NRC SUSPENDS LICENSE OF PENNSYLVANIA MEDICAL FIRM

The Nuclear Regulatory Commission has suspended the license of an Easton, Pa., medical company that provides nuclear medicine services for diagnostic purposes. An Order was issued Friday to Advanced Medical Imaging and Nuclear Services.

The Order directed the company to place all NRC-licensed material into secured storage and to suspend all NRC-licensed activities. The Order also requires that the company maintain all records related to licensed material in their original form and bars the company from ordering, purchasing, receiving or transferring NRC-licensed material.

The NRC's Region I office conducted an initial inspection of the firm's facility at 3729 Easton-Nazareth Highway on November 30. The aim of the inspection was to review activities authorized by an NRC license issued to the company on February 16 of this year. During the inspection, the NRC determined that since at least June, the firm had been conducting activities without an Authorized User (of nuclear materials) or Radiation Safety Officer, as required by its NRC license.

After these violations were found, the NRC issued a confirmatory action letter on December 3, which documented the company's commitment to immediately place all NRC-licensed nuclear materials in its possession in secure storage and cease all licensed activities until it had hired an NRC-approved Authorized User (AU) and Radiation Safety Officer (RSO), which would need NRC approval in the form of a license amendment. In addition, the new RSO would evaluate the company's radiation safety program to ensure it was in full compliance with NRC requirements before resuming use of NRC- licensed material.

On December 11, the NRC issued a license amendment, reflecting a new authorized user and new radiation safety officer. However, the NRC subsequently found that after the issuance of the license amendment, materials were ordered and used by an individual who had not received the required instructions from, and who was not under the supervision of, an authorized user physician, despite the commitments made by the firm in the confirmatory action letter to ensure full compliance with NRC requirements before resuming operations.

In the Order, Carl J. Paperiello, Deputy Executive Director for Materials Research and State Programs, said, "The NRC must be able to rely on the Licensee and its employees to comply with NRC requirements. It is important that licensed material be used by, or under the supervision of, an AU, and that radiation safety aspects of the Licensee's program are being performed in accordance with approved procedures and regulatory requirements, as verified by a RSO. In this regard, it appears that the Licensee has repeatedly failed to comply with NRC requirements, as indicated herein. These actions by the Licensee have raised serious doubt as to whether the Licensee can be relied upon in the future to comply with NRC requirements."

The Order is effective immediately. Advanced Medical Imaging, and anyone adversely affected by the Order, may request a hearing within 20 days of the date of the Order. The company must respond to the Order within 20 days.

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Friday, December 05, 2008