Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations (CMS-R-26)

OMB 0938-0612

The ICRs referenced in 42 CFR part 493 outline the requirements necessary to determine an entities compliance with CLIA. CLIA requires laboratories that perform testing on human beings to meet performance requirements (quality standards) in order to be certified by HHS. HHS conducts inspections to determine a laboratory's compliance with the CLIA requirements. CLIA implements the certificate, laboratory standards, and inspection requirements.

The latest form for Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations (CMS-R-26) expires 2024-01-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
CMS-R-26-Supporting_Statement_ 1-10-24 clean.docx Supporting Statement A
Section 493.1359- 493.1489-1491
Section 493.1359- 493.1489-1491
Section 493.1278
Section 493.1269
Section 493.1274
Section 493.1263
Section 493.1262
Section 493.1261
Section 493.1256
Section 493.1255
Sections 493.1252 and 493.1254
Section 493.1251
Section 493.1242
Section 493.1299
Section 493.801 and 493.803 Instruction

All Historical Document Collections

202401-0938-001 Approved with change	Revision of a currently approved collection	2024-01-12
202008-0938-009	Revision of a currently approved collection	2020-08-14
201702-0938-020 Approved with change	Extension without change of a currently approved collection	2017-02-27
201401-0938-008 Approved without change	Extension without change of a currently approved collection	2014-01-09
201012-0938-016 Approved without change	Extension without change of a currently approved collection	2010-12-27
200706-0938-009 Approved with change	Extension without change of a currently approved collection	2007-06-29
200402-0938-007 Approved without change	Revision of a currently approved collection	2004-02-18
200104-0938-001 Approved without change	Extension without change of a currently approved collection	2001-04-02
199802-0938-009 Approved without change	Extension without change of a currently approved collection	1998-02-26
199411-0938-008 Approved without change	Reinstatement without change of a previously approved collection	1994-11-17
199205-0938-001 Approved without change	New collection (Request for a new OMB Control Number)	1992-05-04

OMB Details

Section 493.801 and 493.803

Federal Enterprise Architecture: Health - Health Care Services