Nevada Administrative Code › Chapter 652 - Medical Laboratories › OPERATION AND PERSONNEL › Section 652.320 - Inspections: Duties and authority of Division; submission of plan for correction of violations

Current through June 11, 2024
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. An authorized employee
			 or contractor of the Division may enter and inspect any building or premises to
			 secure compliance with or prevent a violation of any provision of this chapter
			 or chapter 652 of NRS.
3. 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.
4. The Division may request records from any
			 facility licensed pursuant to chapter 449 of NRS, including, without
			 limitation, any facility which is required by the regulations adopted by the
			 Board pursuant to NRS 449.0303  to be licensed, or any laboratory licensed
			 pursuant to chapter 652 of NRS that may have information pertinent to a
			 complaint which is within the authority of the Division to
			 investigate.
5. The Division shall
			 report violations noted at the time of each inspection by providing the
			 director, or the director's designee, with 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 submit the plan of correction to the Division, containing thereon the
			 plan of correction for each of the violations, within 14 days after receiving
			 the form. The plan must indicate the date by which each violation will be
			 corrected.
6. Failure to submit the
			 plan of correction timely pursuant to subsection 5 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; A
			 by
			 R149-15A,
			 eff. 6/21/2017; A by
			 R126-21A,
			 eff. 9/19/2022;	A by
				R126-21A,
				eff. 9/19/2022
NRS 439.200, 652.123  and
				  652.130