Medical Technology Laws and Bioethics UNIT OI INTRODLCTIONANDHSTORY OF MEDICAL TECH\OLOGY ANCIENT LABORATORY PRACTICES ‘THE PUBLIC HEALTH LABORATORY » Hippocrates - the father of medicine » itwas the first laboratory in the and discovered the 4 humors Philippines > Antistius - first forensic pathologist and > headed by Dr. Pio De Roda performed autopsy on the corpse of » located at Quiricada Street, Sta. Cruz, Julius Caesar. Manila > Indian physicians - observed that ‘THE MANILA SANITARIUM AND HOSPITAL. some types of urine attracted insects > began in July 1929 due to high sugar content and called > Manila Sanitarium Hospital in 1953 ‘madhumeha” or honey urine. >_ managed by Dr. Horace A. Hall > Isaac Judaeus- devised guidelines for using urine as a diagnostic aid, > Philippine Union College > Under the leadership of Mrs. Willa MEDIEVAL LABORATORY PRACTICES Hedrick the wife of Dr. Elvin Hedrick > Anton Van Leeu hhoek invented PHILIPPINE ASSOCIATION OF MEDICAL TECHNOLOGISTS, INC PAMET) the Leeuwenhoek microscopes which had better magnification, clarity and > founded on September resolution, 15, 1963, > Johannes Muller- describe the » CRISANTO G. microscopic structure of various types of ALMARIO- father of cancer. PAMET > Rudolf Virchow- established the > CHARLEMAGNE T. fundamentals of cellular pathology. TAMONDONG.- first president > Alexander Fleming- made the landmark observation that the mold Penicillium killed staphylococci in v PAMET HYMN- written by Hector G. Gayares and set into music by Francis Jerota Pefanco culture. PAMET PRESIDENTS AND THEIR ADVOCACY: > Karl Landsteiner- discovered the major TERM PRESIDENT "ADVOCACY blood groups in 1909 19621967 | Charlemagne T. | Emergence ofthe ae Tamondong Profession - existing medical approaches were 1967-1970 | Nardito D. Moraleta Professional improved. Recognition -School of Public Health and Hygiene- course 1967-1970 Felix E. Asper a analogous to medical technology education. STATS Bernardo T. Celebration of the Tabaosares Profession > World War- army surgeons taught 1373 ‘Angelina R. Jose | Career Advocacy Filipinos of the practice of medical 7977-1982 | Venerable C.V. Oca Educational technology. Enhancement 4982-1992 | CarmencitaP. Acedera | Image Building Medical Technology Laws and Bioethics 'Medical Technology Laws and Bioethics 7992-1996 | Marilyn R. Atienza Proactivism 1997-2000 | Norma N. Chang International Leadership 2001-2002 | Shirley F. Cruzada__| Organizational Dynamism 2003-2006 | Agnes B. Medenilla | Interdisciplinary Networking | 2005-2006 | Leila M. Florentino Global Perpective 2007-2013 | Romeo Joseph Jacinto Golden Celebratio. 2013-2015 | Rolando E. Puno Empowerment present | — Luella Vertucio | (PASMETE > isthe nationel organization of > is the national organization of all medical technology students recognized schools and colleges of > is a special program that serves medical technology and public as a transforming venue for the health in the Philippines. integral and holistic > Established on May 13, 1970 » development of medical > First organizational meeting technology! medical laboratory University of Sto. Tomas : science students > First president: Gustavo U. Reyes Medical Technology Laws and Bioethics uMedical Technology Laws and Bioethics UNIT 02 a aN =h (em eS ler Mote a eee) SECTION 1: TITLE > This act may be also cited as “The Philippine Medical Technology Act of 1979" > Act requiring the registration of Medical Technologist in the Philippines, defining their practice, and for other purpose relative to performance This law was approved on June 21, 1969. And has been in force for the past S0years. v NOTE: Senate Bill Nos.2473 and 2772 are being lobbied to repeal RA. No.5527 and address issues introduced by modernization. > To ensure that the professional services expected from medical technologist are to be rendered by competent and licensed individuals, -R.A. No. 5527 is a special penal law because this statute prohibits certain acts and establishes penalties for the violations, > Aperson shall be deemed to be in the practice of medical technology within the meaning of this ‘Act, who shall for a fee, salary, or other compensation or reward paid or given directly or indirectly through another, renders any of the following professional services. Examination of tissue, secretions, and excretions of human body fluids. Blood banking procedures and techniques: Parasitology, Mycologic and Microbiologie procedures and techniques; Histopathologic and Cytotechnology Clinical Research Preparation and standardization of reagents Clinical Laboratory Quality Control Collection and Preservation of specimen, Medical Technology Laws and Bioethics B. Pathologist > Registered physician who is specially trained in methods of laboratory medicine, or the gross ‘and microscopic study and interpretation of tissues, secretion and excretions of the human body and its functions in order to diagnose disease. > Clinical Pathologist- a physicians that diagnose and monitor disease Bodily fluids (blood, urine, cerebrospinal, fluids and others), > Anatomic Pathologist- Diagnose of disease though examining specimens derived from surgical procedure. Biopsy specimen (organ, tissue o mass). C. Medical Technologist A person who engages in the work of medical technology under the supervision of a pathologist or licensed physician authorized by the Department of Health (Bachelor of Science in Medical Technology/Bachelor of Science in Hygiene) of training and examination is registered under the provision of this Act. D. Medical Technician A person certified and registered with the Board as qualified to assist a medical technologist and/or qualified pathologist in the practice of ‘medical technology as defined in this Act. v v v > Aclinical laboratory, office, agency, clinic, hospital or sanitarium duly approved by the Department of Health or its authorized agency. > Any school, college, or university which offers a course in Medical Technology approved by the Department of Education in accordance with the requirements under this Act, upon recommendation of the council of medical technology education. uMMedical Technology Laws and Bioethics > The council of medical technology education established under this Act. > The Board of Examiners for Medical Technology established under this Act. HERTEBIBEY is the study of the fundamentals of blood as a tissue, including pathophysiology and the mechanism of coagulation and hemostasis. It also includes blood cell disorders, special hematology evaluation, quality control, and quality assurance ‘SEBBIBGY isa branch of medicine and biology dealing with blood serum in regard to its immunological reactions and properties. (RURBIBRY isa branch of medicine and biology that deals with the study of the immune system. (SHHBEEHBHEER is the study of heredity and inheritance, genetic phenomena, sex determination, and defects in relation to human inheritance [BISBGIBEHIMAH deals with the concepts and principles of diferent red cell antigen systems and the application of specific bload group antigens and antibodies to ccompatibity testing. It also deals with the entire blood donation process or transfusion medicine. _BEEESHEBIBGY is tho study of human parasites of imedical importance as to their morphology, ‘epidemiology, pathogenicity, distribution, and life cycle, ‘as well as control and preventive measures against infection, GIEBIBRY is the study of morphologic and biologic characteristics of fungi as agents of disease, while Virology deals with the study of morphologic and biologic characteristios of viruses that are pathogenic to humans. HESESBEERBIBAY is the study of the histologic techniques ‘essential in the production of histologic slides for the diagnosis of diseases including special staining procedures, (GRISISERBIBGY is the study and identification of celis in the diagnosis of diseases using cytologic techniques. Medical Technology Laws and Bioethics > TWO TYPES OF PATHOLOGISTS Y Clinical pathologists Anatomic pathologists > Medical specialists who direct most of the divisions in a clinical laboratory. The Council is composed of the following members: CHAIRMAN: Chairperson of CHED VICE-PERSON: Chairperson of PRC MEMBERS: 1. Director of HFSRB 2.Chairman and two members of the Medical Technology Board 3.Representative of Philippine Association of School of Medical Technology and Public Health, Inc. (PASMETH) 4,President of Philippine Association of Medical Technologist, Inc. (PAMET) 5.President of Philippine Society of Pathologist, Inc. (PSP) ‘SECTION 4: COMPENSATION AND TRAVELING EXPENSES OF COUNCIL MEMBERS Chairman shall be entitled P50.00 per diem (Members shall be entitled P25,00 ‘SECTION 5: FUNCTION OF THE COUNCIL OF MEDICAL TECHNOLOGY a. To recommend the minimum required curriculum for course of medical technology. b. To de and prescribe the number of students to take up the medical technology course in each school, taking info account the student: instructor ratio and the availablity of facilities for instruction. ¢. To approve medical technology schools that meet the requirements and recommend closure of those found to be substandard, 4. To require all medical technology schools to submit an annual report e. To inspect, when necessary, the different medical technology school in the country {, To certify for admission in to an undergraduate intemship a student who has satisfactorily completed 3 years of the medical technology course,Medical Technology Laws and Bioethics 9. Formulate and recommend approval of refresher ‘course for applications who shall have failed the Board Examination for the third time. h. To promulgate and prescribe and enforce necessary rules and regulations. > Composed of a Chaitman who is a Pathologist, 2 members who are Registered Medical ‘Technologist who shall be appointed by the President of the Republic of the Philippines upon recommendation of the Professional Regulation Commission (PRC Chairman: Dr.Marlyn A. Cabal-Baza (Histopathology) Members; Dr. Leila Lany M. Florento Dr. Grace J. Dela Calzada (2020-2023) 1.Filipino Citizen 2.Good moral character 3.Qualified Pathologist/ Bachelor of Science in Medical Technology! Bachelor of Science in Hygiene / Public Health 4.Have practice Laboratory Medicine or Medical Technology for atleastn10 years 5.Not a member of the faculty of any medical technology school for at least 2 years > The Commissioner of Civil Service shall be the Executive Officer of the Board, and shall conduct, the examinations given by it > The secretary of the Board Examiners appointed in accordance with section 10 of Act, 4007, as amended, shall also be the Secretary of the Board, > Hel She shall keep a register of all persons to whom cerlificates of registration have been granted. > The members of the Professional Regulatory Boards shall receive compensation equivalent to, at least two salary grades lower than the salary grade of the Commissioners. Medical Technology Laws and Bioethics > Atpresent the salary grade of a Commissioner of the PRC is equivalent to that of a Department Undersecretary. CLASSIFICATION OF MTB A, Administrative Power - Concern with the work of applying policies and enforcing orders as determined by proper government organs. B, Quasi legis/ative Power - “Rule-making Power” C. Quasi- judicial Power - It hear and determine questions of fact to which the legislative policy and to decide in accordance with the standards laid down by the law itself in enforcing and administering the same law. ‘SECTION 12: REMOVAL OF BOARD MEMBERS Requirements: a. He / She must be removed by the President of the Philippines b. Hel She must be removed for a valid ground Hel She must be given an opportunity to defend himself/herself in an administrative investigation GROUNDS FOR REMOVAL 4.Neglect of Duty TWO TYPES 4.Gross Neglect of Duty 2.Simple Neglect of Duty 2.Incompetency 3.Malpractice 4.Unprofessional conduct, 5.Unethical conduct 6.lmmoral conduct, 7.Dishonorable conduct 8.Commission of regulatory in the licensure examination Possible Sanctions if Schoo! failed to secure an authority to operate from CHED 1.Program termination 2.Schoo! closureMedical Technology Laws and Bioethics Possible Sanctions if or program for Medical ‘Technology education failed to comp) 4.Dimunution or withdrawal of sudsidy 2. Downgrading of accreditation 3.Witdrawal of termination 4.Program termination 5.School Closure provided that registration shall not be required of the following a, Duly registered physicians b. Medical technologists from other countries called in for consultation or as visiting or exchange professors to colleges or universities: Provided, they are only practicing the sald function. c. Medical technologists in the service of the United States Armed Forces stationed in Philippines rendering services for members of the said forces only. ‘SECTION 45: EXAMINATION > Except as otherwise specifically alowed under the provision of this Act, all applicants for registration as medical technologist shall be required to undergo written examination which shall be given by the Board annually in the greater Manila area, Cebu, and Davao during the month of August or September on such days and places as the Board may designate. Written notices of such examination shall be published in at least three newspapers of national circulation by the Secretary of the Board of least thirty days prior to the date of examination, PRESENT BOARD: March and September WHERE: Manila, Baguio, Cagayan de Oro, Davao, Iloilo, Tacloban, Tuguegarao and Zamboanga. Every applicant examination under this Act, shall, prior to the date thereof, furnish the Boo satisfactory ‘proof that he or she a. Is in good health and is of good moral character; b. Has completed a course of at least four (4) years leading to the degree of Bachelor of Science in Medical ‘Technology or Bachelor of Science in Public Health conferred by a recognized school, college or university in accordance with this Decree or having graduated from ‘some other profession and has been actually performing medical technology for the last five (5) years prior to the Medical Technology Laws and Bioethics date of the examinations, if such performance began prior to June 21, 1969, Section 16 paragraph {a) is an original provision of the 1969 law. Section 16 paragraph (b) was introduced by P.D. No. 498, Hematology Blood Banking and Serology Clinical Microscopy Histopathologic techniques, Cytitechnology and etc. vyvvvy > The Board shall, within 120 days after the date of completion of the examination, report the result thereof to the Commissioner of Civil Service, who shall submit such result to the President of the Philippines for approval. This is an original section of the 1969 law. > In order to pass the examination, a candidate ‘must obtain a general average of at least seventy-five percent in the written test, with no rating below fifty percent in any of the major subjects. > The Board shall charge each applicant for examination and registration the sum of fifty pesos for each certificate of registration issued without prior examination in accordance with the provisions of this Act the sum of twenty-five pesos; for issuance of a new certificate to replace certificate lost, destroyed or mutilated, the Board shall charge the sum of ten pesos. All such fees shall be paid to the disbursing officer of the Civil Service Commission who shall pay from the receipts thereof, all authorized expenses of the Board including the compensation of each member. This provision was introduced by r.a. no. 6138. viMedical Technology Laws and Bioethics Medical Technology Laws and Bioethics vilMedical Technology Laws and Bioethics UNIT 03 INUING PROFESSIONAL DEVELOPMENT ACT OF 2016 PD 223 EO #496 » December 09, 1991 ® June 22,1973 > Institutes procedures and criteria for the » Civil Service Commission (CSC) selection and the recommendation of nominees for appointment to vacant positions in the Basset » Professional Regulatory Board under the » The PRC Modemization Act of 2000 ‘supervision of the PRC. » Professionals — “nation Building” > ‘Licensure exam” > 45M lyear for 5 years (program of Full > May 14, 1992 > The policies adopted by the PRC on the delisting of delinquent professionals from gthe rolls of registered professionals. Computerization) 1. Full Time Chairperson > April 19, 1993 2. Full Time Commissioners % Appointed by the president > Resolution which gives the guidelines and Term of 7 years without reappointment procedures on the mass oath taking ceremonies of professionals and as new members of the QUALIFICATIONS accredited professional organizations Z pryears of age PRC Resolution No, 323 > Professional > Familiar with the principles and methods of > duly 27, 1984 > The policies on non-admissions of foreigners to the licensure examinations and the practice of their professions. > September 20, 1994 professional regulation > 5 years of executive or management experience > Hon, Teresita R, Manzala > Hon, Alfredo Y, Po > Hon. Jennifer J. Manali > Institutionalized the full computerization of the licensure examination administered by the various regulatory board under the supervision of the PRC, EXERCISE OF POWERS AND FUNCTIONS, > General administrative PRC Resolution No. 332 > ExeculivePolicy-making % September 29, 1994 > Establish and maintain high standard of > Amendments to and incorporation of provisions admission to the practice of all professions Ensure and safeguard the INTEGRITY of all licensure examination v > January 05, 1988 > Amendments made to PD 223 (article |, IIl and X; sections 1, 10, 18-22) Medical Technology Laws and Bioethics con licensure exams and board obligations in the rules and regulations goveming the practice of the professionals. villMedical Technology Laws and Bioethics PRC Resolution No. 338 > Guidelines in the implementation of £0 # 200 PRC Executive Order No. 266 > July 05, 1995 > The institutionalization of the Continuing Professional Education (CPE) program of the various professional regulatory boards under the supervision of the PRC. PRG Executive Order No, 381 > October 24, 1995 > Standardized policies and procedures for the implementation of the CPE programs. Medical Technology Laws and BioethicsMedical Technology Laws and Bioethics UNIT 04 Pe ee eM ye a2) + 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. “Approved on June 18, 1966, + Signed by Ferdinand E, Marcos + This act promulgates the rules and regulation to. the following reasons: ¥ Toprotect ¥ To promote Y Ensures the availability of clinical laboratories that are properly managed with adequate resources, with effective and efficient performance through the compliance with quality standards, DEFINITION OF TERMS + Clinical laboratory — a facility where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis and treatment of diseases. Clinical chemistry Hematology Immunohematology Microbiology Immunology Clinical microscopy Histopathology Cytology. Toxicology Endocrinology Molecular biology Cytogenetics + Other functions of the clinical laboratory: > To provide consultative advisory services covering all aspects of laboratory investigations > Mailing or distribution center, such as in a laboratory network or system > Total testing process includes pre—analytical, analytical and post-analytical procedures the document issued by the DOH to an individual, agency, partnership or corporation that ‘operates a clinical laboratory upon compliance with the requirements set forth in this Order. KKK KK KKK OK 8S Medical Technology Laws and Bioethics + LiGBHIS8S - the individual, agency, partnership or corporation to whom the license is issued and upon who rests compliance with this Order, + Mobile Clinical Laboratory — a laboratory testing unit that moves from testing site to another testing site, or has a temporary testing location. It shall have a base laboratory + Routine Tests - the basic, commonly requested tests in the laboratory, the results of which are not required to be released immediately upon completion. It shall follow the usual procedures and system in the laboratory. + Satellite Testing Site - any testing site that performs laboratory examinations under the administrative control ofa licensed laboratory, but performed outside the physical confines ofthat laboratory. + STAT Tests — tests done on urgent cases, the results of which shall be released immediately, within one (1) hour after the procedure. STAT is an abbreviation “sta'tim" which means immediately = owned, established and operated by any individual, corporation, association or organization CLASSIFICATION OF CLINICAL LABORATORY ‘BY FUNCTION + Clinical Pathology - includes Clinical Chemisty, Hematology, Immunohematology, Microbiology, immunology, Clinical Microscopy, Endocrinology, Molecular Biology, Cytogenetics, Toxicology Therapeutic Drug Monitoring and other similar disciplines + Anatomie Patholody — includes Surgical Pathology, Immunohistopathology, Cytology, Autopsy, Forensic Pathology and Molecular Pathology CLASSIFICATION OF CLINICAL LABORATORY BY INSTITUTIONAL CHARACTER + Institution Based — a laboratory that operates within the premises and as part ofan institution, such as but not limited to hospital, medical clinic, school, medical facility for overseas and seafarers, birthing home, psychiatric facilty, drug rehabilitation center + Eteestanding ~ a laboratory that does not form part of any other institutionMedical Technology Laws and Bioethics Primary Category ~ provides the following minimum, service capabilities: + Routine Hematology: Complete Blood Count — includes Hemoglobin Mass Concentration, Erythrocyte Volume Fraction (Hematocrit), Leucocyte Number Concentration (White Blood Cell or WBC count) and Leucocyte Number Fraction (Differential count) + Qualitative Platelet Determination + Routine Urinalysis + Routine Fecalysis + Blood typing - for hospital based ‘Secondary Category — provides the minimum service ‘capabilities of a primary category laboratory plus the following, + Routine Clinical Chemistry — includes Blood Glucose ‘Substance Concentration, Blood Urea Nitrogen concentration, Blood Uric Acid Substance Concentration, Blood Creatinine Concentration, Blood Total Cholesterol Concentration + Quantitative Platelet Determination * Cross matching — for hospital based + Gram Staining ~ for hospital based + KOH ~ for hospital based Tertiary Category — provides the minimum service ‘capabilities of a secondary category laboratory plus the following: + Special Chemistry + Special Hematology, including coagulation procedures + Immunology icrobiology — culture and sensitivity + Aerobie and anaerobic (for hospital and non-hospital based) Limited Service Capability (for insittion-based only) = provides the laboratory tests required fora particular service in institutions such as but not limited to dialysis centers and social hygiene clinics. Medical Technology Laws and Bioethics +A laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory. + Assisted Reproduction Technology Laboratories, Molecular and Cellular Technology, Molecular Biology, Molecular Pathology, Forensic Pathology, Anatomic Pathology laboratories Research Institute For Tropical Medicine NRL for Dengue, Influenza, Tuberculosis and other Mycobacteria, Malaria and other parasites, Bacterial enteric diseases, measles and other viral exanthemas, Mycology, Enteroviruses, Antimicrobial resistance and Emerging Diseases; NRL for confirmatory testing of blood donors and blood units, ‘San Lazaro Hospital (SACCL) NRL for HIVIAIDS, Hepatitis and Sexually Transmitted Diseases East Avenue Medical NRL for Environmental and Center Occupational Health; Toxicology and Micronutrient Assay. National Kidney and Transplant Institute NRL for Hematology including Immunohematology and Immunopathology and Anatomic Patholog) Philippine Heart Center __| NRL Anatomic Pathology of Cardiac Diseases. NRL for Clinical Chemistry xlMedical Technology Laws and Bioethics UNIT 05 ule Ne ei ossilate 70a wet) Before WWIl, blood was collected and directly administered to patients. ‘With the advent of anticoagulants, blood could be preserved and stored in Blood Banks. Voluntary Blood Donation began to be promoted after WWII. Philippine National Red Cross launched the National Blood Program owith President E. Quirino as the first Blood Donor. The original objective of the NBP was "To maintain a constant and ready supply of whole blood or plasma at least for emergency cases" ‘Subsequently, some government and private hospitals set up blood banks. Through the years, the demand for blood for transfusion grew. Because of the inability of the PNRC NBP and hospital blood banks to cope with this growing demand, commercial blood banks were established In order to assure the safety of the supply of, blood from the hospital and commercial blood banks, the government passed the Blood Bank Law in 1956. An Act regulating the collection, processing and sale of, human blood, and the establishment and operation of blood banks and blood processing laboratories. Non-hospital Based Category A Recruitment of voluntary donors Health education and counselling Donor screening and selection Blood collection Basic blood processing and testing Provision of whole blood and packed RBC Medical Technology Laws and Bioethics > Issuance, transport and distribution of blood/blood products Storage of blood/blood products Non-hospital Based Category B >in addition to those performed under the Non -hospital Based Category A, itis capable of providing, in addition to whole blood, all blood products and components Hospital-Based Category A > in addition to those performed under the Non- hospital Based Category A, itis capable of performing compatibility testing. Hospital-Based Category B >in addition to those performed under the Hospital -based Category A, itis capable of providing, in addition to Whole blood, all blood products and components; and of performing investigation of transfusion reactions and resolution of incompatible cross matching results. Recruitment of voluntary blood donors ‘Screening of blood donors Provision of health education and counselling Collection and transport of blood to Blood Banks/ Centers ©. Blood Station > Allother hospitals and PNRC chapters rendering blood services not classified as a Blood BankiCenter or Blood Collection Unit may be allowed by these rules to store blood and blood products, subject to regulation by the BRL. vy v xilMedical Technology Laws and Bioethics UN IT 06 Vn) a > ‘Approved on February 13, 1998, An act promulgating: Policies and prescribing measures for the prevention and control of HIV/AIDS in the Philippines Instituting Information and Educational Program Establishing monitoring system Creating PNAC Created by Executive Order No. 39 December 3, 1992 To oversee an integrated and comprehensive approach to HIV/AIDS prevention and control in the Philippines. Made up of 26 members of the Council: Government Civil society Other organizations The State shall promote public awareness about: Modes of transmission Consequences Means of prevention Control of HIVIAIDS Comprehensive nationwide educational and information campaign The State shall extend to every person su! ispected or known to be infected with HIVIAIDS full protection of his/her human rights and civil liberties Comp ulsory HIV testing shalll be considered unlawful The right to privacy shall be guaranteed Discrimination shall indi be considered jual and national interest. inimical to Medical Technology Laws and Bioethics The transfer of HIV from one infected person to an uninfected individual, most ‘commonly through sexual intercourse, blood transfusion, sharing of intravenous needles and during pregnancy. > The relationship of trust and confidence created or existing between a patient or a person with HIV. The process of providing an individual information on the biomedical aspects of HIVIAIDS and emotional support to any psychological implications of undergoing HIV testing and the test result itself before he/she is subjected to the test, The process of providing risk-reduction information and emotional support to a person ‘who submitted to HIV testing at the time that the test result is released > DOH - provides the HIV/AIDS educational information promoted in schools and non-formal learning systems by the ff. Departments: 1. DECS 2. CHED 3. TESDA, XillMedical Technology Laws and Bioethics UNIT 07 Net ee Nicos seN Nero le ava TNE) What is NEWBORNISCREENING? In most developed countries: ‘An integral part of routine newborn care ‘As routine as Vitamin K injection or Cord Care In the Philippines: Itis now recognized as part of the standard newbom care Which DISORDERS are screened? In the Philippines: Congenital Adrenal Hyperplasia (CAH) = 21 hydroxylase deficiency (Congenital Hypothyroidism (CH) = Primary Congenital Hypothyroidism J Glucose 6-Phosphate Dehydrogenase (G6PD) deficiency Galactosemia J Phenylketonuria (PKU) Institutionalize the National Newborn Screening System ‘SECTION 2 (Ensure that every baby born in the Philippines is offered the ‘opportunity to undergo NBS (Defining DOH as the lead agency for the implementation of NBS vey (1 Creation of an Advisory Committee on NBS (ACNBS) (DOH, DILG, NIH, NSRC, CWC, (13 reps (Pediatrics, Obstetrics, Midwife, Nurse, Family Physician, Endocrinology) Establishment and ‘accreditation of the Newborn Screening Centers (NSC) 1 Establishment of the Newborn Screening Reference Center (NSRC) Obiigation to inform Who will inform? = Any health practitioner who d assists in the delivery of a newborn (1 What information? Medical Technology Laws and Bioethics 8, oF — Availabilty, nature and benefits of NBS 1 Performance of Newbom Screening SECTION 6 After 24 hours of life but not later than 3 days. i Sick neonates in ICU must be tested by the 7th day of life — Regardless of weight and age of gestation D.DOH and PHIC shall require health institutions to provide newborn screening services as a condition for licensure and accreditation + Hospitals, Health infirmaries, Health Centers, Lyingin centers or Puericulture centers with obstetrical and pediatric services (Serve as collecting health units for blood samples Establish a Newborn Screening Team + Information, education, communication, screening, recall and management of identified cases SECTION 21-A AI collecting health facilities throughout the country shall have NBS Specimen Collection Kits AT ALL TIMES! xvMedical Technology Laws and Bioethics UNIT 08 ee ee ari ei) An act authorizing the legacy or donation of all or part of a human body after death for specified purposes > ORGAN DONATION ACT OF 1991 ~ a faclity licensed, accredited ‘or approved under the law for storage of human bodies or parts thereof, * Decedent > a deceased individual, and includes a stil-born infant or fetus. + Testator > an individual who makes a legacy of all or part of his body. «Donor ~ an individual authorized under this Act to donate all or part of the body of a decedent * Part > includes transplantable organs, tissues, eyes, bones, arteries, blood, other fluids and other portions of the human body. * Person, ~ an individual,corporation, estate, trust,partnership, association, the Government or any of its subdivisions, agencies or instrumentalities, including ‘government-owned or -controlled corporations; or any other legal entity * Physician or Surgeon > a physician or surgeon licensed or authorized to practice medicine under the laws of the Republic of the Philippines. Medical Technology Laws and Bioethics Death > the irreversible cessation of circulatory and respiratory functions or the irreversible cessation of all functions of the entire brain, including the brain stem, ‘* Any individual, at least eighteen (18) years of age and of sound mind, may give by way of legacy, to take effect after his death, all or part of his body for any purpose specified in Section 6 hereof ‘* Son or daughter of legal age Either parent ‘* Brother or sister of legal age ‘* Guardian over the person at the time of his death ‘* A legacy of donation of all or part of a human body authorizes any examination necessary to assure medical acceptability of the legacy or donation for the purpose(s) | ‘* Any hospital, physician or surgeon © Any accredited medical or dental school,college or university ‘* Any organ bank storage facility © Any specified individual ‘* Shall train qualified personnel and their staff ‘© Shall accomplish necessary form or document as proof of compliance. ‘* Legacy of all or part of the human body under Section 3 hereof may be made by wil xvMedical Technology Laws and Bioethics ‘* Alegacy of all or part of the human body Under Section 3 hereof may also be made in any document other than a will The legacy may be made to a specified legatee or without specifying a legatee. ‘In all donations, the death of a person from whose body an organ will be removed after his death for the purpose of transplantation toa living person, shall be diagnosed separately and certified by two (2) qualified physicians neither of whom should be: > Amember of the team of medical practitioners who will effect the Femoval of the organ from the body; > The physician attending to the receipt of the organ to be removed; nor > The head of hospital or the designated officer authorizing the removal of the organ. ‘© Only authorized medical practitioners in a Hospital shall remove and/or transplant any (Organ which is authorized to be removed and/or transplanted pursuant to Section § «Ifthe legacy or donation is made to a specified legate or donee, the will,card or ‘other document, or an executed copy thereof, may be delivered by the testator or donor, or is authorized representative, to the legatee or donee to expedite the appropriate procedures immediately after death. ‘If thewillcard/document was delivered: > signed statement > oral statement with 2 witnesses (sent to legate) dying declaration (physician to legatee) signed card/document found on the person Medical Technology Laws and Bioethics + if the will/card/document was not delivered: > destruction, cancellation, or mutilation of the documents > revocation of wills ‘SECTION 13 - RIGHTS AND DUTIES AFTER. DEATH ‘* The legatee or donee may accept or reject. the legacy or donation as the case may be. ‘* Any person who acts in good faith in accordance with the terms of this Act shall not be liable for damages in any civil action or subject to prosecution in any criminal proceeding of this Act, SECTION 14 - INTERNATIONAL SHARING OF HUMAN ORGANS OR TISSUES ‘* Sharing of human organs or tissues shall be made only through exchange programs duly approved by the Department of Health: Provided, That foreign organ or tissue bank storage facilities and similar establishments grant reciprocal rights to their Philippine counter parts to draw organs or tissues at any time. ‘SECTION 15 - INFORMATION DRIVE ‘* In order that the public will obtain the maximum Benefits from this Act, the Department of Health, in cooperation with insttutions,such as the National Kidney Institute,civic and non-government health organizations and other heatth related agencies, involved in the donation and transplantation of human organs,shall undertake a public information program. ‘* The Secretary of Health shall endeavor to persuade all health professionals, both government and private, to make an appeal for human organ donation. > January 7, 1992 XVIMedical Technology Laws and Bioethics UNIT 09 COMPREHENSIVEDANGEROLS DRUGS ACT 0F 2002 (RA na. 9165) 2. INSTITUTIONAL CHARACTER a) Institution- basedDTLS. b) Freestanding DTLs 3. SERVICE CAPABILITY a) ScreeningLaboratories b) Confirmatory Laboratories '# Consolidation: > Senate Bill No. 1858 of May 30, 2002 > House Bill No, 413 of May 29, 2002 > Repealing Law for RA 6425 known a Dangerous Drug Act of 1972 > RA 10640 of July 15, 2014 (SB 2285 and HB 2273 of June 9, 2014) amending section 21 of RA 9165 Date of Approval: June 7, 2002 4 President; Gloria Macapagal Arroyo 4 Number of Sections: 102 se 4 Number of Articles: 13 art ¢ DUIYEEINZOOS, the DOH promulgated the Implementing Rules and Regulations Governing the Accreditation of Drug Testing Laboratories in the Philippines. » GEISBERBAZOOS, the DOH designed a computer- based system called Interim Drug Test Operations and Management Information System (IDTOMIS). «+ IBHIGAZODS, systems engineering and development ofthe Integrated Drug Test Operations and Management Information ‘System (IDTOMIS) was initiated. + IDTIOMIS -an integrated system that captures data for accrediting DTLS and rehabilitation centers, drug testing operations at diferent levels of implementation, verification of pending transactions, and monitoring and evaluation of standards, systems, and performance. JANUARY 5, 2009 ~ Nationwide implementation of IDTOMIS R.A. NO. 6425 ~ Dangerous Drugs Act of 1972 (June 7, 2003) ~ Private or government facilty that is capable of testing a specimen to DRUG TESTING LABORATORIES(DTLs) CLASSIFICATIONS 1. OWNERSHIP a) Government DTLs b) Private DTLs Medical Technology Laws and Bioethics LABORATORY TESTS Parameters. ‘Screening Confirmatory Method, Immunoassay Chromogenic Reactions Thin Layer Chromatograp hyy Spot Tests Gas chromatograp hymass spectrometry (Gc-Ms) Characteristics ‘Simple, rapi Inexpensive, capable of ing automated With good analytic sensitivity and marginal specificity Cross reactions Qualitative Laborious but with high XvIlMedical Technology Laws and Bioethics REQUIRES TO UNDERGO DRUG TESTING ‘ MANDATORY DRUG TESTING Applicant for frearm’s license Officer and members of the military, police and other law enforcers Persons charged before the prosecutor's office w! criminal offense having an imposable penalty of imprisonment not less than 6 years & 1 day Candidates for public office, whether appointed or elected both in the national or local government, ~ Persons apprehended or arrested for violating the provision of R.A. NO. 9165 ‘* RANDOM DRUG TESTING ~ Student of secondary and tertiary schools > Officers and employees of public and private offices, whether domestic or overseas > Screening Dil (20 Sqm F.A, 10 Sam W.A) « Freestanding Screening Dtls Head > Pathologist Physician W/ Clinical Laboratory Management Training « Institution Based Screening Dt!s Head > Licensed Physician > Chemist > Medical Technologist, > Pharmacist > Chemical Engineer. > Confirmatory Dil (60 Sqm F.A, 30 Sqm W.A) Confirmatory Test Dtls Head Pathologist, > Chemist W/ Master's Degree In Chemistry Or Biochemistry > A Licensed Physician Is Allowed To Supervise At Least 10 Dtls © CHEMIST ¢ MEDICAL TECHNOLOGISTS. * PHARMACISTS * CHEMICAL ENGINEERS NRL OF TOXICOLOGY Medical Technology Laws and Bioethics * URINE ‘* BLOOD * FINGERNAILS * SALIVA (ORAL FLUID) * SCALP HAIR, SWEAT(PATCH) * TISSUE ‘CHAIN OF CUSTODY ‘* Procedures to account for each specimen by tracking its handling and storage from point of collection to final DRUG 1. Shabu ~ also called meth, crank, crystal meth, orspeed. Japan, 1888 > Dr. Nagai Nagayoshi ~ identified the active chemical in the Ephedra plant, a stimulant called Ephedrine > Crystalline form, 1919, AkiraOgata 2. Marijuana ~ Cannabis or pot > Cannabis sativa ~ for herbal medicine around 500 BC > The active metabolite is TETRAHYDROCANNABINOL(THC) ACCREDITATION Authorized drug testing shall be done by any goverment forensic laboratory or by any of DTI accredited and monitored by the DOH > CERTIFICATE of ACCREDITATION for CONFIRMATORY LAB js valid for 2 years > CERTIFICATE of ACCREDITATION for ‘SCREENING LAB is valid for 4 year > RENEWAL of ACCREDITATION is filed before 90, DAYS of expiry HFSRB or CHD “> Has authority to monitor accredited DTLs ~ They may conduct an onsite monitoring visit (unannounced) of an accredited lab(documented). > HFSRB - has the authority to investigate and, after due hearings, may suspend or revoke the accreditation of DTLs. Suspension shall not be more than 60 days > ADTL whose COA has been revoked may re-apply for a new one upon compliance. ~ Any person aggrieved with the decision of HESRB may file an appeal within 15 days from receipt of the decision to the secretary of health, XVvIllMedical Technology Laws and Bioethics NATIONAL REFERENCE LABORATORY (NRL) ~ Authorized to conduct the PT for all screening and confirmatory DTLS. VIOLATION AND PENAL PROVISION For DTLs, issuing a false or fraudulent drug test result may be grounds for suspension or revocation of license. BRUGIAWALYST and head of the Iab who issue false / fraudulent drug test results knowingly, wilfully, or through gross negligence, shall suffer the penaly of imprisonment from 6 years and 1 day to 12 years with the fine 100,000 - 500,000 Medical Technology Laws and Bioethics xixMedical Technology Laws and Bioethics UNIT 10 Te eR eases es e=y An english scientist and physicist who was the first to demonstrate in 1781 that water is composed of ‘oxygen and hydrogen, ‘* Code on Sanitation of the Philippines ‘© Approved on December 23, 1975 > Primary law that mandates the accreditation of water analysis laboratories. ‘© Philippine Clean Water Act of 2004 ‘© Approved on March 22, 2004 > Law with the aim of maintaining and safeguarding water quality. > Monitor the quality services of water testing laboratories in the Philippines. > Rules and Regulations governing the accreditation of Laboratories for Drinking water analysis. > Excludes laboratories for academic training and/or research and other laboratories performing in-house Classifications 1. As to ownership a, Government laboratories - operated and maintained, partially or wholly by the government. b. Private laboratories - owned, established, and operated by an individual, corporation, association, or organization 2.As to institutional character —a laboratory that is, located within the premises and operates as part of an institution (e.g. hospital, medical facilities for overseas workers and seafarers). b. Freestanding laboratories — a laboratory that is located outside the premises of an institution and ‘operates independently. It shall have a minimum of 20, sqm workspace requirement. Medical Technology Laws and Bioethics 3. As to service capability a. Bacteriological analysis laboratories - detect and estimate bacterial coliform organisms in the water sample. b. Biological analysis laboratories - detect and estimate biological organisms such as plankton in the water sample. c. Physical analysis laboratories -measure aesthetic characteristics of the water sample. d. Chemical analysis laboratories -detect and estimate the levels of chemical substances in the water sample. e. Radiological analysis laboratories detect and estimate the radioactive contaminants in the water sample. Determination of gross alpha and gross beta. Philippine National Standard for Drinking Water (PNSDW) of 2017 = Ail water samples for regulatory purposes shall be examined only in DOH- accredited laboratories. Philippine Nuclear Research Institute (PNR!) “> Examination of water samples for radiological quality shall be done by the PNRI Accreditation ‘© Accreditation is a formal authorization issued by the DOH to an individual, partnership, corporation, or association seeking to perform drinking water analysis in compliance with the requirements provided by the DOH. ‘* Laboratories of drinking water analysis are required to, register with the HFSRB, and no laboratory shall operate without any valid Certificate of Accreditation (COA) Center for Health Development (CHD) ‘* Responsible for the renewal of the accreditation, ‘* conduct proficiency testing confirmatory testing, and personnel training relative to the accreditation of laboratories for drinking water analysis ‘* NRL for drinking water analysis, xxMedical Technology Laws and Bioethics GUIDELINES FOR COA: 1. The COA is valid for two years and expires on the last day of December stated in the certificate. Failure to apply for renewal of accreditation within 60 days of the expiration date will result in lapse of accreditation and cancellation of registration. 2. The 3, A separate COA Is required for all laboratories or branches maintained on separate premises but operated under the same management, 4. The 5A Licensed sanitary engineer ‘ Clinical pathologist (if the laboratory is attached to a licensed clinical laboratory) «If there is no available licensed sanitary engineer > Licensed chemist Registered medical technologi > Registered pharmacist Registered medical technologist ‘ Registered pharmacist «Licensed chemist ‘© Microbiologist ‘In the aforesaid administrative order, management and ‘supervision of laboratories for drinking water analysis carried out by a licensed sanitary engineer unless the laboratory is attached to a licensed clinical laboratory. The analyst in charge of the official laboratory report and the head of the laboratory are the only individuals. authorized to sign the official water Analysis report. Medical Technology Laws and Bioethics Laboratory report Alll laboratory reports must have accurate test results and shall bear the names of the head of the laboratory, analyst and testing facility. 2. must affix their signatures in all laboratory reports prior to issuance 3. Laboratory reports for chemical analysis shall be Certified by the registered chemist and shall bear the registered chemist’s seal or the seal ofthe registered chemist 4 For outsourced tests, the issued resuits shall be that of the referral LDWA 5. AllLDWA reports shall include all the information prescribed by the DOH 6. XxMedical Technology Laws and Bioethics UNIT II ‘+ What is Bioethics? Bioethics is a philosophical discipline that deals with the study of the morality of human conduct in relation to health in particular and to human life in general" ‘+ What are the basic and major bioethical principles? > To fully carry out the corpus of bioethics in addressing bioethical issues, the basic, as well as the major bioethical principles, must be taken into consideration. ~ To safeguard its full implementation, these bioethical principles now form part of the Revised Code of Ethics {or Medical Technology, Medical Technology Oath, and laws affecting the practice of medical technology. Basic principles 1, Stewardship Principle, 2, Totality Principle. 3. Double Effect Principle, and 4. Principle of Cooperation: ‘¢ Stewardship Principle embodies the concept that a steward has the obligation to take good care and improve a thing or asset entrusted to him/her From a. medical standpoint, humans are entrusted with their bodies and have the obligation to preserve and develop it + Totality Principle -means that the parts of the physical entity, as parts, are ordained to the good of the physical whole. ‘Moral teachings can be reduced as follows: 1, The patient should have a serious need that can only be satisfied by organ donation. 2, Even if donation reduces “anatomical integrity, it should not diminish the functional integrity of the person 3, The risk in donation as "an act of charity is [to be] proportionate to the good resulting for the recipient” 4, There should be “free and informed consent" by the donor 4. contemplates that itis permissible to cause harm as. a side effect (or "double effect") of bringing about a good result even though it would not be permissible to cause such a harm as a means to bringing about the same good end. Medical Technology Laws and Bioethics Four conditions in applying this principl 1. That the action in itself from its very object be good or at least indifferent 2. That the good effect and not the evil effect be intended 3. That the good effect be not produced by means of the evil effect 4. That there be a proportionately grave reason for permitting the evil effect + BHIRIIB/GH ECSBESERHGE- is a bioethical concept that differentiates the action of the wrongdoer from the action ofthe cooperator There are two types: 1. Formal cooperation is defined as willing participation cn the part of the cooperative agent in the sinful act of the principal agent” 2. Material cooperation occurs when the cooperator does not intend the object of the wrongdoer's activity but actively participates in the deed by which evil is performed, + Principle of Respect for Autonomy-entails that health-care professionals should respect the autonomous decisions of competent adults The word autonomy comes from the Greek autos-nomos meaning “celFrule” or “self-determination.” ® Principle of Beneficence- holds that health care should alm to do good. ¢ Principle of Non-maleficence- requires that health care professionals should do no harm > This concept is found in the instructions of the Hippocratic Oath, viz "pronum non nocere" (first, do no harm) Harm or injury may be committed maliciously (dolo) or by means of fault (culpa). Resulting acts from fault or culpa are negligence and imprudence. - Brine BF JUBHIES holds that health-care professionals should act fairly when the interests of diferent individuals or gtoups are in competion XxIlMedical Technology Laws and Bioethics ‘There are two types of Principle of Justice ‘* Comparative justice refers to balancing the ‘competing interests of individuals and groups against ‘one another.” « Distributive justice refers to the fair distribution of health-care services to all Professional Ethics Professional ethics is concemed with the standards and moral conduet that govern a profession and its members HealthCare Ethics > Health-care ethics is the field of applied ethies that ‘encompasses the vast array of moral decision-making situations that arise in the practice of medicine in addition to the procedures and the policies that are designed to guide such practice.” Official professional ethics for medical technology > The Revised Code of Ethies for Medical Technology was enacted on March 7, 1997 serves as the basis of the professional ethics of the profession. ‘A PROFESSIONAL CODE OF ETHICS, DUTIES, AND RESPONSIBILITIES OF MEDICAL TECHNOLOGIST > The Revised Code of Ethies of Medical Technology outlines the duties, responsibilities, and obligations of a medical technologist to his/her patient, to the public, and to the and profession I shall Accept the responsibi being a professional: law and shall not participate in illegal it of fairness to all and ina spirit of brotherhood toward other members of the profession; ‘* accept employment from more than one employer only when there is no conflict of interest; perform my task with full confidence absolute reliability, and accuracy: ‘¢ share my knowledge and expertise with my colleagues, contribute to the advancement of the professional organization and other health allied organization: « restrict my praises, criticisms, in constructive |i «treat any information | acquired in the course of my work as strictly confidenti jews, and opinions Medical Technology Laws and Bioethics ‘© uphold the dignity and respect of my profession and conduct myself a reputation of reliability, honesty, and integrity; ‘* be dedicated to the use of clinical laboratory science to promote life and benefit mankind; ‘* report any violation of the above principles of the professional conduct to authorized agency and to the ethics committee of the organization ‘* The 1987 Philippine Constitution ‘* Laws (RA. No. 5527, the Revised Penal Code the Civil Code of the Philippines, the Family Code of the Philippines, Labor Code) and their respective implementing rules ‘ Jurisprudence ‘= Bioethical principles 1. Negligence vs. Imprudence > Imprudence indicates a deficiency ofaction. Negligence points to a eficiency of perception. Negligence usually involves lack of foresight. Imprudence usually involves lack of skill 1. A duty of the health-care provider to his/her patient 2. The health-care provider breaches this duty 3. Injury to the patient 4, Proximate causation between the breach and the injury suffered > Res ipsa loquitur literally translates to “the thing speaks for itself In order to allow to resort to the doctrine, therefore, the following essential requisites must first be satisfied: a. The accident was of a kind that does not ordinarily occur unless someone is negligent. b. The instrumentality or agency that caused the injury was under the exclusive control of the person charged. c. The injury suffered must not have been due to any voluntary action or contribution of the person injured XXIILMedical Technology Laws and Bioethics Criminal Liabilities > A medical technologist may also be criminally liable if he/she commits or omits an act treated by the law as a ‘crime. Crime is a generic term; thus, ifa crime is Punishable by the Revised Penal Code, the crime is called a felony, but if the crime is penalized by other special penal laws, itis called an offense. Bioethical issue A bioethical issue is an ethical dispute that requires the application of ethical principles for its resolution. > The resolution of every biological issue calls for ‘complementary standing of “fe” (pro-life) on one hand and "choice" (pro-choice) on the other. ‘The following are well-worn bioethical issues: ~ Refers to the expulsion of a human fetus before the period of viability. Classifications of the Expulsion of Human Fetus: ‘Direct Abortion ~ intentionally or deliberately done, the termination of pregnancy constitutes direct abortion ‘ Indirect Abortion ~ unintentionally, the expulsion may constitute indirect abortion that is, the fetus is aborted indirectly * Spontaneous Abortion ~ accidentally occurs, the expulsion of the fetus makes Up spontaneous abortion ‘* Comes from the Greek word, "thanatus” which means “easy or happy death. “Easy death’ earlier death that is intentionally caused in order to get rid of a ‘difficult death’ * Active euthanas > Positive act of causing death > A measure necessary to end the life of a suffering person is directly used > Example: a lethal dose is injected into the terminally ill patient to cause immediate death * Passive euthanasia > Negative act of causing death > measure necessary to sustain the life of a suffering person is omitted, withheld or withdrawn Medical Technology Laws and Bioethics > Example: food and water are withdrawn to bring about the earlier death of a terminally ill patient ‘@ Organ Transplantation Organ transplantation is a form of surgery wherein one body partis transferred from one site to another or rom one individual to another. Tissue transplanted from one part of he body to another in the same individual is called autograph or autotransplant. ~ The transplant of an organ or tissue from one individual to 364 another is called allograph or homograph. A surgical graft of tissue from animals 343 to humans is called xenograph or heterograph. XXIV