Requirements for Suppliers of Mammography Services

PURPOSE: This rule establishes requirements for suppliers of mammography services, including responsibility for the quality of mammographic examinations. (1) The supplier shall be responsible for the overall quality of mammography examinations conducted in each facility. The supplier shall have available the services of a physician consultant and a radiation physicist, either on staff or through arrangement. (2) The supplier shall provide satisfactory assurances, as documented in its medical records, that the images or films of the first and subsequent mammography procedures and the related written reports of the physicians’ interpretations for each patient are either placed in the patient’s medical record kept by the supplier or sent to another person— including the patient—for placement in the patient’s medical record as directed by the patient or by the patient’s physician. If the records of the examination are retained by the supplier, they shall be retained for at least sixty (60) months following the date of service. If the supplier should cease to exist before the end of the sixty (60)-month period, the records shall be transferred to the patient or the patient’s primary care provider. (3) With the consent of the patient, reasonable efforts shall be made by the supplier of the current examination to obtain any of the patient’s previous mammography records— including original images and films—copies of written reports prepared by interpreting physicians, and other relevant information pertinent to previous mammographies that might be available from others, for comparison with the current mammography records. Records of previous mammographies obtained and of current mammographies performed by the supplier shall be properly preserved and made available to other qualified mammography suppliers or others who submit a written request authorized by the patient. (4) The supplier shall make a record for each patient of the mammography services it provides. This record shall include: (A) The date the mammography procedure was performed and the date of the interpretation; (B) The name of the patient; (C) The names of the supplier, the interpreting physician and the equipment operator; (D) A description of the procedures performed; (E) The name of the referring physician, if any, or other physician, if any, identified by the patient to receive the interpreting physician’s written report; and (F) The date the physician’s written report was sent to the appropriate physician or patient. (5) The mammography supplier shall have an orientation program for operators of mammography equipment based on a procedures manual that is available to all staff. The manual shall incorporate relevant documents concerning the following: (A) Precautions to protect the operator of the equipment, the patient and individuals in the surrounding area from unnecessary exposure to radiation; (B) Determination of the area that will receive the primary beam-breast positioning; (C) Pertinent information on compression, exposure levels, resolution, contrast, noise, examination identification, artifacts and average glandular dose per view; (D) Proper use and maintenance of the equipment, including a discussion of the image receptors appropriate for use with mammography and the kilovoltage (kV)-target-filter combination to be used with each image receptor; (E) Proper maintenance of records; and (F) Possible technical problems and solutions. (6) The supplier shall have a mechanism in place which provides for the notification/recall of patients if mammographic examination results are equivocal; notification shall be within two (2) working days after interpretation by the interpreting physician. (7) The supplier shall maintain all documentation and records required by this rule for review by the Department of Health. AUTHORITY: sections 192.762 and 192.766, RSMo Supp. 1992.* This rule was previously filed as 19 CSR 20-11.020. 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 30-11.020 July 30, 1998. *Original authority 1992.