Clinical Laboratory

• What is the primary function of a clinical laboratory?

  To collect, process, examine, or analyze specimens from the human body for prevention, diagnosis, and treatment.
• What is Republic Act 4688?

  It is the Clinical Laboratory Law approved on June 18, 1966.
• What does Administrative Order No. 2021-0037 pertain to?

  It governs the regulation of clinical laboratories in the Philippines.
• What are the two main classifications of laboratories by ownership?

  Government and private laboratories.
• What is included in Clinical Pathology?

  Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology, Clinical Microscopy, Endocrinology, Molecular Biology, Cytogenetics, Toxicology, and Therapeutic Drug Monitoring.
• What does Anatomic Pathology encompass?

  Surgical Pathology, Immunohistopathology, Cytology, Autopsy, Forensic Pathology, and Molecular Pathology.
• What is the focus of Molecular Pathology?

  It deals with the analysis of genes, proteins, and other molecules in samples to diagnose and guide treatment of diseases.
• What is an Institution-Based laboratory?

  A laboratory that operates within the premises of an institution, such as a hospital or medical clinic.
• What is a Free-Standing laboratory?

  A laboratory that does not form part of any other institution.
• What are the classifications of laboratories by institutional character?

  • General Clinical Laboratory: Primary, Secondary, Tertiary, Limited Service Capability (institution based)
  • Special Clinical Laboratory
• What are the service capabilities of a Primary Laboratory?

  • Clinical Microscopy
  • Urinalysis
  • Fecalysis
  • Fecal Occult Blood Test
  • Pregnancy Test (Rapid Test Kits)
  • Clinical Chemistry
  • Hematology
  • Serology/Immunology
  • Microbiology
• What additional services does a Secondary Laboratory provide compared to a Primary Laboratory?

  • Serum Electrolytes
  • ALT
  • AST
  • Coagulation Studies
  • Gram Stain
  • KOH
  • Anatomic Pathology (Pap Smear)
• What services does a Tertiary Laboratory offer beyond those of a Secondary Laboratory?

  • Other Clinical Chemistry Examinations
  • Arterial Blood gases
  • Machine-based serological and immunological testing
  • Culture and sensitivity testing
  • Cytology and Histopathology
• What is the role of a National Reference Laboratory?

  To conduct confirmatory testing, surveillance, resolution of conflicting results, training, research, and evaluation of diagnostic kits.
• What is a Satellite Testing Site?

  A testing site owned by a licensed laboratory but located some distance from the main laboratory.
• What defines a Mobile Clinical Laboratory?


  A laboratory testing unit that moves from one testing site to another and has a temporary testing location.
• What are the allowed on-site tests for Mobile Clinical Laboratories?

  • Urinalysis
  • Fecalysis
  • Pregnancy Test (lateral flow)
  • Basic Serologic Tests using Rapid Test Kits
• Who is the head of a laboratory?

  The Pathologist
• What is required for the staff in a clinical laboratory?

  They must have documented training and experience to conduct laboratory procedures.
• What are the physical facility requirements for a clinical laboratory?

  • Well-ventilated
  • Adequately lighted
  • Clean and safe
  • Minimum Technical Working Area:
  • Primary - 10 sq m
  • Secondary - 20 sq m
  • Tertiary - 60 sq m
• What are the sections of a laboratory?

  • Specimen Processing
  • Hematology Section
  • Coagulation Section
  • Clinical Microscopy
  • Parasitology
  • Clinical Chemistry
  • Clinical Microbiology
  • Immunology/Serology Section
  • Immunohematology/Blood Bank
  • Histopathology/Cytopathology
• What are some common serology tests performed in a laboratory?

  • Pregnancy tests (detects B-HCG)
  • Dengue Test
  • HbsAg for hepatitis
  • Bacterial Agglutination tests (Widal test, Weil-Felix)
• What is the core function of a Laboratory Information Management System (LIMS)?

  • Sample management
  • Initiated when a sample is received
  • Registration and accessioning (barcoding)
  • Tracks chain of custody and sample location
• What are additional functions of LIMS?

  • Audit management
  • Barcode handling
  • Compliance
  • Customer relationship management
  • Document management
  • Quality assurance and control
• What is the purpose of audit logging in LIMS?


  To log all changes to LIMS data.
• What is the significance of maintaining a chain of custody in LIMS?

  It ensures the integrity and traceability of samples throughout the testing process.
• Why is personnel and workload management important in a laboratory?

  To ensure adequate staffing and efficient operation based on workload and services provided.
• What is the role of quality assurance in a laboratory?

  To ensure that laboratory processes and results meet established standards.
• What is the importance of timely reporting in laboratory diagnostics?

  It provides accurate and timely information for patient care and public health planning.
• What is the government classification of ownership?

  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 thereof
• What is the private classification of ownership?

  owned, established, and operated by any individual, corporation, association, or organization
• The National Reference Laboratory is assigned by the DOH to provide the following services?

  1. Confirmatory testing
  2. Surveillance
  3. Resolution of conflicting results
  4. Training and research
  5. Evaluation of diagnostic kits and reagents
  6. Maintain the National External Quality Assessment Scheme (NEQAS)
• Research Institute for Tropical Medicine (RITM)

  Microbiological tests such as parasitology, bacteriology, virology

  NRL for confirmatory testing of blood donors and blood units
• San Lazaro Hospital STD-AIDS Cooperative Central Laboratory (SLH-SACCL)

  NRL for sexually-transmitted diseases
• East Avenue Medical Center (EAMC)

  NRL for environmental and occupational health, toxicology, micronutrient assay - drugs of abuse
• National Kidney Transplant Institution (NKTI)

  NRL for hematology, coagulation, and immunohematology
• Lung Center of the Philippines (LCP)


  NRL for clinical chemistry
• Who are the support staff in the clinical laboratory?

  Laboratory technicians, laboratory aide, encoders, receptionists
• Quality Control Program


  Internal Quality Control

  External Quality Control
• External Quality Control

  All laboratory shall participate in an EQAS given by designated NRL

  Satisfactory performance rating - criteria for renewal of license

  Refusal to participate in EQAS-NRL - basis for suspension/revocation of license