II 110th CONGRESS 1st Session S. 2510 IN THE SENATE OF THE UNITED STATES December 18, 2007 Ms. Landrieu (for herself and Mr. Isakson) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 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.

1.

Short title

This Act may be cited as the Cytology Proficiency Improvement Act of 2007.

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

(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).