Clinical Laboratory Licensing Flashcards
Facility where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis, and treatment of diseases.
CLINICAL LABORATORY
Disciplines of Clinical Laboratory Tests
Twelve (12)
- Clinical Chemistry
- Hematology
- Immunohematology/Blood Bank
- Microbiology
- Immunology/Serology
- Clinical Microscopy
- Histopathology
- Cytology
- Toxicology
- Endocrinology
- Molecular Biology
- Cytogenetics
Regulation of Clinical Laboratories
Any person, firm or corporation, operating and maintaining a clinical laboratory shall register and secure a license * at the *
- Annually
- Office of the Secretary of Health
Regulation of Clinical Laboratories
What are EXEMPTED FROM REGISTRATION?
Government hospital laboratories whose services are extensions of government regional or central laboratories
CLASSIFICATION OF LABORATORIES
BASED ON OWNERSHIP
- Government
- Private
CLASSIFICATION OF LABORATORIES
BASED ON FUNCTION
- Clinical Pathology
- Anatomic Pathology
CLASSIFICATION OF LABORATORIES
BASED ON INSTITUTIONAL CHARACTER
- Institutional-based
- Free Standing
CLASSIFICATION OF LABORATORIES
BASED ON SERVICE CAPABILITY
- Primary
- Secondary
- Tertiary
- Limited
CLASSIFICATION OF CLINICAL LABORATORIES
Operated and maintained (partially or wholly) by the national government, a local government unit (provincial, city, or municipal), any other politic unit or any department, division, board, or agency
ACCORDING TO OWNERSHIP
GOVERNMENT LABORATORY
CLASSIFICATION OF CLINICAL LABORATORIES
Owned, established, and operated by any individual, corporate, association, or organization
ACCORDING TO OWNERSHIP
PRIVATE LABORATORY
CLASSIFICATION OF CLINICAL LABORATORIES
- Clinical Chemistry
- Clinical Microscopy
- Hematology
- Molecular Biology
- Immunohematology
- Cytogenetics
- Microbiology
- Toxicology
- Immunology
- Endocrinology
- Therapeutic Drug Monitoring
ACCORDING TO FUNCTION
CLINICAL PATHOLOGY LABORATORY
CLASSIFICATION OF CLINICAL LABORATORIES
- Surgical Pathology
- Autopsy
- Immunohistopathology
- Forensic Pathology
- Cytology
- Molecular Pathology
ACCORDING TO FUNCTION
ANATOMIC PATHOLOGY LABORATORY
CLASSIFICATION OF CLINICAL LABORATORIES
- Routine hematology (CBC)
- Qualitative platelet determination
- Routine urinalysis and fecalysis
- Blood typing (for hospital-based labs)
ACCORDING TO SERVICE CAPABILITY
PRIMARY
CLASSIFICATION OF CLINICAL LABORATORIES
- Tests provided by a primary category laboratory
- Routine clinical chemistry (glucose, BUN, uric acid, creatinine, total cholesterol)
- Quantitative platelet determination
- Crossmatching, Gram staining, KOH (for hospital-based)
ACCORDING TO SERVICE CAPABILITY
SECONDARY
CLASSIFICATION OF CLINICAL LABORATORIES
- Tests provided by primary and secondary category labs
- Special chemistry
- Special hematology (coagulation tests)
- Immunology
- Microbiology – Culture and Sensitivity
*Aerobic AND anaerobic (hospital-based) - Aerobic OR anaerobic (non-hospital based)
ACCORDING TO SERVICE CAPABILITY
TERTIARY