Guide and Requirements to Set-up a Medical or Clinical Laboratory in the Philippines: Free Standing or Hospital Based

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:

Application for Permit to Construct a Clinical Laboratory

Licensing Fees:

Licensing fees to acquire a license

Where to File:

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

PRIMARY CATEGORY
  - 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)

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

  - 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:

• 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 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.)

Job Opportunities for Medical Laboratory Professionals

Are you planning to pursue a career in medical laboratory profession and worried about your employment after graduation? Or just passed the licensure examination and you have no idea where to start your job search? 

There are a vast number of areas in which one may find employment in a medical laboratory. There are also a considerable number of names or occupational specialties by which the laboratory professional may be classified, depending on where one works and the job position occupied. In addition, the various agencies and state licensing bodies will confer varying titles on the medical laboratory worker. While the majority of clinical laboratory workers are employed by hospital laboratories, there are numerous other opportunities for interesting and rewarding employment, ranging from the most common employment as a professional in the hospital setting to positions in the business sector as well as in educational institutions, and even in research or in legal categories of work such as in a state crime laboratory. Among these general categories of employment, there are numerous specialties within these overall areas.

Specific examples of some of these job opportunities are in government research laboratories or pharmaceutical companies that use medical laboratorians to produce data and compile research information for new medications and their effects on patients. Commercial reference laboratories are commonly used by hospital laboratories for seldom-requested tests and for special procedures that are not economically feasible due to the time, equipment, or supplies needed for the testing or that are beyond the abilities of the routine laboratories. To a lesser extent, POLs (which often provide for more flexible scheduling than hospital laboratories), state or federal crime laboratories, and the education setting are other avenues to pursue for meaningful employment. Laboratory professionals on all levels are gaining lucrative employment in sales for equipment and expendable supplies, product development, training of workers to use new equipment, and technical service departments of major manufacturers. An increasing need for medical laboratory workers of all specialties and designations has spurred the enrollment of greater numbers of students pursuing a laboratory vocation in the past few years and is continuing.

The Clinical Laboratory Law: RA 4688

Managing clinical laboratories in the Philippines is legally guided by Republic Act 4688 or the Clinical Laboratory Law of 1966 with several Administrative Orders (AO) and Executive Orders (EO) to supplement its implementation.

The legal history of RA 4688 started on June 18, 1966 when it was approved and ratified by the president of the Philippines. The law then developed with the aid of several Administrative and Executive Orders that were issued for supplementation and regulatory guidelines in support of RA 4688.

The following Administrative and Executive Orders were issued in relation to RA 4688:

• AO 201 s. 1973
• AO 290 s. 1976
• AO 52 s. 1983
• AO 49-B s. 1988
• EO 102 s. 1999 (Redirecting the Functions and Operations of the DOH)
• AO 59 s. 2001 (Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines)
• AO 27 s. 2007 (Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines)

REPUBLIC ACT NO. 4688

REPUBLIC ACT NO. 4688 - AN ACT REGULATING THE OPERATION AND MAINTENANCE OF CLINICAL LABORATORIES AND REQUIRING THE REGISTRATION OF THE SAME WITH THE DEPARTMENT OF HEALTH, PROVIDING PENALTY FOR THE VIOLATION THEREOF, AND FOR OTHER PURPOSES 

Section 1. Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions and radioactivity from beings or animals are analyzed for the determination of the presence of pathologic organisms, processes and/or conditions in the persons or animals from which they were obtained, shall register and secure a license annually at the office of the Secretary of Health: provided, that government hospital laboratories doing routine or minimum laboratory examinations shall be exempt from the provisions of this section if their services are extensions of government regional or central laboratories.

Sec. 2. It shall be unlawful for any person to be professionally in-charge of a registered clinical laboratory unless he is a licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health, such authorization to be renewed annually. 

No license shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory unless such laboratory is under the administration, direction and supervision of an authorized physician, as provided for in the preceding paragraph. 

Sec. 3. The Secretary of Health, through the Bureau of Research and Laboratories shall be charged with the responsibility of strictly enforcing the provisions of this Act and shall be authorized to issue such rules and regulations as may be necessary to carry out its provisions. 

Sec. 4. Any person, firm or corporation who violates any provisions of this Act or the rules and regulations issued thereunder by the Secretary of Health shall be punished with imprisonment for not less than one month but not more than one year, or by a fine of not less than one thousand pesos nor more than five thousand pesos, or both such fine and imprisonment, at the discretion of the court. 

Sec. 5. If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof. 

Sec. 6. The sum of fifty thousand pesos, or so mush thereof as may be necessary, is hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effect the provisions of this Act. 

Sec. 7. All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed. 

Sec. 8. This Act shall take effect upon its approval. 

Approved: June 18, 1966

Medical Technologists and Their Role in Healthcare

Medical technologist (also referred to as a medical laboratory scientist, a clinical laboratory scientist, or clinical laboratory technologist) is a healthcare professional who performs hematological, chemical, immunologic, microscopic, and bacteriological diagnostic analyses on body fluids such as blood, urine, sputum, stool, cerebrospinal fluid (CSF), various body fluids as well as other specimens. Medical laboratory scientists work in clinical laboratories at hospitals, doctor's offices, reference labs, biotechnology labs and production-based industrial labs.

The Medical Laboratory: It’s Staff and Management

A medical laboratory is a laboratory where tests are done on human clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.

Medical laboratories may be classified as free-standing laboratory or hospital-based laboratory based on its facilities, target clientele, and hospital affiliation.

Laboratory medicine is generally divided into two fields, and each of which is further divided into a number of sections. These two broad fields are:

Anatomic Pathology: units included here are histopathology, cytopathology, and electron microscopy. Academically, each unit is studied alone in one course. Other courses pertaining to this section include anatomy, physiology, histology, pathology, and pathophysiology.

Clinical Pathology which includes:

Clinical Microbiology: This encompasses five different sciences (units or sections). These include bacteriology, virology, parasitology, immunology, and mycology.

DOT and IATA Specimen Transport Regulations

Under U.S. Department of Transportation (DOT) and International Air Transport Association (IATA) regulations, all diagnostic specimens require triple packaging. This includes the following:

The Standard Precautions in the Laboratory

Standard precautions is the combination of the major features of the Universal Precautions(UP) and Body Substance Isolation(BSI).It should be used for the care of patients and also for the protection of the healthcare workers. Standard precautions include the following:

Medical Technologists Code of Ethics of the Philippines

As I enter the practice of medical technology, I shall:

• Accept the responsibilities inherent to being a professional. 
• Uphold the law and shall not engage in illegal work nor cooperate with anyone engaged. 
• Avoid associating or being identified with any enterprise of questionable character 
• Work and act in a strict spirit of fairness to employer, clients, contractors, employees and in a spirit of personal helpfulness and fraternity toward other members of the profession.