A recent front-page story in the Arkansas Democrat-Gazette concerns new rules for organ procuring organizations (OPOs) finalized recently by the Centers for Medicaid and Medicare Services (CMS).
A casual reader who is not well informed about the intricacy of the organ donation and transplant world might conclude from reading it that our local organ procurement agency ARORA was performing in a poor and sub-standard way. Nothing could be further from the truth.
The new rule greatly simplifies the elaborate performance standards that have been in place since 2006 for evaluating performance of an OPO like ARORA. It would use the aggregate number of hospital deaths (per 100,000), reduced by the number of deceased patients whose disease or age (over 75) would obviously rule them out.
The number of deceased that should be "rule outs" will be determined by a review of the cause of death (COD) as documented on the death certificate by a physician. For example, the organ procurement organization gets 30,000 hospital deaths reported to it per year, and the COD indicates that 25,000 had diseases like cancer or some kind of infection, or were too old, thus preventing the organs from being transplanted.
So in theory that leaves maybe 5,000 potential organ donors. There are at least 100,000 on the transplant waiting list. If this potential can be better utilized, everyone gets their organ, right? The new rule is attempting to prove that there is tremendous untapped potential for organ transplants and that OPOs are generally under-performing nationwide.
I served as executive director of ARORA for 14 years. Every Monday, I would sit in clinical meetings while our medical director and staff painstakingly reviewed each and every organ donor referral, doing after-action reviews to determine what, if anything, could have been done in each case to maximize the organs procured for transplants.
About 99 percent of all hospital deaths were being referred to us, and we verified this by comparing hospital death records to the referrals phoned in to our call center. In our best years we were able to recover organs and get them accepted by a transplant center about 80 times.
Why so low?
First, the premise of using hospital deaths to determine organ donor potential is an old and discredited performance standard. In fact, a federal judge in Little Rock declared these same types of certification standards "arbitrary and capricious" in July 2000.
This ruling forced CMS to rewrite the standards for OPO certification; the task was so complex it took them six years. We went through two certification audits while I was at ARORA and found these new performance standards to be thorough and appropriately demanding.
The number of hospital deaths has absolutely no relationship to organ donor potential. In order to be a viable organ donor the deceased patient has to be:
- Brain-dead and on a ventilator with the heart still beating and a high enough blood pressure to maintain functioning organs, or
- On a ventilator, taken off the ventilator, declared dead by an attending physician upon cardiac arrest, and have a transplant team standing by for immediate recovery of organs. These circumstances occur in only about one percent of hospital deaths. If a patient dies and there is no ventilator to keep the heart beating, there is zero chance for organ recovery.
The new rule relies heavily on death certificates to determine donor potential. Our experience is that the death certificates often merely state "cardiac arrest" as the cause of death. There may be no mention of actual factors like cancer, staph infection, stroke, or multi-system organ failure that led to cardiac arrest. Death certificates are useless in determining whether a deceased patient had organ donor potential.
Besides, it is not possible to get a year's worth of death certificates to review until about 18 months after that particular calendar year has ended.
The organ procurement system and transplant programs are two separate parts of organ donation. The Organ Procurement Transplant Network (OPTN) managed by the United Network for Organ Sharing (UNOS) governs the overall system for organ donation in the U.S.
There are 58 OPOs and hundreds of transplant programs in the nation. Each transplant program maintains a list of people who have qualified for an organ transplant. The OPOs must communicate and coordinate closely with transplant programs to ensure a successful recovery and transplant.
The entire process of obtaining consent for donation, managing the brain-dead patient, obtaining lab results, contacting each transplant program with a match for the deceased, and bringing in the transplant team for recovery may take three or even four days.
Sometimes, after 48 hours of continuous work and exhausting the national wait lists, an organ or organs may not be accepted due to marginal lab numbers or medical history. This system is challenging and never simple.
H.L. Mencken said, "Every complex problem has a solution that is simple, direct, and wrong." This sums up the new CMS final rule. The only accurate way to evaluate an OPO's organ donor performance is to determine the number of ventilated deceased patients referred and eliminate those who should be ruled out due to age and disease factors or medical history.
Then, from that much smaller number, look at the percentage of consented donors and the percentage of donors with organs recovered and transplanted.
I cannot speak to the recent performance data of ARORA since I have not been involved in its operations since I retired in 2014. However, during my time there ARORA doubled the number of donors from 2000-2014 and improved the rate of successful transplants from below 50 percent to 80 percent.
ARORA was consistently being ranked in the 75th percentile when compared to its 57 OPO peers at the time I left. Every single organ was aggressively worked for a successful transplant, even if the final outcome was only a one-organ donor.
This new "final rule" implemented by CMS may cause ARORA to be decertified if left in place. When that happens, a much larger OPO will get the opportunity to take over its territory. And people in places like Kansas City or St. Louis or Dallas will be in charge of providing organs to our local transplant programs at UAMS and Children's Hospital.
Those other big-city transplant programs have much larger waiting lists. I would hate to see this affect the placement of organs at our local transplant programs.
Boyd Ward is the former executive director of the Arkansas Regional Organ Recovery Agency Agency, now retired.