Calcified and noncalcified plaque by CCTA. Source: Fabian Bamberg, MD, University of Munich

Heart Check America has closed following an investigation by the X-ray Certification Unit of the Colorado Department of Public Health and Environment.

Inspections by the X-ray Certification Unit in April confirmed that Heart Check America, located in Denver, was conducting CT scans on patients without an order from a Colorado licensed physician, along with other violations of the Colorado Rules and Regulations Pertaining to Radiation Control. On April 14, the unit ordered the company to scan only the approximately 5 percent of its clientele referred by physicians.

On April 25, the unit ordered the company to cease all scanning operations and followed up with a notice of violation sent to the facility on May 2. When phone calls went unanswered, department representatives visited the company’s offices on May 5 and found them empty, according to a statement.

The company had been using an Imatron electron beam CT scanner to perform heart scans, lung scans, quantitative computed tomography (QCT) bone density scans, virtual colonoscopies and whole-body scans advertised as a “virtual physical,” including heart, lung, abdomen, pelvic and aortic aneurysm scans.

In a May 6 letter to the Colorado Medical Board, Brian Vamvakias, X-ray Certification Unit leader, wrote:
“We are concerned these scans are being done on some patients without a Colorado licensed physician’s order, and that the scan results are not being read by a radiologist in a timely fashion. We are also concerned that the machine used to scan the patients does not produce images of diagnostic quality sufficient for the intended diagnosis. Finally, we do not feel a whole body scan is an appropriate screening tool for an asymptomatic patient. Our concern is based on the premise that exposure to radiation from medical procedures must have some benefit for the patient. If the images from this system are not sufficient to determine presence of a disease, or if these exams are not being read by a radiologist and the results are not being communicated to the patient, then the patients receive the risk of the radiation dose with no benefit at all.”

The notice of violation from the state health department addressed the lack of a Colorado-licensed physician at the facility and other violations of the radiation control regulations. The department informed the medical board that the other concerns listed by Vamvakias are not within the jurisdiction of state radiation regulations. The letter urged the board to investigate this facility and its practices to ensure all Colorado regulations are being followed.

Heart Check America also operates clinics in Nevada, Illinois, New York, South Carolina, California and Washington, D.C.