D.C. Mun. Regs. tit. 22, r. 22-C6406

Current through Register Vol. 71, No. 52, December 27, 2024

Rule 22-C6406 - LABORATORY PERSONNEL QUALIFICATIONS AND DUTIES

6406.1

All testing laboratory personnel shall be registered with the Board.

6406.2

All testing laboratory personnel shall:

(a) Pass a criminal background check pursuant to §§5411 of this subtitle; and

(b) Sign an attestation stating that they do not have any conflicts of interest with any other registered medical marijuana facility or personnel.

6406.3

A testing laboratory shall be staffed with at least the following personnel who shall meet the following requirements and perform the following duties:

(a) Laboratory Director:

(1) Shall have earned a Doctor of Medicine degree (M.D.), Doctor of Osteopathic Medicine degree (D.O.), or doctorate degree in chemical, physical, biological or clinical laboratory sciences from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education, and have at least two (2) years of post-degree laboratory experience;

(2) Shall be responsible for the overall operation of the testing laboratory, including but not limited to:

(A) Ensuring that the testing laboratory achieves and maintains quality standards;

(B) Analytical operation;

(C) Quality of the results;

(D) Supervising all laboratory personnel;

(E) Recordkeeping;

(F) Reporting results and data; and

(G) Ensuring compliance with all regulatory requirements; and

(3) May also serve in any other personnel role;

(b) Technical Supervisor:

(1) Shall have earned at least:

(A) A master's degree in medical technology, clinical laboratory science, or chemical, physical or biological science from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education, and have at least two (2) years of post-degree training and experience in high-complexity testing; or

(B) A bachelor's degree in medical technology, clinical laboratory science, or chemical, physical or biological science from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education, and have at least four (4) years of post-degree training and experience in high-complexity testing;

(2) Shall be responsible for, including but not limited to:

(A) Supervising laboratory personnel (with the exception of The Laboratory Director);

(B) Ensuring appropriate testing methods are performed;

(C) Ensuring equipment is operational, clean, and certified;

(D) Verifying and ensuring the accuracy of test results; and

(E) Training and competency assessments of laboratory personnel; and

(3) May also serve in the roles of Quality Assurance Manager, Testing Personnel and Collection Specialist;

(c) Quality Assurance Manager:

(1) Shall have earned at least:

(A) A master's degree or bachelor's degree in clinical laboratory science, medical technology, or chemical, physical or biological science from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education, and have at least one (1) year of post-degree training and experience in high-complexity testing; or

(B) An associate's degree in medical laboratory technology from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education, and have at least two (2) years of post-degree training and experience in high-complexity testing;

(2) Shall be responsible for, but not limited to:

(A) Implementing standard operating procedures (SOPs) for the testing laboratory;

(B) Ensuring that SOPs are followed; and

(C) Conducting quality assurance assessments;

(3) May also serve in the roles of Testing Personnel and Collection Specialist, if he or she meets the qualifications;

(d) Testing Personnel:

(1) Shall have earned at least a master's degree or bachelor's degree in clinical laboratory science, medical technology, or chemical, physical or biological science from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education;

(2) Shall be responsible for testing medical marijuana samples as set forth in §§6409 of this subtitle, and providing accurate results; and

(3) May also serve in the role of the Collection Specialist.

(e) Collection Specialist:

(1) Shall have earned at least:

(A) A master's degree or bachelor's degree in clinical laboratory science, medical technology, or chemical, physical or biological science from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education; or

(B) An associate's degree in medical laboratory technology from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education;

(2) Shall be responsible for:

(A) The selection and collection of representative samples from cultivation centers;

(B) Maintaining chain of custody; and

(C) Ensuring aseptic sampling techniques are used; and

(3) Shall not serve in any other personnel role unless he or she meets the educational and training requirements for that role as set forth in this subtitle.

D.C. Mun. Regs. tit. 22, r. 22-C6406

Final Rulemaking published at 65 DCR 10217 (8/9/2019); amended by Final Rulemaking published at 71 DCR 2388 (3/8/2024)