Biosafety in the Workplace
PLS 4/595D /Regulations and
Laboratory Management
Spring Semester, 2006
Mark J. Grushka, M.S., CSP
Manager, Biosafety and Biosecurity
University of Arizona
Main Topics
Part 1 Introduction to Biological Safety
Principles (Tuesday/April 11th)
 Part 2 Introduction to Regulatory
Framework (Tuesday/April 11th)
 Part 3 Biosafety Program Management,
Application of Project Management
Techniques and Case Studies

Part 1 Introduction to Biological
Safety Principles
Definitions
 Key Principles
 Data on Laboratory Acquired Infections
 Risk Assessment
 Biosafety Containment Levels
 Primary Containment
 Emergency Preparedness

Introduction to Biosafety
Principles


Complex relationship between organisms and
hosts. We are surrounded by countless
microorganisms. Our bodies depend upon them
for natural processes such as digestion. But most
of time, we do not get sick because of natural
defenses.
Infectious (pathogenic) organisms must:
– Attach and survive hosts defenses
– Multiply
– Create signs and symptoms of disease in host
Definitions
Safety
 Risk
 Biosafety
 Biosecurity

Safety
Freedom from harm
 Control of accidental losses involving

– People
– Property
– Loss to process
Risk

The chance that something may or may not
happen. Often defined as:
– Frequency (how often)
– Severity (how bad)
Biosafety

“Development and implementation of
administrative policies, work practices,
facility design, and safety equipment to
prevent transmission of biological agents
to workers, other persons or the
environment”
MMWR December 6, 2002
Biosecurity

“Protection of high-consequence microbial
agents and toxins, or critical relevant
information, against theft, or diversion by
those who intend to pursue intentional
misuse”
MMWR December 6, 2002
Koch’s Postulates

1890 Robert Koch Established List of Criteria to
Judge Whether or Not a Given Microbe Was
Responsible for a Given Disease
– The organism must be present in every case of the
disease
– The organism must be isolated from the diseased host
and grown in pure culture
– The specific disease must be reproduced when the
pure culture is inoculated into a healthy susceptible
host
– The organism must be recovered from the
experimentally infected host
Biohazardous Materials


Include All Infectious Organisms (Bacteria,
Chlamydiae, Fungi, Parasites, Prions,
Rickettsias, Viruses) which can cause disease in
humans or cause significant environmental or
agricultural impact.
Materials that may harbor infectious organisms
such as human or primate tissues, fluids, cells,
cell cultures.
Key Principles of Biosafety

Laboratory Practices and Techniques
– Hand Washing Important
– Manipulation of Material to Minimize Aerosols
– Consistent Use of Personal Protective Equipment

Safety Equipment (Primary Barriers)
– Biological Safety Cabinets (BSC’s)

Facility Design and Construction (Secondary
Barriers/Room Design)
– Room Pressure Negative to Corridor
– Controlled Access to Non-Research Personnel

Medical Surveillance
Typical Routes of Entry for Viral
or Bacterial Pathogens
Inhalation
 Ingestion
 Injection

– Needle sticks
– Accidental cuts with sharp objects

Skin or Eye Exposure
Laboratory Acquired Infections
Risk of Laboratory Associated Infections
(LAI’s) is Real
 Historical Examples Include:Brucellosis,
Q Fever, Hepatitis, Typhoid Fever,
Tuberculosis, Hepatitis
 Of the 3921 LAI Only 703 (18%) Caused
by Identifiable Accidents including needle
sticks, broken glass, spills or sprays (R.M.
Pike 1976)

40 Years of Data on Overt LAI’s
Pike, R.M. 1978 Various Classes of Agents
No. of Case
No. of Deaths
No. of Agents
Involved
No. of
Published
Cases
Bacteria
1704
71
37
744
Viruses
1179
55
85
915
Rickettsiae
598
25
8
381
Fungi
354
5
9
313
Chlamydiae
128
10
3
71
Parasites
116
2
17
74
Totals
4079
168
159
2498
Agent
Ten Most Frequently Reported
LAI’s
Pike, R.M. 1978 Past and Present Hazards of Agents
Infection
No. of Cases
No. of Deaths
Brucellosis
426
5
Q Fever
280
1
Hepatitis
268
3
Typhoid Fever
258
20
Tularemia
225
2
Tuberculosis
194
4
Dermatomycosis
162
0
Venezuelan Equine
Encephalitis
146
1
Psittacosis
116
10
Coccidiodomycosis
93
2
Totals
2168
48
University’s Responsibilities



To provide a workplace free of recognized
hazards. UA Policy and OSHA Requirement
To provide training to employees in order to
recognize hazards and to protect employees
against those hazards.
Methods of controlling risk may include:
– Building Design Including Containment Features
(Primary/Secondary)
– Policies/Procedures (SOP’s)
– Personnel Protective Equipment
– Medical Surveillance Programs
Basic Risk Assessment
Framework
Hazard Identification
 Estimate Probability of Occurrence
 Decide on Acceptable and Non-Acceptable
Practices
 Implement Practices
 Monitor

Example of Risk Assessment
for Cell Culture
BELGIAN BIOSAFETY SERVER
http://www.biosafety.be/CU/animalcellcultu
res/mainpage.html – Introduction
 Bioline International
http://www.bioline.org.br/request?by95008

Risk Assessment Flow Chart
Employee Responsibilities




If you don’t know, ask.
If you have not been trained to do it, don’t!
Follow established biosafety practices and
procedures. Always ask Principal Investigator.
Immediately inform Principle Investigator or
Laboratory Manager if any accidents, spills,
procedural issues/concerns or any questions arise
about your safety or the safety of others.
Biosafety Levels Defined
BSL-1
 BSL-2
 BSL-3
 BSL-4

Biosafety Level One (BSL-1)

BSL-1 Work with Well Characterized Agents Not
Known to Cause Disease in Healthy Adults.
Standard Microbiological
– Open bench tops acceptable with good standard
microbiological practices
– Laboratory not necessarily separated
– Special containment equipment or facility design not
required

Examples include E. coli K-12, Bacillus subtilis
Also Called “Bench Work”.
Biosafety Level Two (BSL-2)

BSL-2 Work with Moderate Potential to Affect
Personnel and Environment. (Herpes, Influenza
viruses, Legionella sp.)
– Personnel are specifically trained to handle pathogenic
agents
– Lab access limited when work is conducted
– Extreme precautions taken when handling
contaminated sharp items (needles, scalpels)
– Appropriate immunizations are administered when
available and baseline serum samples encouraged
– Certain procedures require biological safety cabinets
Biosafety Level Three (BSL-3)

BSL-3 Work May Cause Serious or
Potentially Lethal Disease as a Result of
Exposure to Inhalation Route. (M.
Tuberculosis, Bacillus anthraces)
–
–
–
–
Very specific training
Biosafety Cabinets used
Appropriate PPE and other clothing
Specific engineering and design features
Additional (BSL-3)
Requirements
Immunization and medical surveillance
protocols required
 No open bench work
 Ducted exhaust air ventilation creates
directional airflow from “clean” toward
“contaminated” areas prior to discharge to
outside
 High Efficiency Particulate Air (HEPA)
filters may be required for room exhaust

Biosafety Level Four (BSL-4)

BSL-4
Work with dangerous and exotic
agents which pose a high risk of aerosoltransmitted laboratory infectious and life
threatening disease. Ebola, Marburg,
– Special facility design features required
– All activities confined to Class III biosafety cabinets
(glove boxes), or Class II BSC’s used by workers
using one piece positive pressure personnel suits
ventilated by a life support system
Identifying Biohazard Risks



What am I Working
With? How Can it Cause
Disease and How do I
Protect Myself?
Routes of Entry Include
Inhalation, Ingestion,
Inoculation, Skin and
Eyes
Typical Risks of
Exposure Include
Contaminated Needles,
Mouth-Pipetting,
Splashing, Animal Bites
How to Protect Yourself
Knowledge and Understanding of the
Biohazards You Are Working With
 How Can it Get Onto/Into My Body
 How to Protect Myself (Hierarchy of
Control)

– Containment Equipment
– Techniques
– Personal Protective Equipment
Identifying Biohazard Risk is
Key



Accident/Incident
Preceded Events
Represented Only 18%
of LAI’s
Aerosols, Droplets and
Fomites are Likely
Sources
Lab Techniques With
High Potential for
Exposure Include:
– Centrifuges/Blenders,
Opening Tubes/Bottles,
Syringes/Needles,
Inoculating Loops,
Heating Over Flames
Mammalian Tissue Culture
Work

Risks
– Tissue culture may contain virus or bacteria capable
of spreading to human host
– Integrity of culture may be altered because of
contamination from outside source

How to Reduce Risks to Human and Cell
Culture?
– Manipulation of tissue cultures only under Class II
Biological Safety Cabinets
– Use care when doing any procedure using instruments
that may break skin
– Use proper PPE like latex gloves, eye protection
Class II Biological Safety
Cabinets Explained

Main Function
– Protects Worker
– Protects Work (Tissue Cultures From Microbial
Contaminants, i.e.. Integrity of Cultures)

Features
– High Efficiency Particulate Air (HEPA) Filter
Minimizes Escape of Contaminants Within Cabinet
Into Lab
– HEPA Filtered Air Supply Bathes Work Surface,
Protecting Work

Certified Annually by Facilities Management
Basis of Primary Containment
Isolate the Laboratory Worker from Biological Agent With
Ultra Filtered Directional Air Currents
Class II Type B1 Biological
Safety Cabinet Air Flow/HEPA
Filter Placement
Proper Use of Biosafety
Cabinets

Do’s
– Become familiar about the equipment by reading
users manual and asking PI.
– Keep laboratory doors closed and minimize
movement in front of cabinet to avoid disrupting
airflow. Avoid rapid arm movement in and out of
BSC.
– Decontaminate work surfaces with disinfectant before
and after working in a cabinet according to laboratory
standard operating procedures (SOP’s).
Proper Use of Biosafety
Cabinets

Don’ts
– Do not use cabinets as a permanent storage area for
supplies (disrupts airflow)
– Do not work inside cabinet with UV lamp on, if so
equipped. (skin/eye burns)
– Do not rapidly insert or withdraw arms. (disrupts
airflow)
– Place required equipment or supplies for procedure
inside before beginning work. (minimizes hand/arm
withdrawals which can disrupt airflow)
Eagleston Institute Biosafety
Cabinet Clips
What Does Your Lab Look
Like? Advantages of Good
Housekeeping




Reduces Risk of Slip,
Trip and Falls
Protects Integrity of
Biological Experiments
by Providing Adequate
Space and Reduce
Contamination Potential
Easier to Decontaminate
Surfaces
Saves Time by Being
Able to Find Stuff
Emergency Preparedness

What Should I Do When Things Go Wrong?
– Learn the types of emergencies that could happen



Spills of liquids
Equipment malfunctions
Exposure to potential pathogens through inhalation,
ingestion, skin including eye exposure, needle or other sharps
– Learn how to respond to minimize exposure time and
concentration
– Contact your supervisor to protect your health and
legal rights
Biohazard Spills



Each Lab Required to Have Spill
Decontamination Plan
PI Required to Have Cleanup/Decon Procedure
for Specific Biohazards Found in Lab
If Spill Occurs/General Guidelines
–
–
–
–
Remove affected clothing/gloves
Wash contaminated body areas with soap/H2O
Secure area until cleanup completed
Call UA Risk Management 621-1790 for technical
assistance
Summary


Risks of Working with Biological Materials in
Research are Real
The Risks Can be Managed Through:
– Properly Identifying and Assessing Biological Risks
– Good Laboratory Practice and Technique
– Correct Use of Safety Equipment (Primary Barriers) Including
Biological Safety Cabinets
– Facility Design, Construction and Maintenance (Secondary
Barriers)

Additional Resources are Available Through
Institutional Biosafety Committee and
Professional Staff
Regulatory Framework
PLS 4/595D /Regulations and
Laboratory Management
Spring Semester, 2006
Mark J. Grushka, M.S., CSP
Manager, Biosafety and Biosecurity
University of Arizona
Part 2 Introduction to
Introduction to Regulatory
Framework
What are the major regulations covering
biosafety?
 How is the University of Arizona
organized for biosafety compliance?
 What are the future implications for
regulatory control of biosafety?

Introduction

The regulatory framework covering
biosafety can be characterized as a
combination of statutes, regulations, rules
and guidelines from various federal and
state agencies, private and public
organizations and other interested parties
such as manufacturers of containment
equipment
Federal Laws
Occupational Health and Safety Act (OSHAct)

Bloodborne Pathogens (29 CFR 1910.1030)

Occupational Exposure to Hazardous Chemicals in
Laboratories (29 CFR 1910.1450)

Personal Protective Equipment
(29 CFR 1910.132-139)

Needlestick Standard
National Institutes of Health
NIH Office of Biotechnology Activities
 NIH Guidelines for Research Involving
Recombinant DNA Molecules
 IBC Resources

USDA

APHIS
USDOT
HazMat Safety
 Hazardous Materials Regulations (49
CFR 100-185)

US EPA
Hazardous Waste
 Microbiology
 IAQ

Select Agents
All individuals who have access to Select
Agents must undergo a Security Risk
Assessment
 Acquisition, use, transfer and disposal of
Select Agents is monitored by
CDC/APHIS through issuance of
registration

How is the UA Organized to
Comply?
Compliance based at Vice President for
Research Office
 Manager of Biosafety and Biosecurity
 Chairman of the Institutional Biosafety
Committee
 Program Coordinator

UA and Regulatory Reality
Check

Institution Governed by Many Internal
Policies and External Laws/ Regulations
– Provides a “Road Map” for Establishing and
Monitoring Effectiveness of Biosafety
Program
– Keys to Success
Accountability (Who is in Charge)
 Clear Goals and Objectives
 Periodic Monitoring

Regulations and Guidelines for
Biosafety at UA

Occupational Safety and Health Act (OSHA)
– Blood borne Pathogen Standard (Required Training
for All Employees Who Work With Human
Tissues, Blood or Other Bodily Fluids Must Take
Course From UA Risk Management)




University of Arizona Biosafety Handbook
Biosafety in Microbiological and Biomedical
Laboratories (CDC/NIH)
NIH Guidelines for Research Involving
Recombinant DNA Molecules
Laboratory Specific Procedures (SOP’s)
Institutional Biosafety
Committee Requires a Written
Plan from PI for These Types of
Research
Recombinant DNA
 Pathogenic Microorganisms
 Mammalian Cell Lines
 Gene Therapy

Institutional Biosafety
Committee Basics
Reports to Vice President for Research
 Insures a safe working environment by
minimizing exposure of personnel to
harmful biological agents
 Peer Review of research conducted at or
sponsored by the U of A for compliance
with adopted policies, regulations and
guidelines

Where to Get More Information
(IBC Website) http://www.ibc.arizona.edu
 (Risk Management Website) http://www.
w3fp.arizona.edu/riskmgmt
 http://cdc.gov
 http://labor/osha.gov

Mark J. Grushka, Manager, Biosafety and
Biosecurity 621-5279 and Margaret Stalker,
Program Coordinator 621-3441
Criteria for Review
Use of Pathogenic Materials
 Use of rDNA techniques
 Use of Cell Culture
 Transgenic Plants
 Gene Therapy

Memorandum of Understanding
and Agreement Form
Is the main risk assessment document
submitted by Principal Investigators
 Submitted in on-line form
 Reviewed at least twice

– Prereview
– Committee Review

Approval from IBC allows PI to conduct
research at specific BSL level
Auditing Function
All BSL-3 laboratories audited annually by
Manager of Biosafety
 All Select Agent laboratories audited
annually by Manager of Biosafety
 All BSL-1 applications require an on-site
inspection prior to consideration by IBC

Other Resources

Training
– Bloodborne Pathogen and Shipping of
Hazardous Materials by Air done by Risk
Management and Safety
On-line UA Biosafety Handbook
 Program Manager,Manager of Biosafety
and IBC Chair available to respond to
technical or regulatory questions

Guidance Documents



World Health Organization Biosafety
Manual http://www.who.int/csr/delibepidemics/
WHO_CDS_CSR_LYO_2004_11/en/
2nd Edition Primary Containment for
Biohazards:Selection, Installation and
Use of Biological Safety Cabinets
http://www.cdc.gov/od/ohs/biosfty/bsc/bsc.htm
Biosafety in Microbiological and
Biomedical Laboratories (BMBL) 4th
Edition
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4t
oc.htm
Part 3 Biosafety Program
Management, Application of
Project Management
Techniques and Case Studies
PLS 4/595D /Regulations and
Laboratory Management
Spring Semester, 2006
Mark J. Grushka, M.S., CSP
Manager, Biosafety and Biosecurity
University of Arizona
How to Organize a Biosafety
Management Program
Goals
 Elements
 Risk Assessment
 Training
 Medical Surveillance
 Documentation

Goals
 To
prevent employees and their families from
acquiring laboratory-associated infectious
diseases
 To
prevent contamination of the environment and
promote environmental quality
 To
comply with all National, International and
Local regulations for the use of biohazards
 To
conform to prudent Biosafety practices
Slide2
ELEMENTS OF A BIOSAFETY
PROGRAM

Organization

Biosafety Manual

Registration and Inventory Control

Risk Assessment and Control of Biohazards

Biosafety Training

Emergency Response

Medical Surveillance

Auditing Program

Documentation
Slide7
ELEMENTS OF A BIOSAFETY PROGRAM
Organization
Management Commitment Through Leadership
Designation of a Biosafety Officer
Management appoints an individual qualified by training and
experience
Role of Site Safety Teams
Establish a mechanism to monitor and control the use of
biohazards which can be done through the Site Safety Team
Establishment of Responsibilities:
Designate responsible individuals:
Management
Biosafety Officer (Site Safety Leader)
Committees
Supervisors
Associates
Slide 8a
ELEMENTS OF A BIOSAFETY PROGRAM
Organization
Site Biosafety Committee(s)

Biosafety Committee (CDC)
–
–
–
–

Infectious Agents (Viruses, Bacteria, Parasites)
Infected Materials (Human Blood, Body Fluids, Tissues)
Animal Pathogens (live vaccine challenges)
Zoonotic Agents (non-human primates, other animals)
Institutional Biosafety Committee (NIH)
–
–
–
–
–
recombinant DNA (rDNA) Work with Restricted Agents
Infectious Host Vectors
Human Gene Transfer Experiments
Transgenic Animals
Cloning of Toxin Molecules
Slide8b
ELEMENTS OF A BIOSAFETY PROGRAM
Biosafety Manual

Develop a Biosafety Manual to include:
– Engineering Controls



Biosafety Cabinets (BSCs) [BSL-2/3]
HEPA filtered glove boxes (BL-3)
Sealed centrifuge cups
– Work Practice Controls

Decontamination of lab surfaces daily
– Standard Operating Procedures for Work in the
Microbiology Lab:



Handling of Cultures/Samples
Spill Response/Decontamination
Biohazard Waste Decontamination/Disposal
– Training Program and Documentation
– Vaccination Program (as required)

Hepatitis B Vaccine/ Vaccinia virus vaccine
Slide9
ELEMENTS OF A BIOSAFETY PROGRAM
Registration and Inventory Control
Registration
Identify Infectious Agents (e.g., Mycobacteruium tuberculosis, Brucella melitensis)
Determine the Biosafety Level (BSL 1, BSL-2, BSL-3)
Identify Procedures (description of work, aerosol generating, culture
work, waste treatment, spill clean-up, etc.)
Identify appropriate storage conditions (refrigeration, frozen at -20 or 70 degrees C, freeze-dried)
Assign Responsibilities to designated individuals
Inventory Control
Document Physical Inventory
Document Location of Infectious Agents
Document Controls to be Used such as Biosafety Cabinets, special
equipment (sealed centrifuge rotors, etc.)
Document Assigned Responsible Individuals
Slide10
BIOHAZARD RISK ASSESSMENT
Identify Hazard
Biohazard identity/name
e.g., Mycobacteruium tuberculosis, Brucella melitensis
Infectious to humans
Humans are the primary host
Infectious to animals
Animals are the primary host or reservoir of agent
Infectious for other living things in the environment
Plants, algae, insects
Slide11a
BIOHAZARD RISK ASSESSMENT
Quantify Risk

What is the Biosafety Level (BL-1,BL-2,BL-3)

What is the amount of infectious material present

What is the infectious dose (amount of infectious material
needed to cause infection in a normal person)

What is the mode of infection
– aerosol, percutaneous, ingestion, absorption

What is the Portal of Entry
– Nose via inhalation
– Through the skin via injection or puncture
– Mouth via eating or drinking
– Directly on the skin or an abrasion of the skin
Slide 11b
BIOHAZARD RISK ASSESSMENT
Quantify Risk (Continued)
What is the Condition of the Host
Immunocompromised because of drug therapy or illness
Immunocompromised due to a primary infection and therefore more
susceptible to secondary opportunistic infections
What is the Availability of Vaccine
Is there a vaccine available against the biohazardous agent
What is the protective factor of the vaccine (is it effective for 60%,
80% or 100% of all individuals)
What is the Availability of Drug Treatment
Is the biohazardous agent susceptible to antibiotic treatment
What is the resistance of the agent for antibiotic treatment (e..g.,
multi-drug resistant M. tuberculosis)
Is there a drug therapy for viral agents (e.g., acyclovir, pencyclovir)
Slide11c
BIOHAZARD RISK ASSESSMENT
Identify Controls
Hierarchy of Controls

Substitution/Elimination
– Use a non-pathogen whenever possible

Engineering Controls
– Primary Containment
•
•
Biosafety Cabinets,
Glove Box Enclosures
– Secondary Containment
•
Building Design Features
 negative air pressure
 floor to ceiling walls
 closed doors
Slide 12a
BIOHAZARD RISK ASSESSMENT
Identify Controls
Hierarchy of Controls (continued)

Administrative Controls
–
–
–
–
–

Frequent hand washing
Frequent changing of PPE
Removal of PPE when leaving work area
Prohibition of eating, drinking, smoking, chewing gum
Limiting use of needles and sharps
Personal Protective Equipment
– Protective eyewear
•
Safety glasses with side-shields or facemask
– Protective outer wear
•
Use of latex gloves, lab coats
– Respiratory Protection
•
HEPA filter mask (Dust-mist, N95, N100, etc.)
Slide 12b
ELEMENTS OF A BIOSAFETY PROGRAM
Biosafety Training

Identify Agents to be Used
– To ensure that workers know signs/symptoms of infection and
pathogenicity of agent used

Provide General Biosafety Training
– To ensure that workers know the basics of Biosafety Practices:

•
Microbiological aseptic techniques
•
Proper techniques for decontamination/disinfection
•
Selection and use of Personal Protective Equipment
Provide Task-Specific Training
– Especially critical for work in BLS-2 and BLS-3 areas

Provide Information on Appropriate Vaccination(s)
– Workers need to know all about the vaccine(s) they will be using (e.g.,
efficacy, side effects, booster requirements, etc.)

Evaluate Effectiveness of Training
– Quizzes, Tests, Observations, Performance Evaluations
Slide 15
ELEMENTS OF A BIOSAFETY PROGRAM
Emergency Response
Develop Written ER Procedures
Ensure the ERP is accessible to all employees (located in critical areas)
Ensure the ERP is communicated to employees and outside agencies
Ensure Adequate Training
Employees must be trained to the appropriate response level
Ensure Use of Appropriate PPE
Employees need to be involved in the selection process
Employees need to be trained in the use and maintenance of PPE
Supervisors need to encourage/enforce use of PPE
Practice ER Drills
The ERP needs to be practices (emergency evacuation, spill clean-up)
Ensure Post-Exposure Medical Surveillance
Injured responders must report injury and get medical attention/follow-up
Slide 16
ELEMENTS OF A BIOSAFETY PROGRAM
Medical Surveillance

Baseline Physicals
– Employee’s history, Family history, Serum banking

Immunizations (as appropriate)
– Vaccination, Titre checks

Emergency First-Aid
– Medication, Consultation, Medical Follow-up

Adequate Training in Recognition of Symptoms
– Provided to employees at risk

Accident/Injury Reporting Procedure
– Investigation, Root Cause Analysis
Slide17
ELEMENTS OF A BIOSAFETY PROGRAM
Auditing Program
Types of Audits/Inspections
Regular Self-Inspections conducted by designated employee(s) on a
routine basis (daily/weekly)
Supervisor Self-Inspection conducted by the supervisor on a
weekly/monthly basis to reinforce regular employee inspections
Site/Department Inspection
Performed quarterly by a site team of employees, supervisors and site
management representative(s)
Periodic External Audit
Performed annually by auditor outside of the site operations (e.g.,
Corporate staff, another site, an outside consultant)
Inspection Follow-up
Ensure corrective actions are taken to eliminate identified deficiencies
Slide 18
ELEMENTS OF A BIOSAFETY PROGRAM
Maintain Documentation
Registration Approval
Signed by the Investigator, the Department Director and the Biosafety Officer
(Safety Coordinator)
Medical Records
For medical clearance, physicals, vaccinations, diagnostic test results, postexposure evaluations, annual check-ups
Vaccination Records
Include declinations where appropriate
Date of vaccination, blood titers, booster requirements and completion of
vaccination protocols
Training Records
Document initial training, supervisor training, refresher training
Include dates, trainer qualifications, course syllabus, sign-in sheet, method of
evaluation (tests/quizzes), certificates issued
Auditing Records
Ensure all inspections/audits are documented including actions taken
Slide 19
Documentation Framework
Policy
Mandatory
Global Goal Orientated
Other equivalent Global Preferred
means allowed
Approach
Not mandatory
unless
mandated
by Standard
Standards
Auditable
Codes
(Management Systems)
Audience
Specific
MSDS
Tech Info Training Sector
Guidance
Specialist
Reference
Should vs. Shall
Tools
Product
Info
The Vice President for
Research’s Walkabout for
Biosafety

Introduction
In the spring of 2001, Vice President for
Research and Graduate Studies, Dr. Richard
Powell initiated a program to acknowledge
excellence in research through successful
integration of the principles and practices of
biosafety management. The success of research
depends on intelligent identification, evaluation,
and control of risk. The following exemplifies
how this is being accomplished at the University
of Arizona.
Examples of the Walkabout
Dr. Friedman’s TB Lab Noted for Excellence in Biosafety
Procedures May 2001
http://www.ahsc.arizona.edu/opa/ahsnews/may01/powe.htm
Shubitz’s Valley Fever Lab Recognized for Biosafety Excellence
July 2001
http://uanews.opi.arizona.edu/cgibin/WebObjects/UANews.woa/1/wa/LQPStoryDetails?ArticleID=39
22&wosid=UtPtDpXbJrhSbEVlsgCHxg
VP Research Recognizes Three for Biosafety Excellence October
2001
http://uanews.opi.arizona.edu/cgibin/WebObjects/UANews.woa/wa/MainStoryDetails?ArticleID=438
4
VP Research Recognizes Biological Cabinet Maintenance Staff for
Biosafety Excellence
January 2002
http://uanews.opi.arizona.edu/cgibin/WebObjects/UANews.woa/wa/LQPStoryDetails?ArticleID=4
796
Examples of the Walkabout
Sterling Parasitology Laboratories Recognized as a Model of
Biosafety Excellence April 2002
http://ali.opi.arizona.edu/cgibin/WebObjects/UANews.woa/1/wa/LQPStoryDetails?ArticleID=53
24&wosid=dFxhwGQJUxgVVczUhMKgq0
VP Research Recognizes UA Unit for Managing Hazardous Waste
July 2002
http://uanews.opi.arizona.edu/cgibin/WebObjects/UANews.woa/1/wa/LQPStoryDetails?ArticleID=58
80&wosid=fUuz5a8K0ndElr2pg4xHgM
VP Research Recognizes Mirror Lab for Excellence in Health,
Safety Leadership December 2002
http://uanews.opi.arizona.edu/cgibin/WebObjects/UANews.woa/5/wa/LQPStoryDetails?ArticleID
=6521&wosid=CuIsRJGISTHGsQtpJ3cu30
http://
Examples of the Walkabout
VP Research Focuses Walkabout on Microbiology and Biosafety
April 2003
http://uanews.opi.arizona.edu/cgibin/WebObjects/UANews.woa/5/wa/LQPStoryDetails?ArticleID=72
25&wosid=gvjtwRNtmTIsrxIFWDDTig
VP Research Recognizes Biosafety Excellence in Molecular
Agriculture Research October 2003
http://uanews.org/cgibin/WebObjects/UANews.woa/wa/MainStoryDetails?ArticleID=810
3.
University Animal Care, Research Labs Designed with
Effectiveness, Safety in Mind January 2004
http://uanews.opi.arizona.edu/cgibin/WebObjects/UANews.woa/5/wa/LQPStoryDetails?ArticleID=86
04
Examples of the Walkabout
Veterinary Diagnostic Lab Integral to Risk
Assessment March 2004
http://ali.opi.arizona.edu/cgibin/WebObjects/UANews.woa/5/wa/LQPStoryD
etails?ArticleID=8856
VP Research Highlights Excellence in UA
Animal Hazards Program September 2004
http://ali.opi.arizona.edu/cgibin/WebObjects/UANews.woa/7/wa/LQPStoryD
etails?ArticleID=9759
Scenario 1:
The Dedicated Post-Doc
 Situation:
– A new Post-Doc has just arrived from a prestigious University. He is
working on improving the production of Interferon from a human
cell line. Unfortunately the cell line also produces Human T-cell
leukemia virus. He brings this cell line in from the University where
he was working before and decides to grow it up in incubators in
several labs without telling anyone else working in those labs that it is
also co-contaminated with HTLV III.
 What
 How
do you do?
can this have been avoided?
Slide 21
Scenario 2:
The Helpful Lab Worker
 Situation:
– A lab assistant in a private lab is working with a mouse cell line that
has been genetically modified to produce the entire genome of HIV
without the LTR sequences (so it is non-infectious). She has been
contacted by a very prestigious colleague from another private
institution in Europe and was invited to visit their lab. She decides to
take along a vial of her cell line packaged in liquid nitrogen. To make
sure there is no delay she is hand carrying the vial on the plane in her
carry-on bag.
 Is
this wrong?
 Why?
 How
can this have been avoided?
Slide 22
Scenario 3:
The Reluctant Director

Situation:
– Your institution is just implementing a new Biosafety Program. Up
until now no one has ever questioned the Laboratory Animal Sciences
(LAS) Department about their work. The Director of LAS is
reluctant to have his department participate in this newfangled
program that is only going to hamper his group and make life more
difficult for him and his people.

What can you do to ensure that LAS
participates in the program?
Slide 23
Scenario 4:
The Busy Scientist
 Situation:
– A Nobel winning scientist is working in your company. He is a very
important person and is much too busy to attend any Biosafety
training sessions or let his assistants attend. Besides, what could you
possibly show him?
 What
do you do?
 How
can you convince him of the need to
attend training?
 How
can this have been avoided?
Slide 24