Regulators fine Digirad for nuclear medicine violations

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Digirad fined for nuclear medicine equipment. Source: Digirad  

The Nuclear Regulatory Commission (NRC) on Monday issued a $6,500 fine to radiology equipment maker Digirad Imaging Solutions for two violations at the company's nuclear medicine centers.

NRC inspectors identified the apparent violations during an inspection conducted from July 20 to 25, 2006, and during follow-up reviews at Digirad’s base and client sites in New Jersey and Pennsylvania, according to an NRC release.

According to the Associated Press (AP), the Poway, Calif.-based company’s first violation was for licensing an unauthorized doctor to operate nuclear imaging equipment.

In multiple amendment requests from November 2001 to April 2006 seeking to add facilities to its license as base sites, Digirad submitted information that was not complete and accurate in all material respects, the NRC said.

Specifically, the facilities were sites owned by clients of Digirad and some were not controlled by the company. The amendments resulted in several locations being added to Digirad’s NRC license as base sites even though Digirad did not provide the controls to be used at a licensed base site. Further, the amendments led to several doses of technetium-99m being delivered from a manufacturer or distributor to a Digirad client even though the clients did not hold an NRC license to possess such material, according to the agency.

Regulators said the second violation is for failing to monitor radioactive materials while they were in storage. The agency said the materials should have been stored at secure Digirad-owned sites, rather than at their client's locations, according to the AP.

The NRC said that “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 have had unauthorized access to doses of technetium-99m over several years since they had keys to the areas where the materials were stored.”

In response to the first violation, Digirad said the physician was authorized to use the equipment because he had received training from an already-approved physician, however, the NRC asserts that the training never actually occurred.

In January, company officials met with the NRC to explain the apparent problems and outline fixes, reported the AP. Digirad spokesman Mark Casner said the company has already made corrections that go "above and beyond the government regulations," and plans to pay the fine, according to the AP.