Unit 3.2 Nature of Clinical Laboratory PDF

PRAYER BEFORE CLASS Holy Spirit, Divine Creator, true source of light and fountain of wisdom! Pour forth your brilliance upon my dense intellect, dissipate the darkness which covers me, that of sin and of ignorance. Grant me a penetrating mind to understand, a retentive memory, method and ease of le...

PRAYER BEFORE CLASS Holy Spirit, Divine Creator, true source of light and fountain of wisdom! Pour forth your brilliance upon my dense intellect, dissipate the darkness which covers me, that of sin and of ignorance. Grant me a penetrating mind to understand, a retentive memory, method and ease of learning, the lucidity to comprehend, and abundant grace in expressing myself. Guide the beginning of my work, direct its progress and bring it to successful completion. This I ask through Jesus Christ, true God, and true man, living and reigning with You and the Father, forever and ever. Amen.  PRINCIPLES OF MEDICAL TECHNOLOGY PRACTICE 1 NATURE OF THE CLINICAL LABORATORY Outline PART I PART II General Overview Sections in the Clinical Classification of Clinical Laboratory Laboratories Laboratory Testing Cycle Quality Assurance in the Clinical Laboratory PART III Philippine Regulations on Clinical Laboratories Learning Outcome 1. Explain the roles, functions, and services offered by the different sections of the clinical laboratory and understand the law governing their operations. SECTIONS IN THE CLINICAL LABORATORY Sections in the Clinical Laboratory Clinical Chemistry Sections in the Clinical Laboratory Clinical Chemistry - Testing blood and other body fluids to quantify essential soluble chemicals to diagnose certain diseases - Fully automated Tests performed - Fasting blood sugar - Creatinine - Glycosylated hemoglobin - Total protein (HbA1c) - Albumin - Total cholesterol - Electrolytes - Triglycerides - Clinical enzymology - Blood uric acid Sections in the Clinical Laboratory Clinical Chemistry - Testing blood and other body fluids to quantify essential soluble chemicals to diagnose certain diseases Tests performed - Endocrinology (hormones) - Toxicology and drug testing Sections in the Clinical Laboratory Microbiology Sections in the Clinical Laboratory Microbiology - Subdivided into four sections - Bacteriology - Mycobacteriology - Mycology - Virology - Not as automated as clinical chemistry - Blood culture - Antimicrobial susceptibility testing Sections in the Clinical Laboratory Microbiology Test performed - Microscopic visualization of - Quality control and assurance microorganisms and fungi - Infection control - Biochemical tests - Biosafety and proper waste - Antigen typing disposal - Antibacterial susceptibility test - Preparation of culture media and stains Sections in the Clinical Laboratory Hematology and Coagulation Studies Sections in the Clinical Laboratory Hematology and Coagulation Studies - Enumeration of cells in the blood and other body fluids Test performed - Complete blood count - Quantitative platelet count - Hemoglobin - Total cell count and differential - Hematocrit count - WBC differential count - Blood smear preparation - Red cell morphology and cell - Staining other body fluids indices Sections in the Clinical Laboratory Clinical Microscopy Sections in the Clinical Laboratory Clinical Microscopy - Two major areas - Routine and other special examinations of urine - Examination of stool or routine fecalysis Tests performed - Macroscopic examinations - Microscopic examinations - Biochemical determinations - Detection and identification of parasitic worms and ova Sections in the Clinical Laboratory Blood Bank/Immunohematology Sections in the Clinical Laboratory Blood Bank/Immunohematology - Enumeration of cells in the blood and other body fluids - Most critical section Test performed - Blood typing - Compatibility testing - Blood components for transfusion Sections in the Clinical Laboratory Immunology and Serology Sections in the Clinical Laboratory Immunology and Serology - Analyses of serum antibodies in certain infectious agents primarily viral agents) - Automated analyzers are commonly used Test performed - Hepatitis B profile tests - Serological tests for syphilis - Hepatitis C - Dengue fever Sections in the Clinical Laboratory Histopathology/Cytology Sections in the Clinical Laboratory Histopathology/Cytology Test performed - Tissues processing - Cutting into sections - Staining - Preparation for microscopic examination Specialized Sections in the Clinical Laboratory Immunohistochemistry Specialized Sections in the Clinical Laboratory Immunohistochemistry - Combines anatomical, clinical and biochemical techniques where antibodies bound to enzymes and fluorescent dyes to detect presence of antigens in tissue - Assess responses of patients to cancer therapy - Diagnosis of neurodegenerative disorders Test performed - Tumor specific antigens - Oncogenes - Tumor suppressor genes Specialized Sections in the Clinical Laboratory Molecular Biology and Biotechnology Specialized Sections in the Clinical Laboratory Molecular Biology and Biotechnology - DNA and RNA are identified using enzymes and other reagents Test performed - Polymerase chain reaction LABORATORY TESTING CYCLE Three Phases of Laboratory Testing Pre-analytic Phase Laboratory test requisition/order Order reception Patient preparation Specimen collection Specimen transport and processing Three Phases of Laboratory Testing Pre-analytic Phase Laboratory test requisition/order Order reception Patient preparation Specimen collection Analytic Phase Specimen transport Actual testing and processing Three Phases of Laboratory Testing Pre-analytic Phase Laboratory test requisition/order Post-analytic Phase Order reception Data transmission/interpretation Results application Patient preparation TAT Specimen collection Analytic Phase Specimen transport Actual testing and processing  QUALITY ASSURANCE IN THE CLINICAL LABORATORY Quality Assurance in the Clinical Laboratory - All activities performed by the laboratory personnel to ensure reliability of test results - Organized, systematic, well-planned and regularly done with results properly documented and consistently reviewed - Has two major components: - Internal quality assurance system (IQAS) - External quality assurance system (EQAS) Quality Assurance in the Clinical Laboratory Internal Quality Assurance System (IQAS) - Includes day-to-day activities that are undertaken in order to control factors or variable that may affect test results Quality Assurance in the Clinical Laboratory External Quality Assurance System (EQAS) - System for checking performance among clinical laboratories - Facilitated by designated external agencies - National Reference Laboratory is the DOH designated EQAS External Quality Assessment Scheme - Evaluates the performance of participating laboratories - Required under local regulatory policies for securing a External Quality Assessment Program DEPARTMENT OF HEALTH DEPARTMENT MEMORANDUM NO. 2009-OO86-B National Reference Laboratory Research Institute for Tropical Medicine  External Quality Assessment Program DEPARTMENT OF HEALTH DEPARTMENT MEMORANDUM NO. 2009-OO86-B National Reference Laboratory San Lazaro Hospital STD-AIDS Cooperative Center Laboratory External Quality Assessment Program DEPARTMENT OF HEALTH DEPARTMENT MEMORANDUM NO. 2009-OO86-B National Reference Laboratory East Avenue Medical Center External Quality Assessment Program DEPARTMENT OF HEALTH DEPARTMENT MEMORANDUM NO. 2009-OO86-B National Reference Laboratory National Kidney and Transplant Institute External Quality Assessment Program DEPARTMENT OF HEALTH DEPARTMENT MEMORANDUM NO. 2009-OO86-B National Reference Laboratory Lung Center of the Philippines External Quality Assessment Program DEPARTMENT OF HEALTH DEPARTMENT MEMORANDUM NO. 2009-OO86-B External Quality Assessment Program DEPARTMENT OF HEALTH DEPARTMENT CIRCULAR NO. 2017-0173  PRINCIPLES OF MEDICAL TECHNOLOGY PRACTICE 1 NATURE OF THE CLINICAL LABORATORY Formative Assessment 1. A clinical laboratory section that is fully automated and is intended to test blood and other body fluids to quantify soluble chemicals 2. Give 2 tests performed in this clinical laboratory section Formative Assessment 1. A clinical laboratory section that is fully automated and is intended to test blood and other body fluids to quantify soluble chemicals Clinical Chemistry 2. Give 2 tests performed in this clinical laboratory section FBS, HBA1C, Total Cholesterol, TAG, BUA, BUN, Crea, TP, ALBUMIN, Electrolytes, Clinical Enzymology, Endocrinology, Toxicology, Drug Testing Formative Assessment 3. A phase in the laboratory testing that includes receipt of laboratory request, patient preparation. 4. Give two variables present in this phase that may affect test results Formative Assessment 3. A phase in the laboratory testing that includes receipt of laboratory request, patient preparation. Pre-analytical Phase 4. Give two variables present in this phase that may affect test results 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 with regard to volume of anticoagulant. Formative Assessment 5. Two major components of quality assurance in the clinical laboratory Formative Assessment 5. Two major components of quality assurance in the clinical laboratory External Quality Assurance System Internal Quality Assurance System Formative Assessment 6. Give two national reference laboratories and their respective EQAS program Formative Assessment 6. Give two national reference laboratories and their respective EQAS program (at least one) RITM - microbiology, parasitology, tuberculosis, transfusion- transmissible infections San Lazaro Hospital SACCL - HBV, HIV, HCV, Syphilis, other STIs EAMC - drug and water testing NKTI - Hematology Lung Center of the Philippines - Clinical Chemistry References Benitez, P., Dumaoal, O., Estrella, F., Mortel, F., Nava, M. (2019). Principles of Medical Laboratory Science 1. C and E Publishing, Inc. Department of Health Administrative Order No. 2021-0037. New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines. https://hfsrb.doh.gov.ph/wp-content/uploads/2021/06/ao2021-0037-2.pdf. Department of Health Department Memorandum No. 2009-0086B. Amendment to Department Memorandum No.2009-0086A Entitled, “Implementation of External Quality Assessment Program as Regulatory Requirement for Licensing of Clinical Laboratories https://drive.google.com/file/d/1dTDnrlDmHnN7OfPv6MqfB-CTIqg7Gojk/view Department of Health Department Circular No. 2017-0173. Agreement on the New Timelines for the Application and Issuance of Certificates of Performance/Certificate of Proficiency of EQAP Conducted by NRLs https://drive.google.com/file/d/1dTDnrlDmHnN7OfPv6MqfB-CTIqg7Gojk/view