Breast imaging is a proven and essential tool in efforts to detect and diagnose breast cancer. An actionable diagnosis starts with a clear, detailed, quality image. That’s why there are strict standards around the equipment and technology used in medical imaging as well as certifications for radiologic technologists who perform the exam and the radiologists that interpret them.
Outpatient imaging offices must meet strict quality and safety standards established by the U.S. Food and Drug Administration (FDA) and the American College of Radiology (ACR). These requirements give patients and their medical providers confidence in the quality of imaging exams.
FDA Certification for Mammography
FDA inspections are performed to determine if outpatient imaging offices providing mammography services meet expectations outlined in the Mammography Quality Standards Act (MQSA). The FDA inspects mammography programs and radiology offices every year to:
- Evaluate imaging equipment
- Verify the credentials and training of technologists and radiologists
- Review random quality control data from each mammography unit
The Mammography Quality Standards Act (MQSA) became law in 1992 and FDA certification based on quality standards became mandatory in 1994.
The ACR is the leading accrediting body for all types of imaging, including mammography and breast imaging. Receiving ACR accreditation is considered the industry gold standard for quality. The ACR evaluates offices in many areas to determine the overall quality of patient imaging.
- Personnel standards – ACR requires and sets standards for the qualifications, certifications and Continuing Medical Education (CME) credits of physicians and technologists. This ensures the competence of those medical providers caring for patients.
- Image quality – ACR requires submission of mammography images taken on each mammography unit at each office.
- Patient protections – ACR accreditation, in addition to the FDA certification, provides proof that medical imaging centers have proper quality control measures in place.
Imaging offices that perform mammography must be in good standing with the ACR in order to perform exams and procedures on patients.
Breast Imaging Center of Excellence Designation
The ACR offers an additional quality designation specifically for breast imaging that goes beyond mammography alone. To be recognized as an ACR Breast Imaging Center of Excellence (BICOE), every aspect of breast imaging that a practice performs must meet specific ACR standards and receive ACR accreditation.
Quality Imaging Every Day
The concerted, collective effort between radiologists, technologists and staff is required to ensure that medical imaging practices meet and maintain both FDA certification and ACR accreditations.
These quality standards are important to patient care.
- Quality Assurance – Image quality is very important in medical imaging. Image blurring, a lack of detail, and errors in clarity, orientation or intensity are reasons a medical condition may be undetected, misdiagnosed or untreated.
- Insurance Billing – ACR certification is required for imaging providers to bill certain exams to Medicare.
- Accountability – The ACR website allows patients to provide feedback related to concerns or complaints about the facility exam process or personnel.
WakeRad UNC REX is proud to have been continuously certified by the FDA and accredited by the ACR since the accreditations became mandatory in the early 1990s. We were also the first outpatient provider in the Triangle to earn the ACR’s BICOE designation and continue to maintain that quality standard. Our doctors, technologists and staff are honored by the trust medical providers and patients have placed in us for more than 66 years. To learn more about radiology accreditations, visit WakeRad.com/Accreditations.