Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.03 - Medical Laboratories - Licenses
Section 10.10.03.06 - Letter of Exception-Limited Testing for Rare Diseases Standards and Requirements

Universal Citation: MD Code Reg 10.10.03.06

Current through Register Vol. 51, No. 19, September 20, 2024

A. Application Requirements and Testing Approval. A person required to obtain a license to operate a laboratory that chooses to operate under a letter of exception-limited testing for rare diseases shall:

(1) Submit:
(a) A completed:
(i) Application as prescribed in Regulation .04 of this chapter; and

(ii) Report or questionnaire as required by the Secretary to determine regulatory compliance;

(b) A copy of the laboratory's:
(i) Current CLIA certificate issued by CMS; and

(ii) Most recent CLIA survey report;

(c) Documentation of the rare disease testing offered or performed, including but not limited to:
(i) The test procedure, including instructions for quality control and quality assurance;

(ii) A description of the disease or condition;

(iii) An explanation of the clinical validity of the test;

(iv) The performance characteristics of the test;

(v) The expected turnaround time for patient test results; and

(vi) Additional information necessary for determining eligibility and compliance with this subtitle; and

(2) Agree to:
(a) Make records and reports available to the Department as the Secretary may require;

(b) Notify the Department when a change to a licensee's rare disease testing procedure occurs for the purpose of the Department's determining whether the change is in compliance with this subtitle;

(c) Perform not more than 50 rare disease tests each year on specimens from Maryland patients; and

(d) Submit to the Department statistics that detail the number and types of rare disease tests performed each year on specimens from Maryland patients.

B. Standards. A person that wishes to obtain and maintain a letter of exception-limited testing for rare diseases shall:

(1) Comply with good laboratory practices that include:
(a) Following the manufacturer's instructions for instrument or test system operation and test performance;

(b) Having and following a written procedure manual describing the processes for performing tests and reporting patient test results;

(c) Performing applicable instrument calibration procedures at least once every 6 months;

(d) Performing and documenting quality control procedures using applicable levels of control materials each day of testing; and

(e) Performing and documenting that remedial action has been taken when problems or errors are identified; and

(2) Meet the requirements and standards in this subtitle applicable to a permitted laboratory including:
(a) Proficiency testing under COMAR 10.10.05;

(b) Quality assurance under COMAR 10.10.06;

(c) Personnel under COMAR 10.10.07;

(d) Sanctions under COMAR 10.10.08; and

(e) CLIA regulations incorporated by reference at COMAR 10.10.01.04B(3)-(5).

C. If the submitted application and explanatory documentation do not meet the requirements of this regulation or if the information submitted for the plan is insufficient to make a determination of compliance with this subtitle, a person may:

(1) Submit amendments to the application and explanatory documentation; or

(2) Apply for a permit in accordance with this subtitle.

D. The OHCQ may conduct on-site surveys of a laboratory operating under a letter of exception-limited testing for rare diseases to:

(1) Investigate a complaint; or

(2) Determine compliance with this subtitle.

E. If a licensee wishes to perform more than 50 rare disease tests per year, the licensee shall submit an application for and obtain a permit as required under this subtitle.

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.
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