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. For ACR resources, click here.
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.
Reauthorization
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.
Reaccreditation
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.
ACR Resources:
- 1-800-227-6440
- https://www.acraccreditation.org/Contact-Us
- http://www.acraccreditation.org/Modalities/Mammography
Forms
- Mammography Facility Application - contact the Iowa HHS Mammography Program staff for a new unit or new facility application.
- Mammography Room Shielding Plan