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Union Calendar No. 348 

110TH CONGRESS 

2D SESSION H. R. 1237 

[Report No. 110–566] 

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. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 28, 2007 

Mr. GORDON of Tennessee (for himself, Mr. PRICE of Georgia, Ms. FOXX, Ms. 

HERSETH, and Mr. DEAL of Georgia) introduced the following bill; which 

was referred to the Committee on Energy and Commerce 

APRIL 8, 2008 

Additional sponsors: Mr. ROGERS of Michigan, Mr. BURGESS, Mr. COHEN, 

Mr. ENGLISH of Pennsylvania, Mr. JEFFERSON, Mr. BOUCHER, Mrs. 

MYRICK, Mr. GENE GREEN of Texas, Mr. HOLDEN, Ms. HOOLEY, Mr. 

BURTON of Indiana, Mr. SHUSTER, Mr. HINOJOSA, Mr. MCNULTY, Mr. 

SHIMKUS, Mr. WELDON of Florida, Mr. BOUSTANY, Mr. GONZALEZ, Mr. 

BOSWELL, Mr. SULLIVAN, Ms. BALDWIN, Mr. DOYLE, Mr. LATHAM, Mr. 

RYAN of Wisconsin, Mr. BONNER, Mr. NEAL of Massachusetts, Mrs. 

CUBIN, Mr. COBLE, Mr. PAUL, Mr. TIM MURPHY of Pennsylvania, Mr. 

PITTS, Mr. YOUNG of Alaska, Mr. DAVID DAVIS of Tennessee, Mrs. 

MALONEY of New York, Mr. ROTHMAN, Mr. SIRES, Mr. GINGREY, Mrs. 

MCCARTHY of New York, Mr. PICKERING, Mr. WYNN, Mr. MCGOVERN, 

Ms. ROYBAL-ALLARD, Mr. WEINER, Mrs. BLACKBURN, Mr. SNYDER, Ms. 

DEGETTE, Mr. MORAN of Virginia, Ms. ESHOO, Mr. BUTTERFIELD, Mrs. 

CAPPS, Mr. CARNAHAN, Mr. HARE, Mrs. BONO MACK, Mr. RENZI, Mr. 

ABERCROMBIE, Mr. PLATTS, Mr. ALLEN, Mr. HILL, Mr. ROSS, Ms. HARMAN, Mr. BUYER, Mr. RAMSTAD, Ms. WOOLSEY, Mr. DONNELLY, Mr. 

KILDEE, Mr. HALL of Texas, Mr. HIGGINS, Mr. LINCOLN DIAZ-BALART

of Florida, Ms. SLAUGHTER, Mr. BAIRD, Mr. FERGUSON, Mrs. WILSON

of New Mexico, Mr. MANZULLO, Mr. BRALEY of Iowa, Mr. ENGEL, Mr. 

BERRY, Mr. BOOZMAN, Mr. WOLF, Mr. PAYNE, Mr. FORTUN ̃O, Mr. 

DAVIS of Illinois, Mr. TERRY, Mr. KIND, Mr. MELANCON, Mrs. JO ANN

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NOLDS, Mr. ALTMIRE, Mr. HINCHEY, Mr. KENNEDY, Mr. LEVIN, Ms. 

SCHAKOWSKY, Mr. RADANOVICH, Mr. BILIRAKIS, Mr. FOSSELLA, Mr. 

MARKEY, Mr. LEWIS of Georgia, Mr. TIBERI, Mr. BARROW, Mr. 

PASCRELL, Mr. CASTLE, Mr. UPTON, Ms. SOLIS, Mr. ISSA, Ms. KAPTUR, 

Mr. HALL of New York, Mr. WHITFIELD of Kentucky, Mr. MEEK of 

Florida, Mr. LANGEVIN, Mr. INSLEE, Mr. WAXMAN, Mr. MATHESON, Mr. 

THOMPSON of Mississippi, Mr. SENSENBRENNER, Mr. KING of New 

York, Mr. COURTNEY, Ms. BERKLEY, Mr. PETRI, Mr. LARSON of Connecticut, Mr. SCOTT of Georgia, Ms. SCHWARTZ, Mr. KIRK, Mr. UDALL

of New Mexico, Mr. TOWNS, Mr. CAMP of Michigan, Mrs. BOYDA of Kansas, Mr. STUPAK, Ms. GINNY BROWN-WAITE of Florida, Mr. BERMAN, 

Ms. ZOE LOFGREN of California, Mr. WALDEN of Oregon, Mr. BISHOP

of Georgia, Mr. JOHNSON of Illinois, Mr. COSTELLO, Mr. CALVERT, Ms. 

RICHARDSON, Mr. STEARNS, Mr. OLVER, Mr. WALSH of New York, Mr. 

AL GREEN of Texas, Mrs. GILLIBRAND, Mr. LOBIONDO, Mr. KUHL of 

New York, Mr. BRADY of Pennsylvania, Mr. MCINTYRE, Mr. WELCH of 

Vermont, Mr. SHADEGG, Mr. BUCHANAN, Mrs. CHRISTENSEN, Mr. 

DENT, Ms. SUTTON, Mrs. JONES of Ohio, Mr. SHAYS, Mr. FATTAH, Ms. 

MOORE of Wisconsin, Ms. DELAURO, Mr. PORTER, Mr. MURPHY of Connecticut, Mr. SAM JOHNSON of Texas, Ms. CLARKE, Mr. LYNCH, Mr. 

RUSH, Mr. LATOURETTE, Mr. EHLERS, Ms. TSONGAS, Mr. HOEKSTRA, 

Mr. BOREN, Mr. FEENEY, and Ms. SHEA-PORTER

APRIL 8, 2008 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Cytology Proficiency 

5 Improvement Act of 2007’’. 


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1 SEC. 2. REVISED STANDARDS FOR QUALITY ASSURANCE IN 

2 SCREENING AND EVALUATION OF 

3 GYNECOLOGIC CYTOLOGY PREPARATIONS. 

4 (a) IN GENERAL.—Section 353(f)(4)(B)(iv) of the 

5 Public Health Service Act (42 U.S.C. 263a(f)(4)(B)(iv)) 

6 is amended to read as follows: 

7 ‘‘(iv) requirements that each clinical 

8 laboratory— 

9 ‘‘(I) ensure that all individuals 

10 involved in screening and interpreting 

11 cytological preparations at the labora12 tory participate annually in a con13 tinuing medical education program in 

14 gynecologic cytology that— 

15 ‘‘(aa) is approved by the Ac16 crediting Council for Continuing 

17 Medical Education or the Amer18 ican Academy of Continuing 

19 Medical Education, and 

20 ‘‘(bb) provides each indi21 vidual participating in the pro22 gram with gynecologic cytologic 

23 preparations (in the form of ref24 erenced glass slides or equivalent 

25 technologies) designed to improve 

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1 pretive skills of the individual, 

2 and 

3 ‘‘(II) maintain a record of the cy4 tology continuing medical education 

5 results of each individual involved in 

6 screening and interpreting cytological 

7 preparations at the laboratory,’’. 

8 (b) EFFECTIVE DATE AND IMPLEMENTATION; TER9 MINATION OF CURRENT PROGRAM OF INDIVIDUAL PRO10 FICIENCY TESTING.— 

11 (1) EFFECTIVE DATE AND IMPLEMENTATION.— 

12 Except as provided in paragraph (2), the amend13 ment made by subsection (a) applies to gynecologic 

14 cytology services provided on or after the date that 

15 is one year after the date of the enactment of this 

16 Act, and the Secretary of Health and Human Serv17 ices (hereafter in this subsection referred to as the 

18 ‘‘Secretary’’) shall issue final regulations imple19 menting such amendment not later than 270 days 

20 after such date of enactment. 

21 (2) TERMINATION OF CURRENT INDIVIDUAL

22 PROFICIENCY TESTING PROGRAM.—As of the date of 

23 the enactment of this Act, the Secretary shall termi24 nate the individual proficiency testing program es25 tablished pursuant to section 353(f)(4)(B)(iv) of the 


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1 Public Health Service Act (42 U.S.C. 

2 263a(f)(4)(B)(iv)), as in effect before the enactment 

3 of this section. 

4 SECTION 1. SHORT TITLE. 

5 This Act may be cited as the ‘‘Cytology Proficiency 

6 Improvement Act of 2008’’. 

7 SEC. 2. REVISED STANDARDS FOR QUALITY ASSURANCE IN 

8 SCREENING AND EVALUATION OF 

9 GYNECOLOGIC CYTOLOGY PREPARATIONS. 

10 (a) IN GENERAL.—Section 353(f)(4)(B)(iv) of the Pub11 lic Health Service Act (42 U.S.C. 263a(f)(4)(B)(iv)) is 

12 amended to read as follows: 

13 ‘‘(iv) requirements that each clinical 

14 laboratory— 

15 ‘‘(I) ensure that all individuals 

16 involved in screening and interpreting 

17 cytological preparations at the labora18 tory participate annually in a con19 tinuing medical education program in 

20 gynecologic cytology that— 

21 ‘‘(aa) is approved by the Ac22 crediting Council for Continuing 

23 Medical Education or the Amer24 ican Academy of Continuing Med25 ical Education; and 


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1 ‘‘(bb) provides each indi2 vidual participating in the pro3 gram with gynecologic cytological 

4 preparations (in the form of ref5 erenced glass slides or equivalent 

6 technologies) designed to improve 

7 the locator, recognition, and inter8 pretive skills of the individual; 

9 ‘‘(II) maintain a record of the cy10 tology continuing medical education 

11 program results for each individual in12 volved in screening and interpreting 

13 cytological preparations at the labora14 tory; 

15 ‘‘(III) provide that the laboratory 

16 director shall take into account such 

17 results and other performance metrics 

18 in reviewing the performance of indi19 viduals involved in screening and in20 terpreting cytological preparations at 

21 the laboratory and, when necessary, 

22 identify needs for remedial training or 

23 a corrective action plan to improve 

24 skills; and 


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1 ‘‘(IV) submit the continuing edu2 cation program results for each indi3 vidual and, if appropriate, plans for 

4 corrective action or remedial training 

5 in a timely manner to the laboratory’s 

6 accrediting organization for purposes 

7 of review and on-going monitoring by 

8 the accrediting organization, including 

9 reviews of the continuing medical edu10 cation program results during on-site 

11 inspections of the laboratory.’’. 

12 (b) EFFECTIVE DATE AND IMPLEMENTATION; TERMI13 NATION OF CURRENT PROGRAM OF INDIVIDUAL PRO14 FICIENCY TESTING.— 

15 (1) EFFECTIVE DATE AND IMPLEMENTATION.— 

16 Except as provided in paragraph (2), the amendment 

17 made by subsection (a) applies to gynecologic cytology 

18 services provided on or after the first day of the first 

19 calendar year beginning 1 year or more after the date 

20 of the enactment of this Act, and the Secretary of 

21 Health and Human Services (hereafter in this sub22 section referred to as the ‘‘Secretary’’) shall issue final 

23 regulations implementing such amendment not later 

24 than 270 days after such date of enactment. 


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1 (2) TERMINATION OF CURRENT INDIVIDUAL

2 TESTING PROGRAM.—The Secretary of Health and 

3 Human Services shall terminate the individual pro4 ficiency testing program established pursuant to sec5 tion 353(f)(4)(B)(iv) of the Public Health Service Act 

6 (42 U.S.C. 263a(f)(4)(B)(iv)), as in effect on the day 

7 before the date of the enactment of subsection (a), at 

8 the end of the calendar year which includes the date 

9 of enactment of the amendment made by subsection 

10 (a). 


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Union Calendar No. 348 

110TH CONGRESS 

2D SESSION H. R. 1237 

[Report No. 110

–566] 

A BILL 

To amend the Public Health Service Act to provide 

arations, and for other purposes. ing and evaluation of gynecologic cytology preprevised standards for quality assurance in screenAPRIL 8, 2008 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


hsrobinson on PROD1PC76 with BILLS