Resource Newsletter Archive
Two OIG Reports Released; Recommendations Made
Northwest Tissue Services's director, Margery Moogk.
In January, the Office of the Inspector General (OIG) released two reports, “Informed Consent in Tissue Donation” and “Oversight of Tissue Banking” (reports available at http://oig.hhs.gov/oei). The inquiry, requested by the secretary of Health and Human Services, followed a series of media exposés that raised concerns about tissue banking practices.
As a result of the Northwest Tissue Services's participation in the process, we initiated several changes even before the reports were issued. To promote a higher level of consciousness among involved medical professionals and transplant recipients about the source of tissue and the contribution of donor families, all new tissue labels read “Donated human tissue.”
We also reviewed our consent practices and made two changes to further insure that families are being given enough information. Previously, we provided a copy of the consent form to the family, if they requested it. Now we send a copy to every family. Additionally, we have modified the consent process in the three regional hospitals where hearts donated for valves for transplant are recovered and processed by Cryolife. We have retrained those who seek consent to inform families that it is hospital policy for hearts to go to the for-profit company and to document that the information was provided. Our experience indicates that this information is important to many families considering donation.
Practices clash with expectations The report on informed consent found that families who donate do so out of altruistic motives and expectations that the tissue will be used to meet important medical needs, the donor's body will be respected, the gift will be recognized as coming from donated tissue, and the organizations that recover and utilize the donation will act as stewards of the gift.
The OIG determined that some of the realities of tissue banking in this new, highly competitive environment clash with families' assumptions. Uncovering evidence of commercialization, commodification, and cosmetic uses of tissue led the OIG report to ask, “If a company's primary interest is financial benefit to its stockholders, is it choosing to put tissue to more lucrative uses over medical needs?” It concludes that changes that may not apply to other businesses are necessary in tissue banking.
Disclosure, training, accountability needed The report makes recommendations based on the principles of “enhancing equity for patients, improving access to transplantation, and encouraging donation.” It encourages HRSA to develop guidelines for consent requests, suggest content for information to share with families and for consent requestors, and recommend assessment tools for evaluating requestors' effectiveness. It says HCFA should consider holding OPOs accountable for assuring informed consent for tissue donation from organ donors and requiring OPOs to include tissue banks in training for consent requestors. Neither of these last two suggestions have implications in this region where current practices already apply them.
Ensuring faithful stewardship Suggestions for tissue banks include providing written materials that more fully disclose tissue uses, the involvement of processing and distributing entities and how to get more information. The tissue label and accompanying materials should indicate “donated human tissue.” All who request consent for tissue donation should be trained, updated, and assessed to ensure complete information is provided to families.
The report also encourages tissue banks and donor family groups to determine what financial information about tissue banking would be useful for families considering donation, the impact of disclosure on donation, and whether it should be provided only upon a family's request or in all cases.
The second report on oversight of tissue banking recommends that the FDA should expedite tissue bank registration and the implementation of additional regulations governing donor suitability and good tissue practices. (Anticipating these suggestions, the FDA had already published final rule requiring tissue banks to register and submit product lists by May 4. They also published the third set of proposed rules defining current good tissue practices.) The OIG encouraged setting a date by which all tissue banks will have been inspected, a minimum cycle for tissue bank inspection, and cooperation between FDA, states, and professional organizations that have inspection programs.
The Tissue Services appreciated the opportunity to discuss these important issues with the team of investigators from the OIG; the reports reflect many of the concerns we expressed. We continue to promote community involvement in tissue banking as implemented here in the Northwest to assure fair and equitable access to transplant tissue for all patients and to guarantee that medical needs are met first. As we evaluate opportunities for partnering with other organizations to offer innovative, tissue-based products, we will continue to be faithful stewards for those who donate.