Nev. Admin. Code § 652.155

Current through August 29, 2024
Section 652.155 - Applicability; exemptions from compliance
1. Except as otherwise provided in this section and section 3 and NRS 652.071, the provisions of this chapter:
(a) Apply to:
(1) A laboratory which is licensed pursuant to NRS 652.080 and which provides services to the public; and
(2) A nonexempt laboratory which is registered pursuant to NAC 652.175; and
(b) Do not apply to:
(1) An exempt laboratory which:
(I) Is licensed pursuant to chapter 652 of NRS; and
(II) Pays the applicable fees required by NAC 652.488;
(2) An HIV testing laboratory which:
(I) Is licensed pursuant to chapter 652 of NRS; and
(II) Pays the applicable fees required by NAC 652.488;
(3) A licensed laboratory only for the collection of specimens which:
(I) Is licensed pursuant to chapter 652 of NRS;
(II) Pays the applicable fees required by NAC 652.488;
(III) Has a director who possesses the qualifications prescribed by NAC 652.397; and
(IV) Complies with the requirements of section 3; or
(4) A laboratory which is registered as exempt pursuant to NAC 652.175.
2. Except as otherwise provided in subsection 3, a person who is employed by a laboratory that is licensed by or registered with the Division pursuant to chapter 652 of NRS may perform a test without complying with the provisions of this chapter if:
(a) The test has been classified as a waived test pursuant to 42 C.F.R. Part 493 , Subpart A; and
(b) The director, a designee of the director or a licensed physician at the laboratory at which the test is performed:
(1) Verifies that the person is competent to perform the test;
(2) Ensures that the test is performed in accordance with instructions of the manufacturer of the test; and
(3) Validates and verifies the manner in which the test is performed by using controls which ensure that the results of the test will be accurate and reliable.
3. Except as otherwise provided in subsection 4, the provisions of subsection 2 do not relieve a person who performs a test from the requirement to:
(a) Comply with the policies and procedures that the director of the laboratory at which the test is performed has established pursuant to NAC 652.280;
(b) Comply with the laboratory safety guidelines adopted by the laboratory pursuant to NAC 652.291; or
(c) Obtain certification pursuant to NAC 652.470 and pay the applicable fees as set forth in NAC 652.488.
4. An advanced practice registered nurse as defined in NRS 632.012 or a physician assistant as defined in NRS 630.015 who is employed by a laboratory that is licensed by or registered with the Division pursuant to chapter 652 of NRS and who has not received certification pursuant to NAC 652.470 may perform a test without complying with the provisions of this chapter if the test:
(a) Has been classified as a waived test pursuant to 42 C.F.R. Part 493 , Subpart A; or
(b) Is a provider-performed microscopy procedure categorized pursuant to 42 C.F.R. § 493.19.
5. Except as otherwise provided in this subsection, a person may perform a test for the detection of the human immunodeficiency virus that is classified as a waived test pursuant to 42 C.F.R. Part 493 , Subpart A, without complying with the provisions of this chapter if he or she complies with NRS 652.186. This subsection does not apply to a person who holds a license or certification issued pursuant to this chapter or a license or certification described in NRS 652.210.
6. A medical officer employed by the Armed Forces of the United States to provide clinical laboratory services who is not licensed or certified pursuant to this chapter may provide clinical laboratory services in a hospital as part of a training or educational program pursuant to an agreement entered into in accordance with the provisions of NRS 449.2455.
7. As used in this section, "licensed physician" includes:
(a) A physician licensed as a doctor of medicine pursuant to chapter 630 of NRS;
(b) A physician licensed as a doctor of osteopathic medicine pursuant to chapter 633 of NRS;
(c) A chiropractic physician licensed pursuant to chapter 634 of NRS; and
(d) A podiatric physician licensed pursuant to chapter 635 of NRS.

Nev. Admin. Code § 652.155

Added to NAC by Bd. of Health, eff. 1-4-88; A 10-22-93; R177-97, 1-30-98; R078-04, 8-5-2004; R176-07, 1-30-2008; 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, 652.125 and 652.130