Maintenance of Mammography Records

PURPOSE: This rule establishes requirements for maintenance of quality assurance records by the supplier. (1) Records of all quality assurance tests for mammography X-ray equipment shall include the following: (A) The initial mammographic equipment performance evaluation and subsequent evaluations and testing; (B) Verification that the mammographic Xray equipment is in safe operating order; and (C) Quality assurance test results. (2) Records or written logs of maintenance and any repairs of mammographic X-ray equipment shall be kept for at least three (3) years. (3) Film processor control charts used to regulate proper processor function shall be kept for at least two (2) years. (4) Film processor maintenance logs shall include all of the following records and these records shall be kept for at least two (2) years: preventive maintenance; corrective maintenance; and cleaning and replacement of chemicals. (5) Each film processor record entry shall be dated and signed or initialed by the individual who performed the quality assurance test. (6) Records of calibration, monitoring results, the radiation physicist’s on-site consultation and the physician consultant’s annual review shall be documented in the supplier’s records and shall be readily available for review by agents of the Department of Health. AUTHORITY: sections 192.762 and 192.766, RSMo Supp. 1992.* This rule was previously filed as 19 CSR 20-11.090. Emergency rule filed Oct. 5, 1992, effective Oct. 15, 1992, expired Feb. 12, 1993. Emergency rule filed Feb. 3, 1993, effective Feb. 13, 1993, expired June 12, 1993. Original rule filed Nov. 4, 1992, effective June 7, 1993. Changed to 19 CSR 30-11.090 July 30, 1998. *Original authority 1992.