[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3512 Introduced in Senate (IS)]
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116th CONGRESS
2d Session
S. 3512
To clarify the authority for regulating laboratory-developed testing
procedures.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 17, 2020
Mr. Paul introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To clarify the authority for regulating laboratory-developed testing
procedures.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Verified Innovative Testing in
American Laboratories Act of 2020'' or the ``VITAL Act of 2020''.
SEC. 2. LABORATORY-DEVELOPED TESTING PROCEDURES.
(a) Findings.--Congress finds the following:
(1) Laboratory testing services are an integral part of
medical decision making, health management, and public health
surveillance.
(2) Provision of laboratory services is a professional
health care activity, which is regulated under the Public
Health Service Act (42 U.S.C. 201 et seq.).
(3) As witnessed with the 2020 COVID-19 pandemic, undue
regulation of laboratory-developed testing procedures may
hamper the medical management and public health response to
infectious disease outbreaks and pandemics, leading to delays
in access to testing and the ability to meet needed capacity to
stem community spread.
(b) Sense of Congress.--It is the sense of Congress that--
(1) the Federal Government should work to--
(A) ensure that patients receive the most
appropriate tests and procedures for medical
evaluations or treatment of clinical conditions;
(B) ensure that laboratory-developed testing
procedures are accurate, precise, clinically-relevant,
and monitored for continued quality performance;
(C) enable laboratory professionals to provide
professional services without undue restrictions;
(D) ensure that regulatory oversight of laboratory
tests does not limit patient access, impede innovation,
constrain flexibility or adaptability, or limit a
test's sustainability as a result of being unduly
burdensome or beyond the fiscal capacity of the
laboratory to reasonably validate and perform, or the
health care system to financially support;
(E) preserve the ability of the laboratory
community to provide surge capacity in public health
emergencies, including biological, chemical,
radiological, and nuclear threats, infectious disease
outbreaks, or other emergent situations; and
(F) safeguard, strengthen, and expand the existing
Laboratory Response Network, including public health
laboratories, sentinel laboratories, national
laboratories, commercial reference laboratories,
academic medical center laboratories, and hospital-
based laboratories; and
(2) laboratories using laboratory-developed testing
procedures should adhere to personnel requirements required
under section 353 of the Public Health Service Act (42 U.S.C.
263a), including such requirements relating to qualified
professionals who direct and supervise laboratories and consult
on diagnosis, treatment, and management of patient care, and
render opinions to clients concerning diagnosis, treatment, and
management of patient care required under such section 353.
(c) Authority Over Laboratory-Developed Testing Procedures.--All
aspects of a laboratory-developed testing procedures shall be regulated
by the Secretary of Health and Human Services under section 353 of the
Public Health Service Act (42 U.S.C. 263a), and no aspects of
laboratory-developed testing procedures shall be regulated under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), including
during a public health emergency declared under section 319 of the
Public Health Service Act (42 U.S.C. 247d).
(d) Definition.--In this section, the term ``laboratory-developed
testing procedure'' means a professional medical service that utilizes
a laboratory examination in the context of clinical care or public
health services and that meets the standards for establishment of
performance specifications established by regulation under section
353(f) of the Public Health Service Act (42 U.S.C. 263a(f)) applicable
to--
(1) laboratory modifications of test systems approved,
cleared, or authorized by the Food and Drug Administration
under section 510(k), 513, 515, or 564 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c, 360e, 360bbb-
3);
(2) methods developed or performed, and results produced
and interpreted, within a laboratory or laboratories under
common ownership or within the same organization, certified as
required under section 353(c) of the Public Health Service Act
(42 U.S.C. 263a(c));
(3) standardized methods such as those that are available
in textbooks and peer-reviewed publications; or
(4) methods in which performance specifications are not
provided by the manufacturer of test systems or components.
(e) Public Meeting.--Not later than 90 days after the date of
enactment of this Act, the Administrator of the Centers for Medicare &
Medicaid Services shall hold a public meeting to solicit
recommendations on updating the regulations under section 353 of the
Public Health Service Act (42 U.S.C. 263a).
(f) Report to Congress.--Not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human Services shall
report to the Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of the House of
Representatives, the following:
(1) Recommendations to update section 353 of the Public
Health Service Act (42 U.S.C. 263a) and the regulations
promulgated under such section, taking into consideration input
and recommendations from the Clinical Laboratory Improvement
Advisory Committee, to reflect the current state of the field
of clinical laboratory testing.
(2) An assessment of the availability and utilization of
laboratory-developed testing procedures during the 2020 COVID-
19 pandemic response that includes--
(A) validation criteria and process, and average
length of time from validation to achieving emergency
use authorization under section 564 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3)
before, and after, February 29, 2020;
(B) the number of patients and samples tested by
laboratories using such testing procedures; and
(C) recommendations to ensure that during future
infectious disease outbreaks, the public health system
and clinical laboratories do not encounter delays to
testing.
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