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
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.
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.
As of January 1, 2020, the State of Iowa is no longer an AB. All Iowa mammography facilities must be accredited by the American College of Radiology (ACR).
At times, a facility that installs new mammography equipment may experience payment problems with the Centers for Medicare & Medicaid Services (CMS) for DBT or FFDM services. The FDA does not provide MQSA certificates that specifically state that a facility is certified to perform DBT or FFDM. Instead, they send CMS a weekly file containing the most recent approval information. Your payer must look at the current MQSA file to see whether your facility is certified to perform FFDM and/or DBT mammography exams.
CMS Transmittal 828 explains the handling of these files. You may wish to provide a copy to your local payer.
You may contact the appropriate CMS headquarter representatives:
Medicare Carrier for non-payment of the professional component
Medicare Fiscal Intermediary (FI) for non-payment of the technical component
Please provide them with your facility’s 6-digit FDA ID number from your MQSA certificate and your MQSA expiration date.
Final MQSA regulations require that each mammography report include an overall final assessment of the mammography examination. The acceptable wording for the assessment categories are as follows:
Negative
Benign
Probably Benign
Suspicious
Highly Suspicious of Malignancy
Incomplete: Need Additional Imaging Evaluation
Known Biopsy Proven Malignancy
Post Procedure Mammograms for Marker Placement
Accepted variations to these assessment terms can be found on the Acceptable Variations for Assessment Terms document link.
Iowa Administrative Code - Chapter 41.6(4)b.(8) requires a separate and distinct section entitled “Assessment” be included in each mammography report.The appropriate assessment term or equivalent must be included in the assessment, and this will be reviewed at the time of inspection.
A medical physicist survey is required whenever a mammography facility installs new mammography equipment onsite or begins to use equipment located at an off-site location. Mammography equipment is considered to be but not limited to the mammography unit and review workstation (RWS).
Additionally, existing equipment must also be evaluated after major repairs, component replacements or some software updates. Note that FFDM equipment requires reference to the appropriate quality control manual to determine medical physicist requirements in these situations. If you are relocating mammography equipment, contact Iowa HHS Mammography Program staff for specific guidance.
Additional information about new units can be found on our Authorization and Accreditation page. Contact the Iowa HHS Mammography Program staff for more information.
