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Committee defines key drivers of system performance

The OPTN/UNOS Ad Hoc Systems Performance Committee met Oct. 29 and 30 in Chicago. Each of the three workgroups (OPO, Transplant Center and Systems Performance) broke into subgroups to define what factors most affect the performance of the transplant system.

Over the next few months, the committee will identify specific metrics, tools, projects and efforts that measure or support system performance.

The committee will present their work at a two-day public meeting March 11 – 12, 2019. Invited speakers will present on related topics and the committee will gather feedback from the audience.

“March isn’t the finish line, but a starting point. The ideas the workgroups generate will be used to measure and improve the transplant system for years to come,” said Matthew Cooper, M.D., System Performance Committee co-chair.

Committee leadership will report to the OPTN/UNOS board of directors at their scheduled meeting in June 2019.

Ad Hoc Committee formed to address OPO, transplant center, system metrics

Liver distribution proposal advances for board consideration

Chicago – The OPTN/UNOS Liver and Intestinal Organ Transplantation Committee, at its meeting Nov. 2, voted to advance a proposal to revise liver distribution policy for a final vote by the OPTN/UNOS Board of Directors at its Dec. 3-4 meeting. The proposal is intended to establish greater consistency in the geographic areas used to match liver transplant candidates with available organs from most adult deceased donors and reduce geographic differences in liver transplant access.
“We believe this reflects a commitment to transplant the most urgent candidates while balancing a number of key issues affecting the liver transplant process,” said committee chair Julie Heimbach, M.D. “We’re committed to closely monitoring the impact of this policy and to making modifications if further optimizations are identified.”
The proposal would replace fixed, irregular local and regional geographic boundaries historically used to match liver candidates based on the donor location. It would initially prioritize liver offers from most deceased adult donors in the following sequence:

  • the most medically urgent candidates (Status 1A and 1B) listed at transplant hospitals within a radius of 500 nautical miles of the donor hospital
  • candidates with a MELD or PELD score of 29 or higher listed at transplant hospitals within a radius of 250 nautical miles from the donor hospital
  • candidates with a MELD or PELD score between 15 and 28 listed at transplant hospitals within a radius of 150 miles from the donor hospital

Livers from deceased donors older than age 70, and/or those who die as a result of cardiorespiratory failure, will be exempt from this distribution. Most of these organs are accepted for local candidates, since they are most viable when the preservation time between recovery and transplantation is short. In addition, this distribution sequence would not apply to livers from deceased donors younger than age 18, which are preferentially considered for pediatric transplant candidates.

The committee further recommended that the implementation of revised liver distribution policy occur no sooner than three months from the pending implementation of a new National Liver Review Board (NLRB), which is scheduled to occur in early 2019. Also, upon NRLB implementation, the committee recommended that standardized exception scores for liver candidates be capped at 28, so that candidates with these scores would not outgain priority for urgent candidates based on calculated MELD/PELD scores. Transplant hospitals, using their medical judgment, may request exception scores higher than 28 from the NLRB for individual candidates.

Simulation modeling of the proposed changes indicate they would reduce variation in transplants by MELD score that exist in various areas of the country under the current liver distribution system. Modeling further predicts that the changes should reduce pre-transplant deaths and increase access for liver transplant candidates younger than age 18. In addition to modeling results, the committee reviewed opinions, recommendations and questions from more than 1,200 public comments submitted between Oct. 8 and Nov. 1.

UNOS wins contract to continue as national transplant network

Richmond, VA – United Network for Organ Sharing (UNOS) has again won a competitive federal contract to serve as the nation’s Organ Procurement and Transplantation Network (OPTN). UNOS has fulfilled this role since the OPTN began in 1986, under contract with the Health Resources and Services Administration of the U.S. Department of Health and Human Services (HHS).

“UNOS is committed to continually improving the nation’s transplant system,” said UNOS Chief Executive Officer Brian Shepard. “Donors, their families, and waiting transplant candidates depend on us.”

Last year, the number of organ transplants in the United States reached a new high for the fifth consecutive year, and the number of transplants is expected to exceed 36,000 in 2018.

All transplant hospitals and organ procurement organizations nationwide are members of the OPTN. The OPTN contract requires a number of critical functions, including:

  • developing and implementing equitable organ distribution policies
  • collecting detailed data on all transplant candidates and recipients, as well as living and deceased organ donors
  • conducting research to improve performance of the national transplant system
  • assisting in organ placement for transplantation
  • monitoring members for patient safety and quality
  • reviewing issues involving potential risks to the health and safety of transplant candidates, recipients and/or living donors

Including option years, the new contract will run through September 2023. Total funding over the length of the contract is estimated to be nearly $250 million. The federal government will fund approximately 10 percent of that amount. The remainder of contract funding comes from fees assessed to individual member institutions.

Areas of additional emphasis under the new contract include:

  • enhancing professional and public involvement in OPTN policy development, such as developing and hosting professional symposia on key policy-related issues
  • continuing to foster innovation in providing projects and services to increase organ utilization and improve the organ matching process
  • furthering the development and use of metrics in assessing the effectiveness of OPTN policy implementation and of monitoring members for patient safety and quality

Separate from its OPTN responsibilities and with private funding, UNOS, a non-profit, 501(c)3 charitable membership organization, leads other efforts to support organ donation and transplantation. These activities include:

  •  collaborating with members on continuous improvement initiatives to strengthen and enhance their work
  • conducting innovative research to increase the number of transplants and enhance transplant outcomes
  • offering information to guide potential living donors, transplant candidates and their caregivers in their decision-making

UNOS is based in downtown Richmond, Va. UNOS is also the home of the National Donor Memorial to honor the spirit and the legacy of organ and tissue donors.

Submitting LAS exception requests for candidates diagnosed with PH

Audience

We are providing this information to all lung transplant physicians, lung transplant surgeons, lung transplant coordinators, UNetSM Site Administrators, transplant program directors, and data coordinators at lung and heart/lung transplant programs. Please share this notice with anyone in your organization who would benefit from this information. This information is also posted monthly on our member website, Transplant Pro.

 Reminder: LAS Revisions were implemented on February 19, 2015

Revisions to the Lung Allocation Score (LAS) were implemented on February 19, 2015. The revisions include policy changes and changes to UNetSM. Visit the toolkit on the OPTN website for resources to help with this transition.

 Submitting Lung Allocation Score Exception Requests for Candidates Diagnosed with Pulmonary Hypertension

 Guideline

Lung transplant candidates diagnosed with pulmonary hypertension (PH) and who meet the following criteria may qualify for an increase in their Lung Allocation Score (LAS):

  1. Patient is deteriorating on optimal therapy, and
  2. Patient has a right atrial pressure greater than 15 mm Hg or a cardiac index less than 1.8 L/min/m2.

To request an increase in a PH candidate’s LAS, transplant programs must submit an exception request to the Lung Review Board (LRB); this request should include sufficient clinical detail to support that the patient meets the above criteria.

If the transplant program believes that its patient has similar waiting list mortality and potential transplant benefit as a PH patient meeting the criteria listed above, then it should provide a detailed narrative on that assertion, referencing literature supporting the request for a higher LAS. When submitting an exception request, transplant programs must provide a clinical justification for the exception. Please refer to Policy 10.2.B (Lung Candidates with Exceptional Cases) for additional information about the exception review process.

Policy 10.2.B allows a transplant program to submit an exception request for an LAS, an estimated value for one of the tests that is used to calculate the LAS, or assignment to a diagnosis group for a disease that is not listed in WaitlistSM.

 Note:  The LRB will render clinical judgment on exception requests for higher LAS, diagnosis, or estimated value.

Transplant programs may wish to submit to the LRB an exception request for the candidate’s LAS to be at the national 90th percentile (see table below).

The LAS for all active candidates greater than or equal to 12 years of age waiting for lung transplants as of October 19, 2018 are as follows:

Aaron McKoy (804) 782-6575If you have questions, please contact the UNetSM Help Desk at 1-800-978-4334 or unethelpdesk@unos.org. You may also contact your review board staff member:

Updates from kidney and pancreas committees regarding geographic distribution issues

Given the importance of addressing issues of geographic distribution in all organ policies, we want to give you more information about the kidney/pancreas initiative. We will continue to update you periodically as events warrant.

A memo from: Nicole Turgeon, M.D., Chair of the OPTN/UNOS Kidney Transplantation Committee and Jon Odorico, M.D., Chair of the OPTN/UNOS Pancreas Transplantation Committee

To: Kidney and Pancreas transplant program directors and administrators and OPO executive directors.

Background
You have already received some general updates from OPTN/UNOS Board leadership on the overall issues of geographic distribution. In short, HRSA has directed the OPTN to develop policies to replace the donor service area (DSA) and region as units of organ distribution with areas that meet provisions of the OPTN Final Rule and principles adopted by the OPTN/UNOS Board in June.

It is important that we address this within the established OPTN/UNOS policy development process. If we cannot, it makes it much more likely that future issues of similar importance will be decided by legal or regulatory means, which may not reflect the expertise and input of the entire donation and transplant community.

Timeline and process
Our two committees are working together on a proposal to revise kidney and pancreas distribution under the guidance of the OPTN/UNOS Executive and Policy Oversight Committees. You may be familiar already with the work in progress on liver and intestine distribution, which is proceeding on a faster timeline.

We are working on a timeline that will include public comment in the regularly scheduled winter/spring cycle and a proposal to bring to the OPTN/UNOS Board in June 2019. This is the same timeline being used to update distribution policies for thoracic organs and vascular composite allografts (VCA).

Below are key policy development milestones as we know them at this point. We will update you with any new or changed dates.
September 2018 – Modeling request to the SRTR
December 7, 2018 – Modeling results available
December 2018 – Public comment proposal finalized
Jan. 21 – March 22, 2019 – Public comment period
June 10-11, 2019 – OPTN/UNOS Board meeting

Frameworks being modeled
Our individual committees, and a work group representing both committees, have met a number of times by teleconference over the last few months. In September we sent to the SRTR, for kidney/pancreas simulated allocation modeling (KPSAM), a series of alternatives to guide a policy proposal. We expect to receive the modeling results in December and will share them with you when available.

Because of the timeframe for all of these efforts, the frameworks we recommended for modeling were developed in parallel with the proposed geographic frameworks recently sent for public comment. Our work, however, has been informed by the discussion to date about the geographic principles and the recommended frameworks.

In the immediate term, we are pursuing distribution based on elements of two different distribution frameworks. One framework involves fixed distance (concentric circle) from the donor hospital. The second is a hybrid of the concentric circles and continuous approaches, where all candidates within a circle(s) receive allocation priority based on the current classification tables but with an additional layer of points related to proximity to the donor hospital. While we are focusing on this model to meet the expedited timetable described above, we may consider future policy refinements, such as a full continuous framework proposal, consistent with the outcome of the Board’s adoption of one or more frameworks. We have asked for modeling results for various alternatives as summarized here.

As with any simulation modeling, we expect the results to address the scope and direction of impacts more than detailed predictions for all circumstances. Modeling may not represent all behaviors involved in the current transplant process and certainly can’t account for potential future behavioral changes. In addition, we may find that the modeling may yield results that affect kidney, pancreas and SPK differently. That said, we will apply the expertise on our committees and seek your input through public comment to determine the best alternative given the current assumptions and timeline. As with any policy, we will closely study its results once implemented and consider any necessary corrections to improve it going forward.

For questions or further information
If you’d like to know more about existing policies, contact your Regional Administrator. You can also find additional resource information and updates on the web pages of both the Kidney Committee and the Pancreas Committee. If you’d like to know more about projects or proposals our committee continues to discuss, contact your regional representative to the committee, or send an e-mail to kidney@unos.org or pancreas@unos.org.

Learn more about National Liver Review Board

Webinar registration opens Nov. 6.

UNOS will implement the National Liver Review Board (NLRB) in early 2019.  UNOS is offering a series of educational events to help you prepare for these changes.  The following chart shows upcoming educational opportunities.  It will be updated as more details are available.

Registration for the December 13 live webinar will open November 6.  To register, visit UNOS Connect.  You can access it through the Home page, or click into the Live Webinar Course Catalog Category. After registration, you will receive a confirmation e-mail with instructions on how to get the webinar link.  If you are attending the webinar as part of a group viewing, you must first register in UNOS Connect in order to receive credit for taking the course.  This event will be recorded and posted to UNOS Connect within seven business days for later viewing.

Please note: Liver distribution policy will be implemented early in 2019 after NLRB.  We will update this article with information on educational offerings relating to liver distribution as they are scheduled.

Date Topic/synopsis How to access/learn more
Dec. 6 National Liver Review Board policy: MELD/PELD exception scoring

In addition to the structure of the new NLRB, candidates meeting the criteria for standardized exceptions will be assigned MELD/PELD exception scores in a different way. This offering explains the new MELD/PELD exception scoring that will be implemented with NLRB in 2019.

UNOS Connect
Dec. 13;
3-4 p.m. (EST)
National Liver Review Board policy: New processes

This live webinar will outline the new review board structure and explain what members need to know about submitting MELD/PELD exception requests, the appeals process, and how existing exceptions and unresolved forms will be transitioned.  The event will be recorded and posted to UNOS Connect within seven business days of the live event.

UNOS Connect
Dec. 18 NLRB training for review board representatives UNOS Connect