This story by By Madelyn Beck (WyoFile) and Rae Ellen Bichell was originally co-published by KFF Health News and WyoFile on November 20, 2024.. We are sharing it in two parts.
William Lopez remembers clearly the day in June 2017 when he says he was asked to call the spouse of a college friend who had just died and ask for her eyes.
The spouse hadn’t responded to calls from other employees at the Rocky Mountain Lions Eye Bank, he said. As Lopez recalled, his supervisor thought a friend’s personal number would have more success.
Lopez refused. “I went for a walk,” he said.
Even without Lopez’s help, the eye bank that procures corneas from deceased donors in Wyoming and Colorado eventually collected his friend’s corneas, Lopez said.
Lopez, who had entered the field to help people, became increasingly disillusioned during his three years working with the eye bank, despite rising from a technician to the distribution manager, and ultimately quit.
Checking the “donor” box on a driver’s license application, people may picture their heart, kidneys, or other organs saving another person’s life should the worst happen.
They are less likely to consider that tissues — corneas, tendons, bone marrow, skin, bone — are also covered by that checked box. In fact, donated tissues are collected much more frequently than organs, and corneas are the most commonly transplanted body part in the U.S., with nearly 51,000 transplants last year, according to the Eye Bank Association of America.
Organ and tissue donations are guided by different rules, with less transparency and what critics identify as more self-policing in the tissue donation industry. In Wyoming and Colorado, where the Rocky Mountain Lions Eye Bank estimates it collects eye tissue from about 2,500 deceased donors a year, that has contributed to a tense work environment resulting in damaged or wasted tissues due to accidents, four former eye bank employees say.
“I think there’s an urgent need for stricter oversight of the donation process in general, particularly for eye and tissue banks,” said Janell Lewis, who worked at the Rocky Mountain Lions Eye Bank for 12 years, managing public relations and overseeing fundraising before she quit in February 2023.
John Lohmeier, executive director of the Rocky Mountain Lions Eye Bank, declined to be interviewed for this article. In a prepared statement, he said he couldn’t comment on personnel matters or specific incidents raised by the former employees.
But generally, he wrote, “there are internal procedures that have been in place and continue to be followed to investigate and/or report any incident that would impact health and safety concerns.”
Lewis, Lopez, and two other former eye bank employees recalled one or more of the following problems during their time at Rocky Mountain Lions Eye Bank:
Removal of eye tissue from the wrong body
Damage or destruction of corneas due to improper removal
Removal of corneas from a donor with a high-risk family history that could endanger a transplant recipient
Lack of transparency about whether errors were being reported to federal agencies
Pressuring and bullying of technicians
High turnover and brief training of low-paid and inexperienced technicians
The cornea is considered the windshield of the eye. It is a clear dome that protects the eye from contaminants, maintains fluid balance, and filters light. Recipients of cornea donations typically need transplants because of trauma, infection, or other conditions that cause blindness or blurred or cloudy vision.
The Rocky Mountain Lions Eye Bank is one of about 60 eye banks operating in the U.S., which leads the world in corneal transplants. New technicians often arrive at the eye bank untrained, sometimes with only a high school diploma, to perform the grim job of removing corneas from recently deceased corpses for about the same wages many fast-food workers earn.
But what eye bank technicians may lack in education and training, they generally make up for with a strong belief in the mission, according to the former employees. They said they joined the Rocky Mountain Lions Eye Bank because they wanted to help restore people’s sight.
The nonprofit employs about 70 people across Colorado and Wyoming, according to a tax filing submitted in 2023. Those records also show a net income of less than $1 million and more than $16 million in assets. Lohmeier was paid about $142,000.
Organs vs. tissue
Organ donations fall under the purview of the Health Resources and Services Administration, and public data details performance and financial transaction records of organ procurement groups. Tissue donation is regulated by the Food and Drug Administration, as well as national industry groups, and tissue bank transactions, performance, and outcomes are not available to the public.
There’s no reason tissues and organs should be treated differently, said Robert Dickson, medical director for the Washtenaw County Tuberculosis Clinic in Michigan. A patient in his county died from a bone graft contaminated with tuberculosis just a couple of years after a contaminated bone graft killed eight other patients.
He compared the tissue regulatory environment to the Wild West and called it a major public health concern.
“It’s fundamentally no different from an organ transplant. You’re taking tissue from one deceased patient and putting it into a living recipient. But it is not regulated and not tested as rigorously,” he said.
Marc Pearce, president and CEO of the American Association of Tissue Banks, said such cases are very rare.
“We don’t believe that we’ve proven ourselves to be not capable of regulating ourselves,” he said.
FDA officials disagree that the tissue industry is largely self-regulated, pointing to federal rules that require certain organizations to register with the agency and provide a list of human cells or tissues they recover, store, or distribute.
The rules set donor eligibility requirements, and the agency inspects tissue establishments, including eye banks, said spokesperson Carly Pflaum.
“The FDA has implemented a tiered risk-based approach for the regulation of human cell, tissue and cellular and tissue-based products,” Pflaum wrote.
KFF Health News and WyoFile months ago requested reports of adverse events associated with the Rocky Mountain Lions Eye Bank, but the FDA has yet to provide them. FDA dashboards show the eye bank has not issued a recall since 2017, and inspections since at least 2009 have not resulted in any official action.
The tissue industry is largely self-monitored and the performance of eye banks is tracked internally, whereas the federal government publishes annual performance reports for organ procurement groups. Health care providers are not required to report to the FDA adverse events resulting from tissue transplants.
Organ transplant providers are required to report safety events in recipients within 72 hours to the Organ Procurement and Transplantation Network, which operates under contract with the U.S. Department of Health and Human Services. That includes an organ going unused because it was delivered to the wrong location. They have 24 hours if, for example, the recipient gets an infection or disease that may have been from the new organ.
Other countries have public registries detailing the outcomes of corneal transplants, including Australia, the United Kingdom, and Sweden. A similar registry in the U.S. could help monitor outcomes for patients and identify adverse events from transplant procedures, eye doctors and researchers wrote in the journal Ophthalmology Science.
Tissue bank industry groups are responsible for much of the oversight of their dues-paying members. Transplanting surgeons may report adverse reactions to the tissue bank, which generally then conducts a review and submits a report to the FDA and the Eye Bank Association of America or the American Association of Tissue Banks.
Nearly all eye banks in the U.S. are members of the Eye Bank Association of America, which inspects member banks at least every three years as part of its accreditation process, but such inspection reports aren’t publicly available. Safety is paramount, association president Kevin Corcoran said, and the association’s medical standards require eye banks to request patient outcome information from transplanting surgeons a few months after surgery.
“We want to make sure we don’t have an eye bank that is slipping in their performance or failing to recover tissue,” he said. He declined to comment on any individual eye bank’s performance or release quality or transplantation data, complaints filed, or investigations undertaken.
No investigations have resulted in corrective action, he said, in the 13 years he has been at the association. The Rocky Mountain Lions Eye Bank is an accredited member of the association.
Read Part Two, on Friday…