| (viii) copy of mammography accreditation. (B) Copies of all other records required by this section shall be maintained at a specified location. (2) Records required at separate authorized use locations. Copies of the following shall be kept at each separate authorized use location: (A) credentials for interpreting physicians operating at that location in accordance with subsection (r)(1) of this section; (B) credentials for medical radiologic technologists operating at that location in accordance with subsection (r)(2) of this section; (C) credentials for medical physicists operating at that location in accordance with subsection (r)(3) of this section; (D) continuing education and experience records for interpreting physicians, medical radiologic technologists, and medical physicists operating at that location in accordance with subsection (r)(1)(C), (2)(C), and (3)(C) of this section; (E) mandatory training records for interpreting physicians and medical physicists operating at that location in accordance with subsection (r)(1)(E) and (2)(E) of this section, if applicable; (F) current physicist annual survey of the mammography system; (G) current §289.203 of this title, §289.226 of this title, §289.230 of this title, §289.231 of this title, and §289.234 of this title if accredited by the agency accreditation body; (H) copy of certification; (I) quality assurance program in accordance with subsections (u), (v), and (w) of this section; (J) quality control records in accordance with subsection (u)(2) of this section; (K) operating and safety procedures in accordance with subsection (dd)(1) of this section; (L) records of receipts, transfers, and disposal in accordance with subsection (dd)(3) of this section; (M) calibration, maintenance, and modification records in accordance with subsection (dd)(8) of this section; (N) certification of inspection in accordance with subsection (ff)(5) of this section; (O) notification of failure in accordance with subsection (ff)(6), if applicable; (P) records of notification of patients in accordance with subsection (ff)(10) this section; and (Q) copy of mammography accreditation. (3) Time requirements for record keeping. Time requirements for record keeping shall be according to the following chart. Attached Graphic (ff) Inspections. In addition to the requirements of §289.231(kk) of this title, the following applies to inspections of mammography systems. (1) The agency may inspect each mammography system that receives a certification in accordance with this chapter not later than the 60th day after the date the certification is issued. (2) The agency may inspect, at least once annually, each mammography system that receives a certification. (3) To protect the public health, the agency may conduct more frequent inspections than required by this subsection. (4) The agency may make reasonable attempts to coordinate inspections in this section with other inspections required in accordance with this chapter for the facility where the mammography system is used. (5) After each satisfactory inspection, the agency shall issue a certificate of inspection for each mammography system inspected. The certificate of inspection shall be posted at a conspicuous place on or near the place where the mammography system is used. The certificate of inspection may include the following: (A) specific identification of the mammography system inspected; (B) the name and address of the facility where the mammography system was used at the time of the inspection; and (C) the date of the inspection. (6) Any severity level I violation involving a mammography system, found by the agency, in accordance with §289.205 of this title, constitutes grounds for posting notice of failure of the mammography system to satisfy agency requirements. (A) Notification of such failure shall be posted: (i) on the mammography machine at a conspicuous place if the violation is machine-related; or (ii) near the place where the mammography system practices if the violation is personnel-related; and (iii) in a sufficient number of places to permit the patient to observe the notice. (B) The notice of failure shall remain posted until the facility is authorized to remove it by the agency. A facility may post documentation of corrections of the violations submitted to the agency along with the notice of failure until approval to remove the notice of failure is received from the agency. (7) Facilities that receive a severity level I violation shall notify patients on whom the facility performed a mammogram during the period in which the system failed to meet the agency's certification standards. The facility shall: (A) inform the patient that the mammography system failed to satisfy the agency certifying body's standards; (B) recommend that the patient consult with the patient's physician regarding the need for another mammogram; and (C) list the three facilities closest to the original testing facility that have a certified mammography system. (8) In addition to the requirements of paragraph (7) of this subsection, the agency may require a facility to notify a patient of any other failure of the facility's mammography system to meet the agency's certification standards. (9) The patient notification shall include the following: (A) an explanation of the mammography system failure to the patient; and (B) the potential consequences to the mammography patient. (10) The registrant shall make a record of the mammography patients notified in accordance with paragraphs (7) and (8) of this subsection for inspection by the agency. The records shall include the name and address of each mammography patient notified, date of notification, and a copy of the text sent to the individual. The records shall be maintained in accordance with subsection (ee) of this section. (gg) Requirements for interventional breast radiography machines. (1) Prohibitions. (A) The agency may prohibit use of interventional breast radiography machines that pose a significant threat or endanger public health and safety, in accordance with §289.231 and §289.205 of this title. (B) Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed physician. The provision specifically prohibits intentional exposure of an individual for training, demonstration, or other non-healing arts purposes. (2) Exemptions. (A) Machines used exclusively for interventional breast radiography are not required to be accredited by an FDA-approved accreditation body. (B) Loaner machines as described in subsection (n)(6) of this section are exempt for the inspection requirements in subsection (ff) of this section. (C) All interventional breast radiography registrants are exempt from the posting of radiation area requirements of §289.231(x) of this title provided that the operator has continuous surveillance and access control of the radiation area. (3) Requirements for interventional breast radiography machine certification. (A) Each person having an interventional breast radiography machine shall submit an application in accordance with §289.226(e)(1) - (3), (5), and (7) of this title, and shall receive certification from the agency within 30 days of beginning use. (B) An application for certification shall be signed by a licensed physician, the applicant and the RSO. (C) An application for certification may contain information on multiple interventional breast radiography machines. Each machine must be identified by referring to the machine's manufacturer, model name and serial number on the control panel. (D) Each applicant shall submit documentation of evidence that a medical physicist's survey has been performed in accordance with paragraph (13) of this subsection. (4) Issuance of certification. (A) Certification. A certification for interventional breast radiography machines will be issued if the agency determines that an application meets the requirements of the Act and the requirements of this chapter. The certification authorizes the proposed activity in such form and contains such conditions and limitations as the agency deems appropriate or necessary. Cont'd... |
