At the time of the inspection, the sole interpreting physician, radiologic technologist, and/or medical physicist at a facility is found to not meet one of their requirements. Must the person and the facility immediately stop practicing mammography?
If personnel fail to meet a requirement, the facility will be cited. The actions that the facility and the persons involved must or should take will be dependent on the specific circumstances that exist at the facility. For example, if the radiologic technologist fails to meet a requirement, the technologist can continue to perform mammography under the direct supervision of the interpreting physician (as long as the physician meets the technologist qualifications). If the physician fails to meet a requirement, he/she must stop interpreting mammograms independently; however, the facility can continue to perform mammography with the studies being interpreted by a different interpreting physician at a later time. Under no circumstance can the interval between performing and providing the results of the examination exceed 30 days. If the medical physicist fails a requirement, the facility will be cited but can continue to perform and interpret mammograms.
Because the consequences of having a facility cease performing mammography services, even for a short time, can be so detrimental to patient access and patient care, the inspector must take special actions in such cases. If both the interpreting physician and radiologic technologist fail to meet their requirements or other conditions exist that would cause shut down of the facility’s operations, the inspector should immediately contact the FDA Hotline for further instructions. In those cases where FDA determines that there is not an immediate risk to human health, the facility can continue to use the personnel for a limited time so that the problem(s) can be corrected without adversely affecting patient care and access.