Federal rule would create new roles in the search for organ donations
Authority would shift to procurement agencies
A proposed federal rule that would shift control of the organ donation process from hospitals to organ procurement organizations (OPO) will add new demands on critical care operations, but it might also provide some relief, experts say.
Changes proposed in Medicare’s rules governing conditions of participation would raise organ transplantation to a higher priority by mandating closer cooperation between hospitals and OPOs.
This rule change should result in OPOs exercising more authority in determining organ donation policies than individual hospitals, says Phyllis Weber, executive director of the California Transplant Donor Network in San Francisco.
The changes, which are advocated by Vice President Al Gore, would shift much of the authority and responsibilities for organ procurement out of hospitals, a move that might lessen the burden of some health care professionals, says Weber, a board member of the Richmond, VA-based United Network for Organ Sharing. The final rule has not been written, but Weber says it will likely include the following:
• All deaths that occur in hospitals will be reported to that hospital’s OPO.
"National statistics indicate that about a third of patients who could be potential organ donors are not referred to an organ donation organization," Weber notes.
• Hospitals must notify OPOs of potential donors through brain death before death occurs.
That simply means that hospitals would have to notify their OPO as early as possible, Weber says. The hope of supporters is that added lead time will increase transplantation.
Weber also notes that advance notice would give OPO staff time to review the medical histories of potential donors. That would help identify the best candidates and spare the need to approach the families of patients who are not suitable.
• An OPO staff member will be involved in discussions with the family of potential donors.
"The data strongly indicate that when hospital staff talk to a family about an organ donation, the consent rates are dismal, about 15%," says Weber. "But when an organ donation organization makes the contact, the consent rate is more like 60%."
While not criticizing hospitals for their organ procurement efforts, Weber says there have been problems. One is that except for larger institutions most hospitals do not have a lot of experience dealing with the issue. "That means there’s not a lot of organizational memory about how best to proceed," says Weber.
She also notes that although hospitals are generally supportive of organ donation efforts, they simply don’t know how best to go about it. "An example is a person who comes into the emergency room with a head injury and the first thing the family is told is, Gee, things don’t look very good. Maybe you’d better start thinking about organ donation.’ Then the patient may be transferred from emergency to the critical care unit and told again, Gee, things don’t look very good. Maybe you’d better start thinking about an organ donation.’ At that point, the family may start wondering what the hospital’s intent is." (For a case study of how one medical center helps families and increases organ donations, see story, p. 14.)
"If hospitals adopted optimal organ donation practices, an additional 5,000 donors would result, bringing the effectiveness of the donation system from one-third to nearly 70%," says Michael Evanisko, president of the Partnership for Organ Donation in Boston, a nonprofit organization that works with a consortium of medical centers and organ procurement groups to increase organ donation.
Hospitals traditionally have been reluctant to deal with family grief, approaching bereavement as a subject better left untouched. As such, organ donation is seldom or inappropriately raised. "We cannot blame families for not consenting to donation when at least half of the solution to the organ donor shortage can be found by focusing on hospital practices," says Evanisko.
A system that has been found to work best with families, Weber says, is a team effort in which an OPO staff member and a hospital employee approach the family together.
Even though the new rule would shift the organ donation balance of power into the hands of the OPOs, hospitals that want to retain that authority will probably have that option by undergoing training from its OPO, she says.
The proposed new rule is part of a two-pronged federal effort to reduce the growing number of patients waiting for organ transplants. Partnerships also are being sought in the public and private sectors to increase awareness of the need for organ donations.
Current estimates are that 58,000 people are awaiting transplants, and most will not receive them. Studies indicate that there are between 10,000 and 12,000 medically suitable donors each year, with one-third of them never being identified, one-third refusing, and one-third consenting to donations.
The U.S. Department of Health and Human Services will receive comments on the proposed rule changes through Feb. 17. After that, a final rule will be drawn up based on the comments of OPOs, hospitals, tissue banks, physicians, and patient groups. After the final rules are adopted, the Joint Commission on Accreditation of Healthcare Organizations is expected to incorporate those principles into its requirements.
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