DIAGNOSTICS CENTER

CLASSIFICATION BY SERVICE CAPABILITY

A. Clinical Laboratory for Clinical and Anatomic Pathology

Primary Category Secondary
Category
Provides the Provides the Provides the Provides one (1)
following minimum minimum service minimum service or two (2)
Service capabilities: capabilities of a capabilities of a specialized tests
primary category secondary that are not
plus the following: category, plus the classified under
following: Anatomic or
- Urinalysis Molecular
- Fecalysis Pathology, as
- Fecal Occult Blood exemplified
Test below:
Clinical
- Pregnancy Test - Hormones
Microscopy
(Rapid Test Kits – - Trace Metals
Lateral Flow) - Tumor
- Wet Smear for Markers
Trichomonas - Allergy Panel
- Fasting and - Serum - Other Clinical
Random Blood Electrolytes Chemistry - This
Sugar (Sodium, Examinations classification
- Oral Glucose Potassium, shall also apply
Tolerance Test Chloride) Hospital-based: to facilities
Clinical - Lipid Profile (Total - ALT Arterial Blood offering DOH-
Chemistry Cholesterol, HDL, - AST Gases program related
LDL, Triglycerides) tests, e.g., Kato
- Creatinine Katz for
- Blood Urea Schistosomiasis
Nitrogen , Malarial
- Blood Uric Acid Smear, Filaria
Hematology - Complete Blood For Hospital-based: Smear, Slit-skin
Count - Coagulation Smear, Rapid
(Hemoglobin, studies Plasma Reagin
Hematocrit, Red (PT, aPPT) for Syphilis
Blood Cell Count,
White Blood Cell
Count with
Differential Count,
Quantitative
Platelet
Count)
- Forward and
reverse ABO
grouping and RH
(D) typing (tube
method)
Serology / - Dengue Any machine-
Immunology - Syphilis based serological
- Hepatitis B and immunological
(Screening) testing such as, but
- HIV (Screening) not limited to:
using Rapid Test tumor markers,
Kit thyroid function
tests and hepatitis
profile
Microbiology - TB (DSSM) or - Gram Stain Culture and
Nucleic Acid - KOH sensitivity (aerobic
Amplification Test and anaerobic)
–
for government
 facilities
Anatomic - Pap Smear For Hospital-
Pathology based:
- Cytology and
Histopathology

B. Clinical Laboratory for Anatomic Pathology only – provides services for any of the
following, but not limited to:
- Cytology
- Histopathology
C. Clinical Laboratory for Molecular Pathology only – provides services for genetics,
immune/hematopathology and infectious diseases

EQUIPMENTS/INSTRUMENTS

A. Primary Category
 Clinical Centrifuge
 Differential Blood Cell Counter
 Hemacytometer
 Hemoglobinometer
 Microhematocrit Centrifuge
 Microscope w/ Oil immersion objective

B. Secondary Category
 All included in Primary
 Photometer
 Refrigerator
 Timer
 Water Bath
C. Tertiary Category
 All included in Primary and Secondary
 Autoclave
 Balance, trip/analytical
 Biological Safety Cabinet
 Drying Oven
 Incubator
 Rotator
 Clinical Centrifuge
ACTIVITY SERVICES GLASSWARE AND
SUPPLIES
SPECIMEN COLLECTION Blood Extraction - 70% Alcohol
Other Body Fluids (Urine, - Cottons
Stool, Sputum, etc.) - Tourniquet
- Lancet
- Capillary Tubes
- Labeling Materials
- Test Tubes
- Sterile Medical Tape
- Syringe and Needle
- Puncture Proof Sharps
Container

- Applicator Stick
- Specimen Container w/ Cover
- Sterile Screw Cap Specimen
Container
- Plastic calibrated loop and
other necessary materials, if
 applicable
OTHER EQUIPMENT - Non-Mercurial Thermometer
- Room and Storage
Refrigerator
- Fire Extinguisher (Class B)
- Spill Kits

SERVICES EQUIPMENT / INSTRUMENT / GLASSWARE / SUPPLIES

Clinical Microscopy
Supplies
- Slides
- Test Tubes
- Test Tube Rack
- Applicator Sticks

URINALYSIS Manual
- Clinical Centrifuge (2000 rpm)
- Microscope (Binocular Compound)

Automated
- Strip Reader
- Urine Analyzer
WET SMEAR for Supplies
Trichomonas - Slides
- Test Tubes
- Cover Slips
STOOL ANALYSIS - Test Tube Rack
- Applicator Stick
- Microscope (Binocular Compound)
PREGNANCY TEST - Pregnancy test kit
FECAL OCCULT BLOOD - Occult blood test kit
Special Tests: For DOH
identified endemic areas only
(e.g., Kato Katz,
Schistosomiasis, Malaria
smear, Filaria smear, slit-skin
smear, rapid plasma regain for
syphilis)
Hematology
Manual
- Spectrophotometer or its equivalent
HEMOGLOBIN
- Curvettes / Test Tubes
- Sahli / Micropipette
Manual
- Hematocrit Centrifuge
HEMATOCRIT - Hematocrit Reader
- Capillary Tube
- Sealer
RED BLOOD CELLS Manual
(optional) - Microscope (Binocular Compound)
WHITE BLOOD CELLS - Pipette Shaker
- Tally Counter
- RBC / Micropipette
PLATELET COUNT
- Counting Chamber w/ Cover Slips
(quantitative)
- WBC / Micropipette
- Petri Dish
Manual
- Differential Counter
DIFFERENTIAL COUNT - Slides
- Staining Glasses
- Microscope (Binocular Compound)
Automated
COMPLETE BLOOD COUNT
- Hematology Analyzer
FORWARD AND REVERSE - Serofuge or its equivalent
ABO GROUPING AND Rh (D) - Test Tubes
TYPING (tube method) Manual
 Semi-automated Machine
Automated
Additional Services for Secondary Category
- Coagulation Machine
COAGULATION STUDIES
- Calibrated Pipette
(for hospital-based)
- Cuvettes or its equivalent
Clinical Chemistry
- Refrigerator
- Clinical Centrifuge
- Water Bath or its equivalent
ROUTINE:
- Calibrated Pipettes
- Blood Glucose (FBS /
- Pipette Tips
RBS / OGTT)
- Other Pipettes
- Total Cholesterol
- Timer
- Triglycerides
- Cuvettes
- HDL
- Test Tubes
- Blood Uric Acid
- Test Tube Rack
- Blood Creatinine
- Blood Urea
Manual
- Nitrogen
- Spectrophotometer or its equivalent

Automated
- Chemistry Analyzer
Additional Services for Secondary Category
Manual
ELECTOLYTES (Na, K, Cl)
Automated Analyzer
AST
ALT
Additional Services for Tertiary Category
Other Clinical Chemistry Manual
Examination
ARTERIAL BLOOD GASES Automated Analyzer
(ABG) (for hospital-based)
Immunology / Serology
- Cuvettes
- Test Tubes
- Test Tube Rack
- Glass Pipettes
BASIC SEROLOGIC - Pipettes & Pipette Tips
TESTING (using Rapid Test
Kits – Dengue, Hepatitis B, Rapid Test Kits
Syphilis, HIV - Dengue
- Syphilis
- Hepatitis B (screening)
- HIV (screening)
- Microscope or Agglutination Viewer
Additional Services for Tertiary Category
Automated Analyzer
MACHINE-BASED
SEROLOGICAL AND
Manual
IMMUNOLOGICAL TESTING
- Spectrophotometer or its equivalent
Microbiology
- Microscope (Binocular Compound)
- Staining Rack
- Bunsen Burner or Electric Loop Incinerator
- Isolation Hood with Exhaust Fan
TB DIRECT SPUTUM SMEAR
MICROSCOPY for - Timer
government facilities - Slides
- Cover Slips
- Inoculating Loops
- Applicator Sticks
- Forceps
NUCLEIC ACID - NAAT for TB
AMPLIFICATION TEST
(NAAT) for government
facilities
Additional Services for Secondary Category
KOH - Centrifuge
GRAM STAIN - Refrigerator
Additional Services for Tertiary Category
- Biosafety Cabinet (Class II Type A with certification)
- Incubator
- Drying Oven
- Autoclave
- Weighing Scale
- Water Bath
- Table Lamp
- Electric / Gas Stove
- Refrigerator with Freezer

CULTURE AND SENSITIVITY - Sterile Swabs

(aerobic and anaerobic) - Candle Jar
- Caliper / Ruler
- Graduated Cylinder
- Beaker
- Erlenmeyer Flask
- Petri Dish
- Glass Pipettes
- Calibrated Inoculating Loops
- Laboratory Thermometer

Automated System / Blood Automated Card System

Anatomic Pathology
For Secondary Category
PAP SMEAR - Microscope (Binocular Compound)

- Timer
- Slides
- Cover Slips
- Adhesive or its equivalent
- Forceps
- Staining Glasses
Additional Services for Tertiary Category
SURGICAL PATHOLOGY - Paraffin Oven
- Microtome

Manual Technique
CYTOLOGY
- Water Batj

Automated Tissue Processor

FROZEN SECTION - Cryostat
if applicable - Block Holder
AUTOPSY if applicable - Ruler
- Autopsy Table
- Bone Saw
- Scalpel
- Scissors
- Rib Shears
- Toothed Forceps
- Weighing Scale
Molecular Pathology
- Clinical Centrifuge
- Refrigerator

- PCR
- Other Machines / Equipment / Supplies

FLOOR AREA REQUIREMENT

 A. Primary Category
 Minimum 10 sqm floor area
B. Secondary Category
 Minimum 20 sqm floor area
C. Tertiary Category
 Minimum 60 sqm floor area

GENERAL CONSIDERATIONS
I. Spaces Required
The spaces/areas of the clinical laboratory shall be zoned into the following areas:
A. General Administrative Services and Public Areas
 Business Area
- Reception Area (for information and business transactions, receiving of
specimen and releasing of results)
- Waiting Area
 Collection Area
- Collection area for specimen; outside clinical working area
 Toilet Facilities
- Shall not be within clinical working area
- Accessible to public
- Separate toilet for staff
B. Clinical Working Area
C. Support Service Area
 Storage
- for records
- for supplies
 Sterilization Area / Room
 Waste Holding Area
 Staff Pantry
 Other Staff Spaces (optional)
- Offices
- Conference Room
- Locker
- Changing Room

SPECIFIC TECHNICAL REQUIREMENTS

A. Collection Area for blood extraction
- proper furniture and equipment
- work counter/tray
- space for patient seating
- hand washing stations
B. Specimen Collection Toilet for Urine and Feces
- Water closet and/or urinal and lavatory
- May be located outside the main clinical laboratory
C. Pathologist’s Area
- Located adjacent to or within the clinical working area
- Easy access to clinical working area of the laboratory
- Can be a separate room or a cubicle within the clinical working area
D. Entrance to Clinical Working Area
- Must not be directly located to high traffic areas that might cause unwanted air
current drafts
- Hand washing area (with designated dressing area) at the entry and exit points of
clinical working area
E. Sections of the Laboratory
- Each section shall be provided with stainless steel sink (depth of at least 8” and
gooseneck faucet)
- Shall be properly identified
- Separate rooms for both Histopathology and Microbiology
 - Separate room for Molecular Pathology, if provided
F. Toilets and Staff Amenities (lockers, lounge, pantry, and changing room) shall be outside
clinical working area
G. Biosafety Cabinet
-