108th Congress

Clinical Laboratory Compliance Improvement Act

H.R. 5311

Background

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (P.L. 100-578), which was signed into law on October 31, 1988, represents the legal foundation for regulatory oversight of laboratory testing performed in the United States. The Clinical Center established the CLIA Resource Center located in the Department of Laboratory Medicine to assist the National Institutes of Health (NIH) intramural laboratories in meeting the operational standards required by CLIA. Currently, there are about 50 NIH laboratories that are CLIA-certified.

In March 2004, the Baltimore Sun reported that invalid HIV and hepatitis test results were sent to hundreds of patients from June 2002 to August 2003. Congressional hearings were held, and former employees testified that they had complained about deficiencies in the laboratory processing the tests. As a result of media and congressional attention, Representative Elijah Cummings (D-MD) introduced H.R. 5311 with the goal of protecting whistleblowers and improving compliance and laboratory standards.

In fall 2004, the CLIA Resource Center provided posters to certified laboratories regarding procedures for reporting noncompliance.

Provisions of the Legislation/Impact on NIH

H.R. 5311 would have amended the Social Security Act to:

• Require CLIA laboratories to post a notice in a conspicuous location that outlines procedures for reporting noncompliance
• Provide whistleblower protections to those who file a compliant regarding noncompliance
• Require the investigative organization informed of the noncompliance to contact the Secretary of Health and Human Services (HHS) and other investigative organizations within 3 business days of receiving a report and conduct a prompt investigation if one is warranted. An investigative organization was defined as an accreditation organization, a State agency, or another entity responsible for surveys of such providers or clinical laboratories.
• Require that standard accreditation surveys be conducted without prior notice
• Require the Secretary of HHS to submit an annual report to Congress describing how the Centers for Medicare and Medicaid Services, private accrediting organizations, and State health agencies responded to reports of deficiencies during the preceding year

Status and Outlook

H.R. 5311 was introduced by Representative Cummings on October 8, 2004, and was jointly referred to the House Committees on Energy and Commerce and on Ways and Means. No further action occurred on this legislation during the 108th Congress.