PMTP 1 - Lesson 8

• Clinical laboratory - the place where specimens collected from individuals are processed, analyzed, preserved, and properly disposed

  • Blood
  • Other body fluids
  • Tissues
  • Feces
  • Hair
  • Nails
• Clinical laboratory - an essential component of health institutions. Its main task is to provide accurate and reliable information to medical doctors for the diagnosis, prognosis, treatment, and management of diseases.
• Seventy percent of all decisions performed by medical doctors are based on laboratory test results, thus the need for accurate and reliable test results.
• The clinical laboratory is also actively involved in:

  • Research
  • Community outreach programs
  • Surveillance
  • Infection control in the hospital and community settings
  • Information dissemination
  • Evaluation of the applicability of current and innovative diagnostic technologies
• Medical technologist/clinical laboratory scientist - serves as the integral partner of medical doctors and is an important member of the health care delivery system.
• Clinical laboratories vary according to:

  • Size
  • Function
  • Complexity of tests performed
• Medical technologist/clinical laboratory scientist - plays a significant role in the performance of laboratory testing and ensuring the reliability of test results
• Clinical laboratories are classified according to:

  1. According to function
  2. According to Institutional Characteristics
  3. According to Ownership
  4. According to Service Capability
• Classification of Clinical Laboratories according to function:

  • Clinical Pathology
  • Anatomic Pathology
• Clinical Pathology - a clinical laboratory that is concerned with the diagnosis and treatment of diseases performed through laboratory setting of blood and other body fluids
• Clinical Pathology is a clinical laboratory that focuses on the areas of:

  • Clinical Chemistry
  • Immunohematology and Blood banking
  • Medical Microbiology
  • Immunology and Serology
  • Hematology
  • Parasitology
  • Clinical Microscopy
  • Toxicology
  • Therapeutic drug monitoring
  • Endocrinology
• Anatomic Pathology - it is concerned with the diagnosis of diseases through microscopic examination of tissues and organs.
• According to Institutional Characteristics:

  • Institution-based
  • Free-standing
• Institution-based - 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 and seafarers, birthing home, psychiatric facility, drug rehabilitation center, and others.

  • Hospital-based clinical laboratories
• Free-standing - clinical laboratory is not part of an established institution. The most common example is a free-standing out-patient clinical laboratory.
• Government-owned - are owned, wholly or partially, by national or local government units

  • DOH-run government hospitals
• Privately-owned clinical laboratories - are owned, established, and operated by an individual, corporation, institution, association, or organization.

  • St. Luke's Medical Center
  • Makati Medical Center
  • MCU-FDTMF Hospital
• According to Ownership:

  • Government-owned
  • Privately-owned
• According to Service Capability:

  • Primary
  • Secondary
  • Tertiary
  • National Reference Laboratory
• Primary category - clinical laboratories that are licensed to perform basic, routine laboratory testing
• Routine laboratory testing performed in the primary category include:

  • Routine urinalysis
  • Routine stool examination
  • Routine hematology
  • Complete Blood Count (CBC) including: hemoglobin, hematocrit, WBC and RBC count, WBC differential count and qualitative platelet count, blood typing, Gram staining.
• Secondary category - are clinical laboratories that are licensed to perform laboratory tests being done by the primary category clinical laboratories along with routine clinical chemistry tests
• Equipment requirements under the primary category:

  • Microscopes
  • Centrifuge
  • Hematocrit centrifuge
• 10 square meters - space requirement of a primary category clinical laboratories
• Tests performed in the secondary category clinical laboratories:

  • Blood glucose concentration
  • Blood urea nitrogen (BUN)
  • Blood uric acid
  • Blood creatinine
  • Cholesterol determination
  • Qualitative platelet count
  • Gram stain (hospital-based)
  • KOH mount
  • Crossmatching
• KOH mount - is a test performed on a secondary category clinical laboratory that is used to identify the presence of fungi
• Tertiary category - licensed to perform all the laboratory tests performed in the secondary category laboratory plus:

  • Immunology and serology
  • Microbiology, bacteriology, and mycology
  • Special clinical chemistry
  • Special hematology
  • Immunohematology and blood banking
• Examples of tests performed in tertiary category, Immunology and Serology:

  • NS1-Ag for dengue
  • Rapid plasma reagin
  • Treponema pallidum particle agglutination tests
• 20 square meters - a minimum space requirement in a secondary category clinical laboratory
• Minimum equipment requirements for secondary category clinical laboratories:

  • Microscopes
  • Centrifuge
  • Hematocrit centrifuge
  • Semi-automated chemistry analyzers
  • Autoclave
  • Incubator
  • Oven
• Examples of tests performed in tertiary category, Microbiology, Bacteriology, and Mycology:

  • Differential staining techniques
  • Culture and Identification of bacteria and fungi from specimens
  • Antimicrobial susceptibility testing
• Examples of tests performed in tertiary category, Special Clinical Chemistry:

  • Clinical enzymology
  • Therapeutic drug monitoring
  • Markers for certain diseases
• Examples of tests performed in tertiary category, Special hematology:

  • Bone marrow studies
  • Special staining for abnormal blood cells
  • Red cell orphology
• Examples of tests performed in tertiary category, Immunohematology and Blood banking:

  • Blood donation program
  • Antibody screening and Identification
  • Preparation of blood components
• 60 square meters - minimum floor area requirement for a tertiary category clinical laboratories
• Equipment requirements in the tertiary category clinical laboratories:

  • Equipments seen in the secondary category
  • Automated chemistry analyzer
  • Biosafety Cabinet Class II
  • Serofuge
• National Reference Laboratory - a laboratory in a government hospital designated by the DOH to provide special diagnostic functions and services for certain diseased. These functions include:

  • Referral services
  • Provision of confirmatory testing
  • Assistance for research activities
  • Implementation of External Quality Assurance Programs (EQAP) of the government
  • Resolution of conflicts regarding test results of different laboratories
  • Training of Medical Technologists on certain specialized procedures that require standardization
• Republic Act No. 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.
• Republic Act No. 4688 was approved on:

  • June 18, 1966
• Administrative Order No. 59 s. 2001 - Rules and Regulation Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines