Mammography X-Ray Systems – Adoption by reference of several sections in

Mammography X-Ray Systems – Adoption by reference of several sections in 21 Code of Federal Regulations Part 900 Subpart B §900.12. 21 Code of Federal Regulations §900.12(b), §900.12(c), §900.12(d), §900.12(e)(1), §900.12(e)(2), §900.12(e)(3), §900.12(e)(4), §900.12(e)(5), §900.12(e)(6), §900.12(e)(7), §900.12(e)(8), §900.12(e)(9), §900.12(e)(10), §900.12(e)(11), §900.12(e)(12), §900.12(f)(1), §900.12(f)(2), and §900.12(i) are adopted by reference as they exist on May 11, 2017, with the following exceptions: 1. Medical Records and Mammography Reports. In addition to the requirements of 21 Code of Federal Regulations §900.12(c), a. Language in mammography reports and lay letters provided to patients receiving mammogram services furnished by the entity performing the mammography services directly to patients under the federal Mammography Quality Standards Act, 42 USC Section 263b shall be in compliance with the U.S. Food & Drug Administration’s Mammography Quality Standards Act. b. Entities providing mammogram services shall consult guidelines and standards developed by the American College of Radiology, the American College of Obstetricians and Gynecologists and the American Cancer Society when developing any additional information the entity deems necessary for inclusion in mammography reports and lay letters. Any additional information provided in the report shall be evidence-based, consistent with accepted medical standards, and with the U.S. Food & Drug Administration’s Mammography Quality Standards Act. Entities shall conduct an annual review of any forms provided to ensure compliance with FDA requirements. SOURCE: Miss. Code Ann. §45-14-11 APPENDIX A Determination Of Competence The following are areas in which the agency considers it important that an individual have expertise for the competent operation of x-ray equipment. I. Familiarization With Equipment. a. Identification of controls. b. Function of each control. c. How to use a technique chart. II. Radiation Protection. a. Collimation. b. Filtration. c. Gonad shielding and other patient protection devices if used. d. Restriction of x-ray tube radiation to the image receptor. e. Personnel protection. f. Grids. III. Film Processing. a. Film speed as related to patient exposure. b. Film processing parameters. c. Quality Assurance Program. IV. Emergency Procedures. a. Termination of exposure in event of automatic timing device failure. V. Proper use of Personnel Dosimetry, if Required. VI. Understanding Units of Radiation. APPENDIX B Information To Be Submitted By Persons Proposing To Conduct Healing Arts Screening Persons requesting that the Agency approve a healing arts screening program shall submit the following information and evaluation: I. Name and address of the applicant and, where applicable, the names and addresses of agents within this State. II. Diseases or conditions for which the x-ray examinations are to be used in diagnoses. III. A detailed description of the x-ray examinations proposed in the screening program. IV. Description of the population to be examined in the screening program, i.e., age, sex, physical condition, and other appropriate information. V. An evaluation of any known alternate methods not involving ionizing radiation which could achieve the goals of the screening program and why these methods are not used instead of the x-ray examinations. VI. An evaluation by a qualified expert of the x-ray system(s) to be used in the screening program. The evaluation by the qualified expert shall show that such system(s) do satisfy all requirements of these regulations. The evaluation shall include a measurement of patient exposures for the x-ray examinations to be performed. VII. A description of the diagnostic x-ray quality control program. VIII. A copy of the technique chart for the x-ray examination procedures to be used. IX. The qualifications of each individual who will be operating the x-ray system(s). X. The qualifications of the individual who will be supervising the operators of the x-ray system(s). The extent of supervision and the method of work performance evaluation shall be specified. XI. The name and address of the individual who will interpret the radiograph(s). XII. A description of the procedures to be used in advising the individuals screened and their private practitioners of the healing arts of the results of the screening procedure and any further medical needs indicated. XIII. A description of the procedures for the retention or disposition of the radiographs and other records pertaining to the x-ray examinations. XIV. An indication of the frequency of screening and the duration of the entire screening program. APPENDIX C Exemptions From Shielding For Certain Fluoroscopic Procedures I. Myelograms II. Arthrograms III. Angiograms IV. Percutaneous nephrostomies V. Biliary drainage procedures VI. Percutaneous cholangiograms VII. T-tube cholangiograms VIII. Sinograms or fistulograms IX. Fluoroscopic biopsy procedures APPENDIX D Actual (feff) and Nominal (fnom) Focal Spot Sizes necessary to achieve an Object Plan Spatial Resolution of 12.5 cycles/mm at the Chest Wall SID Magnification feff fnom (cm) (mm) (mm) 1.07 1.2 0.6 1.08 1.1 0.5 1.11 0.85 0.4 -- 1.5 0.23 0.15 -- 2.0 0.15 0.10 Subchapter 7 Medical Use of Byproduct Material Subchapter 7 Medical Use of Byproduct Material