Mammography 1999
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1999 Mammography QUALITY CONTROL MANUAL Radiologist’s Section Clinical Image Quality Radiologic Technologist’s Section Medical Physicist’s Section 1999 Mammography QUALITY CONTROL MANUAL Radiologist’s Section Clinical Image Section Radiologic Technologist’s Section Medical Physicist’s Section American College of Radiology Committee on Quality Assurance in Mammography R. Edward Hendrick, Ph.D., Chairman Lawrence Bassett, M.D. Margaret A. Botsco, R.T., (R)(M) Debra Deibel, R.T., (R)(M) Stephen Feig, M.D. Joel Gray, Ph.D. Arthur Haus Rita Heinlein, R.T., (R)(M) E. Lee Kitts, Jr., Ph.D. John McCrohan, M.S. Barbara Monsees, M.D. Pamela Wilcox, M.B.A., ACR Staff Member Priscilla F. Butler, M.S., ACR Staff Member Marie Zinninger, M.S.N. © Copyright 1999, American College of Radiology. All rights reserved. Reprinted 2004, 2007 Contents Table of Contents . v Preface . ix Radiologist's Section Introduction . 5 Definitions Of Quality Assurance (Qa) And Quality Control (Qc) . 6 Radiologist’s Responsibilities . 9 Comments . .11 Medical Physicist’s Responsibilities . .13 Comments . .14 Radiologic Technologist’s Responsibilities . .15 Comments . .15 Specimen Radiography . .17 Conclusion . .19 References . .21 Clinical Image Quality Section I . Patient Positioning And Compression . .27 1 . Introduction . 27 2 . Labeling Of Mammograms . .29 3 . Breast Compression . .34 4 . Patient Positioning . .38 5 . Additional Views . 55 6 . Special Circumstances . .72 7 . Postmastectomy Imaging . .81 II . Clinical Image Evaluation . .83 1 . Introduction . .83 2 . Mediolateral Oblique View Positioning . .84 3 . Craniocaudal View Positioning . .91 4 . Compression . .95 5 . Exposure . .97 Mammography Quality Control Manual v Contents 6 . Contrast . .104 7 . Sharpness . .107 8 . Noise . .110 9 . Artifacts . .111 10 . Collimation . .114 11 . Labeling . 115 12 . Conclusion . .116 References . .117 Radiologic Technologist’s Section Introduction . .123 II . Important Points . .129 1 . Time For Quality Control Procedures . .129 2 . Mammography Unit Identification . .132 3 . Cassette Identification . .133 5 . S electing The Appropriate Film, Processing Chemicals, Processor And Processing Time . .134 5 . Film And Chemical Storage . .135 6 . Selecting The Appropriate Thermometer . .136 7 . Selecting The Appropriate Sensitometer . .137 8 .P rocessing And Reading Of Sensitometric Control Strips . .138 9 . Control Charts . .139 10 .Establishing Operating Levels And Control Limits . .140 11 . Mammography Qc Checklists . .142 12 . Test Frequencies . .145 13 . Cassette Use . .146 14 . Adequate Optical Densities In Screen-Film Mammography . .147 15 Adequately Short Exposure Times In Mammography . .148 16 . Technique Charts . .149 vi Mammography Quality Control Manual Contents 17 . Film Viewing Conditions . 151 III . Mammography Quality Control Tests . .153 1 . Darkroom Cleanliness . .153 2 . Processor Quality Control . 155 2A . Establishing Processor Qc Operating Levels . .156 2B . Daily Processor Quality Control . 163 2C . Control Film Crossover . .167 3 . Screen Cleanliness . .171 4 . Phantom Images . .173 5 . Darkroom Fog . 194 6 . Screen-Film Contact . 199 7 . Repeat Analysis . .207 8 . Viewboxes And Viewing Conditions . 213 9 . Analysis Of Fixer Retention In Film . .215 10 . Visual Checklist . 217 IV . Monitoring Developer Temperature and Replenishment Rate . .219 1 . Developer Temperature . .220 2 . Replenishment Rate . 221 V . Mobile Mammography . .221 1 . If Processing Is Immediately Accessible . 223 2 . If Processing Is Not Immediately Accessible . .224 VI . Infection Control . 225 References . .229 Medical Physicists Section I . Introduction . 235 II . Mammography Quality Control Tests . 239 1 . Mammographic Unit Assembly Evaluation . .239 2 . Collimation Assessment . .241 3 . Evaluation Of System Resolution . 246 Mammography Quality Control Manual vii Contents 4 . Automatic Exposure Control (Aec) System Performance Assessment . 249 5 . Uniformity Of Screen Speed . .253 6 . Artifact Evaluation . 256 7 . Image Quality Evaluation . 265 8 . kVp Accuracy And Reproducibility . .277 9 . Beam Quality Assessment (Half-Value Layer Measurement) . 279 10 . Breast Entrance Exposure, Aec Reproducibility, Average Glandular Dose, And Radiation Output Rate . 282 11 . Viewbox Luminance And Room Illuminance . 291 III . Assessing the Mammography Site’s Quality Control Program . 301 IV Summary Report Forms . 303 V . Data Recording And Analysis Forms . 309 VI . MQSA Requirements For Mammography Equipment . .323 VII . Slit Camera Evaluation Of Focal Spot Performance . .329 VIII . References . .333 Glossary . 339 viii Mammography Quality Control Manual Preface PREFACE In 1987, Dr. Gerald Dodd, former Chairman of the American College of Radiology (ACR) Breast Task Force, recognized the need for a “cookbook” style manual on mammography quality control. Dr. Dodd asked that we convene a committee of experts on mammography quality control to tackle the job under the auspices of the ACR. In 1990, the hard work of the original ACR Committee on Mammography Quality Assurance, (Dr. Gerald Dodd, Dr. Joel Gray, Ms. Mary Ann Harvey, Mr. Arthur Haus Dr. R. Edward Hendrick, Dr. Russell Holland, Dr. Robert McClelland, Mr. John McCrohan, Mr. Raymond Rossi, and Dr. Daniel Sullivan), resulted in the publication of three separate manuals: one for the radiologic technologist, one for the medical physicist, and one for the radiologist. Through financial support from the ACR and a grant from the American Cancer Society (ACS), these manuals were provided free of charge to each site accredited by, or applying to, the ACR Mammography Accreditation Program. Second and third editions of the ACR Mammography Quality Control Manual were printed and distributed to all ACR-accredited and applicant sites in 1992 and in 1994 (with the addition of Dr. Lawrence Bassett, Dr. Stephen Feig, Ms. Margaret Botsco, R.T. (R)(M), Ms. Priscilla Butler, M.S., Ms. Rita Heinlein, R.T.(R)(M) and Dr. E. Lee Kitts, Jr. to the Committee). A significant addition to the 1992 and 1994 manuals was the Positioning and Compression Guide developed by Dr. Bassett, Dr. Feig, and Ms. Heinlein. The ACR Mammography Quality Control Manual has received widespread acceptance since its introduction in 1990. The ACR Standards for the Performance of Screening Mammography, adopted by the ACR Board of Chancellors in September 1990, explicitly recognized the importance of quality control in mammography, recommending the performance of tests detailed in the ACR manual. Since January 1992, the ACR Mammography Accreditation Program has required accredited sites to perform and maintain records of the quality control tests in the The ACR Mammography Quality Control Manual. The 1992 Mammography Quality Standards Act (MQSA) significantly elevated the impact of the ACR manual. The 1992 and 1994 ACR Mammography Quality Control Manuals were adopted by reference under the Food and Drug Administrations Interim Rules for Mammography Facilities. All mammography programs in the United States had to employ QC measures that were substantially the same as those outlined in the ACR Mammography Quality Control Manual. While the FDA’s Final Rules for Quality Mammography Standards no longer require that the manual be used as the guideline for conducting QC tests, they have maintained most previous quality control requirements and have added several new ones. This 1999 Edition of the ACR Mammography Quality Control Manual has been modified to be consistent with MQSA Final Rule requirements. The revised manual outlines MQSA requirements and provides guidance on conducting and evaluating QC tests in a manner consistent Mammography Quality Control Manual ix Preface with MQSA Final Rules. The manual goes beyond minimum MQSA requirements by recommending tighter performance criteria in some areas to encourage improved image quality, but we have made every effort to delineate the difference between MQSA requirements and further ACR recommendations. Another new addition to this manual is the “Clinical Image Quality” section that has been developed through the efforts of Dr. Steven Feig, Dr. Lawrence Bassett, and Ms. Rita Heinlein. All of the members of the ACR Committee on Quality Assurance have donated generously of their time and expertise to produce the ACR Mammography Quality Control Manual. Others outside the committee have also volunteered their time and expertise in reviewing drafts of the manual and have provided valuable comments and suggestions; they have our heartfelt thanks. They include Mr. Robert Pizzutiello, Dr. Martin Yaffe, Mr. Eric Berns and especially Dr. Libby Brateman for her thorough and timely critique of the 1999 edition. As with the first three editions of the ACR Mammography Quality Control Manual, special thanks go to Ms. Pamela Wilcox-Buchalla, Senior Director of ACR Accreditation Programs, for serving as the managing editor of these manuals, and to Ms. Susan Flesher, Ms. Victoria Lamb, Mr. Keith Stanger and Mr. Paul Wiegmann for typing, editing and publishing these manuals with such careful attention to detail and quality. Special thanks go also to Ms. Marie Zinninger, Associate Executive Director of the ACR, who has enabled and encouraged this project from its inception, along with the Mammography Accreditation Program, mammography standards, and a number of other significant ACR mammography projects. A final.