Table 1
United Network for Sharing Technological Advancements (UNOS) list of technological innovations.
| YEAR | TECHNOLOGICAL INNOVATION |
|---|---|
| 1992 | UNOS prepares first-ever comprehensive report on transplant survival rates for all active hospitals in the United States. |
| 1996 | UNOS creates the first Transplant Information Electronic Data Interchange (TIEDI) eliminating the step of mailing paper forms to the OPTN. |
| 1999 | UNOS launches UNet, the first internet-based transplant information database system for all organ matching and management of transplant data. |
| 2006 | UNOS launches DonorNet, a secure, internet-based system in which organ procurement coordinators send out offers of newly donated organs to transplant hospitals with potential candidates. |
Table 2
Heart allocation system since 1988. BiVAD: biventricular assist device; IABP: intra-aortic balloon pump; LVAD: left ventricular assist device; RVAD: right ventricular assist device. * Clinical scenario described and risk-stratified in the 2018 allocation system but not specifically included in prior allocation systems.
| 1988 ALLOCATION | 1999 ALLOCATION | 2018-PRESENT ALLOCATION | CANDIDACY |
|---|---|---|---|
| Status 1 | Status 1A | Status 1 | Extracorporeal membrane oxygenation Nondischargeable surgically implanted ventricular assist device Durable LVAD with life-threatening arrhythmias |
| Status 1 | Status 1A | Status 2 | Durable LVAD with device failure IABP Percutaneous endovascular LVAD Surgically implanted nonendovascular LVAD Dischargeable BiVAD/RVAD/total artificial heart Sustained ventricular arrhythmias |
| Status 1 | Status 1A | Status 3 | Durable LVAD (30-day discretionary period) Inotropic agents with continuous hemodynamic monitoring Durable LVAD with complications |
| Status 1 | Status 1B | Status 4 | Durable LVAD without complications Continuous inotropic agents without hemodynamic monitoring Congenital, hypertrophic, restrictive, amyloid, cardiomyopathies* Intractable angina* Retransplants* |
| Status 2 | Status 2 | Status 5 | Dual-organ transplants* |
| Status 2 | Status 2 | Status 6 | All other listed candidates |
Table 3
Current pros and cons of the 2018 heart allocation system.
| PROS | CONS | UNDETERMINED |
|---|---|---|
| Increase in number of transplants | Increase in costs | Increase in temporary mechanical circulatory support |
| Increase in post-transplant 1-year survival | Increase in exception request utilization | Decrease in durable left ventricular assist devices |
| Decrease in waitlist mortality | Increase in ischemic times | Decrease in inotrope usage |
| Long-term survival | Increase in distance traveled | |
Table 4
Attributes under consideration by the Heart Transplant Committee for the first Continuous Distribution Composite Allocation Score.
| MEDICAL URGENCY | REDUCING BIOLOGICAL DISADVANTAGES | PATIENT ACCESS | PLACEMENT EFFICIENCY | |
|---|---|---|---|---|
| Potential attributes | Adult status Pediatric status Waiting time on durable LVAD | Blood type Sensitization | Waiting time Priority for pediatric candidates Priority for prior living donors | Distance between transplant and donor hospital |
| Goal | Prioritize sickest candidates reducing wait list mortality | Increase transplant opportunities for those who are medically harder to match | Promote appropriate transplant access for all candidates | Consider resource requirements needed to match, transplant and transplant an organ |
Table 5
Roles of three organizations in transplantation. CMS: Centers for Medicare and Medicaid Services; HRSA: Health Resources and Services Administration; OPTN: Organ Procurement and Transplantation Network; SRTR: Scientific Registry of Transplant Recipients; OPOs: organ procurement organizations
| ORGANIZATION | ROLE |
|---|---|
| OPTN | Maintain an equitable organ allocation for patients on the national waitlist governed by the National Organ Transplant Act and the Final Rule. They can include changes to allocation policy, bylaws, data collection, member requirements, guidance documents, and patient education materials. OPTN committees initiate all projects. |
| HRSA | Award contracts to operate and oversee the contractors for OPTN and SRTR. SRTR conducts advanced statistical analysis of OPTN data. HRSA’s Final Rule also requires the Secretary of Health and Human Services to approve proposed policies prior to implementation that the OPTN Board recommends be enforceable. |
| CMS | Certifies and regulates OPOs, evaluates OPTN member standing of transplant programs, requires donor hospitals to report to OPOs patient-level data of transplanted individuals who have died in the hospital, and regulates all laboratory testing including histocompatibility laboratories. CMS can decertify OPOs and suspend payments/reimbursements of transplant programs and histocompatibility laboratories if they do not comply with established requirements. |
Table 6
Organ Procurement and Transplantation Network modernization aims.
| Technology | Continual focus is on improved IT system functionality and security while ensuring continuity or services and protecting patient safety. |
| Data Transparency and Analytics | The modernization process provides easily accessible, high-quality and timely data to make informed patient, donor, and clinical decisions. It also measures and evaluates program performance and helps inform oversight and compliance activities. |
| Quality Improvement and Innovation | The OPTN promotes a culture of quality improvement and innovation across the network by leveraging timely data and performance feedback, collaborative learning, and strategic partnerships. |
| Governance | The OPTN Board of directors is high-functioning and has greater independence. It also represents diversity of communities and delivers effective policy development. |
| Operations | The OPTN is effective and accountable in its implementation of organ policy, patient safety, compliance monitoring, organ transport, OPTN member support, and education of patients, families, and the public. |
Table 7
HRSA-OPTN modernization contracts and goals to date. HRSA: Health Resources and Services Administration, OPTN: Organ Procurement and Transplantation Network
| GOAL | COMPANY AWARDED | VISION |
|---|---|---|
| Improving patient safety | Arbor Research Collaborative for Health | Will address patient safety and the policy compliance systems and processes to improve oversight of the multiple entities in the OPTN. |
| Supporting OPTN IT modernization | General Dynamics Information Technology Inc | Will focus on opportunities to improve the OPTN organ matching IT system and inform HRSA’s Next Generation IT procurement and development. |
| Increasing transparency and public engagement in OPTN policy development | Maximus Federal Services | Will provide advance opportunities to improve public visibility and engagement in the OPTN policy-making process. |
| Strengthening patient-centered communications | Deloitte Consulting | Will focus on improvements in communications from the OPTN, within the OPTN, and patients/families. |
| Improving OPTN financial management | Guidehouse Digital | Will address improvements for OPTN’s budget development and management systems and processes. |
| Improving organ transplantation logistics and transportation | MITRE | Will work to develop system requirements to improve how organs are transported safely including how to ensure trackability during transport. |
| Evaluating organ allocation policy | MITRE | Will work to develop an evaluation framework to assist HRSA in assessing organ allocation policy effectiveness. |
| Program management, data partnerships and analysis | Summome | Will provide comprehensive program management support and work with HRSA to coordinate multi-vendor OPTN activities and performance. |
Table 8
Concerns raised by the American Society of Transplant Surgeons with respect to the future board of the Organ Procurement and Transplantation Network. NOTA: National Organ Transplant Act; OPTN: Organ Procurement and Transplantation Network
| CONCERN | REASONING |
|---|---|
| Who are the nominating committee members? | Representation of stakeholders on the OPTN Board needs to be determined by a Nominating Committee that has earned the respect and trust of the transplant community. Importantly, the Nominating Committee needs to include individuals with experience and expertise in organ acquisition and transplantation that is necessary to assess the qualifications of potential nominees. |
| Will there be political influence in decision making? | The OPTN was established as a public-private partnership to ensure that highly sensitive policy decisions related to patient access, safety, and quality are made by the clinical and patient communities, independent of political influence. There is growing concern that decisions from the board may impact different regions differently and therefore become politically influenced or sensitive as the nominating committee is chosen through a closed process by government officials subject to political pressure. |
| Does the process of a nominating committee violate NOTA and Final Rule? | The OPTN Board and Executive Committee have requested HRSA verify the legality of HRSA’s special election process as there are concerns that this process is not consistent with NOTA and the Final Rule. |
| By eliminating current or recent board members from the OPTN Board, are we setting up the system for success or failure? | The limited Nominating Committee and Board selection criteria made public by HRSA indicates that anyone who served on the OPTN Board during the past 10 years will not be considered, based on “conflict of interest.” Ten years seems to be arbitrary, and this may leave the Board of Directors without any understanding of institutional history and expertise. |
| Why is there a lack of transparency, communication, and opportunities for change with constructive feedback from patients, societies, and OPTN? | To date, an overall sentiment is that HRSA has not involved structured opportunities for input from key stakeholders. This lack of engagement can create a disconnect between decision-makers and the operational realities faced by those in the field. |