During annual MQSA inspections, mammography personnel are sometimes found to not meet one or more of the personnel qualifications. May this individual (interpreting physician) continue to lawfully provide mammography services to the facility?
While an individual’s qualifications are still under evaluation, that individual may continue to provide mammography services to the facility in his or her area. Once it has been determined that an individual DOES NOT meet one or more of the initial personnel qualifications (e.g., a "No" answer has been entered in response to one or more of the initial qualification questions), that individual may lawfully provide mammography services to the facility only under the direct supervision of a fully qualified individual.
The direct supervision must continue until such time as the individual meets the qualifications, at which time he/she may resume working independently.
Personnel who fail to meet a continuing requirement must also go under direct supervision as stated above. However, FDA may allow for a limited time exception to this rule when the imposition of direct supervision on the person failing to meet the continuing requirement would result in the facility having to cease providing mammography services.