Nevada Administrative Code Chapter 652 - Medical Laboratories
1. Licensing Requirements for Medical Laboratories (NAC 652.090 – NAC 652.120)
Summary:
Any laboratory performing tests on human specimens for health-related purposes in Nevada must be licensed by the state. Licenses are categorized depending on the type and complexity of testing performed.
Case Example:
A small clinic in Reno wants to start offering blood glucose and cholesterol testing on-site. The lab must:
Submit an application to the Nevada State Health Division.
Show that their personnel are qualified (i.e., have certified lab technologists or technicians).
Pass an inspection that verifies equipment, procedures, and recordkeeping meet state standards.
Implication:
Even small in-office labs cannot operate without a license. If they do, they can face fines or closure.
2. Personnel Qualifications and Supervision (NAC 652.150 – NAC 652.170)
Summary:
Laboratories must employ qualified personnel and ensure that all testing is supervised by a licensed laboratory director. Specific qualifications vary depending on the complexity of tests (waived, moderate, or high complexity).
Case Example:
A pathology lab wants to perform PCR-based infectious disease tests:
The lab director must have a doctoral degree in a related field (MD, PhD, or equivalent) and specific lab experience.
Laboratory technicians must be certified to handle high-complexity testing.
Implication:
Hiring unqualified personnel can lead to invalid test results, legal liability, and revocation of the lab’s license.
3. Proficiency Testing Requirements (NAC 652.200 – NAC 652.210)
Summary:
Certain labs must participate in proficiency testing programs to ensure accuracy. This involves running standardized samples from an external agency and reporting results for review.
Case Example:
A hospital laboratory running HIV testing must:
Enroll in a state-approved proficiency testing program.
Perform blind testing on samples sent from the program quarterly.
Correct any discrepancies found during proficiency evaluation.
Implication:
Proficiency testing ensures patient safety. A lab failing these tests repeatedly may have its license suspended.
4. Records and Reporting (NAC 652.230 – NAC 652.270)
Summary:
Labs must maintain complete records of all tests, patient information, quality control data, and test results. Certain results (like communicable diseases) must be reported to the state health authorities.
Case Example:
A laboratory discovers a case of tuberculosis (TB) in a patient:
The lab must report the positive result to the Nevada Division of Public and Behavioral Health immediately.
Records must include patient identifiers, test method, results, and personnel who performed the test.
Implication:
Failure to report not only risks public health but also legal consequences for the lab.
5. Inspections and Compliance (NAC 652.300 – NAC 652.330)
Summary:
The state has the authority to inspect laboratories to ensure compliance with NAC 652. Inspections can be scheduled or unannounced.
Case Example:
During an inspection, a lab in Las Vegas is found storing reagents at incorrect temperatures:
Inspectors note the violation and issue a corrective action plan.
The lab must implement the corrective measures and demonstrate compliance within a set timeframe.
Implication:
Repeated or severe violations can result in fines, suspension, or revocation of the lab license.
6. Special Rules for High-Complexity Testing (NAC 652.350 – NAC 652.380)
Summary:
High-complexity tests (e.g., molecular diagnostics, cytogenetics) have stricter requirements for personnel, equipment, and quality assurance.
Case Example:
A lab performing next-generation sequencing for cancer diagnosis must:
Validate each test before offering it to patients.
Maintain rigorous quality control and documentation.
Have a high-complexity lab director oversee all procedures.
Implication:
High-complexity labs face the highest scrutiny because errors can have severe patient consequences.
7. Suspension, Revocation, or Denial of License (NAC 652.400 – NAC 652.430)
Summary:
The state can deny, suspend, or revoke a license for violations, fraudulent reporting, or unsafe practices.
Case Example:
A lab repeatedly falsifies quality control records:
The Division issues a notice of intent to revoke the license.
The lab has the right to a hearing but must cease operations until the matter is resolved.
Implication:
This ensures patient safety and maintains trust in laboratory testing.
✅ Summary:
NAC Chapter 652 regulates the operation, personnel, quality, and reporting obligations of medical laboratories in Nevada. Key areas include licensing, personnel qualifications, proficiency testing, records, inspections, high-complexity testing, and enforcement. Each “case” illustrates how the rules apply in real-life laboratory settings, showing the balance between patient safety, scientific accuracy, and legal compliance.
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