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Quarterly Update of Standardized Benchmark Reports Available

Last November, UNOS research staff made data available to transplant professionals in a fresh new way by enabling them to access standard benchmark reports directly from UNetSM. A quarterly update of this information is now available, which includes a snapshot of the waiting list at the end of December 2016 and transplant data from Nov. 1, 2015 to Oct. 31, 2016.

Transplant administrators, or anyone from your center with UNet access, may access this information. To view the benchmark reports, simply logon to UNet and select Resources from the main navigation bar. Next, choose Data Services from the dropdown items. Then choose My Data Files in the left column.
Having current data delivered regularly will help you understand your patient population, listing practices, and transplant activity and compare it to others in your region and throughout the U.S. Over time, as policies and regulations change, we will update the contents of the report to make sure it provides the most useful information.

We provided this information to many of you previously but in the form of Excel documents, not visual charts that you can easily transfer to PowerPoint presentations or other shared reports. Using private funds, we are able to provide these reports to all transplant centers across the country at no charge, yet if you require advanced or custom reports, we can also create those for a small fee and have already done so for multiple centers.

Important: When we made the most recent quarterly update, we replaced the previous reports. However, if you need a particular archived report or want more information about a custom report, please email benchmark@unos.org or contact the research department through our existing data request process.

Patient safety alert – reports of contaminated organ preservation solution

UPDATED INFORMATION: This is an update to the notice originally posted December 16, 2016. New reports suggest additional lots might be affected.

The Centers for Disease Control released the following report through the Epidemic Information Exchange (Epi-X) on January 12, 2017:

The Centers for Disease Control and Prevention (CDC), Healthcare Resources and Services Administration (HRSA), and Food and Drug Administration (FDA) are investigating potential bacterial contamination of SPS-1, an organ preservation solution distributed by Organ Recovery Systems (ORS). New reports suggest additional lots of SPS-1 might be affected.

Report Description:

This is an update to an EPI-X posted on December 16, 2016, which reported potential contamination in SPS-1 lots PBR-0074-330 and PBR-0060-392. Product from these lots has now been voluntarily removed from circulation by the distributer.

On January 11, 2017, the CDC and FDA were notified by a transplant center in Texas that SPS-1 preservation solution used during an organ procurement procedure had a foul odor. Cultures of the preservation solution were obtained and reported to have grown Gram-negative rods. The SPS solution came from lots PBR-0074-337 and PBR-0060-386, which are different from those previously implicated.

While contaminated preservation solution to date has been associated with an atypical smell, this does not rule out the potential for microbial contamination in SPS-1 without this odor.

Users of SPS-1 should take the following actions:

  1. Do not use SPS-1 from the following lots:
  • PBR-0074-337
  • PBR-0060-386
  • PBR-0074-330
  • PBR-0060-392
  1. Immediately recover any unused product from lots PBR-0074-337 and PBR-0060-386. Sequester product in such a way that it is secured and not prone to further distribution or use.
  2. For any quality issues or post-transplant adverse events among patients who received organs treated with any of the suspected lots:
  • Submit a report to the Organ Procurement and Transplantation Network in the Disease Transmissions section of the Improving Patient Safety portal in UNetSM.
  • File a report with FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online (fda.gov), by regular mail or by FAX to 1-800-FDA-0178 if you suspect contaminated organ preservation products at your facility.
  • Notify local or state health authorities.

U.S. organ transplants, deceased donors set record in 2016

New record set: 33,608 organ transplants in 2016

Organ transplants performed in the United States in 2016 reached a new record high for the fourth consecutive year, according to preliminary data from United Network for Organ Sharing (UNOS). UNOS serves as the national Organ Procurement and Transplantation Network (OPTN) under federal contract. For the year, 33,606 transplants were reported, representing an 8.5 percent increase over the 2015 total and an increase of 19.8 percent since 2012.

“Thousands more men, women and children are receiving a life-saving transplant opportunity each year,” said Stuart Sweet, M.D., Ph.D., President of the OPTN/UNOS Board of Directors. “We are deeply grateful to all who have chosen to help others through the life-saving act of organ donation. We are also very conscious that many more people are still anxiously awaiting a transplant, so we must continue to work with our partners in the donation and transplant community to meet the needs of those who continue to wait.”

The growth in overall transplants was largely driven by an increase of 9.2 percent in the number of deceased donors from 2015 to 2016, continuing a six-year trend of annual increases. Many deceased donors provide multiple organs for transplantation. Approximately 82 percent (27,628) of the transplants involved organs from deceased donors. The remaining 18 percent (5,978) were performed with organs from living donors.

US transplants increased 20% over last five years  

“This increase in organ transplants is partly a realization of an ongoing commitment to improvement at organ procurement organizations, transplant hospitals, and UNOS,” said Brian Shepard, UNOS’ Chief Executive Officer. “Organ transplantation has long been at the forefront of data-driven quality improvement, and OPOs and UNOS are working together on a technology-driven transformation in the way organ donors are identified and recovered.” (See UNOS’ recent public service announcement to promote transplant awareness.)

In addition, an increasing number of deceased donors in 2016 had medical characteristics or a medical history that, in prior years, may have been considered less often by clinicians. These include people who donated after circulatory death as opposed to brain death, as well as donors who died of drug intoxication or those identified as having some increased risk for bloodborne disease.

“While donation and transplant professionals always use their best medical judgment in evaluating donors and organ offers, over the last several years we’ve had success using organs from donors with certain criteria we may not have accepted in the past,” said David Klassen, M.D., UNOS’ Chief Medical Officer. “Among our key goals as the OPTN, working with our members nationwide, is to ensure that as many organs as possible are accepted and used for the patients who will benefit from them the most, while maintaining high levels of patient safety.” (See OPO leaders describe effective practices to increase the number of organs donated.)

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

Phase I of COIIN pilot begins in January

Phase I of the pilot stage of COIIN (Collaborative Innovation and Improvement Network) will begin in January 2017. Visit the COIIN resource page for background information and resources and a current timeline of the project plan.

Nineteen transplant hospitals were selected to participate in the initial pilot phase of the project. COIIN program staff and advisors have completed onsite coaching visits to each of the hospitals to review with them the pilot process, demonstrate the data collection and collaborative learning tools to be used, and prepare them for the Phase I kickoff. Pilot participants will each send representatives to participate in a Phase I kickoff meeting Jan. 10-11 in Richmond, Va.

Phase I of the pilot will involve three action periods for innovation and learning, each focused on a specific topic area: organ offers and acceptance, waitlist management, and care coordination. During each action period, pilot participants will develop and implement a series of 90-day action plans using the PDSA (Plan/Do/Study/Act) methodology. They will track their progress and share information on a collaborative learning website. They will also participate in a virtual learning session to be held in April 2017.

A learning congress will be held near the conclusion of Phase I. The learning congress will focus on key insights and refinements of materials such as the intervention guides. COIIN staff and advisors will incorporate learning and knowledge from Phase I and facilitate discussion with Phase II invitees.

Applications will open in spring 2017 for hospitals wishing to be considered for the second pilot phase of COIIN that will begin in October 2017. Selections for this phase will be made from a combined pool of new applicants and applicants not selected for the first pilot phase. Hospitals who previously applied for consideration will not need to fully re-apply, although updated information may be necessary.

Additional information and updates will be posted soon. For more information, contact Nicole Benjamin, UNOS’ Program Manager for COIIN, by phone at 804-782-4622 or via email at nicole.benjamin@unos.org.

December 2016 board meeting actions

  • News: Board actions
    • Approves revised adult heart allocation system
    • Clarifies exception points for liver transplant candidates with hepatocellular carcinoma 
  • Upcoming policy changes
    • Effective March 1, 2017
      • Post-implementation changes to ABO verification policies
      • Primary transplant surgeon requirement changes
      • Primary transplant physician subspecialty requirement changes
      • Remove donor location from required procurement log info
    • Pending implementation and notice to members
      • HCC auto approval criteria changes
      • Kidney transplant physician update
      • Update transplant hospital definition
      • Modify adult heart allocation
      • Informed consent changes for potential living donors
  • Executive summary of board meeting

Coming soon: OPOs should plan for required toxoplasmosis testing of all donors

At its June 2016 board meeting, the OPTN approved several measures to improve the post-transplant communication of new donor information. One of these measures involved requiring OPOs to test all donors for Toxoplasma IgG.

To make this possible, we are adding a Toxoplasma IgG field to the Infectious Diseases tab in DonorNet®. We expect this new field to be operational by April 2017. At that time, all OPOs will be required to conduct this additional test and report the results.

Your OPO should plan ahead by solidifying any testing agreements with your labs and also plan for any changes needed to record these results in your electronic medical records or to upload them into DonorNet.

For a table summarizing all of the infectious disease reporting requirements for OPOs, see the policy notice. We will continue to notify you as we get closer to the implementation date.

Education

To help you prepare for this new requirement, you can access a learning module on UNOS Connect. You’ll find it in the Course Catalog under the Patient Safety category. Search for Toxoplasma Screening and Reporting of Test Results.