MODULE 1: NATURE OF THE CLINICAL Classifications Of a
LABORATORY According to Function
Intended Learning Outcomes
At the end of the lesson, the students should be able
to:
1. Discuss the different sections of the clinical
laboratory and the tests done in each.
2. Compare and contrast the different types of
clinical laboratory.
Clinical Laboratory
➢ is a place where specimens collected from
individuals are processed analyzed
preserved and properly disposed
➢ A clinical laboratory refers to a facility
subdivided into different sections where
common diagnostic procedures are done by
specialized health professionals.
➢ Diagnostic tests and procedures are
conducted to produce laboratory findings
that can be used to evaluate the clinical
course of infections.
➢ Computerization and automation
➢ Establish a quality control and assurance
program
The regulation of clinical laboratories in the
`Philippines is governed by R. A. 4688, also known
as the Clinical Laboratory Law of 1966 which was
approved on June 18, 1966
It aims to ensure the health of the general public by
preventing the operation of substandard
laboratories.
The agency assigned to this task was the DOH
through the Bureau of Research and Laboratories
(BRL) which is now under Bureau of Health Facilities
and Services (BHFS).
In recent revision, AO 59 s. 2001 instituted the
following types of Laboratories.
Clinical Laboratory:
1. Clinical Pathology
➢ Is a clinical laboratory that focuses on the
areas of clinical chemistry,
immunohematology and blood banking,
medical microbiology, immunology and
serology, hematology, parasitology, clinical
microscopy, toxicology, therapeutic drug
monitoring, and endocrinology, among
others. It is concerned with the diagnosis and
treatment of diseases performed through
laboratory testing of blood and other body
fluids.
2. Anatomic Pathology
➢ Is a clinical laboratory that focuses on the
areas of histopathology,
immunohistopathology, cytology, autopsy,
and forensic pathology among others. It is
concerned with the diagnosis of disease
through microscopic examination of tissues
and organs.
Classifications Of a Clinical Laboratory:
According to Institutional Characteristics
1. Institution-Based
➢ Is a clinical laboratory that operates within
the premises or part of an institution such as
a hospital, school, medical clinic, medical
facility for overseas workers and seafarers,
birthing home, psychiatric facility, drug
rehabilitation center, and others. Hospital-
based clinical laboratories are the most
common example of institution-based
laboratories.
2. Free-Standing Clinical Laboratory
➢ Clinical laboratory is not a part of an
established institution. The most common
example is a free-standing out-patient clinical
laboratory.
Classifications Of a Clinical Laboratory:
According to Ownership
1. Government-Owned
➢ Clinical laboratories are owned, wholly or
partially, by national or local government
units.
2. Privately-Owned
➢ Clinical laboratories are owned, established,
and operated by an individual, corporation,
institution, association, or organization.
Classifications Of a Clinical Laboratory:
According to Service Capability
1. Primary Category
➢ Are licensed to perform basic, routine
laboratory testing, namely, routine analysis,
routine stool examination, routine
hematology or complete blood count that
includes hemoglobin, hematocrit, WBC and
RBC count, WBC differential count and
qualitative platelet count, blood typing, and
Gram staining (if hospital-based). Space
requirement is at least 10 square meters.
➢ No clinical chemistry examination.
2. Secondary Category (Hospital and Non-Hospital
Based)
➢ Are licensed to perform laboratory tests
being done by the primary category clinical
laboratories along with routine clinical
chemistry tests like blood glucose
concentration, blood urea nitrogen, blood
uric acid, blood creatinine, cholesterol
determination, qualitative platelet count, and
if hospital based, Gram stain, KOH mount,
and crossmatching. A minimum requirement
of 20 square meters is needed for the floor
are of this type of laboratory.
3. Tertiary Category (Hospital and Non-Hospital
Based)
➢ Are licensed to perform all the laboratory
tests performed in the secondary category
laboratory plus (1) immunology and serology
(hepatitis profile); (2) microbiology,
bacteriology, and mycology (differential
staining techniques, culture and identification
of bacteria and fungi from specimens,
antimicrobial susceptibility testing); (3)
special clinical chemistry (clinical
enzymology, therapeutic drug monitoring,
markers for certain diseases); (4) special
hematology (bone marrow studies, special
staining for abnormal blood cells, red cell
orphology); and (5) immunohematology and
blood banking (blood donation program,
antibody screening and identification,
preparation of blood components).
➢ Tertiary laboratories have a minimum floor
area of at least 60 square meters. Equipment
requirements include those seen in
secondary category laboratories along with
automated chemistry analyzer, biosafety
cabinet class II, serofuge, among others.
4. NRL (National Reference Laboratory)
➢ Is a laboratory in a government hospital
designated by the DOH to provide special
diagnostic functions and services for certain
diseases. These functions include referral
services, provision of confirmatory testing,
assistance for research activities,
implementation of External Quality
Assurance Programs (EQAP) of the
government, resolution of conflicts regarding
test results of different laboratories, and
training of medical technologists on certain
specialized procedures that require
standardization.
Sections of the Clinical Laboratory
1. Clinical Chemistry
➢ This section is intended for testing blood and
other body fluids to quantify essential soluble
chemicals including waste products useful
for the diagnosis of certain diseases.
➢ Blood and urine are the two most common
➢ One of the busiest, state of the art full
automated facility
➢ Endocrinology: testing of hormones
➢ Toxicology and drug testing
➢ Internal Quality Assurance (IQA),
Continuous Quality Improvement (CQA), and
participation in National External Quality
 Assurance Program (NEQAP) are important Cellular Components of Blood
activities that medical technologists perform
and are responsible for.
➢ CQI

2. Microbiology
➢ This section is subdivided into four
sections:
o Bacteriology – examination of
bacterium
o Mycobacteriology – focus on
mycobacterium
o Mycology – study of fungi 4. Clinical Microscopy
o Virology – study of viruses
➢ the most common specimens are blood and a. Macroscopic Examinations
other body fluids, stool swabs from different ➢ color
sites of the body ➢ transparency
➢ specific gravity
➢ pH level
Activities in Microbiology Section ➢ chemical properties of urine (glucose,
a. Microscopic visualization of microorganisms after protein, specific gravity, ketones, nitrite,
staining, isolation, and identification of bacteria and leukocytes)
fungi.
b. Antibacterial. Antimicrobial susceptibility testing. b. Microscopic Examinations
c. Preparation of culture media and stains ➢ To detect presence of abnormal cells and
d. Quality control and quality assurance parasites
➢ To quantify red cells and WBC
e. Infection control and biosafety ➢ To check on the presence of other chemicals
found in urine
f. Proper waste disposal
g. Mycobacteriology for identification of
mycobacterium

3. Hematology and Coagulation Studies

➢ Enumeration of cells in the blood and other
body fluids
➢ Examinations done include: CBC, blood
smear preparation and staining of body fluids
➢ Coagulation studies 5. Blood Bank/Immunohematology
➢ Automated machines: Automated
hematology analyzers ➢ blood typing
➢ Bone marrow examination ➢ compatibility testing
➢ peripheral blood smear examination ➢ screening for all antibodies
➢ identification of antibodies
➢ screening of blood components used for
blood transfusion
 ➢ Hospital-based laboratories (HBL) – blood
donation activities such as donor recruitment
and screening, bleeding donor and post-
donation care
6. Immunology and Serology
➢ Analysis of serum antibodies in certain
infectious agents (primarily of viral origin)
➢ Immunology is the study of the body's
immune system and its functions and
disorders. Serology is the study of blood
serum (the clear fluid that separates when
blood clots).
Immunology and serology laboratories focuses on
the following:
➢ Identifying antibodies. These are proteins
made by a type of white blood cell in
response to a foreign substance (antigen) in
the body.
➢ Investigating problems with the immune
system. These include when the body's
immune system attacks its own tissues
(autoimmune diseases) and when a body's
immune system is underactive
(immunodeficiency disorders - HIV).
➢ Determining organ, tissue, and
fluid compatibility for transplantation.
ANATOMIC PATHOLOGY
➢ Section of Histopathology/Cytology
➢ Histopathology
o Examination of tissues
o Microscopic examination of tissues
o Gross examination of tissues
➢ Cytology
o Microscopic examination of abnormal
cells that may contribute to the
diagnosis of a certain disease like
cancer
SPECIALIZED SECTIONS OF THE
LABORATORY
➢ Immunohistochemistry
o It is a specialized section of the
laboratory that combines anatomical,
clinical, and biochemical techniques
where antibodies (monoclonal and
polyclonal) bounded to enzymes are
fluorescent dyes are used to detect
presence of antigens in tissue. This is
useful in the diagnosis of some types
of cancers by detecting the presence
of tumor-specific antigens,
oncogenes, and tumor suppressor
genes. It can also be used to assess
the responses of patients to cancer
therapy as well as diagnosis of
certain neurodegenerative disorders.
➢ Molecular biology and biotechnology
o The different enzymes and other
reagents
o DNA and RNA (for the detection of
SARS-COV 2 Virus) are being
identified and sequenced to detect
any pathologic conditions/disease
process.
o Vital section during pandemic
IN ADDITION TO THE DIFFERENT TYPES OF
CLINICAL LAB
1. LIMITED SERVICE CAPABILITY:
A. Dialysis center
B. Social hygiene clinics
2. SPECIAL CLINICAL LABORATORIES:
A. Assisted reproduction technology lab
B. Molecular and cellular technology
C. Molecular biology
D. Molecular pathology, forensic and anatomic
pathology
3. NRL
➢ a lab in a government hospital which has
been designated by the DOH to provide
special functions and services such as the
following:
o a. confirmatory testing
o b. surveillance
o c. resolution of conflicts
o d. training and research
o e. evaluation of kits and reagents
o f. external quality assessment
program

Satellite Testing Sites

➢ any testing site that performs lab
examinations under the administrative
control of a licensed lab but outside the
physical confines of the lab
➢ Ex. Ambulatory Care Services of LUDH,
MMG Plus

Mobile Clinical Lab

➢ a lab testing unit that moves from one testing
site to another site or has a temporary testing
location and a base laboratory
➢ shall be licensed as part of the main clinical
lab and is permitted to collect specimens only
➢ shall be allowed to operate only within a 100-
km radius from its laboratory