The American College of Radiology Breast Ultrasound Accreditation Program: Frequently Asked Questions

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1 The American College of Radiology Breast Ultrasound Accreditation Program: Frequently Asked Questions Table of Contents APPLICATION - GENERAL... 1 MOVED FACILITIES AND UNITS... 3 EQUIPMENT... 4 PERSONNEL... 4 ACCREDITATION TESTING... 7 QUALITY ASSURANCE AND QUALITY CONTROL BREAST IMAGING CENTERS OF EXCELLENCE Application - General (Also see General Accreditation Frequently Asked Questions for additional questions.) 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 Accreditation - American College of Radiology today! If our on-line information does not address your specific question, please call us using the Breast Imaging Accreditation Programs at (800) 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. 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. Q. Our facility is currently accredited by the ACR. When should we expect to be notified that it is time to renew? Page 1 of 14

2 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 Breast Imaging Accreditation Programs at (800) 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 Breast Imaging Accreditation Programs at (800) for guidance. Q. We submitted our testing materials 3 weeks ago. When will we get our results? A. The accreditation review process takes approximately 90 days 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. Page 2 of 14

3 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 Breast Imaging Accreditation Programs at (800) 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 $700. If you have 13 months or less, you will need to start the renewal process early. Please contact the Breast Imaging Accreditation Programs at (800) for further information. Q. If we failed accreditation only because our images were not labeled with all of the required information, can we resubmit the same case when we repeat and add the information that was missing? A. No. Once a case has been submitted for accreditation and deemed inacceptable, that same case cannot be resubmitted for accreditation for any reason. 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 Page 3 of 14

4 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. May our physicians double read in order to meet the continuing experience requirements? A. Yes, double reading (2 or more physicians interpreting the same examination) is acceptable to meet the continuing experience requirements. Interpreting physicians may also re-interpret a previously interpreted examination and count it towards meeting the continuing experience requirement, as long as he/she did not do the initial interpretation. Q. In order to obtain continuing education credit for breast ultrasound must the coursework be specifically designed for breast ultrasound? A. No. Many general or breast continuing education activities include topics relevant to breast ultrasound. The following are just a few examples Breast imaging conference that included discussion of breast ultrasound Breast tumor board meeting that include cases undergoing breast ultrasound 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. This can be done by documenting how much time was spent on the breast ultrasound related subject and attaching a note to the syllabus or CME certificate. See the Breast Ultrasound Program Requirements for details on personnel requirements. Q. May I count time spent presenting courses/lectures and/or reading/writing articles/papers towards the continuing education requirements? Page 4 of 14

5 A. Personnel may possibly receive continuing education credit for presenting courses/lectures and/or reading/writing articles/papers for journals. These credits must be from organizations who can assess and document the appropriate amount and type of continuing education awarded for the individual article/paper or course/lecture and are authorized to award such credit. Personnel should get a letter or other documentation from the authorized organization stating how many and what type of continuing education credits are awarded and the date the credit was given. Faculty may claim credit for teaching in programs designated for AMA PRA Category 1 Credit by applying directly to the AMA. Two AMA PRA Category 1 Credits are awarded for every hour of interaction, up to 10 credits per year. The application is available at in the Physician Applications section. You will need to download, complete and submit the Direct Credit Application to the AMA for credit. No credits are given for repeat presentations of the same material, it is the responsibility of the applicant to only claim the credit once, and credit may not be simultaneously earned as both a presenter and learner. Additional information on obtaining continuing education credit for these activities is also available for medical physicists from CAMPEP at and for technologists from ASRT at 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 Page 5 of 14

6 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 Breast Imaging Accreditation Programs at (800) 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. Must all technologists performing breast ultrasound procedures have RDMS or ARRT (sonography) certification? A. No. Technologists performing breast ultrasound who do not have RDMS 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 RDMS 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 RDMS-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, RDMS). Page 6 of 14

7 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. Q: May our Physician s Assistant independently perform ultrasound guided breast biopsy procedures at our accredited facility? A: No. Only qualified physicians may independently perform ultrasound guided breast biopsy procedures at facilities accredited by the ACR. Physician Assistants cannot perform without a qualified physician being in the room at the time of the biopsy procedure. Q: May our Radiologist s Assistant independently perform ultrasound guided breast biopsy procedures at our accredited facility? A: No. Only qualified physicians may independently perform ultrasound guided breast biopsy procedures at facilities accredited by the ACR. Radiology Assistants cannot perform biopsies without a qualified physician being in the room at the time of the biopsy procedure. 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: Can breast ultrasound images be submitted for accreditation with color Doppler? A: No, breast ultrasound images with color Doppler are not acceptable images. B mode images should be submitted and Doppler should be used selectively. 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? Page 7 of 14

8 A. No. The mammograms must have been performed no earlier than 60 days before the sonogram 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, the cyst/mass is circled and they are 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) or they must be printed with a scale. If you minify the images to fit them all on 8x10 film and do not provide a scale, 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. Are images that are acquired from a 3D mammography unit ( Tomosynthesis views) allowed to be submitted for the 2 orthogonal views correlating mammogram? A. Images acquired from the 3D mammography unit are only allowed In Addition to the orthogonal projections (e.g., CC and MLO, CC and ML, CC and LM). C-View Images are acceptable. 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 and clearly circled 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. No. You must submit standard full-view mammograms (e.g., CC and MLO, CC and ML, CC and LM) that show the cyst/mass under evaluation in both views so that the reviewer may determine the location of the cyst/mass within the breast. However, you may also submit projections such as compression spots or magnification views to further demonstrate the cyst/mass. As with the standard views, the cyst/mass must be clearly circled. 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 Page 8 of 14

9 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 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. No. If you only perform FNAC of lymph nodes, you should not submit these cases for accreditation. However, if your facility starts performing FNAC of solid breast masses in the future, you may add this module and apply for FNAC at that time. Q. When we submitted our application for the Biopsy Module of Breast Ultrasound Accreditation, we indicated that we also perform fine needle aspiration cytology (FNAC). However, we do so only on lymph nodes in the axilla region and are unable to provide mammograms which identify the area of biopsy in 2 projections as required. Since we do not perform FNAC of breast tissue, are we required to submit clinical examples of the lymph node FNAC in order to be accredited? A. No. Since your facility only conducts FNAC on lymph nodes in the axilla region and not of the breast tissue, you do not need to accredit this procedure. Your lead interpreting physician must formally request to withdraw from FNAC accreditation and provide the reasons why in a letter to the ACR. However, if, in the future, your facility decides to perform FNAC of the breast tissue, you must submit an application to accredit FNAC in order to maintain your Breast Ultrasound Accreditation with the ACR. 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 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. Page 9 of 14

10 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. 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. 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) , 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. Our core needle biopsy (CNB) device can be used in either a fire mode or a non-fire mode. What images and labels should be submitted for the CNB application? A. The ACR Committee on Breast Ultrasound Accreditation recognized that current biopsy devices may be used in different ways and updated the program s Testing Instructions in June 2011 in order to accommodate these changes. The images and labels you submit for CNB will depend on how you used the device for the case you decide to submit for accreditation. If you used the device in a fire mode (i.e., the needle was fired into the tissue sampling position), you should submit the pre-biopsy sonograms, the pre-fire sonogram (with the needle) and the postbiopsy (post-fire) sonogram. If you used the device in a non-fire mode (i.e., the needle was manually advanced into the biopsy position) you should submit the pre-biopsy sonograms and the post-biopsy sonogram. In any case, be sure to read and follow the Testing Instructions for the complete information. Q. When we perform a core needle biopsy (CNB) we fire the needle into the breast but then manually advance the needle into tissue biopsy position in order to obtain the tissue sample. Does the ACR consider this device to have been performed in the fire mode? What images and labels should be submitted for the CNB application? Page 10 of 14

11 A. No. Because you manually advanced the needle into biopsy position, you used the device in the non-fire mode. You should submit the pre-biopsy sonograms and the post-biopsy sonogram. Be sure to read and follow the Testing Instructions for the complete information. 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 The American College of Radiology recently published new QC requirements for their Ultrasound and Breast Ultrasound Accreditation Programs. Effective June 1, 2014, all accredited facilities or facilities applying for accreditation must comply with the minimum quality control tests and frequencies listed in the Program Requirements. The new requirements call for an Annual Survey to be performed by a qualified medical physicist or appropriately trained personnel with ultrasound imaging equipment experience who has been approved by the lead interpreting physician as well as the recommendation that routine QC by appropriately trained sonographers or service engineers be completed.. On June 1, 2014, as part of the accreditation application, facilities must demonstrate compliance with the ACR requirements for QC by providing: Reports from the most recent ultrasound Annual Survey performed by the medical physicist or designee Documentation of corrective action (if the Annual Survey and/or QC data identified performance problems) Please feel free to contact us at or if you have questions about ultrasound or breast ultrasound accreditation. General Q. Why is ACR requiring that QC be conducted for ultrasound and breast ultrasound as part of their accreditation programs? A. Both the Committees on Ultrasound and Breast Ultrasound Accreditation understand that QC is a vital part of quality imaging and patient safety. For many years, the ACR has alerted accredited facilities through the Program Requirements that although the ACR will not initially use this [QC] information to determine whether a facility passes or fails accreditation, it may be used in the future to set criteria. Since most facilities are performing QC as a result of the above notification, the committees decided that it was time to begin requiring QC as part of accreditation. Medical physicist and radiologist members of the 2 committees decided on the tests and frequencies to be performed, as well as who is responsible for their performance. In addition, the committees strongly recommend that QC be done under the supervision of a qualified medical physicist. Q. Will not having the Annual Survey prevent a facility from becoming accredited? A. Yes. Effective June 1, 2014, the ACR will not grant accreditation if documentation of compliance with ACR QC requirements is not provided. Page 11 of 14

12 Q. If a facility is applying for accreditation between June 1, 2013 and May 31, 2014 (before the new requirements go into effect) should they submit the Annual Survey report? A. No. Facilities will not be asked to submit documentation of an Annual Survey if we receive their application between June 1, 2013 and May 31, However, they should use this time period to begin establishing a QC program if they have not done so before. The currently required semi-annual routine quality control testing for the Ultrasound Accreditation Program and the medical physicist or service engineer report for Breast Ultrasound Accreditation Program must still be submitted. Q. What is the difference between Acceptance Testing, Annual Surveys and routine QC Testing? Many of the tests appear to be the same. A. Acceptance testing is the initial performance testing of newly installed or repaired imaging equipment (or components) that are completed before clinical use. Acceptance testing should be comprehensive and include all tests done for the Annual Survey to provide complete performance baselines for comparison with future test results. Annual Surveys are complete tests performed once a year by the medical physicist or designee to assess the performance of the equipment. Although Annual Surveys include all of the same tests conducted during routine QC testing, it is intended to be more extensive. In addition, Annual Surveys include an evaluation of the facility s routine QC program, if applicable. Routine QC testing is less extensive and is recommended to be performed semiannually by the facility s sonographer (or a service engineer). Q. Will the facility be required to purchase a phantom? A. No. 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 5 and use of transducer evaluation devices which test the electrical and acoustic characteristics of each individual transducer array element 6, may also be used, but may not replace any of the required tests. Additional information may be found in the ACR Technical Standard for Diagnostic Medical Physics Performance Monitoring of Real-time Ultrasound Equipment. Q. Is Preventive Maintenance required? A. Regular preventive maintenance should be performed and documented by a qualified equipment service engineer following the recommendations of the equipment vendor. Annual Surveys Q. Will facilities have to provide proof that appropriately trained personnel with ultrasound imaging equipment experience conducting the Annual Surveys have been trained when they apply for accreditation? A. No. Presentation of documentation of training is not required as part of the accreditation application. However, the facility must be sure all requirements for personnel are met when they apply for accreditation with the ACR. During ACR Site Visits, the surveyors will request to see verifying documentation. Failure to demonstrate that personnel are qualified could adversely affect accreditation status. Q. Who must provide the training for appropriately trained personnel with ultrasound imaging equipment experience conducting Annual Survey? A. The ACR strongly recommends that the training for the appropriately trained personnel with ultrasound imaging equipment experience be provided by a qualified medical physicist. If unable to Page 12 of 14

13 acquire training by a qualified medical physicist, training can be achieved through the ultrasound equipment manufacturer or through an appropriate course. Documentation of such training is strongly encouraged. Facilities should keep such documentation on file, but should not submit this documentation with accreditation submissions. Q. If a test performed during the annual survey fails, how long do we have until we must contact service and take corrective action? A. 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. In any event, effective June 1, 2014, the ACR will not grant accreditation if documentation of compliance with ACR QC requirements is not provided; if any tests fail, you must provide documentation of corrective action with your accreditation material. Q. Is there an ACR-provided form the medical physicist (or designee) must use to record his/her Annual Survey test data and results? A. The qualified medical physicist (or designee) may use whatever forms he/she deems appropriate for their Annual Survey. However, effective June 1, 2014, the medical physicist (or designee) must also provide a summary of the Annual Survey pass/fail test results. They may complete the ACR-provided Annual Survey Evaluation Report Summary form or provide their own summary as long as it itemizes the pass/fail results for each required test. Q: Is Acceptance Testing a mandatory requirement? A: While not required, there is value to 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 may also be used to establish a timeline for completion of the annual survey. Q. We have had our ultrasound unit for several years prior to the effective date of this new accreditation requirement and had no acceptance testing performed upon installation. What documentation must we maintain for acceptance testing if none was performed? A. Since no acceptance testing was performed, no documentation of such testing can be maintained. The ACR understands that. As long as Annual Surveys are performed routinely and appropriate documentation is maintained, this will be sufficient. Q. If the scanner has only one transducer should all the QC tests be repeated in each port or does verifying that the transducer connects properly in each port satisfy the requirement? A. Ideally each transducer and port should be tested. In the case of single probe, it is likely left plugged into the same port all the time, and other ports are not used. Due to this, not testing the other ports would be acceptable for accreditation purposes. Routine Quality Control Testing Q. After June 1, 2014, must we submit documentation of routine QC performed by the sonographer as part of the accreditation application? A. No, the ACR will not ask for documentation of routine QC performed by the sonographer as part of the accreditation application. Although strongly recommended to ensure continual acceptable Page 13 of 14

14 performance of US equipment, semiannual QC will no longer be required for submission for ACR US accreditation effective June 1, Q. Who should perform the routine QC tests? A. The routine QC tests are typically performed by appropriately trained sonographers or service engineers. Q. Who must provide the training for appropriately trained sonographers or service engineers conducting routine QC? A. The ACR strongly recommends that the training for appropriately trained sonographers or service engineers conducting routine QC be provided by a qualified medical physicist. If unable to acquire training by a qualified medical physicist, training can be achieved through the ultrasound equipment manufacturer or through an appropriate course. Q. Should a facility assign the lead sonographer to perform routine QC tests? If so, do we need to notify ACR who that person will be? A. It is not required that the lead sonographer be assigned the duty of conducting routine QC. This is the facility s decision. You do not need to notify ACR of the designated staff performing QC. Q. Is there an ACR-provided form that we must use to record our data and results from our routine QC tests? A. No. 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 contact the equipment manufacturer to see if any are available through them. Q. Can the in air test (item 2 in the "Routine QC" table on page 8) be considered the replacement for uniformity test? A. 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. When obtaining uniformity assessment for the physicist's annual survey (item 2 in the "Annual System Performance Evaluation" table on page 7) 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. Breast Imaging Centers of Excellence Q. Where can I get information on BICOE? A. Visit the ACR accreditation web site at and click on the BICOE gold seal. There you will find BICOE requirements and other information. Page 14 of 14

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