Short title

This Act may be cited as the

Clinical Laboratory Compliance Improvement Act of 2005

Protection of employees of providers and suppliers of clinical diagnostic laboratory tests who report violations

(a)

In general

Section 1846 of the Social Security 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 approved 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 conditions 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 personnel. (B) (i)A notice under subparagraph (A) shall include— (I)the name and contact information of the appropriate entity, accreditation organization, or State or Federal agency to report instances of noncompliance; and (II)a description of the rights and protections under this section of individuals who report instances of noncompliance. (ii)The Secretary shall specify the form of the notice. (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 initiated 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 clinical 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, reimbursement 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 reasonable 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 retaliation 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 eligible; (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.

Requirement for unannounced surveys

(a)

In general

Section 1846 of the Social Security Act (42 U.S.C. 1395w–2), as amended by section 2(a), is further amended by adding at the end the following new subsections:

(d) (1)Upon receipt by an investigative organization of a report of an instance of noncompliance with conditions of participation by a provider 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 developed 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 organization under a contract entered into with the Secretary, the Secretary shall provide for appropriate adjustments to payments under the contract for failure to carry out the responsibilities of this subsection. (3)In this subsection, the term investigative organization means an accreditation organization, a State agency, or other entity responsible for surveys of such providers or clinical laboratories. (e) (1)Each provider or clinical laboratory approved for participation under this title to provide clinical diagnostic laboratory tests shall be subject to a standard survey, to be conducted without any prior notice to the provider 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 notified) 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 procedures 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 scheduling procedures and the conduct of the surveys themselves. (f)The Secretary shall submit to Congress an annual 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 findings 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.

. (c)

Effective date

The amendment made by subsection (a) shall take effect January 1, 2006.