WEEK 2: INTRODUCTION 2.

CREDENTIALING/CERTIFYING ORGANIZATIONS

- Provide certification examinations for the

PURPOSE OF PROFESSIONAL ORGANIZATIONS
- Educate the public on relevant issues in the
industry
- Represent the interests in legislative bodies and
international societies
professionals
- These professionals are required to renew
their license within a specified duration
Ex. American Medical Technologists (AMT)
American Society for Clinical Pathology (ASCP)

- Provide professional growth through workshops, International Society for Clinical Laboratory
trainings, seminars and publishing research Technology (ISCLT)
journals
National Certifying Agency for Medical Laboratory
BENEFITS OF MEMBERSHIP IN PROFESSIONAL Personnel (NCA)
ORGANIZATIONS
3. PROFESSIONAL SOCIETIES
1. Professionalism - to adhere to the set of
- These are organizations that contribute to
rules or code of ethics prescribed by
the continued development of a specific
professional society
group of professionals
2. Education - Organizes CPD activities for
their members Ex. Philippine Association of Medical Technologists
3. Perks - In the form of monetary discounts on (PAMET)
registration fees
4. Networking - Gatherings and other activities Philippine Society of Pathologists (PSP)
build long-term linkages and connections
Some more examples of LOCAL
with other professionals in the field
professional organizations
5. Profile - Speaking engagements, career
specialization, research journal publications,
scholarships, training abroad Abbreviation Professional Society
6. Recognition - Organization recognize their
outstanding members and leaders in the PAMET Philippine Association of Medical
practice and special fields. This enhances Technologists, Inc.
one’s professional profile
PASMETH Philippine Association of Schools
TYPES OF PROFESSIONAL ORGANIZATIONS
of Medical Technology and
1. ACCREDITING ORGANIZATIONS
Public Health, Inc.
- Accredit curricular programs in educational
institutions BRAP BioRisk Association of the
- To verify the educational institution’s Philippines
compliance to the standards of quality
education
PBCC Philippine Blood Coordinating
Ex. Philippine Accrediting Association of Schools, Council
Colleges, and Universities (PAASCU)
PCQACL Philippine Council for Quality
Philippine Association of Colleges and Universities
Assurance in Clinical
Commission on Accreditation (PACUCOA)
Laboratories
 stakeholders of health and make its services
PSM Philippine Society of important to the beneficiaries of its services.
Microbiologists
CORE VALUES
PhBBA Philippine Biosafety and INTEGRITY
Biosecurity Association Integrity is the strict adherence to a moral code,
reflected in transparent honesty, truthfulness,
accuracy, accountable of one’s actions and
complete harmony in what one thinks, says, and
does
PAMET LOGO
PROFESSIONALISM
Professionalism refers to the positive traits and
values, moral responsibility, social
responsiveness and behavioral outlook which
makes one highly respectable and credible

COMMITMENT
Commitment is the unconditional, unwavering
and selfless dedication that one builds-in into the
practice of the profession characterized by
Symbolizes the continuous initiative, creativity and resourcefulness to bring
involvement where practice about quality health care and service to the
CIRCLE and education must always be public
integrated
EXCELLENCE
The trilogy of love, respect and Excellence is the high-quality performance by
TRIANGLE integrity advocating and adhering to international
standards making services globally comparable
Symbolizes the science of competence
MICROSCOPE medical technology profession
AND SNAKE UNITY
GREEN Color of health Unity is the necessary linkage, support,
involvement and sharing that will increase the
Year of PAMET election success and advancement of every individual
1964 member and the association in general

VISION
WEEK 3: INTRODUCTION
PAMET shall be the constant prime mover in INTRODUCTION TO MEDICAL TECHNOLOGY
advancing the Medical Laboratory Science MEDICAL TECHNOLOGY
profession for the continuous growth and • (aka Medical Laboratory Science,
development of its members. Biomedical Science, Clinical Laboratory
Science)
MISSION
• Branch of medical science that applies
To realize its vision, PAMET shall be an physical and natural science principles in the
association that will uphold professional core values; performance of laboratory procedures for the
develop and sustain comprehensive programs to diagnosis and treatment of disease
enhance competencies of the Medical Laboratory (Heinemann, n.d.)
Science professionals; collaborate with the different
 • The science of performing laboratory
procedures and analyses for the diagnosis
and treatment of a disease, and
maintenance of health (Anne Fagelson, n.d.
• An auxiliary branch of laboratory medicine
which deals with the examinations by various
chemical, microscopic, bacteriologic and
other medical laboratory procedures or
technique (RA 5527, 1969)
MEDICAL TECHNOLOGIST
• A health care professional who plays a key
role in the modern laboratory – performs
various clinical, laboratory procedures that
helps the physicians to diagnose, monitor,
and treat a certain human condition.
• A person who engages in the work of medical
technology under the supervision of a
pathologist, and a graduate of bachelor in
medical technology who passed the board
exam. Also regarded as the living clinical eye
(RA 5527, 1969)
PATHOLOGIST
A duly registered physician who is specially
trained in methods of medicine, or the gross
examination of tissues, and function of human body
to diagnose certain disease (RA 5527, 1969)
HISTORY OF MEDICAL TECHNOLOGY
MEDICAL TECHNOLOGY IN ITS EARLIEST ONSET
460 BC
Greek physician Hippocrates the father of
scientific medicine, adopt the triad of regimen, in
treating diseases and infections with the use of
drugs, surgery, and bloodletting.
1550 BC
Vivian Herrick shown the incidence of intestinal
parasitic infection caused
by Ascaris lumbricoides and Taenia species.
EBERS PAPYRUS
a book that describes the treatment of diseases
and the three stages hookworm infection.
ANENZOA
a Arabian physician, proved that scabies are
caused by parasites.
DISEASE
negative interaction between the environment
and the body
HIPPOCRATES
Father of Medicine
GALEN
Greek physician and Philosopher
MEDIEVAL EUROPE
water casting (uroscopy)
MEDIEVAL PERIOD (1098-1438)
- urinalysis became a fashion of practice.
- mentioned in the book of Ruth Williams
entitled ‘’An Introduction to the Profession of
Medical Technology.
14TH CENTURY
- Anna Fagelson strongly confirmed the
beginnings of medtech when she correlated
that the cause of death by Alexander Gilani, a
laboratory worker in the university of bologna,
was due to laboratory-acquired infection.
11TH CENTURY
medical practitioner were not allowed to conduct
physical examination of patient’s body
17TH CENTURY ANTON VAN LEUWENHOEK
- invented the first functional crude microscope.
- First scientist to observe and describe the
appearance of red blood cell.
MARCELO MALPHIGI
Father of pathology and histology.
 MEDICAL TECHNOLOGY IN THE 18TH CENTURY
1821-1902
- Rudolf Virchow was recognized as the
‘’father of microscopic pathology’’ also the
first scientist to emphasized the study of
manifestation of diseases and infections
1850
- dept. of Pathology was established
Dr. Calvin Ellis
• the first to utilize the microscope in
examining specimen at
the Massachusetts General Hospital.
Dr. William Occam - used lab findings as
preliminary evidence in diagnosing and evaluating
disease
18th century – mechanical techniques and cadaver
dissection
APOTHECARIES ACT OF 1815
• initiated by Baron Karl von Humbeldt.
• It was formulated for the regulation of the
practice of apothecaries throughout England
and Wales.
• It is the beginning of regulation of the medical
profession in UK.
Herman Fehling - performed first quantitative test
for urine sugar.
MEDICAL TECHNOLOGY IN THE USA
First chemical laboratory related to medicine
• established at the University of
Michigan by Dr. Douglas.
• He pioneered laboratory instruction in this
well-equipped laboratory.
1878 - Dr. William H. Welch
• established another laboratory
the Bellevue Hospital Medical College.
• He gave the first laboratory course in
Pathology ever offered in an American
Medical School.
19th century – use of machines
• John Hutchinson’s Spirometer
• Jules Herisson’s Sphygmomanometer
• Increased demand of health practitioners
due to increasing number of patients.
• The growth impelled the need for technicians
to be proficient in the use of technology.
UNIVERSITY OF PENNSYLVANIA’ WILLIAM
PEPPER LABORATORY OF CLINICAL MEDICINE
John Kolmer – The Demand for and Training of
Laboratory Technicians
1920, Divisions of lab: Clinical pathology,
Bacteriology, Microbiology, Serology and Radiology
1922, ASCP was founded
• Maintaining cooperation between physicians,
pathologists, medical technologists and
laboratory technicians.
American Society for Medical Technologists à
American Society for Clinical Laboratory Science
(originally formed as a subgroup of ASCP)
1885- Dr. W. Welch
• became the first professor of pathology at
the John Hopkins University
Dr. Simon Flexner
• the first pathologist of the John Hopkins
Hospital Department of Pathology
1896 - Dr. William Osler
• first clinical laboratory opened at the John
Hopkins Hospital- routine examination were
carried out, special attention being given to
the search for malarial parasites in blood.
at 1896
 • Another clinical laboratory was also opened
at the University of Pennsylvania (William
Pepper Laboratory).
Burdon Sunderson
• obtain significant results in his works in
medicine, he initiated the use of laboratory
animals for experimentation as part of his lab
examination.
1896
• first clinical laboratory was opened
at John Hopkins Hospital.
1908 - Dr. James C. Todd
• wrote the book “A Manual of Clinical
Diagnosis”.
• retitled “Clinical Diagnosis by Laboratory
Methods” in its 6th edition by Dr. Todd and Dr.
Arthur Sanford.
• This book became the standard reference for
laboratories.
1919
• 100 technicians, all male employed in the
United States.
• increased to 3,500 in 1920.
1922
• 3,035 hospitals had clinical laboratories.
1915
• the state legislature of Pennsylvania enacted
a law requiring all hospitals and institutions
to have an adequate laboratory and
to employ a full time laboratory technician.
1922, University of Minnesota
• one of the first school to trained
laboratory workers.
• A course bulletin was titled “ Courses in
Medical Technology for Clinical and
Laboratory Technicians.
1923, University of Minnesota
• first to offer a degree level program.
1940
• United States required a 2-year collegiate
education and a twelve-month actual training
in the laboratory for the preparation of its
practice.
1950
• Standard curriculum was formalized in
preparation for a Bachelor of Science
degree.
MEDICAL TECHNOLOGY IN THE PHILIPPINES
• UST, founded 1611
Vaccine lymph in 1806 – 122 regular vaccinators
(vacunadores)
Laboratorio Municipal de Manila – established
by Spanish (Gen. Antonio Luna)
End of World War II (1939-1945)
• Medical Technology practice was introduced in
the Philippines by the 26th Medical Infantry
of the 6th US Army
• The US Army established the first Clinical
laboratory at Quiricada St., Sta. Cruz,
Manila where the Manila Public Health
Laboratory (a division of the Manila Health
Department) is presently located.
February 1944
• laboratory (MPHL) offered training program to
high school graduates.
June 1945
• US Army left the Clinical Laboratory and
endorsed it to the National Department of
Health.
• The Department rendered the laboratory non-
functional for sometime.
October 1, 1945, Dr. Alfredo Pio de Roda
 • organized the Medical laboratory and was
given the name Public Health Laboratory.
• He was assisted by Dr. Mariano Icasiano who
was then the Manila City Health officer.
1947
• training of medical technicians started
under Dr. Pio de Roda and Dr. Prudencia
C. Sta. Ana.
• Trainees were mostly high school and
paramedical graduates. (No definite period of
training was set and no certificates were given
to trainees.
1954
• a six-month laboratory training with
certificates upon completion was given to the
trainees.
• Dr. Sta. Ana prepared the syllabus for the
training program.
Dr. Tirso Briones
• joined the two doctors in the training program
at the public health laboratory.
Philippine Union College and Manila Sanitarium
• offered the first B.S. degree course in
Medical Technology.
1956, Dr. Jesse Umali
• first graduate of B.S. MedTech from PUC;
now OB-Gynecologist in the USA.
• He is also the owner of the Omega
Laboratory at Vito Cruz, Manila.
Mrs. Willa Hilgert Hedrick
• started to offer the medical technology
course (pioneered medical technology
education) under PUC
• later joined by Antoinette McKelvey who was
trained by Dr. Papanicolau in teaching
Microbiology and histopathology.
l5 years curriculum was first offer to PUC and
manila sanitarium.
1957, Dr. Antonio Gabriel and Dr. Gustavo U.
Reyes
• (UST Faculty of Pharmacy) offered Medical
Technology as an elective subject to 4th and
5th year B.S. Pharmacy students.
Rev. Fr. Lorenzo Rodriguez
• decided to offer Med.Tech. as a course at
UST.
June 17, 1957
• issuance of temporary permit to first to third
year students (Dep.Ed.)
1961, Dr. Horacio A. Ylagan and Dr. Serafin J. Ju
liano
• started offering B.S. MedTech at FEU under
the College of Medicine.
• Their first graduates was in 1963.
U.P. Manila offers similar course but the degree
being conferred is B.S. Public Health
Our Lady of Fatima University- offer the course
Medical Technology in the year 2000.
Postgraduate studies for B.S.
Medical Technology
Among the schools that offered the course were the
following:
- UST Graduate School
- Philippine Women’s University
- Manila Central University
- Our Lady of Fatima University
- Trinity University of Asia
- U.P. Manila offered 1year, non-thesis degree
in Masters in Public Health
 WEEK 3
A medical technologist is a highly skilled
health professional who tests and analyzes blood,
other body fluids, and tissue samples. Medical
technologists are responsible for operating and
maintaining the equipment used to analyze
specimens and ensuring that tests are completed in
a correct and timely manner.
Also Known As
• Clinical laboratory scientist
• Medical laboratory scientist
• Medical laboratory technologist
Medical technologists work in all areas of the
lab, including immunology, microbiology, genetics,
histology, hematology, chemistry, toxicology, and
blood banking.
CLINICAL PATHOLOGY
In clinical pathology , the technologist would
conduct and oversee lab tests on body fluids. The
tests are performed to identify markers for infectious
and non-infectious diseases. Among the specimens
a medical technologist will typically analyze are:
• Blood
• Urine
• Sputum (phlegm)
• Stool (feces)
• Spinal fluid
• Pleural fluid
• Peritoneal fluid
• Joint fluid
• Bone marrow
ANATOMICAL PATHOLOGY
Anatomical pathology involves the
examination of tissues taken from the body during
a biopsy or surgery. While some of the diagnostic
tests can be performed by a technologist, others
require the expertise of the pathologists.
THE TYPES OF EXAMINATIONS A TECHNOLOGIST
MAY PERFORM OR ASSIST IN INCLUDE:
• Gross examination: Examination of tissue with
the naked eye
• Histology: Examination of tissue under a
microscope
• Cytopathology: Examination of loose cells
under a microscope
• Electron microscopy
• Cytogenetics: Visualization of chromosomes
using various techniques
Medical technologists typically work under a
pathologist but may be independently tasked to
operate a lab itself. Among their duties, medical
technologists will oversee the work of lab
technicians in addition to managing their own duties.
Although the pathologist is ultimately in charge
of the lab and its staff, the medical technologist will
usually be the one who ensures that the lab operates
smoothly, safely, and properly on a day-to-day
basis. This includes setting up, calibrating, and
sterilizing lab equipment, as well as analyzing and
checking the accuracy of lab reports.
Most medical technologists operate behind the
scenes and do not have direct contact with patients.
The health professionals generally tasked with
obtaining specimens are and lab assistants. Other
specimens are delivered directly to the lab by
doctors and surgeons.
PROFESSIONAL ORGANIZATION
• Is a group composed of professionals with in a
career field who come together for individual
professional development, advancement,
networking and collaboration.
• They provide opportunities for professional
growth and continuing education by offering
workshops, trainings, seminars and publishing
journals
TYPES OF PROFESSIONAL ORGANIZATION
I. ACCREDITING AGENCIES
• Organizations that accredit curricular
programs in educational institutions.
• CHED – Main accrediting agency of Med
Tech schools in the Philippines
II. CREDENTIALING/ CERTIFYING AGENCIES
 • provide certification examination for
professionals (Medical Technologists and
other laboratory professionals)
Local credentialing agency
• Professional Regulation Commission –
(PRC)
International credentialing agency
• AMT- American Medical Technologists
• ASCP- American Society of Clinical
Pathology
• ISCLT- International Society for Clinical
Laboratory Technology
• NCA- National Certifying Agency for
Medical Laboratory Personnel
III. PROFESSIONAL SOCIETIES
• Professional organizations that contribute to
the continued professional development of a
specific group of professionals.
IV. FOREIGN PROFESSIONAL SOCIETIES
• Individual countries and states with existing
laboratory professionals.
PASMETH
PHILIPPINE ASSOCIATION OF SCHOOLS OF
MEDICAL TECHNOLOGY AND PUBLIC HEALTH
• National organization of 80 recognized
schools of MT in the Philippines
• Formed in May 13,1970 thru Dr. Narciso
Albarracin, Dr. Serafin Juliano, and
Gustavo Reyes
• June 22, 1970- 1st organizational
meeting at UST
• Dr. Gustavo Reyes- President
• Dr. Serafin Juliano- VP
• Dr. Velia Trinidad- Sec/Treas
• Dr. Faustino Sunico- PRO
• May 7, 1971 – 1st annual meeting at UST
• April 30, 1972- new sets of officers
• Dr. Gustavo Reyes- President
• Dr. Claro Cabrera- VP
• Dr. Elvira Silva- Sec
• Dr. Faustino Sunico- PRO
OTHER PASMETH PRESIDENTS
• Dr. Ibarra Panopio (1973-1974)
• Dr. Angelita G. Adeva (1974-1975)
• Dr. Elizabeth M. del Rio (1977-1981)
• Dr. Gustavo Reyes-Dr. Cabrera (1981-
82)
• Dr. Elizabeth M. Del Rio (1982-83)
• Dr. Norma V. Lerma (1983-84)
• Dr. Vivencio T. Torres (1984-85)
• Prof. Nardito Moraleta (1985-1988)
• Dean Norma Chang (1988-95)
• Prof. Rodolfo R. Rabor (1996-1999)
• Dr. Nini Festin-Lim (1999-2002)
• Dean Zenaida Cajucom (2002-April
2010)
• Dir. Magdalena Natividad (2010-2011)
• Dean Bernard Ebuen – (2011-present)
PASMETH
MR BERNARD EBUEN- PASMETH President
PASMETH OBJECTIVES
• To encourage a thorough study of the needs
and problems of Medical Technology and
public health education and to offer solutions
to them
• To work for the continuous development of
MT and PH education in order that the
profession will be of maximum service to the
country
• To take a united stand in matters which
affects the interest of MT and PH education
• To seek the advice, aid and assistance from
any government or private entity for the
fulfilment of the aims and purposes of the
association
PASMETH HYMN
• Result of Hymn writing contest during the
PHISMETS Annual Student Congress at
the Ynares Center last February 22, 2014
 • Written by Red Aian Caragdag and
Kenneth Bryan Zarate
• First performed by the UST MT Choir during
the 44th PASMETH Annual Convention at
Lyceum of the Philippines Univ., Batangas
on May 5,2014
• PAMET- Philippine Association of
Medical Technologist Organization
BRIEF HISTORY OF PAMET
MR. CRISANTO G. ALMARIO
• Organized PAMET
• Father of PAMET at the Public Health
Laboratory in Sta. Cruz, Manila on
September 15, 1963
MR. CHARLEMAGNE TAMONDONG
• elected as the first President during its first
convention at the Far Eastern University on
September 20, 1964 and on June 21, 1969
Republic Act 5527- “Philippine Medical Technology
Act” was enacted into law
• It was incorporated and registered at the
Securities and Exchange Commission on
October 14, 1969 with Reg. No. 39570,
during the presidency of Mr. Nardito D.
Moraleta.
PAMET
• officially recognized as the only Accredited
Professional Organization (APO) of
registered Medical Technologists in the
Philippines on June 22, 1973 where P.D.
223 was approved creating the Professional
Regulation Commission (PRC).
PAMET AFFILIATIONS
LOCALLY:
• Council of Professional Health Associations
(COPHA),
• Philippine Federation of Professional
Associations (PFPA),
• Council of Health Agencies (CHAP),
• Philippine Council for Quality Assurance
in Clinical Laboratories (PCQACL) and
• Alliance of Allied Health Organizations of the
Nation (AAHON).
INTERNATIONALLY:
• ASEAN Association of Clinical Laboratory
Sciences (AACLS),
• Asia Association of Medical Laboratory
Scientists (AAMLS),
• International Federation of Biochemical
Laboratory Scientists (IFBLS),
• Asia Pacific Federation of Clinical
Biochemistry (APFCB) and
• International Federation in Clinical
Chemistry, and with link with PAMET USA
and PAMET Singapore
PAMET
PHILIPPINE ASSOCIATION OF MEDICAL
TECHNOLOGISTS
• National organization of all registered
medical technologists in the Phils.
• Organized by Crisanto Almario on
September 15, 1963 at the Public Health
Laboratory
• Crisanto Almario – Father of PAMET
• Sept 20, 1964 – First Convention held at
FEU,Morayta
• October 14, 1969 – Registered with the SEC
through the leadership of Mr. N. Moraleta
• June 21, 1969 – RA 5527 was enacted into
law
PRESIDENTS OF PAMET
• Charlemagne Tamondong – 1963-1967
• Nardito Moraleta- 1967-1970
• Felix Asprer-1970-71,1973-77
• Bernardo Tabaosares- 1971-73
• Angelina Jose- Jan.-Sept. 1973
• Venerable C.V. Oca – 1977-Feb 1982
• Carmencita Acedera- 1982-1992
• Marilyn Atienza – 1992- 1996
• Norma Chang- 1996-2000
• Agnes Medenilla- 2000-2002, 2004-06
• Shirley Cruzada- 2002- 2004
• Leila Monseratt Florento- 2007-2012
• Romeo Joseph Ignacio – 2012- June 2015
• Ronaldo Puno - present

PAMET HYMN
BELOVED PAMET
From various lands, races and places
With grateful hearts we raise our voices
This day to our beloved PAMET
From whence unity and love cometh
We join together in brotherhood
To live up to thine ideals we should
In fields advancement and learning
Thy noble goals maybe our bearing
Loyal and true we’ll be to thee
Beloved PAMET this we say,
For service to God and humanity,
With joy we sing for thee ‘til eternity
PAMET HYMN
• “Beloved PAMET” was written by Hector G.
Gayares, Jr. and placed into music by
Francis Jerota Pefanco. Both were Medical
Technology students of Philippine Union
College (PUC), now known as Adventist
University of the Philippines, at the time of
the composition.
• Based on a circular passed by PAMET
sometime in summer of 1989 summoning a
hymn composition that would depict the
ideals and principles of the association,
Hector decided to scribble a few hymn lines.
With a sustaining inspiration, the two stanzas
of the hymn were completed. Hence, the
hymn was presented to Francis, his
classmate, who rushed to the piano and tried
to fit in some music to the words, thus notes
flowed through the lyrics of the refrain
• Suggestions and advice from another Med.
Tech. student named Roselyn P. Villones
who edited the lyrics of the hymn finally
completed the musical score
• Following an important accomplishment of
these musically talented Medical Technology
students, the hymn was first heard in public
during the 25th National Convention of
the Philippine Association of Medical
Technologists (PAMET) at the Philippine
International Convention Center (PICC)
on November 22, 1989. The hymn was sung
by a 20-member choir composed of Medical
Technology interns and clinical students in
four voices
• The applause earned by the rendition of the
hymn spoke for a gracious endorsement by
the audience.
• The hymn, true enough to be stately,
dignified and reverent has answered
PAMET’S yearning for a hymn of its
own…PAMET has now a song to sing to the
world Intended for the songwriting
competition for the PAMET Hymn, the
musical piece submitted by the PUC
students was accepted by the PAMET
Board.
MEDICAL TECHNOLOGIST'S PRAYER
God, who by calling us to the vocation of a medical
technologists, has placed upon us the obligation of
being a constant help in the scientific care of the
sick, grant us by thy divine light a deep insight into
the serious responsibilities of our task
By thy divine wisdom, awaken in us a growing zeal
and determination to increase our knowledge of
how to search for the underlying causes of sickness
and disease; how to recognize the evidence of
physical changes; how to make important chemical
analyses, and other valuable test so helpful in
caring for the sick
By thy divine love, permit us in this way to share
with those who directly care for the sick, that thus
we may be of constantly working through the
eternal physician, Christ our Lord, Amen
 PAMET PRAYERS
O Lord, allow us to express our thanksgiving for the
wonderful gifts of wisdom, perseverance and
dedication that you have implanted in us.
Guide us in our deliberation and discussion so that
we could welcome suggestions and criticisms, good
or bad. Help us listen, understand, support and
respect one another, empower us to develop our
self awareness and maturity
Guide us to move in one direction for a greater
service to others through the Medical Technology
Profession This we ask through Christ. AMEN
Thank you Lord:
For giving us the solutions; for giving us the time
and the strength to perform all our duties and for
the good camaraderie and understanding amongst
us all.
Thank You Father in JESUS HOLY NAME, AMEN
PHISMETS
PHILIPPINE SOCIETY OF MEDICAL TECHNOLOGY
STUDENTS
Under PASMETH:
• Organized in 2002 by Dr. Zenaida Cajucom
• Reorganized on November 25,2006 at FEU-
NRMF by Dir. Magdalena Natividad and
Prof. Bernard Ebuen
• First Student Congress – February 24,
2009
PHISMETS LOGO
3 CIRCLES
Active involvement of Luzon Visayas and
Mindanao
LAUREL
Nature and continuation of life
GREEN LETTERS
Color of life
5 BUBBLES
5 objectives embodied in the constitution
15 INTERCONNECTED MOLECULES
unity of 15 board schools exploring various
possibilities and aiming towards the integral
growth and holistic development of MLS students
MICROSCOPE
signifies MLS
Here are some benefits to joining a professional
organization
Jobs
Many professional organizations help their
members find jobs, or at the least, offer up job
listings that other members may be offering.
Mentoring
Mentoring is the cornerstone of many
professional organizations when it comes to working
with younger members. You may never get in the
room with someone at the top of your field, for a very
long time. But professional organizations have the
ability to pare you with someone much more
experienced
Professional Development
Many organizations offer professional
development via courses, workshops, publications,
and information on their website shared only with
members. They also keep members up to date on
industry trends and how to deal with them. Some
organizations (take the National Association of Black
Journalists for example) offer news and print
coverage of their annual conferences, run by
students—which is an excellent opportunity to gain
experience.
Networking
Most organizations have an annual
conference. This is an opportunity for you to mix and
mingle with others in your field in both professional
and leisure settings. There is also often a job fair
where you can make contact and stay up to date with
the very people who hire – even if they’re not hiring
right now. In fact, some people find recruiters follow
their career and stay updated when you stop by their
booth at the job fair. They may be keeping an eye on
you until they are ready to finally offer you a job.
Scholarships
For the youngest of members (high school
and college), scholarships may be the primary
reason to join a professional organization. Many
offer scholarships to the new members studying to
enter the field
CONTINUING PROFESSIONAL DEVELOPMENT
ACT- CPD LAW R.A. 10912
• An act mandating and strengthening the
continuing professional development
program for all regulated professions,
creating the continuing professional
development council, and appropriating
funds therefor, and for other related
purposes
• Be it enacted by the Senate and House of
Representatives of the Philippines in
Congress assembled
• It is hereby declared the policy of the State to
promote and upgrade the practice of
professions in the country.
• Towards this end, the State shall institute
measures that will continuously improve the
competence of the professionals in
accordance with the international standards
of practice, thereby, ensuring their
contribution in uplifting the general welfare,
economic growth and development of the
nation.
• Strengthening the CPD Program — There
shall be formulated and implemented CPD
Programs in each of the regulated
professions in order to:
i. Enhance and upgrade the competencies
and qualifications of professionals for the
practice of their professions pursuant to
the PQF, the AQRF and the ASEAN
MRAs;
ii. Ensure international alignment of
competencies and qualifications of
professionals through career progression
mechanisms leading to
specialization/sub-specialization;
iii. Ensure the development of quality
assured mechanisms for the validation,
accreditation and recognition of formal,
nonformal and informal learning
outcomes, including professional work
experiences and prior learning:
iv. Ensure maintenance of core
competencies and development of
advanced and new competencies, in
order to respond to national, regional and
international labor market needs; and
v. Recognize and ensure the contributions
of professionals in uplifting the general
welfare, economic growth and
development of the nation.
NATURE OF CPD PROGRAMS
The CPD Programs consist of activities that
range from structured to non-structured activities,
which have learning processes and outcomes.
These include, but are not limited to, the following:
(a) Formal learning;
(b) Nonformal learning;
(c) Informal learning;
(d) Self-directed learning;
(e) Online learning activities; and
(f) Professional work experience.
CPD AS MANDATORY REQUIREMENT
• in the Renewal of Professional License and
Accreditation System for the Practice of
Professions. — The CPD is hereby made as
a mandatory requirement in the renewal of
the PICs of all registered and licensed
professionals under the regulation of the
PRC
• MEDTECH 45 units (three years) required
prior to renewal of PRC license.
MEDICAL TECHNOLOGY
WHAT IS A MEDICAL TECHNOLOGIST?
• A person who engages in the work of medical
technology under the supervision of a
pathologist or licensed physician authorized
by the Department of Health in places where
there is no pathologist and who having
passed the prescribed course (Bachelor of
 Science in Medical Technology/Bachelor of
Science in Hygiene) of training and
examination is registered under the provision
of this RA5527
• Medical Technologist/ Laboratory Scientist
PHILIPPINE MEDICAL TECHNOLOGY ACT OF 1969
• A person shall be called to be in the practice
of medical technology within the meaning of
this Act, who shall renders any of the
following professional services for the
purpose of aiding the physician in the
diagnosis, study and treatment of diseases
and in the promotion of health in general:
• Examination of tissues, secretions and
excretions of the human body and body
fluids by various electronic, chemical,
microscopic, bacteriologic, hematologic,
serologic, immunologic, nuclear, and other
laboratory procedures and techniques either
manual or automated;
• Blood banking procedures and techniques;
Parasitologic, Mycologic and Microbiologic
procedures and techniques;
• Histopathologic and Cytotechnology;
• Clinical research involving patients or human
beings requiring the use of and/or application
of medical technology knowledge and
procedures;
• Preparations and standardization of
reagents, standards, stains and others,
provided such reagents, standards, stains
and others are exclusively for the use of their
laboratory; Clinical laboratory quality control;
• Collection and preservation of specimens
A PERSON WHO ENGAGES IN THE WORK OF
MEDICAL TECHNOLOGY:
- under the supervision of a pathologist or
licensed physician authorized by the
Department of Health in places where there
is no pathologist and
- who having passed the prescribed course
(Bachelor of Science in Medical
Technology/Bachelor of Science in Hygiene)
of training
- registered under the provision of this Act.
• • Hospital
MEDICAL TECHNOLOGIST
• Medical detectives Identify microorganisms
and analyze cells
• Do blood tests Measure substance in blood
and other fluids
• Identify organisms causing infection and
disease Operate complex apparatus,
instrument and machines
• Use standards and control to improve the
reliability of laboratory results Work under
pressure with speed and accuracy and
precision They adhere to high ethical
standards of performance
• An individual certified and registered with
PRC to run various tests under the
supervision of a registered medical
technologist or pathologist. May also log
specimens in the laboratory and prepare
samples for testing
WHAT IS A MEDICAL LABORATORY TECHNICIAN?
• A person certified and registered with the
Board as qualified to assist a medical
technologist and/or qualified pathologist in
the practice of medical technology as defined
in this Act.
• Histopathologic and Cytotechnology
procedure
• Collection and preservation of specimens
BSMT
• a baccalaureate degree program from a
college or university recognized by CHED,
completed a specified clinical internship in a
training laboratory by the Bureau of health
facilities and DOH Passed the licensure
examination administered by the Board of
Medical Technology of the Professional
Regulation Commission
CAREERS
JOB OPPORTUNITIES/PLACES OF WORK:
• Hospital
• Researcher
• Sales
• Academician
MEDICAL TECHNOLOGIST IN THE LABORATORY
• Clinical laboratory
 • Clinic • Communication skills
• Independent laboratory • Observant, motivated, precise, good
• Sales industry organizational skills
• Sales representative – • Clinical Chemistry – body fluid components
pharmaceutical, equipment, • Microbiology – pathogenic microorganisms
reagents • Hematology – whole blood analysis and
• Educational representative coagulation
• Research industry • Urinalysis
• Medical center research • Blood Bank (Immunohematology) –
• Industrial research transfusion related testing
• Academician • Serology (Immunology) – antibody studies
• College, chemistry, biology, medical • Specimen Collecting and Processing –
sciences includes phlebotomy
• Veterinary medicine
• Research WEEK 4
• Clinics • Medical terminology is derived primarily from
• Forensic the classic Greek and Latin languages.
However, it is not necessary to master either
CHARACTERISTICS / TRAITS of these languages to obtain a solid
• Physical stamina background in basic medical terminology.
• Good eyesight – normal color vision
• Manual dexterity • Medical terms consist of combinations of
• Good intellect and aptitude to biological three major word parts: prefixes, word roots,
science and caring attitude and suffixes. The same prefixes and suffixes
• Communication skills are frequently used with different word roots.
• Observant, motivated, precise, good Therefore, knowledge of a small number of
organizational skills commonly used prefixes, word roots, and
• Physical stamina suffixes can provide the phlebotomist with an
• Good eyesight – normal color vision extensive medical vocabulary and the
• Manual dexterity medical communication skills necessary for
• Good intellect and aptitude to biological successful job performance.
science and caring attitude
PREFIXES AND SUFFIXES
• Prefixes are letters or syllables added to the • Suffixes are letters or syllables added to the
beginning of a word root to alter its meaning. end of a word root to alter its meaning. In
The prefix usually indicates direction, medical terminology, suffixes often indicate a
number, position, size, presence or absence, condition or a type of procedure
or time
 WORD ROOTS AND COMBINING
FORMS
• Word roots are the main part of a word and • The combining form of a word root contains
may be combined with prefixes, suffixes, or a vowel, usually an “o,” which is used to
other roots facilitate pronunciation when the word root is
combined with another word root or a suffix
that does not begin with a vowel
 PLURAL FORMS
• In writing and using medical terms, it is should become familiar with the common
important to know that various medical terms word endings that have an unusual plural
have different plural forms. The phlebotomist ending.

PRONUNCIATION GUIDELINES
• Medical terms usually follow the rules of the
pronunciation of words in the English
language but may seem difficult to
pronounce initially. Helpful diacritical marks,
the macron and breve, may be used for long
and short vowel pronunciations. The macron
(–) indicates the long sound of vowels as in
fa- - tal The breve (˘) indicates the short
sound of vowels as fa- - ta˘l. Phonetic
spelling of syllables also can be used as a
pronunciation guideline as in AN-ti-BAH-dee.
Capitalization is often used to indicate the
emphasis on certain syllables as in MEM -
ber.
• Spelling a medical term correctly is important
because some medical terms are spelled
differently but are pronounced the same and
have a completely different meaning. For
example, ileum is part of the intestine and
ilium is part of the hip bone.
 ABBREVIATIONS
• Abbreviations are used to shorten words, medical phrases. Laboratory tests are
names, or phrases. Numerous abbreviations frequently abbreviated, and phlebotomists
are used in the medical field to represent must become familiar with these
terms, names of organizations, or common abbreviations
 KEY POINTS
• Medical terms consist of four-word parts:
o Prefix—a word part that is added at
the beginning of a word root that
changes the meaning to indicate
direction, number, position, size,
presence or absence, or time.
o Suffix—a word part that is added at
the end of a word root that changes
the meaning to indicate a condition or
type of procedure.
o Word root—the main part of a word
that is derived from the Greek or Latin
language and usually refers to body
components
o Combining form—the word root
plus a vowel, usually “o” that is used
to facilitate pronunciation when the
word root is combined with another
word root or a suffix that does not
begin with a vowel.
• When defining a medical term, begin at the
last part of the word (suffix), then define the
first part of the word (prefix), and last, define
the middle of the word (word root
• Various medical terms have different plural
forms.
• Correct pronunciation and spelling of
medical terms is critical to the correct
interpretation.
• Abbreviations are used to shorten words,
names, or phrases and are used to identify
laboratory tests, names of organizations, and
medical terms. The Joint Commission has
adopted an official “Do Not Use” list and a list
for possible future inclusions
WHAT IS BACHELOR OF SCIENCE IN MEDICAL
TECHNOLOGY?
• BS Medical Technology or MedTech is a
four-year degree program that provides
students with the necessary skills and
training in conducting laboratory tests. These
tests are used in detecting, diagnosing,
preventing, and treating various diseases.
• Medical Technologists perform lab
investigations based on specimens taken
from the human body such as urine, blood,
stool and other body fluids through the use of
medical equipment (e.g., analyzers,
microscopes and other precision
instruments.
• To be a professional, you must pass first the
Medical Technologist Licensure Examination
supervised by the Professional Regulation
Commission. The board is scheduled twice a
year (September and March).
• The composition of questions come from six
major subjects with their corresponding
relative weight. Clinical Chemistry,
Microbiology and Parasitology, Hematology,
Blood Banking and Serology each have 20%
while Clinical Microscopy (Urinalysis and
other body fluids) and Histopathologic
Technique each have 10%. To pass the
MedTech Licensure Examination, you need
to achieve a general weighted average of
75% with no rating below 60% in all the
subjects
WEEK 5: OVERVIEW OF MEDICAL TECHNOLOGY
MEDICAL TECHNOLOGY
• Also known as Clinical Laboratory Science or
Laboratory Medicine
• Refers to the application of diagnostic,
preventive, and therapeutic medicine to
monitor and improve the management of
health conditions.
Notable scientist have provided definitions of
Medical Technology:
❖ Anna Fagelson (1961)- defined it as the
branch of medicine concerned with the
performance of laboratory determinations
and analyses used in the diagnosis and
treatment determinations and analyses used
in the diagnosis and treatment of disease
and the maintenance of health.
❖ Walters (1996) defined it as the health
profession concerned with performing
laboratory analyses in view of obtaining
information necessary in the diagnosis and
treatment of diseases as well as in the
maintenance of good health.
❖ Ruth Heinemann (1963) defined it as the
principle of natural, physical, and biological
 sciences in laboratory procedures to aid in
the diagnosis and treatment of diseases.
RUTH WILLIAMS
• A Medical Technologist
• Believes that medical technology began from
the MEDIEVAL PERIOD (1096-1438) as
supported by the fact that urinalysis was a
fad.
• Early Hindu doctors made the “SCIENTIFIC
OBSERVATION” that the urine of certain
individuals attract ants, and that such urine
has a sweetish taste.
o QUACKS, calling themselves doctors
reaped fortunes from diagnosing
diseases by the appearance of the
urine
REPUBLIC ACT NO. 5527
• Also known as “The Philippine Medical
Technology Act of 1969”
• defined Medical Technology as an auxiliary
branch of laboratory medicine which deals
with the examination of tissue, secretion and
excretion of the human body and body fluids
by various electronic, chemical, microscopic
and other medical laboratory procedures or
techniques either manual or automated
which will aid the physician in the diagnosis
study and treatment of disease and in the
promotion of health in general.
CLINICAL LABORATORIES
• Facilities that perform chemical and
microscopic examinations of various body
fluids like blood, and tissues.
• A wide field where novelty plays a crucial role
on sustaining health.
• These laboratories are found in a variety of
settings, both in government and private
hospitals or free-standing (non-hospital)
laboratories such as those found clinics,
group practices, physician’s offices,
veterinary offices, government agencies and
military institution.
TYPES OF CLINICAL LABORATORIES:
• Small Size Hospital (<100 beds) – perform
only routine procedures
• Medium Size Hospital (100-300 beds) – has
a laboratory that can perform all routine tests
including more complicated procedures.
• Large-sized Hospital (over 300 beds) – can
handle large volumes of work and perform
complex tests.
PATHOLOGIST
• Director of a clinical laboratories.
• Licensed physician with a specialty in
Pathology as certified by the Philippine Board
of Pathology.
• Pathology is defined as the practice of
medicine which contributes to diagnosis,
prognosis and treatment through knowledge
gained by laboratory applications of the
biologic, chemical or physical science to man
or material obtained from the man.
AREAS OF PATHOLOGY:
• Anatomic Pathology - is the diagnosis of
confirmation of diseases through autopsy
examination and cellular differentiation of
autopsy and surgical tissue.
• Clinical Pathology - specialized in
chemical, microbiological and hematological
procedures.
MEDICAL TECHNOLOGIST
• Has a baccalaureate degree program from a
college or university recognized by the
Commission on Higher Education.
• Completed a specified clinical internship in a
training laboratory accredited by Bureau of
Heath Facilities and Services of the
Department of Health.
• Has passed the licensure examination
administered by the Board of Medical
Technology of the Professional Regulation
Commission.
• Work as medical detective using
microscopes to observe details in cells, ova
and cysts of parasitic organism.
• Measures substance in blood and other
fluids.
• Compatibility testing of donor-recipient.
• Identifying organism causing infection and
diseases.
• Uses of standards and control to improve the
reliability of laboratory result.
 • Work under pressure with speed, accuracy
and precisions.
HISTORY OF MEDICAL TECHNOLOGY
Ebers papyrus – the oldest preserved Egyptian
compilation of medical texts, it was written on 1500
BC. A book for treatment of diseases contains
description of the three stages of hookworm
infection.
o It contains chapters on contraception,
pregnancy eye and skin problems,
surgery, burns and intestinal disease
and parasites.
HIPPOCRATES – Ancient Greek Physician, “Father
of Medicine,” at around 300 B.C advocates the use
of “mind and senses” as diagnostic tools. He
described four humors or body fluids in the human
body, namely, the blood, phlegm, yellow bile and
black bile.
o Hippocrates associated the appearance
of bubbles on the surface of urine to
kidney disease and chronic illness.
Rufus of Ephesus (50 A.D) – made the first
description of hematuria. He also attributed
hematuria to the inability of the kidneys to filter
blood.
Vivian Herrick- Traces the beginning of medical
technology back to 1500 BC when intestinal
parasites such as TAENIA and ASCARIS were
mentioned in early writings.
Isaac Judaeus- a Jewish physician and
philosopher, in his book Kitab al Baul (Book of
Urine), he detailed the concepts of urine formation,
urinary sediments, and urine characteristics in
relation to disease.
o He also formulated rules for the use of
urine in patients diagnosis.
o He was considered One of the
Founder of the Origins of Nephrology.
Zacharias Janssen and his Father Hans- opened
the door to the world of the invisible in the 1590’s
wherein they invented microscope.
Athanasius Kircher- Jesuit Priest, one of the
earliest microscopists who observed that the blood
of patients with plagues contained “worms”.
Marcelo Malphigi- an Italian microscopist, was
regarded the founding Father of Modern Anatomic
pathology. Renowned for his exploration of
embryology of chick and histology and physiology of
the glands and viscera.
Antonie Van Leeuwenhoek (1632-1723)
• Invented and improved the compound
microscope
• The first to describe red blood cells, to see
protozoa, and to classify bacteria according
to shape.
• Invention of the microscope led to the rapid
progress of microbiology and pathology. He
became the “Father of Microbiology”
Frederick Dekkers - in 17th century, he observed
protein in the urine precipitated when boiled with
acetic acid. This finding is the indicator of
diagnosing proteinuria.
Richard Lower – Cornish Physician, investigated
and showed that it is possible to transfuse blood
from one animal to another.
William Hewson – in 18th century, an English
physiologist discovered that the blood specimen
collected was clotted, a plasma could be separated
from the blood cells. Also describe “coagulable
lypmph” known as fibrinogen.
Rudolph Virchow - One of the youngest medical
specialists
• Founded the ARCHIVES OF PATHOLOGY
in BERLIN in 1847
Hermann Fehling
• Performed the FIRST QUANTITATIVE TEST
in URINE SUGAR in 1848. MIDDLE OF 15th
CENTURY
• Aniline Dyes were used in staining
microorganisms Bacterial staining and
microscopic study on bacteria were made
possible.
 HISTORY OF MEDICAL TECHNOLOGY IN UNITED AMERICAN BOARD OF PATHOLOGY
STATES ESTABLISHED
• Late 19th Century the emergence of clinical
laboratories in United States occurred due to 1919 census
advances in medical science. 100 technicians, all male were employed in the
Dr. William H. Welch (1878) – established another UNITED STATES. •
laboratory at the Bellevue Hospital Medical College. • This increased to 3500 in 1920.
In 1885, Dr. welch became the first professor of
Pathology at John Hopkins University. In 1922,

Dr. William Osler (1896) – first clinical laboratory 3035 hospitals had CLINICAL
was opened at John Hopkins University. LABORATORIES

• In this laboratory, routine examinations were WORLD WAR II

carried out, special attention being given to
the search for malarial parasites in the blood.
• A clinical laboratory was also opened at the
UNIVERSITY OF PENNSYLVANIA in 1896
(WILLIAM PEPPER LABORATORY).
1908 DR. JAMES CAMPBELL TODD - wrote the
book: A MANUAL OF CLINICAL DIAGNOSIS
Retitled “CLINICAL DIAGNOSIS AND
MANAGEMENT BY LABORATORY METHODS” by
JOHN BERNARD HENRY
• In 1944, US bases were put in Leyte during
World War II in the Philippines. They brought
their Members of the US healthcare team.
• Marked effects in laboratory medicine
• The use of blood increased and the “closed
system” of blood collection was widely used.
• Instrumentation advanced and these
instruments paved the measurement of the
intensity of color produced.

• The book describes the techniques and • Automated equipment appeared and quality
procedures of the laboratory test available control programs became common.
then.
• The lab offered training programs to high
• in its 6th Edition by Dr. Todd and Dr. Arthur school graduates as early as
Sanford. - the book became the standard FEBRUARY,1944.
reference for laboratories.
• 26th Medical Infantry Division of the 6th US
In 1915, Pennsylvania State Legislature passed army introduces Medical Technology. The
a Law requiring all hospitals to be equipped with first Clinical Laboratory at 208 Quiricada St.,
adequate laboratory employing trained technicians. Sta. Cruz, Manila was built.

In 1923, The University of Minnesota was the o It is now known as the Manila Public
first to offer a degree program on medical Health Laboratory
technology. o Left on June 1945 and endorsed the
Laboratory to the National Department
A course bulletin titled: “COURSES IN MEDICAL of Health.
TECHNOLOGY FOR CLINICAL AND o The Department rendered the
LABORATORY TECHNICIANS” was issued in laboratory non- functional for
1922. sometime.

They were the FIRST to offer a DEGREE LEVEL Dr. Alfredo Pio de Roda- recognized the deserted
PROGRAM in 1923. laboratory on Oct 1, 1945.

1936
 • He was supported by Dr. Mariano
Icasiano who was the was then the
Manila City Health Officer.
• The laboratory later named Manila Public
Health Laboratory
• 1947 Training of high school graduates to
work as medical technicians
• No period of training was set and No
certificates were given. By: Dr. Pio De
Roda Dr. Prudencia Sta. Ana.
• 1954 A 6 months laboratory training with
certificate upon completion was given to
the trainees. Dr. Sta. Ana prepared the
syllabus for the training program.
• The First Four-year Bachelor of Science
in Medical Technology program was
offered by the Philippine Union College
(now Adventist University of the
Philippines) and the Manila Sanitarium
(now Manila Adventist Medical Center) in
1954.
MEDICAL TECHNOLOGY EDUCATION IN THE
PHILIPPINES
• Dr. Antonio Gabriel and Dr. Gustavo
Reyes of the FACULTY of Pharmacy,
University of Sto. Tomas offered medical
technology as an elective subject to 4th
and 5th year B.S. Pharmacy students.
• The Training program offered by Dr. Pio
De Roda did not last long.
• The FIRST B.S. Degree course in
Medical Technology was offered by the
PHILIPPINE UNION COLLEGE and
MANILA SANITARIUM.
• After 2 years, PUC produced its first
graduate, Dr. Jesse Umali, now a
successful OB- Gynecologist
• Rev., Fr. Lorenzo Rodriguez decided to
offer it as a course because of the
popularity of medical technology among
pharmacy students.
JUNE 17,1957
• Temporary permit was issued by the
Dept. of Education, for first to third year
students.
JUNE 1960
• The permit for the internship program was
issued.
JUNE 14,1961
• Full recognition of the 4-year B.S. Medical
technology course was given on June 14,
1961.
POST GRADUATE STUDIES •
• Offered to B.S. Medical Technology
graduates MS in Medical Technology
• UST Graduate School • Philippine Women’s
University
• Manila Central University MS in Public
Health (one-year, non-thesis degree)
• University of the Philippines Manila
• AUF, CEU and OLFU
 MLSP 111: MEDICAL LABORATORY SCIENCE PRACTICE 1

THE CLINICAL LABORATORY • Facilities

BASIC MANAGEMENT RESPONSIBILITIES • Personnel
OPERATION MANAGEMENT • Adequate financial resources
• Quality assurance • Test cost analysis
• Policy and procedures
• Strategic planning
• Benchmarking
• Productivity assessment CUSTOMER SEGMENTS/ SPECIFIC TARGETS
• Legislation / regulations • Health care providers
• Medico legal concerns • Hospital laboratories, Physician office
• Continuing education laboratories (POL)
• Staff meetings • Insurance company
• Colleges, Universities and other schools
HUMAN RESOURCE MANAGEMENT
• Nursing homes, Home Health Agencies,
• Job description
Clinics
• Recruitment and staffing
• Researchers, Clinical trials, Pharmaceutical
• Orientation
companies
• Competency assessment
• Unique socio economic and ethnics
• Personnel records
• Population shifts (rural, urban, suburban)
• Performance evaluation
• Discipline and dismissal PROCESSES AND MARKETING
• Develop a sales/marketing plan
FINANCIAL MANAGEMENT
o Develop brochures
• Departmental budgets o Specimen collection manuals
• Billing o Other customer related materials
• Test cost analysis o Website
• Fee schedule maintenance • Set goals
MARKETING MANAGEMENT • Ensure infrastructures is adequate
• Customer service • Support and maintain existing client services
• Outreach marketing • Place advertisements
• Advertising REQUIREMENTS AND PROCEDURES FOR
• Website development APPLICATION OF PERMIT TO CONSTRUCT AND
LICENSE TO OPERATE
• Client education
APPLICATION OF PERMIT TO CONSTRUCT
ISSUES TO CONSIDER WHEN ESTABLISHING A 1. Letter of application to the director of BHFS
LABORATORY: 2. Four (4) set of site development plans and
ENVIRONMENTAL ASSESSMENT floor plans approved by architect and or
• What are the customer needs? engineer
• Who is the competition? 3. SEC registration (for private laboratory) - if
• 4 P’s of Marketing partnership
o Product 4. if sole prop. DTI registration only
o Price
APPLICATION FOR NEW LICENSE
o Place
1. A duly notarized application form “Petition to
o Promotion
Establish, Operate and Maintain a Clinical
• Right testing menu
Laboratory” shall be filed by the owner or his
• Equipments duly authorized representative at the BHFS.
 PERMIT AND LICENSE FEES:
1. A non refundable license fee shall be
charged for application for permit to
construct to operate a government and
private clinical laboratory
2. A non refundable fee shall be charged for
application for renewal of license to
operate.
3. All fees shall follow the current
prescribed schedules of fees to the DOH.
LABORATORY PHYSICAL DESIGN
CONSIDERATION:
• Identify space for offices, personal
facilities, storage, and conference/library.
• Review all floor plans, elevations for
appropriate usage, ensure space and
functions are related.
• Fume hoods, biological safety cabinets
must be located away from high traffic
areas and doorways
• Ensure proper temperature
• Base cabinets for laboratory counters
• Noise control, install ceilings
• Eyewash unit must be within 100 feet of
work areas.
SUGGESTED STANDARD DIMENSIONS:
Laboratory counter width: 2 feet 6 inches
Lab. Counter to wall clearance: 4 feet
Lab. Counter to counter clearance: 7 feet
Desk Height: 30 inches
Keyboard drawer height: 25-27 inches
Human body standing: 4 square feet
Human body sitting: 6 square feet
Desk space: 3 square feet
CLASSIFICATION OF LABORATORIES
BY FUNCTION:
• Clinical pathology: includes Hematology,
Clinical Chemistry, Mycology, Microbiology,
Parasitology, Clinical microscopy,
Immunology and Serology,
Immunohematology, Endocrinology,
Toxicology and Therapeutic Drug
Monitoring.
• Anatomic Pathology: includes Surgical
Pathology, Immunohispathology, Cytology,
Autopsy and Forensic Pathology.
BY INSTITUTIONAL CHARACTER:
• Hospital-based laboratory – a laboratory
that operates within the hospital.
• Non-hospital based laboratory- operates
on its own.
BY SERVICE CAPABILITY
PRIMARY
• Routine hematology (Hematocrit,
Hemoglobin, WBC count, Differential Count,
and Qualitative Platelet Determination)
▪ Routine Urinalysis and Fecalysis
▪ Blood typing
SECONDARY
• All primary laboratory tests
• Routine Clinical Chemistry (Glucose, BUN,
BUA, Creatinine, Blood Total Cholesterol
Concentration)
• Crossmatching
TERTIARY
• All secondary laboratory testing
• Special Chemistry
• Special Hematology
• Immunology and Serology
• Microbiology
TECHNICAL STANDARDS AND MINIMUM
REQUIREMENTS:
STAFFING
1. The clinical laboratory must be managed by a
licensed physician certified by the Phil Board
of Pathologist.
2. A clinical laboratory shall have sufficient
number of registered medical technologist
proportional to the workload and shall be
available at all times during hours of
laboratory operation.
3. There shall be staff development and
appropriate continuing education program
available at all levels of organization to
upgrade knowledge attitudes and skills of
staffs.
PHYSICAL FACILITIES
1. The clinical laboratory shall be well-ventilated,
adequately lighted, cleaned and safe.
2. The working space shall be sufficient to
accommodate its activities and allow smooth
and coordinated work flow.
3. There shall be an adequate water supply • 2% glutaraldehyde
4. The working space for all categories of clinical • Hydrogen peroxide
laboratories shall have at least the ff. • 10% Formalin
measurements: • Detergent
• Primary – 10 sq. m • Phenols
• Secondary- 20 sq. m • Ultraviolet radiation, Ionizing radiation,
• Tertiary- 60 sq. m (inc. separate photo-oxidation
enclosed and adequately ventilated room
LABORATORY HAZARD PREVENTION
for Microbiology)
STRATEGIES
EQUIPMENT / INSTRUMENTS WORKING PLACE CONTROL
1. There shall be provisions for sufficient number • Hand washing every after patient contact
and types of appropriate equipment in order to • Cleaning surfaces with disinfectants
undertake all the activities and lab. • Avoiding unnecessary use of needles
Examinations. These equipment shall comply and sharps and not recapping
with safety requirements. • Proper waste disposal
2. For other laboratory examinations being • Immunization for hepatitis
performed, the appropriate equipment • No eating, drinking and smoking inside
necessary for performing such procedures the laboratory
shall be made available • Warning signs

MINIMUM REQUIREMENTS FOR EQUIPMENT / ENGINEERING CONTROLS

INSTRUMENTS • Puncture proof containers
1. Primary Category – clinical centrifuge, • Safety needles that retracts after
microhematocrit centrifuge, microscope with extraction
oil immersion objective, hemoglobinometer or • Biohazard bags
its equivalent, differential blood cell counter. • Splash guards
2. Secondary Category- All primary category, • Volatile liquid carriers
refrigerator, Photometer, Water bath, Timer. • Sensor/ foot controlled sinks
3. Tertiary Category- All secondary category, • Biological safety cabinets and fume hoods
incubator, Balance, rotator, Serofuge,
PERSONAL PROTECTIVE EQUIPMENT (PPE)
Autoclave, Drying oven, Biosafety cabinet or
• Nonlatex gloves
its equivalent.
• Gowns and laboratory coats
GLASSWARES / REAGENT / SUPPLIES • Mask inc. particle respirators
• All categories of clinical laboratories shall • Faceshields
provide adequate and appropriate • Protective eyewears (goggles)
glasswares, reagents and supplies • Eyewash stations
necessary to undertake the required • Chemical resistant gloves
services.
QUALITY CONTROL PROGRAM
WASTE MANAGEMENT INTERNAL QUALITY CONTROL PROGRAM
• There shall be provisions for adequate and 1. There shall be a documented continuous
efficient disposal of waste following competency assessment program for all
guidelines of the Department of Health and laboratory personnel.
the local government. 2. The program shall provide appropriate
and standard laboratory methods
SAFETY reagents supplies and equipment.
COMMON DECONTAMINATION AGENTS 3. There shall be program for proper
• Heat maintenance of all equipment.
• Ethylene oxide
 4. The program shall provide QC reference
materials.
EXTERNAL QC PROGRAM
1. All clinical laboratories shall participate in
External Quality Assurance Program given
by designated National Reference
Laboratories or other Recognized Reference
Laboratories.
2. A satifactory performance rating given by a
National Reference Labs shall be one of the
criteria for the renewal of license.
3. Any refusal to participate in EQAP given by
the NRL shall be one of the basis for
suspension revocation of the license of the
Three major areas of study within ethics recognized
laboratory
today are:
IMPLEMENTING RULES AND REGULATIONS
(IRR) OF THE REPUBLIC ACT NP. 10912, known
as the “CONTINUING PREFESSIONAL
DEVELOOPMENT (CPD) ACT OF 2016.
FELICIANO BELMONTE
1. What is Republic Act No. 10912 all about?
Republic Act No. 10912, otherwise known as the
“Continuing Professional Development (CPD) Act of
2016”, is an act which requires CPD as the
mandatory requirement for the renewal of
Professional Identification Card of all registered and
licensed professionals under the regulation of the
PRC.
2. When was the Law enacted and what is its
date of effectivity?
The CPD Act lapsed into Law on July 21, 2016 and
it took effect on August 16, 2016.
3. When is the implementation of R.A. No.
10912?
The implementation of R.A. No. 10912 started on
March 15, 2017, upon the effectivity of Resolution
No. 1032 or the Implementing Rules and
Regulations (IRR) of R.A. No. 10912.
ETHICS
• Ethics or moral philosophy is a branch
of philosophy that involves systematizing,
defending, and recommending concepts of
right and wrong conduct.[1] The
term ethics derives from Ancient
Greek ἠθικός (ethikos), from ἦθος (ethos),
meaning 'habit, custom'. The field of ethics,
along with aesthetics concern matters
of value, and thus comprise the branch of
philosophy called axiology.[2]
• Ethics seeks to resolve questions of human
morality by defining concepts such as good
and evil, right
and wrong, virtue and vice, justice and crime.
As a field of intellectual enquiry,
moral philosophy also is related to the fields
of moral psychology, descriptive ethics,
and value theory.
• Meta-ethics, concerning the theoretical
meaning and reference of moral propositions,
and how their truth values (if any) can be
determined
• Normative ethics, concerning the practical
means of determining a moral course of action
• Applied ethics, concerning what a person is
obligated (or permitted) to do in a specific
situation or a particular domain of action
• Professional ethics encompass the personal,
and corporate standards of behavior expected
by professionals
PROFESSIONAL ETHICS
• The word professionalism originally applied to
vows of a religious order. By at least the year
1675, the term had seen secular application
and was applied to the three learned
professions: Divinity, Law, and Medicine. The
term professionalism was also used for the
military profession around this same time.
• Professionals and those working in
acknowledged professions exercise specialist
knowledge and skill. How the use of this
knowledge should be governed when
providing a service to the public can be
considered a moral issue and is termed
professional ethics.
1. To define professional privileges,
behaviors and responsibilities towards
the members of the community in
general
 2. To promote professional quality,  Report any violations of the above principles
professional conduct and a moral of the professional conduct to authorized
method of procedures agency and to the ethics committee of the
3. To defend private professions from organization
undue interference by the government
To those principles, I hereby subscribe and
or by other private agencies
pledge to conduct myself at all times in a manner
4. To preserve the dignity of the profession
befitting the dignity of my profession
and the confidence of the public
Revised Code of Ethics – March, 7,1997
5. To defend clients from unscrupulous
professional PAMET Office
6. To fix certain standards of the
compensations for services or work

MEDTECH’S CODE OF ETHICS

As I enter into the practice of Medical Technology, I
shall:

 Accept the responsibilities inherent to being

a professional

 Uphold the law and shall not participate in

illegal work

 Act in a spirit of fairness to all and in a spirit

of brotherhood toward other members of the
profession

 Accept employment from more than one

employer only when there is no conflict of
interest

 Perform my task with full confidence,

absolute realibility and accuracy

 Share my knowledge and expertise with my

collegues

 Contribute to the advancement of the

professional organization and other allied
health organizations

 Restrict my praises, criticisms, views and

opinions within constructive limits

 Treat any information I acquired in the course

of my work as strictly confidential

 Uphold the dignity and respect of my

profession and conduct myself a reputation
of realibility, honesty and integrity

 Be dedicated to the use of clinical laboratory

science to promote life and benefit mankind
 WEEK 11: INTRODUCTION • The science of investigating small objects
using such an instrument is
called microscopy.

RISK MANAGEMENT AND LABORATORY SAFETY

• Risk Management – ensures health safety
of personnel as well as environment safety.
o Standard operating Procedure –
detailed step by step procedures of all
operations in each section of the
laboratory.
▪ Instrumentation
▪ Quality Assurance
▪ Safety in the Laboratory
▪ Hazards
▪ First aid
▪ Procedures
RISK MANAGEMENT AND LABORATORY SAFETY -
INSTRUMENTATION
• Instrumentation – Care appropriate use
and maintenance of equipment.
• Equipment record
o Name, Manufacturer, Model, Serial #
o Preventive maintenance record
o Operating manual
• Do’s And Don'ts's
o READ the manual first!!
o Checklist – step by step approach in
assembling and troubleshoot
o Care and use
MICROSCOPE -an optical instrument used for
viewing very small objects that are not visible to the
naked eye.
RISK MANAGEMENT AND LABORATORY SAFETY
INSTRUMENTATION
PARTS OF MICROSCOPE
• MECHANICAL SYSTEM– Base, Arm, Stage,
Substage, Mechanical Stage
• LENS SYSTEM – Nosepiece, Objectives,
Eyepiece, Focal Length
• OTHER parts - On/OFF switch, Fine/course
adjustment Knob, Iris Diaphragm, condenser,
Light source
MICROSCOPE
EYEPIECE / OCULAR
• 10x magnification – magnifies the diameter
of the image 10 x.
• Interpupillary control – adjust lateral
separation of the eyepiece for the user to be
able to focus both eyes
OBJECTIVE LENSE (3)
• 10x –Low power
• 40x- high power
• 100x –oil immersion
• 50x - low oil immersion
OPTICAL TUBE LENGTH
• Distance between the eye piece and
objective. 160mm
• Directs the beam of light from the source onto
the specimen.
 IRIS DIAPHRAGM RISK MANAGEMENT AND LABORATORY SAFETY -
• Regulates the light that illuminates the slide. INSTRUMENTATION
• Source of light CARE AND USE OF MICROSCOPE
• Neck/Arm site for attachment for nosepiece • Dust Microscope and the outer surface of
• Revolving nosepiece lenses objectives with lens paper or Air bulb
• Focus control must be used when lens paper is not
o Fine and coarse adjustments available
• Eyepiece should be polished to remove dust
STAGE
and finger marks and should be checked for
• Contains movable assemble to facilitate the
critical illumination
study of the different parts of the slide.
• Check for dust on the rotating nosepiece and
• Stage control if dust is present should be dismantled and
• Condenser both lenses be cleaned
• Condenser should also be aligned and
checked for dust particles
• Microscope should be covered when not in
use
• Always support the microscope when
carrying. It should be cradled on hand
holding it by the arm, the other supporting the
base.

MICRSCOPE
IMPORTANT POINTS: NEEDS SCHEDULED QC &
PREVENTIVE MAINTENANCE:
1. Use oil in oil immersion objectives only
2. Use lens paper in cleaning the lenses
3. If a solvent is needed to clean the lenses,
remove the objectives from the microscope
first then proceed with the cleaning agent
which is usually xylene.
4. Always hold the microscope with 2 arms, do
not leave the microscope on the edge of the
table.
5. Turn off the microscope when not in use and
cover with protective plastic jacket or put in
the designated wooden box

MAINTENANCE OF A MICROSCOPE
• Performance verification
▪ Light and specimen visualization
alignment
• Function verification
• Condenser and diaphragm alignment
• Optical system – damage and dirt
• Coarse and fine adjustments
 MICROSCOPE
• Virtual image – image seen by the eye
through a compound microscope and is
upside down and reversed.
• Total magnification – is equal to the
magnification of the eye piece times the
magnification of the objectives.
• Numerical aperture – is the amount of light
entering the objective from the microscopic
field
• Refractive index – speed with which lights
travels in air divided by the speed with which
light travels through the substance
• Resolving power – ability of the
microscope at a magnification to distinguish
2 separate objects situated close to each
other.
• Depth of field – capacity of the objective
lens to focus in different planes at the same
time
• Chromatic aberrations –different focus
brought about by different capacity of the
wavelengths to be bent when passing
through the lens.
• Oil Immersion Microscopy
o Focus under LPO
o Switch to oil immersion objective
FLUORECENCE MICROSCOPY
o Adjust fine focus
o Examine specimen • tissue sections are irradiated with ultraviolet
UV light and the emission is in the visible
RISK MANAGEMENT AND LABORATORY SAFETY - portion of the spectrum. The fluorescent
INSTRUMENTATION substances appear brilliant on a dark
COMPOUND LIGHT MICROSCOPE background.
▪ 2 sets of lenses one magnifying the image • Thus, the microscope has a strong UV light
then the other finally enlarging the image source and special filters that select rays of
further in an image appearing inverted and different wavelengths by the substances.
laterally reversed • A fluorescence microscope is an optical
ELECTRON MICROSCOPE microscope that uses fluorescence and
▪ a type of microscope that uses a beam phosphorescence instead of, or in addition to,
of electrons to create an image of the reflection and absorption to study properties of
specimen. It is capable of much higher organic or inorganic substances
magnifications and has a greater resolving
power than a light microscope, allowing it
to see much smaller objects in finer detail.
 • A scanning electron microscope (SEM) is a
type of electron microscope that produces
images of a sample by scanning it with a
focused beam of electrons.

• Optimum contrast and resolution to

maximize specimen details with precise
focusing of light path

• Transmission electron microscopy (TEM) is a

microscopy technique in which a beam
of electrons is transmitted through an ultra-
thin specimen, interacting with the specimen as
it passes through
 • Flammable – substance that ignite at
temperature below flash point
• Explosive – chemicals that may explode
when aging
• Oxidizers – harmless by themselves but
may initiate or promote combustion when
contact w/ certain substance

PERMISSIBLE EXPOSURE LIMIT (PELS)

• Threshold limit values
• Occupational Exposure Limits
o Maximum allowable airborne
concentration of chemical (vapour,
fume, Dust) to which a worker may be
exposed
QUALITY ASSURANCE
LABELLING – MSDS
• Personnel
MATERIAL SAFETY DATA SHEET
• Reagents
• Chemical Name; ingredients
STANDARD OPERATING PROCEDURE • Manufacturers’ name, address,
• Laboratory safety and personal hygiene • Date of purchase
• Handling of hazardous substances • Expiry date
• Records of regulatory compliances • Hazard warning and safety procedure
• Risk assessment
STORAGE OF HAZARDOUS CHEMICALS
• PPE
• Conventional cabinets
HEALTH HAZARD • Below countertops
• Biohazards –refers to anything that can • Plastic or plastic covered containers
cause disease in human, • Shelves with labels
• Irritants - reversible inflammatory effects
HANDLING OF SPILLS
• Corrosive – destruction or irreversible
• PPE
alteration
• Cleanup aids
• Sensitizers – allergic reactions
• Bleach/ baking soda/ vinegar/
• Carcinogens – induces tumor
• Buckets
• Toxic materials – capable of causing death
• Sponge/towel/rag
PHYSICAL HAZARD
• Combustible – substance that ignite at a FIRST AID
certain temperature or flashpoint
 MODES OF TRANSMISSION
An infectious agent may be transmitted
from its natural reservoir to a susceptible host in
different ways. There are different classifications for
modes of transmission. Here is one classification:
• Direct
• Direct contact
• Droplet spread
• Indirect
• Airborne
• Vehicleborne
• Vectorborne (mechanical or biologic)
In direct transmission, an infectious agent is
transferred from a reservoir to a susceptible host by
direct contact or droplet spread.
Direct contact occurs through skin-to-skin
contact, kissing, and sexual intercourse. Direct
contact also refers to contact with soil or vegetation
harboring infectious organisms. Thus, infectious
mononucleosis (“kissing disease”) and gonorrhea
are spread from person to person by direct contact.
Hookworm is spread by direct contact with
contaminated soil.
Droplet spread refers to spray with relatively
large, short-range aerosols produced by sneezing,
coughing, or even talking. Droplet spread is
classified as direct because transmission is by direct
spray over a few feet, before the droplets fall to the
ground. Pertussis and meningococcal infection are
examples of diseases transmitted from an infectious
patient to a susceptible host by droplet spread.
Indirect transmission refers to the transfer of
an infectious agent from a reservoir to a host by
suspended air particles, inanimate objects
(vehicles), or animate intermediaries (vectors).
Airborne transmission occurs when infectious
agents are carried by dust or droplet nuclei
suspended in air. Airborne dust includes material
that has settled on surfaces and become
resuspended by air currents as well as infectious
particles blown from the soil by the wind. Droplet
nuclei are dried residue of less than 5 microns in
size. In contrast to droplets that fall to the ground
within a few feet, droplet nuclei may remain
suspended in the air for long periods of time and may
be blown over great distances. Measles, for
example, has occurred in children who came into a
physician’s office after a child with measles had left,
because the measles virus remained suspended in
the air
Vehicles that may indirectly transmit an
infectious agent include food, water, biologic
products (blood), and fomites (inanimate objects
such as handkerchiefs, bedding, or surgical
scalpels). A vehicle may passively carry a pathogen
— as food or water may carry hepatitis A virus.
Alternatively, the vehicle may provide an
environment in which the agent grows, multiplies, or
produces toxin — as improperly canned foods
provide an environment that supports production of
botulinum toxin by Clostridium botulinum.
Vectors such as mosquitoes, fleas, and ticks
may carry an infectious agent through purely
mechanical means or may support growth or
changes in the agent. Examples of mechanical
transmission are flies carrying Shigella on their
appendages and fleas carrying Yersinia pestis, the
causative agent of plague, in their gut. In contrast, in
biologic transmission, the causative agent of malaria
or guinea worm disease undergoes maturation in an
intermediate host before it can be transmitted to
humans.
EPIDEMIOLOGIC METHODS
TRANSMISSION
• An organism must be transmitted, either
directly or indirectly, from one place to
another.
1. DIRECT TRANSMISSION
• Occurs when a reservoir and the susceptible
host are in close proximity, closer than 6 feet.
• Direct Contact Transmission occurs from
skin-to-skin contact, as with sexually
transmitted disease or direct contact with a
free-living organism in the environment.
• Droplet Spread occurs when infectious
aerosols produced by coughing, talking, and
sneezing transmit infection to susceptible
host.
• These infectious aerosols are large particles
that are pulled to the ground by gravity and
can only infect a new host within a distance
of 6 feet.
 2. INDIRECT TRANSMISSION
• Occurs when the reservoir and the
susceptible host are separated.
• This separation can be as small as 6 feet or
as large as thousand miles.
• Vector spread involves the transmission of
an infectious agent from an animate
organism, such as mosquitoes, fleas, mites,
and ticks.
• Infectious agents may be transmitted
through purely mechanical means, such as
on the feet or the wings of the insect or it may
actually grow and multiply in the vector.
• Vehicle spread involves the transportation of
an infectious agent or inanimate objects such
as toys, school supplies, bedding, or biologic
equipment, or in contaminated food, water,
milk or biological supplies.
• Airborne spread involves droplet nuclei 1-5
microns in size, which are produced by
talking, sneezing, coughing or singing and
float on air currents over large distances for
varying periods of time.
The three major epidemiologic techniques are
• descriptive,
• analytic and
• experimental.
A. DESCRIPTIVE EPIDEMIOLOGY
• The data that describe the occurrence of
disease are collected by various methods
from all relevant sources.
• The data are then collated by time, place and
person.
Four trends are considered in describing the
epidemiologic data:
1. Secular trend- describes the occurrence of
disease over a prolonged period.
• it is influenced by the degree of immunity
of the population and possibly
nonspecific measures are improved as
socioeconomic and nutritional levels
among population. AKA long time trend
2. Periodic trend- a temporary modification in
the overall secular trend. It may indicate a
change in the antigenic properties of the
causative agent.
• A lowering of the overall immunity of a
population or a segment thereof can
result to an increase in the occurrence
of the disease.
• Seasonal trend- reflects the seasonal
changes in disease occurrence
following changes in environmental
conditions that enhance the ability of the
agent to replicate or be transmitted.
• Epidemic occurrence- an epidemic is
a sudden increase in occurrence due to
prevalent factors that support
transmission.
Three different sites considered in the description of
epidemiologic data by place:
• Where the individual was when the disease
occurred
• Where the individual was when he or she
became infected from the source
• Where the source became infected with the
etiologic agent.
• The third focus of descriptive epidemiology is
the infected person.
• All pertinent characteristics should be noted:
age, sex, occupation, personal habits,
socioecnomic status, immunization history,
presence of underlying disease, and other
data.
B. ANALYTIC EPIDEMIOLOGY
• analyzes disease determinants for possible
causal relationships.
• The two main analytic methods are the case-
control (case-comparison) and the cohort
method.
CASE CONTROL METHOD
• starts with the effect and retrospectively
investigates the cause of disease.
• Relatively easy to conduct and can be
completed in a shorter period
• Inexpensive and reproducible
COHORT METHOD
• prospectively studies two populations: one
that has had contact with the suspected
 causal factor under study and a similar group
that has had no contact with the factor.
• Advantages include accuracy of the
collected data and the ability to make a direct
estimate of the disease risk resulting from
factor contact
• More expensive
CROSS-SECTIONAL STUDY
• a population is surveyed over a limited period
to determine the relationship between a
disease and variables present at the same
time that may influence its occurrence.
C. EXPERIMENTAL EPIDEMIOLOGY
• a hypothesis is developed and an
experimental model is constructed in which
one or more factors may be manipulated.
• Manipulation will either confirm or disprove
the hypothesis.
EPIDEMIC INVESTIGATION
• Describes the factors relevant to an outbreak
of disease.
• Data are collected, collated according to
time, place and person, and analyzed and
inferences are drawn.
BIOSAFETY & BIOSECURITY
Biosafety describes the containment principles,
technologies and practices that are implemented to
prevent the unintentional exposure to Biological
agents and toxins or their accidental release
WHAT IS BIOSAFETY?
• Biosafety is defined as, “The discipline
addressing the safe handling and
containment of infectious microorganisms
and hazardous biological materials” (1). The
practice of safe handling of pathogenic
micro-organisms and their toxins in the
biological laboratory is accomplished
through the application of containment
principles and the risk assessment.
BIOSECURITY
Describes protection, control and accountability for
valuable biological materials within laboratories, in
order to prevent their loss, theft, misuse, diversion
of, unauthorized access or intentional release
whether or not the biorisk(s) is acceptable
WHAT IS A BIOHAZARD?
A biohazard, also known as a biological hazard, is a
biological substance that poses a threat to human
and animal health.
Examples of biohazards include:
• Human or animal blood
• Human or animal waste and body fluids
• Deceased animals
• Human remains
• Used drug needles
• Medical waste (used syringes and
bandages)
• Rotting food
• All of these substances can harbor bacteria
(like E. Coli) and viruses (like Hepatitis and
HIV) that can cause disease in humans and
animals.
Biohazards may enter the body and cause
damage if they are inhaled through
breathing, ingested through swallowing, or
absorbed through breaks in the skin.
 SYMBOL
Biological hazards, also
known as biohazards,
refer to biological
substances that pose a
threat to the health of
living organisms, primarily
that of humans.
The biohazard symbol was developed in 1966
by Charles Baldwin, an environmental-health
engineer working for the Dow Chemical Company
on the containment products
It is used in the labeling of biological
materials that carry a significant health risk,
including viral samples and used hypodermic
needles. In unicode, the biohazard symbol is
U+2623
CRITERIA IN THE SYMBOL FORMATION
• Striking in form in order to draw immediate
attention;
• Unique and unambiguous, in order not to be
confused with symbols used for other
purposes;
• Quickly recognizable and easily recalled;
• Symmetrical, in order to appear identical from
all angles of approach;
• Acceptable to groups of varying ethnic
backgrounds.
• There are four circles within the symbol,
signifying the chain of infection.
• Agent: The type of microorganism, that
causes infection or hazardous condition.
• Host: The organism in which the
microorganism Infect. The new host must be
susceptible.
• Source: The host from which the
microorganism originate. The carrier host
might not show symptoms.
• Transmission: The means of transmission,
mostly direct or indirect. Some routes of
transmission include air, insect, direct contact
and contaminated surfaces.
CLASSIFICATION
Bio hazardous agents are classified for
transportation by UN Number:
Category A, UN 2814 – Infectious substance,
affecting humans: An infectious substance in a form
capable of causing permanent disability or life-
threatening or fatal disease in otherwise healthy
humans or animals when exposure to it occurs.
Category A, UN 2900 – Infectious substance,
affecting animals (only): An infectious substance
that is not in a form generally capable of causing
permanent disability or life-threatening or fatal
disease in otherwise healthy humans and animals
when exposure to themselves occurs.
Category B, UN 3373 – Biological substance
transported for diagnostic or investigative purposes.
Regulated Medical Waste, UN 3291 – Waste or
reusable material derived from medical treatment of
an animal or human, or from biomedical research,
which includes the production and testing.
LEVELS OF BIOHAZARD
Biohazard Level 1
Bacteria and viruses including Bacillus
subtilis, canine hepatitis, Escherichia
coli, varicella (chicken pox), as well as some cell
cultures and non-infectious bacteria. At this level
precautions against the biohazardous materials in
question are minimal, most likely involving gloves
and some sort of facial protection
Biohazard Level 2
Bacteria and viruses that cause only mild
disease to humans, or are difficult to contract
via aerosol in a lab setting, such as hepatitis A, B,
and C, some influenza A strains, Lyme
disease, salmonella, mumps, measles, scrapie,
dengue fever, HIV. Routine diagnostic work with
clinical specimens can be done safely at Biosafety
Level 2, using Biosafety Level 2 practices and
procedures. Research work (including co-cultivation,
virus replication studies, or manipulations involving
concentrated virus) can be done in a BSL-2
(P2) facility, using BSL-3 practices and procedures.
Biohazard Level 3
Bacteria and viruses that can cause severe
to fatal disease in humans, but for which vaccines or
other treatments exist, such as anthrax, West Nile
virus, Venezuelan equine encephalitis, SARS
virus, MERS
coronavirus, hantaviruses, tuberculosis, typhus
, Rift Valley fever, Rocky Mountain spotted
fever, yellow fever, and malaria.
Biohazard Level 4
Viruses that cause severe to fatal disease in
humans, and for which vaccines or other treatments
are not available, such as Bolivian hemorrhagic
fever, Marburg virus, Ebola virus, Lassa fever
virus, Crimean–Congo hemorrhagic fever, and
other hemorrhagicdiseases and
rishibola. Variola virus (smallpox) is an agent that
is worked with at BSL-4 despite the existence of a
vaccine, as it has been eradicated. When dealing
with biological hazards at this level the use of
a positive pressure personnel suit, with a
segregated air supply, is mandatory. The entrance
and exit of a Level Four biolab will contain multiple
showers, a vacuum room, an ultraviolet light
room, autonomous detection system, and other
safety precautions designed to destroy all traces of
the biohazard. Multiple airlocks are employed and
are electronically secured to prevent both doors
opening at the same time. All air and water service
going to and coming from a Biosafety Level 4 (P4)
lab will undergo similar decontamination procedures
to eliminate the possibility of an accidental release.
Currently there are no bacteria classified at this
level.
BRIEF HISTORY OF BIOSAFETY
• In the mid- to late 1800’s, the science of
microbiology had advanced to the point that
the causative bacterial agent of common
diseases such as tuberculosis, diphtheria
and cholera were identified using Koch’s
postulates.
• Following close behind this initial work in the
culture and purification of bacterial
pathogens, LAIs were first reported. In the
early- to mid-1900’s, wooden and steel
boxes were designed to prevent work-related
LAIs, however it took many more years for
the discipline of biosafety to
develop. Biological Safety was pioneered at
the U. S. Army Biological Research
Laboratories in Fort Detrick Maryland led by
the efforts of Arnold G. Wedum, Director of
Industrial Health and Safety and the father of
modern biological safety. Dr. Wedum was
one of the original pioneers of the first
Biological Safety Conference and was
central in the formation of the American
Biological Safety Association (ABSA).
• April 18, 1955-first unofficial meeting at
Camp Detrick (now Fort Detrick) and
involved members of the military
representing Camp Detrick, Pine Bluff
Arsenal, Arkansas (PBA), and Dugway
Proving Grounds, Utah (DPG).
• In those days, the offensive BW program of
the United States was in full swing: the
opening keynote address was “The Role of
Safety in the Biological Warfare Effort.”
• Beginning in 1957, the yearly meetings
began to include non-classified sessions to
broaden the reach of the Association;
representatives of the USDA were regular
attendees through this “transition period.”
• There were striking changes in the meetings
in 1964-1965: the NIH and CDC joined for
the first time, along with a number of other
relevant federal agencies
• All classified information was removed
accompanied by a concerted effort to
declassify safety studies and release them
for public knowledge and advantage.
• By 1966, the attendees included universities,
private laboratories, hospitals, and industry.
Gradually, federal regulations began to
appear.
• In 1973, the impact of new OSHA regulations
was analyzed and debated at the ASBA
meeting; interestingly, there was a range of
responses to the new regulations:
• In 1974, the United States Postal Service
and Department of Transportation
introduced regulations for shipping of
etiologic agents (microorganisms and toxins
that cause disease in humans)
• New safety programs and trainings were
introduced.
• The designation of 4 levels of biosafety
originated in the mid-1970s,6 and the safety
requirements for research with recombinant
• DNA were hotly debated. A survey of the also exposed to anthrax. Thanks to intensive
ABSA meetings in the 1980s reveals therapy with antibiotics, his life was saved
increased focus on individual agents or • The commission who conducted the
groups of agents and coordination of investigation of the anthrax outbreak
international safety issues.7 ABSA now confirmed ten cases of the lung form of the
represents biosafety professionals in 20 illness and twelve cases of the skin form of
countries, and reflects the organic nature of anthrax. In the group with the lung form
the topic: biosafety is a fast-moving field with contamination, seven postal workers were
constant research into and reevaluation of its exposed to the inhalation of contaminants in
tenets as threat perception change and the process of working with contaminated
technologies advance mail as well as two press workers who also
participated in mail handling of
THE ANTHRAX ATTACKS correspondence that contained anthrax
• Anthrax is a disease caused by Bacillus spores. The outbreak seized Florida, New
anthracis, a germ that lives in soil. Many York, Nevada, and the District of Columbia.
people know about it from the
2001 bioterror attacks. In the attacks,
someone purposely spread anthrax through
the U.S. mail. This killed five people and
made 22 sick.
• The first documented incident of illness
associated with the circulation of anthrax
ORGANIZATIONS
was registered on October 2, 2001 in Florida.
• Bio Risk Association of Philippines (BRAP)
• Photo-publisher Robert Stevens, age 63,
• World Health Organization
was hospitalized with the diagnosis of
• American Biological Safety Association
meningitis and subsequently died on
(ABSA)
October 5, 2001.
• Center for Disease Control (CDC)
• The autopsy showed that the death was
• National Institute of Health (NIH)
caused by symptoms that had the
• Occupational Safety and Health
characteristics of an anthrax infection,
Administration (OSHA)
confirming a bacteriological inoculation.
• International Federation of Biosafety
Stevens reported the first signs of illness
Associations (IFBA
arose on September 27, 2001 during a
business trip in North Carolina. Researchers PRINCIPLES OF BIOSAFETY
established that his death was the first To protect:
incident with the lung form of anthrax in the
USA since 1976 • the patient
• The second incident of anthrax exposure • yourself
was registered by postal worker Ernesto • the environment
Blanko, 73, who was working with Stevens in
AIR TRANSPORT OF INFECTIOUS SUBSTANCES
the same building belonging to the company
International Air Transportation Association
American Media. Blanko’s illness symptoms
(IATA) Infectious Substances Shipping Guidelines
appeared on September 28, but he did not
seek medical assistance until October 1 with
suspicion of pneumonia. After the death of
Stevens, doctors began to pay more
attention to bacteriological analyses, and it
was eventually determined that Blanko was
 • WHO Collaborating Centre
laboratory, polio network laboratory
• Pasteur Institute network laboratory,
CDC/Namru/others

WHAT TO INCLUDE ON A REQUEST FORM

• Specimen collection date, time
• Epidemiological or demographic
identification
o to link laboratory and epidemiological
TRANSPORT OF INFECTIOUS SUBSTANCES data
Scientific background to the 13th revised edition of o patient’s name (or identifier/outbreak
the UN Model Regulations regarding the code), age, sex
requirements for transporting infectious substances
• Suspected clinical diagnosis, main clinical
TRANSPORT REGULATIONS (1) signs
Transport of infectious substances is subject to strict
national and international regulations: • Context

• proper use of packaging materials o suspected outbreak, confirmed

• proper labelling, notification outbreak, verified outbreak, end of
• Compliance: outbreak or routine surveillance
• reduces likelihood of damaging packages
• minimizes exposure • Sender name(s) and contact information
• improves carrier’s efficiency and confidence
MAIN GOALS
in package delivery
• protects the environment,
TRANSPORT REGULATIONS (2) • the carrier
Subject to regular amendments shippers refer to • protects the sample
latest issuances of national and international
Triple packaging
regulations for regulations
▪ arrival in good condition for analysis
International regulations not intended to supersede
local or national requirements where national • If triple packaging not available
requirements do not exist, international regulations o prepare according to international
should be followed dangerous goods transportation rules
(see IATA guidelines)
HOW TO SELECT A LABORATORY
• Depends on specimen and analyses
required THE BASIC TRIPLE PACKAGING SYSTEM
• assess lab’s capacity before sending • Three layers of protection are needed:
• Some analyses (e.g. Ebola) • primary receptacle
performed in few places • secondary packaging
• identify recipient before sending • outer packaging
• Depends on transportation options, timing • IATA shipping guidelines provide details
• Depends on what capacity available about definitions, packaging requirements,
markings and labels, accompanying
• national reference laboratory, documentation, notification protocols and
hospital laboratory refrigerants
The basic triple packaging system: • Infectious substances, Category A
primary receptacle o IATA Packing Instruction 602,
“Infectious substances”
• Leak-proof specimen container (UN 2814 or UN 2900)
• Packaged with sufficient absorbent o Use biohazard label
material to absorb the entire content of
the primary receptacle in case of
breakage

The basic triple packaging system:

secondary receptacle

• Leak-proof secondary container

• Encloses and protects the primary
receptacle(s)
o several cushioned primary
receptacles may be placed in one
secondary packaging
o sufficient additional absorbent
material to absorb all fluid in case of
breakage

The basic triple packaging system: Category B, “650 package” UN 3373

outer packaging No biohazard label

• Secondary packaging(s) are placed in

outer shipping packaging with suitable
cushioning material
• Outer packaging protects contents from
outside influences, physical damage,
while in transit
• Smallest overall external dimension 10
x10 cm

Infectious substances substances

included in the category A

• Highly pathogenic micro-organisms Category A “602 package”

• Indicative list available
o Haemorrhagic fever agents Labels: UN 2814 UN 2900 Biohazard
o Variola virus
TRIPLE PACKAGES
o Other pathogens dangerous only in
• Category B infectious substances may be
culture
shipped in "602" packages, as long as the
(of concern to laboratory staff only)
correct marking and labelling is provided on
KEY PRINCIPLES: DANGEROUS GOODS the outer package
• Infectious substances, Category B • Category A infectious substances cannot be
o IATA Packing Instruction 650, shipped in "650" packages
“Diagnostic specimens”
BIOSAFETY CONTAINMENT LEVELS
(UN 3373)
• Biosafety levels
o Use UN 3373 label
o Level 1& 2: basic laboratories
o Do not use biohazard label
 o Level 3: containment laboratories
o Level 4: high containment
laboratories
• Each level associated with appropriate
o Equipment, practices, work
procedures RELATION TO RISK GROUPS TO BIOSAFETY
• Diagnostic and health-care laboratories must LEVELS, PRACTICES AND EQUIPMENT
be biosafety level 2 or above BSL Laboratory Laboratory Safety
type practices equipment
RISK GROUP CLASSIFICATION
Risk Group Individual risk Community risk 1 Basic Good None
teaching, microbiologi
research cal Open
1 no, low no, low
techniques bench work

2 moderate low 2 Primary Good Open

health microbiologi bench
3 high low cal PLUS
services; techniques,
diagnostic biological
4 high high
protective safety
services, clothing, cabinet for
research potential
biohazard aerosols
Risk Group 1 sign
• Unlikely to cause animal or human 3 Special As BSL 2 Biological
disease diagnostic PLUS safety
• Non pathogenic agent cabinet
services, special and/or
Risk Group 2 research clothing, other
• Pathogenic for humans Containment controlled primary
• Unlikely a serious hazard access,
devices for
• Treatment and preventive measures all activities
available directional
• Limited risk of spread of infection airflow

Risk Group 3 4 Dangerous As BSL 3 Class III

PLUS biological
• Pathogenic, cause serious disease pathogen safety
• Effective treatment and preventive units airlock cabinet,
measures usually available entry,
Maximum positive
• Little person-to-person spread shower exit, pressure
special suits,
Risk Group 4 Containment
waste double
• Lethal, pathogenic agent ended
• Readily transmittable autoclave
• direct, indirect (through
• Effective treatment and preventive the wall),
measures not usually available filtered air

BIOSAFETY LEVELS
ACCESS
1. The international biohazard warning symbol
and sign (Figure 1) must be displayed on the
doors of the rooms where microorganisms of
Risk Group 2 or higher risk groups are
handled
2. Only authorized persons should be allowed
to enter the laboratory working areas.
3. Laboratory doors should be kept closed.
4. Children should not be authorized or allowed
to enter laboratory working areas.
5. Access to animal houses should be specially
authorized.
6. No animals should be admitted other than
those involved in the work of the laboratory.
PERSONAL PROTECTION
1. Laboratory coveralls, gowns or uniforms
must be worn at all times for work in the
laboratory.
2. Appropriate gloves must be worn for all
procedures that may involve direct or
accidental contact with blood, body fluids
and other potentially infectious materials or
infected animals. After use, gloves should be
removed aseptically and hands must then be
washed.
3. Personnel must wash their hands after
handling infectious materials and animals,
and before they leave the laboratory working
areas.
4. Safety glasses, face shields (visors) or other
protective devices must be worn when it is
necessary to protect the eyes and face from
splashes, impacting objects and sources of
artificial ultraviolet radiation.
5. It is prohibited to wear protective laboratory
clothing outside the laboratory, e.g. in
canteens, coffee rooms, offices, libraries,
staff rooms and toilets.
6. Open-toed footwear must not be worn in
laboratories.
7. Eating, drinking, smoking, applying
cosmetics and handling contact lenses is
prohibited in the laboratory working areas.
8. Storing human foods or drinks anywhere in
the laboratory working areas is prohibited.
9. Protective laboratory clothing that has been
used in the laboratory must not be stored in
the same lockers or cupboards as street
clothing.
PROCEDURES
1. Pipetting by mouth must be strictly forbidden.
2. Materials must not be placed in the mouth.
Labels must not be licked.
3. All technical procedures should be
performed in a way that minimizes the
formation of aerosols and droplets.
4. The use of hypodermic needles and syringes
should be limited. They must not be used as
substitutes for pipetting devices or for any
purpose other than parenteral injection or
aspiration of fluids from laboratory animals.
5. All spills, accidents and overt or potential
exposures to infectious materials must be
reported to the laboratory supervisor. A
written record of such accidents and
incidents should be maintained.
6. A written procedure for the clean-up of all
spills must be developed and followed.
7. Contaminated liquids must be
decontaminated (chemically or physically)
before discharge to the sanitary sewer. An
effluent treatment system may be required,
depending on the risk assessment for the
agent(s) being handled.
8. Written documents that are expected to be
removed from the laboratory need to be
protected from contamination while in the
laboratory
LABORATORY WORKING AREAS
1. The laboratory should be kept neat, clean
and free of materials that are not pertinent to
the work.
 2. Work surfaces must be decontaminated after
any spill of potentially dangerous material
and at the end of the working day.
3. All contaminated materials, specimens and
cultures must be decontaminated before
disposal or cleaning for reuse.
4. Packing and transportation must follow
applicable national and/or international
regulations.
5. When windows can be opened, they should
be fitted with arthropod-proof screens.
BIOSAFETY MANAGEMENT
1. It is the responsibility of the laboratory
director (the person who has immediate
responsibility for the laboratory) to ensure
the development and adoption of a biosafety
management plan and a safety or operations
manual.
2. The laboratory supervisor (reporting to the
laboratory director) should ensure that
regular training in laboratory safety is
provided.
3. Personnel should be advised of special
hazards, and required to read the safety or
operations manual and follow standard
practices and procedures. The laboratory
supervisor should make sure that all
personnel understand these. A copy of the
safety or operations manual should be
available in the laboratory.
4. There should be an arthropod and rodent
control programme.
5. Appropriate medical evaluation, surveillance
and treatment should be provided for all
personnel in case of need, and adequate
medical records should be maintained.
LABORATORY DESIGN AND FACILITIES
In designing a laboratory and assigning certain types
of work to it, special attention should be paid to
conditions that are known to pose safety problems.
These include:
1. Formation of aerosols
2. Work with large volumes and/or high
concentrations of microorganisms
3. Overcrowding and too much equipment
4. Infestation with rodents and arthropods
5. Unauthorized entrance
6. Workflow: use of specific samples and
reagents
DESIGN FEATURES
1. Ample space must be provided for the safe
conduct of laboratory work and for cleaning
and maintenance.
2. Walls, ceilings and floors should be smooth,
easy to clean, impermeable to liquids and
resistant to the chemicals and disinfectants
normally used in the laboratory. Floors
should be slip-resistant.
3. Bench tops should be impervious to water
and resistant to disinfectants, acids, alkalis,
organic solvents and moderate heat.
4. Illumination should be adequate for all
activities. Undesirable reflections and glare
should be avoided.
5. Laboratory furniture should be sturdy. Open
spaces between and under benches,
cabinets and equipment should be
accessible for cleaning.
6. Storage space must be adequate to hold
supplies for immediate use and thus prevent
clutter on bench tops and in aisles. Additional
long-term storage space, conveniently
located outside the laboratory working areas,
should also be provided.
7. Space and facilities should be provided for
the safe handling and storage of solvents,
radioactive materials, and compressed and
liquefied gases.
8. Facilities for storing outer garments and
personal items should be provided outside
the laboratory working areas.
9. Facilities for eating and drinking and for rest
should be provided outside the laboratory
working areas.
10. Hand-washing basins, with running water if
possible, should be provided in each
laboratory room, preferably near the exit
door.
11. Doors should have vision panels,
appropriate fire ratings, and preferably be
self-closing.
12. At Biosafety Level 2, an autoclave or other
means of decontamination should be
available in appropriate proximity to the
laboratory.
13. Safety systems should cover fire, electrical
emergencies, emergency shower and
eyewash facilities.
14. First-aid areas or rooms suitably equipped
and readily accessible should be available
15. In the planning of new facilities,
consideration should be given to the
provision of mechanical ventilation systems
that provide an inward flow of air without
recirculation. If there is no mechanical
ventilation, windows should be able to be
opened and should be fitted with arthropod-
proof screens.
16. A dependable supply of good quality water is
essential. There should be no cross
connections between sources of laboratory
and drinking-water supplies. An anti-back
flow device should be fitted to protect the
public water system.
17. There should be a reliable and adequate
electricity supply and emergency lighting to
permit safe exit. A stand-by generator is
desirable for the support of essential
equipment, such as incubators, biological
safety cabinets, freezers, etc., and for the
ventilation of animal cages.
18. There should be a reliable and adequate
supply of gas. Good maintenance of the
installation is mandatory.
LABORATORY EQUIPMENT
1. Designed to prevent or limit contact between
the operator and the infectious material
2. Constructed of materials that are
impermeable to liquids, resistant to corrosion
and meet structural requirements
3. Fabricated to be free of burrs, sharp edges
and unguarded moving parts
4. Designed, constructed and installed to
facilitate simple operation and provide for
ease of maintenance, cleaning,
decontamination and certification testing;
glassware and other breakable materials
should be avoided, whenever possible
SAME AS BIOSAFETY LEVEL 1
ACCESS
• Personal protection
• Procedures
• Laboratory working areas
• Biosafety management
• Laboratory design and facilities
• Design features
ESSENTIAL BIOSAFETY EQUIPMENT
1. Pipetting aids – to avoid mouth pipetting.
Many different designs are available.
2. Biological safety cabinets, to be used
whenever:
• infectious materials are handled; such
materials may be centrifuged in the open
laboratory if sealed centrifuge safety
cups are used and if they are loaded and
unloaded in a biological safety cabinet
• there is an increased risk of airborne
infection
• procedures with a high potential for
producing aerosols are used; these may
include centrifugation, grinding, blending,
vigorous shaking or mixing, sonic
disruption, opening of containers of
infectious materials whose internal
pressure may be different from the
ambient pressure, intranasal inoculation
of animals, and harvesting of infectious
tissues from animals and eggs.
3. Plastic disposable transfer loops.
Alternatively, electric transfer loop
incinerators may be used inside the
biological safety cabinet to reduce aerosol
production.
4. Screw-capped tubes and bottles.
5. Autoclaves or other appropriate means to
decontaminate infectious materials.
 6. Plastic disposable Pasteur pipettes,
whenever available, to avoid glass.
7. Equipment such as autoclaves and biological
safety cabinets must be validated with
appropriate methods before being taken into
use. Recertification should take place at
regular intervals, according to the
manufacturer’s instruction
ESSENTIAL BIOSAFETY EQUIPMENT
• The containment laboratory – Biosafety
Level 3 is designed and provided for work
with Risk Group 3 microorganisms and with
large volumes or high concentrations of
• Risk Group 2 microorganisms that pose an
increased risk of aerosol spread. Biosafety
• Level 3 containment requires the
strengthening of the operational and safety
programmes over and above those for basic
laboratories – Biosafety Levels 1 and
• The guidelines given in this chapter are
presented in the form of additions to those for
basic laboratories – Biosafety Levels 1 and
2, which must therefore be applied before
those specific for the containment laboratory
– Biosafety Level 3. The major additions and
changes are in:
1. Code of practice
2. Laboratory design and facilities
3. Health and medical surveillance.
CODE OF PRACTICE
The code of practice for basic laboratories –
Biosafety Levels 1 and 2 applies except where
modified as follows.
1. The international biohazard warning symbol
and sign displayed on laboratory access
doors must identify the biosafety level and
the name of the laboratory supervisor who
controls access, and indicate any special
conditions for entry into the area, e.g.
immunization.
2. Laboratory protective clothing must be of the
type with solid-front or wrap-around gowns,
scrub suits, coveralls, head covering and,
where appropriate, shoe covers or dedicated
shoes. Front-buttoned standard laboratory
coats are unsuitable, as are sleeves that do
not fully cover the forearms
• Laboratory protective clothing must not
be worn outside the laboratory, and it
must be decontaminated before it is
laundered. The removal of street clothing
and change into dedicated laboratory
clothing may be warranted when working
with certain agents (e.g. agricultural or
zoonotic agents).
3. Open manipulations of all potentially
infectious material must be conducted within
a biological safety cabinet or other primary
containment device
4. Respiratory protective equipment may be
necessary for some laboratory procedures or
working with animals infected with certain
pathogens
LABORATORY DESIGN AND FACILITIES
The laboratory design and facilities for basic
laboratories – Biosafety Levels 1 and 2 apply except
where modified as follows:
1. The laboratory must be separated from the
areas that are open to unrestricted traffic flow
within the building. Additional separation
may be achieved by placing the laboratory at
the blind end of a corridor, or constructing a
partition and door or access through an
anteroom (e.g. a double-door entry or basic
laboratory – Biosafety Level 2), describing a
specific area designed to maintain the
pressure differential between the laboratory
and its adjacent space. The anteroom should
have facilities for separating clean and dirty
clothing and a shower may also be
necessary.
2. Anteroom doors may be self-closing and
interlocking so that only one door is open at
 a time. A break-through panel may be
provided for emergency exit use.
3. Surfaces of walls, floors and ceilings should
be water-resistant and easy to clean.
Openings through these surfaces (e.g. for
service pipes) should be sealed to facilitate
decontamination of the room(s).
4. The laboratory room must be sealable for
decontamination. Air-ducting systems must
be constructed to permit gaseous
decontamination.
5. Windows must be closed, sealed and break-
resistant.
6. A hand-washing station with hands-free
controls should be provided near each exit
door.
7. There must be a controlled ventilation
system that maintains a directional airflow
into the laboratory room. A visual monitoring
device with or without alarm(s) should be
installed so that staff can at all times ensure
that proper directional airflow into the
laboratory room is maintained.
8. The building ventilation system must be so
constructed that air from the containment
laboratory – Biosafety Level 3 is not
recirculated to other areas within the
building. Air may be high-efficiency
particulate air (HEPA) filtered, reconditioned
and recirculated within that laboratory. When
exhaust air from the laboratory (other than
from biological safety cabinets) is discharged
to the outside of the building, it must be
dispersed away from occupied buildings and
air intakes. Depending on the agents in use,
this air may be discharged through HEPA
filters. A heating, ventilation and air-
conditioning (HVAC) control system may be
installed to prevent sustained positive
pressurization of the laboratory.
Consideration should be given to the
installation of audible or clearly visible alarms
to notify personnel of HVAC system failure.
THE CONTAINMENT LABORATORY – BIOSAFETY
LEVEL 3
LABORATORY DESIGN AND FACILITIES
1. All HEPA filters must be installed in a manner
that permits gaseous decontamination and
testing.
2. Biological safety cabinets should be sited
away from walking areas and out of
crosscurrents from doors and ventilation
systems (see Chapter 10).
3. The exhaust air from Class I or Class II
biological safety cabinets which will have
been passed through HEPA filters, must be
discharged in such a
• way as to avoid interference with the air
balance of the cabinet or the building
exhaust system.
4. 12. An autoclave for the decontamination of
contaminated waste material should be
available in the containment laboratory. If
infectious waste has to be removed from the
containment laboratory for decontamination
and disposal, it must be transported in
sealed, unbreakable and leakproof
containers according to national or
international regulations, as appropriate.
5. 13. Backflow-precaution devices must be
fitted to the water supply. Vacuum lines
should be protected with liquid disinfectant
traps and HEPA filters, or their equivalent.
Alternative vacuum pumps should also be
properly protected with traps and filters.
6. 14. The containment laboratory – Biosafety
Level 3 facility design and operational
procedures should be documented.
LABORATORY EQUIPMENT
• The principles for the selection of laboratory
equipment, including biological safety
cabinets are the same as for the basic
laboratory – Biosafety Level 2.
• However, at Biosafety Level 3, manipulation
of all potentially infectious material must be
conducted within a biological safety cabinet
or other primary containment device.
Consideration should be given to equipment
such as centrifuges, which will need
additional containment accessories, for
 example, safety buckets or containment
rotors.
• Some centrifuges and other equipment, such
as cell-sorting instruments for use with
infected cells, may need additional local
exhaust ventilation with HEPA filtration for
efficient containment
THE MAXIMUM CONTAINMENT LABORATORY –
BIOSAFETY LEVEL 4
The maximum containment laboratory –
Biosafety Level 4 is designed for work with Risk
Group 4 microorganisms. Before such a laboratory
is constructed and put into operation, intensive
consultations should be held with institutions that
have had experience of operating a similar facility.
Operational maximum containment laboratories –
Biosafety Level 4 should be under the control of
national or other appropriate health authorities.
CODE OF PRACTICE
The code of practice for Biosafety Level 3
applies except where modified as follows:
1. The two-person rule should apply, whereby
no individual ever works alone. This is
particularly important if working in a
Biosafety Level 4 suit facility.
2. A complete change of clothing and shoes is
required prior to entering and upon exiting
the laboratory.
3. Personnel must be trained in emergency
extraction procedures in the event of
personnel injury or illness.
4. A method of communication for routine and
emergency contacts must be established
between personnel working within the
maximum containment laboratory –
Biosafety Level 4 and support personnel
outside the laboratory
LABORATORY DESIGN AND FACILITIES
The features of a containment laboratory –
Biosafety Level 3 also apply to a maximum
containment laboratory – Biosafety Level 4 with the
addition of the following.
1. Primary containment. An efficient primary
containment system must be in place,
consisting of one or a combination of the
following
• Class III cabinet laboratory. Passage
through a minimum of two doors prior to
entering the rooms containing the Class
III biological safety cabinet(s) (cabinet
room) is required. In this laboratory
configuration the Class III biological
safety cabinet provides the primary
containment.
• A personnel shower with inner and outer
changing rooms is necessary. Supplies
and materials that are not brought into
the cabinet room through the changing
area are introduced through a double-
door autoclave or fumigation chamber.
Once the outer door is securely closed,
staff inside the laboratory can open the
inner door to retrieve the materials. The
doors of the autoclave or fumigation
chamber are interlocked in such a way
that the outer door cannot open unless
the autoclave has been operated through
a sterilization cycle or the fumigation
chamber has been decontaminated
• Suit laboratory. A protective suit
laboratory with self-contained breathing
apparatus differs significantly in design
and facility requirements from a Biosafety
Level 4 laboratory with Class III biological
safety cabinets. The rooms in the
protective suit laboratory are arranged so
as to direct personnel through the
changing and decontamination areas
prior to entering areas where infectious
materials are manipulated. A suit
decontamination shower must be
provided and used by personnel leaving
the containment laboratory area. A
separate personnel shower with inner
and outer changing rooms is also
provided.
• Personnel who enter the suit area are
required to don a one-piece, positively
pressurized, HEPA-filtered, supplied-air
suit. Air to the suit must be provided by a
system that has a 100% redundant
capability with an independent source of
air, for use in the event of an emergency.
Entry into the suit laboratory is through
an airlock fitted with airtight doors. An
 appropriate warning system for
personnel working in the suit laboratory
must be provided for use in the event of
mechanical system or air failure
2. Controlled access. The maximum
containment laboratory – Biosafety Level 4
must be located in a separate building or in a
clearly delineated zone within a secure
building. Entry and exit of personnel and
supplies must be through an airlock or pass-
through system. On entering, personnel
must put on a complete change of clothing;
before leaving, they should shower before
putting on their street clothing.
• Controlled air system. Negative
pressure must be maintained in the
facility. Both
• supply and exhaust air must be HEPA-
filtered.
• — Class III cabinet laboratory. The
supply air to the Class III biological safety
cabinet(s) may be drawn from within the
room through a HEPA filter mounted on
the cabinet or supplied directly through
the supply air system. Exhaust air from
the Class III biological safety cabinet
must pass through two HEPA filters prior
to release outdoors. The cabinet must be
operated at negative pressure to the
surrounding laboratory at all times. A
dedicated non-recirculating ventilating
system for the cabinet laboratory is
required.
• Suit laboratory. Dedicated room air
supply and exhaust systems are
required. The supply and exhaust
components of the ventilating system are
balanced to provide directional airflow
within the suit area from the area of least
hazard to the area(s) of greatest potential
hazard. Redundant exhaust fans are
required to ensure that the facility
remains under negative pressure at all
times. The differential pressures within
the suit laboratory and between the suit
laboratory and adjacent areas must be
monitored. Airflow in the supply and
exhaust components of the ventilating
system must be monitored, and an
appropriate system of controls must be
used to prevent pressurization of the suit
laboratory.
• HEPA-filtered supply air must be
provided to the suit area,
decontamination shower and
decontamination airlocks or chambers.
Exhaust air from the suit laboratory must
be passed through a series of two HEPA
filters prior to release outdoors.
Alternatively, after double HEPA
filtration, exhaust air may be recirculated,
but only within the suit laboratory. Under
no circumstances shall the exhaust air
from the Biosafety Level 4 suit laboratory
be recirculated to other areas. Extreme
caution must be exercised if recirculation
of air within the suit laboratory is elected.
3. Decontamination of effluents. All effluents
from the suit area, decontamination
chamber, decontamination shower, or Class
III biological safety cabinet must be
decontaminated before final discharge. Heat
treatment is the preferred method.
• Effluents may also require correction to a
neutral pH prior to discharge. Water from
the personnel shower and toilet may be
discharged directly to the sanitary sewer
without treatment.
4. Sterilization of waste and materials. A
double-door, pass-through autoclave must
be available in the laboratory area. Other
methods of decontamination must be
vailable for equipment and items that cannot
withstand steam sterilization.
5. Airlock entry ports for specimens,
materials and animals must be provided.
6. Emergency power and dedicated power
supply line(s) must b provided.
7. Containment drain(s) must be installed.
 TYPES OF CABINETS
• Fume Hood
o Removes toxic chemical (ducting
sys./ductless)
o No HEPA filter -> not for biohazard
agents
• Laminar Flow Cabinet (LFC)
o Product protection (no personnel
protection)
o Not for biohazard agents or chemical
fumes
• Biohazard Safety Cabinet (BSC)
o Class I BSC: Personnel and
Environment Protection
o Class II & III BSC: Personnel,
Product and Environment Protection
o HEPA filters (not for chemical vapors)
BIOLOGICAL SAFETY CABINETS
• BSCs provide effective primary containment
for work with infectious material or toxins
when they are properly maintained and used
in conjunction with good laboratory
techniques
BASIC PRINCIPLE
• Personnel protection is provided through a
continuous stream of inward air, known as
inflow, which helps prevent aerosols from
escaping through the front opening.
• The exhaust air, which is exhausted into the
surrounding containment zone or directly to
the outside atmosphere, is HEPA-filtered to
protect the environment.
HEPA & ULPA Filter
HEPA: High Efficiency Particulate Air ULPA: Ultra
Low Penetration Air
Important definitions:
- HEPA: 99.99% - at 0.3 microns
- ULPA: 99.999% - at 0.12 microns
Note: The “classical” definition of HEPA filter is
99.97% at 0.3 microns, but nowadays all BSC and
LF in US use 99.99% at 0.3 mm
Particle Size Comparison

HEPA/ULPA CAPABILITY
Removes a broad range of airborne contaminants:

• Fine dust
• Smoke CLASS II BSC
• Bacteria (typical size: 500 to 0.3 micron) • Negative-pressure ventilated cabinet
• Provides HEPA-filtered, recirculated airflow
• Soot
within the cabinet
• Pollen
• Exhaust air is HEPA-filtered
• Radioactive particles
• Provides personnel and product protection
• Impurity ion -> can affect Integrated Circuit
• Types of Class II BSCs
speed
o Class II A: HEPA filtered air is
CLASS I BSC discharged into the room
• 100% Exhaust o Class II B: HEPA filtered air is
• Inflow velocity 75 fpm minimum discharged out of the room
• BSL 1 –3 Usage CLASS II TYPE A1
• Personnel protection only • 30% Exhaust, 70% Re-circulate
• CDC/NIH recommends a glove- port panel • Negative pressure plenum (Changed 2007)
for use with small amounts of radionuclides
• Inflow velocity 75 fpm minimum
when exhausted
• BSL 1 –3 Usage
• Typical uses today: Toxic powder weighing,
• Personnel and Product protection
necropsy
• Minute amounts of non-volatile toxic
• Maybe thimble/air gap or hard connected to
chemicals and radionuclides if
a exhaust system when proper precautions
canopy/thimble exhausted
are taken
• Typical uses today: Bacterial, Viral, Fungal,
Parasitic

CLASS II TYPE A2
• 30% Exhaust, 70% Re-circulate
• Negative pressure plenum
• Inflow velocity 100 fpm minimum
• BSL 1 –3 Usage
• Personnel and Product protection
• Minute amounts of volatile toxic chemicals • Must be hard connected with typical
and radionuclides if canopy/thimble exhaust requirement being 700-1,200
exhausted CFM at Ϯ.Ϭ” w.g.
• Typical uses today: Bacterial, Viral, Fungal, • Must have interlocked internal blower
Parasitic, Arbor- viruses with audible and visual alarm for exhaust
failure
• Typical uses today: Bacterial, Viral,
Fungal, Parasitic, Arbor-viruses, Prion,
Cytotoxics

CLASS II TYPE B1
• 70% Exhaust, 30% Re-circulate
• Negative pressure plenum
• Inflow velocity 100 fpm minimum
• BSL 1 –3 Usage
• Personnel and Product protection
• Minute amounts of volatile toxic chemicals
and radionuclides
• Must be hard connected with typical exhaust
requirement being 300-500 CFM at ϭ.Ϭ” w.g.
• Must have interlocked internal blower with
audible and visual alarm for exhaust failure
• Typical uses today: Bacterial, Viral, Fungal,
Parasitic, Arbor-viruses

CLASS II TYPE B2
• 100% Exhaust
• Negative pressure plenum
• Inflow velocity 100 fpm minimum
• BSL 1 –3 Usage
• Personnel and Product protection
• Small amounts of volatile toxic chemicals
and radionuclides

INTERNATIONAL STANDARDS FOR CLASS II
• US Standard ANSI/NSF49
• European Standard EN12469
• Japanese Industrial Standard JIS K3800
• South African Standard SABS VC
8041:2001
• British Standard BS5726*
• German Standard DIN12950 Teil 10*
• French Standard NF X44-201:1984*
*now obsolete. Replaced with the harmonized
EN12469
CLASS III BSC
• 100% Exhaust Glove Box
• Negative Pressure at Ϭ.5” w.g. minimum
• Double HEPA Filter Exhaust
• BSL 4
• Personnel and Product Protection
• Small amounts of volatile toxic chemicals
and radionuclides
• Must be hard connected with typical
exhaust requirement being 50-100 CFM
at 0.5 w.g.
• Must have negative pressure alarm for
cabinet or exhaust failure
• Typical uses today: Toxic Powders, BSL
4 Agents
PROPER USE
• Standard operating procedures (SOPs) to be
followed by facility personnel is strongly
recommended to encourage the proper and
consistent use of a BSC by personnel to
prevent exposures and the release of
pathogens and toxins.
START-UP CONSIDERATIONS
• Check that the sash is at the appropriate
height. Adjust stool height so that the user’s
underarms are level with the bottom of the
sash.
• Check the pressure gauges to verify that
readings are within the acceptable range.
• If present, test the airflow alarm and ensure
it is switched to the "on" position.
• Confirm inward airflow by holding a tissue at
the middle of the edge of the sash to
establish that it is drawn in.
• Disinfect the interior surfaces with a
disinfectant effective against the infectious
material and toxins used in the laboratory,
allowing an appropriate contact time.
• If a corrosive disinfectant is used, the surface
should be rinsed with water after disinfection.
• Assemble all materials required for
manipulation and load into the BSC.
• Care should be taken not to overcrowd or
block the front or rear grilles to prevent the
appropriate airflow patterns from being
compromised.
• When there is significant potential for splatter
or splashes to occur during manipulations of
infectious material or toxins, the work area
should be lined with a plastic-backed
absorbent pad.
• Place aerosol generating equipment (e.g.,
vortex mixer, sonicator) towards the back of
the BSC, without blocking the rear grille.
• After loading material in the BSC, allow
sufficient time for the air to purge and the
airflow to stabilize before initiating work.
• This will be specified in the manufacturer's
instructions, and is generally 3-5 minutes.
WORKING IN THE BSC
• Perform operations as far to the rear of the
work area as reasonable.
• Ensure that elbows and arms do not rest on
the grille or work surface.
• Avoid excessive movement of hands and
arms through the front opening. Such
movements disrupt the air curtain at the front
of the BSC, which can allow contaminants to
enter or escape the BSC.
• Arms should enter and exit the BSC slowly
and perpendicular to the front opening.
• Keep a bottle of an appropriate disinfectant
in the BSC while work is performed to avoid
having to move hands outside of the BSC.
• Segregate non- contaminated ("clean") items
from contaminated ("dirty") items. Work
should always flow from "clean" to "dirty"
areas.
• Material should be discarded in a waste
container located towards the rear of the
cabinet workspace. Do not discard materials
in containers outside of the cabinet.
• Decontaminate the surface of all objects in
the BSC in the event of a spill.
• The work area, including the inside surface
of the window, should be decontaminated
while the BSC remains in operation.
• Natural gas and propane should not be used
in a BSC; sustained open flames (e.g.,
Bunsen burner) in BSCs are prohibited. On-
demand open flames (e.g., touch- plate
microburners) are to be avoided as they
create turbulence in the BSC, disrupt airflow
patterns, and can damage the HEPA filter
(CBS Matrix 4.6).
• Non-flame alternatives (e.g.,
microincinerator, or sterile disposable
inoculation loops) should be used whenever
possible.
• Equipment creating air movement (e.g.,
vacuum pumps, centrifuges) may affect the
integrity of the airflow and should not be used
within the BSC.
• Windows that open should be kept closed
when the BSC is in use.
the pathogens in use, allowing an
appropriate contact time.
• If a corrosive disinfectant is used, the surface
should be rinsed with water after disinfection
to avoid corrosion of the stainless steel
surfaces.
• Routinely remove the work surface and
disinfect the tray beneath it.
• Disinfect the interior surfaces of the BSC,
including sides, back, lights, and interior of
the glass, with a disinfectant effective against
the pathogens in use, allowing an
appropriate contact time.
• If a corrosive disinfectant is used, the surface
should be rinsed with water after disinfection
to avoid corrosion of the stainless steel
surfaces.
• Routinely remove the work surface and
disinfect the tray beneath it.
• Routinely wipe the surface of the lights within
the BSC with a suitable cleaner or
disinfectant (e.g., ethanol).
UV LAMPS
• Germicidal UV lamps are not substitutes
for proper cleaning of BSC workzone
• May cause performance degradation
• May compromise personnel safety when
proper precautions are not taken

COMPLETION OF WORK IN THE BSC

• Upon completion of work, allow sufficient
time for the air in the BSC to purge (i.e., pass
through the filter) before disrupting the air
curtain by removing hands or unloading
material from the BSC.
• The purge time will vary by model and can be
up to several minutes.
• Close or cover all containers.
• Surface decontaminate items before
removing them from the BSC.
• Disinfect the interior surfaces of the BSC,
including sides, back, lights, and interior of
the glass, with a disinfectant effective against
 BIORISK BIORISK MANAGEMENT: THE AMP MODEL
Laboratory biosafety: containment principles,
technologies, and practices implemented to prevent
unintentional exposure to pathogens and toxins, or
their unintentional release.

Laboratory biosecurity: protection, control and

accountability for valuable biological materials within
laboratories, in order to prevent their unauthorized
access, loss, theft, misuse, diversion or intentional
release.

INTRODUCTION TO
LABORATORY RISK ASSESSMENTS
A laboratory biorisk assessment is an
analytical procedure designed to characterize and
evaluate safety and security risks in a laboratory.

To be comprehensive:

A biosafety risk assessment should

WHAT IS BIORISK?
Risk associated with biological materials
Biorisk = Biosafety + Biosecurity Risks
KEY COMPONENTS OF BIORISK MANAGEMENT
BIORISK ASSESSMENT
Process of identifying the hazards and
evaluating the risks associated with biological
agents and toxins, taking into account the adequacy
of any existing controls, and deciding whether or not
the risks are acceptable
consider every activity and procedure conducted
in a laboratory that involves infectious disease
agents.
A laboratory biosecurity risk assessment
should consider every asset, adversary and
vulnerability in an institution and its component
laboratories and units.
A biorisk assessment allows a laboratory to
determine the relative level of risk its different
activities pose, and helps guide risk mitigation
decisions so these are targeted to the most
important risk.

BIORISK MITIGATION
Actions and control measures that are put
into place to reduce or eliminate the risks associated
with biological agents and toxins

BIORISK PERFORMANCE
Improving biorisk management by recording,
measuring, and evaluating organizational actions
and outcomes to reduce biorisk.
 WHAT IS RISK? BIOSAFETY RISK ASSESSMENT
Risk is the likelihood of an undesirable event A Risk Assessment is a procedure that
happening, that involves a specific hazard or threat analyzes a particular process or situation in order to
and has consequences determine the likelihood and consequences of a
certain adverse event.
Risk = f (likelihood, consequences)
In Laboratory Biosafety, we are concerned
CONSEQUENCES with preventing unintentional adverse events
Risk is a function of both the Likelihood of involving infectious disease agents.
something happening and Consequences of that
occurrence To properly conduct a laboratory biosafety
risk assessment, it is important first to gather
Risk certain information about the laboratory procedures
involving biological agents and toxins, as well as
Let’s consider the previous question in terms information on the agents and toxins themselves.
of Likelihood and Consequences, and the graph
on the right. FACTORS THAT AFFECT LIKELIHOOD AND/OR
CONSEQUENCES?
R = f (L, C) • Agent Properties
o Pathogenicity
RISK
o Virulence
o Host range Communicability
Very o Transmission
High o Environmental Stability
• Procedures
Likelihood

High o PPE
o Training
Moderate o SOPs
o Equipment used
Low
RISK CHARACTERIZATION
Very As you can see many of the factors regarding
Low
laboratory biosafety risk rely on the agent
characteristics and the laboratory procedures.
Risk Consequences
The risk of exposure to an agent is
dependent on these factors.
For the following scenarios, draw a STAR
where the risk would fall on the graph.
 • The difficulty of acquiring the agent
• The difficulty of processing the agent into a
suitable quantity in a suitable form
• The difficulty of disseminating the agent to
cause harm

Determining the potential consequences of

the malicious use (consequences) of a particular
agent or toxin should involve assessing the
following:

• The physical impact of an attack on a

population
• The impact of an attack on the economy
• The impact of changes in public perception
• The impact on facility operations

ADVERSARY CHARACTERIZATION
Adversary Characterization is the process
of determining specific attributes of potential
adversaries that enable them to pose a threat to a
biological agent or toxin.

In the security community, Adversary

BIOSAFETY RISK ASSESSMENT
Characterization is also known as Threat
This exercise should be repeated with every
Assessment.
organism and every procedure conducted in a
laboratory or facility. Some characteristics of potential
adversaries that could help determine the risk they
Doing this in a comprehensive manner is one
pose, include:
way to conduct a facility-wide risk assessment,
which would then be, quite simply, the collection of • Motive
the individual risk assessments for the individual • Means
procedures conducted in a laboratory or facility.
• Opportunity
BIOSECURITY RISK CHARACTERIZATION
Analyzing each of these characteristics in terms
Characterizing biosecurity risk includes
of likelihood and consequences is necessary for a
an in- depth analysis of laboratory assets, potential
biosecurity risk assessment.
adversaries, and laboratory vulnerabilities.
The question of opportunity raises the issue of
ASSET CHARACTERIZATION
insider versus outsider threat.
Asset Characterization is the process of
gathering information about the biological agents An insider is a person who has authorized
and toxins that could potentially be targeted by access to a facility, its units (such as laboratories),
notional adversaries. and its assets.

These biological agents and toxins will be An outsider is a person who does not have
referred to as “assets”. authorized access.

Determining the ease or difficulty of Insiders tend to pose a greater threat than
malicious use (likelihood) should involve outsiders because they typically have both greater
assessing the following: means and opportunity than an outsider.
 Insiders, however, do not necessarily have
different motives than outsiders.
SCENARIOS
Another useful tool for Biosecurity Risk
Assessment is to work through possible scenarios
to detect any vulnerabilities in the biosecurity
management program.
Each evaluated scenario should involve a
specific biological agent, a specific adversary, and
a particular way that adversary will attempt to steal
and misuse the agent or toxin.
Keep in mind that it is important to have a
screening process to limit the number of
scenarios generated, say by considering only those
scenarios involving biological agents capable of
causing significant harm.
The criteria used for screening should be
documented in the assessment.
EXERCISE:
We will work together, through a series of
scenarios to practice characterizing biosecurity
risk.
This exercise could be repeated for every
asset and adversary in a given scenario in a
laboratory or facility.
Doing this in a comprehensive manner is one
way to conduct a facility-wide biosecurity risk
assessment, which would then be, quite simply, the
collection of the individual risk assessments for the
laboratory or facility.
BIORISK CHARACTERIZATION
It is important that the Risk
Characterization process be as robust as possible.
Comparability is the ability trust the
accuracy of differences between assessments, due
to similarities in their bases, assumptions,
procedures and protocols.
Repeatability is the ability to conduct the
same process in the same way for the same hazard
or threat and situation over a period of time, or for
different hazards, threats, and situations at the same
time.
BIORAM
One available tool to aid in the laboratory risk
assessment process is the
BIOSECURITY RAM (BIORAM).
BioRAM is a computerized risk
assessment tool developed by Sandia National
Laboratories, in partnership with the international
community, to facilitate laboratory biosafety and
biosecurity risk assessments by simplifying risk
characterization.
BioRAM uses only one of several possible
risk assessment methodologies.
It is based on the input of biosafety experts
and validated around the world. The BioRAM tool
helps determine relative risk levels in a comparable
and repeatable way.
http://biosecurity.sandia.gov/BioRAM/
RISK EVALUATION
Risk Evaluation is a crucial intermediary
step between Risk Characterization and taking
active steps towards mitigating risk.
Risk Evaluation is the process of
determining, subjectively, whether a risk is high or
low, and whether it’s acceptable or not.
WHAT IS “ACCEPTABLE” RISK?
The evaluation of risk is highly related to
the concept of Risk Acceptance.
Risk evaluation and acceptance can vary
with culture, experience, resources,
management, and even current events.
 Unfortunately, there is no systematic way of An institution that considers a certain risk
evaluating risk and determining risk acceptability. high might be motivated to spend a large amount
This will depend on the perceptions of of resources mitigating that risk.
individuals, institutions, and the community.
Another institution that considers the same
• Individual risk to be moderate might decide to spend a small
o Professional goals amount of resources in mitigation instead.
o Financial goals
o Educational goals KEY MESSAGES
o Notoriety • A risk assessment is defined as a procedure
o Personal health that analyzes a particular process or
• Institution situation in order to determine the likelihood
o Legal issues and consequences of a certain adverse
o Rules/Regulations Compliance event and will be unique to each laboratory.
• Community • To be comprehensive, a laboratory biosafety
o Health and well-being of the risk assessment should consider every
community activity and procedure conducted in a
o Educational/professional laboratory that involves infectious disease
opportunities agents.
• A biosafety risk assessment allows a
If an institution finds a particular risk laboratory to determine the relative level of
unacceptable, it will either cease the work resulting risk its different activities pose, and helps
in that unacceptable risk, or it will find ways to guide risk mitigation decisions so these are
mitigate that risk to a more acceptable level. targeted to the most important risk.
• Risk Evaluation is a crucial intermediary step
between Risk Characterization and taking
active steps towards mitigating risk and is the
process of determining whether a particular
risk is in fact acceptable or not to a facility or
institution
• A biosecurity risk assessment is an analytical
procedure designed to characterize security
risks.
• The results of a biosecurity risk assessment
will be unique to each institution and each
laboratory or unity within that institution.
• To be comprehensive, a laboratory
biosecurity risk assessment should consider
ever asset, as well as vulnerability in an
institution and its component laboratories
and units.
• A biosecurity risk assessment allows an
institution and its component units to
determine the relative level of security risk
they face, and helps guide risk mitigation
decisions so these are targeted to the most
important risks.
 REFERENCE MATERIALS: Who got infected, where and how?
BIOSAFETY/BIORISK MANAGEMENT
WHO Biosafety Guidelines (2004) but no Who Where How
international standards
Singapor Male BSL3 lab, Inappropriat
- Difficult to develop a national standard or
e graduat Environment e lab
guidelines
e al Health procedures
- Is physical protection enough to ensure Institute and cross-
student contaminatio
safety? (are the other social elements
relevant to the issue?) n of West
Nile virus
Laboratory Biorisk Management Standard (CWA- with SARS
15793:2008) CoV

͞“ The CWA 15793:2008 is the first internationally Taiwan Male BSL4 lab, Was working
recognized management standard to specifically lab Inst. Of on SARS
address hazards associated with microbiological scientis Preventive CoV. Found
laboratories at all containment level t Medicine, a spillage of
National material
- ͞The standard also provides structured Defense disinfected
approached to manage risk associated with Medical with 70%
people, facilities and working procedures in Center ethanol and
laboratory environments.͟ cleaned
WHY BIORISK MANAGEMENT? (BRM) manually
BIOSAFETY + BIOSECURITY= BIORISK (+) SARS -
Environment
al samples
from handle
of alcohol
spray bottle
and switch
panel of
cabinet
 The risk associated with biological COMPONENTS OF A BIORISK MANAGEMENT
materials in the laboratory has a safety and a PROGRAM
security component

Laboratory biosafety: containment

principles, technologies, and practices implemented
to prevent unintentional exposure to pathogens
and toxins, or their unintentional release

PROTECTING PEOPLE FROM DANGEROUS

PATHOGENS
Laboratory biosecurity: institutional and
personal security measures designed to prevent the
loss, theft, misuse, diversion, or intentional release
of pathogens and toxins

PROTECTING PATHOGENS FROM DANGEROUS

PEOPLE
Laboratory biosafety manual, Third edition (World
Health Organization, 2004)

LABORATORY BIORISK MANAGEMENT

System or process to control safety and
security risks associated with the handling or INFLUENCES TO MANAGEMENT DECISION
storage and disposal of biological agents and toxins • Perception of Risk
in laboratories and facilities
– (Risk Tolerant VS Risk Averse) influenced
by:

• Financial

• Political

• Cultural

• Communication

• Geography
 Pathogen

• Risk group? ROT/MOT?

• Agent stability and ID50?
• Concentration?
• Availability of effective prophylaxis or
therapy? Antibiotic resistance?
• PSDS/MSDS (Public Health Agency of
Canada Association or ABSA)

Procedures
Likelihood is the probability an event
• Type of laboratory procedures? occurring
Personnel Consequence is the severity of an event
• Skill level and vulnerability of at-risk DETERMINING LIKELIHOOD OF AN EVENT
personnel? MATRIX NO. 1
LEVEL DESCRIPTOR LIKELIHOOD –
Personnel protective equipment
DESCRIPTION
• Appropriate combination of personal
protective clothing and safety equipment? 1 Rare May occur only in
exceptional
Place circumstances

• Appropriate facility and equipment for work 2 Unlikely Could occur at some
to be done? time

3 Possible Might occur at some

time
RISK ASSESSMENT
• Involves team work 4 Likely Will probably occur in
• identify all the risks : 5Ps most circumstances

PATHOGEN PROCEDURES PERSONNEL PE 5 Almost Certain Expected to occur in

Place most circumstances

• identify the specific hazard or threat

• determine the consequences of an
identified risk LEVEL DESCRIPTOR CONSEQUENCE –
• identify all the existing controls and any DESCRIPTION
additional ones that need to be applied
1 Insignificant No injuries, low
HAZARD, THREAT, AND RISK financial loss
A hazard is an object that can cause harm
2 Minor First aid treatment, on
A threat is a person who has intent and/or site release
ability to cause harm to other people, animals, or the immediately contained
institution
3 Moderate Medical treatment
A risk can be based on either a hazard required, on site
and/or a threat release contained with
 outside assistance, EXAMPLE OF RA (ONLY)
high financial loss

4 Major Extensive injuries, loss

of production
capability, off site
release with no
detrimental effects,
major financial loss

5 Catastrophic Death, toxic release off

site with detrimental
effect, huge financial
loss

LIKELIHO CONSEQUENCES
OD
Insignific Min Modera Maj Catastrop
ant (1) or te (3) or hic (5)
(2) (4)

(5) Almost M M H H H
Certain

(4) Likely M M M H H

(3) L M M H H
Possible

(2) Unlikely L L M M H

(1) Rare L L M M H

H High risk immediate action required

M Moderate risk; management responsibility

must be specified

L Low risk; manage by routine procedures

RISK ANALYSIS
HAZARD RISK CONSEQUENCE

No SOPs. Work
outside BSC. No mask.
No face shield. No
vaccines.
 LAB PROCEDURES THAT CAN PRODUCE
AEROSOLS
• Pipetting
• Mixing
• Shaking RISK MITIGATION
• Centrifugation CONTROL MEASURES
• Grinding
Elimination Removing the risk
• Blending
• Vortexing Substitution Substitution of a serious
• Pouring pathogen with one this is much
• Loading syringes less pathogenic
• Harvesting tissue, eggs
• Lasers, cell sorters Controls: Physical changes to work
• Injecting /intranasal innoculation of stations, equipment, materials,
Engineering production facilities, or any
animals
• Sonic Disruption other relevant aspect of the
• Opening Lyophilized Cultures work environment that reduce
• Flaming bacteriologic loops or prevent exposure to hazards
• Opening vessels at non-ambient
Administrative Policies, standards and
pressures, fermenters, freezer vials
guidelines
• Changing animal bedding
• Homogenizers Practices and Processes and activities
THE AMP MODEL OF LABORATORY BIORISK Procedures
MANAGEMENT PPE Devices worn by the worker to
protect against hazards

IMPLEMENTING MITIGATION MEASURES

Ideally, you should first consider elimination or
substitution

A combination of control measures should be

used based on their effectiveness and your ability to
implement them

ADVANTAGES/DISADVANTAGES
Control Advantages Disadvantage
Measures* s
 Engineering Efficient, Cost, POINTS TO CONSIDER
eliminates complexity • Breaking the chain to manage the risk
hazard • Pathogen: substitute a non-pathogen
Significantly (avirulent strain)
reduces the • Reservoir of pathogen: eliminate
potential and reservoir (treat cooling tower for algae,
the level of Legionella)
exposure to • Portal of escape: prevent splashes,
pathogens. aerosols
• Transmission: sharps precautions
Administrativ Authority Indirect • Route of entry/infectious dose: block with
e approach approach, PPE; use in low concentration/volume
addresses the • Susceptible host: immunize, enhance
human factor immune system
Practices and SOP based Training and Reŵeŵďer: ͞AĐĐeptaďle Risk͟
Procedures (standardize supervision
d approach) requirements THE "WOW" EFFECT
• A robust methodological approach to risk
PPE Ease of use, Does not mitigation gives you the ability to:
relative cost eliminate • Justify decisions
hazard: if PPE • Evaluate the impact of certain risk
fails exposure mitigation decisions
happens, • Compare the cost effectiveness of
uncomfortable, various risk mitigation decisions
limits ability

EXAMPLE OF RA + MITIGATION
* A combination of different measures is needed to RISK ANALYSIS
be effective

RISK MITIGATION
PERSONAL PROTECTIVE EQUIPMENT (PPE)

• Last control in the hierarchy of controls

• Should be used with other controls.
• However, in many laboratories it is the first
control implemented, and sometimes the
only control
o Eye protection
o Gloves
o Face shields
o Hair nets
o Ear plugs (when sonicating)
o Protective clothing (gowns)
o Footwear
o Respiratory Protection
 • Encouraging the institute or company
equipping BSL-2/3 facility and good
BioSafety system by government

Ex.1 Giving merits on research grant application

Ex.2 Financial or Technical support

• International cooperation etc.

PLANTING BIOSAFETY CULTURE IN RESEARCHER

Why required?

Meaningless for BSL-2/3 facility without end-

PROPOSAL FOR SOLUTION
users’ practical compliance with BioSafety system
PLANT
based on deep understanding what BioSafety is for.
BIOSAFETY CULTURE
Researcher can Have…
BioSafety CULTURE by organic and systemic
• Less priority for BioSafety than Research
operation & management.
• Too much confidence
Thus, it requires multilateral approaches to o Ignore BioSafety regulations
• Too much fear
• Executive o Lose confidence of working @
▪ BioSafety Manager BSL-3
• End-user (Researcher) • Too many worries about punishment from
supervisor
Planting BioSafety culture in Executive o Hide accident, incident & doubtful
• Why required? cases

Impossible to build & manage BSL-2/3 without HOW TO PLANT IT IN RESEARCHER

continuous financial support from institute BY TRAINING
based on deep understanding what BioSafety is for. • Providing BioSafety Training
o To Principle Investigators
Because BSL-ϯ /high ĐoŶtaiŶŵeŶt Laď faĐilities o To IBC members
ŵeaŶs…. • Inviting BioSafety Trainer /Consultant
• Visual education (DVD)
• Construction of building & facility • BioSafety open lecture
• Purchasing equipment like BSCs, Autoclave • BSL-3 specific training
etc. o Theoretical training
• Validation & Maintenance of Equip. & Facility o Practical training
• Education & Training cost o Emergency training including spill
• Running cost clean up, evacuation thrill, fire etc
• Reorganizing or newly preparing internal
organization & regulations HOW TO PLANT IT IN RESEARCHER
• Closing BSL- 3 experiment periodically for BY GOOD COMMUNICATION
revalidation • Prepare various communication routes
o BSL-3 Specific website or intranet
HOW TO PLANT BIOSAFETY IN EXECUTIVE? o E-mail
• By Laws & Regulations o Poster & Notice board : frequent
• By Deep understanding of BioSafety exposure
o Face to face : Listen to voice from
field!
 o Induce Researcher’s Interest
o Simple & Clear contents
o Utilize Photo, Safety Sign & Color
o Fun approach

HOW TO PLANT BIOSAFETY CULTURE TO

RESEARCHER?
• APPROACH with SCIENTIFIC LOGIC!
• PUNISHMENT is NOT SOLUTION !
• OPEN TRANSPARENT/
COMMUNICATION!
• BUILD UP TRUST RELATIONSHIP!
• SIMPLE, CLEAR & INTERESTING
APPROACH

EXAMPLE 1: SAFETY LABEL OR SIGN

EXAMPLE 2: PHOTO
 EXAMPLE 3: POSTER AND NOTICE
EXAMPLE 4: CAMPAIGN POSTER
EXAMPLE 5: CREATE CHARACTERS
SPILL RESPONSE
an act or process of containing and/or preventing the
expansion of a substance.
Purpose:
• Reduce extent of risk to human life
• Prevent material entering sewers or
waterways
• Prevent contaminating surrounding areas
• Reduce contamination of adjacent chemicals
• Ensure responders practice A.L.A.R.A.
concept
• “As Low As Reasonably Achievable.”
ALARA CONCERNS EXPOSURE TO PERSONS,
ENVIRONMENT AND EQUIPMENT
Purpose:
• Prevent contaminating surrounding areas
• Prevent material entering sewers or
waterways
• Reduce contamination of adjacent chemicals
• Reduce extent of hazard to human life
• Ensure responders practice A.L.A.R.A.
concept (As Low As Reasonably Achievable)
NATIONAL REGULATIONS
• DENR DAO 2013-22 (rev. 2004-36)
▪ DAO 29-1992 (IRR of RA 6969); RA
6969: Toxic substances and
hazardous and nuclear waste control
act of 1990
• DOH Health care WM manual 3rd Ed
• DOLE DO 2014-136
▪ Guidelines for the implementation of
Globally Harmonized System (GHS)
in chemical safety program in workplace.
• DENR DAO 2015-09 & EMB MC 2015-01
RULES AND PROCEDURES FOR THE
IMPLEMENTATION OF THE GHS OF
CLASSIFICATION AND LABELING OF CHEMICALS.
Display the title overhead then expose each line
one at a time on the first and succeeding overheads:
• If you have taken the opportunity to copy the
regulations, then hand them out now. If your
audience has copies of the WorkSafeBC
Occupational Health & Safety Regulation,
have them refer to the regulations.
• I will now take some time to fully explain the
WorkSafeBC policy and WorkSafeBC
Regulation requirements. This may take
 some time as I illustrate and discuss the
points. However, the time spent is very useful
because it also serves as a roadmap of our
Emergency Preparedness and Response
Program. You can compare what is required
to what we have in our program.
• “Comprehensive emergency contingency
plans to mitigate and combat spills and
accidents involving chemical substances
and/or hazardous waste - DENR
• “Procedures for dealing with spillage should
specify safe handling operation and
appropriate protective clothing - DOH
The WorkSafeBC Occupational Health and
Safety Regulation Sections that apply are 4.13-4.17,
4.69, 5.85, 5.97-5.102, 6.125-6.126, 8.36(1), 9.37,
and Part 32
I WILL NOW BRIEFLY EXPLAIN WHAT THESE
REGULATIONS TELL US.
• They tell us that a risk assessment must be
completed in any workplace where a need for
EVACUATION or RESCUE might arise. This
risk assessment must take into consideration
factors such as:
• The presence of toxic process gases like
chlorine or ammonia
• The existence of materials onsite that could
pose a risk to workers or fire fighters in the
event of emergency (for example, are there
fuel tanks or other flammable or explosives
on site?)
• They must take into account any risk posed
by emergencies at adjacent workplaces (for
example, is our facility located near a fuel
storage area, near hazardous industries,
close to rails where dangerous good might
be shipped?)
When a risk is identified, we are required to
ensure that written procedures and policies are
implemented to eliminate or minimize the risk.
Written procedures are required, at a minimum, for
work of the following types:
• Where there is a risk of entrapment
• Where there are persons who require
physical assistance to be moved
• With hazardous substances
• In confined spaces
• At high angles
• Underground
• On or over water
You might ask:
What is meant by entrapment?
You might answer :
A situation where the entrance to an area is
closed off or cannot be accessed in the event of
emergency.
Emergency exit routes must be provided and
marked if regular exits could become dangerous or
unusable in the case of an emergency.
If failure of the lighting system would cause a
risk to workers, an emergency lighting system must
be provided for the workplace and exit routes.
ROLES AND RESPONSIBILITIES
CWA 15793: Laboratory biorisk management

You might ask:

Can anyone give me an example of

something that could pose a risk to fire fighters?

You might answer:

Display this overhead as you introduce the
Large volumes of paints, large propane Responsibilities section.
tanks, chlorine, ammonia, and fuel storage.
 I will now outline the RESPONSIBILITIES
that apply in this program. I will give the basic
responsibilities for several appointments. LATER in
the presentation I will amplify some of these job
descriptions and provide more information on just
HOW they live up to their responsibilities.
Use this overhead to outline what you intend
to present during this part of the presentation.
Expose the lines one at a time reading the line as it
is exposed.
During this segment of the presentation, I intend to
explain the following responsibilities:
The responsibilities of [[Corporation]] in the
program:
• Manager responsibilities
• The Emergency Coordinator
• Supervisor responsibilities
• An Emergency Warden’s responsibilities
• Workers’ responsibilities; and finally we’ll
discuss
• The Joint Health & Safety Committee’s
responsibilities
[[Corporation]] is responsible for ensuring that
appropriate procedures are in place to prevent
emergencies where at all possible and for dealing
effectively with emergency incidents when they do
occur. Specifically, [[Corporation]] will:
• Ensure emergency risk assessments are
conducted and documented
• Design and maintain the workplace
emergency evacuation and rescue program
• Ensure that all facilities have accessible exit
routes
• Ensure that exit routes are appropriately
marked and have emergency lighting as
required
You might ask:
Do we have emergency lighting and how
should it be checked?
You might answer:
We have emergency lighting that will be
activated in the event of a power failure. It can be
checked by pushing the test button on the unit to see
whether or not it will work. This should be part of the
safety inspections.
• Ensure local emergency response plans are
in place
• Ensure that workers are trained in fire
prevention, emergency evacuation and
rescue where required
• Appoint an EMERGENCY COORDINATOR
and delegate authority for emergency
management
Establish policy to emphasize that
emergency wardens have the ultimate authority
during an emergency event evacuation, including
drills
Managers are responsible for:
• Recruiting emergency wardens
• Ensuring or assigning the posting of
emergency plans
• Assigning responsibility to an individual to
post floor plans, establish and identify muster
stations, and maintain emergency lighting
equipment
• Ensuring that emergency evacuation and
rescue risk assessments are completed
• Develop or assist departmental supervisors
in developing site specific emergency
procedures, including those assisting the
disabled during an emergency
• Communicate the results of emergency
hazard identification and risk assessment to
workers
• Communicate with the emergency
coordinator, outside agencies and
emergency supervisory personnel, in the
event of an emergency and as required
The Emergency Coordinator is responsible for:
• Identifying positions, operational groups,
worksites, jobs, tasks, activities, situations,
etc., that may require emergency response
 • Reviewing and annually updating risk
assessments on the need for evacuation and
rescue
• Compiling and maintaining emergency
procedures, including communications,
specific rescue procedures and operational
guidelines, in cooperation with operational
groups
• Requesting and ensuring, by contract for
service or agreement for reciprocal service,
assistance for emergency rescue, by outside
agencies, as identified and required by risk
assessments
• Designating workers who will assist disabled
individuals during emergency evacuation
procedures
• Making available floor plans showing
evacuation routes and location of emergency
equipment
• Making available a template for site specific
emergency plans
You might ask:
Can anyone tell me who is the emergency
coordinator for our organization?
You might answer:
By giving the name of the emergency
coordinator.
Designated Supervisors are responsible
for ensuring that workers:
• Are aware of and understand the policies,
procedures and work arrangements that are
in place to prevent emergencies
• Have been introduced to, understand, and
are able to follow emergency procedures
• Are trained in fire prevention, emergency
evacuation and rescue, as appropriate and
applicable
• Are aware of the hazards due to emergency
response and rescue activities
• Know how to request emergency evacuation
and rescue
• Are aware of the resources available to help
them if they experience trouble dealing with
emergency evacuation and rescue
Emergency wardens are responsible to:
• Familiarize themselves with the emergency
procedures, exit routes, fire alarm pull
stations, fire extinguisher locations, and
assembly points
• Know the location and name of the first aid
attendants, and location of first aid supplies
• Assist in the orientation of new employees on
the emergency procedures
You might ask:
Has anyone here received an orientation on
the emergency preparedness program?
You might answer:
There is now an orientation in place as part
of this program.
In cooperation with supervisors, recruit
workers to assist in the evacuation of disabled
persons during an emergency
In the event of an evacuation the emergency
wardens are responsible to:
• Identify themselves by putting on their
EMERGENCY WARDEN hardhat and high
visibility vest
• Enter each area for which they are
responsible, including washrooms, and
direct occupants to leave the building
• Ensure that persons designated to assist in
the evacuation of workers who need
assistance are available
• Ensure that everyone has left the building
• Report to the DESIGNATED EMERGENCY
SUPERVISOR on the state of evacuation of
the building
• Prevent re-entry of the building
Workers are responsible for:
 • Providing input into risk assessments
• Participating in education, training activities
and drills for emergency evacuation and
rescue
• Following the workplace procedures for
emergency evacuation and rescue
• Accepting and following instructions of
EMERGENCY WARDENS and
EMERGENCY SUPERVISORY
PERSONNEL

The Joint Occupational Health and Safety

(JOHS) Committee will review the effectiveness of
drills and make recommendations to management
on possible corrective actions as a result of
emergency evacuation and rescue.
You might ask:
What are some of the things the safety
committee might look for during drills?
• Minimize traffic in the area
• Store liquid wastes in secondary containers
• Regularly inspect containers to ensure their
integrity
• Be aware of evacuation routes and
emergency equipment
1. HAZARD IDENTIFICATION
MARKINGS LABELS SHIPPING PAPERS

You might answer:

There is a form in Appendix H to the

program that can be used by someone to observe
the effectiveness of an emergency drill. (You might
want to refer your audience to Appendix H.)

SOME EMERGENCY SITUATIONS

During an emergency (although practicality
SPECIFIC ASSESSMENT FOR EVERY SITUATION
dictates such identification should take place during
• Fire
pre-planning), hazards can be identified by
• Earthquake
markings, labels or shipping papers.
• Floods/ tsunami
• Bomb threat The physical state may also be an indication;
• Power and HVAC color of vapor-if such is produced or color of liquid
• Laboratory accident/ incident spills.
• Spills
• Trips, misuse, sharps, non-conforming Labels as shown will provide product name,
activities, etc. Danger or Warning indication, Precautionary and
Hazard Statements as well as manufacturer
CAUSE OF SPILLS: information.
• Inappropriate handling techniques
• Inappropriate storage containers Once material is identified, other sources
• Damaged storage containers may be used to determine spill response actions.
• Uncontrolled access to chemical storage
• Lack of chemical-related training If you have an in-house spill response team,
• Lack of supervision obtain an Emergency Response Guidebook for your
Response Library. This indicates first-line defensive
actions to promote safety for team members and
other staff.
Sampling and testing kits: time-consuming
Air monitoring instruments: very expensive
Identification can also be made in the field
with sampling and testing kits. This, however, is
time-consuming.
Often used by hazmat teams called to
incidents presenting unknown materials.
1. RISK EVALUATION
• Solid materials easy to recover
• Vapors in confined areas
• May form explosive amounts
• Displace oxygen for breathing
Some solids, if moistened, will product
various gases and/or uncontrolled reactions. These
could endanger responders. Some materials can
act as a catalyst, causing further dangers.
If incompatible liquids combine, violent
reactions are possible. Some are delayed while
others are immediate and devastating. Adding
water to sulfuric acid causes an immediate reaction.
Some metals, reacting with acids evolve hydrogen
gas which is explosive. Acetylene mixing with
chlorine gas will result in a large fire with toxic fumes
being released
LIQUID RELEASE
• Complicated by amount of spilled material
and inherent characteristics.
• Surfaces are contacted and vapors or gases
produced.
Additionally;
• Vapors in confined areas may form explosive
amounts, or
• Displace oxygen for breathing
• Terrain may aid spread; liquids follow the
path of least resistance to storm drains,
sewers or waterways.
• May also contaminate water strata.
• Complicated by amount of spilled material
and inherent characteristics.
• Surfaces are contacted and vapors or gases
produced.
Additionally;
• Vapors in confined areas may form explosive
amounts, or
• Displace oxygen for breathing
• Terrain may aid spread; liquids follow the
path of least resistance to storm drains,
sewers or waterways.
• May also contaminate water strata.
Gas Releases may occur from cylinders or from
processes.
Often compartments cannot be tightly sealed in
trucks.
In engineered facilities, this attempt to “seal” the
location is achieved to some degree by shutting-
down ventilation and air exchange systems.
2. INVENTORY
• Improve both safety and security
management
• Only buy and store amount of material
needed
• Buy the least hazardous materials possible
• Use non-hazardous materials when possible
 3. ENGINEERING AND CONTAINERS • Chemical reactions inside a container or by
mixing with other materials upon release.
• Mechanical due to punctures by forklifts or by
being dropped in transit.

4. SPILL AND PLUG KITS

Engineer Safeguards where you can to

eliminate more costlier spills. These come in the
form of prefabricated drum pallets all the way to
constructing a room so the dimensions can hold one
third of the product in the room. (Containment
rooms.)
• Response Kits are a result of pre-planning.
Example: a room of 55 gallon drums with a • Spill control kits are available for drum spills.
net cubic volume at grade, (measuring 20 ft by 20 ft • Various gallon capacities are also available.
with a 1 foot freeboard). This equals 20 x 20 x 1=400 • Evaluate the possible future needs for your
cubic feet (gross volume). facility. Purchase (or some have constructed
their own kits) as deemed necessary.
Knowing there are 7.48 gallons per cubic
foot, this room, at grade, should hold, 7.48 (round off • Personal Protective Equipment
to 7.5 gallons) 7.5 gallons per cubic foot x 400 cubic (OSHA, NFPA, & SDS)
feet= 3,000 gallons.

With a 55 gallon drum: 3,000 gallons / 55

gallons= 54.5 drums could be held in this room.

BUT, since the room’s gross volume is 400

cubic feet and the net volume is 20% of the gross,
this leaves 80 cubic feet for spillage.

80 cu ft x 7.48 gals per cubic foot=598.4

gallons volume divided by 55 gallons = 10.8 drums
capacity can be held by the net volume of the room.

If the room is protected by a sprinkler system,

recalculate total volume that could be held based on
number of sprinkler heads operating and the GPM
per sprinkler head per minute.

The preplanning process can reveal those

aspects which will work to your benefit during a spill
or be detrimental.

Types of damage causing releases include:

• Thermal: impinged upon by fire.

 EMERGENCY RESPONSE

2. ESTABLISH DECONTAMINATION ZONES

The level of PPE required for each response

level will be dictated by the material’s hazard. Cite
EPA charts and information on the SDS to determine
proper types.

Indicate in your Action Plan which agency

you’ve elected to follow; OSHA or NFPA. If you are
regulated by OSHA, your question is already
answered; you’ll comply with OSHA.

Some industries have their own levels of

3. CLEAN-UP BIOLOGICAL SPILLS
safety for general employees and response
4. REPORT AND REVIEW
personnel.
(SOP in accident/ incident investigation)
The above wallet card shows the determined
5. ROOT CAUSE ANALYSIS
work clothing required by this facility based on the
6. ACT! DO SEMINARS AND DRILLS
hazard of the material.
• Provide training per the standard
The “X” in the lower right column is usually • Use hands-on practical training for simulated
used to direct staff to emergency requirements in situations
PPE and actions for a material. • Train with off-site responders in table top
exercises

CHALLENGES
• Budget
• Chemical disposal/ treatment
• Materials
• Employees/ students: safe culture
• Top management
• Knowledge gaps

Safety is a state of mind...

Be safe…

Be “bio-chemical” safe!

BE SAFE, BE BIOSAFE BE SECURE,BE

BIOSECURE
 HAZARDOUS WASTE MANAGEMENT IN
ACADEMIC INSTITUTIONS
Waste management is a very important aspect
for biological/chemical safety due to

• It has its own set of specialize procedures /

steps to be taken/ to ensure safety
• Different types of hazards i.e.heavy metals,
organic solvents, and resins for chemical,
envelop vs non envelop bacteria, viruses,
prions for biologicals – need specific
procedure for treatment and disposals
• Not only the laboratory workers are involved
in the process, the support staff maintenance
staff/ operators (who might have the least
training in handling hazardous substances)
and the third-party contractors (whose
credentials on giving the specific services
needed should be verified).

ISSUES WITH BIO&CHEMC’L HAZARDS

TRANSMISSION OF DISEASES:
• Direct contact
• Disease vectors

IPCBEE vol.32(2012) © (2012)IACSIT Press,

Singapoore

Challenges to Waste Management Practices in

Indian Health Care Sector

Kamalakanta Muduli1, Akhilesh Barve 2

1 Research Scholar, Indian Institute of Technology,

• Aesthetics: odor, growth of insects/pests Bhubaneswar, Orissa, India,
• Ground water contamination kamalakantam@gmail.com 2 Asst. Prof., Indian
• Eliminations of beneficial microorganism Institute of Technology, Bhubaneswar, Orissa, India,
• Air pollution due to improper incineration akhileshbarve@yahoo.com

R Soc Open Sci. 2017 Mar; 4(3): 160764. PMCID:

PMC5383819 Published online 2017 Mar 22. doi:
10.1098/rsos.160764

Challenges and opportunities associated with

waste management in India

Sunil Kumar,1 Stephen R. Smith,2 Geoff Fowler,2

Costas Velis,3 S. Jyoti Kumar,4 Shashi Arya,1
Rena,1 Rakesh Kumar,1 and Christopher
Cheeseman2
 Limited environmental awareness combined
with low motivation has inhibited innovation and the
adoption of new technologies that could transform
waste management in India. Public attitudes to
waste are also a major barrier to improving SWM in
India.

Long-term waste management planning

requires visionary project development by ULBs, the
private sector and NGOs. The roles and
responsibilities to deliver sustainable systems need
to be defined, with monitoring and evaluation to
monitor progress. Experiences should be shared
between different regions of India and different
social groups. There are a number of research 1. IN-LAB HAZARD REDUCTION
institutes, organizations, NGOs and private sector • Segregation at point of origin
companies working on a holistic approach to SWM, • Segregation of infectious waste with
and future waste management in India must involve multiple hazards
extensive involvement of the informal sector • Use of distinctive, clearly marked
throughout the system. containers or plastic bags
• Use of the universal biological hazard
There is a need to develop training and symbol
capacity building at every level. All Indian school
children should understand the importance of waste As possible, separate
management, the effects of poor waste
• pathology wastes from other medical
management on the environment and public health,
wastes (OMW)
and the role and responsibilities of each individual in
• MW with hazardous chemicals or
the waste management system. This will develop
radioactive waste.
responsible citizens who regard waste as a resource
• sharps waste from OMW
opportunity.
• chemotherapy wastes from OMW
PHILIPPINE REGULATIONS ON WM
2. WASTE CHARACTERIZATION
RA 6969 Toxic Substances and Hazardous
DOH-HEALTHCARE WM GUIDE
and Nuclear Wastes Control Act of 1990

Presidential Decree No. 856 s 1975 “The Code of

Non-infectious dry waste
Sanitation of the Philippines”
Trash Bin/Plastic bags
DOH DC # 156-Cseries of 1993 “Provides
Guideline in Hospital Management”

RA 8749 (Clean Air Act of 1999) Non-infectious wet waste

RA 9003 (Ecological Solid Waste Management Act Trash Bin/Plastic bags (foodstuff)
of 2001)

RA 9275 (Clean Water Art of 2004)

PD 1586 (Environmental Impact Statement System

Law) Infectious Pathologic waste

Plastic bag (double bagging)

 • Do not compact wastes

SHARP WASTE COLLECTION

• Container size and location are critical
Sharps
• Container: Closable and not “reopenable”
Puncture proof container
• Autoclavable?

• Avoid Overfilling

• Cautions:
Radioactive waste
- Container substitution
Lead Storage Containers - Container reuse

LABELING STANDARDS
• Size: minimum 20cm x 30cm (readable -
5m away)
Non-infectious recyclables • Yellow for background and black for
letters
Trash Bin/Plastic bags (bottles) • Scratch proof
• Resistant to tampering and weathering

UNKNOWN CHEMICALS
• Physical description
• Water reactivity
• Water solubility
• pH
• Ignitability (flammability)
• Presence of oxidizers, halogens, radioactive,
biohazardous, toxic constituents, PCBs, and
high odor comp.

3. COLLECTION AND STORAGE

7-POINTS FOR ACADEMIC INSTITUTIONS
1. Labeling standards
2. Facility/ container standards
3. Training requirements
4. Removal of unwanted chemicals
5. Hazardous waste determination
6. Laboratory cleanout
7. Prevention of emergencies and
response

PACKAGING INFECTIOUS WASTES

• Selection of packaging materials
• Integrity during storage and transport,
• Closing/ tying/ sealing as appropriate for the
treatment or transport
• Liquid wastes in capped/ tightly stopped
bottles.
 LABELING STANDARDS: BASIC FORM

LABELING STANDARDS: PICTOGRAM 4. TREATMENT AND DISPOSAL

TSD FACILITIES IN THE PHILIPPINES

STORAGE FACILITY TRANSPORT

a) Accessible (but not outsiders) Wheeled trolleys should be:
b) Enclosed storage and proper ventilation
- Authorized for the purpose
c) Resistant and retain spillage floors
- Easy to load and unload
d) Segregate waste
- No sharp edges
e) Drums
- Easy to clean
Type Contents - disinfect daily

Polyethylene Acids/ Bases TREATMENT

Drums ✓ On-site

Metal Drums Flammables/ solvents/ paints 1. Autoclaving (steam sterilization)

2. Incineration
Fiber Drums Granular materials 3. Thermal inactivation
4. Gas/Vapor Sterilization
5. Chemical Disinfection
 6. Sterilization by irradiation (microwave)

✓ Off-site TREATMENT: MIXED WASTE

• Open Dumps

o Predominant method of waste

disposal in developing countries
o Illegal dumping problems
o Groundwater contamination, air
pollution, pest and health hazards

• Sanitary landfills

• Ocean Dumps

• Exporting Waste

‘GARBAGE IMPERIALISM’
• Within rich nations, poor neighborhoods are
recipients of LULUs (locally unwanted land
uses).
• Toxic wastes are sometimes “recycled” as
building materials, fertilizer or soil
amendments.
 5. HAZARDOUS WASTE MANIFEST
6. RECORDS & RECORD KEEPING
PREPARING YOUR FAMILY FOR EMERGENCIES: A
STEP-BY-STEP GUIDE
• Have you ever thought
about how to prepare
for an emergency?

How would you:

• Look after your family for 72 hours?

• Cope without power or tap water?
• Contact your family and receive
information?

Fast fact:

• Although the majority of the people believe

that having an emergency plan and
emergency kit are important, only
a small minority have actually
created them

Learn the three steps to getting prepared:

• Know the risks

• Make a plan

• Get a kit

Opportunity Common misconceptions:

Opportunity of Academic Institutions • Most emergencies are short-lived

• I won’t ever have to deal with an emergency
PERSONEL where I live
• There are a lot of emergencies I just
PERSONNEL
can’t prepare for
-Institution LGUs • Preparing takes too much time

Waste Management Safety and Security Program 1. Most forms of emergencies are short lived

• Events such as Hurricane Juan (2003) in

Nova Scotia, floods in Alberta and
Newfoundland (2005) and winter storms in
British Columbia (2006-2007) are hazards
that occurred with little notice and had lasting
consequences. For example, the severe
storms in British Columbia that occurred over
several consecutive months led to boil water
advisories, extensive property damage and
power outages affecting over 200,00 people.
*
 8. Power outages
9. Winter storms
2. I won’t ever have to deal with an emergency 10. Tornadoes
where I live 11. Tsunamis or storm surges
• One in three Canadians live in regions that 12. Wildfires
are susceptible to earthquakes and most 13. Other:
reside in areas subject to flooding, __________________________
transportation accidents, hazardous spills MAKE A PLAN
and severe storms • Use your Emergency Preparedness
Guide as an outline
• Tip to presenter: If possible, give examples
of incidents in your local area. Check out the • Photocopy your plan
Canadian Disaster Database at • Keep copies of your plan in
safe and memorable places
• http://publicsafety.gc.ca/res/em/cdd/inde
TAYLOR FAMILY: FLOOR PLAN
x-en.asp
• Emergency exits
3. There are a lot of emergencies I just can’t • Designate a family
prepare for meeting area
• Escape routes from
• There are common consequences that can neighbourhood
happen in any emergency such as loss of • Ensure help for people
power, water and telephone service or with disabilities
access to food and medical supplies
We will be using the Taylor family as an
4. Preparing takes too much time example of how to start an emergency plan.
• Buying or assembling a kit is easy, and can Here is the example of the Taylor family’s
be even easier when assembled over a home floor plan. Using the floor plan, they will:
period of time
• Locate all emergency exits from each room
*http://www.pep.bc.ca/hazard_preparedness/Histori in your home
cal_Severe_Weather_Nov06.html • Plan escape routes from the neighbourhood
and meet with neighbours to discuss
KNOW THE RISKS KNOW YOUR LOCATION
• Designate a family meeting area and be sure
The consequences of emergencies can be
to share the information with all family
similar, but knowing the risks in your location can
members
help you better prepare..
• Ensure that neighbours with disabilities know
• Step one in preparedness is to Know the they can contact you for help
risks and Know your region. • SAFE TIP: Get first aid training — it can help
save a life!
• Risks can include: (you may want to list
those most relevant to your region) JANE & BOBBY TAYLOR’S PLAN
• School’s emergency policies
1. Blizzards • Updated contact information
2. Droughts • Designate contact persons
3. Earthquakes and make sure your children
4. Extreme cold or heat waves know how to get in touch
5. Floods with them
6. Hurricanes
7. Landslides or avalanches
 If you have children, you will need to make a PLAN FOR HIGH-RISE RESIDENTS
special plan for their safety. For Jane & Bobby • Evacuation plan
Taylor’s plan: • Know your exits
• Extra water in case of
• Find out school or daycare’s emergency power outage
policies, including emergency procedures
and how they will communicate with the If you are a high-rise resident, note that:
Taylor family during an emergency
• Give updated contact information each year • You should know the evacuation plan for
to the school/daycare, including designated your building and the proper response for
contact people for Jane and Bobby should various alarm sounds
their parents be unavailable • You should identify the location of stairwell
• Teach children who their contact people are exits and keep all exits free of obstructions
and how to get in touch with them • People with disabilities should advise their
building manager/superintendent of their
SPECIAL NEEDS PLAN special needs during an emergency
• Health information card
• Grab-and-go bag with MAX’S PLAN
medication, prescriptions, • Location of “pet-friendly”
medical documents shelters/hotel
• Ensure walkers, oxygen • Extra pet food and water
tanks and other in emergency kit
emergency supplies • How will you transport
• Personal support network your pets?

Grandma Taylor has special needs, so she will
need a specialized emergency plan. This may
contain:
• A health information card, with her
medication and allergy list, insurance
information and vaccination history – this can
be stored in several areas, including on her
fridge and in her wallet
• A grab-and-go bag with two weeks of
medication supplies and prescriptions
Also:
The Taylor family’s cat, Max, also has his own
plan in case of an emergency.
• Call around in advance and find a “pet-
friendly” facility or hotel in your area and
further away from home, as not every
shelter/facility accepts animals
• Prepare a similar emergency kit for your pet
as you would for your family – include extra
pet food/water, ID tags, harness, leash and
pet litter box
• Plan how you will gather your pets and how
you will transport them in an emergency

• Ensure assistive equipment, including a Other helpful hints:

walker and an oxygen tank in a secure place
in order to access them quickly in case of an • Choose an out-of-town
emergency contact person
• Create a personal support network that will • Make arrangements
check on her in case a caregiver cannot through friends or
contact her in an emergency cultural centres
• If you have a disability or special needs, • Practice your plan!
include additional items in your emergency • Review your plan
kit according to your needs. For more once a year
information, visit the GetPrepared.ca Before we continue on to Step 3, Get a kit, here are
website some other helpful hints:
 • Choose an out-of-town contact that lives far your kit will make it easier to stay organized
enough away and will not be affected by the during an emergency
same event (e.g. someone in another region
or province)
• Plan for each family member to call or email Three steps to getting prepared:
the same out-of-town contact person in the
event of an emergency • Know the risks
• If you are new to Canada or don’t have an • Make a plan
out-of-town contact, make arrangements • Get a kit
through friends, cultural associations or local
community organizations The steps we reviewed today will help you
• Practice and review the plan at LEAST get yourself and your family prepared for an
once a year to update and refresh your emergency. By:
memory
a) Knowing the risks
PREPARE A KIT b) Making a plan and
To prepare for an emergency that could last 72 c) Getting a kit
hours or more, what would you put in a kit?
...you are taking responsibility for preparing your
Step 3 to emergency preparedness is to Get a kit. family. We all hope that emergencies don’t occur –
but that’s no reason to delay…
• In an emergency, you will need some basic
supplies – be prepared to be self-sufficient,
before help arrives, for at least 72 hours.

GET A KIT
• Water – at least 2 litres of water per person,
per day – include small bottles that can be
carried easily in case of an evacuation order
• Food that won’t spoil, such as canned food,
energy bars and dried foods (remember to
replace the food and water once a year)
• Manual can opener
• First aid kit
• Battery-powered radio or wind-up radio and
extra batteries – use your radio to stay
informed of messages from authorities
• Wind-up Flashlight (and batteries, if
necessary)
• Special needs items, like baby formula and
prescription medications
• Extra keys for your car and house
• Cash in smaller bills, such as $5–$10 bills
and change, as cash registers, etc. may not
work
• A copy of your emergency plan and contact
information
• Important documents such as copies of birth
certificates, passports, wills and insurance in