Current through December 12, 2024
1. The Bureau 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.54272. 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 drinking water, the laboratory must be
inspected in accordance with the manual specified in subsection 6 of NAC
445A.54254. A certified
laboratory shall analyze a control sample for each method of testing and
analyte for which it is certified:
(a) At
least once every 12 months; and
(b)
Each time a new calibration curve is generated.
2. The Bureau 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.54272, not more than 30
days after the Bureau determines that the laboratory has complied with the
provisions of paragraphs (a), (b) and (c) of subsection 3 of that
section.
3. The Bureau
may conduct an inspection of a laboratory more than once every 2 years pursuant
to this section if:
(a) The Bureau receives a
complaint concerning the quality of the laboratory from a member of the general
public or any public agency;
(b)
The Bureau has reasonable cause to believe the laboratory is engaging in
fraudulent activity;
(c) The Bureau
identifies deficiencies in the operation of the laboratory after conducting an
inspection of the laboratory pursuant to this section;
(d) The laboratory notifies the Bureau
pursuant to NAC
445A.5429 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 drinking water;
(2) Any equipment, activity, environmental
sample, records or results of any test relating to the analysis of regulated
samples of drinking water;
(3) Any
data concerning the control of the quality of any analysis relating to samples
of drinking water conducted by the laboratory; and
(4) Any other information required by the
Bureau to ensure compliance with the provisions of NAC
445A.542 to
445A.54296, inclusive.
5. Except as otherwise
provided in this subsection, the Bureau shall announce each inspection
conducted pursuant to the provisions of this section. The Bureau may conduct an
unannounced inspection of a laboratory if the Bureau determines that such an
inspection is required to ensure compliance by the laboratory with the
provisions of NAC
445A.542 to
445A.54296, inclusive. In
determining whether to conduct an unannounced inspection, the Bureau shall
consider:
(a) The laboratory's record of
compliance with the provisions of NAC
445A.542 to
445A.54296, 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.542 to
445A.54296, inclusive;
(d) Any complaints concerning the laboratory
that the Bureau 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.542 to
445A.54296, inclusive.
6. If the Bureau 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.542 to
445A.54296, inclusive, and which
is required by the Bureau to conduct the inspection is available for review,
including, without limitation:
(1) The quality
manual adopted pursuant to the provisions of NAC
445A.54278;
(2) Any information concerning the methods of
testing used by the laboratory;
(3)
Any data concerning the control of the quality of a regulated analysis
conducted by the laboratory; and
(4) Any information concerning any
proficiency test taken by the laboratory; and
(b) Allow the Bureau 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.542 to
445A.54296, inclusive;
(2) Observe the operation, facilities and
equipment of the laboratory that relate to compliance with the Federal Act or
NAC 445A.542 to
445A.54296, inclusive;
(3) Interview any employee of the laboratory
who performs duties relating to compliance by the laboratory with the Federal
Act or NAC
445A.542 to
445A.54296, 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.542 to
445A.54296, inclusive, and which
is required by the Bureau.
7. If the Bureau 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 Bureau 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 Bureau not more than 30 days after the laboratory receives
the report from the Bureau;
(b) Be
submitted on a form approved by the Bureau; 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 Bureau determines that the plan is
insufficient to correct the deficiency, the Bureau 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 Bureau. If, after reviewing the revised plan, the Bureau determines that
the revised plan is insufficient to correct the deficiency, or if the Bureau
conducts an inspection of the laboratory and determines that the deficiency has
not been corrected, the Bureau shall deny the laboratory's application for
certification or revoke its certification.
Added to NAC by Bd. of
Health by R203-99, eff. 8-1-2001
NRS 445A.860,
445A.863
