H.B. No. 63 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 mammography unless the mammography system used has been 2-9 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. (a) The board 2-14 shall: 2-15 (1) prescribe application forms for original and 2-16 renewal certifications; 2-17 (2) adopt rules for the administration of this 2-18 subchapter; and 2-19 (3) take other action necessary to enforce this 2-20 subchapter. 2-21 (b) The board shall apply under the Mammography Quality 2-22 Standards Act of 1992 (42 U.S.C. Section 354) to carry out the 2-23 certification program requirements and to implement the standards 2-24 established by the United States Secretary of Health under that Act 2-25 in this state. If the United States Secretary of Health grants the 2-26 board's application, the board shall assume those responsibilities. 2-27 Sec. 401.424. MAMMOGRAPHY CERTIFICATION STANDARDS. (a) To 3-1 receive a mammography certification under this subchapter, the 3-2 mammography system must, at a minimum: 3-3 (1) meet criteria at least as stringent as the 3-4 American College of Radiology mammography accreditation program; 3-5 (2) be specifically designed and used for the 3-6 performance of mammography; 3-7 (3) be operated by an individual certified as a 3-8 medical radiologic technologist under Chapter 1096, Acts of the 3-9 70th Legislature, Regular Session, 1987 (Article 4512m, Vernon's 3-10 Texas Civil Statutes), who has successfully completed special 3-11 training in mammography; and 3-12 (4) be used in a facility that: 3-13 (A) meets, at minimum, the requirements for 3-14 certification of the Mammography Quality Standards Act of 1992 (42 3-15 U.S.C. Section 354); 3-16 (B) has a licensed medical physicist specialized 3-17 in radiology under Chapter 235, Acts of the 72nd Legislature, 3-18 Regular Session, 1991 (Article 4512n, Vernon's Texas Civil 3-19 Statutes), who at least annually provides on-site consultation to 3-20 the facility, including a complete evaluation of the entire 3-21 mammography system to ensure compliance with this subchapter; 3-22 (C) maintains records of the consultations 3-23 required under Paragraph (B) for not less than seven years after 3-24 the date the consultation was performed; 3-25 (D) establishes a quality control program that 3-26 meets requirements that are at least as stringent as those of the 3-27 American College of Radiology mammography accreditation program; 4-1 and 4-2 (E) maintains and makes available to a patient 4-3 of the facility original mammograms performed at the facility until 4-4 the earlier of: 4-5 (i) the fifth anniversary of the 4-6 mammography; 4-7 (ii) if an additional mammogram of the 4-8 same patient is not performed by the facility, the 10th anniversary 4-9 of the mammography; or 4-10 (iii) at the request of the patient, the 4-11 patient's medical records are forwarded to another medical 4-12 institution. 4-13 (b) To protect the public health, the board by rule may 4-14 adopt more stringent or additional requirements for: 4-15 (1) the certification of mammography systems; and 4-16 (2) the retention of original mammograms. 4-17 (c) To protect the public health, the board by rule shall 4-18 adopt qualifications for a physician who reads, evaluates, and 4-19 interprets a mammogram that are no less stringent than the 4-20 standards of the American College of Radiology. 4-21 (d) The board shall make available to the public copies of 4-22 the criteria of the American College of Radiology mammography 4-23 accreditation program or the modified criteria adopted by board 4-24 rule. 4-25 (e) Notwithstanding any other provision of this chapter, the 4-26 standards imposed for certification under this chapter may not be 4-27 less stringent than the standards imposed on a facility under the 5-1 Mammography Quality Standards Act of 1992 (42 U.S.C. Section 354). 5-2 Sec. 401.425. ALTERNATIVE CERTIFICATION; EXEMPTIONS. 5-3 (a) The department shall issue a certification under this 5-4 subchapter for a mammography system for which the department is 5-5 provided proof of accreditation by the American College of 5-6 Radiology or another recognized organization that has standards no 5-7 less stringent than the standards of the American College of 5-8 Radiology. 5-9 (b) A mammography system issued a certification under this 5-10 section is exempt from the certification standards established by 5-11 or under Section 401.424 and the inspection requirements 5-12 established by or under Section 401.430. 5-13 (c) If the board finds that application of this section 5-14 would make the requirements of this chapter less stringent than the 5-15 standards applicable under the Mammography Quality Standards Act of 5-16 1992 (42 U.S.C. Section 354), the board may not issue a 5-17 certification under this section. 5-18 Sec. 401.426. APPLICATION FOR CERTIFICATION. (a) A person 5-19 who owns, leases, or uses or the agent of a person who owns, 5-20 leases, or uses a mammography system must file a written 5-21 application for certification under Section 401.424 or Section 5-22 401.425 on a form prescribed by the board. 5-23 (b) The department may require, at any time after an 5-24 application is filed, further information from the applicant and 5-25 conduct inspections necessary to determine whether the application 5-26 for certification should be granted or denied. 5-27 Sec. 401.427. CERTIFICATION RENEWAL. (a) A certification 6-1 is valid for one year and may be renewed annually on payment of the 6-2 required renewal fee. 6-3 (b) The board by rule may adopt a system under which 6-4 certifications under this subchapter expire on various dates during 6-5 the year. 6-6 (c) If a certification holder fails to renew the 6-7 certification by the required date, the certification holder may 6-8 renew the certification on payment of the renewal fee and a late 6-9 fee set by the board. If the certification is not renewed before 6-10 the 181st day after the date on which the certification expired, 6-11 the certification holder must apply for an original certification 6-12 under this subchapter. 6-13 (d) A mammography system may not be used after the 6-14 expiration date of the certification unless the holder of the 6-15 expired certification has made a timely and sufficient application 6-16 for renewal of the certification as provided under Section 18, 6-17 Administrative Procedure and Texas Register Act (Article 6252-13a, 6-18 Vernon's Texas Civil Statutes), and a final determination of the 6-19 application by the board has not been made. 6-20 Sec. 401.428. DENIAL, SUSPENSION, REVOCATION, OR 6-21 REINSTATEMENT OF CERTIFICATION. (a) The department may deny, 6-22 suspend, revoke, or reinstate a certification. 6-23 (b) The board shall adopt rules establishing the grounds for 6-24 denial, suspension, revocation, or reinstatement of a certification 6-25 and establishing procedures for disciplinary actions. 6-26 (c) Proceedings relating to the suspension or revocation of 6-27 a certification issued under this subchapter are subject to the 7-1 Administrative Procedure and Texas Register Act (Article 6252-13a, 7-2 Vernon's Texas Civil Statutes). 7-3 (d) A person whose certification has been revoked may apply 7-4 for a new certification on the expiration of one year after the 7-5 date the certification was revoked. 7-6 Sec. 401.429. CERTIFICATION FOR MULTIPLE MAMMOGRAPHY 7-7 SYSTEMS. (a) An applicant for certification under Section 401.426 7-8 must obtain a separate certification for each mammography system 7-9 that is owned, leased, or used by the applicant. 7-10 (b) Certification of multiple mammography systems by a 7-11 single applicant may be recorded on a single certification 7-12 document. If multiple mammography systems are recorded on a single 7-13 certification document, each specific machine certified, if any, 7-14 must be identified on the certification document by referring to 7-15 the machine's manufacturer, model number, and serial number. 7-16 Sec. 401.430. INSPECTIONS. (a) The department shall 7-17 inspect each mammography system that receives a certification under 7-18 this subchapter not later than the 60th day after the date the 7-19 certification is issued. 7-20 (b) The department shall inspect, at least once annually, 7-21 each mammography system that receives a certification. 7-22 (c) To protect the public health, the department may conduct 7-23 more frequent inspections than required under this section. 7-24 (d) The department shall make reasonable attempts to 7-25 coordinate inspections under this section with other inspections 7-26 required under this chapter for the facility where the mammography 7-27 system is used. 8-1 (e) After each satisfactory inspection, the department shall 8-2 issue a certificate of inspection for each mammography system 8-3 inspected. The certificate of inspection must be posted at a 8-4 conspicuous place on or near the place where the mammography system 8-5 is used. The certificate of inspection shall: 8-6 (1) specifically identify the mammography system 8-7 inspected; 8-8 (2) state the name and address of the facility where 8-9 the mammography system was used at the time of the inspection; and 8-10 (3) state the date of the inspection. 8-11 (f) A notice of a mammography system's failure to satisfy 8-12 department standards shall be posted: 8-13 (1) on the mammography system at a conspicuous place 8-14 if the system is a machine; or 8-15 (2) near the place where the mammography system 8-16 practices if the system is an individual. 8-17 (g) To protect the public health, the board may adopt rules 8-18 concerning the grounds for posting a failure notice and the 8-19 placement and size of the failure notice, and for patient 8-20 notification, as appropriate. 8-21 Sec. 401.431. TRANSITION. (a) A mammography system is not 8-22 required to have a certification under this subchapter until 8-23 July 1, 1994. 8-24 (b) Section 401.422 takes effect July 1, 1994. 8-25 (c) The board shall adopt rules under this subchapter not 8-26 later than January 1, 1994. 8-27 (d) This section expires January 1, 1996. 9-1 SECTION 2. The importance of this legislation and the 9-2 crowded condition of the calendars in both houses create an 9-3 emergency and an imperative public necessity that the 9-4 constitutional rule requiring bills to be read on three several 9-5 days in each house be suspended, and this rule is hereby suspended, 9-6 and that this Act take effect and be in force from and after its 9-7 passage, and it is so enacted.