I 
109TH CONGRESS 
1ST SESSION 
H. R. 686 
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 
FEBRUARY 9, 2005 
Mr. CUMMINGS (for himself and Mr. RUPPERSBERGER) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on Ways and Means, for a pe-
riod to be subsequently determined by the Speaker, in each case for con-
sideration of such provisions as fall within the jurisdiction of the com-
mittee 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 2005’’.
SEC. 2. PROTECTION OF EMPLOYEES OF PROVIDERS AND 
SUPPLIERS OF CLINICAL DIAGNOSTIC LAB-
ORATORY TESTS WHO REPORT VIOLATIONS. 
(a) IN GENERAL.—Section 1846 of the Social Secu-
rity Act (42 U.S.C. 1395w–2) is amended by adding at 
the end the following new subsection: 
‘‘(c)(1)(A) Each provider or clinical laboratory ap-
proved for participation under this title to provide clinical 
diagnostic laboratory tests shall post in a conspicuous 
place a notice to employees that indicates the manner in 
which to report instances of noncompliance with condi-
tions of participation under this title of the provider or 
laboratory (as the case may be), including deficiencies with 
respect to testing, quality, and inadequately trained per-
sonnel. 
‘‘(B)(i) A notice under subparagraph (A) shall in-
clude— 
‘‘(I) the name and contact information of the 
appropriate entity, accreditation organization, or 
State or Federal agency to report instances of non-
compliance; and 
‘‘(II) a description of the rights and protections 
under this section of individuals who report in-
stances of noncompliance. 
‘‘(ii) The Secretary shall specify the form of the no-
tice.
‘‘(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, 2006. 
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 by an investigative organization 
of a report of an instance of noncompliance with condi-
tions of participation by a provider or clinical laboratory 
approved for participation under this title to provide clin-
ical diagnostic laboratory tests, the investigative organiza-
tion 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 re-
port. 
‘‘(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) in advance 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 
report shall include information on reports made under 
subsection (c), actions taken under subsection (d), the 
promptness with which such actions were taken, the find-
ings of any investigation of such reports, and any actions 
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.’’.