Factors Affecting Phantom Scores at Annual Mammography Facility Inspections by the U.S. Food and Drug Administration

The authors performed this study to evaluate the factors affecting phantom image score at the annual inspection of mammography facilities. In 1997, three U.S. Food and Drug Administration (FDA)–trained inspectors performed inspections of all mammography facilities in North Carolina. All federal and state inspection data were collected and evaluated by using linear regression analysis. Factors affecting the American College of Radiology phantom scores were assessed. Phantom score was affected by inspector identity, view box luminance, and optical density. All of these factors had a statistically significant effect on mass score ( P < .05). Inspector identity yielded a statistically significant effect on speck group score, fibril score, and total score. Luminance yielded a statistically significant effect on both speck group score and total score. Phantom scoring should be automated to allow for more consistent interobserver scoring. In addition, radiology facilities can improve the likelihood of receiving a passing phantom score by reducing the ambient light and increasing the view box luminance in the location where the images are evaluated and the phantom is scored routinely. Radiologists should also consider increasing phantom and clinical image optical density to allow for improved phantom testing outcomes.