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Preparing and Submitting Your Accreditation Materials: Stereotactic Breast Biopsy (Revised 08-24-2023)

Revision History


As of March 26, 2020, accreditation submission defaulted to uploading images for Stereotactic Breast Biopsy accreditation.

Log into the online accreditation system and fill out all required clinical and phantom data forms, upload all required documents and submit the online testing package.

  • Medical Physicist Report for each unit

  • Daily, weekly technologist QC tests (one month worth of data)

  • Monthly, quarterly, semi-annual technologist QC tests (one year)

  • Clinical Exam Data Form

  • Phantom Exam Data Form


Ensure that all items below are complete before returning the submission to the ACR for accreditation review. The review process will not begin until your submission is complete. All items must be submitted for each unit being accredited (for your convenience, a standalone version of this checklist is available here):

  • Medical Physicist Report for each unit

  • Daily, weekly technologist QC tests (one month worth of data)

  • Monthly, quarterly, semi-annual technologist QC tests (one year)

  • Clinical Exam Data Form (one per unit) printed from the online testing package and appropriately labeled

  • Phantom Exam Data Form (one per unit) printed from the online testing package and appropriately labeled

  • Clinical images (appropriately labeled, if hard copy)

    • Mammogram images with the group of calcifications being evaluated circled

    • Specimen image

    • Pre-Fire OR Post-Fire stereo pair

  • Phantom images (appropriately labeled, if hard copy)

    • Phantom images must be on separate film from clinical images


Uploading Your Images

  1. Correlating Mammogram – Upload the two view mammogram in original DICOM format (required). This image must include ROIs of the calcifications being evaluated.

    1.  If you are unable to produce the images with the required ROIs in original DICOM format with all required labeling, you may also upload non-DICOM screen shots of the mammograms with the ROIs in addition to the DICOM images.

  2. Pre-Fire OR Post-Fire stereo pair in DICOM format

  3. Phantom image(s) in DICOM format (see phantom testing article for more information)

    1. For the Mini Digital Stereotactic Phantom, upload only one image.

    2. For the ACR Stereotactic Accreditation Phantom, you must upload four images in order to include the entire phantom.

  4. Once uploaded, check all images for adherence to accreditation criteria by clicking on "View" on the upload images page in your online testing package.


Submitting Your Images on Film

  • Go to your “My Testing Packages” link in your online account, and select Print Forms for Submission.

  • Print all clinical and phantom images on film or high quality photographic paper (as long as the paper image is of equal quality to a transparency). Only print and submit images on 10 X 12 inch films (or smaller). If you can only print on larger film, trim the film so that it is no larger than 10 X 12 inches. Films that are too large will be returned to the facility. CDs are not accepted.

  1. Print the image(s) as close to "true size" as possible (i.e. without magnification or minification)

  2. Do not print the phantom images on the same film that contains the clinical images

  3. For screen-film, process the image(s) using the processor normally used for your stereotactic clinical images


You may submit original mammograms or copies (as long as the copies clearly demonstrate the target calcifications). Mammogram copies must be good quality and clearly labeled with the patient ID and procedure date.


Clinical Image Labeling for Film Submission

For film submission, once you have printed your images and checked them for complete examination identification, attach the barcoded labels to the designated images as described below. Be sure that the labels do not cover any pertinent clinical or identification information on either the mammogram or the stereo images.


Please note that for your stereo pair images you are provided two Stereo Pair Image labels. Ensure you are labeling the images appropriately and use the label titled “Stereo Pair Image 2” if you are printing the stereo pair on two separate films.


Vacuum-Suction Biopsy Probe or Other FDA-Approved Core Biopsy Device: Image Labeling


Images

Labels

Required for All Submissions

2-view mammogram with the calcifications clearly circled*

  • Stereo correlating mammo image 1

  • Stereo correlating mammo image 2

Specimen radiograph

Specimen radiograph

Stereo Pair 


Pre-fire stereo pair demonstrating needle position

Stereo-pair image

OR

Post-fire stereo pair demonstrating needle position

Stereo-pair image



Gun-Needle Biopsy Probe: Image Labeling

Images

Labels

2-view mammogram with the calcifications clearly circled*

  • Stereo correlating mammo image 1

  • Stereo correlating mammo image 2

Specimen image

Specimen image

Pre-fire stereo pair demonstrating needle position

Stereo-pair image


*Clearly circle the calcifications to be biopsied on each mammographic projection. The case will fail if more than one group of calcifications is circled, or if the calcifications are not circled on all mammogram projections.


Stereotactic Phantom Image Labeling for Film Submission

Barcode identification labels must be affixed to the phantom image and the Phantom Exam Data form. These labels are for a specific unit and are marked “Phantom Image” and “Phantom Exam Data.” Be sure to put the appropriate label on the appropriate item. Place one phantom barcode label on each phantom image (i.e., if submitting the large phantom, submit four phantom images with the ACR Accreditation Phantom. Use phantom labels 1-4. If submitting one phantom image with the Mini Digital Stereotactic Phantom, only use phantom label 1.)


Mailing Instructions 

Send your materials to the following address:


Stereotactic Breast Biopsy Accreditation Program

American College of Radiology

1892 Preston White Drive

Reston, VA 20191-4397


Please note that your accreditation submission contains HIPAA data, so we strongly recommend that you send your submission via a traceable method with a signature required for delivery.


Your printed clinical and phantom images will be returned once the accreditation evaluation is complete. Submitted electronic images will be deleted from the ACR database after the accreditation process.9-19-2020


Please maintain copies of all documents and images submitted to the ACR and record the name of those patients whose clinical images were sent for accreditation until you receive official notification your accreditation was approved.



Revision History for this Article

Date

Section

Description of Revision(s)

12-12-19

All

Article created; FAQs incorporated; No criteria changes

9-19-2020

Introduction

Added information that submission defaults to uploading images 

9-19-2020

Uploading your images

Added bullet #4 instructing facilities to view uploaded images from inside the testing package before submission.

9-17-2021

All

Removed "pre-biopsy" and "preferred" from "pre-biopsy (post-fire)" device description. 

8-24-2023

Vacuum-Suction Biopsy Probe or Other FDA-Approved Core Biopsy Device: Image Labeling

Removed language about only submitting the pair indicated in the testing package.


ACR Mailing Address

Updated ACR Mailing Address to 1892.



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