 HISTORY OF MEDICAL TECHNOLOGY PROFESSION

Introduction 
The Medical Technology Profession has gone tremendous changes and improvements
over the years. These developments have been very essential and beneficial in the
Health Care delivery system.
There are four stages in the historical development of Medical Technology. The earliest
stage begun in 460 BC, followed by the formulation of the Apothecaries Act of 1815, the
modern onset of the Medical technology in the United States in 1871, and the
establishment of clinical laboratory and medical technology course in the Philippines.
Evidently, Medical Technology is still progressing along with new advancements and
discoveries in the field of Science and Technology. Now and in the future, trends in
Medical Technology practices will help meet the demand of the times by enabling the
introduction of more techniques in treating, diagnosing, preventing, and controlling
infectious diseases in a steadfast and comprehensive manner.
The two most important priorities of medical technology are future challenges in the
roles and contributions of medical laboratory technology, and the effort to address gaps
and shortcomings in the field of Medical Technology
Learning Outcomes
At the end of this unit, students will be able to:
1.      Discuss the history of medical technology on a global context.
2.      Discuss the history of medical technology in the United States.
3.      Discuss the history of medical technology in the Philippines.
4.      Identify important personalities that played a significant role in the progress of
medical technology profession.
5.      Discuss the historical milestones in Medical Technology
 Presentation of Contents
 History of Medical Technology on a global context
 The evolution of medical technology can be traced to the understanding of the concept
of diseases and infections during ancient times. In 460 BC, Greek physician Hippocrates,
regarded as the founder of scientific medicine, determined the correlation between
anatomical and chemical laboratory findings and the causes of diseases. He adopted the
triad of regimen in treating diseases and infection with the use of drugs, surgery, and
bloodletting.
            As early as 1550 BC, Vivian Herrick determined that intestinal parasitic infection
was caused by Ascaris lumbricoides and the Taenia species. This was published in a
book by Ebers Papyrus , which describes the treatment of hookworm disease and
infection transmissible in humans. In the same year, Anenzoa, an Arabian physician, also
proved that the etiological agent of skin diseases, such as scabies, is parasites.
            During the medieval period (1098-1438), urinalysis became commonplace and
was a practice that was followed with exaggerated zeal. During that period, some
doctors of dubious credentials in the Indian subcontinent recorded several observations
on the urine of some patients. They determined that the urine of certain patients that
attracted ants had a sweet taste. This information was criticized by some medical
professionals and was even mentioned in the book authored by Ruth Williams, entitled
An Introduction to the Profession of Medical Technology.
            In the 14th century, Anna Fagelson strongly confirmed the beginnings of medical
technology when she correlated the cause of death of Alexander Gillani, a laboratory
worker in the University of Bologna, to laboratory-acquired infection.
            The 17th century witnessed, with the invention of the first functional crude
microscope by Anton Van Leeuwenhoek, rapid advancements in discoveries. Van
Leeuwenhoek was the first scientist to observe and describe the appearance of red
blood cells, and to differentiate bacteria based on their shape.
MEDICAL TECHNOLOGY IN THE 18TH CENTURY
            In the 18th century, medical practitioners in North Africa and Southern Europe
received classical medical education. According to them, there are four basic humors
and the state of balance between these humors can be correlated with the healthy
condition of the human body, and the state of unbalance can be diagnosed by means of
urine examination. The four humors are blood, phlegm, black bile and yellow bile.
            Between 1821 and 1902, Rudolf Virchow was recognized as the father of
microscopic pathology. He was the first scientist/physician of the time who emphasized
the study of the manifestation of diseases and infections, which are visible at the cellular
level by means of a microscope.
            In the process of evaluating disease and infections, Dr. Calvin Ellis, a
microscopist, was the first to utilize the microscope in examining specimens at the
Massachusetts General Hospital. On the other hand, it was Dr. William Occam who used
laboratory findings as preliminary evidence in diagnosing and evaluating a patient's
disease.
            The function of medical technology has become explicitly apparent when the
Apothecaries Act of 1815 intervened and paved the way for an uphaul of medical
treatment based on laboratory findings. This Act was initiated by Baron Karl Von
Humbeldt, who formally used laboratory findings in the treatment of diseases and
infection. The Apothecaries Act 1815 was formulated to better regulate the practice of
apothecaries throughout England and Wales. The Act introduced compulsory
apprenticeship and formal qualifications for apothecaries (in modern terms, general
practitioners) under the license of the Society of Apothecaries. It was the beginning of
regulation of the medical profession in the United Kingdom. The Act required
instruction in anatomy, botany, chemistry, material medical, and “physic," in addition to
six months of practical working experience in a hospital.
HISTORY OF MEDICAL TECHNOLOGY IN THE UNITED STATES
Advances in scientific knowledge in the field of medicine were applicable to both
medical practice and medical education in Europe and America. In the United States,
medical education underwent much needed reforms.
´  Dr. William H. Welch
´  In 1885, Dr. Welch became the first professor of Pathology at John Hopkins University
´  *The first clinical laboratory was opened in 1896 at the John Hopkins Hospital by Dr.
William Osler.
´  * A clinical laboratory was also opened at the University of Pennsylvania in 1896.
(William Pepper Laboratory)
´  Dr. James C. Todd
´  Wrote “A Manual of Clinical Diagnosis”
´  Retitled “Clinical Diagnosis by Laboratory Methods” in the 19 th edition
´  1900: Census
´  100 technicians, all male were employed in the United states
´  1915
´  The state legislature of Pennsylvania enacted a law requiring all hospitals and
institutions to have an adequate laboratory and to employ a full-time laboratory
technician
´  1920
´  Increased to 3,500
´  1922
´  3035 hospitals had clinical laboratories
´  World War I
´  Was an important factor in the growth of the clinical laboratory and produced a great
demand for technicians
´  University of Minnesota
´  Where one of the first schools for training workers was established
´  A course bulletin was entitled “Courses in Medical Technology for Clinical and
Laboratory Technicians” (1922)
´  1921
´  The Denver Society of Clinical Pathologists was organized
´  1923
´  University of Minnesota was the first to offer level program
´  World War II
´  The use of blood increased and the “close system” of blood collection was widely
adopted
´  Laboratory medicine certainly moved into an era of sophistication
HISTORY OF MEDICAL TECHNOLOGY IN THE PHILIPPINES
Medical Technology in the Philippines post-World War II
            At the end of World War II, the first clinical laboratory in the Philippines was built
and established on Quiricada Street, Sta. CruzManila (where the public health laboratory
is presently located) by the 26th Medical Laboratory of the 6th US Army.
            In February 1944, it provided one year of training to high school graduates to
work as laboratory technicians. In June 1945, the staff of the 6th US Army left the facility
after endorsing the newly established Clinical Laboratory to the National Department of
Health. However, its laboratory facilities were not fully utilized and later, it stopped
being used because the science was not popular during those days.
            Dr. Pio de Roda, a Filipino doctor who was a dislocated staff of the 26th Medical
Laboratory and a well-known bacteriologist, preserved the remains of the laboratory
with the help of  Dr. Mariano Icasiano, the first City Health Officer of Manila. On October
1, 1945, the preserved laboratory was formally re-established by Dr. Pio de Roda with
the help of Dr. Prudencio Sta. Ana. They offered free training to most trainees who were
high school graduates and paramedical graduates. With no specific duration of training
and no certification, the training lasted from a week to a month. In 1954, Dr. Pio de
Roda instructed Dr. Sta. Ana to prepare a syllabus for training medical technicians.
Together with Dr. Tirso Briones, they conducted a six month training course with
certification. However, their project did not last long because the Manila Sanitarium
Hospital and its sister company the Philippine Union College offered a course in medical
technology. In the same year, through the efforts of an American medical practitioner
and a Seventh Day Adventist missionary, Dr. Willa Hilgert Hedrick, founder of medical
technology education in the Philippines, Dr. Reuben Manalaysay; president of the
Philippine Union College, Rev. Warren; president of the North Philippine Mission of the
Seventh Day Adventist and director of the Bureau of Education, established the first
Medical Technology School in the Philippines.
            Dr. Hedrick, with the help of Mrs. Antoinette McKelvey, prepared the course
curriculum and established the first complete laboratory in microbiology, parasitology,
and histopathology at the Manila Sanitarium Hospital. In the same year, a five-year
course leading to a Bachelor of Science degree in medical technology was approved by
the Bureau of Education and was finally offered by the Manila Sanitarium Hospital and
the Philippine Union College. In 1956, Mr. Jesse Umali became the first student to
graduate from the Philippine Union College. He later went on to pursue his studies in
medicine and graduated from Far Eastern University.
            Other schools had started to offer the course; for instance, in 1957, the
University of Santo Tomas offered an elective course in pharmacy leading to a bachelor
of science in medical technology under the leadership of Dr. Antonio Gabriel and Dr.
Gustavo Reyes. In 1960–61, the Bureau of Education officially approved the first three
years as a three-year academic course and the fourth year as an internship program. At
the same time, Carmen de Luna, President of the Centro Escolar University delegated
Purification Sunico-Suaco to work on offering the medical technology course, which was
later granted a recognition permit by the Bureau of Education and had its first graduates
two years later.
            In 1961, through the combined efforts of Dr. Horacio Ylagan and Dr. Serafin J.
Juliano with the authority granted to them by Dr. Lauro H. Panganiban and Dr. Jesus B.
Nolasco, dean of the Institute of Medicine, the Far Eastern University started its School
of Medical Technology, which was formally approved by the Bureau of Education. Dr.
Ylagan became the technical director of the school and had its first graduates in 1963.
            Several colleges and universities throughout the country began offering the
bachelor's degree in medical technology. The postgraduate course is now offered at the
University of Santo Tomas and Philippine Women's University.
HISTORICAL MILESTONES IN MEDICAL TECHNOLOGY
MEDICAL TECHNOLOGY AS AN APPLICATION OF SCIENCE AND TECHNOLOGY
            Medical technology employs a wide variety of technologies ranging from a
single-lens microscope to dissecting and scanning electron microscopes. Highly
technical instruments such as the auto analyzer in clinical chemistry or the flow
cytometer in histopathology are typically used in tertiary and highly sophisticated
laboratories. Diagnostics is moving toward automation coupled with the use of
computer graphics, recorders, and even calculators. The use of these technologies in the
scientific evaluation of diseases and infection clearly shows that medical technology is
synonymously adjunct and within the ambit of the term “science and technology.
            Within the context of science and technology, the prime goal of medical
technology is to engender the cultural and democratic notions of scientific literacy. In
addition, science and technology helps students have a better understanding of
scientific learning in order to become better and responsible citizens. The practical value
of science with regard to humankind can be seen through the advancements in
technology. Science and technology have provided society with various benefits like
improved health and standard of living. The direction that technology takes depends
less on science; its progress and development is determined by the needs of humans
and the values of society.
            Medical technology is one discipline that can help students acquire knowledge
beyond the traditional and formal learning about scientific theory, facts, and technical
skills. In addition, it also equip students with a better understanding of scientific learning
and makes them aware of the trends in technological developments, thereby providing
a meaningful impact in their social, political, economic, environmental, and cultural
context of life. Moreover, medical technology has transcended the evaluation of the
health status and condition of every individual member of a society. It is a scientific
discipline that reinforces the concepts and principles of science and technology to
facilitate the understanding of life and the onset of diseases. The concrete application of
these concepts and principles can be seen in the following:
Laboratory Information Systems
            With the evolution of electronic and technological devices, clinical laboratories
are also moving toward innovation and meeting the immediate demands of health
laboratory services. This has led to the development of the ultimate science and
technology product-the Laboratory Information System (LIS). Almost all clinical
laboratories, especially those in the tertiary category, use the LIS to release laboratory
results.
Professional Practice
            In professional practice, there are always guiding policies that should be strictly
followed. A medical technologist should observe the code of ethics and the patient's
rights. The symbol of a microscope will remain synonymous with medical technology.
Genetic Engineering, Gene Therapy, and Gene Diagnosis
            Genetic engineering is the answer to the demands of the current generation. It
enables access to gene therapy and diagnosis. Medical technology uses genetic
engineering methods, especially in cases of detecting genetic disorders such as
hemophilia.
Laboratory Waste Management
            Microorganisms are ubiquitous. Thus, the implementation of laboratory
management should continuously and closely monitor how laboratory wastes are
managed, handled, and disposed. These techniques are used to prevent the spread of
communicable diseases.
Laboratory Diagnosis of Diseases of the 21st Century
           In highly sophisticated and accredited clinical laboratories, automated and
conventional or manual methods are used. This type of setting ensures the accuracy of
laboratory results in diagnosis of diseases of the 21st century. Epidemiologically
speaking, these diseases may be endemic or epidemic depending on the climatic
changes. For example, the HINI influenza viral infection has become the focus of
attention due to significant infection rates, which signalled a need for accurate
laboratory diagnosis. And just recently the world is facing another challenge this is the
SARS-Cov-2 virus (COVID-19)). It has been considered a pandemic viral infection causing
thousands of deaths worldwide in just a matter of months. Thus the need for very
reliable and accurate laboratory diagnosis for early treatment of the disease.
Scientific Research
          Many new products and laboratory procedures have been systematically
established through the efforts and enthusiasm of medical technology professionals.
Current research is moving toward the molecular diagnosis of diseases and infections.
The ultimate goal of medical technology is its commitment to focus on more
discoveries. This goal can be attained through the efforts extended by science and
technology.
Inventions and Innovations in the Field of Medical Laboratory
1660 – Anton Van Leeuwenhoek
                        - Father of Microbiology
                         - Known for his work on the improvement of the microscope
1796 – Edward Jenner
                        - Discovered Vaccination to establish immunity to small pox
                        - impact of contribution: Immunology
1880 – Marie Francois Xavier Bichat
                        - Identified organs by the types of tissues
                        - Imapct of contribution: Histology

1835 – Agostino Bassi

                        - Produced disease in worms by injection of organic material
                        - impact of contribution: beginning of bacteriology
1857 – Louis Pasteur
                        - Successfully produced immunity to rabies
1866 – Gregor Mendel
                        - Enunciated his law of inherited characteristics from studies on plants
1870 – Joseph Lister
                        - Demonstrated that surgical infections are caused by airborne
organisms.
1877 – Robert Koch
                        - Presented the first pictures of bacilli (anthrax) and tubercle bacilli
1886 – Ellie Metchnokoff
                        - Described phagocytes in blood and their role in fighting infection
1886 – Ernst Von Bergmann
                        - Introduced steam sterilization in surgery
1902 – Karl Landsteiner
                        - Distinguished blood groups through the development of the
ABO blood group system
1906 – August von Wassermann
                        - Developed immunologic tests for syphilis
1906 – Howard Ricketts
                        - Discovered microorganisms whose range lies between bacteria and
virus called rickettsiae
1929 – Hans Fischer
                        - Worked out the structure of hemoglobin
1954 – Jonas Salk
                        - developed poliomyelitis vaccine
1973 – James Westgard
                        - Introduced the Westgard Rules for Quality Control in the Clinical
                          Laboratory
1980 – Baruch Samuel Blumberg
                        - Introduced the Hepatitis B vaccine
1985 – Kary Mullis
                        - Developed the Polymerase Chain Reaction (PCR)
1992 – Andre van Steirteghem
                        - introduced the intracytoplasmic sperm injection (IVF)
1998 – James Thomson
                        - Derived the first human Stem Cell line
FUTURE TRENDS:
Latest technologies include robotic devices, keyhole surgery procedures and genetic
engineering created from knowledge about DNA molecules
 

           
 Unit 2:DEFINING THE PRACTICE OF THE MEDICAL TECHNOLOGY/CLINICAL
LABORATORY SCIENCE PROFESSION

Medical Technology as a clinical laboratory science is a multi-faceted in nature.  Medical

technology use a wide range of technologies to diagnose certain diseases and
infections. Such technologies include the use of an autoanalyzer in sophisticated tertiary
category, flow cytometry histopathology, and high performance chromatography for
drug analysis.
 
Medical Technology encompasses, scientific inquiry in various societal health problems
and involves a wide range of laboratory investigations.
 
Medical technology serves as the “clinical eye” in diagnosing and treating diseases and
infections. In every aspect of medical procedures, a physician always resort to laboratory
findings in giving the right prognosis of diseases and infections.
 
Presentation of Contents

PRACTICE OF MEDICAL TECHNOLOGY PROFESSION

Roles and Responsibilities of Medical Technology Professionals

            Medical Technology is indeed a rapidly advancing discipline and profession. The
role of medical technology professionals in the diagnosis and treatment of diseases is
very crucial in health care practice. In the Philippines, R.A. 5527 or the Medical
Technology Act of 1969, defines the scope of work of the different medical technology
professionals. There is no doubt that the role of the medical technologist is to
collaborate with other health care practitioners to provide humane and dignified health
service. The following are the tasks of medical technology professionals in the practice
of laboratory science.
Perform Clinical Laboratory Testing
            A medical technologist must be capable of performing the most basic to the
most advanced laboratory tests. A graduate of Bachelor of Science in Medical
Technology/Medical Laboratory Science is expected to show competency in performing
routine laboratory tests including urinalysis and stool examination. He or she should be
capable of performing hematologic, microbiologic, serologic, chemical, and other
procedures in the different areas of laboratory science. In turn, it is expected that the
clinical laboratory will be equipped with the resources necessary for performing such
procedures or any kind of laboratory testing.

Perform Special Procedures

            Medical technologists are also expected to perform special procedures in
diagnosing diseases. These may include the operation of advanced diagnostic
equipment. Special procedures can also include molecular and nuclear diagnostics.
Ensure Accuracy and Precision of Results
            In performing different procedures to diagnose diseases, a medical technologist
should always be conscious of the accuracy and precision of both the testing process
and its results. Accuracy and precision impacts the interpretation of results by the
physician to provide proper medication in the treatment of diseases.
Be Honest in Practice
            A practicing medical technologist, like any other professional, is expected to be
honest in the practice of his or her work. It is important that a medical technologist
values honesty, particularly in conveying or reporting the results of any laboratory
procedure. He or she should act according to the Medical Technology profession's Code
of Ethics and his or her pledged oath of practice. A medical technologist must be honest
at all times in the conduct of test procedures to come up with accurate and precise
results.
Ensure Timely Delivery of Results
In collaborating with other health care practitioners, a medical technologist MUST be
aware of the urgency of delivering results on time especially in cases that require
treatment. There are times when physicians will request laboratory tests which require
immediate action. One should take notations on "STAT” or even observe the source of
the requests (e.g., from the emergency room [ER] or operating room [OR]). It is
important for a medical technologist to be alert to fully address the needs of the
patient. Since laboratory procedures are time bound, it is important that a medical
technologist is able perform the duties required of him or her, as soon as possible.
Demonstrate Professionalism
            A medical technologist must be able to perform his or her functions according to
the professional Code of Ethics for medical technology professionals. He or she should
be aware of the laws and regulations governing the practice of medical technology and
should not exploit its function beyond its boundaries. In the Philippines, the practice of
medical technology profession is governed by R.A. 5527 or the Philippine Medical
Technology Act of 1969. Other governing regulations are supplemented by the Clinical
Laboratory Act of 1966 (R.A. 4688) and the Blood Banking Acts of 1956 (R.A. 1517) and
1995 (R.A. 7719). National organizations such as the Philippine Association of Medical
Technologists, Inc. (PAMET) and the Philippine Association of Schools of Medical
Technology and Public Health, Inc. (PASMETH) also have their own constitutions and by-
laws in accordance with the governing laws and code of ethics.
 
Uphold Confidentiality
            Ensuring confidentiality of patient's information is one of the core duties within
the medical practice (De Bord et al.). Confidentiality requires health care providers to
keep a patient's personal health information private unless the patient consents to
release the information. Patient records are expected to be kept in confidence by the
medical technologist. It is expected that these records containing very important
information are protected and made available only when necessary. A medical
technologist must be aware at all times of the value of confidentiality and the entirety of
the ethical codes of their profession.
Collaborate with Other Health Care Professionals
A medical technology professional is required to collaborate with other health care
practitioners in order to build a well-functioning team. Most often, projects fail because
people fail to cooperate with others. Collaboration is the act of working together in
order to achieve a desired outcome. Success in the health care setting is achieved not
because of the availability of highly sophisticated hospital or laboratory equipment, but
because of teamwork. A highly-trained physician will only be able to efficiently treat his
or her patient if laboratory testing, monitoring, drug prescription and dosage, and more
are properly rendered administered by other health care professionals. These protocols
cannot be done by the physician alone. Having one non-collaborative and incompetent
member in the team and can result in potentially dire repercussions.
Conduct Research
            Practicing medical technologists must also be engaged in research activities to
enhance their skills. Research work, whether experimental or descriptive can contribute
significantly to the discovery of new knowledge in the field of medical technology and in
assessing and revisiting already known ones. It can greatly help in the further
development of the field and may be used as future reference for patient care.
Involvement in Health Promotion Programs
            Medical technologists should not be confined only to the four corners of their
clinical laboratories. Medical technology is a multi-disciplinary field which consistently
ventures into other areas of health care including health promotion. A medical
technology professional must be actively involved in reaching out to the community.
There are many ways by which the medical technology profession can help improve the
lives of people. Other health care professionals such as nurses and physicians are easily
seen in community outreach programs because of the nature of their professions.
Medical technologists, as valuable health care professionals, are also expected to do the
same. The following are some ways that medical technology professionals can help the
community:
1.      Cooperate with other health care professionals in health promotion campaigns
such as promoting the ideal attitudes on hygiene, community sanitation, waste
segregation, and disease prevention.
2.      Implement pre-planned programs of health promotion campaigns.
3.      Offer free laboratory testing such as blood typing, urinalysis, fecalysis, blood sugar
testing, cholesterol testing, and other tests beneficial to the entire community.
4.      Collaborate with other health care professionals once diagnoses are done.
DEFINING THE PRACTICE OF OTHER LABORATORY PERSONNEL
The following is a list of other valuable laboratory personnel with various roles in the
health care delivery system, specifically in the area of laboratory medicine. It is
important to note that medical technologists work closely with these laboratory
personnel in order to provide accurate and precise laboratory results. The different roles
of different laboratory personnel are interconnected. It is important that all should work
in harmony in order to provide the best patient care.
Pathologist
            As defined in R.A. 5527
            A pathologist is a duly registered physician who is specially trained in
medical laboratory medicine, or the gross and microscopic study and interpretation of
tissues, secretions and excretions of the human body and its functions in order to di
disease, follow its course, determine the effectively of treatment, ascertain cause of de
and advance medicine by means of research (Section 2, b.).
            A pathologist is always considered to head a clinical laboratory and monitor all
laboratory results. A laboratory result without the signature of a pathologist may not be
considered valid.
Medical Laboratory Technicians
            As defined in R.A. 5527:
            A medical laboratory technician is a person certified by and registered with the
Board of Medical Technology and qualified to assist a medical technologist and/or
qualified pathologist in the practice of medical technology as defined in the
aforementioned act (Section 2, d.).
            There are certain qualifications other than what is stated above to become a
medical technician provided that he or she satisfies the qualifications such that he or
she:
a.       Failed to pass the medical technology licensure examination given by the Board of
Medical Technology but obtained a general rating of at least 70% and provided finally
that a registered medical laboratory technician when employed in the government shall
have the equivalent civil service eligibility not lower than the second grade;
b.      Passed the civil service examination for medical technicians given on March 21,
1969; or
c.       Finished a two-year college course and has at least one (1) year experience of
working as a medical laboratory technician; provided that for every year of experience in
college, two (2) years of work experience may be substituted; and provided further, that
the applicant has at least ten (10) years of experience as medical laboratory technician
as of the date of approval of this decree.
Phlebotomist
            A phlebotomist is an individual trained to draw blood either for laboratory tests
or for blood donations. When only small quantities of blood are needed, a phlebotomist
can draw blood by simply puncturing the skin but when larger volumes of blood are
needed, venipuncture or even arterial puncture is done. Arterial collection can only be
performed by a specially trained phlebotomist. Nowadays, phlebotomy is a skill
confined not only to medical technologists but to other health care practitioners as well,
provided that they were given certification by a reputed certifying or training body.
            In the Philippines, a medical technologist is required to be skilled in phlebotomy.
Although, in other countries, phlebotomists need not get a degree (Cardona et al.,
2015). They are trained on the job and go through phlebotomy programs sponsored by
community colleges which take as little time as two months. After completing the
program, they may take an examination for them to be recognized as a certified
phlebotomist by the American Society for Clinical Pathology (ASCP), American Medical
Technologist (AMT), and the National Healthcareer Association (NHA).
Cytotechnologist
            A cytotechnologist is a laboratory personnel who works with the pathologist to
detect changes in body cells which may be important in the early diagnosis of diseases.
This is primarily done by examining microscopic slides of body cells for abnormalities or
anomalies in structures, indicating either benign or malignant conditions. A
cytotechnologist selects and sections minute particles of human tissue for microscopic
study, using microtomes and other equipment and employs stain techniques to make
cell structures visible or to differentiate its parts. The Papanicolaou (Pap) test and the
H&E are the most commonly employed staining techniques.
Histotechnologist
            A histotechnologist, also referred to as histotechnican, is a laboratory personnel
responsible for the routine preparation, processing, and staining of biopsies and tissue
specimens for microscopic examination by a pathologist (Cardona, 2015). Although
there is no formal training for histotechnologists in the Philippines, being a
histotechnologist is perceived to be a decent paramedical profession abroad. In the
United States, one can complete a histotechnician program accredited by the National
Accrediting Agency for Clinical Laboratory Science (NAACLS). This program usually takes
a year to complete and covers courses in chemistry, histology, immunology,
biochemistry, and medical ethics. Aspiring histotechnologists can also complete an
associate degree program in a reputable health facility that includes supervised
histology training to gain an associate degree in Applied Science (AAS) major in
Histology.
Nuclear Medical Technologist
            A nuclear medical technologist is a health care professional who works alongside
nuclear physicians. Nuclear medical technologists apply their knowledge of radiation
physics and safety regulations to limit radiation exposure, prepare and administer
radiopharmaceuticals, and use radiation detection devices and other kinds of laboratory
equipment that measure the quantity and distribution of radionuclides deposited in the
patient or in the patient's specimen.
Toxicologist
            A toxicologist studies the effects of toxic substances on the physiological
functions of human beings, animals, and plants to develop data for use in consumer
protection and industrial safety programs. He or she also designs and conducts studies
to determine physiological effects of various substances on laboratory animals, plants,
and human tissue, using biological and biochemical techniques.
 
 UNit 3: MEDICAL TECHNOLOGY/ CLINICAL LABORATORY SCIENCE
EDUCATION
Introduction 
Medical technology education in the Philippines is governed and regulated by the
Commission on Higher Education (CHED) under CMO no. 13, series of 2017. The medical
technology program leads to a degree in Bachelor of Science in Medical Laboratory
Science/ Bachelor of Science in Medical Technology which is a four-year course with
professional licensure examination upon the completion of the required units. To
become a professional/practicing medical laboratory scientist/medical technologist, a
graduate of this program needs to pass the licensure examination in medical
technology, following which a license is granted by the Professional Regulation
Commission by virtue of RA 5527 (Medical Technology Act of 1969). A practicing and
duly licensed medical technologist/ medical laboratory scientist can then become a
member of a professional organization, namely the Philippine Association of Medical
Technologists (PAMET) or the Philippine Association of Schools of Medical
Technology/Public Health (PASMETH), and enjoy the benefits and Privileges extended
by such organizations. In other countries, medical technology education is regulated by
the ministry of education, except those universities where the program is accredited by
the accreditation agency or enjoys autonomous status. There are international
professional organizations that can absorb registered medical technologists or clinical
laboratory scientists of other countries under the provision of a reciprocity clause.
Presentation of Contents
 Medical Technology Curriculum
The Commission on Higher Education (CHED) was established on May 18, 1994 through
the passage of Republic Act No. 7722, the Higher Education Act of 1992. CHED is the
government agency under the Office of the President of the Philippines that covers
institutions of higher education both public and private. It is tasked to organize and
appoint members of the technical panel for each discipline/program area. Under CHED
is the Technical Committee for Medical Technology Education (TCMTE) which is
composed of leading academicians and practitioners responsible for assisting the
Commission in setting standards among institutions offering Bachelor of Science in
Medical Technology/Medical Laboratory Science program and in monitoring and
evaluating such institutions. The BSMT/BSMLS program is considered one of the allied
health programs (others, to name a few, are Nursing,  Pharmacy, Physical Therapy,
among others.).
 
The BSMT/BSMLS is a four-year program consisting of general education professional
courses that students are expected to complete within the first three years. Fourth year
is dedicated to the students' internship training in CHED-accredited to laboratories
affiliated with their college/department.          The Commission issued CHED
Memorandum Order (CMO) No. 13, series of 2017 (Policies, Standards, and Guidelines
for the Bachelor of Science in Medical Technology/ Medical Laboratory Science
program) as a guide for institutions offering the program, CMO contains the goals,
program outcomes, performance indicators, and the minimum course offerings (general
education core courses, and professional courses with allotted units) of the
BSMT/BSMLS program. This new CMO is compliant with the K-12 Curriculum
Educational institutions offering the program are given certain leeway in enhancing the
curriculum for their program.
 The prescribed minimum number of units per course, and whether each course has a
laboratory or lecture component, are also indicated in the new CMO. One unit of lecture
is equivalent to one hour of class meeting every week. Thus, a 3-unit lecture course
renders 3 hours of class meeting per week which is equivalent to 54 hours per semester
(if one school year is divided into two semesters, with each semester equivalent to 18
weeks). Principles of Medical Laboratory Science 1 is an example of a 3-unit lecture
without a laboratory component. One unit of laboratory is equivalent to 3 hours of class
meeting every week. An example is Clinical Bacteriology which is a 5-unit course
composed of 3 units of lecture and 2 units of laboratory. This is equivalent to 3 hours of
lecture and 6 hours of laboratory work (total of 54 lecture hours and 108 laboratory
hours per semester).
 In the MT/MLS curriculum, the policy of taking prerequisites for some courses is
followed. A student taking the BSMT/BSMLS program must be aware of the courses he
or she needs to take in order to move on to more advanced courses in the curriculum.
For example, before taking the course Immunology and Serology, one should have
already completed the course Clinical Bacteriology.
 General Education Courses
General Education (GE) course offerings cut across different programs. These courses
aim to develop foundational knowledge, skills, values, and habits necessary for students
to succeed in life, to positively contribute to society, to understand the diversity of
cultures, to gain a bigger perspective and understanding of living with others, to respect
differences in opinions, to realize and accept their weaknesses and improve on them,
and to further hone their strengths. Thus, GE courses aim to develop humane individuals
that have a deeper sense of self and acceptance of others. The general courses included
in the new CMO are
1.      Understanding the Self
2.      Readings in Philippine history
3.       The Contemporary World
4.       Mathematics in the Modern World
5.       Purposive Communication
6.       The Life and Works of Rizal
7.       Science, Technology, and Society
8.       Art Appreciation
9.      9. Ethics
Professional Courses
Professional courses are taken for learners to develop the knowledge, technical
competence, professional attitude, and values necessary to practice and meet the
demands of the profession. Critical thinking skills, interpersonal skills, collaboration, and
teamwork are also developed. Some of the professional courses are
1.      Principles of Medical Laboratory Science 1: Introduction to Medical
Laboratory Science, Laboratory Safety, and Waste Management
            This course deals with the basic concepts and principles related to the Medical
Technology/Medical Laboratory Science profession. Its emphasis is on the curriculum,
practice of the profession, clinical laboratories, continuing professional education,
biosafety practices, and waste management.
2.      Principles of Medical Laboratory Science 2: Clinical Laboratory Assistance and
Phlebotomy
             Clinical Laboratory Assistance encompasses the concepts and principles of the
different assays performed in the clinical laboratory. Phlebotomy deals with the basic
concepts, principles, and application of the standard procedures in blood collection,
transport, and processing. It also involves the study of pre-analytic, analytic, and post-
analytic variables that affect reliability of test results.
3.      Community and Public Health for MT/MLS 1 Public Health for MT/MLS
            This course involves the study of the foundations of community health that
include human ecology, demography, and epidemiology. It emphasizes the promotion
of community, public, and environmental health and the immersion and interaction of
students with people in the community.
4.      Cytogenetics
            This course is focused on the study of the concepts and principles of heredity
and inheritance which include genetic phenomena, sex determination, and genetic
defects rooted in inheritance, among others. It also discusses the abnormalities and
genetic disorders involving the chromosomes and nucleic acids (DNA and RNA).
Emphasis is given to the analysis of nucleic acids and their application to medical
science.
5.      Human Histology
            This course deals with the study of the fundamentals of cells, tissues, and oro
with emphasis on microscopic structures, characteristics, differences, and functi The
laboratory component of this course primarily deals with the microscopic identification
and differentiation of cells that make up the systems of the body.
6.      Histopathologic Techniques with Cytology
            This course covers the basic concepts and principles of disease processes,
etiology and the development of anatomic, microscopic changes brought about by the
disease process. It deals with the histopathologic techniques necessary for the
preparation of tissue samples collected via surgery, biopsy, and/or autopsy for
macroscopic and microscopic examinations for diagnostic purposes.
            Some of the tests that students perform for the laboratory component of the
course in a school-based laboratory are
•         Tissue processing techniques
•         Cutting of processed tissues
•         . Staining
•         Mounting of stained tissue for microscopic examination
•         Performing biosafety and waste management
7.      Clinical Bacteriology
            This course deals with the study of the physiology and morphology of bacteria
and their role in infection and immunity. Its emphasis is on the collection of or to
specimen and the isolation and identification of bacteria. It also covers antimicrobial
susceptibility testing and development of resistance to antimicrobial substances.
             Some of the procedures and tests that students perform for the laboratory Dos
component of the course in a school-based laboratory are .
•         Preparation of culture media
•         Collection of specimen
•         Preparation of bacterial smear
•          Staining of smear
•          Inoculation of specimen on culture media
•         Characterization of colonies of bacteria growing in culture media
•         Performing different biochemical tests for identification of bacteria.
•          Biosafety and waste management
•         Quality assurance and quality control
•         Antimicrobial susceptibility testing
8.      Clinical Parasitology
            This course is concerned with the study of animal parasites in human and their
medical significance in the country. Its emphasis is on the pathophysiology,
epidemiology, life cycle, prevention and control, and the identification of ova and/or
adult worms and other forms seen in specimens submitted for diagnostic purposes.
            Some of the procedures and tests that students perform for the laboratory
component of the course in a school-based laboratory are
·         Microscopic identification of diagnostic features of different groups of parasites
pathogenic to man (e.g., nematodes, trematodes, cestodes, protozoa, plasmodium,
among others)
·          Different methods of preparing smear for microscopic examination (direct fecal
smear, Kato-Katz, among others)
 9.      Immunohematology and Blood Bank
            This course tackles the concepts of inheritance, characterization, and laboratory
identification of red cells antigens and their corresponding antibodies. It also covers the
application of these antigens and/or antibodies in transfusion medicine and transfusion
reactions work-up.
             Some of the procedures and tests that students perform for the laboratory
component of the course in a school-based laboratory are:
 • ABO and Rh typing
 • Coombs test (direct and indirect Coombs)
 • Blood donation process
• Compatibility testing
• Transfusion reaction work-up
• Preparation of RBC suspension
10.  Mycology and Virology
            This course deals with the study of fungi and viruses as agents of diseases with
emphasis on epidemiology, laboratory identification and characterization, and
prevention and control.
11.  Laboratory Management
            This course looks into the concepts of laboratory management which are to the
planning, organizing, staffing, directing, and controlling as applied in clinical laboratory
setting. It also tackles the process of solving problems, quality assurance and quality
control, preparation of policy and procedure manuals, and other activities necessary to
maintain a well-functioning laboratory.
12.  Medical Technology Laws and Bioethics
            This course encompasses various laws, administrative orders, and other any legal
documents related to the practice of Medical Technology/Medical Laboratory Science in
the Philippines.
            Bioethics looks into the study of ethics as applied to health and health care
delivery and to human life in general. Different bioethical principles,
philosophical principles, virtues and norms, and the Code of Ethics of medical
technologists are also discussed.
13.  Hematology 1
            This course deals with the study of the concepts of blood as a tissue. Formation,
metabolism of cells, laboratory assays, correlation with pathologic conditions, special
hematology evaluation are given emphasis. Quality assurance and quality control in
hematology laboratory as well as bone marrow studies are also discussed.
            Some of the procedures and tests that students perform for the laboratory -
component of the course in a school-based laboratory are:
·         Complete blood count (CBC)
·         Hematocrit blood test
·         Platelet count
·         Preparation of blood smear and staining
·          Red cell morphology
·          Erythrocyte sedimentation rate (ESR)
·          Fragility test
·          Erythrocyte indices
·          Reticulocyte count
·          Instrumentation
·          Osmotic fragility test
·         Quality assurance and quality control
·          Biosafety and waste management
14.  Hematology 2
            This course deals with the concepts and principles of hemostasis, and
abnormalities involving red blood cells (RBC), white blood cells (WBC), and platelets.
Laboratory identification of blood cell abnormalities, quantitative measurement of
coagulation factors, and disease correlation are emphasized.
            Some of the procedures and tests that students perform for the laboratory
component of the course in school-based laboratory are
·         Identification of abnormal RBC and WBC
·          Special staining techniques
·         Coagulation factor test (e.g., activated partial thromboplastin time (API,
Prothrombin time [PT], Bleeding time [BT), Clotting time P retraction time [CRT])
·         Instrumentation
15.  Clinical Microscopy
            This course focuses on the study of urine and other body fluids (excluding
blood). It includes the discussion of their formation, laboratory analyses, disease
processes, and clinical correlation of laboratory results.
            Some of the procedures and tests that students perform for the laboratory
component of the course in a school-based laboratory are:
·         Routine urinalysis (macroscopic, microscopic, chemical examinations)
·          Special chemical examination of urine
·         Examination of other body fluids (seminal fluid, gastric juice, cerebrospinal fluid)
·         Pregnancy tests
·          Chemical examination of stool specimens
16.  Clinical Chemistry 1
             This course encompasses the concepts and principles of physiologically active
soluble substances and waste materials present in body fluids, particularly in the blood.
The study includes formation, laboratory analyses, reference values and clinical
correlation with pathologic conditions. The course also looks into instrumentation and
automation, quality assurance, and quality control.
            Some of the procedures and tests that students perform for the laboratory
component of the course in a school-based laboratory are
·         Instrumentation
·         Quality assurance and quality control
·         Glucose determination
·         Lipid testing (triglyceride, lipoproteins)
·         Renal function tests (blood urea nitrogen (BUN), blood uric acid (BUA),creatinine]
·         Protein testing (total proteins, albumin, globulin)
·         Biosafety and waste management
17.  Clinical Chemistry 2
            This course is a continuation of Clinical Chemistry 1 and deals with the concepts
and principles of physiologically active soluble substances and waste materials present
in body fluids, particularly in the blood. It also covers the study of endocrine glands and
hormones and their formation, laboratory analyses, and clinical correlation. Therapeutic
drug monitoring and laboratory analysis of drugs and substances of abuse as well as
toxic substances are also emphasized.
            Some of the procedures and tests that students perform for the laboratory
component of the course in a school-based laboratory are:
·         Bilirubin test
·         Clinical enzymology (transferases, dehydrogenase, hydrolases)
·         Electrolyte testing
·         Hormone testing
·          Drug tests
18.  Seminars 1 and 2
            This course is taken during the student's fourth year in the program together
with the internship training. It deals with current laboratory analyses used in the dra
oniqe of medical technology.
19.  Molecular Biology and Diagnostics
            Molecular Biology deals with the nucleic acid and protein molecule interactive
within the cell to promote proper growth, cell division, and development. It covers the
molecular mechanisms of DNA replication, repair, transcription, translation, protein
synthesis, and gene regulation.
             This course is focused on the concepts, principles, and application of molecular
biology in clinical laboratory. It also deals with the application of different molecular e
techniques as tools in the diagnosis of diseases.
 Research Courses
Research courses required in the BSMT/BSMLS program are Research 1: Introduction
to Laboratory Science Research and Research 2: Research Paper Writing and
Presentation. Research 1 deals with the basic concepts and principles of research as
applied in Medical Technology/Clinical Laboratory Science. Ethical principles, as applied
in research, are also emphasized. Research 2, on the other hand, covers the
methodology of the research (approved in Research 1), writing the research paper in the
format prescribed by the institution and international research agencies for possible
publication, and presentation of the finished and completed research in a formal forum.
 
Clinical Internship Training
Clinical internship training is taken during the students' fourth year in the program. Only
those who have completed and passed all the academic and institutional requirements
for the first three years of the program, and other requirements as specified in the
official documents of the institution, college and/or departments are qualified for
internship. Before proceeding with the actual training, students are required to undergo
physical and laboratory examinations which include, but not limited to, complete blood
count (CBC), urinalysis, fecalysis, chest X-ray and/or sputum microscopy, Hepatitis B
surface antigen (HBsAg, and Hepatitis B surface antibody (HBsAb) screening, and drug
testing (for methamphetamine and cannabinoids). Proof of vaccination for hepatitis B is
also a requirement.
This intensive training aims to apply the theoretical aspects of the profession into
practice. Students are assigned to CHED-accredited clinical laboratories affiliated with
their academic institution on a 6-month or one-year rotation. This rotation ensures that
all students experience to work in the different sections of a clinical laboratory, namely
clinical chemistry, hematology, immunohematology (blood banking), clinical
microscopy, parasitology, microbiology, immunology and serology,
histopathology/cytology, and other emergen technologies.
The intern is required to render 32 hours of duty per week not exceeding a total of 1,664
hours in one year. This is broken down per section as follows (based on CMO 13 s.
2017): Clinical Chemistry
300 hours Clinical Chemistry
200 hours Clinical Microscopy and Parasitology
250 hours Microbiology
300 hours Hematology
200 hours Blood Banking
100 hours Histopathologic techniques and Cytology
220 hours Immunology and Serology
40 hours Laboratory Management (collection, handling, transport, and receiving of
specimens, quality assurance, safety and waste management)
54 hours Phlebotomy for a TOTAL of 1,664 hours  
The academic institution is required to conduct an orientation to prospective interns
regarding the policies and guidelines on internship training as contained in the
Internship Training Manual.
 
Licensure Examination
The Medical Technologist Licensure Examination is conducted in order to identify
graduates who possess the basic qualifications or the minimum conceptual skills and
technical competencies to perform the tasks with minimum errors.
The Professional Regulation Commission (PRC) is the government agency, under the
Office of the President of the Philippines, tasked to administer licensure examinations to
different professionals. Meanwhile, the Professional Regulatory Board (PRB) for Medical
Technology/Medical Laboratory Science, under the PRC, is tasked to prepare and
administer the written licensure examinations for graduates qualified to take the
examination. PRB is composed of a chairperson, who must be a duly licensed
pathologist, and two members should be both registered medical technologists. All
members of the PRB are required  holders of PRC licenses. At present, the Medical
Technologist Licensure Examination is administered twice a year, on the months of
March and August.
            Listed below are some of the provisions included in Republic Act 5527, "The
Technology Act of 1969," in relation to the licensure examination:
1.      The courses included in the licensure examination and their corresponding
percentages are as follows:
·         Clinical Chemistry 20%
·         Microbiology and Parasitology 20 %
·         Hematology 20 %
·         Blood Banking and Immunology and Serology 20%
·         Clinical Microscopy 10%
·         Histopathologic Techniques (MTLaws and Bioethics and Laboratory Management
- not  written in R.A. 5527, but are now included in the board exam) 10%
 
2.      To pass the exam, an examinee must:
·         receive a general weighted average of 75%
·         have no rating below 50% in any major courses, and
·         Pass in at least 60% of the courses computed according to their relative weights.
 
3.      If an examinee passed the examination and is 21 years old and above, he or she
will be issued a certificate of registration and a PRC card as a licensed medical
technologist. If an examinee is younger than 21 years old, he or she will register as a
professional after his or her 21st birthday.
4.       If an examinee failed to pass the licensure examination three times, he or she
needs to enroll in a refresher course before retaking the examination.
5.       If an examinee failed to pass the examination but garnered a general weighted
average of 70%-74%, he or she may apply for certification as a medical laboratory
technician.
 
Competency Skills of Medical Technologist//Clinical Laboratory Scientist in the
21st century
Program Goals and Learning Outcomes
All higher educational institutions (HEIS) offering any graduate and/or undergraduate
degree programs must have a written document stating the program goals, vision and
mission, objectives, and learning outcomes based on the institutions' philosophy.
Learning outcomes are general statements that define what the learner has to achieve.
These learning outcomes serve as the foundation of curriculum development and
teaching methodologies that shape a program. When learning outcomes are clearly
stated, shared responsibilities and accountabilities for learning are developed in both
students and teachers.
The learning outcomes of the Bachelor of Science in Medical Technology (BSMT)/
Bachelor of Science in Medical Laboratory Science (BSMLS) program state the
knowledge, skills, values, and ethics that graduates of the program should demonstrate.
Demonstration of such outcomes will result in competent and skillful professionals who
are ready to skillfully perform the tasks of the profession enabling them to contribute to
the welfare of the country and to improve the quality of life of the people whom they
serve.
 
            The program outcomes of the BSMT/BSMLS degree expect students to
1.      demonstrate knowledge and technical skills needed to correctly perform
laboratory testing and ensure reliability of test results
             Knowledge is comprised of facts, information, and concepts acquired through
experience and education. Knowledge is important in order to understand the task to be
accomplished-be it technical and/or management of a section or a whole laboratory. A
knowledgeable graduate must have the confidence and necessary competencies to
contribute towards the resolution of the problem or conflict at hand.
            Technical skills relate to the psychomotor domain of learning. Medical
technology/medical laboratory science practice is primarily concerned with the
laboratory analyses of specimens carried out with utmost consideration for reliability of
test results. A BSMT/BSMLS graduate should be able to perform the tests in each
section of the laboratory, to control possible sources of errors or variability, and to
understand the plausibility of test results. A graduate's technical skill will be employed in
specimen collection, transport, and processing, manual testing and automation of
equipment, molecular biology techniques, as well as in biosafety and waste
management practices.
2.      be endowed with the professional attitude and values enabling them to work
with their colleagues and other members of the health care delivery system
            Attitude deals with the affective domain. Learning outcomes in this domain look
into the feelings, emotions, tone of voice, attitude, and disposition of a BSMT/BSMLS
graduate when confronted with favorable or unfavorable situations in the workplace. It
also deals with his or her motivation to further improve himself or herself; how he or she
reacts to criticism, rejection, and praise; and his or her enthusiasm and desire vito
contribute to the well-being of the stakeholders.
3.      demonstrate critical thinking and problem solving skills when confronted
with to situations, problems, and conflicts in the practice of their profession
            Critical thinking is the ability of an individual to objectively and systematically
analyze, without bias, facts and information to come up with reasonable decisions and
to guide behavior. Problem solving involves the detailed analysis of the problem at hand
by focusing on present facts and information before making a decision. Decision making
entails one's ability to gather and synthesize facts, information, and opinions about the
problem at hand. It also involves looking into alternative courses of action to be
undertaken at the shortest time possible, even under extreme pressure. After a decision
is made, there is a need to monitor the effect and importance of the decision on the
department or the organization as a whole. Corrective activities should be instituted if
the desired outcomes are not attained.
            These skills are necessary for one to function well in the workplace as solving
problems and making decisions are constant.
4.      actively participate in self-directed life-long learning activities to be update
with the current trends in the profession
            The emergence and re-emergence of infectious agents, changes in
demographics demands of patients for efficient health care services, changes in medical
technologies, state and local legislations on the BSMT/BSMLS practice, and clinical
laboratory personnel taking more complex roles are some of the issues in the medical
technology profession. To address these issues, clinical laboratories must always be
updated with the current trends and employ the necessary changes. The education of
the medical technologists/medical laboratory scientists is part of the upgrade. Being a
BSMT/BSMLS graduate does not entail that the process of learning has already been
completed and acquired. MT/MLS practice involves a state of constant learning and re-
learning to efficiently carry out the responsibilities and accountabilities of being a
medical technology professional.
            Thus, there is a need to engage in self-directed learning to be updated with the
constant changes in the medical technology practice. It is also ideal for one to take part
in training programs, workshops, and even enroll in graduate programs related to the
profession.
5.      actively participate in research and community-oriented activities
            Research is the systematic and organized study of materials to come up with
new conclusions or to establish facts. It involves experimentation, and gathering and
analyzing data to solve a problem or reach a conclusion. Research involves identifying a
problem or topic, using appropriate methods to gather data, analyzing, and interpreting
data, and disseminating research results through publication and paper presentations.
In community-oriented activities, a BSMT/BSMLS can be involved in planning,
organizing, and leading institution- and/or hospital-based activities. The activities may
include blood sugar testing, routine urinalysis, routine stool examination, and other
basic laboratory tests with an end-in-view of improving quality of life of the target
community.
6.      be endowed with leadership skills
A leader sets the direction of a group for it to achieve its full potential while having a
consolidated vision toward the attainment of goals and objectives. A leader is someone
who has excellent communication skills, motivates and inspires others, and is not afraid
to develop others who may end up better than him or her.
No one is born a leader. Becoming an effective leader entails learning through
experiences that include failures inside and that include failures inside and outside the
academic and work environment.
7.      demonstrate collaboration, teamwork, integrity, and respect when working
in a multicultural environment
            Collaboration and teamwork are two important social skills necessary to work in
a
complex and, at times, multicultural environment like the clinical laboratory
Collaboration means working together with multiple individuals and finding a common
ground to work toward achieving a set goal. Likewise, working with others in a team
means working with people you disagree with but coming to terms with such
disagreements by sharing a common goal. It requires listening close paying attention to
what others contribute to the team.
 
 Employment opportunities for the graduates of the program
 
Job Opportunities for the Graduate of the Program
          A BSMT/BSMLS graduate can practice as a/an
·        Medical technologist/clinical laboratory scientist in a hospital-based or non-
hospital based clinical laboratory
·         Histotechnologist in an anatomical laboratory
·         Researcher/research scientist
·         Member of the academe (faculty, clinical instructor. clinical coordinator,
dean/ department chair, academic coordinator)
·          Perfusionist
·         Molecular scientist
·          Diagnostic product specialist
·          Public health practitioner
·          Health care leaders
 A graduate may also practice in the following fields
·         Molecular Biology
·         Public Health and Epidemiology
·          Veterinary Laboratory Science
·          Food and Industrial Microbiology
·         Veterinary Sciences
·          Forensic Science
·          Nuclear Medicine/Science
·         Health Facility Administration and Management
·          Quality Managements
 
 Unit 4 : NATURE OF THE CLINICAL LABORATORY
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. Seventy percent of all decisions
performed by doctors are based on laboratory test results, thus the need for accurate
and reliable results. The clinical laboratory is also actively involved in research,
community outreach programs, surveillance, and infection control in the hospital and
community settings, information and evaluation of the applicability of current and
innovative diagnostic technologies. Thus, the medical technologist/clinical laboratory
scientist serves as the integral er of medical doctors and is an important member of the
health care delivery system.
 
The clinical laboratory is the place where specimens (e.g., blood and other body fluids,
sues, 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.
 
A medical technologist/clinical laboratory scientist plays a very significant role in the
performance of laboratory testing and ensuring the reliability of test results. Assays
undertaken in the clinical laboratory in the past were described as manual, taxing, labor-
intensive, and time-consuming. Currently, with the advent of automation, assays are less
laborious, with shortened turnaround time (TAT). Also, test procedures are ensured to
produce more reliable results. In the near future, there will be more changes in the
clinical laboratory. Changes may be due to shifting demographics, emergence of new
and re-emergence of infectious and non-infectious diseases, demand for a more
efficient and effective workflow, and new government institutional policies. These
factors can usher in change in the activities done in the laboratory.
At the end of this unit, students will be able to:
  1.      Discuss the history of medical technology on a global context.
2.      Discuss the history of medical technology in the United States.
3.      Discuss the history of medical technology in the Philippines.
4.      Identify important personalities that played a significant role in the progress of
medical    
          technology profession.
5.      Discuss the historical milestones in Medical Technology.
Presentation of Contents
 
Clinical Laboratory
          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. Seventy percent of all decisions
performed by doctors are based on laboratory test results, thus the need for accurate
and reliable results. The clinical laboratory is also actively involved in research,
community outreach programs, surveillance, and infection control in the hospital and
community settings, information and evaluation of the applicability of current and
innovative diagnostic technologies. Thus, the medical technologist/clinical laboratory
scientist serves as the integral er of medical doctors and is an important member of the
health care delivery system.
            The clinical laboratory is the place where specimens (e.g., blood and other body
fluids, sues, 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.
            A medical technologist/clinical laboratory scientist plays a very significant role in
the performance of laboratory testing and ensuring the reliability of test results. Assays
undertaken in the clinical laboratory in the past were described as manual, taxing, labor-
intensive, and time-consuming. Currently, with the advent of automation, assays are less
laborious, with shortened turnaround time (TAT). Also, test procedures are ensured to
produce more reliable results. In the near future, there will be more changes in the
clinical laboratory. Changes may be due to shifting demographics, emergence of new
and re-emergence of infectious and non-infectious diseases, demand for a more
efficient and effective workflow, and new government institutional policies. These
factors can usher in change in the activities done in the laboratory.
 
Classifications 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
and 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 others. It is concerned with the diagnosis of diseases through microscopic
examination of tissues and organs.
 
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 over
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.
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, University of the Philippines Philippine General Hospital and local government
run hospital-based clinical laboratories of the Ospital ng Maynila Medical Center Sta.
Ana Hospital, and Bulacan 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, Makati Medical Center, and MCU-FDTMF Hospital
 
According to Service Capability
1. Clinical 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 that includes hemoglobin, hematocrit, WBC and
RBC count, WBC differential count and qualitative platelet count, blood typing, and
Gram staining (if hospital-based). Equipment requirements are, but not limited to,
microscopes, centrifuge, hematocrit centrifuge. 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 concentration,
blood urea nitrogen, blood uric acid, blood creatinine, cholesterol determination,
qualitative platelet count, and if hospital-based, Gram stain, KOH mount, and
crossmatching. A minimum requirement of 20 square meters is needed for the floor area
of this type of laboratory, Personnel requirement depends on the workload. Minimum
equipment requirements are microscopes, centrifuge, Hematocrit centrifuge,
semiautomated chemistry analyzers, autoclave, incubator, and oven.
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 plus (1) immunology and serology (e.g., NS1-Ag for rapid plasma
reagin, Treponema pallidum particle agglutination tests); microbiology, bacteriology,
and mycology (e.g., differential staining techniques, culture and identification of bacteria
and fungi from specimens, antimicrobial susceptibility testing); (3) special clinical
chemistry (e.g., clinical enzymology, therapeutic monitoring, markers for certain
diseases); (4) special hematology (e.g., bone marrow studies, special staining for
abnormal blood cells, red cell morphology); and immunohematology and blood banking
(e.g.. blood donation program, antibody identification, preparation of blood
components).
            Tertiary laboratories have a minimum floor area requirement of at least 60
square meters. Equipment requirements include those seen in secondary category
laboratories along with automated chemistry analyzer, biosafety cabinet class II,
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.
These functions include referral services, provision of confirmatory testing, assistance for
research activities, implementation of External Quality Assurance Programs (EQAP) of
the government, resolution of conflicts regarding test results of different laboratories,
and training of medical technologists on certain specialized procedures that require
standardization.
 
Laws on the Operation, Maintenance, and Registration of Clinical Laboratories in
the Philippines
Republic Act No. 4688
            An act regulating the operation and maintenance of clinical laboratories
and requiring the 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 authorized by the Secretary of Health, such authorization to be renewed
annually. No lice 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 s
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
Rules and Regulation Governing the Establishment, Operation and Maintenance of
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 E.O. 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 ensuring availability of clinical laboratories that are properly
managed with adequate 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
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
related tissue, 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
·         Clinical Pathology - includes Hematology, Clinical Chemistry, Microbiology,
Parasitology, Mycology, Clinical Microscopy, Immunology and Serology,
Immunohematology, Toxicology and Therapeutic Drug Monitoring and other similar
disciplines.
·         Anatomic Pathology - includes Surgical Pathology, Immunohistopathology,
Cytology, O Autopsy and Forensic Pathology. 2. Classification by Institutional Character
2.      Classification by Institutional Character
·         Hospital-based laboratory - a laboratory that operates within a hospital
·          Non-hospital-based laboratory - a laboratory that operates on its own
3.      Classification by Service Capability
·         Primary - provides the minimum service capabilities such as: (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 (2) Routine Urinalysis (3) Routine Fecalysis (4) Blood
Typing - hospital-based (5) Quantitative Platelet Determination - hospital-based
·         Secondary - provides the minimum service capabilities of a primary category and
following: (1) Routine Clinical Chemistry - includes Blood Glucose Substance Concentra
Blood Urea Nitrogen Concentration, Blood Uric Acid Substance Concentration, Blood
Creatinine Concentration, Blood Total Cholesterol Concentration (2) Crossmatching
·         Tertiary - provides the secondary service capabilities and the following: (1) Special
Chemistry (2) Special Hematology (3) Immunology/Serology (4) Microbiology
Section 6: Policies
1. An approved permit to construct and design layout of a clinical laboratory shall be
secured form the BHFS prior to submission of an application for a Petition to Operate
2. No clinical laboratory shall be constructed unless plans have been approved and
construction 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.
Section 7: Requirements and Procedures for Application of Permit to Construct and
License to Operate
1.      Application for Permit to Construct
 The following are the documents required:
·         Letter of Application to the Director of BHFS
·          Four (4) sets of Site Development Plans and Floor Plans approved by an architect
and/or engineer.
·         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 CHD.
a.       Renewal of License:
            Application for renewal of license shall be filed within 90 days before the expiry
date of the license described as follows:
 NCR January to March
1, 2, 3 & CAR February to April
4,5 & 6 March to May
7, 8 & 9 April to June
10, 11, 12, CARAGA & ARMM May to July
4.      Permit and License Fees
·         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.
·          A non-refundable fee shall be charged for application for renewal of license to
operate.
·          All fees shall be paid to the Cashier of the BHFS/CHD. Cud. All fees shall follow
the current prescribed schedule of fees of the DOH.
5.      Penalties
1.      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.
2.       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 monitored
regularly and records shall be made available to determine compliance with these rules
and regulations.
b. The Director of the BHFS/CHD or his authorized representative(s) shall be allow to
monitor the clinical laboratory at any given time. C. All clinical laboratories shall make
available to the Director of the BHFS or his duly authorized representative(s) records for
monitoring.
8.      Issuance of License
The license shall be issued by the Director of the CHD or his authorized representative if
the application is found to be meritorious.
9.      Terms and Conditions of License
o   The license is granted upon compliance with the licensing requirements.
o    The license is non-transferable.
o    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.
o    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.
o    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.
o    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. 4688 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.
o   Operation of a clinical laboratory without a certified pathologist or without a
registered medical technologist
o    Change of ownership, location, head of laboratory or personnel without informing
the BHFS and/or the CHD
o   Refusal to allow inspection of the clinical laboratory by the person(s) authorized by
the BHFS during reasonable hours
o    Gross negligence
o    Any act or omission detrimental to the public
3.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.
Section 9: Investigation of Charges or Complaints
The BHFS/CHD or his duly authorized representative(s) shall investigate the complaint
and verify 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 of the offending person(s), without prejudice to taking
the case to judicial authority for criminal action.
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 P5,000.00 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 penalty imposed herein.
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.
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.
Section 10: Modification and Revocation of License
1.      A license maybe revoked, suspended or modified in full or in part for any material
false 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 cases of 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.
Section 13: Effectivity
            These rules and regulations shall take effect 15 days after its publication in the
Official c. or in a newspaper of general circulation.
 
ANNEX A
Technical Standards and Minimum Requirements
          The clinical laboratory shall be organized to provide effective and efficient
laboratory services.
a.       STAFFING
1)      The clinical laboratory shall be managed by a licensed physician certified by the
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. The BHFS shall certify such
training.
2)      The clinical laboratory shall employ qualified and adequately train personnel.
 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.
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.
II. PHYSICAL FACILITIES
·         The clinical laboratory shall be well-ventilated, adequately lighted, clean and safe.
·          The working space shall be sufficient to accommodate its activities and allow for
smooth and coordinated work flow.
·          There shall be an adequate water supply.
·          The working space for all categories of clinical laboratories (both hospital and
non-hospital-based) shall have at least the following measurements:
Primary 10 sqm
            Secondary 20
            Tertiary 60
III. EQUIPMENT/INSTRUMENTS
·         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.
·          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. (Copies of which are
available at respective CHDs and DOH-BHFS and local government offices)
VI. QUALITY CONTROL PROGRAM
All clinical laboratories shall have a functional Quality Assurance Program
1. Internal Quality Control Program
o   There shall be a documented, continuous competency assessment program for all
laboratory personnel.
o    The program shall provide appropriate and standard laboratory methods, reagents
and supplies and equipment.
o    There shall be a program for the proper maintenance and monitoring of all
equipment.
o    The program shall provide for the use of quality control reference materials.
2. External Quality Control Program
o   All clinical laboratories shall participate in an External Quality Assurance Program
given by designated National Reference Laboratories and/or other recognized reference
laboratories.
o    A satisfactory performance rating given by a National Reference Laboratory shall be
one of the criteria for the renewal of license.
o    Any refusal to participate in an External Quality Assurance Program the designated
National Reference Laboratories shall be one of the suspension/revocation of the license
of the laboratory.
VII. REPORTING
            Laboratory requests shall be construed as consultation between the physician
and the Pathologist of the laboratory and as such laboratory results released
accordingly.
·         All laboratory reports on various examinations of specimens shall bear the sign of
the registered medical technologist and the Pathologist and duly sign both.
·          No person in the clinical laboratory shall issue a report, orally or in writing whole
or portions thereof without a directive from the Pathologist 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.
·         There shall be an adequate and effective system of recording requests and reports
of all specimens submitted and examined.
·          There shall be provisions for filing, storage and accession of all reports.
·         All laboratory records shall be kept on file for at least one (1) year. a. Records of
anatomic and forensic pathology shall be kept permanently in the laboratory.
 
IX. LABORATORY FEES
The laboratory and professional fees to be charged for laboratory examination shall be
at the prevailing rates.
·         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.
·          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.
 
Sections of the Clinical Laboratory
            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. At the forefront of these
activities are the clinical laboratory namely the pathologists, medical
technologists/clinical laboratory scientists, phlebotomists, and other laboratory
personnel.
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 fasting blood
sugar (FBS) and glycosylated hemoglobin (HbA1c) for the diagnosis of diabetes; total
cholesterol including high- and low density lipoproteins (HDL and LDL); triglycerides
(TAG) that can be used for the diagnosis of cardiovascular diseases; blood uric acid
(BUA); blood urea nitrogen (BUN); creatinine for diagnosis of diseases involving the
kidney; total protein (TP); albumin; electrolytes (e.g., Sodium, Potassium, Chloride);
clinical enzymology (e.g., aminotransferase, creatinine kinase, etc.).
            In terms of the number of tests performed, this section is considered to be one
of the busiest. In majority of tertiary level clinical laboratories, this section is
characterized as a state-of-the-art, fully automated facility. In some laboratories,
hormone in the blood and urine are also measured under endocrinology. Thyroid
hormones tests include thyroid stimulating hormone (TSH), T3 and T4 (triodothyronine
and thyroxine, respectively); other tests involving estrogen, prolactin, and testosterone.
Other laboratories also have Toxicology and Drug Testing sections where therapeutic
drug monitoring tests for prohibited drugs are performed.
            Internal Quality Assurance (IQA), Continuous Quality Improvement (CQA), and
participation in National External Quality Assurance Program (NEQAP) are important
activities that medical technologists perform and are responsible for.
Microbiology
            This section is subdivided into four sections: bacteriology, mycobacteriology,
myco 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.
            Tests include the microscopic visualization of microorganisms after staining,
isolation and identification of bacteria (aerobes and anaerobes) and fungi using varied
culture media and different biochemical tests, and at times, antigen typing, and
antibacterial susceptibility testing. Other activities performed in this section include the
preparation of culture media and stains, quality assurance and control, infection control,
and biosafety and proper waste disposal. Mycobacteriology looks into the identification
of mycobacterium (e.g.- Mycobacterium tuberculosis) from the specimens submitted.
Although not as automated as clinical chemistry, automated instruments are available
such as those used for blood culture and antimicrobial susceptibility testing.
Hematology and Coagulation Studies
                        This section deals with the enumeration of cells in the blood and other body
fluids (e.g-CSF, pleural fluid, etc.). The examinations done in this section include
complete blood count globin, hematocrit, WBC differential count, red cell morphology
and cell indices, quantitative platelet count, total cell count and differential count, blood
smear preparation, for other body fluids. Coagulation studies focus on blood testing for
the determination of various coagulation factors.
            There are also developments and innovations that contribute to the automation
of activities in this section. Automated hematology analyzers are currently available in
the market. Bone marrow examination using automated analyzers is also conducted in
this section.
 
Clinical Microscopy
            There are two major areas in this section of the laboratory. The first area is a to
routine and other special examinations of urine such as macroscopic examination:
determine color, transparency, specific gravity, and pH level, and microscopic
examination detect presence of abnormal cells and/or parasites as well as to quantify
red cells and a and other chemicals found in urine. Examination of other body fluids is
also performed area. The second area is assigned to the examination of stool or routine
fecalysis. Determination 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 ion. Screening for all antibodies and identification of antibodies as well as the blood
components used for transfusion are also conducted in this section. This section is
considered as the most critical in the clinical laboratory.
            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
performed in this section. Hepatitis B profile tests, serological tests for syphilis, and
hepatitis C and dengue fever are some examples of antibody screening tests. Similar to
Chemistry and Hematology sections, automated analyzers are commonly used in this
when performing different serological tests.
 
Anatomic Pathology
Section of Histopathology/Cytology
            Activities performed in this section include tissue (removed surgically as in bi and
autopsy) processing, cutting into sections, staining, and preparation for micro
examination by a pathologist.
Specialized Sections of the Laboratory
Immunohistochemistry
            It is a specialized section of the laboratory that combines anatomical, clinical,
and 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. It can also be used to assess
the responses of patients to cancer therapy as well as diagnosis of certain
neurodegenerative disorders.
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). This technique has contributed to scientific advancements in laboratory
research and is useful for a number of clinical techniques such as screening genetic
indicators of disease and diagnosis of cancer and infectious diseases.
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, transport and processing of specimen to the
clinical laboratory. The analytic phase the actual testing of the submitted/collected
specimen. Important consideration should be given to equipment and instruments used,
reagents, and internal quality control. The post-analytic phase includes the transmission
of test results to the medical doctor for interpretation, TAT, and application of doctor's
recommendations. The diagnosis and treatment are based on the generated data.
            Medical technologists/clinical laboratory scientists should have a clear
understanding of this testing cycle in order to prevent erroneous test results. In the pre-
analytic phase, variables that may affect the test results are present in the preparation of
the request slip for the patient until the sample is transported to and processed in the
clinical laboratory. Some of the variables that may cause errors are physiologic factors,
diet, medications, alcohol and caffeine intake, exercise, underlying disease conditions,
identification of patients and labeling of specimens, anticoagulant used, and volume of
specimen collected vis-à-vis volume of anticoagulant. The major sources of variables
under the analytic phase are equipment and instruments, quality of reagents used, and
internal quality control program. The post-analytic phase looks into the control of the
variables of TAT and transcription errors (e.g., wrong value used, results given to the
wrong patient).
 
Quality Assurance in the Clinical Laboratory
            Quality assurance (QA) encompasses all activities performed by laboratory
personnel to ensure reliability of test results. It is organized, systematic, well-planned,
and regularly done with the results properly documented and consistently reviewed.
            Quality assurance in the clinical laboratory has two major components: Internal
Quality Assurance System (IQAS) and External Quality Assurance System (EQAS). IQAS
includes 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
weaknesses and consequently perform corrective actions. EQAS, on the other hand, is a
system checking performance among clinical laboratories and is facilitated by
designated a agencies. The National Reference Laboratories (NRL) is the DOH-
designated FOA unknown sample with known test results is regularly sent to a clinical
laboratory for to Results are then returned to the external facility and are compared with
the known This procedure determines the performance of the laboratory. A certificate of
performance given to the participating clinical laboratory.
At present, the designated NRL-EQAS are the following:
•         National Kidney and Transplant Institute (NKTI) - Hematology and Coagulation
•         Research Institute of Tropical Medicine (RITM) - Microbiology (identification and
antibiotic susceptibility testing) and Parasitology (identification of ova quantitation of
malaria)
•         Lung Center of the Philippines (LCP) - 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 (EAMC) - Drugs of abuse (methamphetamine and
cannabinoids)
•         San Lazaro Hospital STD-AIDS Cooperative Center Laboratory (SACCL) - Infectious
immunology hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV),
hepatitis C virus (HCV)
 Unit 5: PROFESSIONAL ETHICS AND VALUES: MORAL IMPLICATIONS
Introduction
In the practice of medical technology, it is imperative to know how to observe,
professional ethics while interacting with colleagues, patients, and other significant
members of the healthcare team. It is difficult to distinguish what is ethical from the
point of one's norms and values and within the standard norms and values of society.
Every medical technologist is asked to perform medical research and treatment
procedures within the bounds of what is ethical, and accept the legal consequence and
moral implications.
 KEY TERMS
 Bioethics: A branch of science that deals with the study of the morality of human
conduct concerning human life in all its aspects from the moment of conception to its
natural end.
 Ethics: A philosophical and practical science that deals with the study of the morality of
human acts or human conduct.
Malpractice: An intentional act of professional negligence by a healthcare provider, in
which care provided deviates from accepted standards of practice in the medical
community and may cause injury or death to the patient.
Medical data breach: The intentional and unintentional disclosure of medical records
without the consent of the patient.
Medical ethics: A field of applied ethics that studies moral values and judgments as they
apply to medicine.
Morality: A system of ideas and/or beliefs on good (right) or evil (wrong).
Negligence: A general term denoting conduct lacking in due care.
Professional ethics: A branch of moral science that deals with the obligations that a
member of a profession owes to the public, the profession, and his/her clients.
Values: The beliefs that guide peoples' thoughts and Value development: It is a product
of human interaction with the cultural environment.

Learning Outcomes
At the end of this unit, students will be able to:
1.    Discuss professional ethics.
2.    Recognize and appreciate the Medical Technology ethics and values.
 
 Medical Technology Ethics and Values
Ethical problems associated with medical practice bioscience fall within the scope of
medical technology. Ethics does not only deal with patient-physician relationships from
a moral point of view, but extends to social issues to health, animal welfare, and
environmental concerns.
           
Types of Ethics
General Ethics
This type of ethics presents truths about human acts, from which the general principle
of morality is deduced.
 
Special Ethics
This involves the application of the principles of general ethics in different departments
of human activity both at the individual and social levels. Special ethics can be further
divided into individual ethics, which are concerned with God, self, and fellow human
beings; and social ethics, which are concerned with family, the state, and the world.
 
Professional Ethics
Professional ethics is a branch of moral science that deals with how and what a
professional should or should not do in the workplace. It addresses the question, "What
should I do in this situation?" Professional ethics are intended to bind professions more
tightly together around a shared standard of values. A professional has obligations to
his profession, to the public, and to his or her clients. Moral issues may sometimes arise
in the workplace. Knowledge on professional ethics can guide staff in analyzing
assumptions and arriving at ethical decisions.
            A professional who observes professional ethics is exemplified by a person who
observes appropriate conduct and behavior while carrying out his work. This conduct
and behavior should be adopted in all dealings for the good of the community and
humankind.
Code of Professional Ethics
            The objectives of professional ethics:
1.  Perform duties and responsibilities objectively in accordance with relevant standards
and guidelines.
2. Serve in a lawful and honest manner, while maintaining high standards of conduct
and character and not engage in acts discreditable to the profession.
3. Maintain the privacy and confidentiality of information obtained in the course of duty
unless disclosure is required by a legal authority. Such information should not be used
for personal benefit or released to inappropriate parties.
4. Perform tasks with full confidence, absolute reliability, and accuracy.
5. Be dedicated to the use of clinical laboratory science to promote life and for the
benefit of mankind.
 
Medical Ethics
This is a field of applied ethics that studies moral values and judgments as they apply to
medicine. Medical ethics are a set of norms, values, and principles that serve as
guidelines for medical practitioners-such as physicians, nurses, medical technologists
and other associated professionals in making decisions in clinical settings. Moral values
are based on various sources such as religion, philosophy, professional codes,
professional associations, family, culture, community, colleagues, and personal
experience. Medical ethics can affect the well-being of patients and even the medical
practioner's professional and personal lives. Medical professionals have to deal with
daily ethical dilemma in clinical settings because the community relies on critical
decisions made in time, which sometimes have far-reaching consequences.
 
Moral Principles in Medical Technology Ethics
Autonomy. This principle dictates that the patient has the right to refuse or choose
their treatment.
Beneficence. This principle indicates that a practitioner should act in the best interest of
the patient.
Nonmaleficence. This principle provides that evil or harm should not be inflicted either
on oneself or on others.
Justice. This principle is concerned with the distribution of scarce health resources and
the decision on who gets what treatment in terms of fairness and equality.
Respect for Dignity. This principle provides for all the necessary means of care, high
regard for the person or the patient, and needed information to make a relevant
decision.
Truthfulness and Honesty. This is simply the dedication of a person to his job and is
reflective of being honest and concerned.
Stewardship. This principle refers to the expression of one's responsibility to nurture
and cultivate what has been entrusted to him.
 
VALUES OF A MEDICAL TECHNOLOGIST
A person's beliefs are influenced by one's family, community, society, culture, religion,
and colleagues. These factors shape one's values and behavior. The values of a person
are not constant; they change over time. Aside from the values that are inherent in an
individual, other values can also be developed. An inherent personal value motivates a
person to choose what is good for oneself, and becomes the basis for one's interest in
doing what is right. Personal values are developed from life experiences.
A child who cannot support himself/herself needs the care of the family in order to
survive. A family, which is the basic unit of a society, is governed by unconditional love
and trust that protects the interests of each family member. Because of strong family
ties, family values have strong influence on a person's belief and behavior. Similarly, the
community to which an individual belongs can also shape the cultural values of a
person. It sets the standards that are acceptable in the society which defines the way of
life in the community. American values are different from Asian values; and within Asia,
Korean values are different from Filipino values. When an individual moves to another
country, an adjustment to the cultural values of his new place is needed to get along
with the citizens of that place. People within the community belong to different religious
organizations that have different faith and spirituality. Spiritual values are based on
religious values that emanate from God.
An individual is usually governed by the combination of these values. Conflict between
these values creates problem as one value contradicts another value. The conflict of
values causes confusion on the right thing to do in a particular situation.
The values of an employee are important to keep order within the workplace. A code of
conduct, which defines the expected behavior of an employee, is set within the
workplace. In a professional setting, values and ethics serve as the foundation of an
organization. Within the workplace, professionals have different values, attitudes,
backgrounds and skills, so there is a need for a common work ethic. This is important in
achieving a common goal. Some of the employee's work values are punctuality,
integrity, commitment, honesty, and loyalty.
The practice of medical technology consists of engaging in activities to conduct analysis
and tests in the field of medical biology on the human body or on a specimen, and to
ensure the technical validity of the results for diagnostic or therapeutic follow-up
purposes. A medical technologist is accountable to the patient, to the attending
physician and to the community in general. This means that the medical technologist
takes on the responsibility of providing accurate and reliable test results.
The medical technologist works collaboratively with the medical practitioner in
providing patient care through accurate diagnosis and treatment. The commitment to
provide prompt and professional service is important in efficient healthcare delivery.
Integrity in laboratory management is needed in quality assurance. The medical
technologist review records in compliance with clinical guidelines in specimen
diagnostic assay, and data collection. The obligation the confidentiality of all laboratory
test results and information is a sign of respect to the right of patient for privacy.
 
The Profession of Medical Technologists
Primarily, medical technologists should carry out their duties conscientiously and take
responsibility for their own actions.  A medical technologist obeys the instructions and
directions of the management. However, if it conflicts with the conviction fundamental
principles of the profession, they have the right to turn down work that affects its quality
and control. Being in the profession, they should pay attention to the risk of contagion
hygiene, and the external environment. Medical technologist should keep abreast of the
latest advancements in their field of education and continue enhancing their
professional skills.
As in other medical professions, mistakes in the practice of medical technology are
sometimes inevitable and can lead to ethical dilemmas. In this situation, the medical
technologists’ code of ethics serves as the guidelines for making the appropriate
decision. However, not all medical technologists will arrive at the same decision even
though the same ethical principles are applied. Nevertheless, a high level of integrity
should be maintained in dealing with ethical dilemmas.
 
Medical Technologists and Patients
Patients' rights include the right to be treated with dignity, the right to self-
determination and the right to not be harmed or hurt. People are entitled to protect
their own identity and individuality. Within the bioethical sphere, the patient has a right
to participate in the decision-making process along with professionals, especially if it
pertains to the patient’s own welfare and condition. It is, therefore, the duty of the
professionals to respect the patient's decision. At the same time, the Medical
technologist should clearly inform the patient possibilities and limitations of the
treatment prescribed aim of explaining the risks in treatment and trials is to gain
cooperation from the patient consent prior to the trials.
 
Because of the advancements in technology, medical data breach has become a
pressing issue for the medical profession. Confidentiality in the field of medicine is
about protecting the patient's information and medical results. Negligence on the part
of medical technologists to safeguard the security of the patient record will jeopardize
patient privacy. Because of this, lack of trust in the medical field has become a growing
problem in the healthcare system.
           
Medical Technologists and Their Colleagues
Medical technologists should respect the work of their colleagues and support them
professionally. They must exhibit tolerance toward other professionals work methods
and circumstances. Supportive behavior promotes health and safety in the work
environment.
 
Medical Technologists and Their Workplace
Ethics are rules and values used in a professional setting. In the workplace, managers
and supervisors set standards or ethics to show respect and honesty as well as to
promote trust. If the team uses unethical forms of communication, the organization
cannot succeed. Ethics are used worldwide in small or large companies, including
hospitals. Ethics in the workplace promotes a sense of worth and trust among
professionals. Medical technologists are expected to make their knowledge available to
other medical technologists, biomedical students, and other members of the healthcare
team. They should be respectful of their responsibility and other professional disciplines
and work toward establishing and building cooperation with other professionals. Thus,
patients will benefit. The medical technologists will also contribute toward improving
public healthcare service as well the utilization of resources. The clients trust that the
services provided by the professionals will benefit them.
 
Medical Technologists and the Society
Medical technologist should keep themselves informed of the developments and
changes in biomedical and political healthcare legislations. They should also ensure that
all biological materials be disposed in an ethical and environmentally safe manner.
Problems and Concerns in Medical Technology Practice
Negligence
This means failure to act and use reasonable care. Anyone, including nonmedical
persons, can be liable for negligence. Negligence involves carelessness and deviation
from the expected standard of care in a particular set of circumstances.
 
Malpractice
This is an act of negligence or omission of a healthcare service expected from a
professional healthcare provider in which the care provided deviates from accepted
standards of practice in the medical community and may result in injury or death of the
patient. Malpractice is a more specific term that pertains to both the standard of care
and professional status of the healthcare provider. If the person committing the wrong
deed is a professional, then he or she is liable for malpractice.
 
In order to prove negligence or malpractice, the following elements must be
established: a duty is owed, which means that a legal duty exists whenever a hospital or
healthcare provider undertakes care or treatment of a patient; a duty was breached,
which means that the healthcare provider failed to conform to the relevant standard of
care; the breach causes an injury, which means that the breach of duty was the
proximate cause of injury; and damages that may be economic (lost earning capacity,
medical expenses, and so on) and noneconomic damages, including physical damage
such as loss of vision, organ, and Limbs and psychological damage such as severe pain
and emotional distress.
 Unit 6: MEDICAL TERMINOLOGIES AND ABBREVIATIONS
Introduction
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 be familiar with the abbreviations
and meanings of common medical terms. This unit includes some of  the common
medical terminologies and their meaning,
Also included are the rules on the appropriate letter that comes after a suffix, how to
convert a medical term from its singular form to its plural form.

Learning Outcomes
  At the end of this unit, students will be able to:
1.      Identify the meaning of the root word,  prefixes and suffixes commonly used in
medical 
         terminologies;
2.      Use correctly commonly used  prefixes and suffixes;
3.      Define meaning of common medical terms used in the practice of medical
technology.
 
Presentation of Contents
A medical term has three basic parts-the root word, the prefix, and the suffix. The root
word is the main part of the medical term that denotes the meaning of the word.
Examples:       colo - colon
 hemat – blood
              phlebo - vein
   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
 hyper-- meaning increased/above
 poly-- many pre—before
 
            On the other hand, 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
   -uria - urine 
   -ostomy - to make an opening or mouth
 
            It is a rule that if the suffix starts with a consonant, a combining vowel needs to
be used (usually the letter O). The combining vowel does not change the meaning of the
root word and is added in order to make the pronunciation of the word easier. The
combining vowel is added between the root word and the suffix. Examples:
hemat + logy = hematology - study of blood
phlebo + tomy - phlebotomy - the process of cutting into the vein using a needle.
 
            The plural form of medical terms is made by changing the end of the word and
not by simply adding S, which follows the rule for irregular nouns.
Examples:
bacterium bacteria
nucleus nuclei
thrombus thrombi
bacillus bacilli
 
Root Words
cardio = heart myo = muscle arterio = arterys cyto = cell
arthro = joint
heap/hepato = liver pyo = pus cranio = skull
pyro = fever  nephro = kidney
osteo = bone
 
Prefixes
iso- = same micro- = small macro- = large intra- = inside/within
pseudo- = false
anaero- = without oxygen mono- = one
homo- = same, like nano- = billionth
cryo- = cold hypo- = decreased logamning neo-= new
 
Suffixes
-itis = inflammation of -megaly = enlargement -blast = young -cidal = killing of
-poiesis = formation
pathy = disease -meter = measure  -penia = deficiency -ectomy = surgical removal oma
= tumor
 -emia = blood condition to -tome = cutting instrument
 
Abbreviations
Listed below are the commonly encountered abbreviations in the health care practice
that medical technology students should know:
DOH - Department of Health
CHED - Commission on Higher Education 
VDRL - Venereal Disease Research Laboratories
AIDS - Acquired Immunodeficiency Syndrome
AIDs - Autoimmune disorders/diseases
AMI - Acute Myocardial Infarction
BUN - Blood Urea Nitrogen
2PPBS - 2 hours Postprandial Blood Sugar
AFS - Acid Fast Stain
PCQACL - Philippine Council for Quality Assurance in the Clinical Laboratories
FBS - Fasting Blood Sugar
IV - Intravenous
HIV - Human Immunodeficiency Virus
IU - International Unit
ICU - Intensive Care Unit
K - Potassium
Na - Sodium
NPO- Nothing Per Orem
BAP - Blood Agar Plate
 
 Unit 7: LABORATORY BIOSAFETY AND BIOSECURITY
Good biosafety, laboratory biosecurity and biocontainment practices are fundamental to
public health. Perhaps the failure to follow appropriate biosafety and laboratory
biosecurity practices may still be the greatest threat for the reappearance of SARS.
Likewise, biosafety, laboratory biosecurity and biocontainment practices are crucial for
the safekeeping of poliovirus within laboratories as laboratories and culture collections
become the only repositories of the wild poliovirus. The continuing implementation of
appropriate biosafety, laboratory biosecurity and biocontainment practices is essential
to prevent the release of variola viruses from the two custodial repositories (CDC,
Atlanta, GA, USA, and VECTOR, Koltsovo, Novosibirsk Region, Russian Federation),
where research on these viruses is carried out.
 
Responsible laboratory practices, including protection, control and accountability for
valuable biological materials will help prevent their unauthorized access, loss, theft,
misuse, diversion or intentional release, and contribute to preserving scientifically
important work for future generations.
 
Learning Outcomes
At the end of this unit, students will be able to:
  1.      Discuss the history and the related policies and guidelines governing laboratory
biosafety and biosecurity.
2.      Classify microorganisms according to risk group.
3.      Categorize laboratories according to biosafety level.

Presentation of Contents
 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).
            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. After the Second World War, Camp Detrick was designated a
permanent installation for biological research and development. Biosafety was an
inherent component of biological weapons development. Later on, Newell A. Johnson
designed modifications for biosafety at Camp Derrick. He engaged some of Camp
Detrick's leading scientists about the nature of their work, and developed specific
technical solutions such as Class III safety cabinets and laminar flow hoods to address
specific risks. Consequent meetings eventually led to the formation of the American
Biological Safety Association (ABSA) in 1984. The association held annual meetings that
soon became the ABSA annual conferences (Salerno et al., 2015).
            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.
            At the height of increasing mortality and morbidity due to smallpox in 1967,
WHO aggressively pursued the eradication of the virus (College of Physicians of
Philadelphia 2014). It was also during this time that serious concerns about biosafety
practices worldwide were raised, contributing directly to the decision of the World
Health Assembly to consolidate the remaining virus stocks into two locations: the Center
for Disease Control and Prevention (CDC) in the United States and the State Research
Center of Virology and Biotechnology VECTOR (SRCVB VECTOR) in Russia. In 1974, the
CDC published the Classification of Etiological Agents on the Basis of Hazard, that
introduced the concept of establishing ascending levels of containment associated with
risks in handling groups of infectious microorganisms that present similar
characteristics. Two years later, the National Institutes of Health (NIH) of the United
States published the NIH Guidelines for Research Involving Recombinant DNA
Molecules. It explained in detail the microbiological practices, equipment, and facility
necessarily corresponding to four ascending levels of physical containment.
            These guidelines laid the foundation for the introduction of a code of biosafety
practice. The code, along with WHO's first edition of Laboratory Biosafety Manual (1983)
and the NIH's jointly-published first edition of the Biosafety in Microbiological and
Biomedical Laboratories (1984), marked the development of the practice of laboratory
biosafety These documents established the model of biosafety containment levels with
certain agents which increased the biosafety levels for biological agents that pose risks
to human health. Bi levels are the technical means of mitigating the risk of accidental
infection from or of agents in the laboratory setting as well as the community and
environment it is sit in. Although biosafety levels are concentrated in a combination of
engineered con administrative controls, and practices, the emphasis is clearly on the
equipment and facility controls, with little attention given to risk assessment.
            This progress in biosafety practice continued until the emergence of a
community of "biosafety officers" who adopted the administrative role of ensuring that
the proper equipment and facility controls are in place based on the specified biosafety
level of the laboratory.
            Arnold Wedum, director of Industrial Health and Safety at the US Army
Biological Research Laboratories in 1944, was recognized as one of the pioneers of
biosafety that provided the foundation for evaluating the risks of handling infectious
microorganisms and for recognizing biological hazards and developing practices,
equipment, and facility safeguards for their control. In 1966, Wedum and microbiologist
Morton Reitman, colleagues at Fort Detrick, analyzed multiple epidemiological studies
of laboratory-based outbreaks.
 
Brief History of Laboratory Biosecurity
            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.
            The revision of the Select Agent Regulations in 2012 sought to address the
creation of two tiers of select agents. Tier 1 agents are materials that pose the greatest
risk of deliberate misuse, and the remaining select agents. This change was intended to
make the regulations more risk-based, mandating additional security measures for Tier
1 agents. Other countries also relatively implemented and prescribed biosecurity
regulations for bioscience facilities. Singapore's Biological Agents and Toxins Act is
similar in scope with the US regulations but with more severe penalties for
noncompliance (Republic of Singapore 2005). In South Korea, the Act on Prevention of
Infectious Diseases in 2005 was amended to require institutions that work with listed
"highly dangerous pathogens” to implement laboratory biosafety and biosecurity
requirements to prevent the loss, theft, diversion, release, or misuse of these agents. In
Japan, the Infectious Disease Control Law was recently amended under Japan's Ministry
of Health, Labor, and Welfare. It also established four schedules of select agents that are
subject to different reporting and handling requirements for possession, transport, and
other activities.  Then in Canada, Canadian containment level (CL) 3 and CL4 facilities 
that work with risk group 3 or 4 are required to undergo certification. In 2008, the
Danish Parliament passed a law that gives the Minister of Health and Prevention the
authority to regulate the possession, manufacture, use, storage, sale, purchase or other
transfer, distribution, transport, and disposal of listed biological agents. Around the
world, biosecurity implementation has become a purely administrative activity based on
a government developed checklist.
 
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 CW 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 24 different countries including Argentina, Australia,
Belgium, Canada, China, Denmark, Germany, 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).
            To address concerns on biosafety guidance for research and health laboratories,
issues on risk assessment and guidance to commission and certify laboratories, the
WHO in 1983 published its 3rd edition of the Laboratory Biosafety Manual. It includes
information on the different levels of containment laboratories (Biosafety levels 1-4),
different types of biological safety cabinets, good microbiological techniques, and how
to disinfect and sterilize equipment. In terms of biosecurity, it covers the packaging
required by international transport regulations and other types of safety procedures for
chemical, electrical, ionizing radiation, and fire hazards. The manual puts emphasis on
the continuous monitoring and improvement directed by a biosafety officer and the
biosafety committee. Unfortunately, there is no mechanism to ensure that the WHO
biosafety guidance is being adhered to, or that people working in laboratories are
sufficiently trained.
            The Cartagena Protocol on Biosafety (CPB), made effective in 2003 which applies
to the 168 member-countries provides an international regulatory framework to ensure
"an adequate level of protection in the field of safe transfer, handling, and use of living
modified organisms (LMOs) resulting from modern biotechnology." The regulations
primarily tackle the safe transfer, handling, and use of LMOs that may have adverse
effects on the conservation of biological diversity except those that are used for
pharmaceuticals purposes. In addition legislation provides a framework for assessing the
risk of LMOs and is focused on that LMOs do not negatively affect biodiversity.
            The new National Committee on Biosafety of the Philippines (NCBP) established
E.O. 430 series of 1990 was formed on the advocacy efforts of scientists. The man NCPB
focuses on the organizational structure for biosafety: procedures for evaluating
proposals with biosafety concerns; procedures and guidelines on the introduction, move
and field release of regulated materials, and procedures on physico-chemical and
biological containment. On March 17, 2006, the Office of the President promulgated E.O
establishing the National Biosafety Framework (NBF), which prescribes the guidelines for
implementation, strengthening the National Committee on Biosafety of the Philippines
NBF is a combination of policy, legal, administrative, and technical instruments
developed attain the objective of the Cartagena Protocol on Biosafety which the
Philippines signed on May 24, 2000. The NBF can be considered as an expansion of the
NCBP, which since 1989 has played an important role in pioneering the establishment
and development of the current biosafety system of the country and was acknowledged
as a model system for developing countries. The Department of Agriculture (DA) also
issued Administrative Order No. 8 t set in place policies on the importation and release
of plants and plant products derived from modern biotechnology. The Department of
Health (DOH), together with NCBP, formulated guidelines in the assessment of the
impacts on health posed by modern biotechnology and its applications. The guidelines
aid in evaluating and monitoring processed food derived from or containing GMO.
Currently, DOH, in the midst of technological advances, recognizes the need to update
the minimum standards and technical requirements for clinical laboratories. It requires
clinical laboratories to ensure policy guidelines on laboratory biosafety and biosecurity
(DOH Administrative Order No. 2007-0027).
 
Different Organizations in the field of Biosafety
            Several organizations across continents have undertaken initiatives in advocating
for laboratory biosafety and biosecurity. The following are some prominent
organizations inside and outside the Philippines:
1.      American Biological Safety Association (ABSA) a regional professional society for
biosafety and biosecurity founded in 1984. It promotes biosafety as a scientific O
discipline and provides guidance to its members on the regulatory regime present in
North America.
2.      Asia-Pacific Biosafety Association (A-PBA) a group founded in 2005 that acts as a
professional society for biosafety professionals in the Asia-Pacific region. Its members E
are from Singapore, Brunei, China, Indonesia, Malaysia, Thailand, the Philippines, and
Myanmar. Active members of the International Biosafety Working Group are be required
to directly contribute to the development of the best biosafety practices.
3.      European Biological Safety Association (EBSA) a non-profit organization to in June
1996, that aims to provide a forum for discussions and debates on issue sent those
working in the field of biosafety. EBSA focuses on encouraging and communicating
among its member’s information and issues biosafety and biosecurity as well as
emerging legislation and standards.
4.      Philippine Biosafety and Biosecurity Association (PhBBA) created by a multi-
disciplinary team with members coming from the health and education sector's as well
as individuals from the executive, legislative, and judicial branches of government. Also
included are members of the steering committee and technical working groups of the
National Laboratory Biosafety and Biosecurity Action 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.
5.      Biological Risk Association Philippines (BRAP) a non-government and non-profit
association that works to serve the emergent concerns of biological risk management in
various professional fields such as in the health, agriculture, and technology sectors
throughout the country. It has launched numerous activities in cooperation and
collaboration with other associations, on a national and international scale in the
promotion of biosafety, biosecurity, admittance to authorized personnel only and
biorisk management as scientific disciplines. BRAP goes by the tagline, "assess, mitigate,
monitor."
 
            Currently, member countries of ABSA, A-PBA, and EBSA have founded
organizations in their respective nations which share the same goals and objectives in
addressing issues and concerns related to biosafety and sign for laboratory doors
biosecurity.
 
Fundamental Concepts of Laboratory Biosafety and Biosecurity
            WHO issued a common understanding of biosafety derived from the practical
guidance on techniques to be used in laboratories. Biosafety has long been practiced in
most nations especially among institutions that handle and process microbiological
specimen. The WHO Laboratory Biosafety Manual (LBM) defines biosafety as "the
containment principles, technologies, and practices that are implemented to prevent
unintentional exposure to pathogens and toxins, or their accidental release." On the
other hand, biosecurity refers to "the protection, control, and accountability for valuable
biological materials laboratories, in order to prevent their unauthorized access, loss,
theft, misuse, diversion or intentional release" (WHO, 2006). By simple definition,
"biosafety protects people for germs" while "biosecurity protects germs from people."
            In 1966, Charles Baldwin, an environmental health engineer working for the Dow
Chemical Company containment systems products, created the biohazard symbol used
labeling biological materials carrying significant health risks.
            Biosafety and biosecurity share common perspectives in terms of risk assessment
and management methodologies, personnel expertise and responsibility, control and
accountability for research materials including microorganisms and culture stocks,
access control elements, material transfer documentation, training, emergency planning,
and program management among others.
            To sum up, biosafety focuses on laboratory procedures and practices necessary
to prevent exposure to and acquisition of infections while the maintenance of secure
procedures and practices in handling biological materials and sensitive information falls
under biosecurity.
 
Classifications of Microorganisms According to Risk Groups
            WHO recommends an agent risk group classification for laboratory use that
describes four general risk groups based on principal characteristics and relative hazards
posed by infectious toxins or agents. 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. Through the classification,
infective microorganisms are classified as Risk Group 1, Risk Group 2, Risk Group 3, and
Risk Group 4:
1.      Risk group 1 - includes microorganisms that are unlikely to cause human or animal
disease. These microorganisms bring about low individual and community risk.
2.       Risk group 2 - includes microorganisms that are unlikely to be a significant risk to
laboratory workers and the community, livestock, or the environment. 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.
3.       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. It could
present a limited to moderate risk if these microorganisms spread in the community or
the environment, but there are usually effective preventive measures or treatment
available. They bring about high individual risk, and limited to moderate community risk.
4.       Risk group 4 - includes microorganisms that are known to produce life-
threatening diseases to humans or animals. It represents a significant risk to laboratory
workers and may be readily transmissible from one individual to another while effective
treatment and preventive measures are not usually available. In effect, they bring about
high individual and community risk.
 
Categories of Laboratory Biosafety According to Levels
            In order to facilitate precautionary measures, CDC categorized laboratories into
four biosafety levels-Biosafety Level 1, Biosafety Level 2, Biosafety Level 3, and Biosafety
Level 4. Biosafety level designations are based on a composite of the design features,
construction, containment facilities, equipment, practices, and operational procedures
required for working with agents from the various risk groups. They are designated in
ascending order, by degree of protection provided to the personnel, the environment,
and the community (BMBL, 5th edition).
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 of microorganisms being handled in this level are Bacillus subtilis, Naegleria
gruberi, infectious canine hepatitis virus, and exempt organisms under the NIH
Guidelines. This level is the most appropriate among undergraduate and secondary
educational training and teaching laboratories that require basic laboratory safety
practices, safety equipment, and facility design that requires basic level of containment.
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 of
microorganisms that could be handled under this level are Hepatitis B virus, HIV,
salmonellae, and Toxoplasma species. BSL-2 is appropriate when work is done with
human blood, body fluids, tissues, or primary human cell lines where there is uncertain
presence of infectious agents. Hand washing sinks and waste decontamination facilities
must be available and access to the laboratory must be restricted when work is being
conducted. All procedures where infectious aerosols or splashes may be created are
conducted in biosafety cabinets or other physical containment equipment.
3.       Biosafety Level 3 (BSL-3) puts emphasis on primary and secondary barriers in the
protection of the personnel, the community, and the environment from infectious
aerosol exposure. Work with indigenous or exotic agents with a potential for respiratory
transmission, and that may cause serious and potentially lethal infection are being
conducted here. Examples of microorganisms handled here are Mycobacterium
tuberculosis, St. Louis encephalitis virus, and Coxiella. All laboratory activities are
required to be performed in a biosafety cabinet or other containment equipment like a
gas-tight aerosol generation chamber. Secondary barriers for this level are highly
required including controlled access to the laboratory and vent requirements to
minimize the release of infectious aerosols from the laboratory while special engineering
and design features are being considered. Personnel must be supervised by scientists
competent in handling infectious agents and associated procedures in a BSL-3
laboratory.
4.       Biosafety Level 4 (BSL-4) is required for work with dangerous and exotic agent
that pose high individual risks of life-threatening diseases that may be transmit via the
aerosol 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 riel of exposure and
infection to laboratory personnel, community, and environment The laboratory worker's
complete isolation from aerosolized infectious material is accomplished primarily by
working in a Class III biosafety cabinet or in a full. Body, air-supplied positive-pressure
personnel suit. A BSL-4 laboratory is generally a separate building or completely isolated
zone with specialized ventilation requirements and waste management systems.
Laboratory staff must have specific and thorough training in handling extremely
hazardous infectious agents. The laboratory is controlled by the laboratory supervisor in
accordance with institutional policies.
 

 
 Unit 8: BIORISK MANAGEMENT
In working with infectious agents and toxins in laboratories, one must consider the
practices and procedures on biocontainment to ensure biosafety and biosecurity. Proper
management is necessary to carry out total safety of laboratory workers and patients.
 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).
 According to the CEN Workshop Agreement (CWA) 15793:2011, 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.
 
Like a three-legged stool, a biorisk management system fails if one of the components,
or legs, is overlooked or is not addressed. In contrast to other risk management models,
which typically focus heavily on mitigation measures, AMP focuses on all components
with equal attention.
 
 Learning Outcomes
  At the end of this unit, students will be able to:
  1.       Explain the importance of  biorisk management.
2.       Discuss the AMP model.
3.       Explain the procedures on Risk Assessment.
4.       Enumerate the different mitigation procedures.
5.       Discuss the procedures on performance evaluation.
 

Presentation of Contents

Biorisk Management and the AMP Models

 
Key Components of Biorisk Management
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 unpleasant (such as an injury or loss) will happen. In
order for a risk to occur, there must be situation for the hazard to cause harm (ISO/IEC
Guide 51:1999). For example, a sharp needle is a hazard, but if no one is using it, the
needle will not pose any risks. More specifically, risk is the likelihood that an adverse
event involving a specific hazard or threat will occur followed by the consequences of
that occurrence. In performing risk assessment, a structured and repeatable process is
followed. It consists of the following steps:
1.      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 also be
defined.
2.       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.
3.      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.
4.       Determine if risks are acceptable or not - this process of evaluating the
biorisk arising from a biohazard takes into account the adequacy of any existing
controls, and deciding whether or not the biorisk is acceptable.
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 place to read or eliminate the risks associated with biological agents and toxins
(Salerno, 2015). There a five major areas of control or measures that can be employed in
mitigating the risks.
            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 entry order to reduce the risks. For
example, a laboratory conducting research with the pathogen Bacillus anthracis,
responsible for causing the acute fatal disease anthrax, could potentially substitute a
less dangerous experimental surrogate, such as the Bacillus thuringiensis, an organism
most commonly used in biological pesticides worldwide. The third control measure,
setting of 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. Examples are installation of biosafety cabinets,
safety equipment (centrifuge with cover, autoclave, and machines with indicators), and
facility design enabling proper airflow, and ventilation system to ensure directional
airflow, and air treatment systems to decontaminate or remove agents from exhaust air,
controlled access zones, airlocks as laboratory entrances, or separate buildings or
modules to isolate the laboratory. The fourth measure, the setting of administrative
controls, refers to the policies, standards, and guidelines used to control risks.
Proficiency and competency training for laboratory staff is considered an administrative
control. The displaying of biohazard or warning signages, markings, and labels,
controlling visitor and worker access, and documenting written standard operating
procedures are some examples. Practices and procedures of administrative controls
comprise minimizing splashes, sprays, and aerosols to avoid laboratory-acquired
infections or following standard operating procedures (SOPs). The last mitigation
control measure is the use of personal protective equipment (PPE). These are devices
worn by workers to protect them against chemicals, toxins, and pathogenic hazards in
the laboratory.
            Gloves and respirators are all examples of PPE. PPE is considered measure
because it only protects the person who is wearing it, and only when it is used correctly.
            As emphasized by Salerno (2015), not one of the mitigation controls completely
effective at controlling or reducing all risks. The effectivity of mitigating of mitigating
risks relies on the combination of all the different measures and the proper utilization of
each: be ensured that following the measures would not be overdone because undoing
particular measures are definitely costly. The concept of a hierarchy of controls describes
the order of effectiveness (from most effective to least effective) of mitigation measures
and implies that this order should be taken into account when selecting and
implementing controls to reduce risks.
 
Performance Evaluation
            The last pillar of the biorisk management model is performance evaluation that
involves a systematic process intended to achieve organizational objectives and goals.
The model ensures that the implemented mitigation measures are indeed reducing or
eliminating miles to also help to highlight biorisk strategies that are not working
effectively and measures the ineffective or unnecessary. These can be eliminated or
replaced. Performance management is simply a reevaluation of the overall mitigation
strategy. The diagram below shows the procedures in conducting performance
evaluation.
            The result of a robust risk assessment must be properly recorded, documented,
and communicated to all stakeholders of the organization. Only through this final
process that findings could be decided upon, given appropriate action, to be able to
provide and establish a clear manifestation of implementing the fundamental concept of
biosafety and biosecurity in the laboratory.
 Unit 9: HEALTH CARE WASTE
The disposal of wastes generated by health care facilities has become a growing
concern in the country and around the world. In 2015, a joint WHO/UNICEF assessment
found that just over half (58%) of sampled facilities from 24 countries had adequate
systems in place for the safe disposal of health care wastes. This issue is given special
attention as the wastes generated by the health care industry may be hazardous to
nature and are detrimental to a person's health and to the environment. As such, all
health care facilities are tasked to ensure that there are no adverse health effects and
environmental consequences resulting from their generation, segregation, collection,
storage, transport, treatment, and disposal of health care wastes.

Learning Outcomes
At the end of this unit, students will be able to:
1.    Discuss the importance of proper waste management in healthcare facilities.
2.    Discuss the proper identification, segregation, collection, storage, transport,
treatment and disposal of healthcare wastes.
 
Presentation of Contents
Defining Health Care Wastes
Health care wastes refer to all solid or liquid wastes generated by any of the following
activities:
1. diagnosis, treatment, and immunization of humans; 
2. research pertaining to diagnosis, treatment, and immunization of humans; 
3. research using laboratory animals geared towards improvement of human health; 
4. production and testing of biological products; and 
5. other activities performed by a health care facility that generates wastes.
 
According to WHO, between 75 and 90 percent of wastes generated by health care
activities on average are non-hazardous. The remaining 10 to 25 percent is considered
hazardous and may be infectious, toxic, or radioactive. High-income countries typically
generating larger volumes of health care wastes produce 0.5 kg of hazardous waste per
hospital bed per day while low-income countries generate 0.2 kg on average. However,
proper segregation of hazardous and non-hazardous wastes in low-income countries
tends to be less implemented, thus making the real quantity of hazardous wastes much
higher. In the Philippines, 30.37 percent of wastes from health care facilities are
hazardous while the remaining 69.63 percent are general wastes. Philippine hospitals
generate an average of 0.34 kg of infectious sharps and pathological wastes and 0.39 kg
of general wastes per bed per day.
All health care facilities, institutions, business establishments, and other spaces where
health care services are offered with activities or work processes that generate health
care wastes are called health care waste generators. These include
1. hospitals and medical centers 
2. infirmaries 
3. birthing homes 
4. clinics and other health-related facilities
a. Medical
b. ambulatory 
c. dialysis
d. health care centers and dispensaries
e. surgical 
f. alternative medicine
g. dental 
h . veterinary
5. laboratories and research centers
a. medical and biomedical laboratories 
b. medical research centers
 c. blood banks and blood collection services
d. dental prosthetic laboratories 
e. nuclear medicine laboratories 
f. biotechnology laboratories 
g. animal research and testing 
h. drug testing laboratories
i. HIV testing laboratories 
6. drug manufacturers 
7. institutions
a. drug rehabilitation centers
b. training centers for embalmers. 
c. medical technology internship training centers
d. schools of Radiologic Technology
e. medical schools
f. nursing homes
g. dental schools
 
Categories of Health Care Wastes
Health care wastes generated by health care facilities are categorized into seven:
infectious waste, pathological and anatomical waste, sharps, chemical waste,
pharmaceutical waste, radioactive waste, and non-hazardous or general waste.
1. Infectious Waste refers to all wastes suspected to contain pathogens or toxins in
sufficient concentration that may cause disease to a susceptible host. It includes
discarded materials or equipment used for diagnosis, treatment, and management of
patients with infectious diseases. Examples include discarded microbial cultures, solid
wastes with infections such as dressings, sputum cups, urine containers, and blood bags,
liquid wastes with infections such as blood, urine, vomitus, and other body secretions,
and food wastes (liquid or solid) coming from patients with highly infectious diseases. 
2. 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. Examples include internal organs and tissues used for histopathological
examinations. Anatomical waste is a subgroup of pathological waste that refers to
recognizable body parts usually from amputation procedures. 
3. Sharps refer to waste items that can cause cuts, pricks, or puncture wounds. They are
considered the most dangerous health care waste because of their potential to cause
both injury and infection. Examples include used syringes in phlebotomy, blood lancets,
surgical knives, and broken glasswares. 
4. Chemical Waste refers to discarded chemicals (solid, liquid, or gaseous) generated
during disinfection and sterilization procedures. It also includes wastes with high
content of heavy metals and their derivatives. Common examples of this type of waste
are laboratory reagents, X-ray film developing solutions, disinfectants and soaking
solutions, used batteries, concentrated ammonia solutions, concentrated hydrogen
peroxide, chlorine, and mercury from broken thermometers and sphygmomanometers.
Chemicals are considered hazardous when they are:

 toxic (with health and environment 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)
5. Pharmaceutical Waste refers to expired, spilt, and contaminated pharmaceutical
products, drugs, and vaccines including discarded items used in handling
pharmaceuticals. It includes antineoplastic, cytotoxic, and genotoxic wastes such as
drugs used in oncology or radiotherapy, and biological fluids from patients treated with
the said drugs. Examples include empty drug vials, medicine bottles, and containers of
cytotoxic drugs including materials used for their preparation and administration such
as syringes, needles, and vials.
6. Radioactive Waste refers to wastes exposed to radionuclides including radioactive
diagnostic materials or radiotherapeutic materials. Residues from shipment of
radioactive materials and unwanted solutions of radionuclides intended for diagnostic
or therapeutic use are examples of radioactive wastes as well as liquids, gases, and
solids contaminated with radionuclides whose ionizing radiations have genotoxic
effects. In the hospital, usual examples of radioactive wastes include cobalt (Co 90),
technetium (99 Tc), iodine (131 I) and iridium (192 Ir), irradiated blood products and
contaminated waste, patient's excretion, and all materials used by patients exposed to
radionuclides within 4-8 hours. 
7. Non-hazardous or General Waste refers to wastes that have not been in contact
with communicable or infectious agents, hazardous chemicals, or radioactive
substances, and do not pose a hazard. Examples include plastic bottles, used paper
products, office wastes, scrap wood, and food waste of non-infectious patients. This
type of waste can be further classified as a. 
A. Recyclable wastes in health care facilities such as
·         paper products such as used office paper, computer printouts, and corrugated
cardboard boxes 
·         aluminum from beverage cans and other aluminum containers 
·         pressurized gas containers such as oxygen tanks
·         plastic products including polyethylene terephthalate (PET) plastic water bottles,
plastic milk containers, and polypropylene plastic bottles for saline solutions and
irrigation fluids 
·         glass such as used vials for sterile solutions 
·         wood such as scrap wood and used wood shipping pallets

 durable goods such as used furniture and furnishings

 electronic devices such as used computer equipment and print cartridges
b. Biodegradable health care wastes such as left-over food from non-infectious patients
and garden wastes such as grass trimmings and tree cuttings 
c. Non-recyclable/non-biodegradable health care wastes that cannot be classified into
either of the first two categories
 
Impact of Health Care Wastes
Individuals exposed to health care wastes such as the medical staff (doctors, nurses,
medical technologists, etc.), in- and out-patients, visitors, caregivers, support staff, waste
haulers, garbage pickers, and the general public are potentially at risk of being injured
or infected. Other potential hazards may include drug-resistant microorganisms that can
spread from health facilities into the environment. Exposure of the general population
can be mainly through chronic exposure (for prolonged periods in minute quantities) or
acute exposure (for short periods in large quantities).
Adverse health outcomes associated with health care wastes and by-products also
include
  sharps-inflicted injuries 
 toxic exposure to pharmaceutical products, in particular, antibiotics and
cytotoxic drugs released into the surrounding environment, and to substances
such as mercury or dioxins, during the handling or incineration of health care
wastes 
 chemical burns from disinfection, sterilization, or waste treatment
activities 
 air pollution arising as a result of the release of particulate matter during
medical waste incineration 
 thermal injuries occurring in conjunction with open burning and the
operation of medical waste incinerators 
 radiation burns
 
Treatment and disposal of health care wastes may pose health risks indirectly through
the release of pathogens and toxic pollutants into the environment. Following are some
guidelines in the treatment and disposal of health care wastes

 The disposal of untreated health care wastes in landfills can lead to the
contamination of drinking, surface, and ground waters if those landfills are
not properly constructed. 
 The treatment of health care wastes with chemical disinfectants can result
in the release of chemical substances into the environment if those
substances are not handled, stored, and disposed in an environmentally-
sound manner.
 Incineration of waste is widely practiced, but inadequate incineration or
the incineration of unsuitable materials results in the release of pollutants into
the air and in the generation of ash residue. Incinerated materials containing
or treated with chlorine can generate dioxins and furans, which are human
carcinogens and have been associated with a range of adverse health effects.
Incineration of heavy metals or materials with high metal content in particular
lead, mercury, and cadmium) can lead to the spread of toxic metals in the
environment. 
 Only modern incinerators operating at 850°C to 1100°C and fitted with
special gas cleaning equipment are able to comply with the international
emission standards for dioxins and furans. It should be noted that disposal of
health care wastes by incineration is not allowed in the Philippines.
 Alternatives to incineration such as autoclaving, microwaving, and steam
treatment integrated with internal mixing, which minimize the formation and
release of The chemicals or hazardous emissions should be given
 consideration in settings where there are sufficient resources to operate and
maintain such systems and disposal of Be the treated waste.
 
The following are the benefits achieved through proper and strict compliance with
standards on the management of health care wastes:

 protection of patients, health workers, and the general population from

the adverse effects of health care wastes to human health;
 contribution to the collaborative efforts around the world to protect the
environment from pollution and contamination caused by health care wastes; 
 increased compliance of health care institutions to the laws, regulations,
and  guidelines on health care wastes; and 
 prevention of long-term liabilities and loss of reputation caused by
violations to the laws, regulations, and guidelines on health care wastes.
 
Health Care Waste Management System
Health care wastes generated by health care facilities generally follow a well-defined
flow from the point of generation down to their treatment and disposal. In the health
care waste management hierarchy, it is highly preferable to prevent the generation of
wastes and to reduce the quantity of generated wastes by using different methods of
reusing, recycling, and recovering wastes.
 
The most important step in the proper management of health care wastes is waste
minimization using an approach known as the Green Procurement Policy. This policy
involves two aspects-waste prevention and waste reduction. Through proper
procurement planning wastes are minimized even before their generation. Health care
facilities are encouraged to avail of services that are the least harmful to the
environment and to purchase less polluting products. Also, waste reduction from the
source is implemented by encouraging proper waste segregation to determine the
nature and volume of generated wastes to allow efficient waste management at the
least cost.
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. Safety and efficiency,
however, should be considered when reusing medical items and devices. For example,
laboratory glassware like glass culture tubes can be used repeatedly after
decontamination. Recycling refers to the processing of used materials into new
products. Computer printouts from the hospital, for example, can be sold and recycled
into new paper products. The recovery of waste, on the other hand, is 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 a term used to encompass three subsets of
waste recovery: recycling, composting, and energy recovery.
For wastes that cannot be safely reused, recycled, or recovered, the end of pipe
approach is implemented. This approach to health care waste management involves two
aspects: treatment and disposal. Waste treatment is the process of changing the
biological and chemical characteristics of waste to minimize its potential to cause harm.
Waste disposal, on the other hand, refers to discharging, depositing, placing, or
releasing any health care waste into air, land, or water. Not all types of wastes require
treatment. For example, food wastes from in-patients can be disposed of through
composting without the need for treatment. However, some materials need to be
treated first before disposal. Effluent wastewater from hospitals, for example, needs to
undergo sewage treatment prior to its release to the environment.
 
Segregation, Collection, Storage, and Transport of Health Care Wastes
Health care facilities are tasked to ensure that generated wastes are properly and safely
managed. To ensure this, health care wastes must be segregated, collected, stored, and
transported while considering risk and occupational safety and compliance with existing
laws, policies, and guidelines. Hazardous wastes must never be mixed with general
wastes and there must be a waste management officer responsible for the management
of the health care wastes of a facility.
The most important step in the proper management of health care wastes is waste
minimization using an approach known as the Green Procurement Policy. This policy
involves two aspects-waste prevention and waste reduction.
 
Guidelines for the Proper labeling, marking and color coding for waste segregation in
health care facilities
Type of waste Specifications
Infectious Waste BIN
Strong leak-proof bin with cover labelled
"Infectious" with biohazard symbol
 
LINER
Yellow plastic that can withstand autoclaving
with 0.009 mm thickness and labelled
"Infectious Waste" with a tag indicating source
and weight of waste and date of collection; may
or may not have biohazard symbol
 
Pathological and Anatomical Wastes BIN
  Strong leak-proof bin with cover labelled
"Pathological/Anatomical Waste" with
biohazard symbol
 LINER
Yellow plastic that can withstand autoclaving
with 0.009 mm thickness and labelled
"Pathological/Anatomical Waste" with a tag
indicating source and weight of waste and date
of collection. Biohazard symbol is optional
Sharps BIN 
  Puncture-proof container with wide mouth and
cover labelled "Sharps" with biohazard symbol 
LINER
Not applicable
Chemical Waste BIN
  Labelled "Chemical Waste"; For liquid
chemical waste, inside the bin is a disposal
bottle made of amber-colored glass with at least
4 liters capacity that is strong, chemical-
resistant, and leak-proof.
LINER
Yellow with black band plastic with 0.009 mm
thickness and labelled "Chemical Waste" with a
tag indicating source and weight of waste and
date of collection 
Pharmaceutical Waste BIN Strong leak-proof bin with cover labelled
  "Pharmaceutical Waste" for expired drugs and
drug containers and "Cytotoxic Waste" for
cytotoxic, genotoxic, and antineoplastic waste
LINER 
Yellow with black band plastic with 0.009 mm
thickness and labelled "Pharmaceutical Waste"
with a tag indicating source and weight of
waste and date of collection
 
Radioactive Waste BIN
                     Radiation proof repositories, leak-proof, and
lead-lined container labelled with name of
radionuclide and date of deposition with
radioactive symbol 
LINER 
Orange plastic with 0.009 mm thickness and
labelled "Radioactive" with a tag indicating
name of radionuclide and date of deposition.
General Waste BIN 
  Optional recycle symbol for recyclable non-
hazardous wastes; varying sizes depending on
the volume of waste.
LINER
 Black or colorless plastic for non-biodegradable
and green for biodegradable with a thickness of
0.009 mm with a tag indicating source, weight
of waste, and date of collection
 
Type of Waste
In the implementation of a color-coding system for health care wastes, the following
practices should be observed:
1. Highly infectious waste must be disinfected at source. 
2. Anatomical waste including recognizable body parts, placenta waste, and organs
should be disposed through safe burial or cremation. 
3. Pathological waste must be refrigerated if not collected or treated within 24 hours. 
4. Sharps must be shredded or crushed before they are transported to the landfill. 
5. Chemical and pharmaceutical wastes shall be segregated and collected separately.
Wastes with high content of heavy metals, except mercury, should be collected
separately and sent to the waste treatment facility. Waste containing mercury must be
collected separately. Hazardous chemical waste shall never be mixed or disposed down
the drain but shall be stored in strong chemical resistant leak-proof containers or amber
disposal bottles. Expired and discolored pharmaceuticals should be returned to the
pharmacy for temporary storage to be returned to the manufacturer/ supplier.
Pharmaceuticals shall be kept in their original packaging for proper identification and
prevention of possible reaction with other chemicals. 
6. Radioactive waste has to be decayed to background radiation levels. If it has reached
the background radiation level and is not mixed with infectious or chemical waste, the
radioactive waste is considered as regular non-infectious waste. 
7. All waste bins must be properly covered to prevent cross contamination. 
8. Aerosol containers can be collected with the general waste.
 
Aside from the information placed on the tag, yellow plastic liners should also be
labelled with symbols appropriate for the types of waste they contain. The following are
the symbols used by the DENR Environmental Management Bureau together with other
universally accepted hazard symbols.
Health care facilities should have storage areas for general wastes, recyclable materials,
hazardous wastes, and phased-out mercury devices. Cytotoxic wastes must be stored
separately from other wastes in a designated secured location while radioactive wastes
must be stored in containers that can prevent dispersion of radiation during the period
that their radionuclide contents are being allowed to decay.
Proper collection and transport of health care wastes are important components in
health care waste management. Their implementation requires commitment and
cooperation among all the workers in the health care facility. There must be a regular
on-site collection of wastes and these must be transported using designated trolleys to
the facility's waste treatment area or waste storage facility. During on-site collection and
transport, the personnel hauling the wastes must be properly trained and should wear
appropriate personal protective equipment (PPE) to minimize the risk of infection and
injury. For off-site transport of health care wastes, only accredited DENR transporters
and official waste collectors are allowed to transport wastes from the health care facility
to a Treatment/Storage/Disposal (TSD) facility or to the final disposal site.
 
Treatment and Disposal of Health Care Wastes
Proper waste treatment is necessary to ensure that health care wastes do not pose harm
to the people and the environment. The manner of waste treatment usually varies and
largely depends on the type of waste that needs to be inactivated and its potential
impact. Health care wastes can be decontaminated either by sterilization or disinfection.
Sterilization kills all microorganisms while disinfection reduces the level of
microorganisms present in the material.
Listed below are the acceptable technologies and methods used in the treatment of
health care wastes.
1. Pyrolysis is the thermal decomposition of health care wastes in the absence of
supplied molecular oxygen in the destruction chamber where the said waste is
converted into gaseous, liquid, or solid form. This can handle the full range of health
care wastes. Waste residues may be in the form of greasy aggregates or slugs,
recoverable metals, or carbon black. These residues are disposed in a landfill. 
2. Autoclave is the use of steam sterilization to render waste harmless and is an efficient
wet thermal disinfection process. This method of using pressure and heat is widely used
and the usual setting is at 121 °C with a pressure of 15 psi for 15 to 30 minutes.
Indicators such as color-changing tapes or biological test ampules containing bacterial
spores can be used to check the validity of the sterilization. 
3. Microwave is a technology that typically incorporates some type of size reduction
device. Shredding of wastes is done before disinfection. In this process, waste is exposed
to microwaves that raise the temperature to 100 °C (237.6 °F) for 30 minutes.
Microorganisms are destroyed by moist heat which irreversibly coagulates and
denatures enzymes and structural proteins. 
4. In chemical disinfection, chemicals like sodium hypochlorite, hydrogen peroxide,
peroxyacetic acid, and heated alkali are added to health care wastes to or inactivate
present pathogens. It is recommended that sodium hypochlorite beach) with a
concentration of 5 percent be used for chemical disinfection. This method, however,
generates chemical wastes from the used chemical disinfectants.
5. Biological process uses an enzyme mixture to decontaminate health care wastes. The
resulting by-product is put through an extruder to remove water for wastewater
disposal. The technology is suited for large applications and is also being developed for
possible use in the agricultural sector. 
6. Encapsulation involves the filling of containers with waste, adding and immobilizing
material, and sealing the containers. The process uses either cubic boxes made of high-
density polyethylene or metallic drums, that are three-quarters filled with sharps, or
chemicals or pharmaceutical residues. The containers or boxes are then filled up with a
medium such as plastic foam, bituminous sand, and cement mortar. After the medium
has dried, the containers are sealed and disposed in a landfill.
7. Inertization is especially suitable for pharmaceutical waste that involves the mixing of
waste with cement and other substances before disposal. For the inertization of
pharmaceutical waste, the packaging shall be removed, the pharmaceuticals ground and
a mixture of water, lime, and cement will be added. The homogenous mass produced
can be transported to a suitable storage site. Alternatively, the homogeneous mixture
can be transported in liquid state to a landfill and poured into municipal waste. The
process is relatively inexpensive and can be performed using relatively unsophisticated
equipment.
After treatment, health care wastes are usually disposed in landfills. A landfill is an
engineered site designed to keep waste isolated from the environment. This site must
secure proper permits from DENR before it can accept wastes. Health care wastes that
are properly treated can be mixed with general wastes provided that it is certified by the
DOH that the organisms in the waste products are inert and cannot regenerate. For
health care facilities in far-flung areas with no access to landfills, disposal is usually
through safe burial. As a disposal method, safe burial is only applicable to treated
infectious wastes, sharps, pathological and anatomical wastes, small quantities of
encapsulated/inertisized solid chemical and pharmaceutical wastes and only allowed in
health care facilities located in remote areas. Used sharps and syringes can also be
disposed using septic or concrete vaults if the health care facility has no access to a TSD
facility.
 
 Unit 10: PROFESSIONAL ORGANIZATIONS
Professional organizations are assemblages of professionals within a particular
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, and to represent the
interests of the industry in various groups such as local and national government units,
legislative bodies, and international societies. These organizations also provide
opportunities for professional growth and continuing education by offering workshops,
trainings and seminars, and by publishing research journals. Interested individuals must
pay membership fees and monthly or yearly dues to avail or access the benefits and
services that professional organizations offer to their members.
 
Learning Outcomes
 
At the end of this unit, students will be able to:
 

1. Identify the professional organizations for Medical Technologists,

2. Discuss the benefits of joining a professional organization.
3. Recognize the history and profile of the accredited professional
organization for Medical Technologists and the organization of schools of
Medical Technology.
Presentation of Contents
 
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).
There are several professional organizations that cater to Medical Technology/Medical
Laboratory Science professionals in the Philippines and abroad. Particularly, 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. On the other hand, 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. Its
membership is also open to deans, teachers, and clinical instructors in CHED-accredited
educational institutions offering Bachelor of Science in Medical Technology/Medical
Laboratory Science.
 
Benefits of Membership in Professional Organizations
According to Ryan Tracey (Top 6 Benefits of Membership Organizations: Are They Still
Relevant to eLearning), the benefits of membership in professional organizations are
professionalism, education, perks, networking, profile, and recognition.
 
Professionalism
Professionals must adhere to the set of rules or code of ethics prescribed by the
professional society. Although this is the least in terms of value among the benefits, this
is an advantage for employers since adherence to prescribed rules shapes the conduct
of a professional.
 
Education
Professional organizations organize continuing professional development (CPD)
activities for their members through conventions, seminars, fora, workshops, and other
activities of similar nature. Also, most professional societies publish research journals
which could serve as avenues for improving the body of knowledge in a certain field.
 
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 abroad.
 
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. A professional
organization can be multipurpose and could encompass all functions.
 
1. 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. Membership in this type of professional organization is
limited and is usually institutional.
 
·         PAASCU
Philippine Accrediting Association of Schools, Colleges, and Universities 
 
·         PACUCOA
Philippine Association of Colleges and Universities Commission on Accreditation
 
2. Credentialing/Certifying Organizations
Credentialing or certifying organizations provide certification examinations for
professionals. Certified professionals are required to renew their licenses within a
specified duration. In the Philippines, credentialing professional organizations are not
common due to the presence of a government professional regulatory body, the
Professional Regulation Commission (PRC).
·         AMT
American Medical Technologists 
·         ASCP
American Society of Clinical Pathology 
·         ISCLT
International Society for Clinical Laboratory Technology 
·         NCA
National Certifying Agency for Medical Laboratory Personnel
 
3. Professional Societies
Professional societies are organizations that contribute to the continued development of
a specific group of professionals. Membership in a national society follows membership
in its local affiliate/chapter.
 
EXAMPLES OF LOCAL PROFESSIONAL SOCIETIES FOR MEDICAL TECHNOLOGIST
·         PAMET
Philippine Association of Medical Technologists, Inc. 
·         PASMETH
Philippine Association of Schools of Medical Technology
and Public Health, Inc. 
·         BRAP
BioRisk Association of the Philippines
·         PBCC
Philippine Blood Coordinating Council 
·         PCQACL
Philippine Council for Quality Assurance in Clinical Laboratories
·         PSM
Philippine Society of Microbiologists 
·         PhBBA
Philippine Biosafety and Biosecurity Association
 
EXAMPLES OF INTERNATIONAL PROFESSIONAL SOCIETIES FOR MEDICAL
TECHNOLOGIST
·         ASCP 
American Society for Clinical Pathology 
·         AMT
American Medical Technologists 
·         AACLS
ASEAN Association for Clinical Laboratory Sciences 
·         AAMLS
Asia Association of Medical Laboratory Scientists 
·         AAMLT
ASEAN Association of Medical Laboratory Technologists 
·         ASCLS
American Society for Clinical Laboratory Science
·         IAMLT
International Association of Medical Laboratory Technologists 
·         IFBLS
International Federation of Biomedical Laboratory Science 
·         ISCLT
International Society for Clinical Laboratory Technologists
 
Professional Journals
Professional journals are publications containing scholarly studies on specific
professional Gelds. Sponsored by professional organizations, these journals publish
articles and reviews of books and past articles and serve as a forum for new articles.
Compared to other types of publications, professional journals are normally prepared by
professionals in the field and are peer-reviewed by experts.
It is significant for professionals, especially those involved in education and research, to
have their work published in professional journals. Journals help disseminate such work
to other practitioners in the field. Publishing research studies also contribute to the
credibility of an individual in a field of study. 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 
Medical Laboratory Observer
Clinical Laboratory Science
Advances for Medical Laboratory Professionals 
American Journal for Clinical Pathology
LabMedicine
 
PAMET
The Philippine Association of Medical Technologists, Inc. (PAMET) is the national
professional organization of Registered Medical Technologists in the Philippines. It is a
nonstock, non-profit organization.
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.
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. 
 
• Professionalism
Professionalism refers to the positive traits and values, moral responsibility, social
responsiveness, and behavioral outlook which makes one highly respectable and
credible. 
•Commitment
Commitment is the unconditional, unwavering, and selfless dedication that one builds-in
into the practice of the profession characterized by initiative, creativity, and
resourcefulness to bring about quality health care and service to the public. 
• 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
(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.
PASMETH
The Philippine Association of Schools of Medical Technology and Public Health
(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.
 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. 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.

 Unit 11: CONTINUING PROFESSIONAL DEVELOPMENT

Most people associate learning with formal education. Aspiring professionals view the
attainment of quality education as a very important goal. However, the end of
compulsory education should not be viewed as freedom from educational obligation.
Learning happens through the course of a lifetime. It does not stop once graduation
togas are donned and diplomas are conferred.
 
Professionals should be lifelong learners. They are expected to have skills that are at par
with the requirements of companies to ensure the quality of services they will render.
Thus, a country's pool of professionals with up-to-date knowledge and skills translates
to public good. 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.
 
Aside from public accountability, the importance of lifelong learning is magnified by the
dynamic flow of information in present time. We live in the Information Age where
computers, robotics, Internet, and other ICT tools are the primary drivers of economic
growth. The age of digital revolution requires professionals to be adept in manipulating
these ICT tools for the efficient delivery of services to the public.
 
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.
 
In the regional context, lifelong learning is also encouraged. 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.
 
Learning Outcomes
 
At the end of this unit, students will be able to:
 
1.    Discuss the importance of lifelong learning among laboratory professionals.
2.    Discuss the legal basis for the implementation of CPD in the Philippines.
3.    Discuss the process of application for and acquisition of CPD units for registered
professionals.
4.    Identify factors that affect the implementation of the CPD law in the Philippine
context.
 
Presentation of Contents
 
Continuing Professional Development and its Legal Basis
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. As such,
CPD is the longest phase of professional education and is essential to the provision of
evidence-based health care in the contemporary health care setting. It provides a
structured framework to ensure improvement, progression, and career growth that
benefits both professionals and their respective organizations. Undertaking CPD
facilitates continued competence and personal and professional development, which in
turn translate to increased career worth that facilitates the advancement of the
profession.

CPD is embraced by developing countries as an effective way of maintaining and

improving the competencies of health professionals, thus, making it mandatory. This is
due to the requirement for health practitioners to demonstrate and maintain
competence in light of the ever-changing scope of practice and technological advances
in the field of medicine and allied health. In fact, participation of medical laboratory
scientists in CPD is a pre-requisite for salary adjustment and career advancement in
developed countries. The terms CPD (Continuing Professional Development) and CPE
(Continuing Professional Education) are often used interchangeably. However, 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.
On July 25, 1995, former President Fidel V. Ramos issued Executive Order No. 266
entitled "Institutionalization of the Continuing Professional Education (CPE) Programs of
the Various Professional Regulatory Boards (PRB) under the Supervision of the
Professional Regulation Commission (PRC).” Anticipating the stiff competition in the
global professional labor market as a result of the General Agreement on Trade in
Services (GATS) treaty by the World Trade Organization (WTO), the Philippine
government has required all Filipino professionals to undergo continuing education
programs. The order was implemented through PRC Resolution No. 381, Series of 1995
titled "Standardized Guidelines and Procedures for the Implementation of the
Continuing Professional Education (CPE) Programs for all Professions" which took effect
on November 13, 1995. Operations of CPE Councils were further strengthened by
Administrative Order No. 260 Series of 1996. E.O. No. 266 required the completion of 60
CPE units as a condition for the renewal of licenses of professionals in the country. The
said provision, however, was repealed by the passage of the PRC Modernization Act of
2000 (R.A. 8981), on December 05, 2000. In 2004, PRC issued Resolution No. 179
mandating the implementation of a voluntary CPE program for professionals. This was
repealed by PRC Resolution 2008-466 which emphasized the moral obligation of
professionals to obtain CPE units but in turn was repealed by PRC Resolution 2013-774
which revised the CPE/CPD Guidelines to CPD Guidelines. What was missing in earlier
orders, resolutions, and issuances, however, was a law that will empower the
implementation of CPD for professionals.
On July 21, 2016, Republic Act 10912 was passed into law and took effect on August 16,
2016. The said law mandated the strengthening of CPD programs for all regulated
professions and the creation of CPD Councils for each profession. It aims to
continuously improve the competence of professionals in accordance with international
standards of practice towards the uplifting of the general welfare, economic growth, and
development of the nation. The implementation of R.A. 10912 started on March 15,
2017 upon the effectivity of the PRC Resolution No. 1032, also known as the
Implementing Rules and Regulations of R.A. 10912.
R.A. 10912 defines lifelong learning as "learning activities undertaken throughout life for
the development of competencies and qualifications of the professional," while 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, self-directed 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 (MRA); 
2. ensure international alignment of competencies and qualifications of professionals
through career progression mechanisms leading to specialization/sub-specialization; 
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
needs; and 
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:
1. 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; 
2. provide support to lifelong learning in the enhancement of competencies of Filipino
professionals towards delivery of quality and ethical services both locally and globally;
and 
3. 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 (1) a member from the
Professional Regulatory Board (PRB) as chair, (2) the president or officer of an
Accredited Professional Organization (APO) as first member, and (3) 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) while
the second member is the president of the Philippine Association of Schools of Medical
Technology and Public Health, Inc. (PASMETH). The CPD Council is generally tasked to
oversee the implementation of the CPD program of the profession including the
evaluation and monitoring of CPD programs.
CPD providers need to apply their respective programs to the CPD Council at least 45
days prior to the conduct of the CPD activity. The CPD Council will then evaluate the
proposed activity and designate the number of units to be assigned to it. 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 Pharmacy - Department of Medical Technology
8. Far Eastern University - Nicanor Reyes Medical Foundation School of Medical
Technology
9. Centro Escolar University - College of Medical Technology 
10. Newborn Screening Society of the Philippines
11. Asian Hospital
12. Philippine Society of Echocardiography 
13. Angeles University Foundation 
14. University of the Immaculate Conception 
15. University of the Philippines Manila - College of Public Health 
16. Bicol Sanitarium 
17. Far Eastern University Manila - Department of Medical Technology 
18. Department of Health Regional Office III 
19. Department of Health - Health Facility Development Bureau 
20. Ilocos Training and Regional Medical Center - Department of Laboratories
21. St. Luke's Medical Center - Quezon City
 
CPD is a mandatory requirement in the renewal of the professional identification card
(PIC) of all registered and licensed professionals under the regulation of PRC. Even
professionals working abroad and senior citizens are covered by the said requirement.
Every professional is required to renew his or her PIC every three years. For the said
period, he or she must acquire a stipulated number of CPD units. For registered medical
technologists, the required number of CPD units for PIC renewal is 45 units or an
average of 15 units per year for three years. Any excess number of CPD units cannot be
carried over to the next three-year period except for the credit units from doctorate and
master's degrees or specialty trainings which are only credited once during the
compliance period.
During the initial implementation of the CPD requirement for PIC renewal, PRC
instituted a general transitory period as follows:
Required Number of CPD Units during the Transition Period
PIC Renewal Period Minimum CPD Units Required for the Profession
January to June 2017 0%
July to December 2017 30%
2018 60%
2019 onwards 100%