By Hamric H.B. No. 1534
75R6715 MCK-D
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to the certification of mammography systems.
1-3 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-4 SECTION 1. Section 401.423(b), Health and Safety Code, is
1-5 amended to read as follows:
1-6 (b) The department [board] shall apply under the Mammography
1-7 Quality Standards Act of 1992 (42 U.S.C. Section 263b [354]) to
1-8 become an accreditation body and carry out the certification
1-9 program requirements and to implement the standards established by
1-10 the United States Secretary of Health under that Act in this state.
1-11 If the United States Secretary of Health grants the department's
1-12 [board's] application, the department [board] shall assume those
1-13 responsibilities.
1-14 SECTION 2. Sections 401.424(a) and (e), Health and Safety
1-15 Code, are amended to read as follows:
1-16 (a) To receive a mammography certification under this
1-17 subchapter, the mammography system must, at a minimum:
1-18 (1) meet criteria at least as stringent as the
1-19 American College of Radiology mammography accreditation program;
1-20 (2) be specifically designed and used for the
1-21 performance of mammography;
1-22 (3) be operated by an individual certified as a
1-23 medical radiologic technologist under Chapter 1096, Acts of the
1-24 70th Legislature, Regular Session, 1987 (Article 4512m, Vernon's
2-1 Texas Civil Statutes), who has successfully completed special
2-2 training in mammography; and
2-3 (4) be used in a facility that:
2-4 (A) meets, at minimum, the requirements for
2-5 certification of the Mammography Quality Standards Act of 1992 (42
2-6 U.S.C. Section 263b [354]);
2-7 (B) has a licensed medical physicist specialized
2-8 in radiology under Chapter 235, Acts of the 72nd Legislature,
2-9 Regular Session, 1991 (Article 4512n, Vernon's Texas Civil
2-10 Statutes), who at least annually provides on-site consultation to
2-11 the facility, including a complete evaluation of the entire
2-12 mammography system to ensure compliance with this subchapter;
2-13 (C) maintains records of the consultations
2-14 required under Paragraph (B) for not less than seven years after
2-15 the date the consultation was performed;
2-16 (D) establishes a quality control program that
2-17 meets requirements that are at least as stringent as those of the
2-18 American College of Radiology mammography accreditation program;
2-19 and
2-20 (E) maintains and makes available to a patient
2-21 of the facility original mammograms performed at the facility until
2-22 the earlier of either:
2-23 (i) the fifth anniversary of the
2-24 mammography or,[;]
2-25 [(ii)] if an additional mammogram of the
2-26 same patient is not performed by the facility, the 10th anniversary
2-27 of the mammography; or
3-1 (ii) [(iii)] at the request of the
3-2 patient, the date the patient's medical records are forwarded to
3-3 another medical institution.
3-4 (e) Notwithstanding any other provision of this chapter, the
3-5 standards imposed for certification under this chapter may not be
3-6 less stringent than the standards imposed on a facility under the
3-7 Mammography Quality Standards Act of 1992 (42 U.S.C. Section 263b
3-8 [354]).
3-9 SECTION 3. Section 401.426(a), Health and Safety Code, is
3-10 amended to read as follows:
3-11 (a) A person who owns, leases, or uses or the agent of a
3-12 person who owns, leases, or uses a mammography system must file a
3-13 written application for certification under Section 401.424 [or
3-14 Section 401.425] on a form prescribed by the board.
3-15 SECTION 4. Section 401.427, Health and Safety Code, is
3-16 amended to read as follows:
3-17 Sec. 401.427. CERTIFICATION RENEWAL; FEES. (a) A
3-18 certification is valid for three years [one year and may be renewed
3-19 annually on payment of the required renewal fee].
3-20 (b) The board by rule may adopt a system under which
3-21 certifications under this subchapter expire on various dates during
3-22 the year.
3-23 (c) The board shall set and collect an annual fee for
3-24 certification holders in an amount reasonable and necessary to
3-25 administer this subchapter. A certification holder who fails to
3-26 pay the annual fee before the date set by the board shall pay the
3-27 annual fee and a late fee set by the board. The board may revoke
4-1 the certification of a certification holder who does not pay the
4-2 annual fee and late fee before the required date.
4-3 (d) A certification holder may renew the certification by
4-4 filing an application for renewal and paying the annual fee before
4-5 the date the certification expires. If a certification holder
4-6 fails to renew the certification by the required date, the
4-7 certification holder may renew the certification on payment of the
4-8 annual [renewal] fee and a late fee set by the board. If the
4-9 certification is not renewed before the 181st day after the date on
4-10 which the certification expired, the certification holder must
4-11 apply for an original certification under this subchapter.
4-12 (e) [(d)] A mammography system may not be used after the
4-13 expiration date of the certification unless the holder of the
4-14 expired certification has made a timely and sufficient application
4-15 for renewal of the certification as provided under Section
4-16 2001.054, Government Code, and a final determination of the
4-17 application by the board has not been made.
4-18 SECTION 5. Section 401.430, Health and Safety Code, is
4-19 amended to read as follows:
4-20 Sec. 401.430. INSPECTIONS. (a) The department shall
4-21 inspect each mammography system that has not been fully certified
4-22 under the Mammography Quality Standards Act of 1992 (42 U.S.C.
4-23 Section 263b) [receives a certification under this subchapter] not
4-24 later than the 60th day after the date the certification under this
4-25 subchapter is issued.
4-26 (b) The department shall inspect, at least once annually,
4-27 each mammography system that receives a certification under this
5-1 subchapter.
5-2 (c) To protect the public health, the department may conduct
5-3 more frequent inspections than required under this section.
5-4 (d) The department shall make reasonable attempts to
5-5 coordinate inspections under this section with other inspections
5-6 required under this chapter for the facility where the mammography
5-7 system is used.
5-8 (e) After each satisfactory inspection, the department shall
5-9 issue a certificate of inspection for each mammography system
5-10 inspected. The certificate of inspection must be posted at a
5-11 conspicuous place on or near the place where the mammography system
5-12 is used. The certificate of inspection shall:
5-13 (1) specifically identify the mammography system
5-14 inspected;
5-15 (2) state the name and address of the facility where
5-16 the mammography system was used at the time of the inspection; and
5-17 (3) state the date of the inspection.
5-18 (f) A notice of a mammography system's failure to satisfy
5-19 department standards shall be posted:
5-20 (1) on the mammography system at a conspicuous place
5-21 if the system is a machine; or
5-22 (2) near the place where the mammography system
5-23 practices if the system is an individual.
5-24 (g) If a facility's mammography system fails to satisfy the
5-25 board's certification standards, the facility shall notify each
5-26 patient on whom the facility performed a mammography during the 30
5-27 days preceding the date the facility received notice of the
6-1 failure. The facility shall:
6-2 (1) inform the patient that the mammography system
6-3 failed to satisfy the department's certification standards;
6-4 (2) recommend that the patient have another mammogram
6-5 performed at a facility with a certified mammography system; and
6-6 (3) list the three facilities closest to the original
6-7 testing facility that have a certified mammography system.
6-8 (h) To protect the public health, the board may adopt rules
6-9 concerning the grounds for posting a failure notice and the
6-10 placement and size of the failure notice, and for patient
6-11 notification under Subsection (g), as appropriate.
6-12 SECTION 6. Section 401.425, Health and Safety Code, is
6-13 repealed.
6-14 SECTION 7. This Act takes effect September 1, 1997.
6-15 SECTION 8. The importance of this legislation and the
6-16 crowded condition of the calendars in both houses create an
6-17 emergency and an imperative public necessity that the
6-18 constitutional rule requiring bills to be read on three several
6-19 days in each house be suspended, and this rule is hereby suspended.