MLS 037 Summative Exam Notes PDF

MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM VIVIAN Traces the beginning of...

MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM VIVIAN Traces the beginning of HERRICK Medical Technology when 1500 B.C intestinal parasites such as Taenia and Ascaris were mentioned in early writing. Ebers Papyrus - book containing the description A Clinical laboratory science related to the prevention, diagnosis, of the three stages of and treatment of disease hookworm infection MEDICAL LABORATORY SCIENTISTS RUTH She believed that Medical Detectives Perform Routine and Complex Analyses WILLIAMS Technology began from the Responsible in the accuracy of results 1096 - 1438 Medieval period, supported Correlate interdependent Test Results by the fact that urinalysis Can Supervise and Teach was a fad. Early Hindu Doctors - made Heinemann Application of principles of natural, a scientific observation that physical, and biological sciences to the the urine of certain performances of laboratory procedures individuals attracted ants which aid in the diagnosis and treatment and that such urine had a of diseases sweet taste ANNE The branch of medicine concerned with the performance of laboratory ANNE She preferred to date FAGELSON FAGELSON 14th Medical Technology from determinations and analyses used in the diagnosis and treatment of diseases and CENTURY the 14th Century maintenance of health Alessandra Giliani - PHILIPPINE An auxiliary branch of laboratory employed to perform tasks medicine which deals with the under the domain of MEDICAL examination by various chemical, Medical Technology by a TECHNOLOGY microscopic, bacteriologic, and other prominent Italian physician ACT OF 1969 medical procedures, technique which will at the University of Bologna aid the physician in the diagnosis, study and treatment of disease and in the but died from a laboratory promotion of health in general acquired infection. MALPIGHI He was described as the 1628 – 1694 greatest of the early microscopists. His work in embryology and anatomy marked him as HIPPOCRATES Regarded as the founder of the founder of pathology. 460 B.C scientific medicine. ANTON VAN He invented and improved He determined the LEEUWENHOEK the compound microscope. correlation between 1632 - 1723 He was the first to describe anatomical and chemical red blood cells, to see laboratory findings and the protozoan, and to classify causes of diseases. bacteria according to He adopted the triad of shape. It led to the rapid regimen in treating progress of microbiology diseases and infection with and pathology the use of drugs, surgery, and bloodletting 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 1 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM FEHLING He performed the first quantitative 1848 test for urine. ANILINE DYES Aniline dyes, for staining 26TH MEDICAL INFANTRY OF THE US ARMY WERE microorganisms were Introduced Medical Technology practice in the PRODUCED produced about the middle Philippines at the end of World War II. 15th CENTURY 15th century. They established the first clinical laboratory in the Bacterial staining and Philippines at Quiracada St., Sta. Cruz, Manila microscopic study on where the Manila Public Health Laboratory is bacteria were made presently located. possible. They left the clinical laboratory in June 1943 and endorsed it to the National Department of Health. DR. PIO DE RODA Realized the need for clinical laboratories in the DR. DOUGLAS Philippines. Established the first chemical laboratory at the He formally organized the Manila Public Health University of Michigan Laboratory from the remnants of the deserted DR. WILLIAM WELCH laboratory. Gave the first laboratory course in pathology. He He was assisted by Dr. Mariano Icasiano, who was became the first professor of pathology at John then the Manila City Health Officer, on October 1, Hopkins University in 1885. 1945. DR. WILLIAM OSLER In 1947, he revived the training of high school Opened the first clinical laboratory at John graduates to work as medical technicians Hopkins Hospital in 1896. Search for Malarial together with Dr. Prudencio Sta. Ana. No definite parasites in the blood were given special attention period and no certificates were given to the DR. JAMES TODD trainees. Wrote the book “A Manual of Clinical Diagnosis in In 1954, a six-month laboratory training with 1908 and was re-titled” Clinical Diagnosis by certificate upon completion was given to the Laboratory Methods by Dr. Todd and Dr. Sanford trainees. Dr. Sta. Ana prepared the syllabus. The two doctors were helped by Dr. Tirso Briones WORD WAR I an important factor in the growth of clinical laboratory and produced a great demand for technicians MRS. WILLA HILGERT-HEDRICK 1923 The founder of Medical Technology Education in University of Minnesota was the first to offer the Philippines. degree level program DR. JESSE UMALI 1931 The first graduate of Philippines Union College, the Denver Society of Clinical Pathologist was first school to offer BS Medical Technology, now organized Adventist University of the Philippines. A 1936 successful OB-Gynecologist American Board of Pathology was established WORLD WAR II 1957 - 1958 Dr. Antonio Gabriel and Dr. The use of blood increased and the closed system Gustavo Reyes of the of blood collection was widely used. Faculty of Pharmacology, University of Sto. Tomas 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 2 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM Medical Technologist is trained much more offered MT as an elective to extensively in the theory of the various MT 4th and 5th year students. disciplines. CANADA Rev. Fr. Lorenzo Rodriguez Three-year college programs are offered that decided to offer it as a include seven semesters, in which two comprised course. an unpaid internship JUNE 17, 1957 A temporary permit was The student graduates before taking a standard issued by the Department examination (such as the Canadian Society for of Education for the first to Medical Laboratory Science, or CSMLS exam) to third year students. be qualified as a medical laboratory technologist JUNE 1960 Permit for the internship program was issued. CLINICAL CHEMISTRY The full recognition of the HEMATOLOGY JUNE 14, 1961 4- year BS Medical MICROBIOLOGY Technology course PARASITOLOGY IMMUNOSEROLOGY BLOOD BANKING CLINICAL MICROSCOPY HISTOPATHOLOGY BACHELOR OF SCIENCE IN MEDICAL TECHNOLOGY A four-year degree program wherein the students Certification examination created by PRC attend classroom for three (3) years and does (Professional Regulation Commission) clinical rotations for one (1) year A candidate must obtain a general average of at Clinical Internship program: 40hrs per week for least 75% in the written test, with no rating lower 52 weeks (or one full year) than 50% in any of the major subjects, provided Teach on how to collect, preserve and analyze that the candidate has not failed in at least 60% of specimens such as blood, urine, cells and tissues the subjects computed according to their relative as well as the preparation of reagents and stains weights Train on how to use modern equipment, In the Philippines, Medical Technology graduates instruments and scientific methods to provide who will pass the Philippines Board of Medical accurate laboratory results Technology are entitled to use RMT (Registered CALIFORNIA Medical Technologist) after their name. their One-year degree and students are required to relative weights. take courses in clinical chemistry, transfusion OTHER CERTIFYING AGENCIES services, phlebotomy, medical microbiology, American Medical Technologist in Rosemont, hematology and coagulation Illinois Graduates are prepared to take California State National Healthcare Association Licensing Examination and certification National Phlebotomy Association examination through American Society of Clinical National Center for Competency Testing Pathology Accrediting Bureau of Health Education Schools UNITED STATES Two-year qualifies the graduate to work as a medical laboratory technician (MLT). 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 3 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM QUALIFICATION FOR EXAMINATION PROFESSIONAL ORGANIZATIONS 1. Good Moral Character PHILIPPINE PAMET 2. Good Health ASSOCIATION OF 3. Has completed a course at least four years leading to the degree of science in medical MEDICAL technology by a recognized school, college or TECHNOLOGIST university PHILIPPINE PASMETH SCOPE OF EXAMINATION ASSOCIATION OF 1. Clinical Chemistry (20%) SCHOOLS OF 2. Hematology (20%) MEDICAL 3. Immunology and Serology/Blood Banking (20%) TECHNOLOGY AND 4. Microbiology [Bacteriology, Parasitology, and PUBLIC HEALTH Mycology and Virology] (20%) LOCAL COUNCIL OF 5. Urinalysis and other Body Fluids (10%) PROFESSIONAL 6. Histopathology, MT Laws and Bioethics (10%) PROFESSIONAL ASSOCIATIONS HEALTH ASSOCIATIONS PHILIPPINE FEDERATION OF SPECIFIC PROFESSIONS, CAREERS, OCCUPATIONS PROFESSIONAL FOR GRADUATES ASSOCIATIONS Licensed Medical Technologists/Medical COUNCIL OF HEALTH Laboratory Scientists AGENCIES Diagnostic Molecular Scientists PHILIPPINE COUNCIL Research Scientists FOR Educators QUALITYASSURANCE Diagnostic Product Specialists IN CLINICAL Public Health Practitioners LABORATORIES Healthcare Leaders INTERNATIONAL ASEAN AN MT/MLS GRADUATE MAY PRACTICE IN THE PROFESSIONAL ASSOCIATION OF FOLLOWING FIELDS: ASSOCIATIONS CLINICAL Public Health/Epidemiology LABORATORY Veterinary Laboratory Science SCIENCES Molecular Biology/Biology ASIA ASSOCIATION Nuclear Science OF MEDICAL Forensic Science LABORATORY Health Administration/Management SCIENTISTS Food and Industrial Microbiology INTERNATIONAL FEDERATION OF BIOMEDICAL LABORATORY There is a steady demand for Medical Technologist SCIENTISTS overseas ASIA-PACIFIC Requires one to take their licensure examination as FEDERATION OF well as required trainings. CLINICAL Requires to have an experience of 2 years or more. BIOCHEMISTRY 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 4 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM o Blood banking o Microbiology o Immunology and Serology o Hematology In the Philippines o Serology Registered Medical Technologist with 1 to 4 years o Parasitology of experience receive a monthly salary ranging o Clinical Microscopy from P10, 000 to P20, 000 per month. o Toxicology o Therapeutic drug monitoring Abroad o Endocrinology In industrialized countries, pay is definitely higher Concerned with the diagnosis and than local rates. Salary in the USA ranges from treatment of disease through laboratory $50, 000 to $70, 000 per year. testing of blood and other body fluids. 2. Anatomic Pathology Focuses on areas of: o Histopathology o Immunohistopathology o Cytology A clinical laboratory is a place where specimens o Autopsy from the human body may be collected, o Surgical Pathology processed, examined or analyzed o Forensic Pathology Its main task is to provide accurate information to Concerned with the diagnosis and doctors for diagnosis, prognosis and treatment of treatment of disease through disease microscopic examination of tissues and Actively involved in research, infection control, organs information evaluation and innovative diagnostic technologies. PURPOSE To provide physicians and health care professional with 1. Institution-based information: Operates within the premises of an ❖ detect disease or predisposition to disease institution such as ❖ confirm or reject a diagnosis o Hospital ❖ establish prognosis o School ❖ Guide patient management o Medical Clinic ❖ Monitor efficacy of therapy o Medical facility for overseas workers and seafarers CLASSIFICATION o Birthing home ❖ According to function o Psychiatric facility ❖ According to Institutional Characteristics o Drug Rehabilitation center ❖ According to Ownership Hospital-based laboratory is the most ❖ According of Service Capability common example 2. Free-standing Not part of an established institution Free-standing out-patient clinical 1. Clinical pathology laboratory is the most common example Focuses on the areas of: o Clinical Chemistry 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 5 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM ▪ Gram Staining (if hospital-based) 1. Government-owned Equipment requirements are but not Owned wholly or partially, by national or limited to microscopes, centrifuge, HCT local government units centrifuge o Clinical and anatomical Space requirement is at least 10 square laboratories of DOH-run meters government hospitals 2. Secondary Category ▪ San Lazaro Hospital Licensed to perform tests done by ▪ Jose R. Reyes Memorial PRIMARY LABORATORIES along with Medical Center o Clinical Chemistry ▪ University of the 1. Blood Glucose Philippines-Philippine Concentration General Hospital 2. Blood Urea Nitrogen o Local government-run hospital- 3. Blood Uric Acid based clinical laboratories 4. Blood Creatinine ▪ Ospital ng Maynila Medical Center 5. Cholesterol ▪ Sta. Ana Hospital Determination ▪ Bulacan Medical Center 6. Total protein Mass 2. Privately-owned Concentration Owned, established, and operated by an o Microbiology (if Hospital-based) individual, corporation, institution, 1. Gram Stain association, or organization 2. KOH Mount o St. Luke’s Medical Center o Blood bank (if Hospital-based) o Makati Medical Center 1. Crossmatching o MCU-FDTMF Hospital Minimum equipment requirements are 1 microscope, 2 centrifuge, 3 hematocrit centrifuge, 4 semi-automated analyzers, 5 autoclave, 6 incubator, and 7 oven. 1. Primary Category Space requirement is at least 20 square Licensed to perform basic, routine meters laboratory testing such as 3. Tertiary Category o Routine Urinalysis Licensed to perform all the laboratory o Routine Fecalysis tests done by SECONDARY LABORATORY o Routine Hematology along with ▪ Complete Blood Count o Immunology and Serology 1. Hemoglobin 1. NS1-Ag for Dengue 2. Hematocrit o Microbiology, Bacteriology & 3. WBC count Mycology 4. RBC count 1. Differential Staining 5. WBC 2. Culture and differential Identification of count bacteria and fungi 6. Qualitative 3. Antimicrobial platelet count Susceptibility testing ▪ Blood Typing o Special Clinical Chemistry 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 6 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM San Lazaro HIV and other STDs 1. Clinical Enzymology Hospital 2. Therapeutic drug (SACCL) monitoring East Avenue For Environmental and occupational 3. Makers for certain Medical Center health; toxicology and micronutrient diseases assay o Special Hematology National Kidney Hematology inc. 1. Bone marrow studies and Transplant Immunohematology and 2. Special staining for Institute Immunopathology and Anatomic abnormal blood cells Pathology 3. Red cell morphology Philippine Heart Pathology for Cardiac Disease o Immunohematology and Blood Center Banking 1. Blood donation Lung cancer of Atomic pathology for pulmonary program the Philippines disease 2. Antibody screening Research Dengue, Influenza, TB, and other 3. Identification and Institute for Mycobacteria, Malaria and other Preparation of blood Tropical parasites, Bacterial enteric disease. components Medicine Measles and other viral exanthems, Equipment requirements include those Mycology, Enteroviruses, seen in secondary laboratories along with Antimicrobial resistance and 1 Automated Chemistry Analyzer, 2 engineering disease Biosafety cabinet class II, and 3 Serofuge. Space requirement is at least 60 square meters 4. National Reference Laboratory A laboratory in a government hospital designated by the DOH to provide special diagnostic functions and services for certain diseases Functions include REPUBLIC ACT NO. 4688: Clinical o referral services o provision of confirmatory Laboratory Act of 1966 testing Act regulating the operation and maintenance of o Assistance for research clinical laboratories and requiring the registration activities of the same with the department of health, o Implementation of External providing penalty for the violation thereof, and for Quality Assurance Programs other purposes. (EQAP) Approved on June 18, 1966 o Resolution of conflicts regarding PURPOSE test results of different To protect and promote the health of the laboratories people by ensuring availability of clinical o Training of Medical laboratories that are properly managed Technologists on certain with adequate resources, with effective specialized procedures and efficient performance through compliance with quality standard 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 7 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM Any person who operates a clinical laboratory ADMINISTRATIVE ORDER NO. 59 s. 2001 without proper license from DOH shall upon conviction be subject to imprisonment for not less “Rules and Regulations Governing the than 1 month but not more than 1 year OR a fine Establishment, Operation and Maintenance of no less than P1000 and not more than P5000 of Clinical Laboratories in the Philippines” or both at the discretion of the court Created to implement R.A. 4688 SECTION 7: Requirements and Procedures for Application of Permit to Construct and License to Operate STAFFING Application for permit to construct HEAD o Letter of Application to the BHFS Director Managed by a licensed physician certified by the o Four sets of Site Development Plans and Philippine Board of Pathology Floor Plans approved by an architect If pathologists are not available, a Physician with 3 and/or engineer months training on Clinical Laboratory Medicine, o DTI/SEC Registration (for private clinical Quality Control and Laboratory Management may laboratory manage a PRIMARY and SECONDARY laboratory Application for new license A Certified Pathologist may be authorized to o Duly notarized form “Petition to manage or supervised in not more than 4 Clinical Establish, Operate, and Maintain a laboratories/Blood banks. Clinical Laboratory” filed at the BHFS Application for renewal of license PERSONNEL o Duly notarized form “Application for Shall have sufficient number of Medical Renewal of License to Establish, Operate Technologies proportional to the workload and be and Maintain a Clinical Laboratory” filed available at all times during hours of operation. at respective CHD In hospital-based laboratory, there shall be at o Shall be filed 90 days before the expiry least (1) Medical Technologist per shift to cover of license the operation. PHYSICAL FACILITIES SECTION 8: Violations 1. It should be well-ventilated, adequately lighted, Operation of a laboratory without a certified safe and clean pathologist or without a registered medical 2. The space shall accommodate its activities and technologist allow for smooth workflow. Change of ownership, location, head of laboratory 3. The place to work in shall have an adequate without informing the BHFS and/or CHD water supply Refusal to allow inspection of laboratory 4. Shall have the following measurements: Gross negligence and any act or omission detrimental to the public SECTION 9: Investigation of Charges or Complaints Any person found violating the provisions of RA 4688, shall suspend, cancel or revoke for a determined period of time the license, as well as authority of the offending person/s. 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 8 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM Any refusal to participate in an EQAP given by NRL shall be one of the bases for EQUIPMENT / INSTRUMENT suspension/ revocation of the license of the PRIMARY SECONDARY TERTIARY laboratory Clinical centrifuge All those in 1 ̊plus All those in 2 the ff: ̊plus the ff: Hemacytometer Refrigerator Incubator Microhematocrit Photometer or Balance CLINICAL CHEMISTRY centrifuge equivalent Testing blood and other body fluids to quantify Microscope w/ oil Water bath or Rotator essential soluble chemicals such as waste equivalent products Hemoglobinometer Timer or Serofuge or Urine and Blood are the 2 most common fluids or equivalent equivalent equivalent One of the busiest sections, state-of-the-art, fully Differential counter Autoclave automated facility or equivalent Examples of tests performed: Drying oven 1. Fasting Blood Sugar (FBS) Biosafety 2. Glycosylated Hemoglobin (HbA1c) – cabinet diagnosis of diabetes (BSC) or 3. HDL and LDL equivalent 4. Triglycerides (TAG) – diagnosis of cardiovascular diseases 5. Uric Acid (BUA) QUALITY CONTROL PROGRAM 6. Blood Urea Nitrogen (BUN) INTERNAL QUALITY CONTROL PROGRAM 7. Creatinine There shall be a documented, continuous 8. Total Protein (TP) competency assessment program for all MICROBIOLOGY laboratory personnel Subdivided into four sections: The program shall provide appropriate and 1. Bacteriology – culture (c/s), gram standard laboratory methods, reagents and staining (g/s), KOH equipment 2. Mycobacteriology – fungal sensitivity and culture There shall be a program for the proper 3. Mycology – fungi identification only maintenance and monitoring of all 4. Virology – virus identification equipment Identification of bacteria and fungi on specimens The program shall provide for the use of received (usually blood and other fluids, stool, quality control reference materials tissues, and swabs from different sites in the body EXTERNAL QUALITY CONTROL PROGRAM HEMATOLOGY All laboratories shall participate in an Enumeration of cells in the blood and other body External Quality Assurance Program given fluids (e.g., CSF, pleural fluid, etc.) by National Reference Laboratories and Examinations done: other reference laboratories 1. CBC A satisfactory performance rating given by a 2. Hemoglobin National Reference Laboratory shall be one 3. Hematocrit 4. WBC differential count of the criteria for the renewal of license 5. Red cell morphology and cell indices 6. Quantitative platelet count 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 9 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM Useful in diagnosis of some types of cancers and certain neurodegenerative disorders, and assessment of 7. Total cell count and differential count patients’ responses to cancer therapy 8. Blood smear preparation MOLECULAR BIOLOGY AND 9. Staining for other fluids BIOTECHNOLOGY PARASITOLOGY One of the exciting developments in medical IMMUNOLOGY & SEROLOGY technology Analyses of serum antibodies in certain infectious DNA & RNA identification and detection of any agents (primarily viral agents) pathologic conditions/disease (enzymes and Antigen and antibodies testing reagent are used) Antibody screening tests: Polymerase chain reaction (PCR) – most common 1. Hepatitis B profile tests technique currently in use 2. Serological tests for syphilis 3. Hepatitis C tests 4. Dengue fever Encompasses all activities starting from a BLOOD BANKING medical doctor writing a laboratory request Blood typing and compatibility testing are the two up to the time (turn-around time [TAT]) the main activities results are generated for treatment and The most critical section in the clinical laboratory management of patients. because faulty cross-matching may cause Medical technologists should have a clear patient’s death understanding of the testing cycle to prevent Other tests performed: erroneous test results 1. 1.Antibodies screening and identification, Has three phases: pre-analytic, analytic, and blood components for transfusion. post-analytic 2. If hospital-based laboratories: - donor recruitment and PRE- ANALYTICAL POST- screening bleeding of donor, ANALYTICAL PHASE ANALYTICAL post-donation care PHASE PHASE CLINICAL MICROSCOPY Laboratory Test Equipment and Data Two major areas: Order / instruments Transmission 1. Routine and special examination of urine Requisition 2. Examination of stool (routine fecalysis) Order Reception Quality or Results ANATOMIC PATHOLOGY reagents used Application Histopathology & Cytology Patient Internal quality Turn-Around Tissue processing Preparation control program Time (TAT) Cutting into sections Specimen Staining Collection Preparation of microscopic examination by a Specimen pathologist transport and SPECIALIZED SECTIONS Processing Immunochemistry Combines anatomical, clinical, and biochemical techniques where antibodies (monoclonal and polyclonal) bounded to enzymes and dyes are used to detect presence of antigens in tissue 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 10 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM DIRECTING Leading people what to do and seeing that they do it to the best of their ability. CONTROLLING Management – the implementation of processes Monitoring employee performance, comparing it necessary to keep an organization functioning properly with the goals, and taking corrective actions as needed. PLANNING Identifying goals and determining the best course of action required to achieve those goals. SUCCESSFUL LEADERSHIP PRINCIPLES 1. Listening 2. Enthusiasm 3. Awareness 4. Decisive 5. Equal 6. Reward 7. Shallow Mission/Vision 8. Hypocrite 9. Isolate 10. Positive Communication ORGANIZING EFFECTIVE MANAGEMENT Assigning responsibilities to the employees with 1. Time detailed skillsets needed to complete the task 2. Human 3. Financial ACCURACY AND RELIABILITY FOCUS ON PATIENT The patient is an important part of a laboratory. They need to be approached in the best way possible FOCUS ON STAFF It is the workforce that ensures feasibility of STAFFING processes and obtaining reliable results. The competency of staff is very important Hiring the right people, for the right positions to help the organization achieve its objectives MANAGEMENT Old French word ménagemnet – “the art of conducting, directing”. Latin from manu agree – “to lead by the hand” 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 11 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM Does the right thing Does things right Leading and directing all or part of an ISO STANDARDS organization through the use of human, financial The gold standard for medical laboratory, in and intellectual resources. particular, is ISO 15189:2007 Provides the “road to get there” ISO 15189:2007 defines the particular Characterizes the process of leading and directing requirements for quality management systems all or part of an organization, through the use of requirements specific to medical laboratories. 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, Organization chart should be drawn with the dedicated people, and task-oriented leaders to responsibilities at all levels clearly defined achieve these goals. Assigned of responsibility Four Primary Management Functions The management team is responsible for strategic 1. Planning planning and it should be based on the vison and 2. Prompt decision making goals set. 3. Organizing LABORATORY ORGANIZATIONAL CHART 4. Leading and controlling LEADERSHIP Provides the direction of where one (or an organization) is going. Four key leadership styles: supporting, directing, delegating, and coaching. Engage others to complete tasks in a timely and productive manner. Provides the direction of where one (or an organization) is going. A pattern of behaviors used to engage others to complete tasks in a timely and productive manner. Supportive Leader provides physical and personal resources so that an individual can accomplish his or her duties. Directive Leader presents rules, orders, or other A series of processes in motion set by defined instructions to the individual. measurements that will ensure the quality of the laboratory. Leader Manager Consist of 5 pillars Administrator Implement Organizer & developer Maintains control Risk taker Thinks short term Inspiration Asks how & when Thinks long term Watches bottom line Asks what and why Accepts status quo Challenges status quo A good soldier 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 12 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM The staff are the single most important asset in QUALITY POLICIES any laboratory A statement of the goals of the organization with The laboratory shall be directed by a person or respect to its Quality System Management persons who have executive accountability and the competence to assume responsibility for the QUALITY PROCEDURES services provided. The details of the QSM, including the specific processes, procedures and staff responsibilities SPECIFIC DUTIES: DIRECTOR Staff operates according to the regulatory WORK INSTRUCTIONS environment The actual instructions for performing tasks that Staff are adequate in number, competent, trained affect the quality standards of the organization appropriately and evaluated QUALITY RECORDS Staff operate in a safe environment Documents that demonstrate conformance to the Methods and instruments are validated and specified requirements verified CORRECTIVE ACTION REQUESTS Laboratory conforms to all internal quality Controlled documents that specify how problems procedures and enrolled in EQA program with the organization’s QSM are to be fixed. PRIMARY RESPONSIBILITIES OF DIRECTOR Interaction with users of laboratory Quality issues Future planning Education Research 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: o Quality management Time Management - Turnaround time of reports o Training and education Who is going to do what - roles should be defined and o Health and Safety responsibilities spelt out PERSONNEL MANAGEMENT Use of human resources - the management needs to Personnel management ensures that staff ensure adequate staffing contribute fully and effectively to the service while Management workflow - so that all processes are receiving fair and consistent treatment from supervised and monitored for quality performance laboratory management. Financial Resources Laboratory management shall ensure that Set benchmarks or standards - the team should have procedure(s) for personnel management include: a goal set that would achieve the necessary standards. No o Staff recruitment and selection compromises on quality will be allowed and benchmarking o Staff description and induction should be against the internationally accepted standards. o Job descriptions and contracts 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 13 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM Laboratory management shall establish a procedure(s) for controlling material that o Staff records includes: o Staff annual joint review o Identification and indexing o Staff meetings and communication o Security o Staff training and education o Retention o Grievance procedures and staff o Storage and retrieval disciplinary action o Disposal JOB DESCRIPTIONS & CONTRACTS PREMISES AND ENVIRONMENT Written job descriptions and contracts enable Management will be responsible for providing staff to know their duties, responsibilities and space ensuring client comfort and safety of clients rights and employees, without compromising on the All staff shall have contracts of employment which quality of the service provided are in compliance Privacy of the patient during blood collection Laboratory management shall ensure that all staff should be provided and the needs of patients with have job descriptions that include: disability should be considered o A job title Storage and disposal of dangerous materials shall o The location within the organization be those specified by relevant regulations o Accountability The premises shall have staff facilities that are o The main purpose of the job readily accessible and include: o The main duties and responsibilities o Sufficient toilet accommodation o A requirement for participation in staff o Shower facilities when required annual join review o Rest area o Basic catering facilities and access to a STAFF RECORDS supply of drinking water Maintenance of accurate staff records is an o A changing area and secure storage for essential part of personnel management personal effects Laboratory management shall ensure the o Storage for protective clothing confidentiality of staff record in accordance with o Safe and secure working arrangement local guidelines and national legislation HEALTH AND SAFETY STAFF TRAINING A health and safety statement, and procedures to Records shall be kept of all training and education implement it, are required to ensure a safe Laboratory management shall appoint a training environment in the laboratory for staff, patients officer and visitors. There shall be resources for training and Laboratory Management shall be responsible for: education, that includes: o Defining and implementing health and o Access to reference material and safety procedures information services o Ensuring that there is a safe working o Access to a conveniently situated quiet environment in accordance with current room for private study safety guidelines and legislation o Staff attendance at meetings and o Providing personal protective equipment conferences o Delegating day-to-day management of o Financial support health and safety to the appointed CONTROL OF CLINICAL MATERIAL health and safety officer Notice shall be taken of current legislation, regulations and guidelines. 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 14 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM Lower repair costs Lengthens instrument life Reduces interruption of service due to The proper procurement and management of breakdowns and failure equipment ensures that the laboratory can fulfill Increases safety for workers the needs and requirements Produces greater customer satisfaction Laboratory management shall ensure that the Selection and purchasing equipment is sufficient and appropriate to provide Installation the service Calibration and performance evaluation Laboratory management shall establish a Maintenance procedure(s) for the procurement and Troubleshooting management of equipment, that includes: Service and repair o Assessment and justification of need Retiring and disposing of equipment o Selection and acceptance o Training o Preventive maintenance, service and Unique laboratory identifying number repair Manufacturer’s equipment identification o Calibration and monitoring of the Manufacturer’s contact person instruments, reagents and analytical Date of receiving and putting into service systems Manufacturer’s instructions o Decontamination Instrument performance records o Record of instrument failure and Maintenance records subsequent corrective action Damage to, malfunction of, modifications to, and o Planned replacement and disposal repair of equipment o Adverse incident and vigilance reporting Needs analysis Performance characteristics Size and space availability Optimize workflow Costs Minimize handling Service back up Minimize costs Training Reduce Walking Complexity of equipment – how easy it is to Reduce work in progress operate Improve management visibility Special operational requirements e.g de-ionized Improve work environment water Improve inventory Management Emergency power and waste disposal Will reagents be provided free of charge for a limited time LABORATORY TESTING PROCESS Helps maintain high level of laboratory performance Reduces variation in test results Improves technologists’ confidence in results 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 15 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM LABORATORY DESIGN TASK MAPPING Benchtops must be impermeable material that is easily cleaned and disinfected Must be enough space for equipment, specimen holding and writing or computer area to hold Operating Procedure Manual Floors need to made of material that is easily cleaned Separated color-coded containers for hazardous and other wastes Ventilation including that of hoods Temperature control Stable electrical power Adequate space including that for circulation and storage of supplies Easily cleaned on a daily basis Availability of deionized or distilled water Availability of emergency power Avoidance of risk of cross-contamination of specimens Service activities, such as sterilization and Plan for 20 years glassware washing should be located close to Make sure that occupants of future space are where they are needed Molecular Pathology requires separate rooms for involved in its design DNA extraction and testing Use an open design allowing for proper relationships Fluorescent microscopy requires a dark room Have a flexible layout with movable furniture DNA gel photography requires a dark room Use lean principles LAYOUT Application of ergonomics Like activities should be grouped together Design should be done bearing in mind the flow of Service activities, as much as possible, should be specimens and information: From patient to – consolidated and located near where their processing area to – testing Area to – Post-testing products are used Area Distilled water and emergency power available Probable implementation of charges in where needed technology should be considered IMPLEMENTING Patients and testing should be separated as much Success of planning is in its implementation. Much as possible planning stays at the documentation stage and Phlebotomy area should be near entrance never sees the light of day Laboratory space, as much as possible, should be Implementation process needs to be defined and off-limits to everyone except technical and made and plan in achievable steps maintenance staff Management also has the responsibility to sustain Specimen preparation area should be between the implementation process and, collection and testing areas Management has the responsibility to direct Clean and dirty areas should be separated sufficient resources to enable the completion of the plan 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 16 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM establish that an act is right from wrong or distinguish a good act from a bad MONITORING one. Any process needs to be monitored and measured to see if: Plans have been accomplished as outlined Benchmarks and standards are met Bioethics is used interchangeably with medical Outcome should be a system that is continuously ethics. evolving and improving, thereby remaining Both are applied ethics. dynamic and sensitive to the clients’ needs. Bioethics is a combination of ethical theory and various disciplines such as medicine, law, social sciences, philosophy, and the like to address the ethical issues of clinical decision-making and medical research. Medical ethics deals with moral values and decisions as they are applied to medicine. Definition of Ethics Ethics is derived from the Ancient Greek word ethos which means the “theory of things” or “way of living”. Beneficence - the principle of doing an action that Ethics is also derived from the old French word benefits others. ethique; late Latin ethica which means “of or for Propositions coming from the act of morals, moral, or expressing character”; and beneficence include: (1) prevent the modern Latin mores which means “customs”. infliction of needless (unnecessary) pain; Ethics is considered as the fundamental concept (2) prevent killing a person; (3) prevent of what is meant as the decency of human incapacitating others. conduct. It covers the study of universal values, Non-Maleficence - the avoidance of doing harm existing individual and societal norms and values, to others. equality between men and women, human or Propositions associated with the natural rights, legal rights as mandated by execution of non-maleficence include: (1) fundamental laws, balance of nature, and do not cause needless pain; (2) do not concern and compassion for health and safety. kill; (3) do not incapacitate others. Types of Ethics Respect for Autonomy - the act of respecting the decision of others. META-ETHICS In medical technology laboratory seeks the use of ethical reasons for the things or services, respect for autonomy is events that have happened or have been operationalized into the so-called happening as the will of the Almighty God. It “informed consent”. literally means ethics far beyond the physical world, that is the rule of power and the will of Standard rules of full disclosure in order Almighty God over human reasoning. to satisfy informed consent: APPLIED ETHICS 1. Prudent person rule Ethics is applied in various fields and in real-life In this rule, the patient must situations. Various subdisciplines of applied ethics completely understand the have been created. They include environmental, diagnosis, nature, benefits, medical, social, and business ethics. known risk and consequence of NORMATIVE ETHICS the proposed treatment; the Bridges the gap between meta-ethics and applied rates of doctor’s and hospital’s ethics and attempts to 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 17 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM success and failure of the should have access to the same treatment; the complete things that might improve their information of the alternative health. treatment; the prognosis if no treatment is given; and all costs and burdens of the proposed PROFESSIONAL ETHICS treatment. Professional Ethics emanates from the moral 2. Subjective substantial reflection of professional endeavors enveloped in disclosure a code of ethics. This rule holds that every Healthcare Professionals such as doctors, nurses, information of the treatment engineers, biologists, including medical should be properly technologists are expected to act according to disseminated to the patient certain standards of behavior. after the patient has presented For instance, medical technologists are guided by his/her opinion, belief, norms , the Medical Technology Code of Ethics. and values. NO EXPLICIT CONSENT IS NEEDED IN CASES OF: Implied consent o where procedures are not risky and first published by the Philippine Association of invasive Medical Technologist (PAMET) in 1968 prior to the Therapeutic privilege approval of R.A. No. 5527 in 1969. o where information is really detrimental amendments to the Code of Ethics were to the patient’s condition or illness organized by the Board and Committee members Emergencies in consultation with the Accredited Professional o patient is incompetent and no surrogate Organization (APO) and other stakeholders from is available the academe, industry, and laboratory Justice - the application of legal ethics in medical practitioners. technology professional practices. 13 September 2022, the Professional Regulatory entails fairness, equality and impartiality Board of Medical Technology issued Resolution Two categories of Justice: No. 72 revising the Code of Ethics of the Medical o Distributive Justice - means Technology Profession. that individuals have the right to be treated equally regardless of ethnic group, culture, age, marital status, medical As I enter the practice of Medical Technology, I shall: diagnosis, social standing, Accept the responsibilities inherent to being a economic level, political or professional religious beliefs, or any other Uphold the dignity and respect of my profession individual characteristics. and conduct myself a reputation of reliability, Everyone is treated in the same honesty, and integrity way. Perform my task with full confidence reliability o Social Justice - is based on the and accuracy. application of equitable rights Treat any information I acquired about individuals to access and participation in in the course of my work as strictly confidential all aspects of goods and Commit myself to continuously improve my services provided in a society, professional skills and knowledge regardless of their individual Share my knowledge and expertise to my characteristics. Everyone colleagues 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 18 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM PHYSICAL RISKS Excessive the most common form of risk after Contribute to the advancement of the bleeding abortion and may be professional organization and other allied health due to a torn cervix or punctured organizations uterus. Act in a spirit of fairness to all and a spirit of Infection may be caused by the introduction brotherhood to other members of the profession of bacteria-contaminated Restrict my praises, criticisms, views, opinions instrument during operation. within constructive limits Pelvic the most common infection to occur Accept employment from more than one inflammatory in women who have undergone employer only when there is no conflict of interest disease (PID) abortion. Be dedicated to the use of Clinical laboratory science to promote life and benefit mankind Uphold the law and shall not engage in illegal Multiple abortions may weaken the cervix. Moreover, work women who have undergone abortion increase their risk of Report any violation of the above principles of becoming sterile in the future. professional conduct to the authorized agency EMOTIONAL AND PSYCHOLOGICAL RISKS and the ethics committee of the organization. Women who have experienced abortion have a To these principles, I hereby subscribe and pledge to much higher risk of developing longer-term conduct myself at all times in a manner befitting the dignity clinical depression compared with non-abortive of my profession. women. Among these emotional risks are depression and anxiety, substance abuse, relationship and sexual difficulties, smoking, suicide, and post-abortion stress syndrome (PASS). CRIME IN THE PHILIPPINES ABORTION Two types of abortion according to the Philippine Revised the termination of a pregnancy at any time within Penal Code: the 9-month period prior to childbirth. Taking a pill or undergoing a surgical procedure Article. 256. Intentional abortion. – Any person who shall (in-clinic abortion) are two ways of carrying out intentionally cause an abortion shall suffer: the procedure. The penalty of reclusion temporal, if he shall use In some countries, abortion is a legal medical any violence upon the person of the pregnant procedure which can be performed if the patient woman. meets certain qualifications. The penalty of prision mayor if, without using In the United States, 3 out of 10 women have an violence, he shall act without the consent of the abortion by the time they are 45 years old. woman. In the United Kingdom, the Abortion Act of 1967 The penalty of prision correccional in its medium covers England, Scotland, and Wales. and maximum periods, if the woman shall have In the Philippines, although there are no laws that consented. state abortion is legal, there is still a steady rise of Article. 257. Unintentional abortion. – The penalty of cases of abortion. prision correccional in its minimum and medium period The Church and the government have constantly shall be imposed upon any person who shall cause an lashed regarding the ethical issue of whether to abortion by violence, but unintentionally. legalize the procedure or not. 11 08 2024 | 1ST SEMESTER A.Y. 2024 – 2025 Page 19 of 21 ROSELL, CHIA LIEN  MLS 037: Principles of Medical Laboratory Science 1 (LECTURE) SUMMATIVE EXAM NOTES PMLS 1 TEAM per year, a number expected to rise unless urgent action is taken towards its abandonment. Considering the provisions of the Revised Penal Code (RPC) comprises all procedures that involve partial or of the Philippines, abortion is a crime and really punishable total removal of the external female genitalia, or by law whether the reasons for carrying it out are other injury to the female genital organs for non- intentional or unintentional. medical reasons. The practice has no health benefits for girls and women and cause severe bleeding and problems urinating, and later cysts, infections, as well as Euthanasia is the practice of ending a life complications in childbirth and increased risk of intentionally, usually in situations when the newborn deaths. individual is terminally ill, to relieve him or her of The practice of FGM is recognized internationally pain and suffering. as a violation of the human rights of girls and known as mercy killing women. regarded as a merciful release of an individual In 2008, the World Health Assembly passed from an incurable sickness either through resolution WHA61.16 on the elimination of FGM, voluntary, non-voluntary, or involuntary means. emphasizing the need for concerted action in all Voluntary euthanasia - is when an individual gives sectors: health, education, finance, justice and consent to subject himself or herself to painless death. women's affairs. Cultural and social factors for performing Non-voluntary euthanasia - is conducted when the FGM permission of the patient to perform the process is The reasons why FGM is performed vary from o