[DOCID: f:hr566.110]
From the House Reports Online via GPO Access
[wais.access.gpo.gov]
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.
* * * * * * *
<all>