CHAPTER 1
HISTORY OF MEDICAL TECHNOLOGY
PROFESSION
ANCIENT HISTORY
1ST Medical Diagnosis
 Made by humans, were based on what Ancient
Physicians could observe with their eyes, ears
and human specimens.
BEFORE 400 BC
 Oldest known test on body fluids was done on
urine.
 Urine was poured on the ground and observed to
see whether it attracts insects. If it did, patients
were diagnose with boils (infection)
300 BC
 HIPPOCRATES – Father of Medicine
- Advocates examination of urine to diagnose
and promoted the use of the mind and senses
as diagnostic tools.
- Concluded that the appearance of bubbles,
pus and blood is an indication of kidney
disease or kidney failure in the future.
Urine – first specimen being analyzed
 Pus – WBC
 If WBC is high, there is an infection
 Disease – absence of health
 Galen – describe diabetes as diarrhea of urine
Diabetes > Hyperglycemia
- High sugar on blood
Medieval period: water casting called uroscopy
17th CENTURY
 William Harvey – discovered blood circulation
- English scientist who proved that the heart
acts as a muscular pump propelling the
blood throughout the body in a continuous
cycle (2 mins) through:
 Vivisection – cutting alive
 Ligation – tied off
 Perfusion – passage of fluid through
cardiovascular and lymphatic system to an organ
 Anton van Leeuwenhoek (1684)
- Published the 1st drawing of bacteria as seen
in the microscope
- Saw protozoa using the pond water
- Father of Microbiology
 Robert Hooke
- Used the microscope to document the
existence of cells in vegetables.
 Marcello Malphigi
- Father of Histology ( study of tissues)
- Italian Microscopist
- Served as Physician to Pope Innocent XII
- Famous for his investigations of embryology
of the chick for 21 days
- Histology and Physiology of the glands and
viscera.
 Frederik Dekkers
- Leiden, Netherlands
- observed in 1694 that urine that contained
protein would form a precipitate when boiled
with acetic acid.
18TH CENTURY
 William Hewson (1739-1774)
- English physiologist
- Hexham, Northumberland, England
- showed that when the coagulation of the
blood is delayed, coagulable plasma can be
separated from the cells and removed of the
surface.
- Coagulation - formation in the plasma of a
substance he called “coagulable lymph,”
which is now known as fibrinogen.
 J.W. Tichy - observations of sediments in the
urine of febrile patients (1774)
- Febrile – fever or nervous excitement
 Matthew Dobson (1776)
-
prooved that the sweetness of the urine and
blood serum in diabetes is caused by sugar.
 Francis Home (1780)
- the development of the yeast test for sugar in
diabetic urine
•
1916 – P.A. Kohler developed the colorimeter–
nephelometer.
•
1920 – First clinical laboratory method for
serum phosphorus was established; the use of
venipuncture for diagnostic testing became
widespread.
•
1921 – First clinical laboratory method for
serum magnesium was established.
•
1922 – ASCP (American Society of Clinical
Pathology) was founded in St. Louis, Missouri
•
1925 – American Type Culture Collection was
founded.
•
1926 – Arne Tiselius developed moving
boundary electrophoresis of proteins; Theodor
Svedberg determined the molecular weight of
hemoglobin by ultracentrifugation
19TH CENTURY
•
•
1830 – Gerardus Mulder performed the first
elemental chemical analysis of proteins; and
Joseph Jackson Lister developed an achromatic
microscope and introduced dark-field
microscopy.
1852 – Karl von Vierordt developed a method
for performing accurate blood counts
(hemocytometry);
•
1854 – Jules Duboscq developed the first visual
colorimeter based on Beer’s Law.
•
1869 – Herman Luer invented the glass
hypodermic syringe.
•
•
1872 – Oscar Brefeld developed the use of a
gelatin medium for isolation of fungi in pure
culture.
1928 – George Nicholas Papanicolaou first
reported the ability to recover cancer in vaginal
smears, thus beginning clinical cytology.
•
1929 – Otto Folin introduced the use of the light
filter in colorimetry
•
•
1879 – Paul Ehrlich, a Czech cellular pathologist
and chemist, was enamored with dyes and
developed many methods of drying and fixing
smears using heat. He also discovered mast cells
and classified white blood cells.
1886 – Max Jaffe developed alkaline picrate
method for the determination of createnine.
- R. Gabreus develops the erythrocyte
sedimentation rate (ESR) as an index of severity
of disease
- ESR measures plasma and sedimentation
settlement of rbc; measures inflammation and
sedimentation.
- Max Knoll and Ernst Ruska invented the
electron microscope
20th Century
•
1904 – Christian Bohr discovered the reciprocal
relationship between pH and oxygen content of
hemoglobin (Bohr effect)
•
Martinus Beijerinck obtained the first pure
culture of the sulfur-oxidizing bacterium
Thiobacillus thioparus; the first ultraviolet lamps
and the first practical photoelectric cell were
invented.
•
1911 – Oskar Heimstadlt invented the
fluorenscence microscope.
•
1932 – Ian Cherry and Lathan Crandall
developed the clinical laboratory method for
serum lipase activity.
•
1934 – Commercial development of electron
microscope. 1935 – Beckman Instruments Co.
introduced the first pH meter; ASCP Board of
Registry first required a college degree for
medical technologist certification.
•
1937 – First Blood Bank established at Cook
County Hospital, Chicago, Illinois
•
1938 – Michael Somogyi developed 2 major
clinical laboratory methods for serum and urine
amylase activity; Alexander Gutman developed
the first assay for acid phosphatase.
•
1939 – Edward Joseph Conway and Robert
Cooke developed the first clinical laboratory
method for blood ammonia; American Medical
Technologists (AMT) was founded.
•
1941 – George Nicholas Papanicolaou and
Herbert Traut proved the diagnostic usefulness
of vaginal smears in cervical cancer; Archer
John Porter Martin and Richard Synge separated
amino acids and peptides by chromatography.
•
1943 – Penicillin was successfully used in
therapy. It was found by Paul Erhlich
•
1944 – William Sunderman applied
refractometry of proteins in the clinical
laboratory.
•
1945 – S. Borgstrom develops the whole blood
clotting time test.
•
1946 – The Vacutainer evacuated serum
collection tube was introduced by Becton
•
1954- Polio vaccine was developed
•
1965 – Scanning electron microscope was
developed.
•
1967 – Garry Abelev showed that
alphafetoprotein is elevated in serum of patients
with testicular teratocarcinoma; U.S. enacted the
Clinical Labora
•
1969 – High performance liquid
chromatography (HPLC) became widely applied
in analytical chemistry. tory Improvement
•
1973 – James Westgard introduces Westgard
control rules into clinical laboratory quality
control.
•
1980-Hepatitis B vaccine was developed by
Blumberg
•
1985-PCR was develop by Kary Mullis
•
1998- stem cell was develop by James Thomson
HISTORY OF MEDICAL TECHNOLOGY IN THE
PHILIPPINES
•
In 1944, during the World War II, U.S. bases
were built in the island of Leyte. This made
possible for the U.S. military forces to bring in
members of their health care team in the
Philippines to resolve health problems of the
American soldiers and Filipinos.
•
Real medical facilities were made available to
the Philippines, which includes the 26th Medical
Laboratory of the 6th US Army Brigade. The
said laboratory was located at Quiricada, Sta.
Cruz, Manila, now known as the Public Health
Laboratory, a division of the Manila Health
Department. In February 1944, PHL started
training civilians to become members of the
health care team.
•
The 6th U.S. Army Brigade left the laboratory in
June 1945. The laboratory was endorsed to the
National Department of Health but the
department did not seem to be interested in
pursuing the objectives of laboratory.
•
The World War ended on September 1945,
and barely a month after, the laboratory was
formally re-organized by Dr. Alfredo Pio de
Roda and assisted by Dr. Mariano Icasiano, who
was then the Manila City Health Officer. The
laboratory was later name Manila Public Health
Laboratory.
•
A training program for individuals aspiring to
become laboratory workers was offered in 1947
by Dr. Pio de Roda, in collaboration with Dr.
Prudencia Sta. Ana. Trainees were mostly high
school graduates and paramedical graduates.
The training proved to be ineffective because the
trainees were never motivated and there was no
program that was supposed to last for a definite
period and no certificates were issued to
trainees.
•
Realizing this, Dr. Pio de Roda instructed Dr.
Sta. Ana to prepare a formal syllabus of the
training program. In 1954, the training began
using a syllabus and it was to last for 6 months.
Dr. Tirso Briones joined the two after a short
while.
•
The training program offered by Dr. Pio de
Roda did not last long, for during the same year,
the formal education of Medical Technology in
the Philippines began.
•
1964 – Philippine Association of Medical
Technologists (PAMET) had its first national
convention at FEU Medical Auditorium.
•
1966 – R.A. 4688 (The Clinical Laboratory Act)
was approved.
•
1969 – PAMET was registered at the Securities
and Exchange Commission (SEC); R.A. 5527
(Philippine Medical Technology Act) was
enacted into law.
•
1970 – The Board of Medical Technology was
created pursuant to R.A. 5527; the first licensure
examination for Medical Technology was
conducted; Philippine Association of Schools of
Medical Technology/Hygiene (PASMETH) was
created; PAMET was registered with the
International Association of Medical Laboratory
Technologists (IAMLT
•
1971 – Guidelines on Clinical Internship
Program was drafted, reviewed and finalized and
a curriculum was designed with reference to US
laboratory courses; The Philippine Society for
Microbiology (PSM) was established by selected
senior faculty members of the College of
Agriculture, U.P. Los Baños.
•
1972 – Former President Ferdinand Marcos
declared the 3rd week of September as Medical
Technology week; Declaration of approved.
•
1957 – University of Santo Tomas (UST)
offered Medical Technology as an elective
Martial Law; Philippine Society for
Microbiology and Infectious Diseases (PSMID)
was formally organized.
•
1973 – P.D. (PRESIDENTIAL DEGREE) 223
was approved creating the Professional
Regulation Commission (PRC). PAMET was
officially recognized as the only Accredited
Professional Organization (APO) of registered
Medical Technologists in the Philippines;
Angelina Jose was elected as the first female
president of PAMET.
•
1974 – Sections of R.A. 5527 (2, 3, 4, 7, 8, 11,
13, 16, 17, 21, 29) was amended by P.D. 498.
Significant Events in the History of MT in the
Philippines
 1947 – Creation of the Philippine National Red
Cross (PNRC).
•
1954 – The Philippine Union College (PUC) and
Medical Sanitarium in Baesa, Caloocan offered
the first four-year BS Medical Technology. now
as Adventist University of the Philippines
(AUP)
•
1956 – PUC graduated its first graduate, Dr.
Jesse Umali, who is a successful OBGYN; R.A.
1517 (Blood Banking Law) was to 4th and 5th
year BS Pharmacy students and without the 12month internship training.
•
1960 – Centro Escolar University (CEU) offered
BS Medical Technology and turned out its first
batch of graduates in 1962 consisting of only 8
graduates.
•
1961 – Far Eastern University (FEU) offered
BS Medical Technology under the College of
Medicine and turned out its first batch of
graduates in 1963; The University of the
Philippines also started offering BS Hygiene;
Immaculate Conception College (ICC), now
known as the University of Immaculate
Conception (UIC) in Davao City, offered BS
Medical Technology, the first in Mindanao.
•
1962 – UST formally offered BS Medical
Technology; the University of San Agustin
(USA) offered BS Medical Technology, the first
in the Visayas
•
1963 – An organizational meeting, headed by
Crisanto G. Almario, was held at the Public
Health Laboratory, Manila which was attended
by professionals and members of the academe
from the allied medical profession.
•
1975 – UST Graduate School offered Master of
Science in Medical Technology (MSMT), the
first graduate school to offer MSMT; Pioneer
Educational Review Center (PERC), the first
review center for Medical Technology was
established.
•
1978 – Medical Services of America, Inc.
(MSA) tapped BSMT graduates to undergo a 6month on the job Respiratory Therapy Training
Program and produced the 1st batch of Filipino
Respiratory Therapists in the Philippines; R.A.
5527 was further amended by P.D. 1534.
•
1981 – The Research Institute for Tropical
Medicine (RITM) was formally established with
the signing of E.O. 674, authorizing the creation
of a research facility under the Department of
Health (DOH).
•
1983 – The Philippine Blood Coordinating
Council (PBCC), the professional society
specializing in Blood Banking was created;
Professor Lina C. Somera of the U.P. College of
Public Health was awarded as the first “Most
Outstanding Medical Technologist”.
•
1985 – PAMET gained membership in the
ASEAN Association of Medical Laboratory
Technologists (AAMLT)
•
1986 – PAMET hosted the 2nd ASEAN
Conference in Medical Laboratory
Technologists (ACMLT) in Manila where the
AAMLT Constitution and bylaws were adopted.
•
•
•
2002 – Philippine Society of Medical
Technology Students (PHISMETS) was
organized.
2004 – PWU started offering Certificate in
Phlebotomy, the first TESDA (Technical
Education and Skills Development Authority)
certified short term course on phlebotomy.
2005 – American Society of Clinical Pathology
Board of Registry introduced ASCP
International Certification in the Philippines;
ACTS Review Center was awarded by the
Philippine marketing Excellence Awards as
“The Nation’s Most Outstanding Medical
Review Center”.
•
2006 – Schools and universities updated their
curriculum and changed the name of BSMT to
BMLS (Bachelor of Medical Laboratory
Science) following the release of Memorandum
Order No. 14 2006 of the Commission of Higher
Education (CHED) rationalizing the Medical
Technology education in the Philippines;
Pharmacology was included in the
BSMT/BMLS curriculum.
•
2009 – The first annual Medical Technology
Student Congress was held at Our Lady of
Fatima University – Valenzuela campus; the
National Kidney and Transplant Institute
(NKTI) Medical Laboratory gets the first ISO
15189: 2007 accreditation by the Philippine
Accreditation Office (PAO) in the Philippines.
•
2010 – The first batch of BMLS students
graduated; the first annual Medical Technology
Student Leadership Training and Strategic
Planning was held at ATI-CAR Benguet State
University in La Trinidad, Benguet.
NATURE OF MEDICAL TECHNOLOGY
•
Science concerned with the study of the natural
world and interrelationship among the
biological, psychological and social world
•
Technology is the application of science
•
Medical technology is designed to improve the
detection, diagnosis, treatment and monitoring
of disease
•
Clinical laboratory test play a crucial role in the
detection, diagnosis and treatment of disease
ROLES AND RESPONSIBILITIES OF MEDICAL
TECHNOLOGY PROFESSIONALS
•
•
PERFORM CLINICAL LABORATORY
TESTING
PERFORM SPECIAL PROCEDURES
•
ENSURE ACCURACY AND PRECISION OF
RESULTS
•
BE HONEST IN PRACTICE
•
ENSURE TIMELY DELIVERY OF RESULTS
•
DEMONSTRATES PROFESSIONALISM
•
UPHOLD CONFIDENTIALITY
•
COLLABORATE WITH OTHER HEALTH
PROFESSIONALS
•
CONDUCT RESEARCH
•
INVOLVVEMENT IN HEALTH
PROMOTION PROGRAMS
QUALIFICATIONS OF MLT
•
Board exam result is 70-74.9%
•
Passed Civil Service exam for medical
technician given on March 21, 1969
•
Finished 2 years of college course and has a 1
year experience of working MLT; provided that
for every year of experience in college 2 years of
work maybe substitutes; and provided further
that the applicant has at least 10 years of
experience as MLT of the approval of this
decree.
•
Phlebotomist
-
•
Cytotechnologist
-
•
individual trained to draw blood either for
the laboratory test or blood donations
laboratory personnel who works with the
pathologist to detect changes in body cells
which maybe important in the early
diagnosis of disease
Histotechnologist
DEFINITION TERMS IN RA 5527
Pathologist – a duly registered physician who is
specially trained in methods of laboratory medicine, or
the gross and microscopic study and interpretation of
tissues, secretion and excretions of the human body and
its functions in order to diagnose disease, follow its
course, determine the effectivity of treatment, ascertain
cause of death and advance medicine by means of
research.
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
(BSMT/BS Hygiene) of training and examination is
registered under the provision of this Act.
Medical Laboratory Technicians- 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.
-
•
Nuclear medical technologist
-
•
or called histotechnicians ;personnel
responsible for routine preparation,
processing and staining of biopsies and
tissue specimen for microscopic
examination by pathologist
Health care professionals who work
alongside nuclear physicians. Includes
radiation physics, radionuclides
Toxicologist
-
studies the toxic substances on the
physiological functions of human beings
animals and plants to develop data for use in
consumer protection and safety programs
Lesson 3:Ethics
1-Human Existence and Ethics

Ethics is the moral code that guides how an
individual should behave. As a branch of
knowledge,it deals with moral principles. It is
also about the individual’s search for meaning
while dealing with humans problems which may
be logical (problems reasoning),epistemological
(problems of truth),cosmological (problems of
universe),ethical(problems of
morality),aesthetical(problems of art and
beauty), or scientific problems (problems of
science)(Timbreza 1993).

Human beings are logical beings but human
existence is inexplicable.

Ethical Utilitarianism

School of ethics

Ethics deals with a diverse prescription of
universal concepts and principles that serve as
foundation of moral beliefs.

In many cases ethics can be connected to
morality. For Donal Harrington, morality can be
viewed in different perspectives as a law, as an
inner conviction, as love as personal growth, and
as social transformation. However there are also
nuances between ethics and morality as
illustrated by james Gustafson (1974).
ETHICS
Theoretical
Prescriptions/critiques
 The nature of good
 The nature of
human person
 Criteria of
judgment
MORALITY
Based on principles
practiced by a particular
community
 Fundamental
convictions of
human agent
 Character of moral
agent
 Use of norms
 Situational
Analysis
Ethical Relativism

It is also known as moral relativism is a school
of ethics anchored on the principle that morality
is relative to the norms of a particular culture.

It also acknowledges societal diversity that
every society has a unique moral design and
culture and peoples beliefs are greatly
influenced by culture.

Ethical Pragmatism
Pragmatism is a philosophical approach or
movement that began in the 1870.The term was
coined by Charles Sanders Peirce and further
developed by William James. It is considered as
America’s most distinctive and major
contribution to the field of philosophy. It is more
of a theory on knowledge, truth and meaning
rather than morality.
Founded by two English philosophers Jeremy
Bentham (1748-1832) and John Stuart Mill
(1806-1873). This school of ethics states that the
rightness or wrongness of actions is determined
by their consequences. The utility or usefulness
of an action is determined by the extent to which
it promotes happiness rather than its reverse.
2-Moral issues

There are numerous ethical issues in the field of
medicine that are perceived to be controversial.
Diversity, decision making, compliance, and
governance are some of the concerns that needs
to be considered when doing an ethical review in
the context of the health care profession.
 Abortion
 Abortion is considered illegal in the Philippines.
Article 11, Section 12 of the 1987 Philippine
Constitution states that:
 The state recognizes the sanctity of life and shall
protect and strengthen the family as a basic
autonomous social institution. It shall equally
protect the life of the mother and the life of the
unborn from conception.(Article, Section 12)
 Abortion can be direct, induced or even caused
by natural cases or accidents. In some
instances, abortion becomes necessary when
the life of mother is at stake.
 For anti-abortion groups, abortion is the ultimate
violation of life for it is the act of killing an
individual that is not yet able to speak for
himself or herself
 For those who support abortion, they believe
that pregnant women, especially victims of
rape, should be given the chance to decide for
themselves. It is important to look at abortion
as an ethical issue that requires deeper
understanding.
Euthanasia (Mercy Killing)

It covers the morally accepted behaviour of
individuals in the workplace. The code of ethics
of a particular profession serves as the guiding
principle in the ethical practice of a profession.
As it is necessary in maintaining a healthy and
productive work environment.

Euthanasia is a practice of ending a life
intentionally. It is regarded as a merciful release
of an individual from an incurable sickness, is
terminally ill, to relieve him or her of pain and
suffering.
1. Voluntary euthanasia: is when an individual
gives consent to subject himself or herself to a
pain less death.
2. Non-voluntary euthanasia: is considered when
the permission of the patient to perform the
process is unavailable, like in the case of patient
in a deep comatose, or neonates born with
significant and major birth defects.
Genetic Engineering

It involves genetic manipulations that are
perceived to be against moral standards set by
the society. The following are some procedure
involved in genetic engineering:
1. Genetic screening: is a procedure whose main
purpose is to screen, choose and select the genes
for proper detection of any genetic disease and
other chromosomal malformations. Genetic
screening is usually done for the early diagnosis
of diseases.
2. Genetic interventions: are techniques such as
genetic control, therapy and surgery.
3. Stem-cell therapy: is a form of genetic
engineering that makes use of stem cells to treat
or prevent diseases.
4. In vitro fertilization: is popularly known as
laboratory fertilization.
3-Professional ethics
MEDICAL TERMINOLOGIES
Lesson 4: Medical terminologies and Abbreviations
1- Medical Terminologies
Most medical terms are derived from Greek and Latin
words. Since clinical laboratory personnel are in
constant communication with other health care
personnel, patients and family members on a daily basis,
they need to familiar with the abbreviations and
meanings of common medical terms.
A medical term has 3 basic parts the root words, the
prefix, and the suffix. The root word is the main part of
the medical term that denotes the meaning or the word.
Examples: colo - colon
Phlebo - vein
hemat-blood
aero-air
The prefix is found at the beginning of the term and it
shows how meaning is assigned to the word.
Examples: a/an- without, absence
poly-many
hyper- meaning increased/above
pre-before
The suffix is found at the terminal portion or at the end
of the term. It also denotes the meaning to the root word.
Examples: megaly- enlargement
emia- blood
It is a rule that if the suffix start with a consonant a
combining vowel needs to be used.(usually the letter O).
The combining vowels do not change the meaning of the
root word and is added in order to make the
pronunciation of the word easier. The combining vowels
are added between the root word and the suffix.
Examples: hemat + logy= hematology - study of blood
phlebo + tomy= phlebotomy - the process of cutting in
to the vein using a needle.
The plural form of medical term is made by changing the
end of h word and not by simply adding S, which
follows the irregular nouns.
IU- International Unit
Examples:
IV- Intravenous
AFS- Acid Fast Stain
2PPBS- 2 hours Postprandial Blood Sugar
PCQACL- Philippine Council for Quality Assurance in
the Clinical Laboratories
HIV- Human Immunodeficiency
ICU- Intensive Care Unit
K- Potassium
Na- Sodium
NPO- Nothing Per Orem
BAP- Blood Agar Plate
Brief History of Laboratory Biosafety
> Observing and implementing laboratory safety
precautions are of utmost importance in the medical
technology practice. Individuals who handle and process
microbiological specimen are vulnerable to pathogenic
microorganisms which are possible sources of laboratory
acquired infections (LAI).
2- Abbreviations
Listed below are the commonly encountered
abbreviations in the health care practice.
DOH- Department of Health
CHED- Commission of Higher Education
VDLR- Venereal disease Research Laboratories
AMI- Acute Myocardial Infraction
BUN- Blood Urea Nitrogen
AIDs- Autoimmune disorders/diseases
AIDS- Acquired Immunodeficiency Syndorme
> Laboratory biosafety and biosecurity traces its history
in North America and Western Europe. The origins of
biosafety is rooted in the US biological weapons
program which began in 1943, as ordered by then US
President Franklin Roosevelt and was active during the
Cold War It was eventually terminated by US President
Richard Nixon in 1969. In 1943, Ira L Baldwin became
the first scientific director of Camp Detrick (which
eventually became Fort Detrick), and was tasked with
establishing the biological weapons program for
defensive purposes to enable the United States to
respond if attacked by such weapons. Other contributors
outside the United States included Arnold Wedum who
described the use of mechanical pipettors to prevent
laboratory-acquired infections in 1907 and 1908 (Kruse
(1991), cited by Salerno, 2015). Moreover, ventilated
cabinets, early progenitors to the nearly ubiquitous
engineered control now known as the biological safety
cabinet, were also first documented outside of the US
biological weapons program. In 1909, a pharmaceutical
company in Pennsylvania developed a ventilated cabinet
to prevent infection from mycobacterium tuberculosis.
* In 1996, the US government enacted the Select Agent
Regulations to monitor the transfer of a select list of
biological agents from one facility to another. Slightly
after the terrorist attacks and the anthrax attacks of 2001,
also known as Amerithrax, the US government changed
its perspective. The revised Select Agent Regulations
then required specific security measures for any facility
in the United States that used or stored one or more
agents on the new, longer list of agents
practices.

European Biological Safety Association (EBSA): a
non-profit organization that focuses on encouraging
and communicating among its members information
and issues on biosafety and biosecurity as well as
emerging and standards.

Philippine Biosafety and Biosecurity Association
(PhBBA): created by a multi- disciplinary team
with members coming from the health and
education sectors as well as individuals from the
executive, legislative, and judicial branches of the
government. Also included are members of the
steering committee and technical working groups of
the National Laboratory Biosafety and Biosecurity
Action Plan Task Force established as per DPO No.
2006-2500 dated September 15, 2006. A long term
goal of the association is to assist the DA and DOH
in their efforts to create a national policy and
implement plan for laboratory biosafety and
biosecurity.

Biological Risk Association Philippines (BRAP): a
non-government and non-profit association that
works to serve the emergent concerns of biological
risk management in various professional fields
Local and International Guidelines on Laboratory
Biosafety and Biosecurity
In February 2008, the Comité Européen de
Normalisation (CEN), a European Committee for
Standardization published the CEN Workshop
Agreement 15793 (CWA 15793) which focuses on
laboratory biorisk management. The Workshop offers a
mechanism where stakeholders can develop consensus
standards and requirements in an open process. The
CWA 15793 can be applied to international stakeholders,
however, they do not have the force of regulation while
conformity is voluntary. The CWA 15793 was developed
among experts from 4 different countries including
Argentina, Australia, Belgium, Canada, China, Denmark,
Cermany, Ghana, UK, US, among others. It was updated
in 2011 and intended to maintain a biorisk management
system among diverse organizations and set out
performance-based requirements with the exclusion of
guidance for implementing a national biosafety system.
Since it originated in the European workshop agreement
framework, confusion among countries outside Europe
arose especially in the United States in terms of its
applicability. Nevertheless, the agreement was used until
it officially expired in 2014 (Gronvall, 2015)
Different Organizations in the field of Biosafety
Several organizations across continents have undertaken
initiatives in advocating for laboratory biosafety and
biosecurity

American Biological Safety Association (ABSA): a
regional professional society for biosafety and
biosecurity founded in 1984. It promotes biosafety
as a scientific discipline and provides guidance to
its members on the regulatory regime present in
North America.

Asia-Pacific Biosafety Association (A-PBA): a
group founded in 2005 that acts professional society
for biosafety professionals in the Asia-Pacific
region. Active members of the International
Biosafety Working Group are required to directly
contribute to the development of the best biosafety
Fundamental Concepts of Laboratory Biosafety and
Biosecurity

Defines biosafety as the containment principles,
technologies, and practices that are implemented to
prevent unintentional exposure to pathogen and
toxins or their accidental release.

Biosecurity refers to the protection, control, and
accountability for valuable biological materials
within laboratories, in order to prevent their
unauthorized access, loss, theft, misuse, diversion or
intentional release" (WHO, 2006). "biosafety
protects people from germs" while "biosecurity
protects germs from people."
Classification of Microorganisms According to Risk
Groups
WHO recommends an agent risk group classification for
laboratory use that describes four general risk groups.
Risk group classification for humans and animals is
based on the agent's pathogenicity, mode of
transmission, host range, and the availability of
preventative measures and effective treatment. Are
classified as Risk Group 1, Risk Group 2, Risk Group 3,
Risk Group 4.
Risk group 1: includes microorganisms that are unlikely
to cause human or animal disease. These
microorganisms bring about low individual and
community risk.
Risk group 2: includes microorganisms that are
unlikely to be a significant risk to laboratory workers
and the community. Laboratory exposure may cause
infection, however, effective treatment and preventive
measures are available while the risk of spread is
limited. This risk group bring about moderate individual
risk and limited community risk.
Risk group 3: includes microorganisms that are known
to cause serious diseases to humans or animals and may
present a significant risk to laboratory workers but there
are usually effective preventive measures or treatment
available. They bring about high individual risk, and
limited to moderate community risk
Risk group4: includes microorganisms that are known
to produce life-threatening diseases to humans or
animals.
Categories of Laboratory Biosafety According to Levels
In order to facilitate precautionary measures, CDC
categorized laboratories into four. They are designated in
ascending order, by degree of protection provided to the
personnel, the environment, and the community.
1. Biosafety Level 1 (BSL-1) : is suitable for work
involving viable microorganisms that are defined and
with well-characterized strains known not to cause
disease in humans. Examples are Bacillus subtilis,
Naegleria gruberi. This level is the most appropriate
among undergraduate and secondary educational training
and teaching laboratories.
2. Biosafety Level 2 (BSL-2) : is basically designed for
laboratories that deal with indigenous moderate-risk
agents present in the community. It observes practices,
equipment, and facility design that are applicable to
clinical, diagnostic, and teaching laboratories
consequently observing good microbiological
techniques. Examples are Hepatitis B virus, HIV. BSL-2
is appropriate when work is done with human blood,
body fluids, tissues.
3. Biosafety Level 3 (BSL-3) : puts emphasis on
primary and secondary barriers in the protection from
infectious aerosol exposure. Work with indigenous or
exotic agents with a potential for respiratory
transmission, and may cause serious and potentially
lethal infection are being conducted here. Examples are
Mycobacterium tuberculosis and Coxiella.
4. Biosafety Level 4 (BSL-4) : is required for work
with dangerous and exotic agents that pose high
individual risks of life-threatening diseases that may be
transmitted de the serosal route, for which there are no
available vaccines or treatment. Specific practices, safety
equipment, and appropriate facility design and
construction are required for instance when manipulating
viruses such as the Marburg or the Crimean-Congo
hemorrhagic fever and any other agents known to pose a
high risk of exposure and infection to laboratory
personnel, community, and environment.
Lesson:7 Biorisk Management
Biorisk Management and the AMP Model
Biorisk is the risk associated to biological toxins or
infectious agents. The source of risk may be
unintentional exposure to unauthorized access,
accidental release or loss, theft, misuse, diversion, or
intentional unauthorized release of biohazards.
Biorisk management is the integration of biosafety and
biosecurity to manage risks when working with
biological toxins and infectious agents (CWA 15793
Laboratory Biorisk Management Standard).
Biorisk Management (BRM) is "a system or process to
control safety and security risks associated with the
handling or storage and disposal of biological agents and
toxins in laboratories and facilities BRM encompasses
the identification, understanding, and management
aspects of a system in interrelated processes.
It is divided into three primary components: assessment
(A), mitigation (M), and performance (P),
These components are collectively captured by what is
called the AMP model (World Health Organization,
2010)
. The model requires that control measures be based on a
robust risk assessment, and a continuous evaluation of
effectiveness and suitability of the control measures.
Identified risks can be either mitigated, avoided limited,
transferred to an outside entity, or accepted.
Key Components of Biorisk Managemen
Risk Assessment
The initial step in implementing a biorisk management
process relies on risk assessment which includes the
identification of hazards and characterization of risks
that are possibly present in the laboratory.
Hazard refers to anything in the environment that has
the potential to cause harm while risk is generally
defined as the possibility that something bad or
unpleasant (such as an injury or loss) will happen.
In performing risk assessment , a structured and
repeatable process is followed. It consists of the
following steps:
and guidelines used to control risks. Proficiency and
competency training for laboratory staff is considered an
administrative control.
Define the situation- the risk assessment team must
identify the hazards and risks of the biological agents to
be handled. Next, at-risk hosts, who could be humans or
animals inside and outside the laboratory, must be
identified. The work activities and laboratory
environment including location, procedures, and
equipment should als be defined.
Personal protective equipment (PPE): These are devices
worn by workers to protect them against chemicals,
toxins, and pathogenic hazards in the laboratory
Define the risks -defining the risks must include a
review of how individuals inside and outside the
laboratory may be exposed to the hazards. It could either
be through droplets, inhalation, ingestion, or inoculation
in case a biological agent has been identified as the
hazard.
The last pillar of the biorisk management model is
performance evaluation that involves a systematic
process intended to achieve organizational objectives
and goals.
Characterize the risks- to characterize the overall
biosafety risks, the risk assessment team needs to
compare the likelihood and the consequences of
infection-either qualitatively or quantitatively.
It also helps to highlight biorisk strategies that are not
working effectively and measures that are ineffective or
unnecessary. These can be eliminated or replaced.
Determine if risks are acceptable or not - arising from a
biohazard takes into account the adequacy of any
existing controls and deciding whether or not the biorisk
is acceptable.
Performance Evaluation
The model ensures that the implemented mitigation
measures are indeed reducing or eliminating risks.
Performance management is simply a reevaluation of the
overall mitigation strategy.
Mitigation Procedures
The Second fundamental component of the biorisk
management model is mitigation.
Biorisk mitigation measures are actions and control
measures that are put into places to reduce or eliminate
the risks associated with biological agents and toxins.
There are five major areas of control or measures that
can be employed in mitigating the risk.
Elimination: the most difficult and most effective control
measure, involves the total decision not to work with a
specific biological agent or even not doing the intended
work. Definitely, elimination provides the highest degree
of risk reduction.
Substitution: the second control measure, is the
replacement of the procedures or biological agent with a
similar entity in order to reduce the risks.
Engineering controls: includes physical changes in work
stations, equipment production facilities, or any other
relevant aspect of the work environment that can reduce
or prevent exposure to hazards.
Administrative controls: refers to the policies, standards,
Lesson 8: Nature of the Clinical Laboratory
The Clinical Laboratory
The clinical laboratory is an essential component of
health institutions. Its main task is to provide accurate
and reliable information to medical doctors for the
diagnosis, prognosis, treatment, and management of
diseases . The clinical laboratory is also actively
involved in research, community outreach programs,
surveillance, infection control in the hospital and
community setting, information dissemination, and
evaluation of the applicability of current and innovative
diagnostic technologies. The clinical laboratory is the
place where specimens (eg, blood and other body fluids ,
feces, hair, nails) collected from individuals are
processed, analyzed, preserved, and properly disposed.
Clinical laboratories vary according to size, function,
and the complexity of tests performed
Classification of Clinical Laboratories
According to Function
1- Clinical Pathology: is a clinical laboratory that
focuses on the areas of clinical chemistry,
immunohematology and blood banking. medical
microbiology, immunology and serology, hematology,
parasitology, clinical microscopy, toxicology, therapeutic
drug monitoring, and endocrinology, among others. It is
concerned with the diagnosis treatment of diseases
performed through laboratory testing of blood and other
body fluids.
2-Anatomic Pathology: is a clinical laboratory that
focuses on the areas of histopathology
immunohistopathology, cytology, autopsy, and forensic
pathology among other. It concerned with the diagnosis
of diseases through microscopic examination of tissues
and organ.
According to Institutional Characteristics
1-An institution-based: is a clinical laboratory that
operates within the premises or part of an institution
such as a hospital, school, medical clinic, medical
facility for overseas workers and seafarers, birthing
home, psychiatric facility, drug rehabilitation center, and
others. Hospital-based clinical laboratories are the most
common example of institution- based laboratories.
2. A free-standing clinical laboratory is not part of an
established institution The most common example is a
free-standing out-patient clinical laboratory.
1-Cinical laboratories under the primary category are
licensed to perform basic , routine laboratory testing,
namely, routine urinalysis, routine stool examination,
routine hematology or complete blood count and Gram
staining (if hospital-based). Space requirement is at least
10 square meters.
2-Clinical laboratories secondary category (Hospital and
non hospital-based) are licensed to perform laboratory
tests being done by the primary category clinical
laboratories along with routine clinical chemistry tests
like blood glucose concentrations, blood urea nitrogen,
blood uric acid. blood creatinine, cholesterol
determination. A minimum requirement of 20 square
meters is needed for the floor area.
3- Clinical laboratories under the tertiary category
(Hospital and non hospital based) are licensed to
perform all the laboratory tests performed in the
secondary category laboratory (1)immunology and
serology (2) microbiology, bacteriology, and mycology
(3) special clinical chemistry (4) special hematology
and (5) immunohematology and blood banking.
Tertiary laboratories have a minimum floor area
requirement of at least o square meter. Equipment
requirements include those seen in secondary category
laboratories along with automated chemistry analyzer,
biosafety cabinet class 11, serofuge, among others.
4-National Reference Laboratory is a laboratory in a
government hospital designated by the DOH to provide
special diagnostic functions and services for certain
diseases.
Laws on
of Clinical
the Operation,
Laboratories
Maintenance,
in the Philippines
and Registration
Laws on the Operation, maintenance, and Registration of
Clinical Laboratories in the Philippines
Laws on
of Clinical
the Operation,
Laboratories
Maintenance,
in the Philippines
and Registration
Republic Act No. 4688
According to Ownership
1-Government-owned clinical laboratories are owned,
wholly or partially, by national or local government
units. Examples are the clinical and anatomical
laboratories of DOH run government hospitals like the
San Lazaro Hospital, Jose R. Reyes Memorial Medical
Center.
2-Privately owned clinical laboratories are owned,
established, and operated by an individual , corporation,
institution, association , or organization. Examples are
St. Luke's Medical Center.
According to Service Capability
An act regulating the operation and maintenance of
clinical laboratories and requiring the he registration of
the same with the department of health, providing
penalty for the violation thereof, and for other purposes
SECTION 1. Any person, firm or corporation, operating
and maintaining a clinical laboratory in which body
fluids, tissues, secretions, excretions and radioactivity
from beings or animals are analyzed for the
determination of the presence of pathologic organisms,
processes and/or conditions in the persons or animals
from which they were obtained, shall register and secure
a license annually at the office of the Secretary of
Health: provided, that government hospital laboratories
doing routine or minimum laboratory examinations shall
be exempt from the provisions of this section if their
services are extensions of government regional or central
laboratories.
SECTION 2. It shall be unlawful for any person to be
professionally in-charge of a registered clinical
laboratory unless he is a licensed physician duly
qualified in laboratory medicine and authorized by the
Secretary of Health, such authorization to be renewed
annually, No license shall be granted or renewed by the
Secretary of Health for the operation and maintenance of
a clinical laboratory unless such laboratory is under the
administration, direction and supervision of an
authorized physician, as provided for in the preceding
paragraph.
SECTION 3. The Secretary of Health, through the
Bureau of Research and Laboratories shall be charged
with the responsibility of strictly enforcing the
provisions of this Act and shall authorized to issue such
rules and regulations as may be necessary to carry out its
provisions
SECTION 4. Any person, firm or corporation who
violates any provisions of this Act or the rules and
regulations issued thereunder by the Secretary of Health
shall be punished with imprisonment for not less than
one month but not more than one year, or by a fine of not
less than one thousand pesos nor more than five
thousand pesos, or both such fine and imprisonment, at
the discretion of the court.
SECTION 5. If any section or part of this Act shall be
adjudged by any court of competent jurisdiction to be
invalid, the judgment shall not affect, impair, or
invalidate the remainder thereof.
SECTION 6. The sum of fifty thousand pesos, or so
much thereof as may be necessary, is hereby authorized
to be appropriated, out of any funds in the National
Treasury not otherwise appropriated, to carry into effect
the provisions of this Act.
SECTION 7. All Acts or parts of Acts which are
inconsistent with the provisions of this Act are hereby
repealed
SECTION 8. This Act shall take effect upon its
approval.
Approved, June 18, 1966.
Administrative Order No. 59 s. 2001
Administrative Order No. 59 s. 2001
Rules and Regulation Governing the Establishment,
Operation and Maintenan Clinical Laboratories in
the Philippines
Section 1: Title
This Administrative Order shall be known as the "Rules
and Regulations Governing the Establishment, Operation
and Maintenance of Clinical Laboratories in the
Philippines."
Section 2: Authority
These rules and regulations are issued to implement R.A.
4688: Clinical Laboratory Law consistent with EO. 102
series 1999: Redirecting the Functions and Operations of
the Department of Health. The Department of Health
(DOH), through the Bureau of Health Facilities and
Services (BHFS) in the Health Regulation Cluster, shall
exercise the regulatory functions under these rules and
regulations.
Section 3: Purpose
These rules and regulations are promulgated to protect
and promote the health of the people by ensuring
availability of clinical laboratories that are properly
managed with adequate resources with effective and
efficient performance through compliance with quality
standards.
Section 4:Scope
1-These regulations shall apply to all entities performing
the activities and functions of clinical laboratories which
shall include the examination and analysis of any or all
samples of human and other related tissues, fluids,
secretions, radioactive, or other materials from the
human body for the determination of the existence of
pathogenic organisms, pathologic processes or
conditions in the person from whom such samples are
obtained.
2-These regulations do not include government
laboratories doing laboratory examinations limited to
acid fast bacilli microscopy , malaria screening and
cervical cancer screening. provided their services are
declared as extension of a licensed government clinical
laboratory.
Section 5: Classification of Laboratories
1- Classification by Function
a. Clinical Pathology- includes Hematology, Clinical
Chemistry, Microbiology, Parasitology, Mycology,
Clinical Microscopy, Immunology and Serology,
Immunohematology, Toxicology and Therapeutic Drug
Monitoring and other similar disciplines.
b Anatomic Pathology- includes Surgical Pathology,
Immunohistopathology, Cytology, Autopsy and Forensic
Pathology.
2- Classification by Institutional Character
A. Hospital-based laboratory-a laboratory that operates
within a hospital
B. Non-hospital-based laboratory- a laboratory that
operates on its own
3- Classification by Service Capability
A. Primary- provides the minimum service capabilities
such as:
2. No clinical laboratory shall be constructed unless
plans have been approved and constraction permit issued
by the BHFS.
3. A clinical laboratory shall operate with a valid license
issued by BHFS/CHD, based on compliance with the
minimum licensing requirements (Annex A).
4. The clinical laboratory shall be organized and
managed to provide effective and efficient laboratory
services.
5. The clinical laboratory shall provide adequate and
appropriate safety practices for its personnel and
clientele
(1) Routine Hematology (Complete Blood Count or
CBC) - includes Hemoglobin Mass Concentration,
Erythrocyte Volume Fraction (Hematocrit), Leucocyte
Number Concentration (WBC count) and Leucocyte
Type Number Fraction (Differential Count). Qualitative
Platelet Determination
Section 7: Requirements and Procedures for Application
of Permit to Construct and License to Operate
(2) Routine Urinalysis
a. Letter of Application to the Director of BHFS
(3) Routine Fecalysis
B. Four (4) sets of Site Development Plans and Floor
Plans approved by an architect and/or engineer,
(4) Blood Typing - hospital-based
(5) Quantitative Platelet Determination - hospital-based
B. Secondary - provides the minimum service
capabilities of a primary category and the following
(1) Routine Clinical Chemistry- includes Blood Glucose
Substance Concentration Blood Urea Nitrogen
Concentration, Blood Uric Acid Substance
Concentration Blood Creatinine Concentration, Blood
Total Cholesterol Concentration
(2) Crossmatching
C. Tertiary - provides the secondary service capabilities
and the following:
(1) Special Chemistry
(2) Special Hematology
(3)Immunology /Serology
(4) Microbiology
1. Application for Permit to Construct
The following are the documents required:
c. DTI/SEC Registration (for private clinical laboratory)
2. Application for New License
A duly notarized application form "Petition to Establish,
Operate and Maintain a Clinical Laboratory, shall be
filed by the owner or his duly authorized representative
at the BHFS.
3.Application for Renewal of License
A duly notarized application form Application for
Renewal of License to Establish, Operate and Maintain a
Clinical Laboratory" shall be filed by the owner or his
duly authorized representative at the respective CIHD.
4. Permit and License Fees
a- A non-refundable license fee shall be charged for
application for permit to construct, and for license to
operate a government and private clinical laboratory.
b- A non-refundable fee shall be charged for application
for renewal of license to pune uo p operate.
Section 6: Policies
1. An approved permit to construct and design layout of
clinical laboratory shall be secured form the BHFS prior
to submission of an application for a Petition to Operate
c- All fees shall be paid to the Cashier of the BHFS /
CHD.
d. All fees shall follow the current prescribed schedule
of fees of the DOH.
5. Penalties
a. A penalty of one thousand pesos (P1,000.00) for late
renewal shall be charged in addition to the renewal fee
for all categories if the application is filed during the
next two (2) months after expiry date.
b. An application received more than two (2) months
after expiry date shall be fined one hundred pesos
(P100.00) for each month thereafter in addition to the
P1,000.00 penalty.
6. Inspection
a. Each license shall make available to the Director of
the BHFS / CHD or his duly authorized representative
(s) at any reasonable time, the premises and facilities
where the laboratory examinations are being performed
for inspection.
b. Each license shall make available to the Director of
the BHFS / CHD or his duly authorized representative
(s) all pertinent records.
c. Clinical laboratories shall be inspected every two (2)
years or as necessary.
7. Monitoring
a. All clinical laboratories shall be monitored regularly
and records shall be made available to determine
compliance with these rules and regulations
d. The laboratory in its new location shall be subject to
re-inspection and shall comply with the licensing
requirements.
e. An extension laboratory shall have a separate license.
f. Any change affecting the substantial conditions of the
license to operate a laboratory shall be reported within
15 days in writing by the person(s) concerned, to the
BHFS/ CHD for notation and approval. Failure to do so
will cause the revocation of the license of the clinical
laboratory.
g. The clinical laboratory license must be placed in a
conspicuous location/area within the laboratory
Section 8: Violations
1. The license to operate a clinical laboratory shall be
suspended or revoked by the Secretary of Health upon
violation of R.A. 4688s or the Rules and Regulations
issued in pursuance thereto.
2. The following acts committed by the Owner,
President, Managers, Board of Trustees Director,
Pathologist or its personnel are considered violations.
a-Operation of a clinical laboratory without a certified
pathologist or without registered medical technologist
b- Change of ownership, location, head of laboratory or
personnel without informing the BHFS and/or the CHD.
b. The Director of the BHFS/CHD or his authorized
representative(s) shall be allowed to monitor the clinical
laboratories shall be monitored regularly and records
shall be made to monitor the elinical laboratory at any
given time.
c- Refusal to allow inspection of the clinical laboratory
by the person(s) authorized by he BHFS during
reasonable hours
c. All clinical laboratories shall make available to the
Director of the BHFS or his duly authorized
representative(s) records for monitoring.
e- The Provincial, City and Municipal Health Officers
are authorized to report to the CHD and BHFS the
existence of unlicensed clinical laboratories or any
private party performing laboratory examinations
without proper license and/or violations to these rules
and regulations
8.Issuance of license
The license shall be issued by the Director of the CHD
or his authorized representative the application is found
to be meritorious.
9. Terms and Conditions of License
a The license is granted upon compliance with the
licensing requirements.
b. The license is non-transferable.
c. The owner or authorized representative of any clinical
laboratory desiring to transfer a licensed clinical
laboratory to another location shall inform the CHD in
writing at least 15 days before actual transfer.
d- Gross negligence
Section 9: Investigations of Charges or complaints
The BHFS/CHD or his duly authorized representative(s)
shall investigate the complaint and verity if the
laboratory concerned or any of its personnel is guilty of
the charges.
1- If upon investigation, any person is found violating
the provision of R.A. 4688, or any of these rules and
regulations, the BHFS/CHD or his duly authorized
representative(s) shall suspend, cancel or revoke for a
determined period of time the license, as well as the
authority’s the offending person (s) without prejudice to
taking the case to judicial penalty authority for criminal
action.
TECHNICAL STANDARDS AND MINIMUM
REQUIREMENTS
2-Any person who operates a clinical laboratory without
the proper license from the Department of Health shall
upon conviction be subject to imprisonment for not less
than 1 month but not more 1 year or a fine of not less
than P1,000.00 and not more than P5000.00 or both at
the discretion of the court. Provided, however, that if the
offender is a firm or corporation, the Managing Head
and/or owner/s thereof shall be liable to the e imposed
herein.
The clinical laboratory shall be organized to provide
effective and efficient laboratory services.
3. Any Clinical Laboratory operating without a valid
license or whose license has been revoked/cancelled
shall be summarily closed upon order issued by the
BHFS/CHD or his duly authorized representative. The
BHFS/CHD may seek the assistance of the law
enforcement agency to enforce the closure of any
clinical laboratory.
STAFFING
1. The clinical laboratory shall be managed by a licensed
physician certified ha Philippine Board of Pathology. In
areas where pathologists are not available, a physician
with three (3) months training on clinical laboratory
medicine, quality control and laboratory management,
may manage a primary/secondary category clinical
laboratory BHFS shall certify such training.
2. The clinical laboratory shall employ qualified and
adequately train personnel Work assignment shall be
consistent with the qualification of the concerned
personnel.
4-The closure order issued by the DOH shall not be
rendered ineffective by any restraining order and
injunction order issued by any court, tribunal or agency
or instrumentalities.
a. A clinical laboratory shall have sufficient number of
registered medical technologists proportional to the
workload and shall be available at all times during hours
of laboratory operations. For hospital-based clinical
laboratory. there shall be at least one registered medical
technologist per shift to cover the laboratory operation.
Section 10: Modifications and Revocation of License
3. There shall be staff development and appropriate
continuing education program available at all levels of
the organization to upgrade the knowledge, attitudes and
skills of staff.
1. A license maybe revoked, suspended or modified in
full or in statement by the applicant, or as shown by the
record of inspection or for a violation of, or failure to
comply with any of the terms and conditions and
provisions of these rules and regulations.
2. No license shall be modified, suspended or revoked
unless prior notice has been made and the corresponding
investigation conducted except in willful, or repeated
violations hereof, or where public health interest or
safety requires otherwise.
Section 11 : Repealing Clause
These rules and regulations shall supersede all other
previous official issuances hereof.
Section 12: Publication and List of Licensed Clinical
Laboratories
A list of licensed clinical laboratories shall be published
annually in a newspaper of circulation.
II. PHYSICAL FACILITIES
1. The clinical laboratory shall be well-ventilated,
adequately lighted, clean and safe.
2. The working space shall be sufficient to accommodate
its activities and allow for smooth and coordinated work
flow.
3. There shall be an adequate water supply.
4-The working space for all categories of clinical
laboratories (both hospital and non-hospital-based) shall
have at least the following measurements
Category
space in sq.m.
Primary
10
Section 13: Effectivity
Secondary
20
These rules and regulations shall take effect 15 days
after its publication in the Official Ganette, or in a
newspaper
general Standards
circulation.and Minimum
ANNEX
Requirements
A of
Technical
Tertiary
60
III.EQUIPMENT/INSTRUMENTS
1-There shall be provisions for sufficient number and
types of appropriate equipment/instruments in order to
undertake all the activities and laboratory examinations.
This equipment shall comply with safety requirements.
2- For other laboratory examinations being performed,
the appropriate equipment necessary for performing such
procedures shall be made available.
IV. GLASSWARES/REAGENTS/SUPPLIES
All categories of clinical laboratories shall provide
adequate and appropriate glassware, reagents and
supplies necessary to undertake the required services.
V. WASTE MANAGEMENT
There shall be provisions for adequate and efficient
disposal of waste following guidelines of the
Department of Health and the local government.
VI. QUALITY CONTROL PROGRAM
All clinical laboratories shall have a functional Quality
Assurance Program
Laboratory requests shall be construed as consultation
between the requesting physician and the Pathologist of
the laboratory and as such laboratory results shall
released accordingly.
1-All laboratory reports on various examinations of
specimens shall bear the name of the registered medical
technologist and the Pathologist and duly signed by
both.
2-No person in the clinical laboratory shall issue a
report, orally or in writing whole or portions thereof
without a directive from the Pathologist or his authorized
associate to the requesting physician or his authorized
representative except in emergency cases when the
results may be released as authorized by the Pathologist
VIII. RECORDING
There shall be a system of accurate recording to ensure
quality results.
1. Internal Quality Control Program
1. There shall be an adequate and effective system of
recording requests and reports of all specimens
submitted and examined.
A-There shall be a documented, continuous competency
assessment program for all laboratory personnel.
2. There shall be provisions for filing, storage and
accession of all reports.
B-The program shall provide appropriate and standard
laboratory methods, reagents and supplies and
equipment.
3. All laboratory records shall be kept on file for at least
one (1) year.
C. There shall be a program for the proper maintenance
and monitoring of all equipment.
a- Records of anatomic and forensic pathology shall
be kept permanently in the laboratory.
IX. LABORATORY FEES
D-The program shall provide for the use of quality
control reference materials.
laboratory and professional fees to be charged for
laboratory examination shall be at the prevailing rates.
2. External Quality Control Program
1. The rates shall be within the range of the usual fees
prevailing at the time and the particular place, taking
into consideration the cost of testing and quality control
of various laboratory procedures.
A-All clinical laboratories shall participate in an
External Quality Assurance Program given by
designated National Reference Laboratories and/or other
recognized reference laboratories.
B-A satisfactory performance rating given by a National
Reference Laboratory shall be one of the criteria for the
renewal of license.
2. Professional services rendered to the patient in the
performance of special procedures or examinations shall
be charged separately and not included in the laboratory
fee/s.
C. Any refusal to participate in an External Quality
Assurance Program given by the designated National
Reference Laboratories shall be one of the bases for
suspension.
A clinical laboratory is made up of different sections
cohesively and comprehensively performing different
activities and procedures for each specimen collected
from patients to produce reliable test results.
VII. REPORTING
Clinical Chemistry
This section is intended for the testing of blood and other
body fluids to quantify essential soluble chemicals
including Waste products useful for the diagnosis of
certain diseases. Blood and urine are the two most
common body fluids subjected for analyses in this
section. Examples of tests performed in this section are f
FBS, Hba1c, HDL and LDL,TAG, Bua, BUN etc.
Internal Quality Assurance , Continuous Quality
Improvement , and participation in National External
Quality Assurance Program are important activities that
medical technologists perform and are responsible for.
Microbiology
This section is subdivided into four sections:
bacteriology, mycobacteriology, mycology. and virology.
At present, the work in this section is more focused on
the identification of bacteria and fungi on specimens
received. Specimens usually submitted are blood and
other body fluids, stool, tissues, and swabs from
different sites in the body.
Hematology and Coagulation Studies
This section deals with the enumeration of cells in the
blood and other body fluids (e.g., r pleural fluid, etc.).
The examinations done in this section include complete
blood count ORC, hemoglobin, hematocrit, WBC
differential count, red cell morphology and cell indices,
antitative platelet count, total cell count and differential
count, blood smear preparation, d staining for other body
fluids. Coagulation studies focus on blood testing for the
determination of various coagulation factors.
Clinical Microscopy
There are two major areas in this section of the
laboratory. The first area is allotted to routine and other
special examinations of urine such as macroscopic
examinations to determine color, transparency, specific
gravity, and pH level, and microscopic examinations to
detect presence of abnormal cells and/or parasites as
well as to quantify red cells and WBC and other
chemicals found in urine. The second area is assigned to
the examination of stool or routine Fecalysis. Detection
and identification of parasitic worms and ova are the
primary activities in this area.
Blood Bank/Immunohematology
Blood typing and compatibility testing are the two main
activities performed in this section. Screening for all
antibodies and identification of antibodies as well as the
blood Components used for transfusion are also
conducted in this section. In hospital-based clinical
laboratories, blood donation activities prompt other
activities such as donor recruitment and screening,
bleeding of donor, and post-donation care.
Immunology and Serology
Analyses of serum antibodies in certain infectious agents
(primarily viral agents) are performed in this section.
Hepatitis B profile tests, serological tests for syphilis,
and tests for hepatitis C and dengue fever are some
examples of antibody screening tests. Similar to Clinical
Chemistry and Hematology sections, automated
analyzers are commonly used in this section when
performing different serological tests.
Anatomic Pathology
Section of Histopathology/Cytology
Activities performed in this section include tissue
(removed surgically as in biopy and autopsy) processing,
cutting into sections, staining, and preparation for
microscopic examination by a pathologist.
Specialized Sections of the Laboratory
Immunohistochemistry
Specialized Sections of the Laboratory
Immunohistochemistry
It is a specialized section of the laboratory that combines
anatomical, clinical, biochemical techniques where
antibodies (monoclonal and polyclonal) bounded to
enzymes and fluorescent dyes are used to detect
presence of antigens in tissue. This is useful in the
diagnosis of some types of cancers by detecting the
presence of tumor-specific antigens, oncogenes, and
tumor suppressor genes.
Molecular Biology and Biotechnology
One of the exciting developments in medical technology
is molecular biology and biotechnology diagnostics.
Primarily using different enzymes and other reagents,
DNA and RNA are identified and sequenced to detect
any pathologic conditions/disease processes The most
common technique currently in use is the polymerase
chain reaction (PCR).
Laboratory Testing Cycle
The laboratory testing cycle encompasses all activities
starting from a medical doctor writing a laboratory
request up to the time (called the turnaround time (TAT)
the results are generated and become useful information
for the treatment and management of patients This cycle
has three phases, namely, pre-analytic, analytic, and
post-analytic.
-The pre-analytic phase includes the receipt of the
laboratory request, patient preparation, specimen
collection and proper transport and processing of
specimen to the clinical laboratory.
-The analytic phase deals with the actual testing of the
submitted/collected specimen.
-The post-analytic phase includes the transmission of
test results to the medical dector for interpretation, TAT,
and application of doctor's recommendations.
Quality Assurance in the Clinical Laboratory
Quality assurance (QA) encompasses all activities
performed by laboratory personnel to ensure reliability
of test results.
Quality assurance in the clinical laboratory has two
major components: Internal Qualit Assurance System
(IQAS) and External Quality Assurance System
(EQAS), IQAS include day-to-day activities that are
undertaken in order to control factors or variables that
affect test results. Regular review and audit of results are
done in order to identify weakness and consequently
perform corrective actions, EQAS, on the other hand, is
a system fon checking performance among clinical
laboratories and is facilitated by designated external
agencies. The National Reference Laboratories (NRL) is
the DOH-designated EQAS.
At present, the designated NRL-EQAS are the
following:
• National Kidney and Transplant Institute – Hematology
and Coagulation
• Research Institute of Tropical Medicine - Microbiology
(identification and antibiotic susceptibility testing) and
Parasitology (identification of ova and quantitation of
malaria)
• Lung Center of the Philippines – Clinical Chemistry
(for testing 10 analytes, namely glucose, creatinine, total
protein, albumin, blood urea nitrogen, uric acid,
cholesterol, sodium, potassium, and chloride)
• East Avenue Medical Center - Drugs of abuse
(methatamine and cannabinoids)
• San Lazaro Hospital Cooperative Center Laboratory –
Infectious immunology hepatitis B surface antigen ,
human immunodeficiency virus , hepatitis C virus
Lesson 9: Professional Organizations
Professional organizations are assemblages of
professionals within a specialization or professional
field that come together for the purpose of
collaboration, networking, and professional
development or advancement. Officers and members
of professional organizations serve to promote the
particular professional field they are part of, to
educate the public on issues relevant to the industry.
In the Philippines, membership to an accredited
professional organization (APO) or accredited
integrated professional organization (AIPO) is a
requirement for hiring, retention, and sometimes for
the renewal of professional licenses. An APO or AIPO
is a professional society duly accredited by the
Professional Regulation Commission (PRC) and the
respective Professional Regulatory Board (PRB).
The Philippine Association of Medical Technologists,
Inc. (PAMET) is the accredited professional
organization and the leading national organization
for Registered Medical Technologists in the country.
The Philippine Association of Schools of Medical
Technology and Public Health, Inc. (PASMETH) is
the only professional organization of schools for
Medical Technology/Medical Laboratory Science.
Benefits of Membership in Professional
Organizations
Professionalism: adhere to the set of rules or code of
ethics prescribed by the professional society.
Education: Professional organizations organize
continuing professional development (CPD) activities
for their members through conventions, seminars, fora,
workshops, and other activities of similar nature.
Perks: Perks usually come in the form of monetary
discounts on registration fees for professional
development activities of the organization. These
discounts are offered exclusively to members of the
organization.
Networking: Activities conducted by professional
organizations provide opportunities for building
networks in the field. Gatherings and other activities can
be potential avenues for creating long-term linkages and
connections with other professionals in the field.
Profile: Membership in a professional organization can
also build the career portfolio of a professional. A
professional society can also provide opportunities for
speaking engagements, career specialization, publication
in research journals and even scholarship and training
programs .
Recognition: Professional organizations recognize their
outstanding members and leaders in the practice and
special fields such as research, public service, and
community engagements through awards. This helps
enhance one's professional profile.
Types of Professional Organizations
Professional organizations are classified based on their
main function.
Accrediting Organizations: Accrediting organizations
accredit curricular programs in educational institutions,
An educational institution applying for accreditation will
then be visited by a technical committee of experts from
the accrediting agency to verify its compliance to the
standards of quality education.
Example of International Professional Societies for
Medical Technologists
Examples of Local Accrediting Organizations for
Medical Technology Schools
Credentialing/Certifying Organizations:
Credentialing or certifying organizations provide
certification examinations for professionals to renew
their licenses within a specified duration.
Examples of International Credentialing/Certifying
Agencies for Medical
Professional Journals
Professional journals are publications containing
scholarly studies on specific professional fields.
Compared to other types of publications ,professional
journals are normally prepared by professionals in the
field and are peer-reviewed by experts.
Some of the available professional journals for
laboratory professionals are:
Philippine Journal of Medical Technology
Asia-Pacific Journal of Medical Laboratory Science
International Journal of Science and Clinical Laboratory
Laboratory Medicine
Professional Societies: are organization that contribute
to the continued development of a specific group of
professionals.
Examples of Local Professional Societies for Medical
Technology
Medical Laboratory Observer
Clinical Laboratory Science
Advances for Medical Laboratory Professionals
PAMET
The Philippine Association of Medical Technologists,
Inc. (PAMET) is the national professional organization
of Registered Medical Technologists in the Philippines.
The organization was founded on September 15, 1963
through the initiative of Crisanto G. Almario, considered
as the "Father of PAMET at the Public Health
Laboratory in Quiricada St., Sta. Cruz, Manila.
Professionalism: Professionalism refers to the positive
traits and values, moral responsibility, social
responsiveness, and behavioral outlook which makes
one highly respectable and credible.
It organized its first national convention and election of
officers on September 20, 1964 at the Far Eastern
University.
Commitment: Commitment is the unconditional,
unwavering, and selfless dedication that one builds-in
into the practice of the profession characterized by
initiative, creativity, and resourcefulness to bring about
quality health care and service to the public.
Charlemagne T.Tamondong became the first president.
It was during the presidency of Nardito D. Moraleta that
PAMET was incorporated and registered at the
Securities and Exchange Commission (SEC) on October
14, 1969 with Registration No. 39570.
The First Organizational Meeting
The first organizational meeting of PAMET was held on
September 15, 1963 at the Public Health Laboratory in
Sta. Cruz, Manila.
A total of 20 representatives attended the organizational
meeting, 11 from allied medical professions and nine
from five schools offering medical technology.
PAMET Insignia
Excellence: Excellence is the high quality performance
by advocating and adhering to international standards
making services globally comparable and competent.
Unity: Unity is the necessary linkage, support,
involvement and sharing that will increase the success
and advancement of every individual member and the
association in general.
PASMETH
The Philippine Association of Schools of Medical
Technology and Public Health, Inc.
(PASMETH) is the national organization of
recognized schools of medical technology and public
health in the Philippines.
It was established in 1970 with the hopes of
maintaining the highest standards of medical
technology/public health education and fostering
closer relations among Medical Technology/Public
Health schools.
Circle -symbolizes the continuous involvement where
practice and education must always be integrated
PASMETH Seal
Triangle -the trilogy of love, respect, and integrity
Microscope and Snake -symbolize the science of
Medical Technology profession
Green -the color of health
1964 -the year the first PAMET Board was elected
Core Values
Integrity: Integrity is the strict adherence to a moral
code, reflected in transparent honesty truthfulness,
accuracy, accountability for one's actions, and complete
harmony in what one thinks, says, and does.
Circle - represents the continuity of learning and the
never- ending quest for excellence in the academic field
Diamond- the four corners represent the four objectives
of the Association:
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 Medical
Technology and Public Health education in order that the
profession will be of maximum service to the country
To take a united stand on matters which affect the
interests of Medical Technology and Public Health
education
to seek the advice, aid, and assistance from any
government or private entity for the fulfilment of the
association's aims and purposes.
c. Microscope -represents the field of Medical
Technology and Public Health
3 Circles -symbolize the continuous active involvement
of Luzon, Visayas, and Mindanao in the national
transforming venue of medical laboratory science
students
Laurel - symbolizes nature and the continuation of life
every year
Green Letters - represent the color of health
5 Bubbles from a Test Tube - represent the 5 objectives
embodied in the constitution of the organization
15 Interconnected Molecules Outside a Test Tube signify the unity of the 15 board schools exploring
various possibilities and aiming towards the integral
growth and holistic development of medical laboratory
science students
Microscope - represents medical laboratory science
d. 1970 -the year the Association was founded
Foreign Professional Societies
PHISMETS
The Philippine Society of Medical Technology Students
(PHISMETS) is the national organization of all medical
technology/medical laboratory Science students under
the supervision of PASMETH.
It was first organized in 2002 during the leadership of
former PASMETH president, Dr. Zenaida C. Cajucom.
Professional societies for medical technologists exist
around the world. Foreign and local laboratory
professional societies for medical technologists have the
same goals-to elevate the practice of medical
technology/medical laboratory science and safeguard the
welfare of their members. But each professional society
has roles and functions unique to itself.
The first PHISMETS advisers were Prof. Marilyn Bala
(CHS), Prof. Nova Aida C. Cajucom (FEU-NRMF) and
Prof. Zennie B. Aceron (UST).
The organization became inactive due to inevitable
reasons, but was reorganized on November 25, 2006 at
FEU-NRMF headed by Dir. Magdalena Natividad then
Chair of the Committee on Student Development, and
Dean Bernard Ebuen.
Lesson 10: Continuing professional development
(CPD)
Lifelong Learning for Professional
Most people associate learning with formal education.
Aspiring professionals view the attainment of quality
education as a very important goal.
Learning happens through the course of a lifetime. It
does not stop once graduation and togas are donned and
diplomas are conferred.
Professionals should be lifelong learners. They are
expected to have skills that are on a par with the
requirements of companies to ensure the quality of
services they will render.
In the health care industry, for example, research
suggests that higher level of education among health
care providers leads to better health care delivery and
improved patient outcomes.
CPD is embraced by developing countries as an effective
way of maintaining and improving the competencies of
health professionals, thus, making it mandatory.
Lifelong learning is a demand in an environment filled
with global markets. Previously, professional practice
used to be confined within a nation's borders but because
of globalization, there is accelerated change and
application of technology solutions in the new
millennium. Professional mobility across international
borders is now common. Global market players and
employers prefer employees who continually acquire
skills and knowledge to enable them to adapt to the
evolving needs of the global labor market. This is
important in the context of the Filipino nation because of
its huge sector of overseas foreign workers (OFW) with
thousands of professionals being employed in other
countries annually.
The terms CPD (Continuing Professional Development),
and CPE (Continuing Professional Education) are often
used interchangeably.
The establishment of the ASEAN Economic
Community (AEC) in 2015 was a historical milestone
and a huge stride towards the regional economic
integration of ASEAN Member States (AMS). As a step
towards regional integration and mobility of
professionals in the region, the ASEAN Qualifications
Reference Framework (AQRF) was established. The
AQRF is a common reference framework that enables
comparison of educational qualifications across AMS.
One of the objectives of the AQRF is to encourage the
development of qualifications that can facilitate lifelong
learning.
Continuing Professional
Continuing Professional Development (CPD) is
important to ensure the competency of Professionals. It
is the maintenance, enhancement, and extension of
knowledge, expertise, and competence of professionals
after attaining a bachelor's degree.
It provides a structured framework to ensure
improvement, progression, and career growth that
benefits both professionals and their respective
organizations.
The Benefits of CPD
CPE more aptly refers to training which is linear and
formal. Training objectives in CPE are usually focused
on learning a particular skill or set of skills to improve
professional competence.
CPD, on the other hand refers to the development of
one's knowledge, skills, and attitude significantly
relevant to capability and competency in his or her
profession.
R.A. 10912 defines lifelong learning as "learning
activities undertaken throughout life for the development
of competencies and qualifications of the professional.
CPD was defined as "the inculcation of advanced
knowledge, skills, and ethical values in a post-licensure
specialization or in an inter - or multidisciplinary field
of study, for assimilation into professional practice, selfdirected research, and / or lifelong learning. "
The said law seeks to formulate and implement CPD
programs for each profession in order to:
1. Enhance and upgrade the competencies and
qualifications of professionals for the practice of their
professions pursuant to the Philippine Qualifications
Framework (PQF), the AQRF, and the ASEAN Mutual
Recognition Agreements (MRAs)
2. Ensure international alignment of competencies and
qualifications of professionals through career
progression mechanisms leading to specialization / subspecialization
3. Ensure the development of quality-assured
mechanisms for the validation, accreditation, and
recognition of formal, non-formal, and informal learning
outcomes, including professional work experiences and
prior learning
4. Ensure maintenance of core competencies and
development of advanced and new competencies, in
order to respond to national, regional, and international
labor market need.
5. Recognize and ensure the contributions of
professionals in uplifting the general welfare, economic
growth, and development of the nation.
According to PRC, the overarching goal of CPD
programs is the promotion of the general welfare and
interests of the public in the course of delivering
professional services. Further, CPD aims to:
continuously improve the quality of the country's
reservoir of registered professionals by updating them on
the latest scientific/technological/ethical and other
applicable trends in the local and global practice of the
professions
provide support to lifelong learning in the enhancement
of competencies of Filipino professionals towards
delivery of quality and ethical services both locally and
globally
deliver quality CPD activities aligned with the
Philippine Qualifications Framework (PQF) for national
and global comparability and competitiveness.
The CPD process
Each profession has its own CPD council which is
composed of:
A member from the Professional Regulatory Board
(PRB) as chair,
The president or officer of an Accredited Professional
Organization (APO) as first member.
The president or officer of the national organization of
deans or department chairpersons of schools, colleges, or
universities offering the course requiring the licensure
examination as second member.
In the case of the medical technology profession, the
first member is the president of the Philippine
Association of Medical Technologists, Inc. (PAMET)
The second member is the president of the Philippine
Association of Schools of Medical Technology and
Public Health, Inc. (PASMETH).
The current list of CPD providers for medical
technologists is as follows:
1. Philippine Association of Medical Technologists, Inc.
(PAMET).
2. Philippine Association of Schools of Medical
Technology and Public Health, Inc. (PASMETH).
3. Research Institute for Tropical Medicine (RITM).
4. Philippine Blood Coordinating Council (PBCC).
5. Philippine Council for Quality Assurance in Clinical
Laboratories.
6.National Reference Laboratory for HIV/AIDS and
other Sexually Transmitted Diseases, San Lazaro
Hospital ( NRL-SLH/SACCL).
7.University of Santo Tomas Faculty of PharmacyDepartment of Medical Technology.
Health Care Waste
All solid or liquid waste generated by any of the
following activities:
Diagnosis, Treatment and Immunizations of humans;
Research Pertaining to diagnosis, treatment and
immunization of humans;
Research using laboratory animals geared towards
improvement of human health;
Production and testing of biological products;
Other activities performed by a health care facility that
generates waste
Categories of Health Care Waste
Infectious waste
Pathological and Anatomical waste
Sharps
Chemical Waste
Pharmaceutical Waste
Radioactive Waste
Non-Hazardous or General Wast
Categories of Health Care Wastes
Infectious Waste
All waste suspected to contain pathogens or toxins that
may cause disease to susceptible host and also includes
discarded materials or equipment used for diagnosis,
treatment and management of patient with infectious
diseases
Example:
Discarded microbial cultures
Solid waste with infections ( dressings, sputum cups,
urine containers and blood bags)
Liquid wastes with infection ( blood, urine, vomitus and
other body secretions
Food wastes (liquid or solid) coming from patients with
highly infectious diseases
Pathological and Anatomical Waste
Refers to tissue sections and body fluids or organs
derived from biopsies, autopsies or surgical procedures
sent to the laboratory for examination
Anatomical waste is a subgroup of pathological waste
that refers to recognizable body parts usually from
amputation procedures
Example
Internal organs and tissues used for histopathological
examination
Sharps
Refers to waste items that can cause cuts, pricks or
puncture wounds
Considered most dangerous health care waste cause
both injury and infection
Examples:
Syringes in phlebotomy
Blood lancets
Surgical knives
Broken glasswares
Chemical Waste
Refers to discarded chemical(solid, liquid or gaseous)
generated during disinfection and sterilization
procedures and also includes waste with high content of
heavy metals and their derivatives
Example:
Laboratory Reagents
X-ray film developing solutions
Disinfectants and Soaking Solutions
Used batteries
Conc. Ammonia solutions
Conc. Hydrogen Peroxide
Chlorine
Mercury from broken thermometers and
sphygmomanometer
Chemicals are considered hazardous when they are:
Toxic ( with health and environmental hazards)
Corrosive ( Acid of pH < 2.0 and bases of pH >12.0)
Flammable (with a flash point below 60°C)
Reactive (explosive with water)
Common Chemical Waste in Health Care Facilities
Pharmaceutical Waste
Refers to expired, spilt, and contaminated
pharmaceutical products, drugs, vaccines including
discarded items used in handling pharmaceuticals.
Includes antineoplastic, cytotoxic and genotoxic waste (
drugs used in oncology or radiotherapy and biological
fluids from patients treated with the said drugs
Examples:
Empty drug vials
Medicine bottles containers of cytotoxic drugs
(including materials used in preparation and
administration)
Radioactive Waste
Refers to waste exposed to radionuclides including
radioactive diagnostic materials or radiotherapeutic
materials
Examples
Cobalt (Co 90)
Technetium (99 Tc)
Iodine ( 131 I)
Iridium ( 192 Ir)
Irradiated blood products
All materials used by patients exposed to radionuclides
within 48 hrs
Non- Hazardous or General Waste
Refers to waste that have not been in contact with
communicable or infectious agents, hazardous chemicals
or radioactive substances and do not pose a hazard
Further classified: Recyclable Waste, Biodegradable
waste and Non-recyclable/ non-biodegradable waste
Examples:
Plastic bottles
Used paper products
Office waste
Scrap wood
Food waste from non-infectious patients
Legislation, Policies, and Guidelines Governing
Health Care Waste
International Agreements Pertaining to Health Care
Waste Management
The Montreal Protocol on Substances that Deplete
the Ozone Layer (1987)
Adopted in Montreal, Canada on September 16, 1987
and came into force as agreed upon January 1, 1989
Sets the final objective of the protocol to eliminate
ozone depleting substances in the environment
The Basel Convention on the Control of the
transboundary movements of Hazardous waste and
their disposal (1989)
Concerned with the transboundary movements of
hazardous waste
Countries that signed the Convention accepted the
principle that only legitimate transboundary shipments
of hazardous waste are exported from countries that lack
the facilities or expertise to safely dispose certain waste
to other countries that have both facilities and expertise
The United Nations Framework Convention on
Climate Change (1992)
Legally non-binding pledge that by the year 2000, major
industrialized nations would voluntarily reduce their
greenhouse gas emissions to 1990 levels
The Stockholm convention on persistent organic
pollutants (2001)
Global treaty to protect human health and the
environment from persistent organic pollutants (POPs)
POPs are chemicals that:
Remain unchanged in the environment for long periods
of time
Accumulate in the fatty tissues of living organisms
Toxic to both human and wildlife
The ASEAN Framework Agreement on the
Facilitation of Goods in Transit (1998)
A core instrument that provides nine high level protocols
that set out generic standards to be put into a place for
the implementation of an international transit system
Specifically, the framework agreement includes Protocol
9 on Dangerous Goods which provides provisions on the
transport of toxic and infectious substances
Class 1 - Explosives
Class 2 - Gases
Class 3 - Flammable Liquids
Class 4 - Flammable Solids
Class 5 - Oxidizing Substances and Organic Peroxides
Class 6 - Toxic and Infectious Substances
Class 7 - Radioactive Material
Class 8 - Corrosives
Class 9 - Miscellaneous Dangerous Goods
National Laws and Policies on Health Care Waste
Management
Republic Act No. 4226 “Hospital Licensure Act”
(1965)
An act that requires the registration and licensure of all
hospitals in the country and mandates the DOH to
provide guidelines for hospital technical standards as to
personnel, equipment and physical facilities
DOH Administrative Order No. 70- Series of 2002 “
Revised Rules and Regulations Governing the
Registration, Licensure and Operation of Hospitals
and Other Health Facilities in the Philippines
Includes application or renewal of license, submission of
plans and other design requirements under the: Code of
Sanitation of the Philippines, National Plumbing Code of
the Philippines, Revised Fire Code of the Philippines
and National Building Code of the Philippines
The Manuals on Hospital Waste Management and Health
Facilities Maintenance are also required for submission
for verification by the DOH- Bureau of Health Facilities
and Services (BHFS)
DOH Administrative Order No. 2005-0029 dated
December 12,2005 “Amendment to A.O. No. 70 series
of 2002 re: Revised Rules and Regulations Governing
the Registration, Licensure and Operation of
Hospitals and other Health Facilities in the
Philippines
Requires HCF to submit a health care waste
management Plan to BHFS as one of its requirements for
the issuance of license to operate
DOH Administrative Order No. 2007-0026 dated
August 22, 2007 “ Revised Rules and Regulations
Governing the Licensure and Regulation of Clinical
Laboratories in the Philippines”
Requires written procedures for the proper disposal of
health care waste and other hazardous substances and
required written policy guidelines on biosafety and
biosecurity
Republic Act No. 6969 “An Act to Control Substances
and Hazardous and Nuclear Waste” (1990)
Requires the registration of waste generators, waste
transporters and operators of toxic and hazardous waste
facilities with the EMB
The waste generators are required to ensure that their
hazardous wastes are properly collected, transported,
treated
disposed
in aOrder
sanitary
landfill
DENR
“Revising
2002,
toand
Administrative
Further
DENR
Prescribing
Strengthen
Administrative
thethe
No.
Use
Implementation
Order
36of the
Series
29-Series
Procedural
of 2004
of
of
R.A
Manual”
6969
and
DENR Administrative Order No. 36- Series of 2004
“Revising DENR Administrative Order 29-Series of
2002, to Further Strengthen the Implementation of
R.A 6969 and Prescribing the Use of the Procedural
Manual
Procedural Manual requires a comprehensive
documentation on the legal and technical requirements
of hazardous waste management
The Manual does not include provisions regarding the
management of nuclear waste and composed of ten
sections that discuss:
Classification of hazardous wastes
Waste generators
Waste Transporters
(Continuation )
Storage and labelling
Treatment, Storage and Disposal (TSD) Facilities
Manifest system
Monitoring
Prohibited Acts
Schedule of fees
Import of recyclable materials containing hazardous
substances and export of hazardous waste
DOH- DENR Joint Administrative Order No. 02
series of 2005 dated August 24, 2005 “ Policies and
Guidelines on Effective and Proper Handling,
Collection, Transport, Treatment, Storage and
Disposal of HCW”
Aims to:
Provide guidelines to generators, transporters, and
operators/owners of TSD Facilities on the proper
handling, collection, transport, storage, treatment and
disposal of Health Care Wastes (HCW)
Clarify jurisdiction, authority and responsibility of
DENR and DOH regard to health care waste
management (HCWM)
Harmonize the efforts of DENR and DOH on HCWM
DOH Administrative Order 2007-0014 “ Guidelines
on the Issuance of Certificate of Product Registration
for Equipment or Devices Used for Treating Sharps,
Pathological and Infectious Waste”
Requires the manufacturers, importers, and distributors
including generators of HCW that sell and/or use
equipment and devices treating sharps, pathological and
infectious waste to secure a Certificate of Product
Registration (CPR) from DOH through the Bureau of
Health Devices and Technology
Republic Act No. 8749 “ The Philippine Clean Air Act
of 1999)
Prohibits the incineration of bio-medical waste effective
July 17, 2003
Promotes the use of state-of-the-art, environmentallysound and safe non-burn technologies for handling,
thermal destruction, utilization and disposal of sorted,
unrecycled, biomedical and hazardous wastes
Republic Act No. 9003 “Ecological Solid Waste
Management Act of 2000”
Mandates the segregation of solid wastes at the sources
including households and institutions like hospitals by
using a separate container for each type of waste
Republic Act No. 9275 “ The Philippine Clean Water
Act of 2004”
Pursues a policy of economic growth in a manner
consistent with the protection, preservation and revival
of the quality of the country’s fresh, brackish and marine
waters
Presidential Decree 813 (1975) and Executive Order
927 (1983) “ Strengthening the Functions of Laguna
Lake Development Authority (LLDA)”
Further strengthens the power and functions of LLDA to
include environmental protection and jurisdiction over
surface waters of the Laguna Lake basin
Through E.O 927, LLDA is empowered to issue permits
for the use of the surface waters within Laguna de Bay
Presidential Decree 856 “ The Code on Sanitation of
the Philippines- Chapter XVII on Sewage Collection
and Excreta Disposal” (1998)
Requires the approval of DOH in term of the following:
Constructions of any type of toilet in every house and
community which may be allowed for a group of small
houses of light material or temporary in nature
Plans of individual sewage or sewage system and the
sub-surface absorption system or other treatment
Location of any toilet or sewage disposal system in
relation to a source of water supply
Requires the approval of DOH in term of the following:
(Continuation..)
Discharge of untreated effluent from septic tanks and/or
sewage treatment plants to bodies of water
Manufacture of Septic Tanks
Method of disposal of sludge from septic tanks or other
treatment plants
Rules and Regulations Governing the Collection,
Handling, Treatment and Disposal of Domestic
Sludge and Septage (2004), a “Supplement to IRR of
the Chapter XVII on Sewage Collection and Disposal
and Excreta Disposal and Drainage of 1998”
Require individuals, firms, public and private operators,
owners and administrators engaged in desludging,
collection , handling and transport, treatment and
disposal of domestic sewage treatment plants/ facilities
and septage from house septic tanks to secure
environmental sanitation clearances from DOH
Chapter XVIII of P.D 856 “ The Code of Sanitation
of the Philippines” on Refuse Disposal (1998)
Require cities and municipalities to provide an adequate
and efficient system of collecting, transporting and
disposing refuse in their areas of jurisdiction
Also require occupants of buildings, institution such as
hospitals and residences to provide sufficient number of
receptacles for refuse
Operation Manual on the Rules and Regulations
Governing Domestic Sludge and Septage (June 2008)
Provides detailed procedures and forms which need to
comply with the IRR governing the collection, handling,
transport, treatment, and disposal of domestic sludge and
septage
Designed to guide private and public service providers
as well as government regulators towards effective
sludge and septage management program in the country
A.O 2010-0033 “Revised Implementing Rules and
Regulations of P.D 856 Code on Sanitation of the
Philippines, Chapter XXI on Disposal of Dead
Persons” (December 2010)
Implemented a new restriction on open viewing of
remains when the individual’s death was caused by
certain communicable disease
Explicitly States, “The remains shall be placed in a
plastic cadaver bag or other durable airtight container at
the point of death and a biohazard tag attached, provided
that, this container shall not be opened for viewing or
any other purpose prior to burial or cremation
Presidential Decree 984 “ Providing for the Revision
of R.A 3931, Commonly known as the Pollution
Control Law and for Other Purposes” (1976)
Governs the discharge of potentially polluting
substances to air and water
Provides basis for the DENR regulations on water
pollution through its IRR, DENR A.O Nos 34 and 35
The IRR for air emission was initially set by DENR A.O
No 14 but was later replaced by Clean Air Act of 1999
(R.A 8749)
DENR Administrative Order No. 34 series of 1990
“Revised Water Usage and Classification/ Water
Quality Criteria Amending Sections No. 68 and 69,
Chapter III of the 1978 National Pollution Control
Commission (NPC now EMB) Rules and
Regulations”
Classified bodied of water according to their designated
uses and did not preclude use of the bodies of water for
other purposes that are lower than the classification
provided that such use does not prejudice quality
required for such waters
DENR Administrative Order No. 35 series of 1990 “
Effluent Regulations”
Lists their effluent regulations for the different levels of
pollutants according to their water category/class
DENR Administrative Order No. 26 series of 1992
“Amending Memorandum Circular No. 2 series of
1981: Appointment/ Designation of Pollution Control
Officers”
Requires the appointment/ designation of a Pollution
Control Officer (PCO) and lists the qualifications,
reporting requirements and duties and responsibilities of
accredited PCOs.
Presidential Decree No. 1586 “Environmental
Impact Statement (EIS) System” (1978)
Requires projects like construction of new hospital
building or expansion of existing hospitals to secure an
Environmental Compliance Commitment (formerly
Environmental Compliance) Certificate (ECC) prior to
the construction and operation of the facility
An ECC is required for the installation and operation of
HCW treatment like pyrolysis, autoclave, microwave
and other treatment technology including landfills
Executive Order No. 301 “Establishing a Green
Procurement Program for All Departments, Bureaus,
Offices and Agencies of the Executive Branch of
Government” (2004)
Aims to provide:
Promote the culture of making environmentally
informed decisions in the government especially in the
purchase and use of different products
Include environmental criteria in public tenders
whenever possible and practicable
Establish the specifications and requirements for
products or services to be considered environmentally
advantageous
Develop incentive programs for suppliers of
environmentally advantageous products or services
DOH Administrative Order No. 2008-0021 dated
July 30, 2008 “Gradual Phaseout of Mercury in all
Philippine Health Care Facilities and Institutions”
Requires all HCF to gradually phaseout the use of
mercury-containing devices and equipment
Initial targets of the phaseout are mercury thermometers
and sphygmomanometers in HCF
Department Memorandum No. 2011-0145 “
Guidelines for Temporary Storage of Mercury Waste
in HCF in Accordance with AO No. 0021 s.2008 on
the Gradual Phaseout of Mercury in All Philippine
Health Care Facilities and Institutions”
Provides the detailed guidelines on the temporary
storage of mercury-containing devices and the
management of mercury spills to enhance patient safety
measures in HCF, to protect health care workers from
potential hazards from mercury exposures and to
minimize the accumulation of mercury in the
environment
recycling of used pharmaceutical bottles and vials
Contain guidelines on the proper inventory and
destruction of bottles and vials
Health Care Waste Management System
DOH Administrative Order No. 2008-0023 dated
July 30, 2008 “National Policy on Patient Safety”
Requires the establishment and maintenance of a culture
of patient safety in HCF as the responsibility of its leader
HCF shall ensure that an enabling mechanism/ strategy
is in place to ensure patient safety
The key priority areas in patient safety include ( but not
limited to):
Proper patient identification
Assurance of blood safety
Safe clinical and surgical procedures
Provision and maintenance of safe quality drugs and
technology
Strengthening infection control standards
Maintenance of the environment of care standards
Energy and waste management standards
Safely reusing, recycling and recovering wastes are
collectively termed as Resource Development
Reusing- refers to either finding a new application for a
used material or using the same product for the same
application repeatedly however, safety and efficiency
should be considered when using medical items and
devices
Recycling- refers to the processing of used materials
into new products
Recovery- defined in two ways: 1. energy, recovery
whereby waste is converted to fuel for generating
electricity or for direct heating of premises and 2. as
term used to encompass three subsets of waste recovery:
recycling, composting and energy recovery
DOH “ Manual on Health Care Waste Management”
in 2011 (Revising the 2007 Health Care Waste
Management Manual)
Serves as a reference for HCF administrators in the
implementation of an effective and efficient waste
management program
The requirement for doing such are provided in the
manual by listing the standards of performance, defining
the mandatory requirements, providing new concepts
and citing examples and tools
The manual is designed to be used by all workers within
the HCF
PhilHealth Benchbook for Quality Assurance in
Health Care (2006)
Includes health care waste management as one of its
parameters in quality assurance of healthcare
BFAD Memorandum Circular No. s1994 “ Inventory,
Proper Disposal and/or Destruction of Vials or
Bottles” and BFAD Bureau Circular No 16, s1999
“Ammending BFAD MC No. 22 dated September 8,
1994, Regarding Inventory, Proper Disposal and/or
Destruction of Vials or Bottles
Released to prevent the proliferation of adulterated,
misbranded, and counterfeit drugs brought about by
Most Important Step: Waste Minimization using an
approach known as Green Procurement Policy
Green Procurement Policy involves 2 aspects:
Waste prevention
Waste reduction
For waste that cannot be safely reused, recycled or
recovered, the end of pipe approach is implemented
End of Pipe approach involves 2 aspects:
Waste Treatment- process of changing the biological
and chemical characteristics of waste to minimize its
potential to cause harm
Waste Disposal- refers to discharging, depositing, or
releasing any health care waste into air, land or water.
Not all type of wastes require treatment
Segregation, Collection, Storage and Transport of
Health Care Wastes
HCF are tasked to ensure that generated wastes are
properly and safely managed
HCW must be segregated, collected, stored and
transported while considering risk and occupational
safety and compliance with existing laws, policies and
guidelines
Segregation- process of separating different types of
waste at the point of generation until their final disposal
Color coding- to make it easier for personnel in a HCF
to put waste in correct bins and maintain segregation
during collection, storage, transport, treatment and
disposal
In the implementation of a color-coding system for
HCW, the following practices should be observed:
Highly infectious waste must be disinfected at source
Anatomical Waste including recognizable body parts,
placenta waste and organs should be disposed through
safe burial or cremation
Pathological waste must be refrigerated if not collected
or treated within 24 hours
Sharps must be shredded or crushed before they are
transported to the landfill
Chemical and pharmaceutical wastes shall be segregated
and collected separately
Radioactive waste has to be decayed to background
radiation levels
All waste bins must be properly covered to prevent cross
contamination
Aerosol containers can be collected with the general
waste
Treatment and Disposal of Health Care Waste
Proper Waste Treatment to ensure that HCW do not
pose harm to people and environment
HCW can be decontaminated either by sterilization and
disinfection
Chemical disinfection- chemical like sodium
hypochlorite, hydrogen peroxide, peroxyactetic acid and
heated alkali are added to HCW to kill or inactivate
present pathogens ( generates chemical wastes from used
chemical disinfectants)
Methods Used in Treatment of HCW
Biological Process- uses enzyme mixture to
decontaminate
Encapsulation- involves the filling of containers with
waste, adding and immobilizing material and sealing the
containers
Inertization- suitable for pharmaceutical waste that
involves the mixing of waste with cement and other
substances before disposal
After treatment, HCW are usually disposed in landfills.
Landfills is an engineered site designed to keep waste
isolated from environment
LESSON 12 BLOOD DONOR PHLEBOTOMY
LEARNING OUTCOMES
INFORMATION SHEET 12.0 Blood donation is the
collection, testing, preparation, and storage of blood
from donors who are usually volunteers. This activity
ensures the steady supply of blood for patients needing
surgery, those who are suffering from certain diseases,
and those who have been victims of accidents. The
donation could be for the benefit of a particular person
(directed donor blood) or it may also be autologous
blood donation, which means the donation is for the
benefit of the donor himself/herself who will use the
same during his/her scheduled surgery. Venipuncture for
blood donation is part of the entire process of handling
blood collection from donors. Although it is very similar
to blood sampling, additional measures such as donor
screening and deferral should be undertaken to ensure
the safety of the blood supply and prevent infections or
contaminations that can be transmitted through infected
blood donation.
Pyrolysis- thermal decomposition of HCW in the
absence of supplied molecular oxygen in the destruction
chamber where waste is converted to gaseous, liquid or
solid form.
The Goals of Performing Blood Donor Phlebotomy A
well-trained and qualified phlebotomist is the best
service personnel to perform the venipuncture for blood
donation. He/She must follow the rules in screening
blood donors to be able to accomplish the following
goals: (1) ensure the safety of the donors, (2) minimize
and prevent contamination in the donated blood which
may come from external sources, (3) conduct safe
collection of donated blood for therapeutic purposes
especially during its shelf life, and (4) make sure That
other personnel are well trained and qualified to do the
venipuncture procedure for blood donation.
Autoclave- use of steam sterilization using pressure and
heat ( 121°C in 15 psi for 15 to 30 mins)
The Blood Donation Process
Microwave- typically incorporates type of size
reduction device (100°C or 237°F for at least 30
minutes)
Blood donation usually takes 45 to 60 minutes and it is a
safe, simple, and rewarding procedure. Donors should at
least be 16 years old weighing 110 pounds at the
Sterilization kills all microorganism while Disinfection
reduces the level of microorganisms present in the
material
Methods Used in Treatment of HCW
minimum and should be generally healthy. The
following diagram illustrates the general process of
blood donation.
• Donor Screening - the donor is asked about his/her
health, lifestyle, and disease risk factors. All the details
provided are confidential.
• Donor Registration - the donor needs to complete a
donor registration form which includes his/her name,
address, and other demographic information.
• Medical History - the donor will have to confirm if
he/she has any health issues and disease risk factors.
•Donor Interview - the donor will have a brief interview
with the healthcare personnel to ensure that the donor
has met the general donor requirements.
• Physical Examination - a short health exam (pulse,
temperature, and blood pressure) will be conducted and a
drop of blood from the donor's finger will be tested to
ensure that his/her blood iron level is suitable for
donation.
•Guidance on Venipuncture for Blood Donation - a short
briefing on the procedure will be given by the health
personnel.
• Preparing the Venipuncture Site - the donor will be led
to the donor area where the arm is cleaned with
antiseptic and the vein for venipuncture is selected.
•Collecting the Unit - the unit of blood will be collected
by the health personnel. The blood donation kit will be
used to draw blood from the vein in the donor's arm. One
unit of blood donated takes about six to ten minutes to
complete.
• Adverse Events in Blood Donation - the healthcare
personnel will have to monitor the donor for adverse
effects during and after the blood collection. The donor
should remain seated for a few minutes before leaving
the room to ensure that he/she is not suffering from
dizziness due to the procedure.
•Donor Care Post Phlebotomy - the venipuncture site
should be inspected and refreshments should be offered
to the donor before he/she leaves the area.
• Donor Blood Processing - the collected blood unit is
prepared and placed in the proper container for transport
to the processing area.
In performing venipuncture for blood donation, the
phlebotomist should collect and assemble all the
equipment and supplies needed for the procedure ahead
of time. These items should be placed in a tray or cart
which is easy to reach.
The pieces of equipment required include the blood
pressure monitors, scales, donor couches, chairs, beds,
blood collection mixers, blood bag sealers, blood
transportation boxes, and blood bank refrigerators. They
should be maintained and regularly calibrated and ready
to use. They should also be serviced if there is a need to
ensure safety during the procedure recommend that a
closed collection system (sterile blood collection bag
containing anticoagulant with attached tube and needle)
should be used. Diversion pouches could also be used to
minimize contamination from skin flora and to obtain
the first 20 ml. of blood. For hemoglobin testing, a
sterilized lancet (single-use) is utilized, and the collected
blood should immediately be placed in a safety box.
It is important to ensure that the pieces of furniture and
equipment in the blood donation and processing areas
are made of cleanable surfaces such as vinyl. They must
be kept clean and disinfected by sodium hypochlorite
bleach solutions. Fabric or textile carriers should be
machine-washable. World Health Organization (WHO)
guidelines.
Procedure and Necessary Reminders While Doing
Venipuncture for Blood Donation
Step 1: Identify the Donor and Label the Collection Bag
and Test Tubes
Proper identification of the donor is necessary. The
phlebotomist should ask the donor to state his/her full
name. In addition, the phlebotomist should make sure
that the blood collection bag is of the correct type and is
properly labeled along with the satellite bags and sample
tubes. The donor's information (name and number) as
seen on the records should match the label on the
collection equipment.
Step 2: Select the Vein
When selecting a vein for blood donation, the
phlebotomist should choose a large and firm vein such as
the antecubital fossa which is the preferred site for the
venipuncture. The area is checked for any lesions or
scars. The blood pressure cuff or tourniquet should be
inflated to 40-60 mm Hg. The donor is asked to open
and close his/her hand a couple of times. The cuff is
released after the site has been selected and the skin is
prepared for the venipuncture procedure.
•Donated Blood Labeling - the information indicated on
the label found in the blood unit must be doublechecked. It should be complete and accurate.
Step 3: Perform Hand Hygiene and Wear Well-fitting
Gloves
The Minimum Requirements for Venipuncture for Blood
Donation
Proper hand hygiene procedure should be performed
prior to venipuncture for blood donation. Phlebotomists
should wash their hands with soap and water thoroughly
and then dry them using a single use towel.
Alternatively, they could clean their hands with alcohol
if the hands are not visibly soiled or dirty. They should
use 3 mL alcohol to rub their hands (palms, fingertips,
and back of hands) until they are dry. A well -fitting
glove should be worn after performing hand hygiene.
Step 4: Disinfect the Donor's Skin
The selected venipuncture site should also be cleaned
thoroughly, If it is not visibly dirty, simply wash it with
soap and water, and wipe it dry using a wash towel
(single-use). Otherwise, the phlebotomist could perform
either the one-step or two-step procedure.
Step 5: Perform the Venipuncture
Follow these steps when performing venipuncture for
blood donation:
1. Ask the donor to clench his/her fist so that the vein
becomes more prominent.
2. Use approximately a 30-degree angle or less to enter
the vein rapidly and continue to introduce the needle at
the easiest angle of entry.
3. Release the tourniquet once sufficient blood has been
collected (450 mL +/- 10%). Do this before withdrawing
the needle.
4. Gently withdraw the needle and using a clean gauze
or dry cotton ball, apply gentle pressure on the site.
5. Ask the donor to hold the gauge or cotton ball in
place, with his/her arm extended and raised.
6. Warn the donor not to bend his/her arm to avoid
hematoma.
Step 6: Monitor the Donor and the Donated Unit
The donor and the injection site should be monitored
closely all throughout the process. Mix the collected
blood with anticoagulant gently either manually or by
continuous mechanical mixing during the donation
procedure observing approximately a 30-second interval.
Observe the donor for symptoms such as:
changes in blood flow which may mean that the needle
has moved or needs repositioning.
Step 7: Remove the Needle" and Collect the Laboratory
Samples
After completing the procedure, the following steps
should be done to remove the needle: (1) Place a
hemostat just below the needle or a plastic stopper to
stop the bleeding, (2) withdraw the needle, and (3)
collect the samples for testing.
Procedure in Collecting Blood Samples for Donor Unit
Laboratory Testing
Place evacuated tubes and tube holders in a rack prior to
filling when collecting laboratory samples. Do not apply
any pressure to the needle to avoid the risk of hemolysis
and do not release the stopper so as not to let off
pressure. Do not forget to invert the tubes that contain
additives prior to their dispatch.
Procedure in Transporting Blood Donor Units and
Samples
The collected blood donor units are transferred to leakproof storage containers and properly closed. The
specimens should have complete documentation and
must observe to the proper temperature requirements.
Multiple tubes are placed in a rack or padded holder to
prevent breakage while in transit.
LESSON 13 THE FUNCTIONS AND ACTIVITIES OF
THE LABORATORY SAMPLE RECEPTION AREA
LEARNING OUTCOMES
INFORMATION SHEET 13.0
The Functions of the Laboratory Sample Reception Are
The flow of work in the laboratory usually starts in the
sample reception area of the medical laboratory. Various
types of samples ranging from blood to other non-blood
specimens are received in this area. It is important that
these samples are properly handled and there is no room
for any mistakes.
A medical laboratory assistant or laboratory receptionist
is usually assigned in this department to process the
receipt and identify and prepare the laboratory request of
samples for testing. He/She helps ensure that results are
forwarded to the patient and physician in an accurate and
timely manner. He/She may also undertake clerical and
telephone duties.
1. Patient - sweating. pallor, and feelings of fainting or
dizziness.
The Specific Duties of the Laboratory Receptionist
2. Injection site - development of hematoma, and
The laboratory assistant assigned in the sample reception
area is usually called the "laboratory receptionist."
He/She performs office tasks related to handling
laboratory test results and other reports completed in the
laboratory or those received from other laboratories.
His/Her primary duties include but not limited to the
following:
1. Process the receipt, identification, preparation of
samples, and requests entering the medical laboratory.
2. Maintain an accurate log (using a specimen tracker
system) after identification, preparation, and dispatch to
the proper laboratory section.
3. Advise and alert the appropriate laboratory section
about the urgent samples, frozen samples, and samples
that require special handling.
4. Be knowledgeable in handling the laboratory
computer system and confidently use test libraries,
intranet, and referral data during data entry.
5. Take care of the scanning, filing, and archiving of
laboratory request forms and other pertinent documents
and records.
6. Be able to handle incoring calls and use the features of
the telephone system in holding and transferring calls to
the different sections and offices of the laboratory.
request form in Laboratory Quality Stepwise
Implementation Tool Program, The template includes the
following sections:
1. Name of the form includes the name of the laboratory
and receiving date of the specimen being handled.
2. Patient details include the patient's personal
information such as his/her name, address, telephone
number, date of birth, and gender.
3. Requester details contain the information about the
personnel of the company that made the request. The
name of the personnel, the company he/she represents,
and the contact details such as the address and phone
number should be indicated.
4. Sample details provide information about the
specimen being handled. They show the date and time
when the sample was taken, its urgency, if it involved
fasting, as well as the specific type of specimen
provided.
5. Relevant clinical information shows other relevant
details such as drug therapy, the last dose including the
date and time, and other pertinent clinical information.
6. Examination requested shows a list of possible tests
that could he conducted or provided. Cervical cytology
request should also be ticked if needed, and additional
tests should be written in the space provided in the form.
7. Keep himself/herself updated on the current trends
related to the performance of his/her duties.
7. Date and Signature of the Requester
8. Maintain the level of service and professionalism by
ensuring thecompleteness and timeliness of all
procedures through regular documentation.
The Principle and Application of Laboratory
9. Attend to and handle queries about the samples and
requests in a timely and professional manner. 10.
Acquire knowledge on how to operate the pieces of
equipment that are used in the laboratory reception area.
Essential Patient/Client Information Reflected in the
Laboratory Request Form
The laboratory uses a request form (LRF) as a document
that serves as its communication link not only to the
requesting physicians but also to the other users of
laboratory services. It is important to ensure that the
clinical information in these request forms are accurate,
adequate, and free from errors because they will have a
significant impact on the laboratory results and on the
diagnosis and treatment of patients. The World Health
Organization has provided a template for the laboratory
Computer Systems in the Sample Reception Area The
sample reception area plays an important role in the preanalytical phase of laboratory testing. Laboratory errors
are minimized if not totally eradicated if this section will
apply proper organization and traceability procedure.
Adopting a laboratory computer system will improve the
efficiency of the sample reception area because it will
provide easy and fast access to almost error-free
information and ensure that reports generated are
accurate and provided in a timely manner. It also
provides control and oversight on the procedures
performed in the laboratory.
The World Health Organization (WHO) has launched
Laboratory Quality Stepwise Implementation (LQST). It
is a tool that serves as a guide to medical laboratories
worldwide in implementing a quality management
system which is compliant with the ISO 15189
accreditation requirements. In the "Develop an Standard
Operating Procedure (SOP) for Sample Reception and
Processing" a LQSI activity, it is recommended that the
following procedures be included:
• The integrity of the sample must be checked before
acceptance or rejection.
• Samples introduced in the register should be properly
labeled to ensure traceability.
• The laboratory request should be reviewed by
authorized personnel.
• There should be a procedure in place for handling
special cases such as urgent samples or verbal requests.
• Regular review of the required sample volume per test
which may have changed over time.
• Proper procedure for a sample rejection.
The Laboratory Sample Receipt/ Tracking Log Book
As part of the procedure, the laboratory logs or records
all incoming samples in a register of log book. A
laboratory identification number is usigned to the sample
and the corresponding requisition form could be written
or entered into the computer.
The register should include the following information;
collection date and corresponding time; receipt date and
time the specimen was received. type of sample; name of
the patient and other personal information: and tests
requested to be performed.