Biosafety in the WorkplaceBiosafety in the WorkplacePLS 4/595D /Regulations and Laboratory ManagementSpring Semester, 2006Mark J. Grushka, M.S., CSPManager, Biosafety and BiosecurityUniversity of Arizona

Main Topics 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 Part 1 Introduction to Biological Safety PrinciplesSafety Principles

DefinitionsKey Principles Data on Laboratory Acquired InfectionsRisk Assessment Biosafety Containment LevelsPrimary Containment Emergency Preparedness

Introduction to Biosafety Introduction to Biosafety Principles 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

DefinitionsDefinitions

SafetyRiskBiosafetyBiosecurity

SafetySafety

Freedom from harmControl of accidental losses involving

– People– Property– Loss to process

RiskRisk

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

BiosafetyBiosafety

“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

BiosecurityBiosecurity

“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 PostulatesKoch’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 MaterialsBiohazardous 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 BiosafetyKey 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 Typical Routes of Entry for Viral or Bacterial Pathogensor Bacterial PathogensInhalationIngestionInjection

– Needle sticks– Accidental cuts with sharp objects

Skin or Eye Exposure

Laboratory Acquired InfectionsLaboratory 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 40 Years of Data on Overt LAI’sLAI’sPike, R.M. 1978 Various Classes of AgentsPike, R.M. 1978 Various Classes of Agents

Agent 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

Ten Most Frequently Reported Ten Most Frequently Reported LAI’sLAI’s Pike, R.M. 1978 Past and Present Hazards of AgentsPike, R.M. 1978 Past and Present Hazards of Agents

Infection No. of Cases No. of DeathsBrucellosis 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 ResponsibilitiesUniversity’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 Basic Risk Assessment FrameworkFrameworkHazard IdentificationEstimate Probability of OccurrenceDecide on Acceptable and Non-

Acceptable PracticesImplement PracticesMonitor

Example of Risk Assessment Example of Risk Assessment for Cell Culturefor Cell CultureBELGIAN BIOSAFETY SERVER 

http://www.biosafety.be/CU/animalcellcultures/mainpage.html – Introduction

Bioline International http://www.bioline.org.br/request?by95008

Risk Assessment Flow ChartRisk Assessment Flow Chart

Employee ResponsibilitiesEmployee 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 DefinedBiosafety Levels Defined

BSL-1 BSL-2 BSL-3 BSL-4

Biosafety Level One (BSL-1)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)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)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) Additional (BSL-3) RequirementsRequirementsImmunization and medical surveillance

protocols requiredNo open bench workDucted 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)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 BSC’s used by workers using one piece positive pressure personnel suits ventilated by a life support system

Identifying Biohazard RisksIdentifying 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 How to Protect Yourself

Knowledge and Understanding of the Biohazards You Are Working With

How Can it Get Onto/Into My BodyHow to Protect Myself (Hierarchy of

Control)– Containment Equipment– Techniques– Personal Protective Equipment

Identifying Biohazard Risk is Identifying Biohazard Risk is KeyKey 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 Mammalian Tissue Culture WorkWork 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 Class II Biological Safety Cabinets ExplainedCabinets 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 ContainmentBasis of Primary ContainmentIsolate the Laboratory Worker from Biological Agent With Isolate the Laboratory Worker from Biological Agent With Ultra Filtered Directional Air CurrentsUltra Filtered Directional Air Currents

Class II Type B1 Biological Class II Type B1 Biological Safety Cabinet Air Flow/HEPA Safety Cabinet Air Flow/HEPA Filter PlacementFilter Placement

Class II Type B1 Airflow Schematic

Exhaust

Intake

Proper Use of Biosafety Proper Use of Biosafety CabinetsCabinets 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 Proper Use of Biosafety CabinetsCabinets 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 Eagleston Institute Biosafety Cabinet ClipsCabinet Clips

What Does Your Lab Look What Does Your Lab Look Like? Advantages of Good Like? Advantages of Good HousekeepingHousekeeping 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 PreparednessEmergency 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 SpillsBiohazard 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

SummarySummary

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 FrameworkRegulatory Framework

PLS 4/595D /Regulations and Laboratory ManagementSpring Semester, 2006Mark J. Grushka, M.S., CSPManager, Biosafety and BiosecurityUniversity of Arizona

Part 2 Introduction to Part 2 Introduction to Introduction to Regulatory Introduction to Regulatory Framework 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?

IntroductionIntroduction

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 LawsFederal 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 HealthNational Institutes of Health

NIH Office of Biotechnology ActivitiesNIH Guidelines for Research Involving

Recombinant DNA Molecules IBC Resources

USDAUSDA

APHIS

USDOTUSDOT

HazMat Safety Hazardous Materials Regulations (49

CFR 100-185)

US EPAUS EPA

Hazardous Waste Microbiology IAQ

Select AgentsSelect 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 How is the UA Organized to Comply?Comply?Compliance based at Vice President for

Research OfficeManager of Biosafety and BiosecurityChairman of the Institutional Biosafety

CommitteeProgram Coordinator

UA and Regulatory Reality UA and Regulatory Reality CheckCheckInstitution Governed by Many Internal

Policies and External Laws/ Regulations– Provides a “Road Map” for Establishing and

Monitoring Effectiveness of Biosafety Program

– Keys to SuccessAccountability (Who is in Charge)Clear Goals and ObjectivesPeriodic Monitoring

Regulations and Guidelines for Regulations and Guidelines for Biosafety at UABiosafety 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 Institutional Biosafety Committee Requires a Written Committee Requires a Written Plan from PI for These Types Plan from PI for These Types of Research of Research

Recombinant DNAPathogenic MicroorganismsMammalian Cell LinesGene Therapy

Institutional Biosafety Institutional Biosafety Committee BasicsCommittee BasicsReports to Vice President for ResearchInsures 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 InformationWhere to Get More Information

(IBC Website) http://www.ibc.arizona.edu(Risk Management Website) http://www.

w3fp.arizona.edu/riskmgmthttp://cdc.govhttp://labor/osha.gov

Mark J. Grushka, Manager, Biosafety and Biosecurity 621-5279 and Margaret Stalker, Program Coordinator 621-3441

Criteria for ReviewCriteria for Review

Use of Pathogenic MaterialsUse of rDNA techniquesUse of Cell CultureTransgenic PlantsGene Therapy

Memorandum of Understanding Memorandum of Understanding and Agreement Formand Agreement FormIs the main risk assessment document

submitted by Principal InvestigatorsSubmitted in on-line formReviewed at least twice

– Prereview– Committee Review

Approval from IBC allows PI to conduct research at specific BSL level

Auditing FunctionAuditing 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 Other Resources

Training– Bloodborne Pathogen and Shipping of

Hazardous Materials by Air done by Risk Management and Safety

On-line UA Biosafety HandbookProgram Manager,Manager of Biosafety

and IBC Chair available to respond to technical or regulatory questions

Guidance DocumentsGuidance 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/bmbl4toc.htm

Part 3 Biosafety Program Part 3 Biosafety Program Management, Application of Management, Application of

Project Management Project Management Techniques and Case Studies Techniques and Case Studies

PLS 4/595D /Regulations and Laboratory ManagementSpring Semester, 2006Mark J. Grushka, M.S., CSPManager, Biosafety and BiosecurityUniversity of Arizona

How to Organize a Biosafety How to Organize a Biosafety Management ProgramManagement Program

GoalsElements Risk AssessmentTrainingMedical SurveillanceDocumentation

Slide2

GoalsGoals

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

ELEMENTS OF A BIOSAFETY ELEMENTS OF A BIOSAFETY PROGRAMPROGRAM

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 PROGRAMELEMENTS OF A BIOSAFETY PROGRAM Biosafety ManualBiosafety 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

RegistrationIdentify 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 ControlDocument Physical InventoryDocument Location of Infectious AgentsDocument Controls to be Used such as Biosafety Cabinets, special equipment (sealed centrifuge rotors, etc.)Document Assigned Responsible Individuals

ELEMENTS OF A BIOSAFETY PROGRAM

Registration and Inventory Control

Slide10

BIOHAZARD RISK ASSESSMENT

Identify Hazard

Biohazard identity/namee.g., Mycobacteruium tuberculosis, Brucella melitensis

Infectious to humansHumans are the primary host

Infectious to animalsAnimals are the primary host or reservoir of agent

Infectious for other living things in the environmentPlants, algae, insects

Slide11a

BIOHAZARD RISK ASSESSMENTBIOHAZARD RISK ASSESSMENT Quantify RiskQuantify 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 HostImmunocompromised because of drug therapy or illnessImmunocompromised due to a primary infection and therefore more susceptible to secondary opportunistic infections

What is the Availability of VaccineIs there a vaccine available against the biohazardous agentWhat is the protective factor of the vaccine (is it effective for 60%, 80% or 100% of all individuals)

What is the Availability of Drug TreatmentIs the biohazardous agent susceptible to antibiotic treatmentWhat 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 ASSESSMENTBIOHAZARD RISK ASSESSMENT Identify ControlsIdentify 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 ASSESSMENTBIOHAZARD RISK ASSESSMENT Identify ControlsIdentify 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 PROGRAMELEMENTS OF A BIOSAFETY PROGRAM Biosafety TrainingBiosafety 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

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

ELEMENTS OF A BIOSAFETY PROGRAM

Emergency Response

Slide 16

ELEMENTS OF A BIOSAFETY PROGRAMELEMENTS OF A BIOSAFETY PROGRAM Medical SurveillanceMedical 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 ProgramTypes 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 DocumentationRegistration Approval

Signed by the Investigator, the Department Director and the Biosafety Officer (Safety Coordinator)

Medical RecordsFor medical clearance, physicals, vaccinations, diagnostic test results, post-exposure evaluations, annual check-ups

Vaccination RecordsInclude declinations where appropriate

Date of vaccination, blood titers, booster requirements and completion of vaccination protocols

Training RecordsDocument initial training, supervisor training, refresher training

Include dates, trainer qualifications, course syllabus, sign-in sheet, method of evaluation (tests/quizzes), certificates issued

Auditing RecordsEnsure all inspections/audits are documented including actions taken

Slide 19

Documentation FrameworkDocumentation Framework

Policy

Standards AuditableMandatory Global Goal Orientated

Codes(Management Systems)

Should vs. ShallOther equivalentmeans allowed

Global PreferredApproach

Tech InfoSpecialistReference

Training SectorGuidance

MSDS ProductInfo

ToolsNot mandatoryunlessmandatedby Standard

AudienceSpecific

The Vice President for The Vice President for Research’s Walkabout for Research’s Walkabout for BiosafetyBiosafety 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 WalkaboutExamples 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/cgi-bin/WebObjects/UANews.woa/1/wa/

LQPStoryDetails?ArticleID=3922&wosid=UtPtDpXbJrhSbEVlsgCHxg VP Research Recognizes Three for Biosafety Excellence October 2001 http://uanews.opi.arizona.edu/cgi-bin/WebObjects/UANews.woa/wa/

MainStoryDetails?ArticleID=4384 VP Research Recognizes Biological Cabinet Maintenance Staff for

Biosafety ExcellenceJanuary 2002http://uanews.opi.arizona.edu/cgi-bin/WebObjects/UANews.woa/wa/

LQPStoryDetails?ArticleID=4796

Examples of the WalkaboutExamples of the WalkaboutSterling Parasitology Laboratories Recognized as a Model of Biosafety

Excellence April 2002 http://ali.opi.arizona.edu/cgi-bin/WebObjects/UANews.woa/1/wa/

LQPStoryDetails?ArticleID=5324&wosid=dFxhwGQJUxgVVczUhMKgq0 VP Research Recognizes UA Unit for Managing Hazardous WasteJuly 2002 http://uanews.opi.arizona.edu/cgi-bin/WebObjects/UANews.woa/1/wa/

LQPStoryDetails?ArticleID=5880&wosid=fUuz5a8K0ndElr2pg4xHgM

VP Research Recognizes Mirror Lab for Excellence in Health, Safety Leadership December 2002

http://uanews.opi.arizona.edu/cgi-bin/WebObjects/UANews.woa/5/wa/LQPStoryDetails?ArticleID=6521&wosid=CuIsRJGISTHGsQtpJ3cu30

  http://

Examples of the WalkaboutExamples of the Walkabout

VP Research Focuses Walkabout on Microbiology and Biosafety April 2003

 http://uanews.opi.arizona.edu/cgi-bin/WebObjects/UANews.woa/5/wa/

LQPStoryDetails?ArticleID=7225&wosid=gvjtwRNtmTIsrxIFWDDTig VP Research Recognizes Biosafety Excellence in Molecular Agriculture

Research October 2003 http://uanews.org/cgi-bin/WebObjects/UANews.woa/wa/MainStoryDetails?

ArticleID=8103. 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?ArticleID=8604

Examples of the WalkaboutExamples of the Walkabout

Veterinary Diagnostic Lab Integral to Risk Assessment March 2004

 http://ali.opi.arizona.edu/cgi-bin/WebObjects/UANews.woa/5/wa/LQPStoryDetails?ArticleID=8856

 VP Research Highlights Excellence in UA

Animal Hazards Program September 2004 http://ali.opi.arizona.edu/cgi-bin/WebObjects/

UANews.woa/7/wa/LQPStoryDetails?ArticleID=9759

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?

Scenario 1:Scenario 1:

The Dedicated Post-DocThe Dedicated Post-Doc

Slide 21

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?

Scenario 2:Scenario 2:

The Helpful Lab WorkerThe Helpful Lab Worker

Slide 22

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?

Scenario 3:Scenario 3:

The Reluctant DirectorThe Reluctant Director

Slide 23

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?

Scenario 4:Scenario 4:

The Busy ScientistThe Busy Scientist

Slide 24