Sec. 10.10.03.05. Letter of Exception — Limited Testing for Rare Diseases

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.