Facility, Unit and Test Equipment Data

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1 Facility, Unit and Test Equipment Data Medical hysicist's Tests - SAMLE FORMS Facility Information Facility Name Happy Valley Mammography Address Suite 1 Address 1 Oak Street City, State, Zip Anywhere ST MA ID# (00000) MA Unit# ( ) 05 Lead Interpreting Radiologist Dr. Mary Awsome Quality Control Technologist Sue Fantastic, RT(R)(M) Survey Date August 29, 2016 M Report Date August 31, 2016 Date of revious Survey July 16, 2015 DM Unit Information X-Ray Unit Manufacturer Ford X-Ray Unit Model Imager X-Ray Unit Control Serial # January 2, 2015 X-Ray Unit Date of Manufacture January 3, 2015 X-Ray Unit Date of Installation X DR X CR Boeing CR Reader Manufacturer 5000 CR Reader Model CR Reader Serial # January 3, 2016 CR Date of Manufacture January 6, 2016 CR Date of Installation March 6, 1900 SID (cm) 66 DC Offset ma Large 100 ma Small 40 Magnification Stand Factor Used 1.5 Nominal ixel Size (µm) 100 Test Equipment Info ACR DM hantom Manufacturer and S/N Sunbeam 333 Dosimeter Manufacturer/Model Apple 1010 Dosimeter Calibration Date August 31, 2016 kvp Meter Manufacturer/Model Sanyo Volt kvp Meter Calibration Date September 1, 2016 Medical hysicist Info Medical hysicist Name Jane Incredible, hd Telephone Number (444) mmm@ppp.edu Signature Medical hysicist's Section 6. M FORMS - Final_ Sample

2 1. Mammography Equipment Evaluation (MEE) MA ID-Unit# ( ) Survey Date August 29, 2016 MQSA Requirements for Equipment [FDA Rule Sec (b)] - only applies to MEE Feature Motion of tubeimage receptor assembly Image receptor sizes Light fields Magnification Focal spot selection Application of compression FDA Rule 3(i) 3(ii) 4(iii) 5 6(i) 6(ii) 7(i) 7(ii) 7(iii) 8(i)(A) 8(i)(B) 8(ii)(A) Requirement The assembly shall be capable of being fixed in any position where it is designed to operate. Once fixed in any such position, it shall not undergo unintended motion. This mechanism shall not fail in the event of power interruption. Systems used for magnification procedures shall be capable of operation with the grid removed from between the source and image receptor. For any mammography system with a light beam that passes through the X-ray beam-limiting device, the light shall provide an average illumination of not less than 160 lux (15 ft-candles) at 100 cm or the maximum sourceimage receptor distance (SID), whichever is less. Systems used to perform noninterventional problem-solving procedures shall have radiographic magnification capability available for use by the operator. Systems used for magnification procedures shall provide, at a minimum, at least one magnification value within the range of 1.4 to 2.0. When more than one focal spot is provided, the system shall indicate, prior to exposure, which focal spot is selected. When more than one target material is provided, the system shall indicate, prior to exposure, the preselected target material. When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall display, after the exposure, the target material and/or focal spot actually used during the exposure. Each system shall provide an initial power-driven compression activated by hands-free controls operable from both sides of the patient. Each system shall provide fine adjustment compression controls operable from both sides of the patient. Systems shall be equipped with different sized compression paddles that match the sizes of all full-field image receptors provided for the system. Compression 8(ii)(B) Compression paddle shall be flat and parallel to the breast support table and shall not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied. paddle Equipment intended by the manufacturer s design to not be flat and parallel to the breast support table during 8(ii)(C) compression shall meet the manufacturer s design specifications and maintenance requirements. 8(ii)(D) Chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor. 8(ii)(E) Chest wall edge may be bent upward to allow for patient comfort but shall not appear on the image. 9(i) Manual selection of mas or at least one of its component parts (ma and/or time) shall be available. The technique factors (kvp and either ma and seconds or mas) to be used during an exposure shall be Technique factor 9(ii) indicated before the exposure begins, except when AEC is used, in which case the technique factors that are set selection and prior to the exposure shall be indicated. display Following AEC mode use, the system shall indicate the actual kvp and mas (or ma and time) used during the 9(iii) exposure. Lighting** 14 The facility shall make special lights for film illumination, i.e., hot-lights, capable of producing light levels greater than that provided by the view box, available to the interpreting physicians. Film masking Film masking devices that can limit the illuminated area to a region equal to or smaller than the exposed portion 15 devices** of the film are available to all interpreting physicians interpreting for the facility. Beam quality Must meet the specifications of FDA's erformance Standards for Ionizing Radiation Emitting roducts (art * assessment ) kvp accuracy & * The mean kvp must not differ from the nominal by more than + 5% of the nominal kvp. reproducibility * The coefficient of variation must be * If sum of left plus right edge deviations or anterior plus chest edge deviations exceeds 2% of SID, seek service adjustment. Collimation If X-ray field exceeds image receptor at any side by more than + 2% of SID or if X-ray field falls within image * assessment receptor on the chest wall side, seek service adjustment. * If chest-wall edge of compression paddle is within the image receptor or projects beyond the chest-wall edge of the image receptor by more than 1% of SID, seek service correction. Overall ass/fail * ACR adoption for MEEs of pertinent sections in FDA Rule (e)(5) that apply to annual testing of screen-film only ** NA is acceptable if 1) no hard copy interpretations are made, 2) no hard copy comparisons are made or 3) for new units at existing facilities if these were previously evaluated and have not changed Meets? /No/NA ass Medical hysicist's Section 6. M FORMS - Final_ Sample

3 2. ACR DM hantom Image Quality MA ID-Unit# ( ) ACR DM hantom Mfr and S/N Sunbeam 333 Survey Date August 29, 2016 hantom Setup Equipment: ACR DM hantom (required) hantom Setup: AEC mode: Follow procedure in the Technologist's ACR Technique & rocedure Summaries: addle size (IR size): Use clinical technique for typical screening exam of 4.2 cm 50/50 breast addle type (reg or flex): Largest IR & paddle, 5 dan or 12 lbs, Score on AW View or selected image: Adjust W/L to optimize test objects, zoom & pan entire image Compression force: For Config 2 & 3 using kvp & mas closest to phantom techniques AEC cell position (if avail): hantom patient name: Test Target/filter (if app): Mo/Rh kvp (if app): hantom patient ID: Test Density setting (if app): Image sent to which ACS? Main Mag factor (mag mode only): AO STD 24x30 flex LCC 5 dan Center Resulting Techniques (if available) ACR DM hantom Evaluation SNR & CNR Raw Image Distance Measurement Analysis Fibers Specks Masses Full oint 8 mm long 4-6 specks ¾ border Contact Mode Manual - Target/Filter Config 2 Target/filter Rh/Rh Image receptor size large kvp 29 mas 42.0 Unit-indicated AGD (mgy) 0.96 Artifacts /F Fiber score 4.0 Speck group score 6.0 Mass score 4.0 hantom /F DC offset (if applicable) Mean cavity signal Mean background signal Std dev of background 10.6 Calculated SNR Calculated CNR 4.19 SNR 40.0 (/F) CNR 2.0 (/F) 4.17 arallel to A-C axis (mm) 74.9 Meas = 70.0 ±14.0 mm (/F) Overall ass/fail Half oint 5 & <8 mm 2-3 specks ½ & < ¾ border Clinical - ACR DM hantom CNR from revious Year (if avail; does not apply to MEEs) Manual - Target/Filter Config 3 CNR Lower Limit (85% of Y) 3.5 CNR -15% of revious Year (/F) Initiated (or updated) technologist's ACR Technique and rocedure Summaries form Distance ass Clinical - ACR DM hantom Mo/Rh 19x Mag Mode Manual - Target/Filter Config 2 Manual - Target/Filter Config 3 ACR DM hantom image must be free of clinically significant artifacts. Fiber score must be 2.0; speck group score must be 3.0; mass score must be 2.0. MEE & Annual: SNR must be 40.0; CNR 2.0. Annual: CNR must be 85% of previous year. Measured wax insert distance must be 70.0 ± 14.0 mm. Failures of required items must be corrected before clinical use. Medical hysicist's Section 6. M FORMS - Final_ Sample

4 3. Spatial Resolution MA ID-Unit# ( ) Survey Date August 29, 2016 rocedure Equipment: ACR DM hantom, line-pair test tool hantom Setup: lace ACR DM hantom reversed on breast support (wax insert away from chest edge) addle size (IR size): lace bar pattern on top of phantom and under paddle at ~45 o addle type (reg or flex): Lightly compress paddle to touch bar pattern Acquire "raw" images using manual mode closest to ACR DM hantom technique large flex Contact Mode Mag Mode Mag factor Contact 1.5 Setup Techniques Target/filter kvp mas Rh/Rh Mo/Rh Spatial Resolution Score Line-pair score Overall ass/fail ass ass Spatial resolution must be 4.0 lp/mm for contact mode and 6.0 lp/mm for magnification mode. Failures must be corrected within 30 days. ~45 o Chest Edge Medical hysicist's Section 6. M FORMS - Final_ Sample

5 4. Automatic Exposure Control System erformance MA ID-Unit# ( ) Survey Date August 29, 2016 rocedure Equipment: 2, 4, 6 cm of BR-12, BR-50 or acrylic hantom Setup: addle size (IR Size): Install small paddle (reg or flex) (Use large if small not available) addle type (reg or flex): Use regular or flex paddle used for most clinical imaging AEC cell position (if avail): Set thickness at actual thickness of phantom (2, 4, or 6 cm) Mag setting: Acquire images using clinical techniques Mfr DC offset, if app: SNR data must be obtained from raw image Other settings: large flex center 1.5 AEC Thickness Tracking Setup Techniques Resultant Techniques Signal and Noise Measurements Mode Contact Thickness (cm) 2 AEC Mode AO STD Density setting 0 Target/ Filter Mo/Mo kvp 26 mas 29 Indicated AGD (mgy) 0.90 Mean Bkgd Signal Std Dev of Bkgd 10.5 DC Offset (if app) SNR Contact 4 AO STD 0 Mo/Rh Contact 6 AO STD 0 Rh/Rh Mag 4 AO STD 0 Mo/Rh Analysis Mode Thickness (cm) Contact 2 Contact 4 Contact 6 Mag 4 SNR Lowest Limit for SNR 40.0 MEE and Annual ass/fail revious Year (Y) SNR Annual SNR Lower Limit (85% of Y) SNR -15% of Y (/F) Overall ass/fail ass MEE and Annual: SNR must be 40.0 for 4.0 cm in contact mode. Annual: SNR must be -15% of previous year over the clinically used phantom thickness and imaging modes. Failures must be corrected within 30 days. Medical hysicist's Section 6. M FORMS - Final_ Sample

6 5. Average Glandular Dose MA ID-Unit# ( ) ACR DM hantom Mfr & S/N Sunbeam 333 Survey Date August 29, 2016 rocedure Equipment: Dosimeter Dosimetry system: Use the technique from the ACR DM hantom image page. Calibration date: Measure mr/mas or total exposure for dose calculation(s). Correction factor, if app: Make exposure measurements at 4.2 cm SID (cm): Apple /31/ Technique Factors Resulting From ACR DM hantom Acquisition Exposure Data (at skin surface) AGD Calculation D = Kgcs hantom Breast thickness (cm) ACR DM hantom material AEC mode Target/filter kvp mas Measured HVL (mm Al) mas Setting for Manual Exposure Measurement Exposure #1 (mr) Exposure #2 (mr) Exposure #3 (mr) Average Exposure (mr) Total Exposure (mr) Average Entrance Exposure - K (mr) g-factor x c-factor x (8.76 mgy/r) s-factor Computed AGD (mgy) ACR DM hantom 4.2 Acrylic AO STD Rh/Rh #DIV/0! #DIV/0! #DIV/0! #DIV/0! AGD Result ass/fail ass Indicated vs. Calculated AGD (if avail) Unit-indicated AGD from DM hantom Image (mgy) % Difference Indicated within ±25% of measured? % ass Recommended: AGD for a single cranio-caudal view of the ACR DM hantom must not exceed 3.0 mgy. If available, unit-indicated AGD should be within ±25% of calculated AGD. Doses >3 mgy must be corrected before clinical use; failures of the unit-indicated AGD must be corrected within 30 days. Medical hysicist's Section 6. M FORMS - Final_ Sample

7 6. Unit Checklist MA ID-Unit# ( ) Survey Date August 29, 2016 rocedure Equipment: None Inspect the unit and evaluate the functionality according to the checklist below Item 1. Free-standing unit is mechanically stable.* 2. All moving parts move smoothly, without obstructions to motion. 3. All locks and detents work properly.* 4. Image receptor holder assembly is free from vibrations.* 5. Image receptor slides smoothly into holder assembly (CR). 6. Image receptor is held securely by assembly in any orientation (CR).* 7. atient or operator is not exposed to sharp or rough edges, or other hazards.* 8. addles are all intact with no cracks or sharp edges.* 9. Mammography area is clean and free from significant dust and debris that may cause artifacts. 10. Operator protected during exposure by adequate radiation shielding.* 11. All indicators working properly. 12. Autodecompression can be overridden to maintain compression (and status displayed).* 13. Manual emergency compression release can be activated in the event of a power failure.* 14. Is the audible exposure indicator at an appropriate volume level? 15. Operator technique charts are current and posted. 16. Other: 17. Other: 18. Other: Overall ass/fail /No/NA ass All items, both critical (*) and noncritical, must pass. Failures of critical items (*) must be corrected before clinical use; less critical items must be corrected within 30 days. Medical hysicist's Section 6. M FORMS - Final_ Sample

8 7. Computed Radiography (if applicable) MA ID-Unit# ( ) CR Room Main CR Reader Survey Date August 29, 2016 CR Serial Number Medical hysicist Jane Incredible, hd CR Date of Manufacture January 6, 2016 Signature Inter-late Consistency & Artifact Evaluation rocedure Equipment: ACR DM hantom AEC mode: AO STD AEC detector position: ACR DM hantom on breast support plate with associated paddle. Target/filter: Auto-Time, Set kv to ACR DM hantom kv, cell position 2 if available. kvp: center Mo/Rh 28 Small Cassettes mas Evaluation SNR Evaluation (if available) Artifact Overall Cassette ID mas /F Signal Std Dev SNR /F ass/fail ass/fail ass ass ass ass 5 F F Fail 6 F F Fail 7 8 F F F F Fail Fail Minimum mas: Mean mas: Maximum mas Allowable Minimum SNR: Mean SNR: Maximum SNR Allowable Small Cassettes mas Evaluation SNR Evaluation (if available) Artifact Cassette ID mas /F Signal Std Dev SNR /F ass/fail ass ass ass ass 5 F F Fail 6 F F Fail 7 F F Fail 8 F F Fail Allowable Allowable Minimum mas: Minimum SNR: Mean mas: Mean SNR: Maximum mas Maximum SNR Overall ass/fail mas must be within ±10% of average mas. SNR must be within ±15% of average SNR. Must be free of clinically significant artifacts. Failures must be corrected before clinical use. Medical hysicist's Section 6. M FORMS - Final_ Sample

9 7. Computed Radiography (if applicable, continued) MA ID-Unit# ( ) Survey Date August 29, 2016 CR Reader Scanner erformance rocedure Equipment: 2 thin metal rulers (or equivalent). lace rulers in the shape of a T on a cassette which is placed on top of the breast support. Expose at extremely low manual technique (~25 kvp, 4 mas). arallel to Chest Wall erpendicular to Chest Wall ass/fail ass ass Recommendation: The edges of the "T" should appear smooth and sharp. If they are not, and appear jagged or nonsmooth, then this could indicate a problem with the CR reader performance. Breast Support Cassette Ruler Ruler Medical hysicist's Section 6. M FORMS - Final_ Sample

10 8. Acquisition Workstation (AW) Monitor QC MA ID-Unit# ( ) Medical hysicist Jane Incredible, hd Survey Date August 29, 2016 Signature rocedure Equipment: Luminance meter Note: Some of these QC tests may or may not be possible to perform depending on the monitor QC capabilities Test attern Image Quality: Use TG18-QC, SMTE or other relevant pattern (if available) Luminance Check: TG 18 LN8-01 & LN8-18 test patterns, or others that provide measure of L min & L max (if available) Monitor manufacturer: Volkswagon Model: Bright Monitor serial number Monitor date of manufacture Monitor Condition Significant findings /F Test pattern centered appropriately? 0%-5% contrast boxes visible? 95%-100% contrast boxes visible? Alphanumerics sharp and legible? 3 "Quality Control" patches visible (TG18)? Line-pair images distinct (center)? Line-pair images distinct (corners)? Grayscale ramps smooth (if avail)? Test pattern /F Measured Luminance minimum (cd/m 2 ) Mfr recommendation for L min (if avail) L min meets mfr recommendation ±30%? Test attern Image Quality (if available) Luminance Check (if available) DICOM GSDF Measured Luminance maximum (cd/m 2 ) Mfr recommendation for L max (if avail) L max meets mfr recommendation ±10%? Luminance check /F W/in ±10% of targeted contrast response /F (if avail) /12/ Significant findings indicated on figure below Luminance Uniformity Center Upper Left Upper Right Lower Left Lower Right Max Min Mfr Automated Test Most recent set of mfr automated tests /F % Diff 3.3 Overall ass/fail ass /F Any identified screen blemish that could interfere with clinical information must be removed. Test pattern image quality must pass all visual tests. L min must be within ±30% of mfr specifications (or, if not available 1.5 cd/m 2 ). L max must be within ±10% of mfr specifications (or, if not available 150 cd/m 2 ). Luminance uniformity must be 30% GSDF measured contrast response must be within ±10% of targeted contrast response. Mfr's automated tests must pass mfr specifications (if 1 test fails, indicate "F"). Significant monitor cleanliness defects must be corrected before clinical use; all other required tests must be corrected within 30 days. Medical hysicist's Section 6. M FORMS - Final_ Sample

11 9. Radiologist Workstation (RW) Monitor QC MA ID-Unit# ( ) Workstation ID RW ID#4 Survey Date August 29, 2016 Medical hysicist Jane Incredible, hd Signature rocedure Equipment: ACR DM hantom Image, luminance meter Note: Some of these QC tests may or may not be possible to perform depending on the monitor QC capabilities ACR DM hantom: use phantom acquired from any DM within facility network, preferably one M has acquired Test attern Image Quality: Use TG18-QC, SMTE or other relevant pattern Luminance: TG 18 LN8-01, LN8-18 & TG 18 UNL80 test patterns or other relevant test patterns ACR DM hantom Evaluation Test attern Image Quality Luminance Check Monitor manufacturer: Volkswagon Model: Brighter Monitor serial number Monitor date of manufacture Ambient Light Are ambient light conditions adequate for DM? Monitor Condition Significant findings /F Artifacts /F Fiber score Speck group score Mass score hantom /F arallel to A-C axis (mm) Distance Measurement Meas = 70.0 ±14.0 mm (/F) Test pattern centered appropriately? 0%-5% contrast boxes visible? 95%-100% contrast boxes visible? Alphanumerics sharp and legible? 3 "Quality Control" patches visible (TG18)? Line-pair images distinct (center)? Line-pair images distinct (corners)? Grayscale ramps smooth? Test pattern /F Measured Luminance minimum (cd/m 2 ) Mfr recommendation for L min (if avail) L min meets mfr recommendation ±30%? Measured Luminance maximum (cd/m 2 ) Mfr recommendation for L max (if avail) L max meets mfr recommendation ±10%? Luminance check /F DICOM GSDF (if avail) Mfr Automated Test W/in ±10% of targeted contrast response /F Most recent set of mfr automated tests /F Overall ass/fail Left* Right* /1/2010 8/1/ ass ass Significant findings indicated on figures below *Left and right monitors; complete additional forms if more than 2 monitors used Luminance Uniformity Monitor Center Upper L Upper R Lower L Lower R Max Min % Diff /F Left Right Luminance Matching /F Recommended: Any identified monitor blemish that could interfere with clinical information must be removed. ACR DM hantom image must be free of clinically significant artifacts. Fiber score must be 2.0; speck group score must be 3.0; mass score must be 2.0. Measured distance of wax insert must be 70.0 ±14.0 mm. Test pattern image quality must pass all visual tests. L min must be within ±30% of mfr specifications (or, if not available 1.5 cd/m 2 ). L max must be within ±10% of mfr specifications (or, if not available 420 cd/m 2 ). Luminance uniformity must be 30%; luminance matching must be 20%. GSDF measured contrast response must be within ±10% of targeted contrast response. Mfr's automated tests must pass mfr specifications (if 1 test fails, indicate "F"). Ambient light conditions should be appropriate for mammography; max of 45 lux is recommended. hantom must pass and significant monitor cleanliness defects must be corrected before clinical use; all other required tests must be corrected within 30 days. Medical hysicist's Section 6. M FORMS - Final_ Sample

12 10. Film rinter QC (if applicable) MA ID-Unit# ( ) rinter ID rinter #1 Survey Date August 29, 2016 Medical hysicist Jane Incredible, hd Signature rocedure Applicability: If film printer is used clinically for mammography (i.e., for interpretation and to provide images to referring physicians and patients) Equipment: Densitometer rint an ACR DM hantom image acquired from any DM unit within facility network, preferably one M has just acquired. Do not change window/level settings from acquired image prior to printing. rint the phantom image from the workstation/computer typically used to print clinical films. Dmax should be measured either at extreme left or right edge of film or at extreme non-chest wall edge. Film rinter Manufacturer Suzuki Film rinter Serial Number Film rinter Model Fast Film rinter Date of Manufacture 9/1/2013 Workstation for printing RW ID#4 DM ID or workstation ID Film size 8 x 10 Artifacts /F ACR DM hantom Fiber score Speck group score Mass score hantom /F F Background Bkgd OD (Outside cavity) Bkgd OD 1.6 (/F) 1.72 F Cavity OD 1.88 Contrast Bkgd OD (use value from above) Contrast = Cavity OD - Bkgd OD Contrast 0.1 (/F) F D max D max OD D max OD 3.1 (/F) 3.62 F Distance Measurement arallel to A-C axis (mm) Meas = 70.0 ±14.0 mm (/F) 71.5 F Overall ass/fail ass Fail ACR DM hantom image must be free of clinically significant artifacts. Fiber score must be 2.0; speck group score must be 3.0; mass score must be 2.0. Background OD must be 1.6 (1.7 to 2.2 is recommended; approx 2.0 is optimal). Contrast (Cavity OD - Background OD) must be 0.1. D max must be 3.1 ( 3.5 is recommended). Measured distance of wax insert must be 70.0 ±14.0 mm. Failures of required items must be corrected before printing of clinical images. Medical hysicist's Section 6. M FORMS - Final_ Sample

13 11. Evaluation of Site's Technologist QC rogram MA ID-Unit# ( ) Survey Date August 29, 2016 Radiologic Technologist's Quality Control Tests 1. ACR DM hantom Image Quality Frequency Weekly Test erformed, Analyzed & Documented Missing Data Incorrect Scoring or Calculations Missing Corrective Action Documentation Other Comments Scores of latest phantom image: Fiber Latest QC Tech Score 4.0 Med hys Score 4.0 Speck group Mass CR Cassette Erasure (if app) 3. Comp Thickness Indicator 4. Visual Checklist 5. AW Monitor QC 9. Facility QC Review 10. Compression Force 11. Mfr Detector Calibration (if app) Optional - Repeat Analysis Optional - System QC for Radiologist Optional - Radiologist IQ Feedback Corrective Action Log documentation adequate? Additional Comments: Great job, Sue! Weekly Monthly Monthly Monthly Quarterly Semiannual As Needed NA NA Overall ass/fail for erformance of Technologist QC rogram ass MQSA regulations [FDA Rule (d)(1)(iii) specify that "each facility shall have the services of a medical physicist available to survey mammography equipment and oversee the equipment-related quality assurance practices of the facility. " Completion of this "Evaluation of Site's Technologist QC rogram" form documents that this oversight has been conducted. In order for the overall evaluation to pass, there must be a) no significant missing data, b) the tests must be analyzed without gross errors, and c) appropriate corrective action for failures must be taken (and documented). See test procedures for more information. Failures must be corrected within 30 days. Medical hysicist's Section 6. M FORMS - Final_ Sample

14 12. Evaluation of Display Device Technologist QC rogram MA ID-Unit# ( ) Medical hysicist Jane Incredible, hd Display Device Location Main Signature Survey Date August 29, 2016 Display Device ID & Room Example: Mammography reading room Display Device Description (RW, rinter, Viewbox) RW Test erformed, Analyzed & Documented Incorrectly Missing Data Incorrect Scoring or Calculations Missing Corrective Action Documentation Mfr Automated Tests (if Applicable) Other Comments Discussed with manager /F Rad Read East RW Rad Read West RW Main 2 RW Corrective Action Log documentation adequate? Overall ass/fail for erformance of Display Device Technologist QC rogram ass Additional Comments: MQSA regulations [FDA Rule (d)(1)(iii) specify that "each facility shall have the services of a medical physicist available to survey mammography equipment and oversee the equipment-related quality assurance practices of the facility. " Completion of this "Evaluation of Site's Technologist QC rogram" form documents that this oversight has been conducted. In order for the overall evaluation to pass, there must be a) no significant missing data, b) the tests must be analyzed without gross errors, and c) appropriate corrective action for failures must be taken (and documented). See test procedures for more information. Failures must be corrected within 30 days. Medical hysicist's Section 6. M FORMS - Final_ Sample

15 MEE or Troubleshooting Beam Quality (Half-Value Layer) Assessment MA ID-Unit# ( ) Survey Date August 29, 2016 rocedure Equipment: Dosimeter, 0.1 mm Al sheets, lead sheet Dosimetry system: Cover the detector with lead sheet or apron Calibration date: Make at least 1 measurement for each available target-filter combination Apple 1010 August 31, 2016 DM hantom Target/Filter 1 Target/Filter 2 Target/Filter 3 Target/filter Rh/Rh Mo/Mo Mo/Rh Nominal kvp setting mas Exposure Measurements mm AL X (mr) mm AL X (mr) mm AL X (mr) mm AL X (mr) mm AL X (mr) mm AL X (mr) No Aluminum E Al Thickness (mm) t a 0.5 E a Al Thickness (mm) t b E b Calculated or measured HVL (mm Al) #DIV/0! #DIV/0! #DIV/0! Minimum allowed HVL Overall ass/fail ass ass ass #DIV/0! #DIV/0! #DIV/0! HVL = t b ln[2e a /E 0 ] - t a ln[2e b /E 0 ] ln [E a /E b ] The HVL must meet the specifications of FDA's erformance Standards for Ionizing Radiation Emitting roducts (art ) as shown below. All failures must be corrected before clinical use. FDA X-ray Tube Voltage (kilovolt peak) and Minimum HVL Designed Operating Range (kv) Below 50 Measured Operating Voltage (kv) Minimum HVL (mm of Al) Medical hysicist's Section 6. M FORMS - Final_ Sample

16 MEE or Troubleshooting kvp Accuracy and Reproducibility MA ID-Unit# ( ) Survey Date August 29, 2016 kvp Accuracy and Reproducibility rocedure Equipment: kvp meter, lead sheet Cover the entire detector with lead sheet, a lead apron or other device. Remove the paddle. kvp meter Sanyo Volt Calibration Date: 9/1/2016 Setting Low Clinical kvp ACR DM hantom Clinical kvp High Clinical kvp Technique Nominal kvp setting Target/filter Focal spot mas 24 Mo/Mo Rh/Rh Rh/Rh Measured kvp value Data Measured kvp value 2 Measured kvp value Mean kvp Standard deviation (SD) Mean kvp - nominal kvp Analysis 0.05 x nominal kvp % error % error /F % % % Coefficient of variation (CV) 0.0 CV /F Overall ass/fail ass ass ass Mean kvp must not differ from the nominal by more than ±5% of the nominal kvp. Coefficient of variation must be When test is for MEE, all failures must be corrected before clinical use. When test is for troubleshooting, all failures must be corrected within 30 days. Medical hysicist's Section 6. M FORMS - Final_ Sample

17 MEE or Troubleshooting Collimation Assessment MA ID-Unit# ( ) Survey Date August 29, 2016 rocedure Equipment: Coins, film, electronic collimation test tool(s), etc. Eqpt used: coins kvp: 24 mas: 5 Largest Detector Size Available Small Detector Size (CR only) Technique Target material Collimator size (cm) SID (mm) Molybdenum 24x Deviation Between X-ray Field and Light Field Left edge deviation (mm) Right edge deviation (mm) Sum of left and right edge deviations Sum as % of SID Anterior edge deviation (mm) Chest edge deviation (mm) Sum of anterior and chest edge deviations Sum as % of SID ass/fail Deviation Between X-ray Field and Edges of the Image Receptor Left edge deviation % of SID (retain sign) Right edge deviation % of SID (retain sign) Anterior edge deviation % of SID (retain sign) Chest edge deviation % of SID (retain sign) ass/fail Alignment of Chest-Wall Edges of Compression addle and IR Difference between paddle edge and film Difference as % of SID ass/fail Overall ass/fail ass If sum of left plus right edge deviations or anterior plus chest edge deviations exceeds 2% of SID, seek service adjustment. If X-ray field exceeds image receptor at any side by more than +2% of SID or if X-ray field falls within image receptor on the chest wall side, seek service adjustment. If chest-wall edge of compression paddle is within the image receptor or projects beyond the chest-wall edge of the image receptor by more than 1% of SID, seek service correction. When test is for MEE, all failures must be corrected before clinical use. When test is for troubleshooting, all failures must be corrected within 30 days. Medical hysicist's Section 6. M FORMS - Final_ Sample

18 Troubleshooting Ghost Image Evaluation MA ID-Unit# ( ) Survey Date Happy Valley Mammography rocedure Equipment: ACR DM hantom, 0.1 mm Al sheet (10 cm x 10 cm) hantom Setup Largest image receptor size addle Size (IR size) : Clinical paddle (reg or flex) addle Type (reg or flex) : Apply 5 dan or 12 lbs comp force Exposure Mode: Compression Force: osition ACR DM hantom with wax insert opposite from chest wall edge. AEC Cell osition (if avail) : AEC cell position to position "3". Density Setting: Use clinical (AEC) technique for both images Image 1: osition phantom like Setup Image #1 (edge extends 1" beyond midline). Image 2: osition phantom like Setup Image #2 with Al placed on top. Signal data must be obtained from raw image large flex AO STD 12 lbs or 5 dan Image 1 Image 2 Resulting Techniques from Image Acquisition Target/filter kvp mas Rh/Rh Rh/Rh Ghosting Analysis (see images below) S 1 S 2 S 3 Ghosting Index Overall ass/fail ass Ghosting Index = (S 3 - S 2 ) (S 1 - S 2 ) The ghosting index must be within 0±0.3. Failures must be corrected before clinical use. Setup Image 1 Setup Image 2 Evaluation Image S 1 S 2 S 3 Image 2 Image 1 Medical hysicist's Section 6. M FORMS - Final_ Sample

19 Troubleshooting Viewbox Luminance MA ID-Unit# ( ) Medical hysicist Jane Incredible, hd Viewbox Location Main Office Signature Survey Date August 29, 2016 rocedure Equipment: Luminance meter Measure luminance for all viewboxes, record the luminance value for the viewbox with the lowest luminance. Note: Only check a deficiency if it is significant and could impact interpretation; if the observation is not significant, just make a note in comments Measurements Significant Deficiencies 1. Viewbox Designation Hallway - 1 Viewbox Luminance (cd/m 2 ) 3010 Dirt and Marks Color Difference Luminance Difference Non-Uniformity Functioning Masks Missing ass/fail 2. Hallway Tech QC Review for Viewbox Luminance Overall ass/fail ass Comments: Recommended: Mammography viewboxes should be capable of a luminance of 3,000 cd/m 2, be uniform, clean and have functioning masks; if these are not met, corrective action should be taken. Medical hysicist's Section 6. M FORMS - Final_ Sample

20 Medical hysicist's DM QC Test Summary Facility Name Happy Valley Mammography Address Suite 1 1 Oak Street Anywhere ST Survey Date Report Date Date of revious Survey August 29, 2016 August 31, 2016 July 16, 2015 MA ID Unit# ( ) Months Between Surveys 13 (must be 14) X-Ray Unit Manufacturer Ford X-Ray Unit Model Imager X-Ray Unit Control Serial # it Date of Manufacture January 3, 2015 Date of Installation X CR Unit Mfr 5000 CR Unit Model CR Unit Serial # Medical hysicist Jane Incredible, hd Telephone (444) Signature Quality Control Manual Used for Survey and Facility QC: 2015 ACR Digital Mammography Quality Control Manual Survey Type: Mammography Equipment Evaluation (MEE) - Acceptance Testing Routine Annual Survey Equipment Tested: DM Unit AW Monitor RW Monitor Viewbox rinter Other M Oversight Level: Medical hysicist On-Site Medical hysicist Oversight Unit Description: Digital radiography (DR) Computed Radiography (CR) Tomosynthesis (DBT) Unit Use: Diagnostic & Screening Diagnostic Only Screening Only ("ass" means all components of test passes; "Fail" means any or all components fail; if "CA" checked, see Corrective Action Summary) Overall Overall Medical hysicists Tests ass/fail/na CA Tech QC Evaluation ass/fail/na CA 1. Mammography Equip Eval (MEE) ass 1. ACR DM hantom Image Quality ass 2. ACR DM hantom Image Quality ass 2. CR Cassette Erasure (if app) ass 3. Spatial Resolution ass 3. Comp Thickness Indicator ass 4. AEC System erformance ass 4. Visual Checklist ass 5. Average Glandular Dose ass 5. AW Monitor QC ass 6. Unit Checklist ass 6. RW Monitor QC ass 7. Computed Radiography (if app) ass 7. Film rinter QC (if app) ass 8. AW Workstation Monitor QC ass 8. Viewbox Cleanliness (if app) ass 9. RW Monitor QC ass 9. Facility QC Review ass 10. Film rinter QC (if app) ass 10. Compression Force ass 11. Site's Tech QC rogram ass 11. Mfr Detector Calibration (if app) ass 12. Display Device Tech QC rogram ass Optional - Repeat Analysis ass MEE or Troubleshooting Beam Quality (HVL) Assessment kvp Accuracy and Reproducibility Collimation Assessment Ghost Image Evaluation Viewbox Luminance Medical hysicist's QC Tests Overall ass/fail/na ass ass ass ass ass CA ACR DM hantom Summary Value Limit Fiber score Speck group score Mass score SNR CNR AGD (mgy) Medical hysicist's Section 6. M FORMS - Final_ Sample

21 Medical hysicist's DM QC Test Summary Medical hysicist's QC Tests (continued) MA ID-Unit# ( ) Survey Date August 29, Corrective Action Summary* *Note: This is only a summary page, the Corrective Action Log Form may contain further details. Required/ Recommended Time Frame Description Utilize Corrective Action Log Form Date Completed Initials Medical hysicist's Section 6. M FORMS - Final_ Sample

22 Mammography Technique Chart MA ID-Unit# ( ) Survey Date August 29, 2016 Screening/Diagnostic Mammography Compressed Breast Thickness <3 cm 50% Fatty - 50% Dense Breast AEC Mode Target/Filter kvp AO STD Mo/Mo 26 3 to 5 cm AO STD Mo/Rh 27 5 to 7 cm AO STD Rh/Rh 30 > 7 cm AO STD Rh/Rh. 32 Implant Displaced Mammography Views (Manual Technique) Target/Filter kvp mas Small Mo/Rh Medium Mo/Rh Large Rh/Rh ACR DM hantom Technique (Weekly QC) AEC mode AO STD addle size (IR Size) addle type (reg or flex) View/selected image type Compression force AEC cell position (if avail) Target/filter (if app) kvp (if app) Density setting (if app) 24x30 flex LCC 5 dan Center Rh/Rh Medical hysicist's Section 6. M FORMS - Final_ Sample

23 Medical hysicist QC Letter for the Radiologist Dr. Mary Awsome Happy Valley Mammography Suite 1 1 Oak Street Anywhere ST August 31, 2016 Re: Medical hysicist Survey of on August 29, 2016 Dear Lead Interpreting Radiologist, The above mammography unit at your facility recently underwent an Annual Medical hysics Survey. Below is the relevant summary information as a result of this survey. lease note that your facility must follow-up on the Action Items below and obtain relevant documentation from the service engineer. lease evaluate the ACR Digital Mammography hantom image acquired during the medical physicist testing (Image ID information listed below) and see my comments. If you have any questions please don't hesitate to call. Image Quality atient Name (hantom): atient ID (hantom): Date: Test Test 8/29/2016 Fiber score Speck group score Mass score Artifacts ACR Digital Mammography hantom Scores Your Unit assing Criteria ass /Fail No Clinically Significant Artifacts Comments on phantom image: Radiation Dose ACR hantom Dose (mgy) Note: The above dose is an estimate determined with a phantom representing the FDA-defined 4.2 cm thick, 50% glandular/50% adipose standard breast. Doses will vary with patient size and density. Specific patient doses can be estimated by your medical physicist. Comments on radiation dose: ACR Digital Mammography hantom Radiation Dose Values Your Unit assing Criteria ass /Fail Medical hysicist's Section 6. M FORMS - Final_ Sample

24 Medical hysicist QC Summary Letter for the Radiologist, Cont'd Required Action Items Time Frame Description Recommended Action Items Time Frame Description Comments on Monitors, Monitor QC, & Viewing Conditions Time Frame Description Comments on Tech QC Time Frame Sue does an excellent job! Description If you have any questions, please do not hesitate to call. Sincerely, Jane Incredible, hd hone (444) Medical hysicist's Section 6. M FORMS - Final_ Sample