PLMS First Sem 2

You might also like

Download as docx, pdf, or txt
Download as docx, pdf, or txt
You are on page 1of 81

HISTORY OF MEDICAL TECHNOLOGY PROFESSION

Introduction 

The Medical Technology Profession has gone tremendous changes and improvements over
the years. These developments have been very essential and beneficial in the Health Care
delivery system.

There are four stages in the historical development of Medical Technology. The earliest
stage begun in 460 BC, followed by the formulation of the Apothecaries Act of 1815, the
modern onset of the Medical technology in the United States in 1871, and the
establishment of clinical laboratory and medical technology course in the Philippines.
Evidently, Medical Technology is still progressing along with new advancements and
discoveries in the field of Science and Technology. Now and in the future, trends in Medical
Technology practices will help meet the demand of the times by enabling the introduction
of more techniques in treating, diagnosing, preventing, and controlling infectious diseases
in a steadfast and comprehensive manner.

The two most important priorities of medical technology are future challenges in the roles
and contributions of medical laboratory technology, and the effort to address gaps and
shortcomings in the field of Medical Technology

Learning Outcomes

At the end of this unit, students will be able to:

1.      Discuss the history of medical technology on a global context.

2.      Discuss the history of medical technology in the United States.

3.      Discuss the history of medical technology in the Philippines.

4.      Identify important personalities that played a significant role in the progress of


medical technology profession.

5.      Discuss the historical milestones in Medical Technology

 Presentation of Contents

 History of Medical Technology on a global context

 The evolution of medical technology can be traced to the understanding of the concept of
diseases and infections during ancient times. In 460 BC, Greek physician Hippocrates,
regarded as the founder of scientific medicine, determined the correlation between
anatomical and chemical laboratory findings and the causes of diseases. He adopted the
triad of regimen in treating diseases and infection with the use of drugs, surgery, and
bloodletting.

            As early as 1550 BC, Vivian Herrick determined that intestinal parasitic infection was
caused by Ascaris lumbricoides and the Taenia species. This was published in a book by
Ebers Papyrus , which describes the treatment of hookworm disease and infection
transmissible in humans. In the same year, Anenzoa, an Arabian physician, also proved that
the etiological agent of skin diseases, such as scabies, is parasites.
            During the medieval period (1098-1438), urinalysis became commonplace and was a
practice that was followed with exaggerated zeal. During that period, some doctors of
dubious credentials in the Indian subcontinent recorded several observations on the urine
of some patients. They determined that the urine of certain patients that attracted ants had
a sweet taste. This information was criticized by some medical professionals and was even
mentioned in the book authored by Ruth Williams, entitled An Introduction to the
Profession of Medical Technology.

            In the 14th century, Anna Fagelson strongly confirmed the beginnings of medical
technology when she correlated the cause of death of Alexander Gillani, a laboratory worker
in the University of Bologna, to laboratory-acquired infection.

            The 17th century witnessed, with the invention of the first functional crude
microscope by Anton Van Leeuwenhoek, rapid advancements in discoveries. Van
Leeuwenhoek was the first scientist to observe and describe the appearance of red blood
cells, and to differentiate bacteria based on their shape.

MEDICAL TECHNOLOGY IN THE 18TH CENTURY

            In the 18th century, medical practitioners in North Africa and Southern Europe
received classical medical education. According to them, there are four basic humors and
the state of balance between these humors can be correlated with the healthy condition of
the human body, and the state of unbalance can be diagnosed by means of urine
examination. The four humors are blood, phlegm, black bile and yellow bile.

            Between 1821 and 1902, Rudolf Virchow was recognized as the father of microscopic
pathology. He was the first scientist/physician of the time who emphasized the study of the
manifestation of diseases and infections, which are visible at the cellular level by means of a
microscope.

            In the process of evaluating disease and infections, Dr. Calvin Ellis, a microscopist,
was the first to utilize the microscope in examining specimens at the Massachusetts General
Hospital. On the other hand, it was Dr. William Occam who used laboratory findings as
preliminary evidence in diagnosing and evaluating a patient's disease.

            The function of medical technology has become explicitly apparent when the
Apothecaries Act of 1815 intervened and paved the way for an uphaul of medical treatment
based on laboratory findings. This Act was initiated by Baron Karl Von Humbeldt, who
formally used laboratory findings in the treatment of diseases and infection. The
Apothecaries Act 1815 was formulated to better regulate the practice of apothecaries
throughout England and Wales. The Act introduced compulsory apprenticeship and formal
qualifications for apothecaries (in modern terms, general practitioners) under the license of
the Society of Apothecaries. It was the beginning of regulation of the medical profession in
the United Kingdom. The Act required instruction in anatomy, botany, chemistry, material
medical, and “physic," in addition to six months of practical working experience in a hospital.

HISTORY OF MEDICAL TECHNOLOGY IN THE UNITED STATES

Advances in scientific knowledge in the field of medicine were applicable to both medical
practice and medical education in Europe and America. In the United States, medical
education underwent much needed reforms.
´  Dr. William H. Welch

´  In1885, Dr. Welch became the first professor of Pathology at John Hopkins University

´  *The first clinical laboratory was opened in 1896 at the John Hopkins Hospital by Dr.
William Osler.

´  * A clinical laboratory was also opened at the University of Pennsylvania in 1896. (William
Pepper Laboratory)

´  Dr. James C. Todd

´  Wrote “A Manual of Clinical Diagnosis”

´  Retitled “Clinical Diagnosis by Laboratory Methods” in the 19 th edition

´  1900: Census

´  100 technicians, all male were employed in the United states

´  1915

´  The state legislature of Pennsylvania enacted a law requiring all hospitals and institutions
to have an adequate laboratory and to employ a full-time laboratory technician

´  1920

´  Increased to 3,500

´  1922

´  3035 hospitals had clinical laboratories

´  World War I

´  Was an important factor in the growth of the clinical laboratory and produced a great
demand for technicians

´  University of Minnesota

´  Where one of the first schools for training workers was established

´  A course bulletin was entitled “Courses in Medical Technology for Clinical and Laboratory
Technicians” (1922)

´  1921

´  The Denver Society of Clinical Pathologists was organized

´  1923

´  University of Minnesota was the first to offer level program

´  World War II
´  The use of blood increased and the “close system” of blood collection was widely adopted

´  Laboratory medicine certainly moved into an era of sophistication

HISTORY OF MEDICAL TECHNOLOGY IN THE PHILIPPINES

Medical Technology in the Philippines post-World War II

            At the end of World War II, the first clinical laboratory in the Philippines was built
and established on Quiricada Street, Sta. CruzManila (where the public health laboratory is
presently located) by the 26th Medical Laboratory of the 6th US Army.

            In February 1944, it provided one year of training to high school graduates to work
as laboratory technicians. In June 1945, the staff of the 6th US Army left the facility after
endorsing the newly established Clinical Laboratory to the National Department of Health.
However, its laboratory facilities were not fully utilized and later, it stopped being used
because the science was not popular during those days.

            Dr. Pio de Roda, a Filipino doctor who was a dislocated staff of the 26th Medical
Laboratory and a well-known bacteriologist, preserved the remains of the laboratory with
the help of  Dr. Mariano Icasiano, the first City Health Officer of Manila. On October 1, 1945,
the preserved laboratory was formally re-established by Dr. Pio de Roda with the help of Dr.
Prudencio Sta. Ana. They offered free training to most trainees who were high school
graduates and paramedical graduates. With no specific duration of training and no
certification, the training lasted from a week to a month. In 1954, Dr. Pio de Roda instructed
Dr. Sta. Ana to prepare a syllabus for training medical technicians. Together with Dr. Tirso
Briones, they conducted a six month training course with certification. However, their
project did not last long because the Manila Sanitarium Hospital and its sister company the
Philippine Union College offered a course in medical technology. In the same year, through
the efforts of an American medical practitioner and a Seventh Day Adventist missionary, Dr.
Willa Hilgert Hedrick, founder of medical technology education in the Philippines, Dr.
Reuben Manalaysay; president of the Philippine Union College, Rev. Warren; president of
the North Philippine Mission of the Seventh Day Adventist and director of the Bureau of
Education, established the first Medical Technology School in the Philippines.

            Dr. Hedrick, with the help of Mrs. Antoinette McKelvey, prepared the course
curriculum and established the first complete laboratory in microbiology, parasitology, and
histopathology at the Manila Sanitarium Hospital. In the same year, a five-year course
leading to a Bachelor of Science degree in medical technology was approved by the Bureau
of Education and was finally offered by the Manila Sanitarium Hospital and the Philippine
Union College. In 1956, Mr. Jesse Umali became the first student to graduate from the
Philippine Union College. He later went on to pursue his studies in medicine and graduated
from Far Eastern University.

            Other schools had started to offer the course; for instance, in 1957, the University of
Santo Tomas offered an elective course in pharmacy leading to a bachelor of science in
medical technology under the leadership of Dr. Antonio Gabriel and Dr. Gustavo Reyes. In
1960–61, the Bureau of Education officially approved the first three years as a three-year
academic course and the fourth year as an internship program. At the same time, Carmen
de Luna, President of the Centro Escolar University delegated Purification Sunico-Suaco to
work on offering the medical technology course, which was later granted a recognition
permit by the Bureau of Education and had its first graduates two years later.
            In 1961, through the combined efforts of Dr. Horacio Ylagan and Dr. Serafin J.
Juliano with the authority granted to them by Dr. Lauro H. Panganiban and Dr. Jesus B.
Nolasco, dean of the Institute of Medicine, the Far Eastern University started its School of
Medical Technology, which was formally approved by the Bureau of Education. Dr. Ylagan
became the technical director of the school and had its first graduates in 1963.

            Several colleges and universities throughout the country began offering the
bachelor's degree in medical technology. The postgraduate course is now offered at the
University of Santo Tomas and Philippine Women's University.

HISTORICAL MILESTONES IN MEDICAL TECHNOLOGY

MEDICAL TECHNOLOGY AS AN APPLICATION OF SCIENCE AND TECHNOLOGY

            Medical technology employs a wide variety of technologies ranging from a single-
lens microscope to dissecting and scanning electron microscopes. Highly technical
instruments such as the auto analyzer in clinical chemistry or the flow cytometer in
histopathology are typically used in tertiary and highly sophisticated laboratories.
Diagnostics is moving toward automation coupled with the use of computer graphics,
recorders, and even calculators. The use of these technologies in the scientific evaluation of
diseases and infection clearly shows that medical technology is synonymously adjunct and
within the ambit of the term “science and technology.

            Within the context of science and technology, the prime goal of medical technology
is to engender the cultural and democratic notions of scientific literacy. In addition, science
and technology helps students have a better understanding of scientific learning in order to
become better and responsible citizens. The practical value of science with regard to
humankind can be seen through the advancements in technology. Science and technology
have provided society with various benefits like improved health and standard of living. The
direction that technology takes depends less on science; its progress and development is
determined by the needs of humans and the values of society.

            Medical technology is one discipline that can help students acquire knowledge
beyond the traditional and formal learning about scientific theory, facts, and technical skills.
In addition, it also equip students with a better understanding of scientific learning and
makes them aware of the trends in technological developments, thereby providing a
meaningful impact in their social, political, economic, environmental, and cultural context of
life. Moreover, medical technology has transcended the evaluation of the health status and
condition of every individual member of a society. It is a scientific discipline that reinforces
the concepts and principles of science and technology to facilitate the understanding of life
and the onset of diseases. The concrete application of these concepts and principles can be
seen in the following:

Laboratory Information Systems

            With the evolution of electronic and technological devices, clinical laboratories are
also moving toward innovation and meeting the immediate demands of health laboratory
services. This has led to the development of the ultimate science and technology product-
the Laboratory Information System (LIS). Almost all clinical laboratories, especially those in
the tertiary category, use the LIS to release laboratory results.

Professional Practice
            In professional practice, there are always guiding policies that should be strictly
followed. A medical technologist should observe the code of ethics and the patient's rights.
The symbol of a microscope will remain synonymous with medical technology.

Genetic Engineering, Gene Therapy, and Gene Diagnosis

            Genetic engineering is the answer to the demands of the current generation. It
enables access to gene therapy and diagnosis. Medical technology uses genetic engineering
methods, especially in cases of detecting genetic disorders such as hemophilia.

Laboratory Waste Management

            Microorganisms are ubiquitous. Thus, the implementation of laboratory


management should continuously and closely monitor how laboratory wastes are managed,
handled, and disposed. These techniques are used to prevent the spread of communicable
diseases.

Laboratory Diagnosis of Diseases of the 21st Century

           In highly sophisticated and accredited clinical laboratories, automated and


conventional or manual methods are used. This type of setting ensures the accuracy of
laboratory results in diagnosis of diseases of the 21st century. Epidemiologically speaking,
these diseases may be endemic or epidemic depending on the climatic changes. For
example, the HINI influenza viral infection has become the focus of attention due to
significant infection rates, which signalled a need for accurate laboratory diagnosis. And just
recently the world is facing another challenge this is the SARS-Cov-2 virus (COVID-19)). It
has been considered a pandemic viral infection causing thousands of deaths worldwide in
just a matter of months. Thus the need for very reliable and accurate laboratory diagnosis
for early treatment of the disease.

Scientific Research

          Many new products and laboratory procedures have been systematically established
through the efforts and enthusiasm of medical technology professionals. Current research is
moving toward the molecular diagnosis of diseases and infections. The ultimate goal of
medical technology is its commitment to focus on more discoveries. This goal can be
attained through the efforts extended by science and technology.

Inventions and Innovations in the Field of Medical Laboratory

1660 – Anton Van Leeuwenhoek

                        - Father of Microbiology

                         - Known for his work on the improvement of the microscope

1796 – Edward Jenner

                        - Discovered Vaccination to establish immunity to small pox

                        - impact of contribution: Immunology

1880 – Marie Francois Xavier Bichat

                        - Identified organs by the types of tissues


                        - Imapct of contribution: Histology

1835 – Agostino Bassi

                        - Produced disease in worms by injection of organic material

                        - impact of contribution: beginning of bacteriology

1857 – Louis Pasteur

                        - Successfully produced immunity to rabies

1866 – Gregor Mendel

                        - Enunciated his law of inherited characteristics from studies on plants

1870 – Joseph Lister

                        - Demonstrated that surgical infections are caused by airborne


organisms.

1877 – Robert Koch

                        - Presented the first pictures of bacilli (anthrax) and tubercle bacilli

1886 – Ellie Metchnokoff

                        - Described phagocytes in blood and their role in fighting infection

1886 – Ernst Von Bergmann

                        - Introduced steam sterilization in surgery

1902 – Karl Landsteiner

                        - Distinguished blood groups through the development of the ABO


blood group system

1906 – August von Wassermann

                        - Developed immunologic tests for syphilis

1906 – Howard Ricketts

                        - Discovered microorganisms whose range lies between bacteria and


virus called rickettsiae

1929 – Hans Fischer

                        - Worked out the structure of hemoglobin

1954 – Jonas Salk

                        - developed poliomyelitis vaccine


1973 – James Westgard

                        - Introduced the Westgard Rules for Quality Control in the Clinical

                          Laboratory

1980 – Baruch Samuel Blumberg

                        - Introduced the Hepatitis B vaccine

1985 – Kary Mullis

                        - Developed the Polymerase Chain Reaction (PCR)

1992 – Andre van Steirteghem

                        - introduced the intracytoplasmic sperm injection (IVF)

1998 – James Thomson

                        - Derived the first human Stem Cell line

FUTURE TRENDS:

Latest technologies include robotic devices, keyhole surgery procedures and genetic
engineering created from knowledge about DNA molecules

 History of Medical Technology Profession Quiz

 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.

Learning Outcomes

 At the end of this unit, student can:

1.      Discuss the practice of medical technology as to nature of the profession in relation to


detection and diagnosis of diseases.

2.     Differentiate the medical technology practice from other laboratory personnel such as
laboratory technicians, pathologists and alike.
 

Presentation of Contents

PRACTICE OF MEDICAL TECHNOLOGY PROFESSION

Roles and Responsibilities of Medical Technology Professionals

            Medical Technology is indeed a rapidly advancing discipline and profession. The role
of medical technology professionals in the diagnosis and treatment of diseases is very
crucial in health care practice. In the Philippines, R.A. 5527 or the Medical Technology Act of
1969, defines the scope of work of the different medical technology professionals. There is
no doubt that the role of the medical technologist is to collaborate with other health care
practitioners to provide humane and dignified health service. The following are the tasks of
medical technology professionals in the practice of laboratory science.

Perform Clinical Laboratory Testing

            A medical technologist must be capable of performing the most basic to the most
advanced laboratory tests. A graduate of Bachelor of Science in Medical
Technology/Medical Laboratory Science is expected to show competency in performing
routine laboratory tests including urinalysis and stool examination. He or she should be
capable of performing hematologic, microbiologic, serologic, chemical, and other
procedures in the different areas of laboratory science. In turn, it is expected that the clinical
laboratory will be equipped with the resources necessary for performing such procedures or
any kind of laboratory testing.

Perform Special Procedures

            Medical technologists are also expected to perform special procedures in diagnosing
diseases. These may include the operation of advanced diagnostic equipment. Special
procedures can also include molecular and nuclear diagnostics.

Ensure Accuracy and Precision of Results

            In performing different procedures to diagnose diseases, a medical technologist


should always be conscious of the accuracy and precision of both the testing process and its
results. Accuracy and precision impacts the interpretation of results by the physician to
provide proper medication in the treatment of diseases.

Be Honest in Practice

            A practicing medical technologist, like any other professional, is expected to be


honest in the practice of his or her work. It is important that a medical technologist values
honesty, particularly in conveying or reporting the results of any laboratory procedure. He
or she should act according to the Medical Technology profession's Code of Ethics and his
or her pledged oath of practice. A medical technologist must be honest at all times in the
conduct of test procedures to come up with accurate and precise results.

Ensure Timely Delivery of Results

In collaborating with other health care practitioners, a medical technologist MUST be aware


of the urgency of delivering results on time especially in cases that require treatment. There
are times when physicians will request laboratory tests which require immediate action. One
should take notations on "STAT” or even observe the source of the requests (e.g., from the
emergency room [ER] or operating room [OR]). It is important for a medical technologist to
be alert to fully address the needs of the patient. Since laboratory procedures are time
bound, it is important that a medical technologist is able perform the duties required of him
or her, as soon as possible.

Demonstrate Professionalism

            A medical technologist must be able to perform his or her functions according to the
professional Code of Ethics for medical technology professionals. He or she should be aware
of the laws and regulations governing the practice of medical technology and should not
exploit its function beyond its boundaries. In the Philippines, the practice of medical
technology profession is governed by R.A. 5527 or the Philippine Medical Technology Act of
1969. Other governing regulations are supplemented by the Clinical Laboratory Act of 1966
(R.A. 4688) and the Blood Banking Acts of 1956 (R.A. 1517) and 1995 (R.A. 7719). National
organizations such as the Philippine Association of Medical Technologists, Inc. (PAMET) and
the Philippine Association of Schools of Medical Technology and Public Health, Inc.
(PASMETH) also have their own constitutions and by-laws in accordance with the governing
laws and code of ethics.

Uphold Confidentiality

            Ensuring confidentiality of patient's information is one of the core duties within the
medical practice (De Bord et al.). Confidentiality requires health care providers to keep a
patient's personal health information private unless the patient consents to release the
information. Patient records are expected to be kept in confidence by the medical
technologist. It is expected that these records containing very important information are
protected and made available only when necessary. A medical technologist must be aware
at all times of the value of confidentiality and the entirety of the ethical codes of their
profession.

Collaborate with Other Health Care Professionals

A medical technology professional is required to collaborate with other health care


practitioners in order to build a well-functioning team. Most often, projects fail because
people fail to cooperate with others. Collaboration is the act of working together in order to
achieve a desired outcome. Success in the health care setting is achieved not because of the
availability of highly sophisticated hospital or laboratory equipment, but because of
teamwork. A highly-trained physician will only be able to efficiently treat his or her patient if
laboratory testing, monitoring, drug prescription and dosage, and more are properly
rendered administered by other health care professionals. These protocols cannot be done
by the physician alone. Having one non-collaborative and incompetent member in the team
and can result in potentially dire repercussions.

Conduct Research

            Practicing medical technologists must also be engaged in research activities to


enhance  their skills. Research work, whether experimental or descriptive can contribute
significantly to the discovery of new knowledge in the field of medical technology and in
assessing and revisiting already known ones. It can greatly help in the further development
of the field and may be used as future reference for patient care.

Involvement in Health Promotion Programs


            Medical technologists should not be confined only to the four corners of their
clinical laboratories. Medical technology is a multi-disciplinary field which consistently
ventures into other areas of health care including health promotion. A medical technology
professional must be actively involved in reaching out to the community. There are many
ways by which the medical technology profession can help improve the lives of people.
Other health care professionals such as nurses and physicians are easily seen in community
outreach programs because of the nature of their professions. Medical technologists, as
valuable health care professionals, are also expected to do the same. The following are
some ways that medical technology professionals can help the community:

1.      Cooperate with other health care professionals in health promotion campaigns such as
promoting the ideal attitudes on hygiene, community sanitation, waste segregation, and
disease prevention.

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

3.      Offer free laboratory testing such as blood typing, urinalysis, fecalysis, blood sugar
testing, cholesterol testing, and other tests beneficial to the entire community.

4.      Collaborate with other health care professionals once diagnoses are done.

DEFINING THE PRACTICE OF OTHER LABORATORY PERSONNEL

The following is a list of other valuable laboratory personnel with various roles in the health
care delivery system, specifically in the area of laboratory medicine. It is important to note
that medical technologists work closely with these laboratory personnel in order to provide
accurate and precise laboratory results. The different roles of different laboratory personnel
are interconnected. It is important that all should work in harmony in order to provide the
best patient care.

Pathologist

            As defined in R.A. 5527

            A pathologist is a duly registered physician who is specially trained in medical 


laboratory medicine, or the gross and microscopic study and interpretation of tissues,
secretions and excretions of the human body and its functions in order to di disease, follow
its course, determine the effectively of treatment, ascertain cause of de and advance
medicine by means of research (Section 2, b.).

            A pathologist is always considered to head a clinical laboratory and monitor all
laboratory results. A laboratory result without the signature of a pathologist may not be
considered valid.

Medical Laboratory Technicians

            As defined in R.A. 5527:

            A medical laboratory technician is a person certified by and registered with the
Board of Medical Technology and qualified to assist a medical technologist and/or qualified
pathologist in the practice of medical technology as defined in the aforementioned act
(Section 2, d.).
            There are certain qualifications other than what is stated above to become a medical
technician provided that he or she satisfies the qualifications such that he or she:

a.       Failed to pass the medical technology licensure examination given by the Board of
Medical Technology but obtained a general rating of at least 70% and provided finally that a
registered medical laboratory technician when employed in the government shall have the
equivalent civil service eligibility not lower than the second grade;

b.      Passed the civil service examination for medical technicians given on March 21, 1969;
or

c.       Finished a two-year college course and has at least one (1) year experience of working
as a medical laboratory technician; provided that for every year of experience in college, two
(2) years of work experience may be substituted; and provided further, that the applicant
has at least ten (10) years of experience as medical laboratory technician as of the date of
approval of this decree.

Phlebotomist

            A phlebotomist is an individual trained to draw blood either for laboratory tests or
for blood donations. When only small quantities of blood are needed, a phlebotomist can
draw blood by simply puncturing the skin but when larger volumes of blood are needed,
venipuncture or even arterial puncture is done. Arterial collection can only be performed by
a specially trained phlebotomist. Nowadays, phlebotomy is a skill confined not only to
medical technologists but to other health care practitioners as well, provided that they were
given certification by a reputed certifying or training body.

            In the Philippines, a medical technologist is required to be skilled in phlebotomy.


Although, in other countries, phlebotomists need not get a degree (Cardona et al., 2015).
They are trained on the job and go through phlebotomy programs sponsored by
community colleges which take as little time as two months. After completing the program,
they may take an examination for them to be recognized as a certified phlebotomist by the
American Society for Clinical Pathology (ASCP), American Medical Technologist (AMT), and
the National Healthcareer Association (NHA).

Cytotechnologist

            A cytotechnologist is a laboratory personnel who works with the pathologist to


detect changes in body cells which may be important in the early diagnosis of diseases. This
is primarily done by examining microscopic slides of body cells for abnormalities or
anomalies in structures, indicating either benign or malignant conditions. A cytotechnologist
selects and sections minute particles of human tissue for microscopic study, using
microtomes and other equipment and employs stain techniques to make cell structures
visible or to differentiate its parts. The Papanicolaou (Pap) test and the H&E are the most
commonly employed staining techniques.

Histotechnologist

            A histotechnologist, also referred to as histotechnican, is a laboratory personnel


responsible for the routine preparation, processing, and staining of biopsies and tissue
specimens for microscopic examination by a pathologist (Cardona, 2015). Although there is
no formal training for histotechnologists in the Philippines, being a histotechnologist is
perceived to be a decent paramedical profession abroad. In the United States, one can
complete a histotechnician program accredited by the National Accrediting Agency for
Clinical Laboratory Science (NAACLS). This program usually takes a year to complete and
covers courses in chemistry, histology, immunology, biochemistry, and medical ethics.
Aspiring histotechnologists can also complete an associate degree program in a reputable
health facility that includes supervised histology training to gain an associate degree in
Applied Science (AAS) major in Histology.

Nuclear Medical Technologist

            A nuclear medical technologist is a health care professional who works alongside
nuclear physicians. Nuclear medical technologists apply their knowledge of radiation physics
and safety regulations to limit radiation exposure, prepare and administer
radiopharmaceuticals, and use radiation detection devices and other kinds of laboratory
equipment that measure the quantity and distribution of radionuclides deposited in the
patient or in the patient's specimen.

Toxicologist

            A toxicologist studies the effects of toxic substances on the physiological functions
of human beings, animals, and plants to develop data for use in consumer protection and
industrial safety programs. He or she also designs and conducts studies to determine
physiological effects of various substances on laboratory animals, plants, and human tissue,
using biological and biochemical techniques.

 UNit 3: MEDICAL TECHNOLOGY/ CLINICAL LABORATORY SCIENCE


EDUCATION

Introduction 

Medical technology education in the Philippines is governed and regulated by the


Commission on Higher Education (CHED) under CMO no. 13, series of 2017. The medical
technology program leads to a degree in Bachelor of Science in Medical Laboratory
Science/ Bachelor of Science in Medical Technology which is a four-year course with
professional licensure examination upon the completion of the required units. To become a
professional/practicing medical laboratory scientist/medical technologist, a graduate of this
program needs to pass the licensure examination in medical technology, following which a
license is granted by the Professional Regulation Commission by virtue of RA 5527 (Medical
Technology Act of 1969). A practicing and duly licensed medical technologist/ medical
laboratory scientist can then become a member of a professional organization, namely the
Philippine Association of Medical Technologists (PAMET) or the Philippine Association of
Schools of Medical Technology/Public Health (PASMETH), and enjoy the benefits and
Privileges extended by such organizations. In other countries, medical technology education
is regulated by the ministry of education, except those universities where the program is
accredited by the accreditation agency or enjoys autonomous status. There are international
professional organizations that can absorb registered medical technologists or clinical
laboratory scientists of other countries under the provision of a reciprocity clause.

Learning Outcomes

At the end of this unit, students will be able to:

1.      Define curriculum.

2.      Enumerate the different general education and professional courses included in the
Bachelor of Science in Medical Technology/Clinical  Laboratory Science.
3.      Discuss the importance of general education courses in the development of Medical
technologist/Clinical Laboratory Scientist.

4.      Discuss the basic concepts of Outcomes-based education.

Presentation of Contents

 Medical Technology Curriculum

The Commission on Higher Education (CHED) was established on May 18, 1994 through the
passage of Republic Act No. 7722, the Higher Education Act of 1992. CHED is the
government agency under the Office of the President of the Philippines that covers
institutions of higher education both public and private. It is tasked to organize and appoint
members of the technical panel for each discipline/program area. Under CHED is the
Technical Committee for Medical Technology Education (TCMTE) which is composed of
leading academicians and practitioners responsible for assisting the Commission in setting
standards among institutions offering Bachelor of Science in Medical Technology/Medical
Laboratory Science program and in monitoring and evaluating such institutions. The
BSMT/BSMLS program is considered one of the allied health programs (others, to name a
few, are Nursing,  Pharmacy, Physical Therapy, among others.).

The BSMT/BSMLS is a four-year program consisting of general education professional


courses that students are expected to complete within the first three years. Fourth year is
dedicated to the students' internship training in CHED-accredited to laboratories affiliated
with their college/department.          The Commission issued CHED Memorandum Order
(CMO) No. 13, series of 2017 (Policies, Standards, and Guidelines for the Bachelor of Science
in Medical Technology/ Medical Laboratory Science program) as a guide for institutions
offering the program, CMO contains the goals, program outcomes, performance indicators,
and the minimum course offerings (general education core courses, and professional
courses with allotted units) of the BSMT/BSMLS program. This new CMO is compliant with
the K-12 Curriculum Educational institutions offering the program are given certain leeway
in enhancing the curriculum for their program.

 The prescribed minimum number of units per course, and whether each course has a
laboratory or lecture component, are also indicated in the new CMO. One unit of lecture is
equivalent to one hour of class meeting every week. Thus, a 3-unit lecture course renders 3
hours of class meeting per week which is equivalent to 54 hours per semester (if one school
year is divided into two semesters, with each semester equivalent to 18 weeks). Principles of
Medical Laboratory Science 1 is an example of a 3-unit lecture without a laboratory
component. One unit of laboratory is equivalent to 3 hours of class meeting every week. An
example is Clinical Bacteriology which is a 5-unit course composed of 3 units of lecture and
2 units of laboratory. This is equivalent to 3 hours of lecture and 6 hours of laboratory work
(total of 54 lecture hours and 108 laboratory hours per semester).

 In the MT/MLS curriculum, the policy of taking prerequisites for some courses is followed. A
student taking the BSMT/BSMLS program must be aware of the courses he or she needs to
take in order to move on to more advanced courses in the curriculum. For example, before
taking the course Immunology and Serology, one should have already completed the
course Clinical Bacteriology.

 General Education Courses

General Education (GE) course offerings cut across different programs. These courses aim to
develop foundational knowledge, skills, values, and habits necessary for students to succeed
in life, to positively contribute to society, to understand the diversity of cultures, to gain a
bigger perspective and understanding of living with others, to respect differences in
opinions, to realize and accept their weaknesses and improve on them, and to further hone
their strengths. Thus, GE courses aim to develop humane individuals that have a deeper
sense of self and acceptance of others. The general courses included in the new CMO are

1.      Understanding the Self

2.      Readings in Philippine history

3.       The Contemporary World

4.       Mathematics in the Modern World

5.       Purposive Communication

6.       The Life and Works of Rizal

7.       Science, Technology, and Society

8.       Art Appreciation

9.      9. Ethics

Professional Courses

Professional courses are taken for learners to develop the knowledge, technical
competence, professional attitude, and values necessary to practice and meet the demands
of the profession. Critical thinking skills, interpersonal skills, collaboration, and teamwork are
also developed. Some of the professional courses are

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


Science, Laboratory Safety, and Waste Management

            This course deals with the basic concepts and principles related to the Medical
Technology/Medical Laboratory Science profession. Its emphasis is on the curriculum,
practice of the profession, clinical laboratories, continuing professional education, biosafety
practices, and waste management.

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


Phlebotomy

             Clinical Laboratory Assistance encompasses the concepts and principles of the
different assays performed in the clinical laboratory. Phlebotomy deals with the basic
concepts, principles, and application of the standard procedures in blood collection,
transport, and processing. It also involves the study of pre-analytic, analytic, and post-
analytic variables that affect reliability of test results.

3.      Community and Public Health for MT/MLS 1 Public Health for MT/MLS

            This course involves the study of the foundations of community health that include
human ecology, demography, and epidemiology. It emphasizes the promotion of
community, public, and environmental health and the immersion and interaction of students
with people in the community.
4.      Cytogenetics

            This course is focused on the study of the concepts and principles of heredity and
inheritance which include genetic phenomena, sex determination, and genetic defects
rooted in inheritance, among others. It also discusses the abnormalities and genetic
disorders involving the chromosomes and nucleic acids (DNA and RNA). Emphasis is given
to the analysis of nucleic acids and their application to medical science.

5.      Human Histology

            This course deals with the study of the fundamentals of cells, tissues, and oro with
emphasis on microscopic structures, characteristics, differences, and functi The laboratory
component of this course primarily deals with the microscopic identification and
differentiation of cells that make up the systems of the body.

6.      Histopathologic Techniques with Cytology

            This course covers the basic concepts and principles of disease processes, etiology
and the development of anatomic, microscopic changes brought about by the disease
process. It deals with the histopathologic techniques necessary for the preparation of tissue
samples collected via surgery, biopsy, and/or autopsy for macroscopic and microscopic
examinations for diagnostic purposes.

            Some of the tests that students perform for the laboratory component of the course
in a school-based laboratory are

•         Tissue processing techniques

•         Cutting of processed tissues

•         . Staining

•         Mounting of stained tissue for microscopic examination

•         Performing biosafety and waste management

7.      Clinical Bacteriology

            This course deals with the study of the physiology and morphology of bacteria and
their role in infection and immunity. Its emphasis is on the collection of or to specimen and
the isolation and identification of bacteria. It also covers antimicrobial susceptibility testing
and development of resistance to antimicrobial substances.

             Some of the procedures and tests that students perform for the laboratory Dos
component of the course in a school-based laboratory are .

•         Preparation of culture media

•         Collection of specimen

•         Preparation of bacterial smear

•          Staining of smear

•          Inoculation of specimen on culture media


•         Characterization of colonies of bacteria growing in culture media

•         Performing different biochemical tests for identification of bacteria.

•          Biosafety and waste management

•         Quality assurance and quality control

•         Antimicrobial susceptibility testing

8.      Clinical Parasitology

            This course is concerned with the study of animal parasites in human and their
medical significance in the country. Its emphasis is on the pathophysiology, epidemiology,
life cycle, prevention and control, and the identification of ova and/or adult worms and
other forms seen in specimens submitted for diagnostic purposes.

            Some of the procedures and tests that students perform for the laboratory
component of the course in a school-based laboratory are

·         Microscopic identification of diagnostic features of different groups of parasites


pathogenic to man (e.g., nematodes, trematodes, cestodes, protozoa, plasmodium, among
others)

·          Different methods of preparing smear for microscopic examination (direct fecal


smear, Kato-Katz, among others)

 9.      Immunohematology and Blood Bank

            This course tackles the concepts of inheritance, characterization, and laboratory
identification of red cells antigens and their corresponding antibodies. It also covers the
application of these antigens and/or antibodies in transfusion medicine and transfusion
reactions work-up.

             Some of the procedures and tests that students perform for the laboratory
component of the course in a school-based laboratory are:

 • ABO and Rh typing

 • Coombs test (direct and indirect Coombs)

 • Blood donation process

• Compatibility testing

• Transfusion reaction work-up

• Preparation of RBC suspension

10.  Mycology and Virology

            This course deals with the study of fungi and viruses as agents of diseases with
emphasis on epidemiology, laboratory identification and characterization, and prevention
and control.
11.  Laboratory Management

            This course looks into the concepts of laboratory management which are to the
planning, organizing, staffing, directing, and controlling as applied in clinical laboratory
setting. It also tackles the process of solving problems, quality assurance and quality control,
preparation of policy and procedure manuals, and other activities necessary to maintain a
well-functioning laboratory.

12.  Medical Technology Laws and Bioethics

            This course encompasses various laws, administrative orders, and other any legal
documents related to the practice of Medical Technology/Medical Laboratory Science in the
Philippines.

            Bioethics looks into the study of ethics as applied to health and health care delivery
and to human life in general. Different bioethical principles, philosophical principles, virtues
and norms, and the Code of Ethics of medical technologists are also discussed.

13.  Hematology 1

            This course deals with the study of the concepts of blood as a tissue. Formation,
metabolism of cells, laboratory assays, correlation with pathologic conditions, special
hematology evaluation are given emphasis. Quality assurance and quality control in
hematology laboratory as well as bone marrow studies are also discussed.

            Some of the procedures and tests that students perform for the laboratory -
component of the course in a school-based laboratory are:

·         Complete blood count (CBC)

·         Hematocrit blood test

·         Platelet count

·         Preparation of blood smear and staining

·          Red cell morphology

·          Erythrocyte sedimentation rate (ESR)

·          Fragility test

·          Erythrocyte indices

·          Reticulocyte count

·          Instrumentation

·          Osmotic fragility test

·         Quality assurance and quality control

·          Biosafety and waste management


14.  Hematology 2

            This course deals with the concepts and principles of hemostasis, and abnormalities
involving red blood cells (RBC), white blood cells (WBC), and platelets. Laboratory
identification of blood cell abnormalities, quantitative measurement of coagulation factors,
and disease correlation are emphasized.

            Some of the procedures and tests that students perform for the laboratory
component of the course in school-based laboratory are

·         Identification of abnormal RBC and WBC

·          Special staining techniques

·         Coagulation factor test (e.g., activated partial thromboplastin time (API, Prothrombin
time [PT], Bleeding time [BT), Clotting time P retraction time [CRT])

·         Instrumentation

15.  Clinical Microscopy

            This course focuses on the study of urine and other body fluids (excluding blood). It
includes the discussion of their formation, laboratory analyses, disease processes, and
clinical correlation of laboratory results.

            Some of the procedures and tests that students perform for the laboratory
component of the course in a school-based laboratory are:

·         Routine urinalysis (macroscopic, microscopic, chemical examinations)

·          Special chemical examination of urine

·         Examination of other body fluids (seminal fluid, gastric juice, cerebrospinal fluid)

·         Pregnancy tests

·          Chemical examination of stool specimens

16.  Clinical Chemistry 1

             This course encompasses the concepts and principles of physiologically active
soluble substances and waste materials present in body fluids, particularly in the blood. The
study includes formation, laboratory analyses, reference values and clinical correlation with
pathologic conditions. The course also looks into instrumentation and automation, quality
assurance, and quality control.

            Some of the procedures and tests that students perform for the laboratory
component of the course in a school-based laboratory are

·         Instrumentation

·         Quality assurance and quality control

·         Glucose determination
·         Lipid testing (triglyceride, lipoproteins)

·         Renal function tests (blood urea nitrogen (BUN), blood uric acid (BUA),creatinine]

·         Protein testing (total proteins, albumin, globulin)

·         Biosafety and waste management

17.  Clinical Chemistry 2

            This course is a continuation of Clinical Chemistry 1 and deals with the concepts and
principles of physiologically active soluble substances and waste materials present in body
fluids, particularly in the blood. It also covers the study of endocrine glands and hormones
and their formation, laboratory analyses, and clinical correlation. Therapeutic drug
monitoring and laboratory analysis of drugs and substances of abuse as well as toxic
substances are also emphasized.

            Some of the procedures and tests that students perform for the laboratory
component of the course in a school-based laboratory are:

·         Bilirubin test

·         Clinical enzymology (transferases, dehydrogenase, hydrolases)

·         Electrolyte testing

·         Hormone testing

·          Drug tests

18.  Seminars 1 and 2

            This course is taken during the student's fourth year in the program together
with the internship training. It deals with current laboratory analyses used in the dra oniqe
of medical technology.

19.  Molecular Biology and Diagnostics

            Molecular Biology deals with the nucleic acid and protein molecule interactive within
the cell to promote proper growth, cell division, and development. It covers the molecular
mechanisms of DNA replication, repair, transcription, translation, protein synthesis, and
gene regulation.

             This course is focused on the concepts, principles, and application of molecular
biology in clinical laboratory. It also deals with the application of different molecular e
techniques as tools in the diagnosis of diseases.

 Research Courses

Research courses required in the BSMT/BSMLS program are Research 1: Introduction to


Laboratory Science Research and Research 2: Research Paper Writing and
Presentation. Research 1 deals with the basic concepts and principles of research as applied
in Medical Technology/Clinical Laboratory Science. Ethical principles, as applied in research,
are also emphasized. Research 2, on the other hand, covers the methodology of the
research (approved in Research 1), writing the research paper in the format prescribed by
the institution and international research agencies for possible publication, and presentation
of the finished and completed research in a formal forum.

Clinical Internship Training

Clinical internship training is taken during the students' fourth year in the program. Only
those who have completed and passed all the academic and institutional requirements for
the first three years of the program, and other requirements as specified in the official
documents of the institution, college and/or departments are qualified for internship. Before
proceeding with the actual training, students are required to undergo physical and
laboratory examinations which include, but not limited to, complete blood count (CBC),
urinalysis, fecalysis, chest X-ray and/or sputum microscopy, Hepatitis B surface antigen
(HBsAg, and Hepatitis B surface antibody (HBsAb) screening, and drug testing (for
methamphetamine and cannabinoids). Proof of vaccination for hepatitis B is also a
requirement.

This intensive training aims to apply the theoretical aspects of the profession into practice.
Students are assigned to CHED-accredited clinical laboratories affiliated with their academic
institution on a 6-month or one-year rotation. This rotation ensures that all students
experience to work in the different sections of a clinical laboratory, namely clinical
chemistry, hematology, immunohematology (blood banking), clinical microscopy,
parasitology, microbiology, immunology and serology, histopathology/cytology, and other
emergen technologies.

The intern is required to render 32 hours of duty per week not exceeding a total of 1,664
hours in one year. This is broken down per section as follows (based on CMO 13 s. 2017):
Clinical Chemistry

300 hours Clinical Chemistry

200 hours Clinical Microscopy and Parasitology

250 hours Microbiology

300 hours Hematology

200 hours Blood Banking

100 hours Histopathologic techniques and Cytology

220 hours Immunology and Serology

40 hours Laboratory Management (collection, handling, transport, and receiving of


specimens, quality assurance, safety and waste management)

54 hours Phlebotomy for a TOTAL of 1,664 hours  

The academic institution is required to conduct an orientation to prospective interns


regarding the policies and guidelines on internship training as contained in the Internship
Training Manual.

 
Licensure Examination

The Medical Technologist Licensure Examination is conducted in order to identify graduates


who possess the basic qualifications or the minimum conceptual skills and technical
competencies to perform the tasks with minimum errors.

The Professional Regulation Commission (PRC) is the government agency, under the Office
of the President of the Philippines, tasked to administer licensure examinations to different
professionals. Meanwhile, the Professional Regulatory Board (PRB) for Medical
Technology/Medical Laboratory Science, under the PRC, is tasked to prepare and administer
the written licensure examinations for graduates qualified to take the examination. PRB is
composed of a chairperson, who must be a duly licensed pathologist, and two members
should be both registered medical technologists. All members of the PRB are required 
holders of PRC licenses. At present, the Medical Technologist Licensure Examination is
administered twice a year, on the months of March and August.

            Listed below are some of the provisions included in Republic Act 5527, "The
Technology Act of 1969," in relation to the licensure examination:

1.      The courses included in the licensure examination and their corresponding


percentages are as follows:

·         Clinical Chemistry 20%

·         Microbiology and Parasitology 20 %

·         Hematology 20 %

·         Blood Banking and Immunology and Serology 20%

·         Clinical Microscopy 10%

·         Histopathologic Techniques (MTLaws and Bioethics and Laboratory Management -


not  written in R.A. 5527, but are now included in the board exam) 10%

2.      To pass the exam, an examinee must:

·         receive a general weighted average of 75%

·         have no rating below 50% in any major courses, and

·         Pass in at least 60% of the courses computed according to their relative weights.

3.      If an examinee passed the examination and is 21 years old and above, he or she will be
issued a certificate of registration and a PRC card as a licensed medical technologist. If an
examinee is younger than 21 years old, he or she will register as a professional after his or
her 21st birthday.

4.       If an examinee failed to pass the licensure examination three times, he or she needs to
enroll in a refresher course before retaking the examination.

5.       If an examinee failed to pass the examination but garnered a general weighted
average of 70%-74%, he or she may apply for certification as a medical laboratory
technician.
 

Competency Skills of Medical Technologist//Clinical Laboratory Scientist in the


21st century

Program Goals and Learning Outcomes

All higher educational institutions (HEIS) offering any graduate and/or undergraduate
degree programs must have a written document stating the program goals, vision and
mission, objectives, and learning outcomes based on the institutions' philosophy.

Learning outcomes are general statements that define what the learner has to achieve.
These learning outcomes serve as the foundation of curriculum development and teaching
methodologies that shape a program. When learning outcomes are clearly stated, shared
responsibilities and accountabilities for learning are developed in both students and
teachers.

The learning outcomes of the Bachelor of Science in Medical Technology (BSMT)/ Bachelor
of Science in Medical Laboratory Science (BSMLS) program state the knowledge, skills,
values, and ethics that graduates of the program should demonstrate. Demonstration of
such outcomes will result in competent and skillful professionals who are ready to skillfully
perform the tasks of the profession enabling them to contribute to the welfare of the
country and to improve the quality of life of the people whom they serve.

            The program outcomes of the BSMT/BSMLS degree expect students to

1.      demonstrate knowledge and technical skills needed to correctly perform


laboratory testing and ensure reliability of test results

             Knowledge is comprised of facts, information, and concepts acquired through


experience and education. Knowledge is important in order to understand the task to be
accomplished-be it technical and/or management of a section or a whole laboratory. A
knowledgeable graduate must have the confidence and necessary competencies to
contribute towards the resolution of the problem or conflict at hand.

            Technical skills relate to the psychomotor domain of learning. Medical


technology/medical laboratory science practice is primarily concerned with the laboratory
analyses of specimens carried out with utmost consideration for reliability of test results. A
BSMT/BSMLS graduate should be able to perform the tests in each section of the
laboratory, to control possible sources of errors or variability, and to understand the
plausibility of test results. A graduate's technical skill will be employed in specimen
collection, transport, and processing, manual testing and automation of equipment,
molecular biology techniques, as well as in biosafety and waste management practices.

2.      be endowed with the professional attitude and values enabling them to work
with their colleagues and other members of the health care delivery system

            Attitude deals with the affective domain. Learning outcomes in this domain look into
the feelings, emotions, tone of voice, attitude, and disposition of a BSMT/BSMLS graduate
when confronted with favorable or unfavorable situations in the workplace. It also deals with
his or her motivation to further improve himself or herself; how he or she reacts to criticism,
rejection, and praise; and his or her enthusiasm and desire vito contribute to the well-being
of the stakeholders.
3.      demonstrate critical thinking and problem solving skills when confronted with to
situations, problems, and conflicts in the practice of their profession

            Critical thinking is the ability of an individual to objectively and systematically


analyze, without bias, facts and information to come up with reasonable decisions and to
guide behavior. Problem solving involves the detailed analysis of the problem at hand by
focusing on present facts and information before making a decision. Decision making
entails one's ability to gather and synthesize facts, information, and opinions about the
problem at hand. It also involves looking into alternative courses of action to be undertaken
at the shortest time possible, even under extreme pressure. After a decision is made, there is
a need to monitor the effect and importance of the decision on the department or the
organization as a whole. Corrective activities should be instituted if the desired outcomes
are not attained.

            These skills are necessary for one to function well in the workplace as solving
problems and making decisions are constant.

4.      actively participate in self-directed life-long learning activities to be update with


the current trends in the profession

            The emergence and re-emergence of infectious agents, changes in demographics


demands of patients for efficient health care services, changes in medical technologies, state
and local legislations on the BSMT/BSMLS practice, and clinical laboratory personnel taking
more complex roles are some of the issues in the medical technology profession. To address
these issues, clinical laboratories must always be updated with the current trends and
employ the necessary changes. The education of the medical technologists/medical
laboratory scientists is part of the upgrade. Being a BSMT/BSMLS graduate does not entail
that the process of learning has already been completed and acquired. MT/MLS practice
involves a state of constant learning and re-learning to efficiently carry out the
responsibilities and accountabilities of being a medical technology professional.

            Thus, there is a need to engage in self-directed learning to be updated with the


constant changes in the medical technology practice. It is also ideal for one to take part in
training programs, workshops, and even enroll in graduate programs related to the
profession.

5.      actively participate in research and community-oriented activities

            Research is the systematic and organized study of materials to come up with new
conclusions or to establish facts. It involves experimentation, and gathering and analyzing
data to solve a problem or reach a conclusion. Research involves identifying a problem or
topic, using appropriate methods to gather data, analyzing, and interpreting data, and
disseminating research results through publication and paper presentations.

In community-oriented activities, a BSMT/BSMLS can be involved in planning, organizing,


and leading institution- and/or hospital-based activities. The activities may include blood
sugar testing, routine urinalysis, routine stool examination, and other basic laboratory tests
with an end-in-view of improving quality of life of the target community.

6.      be endowed with leadership skills

A leader sets the direction of a group for it to achieve its full potential while having a
consolidated vision toward the attainment of goals and objectives. A leader is someone who
has excellent communication skills, motivates and inspires others, and is not afraid to
develop others who may end up better than him or her.

No one is born a leader. Becoming an effective leader entails learning through experiences
that include failures inside and that include failures inside and outside the academic and
work environment.

7.      demonstrate collaboration, teamwork, integrity, and respect when working in a


multicultural environment

            Collaboration and teamwork are two important social skills necessary to work in a

complex and, at times, multicultural environment like the clinical laboratory Collaboration
means working together with multiple individuals and finding a common ground to work
toward achieving a set goal. Likewise, working with others in a team means working with
people you disagree with but coming to terms with such disagreements by sharing a
common goal. It requires listening close paying attention to what others contribute to the
team.

 Employment opportunities for the graduates of the program

Job Opportunities for the Graduate of the Program

          A BSMT/BSMLS graduate can practice as a/an

·        Medical technologist/clinical laboratory scientist in a hospital-based or non-hospital


based clinical laboratory

·         Histotechnologist in an anatomical laboratory

·         Researcher/research scientist

·         Member of the academe (faculty, clinical instructor. clinical coordinator,


dean/ department chair, academic coordinator)

·          Perfusionist

·         Molecular scientist

·          Diagnostic product specialist

·          Public health practitioner

·          Health care leaders

 A graduate may also practice in the following fields

·         Molecular Biology

·         Public Health and Epidemiology

·          Veterinary Laboratory Science

·          Food and Industrial Microbiology


·         Veterinary Sciences

·          Forensic Science

·          Nuclear Medicine/Science

·         Health Facility Administration and Management

·          Quality Managements

 Unit 4 : NATURE OF THE CLINICAL LABORATORY

Clinical laboratory is an essential component of health institutions. Its main task is to


provide accurate and reliable information to medical doctors for the diagnosis, prognosis,
treatment, and management of diseases. Seventy percent of all decisions performed
by doctors are based on laboratory test results, thus the need for accurate and
reliable results. The clinical laboratory is also actively involved in research, community
outreach programs, surveillance, and infection control in the hospital and community
settings, information and evaluation of the applicability of current and innovative diagnostic
technologies. Thus, the medical technologist/clinical laboratory scientist serves as the
integral er of medical doctors and is an important member of the health care delivery
system.

The clinical laboratory is the place where specimens (e.g., blood and other body fluids, sues,
feces, hair, nails) collected from individuals are processed, analyzed, preserved, and properly
disposed. Clinical laboratories vary according to size, function, and the complexity of tests
performed.

A medical technologist/clinical laboratory scientist plays a very significant role in the


performance of laboratory testing and ensuring the reliability of test results. Assays
undertaken in the clinical laboratory in the past were described as manual, taxing, labor-
intensive, and time-consuming. Currently, with the advent of automation, assays are less
laborious, with shortened turnaround time (TAT). Also, test procedures are ensured to
produce more reliable results. In the near future, there will be more changes in the clinical
laboratory. Changes may be due to shifting demographics, emergence of new and re-
emergence of infectious and non-infectious diseases, demand for a more efficient and
effective workflow, and new government institutional policies. These factors can usher in
change in the activities done in the laboratory.

At the end of this unit, students will be able to:

  1.      Discuss the history of medical technology on a global context.

2.      Discuss the history of medical technology in the United States.

3.      Discuss the history of medical technology in the Philippines.

4.      Identify important personalities that played a significant role in the progress of


medical technology profession.

5.      Discuss the historical milestones in Medical Technology.


Presentation of Contents

Clinical Laboratory

          Clinical laboratory is an essential component of health institutions. Its main task is to


provide accurate and reliable information to medical doctors for the diagnosis, prognosis,
treatment, and management of diseases. Seventy percent of all decisions performed
by doctors are based on laboratory test results, thus the need for accurate and
reliable results. The clinical laboratory is also actively involved in research, community
outreach programs, surveillance, and infection control in the hospital and community
settings, information and evaluation of the applicability of current and innovative diagnostic
technologies. Thus, the medical technologist/clinical laboratory scientist serves as the
integral er of medical doctors and is an important member of the health care delivery
system.

            The clinical laboratory is the place where specimens (e.g., blood and other body
fluids, sues, feces, hair, nails) collected from individuals are processed, analyzed, preserved,
and properly disposed. Clinical laboratories vary according to size, function, and the
complexity of tests performed.

            A medical technologist/clinical laboratory scientist plays a very significant role in the
performance of laboratory testing and ensuring the reliability of test results. Assays
undertaken in the clinical laboratory in the past were described as manual, taxing, labor-
intensive, and time-consuming. Currently, with the advent of automation, assays are less
laborious, with shortened turnaround time (TAT). Also, test procedures are ensured to
produce more reliable results. In the near future, there will be more changes in the clinical
laboratory. Changes may be due to shifting demographics, emergence of new and re-
emergence of infectious and non-infectious diseases, demand for a more efficient and
effective workflow, and new government institutional policies. These factors can usher in
change in the activities done in the laboratory.

Classifications of Clinical Laboratories

According to Function

1. Clinical Pathology is a clinical laboratory that focuses on the areas of clinical chemistry,
immunohematology and blood banking, medical microbiology, immunology and serology,
hematology, parasitology, clinical microscopy, toxicology, therapeutic drug monitoring, and
endocrinology, among others. It is concerned with the diagnosis and treatment of diseases
performed through laboratory testing of blood and other body fluids.

2. Anatomic Pathology is a clinical laboratory that focuses on the areas of histopathology,


immunohistopathology, cytology, autopsy, and forensic pathology among others. It is
concerned with the diagnosis of diseases through microscopic examination of tissues and
organs.

According to Institutional Characteristics

1. An institution-based is a clinical laboratory that operates within the premises or part of


an institution such as a hospital, school, medical clinic, medical facility for over workers and
seafarers, birthing home, psychiatric facility, drug rehabilitation center and others. Hospital-
based clinical laboratories are the most common example of institution-based laboratories.
2. A free-standing clinical laboratory is not part of an established institution. The most
common example is a free-standing out-patient clinical laboratory.

According to Ownership

 1. Government-owned clinical laboratories are owned, wholly or partially, by national or


local government units. Examples are the clinical and anatomical laboratories of DOH run
government hospitals like the San Lazaro Hospital, Jose R. Reyes Memorial Medical Center,
University of the Philippines Philippine General Hospital and local government run hospital-
based clinical laboratories of the Ospital ng Maynila Medical Center Sta. Ana Hospital, and
Bulacan Medical Center.

2. Privately-owned clinical laboratories are owned, established, and operated by an


individual, corporation, institution, association, or organization. Examples are St. Luke's
Medical Center, Makati Medical Center, and MCU-FDTMF Hospital

According to Service Capability

1. Clinical laboratories under the primary category are licensed to perform basic, routine


laboratory testing, namely, routine urinalysis, routine stool examination, routine hematology
or complete blood count that includes hemoglobin, hematocrit, WBC and RBC count, WBC
differential count and qualitative platelet count, blood typing, and Gram staining (if
hospital-based). Equipment requirements are, but not limited to, microscopes, centrifuge,
hematocrit centrifuge. Space requirement is at least 10 square meters.

 2. Clinical laboratories secondary category (Hospital and non-hospital-based) are licensed


to perform laboratory tests being done by the primary category clinical laboratories along
with routine clinical chemistry tests like blood glucose concentration, blood urea nitrogen,
blood uric acid, blood creatinine, cholesterol determination, qualitative platelet count, and if
hospital-based, Gram stain, KOH mount, and crossmatching. A minimum requirement of 20
square meters is needed for the floor area of this type of laboratory, Personnel requirement
depends on the workload. Minimum equipment requirements are microscopes, centrifuge,
Hematocrit centrifuge, semiautomated chemistry analyzers, autoclave, incubator, and oven.

3.  Clinical laboratories under the tertiary category (Hospital and non-hospital based) are


licensed to perform all the laboratory tests performed in the secondary category laboratory
plus (1) immunology and serology (e.g., NS1-Ag for rapid plasma reagin, Treponema
pallidum particle agglutination tests); microbiology, bacteriology, and mycology (e.g.,
differential staining techniques, culture and identification of bacteria and fungi from
specimens, antimicrobial susceptibility testing); (3) special clinical chemistry (e.g., clinical
enzymology, therapeutic monitoring, markers for certain diseases); (4) special hematology
(e.g., bone marrow studies, special staining for abnormal blood cells, red cell morphology);
and immunohematology and blood banking (e.g.. blood donation program, antibody
identification, preparation of blood components).

            Tertiary laboratories have a minimum floor area requirement of at least 60 square
meters. Equipment requirements include those seen in secondary category laboratories
along with automated chemistry analyzer, biosafety cabinet class II, serofuge, among others.

4. National Reference Laboratory is a laboratory in a government hospital designated by


the DOH to provide special diagnostic functions and services for certain diseases. These
functions include referral services, provision of confirmatory testing, assistance for research
activities, implementation of External Quality Assurance Programs (EQAP) of the
government, resolution of conflicts regarding test results of different laboratories, and
training of medical technologists on certain specialized procedures that require
standardization.

Laws on the Operation, Maintenance, and Registration of Clinical Laboratories in the


Philippines

Republic Act No. 4688

            An act regulating the operation and maintenance of clinical laboratories and
requiring the registration of the same with the department of health, providing
penalty for the violation thereof, and for other purposes

SECTION 1. Any person, firm or corporation, operating and maintaining a clinical laboratory
in which body fluids, tissues, secretions, excretions and radioactivity from beings or animals
are analyzed for the determination of the presence of pathologic organisms, processes
and/or conditions in the persons or animals from which they were obtained, shall register
and secure a license annually at the office of the Secretary of Health: provided, that
government hospital laboratories doing routine or minimum laboratory examinations shall
be exempt from the provisions of this section if their services are extensions of government
regional or central laboratories.

SECTION 2. It shall be unlawful for any person to be professionally in-charge of a registered


clinical laboratory unless he is a licensed physician duly qualified in laboratory medicine
authorized by the Secretary of Health, such authorization to be renewed annually. No lice
shall be granted or renewed by the Secretary of Health for the operation and maintenance:
of a clinical laboratory unless such laboratory is under the administration, direction and
supervision of an authorized physician, as provided for in the preceding paragraph.

SECTION 3. The Secretary of Health, through the Bureau of Research and Laboratories s be
charged with the responsibility of strictly enforcing the provisions of this Act and shall
authorized to issue such rules and regulations as may be necessary to carry out its
provisions

SECTION 4. Any person, firm or corporation who violates any provisions of this Act or the
rules and regulations issued thereunder by the Secretary of Health shall be punished with
imprisonment for not less than one month but not more than one year, or by a fine of not
less than one thousand pesos nor more than five thousand pesos, or both such fine and
imprisonment, at the discretion of the court.

SECTION 5. If any section or part of this Act shall be adjudged by any court of competent
jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder
thereof. SECTION 6. The sum of fifty thousand pesos, or so much thereof as may be
necessary, is hereby authorized to be appropriated, out of any funds in the National
Treasury not otherwise appropriated, to carry into effect the provisions of this Act.

SECTION 7. All Acts or parts of Acts which are inconsistent with the provisions of this Act are
hereby repealed. SECTION 8. This Act shall take effect upon its approval.

Approved, June 18, 1966.

 
Administrative Order No. 59 s. 2001

Rules and Regulation Governing the Establishment, Operation and Maintenance of


Clinical Laboratories in the Philippines

Section 1: Title This Administrative Order shall be known as the "Rules and Regulations
Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the
Philippines.”

 Section 2: Authority

These rules and regulations are issued to implement R.A. 4688: Clinical Laboratory Law
consistent with E.O. 102 series 1999: Redirecting the Functions and Operations of the
Department of Health. The Department of Health (DOH), through the Bureau of Health
Facilities and Services (BHFS) in the Health Regulation Cluster, shall exercise the regulatory
functions under these rules and regulations.

Section 3: Purpose These rules and regulations are promulgated to protect and promote the
health of the people ensuring availability of clinical laboratories that are properly managed
with adequate with effective and efficient performance through compliance with quality
standards.

Section 4. Scope

1.      These regulations shall apply to all entities performing the activities and functions
Clinical laboratories which shall include the examination and analysis of any or all samples of
human and other related tissues, fluids, secretions, radioactive, or other related tissue, fluids,
secretions, radioactive, or other materials from the human body for the determination of the
existence of pathogenic organisms, pathologic processes or conditions in the person from
whom such samples are obtained.

2.      These regulations do not include government laboratories doing laboratory


examinations limited to acid fast bacilli microscopy, malaria screening and cervical cancer
screening, provided their services are declared as extension of a licensed government
clinical laboratory

Section 5: Classification of Laboratories

1.      Classification by Function

·         Clinical Pathology - includes Hematology, Clinical Chemistry, Microbiology,


Parasitology, Mycology, Clinical Microscopy, Immunology and Serology,
Immunohematology, Toxicology and Therapeutic Drug Monitoring and other similar
disciplines.

·         Anatomic Pathology - includes Surgical Pathology, Immunohistopathology, Cytology,


O Autopsy and Forensic Pathology. 2. Classification by Institutional Character

2.      Classification by Institutional Character

·         Hospital-based laboratory - a laboratory that operates within a hospital

·          Non-hospital-based laboratory - a laboratory that operates on its own

3.      Classification by Service Capability


·         Primary - provides the minimum service capabilities such as: (1) Routine Hematology
(Complete Blood Count or CBC) - includes Hemoglobin Mass Concentration, Erythrocyte
Volume Fraction (Hematocrit), Leucocyte Number Concentration (WBC count) and
Leucocyte Type Number Fraction (Differential Count), Qualitative Platelet Determination (2)
Routine Urinalysis (3) Routine Fecalysis (4) Blood Typing - hospital-based (5) Quantitative
Platelet Determination - hospital-based

·         Secondary - provides the minimum service capabilities of a primary category and


following: (1) Routine Clinical Chemistry - includes Blood Glucose Substance Concentra
Blood Urea Nitrogen Concentration, Blood Uric Acid Substance Concentration, Blood
Creatinine Concentration, Blood Total Cholesterol Concentration (2) Crossmatching

·         Tertiary - provides the secondary service capabilities and the following: (1) Special
Chemistry (2) Special Hematology (3) Immunology/Serology (4) Microbiology

Section 6: Policies

1. An approved permit to construct and design layout of a clinical laboratory shall be


secured form the BHFS prior to submission of an application for a Petition to Operate

2. No clinical laboratory shall be constructed unless plans have been approved and
construction permit issued by the BHFS.

 3. A clinical laboratory shall operate with a valid license issued by BHFS/CHD, based on
compliance with the minimum licensing requirements (Annex A).

4. The clinical laboratory shall be organized and managed to provide effective and efficient
laboratory services.

5. The clinical laboratory shall provide adequate and appropriate safety practices for its
personnel and clientele.

Section 7: Requirements and Procedures for Application of Permit to Construct and License
to Operate

1.      Application for Permit to Construct

 The following are the documents required:

·         Letter of Application to the Director of BHFS

·          Four (4) sets of Site Development Plans and Floor Plans approved by an architect
and/or engineer.

·         DTI/SEC Registration (for private clinical laboratory)

2.      Application for New License

            A duly notarized application form “Petition to Establish, Operate and Maintain a
Clinical Laboratory”, shall be filed by the owner or his duly authorized representative at the
BHFS.
3.      Application for renewal of license

            A duly notarized application form "Application for Renewal of License to Establish,
Operate and Maintain a Clinical Laboratory" shall be filed by the owner or his duly
authorized representative at the respective CHD.

a.       Renewal of License:

            Application for renewal of license shall be filed within 90 days before the expiry date
of the license described as follows:

 NCR January to March

1, 2, 3 & CAR February to April

4,5 & 6 March to May

7, 8 & 9 April to June

10, 11, 12, CARAGA & ARMM May to July

4.      Permit and License Fees

·         A non-refundable license fee shall be charged for application for permit to construct,
and for license to operate a government and private clinical laboratory.

·          A non-refundable fee shall be charged for application for renewal of license to
operate.

·          All fees shall be paid to the Cashier of the BHFS/CHD. Cud. All fees shall follow the
current prescribed schedule of fees of the DOH.

5.      Penalties

1.      A penalty of one thousand pesos (P1,000.00) for late renewal shall be charged in
addition to the renewal fee for all categories if the application is filed during the next two (2)
months after expiry date.

2.       An application received more than two (2) months after expiry date shall be fined one
hundred pesos (P100.00) for each month thereafter in addition to the P1,000.00 penalty

6.      Inspection

a. Each license shall make available to the Director of the BHFS/CHD or his duly authorized
representative(s) at any reasonable time, the premises and facilities where the laboratory
examinations are being performed for inspection.

 b. Each license shall make available to the Director of the BHFS/CHD or his duly authorized
representative(s) all pertinent records.

c. Clinical laboratories shall be inspected every two (2) years or as necessary.


 7.      Monitoring

a. All clinical laboratories shall be monitored regularly and records shall be monitored
regularly and records shall be made available to determine compliance with these rules and
regulations.

b. The Director of the BHFS/CHD or his authorized representative(s) shall be allow to


monitor the clinical laboratory at any given time. C. All clinical laboratories shall make
available to the Director of the BHFS or his duly authorized representative(s) records for
monitoring.

8.      Issuance of License

The license shall be issued by the Director of the CHD or his authorized representative if the
application is found to be meritorious.

9.      Terms and Conditions of License

o   The license is granted upon compliance with the licensing requirements.

o    The license is non-transferable.

o    The owner or authorized representative of any clinical laboratory desiring to transfer a


licensed clinical laboratory to another location shall inform the CHD in writing at least 15
days before actual transfer.

o    The laboratory in its new location shall be subject to re-inspection and shall comply with
the licensing requirements. e. An extension laboratory shall have a separate license.

o    Any change affecting the substantial conditions of the license to operate a laboratory
shall be reported within 15 days in writing by the person(s) concerned, to the BHFS/ CHD for
notation and approval. Failure to do so will cause the revocation of the license of the clinical
laboratory.

o    The clinical laboratory license must be placed in a conspicuous location/area within the
laboratory.

Section 8: Violations

1. The license to operate a clinical laboratory shall be suspended or revoked by the


Secretary of Health upon violation of R.A. 4688 or the Rules and Regulations issued in
pursuance thereto.

2. The following acts committed by the Owner, President, Managers, Board of


Trustees/Director, Pathologist or its personnel are considered violations.

o   Operation of a clinical laboratory without a certified pathologist or without a registered


medical technologist

o    Change of ownership, location, head of laboratory or personnel without informing the


BHFS and/or the CHD

o   Refusal to allow inspection of the clinical laboratory by the person(s) authorized by the
BHFS during reasonable hours
o    Gross negligence

o    Any act or omission detrimental to the public

3.The Provincial, City and Municipal Health Officers are authorized to report to the CHD and
BHFS the existence of unlicensed clinical laboratories or any private party performing
laboratory examinations without proper license and/or violations to these rules and
regulations.

Section 9: Investigation of Charges or Complaints

The BHFS/CHD or his duly authorized representative(s) shall investigate the complaint and
verify if the laboratory concerned or any of its personnel is guilty of the charges.

1.      If upon investigation, any person is found violating the provision of R.A. 4688, or any
of these rules and regulations, the BHFS/CHD or his duly authorized representative(s) shall
suspend, cancel or revoke for a determined period of time the license, as well as the
authority of the offending person(s), without prejudice to taking the case to judicial
authority for criminal action.

2.       Any person who operates a clinical laboratory without the proper license from the
Department of Health shall upon conviction be subject to imprisonment for not less than 1
month but not more 1 year or a fine of not less than P1,000.00 and not more than P5,000.00
or both at the discretion of the court. Provided, however, that if the offender is a firm or
corporation, the Managing Head and/or owner/s thereof shall be liable to the penalty
imposed herein.

3.       Any Clinical Laboratory operating without a valid license or whose license has been
revoked/cancelled shall be summarily closed upon order issued by the BHFS/CHD or his
duly authorized representative. The BHFS/CHD may seek the assistance of the law
enforcement agency to enforce the closure of any clinical laboratory.

4.       The closure order issued by the DOH shall not be rendered ineffective by any
restraining order and injunction order issued by any court, tribunal or agency or
instrumentalities.

Section 10: Modification and Revocation of License

1.      A license maybe revoked, suspended or modified in full or in part for any material false
statement by the applicant, or as shown by the record of inspection or for a violation of, or
failure to comply with any of the terms and conditions and provisions of these rules and
regulations.

2.       No license shall be modified, suspended or revoked unless prior notice has been
made and the corresponding investigation conducted except in cases of willful, or repeated
violations hereof, or where public health interest or safety requires otherwise.

Section 11: Repealing Clause

            These rules and regulations shall supersede all other previous official issuances
hereof

Section 12: Publication and List of Licensed Clinical Laboratories


            A list of licensed clinical laboratories shall be published annually in a newspaper of
circulation.

Section 13: Effectivity

            These rules and regulations shall take effect 15 days after its publication in the
Official c. or in a newspaper of general circulation.

ANNEX A

Technical Standards and Minimum Requirements

          The clinical laboratory shall be organized to provide effective and efficient laboratory
services.

a.       STAFFING

1)      The clinical laboratory shall be managed by a licensed physician certified by the

Philippine Board of Pathology.

In areas where pathologists are not available, a physician with three (3)  months training on
clinical laboratory medicine, quality control and laboratory management, may manage a
primary/secondary category clinical laboratory. The BHFS shall certify such training.

2)      The clinical laboratory shall employ qualified and adequately train personnel.

 a. A clinical laboratory shall have sufficient number of registered medical technologists
proportional to the workload and shall be available at all times during hours of laboratory
operations. For hospital-based clinical laboratory, there shall be at least one registered
medical technologist per shift to cover the laboratory operation.

3) There shall be staff development and appropriate continuing education program


available at all levels of the organization to upgrade the knowledge, attitudes and skills of
staff.

II. PHYSICAL FACILITIES

·         The clinical laboratory shall be well-ventilated, adequately lighted, clean and safe.

·          The working space shall be sufficient to accommodate its activities and allow for
smooth and coordinated work flow.

·          There shall be an adequate water supply.

·          The working space for all categories of clinical laboratories (both hospital and non-
hospital-based) shall have at least the following measurements:

Primary 10 sqm

            Secondary 20

            Tertiary 60

III. EQUIPMENT/INSTRUMENTS
·         There shall be provisions for sufficient number and types of appropriate
equipment/instruments in order to undertake all the activities and laboratory examinations.
This equipment shall comply with safety requirements.

·          For other laboratory examinations being performed, the appropriate equipment


necessary for performing such procedures shall be made available.

IV. GLASSWARES/REAGENTS/SUPPLIES

All categories of clinical laboratories shall provide adequate and appropriate glassware,
reagents and supplies necessary to undertake the required services.

V. WASTE MANAGEMENT

 There shall be provisions for adequate and efficient disposal of waste following guidelines
of the Department of Health and the local government. (Copies of which are available at
respective CHDs and DOH-BHFS and local government offices)

VI. QUALITY CONTROL PROGRAM

All clinical laboratories shall have a functional Quality Assurance Program

1. Internal Quality Control Program

o   There shall be a documented, continuous competency assessment program for all


laboratory personnel.

o    The program shall provide appropriate and standard laboratory methods, reagents and
supplies and equipment.

o    There shall be a program for the proper maintenance and monitoring of all equipment.

o    The program shall provide for the use of quality control reference materials.

2. External Quality Control Program

o   All clinical laboratories shall participate in an External Quality Assurance Program given
by designated National Reference Laboratories and/or other recognized reference
laboratories.

o    A satisfactory performance rating given by a National Reference Laboratory shall be one
of the criteria for the renewal of license.

o    Any refusal to participate in an External Quality Assurance Program the designated


National Reference Laboratories shall be one of the suspension/revocation of the license of
the laboratory.

VII. REPORTING

            Laboratory requests shall be construed as consultation between the physician and
the Pathologist of the laboratory and as such laboratory results released accordingly.

·         All laboratory reports on various examinations of specimens shall bear the sign of the
registered medical technologist and the Pathologist and duly sign both.
·          No person in the clinical laboratory shall issue a report, orally or in writing whole or
portions thereof without a directive from the Pathologist authorized associate to the
requesting physician or his authorized representative except in emergency cases when the
results may be released as authorized by the Pathologist.

VIII. RECORDING

There shall be a system of accurate recording to ensure quality results.

·         There shall be an adequate and effective system of recording requests and reports of
all specimens submitted and examined.

·          There shall be provisions for filing, storage and accession of all reports.

·         All laboratory records shall be kept on file for at least one (1) year. a. Records of
anatomic and forensic pathology shall be kept permanently in the laboratory.

IX. LABORATORY FEES

The laboratory and professional fees to be charged for laboratory examination shall be at
the prevailing rates.

·         The rates shall be within the range of the usual fees prevailing at the time and the
particular place, taking into consideration the cost of testing and quality control of various
laboratory procedures.

·          Professional services rendered to the patient in the performance of special


procedures or examinations shall be charged separately and not included in the laboratory
fee/s.

Sections of the Clinical Laboratory

            A clinical laboratory is made up of different sections cohesively and comprehensively


performing different activities and procedures for each specimen collected from patients to
produce reliable test results. At the forefront of these activities are the clinical laboratory
namely the pathologists, medical technologists/clinical laboratory scientists, phlebotomists,
and other laboratory personnel.

Clinical Chemistry

            This section is intended for the testing of blood and other body fluids to quantify
essential soluble chemicals including waste products useful for the diagnosis of certain
diseases. Blood and urine are the two most common body fluids subjected for analyses in
this section. Examples of tests performed in this section are fasting blood sugar (FBS) and
glycosylated hemoglobin (HbA1c) for the diagnosis of diabetes; total cholesterol including
high- and low density lipoproteins (HDL and LDL); triglycerides (TAG) that can be used for
the diagnosis of cardiovascular diseases; blood uric acid (BUA); blood urea nitrogen (BUN);
creatinine for diagnosis of diseases involving the kidney; total protein (TP); albumin;
electrolytes (e.g., Sodium, Potassium, Chloride); clinical enzymology (e.g., aminotransferase,
creatinine kinase, etc.).

            In terms of the number of tests performed, this section is considered to be one of
the busiest. In majority of tertiary level clinical laboratories, this section is characterized as a
state-of-the-art, fully automated facility. In some laboratories, hormone in the blood and
urine are also measured under endocrinology. Thyroid hormones tests include thyroid
stimulating hormone (TSH), T3 and T4 (triodothyronine and thyroxine, respectively); other
tests involving estrogen, prolactin, and testosterone. Other laboratories also have
Toxicology and Drug Testing sections where therapeutic drug monitoring tests for
prohibited drugs are performed.

            Internal Quality Assurance (IQA), Continuous Quality Improvement (CQA), and
participation in National External Quality Assurance Program (NEQAP) are important
activities that medical technologists perform and are responsible for.

Microbiology

            This section is subdivided into four sections: bacteriology, mycobacteriology, myco
and virology. At present, the work in this section is more focused on the identification of
bacteria and fungi on specimens received. Specimens usually submitted are blood and other
body fluids, stool, tissues, and swabs from different sites in the body.

            Tests include the microscopic visualization of microorganisms after staining, isolation
and identification of bacteria (aerobes and anaerobes) and fungi using varied culture media
and different biochemical tests, and at times, antigen typing, and antibacterial susceptibility
testing. Other activities performed in this section include the preparation of culture media
and stains, quality assurance and control, infection control, and biosafety and proper waste
disposal. Mycobacteriology looks into the identification of mycobacterium (e.g.-
Mycobacterium tuberculosis) from the specimens submitted. Although not as automated as
clinical chemistry, automated instruments are available such as those used for blood culture
and antimicrobial susceptibility testing.

Hematology and Coagulation Studies

                        This section deals with the enumeration of cells in the blood and other body
fluids (e.g-CSF, pleural fluid, etc.). The examinations done in this section include complete
blood count globin, hematocrit, WBC differential count, red cell morphology and cell
indices, quantitative platelet count, total cell count and differential count, blood smear
preparation, for other body fluids. Coagulation studies focus on blood testing for the
determination of various coagulation factors.

            There are also developments and innovations that contribute to the automation of
activities in this section. Automated hematology analyzers are currently available in the
market. Bone marrow examination using automated analyzers is also conducted in this
section.

Clinical Microscopy

            There are two major areas in this section of the laboratory. The first area is a to
routine and other special examinations of urine such as macroscopic examination:
determine color, transparency, specific gravity, and pH level, and microscopic examination
detect presence of abnormal cells and/or parasites as well as to quantify red cells and a and
other chemicals found in urine. Examination of other body fluids is also performed area. The
second area is assigned to the examination of stool or routine fecalysis. Determination and
identification of parasitic worms and ova are the primary activities in this area.

Blood Bank/Immunohematology
            Blood typing and compatibility testing are the two main activities performed in this
ion. Screening for all antibodies and identification of antibodies as well as the blood
components used for transfusion are also conducted in this section. This section is
considered as the most critical in the clinical laboratory.

            In hospital-based clinical laboratories, blood donation activities prompt other


activities such as donor recruitment and screening, bleeding of donor, and post-donation
care.

Immunology and Serology

            Analyses of serum antibodies in certain infectious agents (primarily viral performed
in this section. Hepatitis B profile tests, serological tests for syphilis, and hepatitis C and
dengue fever are some examples of antibody screening tests. Similar to Chemistry and
Hematology sections, automated analyzers are commonly used in this when performing
different serological tests.

Anatomic Pathology

Section of Histopathology/Cytology

            Activities performed in this section include tissue (removed surgically as in bi and
autopsy) processing, cutting into sections, staining, and preparation for micro examination
by a pathologist.

Specialized Sections of the Laboratory

Immunohistochemistry

            It is a specialized section of the laboratory that combines anatomical, clinical, and
biochemical techniques where antibodies (monoclonal and polyclonal) bounded to enzymes
and fluorescent dyes are used to detect presence of antigens in tissue. This is useful in the
diagnosis of some types of cancers by detecting the presence of tumor-specific antigens,
oncogenes, and tumor suppressor genes. It can also be used to assess the responses of
patients to cancer therapy as well as diagnosis of certain neurodegenerative disorders.

Molecular Biology and Biotechnology

            One of the exciting developments in medical technology is molecular biology and
biotechnology diagnostics. Primarily using different enzymes and other reagents, DNA and
RNA are identified and sequenced to detect any pathologic conditions/disease processes.
The most common technique currently in use is the polymerase chain reaction (PCR). This
technique has contributed to scientific advancements in laboratory research and is useful for
a number of clinical techniques such as screening genetic indicators of disease and
diagnosis of cancer and infectious diseases.

Laboratory Testing Cycle

            The laboratory testing cycle encompasses all activities starting from a medical doctor
writing a laboratory request up to the time (called the turnaround time [TAT]) the results are
generated and become useful information for the treatment and management of patients.
This cycle has three phases, namely, pre-analytic, analytic, and post-analytic. The pre-
analytic phase includes the receipt of the laboratory request, patient preparation, specimen
collection, transport and processing of specimen to the clinical laboratory. The analytic
phase the actual testing of the submitted/collected specimen. Important consideration
should be given to equipment and instruments used, reagents, and internal quality control.
The post-analytic phase includes the transmission of test results to the medical doctor for
interpretation, TAT, and application of doctor's recommendations. The diagnosis and
treatment are based on the generated data.

            Medical technologists/clinical laboratory scientists should have a clear


understanding of this testing cycle in order to prevent erroneous test results. In the pre-
analytic phase, variables that may affect the test results are present in the preparation of the
request slip for the patient until the sample is transported to and processed in the clinical
laboratory. Some of the variables that may cause errors are physiologic factors, diet,
medications, alcohol and caffeine intake, exercise, underlying disease conditions,
identification of patients and labeling of specimens, anticoagulant used, and volume of
specimen collected vis-à-vis volume of anticoagulant. The major sources of variables under
the analytic phase are equipment and instruments, quality of reagents used, and internal
quality control program. The post-analytic phase looks into the control of the variables of
TAT and transcription errors (e.g., wrong value used, results given to the wrong patient).

Quality Assurance in the Clinical Laboratory

            Quality assurance (QA) encompasses all activities performed by laboratory personnel
to ensure reliability of test results. It is organized, systematic, well-planned, and regularly
done with the results properly documented and consistently reviewed.

            Quality assurance in the clinical laboratory has two major components: Internal
Quality Assurance System (IQAS) and External Quality Assurance System (EQAS). IQAS
includes day-to-day activities that are undertaken in order to control factors or variables
that affect test results. Regular review and audit of results are done in order to identify
weaknesses and consequently perform corrective actions. EQAS, on the other hand, is a
system checking performance among clinical laboratories and is facilitated by designated a
agencies. The National Reference Laboratories (NRL) is the DOH-designated FOA unknown
sample with known test results is regularly sent to a clinical laboratory for to Results are
then returned to the external facility and are compared with the known This procedure
determines the performance of the laboratory. A certificate of performance given to the
participating clinical laboratory.

At present, the designated NRL-EQAS are the following:

•         National Kidney and Transplant Institute (NKTI) - Hematology and Coagulation

•         Research Institute of Tropical Medicine (RITM) - Microbiology (identification and


antibiotic susceptibility testing) and Parasitology (identification of ova quantitation of
malaria)

•         Lung Center of the Philippines (LCP) - Clinical Chemistry (for testing 10 analytes
namely glucose, creatinine, total protein, albumin, blood urea nitrogen, uric acid cholesterol,
sodium, potassium, and chloride)

•         East Avenue Medical Center (EAMC) - Drugs of abuse (methamphetamine and


cannabinoids)

•         San Lazaro Hospital STD-AIDS Cooperative Center Laboratory (SACCL) - Infectious


immunology hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV),
hepatitis C virus (HCV)
 Unit 5: PROFESSIONAL ETHICS AND VALUES: MORAL IMPLICATIONS

Introduction

In the practice of medical technology, it is imperative to know how to observe, professional


ethics while interacting with colleagues, patients, and other significant members of the
healthcare team. It is difficult to distinguish what is ethical from the point of one's norms
and values and within the standard norms and values of society. Every medical technologist
is asked to perform medical research and treatment procedures within the bounds of what
is ethical, and accept the legal consequence and moral implications.

 KEY TERMS

 Bioethics: A branch of science that deals with the study of the morality of human conduct
concerning human life in all its aspects from the moment of conception to its natural end.

 Ethics: A philosophical and practical science that deals with the study of the morality of
human acts or human conduct.

Malpractice: An intentional act of professional negligence by a healthcare provider, in which


care provided deviates from accepted standards of practice in the medical community and
may cause injury or death to the patient.

Medical data breach: The intentional and unintentional disclosure of medical records
without the consent of the patient.

Medical ethics: A field of applied ethics that studies moral values and judgments as they
apply to medicine.

Morality: A system of ideas and/or beliefs on good (right) or evil (wrong).

Negligence: A general term denoting conduct lacking in due care.

Professional ethics: A branch of moral science that deals with the obligations that a member
of a profession owes to the public, the profession, and his/her clients.

Values: The beliefs that guide peoples' thoughts and Value development: It is a product of
human interaction with the cultural environment.

Learning Outcomes

At the end of this unit, students will be able to:

1.    Discuss professional ethics.

2.    Recognize and appreciate the Medical Technology ethics and values.

Medical Technology Ethics and Values

Ethical problems associated with medical practice bioscience fall within the scope of medical
technology. Ethics does not only deal with patient-physician relationships from a moral
point of view, but extends to social issues to health, animal welfare, and environmental
concerns.

Types of Ethics

General Ethics

This type of ethics presents truths about human acts, from which the general principle
of morality is deduced.

Special Ethics

This involves the application of the principles of general ethics in different departments of
human activity both at the individual and social levels. Special ethics can be further divided
into individual ethics, which are concerned with God, self, and fellow human beings; and
social ethics, which are concerned with family, the state, and the world.

Professional Ethics

Professional ethics is a branch of moral science that deals with how and what a professional
should or should not do in the workplace. It addresses the question, "What should I do in
this situation?" Professional ethics are intended to bind professions more tightly together
around a shared standard of values. A professional has obligations to his profession, to the
public, and to his or her clients. Moral issues may sometimes arise in the workplace.
Knowledge on professional ethics can guide staff in analyzing assumptions and arriving at
ethical decisions.

            A professional who observes professional ethics is exemplified by a person who


observes appropriate conduct and behavior while carrying out his work. This conduct and
behavior should be adopted in all dealings for the good of the community and humankind.

Code of Professional Ethics

            The objectives of professional ethics:

1.  Perform duties and responsibilities objectively in accordance with relevant standards and
guidelines.

2. Serve in a lawful and honest manner, while maintaining high standards of conduct and
character and not engage in acts discreditable to the profession.

3. Maintain the privacy and confidentiality of information obtained in the course of duty
unless disclosure is required by a legal authority. Such information should not be used for
personal benefit or released to inappropriate parties.

4. Perform tasks with full confidence, absolute reliability, and accuracy.

5. Be dedicated to the use of clinical laboratory science to promote life and for the benefit
of mankind.

Medical Ethics

This is a field of applied ethics that studies moral values and judgments as they apply to
medicine. Medical ethics are a set of norms, values, and principles that serve as guidelines
for medical practitioners-such as physicians, nurses, medical technologists and other
associated professionals in making decisions in clinical settings. Moral values are based on
various sources such as religion, philosophy, professional codes, professional associations,
family, culture, community, colleagues, and personal experience. Medical ethics can affect
the well-being of patients and even the medical practioner's professional and personal lives.
Medical professionals have to deal with daily ethical dilemma in clinical settings because the
community relies on critical decisions made in time, which sometimes have far-reaching
consequences.

Moral Principles in Medical Technology Ethics

Autonomy. This principle dictates that the patient has the right to refuse or choose their
treatment.

Beneficence. This principle indicates that a practitioner should act in the best interest of the
patient.

Nonmaleficence. This principle provides that evil or harm should not be inflicted either on
oneself or on others.

Justice. This principle is concerned with the distribution of scarce health resources and the
decision on who gets what treatment in terms of fairness and equality.

Respect for Dignity. This principle provides for all the necessary means of care, high regard
for the person or the patient, and needed information to make a relevant decision.

Truthfulness and Honesty. This is simply the dedication of a person to his job and is
reflective of being honest and concerned.

Stewardship. This principle refers to the expression of one's responsibility to nurture and
cultivate what has been entrusted to him.

VALUES OF A MEDICAL TECHNOLOGIST

A person's beliefs are influenced by one's family, community, society, culture, religion, and
colleagues. These factors shape one's values and behavior. The values of a person are not
constant; they change over time. Aside from the values that are inherent in an individual,
other values can also be developed. An inherent personal value motivates a person to
choose what is good for oneself, and becomes the basis for one's interest in doing what is
right. Personal values are developed from life experiences.

A child who cannot support himself/herself needs the care of the family in order to survive.
A family, which is the basic unit of a society, is governed by unconditional love and trust
that protects the interests of each family member. Because of strong family ties, family
values have strong influence on a person's belief and behavior. Similarly, the community to
which an individual belongs can also shape the cultural values of a person. It sets the
standards that are acceptable in the society which defines the way of life in the community.
American values are different from Asian values; and within Asia, Korean values are different
from Filipino values. When an individual moves to another country, an adjustment to the
cultural values of his new place is needed to get along with the citizens of that place. People
within the community belong to different religious organizations that have different faith
and spirituality. Spiritual values are based on religious values that emanate from God.
An individual is usually governed by the combination of these values. Conflict between
these values creates problem as one value contradicts another value. The conflict of values
causes confusion on the right thing to do in a particular situation.

The values of an employee are important to keep order within the workplace. A code of
conduct, which defines the expected behavior of an employee, is set within the workplace.
In a professional setting, values and ethics serve as the foundation of an organization.
Within the workplace, professionals have different values, attitudes, backgrounds and skills,
so there is a need for a common work ethic. This is important in achieving a common goal.
Some of the employee's work values are punctuality, integrity, commitment, honesty, and
loyalty.

The practice of medical technology consists of engaging in activities to conduct analysis and
tests in the field of medical biology on the human body or on a specimen, and to ensure the
technical validity of the results for diagnostic or therapeutic follow-up purposes. A medical
technologist is accountable to the patient, to the attending physician and to the community
in general. This means that the medical technologist takes on the responsibility of providing
accurate and reliable test results.

The medical technologist works collaboratively with the medical practitioner in providing
patient care through accurate diagnosis and treatment. The commitment to provide prompt
and professional service is important in efficient healthcare delivery.

Integrity in laboratory management is needed in quality assurance. The medical


technologist review records in compliance with clinical guidelines in specimen diagnostic
assay, and data collection. The obligation the confidentiality of all laboratory test results and
information is a sign of respect to the right of patient for privacy.

The Profession of Medical Technologists

Primarily, medical technologists should carry out their duties conscientiously and take
responsibility for their own actions.  A medical technologist obeys the instructions and
directions of the management. However, if it conflicts with the conviction fundamental
principles of the profession, they have the right to turn down work that affects its quality
and control. Being in the profession, they should pay attention to the risk of contagion
hygiene, and the external environment. Medical technologist should keep abreast of the
latest advancements in their field of education and continue enhancing their professional
skills.

As in other medical professions, mistakes in the practice of medical technology are


sometimes inevitable and can lead to ethical dilemmas. In this situation, the medical
technologists’ code of ethics serves as the guidelines for making the appropriate decision.
However, not all medical technologists will arrive at the same decision even though the
same ethical principles are applied. Nevertheless, a high level of integrity should be
maintained in dealing with ethical dilemmas.

Medical Technologists and Patients

Patients' rights include the right to be treated with dignity, the right to self-determination
and the right to not be harmed or hurt. People are entitled to protect their own identity and
individuality. Within the bioethical sphere, the patient has a right to participate in the
decision-making process along with professionals, especially if it pertains to the patient’s
own welfare and condition. It is, therefore, the duty of the professionals to respect the
patient's decision. At the same time, the Medical technologist should clearly inform the
patient possibilities and limitations of the treatment prescribed aim of explaining the risks in
treatment and trials is to gain cooperation from the patient consent prior to the trials.

Because of the advancements in technology, medical data breach has become a pressing


issue for the medical profession. Confidentiality in the field of medicine is about protecting
the patient's information and medical results. Negligence on the part of medical
technologists to safeguard the security of the patient record will jeopardize patient privacy.
Because of this, lack of trust in the medical field has become a growing problem in the
healthcare system.

Medical Technologists and Their Colleagues

Medical technologists should respect the work of their colleagues and support them
professionally. They must exhibit tolerance toward other professionals work methods and
circumstances. Supportive behavior promotes health and safety in the work environment.

Medical Technologists and Their Workplace

Ethics are rules and values used in a professional setting. In the workplace, managers and
supervisors set standards or ethics to show respect and honesty as well as to promote trust.
If the team uses unethical forms of communication, the organization cannot succeed. Ethics
are used worldwide in small or large companies, including hospitals. Ethics in the workplace
promotes a sense of worth and trust among professionals. Medical technologists are
expected to make their knowledge available to other medical technologists, biomedical
students, and other members of the healthcare team. They should be respectful of their
responsibility and other professional disciplines and work toward establishing and building
cooperation with other professionals. Thus, patients will benefit. The medical technologists
will also contribute toward improving public healthcare service as well the utilization of
resources. The clients trust that the services provided by the professionals will benefit them.

Medical Technologists and the Society

Medical technologist should keep themselves informed of the developments and changes in
biomedical and political healthcare legislations. They should also ensure that all biological
materials be disposed in an ethical and environmentally safe manner.

Problems and Concerns in Medical Technology Practice

Negligence

This means failure to act and use reasonable care. Anyone, including nonmedical persons,
can be liable for negligence. Negligence involves carelessness and deviation from the
expected standard of care in a particular set of circumstances.

Malpractice

This is an act of negligence or omission of a healthcare service expected from a professional


healthcare provider in which the care provided deviates from accepted standards of practice
in the medical community and may result in injury or death of the patient. Malpractice is a
more specific term that pertains to both the standard of care and professional status of the
healthcare provider. If the person committing the wrong deed is a professional, then he or
she is liable for malpractice.
In order to prove negligence or malpractice, the following elements must be established: a
duty is owed, which means that a legal duty exists whenever a hospital or healthcare
provider undertakes care or treatment of a patient; a duty was breached, which means that
the healthcare provider failed to conform to the relevant standard of care; the breach causes
an injury, which means that the breach of duty was the proximate cause of injury; and
damages that may be economic (lost earning capacity, medical expenses, and so on) and
noneconomic damages, including physical damage such as loss of vision, organ, and Limbs
and psychological damage such as severe pain and emotional distress.

 Unit 6: MEDICAL TERMINOLOGIES AND ABBREVIATIONS

Introduction

Most medical terms are derived from Greek and Latin words. Since clinical laboratory
personnel are in constant communication with other health care personnel, patients, and
family members on a daily basis, they need to be familiar with the abbreviations and
meanings of common medical terms. This unit includes some of  the common medical
terminologies and their meaning,

Also included are the rules on the appropriate letter that comes after a suffix, how to
convert a medical term from its singular form to its plural form.

Learning Outcomes

  At the end of this unit, students will be able to:

1.      Identify the meaning of the root word,  prefixes and suffixes commonly used in
medical 

         terminologies;

2.      Use correctly commonly used  prefixes and suffixes;

3.      Define meaning of common medical terms used in the practice of medical technology.

Presentation of Contents

A medical term has three basic parts-the root word, the prefix, and the suffix. The root word
is the main part of the medical term that denotes the meaning of the word.

Examples:       colo - colon

 hemat – blood

              phlebo - vein

   aero - air

            The prefix is found at the beginning of the term and it shows how meaning is
assigned to the word.

Examples:

a-/an--without, absence
 hyper-- meaning increased/above

 poly-- many pre—before

            On the other hand, the suffix is found at the terminal portion or at the end of the
term. It also denotes the meaning to the root word.

Examples:        -megaly - enlargement

  -emia -blood

   -uria - urine 

   -ostomy - to make an opening or mouth

            It is a rule that if the suffix starts with a consonant, a combining vowel needs to be
used (usually the letter O). The combining vowel does not change the meaning of the root
word and is added in order to make the pronunciation of the word easier. The combining
vowel is added between the root word and the suffix. Examples:

hemat + logy = hematology - study of blood

phlebo + tomy - phlebotomy - the process of cutting into the vein using a needle.

  The plural form of medical terms is made by changing the end of the word and not
by simply adding S, which follows the rule for irregular nouns.

Examples:

bacterium bacteria

nucleus nuclei

thrombus thrombi

bacillus bacilli

Root Words

cardio = heart myo = muscle arterio = arterys cyto = cell

arthro = joint

heap/hepato = liver pyo = pus cranio = skull

pyro = fever  nephro = kidney

osteo = bone

Prefixes

iso- = same micro- = small macro- = large intra- = inside/within


pseudo- = false

anaero- = without oxygen mono- = one

homo- = same, like nano- = billionth

cryo- = cold hypo- = decreased logamning neo-= new

Suffixes

-itis = inflammation of -megaly = enlargement -blast = young -cidal = killing of

-poiesis = formation

pathy = disease -meter = measure  -penia = deficiency -ectomy = surgical removal oma =
tumor

 -emia = blood condition to -tome = cutting instrument

Abbreviations

Listed below are the commonly encountered abbreviations in the health care practice that
medical technology students should know:

DOH - Department of Health

CHED - Commission on Higher Education 

VDRL - Venereal Disease Research Laboratories

AIDS - Acquired Immunodeficiency Syndrome

AIDs - Autoimmune disorders/diseases

AMI - Acute Myocardial Infarction

BUN - Blood Urea Nitrogen

2PPBS - 2 hours Postprandial Blood Sugar

AFS - Acid Fast Stain

PCQACL - Philippine Council for Quality Assurance in the Clinical Laboratories

FBS - Fasting Blood Sugar

IV - Intravenous

HIV - Human Immunodeficiency Virus

IU - International Unit

ICU - Intensive Care Unit

K - Potassium
Na - Sodium

NPO- Nothing Per Orem

BAP - Blood Agar Plate

 Unit 7: LABORATORY BIOSAFETY AND BIOSECURITY

Good biosafety, laboratory biosecurity and biocontainment practices are fundamental to


public health. Perhaps the failure to follow appropriate biosafety and laboratory biosecurity
practices may still be the greatest threat for the reappearance of SARS. Likewise, biosafety,
laboratory biosecurity and biocontainment practices are crucial for the safekeeping of
poliovirus within laboratories as laboratories and culture collections become the only
repositories of the wild poliovirus. The continuing implementation of appropriate biosafety,
laboratory biosecurity and biocontainment practices is essential to prevent the release of
variola viruses from the two custodial repositories (CDC, Atlanta, GA, USA, and VECTOR,
Koltsovo, Novosibirsk Region, Russian Federation), where research on these viruses is
carried out.

Responsible laboratory practices, including protection, control and accountability for


valuable biological materials will help prevent their unauthorized access, loss, theft, misuse,
diversion or intentional release, and contribute to preserving scientifically important work
for future generations.

Learning Outcomes

At the end of this unit, students will be able to:

  1.      Discuss the history and the related policies and guidelines governing laboratory
biosafety and biosecurity.

2.      Classify microorganisms according to risk group.

3.      Categorize laboratories according to biosafety level.

Presentation of Contents

 Brief History of Laboratory Biosafety

             Observing and implementing laboratory safety precautions are of utmost


importance in the medical technology practice. Individuals who handle and process
microbiological specimen are vulnerable to pathogenic microorganisms which are possible
sources of laboratory acquired infections (LAI).

            Laboratory biosafety and biosecurity traces its history in North America and Western
Europe. The origins of biosafety is rooted in the US biological weapons program which
began in 1943, as ordered by then US President Franklin Roosevelt and was active during
the Cold War. It was eventually terminated by US President Richard Nixon in 1969. In 1943,
Ira L. Baldwin became the first scientific director of Camp Detrick (which eventually became
Fort Detrick), and was tasked with establishing the biological weapons program for
defensive purposes to enable the United States to respond if attacked by such weapons.
After the Second World War, Camp Detrick was designated a permanent installation for
biological research and development. Biosafety was an inherent component of biological
weapons development. Later on, Newell A. Johnson designed modifications for biosafety at
Camp Derrick. He engaged some of Camp Detrick's leading scientists about the nature of
their work, and developed specific technical solutions such as Class III safety cabinets and
laminar flow hoods to address specific risks. Consequent meetings eventually led to the
formation of the American Biological Safety Association (ABSA) in 1984. The association
held annual meetings that soon became the ABSA annual conferences (Salerno et al., 2015).

            Other contributors outside the United States included Arnold Wedum who described
the use of mechanical pipettors to prevent laboratory-acquired infections in 1907 and 1908
(Kruse (1991), cited by Salerno, 2015). Moreover, ventilated cabinets, early progenitors to
the nearly ubiquitous engineered control now known as the biological safety cabinet, were
also first documented outside of the US biological weapons program. In 1909, a
pharmaceutical company in Pennsylvania developed a ventilated cabinet to prevent
infection from mycobacterium tuberculosis.

            At the height of increasing mortality and morbidity due to smallpox in 1967, WHO
aggressively pursued the eradication of the virus (College of Physicians of Philadelphia
2014). It was also during this time that serious concerns about biosafety practices worldwide
were raised, contributing directly to the decision of the World Health Assembly to
consolidate the remaining virus stocks into two locations: the Center for Disease Control
and Prevention (CDC) in the United States and the State Research Center of Virology and
Biotechnology VECTOR (SRCVB VECTOR) in Russia. In 1974, the CDC published the
Classification of Etiological Agents on the Basis of Hazard, that introduced the concept of
establishing ascending levels of containment associated with risks in handling groups of
infectious microorganisms that present similar characteristics. Two years later, the National
Institutes of Health (NIH) of the United States published the NIH Guidelines for Research
Involving Recombinant DNA Molecules. It explained in detail the microbiological practices,
equipment, and facility necessarily corresponding to four ascending levels of physical
containment.

            These guidelines laid the foundation for the introduction of a code of biosafety
practice. The code, along with WHO's first edition of Laboratory Biosafety Manual (1983)
and the NIH's jointly-published first edition of the Biosafety in Microbiological and
Biomedical Laboratories (1984), marked the development of the practice of laboratory
biosafety These documents established the model of biosafety containment levels with
certain agents which increased the biosafety levels for biological agents that pose risks to
human health. Bi levels are the technical means of mitigating the risk of accidental infection
from or of agents in the laboratory setting as well as the community and environment it is
sit in. Although biosafety levels are concentrated in a combination of engineered con
administrative controls, and practices, the emphasis is clearly on the equipment and facility
controls, with little attention given to risk assessment.

            This progress in biosafety practice continued until the emergence of a community of
"biosafety officers" who adopted the administrative role of ensuring that the proper
equipment and facility controls are in place based on the specified biosafety level of the
laboratory.

            Arnold Wedum, director of Industrial Health and Safety at the US Army Biological
Research Laboratories in 1944, was recognized as one of the pioneers of biosafety that
provided the foundation for evaluating the risks of handling infectious microorganisms and
for recognizing biological hazards and developing practices, equipment, and facility
safeguards for their control. In 1966, Wedum and microbiologist Morton Reitman,
colleagues at Fort Detrick, analyzed multiple epidemiological studies of laboratory-based
outbreaks.

Brief History of Laboratory Biosecurity

            In 1996, the US government enacted the Select Agent Regulations to monitor the
transfer of a select list of biological agents from one facility to another. Slightly after the
terrorist attacks and the anthrax attacks of 2001, also known as Amerithrax, the US
government changed its perspective. The revised Select Agent Regulations then required
specific security measures for any facility in the United States that used or stored one or
more agents on the new, longer list of agents.

            The revision of the Select Agent Regulations in 2012 sought to address the creation
of two tiers of select agents. Tier 1 agents are materials that pose the greatest risk of
deliberate misuse, and the remaining select agents. This change was intended to make the
regulations more risk-based, mandating additional security measures for Tier 1 agents.
Other countries also relatively implemented and prescribed biosecurity regulations for
bioscience facilities. Singapore's Biological Agents and Toxins Act is similar in scope with the
US regulations but with more severe penalties for noncompliance (Republic of Singapore
2005). In South Korea, the Act on Prevention of Infectious Diseases in 2005 was amended to
require institutions that work with listed "highly dangerous pathogens” to implement
laboratory biosafety and biosecurity requirements to prevent the loss, theft, diversion,
release, or misuse of these agents. In Japan, the Infectious Disease Control Law was recently
amended under Japan's Ministry of Health, Labor, and Welfare. It also established four
schedules of select agents that are subject to different reporting and handling requirements
for possession, transport, and other activities.  Then in Canada, Canadian containment level
(CL) 3 and CL4 facilities  that work with risk group 3 or 4 are required to undergo
certification. In 2008, the Danish Parliament passed a law that gives the Minister of Health
and Prevention the authority to regulate the possession, manufacture, use, storage, sale,
purchase or other transfer, distribution, transport, and disposal of listed biological agents.
Around the world, biosecurity implementation has become a purely administrative activity
based on a government developed checklist.

Local and International Guidelines on Laboratory Biosafety and Biosecurity

            In February 2008, the Comité Européen de Normalisation (CEN), a European


Committee for Standardization published the CEN Workshop Agreement 15793 (CWA
15793) which focuses on laboratory biorisk management. The Workshop offers a
mechanism where stakeholders can develop consensus standards and requirements in an
open process. The CW 15793 can be applied to international stakeholders, however, they do
not have the force of regulation while conformity is voluntary. The CWA 15793 was
developed among experts from 24 different countries including Argentina, Australia,
Belgium, Canada, China, Denmark, Germany, Ghana, UK, US, among others. It was updated
in 2011 and intended to maintain a biorisk management system among diverse
organizations and set out performance-based requirements with the exclusion of guidance
for implementing a national biosafety system. Since it originated in the European workshop
agreement framework, confusion among countries outside Europe arose especially in the
United States in terms of its applicability. Nevertheless, the agreement was used until it
officially expired in 2014 (Gronvall, 2015).
            To address concerns on biosafety guidance for research and health laboratories,
issues on risk assessment and guidance to commission and certify laboratories, the WHO in
1983 published its 3rd edition of the Laboratory Biosafety Manual. It includes information
on the different levels of containment laboratories (Biosafety levels 1-4), different types of
biological safety cabinets, good microbiological techniques, and how to disinfect and
sterilize equipment. In terms of biosecurity, it covers the packaging required by international
transport regulations and other types of safety procedures for chemical, electrical, ionizing
radiation, and fire hazards. The manual puts emphasis on the continuous monitoring and
improvement directed by a biosafety officer and the biosafety committee. Unfortunately,
there is no mechanism to ensure that the WHO biosafety guidance is being adhered to, or
that people working in laboratories are sufficiently trained.

            The Cartagena Protocol on Biosafety (CPB), made effective in 2003 which applies to
the 168 member-countries provides an international regulatory framework to ensure "an
adequate level of protection in the field of safe transfer, handling, and use of living modified
organisms (LMOs) resulting from modern biotechnology." The regulations primarily tackle
the safe transfer, handling, and use of LMOs that may have adverse effects on the
conservation of biological diversity except those that are used for pharmaceuticals
purposes. In addition legislation provides a framework for assessing the risk of LMOs and is
focused on that LMOs do not negatively affect biodiversity.

            The new National Committee on Biosafety of the Philippines (NCBP) established E.O.
430 series of 1990 was formed on the advocacy efforts of scientists. The man NCPB focuses
on the organizational structure for biosafety: procedures for evaluating proposals with
biosafety concerns; procedures and guidelines on the introduction, move and field release
of regulated materials, and procedures on physico-chemical and biological containment. On
March 17, 2006, the Office of the President promulgated E.O establishing the National
Biosafety Framework (NBF), which prescribes the guidelines for implementation,
strengthening the National Committee on Biosafety of the Philippines NBF is a combination
of policy, legal, administrative, and technical instruments developed attain the objective of
the Cartagena Protocol on Biosafety which the Philippines signed on May 24, 2000. The NBF
can be considered as an expansion of the NCBP, which since 1989 has played an important
role in pioneering the establishment and development of the current biosafety system of
the country and was acknowledged as a model system for developing countries. The
Department of Agriculture (DA) also issued Administrative Order No. 8 t set in place policies
on the importation and release of plants and plant products derived from modern
biotechnology. The Department of Health (DOH), together with NCBP, formulated
guidelines in the assessment of the impacts on health posed by modern biotechnology and
its applications. The guidelines aid in evaluating and monitoring processed food derived
from or containing GMO. Currently, DOH, in the midst of technological advances, recognizes
the need to update the minimum standards and technical requirements for clinical
laboratories. It requires clinical laboratories to ensure policy guidelines on laboratory
biosafety and biosecurity (DOH Administrative Order No. 2007-0027).

Different Organizations in the field of Biosafety

            Several organizations across continents have undertaken initiatives in advocating for
laboratory biosafety and biosecurity. The following are some prominent organizations inside
and outside the Philippines:

1.      American Biological Safety Association (ABSA) a regional professional society for


biosafety and biosecurity founded in 1984. It promotes biosafety as a scientific O discipline
and provides guidance to its members on the regulatory regime present in North America.
2.      Asia-Pacific Biosafety Association (A-PBA) a group founded in 2005 that acts as a
professional society for biosafety professionals in the Asia-Pacific region. Its members E are
from Singapore, Brunei, China, Indonesia, Malaysia, Thailand, the Philippines, and Myanmar.
Active members of the International Biosafety Working Group are be required to directly
contribute to the development of the best biosafety practices.

3.      European Biological Safety Association (EBSA) a non-profit organization to in June


1996, that aims to provide a forum for discussions and debates on issue sent those working
in the field of biosafety. EBSA focuses on encouraging and communicating among its
member’s information and issues biosafety and biosecurity as well as emerging legislation
and standards.

4.      Philippine Biosafety and Biosecurity Association (PhBBA) created by a multi-disciplinary


team with members coming from the health and education sector's as well as individuals
from the executive, legislative, and judicial branches of government. Also included are
members of the steering committee and technical working groups of the National
Laboratory Biosafety and Biosecurity Action Task Force established as per DPO No. 2006-
2500 dated September 15, 2006. A long term goal of the association is to assist the DA and
DOH in their efforts to create a national policy and implement plan for laboratory biosafety
and biosecurity.

5.      Biological Risk Association Philippines (BRAP) a non-government and non-profit


association that works to serve the emergent concerns of biological risk management in
various professional fields such as in the health, agriculture, and technology sectors
throughout the country. It has launched numerous activities in cooperation and
collaboration with other associations, on a national and international scale in the promotion
of biosafety, biosecurity, admittance to authorized personnel only and biorisk management
as scientific disciplines. BRAP goes by the tagline, "assess, mitigate, monitor."

            Currently, member countries of ABSA, A-PBA, and EBSA have founded organizations
in their respective nations which share the same goals and objectives in addressing issues
and concerns related to biosafety and sign for laboratory doors biosecurity.

Fundamental Concepts of Laboratory Biosafety and Biosecurity

            WHO issued a common understanding of biosafety derived from the practical
guidance on techniques to be used in laboratories. Biosafety has long been practiced in
most nations especially among institutions that handle and process microbiological
specimen. The WHO Laboratory Biosafety Manual (LBM) defines biosafety as "the
containment principles, technologies, and practices that are implemented to prevent
unintentional exposure to pathogens and toxins, or their accidental release." On the other
hand, biosecurity refers to "the protection, control, and accountability for valuable biological
materials laboratories, in order to prevent their unauthorized access, loss, theft, misuse,
diversion or intentional release" (WHO, 2006). By simple definition, "biosafety protects
people for germs" while "biosecurity protects germs from people."

            In 1966, Charles Baldwin, an environmental health engineer working for the Dow
Chemical Company containment systems products, created the biohazard symbol used
labeling biological materials carrying significant health risks.

            Biosafety and biosecurity share common perspectives in terms of risk assessment
and management methodologies, personnel expertise and responsibility, control and
accountability for research materials including microorganisms and culture stocks, access
control elements, material transfer documentation, training, emergency planning, and
program management among others.

            To sum up, biosafety focuses on laboratory procedures and practices necessary to
prevent exposure to and acquisition of infections while the maintenance of secure
procedures and practices in handling biological materials and sensitive information falls
under biosecurity.

Classifications of Microorganisms According to Risk Groups

            WHO recommends an agent risk group classification for laboratory use that
describes four general risk groups based on principal characteristics and relative hazards
posed by infectious toxins or agents. Risk group classification for humans and animals is
based on the agent's pathogenicity, mode of transmission, host range, and the availability
of preventative measures and effective treatment. Through the classification, infective
microorganisms are classified as Risk Group 1, Risk Group 2, Risk Group 3, and Risk Group 4:

1.      Risk group 1 - includes microorganisms that are unlikely to cause human or animal
disease. These microorganisms bring about low individual and community risk.

2.       Risk group 2 - includes microorganisms that are unlikely to be a significant risk to


laboratory workers and the community, livestock, or the environment. Laboratory exposure
may cause infection, however, effective treatment and preventive measures are available
while the risk of spread is limited. This risk group bring about moderate individual risk and
limited community risk.

3.       Risk group 3 - includes microorganisms that are known to cause serious diseases to
humans or animals and may present a significant risk to laboratory workers. It could present
a limited to moderate risk if these microorganisms spread in the community or the
environment, but there are usually effective preventive measures or treatment available.
They bring about high individual risk, and limited to moderate community risk.

4.       Risk group 4 - includes microorganisms that are known to produce life-threatening


diseases to humans or animals. It represents a significant risk to laboratory workers and may
be readily transmissible from one individual to another while effective treatment and
preventive measures are not usually available. In effect, they bring about high individual and
community risk.

Categories of Laboratory Biosafety According to Levels

            In order to facilitate precautionary measures, CDC categorized laboratories into four
biosafety levels-Biosafety Level 1, Biosafety Level 2, Biosafety Level 3, and Biosafety Level 4.
Biosafety level designations are based on a composite of the design features, construction,
containment facilities, equipment, practices, and operational procedures required for
working with agents from the various risk groups. They are designated in ascending order,
by degree of protection provided to the personnel, the environment, and the community
(BMBL, 5th edition).

1.      Biosafety Level 1 (BSL-1) is suitable for work involving viable microorganisms that are
defined and with well-characterized strains known not to cause disease in humans.
Examples of microorganisms being handled in this level are Bacillus subtilis, Naegleria
gruberi, infectious canine hepatitis virus, and exempt organisms under the NIH Guidelines.
This level is the most appropriate among undergraduate and secondary educational training
and teaching laboratories that require basic laboratory safety practices, safety equipment,
and facility design that requires basic level of containment.

2.       Biosafety Level 2 (BSL-2) is basically designed for laboratories that deal with
indigenous moderate-risk agents present in the community. It observes practices,
equipment, and facility design that are applicable to clinical, diagnostic, and teaching
laboratories consequently observing good microbiological techniques. Examples of
microorganisms that could be handled under this level are Hepatitis B virus, HIV,
salmonellae, and Toxoplasma species. BSL-2 is appropriate when work is done with human
blood, body fluids, tissues, or primary human cell lines where there is uncertain presence of
infectious agents. Hand washing sinks and waste decontamination facilities must be
available and access to the laboratory must be restricted when work is being conducted. All
procedures where infectious aerosols or splashes may be created are conducted in biosafety
cabinets or other physical containment equipment.

3.       Biosafety Level 3 (BSL-3) puts emphasis on primary and secondary barriers in the
protection of the personnel, the community, and the environment from infectious aerosol
exposure. Work with indigenous or exotic agents with a potential for respiratory
transmission, and that may cause serious and potentially lethal infection are being
conducted here. Examples of microorganisms handled here are Mycobacterium
tuberculosis, St. Louis encephalitis virus, and Coxiella. All laboratory activities are required to
be performed in a biosafety cabinet or other containment equipment like a gas-tight
aerosol generation chamber. Secondary barriers for this level are highly required including
controlled access to the laboratory and vent requirements to minimize the release of
infectious aerosols from the laboratory while special engineering and design features are
being considered. Personnel must be supervised by scientists competent in handling
infectious agents and associated procedures in a BSL-3 laboratory.

4.       Biosafety Level 4 (BSL-4) is required for work with dangerous and exotic agent that
pose high individual risks of life-threatening diseases that may be transmit via the aerosol
route, for which there are no available vaccines or treatment. Specific practices, safety
equipment, and appropriate facility design and construction are required for instance when
manipulating viruses such as the Marburg or the Crimean-Congo hemorrhagic fever and
any other agents known to pose a high riel of exposure and infection to laboratory
personnel, community, and environment The laboratory worker's complete isolation from
aerosolized infectious material is accomplished primarily by working in a Class III biosafety
cabinet or in a full. Body, air-supplied positive-pressure personnel suit. A BSL-4 laboratory is
generally a separate building or completely isolated zone with specialized ventilation
requirements and waste management systems. Laboratory staff must have specific and
thorough training in handling extremely hazardous infectious agents. The laboratory is
controlled by the laboratory supervisor in accordance with institutional policies.
 

 Unit 8: BIORISK MANAGEMENT

In working with infectious agents and toxins in laboratories, one must consider the practices
and procedures on biocontainment to ensure biosafety and biosecurity. Proper
management is necessary to carry out total safety of laboratory workers and patients.

 Biorisk is the risk associated to biological toxins or infectious agents. The source of risk
may be unintentional exposure to unauthorized access, accidental release or loss, theft,
misuse, diversion, or intentional unauthorized release of biohazards. Biorisk management is
the integration of biosafety and biosecurity to manage risks when working with biological
toxins and infectious agents (CWA 15793 Laboratory Biorisk Management Standard).

 According to the CEN Workshop Agreement (CWA) 15793:2011, Biorisk Management


(BRM) is “a system or process to control safety and security risks associated with the
handling or storage and disposal of biological agents and toxins in laboratories and
facilities.” BRM encompasses the identification, understanding, and management aspects of
a system in interrelated processes. It is divided into three primary components: assessment
(A), mitigation (M), and performance (P). These components are collectively captured by
what is called the AMP model (World Health Organization, 2010). The model requires that
control measures be based on a robust risk assessment, and a continuous evaluation of
effectiveness and suitability of the control measures. Identified risks can be either mitigated,
avoided, limited, transferred to an outside entity, or accepted.

Like a three-legged stool, a biorisk management system fails if one of the components, or
legs, is overlooked or is not addressed. In contrast to other risk management models, which
typically focus heavily on mitigation measures, AMP focuses on all components with equal
attention.

 Learning Outcomes

  At the end of this unit, students will be able to:

  1.       Explain the importance of  biorisk management.


2.       Discuss the AMP model.

3.       Explain the procedures on Risk Assessment.

4.       Enumerate the different mitigation procedures.

5.       Discuss the procedures on performance evaluation.

Presentation of Contents

Biorisk Management and the AMP Models

Key Components of Biorisk Management

Risk Assessment

            The initial step in implementing a biorisk management process relies on risk
assessment which includes the identification of hazards and characterization of risks that
are possibly present in the laboratory. Hazard refers to anything in the environment that
has the potential to cause harm while risk is generally defined as the possibility that
something bad unpleasant (such as an injury or loss) will happen. In order for a risk to occur,
there must be situation for the hazard to cause harm (ISO/IEC Guide 51:1999). For example,
a sharp needle is a hazard, but if no one is using it, the needle will not pose any risks. More
specifically, risk is the likelihood that an adverse event involving a specific hazard or threat
will occur followed by the consequences of that occurrence. In performing risk assessment,
a structured and repeatable process is followed. It consists of the following steps:

1.      Define the situation - the risk assessment team must identify the hazards and risks of
the biological agents to be handled. Next, at-risk hosts, who could be humans or animals
inside and outside the laboratory, must be identified. The work activities and laboratory
environment including location, procedures, and equipment should also be defined.

2.       Define the risks - defining the risks must include a review of how individuals inside
and outside the laboratory may be exposed to the hazards. It could either be through
droplets, inhalation, ingestion, or inoculation in case a biological agent has been identified
as the hazard.

3.      Characterize the risks - to characterize the overall biosafety risks, the risk assessment
team needs to compare the likelihood and the consequences of infection-either
qualitatively or quantitatively.

4.       Determine if risks are acceptable or not - this process of evaluating the


biorisk arising from a biohazard takes into account the adequacy of any existing controls,
and deciding whether or not the biorisk is acceptable.

Mitigation Procedures

            The second fundamental component of the biorisk management model


is mitigation. Biorisk mitigation measures are actions and control measures that are put
into place to read or eliminate the risks associated with biological agents and toxins
(Salerno, 2015). There a five major areas of control or measures that can be employed in
mitigating the risks.

            Elimination, the most difficult and most effective control measure, involves the total
decision not to work with a specific biological agent or even not doing the intended work.
Definitely, elimination provides the highest degree of risk reduction. Substitution, the
second control measure, is the replacement of the procedures or biological agent with a
similar entry order to reduce the risks. For example, a laboratory conducting research with
the pathogen Bacillus anthracis, responsible for causing the acute fatal disease anthrax,
could potentially substitute a less dangerous experimental surrogate, such as the Bacillus
thuringiensis, an organism most commonly used in biological pesticides worldwide. The
third control measure, setting of engineering controls, includes physical changes in work
stations, equipment, production facilities, or any other relevant aspect of the work
environment that can reduce or prevent exposure to hazards. Examples are installation of
biosafety cabinets, safety equipment (centrifuge with cover, autoclave, and machines with
indicators), and facility design enabling proper airflow, and ventilation system to ensure
directional airflow, and air treatment systems to decontaminate or remove agents from
exhaust air, controlled access zones, airlocks as laboratory entrances, or separate buildings
or modules to isolate the laboratory. The fourth measure, the setting of administrative
controls, refers to the policies, standards, and guidelines used to control risks. Proficiency
and competency training for laboratory staff is considered an administrative control. The
displaying of biohazard or warning signages, markings, and labels, controlling visitor and
worker access, and documenting written standard operating procedures are some examples.
Practices and procedures of administrative controls comprise minimizing splashes, sprays,
and aerosols to avoid laboratory-acquired infections or following standard operating
procedures (SOPs). The last mitigation control measure is the use of personal protective
equipment (PPE). These are devices worn by workers to protect them against chemicals,
toxins, and pathogenic hazards in the laboratory.

            Gloves and respirators are all examples of PPE. PPE is considered measure because it
only protects the person who is wearing it, and only when it is used correctly.

            As emphasized by Salerno (2015), not one of the mitigation controls completely
effective at controlling or reducing all risks. The effectivity of mitigating of mitigating risks
relies on the combination of all the different measures and the proper utilization of each: be
ensured that following the measures would not be overdone because undoing particular
measures are definitely costly. The concept of a hierarchy of controls describes the order of
effectiveness (from most effective to least effective) of mitigation measures and implies that
this order should be taken into account when selecting and implementing controls to
reduce risks.

Performance Evaluation

            The last pillar of the biorisk management model is performance evaluation that
involves a systematic process intended to achieve organizational objectives and goals. The
model ensures that the implemented mitigation measures are indeed reducing or
eliminating miles to also help to highlight biorisk strategies that are not working effectively
and measures the ineffective or unnecessary. These can be eliminated or replaced.
Performance management is simply a reevaluation of the overall mitigation strategy. The
diagram below shows the procedures in conducting performance evaluation.

            The result of a robust risk assessment must be properly recorded, documented, and
communicated to all stakeholders of the organization. Only through this final process that
findings could be decided upon, given appropriate action, to be able to provide and
establish a clear manifestation of implementing the fundamental concept of biosafety and
biosecurity in the laboratory.

 Unit 9: HEALTH CARE WASTE


The disposal of wastes generated by health care facilities has become a growing concern in
the country and around the world. In 2015, a joint WHO/UNICEF assessment found that just
over half (58%) of sampled facilities from 24 countries had adequate systems in place for the
safe disposal of health care wastes. This issue is given special attention as the wastes
generated by the health care industry may be hazardous to nature and are detrimental to a
person's health and to the environment. As such, all health care facilities are tasked to
ensure that there are no adverse health effects and environmental consequences resulting
from their generation, segregation, collection, storage, transport, treatment, and disposal of
health care wastes.

Learning Outcomes

At the end of this unit, students will be able to:

1.    Discuss the importance of proper waste management in healthcare facilities.

2.    Discuss the proper identification, segregation, collection, storage, transport, treatment


and disposal of healthcare wastes.

Presentation of Contents

Defining Health Care Wastes

Health care wastes refer to all solid or liquid wastes generated by any of the following
activities:

1. diagnosis, treatment, and immunization of humans; 

2. research pertaining to diagnosis, treatment, and immunization of humans; 

3. research using laboratory animals geared towards improvement of human health; 

4. production and testing of biological products; and 

5. other activities performed by a health care facility that generates wastes.

According to WHO, between 75 and 90 percent of wastes generated by health care activities
on average are non-hazardous. The remaining 10 to 25 percent is considered hazardous and
may be infectious, toxic, or radioactive. High-income countries typically generating larger
volumes of health care wastes produce 0.5 kg of hazardous waste per hospital bed per day
while low-income countries generate 0.2 kg on average. However, proper segregation of
hazardous and non-hazardous wastes in low-income countries tends to be less
implemented, thus making the real quantity of hazardous wastes much higher. In the
Philippines, 30.37 percent of wastes from health care facilities are hazardous while the
remaining 69.63 percent are general wastes. Philippine hospitals generate an average of
0.34 kg of infectious sharps and pathological wastes and 0.39 kg of general wastes per bed
per day.

All health care facilities, institutions, business establishments, and other spaces where health
care services are offered with activities or work processes that generate health care wastes
are called health care waste generators. These include

1. hospitals and medical centers 

2. infirmaries 
3. birthing homes 

4. clinics and other health-related facilities

a. Medical

b. ambulatory 

c. dialysis

d. health care centers and dispensaries

e. surgical 

f. alternative medicine

g. dental 

h . veterinary

5. laboratories and research centers

a. medical and biomedical laboratories 

b. medical research centers

 c. blood banks and blood collection services

d. dental prosthetic laboratories 

e. nuclear medicine laboratories 

f. biotechnology laboratories 

g. animal research and testing 

h. drug testing laboratories

i. HIV testing laboratories 

6. drug manufacturers 

7. institutions

a. drug rehabilitation centers

b. training centers for embalmers. 

c. medical technology internship training centers

d. schools of Radiologic Technology

e. medical schools

f. nursing homes
g. dental schools

Categories of Health Care Wastes

Health care wastes generated by health care facilities are categorized into seven: infectious
waste, pathological and anatomical waste, sharps, chemical waste, pharmaceutical waste,
radioactive waste, and non-hazardous or general waste.

1. Infectious Waste refers to all wastes suspected to contain pathogens or toxins in


sufficient concentration that may cause disease to a susceptible host. It includes discarded
materials or equipment used for diagnosis, treatment, and management of patients with
infectious diseases. Examples include discarded microbial cultures, solid wastes with
infections such as dressings, sputum cups, urine containers, and blood bags, liquid wastes
with infections such as blood, urine, vomitus, and other body secretions, and food wastes
(liquid or solid) coming from patients with highly infectious diseases. 

2. Pathological and Anatomical Waste refers to tissue sections and body fluids or organs
derived from biopsies, autopsies, or surgical procedures sent to the laboratory for
examination. Examples include internal organs and tissues used for histopathological
examinations. Anatomical waste is a subgroup of pathological waste that refers to
recognizable body parts usually from amputation procedures. 

3. Sharps refer to waste items that can cause cuts, pricks, or puncture wounds. They are
considered the most dangerous health care waste because of their potential to cause both
injury and infection. Examples include used syringes in phlebotomy, blood lancets, surgical
knives, and broken glasswares. 

4. Chemical Waste refers to discarded chemicals (solid, liquid, or gaseous) generated


during disinfection and sterilization procedures. It also includes wastes with high content of
heavy metals and their derivatives. Common examples of this type of waste are laboratory
reagents, X-ray film developing solutions, disinfectants and soaking solutions, used
batteries, concentrated ammonia solutions, concentrated hydrogen peroxide, chlorine, and
mercury from broken thermometers and sphygmomanometers. Chemicals are considered
hazardous when they are:

 toxic (with health and environment hazards)


 corrosive (acid of pH<2.0 and bases of pH>12.0)  
 flammable (with a flash point below 60 °C) 
 reactive (explosive with water)

5. Pharmaceutical Waste refers to expired, spilt, and contaminated pharmaceutical


products, drugs, and vaccines including discarded items used in handling pharmaceuticals. It
includes antineoplastic, cytotoxic, and genotoxic wastes such as drugs used in oncology or
radiotherapy, and biological fluids from patients treated with the said drugs. Examples
include empty drug vials, medicine bottles, and containers of cytotoxic drugs including
materials used for their preparation and administration such as syringes, needles, and vials.

6. Radioactive Waste refers to wastes exposed to radionuclides including radioactive


diagnostic materials or radiotherapeutic materials. Residues from shipment of radioactive
materials and unwanted solutions of radionuclides intended for diagnostic or therapeutic
use are examples of radioactive wastes as well as liquids, gases, and solids contaminated
with radionuclides whose ionizing radiations have genotoxic effects. In the hospital, usual
examples of radioactive wastes include cobalt (Co 90), technetium (99 Tc), iodine (131 I) and
iridium (192 Ir), irradiated blood products and contaminated waste, patient's excretion, and
all materials used by patients exposed to radionuclides within 4-8 hours. 

7. Non-hazardous or General Waste refers to wastes that have not been in contact with
communicable or infectious agents, hazardous chemicals, or radioactive substances, and do
not pose a hazard. Examples include plastic bottles, used paper products, office wastes,
scrap wood, and food waste of non-infectious patients. This type of waste can be further
classified as a. 

A. Recyclable wastes in health care facilities such as

·         paper products such as used office paper, computer printouts, and corrugated
cardboard boxes 

·         aluminum from beverage cans and other aluminum containers 

·         pressurized gas containers such as oxygen tanks

·         plastic products including polyethylene terephthalate (PET) plastic water bottles,


plastic milk containers, and polypropylene plastic bottles for saline solutions and irrigation
fluids 

·         glass such as used vials for sterile solutions 

·         wood such as scrap wood and used wood shipping pallets

 durable goods such as used furniture and furnishings


 electronic devices such as used computer equipment and print cartridges

b. Biodegradable health care wastes such as left-over food from non-infectious patients and
garden wastes such as grass trimmings and tree cuttings 

c. Non-recyclable/non-biodegradable health care wastes that cannot be classified into


either of the first two categories

Impact of Health Care Wastes

Individuals exposed to health care wastes such as the medical staff (doctors, nurses, medical
technologists, etc.), in- and out-patients, visitors, caregivers, support staff, waste haulers,
garbage pickers, and the general public are potentially at risk of being injured or infected.
Other potential hazards may include drug-resistant microorganisms that can spread from
health facilities into the environment. Exposure of the general population can be mainly
through chronic exposure (for prolonged periods in minute quantities) or acute exposure
(for short periods in large quantities).

Adverse health outcomes associated with health care wastes and by-products also include

 sharps-inflicted injuries 
 toxic exposure to pharmaceutical products, in particular, antibiotics and
cytotoxic drugs released into the surrounding environment, and to substances
such as mercury or dioxins, during the handling or incineration of health care
wastes 
 chemical burns from disinfection, sterilization, or waste treatment activities 
 air pollution arising as a result of the release of particulate matter during
medical waste incineration 
 thermal injuries occurring in conjunction with open burning and the operation
of medical waste incinerators 
 radiation burns

Treatment and disposal of health care wastes may pose health risks indirectly through the
release of pathogens and toxic pollutants into the environment. Following are some
guidelines in the treatment and disposal of health care wastes

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

The following are the benefits achieved through proper and strict compliance with
standards on the management of health care wastes:

 protection of patients, health workers, and the general population from the
adverse effects of health care wastes to human health;
 contribution to the collaborative efforts around the world to protect the
environment from pollution and contamination caused by health care wastes; 
 increased compliance of health care institutions to the laws, regulations, and 
guidelines on health care wastes; and 
 prevention of long-term liabilities and loss of reputation caused by violations
to the laws, regulations, and guidelines on health care wastes.

Health Care Waste Management System

Health care wastes generated by health care facilities generally follow a well-defined flow
from the point of generation down to their treatment and disposal. In the health care waste
management hierarchy, it is highly preferable to prevent the generation of wastes and to
reduce the quantity of generated wastes by using different methods of reusing, recycling,
and recovering wastes.
The most important step in the proper management of health care wastes is waste
minimization using an approach known as the Green Procurement Policy. This policy
involves two aspects-waste prevention and waste reduction. Through proper procurement
planning wastes are minimized even before their generation. Health care facilities are
encouraged to avail of services that are the least harmful to the environment and to
purchase less polluting products. Also, waste reduction from the source is implemented by
encouraging proper waste segregation to determine the nature and volume of generated
wastes to allow efficient waste management at the least cost.

Safely reusing, recycling, and recovering wastes are collectively termed as resource
development. Reusing refers to either finding a new application for a used material or using
the same product for the same application repeatedly. Safety and efficiency, however,
should be considered when reusing medical items and devices. For example, laboratory
glassware like glass culture tubes can be used repeatedly after decontamination. Recycling
refers to the processing of used materials into new products. Computer printouts from the
hospital, for example, can be sold and recycled into new paper products. The recovery of
waste, on the other hand, is defined in two ways: (1) energy recovery, whereby waste is
converted to fuel for generating electricity or for direct heating of premises and (2) as a
term used to encompass three subsets of waste recovery: recycling, composting, and energy
recovery.

For wastes that cannot be safely reused, recycled, or recovered, the end of pipe approach is
implemented. This approach to health care waste management involves two aspects:
treatment and disposal. Waste treatment is the process of changing the biological and
chemical characteristics of waste to minimize its potential to cause harm. Waste disposal, on
the other hand, refers to discharging, depositing, placing, or releasing any health care waste
into air, land, or water. Not all types of wastes require treatment. For example, food wastes
from in-patients can be disposed of through composting without the need for treatment.
However, some materials need to be treated first before disposal. Effluent wastewater from
hospitals, for example, needs to undergo sewage treatment prior to its release to the
environment.

Segregation, Collection, Storage, and Transport of Health Care Wastes

Health care facilities are tasked to ensure that generated wastes are properly and safely
managed. To ensure this, health care wastes must be segregated, collected, stored, and
transported while considering risk and occupational safety and compliance with existing
laws, policies, and guidelines. Hazardous wastes must never be mixed with general wastes
and there must be a waste management officer responsible for the management of the
health care wastes of a facility.

The most important step in the proper management of health care wastes is waste
minimization using an approach known as the Green Procurement Policy. This policy
involves two aspects-waste prevention and waste reduction.

Guidelines for the Proper labeling, marking and color coding for waste segregation in health
care facilities

Type of waste Specifications


Infectious Waste BIN

Strong leak-proof bin with cover labelled


"Infectious" with biohazard symbol
 

LINER

Yellow plastic that can withstand autoclaving


with 0.009 mm thickness and labelled
"Infectious Waste" with a tag indicating source
and weight of waste and date of collection; may
or may not have biohazard symbol

 
Pathological and Anatomical Wastes BIN

  Strong leak-proof bin with cover labelled


"Pathological/Anatomical Waste" with
biohazard symbol

LINER

Yellow plastic that can withstand autoclaving


with 0.009 mm thickness and labelled
"Pathological/Anatomical Waste" with a tag
indicating source and weight of waste and date
of collection. Biohazard symbol is optional
Sharps BIN 

  Puncture-proof container with wide mouth and


cover labelled "Sharps" with biohazard symbol 

LINER

Not applicable
Chemical Waste BIN

  Labelled "Chemical Waste"; For liquid


chemical waste, inside the bin is a disposal
bottle made of amber-colored glass with at least
4 liters capacity that is strong, chemical-
resistant, and leak-proof.

LINER

Yellow with black band plastic with 0.009 mm


thickness and labelled "Chemical Waste" with a
tag indicating source and weight of waste and
date of collection 
Pharmaceutical Waste BIN Strong leak-proof bin with cover labelled
"Pharmaceutical Waste" for expired drugs and
  drug containers and "Cytotoxic Waste" for
cytotoxic, genotoxic, and antineoplastic waste

LINER 

Yellow with black band plastic with 0.009 mm


thickness and labelled "Pharmaceutical Waste"
with a tag indicating source and weight of
waste and date of collection
 
Radioactive Waste BIN

                     Radiation proof repositories, leak-proof, and


lead-lined container labelled with name of
radionuclide and date of deposition with
radioactive symbol 

LINER 

Orange plastic with 0.009 mm thickness and


labelled "Radioactive" with a tag indicating
name of radionuclide and date of deposition.
General Waste BIN 

  Optional recycle symbol for recyclable non-


hazardous wastes; varying sizes depending on
the volume of waste.

LINER

Black or colorless plastic for non-biodegradable


and green for biodegradable with a thickness of
0.009 mm with a tag indicating source, weight
of waste, and date of collection

Type of Waste

In the implementation of a color-coding system for health care wastes, the following
practices should be observed:

1. Highly infectious waste must be disinfected at source. 

2. Anatomical waste including recognizable body parts, placenta waste, and organs should
be disposed through safe burial or cremation. 

3. Pathological waste must be refrigerated if not collected or treated within 24 hours. 

4. Sharps must be shredded or crushed before they are transported to the landfill. 

5. Chemical and pharmaceutical wastes shall be segregated and collected separately. Wastes
with high content of heavy metals, except mercury, should be collected separately and sent
to the waste treatment facility. Waste containing mercury must be collected separately.
Hazardous chemical waste shall never be mixed or disposed down the drain but shall be
stored in strong chemical resistant leak-proof containers or amber disposal bottles. Expired
and discolored pharmaceuticals should be returned to the pharmacy for temporary storage
to be returned to the manufacturer/ supplier. Pharmaceuticals shall be kept in their original
packaging for proper identification and prevention of possible reaction with other
chemicals. 

6. Radioactive waste has to be decayed to background radiation levels. If it has reached the
background radiation level and is not mixed with infectious or chemical waste, the
radioactive waste is considered as regular non-infectious waste. 

7. All waste bins must be properly covered to prevent cross contamination. 


8. Aerosol containers can be collected with the general waste.

Aside from the information placed on the tag, yellow plastic liners should also be labelled
with symbols appropriate for the types of waste they contain. The following are the symbols
used by the DENR Environmental Management Bureau together with other universally
accepted hazard symbols.

Health care facilities should have storage areas for general wastes, recyclable materials,
hazardous wastes, and phased-out mercury devices. Cytotoxic wastes must be stored
separately from other wastes in a designated secured location while radioactive wastes must
be stored in containers that can prevent dispersion of radiation during the period that their
radionuclide contents are being allowed to decay.

Proper collection and transport of health care wastes are important components in health
care waste management. Their implementation requires commitment and cooperation
among all the workers in the health care facility. There must be a regular on-site collection
of wastes and these must be transported using designated trolleys to the facility's waste
treatment area or waste storage facility. During on-site collection and transport, the
personnel hauling the wastes must be properly trained and should wear appropriate
personal protective equipment (PPE) to minimize the risk of infection and injury. For off-site
transport of health care wastes, only accredited DENR transporters and official waste
collectors are allowed to transport wastes from the health care facility to a
Treatment/Storage/Disposal (TSD) facility or to the final disposal site.

Treatment and Disposal of Health Care Wastes

Proper waste treatment is necessary to ensure that health care wastes do not pose harm to
the people and the environment. The manner of waste treatment usually varies and largely
depends on the type of waste that needs to be inactivated and its potential impact. Health
care wastes can be decontaminated either by sterilization or disinfection. Sterilization kills all
microorganisms while disinfection reduces the level of microorganisms present in the
material.

Listed below are the acceptable technologies and methods used in the treatment of health
care wastes.

1. Pyrolysis is the thermal decomposition of health care wastes in the absence of supplied
molecular oxygen in the destruction chamber where the said waste is converted into
gaseous, liquid, or solid form. This can handle the full range of health care wastes. Waste
residues may be in the form of greasy aggregates or slugs, recoverable metals, or carbon
black. These residues are disposed in a landfill. 

2. Autoclave is the use of steam sterilization to render waste harmless and is an efficient wet
thermal disinfection process. This method of using pressure and heat is widely used and the
usual setting is at 121 °C with a pressure of 15 psi for 15 to 30 minutes. Indicators such as
color-changing tapes or biological test ampules containing bacterial spores can be used to
check the validity of the sterilization. 

3. Microwave is a technology that typically incorporates some type of size reduction device.
Shredding of wastes is done before disinfection. In this process, waste is exposed to
microwaves that raise the temperature to 100 °C (237.6 °F) for 30 minutes. Microorganisms
are destroyed by moist heat which irreversibly coagulates and denatures enzymes and
structural proteins. 

4. In chemical disinfection, chemicals like sodium hypochlorite, hydrogen peroxide,


peroxyacetic acid, and heated alkali are added to health care wastes to or inactivate present
pathogens. It is recommended that sodium hypochlorite beach) with a concentration of 5
percent be used for chemical disinfection. This method, however, generates chemical wastes
from the used chemical disinfectants.

5. Biological process uses an enzyme mixture to decontaminate health care wastes. The
resulting by-product is put through an extruder to remove water for wastewater disposal.
The technology is suited for large applications and is also being developed for possible use
in the agricultural sector. 

6. Encapsulation involves the filling of containers with waste, adding and immobilizing
material, and sealing the containers. The process uses either cubic boxes made of high-
density polyethylene or metallic drums, that are three-quarters filled with sharps, or
chemicals or pharmaceutical residues. The containers or boxes are then filled up with a
medium such as plastic foam, bituminous sand, and cement mortar. After the medium has
dried, the containers are sealed and disposed in a landfill.

7. Inertization is especially suitable for pharmaceutical waste that involves the mixing of
waste with cement and other substances before disposal. For the inertization of
pharmaceutical waste, the packaging shall be removed, the pharmaceuticals ground and a
mixture of water, lime, and cement will be added. The homogenous mass produced can be
transported to a suitable storage site. Alternatively, the homogeneous mixture can be
transported in liquid state to a landfill and poured into municipal waste. The process is
relatively inexpensive and can be performed using relatively unsophisticated equipment.

After treatment, health care wastes are usually disposed in landfills. A landfill is an
engineered site designed to keep waste isolated from the environment. This site must
secure proper permits from DENR before it can accept wastes. Health care wastes that are
properly treated can be mixed with general wastes provided that it is certified by the DOH
that the organisms in the waste products are inert and cannot regenerate. For health care
facilities in far-flung areas with no access to landfills, disposal is usually through safe burial.
As a disposal method, safe burial is only applicable to treated infectious wastes, sharps,
pathological and anatomical wastes, small quantities of encapsulated/inertisized solid
chemical and pharmaceutical wastes and only allowed in health care facilities located in
remote areas. Used sharps and syringes can also be disposed using septic or concrete vaults
if the health care facility has no access to a TSD facility.

 Unit 10: PROFESSIONAL ORGANIZATIONS


Professional organizations are assemblages of professionals within a particular specialization
or professional field that come together for the purpose of collaboration, networking, and
professional development or advancement. Officers and members of professional
organizations serve to promote the particular professional field they are part of, to educate
the public on issues relevant to the industry, and to represent the interests of the industry in
various groups such as local and national government units, legislative bodies, and
international societies. These organizations also provide opportunities for professional
growth and continuing education by offering workshops, trainings and seminars, and by
publishing research journals. Interested individuals must pay membership fees and monthly
or yearly dues to avail or access the benefits and services that professional organizations
offer to their members.

Learning Outcomes

At the end of this unit, students will be able to:

1. Identify the professional organizations for Medical Technologists,


2. Discuss the benefits of joining a professional organization.
3. Recognize the history and profile of the accredited professional organization
for Medical Technologists and the organization of schools of Medical
Technology.

Presentation of Contents

In the Philippines, membership to an accredited professional organization (APO) or


accredited integrated professional organization (AIPO) is a requirement for hiring, retention,
and sometimes for the renewal of professional licenses. An APO or AIPO is a professional
society duly accredited by the Professional Regulation Commission (PRC) and the respective
Professional Regulatory Board (PRB).

There are several professional organizations that cater to Medical Technology/Medical


Laboratory Science professionals in the Philippines and abroad. Particularly, the Philippine
Association of Medical Technologists, Inc. (PAMET) is the accredited professional
organization and the leading national organization for Registered Medical Technologists in
the country. On the other hand, the Philippine Association of Schools of Medical
Technology and Public Health, Inc. (PASMETH) is the only professional organization of
schools for Medical Technology/Medical Laboratory Science. Its membership is also open to
deans, teachers, and clinical instructors in CHED-accredited educational institutions offering
Bachelor of Science in Medical Technology/Medical Laboratory Science.

Benefits of Membership in Professional Organizations

According to Ryan Tracey (Top 6 Benefits of Membership Organizations: Are They Still
Relevant to eLearning), the benefits of membership in professional organizations are
professionalism, education, perks, networking, profile, and recognition.

Professionalism

Professionals must adhere to the set of rules or code of ethics prescribed by the
professional society. Although this is the least in terms of value among the benefits, this is
an advantage for employers since adherence to prescribed rules shapes the conduct of a
professional.

Education
Professional organizations organize continuing professional development (CPD) activities
for their members through conventions, seminars, fora, workshops, and other activities of
similar nature. Also, most professional societies publish research journals which could serve
as avenues for improving the body of knowledge in a certain field.

Perks

Perks usually come in the form of monetary discounts on registration fees for professional
development activities of the organization. These discounts are offered exclusively to
members of the organization.

Networking

Activities conducted by professional organizations provide opportunities for building


networks in the field. Gatherings and other activities can be potential avenues for creating
long-term linkages and connections with other professionals in the field.

Profile

Membership in a professional organization can also build the career portfolio of a


professional. A professional society can also provide opportunities for speaking
engagements, career specialization, publication in research journals, and even scholarship
and training programs abroad.

Recognition

Professional organizations recognize their outstanding members and leaders in the practice
and special fields such as research, public service, and community engagements through
awards. This helps enhance one's professional profile.

Types of Professional Organizations

Professional organizations are classified based on their main function. A professional


organization can be multipurpose and could encompass all functions.

1. Accrediting Organizations

Accrediting organizations accredit curricular programs in educational institutions. An


educational institution applying for accreditation will then be visited by a technical
committee of experts from the accrediting agency to verify its compliance to the standards
of quality education. Membership in this type of professional organization is limited and is
usually institutional.

·         PAASCU

Philippine Accrediting Association of Schools, Colleges, and Universities 

·         PACUCOA

Philippine Association of Colleges and Universities Commission on Accreditation

2. Credentialing/Certifying Organizations

Credentialing or certifying organizations provide certification examinations for professionals.


Certified professionals are required to renew their licenses within a specified duration. In the
Philippines, credentialing professional organizations are not common due to the presence
of a government professional regulatory body, the Professional Regulation Commission
(PRC).

·         AMT

American Medical Technologists 

·         ASCP

American Society of Clinical Pathology 

·         ISCLT

International Society for Clinical Laboratory Technology 

·         NCA

National Certifying Agency for Medical Laboratory Personnel

3. Professional Societies

Professional societies are organizations that contribute to the continued development of a


specific group of professionals. Membership in a national society follows membership in its
local affiliate/chapter.

EXAMPLES OF LOCAL PROFESSIONAL SOCIETIES FOR MEDICAL TECHNOLOGIST

·         PAMET

Philippine Association of Medical Technologists, Inc. 

·         PASMETH

Philippine Association of Schools of Medical Technology

and Public Health, Inc. 

·         BRAP

BioRisk Association of the Philippines

·         PBCC

Philippine Blood Coordinating Council 

·         PCQACL

Philippine Council for Quality Assurance in Clinical Laboratories

·         PSM

Philippine Society of Microbiologists 


·         PhBBA

Philippine Biosafety and Biosecurity Association

EXAMPLES OF INTERNATIONAL PROFESSIONAL SOCIETIES FOR MEDICAL TECHNOLOGIST

·         ASCP 

American Society for Clinical Pathology 

·         AMT

American Medical Technologists 

·         AACLS

ASEAN Association for Clinical Laboratory Sciences 

·         AAMLS

Asia Association of Medical Laboratory Scientists 

·         AAMLT

ASEAN Association of Medical Laboratory Technologists 

·         ASCLS

American Society for Clinical Laboratory Science

·         IAMLT

International Association of Medical Laboratory Technologists 

·         IFBLS

International Federation of Biomedical Laboratory Science 

·         ISCLT

International Society for Clinical Laboratory Technologists

Professional Journals

Professional journals are publications containing scholarly studies on specific professional


Gelds. Sponsored by professional organizations, these journals publish articles and reviews
of books and past articles and serve as a forum for new articles. Compared to other types of
publications, professional journals are normally prepared by professionals in the field and
are peer-reviewed by experts.

It is significant for professionals, especially those involved in education and research, to


have their work published in professional journals. Journals help disseminate such work to
other practitioners in the field. Publishing research studies also contribute to the credibility
of an individual in a field of study. Some of the available professional journals for laboratory
professionals are:
Philippine Journal of Medical Technology

Asia-Pacific Journal of Medical Laboratory Science 

International Journal of Science and Clinical Laboratory 

Laboratory Medicine 

Medical Laboratory Observer

Clinical Laboratory Science

Advances for Medical Laboratory Professionals 

American Journal for Clinical Pathology

LabMedicine

PAMET

The Philippine Association of Medical Technologists, Inc. (PAMET) is the national


professional organization of Registered Medical Technologists in the Philippines. It is a
nonstock, non-profit organization.

The organization was founded on September 15, 1963 through the initiative of Crisanto G.
Almario, considered as the “Father of PAMET," at the Public Health Laboratory in Quiricada
St., Sta. Cruz, Manila.

Core Values

• Integrity
Integrity is the strict adherence to a moral code, reflected in transparent honesty,
truthfulness, accuracy, accountability for one's actions, and complete harmony in what one
thinks, says, and does. 

• Professionalism

Professionalism refers to the positive traits and values, moral responsibility, social
responsiveness, and behavioral outlook which makes one highly respectable and credible. 

•Commitment

Commitment is the unconditional, unwavering, and selfless dedication that one builds-in
into the practice of the profession characterized by initiative, creativity, and resourcefulness
to bring about quality health care and service to the public. 

• Excellence

Excellence is the high quality performance by advocating and adhering to international


standards making services globally comparable and competent. 

• Unity

Unity is the necessary linkage, support, involvement and sharing that will increase the
success and advancement of every individual member and the association in general.

PASMETH

The Philippine Association of Schools of Medical Technology and Public Health (PASMETH)
is the national organization of recognized schools of medical technology and public health
in the Philippines. It was established in 1970 with the hopes of maintaining the highest
standards of medical technology/public health education and fostering closer relations
among Medical Technology/Public Health schools.
PASMETH

The Philippine Association of Schools of Medical Technology and Public Health (PASMETH)
is the national organization of recognized schools of medical technology and public health
in the Philippines. It was established in 1970 with the hopes of maintaining the highest
standards of medical technology/public health education and fostering closer relations
among Medical Technology/Public Health schools.
PHISMETS

The Philippine Society of Medical Technology Students (PHISMETS) is the national


organization of all medical technology/medical laboratory Science students under the
supervision of PASMETH. It was first organized in 2002 during the leadership of former
PASMETH president. Dr. Zenaida c. Cajucom. The first PHISMETS advisers were Prof. Marilyn
Bala (CHS). Prof. Nova Aida C. Cajucom (FEU-NRMF) and Prof. Zennie B. Aceron (UST). The
organization became inactive due to inevitable reasons, but was reorganized on November
25, 2006 at FEU-NRMF headed by Dir. Magdalena Natividad. then Chair of the Committee
on Student Development, and Dean Bernard Ebuen.
Unit 11: CONTINUING PROFESSIONAL DEVELOPMENT

Most people associate learning with formal education. Aspiring professionals view the
attainment of quality education as a very important goal. However, the end of compulsory
education should not be viewed as freedom from educational obligation. Learning happens
through the course of a lifetime. It does not stop once graduation togas are donned and
diplomas are conferred.

Professionals should be lifelong learners. They are expected to have skills that are at par
with the requirements of companies to ensure the quality of services they will render. Thus,
a country's pool of professionals with up-to-date knowledge and skills translates to public
good. In the health care industry, for example, research suggests that higher level of
education among health care providers leads to better health care delivery and improved
patient outcomes.

Aside from public accountability, the importance of lifelong learning is magnified by the
dynamic flow of information in present time. We live in the Information Age where
computers, robotics, Internet, and other ICT tools are the primary drivers of economic
growth. The age of digital revolution requires professionals to be adept in manipulating
these ICT tools for the efficient delivery of services to the public.

Lifelong learning is a demand in an environment filled with global markets. Previously,


professional practice used to be confined within a nation's borders but because of
globalization, there is accelerated change and application of technology solutions in the
new millennium. Professional mobility across international borders is now common. Global
market players and employers prefer employees who continually acquire skills and
knowledge to enable them to adapt to the evolving needs of the global labor market. This is
important in the context of the Filipino nation because of its huge sector of overseas foreign
workers (OFW) with thousands of professionals being employed in other countries annually.

In the regional context, lifelong learning is also encouraged. The establishment of the
ASEAN Economic Community (AEC) in 2015 was a historical milestone and a huge stride
towards the regional economic integration of ASEAN Member States (AMS). As a step
towards regional integration and mobility of professionals in the region, the ASEAN
Qualifications Reference Framework (AQRF) was established. The AQRF is a common
reference framework that enables comparison of educational qualifications across AMS. One
of the objectives of the AQRF is to encourage the development of qualifications that can
facilitate lifelong learning.
Learning Outcomes

At the end of this unit, students will be able to:

1.    Discuss the importance of lifelong learning among laboratory professionals.

2.    Discuss the legal basis for the implementation of CPD in the Philippines.

3.    Discuss the process of application for and acquisition of CPD units for registered
professionals.

4.    Identify factors that affect the implementation of the CPD law in the Philippine context.

Presentation of Contents

Continuing Professional Development and its Legal Basis

Continuing Professional Development (CPD) is important to ensure the competency of


professionals. It is the maintenance, enhancement, and extension of knowledge, expertise,
and competence of professionals after attaining a bachelor's degree. As such, CPD is
the longest phase of professional education and is essential to the provision of evidence-
based health care in the contemporary health care setting. It provides a structured
framework to ensure improvement, progression, and career growth that benefits both
professionals and their respective organizations. Undertaking CPD facilitates continued
competence and personal and professional development, which in turn translate to
increased career worth that facilitates the advancement of the profession.

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


the competencies of health professionals, thus, making it mandatory. This is due to the
requirement for health practitioners to demonstrate and maintain competence in light of
the ever-changing scope of practice and technological advances in the field of medicine and
allied health. In fact, participation of medical laboratory scientists in CPD is a pre-requisite
for salary adjustment and career advancement in developed countries. The terms CPD
(Continuing Professional Development) and CPE (Continuing Professional Education) are
often used interchangeably. However, CPE more aptly refers to training which is linear and
formal. Training objectives in CPE are usually focused on learning a particular skill or set of
skills to improve professional competence. CPD, on the other hand, refers to the
development of one's knowledge, skills, and attitude significantly relevant to capability and
competency in his or her profession.
On July 25, 1995, former President Fidel V. Ramos issued Executive Order No. 266 entitled
"Institutionalization of the Continuing Professional Education (CPE) Programs of the Various
Professional Regulatory Boards (PRB) under the Supervision of the Professional Regulation
Commission (PRC).” Anticipating the stiff competition in the global professional labor
market as a result of the General Agreement on Trade in Services (GATS) treaty by the
World Trade Organization (WTO), the Philippine government has required all Filipino
professionals to undergo continuing education programs. The order was implemented
through PRC Resolution No. 381, Series of 1995 titled "Standardized Guidelines and
Procedures for the Implementation of the Continuing Professional Education (CPE)
Programs for all Professions" which took effect on November 13, 1995. Operations of CPE
Councils were further strengthened by Administrative Order No. 260 Series of 1996. E.O. No.
266 required the completion of 60 CPE units as a condition for the renewal of licenses of
professionals in the country. The said provision, however, was repealed by the passage of
the PRC Modernization Act of 2000 (R.A. 8981), on December 05, 2000. In 2004, PRC issued
Resolution No. 179 mandating the implementation of a voluntary CPE program for
professionals. This was repealed by PRC Resolution 2008-466 which emphasized the moral
obligation of professionals to obtain CPE units but in turn was repealed by PRC Resolution
2013-774 which revised the CPE/CPD Guidelines to CPD Guidelines. What was missing in
earlier orders, resolutions, and issuances, however, was a law that will empower the
implementation of CPD for professionals.

On July 21, 2016, Republic Act 10912 was passed into law and took effect on August 16,
2016. The said law mandated the strengthening of CPD programs for all regulated
professions and the creation of CPD Councils for each profession. It aims to continuously
improve the competence of professionals in accordance with international standards of
practice towards the uplifting of the general welfare, economic growth, and development of
the nation. The implementation of R.A. 10912 started on March 15, 2017 upon the effectivity
of the PRC Resolution No. 1032, also known as the Implementing Rules and Regulations of
R.A. 10912.

R.A. 10912 defines lifelong learning as "learning activities undertaken throughout life for the
development of competencies and qualifications of the professional," while CPD was
defined as "the inculcation of advanced knowledge, skills, and ethical values in a post
licensure specialization or in an inter- or multidisciplinary field of study, for assimilation into
professional practice, self-directed research, and/or lifelong learning." The said law seeks to
formulate and implement CPD programs for each profession in order to:

1. enhance and upgrade the competencies and qualifications of professionals for the
practice of their professions pursuant to the Philippine Qualifications Framework (PQF), the
AQRF, and the ASEAN Mutual Recognition Agreements (MRA); 

2. ensure international alignment of competencies and qualifications of professionals


through career progression mechanisms leading to specialization/sub-specialization; 

3. ensure the development of quality-assured mechanisms for the validation, accreditation,


and recognition of formal, non-formal, and informal learning outcomes, including
professional work experiences and prior learning; 

4. ensure maintenance of core competencies and development of advanced and new

competencies, in order to respond to national, regional, and international labor market


needs; and 
5. recognize and ensure the contributions of professionals in uplifting the general welfare,
economic growth, and development of the nation.

According to PRC, the overarching goal of CPD programs is the promotion of the general
welfare and interests of the public in the course of delivering professional services. Further.
CPD aims to:

1. continuously improve the quality of the country's reservoir of registered professionals by


updating them on the latest scientific/technological/ethical and other applicable trends in
the local and global practice of the professions; 

2. provide support to lifelong learning in the enhancement of competencies of Filipino


professionals towards delivery of quality and ethical services both locally and globally; and 

3. deliver quality CPD activities aligned with the Philippine Qualifications Framework (PQF)
for national and global comparability and competitiveness.

The CPD Process

Each profession has its own CPD council which is composed of (1) a member from the
Professional Regulatory Board (PRB) as chair, (2) the president or officer of an Accredited
Professional Organization (APO) as first member, and (3) the president or officer of the
national organization of deans or department chairpersons of schools, colleges, or
universities offering the course requiring the licensure examination as second member. In
the case of the medical technology profession, the first member is the president of the
Philippine Association of Medical Technologists, Inc. (PAMET) while the second member is
the president of the Philippine Association of Schools of Medical Technology and Public
Health, Inc. (PASMETH). The CPD Council is generally tasked to oversee the implementation
of the CPD program of the profession including the evaluation and monitoring of CPD
programs.

CPD providers need to apply their respective programs to the CPD Council at least 45 days
prior to the conduct of the CPD activity. The CPD Council will then evaluate the proposed
activity and designate the number of units to be assigned to it. The current list of CPD
providers for medical technologists is as follows:

1. Philippine Association of Medical Technologists, Inc. (PAMET) 

2. Philippine Association of Schools of Medical Technology and Public Health, Inc.


(PASMETH) 

3. Research Institute for Tropical Medicine (RITM) 

4. Philippine Blood Coordinating Council (PBCC)

5. Philippine Council for Quality Assurance in Clinical Laboratories 

6. National Reference Laboratory for HIV/AIDS and other Sexually Transmitted Diseases, San

    Lazaro Hospital (NRL-SLH/SACCL) 

7. University of Santo Tomas Faculty of Pharmacy - Department of Medical Technology

8. Far Eastern University - Nicanor Reyes Medical Foundation School of Medical Technology
9. Centro Escolar University - College of Medical Technology 

10. Newborn Screening Society of the Philippines

11. Asian Hospital

12. Philippine Society of Echocardiography 

13. Angeles University Foundation 

14. University of the Immaculate Conception 

15. University of the Philippines Manila - College of Public Health 

16. Bicol Sanitarium 

17. Far Eastern University Manila - Department of Medical Technology 

18. Department of Health Regional Office III 

19. Department of Health - Health Facility Development Bureau 

20. Ilocos Training and Regional Medical Center - Department of Laboratories

21. St. Luke's Medical Center - Quezon City

CPD is a mandatory requirement in the renewal of the professional identification card (PIC)
of all registered and licensed professionals under the regulation of PRC. Even professionals
working abroad and senior citizens are covered by the said requirement. Every professional
is required to renew his or her PIC every three years. For the said period, he or she must
acquire a stipulated number of CPD units. For registered medical technologists, the required
number of CPD units for PIC renewal is 45 units or an average of 15 units per year for three
years. Any excess number of CPD units cannot be carried over to the next three-year period
except for the credit units from doctorate and master's degrees or specialty trainings which
are only credited once during the compliance period.

During the initial implementation of the CPD requirement for PIC renewal, PRC instituted a
general transitory period as follows:

Required Number of CPD Units during the Transition Period

PIC Renewal Period Minimum CPD Units Required for the Profession
January to June 2017 0%
July to December 2017 30%
2018 60%
2019 onwards 100%

You might also like