Sec. 10.10.03.01. General

A. Requirement.

(1) General. A person shall possess a license before:

(a) Offering to perform or performing a medical laboratory test or examination in this State;

(b) Offering to perform or performing a medical laboratory test or examination on a specimen acquired from a health care provider in this State at a laboratory located outside this State; or

(c) Representing or servicing in this State a laboratory regardless of the laboratory's location.

(2) Prohibited Tests. The Secretary may impose principal and alternative sanctions as set forth in COMAR 10.10.08.01A if a person offers to perform or performs a test or part of a test, including the use of a reagent, supply, procedure, technique, kit, or equipment, that:

(a) Does not produce accurate or reliable results as evidenced by documented, independent scientific testing and evaluation; or

(b) Lacks proof of efficacy substantiated by an independently conducted and documented scientifically based clinical trial.

(3) Cholesterol Testing Plan for Health Departments.

(a) A local or county health department intending to perform cholesterol testing outside a permanently located laboratory may submit to the Secretary a cholesterol testing plan instead of applying for a cholesterol testing permit.

(b) If the submitted plan meets applicable standards under this chapter, the Secretary may waive the permit requirement for a cholesterol testing permit.

(c) If the plan does not meet the applicable standards of this chapter, the local or county health department shall apply for a permit as set forth in this chapter.

B. Limitation. A person may not operate a laboratory in a discipline other than what is listed on the license.

C. Eligibility. A person meeting the requirements and standards of this chapter may apply for one or more of the following licenses:

License:	Laboratory that may apply for the license:
Letter of exception	POL POCL
Permit (single-site)	POL POCL State, county, or municipal hospital commercial
Permit (multi-site)	State, county, or municipal hospital private nonprofit mobile

D. Issuance.

(1) Provisional Permit.

(a) The Secretary may issue a provisional permit before or after conducting an initial survey and pending determination of compliance with the standards in this chapter.

(b) A provisional permit is valid for not more than 180 days and may not be renewed.

(2) Letter of Exception and Permit. The Secretary may issue a letter of exception or permit that:

(a) Is valid for not more than 2 years from the date of issue; and

(b) Shall be renewed before its date of expiration if a person intends to operate the laboratory in the succeeding permit period.

(3) Single-Site and Multi-Site Licenses.

(a) Except as set forth in §D(3)(b) of this regulation, a person shall obtain a separate, single-site license for each location at which a laboratory performs a test.

(b) The Secretary may issue a multi-site license to a person operating:

(i) A mobile laboratory using the address of its home base or main administrative office in the State;

(ii) A nonprofit laboratory or public health laboratory performing limited public health testing; and

(iii) Hospital laboratories located at the same street address or within contiguous buildings and under common direction.

E. In order to maintain a State license issued by the Department pursuant to this subtitle, a licensee shall be in compliance with all applicable federal, State, and local laboratory requirements.