A medical laboratory or clinical laboratory is a laboratory where tests are usually done on clinical specimens in order to obtain information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease. Clinical laboratories are thus focused on applied science mainly on a production-like basis, as opposed to research laboratories that focus on basic science on an academic basis.
If you're planning to set-up a clinical laboratory in the Philippines, either a Free Standing or Hospital Based, below is a step by step guide and requirements including equipment, personnel and floor plan needed for acquiring a license.
Form to be used:
Licensing Fees:
Where to File:
BUREAU OF HEALTH FACILITIES AND SERVICES (BHFS)
Address: Bldg. 15, San Lazaro Compound, Rizal Avenue, Sta. Cruz, Manila
BUREAU OF HEALTH FACILITIES AND SERVICES (BHFS)
Address: Bldg. 15, San Lazaro Compound, Rizal Avenue, Sta. Cruz, Manila
How to File:
Submit the application form 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: Refer below for the services or tests to be offered per category
A. LICENSING REQUIREMENTS OF A CLINICAL LABORATORY SERVICE CAPABILITY
Submit the application form 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: Refer below for the services or tests to be offered per category
A. LICENSING REQUIREMENTS OF A CLINICAL LABORATORY SERVICE CAPABILITY
PRIMARY CATEGORY
- Routine Fecalysis
- Routine Fecalysis
- Routine Urinalysis
- 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
- Blood Typing (Hospital-Based)
- Quantitative platelet determination (Hospital-Based)
- 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
B. 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.
C. EQUIPMENT/INSTRUMENTS
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
- 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
- Biological Safety cabinet or its equivalent
- Drying oven
- Incubator
- Rotator
- Clinical Centrifuge or its equivalent
2. For other laboratory examinations being performed, the appropriate equipment for performing such procedures shall be made available.
D. FLOOR PLAN REQUIREMENT
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:
- 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
- Biological Safety cabinet or its equivalent
- Drying oven
- Incubator
- Rotator
- Clinical Centrifuge or its equivalent
2. For other laboratory examinations being performed, the appropriate equipment for performing such procedures shall be made available.
D. FLOOR PLAN REQUIREMENT
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
- 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 dimension, properly identified and completely labeled
- DTI/SEC Registration (for private clinical laboratory)
What we can offer:
- IF YOU'RE LOOKING FOR A SUPPLIER FOR AFFORDABLE EQUIPMENT AND INSTRUMENTS FOR YOUR LABORATORY SET-UP, PLEASE DON'T HESITATE TO CONTACT US. WE'LL BE HAPPY TO ASSIST YOU AND SEND YOU A QUOTATION/PROPOSAL. WE WILL ALSO ASSIST FOR THE DOCUMENTATIONS NEEDED TO ACQUIRE A LICENSE (e.g. S.O.P.)
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