Breast imaging

Breast imaging, planned as its own program.

Screening and diagnostic mammography, tomosynthesis and breast ultrasound each carry their own requirements. Radstead scopes them separately, reviews MQSA obligations for mammography and defines result-letter and recall responsibilities before any service begins.

Four components

Four services, not one checkbox.

Choose a component to see what is defined together and what stays with the facility.

Screening mammography

Read against priors, answered to two audiences.

Screening mammograms are typically read in batches against prior examinations, and results go to the patient as well as the referring clinician.

Define together

  • Reading schedule and how turnaround is measured
  • Access to prior and outside mammograms
  • Who prepares lay summary letters and schedules recalls
  • Breast density reporting and notification wording

Arranged separately

The facility’s lead interpreting physician role and its MQSA quality assurance program.

MQSA essentials

What MQSA means for a remote arrangement.

The Mammography Quality Standards Act is administered by the U.S. Food and Drug Administration. These are the points that most affect how remote reading is set up; the FDA pages listed below are the authority.

Facilities
Mammography facilities must hold MQSA certification and accreditation from an approved body, be surveyed annually by a medical physicist and be inspected at least once a year.
Interpreting physicians
Physicians who interpret mammograms must meet MQSA’s initial and continuing qualification requirements, with training specific to each mammographic modality they read, including DBT.
Reports and patient letters
Under the amendments effective September 10, 2024, mammography reports and the lay summaries sent to patients include breast density information.
Outcomes audit
Facilities maintain a medical outcomes audit that follows results for each interpreting physician, so remote readers take part in it.

In practice, before the first mammogram is read remotely

  • Each remote reader’s MQSA qualifications are documented for the facility’s inspection records.
  • DBT training is documented before tomosynthesis studies are assigned.
  • Ownership and timing of lay summary letters are agreed; they are often generated from facility systems.
  • The lead interpreting physician role is settled as its own facility arrangement.
  • Audit data flows are agreed: who compiles results, and who reviews them.
  • Prior mammograms, including outside studies, are available for comparison.

The breast pathway

From examination to follow-up.

Breast imaging continues after the report: letters, recalls and audit are part of the service. Each step has an owner.

  1. Examination and history

    Your facility

    Acquisition, prior studies and the reason for the examination.

  2. Interpretation with comparison

    Reading radiologist

    Read against priors, with DBT where included.

  3. Assessment and report

    Reading radiologist

    Assessment category, breast density and recommendations.

  4. Patient letter

    Agreed together

    Lay summary content, timing and which system sends it.

  5. Recall and diagnostic work-up

    Your facility

    Scheduling, additional views and ultrasound.

  6. Outcomes audit and review

    Agreed together

    Results tracked by reader and reviewed on a set cadence.

Questions

Breast imaging, answered plainly.

Can screening and diagnostic mammography be scoped separately?

Yes. Screening is often read in batches against priors, while diagnostic work-ups may need decisions during the patient’s visit. Many facilities scope them differently, with a clear handoff when a screening result leads to a diagnostic examination.

Who sends the patient result letter?

MQSA requires a lay summary for the patient. The letter is often generated by facility systems from the report; who prepares it, what it says and when it goes out are agreed before service begins.

Is tomosynthesis handled differently?

Yes. DBT studies are larger, and MQSA requires training specific to the modality before a physician interprets it. Reader documentation, workstations and bandwidth are checked for DBT separately.

Is the lead interpreting physician role part of remote reading?

No. It is a facility role with quality-assurance responsibilities under MQSA. Any arrangement for it is agreed on its own terms and reviewed against MQSA requirements.

Can breast ultrasound be included without mammography?

Yes, as its own scope: screening or diagnostic, with correlation to any available mammography and with reader qualifications confirmed for breast ultrasound specifically.

References

Primary sources

MQSA requirements are set by the FDA. These pages are the authority for the summary above.

  1. Mammography Quality Standards Act (MQSA) and MQSA ProgramU.S. Food and Drug Administration
  2. Important Information: Final Rule to Amend the Mammography Quality Standards ActU.S. Food and Drug Administration · Amendments effective September 10, 2024

Coverage planner

Scope breast imaging with the rest of your coverage.

The planner separates screening from diagnostic scope for breast ultrasound and mammography, and asks whether DBT is included, so the brief starts with the right questions.