LM_Biosafety_eBook_2024 (1) BIOSAFETY RESOURCE GUIDE Working safely at each biosafety level "HIDDEN" biological safety levels ESSENTIAL biosafety practices DEVELOPING an exposure control plan Table of Contents
3 Navigating Biosafety 6 Biological Safety Levels 1, 2, 3, & 4 10 The "Hidden" Biosafety Levels 13 Biosafety in the Workplace: Four Essential Practices 16 Proper Sequencing of PPE Use 19 Inspired Workplaces, Safe Environments: Lab Designs for All Biosafety Levels 23 Working with Biohazards 2 Lab Manager
26 Preparing for a Health and Safety Compliance Audit Introduction
Navigating Biosafety Understanding the risks and implementing essential workplace practices Biological safety levels were developed to protect laboratory workers against various agents including bacteria, fungi, parasites, and more grouped by risk level. Adhering to precau- tions and practices outlined in each biological safety level (BSL) is critical to ensure a safe workplace. The BSL1 through BSL4 classifications cover a wide range of biological agents, safe work practices, specialized safety equipment, and facility design. Some biological agents, however, do not fit perfectly into a specific BSL and require some modifications of BSL2 and BSL3 to create BSL2+ and BSL3+. It is important to consider agents, processes, and enhanced practic- es when assessing and managing risk. The goal of a biosafety program is to protect staff, the public, and the environment from ex- posure to various biological agents. There are many practices labs can implement to strength- en biosecurity, starting with a biological risk assessment. Using proper personal protective equipment (PPE)-and donning it correctly-working in well-designed facilities, following good laboratory techniques and practices, and fostering a commitment to safety in the lab also enhance biosecurity. Labs must also have an exposure control plan (ECP) to maintain workplace safety. An ECP is essentially a biohazard safety manual that includes risk assessment, standard operating proce- dures, training, exposure incident response, and record keeping. Introduction In the United States, Occupational Safety and Health Administration (OSHA) sets and enforces standards to ensure safe and healthy working conditions, many of which apply to research laboratories. In other countries, a relevant regulatory body will fulfill this need. Lab leaders must identify and minimize common hazards, and be prepared for a health and safety audit. Safety is a top priority for any laboratory working with biological agents, requiring a robust biosafety program and adherence to safety practices. This resource guide provides detailed insights on how to enhance biosafety in your laboratory. There is detailed information on each BSL classification and an in- depth look at how labs can be designed to meet their BSL and still be comfortable and inviting workplaces. The guide outlines several practices for enhancing biosafety and includes a helpful graphic demonstrating the procedure for donning PPE items. There is also valuable information on how to create an exposure control plan and how to prepare for a health and safety audit. Product Spotlight Baker's SterilGARD®, the optimal balance of performance and efficiency. Baker builds it better! As the pioneer and leading innovator of air containment, contamination control and precision cell culture products, Baker doesn't take shortcuts when it comes to protecting you or your research. The SterilGARD® e3 Class II, Type A2 biosafety cabinet offers you the highest level of performance and comfort, along with energy efficiency. Baker's exclusive technologies, including StediFLOW™, ReadySAFE™ and UniPressure™ Preflow Plenum, work together to deliver unparalleled safety and performance and increased productivity. A significant reduction in energy consumption and heat rejection yields a 70% savings in annual operating costs. Our high-performance laboratory equipment is built with you in mind, with industry-leading ergonomics and the lowest life cycle costs available. The most reliable, comfortable and safe A2 cabinet in the industry. With the optimum balance of performance and energy efficiency, our BSCs protect personnel, product and the environment, all while increasing lab productivity and user comfort.
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Biological Safety Levels 1, 2, 3, & 4 Each biological safety level builds on the previous level, adding constraints and barriers based on the agents or organisms in which the research or work is being conducted by Vince McLeod, CIH, and Jonathan Klane, M.S.Ed., CIH, CSP, CHMM, CIT Biological safety level basics A very specialized research laboratory that deals with infectious agents is the biosafety lab. Thhether perform- ing research or production activities, when working with infectious materials, organisms or perhaps even laboratory animals, the proper degree of protection is of utmost impor- tance. Protection for laboratory personnel, the environment, and the local community must be considered and ensured. The protections required by these types of activities are defined as biosafety levels. Biological safety levels are ranked from one to four and are selected based on the agents or organisms on which the research or work is being conduct- ed. Each biological safety level builds on the previous level, adding constraints and barriers. The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) are our main sourc- es for biological safety information for infectious agents. As an introduction, we summarize what the different biosafety levels encompass in terms of the typical biological agents used, safe work practices, specialized safety equipment (pri- mary barriers) and facility design (secondary barriers). The four biosafety levels (BSLs) were developed to protect against a world of select agents. These agents include bacteria, fungi, parasites, prions, rickettsial agents, and viruses, the latter being probably the largest and most important group. In many instances, the work or research involves vertebrate animals, from mice to cattle. Thhen vertebrates are involved, additional precautions and safety requirements are necessary. Using the most infectious agents also means extensive securi- ty measures are in place, not only because of their virulence but also because of their potential for use in bioterrorism. Level 1 Biological safety level one, the lowest level, applies to work with agents that usually pose a minimal potential threat to laboratory workers and the environment and do not consis- tently cause disease in healthy adults. Research with these agents is generally performed on standard open laboratory benches without the use of special containment equipment. BSL1 labs are not usually isolated from the general build- ing. Training on the specific procedures is given to the lab personnel, who are supervised by a trained microbiologist or scientist. "The four biosafety levels were developed to protect against a world of select agents. These agents include bacteria, fungi, parasites, prions, rickettsial agents and viruses, the latter being probably the largest and most important group." Standard microbiology practices are usually enough to pro- tect laboratory workers and other employees in the building. These include mechanical pipetting only (no mouth pipet- ting allowed), safe sharps handling, avoidance of splashes or aerosols, and decontamination of all work surfaces when work is complete, i.e., daily. Decontamination of spills is done immediately, and all potentially infectious materials are decontaminated prior to disposal, generally by autoclav- ing. Standard microbiological practices also require attention to personal hygiene, e.g., hand washing and a prohibition on eating, drinking, or smoking in the lab. Normal laboratory PPE is generally worn, consisting of eye protection, gloves, and a lab coat or gown. Biohazard signs are posted and access to the lab is limited whenever infectious agents are present. Level 2 Biological safety level two (BSL2) would cover work with agents associated with human disease, in other words, patho- genic or infectious organisms posing a moderate hazard. Examples are the equine encephalitis viruses and HIV when performing routine diagnostic procedures or work with clin- ical specimens. Therefore, because of their potential to cause human disease, great care is used to prevent percutaneous injury (needlesticks, cuts, and other breaches of the skin), in- gestion, and mucous membrane exposures in addition to the standard microbiological practices of BSL 1. Contaminated sharps are handled with extreme caution. Use of disposable syringe-needle units and appropriate puncture-resistant sharps containers is mandatory. Direct handling of broken glassware is prohibited, and decontamination of all sharps prior to disposal is standard practice. The laboratory's writ- ten biosafety manual details any needed immunizations (e.g., hepatitis B vaccine or TB skin testing) and whether serum Biological safety training For biosafety training, you can follow some of the key adult learning principles. Make it: Be sure to focus on all three KSAs (knowledge, skills, and attitudes). Information helps us understand hazards. Skills allow us to perform necessary actions and hands-on manipulations. But it's our attitudes that drive our behaviors and help achieve a culture of safety. banking is required for at-risk lab personnel. Access to the lab is more controlled than for BSL 1 facilities. Immuno- compromised, immunosuppressed, and other persons with increased risk for infection may be denied admittance at the discretion of the laboratory director. BSL 2 labs must also provide the next level of barriers, i.e., specialty safety equipment and facilities. Preferably, this is a Class II biosafety cabinet or equivalent containment device for work with agents and an autoclave or other suitable meth- od for decontamination within the lab. A readily available eyewash station is needed. Self-closing lockable doors and biohazard warning signs are also required at all access points. Level 3 Yellow fever, St. Louis encephalitis, and Thest Nile virus are examples of agents requiring biological safety level 3 (BSL3) practices and containment. Thork with these agents is strictly controlled and must be registered with all appropriate gov- ernment agencies. These are indigenous or exotic agents that may cause serious or lethal disease via aerosol transmission, i.e., simple inhalation of particles or droplets. The pathoge- nicity and communicability of these agents dictates the next level of protective procedures and barriers. Add to all the BSL 2 practices and equipment even more stringent access control and decontamination of all wastes, including lab clothing before laundering, within the lab facility. Baseline serum samples are collected from all lab and other at-risk personnel as appropriate. More protective primary barriers are used in BSL 3 labora- tories, including solid-front wraparound gowns, scrub suits or coveralls made of materials such as Tyvek® and respirators as necessary. Facility design should incorporate self-clos- ing double-door access separated from general building corridors. The ventilation must provide ducted, directional airflow by drawing air into the lab from clean areas and with no recirculation. Level 4 Agents requiring biological safety level 4 (BSL4) facilities and practices are extremely dangerous and pose a high risk of life-threatening disease. Examples are the Ebola virus, the Lassa virus, and any agent with unknown risks of pathoge- nicity and transmission. These facilities provide the maxi- mum protection and containment. To the BSL 3 practices, we add requirements for complete clothing change before entry, a shower on exit, and decontamination of all materials prior to leaving the facility. The BSL 4 laboratory should contain a Class III biological safety cabinet but may use a Class I or II BSC in combination with a positive-pressure, air-supplied full-body suit. Usually, BSL 4 laboratories are in separate buildings or a totally isolated zone with dedicated supply and exhaust ventilation. Exhaust streams are filtered through high-efficiency particu- late air filters, depending on the agents used. The have touched on only the main issues and differences be- tween BSL 1, 2, 3, and 4 laboratories. There are many other concerns and requirements addressed in the CDC manual, such as impervious, easy-to-clean surfaces; insect and rodent control; and total barrier sealing of all wall, floor, and ceiling penetrations. Our goal was to introduce you to the differ- ent levels of biological safety practices and facility design considerations. Hopefully, you now have the knowledge to decide whether you should open that door or not. Biohazardous waste management Biohazardous wastes are different from chemicals or ra- dioactive waste. Chemicals can react badly, and rad wastes continue to radiate. But our major focus for bio-waste is preventing transmission or infection. So, how can you best control infectious substance waste? Disinfect, decontami- nate, sterilize, or incinerate. Alcohol and bleach are used daily to disinfect surfaces in labs. Other potent chemicals (e.g., aldehydes or ethylene oxide) are available to sterilize bio-wastes. Heat is a common method mostly via autoclaves and similar enclosed sys- BIOSAFETY 1,2,3,4 Established by the National Institutes of Health (NIH) and Centers for Disease Control (CDC), biosafety levels 1 through 4 represent a collection of laboratory techniques, practices, and equipment used to manage the biohazards posed when working with various infectious agents. 01 BIOSAFETy LEvEL 1 INFECTIOUS AgENTS Strains of viable micro-organisms that usually pose a minimal potential threat to laboratory workers and the environment and do not consistently cause disease in healthy adults. PRACTICES Standard microbiological practices SAFETy
Working with infectious agents requires specific care and equipment. Download this free infographic, courtesy of Lab Manager, that you can keep as a reference for your lab. tems both in the lab and elsewhere. During the COVID-19 pandemic, vaporized hydrogen peroxide (H2O2) was used to decontaminate N95 respirators in short supply. UV lights are ubiquitous within certain controls. And of course, there's al- ways incineration, though it comes with environmental woes. Containers are needed for most bio-wastes including bags, sharps containers, and lines boxes or bins. Often the biggest challenge is managing safe sharps use and disposal (e.g., sy- ringes, needles, razor blades, slides, cover slips, broken glass). References:
The "Hidden" Biosafety Levels Most lab professionals know four biosafety levels, but BSL2+ and BSL3+ are also important to know by Jonathan Klane, M.S.Ed., CIH, CSP, CHMM, CIT Almost all biosafety references, sources, or articles describe four biological safety levels. But what if your lab needs an- other level for certain hazardous agents or riskier processes? Aren't there just four biosafety levels (BSLs)? Yes and no. There are four BSLs as we know from many sources-even the Biosafety in Microbiological and Bio- medical Laboratories, or BMBL, lists four biosafety labs as BSL1 through BSL4. But sometimes, biohazards and our processes don't fit neatly into a certain level. Sometimes we need an in-between level to manage elevated risks by using enhanced practices. Why are there two BSL+ levels? Think of the myriad agents as being on a spectrum with many offshoots. Most can be fit into four risk groups well enough as is. A few of the agents don't fit well, and sometimes the pro- cesses in use increase the risks. So, we need to modify BSL2 and BSL3 for these few times. These vary between BSL labs and organizations with labs. One constant is that there isn't one consistent list of these. Specific risk assessments are key. Does your lab need BSL2+ or BSL3+? BSL2+ BSL3+ Agents • Viruses + bacteria causing severe or fatal disease with treatment or vaccines How to decide if your lab needs to use a BSL2+ or BSL3+ Lab Safety Management Certificate
Embark on an educational journey in lab safety with the Lab Safety Management Certificate program from Lab Manager Academy. We understand that navigating protocols and best practices for the various biosafety levels can be complex, and we're here to support you every step of the way. Our program empowers you to foster an effective safety culture, mitigate risks, and become a lab safety leader. Discover more about the Lab Safety Management Certificate program here. It's all about risk. If your lab has pathogens or agents in a BSL2 or BSL3 lab with processes that increase risks, you may need to implement a +level approach. Assess your lab and process-specific risks, then decide based on the risk analysis. "Completing the Lab Safety Management Certificate program has been a game-changer for my career. The practical knowledge and skills I gained have not only made me a better professional but also positioned me as a leader in my field." Shannon C. Nephew, MS, CSM, CCHO Chemical Hygiene Officer Hudson Hall Science Complex Building Manager State University of New York Plattsburgh Are you ready to take your career to new heights? Lab Manager Academy presents the Lab Safety Management Certificate program, designed to empower professionals like you to become safety leaders in the laboratory environment. Through our comprehensive curriculum, expert-led instruction, and flexible learning approach, you will gain the essential knowledge and skills you need to excel in lab safety management. Comprehensive Curriculum Dive into 12 online courses covering topics such as risk assessment, compliance management, safety culture development, and emergency preparedness. Specialized Skill Enhancement Acquire specialized lab safety skills, making you a more qualified candidate for promotions, leadership roles, and increased responsibilities within your organization. Accelerated Learning with Expert Instruction Gain valuable insights from seasoned lab safety professionals to fast-track your understanding of safety strategies and their real-world applications. Work-Life Balance Enjoy the flexibility of a self-paced learning format that eliminates scheduling constraints, making it easier to improve your skills without disrupting your daily life. Ready to Become a Safety Leader? Don't miss out on this opportunity to elevate your career and make a difference in lab safety. Enroll now and take the first step toward becoming a safety leader today! Visit academy.labmanager.com or scan to learn more and enroll today! Scan Me! Certificate Price Price: $949 *Corporate rates available for enrolling five or more lab professionals!
Biosafety in the Workplace: Four Essential Practices Best biosafety practices reduce health risks, increase the integrity of experimental material, and improve product quality by Morgana Moretti, PhD The main goal of a biosafety program is to protect staff, the public, and the environment from exposure to infectious biological agents, toxins, and bioactive substances. Apart from preventing laboratory-acquired infections in academic and industrial settings, a good biosafety program ensures the production of sterile preparations in the pharma- ceutical industry and aseptic processing in food and bever- age manufacturing. Good biosafety practices can also limit microorganism transmission between patients and control environmental risks of infection in hospitals and other health care facilities. Failure to follow biosafety protocols increases the risk of exposure to biohazards and reduces the integrity of experimental material and products. This article outlines four essential practices to strengthen biosecurity in the workplace. A correct laboratory engineering design and the proper use of safety equipment alone are not sufficient. Good laboratory techniques and practices are core components of safety in the workplace, too. Good laboratory practice encompasses several working methods that minimize workplace contamination. These in- clude good hygiene practices, using manipulation techniques that reduce aerosol production, ensuring mouth or eyes remain untouched, and never working alone in a laboratory setting. Exposure and injuries are more likely to occur in poorly maintained, disorderly areas, so keeping the laborato- ry clean and tidy is also critical for maximum efficiency and safety. Laboratory personnel should also understand their roles and be instructed to perform their duties in emergen- cies, from power outages to incidental spills or deliberate malicious acts. Some instances of effective strategies that leaders can use to foster biorisk management are: (I) awareness of biohazard risks, (II) periodic training to improve education, and (III) audited adherence to standard procedures. A safety manual that includes laboratory spill and emergency procedures must also be available to and followed by all the staff. Culture matters Academic and industrial laboratories are complex envi- ronments with many hazard categories. The safety of all employees, the community, and the environment depends on mandatory safety rules and an ongoing commitment to them. Thhen biosafety is a shared priority, people recognize the value of reporting their concerns, openly share information, and take action whenever needed. Leaders can demonstrate their commitment to safety by sup- porting the organization in learning about errors, investigat- ing their causes, developing strategies to prevent them, and sharing the lessons learned with staff. Mindset change takes a long time, so leaders' safety messages must be consistent and sustained. Surveys measuring staff perception of safety culture are often valuable tools to assess the presence of a culture of safety in an organization. A culture that empha- sizes biosafety should be characterized by both individual and institutional compliance with biosafety and laboratory biosecurity regulations, guidelines, standards, policies, and procedures. In addition to the practices outlined here, biosecurity can be complemented by the following: clear definition of roles and responsibilities, competency-based training, safety performance measurement, inspections and audits, medical surveillance, and vaccination. Laboratory accreditation and certification may also help ensure that laboratories imple- ment biosafety measures according to the standard guide- lines. Altogether, these procedures ensure a safe environ- ment, both within and outside the laboratory.
Proper Sequencing of PPE Use Recommended procedures for donning and doffing PPE to prevent cross- contamination by Vince McLeod, CIH <pull quote> Failure to follow protocols could potentially put you, your coworkers, and others in danger or at risk. Contamination could cause personnel illness, loss of many hours of research, and possible huge financial losses. Specialized containment labs are also increasingly necessary for clinical, diagnostic, production, and research facilities. The specific personal protective equipment (PPE) required strictly depends on the type of containment area and the ongoing research. This article provides a generic procedure that can be tailored to fit most any containment lab or clean- room, both sterile and non-sterile. Containment lab general setup Containment laboratories are constructed so that the entire room is a secondary containment barrier.1 That is, the lab space ventilation is kept pressurized slightly negative relative to the adjacent areas. This is to maintain an inward direc- tional airflow by exhausting more air than is supplied. Thus, any contaminants from spills or releases are prevented from migrating into surrounding areas. The laboratory exhaust must vent directly to the outside air with no recirculation. Depending on the research and materials in use, in most cases, the exhaust air must also be filtered, usually with high efficiency particulate air filters.1 Ideally, separate areas are provided for entry and gowning-in versus de-gowning and exit, although many facilities use a single access for entry and exit. Thhether one-directional or not, the ingress/egress point(s) should use a two-stage pro- cess: a pregowning area where the process is started followed by the gowning or PPE donning room. In a model facility, exit is via a separate de-gowning room proceeding then to final clearance and exit. Airflow is strictly controlled in these areas to fully contain any contaminants. Pre-gowning precautions Prior to beginning the process of entering or using a clean- room or containment lab, ensure your standard operating procedures (SOPs) and protocols are clearly and concisely written and all employees (entrants) are thoroughly trained. Your written SOP should: Minimize the use of make-up, hair gel, body lotions, and personal skin care products as these can potential- ly introduce contaminants. Users should not smoke within 45 minutes of entering, especially cleanrooms, as it is well-documented that smokers shed particulates for much longer than 30 minutes after smoking. Remove extraneous street clothing such as sunglasses, hats, jackets, etc. before entering the antechamber to simplify the process and minimize needed actions. Plan out the work in advance so all materials, tools, solutions, etc. are on hand and ready to minimize traffic and the number of entries/exits. A recommended gowning procedure The following graphic demonstrates the procedure for a basic level containment lab or cleanroom and provides a generic order for donning PPE items. The sequence is designed to help control contamination when donning and removing standard containment/cleanroom PPE. Not every apparel article is needed in all cases. Check your facility's procedures. If you are dealing with highly infectious or toxic agents or working in a highly sterile lab (pharmaceutical preparations, FDA regulated lab, etc.), then additional steps and much stricter protocols will be necessary.2 After following the steps outlined in the "Donning PPE" section of the graphic on the following page, you are ready to enter the cleanroom or containment lab. Upon completion of your work, exiting the containment area is generally the re- verse of those steps. However, there are important consider- ations, so a list of the full steps is also featured in the graphic. Thork in containment labs and cleanrooms is always serious business. Failure to follow protocols could potentially put you, your coworkers, and others in danger or at risk. Con- tamination could cause personnel illness, loss of many hours of research, and possible huge financial losses. The PPE requirements are put in place for critical and specific reasons. Be patient and properly gown in and out every time you enter a containment area. And remember-safety first! References: Entering Procedure (Donning PPE) De-gowning and exiting STEP 01 Don bouffant cap and beard cover and make sure all hair is covered. STEP 02 Don shoe covers, tucking in all laces, tassels, etc. STEP 01 Remove boot/shoe covers and, if wearing two pairs of gloves, discard the outer pair of gloves. If only one pair of gloves is worn, they will be removed last. If boot covers will be reused, store in separate proper container. STEP 03 Select, inspect, and clean safety glasses and then don. STEP 05 Don facemask (N95, N100, etc.) and bend nosepiece to snug fit on bridge of nose. STEP 07 STEP 04 Don gowning gloves (usually required for sterile environments). STEP 06 Don hood (if separate and required, usually a part of coverall gown) and secure face and neck seal. STEP 02 Remove coverall gown. If gown will be reused, hang in approved and controlled area. Otherwise discard. STEP 04 Remove hood and follow same steps as gown if reused. STEP 06 STEP 03 Remove eyewear; clean and place in proper storage container. STEP 05 Exit gowning room and enter antechamber. STEP 07 Don coverall gown. Make sure gown does not touch floor by gathering leg and arm cuffs first and releasing one at a time. See Sterile Preparations Manual for a good description of this process.2 If a separate hood is used, tuck shoulder panels inside and under gown before zipping up. Remove and discard facemask. STEP 08 Remove and discard bouffant cap. STEP 09 STEP 08 STEP 09 Don boot/shoe covers and pull over outside of gown legs. Don second pair of gloves and stretch over gown sleeve cuff. Remove and discard shoe covers. Remove and discard inner pair of gloves (if applicable).
Inspired Workplaces, Safe Environments: Lab Designs for Al Biosafety Levels Safe lab design begins with meeting the appropriate BSL rating by Robert Skolozdra Are inspiring and magnetic research facilities incompatible with safe and efficient ones? Hardly. Productive laborato- ries that advance scientists' and researchers' life-chang- ing discoveries can also be safe environments that inspire innovation. It's about creating labs that meet their designated biosafety level (BSL) in spaces that are as comfortable and inviting as they are effective and benign. Savvy lab managers know that safe and effective lab designs begin with meeting the scientific environment's BSL rating of 1 to 4. Thith the levels tied to progressively stringent safety systems associated with the health risk of the infec- tious agents stored and used within the facility, state-of-the- art lab designs go beyond integrating required BSL safety measures to creating dynamic workplaces for groundbreak- ing research. Meeting biosafety levels Installing a door and lock may be a simple enough approach to safeguard lower-rated BSL labs against outside con- taminants and vice versa, but the more involved measures required for higher-level BSLs often require a heightened design approach. Self-closing double doors, air locks, show- ering stations, and other critical safety measures necessitate careful attention to a lab's layout and working environment. Perceptive design solutions prevent sensitive materials' un- intended access and the chance of biological agents harming scientists or those living in the surrounding communities; ef- fective creative designs also provide researchers and lab staff with comfort and peace of mind while working in the spaces. As an example, the new headquarters for biotechnology com- pany Halda Therapeutics, situated in the former Thinchester Arms factory in New Haven, CT, incorporates glass parti- tions treated with a film that obscures private information and images on screens. This provides a connected sense of openness without compromising access to data. Connecting with consultants Early and continued close communications and coordination among team members, client representatives, and safety and systems consultants results in engaging lab designs that effectively and beautifully meet their required BSL. These inspired spaces often rely on specialized experts to ensure the workplaces' absolute safety and that of the surround- ing community. The expertise of a vivarium specialist or veterinarian, for instance, can provide essential measures to protect animals and people against dangerous infections in BSL 1 through 4 vivariums where research involving animals is conducted. Key consultations for the design of the transgenic butter- fly BSL2 lab at a private university, for instance, resulted in designated safeguards that prevent the different types of butterfly populations under research there from mixing with each other and causing unwanted transgenic breeding. Air lock vestibules with interlocking doors that prevent two doors from being open simultaneously, and air curtains to brush off any potential escaping butterflies, are two such proven solutions. Designing productive, welcoming labs begins with collab- orative dialogue between design firms and clients, with designers asking open-ended questions. These sessions establish what needs to be protected and isolated to meet the appropriate BSL level, with additional consultants advising as required. The success of resulting labs is achieved through the design process. Often, a well-conceived and executed design solu- tion is required to mitigate a potentially hazardous situation. To create the BSL2 lab at Arvinas, a biotechnology company based out of New Haven, CT, close coordination between the design team, safety consultant, and mechanical engineer brought attention to the need to protect waste streams and lab staff from the lab's fine powder refuse. The resulting cus- tomized lab design approach ensured the safe and effective management of the refuse. This includes systems for how the lab equipment is cleaned, how the containment and periodic pumping of associated waste are conducted, and how the room housing the material is washed, along with systems for the proper disposal of the refuse. Bolstering infrastructure and systems Thhile higher costs are associated with the implementation of a building's robust infrastructure-which often is needed to support heavy equipment and systems used by labs, especially at BSL3 or higher-an initial financial outlay for the structures and systems may provide savings in the long run. Even at lower BSL levels, advancing the lab's design to support heftier equipment and systems, such as an extensive plumbing network, can help ease the cost of subsequent lab expansions and the potential of a higher BSL rating. For instance, the infrastructure at the existing building renovat- ed to create the new Elm City Bioscience Center-a biotech hub for start-up science, laboratory, and research compa- nies in New Haven, CT-was upgraded to meet the safety, mechanical, electrical, and plumbing systems needs of both BSL1 and BSL2 biotech tenants. This provides flexibility for the tenants' present and future needs. The mitigation of vibration levels can also be a factor, espe- cially for higher BSL facilities, with the labs' weighty equip- ment popularizing the often less costly structural advantages of locating them in a building's lower levels. Chemical and hazard storage often is reduced at higher floors, as well as the least hazardous materials typically located on upper floors along with separate office spaces. The level on which a lab is located can also lessen accommodations for fire rating requirements. Incorporating art and biophilia- furniture and finishes The incorporation of biophilic elements in research and lab workplaces can add warmth, reduce stress, and enhance concentration, especially when access to nature is limited. In BSL3 and BSL4 labs where outdoor windows are prohibited, using nature-inspired colors on the walls and floors can help inspire a sense of calm akin to natural views, as can (if possi- ble) lighting that simulates natural daylight. Biophilic elements showcased in the workplaces' public areas are another effective design approach to counter-imposed design constraints. There is a requirement that all BSLs prohibit the inclusion of natural wood elements and plants because non-porous surfaces are susceptible to pathogens. Standing planters situated in the reception area at Halda Therapeutics focus traffic between two large structural beams, bringing in color and a welcoming biophilic element into the workplace. The integration of artwork and branding also creates an inviting atmosphere through appropriately placed color, signage, and furnishings. At EvolveImmune Therapeutics in Branford, CT, the integration of artful branding ties into the firm's "Biology First" brand through the smart and appro- priate use of color and materials in the office and BSL2 lab, including hexagon tiles and custom lighting fixtures in the shape of the company's logo. Additionally, special attention to furniture ergonomics and lighting not only maximize productivity but also worker enjoyment. At Halda, the workplace's lab is equipped with 40 wet bench- es outfitted with sinks and fume hoods. Thhere appropriate, the ceilings of lab areas are open and painted in a brand-in- spired blue accent color in order to add visual height to the room and reinforce the company's brand. Other brand-in- spired elements accent the 7,500-square-foot headquarters' workstations, meeting rooms, and huddle areas. Adding amenity spaces Amenity spaces provide a welcome relief from lab work and the opportunity to socialize and refuel with food and drink, an especially important design for scientists and researchers working in BSL2 labs and higher as they prohibit eating and drinking inside the labs. As is possible, a lab's easy proximity to shared eating areas, lounges, and meeting rooms can cre- ate a heightened connection with other team members, with the assurance that lab areas remain comfortable, clean, and productive workplaces that are safe from contaminants. Lab suites at Elm City Bioscience Center welcome interac- tions among colleagues with a variety of inviting amenity spaces that accommodate workspaces outside the secured labs, including offices, meeting rooms, and break rooms, with the option for multiple tenants to share these spaces. Inspiring and productive labs of all BSL ratings can be as safe and efficient as they are welcoming through designs based in team collaborations and innovative approaches to required elements and worker comfort. "The success of resulting labs is achieved through the design process. Often, a well-conceived and executed design solution is required to mitigate a potentially hazardous situation." SAFETY PRINCIPLES FOR HEALTHIER STAFF Staff health must be a priority- here are fundamental safety tips to keep in mind by Jonathan Klane, M S.Ed , C H, CSP, CHMM CIT Focus on health and hygiene overall Biosa ety is all about our biology, so focusing on our alth and hygi makes intuitive . Non-lab individuals e g , custodians and facilities need o be protect d as well. Additional y i your fetal protection plan up to date before worker repor s a pregnancy? Prevent exposures to fire, smoke, and toxic gases W at ste a e taken to minimize exposure? Educating st ff about the risks of being ove come from inhaling smoke or toxic ga lps them focus on tting out qui ly. Take all expo ur ser ous y and include follo up medica attention. Maintain healthy air quality in and out of the lab 22 Lab Manager Biosafety Resource Guide Fume hoods aren't 100 perc t effectiv -face velocity isn't the sole measu e of effective air control Other asses ments need to be done to ensure hoods are maintained and used properly.
Working with Biohazards Fundamentals of a comprehensive exposure control plan by Vince McLeod, CIH Thorking with human pathogens or biohazards poses serious risks, not only for employees, but for the public and com- munities as well. Infectious agents such as microorganisms, viruses, recombinant or synthetic nucleic acid molecules, and biological toxins present a potential for severe or lethal disease, adverse health effects, or contamination. Any un- planned exposure or release has the potential to cause exten- sive harm or damage to people, the environment, and society. The foundation for safe handling and research with infec- tious/biohazardous agents is an effective exposure control plan (ECP). This article discusses the basic elements of a comprehensive exposure control plan, what each element should address, and advice for successful implementation. The ECP is essentially a biohazard safety manual developed to address the unique conditions of the current research, facility design, and personnel operations necessary to carry out the laboratory's mission. One excellent free reference is the CDC's Biosafety in Microbiological and Biomedical Lab- oratories1 (BMBL), which contains comprehensive informa- tion on biological risk assessment and summary statements on many common infectious agents. An excellent ECP is comprehensive, clearly written, and well organized. A good companion to the BMBL is OSHA's model ECP contained in Appendix D of 29CFR1910.1030.2 However, effectiveness is ensured only when all persons who must enter or work in the containment areas are trained on and understand the key elements. ECP critical elements Your exposure control plan should contain main sections that address ECP administration, employee exposure deter- mination, implementation and control methods, and health and medical monitoring requirements, including appropri- ate pre-exposure prophylaxis, emergency procedures, and postexposure evaluation, employee training, and record keeping. Below we describe what each of these sections should address. ECP administration The opening section should provide a clear organization of personnel and assign responsibilities for implementation and support for the facility. The responsibilities of positions and/ or departments are outlined for maintaining, reviewing, and updating the ECP. In addition, responsibilities for maintain- ing and providing necessary personal protective equipment (PPE), engineering controls, and other infrastructure and equipment are contained here. Finally, responsibilities for medical actions, employee training, incident follow-up, and record keeping should also be listed. Employee exposure determination All employees who are determined to have potential occupa- tional exposure, and thus need to comply with the ECP, are defined in this section. Provide a list of all job classifications at the facility that have potential for exposures. Conduct job hazard analyses and exposure assessments where needed and as necessary. Implementation and control methods This section contains all the specific procedures for working safely. Everything from universal precautions to engineering controls to PPE is detailed and described. Specific laboratory layout and operations are also explained in this section. Con- trolling access is extremely important, and access should be restricted to only certified persons who are absolutely neces- sary. Certified means they understand the potential biohazard, "The foundation for safe handling and research with infectious/ biohazardous agents is an effective exposure control plan (ECP)." have demonstrated proficiency in the laboratory's procedures, and comply with the health and medical entry requirements. Proper entry and exiting procedures for staff, visitors, and maintenance/custodial workers are clearly established in this section. Included are security access mechanisms, such as self-closing, lockable doors, and other security measures. Proper signage indicating agents present, contact infor- mation for the principal investigator and other responsible persons, and any special requirements are posted at all access points. Engineering controls, such as interlocks and positive pres- sure airflow, and the means for checking they are properly functioning are spelled out in detail. The handling and dis- posal of sharps and other biohazardous waste are addressed. Ensure proper labeling is clearly described, including use of warning labels and red bags. PPE is one of the most important parts of the exposure control plan and discussed thoroughly in this section. The personal protective equipment that must be worn is listed for each position. Describe where PPE is stored as well as when and where it is used and how it is removed and discarded. This section should cover the proper types of gloves, eye- wear, and gowns or lab coats to be used. This section also addresses proper use and maintenance of the lab's safety equipment, such as autoclaves, biosafety cabinets, eyewash stations, safety showers, ventilation alarms, and other specially designed containment equipment. Proce- dures for decontaminating equipment prior to maintenance work should be included. The implementation and control section should address safe handling and storing of viable material, including biologi- cal safety cabinet use, handling frozen samples, and use of secondary containers. Procedures for housekeeping (e.g., cleaning up at the end of the day or after finishing a research protocol) are discussed, along with special instructions for laundry. Health and medical monitoring The purpose of this section is to provide another level of protection against laboratory-acquired illness, and it documents necessary immunizations. Immune-suppressed individuals or persons at increased risk should be strongly discouraged from entering the facility. Depending on the agents present, vaccinations (hepatitis B), antibody testing (TB skin test), or serum storage may be required. The ECP should clearly define what is required and who is covered, with well-documented rationale. Emergency procedures This section describes procedures for an accident, exposure incident, or spill or release that injures laboratory staff or contaminates the environment. A good reference for putting this section together is OSHA's bloodborne pathogens stan- dard, 29CFR1910.1030.3 Follow initial first aid procedures and document the routes of exposure and how it occurred. Ensure spill kits are available and biohazard spills decontam- inated and cleaned up as soon as possible by properly trained and equipped staff. Any incident should be completely docu- mented with a written report, and a postexposure evaluation and follow-up should be performed. Employee training and incident reporting The final section of a comprehensive exposure control plan covers employee training and record keeping. First, ensure everyone who will be working in the containment facili- ty has been trained on and understands the ECP. Inform employees about each infectious agent present, the risks associated with these agents, and the signs and symptoms of infection or disease. Make sure procedures for identifying, reporting, and correcting exposures, incidents, near misses, or violations of protocol are covered in detail. Finally, the training should be renewed annually, and written documen- tation should be kept on file. References:
Preparing for a Health and Safety Compliance Audit A step-by-step guide for the safety audit process and how to be prepared by Vince McLeod, CIH This article intends to prepare the lab manager for a health and safety audit. The basic Occupational Safety and Health Administration (OSHA) regulations and programs will be covered, addressing recognized hazards in the typical research lab. Thith these tips, lab leaders can better identify and minimize the most common hazards associated with running a busy research laboratory. Always provide a safe work environment The OSHA requirement that employers provide a work- place "free from recognized hazards" is the foremost tenet of worker safety. This is known as the "general duty clause," Section 5(a)(1) of the OSH Act, which covers all recognizable hazards, especially those for which specific standards may not exist. Examples of the latter include ergonomic issues and exposures to anesthetic gases or experimental drugs, among others. Many specific OSHA standards apply to research laborato- ries. The two most notable within 29 CFR are the occupa- tional exposure to hazardous chemicals in laboratories, also known as the OSHA Lab Standard (1910.1450), and hazard communication (1910.1200). Other standards that might apply include respiratory protection (1910.134), electrical and fire safety, and those dealing with certain toxic and danger- ous chemicals such as benzene, methylene chloride, etc. Entrance and pre-audit conference Thhen first approaching any area that may contain hazards, lab professionals should recognize that the room they are about to enter is different. It is not an office. There are things that set this area apart and have the potential to harm or in- jure. So, all entrances should have complete and proper sig- nage to alert anyone planning to enter to the hazards within. Signs should indicate if chemical hazards are present-and if so, what type. Corrosive, toxic, flammable, carcinogenic, and other signs, as appropriate, should be posted on or near the entrance door. Also, be sure to include emergency contact information and names and phone numbers for the principal investigator (PI) and laboratory manager, at a minimum. Upon entry, most auditors will ask to see the lab's chemi- cal inventory, chemical hygiene plan (CHP), and standard operation procedures (SOPs). Training records and source(s) of safety data sheets (SDS) may also be requested. After perusing the inventory and SOPs, the auditor, especially if unfamiliar with the lab, might ask for a brief tour and de- scription of the basic lab operations and work areas. The survey or walk-about Following the pre-audit conference, the auditor will begin the health and safety survey, or walk-about. Protecting worker health and safety begins with recognizing workplace hazards. Generally, these fall into three main categories: chemical, biological, or physical. Examples of chemical hazards include corrosive chemicals, solvents, cleaning agents and disinfectants, drugs, anesthetic gases, paints, and compressed gases. Potential exposures to chemical hazards can occur during handling, use, transport, or storage. Biological hazards are usually limited to specialty labs and include potential exposures to allergens, zoonotic diseases (animal diseases transmissible to humans), and experimental agents such as viral vectors. Allergens, ubiquitous in animal research facilities, are one of the most common, yet fre- quently overlooked, health hazards. Physical hazards are always present in laboratories and research facilities. The most obvious are slips and falls from working in wet locations and the ergonomic hazards of lifting, pushing, pulling, and repetitive tasks. Other physical hazards that are often unnoticed include electrical, mechani- cal, acoustic, or thermal hazards. Focusing on the most common hazards The number one hazard in labs-chemical misuse or mis- handling-provides the potential for considerable harm or injury. Auditors will usually zero in on areas of chemical use and storage. To avoid problems, be sure to have and imple- ment a robust chemical control and handling program. The OSHA standard that helps mitigate these potential problems is the Hazard Communication Standard, which "The number one hazard in labs- chemical misuse or mishandling- provides the potential for considerable harm or injury." deals with employers' requirements to inform and train em- ployees on the use of chemicals. In addition, the OSHA Lab Standard, 29 CFR 1910.1450, requires laboratories to identify hazards, determine employee exposures, and develop a CHP. The "lab standard" mandates written SOPs addressing the particular hazards and precautions required for safe use. Both standards require maintaining SDS and providing employee training. Number two on most auditors' lists would cover physical hazards. The inherent physical hazards present include electrical safety hazards, ergonomic hazards associated with manual material handling and equipment use, handling sharps, and basic housekeeping issues. Check for proper usage of extension cords and an easily accessible and well-labeled circuit breaker panel, for starters. Equip all electrical power outlets in wet locations (outlets within six feet of a sink, faucet, or other water source) with ground fault circuit interrupters, or GFCIs, to prevent ac- cidental electrocutions. Do not substitute flexible extension cords for permanent wiring. Ensure all cord insulation is in good condition without cracks, breaks, cuts, or tears. Take care to not run extension cords through doors or windows, where they can become pinched or cut. Use only grounded equipment and tools with grounding pins present, and always be aware of potential tripping hazards when using them. Review all laboratory operations that necessitate workers performing sustained or repetitive motions. Conduct an er- gonomic work survey, and ensure a neutral, balanced posture for these tasks. Use only puncture-proof and leak-proof sharps containers that are clearly labeled. Train employees never to remove the covers or attempt to transfer the contents. Make sure they get replaced when three-fourths full to prevent overfilling. Finally, do not overlook general housekeeping. Slips, trips, and falls are very common, yet easily avoided with safe and organized storage areas. Store materials in tiers stacked, blocked, interlocked, and limited in height so that they are stable and secure against falling or collapse. Specialty biological labs entail hazards with infectious microbes, recombinant organisms, and viral vectors. Much of the work with recombinant DNA, acute toxins, and select agents is now regulated by federal agencies such as the US Department of Agriculture, the Department of Home- land Security, and the Department of Health and Human Services, including the National Institutes of Health. If your facility is conducting research in these areas, you should have an institutional biosafety committee to keep everything in order and running smoothly. The most prevalent biological hazard, in terms of frequency of occurrence, is exposure to allergens associated with the use and care of laboratory animals. Health surveys of people working with laboratory animals show that up to 56 percent are affected by animal-related allergies. Health and safety issues should address containment, the ability for replication, and potential biological effect. Post-audit conference The health and safety audit should usually end with a post-audit conference. The auditor reviews all issues with the PI or manager and discusses appropriate corrective actions and a timeline for completion. A written summary is transmitted shortly after the visit and should include the agreed upon corrections and completion dates. A follow-up visit should be performed to ensure corrective actions are finished. Research laboratories present many health and safety chal- lenges. However, with proper guidance, a trained eye, and practice in conducting in-house audits, laboratory leaders can find and correct many common mistakes and prevent illness or injury. Baker has been at the forefront of engineering, testing and production of reliable laboratory contamination control equipment since 1951 when Baker designed and built the first clean air workstation. Since then, we have maintained an unparalleled passion for helping our customers advance science, discovery, and clinical care, by taking no chances with customers' safety and making no compromises when it comes to protecting your research. Baker's products are built to order with precision craftsmanship and designed for your unique application need. Our rigorous testing protocols go above and beyond what the average user would ever encounter, and our quality control measures exceed industry standards. Our commitment to sustainable business practices and the development of a new generation of energy efficient products ensures that you - and your budget - will be pleased
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