Rhode Island Code of Regulations
Title 216 - Department of health
Chapter 60 - Laboratories and Medical Examiner
Subchapter 05 - State Laboratory
Part 5 - Certifying Analytical Laboratories
Section 216-RICR-60-05-5.5 - Organization, Management, and Personnel
Universal Citation: 216 RI Code of Rules 60 05 5.5
Current through September 18, 2024
5.5.1 Governing Body
A. Each
analytical laboratory shall 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 federal, state and
local laws and regulations; and
4.
compliance with other relevant health and safety requirements, including this
Part.
5.5.2 Management
A. Each analytical
laboratory shall have a laboratory director who shall 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 shall meet the following minimum qualifications:
1. be a person of good moral character;
and
2. has earned, from a college
or university accredited by a national or regional certifying authority; a
doctorate in the chemical or biological sciences and a minimum of two (2) years
analytical laboratory experience, or has earned a master's degree in the
chemical or biological sciences and has a minimum of four (4) years of
analytical laboratory experience, or has earned a bachelor's degree in the
chemical or biological sciences and has a minimum of five (5) years of
analytical laboratory experience.
B. Exempt from § 5.5.2(A)(2) of this
Part are directors of analytical laboratories that were in operation on October
25, 1987 and who meet all other qualifications set forth in this
Part.
C. Directors of laboratories
in municipal waste treatment facilities testing non-potable water for only
fecal coliforms, Biochemical Oxygen Demand and total suspended solids shall be
deemed to be qualified if they have earned an associate's degree in the
biological or chemical sciences and have a minimum of two (2) years of
laboratory experience; or they have earned a bachelor's degree in the chemical
or biological sciences and have a minimum of one (1) year of laboratory
experience.
D. The director of each
analytical laboratory or his/her designee, who meets the qualifications of
§ 5.5.2(A)(2) of this Part shall furthermore be responsible for no less
than the following:
1. to be present on the
premises of the laboratory during the hours of operation for a sufficient
period of time 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 pursuant to §
5.6 of this Part.
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 the
Department within ten (10) 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.
E. In the event the director of the
laboratory is absent for a continuous period longer than one-month duration,
the laboratory shall not operate unless a person who meets the qualifications
of § 5.5.2(A)(2) of this Part is in attendance.
F. The laboratory director shall designate a
quality assurance officer who has the responsibility for the laboratory's
quality assurance plan and its implementation. The laboratory director may be
the self-designated Quality Assurance Officer or a consultant may be designated
to serve as the Quality Assurance Officer.
1.
The quality assurance officer shall 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
Department in a licensed, certified or accredited laboratory, or possesses
other qualifications acceptable to the Department.
2. The quality assurance officer shall:
a. be responsible for the oversight of QC
data, including establishing acceptance criteria and documenting/monitoring
corrective action;
b. where
staffing allows, be independent of the technical areas for which he/she has QA
oversight;
c. have general
knowledge of the methodologies for which data review is performed;
d. 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.
5.5.3 Personnel
A. Each analytical
laboratory shall employ a sufficient number of 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. A job description for each classification
of position shall be established, clearly delineating qualifications, duties
and responsibilities inherent in each position.
C. Personnel records shall be maintained for
each employee which contain no less than:
1.
current background information pertaining to qualifications, to justify initial
and continued employment;
2.
orientation, including an initial demonstration of capability for each method
and/or instrument the analyst will be performing and/or operating;
3. evidence of periodic evaluation of work
performance; and
4. such other data
as may be deemed appropriate.
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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
