Rhode Island Code of Regulations
Title 216 - Department of health
Chapter 60 - Laboratories and Medical Examiner
Subchapter 05 - State Laboratory
Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis
Section 216-RICR-60-05-6.9 - Laboratory Governing Body, Management, and Personnel

Universal Citation: 216 RI Code of Rules 60 05 6.9

Current through September 18, 2024

6.9.1 Governing Body

A. Each laboratory must have a governing body or equivalent legal authority ultimately responsible for:
1. The management and control of the operation;

2. The assurance of the quality of services;

3. The compliance with all state and local laws and regulations; and

4. Compliance with other relevant health and safety requirements, including these Regulations.

6.9.2 Management

A. Each laboratory shall have a laboratory director who must be responsible for the day-to-day management and operation of the laboratory and to ensure the achievement and maintenance of quality standards of practice. The laboratory director must meet the following minimum qualifications:
1. Possess a doctorate in the chemical or biological sciences from a college or university accredited by a national or regional certifying authority and a minimum of two (2) years analytical laboratory experience, or possess a master's degree in the chemical or biological sciences and a minimum of four (4) years of analytical laboratory experience, or possess a bachelor's degree in the chemical or biological sciences and a minimum of five (5) years of analytical laboratory experience.

B. The director of each laboratory or his/her designee, must be responsible for the following:
1. To be present on the premises of the laboratory during the hours of operation to ensure adequate and appropriate supervision of laboratory activities;

2. To ensure the accurate performance of all tests in the laboratory including the submission of appropriate reports on all tests;

3. To ensure the supervision of all personnel in the laboratory and for hiring adequately trained personnel commensurate with the workload;

4. To be available during the hours of operation for personal or telephone consultation with personnel;

5. To notify RIDOH within thirty (30) days of any change in laboratory services or supervisory personnel;

6. To establish and adhere to written policies and procedures for a comprehensive quality assurance program; and

7. Such other activity as may be deemed appropriate.

C. The laboratory shall notify RIDOH within seven (7) days of any change in the laboratory director position. In the event the director of the laboratory is absent for a continuous period of thirty (30) days total (including the seven (7) days), the laboratory shall cease and desist operations on the thirtieth (30th) day unless a person who meets the qualifications of §6.9.2(A) of this Part is in attendance.

D. The laboratory director must designate a qualified quality assurance (QA) officer who is responsible for the laboratory's quality assurance plan and its implementation. This individual may be an outside consultant or the laboratory director.

E. The quality assurance officer must have earned at least a bachelor's degree in a chemical or biological science and two years of related laboratory experience.

The quality assurance officer qualifications may be met if the person has previous laboratory quality assurance experience acceptable to the RIDOH in a licensed, certified, or accredited laboratory, or possesses other qualifications acceptable to the RIDOH.

F. The quality assurance officer must be responsible for the oversight of Quality Control (QC) data, including establishing acceptance criteria and documenting/monitoring corrective action; where staffing allows, be independent of the technical areas for which he/she has QA oversight; have general knowledge of the methodologies for which data review is performed; have oversight of the laboratory's quality assurance system and conduct or arrange for annual internal audits of the technical operation and report findings to the laboratory director.

6.9.3 Personnel

A. Each laboratory must employ enough qualified personnel commensurate with the workload to ensure that services are provided effectively and safely and in accordance with prevailing laboratory standards and practices.

B. Each laboratory must establish a job description for each classification of position, clearly delineating qualifications, duties, and responsibilities inherent in each position.

C. Each laboratory must maintain personnel records for each employee which contain no less than current background and training documentation pertaining to qualifications; orientation procedures, including an initial demonstration of capability for each method and/or instrument the analyst will be performing and/or operating; evidence of periodic evaluation of work performance; and, such other training records as may be deemed appropriate.

D. Each laboratory must train personnel initially and annually thereafter on professional conduct, ethics, and state laws regarding cannabis.

E. Each laboratory must train personnel initially and annually thereafter on the use of the Cannabis Tracking System and any other tracking systems used by the laboratory.

Disclaimer: These regulations may not be the most recent version. Rhode Island 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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