Clinical Testing: Breast Ultrasound (Revised 4-8-2025)

Revision History

The ACR Breast Ultrasound Accreditation Program is facility-based. Facilities must apply for accreditation for all services provided. For example, if no biopsies are conducted, the facility should only apple for accreditation in breast ultrasound. If both core-needle biopsies (CNB) and fine needle aspiration cytology (FNAC) of solid masses are performed (not cyst aspirations or axillary lymph nodes), the facility must also apply for the Ultrasound-Guided Breast Biopsy Module and submit both types of cases. Only one set of images per type (i.e., simple cyst, solid mass, CNB and/or FNAC) is required, regardless of the number of breast ultrasound units of the number of physicians at the facility.

If it is determined you need to change exams the change request must be submitted as a support ticket request before submitting your testing package. There you may select the topic/category of exam change, fill out the modality ID number and specify the exam or module you wish to add, remove or change. You will be contacted once the change is complete to upload and submit your testing package.

You may print generic Test Image Data Forms (attached below) to assist you in gathering data. Do not submit these forms. You must log onto the ACR accreditation database to enter and submit data into your online testing package.

During accreditation review, at least two radiologist reviewers will assess the following case attributes:

• Visualization of the cyst or solid mass in the correlating mammogram
• Ability of the performing radiologist to appropriately triangulate the cyst or solid mass
• Image quality
• Examination identification and labeling

Important Considerations When Selecting Clinical Cases

• Submit examples of your best work. The ACR Committee on Breast Ultrasound Accreditation understands that all images obtained during all ultrasound examinations or ultrasound-guided breast biopsy procedures may not meet these criteria. Consequently, sufficient time is allowed to select cases that are examples of "best work". ACR reviewers will evaluate your images accordingly.
• Do not submit images that are performed on models or volunteers
• Do not send the mammography or pathology reports; they will not be sent to the ACR reviewers. Please note that the ACR will purge any submitted materials containing protected health information (PHI) that are not necessary for the accreditation review process.
• Your supervising physician must review and approve images prior to uploading them to the ACR for review. The supervising physician is ultimately responsible for previewing the images submitted for review.
• All examinations submitted must have been performed within six months of the date that the testing package link was released to the facility. No images will be accepted for review that predate this by more than six months.
• All images for each exam must be from the same patient
• Do not submit implant cases
• As a general rule, do not submit male patients. If there are exceptional circumstances, please reach out to ACR staff.
• The area being evaluated or biopsies must be visible and easily appreciated on all submitted images:
  • Correlating mammogram (lesion must be clearly circled)
  • All sonogram images

Correlating Mammogram

A 2-view, 2D and/or 2D synthesized mammogram (CC and MLO/ML/LM)

• The mammogram may be from an outside facility
• The initial mammogram must have been performed within 60 days prior to the sonograms
• Do not submit post-procedure images (i.e., post clip images)
• Include the entire breast with the lesion being evaluated; the lesion should be well-visualized and clearly circled on each image. If you do not circle the lesion, the exam will fail accreditation because the reviewers will not be able to determine if the intended lesion was imaged.
• Circling more than one lesion will result in accreditation failure because ACR reviewers may be uncertain which lesion was evaluated or biopsied
• Do not use radiopaque markers in place of the ROI (i.e., skin markers)
• Individual slices from tomosynthesis are acceptable only in addition to the 2-view, full CC/MLO/ML mammograms
• Additional images (e.g., XCCL, spot views) may be submitted only in addition to the 2-view, full CC/MLO/ML mammograms
• Images must allow the ACR reviewers to determine if the physician can appropriately triangulate the lesion

All Sonogram Images

• Only submit the requested sonographic images. Do no submit additional images/frames. ACR reviewers will only evaluate the requested images.
• B mode images should be submitted
• Harmonic images, as well as compound spatial imaging are acceptable. Color Doppler images are not acceptable for accreditation.
• Split screen images are not acceptable for accreditation review. All ultrasound images must be full screen images.
• You may submit the same case for both the Breast Ultrasound Solid Mass and the Ultrasound-Guided Breast Biopsy Core Needle Biopsy exams. However, you must submit the images separately for each exam.
• All sonogram images must be taken from the same date of service.
• Transducers should operated at a center frequency of at least 12 MHz, and preferably higher. See Equipment: Breast Ultrasound for more information.
• Caliper measurements of the cyst or solid mass should be in its longest dimension; including both caliper measurements is acceptable.

Breast Ultrasound Module

• Simple Cyst:
  • The cyst must meet the BI-RADS® criteria for a simple cyst: a) anechoic, b) circumscribed margin, c) posterior enhancement, and d) round/oval
  • Complicated cysts, complex masses or dermal lesions are not acceptable for accreditation
  • The simple cyst submitted for accreditation should be over 0.5 cm in diameter

• Solid Mass:
  • Do not select an intramammary node or dermal lesion

Ultrasound-Guided Breast Biopsy Module (applies to the CNB and FNAC)

• Choose only BI-RADS® Category 4 or 5 cases to submit for accreditation review
• Images submitted for the ultrasound-guided breast biopsy module should demonstrate that physicians performing these procedures possess the skill necessary for appropriate needle positioning
• For all biopsies, the position of the needle relative to the solid mass must be easily appreciated on all biopsy images
• Pre-biopsy sonograms in 2 views (without calipers):
  • Submit 2 orthogonal sonographic images of the mass to be biopsies (e.g., if 1 image is in the transverse plane, the other should be in the sagittal plane). Submit only the requested sonographic images/frames.
  • Do not submit images with caliper measurements
• Transducer orientation: Each biopsy image must have a transducer orientation noted. The oblique orientation is acceptable only for images demonstrating the needle, if appropriate. The orthogonal pre-biopsy images cannot use the oblique label due to the inability to accurately label orthogonal planes from an oblique angle.
• Needle position: All biopsy images should demonstrate the entire needle (from its base to its tip) in its long axis, approximately parallel to the chest wall

Core Needle Biopsy (CNB):

• Fire Mode: 
  • Pre-fire (pre-biopsy): The needle tip is at the leading edge of the solid mass

• Post-fire (post-biopsy): The needle tip is through the solid mass

• Non-fire Mode:
  • Post-fire (post-biopsy): The needle tip is below or through the solid mass

Fine Needle Aspiration Cytology (FNAC):

• Solid masses only (no cyst aspirations or axillary lymph nodes)
• Post-fire (post-biopsy): The needle tip is below or through the solid mass 

Exam Identification and Labeling

Images are an important part of the medical record. One of the requirements for clinical images is correct labeling to include patient identification. The ACR understands that as providers, facilities are subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and that is why the ACR executes a HIPAA business associate agreement (BAA) with facilities. This agreement allows the collection of patient information in the performance of ACR accreditation activities which are specifically mentioned in the HIPAA regulations. If the facility has a BAA with ACR, they are covered under HIPAA. If not, contact the ACR to obtain an agreement for signature.

Each image should include the information below:

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