CLIA Certificate Status Changes

6014 - CLIA Certificate Status Changes (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Certificate of Waiver or Certificate for PPM Laboratories operating under a CoW or Certificate for PPM procedures must notify HHS or its designee prior to performing and reporting results for any test not covered under their certificate. To become certified to conduct the additional testing, the laboratory must submit a new CLIA application (Form CMS-116). For specific instructions on the application process, see section 6006. A fee coupon will be system generated once the data is entered into the CLIA Data System. The certificate is issued once the appropriate fees are paid. Certificate of Compliance to Certificate for PPM or Certificate of Waiver A laboratory operating under a Certificate of Compliance that is no longer performing nonwaived testing (excluding PPM procedures), may request to change to either a CoW or a certificate for PPM procedures. The laboratory must submit a new CLIA application (Form CMS-116). For specific instructions on the application process, see section 6006. However, the laboratory is not required to change its certificate. The laboratory may decide to retain its current certificate and change the type of certificate upon its certificate expiration. If the laboratory elects to change the certificate, the data must be updated in the CLIA Data System; therefore, a new certificate and fees will be system generated. The certificate will be issued after the fees are paid. Certificate of Accreditation to Certificate for PPM When a laboratory that operates under a CLIA Certificate of Accreditation decides to conduct PPM procedures ONLY, the laboratory may downgrade its Certificate to a CLIA Certificate for PPM procedures. The laboratory must submit a new CLIA application (Form CMS-116). For specific instructions on the application process, see section 6006. It may not continue to hold a Certificate of Accreditation. (The laboratory may continue voluntarily to be accredited by an AO. However, this accreditation would not be for CLIA purposes.) Certificate of Compliance to Certificate of Accreditation A laboratory requesting a change from a Certificate of Compliance to a Certificate of Accreditation must be in CLIA condition-level compliance. Once a credible AoC is received, and compliance is verified, the certificate change data may be entered into the CLIA Data System. A laboratory can elect to retain the Certificate of Compliance until the certificate expiration date and subsequently change the certificate status. If the laboratory elects to change its certificate status prior to the expiration date of the current CLIA certificate, the data system must be updated. The laboratory must submit a new CLIA application (Form CMS-116). For specific instructions on the application process, see section 6006. A new certificate will be generated once the data is entered into the data system; therefore, a Certificate of Registration and fees will be system generated. The Certificate of Registration will be issued once the appropriate fees are paid. The laboratory then continues the process for a Certificate of Accreditation. Certificate of Accreditation to Certificate of Compliance In order for a laboratory to request a change from a Certificate of Accreditation to a Certificate of Compliance, the laboratory must submit a new CLIA application (Form CMS-116) to the appropriate SA. For specific instructions on the application process, see section 6006. The CLIA system must be updated and a Certificate of Registration with appropriate fees will be system generated. The Certificate of Registration will be issued after the fees are paid. The laboratory then continues the process for a Certificate of Compliance.