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• Breast Ultrasound Accreditation Program Update
• Application - General
• Moved Facilities and Units
• Equipment
• Personnel
• Accreditation Testing
• Quality Assurance and Quality Control

(Updated: January 26, 2010)

Breast Ultrasound Accreditation Program Update

Q.   How many breast ultrasound facilities are accredited by the ACR?
A.   As of October 1, 2009, 1014 breast ultrasound facilities were accredited by the ACR.

Q.   What is the current pass rate for units applying for accreditation in breast ultrasound?
A.   In 2009, the first-attempt pass rate for new or renewing units was 80%. Almost all of the facilities passed on their second attempt at accreditation (after taking appropriate corrective action to improve quality).

Q.   We only perform breast ultrasound and ultrasound-guided breast biopsies at our facility (no mammography). Must we be certified under MQSA?
A.   No. Currently, MQSA only applies to x-ray imaging of the breast. Since ultrasound does not utilize x-rays to create the image, it is not covered by MQSA.

Application - General

Q.   I have questions about my facility’s accreditation. Where can I go for help?
A.   With just a click of the mouse you have 24/7, user-friendly access to the complete array of the ACR’s highly respected accreditation programs, from easy-to-use application, testing and quality control forms for each modality, to a list of the most frequently asked questions. Visit www.acr.org/accreditation today! If our on-line information does not address your specific question, please call us using the Diagnostic Modality Accreditation Information Line at 800-770-0145. Our phone lines are open business days from 8:30 AM – 5PM eastern time.

Q.   How long does the accreditation process take?
A.   If you submit all of the requested information within ACR deadlines, the process typically takes 4 to 6 months.

Q.   Do facilities undergo a site survey as part of the accreditation process?
A.   No. The accreditation process is conducted primarily by mail. The ACR may perform random site visits with prior notification to validate maintenance of accreditation criteria.

Q.   Our facility is currently accredited by the ACR. When should we expect to be notified that it is time to renew?
A.   The ACR will notify your Modality-Specific Supervising Physician about renewal approximately 8 months prior to your ACR accreditation certificate expiration. If you do not hear from us, please call our office so we may follow up on this for you.

Q.   Will the ACR accept faxed signatures for the application?
A.   Yes, the ACR does accept faxed signatures. These will be treated as legally binding.

Q.   Will the ACR accept electronic or digital signatures for accreditation applications?
A.   Yes, the ACR does accept electronic or digital signatures. These will be treated as legally binding.

Q.   How long do I have to submit Initial or Renewal testing materials to the ACR?
A.   You have 45 calendar days from the date the testing materials are sent to complete and return them to the ACR. (The due date is printed on the labels.) If you have problems meeting this deadline, call the Diagnostic Modality Accreditation Information Line at 800-770-0145 for help.

Q.   We are close to the testing material deadline and have not been able to find appropriate images to submit. May we have an extension to this deadline?
A.   Please call the Diagnostic Modality Accreditation Information Line at 800-770-0145 for guidance.

Q.   We submitted our testing materials 3 weeks ago. When will we get our results?
A.   The accreditation review process takes approximately 3 to 4 months from the time the ACR receives your testing materials. You should receive your results soon after that.

Q.   Can the ACR provide my assistant with our accreditation results over the phone or by fax?
A.   No. Because the ACR’s Accreditation Programs are peer-review processes, the information we receive or develop during accreditation is considered privileged and confidential. We will provide the results of your accreditation to your Modality-Specific Supervising Physician by mail as soon as the review is complete.

Q.   What happens if we do not pass accreditation on our first attempt?
A.   You will have to repeat only the categories that are deficient; you will not have to repeat the entire process. For example, if you received a deficiency in the Core Needle Biopsy category, you would need to take corrective action and submit a new Core Needle Biopsy case; if you received a deficiency in the Breast Ultrasound category, you would have to take corrective action and submit both a new simple cyst case and a solid mass case.

Q.   My facility did not pass accreditation. May we appeal the decision? If so, what’s involved?
A.   Yes. Facilities that receive a deficiency or a failure may appeal the determination in writing within 15 days of the date of the final report. You must send the original images for all of the submitted cases in the category that did not pass along with a letter describing your reason for appealing. Only those images reviewed for the original determination (and having the original labels) will be considered during the appeal evaluation. These will be forwarded to an arbitrator (a reviewer who did not participate in the initial review) with a copy of the previous reviews and the appeal letter written by the facility. No other images will be sent to the reviewer for consideration in the evaluation. The arbitrator’s determination will be final.

Q.   We recently appealed an adverse accreditation decision. When should we receive the results of the appeal?
A.   You should receive the appeal results within 30 to 45 days of the date all required appeal materials were received by the ACR.

Q.   We did not pass accreditation because our technologists selected and submitted the wrong images. May we appeal the decision and submit new cases?
A.   Although you may appeal the decision, you may not submit new cases. During accreditation review, the ACR reviewers assume that the submitted cases were reviewed by the modality’s supervising physician (as specified in the Testing Instructions) and are examples of your best work. Consequently, during an appeal, you may only submit the original images with the original ACR labels.

Q.   We did not pass accreditation because our technologist did not submit all required images and provided insufficient information with the images that were submitted. May we appeal the decision and submit the rest of the required information?
A.   You may appeal the decision; however, you may only submit the original images with the original ACR labels. Please call the Diagnostic Modality Accreditation Information Line at 800-770-0145 for further guidance on your specific situation.

Q.   How may we add a module (Core Needle Biopsy or Fine Needle Aspiration Cystology) to our existing accreditation?
A.   If you have more than 13 months left on your modality’s accreditation certificate, you will need to send a letter signed by the lead interpreting physician requesting to add a module. If you have more than 13 months on your accreditation, the fee for adding a module is $500. If you have 13 months or less, you will need to start the renewal process early. Please contact the Diagnostic Modality Accreditation Information Line at 800-770-0145 for further information.

Moved Facilities and Units

Q.   We will be moving our breast ultrasound unit to a new room. Do I need to provide any information to the ACR?
A.   No. If you are only moving the breast ultrasound unit to a different room within the same facility, you do not have to notify the ACR. However, if your entire facility is moving to a new location, please provide the ACR your new address (as well as any other pertinent changes, such as the Practice Site and/or Modality-Specific Supervising Physician or contact) so that you will be appropriately notified when it is time to renew your accreditation.

Q.   We will be moving our breast ultrasound facility to a new address. Do I need to provide any information to the ACR?
A.   Yes. If your entire facility is moving to a new location, please provide the ACR your new address (as well as any other pertinent changes, such as the Practice Site and/or Modality-Specific Supervising Physician or contact) so that you will be appropriately notified when it is time to renew your accreditation.

Equipment

Q.   We have just installed a new 3-D automated whole breast ultrasound system. May I submit images from this unit for accreditation? If I am already accredited in breast ultrasound with the ACR, will this negatively influence my accreditation status?
A.   No. The ACR Breast Ultrasound Accreditation Program does not accept images from 3-D whole breast ultrasound systems. However, adding this type of ultrasound unit would NOT jeopardize your accreditation as long as your facility maintains a conventional hand-held ultrasound system to maintain your accreditation and accredits upon renewal. In addition, all individuals who meet our breast ultrasound accreditation requirements must operate all ultrasound equipment (including the 3-D system). If an ACR-breast ultrasound accredited facility uses unqualified operators, we could revoke their accreditation.

Q.   What exactly is the “center frequency”? The program requirements state that breast ultrasound procedures must be performed on appropriately equipped ultrasound units operating at a center frequency of at least 10 MHz and preferably, higher.
A.   The center frequency is usually the frequency designated on the transducer. Because each ultrasound system is different, you should contact the manufacturer of the ultrasound equipment if you have any questions.

Personnel

Q.   I have attended several breast conferences that included ultrasound-guided breast biopsy lectures, but the CME certificate does not break out the specific number of hours pertaining to the ultrasound-guided component. How do I document that I meet the initial requirements for CME?
A.   If you have the syllabus from the meeting, or have the schedule of the lectures for the meeting, you can attach it to the CME certificate. If you do not have this information, document how much time was spent on the subject and attach it as a note to the CME certificate.

Q.   In order to obtain continuing education credit for breast ultrasound and ultrasound-guided biopsy must the coursework be specifically designed for breast ultrasound and ultrasound-guided biopsy?
A.   No. Many general or breast continuing education activities include topics relevant to breast ultrasound and ultrasound-guided biopsy. The following are just a few examples

• Breast imaging conference that included discussion of breast ultrasound and ultrasound-guided biopsy
• Breast tumor board meeting that include cases undergoing breast ultrasound and ultrasound-guided biopsy
• Quality control seminars that include topics on processor or laser printer quality control or phantom image evaluation

You are responsible for documenting your own continuing education in breast ultrasound and ultrasound-guided biopsy. This can be done by documenting how much time was spent on the breast ultrasound and ultrasound-guided biopsy related subject and attaching the note to the syllabus or CME certificate.

Q.   We heard that the ACR is requiring physicians working in breast ultrasound to have 5 continuing education credits in breast ultrasound? Is this true? If so, is this requirement per year or per 3-year renewal?
A.   Starting July 1, 2007, the ACR Accreditation Programs implemented new continuing education requirements for physicians and medical physicists practicing in non-breast imaging modalities (i.e., CT, MRI, ultrasound, nuclear medicine, and PET). The vast majority of physicians performing breast ultrasound are qualified under MQSA to interpret mammograms, and MQSA already imposes stringent requirements for continuing education (15 CME every 3 years) that allow physicians to include credits in breast ultrasound. Because of this, the new ACR requirements will not apply to the breast imaging accreditation programs. (See the article on New Accreditation Requirements for details on the non-breast imaging requirements.)

The ACR Accreditation Programs do recommend that qualified physicians follow the ACR Practice Guideline for Continuing Medical Education (a minimum of 150 hours in Categories 1 and 2 every 3 years with at least 75 of these hours in Category 1). The CME should include credits in breast ultrasound appropriate to the physician’s practice needs. (For diagnostic radiology, the guideline recommends that at least 70% be specialty-specific.)

For accreditation in the Ultrasound-Guided Breast Biopsy Module, the ACR requires physicians to have 3 hours of Category 1 CME in ultrasound-guided breast biopsy every 3 years. (These also may be counted towards the MQSA CME requirements.)

See the Breast Ultrasound Program Requirements for details on personnel requirements.

Q.   Does the ACR require all physicians working in breast ultrasound to obtain 150 hours of CME?
A.   No. The ACR Accreditation Programs recommend that qualified physicians follow the ACR Practice Guideline for Continuing Medical Education (a minimum of 150 hours in Categories 1 and 2 every 3 years with at least 75 of these hours in Category 1). The CME should include credits in breast ultrasound appropriate to the physician’s practice needs. (For diagnostic radiology, the guideline recommends that at least 70% be specialty specific.)

Q.   The application materials ask for the names of our “Practice Site Supervising Physician” and the “Modality-Specific Supervising Physician” in another section. Are they the same person?
A.   Depending on your particular facility’s management structure, these may be the same person but do not have to be:

• The Modality-Specific Supervising Physician is responsible for the individual modality (e.g., breast ultrasound) at your practice site. This physician must oversee the clinical exam selection for accreditation and review all testing materials relating to that modality only before they are sent to the ACR.
• The Practice Site Supervising Physician has overall responsibility for the entire practice site location (e.g., breast ultrasound, ultrasound, stereotactic breast biopsy, whatever your facility is accredited in with the ACR). This physician ensures that all terms stated in the Practice Site Accreditation Survey Agreement are met.

Q.   Our Practice Site Supervising Physician just left. Do we need to designate a new one and report this to the ACR?
A.   Yes. Your new Practice Site Supervising Physician and the Practice Site Officer or Owner must read and sign the conditions for accreditation in the Practice Site Accreditation Survey Agreement. You may download this from the ACR website.

Q.   Our hospital is accredited with the ACR in both Breast Ultrasound and Ultrasound-Guided Breast Biopsy. The breast ultrasound practice is currently supervised by our radiology group. We recently discovered that the surgeons in our hospital are buying their own ultrasound unit for breast imaging. Since they are located in the same hospital, do they need to meet the ACR accreditation requirements and fall under our facility’s Practice Site Supervising Physician’s responsibilities in order for our facility to maintain our accreditation? If they do not, will our accreditation be in jeopardy?
A.   Please contact the ACR Diagnostic Modality Accreditation Information Line at 800-770-0145 for individual assistance. The answer to this question depends greatly on the specific arrangements of your facility’s practice.

Q.   May our Physician’s Assistant independently perform ultrasound-guided biopsy procedures at our accredited facility?
A.   No. Only qualified physicians may independently perform ultrasound-guided biopsy procedures at facilities accredited by the ACR.

Q.   May our Radiologist’s Assistant independently perform ultrasound-guided biopsy procedures at our accredited facility?
A.   No. Only qualified physicians may independently perform ultrasound-guided biopsy procedures at facilities accredited by the ACR.

Q.   The technologists at our facility do not perform the breast ultrasound examinations. The radiologists do. Our mammography technologists only assist the radiologists by setting up the room. Must the technologists meet the “Sonographer or Mammography Technologist Qualifications” specified by the ACR in order for us to be accredited in breast ultrasound?
A.   No. As long as your radiologists are qualified and the technologists are not performing the ultrasound exams, the technologists assisting the radiologists do not need to meet the accreditation program’s qualifications for technologists.

Q. Does the ACR have continuing education requirements for technologists performing breast ultrasound?
A.   Indirectly, yes. Although the Breast Ultrasound Accreditation Program has no specific continuing education requirements for technologists, the ACR does require that technologists be certified by either ARDMS or ARRT (or hold an unrestricted state license). All of these organizations have continuing education requirements to maintain certification/licensure.

Q.   Must all technologists performing breast ultrasound procedures have ARDMS or ARRT (sonography) certification?
A.   No. Technologists performing breast ultrasound who do not have ARDMS certification or ARRT breast sonography certification must be MQSA-qualified (with current ARRT certification and registration, or an unrestricted state license). A physician is not required to be present during breast ultrasound examinations performed by ARDMS sonographers or ARRT technologists with certification in breast sonography; however, a physician must be in the department during examinations performed by ARRT technologists without an advanced registry in breast sonography.

Q.   Does the technologist need to be ARDMS-certified in order for a facility to apply for the Ultrasound-Guided Breast Biopsy Module?
A.   No. This program is designed to evaluate the physician’s skills. The physician must perform the biopsy, not the technologist.

Q.   Are technologists performing breast ultrasound examinations required to have training specific to breast ultrasound?
A.   Yes. In order to meet the ACR initial qualifications, technologists performing breast ultrasound exams must have at least 5 continuing education units (CEUs) of breast ultrasound topics. After they meet these initial qualifications, they must continue with the continuing education as required by the certifying organization (i.e., ARRT, ARDMS).

Q.   Are we required to submit proof of certification and/or continuing education as part of our facility’s application for breast ultrasound accreditation?
A.   No. You should keep all documentation verifying that your personnel meet accreditation requirements on file at your facility. The information should be available upon request.

Accreditation Testing

Q.   Do we have to submit clinical images from all the units listed on the application?
A.   No. The ACR Breast Ultrasound Accreditation Program is facility-based. Only one set of images per type (i.e., simple cyst, solid mass, CNB, FNAC) is required regardless of the number of breast ultrasound units or the number of physicians at the facility.

Q.   May we submit clinical images on paper?
A.   Images should be submitted on standard transparency film; however, the ACR will accept images on photographic paper as long as they are of good quality.

Q.   May I submit my images on CD instead of printing them?
A.   No, not at this time.

Q.   Can the breast ultrasound images be from a volunteer if a patient is not available?
A.   No. All clinical images must come from patient examinations. In addition, all views of a breast ultrasound examination must be from an examination performed on the same patient.

Q.   How far back can I go to select my images to submit for accreditation?
A.   A facility may select cases for accreditation review as far back as 3 months prior to the stamped application date.

Q.   I have a good ultrasound case from this week to submit for accreditation; however, the patient’s mammogram was performed 3 months ago. Is this acceptable for accreditation?
A.   No. The sonograms and mammograms submitted for accreditation must be from the same 60-day period to enable the ACR reviewers to accurately correlate between the lesion evaluated by the ultrasound exam and the lesion on the mammogram.

Q.   Are we required to submit original mammograms with the breast ultrasound images for accreditation?
A.   No. Copies of mammograms will be accepted as long as they are of good quality and clearly labeled with the patient identification and the date of the procedure.

Q.   We would like to submit hardcopies of digital mammograms with our breast ultrasound cases. May we print all 4 views on 1 sheet of 8x10 film?
A.   No. The breast images on the mammograms must be as close to "true size" as possible (i.e., without magnification or minification). If you minify the images to fit them all on 8x10 film, the ACR reviewers will not be able to correlate the size of the cyst or mass on the ultrasound with the one on the ultrasound image. You may fail accreditation as a result.

Q.   May the mammograms come from an outside facility?
A.   Yes. The mammograms submitted may be copies of mammograms from another facility as long as they are of good quality. They do not have to be from the facility undergoing breast ultrasound accreditation.

Q.   The cyst/mass is not visible on the mammogram. Do I still need to submit the mammogram?
A.   The cyst/mass must be visible on both mammographic views. Please submit another case.

Q.   I would like to submit a case where the cyst/mass is only visible on the 2-view spot compression mammograms. It is not visible on the routine CC and MLO views. May I submit only the spot compression mammograms?
A.   Yes. Projections such as compression spots or magnification views are acceptable as long as they demonstrate the cyst/mass in 2 planes, and the cyst/mass has been clearly marked.

Q.   The manufacturer of our breast ultrasound unit tells us they are unable to include our facility’s full address on the image for technical reasons. Will we fail accreditation without this information on each image?
A.   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.

Q.   Does the patient ID have to be on each image/frame on each sheet of film?
A.   Yes.

Q.   Do we need to submit the patient’s ultrasound report with the images that we are submitting for accreditation?
A.   No. The Breast Ultrasound Accreditation Program does not request you to submit the patient’s report with the images.

Q.   Our facility performs a very low volume of fine needle aspirations and core needle biopsies. Do we still need to accredit these tests with the ACR?
A.   Yes. If both Core Needle Biopsies (CNB) and Fine Needle Aspiration Cytology (FNAC) are performed, the facility must also apply for the Ultrasound Guided Breast Biopsy module, and submit both types of cases.

Q.   Our facility uses needles to aspirate cysts. Is this fine needle aspiration cytology (FNAC)?
A.   No. FNAC involves the collection of tissue from a solid mass. Cyst aspirations are not FNAC. Do not submit cyst aspiration images for FNAC.

Q.   Our facility only does fine needle aspiration on lymph nodes. May we submit these images for the FNAC in the Ultrasound-Guided Breast Biopsy Module?
A.   Yes, as long as you can also provide corresponding mammograms with the biopsied lymph node clearly visible (and marked) on both mammographic views.

Q.   The testing package contains a large number of sticky labels. Must I use all of them?
A.   No. Use only the labels that pertain to the cases you are submitting for accreditation review. You may discard the unused labels. Please refer to the “Labeling Guide” in the Testing Instructions.

Q.   The testing package contains sticky labels for the images. What am I supposed to do with them? (We are applying for breast ultrasound and core needle biopsy – vacuum suction accreditation.)
A.   ACR clinical image reviewers must evaluate the quality and appropriateness of a large number of ultrasound images from a large number of breast ultrasound facilities. The reviewers want to know that facility personnel understand the type of each image requested. The sticky labels allow you to clearly indicate to the reviewers the types of images you have submitted for review.

Please print each case on a separate film. (CDs are not accepted at this time.) Be sure to provide only the requested images, and place the appropriate sticky label below its corresponding image. Draw an arrow on the label pointing at the image to which it refers. If the images are not labeled correctly, the reviewers will fail your case because the image will not meet the ACR criteria for the type of image requested. Please refer to the “Labeling Guide” in the Testing Instructions.

In your specific case, you will need the following labels:

You should submit 3 ultrasound films with the label below the specific image to be evaluated:

Q.   Can we only use one of the Sono labels provided in the testing package? 
A.   No. Please use both Sono labels that are provided to you with your breast ultrasound testing materials. The Breast Ultrasound Accreditation Program requires you to clearly label the images that you would like the reviewers to evaluate.

Q.   We received barcode labels for FNAC but we do not perform this exam. Should we just ignore these labels?
A.   No. ACR only sends FNAC labels if the application indicated that the site performs that exam. If your site does not perform FNAC then you must notify the ACR of this correction in writing, signed by the Supervising Physician. This letter may be faxed to (703) 648-9176, ATTN: BUAP.

Q.   May I submit the same case for both the Breast Ultrasound solid mass and the Ultrasound-Guided Breast Biopsy core needle biopsy exams?
A.   Yes. But to ensure that the exam is evaluated properly, you must print only the requested images for the solid mass on 1 film and the requested images for the core needle biopsy on a separate film. Be sure to label them appropriately (i.e., use the “solid” labels on the first film and the “CNB” labels on the second).

Q.   May I place the sticky labels anywhere on the film?
A.   No. Place the sticky label below the image it identifies. Do not cover any pertinent clinical or identification information. (For example, if necessary, you may cover the pectoralis muscle with the label as long as it does not cover any breast tissue.) If the label will not fit, place it as close as possible to the image it identifies and use a wax pencil to draw an arrow to the correct image.

Q.   For biopsies, we are using a needle that has an intermediary needle position between the pre-fire position and the post-fire position. Must we submit the intermediary images with the accreditation testing materials?
A.   If your site uses a 2-step, spring-loaded, tru-cut needle, the pre-fire image must show the needle tip at the leading edge of the mass. Do not submit the pre-fire with the inner needle extended into the mass since this image is difficult to distinguish from the post-fire view.

Quality Assurance and Quality Control

Q.   Do we need to have a physician peer-review program in place (e.g., RADPEER™) for Breast Ultrasound Accreditation?
A.   Yes. Participation in a peer-review program, such as RADPEER™, is required for Breast Ultrasound Accreditation. However, it is not required for the Ultrasound-Guided Breast Biopsy Module, since applicants already have to submit biopsy outcome data (# procedures, # cancers, # complications, etc.).

Q.   Do we need to have a physician peer-review program in place (e.g., RADPEER™) for the Ultrasound-Guided Breast Biopsy Module?
A.   No. In order to accredit in the Ultrasound-Guided Breast Biopsy Module, applicants already have to submit biopsy outcome data (# procedures, # cancers, # complications, etc.). However, participation in a peer-review program is still required for breast ultrasound. See the Breast Ultrasound Program Requirements for details.

Q.   On the quality assurance questionnaire, we are asked to provide patient volume and outcome data. Should this data be from a specific time period?
A.   Yes. If possible, submit your facility’s patient volume and outcome data from the past 12 months.  If you are a new facility, submit all the patient volume and outcome data you have available.

Q.   What quality control data do we need to submit for accreditation?
A.   As part of accreditation, you must submit a copy of your service engineer’s most recent preventative maintenance report or your medical physicist’s most recent equipment survey for each unit used for breast ultrasound. Although the ACR does recommend that routine quality control (QC) be performed by the technologist on all ultrasound units used for breast imaging, this is not required for accreditation at this time. See the Breast Ultrasound Program Requirements for details.

Q.   We received 3 barcode labels for QC but have only two active units. Should we discard the extra label?
A.   No. ACR sends one QC label per active unit in our system. If you have received too many or too few QC labels, please call the Diagnostic Modality Accreditation Information Line at 800-770-0145 to update your information.

• Breast Ultrasound FAQ PDF Version