Preparing for Inspections
The Iowa Department of Public Health conducts annual inspections to verify compliance with both the MQSA and State of Iowa rules.
While onsite, the mammography inspector will test each mammography unit and evaluate the evidence of the required Quality Control tests. Each inspection takes about 4 hours - but the time will vary for each facility.
Remember - The inspector will be evaluating everything in the facility since the previous inspection. This includes required documentation for any mammography unit, processor/printer, technologist and radiologist.
Film/Screen
The following will be verified for each film screen mammography unit:
- X-ray Field to Image Receptor alignment
- Compression Paddle Alignment
- Beam Quality (HVL)
- Average Glandular Dose
- AEC/Exposure Reproducibility
- Phantom Image Quality
Additional items verified by the inspector:
- FDA Processor STEP test
- Darkroom Fog test
- Certificate location is visible to patients
The facility's performance of the following Quality Assurance and Quality Control tests during the inspection period will be verified. Please have documentation representing each of these items available for the inspector:
- Quality Assurance Personnel are clearly assigned:
- Lead Interpreting Physician
- QC Technologist
- Medical Physicist
- Infection Control Procedure - specific to mammography
- Infection Control List
- Consumer Complaint Procedure
- Processor QC - Daily
- Phantom Image QC - Weekly
- Fixer Retention Test - Quarterly
- Repeat Analysis - Every 250 patients or Quarterly (whichever comes first)
- Compression QC - Semi Annually
- Screen Film Contact Test - Semi Annually
- Darkroom Fog Test - Semi Annually
- Medical Physicist Survey - provide a photocopy of the most recent survey for the inspector.
- Medical Records Content - the inspector will ask for reports.
- Medical Audit - compilation of biopsy tracking signed by the reviewing interpreting physician - False Positives, False Negatives, True Positives, True Negatives.
- Qualification documents for each Interpreting Physician who interpreted mammography at the facility:
- Initial Qualifications
- Iowa Medical License
- Continuing Education (15 CME's in previous 36 months)
- Continuing Experience (960 mammogram reads in previous 24 months)
- Qualification documents for each Radiologic Technologist who performed mammograms at the facility:
- Initial Qualifications
- Iowa Permit to Practice
- Continuing Education (15 CEU's in previous 36 months)
- Continuing Experience (200 mammograms performed in previous 24 months)
- Iowa Approval Letter for the Medical Physicist
Full Field Digital (FFDM)
- Average Glandular Dose
- Beam Quality (HVL)
- AEC/Exposure Reproducibility
- Phantom Image Quality
Additional items verified by the inspector:
- Certificate location is visible to patients
The facility's performance of the following Quality Assurance and Quality Control tests during the inspection period will be verified. Please have documentation representing each of these items available for the inspector:
- Quality Assurance Personnel are clearly assigned:
- Lead Interpreting Physician
- QC Technologist
- Medical Physicist
- Infection Control Procedure - specific to mammography
- Infection Control List
- Consumer Complaint Procedure
- QC Tests as outlined in the mammography unit Quality Control Manual. (this may be different than the application specialist's notes)
- QC Tests as outlined in DICOM Printer Quality Control Manual. (Selenia Manuals include the required DICOM Printer QC)
- QC Tests as outlined in the Review Workstation Quality Control Manual.
Please contact IDPH 
if you have questions about the performance or applicability of any of the FFDM tests.
- Medical Physicist Survey - provide a photocopy of the most recent survey for the inspector.
- Medical Records Content - the inspector will ask for reports.
- Medical Audit - compilation of biopsy tracking signed by the reviewing interpreting physician - False Positives, False Negatives, True Positives, True Negatives.
- Equipment/Processor Service Records
- Qualification documents for each Interpreting Physician who interpreted mammography at the facility:
- Initial Qualifications
- 8 hours Initial FFDM Category 1 CME
- Iowa Medical License
- Continuing Education (15 Cat. 1 CME's in previous 36 months)
- Continuing Experience (960 mammogram reads in previous 24 months)
- Qualification documents for each Radiologic Technologist who performed mammograms at the facility:
- Initial Qualifications
- 8 hours FFDM CEU
- Iowa Permit to Practice
- Continuing Education (15 CEU's in previous 36 months)
- Continuing Experience (200 mammograms performed in previous 24 months)
- Iowa Approval Letter for the Medical Physicist
Preparing for Stereotactic Breast Biopsy Inspections
The following will be verified for each stereotactic breast biopsy unit:
- Average Glandular Dose
- Beam Quality Assessment (HVL)
- AEC/Exposure Reproducibility
- kVp Accuracy and Reproducibility
- Digital Receptor Uniformity
- Phantom Image Quality
- Equipment operated from a shielded position
The facility's performance of the following Quality Assurance and Quality Control tests during the inspection period will be verified. Please have documentation representing each of these items available for the inspector:
- Quality Assurance Personnel are clearly assigned:
- Supervising Physician
- QC Technologist
- Medical Physicist
- Localization Accuracy - Daily
- Phantom Image QC - Weekly
- Visual Checklist - Monthly
- Compression QC - Semi Annually
- Medical Physicist Survey - provide a photocopy of the most recent survey for the inspector.
- Medical Records Content - the inspector will ask for report
- Medical Audit - compilation of biopsy tracking. Positive Biopsies, Negative Biopsies, Discordant Biopsies, Repeated Biopsies.
- Annual Review of Stereotactic Program by Supervising Physician
- Personnel Radiation Monitoring Badge Reports
- Equipment Service Records
- Qualification documents for each Physician who performed stereotactic breast biopsies at the facility: (remember to include all mammography qualifications for all physicians who are also mammography interpreting physicians)
- Initial Stereo Qualifications
- Iowa Medical License
- Continuing Education (3 stereo CME's in previous 36 months)
- Continuing Experience (12 stereotactic biopsy procedures every 12 months)
- Qualification documents for each Radiologic Technologist who performed mammograms at the facility: (remember to include all mammography qualifications for all technologists who are also mammography technologists)
- Initial Qualifications
- Iowa Permit to Practice
- Continuing Education (3 stereo CEU's in previous 36 months)
- Continuing Experience (12 stereotactic procedures in every 12 months)
- Iowa Approval Letter for the Medical Physicist
