ACR PRACTICE GUIDELINE FOR THE PERFORMANCE OF SCREENING AND DIAGNOSTIC MAMMOGRAPHY

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BE IT RESOLVED, Sponsored By: RESOLUTION NO. 11 that the American College of Radiology adopt the ACR Practice Guideline for the Performance of Screening and Diagnostic Mammography ACR Council Steering
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BE IT RESOLVED, Sponsored By: RESOLUTION NO. 11 that the American College of Radiology adopt the ACR Practice Guideline for the Performance of Screening and Diagnostic Mammography ACR Council Steering Committee The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radiation oncologists, and clinical medical physicists in the United States. The College is a nonprofit professional society whose primary purposes are to advance the science of radiology, improve radiologic services to the patient, study the socioeconomic aspects of the practice of radiology, and encourage continuing education for radiologists, radiation oncologists, medical physicists, and persons practicing in allied professional fields. The American College of Radiology will periodically define new practice guidelines and technical standards for radiologic practice to help advance the science of radiology and to improve the quality of service to patients throughout the United States. Existing practice guidelines and technical standards will be reviewed for revision or renewal, as appropriate, on their fifth anniversary or sooner, if indicated. Each practice guideline and technical standard, representing a policy statement by the College, has undergone a thorough consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council. The practice guidelines and technical standards recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guideline and technical standard by those entities not providing these services is not authorized. ACR FOR THE PERFORMANCE OF SCREENING AND DIAGNOSTIC MAMMOGRAPHY PREAMBLE These guidelines are an educational tool designed to assist practitioners in providing appropriate radiologic care for patients. They are not inflexible rules or requirements of practice and are not intended, nor should they be used, to establish a legal standard of care. For these reasons and those set forth below, the American College of Radiology cautions against the use of these guidelines in litigation in which the clinical decisions of a practitioner are called into question. The ultimate judgment regarding the propriety of any specific procedure or course of action must be made by the physician or medical physicist in light of all the circumstances presented. Thus, an approach that differs from the guidelines, standing alone, does not necessarily imply that the approach was below the standard of care. To the contrary, a conscientious practitioner may responsibly adopt a course of action different from that set forth in the guidelines when, in the reasonable judgment of the practitioner, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology subsequent to publication of the guidelines. However, a practitioner who employs an approach substantially different from these guidelines is advised to document in the patient record information sufficient to explain the approach taken. The practice of medicine involves not only the science, but also the art of dealing with the prevention, diagnosis, alleviation, and treatment of disease. The variety and complexity of human conditions make it impossible to always reach the most appropriate diagnosis or to predict with certainty a particular response to treatment. Therefore, it should be recognized that adherence to these guidelines will not assure an accurate diagnosis or a successful outcome. All that should be expected is that the practitioner will follow a reasonable course of action based on current knowledge, available resources, and the needs of the patient to deliver effective and safe medical care. The sole purpose of these guidelines is to assist practitioners in achieving this objective I. INTRODUCTION The goal of mammography is the detection, characterization, and evaluation of findings suggestive of breast cancer and other breast diseases. Periodic Annual screening mammography screening of age-appropriate asymptomatic women is currently the only imaging modality that has been proven to has been shown by the preponderance of data to significantly reduce breast cancer mortality [1-6]. Unlike screening mammography, diagnostic mammography is intended to provide specific analytic evaluation of patients with clinical or screen-detected abnormalities A screening mammogram is an X-ray examination of the breast of an asymptomatic woman. performed in order to detect breast cancer before it becomes clinically evident A diagnostic mammogram is an X-ray examination of the breast of a patient who has with signs or symptoms of breast disease, or who has a possible abnormality detected on screening mammography or by other imaging, or who has prior mammography findings requiring imaging follow-up. technique It is essential that all mammography be performed and interpreted with the highest quality possible [7]. Key points to be considered are the criteria for credentialing professionals (radiologists, radiologic technologists, and medical physicists), equipment specifications, monitoring and maintenance schedules, standards for image quality, standardized image evaluation procedures, meticulous record keeping, and periodic review of data for outcomes of the mammography services All mammography in the United States must be performed in concordance with the Mammography Quality Standards Act (MQSA) final rule legislation and regulations as published by the Food and Drug Administration (FDA) [8]. Nothing in this document should be construed to contradict those regulations. In addition, mammography facilities should have policies and procedures in place for imaging patients with disabilities. II. DEFINITIONS A. Screening Mammography Screening mammography is a radiological examination performed to detect unsuspected breast cancer in asymptomatic women. Standard views are obtained, and thus the interpreting physician does not need to be present at the facility to monitor the examination when the patient is imaged. B. Diagnostic Mammography Diagnostic mammography is a radiographic examination performed to evaluate patients who have signs and/or symptoms of breast disease, imaging findings of concern, or prior imaging findings requiring specific follow-up. Diagnostic mammography requires direct supervision III. GOALS The goal of all mammography is the detection and evaluation of breast cancer and other breast diseases. The goal of diagnostic mammography is to obtain information that leads to specific interpretive conclusions and/or further diagnostic and management recommendations or courses of action. The patient s history, symptoms, and signs, the reported findings on physical examination, and results of any prior mammography will focus the diagnostic breast evaluation. A diagnostic mammogram should be performed under the direct supervision of a physician qualified in mammography under MQSA II. INDICATIONS PATIENT SELECTION A. Screening Mammography [9,10] 1. Annually for asymptomatic women age 40 and older who are at average risk for breast cancer. 2. Asymptomatic women under age 40 who are at increased risk for breast cancer. a. Woman with known mutation or genetic syndrome with increased breast cancer risk: yearly starting by age 30, but not before age 25. b. Untested woman with a first-degree relative with known BRCA mutation: yearly starting by age 30, but not before age 25. c. Woman with a 20% or greater lifetime risk for breast cancer based on breast cancer risk models: yearly starting by age 30, but not before age 25, or 10 years earlier than the age at which the youngest first-degree relative was diagnosed, whichever is later. d. Woman with a history of chest (mantle) radiation received between the ages of 10 and 30: yearly starting 8 years after the radiation therapy, but not before age 25. e. Woman with biopsy-proven lobular neoplasia, atypical ductal hyperplasia (ADH), ductal carcinoma in-situ (DCIS), invasive breast cancer, or ovarian cancer: yearly from time of diagnosis, regardless of age. 3. Age at which annual mammography screening should end. a. There is no defined upper age limit at which mammography may not be beneficial. b. Screening with mammography should be considered as long as the patient is in good health and is willing to undergo additional testing, including biopsy, if an abnormality is detected. 4. Self-referred woman a. Women with no health care provider, who decline having a health care provider, or for whom the health care provider declines responsibility. b. Direct access by individuals is permissible without requiring physician referral in advance. However, screening facilities that elect to accept self-referral patients must have procedures for referring them to a qualified health care provider if abnormal clinical or mammographic findings are present. 5. Self-requesting woman [11] a. A self-requesting woman comes for mammography on her own initiative but is able to provide the name of her personal physician or health care provider. b. In cases where the provider declines to accept the mammography report from the mammography facility, the facility should treat the woman as if she were self-referred [8]. 6. Woman with breast augmentation a. Asymptomatic women with breast implants may undergo screening mammography. b. Facilities must have procedures in place to inquire whether patients have breast implants before a mammogram is performed. c. If a facility does not provide implant imaging services, it should refer the patient to other facilities that provide such services. B. Diagnostic Mammography 1. To assess certain clinical findings that may include a palpable abnormality, persistent focal area of pain or tenderness, bloody or clear nipple discharge, or skin changes. 2. A finding detected on screening mammography that requires further imaging evaluation. This could either be a call-back examination following an abnormal screening mammogram, or conversion of a screening mammogram to a diagnostic mammogram when an abnormality is detected at the time of the screening visit. 3. Short-interval follow-up for probably benign radiographic findings as defined by the ACR Breast Imaging Reporting and Data System (BI-RADS ) [12]. 4. Asymptomatic patients previously treated for breast cancer may undergo screening or diagnostic mammography at the discretion of the facility [13]. 5. Determination that a patient scheduled for screening mammography has a clinical problem, as noted above in section II.B.1. The facility should have a process whereby screening mammography can be converted to diagnostic mammography. 1. Indications Screening mammography is indicated for asymptomatic women 40 years of age or older. It is reasonable to institute screening mammography at an earlier age for high risk women. Symptomatic women, and women with a previously detected abnormality for whom short interval follow-up or further evaluation has been recommended, are not candis for screening mammography 2. Frequency Asymptomatic women 40 years of age or older should have an annual screening mammogram. It is unclear at what age, if any, women cease to benefit from screening mammography. Because this age is likely to vary depending on the individual s overall health, the decision as to when to stop routine mammography screening should be made on an individual basis by each woman and her physician 3. Self-referred woman For screening mammography, a self-referred woman is one who refers herself for medical services and who does not have an identified referring physician or other health care provider. To maximize utilization of screening, direct access by individuals is permissible without requiring physician referral in advance However, screening facilities that elect to accept self-referred patients must have procedures for referring them to a qualified health care provider if abnormal clinical or mammographic findings are present 4. Self-requesting woman A self-requesting woman comes for mammography on her own initiative but is able to provide the name of her personal physician or health care provider. In cases where the provider declines to accept the mammography report from the mammography facility, the facility should treat the woman as if she were self-referred 5. Breast implants Asymptomatic women with breast implants may undergo screening mammography. At the discretion of the facility, asymptomatic women with breast implants may receive a diagnostic mammogram Diagnostic mammography may be appropriate for patients 1. With a specific focus of clinical concern including, but not limited to, mass, induration, axillary lymphadenopathy, some types of nipple discharge, skin changes, or persistent focal areas of pain or tenderness 2. With a possible radiographic abnormality detected on screening mammography. 3. Recommended for short-interval follow-up (e.g., less than 1 year) for probably benign radiographic findings as defined by the ACR Breast Imaging Reporting and Data System (BI-RADS ) 4. Whose examination requires direct involvement of the radiologist for special views, physical breast examination, or consultation 5. Who have been treated for breast cancer. At the discretion of the facility, asymptomatic women may undergo screening or diagnostic mammography If a woman arriving for a screening examination indicates she has a clinical problem (with the exception of bilateral breast pain), the facility should have a process by which she is converted into a diagnostic case, or there should be some means to have her mammogram brought to the attention of the reading radiologist to avoid a delay in reporting C. The Augmented Breast Facilities must have procedures in place to inquire whether patients have breast implants prior to the actual mammographic examination. The facility and/or interpreting physician can then determine whether the woman with breast implants will be imaged at that facility. For asymptomatic women, mammography may be performed as a screening or, at the discretion of the facility, a diagnostic examination. However, if the facility does not provide implant imaging services, it should refer the patient to other facilities that provide such services D. Pregnancy For the pregnant or potentially pregnant patient, see the ACR Practice Guideline for Imaging Pregnant or Potentially Pregnant Adolescents and Women with Ionizing Radiation However, the potential radiation risk of mammography to the fetus is minimal. Shielding should be used, as appropriate III. QUALIFICATIONS AND RESPONSIBILITIES OF PERSONNEL Interpreting physicians, medical physicists, and radiological radiologic technologists who work in mammography must meet the requirements in the Mammography Quality Standards Act (MQSA) final rule published by the Federal Drug Administration (FDA) [8]. IV. SPECIFICATIONS OF THE EXAMINATION A. Screening Mammography 1. The screening examination should be limited to technically adequate craniocaudal (CC) and mediolateral oblique (MLO) views of each breast. 2. Additional views may be required to visualize breast tissue more effectively. 3. Evaluation of the augmented breast, whether done as a screening or a diagnostic examination, should include, when possible, standard CC and MLO views as well as implant displaced views in 2 projections [14]. The interpreting physician does not need to be present at the facility to monitor the examination when the patient is imaged. B. Diagnostic Mammography 1. A diagnostic mammogram may include MLO, CC, and/or supplemental views to evaluate an area of clinical or radiographic concern. 2. Supplemental mammographic views might include spot compression, spot compression with magnification, tangential views, or other special views [14-19]. 3. When selecting a view, the proximity of the area of concern to the image receptor should be considered [14]. 4. Diagnostic mammography should be performed under the immediate supervision of the interpreting physician. 1 C. Request for Mammography The written or electronic request for a diagnostic mammography examination should provide sufficient information to demonstrate the medical necessity of the examination and allow for its proper performance and interpretation. Documentation that satisfies medical necessity includes 1) signs and symptoms and/or 2) relevant history (including known diagnoses). Additional information regarding the specific reason(s) for the examination or a provisional diagnosis would be helpful and may at times be needed to allow for the proper performance and interpretation of the examination. The request for a diagnostic examination must be originated by a physician or other appropriately licensed health care provider. The accompanying clinical information should be provided by a physician or other appropriately licensed health care provider familiar with the patient s clinical problem or question and consistent with the state scope of practice requirements. (ACR Resolution 35, adopted in 2006) D. Imaging Labeling 1. All radiographic images should be labeled in accordance with the current ACR Mammography Quality Control Manual [12]. 2. Both hardcopy and softcopy labeling must include the following information in a permanent, legible, and unambiguous manner, placed so as not to obscure anatomic structures [8]: 1 Immediate supervision is defined as the physician being present and immediately available to furnish assistance and direction throughout the performance of the procedure. Immediate supervision may also be accomplished via telemammography as long as the interpreting physician is immediately available. Mammographic Image Identification 1. Facility name and location, including city, state, and zip code. 2. Patient s first and last names. 3. Unique identification number and/or of birth. 4. Examination. 5. Technologist s initials (or identification number). 6. Cassette (screen) number for nondigital screen-film and computed radiography images. 7. Mammographic unit identification, if there is more than one unit in the facility. 8. View and laterality (placed on the image in a position near the axilla). E. Markers Markers may be used to identify areas of clinical concern or for other situations that could impact an appropriate interpretation (e.g., raised skin lesions, palpable findings, postsurgical changes). The facility should adopt a policy requiring consistent use of two different shapes of radiopaque devices for palpable and skin lesions, respectively. In addition, there should be an indication of the type of underlying lesion marked by every radiopaque device (palpable versus skin lesion), either as a permanent annotation on the appropriate mammographic image(s) or as a description in the mammography report [12]. F. Viewing Issues 1. Screen-film images should be viewed in accordance with the ACR Mammography Quality Control Manual [14]. 2. Images acquired from digital mammographic systems should be viewed in accordance with the ACR AAPM SIIM Practice Guideline for Determinants of Image Quality in Digital Mammography [20]. G. Double Reading and Computer-Aided Detection Double reading and computer-aided detection (CAD) may slightly increase the sensitivity of mammographic interpretation, and may be used. However, this increased sensitivity is usually at the expense of decreased specificity with and increased recall and biopsy rates. At this time, they are not considered standards of care H. Image Retention in Accordance with MQSA Regulations For information regarding image retention, see the Mammography Quality Standards Act Final Regulations and Additions to
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