Pediatric Candidate Pre-Transplant HIV, HBV, and HCV Testing At a glance Current policy Currently, transplant patients must be tested for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) while in the hospital for their transplant surgery. This testing, along with other required tests, may result in too much blood being drawn from low-weight pediatric patients right before their transplant surgery and may lead to medical complications. Supporting media Presentation View presentation Proposed changes Allow hospitals to test patients aged 10 years and younger for HIV, HBV, and HCV before they are admitted to the hospital for transplant. Anticipated impact What it's expected to do Reduce the risk of medical complications that can happen when too much blood is drawn from a patient at one time. Allow hospitals to continue to safely monitor their pediatric patients for possible HIV, HBV, and HCV infections. What it won't do Change the HIV, HBV, and HCV testing requirements for patients over the age of 11. Terms to know Hepatitis B Virus (HBV): Formerly called serum hepatitis, it is caused by the hepatitis B virus (HBV). About 10 percent of cases progress to chronic hepatitis. It is spread through intravenous drug use, through sexual contact with infected individuals, through exposure to infected body fluids, and vertically from mother to child. Common symptoms include abdominal pain, fatigue, fever, jaundice, and elevated liver enzymes. A vaccine against HBV is available. Hepatitis C Virus (HCV): A form of hepatitis caused by the hepatitis C virus (HCV), previously known as non-A, non-B hepatitis. Most infections are due to injection drug use with contaminated needles. Blood transfusion-associated infections are rarer now than in the past due to improved blood donor screening. The CDC estimates 4.1 million (1.6 percent) Americans have been infected with HCV, of whom 3.2 million are chronically infected. Of the people who have chronic hepatitis C, 10 to 20 percent eventually develop cirrhosis and one to five percent develop hepatocellular carcinoma. Human Immunodeficiency Virus (HIV): The virus destroys cells in the immune system, which makes it difficult for the body to fight off infections; toxins, or poisons; and diseases. HIV causes AIDS, a late stage of the virus characterized by serious infections, malignancies and neurologic dysfunctions. Click here to search the OPTN glossary Comments Sophie Bso | 03/28/2022 Instead of doing it about age, add weight as well. Caitlin Peterson | 03/23/2022 I am supportive of the proposal with the following suggestions: Consider using age and weight to make this determination. A weight of <20kg should be considered. Transplant Administrators Committee | 03/23/2022 The Committee thanks the OPTN Ad Hoc Disease Transmission Advisory (DTAC) and Pediatric Transplantation Committees for their work on the proposal Pediatric Candidate Pre-Transplant HIV, HBV, and HCV Testing. The Committee supports this proposal for its safety considerations for pediatric candidates and the increased flexibility for programs. Region 6 | 03/23/2022 4 strongly support, 7 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose American Society of Transplantation | 03/22/2022 The American Society of Transplantation is supportive of the proposal and offers the following comments for consideration: We suggest using age and weight to make this determination. Consider <20kg and no recent exposures (blood transfusions, IV drugs, etc.). Additionally, the proposal should suggest a time frame prior to transplantation for this testing to be completed. We recommend documentation of results from a blood draw no older than 12 months. Potential policy language to incorporate these considerations is provided below: Candidate samples must be drawn during the hospital admission for transplant but prior to anastomosis of the first organ unless all the following are true 1) the candidate is less than 11 years old or weighs less than 20 kg 2) samples have been drawn within the past 12 months and 3) the candidate has not had a potential exposure to one of the above infectious diseases since samples were obtained. Attachment Region 2 | 03/22/2022 10 strongly support, 11 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose - This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member noted that the proposal uses age, but suggests it would be more appropriate to use weight. Additionally, another member encourages a continuation of focusing on pediatric candidates in order to ensure fairness, balance, and equity. Region 11 | 03/21/2022 Sentiment: 4 strongly support, 9 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: An attendee commented that the proposal should include a weight limit and any age should align with PE.LD and lung allocation systems NATCO | 03/21/2022 NATCO supports modifying the current policy for pediatric candidates pre-transplant HIV, HBV, and HCV testing. The proposed change will allow for candidates younger than 11 years of age to receive testing any time between wait listing and time of transplantation, allowing blood for testing purposes at the time of transplant or reducing the risk of medical complications with increased lab draws. We recommend specifying a time frame (repeat annually) as some pediatric candidates are highly sensitized and have prolonged wait times while waiting for an organ. American Society of Pediatric Nephrology | 03/21/2022 The American Society of Pediatric Nephrology appreciates the work of the Ad Hoc Disease Transmission Advisory and Pediatric Transplantation Committees in developing this request for feedback and the opportunity to support it. Frequent and high-volume blood draws are a risk factor for anemia in young children. This risk is higher in children with chronic kidney disease (ESKD) due to the associated chronic anemia. In March 2021, the United Network for Organ Sharing removed the ‘increased risk’ donor terminology and began requiring HIV, Hepatitis B, and Hepatitis C testing of all transplant candidates during the transplant hospitalization and prior to receiving an organ. This testing is currently required regardless of whether and when the patient had been previously tested for these viruses. The American Society of Pediatric Nephrology agrees with concerns that the March 2021 policy change could harm the smallest pediatric candidates with the smallest blood volume by requiring extra phlebotomy in sick anemic patients immediately prior to major surgery. This extra blood loss could result in increased need for transfusion, increased hemodynamic instability, and slower recovery from surgery. We support the proposed policy change to remove the testing time requirement for all candidates younger than 11 years. We applaud UNOS for its swift movement on this issue. National data shows a near-zero number of incident HIV, Hepatitis B, and Hepatitis C infections in the United States in children less than 11 years old; therefore, one episode of virus testing should be sufficient, regardless of its timing relative to transplant. While the risk of these infections in children aged 11 years and older remains low, the onset of ‘adolescent’ risk factors in this age groups makes the current age cutoff a reasonable balance between monitoring for transplant-derived infections and avoiding harm to a vulnerable patient population. Region 7 | 03/21/2022 Sentiment: 3 strongly support, 11 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member noted that they support the proposal as long as patient weight is taken into account. OPTN Pediatric Transplantation Committee | 03/20/2022 The Committee agrees with this proposal. They highlighted that the age-threshold and weight-threshold considerations were what the initial discussions of the DTAC-Pediatric Workgroup aimed to address. It was noted that the DTAC-Pediatric Workgroup settled on age 11 because of data from the Centers for Disease Control (CDC) that showed incidence of HIV, HBV, and HCV infections in children under the age of 11 near zero but also that considering an age of 12 as the threshold might align better with existing policies (e.g. liver switches from PELD to MELD score at age 12) Region 1 | 03/18/2022 Sentiment: 6 Strongly Support; 6 Support; 1 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. Comments: One attendee commented that this should also be considered for adults. Society of Pediatric Liver Transplantation (SPLIT) | 03/17/2022 The Society of Pediatric Liver Transplantation (SPLIT) supports this proposal allowing Hepatitis B, Hepatitis C, and HIV testing to be done prior to the patient’s admission for liver transplant. By increasing flexibility of timing for this testing, transplant providers and caregivers are able to better protect our most vulnerable patients. We would recommend amending the proposal to change the age cutoff to “under age 12” instead of under age 11. There is established shift from PELD to MELD score at age 12 already in pediatric liver transplant, such that children under age 12 are grouped together so a cutoff of age 12 would fit more naturally with the existing system. We do not think there is evidence supporting an increase in disease-transmission risk between age 10 and age 11 such that the cutoff needs to “under age 11” instead of “under age 12.” Pediatric liver transplant recipients under age 12 have greater likelihood of developing anemia as a result of their underlying diseases, which is exacerbated by iatrogenic blood loss. Further, the perceived benefit of repeat testing of patients in whom novel HBV, HCV, HIV infection risk is extremely low is outweighed by the ability to minimize blood draws; it may also decrease the risk of need for peri-operative blood transfusion. Improving the efficiency and decreasing laboratory studies in the transplant admission allows the patients we care for to progress to recovery as expediently as possible. Region 9 | 03/17/2022 Sentiment: 4 strongly support, 5 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: Several members commented they supported this proposal. American Society of Transplant Surgeons | 03/17/2022 The American Society of Transplant Surgeons (ASTS) supports the proposal as written. This proposal removes an unnecessary timeframe from policy while still ensuring pediatric candidates safety prior to transplant. Even with the removal of the time requirement, pediatric candidates who are 10 years old or younger will still have a baseline test result, since it is already common practice to perform the HIV, HBV, and HCV tests during the candidate evaluation process. Within this cohort of pediatric candidates, the risk of HIV, HBV, and HCV transmission is significantly low while the risk of adverse medical outcomes from overdrawing blood is high; thus, this proposal aims to limit infectious disease transmission while addressing patient safety concerns. Transplant Coordinators Committee | 03/16/2022 The Transplant Coordinators Committee thanks the Disease Transmission Advisory and Pediatric Committees for their work on the proposal Pediatric Candidate Pre-Transplant HIV, HBV, and HCV Testing, and provides the following comments. The Committee supports the proposal, as it increases the safety of pediatric transplant. However, the Committee inquires why the age of 11 was chosen, rather than age 12, which mimics the PELD score cutoff. In addition, consideration should be given to using weight as the metric, rather than age, as the proposal aims to prevent blood volume depletion in smaller candidates. Regarding the language of the policy, it was felt that a candidate’s age at waitlisting should instead be a candidate’s age a transplant, as there could theoretically be a period of years in between the two. Furthermore, based off of this suggestions, the Committee suggests that, in instances where there is significant time between a candidate’s waitlisting and their transplant, repeat testing should be considered. Finally, it was suggested that the policy may benefit from not stipulating a timeframe before transplant for testing to be performed at all, as risk likelihood was still exceedingly low within the specified age group. Anonymous | 03/11/2022 I strongly support this however I think it would be helpful to also include weight as a parameter. Also, I think the policy needs to be clear (if this is correct) that the HIV/HBV/HCV testing that was drawn during evaluation is sufficient and doesn't need to be repeated. When I heard this and read the information, it stated it had to be done between listing and transplant however all programs require this during evaluation and therefore it would need to be repeated if policy required it to be between listing and tx timeframe. Which I believe is not the intention. American Nephrology Nurses Association (ANNA) | 03/11/2022 ANNA supports with consideration of weight vs age and with set parameters on time frame for testing prior to transplantation. Attachment Region 3 | 03/02/2022 • Sentiment: 5 strongly support, 10 support, 2 neutral/abstain, 1 oppose, 0 strongly oppose • A commenter suggested instead of age, or in addition to age, weight should be taken into account as size of children can vary greatly. Anonymous | 03/01/2022 I fully support this policy, but feel it should be modified to body weight instead of age. Many causes of renal failure in the pediatric patient population are associated with syndromes that can affect growth and weight gain. Limitations on blood draw volumes are based off of body weight and not age. Justin Wilkerson | 02/25/2022 I support the initiative. Region 8 | 02/23/2022 4 strongly support, 11 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose - Region 8 supported this proposal. A member noted that testing should be done prior to the patient being hospitalized, for transplant, in order to minimize the negative impact of blood draws on young patients. Another member commented that he supports the consistent policy. Gonzalo Wallis | 02/22/2022 Strongly support the change in the policy and I suggest also to add weight restrictions agreeing with a previous comment that noted "ie <11 year or <25 kg". Anonymous | 02/22/2022 Strongly support this change, except I would also like to see weight restrictions applied to this change ie <11 year or <25 kg do not this these these tests at the time of admission. Region 4 | 02/18/2022 8 strongly support, 17 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose Anonymous | 02/17/2022 I support this proposal, but I do feel like instead of age cut off it should be by weight. There are many conditions that can affect a child's weight and the correlation between age and weight would then be nonexistent. Having a weight cutoff would ensure a more safe method of drawing blood on pediatric patients. Anonymous | 02/17/2022 I support this proposal because good points were made that if too much blood is drawn in a short time span, it can cause issues for the actual transplant. Though I think this idea should also be extended to people of a certain weight too because those who are underweight can face similar issues even if they are older than 10 years old. Anonymous | 02/16/2022 The proposal caught my attention in the way it is trying to reduce the risk that some medical procedures could cause in little kids. Changing this system is beneficial to young patients whose condition is not the same as a grown patient. Kids could develop loads of complications if they are treated as an adult. The policy is brief but shows notable information that helps us comprehend the situation. Region 5 | 02/16/2022 9 Strongly Support, 23 Support, 2 Neutral/Abstain, 1 Oppose, 0 Strongly Oppose - A member agreed with the comments that small children/babies (10kg and under) should be exempt due to concern over blood loss amount at transplant. A member institution commented that they are concerned that some children, 10-12 years old, who are failing to thrive and are underweight, may still have risk with the blood draw required. And these children are extremely unlikely to benefit from the re-testing given how rare acquisition is. It would help guard against this unintended consequence and be much more straightforward and consistent with other liver transplant policies (i.e. switch from PELD to MELD) to change the age from "less than 11" to "less than 12". A member supported the policy and provided feedback by commenting that either age less than 12 years old or a weight less than “x”kg should be used since some older kids have growth challenges and will be small with low blood volumes. Region 10 | 02/16/2022 4 Strongly Support, 10 Support, 2 Neutral/Abstain, 1 Oppose, 0 Strongly Oppose. This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member mentioned that the volume of blood being proposed is still a lot for very small children. Another member suggested that in addition to the age requirements, the proposal should also include a weight limit. Their suggestion would be to not require testing for patients less than 25kg or 30kg. It was also suggested that the proposal should specify within what time frame before transplant the testing should be completed. Anonymous | 02/12/2022 I support this proposal, with strong preference to base the cutoff on < 30 kg weight. Anonymous | 02/09/2022 I support this proposal and the suggestion that a weight based cut off be used, rather than age. Hans Gritsch | 02/03/2022 I support the proposed changes. Jon Garrison | 02/01/2022 I have worked with pediatric transplant for 5 years. Patient safety is a huge component of my job. That's not different from other health care professionals, but what does set me apart is reminding those in my adult hospital that children can't always follow the guidelines of adult transplant. We often have to space out all the required bloodwork for pre and post transplant. Some of our patients are 10kg, and will require 20 tubes of blood "at one time". This is unsafe. And as long as there are no sensitizing events, the blood draws should be able to be spaced out. There is no benefit to getting them all on admission, at one time. We risk making our patients anemic just before surgery, making it all the more likely they will require a blood transfusion, which can sensitize the patient and make transplant more difficult, or likely to fail. Anonymous | 01/27/2022 As a pediatric transplant surgeon, I support this proposal with some reservations regarding the age cut-off for this requirement. There are clearly children born with syndromic disease processes who are quite small in terms of body weight despite their age. Sine the appropriate concern of the Committee is the effects on small children due to large volumes of blood being drawn prior to transplant - it might be more beneficial to ensure that children < 30 kgs at the time of transplant are exempt from this requirement due to the excessive volumes of blood that will need to be drawn. The principle of this policy is excellent.