Department of Health

BUREAU OF HEALTH FACILITIES AND SERVICES

2nd Floor Bldg.4, San Lazaro Compound, Rizal Avenue, Sta. Cruz, Manila

LICENSING REQUIREMENTS OF A CLINICAL LABORATORY

SERVICE CAPABILITY

PRIMARY SECONDARY TERTIARY

CATEGORY CATEGORY CATEGORY
Routine Fecalysis ALL those in Primary ALL those in Secondary
Routine Hematology Category PLUS the Category PLUS the
(Complete Blood Count or following: following:
CBC) – includes Routine Clinical Chemistry – Immunology/Serology
Hemoglobin Mass includes Blood Glucose Microbiology
Concentration, Erythrocyte Substance Concentration, Special Chemistry
Volume Fraction Blood Urea Nitrogen Special Hematology
(Hematocrit), Leucocytes Concentration, Blood Uric
Number Concentration Acid Substance
(White Blood Cell or WBC Concentration, Blood
Count), Leucocytes Type Creatinine Concentration
Number Fraction and Blood Total
(Differential Count) and Cholesterol Concentration
Qualitative Platelet Cross matching – hospital
Determination based
Routine Urinalysis
Blood Typing – hospital
based
Quantitative platelet
determination – hospital
based

PERSONNEL

1. The Clinical Laboratory shall be managed by a licensed physician certified by the

Philippine Board of Pathology.
1.1. In areas where pathologists are not available, a physician with a three (3) months
training on clinical laboratory medicine, quality control and laboratory management,
may manage a primary/secondary category clinical laboratories. The BHFS shall
certify such training.

2. The clinical laboratory shall employ qualified and adequately trained personnel. Work
assignment shall be consistent with the qualification of the concerned personnel.
2.1. A clinical laboratory shall have sufficient number of registered medical
technologists proportional to the workload and shall available at all times during
hours of laboratory operation. For hospital-based clinical laboratory, there shall be at
least one registered medical technologist per shift to cover the laboratory operation.

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3. There shall be staff development and appropriate continuing education program available
at all levels of organization to upgrade the knowledge, attitudes and skills of staff.

EQUIPMENT/INSTRUMENT

1. There shall be sufficient number and types of appropriate equipment/instrument in order

to undertake all the laboratory examinations and procedures. The equipment/instrument
shall comply with safety requirements.

PRIMARY SECONDARY TERTIARY

CATEGORY CATEGORY CATEGORY
Clinical centrifuge ALL those in Primary ALL those in Secondary
Differential blood cell Category PLUS the Category PLUS the
counter or its equivalent following: following:
Hemacytometer Photometer or its equivalent Autoclave
Hemoglobinometer or its Refrigerator Balance, trip/analytical
equivalent Timer or its equivalent Biosafety cabinet or its
Microhematocrit centrifuge Water bath or its equivalent equivalent
Microscope w/ oil immersion Drying oven
objective Incubator
Rotator
Serofuge or its equivalent

2. For other laboratory examinations being performed, the appropriate equipment for
performing such procedures shall be made available.

PHYSICAL PLANT

1. Adequate area shall be provided for the people, activity, furniture, equipment and utility.

PRIMARY SECONDARY TERTIARY

CATEGORY CATEGORY CATEGORY
Minimum of Minimum of Minimum of
10 square meters 20 square meters 60 square meters
in floor area in floor area in floor area
Access to Toilet Toilet Toilet
Clinical Work Area with Clinical Work Area with Clinical Work Area with
Sink Sink Sink
Pathologist Area Pathologist Area Pathologist Area
Microbiology Room

2. A clinical laboratory shall be of such construction so that no hazards to the life and safety
of patients, personnel and public exist. It shall be capable of withstanding weight and
elements to which they may be subjected.

3. It shall be provided with sufficient illumination and adequate ventilation to enable

personnel in the performance of work and to ensure comfort of patients, personnel and
public.

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4. Floors, walls, ceilings, fixtures and furniture shall be of sturdy materials that shall allow
durability, ease of cleaning, fire and acid resistance.

5. There shall be measures for detecting fire such as fire alarms in walls, peepholes in doors
or smoke detectors in ceilings. There shall be devices for quenching fire such as fire
extinguishers or fire hoses that are easily visible and accessible in strategic areas.

6. Proper maintenance shall be provided to prevent untimely breakdown of building and

equipment.

7. Liquid waste shall be discharged into an approved public sewerage system, and solid
waste shall be collected, treated and disposed of in accordance with applicable codes,
laws or ordinances.

8. References shall be made to the following:

• P. D. 1096 – National Building Code of the Philippines and Its Implementing
Rules and Regulations
• P. D. 1185 – Fire Code of the Philippines and Its Implementing Rules and
Regulations
• P. D. 856 – Code on Sanitation of the Philippines and Its Implementing Rules and
Regulations
• R. A. 1378 – National Plumbing Code of the Philippines and Its Implementing
Rules and Regulations
• R. A. 184 – Philippine Electrical Code
• Manual on Technical Guidelines for Hospitals and Health Facilities Planning and
Design. Department of Health, Manila. 1994
• Health Facilities Maintenance Manual. Department of Health, Manila. 1995
• Manual on Hospital Waste Management. Department of Health, Manila. 1997

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