Radiation-Emitting Products

The Annual MQSA Inspection: What Facilities Can Do To Help

The annual inspection under the Mammography Quality Standards Act (MQSA) is the time when an MQSA certified inspector assesses a facility's compliance with MQSA quality standards. To reduce the amount of time away from the facility’s job of patient care, the scope of the standard inspection questions is designed to check areas that FDA believes have the most direct bearing on facility performance of quality mammography. However, the facility remains responsible for meeting all requirements of the regulations, not only those specifically checked at the time of the annual inspection.

The inspector provides the facility with advance notice of inspection at least five business days before an inspection. The inspector works with the facility to schedule the inspection at a time convenient for the facility. The facility will need to set aside approximately 20 minutes for each mammography unit to be free from clinical use in order for the inspector to observe the technologist acquire a phantom image and for the inspector to score the phantom image. Facility personnel may conduct their usual duties during the inspection, but should be available if the inspector has questions or needs assistance. Facilities can help the inspector minimize disruption to the facility's activities by organizing and consolidating records which need to be presented to the inspector. We hope the chart below is helpful in knowing what to prepare for and present at the annual inspection.

Personnel
License/CertificationCurrent license or certification for all personnel
Continuing Education15 CME completed within past 36 months for all personnel
Continuing Experience
  • Interpreting Physicians- interpreted 960 exams/24 months
  • Radiologic Technologists- performed 200 exams/24 months
  • Medical Physicist- survey 2 facilities and 6 units/24 months
New Modality Training8 hours in any modality in which personnel was not trained  *Note that now 8 hours of training in any manufacturer’s digital breast tomosynthesis system satisfies the new mammographic modality training requirement.
Initial QualificationsDocumentation for all personnel new to the facility
Physicist Survey
Annual
  • Completed within 10-14 months of the previous survey to include:
    • Physicist's tests and results
    • Evaluation of the technologist's QC testing
    • Recommendations for any corrective action(s)
  • Corrective action related to each recommendation, if applicable
Medical Equipment Evaluation  (MEE)If new mammography equipment or image output devices (review workstations) were obtained, disassembled and then reassembled (either at the same or a new location), or a major component was changed or repaired since the previous inspection. 
*Note - check with the unit manufacturer if it is unclear whether a unit change or repair requires a MEE, and present the inspector with documentation if the manufacturer determines that a MEE was not required. 
QA/QC
Consumer Complaint PolicyWritten and documented system for collecting and resolving consumer complaints to include:
  • Definition of a serious complaint
  • Provide consumer with adequate directions for filing serious complaints with facility’s accreditation body 
  • Report unresolved serious complaints to the accreditation body 
  • Maintain each serious complaint for 3 years
QA Personnel ListWritten personnel list to include Lead Interpreting Physician, Quality Control Technologist, and Medical Physicist
Clinical Image Quality
  • System for corrective action when clinical images are of poor quality
  • Documentation of clinical image quality review (*this requirement is not in effect until 1/1/2018)
  • System for LIP oversight of QA/QC records and corrective actions options of
    • LIP Attestation or
    • LIP available for questions in person or by phone or
    • Signed SOP
QC Test Data
  • All QC test data as required by the regulations or for FFDM and DBT units, the manufacturer’s QC manual
  • All QC test data for any equipment located off site, such as review workstations
  • Any necessary corrective action(s) from each unit, if applicable 
Medical Records
Medical ReportsAt least five medical reports will be selected by the inspector to determine if the report contains all of the following:
Communication of ResultsFacility personnel should be prepared to explain how the facility communicates results to patients and referring physicians
Medical Audit and Outcome Analysis
 Written documentation of analysis to include:
  • All positive mammograms interpreted as “Suspicious” or “Highly suggestive of malignancy" are included
  • Determination of whether biopsy specimen was benign or malignant
  • Analysis for facility as a whole
  • Analysis for each individual interpreting physician

During the exit interview with facility personnel, the inspector will review the results of the inspection and discuss any adverse inspection observations. It is recommended that the lead interpreting physician, inspection contact, quality control technologist, radiology manager, and, if possible, the facility’s designated MQSA most responsible individual attend the exit interview. The facility should plan to set aside approximately 15-20 minutes for the exit interview. The inspector will send the final inspection report via e-mail, mail, or fax within five business days of the date of the inspection. Any adverse inspection observations identified during the inspection should be corrected as soon as possible. Depending on the severity level of the observations found during the inspection, specific regulatory time frames for correcting and responding to observations may apply. These requirements, as well as instructions on how and where to respond to any adverse inspection observations, will be included along with the final inspection report.

As a reminder, if your facility is in a state that also conducts a state inspection, the MQSA and state inspection often happen at the same inspection visit. Therefore, the times above may vary, and the state may have additional requirements that need to be met.

By preparing documentation in advance, by setting aside time for the phantom activities and the exit review, and by following the directions for responding to observations, facilities can help themselves and their inspectors have a more positive inspection experience. For more information on documentation needed during an annual inspection or on MQSA requirements in general, please visit the MQSA Policy Help Guidance System. 

Page Last Updated: 02/23/2017
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