Retention of CLIA Certification Records

6138 - Retention of CLIA Certification Records (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Essential data from all CLIA forms can be captured electronically in the CMS mainframe data system, and will maintain the data for 7 years following the year in which the record is created, pursuant to Subpart R of the Federal Acquisition Regulations (incorporated by reference in Article XII.A of the Section 1864 agreement). The Section 1864 agreement and Subpart R do not preclude limiting data captured to “essential” elements. For example, the deficiency codes and correction dates from the Form CMS-2567 are essential, but the narrative description of deficiencies or corrections are not. Article XII.A of the Section 1864 agreement requires retention of survey and certification records for three years following the year in which the record is created. This provision permits retention of the records in electronic form. Additional expectations are found in the CMS Records Schedule, which provides record descriptions and mandatory disposition instructions for the retention, transfer, retirement or destruction of Agency records as approved by the National Archives & Records Administration. See Section XI for specific CLIA-related information. However, where State law requires retention of records for a longer period or in specific formats, only the state actor is bound by the State law. The following sections specify record retention requirements for different compliance situations.