NAC652.320. Inspections: Duties and authority of Division; submission of plan for correction of violations.

     1. Except as otherwise provided in this subsection, the Division shall inspect periodically the premises and operation of each laboratory, including, without limitation, the premises of an outpatient center of the laboratory, if any. A laboratory that is subject to inspection by an accrediting organization approved by the Centers for Medicare and Medicaid Services of the United States Department of Health and Human Services pursuant to 42 C.F.R. §§ 493.551 to 493.575, inclusive, is not required to be inspected periodically by the Division if the reports of the inspections are available to the Division.

     2. Upon receipt of a complaint against a laboratory or its personnel, except for a complaint concerning the cost of services, the Division may conduct an investigation into the premises, qualifications of personnel, methods of operation, policies, procedures and records of that laboratory or any other laboratory which may have information pertinent to the complaint.

     3. The Division shall report violations noted at the time of each inspection by forwarding to the director a statement of violations, which must include the severity level for the violation as determined by the Division, and a form for the director to submit a plan of correction. Any violation for which a severity level is not specified in the statement of violations is presumed to be a violation of severity level one. The director shall return the form to the Division, containing thereon the plan of correction for each of the violations, within 10 working days after receiving the form. The plan must indicate the date by which each violation will be corrected.

     4. Failure to submit the plan of correction timely pursuant to subsection 3 to the Division constitutes a separate violation subject to monetary penalties with a severity level rated at the same level as the highest violation identified on the statement of violations.

     [Bd. of Health, Medical Laboratories Reg. §§ 3.2-3.3, eff. 8-5-74]—(NAC A 10-17-86; 10-22-93; R135-99, 11-29-99; R078-04, 8-5-2004; R176-07, 1-30-2008; R104-13, 3-28-2014)