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New Intestine Program Applications and Bylaws

New Intestine Program Applications and Bylaws

Update: the program application date has been extended to April 30, 2018.

The OPTN/UNOS Board of Directors approved bylaws in June 2015 defining a designated intestine transplant program and establishing minimum qualifications for primary intestine transplant surgeons and physicians. The implementation of these bylaws was delayed to allow for the development of new application forms and the approval of those forms by Office of Management and Budget (OMB). The OMB has recently approved the new intestine transplant program applications.

As described in the Policy Notice issued in July 2015, UNOS will send the OPTN intestine program application and an opt-out form to all transplant hospitals with an intestine program with a current status of “Active, Approval Not Required.” All transplant hospitals with an active intestine transplant program will be asked to either complete and submit the intestine application form or submit the opt-out form within 120 days.

If your transplant hospital does not intend to apply for an intestine transplant program, use the opt-out form to document your intention. If your transplant hospital does not receive an application but wishes to apply for an intestine transplant program, send a request to [email protected] to get an application and the necessary instructions.

The effective date of the intestine transplant program bylaws will coincide with the date that the Membership and Professional Standards Committee acts on all intestine transplant program applications received during the 120 day submission period.

Once the Bylaws are implemented, if your transplant hospital does not have an approved intestine transplant program, but you have intestine or liver-intestine candidates on your waiting list, you must follow the patient notice and transition plan requirements described in OPTN Bylaws Appendix K (Transplant Program Inactivity, Withdrawal, and Termination)

The new bylaw language can be found in the Membership and Personnel Requirements for Intestine Transplant Programs policy notice on the OPTN website.

UNOS will implement the membership and personnel requirements for intestine transplant programs on the following schedule:

October 2, 2017

  • UNOS Membership Analysts will send communication with applications and opt-out forms to transplant hospitals with an intestine program with a current status of “Active, Approval Not Required.”

April 30, 2018

  • Due date for all intestine transplant program applications or opt-out forms for consideration before the bylaws are implemented. If we receive your application after this deadline, we cannot guarantee it will be processed prior to the implementation date.

July 19, 2018

  • Latest possible effective date of intestine transplant program membership and personnel bylaws. Notice will be provided 30 days prior to the effective date.

If you have any questions, please contact Christi Manner, Jasmine Smith or Tierra Simpkins by phone at (804) 782-4800 or by email using the format [email protected].

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Board approves enhanced liver distribution system

Board approves enhanced liver distribution system

Atlanta – The OPTN/UNOS Board of Directors, at its meeting December 4, approved a set of policy amendments to reduce geographic differences in liver transplant candidates’ access to a timely transplant.

“Today’s action is an important step in enhancing equity for liver transplant candidates nationwide,” said Yolanda Becker, M.D., president of the OPTN/UNOS Board of Directors. “For many years, there have been considerable differences from one area of the country to another in terms of how sick most liver candidates need to be before they are likely to get a transplant. The revised policy reduces the effect of geography on transplant access and puts more appropriate emphasis on medical criteria that save and lengthen lives.”

The policies approved by the Board include the following key provisions:

  • Additional transplant priority (equivalent to 3 MELD or PELD points) will be awarded to liver candidates with a MELD or PELD of at least 15, and who are either within the same Donation Service Area (DSA) as a liver donor or are within 150 nautical miles of the donor hospital but in a different DSA.
  • Adult candidates who have a calculated MELD score of 32 or higher, as well as pediatric candidates younger than age 18 with a MELD or PELD score of 32 or higher, would be prioritized for organ offers.
  • Livers from deceased donors who are age 70 or older, or who die of cardiorespiratory death, would not be subject to offers to the expanded DSA plus proximity circle. Livers from donors with these medical characteristics are most often transplanted at hospitals nearby to the donor hospital.

Simulation modeling of the likely effects of the revised system suggests it will decrease pre-transplant deaths among liver candidates and increase transplant access for candidates younger than age 18. The modeling does not suggest the system will greatly affect transplant access based on candidates’ insurance type (public or private). Similarly, the modeling does not suggest the system will greatly affect transplant access whether candidates live in urban settings as opposed to suburban/rural areas.

“We will closely study the effects of the system, even prior to implementation and continuing as long as it remains in place,” added Dr. Becker. “Every transplant policy is reviewed for intended and unintended effects. Through the OPTN policy-making process, we’ll continue to seek ways to make the policy work most effectively and address any issues that suggest it’s not giving everyone similar benefit.”

The action is the result of a five-year process of study and discussion. (See a timeline of key events in development of liver policy.) The OPTN/UNOS Liver and Intestinal Organ Transplantation Committee held two public forums and considered several distribution concepts. The proposal approved by the Board was initially distributed for public comment in July 2017; several details were amended as a result of public input.

An implementation date for the new system has yet to be established; it will require time to allow for system programming and testing, as well as education for donation and transplantation professionals.

United Network for Organ Sharing (UNOS) serves as the national Organ Procurement and Transplantation Network (OPTN) under contract with the Department of Health and Human Services, Health Resources and Services Administration. The OPTN brings together medical professionals, transplant recipients and donor families to develop national organ transplantation policy.

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At two years, HOPE Act still offering hope

New Intestine Program Applications and Bylaws

Two years since its implementation, the HIV Organ Policy Equity Act (also known as the HOPE Act) has continued to provide transplant opportunities for candidates with HIV who are willing to accept organ offers from HIV-positive donors.

As of November 20, 2017, 34 transplants had been performed at six hospitals participating in HOPE Act protocols. This included 23 kidney transplants and 11 liver transplants, involving organs from 14 deceased donors.

“This is a significant advance in organ donation and utilization,” said Cameron Wolfe, M.D., chair of the OPTN/UNOS Ad Hoc Disease Transmission Advisory Committee. “While the early trend in transplants remains somewhat modest, people living with HIV are able to be organ donors, where for decades they were prohibited from doing so. I have worked with patients who feel empowered by the idea of one day being a donor for another person living with HIV. And transplanting organs from these donors into HIV-positive candidates also means more organs from HIV-negative donors are available for HIV-negative recipients.”

The HOPE Act, signed into law Nov. 21, 2013, called for the use of organs from HIV-positive donors for transplantation into HIV-positive candidates under approved research protocols designed to evaluate the feasibility, effectiveness and safety of such organ transplants. The provisions of the Act were made effective on Nov. 21, 2015.

As of November 20, 2017, 22 transplant hospitals have enrolled with the OPTN to participate in HOPE Act research, and approximately 200 candidates are currently listed as consenting to receive organ offers from HIV-positive donors.

Any participating hospital must conduct transplants under IRB-approved research protocols conforming to the Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected with HIV, which were developed by the National Institute of Allergy and Infectious Diseases, one of the National Institutes of Health.

Organ procurement organizations are able to run matches for HIV-positive donors. The only candidates who will appear on match runs for these donor offers will be those listed at transplant programs that have an IRB-approved protocol, and whose HIV status and willingness to accept an HIV positive kidney or liver has been confirmed.

“The transplant community is closely monitoring outcomes of these transplants, both to ensure the safety of patients involved and to see whether their transplant outcomes are similar to recipients of HIV-negative organs,” said Dr. Wolfe. “This information will help the transplant community understand the impact of using HIV-positive donor organs and how we can help patients make decisions that offer them the most benefit.”

Learn more about the HOPE Act and related OPTN policy. See additional data and information in this UNOS article.

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Policy modification to lung distribution sequence

Policy modification to lung distribution sequence

Summary

Effective at 8 p.m. Eastern time, November 24, 2017, the OPTN lung allocation system was modified to replace the Donation Service Area (DSA) as the first level of distribution with a 250 nautical mile circle around the donor hospital.  The OPTN/UNOS Executive Committee authorized this action in response to an emergent directive from the Secretary of the U.S. Department of Health and Human Services.

Background

On Monday, November 20, the U.S. Department of Health and Human Services (HHS) directed the OPTN to conduct an emergent review of lung allocation policy.  HHS requested the OPTN to review and address by Friday, in response to a court-ordered deadline, the rationale for using the DSA as the first level of distribution, given the arbitrary nature of DSA boundaries and the potential that urgent transplant candidates in close proximity to organ donors may not get immediate priority if they are across a DSA boundary.

The OPTN/UNOS Executive Committee deliberated the HHS directive, with input from the OPTN/UNOS Thoracic Organ Transplantation Committee.  While geographic proximity of donors and recipients is linked to successful lung transplant outcomes due to ischemic time constraints, DSAs vary considerably in size and population.

The Executive Committee responded to the HHS directive by a unanimous vote on November 24 to approve a policy proposal that maintains the concentric circle approach used in thoracic allocation policy and allows for local utilization, but with a more consistent approach than using DSAs as the initial distribution area.  The Committee proposed to HHS that a circle of 250 nautical miles surrounding the donor location would best address the critical comment.  HHS has accepted this solution.

While the Executive Committee can act on emergent policy issues, any policy action the committee makes is subject to additional review and potential revision through the OPTN policy-making process.  The policy is set to expire in one year to allow the Thoracic Organ Transplantation Committee to study the effects of the policy revision and make additional recommendations, including public comment, to the OPTN/UNOS Board of Directors.

Implications for members

This revision affects only the initial distribution sequence of organ offers for lung candidates.  It does not affect any other provisions in policy, such as LAS scores, donor and candidate testing, diagnosis groups or reporting of data.  After candidates receive offers within a 250-mile radius, there is no change to additional distribution zones (A, B and C).

Any organ offers that precede the time of implementation should continue according to the sequence as identified on the original match run, even if the offer process continues after the implementation of the new sequence.

Depending on the association between donor and candidate locations, some areas will experience changes in candidates prioritized on local matches, potentially including a higher number of lung offers.  We encourage OPOs and transplant centers to work together in a time-sensitive manner to minimize the likelihood of organ wastage.

For further information

Please contact your Regional Administrator if you have questions.

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UNOS Organ Center at 35: A vital link with the transplant community

What has been in continual operation, 24 hours a day, seven days a week, for the past 35 years?

The World-Wide Web? Nope, not even 30 years old yet.

The Energizer Bunny? A mere 28.

Amazon.com, Facebook, Bluetooth devices? Not even close.

But since July 1982, the UNOS Organ Center has been working every hour of the day and night to help organ procurement organizations and transplant hospitals make transplants happen. In fact, many transplants would not have been possible without the skill and dedication of the Organ Center staff.

The Organ Center’s history actually predates UNOS as an organization. It was founded by the Southeastern Organ Procurement Foundation (SEOPF) as the Kidney Center. Initial financing came through a grant from the American Kidney Fund.

When UNOS was incorporated in 1984, the Organ Center became one of its most fundamental services. Over time, its role has grown to include four primary responsibilities:

  • Placing organs for transplantation
  • Arranging transportation for organs
  • Maintaining the national transplant waiting list
  • Providing informational and logistical support to the U.S. transplant community

Many of UNOS’ longer-term employees have worked in the Organ Center (sometimes known informally as the “OC”) and have experienced many changes over time. “When I started in the Organ Center, we did not have electronic notification,” said Kim Betancourt, a senior Organ Placement Specialist (OPS). “We had to go down the match and call each center and verbally tell them about the donor. It was very rare that we ever got through an entire match, where today, we get through a match so much quicker.

“With electronic notification, I feel like I place more organs than I used to,” Betancourt added. “I have also noticed more centers are pumping kidneys and, with that, surgeons are accepting kidneys that may have more cold time.”

Despite the changes, those who are newer to the Organ Center appreciate the continuity and mentorship of their longer-term colleagues. “I am so appreciative that I have been welcomed into such a great community,” said Jennifer Harter. “The more senior OPS’s and even the relatively new ones have really taken me under their wing. It is very apparent that the core values of UNOS are really second nature within the OC. Everyone is willing to lend a hand or answer any question, no matter how simple.”

Organ Center staff have a unique connection with many UNOS members through their interactions at any hour of the day or night. Many form deep bonds with clinicians and staff, even if they’ve never met in person. “You do create relationships, even over the phone,” said Sandy Batts Starr. “When you talk to someone for what seems like 100 times in one day, three days a week, 52 weeks a year, you feel like you know them. We commiserate, joke around with each other, find a minute to make someone’s day when an impossible transportation becomes possible. And now we have social media, so we “see” each other more often than once a year in the holiday photo that is sent out.”

Staff members must sometimes confront tense and difficult situations. They are onsite and available despite conditions caused by weather or widespread power outages. (The Organ Center has a number of power and computer backups, and if needed can relocate quickly to a remote site to continue operations).

They have also faced unexpected challenges as a result of tragic events. Lori Gore was in the Organ Center on September 11, 2001. “Like the rest of the country we were horrified; we called loved ones, and for 30 minutes the phones were silent. And then all hell broke loose – the government grounded all aircraft that were up in the air at the time, so planes with organs were coming down everywhere across the country without recipients lined up where they were landing.

“We were scrambling, running import matches, calling centers, talking with courier services – trying to make sure that even though nothing was where it was supposed to be, nothing more would be lost,” Gore added. Due to the efforts of transplant professionals nationwide, including the vital support of Organ Center staff, no candidate deaths are known to have occurred as a direct result of the flight ban.

Despite the occasional crisis, the usual atmosphere is calm and professional. “While I didn’t expect the Organ Center to be quiet,” said Octavia Goodman, “I did expect it to be more chaotic. I thought the phones would be ringing off the hook and that the OPS’s would be flustered and tense from working in an environment that plays a role on an individual’s quality of life. To my surprise everyone was very calm and managed their cases very efficiently, regardless of what was going on.”

Above all, Organ Center staff feel a keen sense of responsibility and connection to UNOS’ role in donation and transplantation. “There has never been a time when someone asked what I do or where I work that I haven’t been proud to say ‘UNOS,’” said Britt Thompson. “In each of those instances they have commented that they are registered donors and they have a personal story to share of giving or receiving. I can’t imagine going back to a job where I can’t see value in the work of which I am a small part.”

View additional perspectives from organ center staff.

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Odds for receiving a kidney transplant now equal for black, white and Hispanic candidates

Recent improvements in national kidney transplant policy have evened the rates at which African-American, Hispanic and Caucasian transplant candidates receive kidneys from deceased donors, according to data from United Network for Organ Sharing (UNOS). UNOS serves as the national Organ Procurement and Transplantation Network (OPTN) under federal contract.

“This marks a major milestone in transplantation in the United States,” said Mark Aeder, M.D., immediate past chair of the OPTN/UNOS Kidney Transplantation Committee. “For many years African-American and Hispanic candidates weren’t being transplanted at the same rate they represented among patients on the national waiting list. That imbalance has now disappeared.”

Kidney transplants by recipient ethnicity

The findings stem from a recent analysis of effects of a kidney allocation system (KAS) implemented in December 2014. The new policy was intended to increase equity in access to kidney transplants and promote more effective utilization of available organs. The analysis shows progress on many key goals in the first two years of the new system.

As of November 30, 2016, 36.7 percent of candidates awaiting a kidney transplant were Caucasian, while 36.7 percent of deceased donor kidney recipients from December 2015 through November 2016 were Caucasian. For the same time frames, African-Americans represented 33.3 percent of waitlisted candidates and 34.5 percent of deceased donor kidney recipients; also 19.5 percent of waitlisted kidney candidates were Hispanic, while 19.5 percent of kidney recipients were Hispanic.

“The transplant community has striven for many years to close ethnic gaps between people who are listed for a kidney and those receiving them,” said Jerry McCauley, M.D., M.P.H., FACP, immediate past chair of the OPTN/UNOS Minority Affairs Committee. “African-Americans and Hispanics are at higher risk for developing end-stage kidney disease than other ethnicities, and thus they’re listed for kidney transplantation at a rate higher than they represent in the U.S. population. KAS appears to have closed the final policy gap. Minority candidates still face challenges, as they often are not referred for transplant as quickly as others and can take longer to complete their evaluations. Once they are listed, the new allocation system provides equal access to transplantation.”

“This is an important achievement not only for minority candidates, but for trust in the national transplant system,” said Sylvia Rosas, M.D., MSCE, chair of the OPTN/UNOS Minority Affairs Committee. “Everyone needing a transplant depends on someone else’s personal decision to become an organ donor. It helps in donor education and outreach to know that our diverse communities have a fair chance to benefit from a transplant.”

One factor accounting for part of the change is a rising trend of deceased donation among African-Americans and Hispanics, which provides more transplant opportunities for minority candidates. “It’s not essential to match the ethnicity of donors and recipients,” said Dr. McCauley, “but people who share a similar heritage sometimes are more immunologically compatible.

“About 20 years ago,” Dr. McCauley continued, “African-Americans and Hispanics donated organs at a rate somewhat lower than they represented in the U.S. population. Today the ethnic makeup of donors is essentially the same as the population. This reflects the success of outreach by many organizations and donation advocates to engage minority communities and address their specific questions and concerns about the donation process. The OPTN/UNOS Minority Affairs Committee has also worked for many years to ensure the unique needs and perspectives of minority populations are fully considered by the transplant community.”

UNOS, in its role as the OPTN, has continued over time to refine kidney allocation policy to improve equitable access to transplantation. Prior to KAS implementation, several changes to kidney allocation policy have reflected emerging science in histocompatibility and immunology – the matching of immune system compatibility between organ donors and recipients.

“Our immune system represents one of the most complex biological processes known to man,” said Robert Bray, Ph.D., chair of the OPTN/UNOS Histocompatibility Committee. “Immune system compatibility between a donor and recipient is important in all of transplantation, but it’s most critical for the success of kidney and pancreas transplantation. Over the past 25 years, we have made great strides in our understanding of the specific aspects of immune system compatibility that have greatest impact on transplant success, as well as major advances in immune-suppressing medications to combat rejection once transplanted.

“When the national transplant network began in the late 1980s, complete immunologic matching was believed to be required,” said Dr. Bray. “Over the years, our research has shown us two important things. First, selected aspects of immune compatibility seem to be most important. Second, requiring complete compatibility matching could disadvantage minority candidates as ethnic heritage can influence what antigens – immune system markers – we each have. Since the great majority of deceased donors were Caucasian, it was likely that they would not match as closely with candidates of other ethnic groups.

“Several times over the last two decades, we’ve refined kidney policy to give allocation priority to those immunological combinations that are most likely to result in a long-term successful transplant,” Dr. Bray added. “These changes, combined with policy changes related to how we assess waiting time and how we prioritize access for the highly sensitized candidate, have all broadened the opportunity for minority patients to be considered for the available kidneys.”

While the current data are encouraging, “Much more work needs to be done,” noted Dr. Aeder. “We’ve improved transplant access for the ethnic groups that make up the great majority of the waiting list. But there is still a noticeable gap between listing and transplant rates for people of Asian heritage. We will continue to study how to improve access for everyone, regardless of ethnicity, age or other factors.

“And our greatest challenge – ensuring everyone who needs a transplant can receive one – is still uppermost for us,” added Dr. Aeder. “The good news is that through increases in the selfless gift of organ donation, we are transplanting more people each year. In fact, in the two years since KAS was implemented, kidney transplantation has increased more than nine percent nationwide. But tens of thousands of people remain in need today. We rely on the public’s commitment to help them through organ donation.”


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