Tissue banks may get rules

Proposal follows shutdown of business

A state House committee, reacting to the federal shutdown last year of a Raleigh human tissue procurer, is preparing to propose basic rules for tissue banks.

The proposal would require banks that collect tissue outside hospitals that is intended for transplant be accredited by one of two trade associations unless they have a special federal designation.

Funeral homes could allow only those companies accredited by the American Association of Tissue Banks or the Eye Bank Association of America, or that have the federal designation, to collect tissue from bodies they control.

A House committee discussing health care took on tissue banks as one of its issues in response to the federal shutdown in August of a Raleigh business, Donor Referral Services, that collected human tissue.

The U.S. Food and Drug Administration said the company had misstated the age, cause of death and other risk factors for at least five donors.

To operate legally, Donor Referral Services had only to register with the FDA.

Rep. Lucy Allen, a Louisburg Democrat who helped develop the proposal, said the state should have more safeguards. According to the FDA, 45 tissue banks operate in the state.

"It puts a safety valve in there we had not had before," she said.

The legislature will begin meeting Jan. 24 to consider new laws.

Some say legislators should consider taking a greater role in ensuring the safety of transplanted tissues.

"I don't know if it goes far enough," said Harriet Bartnick of Raleigh, a board member for the Funeral Consumers Alliance of the Triangle.

Five states have their own tissue bank licensing system, and two of those, Florida and New York, also inspect the companies.

Bartnick questioned whether North Carolina should make accreditation with trade associations, which have no authority to shut down or fine anyone, the foundation of its law.

She supports setting up a regulatory commission to oversee tissue banks.

The N.C. Commission on Anatomy, which oversees whole-body donations to medical schools, will recommend the state set up such a regulatory board when it meets in the next few months, said Noelle Granger, a professor of medicine at UNC-Chapel Hill and the commission's chairwoman.