SPECIAL CLINICAL LABORATORIES

THE CLINICAL LABORATORY  Provides highly specialized lab services not provided by a
general clinical laboratory

CLINICAL LABORATORY NATIONAL REFERENCE LABORATORY

 facility subdivided into different sections where common  laboratory in a government hospital which is designated to
diagnostic procedures are done by specialized health provide special functions and services such as:
professionals o testing
o Confirmatory Surveillance
 Regulated by the Bureau of Health Facilities and Services
o Resolution of conflicts
under DOH which prevents the operation of substandard
o Training and research
 Essential component of health institutions o Evaluation of kits and reagents
o External quality assessment program
NRLS IN THE PHILIPPINES
 provide accurate and reliable information to medical
 National Kidney and Transplant Institute:
doctors for the diagnosis, prognosis, treatment, and
management of the diseases.  Hematology, Immunohematology, Automated
Urinalysis, Immunopathology
 East Avenue Medical Center:
 place where specimens collected from individuals are  Toxicology
processed, analyzed, preserved, and properly disposed  Lung Center of the Philippines:
 Clinical Chemistry
BASED ON OWNERSHIP  Research Institute for Tropical Medicine
 GOVERNMENT  Tuberculosis, Mycology, Transfusion-
 Operated and maintained by a government unit transmissible infections, Bacterial Diseases,
 PRIVATE Antimicrobial Resistance, Influenza, Malaria,
 Owned, operated, and established by any individual, Measles and other exanthems, Rotavirus, Polio
corporation, association, or organization  San Lazaro Hospital/STD-AIDS Central Cooperative
Laboratory:
BASED ON FUNCTION  HIV/AIDS and other sexually-transmitted
 Clinical Pathology infections
 Focuses on the areas of Clinical Chemistry,
Immunohematology and Blood Banking, Medical SATELITTE TESTING SITE
Microbiology, Immunology and Serology,  testing site that performs lab examinations under the
Hematology,Parasitology, Clinical Microscopy, control of a licensed laboratory but outside the physical
Toxicology, Therapuetic Drug Monitoring and confines of the laboratory
Endrocrinology
MOBILE CLINICAL LABORATORY
 Concerned with the diagnosis and treatment of  A laboratory testing unit that moves from one testing site to
diseases performed through laboratory testing of blood another
and other body fluids  Must have a base laboratory
 Must collect specimens only
 Anatomic Pathology  Must operate only within a 100-km radius from its base
 Focuses on the areas of Surgical Pathology, laboratory
Immunohistopathology, Cytology, Autopsy, Forensic
Pathology, Molecular Pathology SECTIONS IN THE LABORATORY
 Clinical Chemistry
 Concerned with the diagnosis of diseases through  Performs a wide variety of tests using the most
microscopic examination of tissues and organs current technology.
 It is defined as the scientific study of matter and
BASED ON INSTITUITIONAL CHARACTER the various compounds of the elements as it
 Institution – based relates to the human body.
 Operates within the premises or part of an institution
such as hospital, school, medical clinic, medical  Common tests analyzed in the chemistry
facility for overseas workers and seafarers, birthing laboratory are glucose, cholesterol, BUN,
home, psychiatric facility, drug rehabilitation center. creatinine, potassium, liver and heart enzymes,
thyroid tests and hormone tests, and PSA.
 common example: HOSPITAL-BASED CLINICAL  Clinical Chemistry is fully automated with advanced
LABORATORIES technology, high throughout analyzers which use the
present methodologies for all testing.
 Freestanding  offers a comprehensive range of testing in areas of
 laboratory that does not form part of any other o 1.1 Routine general chemistry
institution o 1.2 Specific protein chemistry include cardiac
 Common example: OUT-PATIENT CLINICAL marker and others
LABORATORY o 1.3 Immunology include endocrines, infectious
markers, cancer markers
BASED ON SERVICE CAPABILITY o 1.4 Therapeutic drug monitoring and drug abuse
 Primary: 10 sq. m. (minimum space required)
o Routine Hematology  HEMATOLOGY
o Routine Urinalysis  Performs a wide range of tests from basic blood
o Routine Fecalysis cell count to routine
o Qualitative Platelet .
o Blood typing (hospital based)  The Full Blood Count is performed on our
 Secondary: 20 sq.m.( minimum space required) automated hematology analyzer which provides
o All tests in primary lab information on the quantity and quality of
o Routine Chemistry platelets, red and white blood cells.
o Quantitative Platelet
o Cross-matching; Gram staining; KOH  This information aids in the diagnosis of
(hospitalbased) conditions such as anemia, thalassemia, leukemia
 Tertiary: 60 sq. m. and infections, particularly dengue.
o All tests in secondary lab
o Special Chemistry  Selected film with significant abnormal results or blood
o Special Hematology film finding based on the results obtained and clinical
o Immunology-Serology history of the patient, a blood film is made and reviewed
under the microscope for final reporting.
o Microbiology
o 2.1 Full complete blood count
 Limited Service Capability
o 2.2 Leukemia – special staining
o Dialysis centers
o 2.3 Parasites- malaria, microfilaria
o Social hygiene clinics
 COAGULATION
  Our Coagulation Section provides services to access  Blood transfusion protocols are established to ensure the
patient’s hemostasis status which is particularly orderly and accurate processing and issuance of blood
important for patients on anticoagulant therapy. products.
Besides that, special coagulation tests for examples o 7.1 ABO and Rh Type
o 3.1 Lupus Anticoagulant
o 7.2 Antibody screening, identification
o 3.2 Protein C, Protein S,
o 3.3 Anti thrombin III o 7.3 Cross matching and direct anti-
o 3.4 Fibrinogen globulin test
 CLINICAL MICROSCOPY  HISTOPATHOLOGY
 Performs scientific analysis of non-blood body  Surgical Pathology
fluids such as urine and stool. o 7.3 Cross matching and direct anti-
globulin test
 The macroscopic, chemical and microscopic
 Cytology
examinations of urine provide initial valuable
o a skilled cytotechnologist examines
diagnostic information concerning metabolic
human cells under the microscope,
dysfunctions of both renal and non-renal origin.
looking for early signs of cancer and
other diseases. The most common type
 Analysis of stool samples such as occult blood
of specimen processed in the Cytology
determination and stool examination for fats help
department is the Pap smear.
clinician in early detection of gastro-intestinal
bleeding, liver and biliary duct disorders and mal
 SPECIAL LABORATORY
absorption syndrome.
 The Special Laboratory performed using a wide
 Parasite identification and assessment of the extent of
variety of methodologies and testing from basic
parasitism are also performed in this section.
to advance technology.
o 4.1 Urinalysis
 This department has more than 10 automated
o 4.2 Stool examination
analyzer for all testing.
o 4.3 Parasites
 The Special Laboratory supports physicians by
o 4.4 Body fluid analysis performing testing services for diagnostic and
therapeutic evaluations.
 MICROBIOLOGY  This teams consists of highly experienced
 Microbiology is the study of microorganisms medical technologists and other specialists all
including algae, bacteria, fungi, protozoa and viruses. working collaboratively
 Any bodily fluid or tissue can be cultured for
infectious disease.  The Department offers a comprehensive range of testing in
areas of
 Once bacteria grows in culture, it can be tested against o 9.1 Autoimmune diagnostics
many different antibiotics to find the most effective o 9.2 Allergy testing
for fighting the infection while limiting opportunities o 9.3 Prenatal for Down
for antibiotic resistance.
syndrome ,Trisomy 18 and NTD
o 9.4 New born screening
 Performs a wide variety of microbiological testing.
o 9.5 Thalassemia
 Microbiology culture employs the conventional o 9.6 Liver fibrosis
methods with current technology to isolate the o 9.7 Free radical and antioxidant
causative agent of infection. o 9.8 Neurological disease and
Alzheimer's testing
 Accurate and relevant results in microbiology depend o 9.9 Infectious antigen and antibody
on both the doctor and the laboratory. o 9.10 Endocrine testing
 Submission of the best specimen type for a particular LABORATORY TESTING CYCLE
test or recovering a specific microorganism is of  Consists of all steps between the time when a clinician
importance for a successful outcome. thinks about and orders a laboratory test and the time the
appropriate patient’s sample for testing is obtained (eg, a
 Factors contributing to the successful isolation of potential
pathogens include specimen selection, quality, collection, blood specimen taken from an antecubital vein) and the
results of the testing are returned to the clinician (often
and transportation to the laboratory.
o 6.1 Culture identification by manual and called the “vein-tobrain” turnaround time [TAT] of test
results).
automation
o 6.2 For bacterial identification
o 6.3 Antimicrobial susceptibility testing  This cycle consists of 3 phases: preanalytic, analytic, and
o 6.4 AFB for all Mycobacterium tuberculosis and post-analytic
Non tuberculosis mycobacterium (NTM).
o 6.5 Drug sensitivity testing to provide first-line 3 PHASES OF THE TESTING PROCESS
drugs.  Pre-analytic
 refers to all the activities that take place before
 IMMUNOLOGY AND SEROLOGY testing such as ordering and sample collection
 Immunology is the study of immune products  Analytic
such as antibodies produced by the body in  consists of the laboratory activities that actually
response to foreign material. produce a result, such as running a sample on an
automated analyzer
 BLOOD BANKING  Post-Analytic
 Blood bank Section performs the compatibility  comprises patient reporting and result
between the patient requiring transfusion and the interpretation
unit of blood to be transfused.
QUALITY ASSURANCE
 Patient samples are tested for ABO and Rh Type,  Planned and systematic activities to provide adequate
antibody screening, cross matching and direct confidence that requirements for quality will be met. It is
anti-globulin test also a measurement of the broader dimension of quality
from the perspective of the end-user (Bishop, 2010, 6 th
 Provides blood transfusion support by providing ed.)
the patient with red cells, plasma, cryoprecipitate,  Program development
or platelets.  Assessment & Monitoring
 Quality improvement (QC)
 Testing is performed on the patient’s blood
specimen prior to transfusing to make sure QUALITY IMPROVEMENT (QC)
compatible blood is give  External QA
 Proficiency testing
 Blood products
  Blind Testing
 Internal QA

QUALITY CONTROL
 Systematic monitoring of the analytic processes in order to
detect analytic errors that occur during analysis and to
ultimately prevent the reporting of incorrect patient test
results. (Bishop, 2010, 6th ed.)
 A testing designed to assess the health of an analytical
method. (Henry’s, 20th ed.)

Why?
 Error Detection
 Error Prevention
 Measure Performance (Bias, Imprecision, Total Error)
 Monitor Performance
 Validate Performance

How?
 Application of Statistical Concepts
 Central Tendency (Mean, Median, Mode)
 Range
 Standard Deviation
 Coefficient Variance

 Application of multirole systems

 Westgard Rulings
 Plotting data
 Levey-Jennings Chart

CALIBRATION VS. QUALITY CONTROL

 Calibration
 “setting” the analyser to give correct results; uses
calibrators (standards)
 Quality Control
 “checking” if the analyser is producing correct
results, the instrument’s calibration and other
analytical processes

STANDARD VS. CONTROL

 Standard
 solution that contains a known amount of an
analyte used to calibrate an assay method
 single substance with known concentration
 run prior to QC manually or automatically by the
microprocessors controlling the instruments
 for calibration
 Control
 solution or serum in which the analyte has the
same matrix as the specimen being used to
monitor the performance of an assay method
once it has been calibrated
 multiple analytes
 run along-side patient samples and results are
calculated from calibration data as the same
manner that patient results are calculated
 for QC

WHEN TO CALIBRATE?
 Newly purchased initial set-up
 After repair
 At manufacturer’s recommendation
 When a test method has a problem

WHEN TO RUN QUALITY CONTROL?

 If patient results are questionable
 After instrument/ calibration
 With new lot number of reagents/ control