Ex-eye bank workers say pressure, lax oversight led to errors

KFF Health NewsNov 20 2024

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 windshield of the eye

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.

Balancing mission and stress

Several of the former employees were hesitant to speak about the Rocky Mountain Lions Eye Bank because they didn't want to sully the reputation of an industry they believe is essential for improving people's lives and honoring the wishes of the dead.

But they described a high-pressure environment that they said led to many of their colleagues leaving and errors that reduced the number of successful retrievals.

Mackenzie Urban started recovering corneas as a technician for the eye bank in 2019 after finishing her bachelor’s degree. She saw it as a temporary job as she applied for medical school. But within a year of recovering her first cornea, she said, enough employees had left that she became the senior recovery technician and was training others.

She used limes for the training, guiding her students on how to use a scalpel to remove the peel without nicking the fruit beneath. Success meant lifting the peel off the lime without any juice spilling out.

"If you're stressed, you're going to shake," Urban said.

Outside factors can compound the challenges of performing the delicate procedure. Maybe the coroner had drawn fluid from beneath the cornea, making collection much trickier, she said. After a person has been dead for about 24 hours, the eyes tend to deflate to the point of uselessness, adding time pressure to collecting donations, Urban said.

Sometimes, Urban said, another technician would be working on a body simultaneously, so that the entire body was moving around while she was trying to do the delicate procedure.

Interactions with grieving families could be intense, too. Sometimes, families would hug her, thankful that something good would come of their loss. Other times, they were hostile, such as the time one relative of a potential donor told her to "Cut your own f****** eyes out, you b****," she recalled.

Urban appreciates the work the eye bank performs and doesn't regret her time there. She said she respected that "they had a real commitment to serving the community and keeping prices low." (It’s illegal to sell human body parts for transplant, but companies get reimbursed varying amounts for the expenses of harvesting, preparing, and shipping tissues.)

But the workplace culture made it untenable for her, she said. For example, Urban said, she was reprimanded and told that she needed to "buck up or get out" because she declined to harvest corneas from a person who died from an unknown cause. The body was purple from the neck down, covered in oozing blisters and with opaque flecks in the eyes, Urban said.

When Irish eyes are smiling

The Rocky Mountain Lions Eye Bank has international contracts and ships corneas to Japan and the U.K., among other destinations. It became the exclusive eye tissue provider for Ireland when that country stopped collecting corneas over fears of transmitting mad cow disease. That means anyone who has received a cornea transplant in Ireland in the past two decades likely now sees thanks to a person who died in Colorado or Wyoming, according to the Irish Blood Transfusion Service.

Lohmeier, the eye bank CEO, said local needs are prioritized for donations, while international shipments help fulfill the eye bank's mission and "ensure that all viable corneas are transplanted, giving the gift of restored sight."

The U.S. is one of the few nations with a cornea surplus. FDA inspection reports confirmed that the Rocky Mountain Lions Eye Bank procures more tissue than its geographic area can use.

The demand for international orders contributed to the high-pressure environment, Lopez said.

Employee turnover and the stress of the job resulted in the collection of corneas of poor quality, Lewis said. Local hospitals inquired about why so many corneas weren't being transplanted, she added.

The leading reason was recovery errors that damaged the tissue, Lewis said.

Lohmeier disagreed that there was a significant decline in corneas being placed. "We do not believe this description accurately reflects the state of corneal recovery and transplants," he said.

Internal records showed that about half of recovered corneas in November 2022 had moderate to heavy stress. The Eye Bank Association of America does not have comparable national data. The closest figure it tracks is the proportion, among tissues that were prepared but not transplanted, that were unable to be transplanted because of damage during processing; in 2022, it was a quarter.

Ashi Moore, who used to lead the Rocky Mountain Lions Eye Bank's quality assurance department, said she once filed a report to the FDA after a donor's eye tissues were removed despite a family history indicating a high risk of Creutzfeldt-Jakob disease. The disease, which should have been disqualifying for donation purposes, is a fatal brain disorder that can be transmitted through infected tissue.

The issue was caught before the corneas could be placed in someone else's eyes, but it should never have gotten to the point that the corneas were removed from the body, Moore said.

At least once, a technician retrieved corneas from the wrong body, according to Moore and other former employees (The FDA was unable to provide records to confirm that report by publication). Moore said she should have been told about the case of mistaken identity immediately but said she wasn't made aware of it until after the eye bank's leaders handled the situation themselves.

She said she couldn't find evidence that the eye bank had reported the error to the FDA. It was one of the major reasons she decided to leave the organization, though she had derived a strong sense of purpose from working at the eye bank, she said.

When Lewis resigned, officials at the nonprofit eye bank offered her $5,000 to sign a severance agreement with a nondisparagement provision. She declined.

Lewis said she would like to see states hold tissue recovery agencies to the same standards as other organizations that handle corpses, such as hospitals, coroners, and funeral homes. And if they fail to meet those standards, they need to be held accountable to build public trust, she said.

Lewis' and Lopez's negative experiences with the eye bank had another consequence. Each decided they no longer wanted to be an organ or tissue donor.

"After witnessing and experiencing so many issues, I no longer feel comfortable with the potential of my family having to go through that when the time comes," Lewis said.

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