FUNCTIONS OF CLINICAL LABORATORY
Clinical Laboratory
It is a facility for the biological, microbiological, serological, chemical, immune hematological,
hematological, biophysical, cytological, pathological, or other examination of materials derived from
human body for the purpose of providing information for the diagnosis, prevention, or treatment of any
disease. (CLIA 1988)
It is the place where specimens collected from individuals are processed, analyzed, preserved, and
properly disposed
Classification Based on Function
1. Clinical Pathology:
a clinical laboratory that is concerned with the diagnosis and treatment of diseases performed
through laboratory testing of blood and other fluids
It includes tests like:
Hematology
Clinical Chemistry
Microbiology
Parasitology
Mycology
Immunohematology
Immunology/Serology
Lab. Endocrinology
Toxicology
Therapeutic Drugs Monitoring
2. Anatomic Pathology
a clinical laboratory concerned with the diagnosis of diseases through microscopic examination
of tissues and organs.
It encompasses techniques like
Surgical Pathology
Immunohistopathology
Cytology
Autopsy
Forensic Pathology
3. Molecular Pathology
a clinical laboratory concerned with the understanding and diagnosis of diseases at the
molecular level through the analysis of molecules within cells.
Classification of a clinical laboratory by Institutional Character
1. 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 and seafarers, birthing
home, psychiatric facility, drug rehabilitation center, and others.
2. Free Standing Laboratory
A laboratory that is not directly affiliated with a larger institution. They operate as separate
entities and are not tied to a specific academic, healthcare, or governmental organization.
Classification Based on Service Capability
1. Primary clinical laboratory level
Clinical laboratories under this category are licensed to perform basic, routine laboratory testing
Examinations Conducted:
a. Free Standing:
-Routine urinalysis, routine stool examination, routine hematology or complete blood count that
includes hemoglobin, hematocrit, WBC and RBC count, WBC differential count and qualitative platelet
count, blood typing
b. Institution/Hospital-based
- All the others mentioned plus Gram-staining
2. clinical laboratories under
this category are licensed to
perform basic,
3. routine laboratory testing
4. clinical laboratories under
this category are licensed to
perform basic,
5. routine laboratory testing
2. Secondary Clinical laboratory level– clinical laboratories licensed to perform tests being done by the
primary category clinical laboratories along with routine clinical chemistry tests.
Examination Conducted
a. Free Standing
Routine Hematology
Routine Urinalysis
Routine Fecalysis
Routine Clinical Chemistry (blood glucose concentration, blood urea nitrogen, blood uric acid,
blood creatinine, cholesterol determination, qualitative platelet count)
b. Institution/Hospital-based
Routine Hematology
Routine Urinalysis
Routine Fecalysis
Routine Chemistry
Blood Typing and Crossmatching
Quantitative Platelet Determination
Gram staining and KOH mount
3. Tertiary clinical laboratory level-
clinical laboratories licensed to perform tests being done by the secondary clinical laboratories along
with other tests listed below.
Examination Conducted
1. Immunology and serology tests
– NS1-Ag for dengue, rapid
plasma
regin, Treponema pallidum
particle
agglutination tests
2. Microbiology, bacteriology,
mycology
tests
– Differential staining
techniques,
culture and identification of
bacteria
and fungi from from
specimens
1. Immunology and serology tests
– NS1-Ag for dengue, rapid
plasma
regin, Treponema pallidum
particle
agglutination tests
2. Microbiology, bacteriology,
mycology
tests
– Differential staining
techniques,
culture and identification of
bacteria
and fungi from from
specimens
1. Immunology/ Serology tests
NS1-Ag for dengue, rapid plasma regin, Treponema pallidum particle agglutination tests
2. Microbiology, bacteriology, mycology tests
Differential staining techniques, culture and identification of bacteria and fungi from from
specimens antimicrobial susceptibility testing
3. Special Clinical chemistry tests
Clinical enzymology, therapeutic drug monitoring, markers for certain diseases
4. Special Hematology tests
Bone marrow studies, special staining for abnormal cells, red cell morphology
5. Immunohematology and bloodbanking tests
Antibody screening and identification, preparation of blood components, including the blood
donation program.
References:
https://www.studypool.com/documents/7057547/pmls-clinical-laboratory