The X-Ray Certification Unit of the Colorado Department of Public Health and Environment has ordered Heart Check America to pay a $3.2 million penalty, the largest ever imposed by the state’s radiation program.

Heart Check closed its Denver office in early May after state inspectors confirmed it was conducting CT scans on patients without an order from a Colorado licensed doctor, along with other violations of the Colorado rules and regulations pertaining to radiation control.

The compliance order and assessment of administrative penalties names Heart Check America-Denver, Sheila Haddad, David Haddad, Lisa Haddad and Todd Kaplan. The penalty covers nine violations, including:

• Failure to have a Colorado-licensed physician supervise the facility’s scanner;
• Exposing patients to CT without a written order from a Colorado-licensed physician;
• Failure to have policies and procedures ensure safe use of the CT scanner;
• Failure to register as a healing arts screening program with the state;
• Failure to monitor employee’s radiation exposure;
• Failure to use adequately trained employees to operate the CT scanner;
• Failure to conduct annual reviews of the company’s radiation protection program to ensure compliance with state regulations;
• Failure to conduct a shielding design evaluation of the CT scanner; and
• Failure to maintain documented protocols for selecting the appropriate scanner setting for different types of diagnostic tests.

“When we contacted Heart Check America in April, we gave them an opportunity to correct their violations,” said Brian Vamvakias, x-ray certification unit leader. “They stopped all communication with us and we were left with no choice but to proceed with escalated enforcement and assess these penalties.”

The people named in the order have 30 days to pay the penalty or to request a hearing. Money collected from penalties goes to the state’s general fund, not to the department assessing the penalty, the state indicated.

“Heart Check America was exposing approximately 150 customers per week to potentially unnecessary radiation doses without a doctor’s involvement,” Vamvakias said. “These exams can provide important diagnostic information to a medical professional and are necessary in many instances to determine the presence or extent of a disease. But patients should submit to x-ray and CT exams on the recommendation of their doctor, not on the advice of a salesman.”

Heart Check also operates or operated clinics in Nevada, Illinois, New York, South Carolina, California and Washington, D.C. The company’s assets will be auctioned to satisfy debts. Colorado Department of Public Health and Environment officials will be present to ensure that whoever purchases the CT scanner complies with state radiation safety regulations, the department stated.

The record-setting fine comes on the heels of a lawsuit in Illinois and an investigation into the company’s sister group, Cancer Check America, in South Carolina.