This document discusses the nature and classifications of clinical laboratories in the Philippines according to R.A. No. 4688, which regulates their operation, maintenance, and registration. Clinical laboratories process and analyze specimens to diagnose diseases. They are classified by function, ownership, service capability, and institutional characteristics. The law designates the Department of Health to license and monitor laboratories. Laboratories must implement quality assurance measures to ensure reliable test results.
This document discusses the nature and classifications of clinical laboratories in the Philippines according to R.A. No. 4688, which regulates their operation, maintenance, and registration. Clinical laboratories process and analyze specimens to diagnose diseases. They are classified by function, ownership, service capability, and institutional characteristics. The law designates the Department of Health to license and monitor laboratories. Laboratories must implement quality assurance measures to ensure reliable test results.
This document discusses the nature and classifications of clinical laboratories in the Philippines according to R.A. No. 4688, which regulates their operation, maintenance, and registration. Clinical laboratories process and analyze specimens to diagnose diseases. They are classified by function, ownership, service capability, and institutional characteristics. The law designates the Department of Health to license and monitor laboratories. Laboratories must implement quality assurance measures to ensure reliable test results.
This document discusses the nature and classifications of clinical laboratories in the Philippines according to R.A. No. 4688, which regulates their operation, maintenance, and registration. Clinical laboratories process and analyze specimens to diagnose diseases. They are classified by function, ownership, service capability, and institutional characteristics. The law designates the Department of Health to license and monitor laboratories. Laboratories must implement quality assurance measures to ensure reliable test results.
PMLS-1 (Finals) Law on the Operation, Maintenance, and
Registration of Clinical Laboratories in the
Lecture 1: THE NATURE OF THE CLINICAL Philippines LABORATORY R.A. No. 4688 – regulates the OMR of clinical Clinical Laboratory – the place where specimens (e.g., laboratories and the registration of the same (An act blood and other body fluids, tissues, feces, hair, nails) regulating the operation and maintenance of clinical collected from individuals are processed, analyzed, laboratories and requiring the registration of the same preserved, and properly disposed. They vary according with the department of health, providing penalty for the to size, function, and the complexity of tests performed. violation thereof, and for other purposes). Classifications of Clinical Laboratories Sections of the Clinical Laboratory ➢ According to Function 1. Clinical Chemistry – intended for the testing of o Clinical Pathology – concerned with the blood and other body fluids to quantify essential diagnosis and treatment of diseases performed soluble chemicals including waste products useful through laboratory testing of blood and other for the diagnosis of certain diseases. body fluids. 2. Microbiology – subdivided into four sections: o Anatomic Pathology – concerned with the bacteriology, mycobacteriology, mycology, and diagnosis of diseases through microscopic virology. The work in this section is more focused examination of tissues and organs. on the identification of bacteria and fungi on ➢ According to Institutional Characteristics specimens received. o Institution-based – operates within the 3. Hematology and Coagulation – deals with the premises or part of an institution such as a enumeration of cells in the blood and other body hospital, school, medical clinic, medical facility, fluids (e.g., CSF, pleural fluid, etc.). Coagulation etc. studies focus on blood testing for the determination o Free-standing – not part of an established of various coagulation factors. institution; e.g., out-patient clinical laboratory 4. Clinical Microscopy – two major areas in this ➢ According to Ownership section of the laboratory: (1) the first area is allotted o Government-owned – owned, wholly or to routine and other special examinations of urine; partially, by national or local government units. examination of other body fluids is also performed o Privately-owned – owned, established, and in this area; (2) the second area is assigned to the operated by an individual, corporation, examination of stool or routine fecalysis; detection institution, association, or organization. and identification of parasitic worms and ova are the ➢ According to Service Capability primary activities in this area. o Primary Category – licensed to perform basic, 5. Blood Bank/Immunohematology – blood typing routine laboratory testing (routine urinalysis, and compatibility testing are the two main activities routine stool examination, routine hematology, performed in this section. Screening for all CBC); space requirement is at least 10 square antibodies and identification of antibodies as well as meters. the blood components used for transfusion are also o Secondary Category – licensed to perform conducted in this section. This section is considered laboratory tests being done by the primary as the most critical in the clinical laboratory. category clinical laboratories along with routine 6. Immunology and Serology – analyses of serum clinical chemistry like blood glucose antibodies in certain infectious gents (primarily viral concentration, BUN, BUA, blood creatinine, agents) are performed in this section. cholesterol determination, qualitative platelet 7. Histopathology/Cytology – activities in this count; space requirement is at least 20 square section include tissue (removed surgically as in meters. biopsy and autopsy) processing, cutting into o Tertiary Category – licensed to perform all the sections, staining, and preparation for microscopic laboratory tests performed in the secondary examination by a pathologist. category laboratory plus (1) immunology and 8. Immunohistochemistry – a specialized section of serology, (2) microbiology, bacteriology, and the laboratory that combines anatomical, clinical, mycology, (3) special clinical chemistry, (4) and biochemical techniques where antibodies special hematology, (5) immunohematology (monoclonal and polyclonal) bounded to enzymes and blood banking; space requirement is at and fluorescent dyes are used to detect presence least 60 square meters. of antigens in tissue. This is useful in the diagnosis o National Reference Laboratory – a laboratory in of some types of cancers. a government hospital designated by the DOH 9. Molecular Biology and Biotechnology – primarily to provide special diagnostic functions and using different enzymes and other reagents, DNA services for certain diseases. and RNA are identified and sequenced to detect any pathologic conditions/disease processes. The most common technique currently in use is the 4. CHD – Center for Health Development PCR. 5. EQAS – External Quality Assurance System 6. NRL – National Reference Laboratory Laboratory Testing Cycle 7. QA – Quality Assurance 8. PCR – Polymerase Chain Reaction 9. QC – Quality Control 10. TAT – Turn Around Time
Post-Test:
1. CBC and routine urinalysis are performed in:
Primary Laboratory and Tertiary Laboratory 2. The government agency responsible for the licensing and monitoring of clinical laboratories in the Philippines is: DOH 3. The law that governs the operation, registration, and maintenance of clinical laboratories in the Quality Assurance in the Clinical Laboratory Philippines: R.A. 4688 4. Implementing Rules and Regulations of R.A. 4688: – Covers all activities performed by lab personnel to 5. Clinical Chemistry, Medical Microbiology, ensure reliability of test results. Hematology and Coagulation Studies are the sections that comprise: Clinical Pathology ➢ Internal Quality Assurance System (IQAS) – 6. Which of the following is laboratory testing includes day-to-day activities that are undertaken in performed in a non-hospital-based secondary order to control factors or variables that may affect clinical laboratory? ABO and Rh blood typing test results. Regular review and audit of results are 7. Makati Medical Center, St. Luke’ Medical Center, done in order to identify weaknesses and MCU-FDTMF Hospital are examples, according to consequently perform corrective actions. ownership, of: Institution-based and Tertiary level ➢ External Quality Assurance System (EQAS) – a 8. Which of the following are activities performed in system for checking performance among clinical Anatomic Pathology? Tissue processing for laboratories and is facilitated by designated microscopic examination and Tissue processing for external agencies. isolation of pathogenic bacteria o NRL – the DOH-designated EQAS. An 9. The primary responsibilities of a medical unknown sample with known test results is technologist in a clinical laboratory is to: Ensure regularly sent to a clinical laboratory for testing. reliability of test results and Control Results are then returned to the external facility variables/factors during the laboratory testing cycle and are compared with the known result. that may affect test results Designated NRL-EQAS (National Reference 10. Variables of possible sources of errors in the Laboratories) analytic phase of laboratory testing cycle include: Working conditions of equipment and instruments 1. National Kidney and Transplant Institute (NKTI) and Quality of test reagents, controls, and – Hematology and Coagulation standards used during the testing proper 2. Research Institute of Tropical Medicine (RITM) – Microbiology (identification and antibiotic Lecture 2: PROFESSIONAL ORGANIZATIONS susceptibility testing) and Parasitology Professional Organizations (identification of ova and quantitation of malaria) 3. Lung Center of the Philippines (LCP) – Clinical ➢ A group composed of professional within a career Chemistry (for testing 10 analytes, namely glucose, filed who come together for individual professional creatinine, total protein, albumin, BUN, uric acid, development, advancement, networking, and cholesterol, Na, K, and chloride) collaboration. 4. East Avenue Medical Center (EAMC) – drugs of ➢ Helps in the promotion of the field as well as abuse (methamphetamine and cannabinoids) educating the public on issues related to the 5. San Lazaro Hospital STD-AIDS Cooperative industry and in representing interests of industry Center Laboratory (SACCL) – infectious before the local and national government. immunology hepatitis B surface antigen (HBsAg), ➢ Typically, members pay annual dues to receive HIV, HCV unlimited access to resources, benefits, and/or services. Pre-Test: Transcribe the following acronyms. Benefits of Membership in Professional 1. RITM – Research Institute for Tropical Medicine Organizations 2. DOH – Department of Health 3. BHFS – Bureau of Health Facilities and Services 1. Professionalism – adhere to the set of rules or 3. Professional Societies – are professional code of ethics prescribed by the professional organizations that contribute to the continued society professional development of a specific group of 2. Education – through conventions, seminars, fora, professionals. Membership in a national society workshops, and other activities of similar nature; usually also includes membership in that society’s publish research journals local/state affiliate. 3. Perks – monetary discounts on registration fees for professional development activities of the Local Professional Societies: organization ➢ PAMET – Philippine Association of Medical 4. Networking – gatherings and other activities can Technologists be potential avenues for creating long-term linkages ➢ PCQACL – Philippine Council for Quality and connections with other professionals Assurance in Clinical Laboratory 5. Profile – build the career portfolio of a professional ➢ PBCC – Philippine Blood Coordinating Council 6. Regulation – professional organizations recognize ➢ PASMETH – Philippine Association of Schools for their outstanding members and leaders in the Medical Technology/Medical Laboratory Science practice and special fields and Public Health Types of Professional Organizations International Professional Societies: 1. Accrediting Organizations – organizations that ➢ ASCP – American Society for Clinical Pathology accredit curricular programs in educational ➢ AMT – American Medical Technologists institutions. The educational institution applying for ➢ ASCLS – American Society for Clinical Laboratory accreditation will then be visited by technical Science committee of experts from the accrediting agency ➢ IAMLT – International Association of Medical who will verify the compliance of the educational Laboratory Technologists institution. ➢ ISCLT – International Society for Clinical Local Accrediting Agencies: Laboratory Technologists ➢ CLMA – Clinical Laboratory Management ➢ CHED Association ➢ PAASCU – Philippine Accrediting Association of ➢ CLSI – Clinical Laboratory Standards Institute Schools, Colleges, and Universities (formerly NCCLS) ➢ PACUCOA – Philippine Association of Colleges ➢ AAMLS – Asia Association of Medical Laboratory and Universities Commission on Accreditation Scientists ➢ AAMLT – ASEAN Association of Medical International Accrediting Agencies: Laboratory Technologists ➢ CAAHEP – Commission on Accreditation of Allied ➢ IFBLS – International Federation of Biomedical Health Education Laboratory Science ➢ NAACLS – National Accrediting Agency for Clinical PAMET Laboratory Science ➢ ABHES – Accrediting Bureau of Health Education ➢ National professional organization of all registered Schools medical technologists in the Philippines. ➢ Non-stock profit organization 2. Credentialing/Certifying Agencies – agencies ➢ First organized on September 15, 1963 by Crisanto that provide certification examination for G. Almario (Father of PAMET) at the Public Health professionals specifically medical technologists and Laboratory in Quiricada St., Sta. Cruz, Manila. other laboratory professionals. Certified ➢ First PAMET President: Charlemagne T. professionals are then required to renew their Tamondong licenses at a specified length of time (3 years). ➢ R.A. 5527 on June 21, 1989: Philippine Medical Local Credentialing/Certifying Agencies: Technology Act
➢ PRC – Professional Regulation Commission The PAMET Insignia:
International Credentialing/Certifying Agencies:
➢ AMT – American Medical Technologists (California,
Georgia, Florida) ➢ ASCP – American Society for Clinical Pathology ➢ ISCLT – International Society for Clinical Laboratory Technology ➢ NCA – National Certifying Agency for Medical Laboratory Personnel ➢ Circle – symbolizes the continuous involvement PHISMETS where practice and education must always be integrated ➢ Philippine Society of Medical Technology Students ➢ Triangle – the trilogy of love, respect, and integrity ➢ The national organization of all MT students under ➢ Green – the color of health PASMETH ➢ Microscope & Snake – symbolize the science of ➢ First organized in 2002 the Medical Technology profession The PHISMETS Seal: ➢ 1964 – the years the first PAMET Board was elected
➢ Philippine Association of Schools of Medical ➢ 3 Circles – symbolize the continuous active
Technology/Medical Laboratory Science and Public involvement of Luzon, Visayas, and Mindanao in Health, Inc. the national transforming venue of medical ➢ The national organization of all recognized schools laboratory science students of BSMT, BSMLS, and BSPH in the Philippines. ➢ Laurel – symbolizes nature and the continuation of ➢ Organized in 1970 in the hopes of maintaining the life every year highest standards of MT education and to foster ➢ Green Letters – represent the color of health closer relations among MT schools in the ➢ 5 Bubbles from a Test Tube – represent the 5 Philippines. objectives embodied in the constitution of the organization The PASMETH Seal: ➢ 15 Interconnected Molecules Outside a Test Tube – signify the unity of the 15 board schools exploring various possibilities and aiming towards the integral growth and holistic development of medical laboratory science students ➢ Microscope – represents medical laboratory science
Pre-Test:
1. What is the accredited professional organization of
registered Medical Technologists in the Philippines? ➢ Circle – represents the continuity of learning and – PAMET the never-ending quest for excellence in the 2. What is the national organization of schools of academic field. Medical Technology in the Philippines? – ➢ Diamond – the four corners represent the four PASMETH objectives of the Association: 3. Which of the following is not a benefit for joining a o to encourage a thorough study of the needs and professional organization? – none of the above problems of Medical Technology and Public 4. What type of professional organization provides Health education and to offer solutions to them certification to members who will undergo o to work for the continuous development of membership through training and examination? – Medical Technology and Public Health credentialing organization education in order that the profession will be of 5. Which international professional organization maximum service to the country provides certification examinations for Medical o to take a united stand on matters which affect Technologists in the Philippines? – AMT and ASCP the interests of Medical Technology and Public Health education Post-Test: o to seek the advice, aid, and assistance from 1. ASCP – American Society for Clinical Pathology any government or private entity for the 2. AMT – American Medical Technologists fulfillment of the association’s aims and 3. PAMET – Philippine Association of Medical purposes Technologists ➢ Microscope – represents the field of Medical 4. PHISMETS – Philippine Society of Medical Technology and Public Health Technology Students ➢ 1970 – the year the Association was founded 5. PASMETH – Philippine Association of Schools of units per year for 3 years (PRC renewal of license Medical Technology and Public Health, Inc. is every 3 years) 6. PCQACL – Philippine Council for Quality Assurance in Clinical Laboratories R.A. 10912 7. PBCC – Philippine Blood Coordinating Council ➢ Took effect on August 16, 2016 8. APJOMLAS – Asia Pacific Journal of Medical ➢ The law mandated the strengthening of CPD Laboratory Science programs for all regulated professions and the 9. AACLS – ASEAN Association of Clinical Laboratory creation of CPD Councils for each profession Sciences ➢ This defines lifelong learning as “learning activities 10. IFBLS – International Federation of Biomedical undertaken throughout life for the development of Laboratory Science competencies and qualifications of the profession.” 11. He is considered as the father of PAMET – Crisanto ➢ The law also defines CPD as “the inculcation of G. Almario advanced knowledge, skills, and ethical values in a 12. It is the oldest local chapter of PAMET - post-licensure specialization or in an inter- or 13. Identify the number of PAMET local chapters in the multidisciplinary field of study, for assimilation into Philippines – 46 (?) professional practice, self-directed research, and/or 14. He or she is the current President of PAMET – Ms. lifelong learning Luella Vertucio 15. He or she is the current President of PASMETH – Pre-Test: Dr. Jose Jurel Nuevo 1. The CPD Law of 2016 is also known as – R.A. 16. Name at least one PAMET president who later 10912 became a PASMETH president – Nardito D. 2. If a medical technologist renewed his or her PRC ID Moraleta last May 25, 2017, how many CPD units would be 17. It is the theme during the administration of Mr. most likely required of him or her? – 15 Romeo Joseph Ignacio – Golden Celebration 3. Which government agency regulates the practice of 18. It is the professional society of medical medical technology? – Professional Regulation technologists in Japan – Japan Association of Commission Medical Technologists (JAMT) 4. At least how many days prior to the CPD activity 19. It is the organization of medical technology students should CPD providers submit their application for under the auspices of PASMETH – PHISMETS CPD activities to the CPD Council? – 45 days 20. It is the association of medical technologists in the 5. How many CPD units are required for the renewal ASEAN region – ASEAN Association for Clinical of the PIC of medical technologists every 3 years? Laboratory Sciences (AACLS) – 45 Lecture 3: CONTINUING PROFESSIONAL 6. Whose executive order initiated the requirement for DEVELOPMENT (CPD) CPE units for the renewal of professional licenses? – Fidel Ramos Lifelong Learning for Professionals 7. The PRC Moderation Act of 2000 is also known as ➢ Learning happens through the course of a lifetime. – R.A. 8981 ➢ Does not stop once graduation togas are donned 8. The first member of the CPD Council for Medical and diplomas are conferred. Technology is the president of this organization. – PAMET Lifelong Learning 9. This refers to a common reference framework that enables comparison of education qualifications ➢ Skills that are on a par with the requirements of the across ASEAN member states. – AQRF (ASEAN company Qualifications Reference Framework) ➢ Higher level of education = better health care 10. The implementation of R.A. 10912 started on – delivery and improved patient outcomes March 15, 2017 ➢ A demand in an environment filled with global markets ➢ For mobility of professionals – ASEAN Qualifications Reference Framework
CPD
➢ Ensures the competency of professionals
➢ Longest phase of professional education ➢ Individual’s improvement, progression, and career growth ➢ For registered medical technologists, the required number of CPD units is 45 units or an average of 15