Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.03 - Medical Laboratories - Licenses
Section 10.10.03.05 - Letter of Exception-Limited Testing for Rare Diseases
Universal Citation: MD Code Reg 10.10.03.05
Current through Register Vol. 51, No. 19, September 20, 2024
A. The Secretary may waive the permit requirements under this subtitle for a laboratory that offers to perform or performs a rare disease test if the laboratory:
(1) Meets the requirements of Regulations .05
and .06 of this chapter; and
(2)
Obtains and maintains a letter of exception-limited testing for rare
diseases.
B. Eligibility. A person operating a medical laboratory may be eligible for a letter of exception-limited testing for rare diseases if the laboratory:
(1) Is operated as:
(a) A not-for-profit entity; or
(b) Part of an accredited educational
institution;
(2)
Performs not more than a total of 50 tests per year for a specific rare disease
on specimens from Maryland patients;
(3) Offers to perform or performs only rare
disease tests as defined in COMAR
10.10.01.03B;
(4) Possesses a valid CLIA certificate for
the complexity of the testing performed;
(5) Does not possess a Maryland permit for
offering to perform or performing medical laboratory testing; and
(6) Meets the requirements for a laboratory
to operate under a letter of exception-limited testing for rare
diseases.
C. Research Laboratory. A research laboratory may obtain a letter of exception-limited testing for rare diseases if the laboratory meets the eligibility requirements of §B of this regulation.
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