RA 4688

• RA 4688
• RA 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
• Approved by President Ferdinand E. Marcos


  June 18, 1966
• Any person, firm or corporation, operating and maintaining a clinical laboratory

  • Shall register and secure a license annually at the office of the Secretary of Health
  • Exempted: government hospital laboratories doing routine or minimum laboratory examinations
• Head of the registered clinical laboratory

  Licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health
• Secretary of Health, through the Bureau of Research and Laboratories

  1. Enforce the provisions of this act

  2. Authorized to issue rules and regulations
• Administrative Order No. 2007-0027 - "Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines"
• Administrative Order No. 2021-0037 - "New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines"
• Classifications of Clinical Laboratories

  • By Institutional Character: Institution-based, Free standing
  • By Ownership: Government, Private
  • By Function: Clinical Pathology, Anatomic Pathology, Molecular Pathology
  • By Service Capability: General Clinical Laboratory (Primary, Secondary, Tertiary), Limited Service Capability, Special Clinical Laboratory
• Government


  Operated and maintained, partially or wholly, by the national government, a local government unit, any other political unit or any department, division, board or agency
• Private


  Owned, established and operated by any individual, corporation, association or organization
• Clinical Pathology


  Deals with the chemical and cellular analyses of blood and other body fluids
• Molecular Pathology


  Deals with the analysis of certain genes, proteins and other molecules in samples
• Anatomic Pathology


  Provides processing and examination of surgical specimens
• Institution-based


  A laboratory that is located within the premises and operates as part of a DOH licensed health facility
• Free Standing


  A laboratory that operates independently and is not attached to any DOH licensed health facility
• Classification by Service Capability

  • Primary Category
  • Secondary Category
  • Tertiary Category
  • Limited Service Capability
  • Special Clinical Laboratory
• Limited Service Capability

  For institution-based only, provides the laboratory tests required for a particular service in institutions
• Special Clinical Laboratory


  A laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory, such as: Assisted reproduction technology, Molecular and cellular technology, Molecular biology, Molecular pathology, Forensic pathology, Anatomic pathology
• Sections in AO No. 2021-0037

  • Clinical Microscopy
  • Clinical Chemistry
  • Hematology
  • Serology/Immunology
  • Microbiology
  • Anatomic Pathology
• AO No. 2020-0014 - Guidelines in Securing a License to Operate a COVID-19 Testing Laboratory in the Philippines
• Permit to Construct

  1. A DOH-PTC shall be required for construction of new clinical laboratory and for renovation or expansion of existing clinical laboratory, including change of ownership and transfer of location

  2. Requirements: Accomplished application form, Proof of ownership, Three sets of architectural floor plans, Approved CON issued by the Regional Office (for new general hospitals)
• License to Operate

  1. Any person, firm or corporation desiring to establish, operate and maintain clinical laboratory shall submit application to HFSRB/CHD-RLED

  2. Requirements: Completely filled out application Form 1 and its attachment, Notarized Acknowledgement, Proof of ownership
• A DOH-PTC shall be required for construction of new clinical laboratory and for renovation or expansion of existing clinical laboratory, including change of ownership and transfer of location
• Requirements for DOH-PTC


  • Accomplished application form for the specific facility
  • Proof of ownership
  • Three sets of architectural floor plans
  • Approved CON issued by the Regional Office (for new general hospitals)
• Any person, firm or corporation desiring to establish, operate and maintain clinical laboratory shall submit application to HFSRB/CHD-RLED
• Requirements for License to Operate (LTO)

  • Completely filled out application Form 1 and its attachment
  • Notarized Acknowledgement
  • Proof of ownership
  • Accomplished Self-Assessment Tool
  • Health Facility Geographic Form
  • Copy of official receipt payment
• Clinical laboratory and its satellite services within the same compound

  Shall have one LTO
• Satellite laboratory outside the premises where the central laboratory is situated

  Shall required to secure a separate LTO
• Mobile clinical laboratories

  Licensed as part of the main laboratory, and are allowed to operate within 100-kilometer radius from its main laboratory
• Clinical laboratories that are operated and maintained exclusively for research and teaching purposes shall be exempted from the licensing requirement but shall be required to register with the DOH-HFSRB
• DOH-LTO


  Shall be placed in an area that can be readily seen by the public at all times
• Certificate of Registration (COR)


  Required for research and teaching laboratories
• Validity of DOH-LTO

  Valid for one year
• Validity of COR for clinical laboratory

  Shall be required to register with the DOH-HFSRB every 3 years
• Renewal of hospital based clinical laboratories shall be in accordance with licensing process under the One-Stop-Shop Licensure system for hospitals
• Non-hospital based clinical laboratories shall file applications for renewal of LTO beginning on the first day of October until the last day of November of the current year
• Areas inspected and monitored by HFSRB and CHD


  • Physical Facilities
  • Staffing/Human Resource
  • Waste Management
  • Glasswares/Reagents/Supplies
  • Equipment/Instruments
  • Technical Procedures
  • Administrative Policies and Procedures
  • Referral of Examinations
  • Communication and Records
  • Quality Control Program
• Pathologist

  Must be the head and manager of every clinical laboratory, certified by the Philippine Board of Pathology (PBP)
• Requirements for pathologist

  • Mandatory for: All free-standing clinical laboratory, Tertiary category laboratories, All secondary categories in areas with sufficient available pathologist
  • Voluntary for: All primary and secondary category hospital laboratories in areas where pathologist is not sufficient