M3

• The Clinical Laboratory Act RA 4688 was promulgated on June 18, 1966, to regulate the operation and maintenance of clinical laboratories and require their registration with the Department of Health.
• Government hospital laboratories doing routine or minimum laboratory examinations are exempt from the provisions of the Clinical Laboratory Act if their services are extensions of government regional or central laboratories.
• It is unlawful for any person to be professionally in charge of a registered clinical laboratory unless they are 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.
• The decision of the Office of the Health Secretary is final and executory.
• BHFS shall promptly certify and file a copy of the decision, including all documents and transcript of hearings on which the decision is based, with the Office of the Health Secretary for review.
• This Order takes effect 15 days after its approval & publication in the official gazette/newspaper of general circulation.
• The decision of the BHFS/CHD may be appealed to the Office of the Health Secretary within ten (10) days after receipt of the notice of the decision.
• Provisions from previous issuances that are inconsistent or contrary to the provisions of this Order are hereby rescinded and modified accordingly.
• In the event that any provision or part of this Order be declared unauthorized or rendered invalid by any court of law or competent authority, those provisions not affected by such declaration shall remain valid and effective.
• The Secretary of Health, through the Bureau of Research and Laboratories, is charged with the responsibility of strictly enforcing the provisions of the Clinical Laboratory Act and is authorized to issue such rules and regulations as may be necessary to carry out its provisions.
• Any person, firm or corporation who violates any provisions of the Clinical Laboratory 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.
• The NRL that is physically independent from the clinical laboratory of the hospital where they are respectively assigned shall be allowed to register only with the BHFS, provided that, they are duly accredited or certified by an international accrediting or certifying body, such as the Center for Disease Control of the USA and the World Health Organization and/or local accrediting or certifying body recognized by the DOH.
• The NRL designated by the DOH shall be covered by the license of the clinical laboratory of the hospital where they are respectively assigned.
• Lung Center of the Philippines is the NRL for Clinical Chemistry.
• East Avenue Medical Center is the NRL for Environmental and Occupational Health; Toxicology and Micronutrient Assay.
• A pathologist or a licensed physician who is trained in the management, principles and methodology of the specialized services that are being provided shall head this type of laboratory.
• Special Clinical Laboratories are required to register with the BHFS without being licensed.
• National Kidney and Transplant Institute is the NRL for Hematology including Immunohematology and Immunopathology and Anatomic Pathology.
• Research Institute for Tropical Medicine is the NRL for Dengue, Influenza, Tuberculosis and other Mycobacteria, Malaria and other parasites, Bacterial enteric diseases, measles and other viral exanthems, Mycology, Enteroviruses, Antimicrobial resistance and Emerging Diseases, and is also the NRL for confirmatory testing of blood donors and blood units.
• Limited Service Capability provides the laboratory tests required for a particular service in institutions such as dialysis centers and social hygiene clinics.
• Tertiary Category provides the minimum service capabilities of a secondary category laboratory plus Special Chemistry, Special Hematology, Immunology, Microbiology, and Aerobic and anaerobic.
• Special Clinical Laboratory offers highly specialized laboratory services that are usually not provided by a general clinical lab oratory.
• Philippine Heart Center is the NRL for Anatomic Pathology of Cardiac Diseases.
• San Lazaro Hospital (SACCL) is the NRL for HIV/AIDS, Hepatitis and Sexually Transmitted Diseases.
• If any section or part of the Clinical Laboratory Act is adjudged by any court of competent jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof.
• The sum of fifty thousand pesos, or so much 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 the Clinical Laboratory Act.
• All Acts or parts of Acts which are inconsistent with the provisions of the Clinical Laboratory Act are hereby repealed.
• The Clinical Laboratory Act shall take effect upon its approval.
• Hospital based clinical laboratories shall be licensed as part of the hospital through the One-Stop-Shop Licensure for Hospitals and are therefore not required to obtain a separate license.
• Mobile clinical laboratories shall be licensed as part of the main clinical laboratory and shall be permitted to collect specimens only.
• Clinical laboratory and its satellite services within the same compound shall have one (1) LTO.
• Retention of laboratory records shall be in accordance to the standards promulgated by the DOH or by competent authorities for such purposes.
• Physical facilities/work environment of clinical laboratories shall provide well-ventilated, lighted, clean, safe and functional areas based on the services provided.
• LTO issued to a non-hospital based clinical laboratory must be displayed at all times at a prominent place within the laboratory premises.
• When laboratory examinations are referred to and provided by an outside laboratory, the head of the referring clinical laboratory shall obtain assurance of the quality of services provided through a Memorandum of Agreement or its equivalent with a licensed clinical laboratory performing the laboratory services needed.
• Clinical laboratories shall have procedures for the proper disposal of waste and hazardous substances.
• LTO is issued in the name of the licensee and is non-transferable, whether voluntarily or involuntarily, through sale, assignment or any other means.
• Satellite laboratory outside the premises where the central laboratory is situated shall be required to secure a separate LTO.
• Mobile clinical laboratories shall be allowed to operate only within one hundred (100) km radius from its main laboratory.