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Clinical Image Testing: Mammography (Revised 11-16-2022)

Revision History



Modular Approach to Mammography Accreditation

MQSA defines a Mammographic Modality as a “technology for radiography of the breast.” New mammographic modalities traditionally meant that a unit capable of two or more were treated as two separate units. For accreditation purposes, that is no longer the case. A unit that is capable of both FFDM and DBT imaging will be a single unit, with one testing package and one final report.

  1. Units that perform DBT and FFDM would apply as a single unit, with two modules. You will be required to submit

    1. Two Clinical images, a fatty case, and a dense case, 2D acquired or 2D synthesized images, as currently allowed.

    2. Phantom image:

      1. DBT module: Best slice tomosynthesis image, either in DICOM or non-DICOM format

      2. FFDM module: a 2D acquired image, in DICOM format

    3. All routine QC and the medical physicist report

    4. At least one interpreting physician, one technologist and one medical physicist must be qualified in the new modality.

  2. Units adding DBT to their existing accredited FFDM unit would apply mid-cycle, adding the DBT module onto the existing unit instead of adding a new unit. You’ll be required to submit

    1. Two Clinical images, a fatty case, and a dense case, 2D acquired or 2D synthesized images, as currently allowed.

    2. Phantom image: Best slice tomosynthesis image, either in DICOM or non-DICOM format

    3. All routine QC and the medical physicist report

    4. At least one interpreting physician, one technologist and one medical physicist must be qualified in the new modality.


For your convenience, the Clinical Image Review Sheet, Testing Packet Checklist, and Test Image Data Form are attached below.


Selecting Clinical Images 


For all submissions:

  1. All images for each 4-view exam must be from the same patient.

  2. Select cases consisting of CC and MLO images of both breasts.

  3. Only submit 4 images for each examination. 

  4. Only select cases where the entire breast can be imaged in a single exposure on each projection.

  5. Do not anonymize your images. Images must be labeled with the MQSA-required image identification information; ACR reviewers will evaluate this. All images must be labeled with MQSA-required image identification information, which can normally be found in the DICOM header. Information required for labeling must be available in the DICOM header of the image.

  6. Do not submit images that are performed on models or volunteers. Any image submitted must be of a patient who needed a mammogram, typically for screening reasons. The exam must have been formally interpreted, and the interpreting physician must have sent a report to the patient’s referring physician and a lay letter to the patient.

  7. Images from male patients may not be submitted. The ACR needs to evaluate images from patients that are typically examined by your facility, and the vast majority of mammography examinations are of women.

  8. There is no patient age limit for images submitted for accreditation review; however, images for accreditation review are typically chosen from patients recommended for screening mammography, and the ACR Practice Guideline for the Performance of Screening and Diagnostic Mammography states that screening mammography is indicated for asymptomatic women 40 years of age or older.

  9. The images must be of “final interpretation quality”.

  10. The lead interpreting physician must review and approve the clinical images.

  11. Images must be processed (marked “For Presentation”)


For initial, renewal, repeat or reinstatement accreditation:

  1. The clinical and phantom images from each unit must be taken within 30 days of each other, and from the current testing cycle (the date the testing packet was issued).

  2. One fatty case and one dense case

  3. BI‑RADS® Assessment Category 1, negative. If you cannot submit “negative” images (e.g., you do diagnostic exams only), call the ACR. If ACR reviewers determine that any submitted cases require additional evaluation or follow-up the Lead interpreting Physician must attest that they will review the findings and follow up with the patient as appropriate before a final accreditation report is issued.

  4. Select examples of your facility’s best work. The ACR reviewers will evaluate them accordingly. (See the “Clinical Image Evaluation” section of the 1999 ACR Mammography Quality Control Manual for the review criteria.)


For a validation cycle submission:

  1. The images must be from the date specified in the instruction email.

  2. This is a review of your facility’s everyday work.

  3. If available on the specified day, one fatty and one dense breast example.


If an ACR reviewer finds an abnormality, this will delay the facility’s accreditation. The FDA requires the accrediting body to return the images to the facility and the ACR requires the facility’s supervising radiologist to follow up as appropriate and return the completed Abnormality Follow-Up Attestation before the ACR will issue a final report. Failure to comply could result in a failure or deficiency for non-compliance. The ACR will randomly review facilities for compliance with this policy. We strongly suggest that all case review and any patient follow-up be documented. If an ACR reviewer finds an abnormality, the review of images is complete; therefore, it is not necessary to submit replacement images. 


In order for ACR Clinical Image Reviewers to assess your image quality for a range of breast types, you must submit one complete exam of fatty breasts and one complete exam of dense breasts for accreditation (initial, renewal, repeat or reinstatement cycles).


Fatty Breast Images

Must meet one of the two fatty BI-RADS Breast Composition Categories: “the breasts are almost entirely fatty” or there are scattered areas of fibroglandular density.” Images submitted should be at least as fatty as the example below.

Dense Breast Images

Must meet one of the two dense BI-RADS Breast Composition Categories: “the breasts are heterogeneously dense, which may obscure small masses” or “the breasts are extremely dense, which lowers the sensitivity of mammography.” Images submitted should be at least as dense as the example below.



If the ACR Reviewers do not believe that your images are of an appropriate density, we will return them to you and request another examination. If you are unable to find a case with dense or fatty breasts for submission, please contact the ACR for assistance.


At least 2 ACR radiologist reviewers will score 8 parameters on each case (for more information regarding review criteria, see the Clinical Image Evaluation section of the 1999 ACR Mammography Quality Control Manual):


A. Positioning

B. Compression

C. Exposure Level

D. Sharpness

E. Contrast

F. Noise

G. Artifacts

H. Exam Identification


When selecting your clinical images, please note these additional requirements:

  • Although not recommended, you may submit clinical images with a mole or nipple marker as long as the mole or nipple is clearly marked in a conventional manner.

  • Facilities may use lead laterality (L/R) markers during the exposure or may place computer generated markers on the image after the exposure using computer annotation. The College considers these methods equivalent. The same potential for error exists whether the computer or lead markers are used. It is the technologist’s responsibility to ensure that the annotation is correct.

  • The ACR realizes that not all artifacts can be eliminated (for example, it is rare to see a screen-film image with no dust artifacts); however, artifacts should not be so numerous or severe that they significantly degrade image quality.

  • Upload the DICOM images into your online Testing Package using TRIAD Windows Client or ACRedit Web Client.


Patient Identification and Labeling


Images are an important part of the medical record. One of the requirements for clinical images is correct labeling, including patient identification.


MQSA-Required Identification 

 (Applies to FDA-Approved Mammographic Modalities)

  • Name of patient (first and last)

  • Additional patient identifier (e.g., medical record number or social security number; date of birth is less desirable)

  • Date of examination

  • Standardized view (MLO, CC) and laterality (R/L) markers 

  • Facility name and location (must include city, state, and zip code)

  • Technologist identification, such as unique initials

  • Cassette/screen identification (usually an Arabic numeral written or pressed on the screen). This is used to identify screens with artifacts or defects.

  • Mammography unit identification number (usually a Roman numeral), if more than one unit in the facility.


The ACR also recommends the following identification on each image: 



Identification

Advantages/Discussion

Strongly Recommended

A patient ID system for hard copy

  • More permanent than stick-on labels

  • Information reproduces on copy films

  • ID should fit squarely in its designated space, near the edge of the film

  • Not acceptable if any information is illegible, does not fit, or is lopsided, causing cut-off of information

Recommended

Separate date stickers for hard copy

  • Allows for the date to be easily read with overhead light

  • May be color-coded by year to facilitate sorting of exams

Technical factors

Include target-filter combination, kVp, mAs, exposure time, compression force, compressed breast thickness and degree of obliquity




Revision History for this Article

Date

Section

Description of Revision(s)

12-12-19

All

Article created; FAQs incorporated; No criteria changes

11-09-2022Modular Approach to Mammography AccreditationNew section
11-16-2022Modular Approach to Mammography AccreditationClinical Image Review Sheet, Testing Packet Checklist, and Test Image Data Form attached



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