How to Prepare for Inspections
Mammography Inspections
Annual inspections of radiation machines used for mammography are performed by Iowa Department of Health and Human Services inspectors who are qualified to perform MQSA inspections. States are allowed to have more stringent requirements than MQSA requires. Most of the mammography specific rules can be found in 641 IAC Chapter 41.6.
For additional MQSA requirements: FDA Policy Guidance Help System
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
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.
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:
- FDA's Inspection News page
- Important Information about the Enhancing Quality Using the Inspection Program (EQUIP) Initiative
- Enhancing Quality Using the Inspection Program (EQUIP) Frequently Asked Questions - Facilities
- Quality Assurance / Quality Control Attestation by the Lead Interpreting Physician (LIP)
The inspector will review all personnel records to ensure that interpreting physicians, mammography technologists and medical physicists meet the initial and continuing qualifications.
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.
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: FDA Policy Guidance Help System
Stereotactic Biopsy Inspections
Annual inspections of radiation machines used for stereotactic biopsies are performed by Iowa Department of Health and Human Services inspectors. Most of the stereotactic biopsy specific rules can be found in 641 IAC Chapter 41.7.
The information below is intended for guidance only and does not encompass all aspects of a stereotactic biopsy inspection. For specific questions regarding your facility’s stereotactic biopsy inspection, please contact Iowa HHS Mammography Program staff.
Remember that the information available for State of Iowa stereotactic biopsy inspections may not reflect all requirements if you are an ACR Stereotactic Breast Biopsy Accredited facility. Contact the ACR for questions regarding accreditation at 800- 227-6440 or visit their website.
The inspector will ask you to perform a phantom image test in the same manner in which you perform the test for your stereotactic quality control program.
The inspector will also perform a digital field (receptor) uniformity test on your unit.
The inspector will review all personnel records to ensure that stereo physicians, technologists and medical physicists meet the initial and continuing stereo qualifications.
The applicable quality control manuals for your stereotactic unit need to be available for reference during inspection.
QA of a facility’s stereotactic breast biopsy program that will be verified includes but is not limited to:
- Designated responsible IP
- Annual review of QA program
- Quality control records
- Stereotactic breast biopsy facilities must perform quality control testing as outlined in IAC Chapter 41.7 rules.
- Any additional tests as required by the manufacturer must also be performed.
- Medical Physicist surveys
- The medical physicist must annually perform equipment testing as outlined in IAC Chapter 41.7 rules.
- Safety Standards
- Dosimetry records
- Equipment operated from a shielded position
- Medical Records Review
- Five (5) random reports from date ranges provided by the inspector
- Medical Stereo Audit
- Reviewed and signed annually
- Service records