Maryland's Letter of Exception for Waived Testing

Maryland licenses lab testing itself, not just labs above a certain complexity. Health-General Article § 17-205(a) says a person "shall hold a license issued by the Secretary" before offering or performing "medical laboratory tests or examinations in this State," before testing specimens from Maryland health care providers at a lab outside Maryland, and before representing or servicing a lab in Maryland "regardless of the laboratory's location." For waived testing, Maryland's answer is a lighter license: the letter of exception.

What is a letter of exception?

COMAR 10.10.01.03 defines it as "a license issued by the Secretary authorizing the operation of a laboratory to offer to perform or perform one or more excepted tests." It is still a license. The statute tells the Secretary to "issue a letter of exception to a laboratory that: (1) Performs only limited medical laboratory tests or examinations; and (2) Meets the exception requirements in regulations" (§ 17-205(b)).

Which tests qualify has changed. Maryland once kept its own short list. The current rules define an "Excepted test" as "a medical laboratory test that is a CLIA waived test" (COMAR 10.10.01.03), and COMAR 10.10.03.02B says a lab operating under a letter of exception "may perform one or more CLIA waived tests." Guides that list a handful of Maryland-approved tests are describing the old system.

Which labs can hold one?

Two kinds of labs, and a director who qualifies:

• A physician office laboratory (POL): "a medical laboratory operated by a single practice of medicine, individually or collectively by one or more physicians, that is used solely as an adjunct to the care of patients of the practice."
• A point-of-care laboratory (POCL): "a laboratory operated as part of, or in association with, a medical care facility, such as a hospital, nursing home, community health center, health maintenance organization, county or municipal health department, or a pharmacy."

The individual directing the lab must either qualify as a lab director under 42 CFR 493.1405 (for example, a physician licensed in Maryland with appropriate laboratory training or experience), or show training in performing and interpreting excepted tests and hold a Maryland license in one of the professions COMAR 10.10.03.02A lists, which include nurse practitioners, nurse midwives, physician assistants, podiatrists and pharmacists. Certain substance use treatment program clinical staff also qualify.

One exclusion: "A person operating a temporary medical laboratory to perform health awareness tests, regardless of testing site location, is not eligible for a letter of exception" (COMAR 10.10.03.02A(3)). Health fairs and screening events take a different license. Employers running preliminary drug screens with trained operators register with the Department instead of obtaining a permit or letter (§ 17-205(d)).

Beyond CLIA, what must the lab do?

More than CLIA asks of a waiver lab. COMAR 10.10.03.02D requires "good laboratory practices that include":

1. following the manufacturer's instructions for instrument or test system operation and test performance;
2. "Having a procedure manual describing the processes for performing tests and reporting patient test results";
3. "Performing and documenting quality control procedures using applicable levels of control materials each day of testing";
4. documenting remedial action when problems or errors are found;
5. documenting lot numbers of all quality control reagents; and
6. documenting test system function for instruments with internal quality controls on each day of testing.

Daily controls are the big one. Under federal CLIA, a waiver lab's quality control is whatever the manufacturer's instructions call for. In Maryland, the letter of exception adds documented controls on every testing day. A practice running a few rapid strep tests a week needs a control routine and a log before the first patient. Our post on a waiver lab's compliance binder describes the records.

Labs running waived whole-blood lead tests also have state reporting rules: results go to the Maryland Department of the Environment in its approved format with the demographic details COMAR 10.10.03.02C lists.

How do you apply, and who signs?

Through the Office of Health Care Quality (OHCQ), which is also Maryland's CLIA State Agency. CMS's State Agency list (updated May 2026) gives OHCQ.labs@maryland.gov and (410) 402-8025. Under COMAR 10.10.03.04, a person applies "for a license for each laboratory location" on OHCQ's forms and describes the tests, the annual volume (excluding quality control and proficiency testing), and the qualifications of the people who direct, supervise and perform testing. "The laboratory director shall sign the application forms attesting that the information provided is accurate and that the laboratory is or will be operated in accordance with the requirements."

The state application is separate from the CMS-116. A new site files both, and the lab pays the federal fee to CMS from its emailed coupon: $248 every two years for a Certificate of Waiver, as of October 2026.

How long does it last, and what changes need notice?

• Two years at most. A letter of exception or permit is "valid for not more than 2 years from the date of issue" and "Shall be renewed before its date of expiration if a person intends to operate the laboratory in the succeeding permit period" (COMAR 10.10.03.01D(2)).
• One per site. Each location needs its own license, except mobile labs (licensed at their home base or main administrative office in Maryland), nonprofit or public health labs doing limited public health testing, and hospital labs at one address or in contiguous buildings under common direction (COMAR 10.10.03.01D(3)).
• Thirty-day notices. "A licensee shall notify the OHCQ within 30 days of a change in laboratory: (1) Ownership; (2) Name; (3) Location; or (4) Director" (COMAR 10.10.03.04D).
• No transfers. "A license is not transferable between laboratories, directors, or locations" (COMAR 10.10.03.04F).

Adding a PPM procedure or any nonwaived test takes the lab out of the letter of exception. Those tests need a full permit.

Does a lab in another state need Maryland approval?

Yes, if it tests specimens from Maryland health care providers. Section 17-205(a)(2) covers tests "on specimens acquired from health care providers in this State at a medical laboratory located outside this State." See testing specimens from other states.

What do we prepare for Maryland sites?

We prepare the CMS-116 and the OHCQ application for each location, confirm the director qualifies for a letter of exception, and build the test list from each kit's instructions. Your director reviews and signs both. Our State Lab Registration service is $299 per state on top of the $399 Certificate of Waiver Application, and the $549 Waiver Application with Compliance Binder adds the procedure manual and daily QC logs Maryland expects. Any state fee is paid by your organization to the state. The Maryland requirements page keeps the OHCQ details current.