Basic Concepts on Laboratory

Biosafety and Biosecurity

LABORATORY BIOSAFETY
✓ The containment principles, technologies and practices that
are implemented to prevent the unintentional exposure to pathogens
and toxins, or their accidental release.

LABORATORY BIOSECURITY
✓ The protection, control, and accountability for valuable
biological materials within laboratories, in order to prevent their
unauthorized access, loss, theft, misuse, diversion,
or intentional release.

❖ Laboratory Biosafety is limiting the agent/pathogen’s access to

people
❖ Laboratory Biosecurity is limiting people’s access to
the agent/pathogen.

HISTORY OF LABORATORY BIOSAFETY

✓ 1969 – The biological
weapons program was
terminated by US
President Richard Nixon
✓ After the Second World
War, Camp Detrick was
designated a
permanent installation for
biological research
and development.
1943 ✓ Newell A. Johnson
– designed modifications
✓ Ira L. Baldwin – first
for biosafety at
scientific director of Camp Camp Detrick
Detrick (Fort Detrick) ✓ 1984 – formation
✓ US President Franklin of American Biological
Roosevelt tasked Baldwin Safety Association
to establish US biological (ABSA)
weapons program for ✓ 1967 – began of
defensive purposes during the Intensified
the Cold War Eradication Program of
smallpox
 • Following the eradication of smallpox in 1980, scientists and
public health officials determined there was still a need to perform
research using the variola virus.

• The World Health Assembly agreed to reduce the number of

laboratories holding stocks of variola virus (United States,
England, Russia, and South Africa)

• By 1984, England and South Africa either destroyed the

stocks or transferred them to other approved labs. Therefore, only
two locations where variola virus is officially stored.

Center for Disease Control and Prevention (CDC)

The Centers for Disease Control and Prevention (CDC) is a federal agency
that conducts and supports health promotion, prevention, and preparedness
activities in the United States, with the goal of improving overall public health.
Established in 1946 and based in Atlanta, the CDC is managed by
the Department of Health and Human Services (HHS).
State Research Center of Virology and Biotechnology VECTOR
(SRCVB VECTOR)
The State Research Center of Virology and Biotechnology VECTOR,
also known as the Vector Institute, is a biological research center in
Koltsovo, Novosibirsk Oblast, Russia. It is roughly analogous to both
the Centers for Disease Control and Prevention and the US Army Chemical
and Biological Defense Command. It has research facilities and capabilities
for all levels of Biological Hazard, CDC Levels 1-4. It is one of two official
repositories for the now-eradicated smallpox virus, and is part of the system
of laboratories known as the Biopreparat.
Classification of Etiologic Agents on the Basis of Hazard
• Published by CDC, and introduced the concept of establishing
ascending levels of containment associated with risks in handling
groups of infectious microorganisms that present similar
characteristics

NIH Guidelines for Research Involving Recombinant DNA Molecules

• Explained in detail the microbiological practices, equipment, and
facility necessarily corresponding to four ascending levels of physical
containment

➢ Laboratory Biosafety Manual (1983)

➢ Biosafety in Microbiological and Biomedical Laboratories (1984)

• marked the development of the practice of laboratory biosafety

 • established the model of biosafety containment levels with certain
agents which increased the biosafety levels for biological agents that
pose risk to human health.

➢ Biosafety Officers
• ensures that the proper equipment and facility controls are in
place based on the specified biosafety level of the laboratory.

➢ Arnold Wedum – director of Industrial Health and Safety;

recognized as one of the pioneers of biosafety

➢ Morton Reitman – together with Wedum, analyzed

multiple epidemiological studies of laboratory-based outbreaks
1984
• Members of the Rajneeshee commune purchased a strain
of Salmonella from a medical supply company in Seattle,
Washington
• They contaminated ten local salad bars, sickening over 750
individuals
• Although not immediately recognized as an attack, this incident was
a clear indication of the potential impact on the misuse of biological
agents
2001 (Amerithrax)

• At least 5 envelopes containing Bacillus anthracis spores (etiologic

agent of anthrax) were mailed to US senators and media
organizations
• After 10 years of investigation, it was found out that the spores were
derived from a single spore-batch of Bacillus anthracis, isolated from
a cow in Texas and distributed to a number of research
laboratories, including United States Army Medical Research
Institute for Infectious Diseases (USAMRIID)

Other bacteria used for bioterrorism

• Yersinia pestis – through rats containing flea; causes bubonic
plague
• Vibrio cholerae – causes cholera through contaminated water or
food
• Francisella tularensis – causes tularemia through ticks
1996 – Select Agent Regulations
• to monitor the transfer of a select list of biological agents from
one facility to another
• Biological Agents and Toxins Act (Singapore)
• Act on Prevention of Infectious Diseases (South Korea)
• Infectious Disease Control Law (Japan)

DIFFERENT ORGANIZATIONS IN THE FIELD OF BIOSAFETY

• American Biological Safety Association (ABSA)
• Asia-Pacific Biosafety Association (A-PBA)
• European Biological Safety Association (EBSA)
• Philippine Biosafety and Biosecurity Association (PhBBA)
• Biological Risk Association Philippines (BRAP)

AMERICAN BIOLOGICAL SAFETY ASSOCIATION

• regional professional society for biosafety and biosecurity founded in
1984
• Promotes biosafety as a scientific discipline and
provides guidance to its members on the regulatory regime present
in North America
ASIA PACIFIC BIOSAFETY ASSOCIATION
• group founded in 2005 that acts as a professional society
for biosafety professionals in the Asia-Pacific region.
 • Active members of the International Biosafety Working Group
are required to directly contribute to the development of the
best biosafety practices
• Singapore, Brunei, China, Indonesia, Malaysia, Thailand, Myanmar,
and Philippines.
EUROPEAN BIOLOGOICAL SAFETY ASSOCIATION
• a non-profit organization founded in June 1996
• Aims to provide a forum for discussions and debates on issues
of concern and to represent those working in the field of biosafety.
• Focuses on encouraging and communicating among its
members information and issues on biosafety and biosecurity as
well as emerging legislation and standards

PHILIPPINE BIOSAFETY AND BIOSECURITY ASSOCIATION

• Created by a multi-disciplinary team with members coming from
the health and education sectors as well as individuals from
executive, legislative, and judicial branches of the government.
• Goal of this association is to assist the DA and DOH in their efforts
to create a national policy and implement plan for laboratory
biosafety and biosecurity
• National Laboratory Biosafety and Biosecurity Action Plan Task
Force – established September 15, 2006

BIOLOGICAL RISK ASSOCIATION PHILIPPINES

• Non-government and non-profit association that works to serve
the emergent concerns of biological risk management in
various professional fields such as in the health, agriculture, and
technology sectors throughout the country
• “Assess, mitigate, monitor”

FUNDAMENTAL CONCEPTS
• Charles Baldwin – an environmental health engineer working for the
Dow Chemical Company containment systems products
• Created the biohazard symbol used in labeling biological
materials carrying significant health risks.
CLASSIFICATION OF MICROORGANISMS
WHO recommends an agent risk group classification for laboratory use that
describes four general risk groups based on principal characteristics and
relative hazards posed by infectious toxins or agents
• Agent’s pathogenicity
• Mode of transmission
• Host range
• Availability of preventive measures and effective treatment

RISK GROUP 1
• No or low individual and community risk
• Includes microorganisms or material containing microorganisms that
are already present in the environment and are unlikely to cause
human, plant or animal disease, disrupt a region or an industry.
RISK GROUP 2
• Moderate individual risk, and low/ limited community risk
• Includes microorganisms, or material containing microorganisms that
can cause human, plant, or animal disease but is likely to be serious
hazard to laboratory workers, community, livestock or the
environment.
RISK GROUP 3
• High individual risk and limited to moderate community risk
 • Includes microorganisms or material containing microorganisms that
usually causes serious human, plant, or animal disease and may
present serious risk to laboratory workers.
• It could present risk if spreads in the community, in a region, to the
livestock industry or the environment but there are usually effective
preventive measures or treatment available.
RISK GROUP 4
• High individual and community risk
• Includes microorganisms or material containing microorganisms that
are known to produce life threatening diseases to humans or
animals.
• It represents a significant risk to laboratory workers and may be
readily transmissible from one individual to another; effective
treatment and preventive measures are not usually available.
CATEGORIES OF LABORATORY BIOSAFETY
CDC categorized laboratories based on:
• Design features and construction
• Containment facilities
• Equipment
• Practices
• Operational procedures
Laboratory Biosafety according to levels:
• Biosafety level 1
• Biosafety level 2
• Biosafety level 3
• Biosafety level 4

BIOSAFETY LEVEL 1(BSL-1)

• Suitable for work involving viable microorganisms that are known not
to cause disease in humans.
• It is most appropriate among undergraduate and secondary
educational training and teaching laboratories
BIOSAFETY LEVEL 2 (BSL-2)
• Basically designed for laboratories that deal with indigenous
moderate-risk agents present in the community.
• It observes practices, equipment, and facility design that are
applicable to clinical, diagnostic, and teaching laboratories
consequently observing good microbiological techniques.
• It is appropriate when work is done with human blood, body
fluids, tissues, or primary human cell lines where there is uncertain
presence of infectious agents.
 • All procedures where infectious aerosols or splashes may be created
are conducted in biosafety cabinets or other physical containment
equipment.
BIOSAFETY LEVEL 3 (BSL-3)
• Designed for laboratories that deal with indigenous or exotic
agents with a potential for respiratory transmission, and that may
cause serious and potentially lethal infection.
BIOSAFETY LEVEL 4 (BSL-4)
• Laboratory required when working with dangerous and exotic
agents that pose high individual risks of life-threatening diseases that
may be transmitted via the aerosol route, for which there are no
available vaccines or treatment.
• The laboratory worker’s complete isolation from aerosolized
infectious materials is accomplished primarily by working in a Class III
biosafety cabinet or in a full-body, air-supplied positive-pressure
personnel suit.

BIORISK MANAGEMENT
“A system or process to control safety and security risks associated
with the handling or storage and disposal of biological agents and
toxins in laboratories and facilities”
Bio risk is the risk associated to biological toxins or infectious agents.
INFECTIOUS AGENTS:
Bacteria, Fungi, Virus, and Parasites
NORMAL FLORA IS NOT A BIORISK
• Staphylococcus aureus - skin
• Lactobacillus - vagina
Sources of risk:
✓ Unintentional exposure to
unauthorized access
✓ No PPE ✓ Intentional unauthorized
✓ accidental release or loss release of biohazards
✓ Anthrax
✓ Theft
✓ Bioterrorism
✓ Misuse
✓ Diversion
 RISK ASSESSMENT
➢ Initial step in implementing a
biorisk management process.
➢ Includes identification of hazards
and characterization of risks that
are possibly present in the
laboratory

HARM
The adverse effect on the health of people, animals, or plants.
HAZARD
Anything in the environment that has the potential to cause harm
RISK
The possibility that something bad or unpleasant will happen
THREAT
Likelihood of the harm to occur, as an expression of intention to inflict evil,
injury, or damage

STEPS IN PERFORMING RISK ASSESSMENT

1. Define the situation
✓ Identify the hazards and risks of the biological agents to be
handled
✓ Identify the at-risk hosts – who could be exposed to the
hazard and risks; they could be inside and outside of the
laboratory.
✓ Identify locations, procedures, and equipment needed.
2. Define the risks
✓ It includes a review of how the at-risk hosts may be exposed to
the hazards
✓ It could either be through droplets, inhalation, ingestion, or
inoculation in case of a biological agent has been identified as
the hazard
3. Characterize the risks
✓ to characterize the overall biosafety risks, the risk
assessment team needs to compare the likelihood and the
consequences of infection
✓ Hazard assessment
 ✓ Host assessment
✓ Work activities and Laboratory Environment assessment
✓ Overall Risk characterization
4. Determine if risks are acceptable or not
✓ it takes into account the adequacy of any existing controls
and deciding whether or not the bio risk is acceptable.
5. Implement Risk Mitigation Procedures, as needed

MITIGATION PROCEDURES

Elimination

Substitution
Engineering controls
Administrative Controls
PPE

CONTROLS OF MITIGATION PROCEDURES

Personal Protective Equipment
➢ Devices worn by workers to protect them against chemicals, toxins,
and pathogenic hazards in the laboratory
➢ It is considered the least effective measure because it only protects
the person who is wearing it, and only when it is used correctly.
Administrative Controls
➢ Refers to the policies standards, and guidelines used to control risks
➢ Examples: Competency training for laboratory staff, displaying of
biohazard or warning signage, markings, and labels
Engineering Controls
➢ It includes physical changes in workstations, equipment, production
facilities, or any other relevant aspect of the work environment that
can reduce or prevent exposure to hazards.
➢ Examples: autoclave, biosafety cabinets, centrifuge with cover,
ventilation systems to ensure directional airflow.
 Substitution
➢ Replacement of the procedures or biological agent with a similar entity
in order to reduce the risk
Elimination
➢ Involves the total decision not to work with a specific biological agent
or even not doing the intended work.
Performance Evaluation
➢ The implementation of the entire bio risk management system,
including evaluation and ensuring that the system is working the way
it was designed.
➢ It ensures that the mitigation controls or measures are indeed
reducing or eliminating risks.
➢ We could also highlight bio risk strategies that are not working
effectively and measures that are ineffective or unnecessary

Identify the key

issues of concern

Evaluate and Refine Define OUTCOMES

Performance
indicators

Provide findings from Define Activities

performance
indicators

Collect Data and Report

Indicator results

PROFESSIONAL ORGANIZATIONS
These are assemblages of professionals within a particular specialization
or professional field that come together for the purpose of collaboration,
networking, and professional development or advancements
Assemblages = group of people
What is the purpose?
• To promote the particular professional field, they are part of
• To educate the public on issues relevant to the industry
• To represent the interests of the industry in various groups
• To provide opportunities for professional growth and continuing
education
• Interested individuals must pay membership fees and monthly or
yearly dues to avail or access the benefits and services that
professional organizations offer to their members.
• In the Philippines, membership to an Accredited Professional
Organization (APO) or Accredited Integrated Professional
Organization (AIPO) is a requirement for hiring, retention, and
sometimes for the renewal of professional licenses.
• An APO or AIPO is a professional society duly accredited by the
Professional Regulation Commission (PRC) and the respective
Professional Regulatory Board (PRB)
According to Ryan Tracey, the benefits of membership in professional
organizations are the following:

PROFESSIONALISM
➢ Professional organizations have their own rules and regulations and
code of ethics
➢ And as a member, one must adhere to these rules and code of
ethics, hence you are showcasing professionalism
➢ It is considered as the least in terms of value among all these
benefits,
 ➢ This is an advantage for employers since adherence to prescribed
rules shapes the conduct of a professional
EDUCATION
➢ In a way of lifelong learning.
➢ Professional organizations organize seminars, trainings, workshops
and so on for their members.
➢ Through these activities, professionals are acquiring continuous
knowledge and skills
PERKS
➢ Perks usually come in monetary discounts on registration fees for
development activities of the organization.
➢ These discounts are exclusive only to members of the organization
NETWORKING
➢ Gatherings and other activities can be potential avenues for creating
long-term linkages and connections with other professionals in the
field.
➢ Hence, it provides opportunities for building networks in the field
PROFILE
➢ Members in a professional organization can also build the career
portfolio of a professional.
RECOGNITION
➢ Professional organizations recognize their outstanding members and
leaders in the practice and special fields such as research, public
service, and community engagements through awards.

TYPES OF PROFESSIONAL ORGANIZATIONS

Professional organizations are classified based on their main function.
Accrediting Organizations
• Accredit curricular programs in educational institutions
• Membership is limited and is usually institutional
Credentialing/Certifying Organizations
• Provide certification examinations for professionals
Professional Societies
 • Organizations which contribute to the development of a specific
group of professional
• These organizations provide/contribute to the professional growth of
a professional
• PAMET - Philippine Association of Medical Technologists
• PASMETH - Philippine Association of Schools of Medical
Technology and Public. Health and Hygiene
Professional Journals
• These are publications containing scholarly studies on specific
professional fields.
• These journals publish articles and reviews of books and past
articles and serve as a forum for new articles.
• Journals help disseminate published works to other practitioners in
the field.
• These are prepared by professionals in the field and are peer-
reviewed by experts.
• It helps build the career portfolio of a professional.
PAMET
The Philippine Association of Medical Technologists, Inc.
Founded on September 15, 1963
Founder of PAMET - Dr. Crisanto G. Almario (Father of PAMET)
First National Convention – September 20, 1964
First President – Charlemagne Tamondong
Registered at the Securities and Exchange Commission (SEC) on October
14, 1969
➢ National professional organization of Registered Medical
Technologists in the Philippines.
➢ At 10:00am, by Dr. Almario – a Pharmacy graduate who worked as
a laboratory technician at SLH.
➢ It was at that point he noticed the very degraded classification of
workers performing this particular job. So he felt the need to
standardize the profession, and to elevate its category into a more
dignified one.
 ➢ Without wasting time, he immediately grabbed the opportunity and
moved to organize the national organization for the medical
technology workers.
➢ First National Convention which was held at the conference hall of
the Far Eastern University Hospital
➢ SEC - agency of the Government of the Philippines responsible for
regulating the securities industry in the Philippines. In addition to its
regulatory functions, the SEC also maintains the country's company
register.
➢ Its major functions include registration of securities, analysis of every
registered security, and the evaluation of the financial condition and
operations of applicants for security issue.
➢ The only accredited professional organization of Registered Medical
Technologists in the Philippines
✓ 46 provincial chapters
✓ 4 international chapters
✓ 13,000 members
September 15, 1963 – first organizational meeting of PAMET at Public
Health Laboratory
➢ (Singapore, Eastern Region Middle East, Western Region Middle
East, USA)
➢ It is affiliated not only with other local professional organizations, but
also with international organizations.
➢ Located at Sta. Cruz Manila
➢ With a total of 20 representatives, 9 from schools offering medtech
and 11 from allied medical professions

Circle – continuous involvement where

practice and education must always be
integrated
Triangle – trilogy of love, respect, and
integrity
Microscope and snake – science of Medical
Technology
Green – color of health
1964 – year the first PAMET Board was
elected
 ➢ Doctors' symbol: A staff or rod with a snake curled around it. This is
the Rod of Aesculapius (also called Asklepios), the ancient mythical
god of medicine. ... The caduceus is usually depicted with
two snakes and a pair of wings and is often used mistakenly as
a symbol of medicine
➢ The Rod of Asclepius symbol is often confused with the
Caduceus, symbol of commerce associated with the Greek god
Hermes. The Rod of Asclepius combines the snake with a rod, a
simple tool. The serpent with its change of skin symbolizes rebirth
and fertility.
➢ The caduceus is often incorrectly used as a symbol of healthcare
organizations and medical practice, particularly in the United States
of America, due to confusion with the traditional medical symbol, the
Rod of Asclepius, which has only one snake and is never depicted
with wings

INTEGRITY
It is the strict adherence to a
moral code, reflected in
transparent honesty,
truthfulness, accuracy,
accountability for one’s actions,
and complete harmony in what
one thinks, says, and does

PROFESSIONALISM
It refers to the positive traits and values, moral responsibility, social
responsiveness, and behavioral outlook which makes one highly
respectable and credible
COMMITMENT
It is the unconditional, unwavering, and selfless dedication that one builds-
in into the practice of the profession characterized by initiative, creativity,
and resourcefulness to bring about quality health care and service to the
public
EXCELLENCE
It is the high-quality performance by advocating and adhering to
international standards making services globally comparable and
competent
UNITY
It is the necessary linkage, support, involvement, and sharing that will
increase the success and advancement of every individual member and the
association in general

Roster of PAMET Presidents

Charlemagne T. Tamondong
1963-1967
Emergence of the Profession
First PAMET President

Nardito D. Moraleta
1967-1970
Professional Recognition
➢ RA 5527
➢ SEC Registration of PAMET
➢ PAMET chapters: Cebu and Baguio
➢ First MT Board exam

Felix E. Asprer
1970-1971, 1973-1977
Legislative Agenda
➢ Accreditation of PAMET by PRC
Bernardo T. Tabaosares
1971-1973
Celebration of the Profession
➢ Teves Law – salary of medical
professionals
➢ Philippine Medtech week – September
1972

Angelina R. Jose
1973
Career Advocacy
➢ She has the shortest term
➢ Jan-Sept 1973

Venerable C.V. Oca

1977-1981
Educational Enhancement
➢ Monthly seminars, medical missions
for the poor and less fortunate & quiz
contests
Carmencita P. Acedera
1982-1991
Image Building
➢ She has the longest term as PAMET
president
➢ Salary standardization of government MT
from salary grade 13 to 22
➢ Hazard pays to at least 25% of the basic
monthly salary of MT in government practice
➢ Sportfest & inner-collegiate quiz in MT week
➢ Composition of the PAMET hymn

Marilyn R. Atienza
1992-1996
Proactivism

Norma N. Chang
1997-2000
International Leadership
Agnes B. Medenilla
12001-2002, 2005-2006
Organizational Dynamism

Shirley F. Cruzada
2003-2004
Interdisciplinary Networking

Leila M. Florento
2007-2013
Global Perspectives

Romeo Joseph J. Ignacio

2013-2015
Golden Celebration
 Ronaldo E. Puno
2015-Present
Empowerment

The Philippine Association of

Schools of Medical Technology and
Public Health, Inc.
Established in 1970
Purpose: to maintain the standards of
medical technology/public health
education
➢ National organization of
recognized schools of medical
technology and public health in
the Philippines
➢ Hygiene
➢ Foster closer relations among
medical technology schools

May 13, 1970

Dr. Narciso Albarracin, then Secretary of the Department of Education,
designated Dr. Serafin Juliano and Dr. Gustavo Reyes to organize an
association of deans/heads of schools of medical technology and public
health.
June 22, 1970
First organizational meeting was held at University of Santo Tomas
President: Dr. Gustavo Reyes
V. President: Dr. Serafin Juliano
Secretary/Treasurer Dr. Velia Trinidad
PRO: Dr. Faustino Sunico
 ➢ First set of officers
➢ First members: UST, FEU, CEU, SJDEFI, PWU, and Martinez
Memorial Colleges (MMC)
October 6, 1985
PASMETH was formally registered at SEC through the Committee on
Legislation chaired by Mr. Cirilo S. Cajucom, with the help of legal counsel
Atty. Dexter Bihis.
It was also the finding organization of the ASEAN Association of Schools of
Medical Technology (AASMT) through the initiatives of Dean Bernard
Ebuen, Dr. Jose Jurel Nuevo, and Dr. Anacleta Valdez.
MEANING OF LOGO
Circle – continuity of learning and the never-ending quest for excellence in
the academic field
Diamond – the four corners represent the four objectives of the Association
Microscope – represents the field of Medical Technology and Public Health
1970 – the year the Association was founded

The Philippine Society of Medical

Technology Students
It was first organized in 2002 during the
leadership of Dr. Zenaida Cajucom
First advisers: Prof. Marilyn Bala, Prof.
Nova Aida Cajucom, and Prof. Zennie
Aceron
Reorganized by: Dir. Magdalena
Natividad, and Dean Bernard Ebuen
on November 25, 2006 at FEU-NRMF

➢ National organization of all medical technology students under the

supervision of PASMETH
➢ February 24, 2009 – PHISMETS held its first Medical Technology
Student Congress at Our Lady of Fatima University in Valenzuela
City
➢ PHISMETS also conducts an annual Medical Technology Student
Leadership Training and Strategic Planning during the month of May
➢ May 13, 2010 – first PHISMETS Leadership Training and Seminar at
Benguet State University
 ➢ Council of Student Advisers (COSA)
➢ They help to facilitate and oversee the PHISMETS national
organization and its local chapters
MEANING OF THE LOGO
• 3 circles – continuous active involvement of Luzon, Visayas, and
Mindanao in the national transforming venue of Medical Laboratory
Science students
• Laurel – nature and the continuation of life every year
• Green Letters – color of health
• 5 bubbles from a test tube – 5 objectives embody in the constitution
of the organization
• 15 interconnected molecules outside a test tube – unity of 15 board
schools exploring various possibilities and aiming towards the integral
growth and holistic development of medical laboratory science
students
• Microscope – medical laboratory science