NAC445A.5428. Inspection of laboratory by Bureau.

     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)