M8

• Clinical laboratory


  An essential component of health institutions that provides accurate and reliable information to medical doctors for the diagnosis, prognosis, treatment, and management of disease
• Majority of doctor's decisions are based on laboratory results
• Activities of the clinical laboratory

  • Research
  • Community outreach programs
  • Surveillance
  • Infection control
• What happens to specimens in the clinical laboratory

  • Collected
  • Processed
  • Analyzed
  • Preserved
  • Properly disposed
• Clinical laboratories


  • Vary according to size, function, and complexity of tests performed
• Clinical laboratory scientist


  Key role in performance of laboratory testing and ensuring reliability of results
• In the past, the assays in the clinical lab were manual, taxing, labor-intensive, time consuming
• With the advent of automation, assays are less laborious, with shortened TAT (turn-around time)
• Classification of laboratories


  • According to Function
  • According to Institutional Characteristics
  • According to Ownership
  • According to Service Capability
• Clinical pathology

  Focuses on the areas of clinical chemistry, immunohematology, and blood banking, medical microbiology, immunology and serology, hematology, parasitology, clinical microscopy, toxicology, therapeutic drug monitoring, and endocrinology
• Anatomic pathology

  Focuses on the areas of histopathology, immunohistopathology, cytology, autopsy, and forensic pathology. Concerned with the diagnosis of diseases through microscopic examination of tissues and organs
• Institution-based laboratory


  A clinical laboratory that operates within the premises or part of an institution such as a hospital, school, medical clinic, medical facility for overseas workers, etc.
• Free-standing laboratory


  A clinical laboratory that is not part of an established institution. The most common example is a free-standing outpatient clinical laboratory
• Types of ownership


  • Government-owned
  • Privately-owned
• Service capability of primary laboratory

  • Basic
  • Routine
  • Routine Urinalysis
  • Fecalysis
• Primary laboratory requirements


  • Microscopes
  • Centrifuge
  • 10 square meters space
• Routine clinical chemistry tests in primary laboratory

  • Blood Glucose
  • Cholesterol
  • Creatinine/ BUN
• Secondary laboratory requirements


  • Primary lab requirements plus Gram stain, KOH (if hospital based)
  • 20 sq.m. area
  • Chemistry Analyzers
• Additional tests in primary and secondary laboratoryfor TERTIARY LABORATORY

  • Immunology-Serology
  • Microbiology
  • Blood Banking
• Tertiary laboratory requirements


  • Secondary lab requirements plus BSC II, serofuge, chemistry analyzers, blood bank refrigerators, etc.
  • 60 sq.m. area
• Additional tests in tertiary laboratory

  • Special Chemistry
  • Special Hematology
  • Immunology/Serology
  • Microbiology
• Reference laboratory


  A laboratory in a government hospital designated by the DOH to provide specialized diagnostic functions and services for certain diseases. In charge of training medical technologists
• Examples of national reference laboratories

  • East Avenue Medical Center
  • Lung Center of the Philippines
  • Research Institute for Tropical Medicine
  • Philippine Heart Center
  • San Lazaro Hospital - STD AIDS Cooperative Central Laboratory (SACCL)
• RA 4688 requires all clinical laboratories to register and secure a license annually at the office of the Secretary of Health
• Licensed physician in charge of clinical laboratory

  Duly qualified in laboratory medicine and authorized by the Secretary of Health, such authorization to be renewed annually
• Bureau of Health Facilities and Services (BHFS)


  The DOH unit that exercises the regulatory functions under the rules and regulations for clinical laboratories
• The rules and regulations aim to protect and promote health by ensuring availability of properly managed clinical laboratories with adequate resources and effective performance through compliance with quality standards
• Scope of the regulations

  • Analysis of human and other related tissues, fluids, secretions, excretions, radioactive, or other materials from the human body to determine existence of pathogenic organisms, pathologic processes or conditions
• The regulations do not include government laboratories doing limited examinations like acid fast bacilli microscopy, malaria screening and cervical cancer screening, if their services are extensions of a licensed government clinical laboratory
• Classification of laboratories


  • Clinical Pathology
  • Anatomic Pathology
  • Hospital-based
  • Non-hospital-based
  • Primary
  • Secondary
  • Tertiary
• Requirements for clinical laboratory construction

  • Approved architectural and design layout secured from BHFS prior to application
  • Construction permit issued by BHFS
• Requirements for clinical laboratory operation

  • Valid license issued by BHFS/CHD based on compliance with minimum licensing requirements
  • Organized and managed to provide effective and efficient services
  • Adequate and appropriate facilities for personnel and clientele
• Documents required for permit to construct application

  • Letter of application
  • 4 sets of site development and floor plans approved by architect/engineer
  • Proof of ownership/lease of property
• Application for new license

  Duly notarized "Petition to Establish, Operate and Maintain a Clinical Laboratory" filed by owner or authorized representative at BHFS
• Application for license renewal

  Duly notarized "Application for Renewal of License to Establish, Operate and Maintain A Clinical Laboratory" filed by owner or authorized representative at respective CHD
• Application for license renewal must be filed 2-4 months before expiry, depending on region
• Each licensee shall make their facility available for inspection by the BHFS/CHD
• Director of BHFS


  Four (4) sets of Site Development Plans and Floor Plans approved by an architect and/or engineer
• Application for new license

  A duly notarized application-form "Petition to Establish, Operate and Maintain a Clinical Laboratory" , shall be filed by the owner or his duly authorized representative at the BHFS
• Application for renewal of license

  A duly notarized application form "Application for Renewal of License to Establish, Operate and Maintain A Clinical Laboratory" , shall be filed by the owner or his duly authorized representative at the respective CHD