Mammography Inspections
The information below is intended for guidance only and does not encompass all aspects of an inspection. For specific questions regarding your facility’s mammography inspection, please contact IDPH Mammography Program staff.
Inspector Tests Performed Onsite
Quality Assurance
Medical Physicist Surveys
Quality Control Testing
Designation of Responsible Individuals
Technique Charts
Consumer Complaints
EQUIP
Personnel Qualifications
Medical Records Review
Medical Outcomes Audit
Inspector Tests Performed Onsite
Mammography - The inspector will ask you to perform a phantom image test in the same manner in which you perform the test for your quality control program. The inspector will then perform measurements of the radiation output of your unit to determine the average glandular dose for the phantom.
Return to top
Quality Assurance (QA)
Equipment QA
The applicable quality control manuals for your mammography unit and reading workstations (RWS) need to be available for reference during inspection. Additional documents your inspector will need to review includes but is not limited to the following:
Medical Physicist Surveys
Your inspector will need a copy of all medical physicist surveys that were conducted for each mammography unit, on site RWS and any off site RWS during the inspection time frame. See the Frequently Asked Questions page for more information on medical physicist testing requirements.
Quality Control Testing
The inspector will review all QC records for adequate performance of each test. Facilities with FFDM and DBT units must perform quality control testing as outlined by their manufacturer's quality control manual and IAC Chapter 41.6 rules, as applicable.
Return to top
General QA
The inspector will review your policies and procedures to ensure that they meet all MQSA and State of Iowa rules.
Designation of Responsible Individuals
Designation of QC Personnel, Lead Interpreting Physician, Quality Control Technologist, and Medical Physicist.
Technique Charts for each mammography unit
The facility must retain an updated technique chart to show techniques and procedures used in conducting mammograms continue to be met.
Consumer Complaint Process
The facility must have the following consumer complaint mechanism that includes establishing a written system for consumer complaints, maintaining a record of each serious complaint for at least 3 years, provide instructions for a consumer to file a serious complaint with the facility’s accreditation body (AB) if the facility cannot provide resolution and report any serious unresolved complaints to the AB.
EQUIP - Enhancing Quality Using the Inspection Program
The inspector will have questions and review documentation related to the facility's EQUIP program. These clinical image quality-related regulations were developed by the FDA's Division of Mammography Quality Standards in order to add emphasis of continued image quality for all mammography facilities.
For additional information on the EQUIP requirements:
Return to top
Personnel Qualifications
The inspector will review all personnel records to ensure that interpreting physicians, mammography technologists and medical physicists meet the initial and continuing qualifications.
For additional Information:
Return to top
Medical Records Review
The inspector will ask for an overview of your facility's process for providing the mammography interpretation results to both the referring physicians and the patient. The process must ensure that within 30 days of the mammography examination, each patient will receive a letter with her mammography results written in layman's terms.
MAMMOGRAPHY INTERPRETATION REPORTS:
The inspector will also review five (5) or more interpretation reports to ensure that they include:
- The name of the patient and an additional patient identifier;
- Date of examination;
- The name of the interpreting physician who interpreted the mammogram;
- The patient’s breast density;
- For more information on the Breast Density Rules in Iowa, please refer to our Frequently Asked Questions page.
- A separate and distinct section titled "Assessment" that includes an assessment category.
- Assessment categories are classified as one of the following:
(A) “Negative:” Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall he explained);
(B) “Benign:” Also a negative assessment;
(C) “Probably Benign:” Finding(s) has a high probability of being benign;
(D) “Suspicious:” Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;
(E) “Highly suggestive of malignancy:” Finding(s) has a high probability of being malignant;
(v) In cases where no final assessment category can be assigned due to incomplete work-up, “Incomplete: Need additional imaging evaluation” shall be assigned as an assessment and reasons why no assessment can be made shall be stated by the interpreting physician; and
(vi) Recommendations made to the health care provider about what additional actions, if any, should be taken. All clinical questions raised by the referring health care provider shall be addressed in the report to the extent possible, even if the assessment is negative or benign.(vii) Information on a patient's breast density, as categorized by an interpreting physician at the facility based on standards as defined in nationally recognized guidelines or systems for breast imaging reporting of mammography screening, including the breast imaging reporting and data system of the America College of Radiology.
PATIENT LAY LETTERS FOR BREAST DENSITY
The inspector will review five (5) or more patient lay letters to ensure that they include the following required information on breast density:
- The breast density as designated in the mammography interpretation reports included in the patient lay letter with a reference to a department-accepted site or document where the patient can obtain more information about breast density.
- For patients categorized as having heterogeneously dense breasts or extremely dense breasts, or an equivalent determination by another nationally recognized density gradient system, the notification to the patient shall include evidence-based information on dense breast tissue, the increased risk associated with dense breast tissue, and the effects of dense breast tissue on screening mammography and shall be stated in language appropriate for the facility's patient population.
For more information on the Breast Density Rules in Iowa:
Return to top
Medical Outcomes Audit
Each facility must maintain a mammography medical outcomes audit program to include all mammograms interpreted as positive (Bi-RADS Category 4 or 5). Each positive assessment must be correlated with the pathology results for the associated biopsy, with documented attempts for those pathology results that are unavailable.
The inspector will want to review your facility's system for collecting and reviewing outcome data for all mammograms performed. An analysis of the positive mammogram correlation and any false negative mammograms discovered should be performed after the data has been collected. This is usually six months to one year after the reported time frame.
For example:
- Data collected for 1/2012-12/2012
- Monitor during 2013 for false negatives from any 2012 mammogram (negative mammograms with subsequent cancer diagnosis)
- Review and signature by audit review physician in 12/2013
- Inspector Review during 2014 facility inspection
For additional information:
Return to top