R.A. NO. 4688

• Clinical Laboratory Act


  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
• Approved

  June 18, 1966
• Signed by

  President Ferdinand E. Marcos, Sr.
• Purpose of the Act

  • To protect
  • To promote
  • Ensures the availability of clinical laboratories that are properly managed with adequate resources, with effective and efficient performance through the compliance with quality standards
• Abbreviations

  • DOH-LTO: Department of Health – License to Operate
  • DOH-PTC: Department of Health – Permit to Construct
  • HFSRB: Health Facilities and Services and Regulatory Bureau
  • CHD-RLD: Center for Health Development-Regulation. Licensing and Enforcement Division
  • OLRS: Online Licensing and Regulatory System
  • OSSOLS: One-Stop Shop Online Licensing System
• Clinical Laboratory


  A facility that is involved in the pre-analytical, analytical, and post-analytical procedures, where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis and treatment of diseases
• Disciplines of Clinical Laboratories

  • Anatomic pathology
  • Clinical Chemistry
  • Clinical microscopy
  • Endocrinology
  • Hematology
  • Immunology and Serology
  • Microbiology
  • Molecular and Nuclear Diagnostics
• Applicant


  Any natural juridical person, government instrumentalities/agencies, partnership, corporation or agency seeking a license to operate and maintain a clinical laboratory
• Assessment Tool


  The checklist which prescribes the minimum standards and requirements for licensure of clinical laboratory
• Department of Health - License to Operate (DOH-LTO)


  A formal authorization issued by the DOH to an individual, partnership, corporation, association or any government agency/unit seeking to perform laboratory tests in compliance with the requirements prescribed in this order
• Department of Health - Permit to Construct (DOH-PTC)


  A permit issued by DOH through HFSRB or Center for Health Development-Regulation, Licensing and Enforcement Division (CHD-RLED) to an applicant who will establish and operate a hospital or other health facility, upon compliance with required documents prior to the actual construction of the said facility
• External Quality Assessment Program (EQAP)


  A program where participating CL are given unknown samples for analysis. The quality of performance of the CL shall be assessed through the closeness of its results to the pre-determined value or reference value generated by the participating CL through peer group analysis
• Initial Application


  Applications by newly constructed health facilities, or those with changes in the circumstances of the facility, such as, but not limited to, change of ownership, transfer of site, increase in beds or for additional services beyond their service capability and major alterations or renovations
• Mobile Clinical Laboratory (MCL)


  A laboratory testing unit capable of performing limited CL diagnostic procedures. It moves from one testing site to another, and it has a DOH-licensed CL as its main laboratory
• National External Quality Assessment Scheme (NEQAS)


  An EQAP activity conducted by the National Reference Laboratories to assess the quality of performance and accuracy of the results of laboratories
• National Reference Laboratory (NRL)


  The highest level of laboratory in the country performing highly complex procedures, including confirmatory testing. It is the responsible entity for facilitating NEQAS to ensure compliance to quality standards for regulation and licensing of all laboratories in the Philippines
• National Reference Laboratories

  • Research Institute for Tropical Medicine - 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; NRL for confirmatory testing of blood donors and blood units
  • San Lazaro Hospital (SACCL) - NRL for HIV/AIDS, Hepatitis and Sexually Transmitted Diseases
  • East Avenue Medical Center - NRL for Environmental and Occupational Health; Toxicology and Micronutrient Assay
  • National Kidney and Transplant Institute - NRL for Hematology including Immunohematology and Immunopathology and Anatomic Pathology
  • Philippine Heart Center - NRL Anatomic Pathology of Cardiac Diseases
  • Lung Center of the Philippines - NRL for Clinical Chemistry
• Physician's Office Laboratory (POL)


  Refers to a doctor's office/clinic wherein CL examinations are performed for the purpose of monitoring the doctor's patients only, wherein no official results shall be issued. In this Order, POL within the premises of a DOH- regulated facility shall be under the supervision of the CL
• Point of Care Testing (POCT)


  Refers to diagnostic testing done at or near the site of patient care rather than in the CL. It may be in the emergency room, operating suites, wards, and ambulances
• Satellite Clinical Laboratory (SCL)


  Refers to an extension of the main CL located within the facility's compound or premises. It shall have the same service capability as the main laboratory
• Referral Tests


  Refers to CL tests that are either sent- out or outsourced to other DOH-licensed CL with the same or higher service capability
• Classification of Ownership

  • GOVERNMENT - operated and maintained, partially or wholly, by the national government, a local government unit (provincial, city or municipal), any other political unit or any department, division, board or agency
  • PRIVATE - privately owned, established, and operated with funds through donation, principal, investment or other means, by any individual, corporation, association or organization
• Classification by Institutional Character

  • INSTITUTION-BASED a laboratory located within the premises and operates as part of a DOH licensed health facility
  • NON-INSTITUTION BASED a laboratory that operates independently and is not attached to any DOH licensed health facility
• Classification by Function

  • CLINICAL PATHOLOGY deals with the chemical and cellular analyses of blood and other body fluids (includes, but not limited to, clinical chemistry, clinical microscopy, toxicology, therapeutic drug monitoring, immunology and serology, hematology and coagulation), identification and examination of microbes and parasites (bacteriology/parasitology/mycology/ virology)
  • ANATOMIC PATHOLOGY provides processing and examination of surgical specimens as to physical appearance and microscopic structures of tissues such as, but not limited to, surgical pathology, cytopathology, immunohistochemistry techniques, autopsies and forensic pathologies
  • MOLECULAR PATHOLOGY deals with the analysis of certain genes, proteins and other molecules in samples from organs, tissues of bodily fluids in order to diagnose
  • CLINICAL LABORATORY FOR ANATOMC PATHOLOGY ONLY provides services for any of the following, but not limited to cytology and histopathology
  • CLINCAL LABORATORY FOR MOLECULAR PATHOLOGY ONLY provides services for genetics, immuno/ hematopathology and infectious disease. COVID-19 testing laboratories shall be covered by another Order
• DOH Permit to Construct (DOH-PTC)

  1. Completely filled out application form for (downloadable at www.hfsrb.doh.gov.ph), whether manual or online, shall be submitted to the DOH regulatory offices

  2. For construction of new CL and for renovation or expansion of existing CL, including change in ownership and transfer of location
• Certificate of Registration (COR)


  Required for research and teaching laboratories
• License to Operate (LTO)

  1. Applicant should submit an accomplished application form to HFSRB/CHD-RLED in accordance with the current DOH guidelines, whether manual or through the Online Licensing and Regulatory System (OLRS)

  2. The DOH-LTO is non-transferable and a new application for DOH-LTO shall be required in case of change of ownership or transfer of location

  3. Different branch(es) of a CL, even if owned by the same entity shall secure separate DOH-LTO

  4. The DOH-LTO shall be placed in an area that can be readily seen by the public, at all times

  5. For institution-based CL, the One-Stop Shop (OSS) Licensing System should be followed
• Validity

  • The DOH-LTO is valid for one (1) year
  • COR for CL that is operated and maintained exclusively for research and teaching purposes shall be required to register with the DOH-HFSRB every three (3) years
• Fees

  All fees shall follow the prescribed fees by the DOH. All fees/checks shall be paid to the order of DOH Central Office/ CHD Cashier, whichever is applicable in person, through postal money order or online payments approved by the DOH
• Monitoring

  1. Authorized representatives from the HFSRB/CHD- RLED in accordance with the current DOH guidelines, may conduct unannounced on-site visits of licensed CL and registered research and teaching laboratories to monitor and document the continuous compliance of the CL to the set standards

  2. CL that are operated and maintained exclusively for research and teaching purposes shall not issue official results for diagnostic purposes
• Roles and Responsibilities

  • HEALTH FACILITIES AND SERVICES AND REGULATORY BUREAU (HFSRB)
  • Set standards for the regulation of CL and strictly enforce the provisions of this Order
  • Disseminate regulatory policies, standards and forms for information and guidelines of the DOH- CHDs
  • Provide consultation and technical assistance to stakeholders, including regulatory officers from the DOH-CHDs in line with the regulation of CL
  • Respond promptly to complaints relative to the operation of CL under its jurisdiction
  • CENTER FOR HEALTH DEVELOPMENT – REGULATORY, LICENSING, AND ENFORCEMENT DIVISION (CHD-RLED)
  • Strictly enforce the provisions of this Order
  • Submit quarterly report on Suspension/Revocation/ Cease and Desist Order issued on CL not later than the 15th day of the following month after the covered quarter
  • Provide consultation and technical assistance to stakeholders in line with the regulation of CL
  • Respond promptly to complaints relative to the operation of CL under its jurisdiction
  • NATIONAL REFERENCE LABORATORIES (NRL)
  • Provide laboratory reference/referral services for confirmatory testing
  • Train laboratory personnel and recognize other training institutions
  • Maintain the National External Quality Assessment Scheme (NEQAS)
  • Perform technical evaluation of reagents and diagnostic kits
  • DOH-LICENSED CLINICAL LABORATORIES
  • Continuously comply with the rules and regulations, licensing standards and requirements for CL, as provided in this Order and related issuances
  • Participate in EQAP that may be administered by a designated NRL or other local and international EQAP approved by the DOH, surveys and other activities that will be required from them by the DOH
  • In times of Pandemic of Public Health Event, be mandated to submit timely reports and data
• Violations, Sanctions, and Appeal

  • A CL shall be sanctioned and penalized by the HFSRB/CHD Director upon violation of any of these guidelines and its related issuances and laws, or upon committal (commission/omission) of prohibited acts by the persons owning or operating the CL, and/or the persons under their authority
  • For non-institution-based CL that are not under the OSSOLS, the following are the penalties and sanctions that shall be imposed for the commission of any of the violations in this Order and other relevant issuances:
  • 1st offense: Stern warning
  • 2nd offense: Thirty thousand pesos (Php 30,000.00)
  • 3rd offense: Fifty thousand pesos (Php 50,000.00)
  • 4th offense: Revocation of DOH-LTO
  • Any person who operates a CL without securing the necessary DOH-PTC and corresponding DOH-LTO shall be issued a Cease-and-Desist Order (CDO) and shall pay the administrative penalty of Fifty
• EQAP approved by the DOH, surveys and other activities that will be required from them by the DOH


  • In times of Pandemic of Public Health Event, be mandated to submit timely reports and data
• Penalties and sanctions for non-institution-based CL not under the OSSOLS

  1. 1st offense: Stern warning

  2. 2nd offense: Thirty thousand pesos (Php 30,000.00)

  3. 3rd offense: Fifty thousand pesos (Php 50,000.00)

  4. 4th offense: Revocation of DOH-LTO
• Penalty for operating a CL without DOH-PTC and DOH-LTO

  Cease-and-Desist Order (CDO) and Fifty thousand pesos (Php50,000.00) administrative penalty
• Handling of complaints against CL

  CL given due process, investigation conducted, appropriate sanctions, 60-day preventive suspension possible
• Appeal process

  Appeal to Head of Health Regulation Team (HRT), final appeal to Secretary of Health
• CL with revoked licenses can only re-apply after one year from the date of LTO revocation
• Any person authorized or licensed to conduct clinical laboratory tests, who issue false or fraudulent laboratory test results knowingly, willfully or through gross negligence shall not be allowed to own, manage, operate, or be an analyst of any DOH-licensed CL
• Physical Plant


  Conformity to regulations, adequate space, well-ventilated, lighted, clean, safe and functional, proper maintenance and monitoring, laboratory biosafety and biosecurity policy, area for confirmatory testing