Basic Concepts On Laboratory Biosafety And Biosecurity - PDF

BASIC CONCEPTS ON LABORATORY BIOSAFETY AND BIOSECURITY PRINCIPLES OF MEDICAL LABORATORY SCIENCE PRACTICE 1(MLSPRAC1) September 25, 2024 LEARNING OUTCOMES At the end of the discussion, the students should be able to: 1.Discuss the history and th...

BASIC CONCEPTS ON LABORATORY BIOSAFETY AND BIOSECURITY PRINCIPLES OF MEDICAL LABORATORY SCIENCE PRACTICE 1(MLSPRAC1) September 25, 2024 LEARNING OUTCOMES At the end of the discussion, 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. 5.Categorize laboratories according to their biosafety level.  “PROTECT PEOPLE AGAINST BAD BUG” Containment principles, technologies, and practices implemented to prevent unintentional exposure to pathogens and toxins, or their unintentional release WHO Laboratory Safety Manual “PROTECT BAD BUG AGAINST BAD PEOPLE” Protection, control and accountability for valuable biological materials within laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release.  In 1943, US Pres. Franklin Roosevelt ordered the US BIOLOGICAL WEAPONS PROGRAM and was active during the COLD WAR. But this program was terminated by US PRES. Richard Nixon in 1969. IRA L. BALDWIN became the 1st scientific director of CAMP DETRICK (FORT DETRICK) Tasked with establishing the biological weapons program for defensive purposes to enable US to respond if attacked by such weapons. After World War II, Camp Detrick was designated a permanent installation for biological research and development. Tasked with establishing the biological weapons program for defensive purposes to enable US to respond if attacked by such weapons. He developed specific technical solutions such as CLASS III SAFETY CABINETS AND LAMINAR FLOW HOODS formed in 1984 promote biosafety as a scientific discipline and serve the growing needs of biosafety professionals. a pharmaceutical company in Pennsylvania developed a ventilated cabinet to prevent infection from Mycobacterium tuberculosis WHO aggressively pursed the eradication of the smallpox virus. Serious concerns about biosafety practices worldwide were raised. Consolidation of the remaining virus stocks into two locations: CENTER FOR DISEASE CONTROL AND PREVENTION (CDC) in US STATE RESEARCH CENTER OF VIROLOGY AND BIOTECHNOLOGY VECTOR (SRCVB VECTOR) in RUSSIA CDC published the CLASSIFICATION OF ETIOLOGICAL AGENTS ON THE BASIS OF HAZARD, that introduced the concept of establishing ascending levels of containment associated with risks in handling groups of infectious microorganisms.  The NATIONAL INSTITUES OF HEALTH (NIH) of the US published the NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES This explained in detail the microbiological practices, equipment, and facility necessarily corresponding to four ascending levels of physical containment. Laid the foundation for the introduction of a code of biosafety practice. marked the development of the practice of laboratory biosafety. Established the model of biosafety containment levels with certain agents. ensure that the proper equipment and facility controls are in place based on the specified biosafety levels of the laboratory  Director of INDUSTRIAL HEALTH and SAFETY at the US ARMY BIOLOGICAL RESEARCH LABORATORIES in 1944 Described the use of Considered as one of the pioneers of mechanical pipettors to biosafety. prevent laboratory-acquired infections in 1907 and 1908. In 1966, together with Wedum, analyzed multiple epidemiological studies of laboratory-based outbreaks. US Govt enacted the SELECT AGENT REGULATIONS to monitor the transfer of a select list of biological agents from one facility to another. Terrorist attacks and anthrax attacks (AMERITHRAX) occurred Revision of SELECT AGENT REGULATIONS in 2012 sought to address the creation of two tiers of select agents. Select agents are biological agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal or plant products. Variola major (smallpox) Foot-and-mouth disease virus  Biological agents and toxins act - Singapore Act on Prevention of infectious diseases in 2005 - South Korea Infectious Disease Variola major (smallpox) Control Law - Japan Foot-and-mouth disease virus In February 2008, the Comite Europeen de Normalisation (CEN) or European Committee for Standardization (CEN) published the CEN Workshop Agreement 15793 which focuses on laboratory biorisk management. This offers a mechanism where stakeholders can develop consensus standards and requirements in open process. The CWA 15793 was developed among experts from 24 different countries including, Argentina, Australia, Belgium, Canada, China, Denmark, US, UK, etc. was later on updated in 2011.  In 1983, the WHO published the 3rd edition of Laboratory Biosafety Manual to address concerns on biosafety guidance for research and health laboratories, issues on risk assessment and guidance to commission and certify laboratories. It includes Biosafety Levels 1-4, biological safety cabinets, good microbiological practices and how to disinfect and sterilize equipment. In terms of biosecurity, it covers the packaging required by international transport regulations. The Cartagena Protocol on Biosafety (CPB) Made effective in 2003 which applies to the 168 member-countries provides an international regulatory framework to ensure an adequate level of protection in the field of safe transfer, handling, and use of living modified organisms (LMO) resulting from modern biotechnology. March 17, 2006 the office of the President promulgated E.O 514 establishing NATIONAL BIOSAFETY FRAMEWORK (NBF) which prescribes the guidelines for its implementation, strengthening the National Committee on Biosafety of the Philippines. It is a combination of policy, legal, administrative, and technical instruments developed to attain the objective of Cartagena Protocol on Biosafety which the Philippines signed on May 24, 2000. The new NATIONAL COMMITTEE ON BIOSAFETY OF THE PHILIPPINES (NCBP) Established under E.O. 430 series of 1990 was formed on the advocacy efforts of scientists. The mandate of NCBP focuses on the organizational structure for biosafety. Department of Agriculture (DA) Also issued Administrative order No. 8 to set in place policies on the importation and release of plants and plant products derived from modern biotechnology. Department of Health (DOH), together with NCBP Formulated guidelines in the assessment of the impacts on health posed by modern biotechnology and its applications. A regional professional society founded in 1984. Promotes biosafety as a scientific discipline and provides guidance to its members in NORTH AMERICA. Founded in 2005 that acts as professional society for biosafety professionals in the Asia-Pacific region. Members are from SINGAPORE, BRUNEI, CHINA, INDONESIA, MALAYSIA, THAILAND, PHILIPPINES and MYANMAR. A nonprofit organization founded in June 1996. Focuses on encouraging and communicating among its members information and issues, as well as emerging legislation and standards. Long term goal is to assist the DA and DOH in their efforts to create a national policy and implement plan for laboratory biosafety and biosecurity.  A non-government and nonprofit association. It has launched numerous activities in cooperation and collaboration with other associations, on a national and international scale. “Assess, Mitigate, Monitor”  In 1996, Charles Baldwin, an environmental health engineer working for Dow Chemical Company containment systems products, created the biohazard symbol used in labeling biological materials carrying significant health risks. A systematic process of gathering information and evaluating the likelihood and consequences of exposure to or release workplace hazard/s and determining the appropriate risk control measures to reduce the risk to and acceptable risk. A combination of the LIKELIHOOD of an incident and the severity of the HARM (CONSEQUENCE) if that incident were to occur. An object or situation that has the potential to cause adverse effects when an organism, system, (sub)population is exposed to it. A systematic process of gathering information and evaluating the likelihood and consequences of exposure to or release workplace hazard/s and determining the appropriate risk control measures to reduce the risk to and acceptable risk. Includes the following: Virulence and pathogenicity Infectious dose Environmental stability Route/s of exposure Communicability Quantity concentration Availability of vaccine or treatment Gene product effects Origin of agent No or low individual and Moderate individual risk and community risk Low community risk High individual risk and High individual and Low community risk community risk  A microorganism that is unlikely to cause human disease or animal disease. A pathogen that can cause human or animal disease 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 preventative measures are available and the risk of spread of infection is limited. A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available. A pathogen that usually causes serious human or 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.  last line of defense and least effective method of control against a hazard and does NOT take the place of engineering or administrative controls means to put on and use PPE properly to achieve the intended protection and minimize the risk of exposure means removing PPE in a way that avoids self- contamination Gloves– protect hands and allow efficient removal of organisms from hands Gowns and Aprons– protect skin and clothing Face masks– protect mucous membranes of mouth and nose Respirators- prevent inhalation of infectious material Goggles – protect eyes Face shields – mucous membranes of face, mouth, nose and eyes  They are designated in ASCENDING ORDER, by degree of protection provided to the are used to identify the protective measures needed in a laboratory setting personnel, the environment and to protect workers, the environment, and the community the public. Designations are based on a composite of the design features, construction, containment facilities, equipment, practices and operational procedures required for working with agents from the various risk groups. Laboratories under BSL-1 are used to study infectious agents or toxins not known to consistently cause disease in healthy adults. Most appropriate among undergraduate and secondary educational training and teaching laboratories. They follow basic safety procedures (Standard Microbiological Practices) and require no special equipment or design features. Standard engineering controls in BSL-1 laboratories include easily cleaned surfaces that are able to withstand the basic chemicals used in the laboratory. BSL-2 laboratories are used to study moderate- risk infectious agents or toxins that pose a risk if accidentally swallowed, or exposed to the skin. (Blood, body fluids, tissues or primary cell lines) BSL-2 labs must also have access to equipment that can decontaminate laboratory waste, including an incinerator, an autoclave, and/or another method, depending on the biological risk assessment. applicable to clinical, diagnostic, teaching, research, or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease that may be transmitted through the air and through inhalation exposure. Researchers perform all experiments in biosafety cabinets that use carefully controlled air flow or sealed enclosures to prevent infection. Laboratories are designed to be easily decontaminated. These laboratories must use controlled, or “directional,” air flow to ensure that air flows from non-laboratory areas (such as the hallway) into laboratory areas as an additional safety measure.  Used for dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease that is frequently fatal, for which there are no vaccines or treatments, or a related agent with unknown risk of transmission. The laboratories incorporate all BSL 3 features and occupy safe, isolated zones within a larger building or may be housed in a separate, dedicated building Access to BSL-4 laboratories is carefully controlled and requires significant training. all work with infectious agents or toxins is done in a Class III Biosafety Cabinet​ with very carefully designed procedures to contain any potential contamination. In addition, the laboratory space is designed to also prevent contamination of other spaces. Laboratory personnel are required to wear full-body, air-supplied suits, which are the most sophisticated type of personal protective equipment​. All personnel shower before exiting the laboratory and go through a series of procedures designed to fully decontaminate them before leaving. BSCs, isolators and local exhaust ventilators are enclosed, ventilated working spaces that can be used in laboratories as primary containment devices. The most commonly used primary containment devices. Three different classes of BSC exist. It protects the operator, the laboratory environment and/or the work materials from exposure to infectious aerosols and splashes that may be generated when manipulating materials containing biological agents.  open-fronted enclosures that draw an inward airflow across the work surface through the front opening. The air passes upwards through a high efficiency particulate air (HEPA) filter before being exhausted. They provide personnel and environmental protection, but do not offer product protection for materials located in the work area. open-fronted enclosures, similar to Class I BSC, in which air enters the cabinet through the front opening to provide operator protection. The inward air bypasses the work area by being pulled through the front grill and underneath the workspace. Provides PRODUCT PROTECTION. TYPES: IIA ○is self-contained ○70% of the air is recirculated into the work area IIB ○exhaust is discharged outside the building ○used when the ff. are involved radioisotopes toxic chemicals carcinogens a closed, sealed, negative-pressure enclosure to which HEPA-filtered air is supplied. The enclosure is sealed to ensure safe gaseous decontamination. Operators access the working area using integrated gloves or gauntlets. Class III BSCs are normally f itted with a pass box (often independently ventilated) or dunk tank to facilitate the movement of potentially contaminated work materials in and out of the cabinet. Provides the highest level of safety to the lab worker. The goal of specimen transport is to maintain the specimen as near to its original state as possible--with minimal deterioration--and to prevent risks to the specimen handler.​ An infectious substance which is transported in a form that, when exposure occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. considered a dangerous good, yet deemed somewhat less dangerous than Category A. infectious substance which does not meet the criteria for inclusion in Category A. those collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissues and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment, and prevention. contains the specimen; placed in a test tube, it is screw-capped and is sealed with a waterproof tape​. Keep the vials in upright position. screw-capped, waterproof, and unbreakable​. s. Plastic pouches, if used, should be heat-sealed or tightly closed by applying rubber bands. There should be enough absorbent material (paper napkins/old newspaper) packed around the vials to absorb all fluid in case of breakage or leakage.  If a plastic pouch was used as a secondary container, it can now be placed inside a separate plastic container and adhesive tape should be applied around the lid of the container. A Thermocol box or vaccine carrier containing ice/gel packs could be used as the outer container.