Standards for Mammography Facilities in New York State
As of October 1, 1994, any facility that performs, interprets, or develops mammograms must be certified by the Food and Drug Administration (FDA) in order to be lawfully in operation. The Mammography Quality Standards Act (MQSA), passed by Congress, established uniform standards for providers of mammography services across the country.
In order to receive certification from the FDA, a facility must apply to an accrediting body. Facilities in New York State apply to the American College of Radiology (ACR) for accreditation. Facilities applying to the ACR forward information about radiation dose, image quality, and reports on equipment testing for evaluation and approval. Upon approval, the ACR notifies the FDA with a list of accredited facilities.
After notification by the ACR, the FDA mails a certificate to each facility to be displayed prominently in an area where it can be seen by patients. Certificates in Spanish are available upon request by the facility. Any facility that has been fully approved by the ACR receives a FDA certificate valid for a three year period. Each facility is inspected on an annual basis by an MQSA qualified inspector.
Prior to undergoing any mammography, a patient should ask personnel at the site if the facility has been accredited by the ACR and certified by the FDA to conduct mammography. The facility must have their certificate on display for the patient to review. The certificate will display the name of the facility as well as the period of the time the FDA has approved the facility to conduct mammography.