MEDICAL TECHNOLOGY LAWS & BIOETHICS

MTAP 1 || UERM – MT 2022

MEDTECH LAWS SUMMARY PAMET PRESIDENTS

LAW TITLE APPROVED DATE Term President Advocacy
R.A. No. 7722 Higher Education Act of 1994 May 18, 1994 Charlemagne T. Emergence of the Profession
1963-1967
Philippine Modernization Act of Tamondong
R.A. No. 8981 December 5, 2000
2000 1967-1970 Nardito D. Moraleta Professional Recognition
Philippine Medical Technology 1970-1971 Felix E. Asperer Legislative Agenda
R.A. No. 5527 June 21, 1969
Act of 1969 1971-1973 Bernardo T. Tabaosares Celebration of the Profession
Continuing Professional 1973 Angelina R. Jose Career Advocacy
RA No. 10912 June 21, 2016
Development Act of 2016 1977-1981 Venerable Oca Educational Enhancement
RA No. 4688 Clinical Laboratory Law June 18, 1966 1982-1991 Carmencita P. Acedera Image Building
National Blood Services Act of 1992-1996 Marilyn R. Atienza Proactivism
RA No. 7719 May 55, 1994
1994 1997-2000 Norma N. Chang International Leadership
Philippine HIV and AIDS Policy 2001-2002 Agnes B. Medenilla Organizational Dynamism
RA No. 11166 December 20, 2002
Act 2003-2004 Shirley F. Cruzada Interdisciplinary Networking
Comprehensive Dangerous 2005-2006 Agnes B Medenilla Organizational Dynamism
RA No. 9165 January 23, 2002
Drugs Act of 2002 2007-2013 Leila M. Florento Global Perspective
RA No. 9288 Newborn Screening Act of 2004 April 7, 2004 Romeo Joseph J. Golden Celebration
Code on Sanitation of the 2013-2015
Ignacio
P.D. No. 856 December 23, 1975
Philippines 2015-2020 Rolando E. Puno Empowerment
Philippine Clean Water Act of 2021-Present Rommel F. Saceda
RA No. 9275 March 22, 2004
2004
RA No. 7170 Organ Donation Act of 1991 January 7, 1997
RA No. 10173 Data Privacy Act of 2012 August 26, 2012
Mandatory Reporting of Philippine Association of Schools of Medical Technology
Notifiable Diseases and Health & Public Health
RA No. 11332 April 26, 2019
Events of Public Health Concern
▪ PASMETH is the national organization of all
Act
recognized schools and colleges of Medical
Technology and Public Health in the
HISTORY OF MEDICAL TECHNOLOGY Philippines
▪ Organized: MAY 12, 1970
▪ Laboratorio Municipal de Manila
1887 ▪ GUSTAVO REYES – 1st president
- Under Spanish regime
1927 ▪ UP offered its B.S. in Hygiene and Public Health
1939 ▪ Department of Health was created PASMETH LOGO
▪ 26th Medical Laboratory of the 6th US Army Circle Continuity of learning and the never-ending quest for
1945 excellence in the field of academe.
- World War II
▪ Philippine Union College (Willa Hilgert Hedrick) Diamond Objectives of association
1953 Microscope Field of Medical Technology and Public Health
- Known today as Adventist University of the Philippines
1955 ▪ Jesse Umali – first graduate of BSMT
▪ R.A. No, 5527 - Medical Technology became a regulated OTHER PASMETH PRESIDENTS
JUNE Dr. Ibarra Panopio
profession in the Philippines. 1
21,
- Board exam became mandatory in order to be registered 2 Dr. Angelita Adaya
1969
/ authorized to practice MedTech. 3 Dr. Elizabeth Del Rio (2 term)
4 Dr. Gustavo Reyes (2 term)
5 Dr. Norma Lerma
Philippine Association of Medical Technologists, Inc. 6 Dr. Vivensio Torres
▪ SEPTEMBER 15, 1963 7 Mr. Nardito Moraleta
▪ It is the organization of all registered medical 8 Mrs. Norma Chang
technologists in the Philippines 9 Prof. Rodolfo Rabor
▪ Organized by MR. CRISANTO GOMEZ ALMARIO Dr. Nini Lim
10
 Father of PAMET 11 Mrs Zenaida Cajucom
▪ Officially recognized as the only Accredited
12 Bernard U. Ebuen (Incumbent President)
Professional Organization (APO) of registered
Medical Technologists in the Philippines.
▪ “My Beloved PAMET”- Hector Gayares, Jr (lyrics) & Francis Pefanco
(music)
The Philippine Society of Medical Technology Students
▪ Special program of the Student Development
PAMET LOGO
Committee of the Philippine Association of
Circle Symbolizes the continuous involvement where practice and Schools of Medical Technology and Public
education must always be integrated Health (PASMETH)
Triangle The trilogy of Love, Respect and Integrity ▪ Serve as a transforming venue for the
Green The color of health integral and holistic development of Medical
Microscope Symbolize the science of Medical Technology Profession Technology/Medical Laboratory Science students
& Snake
1964 Year of First PAMET election
PHISMETS LOGO
3 Circle Continuous active involvement of Luzon, Visayas and
Mindanao to the national transforming venue of
Medical Laboratory Science Students.
Laurel Nature and the continuation of Life every year.
Green The color of health
5 Bubbles from Nature and the continuation of Life every year.
Test Tube
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 MTAP 1 || MEDICAL TECHNOLOGY LAWS AND BIOETHICS || RMT 2022
15 Unity of the 15 Board Schools exploring various
Interconnected possibilities and aiming towards the integral growth REPUBLIC ACT NO. 7722
Molecules and holistic development of Medical Laboratory Science HIGHER EDUCATION ACT OF 1994
Students AN ACT CREATING THE COMMISSION ON HIGHER EDUCATION,
Microscope Signifies Medical Laboratory Scienc APPROPRIATING FUNDS THERFOR AND FOR OTHER PURPOSES
Title “HIGHER EDUCATION ACT OF 1994”
Approved date MAY 18, 1994
CHED PRC ▪ Created the Commission on Higher Education (CHED)
Law R.A. 7722 R.A. 8981 ▪ Term of Office: 4 YEARS
Subj. An act creating the Commission An act modernizing the ▪ Important Function:
Matter on Higher Education, professional regulation ▪ “Set the minimum standards for programs and institutions
appropriating funds thereof and commission, repealing for the of higher learning recommended by panels of experts in the
for other purposes purpose presidential decree field and subject to public hearing and enforce the same.”
numbered two hundred and ▪ Also created TECHNICAL PANELS
twenty three, entitled "Creating
▪ The ad hoc recommendatory bodies to the CHED on the
The Professional Regulation
Commission And Prescribing Its setting of minimum standards for the programs and
Powers And Functions," and for institutions of higher learning.
other purposes
DOA May 18, 1994 December 5, 2000 CHED MEMORANDUM ORDER No, 13 Series of 2017
Title “Higher Education Act of “Philippine Modernization POLICIES, STANDARDS AND GUIDELINES FOR THE BACHELOR OF SCIENCE
1994” Act of 2000” IN MEDICAL TECHNOLOGY/ MEDICAL LABORATORY SCIENCE (BSMT/MLS)
Sections 21 sections 21 sections PROGRAM
Compo- Five (5) full-time members (1- Five (5) full-time members (1- Approved Date MAY 8, 2017
sition Chairman and 4- Chairman and 4- The degree program shall be called
commissioners) commissioners) Program
“Bachelor of Science in Medical Technology/
Term of Specification
4 years 7 Years Bachelor of Science in Medical Laboratory Science”
Office
▪ BSMT/BSMLS is a four-year program consisting of
Quali. 1. Holders of earned doctorate(s) 1. At least forty (40) years of
2. Who have been actively age;
general education and professional courses
engaged in higher education for 2. Holding a valid certificate of Nature of the ▪ The fourth-year level is the internship program of
at least ten (10) years; registration/professional Field of Study one (1) year in a CHED0-acredited training
3. Must not have been candidates license; laboratory with rotational duties in different
for elective positions in the 3. Familiar with the principles sections.
elections immediately and methods of professional
preceding their appointment; regulation and/or licensing; DISCIPLINE NO. OF HOURS
4. They shall be academicians and Clinical Chemistry 300
known for their high degree of 4. Has had at least five (5) years
professionalism and integrity of executive or management Analysis of Urine and Body Fluids (Clinical
200
who have distinguished experience. Microscopy) & Parasitology
themselves as authorities in Microbiology 250
their chosen fields of learning Hematology 300
Bodies PRC (PRBs are created by Blood Banking 200
Created CHED and Technical Panels
specific regulatory laws) Histopathologic Technique and Cytology 100
Coverage Immunology & Serology 220
of appli- Pre-licensure Licensure and post- licensure
cability
Laboratory Management (Collection, Handling,
Transport and Receiving of Specimen, Quality 40
CHED LOGO Assurance, Safety and Waste Management)
Representation of how Philippine Higher Education Evolved Phlebotomy 54
Ideal three-level, manpower structure of the country, Total 1664 hours
comprising of basic level skills, middle or semi-skilled
workers, and high or professional levels of human resource Addt’l notes:
located at the apex of the pyramid and the primary concern The intern should render 32 internship duty hours per week for 52 weeks:
PYRAMID
of higher education. ▪ Two 8-hour regular duty per week = 16 hours
▪ Human silhouette inside the pyramid – human ▪ One 16-hour duty per week = 16 hours
resources development of every Filipino to become ▪ 32 hours per week x 52 weeks = 1664 hours
productive citizens of the country.
RISING Dawning of a new era in higher education with the creation Review Question:
SUN of CHED. What is the duration of the internship?
Red, Yellow and Blue – correspond to the colors of the a. 12 months
COLOR
Philippine flags as CHED was created to be the main b. 1664 hours
TRIAD
advocate and pillar of nation building c. 52 weeks
Year when CHED was created by law. On May 18, 1994, d. 1 year
1994 CHED was established through Republic Act No. 7722, e. All of the above
otherwise known as the “Higher Education Act 1994”

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REPUBLIC ACT NO. 8981 SEC. 9 Executive Officer of the Board
PROFESSIONAL REGULATION COMMISSION Compensation of Members of the Board of Examiners for
SEC. 10
AN ACT MODERNIZING THE PROFESSIONAL REGULATION COMMISSION, Medical Technology.
REPEALING FOR THE PURPOSE PRESIDENTIAL DECREE NUMBERED TWO SEC. 11 Functions and Duties of the Board.
HUNDRED AND TWENTY-THREE (P.D. 223), ENTITLED "CREATING THE SEC. 12 Removal of Board Members.
PROFESSIONAL REGULATION COMMISSION AND PRESCRIBING ITS
POWERS AND FUNCTIONS," AND FOR OTHER PURPOSES Accreditation of Schools of Medical Technology and of
SEC. 13
Title “PRC MODERNIZATION ACT OF 2000” Training Laboratories.
Approved date DECEMBER 5, 2000 SEC. 14 Inhibition Against the Practice of Medical Technology.
Composition The commission shall be headed by:
1. One (1) full-time Chairperson SEC. 15 Examination
2. Two (2) full-time Commissioner SEC. 16 Qualification for Examination.
SEC. 17 Scope of Examination.
Term of Office: 7 YEARS
▪ Appointed by the President of the Philippines SEC. 18 Report of Rating.
▪ Without reappointment to start from the time they assume office SEC. 19 Rating in the Examination.
SEC. 20 Oath Taking.
POWERS, FUNCTION AND RESPONSIBILITIES OF PRC SEC. 21 Issuance of Certification Registration.
1. Regulation and licensing of the various professions and occupations
SEC. 22 Fees
under its jurisdiction.
SEC. 23 Refusal to Issue Certificate.
2. Administer and conduct the of licensure examinations.
SEC. 24 Administrative Investigation.
3. Determine and fix the places and dates of examinations.
SEC. 25 Appeal
4. Authorized to require the completion of a refresher course where the
examinee has failed to pass three (3) times. SEC. 26 Reinstatement, Reissue or Replacement of Certificate.
5. Approve the results of examinations and the release of the same.
6. Adopt measures to preserve the integrity and inviolability of licensure SEC. 27 Foreign Reciprocity.
examinations. SEC. 28 Roster of Medical Technologist.
7. Admit the successful examinees to the practice of the profession or SEC. 29 Penal Provisions.
occupation. SEC. 30 Separability Clause.
8. Custodian of all the records of the various boards. SEC. 31 Repealing Clause.
9. Monitor the performance of schools in licensure examinations and SEC. 32 Effectivity
publish the results thereof in a newspaper of national circulation.
10. Supervision of PRBs (MTB) AMENDMENTS MADE
LAW SECTION DATE
PROFESSIONAL REGULATORY BOARD R.A. 6138 Sec. 16, 21, 22 August 31, 1970
The official PRB of Medical Technology is the “Medical Technology Board” Sec. 2, 3, 4, 7, 8, 11, 13, 16,
P.D. 498 June 28, 1974
17, 21, 29
R.A. 8981 P.D. 1534 Sec. 3, 8, 11, 13 June 11. 1978
Expanded the power of the authority of the Medical Technology Board
SECTION
POWERS, FUNCTION AND RESPONSIBILITIES OF MT BOARD The following Sections were amended
2, 4, 7, 13, 17, 22, 29
1. To regulate the practice of the professions in accordance with the once
provisions of their respective professional regulatory laws. The following Sections were amended
3, 8, 11, 16, 21
2. To hear and investigate cases arising from violations of their twice
respective laws, the rules and regulations. 1, 5, 6, 9, 10, 12, 14, 15, 19,
3. After due process, to suspend, revoke or reissue, reinstate certificate The following Sections were not amended 20, 23, 24, 25, 26, 27, 28, 30,
of registration or licenses for causes provided by law. 31, 32
4. To determine and prepare the questions for the licensure
examinations. SECTIONS
5. To score and rate the examination papers; and
6. To submit the results in all subjects duly signed by the members of SECTION 1: TITLE
the Board to the Commission within ten (10) days from the last day This act may also be called as the “Philippine Medical Technology Act of
1969”

SECTION 2: DEFINITION OF TERMS

REPUBLIC ACT NO. 5527 As used in this Act, the following terms shall mean:
PHILIPPINE MEDICAL TECHNOLOGY ACT OF 1969 a. Practice of Medical Technology - A person shall be deemed to be in
AN ACT REQUIRING THE REGISTRATION OF MEDICAL TECHNOLOGIST, the practice of medical technology within the meaning of this Act,
DEFINING THEIR PRACTICE, AND FOR OTHER PURPOSES who shall for a fee, salary or other compensation or reward paid or
Title “PHILIPPINE MEDICAL TECHNOLOGY ACT OF 1969” given directly or indirectly through another, renders any of the
Approved date JUNE 21, 1969 following professional services for the purpose of aiding the physician
in the diagnosis, study and treatment of diseases and in the
promotion of health in general:
PROVISIONS OF R.A. 5527 as Amended
1. Examination of tissues, secretions and excretions of the human
SEC. 1 Title
body and body fluids;
SEC. 2 Definition of Term
2. Blood banking procedures and techniques;
3. Parasitological, Mycologic and Microbiologic procedures and
SEC. 3 Council of Medical Technology Education, Its Composition techniques;
SEC. 4 Compensation and Travelling Expenses of Council Members 4. Histopathologic and Cytotechnology;
SEC. 5 Function of the Council of Medical Technology Education 5. Clinical research;
6. Preparations and standardization of reagents, standards, stains
SEC. 6 Minimum Required Course and others, provided such reagents, standards, stains and
SEC. 7 Medical Technology Board others are exclusively for the use of their laboratory;
SEC. 8 Qualification of Examiners 7. Clinical laboratory quality control; and
8. Collection and preservation of specimens.

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b. Pathologist – A duly registered physician who is specially trained in Philippine Association of Medical Technologists
methods of laboratory medicine, or the gross and microscopic study
and interpretation of tissues, secretion and excretions of the human Compensation and Travelling Expenses of Council
SECTION 4
body and its functions in order to diagnose disease, follow its course, Members
determine the effectivity of treatment, ascertain cause of death and SECTION 5 Function of the Council of Medical Technology Education
advance medicine by means of research.
▪ There are two types of pathologists: Technical Panel and
 Clinical pathologists are medical specialists who direct Council of Medical Technical Committee of
most of the divisions in a clinical laboratory. Technology Education Medical Technology
 Anatomic pathologists are concerned with the Education
diagnosis of disease through examination of Council is created by R.A. No. Technical Panels are created
specimens derived from surgical procedures. 5527 (Section 3) on June 21, by R.A. No. 7722 (Section 12)
Manner
 Molecular pathologist of 1969 on May 18, 1994
Creation
c. Medical Technologist – A person who engages in the work of medical Created by specific law Created by
technology under the supervision of a pathologist or licensed The compositions of the
physician authorized by the Department of Health in places where The composition of the
Compo- Technical Panels and
there is no pathologist and who having passed the prescribed course council is expressly provided
sition Committee are appointed by
(Bachelor of Science in Medical Technology/Bachelor of Science in by the law
the CHEd
Hygiene) of training and examination is registered under the provision The Office of the Chairman,
of this Act. Vice-Chairman, and Council
Term of
Members hold their Ad hoc appointment
d. Medical Laboratory Technicians – A person certified and registered Office
respective under exofficio
with the Board as qualified to assist a medical technologist and/or capacity.
qualified pathologist in the practice of medical technology as defined
Expressly provide under
in this Act
Expressly provide under Section 12 of RA 7722 and
Addt’l Notes: Function
Section 5 of RA 5527 their respective appointment
Under “Practice of Medical Technology” papers
Question 1: Med. Tech. “A” received a laboratory request from Dr. Strange
for complete blood count (CBC). Med. Tech. “A” immediately proceeded to SECTION 6: MINUMUM REQUIRED COURSE
the patient’s room and withdrew a blood specimen. Then, he processed Minimum Required Course
the blood for the test requested. Do you consider the activity of Med. ▪ The medical technology course shall be at least four years, including
Tech. “A” as a professional service of med. tech. profession? a 12-month satisfactory internship in accredited laboratories. (CMO
No. 13 Series of 2017)
Answer: Yes. CBC is a hematologic procedure. Hematologic procedure and
collection of blood specimen are among the enumerated professional In order for a clinical laboratory to be considered as training laboratory
services of medical technology profession. (see paragraphs 1 and 8) the following must be present:
a. The training laboratory must be a tertiary clinical laboratory
Question 2: Med. Tech. “A” prepared a 10% formalin by mixing nine parts b. The clinical laboratory must be accredited with the HFSRB of the
of distilled water and one part of aqueous formaldehyde. Then after, Med. DOH;
Tech. “A” sold the 10%formalin solution to another laboratory. Do you c. The training laboratory must be accredited with the CHEd
consider the activity of Med. Tech. “A” as a professional service of med.
tech. profession? As a general rule, the internship program must be conducted in an
accredited tertiary category institution-based Clinical Laboratory.
Answer: No. in order to consider the activity of Med. Tech. “A” within the
contemplation of professional service of med. tech. profession, the 10% As an , in areas where there is no or where there are limited number of
formalin must be for the exclusive use of their laboratory. (see paragraph tertiary category institution-based Clinical Laboratories, affiliation of
6) interns can be carried out in an accredited tertiary category free standing
laboratory
Question 3: Med. Tech. “A” released the HIV result. Upon release, Med.
Tech. “A” interpreted the laboratory result to the patient in reference to SECTION 7: MEDICAL TECHNOLOGY BOARD
the signs and symptoms of the former. Med. Tech. “A” even prescribed a Medical Technology Board
retroviral drug to control the patient’s viral load. Do you consider the ▪ There is hereby created a Medical Technology Board under the
activity of Med. Tech. “A” as a professional service of med. tech. Professional Regulation Commission, which shall thereafter be
profession? referred to as the Board composed of a Chairman who is a
pathologist, and two (2) members who are registered medical
Answer: No. Interpretation of laboratory result and prescription of drug technologists who shall be appointed by the President of the Republic
are not among the enumerated professional services of medical of the Philippines upon recommendation of the Professional
technology profession. (See paragraphs 1 to 8) Regulation Commission.
▪ The Chairman and members of the Board shall hold office for three
SECTION 3: COUNCIL OF MEDICAL TECHNOLOGY EDUCATION, ITS (3) years after appointments or until their successors shall have been
COMPOSITION appointed and duly qualified:
There is hereby established a Council of Medical Technology Education, ▪ Provided, that the incumbent members will continue to serve until
referred to as Council, which shall be composed of: the expiration of their terms.
▪ Chairman – Director of Higher Education ▪ In case of death, disability, or removal of a member of the Board, his
▪ Vice Chairman – Chairman of the Professional Regulation successor shall serve only the balance of his term.
Commission (PRC)
Members: Composition of Medical Technology Board:
▪ Director of the Bureau of Research and Laboratories of the a. Chairman who is a pathologist;
Department of Health b. Two (2) members who are registered medical technologists
▪ Chairman and two (2) members of the Board of Medical
Technology  Appointed by the President of the Republic of the Philippines upon
▪ A representative of the Deans of Schools of Medical Technology recommendation of the Professional Regulation Commission.
and Public Health  Term of Office: Three (3) years
▪ Presidents of the Philippine Society of Pathologists and the

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 MTAP 1 || MEDICAL TECHNOLOGY LAWS AND BIOETHICS
Other notes:
The first Board was composed of:
▪ Chairman: Dr. Arturo D. Tolentino, Jr
▪ Members: Mr. Felix E. Asprer and Ms. Azucena S. J. Vizconde
Example:
Question: Meng is the Chairman of MTB. He only served one (1) year
because he died due to myocardial infarction. Lizzie, a registered medical
technologist, was appointed as Chairman of MTB by the Chairperson of
PRC to serve for three (3) years. Is the appointment valid?
a. No, the appointment is invalid because officers of MTB shall be
appointed by the President of the Republic of the Philippines,
and not the Chairperson of the PRC.
b. No, the appointment is invalid because the newly appointed
officer of MTB shall only serve the unexpired portion of his
predecessor, in this case, only two (2) years.
c. No, the appointment is invalid because the Chairman of MTB
must be a qualified pathologist, not a medical technologist.
d. All of the above choices
SECTION 8: QUALIFICATION OF EXAMINERS
Qualifications of Examiners
No person shall be appointed as member of the Board of Examiners for
Medical Technology unless he or she is (1) is a Filipino citizen; (2) is of
good moral character; (3) is a qualified Pathologist, or a duly registered
medical technologist of the Philippines with the degree of Bachelor of
Science in Medical Technology/Bachelor of Science in Hygiene/Public
Health; (4) has been in practice of laboratory medicine or medical
technology for at least ten years prior to his appointment, and (5) is not a
member of the faculty of any medical technology school for at least two
years prior to appointment or having any pecuniary interest direct or
indirect in such institution: Provided, however, That for the first three
years following the approval of this Act, the requirements mentioned in
number four (4) shall be reduced to five years.
Other notes:
Qualifications of MTB:
(1) he or she is a Filipino citizen;
(2) he or she is of good moral character;
(3) he or she is a qualified Pathologist, or a duly registered medical
technologist of the Philippines;
(4) he or she has been in practice of laboratory medicine or medical
technology for at least 10 years prior to his appointment, and
(5) he or she is not a member of the faculty of any medical technology
school for at least two (2) years prior to appointment or having any
pecuniary interest direct or indirect in such institution
SECTION 9 EXECUTIVE OFFICER OF THE BOARD
COMPENSATION OF MEMBERS OF THE BOARD OF
SECTION 10
EXAMINERS FOR EMDICAL TECHNOLOGY
SECTION 11: FUCTION AND DUTIES OF THE BOARD
The Board is vested with authority and required, conformably with the
provisions of this Act, to:
 Administer the provisions of this Act
 Administer oaths in connection with the administration of this Act
 Issue, suspend and revoke certificates of registration for the
practice of medical technology and medical laboratory technician
 Look into conditions affecting the practice of medical technology in
the Philippines and, whenever necessary, adopt such a measure
may be deemed proper for the maintenance of good ethic and
standards in the practice of medical technology
 Investigate such violations of this Act or of the rules and regulations
issued thereunder as may come to the knowledge of the Board and,
for this purpose issue subpoena and subpoena duces tecum to
secure appearance of witnesses and production of documents in
connection with charges presented to the Board; and
 Draft such rules and regulations as may be necessary to carry out
the provisions of this Act: Provided, that the same shall be issued
only after the approval of the President of the Philippines;
 Determine the adequacy of the technical staff of all clinical
laboratories and blood before they could be licensed with the
Department of Health in accordance with R.A. No. 4655 and 1517;
 Prescribe the qualifications and training of medical technologists as
to special fields of the profession and supervise their specialty
examination conducted by the professional organization of medical
technologists accredited by the Professional Regulation
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Commission
 Classify and prescribe the qualification and training of the technical
staff of clinical laboratories as to:
▪ Medical Technology
▪ Medical Technologist
▪ Senior Medical Technologist
▪ Medical Technologist and Medical Laboratory Technician
Function of the MTB can be classified as
Concerned with the work of applying policies and
enforcing orders as determined by proper
Administrative governmental organs, in this case the MTB.
▪ Ex: Subsections “a,” “b,” “g,” “h” and “i” of
Section 11, R.A. No. 5527
Otherwise known as the “rule-making power”
▪ The power to make rules and regulations
Quasi-
which results in delegated legislation.
Legislative
▪ Ex. Subsections “d,” and “f” of Section 11, R.A.
No. 5527
The power to hear and determine questions of fact to
which the legislative policy is to apply and to decide in
accordance with the standards laid down by the law
Quasi-Judicial
itself in enforcing and administering the same law.
▪ Ex. Subsections “c,” and “e” of Section 11, R.A.
No. 5527
SECTION 12: FUCTION AND DUTIES OF THE BOARD
Any member of the Board may be removed by the President of the
Philippines for neglect of duty, incompetency, malpractice or
unprofessional, unethical, immoral or dishonorable conduct after having
been given opportunity to defend himself in a proper and administrative
investigation:
▪ Provided, that during the process of investigation, the President shall
have the power to suspend such member under investigation and
appoint a temporary member in his place.
Requirements for removal of Board Members:
1. Removed by the President of the Philippines
2. Removed due to valid grounds (i.e. neglect of duty, incompetency,
malpractice or unprofessional, unethical, immoral or dishonorable
conduct;)
3. There is an opportunity given to the erring board member to defend
himself.
Provided, that during the process of investigation, the President shall have
the power to suspend such member under investigation and appoint a
temporary member in his place. (Concept of Preventive Suspension)
SECTION 13: ACCREDITAION OF SCHOOLS OF MEDICAL TECHNOLOGY
AND OF TRAINING LABORATORIES
Upon the recommendation of the Medical Technology Board, the
Department of Education and Culture shall approve schools of Medical
Technology in accordance with the provisions of this Act, as amended, in
conjunction with the Board of Medical Technology. The Department of
Health through the Bureau of Research and Laboratories shall approve
laboratories for accreditation as training laboratories for medical
technology students or postgraduate trainees in conjunction with the
Board of Medical Technology. In order for a clinical laboratory to be
considered as training laboratory the following must be present:
 The training laboratory must be a tertiary clinical laboratory
 The clinical laboratory must be accredited with the HFSRB of the
DOH
 The training laboratory must be accredited with the CHEd
Accreditation of Schools of Medical Technology
CHED
Accreditation of Training Laboratories
Note: A clinical laboratory must first be accredited with the HFSRB (then
BRL)
▪ If that clinical laboratory is being utilized as Training Laboratory, an
additional accreditation with the CHEd is required.
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SECTION 14: INHIBITION AGAINST THE PRACTICE OF MEDICAL of completion of the examination, report the result thereof to the
TECHNOLOGY Commissioner of Civil Service, who shall submit such result to the
President of the Philippines for approval.
No person shall practice or offer to practice medical technology as defined
in this Act without having previously obtained a valid certificate of ▪ Impliedly modified by Section 9(h) of R.A. No. 9181
registration from the Board provided that registration shall not be
Section 9(h) of R.A. No. 8981:
required of the following:
▪ Otherwise known as “PRC Modernization Act of 2000,”
▪ Duly registered physicians
▪ Provides for the functions of Professional Regulatory Boards (PRBs):
▪ Medical technologist from other countries called in for consultation
or as visiting or exchange professors to colleges or universities: (h) To prepare, adopt and issue the syllabi; determine and prepare
the questions for the licensure examinations; score and rate the
Provided, they are only practicing the said function.
examination papers; and submit the results in all subjects duly signed
▪ Medical technologists in the service of the United States Armed
by the members of the Board to the Commission within ten (10)
Forces stationed in the Philippines rendering services as such for
days from the last day of examination unless extended by the
members of the said forces only
Commission for justifiable cause/s.
General Rule: NO CERTIFICATE OF REGISTRATION, NO PRACTICE.
(Note: the PRB of Med. Tech. Profession is the MTB.
Exceptions:
a. Duly registered physicians SECTION 19: RATING OF EXAMINATION
b. Medical technologist from other countries called in for consultation In order to pass the examination, a candidate must obtain a general
or as visiting or exchange professors to colleges or universities: average of at least seventy-five percent in the written test, with no rating
Provided, they are only practicing the said function. below fifty percent in any of the major subjects: Provided, That the
c. Medical technologists in the service of the United States Armed candidate has not failed in at least sixty percent of the subjects computed
Forces stationed in the Philippines rendering services as such for according to their relative weights.
members of the said forces only ▪ No further examination will be given an applicant who has not
d. Foreign Reciprocity (section 27) – but only available to Non-Filipinos qualified after three examinations, unless and until he shall have
completed 12 months refresher course in an accredited medical
SECTION 15: EXAMINATION technology school or 12-month postgraduate training in an accredited
laboratory:
Except as otherwise specifically allowed under the provision of this Act,
▪ Provided, That graduate of paramedical profession other than
 All applicants for registration as medical technologist shall be
Bachelor of Science in Medical Technology/Bachelor of Science in
required to undergo written examination
Hygiene admitted to an examination under the provisions of this Act
 Given twice a year (every March and September)
shall not be given further examinations after the provisions of this Act
 The testing areas include Manila, Baguio, Cagayan De Oro, Cebu,
shall be given further examinations after his failure to qualify for the
Davao, Iloilo, Tacloban, Tuguegarao and Zamboanga.
third time.
 Written notices of such examination shall also be published in at
least three newspapers of national circulation by the Secretary of
Note (Summary):
the Board of least thirty days prior to the date of examination.
▪ The candidate must obtain a general average of at least 75%
SECTION 16: QUALIFICAITON FOR EXAMINATION ▪ No rating below 50% in any of the major subjects;
Every applicant examination under this Act, shall, prior to the date thereof, ▪ The candidate has not failed in at least 60% of the subjects computed
furnish the Board satisfactory proof that he or she: according to their relative weights
 In good health and is of good moral character
 Has completed a course of at least four (4) years leading to the EXAMPLE
degree of Bachelor of Science in Medical Technology or Bachelor of Subject A B C D
Science in Public Health conferred by a recognized school, college Clinical
or university in accordance with this Decree (or having graduated 69 89 71 80
Chemistry
from some other profession and has been actually performing Micro/Para 94 87 69 87
medical technology for the last five (5) years prior to the date of the Hema 74 49 74 51
examinations, if such performance began prior to June 21, 1969.) ISBB 65 98 75 87
Clinical
SECTION 16: QUALIFICAITON FOR EXAMINATION 96 85 80 81
Microscopy
Every applicant examination under this Act, shall, prior to the date thereof, HCT / MTLB 96 85 70 85
furnish the Board satisfactory proof that he or she: 79.6 81.6 72.8 77.6
 In good health and is of good moral character
 Has completed a course of at least four (4) years leading to the Student A Failed the board examination for medical technology
degree of Bachelor of Science in Medical Technology or Bachelor of because
Science in Public Health conferred by a recognized school, college ▪ He failed in Clinical Chemistry, Hematology, and Blood
or university in accordance with this Decree (or having graduated Banking and Serology (which constitute at least 60%
from some other profession and has been actually performing computed to their relative weights)
medical technology for the last five (5) years prior to the date of the
Student B Failed the board examination for medical technology
examinations, if such performance began prior to June 21, 1969.)
because
▪ His rating in Hematology, a major subject, is below
SECTION 17: SCOPE OF EXAMINATION the 50% threshold.
The examination questions shall cover the following subjects with their Student C Failed the board examination because his general average
respective relative weights: is below the 75% passing rate
Clinical Chemistry 20% Student D Passed the board examination because he obtained a
Microbiology and Parasitology 20% general average of at least 75%.
Hematology 20% ▪ He also has no rating below 50% in any of the major
Blood Banking and Serology 20% subjects, and
Clinical Microscopy (Urinalysis and other body fluids) 10% ▪ He has not failed in at least 60% of the subjects
Histopathologic Techniques, Cytotechnology, Medical computed according to their relative weights
Technology Laws, Related Laws and its implementing rules, 10%
and the Code of Ethic SECTION 20: OATH TAKING
All successful examinees shall be required to take a professional oath
SECTION 18: REPORT OF RATING before the Board or before any person authorized to administer oaths
The Board shall, within one hundred and twenty (120) days after the date prior to entering upon the practice of medical technology in the

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 MTAP 1 || MEDICAL TECHNOLOGY LAWS AND BIOETHICS
Philippines
SECTION 21: ISSUANCE OF CERTIFICATE
Every applicant who has satisfactorily passed the required examination for
medical technologist shall be issued a certificate of registration as such:
▪ Provided, that no such certificate shall be issued to any successful
applicant who has not attained the age of twenty-one (21) years.
▪ All certificate shall be signed by the members of the Board and by the
Commissioner of the Professional Regulation Commission.
Provided, that upon application filed and the payment of the required fee
of one hundred and fifteen pesos (P115.00) the Board shall issue a
certificate of registration as medical technologist without examination to
persons who have been graduated with Bachelor of Science in Medical
Technology/Bachelor of Science in Public Health in duly recognized schools
of medical technology in the Philippines or in any foreign country,
▪ Provided, that in case of the latter, the standard of medical
technology education is substantially the same as ours, and in
addition shall have been in the practice of medical technology for at
least three (3) years prior to the filing of the application in
laboratories in the Philippines duly accredited by the Bureau of
Research and Laboratories, Department of Health, or in foreign
countries if such performance began prior to June 21, 1969 and
also to all other persons who having graduated from other
professions have been actually performing medical technology
practice for the last eight (8) years prior to filing of the
application, Provided, that such performance began prior to June
21, 1969.
Provided, further, that the Board shall likewise issue a certificate of
registration as medical laboratory technician without examination to any
person who upon application and payment of the required fee of fifty
pesos (P50.00) show evidence satisfactory to the Board that:
▪ He or she passed the civil service examination for medical
technician given on March 21, 1964; or
▪ Has finished a two-year college course and has at least one (1) year
of experience as medical laboratory technician,
▫ Provided, that for every year of deficiency in college
attainment two (2) years of experience may be
substituted;
▫ Provided, further, that an applicant who has at least ten
(10) years of experience as medical laboratory technician
as of the date of approval of this Decree regardless of his
academic attainment may qualify for registration without
examination; or
▪ Has failed to pass the board examination for medical technology
but had obtained a general rating of at least 70%.
▫ Provided, finally, that a registered medical laboratory
technician when employed in the government shall have
the equivalent civil service eligibility not lower than
second grade.
SECTION 21: FEES
SECTION 23: REFUSAL TO ISSUE CERTIFICATE
The Board shall refuse to issue a certificate of registration to any person
convicted by the court of competent jurisdiction of:
▪ Any criminal offense involving moral turpitude
▪ Any person guilty of immoral or dishonorable conduct or of unsound
mind, or incurable communicable disease,
and in such shall be given to the applicant a written statement setting
forth the reason for its action, which statement shall be incorporated in
the record of the Board
SECTION 24: ADMINISTRATIVE INVESTIGATION
Revocation or Suspension of Certificates
▪ Administrative investigation shall be conducted by at least two
members of the Board with one legal officer sitting during all
administrative proceedings, the respondents shall be entitled to be
represented by counsel or be heard in person, to have a speedy and
public hearing, to confront and cross-examine witnesses against him
or her, and to all other rights guaranteed by the Constitution.
▪ The Board may, after giving proper notice and hearing to the party
concerned reprimand an erring medical technologist or revoke or
NAMP | 2022
|| RMT 2022
suspend his certificate of registration for causes mentioned in the
next preceding section or for causes enumerated in section twenty-
nine (29) of this Act, or for unprofessional conduct, malpractice,
incompetency, or serious ignorance or gross negligence in the
practice of medical technology.
No penalty of revocation shall be imposed unless there is a unanimous
vote of all the three members of the Board.
▪ The Board may, by majority vote, impose the penalty or reprimand
or suspension, the latter however not to exceed two years.
▪ When the penalty of suspension or revocation is imposed by the
Board the medical technologist shall be required to surrender his
certificate of registration within thirty days after the decision
becomes final, under the pain of perpetual disqualification from the
practice of medical technology in the Philippines for inexcusable
failure to do so.
▪ The suspension shall run from the date of such surrender.
Administrative penalties:
1. Revocation of license
2. Suspension of certificate of registration
3. Stern warning to Reprimand
Rules in imposing administrative penalties:
When Revocation is imposed, a unanimous vote of all the three
1
members of the MTB is mandatory.
When Suspension or Reprimand is imposed, a majority vote of the
2
members of the MTB will suffice.
When the penalty of Suspension is imposed, it shall not exceed two
3
(2) years.
The period of Suspension shall run from the date of such surrender
4
of certificate of registration.
When the penalty of Suspension or Revocation is imposed, the med.
tech. shall be required to surrender his certificate of registration
5
within thirty (30) days after the decision becomes final.
The Med Tech. shall also surrender his PRC Identification Card.
When the med. tech. fails to surrender his certificate of registration
within 30 days from finality of the decision, he shall be perpetually
6
disqualified in practicing medical technology in the Philippines for
inexcusable failure to do so.
SECTION 25: APPEAL
The revocation or suspension of a certificate made by the Board shall be
subject to appeal to the Civil Service Commissioner whose decision shall
become final thirty days after its promulgation, unless the respondent
within the same period has appealed to the office of the President of the
Philippines.
▪ Impliedly amended by Section 9 (c) of RA 8981
Section 9 (c) of RA 8981 provides:
▪ (c) To hear and investigate cases arising from violations of their
respective laws, the rules and regulations promulgated thereunder
and their Codes of Ethics and, for this purpose, may issue summons,
subpoena and subpoena duces tecum to alleged violators and/or
witnesses to compel their attendance in such investigations or
hearings:
▪ Provided, That, the decision of the Professional Regulatory Board
shall, unless appealed to the Commission (PRC), become final and
executory after fifteen (15) days from receipt of notice of judgment
or decision.
SECTION 26: REINSTATEMENT, REISSUE OR REPLACEMENT OF
CERTIFICATE
The Board may, upon application and for reason deemed proper and
sufficient, reissue any revoked registration certificate.
▪ The suspension of a certificate shall be re-issued to the medical
technologist concerned upon request without prejudice to further
actions by the Board for violation of the provisions of this Act or
conditions imposed by the Board upon the medical technologist
during the period of suspension.
Reinstatement COR is suspended
Replacement Lost/Destroyed
Reissuance COR is revoked
Page 7 of 17
 MTAP 1 || MEDICAL TECHNOLOGY LAWS AND BIOETHICS || RMT 2022
SECTION 27: FOREIGN RECIPROCITY REPUBLIC ACT NO. 10912
No foreigner shall be: CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016
▪ Admitted to examination
▪ Be given a certificate of registration or AN ACT MANDATING AND STRENGTHENING THE CONTINUING
▪ Be entitled to any of the rights and privileges under this Act, PROFESSIONAL DEVELOPMENT PROGRAM FOR ALL REGULATED
PROFESSIONS, CREATING CONTINUING PROFESSIONAL DEVELOPMENT
unless the country or state of which he is a subject or citizen permits COUNCIL, AND APPROPRIATING FUNDS THEREFOR, AND FOR OTHER
Filipino Medical Technologist to practice within its territorial limits on the RELATED PURPOSES
same as the subject or citizens of said country or state. Title This Act shall be called the “Continuing Professional
Development Act of 2016”.
SECTION 28: ROSTER OF MEDICAL TECHNOLOGIST Approved date JULY 21, 2016
A roster of Medical Technologist shall be prepared annually by the Description This is the law that formally requires all professionals
Secretary of the Board, commencing on the year following that in which performing regulated professions under the PRC to
this Act shall become effective. mandatorily comply with the CPD for the renewal of
▪ This roster shall contain the name, address and citizenship of each Professional identification Card (PIC).
registered Medical Technologist, date of registration or issuance of This is also the law that creates the CPD Council.
certificate, and other data which in the opinion of the Board are
pertinent. When was R.A. No. 10912 Came into law?
▪ The roster shall be open to public inspection and copies thereof shall Lapse June 21, 2016
be mailed to each person included therein, placed on file in the Office Took Effect following its
August 16, 2016
of President, furnished all Department Heads and all bureau, offices publication
and instrumentalities of the Department of Health and to such other Formally implemented by PRC March 15, 2017
offices, private or governmental, and to the public upon request.
What is the Nature of CPD?
SECTION 29: PENAL PROVISIONS CPD – A “MANDATORY REQUIREMENT” for renewal of the Professional
Without prejudice to the provision of the Medical Act of 1959 as amended Identification Cards (PIC) of all registered and licensed professionals under
relating to illegal practice of Medicine, the following shall be punished by a the regulation of PRC, including:
fine of not less than two thousand pesos nor more than five thousand ▪ Registered Medical Technologists (RMTs) and
pesos, (Php 2,000-5,000) or imprisonment for not less than six months ▪ Medical Laboratory technicians (MLTs)
nor more than two years (6 months to 2 years) or both, in the discretion
The CPD is mandatory for renewal of Professional Identification Card (PIC)
of the court
per compliance period of three (3) years. • Generally, a maximum of one
Any person who shall practice Medical Technology in the Philippines
(1) CU per hour of activity may be given. • Full credit units – given for
1 without being registered or exempted from registration in
attendance and completion of assessment.
accordance with the provisions of this Act
Any medical technologist, even if duly registered, who shall practice CPD COUNCIL
medical technology in the Philippines without the necessary The CPD Council for Medical Technology operates under the supervision of
2
supervision of a qualified pathologist or physician authorized by MTB. The following is the composition of CPD Council for Medical
the Department of Health Technology:
Any medical technologist who shall knowingly make a fraudulent A member of MTB so chosen by MTB.
3
laboratory report Chairperson ▪ Term of office: coterminous with his incumbency in
Any duly registered medical technologist who shall refuse or fail, the PRB
4 after due warning by the Board to display his certificate of President or officer of PAMET
registration in the place where he works ▪ Being the only authorized professional organization
First
Any person presenting or attempting to use as his own, the (APO) of all registered medical technologists in the
5 Member
certificate of registration of another Philippines.
Any person who shall give any false or fraudulent evidence of any ▪ Term of Office: Two (2) years
6 kind to the Board or any member thereof in obtaining a certificate President or officer of PASMETH
of registration as Medical Technologist ▪ Being the national organization of all deans or
Second
Any person who shall impersonate any registrant of like or the department chairpersons of schools, colleges, or
7 Member
same name universities offering medical technology course.
Any person who shall attempt to use a revoked or suspended ▪ Term of Office: Two (2) years
8
certificate of registration Credit Units
Any person who shall in connection with his name or otherwise, Coverage of the Area (includes the
Major Area % Required
ff but no limited to)
assume, use or advertise any title or description tending to convey RMT MLT
9
the impression that he is a Medical Technologist without holding a Profession’s Code of Ethics and Its
valid certificate of registration Ethics Applications, Regional/International 18 8 5
Any person or corporate body who shall allow anyone in his employ Ethics
All related laws, rules and
who is not a registered medical technologist/medical laboratory
regulations, Administrative Orders of
technician to engage in the practice of medical technology or the Department of Health (DOH) and
10 Standards of
recommend for appointment anyone to the position of medical related agencies, Resolutions of the
technologist/medical laboratory technician knowing that he is not Professional 27 12 8
Professional Regulation Commission
Practice
registered as such. (PRC) and the Professional
Any person or corporate body who shall violate the rules and Regulatory Board of Medical
regulations of the Board or orders promulgated by it after having Technology (PRBoMT)
All related laws, rules and
11 been duly approved and issued by the President of the Philippines
regulations, Administrative Orders of
upon recommendation of the Commissioner of Civil Service28 for Enhancement of
the Department of Health (DOH) and
the purpose of carrying out the provisions of this Act. Professional
related agencies, Resolutions of the
Practice and 44 20 14
Professional Regulation Commission
Technical
SECTION 30 SEPERABILITY CLAUSE – each and every section is (PRC) and the Professional
Competence
treated as a separate law Regulatory Board of Medical
Technology (PRBoMT)
SECTION 31 REPEALING CLAUSE
Environmental Gender and Development,
SECTION 32 EFFECTIVITY – this act shall take effect upon its Factors Personality Development,
approval (June 21, 1969) 11 5 3
Affecting the Environment Concerns, Social
Profession Responsibility
TOTAL 100 45 30

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 MTAP 1 || MEDICAL TECHNOLOGY LAWS AND BIOETHICS || RMT 2022
CL for Molecular Patho. only
REPUBLIC ACT NO. 4688
a. genetics, immune/ hematopathology and
CLINICAL LABORATORY LAW
infectious dse.
AN ACT REGULATING THE OPERATION AND THE MAINTENANCE OF
CLINICAL LABORATORIES AND REQUIRING THE REGISTRATION OF THE
BY FUNCTION
SAME WITH THE DEPARTMENT OF HEALTH, PROVIDING PENALTY FOR
Clinical Clinical laboratory concerned Clinical chem, IMH, BB,
VIOLATION THEREOF, AND FOR OTHER PURPOSES
Pathology with the diagnosis and Micro, Immunosero,
Title Referred to as the “CLINICAL LABORATORY LAW” treatment of diseases Hema, Para, CM, Toxi,
▪ 8 sections performed through lab testing TDM, Endocrinology
▪ Approved during the incumbency of Pres. of blood and other fluids
Ferdinand Marcos
Anatomic Clinical laboratory concerned Immunopatho, Cytology,
Approved date JUNE 18, 1966
Pathology with the diagnosis o disease Surgical patho, autopsy,
through microscopic forensic patho
SECTION 1 examination f tissues and
▪ Any person firm of corporation, maintaining or operating a clinical organs
laboratory, shall register and secure license annually at the office of
the Secretary of Health. INSTITUTIONAL CHARACTER
▪ Provided, that government hospital laboratories doing routine or Institutional Operates within the premises or part of an institution such
minimum laboratory examinations shall be exempt from provisions of
Based as hospital, school, medical clinic, medical facility, for
this section overseas workers and seafarers, birthing home, psychiatric
facility, drug rehabilitation center, and others.
SECTION 2 Hospital-based clinical laboratories are the most common
▪ It shall be unlawful for any person to be professionally in charge of a example of institution-based labs
registered clinical laboratory unless he is a licensed physician duly Free- Laboratory that is not part of an established institution
qualified in laboratory medicine and authorized by the Secretary of Standing The most common example is a free-standing outpatient
Health, such authorization to be renewed annually. clinical laboratory
▪ No license shall be granted or renewed by the Secretary of Health for
the operation and maintenance of a clinical laboratory unless such
SERVICE CAPABILITY
laboratory is under the administration, direction and supervision of an
Clinical laboratories under this category are licensed to perform
authorized physician, as provided for on the preceding paragraph
basic, routine laboratory testing
PRIMARY

Free Standing Institutional

SECTION 3 Routine urinalysis, stool exam, All others+ gram stain
▪ The Secretary of Health, through the Bureau of Research and hema, cbc (hgb, hct, wbc/rbc
Laboratory, shall be charged with the responsibility of strictly ct., wbc diff., qualitative plt ct.)
enforcing the provisions of this Act and shall be authorized to issue Clinical laboratories licensed to perform tests being done by the
such rules and regulations as may be necessary to carry out its primary category clinical laboratories along with routine clinical
provision.
SECONDARY

chemistry testing
Free Standing Institutional
SECTION 4 CC, Blood glucose conc., BUN, All others mentioned + gram
▪ Any person, firm or corporation who violates any provisions of this Act BUA, Blood creatinine, stain KOH mount, and
or the rules and regulations issued thereunder by the Secretary of Cholesterol determination, crossmatching
Health shall be punished with imprisonment for not less than one Qualitative plt ct.
month but not more than one year, or by a fine of not less than one Clinical laboratories licensed to perform test being done by the
thousand pesos nor more than five thousand pesos, or both such fine secondary clinical lab along with other test listed below
and imprisonment, at the discretion of the court IMMUNO-SERO TEST MICROBIO
NS1-Ag for dengue, Rapid Differential staining techniques,
ADMINISTRATIVE ORDER NO. 2021-0037 plasma reagin, Treponema culture, and identification of
New Rules and Regulations Governing the Regulation of Clinical pallidum particle agglutination bacteria of fungi from
TERTIRY

Laboratories in the Philippines test specimens, antimicrobial

Approved date JUNE 11, 2021 susceptibility testing
Objective ▪ Ensures accurate, precise and reliable Lab results; SPECIAL CC TEST SPECIAL HEMA TEST
and Clinical enzymology, TDM, BM studies, special staining for
▪ Lab. Results be released in a timely manner Markers for certain dse ab cells, red cell morphology
Scope and ▪ Applies to all entities performing the activities and IMMUNOHEMATOLOGY & BLOOD BANKING
Coverage functions of clinical labs Antibody screening, and identification, preparation of blood
▪ Excludes government hospital laboratories doing components, including the blood donation program
routine or minimum laboratory examinations

CLASSIFICATION
OWNERSHIP Government SPECIAL LABORATORIES
Private NATIONAL REFERENCE LABORATORY (NRL)
FUNCTION Clinical Pathology The “highest level of laboratory” in the country National Reference
Anatomic Pathology Laboratory; gov’t hospital lab designated by DOH and may or may not be a
Molecular Pathology** part of general clinical lab tasked for the ff: (CREST)
INSTITUTIONAL Institution-based ▪ Confirmatory testing
CHARACTER Freestanding ▪ Resolution of conflicting results
SERVICE CL Clinical & Anatomic Path. ▪ Evaluation of diagnostic kits and reagents
CAPABILTY a. Primary ▪ Surveillance and facilitation of Nat’l External Quality Assessment
b. Secondary Scheme (NEQAS)
c. Tertiary ▪ Training and research.
d. Limited Service Capability

CL for Anatomic Patho. only

a. Cytology & Histopathology

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 MTAP 1 || MEDICAL TECHNOLOGY LAWS AND BIOETHICS || RMT 2022
NRL TESTS LICENSE TO OPERATE
Philippine National ▪ Anatomic Pathology for Cardiovascular ▪ Issued in the name of the applicant/licensee
Heart Center (PNHC) Diseases ▪ Issued after compliance with the minimum requirement
National Kidney and ▪ Hematology ▪ Valid for 1 year
Transplant Institute ▪ Coagulation Tests ▪ NON-transferrable
(NKTI) ▪ Immunohematology ▪ Additional services (add-on services) must be reflected to the LTO,
▪ Immunopathology (i.e., MCL, SLC, confirmatory testing for G6PD Def., rHIVda, etc.)
▪ Anatomic Pathology for Renal Diseases ▪ Shall be under CL
▪ Automated Urinalysis  Arterial Blood Gas
Lung Center of the ▪ Clinical Chemistry  Radioimmunoassay for thyroid function test
Philippines (LCP) ▪ Anatomic Pathology for Pulmonary Diseases  Prostate Specific Antigen
STD/Aids Cooperative ▪ • HIV Screening & Confirmatory ▪ HFSRB/CHD – shall be informed for any substantial changes in the LTO
Central Laboratory ▪ Syphilis Screening and Confirmatory
(SACCL) / San Lazaro ▪ Hepatitis B and C Screening and Confirmatory
CERTIFICATE OF REGISTRATION
Hospital (SLH)
▪ Issued in the name of the applicant/licensee
Research institute for ▪ Dengue, Influenza, Tuberculosis and other
▪ Issued after compliance with the minimum requirement ü Valid for 1
Tropical Medicine Mycobacteria
year
(RITM) ▪ Malaria and other parasites
▪ NON-transferrable
▪ Bacterial Enteric Diseases
▪ Additional services (add-on services) must be reflected to the LTO,
▪ Measles and other Exanthems
(i.e., MCL, SLC, confirmatory testing for G6PD Def., rHIVda, etc.)
▪ Enterovirus
▪ Shall be under CL
▪ Antimicrobial Resistance
 Arterial Blood Gas
▪ Emerging and re-emerging Infections
 Radioimmunoassay for thyroid function test
▪ Confirmatory testing for Blood Donors and
 Prostate Specific Antigen
Blood Units
▪ HFSRB/CHD – shall be informed for any substantial changes in the LTO
▪ Rabies
▪ Japanese encephalitis and other pathogens
causing meningitis and meningoencephalitis REMOTE COLLECTION PERMIT FOR CLINICAL LABORATORY (RCP-CL)
East Avenue Medical ▪ Drug Test screening and confirmatory ▪ Issued only to CL that do not have MCL
Center (EAMC) ▪ Water Testing potability ▪ Valid only on the day of the activity
▪ Analytical Toxicology, Methemoglobin, ▪ Shall be secured w/in 7 days from intended remote collection
Hemoglobin and Sulfhemoglobin ▪ The activity shall last from 4 to 6 hours
▪ The remote collection facility shall be w/in 100km from CL
▪ Only RMTs are allowed to collect blood samples/specimens
MOBILE CLINICAL LABORATORY (MCL)
Specimens for Must be stored at refrigerator temp
Moves from testing site but affiliated with main laboratory.
Urinalysis/Fecalysis within 1 hour from time of collection
▪ Mobile labs permitted to operate within 100 kms radius from
Must be separated within 4 hours from
main lab; and Serum for Blood Chemistry
time of collection
Shall be allowed to perform the following on-site tests:
▪ Urinalysis STAFFING
▪ Fecalysis General Rule: ALL CL shall be headed by a Pathologist
▪ Pregnancy Test (lateral flow) certified in Clinical Pathology.
▪ Basis Serologic Test using Rapid Test Kits (Dengue, Screening for PATHOLOGIST
Hep. B, RPR/Syphilis Test and HIV) Exception: For Tertiary CL with anatomic pathology, it
▪ Note: Serum must be separated w/in 4 hours shall be headed by a Pathologist certified in both
Clinical and Anatomic Pathology.
At present, the number of laboratory professionals
PHYSICIAN’S LABORATORY (POL)
depend on the workload and working hours.
Refers to a doctor’s office/clinic wherein CL examinations are performed
▪ The working hours vary from a minimum of eight
for the purpose of monitoring the doctor’s patients only
(8) hours to a maximum of twelve (12) hours.
▪ wherein NO official results shall be issued.
▪ In this Order, POL within the premises of a DOH-regulated
In so determining the number of laboratory
facility shall be under the supervision of the CL.
professionals the following guidelines must be
Note: observed:
1. Monitoring examinations only MEDTECH/S
2. No official result is issued; and
3. Cater such doctor’s patients only

SATELIITE CLINICAL LABORATORY

Features of SCL:
▪ Extension of the main lab
▪ Located within the facility’s compound/premises
▪ With the same service capability as the main lab.
Reporting
▪ Bear the name, PRC registration number and
POINT OF CARE TESTING LABORATORY signature of Pathologist and RMT
Refers to diagnostic testing done at or near the site of patient care rather ▪ No report orally or in writing without directive
than in the CL. from pathologist or associate except in emergency
▪ It may be in the emergency room, operating suites, wards, and cases
ambulances. INFORMATION
▪ Note: CL that are operated and maintained
▪ Example: Random blood glucose, oxygen saturation, CT/BT, etc. MANAGEMENT
exclusively for research and teaching purposes
shall not issue official results for diagnostic
purposes

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 MTAP 1 || MEDICAL TECHNOLOGY LAWS AND BIOETHICS || RMT 2022
Recording
▪ All requests and reports of all specimens REPUBLIC ACT NO. 7719
submitted and examined NATIONAL BLOOD SERVICE ACT OF 1994
▪ Confidential AN ACT PROMOTING VOLUNTARY BLOOD DONATION, PROVIDING FOR AN
▪ Kept in file for at least 1 year ADEQUATE SUPPLY OF SAFE BLOOD, REGULATING BLOOD BANKS, AND
▪ Anatomic and forensic pathology reports are kept PROVIDING PENALTIES FOR VIOLATION THEREOF
permanently Title “National Blood Services Act of 1994”.
▪ This Act shall supersede Republic Act No.
STAFFING PATTERN FOR RMT ANALYSTS 1517 entitled “Blood Bank Act.
Approved date MAY 5, 1994

MANDATES OF R.A. 7719

 To promote and encourage voluntary blood donation.
 Blood donation is:
✓ A humanitarian act
✓ A non-profit blood collection.
✓ A professional medical service.
✓ Not a sale of a commodity.
 To curb the hazards caused by the commercial sale of blood.

AXIOMS PROVIDED UNDER R.A. 7719

1 Blood shall be collected from healthy voluntary donors only
2 All commercial blood banks shall be phased-out
3 All BSFs shall operate on a non-profit basis
.

4 All BSFs shall be registered and issued a licensed to operate

All blood bank/centers shall be under management of a licensed and
MONITORING AND INVESTIGATION OF CHARGES OR 5
qualified physician (pathologist/hematologist)
COMPLAINTS
HFSRB/CHD shall investigate the complaint
Director or shall suspend, cancel or revoke and may seek any law ADMINISTRATIVE ORDER 2008-0008
Rep enforcement agency to execute the closure of any erring Tulles and Regulations Governing the Regulation of
Title
lab when necessary. Blood Service Facilities
CL with revoked license can only re-apply after 1 year from the date of LTO DOA MAY, 02, 2008
revocation Description This AO shall apply to all government and private BSF

PROHIBITED ACTS
Refusal to allow HFSRB/CHD to conduct inspection and monitoring CLASSIFICATION OF BSF
1 1 Ownership (Government/Private)
visits
2 Refusal or non-participation in an EQAP 2 Institutional Character (Hospital/Non-Hospital based)
3 Absence of any action to improve unsatisfactory or failed EQAPD Service Capability
Demonstrating incompetence or making consistent error in the a. Blood Station (BS) – Storage, issuance, transport &
4 distribution of blood
performance of lab. proc./test
Deviation from standard test procedure including use of expired b. Blood Collection Unit (BCU) – Collection of blood
5 c. BS-BCU
reagents
6 Issuance of lab reports without the authority of the Head of the La d. Blood Bank (BB)
3
7 Transferring of lab results done by another lab e. Blood Centers
▪ Testing units of TTIs
8 Performing lab procedure beyond the authorized service capability
▪ All blood units screened by BCs shall not be retested
Giving and receiving kickbacks, commissions, bonus or engaging in
9 for TTIs by the end-user hospitals. – If found infected
split-arrangement
with any of the TTIs, the blood unit must be
10 Violation of the Data Privacy Act of 2012 (RA No 10173)
discarded within 48 hours.
PROHIBITED ACTS THAT RESULT TO IMMEDIATE REVOCATION
Other notes:
Permitting unauthorized or unregistered personnel to perform
1 General Rule.: Blood Units issued by the BCs shall not be re-tested for
technical process or access laboratory records/data
Transfusion – Transmitted Infections (TTIs)
Lending or using the name of the CL or head of the lab or med tech
2
to an unlicensed CL Exp: HIV Test, a patient may demand a second test, as a matter of right.
Unauthorized to use the name and signature of the pathologist and (Section 26(e) of R.A. No. 11166)
3
RMT to secure LTO
Issuance of fraudulent lab results or tests not actually done 5 CORE TESTS (WHO)
4
or inaccurate results 1. HIV 2
Change in ownership, location, and head of lab or personnel 2. Serum Hepatitis (HbsAg) 3
5
without informing the HFSRB/CHD 3. Antibody to Hepatitis C
6 Any material statement in the application of LTO 4. Test for Syphilis
5. Malaria
APPEAL
Head of Health Regulation Team (HRT) w/in 10 days after receipt of General Rule: LTO/ATO is valid for 3 years.
1 notice of decision. • The decision of HRT may be further appealed to
the Sec. of Health w/in 10 days from receipt of notice of decision. Exp: if the LTO/ATO issued to BB/BCUBS is part of hospital license, the
2 Decision of Health Sec. is final and executory LTO/ATO is valid for 1 year.

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RECORDS All records in BB are kept permanently
HFSRB and CHD (thru its director or his authorized
representative)
▪ Authorized to investigate complaints against
BSF or any of its personnel who violated R.A.
INVESTIGATION No. 7719 and its implementing rules and
regulations.
▪ It can impose the penalty of reprimand,
suspension or revocation of ATO/LTO be done
each test.
For those complaint decided by the CHD, an aggrieved
party may file an appeal to the Secretary of Health of
APPEAL the DOH within 30 days from receipt of the decision. •
The decision of the Secretary of Health shall be final
and executory
REPUBLIC ACT NO. 11166
PHILLIPINE HIV AND AIDS POLICY ACT
“AN ACT STRENGTHENING THE PHILIPPINE COMPREHENSIVE POLICY ON
HUMAN IMMUNODEFICIENCY VIRUS (HIV) AND ACQUIRED IMMUNE
DEFICIENCY SYNDROME (AIDS) PREVENTION, TREATMENT, CARE, AND
SUPPORT, AND, RECONSTITUTING THE PHILIPPINE NATIONAL AIDS
COUNCIL (PNAC), REPEALING FOR THE PURPOSE REPUBLIC ACT NO. 8504,
OTHERWISE KNOWN AS THE "PHILIPPINE AIDS PREVENTION AND
CONTROL ACT OF 1998", AND APPROPRIATING FUNDS THEREFORE”
Title PHILIPPINED HIV AND AIDS POLICY ACT
Approved date DECEMBER 20, 2018
R.A. No. 11166 is the law that:
Strengthens the Philippine Comprehensive Policy on Human
1 Immunodeficiency Virus (HIV) and Acquired Immune Deficiency
Syndrome (AIDS) Prevention, Treatment, Care, and Support;
Strengthens the Philippine Comprehensive Policy on Human
2 Immunodeficiency Virus (HIV) and Acquired Immune Deficiency
Syndrome (AIDS) Prevention, Treatment, Care, and Support;
3 Repeals Republic Act No. 8504;
R.A. No. 11166 is also known as the "Philippine HIV and AIDS Policy
4 SCREENING
Act," which was approved on December 20, 2018.
HUMAN IMMUNODEFICIENCY VIRUS HIV
HIV Refers to the virus, of the type called retrovirus, which
infects cells of the human immune system, and
destroys or impairs the cells' function.
HIV TESTING A procedure that is conducted to determine the
presence or absence of HIV in a person's body. HIV
testing:
✓ Confidential
✓ Voluntary
✓ Involves counseling
✓ Informed consent
Other notes:
Informed Consent – refers to the voluntary agreement of a person to
undergo or be subjected to a procedure based on full information,
whether such permission is written or conveyed verbally.
▪ Evolving Capacities of the Child – As a general rule, any person
who is at least 15 years of age shall have the authority to give
consent to take HIV testing.
▪ Those persons below 15 years of age or mentally incapacitated,
consent may be obtained from child’s parents and legal guardian.
▪ Mature Minor Doctrine – As an exception, even if the person is
below 15 years of age, the minor may still give consent to take
HIV testing provided that the minor is pregnant or engaged in
high- risk behavior, and duly assisted by a licensed social worker
or health worker.
Evolving Capacities of the Child – refers to the recognition of the
children’s capacity for self- determination as they grow up and to allow
their participation in opportunities for autonomous decision-making.
▪ Under the concept of Evolving Capacities of the Child, a child
refers to a minor who is at least 15 years of age but less than 18
years of age.
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Mature Minor Doctrine
▪ a.k.a. Gillick Principle or Gillick Competence
▪ Refers to the legal principle that recognizes the capacity of some
minors to consent independently to medical procedures, if they
have been assessed by qualified health professionals to
understand the nature of procedures and their consequences to
make a decision on their own.
▪ Under the Mature Minor Doctrine, a minor refers to:
1. Child who is less than 15 years of age; and
2. Who is pregnant or engaged to high-risk behaviour, and
3. Duly assisted by a licensed social worker or health worker
at the time of testing
CLASSIFICATION OF HIV TESTING
As to the Requirement of Consent:
VOLUNTARY Willingly submits to such test
Lack of consent, use of force or intimidation, the use of
testing as a prerequisite for employment or other
COMPULSARY
purposes, and other circumstances when informed
choice is absent.
Instances of Compulsory HIV Testing:
(a) When it is necessary to test a person who is charges with any of the
offenses punishable under Articles 264 and 266 on serious and
slight physical injuries, and Article 335 and 338 on rape and simple
seduction, both of Act No. 3815 or the "The Revised Penal Code", as
amended, and as also amended by Republic Act. No. 8553,
otherwise known as "The Anti-Rape Law of 1997"
(b) When it is necessary to resolve relevant issues under Executive
Order No. 209, otherwise known as "The Family Code of the
Philippines"; and
(c) As a prerequisite in the donation of blood in compliance with the
provisions of Republic Act No. 7170, otherwise known as the "Organ
Donation Act of 1991", and Republic Act No. 7719, otherwise known
as the "National Blood Services Act of 1994".
CLASSIFICATION OF HIV TESTING
As to the Phases
Initial serologic test performed to determine the
presence of antibody against HIV 1 and HIV
This test includes but is not limited to:
TEST ▪ Enzyme Immunoassay (EIA)
▪ Particle Agglutination Test (PA)
▪ Rapid Immunoassays
▪ Other screening tests for HIV antibody
Test performed on samples reactive to the screening
test to ensure that results are true positive. This test
includes but is not limited to:
CONFIRMATORY
▪ Western Blot (WB)
TEST
▪ Line Immunoassay (LIA) •
Immunofluorescence Assay (IF)
▪ Polymerase Chain Reaction (PCR)
ISSUANCE OF TEST RESULTS
The result of any test related to HIV shall be disclosed only to the
individual who submitted to the test
If the patient is below fifteen (15) years old, an orphan, or is
mentally incapacitated:
1 ▪ The result may de disclose to either of the patient's parents,
legal guardian, or a duly assigned licensed social worker or
health worker, whichever is applicable.
If the patient is below fifteen (15) years of age and not suffering
from any mental incapacity, has given voluntary and informed
2 consent to the procedure in accordance with “Mature Minor
Doctrine”
▪ The result of the test shall be disclosed to child.
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Standard Precaution on the Donation of Blood, Tissue, or Organ DRUG TESTING LABORATORY (DTL)
1 All donated blood shall also be subjected to HIV testing Refers to a private or government facility that is
Donation of tissue or organ, whether gratuitous or onerous, DESCRIPTION capable of testing a specimen to determine the
2 ▪ Shall be accepted by a laboratory or institution only after a presence of dangerous drugs therein.
sample from the donor has been tested negative for HIV 1. Ownership
All donors whose blood, organ or tissue has been tested positive ▪ Government
shall be: ▪ Private
▪ Deferred from donation
3 2. Institutional Character
▪ Notified of their HIV status
▪ Counselled ▪ Institution-based
▪ Referred for care and clinical management as soon as possible ▪ Freestanding
Donations of blood, tissue, or organ testing positive for HIV may be
4 accepted for research purposes only, and shall be subject to strict CLASSIFICATION 3. Service Capability
sanitary disposal requirements; ▪ Screening Laboratory – a laboratory
Second testing – may be demanded as a matter of right by the capable of performing screening
5 blood, tissue, or organ recipient or his/her immediate relatives tests.
before transfusion or transplant, except during emergency cases. ▪ Confirmatory Laboratory – a
laboratory capable of performing
HIV TRANSMISSION qualitative and quantitative
examinations of dangerous drugs
HIV Transmission – refers to the transfer of HIV from one infected person
from the specimen.
to an uninfected individual, through:
▪ Unprotected sexual intercourse
▪ Blood transfusion
▪ Sharing of contaminated intravenous needles
▪ Which may occur during pregnancy, delivery, and breastfeeding

MEDICAL CONFIDENTIALITY
Medical Confidentiality – refers to the core duty of medical practice
where the information provided by the patient to health practitioner and
his/her health status is kept private and is not divulged to third parties.

Exception to the Confidential Rule:

When complying with reportorial requirements of the national
1
active passive surveillance system of the DOH;
When informing other health workers directly involved in the
2
treatment or care of a PLHIV; and
When responding to a subpoena duces tecum and subpoena ad
3 testificandum issued by a court with jurisdiction over a legal
proceeding where the main issue is the HIV status of an individual.

TH PHILIPPINE NATIONAL AIDS COUNCIL

PNAC – An attached agency to the DOH that is primarily tasked to ensure
the implementation of the country's response to the HIV and AIDS
situation.
▪ It was created under E.O. No. 39
▪ Dated December 03, 1992

REPUBLIC ACT. NO. 9165

COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002
AN ACT INSTITUTING THE COMPREHENSIVE DANGEROUS DRUGS ACT OF
2002, REPEALING REPUBLIC ACT NO. 6425, OTHERWISE KNOWN AS THE
DANGEROUS DRUGS ACT OF 1972, AS AMENDED, PROVIDING FUNDS
THEREFOR, AND FOR OTHER PURPOSES
Title "Comprehensive Dangerous Drugs Act of 2002"
Approved date January 23, 2002
About the Law The whole law contains 102 sections
This law mandates the Department of Health (DOH) to
license, accredit, establish and maintain drug test
network and laboratory, initiate, conduct and support
scientific research on drugs and drug control
July 11, 2003 In carrying this mandate, the DOH promulgated the
“Implementing Rules and Regulations Governing the
Accreditation of Drug Testing Laboratories in the
Philippines”.
Other notes:
“Comprehensive Dangerous Drugs Act of 2002.”
▪ The law that repeals Republic Act No. 6425, otherwise known as
the “Dangerous Drugs Act of 1972.”
▪ It was approved on January 23, 2002.

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