Clinical Testing: Breast Ultrasound (Revised 01-16-20)
Modified on: Thu, 16 Jan, 2020 at 5:36 PM
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.
You may print Generic Test Image Data Forms 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. If submitting by film, print the exam data form(s) from the database and include with your images.
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 shred 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 labeling and sending 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 date by more than six months.
All images for each exam must be from the same patient.
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
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.
Includes the entire breast with the cyst/mass being evaluated circled on each image.
2D and 2D synthesized images from breast tomosynthesis are acceptable to submit; however, individual slices from tomosynthesis are acceptable only in addition to the CC/MLO views.
The cyst/mass being evaluated must be well visualized and clearly circled on both 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 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 reviewer to determine if the physician can appropriately triangulate the cyst/mass.
Do not use radiopaque markers.
The mammogram can be from an outside facility.
All Sonogram Images
Only submit the requested sonographic images.
Split screen images will be acceptable for electronic submissions.
Do not submit additional images/frames. ACR reviewers will only evaluate the requested images.
You may submit the same case for both the Breast Ultrasound Solid Mass and the Ultrasound Guided Breast Biopsy Core Needle Biopsy exams. To ensure that the exam is evaluated properly, you must submit the images separately for each examination.
Breast Ultrasound Module
Sonograms without calipers: Submit 2 orthogonal sonographic images of the cyst without calipers (e.g., if 1 image is in the transverse plane, the other should be in the sagittal plane).
Sonogram with calipers: Submit another sonographic image (of either plane) showing the appropriate caliper measurements of the cyst in its longest dimension.
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 not correspond to the radial or anti-radial scan planes.
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 or complex masses are not acceptable for accreditation.
Harmonic images, as well as compound spatial imaging are acceptable. Color Doppler images are not acceptable for accreditation. B mode images should be submitted.
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 CNB and FNAC)
Choose only BI-RADS® Category 4 or 5 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: For the CNB and FNAC (if applicable), 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.
Core Needle Biopsy (CNB)
Devices used in Fire Mode – (i.e. fired into the tissue sampling position)
Pre-fire 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-biopsy (post-fire) 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 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 sonogram: Submit a post-biopsy 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. A permanent sticker label is acceptable.
Patient’s first and last names (required)
Identification number and/or date of birth (required)
Examination date (required)
(Note: The ACR Breast Ultrasound Accreditation Program Requirements specify that 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 (required)
Transducer orientation (required) Note: Body markers will only be acceptable in conjunction with written transducer orientations.
Distance from the nipple to the abnormality measured in millimeters or centimeters (required)
(Note: You may indicate ‘retroareolar’ without a measurement if the abnormality is behind the nipple, no matter how deep.)
Sonographer’s and/or physician’s identification number, initials or other symbol
Revision History for this Article
Description of Revision(s)
Article created; FAQs incorporated; No criteria changes
|01-16-20||Simple cyst||Added: The simple cyst submitted for accreditation should be over 0.5 cm in diameter.|
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