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TOPIC 1: INTRODUCTION TO MEDICAL TECHNOLOGY PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 __________________________________________________________________________________________ MODULE 1: WHAT IS MEDICAL TECHNOLOGY? * F A A clinical laboratory science related to the prevention, diagnosis, and treatment of disease. PDT MEDICAL LABORATORY SCIENTISTS? 4 numours- blood ] Detectives phlegm black pile, regimen , Perform routine and complex analyses Triad of HIPPOCRATES yellow pile. Responsible in the accuracy of results Correlate interdependent test results 460 B.C. Regarded as the founder of scientiﬁc medicine (father of Can supervise and teach medicine) He determined the correlation between anatomical and chemical laboratory ﬁndings and the causes of diseases THE EVOLUTION OF MEDICAL TECHNOLOGY PROFESSION AND He adopted the triad of regimen in treating diseases and EDUCATION infection with the use of drugs, surgery, and bloodletting DS B DEFINITION OF MEDICAL TECHNOLOGY intestinal parasites VIVIAN HERRICK HEINEMANN Application of principles of 1500 B.C. natural, physical, and biological Traces the beginning of Medical Technology when intestinal sciences to the performance of parasites such as Taenia (tapeworm) and Ascaris (intestinal applications laboratory procedures which aid parasite/roundworm; found in malnourished children) were in the diagnosis and treatment of mentioned in early writing diseases Ebers Papyrus - book containing the description of the three stages of hookworm infection ANNE FAGELSON The branch of medicine concerned with the performance Quacks , urinalysis RUTH WILLIAMS Medical performance of laboratory determinations and analyses used in the diagnosis 1096-1438 and treatment of diseases and She believed that Medical Technology began from the maintenance of health Medieval period, supported by the fact that urinalysis was a fad PHILIPPINE MEDICAL An auxillary branch of laboratory Early Hindu Doctors - made a scientiﬁc observation that the TECHNOLOGY ACT OF 1969 medicine which deals with the urine of certain individuals attracted ants and that such urine examination by various chemical, had a sweet taste 1 Diabetic microscopic, bacteriologic, and other medical procedures, technique which will aid the ANNE FAGELSON laboratory physician in the diagnosis, study medicine 14th century and treatment of disease and in the promotion of health in She preferred to date Medical Technology from the 14th general century Anatomists Alessandra Giliani - employed to perform tasks under the The law that governs the domain of Medical Technology by a prominent Italian profession physician at the University of Bologna but died from a laboratory acquired infection. died at 19 y O(septic infectionl. HISTORY OF MEDICAL TECHNOLOGY ANTON VAN LEEUWENHOEK 1632-1723 Animalcles-microorganism Father of microbiology He invented and improved the compound microscope H v RAM He was the ﬁrst to describe red blood cells, to see protozoan, and classify bacteria according to shape It led to the rapid progress of microbiology and pathology Morphology - study of shapes/classification of racteria · Round - cocci/coccus (bacteria in acuel ·Rod ball pac ana TOPIC 1: INTRODUCTION TO MEDICAL TECHNOLOGY PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 __________________________________________________________________________________________ - ather of pathology MALPIGHI 26TH MEDICAL INFANTRY OF THE US ARMY 1628-1694 Introduced Medical Technology practice in the Philippines at He was described as the greatest of the early microscopists the end of World War II His work in embryology and anatomy marked him as the They established the ﬁrst clinical laboratory in the Philippines founder of pathology (father of pathology) at Quiracada St., Sta. Crus, Manila where the Manila Public Health Laboratory is presently located quantitative test FEHLING They left the clinical laboratory in June 1943 and endorsed it to the National Department of Health 1848 - crystals , rbes , He performed the ﬁrst quantitative test for urine a cid protein , DR. PIO DE RODA 15TH CENTURY Realized the need for clinical laboratories in the Philippines. Aniline dyes, for staining microorganisms were produced He formally organized the Manila Public Health Laboratory about the middle 15th century from the remnants of the deserted laboratory. Hence, bacterial staining and microscopic study on bacteria He was assisted by Dr. Mariano Icasiano, who was then the were made possible Manila City Health Ofﬁcer, on October 1, 1945. In 1947, he revived the training of high school graduates to Pers I ESTABLISHMENT OF LABORATORIES work as medical technicians together with Dr. Prudencio Sta. Ana. No deﬁnite period and no certiﬁcates were given to the DR. DOUGLAS Established the ﬁrst chemical trainees. laboratory at the University of In 1954, a six-month laboratory training with certiﬁcate upon Michigan Michigan completion was given to the trainees. Dr. Sta. Ana prepared the syllabus. DR. WILLIAM WELCH Gave the ﬁrst laboratory course The two doctors were helped by Dr. Tirso Briones. in pathology. pathology Jonn Hopkins He became the ﬁrst professor of MEDICAL TECHNOLOGY EDUCATION IN THE PHILIPPINES pathology at John Hopkins University in 1885. MTE MRS. WILLA HILGERT HEDRICK DR. WILLIAM OSLER Opened the ﬁrst clinical laboratory at John Hopkins The founder of Medical Technology Education in the clinical lay Hospital in 1896. Jonn Hopkins Philippines "Malarial parasites" Search for malarial parasites in the blood were given special attention. DR. JESSE UMALI BSMT program Dis + The ﬁrst graduate of Philippines Union College, the ﬁrst DR. JAMES TODD Wrote the book “A Manual of Clinical Diagnosis” in 1908 and school to offer BS Medical Technology, now Adventist book "Manual of clinical was retitled “Clinical Diagnosis University of the Philippines diagnosis" by Laboratory Methods” by Dr. A successful OB-Gynecologist Todd and Dr. Standford SERIES OF EVENT WHAT HAPPENED NEXT? 1957-1958 Dr. Antonio Gabriel and Dr. Gustavo Reyes of World War I was an important factor in the growth of clinical the Faculty of Pharmacology, University of Sto. 1 year laboratory and produced a great demand for technicians Tomas offered MT as an elective to 4th and 5th MT as elective to University of Minnesota was the ﬁrst to offer degree level year students. Rev. Fr. Lorenzo Rodriguez pharmacy students program in 1923 decided to offer it as a course. 1931 - Denver Society of Clinical Pathologust was organized DSCP 1936 - American Board of Pathology was established * BP JUNE 17, 1957 A temporary permit was issued by the World War II - The use of blood increased and the closed Department of Education for the ﬁrst to third system of blood collection was widely used year students. JUNE 1960 Permit for the internship program was issued. HISTORY OF MEDICAL TECHNOLOGY IN THE PHILIPPINES JUNE 14, 1961 The full recognition of the 4-year BS Medical Technology course TOPIC 1: INTRODUCTION TO MEDICAL TECHNOLOGY PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 A + 1995t 75 % __________________________________________________________________________________________ MODULE 2: CAREER OPPORTUNITIES FOR THE CERTIFICATION AND LICENSING GRADUATE OF B.S. MEDICAL TECHNOLOGY Certiﬁcation examination created by PRC (Professional MEDICAL TECHNOLOGY EDUCATION Regulation Commission) A candidate must obtain a general average of at least 75% 4 yp BACHELOR OF SCIENCE IN MEDICAL TECHNOLOGY in the written test, with no rating lower than 50% in any of the major subjects, provided that the candidate has not failed a four-year degree program wherein the students attend in at least 60% of the subjects computed according to their classroom for three (3) years and does clinical rotations for relative weights one (1) year In the Philippines, Medical Technology graduates who will Clinical Internship program: 40hrs per week for 52 weeks (or pass the Philippines Board of Medical Technology are entitled one full year) to use RMT (Registered Medical Technologist) after their Teach on how to collect, preserve and analyze specimens name, their relative weights such as blood, urine, cells and tissues as well as the *Please see RA 5527 for more information preparation of reagents and stains Train on how to use modern equipment, instruments and OTHER CERTIFYING AGENCIES scientiﬁc methods to provide accurate laboratory results American Medical Technologist in Rosemont, Illinois AHP(B National Healthcare Association National Phlebotomy Association 1yr IN CALIFORNIA National Center for Competency Testing Accrediting Bureau of Health Education Schools One-year degree and students are required to take courses in clinical chemistry, transfusion services, phlebotomy, medical microbiology, hematology and coagulation QUALIFICATION FOR EXAMINATION Graduates are prepared to take California State Licensing Examination and certiﬁcation examination through American 1. Good Moral Character Society of Clinical Pathology 2. Good Health 3. Has completed a course of at least four years leading to the degree of Bachelor of Science in Medical Technology by a 2yr IN UNITED STATES recognized school, college or university Two-year qualiﬁes the graduate to work as a medical laboratory technician (MLT). SCOPE AND EXAMINATION Medical Technologist is trained much more extensively in the theory of the various MT disciplines. 1. Clinical Chemistry (20%) 2. Hematology (20%) 3. Immunology and Serology/Blood Banking (20%) 37r IN CANADA 4. Microbiology [Bacteriology, Parasitology and Mycology and Virology] (20%) Three-year college programs are offered that include seven 5. Urinalysis and other Boody Fluids (10%) semesters, in which two comprised an unpaid internship 6. Histopathology, MT Laws and Bioethics (10%) The student graduates before taking a standard examination (such as the Canadian Society for Medical Laboratory Science, or CSMLS exam) to be qualiﬁed as a medical laboratory 4 PROFESSIONAL ORGANIZATIONS technologist PAMET 1. Philippine Association of Medical Technologist (PAMET) PASMETH2. Philippine Association of Schools of Medical Technology and 8 MEDICAL TECHNOLOGY EDUCATION CHMPIBCH Public Health (PASMETH) 3. Local Professional Associations: PFPA Philippine Federation of Professional Associations CHA Council of Health Agencies PCQACL Philippine Council for Quality Assurance in Clinical Laboratories 4. International Professional Associations: International Federation of Biomedical Laboratory IF BLC Scientists A PF(B Asia-Paciﬁc Federation of Clinical Biochemistry TOPIC 1: INTRODUCTION TO MEDICAL TECHNOLOGY PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 __________________________________________________________________________________________ CAREER OPPORTUNITIES SPECIFIC PROFESSIONS/CAREERS/OCCUPATIONS FOR GRADUATES Licensed Medical Technologists/Medical Laboratory Scientists Diagnostic Molecular Scientists FIDREDPH Research Scientists Educators Diagnostic Product Specialists Public Health Practitioners Healthcare Leaders AN MT/MLS GRADUATE MAY PRACTICE IN THE FOLLOWING FIELDS: Public Health/Epidemiology Veterinary Laboratory Science = PUMNFHF Molecular Biology/Biology Nuclear Science Forensic Science Health Administration/Management Food and Industrial Microbiology *as per CMO 13 series of 2017 CAREER OPPORTUNITIES ABROAD There is a steady demand for Medical Technologist overseas Requires one to take their licensure examination as well as required trainings. Requires to have an experience of 2 years or more. SALARY LEVELS ❖ IN THE PHILIPPINES ➔ Registered Medical Technologist with 1 to 4 years of experience receive a monthly salary ranging from P10, 000 to P20, 000 per month. ❖ ABROAD ➔ In industrialized countries, pay is deﬁnitely higher than local rates. Salary in the USA ranges from $50, 000 to $70, 000 per year. QUESTIONS: 1. A BSMT graduate may practice in the ﬁeld of molecular biology ➔ TRUE 2. The National Organization of All Recognized Schools of Medical Technology in the Philippines is PAMET > - Philippine Association of Medical Technologist (passed the board exams) ➔ FALSE - PASMETH > - Philippine Association of schools of MT and Public Health 3. Medical professionals who draw blood from patients for various lab tests and procedures are called phlebotomists ➔ TRUE TOPIC 2: THE CLINICAL LABORATORY PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 __________________________________________________________________________________________ Institutional CLINICAL LABORATORY If According to Instructional Characteristics - A clinical laboratory isa place where specimens from the INSTITUTION-BASED human body may be collected, processed, examined or analyzed operates within the premises of an institution such as: Its main task is to provide accurate information to doctors for bastainstitution ★ Hospital diagnosis, prognosis and treatment of disease daghan depts ! ★ School Actively involved in research, infection control, information ★ Medical Clinic ★ Medical facility for overseas workers and seafarers evaluation and innovative diagnostic technologies. ★ Birthing home ★ Psychiatric facility ★ Drug Rehabilitation center PURPOSE OF LABORATORY Hospital-based laboratory is the most common example Provide physicians and health care professionals with information to: ★ detect disease or predisposition to disease FREE-STANDING ★ conﬁrm or reject a diagnosis DCEG M not part of an established institution ★ establish prognosis Free-standing Out-patient Clinical laboratory is the most ★ guide patient management common example ★ monitor efﬁcacy of therapy ❖ QUICK QUESTION: GP According to Ownership Who plays a very signiﬁcant role in the performance of laboratory setting and ensuring the reliability of test results? GOVERNMENT-OWNED - Medical Technologist/ Clinical Laboratory owned wholly or partially, by national or local government Scientist units ★ Clinical and anatomical laboratories of DOH-run government hospitals 4710sCLASSIFICATION OF CLINICAL LABORATORY 35V San Lazaro Hospital Jose R. Reyes Memorial Medical Center University of the Philippines-Philippine According to Funciton CA General Hospital ★ Local government-run hospital-based clinical p lood and other body fluids CLINICAL PATHOLOGY laboratories Ospital ng Maynila Medical Center OS B focuses on the areas of: All lab sections except Sta. Ana Hospital ★ Clinical Chemistry # IS TO PATHOLOGY ! Bulacan Medical Center ★ Blood banking ★ Microbiology ★ Immunology and Serology ★ Hematology PRIVATELY-OWNED ★ Serology ★ Parasitology owned, established, and operated by an individual, ★ Clinical Microscopy corporation, institution, association, or organization ★ St. Luke’s Medical Center ★ Toxicology SMM ★ Makati Medical Center ★ Therapeutic drug monitoring ★ Endocrinology ★ MCU-FDTMF Hospital concerned with the diagnosis and treatment of disease through laboratory testing of blood and other body ﬂuids According to Service Capability MicrOSCOPIC ANATOMIC PATHOLOGY 10392m. PRIMARY CATEGORY focuses on the areas of: UHICASF Traditional Laboratory ★ Histopathology licensed to perform basic, routine laboratory testing such as ★ Immunohistopathology ★ Routine Urinalysis > Urine - ★ Cytology UFH ★ Routine Fecalysis > Stool - ★ Autopsy ★ Surgical Pathology G ★ Routine Hematology >blood - Complete Blood Count ★ Forensic Pathology concerned with the diagnosis and treatment of disease it Y HHWRDP 1. Hemoglobin 2. Hematocrit through microscopic examination of tissues and organs 3. WBC count TOPIC 2: THE CLINICAL LABORATORY PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 __________________________________________________________________________________________ 4. RBC count Equipment requirements include those seen in secondary 5. WBC differential count laboratories along with 6. Qualitative platelet count 1. Automated Chemistry Analyzer Blood Typing 2. Biosafety cabinet class II Gram Staining (if hospital-based) 3. Serofuge Equipment requirements are but not limited to Space requirement is at least 60 square meters 1. Microscopes 2. Centrifuge NRL NATIONAL REFERNCE LABORATORY 3. HCT centrifuge Space requirement is at least 10 square meters A laboratory in a government hospital designated by the DOH to provide special diagnostic functions and services for certain diseases X clinical 20 sa'm SECONDARY CATEGORY memistry Functions include ★ referral services Conventional/Semi-automated Laboratory ★ provision of conﬁrmatory testing licensed to perform tests done by PRIMARY LABORATORIES ★ Assistance for research activities along with ★ Implementation of External Quality Assurance ★ Clinical Chemistry Programs (EQAP) Blood Glucose Concentration ★ Resolution of conﬂicts regarding test results of Blood Urea Nitrogen different laboratories Blood Uric Acid ★ Training of Medical Technologists on certain Blood Creatinine specialized procedures Cholesterol Determination Total protein Mass Concentration ❖ National Reference Laboratory is considered as a Tertiary ★ Microbiology (if Hospital-based) Laboratory Gram Stain SENPLR KOH Mount (yeaSt) U NATIONAL REFERENCE LABORATORIES IN THE PHILIPPINES ★ Blood bank Crossmatching HIV San Lazaro Hospital (SACCL) HIV and other STDs Minimum equipment requirements are but not limited to 1. Microscopes East Avenue Medical Center For Environment and toxicology EAM( occupational health toxicology 2. Centrifuge MCHS AlO 3. Hematocrit centrifuge and micronutrient assay 4. Semi-automated analyzers 5. Autoclave National Kidney and Transplant Hematology Inc. 6. Incubator NkT Immunohematology and 7. Oven Immunopathology and Anatomic Space requirement is at least 20 square meters Pathology Philippine Heart Center Pathology for Cardiac Disease no salm TERTIARY CATEGORY Lung cancer of the Philippine Atomic pathology for pulmonary Sophisticated/Automated Laboratory disease licensed to perform all the laboratory tests done by SECONDARY LABORATORY along with Research Institute for Tropical Dengue, Inﬂuenza, TB, and other 5 ISHI ★ Immunology and Serology Medicine Mycobacteria, Malaria and other NS1-Ag for Dengue viral exanthems, Mycology, ★ Microbiology, Bacteriology and Mycology Enteroviruses, Antimicrobial Differential staining resistance and engineering Culture and Identiﬁcation of bacteria and disease fungi Antimicrobial Susceptibility testing ★ Special Clinical Chemistry Clinical Enzymology Therapeutic drug monitoring Markers for certain diseases ★ Special Hematology Bone marrow studies Special staining for abnormal blood cells Red cell morphology ★ Immunohematology and Blood Banking Blood donation program Antibody screening Identiﬁcation and Preparation of blood components TOPIC 2: THE CLINICAL LABORATORY PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 __________________________________________________________________________________________ QUICK QUESTION: Classify SWU-Medical Center Clinical Laboratory according to: a. Institutional Characteristics b. Ownership c. Service Capability - SWU-MC laboratory is an institutional-based, privately-owned tertiary hospital. SUMMARY CLASSIFICATIONS OF CLINICAL LABORATORY ACCORDING TO FUCNTION CLINICAL PATHOLOGY > - blood and other body finids (all except histopath) ANATOMICAL PATHOLOGY > - microscopic of organs' tissue ACCORDING TO INSTITUTION-BASED > - hospital-based INSTITUTIONAL CHARACTERISTICS FREE-STANDING > - outpatient clinical lab ACCORDING TO OWNERSHIP GOVERNMENT-OWNED > - owned by gov , bott or local you PRIVATELY-OWNED > - owned by individual ACCORDING TO SERVICE PRIMARY CAPABILITY CATEGORY/LABORATORY > - basic urine blood , stool , 10sa'm SECONDARY CATEGORY/LABORATORY > - clinical memistry 20 sq2m TERTIARY CATEGORY/LABORATORY >! - 40sa'm (Sosyal) NATIONAL REFERENCE LABORATORY (can be - a : SENLPR considered as Tertiary Laboratory) san Lazaro Hospital East Avenue Medical Center National Kidney and transplant Lung cancer of the philippines philippine heart center Institute forTropical Research Medicine TOPIC 2: THE CLINICAL LABORATORY PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 __________________________________________________________________________________________ LAWS OF THE OPERATION, MAINTENANCE, AND SECTION 9: Investigation of Charges or Complaints REGISTRATION OF CLINICAL LABORATORIES IN THE Any person found violating the provisions of RA 4688, shall PHILIPPINES ↑ month suspend, cancel or revoke for a determined period of time the. 1yr license, as well as authority of the offending person/s. REPUBLIC ACT NO. 4688: Clinical Laboratory Act of 1966 Any person who operates a clinical laboratory without proper ADMINISTRATIVE ORDER NO. 59 s. 2001 1k - 5k license from DOH shall upon conviction be subject to imprisonment for not less than 1 month but not more than 1 year OR a ﬁne of no less than P1000 and not more than REPUBLIC ACT NO. 4688: CLINICAL LABORATORY ACT OF 1966 P5000 or both at the discretion of the court Act regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the department of health, providing penalty for the violation TECHNICAL STANDARDS AND MINIMUM REQUIREMENTS thereof, and for other purposes. PURPOSE: ➔ To protect and promote the health of the people by STAFFING ensuring availability of clinical laboratories that are properly managed with adequate resources, with effective and efﬁcient performance through HEAD compliance with quality standards Approved on June 18, 1966 Managed by a licensed physician certiﬁed by the Philippine Board of Pathology If Pathologists are not available, a Physician with 3 months ADMINISTRATIVE ORDER NO. 59s. 2001 training on Clinical Laboratory Medicine, Quality Control and Laboratory Management may manage a PRIMARY and “Rules and Regulations Governing the Establishment, SECONDARY laboratory Operation and Maintenance of Clinical Laboratories in the Philippines” QUICK QUESTION: Created to implement R.A. 4688 A Certiﬁed Pathologist may be authorized to manage or supervise in not more than ___ Clinical laboratories/Blood banks. - 4 laboratories/blood banks SECTION 7: Requirements and Procedures for Application of Permit to Construct and License to Operate PERSONNEL Application for permit to construct * BUTAYO es 1. Letter of Application to the BHFS Director Shall have sufﬁcient number of Medical Technologies 2. Four sets of Site Development Plans and Floor proportional to the workload and be available at all times Plans approved by an architect and/or engineer during hours of operation. 3. DTI/SEC Registration (for private clinical laboratory) In hospital-based laboratory, there shall be at least (1) Application for new license Medical Technologist per shift to cover the operation. 1. Duly notarized form “Petition to Establish, Operate, and Maintain a Clinical Laboratory” ﬁled at the BHFS PHYSICAL FACILITIES Application for renewal of license 1. Duly notarized form “Application for Renewal for 1. Itshould be well-ventilated, adequately lighted, safe and License to Establish, Operate and Maintain a clean Clinical Laboratory” ﬁlled at respective CHD 2. The space shall accommodate its activities and allow for 2. Shall be ﬁlled 90 days before the expiry of license smooth workﬂow. 3. The place to work in shall have an adequate water supply 4. Shall have the following measurements: SECTION 8: Violations Operation of a laboratory without a certiﬁed pathologist or CATEGORY Space in sq. m without a registered medical technologist Change of ownership, location, head of laboratory without Primary 10 informing the BHFS and/or CHD Refusal to allow inspection of laboratory Secondary 20 Gross negligence and any act or omission detrimental to the public Tertiary 60 TOPIC 2: THE CLINICAL LABORATORY PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 CMAMBIH & __________________________________________________________________________________________ EQUIPMENT/INSTRUMENT (t) SECTIONS OF THE CLINICAL LABORATORY urine PRIMARY SECONDARY TERTIARY /bloods CLINICAL CHEMISTRY Testing blood and other body ﬂuids to quantify essential Clinical centrifuge All those in 1 plus All those in 2 plus coagulated the following: the following: soluble chemicals such as waste products Urine and Blood are the 2 most common ﬂuids Hemacytometer Refrigerator Incubator One of the busiest sections, state-of-the-art, fully automated facility Microhematocrit Photometer or Balance Examples of tests performed: centrifuge equivalent 1. Fasting Blood Sugars (FBS) 2. Glycosylated Hemoglobin (HbA1c) - diagnosis of Microscope with oil Waterbath or Rotator diabetes equivalent = heart 3. HDL (good lipid) and LDL(bad lipid) ↑ IDL disease 4. Triglycerides (TAG) - diagnosis of cardiovascular Hemoglobinometer Timer or equivalent Serofuge or diseases or equivalent equivalent 5. Uric Acid (BUA) 6. Blood Urea Nitrogen (BUN) Differential counter Autoclave 7. Creatinine or equivalent 8. Total Protein (TP) Drying oven bacteria and fungi MICROBIOLOGY Biosafety cabinet Subdivided into four sections: (BSC) or equivalent 1. Bacteriology - culture (c/s), gram staining (g/s), KOH 2. Mycobacteriology - fungal sensitivity anad culture QC QUALITY CONTROL PROGRAM 3. Mycology - fungi identiﬁcation only 4. Virology - virus identiﬁcation Identidiﬁcation of bacteria and fungi on specimens received INTERNAL QUALITY CONTROL PROGRAM (usually blood and other ﬂuids, stool, tissues, and swabs from different sites in the body) There shall be a documented, continuous competency assessment program for all laboratory personnel The program shall provide appropriate and standard blood HEMATOLOGY laboratory methods, reagents and equipment There shall be a program for the proper maintenance and Enumeration of cells in the blood and other body ﬂuids (e.g., monitoring of all equipment CSF, pleural ﬂuid, etc.) The program shall provide for the use of quality control Examinations done: reference materials 1. CBC > complete blood round Maintenance - 2. Hemoglobin 3. Hematocrit 4. WBC differential count EXTERNAL QUALITY CONTROL PROGRAM 5. Red cell morphology and cell indices 6. Quantitative platelet count All laboratories shall participate in an External Quality 7. Total cell count and differential count Assurance Program given by National Reference Laboratories 8. Blood smear preparation and other reference laboratories 9. Staining for other ﬂuids 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 TOPIC 2: THE CLINICAL LABORATORY PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 __________________________________________________________________________________________ urine's Stool Useful in diagnosis of some types of cancers and certain CLINICAL MICROSCOPY neurodegenerative disorders, and assessment of patients’ responses to cancer therapy Two major areas: 1. Routine and special examinaton of urine 2. Examination of stool (routine fecalysis) 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: What section is considered as the most critical in the clinical laboratory (faulty cross-matching may cause patient’s death? - Blood Bank cross-matching Y LABORATORY TESTING CYCLE D100dv BLOOD BANK Encompasses all activities starting from a medical doctor writing a laboratory request up to the time (turn-around time Also called as Immunohematology Most critical section (need to have presence of mind) [TAT]) the results are generated for treatment and Blood typing and compatibility testing are the two main management of patients. activities Medical technologists should have a clear understanding of Other tests performed: the testing cycle to prevent erroneous test results 1. Antibodies screening and identiﬁcation, blood Has three phases: Pre-analytic, analytic, and post-analytic components for transfusion Turn-around time is the amount of time it takes to complete a 2. If hospital-based laboratories: - donor recruitment and screening bleeding process. (From doctor to releasing of results) of donor, post-donation care antibodies IMMUNOLOGY AND SEROLOGY Analyses of serum antibodies in certain infectious agents (primarily viral agents) Antigens and antibodies testing serology-study of blood serum Antibody screening tests: 1. Hepatitis B proﬁle tests 2. Serological tests for syphilis 3. Hepatitis C tests 4. Dengue fever HISTOPATHOLOGY ANATOMICAL PATHOLOGY: Histopathology and Cytology Tissue processing Cutting into sections allprocessor onowsuave ande Staining Preparation of microscopic examination by the pathologist 2 PRE-ANALYTICAL ANALYTICAL POST-ANALYTICAL PHASE PHASE PHASE SPECIALIZED SECTIONS: 1. Laboratory Test 1. Equipment and 1. Data Immunochemistry Order/Requisition instruments Transmission/ 2. Order Requisition 2. Quality or Interpretation Combines anatomical, clinical, and biochemical techniques 3. Patient reagents used 2. Results where antibodies (monoclonal and polyclonal) bounded to Preparation 3. Internal quality Application enzymes and dyes are used to detect presence of antigens in 4. Specimen control 3. Turn-Around Time tissue transport and (TAT) Proccessing check up specimenincab results of specimen TOPIC 2: THE CLINICAL LABORATORY PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 __________________________________________________________________________________________ QUICK QUESTION: 11) The picture shown below is a test done in what section of Identify if the error is Pre-Analytical, Analytical or Post-analytical phase clinical laboratory error urine +est a.Incorrect patient Identiﬁcation & Before collection Pre-analytic : ( b.Incomplete lab results ↑ After specimen identi : Post Analytic urine and testing Analytic ya c. Instrument malfunction 5 During lap : + 0013 - a. Pre-analytical a. Hematology - blood c. Clinical Chemistry b. Post-analytical b. Clinical Microscopy d. Blood Bank J blood c. Analytical 12) Anatomic Pathology is concerned with the diagnosis and - treatment of disease through laboratory testing microscope organs a. TRUE b. FALSE KAHOOT 13) Classiﬁcation of Clinical Laboratory 1) All of the following are performed in Secondary Category a. Function, Institutional Characteristic, Ownership, Service Laboratory EXCEPT Capability a. Routine urinalysis - c. Blood Glucose Determination ↑ b. Function, Characteristics, Leadership, Service Capability b. Blood Urea Nitrogen ~ d. NS1-Ag for Dengue certiary) c. Ethics, Characteristics, Ownership, Service Capability 2) Hi-Precision Diagnostics is an example of? 14) National Reference Laboratory for Cardiac Disease a. Hospital based laboratory mostly out patients. a. Philippine Heart Center I b. Free standing laboratory b. National Kidney and Transplant Institute >- nematology c. Medical clinic based laboratory (Free-standing) c. Lung Cancer of the Philippiens T pulmonary d. School based laboratory d. San Lazaro Hospital > - SDI , HIV 3) A clinical laboratory category that is owned wholly or 15) Areas of Clinical Chemistry, Blood Banking, Microbiology, partially, by national or local government units Serology blood and other fluids a. Institution-based a. Anatomic Pathology I b. Clinical Pathology ownership private : or Government b. Privately-owned Institutional : Institution 16) Clinical Pathology is concerned with diagnosis and treatment or free standing c. free-standing of diseases through microscopic examination > - Anatomic d. Government-owned a. TRUE b. FALSE Pathology 4) A primary category laboratory performs blood typing 17) Section 8 of Administration order No. 59 s 2001 a. TRUE ROUTINE : a. Investigation of Charges or Complaints section a · Urinalysis nematology /(BC) : b. FALSE fe(alysis · b. Requirements section # 5) The space requirement of Tertiary Laboratory is at least: c. Violations a. 10 sq. m c. 60 sq. m d. Procedures for application section b. 20 cm d. 60 cm 18) Most common example of Institution-Based Laboratory O 6) Equipment in Primary Laboratory, except: a. School-based c. Hospital-based a. Microscope c. hemoglobinometer b. Out-patient d. Free-standing lout-patient labs) b. Hemacytometer d. rotator stertiary 19) Incorrect specimen collection is an error of what phase in 7) Who plays a very signiﬁcant role in the performance of laboratory testing cycle? laboratory setting and ensuring the reliability of test results? a. Pre-Analytical c. Analytical a. Nurse c. doctor accuracy of results b. Post-Analytical d. Diagnostic b. Medical Technologist d. Physical therapist 20) CBC Testing is under? 8) The Head of a Laboratory should be a a. Primary Category c. Secondary Category a. Licensed physicians certiﬁed by the Philippine Board of b. Tertiary Category d. All of the above Pathology if no physician pathologist with , 21) In hospital-based laboratory, there shall be at least (1) b. Medical Technogist - months training Medical Technologist c. Chief Medical Technologist a. TRUE b. FALSE d. Chief Nurse 22) The doctor ordered the following: Lipid proﬁle, AST, ALT, 9) The National Reference Laboratory for HIV and other STDs ACP. Which section in the laboratory are these tests done? a. San Lazaro Hospital a. Hematology c. Clinical Microscopy b. National Kidney and Transplant Institute > - anatomic pathology b. Clinical Chemistry d. Blood bank c. East Avenue Medical Center > - to xiology 23) How many laboratories/blood banks should a certiﬁes d. Philippine Heart Center > - cardial pathologist may be authorized to manage or supervised? 10) A place where specimens from the human body may be a. 1 c. 4 collected, processed, examined or analyzed b. 5 d. 8 a. Nurse station c. Clinical Laboratory 24) Laboratories should be well-ventilated, adequately lighted, b. Patient rooms d. Doctor’s Clinic safe and clean a. TRUE b. FALSE TOPIC 2: THE CLINICAL LABORATORY PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 __________________________________________________________________________________________ 25) The space requirement of a Secondary Laboratory is at least 15 sq. m 2039. M a. TRUE b. FALSE 26) Turn-Around Time > amount - it takes to complete a process a. Pre-analytical c. Analytical b. Post-analytical 27) Specimen Collection a. Pre-analytical c. Analytical b. Post-analytica; 28) Rotator is used in a Secondary Laboratory - > tertiary laboratory a. TRUE b. FALSE 29) The space requirement of a Primary Laboratory is at least: a. 60 sq. m Itertiary c. 20 sq. m /secondary b. 15 sq. m d. 10 sq. m 30) Routine fecalysis a. Clinical Chemistry c. Blood Banking b. Clinical Microscopy d. Microbiology TOPIC 3: THE CONTEXT OF LABORATORY MANAGEMENT PMLS 037 | PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 __________________________________________________________________________________________ MANAGEMENT Successful Leadership Principles “The implementation of processes necessary to keep an LEADERSHIP memorize ! organization functioning properly.” 1. Listening 2. Enthusiasm 3. Awareness 5 MANAGEMENT PROCESSES POSD( 4. Decisive 5. Equal identify goals PLANNING 6. Reward 7. Shallow Mission/Vision Identifying goals and determining the best course of action 8. Hypocrite required to achieve those goals 9. Isolate 10. Positive Communication ★ What do you want to do? ★ Why are you doing it? ★ Who is involved doing it? ★ How and when? Effective Management ★ How much is the cost? Time ★ What is likely to go wrong? TFH ★ How will you know if you met your goals? Human Financial responsibilities ORGANIZING Level of Management Assigning responsibilities to the employees with detailed skillsets needed to complete the task Top TML Middle ★ How do your prioritize your work? Lower ★ What are some organizational methods you feel are effective? ★ How do you ensure you meet important deadlines? ★ What organizational skills or tools do you use? Focus on Patient selecting STAFFING The patient is an important part of a laboratory. They need to be approached in the best way possible Hiring the right people, for the right positions to help the organization achieve its objectives Focus on Staff ★ How do you source top employees? ★ What does a typical hiring timeline look like? It is the workface that ensures feasibility of processes and ★ What guarantees do you offer to employees? obtaining reliable results. ★ How do you support employees? ★ How to ensure strong retention? The competency of staff is vey important lead DIRECTING MODULE 4 Leading people what to do and seeing that they do it to the best of their ability LABORATORY ORGANIZATION & LABORATORY MANAGEMENT LEADERSHIP AND MANAGEMENT monitor CONTROLLING Monitoring employees performance, comparing it with the Management Leadership goals, and taking corrective actions as needed. Old French word Provides the direction of ménagemnet - “the art of where one (or an BASIC CHARACTERISTICS REQUIRED TO OPERATE A CLINICAL conducting, directing” organization) is going LABORATORY Latin from manu agree - Four key leadership styles: “to lead by the hand” supporting, directing, Successful Leadership SEARPS Leading and directing all or delegating, and coaching Effective Management part of an organization Engage others to complete Accuracy and Reliability through the use of human, tasks in a timely and Focus on patient ﬁnancial and intellectual productive manner. Focus on staff resources. Provides the “the road to SDDC Organization chart should be drawn with the responsibilities get there” at all levels clearly deﬁned MANAGEMENT Characterizes the process of leading and directing all or part of an organization, through the use of human, ﬁnancial and intellectual resources. The adage illustrates why leadership must be visionary and must set clear goals with strategic objectives. Requires an optimal mix of skilled personnel, dedicated people, and task-oriented leaders to achieve these goals. , Dedication Task-oriented skills , Four Primary Management Functions 1. Planning PPOLL 2. Prompt 3. Organizing 4. Leading and controlling QUALITY SYSTEMS MANAGEMENT LEADERSHIP A series of processes in motion set by measurements that will Provides the direction of where one (or an organization) is ensure the quality of the laboratory. going. Consist of 5 Pillars A pattern of behaviors used to engage others to complete tasks in a timely and productive manner. Supportive Leader provides physical and personal resources 5 Pillars of Quality Systems Management so that an individual can accomplish his or her duties. Directive Leader presents rules, orders, or other deﬁned instructions to the individual. Memorize : PPWRC V S. Quality Policies A statement of the goals of the organization with respect to its Quality System statement Management Quality Procedures The details of the QSM, including the speciﬁc processes, procedures and staff details PPS responsibilities ISO STANDARDS Work Instructions The actual instructions for performing tasks that affect the quality standards of the The gold standard for medical laboratory, in particular, is ISO actual organization 15189:2007 instructions ISO 15189:2007 deﬁnes the particular requirements for Quality Records Documents that demonstrate conformance to quality management systems requirements speciﬁc to documents the speciﬁed requirements medical laboratories. Corrective Action Controlled documents that specify how Requests problems with the organization’s QSM are to ORGANIZATION STRUCTURE controlled does be ﬁxed. To avoid assumptions… Organization chart should be drawn with the responsibilities at all levels clearly deﬁned Assigned of responsibility The management team is responsible for strategic planning and it should be based on the vison and goals set. LABORATORY ORGANIZATION CHART To avoid assumptions… Totalqui / Staff Qualiﬁcations ~ Laboratory management shall ensure that there are appropriate numbers of staff, with the required education and training, to meet the demands of the service and appropriate national legislation and regulations. Registration of staff shall be in accordance with current national legislation and regulations The stafﬁng shall include an individual(s) with the following roles: a) Quality management QTH b) Training and education c) Health and Safety S Personal Management PERSONAL AND STAFF Personnel management ensures that staff contribute fully and effectively to the service while receiving fair and consistent treatment from laboratory management. U Process of Planning Laboratory management shall ensure that procedure(s) for personnel management include: a) Staff recruitment and selection Time Management Turnaround time of reports b) Staff description and induction c) Job descriptions and contracts Who is going to do roles should be deﬁned and responsibilities d) Staff records what spelt out e) Staff annual joint review f) Staff meetings and communication Use of human the management needs to ensure adequate g) Staff training and education resources stafﬁng h) Grievance procedures and staff disciplinary action Management so that all processes are supervised and worklﬂow monitored for quality performance U Job Description and Contracts Financial Resources Written job descriptions and contracts enable staff to know their duties, responsibilities and rights Set benchmarmarks the team should have a goal set that would All staff shall have contracts of employment which are in or standards achieve the necessary standards. No compliance compromises on quality will be allowed and Laboratory management shall ensure that all staff have job benchmarking should be against the descriptions that include: internationally accepted standards. a) A job title JLAPDP b) The location within the organization c) Accountability Stafﬁng d) The main purpose of the job e) The main duties and responsibilities The staff are the single most important asset in any f) A requirement for participation in staff annual joint laboratory review The laboratory shall be directed by a person or persons who have executive accountability and the competence to assume Staff Records responsibility for the services provided. Maintenance of accurate staff records is an essential part of Speciﬁc Duties: Director personnel management Laboratory management shall ensure the conﬁdentiality of Staff operates according to the regulatory environment staff record in accordance with local guidelines and national Staff are adequate in number, competent, trained legislation appropriately and evaluated Staff operate in a safe environment Staff Training Methods and instruments are validated and veriﬁed Laboratory conforms to all internal quality procedures and Records shall be kept of all training and education enrolled in EQA program Laboratory management shall appoint a training ofﬁcer There shall be resources for training and education, that Primary Responsibilities of Director includes: J a) Access to reference material and information Interaction with users of laboratory services Quality issues b) Access to a conveniently situated quiet for private Future planning IQFER 4 study Education c) Staff attendance at meetings and conferences Research d) Financial support RCSF CONTROL OF CLINICAL MATERIAL Notice shall be taken of current legislation, regulations and guidelines. Laboratory management shall establish a procedure(s) for controlling material that includes: a) Identiﬁcation and indexing ISRSD T b) Security Y c) Retention d) Storage and retrieval e) Disposal Equipment - Criteria for Selection PREMISES AND ENVIRONMENT Need analysis Performance characteristics Management will be responsible for providing space ensuring Size and space availability client comfort and safety of clients and employees, without Costs compromising on the quality of the service provided Service back up Privacy of the patient during blood collection should be Training provided and the needs of patients with disability should be Complexity of equipment - how easy is it to operate considered Special operational requirements e.g. de-ionized water Storage and disposal of dangerous materials shall be those Emergency power and waste disposal speciﬁed by relevant regulations Will reagents be provided free of charge for a limited time? The premises shall have staff facilities that are readily accessible and include: accuracy ! Equipment Managment Program ★ Sufﬁcient toilet accommodation ★ Shower facilities when required Helps maintian high elevel of laboratory performance T ★ Rest area Reduces variation in test results ★ Basic catering facilities and access to a supply of Improves technologists’ conﬁdence in results drinking water Lower repair costs ★ A changing area and secure storage for personal Lengthens instrument life effects Reduces interruption of service due to breakdowns and failure ★ Storage for protective clothing Increases safety for workers ★ Safe and secure working arrangement Produces greater

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