| (62) Self-referral mammography--The use of x-radiation to test asymptomatic women for the detection of diseases of the breasts when such tests are not specifically and individually ordered by a licensed physician. (63) Serious adverse event--An adverse event that may significantly compromise clinical outcomes, or an adverse event for which a facility fails to take appropriate corrective action in a timely manner. (64) Serious complaint--A report of a serious adverse event. (65) Source-to-image receptor distance (SID)--The distance from the source to the center of the input surface of the image receptor. (66) Standard breast--A 4.2 cm thick compressed breast consisting of 50% glandular and 50% adipose tissue. (67) Survey--An on-site physics consultation and evaluation of a facility quality assurance program performed by a medical physicist. (68) Technique chart--A chart that provides all necessary generator control settings and geometry needed to make clinical radiographs. (69) Traceable to a national standard--Calibrated at either the National Institute of Standards and Technology (NIST) or at a calibration laboratory that participates in a proficiency program with NIST at least once every two years. The results of the proficiency test conducted within 24 months of calibration shall show agreement within plus or minus 3.0% of the national standard in the mammography energy range. (d) Prohibitions. (1) Radiographic equipment designed for general purpose or special nonmammography procedures shall not be used for mammography. This includes systems that have been modified or equipped with special attachments for mammography. (2) The agency may prohibit use of mammography machines that pose a significant threat or endanger public health and safety, in accordance with §289.231 of this title and §289.205 of this title. (3) 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. This provision specifically prohibits intentional exposure for the following purposes: (A) exposure of an individual for training, demonstration, or other non-healing arts purposes; (B) exposure of an individual for the purpose of healing arts screening (self referral mammography) except as authorized by subsection (bb) of this section; and (C) exposure of an individual for the purpose of research except as authorized by subsection (cc) of this section. (e) Exemptions. (1) Mammography machines or cabinet x-ray machines used exclusively for examination of breast biopsy specimens are exempt from the requirements of this section. These machines are required to meet applicable provisions of §289.226 of this title and §289.228 of this title (relating to Radiation Safety Requirements for Analytical and Other Industrial Radiation Machines). (2) Mammography machines used exclusively for interventional breast radiography are exempt from the requirements of this section except for those listed in subsection (gg) of this section. These machines are not required to be accredited by an FDA-approved accreditation body. (3) Loaner machines as described in subsection (n)(5) of this section are exempt from the inspection requirements in subsection (ff) of this section. These machines are not required to be accredited by an FDA-approved accreditation body. (4) Mammography machines with investigational device exemptions as described in subsection (cc) of this section and used in clinical studies are exempt from the requirements of this chapter. These machines are not required to be accredited by an FDA-approved accreditation body. (5) All mammography 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. (f) Requirements for mammography systems certification. (1) To obtain a certification, facilities shall meet the quality standards in subsections (r) - (aa) of this section and be accredited by an FDA-approved accreditation body. In order to qualify for certification, new facilities must apply to the agency certifying body in accordance with the following requirements and to an FDA-approved accreditation body and receive acceptance of the accreditation application. If the facility chooses to be accredited by the agency accreditation body, the facility shall submit the information required in this subsection and §289.234(d) of this title. (2) Each person having a mammography machine shall submit an application in accordance with §289.226(e)(1) - (3) and (5) - (7) and (f)(4) - (5) of this title, and receive certification from the agency certifying body before beginning use of the mammography machine on humans. (3) An application for certification shall be signed by the lead interpreting physician. The signature of the applicant and the radiation safety officer (RSO) shall also be required. (4) An application for certification may contain information on multiple mammography machines. Each mammography machine must be identified by referring to the machine's manufacturer, model name, and serial number on the control panel. If this is not a new certification, the registrant shall maintain and provide proof of current accreditation. If accreditation expires before the expiration of the certification, the registrant shall submit proof of renewed status to the agency. (5) Each applicant shall submit documentation of the following: (A) personnel qualifications, including dates of licensure or certification, in accordance with subsection (r) of this section; (B) manufacturer, model name, and serial number of each mammography machine control panel; (C) evidence that a medical physicist: (i) has determined that each machine meets the equipment standards in subsection (s) of this section; (ii) has performed a survey and a mammography equipment evaluation in accordance with subsection (v)(10) and (11) of this section; and (iii) has determined that the average glandular dose for one craniocaudal-caudal view for each machine does not exceed the value in subsection (v)(5)(F) of this section; (D) self-referral program information in accordance with subsection (bb) of this section, if the facility offers self-referral mammography; and (E) items required for authorization of a mobile service operation in accordance with §289.226(g) of this title, if the facility provides a mobile service. (g) Issuance of certification and provisional certification. (1) Certification. A certification will be issued if the agency certifying body 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 certifying body deems appropriate or necessary. The certification may include one of the following: (A) mammography systems and facilities certification, following approval of accreditation by an FDA-approved accreditation body; or (B) certification of interventional breast radiography machines. (2) Requirements and conditions. The agency certifying body 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: (A) minimize danger to occupational and public health and safety; (B) require additional reports and the keeping of additional records as may be appropriate or necessary; and (C) prevent loss or theft of radiation machines subject to this section. (3) Additional information. The agency certifying body may request, and the registrant shall provide, additional information after the certification has been issued to enable the agency certifying body to determine whether the certification should be modified in accordance with §289.226(r) of this title. (4) Provisional certification application. A new facility is eligible to apply for a provisional certification. The provisional certification will enable the facility to perform mammography and to obtain the clinical images needed to complete the accreditation process. To apply for and receive a provisional certification, a facility must meet the requirements of this chapter and submit the necessary information to an FDA-approved accreditation body. If the facility chooses to be accredited by the agency accreditation body, the facility shall submit the information required in subsection (f) of this section and §289.234(d) of this title to the agency accreditation body. Cont'd... |
