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January 10, 2006 5E6155 A-1
Appendix A: Quality Control
Procedures
Compliance Guide - Quality Control for Laser Imagers Used in
Digital Mammography Systems
These Quality Control Procedures are intended to provide guidance for
mammography facilities and their personnel. They represent the equipment
manufacturer’s views on the appropriate procedures for conducting Quality
Control tests for digital mammography and observing the Mammography
Quality Standards Act (MQSA). The following procedures represent
acceptable ways of doing the tests, but unlike regulations, they are not
binding. Alternate procedures may be used if they satisfy the requirements
of the applicable statute, regulations or both. It is the responsibility of the
mammography facility to read, understand and follow the regulations.
Under its own authority, a state may impose requirements more stringent
than those imposed in the FDA Mammography Quality Standards Act. A
facility should check with state or local authorities regarding their
requirements.
Automatic Image Quality
Control and the QC
Process
The Kodak DryView 8900 Laser Imager has a built-in Automatic Image
Quality Control (AIQC) system that automatically compensates for film lot
variations, ensuring consistent print densities. The MQSA requires that the
mammography facility establish a quality control (QC) process that verifies
the effectiveness of the AIQC system. Kodak's recommendations below are
based on the MQSA and the QC process described in the Radiologic
Technologist's Section of the Mammography Quality Control Manual, 1999,
published by the American College of Radiology. This QC process has been
adapted to apply to the special features of Kodak DryView Mammography
Laser Imaging Film and the characteristics of the 8900 Laser Imager. The
procedures that follow assume that the user has been trained in operation
of the 8900 Laser Imager.