Laboratory Improvement Amendments

The Centers for Medicare Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the United States through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 200,000 laboratory entities. The 

Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO), has the responsibility for implementing the CLIA Program. The objective of the CLIA is to ensure quality laboratory testing. Although all clinical laboratories should be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid responsibilities. 

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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... 

CDC (Centers for Disease Control and Prevention). 2004. CLIA Subpart R. Enforcement Procedures. Clinical Laboratory Improvement Amendments U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Atlanta, GA [online]. Available http //www.phppo.cdc.gov/clia/regs/subpart r.aspx. [accessed Jan. 18, 2006]. 

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. 

Improving the quality of the biomonitoring laboratories that analyze human samples for the purposes of diagnosis, prevention, treatment, or health assessment. These laboratories are regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 CFR 493 [2000]). However, the focus of this statute is mainstream clinical testing. For example, the 41-page CLIA tabulation of approved proficiency-test providers lists only one environmental chemical (blood lead) (CMS 2005). 

Centers for Medicare and Medicaid Services (CMS). 2007b. Clinical Laboratory Improvement Amendments (CLIA), Tests Granted Waived Status under CLIA. Available at www.cms.hhs.gov/CLIA/10 Categorization of Tests.asp accessed on May 2007. 

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. 

The qualifications of personnel are determined by regulatory agencies and by the availability of suitable staff. In the United States, the qualifications for director, technical supervisor, and medical technologists are provided in the Clinical Laboratory Improvement Amendments. ... 

Clinical Laboratory Improvement Amendments. http //www.cms.hhs.gov/ciia/ (accessed July 20, 2004). 

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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