[House Report 110-566]
[From the U.S. Government Publishing Office]



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:

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) 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 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.
    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.

                       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 laboratory 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 on-going 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 
        cytology services.--
                  (A) * * *
                  (B) Standards.--The standards established 
                under subparagraph (A) shall include--
                          (i) * * *

           *       *       *       *       *       *       *

                          [(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.

           *       *       *       *       *       *       *


                                  
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