Biosafety and Biosecurity PDF

INTENDED LEARNING OUTCOMES AT THE END OF THE LESSON, THE STUDENTS SHOULD BE ABLE TO: 1. DISCUSS THE HISTORY AND THE RELATED POLICIES AND GUIDELINES GOVERNING LABORATORY BIOSAFETY AND BIOSECURITY; 2. DIFFERENTIATE THE FUNDAMENTAL CONCEPTS BETWEEN LABORATORY BIOSAFETY AND BIOSECURITY; 3. E...

INTENDED LEARNING OUTCOMES AT THE END OF THE LESSON, THE STUDENTS SHOULD BE ABLE TO: 1. DISCUSS THE HISTORY AND THE RELATED POLICIES AND GUIDELINES GOVERNING LABORATORY BIOSAFETY AND BIOSECURITY; 2. DIFFERENTIATE THE FUNDAMENTAL CONCEPTS BETWEEN LABORATORY BIOSAFETY AND BIOSECURITY; 3. EXPLAIN THE DIFFERENT LOCAL AND INTERNATIONAL ORGANIZATIONS OF BIOSAFETY; 4. CLASSIFY MICROORGANISMS ACCORDING TO THEIR RISK GROUP; AND 5. CATEGORIZE LABORATORIES ACCORDING TO THEIR BIOSAFETY LEVEL. 2 3 ▪ CONTAINMENT PRINCIPLES, TECHNOLOGIES AND PRACTICES IMPLEMENTED TO PREVENT UNINTENTIONAL EXPOSURE TO PATHOGENS AND TOXINS, OR THEIR UNINTENTIONAL RELEASE  BIOSAFETY “PROTECT THE WORKER FROM THE BAD BUGS.” 5 Bacterial outbreak in China infects thousands of people after factory leak -ET Healthworld.com Beijing, September 18 (ANI): Several thousand people in north-east China have tested positive for a bacterial disease in an outbreak caused by a leak at a biopharmaceutical company last year, authorities said on Tuesday. The Health Commission of Lanzhou, the capital city of Gansu province, announced that 3,245 people had contracted the disease brucellosis. The disease is often caused by contact with livestock carrying the bacteria brucella, CNN reported. This outbreak began from a leak at the Zhongmu Lanzhou biological pharmaceutical factory, which occurred between late July to late August last year, according to the city's Health Commission. Another 1,1401 people have also tested positive of the disease but there have been no fatalities have been reported, the city's Health Commission said. In total, authorities have tested 21,847 people out of the city's 2.9 million population. 6 ▪ PROTECTION, CONTROL AND ACCOUNTABILITY FOR VALUABLE BIOLOGICAL MATERIALS WITHIN LABORATORIES IN ORDER TO PREVENT UNAUTHORIZED ACCESS, LOSS, THEFT, MISUSE, DIVERSION OR INTENTIONAL RELEASE  BIOSECURITY “PROTECT THE BUGS FROM BAD WORKERS”. 8 9  CHAIN OF INFECTION 10 LABORATORY ACQUIRED INFECTIONS ▪ INFECTIONS (SYMPTOMATIC / ASYMPTOMATIC) ▪ ACQUIRED THROUGH LABORATORY RELATED ACTIVITIES AS A RESULT OF WORKING WITH INFECTIOUS AGENTS 12 ▪ CAUSATIVE OR DEFINED EVENT □ 20% → EQUIPMENT FAILURE □ 80% → HUMAN FACTORS 13 14 ▪ TOP ACCIDENTS RESULTING IN INFECTION 15 ▪ INGESTION □ CONSUMPTION OF A SUBSTANCE BY AN ORGANISM ▪ INOCULATION □ ACT OF INTRODUCTION OF A SUBSTANCE INTO THE BODY 16 ▪ CONTAMINATION □ PRESENCE OF A MINOR AND UNWANTED SUBSTANCE OR IMPURITY IN THE SKIN OR MUCOUS MEMBRANE ▪ INHALATION □ ACT OF DRAWING AIR OR OTHER SUBSTANCES INTO THE LUNGS 17 HISTORY OF BIOSAFETY 18 A.G. Wedum, MD U.S. Biological Research Laboratories at Fort Detrick one of the pioneers in developing biosafety measures after the Second World War evaluated the risks of handling hazardous biological agents and developed practices, equipment, and facility safeguards for their control A.G. Wedum Asilomar Conference in 1975 general principles for dealing with potential biohazards related to GMOs were drafted It was suggested that containment should be an essential consideration in the experimental design and that the effectiveness of the containment should match the estimated risk. mid-1970s designation of 4 levels of biosafety 1976 first edition of the National Institutes of Health (NIH) guidelines for research involving DNA molecules was published 1984 first edition of a guidebook, called Biosafety in Microbiological and Biomedical Laboratories was produced U.S. NIH and Centers for Disease Control and Prevention (CDC) now considered a major reference text for biosafety 1990 Directive on the protection of workers from risks related to exposure to biological agents at work (European Commission) Directive on the contained use of genetically modified microorganisms(European Commission) ORGANIZATIONS  provides oversight of public health and safety, including the laboratory Develops and enforces workplace standards to protect employees’ safety and health. Recommendations include guidelines addressing blood-borne pathogens, chemical safety, phlebotomies, latex gloves, ergonomics, and any other potentially hazardous situation that may be found in the workplace 27 International Federation of Biosafety Associations 28 29 FUNDAMENTAL CONCEPTS ▪ LABORATORY SAFETY ▪ BLOOD BORNE PATHOGENS ▪ RECOMBINANT DNA ▪ BIOLOGICAL WASTE DISPOSAL ▪ TRANSPORT OF BIOLOGICAL MATERIALS 31 ▪ RESPIRATORY PROTECTION ▪ BIOTERRORISM AND SELECT AGENTS ▪ MOLD AND INDOOR AIR QUALITY ▪ OCCUPATIONAL SAFETY ▪ HEALTH IN THE USE OF RESEARCH ANIMALS 32 ▪ THE PRINCIPLE OF HOLDING OR BE CAPABLE OF HOLDING OR INCLUDING WITHIN A FIXED LIMIT OR AREA ▪ BIOCONTAINMENT: PREVENTING THE RELEASE OF BIOLOGICAL AGENTS 33  PRIMARY BARRIERS (control hazard at source) BSC HEPA filter BSC SECONDARY BARRIERS (structure surrounding primary barrier) Sealed perimeter Exhaust HEPA filters 34 ▪ PRIMARY CONTAINMENT EQUIPMENT □ BSC □ ANIMAL ENCLOSURES □ SEALED CENTRIFUGE ROTORS 35 ▪ HEPA FILTERS ▪ LIQUID EFFLUENT TREATMENT ▪ SEALED LABORATORY WALLS AND FLOORS 36 LAMINAR FLOW HOOD 37 HEPA FILTER 38 ▪ PRACTICE AND PROCEDURES □ STANDARD PRACTICES □ SPECIAL PRACTICES AND CONSIDERATIONS ▪ SAFETY EQUIPMENT ▪ FACILITY DESIGN AND CONSTRUCTION ▪ INCREASING LEVELS OF PROTECTION 39  1 ▪ MOST IMPORTANT CONCEPT / STRICT ADHERENCE ▪ AWARE OF POTENTIAL HAZARD ▪ TRAINED AND PROFICIENT IN TECHNIQUES 40  2 ▪ PRIMARY CONTAINMENT BARRIER ▪ MINIMIZE EXPOSURE TO HAZARD □ ENGINEERING CONTROLS / EQUIPMENT □ PPE □ BIOLOGICAL SAFETY CABINETS 41 42 ▪ LAB COATS AND GOWNS □ USED TO PROTECT FROM INFECTIOUS FLUIDS □ DON’T WEAR LAB COATS OUTSIDE OF THE LAB OR TAKE THEM HOME □ CUFFED SLEEVES CAN PROTECT THE WRISTS AND LOWER ARMS 43 ▪ GLOVES □ WEAR DISPOSABLE VINYL, SYNTHETIC OR N-DEX NITRILE GLOVES WHEN WORKING WITH BIOHAZARDOUS MATERIALS 44 ▪ GLOVES □ AVOID LATEX GLOVES (MAY CAUSE ALLERGIES) □ DO NOT REUSE GLOVES □ DO NOT WEAR GLOVES OUTSIDE OF THE LABORATORY □ WASH HANDS AFTER REMOVING GLOVES 45 ▪ EYE AND FACE PROTECTION □ PROTECT MUCOUS MEMBRANES AND PREVENT INGESTION WHENEVER THERE IS POTENTIAL FOR SPLASH TO EYES/FACE 46 ▪ FOOT/SKIN PROTECTION □ OPEN TOED SHOES, SANDALS AND OTHER OPEN FOOTWEAR SHOULD BE PROHIBITED □ SHORTS AND OTHER GARMENTS THAT LEAVE SKIN UNPROTECTED ARE NOT APPROPRIATE 47 ▪ RESPIRATORY PROTECTION □ TWO TYPES: AIR SUPPLYING AND AIR PURIFYING □ FULL FACE, HALF FACE, PAPR (POWERED AIR PURIFYING RESPIRATOR) 48 ▪ RESPIRATORY PROTECTION □ N95 RESPIRATORS □ N100 RESPIRATORS 49 ▪ BSCS PROVIDE EFFECTIVE PRIMARY CONTAINMENT FOR WORK WITH INFECTIOUS MATERIAL OR TOXINS WHEN THEY ARE PROPERLY MAINTAINED AND USED IN CONJUNCTION WITH GOOD LABORATORY TECHNIQUES 50 51 52 53 54 ▪ REMOVES A BROAD RANGE –SOOT OF AIRBORNE –POLLEN CONTAMINANTS: –RADIOACTIVE PARTICLES –FINE DUST –IMPURITY ION →CAN AFFECT –SMOKE INTEGRATED CIRCUIT SPEED –BACTERIA (TYPICAL SIZE: 500 TO 0.3ΜM 55 56 ANNUAL BSC TESTING HEPA FILTER LEAK TEST INFLOW VELOCITY TEST DOWNFLOW VELOCITY TEST AIRFLOW PATTERN TEST 57  3 ▪ SECONDARY BARRIERS / ENGINEERING CONTROLS □ CONTRIBUTES TO WORKER PROTECTION □ PROTECTS OUTSIDE THE LABORATORY 58  3 ▪ EXAMPLE: □ BUILDING AND LAB DESIGN □ VENTILATION □ AUTOCLAVE □ CAGE WASH FACILITIES 59 3 60  4 ▪ BIOSAFETY LEVELS □ INCREASING LEVELS OF EMPLOYEE AND ENVIRONMENTAL PROTECTION □ GUIDELINES FOR WORKING SAFELY IN RESEARCH AND CLINICAL LABORATORY 61 CLASSIFICATION OF INFECTIVE MICROORGANISMS BY RISK GROUP ▪ ASSIGNMENT OF MICROORGANISMS BASED ON: □ PATHOGENICITY □ MODE OF TRANSMISSION AND HOST RANGE □ LOCAL AVAILABILITY OF EFFECTIVE PREVENTATIVE MEASURES □ LOCAL AVAILABILITY OF EFFECTIVE TREATMENT Risk A microorganism that is unlikely to cause human or Group 1 animal disease. BSL 1 Typical Open bench Work Area Example S. cerevisiae (yeast), Lactobacillus, B. subtilis 64 Risk A pathogen that can cause human or animal disease Group 2 but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited. BSL 2 Typical Biosafety cabinet / laminar flow hood Work Area 65 Risk Group 2 BSL 2 Example Hepatitis B virus, HIV, the salmonellae and Toxoplasma spp. 66 Risk A pathogen that usually causes serious human or Group 3 animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available. BSL 3 Typical Class 3 biosafety cabinet Work Area Example M. tuberculosis, St. Louis encephalitis virus and 67pestis, SARS virus Coxiella burnetti, Yersinia Risk Group 4 68 Risk A pathogen that usually causes serious human or Group 4 animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available. BSL 4 Typical Full isolation suits Work Area Example Ebola, Marburg or Congo-Crimean hemorrhagic fever viruses 69 70 ▪ COMBINATION OF LABORATORY PRACTICES AND PROCEDURES, SAFETY EQUIPMENT (PRIMARY BARRIERS) AND LABORATORY FACILITIES (SECONDARY BARRIERS) □ SOMEWHAT RELATED TO RISK GROUPS 71 ▪ FOR RISK GROUP 1 ▪ SAFETY PRACTICES: □ RESTRICT OR LIMIT ACCESS WHEN WORKING. □ PROHIBIT EATING, DRINKING, AND SMOKING. □ PROHIBIT MOUTH PIPETTING. □ NEEDLES AND SHARPS PRECAUTIONS ▪ BASIC LEVEL OF CONTAINMENT 72 73 ▪ FOR RISK GROUP 2 ▪ SAFETY PRACTICES: □ BSL-1 PRACTICES PLUS: □ USE BIOLOGICAL SAFETY CABINET (BSC)-CLASS II □ USE LEAKPROOF CONTAINERS ▪ CLINICAL, DIAGNOSTIC, TEACHING AND OTHER LABORATORIES ▪ SPLASHES OR AEROSOLS IS LOW 74 75 ▪ FOR RISK GROUP 3 ▪ SAFETY PRACTICES: □ BSL-2 PRACTICES PLUS: □ USE BSC-CLASS II 100% AIR EXHAUSTED TO OUTSIDE THROUGH DOUBLE HEPA FILTRATION OR HEPA PLUS INCINERATION. □ CABINET IS GAS TIGHT AND SEALED, WITH OPERATION PERFORMED THROUGH RUBBER GLOVES. □ USE COMPLETE PPE (PERSONAL PROTECTIVE EQUIPMENT). 76 ▪ FOR AGENTS THAT POSE AN INCREASED RISK OF AEROSOL SPREAD ▪ MORE EMPHASIS ON PRIMARY AND SECONDARY BARRIERS ▪ CONTROLLED ACCESS TO THE LABORATORY AND VENTILATION REQUIREMENTS ▪ ALL LABORATORY MANIPULATIONS ARE PERFORMED IN A BSC 77 78 ▪ FOR RISK GROUP 4 ▪ DANGEROUS AND EXOTIC AGENTS ▪ TRANSMITTED VIA AEROSOL ROUTE ▪ MAXIMUM CONTAINMENT ▪ CLASS III BSC ▪ SUIT LABORATORY 79 80 BIOSECURITY 81 ▪ BIOLOGICAL MATERIALS ▪ NO DEVICES TO DETECT PATHOGENS BEING REMOVED FROM FACILITY ▪ EASY TO HIDE SMALL VIALS, FILTER PAPER ▪ PRESENT IN CLINICAL LABS, RESEARCH LABS, PRIVATE LABS AND GOVERNMENT LABS 1. PHYSICAL SECURITY 2. PERSONNEL SECURITY 3. PATHOGEN SECURITY 4. TRANSPORT SECURITY 5. INFORMATION SECURITY  Physical security Access control Intrusion detection Alarm assessment and response Information security Personnel Security Confidentiality, integrity and availability Background check of info Periodic investigations Passwords, back-ups Personnel reliability program Transport security Pathogen security 3 way packaging system Detailed inventory “From – How – Where” Internal / external transfer Knowledge IATA certified personnel Inactivation and disposal records of 84 pathogens Effectiveness of biosecurity will depend on the integrity of the individuals with access to the pathogen. Thank you for your kind attention! 85