Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Ohio
- A waived blood lead site in Ohio must take part in a proficiency testing program acceptable for nonwaived blood lead testing, even though federal CLIA sets no proficiency testing for waived tests.
- An approved lead lab must tell the Department within 5 business days each time its CLIA certificate is renewed or changed, and within 24 hours if it is revoked, suspended or limited.
Does Ohio require a state lab license on top of CLIA?
No general Ohio lab license was confirmed from a primary source. Ohio does require Department of Health approval for any lab analyzing blood for lead, including a site running a waived lead test under a Certificate of Waiver, and that site must enroll in proficiency testing.
- Clinical laboratory approval for blood lead analysis
- Issued by Ohio Department of Health
Citation: Ohio Adm. Code 3701-82-02
What does Ohio charge?
$300 application fee for blood lead clinical laboratory approval (as of October 2026).
Citation: Ohio Adm. Code 3701-82-02(K)
Where does a Ohio CMS-116 go?
- Ohio Department of Health, CLIA Laboratory Program
- Email: CLIA@odh.ohio.gov
- Phone: (614) 466-1451
Opening a testing site in Ohio?
We prepare the CMS-116 and any Ohio filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.