Main Topics. Biosafety in the Workplace. Introduction to Biosafety Principles. Historical Perspective. Biosafety. Biosecurity

Transcription

1 Biosafety in the Workplace PLS 4/595D /Regulations and Laboratory Management Spring Semester, 2008 Mark J. Grushka, M.S., CSP Manager, Biosafety and Biosecurity University of Arizona Main Topics Introduction to Biological Safety Principles Introduction to Regulatory Framework Biosafety Program and Project Management 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 Historical Perspective 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 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 Mark Grushka 1

2 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. Core 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 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 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 Lab Techniques Personal Protective Equipment Mark Grushka 2

3 University s 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 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. 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 Class II Type B1 Biological Safety Cabinet Air Flow/HEPA Filter Placement Class II Type B1 Airflow Schematic Intake Exhaust Eagleston Institute Biosafety Cabinet Clips Summary Risks of Working with Biological Materials in Research are Real The Risks Can be Managed Through: Properly Identifying and Assessing Biological Risks Facility Design, Construction and Maintenance (Secondary Barriers) Correct Use of Safety Equipment (Primary Barriers) Including Biological Safety Cabinets Good Laboratory Practice and Technique Additional Resources are Available Through Institutional Biosafety Committee and Professional Staff Mark Grushka 3

4 Regulatory Framework PLS 4/595D /Regulations and Laboratory Management Spring Semester, 2008 Mark J. Grushka, M.S., CSP Manager, Biosafety and Biosecurity University of Arizona 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 Examples of Federal Labor Laws Occupational Health and Safety Act (OSHAct) Bloodborne Pathogens (29 CFR ) Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR ) Personal Protective Equipment (29 CFR ) Needlestick Standard Examples of Federal Biotechnology Guidelines NIH Office of Biotechnology Activities NIH Guidelines for Research Involving Recombinant DNA Molecules IBC Resources Biosafety in Microbiological and Biomedical Laboratories Other Federal Regulatory Agencies USDA USDOT EPA Mark Grushka 4

5 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 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 Institutional Biosafety Committee Requires a Written Plan from PI for These Types of Research Recombinant DNA Pathogenic Microorganisms Mammalian Cell Lines Gene Therapy Transgenic Plants 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 MUA New User Profile: Administrative and Emergency Information SECTION 1: Project Information Mark Grushka 5

6 Where to Get More Information IBC Website Risk Management CDC Website OSHA Websitehttp://labor/osha.gov Mark J. Grushka, Manager, Biosafety and Biosecurity and Margaret Stalker, Program Coordinator Guidance Documents World Health Organization Biosafety Manual WHO_CDS_CSR_LYO_2004_11/en/ 2nd Edition Primary Containment for Biohazards:Selection, Installation and Use of Biological Safety Cabinets Biosafety in Microbiological and Biomedical Laboratories (BMBL) 4th Edition toc.htm American Biological Safety Association (ABSA) Regulatory Summary Compliance Environment Characteristics Combination of laws, regulations and guidance documents Objective is to reduce chance of impact of biological research on occupational health, public health and environmental impacts Institution has significant autonomy in terms of defining how biosafety is organized to meet compliance objectives Part 3 Biosafety Program Management, Application of Project Management Techniques and Case Studies PLS 4/595D /Regulations and Laboratory Management Spring Semester, 2008 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 Mark Grushka 6

7 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 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 Biosafety Manual BIOHAZARD RISK ASSESSMENT Quantify Risk 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 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 Slide9 Slide 11b Hierarchy of Controls BIOHAZARD RISK ASSESSMENT Identify 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 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 12a Slide 12b Mark Grushka 7

8 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 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 15 Slide 16 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 Types of Audits/Inspections Auditing Program 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 Mandatory Other equivalent means allowed Not mandatory unless mandated by Standard Documentation Framework Global Goal Orientated Global Preferred Approach Audience Specific Tech Info Specialist Reference Policy Standards Codes (Management Systems) Training Sector MSDS Guidance Auditable Should vs. Shall Product Info Tools The Vice President for Research s 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. Mark Grushka 8

9 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? Scenario 1: The Dedicated Post-Doc How can this have been avoided? 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? Scenario 2: The Busy Scientist How can you convince him of the need to attend training? How can this have been avoided? Slide 21 Slide 24 Biosafety Project Management PLS4/595D Spring 2008 Basic Ingredients of Projects Major Drivers Time Money People Risks What are risks to business? (research $, reputation, liability issues) What are the risks to people (LAI s, environmental impact) Basic Elements of Biosafety Project Management Project Charter Sponsor Customer expectations Scope of work Working as a Team Who needs to be there? What is each team member responsible for? Establish timeline Doing the Project How will you keep track of progress? Closing Out the Project Documentation Final Reports to Customer Lessons Learned Project Background You have been appointed as Project Manager for Biosafety at a large (and prestigious) academic research institution. The institution has used BSL-1 microorganisms in the past, but now the Vice President for Research wishes to apply for NIH funding to do work with Cryptosporidium and Coccidioides immitis. These agents will require a higher level of containment. You have been given a generous budget and can select team members to get the project done. Mark Grushka 9

10 Project Deliverables Using the Project Management Model, briefly identify what you will need to do in order to develop a formal biosafety management program for BSL-2 agents, including Select Agents. Consider such core areas as risk assessment of the pathogens, lab design including ventilation, training, monitoring of the biosafety performance and resources. What regulations/guidelines must you consider? What will success look like for you in this project? Mark Grushka 10