Application for Permit to Construct a Clinical Laboratory

What this is For:

[u]Application for Permit to Construct a Clinical Laboratory[/u]
Where to File:
BUREAU OF HEALTH FACILITIES AND SERVICES
Bldg. 15, San Lazaro Compound, Rizal Avenue, Sta. Cruz, Manila
How to File:
Submit application to the Bureau of Health Facilities and Services. A copy of Permit to construct and
Approved Floor Layouts shall be issued within 15 working days upon receipt of application provided that
all documents are complete and compliant.
NOTE:
LICENSING REQUIREMENTS OF A CLINICAL LABORATORY SERVICE CAPABILITY
PRIMARY CATEGORY
Routine Fecalysis
Routine Hematology
(Complete Blood Count or CBC) includes Hemoglobin Mass Concentration, Erythrocyte Volume Fraction
(Hematocrit), Leucocytes Number Concentration (White Blood Cell or WBC Count), Leucocytes Type
Number Fraction (Differential Count) and Qualitative Platelet Determination
Routine Urinalysis
Blood Typing hospital based
Quantitative platelet determination hospital based
SECONDARY CATEGORY
ALL those in Primary Category PLUS the
following:
Routine Clinical Chemistry includes Blood Glucose Substance Concentration, Blood Urea Nitrogen
Concentration, Blood Uric Acid Substance Concentration, Blood Creatinine Concentration and Blood
Total Cholesterol Concentration
Cross matching hospital based
TERTIARY CATEGORY
ALL those in Secondary Category PLUS the
following:
Immunology/Serology
Microbiology
Special Chemistry
Special Hematology
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.
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 CATEGORY
Clinical centrifuge
Differential blood cell counter or its equivalent
Hemacytometer
Hemoglobinometer or its equivalent
Microhematocrit centrifuge
Microscope w/ oil immersion objective
SECONDARY CATEGORY
ALL those in Primary Category PLUS the following:
Photometer or its equivalent
Refrigerator
Timer or its equivalent
Water bath or its equivalent
TERTIARY CATEGORY
ALL those in Secondary Category PLUS the following:
Autoclave
Balance, trip/analytical
Biosafety cabinet or its equivalent
Drying oven
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 CATEGORY
Minimum of 10 square meters in floor area
Access to Toilet
Clinical Work Area with Sink
Pathologist Area
SECONDARY CATEGORY
Minimum of 20 square meters in floor area
Toilet
Clinical Work Area with Sink
Pathologist Area
TERTIARY CATEGORY
Minimum of 60 square meters in floor area
Toilet
Clinical Work Area with Sink
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.
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

Other Documentary Requirements:
Form No. 4-01: Application for Permit to Construct notarized
Letter of Application to the Director of the Bureau of Health Facilities and Services
Letter of Endorsement from the Director of the Center for Health Development
Four (4) Sets of Floor Layout, showing location of equipment and areas required,
appropriately dimensioned, properly identified and completely labeled
DTI/SEC Registration (for private clinical laboratory)