By: McCall H.B. No. 63 73R246 JMM-D A BILL TO BE ENTITLED 1-1 AN ACT 1-2 relating to the regulation of mammography devices and the practice 1-3 of mammography. 1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: 1-5 SECTION 1. Chapter 401, Health and Safety Code, is amended 1-6 by adding Subchapter L to read as follows: 1-7 SUBCHAPTER L. CERTIFICATION OF MAMMOGRAPHY SYSTEMS 1-8 Sec. 401.421. DEFINITIONS. In this subchapter: 1-9 (1) "Certification" means an authorization for the use 1-10 of a mammography system. 1-11 (2) "Mammography" means the use of radiation to 1-12 produce an image of the breast on film, paper, or digital display 1-13 that may be used to detect the presence of pathological conditions 1-14 of the breast. 1-15 (3) "Mammography system" includes the following: 1-16 (A) an x-ray unit used as a source of radiation 1-17 in producing images of breast tissue; 1-18 (B) an imaging system used for the formation of 1-19 a latent image of breast tissue; 1-20 (C) an imaging processing device for changing a 1-21 latent image of breast tissue to a visual image that can be used 1-22 for diagnostic purposes; 1-23 (D) a viewing device used for the visual 1-24 evaluation of an image of breast tissue if the image is produced in 2-1 interpreting visual data captured on an image receptor; 2-2 (E) a medical radiological technologist who 2-3 performs a mammography; and 2-4 (F) a physician who engages in, and who meets 2-5 the requirements adopted by board rule relating to, the reading, 2-6 evaluation, and interpretation of mammograms. 2-7 Sec. 401.422. CERTIFICATION REQUIRED. (a) A person may not 2-8 perform a mammography unless the mammography system used for the 2-9 mammography has been issued a certification under this subchapter. 2-10 (b) A certification under Subsection (a) is required in 2-11 addition to any license, registration, or other requirement under 2-12 this chapter. 2-13 Sec. 401.423. POWERS AND DUTIES OF BOARD. The board shall: 2-14 (1) prescribe application forms for original and 2-15 renewal certifications; 2-16 (2) set application and certification fees in amounts 2-17 that are reasonable and necessary to defray the costs of the 2-18 administration of this subchapter; 2-19 (3) adopt rules for the administration of this 2-20 subchapter; and 2-21 (4) take other action necessary to enforce this 2-22 subchapter. 2-23 Sec. 401.424. MAMMOGRAPHY CERTIFICATION STANDARDS. (a) To 2-24 receive a mammography certification under this subchapter, the 2-25 mammography system must, at a minimum: 2-26 (1) meet criteria at least as stringent as the 2-27 American College of Radiology mammography accreditation program; 3-1 (2) be specifically designed and used for the 3-2 performance of mammography; 3-3 (3) be operated by an individual certified as a 3-4 medical radiological technologist under Chapter 1096, Acts of the 3-5 70th Legislature, Regular Session, 1987 (Article 4512m, Vernon's 3-6 Texas Civil Statutes), who has successfully completed special 3-7 training in mammography; and 3-8 (4) be used in a facility that: 3-9 (A) has a licensed medical physicist specialized 3-10 in radiology under Chapter 235, Acts of the 72nd Legislature, 3-11 Regular Session, 1991 (Article 4512n, Vernon's Texas Civil 3-12 Statutes), who at least annually provides on-site consultation to 3-13 the facility including a complete evaluation of the entire 3-14 mammography system to ensure compliance with this subchapter; 3-15 (B) maintains records of the consultations 3-16 required under Paragraph (A) for not less than seven years after 3-17 the date the consultation was performed; 3-18 (C) establishes a quality control program that 3-19 meets requirements that are at least as stringent as those of the 3-20 American College of Radiology mammography accreditation program; 3-21 and 3-22 (D) maintains and makes available to a patient 3-23 of the facility original mammograms performed at the facility for 3-24 at least five years after the date the mammography was performed. 3-25 (b) To protect the public health, the board by rule may 3-26 adopt more stringent or additional requirements for: 3-27 (1) the certification of mammography systems; and 4-1 (2) the retention of original mammograms. 4-2 (c) To protect the public health, the board by rule shall 4-3 adopt qualifications for a physician who reads, evaluates, and 4-4 interprets a mammogram that are no less stringent than the 4-5 standards of the American College of Radiology. 4-6 (d) The board shall make available to the public copies of 4-7 the criteria of the American College of Radiology mammography 4-8 accreditation program or the modified criteria adopted by board 4-9 rule. 4-10 Sec. 401.425. ALTERNATIVE CERTIFICATION; EXEMPTIONS. (a) 4-11 The department shall issue a certification under this subchapter 4-12 for a mammography system for which the department is provided proof 4-13 of accreditation by the American College of Radiology or another 4-14 recognized organization that has standards no less stringent that 4-15 the standards of the American College of Radiology. 4-16 (b) A mammography system issued a certification under this 4-17 section is exempt from the certification standards established by 4-18 or under Section 401.424 and the inspection requirements 4-19 established by or under Section 401.430. 4-20 Sec. 401.426. APPLICATION FOR CERTIFICATION. (a) A person 4-21 who owns, leases, or uses or the agent of a person who owns, 4-22 leases, or uses a mammography system must file a written 4-23 application for certification under Section 401.424 or Section 4-24 401.425 on a form prescribed by the board. 4-25 (b) The department may require, at any time after an 4-26 application is filed, further information from the applicant and 4-27 conduct inspections necessary to determine whether the application 5-1 for certification should be granted or denied. 5-2 Sec. 401.427. CERTIFICATION RENEWAL. (a) A certification 5-3 is valid for one year and may be renewed annually on payment of the 5-4 required renewal fee. 5-5 (b) The board by rule may adopt a system under which 5-6 certifications under this subchapter expire on various dates during 5-7 the year. 5-8 (c) If a certification holder fails to renew the 5-9 certification by the required date, the certification holder may 5-10 renew the certification on payment of the renewal fee and a late 5-11 fee set by the board. If the certification is not renewed before 5-12 the 181st day after the date on which the certification expired, 5-13 the certification holder must apply for an original certification 5-14 under this subchapter. 5-15 (d) A mammography system may not be used after the 5-16 expiration date of the certification unless the holder of the 5-17 expired certification has made a timely and sufficient application 5-18 for renewal of the certification as provided under Section 18, 5-19 Administrative Procedure and Texas Register Act (Article 6252-13a, 5-20 Vernon's Texas Civil Statutes), and a final determination of the 5-21 application by the board has not been made. 5-22 Sec. 401.428. DENIAL, SUSPENSION, REVOCATION, OR 5-23 REINSTATEMENT OF CERTIFICATION. (a) The department may deny, 5-24 suspend, revoke, or reinstate a certification. 5-25 (b) The board shall adopt rules establishing the grounds for 5-26 denial, suspension, revocation, or reinstatement of a certification 5-27 and establishing procedures for disciplinary actions. 6-1 (c) Proceedings relating to the suspension or revocation of 6-2 a certification issued under this subchapter are subject to the 6-3 Administrative Procedure and Texas Register Act (Article 6252-13a, 6-4 Vernon's Texas Civil Statutes). 6-5 (d) A person whose certification has been revoked may apply 6-6 for a new certification on the expiration of one year after the 6-7 date the certification was revoked. 6-8 Sec. 401.429. CERTIFICATION FOR MULTIPLE MAMMOGRAPHY 6-9 SYSTEMS. (a) An applicant for certification under Section 401.426 6-10 must obtain a separate certification for each mammography system 6-11 that is owned, leased, or used by the applicant. 6-12 (b) Certification of multiple mammography systems by a 6-13 single applicant may be recorded on a single certification 6-14 document. If multiple mammography systems are recorded on a single 6-15 certification document, each specific machine certified, if any, 6-16 must be identified on the certification document by referring to 6-17 the machine's manufacturer, model number, and serial number. 6-18 Sec. 401.430. INSPECTIONS. (a) The department shall 6-19 inspect each mammography system that receives a certification under 6-20 this subchapter not later than the 60th day after the date the 6-21 certification is issued. 6-22 (b) The department shall inspect, at least once annually, 6-23 each mammography system that receives a certification. 6-24 (c) To protect the public health, the department may conduct 6-25 more frequent inspections than required under this section. 6-26 (d) The department shall make reasonable attempts to 6-27 coordinate inspections under this section with other inspections 7-1 required under this chapter for the facility where the mammography 7-2 system is used. 7-3 (e) After each satisfactory inspection, the department shall 7-4 issue a certificate of inspection for each mammography system 7-5 inspected. The certificate of inspection must be posted at a 7-6 conspicuous place on or near the place where the mammography system 7-7 is used. The certificate of inspection shall: 7-8 (1) specifically identify the mammography system 7-9 inspected; 7-10 (2) state the name and address of the facility where 7-11 the mammography system was used at the time of the inspection; and 7-12 (3) state the date of the inspection. 7-13 (f) A notice of a mammography system's failure to satisfy 7-14 department standards shall be posted: 7-15 (1) on the mammography system at a conspicuous place 7-16 if the system is a machine; or 7-17 (2) near the place where the mammography system 7-18 practices if the system is an individual. 7-19 (g) To protect the public health, the board may adopt rules 7-20 concerning the grounds for posting a failure notice and the 7-21 placement and size of the failure notice. 7-22 Sec. 401.431. TRANSITION. (a) A mammography system is not 7-23 required to have a certification under this subchapter until July 7-24 1, 1994. 7-25 (b) Section 401.422 takes effect July 1, 1994. 7-26 (c) The board shall adopt rules under this subchapter not 7-27 later than January 1, 1994. 8-1 (d) This section expires January 1, 1996. 8-2 SECTION 2. The importance of this legislation and the 8-3 crowded condition of the calendars in both houses create an 8-4 emergency and an imperative public necessity that the 8-5 constitutional rule requiring bills to be read on three several 8-6 days in each house be suspended, and this rule is hereby suspended, 8-7 and that this Act take effect and be in force from and after its 8-8 passage, and it is so enacted.