A now-closed Raleigh company's practice of collecting human tissue from area funeral parlors surprised many North Carolina funeral homes and the state board that regulates them.
"This appears to be a new phenomenon in North Carolina," said Paul Harris, executive director of the N.C. Board of Funeral Service, which licenses and regulates 742 funeral homes and 75 crematoriums.
The U.S. Food and Drug Administration said Donor Referral Services endangered public health by failing to appropriately screen and label tissue collected for transplantation.
Timmy Butler, a Sampson County funeral home director and president of a statewide group that represents about 400 funeral directors and morticians, said he has never heard of homes allowing organ or tissue donations to be extracted on site. There are no laws prohibiting it. Still, Butler was confounded by news reports that described how a Raleigh crematorium invited tissue collectors from the shuttered company into its facility.
"I thought, 'They're doing what?'" said Butler, president of the Funeral Directors and Morticians Association of North Carolina. "My first instinct is that that kind of thing should be taken care of in a medical facility."
Harris said he had heard of Donor Referral Services but did not know exactly what the company did. Last year, though, Harris authorized funeral directors to receive continuing education credit for attending a seminar the company participated in to help drum up business.
In ordering Donor Referral Services to close, the FDA said, among other things, that the company had listed some donors as younger than they actually were and failed to identify one donor as a user of intravenous drugs. Strict tissue-donor criteria followed by most organ and tissue agencies would exclude such a person because of the risk of spreading diseases such as HIV/AIDS.
There is a vast and lucrative market for organs and other body parts, as well as whole bodies. Under a 1968 federal law, relatives of donors cannot collect money for a body or tissue donation, but organ and tissue procurement services and distributors may recover the costs of extracting, processing and distribution. A Raleigh crematorium, Cremation Society of the Carolinas, was paid up to $1,000 for each of the roughly 60 donors it sent to Donor Referral Services, according to the funeral home's president, Larry Parker.
Organs and body parts such as bone, skin and other tissue are needed for all types of transplants and medical procedures. Demand perennially outstrips supply, especially for organs. And medical researchers require body parts for study purposes and entire cadavers that help students learn anatomy. There is even a commercial market for bodies that can be used in vehicle crash tests.
The FDA oversees organs and tissue processed for transplants, but the rest of the industry is largely unregulated.
Harris said the funeral services board has not established rules or guidelines to govern how funeral homes may allow the collection of donated organs, tissue or whole bodies in their facilities.
"I can foresee that there may be some coming," he said.
Any rules would apply only to funeral homes. Companies such as Donor Referral Services fall outside the board's jurisdiction.
Noelle Granger, a professor of medicine at UNC-Chapel Hill and chairwoman of a commission that oversees whole-body donations to medical schools, plans to recommend that the N.C. Commission on Anatomy begin regulating such agencies when its members meet next month.
"These companies fly under the radar," Granger said of businesses such as Donor Referral Services.
She said she had followed reports about problems with the trade of body parts in other states, including a New Jersey scheme where body parts were harvested without family consent, uncovered this year, but had not heard of any in North Carolina.
Most in the funeral industry said they have an arm's-length relationship with organ and tissue procurement agencies. Body parts are collected in sterile operating rooms, not in funeral homes. And it's typically a nonprofit agency designated by the federal government as a high-quality service, not a for-profit company, doing the harvesting, or "recovery" as it's known in the organ and tissue world.
There are just two such federally designated agencies in North Carolina: Carolina Donor Services in Durham, which serves the Triangle and most of the state and LifeShare of the Carolinas, which serves Charlotte and the southwestern part of the state. Under state law, those agencies are notified of all deaths in North Carolina hospitals so families can be contacted about organ and tissue donation.
Carolina Donor Services, which recovers organs and tissue from between 350 and 400 donors a year, does not pay a referral fee to any facility that puts it in contact with donor families, said Jeannine Sato, the nonprofit's director of communications. Carolina Donor Services supplies tissue to accredited tissue banks that reimburse the agency for its services, she said.
Parker, the Raleigh crematorium president, said there is nothing improper in a funeral home accepting reimbursement for its role in procuring tissue. Homes must store bodies, help obtain family consent and arrange for timely collection of specimens, he said.
"You have to train staff, you've got to develop forms," Parker said. "You can't run this on nothing."