Michigan Clinical Laboratory Requirements

Michigan has no separate state clinical laboratory license or personnel licensure. The program in Michigan is the federal CLIA program, administered by the Department of Licensing and Regulatory Affairs (LARA), Bureau of Health Services, Laboratory Improvement Section. Check facility category and any specialized testing rules with the Michigan Department of Health and Human Services (MDHHS). One Michigan-specific wrinkle: ACC-212 is Michigan's own CLIA test-menu form — it is Michigan-specific and should never be presented as a national or universal form. Request the current version from the LARA Laboratory Improvement Section.

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. 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

Michigan Department of Licensing and Regulatory Affairs (LARA) — Laboratory Improvement Section (Bureau of Health Services), Lansing — Michigan's state agency for federal CLIA (CMS CLIA State Agency Contacts (PDF)):

• Address: P.O. Box 30838, 611 W. Ottawa Street, First Floor, Lansing, MI 48909
• Phone: (517) 241-2648 · Fax: (517) 763-0214
• Email: LARA-BSC-CLIA@michigan.gov
• Program web address as listed in CMS's contacts: www.michigan.gov/clia

Facility requirements

• Michigan has no separate clinical-laboratory license, permit, or registration; Michigan labs apply for and hold the federal CLIA certificate, with applications routing through LARA's CLIA office. Confirm facility category and specialty-specific rules with MDHHS.
• A CLIA certificate matched to your test complexity is required before you test — see below.
• ACC-212: Michigan uses its own state-specific CLIA test-menu form (ACC-212) alongside the federal CMS-116/CMS-209. It is a Michigan instrument only — never present it as a national form.

Facility-type notes: there is no Michigan-level licensure distinction between independent, hospital-based, and physician-office laboratories — all operate under federal CLIA, and the certificate type (Waiver, Provider-Performed Microscopy, Compliance, or Accreditation) follows the complexity of the testing performed, not the setting. Confirm facility category with MDHHS. CMS applications in Michigan route through LARA's CLIA office regardless of facility type.

What federal CLIA requires

• A CLIA certificate for the testing your lab performs — apply on Form CMS-116, CLIA Application for Certification (PDF); in Michigan, applications route through LARA's CLIA office.
• 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 current test menu — in Michigan, kept on the state's ACC-212 test-menu form.
• No state fee: CLIA fees are billed by the federal CLIA program, never by Michigan.

Personnel requirements

Michigan has no state-level personnel licensure — no technologist, technician, or director license. Personnel must meet the federal CLIA qualification rules for your test complexity. See Zilgene's personnel reference pages:

• Laboratory Director
• Technical Supervisor / Technical Consultant
• Clinical Consultant
• General Supervisor
• Testing Personnel
• Frequently Asked Lab Personnel Questions

Forms and references

• Form CMS-116 — CLIA Application for Certification (PDF) — your CLIA certificate application.
• ACC-212 — Michigan's state-specific CLIA test-menu form. No public download link is published; request the current version from the LARA Laboratory Improvement Section.
• Form CMS-209 — Laboratory Personnel Report (PDF) — keep your personnel roster current for surveyors.
• CMS State Operations Manual, Appendix C (PDF) — federal survey procedures and interpretive guidelines (current Appendix C, Rev. 233, issued 09-12-25).
• Zilgene FAQ — common CLIA and certification questions, answered.

Inspection preparedness

LARA surveyors (on behalf of CMS) 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 matches the certificate. In Michigan, surveyors cross-check the ACC-212 test-menu form against the certificate — keep ACC-212 current alongside your CMS-116 and CMS-209. Have all of these ready before the surveyors arrive.

How Michigan differs from federal CLIA

For a typical independent lab, federal CLIA certification is the compliance baseline, administered by LARA as the state's CLIA agent, and there is no separate Michigan lab-license rule. Check facility category and specialized testing rules with MDHHS. The one Michigan-specific instrument is the ACC-212 test-menu form — a state form, never a universal one.

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

• Michigan Department of Health and Human Services (MDHHS)
• CMS CLIA State Agency Contacts (PDF) — LARA Laboratory Improvement Section contact details

Last verified: October 2026