NRC NEWS

 U.S. NUCLEAR REGULATORY COMMISSION 

 Office of Public Affairs, Region I

 475 Allendale Road, King of Prussia, Pa.

www.nrc.gov

 

No. I-06-004 January 30, 2006

Contact: Diane Screnci, 610/337-5330 E-mail: opa1@nrc.gov

Neil Sheehan, 610/337-5331

NRC CITES NUCLEAR MEDICINE FIRM FOR VIOLATION OF REQUIREMENTS

The Nuclear Regulatory Commission has cited a nuclear medicine company for a violation of

agency requirements involving the submission of inaccurate information. The enforcement action

against Digirad Imaging Solutions, Inc., does not entail a fine but does require several corrective

actions by the firm.

“This enforcement action strikes the proper balance between making it clear that the

submission of inaccurate information to the NRC is unacceptable and ensuring that concrete steps are

being taken to prevent a recurrence,” said Mike Johnson, Director of the NRC’s Office of

Enforcement. “Nuclear medicine licensees routinely provide the NRC with complete and accurate

information. However, the occurrence of these violations is an opportunity for members of that

community to review their processes and procedures to ensure the NRC continues to receive the

correct information and that any inaccuracies are promptly identified and corrected.”

Digirad, which has offices in New York State and California, holds a mobile medical license

from the NRC authorizing the possession of nuclear materials for medical diagnostic purposes. Under

the license, the firm is allowed to use the nuclear materials at specific facilities in Indiana, Michigan,

Missouri, New Jersey, Pennsylvania, Virginia and West Virginia. In addition, it is permitted to use the

radioisotopes at temporary job sites anywhere in the United States where the NRC has jurisdiction for

the use of certain licensed radioactive materials.

In a license amendment request sent to the NRC on Oct. 16, 2003, Digirad provided

information regarding the training and experience of a physician. Specifically, Digirad submitted a

statement attesting that the doctor had the required training and experience to be named as an

Authorized User on the license issued to the company by the NRC. However, an investigation

conducted by the NRC’s Office of Investigations (OI), completed in June 2005, determined that

inaccurate training and experience information was submitted to Digirad by the physician for the

purpose of adding the physician as an Authorized User on the company’s NRC license.

In response to the OI finding, Digirad requested the use of the Alternative Dispute Resolution

(ADR). ADR is a process in which a neutral mediator with no decision-making authority assists the

NRC and licensees in reaching an agreement resolving any differences regarding an enforcement

action. An ADR mediation session between NRC staff and Digirad representatives was held on Nov.
14, 2005, in King of Prussia, Pa. As a result of that session, as well as subsequent discussions held on

Dec. 14 and 15, 2005, a settlement agreement was reached.

The elements of the agreement include:

C The NRC and Digirad agreed to disagree on whether the violation represented careless

disregard of agency requirements. While the NRC agreed that Digirad did not

knowingly submit the inaccurate information, the agency also pointed out that the

company is responsible for the acts and omissions of its agents.

C It was acknowledged that Digirad implemented several corrective actions prior to

attending the ADR session on Nov. 14. Also, the company agreed to take further

actions to ensure similar violations will not occur, including submitting commentary to

nuclear medicine publications so that others in the industry will learn from the incident.

C The company agreed to audit the training and experience credentials of a certain

number of Authorized User applicants each year.

C The NRC agreed to issue a Severity Level III Notice of Violation to Digirad but to not

issue a civil penalty.

The terms of the enforcement action have been confirmed via a Confirmatory Order issued by

the NRC to the company.

The physician involved also took part in a separate ADR, and was issued a Severity Level III

Notice of Violation and agreed to take certain corrective actions to ensure a similar violation did not

occur in the future.

Both the company and the physician may respond to the enforcement actions in writing within

30 days.

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