Guidance & Policies, Respiratory Protection, External Resources, Association of Public Health Laboratories (APHL) APHL TB Self-Assessment Tool State Laboratory Of Public Health Biosafety Level Requirements, Related Information, Duke Regional Biocontainment Lab

Guidance & Policies, Lab Safety Manual – Biological Safety, External Resources, Duke Import/Export Permits USDA/APHIS Permits CDC Import Permits, Forms & Templates, A/BSL-2 SOP Template Animal Research with Biological Materials

Guidance & Policies, Sharps Management Plan Human materials in Animals rDNA in Animals, External Resources, Biosafety in Microbiological and Biomedical Laboratories (BMBL)/Animals NIH FAQs for Research on Genetically Modified (Transgenic) Animals, Forms & Templates, Guideline - LPS Guideline – Animal Specimens SOP template for BSL2/ABSL2 Labs, Related Information, Duke IACUC/OAWA Preventing Laboratory Animal Allergy Medical clearance

Guidance & Policies, Exempt Select-Toxin Policy Duke rDNA/IBC website Guideline-Biologically-derived substances Spills and Exposures, External Resources, NIH Guidance on Toxin Experiments, Forms & Templates, General Biotoxin SOP Template

Biological Materials, What is a biosafety level?, A biosafety level is an assigned containment, which consists of combinations of facility design features and safety equipment (primary and secondary b, I was told that my work must be conducted at a Biosafety Level-2 (BSL-2). What do I have to do?, Biosafety Level 2 (BSL-2) is suitable for work with agents associated with human disease and pose moderate hazards to personnel and the environment. S, What is a risk group?, Risk groups are assigned to microbes (agents). The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelin, What are safer sharps devices, and do we always have to use them?, Safer sharps devices are those needles and sharps used on patients or in laboratories that work with human blood or body fluids and tissues to help re

Non Select Toxins, What is a non-select toxin?, Non Select Toxins (biological toxins) are toxic substances that are produced or carried by microorganisms, animals, and plants.  Biological toxins are, What do I need to know about diphtheria toxin (DT)?, DT is useful in biomedical research using mice because it can be used to selectively target and kill cells or organs without requiring surgery. The Di, Where can I find an SOP template and guidelines?, SOP template for non-select toxins can be found here. , Do I have to register with the IBC?, Research at Duke University and Health System using recombinant DNA (rDNA) materials must comply with the NIH Guidelines for rDNA Research.  Experimen

Animal Research, When do I need to submit a biosafety SOP with my animal protocol?, If you will be using bacteria, virus, biologically-derived toxins, yeast/mold/fungi, mammalian cell lines submit an SOP to biosafety@duke.edu for asse, I am using recombinant DNA and/or viral vectors. How do I register this work?, Register the work with the Institutional Biosafety Committee (IBC) via email (biosafety@duke.edu) using this form. Submit your biosafety SOP(s) (where, I registered with the IBC. When will I get approval?, Registrations submitted to biosafety@duke.edu are reviewed for completeness. Once the IBC meets, biosafety@duke.edu will contact you with the results , IACUC says OESO has not cleared my protocol. Who do I contact to find out why?, Contact OESOAnimalProtocols@duke.edu.

A/BSL-3, When do I need to use an A/BSL-3 laboratory?, When working with biological materials that could cause serious or lethal disease through the inhalation route of exposure. , What are the prerequisites to work in an A/BSL-3 laboratory?, There are both medical clearances and specialized training needed to work in an A/BSL-3 lab. You must complete your medical clearance for respiratory

IBC, What is recombinant DNA?, Recombinant DNA (rDNA) was originally created by cutting DNA segments with restriction enzymes, then re-combining them in a ligation reaction. Today, , What is a viral vector?, The Duke IBC defines a viral vector as any rDNA molecule or molecules used to deliver nucleic acids to cells using viral proteins or their equivalents, What is a genetically-modified organism (GMO)?, A genetically-modified organism (GMO) is any organism whose genetic material has been altered using rDNA technology. Note that descendants of GMOs are, Do I have to register with the IBC?, All research at Duke University and Health System using recombinant DNA (rDNA) materials must comply with the NIH Guidelines for rDNA Research. Each i, What experiments involving toxin molecules require IBC registration?, Experiments involving the deliberate formation of recombinant or synthetic nucleic acid molecules containing genes for the biosynthesis of toxin molec, How do I register with the IBC?, For non-clinical studies, complete the IBC Recombinant DNA Registration form and submit it via e-mail to the Duke Biological Safety Office (biosafety@, How much work should be included on a single rDNA registration?, Each rDNA registration requires a descriptive title, and should cover a single area of research. Researchers who conduct rDNA research in multiple are, How do I submit an amendment to my registration?, For non-clinical studies, use your existing IBC registration and make modifications or additions to the work, while highlighting the newly added text., Does my registration expire?, Registrations require an annual review and renewal date. PIs will be notified annually and asked to complete an annual review form for continuing proj, I am using rDNA in collaboration with another faculty member. Do I have to register separately, or can I use the other faculty member's approved IBC r, A single registration can cover collaborative research in more than one lab if ALL the following conditions are met. (1) The collaborative research is, How do I respond to and report accidental exposures involving recombinant DNA?, Any potential exposures will be reported immediately by calling the Employee Occupational Health and Wellness (EOHW) exposure hotline (919-684-8115).

Tuberculosis (TB), When do I need respiratory protection? , When a patient is on Airborne Infection Isolation (AII). In order to enter the AII room, you need to put on respiratory protection: either a N95 or PA, What is Airborne Infection Isolation (AII)? , A patient is put on Airborne Infection Isolation when they have a suspected airborne illness. The patient is put into an Airborne Infection Isolation , What is a tissue test and when do I need to perform it? , A tissue test is a method to test the negative pressure of the AII room. Take a small piece of tissue and hold the tissue approximately 1 inch above t, If a suspected AII patient cannot be moved to an AII room, what do we do until the patient can be moved, and after they are moved?, If an AII room is not available, call for a Portable HEPA unit (see Appendix D in the TB ECP). After the patient is moved to an AII room, follow the g, What do I do if there’s a possible TB exposure? , Notify Biological Safety (biosafety@duke.edu) or Employee Health (919-684-3136).   Once a patient is confirmed to have TB, we will follow up with T, Who do I reach out to with other questions? , Please reach out to biosafety@duke.edu.   

Bloodborne Pathogens (BBP), Where can I find the requirements for work with BBP?, Depending on your location, see our ECP for Hospital and Clinics, Clinical Research Laboratories, Private Diagnostic Clinics, and Duke Primary Care or, How should BBPs be handled?, For work with human blood, body fluids, and other potentially infectious material (OPIM), such as human cell lines see our Universal/Standard Precauti, What to do in case of an exposure or spill?, See our Biological Exposure and Spills webpage for detailed instructions.  

Biological Waste, What is regulated medical waste?, Regulated medical waste means blood and body fluids in individual containers in volumes greater than 20 milliliters, microbiological waste, and pathol, What is biological waste?, Biological waste includes untreated regulated medical waste and biological materials generated from research, diagnostic, and/or teaching activities d, Does OESO pick up my biological waste?, No. OESO-Environmental Programs collects chemical, pharmaceutical, and radiological waste.  , How do I dispose of biological waste?, Review the information within the Duke Medical Waste Management Policy for guidance specific to the types of waste and your work location.  , Who do I contact for biohazard waste pickup?, In the hospital or medical center buildings: Environmental Services (EVS) at 919-681-9700.   In other locations, contact your departmental business , Help! The biological waste container is leaking. What should I do?, Put on PPE to cover all skin, eyes, nose, and mouth. Gather the components of your spill kit. Follow the instructions in the BIOLOGICAL section of the, Exposed to human blood or body fluid?, Eye/face exposure Rinse a minimum of 15 minutes in eye wash or flush with water. Immediately notify EOHW by dialing 115 from a Duke Phone or 919-684, What equipment should be labeled with a biohazard sticker?, Any machine that processes blood, body fluids, or other potentially infectious materials (OPIM). OPIM includes semen, vaginal secretions, cerebr, Do sharps containers need to be wall mounted or stabilized?, Containers must be wall mounted or placed on a stabilizing tray.   Containers must be upright and easy to use while preventing the contents from spi, In patient care areas, do red biohazard bins need a biohazard label?, No, in this case, the red color of the bins is sufficient to indicate a biohazard container. , Does the linen hamper need a biohazard label?, No, assigned blue bag is sufficient to identify soiled linen.  , Is soiled linen placed in a red bag?, No, red bags are not required.   Soiled linen should be placed in a fluid resistant bag. Blue bags are acceptable.   Linens soaked with fluids sho, Do soiled utility rooms need to be locked?, Depends on the amount stored in the room or the location. Joint Commission requirements state:  Rooms that store more than 64 gallons of trash o, Do soiled utility rooms need to have a label?, Yes, contact OESO at biosafety@duke.edu , Can I order biohazard labels from somewhere else?, No, for use in patient care or clinical care areas, all biohazard warning signs and labels for use in these areas must be distributed by OESO.   Fo, Where can I get a biohazard label?, Contact OESO at biosafety@duke.edu , Are biohazard labels required on a sharps container?, In laboratories, biohazard labels are required on sharps containers that contain infectious substances or human material.  In patient care or clini, What color should my sharps container be in patient care areas?, Red is preferred.   It can be any color but do not use blue containers to avoid confusion with the blue bin program (pharmaceutical waste) container

Shipping Biological Material, Who needs Biological Materials Shipping training?, Anyone who classifies materials, prepares paperwork, and/or prepares packages of biological materials for shipping must complete appropriate training , What regulations do I need to follow?, The U.S. Department of Transportation Hazardous Materials Regulations (HMR) have aligned with international regulations (ICAO/IATA). If you follow the, I am shipping an exempt patient specimen for routine lab testing. What do I need to know?, You need to take OESO Shipping Biological Materials Training. Exempt patient specimens (containing no other hazardous materials) for which there is mi, Can I transport patient or research lab specimens using a Duke vehicle?, Biohazard and potentially infectious material sample transportation is PROHIBITED on public                      transit, but vehicles dedicated for p, Can I transport research lab specimens using a private vehicle?, Specimens may be transported by private or contract carrier vehicle that used exclusively for these materials. When lab specimens are transported acro, What is an Infectious Substance, Category B?, An infectious substance which does not meet the criteria for inclusion in Category A. Infectious substances in Category B must be assigned to UN 3373., What is an Infectious Substance, Category A?, An infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening