Comments

Region 5 | 09/25/2024

Sentiment: 3 strongly support, 10 support, 12 neutral/abstain, 0 oppose, 0 strongly oppose

Region 5 supports this proposal but suggests obtaining more OPO perspective feedback, evaluation, and input on operational feasibility. Specifically, an attendee commented that it would be helpful to assess the additional work this might impose on the OPO and the timing consequences. A member commented that “recruitment maneuver” is too broad and needs a more specific definition. Another member explained they rely on the hospital availability for draws, so timing may be out of the OPO’s control. They also agreed with adding "if performed" for echocardiograms or catheterizations. Regarding the more frequently challenging cases, a member commented there’s a concern for donor stability (hemodynamic stability). An organization said that the lung donor testing must be more consistent and protocolized. They explained OPOs tend to operate under their own protocols such as only getting at CT chest if requested or obtaining ABGs every 8 hours versus every 6 hours, etc.

UC San Diego Health Center for Transplantation | 09/24/2024

The UC San Diego Health Center for Transplantation appreciates the time and effort put forth by the OPTN Lung Transplantation Committee and their collaboration with the OPTN OPO Committee in drafting the proposed modifications to Promote Efficiency of Lung Donor Testing as well as the opportunity to provide feedback. The Center generally supports proposals aimed at improving operational efficiency and we recognize the importance of such modifications as allocation policies and practices continue to evolve.

We certainly appreciate the OPO community’s efforts to streamline the organ offer process by sending information out to centers as early as possible in the allocation process. We also recognize the potential concerns OPOs may have regarding the ability to meet the requirements within the timeframes proposed here, given their reliance on donor hospitals that may not have the necessary capabilities and/or may be struggling with resource and capacity issues as well as the variability of hospital policies on the management of DCD donors (i.e. resistance to perform some of the testing prior to death).

We do however, also recognize the importance for standardization to the extent possible, across the donation and transplant process. In order to quickly and efficiently review and make a determination on the suitability and appropriateness of an organ being offered for transplant, programs must have access to necessary information in a timely manner. While we believe the modifications proposed here seem to strike an appropriate balance through policy and guidance, we would support a rapid process improvement pilot that would allow OPOs to establish necessary protocols and gather operational data on the frequency and reasons why the requirements could not be met for the Committee’s consideration prior to formal adoption of policy standards which may lead to unavoidable non-compliance. Alternatively, the policy could be modified to qualify “when said testing is available,” although we would caution against using non-enforceable language in policy.

HonorBridge | 09/24/2024

The impact of the proposed testing requirements without modifications could have significant impact to OPOs. Some of the testing requirements may not be possible for DCD donors and donors at small hospitals with limited resources. The language in the proposal does not allow for flexibility when circumstances prevent OPOs from obtaining the required testing. We recommend adjusting the language to provide for situations when the testing is not able to be completed.

Gift of Life Michigan | 09/24/2024

We appreciate the Committee’s work and the opportunity to comment.

We generally support inclusion of all information that will be helpful to those making decisions about transplant compatibility of organs. We also generally agree that the testing proposed by the Committee would be helpful.

We fall short of full support because there is widespread variability in the availability of some of the proposed testing depending upon the donor hospital. Even more variability or possibility exists in the case of a potential DCD donor because of concerns or resistance to perform some of the testing prior to death.
We support the concept but hope the committee can refine the requirements or to insert a qualifier such as “when available” to account for variation around the nation.

Legacy of Hope | 09/24/2024

Thank you for the opportunity to comment on this proposal. Legacy of Hope is supportive of the intent of the proposal. However, as written, the proposal needs some adjustments to account for the potential strain this could put on OPOs and Donor Hospitals.

The proposed update to chest x-ray requirements is specifically beneficial this OPO as it is easier for our OPO staff to obtain CXR images than the radiologist read. Often, waiting on this interpretation delays the start of lung allocation. With required organ shares, the delay in starting lung allocation delays all other organ allocation.

While we do support guidance on frequency of ABGs during allocation, the 4-hour requirement could be difficult due to other donor testing and hospital staff availability. We urge the committee to update the policy to provide some flexibility in the requirements.

We do have concerns that the addition of new requirements of RHC and/or Echo prior to organ offers could decrease allocation efficiency. Donor hospital capacity to perform the imaging and provide a read timely can vary greatly. In cases where we have family time constraints, OPOs would have to forego lung allocation entirely, or operate outside of OPTN policy and allocate without required testing.
For DCD donors, we do not routinely perform cardiac catheterization. We believe that for DCD donors, heart catheterization specifically should be shared “if performed” and not required.
We feel there should be some exceptions to the requirement if the testing could delay allocation. We encourage the committee to consider applying offer filters for centers who require Echo/RHC results prior to the offer if this testing is unable to be performed.

Additionally, we feel it would be beneficial to provide a link to the “Guidance on Requested Deceased Donor Information” within OPTN policy to streamline review of required and proposed items.
While this proposed policy change provides transplant centers with all the data they could need to decide on an offer, it adds an extra burden on OPOs and Donor Hospitals. We feel it could be a successful policy update with some adjustments to address the concerns listed above.

UW Organ and Tissue Donation | 09/24/2024

UW Organ and Tissue Donation appreciates the opportunity to submit comments regarding the proposal to promote efficiency in lung donor testing.

We have concerns about the requirement of performing echocardiograms and/or right heart catheterizations. For example, the capacity of some donor hospitals (especially smaller hospitals) may not be able to perform these timely or complete a read. Mandating these tests before OPOs can make offers may lead to delays in allocation, increase costs, and undermine the Committee’s goals for improving allocation efficiency. It is common for transplant centers to decline lung offers for reasons unrelated to these tests. Therefore, requiring OPOs to obtain them beforehand may hinder timely assessments without adding value. In addition, lung centers may accept without these tests even being performed. UW Organ and Tissue Donation will always collaborate and attempt to perform any non-required testing that a lung center requests and evaluate on a case-by-case basis considering donor timing, donor hospital abilities, etc. We recommend adding "if performed" to the policy so that it is not a requirement but a recommendation.

Additionally, we are concerned about the implications of this additional testing for DCD donors. OPOs rely on hospital staff for the ongoing medical management of these donors, including necessary diagnostic tests. The availability and willingness of hospital staff can vary significantly, potentially impacting the timely completion of required tests. Moreover, donor families face time constraints that must be respected, and this requires additional consent from families if we were to perform a heart catheterization for lung evaluation. While we support guidance on required tests and their timing, we urge the Committee to consider flexibility for OPOs.

Thank you for considering our perspective on this important issue.

Region 3 | 09/24/2024

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

During the discussion, some of the OPO representatives in attendance commented that the proposed policy changes need careful evaluation, as they place unnecessary burdens on Organ Procurement Organizations (OPOs) and donor hospitals, particularly smaller hospitals. They added that this proposal has the potential to reduce organ recovery in ideal and young donors. Some attendees commented that the requirement for fungal cultures should be removed because all lung recipients are already on antifungal treatment, and following these cultures creates undue delays, especially when the donor may not even be a lung donor. Several attendees raised concerns that while some of the requirements are currently in guidance, often guidance is interpreted as required when in the middle of allocation. There was also feedback that flexibility in policy is needed to accommodate hospitals that may be uncomfortable performing certain procedures on DCD (donation after circulatory death) patients. One attendee commented that an ECHO should remain in the guidance document. There were also comments that the policy should focus on clear requirements rather than optional testing. One attendee commented that these policies are requiring things of donor hospitals rather than OPOs and OPOs don’t have the authority to make donor hospitals comply with the requirements. They added that the proposal creates greater inefficiency on the donor side because the additional requirements will add more time to the allocation process. Another attendee added that changes in allocation can also lead to increased costs for the transplant programs due to travel time and cold ischemic time. One attendee commented that another solution to promote efficiency in lung allocation would be to review the impact of offer filters and consider making some filters mandatory. 

OPTN Operations and Safety Committee | 09/24/2024

The Operations and Safety Committee thanks the OPTN Lung Transplantation Committee for their efforts on this proposal and the opportunity to comment. The Committee expressed opposition to the proposal as written, with concern as to whether the proposed requirements are feasible for OPOs in all cases. Specifically, the Committee noted that these requirements may be most difficult to meet in small hospitals with limited resources and for DCD donors. One member explained that it can be difficult to obtain testing at smaller hospitals, especially if the testing must be performed at regular intervals overnight. Members noted that the proposed timeframes may prevent OPOs from performing recruitment maneuvers, such as proning. One member noted that these timeframes also mean any recruitment maneuvers performed would need to be reversed before the benefit of the maneuvers are achieved. The Committee recommended increasing flexibility within these requirements, such as relaxing the time frames or considering certain items as recommended as opposed to required. One member offered that a larger range, as opposed to a specific time frame, can reduce the impact of delays to allocation. 

Versiti Wisconsin | 09/24/2024

Versiti Wisconsin appreciates the opportunity to submit comments for the Committee’s consideration regarding the proposal to Promote Efficiency of Lung Donor Testing.
Versiti has concerns mainly related to donor hospital capacity, both large and small hospitals, to perform additional stat testing such as echocardiograms and right heart catheterizations. Requiring OPOs to obtain an echocardiogram or right heart catheterization prior to making offers will delay allocation, increase expense, and undermine the Committee’s larger efforts to increase allocation efficiency. It is common for OPOs to see transplant center decline lung offers unrelated to an echocardiogram or right heart catheterizations and requiring an OPO to obtain this testing prior to initiating offers will result cause delays without necessarily adding value to transplant center’s initial assessment of an offer.
We also have concerns related to this additional testing on DCD donors. OPOs rely on care providers to continue to medically manage DCD donors. OPOs do not control ventilator management and rely on the hospital staff to complete diagnostic tests at the time frame required by OPTN policy. Physician practices and hospital staffing availability varies by hospital, and some hospitals may not be willing or able to dedicate the necessary time and resources towards performing these tests within the specified time frames. Donor families also have time constraints which require special consideration. While we support guidance on the required tests and testing timeframes, we encourage the Committee to consider some flexibility for OPOs when donor hospital resources prevent the OPO from meeting the requirements.

NATCO | 09/23/2024

Promote Efficiency of Lung Donor Testing

Lung transplant programs report since the implementation of continuous distribution of lungs, they are receiving more offers than before and many of those offers they would consider “incomplete.” The Lung Transplantation Committee has proposed changes to the required donor testing for lung donors that would affect OPOs and donor hospitals.

NATCO represents transplant professionals that work in both lungs transplant programs and OPOs. Our response is a consideration of both perspectives to balance both an increase in efficiency and lung utilization.

Arterial Blood Gases:

• The committee has indicated the PEEP range, FiO2 and TV preferred for challenge gases but has not indicated which vent mode these challenge gases should be drawn on, for clarity and consistency a vent mode should be indicated and a specific PEEP rather than a range. The committee should also standardize the formula used to calculate IBW for adults and children.

• The committee has requested ABGs be drawn every 4 hours between the initial offer and the organ acceptance. While this is the standard and the goal on most donors, this exact timing may not always be feasible for multiple reasons. Allowing leeway such as every 4-6 hours would be more realistic.

• The committee is requesting challenge gases not be drawn within 30 minutes of any recruitment maneuver. This is a vague statement that is open to interpretation since OPOs have different ways of defining and performing lung recruitment. A more specific definition of recruitment maneuver that would adversely affect the challenge results is recommended.

Chest CT:

• A chest CT within 72 hours of the initial offer is ideal for all lung donors. In the event of expedited lung offers, a repeat chest CT should not be required. In these types of cases, it should be considered if a chest CT is a mandatory allocation requirement at all. Additional required testing should not create an outcome of making it more difficult to place lungs for transplant.

CXR:

• The timings are attainable and realistic for and OPO to obtain for each donor. CXR more frequently than every 24 hours for lungs being allocated for transplanted would be recommended.

Echo and/or Right Heart Cath:

• While both diagnostics will allow a transplant center to make more informed decisions, there should be considerations for expedited cases, invasive procedures in the potential DCD, and donor hospitals without the capability of a cardiac catheterization. Again, creating additional mandatory donor testing should not cause it to be harder to place lungs for transplant.

Pieces of information that could be required for lung allocation that would not cause an increased burden on the OPO or donor hospital would include lung measurements, PiPs and plateau pressures, and reporting of antibiotic coverage and of any proning.

The proposal states the objective is to make it easier for transplant programs to say “yes” to organ offers, however it can’t become impossible for an OPO to get the required testing to allocate an organ. NATCO believes there is not enough of a balance in this proposal and it will create a heavy burden on the OPO, donor hospital, and ultimately the donor family. NATCO believes the proposal as written will have an unintended consequence to decrease the number of lungs allocated and placed for transplant.

Mid-America Transplant | 09/23/2024

Mid-America Transplant (MT) appreciates the opportunity to provide feedback to the OPTN regarding its proposal to Promote Efficiency of Lung Donor Testing.

MT generally supports the Committee’s proposed changes to lung donor testing in OPTN Policy 2.11.D (Policy); however, MT would like to know if the Committee had any concerns of oxygen toxicity to the donor lung with the frequent ABGs on an FiO2 100%. OPOs routinely increase the FiO2 to 100% for 30 minutes prior to drawing the ABG. Theoretically, the OPO may be drawing more than 8 blood gases in a 24-hour period, which exposes the lung to >4 hours of hyperoxemia, which potentially can be damaging to lungs.

MT also notes that the proposed changes do not distinguish between the deceased lung donor that is cared for at the donor hospital or at an OPO’s DCU. MT believes that the location of a donor is critical in determining these proposed changes. Specifically, the testing recommended in Table 2 of the Policy would be challenging to achieve consistently when a donor is in a hospital. Physician practices, policies, equipment availability, and staffing availability vary by hospital, and some hospitals may not be willing or able to dedicate the necessary time and resources towards performing these tests within the specified time frames.

This is particularly true for DCD donors. The hospital attending physician may not be willing to prescribe the proposed vent settings or obtain the blood gases within the times recommended in Table 2 of the Policy. If it is a rapid DCD, there may not be enough time to perform an echocardiogram or have the radiographic interpretation available.

When a donor is declared brain dead and transferred to an OPO’s DCU, the OPO can control the recommended settings and tests performed as recommended by the OPTN. In such cases, MT supports the majority of OPTN’s proposed changes outlined in the Policy. We do suggest that ABG be performed every 6 hours, rather than 4 hours while allocating the lungs, and every 8 hours after lung acceptance.

Therefore, MT recommends that the OPTN considers the location of the donor when making policy changes, given the lack of control OPOs have when a donor is at a hospital versus a DCU.

Region 11 | 09/23/2024

Sentiment: 2 strongly support, 2 support, 4 neutral/abstain, 1 oppose, 1 strongly oppose

Members of the region expressed mixed views on the proposal, with concerns about efficiency and practicality balanced against the need for thorough organ evaluation. There was significant discussion about the proposed testing requirements, which some attendees felt were excessive and potentially burdensome. OPO representatives raised concerns about the feasibility of meeting all the proposed requirements, particularly in smaller or rural hospitals with limited resources. Several attendees suggested that the policy language should be more flexible, allowing for variations in testing based on donor type (DCD vs. brain-dead) and hospital capabilities. The frequency of certain tests, such as the proposed every 4-hour ABGs, was seen as potentially unmanageable given current hospital staffing limitations. Concerns were also raised about the extended case times that additional testing might cause, impacting both donor families and OPO staffing. One attendee shared a personal account of a patient who died from donor-derived cancer, emphasizing the potential life-saving importance of thorough testing. There were also comments about the need for better communication and accountability between OPOs and transplant centers. Some attendees noted that OPOs sometimes fail to provide required testing information, leading to conflicts with transplant centers. The burden on transplant centers was also discussed, with suggestions to limit the number of centers involved in each case to streamline the process. Additionally, there were questions about how disagreements between OPOs and transplant centers would be adjudicated under the new policy.

OPTN Transplant Coordinators Committee | 09/23/2024

The OPTN Transplant Coordinators Committee thanks the OPTN Lung Transplantation Committee for the chance to comment on this proposal. The Committee suggests considering the following:

1. How to implement the recruitment information requirement in DonorNet. The Committee recommends working with the OPTN Contractor IT department to create specific data fields for this information.
2. The impact on rural programs or those with limited staff. The 2-hour testing requirement before the initial offer might slow down organ allocation, as the process may need frequent repetition. The Committee suggests extending this timeframe to 3 or 4 hours.
3. The risks of expanding image sharing beyond DonorNet. The Committee advises caution, as viewing patient data on personal devices like phones or tablets could pose security risks.

International Society for Heart and Lung Transplantation | 09/23/2024

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American Society for Histocompatibility and Immunogenetics (ASHI) | 09/20/2024

This proposal is not pertinent to ASHI or its members.

Region 10 | 09/20/2024

Sentiment: 2 strongly support, 10 support, 6 neutral/abstain, 1 oppose, 0 strongly oppose 

Overall, members of the region are supportive of the proposal. Several concerns were raised about the proposed changes to donor testing and organ offer processes, particularly regarding the clarity of requirements and potential challenges in specific situations. The term "initial offer" needs clarification, and there are concerns about requiring an echocardiogram or right heart catheterization (RHC) before an organ offer. The challenges associated with DCD donors were highlighted, especially the limited control over the donor in such situations and potential complications like lung recruitment loss, which could lead to atelectasis and the loss of viable lungs. It was noted that while the policy aims to standardize processes, there should still be room for communication between donor hospitals, OPOs, and transplant programs in unique situations. There was support for additional testing if it helps get more organs to transplant, but there is caution that an increase in required procedures, such as catheterizations, could lead to more doubts and late declines for lungs that could otherwise be usable. DCDs, in particular, require careful consideration due to family consent, hospital capabilities, and staffing constraints. Further clarity is needed on when testing cannot occur and access to timely testing, particularly in DCD situations that may require a right heart catheterization. Concerns were also raised about the proposed mandate for a chest X-ray (CXR) every 4 hours in DCD patients, with some suggesting a time range around O2 challenges and recruitment maneuvers. Additionally, the availability of Echo and Cath procedures at donor hospitals is a concern. There were also suggestions to include patient positioning (supine or prone) in arterial blood gas (ABG) testing requirements. Overall, while the proposed changes are viewed as an improvement over the current state, they are considered a first step toward standardizing and enhancing donor testing. More rigid requirements for the data posted by OPOs and for programs to respond to available data were suggested to prevent endless additional data requests.

Association of Organ Procurement Organizations | 09/20/2024

AOPO commends the Committee’s efforts to improve the efficiency of lung allocation and appreciates the opportunity to comment on the Committee’s recommendations.

Echocardiogram and Right Heart Catheterization Requirement

While AOPO recognizes that the availability of an echocardiogram or right heart catheterization provides helpful information for the transplant center’s assessment of a lung offer, we encourage the Committee to consider the feasibility of obtaining the exams prior to making lung offers and the impact of the requirement on allocation efficiency. Donor hospital capacity to provide testing and image download for distribution to transplant centers varies, including in large hospitals, and testing may not be available on a 24/7 basis. Requiring OPOs to obtain echocardiograms or right heart catheterization prior to making offers will delay allocation, increase expense, and undermine the Committee’s larger efforts to increase allocation efficiency.

Generally, transplant centers decline lung offers for reasons unrelated to echocardiograms or right heart catheterizations and requiring an OPO to obtain this testing prior to initiating offers (especially in the setting of family time constraints) will cause delays without necessarily adding value to transplant center’s initial assessment of an offer at the initial offer stage. Moreover, in cases where families have imposed time restraints, requiring this testing prior to initiating offers may result in the OPO having to forego offering lungs if the testing cannot be obtained within the family’s time constraints. Maintaining the testing in guidance (vs. policy) or including the testing in policy with a caveat similar to the CT requirement (“if performed”) would be a more appropriate policy choice as it would mitigate the impact on efficiency and maintain the option for the transplant center to request the testing post-acceptance.

DCD Donors

AOPO supports the Committee’s focus on ventilator settings and recommends that the Committee consider and address the difference between DCD and DBD donation pathways. The policy and guidance related to ventilator settings should distinguish between DCD and DBD donors. Approximately 36% of deceased donors in 2023 were DCD donors, and there are components of DCD donor management that are not within the OPO’s control. OPOs do not control ventilator settings for DCD donors and may not be able to meet the 6-8 mL/kg of the donor’s ideal body weight. In addition, the proposal should address donors on a pressure mode where tidal volumes vary based on the pressure delivered by the ventilator or by the patient’s intrinsic respiratory drive.

ABGs

AOPO appreciates that ABGs are important data for transplant centers assessing lung offers. While OPO practice is generally consistent with the Committee’s recommendations (obtained 2 hours prior to the initial offer, at least every 4 hours between the time of the initial offer and organ offer acceptance; and at least every 8 hours between organ offer acceptance and the organ recovery), OPOs are not fully in control of the availability of those results. When traveling for diagnostics, family is visiting at bedside, or the nurse caring for the patient has competing patient priorities, labs may not be drawn in exact timeframes. While an OPO may order or request ABGs within the stated timeframes, their availability ultimately depends on the availability of the patient’s nurse and Respiratory Therapy (“RT”). ABGs require coordination of three components: (i) RT must turn the ventilator to 100% FiO2, (ii) a required 30-minute wait time, and (iii) the patient’s nurse must draw the ABG. Meeting the proposed timeframes may be challenging, if not impossible, to coordinate if the RT is not available or the nurse caring for the patient is delayed in drawing the blood once the 30-minute waiting period has passed. While AOPO supports guidance on these timeframes, we encourage the Committee to consider some flexibility for OPOs when donor hospital resources prevent the OPO from meeting the timeframes.

CT Chest

OPO practice generally includes providing a CT to facilitate transplant center assessment of lung quality when available. AOPO appreciates the Committee’s flexibility in recognizing that CT Chest exams may not be accessible or available at the time of offer in some circumstances and supports the Committee’s approach to moving the CT Chest requirement to Policy, recognizing it may not always be available pre-offer.

OPTN Patient Affairs Committee | 09/19/2024

The Committee appreciated the Lung Committee’s efforts to strike a balance between obtaining accurate information on the donor for the transplant programs to make informed decisions, and the burden on donor hospital staff and OPOs in collecting this information in the required time period. In particular, the Committee acknowledged the burden on smaller community hospitals in meeting these requests. While generally supportive of the, the Committee offers the following questions and feedback for consideration:

• What are the clinical impacts of pushing back the CT scan requirement time from 24-48 hours to 72 hours prior to organ offer? Does the alleviation of OPO burden truly outweigh the insights gained from a shorter time period? What is the reasoning behind not making chest imaging a requirement, rather than just a preference? What are some of the major indicators that would prompt a transplant center to request a follow up heart catheterization?

• Do organ filters have criteria for transplant centers to automatically reject offers that don't contain center specific requirements (they need images, CT, heart catheterization)?

• What is the procedure for the workflows to be adjusted and subsequently monitored? What new metrics will be tracked? 

• If standardization of practice across the system isn't already in place, doesn't that introduce the potential for personal judgement and bias to be injected into the decision?

• Are the changes mainly to increase the number of lung transplants that are successfully completed? Will this improve one's chances of getting a suitable lung transplant? What are the potential downsides to patients from these changes? What does the patient have to do differently to ensure they have the best chance of receiving a lung transplant?

• The change from mycology sputum smear to fungal and bacterial culture results was troubling to one member. While this language is used more commonly in practice, cultures provide more false negative and false positive results that may delay the process or lead to missed infections. The Lung Committee was urged to look at other technologies besides cultures, as there are other FDA-cleared tools that can detect bacterial and fungal infections in a few hours.

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Region 7 | 09/17/2024

Sentiment: 0 strongly support, 7 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

Members of the region expressed concerns about the required testing for DCD (donation after circulatory death) donors, particularly regarding invasive procedures. Several attendees highlighted the difficulties in performing mandatory tests on DCD donors, with specific mention of echocardiograms and right heart catheters. There was a consensus that the policy should be more flexible for DCD cases, with suggestions to either change the requirements to guidance or include language such as "if performed" to allow for exceptions when necessary. There was also discussion on issues related to OPO capabilities and donor hospital limitations. Attendees pointed out that smaller donor hospitals might struggle to meet all the proposed requirements, especially for DCD donors or when there's no clear clinical indication for certain tests. There was a suggestion to clarify the policy on chest X-rays, proposing that the first X-ray should be taken at the start of allocation rather than at the time of offer, with subsequent X-rays every 24 hours. Concerns were raised about the ability of smaller donor hospitals to obtain timely testing, particularly heart catheterizations for DCD donors. An attendee asked that considerations for the varied capabilities of different healthcare facilities be made when implementing the policy. Another attendee noted that the proposed changes seemed to have the potential to reduce wait times and improve allocation efficiency.

Center for Organ Recovery and Education | 09/16/2024

The proposed new testing requirements will have a substantial impact on OPO and hospital staff, especially in smaller facilities. Requiring a right heart catheterization for a lung donor could impose issues at small donor hospitals without the resources to provide that test. Some donor hospitals do not have a cardiac catheterization lab and the OPO will have to travel with the donor to another hospital. Recommend including a statement that the OPO shall make a reasonable effort to obtain the right heart catheterization for lung allocation.

Membership and Professional Standards Committee | 09/16/2024

The Membership and Professional Standards Committee (MPSC) appreciates the work of the Lung Transplantation Committee in developing this proposal and presenting it to the Committee. Several members shared support of the proposal as they felt it would help prevent the use of “stalling tactics” in the offer decision process, but it was also noted that these changes should not preclude transplant programs from requesting additional donor testing or data within reason. Members were supportive of the decision to require either images or an interpretation for the chest x-ray, as there was sentiment that images might be more impactful to the decision-making process for surgeons or clinicians, but the interpretation report also empowers coordinators to make offer decisions and avoid delays.

Members expressed concern about some of the proposed requirements being difficult to comply with in all situations, leading to potential non-compliance even when every effort is being made to follow OPTN policy. Of particular concern was the language requiring that challenge gases not be drawn within 30 minutes of attempting a recruitment maneuver coinciding with the required repeat testing time frame. This is exacerbated in instances of donor instability or when timing is difficult, and the proposed policy may conflict with the needs of an OPO in providing donor care. There was also some concern that particularly in DCD cases, some donor hospitals may be less inclined to deliver on the proposed expectations when OPOs are making the requests, and there needs to be some understanding and flexibility in those circumstances that the current proposed language does not provide. Additionally, it was noted that the proposed policy language does not account for the scenario when a donor is on ex vivo lung perfusion (EVLP), particularly in the requirements for repeat testing of ABGs and chest x-rays, and that needs to be accounted for in future revisions.

Another member was concerned about the timing requirements for the chest x-ray because they work with a donor hospital that will not release images without an interpretation, which sometimes can take up to 8 hours. That would mean under the new proposed language the OPO would either be out of compliance, or the organ allocation would have to be significantly delayed. It was suggested that the use of language such as, “every effort will be made to,” might convey the spirit of the policy without resulting in members being out of compliance for circumstances out of their control.

American Society of Transplant Surgeons | 09/16/2024

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LifeGift | 09/16/2024

LifeGift supports the policy in general in an effort to increase lung utilization and have the following suggestions:

Standardize the challenge ABGs to not longer than every 8 hours (rather than every 4 hours) and make sure to allow for an exception in DCD cases where it may not be possible to collect blood samples. Create a documentation opportunity for position (prone or supine) and peak inspiratory pressure with each ABG result.

We concur on the need for a CT scan as early as possible in the case; however, it may not be practicable in every situation and requiring results prior to allocation could slow organ allocation efforts.

Right heart caths are not possible on DCD cases (in general) and the language should read like the kidney biopsy policy: “OPO will make every reasonable effort to obtain a right heart catheterization if specific criteria are met (e.g., age, history)." Many hospitals do not have 24/7 cath lab coverage and requiring the procedure may have an unintended consequence of reducing lung allocation/utilization. In general, centers should make requests for additional studies within 4 hours of provisional acceptance.

The audit process for policy compliance needs to be carefully updated with this policy requirement to allow for exceptions in documented, realistic situations of hospital non-cooperation, staffing shortages, delays and lack of capability for some of these procedures. For example, some donor hospitals will not release the radiology images until the radiologist has read the images, which at times can be eight hours, or longer.

Finally, we recommend additional OPO expertise on the Lung Committee for this important work as currently there are only 2 positions for OPO professionals.

Thank you for the opportunity to provide feedback.

American Society of Transplantation | 09/12/2024

The American Society of Transplantation (AST) generally supports the proposal, “Promote Efficiency of Lung Donor Testing,” and offers the following comments for consideration:

•The proposal strikes a reasonable balance between informational needs and feasibility but exemplifies the challenges with interventions to improve efficiency split between policy and guidance. The AST agrees that the outlined testing, timeline of testing, and proposed guidance would improve allocation efficiency and decrease the burden on transplant hospitals. Availability of the requested testing provided at the time of the initial lung offer would decrease the need for the transplant hospital to request additional and updated testing, allowing for a timely decision regarding organ acceptance. The policy has enough flexibility in the requirements, acknowledging varying available resources at donor hospitals, prioritizing transmission of vital information for transplant hospitals to decide on lung offer acceptance.

•The AST does not believe that any of the requirements listed in the policy should be moved to guidance. The proposed policy requirements are reasonable and necessary items for determination of lung suitability for transplant. The AST does recommend moving some considerations in the guidance to policy, specifically:

-Information pertaining to bronchoscopy, imaging, echocardiogram, and right heart catheterization that is addressed in both guidance and policy. The AST suggests consolidating this information in OPTN policy to define clearly what is required.

-For pediatric donors, lung measurements are helpful information that should be required by policy.

•The timely availability of the proposed data and images are essential for this proposal to achieve the aims of more efficient organ allocation. The AST recommends that the most recent chest x-ray image be available at the time of the initial lung offer, not just a report. Further, DICOM images are preferred and should be encouraged. Otherwise, the requested testing and timeline is reasonable for the majority of donor lung offers and should be feasible, understanding that there are some donor situations that are more challenging (e.g., DCD donors). The AST requests that the OPTN incorporate defined flexibility for those donor cases in which the donor hospital has limited resources to complete all requirements (documentation of these limitations should be required). Additionally, the AST suggests that the OPTN engage HRSA and CMS about increased scrutiny of existing hospital regulations requiring the available resources to accomplish these evaluation tasks in a timely manner. OPOs in some instances receive immense pushback from hospitals when asked to provide more in depth and more timely evaluations, especially regarding various imaging procedures.

•The AST believes guidance for fungal and bacterial cultures, chest CT scans, chest x-rays, and right heart catheterizations will be beneficial. The AST proposes “bacterial culture results” be changed to “bacterial lower respiratory tract cultures in process” and “fungal culture results” be changed to “fungal lower respiratory tract cultures in process” to emphasize that these cultures may not be finalized and do not need to be finalized at the time of organ offer to avoid allocation delays. Additionally, the AST recommends the inclusion of donor antimicrobial treatment data in this guidance. The AST also suggests that the OPTN Lung Transplantation Committee collaborate with the ad hoc OPTN Disease Transmission Advisory Committee to assess the feasibility of screening for endemic infections in geographic areas of higher prevalence, e.g. coccidiomycosis.

•Defining donor ventilator settings using the evidence based National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Network formula for Ideal Body Weight (IBW) definitions provide much needed guidance and standardization in donor ventilator management needed for donor optimization, ABG interpretation, and efficient allocation. Recognizing that the IBW formulas are validated for adults, how will this be calculated for pediatric donors?

Region 9 | 09/10/2024

Sentiment:  3 strongly support, 6 support, 4 neutral/abstain, 1 oppose, 0 strongly oppose 

Overall, the region expressed support for the proposal.  Several attendees expressed concern about the ability of smaller and/or rural donor hospitals to complete these tests in the required timeframes.  A member also worried about the potential financial impact on OPOs to repeat the tests within the new requirements. An attendee supported the proposed guidance that states preference for imaging rather than reports, as it will be helpful for OPOs when chest x-ray readings are delayed.  The member also stated support for increasing the PEEP to a range of 5-8, as typically hospitals are using a PEEP of 8 as standard.  

Todd Bickley | 09/06/2024

I am in favor of what is being proposed. Furthermore, is any consideration being given to OPTN challenge ABG guidelines that include a PEEP of 5? The reason I ask is becuase we seldom see patients ventilated with a PEEP of 5. Much has changed over time with consideration of what level of PEEP is even therapeutic. Often times patients are on a higher level of PEEP (even if just 8cmH2O because that seems to be the new baseline number) for ventilation. So in order to obtain our ABGs to meet OPTN requirements, we must DECREASE the PEEP to obtain the challenge gas. Even if minimally so, this decrease in PEEP will cause de-recruitment and adversely affect the results of the ABG. This practice seems counter-intuitive.

Anonymous | 09/05/2024

In light of most Organ Procurement Organizations (OPOs) making more aggressive efforts to place lungs for transplant, thus increasing the number of offers being made to transplant centers, I can certainly see the benefit of this proposal. Any initiative that can help with the quality of organ offers and expedite placement is a plus. I have two concerns:
1) Many OPOs continue to be understaffed, thus overworked. I wonder if this proposal will be considered feasible/possible, considering current workloads.
2) As with OPOs, many hospitals are also overworked/understaffed (especially in smaller donor hospitals). Will they have the people power or necessary capabilities to meet the requirements?

Rebecca Baranoff | 09/05/2024

Strongly Support

OPTN Transplant Administrators Committee | 09/04/2024

The OPTN Transplant Administrators Committee appreciates the opportunity to comment on the OPTN Lung Committee’s policy proposal, Promote Efficiency of Lung Donor Testing. The Committee offers the following feedback for consideration:

• The Committee suggests adding peak inspiratory pressure to viewable event settings in the ABG event settings section.

• The Committee mentioned that vital signs donor management indicators in the intake fields are not always filled out, and that fluid management should be included in the testing requirements.

• The Committee suggests adding imaging requirements where possible to increase imaging frequency.

Overall, the Committee is supportive of the Lung Committee’s proposal.

Region 6 | 09/03/2024

Sentiment: 3 strongly support, 8 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Region 6 supported the proposal. During the discussion, an OPO attendee expressed they had no concerns about the changes but noted that some donor hospitals might face challenges with right heart catheterization and the timeliness of CT scans. One attendee recommended making CT scans mandatory. Another attendee did not provide feedback on the proposal but expressed interest in the one-year monitoring update for continuous distribution, specifically how well the modeling predicted organ utilization.

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?"