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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