Page:United States Statutes at Large Volume 112 Part 3.djvu/36

 112 STAT. 1866 PUBLIC LAW 105-248—OCT. 9, 1998 (f). The Secretary may at any time provide that a facility will no longer be included in the program. "(iii) The number of facilities selected for inclusion in the program shall be sufficient to provide a statistically significant sample, subject to compliance with clause (ii). "(iv) Facilities that are selected for inclusion in the program shall be inspected at such intervals as the Secretary determines will reasonably ensure that the facilities are maintaining compliance with such standards.". SEC. 9. CLARIFICATION OF AUTHORITY TO DELEGATE INSPECTION RESPONSIBILITY TO LOCAL GOVERNMENT AGENCIES. Section 354 of the Public Health Service Act (42 U.S.C. 263b) is amended— (1) in subsections (a)(4), (g)(1), (g)(3), and (g)(4), by inserting "or local" after "State" each place such term appears; (2) in the heading of subsection (g)(3), by inserting "OR LOCAL" after "STATE"; and (3) in subsection (i)(l)(D)— (A) by inserting "or local" after "State" the first place such term appears; and (B) by inserting "or local agency" after "State" the second place such term appears. SEC. 10. PATIENT NOTIFICATION CONCERNING HEALTH RISKS. (a) REQUIREMENT.— Section 354(h) of the Public Health Service Act (42 U.S.C. 263b(h)) is amended— (1) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and (2) by inserting after paragraph (1) the following: "(2) PATIENT INFORMATION. — If the Secretary determines that the quality of mammography performed by a facility (whether or not certified pursuant to subsection (c)) was so inconsistent with the quality standards established pursuant to subsection (f) as to present a significant risk to individual or public health, the Secretary may require such facility to notify patients who received mammograms at such facility, and their referring physicians, of the deficiencies presenting such risk, the potential harm resulting, appropriate remedial measures, and such other relevant information as the Secretary may require.". (b) CIVIL MONEY PENALTY.—Section 354(h)(3) of the Public Health Service Act (42 U.S.C. 263b(h)(3)), as redesignated by subsection (a)(1), is amended— (1) by striking "and" at the end of subparagraph (B); (2) by redesignating subparagraph (C) as subparagraph (D); and (3) by inserting after subparagraph (B) the following: "(C) each failure to notify a patient of risk as required by the Secretary pursuant to paragraph (2), and". (c) CONFORMING AMENDMENT.— Section 354(h)(4) of the Public Health Service Act (42 U.S.C. 263b(h)(4)), as redesignated by subsection (a)(1), is amended by striking "paragraphs (1) and (2)" and inserting "paragraphs (1) through (3)".

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