Haw. Code R. § 11-850-136 - Enforcement; suspension and revocation of laboratory certification
(a) A certified laboratory or a laboratory
seeking certification shall provide the department access to inspect the
laboratory facility, interview laboratory personnel, or review, inspect,
evaluate, and audit records and documents related to the analyses of dispensary
licensee samples at any time to verify compliance with this
subchapter.
(b) If the department
finds that a certified laboratory is not in compliance with the requirements of
this chapter, the department shall notify the certified laboratory in writing
of the specific areas of non-compliance and the department may do one or more
of the following:
(1) Establish a specific
timeframe for the correction of areas of non-compliance;
(2) Require the certified laboratory to
submit, within fifteen days of receipt of the department's notification, a
written corrective action plan that addresses the areas of non-compliance and
that shall be subject to approval by the department; or
(3) Suspend a laboratory certification and
prohibit the laboratory from handling and analyzing cannabis and manufactured
cannabis products.
(c) If
a satisfactory corrective action plan is not submitted to the department within
the required timeframe or the identified areas of non-compliance are not
corrected to the satisfaction of the department within the required timeframe,
the department may suspend or revoke a laboratory certification.
(d) The department may summarily suspend a
laboratory certification if the department finds that a certified laboratory
has engaged in a deliberate and willful violation of this subchapter or that a
violation presents a substantial probability that physical harm will
result.
(e) The department may
suspend or revoke a laboratory certification for any of the following reasons:
(1) Violation of any provision of this
chapter;
(2) Failure to maintain a
current accreditation with an accreditation body whose standards are equivalent
to the ISO/IEC 17025;
(3)
Submission of misleading, incorrect, false, or fraudulent
information;
(4) Failure to allow
inspections by the department;
(5)
Failure to pass inspections by the department;
(6) Knowingly permitting unauthorized persons
to perform technical procedures or issue or sign reports;
(7) Consistent errors in performance of
laboratory procedures, based on faulty technique or controls;
(8) Where immediate action is required to
comply with the law or protect the health and safety of the general public;
or
(9) Any other reason consistent
with applicable laws, or other factors that may affect the health, safety, or
welfare of the public or a qualifying patient or qualifying out-of-state
patient.
(f) Except as
allowed by subsection (d), the department shall send, by certified mail return
receipt requested, written notification of suspension or revocation to the
laboratory and include the specific reasons for the department's action and the
process to request a reconsideration of the department's action pursuant to
section 11-850-137.
(g) Upon suspension of its certification, the
laboratory shall:
(1) Cease performing one or
more of the analyses allowed by the certification as directed by the
department;
(2) Follow all
conditions imposed on the certification by the department; and
(3) Take corrective action as required under
subsection (b).
(h) Upon
revocation of its certification, the laboratory shall:
(1) Surrender its certification to the
department;
(2) No longer accept or
analyze cannabis or manufactured cannabis products;
(3) Return to the dispensary or destroy in a
manner approved by the department any samples of cannabis or manufactured
cannabis products in its possession at the time of revocation.
(i) Notwithstanding a laboratory's
failure to surrender a revoked certification to the department, the laboratory
shall no longer be qualified to analyze cannabis or manufactured cannabis
products.
(j) A laboratory
aggrieved by a decision made pursuant to this section may request a
reconsideration of the action in accordance with section
11-850-137.
Notes
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