ACCREDITATION CASE REVIEW 2: US AND US-GUIDED BIOPSY CRITERIA
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1 ACCREDITATION CASE REVIEW 2: US AND US-GUIDED BIOPSY CRITERIA Stamatia Destounis, MD, FSBI, FACR Elizabeth Wende Breast Care, LLC Clinical Professor University of Rochester School of Medicine and Dentistry
2 US ACCREDITATION Peer review and constructive feedback of the applicant s site o Staff qualifications o Equipment o Quality Control o Quality Assurance o Accuracy of needle placement and image quality Submission of material is subject to timelines and requirements o Fees apply o 45 days from the date the testing materials are sent by ACR to complete (due date is on the labels) o Call the number is you have problems meeting the deadline o Review takes approximately 90 days from the time the ACR receives the material
3 PERSONNEL QUALIFICATIONS All personnel must meet and document specific requirements Continuing education/experience are based on the 3 previous years prior to accreditation date (if not all are obtained in the timeframe, the ACR will accept credits/experience in the accreditation year) Physicians - continuing experience 200 breast US exams in last 36 months, continuing education meet MOC or complete 150 hours in the prior 36 months Sonographers/Technologists ARDMS or RDMS or ARRT with post primary certification and current registration in breast sonography, 24 hours of CE every 2 years Physicists
4 QC & PHYSICIST TESTING Complete the required forms for submission Maintain documentation of all QC and physicist testing ACR strongly recommends that QC be done under the supervision of a qualified medical physicist If this is not possible-may be performed by trained personnel with US imaging experience Annual Survey-system performance evaluation (required) Acceptance testing-optional but recommended highly Preventative Maintenance
5 ANNUAL SURVEY (REQUIRED) Physical and Mechanical Inspection Image Uniformity and Artifact Survey Geometric Accuracy (optional) System Sensitivity US Scanner Electronic Image Display Performance Primary Interpretation Display Performance (if located at facility where US is performed) Contrast Resolution (optional) Spatial Resolution (optional) Evaluation of QC Program (if applicable)
6 QC TESTS (OPTIONAL BY TRAINED STAFF) Performed by appropriately trained sonographers/service engineers and expected for a continuous QC program Physical and Mechanical Inspection (Semiannually) Image Uniformity and Artifact Survey (Semiannually) Geometric Accuracy (Semiannually) US Scanner Electronic Image Display Performance (Semiannually)
7 EQUIPMENT Breast US must be performed with High resolution, real time, linear array scanners Transducers that operate at a center frequency of at least 10 MHz (preferably higher) Equipment capable of electronic focal zone(s) adjustment
8 ACR website -Quality & Safety tab -Accreditation
9 Breast Ultrasound
10 Phone number, Program Requirements, Frequently Asked Questions, Register/Log In, Gather Data, Prepare for Site Visits
11 CLINICAL IMAGES Breast Ultrasound Accreditation If facility does not perform US guided biopsy Ultrasound-Guided Breast Biopsy Module Facilities that perform US and US guided biopsies Required Examinations Breast US Module Simple cyst, and Solid mass US-Guided Biopsy Module Core needle biopsy, and/or Fine needle aspiration cytology
12 CLINICAL IMAGES Breast Ultrasound Accreditation If facility does not perform US guided biopsy Breast US Accreditation (both cases required) Simple Cyst 1. 2 orthogonal mammographic views with a single cyst circled and visible on both Solid Mass 1. 2 orthogonal mammographic views with a single mass circled and visible on both 2. 2 orthogonal sonographic views (e.g., 1 transverse, 1 sagittal) with no calipers visible on the cyst 2. 2 orthogonal sonographic views (e.g., 1 transverse, 1 sagittal) with no calipers visible on the mass 3. 1 sonogram image with appropriate caliper measurements 3. 1 sonogram image with appropriate caliper measurements
13 CLINICAL IMAGES Ultrasound-Guided Breast Biopsy Module Facilities that perform US and US guided biopsies Core Needle Biopsy (one of either case) Devices Used in Fire Mode 1. 2 orthogonal mammographic views with a single solid mass circled and visible on both views Devices Used in Non-Fire Mode (i.e., manually advanced) 1. 2 orthogonal mammographic views with a single solid mass circled and visible on both views 2. Pre-biopsy sonogram showing solid mass in 2 orthogonal views (e.g., 1 transverse, 1 sagittal) 2. Pre-biopsy sonogram showing solid mass in 2 orthogonal views (e.g., 1 transverse, 1 sagittal) 3. Pre-fire sonogram showing needle in long axis 3. Post-biopsy sonogram showing the long axis of the needle in tissue acquiring position, either 4. Post-biopsy (post-fire) sonogram showing under or through the mass needle in long axis
14 CLINICAL IMAGES And/or for FNAC (part of biopsy module) Fine Needle Aspiration Cytology (only submit solid masses: do NOT submit axillary lymph nodes or cyst aspirations) 1. 2 orthogonal mammographic views with a single solid mass (marked/circled and visible on both views) 2. Pre-biopsy sonogram showing solid mass in 2 orthogonal views (e.g., 1 transverse, 1 sagittal) 3. Post-biopsy sonogram showing the needle clearly within the solid mass in the long axis
15 OUTCOME DATA: US-GUIDED BREAST BIOPSY ACCREDITATION MODULE ONLY Overall biopsies Cancer Benign Biopsies needing repeat Complications Repeat CNB Insufficient sample Discordance with imaging Atypia Repeats-FNA Insufficient sample Discordance with imaging Atypia Complications Infection Hematoma Pneumothorax (CNB only)
16 EXAMINATION ID & LABELING Examination Identification Patient s first and last names (REQUIRED) Identification number and/or date of birth (REQUIRED) Examination date (REQUIRED) Facility Name Facility Location Designation of right or left breast (REQUIRED) Anatomic location using clock face notation or labeled diagram of the breast (REQUIRED) Transducer orientation Distance from the nipple to the abnormality measured in millimeters or centimeters (REQUIRED) Sonographer s and/or physician s identification number, initials, or other symbol
17 SUBMISSION
18 123Renewal due:04/05/15 CYST JACKET
19 Jane Doe Elizabeth Wende Breast Care 3/12/2015 Jane Doe R CC Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BY1 C09 Cyst Mammo 1 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 123 Renewal due: 04/05/15 BY1 C09 Cyst Mammo 2 l llllll llll ll llll lllllllllllll llllllllll lll lllllll FAIL
20 Jane Doe R MLO Elizabeth Wende Breast Care 3/12/2015 Jane Doe R CC Elizabeth Wende Breast Care 3/12/2015 Cyst is not circled (common reason for failure) BB /radiopaque marker is present 123 Renewal due: 04/05/15 BY1 C09 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 123 Renewal due: 04/05/15 BY1 C09 l llllll llll ll llll lllllllllllll llllllllll lll lllllll
21 FAIL
22 *Required bar code image sticker is not in place *Exam ID and labeling are not included on image *Distance from the nipple is not provided *Cyst looks complicated (improper technique) *Submitted cyst must meet BI-RADS criteria for simple cyst: anechoic, circumscribed margin, posterior enhancement *Required images (2 orthogonal views and image with calipers) are not included
23 123 Renewal due: 04/05/15 CYST JACKET
24 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/2015 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BY1 C09 Cyst Mammo 1 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 123 Renewal due: 04/05/15 BY1 C09 Cyst Mammo 2 l llllll llll ll llll lllllllllllll llllllllll lll lllllll
25 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/2015 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BY1 C09 Cyst Sono 1 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 123 Renewal due: 04/05/15 BY1 C09 Cyst Sono 2 l llllll llll ll llll lllllllllllll llllllllll lll lllllll
26 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BY1 C09 Cyst Sono with Calipers l llllll llll ll llll lllllllllllll llllllllll lll lllllll PASS
27 123 Renewal due: 04/05/15 SOLID JACKET
28 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/2015 Jane Doe DOB: 11/12/1960 R CC Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BS1 C09 Solid Mammo 1 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 123 Renewal due: 04/05/15 BS2 C09 Solid Mammo 2 l llllll llll ll llll lllllllllllll llllllllll lll lllllll
29 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/2015 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BS3 C09 Solid Sono 1 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 123 Renewal due: 04/05/15 BS4 C09 Solid Sono 2 l llllll llll ll llll lllllllllllll llllllllll lll lllllll
30 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BS5 C09 Solid Sono with Calipers l llllll llll ll llll lllllllllllll llllllllll lll lllllll PASS
31 123 Renewal due: 04/05/15 CNB JACKET
32 Jane Doe DOB: 11/12/1960 R CC Elizabeth Wende Breast Care 3/12/2015 Jane Doe DOB: 11/12/1960 R MLO Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BC1 C09 CNB Mammo 1 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 123 Renewal due: 04/05/15 BC2 C09 CNB Mammo 2 l llllll llll ll llll lllllllllllll llllllllll lll lllllll
33 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/2015 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BC3 C09 CNB Pre Biopsy Sono 1 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 123 Renewal due: 04/05/15 BC4 C09 CNB Pre Biopsy Sono 2 l llllll llll ll llll lllllllllllll llllllllll lll lllllll
34 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BC7 C09 CNB Biopsy Sono for BX l llllll llll ll llll lllllllllllll llllllllll lll lllllll PASS
35 254 Renewal due: 04/05/15 SOLID JACKET
36 Jane Doe DOB: 11/12/1960 L CC Elizabeth Wende Breast Care 3/12/2015 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BS1 C09 Solid Mammo 1 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 254 Renewal due: 04/05/15 BS1 C09 Solid Mammo 2 l llllll llll ll llll lllllllllllll llllllllll lll lllllll
37 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/2015 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/2015 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BS1 C09 Solid Sono 1 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 254 Renewal due: 04/05/15 BS1 C09 Solid Sono 2 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 254 Renewal due: 04/05/15 BS1 C09 Solid Sono with Calipers l llllll llll ll llll lllllllllllll llllllllll lll lllllll FAIL
38 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/2015 Jane Doe DOB: 11/12/1960 Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BS1 C09 Solid Sono 1 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 254 Renewal due: 04/05/15 BS1 C09 Solid Sono 2 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 2 orthogonal views are NOT representing the mass 2 different clock faces Mass is not isolated
39 IMAGE SELECTION Perfect technique Nice borders Obvious/same finding on both the mammogram and US
40 WHAT NOT TO SEND
41 Too subtle Difficult to appreciate in long axis Improper technique: depth and focal zone Improper measurements
42 Do NOT send cyst with complex echoes (does not fulfill the criteria of a simple cyst)
43 Do NOT submit images in which the borders cannot be delineated
44 Do NOT submit images with color Do NOT submit if borders are not obvious and would be hard to measure
45 Jane Doe DOB: 11/12/1960 L MLO Elizabeth Wende Breast Care 3/12/2015 Jane Doe DOB: 11/12/1960 L CC Elizabeth Wende Breast Care 3/12/ Renewal due: 04/05/15 BY1 C09 Solid Mammo 1 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 123 Renewal due: 04/05/15 BY1 C09 Solid Mammo 2 l llllll llll ll llll lllllllllllll llllllllll lll lllllll
46 Jane Doe DOB: 11/12/1960 Jane Doe DOB: 11/12/ Renewal due: 04/05/15 BS1 C09 Solid Sono 1 l llllll llll ll llll lllllllllllll llllllllll lll lllllll 254 Renewal due: 04/05/15 BS1 C09 Solid Sono 2 l llllll llll ll llll lllllllllllll llllllllll lll lllllll
47 Jane Doe DOB: 11/12/ Renewal due: 04/05/15 BS1 C09 Solid Sono with Calipers l llllll llll ll llll lllllllllllll llllllllll lll lllllll FAILED Mammogram and US correlate is NOT obvious (common reason for failure) Formal appeal letter was written to clarify, but ultimately original review stood Take home point: Do NOT send debatable images
48 For US Accreditation module Cyst REPEAT IMAGES If cyst fails, both solid and cyst need to be resubmitted (different case) Solid If solid fails, both solid and cyst need to be resubmitted (different case) For Biopsy/FNAC Accreditation Module If biopsy/fnac fails, repeat only the deficiency Additional fees will apply
49 DEFICIENCIES OR FAILURES Facilities may appeal in writing within 15 days of the date of the final report Send the images that did not pass back with the letter An arbitrator (not a reviewer associated with the original submission) will review and make the final decision Arbitrator results are usually completed within 45 days of ACR receiving the appeal
50 FREQUENTLY ASKED QUESTIONS Adding CNB or FNA module after US accreditation If your facility moves 3D US Supervising physicians Certification/CME Barcode labels QA/QC/Annual testing
51 SUMMARY Submission should be an example of your BEST work The ACR is available to help with a successful US accreditation process Call with questions/support Visit the website for frequently asked questions
52 ACR Breast MRI Accreditation SBI 2016 Lara A. Hardesty, MD, FSBI Associate Professor of Radiology University of Colorado School of Medicine-Denver
53 Breast MRI Accreditation-Why do it? all outpatient facility providers that bill under Part B of Medicare Physician Fee Schedule must be accredited to receive payment for technical component
54 Breast MRI Accreditation-Why do it? As of January 2016 Required for Breast Imaging Centers of Excellence Designation
55 Benefits to Accreditation Marketing: Patients & providers can download a list of accredited sites from ACR webpage by zipcode, state, etc
56 Benefits to Accreditation Provides peer review & feedback: staff qualifications image quality equipment quality control quality assurance MR safety policies
57 Application items: staff qualifications image quality equipment quality control quality assurance MR safety policies
58 Discuss today staff qualifications image quality equipment quality control quality assurance MR safety policies
59 Discuss today staff qualifications image quality equipment quality control quality assurance MR safety policies
60 Personnel Qualifications Physicians Physicists Technologists
61 Personnel Qualifications Have to meet and DOCUMENT!
62 Radiologist Initial Qualifications Board Certified in Radiology or Diagnostic Radiology by: -American Board of Radiology, or -American Osteopathic Board of Radiology, or -Royal College of Physicians and Surgeons of Canada, or -Le College des Medecins du Quebec
63 Radiologist Initial Qualifications Radiologist graduating from residency after June 30, 2014, must be board-eligible as defined by the American Board of Radiology
64 Radiologist Initial Qualifications If board certified before 2008, must also: -Oversight, interpretation & reporting of 150 breast MRIs in last 36 months, OR -Interpretation & reporting of 100 breast MRIs in last 36 months in a supervised situation
65 Radiologist Supervised Situation -Supervising interpreting physician reviews, discusses, & confirms diagnosis of physician being supervised. -Supervising interpreting physician does not have to be present at the time of initial interpretation. -Supervising physician must review & (if necessary) correct final interpretation.
66 Radiologist Supervised Situation Formal course includes lecture format and: 1) database of interpreted cases 2) assessment system traceable to individual participant 3) direct feedback regarding responses Examples: audience response system, monitor based program or individual CD-ROM or web-based instruction system
67 Radiologist Initial Qualifications AND 15 hours of Category 1 (CME) in MRI (can include clinical applications of MRI in breast imaging, MRI artifacts, safety, & instrumentation)
68 Radiologist Qualifications Continuing Experience: 75 breast MRIs in past 36 months
69 Continuing Experience How is time measured? Based on previous full calendar years. Site renews July 2011: Accept CME & exams read from 1/1/ /31/2010 If fall short, will accept 2011 up to application date
70 Technologist Initial Qualification State License (if required for MRI techs) AND Supervised experience in breast MRI AND Supervised experience in administration of IV contrast (if contrast is administered by techs) AND
71 Technologist Initial Qualification Registered in MRI by: -American Registry of Radiologic Technologists (ARRT) -American Registry of MRI Technologists (ARMRIT) -Canadian Association of Medical Radiation Technologists (CAMRT) OR
72 Technologist Initial Qualification Registered in radiography by the ARRT and/or unlimited state license and 6 months supervised clinical MRI scanning experience OR
73 Technologist Initial Qualification Associate s or bachelor s degree in an allied health field and Certification in another clinical imaging field (e.g., ARDMS or NMTCB) and 6 months supervised clinical MRI scanning experience
74 Technologist Qualifications Continuing Experience: 50 breast MRI examinations in the prior 24 months
75 Techs-Continuing Education Registered Technologists: Comply with CE requirements of their certifying organization for modality they perform CE must include credits relevant to breast MRI State Licensed Technologists & Others: 24 hours CE every 2 years, relevant to imaging or patient care CE must include credits relevant to breast MRI
76 Discuss today Application items: staff qualifications image quality equipment quality control quality assurance MR safety policies
77 Clinical Images Submitted Single case showing best work Done in past 6 months Actual patient (not volunteer)
78 Clinical Images Submitted Known, enhancing, biopsy-proven carcinoma Before surgery on the cancer Cancer must be visible on scan
79 Clinical Images Submitted Bilateral native breasts Not mastectomy patient Not TRAM or autologous tissue reconstruction
80 Clinical Images Submitted Can have implants present Can have a history of surgery, including a prior lumpectomy for cancer
81 Submit scout/localizer & these 4 sequences T2-weighted/bright fluid series Multi-phase T1-weighted series: Pre-contrast T1 Early phase (first) post-contrast T1 Delayed phase (last) post-contrast T1
82 Submit scout/localizer & 4 sequences Please submit only these required sequences If submitted sequences are incomplete or incorrect, fail accreditation
83 T2-weighted/bright fluid sequence Single bilateral series or 2 separate series - one on each breast STIR (Short T1 Inversion Recovery) image with T1 set to suppress fat signal is OK if it successfully shows fluid to be bright.
84 Multi-phase T1-weighted series Must be bilateral, R & L breasts in same series May be submitted: 3 separate series OR 2 series (1 pre-gad & 1 post-gad) OR 1 series (pre & post-gad run together)
85 Multi-phase T1-weighted series IV contrast must be visible in both postcontrast T1-weighted series Do not stack or interleave sequences
86 Multi-phase T1-weighted series Use chemical-shift fat suppression If not, subtraction of pre-contrast from postcontrast series must be submitted in addition to the source series for both early & delayed phases
87 Multi-phase T1-weighted series Sequence Acquisition Plane Sagittal, axial, coronal, &/or slightly oblique Slice Thickness <=3.0 mm Gap 0 mm Maximum In Plane Pixel Dimension for Phase & Frequency <=1.0 mm
88 Aurora-submit only scout & 3 sequences Aurora magnets have a pre-contrast T1-weighted series that is also a T2-weighted/bright fluid series Pre-contrast T1W/T2W Early phase (first) post-contrast T1 Delayed phase (last) post-contrast T1
89 If do not pass on first attempt, then what? Do not have to redo entire process; only need to resubmit the clinical case If receive 2 nd deficiency, then fail accreditation. To resume, facility must reinstate with corrective action plan & retest all areas.
90 How does a facility appeal if receive a deficiency or failure? May appeal in writing within 15 days. Send original images & a letter describing reason for appealing. Arbitrator (a reviewer not on initial review) receives images, copies of previous reviews & facility s appeal letter. Arbitrator s determination is final.
91 Questions? Just ask ACR staff is available to help Contacting them multiple times is OK! They want to help you get through the process successfully!
92 Thank you for your help with the MR presentation: Theresa Branham BSRS Director Breast Imaging Accreditation American College of Radiology Kathy Lorig Program Manager Breast Imaging Accreditation American College of Radiology University of Colorado Hospital
93 Contact Information Website Safety/Accreditation/BreastMRI Phone Fax
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