Quality Assurance Requirements

Section 370 Section 370.100  Quality Assurance Requirements Each facility shall establish and maintain a quality assurance program to ensure the safety, reliability, clarity and accuracy of mammography services performed at the facility. a)         Responsible individuals.  Responsibility for the quality assurance program and for each of its elements shall be assigned to individuals who are qualified for their assignments and who shall be allowed adequate time to perform these duties. 1)         Lead interpreting physician.  The facility shall identify a lead interpreting physician who shall have the general responsibility of ensuring that the quality assurance program meets all requirements of this Section and Sections 370.110, 370.120(b) and (c) and 370.130 of this Part.  No other individual shall be assigned or shall retain responsibility for quality assurance tasks unless the lead interpreting physician has determined that the individual's qualifications for, and performance of, the assignment are adequate. 2)         Interpreting physicians.  All interpreting physicians interpreting mammograms for the facility shall: A)        Follow the facility procedures for corrective action when the images they are asked to interpret are of poor quality; and B)        Participate in the facility's medical outcomes audit program. 3)         Medical physicist.  Each facility shall have the services of a medical physicist available to survey mammography equipment and oversee the equipment-related quality assurance practices of the facility.  At a minimum, the medical physicist shall be responsible for performing the surveys and mammography equipment evaluations and providing the facility with the reports described in Section 370.110(i) of this Part. 4)         Quality control technologist.  Responsibility for all individual tasks within the quality assurance program not assigned to the lead interpreting physician or the medical physicist shall be assigned to a quality control technologist.  The tasks are to be performed by the quality control technologist or by other personnel qualified to perform the tasks.  When other personnel are utilized for these tasks, the quality control technologist shall ensure that the tasks are completed in such a way as to meet the requirements of Section 370.110 of this Part. b)         Personnel quality assurance records.  The lead interpreting physician, quality control technologist and medical physicist shall ensure that records concerning employee qualifications to meet assigned quality assurance tasks, mammography technique and procedures, quality control (including monitoring data, problems detected by analysis of that data, corrective actions and the effectiveness of the corrective actions), safety, and protection are properly maintained and updated.  These quality control records shall be kept for each test specified in Section 370.110 of this Part until the next annual inspection has been completed and the Agency has determined that the facility is in compliance with the quality assurance requirements or until the test has been performed two additional times at the required frequency, whichever is longer.