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 Committee 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 laboratories who furnish services under the Medicare Program, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Clinical Laboratory 

5 Compliance Improvement Act of 2004’’. 
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1 SEC. 2. PROTECTION OF EMPLOYEES OF PROVIDERS AND 

2 SUPPLIERS OF CLINICAL DIAGNOSTIC LAB3 ORATORY TESTS WHO REPORT VIOLATIONS. 

4 (a) IN GENERAL.—Section 1846 of the Social Secu5 rity Act (42 U.S.C. 1395w–2) is amended by adding at 

6 the end the following new subsection: 

7 ‘‘(c)(1)(A) Each provider or clinical laboratory ap8 proved for participation under this title to provide clinical 

9 diagnostic laboratory tests shall post in a conspicuous 

10 place a notice to employees that indicates the manner in 

11 which to report instances of noncompliance with condi12 tions of participation under this title of the provider or 

13 laboratory (as the case may be), including deficiencies with 

14 respect to testing, quality, and inadequately trained per15 sonnel. 

16 ‘‘(B)(i) A notice under subparagraph (A) shall in17 clude— 

18 ‘‘(I) the name and contact information of the 

19 appropriate entity, accreditation organization, or 

20 State or Federal agency to report instances of non21 compliance; and 

22 ‘‘(II) a description of the rights and protections 

23 under this section of individuals who report in24 stances of noncompliance. 

25 ‘‘(ii) The Secretary shall specify the form of the no26 tice. 
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1 ‘‘(2)(A) A provider or clinical laboratory approved for 

2 participation under this title to provide clinical diagnostic 

3 laboratory tests shall not discriminate or retaliate in any 

4 manner against any employee of the provider or laboratory 

5 (as the case may be) because that employee, or any other 

6 person, has presented a grievance or complaint, or has ini7 tiated or cooperated in any investigation or proceeding of 

8 any kind, relating to the clinical diagnostic laboratory 

9 tests performed by the provider or laboratory (as the case 

10 may be) or other requirements and prohibitions of this 

11 title. 

12 ‘‘(B) An employee of a provider or clinical laboratory 

13 approved for participation under this title to provide clin14 ical diagnostic laboratory tests who has been discriminated 

15 or retaliated against in employment in violation of this 

16 subsection may initiate judicial action in a United States 

17 District Court and shall be entitled to reinstatement, reim18 bursement for lost wages and work benefits caused by the 

19 unlawful acts of the employing provider or laboratory (as 

20 the case may be). Prevailing employees are entitled to rea21 sonable attorney’s fees and costs associated with pursuing 

22 the judicial action. 

23 ‘‘(C) No action may be brought under subparagraph 

24 (B) more than 2 years after the discrimination or retalia25 tion with respect to which the action is brought. 
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1 ‘‘(D) For purposes of this paragraph— 

2 ‘‘(i) an adverse employment action shall be 

3 treated as ‘retaliation or discrimination’; and 

4 ‘‘(ii) an adverse employment action includes— 

5 ‘‘(I) the failure to promote an individual or 

6 provide any other employment-related benefit 

7 for which the individual would otherwise be eli8 gible; 

9 ‘‘(II) an adverse evaluation or decision 

10 made in relation to accreditation, certification, 

11 credentialing, or licensing of the individual; and 

12 ‘‘(III) a personnel action that is adverse to 

13 the individual concerned.’’. 

14 (b) CLERICAL AMENDMENT.—The heading of such 

15 section is amended by adding at the end the following: 

16 ‘‘; WHISTLEBLOWER PROTECTIONS’’. 

17 (c) EFFECTIVE DATE.—The amendment made by 

18 subsection (a) shall take effect January 1, 2005. 

19 SEC. 3. REQUIREMENT FOR UNANNOUNCED SURVEYS. 

20 (a) IN GENERAL.—Section 1846 of the Social Secu21 rity Act (42 U.S.C. 1395w–2), as amended by section 

22 2(a), is further amended by adding at the end the fol23 lowing new subsections: 

24 ‘‘(d)(1) Upon receipt of a report of an instance of 

25 noncompliance with conditions of participation by a pro26 vider or clinical laboratory approved for participation 
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1 under this title to provide clinical diagnostic laboratory 

2 tests, the investigative organization shall— 

3 ‘‘(A) provide notice to the Secretary and other 

4 investigative organizations involved of receipt of the 

5 report within 3 business days of such receipt using 

6 a standard format and manner of transmission de7 veloped by the Secretary for such purpose; 

8 ‘‘(B) promptly determine whether to investigate 

9 the report; and 

10 ‘‘(C) if appropriate, promptly investigate the report. 

11 ‘‘(2) In measuring performance of an investigative or12 ganization under a contract entered into with the Sec13 retary, the Secretary shall provide for appropriate adjust14 ments to payments under the contract for failure to carry 

15 out the responsibilities of this subsection. 

16 ‘‘(3) In this subsection, the term ‘investigative orga17 nization’ means an accreditation organization, a State 

18 agency, or other entity responsible for surveys of such pro19 viders or clinical laboratories. 

20 ‘‘(e)(1) Each provider or clinical laboratory approved 

21 for participation under this title to provide clinical diag22 nostic laboratory tests shall be subject to a standard sur23 vey, to be conducted without any prior notice to the pro24 vider or laboratory (as the case may be). Each survey shall 
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1 include verification of compliance with requirements under 

2 subsection (c). 

3 ‘‘(2) Any individual who notifies (or causes to be noti4 fied) a provider or laboratory of the time or date on which 

5 such a survey is scheduled to be conducted is subject to 

6 a civil money penalty not to exceed $2,000. 

7 ‘‘(3) The Secretary shall review each State’s proce8 dures for the scheduling and conduct of standard surveys 

9 to assure that the State has taken all reasonable steps 

10 to avoid giving notice of such a survey through the sched11 uling procedures and the conduct of the surveys them12 selves. 

13 ‘‘(f) The Secretary shall submit to Congress an an14 nual report on the actions taken under this section. Each 

15 such report shall include information on reports made 

16 under subsection (c), actions taken under subsection (d), 

17 the promptness with which such actions were taken, the 

18 findings of any investigation of such reports, and any ac19 tions taken based upon such findings.’’. 

20 (b) CLERICAL AMENDMENT.—The heading of such 

21 section, as amended by section 2(b), is further amended 

22 by adding at the end the following: 

23 ‘‘; UNANNOUNCED SURVEYS’’. 

24 (c) EFFECTIVE DATE.—The amendment made by 

25 subsection (a) shall take effect January 1, 2005. 

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