Mammography Facility Inspections

The Radiologic Health Branch conducts inspections of X-Ray machines used for mammography every year. Both federal law, the Mammography Quality Standards Act (MQSA) administered by the U.S. Food & Drug Administration (FDA), and State law apply to screening and diagnostic mammography. The inspection is generally a combined State and FDA-MQSA inspection.

• ​NOTICE - Breast Density Notice (posted 8-15-2024)​​​

Mammography Program

General Requirements

• All mammography facilities must have the FDA-MQSA certificate posted.
• All mammography machines must have the State certificate posted. A facility must ensure all areas or rooms with a permanently installed X-ray machine is be posted with a “Caution X-Ray” sign at the entrances to those areas or rooms.
• Copies of all individual operator or supervisor and operator permits and certificates issued by the Radiologic Health Branch must be posted for public viewing. In lieu of posting the individual documents, a list may be posted that meets requirements in 17 CCR 30305(e). The hospital must maintain copies of the documents even if the list is posted.
• Staff must be provided any emergency safety procedures related to the X-Ray machines the utilize. (17 CCR 30255.)
• The facility shall assure that all persons under his or her jurisdiction that are operating or supervising the operation of X-ray equipment for purposes of radiologic technology, as defined in 17 CCR 30400, comply with the Radiologic Technology Act (RT Act) and the regulations adopted pursuant to the RT Act. (17 CCR 30305.5.) Individual permit / certificate requirements and their scope of practice are specified in the following 17 CCR sections:
• Certified Supervisors & Operators
  
• Radiology Certificate - 30460
• Radiography Permit - 30461(c)
  
• Radiologic Technologist holding a Mammographic Radiologic Technology Certificate - 30441 and Health & Safety Code (HSC) section 106980

 Other Resources