Laboratory Biosafety Level Criteria-Biosafety Level 2 ria brary.administraiv o).All institu tion:it s hould never be taken hom e by pe rson nel 4. 8。 gloves are not w re or used and they should not be worn outside the b.Alternatives .Hands are wash D.Laboratory Faciities (Secondary Barriers) Provide lockable doors for facilties that house restricted agents(as defined in 42 CFR 72.6). Consider locating new laboratories away from public areas 3. Each laboratory contains a sink for handwashing 5. Bench are vious to wat and are resis and chemicals used to decontaminate the work surfaces and equipmen 6. Laboratory furniture is capable of supporting anticipated loading and Spaces and equipment are access cleaning 26
Laboratory Biosafety Level Criteria – Biosafety Level 2 26 This protective clothing is removed and left in the laboratory before leaving for non-laboratory areas (e.g., cafeteria, library, administrative offices). All protective clothing is either disposed of in the laboratory or laundered by the institu tion; it s hould nev er be take n hom e by pe rson nel. 4. Glov es ar e worn wh en ha nds ma y contact poten tially infectious materials, contaminated surfaces or equipmen t. We aring two p airs of glov es m ay be app ropriate. Gloves are disposed of when overtly contaminated, and rem oved w hen wo rk with infe ctious m aterials is co mple ted or wh en the integ rity of the glove is com prom ised. Disposable gloves are not washed, reused, or used for touching “clean” surfaces (keyboard s, telephones, etc.), and they should not be worn outside the lab. Alternatives to powdered latex gloves should be ava ilable. Hands are washed following removal of gloves. D. Laboratory Facilities (Secondary Barriers) 1. Provide lockable doors for facilities that house restricted agents (as defined in 42 CFR 72.6). 2. Con sider loca ting new labora tories away from public areas. 3. Each la boratory c ontains a sink for h andwa shing. 4. The labor atory is desig ned so that it ca n be e asily cleaned. Carpets and rugs in laboratories are inappropriate. 5. Bench tops are imper vious to w ater and are resis tant to moderate heat and the organic solvents, acids, alkalis, and chemicals used to decontaminate the work surfaces and eq uipm ent. 6. Laboratory furniture is capable of supporting anticipated loading and uses. Spaces between benches, cabinets, and equipment are accessible for cleaning. Chairs and
fetyLevel Criteria-Biosafety Level 3 other furnt decontaminated ner tha fluctuations of the room supply and exhaust air do not cause the biolgical safety cabnets to operae outside safety capnets away frm doors.from windows that can be opened,from heaviy traveled laboratory areas,and hanainerh2b078 parameters for containm ent An eyewash station is readily available 9 10. sulation to spaces outside of the laboratory are that open to the exterio ree Biosafety Level 3(BSL-3) Biosafety Level 3 is applicable to clinical diagnostic. teaching.research.or roduction facilities in which work is done ase as n may ca ut of route.Laboratory personnel have specfic training n handling agents. agents. materialgaercodueenuiihbb8glea8aetycane6oroiney All procedures physical contain me nt devices,or by personnel wearing appro pri 27
Laboratory Biosafety Level Criteria – Biosafety Level 3 27 other furniture used in laboratory work should be cove red w ith a no n-fabric m ateria l that c an be easily decontaminated. 7. Install biological safety cabinets in such a manner that fluctuations of the room supply and exhaust air do not cause the biological safety cabinets to operate outside their parameters for containment. Locate biological safety cabinets away from doors, from windows that can be opened, from heavily traveled laboratory areas, and from other po tentially disruptive e quipm ent so as to maintain the biological safety cabinets’ air flow param eters for containm ent. 8. An eyew ash sta tion is readily ava ilable. 9. Illumination is adequate for all activities, avoiding reflections and glare that could imped e vision. 10. There are no spe cific ventilation requirements. Ho wever, planning of new facilities should consider mechanical ventila tion s ystem s that prov ide an inward flow of air without rec irculation to s paces outside o f the labora tory. If the laboratory has windows that open to the exterior, they are fitted with fly screens. Biosafety Level 3 (BSL-3) Biosa fety Lev el 3 is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation route. Laboratory personnel have specific training in handling pathogenic and potentially lethal agents, and are supervised by competent scientists who are experienced in working with these agents. All procedures involving the manipulation of infectious materials are conducted within biological safety cabinets or other phys ical co ntainme nt devices , or by p erso nnel wearing a ppro pri-
Laboratory Biosafety Level Criteria-Biosafety Level 3 uipment.The laboratory It is reco er that some existing facilitie maynothae9meZael9Yarasaemesaoag1oseiety propagation of an agent for identification,typing,susceptibility testing)may be achie ved in a B afety Level 2 fa ility, d tothe outdoors.2)the is recommended Standard Microbiobgical Practices.Special Practices and Safety Equipment for Biosafety Level 3 are the laboratory director. The foll standaro A.Standard Microbiological Practices s to the lab are in progress. Persons wash their hands after handing Eating.drinking,smoking,handling contact lenses,and perm d in the lab orato ry d also wear gogales or a face shield Food is stored out. orkncabintorr r this pur pose only. 28
Laboratory Biosafety Level Criteria – Biosafety Level 3 28 ate personal protective clothing and equipmen t. The laboratory has sp ecial eng ineering a nd des ign feature s. It is recognized, however, that some existing facilities may no t have all the fa cility features re com men ded for Biosafety Level 3 (i.e., do uble-do or acce ss zone and se aled pen etrations). In this circumstance, an acceptable level of safety for the conduct of routine procedures, (e.g., diagnostic procedures involving the propag ation of an agent fo r identification, typin g, susc eptibility testin g, etc .), m ay be a chieved in a Bios afety L evel 2 facility, providing 1) the exha ust air from the lab orato ry room is discharg ed to the ou tdoo rs, 2) the ve ntilatio n to th e labo rator y is balance d to provide directiona l airflow into the ro om, 3 ) acces s to the laboratory is restricted when work is in progress, and 4) the recommended Standard Microbiological Practices, Special Practices, and Safety Equipme nt for Biosafety Level 3 are rigorously followed. The decision to implement this modification of Biosafety Level 3 recommendations should be made only by the laboratory director. The following standard and special safety practices, equipm ent and f acilities apply to ag ents as signed to Biosafe ty Level 3: A. Standard Microbiological Practices 1. Access to the laboratory is limited or restricted at the discretion of the labo ratory directo r when e xperim ents are in progress. 2. Persons wash their hands after handling infectious materials, after removing gloves, and when they leave the labor atory. 3. Eating, drinking, smoking, handling contact lenses, and applying co sm etics are n ot permitted in the lab orato ry. Pers ons who wear con tact le nses in lab orato ries s hould also wea r goggles or a face shield. Foo d is stored outside the work area in cabinets or refrigerators designated for this pur pose o nly
Laboratory Biosafety Level Criteria -Biosafety Level 3 4. 5. Policies for the safe handling of sharps are instituted. 6. All procedures are perfomed carefully to minimize the creation of aerosols. Work surfaces are decontaminated at least once a day and after any spill of viable material. All cultures stocks and other regulated wastes are deconta minated before disposal by an approved decon tamination me tenals to b placed in adurable eakproof container and closed or removal for off-site dispo sal. 9. Apei8c8ndodentcontrolprogramisineiect(see B.Special Practces 1. Laboratory doors are kept closed when experiments are in progress The laboratory director controls access to the laboratory and restricts access to persons whose presence is re are at increased risk of acquiring infectin or for whom infection may have serious consequences are not suppressed may be at risk of cquiring infections.The the laboratory.No minors should be allowed in the labor atory. 29
Laboratory Biosafety Level Criteria – Biosafety Level 3 29 4. Mouth pipetting is prohibited; mechanical pipetting devices are u sed. 5. Policies for the safe handling of sharps are instituted. 6. All procedures are performed carefully to minimize the creation of aerosols. 7. Work surfaces are decontaminated at least once a day and after any sp ill of viab le m ateria l. 8. All cultures, stocks, and other regulated wastes are decontaminated before disposal by an approved decontamination method, such as autoclaving. Materials to be decontam inated outside of the imme diate laboratory are placed in a durable, leakproof container and closed for transport from the laboratory. Infectious waste from BSL-3 laboratories should be deco ntaminated before rem oval for off-site dispo sal. 9. An insect and rodent control program is in effect (see Appendix G). B. Special Practices 1. Laboratory doors are kept closed w hen experime nts are in progress. 2. The laboratory director controls access to the laboratory and restricts access to persons whose presence is required for program or support purposes. Persons who are at increased risk of acquiring infection or for whom infection may have serious consequences are not allowed in the laboratory or animal rooms. For example, persons who are immunocom promised or immunosuppressed may be at risk of acquiring infections. The director has the final responsibility for assessing each circum stan ce an d determ ining w ho m ay enter or w ork in the laboratory. No minors should be allowed in the labor atory
Laboratory Biosafety Level Criteria-Biosafety Level 3 3 all eny and exit procedures.enter the bpratory or with animal rooms. ating the rsal bi hazard sym doors.The hazard warning sign identifies the agent.lists and telep e numbe tory drec h special requirements for entering the laboratory.such as the need for mmunizations. eas80iegesptators.orouha 5. muniza ent in the ag rato ine or k testing).and period c testing as recommended for the agent being nandle 6. Baseline serum samples are collected as appropriate for all laboratory and other at-risk p rson ne collected.depending on the agents handed or the function of the la bora tory. A biosafety manual specific to the aboratory is prepared or adopted by the laboratory director and b safety and are required to read and follow nstructionson practices and procedures 8. Laboratory and support personnel receive appropriate ntial hazard associated with the work necessary prec ent expo 30
Laboratory Biosafety Level Criteria – Biosafety Level 3 30 3. The laboratory director establishes policies and procedures whereby only persons who have been advised of the potential biohazard, who meet any specific entry requirem ents (e.g ., imm unization), an d who c omp ly with all entry and exit procedures, enter the laboratory or animal rooms. 4. When infectious materials or infected animals are present in the laboratory or containment module, a hazard warn ing sig n, incorpo rating the univer sal bio haza rd sym - bol, is posted on all laboratory and animal room access doors. T he haza rd warn ing sign ide ntifies the ag ent, lists the name and telephone number of the laboratory director or other responsible person(s), and indicates any special requirements for entering the laboratory, such as the need for immunizations, respirators, or other personal protective measures. 5. Laboratory personnel receive the appropriate immunizations or tests for the agents handled or potentially present in the lab orato ry (e.g ., hep atitis B vacc ine or TB s kin testing), and periodic testing as recommended for the agent being handled. 6. Baseline serum sam ples are c ollected as approp riate and sto red for all labo ratory and other at-risk person nel. Add itional seru m s pec ime ns m ay be p eriod ically collected, depending on the agents handled or the func tion of the la bora tory. 7. A biosafety manual specific to the laboratory is prepared or adop ted by the lab oratory direc tor and b iosafety precautions are incorporated into standard operating procedures. Personnel are advised of special hazards and are required to read and follow instructions on practice s and p rocedu res. 8. Labora tory and su pport pe rsonne l receive ap propriate training on the potential hazards associated with the work involved, the necessary precautions to prevent expo-