1. Being approved by an FDA-approved accreditation organization:
In order to become MQSA certified, a mammography facility must be approved by an FDA-accredited organization such as the American College of Radiology (ACR). This process includes submitting an application that contains detailed information about the mammography equipment and staff qualifications. After approval, the facility will receive a MQSA Certificate of Approval that must be displayed in view of patients.
2. Meeting FDA- or state-approved standards:
The mammography equipment must meet both FDA and state standards for accuracy, safety and quality. This includes regularly testing the equipment to ensure it is functioning properly and making sure it meets all necessary radiation protection regulations. The staff must also be trained to use the equipment according to FDA guidelines.
3. Passing an annual MQSA inspection:
Mammography facilities must pass an annual MQSA inspection conducted by either the state or FDA personnel in order to maintain certification. During this process, they will review the facility's operations and records pertaining to the equipment, personnel, and patient care.
4. Displaying the MQSA Certificate of Approval prominently in view of patients:
The MQSA Certificate of Approval must be displayed prominently in view of patients at all times. This ensures that any patient who is receiving a mammogram knows that it is being conducted at an approved facility and that they are receiving quality care.
5. Conducting an annual Medical Physicist Survey on all mammography equipment:
In order to make sure the mammography equipment is functioning properly, facilities must conduct an annual Medical Physicist Survey on all mammography equipment used. During this survey, the medical physicist will test each piece of equipment to make sure it meets FDA standards.
6. Maintaining ACR accreditation by an FDA-approved accrediting body:
Mammography facilities must maintain their ACR accreditation by an FDA-approved accrediting body in order to remain certified. The facility will be monitored on a regular basis and must meet all requirements set forth by the accrediting body in order to keep its certification. This includes meeting certain personnel qualifications, patient care standards, and medical physics standards.