Resource Newsletter Archive
Lessons Best Learned Before Choosing a Tissue Supplier
Tissue Services Director Margery Moogk
How could the illegal activities of Biomedical Tissue Services (BTS), a New Jersey based for-profit tissue procurement program, have gone undetected by tissue processors, the New York Department of Health, and the FDA? What can we learn from the investigations to prevent similar abuses of donor families and transplant recipients in the future?
Last September, a medical director for a tissue processor made a routine call to a primary care physician to clarify a tissue donor’s medical history. He discovered there was no doctor by that name, and it was the beginning of a scandal that has rocked the entire tissue banking and transplant community.
BTS recovered tissue from nearly 1,100 donors and sent it to five tissue processors – Regeneration Technologies, Inc. (RTI), LifeCell Corporation, Tutogen Medical, Inc., Lost Mountain Tissue Bank, and the Blood and Tissue Services of Central Texas. More than 25,000 tissue grafts went to health care providers in all 50 states and many foreign countries.
Instead of seeking consent from donor families and doing medical and social history screening, BTS staff forged the documents. They falsified autopsy records and certificates of death. They reported inaccurate information about cause of death and donor age. And now we know that the sample of blood they tested was not always the donor’s, so the results of blood tests to confirm donor safety are unreliable.
Prosecutors have brought a 122-count indictment against the owners. Hospitals that received tissue from BTS are being notified and the CDC is recommending that patients who received it be tested for hepatitis B and C and HIV. Media coverage has been extensive. Patients are filing lawsuits, and new rules may be coming to govern tissue banking.
We know that some of our regional hospitals have been notified of the recalls. We have reassured physicians and patients who have received tissue from us that Northwest Tissue Services has never had any dealings with BTS or the processors who worked with them.
At AATB, we are reviewing standards and accreditation policies and will be making revisions as a result of our investigations. FDA is contemplating new regulations, and several bills are going before legislatures. But can we be sure any of these changes will guarantee this kind of abuse will never happen again?
Tissue banking has become very competitive. It is no longer a small community of professionals who share the same respect for donor families and feel the same responsibility for patient safety. Some new players underestimate the criticality of the goodwill that leads to donation. They rely too heavily on decontamination and testing and would have us believe practically anyone can donate tissue for transplant.
There is no question that competition has brought many improvements. But as the BTS experience shows, the prospect of financial gain has also led to dangerous shortcuts, disrespectful abuses, and fraud.
Please remember that Northwest Tissue Services is committed to being this region’s resource for transplant tissue and for tissue banking expertise. We can help you evaluate alternative suppliers among those whose programs we respect.
You should know more about your tissue supplier than mere marketing claims and attractive fee schedules.