Nature of Clinical

Laboratory
Mr. Mark Kerwin F. Sayas, RMT, MSMLS, DTA
Ms. Sharon Hazel Joyce Sebastian, RMT
Charlie P. Cruz, PhD, RMT, CLS, MLS (ASCPi)CM
Course Instructors
 Clinical Laboratory
● Facility that is involved in
○ Pre-analytical
○ Analytical
○ Post Analytical
● Tests are done on specimens from human body to obtain information about
the health status of a patient for
○ Prevention

○ Diagnosis

○ Treatment of diseases
Clinical Laboratory
● Anatomic Pathology
● Clinical Chemistry
● Clinical Microscopy
● Endocrinology
● Hematology
● Immunology and Serology
● Microbiology
● Toxicology
● Molecular Diagnostics
● Nuclear Diagnostics
Clinical Laboratory is also active in
● Research
● Community Outreach
● Surveillance
● Infection Control
● Information Dissemination
● Evaluation of the applicability of
diagnostic technologies
Laboratory Assays
• In the past were described as manual, taxing, labor
intensive and time consuming

• Today assays are less laborious, shortened

turnaround time (TAT), more reliable results
 Classification of the Clinical Laboratory

Ownership Institutional Character

● Government ● Institution-based
○ Philippine General ○ Philippine General
Hospital Hospital
○ Batangas Medical Center ○ Batangas Medical Center
○ St. Luke’s Medical Center
● Private ○ Asian Hospital and
○ St. Luke’s Medical Center Medical Center
○ Asian Hospital and
Medical Center ● Non-Institution Based
○ Hi-Precision Diagnostics
 Classification of the Clinical Laboratory
Clinical Pathology
• Deals with chemical and
cellular analyses of blood
and other body fluids.
• Clinical chemistry
• Clinical Microscopy
• Toxicology
• Therapeutic Drug
Monitoring
• Immunology/Serology
• Hematology
• Coagulation
• Microbiology
• Parasitology
Anatomic Pathology
• Provides processing and
examination of surgical
specimens as to the physical
appearance and microscopic
structure of tissues
• Surgical pathology
• Cytopathology
• Immunohistochemical
techniques
• Autopsies
• Forensic pathology
Molecular Pathology
• Deals with the analysis of
certain genes, proteins and
other molecules in sample
from organs, tissues of
bodily fluids in order to
diagnose disease and/or to
guide the prevention and
treatment of disease
 Service Capability
Section Primary Laboratory Secondary Laboratory Tertiary Laboratory
Clinical Microscopy • Urinalysis
• Fecalysis
• Fecal Occult Blood
• Pregnancy Test
• Wet Smear for
Trichomonas
Clinical Chemistry • Fasting Blood Sugar • Serum Electrolytes (Na, • Other clinical chemistry
• Random Blood Sugar K, Ca, Cl) examinations
• Oral Glucose Tolerance • ALT/SGPT
Test • AST/SGOT
• Lipid Profile
• Creatinine
• Blood Urea Nitrogen
• Blood Uric Acid
 Service Capability
Section Primary Laboratory
Hematology • Complete Blood Count
• Reverse and Forward
Blood Typing
Serology/Immunology • Dengue
• Syphilis
• Hepatitis B Screening
• HIV Screening
Microbiology • TB (DSSM) or Nucleic
Acid Amplification (for
government facilities)
Anatomic Pathology
Secondary Laboratory Tertiary Laboratory
• Coagulation studies
(PT, aPTT)
• Any machine-based
serological and
immunological tests
such as but not limited
to tumor markers,
thyroid function tests
and hepatitis profile
• Gram Stain • Culture and sensitivity
• KOH (Aerobic and
Anaerobic)
• Pap Smear • Cytology and
Histopathology
 Service Capability

Anatomic Pathology Molecular Pathology

● Cytology ● Genetics
● Histopathology ● Immuno/hematopathology
and Infectious Disease
 Laws on the Operation, Maintenance,
and Registration of Clinical Laboratories
in the Philippines
Republic Act 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
 Republic Act 4688
● Section 1 All laboratories shall secure License to Operate Annually
Department of Health (Health Facilities and Services
Regulatory Bureau)
● Section 2 Laboratory shall be headed by Registered Physician (Pathologist)
● Section 3 Department of Health and Bureau of Research and Laboratories
shall be charged with strict enforcing of this act
● Section 4 Any who violates the law shall be punished with
not less than 1 month but not more than one year imprisonment
not less than 1,000 nor more than 5,000 pesos fine
● Section 5 Separability Clause
● Section 6 50 pesos or so much may be necessary is hereby authorized to be
appropriated
● Section 7 Repealing Clause
● Section 8 Effectivity
Administrative Order no. 59 s. 2001
Rules and Regulations Governing the
Establishment, Operation
and Maintenance of Clinical Laboratories in the
Philippines
Administrative Order no. 2007-0027
Revised Rules and Regulations Governing the
Licensure and Regulation of Clinical Laboratories in
the Philippines
Administrative Order no. 2021-0037
New Rules and Regulations Governing the
Regulation of Clinical Laboratories in the
Philippines
Necessary Permits
Staffing
Staffing Pattern for RMT Analysts Based on DOH
AO 2021-0037
Primary Secondary Tertiary
Sections in the Laboratory Laboratory Laboratory
Laboratory 1st 2nd 3rd 1st 2nd 3rd 1st 2nd 3rd
Shift Shift Shift Shift Shift Shift Shift Shift Shift
Clinical Microscopy 1 1 1 1 1 1 1 1 1
Hematology 1 1 1 1 1 1 1 1 1
Clinical Chemistry 1 1 1 1 1 1 1
Immunology/
1 1
Serology 1
Microbiology 1
1
Histopathology 1
Total 12 (11+1reliever)
8 (7+1reliever) without
Without
Microbiology
12 (11+1reliever) Histopathology
9 (8+1) for
13 (12+1) for Hospital
Government
Based
Prototype of Laboratory Blueprint
 Things to consider in the layout of laboratory
Space Area in square meters
General Administrative and Public Areas
Business Area
• Reception Area 5.02 m2/staff
• Waiting Area 0.65 m2/person
Collection Area
• Extraction Area 6.00 m2/chair or couch
• Specimen Collection Toilet 1.67 m2
Public Toilet 3.06 m2
Staff Toilet 1.67 m2
Pathologist Area 5.02 m2/staff
 Things to consider in the layout of laboratory
Space Area in square meters
Support Services Area
Storage Area for Supplies and Records 4.65 m2 or 1.2 m2/storage
unit
Sterilization Unit/Room 4.65 m2
Waste Holding Area 4.65 m2
Staff Pantry 1.40 m2/staff
Conference Room (Optional) 1.40 m2/staff
Laboratory Testing Process
Laboratory Testing Process
 Laboratory Testing Process

Pre-Analytical Analytical Post Analytical

• Test Ordering • Actual Testing • Transmission of
• Receipt of Laboratory • Sampling Methods results/Reporting
Request • Pipetting Techniques • Interpretation of
• Patient Preparation • Quality Control of results
• Specimen Collection reagents and • TAT (turn-around time)
• Specimen transport equipment • Follow-ups
and processing • Personnel competency • Re-Testing
• Test evaluation • Record keeping
 • Wrong values
• Transcription errors
• Transmission errors
• Results given to wrong
patient
• Clerical errors

• Preparation of request slip

• Physiologic factors
• Diet
• Medication
• Physical activities
• Labeling
• Collection errors
• Equipment and instrument • Sample volume
• Reagent quality and • Tubes
quantity • Time of collection
• Internal QC
• Procedural errors
Quality Assurance
• organized, systematic, well planned, and regularly
done with the results properly documented and
consistently reviewed

• involves the entire testing process: pre analytical,

analytical (testing), and post analytical processes
 Quality Assurance
Internal Quality External Quality
Assurance Scheme Assurance Scheme
(IQAS) (EQAS)
● Within the laboratory ● Interlaboratory
● Day to day activity ● AKA: Proficiency Testing
● Uses controls and standards ● Sample (test analytes) from
from the supplier of the National Reference
machine. Laboratories
● Regular review of the reports ● Mandatory to Clinical
Laboratory
 National Reference Laboratories

East Avenue Medical Center

• Environmental and Occupational Health
• Toxicology
• Micronutrient Assay
• Industrial and Chemical Emergencies

Lung Center of the Philippines

• General Clinical Chemistry
• Anatomic Pathology for Pulmonary and Pleural Diseases
 National Reference Laboratories

National Kidney and Transplant Institute

• Hematology
• Immunohematology
• Urinalysis
• Anatomic Pathology for Renal Diseases and Unassigned organ system
• Cellular-Based Product Testing
(AO 2013-0012: Rules and Regulations Governing Accreditation of
Health Facilities Engaging in Human Stem Cell and Cell Based or
Cellular Therapies in the Philippines)

Philippine Heart Center

• Anatomic Pathology for Cardiac Diseases
• Cardiac Markers
 National Reference Laboratories

San Lazaro Hospital – STD AIDS Cooperative

Central Laboratory (SACCL)
• HIV/AIDS
• Hepatitis B and Hepatitis C
• Syphilis and Other Sexually Transmitted Infections
 National Reference Laboratories
Research Institute for Tropical Medicine
• Antibiotic Resistance
• Tuberculosis
• Transfusion-Transmissible Infections
• Dengue and Arboviruses*
• Influenza and Other Respiratory Viruses*
• Emerging and Re-Emerging Bacterial Diseases*
• Leptospirosis*
• Special Pathogens*
• Mosquito Vectors of Human Diseases”
• Malaria and Other Parasites**
• Schistosomiasis**
• Rabies and Other Lyssaviruses**
• Polio and other Enteroviruses
• Measles and Other Exanthems
• Invasive Bacterial Vaccine and Preventable Diseases
• Rotavirus and Enteric Viruses***
• Bacterial Enteric Diseases***
• Mycology
THE END