I 
108TH CONGRESS 
2D SESSION 
H. R. 5311 
To amend title XVIII of the Social Security Act to provide whistleblower 
protection to employees of clinical laboratories who furnish services under 
the Medicare Program, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 8, 2004 
Mr. CUMMINGS introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committee on 
Ways and Means, for a period to be subsequently determined by the 
Speaker, in each case for consideration of such provisions as fall within 
the jurisdiction of the committee concerned 
A BILL 
To amend title XVIII of the Social Security Act to provide 
whistleblower protection to employees of clinical labora-
tories who furnish services under the Medicare Program, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Clinical Laboratory 
Compliance Improvement Act of 2004’’.
‘‘(2)(A) A provider or clinical laboratory approved for 
participation under this title to provide clinical diagnostic 
laboratory tests shall not discriminate or retaliate in any 
manner against any employee of the provider or laboratory 
(as the case may be) because that employee, or any other 
person, has presented a grievance or complaint, or has ini-
tiated or cooperated in any investigation or proceeding of 
any kind, relating to the clinical diagnostic laboratory 
tests performed by the provider or laboratory (as the case 
may be) or other requirements and prohibitions of this 
title. 
‘‘(B) An employee of a provider or clinical laboratory 
approved for participation under this title to provide clin-
ical diagnostic laboratory tests who has been discriminated 
or retaliated against in employment in violation of this 
subsection may initiate judicial action in a United States 
District Court and shall be entitled to reinstatement, reim-
bursement for lost wages and work benefits caused by the 
unlawful acts of the employing provider or laboratory (as 
the case may be). Prevailing employees are entitled to rea-
sonable attorney’s fees and costs associated with pursuing 
the judicial action. 
‘‘(C) No action may be brought under subparagraph 
(B) more than 2 years after the discrimination or retalia-
tion with respect to which the action is brought.
‘‘(D) For purposes of this paragraph— 
‘‘(i) an adverse employment action shall be 
treated as ‘retaliation or discrimination’; and 
‘‘(ii) an adverse employment action includes— 
‘‘(I) the failure to promote an individual or 
provide any other employment-related benefit 
for which the individual would otherwise be eli-
gible; 
‘‘(II) an adverse evaluation or decision 
made in relation to accreditation, certification, 
credentialing, or licensing of the individual; and 
‘‘(III) a personnel action that is adverse to 
the individual concerned.’’. 
(b) CLERICAL AMENDMENT.—The heading of such 
section is amended by adding at the end the following: 
‘‘; WHISTLEBLOWER PROTECTIONS’’. 
(c) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall take effect January 1, 2005. 
SEC. 3. REQUIREMENT FOR UNANNOUNCED SURVEYS. 
(a) IN GENERAL.—Section 1846 of the Social Secu-
rity Act (42 U.S.C. 1395w–2), as amended by section 
2(a), is further amended by adding at the end the fol-
lowing new subsections: 
‘‘(d)(1) Upon receipt of a report of an instance of 
noncompliance with conditions of participation by a pro-
vider or clinical laboratory approved for participation
under this title to provide clinical diagnostic laboratory 
tests, the investigative organization shall— 
‘‘(A) provide notice to the Secretary and other 
investigative organizations involved of receipt of the 
report within 3 business days of such receipt using 
a standard format and manner of transmission de-
veloped by the Secretary for such purpose; 
‘‘(B) promptly determine whether to investigate 
the report; and 
‘‘(C) if appropriate, promptly investigate the report. 
‘‘(2) In measuring performance of an investigative or-
ganization under a contract entered into with the Sec-
retary, the Secretary shall provide for appropriate adjust-
ments to payments under the contract for failure to carry 
out the responsibilities of this subsection. 
‘‘(3) In this subsection, the term ‘investigative orga-
nization’ means an accreditation organization, a State 
agency, or other entity responsible for surveys of such pro-
viders or clinical laboratories. 
‘‘(e)(1) Each provider or clinical laboratory approved 
for participation under this title to provide clinical diag-
nostic laboratory tests shall be subject to a standard sur-
vey, to be conducted without any prior notice to the pro-
vider or laboratory (as the case may be). Each survey shall
include verification of compliance with requirements under 
subsection (c). 
‘‘(2) Any individual who notifies (or causes to be noti-
fied) a provider or laboratory of the time or date on which 
such a survey is scheduled to be conducted is subject to 
a civil money penalty not to exceed $2,000. 
‘‘(3) The Secretary shall review each State’s proce-
dures for the scheduling and conduct of standard surveys 
to assure that the State has taken all reasonable steps 
to avoid giving notice of such a survey through the sched-
uling procedures and the conduct of the surveys them-
selves. 
‘‘(f) The Secretary shall submit to Congress an an-
nual report on the actions taken under this section. Each 
such report shall include information on reports made 
under subsection (c), actions taken under subsection (d), 
the promptness with which such actions were taken, the 
findings of any investigation of such reports, and any ac-
tions taken based upon such findings.’’. 
(b) CLERICAL AMENDMENT.—The heading of such 
section, as amended by section 2(b), is further amended 
by adding at the end the following: 
‘‘; UNANNOUNCED SURVEYS’’. 
(c) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall take effect January 1, 2005. 
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