Clinical laboratory science is crucial to the

practice of modern medicine. Data from

clinical laboratories is used by:

􀂃 Physicians to make accurate diagnoses.

􀂃 Nurses, pharmacists, and other health
professionals to plan or implement
patient treatment and care.
Laboratory Workflow:

The clinical lab’s role is to:

1. collect specimens
2. perform tests
3. report the results.
1 = Doctors
order/ request

6 = Report results to 2 = collect & label

doctor (result form) patient sample

5 = Analyze / test 3 = Deliver sample

sample to laboratory

4 = Process
sample
LABORATORY ORGANIZATION
•Administrator (Medical Director)
•The Head Pathologist
•The Chief Medical Technologist
•The Section Head
•The Senior Medical Technologists
•The Junior Medical Technologists
•The Medical Technicians
 Administrator
•  medical director 
–  It is largely a generic term used to describe a
physician who has responsibility for the medical
control and direction of various types of
organizations, including hospital departments, 
blood banks, clinical teaching services and others.
– is a physician who provides guidance, leadership,
oversight and quality assurance for the practice of
local paramedics and EMTs (Emergency medical
technician) within a predefined area.
 Pathologist
• Pathologists are doctors who diagnose and
characterize disease in living patients by
examining biopsies or bodily fluids.
• Pathologists also interpret medical laboratory tests to
help prevent illness or monitor a chronic condition.
• Laboratory Director
– Has ultimate responsibility for all laboratory operations
• As Head of medical laboratories, pathologists play an
important role in the development of laboratory
information systems.
Technical Supervisor or Laboratory Manager

• Directly under the laboratory director’s authority

• Someone educated in the medical laboratory sciences who
has additional business or management skills

Chief Medical Technologist

• Functions in supervisory, administrative, and technical analytical work in
performing standardized or highly specialized tests and examinations in a
clinical laboratory.
• Work involves supervising a group of technologists and technicians in the
performance of a variety of standard serological, biochemical, histological,
and hematological laboratory examinations and tests and specialized tests
and re-tests where abnormal or atypical results were obtained.
 DUTIES AND RESPONSIBILITIES
• Is responsible for day to day operation of the laboratory.
– supervises and participates in the performance of all standard clinical
laboratory tests and procedures
• Is responsible for setting personnel standards, establishing
training and evaluation procedures, establishing appropriate
Quality Assurance Programs, observing & documenting
employee performance and competence.
• Is responsible for making available to all personnel an up to
date procedure manual containing instructions for every
procedure performed in the laboratory.
– Procedure Manual must follow the standard set by NCCLS
– NCCLS =National Committee for Clinical Laboratory Standards
 Other Roles:
• provides clerical, supply, and administrative support
required in laboratory administration.
• arranges schedules for subordinate technicians
• assists in revision of methodology
• supervises the maintenance of laboratory records and
reports.
• Participates in the selection and training of personnel
• orders supplies.
General Supervisor / Department or Section
Head
• Each department has a department head,
whose responsibility is to:
– Check & supervise the quantity & quality of work
performed in his/her department.
– Training employees (new)
– Evaluating employee performance
– General supervisor / Department Head reports to
Technical Supervisor
 Testing Personnel or
Bench Technologist
• Performs laboratory analyses
• Includes:
– Medical Scientists / Technologists (Senior and
Junior)
– Medical Laboratory Technicians
– Non laboratory Personnel such as medical
assistants and nurses that performs test in POL
(Physicians Office Lab) or other settings outside
the laboratory.
CLIA ‘88 Job Title Current Equivalent Job Title
Laboratory Laboratory Director (usually a pathologist)
Director
Technical Laboratory Manager (Chief Med tech)
Supervisor
Technical Department Head, Section Head, Section
Consultant or Supervisor, Technical Specialist
General
Supervisor
Testing Personnel Bench Technologist, Medical Technologist,
Clinical Laboratory Scientist, Medical
Laboratory Technician, Clinical Laboratory
Technician, Laboratory Assistant

CLIA ‘88 = Clinical Laboratory Improvement Amendments of 1988

• IMPORTANT NOTE:

–The more complex the test, the

more highly trained the testing
personnel must be.
 ADMINISTRATOR

PATHOLOGIST

LABORATORY MANAGER
OR
CHIEF TECHNOLOGIST

ASSISTANT
LABORATORY MANAGER

HEMATOLOGY CHEMISTRY BLOOD BANK MICROBIOLOGY SPECIMEN COLLECTION

Blood & urine Body fluids MICROBES AND PROCESSING

BLOOD
BANK
ROUTINE ROUTINE (Storage & BACTERIOLOGY
HEMATO- CHEMISTRY X-matching
LOGY

COAGULATION Immunology
SPECIAL &SEROLOGY PARASITOLOGY
CHEMISTRY (Antibodies)

URINALYsis
ORGANIZATIONAL CHART OF A TYPICAL MEDICAL LABORATORY Walters,et al.,1986, ch 1p 5
 HOSPITAL ADMINISTRATOR

Laboratory Director (Pathologist)

Assistant Laboratory
Laboratory Manager or Technical Manager (Assistant
Supervisor Technical Supervisor)

Urinal Coagu Blood Specimen Microbi Quality

POCT Hematology ysis
Chemistry lation Collection & Assura
Bank ology
Processing nce
(Accessioning
)

Routine Myco Viro

Routine Blood logy logy
Hematology Chemist bank
ry
Special Special Serology Bacte Para
Hematology Chemistry riolo Sito
gy logy

Organizational Chart of a Typical Hospital Laboratory

(CLIA ’88)
Departments of the Medical Laboratory
• The number of departments in a laboratory varies
• Departments:
– Clinical Chemistry
Usually operates as
– Hematology department or
– Microbiology section, each with its
own department
– Blood Bank head
– Specimen Collection & Processing
• Subdivision within each laboratory differ from each other
• Large Laboratories:
– separate departments for urinalysis, coagulation, serology,
parasitology, Quality assurance and off-site testing.
Responsibilities of Each Unit/Area:
1. Quality Assurance:
- Responsible for coordinating Total Quality Management (TQM)
or Quality Assurance (QC) for all sections of the laboratory
(Procedures, Specimen Processing, Reporting)
- Management of off-site testing
- Personnel training
- Updating procedure manual
- Monitoring compliance with regulatory agencies
- Record keeping
- Documentation of equipment maintenance, calibration &
repairs and participation in proficiency training
 Responsibilities of Each Unit/Area:
2. Specimen Collection & Processing (Accessioning)
- Phlebotomy department (Phlebotomist)
* Small Lab:
- specimens are taken directly by the appropriate
department for testing.
* Large Lab:
- specimens are taken to a central accessioning area
where they are processed, logged into the computer,
given specimen number before distribution to the
different departments.
 Responsibilities of Each Unit/Area:
3. Microbiology
– Responsible for culturing & identifying microorganisms (bacteria)
isolated from patient’s clinical specimen.
– receives almost any clinical specimen
• swabs, feces, urine, blood, sputum, cerebrospinal fluid, synovial
fluid, as well as possible infected tissue.
– After identification....Sensitivity testing is carried out to determine
which antibiotic is the most effective in treating the infection.
• sensitive or resistant to a suggested medicine.
– Results are reported with
• Identity of the organism(s) and
• type and amount of drug(s) that should be prescribed for the patient.
• Traditional Microbiology Lab = less automated
• Big laboratories = performs automation in microbiology (API=
Analytical Profile Index)
 Different types of culture media:
• Solid
– Plate or tube
• Semi-solid
– tube
• Liquid
– tube
 A plastic strip holding
twenty mini-test tubes is
inoculated with a saline
suspension of a pure
culture

Cultu O A L O C H U T I V G G M I S R S M A A Identification
re # N D D D I 2 R D N P E L A N O H A E M R
P H C C T S E A D L U N O R AC L Y A
G
8030 + - + - + - + - - + _ + + + + + + + + + Klebsiella pneumoniae

8068 - - - - - + + + + - + + - - - - + - + - Proteus vulgaris

8P14 - - + + - + - - - - _ + + - + + - + - + Salmonella spp.
• Virology 
– study of viruses PART OF MICROBIOLOGY
• Mycology  LABORATORY
– Study of fungi
• Parasitology 
– is a microbiology unit that investigates parasites.
– The most frequently encountered specimen is feces.
– However, blood, urine, sputum, and other samples may also contain
parasites.
– Examination of blood for malarial parasite is performed in the Hema
section.
– In the Phil.... Parasitology is performed in the Clinical Microscopy section
(examinations of urine & feces are done)
 Responsibilities of Each Unit/Area:
4. Blood Bank
- AKA: Transfusion services or Immunohematology
- Determination of ABO group and Rh blood type
- Determination of blood compatibility (between donor &
patient) prior to transfusion.
- processing donated blood into specialized component such as
platelet, PRBC, FFP

• Regulated by the FDA since giving blood is considered a drug,

– this unit determines a patients blood and rh type, checks for antibodies to common
antigens found on red blood cells, and cross matches units that are negative for the antigen.
• Immunology/Serology 
– Subdivision of blood bank and microbiology
department (not a separate department)
– Serum is the specimen of choice
– uses the concept of antigen-antibody interaction
as a diagnostic tool.
– Performed tests:
• Pregnancy, arthritis, HIV, Hepatitis, sexually transmitted
diseases (syphilis), & other infectious diseases.
– Compatibility of transplanted organs is also
determined.
Responsibilities of Each Unit/Area:
5. Hematology
– Involves tests for studying the cellular components of the blood.
– works with whole blood to do full blood counts, and blood films as
well as many other specialised tests.
– Do Qualitative & Quantitative Tests
• QUALITATIVE:
– Observe for the qualities of the blood components (cell size, shape & maturity)
– Microscopic examination of blood smear
• quantitative tests
– counting blood components = WBC, RBC, Hgb, Platelets
– Can be manual or automated
– Can help diagnose anemia, infection & other blood related problems
• Coagulation 
– Performed in the hematology section or in large lab it is
a separate department.
– Coagulation tests are performed to diagnose & monitor
patients who have defects in their blood clotting
mechanism or are being treated with anti-clotting drugs.
– Plasma, the liquid portion of anticoagulated blood is the
specimen used.
– Laboratories used automated coagulation testing system
– Some used manual method like...bleeding time &
clotting time
• Urinalysis
– Maybe a separate department or maybe a
subdivision of another department (Hematology
or Chemistry)
– Physical, Chemical & Microscopic examination of
urine specimen are performed
– Maybe performed manually or automated
methods.
Physical Examination of Urine
• Volume
– NV of an early morning mid–stream sample is 50 –
300ml.
– If it is more than 500ml, it indicates diabetes or polyuria
– If it is less than 20ml, it indicates some kidney disorder.

• Color
– The normal color of urine is pale yellow.
– Idark yellow to orange = liver disorder.
– Iwhite = presence of pus.
– pink to red = presence of red blood cells.
– brownish black = presence of melanin or homogenistic
acid (a rare disorder).
– If it is blue to green = liver disorder.
– Sometimes, due to the intake of some food or medicines
• Appearance
– Clear to cloudy.
– turbid due to the presence of
WBCs (White Blood Cells),
epithelial cells.
– hazy due to mucus.
– Smoky, due to red blood cells.
– Milky due to chyle (lymph).
• Reaction
– Usually acidic pH range 4.5 – 7.5.
• Odor
– aromatic in normal conditions.
– It has a fruity odor in diabetes.
– Ammoniacal odor in cases of
urine retention.
– Foul smelling due to UTI
• Sediment formation at the
bottom of a container after
collection
– Usually, there is no or very little
formation of sediment in normal
conditions.
– If pus cells, red blood cells, cysts or
epithelial cells are present, the
sedimentation rate ranges from
moderate to high.
• Specific Gravity
– Usually varies from 1.003 to 1.060.
– A low specific gravity indicates
diabetes insipidus or kidney infection
(chronic).
– High specific gravity indicates
diabetes mellitus or acute kidney
infection.
Chemical Examination of Urine
• Protein
– Normally absent.
– Present in kidney disorders,
dehydration, heart disease, and
severe diarrhea.
– Sometimes, due to an excessive
muscular exercise, prolonged cold
baths, excessive protein intake or
vaginal discharge in the urine, the
test shows the presence of protein.

GlucoseUrine Chemical Analyser

– Normally absent.
– If present, it indicates diabetes
mellitus or hyperactivity of the
endocrine glands.
– It can be present after brain injury or
coronary thrombosis.
• Ketone bodies • Urobilinogen
– Normally absent.
– Normally present in very
– If test shows ketones, it is due
low concentrations.
to severe diabetes mellitus,
fevers, certain nervous – Increased in liver disorders.
disorders or prolonged diarrhea
and vomiting.
• Blood
– Even when a person starves,
the urine shows a presence of – Normally absent.
ketone bodies. – Present in acute kidney
• Bile pigments infections, kidney cancer,
– Normally absent. tuberculosis of the kidneys,
– Present in liver disorders. chronic infections, stone
• Bile salts formation in the kidneys,
severe burns or a reaction
– Normally absent.
to blood transfusion.
– Present in liver disorders.
 Microscopic Examination of Urine
• Pus Cells
– Normally 2 to 3 pus cells are present in HPF (high
power field of microscope).
– If more than 5 it indicates urinary tract infection
or non infectious condition such as fever, stress,
dehydration irritation to urethra, bladder or
urethra.
• Epithelial cells
– Normally two to three present in males.
– Normally two to five present in females.
– More than five epithelial cells per HPF indicates
tubular damage, pyelonephritis or kidney
transplant rejection.
• CastsGranular cast in urine
– Normally absent.
– There are hyaline cysts, red cell cysts, white cell
cysts, granular cysts, waxy cysts, and fatty cysts.
They are present due to kidney disorders.
– Occasional Hyaline cysts may be present due to
physical exercise and physiological dehydration.
– Granular cysts may be present after strenuous
exercise for a short duration.
• Amorphous Material
• Unusual fine sheaves of Calcium Phosphate
–Amorphous urates of sodium, potassium or calcium are present
normally.
–Amorphous phosphates of calcium and magnesium are present
normally.
• Crystals
–Uric acid, calcium sulphate, calcium oxalate and ammonium
magnesium phosphate (triple phosphate) crystals are indicative
of the presence of kidney stones.
• Hippuric acid, calcium carbonate, ammonium biurate and
calcium phosphate crystals
–are non–significant.
• Following crystals, found in acidic urine indicate abnormal
metabolism – cystine, cholesterol, leucine, tyrosine,
bilirubin, hematoidin and sulphonamides.
• Ammonium Biurate
• Bacteria
–Normally absent.
–If present indicates infection.
• Yeast cells
–Normally absent.
–May be present in acidic urine containing sugar.
• Parasites
–Normally absent.
–If present, they are Trichomonas Vaginalis (from vagina) or
Trichononas Hominis (from rectum).
Laboratory equipment for hematology (black analyser)
and urinalysis  (left of the open centrifuge).
Responsibilities of Each Unit/Area:
6. Clinical Chemistry 
– The largest department in most lab. (w/ subdividions)
• Divisons: Special Chemistry & Toxicology
– usually receives serum (the liquid part of blood remaining after
a clot has formed)  
• Plasma, urine, and other body fluids (CSF, synovial fluid)
– Test the serum for chemicals present in blood.
– Procedures performed:
• Blood glucose, cholesterol, assays of heart, liver enzymes &
electrolytes ( Na, Cl, K)
– These include a wide array of substances, such as lipids, blood
sugar, enzymes, and hormones.
• Toxicology 
– Tests for pharmaceutical and recreational drugs. 
• To detect possibility of substance/drug abuse
– Urine and blood samples are submitted to this lab.
• Special Chemistry (Endocrinology)
– Performs tests to assess the function of the endocrine
system and its specific secretions called hormones.
– This is a subsection of chemistry that quantitates
various hormones such as insulin, thyroid hormones,
cortisol, growth hormones and others.
 Ex. Thyroid hormones
• The thyroid hormone:
– thyroxine (T4) and triiodothyronine (T3),
• are tyrosine-based hormones
• produced by the thyroid gland primarily responsible for regulation of metabolism.
• An important component in the synthesis of thyroid hormones is iodine.
• Function of thyroid hormones
– are essential to proper development and differentiation of all cells of the human body.
– These hormones also regulate protein, fat, and carbohydrate metabolism, affecting
how human cells use energetic compounds.
– They also stimulate vitamin metabolism.
• Abnormality:
– If there is a deficiency of dietary iodine,
• the thyroid will not be able to make thyroid hormone.
• The lack of thyroid hormone will lead to decreased negative feedback on the pituitary,
• leading to increased production of thyroid stimulating hormone, which causes the thyroid to
enlarge (goiter)endemic colloid goiter.
• This has the effect of increasing the thyroid's ability to trap more iodide, compensating for the
iodine deficiency and allowing it to produce adequate amounts of thyroid hormone.
 Ex. Insulin
• Insulin
– hormone that is important in regulating energy and glucose metabolism in the body.
– Insulin causes cells in the liver, muscle, and fat tissue to take up glucose from the blood,
storing it as glycogen in the liver and muscle.
• Insulin stops the use of fat as an energy source.
– When insulin is absent, glucose is not taken up by body cells and the body begins to use fat
as an energy source.
• = ketoacidosis
– is a type of metabolic acidosis associated with high concentrations of ketone bodies, formed by the breakdown of fatty
acids and the deamination of amino acids.
– Ketoacidosis is a pathological metabolic state marked by extreme and uncontrolled ketosis.
» Normal ketosis is induced by prolonged fasting or a low-carbohydrate diet
– In ketoacidosis, the body fails to adequately regulate ketone production causing such a severe accumulation of keto
acids that the pH of the blood is substantially decreased. In extreme cases ketoacidosis can be fatal.

• When control of insulin levels fails

– diabetes mellitus will result.
• Type 1 diabetes mellitus depend on external insulin (most commonly injected subcutaneously)
– results from autoimmune destruction of insulin-producing beta cells of the pancreas
• Type 2 diabetes mellitus or non-insulin-dependent diabetes mellitus (NIDDM) or adult-onset diabetes 
– is a metabolic disorder that is characterized by high blood glucose in the context of insulin resistance and relative
insulin deficiency.
– Diabetes is often initially managed by increasing exercise and dietary modification. As the condition progresses,
medications may be needed.
7. Point of Care Testing (POCT)
- one of the major changes occurring in the clinical lab today
*due to the evolution of small, simple to use analyzers that requires
only tiny amt of specimen has led to widespread of POCT
implementation.

- AKA: bedside testing, near patient testing, off-site testing, or alternate

site testing.

- POCT brings the laboratory test to the patient rather than obtaining a
specimen from the patient & sending it to the lab for testing.
* Advantage: The turn over time for lab results is faster = improved
patient care

- POCT is used in settings like:

* Nursing home, Physicians office, Emergency room, ICU, Surgery
suites.
Responsibilities of Each Unit/Area:
OTHER SPECIAL AREAS IN THE LAB:
• Histopathology
– processes solid tissue removed from the body (biopsies) for evaluation
at the microscopic level.
* Surgical pathology
• examines organs, limbs, tumors, fetuses, and other tissues biopsied in surgery
such as breast mastectomys.
• Biopsy or autopsy

• Cytopathology
– examines smears of cells from all over the body (such as from
the cervix) for evidence of inflammation, cancer, and other conditions.
Responsibilities of Each Unit/Area:
• Electron microscopy 
– prepares specimens and takes micrographs of very fine
details by means of TEM and SEM.
• Genetics 
– mainly performs DNA analysis.
• Cytogenetics 
– involves the use of blood and other cells to get a karyotype.
– This can be helpful in prenatal diagnosis (e.g. Down's
syndrome) as well as in cancer (some cancers have
abnormal chromosomes).
 PROFICIENCY TRAINING
• CLIA ’88 requires the laboratories performing
moderate or high complexity testing to:
– Participate in an approved proficiency testing program
(SACCL – HIV; RITM – MICRO; UP- PARA)
– Laboratories are checked for QC
• Samples are sent to the lab for analysis at regular interval
• After testing the lab will report to the proficiency testing
agency for evaluation of accuracy in identification / testing
• Advantage:
– creates more confidence
– Identify deficient areas
– Improves laboratory performance
 Accreditation of Medical Laboratories:
• Accreditation = is a voluntary process in w/c an independent
agency grants recognition to institution or programs that
meet or exceed established standards of quality
• Accrediting Agencies:
– JCAHO (Joint Commission on Accreditation of Health Care
Organizations)
• Accredits hospitals
– CAP (College of American Pathologists)
• Accreditation to medical laboratories
– AABB (American Association of Blood Banks)
• Accredits blood bank departments
– COLA (Commission on Office Laboratory Accreditation)
• Accredits Physician Office Laboratories
 ISO = most hospitals in the Phil.
• International Organization for Standardization 
• an international-standard-setting body composed of
representatives from various national standards
organizations.
• Founded February 23,1947
• headquarters in Geneva,Switzerland.
•  ISO is not an acronym  for the organization's full name
– based on the Greek word isos, meaning equal.
• In reflects of the aim of the organization:
– to equalize and standardize across cultures