Personnel Qualifications
Interpreting Physician Personnel Qualifications [1]
Must meet country’s qualification requirements
Must meet one of the following Continuing Experience requirements:
Radiologists
Read 200 breast ultrasound examinations in the prior 36 months (recommended)
Monitoring and evaluation indicating acceptable technical success, accuracy of interpretation and appropriateness of evaluation
Other physicians
Read 200 breast ultrasound examinations in the prior 36 months
Ultrasound-guided biopsies
36 image-guided breast biopsies in the prior 36 months
Meet one of the following Continuing Education requirements:
Radiologists
Currently meets the ABR Maintenance of Certification (MOC) requirements
150 hours CME (including 75 hours category 1) in the prior 36 months pertinent to the physician's practice patterns (see the ACR Practice Parameter for Continuing Medical Education).
Completes 15 hours CME (half must be Cat 1) in the prior 36 months specific to the imaging modality or organ system
Other physicians
15 hours CME (half must be Cat 1) in the prior 36 months in breast ultrasound, including biopsy
Only qualified physicians may independently perform ultrasound guided breast biopsy procedures. Physician Assistants or Radiologist's Assistants cannot perform without a qualified physician being in the room at the time of the biopsy procedure.
The physician performing or interpreting breast ultrasound exams or biopsies must:
Have a thorough understanding of the indications for breast ultrasound examinations
Be familiar with the basic physical principles and limitations of the technology of ultrasound imaging
Be familiar with alternative and complementary imaging and diagnostic procedures
Be capable of correlating the results of mammographic and other procedures with the sonographic findings
Have a thorough understanding of ultrasound technology and instrumentation, ultrasound power output, equipment calibration, and safety
Be able to demonstrate familiarity with breast anatomy, physiology, and pathology
Be familiar with interpretation and documentation in accordance with the ACR Practice Parameter for Communication of Diagnostic Imaging Findings
Technologist Personnel Qualifications
Must meet country's qualification requirements.
Have regular performance of breast ultrasound exams
Must have 24 hours of CE every 2 years
CE is relevant to imaging and the radiologic sciences, patient care
CE includes credits pertinent to the technologist's clinical practice
Ultrasound Equipment Quality Control (QC)
The committees on ultrasound and breast ultrasound accreditation understand that QC is a vital part of quality imaging and patient safety. Medical physicists and radiologist members of both committees decided on the tests and frequencies to be performed, as well as who is responsible for their performance.
The ACR strongly recommends that QC be done under the supervision of a qualified medical physicist (QMP). The QMP may be assisted by properly trained individuals in obtaining data, as well as other aspects of the program. These individuals should be approved by the QMP (if available, in the techniques of performing tests, the function and limitations of the imaging equipment and test instruments, the reasons for the tests, and the importance of the test results. The QMP should review, interpret, and approve all data. If it is not possible for a QMP to perform the tasks designated for a medical physicist, these tasks may be performed by other appropriately trained personnel with ultrasound imaging equipment experience. The ACR strongly recommends that the training be provided and documented by a QMP. If unable to acquire training by a QMP, training can be achieved through the ultrasound equipment manufacturer or through an appropriate course. These individuals must be approved by the physician(s) directing the clinical ultrasound practice.
Acceptance Testing
Initial performance testing of newly installed imaging equipment should be performed and should be completed before clinical use. This includes purchases of new scanners and/or transducers, as well as replacement equipment obtained under warranty or service contract. Acceptance testing should be done following equipment repair and may also be warranted following major equipment upgrade. Equipment pulled from storage should also undergo acceptance testing. This testing should be comprehensive and include all tests done for the annual survey (see below) to provide complete performance baselines for comparison with future test results.
While not required, there is value to be gained by a clinical practice in doing acceptance testing, if only to verify to the practice that the equipment will perform as expected when purchasing new imaging systems. It would provide a performance baseline for comparison against the annual survey. This will also establish the timeframe for subsequent annual surveys.
Annual Survey (Annual Systems Performance Evaluation)
Unless otherwise designated, the QC tests below are required and must be performed at least annually on all units and transducers in routine clinical use by the QMP or designee.
Either subjective visual methods or objective computer-based approaches may be used to make measurements [1]. If subjective methods are used, it is recommended that the images used to perform the tests be retained for comparison with subsequent test images. Tests of uniformity, geometric accuracy, system sensitivity, and contrast and spatial resolutions must be made using an ultrasound phantom or test object. The ACR does not specify the phantom(s) to be used. Phantoms may be obtained from a variety of commercial vendors or may be fabricated by experienced personnel. Other approaches to performance measurement, e.g., the “paper-clip test” [2] and use of transducer evaluation devices which test the electrical and acoustic characteristics of each individual transducer array element [3], may also be used, but may not replace any of the required tests. Additional information may be found in the ACR-AAPM Technical Standard for Diagnostic Medical Physics Performance Monitoring of Real Time Ultrasound Equipment.
Annual Survey (System Performance Evaluation) | |
QC Test | Description |
Physical and Mechanical Inspection | Assures the mechanical integrity of the equipment, and the safety of patient and operator. |
Image Uniformity and Artifact Survey | Identifies the presence of artifacts, often axial or lateral streaks in scans of uniform sections of a phantom. The use of “in-air” images (i.e., images acquired without the use of gel or phantom) may also be useful in detecting superficial artifacts; however, the potential limitations to the “in-air only” approach (e.g., limited sensitivity, especially for sector/vector probes) do not support use of in-air images only as a valid approach. In-air images could be used in this evaluation along with other assessment data, e.g., phantom images. |
Geometric Accuracy (Optional) | Commonly involves use of the scanner calipers to measure known distances between phantom test targets in the axial and lateral directions and also in the elevational direction for 3D probes. Other tests of geometric accuracy are acceptable, e.g. verifying accuracy of the pixel size calibration in the image header. |
System Sensitivity | Methods relying on visual determination of the maximum depth of visualization of speckle patterns or phantom targets, and quantitative measurements of signal-to-noise ratio (SNR), have been reported. |
Ultrasound Scanner Electronic Image Display Performance | Maintaining the performance of the image display is critical for providing the greatest diagnostic benefit of the scanner. Display characteristics that are evaluated may include gray scale response and luminance calibration, presence of pixel defects, and overall image quality. These evaluations are typically performed using specialized test pattern images, and may also require photometric equipment. See ACR-AAPM-SIIM Technical Standard for Electronic Practice of Medical Imaging. |
Primary Interpretation Display Performance (Optional) | Primary diagnostic displays may be electronic soft-copy displays on a PACS workstation or hard-copy films. They should also include worklist monitors only if used for primary interpretation (other than color analysis). Display characteristics that are evaluated may include gray scale response and luminance calibration, presence of pixel defects, and overall image quality. These evaluations are typically performed using specialized test pattern images, and may also require photometric equipment. See ACR-AAPM-SIIM Technical Standard for Electronic Practice of Medical Imaging for additional information on tests and testing methods. |
Contrast Resolution (Optional) | The use of both anechoic and low contrast echogenic targets has been suggested, as has the use of 2D cylindrical targets and 3D spherical targets. |
Spatial Resolution (Optional) | Should be measured in the axial, lateral, and elevational directions. Various approaches have been described for these measurements via visual interpretation of groups of phantom pin/fiber targets and using computer-based algorithms to measure pin dimensions(1-4). |
Evaluation of QC Program (if applicable) | Provides an independent assessment of the QC program, checks that appropriate actions are taken to correct problems, identifies areas where quality and QC testing may be improved, and enables a comparison of QC practices with those of other ultrasound sites. |
References
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If the annual survey test results fall outside of the acceptable limits, corrective action must be taken. Appropriate action must occur immediately if there is imminent danger to patients or staff using the equipment due to unsafe conditions. However, for other cases there is no specific timeframe required by the ACR. You should consult your medical physicist/service person regarding the seriousness of the failure to determine how quickly corrective action should be implemented. The ACR will not grant recognition if documentation of compliance with ACR QC requirements is not provided; if any tests fail, you must provide documentation of corrective action with your QC materials.
Quality Control Tests
A continuous QC program is essential to assure the proper functioning of all ultrasound equipment and to identify problems before the diagnostic utility of the equipment is significantly impacted [7-8]. Routine QC tests are outlined in the table below and unless otherwise noted, should be conducted semiannually, at minimum. Routine QC is typically performed by appropriately trained sonographers or equipment service engineers. The lead sonographer is not required to conduct routine QC, and you do not need to notify ACR of the designated staff performing QC. At this time, the ACR does not provide forms to record data from routine QC tests. We suggest working with your qualified medical physicist to help develop your own forms or contacting the equipment manufacturer.
If any test results (acceptance tests, annual survey, QC) fall outside of the acceptable limits, corrective action must be taken. This is typically accomplished by an equipment service engineer. Appropriate action and notification must occur immediately if there is imminent danger to patients or staff using the equipment due to unsafe conditions. After a problem has been addressed, acceptance testing should be performed to assure adequate resolution of the problem, and these test results should be documented.
Routine QC | |
QC Test | Description |
Physical and Mechanical Inspection | Assures the mechanical integrity of the equipment, and the safety of patient and operator. |
Image Uniformity and Artifact Survey | Identifies the presence of artifacts, often axial or lateral streaks in scans of uniform sections of a phantom. The use of “in-air” images (i.e., images acquired without the use of gel or phantom) may also be useful in detecting superficial artifacts (an in-air only approach to uniformity assessment for the routine QC test is reasonable and acceptable; a good implementation would provide baseline images of the reverberation/interference pattern for comparison to aid in detecting potential uniformity problems). All transducer ports on each scanner should be tested using at least 1 transducer. In the case of single probe, it is likely left plugged into the same port all the time, and other ports are not used. In this case, not testing the other ports would be acceptable for accreditation purposes. |
Geometric Accuracy (Mechanically scanned transducers only) | Commonly involves use of the scanner calipers to measure known distances between test targets. Measurement is required only in the mechanically scanned directions. |
Ultrasound Scanner Electronic Image Display Performance | Maintaining the performance of the image display is critical for providing the greatest diagnostic benefit of the scanner. They should also include worklist monitors only if used for primary interpretation (other than color analysis). Display characteristics that are evaluated may include gray scale response, presence of pixel defects, and overall image quality. These evaluations are typically performed using specialized test pattern images. See ACR-AAPM-SIIM Technical Standard for Electronic Practice of Medical Imaging for additional information on tests and testing methods. |
Primary Interpretation Display Performance | This test should be performed semiannually, or as judged appropriate based on the specific display technology, or prior QC testing data. Primary diagnostic displays may be electronic soft-copy displays on a PACS workstation or hard-copy films. Display characteristics that are evaluated may include gray scale response and luminance calibration, presence of pixel defects, and overall image quality. These evaluations are typically performed using specialized test pattern images and may also require photometric equipment. See ACR-AAPM-SIIM Technical Standard for Electronic Practice of Medical Imaging for additional information on tests and testing methods. |
References7. Mårtensson M, Olsson M, Brodin LÅ. Ultrasound transducer function: annual testing is not sufficient. Eur J Echocardiogr. 2010 Oct; 11(9): 801-5.8. Hangiandreou NJ, Stekel SF, Tradup DJ, Gorny KR, King DM. Four-year experience with a clinical ultrasound quality control program. Ultrasound Med Biol. 2011 Aug; 37(8): 1350-7. | |
Preventative Maintenace
Regular preventive maintenance should be performed and documented by a qualified equipment service engineer following the recommendations of the equipment vendor.
References
1. Goodsitt MM, Carson PL, Witt S, Hykes DL, Kofler JM, Jr. Real-time B-mode ultrasound quality control test procedures. Report of AAPM Ultrasound Task Group No. 1. Med Phys 1998; 25: 1385-1406.
2. Goldstein A, Ranney D, McLeary RD. Linear array test tool. J Ultrasound Med 1989; 8: 385-397.
3. Moore GW, Gessert A, Schafer M. The need for evidence-based quality assurance in the modern ultrasound clinical laboratory. Ultrasound 2005; 13: 158-162.
4. Gibson NM, Dudley NJ, Griffith K. A computerised quality control testing system for B-mode ultrasound. Ultrasound Med Biol 2001; 27:1697-1711.
5. Thijssen JM, Weijers G, de Korte CL. Objective performance testing and quality assurance of medical ultrasound equipment. Ultrasound Med Biol 2007; 33: 460-471.
6. Skolnick ML. Estimation of ultrasound beam width in the elevation (section thickness) plane. Radiology 1991; 180: 286-288.
7. Mårtensson M, Olsson M, Brodin LÅ. Ultrasound transducer function: annual testing is not sufficient. Eur J Echocardiogr. 2010 Oct; 11(9): 801-5.
8. Hangiandreou NJ, Stekel SF, Tradup DJ, Gorny KR, King DM. Four-year experience with a clinical ultrasound quality control program. Ultrasound Med Biol. 2011 Aug; 37(8): 1350-7.
Clinical Image Evaluation and Labeling
Facility’s must review 1 typical clinical examination from each module performed and attest to meeting the ACR clinical image quality and labeling requirements found in the links below.
Exam Requirements
Facilities must review all services provided. For example, if no biopsies are conducted, the facility should only review 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 review both.
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 review.
The simple cyst submitted for accreditation should be over 0.5 cm in diameter.
Solid Mass: Do not review an intramammary node or dermal lesion.
Sonograms without calipers: Review 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: Review 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. Review one view in the scan plane demonstrating the longest dimension, which may not correspond to the two orthogonal views described in the previous item.
Ultrasound-Guided Breast Biopsy Module (applies to CNB and FNAC)
Choose only BI-RADS®- Category 4 or 5 to review.
Images reviewed 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): Review 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).
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: 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
Review a post-biopsy (post-fire) sonographic image (from the same mass) demonstrating the needle positioned clearly within the mass in the long axis.
A 2-view mammogram (CC and MLO/ML/LM) of the breast should also be 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.
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 reviewed 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.
Do not use radiopaque markers in place of ROI (e.g., skin markers).
The mammogram can be from an outside facility.
Exam Identification and Labeling
Imaging labeling - organ/anatomy of interest, transducer orientation plane, side (if applicable), vessel segment (i.e., proximal, mid, distal if applicable)
Each image should include the information below.
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 region; it does not need to be the full address.
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)
Physician Quality Assurance
Facilities must meet the Physician Quality Assurance requirements found in Physician QA Requirements: CT, MRI, Nuclear Medicine/PET, Ultrasound (Revised 1-3-2024): Accreditation Support (acr.org).
Outcome Data – Ultrasound-Guided Breast Biopsy Accreditation Module Only
Each facility performing the Ultrasound-Guided Breast Biopsy Module must document outcome data. The minimum data elements to be collected are:
Total number of procedures
Total number of cancers found
Total number of benign lesions
Total number of ultrasound-guided biopsies needing repeat biopsy, categorized by reason and type of biopsy (i.e., CNB, FNAC):
Insufficient Sample
Total number of cases
Number with repeat biopsy performed by core
Number with repeat biopsy performed by excision
Discordance with Imaging
Total number of cases
Number with repeat biopsy performed by core<
Number with repeat biopsy performed by excision
Cellular Atypia, Radial Scar
Total number of cellular atypia cases
Total number of radial scar cases (CNB only)
Number with repeat biopsy performed by core
Number with repeat biopsy performed by excision
Other
Total number of cases
Number with repeat biopsy performed by core
Number with repeat biopsy performed by excision
Complications categorized by type of biopsy (i.e., CNB, FNAC)
Total number
Number with hematoma (requiring intervention)
Number with infection
Number with pneumothorax (CNB only)
The ACR strongly recommends that the biopsy report include a statement referring to the pathology results, imaging/pathologic concordance, and follow-up recommendations based on pathology results.
Footnotes:
[1] Occasional readers who are providing imaging services to and for the practice readers are not required to meet continuing experience requirements. However, the reads of all occasional readers combined should not exceed 5% of the total volume of reads per practice and per modality. There must be an active written review process in place at the institution for occasional readers based on each institution’s credentialing requirements.