BG C.S.H.B. 1534 75(R)BILL ANALYSIS PUBLIC HEALTH C.S.H.B. 1534 By: Hamric 4-17-97 Committee Report (Substituted) BACKGROUND A mammogram is a radiological process used to detect the presence of pathological conditions of the breast. In 1993, the Texas Legislature passed HB 63 which established a system of regulating mammography devices and the practice of mammography. Before then, there was little oversight of what is considered to be a difficult diagnostic test. HB 63 established a system of certification to ensure quality control of personnel, equipment and procedures employed in the performance and interpretation of mammographic procedures and data. At approximately the same time the Texas Legislature was considering HB 63, the United States Congress adopted a similar law that mandated certain mammography standards be complied with by all states. Because both the federal and state laws were going through the legislative process simultaneously, it was not possible for the Texas Legislature to anticipate all of the provisions that would be contained in the federal law when it was finally adopted. PURPOSE CSHB 1534 brings Texas law into conformity with the federal law. Additionally, the bill provides that notice be given to those women receiving mammograms at facilities which fail to satisfy the board's certification standards. RULEMAKING AUTHORITY It is the committee's opinion that in SECTION 5 this bill grants additional rulemaking authority for the Texas Board of Health (Section 401.430(i), Health and Safety Code) in terms of patient notification of failure to satisfy board certification standards under Sec. 401.430(g) and (h). Also rulemaking authority for TDH is referenced in Sec. 401.430(g). SECTION BY SECTION ANALYSIS SECTION 1. Amends Section 401.423(b), Health and Safety Code, by replacing "board" with "department," and requiring the Texas Department of Health to apply to become an accreditation body under the Mammography Quality Standards Act of 1992. Amends reference from Section "354" to "263b" to reflect the change in location in the United States Code. SECTION 2. Amends Section 401.424(a) and (e), Health and Safety Code, by making conforming changes, replacing the reference to Sec. "354" as above, and adding language to clarify minimum requirements for personnel as specified and the length of time mammograms must be kept by a facility in order to conform with federal rules. SECTION 3. Amends Section 401.426(a), Health and Safety Code, by deleting reference to Section 401.425, which has been repealed. SECTION 4. Amends Section 401.427, Health and Safety Code, by renaming the heading and adding language and a subsection as follows: Sec. 401.427. CERTIFICATION RENEWAL; FEES. Subsection (a) revises the length of time that a certification is valid from one year to three years in order to conform with federal law. Subsection (c) requires the board to set and collect an annual fee as specified. Requires late fees to be paid as specified. Allows the board to revoke the certification of a certification holder who does not pay the annual fee and late fee before the required date. Subsection (d) allows a certification holder to renew the certification by filing an application and paying the fee as specified. Replaces the term "renewal" fee with "annual" fee. Subsection (e). makes a conforming change for relettering. SECTION 5. Amends Section 401.430, Health and Safety Code, is amended as follows: Sec. 401.430. Inspections. Subsection (a) revises language in the requirement regarding TDH inspections of each mammography system to specify those that have not been fully certified under the Mammography Quality Standards Act of 1992. Makes conforming change. Subsection (b) clarifies the requirement concerning at least annual TDH inspections to specify mammography systems that receive certification "under this subchapter." Subsection (g) requires the facility whose mammography system fails to meet TDH certification standards, and the failure is a Severity Level I violation under TDH rules, to notify each patient who was tested during the 30 days preceding the date the facility received notice of the failure. Requires the facility to inform the patient that the facility failed inspection, recommend that the patient receive another mammogram at a certified facility, and list the three certified facilities closest to the original testing facility. Subsection (h) allows TDH to require facilities to notify a patient of any other certification standards failure, in addition to the subsection (g) requirement. Subsection (i) makes conforming change to allow for the adoption of rules concerning patient notification under Subsections (g) and (h). SECTION 6. Repeals Section 401.425, Health and Safety Code. SECTION 7. Establishes that this Act takes effect September 1, 1997. SECTION 8. Emergency Clause. COMPARISON OF ORIGINAL TO SUBSTITUTE The committee substitute changes HB 1534 in SECTION 2 (Section 401.424(a)(3), Health and Safety Code) by replacing "has successfully completed special training in mammography" with "meets, at a minimum, the requirements for personnel who perform mammography established by the Mammography Quality Standards Act of 1992" in order to conform state law to the federal standards. Also changed is SECTION 5 (Section 401.430(g), (h) and (i), Health and Safety Code). CSHB 1534 amends the requirement involving notification of patients who receive mammograms from facilities that fail to satisfy department standards, so that only those facilities that commit a Severity Level I violation are required by law to notify patients as specified in subsection (g). The substitute bill inserts a new subsection (h) to permit TDH to require patient notification for any other failure of a facility's mammography system; and then CSHB 1534's subsection (i) is the original bill's subsection (h) relettered to conform and with the additional reference made for patient notification under subsection (h) as well as subsection (g).