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Date: Wednesday, June 17, 1998
FOR IMMEDIATE RELEASE
Contact: HCFA Press Office (202) 690-6145

HHS Secretary Donna E. Shalala today announced new regulations aimed at saving livesby substantially increasing organ donation in the United States.

Under the final rule, U.S. hospitals will be required to notify an organ procurement organization (OPO) of all deaths that occur in the hospital. The new requirement will ensure that OPOs have the opportunity to determine the suitability of every potential organ donor, thus increasing the opportunities to contact families and request organ donation. HHS estimates that the new provisions can increase donation by 20 percent over the next two years.

"Organ donation saves lives. But in too many cases today, we are missing opportunities to save people simply because families are never contacted and donation is never even considered as an option," Secretary Shalala said.

"I want our organ procurement organizations to do a better job of making more organs available to save more lives," she said. "The first step is to assure that OPOs 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 the families."

The regulation, affecting all 5,200 short-stay hospitals in the country, becomes a condition for participation in the Medicare program. The new final rule is the latest step in the National Organ and Tissue Donation Initiative, launched by Vice President Gore last December.

An estimated 12,000 to 15,000 deaths each year could result in organ donation. However, in 1997 only 5,475 deaths resulted in donation. One 1996 study indicated that, out of all deaths that could result in donation, families agreed to donation in 32 percent of cases, and families denied consent in 37 percent of cases. But in 27 percent of cases, representing some 3,000 to 4,000 deaths, either potential donors were not identified or no request was made to the family. (Another 5 percent ultimately proved medically unsuitable.)

At the same time, the number of Americans who die each year waiting for an organ transplant is about 4,000.

"In the absence of the requirement we are making today, we have been missing thousands of opportunities for donation each year," Secretary Shalala said. "With better identification of potential donors, we can substantially reduce the number of deaths among those awaiting a transplant."

Under the rule, hospitals will refer 2.1 million hospital deaths annually to the nation's 63 OPOs or to a third party designated by the OPOs to handle the referrals. Hospitals also will work with the OPO to ensure that the family of every potential donor knows about its option to donate organs or tissues. Hospitals will also have agreements with at least one tissue bank and one eye bank to preserve and distribute tissues and eyes, as long as these agreements do not interfere with organ donation.

"By requiring hospitals to report all deaths and imminent deaths to OPOs, we hope to increase the supply of organs and thus reduce the number of people on waiting lists for organ transplants." said Nancy-Ann DeParle, administrator of the Health Care Financing Administration, the HHS agency that oversees Medicare. OPOs in states that have passed similar laws have seen an increase of up to 40 percent in organ donation.

Consent for organ donation is requested even in cases where the individual has signed an organ donor card. The card provides an indication of the individual's wish, but consent by survivors is still needed. "That's why it's so important to not only sign the organ donor card, but also to tell your family your wishes," Secretary Shalala said.

In working directly with families, hospitals and OPOs must demonstrate discretion and sensitivity with respect to the circumstances, views and beliefs of the families of potential donors. To this end, hospitals must select an OPO representative, or others who have completed a training course offered or approved by the OPO. Hospitals also must work with OPOs and the eye and tissue banks to educate hospital staff on donation issues and review death records to make sure potential donors were identified correctly.