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Pmls Midterms Reviewer

1. This document provides a review of medical terminologies, abbreviations, and information about medical technology education. 2. It defines key terms used in medical terminology by identifying their roots, prefixes, suffixes, and rules for pluralization. Common abbreviations used in healthcare are also listed. 3. Guidelines for the Bachelor of Science in Medical Technology/Medical Laboratory Science program from the Commission on Higher Education are summarized, including curriculum requirements and the roles of the Technical Committee for Medical Technology Education.

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0% found this document useful (0 votes)
275 views10 pages

Pmls Midterms Reviewer

1. This document provides a review of medical terminologies, abbreviations, and information about medical technology education. 2. It defines key terms used in medical terminology by identifying their roots, prefixes, suffixes, and rules for pluralization. Common abbreviations used in healthcare are also listed. 3. Guidelines for the Bachelor of Science in Medical Technology/Medical Laboratory Science program from the Commission on Higher Education are summarized, including curriculum requirements and the roles of the Technical Committee for Medical Technology Education.

Uploaded by

Cute ni Leynes
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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PMLS MIDTERMS REVIEWER cortex cortices

MEDICAL TERMINOLOGIES AND ABBREVIATIONS 4. Words ending in -is: transform to es


- Derived from Greek and Latin words SINGULAR PLURAL
1. Root word – main part of the medical term that metastasis metastases
denotes the meaning of the word diagnosis diagnoses
anastomosis anastomoses
Examples:
prothesis protheses
colo - colon nephron - kidney
phlebo - vein hemat - blood 5. Words ending in -ix: transform to ices
cardio - heart aero - air SINGULAR PLURAL
arterio- artery myo - muscles cervix cervices
arthro – joint cyto - cells appendix appendices
hepa/hepato - liver pyo - pus
thrombo - clot cranio - skull 6. Words ending in -ma: transform to ta
pyro - fever osteo - bone SINGULAR PLURAL
2.
Prefix – found at the beginning of the word and shows sarcoma sarcomata
how the meaning is assigned to the word fibroma fibromata
Examples: stroma stromata
a/an – without, absence poly – many 7. Words ending in -on: transform to a
hyper – increase, above pre – before SINGULAR PLURAL
iso – same pseudo – false ganglion ganglia
micro – small mono – one spermatozoon spermatozoa
macro – large nano – billionth
intra – inside, within hypo – decreased 8. Words ending in -us: transform to i
anaero – without oxygen homo – same, like SINGULAR PLURAL
cryo – cold neo - new thrombus thrombi
dys – abnormal, bad phago – eat, ingest bronchus bronchi
3.
Suffix – found at the terminal portion of the term and alveolus alveoli
also denotes the meaning of the root word embolus emboli
Examples: calculus calculi
emia – blood ostomy – opening bacillus bacilli
uria – urine poiesis – formation 9. Words ending in -um: transform to a
itis – inflammation pathy – disease
megaly – enlargement meter – measure
SINGULAR PLURAL
blast - young ectomy - removal bacterium bacteria
cidal – killing of penia – deficiency diverticulum diverticula
oma – tumor, growth tome – cutting atrium atria
lysis – destruction, dissolve phil/philic – attraction ovum ova
Combining Vowel – added between root word and suffix 10. Words ending in -y: transform to ies
if: suffix starts with a consonant (usually o) SINGULAR PLURAL
PLURAL FORM OF MEDICAL TERMS therapy therapies
biopsy biopsies
1. Words ending in -a: transform to ae
11. Words ending in -x: transform to ges
SINGULAR PLURAL
SINGULAR PLURAL
axilla axillae
larynx larynges
pleura pleurae
meninx meninges
conjuctiva conjuctivae
phlanax phalanges
vertebra vertabrae
scapula scapulae ABBREVIATIONS
petechiae petechiae - shortened forms of words
2. Words ending in -ax: transform to ces - used for efficient communication
SINGULAR PLURAL - must not be used if unsure of its meaning
thorax thoraces DOH Department of Health
pneumothorax pneumothraces CHED Commission on Higher Education
VDRL Venereal Disease Research Laboratory
3. Words ending in -ex: transform to ices AIDS Acquired Immunodeficiency Syndrome
SINGULAR PLURAL AIDs Autoimmune disorders/diseases
AMI Acute Myocardial Infarction
vortex vortices
BUN Blood Urea Nitrogen
apex apices
BUA Blood Uric Acid TECHNICAL COMMITTEE FOR MEDICAL TECHNOLOGY
2PPBS 2 hours Postprandial Blood sugar EDUCATION (TCMTE) (UNDER CHED)
AFS Acid Fast Stain - composed of leading academicians and practioners
PCQACL Philippine Council for Quality Assurance in
responsible for assisting the Commission in setting the
Clinical Laboratories
FBS Fasting Blood Sugar standard among institutions offering BSMT/BSMLS
IV Intravenous BACHELOR OF SCIENCE IN MEDICAL TECHNOLOGY/MEDICAL
HIV Human Immunodeficiency Virus LABORATORY SCIENCE (BSMT/BSMLS)
U International Unit - allied health program
ICU Intensive Care Unit - four-year course (first three years: professional courses and
K Potassium
Na Sodium general education; fourth year: internship training)
NPO Nothing Per Orem COMMISSION ON HIGHER EDUCATION (CHED)
BAP Blood Agar Plate MEMORANDUM ORDER NO. 13, SERIES OF 2017
STAT Shortest Turn Around Time Policies, standards, and guidelines for the Bachelor of Science
CBC Complete Blood Count in Medical Technology/Medical Laboratory Science program
UA Urine Analysis
FA Fecal Analysis - serves as a guide for institutions offering the program that
UTI Urinary Tract Infection complies with the K-12 curriculum
URTI Upper Respiratory Tract Infection
AUB Abnormal Uterine Bleeding one (1) unit of lecture: one (1) hour of class
ETBD Etiology to be determined one (1) unit of laboratory: three (3) hours of class
CKD Chronic Kidney Disease
MEDICAL TECHNOLOGY / CLINICAL LABORATORY * Clinical Bacteriology should be completed before taking
EDUCATION Immunology and Serology

DEFINITION OF CURRICULUM GENERAL EDUCATION COURSES (GE)


- From the latin word “currere” which means “to run” 1.) Understanding the Self 6.) The Life and Works of
Rizal
a.) accd. to Glossary of Educational Reforms – curriculum
2.) Readings in Philippines 7.) Science, Technology, and
refers to skills and knowledge that students are expected to History Society
learn (includes: leaning standards or objectives and 3.) The Contemporary World 8.) Art Appreciation
assessments that evaluates students) 4.) Mathematics in the 9.) Ethics
b.) means and materials for achieving identified outcomes Modern World
c.) aacd. to John Dewey – “continuous reconstruction, moving 5.) Purposive
from the child’s present experience out into that represented Communication
by the organized bodies of truth that we call studies… the PROFESSIONAL COURSES
various studies… are themselves experience-they are that of 1.) Principles of Medical Laboratory Science 1: Introduction to
the race” Medical Laboratory Science, Laboratory Safety, and Waste
d.) accd. to Indiana Department of Education – planned Management (pmls 1)
interaction of student with instructional content and processes - deals with the basic concepts and principles of MT/MLS
for evaluation the attainment of educational objectives - its curriculum, practice, clinical laboratories, continuing
✓ systematic and organized professional education, biosafety practices, and waste
✓ explicitly states outcomes management
✓ consists of planned process of measurement, assessments, 2.) Principles of Medical Laboratory Science 2: Clinical
and evaluations Laboratory Assistance and Phlebotomy (pmls 2)
✓ designed for students - concepts and principles of the different assays performed in
the clinical laboratory
MEDICAL TECHNOLOGY CURRICULUM
- phlebotomy that deals with the concepts, principles, and
Commission on Higher Education (CHED) standard procedures in blood collection, transport, and
- established on May 18, 1994 processing
- covers both public and private higher education - pre-analytic, analytic, and post-analytic variables that affect
- tasked to organize and assign members of the technical panel reliability of test results
of programs under CHED 3.) Community and Public Health for MT/MLS
- study of foundations of community health
- includes: human ecology, demography, and epidemiology
-promotion of community, public, and environmental health - pathophysiology, epidemiology, life cycle, prevention and
and the immersion and interaction of students with people in control, and identification of ova and/or adult worms
the community
4.) Cytogenics tests performed by students:
- study of heredity and inheritance ✓ Microscopic identification ✓ different methods of
- includes: genetic phenomena, sex determination, genetic of diagnostic features of preparing smear for
different groups of parasites microscopic examination
defects rooted in inheritance
pathogenic to man (e.g., (e.g., direct fecal smear,
- abnormalities and genetic disorders involving the nametodes, trematodes, kato-katz, among others)
chromosomes and nucleic acids (DNA and RNA) cestodes, protozoa,
- analysis of nucleic acids and their application to medical plasmodium, among others)
science
9.) Immunohematology and Blood bank
5.) Human Histology
- concepts of inheritance, characterization, and laboratory
- study of fundamentals of cells, tissues, and organs
identification of red cells antigens and their corresponding
- microscopic structures, characteristics, differences, and
antibodies
functions
tests performed by students:
- microscopic identification and differentiation of cells that
make up the systems of the body ✓ ABO and Rh typing ✓ compatibility testing
6.) Histopathologic Techniques with Cytology ✓ coombs test ✓ transfusion reaction
work-up
- concepts and principles of disease processes, etiology, and
✓ blood donation process ✓ preparation of RBC
the development of anatomic, microscopic changes
suspension
10.) Mycology and Virology
tests performed by students:
- study of fungi and viruses as agents of diseases
✓ tissue processing ✓ mounting of stained tissue
- epidemiology, laboratory identification and characterization,
for microscopic examination
and prevention and control
✓ cutting of processed tissue ✓ performing biosafety and
waste management 11.) Laboratory Management
✓ staining - planning, organizing, staffing, directing and controlling
- solving problems, quality assurance and quality control,
7.) Clinical Bacteriology preparation of policy, and procedure manuals
- study of physiology and morphology of bacteria and their role 12.) Medical Technology Laws and Bioethics
in infection and immunity - laws and administrative orders, and other approved legal
- collection of specimen and the identification of bacteria, documents related to the practice
antimicrobial susceptibility testing and development of - bioethics is the study of ethics applied to health and delivery
resistance to antimicrobial substances 13.) Hematology 1
- concepts of blood as a tissue
tests performed by students:
✓ preparation of culture ✓ collection of specimen tests performed by students:
media ✓ complete blood count ✓ fragility test
✓ preparation of bacterial ✓ staining of smear (cbc)
smear ✓ hematocrit blood test ✓ erythrocyte indices
✓ inoculation of specimen on ✓ characterization of colonies ✓ platelet count ✓ reticulocyte count
culture media of bacteria growing in culture
✓ preparation of blood ✓ instrumentation
media
smear and staining
✓ performing different ✓ biosafety and waste ✓ red cell morphology ✓ osmotic fragility test
biochemical tests for management
✓ erythrocyte ✓ quality assurance and
identification of bacteria
sedimentation rate (esr) quality control
✓ quality assurance and ✓antimicrobial susceptibility
✓ biosafety and waste
quality control testing
management
8.) Clinicial Parasitology 14.) Hematology 2
- study of animal parasites in humans and their medical - concepts and principles of hemostasis, and abnormalities
significance involving red blood cells (rbc), white blood cells (wbc), and
platelets
tests performed by students: - molecular mechanisms of DNA replication, repair,
✓ identification of ✓ coagulation factor test transcription, translation, protein synthesis, and gene
abnormal RBC and WBC (e.g., activated partial regulation
thromboplastin time [aptt],
RESEARCH COURSES
prothrombin time [pt],
bleeding time [bt], clotting Research 1: Introduction to Laboratory Science Research
time [ct], clot retraction time - basic concepts and principles of research
[crt]) - ethical research
✓ special staining ✓ instrumentation Research 2: Research Paper Writing and Presentation
techniques
- methodology of the research from research 1
15.) Clinical Microscopy CLINICAL INTERNSHIP TRAINING
- study of urine and other body fluids (except blood) - taken during the fourth (4th) year
Interns are required 32 hours of duty per week and a total of
tests performed by students:
1664 hours in one year
✓ routine urinalysis ✓ pregnancy tests
HOURS PROGRAM
✓ special chemical ✓ chemical examination of
300 hrs Clinical chemistry
examination of urine stool specimens
200 hrs Clinical microscopy and parasitology
✓ examination of other body 250 hrs Microbiology
fluids 300 hrs Hematology
200 hrs Blood banking
16.) Clinical Chemistry 1
100 hrs Histopathologic techniques and cytology
- concepts and principles of physiologically active soluble
220 hrs Immunology and serology
substances and waste materials present in body fluids (blood) 40 hrs Laboratory management
- instrumentation and automation, quality assurance, and 54 hrs Phlebotomy
quality control 1664 hrs TOTAL
tests performed by students:
✓ instrumentation ✓ renal function tests (blood LICENSURE EXAMINATION
urea nitrogen [bun], blood PROFESSIONAL REGULATION COMMISSION (PRC)
uric acid [bua], creatinine) - government agency under the Office of the President
✓ quality assurance and ✓ protein testing (total - tasked to administer licensure examination to different
quality control proteins, albumin, globulin) professionals
✓ glucose determination ✓ biosafety and waste PROFESSIONAL REGULATORY BOARD (PRB) FOR MEDICAL
management TECHNOLOGY/MEDICAL LABORATORY SCIENCE
✓ lipid testing (triglyceride, - under PRC
lipoproteins) - tasked to prepare and administer the written licensure
examinations for graduates qualified to take the examination
17.) Clinical Chemistry 2
composed of:
- continuation of Clinical Chemistry 1
- includes: endocrine glands and hormones and their
✓ one (1) chairperson (duly licensed pathologist)
formation, laboratory analyses, and clinical correlation ✓ two (2) registered medical technologist
* PRB members are required to be holders of PRC licenses
tests performed by students: Examination is given twice a year: March and August
✓ bilirubin tests ✓ hormone testing REPUBLIC ACT 5527, “THE MEDICAL TECHNOLOGY ACT OF
✓ clinical enzymology ✓ drug testing 1969”
(transferases, 1.) MT Laws and Bioethics, and Laboratory Management –
dehydrogenase. hydrolases) not included in RA 5527 but are now included in the board
✓ electrolyte testing exam)
18.) Seminars 1 and 2 20% Clinical chemistry
20% Microbiology and Parasitology
- taken during the fourth (4th) year
20% Hematology
- deals with current laboratory analyses used in the practice 20% Blood Banking and Immunology and Serology
19.) Molecular Biology and Diagnostics 10% Clinical Microscopy
- deals with nucleic acid and protein molecule interaction 10% Histopathologic Techniques
within the cell
4.) Actively participate in self-directed life-long learning
activities to be updated with the current trends in the
profession
2.) Requirements to pass: - MT/MLS involves a state of constant learning and re-learning
✓ GWA of 75% to effectively carry out the practice
✓ no rating below 50% in any major courses 5.) Actively participate in research and community-oriented
✓ pass atleast 60% of the courses computed according to their activities
relative weights Research – systematic and organized study of materials to
3.) Examinee should be 21 years old and above to receive a PRC come up with new conclusions or to establish facts
card as a licensed medical technologist. If under 21 yrs old the 6.) Be endowed with leadership skills
PRC card would be held until their 21st birthday Leader – sets the direction of a group, someone who has
4.) If the examinee failed three (3) times they are required to excellent communication skills, motivates, and inspires others,
enroll in a refresher course before retaking the examination and is not afraid to develop others who may end up better than
5.) If the examinee failed the examination but has a GWA of him or her
70% - 74% they may apply for certification as a medical 7.) Demonstrate collaboration, teamwork, integrity, and
laboratory technician respect when working in a multicultural environment

PROGRAM GOALS AND LEARNING OUTCOMES ASSESSMENT


HIGHER EDUCATIONAL INSTITUTIONS (HEIS) - inherent in a learning activity
- must have a written document stating the program goals, - planned, systematic, and organized way of testing,
vision and mission, objective, and learning outcomes based on measuring, collecting, and obtaining necessary information to
the institutions’ philosophy gain feedback on a student’s progress
1.) Demonstrate knowledge and technical skills needed to FUNCTIONS OF ASSESSMENT TECHNIQUES:
correctly perform laboratory testing and ensure reliability of 1.) provides feedback on the progress of students toward the
test results achievement of learning outcomes
Knowledge – comprised of Technical skills – 2.) it identifies the flaws in the psychomotor skills an
facts, information, and psychomotor domain of deficiencies in the theoretical knowledge and conceptual
concepts acquired through learning skills of the student
experience and education - a graduate should be able 3.) it serves as a diagnostic tool to determine the capabilities
(important to understand to perform the tests in each of a student so that the teacher can prepare additional
the task to be accomplished) section of the laboratory exercises and activities to address his or her needs during the
2.) Be endowed with the professional attitude and values
assessment
enabling them to work with their colleagues and other
4.) it serves as a motivation to further improve a student’s
members of the health care delivery system
skill set in a particular learning strategy which serves as a
- attitude deals with the affective domain
basis for retaining or changing a strategy
- how feelings, emotions, tone of voice, attitude, and
5.) it provides information on students’ response to a
disposition of a BSMT/BSMLS is managed when faced with
particular learning strategy which serves as a basis for
favorable or unfavorable situations in the workplace
retaining or changing a strategy
3.) Demonstrate critical thinking and problem solving skills
6.) it provides information to the teacher if there is need to
when confronted with situations, problems, and conflicts in the
improve teaching and learning strategies
practice of their profession
7.) it determines the demonstrable changes in the attitude
Critical thinking – Problem solving – Decision making –
and behavior of students
ability to detailed analysis ability to gather
objectively and of the problem at and synthesize 8.) it determines whether learning has taken place
systematically hand by focusing facts, TYPES OF ASSESSMENT
analyze, without on present facts information, and
1.) Formative Assessment
bias, facts and and information opinions about
information to before making a the problem at - defined by W. James Popham (2008), “is a planned process
come up with decision hand in which assessment-elicited evidence of students’ status is
reasonable used by teachers to adjust their ongoing instructional
decisions procedures or by students to adjust their current learning
tactics”
- done during and/or within the instructional process of the 4 Member of the academe (faculty, clinical instructor,
course clinical coordinator, dean/ department chair, academic
coordinator)
e.g., quizzes, short-answer questions, reflection papers, etc
5 Perfusionist
2.) Summative Assessment 6 Molecular scientist
- done at the end of instruction, grading period 7 Diagnostic product specialist
- to learn how well the student learned 8 Public health practitioner
e.g., prelim, mid-terms, finals, exams, research papers, term 9 Health care leader
papers, final projects A graduate may also practice in the following fields:
1 Molecular Biology
3.) Diagnostic Assessment 2 Public Health and Epidemiology
- given prior to instruction 3 Veterinary Laboratory Science
- to know what the students already know and do not know 4 Food and Industrial Microbiology
about the topic 5 Veterinary Science
6 Forensic Science
ASSESSMENT TOOLS 7 Nuclear Medicine/Science
* If the learning outcomes measures higher-order thinking 8 Health Facility Administration and Management
9 Quality Management
skills (HOTS) matching type is not appropriate
* If the learning outcome measures lower-order thinking skills BASIC CONCEPTS ON LABORATORY BIOSAFETY AND
(LOTS) memorization is need and essay questions are not BIOSECURITY
appropriate BRIEF HISTORY OF LABORATORY BIOSAFETY
1.) teacher-made written tests
1907 – 1908
- very popular and widely used
Arnold Wedum – described mechanical pipettors to
e.g., quizzes, long exams, term exams, and comprehensive
prevent laboratory acquired infections (LAI)
exams
1909
2.) reflection papers
Melford Pharmaceuticals – (pharmaceutical company
- collection of outputs that show their progress at the end of
from Pennsylvania) developed a ventilated cabinet to
the course program
prevent infection from mycobacterium tuberculosis
3.) portfolios
1943
- usually given in the laboratory component of a course
US President Franklin Roosevelt – ordered the US
4.) performance tasks
biological weapons program that establishes biological
- measures the attainment of psychomotor skills necessary
weapons for defensive purposes (active during the cold
for the correct performance of practical procedures in the
war)
laboratory
Ira L. Baldwin – became the first scientific director of Camp
e.g., practical exams, return demonstrations (retdem), move
Detrick (eventually became Fort Detrick)
system, and objective structured clinical examination (OSCE)
*after the second world war (WWII)
5.) oral examinations and presentation
- Camp Detrick was designated a permanent installation for
- gauges competency through oral communication skills
research and development
- requires a lot of preparation
Newell A. Johnson – designed modifications for biosafety
6.) rubrics
at the camp (e.g., class iii safety cabinets and laminar flow
- assessment tool that evaluates the work of a student based
hood)
on a particular criteria
1944
- better version of a checklist rating scale
Arnold Wedum – (director of Industrial Health and Safety
- very versatile
at the US Army Biological Research Laboratories) was
can be used for: oral presentations, case analyses, essays,
recognized as one of the pioneers of biosafety
portfolios, performance tasks, and self and peer evaluations
1966
JOB OPPORTUNITIES FOR THE GRADUATE OF THE Arnold Wedum, Morton Reitman (microbiologist), and
PROGRAM colleagues at Fort Detrick – analyzed multiple
A BSMT/BSMLS graduate can practice as a/an: epidemiological studies of laboratory-based outbreaks
1 Medical technologist/clinical laboratory scientist in a 1967
hospital-based or non-hospital-based clinical laboratory * due to the increase of mortality and morbidity rates against
2 Histotechnologist in an anatomical laboratory smallpox
3 Researcher/research scientist
World Health Organization (WHO) – in response to the - required institutions that work with “highly dangerous
concern about biosafety worldwide, WHO consolidated the pathogens” to implement laboratory biosafety and
remain virus stocks into two locations: biosecurity requirements
- Center for Disease Control and Prevention (CDC) in the JAPAN: Infectious Diseases Control Law (under Japan’s
United States Ministry of Health, Labor, and Welfare)
- State Research Center for Virology and Biotechnology - established four schedules of select agents that are
VECTOR (SRCVB VECTOR) in Russia subject to different reporting and handling requirements
1969 for possession, transport, and other activities
US President Richard Nixon – terminated US Biological CANADA: Canadian Containment level (CL) 3 and 4 facilities
Weapons Program - work with risk groups 3 and 4 that are required to undergo
1974 certification
Center for Disease Control and Prevention (CDC) – DANISH PARLIAMENT: authority for the Minister of Health
published “Classification of Etiological Agents on the Basis and Prevention to regulate possession, manufacture, use,
of Hazard” that introduced the concept of ascending levels storage, etc.
of containment associated with risks in handling groups of * biosecurity has become a purely administrative activity that
infectious diseases is based on a government-developed checklist
1976 (two years after) LOCAL AND INTERNATIONAL GUIDELINES ON
National Institute of Health (NIH) – published “NIH
LABORATORY BIOSAFETY AND BIOSECURITY
Guidelines for Research Involving Recombinant DNA
COMITÉ EUROPÉEN DE NORMALISATION (CEN)
Molecules” that explained the four ascending levels of
- published CEN Workshop Agreement 15793 (CWA 15793)
physical containment which laid the foundation for the
introduction of a code of biosafety practice – focuses on laboratory biorisk management that offers
mechanisms where the stakeholders can develop
1983
consensus standards and requirements in an open process
WHO’s first (1st) edition of Laboratory Biosafety Manual
- conformity is voluntary
1984
CDC and NIH’s jointly published first (1st) edition of - developed from 24 different countries
- updated in 2011
Biosafety in Microbiological and Biomedical Laboratories
- expired in 2014
* the two publications marked the development of practice of
rd
3 edition of LABORATORY BIOSAFETY MANUAL
laboratory biosafety
- includes the different levels pf containment laboratories
1984
(biosafety levels 1 – 4), different types of biological safety
American Biological Safety Association (ABSA) – held
cabinets, good microbiological techniques, and how to
annual meetings that became the ABSA annual conference
disinfect and sterilize equipment
BRIEF HISTORY OF BIOSECURITY - no mechanisms to ensure that the guidelines are being
1996 adhered to
Select Agent Regulations – monitors the transfer of a CARTAGENA PROTOCOL ON BIOSAFETY (CPB)
select list of biological agents from one facility to another - made effective in 2003
* after terrorist attacks and the anthrax attacks of 2001 called - signed on May 24, 2000
Amerithrax - applies to the 168 member-countries provides an
2001 international regulatory framework
The US government revised the Select Agent Regulations - ensure “an adequate level of protection in the field of safe
then required specific safety measures for any facility in the transfer, handling, and use of living modified organisms
United States (LMOs) resulting from modern biotechnology”
SINGAPORE: Biological Agents and Toxins Act (Republic of - the legislation provides a framework to assess the risk of
Singapore 2005) LMOs to negatively affect biodiversity
- similar with the US but has more severe punishments for NATIONAL COMMITTEE ON BIOSAFETY OF THE
noncompliance PHILIPPINES (NCBP)
SOUTH KOREA: Act on Prevention of Infectious Diseases in - established under E.O. 430 series of 1990
2005 - formed on the advocacy efforts of scientists
- focuses on the organizational structure for biosafety
NATIONAL BIOSAFETY FRAMEWORK (NBF) FUNDAMENTAL CONCEPTS OF LABORATORY
- expansion of NCBP
BIOSAFETY AND BIOSECURITY
- created on March 17, 2006
Accd. to WHO’s Laboratory Biosafety Manual (LBM):
- promogulated E.O. 514
DEPARTMENT OF AGRICULTURE (DA) BIOSAFETY BIOSECURITY
- the containment - the protection, control,
- issued Administrative Order No. 8
principles, technologies, and and accountability for
- policies on the importation and release of plants and plant practices that are valuable biological materials
products derived from modern biotechnology implemented to prevent within laboratories, in order
DEPARTMENT OF HEALTH (DOH) AND NATIONAL unintentional exposure to to prevent their
COMMITTEE ON BIOSAFETY OF THE PHILIPPINES (NCBP) pathogens and toxins, and unauthorized access, loss,
- formulated guidelines for the impacts on health posed by their accidental release theft, misuse, diversion, or
modern biotechnology and its applications intentional release
by simple definition:
- evaluates and monitors processed food derived from or
BIOSAFETY BIOSECURITY
containing GMO
- protects people from - protects germs from
DOH ADMINISTRATIVE ORDER NO. 2007-0027 germs people
- requires laboratories to follow policy guidelines on - focuses on laboratory - maintenance of secure
laboratory biosafety and biosecurity procedures and practices procedures and practices in
DIFFERENT ORGANIZATIONS IN THE FIELD OF necessary to prevent handling biological materials
exposure to and acquisition and sensitive information
BIOSAFETY of infections
1.) American Biological Safety Association (ABSA) Charles Baldwin (1969) – an environmental health engineer
- founded in 1984 that created the biohazard symbol used to label biological
- regional professional society for biosafety and biosecurity materials carrying significant health risks
- promotes biosafety as a scientific discipline and provides CLASSIFICATIONS OF MICROORGANISMS
guidance to its members on the regulatory regime present in
ACCORDING TO RISK GROUPS
North America
2.) Asia-Pacific Biosafety Association (A-PBA) - based on the agent’s pathogenicity, mode of transmission,
- founded in 2005 host range, and the availability of preventative measures and
- professional society for biosafety professionals in the Asia- effective treatments
Pacific region - by the World Health Organization (WHO)
3.) European Biological Safety Association (EBSA) Risk Group 1 - microorganisms that are unlikely to cause
diseases
- founded in June 1996
- low individual and community risk
- non-profit organization Risk Group 2 - microorganisms that are unlikely to be a
- aims to provide a forum for discussions and debates on issues significant risk to laboratory workers and
- encourages and communicates among its members the community
information and issues, as well as emerging legislation and - laboratory exposure may cause infection
standards - effective treatment and preventive
4.) Philippine Biosafety and Biosecurity Association (PhBBA) measures are available
- risk of spread is limited
- includes the committee of National Laboratory Biosafety and
- moderate individual risk and limited
Biosecurity Action Plan Task Force (established as per DPO No. community risk
2006-2500 dated September 15, 2006) Risk Group 3 - microorganisms that are known to cause
- created by a multidisciplinary team with members coming serious diseases
from the health and education sectors - significant risk to laboratory workers
- assists the DA and DOH in their efforts to create a national - limited to moderate risk if the infection
policy and implement plan for laboratory biosafety and spreads
- there are usually preventive measures
biosecurity
and treatment available
5.) Biological Risk Association Philippines (BRAP) - high individual risk and limited to
- non-government and non-profit association moderate community risk
- serves the emergent concerns of biological risk management Risk Group 4 - microorganisms that are known to
- goes by the tagline “assess, mitigate, monitor” produce life-threatening diseases
- significant risk to laboratory workers
- readily transmissible from one individual - typically a separate building or completely
to another isolated with specialized ventilation and waste
- effective treatment and preventive management systems
measures are not usually available - staff must have specific and thorough training in
- high individual and community risk handling
- must be by a laboratory supervisor
CATEGORIES OF LABORATORY BIOSAFETY
e.g., Marburg or the crimean-congo hemorrhagic
ACCORDING TO LEVELS fever
- based on a composite of the design features, construction, BIORISK MANAGEMENT
containment facilities, equipment, practices, and operational Biorisk – risks associated to Biorisk Management –
procedures required for working with agents from the various biological toxins or integration of biosafety and
risk groups infectious agents biosecurity to manage risks
- by the Center for Disease Control and Prevention (CDC) when working with
biological toxins and
BSL-1 - handles viable microorganisms which are known
infectious agents
to not cause diseases in humans
Accd. to CEN Workshop Agreement (CWA 15793: 2011):
- appropriate among undergraduates and
secondary educational training and teaching “a system or process to control safety and security risks
laboratories associated with the handling or storage and disposal of
- requires basic laboratory safety practices, safety biological agents and toxins in laboratories and facilities”
equipment, and facility design - encompasses the identification, understanding, and
- basic level of containment management aspects of a system in interrelated processes
e.g., bacillus subtilis, naegleria gruberri, and
- identified risks can either be mitigated, avoided, limited,
infectious canine hepatitis virus
transferred to an outside entity, or accepted
BSL-2 - deals indigenous moderate-risk agents
- work is done with human body substances AMP MODEL
(blood, fluids, tissues, or primary cell lines) where
there is uncertain presence of infectious agents
- hand washing sinks and waste decontamination
facilities must be available
- infectious aerosols must be operated in biosafety
cabinets
e.g., hepatitis B virus, HIV, salmellae, and
toxoplasma species
BSL-3 - emphasizes primary and secondary barriers
- deals with indigenous or exotic agents with a
potential for respiratory transmission (infectious
aerosol exposure)
- required to be performed in a biosafety cabinet
with gas-tight aerosol generation chamber
secondary barriers: controlled access to the
laboratory and ventilation
- personnel must be supervised by competent
scientists
e.g., mycobacterium tuberculosis, st. louis
encephalitis virus, and coxiella
BSL-4 - deals with dangerous and exotic agents that has
high individual risks of life-threatening diseases - a biorisk management system that fails if one of the
that may transmit through an aerosol route (have components, or legs, is overlooked or not addressed
no available vaccines or treatment) RISK ASSESSMENT
- specific practice, safety equipment, and
appropriate facility design and contractions are - initial step in implementing a biorisk management process
required - identification of hazards and characterization of risks that are
- it is required for personnel class iii biosafety possibly present in the laboratory
cabinet or in a full-body, air-supplied positive- Hazard – refers to anything in the environment that has the
pressure personnel suit potential to cause harm
Risk – possibility that something bad or unpleasant will
happen
e.g., a sharp needle is a hazard but if no one is using it the *effectivity of mitigating risks relies on the combination of all
needle has no risk the different measures and the proper utilization of each
STEPS FOR RISK ASSESSMENT: PERFORMANCE EVALUATION
1.) Define the situation – identify the hazards and risks of the
- last pillar of the bioris kmanagement model
biological agents to be handled
Performance evaluation - systematic process intended to
2.) Define the risks – review of how individuals inside and
achieve organizational objectives and goals
outside the laboratory may be exposed to the hazards
Performance management – reevaluation of the overall
3.) Characterize the risks – comparison of the likelihood and
mitigation strategy
the consequences of infection (either qualitatively or
quantitatively)
4.) Determine if risks are acceptable or not – evaluating the
biorisk arising from a biohazard that takes into account the
adequacy of any existing controls, and deciding whether or not
the biorisk is acceptable
MITIGATION PROCEDURES
- second fundamental component of the biorisk management
model
- actions and control measures that are put into place to
reduce or eliminate the risks associated with biological agents
and toxins

- only through this final process that findings could be decided


upon, given appropriate action, to be able to provide and
establish a clear manifestation of implementing the
fundamental concept of biosafety and biosecurity in the
laboratory.

Elimination – most difficult but most effective


control measure
- total decision not to work with a
specific biological agent or even not
doing the intended work
Substitution - replacement of the procedures or
biological agent with a similar entity in
order to reduce the risks
Engineering - physical changes in work stations,
controls equipment, production facilities, or any
other relevant aspect of the work
environment that can reduce or prevent
exposure to hazards
Administrative - policies, standards, and guidelines used
controls to control risks
-proficiency and competency training for
laboratory staff
Personal - devices worn by workers to protect
Protective them against chemicals, toxins, and
Equipment pathogenic hazards in the laboratory.
(PPE)

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