Required on Medicare and Medicaid claims for any laboratory performing tests covered by the CLIA Act
Upon certification, each laboratory is assigned an individual and unique CLIA number. Each CLIA number consists of ten alphanumeric positions. The CLIA number must be on all claims for laboratory services, or the claim will be returned as un- process able. The CLIA number must be entered in block 23 of Form CMS-1500 or the applicable electronic field.
In United States, prior to operating a laboratory of medium or high complexity the laboratory most apply for a receive a CLIA number from Centers for Medicare and Medicaid Services (CMS).
Any change or addition of new methodologies used must be reported to CLIA/CMS.
The Laboratory Directory is responsible for the overall quality and function of the laboratory. The Laboratory Directory is required to take an initial 20 hours of medical education to become a laboratory directory.
The laboratory is inspected every 2 years by a CMS/CLIA designee. This is usually the Division of Facility Services for the state or by COLA which contracts with CMS to provide this service.
CLIA is an acronym for the law US "Clinical Laboratory Improvement Act" passed in 1988. It has been subsequently amended
| Loop | Seg ID | Segment Name | Format | Length | Ref# | Req | Value |
| 2300 | REF | CLIA Number | ID | 3 | R | REF | |
| Element Separator | AN | 1 | * | ||||
| REF01 | Reference Identification Qualifier | ID | 2/3 | 128 | R | X4 = Clinical Laboratory Improvement Amendment Number | |
| Element Separator | AN | 1 | * | ||||
| REF02 | Reference Identification | AN | 1/30 | 127 | R | Print the CLIA Number | |
| Segment Terminator | ~ |
Example
CLM*100068*22526.25***11:B:1*Y*A*Y*Y~
REF*X4*4325K442~
K3*This is sample for K3 Comments. This will be printed in EDI File~
HI*BK:I70211~
For complete Example, please refer to use case 11 in the Home page