LEC-06-Basic-Concepts PDF

BATCH 2028 TRANS A.Y. 2024-2025 No. 011-092024 College of Medical Laboratory Science (CMLS) MT-MLS 101A: Principles of Medical Laboratory Science I LEC/LAB: Basic Concepts on Labo...

BATCH 2028 TRANS A.Y. 2024-2025 No. 011-092024 College of Medical Laboratory Science (CMLS) MT-MLS 101A: Principles of Medical Laboratory Science I LEC/LAB: Basic Concepts on Laboratory Biosafety and Biosecurity Transcribed by: Nigella B. Rivera NOTE: This trans is STRICTLY PROHIBITED from unauthorized distribution and photocopying for other purposes solely than the recipient’s personal use. A unique tracking number has been incorporated for all the batches of transes distributed by the CMLS-SC Academics Committee. Thus, should we have been notified that this trans has undergone unwarranted distribution, even beyond the 4 course of this PRELIM – FIRST SEMESTER of the A.Y. 2024-2025, the CMLS-SC Academics Committee has the right to terminate 02 this project for the said respective batch. -2 OUTLINE Newell Johnson developed Class II safety cabinets and laminar flow 23 I. Brief History of Laboratory Biosafety hoods for enhanced research II. Brief History of Laboratory Biosecurity protection. 20 III. Local and International Guidelines on Laboratory 1944 Arnold Wendum introduced comprehenssive Biosafety and Biosecurity containment, which became foundational to infection IV. Different Organizations in the Field of Biosecurity control in labs. Y. A. American Biological Safety Association (ABSA) 1966 Wendum and Morton conducted a key analysis A. B. Asia-Pacific Biosafety Association (A-PBA) linking unsafe practices to laboratory-acquired C. European Biological Safety Association (EBSA) infections, prompting a global awareness of D. Philippine Biosafety and Biosecurity Association biosafety. (PhPBA) E 1967 The World Health Assembly published the WHO TE E. Biological Risk Association Philippines (BRAP) Biosafety Guidlines, formalizing international V. Chain of Infection biosafety practices for the first time. VI. Fundamental concepts of Laboratory Biosafety and 1969 President Richard Nixon ended the US Biological IT Biosecurity Weapons Program, marking a shift toward biosafety A. Similarites of Laboratory Biosafety and Biosecurity and ethical biological research. MM VII. Classifications of Microorganisms According to Risk 1974 THe CDC and NIH published more formal biosafety Groups practices, formalizing the framework for the evolving VIII. Categories of Biosafety According to Levels field. CO IX. Key Points 1976 The NIH issued its first guidelines for research involving recombinant DNA, addressing the biosafety BRIEF HISTORY OF LABORATORY BIOSAFETY needs in gene manipulation. 1984 The CDC and NIH jointly published the Biosafety in S Microbiological and Biomedical Laboratories IC DATE EVENT (BMBL), setting the gold standard for modern 1907-1908 Arnold Wendum developed mechanical pipettors to laboratory biosafety. EM prevent laboratory-acquired infections, marking an early step in biosafety innovation BRIEF HISTORY OF LABORATORY BIOSECURITY 1909 A pharmaceutical company in Pennsylvania created AD the first ventilated cabinet to contain Mycobacterium Tuberculosis, setting the stage for airborne DATE EVENT pathogen containment. 1996 Select Agent Regulations (SAR) AC 1943 During World War II, the US Biological ○ Monitor the transfer of a select Weapons Program was established at list of biological agents from one Camp Detrick under President Franklin facility to another. Roosevelt 2001 AMERITHRAX Ira L. Baldwin was appointed ○ Revised SAR required specific scientific director security measures for any facility in CMLSSC Academics Committee A.Y. 2023-2024 Page 1 of 2  Basic Concepts on Laboratory Biosafety and Biosecurity MT-MLS 101A: Principles of Medical Laboratory Science I the US that used or stored more ○ Provides guidance to its members on the agents. regulatory regime present in North America. 2005 Singapore Asia-Pacific Biosafety Association (A-PBA) ○ Biological Agents and Toxins ○ Founded in 2005 Act ○ Regional professional society for Biosafety in South Korea the Asia-Pacific region 4 ○ Act on Prevention of Infectious Diseases ○ Contribute to the developement of the best 02 Japan Biosafety practices in the laboratory. ○ Infectious Diseases Control ○ Members are from: Singapore, Brunei, China, -2 Law Indonesia, Malaysia, Thailand, Philippines, 2008 Danish Parliament 23 and Myanmmar. ○ Passed a law that gives the European Biological Safety Association (EBSA) Minister of Health and Prevention 20 to Regulate the Possession, ○ Founded in June 1996 manufacture, use, storage, sale, ○ Non-profit organization purchase or dispossal of listed ○ Provide a forum for discussions and debates on Y. biological agents. issues of concerns. A. ○ Represent those working in the field of biosafety LOCAL & INTERNATIONAL GUIDELINES ON LABORATORY Philippine Biosafety and Biosecurity Association BIOSAFETY & BIOSECURITY E (PhBBA) ○ Created by a multidisciplinary team with TE March 17, 2006 members coming from: the health and education ○ Office of the President promulgated E.O. 514 sectors, and individuals from the executive, IT establishing the National Biosafety legislative, and judicial branches. Framework (NBF) MM ○ Steering committee and technical working ○ Which prescribes the guidelines for its groups of the National Laboratory Biosafety implementation, stregnthening the National and Biosecurity Action Plan Task Force - Committee on the Biosafety of the Philippines. CO established as per DPO No. 2006-2500 dated National Biosafety Framework (NBF) September 15, 2006 ○ Is a combination of policy, legal, administrative, ○ Assists Department of Agricultrure (DA) and and technical instruments developed to attain DOH in their efforsts to create a national policy S the objective of the Cartagena Protocol on and impliment the plan for laboratory biosafety IC Biosafety which the Philippines signed on May and biosecurity 24, 2000. Biological Risk Association Philippines (BRAP) EM ○ Non-government and non-profit association DIFFERENT ORGANIZATIONS IN THE FIELD OF ○ Serve the emergent concerns of biological risk BIOSECURITY AD management in various professioanl fields: health, agriculture, and technology sectors. American Biological Safety Association (ABSA) ○ Promote Biosafety, Biosecurity,and Biorisk AC ○ Founded in 1984 management as scientific disciplines. ○ Professional society for biosafety and ○ Tagline: assess, mitigate, monitor biosecurity professionals. ○ Promotes biosafety as a scientific discipline CMLSSC Academics Committee A.Y. 2023-2024 Page 2 of 6  Basic Concepts on Laboratory Biosafety and Biosecurity MT-MLS 101A: Principles of Medical Laboratory Science I CHAIN OF INFECTION Systems Products, created the Biohazard symbol. How microorganisms are transmitted ○ Biohazard Symbol Requires a continous link between an infectious agent, a Represents an importantpart of reservoir, a portal of exit, a means of transmission, a biosafety and biosecurity. portal of entry, and a susceptible host. 4 Biological Hazards SIMILARITIES & DIFFERENCES OF LABORATORY 02 ○ Causative Agents: BIOSAFETY AND BIOSECURITY Bacteria -2 Parasites DIFFERENCES BIOSAFETY BIOSECURITY 23 Fungi Viruses Protects peoplke from Protects germs from germs people 20 Example: Common Cold ○ Virus - infectious agents → Laboratory procedures Maintenance of ○ Respiratory Tract - reservoir → and practices secure procedures Y. ○ Sneeze/Cough - portal of exit → Prevents exposure and and practices aquisition of infections Biological materials A. ○ Air - mode of transmission → ○ Inhaled by anothe person - portal of entry → and sensitive information. E ○ Person with weak immune system - susceptible host TE Breaking any link can help prevent the spread of infection Most effective way to break COI is to eliminate SIMILARITIES IT Infectious agent Assessment Evaluate risk to ensure safety Methodology Protocols used to maintain MM FUNDAMENTAL CONCEPTS OF LABORATORY BIOSAFETY safety and security & BIOSECURITY Personnel Trained and authorized peoplke Control and Access Managing who has access to CO Biosafety biological materials and ○ “The containment principles, technologies, and ensuring containment practices that are implemented to prevent Transfer Security transfer of biological S unintentional exposure to pathogens and toxins materials between localities to IC or their accidental release” - WHO Laboratory prevent unatuhorized access Biosafety Manual (2006) and release EM Biosecurity Training Educating personnel to ensure ○ “The protection, control, and accountability for compliance both safety and AD valuable biological materials within laboratories, security regulations in order to prevent their unauthorized access, Planning Prepare for potential incidents loss, theft, diversion, or intentional release.” - or risk, both intentional and AC WHO Laboratory Biosafety Manual (2006) unintentional misuse Charles L. Baldwin (1966) Management Overaching cordination of ○ An environmental health engineer working for biosafety and biosecurity in Dow Chemical Company Containement efforts to protect the public health CMLSSC Academics Committee A.Y. 2023-2024 Page 3 of 6  Basic Concepts on Laboratory Biosafety and Biosecurity MT-MLS 101A: Principles of Medical Laboratory Science I ○ Usually effective preventive measures and CLASSIFICATIONS OF MICROORGANISMS ACCORDING TO treatment are available RISK GROUP Example: Microbacterium Tuberculosis - can be killed ussing different antibiotics for 6 months of medication Basis of Risk Group Classification: ○ Agent’s pathogenicity RISK GROUP 4 4 Abilitiy of agent to cause disease 02 ○ Mode of Transmission High individual and community risk Causative agent to spread Life threatening disease – highly transmissible -2 Airborne ○ Treatment and preventive measures are not 23 droplet usually available ○ Host range Example: Ebola Virus - causative agent of hemorragic 20 Variety of host can be infected fever ○ Availability of preventive measures Vaccines CATEGORIES OF LABORATORY BIOSAFETY ACCORDING Y. Preventive protocols TO LEVELS A. ○ Availability of effective treament Treatment Basis of Biosafety Levels: Therapist ○ Composite of the design features E Overall design of the laboraotry TE RISK GROUP 1 ○ Construction Physical structure IT Low individual/community risk Windows Microorganisms are unlikely to cause human or animal Tight doors MM disease ○ Containment facilities Example: Bacillus Subtilis Special designed rooms/systems to prevent microorganisms from escaping CO RISK GROUP 2 ○ Equipment Proper protective equipment Moderate individual/limited community risk Biosafety cabinet S Microorganisms are unlikely to be a significant risk to Hepa filters IC laboratory workers, community, livestock, and ○ Practices environment Laboratory practices EM ○ May cause infection but treatment and How specimens are handled preventive measures are available and disposed ○ Risk of spread is limited AD ○ Operational procedures Example: Staphylococcus Aureus - can cause skin Standard operating procedures (SOP) irritations BSL - 4 - most life threatening agent AC BSL - 1 - most basic among the four RISK GROUP 3 BIOSAFETY LEVEL 1 High individual/limited to moderate community risk Known to cause serious disease to humans or animals Pose minimal risk CMLSSC Academics Committee A.Y. 2023-2024 Page 4 of 6  Basic Concepts on Laboratory Biosafety and Biosecurity MT-MLS 101A: Principles of Medical Laboratory Science I Viable microorganisms known not to cause disease in Laboratory biosafety and biosecurity are two important humans. concepts in laboratory practice. The integration of ○ non -pathogenic organisms principles into actual laboraotry practice especially in an Undergraduate and secondary educational training and academic institution provides protection from pathogenic microorganiosms by way of unintentional or intentional teaching laboratories release into the environment Example: Bacillus subtilis, Naegleria gruberi, 4 Microorganisms are classifies into 4 different risk groups: infectious canine hepatitis virus risk group 1,risk group2, risk group 3, and risk group 4. 02 Based on an agents pathogenicity, mode of BIOSAFETY LEVEL 2 transmission, host range, and the availability of -2 preventative measures and effective treatment Laboratories are classified according to biosafety levels 23 Indigenous moderate-risk agents namely: Biosafety level 1, Biosafety level 2, Biosafety Human blood, body fluids, tissues, or primary human cell level 3, and Biosafety level 4.each is designed to work 20 lines where there is uncertain presence of infectious withg organisms in each risk group agents. Example: Hepatitis B virus, Salmonella, HIV, Y. Toxoplasma A. BIOSAFETY LEVEL 3 E Emphasis on primary and secondary barriers for TE protection Indigenous and exotic agents with potential for IT respiratory transmission and may cause serious and potentially lethal infection MM Examples: Mycobacterium tuberculosis, Coxiella, St. Louis encephalitis virus CO BIOSAFETY LEVEL 4 Dangerous and exotic agents that pose high individual S risks of life threatening disease IC A separate building or completely isolated zone with specialized ventilation and waste management systems EM Example: Marburg virus, Crimean - Congo hemorrhagic fever AD KEY POINTS The formulation of biosafety guidelines and practices is a AC breakthrough in sciences. Knowing both the history of biosafety and biosecurity on a national and international scale aids in enriching current trends in biosafety and biosecurity practices. These are several organizations across continents which advocate biosafety and biosecurity CMLSSC Academics Committee A.Y. 2023-2024 Page 5 of 6  Basic Concepts on Laboratory Biosafety and Biosecurity MT-MLS 101A: Principles of Medical Laboratory Science I References: Benitez, P. Dumaoal, O.S., Estrella, F., Mortel, F. and Nava, M.R. (2019). Principles of Medical Laboratory Science 1. C&E Publishing Inc. 4 PPT Presentation Courtesy of Sir Roy Martin Cerrado 02 Principles of Medical Laboratory Science Professors: -2 Sir Roy Martin Cerrado 23 Maam Arianne Rose A. Lim 20 Transcribed by: Nigella B. Rivera Y. A. Counter Checked by: E TE IT MM CO S IC EM AD AC CMLSSC Academics Committee A.Y. 2023-2024 Page 6 of 6