Current through December 12, 2024
1. Unless a
laboratory satisfies the provisions of paragraph (c) of subsection 2 of NAC
445A.0665, the Division shall
conduct an inspection of the premises and operation of each certified
laboratory or laboratory for which an application for certification is
submitted pursuant to the provisions of NAC
445A.0632. An inspection
conducted pursuant to this section must be conducted in accordance with the
provisions of sections 3.4 to 3.7, inclusive, of the Standards. If a certified
laboratory conducts analyses of water, the laboratory must be inspected in
accordance with the manual adopted by reference pursuant to the provisions of
paragraph (e) of subsection 1 of NAC
445A.0612. A certified
laboratory shall analyze a quality control sample for each method of testing an
analyte for which it is certified:
(a) At
least once every 3 months; and
(b)
Each time a new calibration curve is generated.
2. The Division shall conduct an inspection
specified in subsection 1:
(a) Not less than
once every 2 years, if the laboratory is a certified laboratory; or
(b) If the laboratory submits an application
for certification pursuant to the provisions of NAC
445A.0632, not more than 30 days
after the Division determines that the laboratory has complied with the
provisions of paragraphs (a), (b) and (c) of subsection 3 of that
section.
3. The Division
may conduct an inspection of a laboratory more than once every 2 years pursuant
to this section if:
(a) The Division receives
a complaint concerning the quality of the laboratory from a member of the
general public or any public agency;
(b) The Division has reasonable cause to
believe the laboratory is engaging in fraudulent activity;
(c) The Division identifies deficiencies in
the operation of the laboratory after conducting an inspection of the
laboratory pursuant to this section;
(d) The laboratory notifies the Division
pursuant to NAC
445A.0652 of any changes
specified in that section; or
(e)
Any circumstance specified in section 3.3 of the Standards occurs.
4. An inspection conducted
pursuant to the provisions of this section may include, without limitation:
(a) Requiring the laboratory to conduct an
analysis of a proficiency test sample; and
(b) Photocopying, photographing or
videotaping:
(1) Any part of the laboratory
that is used for analyzing samples of water pursuant to the Federal
Act;
(2) Any equipment, activity,
environmental sample, records or results of any test relating to the analysis
of water pursuant to the Federal Act;
(3) Any data concerning the control of the
quality of any analysis conducted by the laboratory pursuant to the Federal
Act; or
(4) Any other information
required by the Division to ensure compliance with the provisions of NAC
445A.0552 to
445A.067, inclusive.
5. Except as otherwise
provided in this subsection, the Division shall announce each inspection
conducted pursuant to the provisions of this section. The Division may conduct
an unannounced inspection of a laboratory if the Division determines that such
an inspection is required to ensure compliance by the laboratory with the
provisions of NAC
445A.0552 to
445A.067, inclusive. In
determining whether to conduct an unannounced inspection, the Division shall
consider:
(a) The laboratory's record of
compliance with the provisions of NAC
445A.0552 to
445A.067, inclusive;
(b) The results of any proficiency test taken
by the laboratory;
(c) The
performance of any analyst or other employee of the laboratory in conducting an
analysis of an environmental sample pursuant to the provisions of NAC
445A.0552 to
445A.067, inclusive;
(d) Any complaints concerning the laboratory
that the Division has received from members of the general public or any public
agency; and
(e) The performance of
the laboratory in conducting analyses pursuant to the provisions of NAC
445A.0552 to
445A.067, inclusive.
6. If the Division conducts an
inspection of a laboratory pursuant to the provisions of this section, the
laboratory shall:
(a) Ensure that any record
or other information which relates to compliance by the laboratory with the
Federal Act or NAC
445A.0552 to
445A.067, inclusive, and which
is required by the Division to conduct the inspection is available for review,
including, without limitation:
(1) The quality
manual adopted pursuant to the provisions of NAC
445A.0636;
(2) Any information concerning the methods of
testing used by the laboratory;
(3)
Any data concerning the control of the quality of an analysis conducted by the
laboratory; and
(4) Any information
concerning any proficiency test taken by the laboratory; and
(b) Allow the Division to:
(1) Examine any records of the laboratory
concerning the operation or certification of the laboratory that relate to
compliance by the laboratory with the Federal Act or NAC
445A.0552 to
445A.067, inclusive;
(2) Observe the operation, facilities and
equipment of the laboratory that relate to compliance with the Federal Act or
NAC 445A.0552 to
445A.067, inclusive;
(3) Interview any employee of the laboratory
who performs duties relating to compliance by the laboratory with the Federal
Act or NAC
445A.0552 to
445A.067, inclusive;
and
(4) Engage in any activity
which is necessary and appropriate for determining compliance by the laboratory
with the Federal Act or NAC
445A.0552 to
445A.067, inclusive, and which
is required by the Division.
7. If the Division conducts an inspection of
a laboratory, it shall, within 30 days after it conducts the inspection,
provide to the laboratory a copy of the report of the inspection. The report
must include any deficiency the Division discovers during its inspection of the
laboratory. The laboratory shall prepare a plan to correct the deficiency
specified in the report. The plan must:
(a)
Be submitted to the Division not more than 30 days after the laboratory
receives the report from the Division;
(b) Be submitted on a form approved by the
Division; and
(c) Include, without
limitation:
(1) The signature of the person
who prepared the plan; and
(2) The
proposed date by which the laboratory will correct the deficiency.
8. If, after reviewing
the plan submitted pursuant to subsection 7, the Division determines that the
plan is insufficient to correct the deficiency, the Division shall notify the
laboratory of that fact in writing. Upon receipt of the written notice, the
laboratory shall, not more than 30 days after receiving the notice, submit a
revised plan to the Division. If, after reviewing the revised plan, the
Division determines that the revised plan is insufficient to correct the
deficiency, or if the Division conducts an inspection of the laboratory and
determines that the deficiency has not been corrected, the Division shall deny
the laboratory's application for certification or revoke its
certification.
Added to NAC by
Environmental Comm'n by R070-99, eff. 5-26-2000; A by R061-04,
10-7-2004
NRS 445A.425,
445A.428
