1-1 By: Hamric, McCall (Senate Sponsor - Zaffirini) H.B. No. 1534
1-2 Danburg
1-3 (In the Senate - Received from the House May 6, 1997;
1-4 May 7, 1997, read first time and referred to Committee on Health
1-5 and Human Services; May 14, 1997, reported favorably by the
1-6 following vote: Yeas 10, Nays 0; May 14, 1997, sent to printer.)
1-7 A BILL TO BE ENTITLED
1-8 AN ACT
1-9 relating to the certification of mammography systems.
1-10 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-11 SECTION 1. Section 401.423(b), Health and Safety Code, is
1-12 amended to read as follows:
1-13 (b) The department [board] shall apply under the Mammography
1-14 Quality Standards Act of 1992 (42 U.S.C. Section 263b [354]) to
1-15 become an accreditation body and carry out the certification
1-16 program requirements and to implement the standards established by
1-17 the United States Secretary of Health under that Act in this state.
1-18 If the United States Secretary of Health grants the department's
1-19 [board's] application, the department [board] shall assume those
1-20 responsibilities.
1-21 SECTION 2. Sections 401.424(a) and (e), Health and Safety
1-22 Code, are amended to read as follows:
1-23 (a) To receive a mammography certification under this
1-24 subchapter, the mammography system must, at a minimum:
1-25 (1) meet criteria at least as stringent as the
1-26 American College of Radiology mammography accreditation program;
1-27 (2) be specifically designed and used for the
1-28 performance of mammography;
1-29 (3) be operated by an individual certified as a
1-30 medical radiologic technologist under Chapter 1096, Acts of the
1-31 70th Legislature, Regular Session, 1987 (Article 4512m, Vernon's
1-32 Texas Civil Statutes), who meets, at a minimum, the requirements
1-33 for personnel who perform mammography established by the
1-34 Mammography Quality Standards Act of 1992 (42 U.S.C. Section 263b)
1-35 [has successfully completed special training in mammography]; and
1-36 (4) be used in a facility that:
1-37 (A) meets, at minimum, the requirements for
1-38 certification of the Mammography Quality Standards Act of 1992 (42
1-39 U.S.C. Section 263b [354]);
1-40 (B) has a licensed medical physicist specialized
1-41 in radiology under Chapter 235, Acts of the 72nd Legislature,
1-42 Regular Session, 1991 (Article 4512n, Vernon's Texas Civil
1-43 Statutes), who at least annually provides on-site consultation to
1-44 the facility, including a complete evaluation of the entire
1-45 mammography system to ensure compliance with this subchapter;
1-46 (C) maintains records of the consultations
1-47 required under Paragraph (B) for not less than seven years after
1-48 the date the consultation was performed;
1-49 (D) establishes a quality control program that
1-50 meets requirements that are at least as stringent as those of the
1-51 American College of Radiology mammography accreditation program;
1-52 and
1-53 (E) maintains and makes available to a patient
1-54 of the facility original mammograms performed at the facility until
1-55 the earlier of either:
1-56 (i) the fifth anniversary of the
1-57 mammography or,[;]
1-58 [(ii)] if an additional mammogram of the
1-59 same patient is not performed by the facility, the 10th anniversary
1-60 of the mammography; or
1-61 (ii) [(iii)] at the request of the
1-62 patient, the date the patient's medical records are forwarded to
1-63 another medical institution.
1-64 (e) Notwithstanding any other provision of this chapter, the
2-1 standards imposed for certification under this chapter may not be
2-2 less stringent than the standards imposed on a facility under the
2-3 Mammography Quality Standards Act of 1992 (42 U.S.C. Section 263b
2-4 [354]).
2-5 SECTION 3. Section 401.426(a), Health and Safety Code, is
2-6 amended to read as follows:
2-7 (a) A person who owns, leases, or uses or the agent of a
2-8 person who owns, leases, or uses a mammography system must file a
2-9 written application for certification under Section 401.424 [or
2-10 Section 401.425] on a form prescribed by the board.
2-11 SECTION 4. Section 401.427, Health and Safety Code, is
2-12 amended to read as follows:
2-13 Sec. 401.427. CERTIFICATION RENEWAL; FEES. (a) A
2-14 certification is valid for three years [one year and may be renewed
2-15 annually on payment of the required renewal fee].
2-16 (b) The board by rule may adopt a system under which
2-17 certifications under this subchapter expire on various dates during
2-18 the year.
2-19 (c) The board shall set and collect an annual fee for
2-20 certification holders in an amount reasonable and necessary to
2-21 administer this subchapter. A certification holder who fails to
2-22 pay the annual fee before the date set by the board shall pay the
2-23 annual fee and a late fee set by the board. The board may revoke
2-24 the certification of a certification holder who does not pay the
2-25 annual fee and late fee before the required date.
2-26 (d) A certification holder may renew the certification by
2-27 filing an application for renewal and paying the annual fee before
2-28 the date the certification expires. If a certification holder
2-29 fails to renew the certification by the required date, the
2-30 certification holder may renew the certification on payment of the
2-31 annual [renewal] fee and a late fee set by the board. If the
2-32 certification is not renewed before the 181st day after the date on
2-33 which the certification expired, the certification holder must
2-34 apply for an original certification under this subchapter.
2-35 (e) [(d)] A mammography system may not be used after the
2-36 expiration date of the certification unless the holder of the
2-37 expired certification has made a timely and sufficient application
2-38 for renewal of the certification as provided under Section
2-39 2001.054, Government Code, and a final determination of the
2-40 application by the board has not been made.
2-41 SECTION 5. Section 401.430, Health and Safety Code, is
2-42 amended to read as follows:
2-43 Sec. 401.430. INSPECTIONS. (a) The department shall
2-44 inspect each mammography system that has not been fully certified
2-45 under the Mammography Quality Standards Act of 1992 (42 U.S.C.
2-46 Section 263b) [receives a certification under this subchapter] not
2-47 later than the 60th day after the date the certification under this
2-48 subchapter is issued.
2-49 (b) The department shall inspect, at least once annually,
2-50 each mammography system that receives a certification under this
2-51 subchapter.
2-52 (c) To protect the public health, the department may conduct
2-53 more frequent inspections than required under this section.
2-54 (d) The department shall make reasonable attempts to
2-55 coordinate inspections under this section with other inspections
2-56 required under this chapter for the facility where the mammography
2-57 system is used.
2-58 (e) After each satisfactory inspection, the department shall
2-59 issue a certificate of inspection for each mammography system
2-60 inspected. The certificate of inspection must be posted at a
2-61 conspicuous place on or near the place where the mammography system
2-62 is used. The certificate of inspection shall:
2-63 (1) specifically identify the mammography system
2-64 inspected;
2-65 (2) state the name and address of the facility where
2-66 the mammography system was used at the time of the inspection; and
2-67 (3) state the date of the inspection.
2-68 (f) A notice of a mammography system's failure to satisfy
2-69 department standards shall be posted:
3-1 (1) on the mammography system at a conspicuous place
3-2 if the system is a machine; or
3-3 (2) near the place where the mammography system
3-4 practices if the system is an individual.
3-5 (g) If a facility's mammography system fails to meet the
3-6 department's certification standards and the failure is a Severity
3-7 Level I violation under the department's rules, the facility shall
3-8 notify each patient on whom the facility performed a mammography
3-9 during the 30 days preceding the date of the inspection that
3-10 revealed the failure. The facility shall:
3-11 (1) inform the patient that the mammography system
3-12 failed to satisfy the department's certification standards;
3-13 (2) recommend that the patient have another mammogram
3-14 performed at a facility with a certified mammography system; and
3-15 (3) list the three facilities closest to the original
3-16 testing facility that have a certified mammography system.
3-17 (h) In addition to the requirement of Subsection (g), the
3-18 department may require a facility to notify a patient of any other
3-19 failure of the facility's mammography system to meet the
3-20 department's certification standards.
3-21 (i) To protect the public health, the board may adopt rules
3-22 concerning the grounds for posting a failure notice and the
3-23 placement and size of the failure notice, and for patient
3-24 notification under Subsections (g) and (h), as appropriate.
3-25 SECTION 6. Section 401.425, Health and Safety Code, is
3-26 repealed.
3-27 SECTION 7. This Act takes effect September 1, 1997.
3-28 SECTION 8. The importance of this legislation and the
3-29 crowded condition of the calendars in both houses create an
3-30 emergency and an imperative public necessity that the
3-31 constitutional rule requiring bills to be read on three several
3-32 days in each house be suspended, and this rule is hereby suspended.
3-33 * * * * *