No. I-08-020 

Contact: Diane Screnci, 610/337-5330 

 Neil Sheehan, 610/337-5331 

April 7, 2008

 

NRC PROPOSES $6,500 CIVIL PENALTY FOR NUCLEAR MEDICINE COMPANY 

FOR VIOLATIONS AT SITES IN NEW JERSEY AND PENNSYLVANIA 

The Nuclear Regulatory Commission (NRC) staff has proposed a $6,500 fine for a 

California-based company for two violations of agency requirements at nuclear medicine 

facilities in New Jersey and Pennsylvania. The violations by Digirad Imaging Solutions (DIS), 

Inc., of Poway, Calif., involve documentation pertaining to a proposed radioactive material 

user’s qualifications and the control and security of radioactive materials. 

Based on an inspection conducted from July 20 to 25, 2007 at DIS base and client sites in 

New Jersey and Pennsylvania, as well as a subsequent investigation performed by the NRC 

Office of Investigations, the NRC identified three apparent violations. (Base sites are locations 

where the company has regular access and can store materials. Client sites are locations where 

the company has access for brief periods of time and no materials are stored there.) The base 

locations were in Allentown, Pa., and Ridley Park, Pa. The client sites were in Egg Harbor 

Township, N.J., and Philadelphia. 

 The NRC staff has proposed the fine for two of three violations identified; enforcement 

discretion is being exercised on a third violation involving the submittal of incomplete and 

inaccurate amendment applications to the NRC requesting additional base site locations. 

The violations being cited are: 

● In April 2006, Digirad asked the NRC for permission to add a doctor to its license 

as an authorized user. Specifically, the firm stated the doctor it wanted to add had trained under 

an approved physician-supervisor for at least 700 hours in 2,000 cases. In fact, the training never 

occurred. Further, the doctor was not qualified to become an authorized user under Digirad’s 

license because the physician who was supposed to have provided the training was himself not 

an authorized user, as required by NRC regulations. 

“The NRC concluded that this inaccurate information could have resulted in an individual 

being added to an NRC license who did not fully meet NRC requirements as an authorized user,” 

NRC Region I Administrator Samuel J. Collins wrote in a letter to the company regarding the 

enforcement action. 

NRC NEWS

U.S. NUCLEAR REGULATORY COMMISSION

Office of Public Affairs, Region I 

475 Allendale Road, King of Prussia, Pa. 19406 

E-mail: opa1@nrc.gov 

Site: http://www.nrc.gov
Mr. Collins said the violation was of “particular concern to the NRC” since the firm was 

cited for the same infraction several years ago and settled that violation through the agency’s 

Alternate Dispute Resolution process in 2005. 

● Digirad failed, over a period of years, to secure NRC-licensed radioactive materials 

from unauthorized removal or access. The materials were stored at Digirad client sites as 

opposed to sites under the direct control of the company. Contrary to NRC requirements, the 

company did not control and maintain constant surveillance over such materials when they were 

in storage in unsecured areas. Specifically, client physicians and other staff had unauthorized 

access to doses of technetium-99m over several years since they had keys to the areas where the 

materials were stored. 

“This created the potential for licensed material to be accessed and used by unauthorized 

individuals,” Mr. Collins wrote. 

Digirad took part in a predecisional enforcement conference with NRC staff on Jan. 17, 

2008. The purpose of the conference was to allow the company to discuss the apparent 

violations, their significance, their root causes and any corrective actions. Digirad described the 

corrective actions taken by the company, which included verifying the credentials of all 

authorized user applicants; contacting all company physician-supervisors to validate the 

information they submit; and ensuring that all present and future lease agreements carry 

appropriate “exclusive control” language requiring proper access control for licensed radioactive 

materials. 

The company is required to provide the NRC with a written reply within 30 days. 

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