The U.S. Food and Drug Administration (FDA) has the responsibility of regulating mammography testing equipment and procedures around the nation. Mammography uses medical equipment in conjunction with low-dose X-rays to scan human breast tissue. Mammography machines produce X-ray pictures, which can then be scrutinized by doctors for the presence of cancer.
Accreditation
According to Kathleen A. Franke of the Accreditation and Certification Branch of the FDA, all facilities offering X-ray testing for breast cancer must be accredited by either a state as certifier (SAC) or a private certification organization approved by the FDA. To receive accreditation, mammography facilities must meet personnel qualifications, record-keeping and testing requirements, clinical image reviews, and equipment specifications. Facilities whose accreditation has expired or has been revoked must become re-accredited.
Certification
After a facility meets all requirements set by the FDA and receives accreditation, the FDA requires a facility to become certified under the Mammography Quality Standards Act (MQSA). Only Illinois and Iowa offer state certification, so clinics in other states must become certified directly by the FDA. If the FDA finds the mammography facility compliant with regulations, the FDA will grant either a provisional (temporary) license for up to six months or a full three-year certification.
Inspection
According to the FDA's website, the agency requires annual inspections of mammography facilities. Usually, the states have the responsibility of conducting mammography inspections under contract with the FDA. The FDA allows an inspection fee of $2,150 to be charged for one mammography machine. Successive units in the same facility received reduced rates. A site with 10 mammography machines will pay $4,400 as of 2010. If the inspector finds noncompliance with the MQSA, he or she will require the mammography provider to fix these problems, with a re-inspection fee of $1,144. If a facility fails an inspection and does not fix the problems, accreditation and MQSA certification may be revoked.
Results
FDA mammography requirements require certified facilities to send a report to the FDA of all exam results within 30 days. Any incidences of suspected or highly suggestive malignancy of breast tissue must be reported to the FDA, including the course of action that the facility intends to take to treat the incidence of breast cancer. The FDA will review facility records to make sure that the facility is in compliance with FDA procedures.
Complaints
The FDA expects mammography facilities to have a system in place to address all patient complaints. These complaints should be resolved by the medical facility. If the complaints cannot be resolved, patients can direct their complaint to the organization that certified the mammography center, which should be listed on the facilities Mammography Quality Standards Act (MQSA) certificate.
Tags: mammography facilities, become certified, breast cancer, breast tissue, Mammography Quality, Mammography Quality Standards, must become
