Accreditation Case Review: Mammography and Stereotactic Biopsy

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2 Accreditation Case Review: Mammography and Stereotactic Biopsy Brett T. Parkinson MD Breast Imaging Director Breast Care Services Intermountain Healthcare Chair, ACR Committee on Mammography Accreditation April, 2016

3 The Janice Beesley Hartvigsen Breast Care Center at Intermountain Medical Center

4 Clinical Image Evaluation Scoring Procedures for Screen Film and Full Field Digital Mammography Mammography Accreditation Program

5 Accreditation Objectives Improve quality of mammography Reason for clinical image review -Quality of patient imaging is key -Provide feedback for improvement Uniform assessment of performance

6 Course Objectives Reasons for failed clinical images - Categories - Deficiencies - Problem solving and correcting deficiencies - Improving overall quality of images FS and FFDM criteria are generally same

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11 Imaging Category Failure Rate (%) Positioning 1250 (20) Exposure 944 (15) Compression 887 (14) Sharpness 806 (13) Contrast 785 (13) Artifacts 703 (11) Labeling 465 (8) Noise 288 (5) Total 6128 (100)

12 Breast Density Past: The Old Descriptors

13 Type 1 Almost entirely fat (<10% fibroglandular) Fatty Type 2 Scattered fibroglandular densities (10%-50%) Type 3 Heterogene-ously dense (51%-75% fibroglandular) Dense Type 4 Extremely dense (>75% fibroglandular)

14 Breast Density Present: BI-RADS 2013

15 Breast Composition Categories The breasts are almost entirely fatty There are scattered areas of fibroglandular density The breast are heterogeneously dense, which may obscure small masses The breasts are extremely dense, which lowers the sensitivity of mammography (ACR BI-RADS ATLAS, 2013)

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18 Scattered

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20 Heterogeneously Dense

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22 Extremely Dense

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24 Breast Density Future We await publication of robust volume-based breast density data, using validated percentage cut points (not necessarily quartiles) that are readily and reproducibly determined at imaging, before again indicating percentage ranges for BI-RADS density categories. (ACR BI-RADS ATLAS, p 126, 2013)

25 Overall Clinical Evaluation Form ATTRIBUTE PROBLEM(S) NOTED POSSIBLE CAUSE(S) MLO: Poor visualization of posterior tissues Technologist technique MLO: Sagging breast Inappropriate mammographic projections MLO: Inadequate amount of pectoral muscle shown on image Wrong size recording system MLO: Inadequate inframammary fold (IMF) Uncertain CC: Poor visualization of posterior tissues CC: Excessive exaggeration A. Positioning Portion of breast cut off Skin folds Other body parts projected over breast Breast positioned too high on image receptor Posterior nipple line (PNL) on CC not within 1 cm of MLO PNL B. Compression Poor separation of parenchymal densities Non-uniform exposure levels Patient motion Under compression by technologist Unsuitable compression device Technologist positioning of compression device Uncertain C. Exposure Level D. Contrast Generalized underexposure Generalized overexposure Inadequate penetration of dense areas Excessive penetration of lucent areas Inadequate contrast Excessive contrast Film development Under compression with phototiming Radiologist preference Phototimer variability Uncertain Film development Improper kvp Excessive scatter Underexposure Digital: window width too wide Digital: window width too narrow Uncertain

26 Overall Clinical Evaluation Form ATTRIBUTE PROBLEM(S) NOTED POSSIBLE CAUSE(S) Poor delineation of linear structures Patient motion Poor delineation of feature margins Poor screen contact E. Sharpness Poor delineation of microcalcifications Film-screen selection Uncertain Visually striking mottle pattern Film development Noise limited visualization of detail Recording system speed Improper kvp F. Noise Digital: inadequate SNR Digital: window width too narrow Uncertain Punctate or lint Poor screen maintenance Scratches or pickoff Development related Roller marks Unsuitable grid or Bucky Grid related artifacts Film exposed to light Hair, deodorant, etc Lack of patient preparation G. Artifacts Poor screen-film alignment Digital: detector calibration (e.g. uniformity calibration) Digital: image receptor artifact Digital: foreign objects calibrated into calibration file Digital: laser printer artifact Digital: laser printer needs service Digital: laser printer scanning lines Uncertain Film handling Poor cassette closure Film fogging Damaged cassette H. Exam ID Patient name and additional patient identifier Facility name and location (city, state and zip) Date of examination View and laterality Unit identification (if more than one) Technologist identification Cassette-screen identification Technologist error Missing or non-standard labeling method Improper positioning of label Uncertain

27 Positioning: MLO Most Common Deficiencies Deficiency Frequency (%) Inadequate pectoral muscle 35 Sagging of the breast 22 Poor visualization posterior tissue 22 Skin folds overlying breast tissue 10 Breast positioned too high on image receptor 6 Portion of breast cut off 5

28 RMLO M LMLO N F FG IF FG = fibroglandular tissue; M = Pectoralis muscle; N = Nipple; IF = inframammary fold

29 RMLO Adequate Pectoral Muscle Optimal pectoral muscle on a digital image Length - To nipple line or below Shape - Convex anterior border - Wider superiorly - Gradually narrows inferiorly

30 RMLO Inadequate Pectoral Muscle When compared with a straight line, at a minimum the muscle should align with the line or go beyond Preferably, it will bulge beyond the edge Note difference in width of superior vs inferior aspect of muscle

31 Sagging Breast: Poor Delineation of Structures Inadequate muscle Overlapping breast tissues N skin fold Fail

32 To prevent sagging: Out and Nipple-Up Maneuver

33 Sagging breast Inadequate muscle Repeated exam N skin fold N

34 Sagging Breasts with Inframammary Skin Folds Fail

35 Open IMF

36 Open Inframammary Fold MLO Skin overlying abdomen in front of edge of receptor Free of skin folds IMF

37 Positioning Criteria: CC Inclusion of medial tissue Nipple centered on film - No excessive exaggeration - Exaggeration may cause loss of medial or lateral posterior tissue Inclusion of posterior tissue Free of skin folds

38 Positioning: CC Most Common Deficiencies Deficiency Frequency (%) Poor visualization of posterior tissue on CC Posterior nipple line on CC not within 1 cm of MLO Excessive lateral/medial exaggeration on CC Skin folds overlying breast tissue

39 Visualization of Posterior Breast on CC PNL should measure within 1 cm of MLO - Depends on a well positioned MLO Pectoral muscle can be seen in 30% of women Requires proper positioning of CC: - Elevate inferior breast (freely movable tissue) - Pull superior and inferior tissue onto receptor - Lean patient s head forward to the side of tube Pectoral muscle in central and medial breast - Improper positioning if central and lateral

40 RCC LCC LMLO PNL N FG F N PNL M N PNL (Posterior Nipple Line) on CC should be within 1cm of MLO

41 N PNL = 10 cm N PNL = 11.5 cm IMF was not elevated IMF properly elevated

42 Inclusion of Medial Tissue Skin reflection of cleavage visualized Retroglandular fat - Sternum flush with bucky - Contralateral breast draped Free of skin folds - IMF properly elevated - Check for gap - Must look from medial side

43 Nipple Centered on Film No excessive exaggeration Otherwise, nipple will point to the missing tissue - If points laterally RT should lift and pull out lateral tissue - If points medially RT should rotate to place sternum flush with bucky N RCC PNL N

44 Excessive Exaggeration Nipple will point to the laterality of missing tissue N - If it points laterally, lift and pull out lateral tissue - If points medially, rotate to place sternum flush with bucky Borderline

45 Skin Folds Overlying Breast Fail

46 Inframammary skin folds Borderline Pass, possibly a Fail, Depend on other images: Pec

47 Medial skin folds on CC Borderline

48 Affects sharpness Compression - Compression decreases unsharpness (blur) due to reduced time and motion Affects contrast - Good compression increases contrast due to less scattered radiation Affects exposure level - Compression increases exposure level due to reduced breast thickness

49 Compression: Most Common Deficiencies Deficiency Frequency (%) Poor separation of fibroglandular tissues 65 Non-uniform exposure of fibroglandular tissues 19 Patient motion 16

50 Inadequate Compression Poor separation of fibroglandular tissues Unequal exposure of fibroglandular tissues Motion unsharpness

51 Assessing Sharpness on the MLO Anterior edge of pectoral muscle (blurred?) Subareolar area Inferior breast - Edges of vessels, calcifications, and Cooper s ligaments Fail

52 Compression Year 1 Year 2 Year 3 Fail Borderline Pass

53 Assessing Sharpness on CC Subareolar area Medial breast - Edges of vessels, calcification, ligaments

54 Exposure Level Minimum average optical density (OD) in fibroglandular tissue should be 1.0 when measured with a spot densitometer Fibroglandular tissue should be a shade of gray Pectoral muscle may have OD under 1.0; however, must be able to see underlying tissue Uniformly washed out look indicates under- exposure on screen film images

55 Exposure Level: Most Common Deficiencies Deficiency Generalized underexposure Inadequate exposure of dense tissues Generalized overexposure Overexposure of radiolucent tissues Frequency (%) (80) (20)

56 Inadequate exposure = inadequate contrast RMLO LMLO RMLO LMLO Initial Exam Fail 6 Months Later Pass

57 RCC LCC RCC LCC Initial Exam 6 Months Later

58 Contrast Differences in optical densities between different tissues. Fat should have high optical density (blacker) and fibro-glandular tissue should have much lower optical density (whiter).

59 Contrast: Most Common Deficiencies Deficiency Frequency (%) Inadequate contrast 90 Excessive contrast 10

60 Contrast Inadequate Good Excessive

61 Good Contrast Film-Screen and Digital: Same Patient LCC LCC

62 Sharpness Unsharpness (often referred to as blur by medical physicists) Blurring of margins of vessels and Cooper s ligaments Unclear margins of masses Unsharpness of calcifications

63 Assessing Sharpness on the MLO Inferior third of the breast Subareolar area Anterior edge of pectoral muscle Edges of vessels, calcification, and Cooper s ligaments

64 Inadequate Compression Motion unsharpness seen as poor delineation of linear structures This is usually most evident in inferior and subareolar aspect of MLO Also look at the edge of the pectoral muscle Fail Edge of pectoral muscle

65 Motion unsharpness Borderline

66 Assessing Sharpness on the CC Medial aspect of the breast Subareolar area Edges of vessels, calcifications, Cooper s ligament

67 Unsharpness related to inadequate compression and motion more likely to occur on MLO If question about sharpness, compare CC to MLO

68 Noise Mottled pattern of areas of relatively equal tissue density Noise limits visualization of details in the image

69 Mottled pattern of areas of relatively equal tissue density

70 If noise suspected, it helps to use a mag lens

71 Mottled pattern makes it difficult to see fine details in the images

72 Failing Score A substantial deficiency in any category can cause a failure Multiple borderline deficiencies in multiple categories can also cause a failure Category G: Artifacts Minor artifacts will not cause a fail prominent artifacts will be considered borderline Severe artifacts will cause a fail Category H: Examination ID If the patient s name, patient ID or R/L are missing, the examination will fail Other minor exam ID deficiencies will not fail

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100 ACR Stereotactic Breast Biopsy Accreditation Program

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102 SBBAP: Physician Qualifications ACR and the American College of Surgeons agreed on and published guidelines for physician training, qualifications, and continuing experience* Collaborative setting: radiologists and surgeons work together Independent settings: radiologists or surgeons work independently * (ACR Bull, Jul 1998; Bull Am Coll Surg, May 1998 )

103 SBBAP: Physician Qualifications - Collaborative Setting Qualifications Radiologist* Other Physician Initial Performed 12 stereotactic breast Bx procedures or 3 hands-on stereotactic breast Bx procedures under a qualified physician AND 3 hours of Category 1 CME in stereotactic breast Bx AND Experienced in recommendations for Bx and lesion identification at time of Bx AND Qualified as an interpreting physician under MQSA AND 3 hours of Category 1 CME in stereotactic breast Bx (that includes image triangulation for lesion location) AND Experienced in post-bx patient management *radiologists must be currently qualified as an interpreting physician under MQSA

104 SBBAP: Physician Qualifications - Collaborative Setting Qualifications Radiologist Other Physician Continuing Experience Upon renewal, 36 image-guided breast Bx in prior 36 months; at least 9 of these must be stereotactic breast Bx Continuing Education Upon renewal: Currently meets MOC requirements for ABR, OR Completes 150 hours (including 75 Cat 1 CME) in prior 36 months pertinent to the physician s practice patterns, OR Completes 15 hours CME (half of which must be Category 1) in the prior 36 months specific to the imaging modality or organ system

105 Qualifications Radiologist* Other Physician Initial SBBAP: Physician Qualifications - Independent Setting Performed 12 stereotactic breast Bx procedures or 3 hands-on stereotactic breast Bx procedures under a qualified physician AND 3 hours of Category 1 CME in stereotactic breast Bx AND 15 hours of Category 1 CME in breast imaging including pathophysiology of benign and malignant breast disease as well as clinical breast examinations AND Qualified as an interpreting physician under MQSA AND 15 hours of Category 1 CME in stereotactic breast Bx or 3 years experience having performed 36 stereotactic breast Bx AND 4 hours of Category 1 CME in medical radiation physics AND Evaluated 480 mammograms every 2 years in consultation with MQSA-qualified physician *radiologists must be currently qualified as an interpreting physician under MQSA

106 SBBAP: Physician Qualifications - Independent Setting Qualifications Radiologist Other Physician Continuing Experience Upon renewal, 36 image-guided breast Bx in prior 36 months; at least 9 of these must be stereotactic breast Bx Upon renewal, 36 image-guided breast Bx in prior 36 months; at least 9 of these must be stereotactic breast Bx AND Evaluate 720 mammograms in the prior 36 months in consultation with MQSA-qualified physician Continuing Education Upon renewal: Currently meets MOC requirements for ABR, OR Completes 150 hours (including 75 Cat 1 CME) in prior 36 months pertinent to the physician s practice patterns, OR Completes 15 hours CME (half of which must be Category 1) in prior 36 months specific to the imaging modality or organ system

107 SBBAP: Radiological Technologist Qualifications Initial Qualifications Radiological Technologist Qualified to perform mammography under MQSA AND 3 Category A CEUs in stereotactic breast Bx AND Performed 5 stereotactic breast Bx procedures under supervision of a qualified physician or technologist Continuing Experience Upon renewal, 24 stereotactic breast Bx exams in prior 24 months

108 Qualifications SBBAP: Radiological Technologist Qualifications Radiological Technologist Continuing Education Registered technologists - In compliance with CE requirements of certifying organization for the imaging modality in which they perform services - CE includes credits pertinent to tech s accredited practice State licensed technologists - 24 hours of CE every 2 years - CE relevant to imaging and radiologic sciences, patient care - CE includes credits pertinent to tech s ACR accredited practice All others - 24 hours of CE every 2 years - CE relevant to imaging and radiologic sciences, patient care - CE includes credits pertinent to tech s accredited practice

109 SBBAP: Medical Physicist Qualifications Initial Qualifications Medical Physicist Qualified to perform mammography surveys under MQSA AND Performed 1 hands-on stereotactic breast Bx survey under a qualified medical physicist or at least 3 independent surveys prior to 6/1/97 Continuing Experience Continuing Education Upon renewal, 2 stereotactic breast Bx physics surveys over a 24-month period Upon renewal, 3 CEUs in stereotactic breast Bx every 3 years

110 SBBAP: Quality Assurance - Outcome Data 110 Total number of procedures Total number of cancers found Total number of benign lesions Total number of stereotactic Bx needing repeat Bx (open excisional or stereotactic Bx) Insufficient sample Non-concordance with imaging Ductal atypia, radial scar Other Total number of complications Hematomas requiring surgical attention Infections requiring treatment Other

111 SBBAP Pass Rate 82% of units passed on 1 st attempt (2011) All units at the site must pass evaluation for accreditation to be maintained A certificate and decal will be issued for each unit Accreditation is granted for three years

112 SBBAP: Reasons for Failures 1 st attempt: Failures are primarily clinical, targeting issues Phantom failures also show image quality problems Dose failures (300mrad) much higher than in MAP After corrective action, less than 2% of total applicants fail again

113 Image Submission Requirements

114 Gun-needle biopsy probe required images a. A 2-view mammogram Circle the calcifications Print the images true size (i.e., without magnification or minification) or with a scale. Label the images Calc Mammo 1 and Calc Mammo 2 using the ACR barcode labels. b. A specimen radiograph Label the image Specimen Radiograph using the ACR barcode label. c. A Pre-Fire stereo Pair Label the images Calc Pre Fire Str Pair using the ACR barcode labels.

115 Vacuum-suction biopsy probe or other FDA-approved core biopsy device a. Pre-biopsy mammogram and specimen radiograph same as gunneedle biopsy probe. b. Pre-Biopsy (post fire) stereo pair Label the images Calc Pre Biopsy Str Pair using the ACR barcode labels. OR c. Pre-Fire Stereo Pair Label the images Calc Pre Fire Str Pair using the ACR barcode labels.

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118 PRE FIRE

119 POST FIRE/PRE BIOPSY

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127 Questions?