Texas Statutes
Subchapter L. Certification of Mammography Systems
Section 401.430. Inspections

Sec. 401.430. INSPECTIONS. (a) The department shall inspect each mammography system that has not been fully certified under the Mammography Quality Standards Act of 1992 (42 U.S.C. Section 263b) not later than the 60th day after the date the certification under this subchapter is issued.
(b) The executive commissioner by rule shall establish the routine inspection frequency for mammography systems that receive certification under this subchapter.
(c) The department shall make reasonable attempts to coordinate inspections under this section with other inspections required under this chapter for the facility where the mammography system is used.
(d) After each satisfactory inspection, the department shall issue a certificate of inspection for each mammography system inspected. The certificate of inspection must be posted at a conspicuous place on or near the place where the mammography system is used. The certificate of inspection shall:
(1) specifically identify the mammography system inspected;
(2) state the name and address of the facility where the mammography system was used at the time of the inspection; and
(3) state the date of the inspection.
(e) A notice of a mammography system's failure to satisfy department standards shall be posted:
(1) on the mammography system at a conspicuous place if the system is a machine; or
(2) near the place where the mammography system practices if the system is an individual.
(f) If a facility's mammography system fails to meet the department's certification standards and the failure is a Severity Level I violation under the department's rules, the facility shall notify each patient on whom the facility performed a mammography during the period in which the system failed to meet the department's certification standards. The facility shall:
(1) inform the patient that the mammography system failed to satisfy the department's certification standards;
(2) recommend that the patient consult with the patient's physician regarding the need for another mammogram; and
(3) list the three facilities closest to the original testing facility that have a certified mammography system.
(g) In addition to the requirement of Subsection (f), the department may require a facility to notify a patient of any other failure of the facility's mammography system to meet the department's certification standards.
(h) To protect the public health, the executive commissioner may adopt rules concerning the grounds for posting a failure notice and the placement and size of the failure notice, and for patient notification under Subsections (f) and (g), as appropriate.
Added by Acts 1993, 73rd Leg., ch. 138, Sec. 1, eff. Aug. 30, 1993. Amended by Acts 1997, 75th Leg., ch. 759, Sec. 5, eff. Sept. 1, 1997; Acts 2001, 77th Leg., ch. 1009, Sec. 9, eff. Sept. 1, 2001.
Amended by:
Acts 2009, 81st Leg., R.S., Ch. 1355 (S.B. 527), Sec. 1, eff. September 1, 2009.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0939, eff. April 2, 2015.