The Iowa HHS Mammography Program works closely with the Food and Drug Administration (FDA) to ensure the safety and reliability of mammography examinations provided by facilities within Iowa with the ultimate goal of helping to detect breast cancer at an early and treatable stage.
The Mammography Quality Standards Act of 1992 (MQSA) and subsequent Mammography Quality Standards Reauthorization Act (MQSRA) amendments require that all facilities providing mammography services be accredited and certified. The Iowa Code 136C.15 provides additional requirements for mammography facilities within Iowa.
Accreditation & Authorization
All mammography units must obtain and maintain accreditation by a Food and Drug Administration (FDA) approved accrediting body (AB). In Iowa, facilities must use the American College of Radiology (ACR) to accredit their mammography units.
All facilities providing mammography or stereotactic breast biopsy services in Iowa must be authorized by the State of Iowa. This includes Iowa facilities accredited by the ACR and mobile facilities who provide services in Iowa.
New Unit or New Facility Authorization
Any mammography unit that will be used for mammography services must be accredited by an FDA approved accrediting body (AB) prior to use for patient imaging. Mammography units that will be used in Iowa must also be authorized by the Iowa HHS Mammography Program. You must have both authorization approval by Iowa HHS and accreditation approval from the ACR before using your new unit for patient exams.
If you are installing a new mammography unit and/or opening a new mammography facility, you must contact the ACR directly for information on accreditation. Once the ACR has approved a mammography unit/facility application, the Iowa HHS Mammography Program, as your certifying agency (CA), will be notified of your facility's certification eligibility by the AB.
You must also contact the Iowa HHS Mammography Program staff for instructions on authorization requirements. Other documentation required prior to approval includes:
- A Mammography Equipment Evaluation (MEE) performed by your Medical Physicist, and
- A radiation shielding plan for the room where the unit will be located
You will be notified by Iowa HHS when your authorization application has been approved.
All mammography units and facilities must complete the Reauthorization process with Iowa HHS at a minimum of every three years. Iowa HHS Mammography Program staff will notify you when it is time to complete the reauthorization process and instructions will be provided at that time. In addition, a phantom image will be reviewed annually at the time of your inspection to ensure quality requirements are being met.
The ACR will notify each mammography facility when you are due to complete the reaccreditation process. Instructions will be given at that time.
For more information, please contact the ACR.
Facilities must be certified by Iowa HHS (an FDA approved certification agency) prior to providing mammography services. Certification is maintained by continued accreditation of the mammography units at the facility and annual inspections in good standing. The annual inspections are performed by Iowa Department of Health and Human Services inspectors who are qualified to perform MQSA inspections.