By Cynthia E. Keen, AuntMinnie.com staff writer

March 24, 2010 -- The state of Maryland has fined Johns Hopkins University $370,000 as part of a settlement regarding alleged violations of state law relating to the university's use of ionizing radiation and its handling of radioactive materials for medical and research purposes.

Without admitting liability, Johns Hopkins University and Johns Hopkins Hospital, both in Baltimore, signed a settlement agreement with the state to pay the fine relating to 19 violations allegedly identified during three state inspections in 2007. The state's Department of the Environment said the fine was one of the largest financial penalties it has ever issued.

Of the total amount, fines for $360,000 represented the university's alleged failure to properly secure radioactive materials used in university and hospital laboratories from unauthorized removal or access, and failure to prevent unauthorized access to rooms containing medical devices using radiation. The settlement agreement, dated March 3, references unlocked rooms, locks to rooms with keys in them, and locked doors that could be shoved open.

The department also cited alleged violations that include an inadequate program to conduct appropriate background checks of individuals with unescorted access to radioactive materials, and a lack of a documented program to respond to unauthorized access to radioactive material and devices.

In addition, three contract employees conducting fluoroscopy on a pig were identified as not wearing radiation monitoring devices, and they allegedly failed to stop the fluoroscopic activities when ordered to do so by the state inspector.

Other violations include evidence of beverages being taken into laboratories where radioactive material was used, failure to keep radiation measurement equipment in calibration, failure to label radioactive waste, and failure to conduct weekly surveys for removable contamination.

Johns Hopkins Hospital was fined $10,000 for a violation of administering radiation treatment to the incorrect area of a cancer patient in May 2009. The error was made when a patient with two anatomical areas for treatment received the radiation dose prescribed for the second area in the first area, according to a statement from Johns Hopkins Hospital.

A Johns Hopkins spokesperson told AuntMinnie.com that the patient was not injured or over-radiated because the radiation dose delivered was within the prescribed levels of the planned dose. The patient was told immediately what happened, and the adverse event was reported to state officials and the U.S. Nuclear Regulatory Commission (NRC) within regulatory time frames.

"Although differences of opinion remain about the allegations, Johns Hopkins believes it was in the best interest of all parties to settle the claims in an amicable manner," according to the statement. The university's statement also emphasized that its facilities fully complied with state law during inspections in 2008 and 2009, no patients or visitors were exposed to any potential harm, and there was no radiation exposure to the environment.

By Cynthia E. Keen
AuntMinnie.com staff writer
March 24, 2010

NRC hits Philadelphia VA with $227,500 fine, March 17, 2010

Congress surprised at lack of medical regulation oversight, February 26, 2010

Copyright © 2010 AuntMinnie.com


Last Updated np 3/23/2010 1:51:46 PM