M4.2

• REPUBLIC ACT NO. 4688

  LICENSING OF CLINICAL LABORATORIES.

  • Republic Act No. 4688, enacted in 1966, mandated the DOH to regulate the operation, maintenance and registration of clinical laboratories.
  • DOH issued Administrative Order No. 2007-0027, updating the minimum standards and technical requirements for clinical laboratories to ensure the accuracy and precision of laboratory examinations to safeguard public health and safety.
• REPUBLIC ACT NO. 4688

  ADMINISTRATIVE ORDER NO. 2007-0027 PROVIDED FOR

  THE CLASSIFICATION OF CLINICAL LABORATORIES:

  • According to Ownership (government or private)
  • Function (clinical pathology or anatomical pathology)
  • Institutional character (institution - based or free – standing ) and
  • Service capability for general clinical laboratories (primary, secondary and tertiary categories) and special clinical laboratory.
• REPUBLIC ACT NO. 4688

  ADMINISTRATIVE ORDER NO. 2007-0027 PROVIDED FOR

  THE CLASSIFICATION OF CLINICAL LABORATORIES:

  • 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 require that every clinical laboratory be managed by a Philippine Board of Pathology
  • And that supervision of laboratory staff such as medical technologists and other health professionals shall follow the standards set by the Philippine Society of Pathologists.
• REPUBLIC ACT NO. 4688

  ADMINISTRATIVE ORDER NO. 2007-0027 PROVIDED FOR

  THE CLASSIFICATION OF CLINICAL LABORATORIES:

  • Administrative Order No. 2007-0027 also sets the standards for physical facilities, equipment and supplies, administrative and technical policies and procedures, and a Quality Assurance Programs (QAP).
  • Procedural guidelines for registration, licensing, inspection and monitoring, investigation of complaints, penalties for violation and manner of appeal are also stipulated.
• MEASURE OF QUALITY CONTROL, CLINICAL LABORATORIES ARE REQUIRED OF THE FF:

  Internal and External quality assurance program (QAP)

  • Internal QAP covers, inputs, processes and outputs, and the practice of continuous quality improvement covers all aspects of laboratory performance.
  • A clinical laboratory is also required to participate 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.
• LOCAL INSTITUTIONS HAVE BEEN DESIGNATED AS NATIONAL REFERENCE LABORATORIES (NRLS)

  • 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.
• LOCAL INSTITUTIONS HAVE BEEN DESIGNATED AS

  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.