HARRISBURG – The Department of Environmental Protection has fined the Heart of Lancaster Regional Medical Center $15,000 for performing mammograms with equipment that failed required weekly tests.
A DEP inspection at the center this past January found equipment that had failed the required image tests on seven occasions from June to September 2006. The facility did not identify the cause of this failure and continued to use the equipment without correcting the problem, which are both violations.
Independent radiologists reviewed the 298 mammograms conducted at the facility from June to September and found, however, that all of the tests were reliable. The facility, at 1500 Highlands Drive, Lititz, has corrected the violations and is now in compliance with law.
“We will not tolerate actions that potentially put the public’s health at risk,” said DEP Secretary Kathleen A. McGinty. “Pennsylvania women and their families need to know we will act quickly and decisively to make sure the mammography equipment is being tested according to requirements, and is meeting all quality assurance standards.”
DEP conducts annual inspections of the state’s approximately 400 mammography facilities under a contract with the federal Food and Drug Administration. The FDA has jurisdiction over mammography facilities under the Mammography Quality Assurance Standards Act, but DEP can also act under the state’s Radiation Protection Act.
“The good news is the vast majority of Pennsylvania mammography facilities consistently meet the strict federal standards set for this important medical test, and women should continue to have confidence in the results of these tests,” McGinty said.