State Operations Manual (Pub. 100-07), Ch. 6 § 6022
CLIA Data System
6022 - CLIA Data System
(Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25)
The CLIA Data System is a computerized system that maintains demographic and
CLIA user fee billing data on every laboratory that is certified to participate in the
CLIA program. The data system supports CLIA program operations, including the
entry and display of the CLIA application (Form CMS-116), the billing and
collection of laboratory user fees and the issuance of certificates.
Authorized users can query the CLIA Data System to review CLIA certificate data and
laboratory accounts data. A browse feature allows users to view certificate/laboratory
data and laboratory accounts data within the CLIA Data System. A specific record
from a list of available records or data for a specific laboratory within the data system
may be selected. Additional features (such as adding or updating information) are
available based upon the security authorization of the individual user.
Standard or user defined reports that provide general information are available through
the CLIA Data System reporting functions. Consult with your supervisor or CMS to
obtain specific instructions/training on how to use the CLIA Data System, or any of the
current available CLIA Data System Users’ Guide(s).
State Agency and CMS Roles and Relationships with other Federal
Agencies