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USF
Research Integrity & Compliance
Biosafety Level 3 Inspection Form
PRINCIPAL INVESTIGATOR: INSPECTION DATE:
BUILDING/ROOM:
INSPECTOR(S): LAB GUIDE(S):
Biosafety Level 3 Yes No N/A Comments
A. Standard Microbiological Practices
1. Institutional policies being enforced that control
access to the laboratory.
2. Persons wash hands after work w/cultures &
removing gloves, before leaving lab.
3. Eating, drinking, storing food, etc. prohibited.
4. Mouth pipetting prohibited; pipettors used.
5a. Sharps policies in place.
5b. Sharps disposed in biohazardous Sharps
containers.
5c. Broken glassware is only handled by
mechanical means.
5d. Plastic ware is substituted for glassware
whenever possible.
5e. Disposable needles are not bent, sheared,
broken, recapped, removed from disposable
syringes, or otherwise manipulated prior to
disposal.
5f. Syringes that “re-sheath” the needle or
needleless systems are used when appropriate.
6. Splashes & aerosols are minimized.
7a. Work surfaces disinfected after completion of
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work and after any spill, disinfectants effective.
7b. Biohazard spill cleanup kit available.
8. Waste decontaminated and disposed in effective
manner.
A method for decontaminating all laboratory
wastes should be available in the facility,
preferably within the laboratory suite (e.g.,
autoclave, chemical disinfection)
9. A biohazard sign, PI/Emergency contact
information, biosafety level, and required
procedures for entering and exiting the laboratory
are posted on entry doors to lab.
10. An effective integrated pest management
program is required.
11a. PI ensures personnel receive appropriate
training.
11b. Personnel must receive annual updates and
additional training when procedural or policy
changes occur.
11c. All laboratory personnel and particularly
women of child-bearing age should be provided
with information regarding immune competence
and conditions that may predispose them to
infection.
11d. Individuals having these conditions should be
encouraged to self-identify to the institution's
healthcare provider for appropriate counseling and
guidance.
B. Special Practices: Yes No N/A Comments
1. Laboratory staff is advised of potential hazards.
2. Laboratory staff is provided medical surveillance
and appropriate immunizations if applicable.
3. Policy in place regarding baseline serum for at
risk personnel, as appropriate.
4a. A laboratory-specific biosafety manual must be
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prepared and adopted as policy.
4b. The biosafety manual must be available and
accessible.
5. The PI must ensure that laboratory staff
demonstrates proficiency in standard and special
microbiological practices prior to work with BSL-3
agents.
6. Infectious agents must be placed in a durable,
leak proof container during collection, handling,
storage and transport.
7a. Laboratory equipment decontaminated
routinely, after spills, before repair, maintenance,
or removal from lab.
Spills involving infectious materials must be
contained, decontaminated, and cleaned up by
staff properly trained and equipped to work with
infectious material.
8a. Incidents that may result in exposure to
infectious materials must be immediately evaluated
and treated according to polices.
8b. All such incidents must be reported to the
laboratory supervisor and biosafety officer.
8c. Medical evaluation, surveillance, and treatment
should be provided and appropriate records
maintained.
9. Animals & plants not involved in work not
permitted in lab.
10a. Open manipulation w/ agents in BSC and or
other containment devices. No work with agents
on open bench.
10b. When a procedure cannot be performed
within a BSC, a combination of personal protective
equipment and other containment devices, such as
a centrifuge safety cup or sealed rotor, must be
used.
11. Equipment and storage areas for use with
biohazard are properly labeled. Agents are
properly labeled.
C. Safety Equipment (Primary Barriers) Yes No N/A Comments
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1. All procedures conducted in BioSafety Cabinet
(BSC). BSC is certified annually.
2a. Protective laboratory clothing with a solid-front
such as tie-back or wraparound gowns, scrub suits,
or coveralls are worn by workers when in the
laboratory
2b. Lab coats/gowns worn & not removed from
lab.
2c. Reusable clothing decontaminated before
laundering.
2d. Clothing is changed when contaminated
2e. Gloves worn when handling agents, animals or
equipment.
3a. Eye and Face protection is used for anticipated
splashes or sprays of infectious agent.
3b.Eye wear must be disposed when contaminate
with other lab waste or decontaminated prior to
reuse
4a. Gloves worn when handling agent, animals, or
equipment. Change gloves frequently,
accompanied by handwashing.
4b. Gloves must not be worn outside the
laboratory in non-lab areas.
4c. Change gloves when contaminated or integrity
compromised.
4d. Do not wash or reuse disposable gloves.
4e. BSL-3 laboratory workers should: Wear two
pairs of gloves when appropriate.
5. Eye, face and respiratory protection should be
used in rooms containing infected animals.
D. Laboratory Facilities (Secondary Barriers) Yes No N/A Comments
1a. Laboratory doors must be self closing and have
locks in accordance with the institutional policies.
1b. The laboratory must be separated from areas
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that are open to unrestricted traffic flow within the
building.
1c. Access to the laboratory is restricted to entry
by a series of two self-closing doors.
1d. A clothing change room (anteroom) may be
included in the passageway between the two self-
closing doors.
2. Each lab room contains hand-free handwashing
sink located near exit door.
3a. Lab must be designed so that it can be cleaned
and decontaminated.
3b. Carpet and rugs not permitted. Surfaces
cleanable (walls, floors, ceiling).
3c. Seams & penetrations sealed.
3d. Walls and ceiling sealed smooth finish for easy
cleaning and decontamination.
3e. Floor slip resistant.
3f. Spaces around doors and ventilation openings
should be capable of being sealed to facilitate
space decontamination.
4a. Lab furniture is appropriate for loading and
use.
4b. Spaces between cabinet, benches and
equipment accessible for cleaning.
4c. Benchtops impervious to water and resistant to
chemicals.
4d. Chairs used in laboratory covered with a non-
porous material.
5. All windows in the laboratory must be sealed.
6. BSCs located away from doors, heavily traveled
areas, etc, to maintain airflow pattern.
7a. Vacuum lines protected by HEPA filters or
equivalent.
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7b. Filters must be replaced as necessary
8. Eyewash readily available inside lab.
9a. A ducted air ventilation system is required.
Negative pressure airflow into laboratory. Under
failure conditions the airflow will not be reversed.
The laboratory exhaust air must not re-circulate to
any other area of the building. The laboratory
building exhaust air should be dispersed away from
occupied areas or exhaust must be HEPA filter.
9b. Laboratory personnel must be able to verify
directional air flow. A visual monitoring device
which confirms directional air flow must be
provided at the laboratory entry.
9c. Audible alarms should be considered to notify
personnel of air flow disruption
10a. HEPA filtered exhaust air from a Class II BSC
can be safely re-circulated into the laboratory
environment if the cabinet is tested and certified at
least annually and operated according to
manufacturer's recommendations. BSCs can also
be connected to the laboratory exhaust system by
either a thimble (canopy)connection or a direct
(hard) connection.
10b. Provisions to assure proper safety cabinet
performance and air system operation
must be verified
10c. BSCs should be certified at least annually to
assure correct performance.
11. A method of decontaminating all laboratory
waste should be available preferably within the
laboratory. If contaminated waste leave lab, they
are sealed & not transported in public corridor.
Large pieces of equipment should be
decontaminated before removal from the
laboratory.
12. Aerosol producing equipment (e.g., continuous
flow centrifuges) are contained in devices that
exhaust through HEPA filters. These HEPA filters
should be tested annually.
13a. Facility design consideration should be given
to means of decontaminating large pieces of
equipment before removal from the laboratory.
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13 b. Enhanced environmental and personal
protection may be required by the agent summary
statement, risk assessment, or applicable local,
state, or federal regulations. These laboratory
enhancements may include, for example, one or
more of the following; an anteroom for clean
storage of equipment and supplies with dress-in,
shower-out capabilities; gas tight dampers to
facilitate laboratory isolation; final HEPA filtration
of the laboratory exhaust air; laboratory effluent
decontamination; and advanced access control
devices such as biometrics. HEPA filter housings
should have gas-tight isolation dampers;
decontamination ports; and/or bag-in/bag-out
(With appropriate decontamination procedures)
capability.
13c. The HEPA filter housing should allow for leak
testing of each filter and assembly. The filters and
the housing should be certified at least annually
14. BSL3 facility & operational procedures
documented. Facility tested for verification prior to
operation. Facilities re-verified, at least annually
against these procedures.
15. Illumination is adequate, avoiding glares and
reflections that could impede vision.
16. Autoclaving procedures verified. If yes, explain
how.
E. Institutional Biosafety Committee Yes No N/A Comments
1. IBC review and approval of agent(s).
2. Changes/modifications reported to IBC.
3. USF Biosafety training for all staff in date.
4. If Shipping biohazardous agents, appropriate
DOT/IATA training completed and applicable
permits in place.
BIOSAFETY CHECKLIST: Reference: CDC BMBL 5th Edition
Deficiencies: For BSL-2, per the BMBL:
Risk Assessment/Recommendations:
Comments:
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Date ___________ Signature of Inspector________________________________
Date __________ Reviewed by _______________________ Title ________________
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