December 20, Dear Dr. Frieden:

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1 December 20, 2011 The Honorable Thomas Frieden, MD, MPH Director, Centers for Disease Control and Prevention 1600 Clifton Road, NE. Mailstop A-07 Atlanta, GA Ref: [Docket No. CDC ]; Public Health Service Guideline for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) through Solid Organ Transplantation; September 21, 2011 Dear Dr. Frieden: On behalf of the 83 U.S. member eye bank organizations, the Eye Bank Association of America (EBAA) appreciates the opportunity to comment on the U.S. Public Health Service s Draft Guideline for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) through Solid Organ Transplantation. Our remarks are offered in the spirit of collegiality and cooperation, with the shared intent of harmonization and reciprocity of standards, assurance of quality and safety, and accountability. We applaud your efforts to update and expand the 1994 Guidelines for Preventing Transmission of Human Immunodeficiency Virus (HIV) through Transplantation of Human Tissue and Organs. Although we understand that this guidance is intended for solid organ transplantation and not corneal transplantation, it will indeed affect the corneal transplant community. To that end, the eye banking and corneal transplant community need assurance that any guidelines or regulations are consistent, reasonable and evidence-based. This guidance, as proposed, would specifically affect eye banks which share organ/tissue donors with the organ procurement organizations (OPOs). EBAA Background The EBAA is the world s oldest transplantation Association, established in 1961 by the American Academy of Ophthalmology (AAO). The EBAA first established medical standards and an accreditation program for inspection of eye banking organizations in 1980, and certification of technicians followed in the late 1980 s. The Association s standards and procedures have been used as a model for adaptation by other organizations in the United States, and other countries. They are reviewed and revised twice a year by a board of renowned corneal surgeons and certified technicians with expertise and extensive Page 1 of 12

2 experience in eye banking and then formally considered by the American Academy of Ophthalmology (AAO), which has endorsed them each year since The EBAA standards represent best practices in eye banking, are based on science specific to ocular tissue, and enjoy widespread recognition and acceptance. The Medical Advisory Board is responsible for promulgating EBAA medical standards, and a U.S. Food and Drug Administration (FDA) representative sits on the board. The EBAA Accreditation Board, also established in 1980, conducts inspections of eye bank members on a regular three year cycle or more often, as necessary. This includes Canadian banks and others outside the borders of the U.S. Eye banks which are accredited by the EBAA follow EBAA medical standards, and employ EBAA procedures which closely parallel and often exceed those of the FDA Good Tissue Practice regulations. All eye bank members of the EBAA are not-for-profit organizations whose mission is to recover and provide donated human eye tissue for sight restoring transplantation procedures, education, and research. Significant gains in ophthalmology are, in large part, due to donated ocular tissue provided by these eye banks. The EBAA strives to ensure the superior quality of banked human eyes through the adoption and implementation of stringent medical standards. On behalf of our member banks, we would like to offer these comments for consideration. The EBAA looks forward to working with the Centers for Disease Control and Prevention, located within the Department of Health and Human Services and our other transplant partners to ensure the safety of solid organs, ocular and other tissues provided for transplant. General Comments: Although this is a guidance document, its likely impact and acceptance will be akin to a regulatory standard:...intended for use by OPO staff, transplant staff including physicians, nurses, administrators and clinical coordinators; and laboratory staff responsible for testing and storing donor and recipient specimens; and persons responsible for developing, implementing, and evaluating infection prevention and control programs for organ procurement organizations and transplant centers. As such, its recommendations should be based on the highest level of evidence and consensus. Category 1 recommendations have even more potentially burdensome implications: For policymakers: recommendations may be adopted as policy or is current federal and/or state statutes, regulation or standards. This document fails to provide a reasonable estimate regarding the overall rate of confirmed transmission of HIV, HCV, and HBV from donor to recipient. Similarly, there is no projection of the anticipated clinical benefit in terms of reducing disease transmission should these recommendations be implemented. This data should provide threshold information on which to base recommendations and their absence undermines the argument in favor of necessary regulation. Page 2 of 12

3 The draft document views the practice of solid organ transplantation from the sole perspective of minimizing the risk of disease transmission of HIV, HCV, and HBV. Because transplantation of organs from HBV and HCV infected donors is accepted medical practice in situations where the recipients are informed and accept the risks of potential transmission, we suggest that the focus of the guidance should instead be on reduction of unintended donor disease transmission. The USPHS should be commended for attempting to maximize the number of deceased and living donor organs made available for transplant by avoiding exclusionary criteria and instead identifying risk groups and recommended donor and recipient interventions. However the EBAA is troubled by CDC s statement in the Background Section under Donor Screening: Currently, potential blood and tissue donors who have risk factors for bloodborne pathogen infection, such as HIV, are excluded from donating, since the availability of blood and tissue exceeds supply. In contrast, organs may be considered life-saving and since demand far exceeds demand, increased risk donors are not excluded but can be accepted by transplant centers if patients are informed of the risks involved and consent. This comment implies that acceptance of blood and tissue by donors deemed to be at increased risk would be unacceptable. Despite the claim that the proposed guidelines are intended for solid organ transplantation only, the CDC is effectively making new exclusionary criteria for blood and tissue donors. The draft guideline completely ignores the impact on survival of those with irreversible organ failure resulting from a potential reduction in the number of solid organ donors due to the recommended screening strategies outlined. It is well known that the discard rate of donor organs categorized as elevated risk is higher than those that are standard risk. (See Kucirka, LM et. al., Curr Opin Organ Transplant 2011 Apr; 16(2): ) It is therefore highly likely that this guideline, if implemented, will result in a net decrease in the number of available deceased donor organs and an increased number of deaths of waitlisted patients. Whether this would be offset by any reduction in infectious disease transmission is not addressed by the data provided. The transplantation community has been working to standardize the interview process and develop a uniform donor history questionnaire (UDHQ) with the goal of minimizing the risk of donor-derived transmissions. The lack of harmonization between the FDA s Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue- Based Products (HCT/Ps) and the factors associated with increased risk of recent HIV. HCV, and HBV identified in this PHS guidance in Table 3 would hamper these efforts to develop a UDHQ with uniform applicability for organs and tissue donors. The implementation of a different set of criteria for assessing increased risk for organ and eye/tissue donors will create a confusing dichotomy for organ and tissue procurement organizations working with shared donors. These guidelines do not address how an organization should handle this situation and whether this information would need to be disclosed to the corneal surgeon or surgical facility. Page 3 of 12

4 EBAA is concerned that this draft document is not a consensus document, since virtually all members of the Expert Panel and Review Committee members felt compelled to withdraw their names from the document due to a lack of a collaborative process and serious objections with methodology and conclusions. The final Expert Panel consisted of only four specialists in laboratory sciences and epidemiology employed by the CDC and the final Review Committee included only one external physician member with experience in transplantation. Under these circumstances, it is extremely misleading to state that any of the recommendations are supported by expert consensus. The CDC needs to re-engage the experts in organ transplantation and seek input from all stakeholders before the publication of a final Guidelines document. These guidelines if published in their current form will have serious ramifications, decreasing not only the number of donor organs that may be accepted by recipients or transplant surgeons, but they will also affect the evaluation of ocular and tissue donors, further reducing the supply of these tissues. Donor Risk Assessment Many of the recommendations in this section refer to interviewing individuals regarding their behaviors or that of family members that would increase risk for acquiring HIV, HBV or HCV. We agree that a thorough donor history is important in establishing the presence of risk factors that may be associated with a poor transplant outcome. For interviews to be effective, a standardized, validated questionnaire is essential, along with adequate training of personnel for its administration. Establishing a validated questionnaire is a critical area for research in the future, to assess the efficacy in both high- and low-risk donor populations. It is our understanding that the goal of the risk assessment is to provide guidance regarding optimal donor testing and utilization. The Category IB recommendations in this section are based on literature that did not include potential solid organ donors and may cause the loss of potential donors based on questions that have a poor predictive screening value. There is limited data to clearly inform the level of risk associated with potential answers. Without this data, it may be challenging for clinicians to understand whether an answer represents a risk of disease transmission that outweighs the potential benefit of using the organs. Donor Risk Assessment, Recommendation #4. The recommendation that the father and mother of a pediatric donor be interviewed about behaviors that may have placed them at risk for acquiring infections that may have been transmitted to their child is intrusive and could exacerbate the distress to the family at the time of death of a child. Furthermore, this recommendation does not specify the intended age group. As a Category I recommendation, it is likely to be incorporated into policy to the detriment of scarce pediatric donors and their families. We would instead propose that you harmonize with the FDA s Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), and Page 4 of 12

5 require screening of the birth mother when an infant is one month of age or less. The interview with the father should only be required if the interview with the mother is not possible. Donor Risk Assessment, Recommendation #5. The recommendation that children with any risk factors associated with increased probability of HIV, HCV, and HBV be identified as increased-risk is vague and unnecessary. By referring to children, it is assumed the authors mean potential pediatric donors. The risk factors for potential maternal transmission are covered in recommendations 4 and 6. This recommendation should be reworded as it would seem to apply to all potential donors adult and pediatric. Donor Risk Assessment, Recommendation #6. We are in general agreement with this recommendation that children 2 years of age born to mothers with HIV, HBV, or HCV infection or who meet increased risk criteria should also be identified as increased risk. However, this has important implications for potentially reducing the availability of organs from an extremely small pediatric donor pool, increasing the already high mortality for children waiting for transplants. We are concerned that the reference age differs from the FDA criteria for child donors and fails to mention the risk associated with breast-feeding in the preceding 12 months. The EBAA requests that you harmonize with the FDA s Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) which includes children 18 months of age or younger and children if breast-fed within the preceding 12 months. Donor Risk Assessment, Recommendation #7. We are in agreement with this recommendation, since hemodilution may result in false negative serological and NAT testing. This is current UNOS policy. Guidelines regarding the use of organs from both average risk and increased risk donors with negative but unreliable screens should be outlined. If organs are used, a standardized approach to quoting/communicating risk to potential recipients should be defined. Donor Screening General Comments: The EBAA has concerns with the recommendation that the most sensitive test available should always be used. The most sensitive test may not be the appropriate test in the organ donor setting when weighing risk/benefit, cost effectiveness and logistics of implementation. In fact, the opposite conclusion was reached following a recent joint consensus conference of transplant infectious disease experts (see Humar et al., Am J Transplant Apr; 10(4): , which is notably absent from your references). NAT testing will almost always be more sensitive than antigen or antigen/antibody testing, but may be less effective in this setting due to specificity issues or delays in obtaining results that might impact organ quality or result in donor loss. The most sensitive test may result in an extremely marginal increase in yield (i.e. HIV, RNA and NAT versus fourth generation HIV or Ag/AB screening) particularly when used in average risk populations, but at an extremely large increase in cost. We question the advisability of preference for the most sensitive test without regard to the Page 5 of 12

6 cost effectiveness or availability. Costs will likely be even higher in the setting of organ donation where STAT testing of individual donors (rather than less expensive batch minipool testing) is performed. The term available needs clarification as to whether this is locally or nationally available; or perhaps this should be replaced with licensed by the FDA. Further research is needed to assess the validity of screening tests results for HIV, HBV, and HCV in relevant populations to determine the best available test for increased and average risk donors. Donor Screening Recommendation #1. We believe this recommendation for serologic screening to be appropriate for all living or deceased potential organ donors. Donor Screening Recommendation #2. We agree that all living donors should undergo serologic screening for HIV, HCV, and HBV and NAT screening for HIV and HCV. NAT testing significantly reduces the window period of undetected infection before antibodies develop. Screening potential donors many months prior to the date of transplant could allow donation to proceed from a donor infected subsequent to that screening. However, we are concerned the recommendation to screen all potential live donors within seven days of the intended date of surgery may not be feasible. A seven day time period may not be adequate to obtain the results of these tests in time to inform decisions regarding the operation, particularly if a given donor is part of a multi patient chain. In a study by Kucirka, et al., Am J Transplant. Mar 2009; 9(3): , 45% of OPOs who perform NAT testing send the specimens to a different state where 24/7 NAT screening is available. We are concerned with the statement Test results should be obtained before organ recovery occurs, if feasible. In a living donor situation, organ procurement should not proceed without knowledge of serologic and NAT screening results. In an elective procedure, NAT screening should be performed sufficiently in advance to guarantee these results will be available to inform decisions regarding the transplantation or early treatment interventions. Donor Screening Recommendations #3 & 4. The rationale for obtaining universal HIV and HCV NAT testing on all deceased donors is to reduce the window period until serologic testing becomes positive. However there are concerns that universal NAT testing of low-risk donors may lead to increased false positive results and the unnecessary exclusion of suitable donors. The question remains whether expanding the donor pool through enhanced acceptance of NAT negative organs would balance or exceed the organ loss from false positive NAT results. Studies of average-risk donors are needed to model the benefits over the risks (donor loss from false positive tests). Clear standardized guidelines should be developed for interpretation and response to initial and confirmatory test results. Will NAT testing be discontinued when alternative testing becomes available, or will these fourth generation antigen/antibody tests (when FDA-licensed and available) add significantly to the screening costs? We are puzzled by the statement: NAT results should be obtained either before, if timing allows, or after procurement. Is it the intent of the authors that organ transplantation may occur prior to obtaining the results of NAT testing? If so, how will performing NAT impact the transmission of HIV and HCV to recipients with results not available prior to implantation? Page 6 of 12

7 Donor Screening Recommendations #5 &6. We support the recommendation to perform HBV NAT testing on deceased donors identified as being at increased risk or when behavioral risk factors cannot be determined. Once again studies are needed to model the risk/benefit of HBV NAT testing of increased-risk organ donors. Experience in the blood system suggests donors with HBV infection are less likely to have risk factors identified by the social/behavior questionnaire compared to HCV and HIV positive donors. Current criteria to identify increased risk donors have not been validated for utility in identifying incident HBV disease in the current vaccine era. The implementation of NAT for HBV has only recently been recommended in the blood system. Currently available FDA-licensed donor screening platforms are moving to trivalent NAT testing in Therefore, HBV NAT testing may be done on both average and increased-risk donor populations, despite the poor quality of incidence data in even high-risk populations. HBV viral loads in window period donor are often extremely low, creating greater problems in differentiating true positive from false positive results. If NAT testing for HBV is implemented, we agree that having results available after recovery and transplantation might positively impact recipient care as preemptive treatment with antiviral therapy might prevent or modify infection and clinical disease. We would propose adding a recommendation to provide targeted HBV immunizations to patients with organ failure at the time they are placed on the waitlist, to further reduce the risk for transmission of HBV by an infected donor. Donor Screening Recommendations #7. This recommendation requires clarification: Does it mean that one can use FDA-licensed diagnostic tests as opposed to assays licensed for donor screening for living and deceased donors? This would be a change in national policy, would not harmonize with the donor testing requirements for HCT/Ps, and would represent an off-label use of the former tests. Donor Screening Recommendations #8. We do not believe that transplantation should proceed without serologic results. NAT testing results received after transplantation would clearly not protect the recipient, although early treatment for HIV and HBV could be initiated once results are obtained. We suggest this recommendation be reworded as follows: NAT results for HIV, HBV, or HCV may be reported following organ transplantation in situations of life threatening illness where benefits of transplantation outweigh potential risks of infection transmission. Donor Screening Recommendations #9: We agree that all donor screening should be performed as outlined by the manufacturer. Page 7 of 12

8 Table 3 Comments: Sexual Contact: The EBAA believes that the risk factor of persons who have had sex with > 2 partners in the preceding 12 months sets the multi-partner threshold too low, impacts the younger donors heavily, and would lead to a large proportion of the donor population being classified as being at increased risk. This would result in the requirement for special informed consent from a large proportion of recipients, and could reduce the number of organs considered acceptable by potential recipients. A widow or divorcee who has entered into another committed relationship within the year would be considered to be in a higher risk category by this criterion. It should be noted that the Donor History Questionnaire for donors of blood and blood components determines sexual risk factors based on unsafe sexual contact or sexual contact with at-risk partners, without asking the specific number of sexual partners. It is doubtful that a proxy historian will know the private and intimate lives of their loved one and be able to accurately respond to this question. The quality of data supporting this recommendation is poor. A review of the data tables that accompany the proposed guidelines indicates this risk was not identified for all three of the viruses, and further that the studies evaluated risk based sexual partners in a six month (rather than a 12 month) time period and was much more impressive for a larger number of sexual contacts (50 lifetime partners or at least 10 in the six month time period). Modeling should be done as to the impact that this is likely to have on organ donation and transplantation. In light of universal serology and HIV and HCV NAT testing of donors, and the move towards trivalent NAT test kits, this overly conservative threshold does little to protect the recipient population. The eye bank community is concerned that labeling donors who were not monogamous in the past 12 months as being at increased risk of transmitting HIV, hepatitis B and hepatitis C, would unnecessarily decrease the number of corneal donors. Although this guidance is not intended for eye and tissue banks, the divergent standard would create communication and interpretation issues with shared donors. Donors identified as increased-risk for organ donation might not be referred to partner agencies, and even if referred, the Donor Coordinator may errantly rule out the donor based on the documented increased risk categorization. Although persons who have had sex with 2 partners in the preceding 12 months is not exclusionary criteria for HCT/Ps, would we ethically need to communicate this to our corneal surgeons when offering tissue for transplant? The EBAA strongly recommends that you eliminate this risk criterion. We accept all of the other bullets under sexual contact, as these are consistent with the FDA s eligibility determination for HCT/Ps. We praise the CDC for narrowing the time frames for risk behaviors to the preceding 12 months, as this would be more associated with recent acquisition of disease. Maternal transmission: We agree with restricting this to infants < 2 years old and birth to a mother infected with HIV, HBV or HCV. Parenteral injection of drugs in last 12 months: We agree with this recommendation. Page 8 of 12

9 Intranasal use of illicit drug in last 12 months: We do not agree with this recommendation. There is low to very low quality evidence associating use of cocaine or street drugs and bloodborne pathogen infection. Many of these studies were confounded by injection drug use. In light of the recommendations for universal serology and HIV and HCV NAT testing of all donors, and the move towards trivalent NAT test kits, the inclusion of this risk factor does little to protect the recipient population. This would result in the requirement for special informed consent and the additional requirement for HBV NAT testing. Illicit drug use was not associated with HBV in a corneal donor study (Sanchez, et. al., Eye Contact Lens. 2006; 32(2): ). The Retrovirus Epidemiology Donor Study (REDS), funded by the National Heart, Lung, and Blood Institute (NHLBI) did not find intranasal cocaine use to be an independent risk factor for HCV. Therefore, this question was eliminated from the uniform blood donor questionnaire. The lack of standardization with HCT/P exclusionary criteria will confound donor screeners for shared organ and tissue donors. Inmate in a correctional facility: The time limit of > 3 days harmonizes with the HCT/P exclusionary criteria. We agree that for potential donors who are have been released from a correctional institution for more than 12 months prior to donation are not at increased risk for recent infection. STD treatment in the preceding 12 months: We agree with this recommendation. Hemodialysis in the preceding 12 months: There was low quality evidence which found an association between hemodialysis and HCV infection. Current CDC recommended practices include infection control procedures and monthly ALT testing and serologic testing for HCV every six months to monitor for the occurrence of new HCV infection among chronic hemodialysis patients. With the CDC recommendation for universal serology and HCV NAT testing of all living and deceased organ donors, the inclusion of this risk factor does little to protect the recipient population. A person on hemodialysis is not considered to be at increased risk for HCT/P or blood donation, so this risk criterion should be eliminated. Persons who have immigrated to the US in last 12 months from high or intermediate prevalence area (HBV only): We do not support this recommendation. By your own admission, this review found very low quality evidence to suggest a relationship between HBV and an individual s race, ethnicity, or national origin. The grade of evidence specifically for national origin/birthplace was also rated very low. In a general population study, acute HBV was not associated with birth in an area with a high endemic rate of HBV or having a household contact with someone who was born in an endemic area (Reference 116). More specific information is needed on geographic regions considered high incidence areas. Risk factors vary geographically and temporally and can change quickly in an outbreak setting. Coordinated vigilance would be necessary to modify this guidance in a timely manner when new information becomes available. Page 9 of 12

10 HBV-Infected Donors and Transplantation HCV-Infected Donors and Transplantation Eye banks do not transplant corneas from HBV- and HCV-infected donors and therefore we offer no specific comments to these recommendations. We are in agreement with the need for informed consent and risk reduction strategies. Recipient Informed Consent The EBAA is in agreement that counseling and informed consent should occur at the time of candidate listing and again at the time of organ offer, balancing the risk of donor-derived infection against the risk of remaining on the waiting list. We recommend the development of a standardized approach to the consenting process, with certain defined key elements to be included. We are not in support of requiring a separate informed consent for vessel conduits. This would be confusing to patients and it is often unknown whether or not an additional vessel will be required until the surgery is underway. The EBAA recommends this be incorporated into the informed consent discussion. Recipient Testing We suggest rewording Recommendation # 1 as follows: Baseline serologic testing for which recipients are previously negative should be repeated at the time of admission to undergo transplantation, but prior to implantation of the organ. We are in agreement with the post-transplant recipient testing recommendations, which follow a modified occupational exposure testing schedule. Donor and Recipient Specimen Collection and Storage Donor and Recipient Specimen Collection and Storage, Recommendation #1. OPOs may be unable to obtain both serum and EDTA plasma specimens, due to specimen volume or hemodilution, with potential regulatory consequences. Therefore this recommendation should be reworded to state that whenever possible, a separate EDTA tube should be obtained in addition to usual serum specimens, as an EDTA specimen is preferred for NAT. Donor and Recipient Specimen Collection and Storage, Recommendation #2. It is current OPTN/UNOS policy and AOPO best practice to archive deceased donor blood samples for 10 years, but there is no current mandate for storage of living donor samples. This will lead to increased costs, storage capacity issues, and infrastructure requirements. It is not feasible to require the separation of samples into aliquots, and this should be considered when storage capacity and specimen volume permits, as stated in Recommendation #3. Page 10 of 12

11 Donor and Recipient Specimen Collection and Storage, Recommendation #3. This recommendation restates the separation of EDTA plasma into multiple aliquots. This wording is much clearer and is more conditional in terms of stating when capacity exists and when there is adequate specimen volume. We recommend that you replace recommendation #2 with recommendation #3. Donor and Recipient Specimen Collection and Storage, Recommendation #4. The EBAA is in agreement that storage of archival serum or plasma specimens should be according to the test manufacturer s package insert (-20 C or colder). Donor and Recipient Specimen Collection and Storage, Recommendation #5. This recommendation creates an archival bank of living donors which would require the development of infrastructure and storage capacity by transplant centers. Ascertaining the infectious status of a living donor years after transplantation should be relatively easy and therefore a significantly shorter period of storage should be adequate. A living donor provides a directed donation to only one recipient, so this does little to enhance the safety of multiple organ and tissue recipients. Donor and Recipient Specimen Collection and Storage, Recommendation #6. The EBAA is in agreement that the FDA plasma dilution algorithm and calculation method should be utilized to determine if a specimen is acceptable for infectious disease testing. This is current OPO policy. Donor and Recipient Specimen Collection and Storage, Recommendation #7. The EBAA is in support of the recommendation to quarantine any stored blood vessels from a donor found to be HIV, HBV, or HCV infected, and either utilized only for research purposes or destroyed. Tracking and Reporting of HIV, HBV, and HCV Much of what is being recommended in this section has already been adopted by the transplant community and is part of current clinical practice and policy. The EBAA is supportive of these existing practices and appreciate the current document reflecting these practices. Tracking and Reporting of HIV, HBV, and HCV, Recommendation #1. The EBAA supports the requirement for the OPO to report to the transplant center if information becomes available that a deceased donor was infected with HIV, HCV, HBV, or any other potentially transmissible agent. This is consistent with current practice. Tracking and Reporting of HIV, HBV, and HCV, Recommendation #2. The EBAA supports the recommendation that information obtained by the transplant center that an organ transplant recipient has acquired a new infection with HIV, HBC or HCV that might be donor derived should be reported back to the OPTN. HIV, HBV, or HCV infection in a transplant recipient which occurs years after transplantation should be reported to the appropriate local and state health departments, but not to OPTN. Tracking and Reporting of HIV, HBV, and HCV, Recommendation #3. The EBAA supports the collection of nationally aggregated data on pre- and post-transplant bloodborne pathogen screening assessments but this recommendation does not specify who would be responsible for collecting and analyzing this data. Would this remain under the purview of DTAC? Page 11 of 12

12 Tracking and Reporting of HIV, HBV, and HCV, Recommendations #4 and #5. The EBAA is in agreement with the tracking and records requirement for organs and blood vessels. This is already OPTN policy. Tracking and Reporting of HIV, HBV, and HCV, Recommendation #6. The recommendation for reporting a recipient who is found to be newly infected with HIV, HBV, or HCV post-transplant is previously covered in recommendation #2, so this may be deleted. Tracking and Reporting of HIV, HBV, and HCV, Recommendations #7 - #12. The EBAA is in agreement with these reporting requirements. Conclusion The Eye Bank Association of America (EBAA) appreciates this opportunity to comment on the U.S. Public Health Service s Draft Guideline for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) through Solid Organ Transplantation. Our remarks are offered in the spirit of collegiality and cooperation, with the shared intent of harmonization and reciprocity of standards, assurance of quality and safety, and accountability. These guidelines, if finalized in their current form, are likely to have significant consequences for the transplant community and the costs of transplantation. For this reason we urge the PHS to revise this document with broad representation and meaningful input from the transplant community, the American Society of Transplant Surgeons (ASTS), the American Society of Transplantation (AST), the Association of Organ Procurement Organizations (AOPO), and NATCO, the Organization for Transplant Professionals. All stakeholders who can be affected should be part of the development process, including the American Association of Tissue Banks (AATB) and the Eye Bank Association of America (EBAA). We therefore recommend a delay in finalization of these guidelines until these issues can be properly addressed. Sincerely, Patricia Aiken O Neill, Esq. President and CEO Eye Bank Association of America Page 12 of 12