Radiology

Regulations and Standards

by Ashley Hu, MD, and Jane Dascalos, MD

Introduction

The Mammography Quality Standards Act (MQSA) is a law passed by the federal government to regulate the quality and standards for a mammographic facility and its images. The Food and Drug Administration (FDA) is responsible for overseeing this process, by conducting inspections as is required by the law. Currently, all mammographic facilities must be accredited by an FDA-approved accreditation body in order to operate and be compensated by insurance companies. Without this accreditation, the facility is deemed to be operating illegally. The MQSA outlines the requirements needed for operation and accreditation, including personnel training, equipment standards, imaging reporting, specifications, and storage, and quality assurance.

Personnel Training

There are established training requirements for personnel involved in the process of obtaining and interpreting a mammogram. The following are required for the different categories of personnel:

Interpreting physicians

  • Initial qualifications
    • Medical license to practice in that state
    • Certified in diagnostic radiology or 3 months of formal training in mammography
    • 60 hours of medical education in mammography, with 15 of those hours required to be 3 years immediately prior to the qualification
    • Interpretation of 240 mammograms in the 6 months immediately prior to qualification or if in residency, in any 6 month period in the last 2 years of residency
  • Continuing experience and education
    • Interpretation of 960 mammograms in 24 months
    • 15 hours of continuing medical education in 36 months
    • 8 hours of training for a new mammographic modality if not previously trained in that area

Radiologic technologists

  • Licensed to perform radiographic procedures in that state or certified by an FDA-approved body
  • 40 hours of mammographic training under a qualified instructor, with a minimum of 25 exams done under direct supervision, and at least 8 hours of training in each mammographic modality
  • Continuing education: 15 hours of continuing education in 36 months
  • Continuing experience: 200 mammograms in 24 months

Medical physicists

  • Initial qualifications
    • Licensed by state or certified by an FDA-approved body
    • Master’s degree or higher with 20 semester hours of physics
    • 20 hours of documented training in surveying mammography facilities
    • Experience of surveying at least 1 mammographic facility and 10 mammographic units
    • If qualified before 04/28/1999
      • Bachelor’s degree or higher with at least 10 semester hours of physics
      • 40 hours of documented training in surveying mammography facilities
      • Surveyed at least 1 mammography facility and 20 mammography units
    • Continuing qualifications
      • 15 hours of continuing education units in 36 months
      • Survey 2 mammography facilities and 6 mammography units in 24 months
      • 8 hours of training before qualifying to survey a new mammographic modality

Equipment

Equipment used for mammography cannot be used for general purposes; it must be specialized for mammography. Additional technical specifications for components of the mammographic unit, such as the image receptor and compression paddle, are outlined in detail in the MQSA documents.

Mammography Reports and Storage

The contents of a mammographic report are clearly outlined by the MQSA. Each report must contain:

  • Patient name
  • Additional patient identifier
  • Date of examination
  • Name of interpreting physician
  • BI-RADS assessment
  • Further recommendations based on BI-RADS assessment

This final report is sent to the health care provider in a timely manner, but no later than 30 days after the examination date. If the findings are suspicious (BI-RADS 4) or highly suggestive of malignancy (BI-RADS 5), the interpreting physician also has a responsibility to communicate these findings directly to the health care provider as soon as reasonably possible. In addition to the final report, an additional report written in language understandable by the patient must be delivered to the patient within 30 days of the examination.

Mammographic films and reports must be kept for a minimum of 5 years for actively operating facilities, and a minimum of 10 years for facilities that are no longer performing mammograms. The original films and reports must also be sent to a health care institution, physician, or patient if requested by the patient or on behalf of the patient.

Mammographic image requirements

On each mammographic image, the following information must be present:

  • Patient name
  • Additional patient identifier
  • Date of examination
  • View and laterality
  • Facility name and location
  • Technologist information
  • Cassette/screen identification
  • Mammographic unit identification if the facility has more than one unit

These are to be placed in a permanent manner on a visible location on the film, without obscuring breast anatomy.

Quality Assurance and Control

Individuals responsible for the quality of the services and images at a mammographic facility include the appointed Lead Interpreting Physician, interpreting physicians, medical physicist, and appointed Quality Control Technologist.

To ensure that the equipment is working correctly and optimally, certain tasks are required to be performed consistently. These range from daily to annually, and are most specifically outlined in the MQSA for screen-film systems. For non-screen-film systems, the MQSA recommends quality checks based on manufacturer recommendations. The only exception to this is that the average glandular dose to the FDA phantom breast should not exceed 3 milligray per exposure on a single craniocaudal view, regardless of imaging modality.

References

  1. Interpreting Physician: Mammography (Revised 12-12-19). ACR Accreditation Support. Accessed June 29, 2021.
  2. Mammography Quality Standards Act Regulations. U.S. Food & Drug Administration. Accessed June 29, 2021.
  3. Medical Physicist: Mammograph (Revised 12-12-19). ACR Accreditation Support. Accessed June 29, 2021.
  4. Radiologic Technologist: Mammograph (Revised 12-12-19). ACR Accreditation Support. Accessed June 29, 2021.