Nevada Administrative Code Chapter 460 - Human Blood and Blood Products

Overview of NAC Chapter 460: Human Blood and Blood Products

This chapter sets forth the administrative rules and requirements for entities involved in:

Collecting

Testing

Processing

Storing

Distributing

Using human blood and blood products in Nevada.

The purpose is to protect recipients of blood transfusions and related products from risks such as infectious diseases and to ensure quality and safety standards are met.

Key Areas Covered in Chapter 460

1. Licensing and Registration

Facilities that collect, process, or distribute human blood and blood products must be licensed or registered with the Nevada State Health Division.

Licensing requirements include compliance with state and federal regulations.

Renewal procedures and fees for licenses are specified.

2. Standards for Collection and Processing

The chapter defines standards and protocols for the safe collection of blood, including donor eligibility criteria.

Requirements for testing blood for infectious agents like HIV, Hepatitis B and C, syphilis, and other transmissible diseases.

Procedures to ensure the quality and safety of blood products during processing and storage.

3. Labeling and Packaging

Blood and blood products must be properly labeled with information such as donor identification, testing results, expiration dates, and handling instructions.

Packaging requirements to prevent contamination or damage during transport.

4. Recordkeeping and Reporting

Facilities must maintain detailed records of blood collection, testing, distribution, and transfusion.

Reporting requirements for adverse events, including transfusion reactions or suspected contamination.

The State Health Division may conduct inspections and audits of records.

5. Inspection and Enforcement

The chapter authorizes state health officials to inspect blood banks, processing facilities, and related entities to ensure compliance.

Procedures for investigations if violations are suspected.

Possible penalties for noncompliance, including fines, license suspension, or revocation.

6. Donor Eligibility and Protection

Guidelines for evaluating donor health to minimize risks.

Confidentiality and consent requirements for donors.

Procedures for deferral or exclusion of donors based on health or risk factors.

Purpose and Importance

To ensure public safety in medical procedures involving blood transfusions.

To minimize the risk of transmission of infectious diseases through blood products.

To promote uniform standards aligned with federal laws (such as FDA regulations) and best medical practices.

To provide a legal framework for oversight of blood banks and related facilities.

Summary

SectionDescription
LicensingRequirements for blood banks and processing centers
Collection StandardsDonor criteria and collection protocols
Testing RequirementsMandatory infectious disease testing
LabelingInformation and packaging of blood products
RecordkeepingDocumentation and reporting obligations
InspectionsState authority to inspect and enforce rules
PenaltiesConsequences for violations

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