69–006 

110TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 2d Session 110–566 

CYTOLOGY PROFICIENCY IMPROVEMENT ACT OF 2008 

APRIL 8, 2008.—Committed to the Committee of the Whole House on the State of 

the Union and ordered to be printed 

Mr. DINGELL, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

[To accompany H.R. 1237] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 1237) 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, 

having considered the same, report favorably thereon with an 

amendment and recommend that the bill as amended do pass. 

CONTENTS 

Page 

Amendment .............................................................................................................. 1 

Purpose and Summary ............................................................................................ 2 

Background and Need for Legislation .................................................................... 2 

Hearings ................................................................................................................... 3 

Committee Consideration ........................................................................................ 3 

Committee Votes ...................................................................................................... 3 

Committee Oversight Findings ............................................................................... 3 

Statement of General Performance Goals and Objectives .................................... 3 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 4 

Earmarks and Tax and Tariff Benefits .................................................................. 4 

Committee Cost Estimate ....................................................................................... 4 

Congressional Budget Office Estimate ................................................................... 4 

Federal Mandates Statement ................................................................................. 6 

Advisory Committee Statement .............................................................................. 6 

Constitutional Authority Statement ...................................................................... 6 

Applicability to Legislative Branch ........................................................................ 6 

Section-by-Section Analysis of the Legislation ...................................................... 6 

Changes in Existing Law Made by the Bill, as Reported ..................................... 7 

AMENDMENT

The amendment is as follows: 

Strike all after the enacting clause and insert the following: 


yshivers on PRODPC75 with HEARING
2 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Cytology Proficiency Improvement Act of 2008’’. 

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.—

(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 first calendar year beginning 1 year 

or more 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 

of Health and Human Services 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 the enactment of subsection (a), at the end of the calendar year which includes the date of enactment of the amendment made by subsection (a). 

PURPOSE AND SUMMARY

The purpose of H.R. 1237, the ‘‘Cytology Proficiency Improvement Act of 2008’’, is 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. 

BACKGROUND AND NEED FOR LEGISLATION

The American Cancer Society estimates that approximately 

11,150 cases of invasive cervical cancer are diagnosed each year in 

the United States. Cervical cancer was once a leading cause of cancer death among American women. This trend is changing, however, in part due to the increased use of the Papanicolaou (Pap) 


yshivers on PRODPC75 with HEARING
3 

test—a screening procedure that can identify changes in the cervix 

before cancer develops and find cancer in its early and most curable stages. Currently, women who are diagnosed and treated in 

the early stages of developing cervical cancer have a 92 percent 

survival rate. 

In 2005, the Federal Government launched a program to begin 

proficiency testing of pathologists and other laboratory professionals who perform Pap tests. The program was designed, however, using regulations written in 1992 to implement the Clinical 

Laboratory Improvement Amendments of 1988 (CLIA). In the 13 

years between the regulation and the program’s start, significant 

advancements in the science and practice of Pap tests have been 

made. 

H.R. 1237 recognizes the deficiencies in the current program and 

would modernize the program’s approach so that diagnostic skills 

can be adequately assessed and improved through mandated educational testing that reflects complex and state-of-the-art practice. 

HEARINGS

There were no hearings held in connection to the bill reported by 

the Committee. 

COMMITTEE CONSIDERATION

On Tuesday, March 11, 2008, the Subcommittee on Health met 

in open markup session and favorably forwarded H.R. 1237, 

amended, to the full Committee for consideration, by a voice vote. 

On Thursday, March 13, 2008, the full Committee met in open 

markup session and ordered H.R. 1237 favorably reported to the 

House, as amended by the Subcommittee on Health, by a voice 

vote. No amendments were offered during full Committee consideration. 

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion 

to report legislation and amendments thereto. There were no 

record votes taken on amendments or in connection with ordering 

H.R. 1237 reported to the House. A motion by Mr. Dingell to order 

H.R. 1237 favorably reported to the House, as amended, was 

agreed to by a voice vote. 

COMMITTEE OVERSIGHT FINDINGS

Regarding clause 3(c)(1) of rule XIII of the Rules of the House 

of Representatives, the oversight findings of the Committee regarding H.R. 1237 are reflected in this report. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

The objective of H.R. 1237 is to amend the Public Health Service 

Act to require the Secretary of Health and Human Services (HHS) 

to revise national quality assurance standards to assure consistent 

performance by laboratories of valid and reliable cytology services, 

to include requirements that each clinical laboratory: (1) ensure 

that all individuals involved in screening and interpreting 


yshivers on PRODPC75 with HEARING
4 

cytological preparations participate annually in an approved continuing medical education (CME) program in gynecologic cytology 

that provides each participant with gynecologic cytological preparations designed to improve locator, recognition, and interpretive 

skills; (2) maintain a record of the cytology CME program results 

for each individual involved in screening and interpreting 

cytological preparations at the laboratory; (3) provide that the laboratory director shall take into account such results and other performance metrics in reviewing the performance of individuals and, 

when necessary, identify needs for remedial training or a corrective 

action plan to improve skills; and (4) submit the CME 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 

CME program results during on-site inspections of the laboratory. 

Lastly, H.R. 1237 requires the Secretary of HHS to terminate individual proficiency testing that was in effect before enactment of 

this Act. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

Regarding compliance with clause 3(c)(2) of rule XIII of the Rules 

of the House of Representatives, the Committee finds that H.R. 

1237 would result in no new or increased budget authority, entitlement authority, or tax expenditures or revenues. 

EARMARKS AND TAX AND TARIFF BENEFITS

Regarding compliance with clause 9 of rule XXI of the Rules of 

the House of Representatives, H.R. 1237 does not contain any congressional earmarks, limited tax benefits, or limited tariff benefits 

as defined in clause 9(d), 9(e), or 9(f) of rule XXI. 

COMMITTEE COST ESTIMATE

The Committee adopts as its own the cost estimate on H.R. 1237 

prepared by the Director of the Congressional Budget Office pursuant to section 402 of the Congressional Budget Act of 1974. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House 

of Representatives, the following is the cost estimate on H.R. 1237 

provided by the Congressional Budget Office pursuant to section 

402 of the Congressional Budget Act of 1974: 

MARCH 31, 2008. 

Hon. JOHN D. DINGELL, Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 1237, a bill to amend the 

Public Service Act to provide revised standards for quality assurance in screening and evaluation of gynecologic cytology preparations. 


yshivers on PRODPC75 with HEARING
5 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Lori Housman. 

Sincerely, 

ROBERT A. SUNSHINE

(For Peter R. Orszag, Director). 

Enclosure. 

H.R. 1237—A bill to amend the Public Service Act to provide revised standards for quality assurance in screening and evaluation of gynecologic cytology preparations 

H.R. 1237 would amend the Clinical Laboratory Improvement 

Act (CLIA) by requiring clinical laboratories to ensure that all individuals involved in screening and interpreting cytological preparations participate in annual continuing medical education programs 

in gynecologic cytology. The bill would repeal the current requirement for proficiency testing for laboratory personnel performing cytology laboratory tests. 

CLIA activities, which are administered by the Centers for Medicare & Medicaid Services (CMS), are funded though user fees, 

which cover 100 percent of the cost of implementing the program. 

This legislation would have a minor impact on CMS’s workload. 

However, because the CLIA program recovers 100 percent of its 

costs through fees (which are accounted for in the budget as offsetting collections), any change in its administrative costs would be 

offset by an equal change in the fees that CMS charges. Hence, 

CBO estimates that implementing H.R. 1237 would have no net 

budgetary effect. Enacting the legislation would not affect direct 

spending or revenues. 

The bill would require clinical laboratories, including laboratories 

of public and private hospitals, to comply with record-keeping and 

management standards for personnel performing cytology laboratory tests. That requirement would impose intergovernmental and 

private-sector mandates as defined in the Unfunded Mandates Reform Act (UMRA). CBO estimates, however, that the costs to laboratories would be small because compliance would probably involve minor adjustments to existing administrative procedures. 

The bill also would impose a private-sector mandate on individuals who screen and interpret cytological preparations by requiring 

them to participate in continuing medical education programs. 

CBO estimates that the costs of carrying out that mandate also 

would be small because only several thousand individuals would be 

subject to the education requirements and most of them are already enrolled in such programs. Thus, CBO estimates that the 

costs to governmental and private-sector entities of the mandates 

in the bill would be small and would not exceed the thresholds established in UMRA ($68 million for intergovernmental mandates 

and $136 million for private-sector mandates, in 2008 adjusted annually for inflation). 

The CBO staff contacts for this estimate are Lori Housman (for 

federal costs), Lisa Ramirez-Branum (for the state and local impact), and Patrick Bernhardt (for the private-sector impact). This 

estimate was approved by Keith J. Fontenot, Deputy Assistant Director for Health and Human Resources, Budget Analysis Division. 


yshivers on PRODPC75 with HEARING
6 

FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of Federal mandates regarding H.R. 1237 prepared by the Director of the Congressional Budget Office pursuant to section 423 of the Unfunded Mandates Reform Act. 

ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the 

Federal Advisory Committee Act would be created by H.R. 1237. 

CONSTITUTIONAL AUTHORITY STATEMENT

Pursuant to clause 3(d)(1) of rule XIII of the Rules of the House 

of Representatives, the Committee finds that the Constitutional authority for H.R. 1237 is provided in Article I, section 8, clause 3, 

which grants Congress the power to regulate commerce with foreign nations, among the several States, and with the Indian Tribes. 

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that H.R. 1237 does not relate to the terms 

and conditions of employment or access to public services or accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act of 1995. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title 

Section 1 establishes the short title of the Act as the ‘‘Cytology 

Proficiency Improvement Act of 2008’’. 

Section 2. Revised standards for quality assurance in screening and 

evaluation of gynecologic cytology preparations 

Section 2 of this legislation amends Section 353f(4)(B)(iv) of the 

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

Section 2 requires the Secretary of Health and Human Services 

to revise national quality assurance standards to assure consistent 

performance by laboratories of valid and reliable cytology services. 

This includes regulations requiring that each clinical laboratory ensure all individuals involved in screening and interpreting 

cytological preparations participate annually in an approved CME 

program in gynecologic cytology that provides each participant with 

gynecologic cytological preparations (in the form of referenced glass 

slides or equivalent technologies) designed to improve locator, recognition, and interpretive skills. These CME programs must be approved by the Accrediting Council for Continuing Medical Education or the American Academy of Continuing Medical Education. 

Section 2 requires that each clinical laboratory maintain a record 

of the cytology CME program results for each individual involved 

in screening and interpreting cytological preparations at the laboratory. Furthermore, H.R. 1237 requires 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 laboraVerDate Aug 31 2005 12:42 Apr 09, 2008 Jkt 069006 PO 00000 Frm 00006 Fmt 6659 Sfmt 6602 E:\HR\OC\HR566.XXX HR566

yshivers on PRODPC75 with HEARING
7 

tory and, when necessary, identify needs for remedial training or 

a corrective action plan to improve skills. 

Section 2 requires that each clinical laboratory director submit 

the CME program results for each individual and, if appropriate, 

plans for corrective action or remedial training in a timely to the 

laboratory’s accrediting organization for purposes of review and ongoing monitoring by the accrediting organization, including reviews 

of the CME program results during on-site inspections of the laboratory. 

Section 2 states that these new regulations shall be implemented 

on or after the first day of the first calendar year beginning 1 year 

or more after the date of enactment of this Act, and the Secretary 

of HHS shall issue final regulations not later than 270 days after 

such date of enactment. 

Section 2 states that the Secretary of HHS shall terminate the 

existing individual proficiency testing program at the end of the 

calendar year in which the Act was enacted. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, 

existing law in which no change is proposed is shown in roman): 

PUBLIC HEALTH SERVICE ACT 

* * * * * * * 

TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC 

HEALTH SERVICE 

* * * * * * * 

PART F—LICENSING—BIOLOGICAL PRODUCTS AND CLINICAL

LABORATORIES

* * * * * * * 

Subpart 2—Clinical Laboratories 

CERTIFICATION OF LABORATORIES

SEC. 353. (a) * * * 

* * * * * * * 

(f) STANDARDS.—

(1) * * * 

* * * * * * * 

(4) NATIONAL STANDARDS FOR QUALITY ASSURANCE IN CYTOL- OGY SERVICES.— (A) * * * 

(B) STANDARDS.—The standards established under subparagraph (A) shall include— (i) * * * 

* * * * * * * 


yshivers on PRODPC75 with HEARING
8 

ø(iv) periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytological preparations, including announced 

and unannounced on-site proficiency testing of such 

individuals, with such testing to take place, to the extent practicable, under normal working conditions,¿ 

(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. 

* * * * * * * 

Æ 


yshivers on PRODPC75 with HEARING