[Congressional Record Volume 143, Number 157 (Sunday, November 9, 1997)]
[Senate]
[Pages S12423-S12424]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




           MAMMOGRAPHY QUALITY STANDARDS REAUTHORIZATION ACT

  Mr. SESSIONS. I ask unanimous consent that the Labor and Human 
Resources Committee be discharged from further consideration of S. 537 
and that the Senate then proceed to its immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The legislative clerk read as follows:

       A bill (S. 537) to amend title III of the Public Health 
     Service Act to revise and extend the mammography quality 
     standards program.

  The PRESIDING OFFICER. Is there objection to the immediate 
consideration of the bill?
  There being no objection, the Senate proceeded to consider the bill.
  Mr. SESSIONS. I ask unanimous consent the bill be read three times 
and passed, the motion to reconsider be laid upon the table, and any 
statements relating thereto be printed in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The bill (S. 537) was deemed read the third time and passed, as 
follows:

                                 S. 537

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Mammography Quality 
     Standards Reauthorization Act''.

     SEC. 2. AUTHORIZATION OF APPROPRIATIONS.

       (a) In General.--Subparagraphs (A) and (B) of section 
     354(r)(2) of the Public Health Service Act (42 U.S.C. 
     263b(r)(2) (A) and (B)) are each amended by striking ``1997'' 
     and inserting ``2002''.
       (b) Technical Amendment.--Section 354(r)(2)(A) of the 
     Public Health Service Act (42 U.S.C. 263b(r)(2)(A)) is 
     amended by striking ``subsection (q)'' and inserting 
     ``subsection (p)''.

     SEC. 3. APPLICATION OF CURRENT VERSION OF APPEAL REGULATIONS.

       Section 354(d)(2)(B) of the Public Health Service Act (42 
     U.S.C. 263b(d)(2)(B)) is

[[Page S12424]]

     amended by striking ``and in effect on the date of enactment 
     of this section''.

     SEC. 4. CLARIFICATION OF FACILITIES' RESPONSIBILITY TO RETAIN 
                   MAMMOGRAM RECORDS.

       Section 354(f)(1)(G) of the Public Health Service Act (42 
     U.S.C. 263b(f)(1)(G)) is amended by striking clause (i) and 
     inserting the following:
       ``(i) a facility that performs any mammogram--
       ``(I) except as provided in subclause (II), maintain the 
     mammogram in the permanent medical records of the patient for 
     a period of not less than 5 years, or not less than 10 years 
     if no additional mammograms of such patient are performed at 
     the facility, or longer if mandated by State law; and
       ``(II) upon the request of or on behalf of the patient, 
     forward the mammogram to a medical institution or a physician 
     of the patient; and''.

     SEC. 5. SCOPE OF INSPECTIONS.

       Section 354(g)(1)(A) of the Public Health Service Act (42 
     U.S.C. 263b(g)(1)(A)) is amended in the first sentence--
       (1) by striking ``certified''; and
       (2) by inserting ``the certification requirements under 
     subsection (b) and'' after ``compliance with''.

     SEC. 6. 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 it appears;
       (2) in the heading of subsection (g)(3), by inserting ``or 
     local'' after ``state''; and
       (3) in subsection (i)(1)(D)--
       (A) by inserting ``or local'' after ``State'' the first 
     place it appears; and
       (B) by inserting ``or local agency'' after ``State'' the 
     second place it appears.

     SEC. 7. 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 so 
     redesignated, 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''

     SEC. 8. REQUIREMENT TO COMPLY WITH INFORMATION REQUESTS.

       Section 354(i)(1)(C) of the Public Health Service Act (42 
     U.S.C. 263b(i)(1)(C)) is amended--
       (1) by inserting after ``Secretary'', the first place it 
     appears ``(or of an accreditation body approved pursuant to 
     subsection (e))''; and
       (2) by inserting after ``Secretary'', the second place it 
     appears ``(or such accreditation body or certifying 
     entity)''.

     SEC. 9. ADJUSTMENT TO SEVERITY OF SANCTIONS.

       Section 354(i)(2)(A) of the Public Health Service Act (42 
     U.S.C. 263b(i)(2)(A)) is amended by striking ``makes the 
     finding'' and all that follows and inserting the following: 
     ``has reason to believe that the circumstance of the case 
     will support one or more of the findings described in 
     paragraph (1) and that--
       ``(i) the failure or violation was intentional, or
       ``(ii) the failure or violation presents a serious risk to 
     human health.''.

     SEC. 10. TECHNICAL AMENDMENT.

       Section 354(q)(4)(B) of the Public Health Service Act (42 
     U.S.C. 263b(q)(4)(B)) is amended by striking ``accredited'' 
     and inserting ``certified''.

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