Nevada Administrative Code Chapter 652 - Medical Laboratories
Here’s an overview of the Nevada Administrative Code – Chapter 652: Medical Laboratories, which governs the licensing, operation, personnel, testing standards, and inspections for medical labs in Nevada.
📋 1. Scope & Definitions
§652.Sec. 1 (effective Oct 23, 2024): Requires labs to inform the Division of Public and Behavioral Health in advance of any changes—such as new tests, analytes, lab name, or testing methods—then undergo an inspection to check compliance with Chapter 652 (law.cornell.edu).
Classifies license types, including fully licensed labs, specimen-collection-only labs, exempt laboratories, and physician-operated labs (law.cornell.edu).
🏛 2. Licensing, Registration & Permitting
Initial & renewal applications must be submitted in the approved Division form, followed by facility inspection (leg.state.nv.us).
Physician-operated labs can be exempt (only waived tests on own patients) or nonexempt, with different fee and registration requirements (leg.state.nv.us).
Temporary lab permits (e.g., at special events) last up to 90 days .
👩🔬 3. Laboratory Personnel
Details roles, qualifications, and required certifications for:
Directors (licensed physicians, doctoral-level scientists, technologists) (leg.state.nv.us)
General supervisors, technologists, histotechnologists, technicians, and point-of-care analysts (law.cornell.edu)
Sets rules on temporary certifications and experience for trainees/new hires (leg.state.nv.us).
🧪 4. Testing Standards & Quality Control
Prescribes use of waived, moderate, or high-complexity tests defined by federal CLIA rules (42 C.F.R. Pt 493) (leg.state.nv.us).
Moderate/high complexity point-of-care testing is allowed only by qualified staff under proper training .
Emphasizes validation and instrument verification as part of compliance inspections (law.cornell.edu).
🔍 5. Inspections, Reporting & Compliance
Division conducts inspections upon license issuance/renewal or when a lab reports changes (law.cornell.edu).
Reports, proficiency testing, personnel training, lab safety protocols, access and accessioning documentation are mandatory (law.cornell.edu).
Violations are categorized by severity and may require corrective action plans .
🛠 6. Repealed Sections & Recent Updates
NAC 652.600, which required Division‑approved technician training programs, was officially repealed as of this revision—it had been unused for many years (dpbh.nv.gov).
Other updates include more streamlined notification forms, modernized definitions, and adjusted qualification pathways for personnel .
✅ TL;DR Summary
Nevada’s Chapter 652 sets a robust framework for lab licensing and oversight, covering everything from application and inspection to personnel credentials and quality standards. The most notable recent change is the removal of outdated training approval rules (§652.600), making the regulations more efficient and current.
If you’d like details on a specific section—such as personnel qualifications, testing complexity rules, or inspection standards—let me know and I can dive deeper!Here’s an overview of the Nevada Administrative Code – Chapter 652: Medical Laboratories, which governs the licensing, operation, personnel, testing standards, and inspections for medical labs in Nevada.
📋 1. Scope & Definitions
§652.Sec. 1 (effective Oct 23, 2024): Requires labs to inform the Division of Public and Behavioral Health in advance of any changes—such as new tests, analytes, lab name, or testing methods—then undergo an inspection to check compliance with Chapter 652 (law.cornell.edu).
Classifies license types, including fully licensed labs, specimen-collection-only labs, exempt laboratories, and physician-operated labs (law.cornell.edu).
🏛 2. Licensing, Registration & Permitting
Initial & renewal applications must be submitted in the approved Division form, followed by facility inspection (leg.state.nv.us).
Physician-operated labs can be exempt (only waived tests on own patients) or nonexempt, with different fee and registration requirements (leg.state.nv.us).
Temporary lab permits (e.g., at special events) last up to 90 days .
👩🔬 3. Laboratory Personnel
Details roles, qualifications, and required certifications for:
Directors (licensed physicians, doctoral-level scientists, technologists) (leg.state.nv.us)
General supervisors, technologists, histotechnologists, technicians, and point-of-care analysts (law.cornell.edu)
Sets rules on temporary certifications and experience for trainees/new hires (leg.state.nv.us).
🧪 4. Testing Standards & Quality Control
Prescribes use of waived, moderate, or high-complexity tests defined by federal CLIA rules (42 C.F.R. Pt 493) (leg.state.nv.us).
Moderate/high complexity point-of-care testing is allowed only by qualified staff under proper training .
Emphasizes validation and instrument verification as part of compliance inspections (law.cornell.edu).
🔍 5. Inspections, Reporting & Compliance
Division conducts inspections upon license issuance/renewal or when a lab reports changes (law.cornell.edu).
Reports, proficiency testing, personnel training, lab safety protocols, access and accessioning documentation are mandatory (law.cornell.edu).
Violations are categorized by severity and may require corrective action plans .
🛠 6. Repealed Sections & Recent Updates
NAC 652.600, which required Division‑approved technician training programs, was officially repealed as of this revision—it had been unused for many years (dpbh.nv.gov).
Other updates include more streamlined notification forms, modernized definitions, and adjusted qualification pathways for personnel .
✅ TL;DR Summary
Nevada’s Chapter 652 sets a robust framework for lab licensing and oversight, covering everything from application and inspection to personnel credentials and quality standards. The most notable recent change is the removal of outdated training approval rules (§652.600), making the regulations more efficient and current.
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