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.