Download (SOP) Development Guidance Template

LABORATORY
STANDARD OPERATING PROCEDURE
DEVELOPMENT GUIDANCE TEMPLATE
Please edit and complete as necessary to address Biosafety Risks
within your laboratory
Date:
Principal Investigator:
Department:
Room(s) + BSL of each room:
Phone:
______________________________________________________________________________
1. Access to the laboratory is limited to staff, or other persons with permission of the
Principal Investigator, when work with BSL-2 pathogens is being conducted. Access is
limited according to attached procedures.
2. All laboratory personnel must be screened by Employee Health before working with
potentially infectious materials, including fresh, unfixed, human or non-human primate
specimens, uncharacterized cell lines, etc. Any available vaccinations which would
reduce the risks associated with exposure to any of the agents in the protocol must be
offered to all personnel or a signed waiver must be obtained by the PI.
3. Persons who are increased risk of infection, or for whom infection may have serious
consequences, must not be allowed to enter laboratory when work with infectious agents
are in progress without permission of the Principal Investigator.
4. All persons entering the laboratory must be advised of potential hazards. Laboratory
workers must be trained and made aware of the hazards and appropriate safety
precautions before working with any of the biological agents.
5. Spills and accidents that result in overt exposures to infectious materials must be
immediately reported to the Principal Investigator and appropriate medical evaluation
must be provided.
6. Laboratory staff must not eat, drink, smoke, handle contact lenses, chew gum, apply
cosmetics in laboratory.
7. Food or drink for human consumption or utensils or cups must stored outside laboratory
work area in refrigerators designated for that purpose only.
8. Laboratory staff and all other persons working with infectious substances must wear
gloves. Contaminated gloves must be changed IMMEDIATELY. Under NO
CIRCUMSTANCES will gloves be reused.
Application Date: _______________
101206
Principal
1 Investigator: ___________________________________________
9. Laboratory staff must wash hands after handling infectious materials, after removing
gloves, and before leaving the laboratory.
10. Face protection (goggles, mask, face shield, or other splatter guard) must be used for all
procedures when such procedures could produce splashes or sprays of infectious or other
hazardous materials or when microorganisms are manipulated outside the biological
safety cabinet. See attached procedures for more detailed PPE requirements.
11. Protective clothing must be removed and left in laboratory before going to non-laboratory
areas (cafeteria, library, administrative areas).
12. Protective clothing must be either disposed of in laboratory or laundered by institution.
(NEVER taken home!)
13. Only mechanical pipetting devices must be used in the laboratory.
14. All sharps must be placed in red (approved) sharps containers.
15. Sharps containers must be turned in when ¾ full.
16. All procedures must be performed to minimize creation of splashes or aerosols according
to attached procedures.
17. A Biosafety Cabinet must be used for all procedures with potential for creating infectious
aerosols or splashes, or whenever handling high concentrations of infectious materials.
18. Biological Safety Cabinet must have a current (annual) certification.
19. Biological Safety Cabinet must not be used until it is recertified after relocation, any
movement, or dislocation.
20. Centrifuges used for high concentrations or large volumes of infectious agents must have
sealed rotor heads or centrifuge safety cups. Safety cups must be opened only in a
Biosafety cabinet.
21. All infectious animal carcasses must be disposed of by placing in a plastic bag and
placing in infected animal carcass freezer or according to attached procedures.
22. All non-liquid contaminated cultures, stocks, plasticware and other biologically
contaminated waste must be disinfected and placed in biomedical waste containers for
disposal according to attached procedures.
23. All infectious liquids must be decontaminated or disinfected prior to being poured into
drain according to attached procedures.
24. All work surfaces must be decontaminated at the completion of work, at the end of the
day, or after any spill or splash of viable material according to attached procedures.
25. Laboratory equipment, surfaces and other contaminated materials must be
decontaminated with an effective disinfectant on a routine basis, after work with
infectious materials is finished, and especially after overt spills, splashes, or other
contamination according to attached procedures. Equipment must be decontaminated
before removal from the laboratory (for repair maintenance or other purposes).
Decontamination protocol is attached.
26. Laboratory doors must be locked when the laboratory is not occupied.
Application Date: _______________
101206
Principal
2 Investigator: ___________________________________________
27. Spaces between benches, cabinets, and equipment must be kept accessible for cleaning.
28. Eyewash must be flushed at least monthly and kept clear of obstructions.
29. All personnel must know the location of the nearest safety shower and must ensure that
area under the shower is kept free of obstructions.
30. Any personnel with overt exposure will be taken to Employee Health and/or the ER for
immediate (<1 hour) post-exposure medical intervention and monitoring.
31. Any overt exposures of personnel to biological agents will be reported to the PI and the
BSO as soon as possible.
Application Date: _______________
101206
Principal
3 Investigator: ___________________________________________
SOP ADDENUM- DETAILED LABORATORY-SPECIFIC PROTOCOLS
1. Storage and access control of cells or cultures include the following. Consider storage in all locations, including freezers, cryotanks, cold
rooms.
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
2.
No
No
No
No
No
No
No
No
No
Agents are stored inside well-labeled tubes/vials.
Agents are stored inside well-labeled storage boxes.
Biohazard labels are clearly affixed on any storage device clearly identifying the hazards inside
Storage refrigerators/freezers/cryotanks are in rooms whose access is limited to authorized personnel.
Refrigerators are kept locked and accessible only to authorized personnel
Freezers are kept locked and accessible only to authorized personnel
Cryotanks are kept locked and accessed only by authorized personnel
Lockboxes are utilized and accessible only to authorized personnel
Policies and procedures are in place whereby only persons who have been advised of the potential hazard and meet any
specific entry requirements (e.g., immunization) are authorized to enter the laboratory or have access to agents.
No Others (please specify)
Procedures employed which may result in the generation of aerosols, splashes and/or sprays of biological material and safety precautions
that should be followed by personnel performing these procedures are as follows:
Centrifugation
Sonication
Vortexing
Homogenization
Opening Vacuum vials
Syringe filtration
Placing biological materials under pressure (through small bore hoses or needles)
Animal cage changing
Intranasal inoculation
Necropsy of infected animals
Fluorescence activated cell sorting
Fluorescence activated cell analysis
Other (please specify):
Safety precautions (e.g. use of Biosafety Cabinets, shields, respirators, containment devices):
3. Transport procedures for transport of agent(s)* between locations (i.e. through hallways and other non-laboratory areas). Note: For BSL2
agents, consider transporting agents inside a sealed, leakproof primary container inside a well-labeled sealed, leakproof, durable secondary
container.
*If transporting animals, please describe procedure.
*If transporting any biological agent off-campus, please refer to Biosafety Schedule L for transport guidelines.
Application Date: _______________
101206
Principal
4 Investigator: ___________________________________________
4. Disinfection/decontamination and disposal of viable agents or recombinant DNA or items which have come in contact with these agents.
See: http://www.mcg.edu/research/ibc/disinfectants for guidance in selecting appropriate disinfectants for the agents in this protocol.
LIQUID WASTES (check all that apply):
Disinfection/Decontamination Method
None necessary
Autoclaving
Chemical Methods:
Bleach (freshly diluted to final 10% (v/v))
Other chlorine products (Clidox®)
Iodine/iodophors (eg. Wescodyne®)
Alcohols (e.g. final 70% (v/v) EtOH or IPA)
Phenolic agents (e.g. Biozide®, Vesphene®)
Quaternary Ammonium Agents (e.g. Roccal®,
Coverage Plus®, Cavicide®, Lysol®)
Aldehydes (e.g. 2-4% glutaraldehyde, 4%
formaldehyde, Cidex®)
Peroxygens (e.g. Virkon®)
Treatment
time (eg. 30
min)
N/A
Final Disposal (after disinfection indicated in left column))
Check all that apply. If “other”, please specify below
Into Sewer
In sharps container
In sharps container
As chemical waste
As chemical waste
Other
Other
Into Sewer
In sharps container
As chemical waste
As chemical waste
As chemical waste
As chemical waste
As chemical waste
As chemical waste
Other
Other
Other
Other
Other
Other
As chemical waste
Other
As chemical waste
Other
Other, please specify:
SOLID WASTES (Plasticware, glassware, tubes, tissues) (check all that apply):
Disinfection/Decontamination Method
None required
Autoclaving
Chemical Methods
Bleach (freshly diluted to final 10% (v/v))
Aldehydes (e.g. fixation with 2-4%
glutaraldehyde, 4% formaldehyde)
Peroxygens (e.g. Virkon®)
Treatment
time (eg. 30
min)
N/A
Final Disposal (after disinfection indicated in left column)
Check all that apply. If “other”, please specify below
All biological waste must be disposed as Biohazardous Waste
In Biohaz. box
In Biohaz. box
In biohaz. sharps container
In biohaz. sharps container
Other
Other
In Biohaz. box
In Biohaz. box
In biohaz. sharps container
In biohaz. sharps container
Other
Other
In Biohaz. box
In biohaz. sharps container
Other
Other, please specify:
ANIMAL TISSUES/CARCASS WASTE (check all that apply):
Disinfection/Decontamination Method
Autoclaving prior to removal from laboratory
None, transported to LAS as per protocol below
Treatment
time (eg. 30
min)
N/A
Final Disposal (after disinfection indicated in left column)
Check all that apply. If “other”, please specify below
In LAS animal disposal freezer
In LAS animal disposal freezer
In Biohaz. waste box
In Biohaz. waste box
Other, please specify:
Application Date: _______________
101206
Principal
5 Investigator: ___________________________________________
Other
Other
5.
Work surfaces, instruments, equipment will be decontaminated using the following method(s). Consider both benchtop surfaces and
stainless steel surfaces (such as those in biosafety cabinets), as well as in equipment (such as centrifuges) and instruments (check all that
apply):
Disinfection/Decontamination Method
Contact time
(e.g. 30’)
Frequency
(e.g. daily and after
spills)
Benchtops
Check all that apply
Stainless Equipment
Surfaces
Autoclaving
Chemical Methods:
Bleach (freshly diluted to final 10%
(v/v))
Bleach (freshly diluted to final 10%
(v/v)), + rinse with 70% Alcohol
Other chlorine products (Clidox®)
Iodine/iodophors (eg. Wescodyne®)
Alcohols (e.g. final 70% (v/v) EtOH or
IPA)
Phenolic agents (e.g. Biozide®,
Vesphene®)
Quaternary Ammonium Agents (e.g.
Roccal®, Coverage Plus®,
Cavicide®, Lysol®)
Aldehydes (e.g. 2-4% glutaraldehyde, 4%
formaldehyde, Cidex®)
Peroxygens (e.g. Virkon®)
Other, please specify:
6. Spills involving biological material will be handled in your laboratory using the following procedures (check all that apply):
(a) Describe which measures will be employed to handle spills in your laboratory:
Large spills or high-hazard spills will be reported to PI and BSO immediately for assistance
Spills in public (non-laboratory) areas will be reported to PI and BSO immediately
Spills involving high hazard agent(s) (e.g. Select Agents) will be reported to the PI and BSO immediately
Any injured individuals will be removed from areas and medical attention and follow-up will be provided
All personnel in area will be advised of hazard and told to avoid the area
Spill will be covered with copious absorbent material (like paper towels)
The spill will be decontaminated with an appropriate disinfectant for the agent(s) spilled for an appropriate contact period (see
below)
After decontamination, absorbent material will be disposed as biohazardous waste
After decontamination, the surface will be cleaned to remove residual disinfectant
Spills in equipment (e.g. Biosafety cabinets or centrifuges) will be disinfected according to written procedures on the MCG
Emergency Response Flip charts which have been posted in my laboratory
Application Date: _______________
101206
Principal
6 Investigator: ___________________________________________
Instruments
(b) Spills will be disinfected using the following disinfectant and contact time:
Disinfection/Decontamination Method
Contact time
(e.g. 30’)
Autoclaving
Chemical Methods:
Bleach (freshly diluted to final 10% (v/v))
Bleach (freshly diluted to final 10% (v/v)),
+ rinse with 70% Alcohol
Other chlorine products (Clidox®)
Iodine/iodophors (eg. Wescodyne®)
Alcohols (e.g. final 70% (v/v) EtOH or
IPA)
Phenolic agents (e.g. Biozide®,
Vesphene®)
Quaternary Ammonium Agents (e.g.
Roccal®, Coverage Plus®, Cavicide®,
Lysol®)
Aldehydes (e.g. 2-4% glutaraldehyde, 4%
formaldehyde, Cidex®)
Peroxygens (e.g. Virkon®)
7.
Protective equipment which will be utilized to minimize exposure of personnel to agents while in the laboratory:
(check all that apply):
Gloves (nitrile or latex)
Double Gloves (nitrile or latex)
Lab coat
Tyvek coveralls
Rear-closing gowns
Cuffed wrists on gowns
Sleeve protectors
Scrubs
Shoe covers/booties
Biosafety Cabinet
Safety glasses
Goggles
Face shield
Plexiglass shield
Safety caps/Sealed rotors on
Centrifuge
Surgical mask
N95 Respirator
PAPR Respirator
Aprons
Rubber boots
Other (please specify)
8. Protective equipment which will be utilized to minimize exposure of personnel to agents while working with animals (if applicable):
Agents will be delivered into animals using which BSL containment practices and standards:
BSL-1
BSL-2
BSL-3
Please indicate Personal Protective Equipment (PPE) and other safety equipment to be utilized while delivering agents into animals
(check all that apply):
Gloves (nitrile or latex)
Cuffed wrists on gowns
Safety glasses
Surgical mask
Double Gloves (nitrile or latex)
Sleeve protectors
Goggles
N95 Respirator
Lab coat
Tyvek coveralls
Scrubs
Shoe covers/booties
Rear-closing gowns
Biosafety Cabinet
Face shield
Plexiglass shield
PAPR Respirator
Aprons
Rubber boots
Other (please specify): ______________________________________________________________________________
After delivery of agents into animals:
After delivery of agents, animals will be housed in (check all that apply):
Separate cages from other animals
Microisolator cages
Well-labeled cages indicating possible hazards to animal staff
Cages with filter-top lids
Conventional/ABSL-1 facilities
ABSL-2 facilities
ABSL-3 facilities
Live animals will not be returned to LAS facilities after delivery
Other (please specify): _________________________________
How long after delivery of agents will animals be analyzed and/or sacrificed (indicate time range)? _________________________________
Application Date: _______________
101206
Principal
7 Investigator: ___________________________________________