During accreditation review, at least two radiologist reviewers will assess the following case attributes:
Visualization of the calcifications in the pre-biopsy correlating mammogram
Appropriateness of the stereo pair
Appropriateness of the specimen radiograph
Examination identification of the correlating mammogram and stereo pair (The ACR will keep all patient information confidential)
Important Considerations When Selecting Clinical Cases
Facilities should select cases that represent their best work. The ACR Committee on Stereotactic Breast Biopsy Accreditation understands that all images obtained during all procedures may not meet these criteria. Consequently, the ACR allows sufficient time to select cases that are examples of “best work.” ACR reviewers will evaluate them accordingly.
Do not submit images that are obtained on models or volunteers.
Do not include any patient reports with your image submission. These reports will not be sent to 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.
Stereotactic biopsies performed with any FDA-approved core biopsy device may be submitted for accreditation. This may include a vacuum suction biopsy probe, gun-needle biopsy probe, or another FDA-approved core biopsy device. Lateral arm units are acceptable only if the lateral arm device is the only option for biopsy and the needle can be seen in relation to the calcifications in 2 views. Required images are detailed by device below.
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 (stereotactic breast biopsy and mammogram) submitted must be from the same patient.
Calcifications being biopsied must be visible and easily appreciated on all submitted images:
Mammogram images (calcifications to be biopsied must be clearly circled)
Stereo pair biopsy images
A 2-view mammogram (CC and MLO/ML/LM)
Performed within 60 days prior to the stereotactic procedure (Do not submit post-procedure images)
Includes the entire breast with the calcifications to be biopsied circled on each image
The mammogram can be from an outside facility
2D and 2D synthesized images are acceptable to submit, however, individual slices from tomosynthesis are acceptable only in addition to the CC/ML/MLO views
Additional images (i.e., XCCL, spot view or magnification views) may be submitted in addition to, but not instead of, the 2-view mammogram
The submitted images should demonstrate that physicians possess the skills necessary for appropriate needle positioning during these procedures.
Although valuable for some calcifications, “target-on-scout” images are not acceptable for accreditation because reviewers cannot assess the needle position on 2 views.
Vacuum-Suction biopsy probe (or other FDA-Approved Core Biopsy Device):
Pre-Fire stereo pair demonstrating needle positioning for tissue acquisition; the calcifications must be visible on both stereotactic views.
Post-fire stereo pair demonstrating needle positioning for tissue acquisition; the calcifications MUST be visible on both stereotactic views.
A Pre-Fire stereo pair demonstrating needle positioning; the calcifications must be visible on both stereotactic views.
A specimen image demonstrating calcium.
Facilities utilizing the Brevera specimen system should select the single specimen core with the most representative calcifications for accreditation submission. Do not submit multiple images.
Exam Identification and Labeling
Each image should be clearly and permanently labeled (a permanent sticker label is acceptable for film submissions) with the information below:
Patient’s first and last names (required)
Identification number and/or date of birth (required)
Examination date (required)
Facility location (city, state and zip)
Designation of left or right breast (required)
Annotation of mammographic view (e.g., CC, MLO/ML/LM)
Technologist’s identification number or initials
If the required items are absent on the correlating mammogram and stereo pair images, the case will fail accreditation.
|Previous: Testing Overview: Stereotactic Breast Biopsy||Next: Phantom Testing: Stereotactic Breast Biopsy|