Examining the future of the U.S. organ procurement and transplantation network

By Seth Karp, M.D.

The following is an edited version of testimony given before the U.S. Senate Committee on Health, Education, Labor and Pensions.

I want to briefly tell you about a patient waiting for a liver transplant who represents the tens of thousands of patients depending on reform of our system: Jill Chance has consented to have her story shared.  She is a 48-year-old woman whose priority score for liver transplant does not reflect the severity of her illness.  She is in and out of the hospital with infections in her liver, and lives with drains coming out of her abdomen.  She is looking forward to a liver transplant so she can spend time with her four grandchildren and meet the fifth, who is on the way. 

In the system’s current state, too many people are still unnecessarily dying. As I previously testified before Congress, an efficient and accountable system can provide enough organs for every person removed from a heart, liver or lung transplant waiting list because they died or became too sick for a transplant. Such a system will dramatically decrease the time on the waiting list for a kidney transplant, eliminating suffering and saving lives. Essential and urgent reforms fit into three categories.  

Category 1: Structural Reform and Oversight of the OPTN - The structure of the relationship between the government and the OPTN contractors must fundamentally change.  In the past, the contractors wielded complete control over the system, with disastrous consequences. The Committee is well aware of allegations of OPTN’s failure to ensure organ procurement organizations protect donor patients and recover sufficient organs for those in need. Insufficient oversight of out-of-sequence allocation allowed skipping of patients waiting for life-saving organs, and errors in lung allocation meant that the sickest patients were incorrectly bypassed

Category 2: Standardizing Policy, Supporting Innovation, and Engaging Experts -  There is a need to standardize best practices, promote innovation, and bring in external experts across the transplant system. Technological advances have vastly increased the number of successful donations using this method and saved thousands of lives. Unfortunately, the lack of standardization for how these organs are recovered has led to confusion both for transplant professionals and the public.  HRSA should exert greater control over standardizing the approach to these patients, ensuring clear, sensible policy is enacted, disseminating the rules, and ensuring transplant professionals are appropriately educated. 

The need to promote innovation is similarly urgent. 

Category 3:  Donation Data Availability and OPO Accountability System - HHS must ensure that data for all steps in the donation process, including whether potential donors are correctly referred by a hospital to an OPO, the response of the OPO, how the patient and family are approached, the results of the discussion and the placement of organs, are recorded for study. HRSA’s proposed initiative for data collection regarding patients referred to OPOs for evaluation is a novel and ground-breaking approach for two reasons.  The first is that this desperately needed data will now be collected, and the second is that the data will be directly accessible. It is my hope that HHS will continue to make critical data directly available without constraints

In summary, I have three recommendations: 

1) HHS must restructure the relationship between the government and the contractors operating the nation’s transplant system. HHS should directly collect fees, create a mechanism to receive system complaints outside of the contractor, and directly address egregious patient safety violations by decertifying organizations. HHS must own transplant data and make it broadly available to identify failures and needed solutions that can save lives.  HHS must own the technology required to run the transplant system.    

2) HRSA should be more involved in directing policy.  HRSA must require standardization of policies and procedures, for example, for DCD and technology implementation, and be able to consult and engage experts in each of the fields that impact our transplant system to rapidly maximize the number of donors.  New contracts must be bid out competitively and fairly, and the government must retain the ability to hold contractors accountable and quickly replace contractors who fail to serve the public or interfere with government oversight. 

3) HHS must mandate data reporting for all aspects of the donation process. OPO performance must be measured and performance standards enforced through the OPO Final Rule.  Poorly performing OPOs should be decertified.  The research pancreas loophole must be closed.   On behalf of our patients, I urge Congress and the Administration to implement these reforms as quickly as possible. Because as I testified in 2021, and as transplant candidate Jill Chance understands, time matters in transplantation.

Read the full, unedited testimony here.

Seth J. Karp, M.D. is a Professor of Surgery, Biomedical Ethics & Society, and Anesthesiology at Vanderbilt University.

_{*The opinions expressed in this column are those of the author and do not necessarily reflect the views of HealthPlatform.News.}