Comments

Region 1 | 08/29/2024

Sentiment: 1 strongly support, 5 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

Overall, the region supports the proposal. One attendee advised against the committee basing the fungal blood culture policies on older technologies when new ones exist. An attendee asked if the committee had considered different ABG settings when a donor is DCD versus DBD, as it is harder to change ventilator settings for DCD donors. A member requested the committee consider the testing requirements when EVLP is used because some of the tests might not be able to be done in an EVLP scenario. Another attendee commented that with donor hospital staffing issues, testing results could quite often fall outside the 4 hour timeframe. They continued to say they worry about how closely this would be audited as it's less a measure of OPO willingness to have timely results, and more a reflection of donor hospital staffing issues. A comment was made supporting the proposal but requesting that some flexibility be incorporated into the policy to account for issues, as mentioned above, that are out of the OPOs control. They expressed this should be a balance between providing needed information and not inhibiting OPOs from allocating lungs when required testing is not available. Lastly, they suggested adding a requirement in policy that programs review all donor information before requesting additional testing. Additionally, an attendee asked that there be a requirement that another member wondered if there would be any consequences if the testing requirements weren’t met and recommended the committee consider adding some enforcement language. An attendee questioned whether this proposal has the potential to disproportionately disadvantage smaller hospitals who may not have the resources to complete this testing. 

OPTN Heart Transplantation Committee | 08/27/2024

The OPTN Heart Transplantation Committee thanks the OPTN Lung Transplantation Committee for requesting feedback about the Promote Efficiency of Lung Donor Testing proposal during the Committee’s August 7, 2024 meeting. The Committee members concurred that the proposed changes are appropriate and thanked the Lung Committee for undertaking the project. Committee members agreed that the proposal strikes the appropriate balance in meeting the needs of the recipient lung transplant programs and the resource capacity of the donor OPOs. The Committee said that clear testing expectations will be helpful, reduce confusion, and potentially improve efficiency during the allocation process. It was also agreed that the more structured and/or frequent testing is not excessively burdensome, and will help identify changes in donor quality quickly. Some members felt that the changes help policy come into alignment with the current standards of care. It was appreciated that the policy provides flexibility regarding how pulmonary artery pressure is estimated, by echocardiogram or right heart catheterization, because not all programs can perform right heart catheterization.

Region 8 | 08/27/2024

Sentiment: 5 strongly support, 9 support, 3 neutral/abstain, 3 oppose, 0 strongly oppose

The region supported the proposal with the following requests for clarity and language changes. Several members suggested the x-ray should be within three hours, and there needs to be clarification on the “initial offer”. They suggested changing the policy language to “upon starting allocation”. They explained a program may mistakenly expect an x-ray within three hours because it’s their first time seeing the offer. Regarding the echo – rural areas may not be able to get an echo if the OPO is not pursuing heart donation. Smaller hospitals may not have the ability and the OPO must decide where to push to keep allocation moving.

· A member pointed out that the proposal needs to consider the impact of the donor hospital limitations in the wording of the requirements. Even though the OPTN states these must be required the OPO can't force a hospital to complete them especially with a DCD donor or if there are limited resources. There should be language in the proposal that provides leeway for the OPO that cannot complete the testing.

· Several members recommended changing language to clarify the timing of ABGs/CXR on primary offer time. They proposed the language should be, within three hours of lung allocation and every 24 hours after, or with patient status change. They also recommended consideration of donor type in the language and to remove the requirement of echo or right heart catheterization, since that is not possible at every hospital.

· In response to the question on whether the proposed guidance for fungal and bacterial cultures, chest CT scans, chest x-rays, and RHCs are appropriate recommendations – attendees confirmed they are appropriate, overall. But an attendee emphasized that, when providing CXR images, photos of a CXR on a computer monitor should be avoided. 

· The pediatric community had concerns about 0-11 candidates not having the same increase in access, and suggested the committee consider giving points if the donor is pediatric. They also suggested requiring X-ray images and interpretation. Regarding the imaging language, when providing a chest x-ray and chest CT scan results, there should be a preference for images in DICOM readable format as opposed to photographs or videos of computer display screens (which could be added to any guidance document).

· In response to the question on whether community members support the use of the NHLBI ARDS Network formula for IBW or prefer to use a different formula when calculating IBW – an attendee said the NHLBI ARDS Network formula is as follows: Male: PBW (kg) = 50 + 2.3 (height (in) – 60), Female: PBW (kg) = 45.5 + 2.3 (height (in) – 60). And commented that these formulas are validated for adults. And that the OPTN should determine the most appropriate IBW calculation for children.

· An attendee requested clarification on the range for PEEP for O2 challenge prior to initial offer. They appreciated the option for CXR to be image or interpretation prior to initial offer, since this allows the OPO to meet the time requirements. And allows the OPO to be able to continue to provide the information available to meet timing requirements without delaying the process.

· A member pointed out that it’s important to remember that OPOs are guests in donor hospitals. Particularly in the case of DCD donors, where OPOs must work with the patient's doctor and may not be able to order tests as frequently as this guidance suggests. Further, right-heart catheterization, or even echocardiograms may not be available on demand.

· Another said that more data is great as long it doesn't create additional burden on timing of offers by OPOs to transplant centers. Notably, several donor hospitals in Region 8 are rural and have limited or no ability to provide cardiac catheters, etc. (especially on demand and 24 hours). 

OPTN Organ Procurement Organization Committee | 08/22/2024

Right Heart Catheterization (Cath):

·      There's confusion about whether it's a requirement for all lung donors.

·      Clarifications were made that it should be considered if needed, not necessarily for all cases.

·      It's mentioned in a guidance document but needs to be double-checked.

Echocardiogram (Echo):

·      Members suggested a standard procedure for multi-organ donors.

·      Should be performed and provided at the time of organ offer.

·      Either an echo or a right heart cath is needed from a lung transplant perspective.

Availability and Timing Issues:

·      Concerns raised about obtaining these tests in smaller hospitals or time-sensitive situations.

·      A member suggests many patients would have had an echo as part of initial work-up, but not always. A right heart cath would not normally be something completed.

·      A member worries about potential delays in cases like young, healthy lung donors with short timeframes.

·      DCD (Donation after Circulatory Death) vs. Brain Dead Donors:

·      Question raised about control over measures in these different scenarios.

Standardization:

·      Discussion about standardizing how frequently blood gases are done and under what settings.

·      It was emphasized that standardization is more important than specific numbers.

·      Provide some clarification that the O2 challenge is completed within 3hours of the beginning of lung allocation and then every 24 hours unless something with the donor changes

·      Recommendation to include an "escape clause" in the policy for situations where tests can't be obtained.

·      A member suggests wording the policy to require an echo but acknowledge circumstances where it's not attainable.

Regional Differences:

·      Acknowledgment that some regions may have difficulties obtaining these tests consistently, especially in smaller facilities

Region 4 | 08/19/2024

Sentiment:  4 strongly support, 11 support, 2 neutral/abstain, 2 oppose, 0 strongly oppose 

During the discussion several attendees raised concerns about the ability of OPOs (Organ Procurement Organizations) to meet the requirements, as they often rely on donor hospitals that may not have the necessary capabilities. While providing thorough results, images, and standardized tests was deemed reasonable, the timing demands were considered an undue burden. Attendees suggested that HRSA or CMS should require donor hospitals to complete evaluations within 3 hours and provide a physician to write orders for DCD (donation after circulatory death) donors. 

There was also a recommendation that catheterization requests should take into account factors such as drug use, age, and medical history. Another attendee emphasized the need for echo images to be accessible, as smaller hospitals might struggle with interpreting conditions like pulmonary hypertension or right ventricular involvement. Reviewing these images could help mitigate such challenges. 

Additionally, attendees commented that the requirements for echo and right heart catheterization (RHC) should not apply to all patients, as access to these procedures could cause delays, making it inefficient to perform RHC on every patient. There was also a call for a better balance of representation between transplant and OPO members within the committee, as the current ratio (2 out of 20 members representing OPOs) may not adequately reflect OPO perspectives. 

Region 2 | 08/16/2024

Sentiment: 9 strongly support, 11 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose 

Members of the region were supportive of the proposal.  There was strong support for the proposed changes to transplant practices, with several suggestions to further enhance the process. One attendee suggested including peak and plateau pressure measurements alongside arterial blood gases (ABGs) in the OPTN Computer System, as many centers frequently request this data when receiving organ offers. Blood gas data is seen as a valuable addition, though there was debate about whether certain requirements, like making X-ray images available, should be mandatory rather than just guidelines, considering the operational capacities of OPOs.  Another attendee noted concern that chest X-rays may not always reveal underlying lung pathologies, which can be detected by CT scans. It was suggested that chest CT scans should be required in certain cases. The burden on transplant centers and patients, including the stress of extensive traveling and testing, should be minimized as much as possible.  Standardization across the transplant process was emphasized as crucial for success. There was agreement on the importance of adding peak and plateau pressure information from mechanical ventilation. However, concerns were raised about the practicality of requiring fungal culture results, which can take over 28 days to obtain; one attendee suggested that only preliminary results should be required.  Overall, the attendees highlighted the importance of requiring documentation, particularly for chest CT scans to catch issues that X-rays might miss. Additionally, the discussion underscored the need for balancing thoroughness in the organ evaluation process with the practical limitations faced by OPOs and the stress placed on donor families and patients. 

Neeraj Sinha | 08/05/2024

I support all the proposals and believe they will improve efficiency. I would also suggest the following:
1) Add peak and plateau pressure measurements coinciding with ABGs.
2) Change "updated chest x-ray interpretation or images at least every 24 hours between the time of the initial offer and organ recovery" to "updated chest x-ray interpretation or images at least every 12 hours between the time of the initial offer and organ recovery"
3) Expand "fungal and bacterial culture results" to "fungal and bacterial culture results reviewed from donor hospital EMR within 1 hour prior to the initial offer and updated on DonorNet, and then reviewed and updated on DonorNet at least every 12 hours between the time of the initial offer and organ recovery"
4) Names of antibiotics at the time of offer, if on any antibiotics
5) Enter ideal body weight and predicted TLC of donor in the DonorNet, in the space immediately above the ABG/ventilator data fields. They are calculated from height, age and gender, and availability of the computer-generated numbers will sidestep the transplant team's need to manually verify those numbers.

Luke Preczewski | 08/02/2024

I support this proposal; however based on discussion with our involved professionals, recommend the following changes:

1. Add the peak inspiratory pressure (PIP) to the viewable vent settings in the “ABG/Vent Settings” Section
2. Add patient position (whether supine or prone) to the “ABG/Vent Settings” Section
3. Including intake as a mandatory field in the intake and output flowsheet in the “Vital Signs Donor Management Indicators” Section
4. All recommendations should be applied for DCD donors as well

Jeff Lucas | 07/31/2024

How much direct feedback from Donor Hospitals, not that filtered through the OPOs, was obtained to ensure that additional requirements would not be a barrier to lungs being utilized?

Would potential recipients have transparency regarding the "if obtained" qualifier; i.e. - "the lungs you are being offered have not been evaluated via CT scan as the donor hospital does not have that capability?"