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IMPLEMENTATION OF A BSL2
CERTIFICATION PROGRAM AT
NORTHWESTERN UNIVERSITY
Iwona Spath, RBP
Biological Safety Specialist
Office for Research Safety
2
“To certify BSL2 safety management
of our laboratories in adherence to
all regulations, guidelines, standards
and best practices”.
3
“To provide an opportunity for well
managed BSL-2 laboratories to
demonstrate and be recognized for
their contributions in promoting a
culture of safety within the institution”.
4
PROGRAM COMPONENTS
qInitial Annual Lab Inspection
qUnannounced Lab Inspection
qReview & Evaluation Process
qMaintenance of Accreditation & Requalification
5
THE PROCESS
6
INITIAL ANNUAL INSPECTION
General	Safety
Operational	Safety
Chemical	Storage	and	Waste
Biohazardous	Waste
Biosafety
Recombinant	and	Synthetic	Nucleic	Acids
Select	Agents	&	Controlled	Substances
Human	Cadavers	and	Body	Parts
BSL3	Inspections
Shop	Questions
Laser	Safety
Radioactive	Materials
BSL2	Certification	Unannounced	Inspection
Supplemental	Findings
7
GENERAL SAFETY
Examples:
q Profile , laboratory hazards, lab locations, and workers are up to date
q Training
q Specialized SOPs uploaded
q Emergency Information and procedures up to date
q First Aid Kit and Spill Kit present
q Appropriate PPE used and in good condition
8
OPERATIONAL SAFETY
Examples:
q Evidence of no eating
q 28 inches clear for aisles and exists and 18 inches clearance from the ceiling
q No protruding objects on bench tops and floors
q Eye wash and safety showers accessible
q Chemical fume hood certified
q Vacuum pumps vented
9
CHEMICAL STORAGE AND WASTE
Examples:
q Proper labels and closure of waste
q Puncture resistant containers
q Proper labeling of peroxides
q Proper segregation based on hazard
q Functional chemical storage cabinets
q Restraints for gas cylinders and more…
10
BIOHAZARDOUS WASTE & BIOSAFETY
Examples:
q Proper bags and containers used
q Sharps disposal, including tips and serological pipettes
q Certification of BSC
q Disinfectants
q Cold storage and inventory
11
RECOMBINANT & SYNTHETIC NUCLEIC ACIDS
Examples:
qIs the work registered?
qIs the work annually updated?
q Are any changes registered?
12
Select Agents and Controlled Substances
Examples:
q Registration
q Electronic Toxin Inventory
q RO notified
q Controlled substances storage and ownership
13
UNANNOUNCED LAB INSPECTIONS
q Focus on biological safety
q Twenty-three questions pulled from different review sections
q Two unannounced lab inspections within three months
14
15
REVIEW AND EVALUATION PROCESS
q Deficiencies corrected within 2 weeks
q Report submitted to Office for Research Safety (ORS)
q Approval
16
Maintenance of Certification & Requalification
q Granted for 2 years
q Lab’s responsibility to maintain safety culture and compliance
q Unannounced BSL-2 laboratories inspection and unofficial visit
q Active communication with ORS (any changes must be reported)
q Right to withdraw for failure to comply
17
18
q Program initiated July 1, 2017
q BSL2 labs - 230 PIs in Chicago and 55 in Evanston
q First Phase: few labs selected on each campus: Evanston and Chicago
(excellent laboratory safety track record)
Ø Status – in progress
Ø Evanston: six labs obtained BSL2 certificates (two in process)
Ø Chicago: eight labs obtained (two in process)
q Second Phase: invitation will be extended to additional qualified labs (good
laboratory safety track record)
Ø Status – in planning
19
Number	Enrolled
Number	Completed
2017	Goal
0
5
10
15
20
25
Chicago	Campus Evanston	Campus
BSL-2 Certification Progress and Goals
Number	Enrolled Number	Completed 2017	Goal
20
CHALLANGES
Labs:
ü Commitment
ü Extra Work
ü Frequent Visits from ORS
Lab Safety Specialists:
ü Convincing
ü Persuading
SOLUTION
“The right start”
21
A FEW STEPS BACK…
How did we get here and how do we assist the
labs?
22
EVOLUTION	OF	THE	SAFETY	PROGRAM	
& THE	OFFICE	FOR	RESEARCH	SAFETY
Growth	by	numbers	and	professional	diversity
Professional	expansion	of	the	staff:	microbiologists,	chemists,	
engineer,	biochemist,	veterinarian,	health	physicists,	training	
staff,	administrative	and	support	assistants,	and	multimedia	
designer.
23
MEET	THE	TEAM
24
ORS WORK AND SUPPORT FOR THE LABS
Safety Supply Catalog (free of charge):
§ Hazard Communication Signs & Labels
§ Hazardous Waste Tags and Chemical Waste Bags
§ 1-Quart and 1-Gallon Wide-Mouth Jars
§ Safety Glasses
§ Safety Waste Funnel for 1-Gallon Jugs
§ Peroxide Test Strips
§ Incineration Box and Bio Waste Bags
§ Cut Resistant Gloves
§ Blue FR Rated Lab Coats and White Lab Coats
25
26
ORS SERVICES - WEB BASED TRAINING
§ Biological Safety Certification
§ Bloodborne Pathogens for Clinical or Research Lab Workers Certification
§ Compressed Gas Cylinders Certification
§ Hazardous Chemical Waste Management Certification
§ Laboratory Safety Certification
§ Personal Protective Equipment Certification and more …
27
ORS SERVICES - INSTRUCTOR LED TRAINING
Safe	Shipping	of	Biological	Materials	and	Dry	Ice	Certification
28
§ Biological	Research	Groups	Meetings
§ Safety	Designate	Meetings:	Chemistry	and	Engineering	
Departments	
§ Northwestern	Laboratory	Safety	Focus	Group
§ Lunch	and	Learns
SAFETY	SESSIONS
29
ADDITIONAL SERVICES
30
INSTRUCTIONAL	FLYERS	&	LABELS
31
q We expect that this program will help laboratories:
Ø To understand the importance of a culture of safety
Ø To foster and/or improve a working relationship with
biology-focused labs.
q Following successful implementation:
Ø We hope to develop similar programs for chemistry-,
physics-, and engineering-focused laboratories.
32
The success of the program (to enlist as many qualified
BSL2 labs as possible):
§ Will make a difference in the daily operating routines
of the labs
§ Will provide safer environment for everyone
§ Will improve the safety management system for ORS
including safety inspections of biological laboratories
OUTCOMES
33
"I wish to express that the XXX lab is delighted to receive the BSL2 accreditation. In
my opinion, the process of obtaining BSL2 accreditation is fairly straightforward and
simple. As we recently set up our BSL 2 facility in the lab, we had some minor issues
but we fixed them effectively with the help from ORS, specifically from XXX. I would
encourage every lab to participate in this certification process. If nothing else, this
process will help to improve the safety standards of the lab, which will contribute
to improving the quality of research."
“XXX lab took part in BSL2 certification program-2017. We had few inspections
performed by the Biosafety Specialist. They went just fine. Nothing extra, just regular
maintenance of the lab”.
34
ACKNOWLEDGMENT
Hongliang	Yang,	Ph.D	- for	assistance	in	the	program	development
ORS	Staff:	Robert	Foreman,	Andrea	Hall,	Michael	Blayney,		Marina	Zelivyanskaya,	
Lucy	Galindo,	Cindi	Mason,	Gwen	Sulivan,	and	the	participating	labs.

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IMPLEMENTATION OF A BSL2 CERTIFICATION PROGRAM AT NORTHWESTERN UNIVERSITY