Facilities & Safety: Biosafety and Biosecurity. Presented By: Zibusiso M. Masuku

Transcription

1 Facilities & Safety: Biosafety and Biosecurity Presented By: Zibusiso M. Masuku

2 Welcome Welcome to the Facilities & Safety: Biosafety and Bio Security Module 2

3 Module Outline Facilities & Safety Biosafety and biosecurity Biorisk Management The main elements of biosafety Risk assessment defined Biosafety level requirements Develop laboratory floor plans exercise Wrap-up

4 Module Objectives At the end of this module, participants will be able to: Be familiar with the drivers of safety in the laboratory; Be familiar with the general safety requirements for the laboratory; Understand the concept of biosafety and biosecurity (as elements of Biorisk Management), and describe the main elements in biocontainment; Identify the differences between biosafety levels 1-4, and understand the criteria and requirements for determining the appropriate biosafety; Understand the different laboratory equipment used in biocontainment facilities.

5 Activity: Pre-Presentation Questionnaire Instructions: Individually, complete the Pre-Presentation Questionnaire in your guide. Take 5 minutes

6 Facility & Safety Overview The primary objective is for laboratory facilities to be safe, and an accessible environment for personnel to conduct their work. The key is to reduce injury and/or illness. Minimise hazards. To ensure quality of work Legal requirements.

7 Safety Institution: Oversight & Enforcement Laboratory safety drivers compliance to legislation and regulations; quality standards and for accreditation. Examples of these include the following: Occupational Health and Safety Act 85 of Regulations for Hazardous Biological Agents Clinical Laboratory Standards Institute (CLSI formally NCCLS). ISO15189:2012 Checklist For Medical Laboratories (SANAS accreditation). WHO Laboratory Assessment Toolkit.

8 Roles and Responsibilities These should be clearly defined for the entire institute: Management Laboratory personnel Committees, e.g. Safety Committee Support services

9 General Requirements for Laboratories To ensure the safety of personnel (including the environment) and the quality of work, the following requirements have to be met: Administrative controls including Good Lab Practices (GLP), SOP s, and accident management plans; Engineering controls - building and laboratory design considerations (e.g. controlled ventilation systems); Safety Equipment and PPE must be appropriate for tasks General lab safety procedures including physical, biohazard, fire, chemical and electrical safety Waste management/handling procedures treatment and disposal (from cradle-to-grave ). Ref: Mycobacteriology Laboratory Manual, 1st Edition, 2014

10 Standard Safety Practices NO IN LABORATORY

11 Standard Safety Practices (continued ) YES IN LABORATORY

12 Standard Safety Practices (continued ) Waste Management Fire and Evacuation Drills Safety Signs Use separate waste containers (usually colour coded) for all potentially harmful and dangerous materials. Monthly and yearly exercises must be organized for fire drills and laboratory evacuation procedures. Warning and instruction labels must be visible. YES IN LABORATORY

13 Documentation Risk Assessment and Hazard Identification. Laboratory Safety Manual. Records of (but not limited to): Staff training Equipment servicing Equipment calibration

14 Identification of Risks Risks in laboratories may be numerous and laboratory workers encounter these risks. A Risk assessment is compulsory for the laboratory director in order to manage and reduce risks to laboratory employees. Safety procedures explaining what to do in case of accidents, injuries and contamination need to be written, staff must be trained and have easy access to all procedures. Record of staff exposures to hazards, actions taken when this occurs, and procedures put into place must be maintained so as to prevent future occurrences.

15 Laboratory Hazards Physical Chemical Biological

16 Physical and Biological Hazards Physical Hazards: Handling equipment and poor maintenance Biological Hazards: Aerosols and droplets are the main sources of contamination Image: WHO: Training Toolkit

17 Chemical Hazards Separate cabinets for storage: Spill containment cabinet Hazardous waste storage Flammable liquids storage

18 Biosafety & Biosecurity in Laboratories Levels 1-4

19 What is Biosafety? The prevention of exposures, occupationally acquired infections, and release of organisms to the environment by laboratory workers in the biomedical environment. The fundamental objective being the containment of the potentially harmful agents.

20 Elements of Biosafety Standard microbiological practices Special practices Safety equipment (Primary Containment Barriers) Laboratory facilities (Secondary Containment Barriers)

21 What is Biosecurity? The protection of pathogens, toxins, and sensitive information from loss, theft and subsequent misuse.

22 Bio-risk The risk associated with biological materials in the laboratory Bio-risk encompasses biosafety and biosecurity CWA outlines a comprehensive, international bio-risk management system framework

23 What is Bio-containment? Describes safe methods, facilities and equipment for managing infectious agents in the laboratory Purpose is to reduce or eliminate exposure of laboratory workers and outside environment to potentially hazardous agents

24 Elements of Biocontainment The proper mix of the three elements is assessed by the needs and specific hazards of the facility Practices and Procedures Plus Occupational Health Safety Equipment Facility Design

25 Containment Barriers Primary barriers (safety equipment) BSCs- all procedures Personal Protective Equipment (PPE) Isolators and Ventilated Racks Secondary barriers (facilities) Design parameters to protect people surrounding the laboratory and the community Separate building or isolated zone Special HVAC systems and controls

26 Achieving Containment Strategies Using Inward directional airflow Isolation dampers Sealing service penetrations Backflow prevention Filtration Standard Operating Procedures Primary Containment Ante Rm Lab BSC Sterilizer Secondary Containment

27 Laboratory Equipment Biological Safety Cabinet (BSC) Autoclaves Isolators Ventilated Cages Transfer Chambers Dunk Tanks Sinks

28 Safety Equipment Personal Protective Equipment (PPE)

29 Safety Equipment (continued ) Waste disposal and safety cabinets

30 Safety Equipment (continued ) Biological Safety Cabinets (BSCs) Primary means of containment Three (3) design types: Class I, Class II, and Class III Designed to provide protection for: Personnel Directional flow of air into cabinet Environment HEPA filtered exhaust Product (except for Class I) Laminar flow of HEPA filtered air

31 Safety Equipment (continued ) Types of Biological Safety Cabinets Class I BSC Class II BSC Class III BSC

32 Establishing BSL/ ABSL Levels Performing a Risk Assessment The foundation of Biosafety and the basis for BSLs Perform a comprehensive hazard evaluation of the hazard posed by the infectious agent Determine additional safety enhancements based on the laboratory functions or activities *N.B. The same risk assessment process can be followed when establishing ABSL facility levels

33 Risk Groups *Biosafety in Microbiological and Biomedical Laboratories, 5 th Edition

34 Risk Groups vs Biosafety Levels Relation of risk group to biosafety levels, practices and equipment *Laboratory Biosafety Manual, 3 rd Edition

35 Biosafety level requirements Summary of biosafety level requirements *Laboratory Biosafety Manual, 3 rd Edition

36 BSL-1 Agents not known to cause disease (Bacillus subtilis, infectious canine hepatitis) Utilize Standard Microbiological Procedures No Special Practices required Areas not separated from other areas

37 BSL-1 Laboratory Hand washing sink Windows with fly screens Fume hoods Signage

38 BSL-2 Agents associated with human disease (Hepatitis B virus, Salmonella spp.) Work involving agents that pose moderate hazards to personnel and the environment Personnel are trained to handle pathogens Restricted access while in operation Aerosol or splash-producing procedures are conducted in containment equipment

39 BSL-2 (continued ) In addition to BSL-1 requirements: Site-Specific Biosafety manual with Standard Operating Procedures (include spill response and emergency procedures) Autoclave available Minimize procedures that cause splashes/aerosol formation Transport of materials in special containers

40 BSL-2 Laboratory

41 BSL-3 Laboratories Designed for Risk Group 3 micro organisms: May be transmitted by the airborne route, indigenous/exotic agents associated with human disease Often have a low infectious dose to produce effects Can cause serious or life-threatening disease Yellow fever virus, Hantaan virus, TB

42 BSL-3 Laboratories (continued ) In Addition to BSL-2 requirements: Hands-free sink Restrict the use of sharps and glass Wrap-around/solid-front gown, head covering and possibly shoe covers Eye protection and possibly respiratory protection is worn Decontaminate solid materials/waste prior to removal from the lab

43 BSL-3 Laboratories (continued ) Additional primary and secondary barriers to minimize the release of infectious organisms Additional features to prevent transmission of BSL3 organisms: Appropriate respiratory protection HEPA filtration of exhausted laboratory air Strictly controlled laboratory access

44 BSL-3 Laboratories (continued ) BSL-3 Laboratory Physically separate from access corridors Self-closing double door Exhausted air is not re-circulated Negative airflow into laboratory

45 BSL-3 Laboratories (continued ) BSL3 Laboratory: Layout Option A *Public Health Agency Canada

46 BSL-3 Facility Design Segregation from public access Eyewash station Sink for handwashing Ventilation systems critical

47 BSL-3 Facility Design (continued ) Slip-resistant floors Bench tops should be impervious to water and resistant to disinfectants, acids, alkalis, organic solvents and moderate heat Walls, ceilings, floors and furniture should be easy to clean

48 BSL-3 Facility Design (continued ) Physical Laboratory Design Directional inward airflow Z.M. Masuku Pressure monitoring devices at entry

49 BSL-3 Facility Design (continued ) Physical Laboratory Design Controlled access Antechamber equipped with clean/dirty change and body shower Interlocking entry doors Alarms for HVAC failure (indication devices in laboratory space) Decontamination dunk tank, pass through box

50 BSL-3 Facility Design (continued ) Physical Laboratory Design Exhaust air HEPA filtered Backflow prevention on supply air (bubbletight dampers) Directional airflow

51 BSL-3 Facility Design (continued ) Physical Laboratory Design Solid & Effluent Waste Sterilisation Autoclave in laboratory (barrier design) Kill Tanks

52 BSL-4 Laboratories Designed for Risk Group 4 micro organisms: Dangerous/exotic agents and high risk of life threatening nature, transmitted by aerosol or transmission unknown All work done in a class III & II cabinet or positive pressure personnel suit Facility is separated from other work areas Access is strictly control Lassa fever virus, Ebola virus, Marburg virus, Rift Valley Fever, smallpox

53 BSL-4 Laboratories (continued ) In Addition to BSL-3 requirements: The Sign-in procedures to monitor personnel Clothing change before entering Shower upon exiting All material is decontaminated Other requirements as required by the risk assessment

54 BSL-4 Laboratories (continued ) BSL-4 Design Special engineering and design features to prevent microorganism from escaping into environment Overheard floor(s) contain ventilation systems with HEPA-filtered supply and exhaust Underlying floor(s) - contain plumbing and effluent collection / treatment system Laboratory entrance and exit through: Clean change room, personal shower, dirty change room, suit Chemical shower room, enter laboratory More strict access control (e.g., 24-hour guard and check logbooks) in/out

55 BSL-4 Laboratories (continued ) BSL-4 Laboratory Suit Laboratory

56 BSL-4 Laboratories (continued ) BSL-4 Laboratory Cabinet Laboratory

57 BSL-4 Laboratories (continued ) BSL-4 Laboratory

58 BSL-4 Laboratories (continued ) Laboratory Facilities Work in positive pressure suits Bioseal submarine doors Antechamber with suit room and chemical decontamination shower

59 BSL-4 Laboratories (continued ) Physical Laboratory Design Double Exhaust HEPA Exhaust HVAC system Plumbing Vent Vacuum Lines Supply HVAC System (Single HEPA)

60 Verification of Biosafety Level 3 & 4 Laboratory Facilities It is recommended that BSL-3 and BSL-4 lab design and operation be recertified, at least annually, to verify the design and operational parameters.

61 Activity: Laboratory Planning Exercise Group Exercise Instructions: In your groups read through the Laboratory Planning Exercise scenario write-up. Develop a laboratory layout diagram for the equipment provided and present to the class. Take 40 minutes

62 Activity: Post-Presentation Questionnaire Instructions: Individually, complete the Post-Presentation Questionnaire in your guide. Take 5 minutes

63 Summary & Key Messages When designing a laboratory or organizing workflow, ensure that patients and patient samples do not have common pathways. Safety is dependent on: A responsible supervisor A safety manual and sops Trained personnel Assessment of risks Laboratory design Neglecting laboratory safety is costly, as the lives and health of employees and patients, laboratory reputation, equipment, and facilities are put at risk.

64 Summary & Key Messages (continued ) Biosafety (prevention of the unintentional exposure to pathogens) and Biosecurity (prevention of the intentional release of pathogens) are both elements of Biorisk (risks associated with biological materials) The main elements of biosafety are standard microbiological practices, special practices, safety equipment and facility design and construction Risk assessment is the foundation and basis of BSLs and involves a comprehensive hazard evaluation of the hazard posed by the infectious agent

65 Acknowledgements The presentation on Biosafety and Biosecurity is modeled in part around the Define Biosafety & Biosafety Levels 1-4 module of the ACILT Strengthening Biosafety and Biosecurity course. This presentation was developed with the assistance of Mr. Ken Ugwu, P.Eng, Public Health Agency of Canada. Global Biorisk Management Curriculum (GBRMC) courses used for reference material. The Centre for Emerging and Zoonotic Diseases (CEZD) 65

66 Guidelines & Standards

67 References References Laboratory Biosafety Manual, 3 rd Edition Biosafety in Microbiological and Biomedical Laboratories, 5 th Edition Laboratory Biosafety Guidelines, 3rd Edition Canadian Biosafety Standards and Guidelines, 1 st Edition; WHO TB Laboratory Safety Manual, 2012 ANSI/ASSE Z : Testing and Performance-Verification Methodologies for Ventilation Systems for BSL3 and ABSL3 Facilities, 2014 The National Institutes of Health (NIH) Design Requirements Manual for Biomedical Laboratories and Animal Research Facilities (DRM), 2008 CWA 15793: Laboratory Biorisk Management Standard;

68 Wrap Up Participants are now be able to: Explain general safety requirements for the laboratory; Discuss the concept of biosafety and biosecurity (as elements of Bio-risk Management); Describe the main elements in bio-containment; Identify the differences between biosafety levels 1-4 and discuss the classification of existing and planned facilities ; Describe the criteria and requirements for determining the appropriate biosafety; Discuss the different laboratory equipment used in bio-containment facilities; Describe the selection of PPE and laboratory equipment;

69 Questions