| (B) Requirements and conditions. The agency may incorporate in the certification at the time of issuance, or thereafter by amendment, such additional requirements and conditions with respect to the registrant's possession, use, and transfer of radiation machines subject to this chapter as it deems appropriate or necessary in order to: (i) minimize danger to occupational and public health and safety; (ii) require additional reports and the keeping of additional records as may be appropriate or necessary; and (iii) prevent loss or theft of radiation machines subject to this section. (C) Additional information. The agency may request, and the registrant shall provide, additional information after the certification has been issued to enable the agency to determine whether the certification should be modified in accordance with §289.226(r) of this title. (5) Modification, suspension, or revocation of certification. Modification, suspension, or revocation of certification shall be in accordance with §289.226(r) of this title. (6) Specific terms and conditions of certification. Specific terms and conditions of certification shall be in accordance with §289.226(l) of this title. (7) Responsibilities of registrant. (A) The registrant shall comply with the following: (i) purpose and scope in accordance with subsections (a) and (b) of this section; and (ii) applicable definitions in subsection (c) of this section. (B) In addition to the requirements of §289.226(m)(3) - (7) of this title, a registrant shall notify the agency in writing prior to any changes that would render the information contained in the application or the certification inaccurate. These include but are not limited to the following: (i) name and mailing address; (ii) street address where interventional breast radiography machine(s) will be used; and (iii) interventional breast radiography machine(s). (C) If a facility makes a change in the RSO, the qualifications of the RSO shall be submitted to the agency within 30 days of such change. (D) A facility with an existing certification may begin using a new or replacement interventional breast radiography machine before receiving an updated certification if the registrant submits to the agency (required/prescribed) documentation with a medical physicist's report in accordance with paragraph (13) of this subsection, verifying compliance of the new interventional breast radiography machine with this section. The medical physicist's report is required prior to using the interventional breast radiography machine on patients. (E) Loaner interventional breast radiography machines may be used on patients for 60 days without adding the interventional breast radiography machine to the certification. A medical physicist's report verifying compliance of the loaner interventional breast radiography machine with this section shall be completed prior to use on patients. If the use period will exceed 60 days, the facility shall add the interventional breast radiography machine to its certification and a fee will be assessed. (8) Renewal of certification. The registrant shall file an application for renewal of certification as follows. (A) Each person having an interventional breast radiography machine shall submit an application for renewal in accordance with §289.226(e)(1) - (3), (5), and (7) of this title. (B) An application for renewal shall be signed by the RSO, licensed physician, and the applicant. (C) An applicant for renewal shall submit a medical physicist's survey in accordance with paragraph (13) of this subsection. (D) If a registrant files an application for renewal in proper form at least 30 days before the existing certification expires, such existing certification shall not expire until the application status has been determined by the agency. (9) Expiration of certification. (A) Each certification of interventional breast radiography machine expires at the end of the day in the month and year stated on the certificate. Expiration of the certification does not relieve the registrant of the requirements of this chapter. (B) If a registrant does not submit an application for renewal of the certification under paragraph (8) of this subsection, as applicable, the registrant shall on or before the expiration date specified in the certification: (i) terminate use of all interventional breast radiography machines; (ii) pay any outstanding fees in accordance with §289.204 of this title; and (iii) submit a record of the disposition of the interventional breast radiography machine(s) to the agency. If the machine(s) was transferred, include to whom it was transferred. (10) Termination of certification. When a registrant decides to terminate all activities involving interventional breast radiography machine(s) authorized under the certification, the registrant shall notify the agency immediately and do the following: (A) request termination of the certification in writing signed by the RSO, owner, or an individual authorized to act on behalf of the registrant; (B) pay any outstanding fees in accordance with §289.204 of this title; and (C) submit a record of the disposition of the interventional breast radiography machine(s) to the agency certifying body. If the machine(s) was transferred, include to whom it was transferred. (11) Personnel requirements. (A) A medical radiologic technologist (operators of equipment) shall hold a current general certificate in accordance with the Medical Radiologic Technologist Certification Act, Texas Occupations Code, Chapter 601. (B) A medical physicist shall hold a current Texas license under the Medical Physics Practice Act, Texas Occupations Code, Chapter 602, in diagnostic radiological physics and be registered with the agency or employed by an entity registered with the agency, in accordance with §289.226(j) of this title and the Act, unless exempted by §289.226(d)(6) of this title. (12) Requirements to have a written quality assurance program. Requirements to have a written quality assurance program as described by the manufacturer and/or the medical physicist to ensure the safety, reliability, clarity, and accuracy of services performed at the facility shall comply with the following. (A) If any failures are noted, corrective actions shall be taken within the time frame indicated/established by the manufacturer or medical physicist. In the event, that no time frames are indicated, corrective action shall be completed within 30 days of the failure. (B) If any component tested fails the dosimetry test, the corrective action will be taken before any further interventional breast radiography examinations are performed. (13) Interventional breast radiography machine evaluations and annual survey. (A) Interventional breast radiography machines are required to have a medical physicist perform a survey: (i) whenever a new interventional breast radiography machine is installed, disassembled, and reassembled at the same or a new location; (ii) whenever major components of an interventional breast radiography machine are changed or repaired; and (iii) on an annual basis. (B) The following quality assurance tests shall be performed: AEC, kVp, focal spot condition, HVL, collimation, alignments, and dosimetry tests in accordance with subsection (v)(5)(A) - (G) of this section. (C) The medical physicist shall provide the facility with a preliminary oral or written report of deficiencies within 72 hours of the survey if it involves dosimetry. (D) The medical physicist shall prepare a written report for the facility within 30 days of the date of the survey to include the following: (i) a written survey report that includes a summary of the tests performed, all test conditions, specifications, results, and recommendations for corrective actions; and (ii) date and signature of the medical physicist performing or supervising the survey. If the survey was performed entirely or in part by another individual under the direct supervision of the medical physicist, that individual and the part of the survey that individual performed shall also be identified in the survey. (14) Operating and safety procedures. Each registrant shall have and implement written operating and safety procedures that shall be made available to each individual operating x-ray equipment, including any restrictions of the operating technique required for the safe operation of the particular system. These procedures shall include, but are not limited to: (A) posting notices to workers in accordance with §289.203(b) of this title; Cont'd... |
