MTPLMSP111 Principles Of Medical Laboratory Science PDF

MTPMLSP111 – PRINCIPLES OF MEDICAL LABORATORY SCIENCE LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA VERDE, E.J. | 1MT03 LESSON 8: NATURE OF THE CLINICAL LABORATORY...

MTPMLSP111 – PRINCIPLES OF MEDICAL LABORATORY SCIENCE LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA VERDE, E.J. | 1MT03 LESSON 8: NATURE OF THE CLINICAL LABORATORY o Evaluation of the applicability of current and innovative diagnostic technologies Medical Technologist / Clinical Laboratory Scientist OUTLINE o Significant role in the performance of lab testing and ensuring the reliability of test results 8.1 The Clinical Laboratory o Integral partner of medical doctors & important 8.2 Classification of Clinical Laboratories member of the health care delivery system 8.2.1 According to Function 8.2.2 According to Institutional Characteristics 8.2.3 According to Ownership 8.2 CLASSIFICATIONS OF CLINICAL LABORATORIES 8.2.4 According to Service Capability 8.3 Laws on the Operation, Maintenance, and Registration of Clinical Laboratories in the Philippines 1. According to Function 8.3.1 Republic Act No. 4688 2. According to Institutional Characteristics 8.3.2 Administrative Order No. 59 Series of 2001 3. According to Ownership 8.3.3 Annex A 4. According to Service Capability 8.4 Sections of the Clinical Laboratory 8.4.1 Clinical Chemistry 8.4.2 Microbiology 8.2.1 ACCORDING TO FUNCTION 8.4.3 Hematology and Coagulation Studies 8.4.4 Clinical Microscopy 8.4.5 Blood Bank/Immunohematology 1. Clinical Pathology 8.4.6 Immunology and Serology Focuses on the areas of: 8.5 Anatomic Pathology o Clinical Chemistry 8.5.1 Section of Histopathology/Cytology 8.6 Specialized Sections of the Laboratory o Immunohematology and Blood Banking 8.6.1 Immunohistochemistry o Medical Microbiology 8.6.2 Molecular Biology and Biotechnology o Immunology and Serology 8.7 Laboratory Testing Cycle o Hematology 8.8 Quality Assurance in the Clinical Laboratory o Parasitology o Clinical Microscopy o Toxicology 8.1 THE CLINICAL LABORATORY o Therapeutic Drug Monitoring o Endocrinology Concerned with the diagnosis and treatment of Clinical Laboratory diseases performed through lab testing of blood and Place where specimens (blood, and other bodily fluids, other body fluids tissues, feces, hair, nails) collected from individuals are 2. Anatomic Pathology processed, analyzed, preserved, and properly disposed Focuses on the areas of: Varies according to size, function, and the complexity of tests o Histopathology performed o Immunohistopathology Essential component of health institutions o Cytology Main task: provide accurate and reliable info to doctors for the o Autopsy diagnosis, prognosis, treatment, and management of diseases o Forensic Pathology 70% of decisions performed by MDs are based on lab test Concerned with the diagnosis of diseases through results microscopic examination of tissues and organs Actively involved in: o Research o Community outreach programs 8.2.2 ACCORDING TO INSTITUTIONAL CHARACTERISTICS o Surveillance o Infection control in hospital and community settings 1. Institution-Based o Information dissemination Operates within the premises of part of an institution: o Hospital 1  MTPMLSP111 – PRINCIPLES OF MEDICAL LABORATORY SCIENCE LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA VERDE, E.J. | 1MT03 o School o Centrifuge o Medical clinic o Hematocrit centrifuge o Medical facility for overseas workers and Space requirement – at least 10 sq m seafarers 2. Secondary Category (Hospital and Non-Hospital-Based) o Birthing home Licensed to perform lab tests being done by the o Psychiatric facility primary category, along with routine clinical chemistry o Drug rehab center tests: Most common: hospital-based clinical labs o Blood glucose concentration 2. Free-Standing o Blood urea nitrogen Not part of an established institution o Blood uric acid Most common: free-standing out-patient clinical lab o Blood creatinine o Cholesterol determination o Qualitative platelet count 8.2.3 ACCORDING TO OWNERSHIP o Gram-stain (hospital-based) o KOH mount (hospital-based) o Crossmatching (hospital-based) 1. Government-Owned Personnel requirement – depends on the workload Owned, wholly or partially by national or local Minimum equipment requirements: government units o Microscopes Examples: o Centrifuge o San Lazaro Hospital o Hematocrit centrifuge o Jose R. Reyes Memorial Medical Center o Semi-automated chemistry analyzers o UP-Philippine General Hospital o Autoclave o Ospital ng Maynila Medical Center o Incubator o Sta. Ana Hospital o Oven o Bulacan Medical Center Minimum space requirement – 20 sq m 2. Privately-Owned 3. Tertiary Category (Hospital and Non-Hospital-Based) Owned, established, and operated by an individual, Licensed to perform all the lab tests performed in the corporation, institution, association, or organization secondary category plus: Examples: o Immunology and serology (NS1-AG for o St. Luke’s Medical Center dengue, rapid plasma regain, Treponema o Makati Medical Center pallidum particle agglutination tests) o MCU-FDTMF Hospital o Microbiology, bacteriology, and mycology (differential staining techniques, culture and 8.2.4 ACCORDING TO SERVICE CAPABILITY identification of bacteria and fungi from specimens, antimicrobial susceptibility testing) o Special clinical chemistry (clinical enzymology, 1. Primary Category therapeutic drug monitoring, markers for Licensed to perform basic, routine lab testing: certain diseases) o Routine urinalysis o Special hematology (bone marrow studies, o Routine stool examination special staining for abnormal blood cells, red o Routine hematology cell morphology) o Complete blood count: o Immunohematology and blood banking (blood ▪ Hemoglobin donation program, antibody screening and ▪ Hematocrit identification, preparation of blood ▪ WBC and RBC count components) ▪ Qualitative platelet count Equipment requirements: ▪ Blood typing o Secondary category ▪ Gram staining (hospital-based) o Automated chemistry analyzer Equipment requirements (not limited): o Biosafety cabinet class II o Microscopes o Serofuge 2  MTPMLSP111 – PRINCIPLES OF MEDICAL LABORATORY SCIENCE LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA VERDE, E.J. | 1MT03 Minimum space requirement – 60 sq m No license shall be granted or renewed by the Secretary of Health 4. National Reference Laboratory for the operation and maintenance of a clinical laboratory unless Laboratory in a government hospital designated by the such laboratory is under the administration, direction and DOH to provide special diagnostic functions and supervision of an authorized physician, as provided for in the services for certain diseases preceding paragraph. Functions: o Referral services SECTION 3. The Secretary of Health, through the Bureau of o Provision of confirmatory testing Research and Laboratories shall be charged with the responsibility o Assistance for research activities of strictly enforcing the provisions of this Act and shall be o Implementation of External Quality Assurance authorized to issue such rules and regulations as may be necessary Programs (EQAP) of the government to carry out its provisions. o Resolution of conflicts regarding test results of SECTION 4. Any person, firm or corporation who violates any diff labs provisions of this Act or the rules and regulations issued thereunder o Training of medtechs on certain specialized by the Secretary of Health shall be punished with imprisonment for procedure that require standardization not less than one month but not more than one year, or by a fine of not less than one thousand pesos nor more than five thousand 8.3 LAWS ON THE OPERATION, MAINTENANCE, AND pesos, or both such fine and imprisonment, at the discretion of the REGISTRATION OF CLINICAL LABORATORIES IN THE court. PHILIPPINES SECTION 5. If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgment shall 8.3.1 REPUBLIC ACT NO. 4688 not affect, impair, or invalidate the remainder thereof. SECTION 6. The sum of fifty thousand pesos, or so much thereof Republic Act No. 4688 – Clinical Laboratory Act as may be necessary, is hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to An act regulating the operation and maintenance of clinical carry into effect the provisions of this Act. laboratories and requiring the registration of the same with the Department of Health, providing penalty for the violation SECTION 7. All Acts or parts of Acts which are inconsistent with the thereof, and for other purposes provisions of this Act are hereby repealed. Approved on June 18, 1966 SECTION 8. This Act shall take effect upon its approval. Signed by Ferdinand E. Marcos Promulgated for the purpose of preventing the operation and maintenance of substandard, improperly managed and 8.3.2 ADMINISTRATIVE ORDER NO. 59 S. 2001 poorly-equipped clinical laboratories SECTION 1. Any person, firm or corporation, operating and Administrative Order No. 59 Series of 2001 – Rules and Regulation maintaining a clinical laboratory in which body fluids, tissues, Governing the Establishment, Operation and Maintenance of secretions, excretions and radioactivity from beings or animals are Clinical Laboratories in the Philippines analyzed for the determination of the presence of pathologic organisms, processes and/or the conditions in the persons or Section 1: Title animals from which they were obtained, shall register and secure a “Rules and Regulation Governing the Establishment, Operation and license annually at the office of the Secretary of Health: provided, Maintenance of Clinical Laboratories in the Philippines” that government hospital laboratories doing routine or minimum Section 2: Authority laboratory examinations shall be exempt from the provisions of this These rules and regulations are issued to implement R.A 4688; section if their services are extensions of government regional or Clinical Laboratory consistent with E.O. 102 s. 1999: Redirecting central laboratories. the Functions and Operations of the DOH. The DOH, through the SECTION 2. It shall be unlawful for any person to be professionally Bureau of Health Facilities and Services (BHFS) in the Health in-charge of a registered clinical laboratory unless he is a licensed Regulation Cluster, shall exercise the regulatory functions under physician duly qualified in laboratory medicine and authorized by these rules and regulations. the Secretary of Health, such authorization to be renewed annually. 3  MTPMLSP111 – PRINCIPLES OF MEDICAL LABORATORY SCIENCE LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA VERDE, E.J. | 1MT03 Section 3: Purpose o Leucocyte Number To protect and promote health of people by ensuring availability of Concentration (WBC Count) clinical laboratory that are PROPERLY MANAGED with adequate o Leucocyte Type Number resources, with effective and efficient performance through Fraction (Differential Count) compliance with quality standards. o Qualitative Platelet Determination Section 4: Scope Routine Urinalysis Routine Fecalysis 1. Regulations shall apply to all entities performing the activities Blood Typing – hospital-based and functions of clinical lab which shall include the Quantitative platelet determination examination and analysis of any or all samples of human and – hospital-based other related tissues, fluids, secretions, excretions, radioactive 2. Secondary Provides the minimum service of other materials form the human body for the determination capabilities of the primary of the existence of pathogenic organisms, pathologic category and the ff: processes/conditions in the person from whom such samples Routine Clinical Chemistry o Blood Glucose Substance are obtained. Concentration 2. Regulations DO NOT INCLUDE GOVERNMENT o Blood Urea Nitrogen LABORATORY during lab examinations limited to acid fast Concentration bacilli microscopy, malaria screening and cervical cancer o Blood Uric Acid Substance screening, provided their services are declared as extension of Concentration a licensed government clinical laboratory. o Blood Creatine Concentration Section 5: Classification of Laboratories o Blood Total Cholesterol Concentration BY FUNCTION Crossmatching 1. Clinical Hematology 3. Tertiary Provides the secondary service Pathology Clinical Chemistry capabilities and the following: Microbiology Special Chemistry Parasitology Special Hematology Mycology Immunology / Serology Clinical Microscopy Microbiology Immunology and Serology Immunohematology Blood Banking Section 6: Policies Lab Endocrinology Toxicology and Therapeutic Drug 1. An approved permit to construct and design lay-out of a Monitoring and clinical laboratory shall be secured from BHFS prior to Other similar disciplines submission of an application for a Petition to Operate. 2. Anatomic Serological Pathology 2. No clinical laboratory shall be constructed unless plans have Pathology Immunohistopathology been approved and construction permit issued by the BHFS. Cytology 3. A clinical laboratory shall operate with a valid license issued by Autopsy and Forensic Pathology BHFS/CHD, based on compliance with the minimum licensing BY INSTITUTIONAL CHARACTER requirements (annex A) 1. Hospital-Based Operates within the hospital 4. The clinical laboratory shall be organized and managed to 2. Non-Hospital- Operates on its own provide effective and efficient laboratory services. Based 5. The clinical laboratory shall provide adequate and appropriate BY SERVICE CAPABILITIES safety practices for its personnel and clientele. 1. Primary Routine Hematology (CBC) o Hemoglobin Mass Section 7: Requirements and Procedures for Application of Permit Concentration to Construct and License to Operate o Erythrocyte Volume Fraction 1. Application for Permit to Construct (Hematocrit) The following are the documents required: 4  MTPMLSP111 – PRINCIPLES OF MEDICAL LABORATORY SCIENCE LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA VERDE, E.J. | 1MT03 a. Letter of Application to the Director of BHFS the laboratory examinations are being performed for b. Four (4) sets of Site Development Plans and floor inspection. Plans approved by an architect and/or b. Each license shall make available to the Director of the engineer. BHFS/CHD or his duly authorized representative(s) all c. DTI/SEC Registration (for private clinical laboratory) pertinent records. 2. Application for New License c. Clinical laboratories shall be inspected every two (2) A duly notarized application form “Petition to Establish, years or as necessary. Operate, and Maintain a Clinical Laboratory” (Annex B), 7. Monitoring shall be filed by the owner or his duly authorized a. All clinical laboratories shall be monitored regularly and representative at the BHFS. records shall be made available to determine compliance 3. Application for Renewal of License with these rules and regulations. A duly notarized application form “Application for b. The Director of the BHFS/CHD or his authorized Renewal of License to Establish, Operate and Maintain a representative(s) shall be allowed to monitor the clinical clinical Laboratory” (Annex C), shall be filed by the owner laboratory at any given time. or his duly authorized representative at the respective c. All clinical laboratories shall make available to the CHD. Director of the BHFS or his duly authorized a. Renewal of License: representative(s) records for monitoring. Application for renewal of license shall be filled within 8. Issuance of License 90 days before the expiry date of the license The license shall be issued by the Director of the CHD or described as follows: his authorized representative, if the application is found to SCHEDULE OF APPLICATION FOR be meritorious. REGION RENEWAL OF LICENSE 9. Terms and Conditions of License NCR January to March a. The license is granted upon compliance with the 1, 2, 3, & CAR February to April licensing requirements. 4, 5, & 6 March to May b. The license is non-transferable. 7, 8, & 9 April to June c. The owner or authorized representative of any clinical 10, 11, 12, CARAGA & laboratory desiring to transfer a licensed clinical May to July ARMM laboratory to another location shall inform the CHD in writing at least 15 days before actual transfer. d. The laboratory in its new location shall be subject to re- 4. Permit and License Fees inspection and shall comply with the licensing a. A non-refundable license fee shall be charged for requirements. application for permit to construct, and for license to e. An extension laboratory shall have a separate license. operate a government and private clinical laboratory. f. Any change affecting the substantial conditions of the b. A non-refundable fee shall be charged for application for license to operate a laboratory shall be reported within 15 renewal of license to operate. days in writing by the person(s) concerned, to the c. All fees shall be paid to the cashier of the BHFS/CHD. BHFS/CHD for notation and approval. d. All fees shall follow the current prescribed schedules of Failure to do so will cause the revocation of the license of fees of the DOH. the clinical laboratory. 5. Penalties g. The clinical laboratory license must be placed in a a. A penalty of one thousand pesos (P1, 000.00) for late conspicuous location/area within the laboratory. renewal shall be charged in addition to the renewal fee for all categories if the application is filed during the next Section 8: Violations two (2) months after expiry date. b. An application received more than two (2) months after 1. The License to operate a clinical laboratory shall be suspended expiry date shall be fined one hundred pesos (P100.00) or revoked by the Secretary of Health upon violation of R.A. for each month thereafter in addition to the p1, 000.00 4688 or the Rules and Regulations issued in pursuance penalty. thereto. 6. Inspection 2. The following acts committed by the Owner, President, a. Each license shall make available to the Director of the Managers, Board of Trustees/Director, Pathologist or its BHFS/CHD or his duly authorized representative(s) at personnel are considered violations. any reasonable time, the premises and facilities where 5  MTPMLSP111 – PRINCIPLES OF MEDICAL LABORATORY SCIENCE LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA VERDE, E.J. | 1MT03 a. Operation of a clinical laboratory without a certified 2. No license shall be modified, suspended or revoked pathologist or without a registered medical unless prior notice has been made and the corresponding technologist. investigation conducted except in cases of willful, or b. Change of ownership, location, and head of repeated violations hereof, or where public health interest laboratory or personnel without informing the BHFS or safety requires otherwise. and/or the CHD. c. Refusal to allow inspection of the clinical laboratory Section 11: Repealing Cause by the person(s) authorized by the BHFS during These rules and regulation shall supersede ail other previous official reasonable hours issuances hereof. d. Gross negligence. e. Any act or omission detrimental to the public Section 12: Publication of List of Licensed Clinical Laboratories 3. The Provincial, City and Municipal Health Officers are authorized to report to the CHD and BHFS the existence of A list of licensed clinical laboratories shall be published annually in a unlicensed clinical laboratories or any private party performing newspaper of general circulation. laboratory examinations without proper license and/or Section 13: Effectivity violations to these rules & regulations. These rules and regulations shall take effect 15 days after its Section 9: Investigation of Charges or Complaints publication in the Official Gazette, or in a newspaper of general The BHFS/CHD or his duly authorized representative(s) shall circulation. investigate the complaint and verify if the laboratory concerned or any of its personnel is guilty of the charges. 8.3.3 ANNEX 1. If upon investigation, any person is found violating the provisions of R.A. 4688, or any of these rules and Technical Standards and Minimum Requirements regulations, the BHFS/CHD or his duly authorized representative(s) shall suspend, cancel or revoke for a The clinical laboratory shall be organized to provide determined period of time the license, as well as the effective and efficient laboratory services. authority of the offending person(S), without prejudice to taking the case to judicial authority for criminal action. I. Staffing 2. Any person who operates a clinical laboratory without the 1. The Clinical Laboratory shall be managed by a proper license from the Department of Health shall upon licensed physician certified by the Philippine Board conviction be subject to imprisonment for not less than 1 of Pathology. month but not more than 1 year or a fine of not less than In areas where pathologists are not available, a P1, 000.00 and not more than P5, 000.00 or both at the physician with a three (3) months training on clinical discretion of the court. Provided, however, that if the laboratory medicine, quality control and laboratory offender is a firm a corporation, the Managing Head management, may manage a primary/secondary and/or owner/s thereof shall be liable to the penalty category clinical laboratory. The BHFS shall certify imprisoned herein. such training. 3. Any clinical laboratory operating without a valid license or 2. The clinical laboratory shall employ qualified and whose license has been revoked/cancelled shall be adequately trained personnel. Work assignment shall summarily closed upon order issued by the BHFS.CHD or be consistent with the qualification of the concerned his duly authorized representative. The BHFS/CHD personnel. may seek the assistance of the law enforcement agency a. A clinical laboratory shall have sufficient to enforce the closure of any clinical laboratory. number of registered medical technologists proportional to the workload and shall be Section 10: Modification and Revocation of License available at all times during hours of laboratory operation. For the hospital-based clinical 1. A license maybe revoked, suspended or modified in full or laboratory, there shall be at least one registered in part for any materially false statement by the applicant, medical technologist per shift to cover the or as shown by the record of inspection or for a violation laboratory operation. of, or failure to comply any of the terms and conditions and provisions of these rules and regulations. 6  MTPMLSP111 – PRINCIPLES OF MEDICAL LABORATORY SCIENCE LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA VERDE, E.J. | 1MT03 3. There shall be staff development and appropriate 2. External Quality Control Program continuing education program available at all levels a. All clinical laboratories shall participate in an of organization to upgrade the knowledge, attitudes External Quality Assurance Program given by and skill of staff. designated National Reference Laboratory II. Physical Facilities and/or other recognized reference laboratories. 1. The clinical laboratory shall be well-ventilated, b. A satisfactory performance rating given by a adequately lighted, clean and safe. National Reference Laboratory shall be one of 2. The working space shall be sufficient to the criteria for the renewal of license. accommodate its activities and allow for smooth and c. Any refusal to participate in an External Quality coordinated work flow. Assurance Program given by the designated 3. There shall be an adequate water supply. National Reference Laboratories shall be one 4. The working space for all categories of clinical of the bases for suspension/revocation of the laboratories (both hospital and non-hospital-based) license of the laboratory shall have at least the following measurements: VII. Reporting Laboratory requests shall be constructed as consultation CATEGORY SPACE IN SQ. M between the requesting physician and the pathologist of Primary 10 the laboratory and as such laboratory results shall be Secondary 20 released accordingly: Tertiary 60 1. All laboratory reports on various examinations of specimens shall bear the name of the registered III. Equipment/Instruments medical technologist and the pathologist and duly 1. There shall be provisions for sufficient number and singed by both. types of appropriate equipment/instruments in order 2. No person in the clinical laboratory shall issue a to undertake all the activities and laboratory report, orally or in writing, whole or portions, thereof examinations. This equipment shall comply with without a directive from the pathologist or his safety requirements. authorized associate to the requesting physician or 2. For other laboratory examinations being performed, his authorized representative except in emergency the appropriate equipment necessary for performing cases when the results may be released as such procedures shall be made available authorized by the pathologist. IV. Glasswares/Reagents/Supplies VIII. Recording All categories of clinical laboratories shall provide There shall be a system of accurate recording to ensure adequate and appropriate glass wares, reagents and quality results. supplies necessary to undertake the required services. 1. There shall be an adequate and effective system of V. Waste Management recording requests and reports of all specimens There shall be provisions for adequate and efficient submitted and examined. disposal of waste following guidelines of the Department 2. There shall be provisions for filing, storage and of Health and the local government. accession of all reports. VI. Quality Control Program 3. All laboratory records shall be kept on file for at least All clinical laboratories shall have a functional Quality one (1) year. Assurance Program a. Records of anatomic and forensic pathology 1. Internal Quality Control Program shall be kept permanently in the laboratory a. There shall be a documented, continuous IX. Laboratory Fees competency assessment program for all The laboratory and professional fees to be charged for a laboratory personnel laboratory examination shall be at the prevailing rates. b. The program shall provide appropriate and 1. The rates shall be within the range of the usual fees standard laboratory methods, reagent and prevailing at the time and the particular place, taking supplies and equipment. into consideration the cost of testing and quality c. There shall be a program for the proper control of various laboratory procedures. maintenance and monitoring of all equipment. 2. Professional services rendered to the patient in the d. The program shall provide for the use of quality performance of special procedures or examinations control reference materials. shall be charged separately and not included in the 7  MTPMLSP111 – PRINCIPLES OF MEDICAL LABORATORY SCIENCE LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA VERDE, E.J. | 1MT03 laboratory fee/s. 8.4.2 MICROBIOLOGY 8.4 SECTIONS OF THE CLINICAL LABORATORY Microbiology Four sections: 8.4.1 CLINICAL CHEMISTRY o Bacteriology o Mycobacteriology o Mycology Clinical Chemistry o Virology Identification of bacteria and fungi on specimens received Intended for the testing of blood and other body fluids to Specimens: quantify soluble chemicals including waste products useful for o Blood the diagnosis of certain diseases o Body fluids o Blood and urine – most common body fluids o Stool subjected for analyses in this section o Tissues Examples of tests: o Swabs from diff sites in the body o Fasting blood sugar Tests: o Glycosylated hemoglobin (HbA1c) – diagnosis of o Microscopic visualization of microorganisms after diabetes staining, isolation, and identification of bacteria o Total cholesterol – high- and low-density (aerobes and anaerobes) and fungi using varied lipoproteins (HDL and LDL) culture media and different biochemical tests and at o Triglycerides (TAG) – diagnosis of cardiovascular times, antigen typing, and antibacterial susceptibility diseases testing o Blood uric acid (BUA) o Preparation of culture media and stains o Blood urea nitrogen (BUN) o Quality assurance and control o Creatinine – diagnosis of diseases in the kidney o Infection control o Total protein (TP) o Biosafety and proper waste disposal o Albumin Mycobacteriology – identification of mycobacterium o Electrolytes (sodium, potassium, chloride) o Clinical enzymology (aminotransferase, creatine kinase) 8.4.3 HEMATOLOGY AND COAGULATION STUDIES One of the busiest sections Characterized as a state-of-the-art, fully automated facility in majority of tertiary-level clinical laboratories Enumeration of cells in the blood and other body fluids (CSF, Endocrinology (in some labs) pleural fluid, etc.) o Blood and urine are also measured Examinations: Thyroid hormone tests: o Complete blood count o Thyroid-stimulating hormone (TSH) o Hemoglobin o T3 and T4 (triiodothyronine and thyroxine) o Hematocrit o Estrogen, prolactin, and testosterone o WBC differential count o Other labs: toxicology and drug testing sections o Red cell morphology and cell indices Internal Quality Assurance (IQA) & National External Quality o Quantitative platelet count Assurance Program (NEQAP) o Total cell count and differential count o Important activities that medtechs perform o Blood smear preparation o Staining for other body fluids Coagulation studies – focus on blood testing for the determination of various coagulation factors Automation of activities: o Bone marrow examination o Automated hematology analyzers 8  MTPMLSP111 – PRINCIPLES OF MEDICAL LABORATORY SCIENCE LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA VERDE, E.J. | 1MT03 8.4.4 CLINICAL MICROSCOPY Automated analyzers are commonly used Clinical Microscopy 8.5 ANATOMIC PATHOLOGY Two major areas: 1. Routine and other special examinations of urine 8.5.1 SECTION OF HISTOPATHOLOGY/CYTOLOGY o Macroscopic examinations ▪ Determine color, transparency, specific gravity, and pH level Histopathology / Cytology o Microscopic examinations Activities: ▪ Presence of abnormal cells and/or o Tissue processing parasites, quantify red cells and WBC o Cutting into sections and other chemicals found in urine o Staining o Examinations of other body fluids o Preparation for microscopic examination by a 2. Examination of stool or routine fecalysis pathologist o Detection and identification of parasitic worms and ova 8.6 SPECIALIZED SECTIONS OF THE LABORATORY 8.4.5 BLOOD BANK/IMMUNOHEMATOLOGY 8.6.1 IMMUNOHISTOCHEMISTRY Blood Bank / Immunohematology Immunohistochemistry Two main activities: o Blood typing Combines anatomical, clinical, and biochemical techniques o Compatibility testing where: Other activities: o Antibodies (monoclonal and polyclonal) are bounded o Screening for all antibodies to enzymes o Identification of antibodies and blood components o Fluorescent dyes – used to detect presence of for transfusion antigens in tissue Most critical section in the lab Useful in the diagnosis of some types of cancers by detecting Hospital-based: the presence of tumor-specific antigens, oncogenes, and o Blood donation activities: tumor suppressor genes ▪ Donor recruitment and screening Can also be used to assess the responses of patients to ▪ Bleeding of donor cancer therapy as well as diagnosis of certain ▪ Post-donation care neurodegenerative disorders 8.4.6 IMMUNOLOGY AND SEROLOGY 8.6.2 MOLECULAR BIOLOGY AND BIOTECHNOLOGY Immunology and Serology Molecular Biology and Biotechnology Activities: Using different enzymes and other reagents, DNA and RNA o Analyses of serum antibodies in certain infectious are identified and sequenced to detect any pathologic agents (primarily viral agents) conditions/disease processes Examples of antibody screening tests: Most common technique: o Hepatitis B profile tests o Polymerase chain reaction (PCR) o Serological tests for syphilis o Tests for Hepatitis C o Dengue fever 9  MTPMLSP111 – PRINCIPLES OF MEDICAL LABORATORY SCIENCE LECTURE | FIRST SEMESTER TRINITY UNIVERSITY OF ASIA VERDE, E.J. | 1MT03 8.7 LABORATORY TESTING CYCLE o Transcription errors Laboratory Testing Cycle 8.8 QUALITY ASSURANCE IN THE CLINICAL LABORATORY All activities starting from a medical doctor writing a laboratory request up to the time (turnaround time) the results are Quality Assurance generated and become useful information for the treatment and management of patients Encompasses all activities performed by laboratory personnel Three phases: to ensure reliability of test results 1. Pre-analytic Organized, systematic, well-planned, and regularly done with Receipt of the lab request the results properly documented and consistently reviewed Patient preparation Two major components: Specimen collection o Internal Quality Assurance System (IQAS) Proper transport and processing of specimen ▪ Day-to-day activities undertaken in order to the clinical lab to control factors or variables that may 2. Analytic affect test results Actual testing of the specimen ▪ Regular review and audit of results to Equipment and instruments used, reagents, identify weaknesses and consequently and internal quality control program perform corrective actions 3. Post-analytic o External Quality Assurance System (EQAS) Transmission of test results ▪ System for checking performance among Interpretation clinical labs Turnaround time ▪ Facilitated by designated external agencies Application of doctor’s recommendation ▪ National Reference Laboratories (NRL) – Diagnosis and treatment – based on the generated data DOH-designated EQAS Pre-Analytic Phase Designated NRL-EQAS: Variables that may affect test results: National Kidney and Transplant Institute (NKTI) – Hematology o Preparation of the request slip for the patient and Coagulation o Physiologic factors Research Institute of Tropical Medicine (RITM) – Microbiology o Diet (identification and antibiotic susceptibility testing) and o Medications Parasitology (identification of ova and quantitation of malaria) o Alcohol and caffeine intake Lung Center of the Philippines (LCP) – Clinical Chemistry (for o Exercise testing 10 analytes: glucose, creatinine, total protein, albumin, o Underlying disease conditions blood urea nitrogen, uric acid, cholesterol, sodium, potassium, o Identification of patients and labeling of specimens and chloride) o Anticoagulant used East Avenue Medical Center (EAMC) – Drugs of abuse o Volume of specimen collected vis-à-vis volume of (methamphetamine and cannabinoids) anticoagulant San Lazaro Hospital STD-AIDS Cooperative Center Laboratory (SACCL) – Infectious immunology hepatitis B Analytic Phase surface antigen (HBsAg), human immunodeficiency virus (HIV), hepatitis C virus (HCV) Variables: o Equipment and instruments o Quality of reagents used and internal quality control program Post-Analytic Phase Variables: o TAT 10