NATURE

OF
CLINICAL
LABORATORY

Jonna E. Agabe – Tacsay,RMT,MSMT

Rochelle D. Darlucio, RMT
College of Medical Laboratory Science
Our Lady of Fatima University - Valenzuela
Lesson Intended Learning Outcomes (LILO)
At the end of the lesson, the student shall be able to:
• Discuss the different sections of the laboratory and tests done in each
• Compare and contrast the different types of clinical laboratory and give
examples of each.
• Explain the salient points of the laws governing the establishment ,
operation, and maintenance of Clinical Laboratory in the Philippines.
• Discuss the importance of Quality Assurance in the Clinical Laboratory
• Explain the difference between internal and external quality assurance/
control
• Enumerate the different national reference laboratory considered as leads
in the External Quality Assurance Program of the country.
• Discuss the laboratory cycle testing and the role of medical technologist
on each cycle.
CLINICAL LABORATORY
 Refers to a facility subdivided into different sections where common
diagnostic procedures are done by specialized health professionals.

 The regulation of Clinical Laboratories in the Philippines is governed

by Republic Act 4688.

Republic Act 4688

 Aims to ensure the health of the general public by preventing the
operation of substandard laboratories
 Department of Health through the Bureau of Research and
Laboratories (BRL)
 Bureau of Health Facilities and Services (BHFS) – Administrative
order 59 s. 2001
CLASSIFICATION OF
CLINICAL LABORATORIES
(Based on AO 59 s. 2001)

ACCORDING TO FUNCTION:
Clinical Pathology Anatomic Pathology
Hematology Surgical Pathology
Clinical Chemistry Immunohistopathology
Microbiology Cytology
Parasitology Autopsy
Mycology Forensic Pathology
Clinical Microscopy
Immunohematology
Blood Banking
Laboratory Endocrinology
Toxicology and Therapeutic Drugs
Monitoring
CLASSIFICATION OF
CLINICAL LABORATORIES
(Based on AO 59 s. 2001)

ACCORDING TO INSTITUTIONAL CHARACTER:

Hospital-Based (HB) Non-hospital-based (NHB)
CLASSIFICATION OF
CLINICAL LABORATORIES
(Based on AO 59 s. 2001)

ACCORDING TO SERVICE CAPABILITY (Examination Performed)

Primary Secondary Tertiary

1. Routine 1. Primary laboratory 1. Secondary
Hematology examination laboratory
2. Routine urinalysis 2. Routine chemistry examination
3. Routine fecalysis 3. Blood typing and 2. Special chemistry
4. Blood typing- HB crossmatching - 3. Special
5. Quantitative HB hematology
platelet 4. Immunology/
determination - HB Serology
5. Microbiology
CLASSIFICATION OF
CLINICAL LABORATORIES
(Based on AO 59 s. 2001)

ACCORDING TO SERVICE CAPABILITY (Minimum Facilities Required)

Primary Secondary Tertiary

1. Clinical Centrifuge 1. Primary laboratory 1. Secondary laboratory
2. Hemacytometer equipment/ equipment/
3. Microhematocrit instruments instruments
centrifuge 2. Refrigerator 2. Incubator
4. Microscope with 3. Photometer or its 3. Trip/ analytical
OIO equivalent balance
5. Hemoglobinometer 4. Water bath or its 4. Rotator
or its equivalent equivalent 5. Serofuge or its
6. Differential blood 5. Timer or its equivalent
cell counter or its equivalent 6. Autoclave
equivalent 7. Drying over
8. Biosafety cabinet or
its equivalent
CLASSIFICATION OF
CLINICAL LABORATORIES
(Based on AO 27 s. 2007)

According to According to According to

Ownership Function Institutional Character
1. Government 1. Clinical Pathology 1. Institution-based

2. Private 2. Anatomic Pathology 2. Freestanding

CLASSIFICATION OF
CLINICAL LABORATORIES
(Based on AO 59 s. 2001)

ACCORDING TO SERVICE CAPABILITY (Examination Performed)

Primary Secondary Tertiary

1. Routine 1. Primary laboratory 1. Secondary
Hematology examination laboratory
2. Routine urinalysis 2. Routine chemistry examination
3. Routine fecalysis 3. Quantitative 2. Special chemistry
4. Blood typing- HB platelet 3. Special
5. Qualitative determination hematology
platelet 4. Crossmatching- HB 4. Immunology/
determination 5. Gram staining / Serology
KOH - HB 5. Microbiology
Additional Notes:

1. National Reference Laboratory (NRL)

• Laboratory in a government hospital which has been
designated by the DOH to provide special functions
and services such as the following:

a. Confirmatory testing
b. Surveillance
c. Resolution of conflicts
d. Training and research
e. Evaluation of kits and reagents
f. External quality assessment program
2. Satellite Testing Sites
• Any testing sites that performs laboratory
examinations under the administrative control
of a licensed laboratory but outside the
physical confines of the laboratory

3. Mobile clinical laboratories

• A laboratory testing unit that moves from one
testing site to another testing site or has a
temporary testing location and a “base
laboratory”
Common Laboratory Tools
and Equipment
 Centrifuge  Oven
 A motor – driven  A thermostatically
machine that spins an controlled chamber
object around a fixed axis which is used for dry
 It operates using the heating
dimentation principle
Common Laboratory Tools
and Equipment
 Autoclave  Microtome
 A device used to sterilize  A machine used to cut uniformly
thin slices of tissue blocks
equipment and culture media by
subjecting them to a pressure sat known as sections
urated steam at 121oC for 15 – 20
minutes
Common Laboratory Tools
and Equipment
 Sphygmomanometer
 A device used to measure
blood pressure.
 Water bath
 A water – filled vessel in
laboratories to incubate
samples maintained at a
constant temperature
Common Laboratory Tools
and Equipment
 Spectrophotometer  Counting chamber
 A thick specimen slide engraved
 Also called a photometer
with fine – quality, laser – etched grids
 Quantitatively measures the
 Used in counting the cellular
amount of light that a sample absorbs
elements of the blood such as red blood
cells, white blood cells, and platelets
Common Laboratory Tools
and Equipment
 WBC Differential Counter
 A handy device used in hematology to
manually count and classify white
blood cells
 Pipettes
 Also called pipets, pipettors,
or chemical droppers
 Tools used to measure and
transfer small volume of liquids
Common Laboratory Tools
and Equipment
 Incubator
 An apparatus used to grow and maintain microbiological and cell cultures.
Products commonly used by
Medical Technologists
 Evacuated blood collection  Culture medium
tubes  A liquid or gel component that
 Vaccum – filled tubes used to contain supports the growth of
pre – determined volumes of blood microorganisms such as
samples bacteria, yeast or cells
 The tube – top is color – coded
according to the type of anticoagulant an
d additives loaded in the tubes
Products commonly used by
Medical Technologists
Staining dyes
 Can be from natural or synthetic
preparations that imparts variety of
colors to tissues or microorganisms.
 Syringe
 A simple pump consisting of a
plunger fitted tightly in a
cylindrical tube called a barrel
Products commonly used by
Medical Technologists
Blood bag
 A sterile medical bag used in the
collection, processing and storage of
whole blood and blood components in
transfusion
 Typing sera
 Reagents commonly used in
blood typing
 Prepared from human or animal
serum and contain antibodies
that can specifically react to
one or more antigens
Products commonly used by
Medical Technologists
Capillary tube  Urine dipstick
 A very thin, disposable tube used to  Also called a urine test strip
collect small amounts of liquid samples  Used to determine the
by means of capillary action pathological changes in a patient’s
urine in routine urinalysis
Products commonly used by
Medical Technologists
Rapid diagnostic kits
 Commercially available test kits
which are simple and easy to use
 Tourniquet
 An elastic bandage applied to a
patient’s extremities to constrict
blood vessels and make the
venipuncture site more
prominent during phlebotomy
Sections of the
Clinical Laboratory
• Clinical Chemistry
• Hematology
• Immunohematology/Blood Bank
• Immunology/Serology
• Medical Microbiology
• Analysis of Urine and Blood Fluids (Clinical
Microscopy)
• Histopathology
Clinical Chemistry

• Involved in the analysis of biological materials, usually bodily fluids,

to provide diagnostic results on the state of the human body.

• Test procedures are usually performed on serum

ROUTINELY REQUESTED CLINICAL CHEMISTRY ASSAYS
A. Blood Glucose
B. Blood Lipid Profile
C. Kidney (Renal) Function tests
D. Liver Function Tests
E. Cardiac Function Tests
F. Special Chemistry Tests: Tumor Markers
Clinical Chemistry Services Clinical Significance
Electrolytes Na+, K+, Cl-, HCO3, PO4-3, Ca+2, Mg+2, etc.

Enzymes Alkaline phosphatase, acid phosphatase,

Creatine phosphokinase, Lactic acid
dehydrogenase, Glutamic-Oxalacetic
Transaminase, Amylase, etc.

Proteins Total protein, Albumin, Globulin, Pre-albumin,

Alpha globulins, Beta-globulins,
Immunoglobulins, etc.

Organics Glucose, Urea, Uric acid, Creatinine,

Cholesterol, etc.
 Profile Type Composition of example profiles

Renal (Kidney) Na+, K+, Cl-, HCO3-, PO4-3, Urea

Nitrogen, Creatinine, Uric acid,
albumin

Hepatic (liver) Total bilirubin, Direct bilirubin, AST,

ALT, ALP, Cholesterol, Total protein,
albumin, globulin

Cardiac (Heart) CPK, LDH, Troponin I, Myoglobin

Hypertensive Cholesterol, HDL, LDL, VLDL,

Triglycerides

Thyroid Thyroxin, Free thyroxin, TSH

Hematology

• Scientific study of blood, its components, and blood diseases.

• Includes the study of etiology, diagnosis, treatment, prognosis and p

revention of blood diseases.

• Whole blood is used for the majority of test procedures.

Blood Bank
• Deals with the uses of immunologic principles to study and identify t
he different blood groups

• Separate area in a clinical laboratory where blood is collected from d

onors.

• Prepares blood and blood components for transfusion

Microbiology
• Study of microorganisms too small to be seen by unaided eye.

• A broad term which includes virology, mycology, parasitology,

bacteriology.

• Responsible for growing and identifying the organisms obtained

from patient’s blood, urine, or other body fluids, sputum, or wound.

• After the organism is grown out (culture), susceptibility testing can

be performed.
Immunology/ Serology
• Immunology is defined as the study of all the aspects of the immune system,
including its structure and function.
• Deals with the response of an organism to antigenic challenge and its
recognition of what is self and non self.

• Serology is a division of immunology that deals with the specializes in the

laboratory detection and measurement of antigens and antibodies.
• Serological tests may be performed for diagnostic purposes when an
infection is suspected and helps to diagnose patients with
immunodeficiencies associated with the lack of antibodies.
Clinical Microscopy

• Performs scientific analysis of non-blood body fluids such as urine,

semen, and stool.
ROUTINE URINALYSIS
• The macroscopic, chemical, and microscopic examinations of urine provide initial valuable diagnostic
information concerning metabolic dysfunctions of both renal and non renal origin.

1. Chemical Tests for abnormal chemical constituents

• The common chemical testing of urine utilizes commercial disposable test strips
• The result of testing is regarded as semi-quantitative
• A fresh urine specimen is collected in a clean, dry container. A multistix strip is briefly immersed in the
urine specimen, covering all reagent areas.
ROUTINE URINALYSIS

2. Microscopic exam for abnormal insoluble constituents

• Looks for formed cellular elements, casts, bacteria, yeasts, parasites and crystals
in centrifuged urine sediment
SEMEN ANALYSIS
• Important in evaluating fertility cases and status of post vasectomy cases.
STOOL EXAMINATION

• Fecalysis, stool concentration technique, occult blood determination

and stool examination for fats help clinician in early detection of
gasto-intestinal bleeding, liver and biliary duct disorders and
malabsorption syndrome.
Histopathology
• Refers to the microscopic examination of tissue in order to study the
manifestations of disease.
• Examination of a biopsy or surgical specimen by a pathologist, after
the specimen has been processed and histological sections have be
en placed onto glass slides.

Two sources of specimens:

• 1. Autopsy specimen
• 2. Biopsy specimen
ROUTINE HISTOPATHOLOGIC EXAMINATION
A. Numbering
• Process of recording the tissue specimen in a log book and assigning identi
fication numbers to the specimen received in the laboratory
B. Fixation
• Preserving the tissue specimen in a like-like manner as possible.
ROUTINE HISTOPATHOLOGIC EXAMINATION

C. Dehydration
• Process of removing water from the specimen by using increasing grades of ethyl
alcohol
D. Clearing
• Also known as de-alcoholization
• Process of removing excess alcohol in the tissues and making the tissues transparent.
ROUTINE HISTOPATHOLOGIC EXAMINATION

E. Infiltration
• the process of filling up the tissue spaces or cavities using a paraffin wax
F. Embedding/Molding
• The process of placing the infiltrated tissue inside a mold.
ROUTINE HISTOPATHOLOGIC EXAMINATION

G. Trimming
• The process of removing the excess paraffin wax from the block until it assumes th
e shape of a truncated pyramid.
H. Sectioning
• Also known as microtomy
• A tissue block is cut into thin slices called ribbons/section using microtome.
ROUTINE HISTOPATHOLOGIC EXAMINATION

I. Staining
• The process that employs the use of hematoxylin and eosin dyes to differentiate
the cells and the cellular constituents.
J. Mounting
• The process of putting the coverslip on the stained tissue using a mounting medium
K. Labeling
• Means of identifying the specimen. The specimen number is indicated on the glass
slide.
Cycle of Clinical Laboratory
Testing
Cycle of Clinical Laboratory
Testing
QUALITY CONCEPTS
QUALITY CONTROL

• Study of those errors which are the responsibility of the laboratory

and the procedures used to recognize and minimize them.
• A system of ensuring accuracy and precision in the laboratory.
• A process of ensuring that analytical results are correct by testing
known samples that resembles patient samples.
Kinds of Quality Control

1. Intralab (Internal QC)

• Involves the analyses of control samples together with the patient
specimen
• Detects changes in performance between the present operation and the “
stable” operation
• Important for the daily monitoring of accuracy and precision of analytical
methods

2. Interlab (External QC)

• Involves proficiency testing programs that periodically provide samples of
unknown concentration of analytes to participating laboratory
• Important in maintaining long-term accuracy of the analytical methods
• Used to determine estimates of the state-of the-art interlaboratory
Quality Assurance
• Overall activities conducted by the institution that are directed toward assuring the quality of se
rvices provided
• Focused on the recipient-patient
• Focuses on monitoring the outcomes or indicators of care.
Concept of Error

RANDOM ERROR
• Present in all measurement; it is due to chance, can be both positive or
negative
• Basis for varying differences between repeated measurements
• Due to:
• Instrument, operator and environmental conditions (variations in
techniques)
• Pipetting errors
• Mislabelling of samples
• Temperature fluctuation
Concept of Error
SYSTEMATIC ERROR
• Error that influences observations consistently in one direction
(constant difference)
• Detected as either positive or negative bias; often related to
calibration problems, failing instrument and poorly written
procedures
NEXT TOPIC:

CPD and ETHICS