A recent ABC News story reported that the FDA issued an alert urging hospitals nationwide to review their safety protocols for CT scans.
Why? An unfortunate group of patients who had CT scans at Cedars-Sinai Medical Center in Los Angeles received eight times the normal dose of radiation during a CT brain perfusion scan. The overdose was discovered when a patient reported lost patches of hair following a CT scan.
According to the ABC News report, in a statement released Oct. 12th "The error, which Cedars-Sinai attributed to a 'misunderstanding' about an incorrectly programmed CT machine, remained unchecked for 18 months. The error involved 206 people and exacerbated recent concerns that patients nationwide are being exposed to excess radiation during medical testing."
An incorrectly programmed CT machine going unchecked for 18 months is hard to accept. Patients depend on professional, competent regulatory oversight. Most accredited hospitals must adhere to strict Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) regulations. JCAHO sets standards and issues accreditation to those healthcare organizations that meet those standards. JCAHO conducts periodic on-site surveys to verify that "an accredited organization substantially complies with Joint Commission standards and continuously makes efforts to improve the care and services it provides." In addition, each state and city has regulations requiring inspections for healthcare equipment in hospitals usually through the Department of Health to ensure patient safety and the quality of patient care. The inspection requirements and timing vary by city and state but most provide inspections on some regular basis. How this error could have gone unnoticed for 18 months is difficult to understand.
In 2008, New York City Department of Health and Office of Radiological Health performed a week long comprehensive review of Hospital for Special Surgery's entire radiology program for QA/QC policies, procedures, radiation safety, physicist reports, equipment calibration and ongoing monitoring. At the end of the inspection, the Department received accolades for its performance and our department received a 100% satisfactory score.
All imaging centers and physician's offices that have CT, MRI and X-Ray equipment should be required to go through a similar review process. Imaging centers and doctors who self-refer to their own in-office X-ray and imaging equipment should be held to the same standards as hospitals or risk being shut down in the name of patient safety. ABC News reports that, "financial obstacles could prevent proper quality control at many health care facilities." A health care facility cannot afford to skip safe practices. It is similar to the airline industry, where the company and pilots must ensure the proper level of quality control or limit their business to what can be performed safely and accurately.
Dr. Kimberly Applegate, Vice Chair of Quality and Safety in the Department of Radiology at Emory University School of Medicine, was quoted in the ABC News report stating, "I am concerned by the economic pressures that may lead health care systems to lay off physicists and engineers that do not provide clinical revenue, yet they are our radiation safety experts that work hand-in-hand with the diagnostic radiologists."
As more and more nonradiology physicians are looking to augment their bottom line revenue with the latest in imaging equipment, we are beginning to see more non-accredited imaging centers opening their doors. According to Shawn Farley, Director of Public Affairs for the American College of Radiology (ACR), a new Medicare rule will force imaging facilities to become accredited by the ACR but this law does not go into effect until Jan. 1, 2012.
Patients - a few words of advice. It will take two years before Imaging Centers will be forced to go through the ACR accreditation process. Also, there are varying regulations by states' departments of health regarding safety standards for imaging centers and owners of in-office equipment. With that in mind, the next time your physician asks you to walk down the hall for an MRI, X-Ray or CT scan, ask about radiation protocols, who will be conducting the examination and who will be reading the results. These questions may not make your physician happy, but you will be taking critical steps to help ensure you receive safer, higher quality patient care.