[Congressional Record Volume 153, Number 194 (Tuesday, December 18, 2007)]
[Senate]
[Pages S15920-S15921]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. LANDRIEU (for herself and Mr. Isakson):
  S. 2510. A bill to amend the Public Health Service Act to provide 
revised standards for quality assurance in screening and evaluation of 
gynecologic cytology preparations, and for other purposes; to the 
Committee on Health, Education, Labor, and Pensions.
  Ms. LANDRIEU. Mr. President, I am pleased to introduce today with my 
colleague, Senator Johnny Isakson, the Cytology Proficiency Improvement 
Act of 2007. This bipartisan legislation enhances women's health by 
establishing an annual continuing medical education, CME, proficiency 
requirement for pathologists and laboratory professionals who read Pap 
tests to screen for cervical cancer. The legislation would enhance our 
fight against this disease by giving women confidence in their Pap test 
results. Women in my State of Louisiana and across the country deserve 
no less.
  Specifically, our legislation would require individuals who examine 
Pap test slides to participate annually in an outcome-based CME program 
to evaluate their interpretative skills. This educational testing 
program would keep pace with cutting edge advances in science and 
technology. Health professionals would be challenged with complex, 
difficult cases and would learn through constructive feedback. The bill 
would also require that laboratory directors utilize the CME testing 
results to help assess the performance of their laboratory personnel 
and take corrective action as appropriate. Finally, the bill would 
require that the CME results be reviewed by accrediting organizations 
as part of federally mandated inspections of laboratories to evaluate 
Pap test quality.
  In 1988, Congress requested that a cytology, Pap test, proficiency 
program be established as part of The Clinical Laboratory Improvement 
Amendments, CLIA. However, the program lay dormant until 2005 when the 
Centers for Medicare and Medicaid, CMS, finally implemented a program. 
Unfortunately, the program was implemented using 1992 regulations--now 
15 years old--and no longer relevant to real world practice. The bill 
we are introducing today would modernize and replace the current 
program so we can help raise the bar of quality in diagnosing cervical 
cancer. It would compliment the already extensive Federal quality 
control standards for Pap tests under CLIA.
  Without a doubt, regular Pap tests save women's lives. We need to 
make sure that the Federal Government's efforts to combat cervical 
cancer are the most effective they can be. This bill helps to do just 
that. I hope my colleagues will join me in supporting this women's 
health issue.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 2510

       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 ``Cytology Proficiency 
     Improvement Act of 2007''.

     SEC. 2. REVISED STANDARDS FOR QUALITY ASSURANCE IN SCREENING 
                   AND EVALUATION OF GYNECOLOGIC CYTOLOGY 
                   PREPARATIONS.

       (a) In General.--Section 353(f)(4)(B)(iv) of the Public 
     Health Service Act (42 U.S.C. 263a(f)(4)(B)(iv)) is amended 
     to read as follows:
       ``(iv) requirements that each clinical laboratory--

       ``(I) ensure that all individuals involved in screening and 
     interpreting cytological preparations at the laboratory 
     participate annually in a continuing medical education 
     program in gynecologic cytology that--

       ``(aa) is approved by the Accrediting Council for 
     Continuing Medical Education or the American Academy of 
     Continuing Medical Education; and
       ``(bb) provides each individual participating in the 
     program with gynecologic cytological preparations (in the 
     form of referenced glass slides or equivalent technologies) 
     designed to improve the locator, recognition, and 
     interpretive skills of the individual;

       ``(II) maintain a record of the cytology continuing medical 
     education program results for each individual involved in 
     screening and interpreting cytological preparations at the 
     laboratory;
       ``(III) provide that the laboratory director shall take 
     into account such results and other performance metrics in 
     reviewing the performance of individuals involved in 
     screening and interpreting cytological preparations at the 
     laboratory and, when necessary, identify needs for remedial 
     training or a corrective action plan to improve skills; and
       ``(IV) submit the continuing education program results for 
     each individual and, if appropriate, plans for corrective 
     action or remedial training in a timely manner to the 
     laboratory's accrediting organization for purposes of review 
     and on-going monitoring by the accrediting organization, 
     including reviews of the continuing medical education program 
     results during on-site inspections of the laboratory.''.

       (b) Effective Date and Implementation; Termination of 
     Current Program of Individual Proficiency Testing.--

[[Page S15921]]

       (1) Effective date and implementation.--Except as provided 
     in paragraph (2), the amendment made by subsection (a) 
     applies to gynecologic cytology services provided on or after 
     the first day of the calendar year beginning 1 year after the 
     date of the enactment of this Act, and the Secretary of 
     Health and Human Services (hereafter in this subsection 
     referred to as the ``Secretary'') shall issue final 
     regulations implementing such amendment not later than 270 
     days after such date of enactment.
       (2) Termination of current individual testing program.--The 
     Secretary shall terminate the individual proficiency testing 
     program established pursuant to section 353(f)(4)(B)(iv) of 
     the Public Health Service Act (42 U.S.C. 263a(f)(4)(B)(iv)), 
     as in effect on the day before the date of enactment of 
     subsection (a), at the end of the calendar year which 
     includes the date of enactment of the amendment made by 
     subsection (a).
                                 ______