Read our positions on important transplant issues! Click on each position statement title to access the full document.
Note: Transplant is a rapidly advancing field and our statements are periodically revised.
ASTS Standards and Quality Committee
Approved by the ASTS Executive Committee: April 2023
Because it is the first stage of the organ transplantation process, high quality organ procurement is essential to successful transplantation, and good stewardship of donor family wishes necessitates comprehensive professional training and application
of the highest standards to those who procure organs, particularly in view of the increasing technical complexities of the procedure.
The intent of the following standards for the procurement of organs is to establish criteria by which transplant centers and organ procurement organizations (OPOs) can ensure that, in addition to meeting any applicable licensure or third-party payer requirements, individuals who procure deceased donor organs are appropriately trained to provide the highest quality organs possible from every deceased donor with consistency, safety and professionalism.
Procedural Standards for Deceased Donor Organ Recovery, Approved by the ASTS Council - January 2022
Approved by the ASTS Executive Committee on March 6, 2023\
Definition of the Problem:
The goal of organ transplantation is to save lives and increase quality of life. Critical overarching strategic goals for the transplant community are to increase the number of patients receiving transplants, improve access to transplantation for all, and improve long term transplant outcomes. Improving long term transplant outcomes is central to achieving those strategic imperatives. However, despite enormous success in other phases of the transplant endeavor, dramatic improvements in long term allograft survival have proven elusive. One of the key reasons for this may be that the transplant community continues to monitor allograft function utilizing legacy modalities that often have not changed in decades. For example, in the case of renal allograft function, clinicians still rely primarily on monitoring serum creatinine, urine protein, and donor specific antibody. The emergence of molecular diagnostic techniques has the potential to alter that paradigm and may allow significant improvements in long term allograft function. Our goal in commenting on this topic is to provide clarity for clinicians and advocate for access to these modalities as clinically appropriate for the patients we serve.
Drafted by the ASTS Ethics Advisory Committee, and approved by the ASTS Executive Committee on August 23, 2022
Definition of the problem
Thoracoabdominal normothermic regional perfusion for donation after circulatory determination of death (TA-NRP DCD) utilizes oxygenated machine perfusion for the preservation of abdominal and thoracic organs rather than standard cold perfusion. After the donor has been pronounced and confirmed dead, and after waiting 2 to 5 minutes after the determination of circulatory death to ensure the decedent does not spontaneously resuscitate, the TA-NRP DCD procedure involves opening the chest, central cannulation, clamping of the brachiocephalic vessels and initiation of normothermic oxygenated perfusion to the organs that will be used for transplantation. The procurement proceeds in the same fashion as a brain-dead donor.
Drafted by the ASTS Ethics Advisory Committee on July 1, 2022, and approved by the ASTS Executive Committee on July 5, 2022
The American Society of Transplant Surgeons is deeply concerned with the decision of the Supreme Court in Dobbs v. Jackson Women’s Health that overturns Roe v. Wade, allowing states to legislate the reproductive services that can be provided to women. This decision impacts the sanctity of the patient-physician relationship, interferes with privacy in medical decision making, and will disproportionally impact already vulnerable members of our society. The primary concerns of the ASTS about this ruling are that:
The ASTS supports legislation that protects comprehensive reproductive health care that is evidence based and opposes legislation that interferes with decisions that should reside within the privacy of the patient-physician relationship.
Issued by ASTS, the American Society of Transplantation (AST), and the International Society for Heart and Lung Transplantation (ISHLT) in January 2022.
Community spread of SARS-CoV-2 is waning in some parts of the world, especially in those areas with greater vaccine acceptance, while activity is increasing in other parts of the world due to a variety of factors, including highly transmissible variants and low rates of vaccination. Information about COVID-19 vaccine responses in transplantation is rapidly evolving. Because vaccines are critical to containing further spread of the pandemic, there has been interest in optimizing vaccine responses in vulnerable populations, including solid organ transplant (SOT) recipients.
Drafted by the ASTS COVID-19 Strikeforce on October 8, 2021, and approved by the ASTS Executive Committee on October 18, 2021
The goal of organ transplantation is to improve the health of people with failing organs. The pandemic has been exceptionally challenging for transplant and organ failure patients because of their reduced ability to fight the disease. Lessons learned from the pandemic include that 1) acquisition of COVID-19 in transplant recipients is more lethal than in the general population, 2) COVID-19 disease is mitigated through vaccination, although not as efficiently as in the healthy population, and 3) vaccination is consistent with the routine transplant practice to identify and mitigate conditions known to put an individual recipient at risk.
There are many reasons for routine organ transplant candidate and recipient vaccinations. The obvious is to provide a mitigation of the acquisition of COVID-19 and death. Additionally, transplant candidates and recipients frequently interact with other at risk individuals in the clinic or hospital and if infected can serve as an infectious vector to them. Virtually every candidate for an organ transplant has recognized conditions that increases their risk for severe disease. Additionally, the severity of COVID-19 disease is exacerbated by surgical procedures and in those taking medications to suppress the immune system. “Healthy” transplant recipients taking baseline anti-rejection medications have been observed to have more severe COVID-19 disease. Therefore, “good medicine” is to mitigate against known risks, and vaccination is an effective tool that decreases the risk for the transplant candidate and recipient. Pre and post-transplant vaccination against a wide spectrum of diseases has been routine for years. The medications required for successful transplantation diminish antibody responses (compared to the general population) to vaccinations and COVID-19 is not an exception. Therefore, the ASTS continues to recommend routine vaccination for all organ recipients (with timely boosters) and for those on the waitlist (if possible within time limitations). This mandate is consistent with our pre-existing “routine standards of care” to mitigate known infectious disease prior to organ transplantation.
Drafted and approved by the ASTS Council, April 12, 2021
The American Society of Transplant Surgeons advances the art and science of transplant surgery through patient care, research, education, and advocacy. We view ourselves as patient advocates first and foremost. Dedication to our patients motivates us in our patient care and research endeavors. That same dedication and focus has led us to state the foundational principles that guide our education and advocacy efforts.
Approved by ASTS Council January 12, 2021.
Executive Summary
Over the past several years, it has become clear that current patient and graft survival metrics disincentivize Transplant Center (TC) acceptance of organs at risk of discard and the transplantation of older and less healthy recipients. By discouraging aggressive organ acceptance practices, the current TC metrics create irreconcilable incentives for OPOs and TCs, and limit the number of transplants performed.
While the Centers for Medicare and Medicaid Services (CMS) has discontinued the use of patient and graft survival metrics as a condition of TC recertification, graft and patient survival-related metrics continue to be used by the Organ Procurement and Transplantation Network’s (OPTN) Membership and Professional Standards Committee (MPSC) to trigger TC performance evaluation that may result in the imposition of public sanctions and by the Scientific Registry of Transplant Recipients (SRTR) for the purposes of TC public star ratings. A growing consensus supports the necessity of modifying TC outcomes metrics.
It is critical that any new metrics be developed with the input of the entire transplant community and include input from associations representing transplant surgeons, transplant physicians, OPOs, patient organizations and other affected stakeholders. While metrics used to trigger TC review by the MPSC will be implemented by the OPTN, and while public metrics will be calculated by the SRTR, organizations participating in the development of these metrics should not be limited to the OPTN and SRTR. It is critical that other stakeholders participate in the development of new metric regimes, rather than being relegated to token involvement during the public comment process. All the organizations whose members ultimately will be affected by new metrics should be allowed to participate meaningfully in their development. Without full participation of organizations representing the transplant community, new metrics are unlikely to be fully accepted. Token involvement of the stakeholders central to the initiatives and operations needed to increase the numbers of transplants performed will likely produce suboptimal results. Meaningful involvement in new metrics and flagging parameters by all stakeholders, including the ASTS, is likely to decrease the unanticipated consequences of these inevitably complex policy decisions and maximize the likelihood of successful implementation.
This White Paper outlines ASTS’ position on the development of new TC metrics and includes the following recommendations:
ASTS looks forward to participating with other organizations representing the transplant community in establishing new measures of TC performance designed to meet the needs of transplant recipients and donors.
ASTS White Paper on Optimization of Transplant Center Assessment, January 12, 2021
Drafted by the ASTS Ethics Committee and approved by the ASTS Council February 12, 2021
End stage organ disease results in extensive suffering, death, and cost in the United States and the world.
Presently, sufferers of many types of organ disease may be helped or saved by transplantation:
There is a longstanding discrepancy between the supply of transplantable organs and the numbers of people who need them.
These figures show that transplantable organs are a precious resource, in short supply, and that many people die before having an opportunity to receive this gift.
The American Society of Transplant Surgeons advocates transplanting as many of these patients, as quickly as possible, while also making the most responsible use of our nation’s organ supply. Limiting a transplanted organ’s life expectancy due to placing it with a patient, or in a situation, in which it cannot be adequately supported can deprive another waitlisted patient of a better outcome with the same organ.
To this end, we feel that any medically eligible patient, with sufficient support in place to allow for their adequate care following surgery, should be supported in their pursuit of transplantation.
When a patient presents to a transplant center for evaluation, the center makes a judgement concerning the patient’s medical fitness to undergo the procedure, and also the patient’s expected ability to capably care for themselves and a new organ.
If the patient has cognitive, physical, or financial limitations that would preclude them from being able to adequately care for themselves, then appropriate social supports or other compensatory mechanisms which would remediate the situation should be identified. If these can be found, then the patient’s candidacy for transplantation should be supported. If, however, they cannot be identified, proceeding with transplantation could threaten both the patient’s health and safety, and the longevity of a donated organ. In such a case, further evaluation should be deferred until the limiting issue can be corrected.
As such it is the recommendation of the ASTS that no patient will be discriminated against or precluded from transplant listing solely due to the presence of a disability or handicap, whether physical or psychological. However, if these disabilities lead to a clinical reality where the patient will suffer a great risk of morbidity or mortality from the transplant surgery itself, or the subsequent placement on lifelong immunosuppression, then transplantation would not be recommended. This decision would be made due to the clinical risk benefit analysis for the specific patient, and not on any external factors.
[i] OPTN National Data: https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/. Accessed February 2021.
Drafted by Piotr Witkowski, MD, PhD and approved by the ASTS Executive Committee, December 23, 2020
The issue of declining islet cell transplantation and over regulation emerged from ASTS member Dr. Witkowski.
Definition of the Problem:
Islet allotransplantation in the United States (US) is facing an imminent demise, leaving patients with type 1 diabetes mellitus (T1DM) and severe hypoglycemia without access to a lifesaving therapeutic procedure.
The safety and effectiveness of allo-islet transplantation has been established in NIH-sponsored U.S. clinical trials as well as through the Collaborative Islet Transplantation Registry, U.S. taxpayer-funded research projects, which collectively have analyzed data from more than 2,000 allo-ITx procedures over the past 20 years.
However, despite decades of progress in the field driven by U.S. academic centers, an archaic regulatory framework has stymied U.S. clinical practice. Current Food and Drug Administration (FDA) requirements for allogeneic islets for transplantation do not reflect the clinical or technical state-of-the-art.
The Solution:
We propose to harmonize the U.S. approach to allo-ITx with that of many other countries, which would allow for implementation of safe, effective, affordable, and widely accessible islets for transplantation as a standard of care procedure.
We recommend that the FDA:
We recommend that HRSA, through the United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN), continue to oversee pancreas allocation and procurement and extend its oversight of transplant programs to include those that perform islet transplantation, which would allow HRSA to monitor the outcomes of patients receiving allo-ITx.
The Conclusion:
Allo-islets is a “poster child” for archaic over-regulation. Adjusting the regulation would remove regulatory barriers, reflect our current clinical practice, and deal with our upcoming challenge. ASTS proposes the forementioned updates to current regulations as critical for the renaissance of ethical, safe, effective, and affordable allo-ITx in the United States.
Drafted by the ASTS Ethics Committee and approved by the Executive Committee, September 2020
The issue of surgeons declining to procure organs from HIV+ donors came forth to the leadership of the ASTS who asked the Ethics Committee to address this situation.
Definition of the problem:
HIV was once considered an absolute contraindication to organ donation. As the fields of transplantation and infectious diseases have advanced, protocols have been developed to consider utilization of organs from HIV+ donors, as organs continue to be a scarce resource. It came to the attention of the leadership committee that some surgeons have refused to procure organs from these donors. The leadership asked the Ethics Committee to address this concern.
Drafted by the ASTS Executive Committee, September 2020
The American Society of Transplant Surgeons strongly supports efforts to increase the availability of life-saving organ transplants, which requires increasing the number of organs available for transplantation retrieved by Organ Procurement Organizations (OPOs). ASTS believes it is important not to significantly delay long-overdue modification of OPO metrics, which are currently subjective and self-reported. At the same time ASTS cautions that development of updated metrics must occur with appropriate involvement of the transplant and OPO community, with a thoughtful transition to new metrics that avoids unintended consequences that would adversely affect patients, such as simultaneous decertification of multiple OPOs.
OPO metrics must be put in place based on a potential donor “denominator” that is calculated based on a verifiable, objective methodology.[1] Assuming that no existing accurate alternative source of data reflecting hospital inpatient deaths can be identified, ASTS believes that that the CDC’s National Center for Health Statistics’ Detailed Multiple Cause of Death (MCOD) data (with appropriate exclusions) should be utilized to identify potential donors, and that the transplant community should work with appropriate governmental organizations to address the shortcomings of this database.
When significantly altering a complex system, both short- and long-term impacts must be considered. At least during the transition to the new metrics, care should be taken to ensure that any new regulatory requirements encourage improved OPO performance without resulting in widespread and simultaneous decertification of a significant number of OPOs, which would be inconsistent with the needs of our patients. For this reason, any new system that is put in place should establish realistic standards and should retain sufficient flexibility to enable an OPO that is continuing to make substantial improvement in meeting applicable outcomes requirements to retain certification, so long as it meets threshold and other improvement benchmark required by CMS that are tailored to take into account the circumstances of the particular OPO involved. This will hopefully mitigate the potential disruption and adverse impacts to patients resulting from the decertification of an OPO, while improving OPO performance.
ASTS looks forward to working collaboratively with the OPO community, HRSA, and CMS in future discussions for development and updates on such metrics to ensure continued focus on the goal of maximizing the number of patient lives saved.
[1] Public comments on the CMS OPO Conditions for Coverage Proposed Rule
Drafted by the ASTS Ethics Committee and finalized by the ASTS Executive Committee, June 2020
The issue of conscious DCD came forth to the leadership of the ASTS from a member who inquired whether the ASTS had a policy that would help guide members through these potentially emotionally charged situations. The leadership asked the Ethics Committee to address the member’s concern.
Definition of the problem:
There may be clinical situations in which the patient is able to communicate his/her wishes to be an organ donor upon actions that the patient desires the medical team to make that would facilitate death. Such conditions would include high c-spine fracture and cord injury, amyotrophic lateral sclerosis.