Maryland calls it a permit, not a license — but the effect is the same. Every lab performing testing in Maryland, and every out-of-state lab receiving specimens that originate in Maryland, needs a Maryland medical laboratory permit plus a CLIA certificate.

State agency

Maryland Department of Health, Office of Health Care Quality (OHCQ), Laboratory Licensing Programs — the office that issues medical laboratory permits and letters of permit exception.

License types

• Medical laboratory permit (general) — for labs performing non-waived testing; the application lists specialties and subspecialties by test category (chemistry, microbiology, hematology, pathology, and others).
• Excepted tests — all CLIA-waived tests are "excepted" under Maryland regulations and use a shorter schedule on the application.
• Letter of permit exception — for qualifying practitioners such as midwives and nurse practitioners.
• Out-of-state permit — required for any out-of-state laboratory that receives specimens originating in Maryland. Out-of-state providers that do not receive Maryland-originating specimens don't need one.

How to apply

Submit the State Compliance Application to OHCQ's Laboratory Licensing Programs (7120 Samuel Morse Drive, Second Floor, Columbia, MD 21046). Out-of-state applicants must also supply: a copy of their CLIA certificate, a copy of their home-state laboratory license if applicable, the most recent survey report with cited deficiencies and corrective actions, the laboratory director's state license to practice medicine from the state where the lab is located, and documentation that the director meets CLIA laboratory director qualifications.

Forms

Application forms

• State Compliance Application (PDF) — the Maryland permit application; mail with original signatures plus the CMS-116.
• Laboratory Licensing Change Form (PDF) — report ownership, director, location, and test-menu changes.
• Form CMS-116 — CLIA Application for Certification (PDF) — filed alongside the state application.
• Form CMS-209 — Laboratory Personnel Report (PDF) — keep current for surveyors.

Inspection preparedness — have these ready before the surveyors arrive:

• Form CMS-116 — CLIA Application for Certification (PDF) — surveyors verify the specialties, sites, and director on file match current operations.
• Form CMS-209 — Laboratory Personnel Report (PDF) — current personnel roster; surveyors require it up to date.
• ACC 212 — CLIA lab test menu — the lab's controlled test menu listing every test by specialty; surveyors cross-check it against the certificate.
• OHCQ does not publish a public inspection checklist; prepare against the CMS State Operations Manual, Appendix C (PDF) — federal survey procedures and interpretive guidelines.
• Generic CLIA Laboratory Test Menu & Methods form (PDF) — a blank, print-ready test menu any lab can use for inspection readiness; prepared by Zilgene.

Fees

There is no fee to apply for a Maryland laboratory license — CMS bills CLIA fees separately. After OHCQ receives a complete application with all requested information, expect 2–3 weeks to receive the Maryland laboratory license and CLIA certificate.

Personnel requirements

Maryland layers its permit on top of CLIA's personnel standards rather than running a separate personnel licensing system. The key Maryland-specific personnel point is the laboratory director: out-of-state applicants must document the director's state medical license and CLIA-qualifying training, education, and experience.

Inspection

OHCQ inspects and investigates licensed laboratories as it deems necessary under state law. Out-of-state applicants should expect their most recent survey history to be reviewed as part of the application.

Renewal and changes

Permits must be renewed on schedule; report changes to your laboratory (ownership, director, location, test menu) to OHCQ using the Department's laboratory licensing change process — unreported changes can disrupt your licensing status.

How Maryland differs from federal CLIA

• A Maryland medical laboratory permit is required in addition to the CLIA certificate.
• Out-of-state labs need the permit when they receive Maryland-originating specimens; the trigger is where the specimen comes from, not where the lab sits.
• Waived testing is handled through Maryland's "excepted tests" framework rather than a separate registration.
• No separate state personnel licensing system — Maryland leans on CLIA personnel standards, with director documentation reviewed at application.

Official links

• OHCQ State Compliance Application (PDF)
• OHCQ Laboratory Licensing Change Form (PDF)
• OHCQ Public Health Testing Application (PDF)

Last verified: October 2026