Clinical Testing: Breast Ultrasound (Revised 10-21-2024)

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 apply 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 or 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 unit (if applicable) 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 on to 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 mass in the correlating mammogram

• Ability of the performing radiologist to appropriately triangulate the cyst or 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 destroy 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.

• 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.

• Do not submit male patients. 

• The area being evaluated or biopsied must be visible and easily appreciated on all submitted images:

  • Correlating mammogram (must be clearly circled)

  • All sonogram images

Correlating Mammogram

A 2-view mammogram (CC and MLO/ML/LM) of the breast being evaluated for each case.

• Performed within 60 days prior to the sonograms. Do not submit post-procedure images. 

• Includes the entire breast with the cyst/mass being evaluated circled on each image.

• A full-field 2D or 2D synthesized mammogram, in DICOM format.

• Individual slices from tomosynthesis are acceptable only in addition to the 2D and/or 2D synthesized CC/ML/MLO views.

• Additional images (i.e., XCCL or spot views) may be submitted in addition to, but not instead of, the 2-view mammogram.

• The cyst/mass being evaluated must be well visualized and clearly circled on both full-field mammographic views. If you do not circle the cyst/mass, you will fail accreditation because ACR reviewers will not be able to determine if the intended cyst or mass was imaged.

• Circling more than one lesion will also result in accreditation failure because ACR reviewers may be uncertain which cyst or mass is being evaluated or biopsied.

• Images must allow the ACR reviewers to determine if the physician can appropriately triangulate the cyst/mass.

• Do not use radiopaque markers in place of ROI (e.g., skin markers).

• The mammogram can be from an outside facility.

All Sonogram Images

• Only submit the requested sonographic images. Do not 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. 

• 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 examination.

• All sonogram images must be taken from the same date of service.

• Transducers must operate at a center frequency of at least 12 MHz, and preferably higher. See Equipment: Breast Ultrasound for more information. 

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.
  

• Sonograms without calipers: Submit 2 orthogonal sonographic images of the cyst or solid mass without calipers (e.g., if 1 image is in the radial plane, the other should be in the anti-radial plane).

  • Full screen images are required for the diagnostic images. 

• Sonogram with calipers: Submit another sonographic image (of either plane) showing the appropriate caliper measurement of the cyst or solid mass in its longest dimension. 

  • Split screen images are acceptable only for the images with caliper measurements. Transducer orientation is required on both sides of the split screen. Patient demographics, distance from nipple, etc. are acceptable on one side of the split screen. 

  • To make the caliper measurement, record the dimensions, to include the longest dimension. Submit one view in the scan plane demonstrating the longest dimension, which may not correspond to the two orthogonal views described in the previous item. This image must include the caliper measurement, as below:

Note that the scan plane of the lesion’s longest diameter may be in any plane.

Ultrasound-Guided Breast Biopsy Module (applies to 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 the pre-biopsy sonogram and on the images obtained during the biopsy.

• Pre-biopsy sonograms in 2 views (without calipers): Submit 2 orthogonal sonographic images of the mass to be biopsied (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.

  • Full screen images are required for the diagnostic images. 

Core Needle Biopsy (CNB)

• 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. 

• Devices used in Fire Mode – (i.e. fired into the tissue sampling position)

  • Pre-fire (pre-biopsy) sonogram with needle – demonstrating the needle aiming towards the mass just prior to insertion. The position of the needle should be in the long axis and approximately parallel to the chest wall.  

  • Post-biopsy (post-fire) sonogram: Submit a post-fire (post-biopsy) sonographic image (from the same mass) demonstrating the position of the needle in the long axis.  

• Devices used in Non-Fire Mode – (i.e., manually-advanced into the biopsy position)

  • Post-biopsy (post-fire) sonogram: demonstrating the long axis of the needle in the tissue acquiring position, either under or through the mass. 
    

Fine Needle Aspiration Cytology (FNAC) - Solid Mass Only (not cyst aspirations or axillary lymph nodes)

Post-biopsy (post-fire) sonogram: Submit a post-biopsy (post-fire) sonographic image (from the same mass) demonstrating the needle positioned clearly within the mass in the long axis.

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. If the required exam ID items are absent, the case will fail accreditation. 

• Patient’s first and last names (required)

• Identification number and/or date of birth (required)

• Examination date (required)

• Facility name

• Facility location - The “facility name and location” should be recorded on each image of the study. The location could be as basic as city and state; it does not need to be the full address. The ACR is aware of the problems that some units have with this, and consequently, will not fail a facility for this reason alone, as long as the other required labeling is present. However, ACR reviewers will recommend that location information be included on the images.

• Designation of right or left breast (required)

• Anatomic location of area being evaluated using text annotation (clock face notation) (required)

• Transducer orientation is required on all images, including each biopsy image and both split screen images, if used. Body markers will only be acceptable in conjunction with written transducer orientations.

• Distance from the nipple to the abnormality measured as "cm FN" (required) You may indicate ‘retroareolar’ without a measurement if the abnormality is behind the nipple, no matter how deep. A clock face notation is not required if the lesion is retroareolar. 

• Sonographer’s and/or physician’s identification number, initials or other symbol

• Biopsy images must be annotated or labeled (Pre-Fire, Post-Fire as described above) (required)

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