Donor Alliance is the federally designated, non-profit organ procurement organization (OPO) serving Colorado and Wyoming. As a recognized leader in facilitating the donation and recovery of transplantable organs and tissues, our mission is to save lives through organ and tissue donation and transplantation. Our community depends on us during some of the most vulnerable times in their lives. Those waiting for a transplant rely on us for a second chance at life, while the families of donors depend on us to honor their loved ones’ heroic decisions to become donors. Meeting these needs is the foundation of all that we do.
Donor Alliance works every day to maximize organ donations and bring lifesaving organs to those on the transplant waiting list. We continue to pursue innovation and process improvement that maximize the gift of life, and our commitment to excellence and performance improvement is evidenced by our performance excellence journey and 2018 Malcolm Baldrige National Quality Award, the highest level of national recognition for performance excellence that a U.S. organization can receive. The award program noted that Donor Alliance consistently outperforms the top 25 percent of organ procurement organizations for donor designation and demonstrates a commitment to mission at every opportunity.
2019 was the most lifesaving and healing year our region has ever seen, with 596 lives saved through organ donation and thousands more saved and healed through tissue donation. We facilitated more organ transplants than ever by 22%, exceeding the previous high set in 2018 and marking the fifth consecutive year of growth. Last year’s record-setting 2,118 tissue donors also represented a 26% increase over 2018 and translated into thousands of lifesaving and healing tissue transplants. Colorado and Wyoming are regularly among the leaders in the nation in donor designation rates, or percentage of individuals joining the state donor registries. This progress didn’t happen overnight, or as a result of improvements made in one year. We credit our region’s continued success to strong partnerships, our mission-driven approach and dedication to process improvements, which have been ongoing for more than a decade. And of course, none of our work would be possible without the kindness and selflessness of donors and their families, who give the gift of life.
The field of organ donation and transplantation is one of the most regulated areas of health care today. Both state and federal legislation has been put in place to provide the safest and most equitable system for allocation, distribution, and transplantation of donated organs. Multiple government agencies regulate aspects of the organ donation and transplantation system, including Centers for Medicare & Medicaid Services (CMS) who is charged with conducting reviews and certifying OPOs based on the Conditions for Coverage, including outcome and process measures. CMS updates the OPO and transplant center regulations periodically to avoid unnecessary burden on healthcare providers while ensuring safe, high-quality care.
Signed in July 2019, the Executive Order on Advancing American Kidney Health launched a number of efforts with the collective goal of improving medical care, including establishing new measures for OPOs. Donor Alliance supports valid and continually improving performance metrics, that are based on sound data.
The performance threshold for OPOs is set at the 25th percentile, which will ensure a high number of OPOs will not meet the metrics and therefore be eligible for decertification. If the purpose of the program is to help OPOs improve their performance in order to increase organ donation and transplantation, decertifying 75% of OPOs in a given year could destabilize the U.S. organ donation and transplantation system and potentially lead to the loss of lives.
Recommendation: Establish a performance threshold for the donation and transplantation rate based on a specified standard deviation from the mean.
Rationale: Using a standard deviation threshold would more accurately and fairly assess OPO performance. It balances the need to incentivize continual improvement while establishing a rational basis for the threshold as
supported by the data and valid statistical methodology.
Studies show that 30-60% of death certificates inaccurately report the cause of death. In addition, death certificates show primary cause of death and inconsistently document secondary conditions such as if the deceased donor was COVID-19 positive and therefore ineligible for donation. For example, a patient can die of a head trauma from an accident but be infected with COVID-19 or have metastatic cancer and this would not be noted in the death certificate. As a result, the death would be mistakenly included in the calculation of potential donors. Such a patient would not actually be medically acceptable for donation.
Recommendation: Use inpatient ventilated deaths as the data set for donation rates.
Rationale: A potential donor must be on a ventilator in a hospital at the time of death for organ donation to occur. The calculation of a donation rate should include only these inpatients for the most accurate performance
And finally, the two proposed metrics share the same data source as a denominator: death certificates. Because of this, they are based on a faulty data set AND statistically highly correlated. Stated another way, both metrics measure the same thing and in effect there is only one measure, not two. Measuring the performance of an organization based on only one measure will not provide an accurate view of their actual performance.
Recommendation: Retain the current Observed to Expected (O:E) Yield measure as the measure of organ transplantation rates.
Rationale: The observed versus expected ratio calculates the number of organs expected to be transplanted from a given donor (based upon data from actual donors) and compares it to the number of organs the OPO actually recovers and provides for transplant. If the ratio is 1.0, the OPO is performing as expected, if the ratio is > 1.0 the OPO is exceeding expectation, and if the ratio is < 1.0 the OPO is performing below expectation. Retaining this metric would also satisfy the statutory requirement for OPOs to be evaluated based on multiple metrics.
Join our campaign to encourage the Department of Health and Human Services (HHS) to address our concerns with proposed metrics.
Submit an email to your elected officials through AOPO’s Take Action portal.