The Clinical Laboratory
Clinical laboratory |
essential component of health institutions |
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main task: provide accurate and reliable information to medical doctors for the diagnosis, prognosis, treatment, and management of diseases |
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involved in: research, community outreach program, surveillance, infection control in the hospital and community settings, information dissemination, and evaluation of the applicability or current and innovative diagnostic technologies |
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place where specimens (e.g., blood and other body fluids, tissues, feces, hair, nails) collected from individuals are processed analyzed, preserved, and properly disposed. |
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vary according to size, function, and the complexity of tests performed |
Laboratory Test Results |
basis for 70% of all decisions performed by medical doctors |
Medical Technologist/Clinical Laboratory Scientist |
serves as the integral partner of medical doctors |
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important member of the health care delivery system |
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plays a very significant role in the performance of laboratory testing and ensuring the reliability of test results |
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Assays in the past: manual, taxing, labor-intensive, and time-consuming |
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Presently, with the advent of automation: less laborious, with shortened turn around time (TAT) |
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Possible cause of changes in the future: shifting demographics, emergence of new and re-emergence of infectious and non-infectious diseases, demand for more efficient and effective workflow, and new government institutional policies |
CCL: According to Functions
Clinical Pathology |
focuses in the areas of clinical chemistry, immunohematology, and blood banking, medical microbiology, toxicology, therapeutic drug monitory, and endocrinology |
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concerned in the diagnosis and treatment of the diseases performed through laboratory testing of blood and other body fluids |
Anatomic Pathology |
focuses in the areas of histopathology, immunohistopathology, cytology, autopsy, and forensic pathology |
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concerned with the diagnostic of diseases through microscopic examination of tissues and organs |
CCL: According to Institutional Characteristics
Institution-based |
operates within the premises or part of an institution (e.g., hospital, school, medical clinic, medical facility for overseas workers and seafarers, birthing home, psychiatric facility, and drug rehabilitation center) |
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most common example: Hospital-based clinical laboratories |
free-standing |
not part of an established institution |
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Example: free-standing out-patient clinical laboratory |
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CCL: According to Ownership
Government-owned |
owned, wholly or partially, by national or local government units |
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Examples: clinical and anatomical laboratories of DOH-run government hospitals (San Lazaro Hospital, Jose R. Reyes Memorial Medical Center, University of the Philippines-Philippine General Hospital and local government-run hospital-based clinical laboratories of the Ospital ng Maynila Medical Center, Sta. Ana Hospital, and Bulacan Medical Center) |
Privately-owned |
owned, established, and operated by an individual, corporation, institution, association, or organization |
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Examples: St. Luke's Medical Center, Makati Medical Center, and MCU-FDTMF Hospital |
CCL: According to Service Capability
Primary category |
licensed to perform routine laboratory testing (e.g., routine urinalysis and routine stool examination) |
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routine hematology or complete blood count: hemoglobin, hematocrit, WBC and RBC count, WBC differential count and qualitative platelet count, blood typing, and Gram staining (if hospital-based) |
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Equipment: microscopes, centrifuge, and hematocrit centrifuge |
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Space requirement: at least 10 square meters |
Secondary category (Hospital and non-hospital-based) |
licensed to perform laboratory tests being done by the primary category clinical laboratories along with routine clinical chemistry tests |
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routine chemical chemistry tests: blood glucose concentration, blood urea nitrogen, blood uric acid, blood creatinine, cholesterol determination, and qualitative platelet count |
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If hospital-based: Gram stain, KOH mount, and cross-matching |
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Minimum requirement: 20 square meters floor area |
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Personnel requirement: depends on the workload |
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Equipment: microscope, centrifuge, Hematocrit centrifuge, semi-automated chemistry analyzers, autoclave, incubator, and oven |
Tertiary category (Hospital and non-hospital-based) |
licensed to perform all the laboratory tests performed in the secondary category laboratory |
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Immunology and serology: NS1-Ag for dengue, rapid plasma reagin, and Treponema pallidum particle agglutination tests |
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Microbiology, bacteriology, and mycology: differential staining techniques, culture and identification of bacteria and fungi from specimens, and antimicrobial susceptibility testing |
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Special clinical chemistry: clinical enzymology, therapeutic drug monitoring, and markers for certain diseases |
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Special hematology: bone marrow studies, special staining for abnormal blood cells, and red cell orphology |
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Immunohematology and blood banking: blood donation program, antibody screening and identification, and preparation for blood components |
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Minimum floor requirement: at least 60 square meters |
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Equipment: microscope, centrifuge, Hematocrit centrifuge, semi-automated chemistry analyzers, autoclave, incubator, oven, automated chemistry analyzer, biosafety cabinet class II, and serofuge |
National Reference Laboratory |
laboratory in a government hospital designated by the DOH |
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provide special diagnostic functions and services for certain diseases |
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Functions: 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, and training of medical technologists on certain specialized procedures that requires standardization |
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Sections of the Clinical Laboratory
Clinical laboratory |
made up of different sections cohesively and comprehensively performing different activities and procedures for each specimen collected from patient to produce reliable test results |
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Clinical laboratory personnel: pathologists, medical technologists/clinical laboratory scientists, medical technicians, phlebotomists, and other laboratory personnel |
Clinical Chemistry |
intended for testing blood and other body fluids to quantify essential soluble chemicals including waste products useful for diagnosis of certain diseases |
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Most common body fluids: blood and urine |
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Test Performed: fasting blood sugar (FBS), glycosylated hemoglobin (HbA1c - diabetes), total cholesterol - HDL and LDL, triglycerides (TAG) - cardiovascular diseases, blood uric acid (BUA), blood urea nitrogen (BUN), creatinine - diseases involving the kidney, total protein (TP), albumin, electrolytes (sodium, potassium, chloride), clinical enzymology (aminotransferase and creatine kinase) |
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One of the busiest sections of the clinical laboratory |
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characterized as state-of-art, fully automated facility |
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Endocrinology: hormone in blood and urine |
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Thyroid hormone tests: thyroid stimulating hormone (TSH), T3 and T4 (triiodothyronine and thyroxine) |
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Other tests: estrogen, prolactin, and testosterone |
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Other laboratories: Toxicology and Drug Testing |
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Important activities: Internal Quality Assurance (IQA), Continuous Quality Improvement (CQA), and participation in National External Quality Assurance Program (NEQAP) |
Microbiology |
Four major sections: bacteriology, mycobacteriology, mycology, and virology |
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focused on the identification on bacteria and fungi on specimens received |
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Specimens: blood and other body fluids, stool, tissues, and swabs |
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Tests: microscopic visualization of microorganisms after staining, isolation, and identification of bacteria (aerobes and anaerobes) and fungi using varied culture media and different biochemical tests (antigen typing and antibacterial susceptibility testing) |
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Other activities: preparation of culture media and stains, quality assurance and control, infection control, and biosafety and proper waste disposal |
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Mycobacteriology: identification of mycobacterium (e.g., Mycobacterium tuberculosis) |
Hematology and Coagulation Studies |
enumeration of cells in the blood and other body fluids (CSF and pleural fluid) |
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Examinations: CBC, hemoglobin, hematocrit, WBC differential count, red cell morphology, total cell count and differential count, blood smear preparation, and staining for other body fluids |
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Coagulation studies: focuses on blood testing for determination of various coagulation factors |
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Bone marrow examination: performed in automated hematology analyzers |
Clinical Microscopy |
First Area: allotted to routine and other special examinations of urine (macroscopic examination: determine the color, transparency, specific gravity, and pH level and microscopic examination: detect the presence of abnormal cells and/or parasites as well as to quantify red cells and WBC and other chemicals found in urine |
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Second Area: examination of stool or routine fecalysis |
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Routine fecalysis: identification of parasitic worms and ova |
Blood Bank/Immunohematology |
screening for all antibodies and identification of antibodies and blood components used for transfusion |
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Tests: blood typing and compatibility testing |
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most critical in the clinical laboratory |
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Hospital-based clinical laboratories: blood donation activities (donor recruitment and screening, bleeding of donor, and post-donation care |
Immunology and Serology |
analyses of serum antibodies in certain infectious diseases (primarily viral agents) |
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Tests: Hepatitis B profile tests, serological tests for syphilis |
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Antibody screening tests: test for hepatitis C and dengue fever |
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Automated analyzers are also used in this section for different serological tests |
Anatomic Pathology: Section of Histopathology/Cytology |
Activities: tissue processing (removed surgically: biopsy/autopsy), cutting into sections, staining, and preparation for microscopic examination by a pathologist |
Specialized Sections of the Laboratory: Immunohistochemistry |
combines anatomical, clinical, and biochemical techniques where antibodies (monoclonal and polyclonal) bounded to enzymes and fluorescent dyes are used to detect presence of antigens and tissue |
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useful in the diagnosis of some types of cancers by detecting the presence of tumor-specific antigens, oncogenes, and tumor suppressor genes. |
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assess the responses of patients to cancer therapy as well as diagnosis for certain neurodegenerative disorders |
Molecular Biology and Biotechnology |
uses different enzymes and other reagents, DNA and RNA are identified and sequenced to detect any pathologic conditions/disease processes |
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Most common technique: polymerase chain reaction (PCR) - contributed to scientific advancements in laboratory research; useful for clinical techniques (screening genetic indicators of disease & diagnosis of cancer and infectious diseases |
Laboratory Testing Cycle
Laboratory Testing Cycles |
encompasses all activities starting from the medical doctor writing a laboratory request up to the time (called the turnaround time [TAT]) the results are generated and become useful information for the treatment of patients |
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Three phases: pre-analytic, analytic, and post analytic |
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Pre-analytic phase: receipt of laboratory request, patient preparation, specimen collection, and proper transport and processing of specimen to the clinical laboratory |
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Analytic phase: actual testing of the submitted/collected specimen |
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Equipment and instruments: reagents and internal quality control program |
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Post-analytic phase: transmission of test results to the medical doctor for interpretation, TAT, and application of doctor's recommendations; diagnosis and treatments are based in the generated data |
Medical Technologist/Clinical Laboratory Scientist |
Must have clear understanding of the testing cycle to avoid erroneous test results |
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variables may affect the tests results: preparation of the request slip for the patient |
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variables that may cause errors: physiological factors, diet, medications, alcohol and caffeine intake, exercise, underlying disease conditions, identification of patients and labeling of specimens, anticoagulant used, and volume of specimen collected vis-a-vis volume of anticoagulant |
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Post-analytic phase: control of the variables of TAT and transcription errors (e.g., wrong value used, result given to the wrong patient). |
Quality Assurance in the Clinical Laboratory
Quality Assurance |
encompasses all activities performed by laboratory personnel to ensure reliability of test results |
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organized, systematic, well-planned, and regularly done with the results properly documented and consistently reviewed |
Two Major Components |
Internal Quality Assurance System (IQAS) and External Quality Assurance System (EQAS) |
Internal Quality Assurance System (IQAS) |
day-to-day activities that are undertaken in order to control factors or variables that may affect test results |
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Regular review and audit of test results: done to identify weaknesses and consequently perform corrective actions |
External Quality Assurance System (EQAS) |
system for checking performance among clinical laboratories and is facilitated by designated external agencies |
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National Reference Laboratories (NRL): DOH-designated EQAS |
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Unknown sample with known test results -> clinical laboratory for testing -> results returned to external facility -> compared to the known result (determines the performance of the laboratory) |
Certificate of Performance |
given to the participating clinical laboratory |
Designated NRL-EQAS |
National Kidney and Transplant Institute (NKTI) - Hematology and Coagulation |
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Research Institute of Tropical Medicine (RITM) - Microbiology (identification and antibiotic susceptibility testing) and Parasitology (identification of ova and quotation malaria) |
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Lung Center of the Philippines (LCP) - Clinical chemistry (for testing 10 analytes, namely glucose, creatinine, total protein, albumin, blood urea nitrogen, uric acid, cholesterol, sodium, potassium, and chlorine |
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East Avenue Medical Center (EAMC) - Drug of abuse (methamphetamine and cannabinoids) |
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San Lazaro Hospital STD-AIDS Cooperative Center Laboratory (SACCL) - Infectious immunology hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV), Hepatitis C virus (HCV) |
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