Biosafety in the Workplace

1
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

2
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
  

3
Part 1 Introduction to Biological Safety
Principles

• Definitions
• Key Principles
• Data on Laboratory Acquired Infections
• Risk Assessment
• Biosafety Containment Levels
• Primary Containment
• Emergency Preparedness

4
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

5
Definitions

• Safety
• Risk
• Biosafety
• Biosecurity

6
Safety

• Freedom from harm
• Control of accidental losses involving
• People
• Property
• Loss to process

7
Risk

• The chance that something may or may not happen.
  Often defined as
• Frequency (how often)
• Severity (how bad)

8
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

9
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

10
Kochs 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

11
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.

12
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 (BSCs)
• Facility Design and Construction (Secondary
  Barriers/Room Design)
• Room Pressure Negative to Corridor
• Controlled Access to Non-Research Personnel
• Medical Surveillance

13
Typical Routes of Entry for Viral or Bacterial
Pathogens

• Inhalation
• Ingestion
• Injection
• Needle sticks
• Accidental cuts with sharp objects
• Skin or Eye Exposure

14
Laboratory Acquired Infections

• Risk of Laboratory Associated Infections (LAIs)
  is Real
• Historical Examples IncludeBrucellosis, 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)

15
40 Years of Data on Overt LAIsPike, R.M. 1978
Various Classes of Agents
16
Ten Most Frequently Reported LAIs Pike, R.M.
1978 Past and Present Hazards of Agents

17
Universitys 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 (SOPs)
• Personnel Protective Equipment
• Medical Surveillance Programs

18
Basic Risk Assessment Framework

• Hazard Identification
• Estimate Probability of Occurrence
• Decide on Acceptable and Non-Acceptable Practices
• Implement Practices
• Monitor

19
Example of Risk Assessment for Cell Culture

• BELGIAN BIOSAFETY SERVER
•  http//www.biosafety.be/CU/animalcellcultures/mai
  npage.html Introduction
• Bioline International
• http//www.bioline.org.br/request?by95008

20
Risk Assessment Flow Chart
21
Employee Responsibilities

• If you dont know, ask.
• If you have not been trained to do it, dont!
• 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.

22
Biosafety Levels Defined

• BSL-1
• BSL-2
• BSL-3
• BSL-4

23
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.

24
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

25
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

26
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

27
Biosafety Level Four (BSL-4)

• BSL-4 Work with dangerous and exotic agents which
  pose a high risk of aerosol-transmitted
  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 BSCs used by
  workers using one piece positive pressure
  personnel suits ventilated by a life support
  system

28
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
  

29
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

30
Identifying Biohazard Risk is Key

• Accident/Incident Preceded Events Represented
  Only 18 of LAIs
• 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

31
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

32
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

33
Basis of Primary ContainmentIsolate the
Laboratory Worker from Biological Agent With
Ultra Filtered Directional Air Currents
34
Class II Type B1 Biological Safety Cabinet Air
Flow/HEPA Filter Placement
35
Proper Use of Biosafety Cabinets

• Dos
• 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
  (SOPs).

36
Proper Use of Biosafety Cabinets

• Donts
• 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)

37
Eagleston Institute Biosafety Cabinet Clips
38
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

39
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

40
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

41
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

42
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

43
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?

44
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

45
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 

46
National Institutes of Health

• NIH Office of Biotechnology Activities
• NIH Guidelines for Research Involving Recombinant
  DNA Molecules
• IBC Resources

47
USDA

• APHIS

48
USDOT

• HazMat Safety
• Hazardous Materials Regulations (49 CFR 100-185)

49
US EPA

• Hazardous Waste
• Microbiology
• IAQ

50
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

51
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

52
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

53
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 (SOPs)

54
Institutional Biosafety Committee Requires a
Written Plan from PI for These Types of Research

• Recombinant DNA
• Pathogenic Microorganisms
• Mammalian Cell Lines
• Gene Therapy

55
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

56
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
57
Criteria for Review

• Use of Pathogenic Materials
• Use of rDNA techniques
• Use of Cell Culture
• Transgenic Plants
• Gene Therapy

58
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

59
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

60
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

61
Guidance Documents

• World Health Organization Biosafety
  Manual http//www.who.int/csr/delibepidemics/WHO_C
  DS_CSR_LYO_2004_11/en/
• 2nd Edition Primary Containment for
  BiohazardsSelection, Installation and Use of
  Biological Safety Cabinets http//www.cdc.gov/od/o
  hs/biosfty/bsc/bsc.htm
• Biosafety in Microbiological and Biomedical
  Laboratories  (BMBL) 4th Edition
  http//www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.h
  tm

62
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

63
How to Organize a Biosafety Management Program

• Goals
• Elements
• Risk Assessment
• Training
• Medical Surveillance
• Documentation

64
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
65
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
66
ELEMENTS OF A BIOSAFETY PROGRAM Organization
Management Commitment Through Leadership Designati
on 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 Des
ignate responsible individuals Management Biosafe
ty Officer (Site Safety Leader) Committees Supervi
sors Associates
Slide 8a
67
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
68
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
69
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
70
BIOHAZARD RISK ASSESSMENTIdentify 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
71
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
72
BIOHAZARD RISK ASSESSMENT Quantify Risk
(Continued)
What is the Condition of the Host Immunocompromise
d because of drug therapy or illness Immunocomprom
ised 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
73
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
74
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
75
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
76
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
77
ELEMENTS OF A BIOSAFETY PROGRAM Medical
Surveillance

• Baseline Physicals
• Employees 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
78
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) Supe
rvisor 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
79
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, post-exposure 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
80
Documentation Framework
Policy
Auditable
Standards
Mandatory Global Goal Orientated
Other equivalent means allowed
Global
Preferred Approach
Codes (Management Systems)
Should vs. Shall
Tools
Not mandatory unless mandated by Standard
Audience Specific
Product Info
Sector Guidance
MSDS
Training
Tech Info Specialist Reference
81
The Vice President for Researchs 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.

82
Examples of the Walkabout

• Dr. Friedmans TB Lab Noted for Excellence in
  Biosafety Procedures May 2001
•   http//www.ahsc.arizona.edu/opa/ahsnews/may01/po
  we.htm
•  Shubitzs Valley Fever Lab Recognized for
  Biosafety Excellence July 2001
•  http//uanews.opi.arizona.edu/cgi-bin/WebObjects/
  UANews.woa/1/wa/LQPStoryDetails?ArticleID3922wos
  idUtPtDpXbJrhSbEVlsgCHxg
•  VP Research Recognizes Three for Biosafety
  Excellence October 2001
•  http//uanews.opi.arizona.edu/cgi-bin/WebObjects/
  UANews.woa/wa/MainStoryDetails?ArticleID4384
•  VP Research Recognizes Biological Cabinet
  Maintenance Staff for Biosafety Excellence
• January 2002
• http//uanews.opi.arizona.edu/cgi-bin/WebObjects/U
  ANews.woa/wa/LQPStoryDetails?ArticleID4796

83
Examples of the Walkabout

• Sterling Parasitology Laboratories Recognized as
  a Model of Biosafety Excellence April 2002
•  http//ali.opi.arizona.edu/cgi-bin/WebObjects/UAN
  ews.woa/1/wa/LQPStoryDetails?ArticleID5324wosid
  dFxhwGQJUxgVVczUhMKgq0
•  VP Research Recognizes UA Unit for Managing
  Hazardous Waste
• July 2002
•  http//uanews.opi.arizona.edu/cgi-bin/WebObjects/
  UANews.woa/1/wa/LQPStoryDetails?ArticleID5880wos
  idfUuz5a8K0ndElr2pg4xHgM
• VP Research Recognizes Mirror Lab for Excellence
  in Health, Safety Leadership December 2002
• http//uanews.opi.arizona.edu/cgi-bin/WebObjects/U
  ANews.woa/5/wa/LQPStoryDetails?ArticleID6521wosi
  dCuIsRJGISTHGsQtpJ3cu30
•   
• http//

84
Examples of the Walkabout

• VP Research Focuses Walkabout on Microbiology and
  Biosafety April 2003
•  
• http//uanews.opi.arizona.edu/cgi-bin/WebObjects/U
  ANews.woa/5/wa/LQPStoryDetails?ArticleID7225wosi
  dgvjtwRNtmTIsrxIFWDDTig
•  
• VP Research Recognizes Biosafety Excellence in
  Molecular Agriculture Research October 2003 
• http//uanews.org/cgi-bin/WebObjects/UANews.woa/wa
  /MainStoryDetails?ArticleID8103.
•  
• University Animal Care, Research Labs Designed
  with Effectiveness, Safety in Mind January 2004
•  http//uanews.opi.arizona.edu/cgi-bin/WebObjects/
  UANews.woa/5/wa/LQPStoryDetails?ArticleID8604

85
Examples of the Walkabout

• Veterinary Diagnostic Lab Integral to Risk
  Assessment March 2004
•  http//ali.opi.arizona.edu/cgi-bin/WebObjects/UAN
  ews.woa/5/wa/LQPStoryDetails?ArticleID8856
•  
• VP Research Highlights Excellence in UA Animal
  Hazards Program September 2004
•  http//ali.opi.arizona.edu/cgi-bin/WebObjects/UAN
  ews.woa/7/wa/LQPStoryDetails?ArticleID9759

86
Scenario 1The 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 do you do?
• How can this have been avoided?

Slide 21
87
Scenario 2The 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
88
Scenario 3The 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
89
Scenario 4The 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