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)

Health Facility Establishment Review Committee Checklist for Review of Floor Plans Laboratory