Clinical Laboratory Categories & Sections (2) PDF

THE CLINICAL LABORATORY By: SWU PHINMA CMT PMLS 1 TEAM LEARNING OBJECTIVES  Compare the different classification of the laboratory as per category Distinguish properly the classification of a clinical laboratory based on services offered.  Identify the different sections in the cli...

THE CLINICAL LABORATORY By: SWU PHINMA CMT PMLS 1 TEAM LEARNING OBJECTIVES  Compare the different classification of the laboratory as per category Distinguish properly the classification of a clinical laboratory based on services offered.  Identify the different sections in the clinical laboratory, test performed, and apparatus used Explain clearly the specific functions and types of tests conducted in key sections of a clinical laboratory, such as Hematology, Microbiology, Clinical Chemistry, Clinical Microscopy, Immunology & Serology, Histopathology, and the Blood Bank. Analyze effectively how different sections of a clinical laboratory interact and collaborate to ensure accurate and efficient processing of samples and reporting of results. CLINICAL LABORATORY ◦ A clinical laboratory isa place where specimens from the human body may be collected, processed, examined or analyzed ◦Its main task is to provide accurate information to doctors for diagnosis, prognosis and treatment of disease ◦ Actively involved in research, infection control, information evaluation and innovative diagnostic technologies. PURPOSE OF LABORATORY -provide physicians and health care professionals with information to:  detect disease or predisposition to disease  confirm or reject a diagnosis  establish prognosis  Guide patient management  Monitor efficacy of therapy QUICK QUESTION 1 Who plays a very significant role in the performance of laboratory setting and ensuring the reliability of test results? ANSWER: MEDICAL TECHNOLOGIST/ CLINICAL LABORATORY SCIENTIST  CLASSIFICATION OF CLINICAL LABORATORY  According to Function According to Institutional Characteristics  According to Ownership  According to Service Capability  CLINICAL LABORATORY According to Function 1. CLINICAL PATHOLOGY  focuses on the areas of  Clinical Chemistry  Blood banking  Microbiology  Immunology and Serology  Hematology  Serology  Parasitology  Clinical Microscopy  Toxicology  Therapeutic drug monitoring  Endocrinology  Concerned with the diagnosis and treatment of disease through laboratory testing of blood and other body fluids.  CLINICAL LABORATORY According to Function 2. ANATOMIC PATHOLOGY  focuses on the areas of  Histopathology  Immunohistopathology  Cytology  Autopsy  Surgical Pathology  Forensic Pathology  Concerned with the diagnosis and treatment of disease through microscopic examination of tissues and organs  CLINICAL LABORATORY According to Instructional Characteristics 1. INSTITUTION-BASED  Operates within the premises of an institution such as  Hospital  School  Medical Clinic  Medical facility for overseas workers and seafarers  Birthing home  Psychiatric facility  Drug Rehabilitation center  Hospital-based laboratory is the most common example  CLINICAL LABORATORY According to Instructional Characteristics 1. FREE-STANDING  Not part of an established institution  Free-standing Out-patient Clinical laboratory is the most common example  CLINICAL LABORATORY According to Ownership 1. GOVERNMENT-OWNED  Owned wholly or partially, by national or local government units  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  Local government-run hospital-based clinical laboratories Ospital ng Maynila Medical Center Sta. Ana Hospital Bulacan Medical Center  CLINICAL LABORATORY According to Ownership 2. PRIVATELY-OWNED  Owned, established, and operated by an individual, corporation, institution, association, or organization  St. Luke’s Medical Center  Makati Medical Center  MCU-FDTMF Hospital  CLINICAL LABORATORY According to Service Capability 1. PRIMARY CATEGORY  Licensed to perform basic, routine laboratory testing such as  Routine Urinalysis  Routine Fecalysis  Routine Hematology  Complete Blood Count 1. Hemoglobin 2. Hematocrit 3. WBC count 4. RBC count 5. WBC differential count 6. Qualitative platelet count  Blood typing  Gram staining (if hospital-based)  Equipment requirements are but not limited to 1.microscopes, 2.centrifuge, 3.HCT centrifuge  Space requirement is at least 10 square meters  CLINICAL LABORATORY According to Service Capability 2. SECONDARY CATEGORY  Licensed to perform tests done by PRIMARY LABORATORIES along with  Clinical Chemistry 1. Blood Glucose Concentration 2. Blood Urea Nitrogen 3. Blood Uric Acid 4. Blood Creatinine 5. Cholesterol Determination 6. Total protein Mass Concentration  Microbiology (if Hospital-based) 1. Gram Stain 2. KOH Mount  Blood bank (if Hospital-based) 1. Crossmatching  CLINICAL LABORATORY According to Service Capability 2. SECONDARY CATEGORY  Minimum equipment requirements are 1.Microscope, 2.centrifuge, 3.Hematocrit centrifuge, 4.Semi-automated analyzers, 5.autoclave, 6.incubator and 7.oven  Space requirement is at least 20 square meters  CLINICAL LABORATORY According to Service Capability 3. TERTIARY CATEGORY  Licensed to perform all the laboratory tests done by SECONDARY LABORATORY along with  Immunology and Serology 1.NS1-Ag for Dengue  Microbiology, Bacteriology & Mycology 1. Differential staining 2. Culture and Identification of bacteria and fungi 3. Antimicrobial Susceptibility testing  Special Clinical Chemistry 1. Clinical Enzymology 2. Therapeutic drug monitoring 3. Markers for certain diseases  Special Hematology 1. Bone marrow studies 2. Special staining for abnormal blood cells 3. Red cell morphology  Immunohematology and Blood Banking 1. Blood donation program 2. Antibody screening 3. Identification and Preparation of blood components   CLINICAL LABORATORY According to Service Capability 3. TERTIARY CATEGORY  Equipment requirements include those seen in secondary laboratories along with 1.Automated Chemistry Analyzer, 2.Biosafety cabinet class II, and 3.Serofuge.  Space requirement is at least 60 square meters  CLINICAL LABORATORY According to Service Capability 4. NATIONAL REREFENCE LABORATORY  A laboratory in a government hospital designated by the DOH to provide special diagnostic functions and services for certain diseases  Functions include  referral services  provision of confirmatory testing  Assistance for research activities  Implementation of External Quality Assurance Programs ( EQAP)  Resolution of conflicts regarding test results of different laboratories  Training of Medical Technologists on certain specialized procedures NATIONAL REFERENCE LABORATORIES IN THE PHILIPPINES San Lazaro Hospital (SACCL) HIV and other STDs East Avenue Medical Center For Environmental and occupational health; toxicology and micronutrient assay National Kidney and Transplant Hematology inc. Immunohematology ang Immunopathology and Anatomic Pathology Institute Philippine Heart Center Pathology for Cardiac Disease Lung cancer of the Philippines Atomic pathology for pulmonary disease Research Institute for Tropical Dengue, Influenza, TB, and other Mycobacteria, Malaria and other parasites, Bacterial enteric Medicine disease. Measles and other viral exanthems, Mycology, Enteroviruses, Antimicrobial resistance and engineering disease QUICK QUESTION 2 Classify SWU-Medical Center Clinical Laboratory according to  Institutional Characteristics  Ownership  Service Capability ANSWER: SWU-MC laboratory is an institutional-based, privately-owned tertiary hospital. LAWS OF THE OPERATION, MAINTENANCE, AND REGISTRATION OF CLINICAL LABORATORIES IN THE PHILIPPINES  REPUBLIC ACT NO. 4688: Clinical Laboratory Act of 1966  ADMINISTRATIVE ORDER NO. 59 s. 2001 ◦ Act regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the department of health, providing REPUBLIC ACT penalty for the violation thereof, and for other purposes. NO. 4688: ◦ PURPOSE: Clinical ◦ To protect and promote the health of the people by ensuring availability of clinical laboratories that are Laboratory properly managed with adequate resources, with effective and efficient performance through Act of 1966 compliance with quality standards ◦ Approved on June 18, 1966  ADMINISTRATIVE ORDER ◦ “Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories NO. 59 s. 2001 in the Philippines” ◦ Created to implement R.A. 4688  Application for permit to construct 1. Letter of Application to the BHFS Director ADMINISTRATIVE 2. Four sets of Site Development Plans and Floor Plans approved by an architect and/or engineer ORDER 3. DTI/SEC Registration (for private clinical laboratory NO. 59 s. 2001  Application for new license SECTION 7: Requirements and 1. Duly notarized form “Petition to Establish, Operate, and Procedures for Application of Maintain a Clinical Laboratory” filed at the BHFS Permit to Construct and  Application for renewal of license License to Operate 1. Duly notarized form “Application for Renewal of License to Establish, Operate and Maintain a Clinical Laboratory” filed at respective CHD 2. Shall be filed 90 days before the expiry of license  Operation of a laboratory without a certified pathologist or ADMINISTRATIVE without a registered medical technologist ORDER  Change of ownership, location, head of laboratory without informing the BHFS and/or CHD NO. 59 s. 2001  Refusal to allow inspection of laboratory SECTION 8: Violations  Gross negligence and any act or omission detrimental to the public  ADMINISTRATIVE  Any person found violating the provisions of RA 4688, shall suspend, cancel or revoke for a determined period of time ORDER the license, as well as authority of the offending person/s.  Any person who operates a clinical laboratory without NO. 59 s. 2001 SECTION 9: Investigation of proper license from DOH shall upon conviction be subject to imprisonment for not less than 1 month but not more than 1 Charges or Complaints year OR a fine of no less than P1000 and not more than P5000 or both at the discretion of the court TECHNICAL STANDARDS AND MINIMUM REQUIREMENTS  1. STAFFING HEAD  Managed by a licensed physician certified by the Philippine Board of Pathology  If Pathologists are not available, a Physician with 3 months training on Clinical Laboratory Medicine, Quality Control and Laboratory Management may manage a PRIMARY and SECONDARY laboratory QUICK QUESTION 3 A Certified Pathologist may be authorized to manage or supervised in not more than Clinical laboratories/ Blood banks.  Answer: 4 laboratories/ blood banks  STAFFING PERSONNEL  Shall have sufficient number of Medical Technologies proportional to the workload and be available at all times during hours of operation.  In hospital-based laboratory, there shall be at least (1) Medical Technologist per shift to cover the operation.  2. PHYSICAL FACILITIES 1. It should be well-ventilated, adequately lighted, safe and clean 2. The space shall accommodate its activities and allow for smooth workflow. 3. The place to work in shall have an adequate water supply 4. Shall have the following measurements: CATEGORY Space in sq.m PRIMARY 10 SECONDARY 20 TERTIARY 60  3.EQUIPMENT/INSTRUMENT PRIMARY SECONDARY TERTIARY Clinical centrifuge All those in 1 ̊plus All those in 2 ̊plus the ff: the ff: Hemacytometer Refrigerator Incubator Microhematocrit Photometer or Balance centrifuge equivalent Microscope w/ oil Waterbath or Rotator equivalent Hemoglobinometer Timer or equivalent Serofuge or or equivalent equivalent Differential counter Autoclave or equivalent Drying oven Biosafety cabinet (BSC) or equivalent 4.QUALITY CONTROL PROGRAM  INTERNAL QUALITY CONTROL PROGRAM  There shall be a documented, continuous competency assessment program for all laboratory personnel  The program shall provide appropriate and standard laboratory methods, reagents and equipment  There shall be a program for the proper maintenance and monitoring of all equipment  The program shall provide for the use of quality control reference materials  EXTERNAL QUALITY CONTROL PROGRAM  All laboratories shall participate in an External Quality Assurance Program given by National Reference Laboratories and other reference laboratories  A satisfactory performance rating given by a National Reference Laboratory shall be one of the criteria for the renewal of license  Any refusal to participate in an EQAP given by NRL shall be one of the bases for suspension/ revocation of the license of the laboratory  Sections of the CLINICAL LABORATORY SECTIONS IN THE CLINICAL LABORATOR Y CLINICAL CHEMISTRY  Testing blood and other body fluids to quantify essential soluble chemicals such as waste products  Urine and Blood are the 2 most common fluids  One of the busiest sections, state-of-the-art, fully automated facility  Examples of tests performed: 1. Fasting Blood Sugar (FBS) 2. Glycosylated Hemoglobin (HbA1c) – diagnosis of diabetes 3. HDL and LDL 4. Triglycerides (TAG) – diagnosis of cardiovascular diseases 5. Uric Acid (BUA) 6. Blood Urea Nitrogen (BUN) 7.Creatinine 8.Total Protein (TP)  MICROBIOLOGY  Subdivided into four sections: 1. Bacteriology – culture (c/s), gram staining (g/s), KOH 2. Mycobacteriology – fungal sensitivity and culture 3.Mycology – fungi identification only 4. Virology – virus identification  Identification of bacteria and fungi on specimens received (usually blood and other fluids, stool, tissues, and swabs from different sites in the body  HEMATOLOGY  Enumeration of cells in the blood and other body fluids (e.g., CSF, pleural fluid, etc.)  Examinations done: 1. CBC 2. Hemoglobin 3. Hematocrit 4. WBC differential count 5. Red cell morphology and cell indices 6. Quantitative platelet count 7. Total cell count and differential count 8. Blood smear preparation 9.Staining for other fluids  CLINICAL MICROSCOPY  Two major areas: 1. Routine and special examination of urine 2. Examination of stool (routine fecalysis)  BLOOD BANK  Blood typing and compatibility testing are the two main activities Other tests performed: 1. Antibodies screening and identification, blood components for transfusion. 2. If hospital-based laboratories: ◦ donor recruitment and screening bleeding of donor, post- donation care IMMUNOLOGY AND SEROLOGY  Analyses of serum antibodies in certain infectious agents (primarily viral agents) Antigen and antibodies testing Antibody screening tests: 1.Hepatitis B profile tests 2.Serological tests for syphilis 3.Hepatitis C tests 4.Dengue fever  ANATOMIC PATHOLOGY Histopathology and Cytology  Tissue processing  Cutting into sections  Staining  Preparation of microscopic examination by a pathologist SPECIALIZED SECTIONS Immunochemistry  Combines anatomical, clinical, and biochemical techniques where antibodies (monoclonal and polyclonal) bounded to enzymes and dyes are used to detect presence of antigens in tissue  Useful in diagnosis of some types of cancers and certain neurodegenerative disorders, and assessment of patients’ responses to cancer therapy Molecular Biology and Biotechnology  One of the exciting developments in medical technology  DNA & RNA identification and detection of any pathologic conditions/disease (enzymes and reagent are used)  Polymerase chain reaction (PCR) – most common technique currently in use QUICK QUESTION 4 What section is considered as the most critical in the clinical laboratory (faulty cross-matching may cause patient’s death?  Answer: BLOOD BANK  LABORATORY TESTING CYCLE Encompasses all activities starting from a medical doctor writing a laboratory request up to the time (turn-around time [TAT]) the results are generated for treatment and management of patients. Medical technologists should have a clear understanding of the testing cycle to prevent erroneous test results Has three phases: Pre-analytic, analytic, and post-analytic  PRE-ANALYTICAL ANALYTICAL POST-ANALYTICAL PHASE PHASE PHASE 1. Laboratory Test Order/ Requisition 1. Equipment and instruments 1. DataTransmission/ interpretation 2. Order Reception 2. Quality or reagents used 2. Results Application 3. Patient Preparation 3. Internal quality control 3.Turn-Around Time (TAT) 4. Specimen Collection program 5. Specimen transport and Processing QUICK QUESTION 4 Identify if the error is Pre- Analytical, Analytical or Post- analytical phase error a.Incorrect patient Identification b.Incomplete lab results c. Instrument malfunction Answer: a. Pre-analytical b.Post-analytical c.Analytical THANK YOU!! HOPE YOU LEARNED SOMETHING! REFERENCES Moraleta, N.D. (2015) The Medical Technology Profession and the Philippine Laws on Medical Technology Mcpherson,R.A. & Pincus,M.R. (2012) Henry’s Clinical Diagnosis and Management by Laboratory Metheds (22nd Ed.) Philadelphia: ElsevierInc