Principles of Medical Technology 1 PDF Midterms 2024-2025

PRINCIPLES OF MEDICAL TECHNOLOGY 1 2024-2025 1ST SEMESTER- MIDTERMS In South Korea, the Act on Prevention of Infectious...

PRINCIPLES OF MEDICAL TECHNOLOGY 1 2024-2025 1ST SEMESTER- MIDTERMS In South Korea, the Act on Prevention of Infectious Diseases in 2005 was amended to require institutions that work with listed “ highly dangerous pathogens” to implement laboratory biosafety and biosecurity requirements. Brief History of Laboratory Biosafety In Canada, Canadian Containment Level (CL) 3 and CL4 facilities that work with risk group 3 or 4 are required to undergo certification. Rooted in the US biological weapons program which In 2008, the Danish Parliament passed a law that began in 1943 as ordered by then US President gives Minister of Health and Prevention to regulate Franklin Roosevelt and was active during the Cold biological agents War. In 1943, Ira L. Baldwin became the first scientific director of Camp Detrick (Fort Detrick) and was LOCAL AND INTERNATIONAL GUIDELINES ON tasked with establishing the biological weapons LABORATORY BIOSAFETY AND BIOSECURITY program for defensive purposes. Eventually terminated by US President Richard Nixon February 2008, the Comité européen de in 1969. Normalisation (CEN) published the CEN Workshop After Second World War, Camp Detrick was Agreement 15793. designated a permanent installation for biological In 1983, WHO published its 3rd edition of the research and development Laboratory Biosafety Manual. Newell A. Johnson designed modifications for In 2003, the Cartagena Protocol on Biosafety (CBP) biosafety at Camp Detrick ( Class III safety cabinets made effective which applies t 186 member countries and laminar flow hoods) National Committee on Biosafety of the Philippines In 1984, formation of the American Biological Safety (NCBP) established under E.O 430s.1990 was formed. Association(ABSA) On March 17, 2006, the Office of the President Arnold Wedum described the use of mechanical promulgated E.O 514 establishing the National pipettors to prevent laboratory acquired infections in Biosafety Framework (NBF) 1907 and 1908. Currently DOH, requires clinical laboratories to In 1909, a pharmaceutical company in Pennsylvania ensure policy guidelines on laboratory biosafety and developed a ventilated cabinet to precent infection biosecurity ( DOH A.O 27-2007) from Mycobacterium tuberculosis. At the height of increasing mortality and morbidity due to smallpox in 1967, WHO aggressively pursued Different Organizations in the Field of Biosafety the eradication of the virus. In 1974, the CDC published the Classification of 1. American Biological Safety Association (ABSA) a Etiological Agents on the Basis of Hazard that regional professional society for biosafety and introduced the concept of establishing ascending biosecurity founded in 1984. It promotes biosafety as levels of containment associated with risks. a scientific discipline and provides guidance to its In 1996, the US government enacted the Select Agent members on the regulatory regime present in North Regulations America. 2012, the revision of the Select Agent Regulations. 2. Asia-Pacific Biosafety Association (A-PBA) a group Singapore’s Biological Agents and Toxins Act is founded in 2005 that acts as a professional society similar un scope with the US regulations but with for biosafety professionals in the Asia-Pacific region. more severe penalties for noncompliance. Its members are from Singapore, Brunei, China, made by PRINCESS THARA CRUZ 🌷 Indonesia, Malaysia, Thailand, the Philippines, and Fundamental Concepts of Laboratory Biosafety and Myanmar. Active members of the International Biosecurity Biosafety Working Group are required to directly contribute to the development of the best biosafety Laboratory Biosafety are containment principles, practices.  technologies, and practices implemented to prevent unintentional exposure to pathogens and toxins, or 3. European Biological Safety Association (EBSA) a their unintentional release. non-profit organization founded in June 1996, that “PROTECTING PEOPLE FROM DANGEROUS aims to provide a forum for discussions and debates PATHOGENS” on issues of concern and to represent those working in the field of biosafety. EBSA focuses on encouraging Biosecurity are protection, control and and communicating among its members information accountability for valuable biological materials within and issues on biosafety and biosecurity as well as laboratories, in order to prevent their unauthorized emerging legislation and standards. access, loss, theft, misuse, diversion or intentional release 3. Philippine Biosafety and Biosecurity Association (PhBBA) created by a multidisciplinary team with “PROTECTING PATHOGENS FROM DANGEROUS members coming from the health and education PEOPLE” sectors as well as individuals from the executive, legislative, and judicial branches of the government. Also included are members of the steering committee and technical working groups of the National Laboratory Biosafety and Biosecurity Action Plan Task Force established as per DPO No. 2006-2500 dated September 15, 2006. A long term goal of the association is to assist the DA and DOH in their efforts to create a national policy and implement plan for laboratory biosafety and biosecurity. 4. Biological Risk Association Philippines (BRAP) a non-government and non-profit association that works to serve the emergent concerns of biological risk management in various professional fields such Risk Group 1 (low individual and community risk) as in the health, agriculture, and technology sectors throughout the country. It has launched numerous Unlikely to cause harm or disease on healthy activities in cooperation and collaboration with other individuals associations, on a national and international scale in the promotion of biosafety, biosecurity, and biorisk management as scientific disciplines. BRAP goes by includes microorganisms that are unlikely to cause the tagline, "assess, mitigate, monitor." human or animal disease. These microorganisms bring about low individual and community risk. Currently, member countries of ABSA, A-PBA, and EBSA have founded organizations in their respective nations which share the same goals and objectives in addressing issues and concerns related to biosafety and biosecurity. Risk Group 2 (moderate individual, low community high individual and community risk. risk) Can cause disease but moderate or less serious Classification of risk groups may vary from one hazard country to another depending on: Pathogenicity of the organism Preventive measures and medications available Mode of transmission, host range, immunity, vectors and environment Local availability of preventive measures - includes microorganisms that are unlikely to be a Local availability of effective treatment significant risk to laboratory workers and the community, livestock, or the environment. Laboratory exposure may cause infection, however, CATEGORIES OF LABORATORY BIOSAFETY ACCORDING effective treatment and preventive measures are TO LEVELS available while the risk of spread is limited. This risk group bring about moderate individual risk and BIOSAFETY 1 limited community risk. Well classified organisms Not cause infection to healthy person Risk Group 3 (high individual, low community risk) PPEs, Proper waste disposal, wash area, LIMITED ACCESS Can cause serious disease but not ordinarily Biosafety cabinet is not yet required spread BIOLOGICAL AGENTS: Bacillus subtilis Preventive measures and medications available Mycobacterium gordonae Naegleria gruberi E.coli includes microorganisms that are known to cause serious diseases to humans or animals and may present a significant risk to laboratory workers. It Biosafety Level 1 (BSL-1) could present a limited to moderate risk if these microorganisms spread in the community or the environment, but there are usually effective is suitable for work involving viable microorganisms preventive measures or treatment available. They that are defined and with well-characterized bring about high individual risk, and limited to strains known not to cause disease in humans. moderate community risk. Examples of microorganisms being handled in this level are Bacillus subtilis, Naegleria gruberi, infectious canine hepatitis virus, and exempt organisms under the NIH Guidelines. This level is the Risk Group 4 (high individual and community risk) most appropriate among undergraduate and secondary educational training and teaching laboratories that require basic laboratory safety NO MEDICATIONS, causes serious disease and easy practices, safety equipment, and facility design mode of transmission that requires basic level of containment. includes microorganisms that are known to BIOSAFETY 2 produce life-threater and may be readily transmissible from one individual to another while Well classified organisms, Pose MODERATE health effective treatment and preventive measures are hazard not usually available. In effect, they bring about Trained technologist, immunizations, BSC II cabinet, autoclave  COMMON AGENTS of INFECTIOUS diseases LETHAL BIOLOGICAL AGENTS: Highly trained technologists, SHOWER room and Human Immunodeficiency Virus NON-RECIRCULATING ventilation system, BSC III, Hepatitis B Virus Positive pressure suit, LAB IS ISOLATED FROM THE Bacillus anthracis INSTITUTION Yersinia pestis BIOLOGICAL AGENTS: Salmonella spp. Marburg and Congo Crimean Toxoplasma spp. Hemorrhagic Fever Viruses Arbovirus Arenavirus Biosafety Level 2 (BSL-2) Filovirus Small Pox virus is basically designed for laboratories that deal with indigenous moderate-risk agents present in the community. It observes practices, equipment, and Biosafety Level 4 (BSL-4) facility design that are applicable to clinical, diagnostic, and teaching laboratories is required for work with dangerous and exotic consequently observing good microbiological agents that pose high individual risks of techniques. life-threatening diseases that may be transmitted via the aerosol route, for which there are no available vaccines or treatment BIOSAFETY 3 Exotic or indigenous organisms AEROSOL transmission POTENTIALLY lethal BSC II or higher plus an ANTE room/changing room BIOLOGICAL AGENTS: Mycobacterium tuberculosis Systemic Fungi (molds) Francisella tularensis Brucella spp. St. Louis Encephalitis virus Coxiella burnetii Biosafety Level 3 (BSL-3) puts emphasis on primary and secondary barriers BIORISK MANAGEMENT (BRM) is a system or process in the protection of the personnel, the community, to control safety and security risks associated with the and the environment from infectious aerosol handling or storage and disposal of biological agents exposure. Work with indigenous or exotic agents and toxins in laboratories and facilities. with a potential for respiratory transmission, and that may cause serious and potentially lethal 3 primary components: Assessment, Mitigation and infection are being conducted here Performance (AMP) BIOSAFETY 4 Dangerous, exotic or newly classified organism AEROSOL or unknown MOT  Mitigation Procedure: Hierarchy of Controls Key Components of Biorisk Management Elimination- total decision not to work with a specific biological agent or not doing the intended Risk Assessment- Initial step in implementing a work biorisk management process Substitution- replacement of procedures or - Process of identifying the hazards and evaluating biological agent with similar entity the risks associated with biological agents and toxins, Engineering Controls- physical changes in work taking into account the adequacy of any existing stations, equipment or relevant work environment controls, and deciding whether or not the risks are Administrative Control- policies or standards and acceptable guidelines to control risks Personal Protective Equipment- devices worn by workers to protect them Hazard is an object that can cause harm Performance Evaluation Threat is a person who has an INTENT or ABILITY to Last pillar of biorisk management cause harm to other people, animal, or the institution Systematic process intended to achieve organizational objective and goals Risk can be based on either a hazard and or a Performance Management- reevaluation of the threat overall mitigation strategy RISK VS HAZARD LIKELIHOOD or CONSEQUENCE of a RISK harmful event/agent What are the chances that you will acquire the infection? BIOLOGICAL AGENT- Any microbiological entity, How severe will be the infection once cellular or non-cellular, naturally occurring or acquired? engineered, capable of replication or transferring HAZARD ANY OBJECT with a potential to cause genetic material that may be able to provoke harm infection, allergy, toxicity. A person with an intention to cause - Bacteria, viruses, fungi viroids, endo and harm is a THREAT ectoparasites BiOLOGICAL MATERIAL- Any material comprised of Risk Assessment containing or that may contain biological agents Steps in performing risk assessment: and/or harmful products such as toxins and Define the situation allergens. Define the risks BIOHAZARD- Any potential source of harm caused by Characterize the risks biological materials. Determine if risks are acceptable or not BIOSAFETY- principles, technologies and practices to prevent unintentional exposure to pathogens and Mitigation Procedure toxins or unintentional release. Second fundamental component of the biorisk BIOSECURITY- Policies, principles, technologies for management model protection and control of and accountability for Actions and control measures that are put into biological material. place to reduce or eliminate the risks associated with - Prevent intentional or accidental biological agents and toxins unauthorized access to and lost, theft misuse, There are five major areas of control or measures diversion or even weaponization of such that can be employed in mitigating risk: Elimination, commodities. Substitution, Engineering Controls, Administrative BIORISK- Risk associated with biological materials controls, Personal Protective Equipments (PPEs) AMP (ASSESSMENT, MITIGATION, PERFORMANCE)- is a microbiology, immunology and serology, hematology, simple but powerful model for managing biorisks. parasitology, clinical microscopy, toxicology, BIORISK ASSESSMENT- identifying the hazards and therapeutic drug monitoring, and endocrinology, evaluating the risks associated with biological agents among others. It is concerned with the diagnosis and and toxins, taking into account the adequacy of any treatment of diseases performed through laboratory existing controls. testing of blood and other body fluids. BIORISK MITIGATION- Actions and control measures that are put into place to reduce or eliminate risk 2. Anatomic Pathology is a clinical laboratory that associated with biological agents and toxins. focuses on the areas of histopathology, BIORISK PERFORMANCE- Improving biorisk immunohistopathology, cytology, autopsy, and management by recording, measuring and forensic pathology among others. It is concerned with evaluating organizational actions the diagnosis of diseases through microscopic examination of tissues and organs. KEY RESOURCES FOR BRM According to Institutional Characteristics 1. To address handling, management and containment of biological agents and 1. An institution-based is a clinical laboratory that materials that pose threat to human health operates within the premises or part of an institution as well as prevention of their unauthorized such as a hospital, school, medical clinic, medical access, loss and theft. facility for overseas workers and seafarers, birthing 2. Other health laboratories are encouraged to home, psychiatric facility, drug rehabilitation center, use this manual as guidance if applicable and others. Hospital-based clinical laboratories are 3. This is also not intended for laboratories that the most common example of institution. based perform animal and plant related products. laboratories. MANAGEMENT SYSTEM- is a set of interrelated or 2. A free-standing clinical laboratory is not part of an interacting elements of an organization to establish established institution. The most common example is policies, objectives. a free-standing out-patient clinical laboratory. According to Ownership 1. Government-owned clinical laboratories are owned, wholly or partially, by national or local THE CLINICAL LABORATORY government units. Examples are the clinical and anatomical laboratories of DOH. run government hospitals like the San Lazaro Hospital, Jose R. Reyes An essential component of health institutions Memorial Medical Center, University of the Main Task: to provide accurate and reliable Philippines-Philippine General Hospital and local information to medical doctors for the diagnosis, government-run hospital-based clinical laboratories prognosis, treatment and management of diseases of the Ospital ng Maynila Medical Center, Sta. Ana It is a place where specimens collected from an Hospital, and Bulacan Medical Center. individuals are processed, analyzed, preserved and properly disposed. 2. Privately-owned clinical laboratories are owned, established, and operated by an individual, CLASSIFICATION OF CLINICAL LABORATORY corporation, institution, association, or organization. Examples are St. Luke's Medical Center, Makati According to Function Medical Center, and MCU-FDTMF Hospital. 1. Clinical Pathology is a clinical laboratory that focuses on the areas of clinical chemistry, immunohematology and blood banking, medical  According to Service Capability 4. National Reference Laboratory(NRL) -government hospital designated by the DOHto provide certain 1. Clinical laboratories under the primary category special diagnostic functions and services for certain are licensed to perform basic, routine laboratory diseases testing, namely, routine urinalysis, routine stool examination, routine hematology or complete blood LAWS ON THE OPERATION, MAINTENANCE AND count that includes hemoglobin, hematocrit, WBC REGISTRATION OF CLINICAL LABORATORIES IN THE and RBC count, WBC differential count and qualitative PHILIPPINES platelet count, blood typing, and Gram staining (if hospital-based). Equipment requirements are, but not Republic Act 4688: “An Act Regulating the Operation limited to, microscopes, centrifuge, hematocrit and Maintenance of Clinical Laboratories and centrifuge. Space requirement is at least 10 square Requiring the Registration of the Same with the meters. Department of Health, Providing Penalty for the Violation Thereof, and for Other Purposes” - services rendered include routine hematology, urinalysis, fecalysis, and Gram Administrative Order No. 59 s. 2001: “Rules and staining. Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the 2. secondary category (Hospital and Philippines.” non-hospital-based) are licensed to perform laboratory tests being done by the primary category SECTION 1: clinical laboratories along with routine clinical Any person, firm or corporation, operating and chemistry tests like blood glucose concentration, maintaining a clinical laboratory in which body fluids, blood urea nitrogen, blood uric acid, blood creatinine, tissues, secretions, excretions and radioactivity from cholesterol determination, qualitative platelet count, beings or animals are analyzed for the determination and if hospital-based, Gram stain, KOH mount, and of the presence of pathologic organisms, processes crossmatching. A minimum requirement of 20 square and/or conditions in the persons or animals from meters is needed for the floor area of this type of which they were obtained, shall register and secure a laboratory. Personnel requirement depends on the license annually at the office of the Secretary of workload. Minimum equipment requirements are Health: provided, that government hospital microscopes, centrifuge, Hematocrit centrifuge, laboratories doing routine or minimum laboratory semi-automated chemistry analyzers, autoclave, examinations shall be exempt from the provisions of incubator, and oven. this section if their services are extensions of government regional or central laboratories. - services rendered include those of the Primary Category plus routine chemistry, SECTION 2 blood typing, and crossmatching. It shall be unlawful for any person to be professionally in-charge of a registered clinical 3. tertiary category (Hospital and laboratory unless he is a licensed physician duly non-hospital-based) are licensed to perform all the qualified in laboratory medicine and authorized by laboratory tests performed in the secondary category the Secretary of Health, such authorization to be laboratory plus (1) immunology and serology (eg, renewed annually. SI-Ag for dengue, rapid plasma reagin, Treponema No license shall be granted or renewed by the pallidum particle agglutination tests); Secretary of Health for the operation and maintenance of a clinical laboratory unless such - services rendered include those of the laboratory is under the administration, direction Primary and Secondary Categories plus and supervision of an authorized physician, as donor selection and blood collection, special provided for in the preceding paragraph. chemistry, and special hematology procedures. SECTION 3  The Secretary of Health, through the Bureau of Research and Laboratories shall be charged with the responsibility of strictly enforcing the provisions of this Act and shall be authorized to issue such rules and Schedule of application forRenewal of License regulations as may be necessary to carry out its provisions NCR- January to March 1,2,3 & CAR- February to April SECTION 4 4,5 & 6- March to May- Any person, firm or corporation who violates any 7,8 & 9- April to June- provisions of this Act or the rules and regulations 10, 11, 12, CARAGA & ARMM- May to July issued there under by the Secretary of Health shall be punished with imprisonment for not less than one month but not more than one year, or by a fine of not less than one thousand pesos nor more than five thousand pesos, or both such fine and imprisonment, at the discretion of the court. SECTION 5 If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof. SECTION 6 The sum of fifty thousand pesos, or so much thereof as may be necessary, is hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effect the provisions of this Act. SECTION 7 All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed. SECTION 8 This Act shall take effect upon its approval. Approved: June 18, 1966 3. Application for renewal of license A duly notarized application form “Application for Renewal of License to Establish, Operate and Maintain a Clinical Laboratory” shall be filed by the owner or his duly authorized representative at the respective CHD. a. Renewal of License: Application for renewal of license shall be filed within 90 days before the expiry date of the license described as follows: Region