Department of Health and Human Services
CLIA REGULATION OF
UNESTABLISHED LABORATORY TESTS
OFFICE OF INSPECTOR GENERAL
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452 as
amended by Public Law 100-504, is to protect the integrity of the Department of Health and
Human Services programs as well as the health and welfare of beneficiaries served by them.
This statutory mission is carried out through a nationwide program of audits, investigations,
inspections, sanctions, and fraud alerts. The Inspector General informs the Secretary of program
and management problems and recommends legislative, regulatory, and operational approaches
to correct them.
Office of Evaluation and Inspections
The Office of Evaluation and Inspections (OEI) is one of several components of the Office of
Inspector General. It conducts short-term management and program evaluations (called
inspections) that focus on issues of concern to the Department, the Congress, and the public.
The inspection reports provide findings and recommendations on the efficiency, vulnerability,
and effectiveness of departmental programs.
OEI's Chicago Regional Office prepared this report under the direction of William Moran,
Regional Inspector General and Natalie Coen, Deputy Regional Inspector General. Principal
OEI staff included:
John Traczyk, Team Leader
Bambi Straw, Program Specialist
Susan Otter, Lead Analyst
Dennis Tharp, Analyst
To obtain copies of this report, please call the Chicago Regional Office at 312-353-4124.
Reports are also available on the World Wide Web at our home page address:
E X E C U T I V E S U M M A R Y
To examine how the Centers for Medicare and Medicaid Services (CMS) regulates
laboratories conducting Live Blood Cell Analysis and other unestablished laboratory
The CMS has become aware that an increasing number of laboratory sites are