75R10498 MCK-D                           

         By Hamric, McCall                                     H.B. No. 1534

         Substitute the following for H.B. No. 1534:

         By Berlanga                                       C.S.H.B. No. 1534

                                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 meets, at a minimum, the requirements

 2-2     for personnel who perform mammography established by the

 2-3     Mammography Quality Standards Act of 1992 (42 U.S.C. Section 263b)

 2-4     [has successfully completed special training in mammography]; and

 2-5                 (4)  be used in a facility that:

 2-6                       (A)  meets, at minimum, the requirements for

 2-7     certification of the Mammography Quality Standards Act of 1992 (42

 2-8     U.S.C. Section 263b [354]);

 2-9                       (B)  has a licensed medical physicist specialized

2-10     in radiology under Chapter 235, Acts of the 72nd Legislature,

2-11     Regular Session, 1991 (Article 4512n, Vernon's Texas Civil

2-12     Statutes), who at least annually provides on-site consultation to

2-13     the facility, including a complete evaluation of the entire

2-14     mammography system to ensure compliance with this subchapter;

2-15                       (C)  maintains records of the consultations

2-16     required under Paragraph (B) for not less than seven years after

2-17     the date the consultation was performed;

2-18                       (D)  establishes a quality control program that

2-19     meets requirements that are at least as stringent as those of the

2-20     American College of Radiology mammography accreditation program;

2-21     and

2-22                       (E)  maintains and makes available to a patient

2-23     of the facility original mammograms performed at the facility until

2-24     the earlier of either:

2-25                             (i)  the fifth anniversary of the

2-26     mammography or,[;]

2-27                             [(ii)]  if an additional mammogram of the

 3-1     same patient is not performed by the facility, the 10th anniversary

 3-2     of the mammography; or

 3-3                             (ii) [(iii)]  at the request of the

 3-4     patient, the date the patient's medical records are forwarded to

 3-5     another medical institution.

 3-6           (e)  Notwithstanding any other provision of this chapter, the

 3-7     standards imposed for certification under this chapter may not be

 3-8     less stringent than the standards imposed on a facility under the

 3-9     Mammography Quality Standards Act of 1992 (42 U.S.C. Section 263b

3-10     [354]).

3-11           SECTION 3.  Section 401.426(a), Health and Safety Code, is

3-12     amended to read as follows:

3-13           (a)  A person who owns, leases, or uses or the agent of a

3-14     person who owns, leases, or uses a mammography system must file a

3-15     written application for certification under Section 401.424 [or

3-16     Section 401.425] on a form prescribed by the board.

3-17           SECTION 4.  Section 401.427, Health and Safety Code, is

3-18     amended to read as follows:

3-19           Sec. 401.427.  CERTIFICATION RENEWAL; FEES.  (a) A

3-20     certification is valid for three years [one year and may be renewed

3-21     annually on payment of the required renewal fee].

3-22           (b)  The board by rule may adopt a system under which

3-23     certifications under this subchapter expire on various dates during

3-24     the year.

3-25           (c)  The board shall set and collect an annual fee for

3-26     certification holders in an amount reasonable and necessary to

3-27     administer this subchapter.  A certification holder who fails to

 4-1     pay the annual fee before the date set by the board shall pay the

 4-2     annual fee and a late fee set by the board.  The board may revoke

 4-3     the certification of a certification holder who does not pay the

 4-4     annual fee and late fee before the required date.

 4-5           (d)  A certification holder may renew the certification by

 4-6     filing an application for renewal and paying the annual fee before

 4-7     the date the certification expires.  If a certification  holder

 4-8     fails to renew the certification by the required date, the

 4-9     certification holder may renew the certification on payment of the

4-10     annual [renewal] fee and a late fee set by the board.  If the

4-11     certification is not renewed before the 181st day after the date on

4-12     which the certification expired, the certification holder must

4-13     apply for an original certification under this subchapter.

4-14           (e) [(d)]  A mammography system may not be used after the

4-15     expiration date of the certification unless the holder of the

4-16     expired certification has made a timely and sufficient application

4-17     for renewal of the certification as provided under Section

4-18     2001.054, Government Code, and a final determination of the

4-19     application by the board has not been made.

4-20           SECTION 5.  Section 401.430, Health and Safety Code, is

4-21     amended to read as follows:

4-22           Sec.  401.430.  INSPECTIONS.  (a) The department shall

4-23     inspect each mammography system that has not been fully certified

4-24     under the Mammography Quality Standards Act of 1992 (42 U.S.C.

4-25     Section 263b) [receives a certification under this subchapter] not

4-26     later than the 60th day after the date the certification under this

4-27     subchapter is issued.

 5-1           (b)  The department shall inspect, at least once annually,

 5-2     each mammography system that receives a certification under this

 5-3     subchapter.

 5-4           (c)  To protect the public health, the department may conduct

 5-5     more frequent inspections than required under this section.

 5-6           (d)  The department shall make reasonable attempts to

 5-7     coordinate inspections under this section with other inspections

 5-8     required under this chapter for the facility where the mammography

 5-9     system is used.

5-10           (e)  After each satisfactory inspection, the department shall

5-11     issue a certificate of inspection for each mammography system

5-12     inspected.  The certificate of inspection must be posted at a

5-13     conspicuous place on or near the place where the mammography system

5-14     is used.  The certificate of inspection shall:

5-15                 (1)  specifically identify the mammography system

5-16     inspected;

5-17                 (2)  state the name and address of the facility where

5-18     the mammography system was used at the time of the inspection;  and

5-19                 (3)  state the date of the inspection.

5-20           (f)  A notice of a mammography system's failure to satisfy

5-21     department standards shall be posted:

5-22                 (1)  on the mammography system at a conspicuous place

5-23     if the system is a machine;  or

5-24                 (2)  near the place where the mammography system

5-25     practices if the system is an individual.

5-26           (g)  If a facility's mammography system fails to meet the

5-27     department's certification standards and the failure is a Severity

 6-1     Level I violation under the department's rules, the facility shall

 6-2     notify each patient on whom the facility performed a mammography

 6-3     during the 30 days preceding the date the facility received notice

 6-4     of the failure.  The facility shall:

 6-5                 (1)  inform the patient that the mammography system

 6-6     failed to satisfy the department's certification standards;

 6-7                 (2)  recommend that the patient have another mammogram

 6-8     performed at a facility with a certified mammography system; and

 6-9                 (3)  list the three facilities closest to the original

6-10     testing facility that have a certified mammography system.

6-11           (h)  In addition to the requirement of Subsection (g), the

6-12     department may require a facility to notify a patient of any other

6-13     failure of the facility's mammography system to meet the

6-14     department's certification standards.

6-15           (i)  To protect the public health, the board may adopt rules

6-16     concerning the grounds for posting a failure notice and the

6-17     placement and size of the failure notice, and for patient

6-18     notification under Subsections (g) and (h), as appropriate.

6-19           SECTION 6.  Section 401.425, Health and Safety Code, is

6-20     repealed.

6-21           SECTION 7.  This Act takes effect September 1, 1997.

6-22           SECTION 8.  The importance of this legislation and the

6-23     crowded condition of the calendars in both houses create an

6-24     emergency and an imperative public necessity that the

6-25     constitutional rule requiring bills to be read on three several

6-26     days in each house be suspended, and this rule is hereby suspended.