Georgia Clinical Laboratory Requirements

CLIA-only state. Georgia does not require a separate state clinical laboratory license: DCH's clinical-laboratory licensure update notice dated 7/1/2021 (HB 93) removed state licensure for clinical laboratories, collection stations, tissue banks, and laboratory directors, and suspended enforcement. The current DCH Healthcare Facility Regulation Division (HFRD) CLIA page shows a CLIA-only process. The owner accepted this verification over the screening matrix's "state-specific regulation" row on 2026-10-19. DCH HFRD also serves as Georgia's CLIA State Agency.

Scope of this guide

This guide addresses a typical independent commercial clinical laboratory testing human specimens; it is not a legal opinion or final facility-opening checklist. Facility licensure, personnel licensure, hospital/facility rules, out-of-state testing permits, payer enrollment, and specialty rules are separate questions — confirm each with the state authority. 'Needs state confirmation' means no definitive conclusion was established; it does not mean the state has no additional requirements. Before relying on this guide, verify with the state: ownership/facility type, testing complexity and specialties, whether specimens are collected or tested in-state, whether tests are sent out of state, and whether personnel licenses are required.

State agency

Georgia Department of Community Health (DCH), Healthcare Facility Regulation Division (HFRD), Diagnostic Services Unit — the State Agency for CLIA in Georgia (per Georgia DPH's CLIA page, which states: "The State Agency for CLIA in Georgia is the Georgia Department of Community Health, Healthcare Facility Regulation Division").

Facility requirements

No separate Georgia facility license. Georgia is CLIA-only: hold your federal CLIA certificate for the testing you perform. DCH's 7/1/2021 notice removed the former state licensure program for clinical laboratories, collection stations, and tissue banks. DCH's Healthcare Facility Regulation Division (HFRD) is Georgia's CLIA State Agency — submit Form CMS-116 through HFRD (DCH HFRD — CLIA).

By facility type

  • Independent clinical laboratories — federal CLIA certificate only; no Georgia facility permit required.
  • Hospital-based laboratories — the hospital itself is licensed by HFRD; the laboratory operates under the federal CLIA certificate, with no separate Georgia lab license.
  • Physician-office laboratories (POLs) — federal CLIA rules apply (Certificate of Waiver or PPM for limited testing); Georgia adds no state layer.
  • Collection stations — a collection station that performs no testing is not a "laboratory" under CLIA; Georgia's former collection-station licensure was removed in 2021.

What federal CLIA requires

  • A CLIA certificate for the testing your lab performs — apply on Form CMS-116, CLIA Application for Certification (PDF).
  • A laboratory director and qualified personnel for your test complexity — see Zilgene's personnel reference pages below.
  • Proficiency testing enrollment for regulated analytes, quality control and quality assessment programs, and a controlled test menu.

Personnel requirements

Federal CLIA personnel standards apply — no separate Georgia personnel licenses. DCH's 7/1/2021 notice removed state laboratory-director licensure along with facility licensure. Meet the CLIA personnel qualification requirements for your certificate type and test complexity; see Zilgene's personnel reference pages:

Forms and references

Inspection preparedness

Federal surveyors verify that the specialties, sites, and director on your CMS-116 match current operations, that your CMS-209 personnel roster is current, and that your test menu is controlled and matches the certificate. Have all three ready before the surveyors arrive. Keep a copy of the DCH 7/1/2021 licensure-update notice in your compliance file — it documents why Georgia requires no state license, useful if a payer or partner still asks for one.

How Georgia differs from federal CLIA

Georgia adds no state layer on top of federal CLIA. The practical Georgia-specific points: DCH's Healthcare Facility Regulation Division is the CLIA State Agency (submit CMS-116 through HFRD, not directly to CMS), and the 2021 repeal (HB 93) means older references to Georgia laboratory or laboratory-director licensure — including pre-2021 DCH licensure packets still floating around online — are obsolete. Keep a copy of the DCH 7/1/2021 licensure-update notice in your compliance file in case anyone still asks for a Georgia license.

How Zilgene can help

Zilgene guides laboratories through CLIA certification, personnel qualification, and inspection readiness nationwide. Contact us for a free first consultation — every engagement is scoped and quoted upfront.

Official links

Last verified: October 2026