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• Republic Act No. 4226


  Hospital Licensure Act of 1965, mandated the DOH Bureau of Medical Services, now called the Health Facilities and Services Regulatory Bureau (HFSRB)
• Adopt a system of classifying hospitals

  Take into account their service capacities and compliance with standards for human resources, equipment, construction and physical facilities
• Updated classification of hospitals

  • According to ownership (government or private)
  • Scope of services (general hospital or specialty hospital)
  • Functional capacity (Level 1, Level 2, Level 3)
• Specialty hospital


  A hospital that specializes in a particular disease or condition, a particular organ or groups of organs, and particular groups of patients
• Republic Act No. 4226 and Administrative Order No. 2012-0012 ensure the quality of services rendered by hospitals and assure the safety of patients and hospital personnel
• Standards for hospitals


  • Human resources
  • Physical infrastructure
  • Equipment and instruments
  • Service delivery
  • Quality improvement activities
  • Information management
  • Environmental management
• Simplify the licensing systems and processes, and make the regulatory scheme more effective and efficient

  1. Application processes for certificate of need (CON).

  2. Permit to construct and LTO, including their renewal and validity

  3. Procedures for inspection and monitoring of hospitals, investigation of charges and complaints, penalties for violations and manner of appeal
• Republic Act No. 4688 mandated the DOH to regulate the operation, maintenance and registration of clinical laboratories
• Administrative Order No. 2007-0027 updated the minimum standards and technical requirements for clinical laboratories to ensure the accuracy and precision of laboratory examinations to safeguard public health and safety
• Classification of clinical laboratories

  • According to Ownership (government or private)
  • Function (clinical pathology or anatomical pathology)
  • Institutional character (institution-based or free-standing)
  • Service capability for general clinical laboratories (primary, secondary and tertiary categories) and special clinical laboratory
• Clinical laboratories that exclusively operate for research and teaching purposes are exempted from the licensing requirements, provided that they register with the HFSRB
• Standards for HRH


  Every clinical laboratory be managed by a Philippine Board of Pathology, and supervision of laboratory staff such as medical technologists and other health professionals shall follow the standards set by the Philippine Society of Pathologists
• Standards for clinical laboratories

  • Physical facilities
  • Equipment and supplies
  • Administrative and technical policies and procedures
  • Quality Assurance Programs (QAP)
• Procedural guidelines for clinical laboratories

  Registration, licensing, inspection and monitoring, investigation of complaints, penalties for violation and manner of appeal
• Measures of quality control for clinical laboratories

  • Internal and External quality assurance program (QAP)
  • Participation in the National External Quality Assessment Scheme administered by designated National Reference Laboratories (NRLs) or in other local or international external GAPs recognized by the DOH
• Designated National Reference Laboratories (NRLs)

  • Research Institute for Tropical Medicine for dengue, TB, influenza, malaria
  • San Lazaro Hospital for HIV/AIDS, sexually transmitted infections and hepatitis
  • East Avenue Medical Center for environmental and occupational health and toxicology
  • National Kidney and Transplant Institute for hematology, immunopathology and anatomical pathology for renal diseases
  • Philippine Heart Center for anatomical pathology for cardiac diseases
  • Lung Center of the Philippines for biochemistry and anatomical pathology for pulmonary diseases
• Other types of health facilities are similarly covered by the rules and regulations for licensing and registration required by the DOH, including primary care facilities
• Other types of health facilities are similarly covered by the rules and regulations for licensing and registration required by the DOH
• Included health facilities

  • Primary care facilities
  • Infirmaries
  • Birthing homes
• Primary care facilities


  • First-contact health facilities that offer basic services, including emergency services and provision for normal deliveries
  • Have inpatient beds
• Custodial care facilities


  • Psychiatric care facilities
  • Substance abuse treatment and rehabilitation centers
  • Sanitaria
  • Nursing homes
• Custodial care facilities providing long-term care are required to acquire licenses
• Specialized outpatient facilities


  • Dialysis clinics
  • Ambulatory surgical clinics
  • In vitro fertilization centers
  • Stem cell facilities
  • Oncology clinics
  • Medical facilities for overseas workers and seafarers
  • Physical medicine and rehabilitation centers
• Specific regulatory standards and licensing procedures are also applied to specialized outpatient facilities
• License validity


  Licenses of hospitals, laboratories, infirmaries, and specialized outpatient facilities are valid for a period of 1 year
• The license may be suspended or revoked at any time for violation of specific rules, regulations and standards set by the DOH