Clinical Laboratory Improvement Act (CLIA)
Legislative History
CLIA-67; Clinical Laboratory Improvement Act of 1967 [P.L. 90-174]:
To implement CLIA-67, section 5(a) Part F of title III of the Public Health Service (PHS) Act (42 U.S.C. 262-3) was amended by the changing the title to read: “Licensing -- Biological Products and Clinical Laboratories” and by adding section 353 (42 (U.S.C.) 263). Section 353 regulated any laboratory engaged in interstate commerce, that is, soliciting or accepting (directly or indirectly) any specimen for laboratory examination or other laboratory procedures and required CLIA-67 licensure. Laboratories were given a full, partial, or exempt CLIA-67 license, depending on the scope of laboratory testing. Regulations included Applicability; License - Application & Renewal; Quality Control; Personnel Standards; Proficiency Testing; Accreditation; General Provisions; and Sanctions.
Medicare/Medicaid; Independent and Hospital Laboratories;
Only independent and hospital laboratories seeking Medicare/Medicaid reimbursement were regulated under Title XVIII and Title XIX of the Social Security Act. Each facility type had their own regulations to follow.
Medicare/Medicaid/CLIA-67 Regulations: August 5, 1988- Proposed [March 14, 1990 - Final and Effective 09/01/90]:
In April 1986, a study [Final Report on Assessment of Clinical laboratory Regulations] on clinical laboratories recommended that HHS review the existing regulations to determine how to improve the assurance of quality laboratory testing and achieve program uniformity.
The August, 1988, proposal sought to recodify the regulations for these programs [Hospital Laboratories, Section 1861(e) of the Social Security Act (SSA); Independent Laboratories, 1861(s)(11) and 1861(s)(12) and (13) of the SSA; CLIA-67, 42 U.S.C. 263(a), Section 353 of the Public Health Service (PHS) Act, interstate commerce; Medicaid, Section 1902(a)(9)(C) of the SSA] into a new Part 493 in order to simplify administration and unify the health and safety requirements for all programs as much as possible.
In 2003, CMS revised the Interpretative Guidelines for Laboratories. This revision reorganized and clarified the previous guidelines into 3 new sections: Pre-Analytic, Analytic, and Post-Analytic. See www.cms.hhs.gov/clia for more information.
