State Operations Manual (Pub. 100-07), Ch. 6 § 6006.6
Effective Dates
6006.6 – Effective Dates
(Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25)
The effective date of the initial Certificate for PPM procedures, Certificate of
Registration, or a Certificate of Waiver for new laboratories is the date the CLIA
application, Form CMS-116 (Exhibit 125) is entered into the CLIA Data System.
The effective date of the Certificate of Compliance is the date the laboratory is
surveyed and found in compliance with the CLIA requirements.
The effective date of the Certificate of Accreditation is the date the organization
verifies to CMS that the laboratory is accredited. This date can be no earlier than the
accreditation organization initial approval date. Once the effective dates are
established, the laboratory’s 2-year certificate cycle is set.