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FOR IMMEDIATE RELEASE
February 25, 2011

Contact: Lawrence Ragonese, DEP (609) 292-2994
Lawrence Hajna, DEP (609) 984-1795
Donna Leusner DHSS (609) 984-7160

UMDNJ FAILED TO TEST X-RAY EQUIPMENT AT THE UNIVERSITY HOSPITAL
PATIENTS NOT HARMED, BUT HOSPITAL FACES A MAJOR PENALTY

(11/P25) TRENTON - Commissioner Bob Martin today announced that DEP has uncovered a failure by the University of Medicine and Dentistry of New Jersey to conduct required quality control tests on its medical x-ray equipment for at least the past seven months at The University Hospital, in direct violation of State law and which could have jeopardized the health of patients.

The DEP sent a team of inspectors to UMDNJ last Friday to inspect the equipment. They determined the hospital had not performed any quality control testing within the radiography and fluoroscopy portion of the radiology department since before August 2010. Daily calibrations are required for all of the hospital's medical x-ray equipment.

Subsequent baseline performance tests done last week by an independent, licensed medical physicist and UMDNJ staff found the 48 machines in question to be operating within safe parameters. There is no evidence of any health or safety risk to any of the estimated 14,000 patients who have undergone testing at the hospital since last August.

A detailed look at these medical devices at The University Hospital is continuing by DEP investigators, who are trying to determine why this management problem occurred. The State Department of Health and Senior Services, which oversees New Jersey hospitals, also is investigating the situation.

"This seems to be an egregious violation of state regulations,'' said Commissioner Martin. "Fortunately, we found no fault, so far, in the equipment, and there is no evidence of any harm to patients due to this unacceptable negligence. We expect an institution like UMDNJ to adhere to a much stricter standard of conduct to protect the people who come to them for health care. What happened here is unacceptable, and we will ensure this problem is corrected immediately.''

"This raises concerns regarding an adequate system for quality oversight,'' added Department of Health and Senior Services Commissioner Dr. Poonam Alaigh. "The Department will investigate and take appropriate action.''

Enforcement penalties against UMDNJ will be sought after DEP investigators gather more information on the situation, said Commissioner Martin, who noted the state Attorney General's Office has been advised of the situation.

DEP investigators will audit UMDNJ records to ensure compliance with required radiological machine testing. The DEP also has demanded that UMDNJ implement an acceptable quality assurance program at its Newark trauma center and that it supply all pertinent supporting documents to the DEP by March 8.

Machines in question are general radiographic and fluoroscopic devices. Higher dose machines at the Newark facility, such as CT Scan equipment, have so far been found to have been properly calibrated and maintained.

On Feb. 10, the DEP received an inquiry from a concerned individual alleging the hospital was failing to perform required quality control tests on medical x-ray equipment, as required by the State Radiation Protection Act. Included are required calibrations of the machines to ensure proper dosages of radiation and accuracy of results. DEP inspectors converged on the Newark medical facility on Feb. 18 and found those calibrations were not being done.

"They are required to continuously monitor the performance of radiography equipment and report any divergences to management for corrective action,'' said DEP Director of Environmental Safety and Health Paul Baldauf. "They admitted to us that they have not been following required procedures. This is a very unusual occurrence, the first time we have ever encountered such a lack of compliance by a hospital in New Jersey on such a wide scale.''

The DEP has a team of five inspectors who periodically check radiological devices in hospitals, as well as at doctors' and dentists' offices, and laboratories statewide. The last inspection of UMDNJ's Newark trauma center occurred in October 2009. There were no violations for x-ray equipment discovered at that time.

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Last Updated: February 25, 2011