MT105 Principles Of Medical Laboratory Science Practice 1 (PMLSP1) PDF

MT105: PRINCIPLES OF MEDICAL LABORATORY SCIENCE PRACTICE 1 (PMLSP1) UNIT 1: OVERVIEW OF THE MEDICAL TECHNOLOGY / MEDICAL LABORATORY SCIENCE PROFESSION WHAT IS MEDICAL TECHNOLOGY? “...application of the p...

MT105: PRINCIPLES OF MEDICAL LABORATORY SCIENCE PRACTICE 1 (PMLSP1) UNIT 1: OVERVIEW OF THE MEDICAL TECHNOLOGY / MEDICAL LABORATORY SCIENCE PROFESSION WHAT IS MEDICAL TECHNOLOGY? “...application of the principles of natural, physical, and biological Ruth Heinemann sciences to the performance of laboratory procedures which aid in the diagnosis and treatment of diseases.” “…branch of medicine concerned with the performance of laboratory Anne Fagelson determinations and analyses used in the diagnosis and treatment of disease and the maintenance of health.” “...health profession concerned with performing laboratory analyses in Walters view of obtaining information necessary in the diagnosis and treatment of disease as well as in the maintenance of good health.” “...an auxiliary branch of laboratory medicine which deals with the examination of tissues, secretion, and excretion of the human body and body fluids by various electronic, chemical, microscopic, and other RA 5527 medical laboratory procedures or techniques either manual or automated which will aid the physician in the diagnosis, study and treatment of disease and in the promotion of health in general.” WHAT IS COMMON AMONG THEM? Performing Laboratory Diagnosis and Treatment ANALYSIS (RESULTS) Procedures (Samples) (Disease)  CLINICAL It is a facility that performs chemical and microscopic LABORATORY examinations of various body fluids. Inside the Clinical Laboratory Pathologist Medical Technologist Medical Technician  Took the boards but  The head of the  Guide/provide grades fell quite a bit. clinical laboratory instruction for patient  Have an assisting role  Capable of what collection  Prepare agents and MedTech can do  Collect samples check machines  Second pair of hands  One who run/analyze to check the results the sample  Still PRC certified and can run test but with  Do the more complex  Process tissue (after the supervision of analysis surgery) medical technologist  Biopsy/autopsy/pop-  Assist in determining  Can only be seen in smear tissue readings Philippines ROLES OF MEDICAL TECHNOLOGIST Medical Detectives Observe, identify, and analyze organisms and cells causing infection and disease Perform blood tests Measure substance in blood and other body fluids WHAT DOES A MEDICAL Operate complex apparatus, instruments, and TECHNOLOGIST DO? machines Use standards and controls to improve reliability of results Work under pressure with accuracy and precision Adhere to high ethical standards of performance HISTORY OF MEDICAL TECHNOLOGY 400 B.C. Father of Medicine Described the “four humors” Hippocrates in man (blood, phlegm, yellow bile, and black bile) Oldest laboratory procedure EARLY BEGINNINGS Urinalysis - Through visual analyzation 600 B.C. Recorded the sweet taste of diabetic urine as well as Hindu physicians polyuria in diabetes - Use ants  1500 B.C. Identified Taenia (flat worm) and Ascaris (round worm) Vivian Herrick - parasites than can invade human) Oldest preserved Egyptian compilation of medical texts - contains chapters about pregnancy, “Ebers Papyrus” contraceptions, eye and skin problems, surgery, burns, and other intestinal diseases and parasites. 1632 Invented the compound microscope - can only describe morphology of blood cells, parasites and Anton van Leeuwenhoek bacteria First to described red blood cells, protozoa, and to classify bacteria according to shape 1628 – 1694 Founder of Pathology (study of diseases, diagnosis) Greatest of the early Marcelo Malphigi microscopists Contributed to embryology and anatomy 1847 Founder of the “Archives of Rudolph Virchow Pathology” in Berlin 1848 Performed the first Herman Fehling quantitative test for urine sugar th 15 Century Discovery of aniline dyes Staining of microorganisms IN UNTED STATES 1978  Established a laboratory at Bellevue Hospital Medical College Dr. William H. Welch First professor of Pathology at John Hopkins University (1885) - pioneers 1896 Opened the first clinical laboratory at John Hopkins Dr. William Osler Hospital William Pepper Laboratory was opened at the University of Pennsylvania 1908 Wrote “A Manual of Clinical Diagnosis” which became the Dr. James C. Todd standard reference of laboratories Denver Society of Clinical 1921 Pathologists was organized American Board of Pathology 1936 was organized WORLD WAR 1 Produced a great demand for technicians. - Technicians was taught by pathologists. One of the first schools to establish trainings for University of Minnesota workers in 1922 First to offer degree program in 1923 WORLD WAR II (1939-1945) “Closed system” of blood collection was adopted Automated equipment (No entry for microbes) Advanced instrumentation Quality control programs JANUARY 9, 1945 26th Medical Infantry of the IN THE PHILIPPINES 6th U.S. Army (went to the First Clinical Laboratory Philippines to establish clinical lab)  Located at Quiricada St., Sta. Cruz, Manila Known as Public Health Laboratory OCTOBER 1, 1945 Dr. Pio de Roda (head) and Reopened as Manila Public Dr. Mariano Icasiano (from Health Laboratory local health unit) 1947 Offered a training for high Dr. Pio de Roda and Dr. school and paramedical Prudencia Sta. Ana graduates 1954 Formal syllabus Dr. Pio de Roda instructed Dr. 6 months laboratory training Sta. Ana (with Briones) was offered “The training program offered by Dr. Pio de Roda did not last long, for during the same year, the formal education of Medical Technology in the Philippines began.” FORMAL MEDICAL TECHNOLOGY EDUCATION IN THE PHILIPPINES Founder of medical technology education in the Philippines Mrs. Willa Hilgert – Hedrick American medical practitioner of the Seventh Day Adventist Church in the Philippines Adventist HISTORY First to offer B.S. Medical Technology Dr. Jesse Umali: fast to graduate after two year Philippine Union College of Baesa (1954) Now called Adventist University of the Philippines Training was done at Manila Sanitarium Hospital (sister institution) Dr.Antonio Gabriel and Dr. Gustavo Reyes Offered MT as an elective to pharmacy students University of Santo Tomas (1957-1958) Due to its popularity, it was decided to be offered as a course June 14, 1961: recognition of 4-year B.S. MT Centro Escolar University (1960) First batch graduated in 1962  Dr. Horacio Ylagan and Dr. Serafin Juliano Applied for the offering of B.S. Medical Far Eastern University (1962) Technology course First batch graduated in 1963 Offers the same course but the degree is University of the Philippines conferred to as B.S. Public Health PROFESSIONAL ORGANIZATIONS Philippine Association of Schools of Medical Technology PASMETH Have highest standards Build relationship with school Philippine Association of Medical Technologists PAMET Mother organization of all medical technologist Organized by Mr. Crisanto Almario MEDICAL TECHNOLOGY EDUCATION IN THE PHILIPPINES Program course shall be called as: Bachelor of Science in Medical Technology or Bachelor of Science in Medical Laboratory Science Four - year program: NATURE OF THE FIELD OF STUDY One-year internship with rotational duties in different laboratory sections in a CHED- accredited training laboratory Passed the licensure examination Develop knowledge, skills, professional attitude and values in the performance of laboratory procedures Acquire critical thinking skills Engage in research and community – related PROGRAM GOALS activities Participate in activities promoting the profession and engage in life-long learning undertakings Develop collaborative and leadership qualities Technical competence EXPECTED PERFORMANCE Analytical and critical thinking skills (think OUTCOMES what could go wrong)  Proper collection, analysis, and projection of health information Interpersonal skills, leadership qualities, and ethical practice of profession Research skills Community-oriented activities Life-long learning activities Effective teaching and communication skills General Education PROGAM CURRICULUM Core Courses Professional Courses CHED Memorandum (CMO-13s. 2017)  Clinical Chemistry 20% Microbiology and 20% Parasitology Hematology 20% SCOPE OR THE LICENSURE Blood Banking and 20% EXAMINATION Serology Clinical Microscopy 10% Histopathological Techniques and MT 10% Laws EMPLOYMENT OPPORTUNITIES FOR MEDICAL TECHNOLOGY GRADUATES 1. Medical Technologist - Specializing one section in the (Generalist/Specialist) laboratory 2. Clinical Laboratory Supervisor Gained a lot of experiences. 3. Chief Medical Technologist  You may own the laboratory but there should 4. Laboratory Owner be a pathologist as the head of the laboratory. (Ex. Hi-Precision) Be part of diagnostic company 5. Sales and Public Relations Part of sales to sell diagnostic equipments Representative Training for staff Med Tech for new equipment 6. Educational Representatives Can be trainers of new medical technologist (Company/Health Program) Be part of a research (group/individual) 7. Researcher (Industrial/Medical) Clinical trials 8. Teacher/Instructor (Secondary/Tertiary Levels) 9. Employment Abroad Require local licensure Policy health development sector (like DOH) Development of guideline 10. Government World Health Organization Development sectors like UNICEF, UN Agencies  UNIT 2 CLINICAL LABORATORY CLINICAL LABORATORY o Facility o Specimens (whole blood, serum, plasma, urine, stool, etc) from the human body o Collected, processed, examined or analyzed o Prevention, diagnosis & treatment CLASSIFICATION OF CLINICAL LABORATORY DEPARTMENT OF HEALTH Administrative Order no. 2007 -0027 A. Based on Ownership (kanino nakapangalan and sino nagmamanage) 1. Government – national government or local government 2. Private – private sector like individual/organization/corporation like Hi-Precision B. Based on Function 1. Clinical Pathology – clinical lab where specimens are processed, sections like hematology, clinical chemistry, “routine laboratory” 2. Anatomical Pathology – tissue processing takes place (histopathology like biopsy, autopsy, papsmear) C. Based on Institutional Character (based-on how the laboratory operates) 1. Institution-based – operates within the premises or as part of the institution ex. laboratory in a hospital, laboratory in a clinic, laboratory in school/medical facility, close centers like rehabilitation centers, nursing homes 2. Freestanding – clinical laboratory that does not part of any institution, purely medical laboratory, without any attached institution/clinic ex. Hi-Precision, New World D. Based on Service capability 1. General Clinic laboratory – carries the routine test, day-to-day laboratory test 2. Special Laboratory – have test that are highly specialize (bihirang i-request/i-conduct) like hybridization, FISH, stem cell therapy E. National Reference Laboratory – owned by the government and usually attach to a government hospital, provide laboratory services for confirmatory testing, surveillance, resolution of conflicting results, research, perform evaluation testing for diagnostic kits and reagents, hearing out EQAP (External Quality Assurance Program) – to check performance of various clinical laboratory across PH, send a standardized sample to all the clinical laboratory that perform a specific test, check accuracy of the sample results 1. Confirmatory testing  2. Surveillance 3. Resolution of conflicting results 4. Training and research 5. Evaluation of diagnostic kits and reagents F. Satellite Testing Sites o The testing site is owned by a licensed laboratory but situated some distance from the main laboratory. o Have extensions near to the patients o Ex. Molecular diagnostic labs G. Mobile Clinical Laboratories – bring laboratory to the patients, from testing site to another, temporary location, has a base laboratory o laboratory testing unit o moves from one testing site to another testing site o has a temporary testing location o shall have a base laboratory o permitted to collect specimens only o operate within a 100-km radius from its main lab CLASSIFICATION OF CLINICAL LABORATORY (BASED ON FUNCTION) A. Clinical Pathology – focuses on the analysis of body fluids that includes the following 1. Clinical Chemistry 2. Hematology 3. Microbiology 4. Clinical Microscopy 5. Immunology 6. Molecular Biology - pcr 7. Immunohematology 8. Cytogenetics 9. Endocrinology 10. Toxicology 11. Therapeutic drug monitoring B. Anatomical Pathology 1. Surgical Pathology - practice or study of tissue samples removed during surgery 2. Immunohistopathology – immuno (use of antibodies), microscopic study of tissues with the aid of antibodies 3. Cytology – involved single cells/cluster of cells 4. Autopsy – study of examination of dead bodies (cause of death, identifying the dead person) 5. Forensic Pathology – determining cause of death 6. Molecular Pathology – examination of molecules between organs CLASSIFICATION OF CLINICAL LABORATORY (BASED ON SERVICE CAPABILITY) 1. General Clinical Laboratory a. Primary Category – minimum test or test that every laboratory should have o Routine hematology (CBC) o Qualitative platelet determination – don’t count the platelet but it is qualified if it is rare, moderate o Routine urinalysis and fecalysis – urine test strip, centrifuge and microscope – involves physical qualities, testing, if it is cloudy, what color, see differents amalyte in urine, pH o Blood typing – for hospital based o Working space - minimum of 10 square meters in floor area (Now: 62 sq/m) b. Secondary Category – (some are still not automated) all routine included in the primary category plus the following: o Routine Clinical Chemistry o Quantitative platelet determination – actual count o Cross matching o Gram staining o KOH staining for fungal disease – Potassium Hydroxide for visualization of fungi o Working space - minimum of 20 square meters in floor area (Now: 110 sq/m) c. Tertiary Category o All secondary lab services o Special chemistry (Cardiac markers) – progression of cardiac arrest o Special Hematology (coagulation tests) o Immunology/Serology (HIV, hepa profile, tumor markers-checkigg rsk for developing cancers) o Microbiology – culture (pinapatubo yung organism sa petri dish) and sensitivity (put antibiotic disk to test sesitivity) o Working space - Minimum of 60 square meters in floor area (Now: 160 sq/m) d. Limited Service capability – still routine but have llimited services, not all routine for primary, secondary, tertiary can be done o Dialysis centers – dialysis, blodd typing o Social hygiene clinics – HIV testing, screening for STD/hepatitis 2. Special Clinical Laboratory – offers highly specialize laboratory services that are not usually provided by a general clinical laboratory, not routinely done a. Assisted reproduction technology laboratory – stem cells, in-vitro labs b. Molecular and cellular technology c. Molecular pathology, Forensic pathology and Anatomic laboratory ADDENDUM AO 2021-0037: New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines o Fecal Occult Blood Test – colon cancer (occult means hidden) o Trichomonas -sexually transmitted infection o AST – Aspartate Amino Amalytes o When a patient test positive – send to the reference lab NATIONAL REFERENCE LABORATORY I. RESEARCH INSTITUTE FOR TROPICAL MEDICINE o Molecular testing for viruses/microorganism o NRL for dengue, influenza, tuberculosis (TB), malaria (quantitation), intestinal parasites, other viral diseases, emerging diseases, antimicrobial resistance o Confirmatory for blood donor and blood units o Alabang II. San Lazaro Hospital STD-AIDS Cooperative Center Laboratory (SACCL) o NRL for HIV/AIDS, hepatitis, syphillis, STDs III. EAST AVENUE MEDICAL CENTER o NRL for environmental and occupational health, toxicology testing (drug testing), micronutrient assay, water analysis IV. NATIONAL KIDNEY AND TRANSPLANT INSTITUTE o NRL for hematology, coagulation, immunohematology/blood banking services V. LUNG CENTER OF THE PHILIPPINES o NRL for clinical chemistry (glucose, creatinine, cholesterol,blood urea nitrogen, uric acid, total protein, albumin, sodium, potassium, chloride) LABORATORY SECTIONS A. SPECIMEN PROCESSING – accessioned to the computer (put labels), transportation to respective section in the laboratory and also to the NRL B. HEMATOLOGY SECTION – disorders like anemia (namumutla), leukemia (abnormal production of white blood cells), Dengue for platelets, peripheral blood smear (checking for abnormal blood cells) o Lymphocyte – increase when patient have viral infection o Eosinophil – parasitic infection o Neutrophil – increases when there re bacterial infection o Basophil – probably an allergic reaction but not definitive o Neutrophil and lymphocyte have the most number. Neutrophil followed by lymphocytes, monocyte then eosinophil then basophil C. COAGULATION SECTION – disorder in bleeding and clotting o Hemophilia – matagal magstop yung bleeding o Anti-coagulant therapy – prevention of clot formation in the bloodstream D. CLINICAL MICROSCOPY – screens all non-blood body fluids, fertility testing, o Urine Examination - mid stream clean catch   Macroscopic examination – check on the gross appearance of the urine (volume, color, turbidity)  Chemical examination – check for chemical analytes like pH, osmolarity, protein levels, creatinine, and sugar level  Microscopic examination – check particles present in the sample under the microscope, wet mount E. PARASITOLOGY – stool sample o Fecalysis, occult blood, fecalysis for fat globule, parasite identification F. CLINICAL CHEMISTRY. – analysis, quantitative analysis o Spectrophotometry, electrophoresis o glucose, lipid profile, hormones, electrolytes, proteins and other metabolic product o Usually use serum sample o Serum – coagulated blood (more clear due to its clotting) o Plasma – uncoagulated blood G. CLINICAL MICROBIOLOGY o Identify microorganism that causes the disease o Culture (bacteria, some fungi) – let a bacteria grow in a culture, colonies o biochemical test or oxidase text o Sensitivity – antibiotic sensitivity test H. IMMUNOLOGY/SEROLOGY SECTION o Check antibodies or antigen o Diagnosing infectious disease as well o Inflammatory markers o Testing for typhoid, hepatitis b, o Pregnancy tests – detects B-HCG (beta – Human chorionic gunadotropin (found in placenta) o Dengue Test – immunodumatographic – check for antigen/AbIgm/IgG) o Antigen – Ag: Nsl, Ab - antibodies: Igm(high when infection is new),IgG (low when infection is in the later stage / indication previous disease o HbsAg (Hepatitid B Serface Antigen) – for hepatitis o Bacterial Agglutination test a. Widal test - Typhoid fever b. Weil-Felix – non specific test for typhus fever I. IMMUNOHEMATOLOGY (BLOOD BANK) o Compatibility testing J. HISTOPATHOLOGY (solid tissues – biopsy)/CYTOPATHOLOGY (smears of cells) o Anatomical section INFORMATION FLOW IN THE CLINICAL LABORATORY  Laboratory requisition o A form used by physician to document the tests that are to be performed on patients. o Contains the following:  Patient's demographic data: name, data, address, birth date  Patient Gender  Date & time of collection  Room number (in-patient or out-patient)  Test slection  Date and time of collection  Identification of the person who performed the collection  Name and signature of ordering physician  Source of specimen  Physician's clinical Diagnosis  Additional comments  Laboratory Directory 1) Internal test number 2) Acronyms or abbreviations of the test 3) Type of specimen required 4) Specimen volume and the minimum acceptable volume 5) Collection notes 6) Storage instruction of specimen 7) Stability of the specimen 8) Reference Ranges 9) Clinical Significance 10) Test schedule or testing interval/frequency 11) Method  Laboratory Reports 12) to transmit test results 13) Reference ranges 14) Date and time of the specimen collection 15) Name, address of the laboratory 16) Name and identification number of patient Source of specimen 17) Date & time the report was generated THREE PHASES OF LABORATORY TESTING I. PRE-ANALYTICAL PHASE o Occurs first in the laboratory process  Patient preparation  Paper work and data entry  Specimen collection, processing, storage and transportation. o Responsible Personnel   Phlebotomist, laboratory technician II. ANALYTIC PHASE o Considered the “actual” laboratory testing or the diagnostic procedures, processes and products  Proper instrument maintenance  Reagent supplies  Quality control  Ensure Accuracy, precision, and reliability of the test procedure.  Validates the following: a) Test reagents/ kits b) Testing process c) Training of the lab personnel performing the test o Responsible Personnel  Medical Technologist or Medical Lab Scientist III. POST- ANALYTIC PHASE o Includes the following:  Review and analysis of results  Recording and reporting of test results  Storage and disposal of specimen  Releasing of results o Responsible personnel  Medical Technologist, Section Supervisor, Chief Med. Tech., office clerk or staff LABORATORY POLICIES 1) Laboratory hour and emergency work o definite working hours o outside regular working hours, organize a system for testing urgent specimens. 2) Range of tests to be performed and those to be referred to higher level o the number of staff available o the availability of material resources o the types of health institutions (hospital or health center) 3) Referral of specimens (when necessary) o Example specimens for HIV detection and water samples for bacteriological analysis 4) Collection of laboratory specimen 5) Workload capacity of a laboratory o should matched to the number of staff o their level of training o size of the laboratory o the availability of laboratory facilities  MT105 UNIT 3: REGULATIONS GOVERNING LABORATORY PERSONNEL INQUIRY STIMULUS Legal and ethical issues in the laboratory: 1. Identify the different laboratory personnel? 2. What are the functions of each of the laboratory personnel? 3. Construct the personnel structure of the laboratory professionals. 4. Identify the legal and ethical issues in the laboratory environment? Described the patient's bill of rights and responsibilities. ORGANIZATION OF THE LABORATORY MEDICAL LABORATORY PROFESSIONALS o skilled and educated laboratory professionals o play a very important role in health care o responsible for conducting tests that provide crucial information for detecting, diagnosing, treating, and monitoring disease o Clinical Laboratory Team  Laboratory Director/Head Pathologist   responsible for managing overall operations within the laboratory, including maintaining the standards of agencies that inspect and accredit the lab and ensuring that all technical, clinical, and administrative functions of the lab are performed. 1. Pathologist  board certified physicians who have specialized training in disease and laboratory interpretation.  Perform all levels of testing  Affiliated with hospital and reference lab o Bachelor>Medicine Proper>Internship>Licensure Exam>Residency>Specialized Exam 2. Physician  A physician without any laboratory specialty training  With additional credentials specially qualifying for the laboratory setting  Laboratory Administrator/Laboratory Manager  Responsible in overseeing all operations involving Laboratory services  Managerial duties generally include scheduling staff, reordering supplies and maintaining security standards  Registered technologist with an advanced degree and several years of experience  Technical and Laboratory Supervisors  A general supervisor is responsible for oversight of the day-to-day laboratory. operations as well as the personnel conducting the tests and reporting results.  Laboratory manager  a medical doctor (MD) with certification in anatomic and/or clinical pathology  scientist with a PhD, a Master's degree, or a bachelor's degree in addition to acquiring the appropriate laboratory experiences)  Medical Technologist/Medical Laboratory Scientist/Clinical Laboratory Scientist  performing routine as well as highly specialized tests  to diagnose and /or aid in the treatment of disease and troubleshooting  perform quality control checks  may assume managerial roles  have a bachelor's degree in clinical/medical laboratory science  three or four years of academic course work and one year of clinical experience  Certified by PRC. AMT, or ASCP  Medical Laboratory Technician/Clinical Laboratory Technician  Performs routine tests in all areas of the clinical laboratory  Have an associate degree and have completed an accredited Clinical Laboratory Technician or certificate program  Phlebotomist   Phlebotomists, sometimes called phlebotomy technicians, work directly with you the laboratory tests using venipuncture or skin puncture.  Other Laboratory Personnel  LIS Managers  Quality Assurance (OA) Manager  Point-of-Care Coordinator  Safety Officer PROFESSIONAL ORGANIZATION o Philippine Association of Medical Technology (PAMET)  Non-stock and non-profit organization  Only accredited professional organization for RMT in the Philippines  Organized by Mr. Crisanto Almario (Father of PAMET) on September 15, 1963  September 20, 1964: first national convention of PAMET held at FEU  Registered at SEC on October 14, 1969 with regs no. 39570  Regs during the term of M.r Nardito Moraleta as president  With 47 provincial chapters  PAMET Presidents 1. Mr. Charlemagne T. Tamondong (1963-67): Emergence of the Profession 2. Mr. Nardito M. Moraleta (1967-1970): Professional Recognition 3. Mr. Felix E. Asprer (1970-71, 1973-1976): Legislative Agenda 4. Mr. Bernardo T. Tabaosares (1971-1973): Celebration of the Practice 5. Miss Angelina R. Jose (Jan-Sept.1973): Career Advocacy 6. Miss Venerable C.V. Oca (1977-Feb.1982): Educational Advancement 7. Miss Carmencita P. Acedera (1982-1992): Image Building 8. Mrs. Marilyn R. Atienza (1992-1996): Proactivism 9. Dean Norma N. Chang (1996-2000): International leadership 10. Ms. Agnes B. Medenilla (2000-2002, 2005-2006): Organizational Dynamism 11. Dr. Shirley F. Cruzada (2003-2004): Interdisciplinary Networking 12. Dr. Leila M. Florento (2006-2013): Global Perspectives 13. Mr. Romeo Joseph Ignacio (2013-2015): Golden Celebration 14. Mr. Rolando E. Puno (2015-2020): Empowerment 15. Mr. Rommel F. S a c e d a (2020-2022): Engagement  16. Ms. Luella A. Vertucio (2022 - present): growth of laboratory professionals  PAMET Insignia  The Circle – continuous involvement where practice and education aer always integrated  The Triangle – trilogy of love, respect and integrity  Green – health  Microscope&snake – MT Profession  1964 – first PAMET election  PAMET LOCAL A N D INTERNATIONAL AFFILIATIONS  LOCAL AFFILIATIONS: 1. Council of Professional Health Association (COPHA) 2. Philippine Federation of Professional Association (PFPA) 3. Council of Health Agencies of the Philippines (CHAP) 4. Philippine Council for Quality Assurance in Clinical laboratories (PCOACL) 4. Alliance of Allied Health Organizations of the Nation (AAHON)  INTERNATIONAL AFFILIATIONS: 1. ASEAN Association of Clinical Laboratory Scientists (AACLS) 2. ASIA Association of Medical Laboratory Scientists (AAMLS) 3. International Federation of Biochemical Laboratory Scientists (IFBLS) 4. Asia Pacific Federation of Clinical Biochemistry (APFCB). 5. International Federation in Clinical Chemistry (IFCC) o Philippine Association of Schools of Medical Technology and Public Health (PASMETH), Inc.  PASMETH INSIGNIA  Circle – represents the continuity of learning and the never-ending quest for excellence in the academic field.  Diamond – the four corners represent the four objectives of the association.  Microscope – represents the field of Medical Technology and Public Health  1970 – the year the Association was founded  National organization of about 50 recognized schools of medical technology in the Philippines  Formed in 1970  To maintain the highest standard of Medical Technology/Public Health education  To foster closer relations among schools  Director Narciso Albarracin appointed Dr. Seratin Juliano to lay the foundation of the association on May 13, 1970  First organizational meeting held at UST on June 22, 1970   First annual meeting was held at UST on May 7, 1971  Dr. Gustavo Reyes, President (1970- 1973)  PASMETH Presidents 1. Dr. Gustavo Reyes, President (1970-1973) – UST 2. D.r Ibarra Panopio (1973-74) – Velez College 3. D.r Angelita G. Adeva (1974-75) – UST 4. D.r Elizabeth M. del Rio (1977-81) – Martinez Memorial Colleges 5. Dr. Norma V. Lerma (1983-84) – UST 6. Dr. Vivencio T. Torres (1984-85) – University of Luzon 7. Prof. Nardito Moraleta (1985-88) – FEU 8. Dean Norma N. Chang (1988-96) – San Juan de Dios Educational Foundation Inc. 9. Prof. Rodolfo R. Rabor (1996-99) – UST 10. Dr. Nini Festin-Lim (1999-2002) – PWU 11. Dean Zenaida Cajucom (2002-2010) – World Citi Colleges 12. Dean Magdalena F. Natividad (2010-2012) – FEU 13. Dean Bernard U. Ebuen (2012-present) – Arellano  Formally registered with SEC o n October 6, 1989 by M.r Cirilo S. Cajucom and Aty. Dexter Bihis (PASMETH legal council)  PASMETH Accomplishment: 1. Continuing professional education program for medical technology faculty 2. Preparation of a standard curriculum for BS Medical Technology schools 3. Preparation of a standard course syllabi tor professional subjects in Medical Technology 4. Scholarship grants for MedTech students 5. Community outreach projects 6. Recognition to graduates of BS Medical Technology Course (PASMETH Gold Medal for Excellence Award) 7. Accreditation as CPE Provider for medical technologists. PROFESSIONAL CODE OF CONDUCT o Objectives  Code of Ethics of the Medical Technologist (New Version)  Ethics  Principles of conduct governing an individual or a group  Jett Cooper in Albany Medical Center, Ethical Decision Making, 2001, p. 1  "Ethics is the disciplined study or morality...and morality asks the question...what should one's behavior be.”   Descriptive Ethics  What does the culture or society believe is morally correct?"  What is right or wrong for the society  Develop conceptual models and test those models clinically in order to enhance our understanding of ethical or moral behavior, moral decision making, more broadly moral phenomenon  Prescriptive Ethics  "How should I behave as a researcher or professional?"  "What character traits should I cultivate?"  Entails knowing your own belief and decision on what is right and what is wrong  Descriptive ethics is the way people thinks thing or most times the way things are. So it is what we accept as people or generally. While in Prescriptive Morality or Normative Ethics is the way people thinks should be and things need to be changed. It is more on individual thinking.  Descriptive and Prescriptive can also be differentiated in this instance, example, when we say, “All people are created equal an as in as equal in the eyes of the law.” That quote pertains to descriptive morality because that is what the society believe that is morally correct but in prescriptive morality, we identify individuals as well, prescriptive essay phrases it as “All people, race, creed or color are created equal. Everyone aforementioned should be treated equal by the law and we must uphold this in our society.” We quote unquote “prescribe” what needs to be done.  Why do we need to define this two?  It is important in the practice of clinical laboratory science because when we practice the profession, we would have a lot of questions to answer pertaining to ethics, “what is morality right and what is morally wrong for you?,” “what needs to be done?,” or “what is the prescribed things that we must do in order to protect our patients or improve the health of our patients?” That is why as early as now we must establish and build our values as a professional during our formative in college.  Joan E. Sieber in Planning Ethically Responsible Research, p. 3  "Greek ethos 'character' is the systematic study of value concepts-good, bad, right, wrong and the general principles that justify applying these concepts.”  Objectives of the Professional Code of Ethics 1. Define professional privileges, behaviors and responsibilities towards the members of the community in general. 2. Promote professional quality, professional conduct and a moral method of procedures.   So as an individual how should you professionally behave. 3. Defend private professions from undue interference by the government or by other private agencies. 4. Preserve the dignity of the profession and the confidence of the public. 5. Defend clients from unscrupulous individuals for the benefit of the patients as well. 6. Certain standards of the compensations for services or work.  Code of Ethics of Medical Technologist (New Version)  Specific Principles of Professional Conduct 1. Service to Others 2. Integrity and Objectivity 3. Professional Competence 4. Solidarity and Teamwork 5. Social and Civic Responsibility 6. Global Competitiveness 7. Equality of All Professions (no judgement or discrimination towards other professions)  Ethical Practice of Laboratory Medicine (by WHO)  Ethical practice – good technical practice accompanied by proper attitude and behavior. (In everything that we do we must practice ethical standard or ethical behavior. We have to identify what is right and what is wrong.)  Fundamental Principles of Ethics 1. Autonomy  the right of patients to make decisions on their behalf.  As medical professionals we know technically or scientifically what’s the course of treatment or diagnostic procedures that the patient should undergo. But as health professionals we should also respect the right of the patient to decide for his or her own or their designated relatives or individuals to execute their will, wishes or what they want to do. If they are unconscious, by default, the family member will decide as they have a special power of attorney. Like DNR, we don’t have the right to push otherwise, we must respect that. 2. Beneficence  the duty or obligation to act in the best interest of the patient.  Be able to practice our profession by only doing what we think is the best or for the best interest for the patient. We must also act on good faith for the best of the patient. It’s not for us to gain more, like adding more laboratories for the gain of the hospital. It is an unethical practice because it is beyond whats needed by the patient even though it is not needed because it is our responsibility to act only considering what’s best for the patient.  Application of the Beneficence Principle: Risk-Benefit Assessment  The four categories of risk (Levine, 1988 ni Weijer, 2000): a. Physical risks – complications, outcome, success rate b. Psychological risks – when undergoing surgery c. Social risks d. Economic risks – overall cost (also include maintenance drugs)  Comparison of risks of a situation and its benefit. Example, the consideration whether to conduct a test or a dangerous surgery/operation to a patient. Those instances, the physician carefully discusses/assess the dangerous operation that needs to be conducted. What is the possible risk physically, psychologically, socially, and economically, as well as it’s possible complication, outcome, and success rate. 3. Non-maleficence  the duty or obligation to avoid harm to the patient.   Do no harm and consider which test or procedure would benefit the patient more. Must also consider the idea that the benefits should outweigh the risk. 4. Justice  this embodies concepts of fairness and giving what is rightfully due.  Try to break the barriers to access, we must be able to be fair in providing healthcare access and in giving what is best for the patient regardless of social status. This is where issues about the private and public hospital due to barrier to access healthcare because it limits the access of the patients that badly need the test.  General Application of Ethical Principles 1. Medical laboratories have responsibilities to others.  Patients  Colleagues and the Profession  Society 2. Collection of Information 3. Collection of Specimens 4. Performance of Test 5. Reporting of Results 6. Storage and Retention of Medical Records 7. Access to Medical Records 8. Financial Arrangements and organizational matters.  We collect patient’s information and specimen, so the patient is very vulnerable as it is possible source of exploitation for them. So as medical professional, we must adhere to ethical principles and must always think of the best interest for the patient. We must adhere to confidentiality rules as well because we should not disclose laboratory results whether it is very sensitive or mundane laboratory results, like results of celebrities as it is unethical. Though in hospital there is what we called shared confidentiality, where in it is only applicable to health professionals who have direct involvement and who are working for the patient.  Organizational matters are very crucial when we receive specimens where there is issue involved or have a high-profile criminal court cases like drug testing. It is very important that we adhere to the so called “chain of custody” and the confidentiality of the result. Because for example if the test results are tampered in the chain of custody (the chain of individual that should handle the specimen), the chain of custody should be kept intact and n such cases there is a possibility of corruption like bribery to change the result. It should be a possible ground for revocation of your license.  Philippine Regulations on Laboratories   Clinical Laboratory Regulations  Clinical Laboratory Law in 1965, which required the Licensing of clinical laboratories by the Bureau of Research and Laboratories, Department of Health (BRL, DOH) before they can operate.  REPUBLIC ACT NO. 4688 or Clinical Laboratory Law  AN 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 THEREOF, AND FOR OTHER PURPOSES  In 1968, the Philippine Society of Pathologists (PSP) decided to accredit clinical laboratories for Residency Training Program in Anatomic and Clinical Pathology.  In 1989, after realizing the serious implications of HIV Testing, the DOH mandated the BRL, DOH to set standards for clinical laboratories performing HIV testing.  In 1997, upon request of the Philippine Health Insurance Corporation (PhilHealth), the PSP formulated and submitted standards for the accreditation of clinical laboratories, both hospital and free-standing, for reimbursement of fees for laboratory services rendered to patients enrolled in the PhilHealth social insurance program.  PhilHealth coverage per disease as package from screening, diagnosis, treatment until further management of the patient after the diagnosis of the disease  But PhilHealth can’t cover everything, the best that they can do is to reduce the cost.  In 2000, the Philippine Council for Accreditation of Healthcare Organizations (PCAHO) approved the Standards for the accreditation of Hospitals for the provision of quality medical services. Included were the standards for the Department of Pathology. UNIT 4: LABORATORY ACCIDENTS AND SAFETY  Types of Safety Hazards TYPE SOURCE POSSIBLE INJURY Biologic Infectious agents Possible Injury Needles, lancets, broken Bacterial, fungal, viral, or Sharps glass parasitic infections Cuts, punctures, or blood- Chemical Preservatives and reagents borne pathogen exposure  Exposure to toxic, Equipment and carcinogenic, or caustic Radioactive radioisotopes agents Radiation exposure Burns or shock Ungrounded or wet Electrical Burns or dismemberment equipment; frayed cords Open flames, organic Fire/ explosive Falls, sprains, or strains chemicals Wet floors, heavy boxes, Physical Possible Injury patients From Strasinger, SK, and DiLorenzo, MA: The Phlebotomy Textbook, third edition, FA Davis, Philadelphia, 2011, p 52, with permission.  Biological Hazards o potentially harmful microorganisms  frequently present in the specimens o chain of infection o infection control  Chain of infection and safety practices related to the biohazard symbol  Biological Safety Cabinets o Class I  Open front. Unsterilized room air enters. Ari passes through high- efficiency particulate air (HEPA) filter before being exhausted. o Class II  Laminar flow cabinets with variable sash opening. Ari passes through 1HEPA filter before reaching work surface & 2nd one before being exhausted. o Class III   Completely enclosed. Negative pressure. Air is filter sterilized coming in &going out. Gloves are attached to front. o All biological safety cabinets use HEPA filters to treat air inflow/exhaust.  Two types:  Class I: provide worker and environmental protection, but no product protection. Exhaust air filtered.  Class Il: filter both exhaust and intake air to protect the worker and the environment from contamination as well as to protect product in the cabinet. Suitable for microorganisms assigned to bio-safety levels 1,2 and 3.  Biosafety Levels LEVEL RISK TYPES OF AGENTS EXAMPLESOF AGENTS PRECAUTIONS Those not known to Bacillus subtilis, Standard microbiological I Minimal cause disease in Mycobacterium gordonae, practices. No special equipment. healthy adults soil microbes Biological safety cabinet (BSC) or lI. Personal protective equipment Common human E.coli, Salmonella, HIV, II Moderate (PPE). Autoclave must be pathogens HBV, influenza available. Limited access. Most micro labs fall in this category. Bacillus anthracis, Those that may Francisella, Brucella, cause serious or Mycobacterium Same as above plus negative air III High lethal disease via tuberculosis, Rickettsia flow, sealed windows. inhalation. Effective rickettsii, Coxiella burnetii, treatment available mold stages of systemic fungi Those that pose high Requires use of class Il BSC; full- risk of life-threatening body, air-supplied positive Ebola virus, Lassa virus, dis- ease. May be pressure suit; independent unit IV Extreme others that cause transmitted by with specialized ventilation & hemorrhagic fevers aerosols. No vaccine waste management to prevent or therapy release into environment.  Classification of Biological Agents CATEGORY PRIORITY SPREAD IMPACT EXAMPLES Bacilus anthracis, Yersinia pestis, Easily High mortality, Francisella tularensis, Clostridium disseminated or A Highest potential for major botulinum toxin, smallpox, hemorrhagic transmitted from public health impact fever viruses (Ebola, Marburg, Lassa, person to person Machupo) Brucella, Salmonella, Shigella, E. coli 0157:H7, Burkholderia mallei, Burkholderia pseudomallei, Chlamydia psittaci, Coxiella burnetii, Clostridium Moderately easy Moderate illness, B 2nd Highest perfringens toxin, ricin toxin, to disseminate low death rate staphylococcal enterotoxin B, Rickettsia prowazekii, viral encephalitis viruses, Vibrio cholerae, Cryptosporidium parvum Could be High Nipah virus, hantavirus C 3rd Highest engineered for morbidity/mortality,  mass major public health dissemination impact  Sharp Hazards o needles, lancets, and broken glassware o All sharp objects must be disposed in puncture-resistant, leak-proof container with the biohazard symbol  Chemical Hazards o Chemical Spills and Exposure  When skin contact occurs, the best first aid is to flush the area with large amounts of water for at least 15 minutes, then seek medical attention o Chemical Handling  Acid should always be added to water to avoid the possibility of sudden splashing caused by the rapid generation of heat in some chemical reactions.  Wearing goggles and preparing reagents under a fume hood are recommended safety precautions.  Pipetting by mouth is unacceptable in the laboratory. o Chemical Hygiene Plan o Chemical Labeling  Hazardous chemicals should be labeled with a description of their particular hazard, such as poisonous, corrosive, flammable, explosive, teratogenic, or carcinogenic o Material Safety Data Sheets (MSDSs)  MSDS o Information contained i n an MSDS includes the following: 1. Physical and chemical characteristics 2. Fire and explosion potential 3. Reactivity potential 4. Health hazards and emergency first aid procedures 5. Methods for safe handling and disposal 6. Primary routes of entry 7. Exposure limits a n d carcinogenic potential  Radiation Hazards o Radio activity may be encountered in the clinical laboratory when procedures using radioisotopes are performed. o The amount of radio activity present in the clinical laboratory is very small and represents little danger; however, the effects of radiation are cumulative related to the amount of exposure. o The amount of radiation exposure is related to a combination of time, distance, and shielding. o This symbol must be displayed on the doors of all areas where radioactive material is present. o Exposure to radiation during pregnancy presents a danger to the fetus; personnel who are pregnant or think they may be should avoid areas with this symbol.  Electrical Hazards o Equipment should not be operated with wet hands. o Designated hospital personnel monitor electrical equipment closely; however, laboratory personnel should continually observe for any dangerous conditions, such as frayed cords and overloaded circuits, and report them to the supervisor. o Equipment that has become wet should be unplugged and allowed to dry completely before reusing. o Equipment also should be unplugged before cleaning. o Al electrical equipment must be grounded with three-pronged plugs. o When an accident involving electrical shock occurs, the electrical source must be removed immediately. o This must be done without touching the person or the equipment involved to avoid transferring the current. o Turning off the circuit breaker, unplugging the equipment, or moving the equipment using a nonconductive glass or wood object are safe procedures to follow. o The victim should receive immediate medical assistance following discontinuation of the electricity.  Fire/Explosive Hazards o Flammable chemicals should be stored in safety cabinets and explosion- proof refrigerators, and cylinders of compressed glass should be located away from heat and securely fastened to a stationary device to prevent accidental capsizing o Fire blankets may be present in the laboratory. o Persons with burning clothes should be wrapped in the blanket to smother the flames. o What will you do?  RACE  Rescue – rescue anyone in immediate danger  Alarm – activate the institutional fire alarm system  Contain – close all doors to potentially affected areas  Extinguish/Evacuate – attempt to extinguish the fire, if possible or evacuate, closing the door  Physical Hazards o General precautions to consider are to avoid running in rooms and hallways, watch for wet floors, bend the knees when lifting heavy objects, keep long hair pulled back, avoid dangling jewelry, and maintain a clean, organized work area. o Closed-toed shoes that provide maximum support are essential for safety and comfort.  Factors contributing to laboratory accidents o A poorly designed laboratory and overcrowding can increase t h e risk of accident occurrence. Most lab accidents are the result of bad lab practices like:  Poor training  Lack of concentration  Noisy environment  Untidy working and not using racks to hold sample containers  Hurrying to finish work  Allow the working bench to become cluttered  Carelessness and negligence  Over work and fatigue  Hot and humid climatic conditions  STANDARD PRECAUTIONS FOR INFECTION CONTROL o Handwashing  Wash after touching body fluids, after removing gloves, and between patient contacts. o Gloves  Wear Gloves before touching body fluids, mucous membranes, and non-intact skin. o Mask & Eye Protection or Face Shield  Protect eyes, nose, mouth during procedures that cause splashes or sprays of body fluids. o Linen  Handle linen soiled with body fluids so as to prevent personal contamination and transfer to other patients. o Occupational Health & Bloodborne Pathogens  Prevent injuries from needles, scalpels, and other sharp devices.  Never recap needles using both hands.  Place sharps in puncture-proof sharps containers.  Use Resuscitation Devices as an alternative to mouth-to-mouth resuscitation. o Patient Placement  Use a Private Room for a patient who. contaminates the environment.  "Body Fluids" include blood, secretions, and excretions.  Safe Use and Storage of Chemicals and Reagents o Flammable chemicals  ether, xylene, toluene, methanol, ethanol, other alcohol, glacial acetic acid, acetone, acetic anhydride, Alcoholic Romanovsky stains and acid alcohol solutions.  In a fireproof metal box at ground level, preferably in and outside cool and locked store (alternative: a container well lined with tin foil should be used  N.B: Only small quantities of flammable solvents should be kept on lab, benches and shelves.  Before opening a bottle containing a flammable solvent, check that there is no open flame such as that from a Bunsen burner.  Do not light match near flammable chemicals.  N.B: Never heat a flammable liquid over a Bunsen burner or lighted gas. o Corrosive chemicals  strong acids such as concentrated sulfuric acid, nitric acid, glacial acetic acid, trichloroacetic acid, ortho - phosphoric acid, and caustic alkalis such as sodium hydroxide (caustic soda) and potassium hydroxide (caustic potash)  stored at low level to avoid any serious injury, which could be caused if they are accidentally knocked off a shelf  Never mouth pipette corrosive chemicals  Always pour corrosive chemicals at below eye level, slowly and with great care to avoid splashing.   When opening a container of corrosive chemicals, and when pouring it, wear protective materials. o Toxic, harmful, and irritating chemicals  chemicals which can cause death or serious ill-health if swallowed or inhaled, or if the chemical is allowed to come into contact with the skin  Examples: potassium cyanide, sodium nitroprusside, formaldehyde solution, chloroform, barium chloride and methanol; iodine and sulphanilic acid chemicals can cause inflammation and irritation of the skin, mucous membranes, and respiratory tract  Highly toxic chemicals such as potassium cyanide must be kept in a locked cupboard.  Stock solutions or solids of harmful and irritating chemicals should be stored safely ni cap board, not on an open shelf.  Handle with great care by wearing protective gloves.  Always lock away highly toxic chemicals immediately after use.  Keep the lab, well ventilated while the chemicals are being used. o Oxidizing chemical  includes chlorates, perchlorates, strong peroxides, potassium dichromate, and chromic acid  must be stored away from organic materials and reducing agents  they can produce much heat when in contact with other chemical, especially flammable chemicals  Handle oxidizing chemicals with great care.  Most are dangerous to skin and eyes and when in contact with reducing o Explosive chemicals  Heat, flame, or friction can cause explosive chemicals to explode.  Example: picric acid (must be stored under water)  If picric acid is allowed to dry, it can become explosive.  This can occur if the chemical is left to dry in pipes without being flushed away with adequate amount of water. o Carcinogens  Any substance that has the potential to cause cancer in living tissues  Cause cancer by ingestion, inhalation, or by skin contact (ex.: benzene, ortho - toluidine, alpha and beta -naphthylamine, nitrosamines and selenite)  Should be kept in closed containers and labeled as 'carcinogenic, handle with special precautions  PreventiveMeasures o Adequate floor, bench and storage space for staff to work safely o Ample light is essential, especially in the examination areas of the laboratory o A sufficient supply of wall electric points to avoid the use of adapters o Overcrowding must be avoided o Good ventilation is essential with adequate provision of fume cupboards o There should be a system for marking "high risk" specimens o Discard containers that contain infectious microorganisms after each use o The floor should be well constructed with a surface that is non-slippery, impermeable to liquids and resistant to those chemicals used in the laboratory o Walls should be smooth, tree from cracks, impermeable to liquids and easily washable o Doors of the of the lab, should be opened to the out side direction o Sectioning of the lab, into separate rooms or working areas with definite places (for patients, visitors, and reception of specimens) o Bench surfaces should be without cracks, washable and resistant to the disinfectants and chemicals used in the laboratory o An adequate number of hand basins with running water is essential. o Provision of protective clothing o Fire extinguishers should be placed at accessible points. If extinguishers are not available several buckets of sand must be provided  o Ensure that all work in the laboratory is done with a safety conscious attitude o All staff must ensure that the conditions of their work do not create any hazard for those working near by o Laboratory coats should be fully buttoned up while working and removed before leaving the laboratory. o The chances of an accident occurring in the laboratory are much reduced if:  Every one works in a tidy fashion  Every one works with out rush  Benches are clean  Reagents returned to the shelves after each use  No eating, drinking or smoking in the laboratory. UNIT 5 WASTE MANAGEMENT Inquiry Stimulus o Waste Management: Video presentation o https://www.youtube.com/watch?v=r3VWT_WV56 o Inquiry questions: 1. What is the meaning of biomedical wastes? 2. What are the different types and classifications of biomedical wastes? 3. How those biomedical waste being disposed? 4. Why is biomedical waste management needed in a hospital? 5. Identify the different local regulatory agencies that facilitates proper medical waste disposal. 1. What is Health Care Wastes? o Refers to ALL solid or liquid wastes generated by any of the following activities:  Diagnosis, treatment, and immunization of humans;  Research pertaining to diagnosis, treatment, and immunization of humans;  Research using laboratory animals geared towards improvement of human health;  Production and testing of biological products; and  Other activities performed by a health care facility that generates wastes. o is a by-product of healthcare that includes sharps, non-sharps, blood, body parts, chemicals, pharmaceuticals, medical devices and radioactive materials. o Health Care Waste Generators are the ff:  Hospital and medical centers  Infirmaries  Birthing homes  Clinics and other health-related facilities  Laboratories and research centers  Drug manufacturers  Institutions (drug rehabilitation centers, etc.) o Categories of Health Care Waste: Waste Category Description Examples Refers to ALL wastes suspected to Discarded microbial cultures, 1 Infectious contain pathogens or toxins sputum cups, urine containers etc Refers to tissue sections and body fluids or organs derived from biopsies, 2 Pathological and Anatomical autopsies or SX (surgical) procedures sent to lab for examination Refers to waste items that can cause Syringes in phlebotomy, blood 3 Sharps cuts, pricks, or puncture wounds. Most lancets, broken glasswares dangerous HC waste Refers to discarded chemicals 4 Chemical Waste generated during disinfection and Acids, bases, metals etc sterilization procedures Refers to expired, spilt and Empty drug vials, medicine bottles, 5 Pharmaceutical Waste contaminated pharmaceutical products, syringes, needles and vials drugs, vaccines etc. Wastes exposed to radionucleotides Wastes contaminated with ionizing 6 Radioactive Waste including radioactive diagnostic radiation such as cobalt, iodine and materials. iridium Non-hazardous or General Refers to wastes that do not pose a 7 Paper products, woods etc. Waste hazard o IMPACTS OF HEALTH CARE WASTES:  Individuals exposed to health care wastes such as medical staff, in- and out-patients etc are potentially at risk of being injured or infected.  Other potential hazard may include drug-resistant microorganisms that can spread from health facilities into the environment.   Incinerating waste also causes problems, because plastics tend to produce toxic substances, such as dioxins, when they are burnt. Gases from incineration may cause air pollution and contribute to acid rain, while the ash from incinerators may contain heavy metals and other toxins. o IMPROPER WASTE DISPOSAL  Improper waste disposal is the disposal of waste in a way that has negative consequences for the environment. Examples include littering, hazardous waste that is dumped into the ground, and not recycling items that should be recycled. 2. Legislation, Policies, and Guidelines Governing Health Care Wastes o International Agreements pertaining to health care waste management  The Montreal Protocol on Substances that Deplete the Ozone Layer (1987)  The Basel Convention on the Control of the Transboundary Movements of Hazardous WSTES AND Their Disposal (1989)  The United Nations Framework Convention on Climate Change (1992)  The Stockholm Convention on Persistent Organic Pollutants (2001)  The ASEAN Framework Agreement on the Facilitation of Goods in Transit (1998). 3. Health Care Waste Management o Health Care Waste Management Hierarchy o Minimization  Refers to approaches adopted by the health facility to reduce the amount of HCW generated during delivery of services. It includes strategies to reduce unnecessary injections, as well as to recycle or reuse some of the materials. o Segregation  Refers to placing HCW into separate containers according to type: non-infectious or general waste, infectious, highly infectious, and sharps waste. o Handling and storage  Refers to steps taken to manage waste during containment and storage whilst waiting for collection or transportation to a treatment plant or disposal site. o Collection and transport  Refers to an organized system for removing waste from the point of health facility or temporary storage to a treatment or disposal site. Waste may be transported within the health facility or to an offsite treatment plant and disposal site. o Treatment  Refers to rendering HCW safe for handling and final disposal.  Some of the methods used include:  Incineration – burning at high temperatures in an incinerator – 850°C to 1100°C (Demontfort 600°C to 700°C)  Sterilization – using autoclave or microwave technology  Chemical disinfection – Treatment methods using a chemical such as hypochlorite solution (jik) to render the waste safe.  Shredding waste – using mechanical grinders to break it down into unrecognizable pieces. This method does not treat infectious waste and should be used in conjunction with sterilization.  Macerators – for anatomical waste fall in this category o f treatment.  Disposal – refers to the final discharge of waste and residues or by-product from the treatment of waste. o Segregation Categories  Health care workers should segregate HCW immediately at the point of generation according to the type of waste. The national HCW segregation chart has the following categories:  General or non-infectious waste  Infectious waste  Highly infectious or anatomical/pathological waste  Sharps waste   Individual health facilities may include other categories in addition to the above, such as food remains, bottles, etc. This can promote recycling or reuse of materials that may have potential value for resale. o Categories of Health Care Waste o Color Coding for Waste Segregation in Health Care Facilities  o Universally Accepted Hazard Symbols o Sharps Waste Management  Sharp waste must be immediately contained after use in order to prevent injury.  The primary way to contain sharps is by using safety boxes and needle removers when available in the health facility.  A safety box is a puncture- and leak- resistant container for disposal of sharps.  Remember!  Health care workers should segregate waste at point of generation.  Waste should NEVER be re-sorted.  Seal all waste containers and label them to describe contents. o Handling and Storage of Health Care Waste  Handling of Health Care Waste  Handling is the process of packing and moving waste materials at the points of generation. It is done by generators and handlers of waste as ti entails holding pieces of waste in bins located near the points of waste generation.  In general, the following measures should be taken when handling HCW:  Health workers handling waste must wear appropriate personal protective equipment (PPE) when handling waste.  Sharps must always be placed in injection safety boxes and never be placed in waste bags.  Waste must be contained in color-coded and well-labelled plastic bags.  Waste bags must not be overfilled (fill to approximately three-quarters of capacity).  The volume of waste bag should not exceed 55 liters.  At the point of waste generation, excess air should be expelled from the bag without compacting the contents, prior to closure using a bag tie.  All bags should be held away from the body by the closed top of the bag, and placed directly into a mobile garbage bin or trolley.  Where waste bags are sealed and stored pending collection, they should be in a secure place with restricted access.   A waste collection schedule should be in place.  Storage of Health Care Waste  Storage is the temporary containment of waste in a secured area before collection for treatment and/or disposal. Storage requirement must meet the criteria set by technically trained personnel.  The storage time must not exceed 24 hours.  Any storage if waste, including sharps, before treatment or collection for offsite disposal should be in a secure location designated for the purpose.  Recommendation for the transfer station/storage area and its equipment:  There should be a water supply for cleaning purposes.  The area should be clearly demarcated and have a sign warning trespasser.  The storage area should have impermeable, hard-standing floor with good drainage; it should be easy to clean and disinfect.  The storage area should afford easy access for staff in charge of handling waste.  It should be possible to lock the storage area to prevent access by unauthorized.  Easy access is required for waste-collection vehicles.  The area should have protection from the sun.  The storage area should e inaccessible to animals, insects, and  There should be good lighting and ventilation (passive ventilation at a minimum). o Collection and Transportation of Health Care Waste  Collection of health care waste  Collection is the assembly of waste packages from different sections to one point. Collection is meant to avoid accumulation and decomposition of waste in an area.  Guiding principles in collection of waste include:  Remove waste liner bags from the service point and take them to a storage or disposal area.  Waste should sot be allowed to accumulate at the point of production. For this reason, a routine schedule for waste collection should be established as part of the HCWM plan.  Health care workers should ensure that waste liner bags are tightly closed or scaled when they are about three-quarters full.  Light-gauge liner bugs can be closed by tying the nock, but heavier-gauge bags probably require a plastic scaling tag of the self-locking type.  Liner bags should not be stapled closed. o Transportation of Health Care Waste  Transportation refers to moving collected wastes from temporary storage area to treatment or disposal site. HCW can be transported to a treatment site within the hospital (known as "onsite") or outside (known as "offsite").  When moving waste from one place to another-either onsite or offsite-the following precautions should be taken:  Boxes of waste must be kept upright; avoid direct contact of safety boxes with other waste or medical supplies in the same vehicle.  Safety boxes must be kept dry.  Waste should be placed in collection points at ensure that he waste handlers do not enter the wards/departments as they move en route.  Health facilities should have a clearly defined route for transportation of waste.  The transport routes should avoid food preparation and heavily used areas.  After transport, decontaminate and clean vehicle surfaces.  HCW should be transported in designated vessels only. 4. Treatment and Disposal of Health Care Wastes o Treatment of Health Care Waste  Treatment is the process of rendering HCW safe by reduction or elimination of the potential to cause harm and reduction of the volume. HCW should be treated prior to disposal to ensure protection from potential hazards posed by the waste. To be effective, treatment must reduce or eliminate the risk present in the waste os that ti no longer poses hazard to persons who may be exposed to it.   The common methods of treatment are incineration, steam sterilization, chemical disinfection, autoclaving, and microwave irradiation. Other methods that can be used include encapsulation and inertization, shredding, and placenta maceration.  Laboratory infectious products must be pre-treated at the point of generation as per the National Biosafety and Biosecurity Guidelines.  Pyrolysis  is a thermochemical treatment, which can be applied to any organic (carbon- based) product. In this treatment, material is exposed to high temperature, and in the absence of oxygen goes through chemical and physical separation into different molecules (either gaseous, liquid or solid form).  Autoclave  The method of using pressure and heat is widely used and usual setting is at 121 deg C with a pressure of 15 psi for 15 to 30 mins.  Microwave  Waste is exposed to microwaves that raise the temperature to 100 deg C for at least 30 minutes.  Chemical Disinfection  Disinfection by the used of chemicals. It is recommended that 5% sodium hypochlorite (bleach) be used for chemical disinfection.  Biological Process  Uses an enzyme mixture to decontaminate health care wastes. This is suited for large applications and is also being developed for possible use in the agricultural sector.  Encapsulation  Involves the filling of containers with waste, adding and immobilizing material, and sealing the containers.  Inertization  Suitable for pharmaceutical waste that involves the mixing of waste with cement and other substances before disposal. UNIT 6: RISK MANAGEMENT IN THE CLINICAL LABORATORY Risk Management o A hazard is any source of potential damage, harm or adverse health effects on something or someone. o An exposure is the probability and/or amount of contact between the hazard and the entity it is potentially harming. o A risk is the chance or probability that a person will be harmed or experience an adverse health effect if exposed to a hazard. It may also apply to situations with property or equipment loss, or harmful effects on the environment. o Risk Science  Risk Assessment (Risk Evaluation)  A systematic approach to identify hazards, evaluate risk and incorporate appropriate measures to manage and mitigate risk for any work process or activity.  Risk Communication  An essential part of shared decision making and evidence-based patient choice.  Risk Perception   Highly personal process of decision making, based on an individual’s frame of reference developed over a lifetime, among many other factors.  Risk Management  Is a systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk (ISO 14971)  Can be based on several consensus guidelines or accreditation agencies:  ISO15189  CLSIEP18, EP 23  CAP(CollegeofAmericanPathologists) o The objective of risk management is to reduce different risks related to an act or a failure to act to a level acceptable to the facility. o Risk Management in Healthcare  An approach in which a specialist addresses the prevention and containment of liability by documenting critical or unusual incidents towards the patient or healthcare worker.  TowardsPatientSafety  TowardsLaboratorySafety o Risk management is not a new concept; laboratories:  Evaluate the performance of new devices.  Troubleshoot instrument problems.  Respond to physician complaints.  Estimate harm to a patient from incorrect results.  Take actions to prevent errors. o Risk management is a formal term for what clinical laboratories are already doing every day. o Risk management attempts to answer the following:  What can go wrong (process mapping, brainstorming)  How bad is it? (severity of harm, especially with downstream events)  How often (probability of occurrence for potential errors, frequency of occurrence for observed errors)  What should be done to mitigate/reduce the risk? ( o Risk Management Process  Managing risks is not only a process, but a mindset that needs to be present throughout the laboratory. Laboratories need to create a risk management culture.  Risk management can be:  a project triggered by an occurrence or finding,  a proactive project to evaluate potential weaknesses in a new, revised, or complex processes or  a continuous assessment based on daily events and observation of what is happening in the laboratory.prioritization of risks)  Stages: 1. Analyze the laboratory process o Risk identification o Understand the lab process (typically through process mapping) and identify risk points. o Laboratory work processes include more than lab tests.  Core processes from the pre-analytical, analytical and post-analytical phases.  Support processes such as document control and procurement.  o Tools to help laboratorians perform risk identification. 1. Process mapping  A process map is a graphical representation of all the steps in a testing process. 2. Fishbone diagram  A fish bone diagram outlines the cause and effect of a testing process. 3. Risk identification table  A risk identification table is a simple table that lists all the errors identified in the different testing phases for a specific test. o Developing a process map:  Break down all phases of the test or test system into steps, so that weak points can be identified.  Each step can be analyzed to find potential failure modes that could present significant risk to patients.  Process can then be further analyzed to see if controls can be put into place to avoid the failures. o Risk Identification Table 2. Evaluate risk points o Risk Assessment o Assess them based on probability and severity/impact. o Typically this takes the form of a matrix and assigning a value to the risk. o Risk Matrix Example  Note: Many laboratories find it helpful to provide further definition of the increments of probability and severity/impact. See Appendix A for an example of a scale of probability and severity/impact. o Sources of Errors  Environmental  Temperature  Humidity  Light intensity  Altitude  Operator  Improper specimen preparation, handling  Incorrect test interpretation  Failure to follow test system instructions  Specimen  Bubbles  Clots  Incorrect tube additive  Analysis  Calibration factor incorrect  Mechanical failure o Information gathering  Regulatory and accreditation requirements   Clinical Laboratory Improvement Amendments Test/test system information  User’s manual, reagent package inserts, literature.  Healthcare and testing site settings  Temperature conditions, operator training programs  Medical requirements for the test results  Allowable performance specifications via physicians o Information gathering  Evaluating complaints from patients and clients  Reviewing incident reports – root cause analysis  Evaluating deficiencies cited by accreditation or governmental inspec