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.