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U. S. NUCLEAR REGULATORY COMMISSION

OFFICE OF PUBLIC AFFAIRS, REGION II

61 Forsyth Street, Suite 23T85, Atlanta, GA 30303

CONTACT: Ken Clark (Phone: 404/562-4416, E-mail: kmc2@nrc.gov )
Roger Hannah (Phone 404/562-4417, E-mail: rdh1@nrc.gov )

No: II-98-15

February 24, 1998

NRC STAFF TO DISCUSS APPARENT VIOLATIONS WITH

PHYSICIAN AND HOSPITAL IN PUERTO RICO ON MARCH 2

The Nuclear Regulatory Commission staff has scheduled two predecisional enforcement conferences, one with José N. De León, M.D. and the other with Ryder Memorial Hospital, to discuss apparent violations related to the use of radioactive material (strontium-90) in an eye applicator.

NRC inspections at the hospital in Humacao and at Dr. De León's office in Isla Verde found that from 1994 to 1996 some patients were given the wrong doses of radiation during treatment.

The NRC has identified two apparent violations for Ryder Memorial Hospital -- (1) failure to establish and implement a Quality Management Program for the use of strontium-90 in ophthalmic brachytherapy between July 1994 and February 1996; and (2) failure to include an authorized user on the radiation safety committee membership. Dr. De León is being asked to respond to one apparent violation -- the failure to establish and maintain Quality Management Program procedures for the use of strontium-90 in ophthalmic brachytherapy between July 1994 and June 1996.

The meetings will be held at the Hampton Inn, 6530 Isla Verde Road, Carolina, Puerto Rico. The enforcement conference for Dr. De León begins at 9:00 a.m. and the conference for Ryder Memorial Hospital begins at 10:30 a.m. The meetings are open to observation by the public and the media, and NRC officials will be available at their conclusion to answer questions from interested observers.

NRC officials said the decision to hold a predecisional enforcement conference does not mean that a determination has been made that a violation has occurred or that enforcement action will be taken. The purpose of the conferences is to discuss apparent violations, their causes and safety significance; to provide the licensee an opportunity to point out any errors that may have been made in the NRC inspection report; and to enable the licensee to outline proposed corrective actions.

No decision on the apparent violations or any contemplated enforcement action, such as a civil penalty, will be made at these conferences. Those decisions will be made later by senior NRC officials.