The Annual MQSA Inspection: What Facilities Can Do To Help

The annual inspection under the Mammography Quality Standards Act (MQSA) involves an MQSA-certified inspector assessing a facility's compliance with the MQSA quality standards. To minimize disruption to patient care, the standard inspection questions focus on areas that the FDA believes most directly impact the quality of mammography. However, the facility remains responsible for meeting all regulatory requirements, not only those specifically checked during the annual MQSA inspection.

The inspector will provide the facility with at least five business days’ notice before an inspection, and will work with the facility to schedule the inspection at a convenient time. The facility will need to set aside approximately 20 minutes for each mammography unit to be free from clinical use so the inspector can observe the technologist acquiring 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. To help minimize disruptions, facilities can organize and consolidate the records which need to be presented to the inspector.

The tables below provides a general summary of what to prepare for and present at the annual inspection.

Personnel Records	Explanation
License/Certification	Current license and/or certification for all personnel
Continuing Education	15 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
Mammographic Modality Training	8 hours in any modality in which personnel was not initially trained *Note: 8 hours of training in any manufacturers digital breast tomosynthesis (DBT) system satisfies the mammographic modality training requirement for DBT.
Initial Qualifications	Documentation of initial education and training for all personnel new to the facility since the previous inspection

 

Physicist Survey	Explanation
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) All survey data for any equipment located off site, such as display devices (review workstations) Documentation of corrective action related to each recommendation, if applicable
Medical Equipment Evaluation (MEE)	If new mammography equipment or display devices 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.

 

Quality Assurance and Quality Control (AC/QC)	Explanation
Consumer Complaint Policy	Written and documented system for collecting and resolving consumer complaints to include: Providing consumer with adequate directions for filing serious complaints with facility’s accreditation body  Reporting unresolved serious complaints to the accreditation body  Maintaining each serious complaint for 3 years
S.O.P. for QC Tests	The facility should make available any QC manual utilized by the facility to conduct QC testing on the unit and any image output devices, even if located off-site
QA Personnel List	Written personnel list to include Lead Interpreting Physician, Quality Control Technologist, and Medical Physicist
Clinical Image Quality (EQUIP)	System for corrective action when clinical images are of poor quality Documentation of clinical image quality review 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 mammography unit manufacturer’s QC manual (or ACR DM QC Manual if using alternative standard) All QC test data for any equipment located off site, such as display devices Documentation of corrective action(s) from each unit or display device, if applicable

 

Medical Records	Explanation
Mammography Reports	At least five mammography reports will be selected by the inspector to determine if the report contains all of the following: Patient name and an additional patient identifier Facility name and location (city, state, ZIP, telephone number) Date of exam Identification of interpreting physician Acceptable overall assessment of findings category wording Acceptable assessment of breast density
Patient Lay Summary Letters	Examples of patient lay summary letters will be reviewed to determine if the letter(s) contain all of the following: Patient name Facility name, (full) address, telephone number Federal breast density notification statement
Communication of Results	Facility personnel should be prepared to explain how the facility communicates results to patients and referring physicians

 

Medical Audit and Outcome Analysis

Explanation

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 •    Calculated metrics (positive predictive value, cancer detection rate, recall rate) •    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 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 close-out discussion, which should take approximately 15-20 minutes.

The inspector will send the final inspection report via e-mail, mail, or fax within five business days of the inspection. Any adverse inspection observations identified should be corrected as soon as possible. Depending on the severity of the observations, specific regulatory time frames for correcting and responding to them may apply. These requirements, as well as instructions on how and where to respond to any adverse inspection observations, will be included 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 during the same visit. Therefore, the times above may vary, and the state may have additional requirements.

By preparing documentation in advance, setting aside time for the phantom aquisition/review and the close-out discussion, and following the directions for responding to observations, facilities can help ensure a more positive inspection experience. For more information on the documentation needed during an annual inspection or on MQSA requirements in general, please refer to the Small Entity Compliance Guide, which assists mammography facilities in complying with the MQSA regulations.