PLMS First Sem

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.
Four stages in the historical development of Medical Technology.
460 BC. Apothecaries Act of 1815 . Medical technology in the United States in 1871, establishment of clinical
laboratory and Medical technology course in the Philippines.
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 18 CENTURY TH
In the 18 century, medical practitioners in North Africa and Southern Europe received classical medical
th
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
Dr. William H. Welch- 1885.Ffirst professor of 1922-3035 clinical laboratories

Pathology at John Hopkins University
World War I- Was an important factor in the growth
of the clinical laboratory and produced a great
demand for technicians
Dr. William Osler -The first clinical laboratory was

opened in 1896 at the John Hopkins Hospital University of Minnesota-One of the first schools for
training workers was established.
A course bulletin was entitled “Courses in Medical

Technology for Clinical and Laboratory Technicians”
William Pepper Laboratory- clinical laboratory was (1922)
also opened at the University of Pennsylvania in 1896.
1921- The Denver Society of Clinical Pathologists was
Dr. James C. Todd- Wrote “A Manual of Clinical organized
Diagnosis”. Retitled “Clinical Diagnosis by Laboratory
Methods” in the 19 edition
th
1923-University of Minnesota was the first to offer
level program
1900: Census-100 technicians, all male were
employed in the United states World War II-The use of blood increased and the
“close system” of blood collection was widely adopted
1915-The state legislature of Pennsylvania enacted a
law requiring all hospitals and institutions to have an - Laboratory medicine certainly moved into an era of
adequate laboratory and to employ a full-time sophistication
laboratory technician
1920-Increased to 3,500
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 1902 – Karl Landsteiner- Distinguished blood groups
Microbiology. The improvement of the microscope through the development of the ABO blood group
system
1796 – Edward Jenner - Discovered Vaccination to
establish immunity to small pox.Immunology 1906 – August von Wassermann- Developed
immunologic tests for syphilis
1880 – Marie Francois Xavier Bichat-Identified organs
by the types of tissues. Histology 1906 – Howard Ricketts- Discovered microorganisms
whose range lies between bacteria and virus called
1835 – Agostino Bassi- Produced disease in worms by rickettsiae
injection of organic material. Bacteriology
1929 – Hans Fischer- Worked out the structure of
1857 – Louis Pasteur- Successfully produced immunity hemoglobin
to rabies
1954 – Jonas Salk - developed poliomyelitis vaccine
1866 – Gregor Mendel- Enunciated his law of
inherited characteristics from studies on plants 1973 – James Westgard- Introduced the Westgard
Rules for Quality Control in the Clinical Laboratory
1870 – Joseph Lister- Demonstrated that surgical
infections are caused by airborne organisms. 1980 – Baruch Samuel Blumberg- Introduced the
Hepatitis B vaccine
1877 – Robert Koch- Presented the first pictures of
bacilli (anthrax) and tubercle bacilli 1985 – Kary Mullis -Developed the Polymerase Chain
Reaction (PCR)
1886 – Ellie Metchnokoff - Described phagocytes in
blood and their role in fighting infection 1992 – Andre van Steirteghem - introduced the
intracytoplasmic sperm injection (IVF)
1886 – Ernst Von Bergmann- Introduced steam
sterilization in surgery 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.
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.
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 6. The Life and Works of Rizal
2. Readings in Philippine history 7. Science, Technology, and Society
3. The Contemporary World 8. Art Appreciation
4. Mathematics in the Modern World 9. 9. Ethics
5. Purposive Communication
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
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
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
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
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

Cover 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 • Characterization of colonies of bacteria growing

in culture media
• Collection of specimen
• Performing different biochemical tests for
• Preparation of bacterial smear identification of bacteria.
• Staining of smear • Biosafety and waste management
• Inoculation of specimen on culture media • 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.
school-based laboratory are:
• ABO and Rh typing • Compatibility testing
• Coombs test (direct and indirect Coombs) • Transfusion reaction work-up
• Blood donation process • 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
· Complete blood count (CBC) · Erythrocyte indices
· Hematocrit blood test · Reticulocyte count
· Platelet count · Instrumentation
· Preparation of blood smear and staining · Osmotic fragility test
· Red cell morphology · Quality assurance and quality control
· Erythrocyte sedimentation rate (ESR) · Biosafety and waste management
· Fragility test
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
· 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.
· 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.
· Instrumentation · Renal function tests (blood urea nitrogen (BUN),

blood uric acid (BUA),creatinine]
·Quality assurance and quality control
·Protein testing (total proteins, albumin, globulin)
·Glucose determination
·Biosafety and waste management
· Lipid testing (triglyceride, lipoproteins)
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.
· Bilirubin test ·Electrolyte testing
· Clinical enzymology (transferases, dehydrogenase, ·Hormone testing

hydrolases)
·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 21 century st
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.
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.
 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.
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.
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.
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.
Ex: 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.
Ex: -megaly – enlargement -emia –blood -uria - urine -ostomy - make opening
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.
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.
bacterium bacteria thrombus thrombi
nucleus nuclei bacillus bacilli
Root Words
cardio = heart pyo = pus
myo = muscle cranio = skull
arterio = arterys pyro = fever
cyto = cell nephro = kidney
arthro = joint osteo = bone
heap/hepato = liver
Prefixes
iso- = same mono- = one
micro- = small homo- = same, like
macro- = large nano- = billionth
intra- = inside/within cryo- = cold
pseudo- = false hypo- = decreased logamning
anaero- = without oxygen neo-= ne
Suffixes
-itis = inflammation of -meter = measure
-megaly = enlargement -penia = deficiency
-blast = young -ectomy = surgical removal
-cidal = killing of oma = tumor
-poiesis = formation -emia = blood condition to
pathy = disease -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 AIDS - Acquired BUN - Blood Urea Nitrogen

Immunodeficiency Syndrome
CHED - Commission on Higher 2PPBS - 2 hours Postprandial
Education AIDs - Autoimmune Blood Sugar
disorders/diseases
VDRL - Venereal Disease AFS - Acid Fast Stain
Research Laboratories AMI - Acute Myocardial
Infarction
PCQACL - Philippine Council for HIV - Human Immunodeficiency K - Potassium
Quality Assurance in the Clinical Virus
Laboratories Na - Sodium
IU - International Unit
FBS - Fasting Blood Sugar NPO- Nothing Per Orem
ICU - Intensive Care Unit
IV - Intravenous 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.
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.
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.
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 e. surgical
b. ambulatory f. alternative medicine
c. dialysis g. dental
d. health care centers and dispensaries h . veterinary
5. laboratories and research centers
a. medical and biomedical laboratories f. biotechnology laboratories
b. medical research centers g. animal research and testing
c. blood banks and blood collection services h. drug testing laboratories
d. dental prosthetic laboratories i. HIV testing laboratories
e. nuclear medicine laboratories
6. drug manufacturers
7. institutions
a. drug rehabilitation centers e. medical schools
b. training centers for embalmers. f. nursing homes
c. medical technology internship training centers g. dental schools
d. schools of Radiologic Technology
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 BIN -Strong leak-proof bin with cover labelled "Pathological/Anatomical Waste" with biohazard symbol
Wastes
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.
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 - 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.
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. 8. Far Eastern University - Nicanor Reyes Medical
(PAMET) Foundation School of Medical Technology
2. Philippine Association of Schools of Medical 9. Centro Escolar University - College of Medical

Technology and Public Health, Inc. (PASMETH) Technology
3. Research Institute for Tropical Medicine (RITM) 10. Newborn Screening Society of the Philippines
4. Philippine Blood Coordinating Council (PBCC) 11. Asian Hospital
5. Philippine Council for Quality Assurance in Clinical 12. Philippine Society of Echocardiography
Laboratories
13. Angeles University Foundation
6. National Reference Laboratory for HIV/AIDS and
other Sexually Transmitted Diseases, San 14. University of the Immaculate Conception
Lazaro Hospital (NRL-SLH/SACCL) 15. University of the Philippines Manila - College of
Public Health
7. University of Santo Tomas Faculty of Pharmacy -
Department of Medical Technology 16. Bicol Sanitarium
17. Far Eastern University Manila - Department of 20. Ilocos Training and Regional Medical Center -
Medical Technology Department of Laboratories
18. Department of Health Regional Office III 21. St. Luke's Medical Center - Quezon City
19. Department of Health - Health Facility

Development Bureau
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%

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HISTORY OF MEDICAL TECHNOLOGY PROFESSION

Four stages in the historical development of Medical Technology.

History of Medical Technology on a global context

MEDICAL TECHNOLOGY IN THE 18 CENTURY TH

Dr. William H. Welch- 1885.Ffirst professor of 1922-3035 clinical laboratories

Dr. William Osler -The first clinical laboratory was

A course bulletin was entitled “Courses in Medical

HISTORY OF MEDICAL TECHNOLOGY IN THE PHILIPPINES

Medical Technology in the Philippines post-World War II

HISTORICAL MILESTONES IN MEDICAL TECHNOLOGY

MEDICAL TECHNOLOGY AS AN APPLICATION OF SCIENCE AND TECHNOLOGY

Laboratory Information Systems

Genetic Engineering, Gene Therapy, and Gene Diagnosis

Laboratory Waste Management

Laboratory Diagnosis of Diseases of the 21st Century

Inventions and Innovations in the Field of Medical Laboratory

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

PRACTICE OF MEDICAL TECHNOLOGY PROFESSION

Roles and Responsibilities of Medical Technology Professionals

Perform Clinical Laboratory Testing

Perform Special Procedures

Ensure Accuracy and Precision of Results

Ensure Timely Delivery of Results

Collaborate with Other Health Care Professionals

Involvement in Health Promotion Programs

2. Implement pre-planned programs of health promotion campaigns.

DEFINING THE PRACTICE OF OTHER LABORATORY PERSONNEL

Medical Laboratory Technicians

As defined in R.A. 5527:

UNit 3: MEDICAL TECHNOLOGY/ CLINICAL LABORATORY SCIENCE EDUCATION

Medical Technology Curriculum

General Education Courses

1. Understanding the Self 6. The Life and Works of Rizal

2. Readings in Philippine history 7. Science, Technology, and Society

3. The Contemporary World 8. Art Appreciation

4. Mathematics in the Modern World 9. 9. Ethics

1. Principles of Medical Laboratory Science 1: Introduction to Medical Laboratory Science, Laboratory

2. Principles of Medical Laboratory Science 2: Clinical Laboratory Assistance and Phlebotomy

6. Histopathologic Techniques with Cytology

•Tissue processing techniques

•Cutting of processed tissues

•Mounting of stained tissue for microscopic examination

•Performing biosafety and waste management

• Preparation of culture media • Characterization of colonies of bacteria growing

• Staining of smear • Biosafety and waste management

• Inoculation of specimen on culture media • Quality assurance and quality control

• Antimicrobial susceptibility testing

9. Immunohematology and Blood Bank

• Coombs test (direct and indirect Coombs) • Transfusion reaction work-up

• Blood donation process • Preparation of RBC suspension

10. Mycology and Virology

12. Medical Technology Laws and Bioethics

· Complete blood count (CBC) · Erythrocyte indices

· Hematocrit blood test · Reticulocyte count

· Platelet count · Instrumentation

· Preparation of blood smear and staining · Osmotic fragility test

· Red cell morphology · Quality assurance and quality control

· Erythrocyte sedimentation rate (ESR) · Biosafety and waste management

· Identification of abnormal RBC and WBC

· Special staining techniques

· Routine urinalysis (macroscopic, microscopic, chemical examinations)

· Special chemical examination of urine