UNIT 3: The Clinical Laboratory - Vocabulary Flashcards

3.1 Classification of Clinical Laboratories (DOH Administrative Order no. 2021-0037)

  • ILOs (Intended Learning Outcomes) for classification:

    • ILO 1: Classify clinical laboratories based on ownership, function, and service capabilities.

    • ILO 2: Discuss the different types of services each type of laboratory offers.

  • A. Classification by Ownership

    • a.1 Government

    • A government is responsible for operation and maintenance of various services and functions, which may be conducted by different levels of governance (national, local government units, provincial/colitical entities) and other departments, boards, or agencies.

    • National Government Responsibilities-

      1. Establishing policies and regulations for clinical laboratory practice (standardization and quality across the country).

      2. Licensing and accreditation of clinical laboratories (oversight of compliance).

      3. Funding and resource allocation for clinical laboratory infrastructure, equipment, and personnel.

    • Local Government Responsibilities-

      1. Implementation and enforcement of national policies and regulations in clinical laboratories.

      2. Public health initiatives using clinical laboratory services to monitor disease outbreaks.

      3. Community engagement and health education about laboratory services.

    • Other Political Entities and Departments-

      1. Health departments overseeing services and compliance.

      2. Laboratory regulatory agencies for inspections and safety.

      3. Professional boards regulating practice standards.

    • a.2 Private

    • Private laboratories are owned/operated by individuals or groups, funded by various sources (private investment, charitable donations, organizational backing).

    • Key Characteristics of Private Clinical Laboratories-

      1. Independent ownership with autonomy in decisions.

      2. Diverse funding sources (private investment, charitable donations, organizational backing).

      3. Focused mission or niche (specialized testing or research).

      4. Potential for innovation and adoption of new technologies.

      5. Competitive market dynamics driving quality and efficiency.

  • B. Classification by Institutional Character

    • b.1 Institution-based laboratory

    • Located within a health facility licensed by the DOH; integrated with facility healthcare services; collaboration with clinicians; capacity varies by institution size.

    • b.2 Non-institution based (Freestanding)

    • Autonomous laboratory not affiliated with a health facility; DOH-licensed; can pursue independent protocols and innovative techniques; subject to government regulation and safety/quality standards.

  • C. Classification by Function

    • c.1 Clinical Pathology Laboratories

    • Clinical Pathology analyzes blood and body fluids to diagnose/manage diseases; areas include:

      1. Clinical Chemistry: Biochemical analysis of electrolytes, enzymes, hormones, metabolites; used for organ function, metabolic disorders; techniques include spectrophotometry and chromatography.

      2. Hematology: Analysis of blood cells (red, white, platelets); diagnoses anemia, leukemia, clotting disorders; techniques include automated cell counting and manual differentials.

      3. Microbiology: Identification of infectious agents (bacteria, viruses, fungi, parasites) in body specimens; includes culture, sensitivity testing, and molecular diagnostics.

      4. Immunohematology (Blood Banking): Blood typing, cross-matching, antibody screening; ensures safe blood transfusions.

      5. Urinalysis and Body Fluid Analysis: Physical, chemical, and microscopic examination of urine and other body fluids (e.g., CSF, synovial fluid); diagnoses kidney disease, UTIs, and other conditions.

    • c.2 Anatomic Pathology Laboratories

    • Anatomic Pathology involves the examination of tissues and organs to diagnose diseases, primarily cancer; areas include:

      1. Histopathology: Microscopic examination of biopsies and surgical resections; involves tissue processing, embedding, sectioning, and staining.

      2. Cytopathology: Examination of individual cells from smears (e.g., Pap tests) or fluid samples to detect abnormalities.

      3. Autopsy Pathology: Post-mortem examination to determine cause of death and study disease progression.

      4. Immunohistochemistry: Uses antibodies to detect specific antigens in tissue samples for precise diagnosis and prognosis.

      5. Molecular Pathology: Genetic and molecular analysis of tissues to detect specific markers, often used in cancer diagnosis and personalized