|
|
 |
University of Delaware
Biosafety Audit Form
Guidance Document
Administrative
1. A hard copy of the biosafeyt manual should be
accessible. The manual is also available on the web.
2. The emergency posting on exterior of room must have
current emergency contact information including phone numbers.
3. Labs working at BSL2 or higher must have a biohazard
symbol on their lab sing or lab door.
4. The Biohazard Registration Form must be
completed for
all biological work taking place under the Principle Investigator (PI)
and
submitted to teh Biosafety Officer on an annual basis.
5. A biological material inventory must be maintained and
updated annually. A copy must be submitted to the Biosafety Officer and
maintained in the lab. The inventory should be verified annually for BSL2
materials and at the Biosafety Officer's determination for BSL3 materials
and select agents.
6. A Job Hazard Analysis (JHA) or Standard Operating
Procedure (SOP) must be in place for any work involving infectious or
hazardous materials.
7. The PI must be familiar with the requirements for
import/export of their materials. If permits are required or currently
possessed the Biosafety Officer should be informed in conjunction with the
Biohazard Registration Form. Copies of any permits the lab has should be
provided to the Biosafety Officer.
8. The PI must be familiar with the requirements for USDA
or CDC permits for their work. If the PI has one of these permits, or
wishes to receive one, the Biosafety Officer must be informed. Copies of
any permits the lab has should be provided to the Biosafety Officer.
9. The lab must be secured when unattended. Permit
conditions requiring security of materials must be followed.
10. The lab should have a pest control program especially if
pests may be vectors for materials used in the lab.
Agents Used/Stored
1. Human materials include human blood, body fluids,
tissues and human cell lines. These require inclusion in the bloodborne
pathogens program.
2. Is work with recombinant DNA performed in the lab?
This requires a recombinant DNA registration form and compliance with the
National Institutes of Health (NIH) Guidelines.
3. Certain agents are included in the Select Agent
program and must be registered with the Centers for Disease Control (CDC)
or United States Department of Agriculture (USDA). Some materials are
exempt due to quantity limitations. The university has a program to
maintain compliance with these regulations including for the use of exempt
quantity materials.
4. Possession of infectious agents (BSL2 or higher) that
are infectious to humans, animals, or plants.
5. Toxins of biological origin. These fall under the
Highly Toxic Materials program and/or biosafety and require special safety
procedures, SOP's, and proper waste disposal.
6. Work with whole plants that are normal or healthy or
their tissues.
This may include exotic materials. Please note on the form if exotic
materials are used.
7. Work with infectious agents in a whole plant.
8. Work with transgenic plants or applying transgenic or
recombinant
materials to plants.
9. Work with whole animals that are normal or healthy or
their tissues.
10. Work with infectious agents in an animal.
11. Work with transgenic animals or inserting transgenic
materials into
whole animals.
12. Do you run gels in your lab? If so, what type(s)?
13. Do you work with any oncogenes? If so these require
special safety
procedures and Standard Operating Procedures (SOP's).
14. Do you have hazardous drugs, such as antineoplastics and
carcinogens,
in your lab? These fall under the Highly Toxic Materials program and
require special safety procedures, SOP's, and proper waste disposal. Do
you have any DEA controlled substances? These require special security,
recordkeeping, and waste disposal measures.
15. List any other biological materials not included above but
that may
fall under the biosafety program.
Training
1. Individuals working at BSL1 must take biosafety
awareness
training before starting their work. Individuals working at BSL2 or
higher must take biosafety training. Individuals working at BSL3 must
take training specific for the BSL3 facility also.
2. Individuals in the lab are familiar with the biosafety
program,
understand good microbiological techniques and have been instructed, and
are comfortable with, their specific lab tasks and procedures.
3. Anyone shipping hazardous materials themselves must
have documented
training. Individuals shipping materials on dry ice must have a current
dry ice training certificate.
4. All individuals in the lab are aware of the
university's procedures for
shipping or transporting biological and other hazardous materials.
Lab Procedures
1. Traffic through the lab is minimized when work
with
infectious or hazardous materials is taking place.
2. A sink, with soap, must be available for hand washing
prior to leaving
the lab.
3. An eyewash and safety shower must be accessible. Both
units must be
tested by Plumbing Services every six months. Eyewashes should be tested
by the lab staff every week if possible.
4. Refrigerators and/or freezers used to store human
blood or materials
must be labeled with a biohazard sticker. Contaminated equipment must be
labeled if it is to be serviced.
5. Necessary procedures are in place to minimize aerosol
generation or the
work is performed in a biosafety cabinet.
6. Use of sharps with infectious or hazardous materials
is limited where
possible.
7. Safety devices have been considered and implemented
where possible.
This is required when working with human materials under the bloodborne
pathogens program.
8. Food and drink, as well as their containers, are not
permitted in the
lab.
9. It is recommended that centrifuges with safety rotors
or sealed buckets
are used with infectious or hazardous materials.
10. Vacuum traps should be placed in a secondary container.
11. List disinfectants used in the lab.
12. Appropriate procedures exist for routine disinfection and
spill
clean-up for the lab. All lab staff are familiar with these procedures.
Chemical and biological spill materials are available.
13. Are there procedures for decontaminating the labs/rooms,
such as with
formaldehyde or chlorine dioxide? (This is only necessary for some
labs).
14. List agent(s) used, if any, for room decontamination.
15. All lab staff must be familiar with the procedures to
follow in the
event of a biological exposure. Is a copy of the Laboratory Emergency
Procedure Cards posted?
Laminar Flow Equipment
1. A laminar flow bench (LFB) is only being used for
nonhazardous work.
2. A LFB must have a pink warning sticker, blue "contact
EHS" sticker, and
an annual certification sticker.
3. A LFB must be certified annually through DEHS. This
certification
should be current or the effectiveness of the bench can not be
assured.
4. Biosafety cabinets (BSC's) should be located away from
doors, drafts,
air supply vents, and traffic patterns.
5. BSC's must be certified annually through DEHS. If
they do not pass the
certification they must not be used for infectious work. There must be a
certification sticker on the cabinet and a blue "contact EHS" sticker.
6. Clutter in the BSC must be limited to minimize airflow
disturbances.
7. The front grille must remain clear to minimize airflow
disturbances.
8. The use of flame devices is strongly discouraged in
BSC's. DEHS
recommends the use of an electric incinerator device in place of an open
flame.
9. Does the BSC have airflow alarms? Are they operating
correctly?
10. Most labs should be under negative pressure relative to the
hallway.
11. Is there any other specialized HVAC equipment servicing the
lab? Has it been certified in any way?
Personal Protective Equipment (PPE)
1. Lab coats should be worn in the lab.
Contaminated coats must remain in the lab. What provisions have been made
for the laundering of lab coats?
2. Appropriate gloves for the work must be worn.
Contaminated PPE must
remain in the lab. Do not wear gloves in clean areas or to open doors,
etc.
3. Safety glasses or goggles must be worn by everyone
whenever the lab is
active.
4. Face shields are necessary when there is a splash
hazard. They must be
worn in addition to safety glasses or goggles rather than in place of
them.
5. Shorts/skirts should come below the knee. Closed-toe
shoes should be
worn. Long hair should be tied back.
6. List other PPE used in the lab. Specific PPE must be
outlined in the
Job Hazard Analysis or SOP.
Autoclaves
1. List the location of the autoclave used by the
lab.
2. Is the room neat and clean, with no excess waste
sitting around?
3. What method does the lab use to verify kill?
4. Is PPE and other equipment to safely use the autoclave
available (gloves, cart for unloading, etc.)?
5. Has everyone who runs the autoclave been trained?
Infectious Waste
1. Waste boxes are taped on the bottom and top (when
closed). Boxes are lined with 2 red bags. Boxes weigh less than 45
lb.
2. Boxes, red bags, and strong tape are all available to
the lab.
3. Sharps containers should be placed at the locations
where sharps are generated in the lab.
4. Sharps containers must not be filled beyond the "fill
line". They must then be sealed and placed down into a lined infectious waste
box.
5. Labs that generate gels must know the procedures for
disposal of the gels and the related waste.
6. Labs that generate liquid infectious waste must have
procedures in
place for disinfecting and disposing of the waste. Only disinfected
infectious waste which is not chemically or radioactively contaminated may
be discarded down the sanitary sewer (lab sinks). Liquid waste disposal
procedures must be included on the Biohazard Registration Form for
approval.
Questions
regarding the biosafety audit form may be addressed to Krista Murray at klmurray@udel.edu or call 831-1433.
|
