The American College of Radiology Mammography Accreditation Program

This article discusses the background, goals, criteria, current results, impact, and future directions of the American College of Radiology's (ACR's) Mammography Accreditation Program. To date, approximately one half of the mammographic units in the United States have voluntarily applied for accreditation through the ACR program, with approximately one quarter of the units in the United States now accredited. Application rates have increased steadily since the start of the program in August 1987. The equipment performance criteria and professional criteria defined and employed in the ACR Mammography Accreditation Program have been adopted as standards for the performance of screening mammography by the ACR and have served as a basis for quality assurance standards in state and federal legislation on mammography.     

The politics of mammography.

Mammography has had a major impact on the earlier detection, treatment options, and management decisions and survival and mortality rates of breast cancer. Consequences include overwhelming demand for mammography; problems with optimum response by radiology; limited availability of the examination, especially to the socioeconomically disadvantaged; self-referral for mammography by unqualified physicians for less than altruistic reasons; and unrealistic expectations of mammography by women, physicians, and lawyers. Responses to the overwhelming demand for high-quality mammography include ACR postgraduate and continuing education courses and its mammography accreditation program; a more comprehensive examination on mammography for certification by the ABR; and increasing state and federal government interest and legislation for reimbursement, quality assurance, and delivery of mammography. The precedents this sets for radiology if not all of medicine suggests that collaboration of the private and public sectors offers the greatest promise of an appropriate response, namely reproducible optimum mammography accurately interpreted with the lowest possible radiation dose for all eligible women in the United States.     

Mammography processor quality assurance

After completing this article on mammographic processing, readers will: Understand the relationship between mammography and breast cancer survival. Define quality assurance and quality control. Discuss the history of the Mammography Quality Standards Act. List the important considerations in processor setup. Name the tests in the medical physicist survey. Know how to perform daily processor quality control. Understand the importance of continuous quality improvement.     

MQSA (Mammography Quality Standards Act) update--focusing on quality assurance

To have uniform national standards, Congress passed the Mammography Quality Standards Act (MQSA) in 1992. Screening and diagnostic facilities must now meet minimum quality standards for personnel, equipment and recordkeeping, and be certified by the FDA, the federal agency designated to implement MQSA. The FDA is responsible for developing final standards, approving accrediting bodies, certifying all mammography facilities in the U.S., evaluating the effectiveness of the program, and implementing sanctions for noncompliant facilities. Congress recognized the urgent need for national mammography standards, but realized that 10,000 mammography facilities could not be certified to meet the regulations before October 1, 1994. President Clinton signed legislation granting the FDA Interim Rule authority and allowing the FDA to adopt existing standards from the ACR, HCFA and state regulations. The Final Rules have significant changes in the Quality Assurance (QA) Sections (900.12 d and e) and indicate where staff must now conduct, document and evaluate the results of QA tests, taking responsibility for establishing and maintaining a QA program that ensures safety, reliability, clarity and accuracy of the mammography services they perform. The Rules also specify the roles of interpreting physicians, medical physicists and quality control technologists. Data indicates that such regulation has improved mammography in the U.S. By January 1997, the Government Accounting Office reported that 1,500 facilities had undergone two rounds of MQSA inspections. During the first year of MQSA, 26 percent had significant violations, while only 10 percent did on the second round.     

Mammography in the 1990s: the United States and Canada

PURPOSE: To evaluate trends in mammography quality before and after the implementation of the Mammography Quality Standards Act (MQSA) of 1992 and to compare technical data collected in the United States with corresponding data obtained from the first survey of mammography facilities conducted in 1994-1995 in Canada. MATERIALS AND METHODS: Data from MQSA inspections conducted in 1995-1997 were analyzed and compared with survey data on U.S. mammography facilities acquired before the MQSA. Technical indicators of mammography quality such as radiation dose phantom image score, film processing, and darkroom fog were analyzed. RESULTS: In the United States, phantom image scores, along with other technical measures of performance such as film processing, darkroom fog, and x-ray beam quality, have improved continuously since 1985. The U.S. mean glandular dose has increased to 1.6 mGy compared with the Canadian dose of 1.1 mGy. The mean total phantom image score with artifact subtraction was 11.1 in Canada in 1994-1995 and 11.8 in the U.S. in 1997. CONCLUSION: Mammography quality is better today than it has been at any other time in the United States. With the exception of radiation dose. Canadian technical measures of performance are comparable to measures before MQSA in the United States.     

Quality assurance activities in healthcare facilities

Since the 1960s there have been concerted efforts to initiate, develop, and promulgate quality assurance policies and protocols in healthcare facilities in the United States. These activities were spurred mainly by the Joint Commission on Accreditation of Healthcare Organizations, which ensures that hospitals monitor and evaluate their services based on predetermined criteria. This paper considers how quality assurance activities have been implemented in healthcare facilities, reviews various obstacles to the full development of the quality assurance program, and suggests several areas in which corrective actions could be undertaken.     

The final rule: what administrators must know by April 28.

On April 28, 1999, the Final Rule of the Mammography Quality Standards Act (MQSA) goes into effect. The Final Rule remains basically the same, with the addition of a few new specifications and modifications. The Quality Standards are divided into two parts. To obtain and maintain compliance with the standards, facilities must be most familiar with sections 900.10 through 900.12 in Subpart B. A policy on reinstatement, added to the section on requirements for certification, outlines the conditions facilities must meet to have their certification reinstated. The requirements for mammography personnel, equipment and general quality assurance standards are listed in section 900.12, (a) through (j). A new requirement is that mammography technologists must have 40 hours of direct instruction, eight of which must include training in each modality they will use to perform examinations. All mammography personnel must have a minimum of eight hours training before working independently in a new modality. The Final Rule makes it clear that mammography facilities are responsible for communicating test results to patients. Under the Final Rule, responsibility for a facility's quality assurance program now belongs to the lead-interpreting physician, a position facilities are now required to have. Facility cleanliness and infection control standards have been added to the section on QA requirements. The Final Rule establishes that facilities must establish and implement an infection control program, as well as a documented procedure for resolving consumer complaints.     

1998 MQSA (Mammography Quality Standards Act) final rule released. American College of Radiology

In October 1997, the Food and Drug Administration (FDA) released the final regulations for implementing the Mammography Quality Standards Act (MQSA). Briefly, the final rule establishes experience requirements for medical physicists and radiologic technologists and clarifies equipment standards. The Interim Rules, issued in late 1993 and amended in 1994, now apply. Final regulations become effective April 1999, with certain equipment regulations becoming effective in October 2002. Changes in experience and continuing education requirements for medical physicists and radiologic technologists parallel requirements in the interim rule. The FDA shifted the majority of quality assurance requirements for equipment to the quality assurance section of the regulations, and will treat them as performance standards. Under the final rule, each facility is required to have a system to ensure that mammogram exam results are communicated to patients in a timely manner. Under the interim regulations, mammography facility personnel must continue to participate in medical education programs in mammography to acquire five CME/CEU per year.     

Auditing and benchmarks in screening and diagnostic mammography

Radiologists can use outcome data such as cancer size and stage to determine how well their own practice provides benefit to their patients and can use measures such as screening recall rates and positive predictive values to assess how well adverse consequences are being contained. New data on national benchmarks for screening and diagnostic mammography in the United States allow radiologists to evaluate their own performance with respect to their peers. This article discusses recommended outcome values in the United States and Europe, current Mammography Quality Standards Act audit requirements, and Institute of Medicine proposals for future requirements.     

Quality assurance in radiology from the viewpoint of the specialists and the supervisory authorities]

Quality assurance for diagnostic imaging equipment has been successful so far. In the old Federal Republic of Germany, inspection of the existing equipment in diagnostic radiology in being completed. The estimated number of uninspected units is relatively small. All detected shortcomings have been repaired in the meantime, and very few faults have been detected in newly installed equipment. Of the status obtained following inspection and repair is to be maintained, however, more effective methods must be implemented. There is no doubt that everybody involved in quality assurance programs, including the experts and supervisory authorities, is actively working on improving the results.     

Has the mammography quality standards act affected the mammography quality in North Carolina?

OBJECTIVE: The United States Food and Drug Administration implemented federal regulations governing mammography under the Mammography Quality Standards Act (MQSA) of 1992. During 1995, its first year in implementation, we examined the impact of the MQSA on the quality of mammography in North Carolina. MATERIALS AND METHODS: All mammography facilities were inspected during 1993-1994, and again in 1995. Both inspections evaluated mean glandular radiation dose, phantom image evaluation, darkroom fog, and developer temperature. Two mammography health specialists employed by the North Carolina Division of Radiation Protection performed all inspections and collected and codified data. RESULTS: The percentage of facilities that met quality standards increased from the first inspection to the second inspection. Phantom scores passing rate was 31.6% versus 78.2%; darkroom fog passing rate was 74.3% versus 88.5%; and temperature difference passing rate was 62.4% versus 86.9%. CONCLUSION: In 1995, the first year that the MQSA was in effect, there was a significant improvement in the quality of mammography in North Carolina. This improvement probably resulted from facilities' compliance with federal regulations.     

Konzept und Durchführung der Modellprojekte für Mammographiescreening in Deutschland

The carriers of the German Statutory Health Care System have recognized that only mammographic screening according to the European Guidelines for the Quality Assurance of Mammography Screening will permit early detection of breast cancer with an acceptable risk/benefit ratio. In the German pilot projects, regional mammography screening programmes according to the European guidelines are being tested in the framework of the German health care system. The European guidelines require comprehensive quality assurance of all relevant steps in the chain of events involved in screening, from invitation on to therapy and follow-up. Such comprehensive quality assurance involves several medical specialities and other professional groups dealing with out-patient and in-patient health care and requires long-term cooperation with public institutions (population registries, cancer registries). The objective of the pilot projects is to test the organizational and legal conditions essential to introduction of a mammographic screening programme according to the European quality assurance guidelines in Germany.     

Mammography screening: successes and problems in implementing widespread use in the United States

Deterrents to the use of screening mammography include perceived risks of radiation, perceived "unnecessary" biopsies and overdiagnosis, and high cost. In addition, physicians and patients have attitudinal barriers that do not reflect objective realities. Professional and public education efforts are needed to enable women and their physicians to develop a more sophisticated understanding of the usefulness of screening mammography and the role played by the radiologist. As part of their efforts to increase the implementation of screening mammography, the American College of Radiology has developed a Mammography Accreditation Program for radiological facilities and has produced a free Mammography Resource Kit for radiologists, while the American Cancer Society has undertaken the support of local and national campaigns to establish screening programs at reduced cost. Both organizations continue to strive in partnership to increase the acceptance of screening throughout the United States.     

Quality assurance in mammography: artifact analysis.

Evaluation of mammograms for artifacts is essential for mammographic quality assurance. A variety of mammographic artifacts (i.e., variations in mammographic density not caused by true attenuation differences) can occur and can create pseudolesions or mask true abnormalities. Many artifacts are readily identified, whereas others present a true diagnostic challenge. Factors that create artifacts may be related to the processor (eg, static, dirt or excessive developer buildup on the rollers, excessive roller pressure, damp film, scrapes and scratches, incomplete fixing, power failure, contaminated developer), the technologist (eg, improper film handling and loading, improper use of the mammography unit and related equipment, positioning and darkroom errors), the mammography unit (eg, failure of the collimation mirror to rotate, grid inhomogeneity, failure of the reciprocating grid to move, material in the tube housing, compression failure, improper alignment of the compression paddle with the Bucky tray, defective compression paddle), or the patient (e.g., motion, superimposed objects or substances [jewelry, body parts, clothing, hair, implanted medical devices, foreign bodies, substances on the skin]). Familiarity with the broad range of artifacts and the measures required to eliminate them is vital. Careful attention to darkroom cleanliness, care in film handling, regularly scheduled processor maintenance and chemical replenishment, daily quality assurance activities, and careful attention to detail during patient positioning and mammography can reduce or eliminate most mammographic artifacts.     

A program for quality assurance of computerized treatment planning systems.

Quality Assurance (QA) on computerized treatment planning systems is currently an area that requires considerable attention. To meet this objective a simple yet effective quality assurance program has been developed and implemented at the Cross Cancer Institute.     

Quality assurance. How to audit your own mammography practice.

The medical audit is an important component of a comprehensive mammography quality assurance program. It provides a direct assessment of one's ability to detect otherwise occult breast cancer, the ultimate indicator of mammography performance. Audits must be properly planned, executed, interpreted, and used. The audit that shows successful clinical results can be used to build and maintain a high state of morale among mammography personnel as well as to encourage new and repeat referrals to a mammography practice. The audit that uncovers a deficiency in clinical performance can be instrumental in helping to plan remedial measures that correct the problem.     

Mammography in the eighties

Mammography has experienced the greatest change of any existing radiologic examination in recent years. In 1985, as a part of the Nationwide Evaluation of X-Ray Trends (NEXT) program, a national survey was conducted of a statistically selected sample (n = 232) of facilities performing mammography examinations in the United States. By 1988, the number of mammography facilities in the United States had increased to over 6,400, an increase of over 60% from the 1985 level. To assess the consequence of this expansion as well as the impact of recent technological and other significant developments on mammography, a NEXT survey of mammography facilities was repeated in 1988 (n = 226). Screen-film mammography accounted for 83% of the facilities surveyed in 1988, and dedicated equipment dominated screen-film systems (99%). There was a 26% increase in the overall mean phantom image score, over 45% increase in the use of grids, and 10% increase in mean glandular dose for systems using grids.     

Current Guidelines and Gaps in Breast Cancer Screening

Breast cancer is the most common nonskin cancer in women and the second leading cause of cancer death for women in the United States. Mammography screening is proven to significantly decrease breast cancer mortality, with a 40% or more reduction expected with annual use starting at age 40 for women of average risk. However, less than half of all eligible women have a mammogram annually. The elimination of cost sharing for screening made possible by the Affordable Care Act (2010) encouraged screening but mainly for those already insured. The United States Preventive Services Task Force 2009 guidelines recommended against screening those 40 to 49 years old and have left women over 74 years of age vulnerable to coverage loss. Other populations for whom significant gaps in risk information or screening use exist, including women of lower socioeconomic status, black women, men at higher than average risk of breast cancer, and sexual and gender minorities. Further work is needed to achieve higher rates of screening acceptance for all appropriate individuals so that the full mortality and treatment benefits of mammography screening can be realized.     

ACR Appropriateness Criteria Evaluation of the Symptomatic Male Breast

Most male breast problems are benign, and men with typical symptoms of gynecomastia or pseudogynecomastia do not usually need imaging. When a differentiation between benign disease and breast cancer cannot be made on the basis of clinical findings or when the clinical findings are suspicious for breast cancer, imaging is indicated. Mammography is useful in both identifying cancer and obviating the need for biopsy in patients for whom a benign mammographic impression confirms the clinical impression. However, because of the relationship of breast cancer to increasing age, age-based protocols that do not include mammography have been developed. For men with an indeterminate palpable mass, begin with ultrasound if the patient is <25 years of age, because breast cancer is highly unlikely. Mammography should be performed if ultrasound is suspicious. For men ≥25 years of age or having a highly concerning physical examination, usually begin with mammography; ultrasound is useful if mammography is inconclusive or suspicious.The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals, and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.