Maryland CLIA and State Lab Requirements

Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states

What testing sites miss in Maryland

Since the COMAR 10.10 revision, every CLIA-waived test counts as an excepted test, replacing the old fixed list.
A letter-of-exception lab must still keep a procedure manual and run and record quality control on each day of testing, which CLIA alone does not require of waiver labs.
The licensee must notify OHCQ within 30 days of a change in ownership, name, location or director.

Does Maryland require a state lab license on top of CLIA?

Maryland requires a state license to perform lab tests in the state. A physician office lab or point-of-care lab (including a pharmacy or community health center) doing only CLIA-waived tests may get a letter of exception instead of a permit; any non-waived test, PPM procedures included, needs a permit. The laboratory director signs the application.

Letter of exception (waived tests); medical laboratory permit (all other tests)
Issued by Maryland Department of Health, Office of Health Care Quality
Reaches labs doing only waived tests

Citation: Md. Code, Health-Gen. 17-205; COMAR 10.10.03.01 to .04

Who is exempt in Maryland?

No office exemption: physician office labs and point-of-care labs get a letter of exception rather than no license. An employer whose trained operators run preliminary drug screens registers instead of obtaining a permit or letter.

Citation: COMAR 10.10.03.02; Md. Code, Health-Gen. 17-205(d)

How often does a Maryland lab registration renew?

Due A letter of exception or permit is valid for no more than two years and must be renewed before it expires

Do labs in other states need a Maryland license to test its specimens?

A license is required to test specimens from Maryland health care providers at a lab outside Maryland, or to represent a lab in Maryland wherever it is located.

Citation: Md. Code, Health-Gen. 17-205(a)(2), (3)

Does Maryland add a form to the CMS-116?

The OHCQ license application is separate from the CMS-116 and lists the tests, annual volume and the qualifications of the people who direct, supervise and perform testing.

Where does a Maryland CMS-116 go?

Maryland Department of Health, Office of Health Care Quality
Email: OHCQ.labs@maryland.gov
Phone: (410) 402-8025

Opening a testing site in Maryland?

We prepare the CMS-116 and any Maryland 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.