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Clinical Laboratory Improvement Amendments of 1988:
What are trends in violations cited by CMS and in CMS Enforcement Policy?
Francesco Germinario and Patrick A. Rivers,
Arizona State University
Ann L. Abbott, University of South Florida
Intensive media coverage of poor clinical laboratory practices in the 1980s
contributed to the passage of the Clinical Laboratory Improvement Amendments
(CLIA) in 1988. Laboratories regulated under CLIA are inspected, at least
biennially, by the Center for Medicare and Medicaid (CMS) services or its
delegate, to certify that they meet CLIA requirements. CLIA set standards for
laboratory personnel, quality control, and quality assurance based on test
complexity. Findings of violations may affect eligibility of the lab to
participate in Medicare and Medicaid. In addition, the Office of Inspector
General (OIG) of the Department of Health and Human Services (DHHS) is mandated
by law to protect the integrity of the HHS programs and impose sanctions on
clinical laboratories for fraud and abuse occurring in DHHS programs.
CMS is required to maintain the Laboratory Registry (LR), a yearly
publication that consists of a list of laboratories that generally hold a CLIA
certificate and have had sanctions imposed on them for the calendar year
preceding the date the information is made available. These laboratories are
identified through inspections by CMS investigators or state inspectors,
through private accreditation agencies and by the OIG. This paper looks at the
LRs from 1993 to 2001 and categorizes violations as high-rated or low-rated and
uses CMSs categorizations of sanctions as high-rated or low-rated to describe
the enforcement record under CLIA and trends in the types of violations and
sanctions recorded. The data indicated an increasing use of more lenient
sanctions from 1997-2001while there was an increase in the number of high-rated
violations listed.
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