Dr. Chikarmane Benchmarks and Audits in Breast Imaging

Sona A. Chikarmane, MD

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Benchmarks and Audits in Breast Imaging

Introduction

Hello, my name is Sona Chikarmane. I am an assistant professor of radiology at Brigham and Women's Hospital and a staff radiologist in the Breast Imaging Division. Today, I'll be talking about benchmarks and audits in breast imaging.

Objectives

Our topic today will cover a few different things:

  • Review the MQSA audit
  • Discuss definitions important for the audit
  • Review the ACR BI-RADS audit
  • Discuss both mammography and ultrasound, as well as breast MRI
  • Review what to do with the results
  • Go over some updates with the BI-RADS New Edition slated to come out in Q4 of 2023, as well as EQUIP

Topics

1. MQSA Audit

The Mammography Quality Standards Act (MQSA) was passed by Congress in 1992 and is overseen by the FDA. The components of MQSA include protocols, accreditation, quality control, and audit data. Today, I will focus on audit data.

  • Minimal audit data required by MQSA
  • Suggested additional recommendations by the American College of Radiology in the BI-RADS manual

2. Importance of Audits

Various studies demonstrate screening outcomes. Quality is critical in detecting early clinically occult breast cancers, identifying deficiencies, facilitating research, and reducing adverse medical-legal consequences.

  • Demonstrates success in detecting early breast cancers
  • Identifies deficiencies and facilitates research
  • Reduces adverse medical-legal consequences

3. Lead Interpreting Physician (LIP)

The LIP is designated for each mammography facility and is required for QA requirements. This physician oversees staff requirements, facility equipment performance, and operations, ensuring compliance with mammography report and medical records.

  • Establishes and maintains a quality assurance program
  • Ensures daily, weekly, semi-annual, and annual QA is performed
  • Maintains medical outcomes data and addresses serious complaints

4. Positive Screening Studies

A positive screening study in mammography is defined by ACR BI-RADS as anything that is not routine screening, with actions taken before the next screening interval. Screening studies should be given a BI-RADS 0; BI-RADS 3, 4, and 5 are highly discouraged and should not be used in screening assessments.

  • Additional diagnostic images are considered positive in handheld ultrasound
  • For automated screening breast ultrasound, it would be similar to offline batch screening

5. BI-RADS 4 Subcategorization

BI-RADS 4 subcategorization provides more meaningful audit data with malignancy rates ranging from 2% to 95%. BI-RADS 4A is 2-10%, 4B is 10-50%, and 4C is 50-95%. This subcategorization supports patient care and provides more meaningful practice audits.

  • BI-RADS 4A: 2-10% malignancy rate
  • BI-RADS 4B: 10-50% malignancy rate
  • BI-RADS 4C: 50-95% malignancy rate

6. Cancer Characteristics

Cancer characteristics in breast imaging are defined as DCIS or invasive within the screening interval and must be primary breast malignancies. The goal is to identify small, early-stage, node-negative cancers.

  • Cancers should be DCIS or invasive within the screening interval
  • Must be primary breast malignancies
  • Goal is to identify small, early-stage, node-negative cancers

7. Definitions and Metrics

Definitions from the ACR BI-RADS lexicon include true positive, true negative, false negative, and false positive. Positive predictive values (PPV) include PPV1, PPV2, and PPV3.

  • True positive: Cancer diagnosis within one year of a positive examination
  • True negative: No cancer within one year of a negative examination
  • False negative: Cancer within one year of a negative examination
  • False positive: No cancer at one year of a positive screening exam
  • PPV1: Number of cancers in all positive screening exams
  • PPV2: Number of cancers in patients recommended for biopsy
  • PPV3: Number of cancers in all biopsies performed

8. Recall Rate and Cancer Detection Rate

Recall rate or abnormal interpretation rate includes all true positives and false positives over all screening exams. The cancer detection rate is the number of cancers per thousand patients.

  • Recall rate includes all true positives and false positives
  • Cancer detection rate is the number of cancers per thousand patients

9. ACR BI-RADS Recommendations

The ACR BI-RADS recommendations for the audit include collecting modalities, audit period dates, and additional patient risk factors. They recommend separating screening and diagnostic studies, collecting data for BI-RADS 0, 3, 4, and 5, and biopsy results, including histological type, grade, and staging data.

  • Separate screening and diagnostic studies
  • Collect data for BI-RADS 0, 3, 4, and 5
  • Collect biopsy results, including histological type, grade, and staging data

Conclusion

In conclusion, we've discussed the goal of the audit, the MQSA minimal audit, and the ACR BI-RADS complete audit for mammography, ultrasound, and breast MRI. We've also covered what to do with the results and recent updates to the audit. Thank you for your time.