Clinical Laboratory Improvement Amendments of 1988

An analytically sensitive test always detects analytes when they are present in specimens. An analytically specific test does not detect analytes when they are absent. The Task Force also recommended that laboratories providing a test for routine clinical use (after it had been developed) demonstrate their ability to provide analytically valid tests. These laboratories are regulated under the Clinical Laboratories Improvement Amendments of 1988 (Holtzman, 2000). 

To order a copy of the Clinical Laboratory Improvement Amendments of 1988, refer to stock no. 069-001-00042-4 (price 4.50/copy) and mail request to Government Printing Office, PO Box 371954, Pittsburgh, PA 15250-7954. 202-783-3238. FAX 202-512-2250. 

Department of Health and Hnman Services, Health Care Financing Administration (1992) Clinical Laboratory Improvement Amendments of 1988 Final Rule. Federal Register 57,7001-7288. 

Regarding laboratory certification for private laboratories, the Clinical Laboratory Improvement Amendments (CLIA) state the conditions that all laboratories must meet to be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (57 FR 7139, Feb. 28,1992). The requirements do not apply to any... 

Rivers, P.A., A. Dobalian, and F.A. Germinario. 2005. A review and analysis of the clinical laboratory improvement amendment of 1988 Compliance plans and enforcement policies. Health Care Manage Rev. 30(2) 93-102. 

US Department of Health and Human Services. Medicare, Medicaid and CLIA programs regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Final rule. Federal Register 1992 57 7002-186. 

Peddecord KM, Hammond HC. Clinical laboratory regulation under the Clinical Laboratory Improvement Amendments of 1988 Can it be done Clin Chem 1990 36 2027-35. 

Current federal regulation of clinical laboratories is found within the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988) and implementing regulations.The law is quite comprehensive, but this wasn t always so. Prior to 1965, there was very little federal involvement in laboratory regulation. In fact, only a few states regulated or licensed medieal laboratories. Those states that did regulate laboratories did so mostly in conjunction with hospital licensing requirements. 

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