Feds announce additional organ proposal

Identifying donors shifts to outside organizations

As if the federal government's announcement in late March regarding organ allocation policy revisions weren't confusing enough, a new rule may further complicate the matter.

The rule, announced in June by the Department of Health and Human Services Secretary Donna Shalala, will require hospitals to report every death to local organ procurement organizations. In turn, those organizations will then approach the family and coordinate organ transplants.

The proposed rule cannot go into effect until it receives Congressional approval, however. If passed, the rule would become part of the conditions of participation in the Medicare program. It is the latest step in the National Organ and Tissue Donation Initiative launched last year by Vice President Al Gore.

"There is some confusion over the two policy changes. There is still a lot of controversy surrounding the proposal to change the organ allocation policy. But for the most part, the transplant community supports the proposal to report deaths to organ procurement agencies because that increases the rates of organ donation," says John Rabkin, MD, chief of liver transplantation at Oregon Health Sciences University in Portland. (See Medical Ethics Advisor, April 1998, pp. 37-40.)

The government hopes the rule will increase donations by 20% in two years. One stipulation in the rule requires that people with special training in organ donation approach families to request consent. As a result, the responsibility would no longer fall within the hospital's domain but within the organ procurement organization's domain. (For more information on organ procurement organizations, see related story, p. 88.)

Hospitals will refer more than 2 million deaths annually to the nation's 63 organ procurement organizations. Under the rule, however, organ procurement organizations can designate a third party to handle referrals. Hospitals also must have an agreement with at least one tissue bank and one eye bank to preserve and distribute tissues and eyes.

"I want our organ procurement organizations to do a better job of making more organs available to save more lives," says Shalala. "The first step is to assure that organ procurement organizations are informed of all deaths in hospitals. Then they can determine in each case whether there is the potential for organ donation and, using appropriate discretion and sensitivity, approach the subject of donation with families."

Business as usual for hospitals

While a change in organ allocation is still being wrangled about by lawmakers, the proposal to inform local organ procurement organizations for all deaths would only be an improvement, says Rabkin.

"The emphasis on the government's part is to have more professionals involved in the process. The shift among providers toward improving the donation request process is already occurring. Organ procurement organizations are working with hospitals at training personnel in conducting the donation request process. The proposal just stipulates that the organization should be working closely with the hospital," he adds.

Working with the organ procurement agency is an advantage, Rabkin adds. "Most likely, physicians and nurses in hospitals who are adept at talking with families regarding organ donation are knowledgeable about the current criteria for acceptable organs, for example, and that just demonstrates a good working relationship with the procurement organization."

Equally important in the organ donation process is to have trained staff, Rabkin notes. He points out several studies that demonstrate the effectiveness of decoupling - or removing the organ donation request - from the role of the caregivers. "There needs to be someone in the hospital who is trained on the entire process of talking to the family about organ donation. Research shows that the rates of donation are higher when the patient's physician or nurse is not included, but rather a different professional is involved."

To further complicate the matter, a supplemental appropriations bill passed by Congress in April extends the public comment period on previously announced requirements. The public comment period for policy changes announced in March was extended from June 1 to Aug. 31, 1998 on Organ Procurement and Transplantation Network regulations. The Department of Health and Human Services cannot implement the regulations before Oct. 1, 1998. (See Medical Ethics Advisor, May 1998, p. 49.)

As Medical Ethics Advisor went to press, both the House of Representatives and Senate had bills on the floor delaying the effective date of policy proposals from Health and Human Services regarding the Organ Procurement Transplant Network regulations. A delay in the proposed rule concerning the requirement to report deaths to procurement organizations also is expected.

Rule comes with good intentions

The government says that too many families aren't asked about organ donation when a loved one dies. Government officials estimate that organs could be used from 12,000 to 15,000 people who die each year. There were, however, fewer than 5,500 donors in 1997. Meanwhile, approximately 4,000 patients die each year while waiting for a transplant.

The issue over keeping organs in a local area, however, is creating a backlash among state lawmakers. Four states, for example, have passed laws or in the process of passing laws that require donated organs to stay within the state if there is a viable match with a patient in the state. (For more on legislative actions, see the related story, p. 89.)

The newest proposal is modeled after a 1995 law enacted in Pennsylvania requiring hospitals to report all deaths to organ procurement organizations. As a result, the Delaware Valley Transplant Program in Philadelphia increased its donor rate by 40% over a three-year period. Officials at the Department of Health and Human Services hope that those same results can be replicated across the nation.

Shortage is a definite reality

One certainty, regardless of which side of the debate a person may be on, is the fact that there is a critical shortage of available organs. "The hope is that donations will increase by 20% in two years, says Jeffrey P. Kahn, PhD, MPH, director of the Center for Bioethics at the University of Minnesota in Minneapolis.

"But even a 20% increase will only begin to undent the unmet need for organs. In addition to these changes we need to create new pools of donors."