when using low risk donors)? Was there a cost-benefit analysis performed before adopting universal testing of recipients including those who do not have risk factors? Increased testing must be justified particularly due to reagent, analyte and staffing shortages engendered by the SARS-CoV-2 pandemic that have had broad implications and impacts on laboratories. • Moreover, not all centers may be able to perform this type of testing easily, and they may require exportation of their lab samples to another facility. We suggest having more permissive language to encourage testing to be within 3 months and requiring it within 6 months. We see no value for testing requirements after 6 months, as it is beyond any eclipse window at that point. • Consideration of risk benefit of these blood draws on small pediatric recipients has to be considered. The infectious disease labs may require a large blood volume at some centers, accordingly, requiring more testing may significantly add to anemia and lower blood volume. As Salvatierra et al showed back in 1998, there is a greater than two-fold increase in aortic blood flow after putting an adult kidney into an infant, and this increase was sustained for at least 4 months and appeared to be driven by the blood flow demand of the adult donor kidney. Furthermore, actual posttransplant renal artery blood flow was significantly less than normal renal donor artery flow. This is what led to aggressive intravascular volume maintenance to achieve and maintain optimum aortic blood flow, to prevent low-flow states that could induce acute tubular necrosis, vascular thrombosis, or primary nonfunction. Decreasing blood volume unnecessarily, particularly if a low risk group for these viruses could be detrimental in these VERY fragile small children. We suggest that children <20kg not have pre-transplant re-testing done if it was done in the past 12 months (unless they are at a higher risk) as the risk of these children getting HIV, Hep B or Hep C from eval to transplant is extremely low. • Finally, we suggest that a timeline for tracking universal post-transplant NAT testing be put into place to revisit its value for ALL recipients. The AST suggests considering 2- or 3-year period for universal testing and then an evaluation of the data and DTAC analyses to determine whether this practice should continue long term or be limited to specific populations, such as patients receiving organs from donors with at least one identified risk. • Collection and storage of donor and recipient specimens • The AST opposes the 10-year requirement of archiving donor samples. Archiving donor blood specimens for at least 10 years by living donor recovery centers will result in increased financial costs, logistical hurdles, and increasing material capacity for storing additional samples. We feel that storing living donor specimens for 10 years is unrelated to this policy. Transmission of HIV, HBV and HCV, if it occurs, will occur within the first few months of transplantation. Storing samples for 10 years will incur costs and logistical issues without the expectation of a benefit. • We offer the recommendation to the OPTN that living donor samples be stored no longer than two years post-transplant by recovery hospitals. The rationale for this is living donor related infections and malignancies are seen early on after transplantation unlike deceased donors and the incidence of donor derived infection and malignancy is significantly lower than with deceased donors so the degree of effort required from transplant centers to maintain specimens for 10 years will have very little yield. • Recent study found that viral infections presented a median of 48 days (range 11-776) after transplantation (Daniel R Kaul, Gabe Vece, Emily Blumberg et al. Ten years of donor-derived disease: A report of the disease transmission advisory committee. Am J Transplant 2020 Jul 5). The authors mention in the discussion section of their manuscript that risk of donor derived infection was 10-fold lower in recipients of living compared to deceased donors. • For 14.8.B The requirements for sample storage from living donor requirements are vague. Since most HLA labs already store reference samples on living donors, it is likely that they will take on the responsibility for this requirement. The sample storage will represent a marginal burden on HLA labs for living donors, but there is no recommendation for compensation to fund the storage space or the effort required for storage and documentation. In addition, there is insufficient guidance with regards to sample type and volume: the CDC guideline calls for “blood” and the OPTN guideline states “specimens appropriate for serological and NAT testing.”

Region 1 | 09/24/2020

Region 1 vote: 4 Strongly Support, 7 Support, 0 Neutral/Abstain, 1 Oppose, 0 Strongly Oppose Comments: Region 1 supports this proposal in general as a needed update to align with the USPH Guidelines but did comment on a number of specific concerns related to detailed requirements. A member stated the application of these new requirements could cause inefficiencies – if the need for re-testing is triggered because of the 96 hours pre transplant time frame, and a positive result is returned, it may require rerunning the match. The member also stated additional testing in such cases would not actually reduce risk of transmission if there is no requirement for the result to be returned prior to transplantation. The Speaker confirmed that the test results are not required prior to transplantation. The member then asked whether there was a rationale provided as to why all donors would be subject to the 96hr timeframe requirement versus only those identified as increased risk. The speaker stated that is an important consideration that will be taken back to the committee. A member commented this change is not only a reduction in risk, but also one of detection that can become positive if there is a delay in time of organ recovery from admission. A member asked if the relevant timeframe was from time between admission and recovery, why the requirement was set as a time period from testing to recovery. One member asked if there could be a way to centralize storage of pre-transplant living donor samples, possibly with a regional OPO. Several members commented on the 10-year living donor specimen storage requirement: • This change will be an additional expense for transplant hospitals. • There are differences between living donor and deceased donor specimen storage because of the availability of specimens post recovery. • One member suggested amending the 10-year storage sample requirement prior to board approval. They also asked for clarification on the type of specimen storage that would be required. • One member requested specific rationale for the 10-year requirement. Several comments pertained to testing and timing requirements section of the proposal, specifically the 96 hour deceased donor testing requirement: • Why is the 96-hour requirement for all donors, and not just increased risk donors? • A member asked if it is appropriate for the OPTN to require such specific testing timing. • The risk of transmission in a PHS increased risk donor that tests negative is extremely small and does not warrant the additional costs that could be incurred by re-testing triggered by the 96Ht requirement. • Should UNOS be requiring such specific postop viral testing at such specific time points or leave this decision to each transplant center? • Many OPOs draw serology and NAT testing early in the process on registered donors or in cases with early referrals which is a best practice. With the time of allocation, many of our cases would require a second set of labs which will be costly and do the labs need to be back prior to the recovery and transplantation of the organs? • Do the serologies within 96 hours have to be returned prior to going to the OR, and is that rule only if there is PHS increased risk behavior? There are concerns from an OPO standpoint on ensuring those results are back in the situation we need to rush a donor to the OR due to instability reasons or family time constraints. • The issue for OPOs is both operational and cost: if an OPO tests early in the process (for example-registered donor) which is a best practice, this could result in needing to perform a second test at a significant expense. Also OR times can be delayed unexpectedly which would again trigger an additional round of testing without any rationale of how that would further reduce risk.

Region 2 | 09/25/2020

Region 2 vote: 13 Strongly Support, 15 Support, 0 Neutral/Abstain, 5 Oppose, 0 Strongly Oppose Comments: • An attendee commends the Committee for the removal of the “increased risk” designation. This has always been a confusing thing for their patients to understand. While no donor is without risk, it will greatly reduce the anxiety of accepting an increased risk donor. • Several commenters opposed the need for living donor specimen storage for 10 years o An attendee noted that storing deceased donor samples makes sense due to the fact that multiple recipients can be affected. A living donor donates to one recipient so it would be easy to trace any discovered diseases. o Another attendee made the suggestion that living donor samples should only be stored if the donor consents to storage. Some living donors, particularly minority donors, may be apprehensive to store genetic material based on past discrimination or other experiences. Long term access to a living person’s genetic material can have many ramifications and may cause some donors to decline donation. o Another attendee noted the same concerns in regards to donor consent to the storage of their genetic material. The donor would have no control over what the material is used for and would be an invasion of the donor’s privacy. Which could result in a distrust in the living donation process. In addition, the evaluation of living donors is extensive and more reliable than with deceased donors, so the risk is more accurately assessed. The storage of the samples would also add an undue burden on transplant centers with no clear benefit. o Another attendee voiced opposition to living donor sample storage in that it is not relevant to Public Health Services guidelines. o Another attendee is opposed to any living donor sample storage greater than 1 year. o Another attendee commented that the living donor that the living donor specimen storage requirement should be shortened to 2 years. • A few comments were made in regards to the proposed 96 hour requirement between deceased donor serology testing and procurement: o One attendee noted that donor cases can be unpredictable and there are many factors that could delay procurement. They ask that the committee give more flexibility to the 96 hour rule because it will be difficult for OPOs to adhere to. o An attendee commented that the 96 hour time frame seems arbitrary. o Another attendee would like the committee to consider a scenario in which a procurement is delayed and the OPO has to re-run serologies. If there are conflicting results between the new testing and the original testing, would allocation have to start over, thus further delaying the process? • Member of the region also made several comments in regards to the proposed infectious disease testing of transplant patients: o An attendee voice opposition to the testing schedule for patients. It seems excessive to test all patients when it was mentioned that the transmission rate of the infections is very low. It should be up to the patient’s medical team to determine if additional infectious disease testing is necessary, given a patient’s risk factors. o Another attendee commented that the additional infectious disease testing may not be covered by insurance and would then be an additional financial burden on patients. The committee should consider that before making the increased testing mandatory. • Two attendees were opposed to the requirement for Hepatitis B vaccination status for all transplant patients. It would be very difficult for transplant centers to operationalize.