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Biosafety Program

The goal of the Biosafety Program at the N.C. State Laboratory of Public Health is to plan, develop, and train policies and procedures which ensure a robust biosafety environment in public health and sentinel laboratories throughout North Carolina.

To address concerns that came to light during the U.S. response to Ebola, the US Centers for Disease Control and Prevention (CDC) allocated funds to 62 state and local health departments with the goal of enhancing laboratory biosafety and biosecurity across the nation.

As a recipient of these funds, NCSLPH was able to hire a Biosecurity Officer focused on biosafety and biosecurity across public health and sentinel clinical laboratories.  The NCSLPH Biosecurity Officer participates in updating biosafety guidelines and plans, conducting risk assessments, and identifying gaps and possible mitigation strategies in public health labs.

The links below were selected to provide biosafety guidance, informational documents, checklists, and training opportunities for public health and sentinel clinical laboratories in the State of North Carolina.

Please feel free to contact us with any questions, comments or requests for information.

Contact Information

Anna J. Liddicoat, MPH
Biosafety/Biosecurity Officer
Office: 919-807-8942
Mobile: 919-600-9611
Fax: 919-715-1840
Email


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 Guidance Documents

Biological Risk Assessment: General Considerations for Laboratories
The Centers for Disease Control and Prevention's Division of Laboratory Systems (DLS) has announced the publication of a new resource for laboratory professionals, the Biological Risk Assessment: General Considerations for Laboratories. The content introduces basic concepts, outlines steps for conducting the risk assessment process, and shares relevant resources for conducting a biorisk assessment.

Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Ed. - Biosafety guidance document. Based on risk assessment rather than regulations. Defines biosafety levels and common biosafety practices as well as pathogen-specific guidance.

Biological Risk Management for Point-of-Care Testing
The Centers for Disease Control and Prevention's Division of Laboratory Systems (DLS) has announced the publication of a new resource for those who perform point-of-care testing. The content introduces basic risk management concepts, outlines the five steps of the risk management process, and shares relevant resources. Website visitors can also download a job hazard analysis tool which they can adapt for their own situation. This webpage is a companion to the recently published Biological Risk Assessment: General Considerations for Laboratories released in March 2021.

Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories - Guidelines designed to promote a culture of biosafety safety and supplement the BMBL-5 by addressing the unique needs of the diagnostic laboratory. They are not requirements but recommendations that represent current science and sound judgment that can foster a safe working environment for all laboratorians.

Sentinel Level Clinical Laboratory Protocols for Suspected Biological Threat Agents and Emerging Infectious Diseases - Comprehensive protocol that covers all aspects of sentinel laboratory biosafety, biosecurity, risk assessment, and biomedical waste management.

World Health Organization (WHO) Laboratory Biosafety Manual - Biosafety techniques for use in laboratories at all levels. Topics include risk assessment, guidelines for the commissioning new laboratories, biosecurity, transport of infectious substances, and safety in health-care laboratories.

 Technical Documents

02/08/21: APHL COVID-19 Antigen Testing Biosafety Guidance - This document provides recommended biosafety practices to protect personnel and the work area from contamination with SARS-CoV-2 when collecting and testing specimens for COVID-19 using an antigen test.

01/28/21: Potential Hazards and Recommended Mitigation Procedures for COVID-19 Testing - This risk assessment template is for equipment used in COVID-19 testing in public health laboratories (PHLs). This document outlines potential hazards and mitigation procedures to assist PHLs with safely performing testing for SARS-CoV-2. Please keep in mind this risk assessment is not an all-encompassing plan as each facility will have to understand their laboratory specific risks associated with testing.

12/06/19: 2019 NC Medical Waste Management Rules; 15A NCAC 13B .1200 (PDF, 216 KB)

Risk Assessment and Risk Mitigation Protocol and Worksheet (DOCM, 113 KB) - Template designed to identify risks and risk mitigations associated with biohazards in the clinical laboratory setting.

Biosafety Cabinet Certifications in North Carolina (PDF, 16 KB) - OSHA fact sheet and a starting point for finding a certification resource.

01/16/20: Biosafety Plan Template - A guidance tool to aid in the process of assisting clinical laboratories in NC to develop BSL2 Biosafety Plans. This does not replace or supersede your institution's established guidelines, and any applicable local, state, and federal requirements. 

EPA Approved Disinfectant List - Lists of EPA-registered antimicrobial products that are effective against common pathogens. Use of the listed EPA-registered products consistent with the product labeling complies with the Occupational Safety and Health Administration‘s requirements for Occupational Exposure to Bloodborne Pathogens (29 CFR 1910) (also see Quick Reference Guide to the Bloodborne Pathogens Standard).

Association of Public Health Laboratories Best Practices in Risk Assessment - Defines key concepts and procedures in biological risk assessment and provides links to templates that are available for use.

Pathogen Safety Data Sheets - Describe hazardous properties of human pathogens and provide recommendations for work involving these agents in a laboratory setting. Produced by the Public Health Agency of Canada (PHAC) as educational and informational resources for laboratory personnel working with infectious substances.

CDC/APHL Guidelines for Biosafety Laboratory Competency - Guidelines for laboratorians working with hazardous biologic agents, obtained from either samples or specimens that are maintained and manipulated in clinical, environmental, public health, academic, and research laboratories. These guidelines for biosafety laboratory competency outline the essential skills, knowledge, and abilities required for working with biologic agents.

 Inspection Documents

APHL Clinical Laboratory Biosafety Risk Management Program Assessment Checklist - Checklist used to examine laboratory and practices and identify areas of risk for mitigation.

CDC BSL2 Laboratory Checklist - Based on BMBL-5 BSL2 recommendations. Used to inspect BSL2 select agent spaces but can be used to inspect non-select agent BSL2 spaces.

APHL Biosafety Checklist: Developing a Culture of Biosafety - Checklist for laboratory personnel performing testing on infectious agents or clinical specimens that could contain infectious agents. Provides laboratories with broad recommendations for components to be considered in a lab biosafety program.

 Free Web-Based Training

CDC TRAIN Fundamentals of Centrifuge Safety - This online course is designed for public health and clinical laboratory staff, safety professionals and persons interested in safe use of centrifuges. Topics include types of centrifuges, potential hazards, control measures to minimize hazards, safe work practices and what to do in the event of an emergency.

Duke Infectious Disease Response Training - Online training courses for individuals at risk of infectious disease exposure in their work place. Awareness, operations and train-the-trainer level training for healthcare and laboratory professionals. Topics include: Zika Virus Awareness, Infectious Disease Awareness, HIV Awareness, Biosafety Cabinet Awareness and Norovirus Awareness.

National Institutes of Health Biological Safety Cabinet (BSC): How it Works to Protect You - Short video demonstrates how biological safety cabinets provide protection to laboratory workers, product and the environment while reducing the risk of exposure. Thoroughly understanding how a biological safety cabinet works while following established lab safety protocols will help prevent contamination of your work and protect you at the same time.

Respiratory Protection Program Training and Resources - National Institute for Occupational Safety and Health (NIOSH) collaborated with the American Association of Occupational Health Nurses (AAOHN) on trainings and resources for designing a respiratory protection program.

CDC TRAIN - Fundamentals of Working Safely in a Biological Safety Cabinet - This basic-level eLearning course provides information on the safe use of Class II biological safety cabinets. Topics covered include major parts of a BSC, how a BSC works, how to work safely inside a BSC, and what to do if there is an emergency while working in a BSC. Videos, interactive exercises, job aids, and a modifiable checklist template are included in the course to enhance the learning experience.

Biosafety: Avoiding Lab Acquired Infections - Web-based course for laboratorians who handle biological and microbiological samples in clinical, reference, public health, animal, research, or teaching laboratories. Course topics include a background in biological agents and safety, including use of personnel protective equipment; pathogens of risk; and building safety into everyday laboratory practice. The course is designed to prepare individuals working in laboratorians to protect themselves properly from these agents, and to create a safe laboratory environment.

Biosafety: So Much More than PPE - Web-based course for laboratorians working in BSL-2 and BSL-3 laboratories. Topics include differences between biosafety and biosecurity, risk assessments, and standard and special biosafety practices for clinical labs.

Biosecurity for Clinical Laboratories - Designed by the State Hygienic Lab at the University of Iowa, this course is designed to help clinical laboratories improve their knowledge of biosecurity practices.

ABSA Basic Biosafety On-Demand Module - Provides direction to laboratorians on how to work more safely with biological hazards. The module contains sections on basic risk assessment, hazard control, chemical disinfection and offers biosafety resources.