Current through all regulations passed and filed through September 16, 2024
(A)
The submission of
an application that results in the issuance of a provisional license or
certificate of operation for a testing laboratory irrevocably gives the
department consent to conduct all inspections necessary to ensure compliance
with the testing laboratory's application, state law, Chapter 3796. of the
Revised Code and the rules promulgated under Chapter 3796. of the Revised Code.
The department may conduct the inspection independently, or may work with other
departments, state agencies, or local authorities, including the department of
agriculture, the department of industrial compliance and the state fire
marshal, to ensure compliance with the testing laboratory's application, state
law, Chapter 3796. of the Revised Code and the rules promulgated under Chapter
3796. of the Revised Code.
(B)
An inspector
conducting an inspection pursuant to this rule does not need to be accompanied
by a licensed employee during the inspection. During an inspection, the
inspector may:
(1)
Review and make copies of all records maintained in
accordance with rule
3796:4-2-07
of the Administrative Code;
(2)
Enter any room in
the facility;
(3)
Inspect facility vehicles;
(4)
Review the
policies and procedures of the testing laboratory, including methods of
operating;
(5)
Survey the premises and any off-site
facilities;
(6)
Inspect all equipment, instruments, tools, materials,
machinery or any other resource used to analyze medical
marijuana;
(7)
Request access to locked areas in the facility;
and
(8)
Question licensed employees at the
location;
(C)
A pre-approval inspection of a testing laboratory that
is required before the department issues a certificate of operation to a
testing laboratory possessing a provisional license under rule
3796:4-1-06
of the Administrative Code shall occur at a mutually agreeable time. The
department shall rely on the facility's application, Chapter 3796. of the
Revised Code and the rules promulgated under Chapter 3796. of the Revised Code
to facilitate the inspection and ensure compliance of the facility. Upon the
completion of the pre-approval inspection, the department may issue:
(1)
A certificate of
operation in accordance with rule
3796:4-1-06
of the Administrative Code, at which point the facility will be permitted to
begin operations; or
(2)
A written statement listing the deficiencies identified
during the inspection that must be remedied before a certificate of operation
will be issued by the department.
(a)
Upon receipt of a statement of deficiencies, the
testing laboratory shall develop a plan of correction for each deficiency and
submit the plan in writing to the department for approval within ten business
days after receipt of the statement of deficiencies and request for a plan,
unless a written extension is issued by the department.
(b)
The plan of
correction must include specific requirements for corrective action that will
be performed within thirty calendar days after the department's acceptance of
the plan of correction, or the remaining time period under paragraph (B) of
rule
3796:4-1-06
of the Administrative Code, whichever is greater.
(c)
If the plan of
correction submitted is not acceptable to the department or would prevent the
facility from obtaining a certificate of operation in accordance with rule
3796:4-1-06
of the Administrative Code, the department may either direct the medical
marijuana licensee to resubmit a plan of correction or the department may
develop a directed plan of correction with which the testing laboratory must
comply. Upon acceptance of the written plan of correction, the department and
the testing laboratory will sign a mutually binding agreement defining the
terms under which the testing laboratory will be issued a certificate of
operation. If the parties are unable to come to terms on the written plan of
correction, the department may take any action permitted under rule
3796:5-6-01
of the Administrative Code.
(d)
The department
shall re-inspect a testing laboratory upon the completion of the written plan
of correction. If the corrective measures meet the department's satisfaction,
the department shall issue a certificate of operation. If the corrective
measures do not meet the requirements of the written plan of correction, the
department shall take action in accordance with rule
3796:5-6-01
of the Administrative Code.
(D)
The department
may, at any time it determines an inspection is needed, with or without notice,
conduct an inspection of a testing laboratory to ensure compliance with the
facility's application, state law, Chapter 3796. of the Revised Code and the
rules promulgated under Chapter 3796. of the Revised Code in accordance with
paragraph (A) of this rule. An inspection of a testing laboratory may include,
without limitation, investigation of standards for safety from fire on behalf
of the department by the local fire protection agency. If a local fire
protection agency is not available, the state fire marshal may conduct the
inspection after the medical marijuana testing laboratory pays the appropriate
fee to the state fire marshal for such inspection.
(E)
Following an
inspection conducted pursuant to paragraph (D) of this rule, the department
shall issue an inspection report that documents the following:
(1)
The observations
and findings of the inspection;
(2)
The outcome of
the inspection;
(3)
Any suggestions for the testing laboratory to take into
consideration; and
(4)
If applicable, a written statement listing the
deficiencies identified during the inspection.
(a)
Upon receipt of
a request for a written plan of correction, the testing laboratory shall
develop a plan of correction for each deficiency and submit the plan to the
department for approval within ten business days after receipt of the statement
of deficiencies, unless a written extension is issued by the
department.
(b)
The plan of correction must include specific
requirements for corrective action that will be performed within thirty
calendar days. If the plan submitted is not acceptable to the department, the
department may either direct the medical marijuana licensee to resubmit a plan
of correction or the department may develop a directed plan of correction with
which the testing laboratory must comply. Upon acceptance of the written plan
of correction, the department and the testing laboratory will sign a mutually
binding agreement defining the terms agreed upon by the parties. If the parties
are unable to come to terms on the written plan of correction, the department
may take any action permitted under rule
3796:5-6-01
of the Administrative Code.
(c)
The department
shall re-inspect a testing laboratory upon the completion of the written plan
of correction. If the corrective measures meet the department's satisfaction,
the department shall indicate such on the inspection report and conclude the
inspection. If the corrective measures do not meet the requirements of the
written plan of correction, the department shall take action in accordance with
rule
3796:5-6-01
of the Administrative Code.
(F)
If an inspector
finds evidence of operational failures or conditions that create a likelihood
of diversion, contamination, risk to public health or the occurrence of a
prohibited activities under rule
3796:5-6-02
of the Administrative Code, the department may take immediate action authorized
under rule
3796:5-6-01
of the Administrative Code.
(G)
To prevent
destruction of evidence, diversion or other threats to public safety, the
department may order an administrative hold of medical marijuana or medical
marijuana product or any books and records of any licensee. The department may
assess the costs of an investigation, including travel and the time of any and
all employees, to a licensee.
