LESSON I
HISTORY OF MEDICAL TECHNOLOGY PROFESSION
I.
Introduction
The practice of Medicine has been evolving and progressing as medical professionals
continue to search for innovative ways to improve patients’ lives. The practice of Medical
Technology can be traced back from the time of Ancient Egyptians, who conducted research to
diagnose and treat diseases. This practice and intense research continues on today, where
medical professionals and biomedical engineers are stepping up to come up with innovations to
create equipments and techniques for faster and more accurate ways to diagnose diseases.
Medical Laboratory Scientists or Medical Laboratory Technologists contributed a huge
part in this unending innovation, from literal tasting of urine samples, to microscopy to a more
sophisticated molecular techniques, which made possible the generation of reliable laboratory
test results helping physicians diagnose and treat diseases.
II.
Objectives
At the end of the learning session, the student must be able to:
III.
o
Identify the scope of the practice of Medical Technology
o
Outline the history of medical technology on a global context.
o
Arrange chronologically the history of medical technology in the United States.
o
Summarize chronologically the history of medical technology in the Philippines.
o
Identify completely the important personalities that played a significant role in the
progress of Medical Technology profession.
o
Enumerate the historical milestones in Medical Technology
Lesson Outline
A.
B.
C.
D.
E.
Scope and Nature of Medical Laboratory Science
History of Medical Technology on a Global context
History of Medical Technology in the United States
History of Medical Technology in the Philippine
Historical Milestones in Medical Technology
IV.
Lesson
A. Scope and Nature of Medical Laboratory Science:
o
Definition:
MEDICAL TECHNOLOGY also known as MEDICAL LABORATORY SCIENCE or
CLINICAL LABORATORY SCIENCE is a dynamic healthcare profession that deals with
the study and practice of diagnostic laboratory medicine.
ACCORDING TO PHILIPPINE MEDICAL TECHNOLOGY ACT OF 1969 : “It is an
auxiliary branch of Laboratory Medicine which deals with the Examinations on various
Chemical, Microscopic, Bacteriologic, and other medical procedures that will aid the
physician in the diagnosis, study, and treatment of diseases and promotion of health in
general”.
ANNA FAGELSON (1961) defined medical technology as the branch of medicine
concerned with the performance of laboratory determinations and analyses used in the
diagnosis and treatment of the disease and the maintenance of health.
RUTH HEINEMANN (1963) cited that the profession is an application of principles of
natural, physical, and biological sciences to the performance of laboratory procedures
which aid in the diagnosis and treatment of diseases.
WALTERS quoted that Medical Technology is a health profession concerned with
performing laboratory analyses in view of obtaining information necessary in the
diagnosis and treatment of disease as well as in the maintenance of good health.
o
Medical Technology as a Science
It is a science for it employs scientific investigation to come up with findings or
simply it involves investigative laboratory procedures to come up with meaningful
diagnostic findings or results
o
Medical Technology as an application of Science and Technology
Makes use of simple to sophisticated laboratory technologies in the
advancement of diagnosis of diseases and control of infection
B. HISTORY OF MEDICAL TECHNOLOGY ON GLOBAL CONTEXT
Insert tung history ka medtech
V.
Conclusion
Knowing the history of Medical Technology is important because it allows us to become
aware of the inventions and discoveries that paved the way to modern developments and trends
for more scientific and reliable methods in laboratory diagnosis.
From ancient times, to establishment of the first clinical laboratory the growth of profession
did not stop due to advance researches, innovations and inventions with an objective to provide
the best health care to the citizens of the world.
VI.
Lesson Activities
Read other resources and briefly respond to the following:
1. Relate the “four humors” of Hippocrates to the different body fluids.
2. Describe how the ancient medical practitioners perform urinalysis.
3. What will be your possible contribution as future professionals to the advancement of
the Medical Technology profession.
VII.
Agreement/Assignment/ Enrichment
In a Microsoft PowerPoint format make a brief historical development on how did
the practice of medical technology in you respective municipalities evolved
VIII.
References
Turgeon, M.L. (2012). Clinical Laboratory Science (6th ed.). Elsevier Mosby
McPherson, R.A. & Pincus, M.R. (2011). Henry’s Clinical Diagnosis and Management by
Laboratory Methods (22nd ed.). Philadelphia: Elsevier Inc.
Pagana, K. (2011). Mosby's Diagnostic and Laboratory Test Reference (10th ed.). Elsevier Mosby
LESSON II
Defining the Practice of the Medical Technology / Clinical Laboratory Science Profession
I.
Introduction
In Republic Act 5527 Medical Technology is defined as and auxiliary branch of laboratory
medicine which deals with the examination by various chemical, microscopic, bacteriologic, and
other medical laboratory procedures or technique which will aid the physical in the diagnosis,
study and treatment of disease and promotion of health in general.
All in all Medical technology is a part of health technology which encompasses a wide
range of health care products and in one way or another used to diagnose, monitor or treat
every disease or condition that affects humans.
II.
Objectives
At the end of the learning session, the student must be able to:
III.

discuss completely the practice of medical technology as to nature of the profession
in relation to detection and diagnosis of diseases

Explain comprehensively the practice of medical technology

Differentiate accurately the medical technology practice from other laboratory
personnel such as laboratory technicians, pathologists and alike.
Lesson Outline
A. Practice of Medical Technology Profession
1. Nature of Medical Technology
2. Role of Medical Technology/Medical Laboratory Science in disease detection and
diagnosis
B. Defining the Practice of other Laboratory Personnel
IV.
LESSON
A. PRACTICE OF MEDICAL TECHNOLOGY
1.
What Medical Technologist do?
According to RA 5527 (Philippine Medical Technology Act of 1969),
provided that person passed the corresponding Board Examination can perform
a. Examination of tissues, secretions and excretions of the human body and
body fluids by various electronic, chemical, microscopic, bacteriologic,
hematologic, serologic, immunologic, nuclear, and other laboratory
procedures and techniques either manual or automated:
b. Blood banking procedures and techniques;
c. Parasitologic, Mycologic and Microbiologic procedures and techniques;
d. Histopathologic and Cytotechnology; provided that nothing in this paragraph
shall inhibit a duly registered medical laboratory technician from performing
histopathologic techniques and procedures.
e. Clinical research involving patients or human beings requiring the use of
and/or application of medical technology knowledge and procedures;
f. Preparations and standardization of reagents, standards, stains and others,
provided such reagents, standards, stains and others are exclusively for the
use of their laboratory;
g. Clinical laboratory quality control;
h. Collection and preservation of specimens,
According to American Society for Clinical Laboratory Science
a.
b.
c.
d.
e.
Ensuring that appropriate clinical laboratory tests are ordered
Procuring clinical laboratory test samples in an efficient, timely manner;
Producing accurate clinical laboratory test results;
Correlating and interpreting clinical laboratory test data;
Disseminating clinical laboratory test information to clinicians and patients in
a timely manner;
f. Evaluating the outcome of clinical laboratory testing for each individual
patient and the entire health care system;
g. Utilizing qualified medical laboratory personnel.
2.
Who are allowed to practice Medical Technology in the Philippines?
A person who practice the profession is known as a Medical Laboratory
Technologist, likewise known as Medical Technologist. The person must be a
graduate of BS Medical Technology/BS Medical Laboratory Science/BS Public
Health who passed the licensure examination for Medical Technology.
3.
WHERE do Medical Technologists work?
Medical Technologists work in the laboratory. The following are different types of
laboratory where Medical Technologists work:
a. Clinical and Medical Laboratory - laboratories equipped for diagnostic tests
on tissue, blood and other patient samples. They can be subdivided into
various processes such as pathology, serology, histology, virology,
bacteriology and molecular biology with PCR- technologies.
b. Biosafety Laboratory - the containment of potentially harmful biological
agents.
c. Research and Development Laboratory
4.
WHAT are the different sections of Clinical Laboratory?
The different sections in a Medical Laboratory Includes:
a. Phlebotomy
b. Hematology
c. Clinical Chemistry
d. Immunology and Serology
e. Microbiology
f. Clinical Microscopy
g. Histopathology
h. Blood Donor Services, Blood Transfusion Services
5.
Who supervises a Medical Laboratory Technologist?
In Hospital based or free standing laboratory the Medical Laboratory
Technologist works under the supervision of a pathologist. Whereas in a school
based laboratory the Medical Technologist reports direct to the Department Head or
Dean.
6.
7.
What are the characteristics of Clinical/Medical Laboratory Practitioners ?
a. Problem Solvers
b. Focused
c. Good communication skills
d. Trustworthy
e. Efficient and self-reliant
f. Dignified and Respectable
g. Role Models
h. Self-motivated
What are the imitations of the roles and functions of Clinical Laboratory
Practitioners?
a. Medical Laboratory Practitioners are not allowed to perform roles beyond their
job scope unless they are truly knowledgeable about the procedure and no
patients or other professionals would be adversely affected.
b. Laboratory practitioners can perform both routine and special laboratory
examinations however some special tests such as Drug testing, Northern blotting
and other molecular diagnostic procedures require proper training and
certification.
c. A laboratory practitioner can participate in clinical trials or research activities
however it usually requires experience and a higher education such as a Postgraduate degree or a Master’s Degree.
d. Other limitations include
o
o
o
o
8.
Not allowed to prescribe medicine
Cannot give medical advice
Cannot offer primary healthcare or direct contact with patients except
during blood extraction
Cannot engage/handle medico-legal cases
What are the Ethical obligations of Medical Laboratory Technologist?
a.
Professional Behavior – maintain high standards in professional practice, act
within the professional code of ethics and become members of Professional
Organizations.
b. Responsibility – perform tasks assigned with integrity, diligently and effectively.
c.
Development – they must maintain and improve their skills and knowledge about
the profession, be updated with scientific advances, contribute and share
research findings for the benefit of mankind and those in the academe should
pursue post-graduate courses.
d. Collegiality – should share knowledge with colleagues.
e. Respect Laws and Regulations – be aware of the laws and regulations governing
the practice of Medical Technology and should apply it in the practice of their
profession.
f.
9.
Competence – equipped with technical skills and theoretical knowledge once
having passed the licensure examination.
The Code of Ethics of Medical Technology
Enter code of ethics
B. DEFINING THE PRACTICE OF OTHER LABORATORY PERSONNEL
1.
Medical and Clinical Laboratory Technicians
They are also called laboratory assistants for they technically work under the
supervision medical technologist because they graduates of BSMLS but fail to pass
the Medical Technology board examination. However their board exam rating is
between 70-74.9%, they can apply for a license as Medical Laboratory Technician
according to RA 5527 or the Philippine Medical Technology Act of 1969.
Scope of duties and responsibilities:
a. Perform less complex tests and Laboratory Procedures
o
o
o
o
o
o
o
b.
preparation of laboratory materials ex. extraction materials, culture media,
reagents, and chemical kits
labelling of specimens
preparation of apparatus and instruments
preparation of smears (hematology, histology, and microbiology)
recording of laboratory results
maintaining orderliness and cleanliness of the laboratory
in school setting – issue and accept laboratory materials before and after
experimentation
Carrying out an inventory of laboratory materials
o
done on a regular basis to ensure adequate supply of reagents and to know
what materials are to be requested for purchase
c. Preparation of patients for laboratory examination
o interview patients prior to specimen collection
o inform patients of the requirements for laboratory testing
2.
CYTOTECHNOLOGISTS
Laboratory practitioners specialized in the microscopic study of cells and cellular
abnormalities
Qualification:
o
o
o
Doctor of Medicine with Specialization in the Laboratory Pathology
Doctor of Medicine with residency training in Laboratory Pathology
Experienced and registered Medical Technologist
Duties and Responsibilities of Cytotechnologists
o
o
o
3.
Microscopically examine human cell samples to detect any signs of cancer
and other disease.
Issue final reports
Refers abnormal findings
HISTOTECHNOLOGISTS
They are registered medical technologists with experience or expertise in
histotechnology. They are the ones who prepare solid tissues such as biopsy samples
and tumors for examination under the microscope to detect cancer and other
abnormalities.
Duties and Responsibilities of Histotechnologists
o
o
Tissue processing
Cutting tissue to obtain very thin specimen
o
o
4.
Mounting on slide
Staining with special dyes
PHLEBOTOMY TECHNOLOGISTS
Phlebotomy is defined as an art of extracting blood samples from human
patients. Phlebotomists are laboratory practitioners specialized in blood collection/blood
extraction
5. BLOOD BANK TECHNOLOGISTS
Blood bank technologists specialized in screening and preparing blood for
transfusion.
Practice settings:
o
o
o
o
blood donor centers
transfusion services
reference laboratories
research facilities
Duties and Responsibilities of Blood Bank Technologists
o
o
o
o
o
o
o
o
Identifying and screening of donors
Blood typing
Perform blood collection
Blood group antigen testing
Cross matching
Antibody Identification
Screening of blood for infectious diseases
Investigate hemolytic diseases
6. Toxicologist
A toxicologist is a scientist who tests bodily fluids and tissue samples during
autopsies to determine the presence of toxins or chemicals. They work in laboratories
and use various methods to locate toxic levels of drugs or other poisons within the body.
If harmful agents are determined present, a toxicologist will measure the levels found
and identify if it likely contributed to the death of the patient. Additionally, many
toxicologists work to help solve criminal cases and will testify in court on behalf of their
lab findings.
V.
Conclusion
A medical laboratory scientist (MLS), also known as a medical technologist or clinical
laboratory scientist, works to analyze a variety of biological specimens. They are responsible
for performing scientific testing on samples and reporting results to physicians.
Medical laboratory scientists collaborate very closely with physicians and medical
laboratory technicians in diagnosing and monitoring disease processes, as well as monitoring
the effectiveness of therapy. Areas of medical laboratory training include microbiology,
chemistry, hematology, immunology, transfusion medicine, toxicology, and molecular
diagnostics.
Medical laboratory scientists have a wide variety of responsibilities and duties, including:








Examining and analyzing blood, body fluids, tissues, and cells
Relaying test results to physicians
Utilizing microscopes, cell counters, and other high-precision lab equipment
Cross matching blood for transfusion
Monitoring patient outcomes
Performing differential cell counts looking for abnormal cells to aid in the diagnosis of
anemia and leukemia
Establishing quality assurance programs to monitor and ensure the accuracy of test
results
Overseeing the work of a medical laboratory technician
LESSON III
Medical Technology/Clinical Laboratory Science Profession
I.
Introduction
A curriculum provides teachers, students, administrators and community stakeholders with a
measurable plan and structure for delivering a quality education. The curriculum identifies the
learning outcomes, standards and core competencies that students must demonstrate before
advancing to the next level. Teachers play a key role in developing, implementing, assessing
and modifying the curriculum. An evidenced-based curriculum acts as a road map for teachers
and students to follow on the path to academic success.
II.
Objectives
At the end of the learning session, the student must be able to:
III.
o
State the definition of curriculum
o
Itemize the different general education and professional courses included in the
Bachelor of Science in Medical Technology/Clinical Laboratory Science
o
Asses the importance of general education courses in the development of Medical
technologist/Clinical Laboratory Scientist
o
Rationalize the competencies of the professional in the 21st century
o
Identify the basic concepts of Outcomes-based education
o
Catalogue activities and processes to ensure accomplishment of requirements per
course and the program
Lesson Outline
A. B.S. Medical Technology (BSMT)/ Bachelor of Science in Medical Laboratory Science
(BSMLS) Curriculum
1. Definition of curriculum
2. BSMT/BSMLS
a. General Education
b. Professional Course
c. Internship training
3.
4.
5.
6.
IV.
Requirements for Graduation
Licensure Examination
Outcomes based education as applied in the program
Measurement and Evaluation
a. Types of Measurement
B. Competency skills of Medical Technology/ Clinical Laboratory Scientist in the 21st century
Lesson
1. Definition of Curriculum
The term curriculum refers to the lessons and academic content taught in a school or
in a specific course or program. In dictionaries, curriculum is often defined as the courses
offered by a school. Curriculum typically refers to the knowledge and skills students are
expected to learn, which includes the learning standards or learning objectives they are
expected to meet; the units and lessons that teachers teach; the assignments and
projects given to students; the books, materials, videos, presentations, and readings
used in a course; and the tests, assessments, and other methods used to evaluate
student learning.
An individual teacher’s curriculum, for example, would be the specific learning
standards, lessons, assignments, and materials used to organize and teach a particular
course.
When the terms curriculum or curricula are used in educational contexts without
qualification, specific examples, or additional explanation, it may be difficult to determine
precisely what the terms are referring to—mainly because they could be applied to either
all or only some of the component parts of a school’s academic program or courses.
2. The Bachelor of Science in Medical Technology/Bachelor of Science in Medical
Laboratory Science Curriculum
In reference to CHED Memorandum Order No. 13 series of 2017 Section 4, It is
said that HEI’s are allowed to design curricula suited to their own contexts and missions
provided that they can demonstrate that the same leads to the attainment of the required
minimum set of outcomes, albeit by a different route. In the same vein, HEI’s have
latitude in terms of curriculum delivery and in terms of specification and deployment of
human and physical resources and long as they can show that the attainment of the
program outcomes and satisfaction of program education objectives can be assured by
the alternative means they propose.
The Medical Technology/Medical Laboratory Science curriculum is stipulated in
Article V, Section 8 to 11 of the said CMO
o
Section 8: Curriculum Description
HEI’s offering Medical Technology/Medical Laboratory Science education may
exercise flexibility in their curricular offering. However Medical
Technology/Medical Laboratory Science courses as prescribed in the sample
program study shall be implemented.
o
Section 9: Minimum Curriculum
9.1. Components
9.1.1. General Education Core Courses:
Understanding the Self
Readings in Philippine History
The Contemporary World
Mathematics in the Modern World
Purposive Communications
Art Appreciation
Science, Technology and Society
Ethics
24 Units
3 units
3 units
3 units
3 units
3 units
3 units
3 units
3 units
9.1.2. General Education Elective Courses
GE General Elective 1
GE General Elective 2
GE General Elective 1
9 units
3 units
3 units
3 units
9.1.3.
General Education Mandated Course
The Life and Works of Jose Rizal
3 units
3 units
9.1.4.
Physical Education Courses
Physical Education 1
Physical Education 2
Physical Education 3
Physical Education 4
8units
2 units
2 units
2 units
2 units
9.1.5.
NSTP Courses
NSTP 1
NSTP 2
6 units
3 units
3 units
9.1.6.
Core Courses
Inorganic and Organic Chemistry
Analytical Chemistry
Biochemistry for Med Lab Science
Human Anatomy and Physiology with
Pathophysiology
Principles and Strategies of Teaching in
Med Lab Science
Biostatistics and Epidemiology
Health Information System for Med Lab Sci
25 units
4 units
4 units
5 units
Professional Courses
Principles of Medical Laboratory Science
Practice 1
Principles of Medical Laboratory Science
Practice 2
65 units
9.1.7.
4 units
2 units
3 units
3 units
3 units
3 units
Community and Public Health for Medical
Laboratory Science
Human Histology
Molecular Biology and Diagnostics
Med Tech Laws and Bioethics
Cytogenetics
Clinical Chemistry 1
Clinical Bacteriology
Clinical Parasitology
Hematology 1
Histopathologic and Cytologic Techniques
Laboratory Management
Clinical Chemistry 2
Hematology 2
Immunology and Serology
Immunohematology
Analysis of Urine and Body Fluids
Mycology and Virology
Seminar 1
Seminar 2
4 units
2 units
2 units
3 units
2 units
5 units
5 units
3 units
4 units
3 units
2 units
5 units
3 units
4 units
4 units
3 units
2 units
1 unit
1 unit
9.1.8.
Research Courses
Intro to Med Lab Science Research
Research Paper Writing and Presentation
5 units
2 units
3 units
9.1.9.
Clinical Internship Courses
Clinical internship 1
Clinical Internship 2
Medical Technology Assessment Program 1
Medical Technology Assessment Program 2
28 units
12 units
12 units
2 units
2 units
Summary of Units
General Education Core Courses
General Education Elective Courses
General Mandated Courses
Physical Education Courses
NSTP Courses
Core Courses
Professional Courses
Research Courses
Clinical Internship Courses
24 units
9 units
3 units
8 units
6 units
25 units
65 units
5 units
28 units
o
Program of Study (Sultan Kudarat State University)
FIRST YEAR - FIRST SEMESTER
Course
Code
GE 702
GE 708
MT 101 A
MT BIO 1
MT CHM
1
PE 101
NSTP 101
HIS 1
COURSE TITLE
Lec
Lab/
RLE
Purposive Communication
Understanding the Self
Principles of Medical Laboratory
Science 1
Human Anatomy and Physiology with
Pathophysiology
Organic and Inorganic Chemistry
3
3
0
0
U
nit
s
3
3
3
0
3
NONE
3
2
5
NONE
3
2
5
NONE
2
0
2
NONE
3
0
3
NONE
2
1
3
NONE
22
5
27
Le
c
3
3
3
Lab/
RLE
0
0
0
Un
its
3
3
3
3
2
5
2
2
1
0
3
2
3
0
3
2
3
5
21
6
27
Le
c
3
3
Lab/R
LE
0
2
Unit
s
3
5
2
2
1
0
3
2
2
0
2
Physical Fitness and Self-testing
Activities
National Service Training Program 1
Health Information System for Med Lab
Science
TOTAL
FIRST YEAR - SECOND SEMESTER
Course
COURSE TITLE
Code
GE 701
Mathematics in the Modern World
GE 704
Science Technology and Society
GE 703
Ethics
Analytical Chemistry (Qualitative and
MT CHM 2
Quantitative Chemistry)
Principles of Medical Laboratory
MT 101 B Science 2
PE 102
Rhythmic Activities
NSTP 102
MT 102
National Service Training Program 2
Community and Public Health for Med
Lab Science
TOTAL
SECOND YEAR - FIRST SEMESTER
Course
COURSE TITLE
Code
Elective 1 General Elective 1
MT CHM Medical Biochemistry
3
BIO-EPI
Biostatistics and Epidemiology
MT EDUC Principles and Strategies of
Teaching in Med Lab Science
MT 201
Cytogenetics
Pre-Req
NONE
NONE
Pre-Req
NONE
NONE
NONE
MT CHM
1
MT 101
A
PE 101
NSTP
101
MT 101
A& B
PreReq
NONE
MT
CHM 1
GE 701
NONE
MT BIO
1
MT 202
GE 709
GE 705
PE 103
Med Tech Laws and Bioethics
The Life and Works of Jose Rizal
The Contemporary World
Recreational Activities (Individual
and Dual)
TOTAL
SECOND YEAR - SECOND SEMESTER
COURSE TITLE
Course
Code
Elective 2
MT 203
MT 204
MT 205
GE 707
MT BIO 2
PE 104
3
3
3
2
0
0
0
0
3
3
3
2
23
3
26
Le
c
Lab/RL
E
Unit
s
General Elective 2
Laboratory Management
Clinical Parasitology
3
0
3
2
2
0
2
2
4
Clinical Bacteriology
3
2
5
Art Appreciation
3
0
3
Readings in Philippine
History
3
0
3
Human Histology
Team Sports
TOTAL
2
2
20
1
0
5
3
2
25
THIRD YEAR - FIRST SEMESTER
Course
COURSE TITLE
Code
Lab/
RLE
Uni
ts
General Elective 3
3
0
3
MT 301
Mycology and Virology
2
0
2
MT 302
Immunology and Serology
3
2
5
Clinical Chemistry 1
3
2
5
Analysis of Urine and Other Body
Fluids
2
1
3
Hematology 1
3
2
4
2
1
3
18
8
26
MT 303-A
MT 304
MT 305-A
MTR-A
Introduction to Med Lab Science
Research
TOTAL
Pre-Req
Elective
1
MT 202
NONE
MT BIO
1
L
ec
Elective 3
NONE
NONE
NONE
PE 102
NONE
MT BIO
1
PE 103
Pre-Req
Elective
2
MT BIO
1
MT 205
MT BIO
1, MT
CHEM 3
MT BIO
1, MT
CHEM 4
MT BIO
2
BIO EPI
THIRD YEAR - SECOND SEMESTER
Course Code
COURSE TITLE
MT 303-B
Clinical Chemistry 2
MT 305-B
Hematology 2
Immunohematology and
MT 306
Blood Banking
Histopathologic and
MT 307
Cytologic Techniques
Molecular Biology and
MT 308
Diagnostics
Med Lab Science Research
2 Paper Writing and
MTR-B
Presentation
TOTAL
THIRD YEAR MIDTERM
Course Code
COURSE TITLE
Total Quality Laboratory
Management with Practicum
MT 309
(108 hrs)
TOTAL
MT401-A
MT 402-A
Units
5
3
Pre-Req
MT 303-A
MT 305-A
3
2
5
MT 305-A
2
1
3
MT BIO 2
2
1
3
MT BIO 2
0
2
2
MTR-A
12
9
21
Lab/RLE
3
3
3
3
Lec
Lab/RLE
Units
12
12
2
0
2
NONE
1
3
0
12
1
15
NONE
Lec
0
Lab/RLE
12
Units
12
2
0
2
Seminar 2
1
0
1
Pre-Req
MTCI-1
MT 401A
MT 402A
TOTAL
3
12
15
Clinical Internship 1 (832
hours)
Medical Technology
Assessment
Seminar 1
TOTAL
FOURTH YEAR - SECOND SEMESTER
Course Code
COURSE TITLE
MT CI 2
Clinical Internship 2 (832 hrs)
Medical Technology
MT 401-B
Assessment
MT 402-B
Lab/RLE
2
1
Lec
FOURTH YEAR - FIRST SEMESTER
Course Code
COURSE TITLE
MT CI-1
Lec
3
2
One (1) Year Internship (28 Units)
SECTION
Clinical Chemistry
Clinical Microscopy and Parasitology
Hematology
Microbiology
Blood Banking
No. of Hours
300
200
300
250
200
Units Pre-Req
All Third
Year
6
subjects
6
Pre-Req
All Third
Year
subjects
Histopathologic Techniques and Cytology
Immunology and Serology
Laboratory Management
Phlebotomy
Total Number of Contact Hours
100
220
40
54
1664
Insert curriculum desc
3. Outcomes Based Education
Outcome-based education is a performance-based approach at the cutting edge
of curriculum development it offers a powerful and appealing way of reforming and
managing medical education.
The emphasis is on the product-what sort of a medical technologist will be
produced-rather than on the educational process. In outcome-based education the
educational outcomes are clearly and unambiguously specified. These determine the
curriculum content and its organization, the teaching methods and strategies, the
courses offered, the assessment process, the educational environment and the
curriculum timetable. They also provide a framework for curriculum evaluation.
A medical technologist is a unique combination of different kinds of abilities. A
three-circle model can be used to present the learning outcomes in medical education,
with the tasks to be performed by the medical technologist in the inner core, the
approaches to the performance of the tasks in the middle area, and the growth of the
individual and his or her role in the practice of laboratory medicine in the outer area.
Outcome-based education offers many advantages as a way of achieving this. It
emphasizes relevance in the curriculum and accountability, and can provide a clear and
unambiguous framework for curriculum planning which has an intuitive appeal.
It encourages the teacher and the student to share responsibility for learning and
it can guide student assessment and course evaluation. What sort of outcomes should
be covered in a curriculum, how should they be assessed and how should outcomebased education be implemented are issues that need to be addressed.
CMO 13 series of 2017 enumerated the program goals, program outcomes and
program indicators of the program
o
Program Goals: For graduates to
1. Develop the knowledge, skills, professional attitude and values in the
performance of clinical laboratory procedures needed to help the physician in
the proper diagnosis, treatment, prognosis and prevention of diseases;
2. Acquire critical thinking skills in Medical Technology/Medical Laboratory
Science;
3. Engage in research and community-related activities;
4. Participate in activities related to promoting the profession and actively
engage in lifelong learning activities undertakings; and
5. Develop collaborative and leadership qualities.
o
Program Outcomes and Indicators
1. Demonstrate technical competence in the performance of clinical laboratory
tests in aid of diagnosis, treatment and management of diseases vis-à-vis
biosafety and waste management
a. collect, handle and process biological specimens properly and safely;
b. perform laboratory testing accurately through the use of appropriate
techniques, skills and technology;
c. analyze and interpret laboratory test data;
d. monitor testing procedures, equipment and professional/ technical
competency using quality assurance methodologies;
e. operate instruments properly and perform appropriate preventive and
corrective maintenance;
f. adhere to all laboratory safety rules and regulations;
g. use computers and laboratory software competently;
h. discuss appropriate and novel technology for medical
technology/medical laboratory science application;
i. carry out the evaluation of new procedures and instruments; and
j. apply principles of educational methodology and laboratory
management.
2.
Demonstrate analytical and critical thinking skills in the workplace.
a. demonstrate skills in quality assurance and continuous quality
improvement;
b. evaluate the validity of the generated data and assure its reliability
before reporting;
c. recognize errors/problems and perform root cause analysis to establish
a course of action; and
d. apply the principles of educational methodology and resource
management.
3. Engage in the collection, analysis and projection of health information for
improving the health care management system.
a. collect health information for health care management;
b. analyze health information data;
c. interpret health information data; and
d. contribute in designing and planning course of action to address health
concerns and issues
4.
Demonstrate inter-personal skills, leadership qualities and ethical practice of
the profession.
a. work effectively with peers, and with multi-disciplinary and multi-cultural
team;
b. demonstrate good inter-personal skills with patients;
c. plan and organize activities;
d. practice professionalism;
e. practice the principles of data security and patient’s confidentiality; and
f. exhibit ethical behavior.
5.
Apply research skills in relevant areas of Med Tech/Medical Laboratory
Science practice.
a. identify research topic relevant to medical technology;
b. use appropriate research methods;
c. perform the research according to plan;
d. analyze and interpret research data; and
e. disseminate research results.
6.
Participate in community-oriented activities
a. engage in community-oriented activities;
b. plan and organize medical technology-related activities in the
community
c. apply the principles of good practice in community service and social
responsibility
d. implement, monitor, and evaluate activities in the communities
7. Engage in life-long learning activities
a. discuss trends/developments in Medical Technology/Medical Laboratory
Science practice
b. participate in professional organizations
c. engage in continuing professional development activities.
4.
8. Demonstrate effective teaching and communication skills
a. provide proper information and instruction to patients
b. implement proper classroom management and instruction
c. follow oral and written instructions
d. prepare correct communication materials
e. communicate effectively across multiple platforms
Assessment
Assessment is to determine whether or not the course’s learning objectives has
been met. According to Greenstein, 2011:Schmoker, 2011, “Educators need to focus on
What to teach, how to teach and How to assess it. Classroom assessment therefore, is
the observation of students in the process of learning and collection of frequent feedback
on the student’s learning.
o
Test

The teacher creates a test. It is an instrument designed to measure any
characteristics quality, ability, knowledge and skills, Further, its comprised of
items in the area it is designed to measure.
o
Measurement
 When a teacher checks thru test if the students have learned it is called
measurement. Simply it is the process of quantifying the degree to which
someone or something possesses a given trait.
o
Assessment
 Assessment is when a series of test is conducted and recorded for
continuous follow-up of the learner’s performance. It is the process of
gathering and organizing quantitative or qualitative data into an interpretable
form to have a basis for judgement or decision making. It is the prerequisite
to evaluation.
o
Evaluation
 Evaluation is the process of systematic interpretation, analysis, appraisal or
judgement of the worth of organized data as basis for decision making. It
involves judgement about the desirability of changes in students.
o
Kinds of Assessment:
a. Traditional Assessment: Refers to standardized testing that uses questions
with a limited number of answer choices. It includes multiple choice, true or
false and some short answer responses. Uses Paper and. Pen objective
test.
One of the primary benefits of traditional assessment is the ease with
which administrators and admission professionals can analyze and
compare students scores. Standardize testing that relies entirely on
quantifiable responses that is easy to score. Test makes can categorize
questions to determine which areas students excel in and which they have
difficulty with. Students’ results are comparable overtime and across a
large diverse group of students.
Traditional assessment methods have the disadvantage of lacking real
world context. Students answer questions one by one without the need to
apply long term critical reasoning skills. They also lack chances to
demonstrate their reasoning skills despite of lack of knowledge about a
question’s specific subject matter.
b. Alternative Assessment:
Alternative assessments are used to determine what students can
and cannot do, in contrast to what they do or do not know. Use methods
other than Pen-and-Paper objective test which includes performance test,
projects, portfolios, journal, essays and the like.
c.
Authentic Assessment:
It is an approach to measure student performance in a direct,
relevant way to see if the learning objectives were met. The goal of
authentic assessment is to enhance the learning process and help
students gain knowledge while completing tasks that are beneficial to
their “real-world” experiences.
o
Types of Assessment
a. Formative assessment
A formative assessment refers to a low-stakes assessment that
does not normally contribute towards a student’s final grade. A formative
assessment may include summarizing the main points in a lecture or a
weekly quiz to test comprehension of the reviewed content. Students’
feedback on these assessments is used to improve their learning while
they’re still learning. These assessments are used to inform in-process
teaching and allow instructors to personalize their course to meet students’
needs.
Formative assessment is also used to provide ongoing feedback to
both teachers and students. Teachers can then improve their teaching while
students can improve their learning based on their achievement. These
assessments help students identify their strengths and weaknesses in
specific areas and help faculty address students’ struggles immediately.
b. Summative assessment
Summative assessment is an assessment administered at the end of an
instructional unit in a course. These assessments are intended to evaluate
student learning by comparing performance to a standard or benchmark.
They are often high-stakes, meaning they have a high point value. Examples
of summative assessments include midterm exams, a final exam or a final
project.
Summative assessments are given to students at the end of an
instructional period. They are evaluative rather than diagnostic and are used
to measure whether a course’s learning objectives were met. Unlike formative
assessments, summative assessments are formal and involve clear
instructions, expectations and grading rubrics to measure student
comprehension.
c. Diagnostic assessment
A diagnostic assessment is a form of pre-assessment where teachers
can evaluate students’ strengths, weaknesses, knowledge and skills before
their instruction. An identical assessment may be given post-instruction to
identify if students have met a course’s required learning objectives. With this
form of assessment, teachers can plan meaningful and efficient instruction
and can provide students with an individualized learning experience. Written
by students, the diagnostic assessment is a tool for teachers to better
understand what students already know about a topic when submitted before
the start of a course.
A diagnostic assessment refers to an assignment written at the
beginning and end of a course. Post-course assessments can be compared
with pre-course assessments and can show students’ potential improvement
in certain areas. These assessments allow the instructor to adjust the
curriculum to meet the needs of current—and future—students.
V.
Conclusion
o
The term curriculum refers to the lessons and academic content taught in a school or
in a specific course or program
o
The Bachelor of Science in Medical Technology/Bachelor of Science in Medical
Laboratory Science Curriculum is in reference to CHED Memorandum Order No. 13
series of 2017
o
The table indicates the comparison of CHED curriculum and that of SKSU
SUMMARY OF COURSES
General Education Courses
Electives
Mandated Course- Life of Rizal
Other Courses - TQM
Professional Courses
Core Courses
Clinical internship
Research Courses
Physical Education Courses
NSTP Courses
TOTAL
o
o
SKSU
CHED
Remarks
UNITS
24
9
3
6
71
28
28
5
8
6
188
24
9
3
0
65
25
28
5
8
6
173
additional 6 units
additional 6 units
additional 3 units
15
CMO 13 series of 2017 enumerated the program goals, program outcomes and program
indicators of the program
Assessment is to determine whether or not the course’s learning objectives has been
met.
LESSON IV
Professional Organizations
I.
Introduction
A professional organization, sometimes referred to as a professional association or professional body,
exists to advance a particular profession, support the interests of people working in that profession and serve
the public good. It facilitates innovation, communication and connection. A professional organization
typically requires member dues, has an elected leadership body and includes a range of subcommittees or
functional areas. Professional organizations can be both national or international, and often have close ties to
colleges and universities with degree programs in that field.
II.
Objectives
At the end of the learning session, the student must be able to:
III.
o
Identify the professional organizations for Medical Technologists
o
Appraise the benefits of joining a professional organization
o
Enumerate the different types of professional organization
o
Explain the nature of each professional organization, and
o
Outline the history and profile of the accredited professional organization for Medical
Technologists and the organization of schools of Medical Technology.
Lesson Outline
A.
B.
C.
D.
What is a Professional Organization
Benefits of joining Professional Organizations
Types of Professional Organization
PAMET
1. History
2. First Organizational Meeting
3. Insignia
4. Roster of Presidents
5. Local Chapters
E. PASMETH
1. History
2. Seal
3. Roster of Presidents
F. PHISMETS
G. Other Foreign Societies
IV.
Lesson
1. What is a professional Organization?
A Professional Organization is an association that is formed to further the interests
of people engaged in a specific profession, to advance a particular profession and serve the
public good. Most of them are a non-profit organization that is dedicated to fulfilling the
interest of its members by facilitating connection, communication, and innovation.
A Professional Organization has an elected body that can be international or national.
These organizations are known by several names like



Professional society
Professional body
Professional association
A Professional Organization is entrusted with overseeing the legitimate practice of the
occupation. Many such organizations are involved in examining the skills necessary to
practice a profession and granting a certificate to signify that the said individual is qualified
in that subject area.
2.
What are the benefits of joining professional organizations?

Enhance your knowledge
Staying informed about the latest developments in your specific field is very
important as it keeps you up to date about all the relevant information and happenings.
Professional Organizations most often offer lectures, seminars or courses to inform its
members about the trends, research or innovations that have occurred in the recent
past. It proves a blessing in the long run and is an important reason to join a
Professional Organization.

Take charge of your career
Professional Organizations have job listings that are available only to their
members and being part of such an association will help in finding the targeted job
posting easily and take charge of your career

Build a better resume
When a person is associated with a Professional Organization, it shows his
dedication to staying connected with his profession. Most of these organizations have
career resources that help with the effective cover letter or resume writing. Listing
yourself as a member of a specific organization is a way to impress your future
employees and further your career.

Networking

Joining a Professional Organization provides numerous opportunities to connect
on a local and global scale and gain a sense of security. Making connections is essential
in this day and age, and these associations help in reaching professional goals.

Develop skills
Being a part of a Professional Organization provides individual with various
opportunities to develop his skills and boost personal growth

Be a leader
Professional Organization is an excellent platform that can help in the growth of
leadership qualities.

Become a mentor
Participating in seminars, discussion boards, and chat shows helps in increasing
your network. This opens doors to opportunities and contacts. If a person is interested in
giving back to others through mentorship, then it is a sound platform that will give you a
chance to become a mentor

Support system
Professional Organizations help a person to come out of his shell and make new
friends. It is an opportunity to work for your society through these associations and help
others. We are living in an age where there is strength in numbers as you become a part
of an established entity that will always work as your support system. This will motivate a
person to broaden his horizons and reach for new goals
3.
What are the different types of professional organizations?

Member -benefit professional associations
These organizations provide its members numerous resources like resume
building, networking and peer support to advance their careers. They focus on making
sure that their members can take advantage of available resources through conferences,
seminars, and journals.

Designation-granting associations
These types of Professional Organizations provide a certification to its members to
show that they are adept in this field. The certificate is naturally issued when the
members complete the learning process and demonstrate their expertise and knowledge
by passing the exams. In a designation-granting Professional Organization, the
members have to renew their certificates every few years.
 Certifying bodies
These are types of Professional Organizations that issue certifying credentials to its members
when they can meet the set requirements, for instance, particular professional experience or
education. The primary purpose of a certifying body is to issue certifications and keep a track

Professional regulatory bodies
These types of Professional Organizations follow the federal and state guidelines
to serve the public and maintain expectations of the industry. They establish licensing
and certification requirements and can exclude members who do not follow the set
procedure
4. Professional organizations of Medical Technologists in the Philippines
Mga pasmets chuchu
LESSON V
Continuing Professional Development
I.
Introduction
Continuing professional development (CPD) refers to the process of tracking and
documenting the skills, knowledge and experience that you gain both formally and informally
as you work, beyond any initial training. It is a record of what you experience, learn and then
apply. It can also be referred to as a portfolio documenting your development as a
professional.
Most professional bodies now adopt the concept of CPD and this can be a requirement of
membership for some of the professional bodies. The purpose of CPD is to help professionals
and individuals reflect, review and document their learning and also to develop and update
their professional knowledge and skills.
In the same vein, the aim of CPD can be associated to improving work performance,
enhancing career prospects, increasing learning capacity, encouraging involvement in, and
commitment to, lifelong learning and being adaptable to, and prepared for changes in industry.
II.
Objectives
At the end of the learning session, the student must be able to:
III.
o
recognize the importance of lifelong learning among laboratory professionals
o
Assess the legal basis for the implementation of CPD in the Philippines.
o
summarize the process of application for and acquisition of CPD units for registered
professionals
o
Identify factors that affect the implementation of the CPD law in the Philippine
context.
Lesson Outline
A. Lifelong Learning for Professionals
B. Continuing Professional Development and its Legal Basis
C. The CPD Process
IV.
Lesson
1.
What is lifelong learning?
Lifelong learning may be broadly defined as learning that is pursued throughout life:
learning that is flexible, diverse and available at different times and in different places.
Lifelong learning crosses sectors, promoting learning beyond traditional schooling and
throughout adult life (i.e. post-compulsory education). This definition is based on Delors’
(1996) four ‘pillars’ of education for the future.

Learning to know - mastering learning tools rather than acquisition of structured
knowledge.

Learning to do – equipping people for the types of work needed now and in the
future including innovation and adaptation of learning to future work environments.

Learning to live together, and with others – peacefully resolving conflict, discovering
other people and their cultures, fostering community capability, individual
competence and capacity, economic resilience, and social inclusion.

Learning to be – education contributing to a person’s complete development: mind
and body, intelligence, sensitivity, aesthetic appreciation and spirituality.
This is underpinned by "Learning to Learn".
Further, The European Lifelong Learning Initiative defines lifelong learning as “...a
continuously supportive process which stimulates and empowers individuals to acquire
all the knowledge, values, skills and understanding they will require throughout their
lifetimes and to apply them with confidence, creativity and enjoyment, in all roles
circumstances, and environments” (Watson, 2003).
Lifelong Learning has assumed immense importance in the policies and practices of
a number of international agencies, national governments and institutions of learning in
recent years. An increasing number of governments, policy makers and decision-makers
has concluded that a lifelong approach to learning should be instituted and deployed as
one of the main lines of attack on some of the major economic and social problems
needing to be addressed as we approach the twenty-first century.
2.
What are the benefits of CPD?
o
CPD ensures your capabilities keep pace with the current standards of others in
the same field.
o
CPD ensures that you maintain and enhance the knowledge and skills you need
to deliver a professional service to your customers, clients and the community.
o
CPD ensures that you and your knowledge stay relevant and up to date. You are
more aware of the changing trends and directions in your profession. The pace of
change is probably faster than it’s ever been – and this is a feature of the new
normal that we live and work in. If you stand still you will get left behind, as the
currency of your knowledge and skills becomes outdated.
o
CPD helps you continue to make a meaningful contribution to your team. You
become more effective in the workplace. This assists you to advance in your
career and move into new positions where you can lead, manage, influence,
coach and mentor others.
o
CPD helps you to stay interested and interesting. Experience is a great teacher,
but it does mean that we tend to do what we have done before. Focused CPD
opens you up to new possibilities, new knowledge and new skill areas
o
CPD can deliver a deeper understanding of what it means to be a professional,
along with a greater appreciation of the implications and impacts of your work.
o
CPD helps advance the body of knowledge and technology within your
profession.
o
CPD can lead to increased public confidence in individual professionals and their
profession as a whole.
o
CPD contributes to improved protection and quality of life, the environment,
sustainability, property and the economy. This particularly applies to high risk
areas, or specialized practice areas which often prove impractical to monitor on a
case by case basis.
3. What is the difference of Continuing Professional Education (CPE) and Continuing
Professional Development (CPD)?
Across borders, particularly in Europe, the term CPD is used more often than
CPE. CPE more properly refers to training which is linear and formal. Training
objectives are usually focused on learning a particular skill or set of skills to improve
professional competence. CPD refers both to training and knowledge, skills and
attitude development significantly relevant to capability and competency in one’s
profession. PRC uses both terms: CPE and CPD. In this issue, we will talk about
some features of an institution-based CPD.
4.
Cite the legal basis of CPD?
o
Article 12 of the Constitution recognizes role of professionals in nation building
and provides for sustained development of a reservoir of professionals.
o
July 25, 1995, former President Fidel V. Ramos issued Executive No. 266
entitled “Institutionalization of the Continuing Professional Education (CPE)
Programs of the various Professional Regulatory Boards (PRB’s) under the
supervision of Professional Regulation Commission. This is to address 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 trough
PRC Resolution No. 381, series of 1995 titles “Standardized Guideline and
Procedures for the Implementation of the Continuing Professional Education
(CPE), which took effect on November 13, 1995.
o
Administrative Order No 260 series of 1996 operations of CPE councils were
further strengthened
o
E.O. No 266 required the completion of 60 CPE units as a condition for the
renewal of licenses of professionals in the country. This Executive order was
repealed by the passage of the PRC Modernization Act of 2000 (RA 8981) on
December 5, 2004.
o
In 2004, PRC issued Resolution No. 179 mandating the implementation of a
voluntary CPE program for professionals, that has been repealed by PRC
resolution 2008-466 which emphasized the moral obligation of professionals to
obtain CPE units but again repealed by PRC Resolution 2013-774 which revised
the CPE/CPD guidelines to CPD guidelines.
o
July 21, 2016, Republic Act 10912 was passed into law and took effect on
August 16, 2016. The law mandated the strengthening of CPD programs for all
regulated professions and the creation of CPD councils for each profession.
o
As defined Republic Act No. 10912 is an Act Mandating and Strengthening the
Continuing Professional Development Program for All Regulated Professions,
Creating Continuing Professional Development Council, and Appropriating Funds
Therefor, and for Other Related Purposes.
o
Section 4 and 5 of RA 10912 seek to formulate and implement CPD programs for
each profession for the purpose of as discussed:
o
Section 4. Strengthening the CPD Program.— There shall be
formulated and implemented CPD Programs in each of the regulated
professions in order to:
(a) Enhance and upgrade the competencies and qualifications of
professionals for the practice of their professions pursuant to the
(Philippine Qualification Framework)PQF, the AQRF and the ASEAN
Mutual Recognition Agreement (MRAs);
(b) Ensure international alignment of competencies and qualifications of
professionals through career progression mechanisms leading to
specialization/sub-specialization;
(c) Ensure the development of quality assured mechanisms for the
validation, accreditation and recognition of formal, nonformal and
informal learning outcomes, including professional work experiences
and prior learning;
(d) 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
(e) Recognize and ensure the contributions of professionals in uplifting
the general welfare, economic growth and development of the nation.
o
Section 5. Nature of CPD Programs. - The CPD Programs consist of
activities that range from structured to nonstructured activities, which
have learning processes and outcomes.
o
These include, but are not limited to, the following:
(a) Formal learning;
(b) Nonformal learning;
(c)
(d)
(e)
(f)
5.
Informal learning;
Self-directed learning;
Online learning activities; and
Professional work experience.
What is the CPD Process?
RA 10912 under section 6, 7 and 8 describe the formation and responsibility of
the CPD council, PRC and the PRB’s
o
Section 6. Powers, Functions and Responsibilities of the PRC and the Professional
Regulatory Boards (PRBs).— The PRC and the PRBs shall undertake the overall
implementation of the CPD Programs, and for this purpose, shall:
o
(a) Organize CPD Councils for each of the regulated professions and promulgate
guidelines for their operation;
(b) Review existing and new CPD Programs for all of the regulated professions;
(c) Formulate, issue, and promulgate guidelines and procedures for the
implementation of the CPD Programs;
(d) Coordinate with the academe, concerned government agencies, and other
stakeholders in the implementation of the CPD Programs and other measures
provided under this Act; and
(e) Coordinate with concerned government agencies in the development of
mechanisms and guidelines, in the grant and transfer of credit units earned from
all the learning processes and activities, pursuant to this Act.
o
Section 7. CPD Council. - There is hereby created a CPD Council in each of the
regulated professions, which shall be under the supervision of the concerned PRB.
Every CPD Council shall be composed of a chairperson and two (2) members.
The chairperson of the CPD Council shall be the member of the PRB so
chosen by the PRB concerned to sit in the CPD Council.
The first member shall be the president or officer of the AIPO/APO duly
authorized by its Board of Governors/Trustees. In the absence of the AIPO/APO, the
PRB concerned shall submit within ten (10) working days from notification of such
absence, a list of three (3) recommendees from the national professional
organizations. The PRC shall designate the first member within thirty (30) days from
receipt of the list.
The second member shall be 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. In the absence of such
organization, the PRB concerned shall submit, within ten (10) working days from
notification of such absence, a list of three (3) recommendees from the academe.
The PRC shall designate the second member within twenty (20) working days from
receipt of the list.
The term of office of the chairperson of the CPD Council shall be coterminous
with his/her incumbency in the PRB unless sooner replaced by the PRB concerned
through a resolution, subject to the approval of the PRC. The first and second
members shall have a term of office of two (2) years unless sooner replaced through
a resolution by the AIPO/APO concerned or the organization of deans or heads of
departments, respectively. However, members of the CPD Council who are
appointed by the PRC may be replaced before the end of the two (2)-year period,
upon the recommendation of the PRB through a resolution.
o
Section 8. Powers, Functions and Responsibilities of the CPD Council. - The CPD
Council for each profession shall:
(a) Ensure the adequate and appropriate provision of CPD Programs for their
respective profession;
(b) Evaluate and act on applications for accreditation of CPD Providers and their
CPD Programs;
(c) Monitor and evaluate the implementation of the CPD Programs;
(d) Assess and/or upgrade the criteria for accreditation of CPD Providers and their
CPD Programs on a regular basis;
(e) Develop mechanisms for the validation, accreditation and recognition of selfdirected learning, prior/informal learning, online learning, and other learning
processes through professional work experience;
(f)
Conduct researches, studies and benchmarking for international alignment of
the CPD Programs;
(g) Issue operational guidelines, with the approval of the PRC and the PRB
concerned; and
(h) Perform such other functions related or incidental to the implementation of the
CPD.
6.
How many CPD credit units can be earned by a professional for a particular activity.
The number of CPD credit units assigned for a CPD activity are listed in
General Matrix of CPD Activities
7. How many CPD credit units are required for a Medical Technologist for professional
incense renewal?
For Medical Technologists and Medical Laboratory Technicians, pursuant to
Resolution No. 07, s. 2018, of the Professional Regulatory Board of Medical
Technology, the following is the transitory period for the compliance of their credit
units:
Year of Renewal
2018
2018 onwards
Required No. of Units
Medical
Medical Lab.
Technologists
Technician
30
20
45
30
LESSON VI
Nature of the Clinical Laboratory
I.
Introduction
Clinical laboratories are healthcare facilities providing a wide range of laboratory
procedures which aid the physicians in carrying out the diagnosis, treatment, and
management of patients. These laboratories are manned by medical technologists (clinical
laboratory scientists) who are trained to perform various tests to samples of biological
specimens collected from its patients. Most of the clinical laboratories are situated within or
near hospital facilities to provide access to both physicians and their patients.
II.
Objectives
At the end of the learning session, the student must be able to:
III.
o
Classify the different types of clinical laboratory
o
Categorize different types of laboratories
o
Discover the salient points of the laws governing the establishment, operation, and
maintenance of Clinical Laboratory in the Philippines
o
Indicate the importance of Quality Assurance in the Clinical Laboratory
o
Differentiate the basics of internal and external quality assurance.
o
List the different National Reference Laboratory and functions of each
o
Trace the laboratory cycle testing and the role of medical technologist on each cycle.
o
Presented a sample floor plan of a clinical laboratory
Lesson Outline
A. Clinical laboratory
1. Basics Concepts
2. Types of Clinical Laboratory according to:
a. Function
b. Ownership
c. Service Capability
3. Laws on the operation, maintenance and Registration of Clinical Laboratory in
the Philippines
a. RA 4688
b. AO 59 series of 2001
4. Sections of the Clinical Laboratory
a. Clinical Chemistry=Routine and Special Chemistry
b. Hematology
c. Immunohematology/Blood Banking
d. Medical Microbiology
e. Clinical Microscopy
f. Parasitology
g. Anatomic pathology Laboratory
h. Special laboratory
5. Cycle of Clinical Laboratory Testing
a. Pre-analytical
b. analytical
c. Post-analytical
B. Quality Assurance in the Clinical Laboratory
1. Internal quality assurance
2. External quality assurance
3. Continuous quality improvement
IV.
Lesson
1.
What is a CLINICAL LABORATORY?
o An essential component of the health institution. The main purpose of a clinical
laboratory is to provide accurate and reliable information to medical doctors for the
diagnosis, prognosis, treatment and management of diseases.
o Involved in research community, outreach, programs, surveillance, infection control in
the hospital and community settings, information dissemination, and evaluation of the
applicably of current and innovative diagnostic technologies.
o A place where specimens collected from individuals are processed, analyzed,
preserved and properly disposed.
2. What Law controls the Operation, Maintenance, and Registration of Clinical laboratories
in the Philippines?
A. REPUBLIC ACT NO. 4688, June 18, 1966
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.
SEC. 2. It shall be unlawful for any person to be professionally in-charge of a
registered clinical laboratory unless he is a licensed physician duly qualified in laboratory
medicine and authorized by the Secretary of Health, such authorization to be renewed
annually.
No license shall be granted or renewed by the Secretary of Health for the operation
and maintenance of a clinical laboratory unless such laboratory is under the
administration, direction and supervision of an authorized physician as provided for in the
preceding paragraph.
SEC. 3. The Secretary of Health, through the Bureau of Research and Laboratories
shall be charged with the responsibility of strictly enforcing the provisions of this Act and
shall be authorized to issue such rules and regulations as may be necessary to carry out
its provisions.
SEC. 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.
SEC. 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.
SEC. 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.
SEC. 7. All Acts or parts of Acts which are inconsistent with the provisions of this Act
are hereby repealed.
SEC. 8. This Act shall take effect upon its approval.
Approved, June 18, 1966.
B. ADMINISTRATIVE ORDER 59 S. 2001 CLINICAL LABORATORY LAW IRR ON RA
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.
The implementing guidelines of RA 4688 are contained in AO no. 59 s. 2001.
Section 1. Title
The 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 RA 4688 Clinical Laboratory
Law consistent with E.O 102 s. 1999: Redirecting the functions and operations of the
DOH.
The DOH, through the BHFS – Bureau of Health Facilities and Services in the Health
Regulation Cluster, shall exercise the regulatory functions under these rules and
regulations.
Section 3. Purpose
These rules and regulations are promulgated to protect and promote the Health of
the people by ensuring availability of clinical laboratories that are properly managed with
adequate resources, with effective and efficient performance through compliance with
quality standards.
Section 4. Scope
4.1. These regulations shall apply to all entities performing the activities and
functions of clinical laboratories which shall include the examination and analysis of any
or all samples of human and other related tissues, fluids, secretions, excretions,
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.
4.2 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
1.1.
Clinical Pathology Includes Hematology, Clinical Chemistry, Microbiology
Parasitology, Mycology, Clinical Microscopy (AUBF), Immunology and
Serology, Immunohematology, Blood Banking, Laboratory Endocrinology,
Toxicology and Therapeutic Drug Monitoring and other similar disciplines.
1.2.
Anatomic Pathology Includes Surgical Pathology, Immunohistopathology,
Cytology, Histopathology, Autopsy and Forensic Pathology.
2. Classification by INSTITUTIONAL CHARACTER
2.1.
2.2.
Hospital-based laboratory- Laboratory that operates within a hospital
Non-hospital based laboratory- Laboratory that operates on its own.
3. Classification by SERVICE CAPABILITY
3.1.
PRIMARY – provides the minimum service capabilities such as:
3.1.1. Routine Hematology (Complete Blood Count or CBC) – includes:
hemoglobin mass concentration, Erythrocyte Volume Fraction
(Hematocrit), Leucocytes Number Concentration (White Blood Cell
Count or WBC Count), Leucocytes Type Number Fraction (Differential
Count), Qualitative Platelet Determination
3.1.2.
3.1.3.
3.1.4.
3.1.5.
3.2.
Routine Urinalysis
Routine Fecalysis
Blood Typing – hospital based
Quantitative platelet determination – hospital based
SECONDARY – provide the minimum service capabilities of a primary
category and the following:
3.2.1. Routine Clinical Chemistry – includes: Blood Glucose Substance
Concentration (FBS), BUN - Blood Urea Nitrogen Concentration,
Blood Uric Acid Substance Concentration, Blood Creatinine
Concentration, Blood Total Cholesterol Concentration
3.2.2. Cross-matching (Compatibility Testing) – hospital based, Blood
Banking and Immunohematology
3.3.
TERTIARY – provides secondary service capabilities and the following:
3.3.1. Special Chemistry
3.3.2. Special Hematology
3.3.3. Immunology / Serology
3.3.4. Microbiology – Culture and Sensitivity Testing
Section 6. Policies
6.1. An approved permit to construct and design lay-out of a clinical laboratory shall
be secured from the BHFS prior to submission of an application for a Petition to
Operate.
6.2. No clinical laboratory shall be constructed unless plans have been approved and
construction permit issued by the BHFS.( Bureau of Health Facilities and Services)
6.3. A clinical laboratory shall operate with a valid license issued by BHFS/CHD
(Center for Health and Development), based on compliance with the minimum
licensing requirements (Annex A).
6.4. The clinical laboratory shall be organized and managed to provide effective and
efficient laboratory services.
6.5. 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
7.1. Application for Permit to Construct The following documents are required:
7.1.1. Letter of Application to the Director of BHFS
7.1.2. Four (4) sets of Site Development Plans and Floor Plans approved by
the architect and/or engineer.
7.1.3. DTI/SEC Registration (for private clinical laboratory)
7.2. Application for new license: A duly notarized application form. “Petition to
establish, Operate and Maintain a Clinical Laboratory” (Annex B), shall be filled
by the owner or his duly authorized representative at the BHFS.
7.3. Application for renewal of license:
A duly notarized application form, “Application For Renewal of License to
establish, Operate and Maintain A Clinical Laboratory” (Annex C), shall be filled
by the owner or his duly authorized representative at the respective CHD.
Application for renewal of license shall be filled within 90 days before the expiry
date of the license described as follows:
REGION
SCHEDULE OF APPLICATION FOR RENEWAL
OF LICENSE
NCR
Jan to March
1,2,3 & CAR
Feb to April
4,5,6
March to May
7,8,9
April to June
10,11,12, CARAGA & ARMM
May to July
7.4. Permit and License Fees:
7.4.1. 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.
7.4.2. A non-refundable fee shall be charged for application for renewal of
license to operate.
7.4.3. All fees shall be paid to the cashier of the BHFS/CHD.
7.4.4. All fees shall follow the current prescribed schedules of fees of the
DOH.
7.5. Penalties
7.5.1. A penalty of one thousand pesos (P 1,000) for late renewal shall be
charged in addition to the renewal fee for all categories if the application is filled
during the next two (2) months after expiry date.
7.5.2. An application received more than two (2) months after expiry date
shall be fined one hundred pesos (P100) for each month thereafter in addition to
the P 1,000 penalty.
7.6. Inspection
7.6.1. Each licensee shall make available to the Director of 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.
7.6.2. Each licensee shall make available to the Director of the BHFS/CHD or
his duly authorized representative(s) all pertinent records.
7.6.3. Clinical laboratories shall be inspected every two (2) years or as
necessary.
7.7. Monitoring
7.7.1. All clinical laboratories shall be monitored regularly and records
shall be made available to determine compliance with these rules and
regulations.
7.7.2. The Director of the BHFS/CHD or his authorized representative(s) shall
be allowed to monitor the clinical laboratory at any given time.
7.7.3. All clinical laboratories shall make available to the Director of the
BHFS or his duly authorized representative(s) records for monitoring.
7.8. Issuance of License
The license shall be issued by the Director of CHD or his authorized
representative, if the application is found to be meritorious.
7.9. Terms and Conditions of License
7.9.1. The license is granted upon compliance with licensing
requirements.
7.9.2. The license is non-transferable.
7.9.3. 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 actual transfer.
7.9.4. The laboratory in its new location shall be subject to re-inspection
and shall comply with the licensing requirements.
7.9.5. An extension laboratory shall have a separate license.
7.9.6. 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.
7.9.7. The clinical laboratory license must be placed in a conspicuous
location/area within a laboratory.
Section 8. Violations:
8.1. The license to operate a clinical laboratory shall be suspended or
revoked by the Secretary of Health upon violation of RA 4688 of the Rules and
Regulations issued in pursuance thereto:
8.2. The following acts committed by the Owner, President, Managers, Board
of Trustees/Director, Pathologist or its personnel are considered violations.
8.2.1. Operation of a clinical laboratory without a certified
pathologist or without a registered medical technologist.
8.2.2. Change of ownership, location, head of laboratory or
personnel without informing the BHFS and/or CHD.
8.2.3. Refusal to allow inspection of the clinical laboratory or
person(s) authorized by the BHFS during reasonable hours.
8.2.4. Gross Negligence.
8.2.5. Any act of omission detrimental to the public.
8.3. The Provincial, City and Municipal Health Offices 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.
9.1. If upon investigation, any person is found violating the provisions of RA
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.
9.2. Any person who operates a clinical laboratory without proper license
from the Department of Health shall upon conviction be subject to: Imprisonment
for not less than 1 month but not more than 1 year or ➢ a fine of not less than P
1,000 and not more than P 5,000 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.
9.3. 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.
9.4. The closure order issued by the DOH shall not be rendered ineffective
by any restraining order and injunction order issued by the court, tribunal or agency
or instrumentalities.
Section 10 Modification and Revocation of License
10.1. 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 any of the terms and conditions
and provisions of these rules and regulations.
10.2. No license shall 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 of List of Licensed Clinical Laboratories. A list of licensed
clinical laboratories shall be published annually in a newspaper of general circulation.
Section 13 Effectivity. These rules and regulations shall take effect 15 days after its
publication in the Official Gazette, 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:
I.
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
laboratories. The BHFS shall certify such training.
2. The Clinical Laboratory shall employ qualified and adequately trained
personnel. Work assignment shall be consistent with the qualification of the
concerned personnel.
2.1.
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 operation. For
hospital-based clinical laboratory, there shall be at least one
registered medical technologist per shift to cover the laboratory
operation
II.
3. There shall be staff development and appropriate continuing education
program available at all levels of organization to upgrade the knowledge,
attitudes and skills of staff.
PHYSICAL FACILITIES
1. The clinical laboratory shall be well-ventilated, adequately lighted, clean and
safe.
2. The working space shall be sufficient to accommodate its activities and allow
for smooth and coordinated work flow.
3. There shall be an adequate water supply.
4. The working space for all categories of clinical laboratories (both hospital and
non-hospital based)
shall have at least the following measurements:
Category
Primary
Secondary
Tertiary
III.
Space in sq m
10
20
60
to include separate, enclosed and adequately
ventilated room for Microbiology
EQUIPMENT AND INSTRUMENTS
1. There shall be provisions for sufficient number and types of appropriate
equipment/ instruments in order to undertake all the activities and laboratory
examinations. The equipment shall comply with safety requirements.
MINIMUM REQUIREMENTS FOR EQUIPMENTS/ INSTRUMENTS:
PRIMARY CATEGORY
Clinical centrifuge
Hemocytometer
Microhematocrit
Centrifuge
Microscope with oil
Immersion Objective
Hemoglobinometer or its
equivalent
Differential blood cell
counter or its equivalent
SECONDARY CATEGORY
All those in Primary
Category plus the following:
Refrigerator
Photometer or its equivalent
Water bath or its equivalent
Timer or its equivalent
TERTIARY CATEGORY
All those in the Secondary
Category plus the
following
Incubator
Balance, triple beam or
analytical balance
Rotator
Serofuge or its equivalent
Autoclave
Drying oven
Biosafety cabinet or its
equivalent
2. For other laboratory examinations being performed, the appropriate
equipment necessary for performing such procedures shall be made
available.
IV.
GLASSWARES/ REAGENTS/ SUPPLIES
All categories of clinical laboratories shall provide adequate and
appropriate glass wares, 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
1.1.
There shall be a documented, continuous competency assessment
program for all laboratory personnel.
1.2.
The program shall provide appropriate and standard laboratory
methods, reagents supplies and equipment.
1.3.
There shall be a program for the proper maintenance and monitoring
of all equipment.
1.4.
The program shall provide for the use of quality control reference
materials.
2. External Quality Control Program
2.1.
2.2.
2.3.
VII.
All clinical laboratories shall participate in an External Quality
Assurance Program given by designated National Reference
Laboratories and/or other recognized reference laboratories.
A satisfactory performance rating given by a National Reference
Laboratories shall be one of the criteria for the renewal of license.
Any refusal to participate in an External Quality Assurance Program
given by the designated National Reference Laboratories shall be one
of the basis for suspension / revocation of the license of the
laboratory.
REPORTING
Laboratory requests shall be construed as consultation between the
requesting physician and the pathologist of the laboratory and as such laboratory
results shall be released accordingly.
1. All laboratory reports on various examinations of specimens shall bear the
name of the registered medical technologist and the pathologist and duly
signed by both.
2. No person in the clinical laboratory shall issue a report, orally or in writing,
whole or portions, thereof without a directive from the pathologist or his
authorized associate to the requesting physician or his authorized
representative except in emergency cases when the results may be released
as authorized by the pathologist.
VIII.
RECORDING
There shall be a system of accurate recording to ensure quality results.
1. There shall be an adequate and effective system of recording requests and
reports of all specimens submitted and examined.
2. There shall be provisions for filing, storage and accession of all reports.
3. All laboratory records shall be kept on file for at least one (1) year.
3.1.
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 a laboratory
examination shall be at the prevailing rates.
1. The rates shall be within the range of the usual fees prevailing at the time and
the particular place, taking into consideration the cost of testing and quality
control of various laboratory procedures.
2. Professional services rendered to the patient in the performance of special
procedures or examinations shall be charged separately and not included in
the laboratory fee/s.
3. What are the different sections of a clinical laboratory?
The organization of a particular clinical laboratory depends on its size, the number of
tests done, and the facilities available. Larger laboratories tend to be departmentalized;
there is a separate area designated for each of the various divisions. The current trend is
to have a more “open” design or a core lab where personnel can work in any of several
areas or divisions.
A. Clinical Chemistry
The clinical chemistry laboratory performs quantitative analytical procedures
on a variety of body fluids, but primarily on serum or plasma that has been
processed from whole blood collected from the patient. Tests are also done on urine
or, less frequently, on body fluids. Several hundred analytes can be tested in the
chemistry laboratory, but a few tests are used much more often to assist in the
diagnosis of disease.
One of the most commonly performed chemistry tests is blood glucose. Other
frequently performed assays are cholesterol, electrolytes, and serum proteins. Blood
glucose tests are used to diagnose and monitor diabetes mellitus. Cholesterol is a
test that is part of a battery of tests to monitor the patient’s lipid status. Electrolytes
affect many of the metabolic processes in the body, including maintenance of
osmotic pressure and water distribution in various body compartments, maintenance
of pH, regulation of the functioning of heart and other muscles, and oxidationreduction processes. Elevated serum protein levels can indicate disease states of
several types. Serum enzyme tests are done to identify dam- age to or disease of
specific organs, such as heart muscle damage or liver cell damage. Tests to monitor
drug therapy and drug levels, or toxicology, are also performed in chemistry
laboratories.
Most routine chemistry testing is done by automated methods using
computerized instruments that are sophisticated and rapid and provide reliable
results. Persons working in chemistry laboratories will be using automated analytical
equipment; having a good working knowledge of the various types of methodologies
and instrumentation used is essential.
B. Microbiology
In the microbiology laboratory, microorganisms that cause disease are identified;
these are known as pathogens. Generally, the common bacteria, viruses, fungi,
and parasites are identified in a typical clinical laboratory. Specimens sent to the
microbiology laboratory for culture include swabs from the throat or wounds, sputum,
vaginal excretions, urine, and blood. It is important that the microbiology staff be able
to differentiate normal biota or normal flora—organisms that are usually present at
specific sites in the body—from pathogenic flora.
Various differential testing is done, from inoculation and incubation of the classic
culture plate, to observation of a microorganism’s growth characteristics, to the use
of Gram-staining techniques to separate gram-positive from gram-negative
organisms. Once a pathogen is suspected, more testing is done to confirm its
identity.
Another task for the microbiology laboratory is to identify effective antibiotics for
treatment of an offending pathogen. A pure culture of a potential pathogen is tested
by using a panel of antibiotics of various types and dosages to determine the
susceptibility of the organism to these antibiotics. With this information, the primary
care provider can choose the most effective antibiotic based on in vitro laboratory
testing.
C. HEMATOLOGY AND COAGULATION STUDIES
Hematology is the study of blood. The formed elements of the blood, or blood
cells, include erythrocytes (red blood cells [RBCs]), leukocytes (white blood cells
[WBCs]), and thrombocytes (platelets).
The routine hematology screening test for abnormalities in the blood is the
complete blood cell count (CBC). Most CBCs include RBC count, WBC count,
platelet count, hemoglobin concentration, hematocrit, and a percentage differential of
the WBCs present. The results of the CBC are useful in diagnosing anemias, in
which there are too few RBCs or too little hemoglobin; in leukemias, in which there
are too many WBCs or abnormal WBCs; and in infectious processes of several
etiologies, in which changes in WBCs are noted. These tests are done in most
hematology laboratories by use of an automated instrument. Many of these
automated cell counters also provide automated WBC differential analyses,
separating the types of WBCs present by size, maturity, and nuclear and cytoplasmic
characteristics.
Other tests done in hematology laboratories are reticulocyte counts and
erythrocyte sedimentation rate (ESR) measurements. Examination of bone marrow is
done in special hematology divisions where trained hematopathologists and
technologists are present to examine the slides. The bone marrow from a patient is
obtained by a trained physician.
Work done in the hemostasis and coagulation laboratory assesses bleeding and
clotting problems. The two tests most often performed in the coagulation laboratory
are prothrombin time (PT) and activated partial thromboplastin time (APTT). These
tests can be used to identify potential bleeding disorders and to monitor
anticoagulant therapy. Patients who have had a heart attack or stroke, both caused
by formation of blood clots, are given medications that anticoagulate their blood or
slow the clotting process. These patients must be monitored because too large a
dose of these drugs can lead to bleeding problems.
D. CLINICAL MICROSCOPY
There are two major areas in clinical microscopy it includes the urinalysis
laboratory division, the routine urine screening tests are done. Historically, the
routine urinalysis was one of the earliest laboratory tests performed, and it still
provides valuable information for the detection of disease related to the kidney and
urinary tract. By evaluating the results of the three component parts of the
urinalysis—observation of the physical characteristics of the urine specimen itself
(e.g., color, clarity, specific gravity), screening for chemical constituents (e.g., pH,
glucose, ketone bodies, protein, blood, bilirubin, urobilinogen, nitrites, leukocyte
esterase), and microscopic examination of the urinary sediment— metabolic
diseases such as diabetes mellitus, kidney disease, and infectious diseases of the
urinary bladder or kidney can be diagnosed and monitored.
Second is the Fecalysis section where analysis of stool or fecal specimen is done
for the detection and examination of parasitic worms and ova and other special
examination such as the occult blood test.
E. BLOOD BANK/ IMMUNOHEMATOLOGY
When blood is donated for transfusion purposes, it must undergo a rigorous
protocol of testing to make certain it is safe for transfusion.
Proper sample identification is particularly crucial in blood-banking procedures,
because a mislabeled specimen could result in a severe transfusion reaction or even
death for the recipient.
Most of the testing done in the blood bank laboratory is based on antigenantibody reactions. In the specialized tests performed in the blood bank laboratory,
anti- gens are specific proteins attached to red or white blood cells. The nature of
specific antigens determines the blood group assigned: A, B, O, or AB. Rh typing is
also done, with blood being classified as Rh positive or Rh negative.
Donated blood is also screened for any unusual antibodies present and for the
presence of antibodies associated with blood-borne infectious diseases such as
hepatitis viruses or human immunodeficiency virus (HIV). The donor blood must be
matched to the prospective recipient’s to ensure that they are compatible. When a
blood transfusion is ordered, it is extremely important that only properly matched
blood be transfused.
Blood banks also practice transfusion medicine using components of blood or
blood products. A patient does not usually need the whole unit of blood, only a
particular part of it, such as the RBCs, platelets, or specific clotting factors. By using
blood component therapy, one unit of donated blood can help several different
patients who have different needs. The blood bank technologist separates the
donated unit into components and stores them for transfusion at a later time.
F. IMMUNOLOGY AND SEROLOGY
The normal immune system functions to protect the body from foreign
microorganisms that may invade it. When foreign material—that is, something the
body does not already have as part of itself—enters the body, the immune system
works to eliminate the foreign material, which can be bacteria, viruses, fungi, or
parasites. The body’s defensive action is carried out by its WBCs— lymphocytes,
monocytes, and other cells—through which the invading organism is eliminated or
con- trolled.
As in the blood bank laboratory, many of the immunology/serology laboratory’s
procedures are based on antigen-antibody reactions. When foreign material
(antigen) is introduced into the body, the body reacts by means of its immune system
to make antibodies to the foreign antigen. The antibodies formed can be measured in
the laboratory.
In the evaluation of certain infectious diseases, the detection of antibodies in the
serum of the patient is an important step in making and confirming a diagnosis and
managing the illness. The usefulness of serologic testing is based on the rise and fall
of specific antibody titers in response to the disease process. In many cases,
serologic testing is done retrospectively because the disease must progress to a
certain point before the antibody titers will rise; often it takes several days or weeks
for the antibody titer to rise after the first symptoms appear.
In general, serologic testing is most useful for infectious organisms that are
difficult to culture, cause chronic conditions, or have prolonged incubation periods.
In addition to its value in the diagnosis of infectious disease, immunologic testing
performed in a dedicated immunology laboratory or immunoassays performed in
clinical chemistry departments can identify normal and abnormal levels of immune
cells and serum components. Immune cellular function can also be determined
G. ANATOMIC PATHOLOGY – SECTION OF HISTOPATHOLOGY/ CYTOLOGY
Histopathology (or histology) involves the examination of sampled whole tissues
under the microscope. Three main types of specimen are received by the pathology
laboratory.
Specimens received by the pathology laboratory require tissue preparation then are
treated and analyzed using techniques appropriate to the type of tissue and the
investigation required. For immediate diagnosis during a surgical procedure a frozen
section is performed
1. Larger specimens include whole organs or parts thereof, which are removed
during surgical operations. Examples include a uterus after a hysterectomy,
the large bowel after a colectomy or tonsils after a tonsillectomy.
2. Pieces of tissue rather than whole organs are removed as biopsies, which
often require smaller surgical procedures that can be performed whilst the
patient is still awake but sedated. Biopsies include excision biopsies, in which
tissue is removed with a scalpel (e.g. a skin excision for a suspicious mole) or
a core biopsy, in which a needle is inserted into a suspicious mass to remove
a slither or core of tissue that can be examined under the microscope (e.g. to
investigate a breast lump).
3. Fluid and very small pieces of tissue (individual cells rather than groups of
cells, e.g. within fluid from around the lung) can be obtained via a fine needle
aspiration (FNA). This is performed using a thinner needle than that used in a
core biopsy, but with a similar technique. This type of material is usually liquid
rather than solid, and is submitted for cytology rather than histology
(see Cytopathology).
Specimens received by the pathology laboratory require initial tissue preparation,
then are treated and analyzed using techniques appropriate to the type of tissue and
the investigation required.
For immediate diagnosis during a surgical procedure, which may influence the
type of surgery being performed, a frozen section is done.
H. SPECIALIZED SECTIONS OF THE LABORATORY
IMMUNOHISTOCHEMISTRY
Combines anatomical, clinical and biochemical techniques where antibodies
(monoclonal and polyclonal) bounded to enzymes and fluorescent dyes are used to
detect presence of antigen in tissue that is eseful for diagnosing some types of
cancer.
MOLECULAR BIOLOGY AND BIOTECHNOLOGY
Biotechnology is a fast-growing discipline of the diagnostic laboratory. Molecular
biology, or the discipline of molecular diagnostics, uses this technology. Molecular
pathology applies the principles of basic molecular biology to the study of human
diseases.
New approaches to human disease assessment are being developed by clinical
laboratories because of the new information about the molecular basis of disease
processes in general. Traditional laboratory analyses give results based on a
description of events currently occurring in the patient (e.g., blood cell counts,
infectious processes, blood glucose concentration). But molecular biology introduces
a predictive component: findings from these tests can be used to anticipate events
that may occur in the future, when patients may be at risk for a particular disease or
condition.
More than ever, this predictive component reinforces the importance of how
laboratory test results are used and emphasizes ethical considerations and the need
for genetic counseling.
4.
What is the laboratory testing cycle?
The “laboratory testing cycle” consists of all steps between the time when a
clinician thinks about and orders a laboratory test and the time the appropriate patient’s
sample for testing is obtained and the results of the testing are returned to the clinician
(often called the “vein-to-brain” turnaround time [TAT] of test results). This cycle consists
of 3 phases: pre-analytic, analytic, and post-analytic.
The pre-analytic testing phase occurs first in the laboratory process. This phase
may include specimen handling issues that occur even prior to the time the specimen is
received in the laboratory. Important errors can occur during the pre-analytic phase with
specimen handling and identification. Therefore, the pre-analytical phase must have
rigorous control measures to avoid unwittingly allowing problems or errors to travel
further "downstream."
The second phase is the analytic phases. This phase includes what is usually
considered the "actual" laboratory testing or the diagnostic procedures, processes, and
products that ultimately provide results.
The post-analytic phase is the final phase of the laboratory process. This phase
culminates in the production of a final value, result, or in the case of histology, a
diagnostic pathology report.
The results of a relatively recent article on the sources of laboratory errors,has
shown that analytical sources of error occurred least frequently (15%) while preanalytical
errors occurred most frequently (62%).
The top 5 causes of preanalytical errors were:
o
o
o
o
o
Specimen collection tube not filled properly.
Patient ID error
Inappropriate specimen collection tube/container.
Test request error
Empty collection tube
LABORATORY TESTING CYCLE
5.
What is Quality Assurance
Simply, Quality assurance (QA) encompasses all activities performed by the
laboratory personnel to ensure reliability of test results. It is an organized, systematic,
well-planed and regularly done with the results properly documented and consistently
reviewed. There are two major components of QA
i.
ii.
Internal Quality Assurance System (IQAS) which is the day-to-day activities
that are undertaken in order to control factors or variables that may affect the test
results
External Quality Assurance System (EQAS) which is a system for checking
performance among clinical laboratories and is facilitated by designated external
agencies. The National Reference Laboratories (NRL) is the DOH-designated
EQAS
Designated NRL-EQAS:
LESSON VII
ETHICS
I.
Introduction
Ethics emphasizes the responsibility and capability of an individual to come up with
conclusions through reasoning, and to determine which principles are relevant in a particular
case. Ethics are well-founded standards of right and wrong that prescribe what humans
ought to do, usually in terms of rights, obligations, fairness, or specific virtues. Further, it is
the reasonable obligation for an individual to refrain from hurting others, and sometimes an
obligation to help others.
II.
Objectives
At the end of the learning session, the student must be able to:
III.
Discuss the difference of ethics and morale
o
Distinguish comprehensively the ethical principle
o
Dissect the Anatomy of ethical dillema
o
Discuss intensively the professional ethics
Lesson Outline
1.
2.
3.
4.
5.
6.
7.
IV.
o
Ethics and Morale
Laws and Ethics
Bioethics
Ethical Principles
Ethical Philosophies
Anatomy of Ethical Dilemma
Ethics and the Medical Professional
Lesson
1. Ethics and Morale
Morals and ethics are terms that are sometimes used interchangeably because
they are based on values regarding human conduct. However, there are some subtle
differences.
Morals are deeply held personal beliefs about what constitutes right or wrong
behavior. Such beliefs stem from a variety of sources, including religion, family customs,
culture, and past experiences.
Ethics goes further than a simple pronouncement of moral judgment and
involves thoughtful analysis, commonly at a philosophical level. Ethics evaluates human
behavior in light of specific ethical principles and looks at the impact of such behavior on
individuals and society as a whole. Stated more simply, when one is behaving ethically,
one is concerned with the big picture as well as the immediate situaion.
2. Laws and Ethics
A behavior may be deemed unethical by some individuals, it is not necessarily
illegal. Conversely, a behavior that has been designated as illegal is not necessarily
considered unethical by all. All cultures have beliefs about what is considered right and
wrong behavior. Actions that are considered most harmful or offensive by the majority
may be designated as illegal. Individuals who commit such acts, if caught, will be subject
to some form of fine or punishment.
3. Bioethics
Biomedical ethics, or bioethics, is a specialized branch of ethics that concerns
itself with human behavior within the context of modern medicine. In recent years,
modern science has provided humankind with an amazing number of new treatment
options .
The explosion of medical research has necessarily compounded the complexity
of decision making required of patients and family members. In many situations, the
“right” choice is not readily apparent, leaving everyone to agonize and, perhaps,
disagree about what ought to be done in any given situation.
The number and variety of situations that confront health care providers are
infinite. Therefore, it is not possible to predict them or to explain what ought to be done
in each and every case. So what are health care workers to do? At worst, they can keep
their heads in the sand, refusing to discuss and deal with these difficult and painful
topics. Doing so tends to result in responses dictated by fear and prejudice when touchy
topics arise and difficult decisions must be made, which is not helpful to anyone.
A far better plan is for health care workers to become educated and prepared
with information and tools that can help them navigate these difficult waters and provide
better guidance to their patients. These tools include an understanding of key ethical
principles, ethical philosophies, and a thoughtful plan for responding to ethical dilemmas
when they arise.
4. Ethical Principles
Ethical principles are rules about how people ought to behave. An understanding
of these principles is necessary to understand the ethical reasoning process. Upon initial
examination, ethical principles may seem simple and straightforward. However, they
commonly come into conflict with one another, sometimes creating complicated
situations. Some of the most common ethical principles applied to health care include:
a) Nonmaleficence refers to the duty of health care providers to “do no harm.” This
principle was first mentioned in the Hippocratic oath and has since been
repeated in one form or another in various professional ethical codes. Few would
argue the merit of such a principle. However, the reality of most forms of medical
treatment is that there is always the potential for harm. Even something as
simple as prescribing an antibiotic to a patient with an infection has some
potential to cause harm.
b) The principle of beneficence goes a step beyond nonmaleficence. It states that
health care providers must aim to provide benefit for their clients in addition to
avoiding doing harm. This principle has served to guide some of the changes that
have occurred over the past century regarding the regulation of medications.
Years ago, virtually anyone could sell their own version of a remedy, sometimes
called “snake oil,” wherever and to whomever they wished. They could make
unsubstantiated claims about its curative powers. In most cases, these
“remedies” provided no benefit and, worse yet, were sometimes harmful. Since
that time, laws have been enacted
With beneficence in mind, physicians are obligated to provide
medications and treatments that have a reasonable likelihood of helping patients.
As a patient faces a decision regarding possible surgery, a diagnostic procedure,
or a new medication, the physician must provide information regarding potential
risks and benefits. In every case, there is some element of risk, because no
procedures or medications are totally risk free. In this decision-making process,
the health care provider and patient strive to make a choice that minimizes
potential harm (nonmaleficence) while maximizing potential benefit
(beneficence).
c) The principle of autonomy refers to the right of individuals to self-determination.
This principle includes the notion of freedom of choice that is so highly valued.
The right to autonomy allows people to make choices about lifestyle, work,
education, and many other issues, such as religion, political affiliation, marriage,
and more.
Autonomy also includes the right to choose or reject forms of health care
treatment. Respecting a patient’s right to autonomy means that the physician and
other health care workers must enable the patient to make informed choices. For
invasive and otherwise risky treatments, health care providers must, therefore,
obtain consent (agreement or permission) from patients.
d) The principle of distributive justice comes from the broader principle of justice.
The principle of justice is founded on the concept of fairness. The principle of
distributive justice then concerns itself with the fair allocation, or distribution, of
scarce resources. This principle is especially relevant in the realm of health care,
where resources are always scarce. For example, there is a chronic need for
transplantable organs, which raises the difficult question of how fair decisions
might be made about who receives a transplant and who does not. Furthermore,
such difficult decisions must be made to maximize good (beneficence) for the
greatest number of people, while minimizing harm (nonmaleficence) to all.
e) Paternalism may arise in situations where the ethical principles of autonomy and
beneficence are in conflict with one another. In this setting, a dominant “paternal”
role is taken by a health care provider, judge, or other person or entity who
makes a decision for the good of another person, possibly against that person’s
wishes. In doing so, the person’s right to autonomy is denied. For example, a
parent is allowed to give consent for the medical treatment of her child who is a
minor, or an adult is the surrogate decision maker for an elderly parent who has
been deemed incapable of making her own decisions because of dementia.
f) The principle of veracity refers to the quality of truthfulness. This simple principle
is generally understood and valued by most individuals, although it is not always
an easy one to follow. For example, a physician may need to find a kind but
honest way to tell a patient that she has cancer, or the office manager must find
a tactful way to talk with an employee about her unacceptable behavior. On the
other hand, there may be times when complete honesty is not needed or even
appropriate to the situation. Consider the following questions: What should a
medical technologist say if a patient asks her for the results of laboratory test?
Knowing that such information should only be relayed by the physician, how
should the medical technologist respond?
g) The principle of fidelity refers to faithfulness, the duty to keep reasonable
promises and meet obligations. An example of reasonable expectations includes
the patient’s right to expect health care providers to respect privacy and maintain
confidentiality. A patient also has the right to expect that health care providers
will do what they say they will do (keep promises).
5. Ethical Philosophies
All people operate from the foundation of one or a combination of ethical
philosophies, whether or not they are aware of it. Understanding ethical philosophies
and identifying which one feels most “true” helps individuals understand why they view
issues as they do and why they may seem unable to understand others who have
opposing viewpoints. Under- standing ethical philosophies also helps a person
understand why she analyzes ethical dilemmas as she does. Two of the most common
types of ethical philosophies are deontological and teleological.
a) Deontological philosophies operate from the belief that all human beings are of
equal worth. This type of philosophy focuses on individual behaviors, rights, and
duties. According to deontological philosophies, ethical principles are absolute and
exceptions are rarely, if ever, justified. Thus, some actions are considered
intrinsically immoral or wrong, regardless of any good or useful consequences that
might result from them. For example, a person who believes it is wrong to kill and
views that doctrine in a deontological way will not tolerate exceptions to that rule. So,
for example, if a person adheres to this doctrine, he may be opposed to capital
punishment, military action, and abortion because each of these can be considered a
mode of killing. A person with such a deontological view believes that violating the
doctrine in any way will cause greater harm to humanity than any immediate harm
that may be caused by adhering to it.
On the other hand, some persons may use their deontological perspective to
override their usual beliefs about appropriate behavior. For example, they may feel a
great obligation to serve their country by joining the military, regardless of their
feelings about killing others, or may feel compelled to commit a crime, such as
bombing an abortion clinic.
b) Teleological philosophies focus more on the consequences of actions, rather than
actions themselves. Utilitarianism is one of the most common teleological
philosophies. The name of this philosophy is taken from the idea of utility or
usefulness. Developed by two English philosophers, Jeremy Bentham and John
Stuart Mill, this philosophy interprets the rightness or wrongness of actions according
to their consequences. Similar to deontology, utilitarianism also values duty and
obligation and regards all human beings of equal value. However, utilitarianism rarely
views particular issues or behaviors as strictly right or wrong; rather, it allows for
ambiguity, or a state of uncertainty or vagueness.
This emphasis on the “shades of gray” in a particular issue steers a person to
consider the consequences or end result of an action as an integral component in
determining its ethical rightness. Examining the end result, then, demands that the
needs of many people supersede the needs of a few, and values highly the greater
good for humankind as a whole. For example, a person who adheres to utilitarianism
may believe that a pregnant woman’s right to autonomy supersedes whatever rights
her unborn fetus may have. For the legal system to rob the woman of her autonomy,
even temporarily, may be viewed by some as a greater harm to her and to society as
well, for in this country the right to self-determination (autonomy) is prized above
nearly everything else.
No one ethical philosophy is right or wrong. Each person operates from a
philosophical foundation consistent with her own religious beliefs, personal values, and life
experiences. Individual actions may be supported or rejected by others based on their
different philosophical foundation. If two persons are operating from different ethical
philosophies, they may never agree on issues as controversial as abortion or capital
punishment and will probably never understand one another’s viewpoints. Sadly, without
such understanding social debate commonly deteriorates into name-calling and other
unproductive argumentation.
Learning about ethical philosophies such as utilitarianism and deontology promotes
understanding of why people tend to disagree so heatedly about some issues and may
further explain why some social debates never see resolution. Regardless of the ethical
philosophy used and the specific decisions made, some situations have the potential for profound, long-term consequences.
6. Anatomy of Ethical Dilemma
In many cases, what first seems to be an ethical dilemma is really just a situation in
which miscommunication has occurred or inadequate information is available. Therefore,
the first steps in addressing a potential ethical dilemma are to gather data and seek
clarification of all relevant issues. Interested parties must put emotion aside long enough
to really communicate and gather the data. When they do so, they are generally able to
agree about a course of action. However, if parties are in perpetual disagreement, a true
ethical dilemma may exist. How can anyone know for sure? The defining criteria of an
ethical dilemma include:
1. A decision must be made.
2. The outcome will have profound consequences.
3. There is disagreement among involved parties about the right course of action.
a) Ethical Decision Making: In the case of a true ethical dilemma, decision making
may be extremely difficult. So how is a reasonable decision finally achieved?
Unfortunately, in most cases, a person responds based on emotion and personal
beliefs, rather than careful reflection. Sometimes a person’s response is based on a
previous experience that has little bearing on the current situation. Making such
judgments is known as bias. Sadly, this type of response commonly leads to conflict.
On the other hand, thoughtful decision making based on a solid understanding of
ethical principles and careful reasoning, called the ethical reasoning process, will
generally lead to consensus among key parties and result in sound decisions. A
person must learn this type of decision making; it does not come naturally to most
people.
When people follow this process, they are able to think their way through a
situation systematically, considering all relevant issues and arriving at a thoughtful
conclusion. Use of the ethical reasoning process does not guarantee an easy
resolution to any problem. However, careful, thoughtful reasoning supports decision
makers in making the best decision possible under difficult circumstances.
b) Ethics Committee: An ethics committee serves several functions within a health
care organization and the larger community. Such a committee usually helps
formulate institutional policies and provides education for health care staff and,
possibly, community members. Such education can aid staff members in putting
aside personal bias in order to support clients and families most effectively as they
navigate difficult situations.
An ethics committee serves a consultative role as well. For example,
disagreement between family members and health care providers on decisions
regarding patient care is common. A member of an ethics committee may act as a
guide for interested parties and help them through the decision-making process.
Alternatively, the entire committee may meet to conduct a more formal analysis
of a case. Recommendations from the committee are not legally binding but can be
helpful to staff who are in conflict and to family members who are paralyzed by
confusion, grief, or guilt.
7. Ethics and the Medical Professional
A solid understanding of health care ethics can help a medical assistant in several
ways. It can help her identify and clarify her own personal values, behave in a manner
consistent with the values of her profession, and respond to situations in the medical
office in a thoughtful, consistent manner.
Code of Ethics
All health care providers, including medical technologists, must demonstrate
behavior that is legal and ethical. The medical technologist should have an
understanding of ethical principles and be familiar with codes of ethics that pertain to her
profession. The PAMET has adopted a code of ethics that embodies the core values
agreed upon by the members of the profession and sets the standards for personal and
professional conduct.
Ethical Behavior in the Medical Office
Medical technologists are obligated to behave professionally and ethically in their
working institution. They must act and respond to all situations in a manner consistent
with their own professional code of ethics and with the expectations of their employer. A
medical technologist will fulfill this obligation easily if the professional takes the time to
clarify its own values and seeks understanding regarding health care ethics. Issues of
importance in the clinical setting are the same as those touched on in the Medical
Technology Code of Ethics, including trust and loyalty, confidentiality, respect and
dignity, and commitment to professional development.
Trust and Loyalty
A person rarely grants another trust automatically. Usually, a person earns the
trust of another through behaving in a trustworthy manner, such as by demonstrating
loyalty and commitment to high-quality work. A medical technologist should seek to earn
the trust of her employer and the physicians and others with whom she works as well as
her patients. A medical technologist who is dependable in attendance, punctuality, and
work effort as well as respectful in behavior toward others will quickly earn the trust of
most people. Further trust is developed as a medical technologist if the professional can
be trusted with sensitive information and increasing responsibility.
Confidentiality
The importance of confidentiality in health care is a common theme, because a
medical technologist has no more important duty than to protect her patient’s privacy,
keeping all information confidential. When tempted to share personal health care
information about a patient with another party, a professional must always ask these
questions first:





Is this party a health care professional directly involved in this patient’s care?
Has legal documentation been provided that grants this party legal access to this
information?
How would the patient feel about me sharing this information with this party?
Will my sharing of this information benefit or harm this patient?
If I were in this patient’s shoes, how would I feel about my personal health
information being shared in this way and with this party?
Respect and Dignity
Few persons would argue against being treated with respect and dignity, and
most would agree that treating others with respect and dignity is desirable. Why, then,
does disrespectful behavior seem to be so prevalent? Because humans are emotional
beings, they commonly act and react based on how they are feeling at the moment
without carefully considering the potential ramifications of their actions. As a result, their
words may be poorly chosen, their behaviors may be interpreted by others as offensive,
and the emotions they are feeling may cause them to communicate in an overly
aggressive manner.
Commitment to Professional Development
A hallmark of a true professional is the commitment to lifelong learning. Nowhere
is this commitment more important than in the health care field, where the knowledge
base changes rapidly, seemingly on a daily basis. A medical technologist must make a
commitment to continue her education in some fashion for the duration of her career.
Opportunities for continued education are numerous. For example, a medical
technologist committed to professional development can attend in-house educational
offerings at work; take formal graduate studies; attend regional, or national medical
assistant conferences; read m health care journals; and study topics of interest.
V.
Summary
o
Morals and ethics are based on values regarding human conduct. Morals are deeply
held personal beliefs about what constitutes right or wrong behavior. Ethics involve
thoughtful analysis and evaluate human behavior in light of specific ethical principles
and look at the impact of such behavior on individuals and society as a whole.
o
Although a behavior may be deemed unethical by some individuals, it is not
necessarily illegal. Conversely, a behavior that has been designated as illegal is not
necessarily considered unethical by all.
o
Bioethics is a specialized branch of ethics that concerns itself with human behavior
within the context of modern medicine. The number and variety of situations that
con- front health care providers are limitless. Therefore, health care providers should
become educated and be prepared with information and tools that can help them
navigate these difficult waters and provide better guidance to their patients.
o
Ethical principles are rules about how people ought to behave. Common ethical
principles include nonmaleficence, beneficence, autonomy, distributive justice,
paternalism, veracity, and fidelity.
o
Understanding ethical philosophies and identifying which one feels most “true” to
them helps individuals understand why they view issues as they do and why they
may seem unable to understand others who have opposing viewpoints. The two key
ethical philosophies include deontology and utilitarianism. Knowledge of these
philosophies helps promote understanding about why people tend to disagree so
heatedly about some issues and may further explain why some social debates seem
never to be resolved.
o
The defining criteria of an ethical dilemma include the need for a decision, an
outcome with profound consequence, and disagreement among interested parties.
o
In the case of a true ethical dilemma, decision making may be extremely difficult.
However, thoughtful decision making based on a solid understanding of ethical
principles and careful reasoning will generally lead to consensus among key parties
and result in sound decisions.
VI.
o
The ethical reasoning process includes problem clarification, data gathering,
identification of relevant ethical principles, brainstorming, identification of options,
negotiation of a course of action, and evaluation.
o
An ethics committee serves as a resource within the health care organization and the
larger community. It helps formulate institutional policies, provides education, and
may serve as a consultant when a difficult decision must be made.
o
A solid understanding of health care ethics can help a medical assistant identify and
clarify her own personal values, behave in a manner consistent with the values of her
profession, and respond to situations in the medical office in a thoughtful, consistent
manner.
o
All health care providers, including medical technologists, must demonstrate
behavior that is legal and ethical. The medical assistant should have an
understanding of ethical principles and be familiar with codes of ethics that pertain to
her profession.
Lesson Activities/ Testing
Divide into teams of three to five students. Read the following scenario with the
members of your team. Then discuss the ethical issues involved, according to the guidelines
that follow the scenario.
Madge is an 82-year-old female who lies in a coma on life support. She was admitted to
the hospital two weeks ago after falling, hitting her head, and suffering a severe intracranial
bleed. Initially, her family urged health care providers to do everything possible to keep
Madge alive.
They stressed that she had recently been living independently in her own home and was
an avid gardener. They were hopeful that she could return to a similar quality of life. After
many tests and procedures and minimal improvement in Madge’s’ condition, the family now
faces a heart-wrenching decision.
Should they continue to push for aggressive care, knowing that the prognosis is poor yet
hoping for the chance of a miracle? Or should they make the difficult decision to withdraw all
aggressive forms of care, provide comfort measures only, and “allow nature to take its
course”?
1. Discuss this scenario and reach a consensus among team members about what
recommendation you think should be made in this case.
2. Now picture in place of Madge your own mother or child. Does the choice still seem
as simple? Discuss your thoughts and feelings with your teammates.
3. Now consider the same scenario with the following changes:
 Madge is now a 4-year-old, little girl.
 Madge is now a 32-year-old widowed nurse with four young children at home.




VII.
References
Madge is now a 57-year-old woman who is an alcoholic, has no family, and is
on public assistance.
Madge is now Miguel, a 33-year-old, unmarried man who does seasonal work.
Madge is now Michael, a 45-year-old white male who is a stockbroker with
good insurance and a wife and two teenagers at home.
Madge is now Marvin, a 33-year-old artist who has been diagnosed with HIV
and is openly gay.
LESSON VIII
Medical Terminologies and Abbreviation
I.
Introduction
Medical terms are used every day in medical offices, newspapers, television, and
conversational settings. Most of us are familiar with many medical terms; however, other medical
terms seem complicated and foreign. Learning and understanding how medical terminology
developed can help us understand these terms.
Current medical vocabulary is based on terms of Greek and Latin origin, eponyms (words
formed from a person’s name), and modern language terms. The majority of medical terms are
derived from word parts based on Greek and Latin words. Becoming familiar with these Greek
and Latin terms and identifying word parts will enable one to learn common medical terms and
to recognize unfamiliar medical terms by word analysis. Medical terminology may seem daunting
at first because of the length of medical words and seemingly complex spelling rules, but once you
learn the basic rules of breaking a word down into its constituents the words become easier to
read and understand.
II.
Objectives
At the end of the learning session, the student must be able to:
III.
o
Identify the meaning of the root word, prefixes and suffixes commonly used in medical
terminologies
o
Practice correctly the use of commonly used prefixes and suffixes
o
Construct sentences using appropriate suffixes and prefixes;
o
Define the meaning of common medical terms used in the practice of medical
technology.
o
Transcribed common abbreviations used in clinical laboratory practice
Lesson Outline
A. Medical
1.
2.
3.
4.
5.
Terminologies
Root word
Prefixes
Suffixes
Medical Terms
Plural Forms
B. Abbreviations
1. Abbreviations used in the medical technology practice
IV.
Lesson
A. Medical Terminologies
Many medical terms are composed of word part combinations. Recognizing these word
parts and their meanings simplifies learning medical terminology. These word parts are
1.
o
prefix: word part found at the beginning of a word. Usually indicates number,
location, time, or status.
o
root: word part that gives the essential meaning of the word.
o
combining vowel: single vowel, usually an “o,” that is added to the end of a root to
make the word easier to pronounce.
o
combining form: combination of the root and combining vowel.
o
suffix: word part found at the end of a word. Usually indicates procedure, condition,
disease, or disorder. Understanding the meaning of the word parts allows one to
dissect medical terms in a logical way. By breaking down unfamiliar terms into
recognizable word parts, one’s medical vocabulary can be greatly increased.
Prefixes: added to the beginning of a word or root to modify its meaning. For example,
the term operative can be modified using various prefixes.



The prefix pre- means before. Preoperative means before or preceding an
operation.
The prefix peri- (pehr-e) means around. Perioperative means pertaining to the
period around an operation or the period before, during, and after an operation.
The prefix post- means after. Postoperative means after an operation.
Without a prefix the root traumatic
means pertaining to injury.
Without a prefix the root uria means
urination.
ab- (ahb) means away from.
abduction means to take away from
midline.
Without a prefix the root emetic means
pertaining to
vomiting
a- (ah or ̄a) means without or no.
atraumatic means without injury
an- (ahn) means without or no.
anuria means absence of urine.
ad- (ahd) means toward.
adduction means move toward the
midline.
anti- (ahn-t ̄ı or ahn-tih) means against.
antiemetics work against or prevent
vomiting.
dys- (dihs) means difficult, painful, or
bad. dysphagia means difficulty eating
or swallowing.
eu- (yoo) means good, easy, or normal.
euthyroid means having a normally
functioning thyroid gland.
2.
endo- (ehn-do ̄) means within or inside.
endocrine means to secrete internally.
ex- (ehcks) or exo- (ehcks-o ̄) means
without, out of,
outside, or away from.
exocrine means to secrete externally (via
a duct).
endo- means within or inside.
endoparasite is an organism that lives
within the body of
the host.
hyper- (h ̄ı-pər) means elevated or more
than normal. hyperglycemia means
elevated amounts of blood
glucose.
inter- (ihn-tər) means between.
intercostal means between the ribs.
poly- (pohl- ̄e) means many.
polyuria means elevated amount or
frequency of
urination.
pre- (pr ̄e) means before.
preanesthetic means pertaining to
before anesthesia.
sub- (suhb) means below, under, or less.
sublingual means under the tongue.
ecto- (ehck-to ̄) means outside.
ectoparasite is an organism that lives on
the outer surface
of the host.
hypo- (h ̄ı-po ̄) means depressed or less
than normal. hypoglycemia means
depressed amounts of blood
glucose.
intra- (ihn-trah) means within.
intramuscular means within the muscle.
oligo- (ohl-ih-go ̄) means scant or little.
oliguria means depressed amount or
frequency of
urination.
post- (po ̄st) means after.
postanesthetic means pertaining to after
anesthesia.
super- (soo-pər) and supra- (soo-prah)
mean above,
beyond, or excessive.
supernumerary means more than the
regular number. suprascapular means
above the shoulder blade.
Combining Vowels : sometimes is used to make the medical term easier to
pronounce. The combining vowel is used when the suffix begins with a consonant,
as in the suffix -scope. An arthroscope is an instrument to visually examine the
joint. Because the suffix -scope begins with a consonant, the combining vowel “o” is
used. “O” is the most commonly used combining vowel; however, “i” and “e” may be
used as well.
A combining vowel is not used when the suffix begins with a vowel, as in the
suffix -itis. Gastritis is inflammation of the stomach. Because the suffix -itis begins
with a vowel, the combining vowel “o” is not used. A combining vowel is always
used when two or more root words are joined. For example, when gastr/o
(stomach) is joined with enter/o (small intestine) the combining vowel is used with
gastr/o, as in the term gastroenteritis. A combining vowel is not used be- tween a
prefix and the root word.
3.
Combining Forms: A word root plus a vowel is the combining form. Combining forms
usually describe a part of the body. New words are created when combining forms are
added to prefixes, other combining forms, and suffixes. For example, the term
panleukopenia is composed of the word parts




pan-(pahn),a prefix meaning all
leuk/o(loo-ko ̄),a combining form meaning white
-penia (p ̄e-n ̄e-ah), a suffix meaning deficiency or reduction in number
Panleukopenia is a deficiency of all types of white blood cells.
4.
Suffixes: are attached to the end of a word part to modify its meaning. For example,
the combining form gastr/o means stomach and can be modified using var- ious suffixes.
 The suffix -tomy means cutting into or incision. Gastrotomy is incision into the
stomach.
 The suffix -stomy means a surgically created opening. Gastrostomy is a surgically
created
 The suffix -ectomy means surgical removal or excision. Gastrectomy is surgical
removal of the stomach.
Many suffixes can be grouped together by meaning or by the category they modify.
Initially, when learning suffixes it is easiest if the learner groups them by meaning or
category.
“PERTAINING TO” SUFFIXES
o
o
o
o
o
o
o
o
o
o
-ac(ahck), as in cardiac(pertaining to the heart)
-al(ahl), as in renal (pertaining to the kidney)
-an(ahn),as in ovarian (pertaining to the ovary)
-ar(ahr),as in lumbar(pertaining to the loin)
-ary(ahr- ̄e),as in alimentary (pertaining to the gastrointestinal tract)
-eal ( ̄e-ahl), as in laryngeal (pertaining to the larynx)
-ic(ihck),as in enteric(pertaining to the intestines)
-ine(ihn), as in uterine(pertaining to the uterus)
-ous(uhs), as in cutaneous (pertaining to the skin)
-tic (tihck), as in nephrotic (pertaining to the kidneys)
SURGICAL SUFFIXES
o
o
o
o
o
-ectomy (ehck-to ̄ -m ̄e): surgical removal as in mastectomy, surgical removal
of the breast or mammary glands
-pexy(pehck-s e): suture to stabilize, as in gastropexy, surgically stabilizing the
stomach to the abdominal wall
-plasty (plahs-t ̄e): surgical repair, as in rhinoplasty, surgical repair of the nose
-stomy (sto ̄-m ̄e): surgically created opening, as in colostomy, a surgically
created opening between the colon and body surface
-tomy(to ̄-m ̄e): cutting into, as inl aparotomy, an incision into the abdomen
PROCEDURAL SUFFIXES
o
-centesis (sehn-t ̄e-sihs): surgical puncture to re- move fluid or gas (either for
diagnosis or to remove excess fluid or gas), as in cystocentesis, a surgical
puncture of the urinary bladder with a needle to re- move fluid (urine).
o
-gram (grahm): record of, as in electrocardiogram, the electrocardiographic
hard copy record.
o
-graph (grahf): instrument that records (or used as record), as in
electrocardiograph, the machine that records the electrical activity of the heart
o
-graphy (grahf- ̄e): procedure that records, as in electrocardiography, the
procedure used to record the electrical activity of the heart
o
-lysis (l ̄ı-sihs): separation or breakdown, as in urinalysis, separation of the
urine into its constituents.
o
-scope(sko ̄p): instrument to visually examine as in endoscope, an instrument
used to visually examine inside the body
o
-scopy(sko ̄p- ̄e)◻procedure to visually examine as in endoscopy, the
procedure of visually examining inside the body
o
-therapy (thehr-ah-p ̄e) ◻ treatment, as in chemotherapy, treatment with
chemical substances or drugs
DOUBLE “R” SUFFIXES
o
-rrhagia or -rrhage (r ̄a-j ̄e-ah or rihdj): bursting forth, as in hemorrhage,
bursting forth of blood from the vessels.
o
rrhaphy(rahf- ̄e): to suture, as in enterorrhaphy, suturing of the intestines
o
-rrhea (r ̄e-ah): flow, discharge, as in diarrhea, complete discharge of the bowels
o
-rrhexis (rehck-sihs): rupture, as in myorrhexis, rupture of the muscle
CONDITIONAL SUFFIXES
o
-algia and -dynia (ahl-j ̄e-ah or dihn- ̄e-ah): pain, as in arthralgia and
arthrodynia, or joint pain
o
-itis ( ̄ı-tihs) ◻ inflammation, as in hepatitis, inflammation of the liver
o
-malacia(mah-l ̄a-sh ̄e-ah: abnormal softening, as in osteomalacia, abnormal
softening of bone
o
-megaly (mehg-ah-l ̄e): enlargement, as in cardiomegaly, enlargement of the
heart .
o
-osis (o -̄ sihs) ◻ abnormal condition, as in cardio- sis, an abnormal condition of
the heart
o
-pathy (pahth- ̄e) ◻ disease, as in enteropathy, dis- ease of the intestines
o
sclerosis (skleh-ro ̄-sihs) ◻ abnormal hardening, as in arteriosclerosis,
abnormal hardening of the arteries
o
-um (uhm) ◻ structure, as in pericardium, structure surrounding the heart
Suffixes may change the part of speech of a word. Different suffixes may change the
word from a noun (naming people, places, or things) to an adjective (descriptor).
Examples of this include
o
cyanosis is a noun meaning condition of blue dis- coloration, whereas cyanotic
is an adjective meaning pertaining to blue discoloration
o
anemia is a noun meaning a blood condition of deficient red blood cells or
hemoglobin, whereas anemic is an adjective meaning pertaining to a blood
condition of deficient red blood cells or hemoglobin
o
mucus is a noun meaning a slime-like substance that is composed of glandular
secretion, salts, cells, and leukocytes, whereas mucous is an adjective meaning
pertaining to mucus
o
ilium is a noun meaning a part of the hip, whereas iliac is an adjective pertaining
to the hip
o
condyle is a noun meaning a rounded projection on a bone, whereas condylar
is an adjective meaning pertaining to a rounded projection on a bone
o
carpus is a noun meaning the joint between the radius and ulna and metacarpal
bones, whereas carpal is an adjective meaning pertaining to the joint between
the radius and ulna and metacarpal bones
5.
ANALYZING MEDICAL TERMS
Medical terminology can be more easily understood if the following objectives are
adhered to:
Dissect: First analyze the word structurally by di- viding it into its basic components.
Begin at the end: After dividing the word into its basic parts, define the suffix first,
the prefix second, and then the roots. If there are two roots, divide each and read
them from left to right.
Anatomical order: Where body systems are in- volved, the words usually are built in
the order in which the organs occur in the body. For example, gastroenteritis is the
proper term for inflammation of the stomach and small intestine. Because food
passes from the stomach into the small intestine, the medical term for stomach
appears before the med- ical term for small intestine. The order of word parts in a
medical term may also represent the order of blood flow through organs. The
exception to this in- volves some diagnostic procedures in which tools or substances
are passed retrograde or in the opposite direction of anatomic order. In these cases
the words are built in the order in which the equipment passes the body part.
Using these guidelines, analyze the term ovariohysterec- tomy. First divide the
term into its basic components: ovari/o/hyster/ectomy. Defining from back to front,
the suffix -ectomy is surgical removal, one combining form ovari/o means ovary,
and the other combining form hys- teri/o means uterus. Together the term
ovariohysterec- tomy means surgical removal of the ovaries and uterus. This term
is based on the order in which the ovaries and uterus are found in the body.
B. Abbreviations
Abbreviations are used widely in the health care field. In most cases, a particular
abbreviation has only one widely used meaning within the medical field. For
instance, MD, HIV, and Rx have unambiguous meanings in virtually any medical
context (meaning “doctor of medicine,” “human immunodeficiency virus,” and
“prescription,” respectively).
A few abbreviations are more context specific. For instance, AE may mean
“above the elbow” to a phlebotomist reading a chart about a burn victim’s scars, but it
may mean “adverse effects” to a pharmacist comparing side effects of two drugs.
Because of the potential for confusion, The Joint Commission has recommended
avoiding certain abbreviations.
LESSON IX
Basics Concepts on Laboratory Biosafety and Biosecurity
I.
Introduction:
Concepts of biosafety and biosecurity deal with related but distinctly different issues.
Biosafety describes the containment principles, technologies and practices that are
implemented to prevent the unintentional exposure to pathogens and toxins, or their
accidental release while Biosecurity describes the protection, control and accountability for
valuable biological materials within laboratories, in order to prevent their unauthorized
access, loss, theft, misuse, diversion or intentional release.
II.
Objectives
At the end of the learning session, the student must be able to:
III.
o
Outline the history and the related policies and guidelines governing laboratory
biosafety and biosecurity;
o
Compare the fundamental concepts between laboratory biosafety and biosecurity;
o
Recognize the different local and international organizations of biosafety;
o
Classify microorganisms according to risk group
o
Categorize laboratories according to biosafety level
Lesson Outline
A. Laboratory Biosafety
1. History and Guidelines on Laboratory Biosafety and Biosecurity
2. Local and international organization on biosafety
3. Fundamental concepts of Laboratory biosafety and biosecurity
B. Classification of Microorganisms according to Risk group
C. Classification of Laboratory according to biosafety levels.
IV.
Lesson
Brief History of Laboratory Biosafety
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, but was eventually terminated by US President Richard Nixon in
1969.
After the Second World War, Camp Detrick was designated a permanent
installation for biological research and development, and biosafety has become an
inherent component of biological weapons development. Later, Newell A. Johnson
designed modifications for biosafety at Camp Detrick. 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.
In 1944, Arnold Wedum, director of Industrial Health and Safety at the US Army
Biological Research Laboratories, was recognized as one of the pioneers of biosafety
that provided the foundation for evaluating the risk of handling infectious
microorganisms and for recognizing biological hazards and developing practices,
equipment, and facility safeguards for their control.
In 1966, Wedum and a colleague, microbiologist Morton Reitman, analyzed multiple
epidemiological studies of laboratory-based outbreaks.
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).
Prior to this developments, there were inventions to address prevention of
laboratory acquired infections that includes:
o
Arnold Wedum described the use of mechanical pipettors to prevent
laboratory-acquired infections in 1907 and 1908 (Kruse (1991), cited by
Salerno, 2015).
o
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.
o
In 1909, a pharmaceutical company in Pennsylvania developed a ventilated
cabinet to prevent infection from Mycobacterium tuberculosis.
o
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). World Health Assembly consolidated the
remaining virus stocks into two locations:
o
o
Center for Disease Control and Prevention (CDC) in USA
State Research Center of Virology and Biotechnology VECTOR
(SRCVB VECTOR) in Russia.
The concept of establishing ascending levels of containment associated with risks in
handling groups of microorganisms that present similar characteristics was introduced
by the CDC through the publication of Classification of Etiological Agents on the Basis of
Hazard.
o
o
o
Technical means of mitigating the risk of accidental infection from or
release. of agents in the laboratory setting as well as the community and
environment it is situated in.
Concentrate a combination of engineered controls, administrative
controls, and practices.
Emphasize the equipment and facility controls with little attention given to
risk assessment
The 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.
The National Institutes of Health (NIH) of the US published the NIH Guidelines for
Research Involving Recombinant DNA molecules in 1976 which explained in detail the
microbiological practices, equipment, and facility necessarily corresponding to four
ascending levels of physical containment.
The development of the practice of laboratory safety was marked by the introduction
of a code of biosafety practice together with WHO’s first edition of Laboratory Biosafety
Manual (1983) and the CDC and NIH’s jointly published first edition of the Biosafety in
Microbiological and Biomedical Laboratories (1984).
Biosafety officers 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.
Brief History of Biosecurity
In 1996, the Select Agent Regulations was enacted by the US government to monitor
the transfer of a select list of biological agents from one facility to another.
Terrorist attacks and anthrax attacks, known as Amerithrax, escalated in the US in 2001
which made the US government change the perspective of the Select Agent Regulations.
The revised Select Agents regulations required specific security measures for any facility
in the US that use 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:
o
o
Tier 1 agents – materials that pose the great risk of deliberate misuse
And the remaining select agents
Other countries relatively implemented and prescribed biosecurity regulations for
bioscience facilities:
o
Singapore’s Biological Agents and Toxins Act is similar to the US regulations but
with more severe penalties for noncompliance.
o
South Korea’s amended Act on Prevention of Infectious Diseases in 2005
required institutions that work with the listed “highly dangerous pathogens” to
implement laboratory biosafety and biosecurity requirements.
o
Japan’s Infectious Disease Control Law was recently amended under Japan’s
Ministry of Health, Labor and Welfare which established four schedules of select
agents that are subject to different reporting and handling requirements for
possession, transport and other activities.
o
Canadian containment level (CL) 3 and CL 4 facilities that work with risk group 3
and 4 are required to undergo certification.
o
The Danish Parliament passed a law in 2008 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.
o
Around the world, biosecurity implementation has become a purely administrative
activity based on a government checklist
Local and International Guidelines on Laboratory Biosafety and Biosecurity
On February 2008, Comité Européen de Normalisation (CEN), European Committee
for Standardization published the CEN Workshop Agreement 15793 (CWA 15793) that
focuses on laboratory biorisk management . It offers a mechanism where stakeholders can
develop consensus standards and requirements in an open process. This can be applied
to international stakeholders, however, they do not have the force of regulation while
conformity is voluntary.
The CEN Workshop Agreement 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.
The WHO in 1983 published its 3rd edition of the Laboratory Biosafety Manual. This
is to address concerns on biosafety guidance for research and health laboratories, issues
On risk assessment and guidance to commission and certify laboratories. 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 equipments.
It also covers the packaging required by international transport regulations other types
of safety procedures for chemical, electrical, ionizing radiation, and fire hazards. The
emphasis of the manual is the continuous monitoring and improvement directed by a
biosafety officer and the biosafety committee.
Unfortunately, there is no mechanism to insure that the WHO biosafety guidance
is being adhered to, or that people working in laboratories are sufficiently
trained.
In 2003,The Cartagena Protocol on Biosafety (CPB) was established, It applies to the
168 member-countries which 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 purpose. It also provides a framework for assessing the risk of LMOs
and is focused on ensuring that LMOs do not negatively affect biodiversity.
In the Philippines under E.O. 430 series of 1990The new National Committee on
Biosafety of the Philippines (NCBP) was established. It is focused on the organizational
structure for biosafety which includes
o
o
o
procedures for evaluation of proposals with biosafety concerns;
procedures and guidelines on the introduction, movement, and field release of
regulated materials;
procedures on physico-chemical and biological containment
On March 17, 2006, the Office of the President promulgated EO 514 establishing the
National Biosafety Framework (NBF). This pertains to the guidelines for its
implementation, strengthening the National Committee on Biosafety of the Philippines. It is
a combination of policy, legal, administrative, and technical instruments developed to attain
the objective of the Cartagena Protocol on Biosafety which the Philippines signed on May
24, 2000 and considered as an expansion of the NCBP, which since 1987 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 also issued Administrative Order No. 8 to 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
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
American Biological Safety Association (ABSA), a regional professional
society for biosafety and biosecurity founded in 1984. It promotes biosafety as a scientific
discipline and provides guidance to its members on the regulatory regime present in North
America
Asia-Pacific Biosafety Association (A-PBA). Founded in 2005; acts as a
professional society for biosafety professionals in the Asia-Pacific region. The active
members of the International Biosafety Working Group are required to directly contribute to
the development of the best biosafety practices
European Biological Safety Association (EBSA). A non-profit organization founded
in June 1996. It aims to provide a forum for discussions and debates on issue of concern
and to present those working on the field of biosafety
Philippine Biosafety and Biosecurity Association (PhBBA). Created by a multidisciplinary team with members coming from the health an education sectors as well as
individuals from the executive, legislative and judicial branches of the government. It also
include are members of the steering committee and technical working groups of the
National Laboratory Biosafety and Biosecurity Action Plan Task Force established as per
DPO No. 2006-2500 dated September 15, 2006. Its long-term goal is to assist the DA and
DOH in their efforts to create a national policy and implement plan for laboratory biosafety
and biosecurity
Biological Risk Association Philippines (BRAP). A non-government and non-profit
association that works to serve the emergent concerns of biological risk management in
various professional fields such as in the health, agriculture, and technology sectors
throughout the country. It has launched multiple activities in cooperation and collaboration
with other associations, on the national and international sale in the promotion of biosafety,
biosecurity, and biorisk management as scientific discipline. It goes by the tagline, “assess,
mitigate, monitor”
Fundamental Concepts of Laboratory Biosafety and Biosecurity
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 2006, the WHO referred to biosecurity as “the protection, control and accountability
for valuable biological materials within laboratories, in order to prevent their unauthorized
access, loss, theft, misuse, diversion, or intentional release.”
By simple definition, “biosafety protects people from germs” while “biosecurity protects
germs from people.”
Charles Baldwin, an environmental health engineer working for the Dow Chemical
Company containment systems products, created the biohazard symbol used in labeling
biological materials carrying significant health risks in 1966.
Biosafety focuses on laboratory procedures and practices necessary to prevent
exposure to and acquisition of infections. Biosecurity focuses on the maintenance of secure
procedures and practices in handling biological materials and sensitive information.
Classifications of Microorganisms According to Risk Group
Risk Groups are classifications that describe the relative hazard posed by infectious
agents or toxins in the laboratory. The risk group to which an infectious agent or toxin is
assigned is the primary, but not only, consideration used in a biological risk assessment to
determine the appropriate biosafety level in which a worker can handle the infectious agent or
toxin. Other considerations used in a biological risk assessment include the ability of an
infectious agent or toxin to cause disease, the way in which the infectious agent or toxin causes
disease, the activities performed in the laboratory, the safety equipment and design elements
present in the laboratory, and the health and training of the laboratory worker
Risk Group 1
Risk Group 2
Risk Group 3
Risk Group 4
Safety Level 1
Safety Level 2
Safety Level 3
Safety Level 4
Description
Risk Group 1
organisms do
not cause
disease in
healthy adult
humans.
Risk Group 2
organisms can
cause disease in
humans, but the
disease is treatable
or preventable.
Risk Group 3
organisms cause
serious disease
in humans.
Treatments and
vaccines for
these diseases
may exist.
Risk Group 4 organisms
cause deadly disease in
humans, and they can
easily travel from one
person to another. No
treatments or vaccines
exist for these diseases.
Typical
Work Area
Open bench
Biosafety cabinet
Class 3 biosafety
cabinet
Full isolation suits
Examples
E. coli K12, S. cerevisia
e (yeast), Lacto
bacillus, B. subt
ilis
Streptococcus,
Herpes virus, most
mammalian cell
lines
Yersinia pestis (
black plague),
HIV, SARS virus
Ebola virus, Marburg
virus, Lassa virus
Lab Safety
Level
Typical Lab
Photo
Categories of Laboratory Biosafety According to Levels
Biosafety levels (BSL) are used to identify the protective measures needed in a
laboratory setting to protect workers, the environment, and the public. The levels are defined in
Biosafety in Biomedical Laboratories. Biosafety level designations in the BMBL outline specific
practices and safety and facility requirements. There are many ways to combine equipment,
practices, and laboratory design features to achieve appropriate biosafety and biocontainment.
These are determined through biological risk assessments specifically conducted for each
experimental protocol.
Biosafety Level 1 (BSL-1)
BSL-1 labs are used to study infectious agents or toxins not known to consistently
cause disease in healthy adults. They follow basic safety procedures, called Standard
Microbiological Practice and require no special equipment or design features. Standard
engineering controls in BSL-1 laboratories include easily cleaned surfaces that are able to
withstand the basic chemicals used in the laboratory.
Biosafety Level 2 (BSL-2)
BSL-2 laboratories are used to study moderate-risk infectious agents or toxins that
pose a risk if accidentally inhaled, swallowed, or exposed to the skin. Design requirements for
BSL-2 laboratories include hand washing sinks, eye washing stations in case of accidents, and
doors that close automatically and lock. BSL-2 labs must also have access to equipment that
can decontaminate laboratory waste, including an incinerator, an autoclave, and/or another
method, depending on the biological risk assessment.
Biosafety Level 3 (BSL-3)
BSL-3 laboratories are used to study infectious agents or toxins that may be
transmitted through the air and cause potentially lethal infection through inhalation exposure.
Researchers perform all experiments in biosafety cabinets that use carefully controlled air flow
or sealed enclosures to prevent infection. BSL-3 laboratories are designed to be easily
decontaminated. These laboratories must use controlled, or “directional,” air flow to ensure
that air flows from non-laboratory areas (such as the hallway) into laboratory areas as an
additional safety measure.
Other engineered safety features include the use of two self-closing, or interlocked,
doors, sealed windows and wall surfaces, and filtered ventilation systems. BSL-3 labs must
also have access to equipment that can decontaminate laboratory waste, including an
incinerator, an autoclave, and/or another method, depending on the biological risk
assessment.
Biosafety Level 4 (BSL-4)
BSL-4 laboratories are used to study infectious agents or toxins that pose a high risk of
aerosol-transmitted laboratory infections and life-threatening disease for which no vaccine or
therapy is available. The laboratories incorporate all BSL 3 features and occupy safe, isolated
zones within a larger building or may be housed in a separate, dedicated building. Access to
BSL-4 laboratories is carefully controlled and requires significant training.
There are two types of BSL-4 laboratories:


Cabinet laboratory – all work with infectious agents or toxins is done in a Class
III Biosafety Cabinet with very carefully designed procedures to contain any potential
contamination. In addition, the laboratory space is designed to also prevent
contamination of other spaces.
Suit laboratory – Laboratory personnel are required to wear full-body, air-supplied suits,
which are the most sophisticated type of PPE. All personnel shower before exiting the
laboratory and go through a series of procedures designed to fully decontaminate them
before leaving.
The engineering controls required are different for BSL-4 cabinet and suit laboratories. For
either type, they are extensive and supplemented by carefully designed procedures and
practices.