Before a new mammography facility may legally perform mammography on patients, it must apply for accreditation through the American College of Radiology (ACR). Please see the ACR website for more information on accreditation.
Certification is a process that is administered by DHEC/FDA (Food and Drug Administration). DHEC issues a Mammography Quality Standards Act (MQSA) certificate upon notification by the ACR that a mammography facility has been accredited.
Only DHEC/FDA certified facilities can lawfully provide mammography services. The Centers for Medicare and Medicaid Services (CMS) will only reimburse for mammography performed at a DHEC/FDA certified facility. Please see the FDA website for information regarding reimbursement issues.
Inspections
DHEC inspects all mammography providers in South Carolina to make sure facilities meet the requirements of the federal Mammography Quality Standards Act (MQSA) as well as state regulations. DHEC has partnered with the FDA to perform the federal MQSA inspection and enforce federal standards. This federal inspection is conducted at the same time as the state inspection. Please see the FDA website Policy Guidance Help System for more information on complying with the MQSA.