The Certificate of Registration and the First Survey

A new lab cannot start life with a Certificate of Compliance or a Certificate of Accreditation, because both depend on an inspection that has not happened yet. CLIA solves this with the Certificate of Registration. CMS's Quick Start Guide (March 2026) describes it as "issued to temporarily allow the laboratory to conduct nonwaived (moderate and/or high complexity) tests until the laboratory is inspected and found to be in compliance with CLIA regulations." Under it, "a laboratory is also permitted to conduct waived tests."

Who receives one?

"Only laboratories applying for a Certificate of Compliance or a Certificate of Accreditation will receive a CoR," the Quick Start Guide says. The regulation lists two groups (42 CFR 493.45(a)):

• every lab initially performing moderate complexity (other than PPM) or high complexity testing; and
• every lab holding a Certificate of Waiver or PPM certificate that intends to add moderate or high complexity testing.

Labs performing only waived tests, PPM procedures or both "are not required to obtain a registration certificate." A lab already holding a Certificate of Compliance that moves to accreditation does not need one either (493.57).

What does the lab agree to when it registers?

HHS issues the registration certificate when the lab files a complete application and agrees to three conditions (493.45(b), 493.57(a)):

1. notify HHS within 30 days of any change in ownership, name, location, director or, for high complexity labs, technical supervisor;
2. "treat proficiency testing samples in the same manner as it treats patient specimens"; and
3. pay the registration fee, which is $123 as of October 2026.

The application goes in on a CMS-116 with all ten sections complete and the director's qualification documents attached. See the CMS-116, section by section.

How long does a Certificate of Registration last?

For the Compliance path, it is valid "for a period of no more than two years or until such time as an inspection to determine program compliance can be conducted, whichever is shorter" (493.45(e)(1)). It is "not renewable," but may be reissued if HHS has not determined compliance before it expires (493.45(e)(2)). For the Accreditation path, it is valid for no more than two years and may be reissued in limited cases (493.57(d)).

What happens on the Compliance path?

The lab must permit "an initial inspection to assess the laboratory's compliance with the requirements of this part before CMS issues a certificate of compliance," at any time during operating hours (493.1777(a)). The Quick Start Guide says registered labs "typically have an initial survey in the first year." Before the registration expires, the lab must pay the certificate fee, be inspected and "demonstrate compliance with the applicable requirements of this subpart and subparts H, J, K, M, and Q" (493.45(c)).

Inspectors may ask the lab to test samples, interview staff, observe every phase of testing and copy records, and records must be "accessible and retrievable within a reasonable time frame" (493.1773). Expect questions on the core nonwaived requirements:

• proficiency testing enrollment and results for each regulated specialty;
• method verification for each new test system;
• quality control records and corrective actions;
• personnel files showing the director, consultants and testing staff meet subpart M; and
• the procedure manual and competency assessments.

After a successful survey, the lab receives a certificate fee invoice and then the Certificate of Compliance. Its biennial compliance survey fee follows.

What happens on the Accreditation path?

The lab must provide proof of accreditation by an approved accreditation program "within 11 months of issuance of the registration certificate" (493.57(b)(1)). The CMS-116 states the same deadline: evidence of accreditation "or evidence of application for such accreditation within 11 months after receipt of your Certificate of Registration." Miss it, and "the laboratory must meet, or continue to meet, the requirements of § 493.49," the Compliance path (493.57(b)(2)). See the CLIA accreditation organizations.

What if the lab is not ready?

For failure to meet the requirements, HHS "will initiate suspension or revocation of a laboratory's registration certificate and will deny the laboratory's application for a certificate of compliance" and may impose alternative sanctions; Medicare and Medicaid payments can be suspended (493.45(d)). The lab gets a statement of the grounds and a chance to appeal, and keeps its registration certificate during a timely appeal unless conditions pose an imminent and serious risk (493.45(f), (g)). The practical lesson is to treat the registration period as preparation time, not a grace period.

Where does White Glove CLIA fit?

We prepare the registration application: the CMS-116 with Section VIII, the specialty volumes and the director's qualification documents, ready for the owner or director to sign. The Nonwaived Certificate Application Packet is $1,499 (pricing). The lab pays the CMS coupon on pay.gov. We do not build the quality system, handle proficiency testing samples or act as a director, so a lab moving into nonwaived testing should line those up first. For the bigger picture, read moving from a waiver to moderate complexity testing and Compliance or Accreditation?