Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.03 - Medical Laboratories - Licenses
Section 10.10.03.01 - General
Universal Citation: MD Code Reg 10.10.03.01
Current through Register Vol. 51, No. 19, September 20, 2024
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
10.10.08.01AA 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 | POLPOCL |
| Permit (single-site) | POLPOCLState, county, or municipal hospitalcommercial |
| Permit (multi-site) | State, county, or municipal hospitalprivate nonprofitmobile |
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.
Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
