c) ≥25 per 10,000 women aged 50–69 years who attend for screening are diagnosed with small (≤15mm) invasive breast cancer. c) The number of women aged 50–69 years who attend for screening who are diagnosed with small (≤15mm) invasive breast cancer per 10,000 women screened. Calculation: See Data Dictionary a) The Service and/or SCU monitors and reports the proportion of women aged 50–74 years who attend annually for screening, who are diagnosed with invasive breast cancer. b) The Service and/or SCU monitors and reports the proportion of women aged 50–74 years who attend annually for screening, who are diagnosed with small (≤15mm) invasive breast cancer. c) The Service and/or SCU monitors and reports the proportion of women aged 40–49 years who attend annually for screening, who are diagnosed with invasive breast cancer. 2 a) The number of women aged 50–74 years who attend annually for screening who are diagnosed with invasive breast cancer per 10,000 women screened. b) The number of women aged 50–74 years who attend annually for screening who are diagnosed with small (≤15mm) invasive breast cancer per 10,000 women screened. c) The number of women aged 40–49 years who attend annually for screening who are diagnosed with invasive breast cancer per 10,000 women screened. Calculation: See Data Dictionary 2.2 The Service and/or SCU maximises the detection of ductal carcinoma in situ (DCIS). a) The Service and/or SCU monitors and reports the proportion of women aged 50–74 years who attend for their first screening episode who are diagnosed with DCIS. b) ≥12 per 10,000 women aged 50–69 years who attend for their first screening episode are diagnosed with DCIS. 2 a) The number of women aged 50–74 years who attend for their first screening episode who are diagnosed with DCIS per 10,000 women screened. b) The number of women aged 60–69 years who attend for their first screening episode who are diagnosed with DCIS per 10,000 women screened. Calculation: See Data Dictionary a) The Service and/or SCU monitors and reports the proportion of women aged 50–74 years who attend for 2 a) The number of aged 50–74 years who attend for their second or subsequent screening episode who are diagnosed with DCIS per 10,000 women screened.
TABLE E.3: QUALITY CONTROL PROCEDURES AND STANDARDS FOR CR MAMMOGRAPHY Procedure Control-Limits/Requirements Minimum Frequency Required Procedure Elements Minimum Record Requirements Viewing conditions Appropriate viewing conditions All viewbox lamps must be operational and appropriate masking available (if applicable) Visual inspection of ambient lighting conditions to ensure conformance with acceptable viewing condition configuration. Refer to corresponding text in the ACPSEM Position Paper V3.0 for detail. Visual inspection of viewboxes for uniformity of brightness. Confirmation of presence and operation of masking for viewboxes. Records confirm: Date performed. Person performing task. Image plate erasure Erasure of energy absorbed from scattered radiation or naturally occurring radiation by CR image plates before they are used. On a daily basis or if left unused for more than 8 hours, all CR image plates should be subjected to a secondary erasure (following manufacturer’s instructions). On a weekly all CR image plates should be subjected to a primary erasure (following manufacturer’s instructions). Records confirm: Date performed. Person performing task. Monitor/ Viewbox cleaning Monitor screens and viewboxes must be free of dust, fingerprints and other marks that might interfere with image interpretation Weekly Clean all monitor screens and viewboxes gently with lint-free cloth as per manufacturer’s instructions. Records confirm: Date performed. Person performing task
Monitor QC (monitors used for interpretation and attached to the acquisition workstation) Borders must be visible, lines must be straight, squares must appear square, the ramp bars should appear continuous without any contour lines, there should be no smearing or bleeding at transitions, all corner patches must be visible, squares of different shades from black to white must be distinct, all high contrast resolution patterns and two low contrast patterns must be visible in all four corners and in the centre, the 5% and 95% pixel value squares must be clearly visible, pattern should be centred in the active area and no disturbing artefacts should be visible on the displayed TG18-QC test pattern. The number of letters visible in the phrase “Quality Control” for the dark, mid-grey and light renditions should be ≥11. Weekly Display the TG18-QC test pattern. Ensure viewing conditions are acceptable. Use window-width set to maximum and window-level set to half of maximum. Check visibility and distortion of several items used for evaluating the quality of the image. Check for disturbing artefacts. Control chart showing: Date test performed. Person performing test. Monitor identification. Monitor settings (window and level). A record of at least the last 25 results. Baseline values. Remarks regarding corrective actions and baseline changes. Printer area cleanliness (if applicable) Clean and dust free environment Weekly Wet cleaning of printer area floor and open shelves. Inspect and air intake filters on the film printer. Records confirm: Date performed Person performing task
Quality Evaluation - Phantom images mAs = baseline 10% Dose to = baseline 10% Exposure indicator (refer to Appendix 6 of the ACPSEM Position Paper V3.0 for manufacturer dependent tolerances) For hard copy reporting optical density (OD) in the background must be in the of 1.6 to 2.0 and the contrast between the PMMA disc and the background must be ≥ 0.40 OD. Clearly visualize in an image of an ACR accreditation phantom: 5 fibres 3.5 groups ( 4 is desirable) 4 masses. Weekly Obtaining the phantom image: Use of an ACR accreditation phantom. Use a designated QC test cassette and imaging plate that is in routine clinical use. Use of a consistent AEC detector position manually selected. Light contact between the compression paddle and the phantom surface. Consistent positioning of the phantom. Consistent selection of clinically relevant kVp and target/filter combinations. Selection of the density setting in current clinical use. Consistent time between plate irradiation and readout. Evaluating the phantom image (preferably on reading workstation or on printed copy if hardcopy reporting used): Use “for presentation” image with zoom and modest adjustment of window/level functions to score fibres and specks. Record numerical mAs values and image quality scores. Control showing: of mAs, exposure indicator, image quality scores and OD if applicable. A record of at least the last 25 results. Clearly marked control limits. Baseline values. Radiographic settings (kVp, target/filter combination, AEC detector position, density setting and source to image distance (SID)). Remarks regarding corrective actions and baseline changes. Dated phantom images from at least the last six months showing X-ray system and radiographic settings.
Mechanical inspection Indicated breast thickness accurate to ± 5 mm. No hazardous, inoperative, out of alignment or improperly operating items on the system. All items listed on the visual check list (see ACPSEM position paper V3.0) have received a pass. Ensure images are free from excessive artefacts attributable to dust on plates. Monthly Monthly or as recommended by manufacturer Confirm accuracy of thickness indication. Visual inspection of the system to ensure safe and optimum operation. Records showing: Date inspection performed. Inspection results. Person performing test. Image plate cleaning If it is found that plates must be cleaned frequently (certainly more than weekly) this may indicate problems with dust or cleanliness of the imaging environment. If this is the case, attention should be given to ventilation (possible need for improved air filtration in the room and/or the CR plate reader) and room cleaning protocols. Note: Excessive frequency of plate cleaning may lead to premature wear of the plates. Clean plates according to manufacturer’s cleaning protocol. Records showing: Date inspection and cleaning performed Person performing test
Film Digitiser QC (if applicable) Digitised images are produced that consistently and accurately reproduce hard copy images. A plot of MPV versus OD should be linear over full range of OD from B+F to Dmax with R2> 0.95 Note: If the plot of MPV versus OD is not linear, it could be due to the wrong LUT being selected by the equipment. This should be rectified by service personnel. Monthly Produce an analogue film with a step pattern. This may be generated automatically by a laser printer, for example. Measure the Optical Densities (OD) for each step Digitise the image Measure the mean pixel value (MPV) at a convenient place in each step Plot the MPV versus OD using an EXCEL spreadsheet. This should be linear if the correct look up table (LUT) is used. Note: The LUT is part of the software in the digitiser or workstation it is attached to. Obtain the value of the correlation coefficient (R2) using EXCEL for this plot. Date test performed Person performing test The R2 value for the plot of MPV versus OD. Repeat analysis Overall repeat rate ≤2% Quarterly Analysis of the proportion of repeats attributable to positioning, a range of equipment faults and other reasons for the quarter or from at least 250 consecutive client examinations. Records showing: Date analysis was performed. Person performing analysis. Results of analysis and any corrective actions taken.
AEC test Dose to plate for each of 2, 4 and 6 cm PMMA = baseline ±10% to Appendix 6 of the ACPSEM Position Paper V3.0 for equivalent manufacturer specific exposure index requirements. Quarterly Assess for both contact and magnification modes. Use PMMA thickness between 2 and 6 cm covering complete cassette. Use clinical AEC settings (kVp, target/filter and mode including density setting). Use a designated QC test cassette and imaging plate that is in routine clinical use. Use a consistent AEC detector position this is manually selected. Consistent positioning of the PMMA. Consistent time delay between plate irradiation and readout. Records showing: Date test was performed. Person performing test. X-ray system identification and source to image distance (SID). kVp, target/filter, AEC mode and mAs for each phantom thickness. Test results. Compression Maximum motorised compression force in range 150 - 200 newtons and manual compression force less than 300 newtons. Six monthly Confirm machine indicated compression force meets requirements. Records showing: Date test was performed. Person performing test. Test results and any corrective actions taken.
Monitor QC (monitors used for interpretation and attached to the acquisition workstation) Borders must be visible, lines must be straight, squares must appear square, the ramp bars should appear continuous without any contour lines, there should be no smearing or bleeding at transitions, all corner patches must be visible, squares of different shades from black to white must be distinct, all high contrast resolution patterns and two low contrast patterns must be visible in all four corners and in the centre, the 5% and 95% pixel value squares must be clearly visible, pattern should be centred in the active area and no disturbing artefacts should be visible on the displayed TG18-QC test pattern. The number of letters visible in the phrase “Quality Control” for the dark, mid-grey and light renditions should be ≥11. Weekly Display the TG18-QC test pattern. Ensure viewing conditions are acceptable. Use window-width set to maximum and window-level set to half of maximum. Check visibility and distortion of several items used for evaluating the quality of the image. Check for disturbing artefacts. Control chart showing: Date test performed. Person performing test. Monitor identification. Monitor settings (window and level). A record of at least the last 25 results. Baseline values. Remarks regarding corrective actions and baseline changes.
Image Quality Evaluation - Phantom images Clearly visualize in ACR 3 fibres 3 speck groups 2.5 masses or Clearly visualize in RMI 3 fibres 2 groups 1.5 masses Weekly Obtaining the phantom Use of an ACR mini accreditation mammography phantom or equivalent. Light contact between the compression paddle and the phantom surface. Consistent positioning of the phantom. Consistent selection of a clinically relevant kVp and target/filter combination. Selection of the density setting in current clinical use (if applicable). Evaluating the phantom image: Use of consistent viewing conditions that reflect those used to read clinical images. Image quality scoring by the same person, if possible. Use of a control chart to display results. Control showing: Plots against date of mAs and image quality scores. A record of at least the last 25 results. Clearly marked control limits. Baseline values Radiographic settings (kVp, target/filter combination, density setting. Remarks regarding corrective actions and baseline changes. Dated phantom images from at least the last six months showing X-ray system and radiographic settings.
Printer QC (if applicable) Borders must be visible, lines must be straight, all corner patches must be visible, squares of different shades from black to white must be distinct, all high contrast resolution patterns and the two pixel low contrast patterns must be visible in all four corners, the 5% and 95% pixel value squares must be clearly visible, and no disturbing artefacts should be visible on the printed TG18-QC pattern. The number of letters visible in the phrase "Quality Control" for the dark, mid-grey and light renditions should be ≥11 The mid density (MD) and density difference (DD) = baseline 0.15 Base + fog (B+F) = baseline 0.03 and ≤0.25 Dmax = baseline ± 0.10 and ≥3.4 Monthly for dry lasers and daily or as used for wet lasers Print the TG18-QC test pattern. Check visibility and distortion of several items used for evaluating the quality of the image. for disturbing artefacts. Measure MD, DD, B+F and Dmax Control chart showing: Date test performed. Person performing test. Printer identification. Test results. A record of at least the last 25 results. Clearly marked control limits. Remarks regarding corrective actions and baseline changes. Repeat analysis Overall repeat rate ˂20% (ACR, 1999) Six monthly Analysis of the proportion of repeats attributable to positioning, a of equipment faults and other reasons for 6 months or from at least 150 consecutive stereotactic examinations. Records showing: Date analysis performed. Person performing task. Results and any corrective actions.