practice profession

Composition of - Appointed by: the President of the Philippines

PRC - Term of office: 7 years (RA 8981)
- Chairperson: Teofilo S. Pilando Jr.
- Commissioners (2):
Medical Technology Laws and Bioethics o Atty. Erwin M. Enad
o Jose Y. Cueto Jr.
Nardito Moraleta Professionalizedthe MT course (Professional PAMET - National organization of all MT
Recognition) - Organized by Crisanto almario (9/15/63)
Worked for the approval of RA 5527 - 9/20/64 = 1st national convention (FEU)
Wrote the 1st MT code of ethics on 8/6/68 - Charlemagne Tamondong = 1st president
- - Nardito Moraleta = 2nd president
Norma Chang Revised the MT code of ethics on 3/7/97 - Current president: Luela Vertucio

Charlemagne Emergence of the Profession PASMETH - The Philippine Association of Schools of Medical
Tamondong PAMET president but not BSMT graduate Technology and Public Health, Inc.
- The national organization of all registered schools of
Hector Gentapan Wrote the PAMET hymn medical technology in the Philippines
Gayares Jr. - Formed in 1970
- 6/22/70 = 1st organizational meeting (UST)
Francis Jerota Created the melody & music of the PAMET hymn - 5/7/71 = 1st annual meeting (UST)
Pefanco - Dr. Gustavo Reyes = 1st president
- Current president: Dr. Bernard U. Ebuen
Wilma Hilgert- 1st MT curriculum to be used for BSMT
Hedrick Founder of MT education in the Philippines

Dr. Pio de Roda Started training of lab workers in the Philippines at Public
Dr. Sta. Ana Health lab

AUP (Adventist Old: PUC (Philippine Union College)

University of the 1st school to offer MT course in the Philippines
Philippines Approved by DepEd – 1953

Dr. Jesse Umali 1st graduate of PUC

OB-Gyne, owner of Omega Lab

Quiricada st., First Clinical Laboratory in the Philippines

Sta. Cruz, Manila Now known as the Manila Public Health Laboratory

First Clinical - Who?

Laboratory in the o 26th Medical Laboratory of the 6th
Philippines US army introduced the practice
- When?
o It was at the end of World War 2 that
the practice was introduced
- Where?
o Quiricada St., Sta. Cruz Manila
Other schools - 1957: University of Sto. Tomas
which adopted - 1960: Centro Escolar University
Medical - 1962: Far Eastern University
Technology
Course
THE PHILIPPINE MEDICAL TECHNOLOGY ACT OF 1969
• Republic Act No. 5527
• Act requiring the registration of medical technologists
in the Philippines, defining their practice, and for other
purpose relative to the performance of professional
service.
• A charter that formally creates medical technology as a
profession in the Philippines
• Approved on June 21, 1969

Section 1. Title. - This Act may be also cited as “the Philippine

Medical Technology Act of 1969”. Section 2. Definition of Terms.

• Amended by P.D. No. 498
o Subsections (a) and (d) of Section 2 of Republic Act No. 5527
• Practice of Medical Technology
A person is in the practice of medical technology
withing the meaning of this Act, if the following are
present:
a. Individual carries out tasks related to medical
technology for fee, salary, or other
compensation or reward paid or given directly
or indirectly through another.
b. Renders any professional services. (referred to in
enumerations 1-8 of section 2, paragraph “a”)
c. Performs 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.
• Pathologist
o Clinical Pathologist
▪ Diagnose and monitor disease based
on laboratory examination of bodily
fluid.
o Anatomic Pathologist
▪ Diagnose disease through examining
specimens derived from surgical
procedures,
• Medical Technologist
• Medical Laboratory Technician
• Accredited Medical Technology Training Laboratory
✓ Tertiary clinical laboratory
✓ Accredited with the HSFRB of the DOH
✓ Accredited with CHED
• Recognized School of Medical Technology
• Council
• Board

Section 3. Council of Medical Technology Education, Its Composition.

• This provision was initially amended by P.D. No. 498 and amended again by P.D. No. 1534.
• Council of Medical Technology Education (CMTE)
o Empowered to recommend the minimum required curriculum for the MT program, including the setting of
 policies, standards, and guidelines, as well as monitoring compliance, and evaluating the performance of
higher education institutions (HEIs) offering the course BSMT/BSMLS.
• Composition:
o Chairman: Chairperson of CHED
o Vice-Chairman: Chairperson of PRC
o Members:
▪ Director of the HSFRB (formerly known as BRL) of the DOH
▪ Chairman and two (2) members of the Medical Technology Board
▪ Representative of the Deans of Schools of Medical Technology and Public Health
▪ President of the Philippine Society of Pathologists and the Philippine Association of
Medical Technologies
• R.A. No. 7722 – “Higher Education Act of 1994”
o Creation of CHED Technical Panel of MT Education
o The power to recommend minimum required curriculum for the course of MT including the setting
of policies, standards, and guidelines for the MT program, and the monitoring of
compliance and evaluation of performance was effectively assumed by the Technical Panel and Technical
committee for Medical Technology education to CMTE

Council of MT Education Technical Panel of MT Education

Created by R.A. No. 5527 (Section 3) on June 21, Created by R.A. No. 7722 (Section 12) on May 18, 1994
Manner of Creation
1969 *Created by general law
*Created by specific law
Composition is expressly provided by the law
Composition Appointed by CHED
Term of Office Ex-officio capacity Ad hoc appointment
Expressly provided under Section 5 of Expressly provided under Sectoin 12 of R.A.
Function R.A. No, 5527 No. 7722 and their respective appointment papers

Section 4. Compensation and Travelling Expenses of Council Members.

• Amended by P.D. No. 498
• For every meeting actually attended:
o Chairman – fifty pesos (P50.00)
o Members –twenty-five pesos (P25.00)
• Chairman and members of the Council shall be entitled to traveling expenses in connection with their official
duties.

Section 5. Functions of the Medical Technology Education. - The functions of the Council shall be:
a) To recommend the minimum required curriculum for the course of medical technology.
b) To determine and prescribe the number of students to be allowed to take up the medical technology course in
each school, taking into account the student-instructor ratio and the availability of facilities for instruction.
c) To approve medical technology schools meeting the requirements and recommend closure of those found to
be substandard.
d) To require all medical technology schools to submit an annual report, including the total number of
students and instructors, a list of facilities available for instruction, a list of their recent graduates and new
admissions, on or "before the month of June.
e) To inspect, when necessary, the different medical technology schools in the country in order to
determine whether a high standard of education is maintained in said institutions.
f) To certify for admission into an undergraduate internship student who have satisfactorily completed three years
of the medical technology course or its equivalent and to collect from said students the amount of five pesos
each which money accrue to the operating fund of the council.
 g) Formulate and recommend approval of refresher course for applicants who shall have failed the Board
Examination for the third time.
h) To promulgate and prescribe and enforce necessary rules and regulations for the proper
implementation of the foregoing functions.

Section 6. Minimum Required Course. - The medical technology course shall be at least four years, including a 12-month
satisfactory internship in accredited laboratories, and shall include the following subjects:

English Biochemistry
Spanish Gross Anatomy
Social Science Histology
General Zoology Physiology
Botany Clinical Parasitology
Mathematics General Pathology
College Physics Microbiology
General Chemistry Biostatistics
Qualitative Chemistry Clinical Laboratory
Quantitative Chemistry Methods including hematology, serology, blood banking,
clinical microscopy, applied microbiology, and parasitology,
histopathologic techniques, and
cyto-technology.

The Council is hereby authorized, subject to the approval of the Secretary of Education to change, remove from or add to
the subjects listed above as the needs and demands of progress in the science of medical technology may require.

CMO No. 13 series of 2017

• “Policies, Standards, and Guidelines (PSGs) for the Bachelor of Science in Medical Technology or Medical Laboratory
Science (BSMT or MLS) Program”
• Prevailing memorandum order the implements this Section (R.A. No. 5527 Section 6) and in accordance with the higher
education act of 1994
• Effective: Academic Year 2018-2019
• Components: Total of 173 units
o General Education Core Courses: 24 units
o General Education Elective Courses: 9 units
o General Education Mandated Courses: 3 units
o Physical Education Courses:8 units
o NSTP Courses: 6 units

Clinical Internship:
• Total Exposure/Contact Hours: 1664 hours
o Clinical Chemistry: 300 hrs.
o Clinical Microscopy and Parasitology: 200 hrs.
o Microbiology: 250 hrs.
o Hematology: 300 hrs.
o Blood Banking: 200 hrs.
o Core Courses: 25 units
o Professional Courses: 65 units
o Research Courses: 5 units
o Clinical Internship Courses: 28 units
o Histopathologic Technique & Cytology: 100 hrs.
o Immunology and Serology: 220 hrs.
o Laboratory Management: 40 hrs.
o Phlebotomy: 54 hrs.
Section 7. Medical Technology Board.
• Amended by P.D. No. 498
• Composition:
o Chairman: Pathologist
o Members: 2 Registered Medical Technologist
• Appointed by the President of the Republic of the Philippines upon recommendation of the PRC.
• MTB shall hold office for three (3) years after appointment or until their successors shall have been
appointed and duly qualified.
• In case of death, disability, or removal of a member of the Board, his successor shall serve only the balance of
his term.

Section 8. Qualification of Examiners.

• Amended by P.D. No. 498
• 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
5) 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.

• Commissioner of the Civil Service will act as Executive Board of the MTB

P.D. No. 223

• “Creating The Professional Regulation Commission and Prescribing Its Powers and Functions”
• Effectively transferred the supervision and administration of Professional Regulatory Boards (PRBs) from Civil
Service Commission (CSC) to Professional Regulatory Commission (PRC).
o PRC is now the executive board of the MTB instead of the commissioner of CSC
• Section 7. Names of various Boards. - The names of the various Boards shall be changed by the
Commission by deleting the word "Examiners."
o Thus, the name “Board of Examiners of Medical Technology” is now called the Medical
Technology Board (MTB)

Section 10. Compensation of Members of the Board of Examiners for Medical Technology.
• This section was impliedly repealed by Section 10 of R.A. No. 8981 ("PRC Modernization Act of 2000.")
• Section 10. Compensation of the Members of the Professional Regulatory Boards.
o 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: Provided, That the Chairperson of
the Regulatory Board shall receive a monthly compensation of two steps higher than the members of the
Board, and: Provided, further, that they shall be entitled to other allowances and benefits provided under
existing laws.
Section 11. Functions and Duties of the Board. – The Board is vested with authority and required, conformably with the
provisions of this Act, to:
a. Administer the provisions of this Act;
b. Administer oaths in connection with the administration of this Act;
c. Issue, suspend and revoke certificates of registration for the practice of medical technology and medical
laboratory technician;
 d. 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;
e. 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
f. 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;
g. To determine the adequacy of the technical staff of all clinical laboratories and blood banks before they could be
licensed with the Department of Health in accordance with R.A. No. 4655 and 1517;
h. To 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 Commission;
i. To 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.

Note:
• P.D. No. 498
o Amended subsection (c)
o Added subsections (g), (h), and (i)
• P.D. No. 1543 repealed subsections (g) and (i)

Section 12. Removal of Board Members. – 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.

Section 13. Accreditation of Schools of Medical Technology and of Training Laboratories

• Initially amended by P.D. No. 498 (Section 7) and amended again by P.D. No. 1534 (Section 4).
• Repealed by R.A. No.7722
o Section 3. Creation of the Commission on Higher Education. - In pursuance of the abovementioned
policies, the Commission on Higher Education is hereby created, hereinafter referred to as the
Commission.

The Commission shall be independent and separate from the Department of Education, Culture and Sports
(DECS), and attached to the Office of the President for administrative purposes only. Its coverage shall be
both public and private institutions of higher education as well as degree- granting programs in all post-
secondary educational institutions, public and private.
• Accreditation of schools of MT and of training laboratories is now under the CHED

Section 14. Inhibition Against the Practice of Medical Technology. – No person shall practice or offer to practice medical
technology as defined in this Act without having previously obtained a valid certificate of registration from the Board
provided that registration shall not be required of the following:
a. Duly registered physicians.
b. Medical technologist from other countries called in for consultation or as visiting or exchange professors to
colleges or universities: Provided, they are only practicing the said function.
c. Medical technologists in the service of the United States Armed Forces stationed in the Philippines rendering
services as such for members of the said forces only.
Section 15. Examination. – Except as otherwise specifically allowed 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.
• This provision was modified by R.A. No. 8981, otherwise known as the PRC Modernization Act of 2000.
• Given twice a year, every March and September
• Testing Areas:
o Manila, Baguio, CDO, Cebu, Davao, Iloilo, Tacloban, Tuguegarao, and Zamboanga
• Examination shall also be published in at least three newspapers of national circulation by the
Secretary of the Board at least thirty days prior to the date of examination

Section 16. Qualification for Examination. – Every applicant examination under this Act, shall, prior to the date thereof, furnish
the Board 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 date of the examinations, if such performance began
prior to June 21, 1969.
• P.D. No. 498 added Section 16 paragraph (b)

Section 17. Scope of Examination. – The examination questions shall cover the following subjects with their respective relative
weights:
Clinical Chemistry …………………………………………. 20%
Microbiology & Parasitology …………………………....... 20%
Hematology ………………………………………………… 20%
Blood Banking & Serology …………………………….…. 20%
Clinical Microscopy
(Urinalysis and other body fluids) …………………..…… 10%
Histopathologic Techniques, Cytotechnology,
Medical Technology Law, Related Laws and Its
Implementing Rules,
and the Code of Ethics …………………………………… 10%
The Board shall prepare the schedule of subjects for examination and to submit the same to the Commissioner of
the Professional Regulation Commission for publication at least thirty (30) days before the date of examination. The Board
shall compute the general average of each examinee according to the above- mentioned relative weights of each subject.
Provided, however, that the Board may change, add to or remove from the list of subjects or weights above as progress in
the science of Medical Technology may require, subject to the prior approval of the Professional Regulation Commission,
and publication of the change or amendment at least three (3) months prior to the date of examination in which the same
is to take effect
• This section was added by P.D. No. 498

Section 18. Report of Rating. – The Board shall, within one hundred and twenty 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 section is repealed by R.A. No. 8981 (“PRC Modernization Act of 2000”)
• Section 9, paragraph (h) of R.A. No. 8981
 o “…score and rate the examination papers with the name and signature of the Board member
concerned (MTB) appearing thereon and submit the results in all subjects duly signed by the members
of the Board to the Commission (PRC) within ten (10) days from the last day of examination unless
extended by the Commission for justifiable cause/s…”

Section 19. Rating in the Examination.

• Candidate must obtain a general average of at least seventy-five percent in the written test
o no rating below fifty percent in any of the major subjects
o not failed in at least sixty percent of the subjects computed according to their relative weights.
• No further examinations, unless and until he shall have completed 12 months refresher course in an
accredited laboratory.

Subjects Examinee A Examinee B Examinee C Examinee D

Clin. Chem. 74 89 71 80
Micro. / Para. 94 87 69 87
Hema. 74 49 74 51
B.B. / Sero 74 98 75 87
C.M. 96 85 80 81
Histopath. / MTLBE 96 85 70 85
82.4 81.6 72.8 77.6

Examinee A – FAILED
• He failed 60% of the subjects computed according to their relative weights
Examinee B – FAILED
• His Hematology rating is below
50% Examinee C – FAILED
• His general weighted average (GWA) is less than 75%
Examinee D – PASSED
• His GWA is above 75%. His failed rating in Hema. is negligible because it’s not below 50%

Section 20. Oath Taking. – All successful examinees shall be required to take a professional oath before the Board or before
any person authorized to administer oaths prior to entering upon the practice of medical technology in the Philippines.
***Propesyon – Medikal Teknolohist

Section 21. Issuance of Certificate of Registration.

• Every applicant who has satisfactorily passed the required examination for medical technologist shall be issued
a certificate of registration.
o no such certificate shall be issued to any successful applicant who has not attained the age of twenty-
one (21) years.
• All certificates shall be signed by
o Members of the Board
o Commissioner of the Professional Regulation Commission.
• RMTs are required to display their Certificate of Registration (COR) in their workplace.
• The Board shall likewise issue a COR as medical laboratory technician to those who 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 22. Fee. – 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 section was repealed by Section 7, paragraph (g) of R.A. No. 8981
o “To determine and fix the amount of fees to be charged and collected for examination,
registration, registration without examination, professional identification card, certification,
docket, appeal, replacement, accreditation, including surcharges and other fees not specified under the
provisions of R.A. No. 465 as amended by R.A. No. 6511 or to charge and collect reasonable fees at the
rates higher than the rates provided thereunder subject to the approval by the Office of the President.”

Section 23. Refusal to Issue Certificate

• The Board shall refuse to issue a certificate of registration to;
o any person convicted by the court of competent jurisdiction of any criminal offense involving moral
turpitude
o any person guilty of immoral or dishonorable conduct
o unsound mind
o incurable communicable disease
• A written statement setting forth the reason for the refusal to issue certificate is given to the individual.

Section 24. Administrative Investigation.

• Revocation or Suspension of Certificates
o Administrative investigation - conducted by at least 2 members of the Board with 1 legal officer sitting
during all administrative proceedings.
o 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.
o Penalties:
▪ Reprimand an erring medical technologist
▪ Revoke COR
▪ Suspend COR
o No penalty of revocation shall be imposed unless there is a unanimous vote of all the three
members of the Board.
o Suspension
▪ Does not exceed 2 years
▪ COR should be surrendered within 30 days after the decision becomes final.
▪ Shall run from the date when COR is surrendered.

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.
• Modified by Section 9(c) of R.A. No. 8981
o “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, become final and executory after fifteen (15) days
from receipt of notice of judgment or decision”
• Prevailing rules:
o The appeal shall be made to the PRC
o The appeal shall be made within 15 days from receipt of the decision
o The 15-day provision shall commence from :receipt” of a copy of the Notice of Judgement 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.

Section 27. Foreign Reciprocity. – No foreigner shall be admitted to examination or be given a certificate of registration or
be entitled to any of the rights and privileges under this Act, unless the country or state of which he is a subject or citizen
permits Filipino Medical Technologist to practice within its territorial limits on the same as the subject or citizens of said
country or state.
• Further reiterated under Section 7(j) of R.A. 8981
o the requirements for the registration or licensing in said foreign state or country are substantially the
same as those required and contemplated by the laws of the Philippines
o the laws of such foreign state or country allow the citizens of the Philippines to practice the
profession on the same basis and grant the same privileges as those enjoyed by the subjects or citizens of
such foreign state or country
o Commission may, upon recommendation of the Board concerned, authorize the issuance of a certificate
of registration/license or a special temporary permit to:
▪ foreign professionals who desire to practice their professions in the country under
reciprocity and other international agreements
▪ consultants in foreign-funded, joint venture or foreign-assisted projects of the
government
▪ employees of Philippine or foreign private firms or institutions pursuant to law
▪ health professionals engaged in humanitarian mission for a limited period of time
o Agencies, organizations or individuals whether public or private, who secure the services of a foreign
professional authorized by law to practice in the Philippines for reasons aforementioned, shall be
responsible for securing a special permit from the Professional Regulation Commission (PRC) and the
Department of Labor and Employment (DOLE), pursuant to PRC and DOLE rules

Section 28. Roster of Medical Technologist.

• Prepared annually by the Secretary of the Board
• This roster shall contain the name, address and citizenship of each registered Medical Technologist, date of
registration or issuance of certificate, and other data which in the opinion of the Board are pertinent.
• Open to public inspection and copies thereof shall be mailed to each person included therein, placed on file in the
Office of the President, furnished all Department Heads and all bureau, offices and instrumentalities of the
Department of Health and to such other offices, private or governmental, and to the public upon request.
Section 29. Penal Provisions. – Without prejudice to the provision of the Medical Act of 1959 as amended relating to illegal
practice of Medicine, the following shall be punished by a fine of not less than two thousand pesos nor more than five
thousand pesos, or imprisonment for not less than six months nor more than two years, or both, in the discretion of the
court:
a. Any person who shall practice Medical Technology in the Philippines without being registered or exempted
from registration in accordance with the provisions of this Act;
b. Any medical technologist, even if duly registered, who shall practice medical technology in the Philippines
without the necessary supervision of a qualified pathologist or physician authorized by the Department of
Health;
c. Any medical technologist who shall knowingly make a fraudulent laboratory report;
d. Any duly registered medical technologist who shall refuse or fail, after due warning by the Board to display
his certificate of registration in the place where he works;
e. Any person presenting or attempting to use as his own, the certificate of registration of another;
f. Any person who shall give any false or fraudulent evidence of any kind to the Board or any member thereof in
obtaining a certificate of registration as Medical Technologist;
g. Any person who shall impersonate any registrant of like or the same name;
h. Any person who shall attempt to use a revoked or suspended certificate of registration;
i. Any person who shall in connection with his name or otherwise, assume, use or advertise any title or description
tending to convey the impression that he is a Medical Technologist without holding a valid certificate of
registration;
j. Any person or corporate body who shall allow anyone in his employ who is not a registered medical
technologist/medical laboratory technician to engage in the practice of medical technology or recommend for
appointment anyone to the position of medical technologist/medical laboratory technician knowing that he is
not registered as such.
k. Any person or corporate body who shall violate the rules and regulations of the Board or orders promulgated by
it after having been duly approved and issued by the President of the Philippines upon recommendation of the
Commissioner of Civil Service for the purpose of carrying out the provisions of this Act.

Section 30. Separability Clause. – All acts, executive, rules and regulations, or parts thereof inconsistent with the provisions
to any persons or circumstances is declare invalid by a court of competent jurisdiction, the remainder of this Act of the
application of such provisions to other persons or circumstances shall not be
affected by such declaration.

Section 31. Repealing Clause. – All acts, executive, rules and regulations, or parts thereof inconsistent with the provisions of this
Act are hereby repealed: Provided, however, that nothing in this Act shall be construed as repealing or amending any portion of;
• The Medical Act of 1959 (R.A. 2382, as amended by R.A. 4224)
• The Clinical Laboratory Act of 1966 (R.A. 4688)
• The Blood Banking Law of 1956 (R.A. 1517).

Section 32. Effectivity. – This Act shall take effect upon its approval.
THE “CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016”
• Republic Act No. 10912
• An act mandating and strengthening the continuing professional development program for all regulated
professions, creating the continuing professional development council, and appropriating funds therefor, and for
other related purposes.
• Lapsed into law on July 21, 2016
o Under the constitution, a bill will become a law if not vetoed by the President within 30 days from
receipt, and it shall lapse into law as if he signed it.
• Effective: August 26, 2016
• Continuing Professional Development (CPD)
o refers to the inculcation of advanced knowledge, skills and ethical values in a post-licensure
specialization or in an inter- or multidisciplinary field of study, for assimilation into professional
practice, self-directed research and/or lifelong learning

• CPD Council
o A body created to promote and ensure the continuous improvement of professionals, in
accordance with national, regional, and international standards of practice.
o The CPD Council for Medical Technology operates under the supervision of the MTB, and is composed
of the following:
▪ Chairperson – Member of MTB chosen by the MTB
▪ Members
• President or officer of PAMET
• President or officer of PASMETH
o Term of office
▪ Chairperson – coterminous with his/her incumbency in the PRB
▪ Members – 2 years unless sooner replaced through a resolution

• Powers, Functions and Responsibilities of the CPD Council

o Ensure the adequate and appropriate provision of CPD Programs for their respective
profession;
o Evaluate and act on applications for accreditation of CPD Providers and their CPD Programs;
o Monitor and evaluate the implementation of the CPD Programs;
o Assess and/or upgrade the criteria for accreditation of CPD Providers and their CPD Programs on a
regular basis;
o Develop mechanisms for the validation, accreditation and recognition of self-directed learning,
prior/informal learning, online learning, and other learning processes through professional work
experience;
o Conduct researches, studies and benchmarking for international alignment of the CPD
Programs;
o Issue operational guidelines, with the approval of the PRC and the PRB concerned; and
o Perform such other functions related or incidental to the implementation of the CPD.

• CPD is made as a mandatory requirement in the renewal of the Professional Identification Cards of all registered
and licensed professionals under the regulation of the PRC.
Implementing Rules and Regulations of R.A. No. 10912

• PRC Resolution No. 1032 Series of 2017

o “IRR of R.A. No. 10912”

• PRC Resolution No. 2019-1146 Series of 2019

o Amending Relevant Provision of Resolution No. 1032 (s.2017) otherwise known as the “IRR of
R.A. No. 10912, known as the CPD Act of 2016”
o Amendments to PRC Resolution No. 1032 Series of 2017:
▪ Section 3.27
▪ Section 8.2.4
▪ Sections 10.1, 10.2, 10.3, 10.4
▪ Addition of Section 10.5
▪ Section 11
▪ Addition of Section 14 under Rule III
▪ Addition of Section 15, 15.1, 15.2, 15.3 under Rule III
▪ Renumbering of Sections 14 to 19 of Rule IV

• PRB of Medical Technology Resolution No. 7, series of 2018

o “Operational Guidelines on the Implementation of R.A. No. 10912, otherwise known as “CPD Act of
2016” for Medical Technologist”

o Section 1. Date/s of Regular Meeting/s. – The CPD Council under the supervision of Board, is hereby
mandated under this Resolution to meet every 4th Thursday of the month for the purpose of evaluating the
applications for accreditation as CPD provider, program, self-directed and/or lifelong learning and other
CPD related matters. The CPD council however, has the option to move the schedule a week before or
after for a justifiable reason and upon issuance of notice.

o Section 9. Major Areas of Activity

▪ Ethics
• Profession’s code of ethics and its application, regional/international ethics
▪ Standards of Professional Practice
• All related laws, rules, and regulations, AO of the DOH, Resolutions of PRC and PRB of
MT
▪ Enhancement of Professional Practice and Technical Competence
• Updates, capacity, and credential building
▪ Environmental Factors Affecting the Profession
• Gender and development, personality development, environment concerns, social
responsibility
o Section 10. Required CPD Credit Units in Compliance Period
▪ The required credit unit for renewal of PIC per compliance period of three (3) years shall be as
follows:
• Registered Medical Technologists (RMTs): 45
• Medical Laboratory Technicians (MLTs): 30
THE “CLINICAL LABORATORY LAW”
• Republic Act No. 4688
• 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 – June 18, 1966

SECTION 1. Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues,
secretions, excretions and radioactivity from beings or animals are analyzed for the determination of the presence of
pathologic organisms, processes and/or conditions in the persons or animals from which they were obtained, shall register
and secure a license annually at the office of the Secretary of Health: Provided, That government hospital laboratories
doing routine or minimum laboratory examinations shall be exempt from the provisions of this section if their services are
extensions of government regional or central laboratories.

SECTION. 2. It shall be unlawful for any person to be professionally in-charge of a registered clinical laboratory unless he is
a licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health, such authorization to
be renewed annually.

No license shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory
unless such laboratory is under the administration, direction and supervision of an authorized physician as provided for in
the preceding paragraph.

SECTION. 3. The Secretary of Health, through the Bureau of Research and Laboratories (BRL) shall be charged with the
responsibility of strictly enforcing the provisions of this Act and shall be authorized to issue such rules and regulations as
may be necessary to carry out its provisions.
• BRL is now known as Health Facilities and Services Regulatory Bureau (HFSRB)

SECTION. 4. Any person, firm or corporation who violates any provisions of this Act or the rules and regulations issued
thereunder by the Secretary of Health shall be punished with imprisonment for not less than one month but not more than
one year, or by a fine of not less than one thousand pesos nor more than five thousand pesos, or both such fine and
imprisonment, at the discretion of the court.

SECTION. 5. If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the
judgment shall not affect, impair, or invalidate the remainder thereof.

SECTION. 6. The sum of fifty thousand pesos, or so much thereof as may be necessary, is hereby authorized to be
appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effect the provisions of this
Act.

SECTION. 7. All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed. SECTION. 8. This

Act shall take effect upon its approval.

DOH MANDATES IN RELATION TO R.A. NO. 4688

Administrative Order No. 2012-0021 • National Framework of the National Health Laboratory Network
(NHLN)
• Approved on October 12, 2012
Department Memo. No. 2009-0086 • “Implementation of External Quality Assessment Program as a
Regulatory Requirement for Licensing of Clinical Laboratories”
• Approved on February 3, 2009

Department Order. No. 2009-5148 • Amended to D.O. No. 393 – E Series of 2000
• Philippine Heart Center as the NRL in anatomic
pathology of cardiac diseases
Administrative Order No. 2007-0027-A • Amendment to A.O. No. 2007-0027
• “Revised Rules and Regulations Governing the Licensure
and Regulation of Clinical Laboratories”
o Amendment to Section III of A.O. No. 2007- 0027 to
exempt National Tuberculosis Reference Laboratory
from securing a License to Operate
o Approved on August 28, 2008

Administrative Order No. 2007-0027 • “Revised Rules and Regulations Governing the Licensure
and Regulation of Clinical Laboratories”
• Current IRR of R.A. No. 4688
• Approved on August 22, 2007
Administrative Order No. 2007-0011 • Repeal of A.O. No. 118-B series of 1992, entitled “Rules and
Regulations Governing the Accreditation of Clinical Laboratories
for the Training of Medical Technology Interns”
• Approved on April 4, 2007

Administrative Order No. 59, series 2001 • “Rules and regulations governing the establishment, operation,
and maintenance of clinical laboratories in the Philippines”
• Approved on November 19, 2001

Department Order No. 393 – E series 2000 • “Designation of national reference laboratories and transfer of
corresponding equipment, instruments, supplies, specimens,
records form the bureau of research and laboratories to the
designated national reference laboratories”
• Designation of 5 NRL to undertake the functions of BRL
• Approved on November 14, 2000

Bureau Order No. 04, series of 1990 • “Technical Standards for the Registration, Operation, and
Maintenance of Clinical Laboratories in the
Philippines”
Classification of Clinical Laboratories
• Ownership
o Government clinical laboratories
o Private clinical laboratories
• Function
o Clinical Pathology
▪ Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology, Clinical
Microscopy, Histopathology, Cytology, Toxicology, Endocrinology, Molecular Biology,
Cytogenetics, Therapeutic Drug Monitoring, and other similar disciplines
o Anatomic Pathology
▪ Surgical Pathology, Immunohistopathology, Cytology, Autopsy, Forensic Pathology, and Molecular
Pathology
• Institutional Character
o Institution-based clinical laboratories
o Freestanding laboratories
• Service Capability
o General Clinical Laboratories
▪ Primary Category
• Routine hematology
• Qualitative platelet determination
• Routine urinalysis
• Routine fecalysis
• Blood typing (for hospital-based)
▪ Secondary Category
• Routine clinical chemistry
• Quantitative platelet determination
• Cross-matching (for hospital-based)
• Gram staining
• KOH (for hospital-based)
▪ Tertiary Category
• Special chemistry
• Special hematology, including coagulation procedures
• Immunology
• Microbiology – culture and sensitivity
o Aerobic and anaerobic (for hospital-based)
o Aerobic or anaerobic (for hospital-based)
▪ Limited-Service Capability
• Institution-based only
• Provide laboratory tests required for a particular service in institutions such as, but
not limited to, dialysis center and social hygiene clinics
▪ Department Memorandum No. 148 s.2003
• Minimum Technical Working Area
o Primary – at least 10m2
o Secondary – at least 20m2
o Tertiary - 60m2
 o Special Clinical Laboratories
▪ Assisted reproduction technology
▪ Molecular and cellular technology
▪ Molecular biology
▪ Molecular pathology
▪ Forensic pathology
▪ Anatomic pathology

Licensing
• License to Operate (LTO)
o Document issued by the DOH to an individual, agency, partnership, or a corporation that operates
a clinical laboratory upon compliance with the requirements set forth by the law.
o Only issued to clinical laboratories that comply with the standards and technical requirements
formulated by HFSRB
o Validity: one year, renewed annually
• Physician’s Office Laboratory (POL)
o Individual doctor’s office/clinic wherein lab examinations are performed.
o Permitted as long as they are used for monitoring patients
o License are required if the POL:
▪ Issue official lab results
▪ Perform more than monitoring examinations
▪ Provide services to individual other than the physician’s own patients
• Mobile Clinical Laboratory
o Specialized facility that moves from one testing site to another or has a temporary testing
location. It shall have a base laboratory.
o Permitted to collect specimens only.
o Operate within 100-kilometer radius from its main lab.
o Remote Collection Permit for Clinical Laboratory (RCP-CL)
▪ Required to conduct mobile collection. Secured form the DOH
▪ Must be secured at least 7 working days prior the scheduled remote activity
▪ Valid for 2 weeks

Supervision, Management, and Staffing

• Pathologist – Head
o No Pathologists in the area
▪ Physician with complete training in clinical laboratory medicine and laboratory
management
• Number of MT Required:
o Manual Testing
▪ 50 tests/RMT/8 hours
▪ 75 tests/RMT/12 hours
o Automated Testing
▪ 100 tests/RMT/8 hours
▪ 150 tests/RMT/12 hours
National Reference Laboratory (NRL)
• Laboratory in government hospital which has been designated by the DOH to provide special function and
services for specific disease areas.
• Enforced by D.O. No. 393-E series 2000 as amended by D.O. No. 2009-5148

• Functions:
o To provide laboratory referral services, e.g. for confirmatory testing, surveillance, research.
o To train laboratory personnel.
o To maintain a quality assurance program for laboratory tests – in coordination with the Bureau of Health
Facilities and Services, DOH
o To evaluate test kits and reagents – in coordination with the Bureau of Food and Drugs and the Bureau
of Health Devices and Technology, DOH.

• Designated NRLs
NATIONAL REFERENCE LABORATORIES
o Research Institute for Tropical Medicine 1. RESEARCH - Dengue, Influenza, TB & other mycobacteria,
INSTITUTE FOR malaria & other parasites, bacterial enteric
▪ National Reference Laboratory for Dengue, TROPICAL MEDICINE diseases, measles & other exanthems,
Influenza, Tuberculosis and other (RITM) mycology, enteroviruses, antimicrobial
resistance and emerging diseases
Mycobacteria, Malaria and other parasites, - Confirmatory testing of BLOOD DONORS and
Bacterial enteric diseases, measles and BLOOD UNITS.
other viral exanthems, Mycology, 2. EAST AVENUE Environment & Occupational Health,
MEDICAL CENTER Toxicology (DRUGS) and Micronutrient Assay
Enteroviruses, Antimicrobial resistance and (EAMC)
Emerging Diseases; NRL for confirmatory 3. NATIONAL KIDNEY HEMATOLOGY, Immunohematology and
AND TRANSPLANT Immunopathology
testing of blood donors and blood units. INSTITUTE (NKTI)
4. STD – AIDS CENTRAL HIV-AIDS, Hepatitis and STIs
o San Lazaro Hospital COOPERATIVE
▪ National Reference Laboratory for LABORATORY
(SACCL) – SAN
HIV/AIDS, Hepatitis and Sexually LAZARO HOSPITAL Transmitted
Diseases (STI/AIDS Cooperative Central
5. LUNG CENTER OF Anatomic Pathology and Biochemistry
Laboratory – SACCL) THE PHILIPPINES
(LCP)
o East Avenue Medical Center 6. PHILIPPINE HEART Anatomic Pathology for Cardiac Diseases
▪ National Reference Laboratory or CENTER (PHC)

Environmental and Occupational Health; Toxicology and Micronutrient Assay.

o National Kidney and Transplant Institute

▪ National Reference Laboratory for Hematology including immunohematology (consistent with
previously issued D.O. 301–I series 1999)
▪ National Reference Laboratory for Renal Disease and other unassigned Organ System Diseases,
and Automated Method for Urinalysis (Amended by D.O. No. 2009-5148)

o Lung Center of the Philippines

▪ National Reference Laboratory for Anatomic Pathology and Biochemistry (original
provision of D.O. No. 393-E series 2000)
▪ National Reference Laboratory for Anatomic Pathology for Pulmonary Diseases
(Amended by D.O. No. 2009-5148)

o Philippine Heart Center

▪ National Reference Laboratory in Anatomic Pathology for Pulmonary Diseases
(Amended by D.O. No. 2009-5148)
THE “NATIONAL BLOOD SERVICES ACT OF 1994”
• An act promoting voluntary blood donation, providing for an adequate supply of safe blood, regulating blood
banks, and providing penalties for violation thereof.
• Approved – May 05, 1994

Section 1. Title. — This Act shall be known as the "National Blood Services Act of 1994."

Section 2. Declaration of Policy. — In order to promote public health, it is hereby declared the policy of the State:
(a) to promote and encourage voluntary blood donation by the citizenry and to instill public consciousness of the
principle that blood donation is a humanitarian act;
(b) to lay down the legal principle that the provision of blood for transfusion is a professional medical service
and not a sale of a commodity;
(c) to provide for adequate, safe, affordable and equitable distribution of supply of blood and blood
products;
(d) to inform the public of the need for voluntary blood donation to curb the hazards caused by the
commercial sale of blood;
(e) to teach the benefits and rationale of voluntary blood donation in the existing health subjects of the formal
education system in all public and private schools, in the elementary, high school and college levels as well as
the non-formal education system;
(f) to mobilize all sectors of the community to participate in mechanisms for voluntary and non-profit
collection of blood;
(g) to mandate the Department of Health to establish and organize a National Blood Transfusion Service Network in
order to rationalize and improve the provision of adequate and safe supply of blood;
(h) to provide for adequate assistance to institutions promoting voluntary blood donation and providing non-
profit blood services, either through a system of reimbursement for costs from patients who can afford to pay,
or donations from governmental and non-governmental entities;
(i) to require all blood collection units and blood banks/ centers to operate on a non-profit basis;
(j) to establish scientific and professional standards for the operation of blood collection units and blood
banks/centers in the Philippines;
(k) to regulate and ensure the safety of all activities related to the collection, storage and banking of blood; and
(l) to require upgrading of blood banks/centers to include preventive services and education to control spread of
blood transfusion transmissible diseases.

Section 3. Definitions. — For purposes of this Act, the following terms shall mean:
A. Blood/blood product — refers to human blood, processed or unprocessed and includes blood
components, its products and derivatives;
B. Blood bank/center — a laboratory or institution with the capability to recruit and screen blood donors, collect,
process, store, transport and issue blood for transfusion and provide information and/or education on blood
transfusion transmissible diseases;
C. Commercial blood bank — a blood bank that exists for profit;
D. Hospital-based blood bank — a blood bank which is located within the premises of a hospital and which can
perform compatibility testing of blood;
E. Blood collection unit — an institution or facility duly authorized by the Department of Health to recruit and
screen donors and collect blood;
F. Voluntary blood donor — one who donates blood on one's own volition or initiative and without
monetary compensation;
G. Department — the Department of Health;
H. Blood transfusion transmissible diseases - diseases which may be transmitted as a result of blood
transfusion, including AIDS, Hepatitis-B, Malaria and Syphilis;
 I. Secretary of Health — the Secretary of Health or any other person to whom the Secretary delegates the
responsibility of carrying out the provisions of this Act; and
J. Walking Blood Donor — an individual included in the list of qualified voluntary blood donors referred to in Section
4, paragraph (e), who is ready to donate blood when needed in his/ her community.

Section 4. Promotion of Voluntary Blood Donation. — In order to ensure adequate supply of human blood, voluntary blood
donation shall be promoted through the following:
(a) Public Education. — Through an organized and sustained nationwide public education campaign by the
Department, the Philippine National Red Cross (PNRC) and the Philippine Blood Coordinating Council (PBCC), as
the lead agencies, other government agencies, local government units (particularly the barangays), non-
governmental organizations, all medical organizations, all public and private hospitals, all health and health-
related institutions, print and broadcast media as well as other sectors. The
Department is hereby authorized to set aside funds and generate financial support for all sectors involved in the
collection and processing of blood from voluntary blood donors through a system of reimbursement for costs for
patients who can afford to pay or from donations from government and private institutions. Voluntary donors shall
likewise be provided nonmonetary incentives as may be determined by the Department.
(b) Promotion in Schools. — The benefits and rationale of voluntary blood donation shall be included and given
emphasis in health subjects of schools, both public and private, at the elementary, high school and college
levels. The Department of Education, Culture and Sports shall also require such inclusion in its non-formal
education curricula.
(c) Professional Education. — The Department, the PBCC, the Philippine Society of Hematology and Blood
Transfusion (PSHBT), the Philippine Society of Pathologists (PSP), the Philippine Medical Association (PMA), the
Philippine Association of Medical Technologists (PAMET) and the Philippine Nursing Association (PNA) are
encouraged to conduct for their respective members and as part of the continuing medical education, trainings
on the rational use of blood and blood products including the merits of voluntary blood donation.
(d) Establishment of Blood Services Network. — Blood centers shall be strategically established in every province and
city nationwide within the framework of a National Blood Transfusion Service Network spearheaded by the
Department, in coordination with the PNRC. The collection of blood in various areas in the community, such as
schools, business enterprises, barangays, and military camps shall be promoted. The Secretary shall set the
standards for the scientific and professional establishment and operation of blood banks/centers and collection
units. The Department shall provide training programs and technical assistance to enable communities, schools,
industrial and business sites, barangays, military camps and local government units to implement their own
voluntary blood donation programs.
(e) Walking Blood Donors. — In areas where there may be inadequate blood banking facilities, the walking blood
donor concept shall be encouraged and all government hospitals, rural health units, health centers and barangays
in these areas shall be required to keep at all times a list of qualified voluntary blood donors with their specified
blood typing.

Section 5. National Voluntary Blood Services Program. — The Department, in cooperation with the PNRC and PBCC and
other government agencies and non-governmental organizations shall plan and implement a National Voluntary Blood
Services Program (NVBSP) to meet in an evolutionary manner, the needs for blood
transfusion in all regions of the country. Funds for this purpose shall be provided by the Government through
the budgetary allocation of the Department, by the Philippine Charity Sweepstakes Office (PCSO) with an initial amount of
at least Twenty-five million pesos (₱25,000,000), by the Philippine Amusement and Gaming Corporation (PAGCOR) with an
initial amount of at least Twenty-five million pesos (₱25,000,000), by the trust liability account of the Duty Free Shop (Duty
Free Philippines) with an initial amount of at least Twenty million pesos (₱20,000,000) and through contributions of other
agencies such as civic organizations.

Section 6. Upgrading of Services and Facilities. — All blood banks/centers shall provide preventive health services such as
education and counselling on blood transfusion transmissible diseases. All government hospitals, including those that have
been devolved, shall be required to establish voluntary blood donation programs and all private hospitals shall be
encouraged to establish voluntary blood donation programs.
The Department, in consultation with the PSHBT and the PSP, shall also establish guidelines for the rational use of blood
and blood products.

Section 7. Phase-out of Commercial Blood Banks. — All commercial blood banks shall be phased-out over a period of two
(2) years after the effectivity of this Act, extendable to a maximum period of two (2) years by the Secretary.

Section 8. Non-Profit Operation. — All blood banks/centers shall operate on a non-profit basis: Provided, That they may
collect service fees not greater than the maximum prescribed by the Department which shall be limited to the necessary
expenses entailed in collecting and processing of blood. Blood shall be collected from healthy voluntary donors only.

Section 9. Regulation of Blood Services. — It shall be unlawful for any person to establish and operate a blood bank/center
unless it is registered and issued a license to operate by the Department: Provided, That in case
of emergencies, blood collection and transfusion under the responsibility of the attending physician shall be allowed in
hospitals without such license under certain conditions prescribed by the Department. No license shall be granted or
renewed by the Department for the establishment and operation of a blood bank/center unless it complies with the
standards prescribed by the Department. Such blood bank/center shall be under the management of a licensed and
qualified physician duly authorized by the Department.

Section 10. Importation of Blood Bank Equipment, Blood Bags and Reagents. — Upon the effectivity of this Act, equipment,
blood bags and reagents used for the screening and testing of donors, collection and processing and storage of blood shall
be imported tax-and duty-free by the PNRC, blood banks and hospitals participating actively in the National Voluntary Blood
Services Program. This provision shall be implemented by the rules and regulations to be promulgated by the Department in
consultation and coordination with the
Department of Finance.

Section 11. Rules and Regulations. — The implementation of the provisions of this Act shall be in accordance with the rules
and regulations to be promulgated by the Secretary, within sixty (60) days from the approval hereof. The existing Revised
Rules and Regulations Governing the Collection, Processing and Provision of Human Blood and the Establishment and
Operation of Blood Banks shall remain in force unless amended or revised by the Secretary. The rules and regulations shall
prescribe from time to time the maximum ceiling for fees for the provision of blood, including its collection, processing and
storage, professional services and a reasonable allowance for spoilage.

Section 12. Penalties. — Upon complaint of any person and after due notice and hearing, any blood
bank/center which shall collect charges and fees greater than the maximum prescribed by the Department shall have its
license suspended or revoked by the Secretary.
Any person or persons who shall be responsible for the above violation shall suffer the penalty of imprisonment of not less
than one (1) month nor more than six (6) months, or a fine of not less than Five thousand pesos (P5,000) nor more than
Fifty thousand pesos (₱50,000), or both at the discretion of the competent court.
Any person who shall establish and operate a blood bank without securing any license to operate from the Department or
who fails to comply with the standards prescribed by the Department referred to in Section 9 hereof shall suffer the
penalty of imprisonment of not less than twelve (12) years and one (1) day nor more than twenty (20) years or a fine of not
less than Fifty thousand pesos (₱50,000) nor more than Five hundred thousand pesos (₱500,000), or both at the discretion
of the competent court.
The Secretary, after due notice and hearing, may impose administrative sanctions such as, but not limited to fines,
suspension, or revocation of license to operate a blood bank/center and to recommend the suspension or revocation of
the license to practice the profession when applicable.
The head of the blood bank and the necessary trained personnel under the head's direct supervision found responsible for
dispensing, transfusing and failing to dispose, within forty-eight (48) hours, blood which have been proven contaminated
with blood transfusion transmissible diseases shall be imprisoned for ten (10) years. This is without prejudice to the filing
of criminal charges under the Revised Penal Code. 1a⍵⍴h!1

Section 13. Separability Clause. — If any provision of this Act is declared invalid, the other provisions hereof not affected
thereby shall remain in force and effect.

Section 14. Repealing Clause. — This Act shall supersede Republic Act No. 1517 entitled "Blood Bank Act." The provisions of
any law, executive order, presidential decree or other issuances inconsistent with this Act are hereby repealed or modified
accordingly.

Section 15. Effectivity Clause. — This Act shall take effect after fifteen (15) days following its publication in the Official
Gazette or in two (2) national newspapers of general circulation.

DOH ADMINISTRATIVE ORDER NO. 2008-0008

• “Rules and Regulations Governing the Regulation of Blood Service Facilities”
• Approved – May 02, 2008

I. BACKGROUND/RATIONALE

Republic Act 7719 otherwise known as the "National Blood Services Act or was passed to ensure safe and
efficient Blood Banking and transfusion practices is the Philippines. To carry out the provisions of Republic Act 7719,
Administrative Order No. 9 1995 "Rules and Regulations Implementing Republic Act 7719" was
formulated. Chapter VIII of the said Administrative Order addresses the regulation of blood services by the Bureau of
Research and Laboratories. This was amended by Administrative Order No. 17 As. 1998 otherwise known as the
"Requirements and Procedures for a License to Operate a BB/BC in the Philippines” The Rules and Regulations Governing
Authorization of BCU and BS was formulated and approved in 2003.

In January 2005, Administrative Order No. 2005-0002 "Rules and Regulations for the Establishment of the Philippine
National Blood Services Amending Pertinent Provisions of Administrative Order No. 9, s. 1995" was formulated pursuant to
Sections 5 and 6 of RA 77-I9 This Administrative Order established the National Council for Blood Services and the
Philippine National Blood Services. It also defined the new functions and/or service capabilities of the different blood
service facilities, including hospital BBs and BCs, as well as those of the end- user hospitals and other health facilities. With
these newly delineated functions and service capabilities of- blood service facilities. It is imperative that relevant provisions
of A.O. No. 9 s. 1995 and A.O. 17-A s. 1998 be revised.
Regulation is one of the main thrusts of current health sector reforms under FOURmula One (F1) for health. The main
objective of regulatory reforms is to ensure access to quality and affordable health products, devices, facilities and services,
especially those commonly used by the poor. It is the responsibility of the state to provide the public with safe and
adequate blood through an efficient blood services network. With the
separation of the regulatory functions from the programming functions, it is envisioned that the goals of the national
voluntary blood services program shall be better achieved.

II. OBJECTIVE

These rules and regulations are promulgated to protect and promote the health of the people by ensuring available
licensed blood service facilities with adequate staff, equipment and resources to perform all the required functions
safely, efficiently and effectively.

III. SCOPE

The rules and regulations embodied herein shall apply to all government and private blood service facilities engaged in blood
banking and transfusion services.

IV. DEFINITION OF TERMS

A. Act - Republic Act (R.A.) 7719, also known as the National Blood Services Act of 1994, unless herein specified.
B. ATO - refers to the Authority to Operate. It is a format permit issued by the DOH-CHD to an individual,
partnership, corporation or association to a BCU/BS.
C. BB refers to the Blood Bank
D. BC - refers to the Blood Center
E. BHFS - refers to the Bureau of Health Facilities and Services
F. Blood- refers to the human blood for transfusion
G. Blood Component - refers, but not limited to whole blood, red cells, granulocytes plasma, platelets,
cryoprecipitate and cryosupernate prepared in a BC.
H. BCU - refers to the Blood Collection Unit
I. Blood Product - a therapeutic substance derived from whole blood or plasma.
J. BS - refers to the Blood Station
K. BSF - refers to the blood service facility. It is a unit, agency or institution providing blood products. The types of
BSF are BS, BCU, Hospital BB and BC (Regional, Sub-national and National).
L. Blood Services Network - an organization composed of the designated BCs, hospital BBs, BCUs, BSs, end-user
hospitals, and other health facilities established to provide for the blood needs of a specific geographical area.
M. CHD - refers to the Center for Health Development which is the DOH Regional Field Office.
N. DOH-refers to the Department of Health.
O. End-User Hospital - a hospital with a licensed clinical laboratory capable of red cell typing and cross- matching
and which does not have any BSF but only receives blood and blood components for blood transfusion as needed.
P. End-User Non-hospital Health Facility - a licensed/accredited non-hospital health facility without a licensed clinical
laboratory but administers blood transfusion such as a dialysis clinic and birthing home under the supervision of a
licensed physician/s.
Q. EQAS - refers to the External Quality Assessment Scheme
R. HBTC - refers to the Hospital Blood Transfusion Committee
S. LTO - refers to the License to Operate. It is a formal authority issued by the DOH to an individual,
partnership, corporation or association to operate a BB/BC.
T. NCBS - refers to the National Council for Blood Services.
U. NVBSP- refers to the National Voluntary Blood Services Program
V. PNRC- refers to the Philippine National Red Cross
W. TTI- refers to the Transfusion-Transmitted Infections
X. Voluntary, Non-Remunerated Blood Donor - a donor who gives blood freely voluntarily without receiving money or
any form of payment.

V. POLICIES AND GUIDELINES

A. General Guidelines

1. EVERY BSF shall be an integral part of a blood services network and guided by administrative issuances
governing the establishment and operation of blood services networks.
a. Each BC shall have responsibility for and authority over the conduct and close supervision of the
BCU/BS affiliated with its Blood Service Network.
b. The head of the BC or his designated staff shall conduct on site periodic evaluation of each affiliated
BB, BCU and BS.
2. All BSF are required to comply with the standards and technical requirements embodied in the
inspection tools. It shall be posted at the DOH website [Link]
3. Blood shall be collected from qualified healthy voluntary non-remunerated blood donors only.
4. 4 Testing for TTIs shall be based on the DOH prescribed methodology. The number of infections to be screened as
well as the method for their detection shall be determined and reviewed periodically by the NCBS.
5. Testing for TTls shall be done at the National, Sub-national and designated Regional BCs including PNRC BCs.
Such designation shall be determined by the NCBS pursuant to AO 2005-0002.
6. All units of blood issued by the Philippine BC, Sub-national BCs, Regional BCs, and PNRC under the Philippine
Blood Services Network shall not be retested for TTls by the end-user hospitals and other health facilities. It is
the responsibility of the issuing BCs to ensure that all units of blood issued have been tested and found to be
negative to TTls.
7. Blood and blood products for transfusion shall be obtained from licensed and authorized BSF only.

B. Specific Guidelines

1. Classification of BSF

a. Ownership
1. Government - operated and maintained partially or wholly by a national, provincial, city or
municipal government or other political unit, by any department, division, board or agency
thereof or by a government owned or controlled corporation.
 2. Private - (for hospital-based BSF only) - privately owned, established and operated with
funds through donation, capital or other means, by an individual, corporation, association,
or organization.

b. Institutional Character

1. Hospital-based - a BSF located within the premises of a hospital.

2. Non-hospital-based - a government-owned or PNRC-owned BSF located outside the premises
of a hospital consistent with the NVBSP Strategic Plan

c. Service Capability

1. BS
a. Advocacy and promotion of voluntary blood donation and healthy lifestyle;
b. Provision of whole blood and packed red cells;
c. Storage, issuance, transport and distribution of whole blood and packed red cells;
d. Compatibility testing of red cell units, if hospital based.

2. BCU
a. Advocacy and promotion of voluntary blood donation and healthy lifestyle;
b. Recruitment, retention, and care of voluntary blood donors;
c. Screening and selection of voluntary blood donors;
d. Conduct of health education and counselling services;
e. Collection of blood (mobile or facility-based) from qualified voluntary blood
donors;
f. Transport of Blood to BC for testing and processing;
g. Compatibility testing of red cell units, if hospital based.

3. BCU/BS - all services stipulated under BCU and BS

4. BB
a. Advocacy and promotion of voluntary blood donation and healthy life;
b. Storage and issuance of whole blood and blood components obtained from a BC;
c. The following services shall also be provided:
i. Compatibility testing and red cell units;
ii. Direct Coombs Test;
iii. Red cell antibody screening;
iv. Investigation of transfusion reactions;
v. Assist the HBTC in the conduct of post-transfusion surveillance
(hemovigilance)

5. BC
a. Advocacy and promotion of voluntary blood donation and healthy lifestyle;
b. Recruitment, retention and care of voluntary blood donors;
c. Collection of blood (mobile or facility-based) from qualified voluntary blood
donors;
d. Conduct health education and counselling;
e. Testing of units of blood for TTIs;
f. Processing and provision of blood components;
 g. Storage, issuance, transport and distribution of units of whole blood and/or blood
products to hospitals and other health facilities.

2. Standards and Technical Requirements

a. The BSF appoints and allocates personnel who are suitably qualified, skilled and/or trained to assume
the responsibilities, authority, accountability and functions of the position.
b. Services are provided in an environment that promotes safety, has adequate space, meets the needs of
clients, service providers and other stakeholders, and conforms to the current Manual of Standards issued
by the DOH.
c. All equipment and instruments necessary for the safe and effective provision of services are available
and are properly maintained.
d. All reagents and glassware to be used by the BSF shall be based on the minimum requirement for
sensitivity and specificity of testing reagents as well as the testing procedures as recommended by the
technical committee of the NVBSP.
e. There shall be a system of reporting and recording of results of BSF examinations.
f. The BSF shall put into practice a quality assurance program.
1. There shall be a policy on quality assurance program and continuous quality
improvement
2. The BSF shall participate in an External Quality Assessment Program administered by the
designated National Reference Laboratories (NRL) or other external assessment program
approved by the DOH-NVBSP.
g. There shall be a system in outsourcing of examinations and blood components.
h. All hospital-based BB, BCU and/or BS shall establish a HBTC.
i. All BSF shall comply with policies and guidelines of the NVBSP.

3. LTO/ATO
a. Hospital based BBs, BCUs, BS shall be licensed or authorized to operate through the One- Stop-Shop
Licensure for Hospitals and are therefore not required to obtain a separate LTO or ATO. The required
documents for the licensure of the BB or the authorization of the BCU or BS shall be submitted to the
along with other documentary requirements for the hospital LTO.
b. The LTO/ATO shall be granted in accordance with prescribed documentary and technical
requirements and on the basis of specific conditions and limitations established during
inspection.
c. The LTO/ATO as well as any right under the license/authorization cannot be assigned or
otherwise transferred directly or indirectly to any party.
d. The LTO/ATO must be displayed at all times at a prominent place within the premises.
e. The CHD shall be notified within fifteen (15) calendar days of any change in management, name or
ownership. In cases of transfer of location, a new application for LTO/ATO shall be required.
f. A separate LTO/ATO shall be required for each BSF or branch maintained in separate premises even if
operated by the same management.

4. Maximum Allowable Service Fees

a. The BSF may collect a reasonable service fee for every blood/blood product issued, which shall not be
greater than the maximum fees prescribed by the DOH. The NVBSP shall periodically review the
maximum allowable service fee specifying the basic requirements and special tests covered by the service
fee.
b. The prescribed maximum allowable fees shall be placed in an area readily seen by the public.
 c. The basic donor screening and blood testing procedures shall be determined by the NVBSP through
analysis of research information such as disease prevalence studies and risk estimates, consultation with
the technical experts, and careful evaluation of the optimum benefits from the expected cost of these
tests.

VI. PROCEDURAL GUIDELINES

A. Application for LTO for BCs and BBs and ATO for BCU and BS

1. Applicant requests for relevant information and prescribed form from the CHD un whose
jurisdiction the proposed BSF is located, in person or through mail, email or intern
2. Applicant accomplished required documents and submits them to the CHD.
Documentary requirements for the issuance of LTO/ATO.
a. Certificate of inclusion in the Regional Blood Services Network approved by the
identified Lead Blood Center in the region
b. Duly accomplished and notarized Application Form
c. DTI/SEC registration (initial)
d. List of personnel with photocopy of valid PRC card
e. Location map (initial)
f. Floor diagram
g. List of equipment - with serial number, brand, date of purchase, number of units and
operational status
h. NVBSP Annual Blood Report (renewal)
i. Certificate of participation in EQAS in previous year (renewal)
3. The CHD Director or his authorized representative/s reviews documents for completeness,
authenticity and compliance with the requirements.
4. The applicant pays the appropriate fees, based on the current prescribed DOH schedule of fees, to the
CHD Cashier in person or through postal money order, BSF operating as BCU/BS shall be charged the
corresponding fee for BCU.

2. Inspection

1. The CHD Director or his authorized representative(s) inspects the BSF within thirty (30) calendar days
from the time of application to determine compliance with standards and technical requirements.
2. The CHD inspection team prepares official summary of findings and recommends approval or
disapproval after inspection.

3. Issuance of LTO/ATO

1. The CHD Director approves or disapproves the issuance of LTO/ATO.

a. If approved, the BSF is registered and an LTO/ATO is issued to the applicant within fifteen
(15) calendar days.
b. If disapproved, a copy of inspection findings and recommendations is provided to the
applicant within fifteen (15) days from the time of inspection.
c. An application for an LTO/ATO that is not processed within the thirty (30) calendar day period
is considered approved.

4. Renewal of LTO/ATO
 1. The LTO/ATO shall be renewed every three (3) years. All hospitals BSF shall renew their LTO/ATO
annually as part of the One-Stop-Shop licensure for hospitals.
2. Application for renewal of LTO/ATO shall be filed on the first day of October until the last day of
November on the last year of the LTO validity period to the CHD under which jurisdiction the BSF is
located.
3. The LTO/ATO may be renewed only if it complies with the prescribed standards and technical
requirements.

VII. VALIDITY OF LICENSE TO OPERATE

The LTO/ATO to operate a BSF shall be valid for a period of three (3) years, beginning on January 1 of the first year of the
validity period to December 31 of the third year of the validity period.

As part of the hospital license to operate, the license to operate/authority to operate a BB/BCU/BS shall be valid for a
period of one (1) year, beginning January 1 to December 31.

VIII. MONITORING

The BHFS/CHD Director or his authorized representative/s is authorized to monitor and conduct on-site visits to the BSF
at any given time. The BSF shall make available to the monitoring team all pertinent records to determine the level of
compliance with the National Blood Services Act and these rules and regulations.

IX. VIOLATIONS

Violations of the National Blood Services Act or the rules and regulations issued in pursuance thereto, include the
commission of the following acts by individual, corporation, association, or organization operating the BSF, or persons under
their authority:

A. Any material false statement in the application.

B. Misrepresentation of facts or falsification of documents or records.
C. Refusal to make available its books, accounts and records of operation to an authorized person from the
BHFS/CHD.
D. Charging of blood service fees above the maximum fees set by the DOH.
E. Collection of blood from paid or remunerated donor whether payment comes from the hospital or from the
patient/relatives.
F. Refusal to participate in EQAS conducted by the designated National Reference Laboratories.

X. TRANSITORY PROVISIONS

All previously licensed hospital based and PNRC BCs already performing the blood testing and processing shall be allowed
to operate as such until December 31, 2009. by 2010, there shall be a nationally coordinated blood service network with
only the designated BCs performing the centralized testing and processing.
 XI. INVESTIGATION AND HEARING OF CHARGES OR COMPLAINTS

Upon filing of charges or complaints duly sworn to by any individual, corporation, association, or organization against any
BSF or any of its personnel who has violated or is violating the provisions of R.A. 7719 or any of these rules and
regulations, the BHFS/CHD director or his authorized representative/s shall investigate and verify if the BSF concerned or
any of its personnel is guilty of the charges or complaints. If upon investigation and hearing, the BSF concerned or any of
its personnel is found violating the provisions of R.A. 7719 or any of these rules and regulations, the CHD Director shall
suspend the LTO/ATO for a definite or indefinite period of time, or revoke the LTO/ATO without prejudice to taking the case
to judicial authorities for criminal action.

XII. SUSPENSION REVOCATION OF LICENSE/AUTHORITY TO OPERATE

An LTO/ATO shall be suspended or revoked by the CHD Director upon violation of the National Blood Services Act or the rules
and regulations issued in pursuance thereto. The CHD Director shall notify the BSF concerned or any of its personnel by
registered mail the particular reasons for the denial or revocation of LTO/ATO.

XIII. APPEAL

Any BSF or any of its personnel aggrieved by the decision of the CHD Director may, within thirty (30) calendar days after
receipt of notice of the decision, file a notice of appeal with the Office of the Secretary through the BHFS, and serve a copy
of the notice of appeal to the CHD. Thereupon, the CHD Director shall promptly
certify and file a copy of the decision, including the transcript of the hearings on which the decision is based, with the
Office of the Secretary for review. The decision of the Office of the Secretary shall be final and executory.

XIV. CLOSURE

The CHD Director or his authorized representative/s shall immediately close all BSF without an LTO/ATO and may seek
assistance of any government agency to effectively enforce the closure.

XV. PENAL PROVISION

A. Upon conviction, any BSF that collects service fees greater than the maximum prescribed by the DOH shall have
its LTO/ATO suspended or revoked by the CHD Director Any individual, corporation, association, or organization
who is responsible for the above violation shall suffer the penalty of imprisonment of not less than one (1) month
but not more than six (6) months, or a fine of not less than five thousand pesos (P5.000), or both at the discretion
of the judicial authority.

B. Any individual, corporation, association, or organization who establishes and manages a BSF without securing the
necessary LTO/ATO from the CHD, or violates any provision of these rules and regulations shall suffer the penalty of
imprisonment of not less than twelve (12) years but not more than twenty (20) years, or a fine of not less than fifty
thousand Pesos (P50,000) but not more than five hundred thousand pesos (P500,000), or both at the discretion of
the judicial authority.
 C. The head of the BSF and the personnel responsible for dispensing or transfusing unscreened, incompletely
tested and/or contaminated blood or failing to dispose within forty-eight (48) hours blood that is contaminated
with transfusion transmissible infections after receipt of confirmatory testing result from the Research Institute
of Tropical Medicin National Reference Laboratory shall be imprisoned for ten (10) years. This shall be without
prejudice to the filing of criminal charges under the Revised Penal Code.

D. The CHD Director, after due notice and hearing, and upon approval of the Secretary may impose the following
administrative sanctions:

1. Penalty of five thousand pesos P5,000 for any BSF that fails to submit the application for renewal of
LTO/ATO to the CHD within three (3) months prior to the expiration of the existing license,

2. Recommendation to the PRC to revoke the certificate of registration or to invalidate the license of any
health professional found violating the provisions of R.A. 7719 or of these rules and regulations.

XVI. PUBLICATION

A list of licensed/authorized BSF according to their classification shall be published or posted a the DOH website annually.

XVII. SEPARABILITY CLAUSE

In the event that any provision or part of this Order be declared unauthorized or rendered invalid by any court of law or
competent authority, those provisions not affected by such declaration shall remain valid and
effective.

XVIII. REPEALING CLAUSE

These rules and regulations shall repeal and supersede all administrative orders and previous issuances inconsistent thereof.

XIX. EFFECTIVITY

These rules and regulations shall take effect fifteen (15) days after publication in a newspaper of general circulation.
THE “PHILIPPINE 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 Therefor
• Approved – December 20, 2018
• 1989 - Mandatory HIV screening test for blood units pursuant to AO No. 57 s.1989

Section 1. Short Title. - This Act shall be known as the "Philippine HIV and AIDS Policy Act".

Section 2. Declaration of Policies. - The Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome
(AIDS) are public health concerns that have wide-ranging social, political, and economic repercussions. Responding to the
country's HIV and AIDS situation is therefore imbued with public interest and shall be anchored on the principles of human
rights upholding human dignity.

Policies and practices that discriminate on the basis of perceived or actual HIV status, sex, gender, sexual orientation,
gender identity and expression, age, economic status, disability, and ethnicity hamper the enjoyment of basic human rights
and freedoms guaranteed in the Constitution and are deemed inimical to national interest.

The State shall respect, protect, and promote human rights as the cornerstones of an effective response to the country's
HIV and AIDS situation. Hence, HIV and AIDS education and information dissemination should form part the right to
health.

The meaningful inclusion and participation of persons directly and indirectly affected by the HIV and AIDS situation,
especially persons living with HIV, are crucial in eliminating the virus. Thus, unless otherwise provided in this Act, the
confidentiality and non-compulsory nature of HIV testing and HIV-related testing shall always be guaranteed and protected
by the State.

Towards this end, the State shall ensure the delivery of non-discriminatory HIV and AIDS services by government and
private HIV and AIDS service providers, and develop redress mechanisms for persons living with HIV to ensure that their
civil, political, economic, and social rights are protected.

Accordingly, the State shall:

(a) Establish policies and programs to prevent the spread of HIV and deliver treatment, care, and support services to
Filipinos living with HIV in accordance with evidence-based strategies and approaches that uphold the principles
of human rights, gender-responsiveness, and age-appropriateness, including meaningful participation of
communities affected by the country's HIV and AIDS situation;
(b) Adopt a multi-sectoral approach in responding to the country's HIV and AIDS situation by ensuring tha the whole
government approach, local communities, civil society organizations (CSOs), and persons living with HIV are at
the center of the process;
(c) Ensure access to HIV- and AIDS-related services by eliminating he climate of stigma and discrimination
that surrounds the country's HIV and AIDS situation, and the people directly and indirectly affected by it;
and
(d) Positively address and seek to eradicate conditions that aggravated the spread of HIV infection, which include
poverty. Gender inequality, marginalization, and ignorance.
Section 3. Definition of Terms. - For the purposes of this Act, the following terms shall be defined as follows:
(a) Acquired Immune Deficiency Syndrome (AIDS) refers to a health condition where these is a deficiency of
immune system that stems from infection with the Human Immunodeficiency Virus or HIV, making an
individual susceptible to opportunistic infections;
(b) Anti-retroviral Therapy (ART) refers to the treatment that stops or suppresses viral replication or
replications of a retrovirus like HIV, thereby slowing down the progression of infection;
(c) Bullying refers to any severe or repeated use by one or more persons of a written, verbal or electronic
expression, or a physical act of gesture, or any combination thereof, directed at another person that has the
effect of actually causing or placing the latter in reasonable fear of physical or emotional harm or damage
to one's property; creating a hostile environment for the other person; infringing on the rights of another
persons; or materially and substantially disrupting the processes or orderly operation of an institution or
organization;
(d) Civil Society Organizations (CSOs) refer to groups of nongovernmental and noncommercial individuals
or legal entities that are engaged in non-coerced collective action around shared interests, purpose
and values;
(e) Community-Based Research refers to study undertaken in community settings, which involve
community members in the design and implementation of research projects;
(f) Comprehensive Health Intervention for Key Populations refers to evidence-based policies, programs, and
approaches that aim to reduce transmission of HIV and its harmful consequences on health, social
relations and economic conditions;
(g) Compulsory HIV Testing refers to HIV testing imposed upon an individual characterized by lack of consent,
use of force or intimidation, the use of testing as a prerequisite for employment or other purposes, and
other circumstances when informed choice is absent;
(h) Discrimination refers to unfair or unjust treatment that distinguishes, excludes, restricts, or shows
preferences based on any ground such as sex gender, age, sexual orientation, gender identity and expression,
economic status, disability, ethnicity, and HIV status, whether actual or perceived, and which has the purpose
or effect of nullifying or impairing the recognition, enjoyment or exercise by all persons similarly situated, of
all their rights and freedoms;
(i) Evolving Capacities of the Child refers to the concept enshrined in Article 5 of the Convention on the Rights
of the Child recognizing the developmental changes and the corresponding progress in cognitive abilities and
capacity for self-determination undergone by children as they grow up, thus requiring parents and others
charged with the responsibility for the child to provide varying degrees of protection, and to allow their
participation in opportunities for autonomous decision-making;
(j) Gender Expression refers to the way a person communicates gender identity to others through behavior,
clothing, hairstyles, communication or speech pattern, or body characteristics;
(k) Gender Identity refers to the personal sense of identity as characterized, among others, by manner of
clothing, inclinations, and behavior in relation to masculine or feminine conventions. A person may have a
male or female identity with the physiological characteristics of the opposite sex;
(l) Health Maintenance Organizations (HMO) refers to juridical entities legally organized to provide or arrange for
the provision of pre-agreed or designated health care services to its enrolled members for a fixed pre-paid fee
for a specified period of time;
(m) High-risk Behavior refers to a person's involvement in certain activities that increase the risk of
transmitting or acquiring HIV;
(n) Human Immunodeficiency Virus (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. Infection with HIV results in the
progressive deterioration of the immune system. Leading to immune deficiency;
(o) HIV Counseling refers to the interpersonal and dynamic communication process between a client and a
trained counselor, who is bound by a code of ethics and practice to resolve personal, social,or psychological
 problems and difficulties, and whose objective in counseling in the context of an HIV diagnosis is to
encourage the client to anxiety and stress, plan for the future (keeping healthy, the context of a negative HIV
test result, to encourage the client to explore motivations, options, and skills to stay HIV-negative;
(p) HIV and AIDS Counselor refers to any individual trained by an institution or organization accredited by the
Department of Health (DOH) to provide counseling services on HIV and AIDS with emphasis on behavior
modification;
(q) HIV and AIDS Monitoring refers to the documentation and analysis of the number of HIV and AIDS infections
and the pattern of its spread;
(r) HIV and AIDS Prevention and Control refers to measures aimed at protecting non-infected persons from
contracting HIV and minimizing the impact of the condition on persons living with HIV;
(s) HIV-Negative refers to the absence of HIV or HIV antibodies upon HIV testing;
(t) HIV-Positive refers to the presence of HIV infection as documented by the presence of HIV and HIV
antibodies in the sample being tested;
(u) HIV Testing refers to any facility-based, mobile medical procedure, or community-based screening modalities
that are conducted to determine the presence or absence of HIV in a person's body. HIV testing is
confidential, voluntary in nature and must be accompanied by counseling prior to and
after the testing, and conducted only with the informed consent of the person;
(v) HIV-related Testing refers to any laboratory testing or procedure done or an individual in relation to a
person's HIV condition;
(w) HIV Testing Facility refers to any DOH accredited on-site or mobile testing center, hospital, clinic, laboratory,
and other facility that has the capacity to conduct voluntary HIV counseling and HIV testing;
(x) HIV Transmission refers to the transfer of HIV from one infected person to an uninfected individual, through
unprotected sexual intercourse, blood transfusion, sharing of contaminated intravenous needles, or which
may occur during pregnancy, delivery, and breastfeeding;
(y) 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;
(z) Key Affected Populations refers to those groups or persons at higher risk of HIV exposure, or affected
populations whose behavior make them likely to be exposed to HIV or to transmit the virus;
(aa) Laboratory refers to an area or place, including community-based settings, where research studies are being
undertaken to develop local evidence for effective HIV response;
(bb) Mature Minor Doctrine 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;
(cc) 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.
The patient's health status can, however, be shared with other medical practitioner involved in the
professional care of the patient, who will also be bound by medical confidentiality. Medical confidentiality
applies to the attending physician, consulting medical specialist, nurse, medical technologist and all other
health workers or personnel involved in any counseling, testing or professional care of the patient. It also
applies to any person who, in any officially capacity, has acquired or may have acquired such confidential
information;
(dd) Opportunistic infections refer to illnesses caused by various organism, many of which do not cause diseases
in persons with healthy immune system;
(ee) Partner Notification refers to the process by which the "index client", "source", or "patient" who has a sexually
transmitted infection (STI) including HIV, is given support in order to notify and advise
 the partners that have been exposed to infection. Support includes giving the index client a mechanism to
encourage the client's partner to attend counseling, testing and other prevention and treatment services.
Confidentiality shall be observed in the entire process;
(ff) Person Living with HIV (PLHIV) refers to any individual diagnosed to be infected with HIV;
(gg) Pre-exposure Prophylaxis refers to the use of prescription drugs as a strategy for the prevention of HIV
infection by people who do not have the HIV and AIDS. It is an optional treatment, which may be taken by
people who are HIV-negative but who have substantial, higher-than-average risk of contracting an HIV
infection;
(hh) Pre-test Counseling refers to the process of providing an individual with information on the
biomedical aspects of HIV AIDS, and emotional support to any psychological implications of
undergoing HIV testing and the test result itself before the individual is subjected to the test;
(ii) Post-exposure Prophylaxis refers to a preventive medical treatment started immediately after exposure to
pathogen (HIV) in order to prevent infection by the pathogen and the development of the disease;
(jj) Post-test Counseling refers to the process of providing risk-reduction information and emotional support
to a person who submitted to HIV testing at the time the result is released;
(kk) Prophylactic refers to any agent or device used to prevent the transmission of an infection;
(ll) Provider-initiated Counseling and Testing refers to a health care provider initiating HIV testing to a person
practicing high-risk behavior or vulnerable to HIV after conducting HIV pre-test counseling. A person may
elect to decline or defer testing such that consent is conditional;
(mm) Redress refers to an act of compensation for unfairness, grievance, and reparation;
(nn) Safer Sex Practices refers to choices made, and behaviors adopted by a person to reduce or minimize the
risk of HIV transmission. These may include postponing sexual debut, non- penetrative sex, correct and
consistent use of male or female condoms. And reducing the number of sexual partners;
(oo) Sexually Transmitted Infections (STIs) refers to infections that are spread through the transfer of
organisms from one person to another as a result of sexual contact;
(pp) Sexual Orientation refers to the direction of emotional, sexual attraction, or conduct towards people of the same
sex (homosexual orientation) or towards people of both sexes (bisexual orientation) or towards people of the
opposite sex (heterosexual orientation) or to the absence of sexual attraction (asexual orientation);
(qq) Social Protection refers to a set of policies and programs designed to reduce poverty and vulnerability
by promoting efficient labor markets, diminishing people's exposure to risks, and enhancing their
capacity to protect themselves against hazards, and interruptions on, or loss of income;
(rr) Stigma refers to the dynamic devaluation and dehumanization of an individual in the eyes of others, which may
be based on attributes that are arbitrarily defined by others as discreditable or unworthy, and which results in
discrimination when acted upon;
(ss) Treatment hubs refer to private and public hospitals or medical establishments accredited by the DOH to
have the capacity and facility to provide treatment and care services to PLHIV;
(tt) Voluntary HIV testing refers to HIV testing done on an individual who, after having undergone pre- test
counseling willingly submits to such test;
(uu) Vulnerable communities refer to the communities and groups suffering from vulnerabilities such as unequal
opportunities, social exclusion, poverty, unemployment, and other similar social exclusion, poverty,
unemployment, and other similar social economic, cultural and political conditions making them more
susceptible to HIV infection and to developing AIDS; and
(vv) Workplace refers to the office, premise or work site where workers are habitually employed and shall
include the office or place where workers, with no fixed or definite work site, regularly report for
assignment in the course of their employment.
 ARTICLE I
THE PHILIPPINE NATIONAL AIDS COUNCIL

Section 4. Philippine National AIDS Council (PNAC). - the PNAC, established under Section 43 of Republic Act No. 8504,
otherwise known as the "Philippine AIDS Prevention and Control Act of 1998", shall be reconstituted and streamlined to
ensure the implementation of the country's response to the HIV and AIDS situation.

The PNAC shall be an agency attached to the DOH with a separate budget under the General Appropriations Act (GAA). It
shall have its own secretariat and staffing pattern that shall be headed by an executive director.

Section 5. Functions. - The PNAC shall perform the following functions;

(a) Develop the AIDS Medium Term Plan (AMTP) in collaboration with relevant government agencies, CSOs, the
PLHIV community, and the other stakeholders;
(b) Ensure the operationalization and implementation of the AMTP;
(c) Strengthen the collaboration between government agencies and CSOs involved in the implementation of the
national HIV and AIDS response, including the delivery of HIV and AIDS related services;
(d) Develop and ensure the implementation of the guidelines and policies provided in this Act, including other
policies that may be necessary to implement the AMTP;
(e) Monitor the progress of the response to the country's HIV and AIDS situation;
(f) Monitor the implementation of the AMTP, undertake mid-term assessments and evaluate its impact;
(g) Mobilize sources of funds for the AMTP;
(h) Mobilize its members to conduct monitoring and evaluation of HIV-related programs, policies, and services
within their mandate;
(i) Coordinate, organize, and work in partnership with foreign and international organizations regarding funding,
data collection, research, and prevention and treatment modalities on HIV and AIDS, and ensure foreign
funded programs are aligned to the national response;
(j) Advocate for policy reforms to Congress and other government agencies to strengthen the country's response
to the HIV and AIDS situation;
(k) Submit an annual report to the Office of the President, Congress, and the members of the Council;
(l) Identify gaps in the national response on the part of government agencies and its partners from civil society
and international organizations, in order to develop and implement the initial interventions required in these
situations; and
(m) Recommend policies and programs that will institutionalize or continue the interventions required in
addressing the gaps identified in the national response to the HIV and AIDS situation of the country.

In addition to the powers and functions enumerated under the preceding paragraph, the members of the PNAC shall also
develop and implement individual action plans, which shall be anchored to and integrated in the AMTP. Such action plans
shall be based on the duties, powers, and functions of the individual agencies as identified in Articles II to VII of this Act.

Section 6. Memberships and Composition. - Selection of the members of PNAC shall be based on the following criteria:
(a) Government agencies or CSOs with direct contribution to the performance of the core functions of the Council
(oversight, direction setting and policy making);
(b) Government agencies or CSOs with existing programs, services and activities that directly contribute to the
achievement of the AMTP; and
(c) Government agencies or CSOs with existing constituencies that are targeted by the AMTP's objectives and
activities.
The following agencies and CSOs shall be represented in the PNAC:
(1) Department of Health (DOH);
(2) Department of Education (DepEd);
(3) Department of Labor and Employment (DOLE);
(4) Department of Social Welfare and Development (DSWD);
(5) Department of the Interior and Local Government (DILG);
(6) Civil Service Commission (CSC);
(7) Commission on Higher Education (CHED);
(8) National Youth Commission (NYC);
(9) Philippine Information Agency (PIA);
(10) Department of Budget and Management;
(11) The Chairperson of the Committee on Health and Demography of the Senate of the Philippines or his
representative;
(12) The Chairperson of the Committee on Health of the House of Representative or his representative; (13-14)
Two (2) representatives from organizations of persons living with HIV and AIDS;
(15) One (1) representative from a private organization with expertise in standard setting and service delivery; and
(16-21) Six (6) representatives from NGOs working for the welfare or identified key populations.

Except for members from government agencies, the members of the PNAC shall be appointed by the President of the
Philippines. The heads of government agencies may be represented by an official whose rank shall not lower than an
Assistant Secretary or its equivalent.

The members of the PNAC shall be appointed not later than thirty (30) days after the date of the enactment of this Act.

The PNAC shall meet at least once every quarter. The presence of the Chairperson or the Vice Chairperson of the PNAC, and
at least ten (10) other PNAC members and/or permanent representatives shall constitute a quorum to do business, and a
majority vote of those present shall be sufficient to pass resolutions or render decisions.

The Secretary of Health shall be the permanent Chairperson of the PNAC. However, the Vice Chairperson shall be elected
from the government agency members, and shall serve for a term of three (3) years. Members representing CSOs shall serve
for a term of three (3) years renewable upon recommendation of the Council for a maximum of two (2) consecutive terms.

Section 7. Secretariat. - The PNAC shall be supported by a secretariat consisting of personnel with the necessary technical
expertise and capacity that shall be conferred permanent appointments, subject to Civil Service rules and regulations. The
Secretariat shall be headed by an Executive Director who shall be under the direct supervision of the Chairperson of the
PNAC.

The Secretariat shall perform the following functions:

(a) Coordinate and manage the day-to-day affairs of the PNAC;
(b) Assist in the formulation, monitoring, and evaluation of policies and the AMTP;
(c) Provide technical assistance, support and advisory services to the PNAC and its external partners;
(d) Assist the PNAC in identifying and building internal and external networks and partnerships;
(e) Coordinate and support the efforts of the PNAC and its members to mobilize resources;
(f) Serve as the repository of HIV and AIDS-related information;
 (g) Disseminate update, accurate, relevant, and comprehensive information about the country's HIV ad AIDS
situation to PNAC members, policy makers, and the media;
(h) Provide administrative support to the PNAC; and
(i) Coordinate, fund and implement, as directed by the PNAC, the interventions identified by the Council as gaps in
the AMTP implementation, in cooperation with the CSOs and PLHIV community.

Section 8. AIDS Medium Term Plan (AMTP). The PNAC shall formulate and periodically update the six (6)- year AMTP, a
national multi-sectoral strategic plan to prevent and control the spread of HIV and AIDS in the country. The AMTP shall
include the following.
(a) The country's target and strategies in addressing the HIV and AIDS situation;
(b) The prevention, treatment care and support, and other components of the country's response;
(c) The operationalization of the program and identification of the government agencies that shall implement the
program, including the designated office within each agency responsible for overseeing, coordinating,
facilitating, and monitoring the implementation of its AIDS program for the national to the local levels; and
(d) The budgetary requirements and a corollary investment plan of each government agency specified in the AMTP,
and shall identify the sources of funds for its implementation.

Section 9. The Role of DOH. - The National HIV and AIDS and STI Prevention and Control Program (NASPCP) of the DOH,
which shall be composed of qualified medical specialist and support personnel with permanent appointments, and with
adequate yearly budget, shall coordinate with the PNAC for the
implementation of the health sector's HIV and AIDS and STI response as identified in the AMTP.

The Epidemiology Bureau shall maintain a comprehensive HIV and AIDS monitoring and evaluation program that shall
serve the following purposes:
(a) Determine and monitor the magnitude and progression of HIV and AIDS in the Philippines and regularly
provide a list of priority areas with high magnitude of HIV and AIDS cases and co-infections to help the PNAC
evaluate the adequacy and efficacy of HIV prevention and treatment programs being employed;
(b) Receive, collate, process, and evaluate all HIV-and-AIDS-related medical reports from all hospitals, clinics,
laboratories and testing centers, including HIV-related deaths and relevant data from public and private
hospitals, clinics, laboratories and testing centers, including HIV-related deaths and relevant data from public
and private hospitals, various databanks or information
systems; Provided, that it shall adopt a coding system that ensures anonymity and confidentiality; and
(c) Submit, through its Secretariat, quarterly and annual reports to the PNAC containing the findings of its
monitoring and evaluation activities in compliance with this mandate.

Section 10. Protection of Human Rights. - The country's response to the IV and AIDS situation shall be anchored on the
principle of human rights and human dignity. Public health concerns shall be aligned with internationally recognized
human rights instruments and standards.

Towards this end, the members of the PNAC, in cooperation with CSOs, and in collaboration with the
Department of Justice (DOJ) and the Commission on Human Rights (CHR), shall ensure the delivery of non- discriminatory
HIV and AIDS services by government and private HIV and AIDS service provider. Further, the DOJ and CHR, in
coordination with the PNAC, shall take the lead in developing redress mechanisms for PLHIV and key affected
populations to ensure that their civil, political, economic, and social rights are
protected. The PNAC shall cooperate with local government units (LGUs) to strengthen existing mediation and reconciliation
mechanisms at the local level.
 ARTICLE II
INFORMATION, EDUCATION AND COMMUNICATION

Section 11. Prevention Program. - There shall be an HIV and AIDS prevention program that will educate the public on HIV
and AIDS and other STIs with the goal of reducing risky behavior, lowering vulnerabilities, and promoting the human rights
of PLHIV.

The PNAC shall promote and adopt a range of measures and interventions, in partnership with CSOs that aim to prevent,
halt, or control the spread of HIV in the general population, especially among the key populations and vulnerable
communities. These measures shall likewise promote the rights, welfare, and participation of PLHIV and the affected
children, young people, families, and partners of PLHIV.

The HIV and AIDS education and prevention programs shall be age-appropriate and based on up0to-date evidence and
scientific strategies, and shall actively promote:
(a) Safer sec practices among the general population, including sexual abstinence, sexual fidelity, and consistent
and correct condom use especially among key populations;
(b) Other practices that reduce risk of HIV infection;
(c) Universal awareness of and access to evidence-based and relevant information and education, and medically
safe, legally affordable, effective, and quality treatment; and
(d) Knowledge of the health, civil, political, economic, and social rights of PLHIV and their families.

Section 12. Education in Learning Institutions. - Using standardized information and data from the PNAC, the DepEd, CHED,
and the Technical Education and Skills Development Authority (TESDA), shall integrate basic and age-appropriate
instruction on the causes, modes of transmission, and ways of preventing the spread of HIV and AIDS and other STIs in
their respective curricula taught in public and private learning institutions, including alternative and indigenous learning
systems. The learning modules shall include human rights-based principles and information on treatment, care, and
support to promote stigma reduction.

The learning modules that shall be developed to implement this provision shall be done in coordination with the PNAC and stake
holders in the education sector. Referral mechanisms, including but not limited to, the DSWD Referral System, shall be included
in the modules for key populations and vulnerable communities.

The DepEd, CHED, and TESDA shall ensure the development and provision of psychosocial support and counseling in
learning institutions, for the development of positive health, and promotion of values and behavior pertaining to
reproductive health, in coordination with the DOH. For this purpose, funds shall be allocated for the training and
certification of teachers and school counselors.

Section 13. Education for Parents and Guardians. - The DepEd in coordination with parent-teacher organizations in schools
and communities shall conduct awareness-building seminars in order to provide parents and guardians with a gender-
responsive and age-sensitive HIV and AIDS education.

Section 14. Education as Right to Health and Information. - HIV and AIDS education and information dissemination shall
form part of the constitutional right to health.

Section 15. HIV and AIDS Information as a Health Service. - HIV and AIDS education and information dissemination shall
form part of the delivery of health services by health practitioners, workers, and personnel. The knowledge and capabilities
of all public health workers shall be enhanced to include skills for proper information dissemination and education on HIV
and AIDS. It shall likewise be considered a civic duty of health
care providers in the private sector to make available to the public such information necessary to prevent and control the
spread of HIV and AIDS, and to correct common misconceptions about this disease. The training of health workers shall
include discussions on HIV-related ethical issues such as confidentiality, informed consent, and the duty to provide
treatment.

Section 16. Education in the Workplace. - All public and private employers and employees, including members of the Armed
Forces of the Philippine (AFP) and the Philippine National Police (PNP), shall be regularly provided with standardized basic
information and instruction of HIV and AIDS, including topics on confidentiality in the workplace and reduction or
elimination of stigma and discrimination.

The PNAC shall develop the standardized and key messages on the prevention and control of HIV and AIDS based on
current and updated information on the disease.

The DOLE for the private sector, the SCS for the public sector, and the AFP and PNP for the uniformed service shall
implement this provision: Provided, That the standardized basic information and instruction shall be conducted by DOLE for
the private sector at no cost to the employers and employees.

Section 17. Education for Filipinos Going Abroad. - The State shall ensure that all overseas Filipino workers and diplomatic,
military, trade, and labor officials and personnel to be assigned overseas shall attend a seminar on the causes, manner of
prevention, and impact of HIV and AIDS, before being granted a certification for overseas assignment: Provided, That
Filipino workers or to the officials concerned.

The DOLE, the Department of Foreign Affairs (DFA), the Commission on Filipino Overseas (CFO), and other relevant government
agencies in collaboration with the DOH, shall ensure the implementation of this section.

Section 18. Information for Tourists and Transients. - Educational materials on the causes, modes of transmission,
prevention, and consequences of HIV infection and list of HIV counseling testing facilities shall be adequately provided at
all international and local ports of entry and exit. The PIA, together with other relevant government agencies, in
coordination with the PNAC and stakeholders in the tourism industry, shall lead the implementation of this section.

Section 19. Education in Communities. - The DILG, the Union of Local Authorities of the Philippines (ULAP), the League of
Provinces, the League of Cities, and the League of Municipalities, through the local HIV and AIDS Councils (LAC) or the
local health boards and, in coordination with the PNAC, shall implement a locally- based, multi-sectoral community
response to HIV and AIDS through various channels on evidence-based, gender-responsive, age-appropriate, and human
rights-oriented prevention tools to stop the spread of HIV. Gender and Development (GAD) funds and other sources may
be utilized for these purposes.

Indigenous peoples’ communities and geographically isolated and disadvantaged areas (GIDA) shall also be given due
focus in the implementation of this section.

The DILG, in coordination with the DSWD and the NYC, shall also conduct age-appropriate HIV and AIDS education for out-of-
school youth.

Section 20. Education for Key Populations and Vulnerable Communities. - To ensure that HIV services reach key populations
at higher risk, the PNAC, in collaboration with the LGUs and CSOs engaged in HIV and AIDS education programs, such as
peed education, support groups, outreach activities, and community-based research that target these populations and other
vulnerable communities. The DOH shall, in coordination with
appropriate agencies and the PNAC craft the guidelines, and standardized information messages for peer education, support
group, and outreach activities.

Section 21. Information on Prophylactics. - Appropriate information shall be attached to, or provided with every prophylactic
offered for sale or given as donation. Such information shall be legibly printed in English and Filipino and contain literature
on the proper use of the prophylactic device or agent, and its efficacy against HIV and STI.

Section 22. Misinformation on HIV and AIDS. - Misinformation on HIV and AIDS, which includes false and misleading advertising
and claims in any form of media. Including traditional media, internet and social
platform, and mobile applications, of the promotional marketing of drugs, devices, agents or procedures without prior
approval from the DOH through the Food and Drug Administration (FDA), and without the requisite medical and scientific
basis, including markings and indications in drugs and devices or agents, claiming to be a cure or a fail-safe prophylactic
for HIV infection shall be prohibited.

ARTICLE III
PEVENTIVE MEASURES, SAFE PRACTICES AND PROCEDURES

Section 23. HIV Prevention Measure. - The PNAC, in coordination with the DOH, LGUs, and other relevant government
agencies, private sector, CSOs, faith-based organizations, and PLHIVs, shall implement preventive measures, including but
not limited, to the following:
(a) Creation of rights-based and community-led behavior modification programs that seek to encourage HIV risk
reduction behavior among PLHIVs;
(b) Establishment and enforcement of rights-based mechanisms to strongly encourage newly tested HIV- positive
individuals to conduct partner notification and to promote HIV status disclosure to partners;
(c) Establishment of standard precautionary measures in public and private health facilities;
(d) Accessibility of ART and management of opportunistic infections;
(e) Mobilization of communities of PLHIV for public awareness campaigns and stigma reduction activities; and
(f) Establish comprehensive human rights and evidence-based policies, programs, and approaches that aim to
reduce transmission of HIV and its harmful consequences to members of key affected populations.

The enforcement of this section shall not lead to or result in the discrimination or violation of the rights of PLHIV and the
service provider implementing the program, including peer educators and community-based testing providers.

Section 24. Comprehensive Health Intervention for Key Populations. - The DILG and DOH, in partnership with the key
populations, shall establish a human rights and evidence-based HIV prevention policy and program for people who have
higher risk of HIV infection and other key populations.

The presence of used or unused prophylactic shall not be used ad basis to conduct raids or similar police
operations in sites and venues of HIV prevention interventions. The DILG and DOH, in coordination with LGUs, shall establish
a national policy to guarantee the implementation of this provision.

Section 25. Preventing Mother-to-Child HIV Transmission. The DOH shall establish a program to prevent mother-to-
child HIV transmission that shall be integrated in its maternal and child health services.
Section 26. Standard Precaution on the Donation of Blood, Tissue, or Organ. - The DOH shall enforce the following
guidelines on the donation of blood, tissue, or organ:
(a) Donation of tissue or organ, whether gratuitous or onerous, shall be accepted by a laboratory or institution
only after a sample from the donor has been tested negative for HIV;
(b) All donated blood shall also be subjected to HIV testing;
(c) All donors whose blood, organ or tissue has been tested positive shall be deferred from donation, notified of
their HIV status, counselled, and referred for care and clinical management as soon as possible;
(d) Donations of blood, tissue, or organ testing positive for HIV may be accepted for research purposes only, and
shall be subject to strict sanitary disposal requirements; and
(e) A second testing may be demanded as a matter of right by the blood, tissue, or organ recipient or his/her
immediate relatives before transfusion or transplant, except during emergency cases.

Section 27. Testing of Organ Donation. -Lawful consent to HIV testing of a donated human body, organ, tissue, or blood
shall be considered as having been given when:
(a) A person volunteers or freely agrees to donate one's blood, organ, or tissue for transfusion,
transplantation, or research; and
(b) A legacy and a donation are executed in accordance with Sections 3 and 4 respectively, of Republic Act No.
7170, otherwise known as the "Organ Donation Act of 1991".

Section 28. Guidelines on Medical Management, Surgical, and Other Related Procedures. The DOH shall, in consultation
with concerned professional organizations and hospital associations, issue guidelines on medical management of PLHIV
and protocol on precautions against HIV transmission during surgical, dental, embalming, body painting, or tattooing that
require the use of needles or similar procedures. The necessary
protective equipment such as gloves, goggles, and gowns shall be prescribed and required, and made available to all
physicians and health care providers, tattoo artist, and similarly exposed personnel at all times. The DOH shall likewise
issue guidelines on the handling and disposal of cadavers, body fluids, or wastes of persons known or believed to be HIV-
positive.

ARTICLE IV
SCREENING, TESTING AND COUNSELING

Section 29. HIV Testing. - As a policy, the State shall encourage voluntary HIV testing. Written consent from the person
taking the test must be obtained before HIV testing.
HIV testing shall be made available under the following circumstances:
(a) In keeping with the principle of the evolving capacities of the child as defined in Section 3(i) of this Act, if the
person is fifteen (15) to below eighteen (18) years of age, consent to voluntary HIV testing shall be obtained
from the child without the need of consent from a parent or guardian;
(b) In keeping with the mature minor doctrine as defined in Section 3(bb) of this Act, Any young person aged
below fifteen (15) who is pregnant or engaged in high-risk behavior shall be eligible for HIV testing and
counseling, with the assistance of a licensed social worker or health worker. Consent to voluntary HIV testing
shall be obtained from the child without the need of consent from a parent or guardian; and
(c) In all other cases not covered by (b) of this section, consent to voluntary HIV testing shall be obtained from the
child's parent or legal guardian if the person is below fifteen (15) years of age or is mentally incapacitated. In
cases when the child's parents or legal guardian cannot be located despite
 reasonable efforts, or if the child's parent or legal guardian refused to give consent of the minor shall also be
required prior to the testing.

In every circumstance, proper counseling shall be conducted by a social worker, a health care provider, or other health
care professional accredited by the DOH or the DSWD.
HIV testing guidelines issued by the DOH shall include guidance for testing minors and for the involvement of parents or
guardians in HIV testing of minors.

The State shall continually review and revise, as appropriate, the HIV diagnostic algorithm based on current available laboratory
technology and evidence.

Section 30. Compulsory HIV Testing. Compulsory HIV testing shall be allowed only in the following instances:
(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".

Section 31. Mechanisms and Standards on Routine Provider-Initiated and Client-Initiated HIV Counseling and Testing. - To
implement this section, the DOH shall:
(a) Accredit public private HIV testing facilities based on capacity to deliver testing services including HIV
counseling: Provided, that only DOH-accredited HIV testing facilities shall be allowed to conduct HIV testing;
(b) Develop the guidelines for HIV counseling and testing, including mobile HIV counseling and testing, and
routine provider-initiated HIV counseling and testing that shall ensure among others, that HIV testing is
based on informed consent, is voluntary and confidential, is available at all times and provided by the
qualified persons and DOH-accredited providers;
(c) Accredit institutions or organizations that train HIV and AIDS counselors in coordination with DSWD;
(d) Accredit competent HIV and AIDS counselors for persons with disability including but not limited to, translator
for the hearing-impaired and Braille for the visually impaired clients, in coordination with the National Council
for Disability Affairs (NCDA);
(e) Set the standards for HIV counseling and shall work closely with HIV and AIDS CSOs that train HIV and AIDS
counselors and peer educators, in coordination and participation of NGOs, government organizations (GOs),
and Civil Society Organizations of PLHIV (CSO-PLHIV); and
(f) Ensure access to routine provider-initiated counseling and testing as part of clinical are in all health care in
all health care settings for the public.

All HIV testing facilities shall provide free pre-test and post-test HIV counseling to individuals who wish to avail of HIV
testing, which shall likewise be confidential. No HIV testing shall be conducted without informed consent. The State shall
ensure that specific approaches to HIV counseling and testing are adopted based on the nature and extent of HIV and
AIDS incidence in the country.

Pre-test counseling and post-test counseling shall be done by the HIV and AIDS counselor, licensed social worker, licensed
health service provider for free.
Section 32. HIV Testing for Pregnant Women. - A health care provider who offers pre-natal medical care shall offer provider-
initiated HIV testing for pregnant women. The DOH shall provide the necessary guidelines for healthcare providers in the
conduct of the screening procedure.

ARTICLE V
HEALTH AND SUPPORT SERVICES

Section 33. Treatment of Persons Living with HIV and AIDS. - The DOH shall establish a program that will provide free and
accessible ART and medication for opportunistic infections to all PLHIVs who are enrolled in the program. It shall likewise
designate public and private hospitals to become treatment s hubs. A manual of procedures for management of PLHIV
shall be developed by the DOH.

Section 34. Access to Medical Services by Indigents. - Indigent persons living with HIV shall not be deprived
of access to medical services. The DOH and DSWD shall establish a program that will support better access to ART and
medication for opportunistic infections to all indigent PLHIV, which includes financial support for necessary medical
services related to the person's HIV condition.

Section 35. Economic Empowerment and Support. - PLHIV shall not be deprives of any employment, livelihood, micro-
finance, self-help, and cooperative programs by reason of their HIV status. The DSWD, in coordination with the DILG, DOLE,
and TESDA, shall develop enabling policies and guidelines to ensure economic empowerment and independence designed
for PLHIV.

Section 36. Care and Support for Persons Living with HIV. - The DSWD, in coordination with the DOH, shall develop care and
support programs for PLHIV, which shall include peer-led counseling and support, social
protection, welfare assistance, and mechanisms for case management. These programs shall include care and support for the
affected children, families, partners, and support groups of PLHIV.

Section 37. Care and Support for Overseas Workers Living with HIV. - The Overseas Workers Welfare Administration (OWWA),
in coordination with the DOH, DSWD, DFA, CFO, and the Bureau of Quarantine and International Health Surveillance, shall
develop a program to provide a stigma-free comprehensive reintegration, care, and support program, including economic,
social, medical support for overseas workers, regardless of employment status and stage in the migration process.

Section 38. Care and Support for Affected Families, Intimate Partners, Significant Others and Children of People Living with
HIV. - The DSWD, DOH, and LGUs, in consultation with CSOs and affected families of PLHIV shall develop care and support
programs for affected families, intimate partners, significant others, and children of PLHIV, which shall include the
following:
(a) Education programs that reduce HIV-related stigma, including counseling to prevent HIV-related
discrimination within the family;
(b) Educational assistance for children infected with HIV and children orphaned by HIV and AIDS; and
(c) HIV treatment and management of opportunistic infections for minors living HIV who are not eligible under
the Outpatient HIV and AIDS Treatment (OHAT) Package of the Philippine Health Insurance Corporation
(PhilHealth).

Section 39. Care and Support Program in Prisons and Others Closed-Setting Institutions. - All prisons, rehabilitation
centers, and other closed-setting institutions shall have comprehensive STI, HIV and AIDS prevention and control program
that includes HIV education and information, HIV counseling and testing, and access to HIV treatment and care services.
The DOH, in coordination with DILG, DOJ, and DSWD, shall develop HIV and AIDS comprehensive programs and policies,
which include the HIV counseling and testing procedures in prisons, rehabilitation centers, and other closed-setting
institutions.

PLHIV in prisons, rehabilitation centers, and other closed settings institutions shall be provided HIV treatment, which
includes anti-retroviral drugs, care, and support in accordance with the national guidelines. Efforts should be undertaken to
ensure the continuity of care at all stages, from admission or imprisonment to release. The provision on informed consent
and confidentiality shall also apply in closed-setting institutions.

Section 40. Non-discriminatory HIV and AIDS Services. - The members of the PNAC, in cooperation with the CSOs, and in
collaboration with DOJ and CHR, shall ensure the delivery of non-discriminatory HIV and AIDS services by government and
private HIV and AIDS service providers.

Section 41. Protection of HIV Educators, Licensed Social Workers, Health Workers, and Other HIV and AIDS Service Providers
from Harassment. - Any person involved in the provision of HIV and AIDS services, including peer educators, shall be
protected from suit, arrest or prosecution, and from civil, criminal or administrative liability, on the basis of their delivery of
such services in HIV prevention. This protection does not cover acts which are committed in violated of this Act.

Section 42. Health Insurance and Similar Health Services. - The PhilHealth shall:
(a) Develop a benefit package for PLHIV that shall include coverage for in-patient and out-patient medical and
diagnostic service, including medication and treatment;

(b) Develop a benefit package for the unborn and the newborn child from infected mothers;

(c) Set a preference price for HIV services in government hospitals;

(d) Conduct programs to educate the human resource units of companies on the PhilHealth package on HIV and
AIDS; and

(e) Develop a mechanism for orphans living with HIV to access HIV benefit package.

The PhilHealth shall enforce confidentiality in the provision of these packages to PLHIV. No PLHIV shall be denied or
deprived of private health insurance under a Health Maintenance Organization (HMO) and private life insurance coverage
under a life insurance company on the basis of the person's HIV status. Furthermore, no person shall be denied of his
insurance claims if he dies of HIV or AIDS under a valid and subsisting life insurance policy.

The insurance Commission (IC) shall implement this provision and shall develop the necessary policies to ensure
compliance.

Section 43. HIV and AIDS Monitoring and Evaluation. - The DOH shall maintain a comprehensive HIV and AIDS monitoring
and evaluation program that shall serve the following purposes:

(a) Determine and monitor the magnitude and progression of HIV and AIDS in the Philippines to help the national
government evaluate the adequacy and efficacy of HIV prevention and treatment programs being employed;

(b) Receive, collate, process, and evaluate all HIV and AIDS-related medical reports from all hospitals, clinics,
laboratories and testing centers, including HIV-related deaths and relevant data from public
 and private hospitals, various databanks or information systems: Provided, that it shall adopt a coding system that
ensures anonymity and confidentiality; and

(c) Submit, through its Secretariat, an annual report to the PNAC containing the findings of its monitoring and
evaluation activities in compliance with this mandate.

ARTICLE VI
CONFIDENTIALI
TY

Section 44. Confidentiality. - The confidentiality and privacy of any individual who has been tested for HIV, has been exposed
to HIV, has HIV infection or HIV- and AIDS-related illnesses, or was treated for HIV-related illnesses shall be guaranteed.
The following acts violate confidentiality and privacy:

(a) Disclosure of Confidential HIV ad AIDS Information. - Unless otherwise provided in Section 45 of this Act, it
shall be unlawful to disclose, without written consent, information that a person has AIDS, has undergone HIV-
related test, has HIV infection or HIV-related illnesses, or has been exposed to HIV.

The prohibition shall apply to any person, natural or juridical, whose work or function involves the
implementation of this Act, or the delivery of HIV-related services, including those who handle or have access to
personal data or information in the workplace, and who, pursuant to the receipt of the required written consent
from the subject of confidential HIV and AIDS information, have subsequently been granted access to the same
confidential information.

(b) Media Disclosure. - It shall be unlawful for any editor, publisher, reporter or columnist, in case of printed
materials, or any announcer or producer in case of television and radio broadcasting, or any producer pr
director of films in case of the movie industry, or any other individual or organization in case of social media, to
disclose the name, picture, or any information that would reasonably identify persons living with HIV and AIDS,
or any confidential HIV and AIDS information, without the prior written consent of their subjects except when
the persons waive said confidentiality through their own acts and omissions under Section 4(a) of Republic Act
No. 10175, Otherwise known as the "Cybercrime Prevention Act of 2012" and Section 25 of Republic Act No.
10173, "Data Privacy Act of 2012".

Section 45. Exceptions. - Confidential HIV and AIDS information may be released by HIV testing facilities without consent in
the following instances:

(a) When complying with reportorial requirements of the national active passive surveillance system of the DOH:
Provided, That the information related to a person's identify shall remain confidential;

(b) When informing other health workers directly involved in the treatment or care of a
PLHIV: Provided, that such worker shall be required to perform the duty of shared medical
confidentiality; and

(c) When responding to a subpoena duces tecum and subpoena ad testificandum issued by a court with jurisdiction
over a legal proceeding where the main issue is the HIV status of an
individual: Provided, That the confidential medical record, after having been verified for accuracy by the head of
the office or department, shall remain anonymous and unlinked and shall be properly
 sealed by its lawful custodian, hand delivered to the court, and personally opened by the judge:
Provided, further, That the judicial proceedings be held in executive session.

Section 46. Disclosure of HIV-Related Test Results. - The result of any test related to HIV shall be disclosed by the trained
service provider who conducts pre-test and post-test counseling only to the individual who submitted to the test. If the
patient is below fifteen (15) years old, an orphan, or is mentally incapacitated, 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"
Provided, That when a person below fifteen(15) years of age and not suffering from any mental incapacity, has given
voluntary and informed consent to the procedure in accordance with Section 29(b) of this Act, the result of the test shall be
disclose to child: Provided, further, That the child should be given age-appropriate counseling and access to necessary
health care and sufficient support services.

It may also de disclose to a person authorized to receive such results in conjunction with the DOH Monitoring Body as
provided in Section 43 of this Act.

Section 47. Disclosure to Persons with Potential Exposure to HIV. - Any person who, after having been tested, is found to be
infected with HIV is strongly encouraged to disclose this health condition to the spouse, sexual partners, and/or any person
prior to engaging in penetrative sex or any potential exposure to HIV. A person living with HIV may seek help from qualified
professionals including medical professionals health workers, peer educators, or social workers to support him in disclosing
this health condition to one's partner or spouse.
Confidentiality shall likewise be observed. Further the DOH, through the PNAC, shall establish an enabling environment to
encourage newly tested HIV positive individuals to disclose their status to partners.

Section 48. Duty of Employers, Heads of Government Offices, Heads of Public and Private Schools or Training Institutions,
and Local Chief Executives. - It shall be the duty of private schools and training
institutions, and local chief executives over all private establishments within their territorial jurisdiction, to
prevent or deter acts of discrimination against PLHIV, and to provide procedures for the resolution, settlement, or
prosecution of acts of discrimination against PLHIV, and to provide procedures for the resolution, settlement, or prosecution
of acts of discrimination. Towards this end, the private employer, head of office, or local chief executive shall:

(a) Promulgate rules and regulations prescribing the procedure for the investigation of discrimination cases and the
administrative sanctions thereof; and

(b) Create an ad hoc committee on the investigation of discrimination cases,

The committee shall conduct meetings to increase the members' knowledge and understanding of HIV and AIDS, and to
prevent incidents of discrimination. It shall also conduct the administrative investigation of alleged cases of discrimination.

ARTICLE VII
DISCRIMINATORY ACTS AND PRACTICES AND CORRESPONDING PENALTIES

Section 49. Discriminatory Acts and Practices. - The following discriminatory acts and practices shall be prohibited:
 (a) Discrimination in the Workplace. - The rejection of job application, termination of employment, or other
discriminatory policies in hiring, provision of employment and other related benefit, promotion or assignment of
an individual solely or partially on the basis of actual, perceived, or suspected HIV status;

(b) Discrimination in Learning Institution. - Refusal of admission, expulsion, segregation, imposition of harsher
disciplinary actions, or denial of benefits or services of student or a prospective student solely or partially on the
basis of actual, perceived, or suspected HIV status;
(c) Restriction on Travel and Habitation. - Restrictions on travel within the Philippines, refusal of lawful entry to
Philippine territory, deportation from Philippines, or the quarantine or enforced isolation of travelers solely or
partially on account of actual, perceived, or suspected HIV status is discriminatory. The same standard of
protection shall be accorded to migrants, visitors, and residents who are not Filipino citizens;

(d) Restrictions on Shelter. - Restrictions on housing or lodging, whether permanent or temporary, solely or partially on
the basis of actual, perceived, or suspected HIV status;

(e) Prohibition from Seeking or Holding Public Office. - Prohibition on the right to seek an elective or appointive
public office solely or partially on the basis of actual, perceived, or suspected HIV status;

(f) Exclusion from Credit and Insurance Services. - Exclusion from health, accident or life insurance, or credit and
loan services, including the extension of such loan or insurance facilities, of an individual solely or partially on
the basis of actual, perceived, or suspected HIV status: Provided, That the PLHIV has not concealed or
misrepresented the fact to the insurance company or loan or credit service provider upon application;

(g) Discrimination in Hospitals and Health Institutions. - Denial of health services, or being charges with a higher
fee, on the basis of actual, perceived or suspected HIV status is discriminatory act and is prohibited;

(h) Denial of Burial Services. Denial of embalming and burial services for a decease person who had HIV and AIDS
or who was known, suspected, or perceived to be HIV-positive;

(i) Act of Bullying. - Bullying in all forms, including name-calling, upon a person based on actual, perceived, or
suspected HIV status, including bullying in social media and other online portals; and

(j) Other similar or analogous discriminatory acts.

Section 50. Penalties. –

(a) Any person who commits the prohibited act under Section 22 of this Act on misinformation on HIV and AIDS
shall, upon conviction, suffer the penalty of imprisonment ranging from one (1) year but not more than ten (10)
years a fine of not less than Fifty thousand pesos (50,000.00) but not more than Five hundred thousand pesos
(P500,000.00), or both, at the discretion if the court: Provided, That if the
offender is a manufacturer, importer or distributor of any drugs, devices, agents, and other health products found
in violation of Section 21 of this Act may be seized and held in custody when the FDA Director-General has
reasonable cause to believe facts found by him/her or an authorized officer or employee of the FDA that such
health products may cause injury or prejudice to the consuming public;
(b) Any person who violates the second sentence of Section 24 of this Act on police operations vis-à- vis
comprehensive health intervention for key populations shall upon conviction, suffer the penalty of
imprisonment of one (1) year to five (5) years, and a fine of not less than One hundred thousand pesos (P100,000.00),
but not more than Five hundred thousand pesos (P500,000.00): Provided, That the law enforcement agents found
guilty shall be removed from public service;

(c) Any person who knowingly or negligently causes another to get infected with HIV in the course of the practice
of profession through unsafe and unsanitary practice and procedure, or who compelled any person to undergo
HIV testing without his or her consent shall, upon conviction, suffer the penalty of imprisonment of six (6) to
twelve (12) years, without prejudice to the imposition of fines and
administrative sanctions, such as suspension or revocation of professional licenses;

The permit or license of the business entity and the accreditation of the HIV testing centers may be cancelled or
withdrawn if these establishments fail to maintain safe practices and procedures as may be required by the
guidelines formulated in compliance with Section 26, on blood, tissue, or organ donations, and Section 28, on
medical management, surgical, and other related procedures;

(d) Any person who violates Section 41 of this Act, on the protection of HIV and AIDS service providers from
harassment shall, upon conviction, suffer the penalty of imprisonment of six (6) months to five (5) years, and a
fine of not less than One hundred thousand pesos (P100,000.00), but not less than Five hundred thousand pesos
(P500,000.00): Provided, That if the person who violates this provision is a law enforcement agent or a public
official, administrative sanctions may be imposed in addition to imprisonment and/or fine, at the discretion of
the court;

(e) Any person, natural or juridical, who violates the provisions of Section 42 of this Act on health insurance and similar
services shall, upon conviction, suffer the penalty of imprisonment of six (6)months to five
(5) years, and/or a fine of not less than Fifty thousand (P50,000.00), at the discretion of the court, and without
prejudice to the imposition of administrative sanctions such as fines, suspensions or revocation of business permit,
business license or accreditation, and professional license;

(f) Any person who violates the provisions of Section 44 of this Act on confidentiality shall, upon
conviction, suffer the following penalties:

(1) Six months to two (2) years of imprisonment for any person who breaches confidentiality, and/or a fine of
not less than fifty thousand pesos (P50,000.00), but not more than One hundred fifty thousand pesos
(P150,000.00), at the discretion of the court;

(2) Two years and one (1) day to five (5) years of imprisonment for any person who causes the mass
dissemination of the HIV status of a person, including spreading the information online or making
statements to the media, and/or a fine of not less than One hundred fifty thousand pesos (P150,000.00),
but not more than Three hundred fifty thousand pesos (P350,000.00), at the discretion of the court; and

(3) Five years and one (1) day to seven (7) years of imprisonment for any health professional, medical
instructor, worker, employer, recruitment agency, insurance company, data encoder, and other custodian
of any medical record, file, data, or test result who breaches confidentiality, and/or a fine of not less than
Three hundred fifty thousand pesos (P350,000.00), but not more than Five hundred thousand pesos
(P500,000.00), at the discretion of the court.
These penalties are without prejudice to any administrative sanction or civil suit that may be bought against
persons who violate confidentiality under this Act.
 (g) Any person who shall violate any of the provisions in Section 49 on discriminatory acts and practices shall, upon
conviction, suffer the penalty of imprisonment of six (6) months to five (5) years, and/or a fine of not less than
Fifty thousand pesos (P50,000.00), but not more than Five hundred thousand (P500,000.00), at the discretion of
the court, and without prejudice to the imposition of administrative sanctions such as fines, suspension or
revocation of business permit, business license or accreditation, and professional license; and

(h) Any person who has obtained knowledge of confidential HIV and AIDS information and uses such information to
malign or cause damage injury, or loss to another person shall face liability under Articles 19, 20, 21 and 26 of the
new Civil Code of the Philippines and relevant provisions of Republic Act No. 10173, otherwise known as the "Data
Privacy Act of 2012".

If the offender is a corporation, association, partnership or any other juridical persons, the penalty of imprisonment shall
be imposed upon the responsible officers and employees, as the case may be, who participated in, or allowed by their gross
negligence, the commission on the crime, and a fine shall be imposed jointly and severally on the juridical person and the
responsible officers and/or employees. Furthermore, the court may suspend or revoke its license or business permit.

If the offender is an alien, he/she shall, in addition to the penalties prescribed herein, be deported without further
proceedings after serving penalties herein prescribed.

If the offender is a public official or employee, he/she shall, in addition to the penalties herein, suffer perpetual or
temporary absolute disqualification from office, as the case may be.

Section 51. Penalties Collected. - The penalties collected pursuant to this section shall be put into a special fund to be
administered by the PNAC and shall be use for initial interventions required to address gaps in the national response on
the part of government agencies and its partners from civil society and international organizations in accordance with
Section 5(l) of this Act.

ARTICLE
VIII FINAL
PROVISIONS

Section 52. Appropriations. The amount needed for the initial implementation of this Act shall be charged against the
appropriations for the DOH.1âwphi1 Thereafter, such sums as may be necessary for the continued implementation of this
Act shall be included in the annual General Appropriations Act.

The DBM, in coordination with the Department of Finance (DOF) and the DOH, and other relevant government agencies, shall
consider the incidence of HIV and AIDS, in determining the annual appropriations for the
implementation of thus Act in accordance with the AMTP. A separate budget item in the annual appropriations of the LGUs
shall be allocated for their action plans specified in this Act.

The funding requirement needed to provide for the health insurance package and other services for the PLHIV as stated in
Section 42 hereof shall be charged against the PhilHealth's corporate funds.
The funding needed to upgrade or construct government administered HIV testing and treatment centers shall be funded
from the revenues of the sin tax under Republic Act No. 8424, otherwise known as the "National Internal Revenue Code", as
amended by Republic Act No. 10351 and shall be prioritized under the Health Facilities Enhancement Programs of the
DOH.

The funds to be appropriated for the operations of the PNAC shall be a distinct and separate budget item from the regular
appropriations for the DOH, and shall be administered by the Secretary of Health. In no circumstances shall the
appropriations, savings, and other resources of the PNAC be realigned to the programs and projects of the DOH or any
other government agency, unless such program ir projects is related to the implementation of the provisions under this Act.

Section 53. Transitory Provision. - The personnel designated by the DOH as Secretariat of the PNAC under Section 7 of this
Act shall be absorbed as permanent personnel to fil the positions of the Secretariat as provided in this Act.

Section 54. Implementing Rules and Regulations. The PNAC within ninety (90) days from the effectivity of this Act shall
promulgate the necessary implementing rules and regulations for the effective implementation of this provisions of this
Act.

Section 55. Repealing Clause. - Republic Act No. 8504, otherwise known as the "Philippine AIDS Prevention and Control Act
of 1998", is hereby repealed.

All decrees, executive orders, proclamations, and administrative regulations or parts thereof, particularly in Act No. 3815,
otherwise known as the "Revised Penal Code", as amended, Republic Act No. 8353, otherwise known as the "Anti-Rape Law
of 1997", Executive Order No. 209, otherwise known as the "Family Code of the Philippines", Republic Act No. 7719,
otherwise known as the National Blood Services Act of 1994", and Republic Act No. 7170, otherwise known as the "Organ
Donation Act of 1991", inconsistent with the provisions of this Act are hereby repealed, amended or modified accordingly.

Section 56. Separability Clause. - If any provision or part of this Act declared unconstitutional, the remaining parts or
provisions not affected shall remain in full force and effect.

Section 57. Effectivity. - This Act shall take effect fifteen (15) days after its complete publication in the Official Gazette or in a
newspaper of general circulation.
THE “COMPREHENSIVE DANGEROUS DRUG ACT OF 2002”
• Republic Act No. 9165
• An act instituting the comprehensive dangerous drugs act of 2002, repealing R.A. No. 6425, otherwise known as
the “Dangerous Drugs Act of 1972”, as amended, providing funds therefor, and for other purposes
• Approved – June 7, 2002
• A special penal law that consists of 102 sections

ARTICLE III
DANGEROUS DRUGS TEST AND RECORD REQUIREMENTS

SEC. 36. Authorized Drug Testing. — Authorized drug testing shall be done by any government forensic laboratories or by any of
the drug testing laboratories accredited and monitored by the DOH to safeguard the
quality of test results. The DOH shall take steps in setting the price of the drug test with DOH accredited drug testing centers to
further reduce the cost of such drug test. The drug testing shall employ, among others, two
(2) testing methods, the screening test which will determine the positive result as well as the type of the drug used and the
confirmatory test which will confirm a positive screening test. Drug test certificates issued by accredited drug testing
centers shall be valid for a one-year period from the date of issue which may be used for other purposes. The following
shall be subjected to undergo drug testing:

(a) Applicants for driver’s license. — No driver’s license shall be issued or renewed to any person unless he/she
presents a certification that he/she has undergone a mandatory drug test and indicating thereon that he/she is
free from the use of dangerous drugs;
• No longer required under R.A. No. 10586, otherwise known as the “Anti-Drunk and Drugged Driving
Act of 2013”
• Only drivers in vehicular accidents and persons believed to be driving under the influence of alcohol,
dangerous drug and/or other similar substances by apparent indications and manifestations will be
subjected to a mandatory drug test as well as an alcohol test.

(b) Applicants for firearm’s license and for permit to carry firearms outside of residence. — All applicants for firearm’s
license and permit to carry firearms outside of residence shall undergo a mandatory drug test to ensure that they
are free from the use of dangerous drugs: Provided, that all persons who by the nature of their profession carry
firearms shall undergo drug testing;

(c) Students of secondary and tertiary schools. — Students of secondary and tertiary schools shall, pursuant to the
related rules and regulations as contained in the school’s student handbook and with notice to the parents,
undergo a random drug testing: Provided, that all drug testing expenses whether in public or private schools
under this Section will be borne by the government;

(d) Officers and employees of public and private offices. — Officers and employees of public and private offices,
whether domestic or overseas, shall be subjected to undergo a random drug test as contained in the company’s
work rules and regulations, which shall be borne by the employer, for purposes of reducing the risk in the
workplace. Any officer or employee found positive for use of dangerous drugs
shall be dealt with administratively which shall be a ground for suspension or termination, subject to the provisions of
Article 282 of the Labor Code and pertinent provisions of the Civil Service Law;
 (e) Officers and members of the military, police and other law enforcement agencies. — Officers and members
of the military, police and other law enforcement agencies shall undergo an annual mandatory drug test;

(f) All persons charged before the prosecutor’s office with a criminal offense having an imposable penalty of
imprisonment of not less than six (6) years and one (1) day shall have to undergo a mandatory drug test; and

(g) All candidates for public office whether appointed or elected both in the national or local government shall
undergo a mandatory drug test.

(a) In addition to the above stated penalties in this Section, those found to be positive for dangerous drugs use shall
be subject to the provisions of Section 15 of this Act.

SEC. 37. Issuance of False or Fraudulent Drug Test Results. — Any person authorized, licensed or accredited under this Act
and its implementing rules to conduct drug examination or test, who issues false or fraudulent drug test results knowingly,
willfully or through gross negligence, shall suffer the penalty of imprisonment ranging from six (6) years and one (1) day to
twelve (12) years and a fine ranging from One hundred thousand pesos (P100,000.00) to Five hundred thousand pesos
(P500,000.00).

An additional penalty shall be imposed through the revocation of the license to practice his/her profession in case of a
practitioner, and the closure of the drug testing center.

SEC. 38. Laboratory Examination or Test on Apprehended/Arrested Offenders. — Subject to Section 15 of this Act, any
person apprehended or arrested for violating the provisions of this Act shall be subjected to screening laboratory
examination or test within twenty-four (24) hours, if the apprehending or arresting officer has reasonable ground to
believe that the person apprehended or arrested, on account of physical signs or symptoms or other visible or outward
manifestation, is under the influence of dangerous drugs. If found to be positive, the results of the screening laboratory
examination or test shall be challenged within fifteen (15) days after receipt of the result through a confirmatory test
conducted in any accredited analytical laboratory
equipment with a gas chromatograph/mass spectrometry equipment or some such modern and accepted method, if
confirmed the same shall be prima facie evidence that such person has used dangerous drugs, which is without prejudice
for the prosecution for other violations of the provisions of this Act: Provided, That a positive screening laboratory test must
be confirmed for it to be valid in a court of law.

SEC. 39. Accreditation of Drug Testing Centers and Physicians. — The DOH shall be tasked to license and accredit drug
testing centers in each province and city in order to assure their capacity, competence, integrity and stability to conduct the
laboratory examinations and tests provided in this Article and appoint such technical and other personnel as may be
necessary for the effective implementation of this provision. The DOH shall also accredit physicians who shall conduct the
drug dependency examination of a drug dependent as well as the aftercare and follow-up program for the said drug
dependent. There shall be a control regulations, licensing and accreditation division under the supervision of the DOH for
this purpose.
For this purpose, the DOH shall establish, operate and maintain drug testing centers in government hospitals, which must
be provided at least with basic technologically advanced equipment and materials, in order to conduct the laboratory
examination and tests herein provided, and appoint such qualified and duly trained technical and other personnel as may
be necessary for the effective implementation of this provision.
DDB BOARD REGULATION NO. 2 SERIES OF 2003
• Implementing Rules and Regulations Governing Accreditation of Drug Testing Laboratories in The
Philippines
• Approved – June 27, 2003
• Amendment:
o Board Regulation No. 8 Series of 2007
▪ Amending Board Regulation No. 2, Series of 2003, entitled “Implementing Rules and
Regulations Governing Accreditation of Drug Testing Laboratories in The Philippines”
▪ Approved – December 11, 2007

Section 1. Scope. - These rules and regulations embodied herein shall apply to all government and private drug testing
laboratories in the Philippines.

Section 2. Authority. - These rules and regulations are issued to implement the provisions of Republic Act 9165:
“Comprehensive Dangerous Drugs Act of 2002” consistent with Executive Order 102 s. 1999: “Redirecting the Functions
and Operations of the Department of Health”.

Section 3. Definition of Terms. -

(a) Accreditation refers to the formal authorization issued by the DOH to an individual, partnership,
corporation or association which has complied with all licensing requirements (input/structural
standards) and accreditation requirements (process standards and outcome/output/impact standards) as
prescribed in the Manual of Operations for Drug Testing Laboratories issued by the DOH.
(b) Act refers to Republic Act No.9165, “The Comprehensive Dangerous Drugs Act of 2002”.
(c) Applicant refers to the owner or head of a laboratory that is applying for the issuance of accreditation.
(d) Applications Service Provider refers to third party entities that manage and distribute software-based services and
solutions to customers across a wide area network from a central data center.
(e) Board refers to the Dangerous Drugs Board created under Section 77, Article IX of R.A. No. 9165.
(f) Bureau refers to the Bureau of Health Facilities and Services of the DOH. It shall exercise the regulatory
function.
(g) Bureau Director refers to the director of the Bureau of Health Facilities and Services.
(h) Chain of Custody refers to procedures to account for each specimen by tracking its handling and
storage from point of collection to final disposal. These procedures require that the applicant’s identity is
confirmed and that a Custody and Control Form is used from time of collection to receipt by the laboratory.
Within the laboratory, appropriate chain of custody records must account for the samples until disposal.
(i) Custody and Control Form refers to the form used to document the procedures from time of collection until receipt
by the laboratory.
(j) CHD refers to the Center for Health Development, which is the DOH Regional Field Office.
(k) Client/Donor refers to the individual from whom a specimen is collected.
(l) Confirmatory Test refers to the analytical procedure to identify and quantify the presence of a specific drug or
metabolite, which is independent of the initial test, and which uses a different technique and chemical principle
from that of the screening test in order to ensure reliability and accuracy.
(m) Cut Off refers to the concentration level set to determine whether the sample is positive or negative for the
presence of a drug.
(n) Dangerous Drugs include those listed in the schedule annexed to the Act and its implementing rules and
regulations.
(o) DOH refers to the Department of Health.
 (p) Laboratory refers to a private or government facility that is capable of testing a specimen to determine the
presence of dangerous drugs therein.
(q) NRL refers to the National Reference Laboratory for Environmental and Occupational Health, Toxicology and
Micronutrient Assay designated by the Secretary of Health. It is a laboratory capable of doing screening and
confirmatory laboratory services, training, and surveillance and external quality assurance program for laboratory
tests. Whenever the drug testing laboratory result is challenged, the NRL shall make the final decision.
(r) Procedure Manual refers to the written document giving detailed steps to be followed when
undertaking a particular task.
(s) Screening Test refers to a test to eliminate negative specimen from further consideration and to identify
the presumptively positive specimen that requires confirmatory testing.
(t) Secretary refers to the Secretary of Health.
(u) Specimen refers to the body fluid that is collected from a person.

Section 4. Classification of Drug Testing Laboratories. – Drug testing laboratories shall be classified according to:
1. Ownership
1.1. Government – operated and maintained partially or wholly by the national, provincial, city or municipal
government, or other political unit, or by any department, division, board or agency thereof.
1.2. Private – privately owned, established and operated with funds through donation, principal,
investment or other means, by any individual, corporation, association or organization.
2. Institutional Character
2.1. Institution-based – 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).
2.2. Freestanding – a laboratory that is located outside the premises of an institution and operates
independently.
3. Service Capability
3.1. Screening Laboratory – a laboratory capable of performing screening tests.
3.2. Confirmatory Laboratory – a laboratory capable of performing qualitative and quantitative
examinations of dangerous drugs from the specimen.

Section 5. Client/Donor of Drug Testing Laboratories. – As enumerated and described in R.A. No. 9165 Article III Section 36
the following persons shall undergo drug testing:
Section 6. Technical Requirements for Accreditation. – The laboratory to be able to secure a DOH certificate of accreditation must
comply with the following technical requirements:

1. Physical Plant

1.1. Screening Laboratory - shall have at least twenty (20) square meters in floor area. The work area must be
ten (10) square meters with exhaust fan, sink and storage cabinet.
1.2. Confirmatory Laboratory - shall have at least sixty (60) square meters in floor area. The clinical work area
must be thirty (30) square meters with exhaust fan, sink, stock room and instrumentation room.

A laboratory of whatever category shall have within its premises an area which can receive or accommodate at
least five (5) prospective client/donors at a given time, hand washing facility, toilet facility, and stall for the orderly
collection of specimens.

A DOH-licensed hospital or non-hospital based Secondary or Tertiary Category Clinical Laboratory, which intends to
put up a Screening Laboratory for Drug Testing, need not provide an additional twenty
(20) square meters to its existing floor area. It shall only designate an area for drug testing within the clinical
laboratory.

2. Headship of the Laboratory

The screening laboratory shall be headed by a licensed physician with certification in Clinical Pathology from the
Philippine Board of Pathology or certification in Clinical Laboratory Management Training conducted by the DOH.

The maximum number of screening laboratories a physician trained in Clinical Laboratory Management can handle
is ten (10), provided that they are physically feasible (within 5-kilometer radius) to supervise.

In cases where the screening drug-testing laboratory is a division, section, or unit of a Clinical Laboratory, it shall
be headed either by a licensed physician, chemist, medical technologist, pharmacist or chemical engineer.

The confirmatory laboratory shall be headed by a licensed physician certified in Clinical Pathology by the Philippine
Board of Pathology with at least two (2) years of active laboratory experience in analytical toxicology or a licensed
chemist with at least a master’s degree in chemistry, Biochemistry or a branch of Chemistry and at least two (2)
years of active laboratory experience in analytical chemistry.

The head of the laboratory shall have training and/or experience in the theory and practice of the procedures
used in laboratories, resulting in his or her thorough understanding of quality control procedures and practices;
the review, interpretation and reporting of test results; the maintenance of chain of custody and proper remedial
actions to be taken in response to test systems being out of control limits or quality control results.

The laboratory head shall have the overall responsibility for the professional, organizational, educational and
administrative activities of the drug testing facility.
 3. Personnel

A laboratory shall have the following technical staff:

3.1. Screening Laboratory - shall have either a full-time licensed chemist, medical technologist,
pharmacist or chemical engineer with appropriate training in screening test procedures for
dangerous drugs. The DOH shall recognize the training program.
3.2. Confirmatory Laboratory - shall have a full-time licensed chemist, who has successfully completed extensive
and appropriate training in chromatography, spectroscopy and either a medical technologist, pharmacist or
chemical engineer with appropriate training in the screening test procedure for dangerous drugs. The DOH
shall recognize the training program. The laboratory staff of Confirmatory Laboratory shall be required to
pass a proficiency test, which is to be established and administered by the NRL.

A laboratory shall have administrative or non-technical personnel who shall have the necessary training and skills
for the tasks assigned to them.

4. Laboratory Equipment

A laboratory shall be required to have the following equipment:

4.1. Screening Laboratory - shall have the necessary equipment or kit for screening tests in addition to the basic
equipment.

4.2. Confirmatory Laboratory - shall have the necessary equipment for screening, qualitative and
quantitative examinations in addition to the basic equipment.

Service Confirmatory Laboratory Screening Laboratory

• Immunoassay equipment or • Immunoassay equipment or
Screening Test • BFAD registered drug-testing kit or • BFAD registered drug-testing kit or
• Thin Layer Chromatography (TLC) • Thin Layer Chromatography (TLC)
• Gas Chromatography-Mass
Spectrometer (GC-MS)
• High Performance Liquid
Confirmatory Examination
Chromatography-Mass
Spectrometer (HPLC-MS)
• or some such modern and accepted
equipment
Basic equipment: Basic equipment:
- Laboratory oven - Refrigerator/freezer
- Analytical balance
- Refrigerator
- Freezer
- Fume hood
- Other necessary equipment based
on the procedure used.
5. Information Technology Requirements

5.1. The laboratory shall maintain a set of information technology (IT) equipment whose specification shall
conform to the minimum requirement set by the DOH as the need arises and after due consultation with the
stakeholders. New IT equipment requirements shall be disseminated through a DOH memorandum circular
which shall be posted in the DOH website.

5.2. The laboratory shall have access to and utilize the Integrated Drug Testing Operations Management
Information System (IDTOMIS), which is the Application Service Provider (ASP) approved and
maintained by the DOH.

5.3. Collected subscription fees for the IT Provider shall be used as follows:

5.3.1. Two-thirds (2/3) or 66.67% of the collected fees shall be used to maintain the IDTOMIS and
shoulder confirmatory test requests of screening drug testing laboratories subject to the guidelines
approved by the Board and the DOH; and

5.3.2. One-third (1/3) or 33.33% of the collected fees shall be used to fund drug abuse prevention and
control programs, projects and activities of the Board, subject to the guidelines approved by the Board.”

6. Records

The laboratory shall maintain a record of all its personnel. These records shall include the resume of training and
experience, certification or license, incident reports (if any) and such other information, which will establish the
competence of the employee.

The laboratory must maintain and make available for an agreed period, documentation of all aspects of the testing
process involved in the generation of a positive result.

The required documentation must include:

1. Training records on all individuals authorized to have access to samples
2. Custody and Control Forms
3. Quality assurance / quality control records
4. All data including calibration curves and any calculations used in determining test results
5. Reports
6. Records of performance testing and computer-generated data

The laboratory will be required to maintain documents for any sample under legal challenge for a further agreed
period.

7. Security

A laboratory shall have security measures to control access to the premises and to ensure that only authorized
personnel handle or have access to specimens or can gain access to laboratory processes or to areas where
records are stored. With the exception of duly authorized representative of the
Bureau, all authorized visitors, maintenance and service personnel shall be escorted at all times while inside the
laboratory. The laboratory shall maintain a record that indicates the date, time of entry and exit and purpose of
entry of non-employees.

8. Chain of Custody
 A laboratory shall use documented chain of custody procedures to maintain control and accountability of
specimens. The date and purpose shall be recorded on an appropriate Custody and Control Form each time a
specimen is handled or transferred and every individual in the chain shall be identified.
Accordingly, authorized collection staff shall be responsible for each specimen in their possession and shall sign
and complete the Custody and Control Forms.

The minimum information required on the Custody and Control Form are the following:
1. Information identifying the specimen
2. Date and time of collection
3. Name of testing laboratory
4. Name and signatures of all individuals who had custody of the sample during the collection process

9. Storage of Laboratory Reports and Specimens

Reports pertaining to specimens shall be kept by the testing laboratory for a minimum period to be determined by
the DOH. Specimens with confirmed positive test results, which are not challenged within fifteen (15) days after
receipt, shall be discarded. A specimen may be kept for a maximum of one
(1) year upon request.

10. Test Levels

The Bureau, until such time that the NRL is established and operational shall require each laboratory to submit its
protocol indicating the initial cut-off levels in screening specimens to determine whether they are negative or for
confirmation of the presence of dangerous drugs. The acceptability of the cut off levels shall depend on the
methods used by the laboratory, its equipment and registered testing kits.

11. Procedure Manual

A laboratory shall have a procedure manual validated by the NRL which shall include the principles of each test,
the preparation of reagents, standards and controls, calibration procedures, derivation of results, linearity of
methods, sensitivity of the methods, cut-off values, mechanisms for reporting results, control criteria for
unacceptable specimens and results, remedial actions to be taken when the test
systems are outside of acceptable limits, reagent expiration dates, references and quality control measures. Copies
of all procedures and dates on which they are in effect shall be maintained as part of the manual.

12. Equipment and Instruments

Volumetric pipettes and measuring devices shall be certified for accuracy or be checked by gravimetric, colorimetric
or other verification procedures by the Department of Science and Technology- Industrial Technology Development
Institute. Automatic pipettes and dilutors shall be checked for accuracy and reproducibility before being placed in
service and checked periodically. Thereafter, there shall be written procedures for instruments set-up and normal
operations, a schedule for checking critical operating characteristics, tolerance limits for acceptable function
checks, and instructions for major troubleshooting and repair. Preventive maintenance records shall be kept.

13. Calibrators and Controls

Laboratory calibrators and controls shall be prepared using pure drug reference materials, stock
standard solutions obtained from other laboratories, or standard solutions obtained from commercial
manufacturers. The calibrators and controls shall be properly labeled as to content and concentration. The
 standards (e.g. pure reference standards, stock standard solutions, purchased standards) shall be labeled with the
following: date received (if applicable); date prepared or opened; date placed in service and expiration date.

14. Urine Specimen Collection, Handling and Disposal

The laboratory shall follow the DOH-prescribed guidelines in the collection, handling and disposal of urine
specimens. Universal precaution shall be observed at all times.

14.1. Clients and analysts shall be required to submit fingerprints for every drug testing transaction
following the IDTOMIS Manual as adopted by the Board.

14.2. Laboratories shall use waterless urinals to prevent dilution and tampering of specimen.

14.3. Confirmatory laboratories shall comply with the procedures prescribed in the Quality Manual for
Confirmatory Drug Testing Laboratories as adopted by the Board.

15. Laboratory Report

15.1. Screening test result form – the test result of an accredited laboratory shall be in the form
prescribed by the DOH.

15.2. Signatory of test result – all test results shall bear the signature of the analyst and head of
laboratory.

15.3. Reporting test results – a screening test result shall be reported as negative or positive. A
confirmatory test shall report the presence or absence and the identity of the drug/metabolite tested
as well as its concentration.

The original copy of the test result form shall be given to the client/donor immediately upon its completion. All
specimens with positive screening test results shall be submitted for confirmation before a final report will be
issued. Other copies of the said test result form shall be furnished immediately to the DOH and the requesting
agency. The drug-testing laboratory shall retain one copy.

The test results that are forwarded to the DOH shall include the membrane of the registered drug testing kit in
the case of screening tests and a copy of the chromatogram in the case of confirmatory tests.
15.4. Access to laboratory test results – the drug test result and the records shall be confidential subject
to the usual accepted practices to protect the confidentiality of the test results.
 16. Proficiency Testing

16.1. The NRL shall conduct a continuing assessment of the proficiency of Screening and Confirmatory
Laboratories. All procedures associated with the handling and testing of the proficiency-testing
sample shall to the greatest extent possible be carried out in a manner identical to that applied to
routine specimens, unless otherwise specified.

16.2. Results of proficiency test. The laboratory shall submit to the NRL the results of the test performed on
the unknown sample within three (3) weeks after the receipt of the test sample. Said results shall be
kept confidential.

16.3. Failure to pass proficiency test. A laboratory that fails to pass proficiency test conducted by the NRL shall
be given another test not earlier than one (1) month after the failed test. However, failure to pass
proficiency test shall result in the suspension of its accreditation. Such suspension shall be lifted only after
passing the second proficiency test. Failure to pass the second
proficiency test shall result in the revocation of its accreditation.

Section 7. Validity of the Test Result. –

The drug test certificates on tests performed by accredited drug testing centers shall be valid for one (1) year period
from the date of issue, which may be used for other purposes.

Section 8. Allowable Service Fees. –

The drug-testing laboratory may collect a reasonable service fee for the performed examination, which shall not be
greater than the maximum allowable service fee prescribed by the DOH. The maximum allowable service fees shall be
adjusted from time to time.

Section 9. Procedural Guidelines for Accreditation. –

1. The applicant shall submit the following documents before an initial certificate of accreditation shall be issued:

1.1. DOH Prescribed Application Form - filed either at the Bureau or CHD
1.2. DTI/SEC Registration (for private laboratory) or Enabling Act (for national government laboratory) or
Approved Board Resolution (for local government laboratory)
1.3. One (1) set of Floor Plan showing specific location of equipment and work areas required, appropriately
dimensioned, properly identified and completely labeled, and signed and sealed by an architect or engineer
1.4. List of Personnel, notarized, including xerox copies of current PRC identification cards and
certificates of training
1.5. List of Equipment with specifications
1.6. Contract of Lease (if facility is rented)
1.7. Procedure Manual
1.8. Chain of Custody Form
1.9. Facility Tax Identification Number
 2. The following requirements shall be submitted within the first six (6) months of operation after issuance of the
initial certificate of accreditation:

2.1. Documentation of Quality Control Program (for screening laboratory)

2.2. Certification for Quality Standard System from a DOH recognized certifying body (for confirmatory
laboratory)

3. The applicant shall observe the following procedures for application for initial certificate of accreditation:

3.1. The applicant requests for relevant information and prescribed form from the Bureau or CHD under whose
jurisdiction the proposed laboratory is located either in person or through mail, e-mail or internet.
3.2. The applicant accomplishes required documents and submits them to the Bureau or CHD. Upon filing of
application, the applicant pays the corresponding fees to the Cashier of the Bureau or CHD either in person,
through postal money order or directly to the accredited collecting bank of the DOH.
3.3. The Bureau or CHD conducts survey on site to determine compliance with standards and technical
requirements of accreditation.
3.4. The Bureau approves or disapproves the issuance of certificate of accreditation.

3.4.1. If approved, the Bureau registers the laboratory and issues an initial certificate of accreditation to
the applicant upon deposit of twenty thousand pesos (P20, 000) cash bond.
3.4.2. If disapproved, the Bureau sends the findings and recommendations to the applicant for
compliance.

3.5. If the laboratory has not been approved for accreditation, it may submit an appeal to the Secretary of Health
or designated authority within fifteen (15) days from the receipt of the official denial of application.

4. Hospital-based laboratories shall be licensed as part of the hospital through the One-Stop-Shop Licensure
for Hospitals and are not required to obtain a separate accreditation.

Section 10. Accreditation Fees:

1. The following schedule of fees for initial and renewal of accreditation shall be paid to the Cashier of the DOH.
Accreditation Fees
1.1. Confirmatory laboratory Php 10,000.00
1.2. Screening laboratory Php 5,000.00

The initial certificate of accreditation of private drug testing laboratories shall be issued upon deposit of twenty
thousand pesos (P20, 000.00) cash bond per laboratory.

2. The Bureau is authorized to adjust the accreditation fees from time to time.

Section 11. Content of Certificate of Accreditation. –The certificate of accreditation shall state on its face the name of the
owner and head of the laboratory, the classification and validity period. It shall be signed by the Bureau or CHD Director.
Section 12. Validity. –

The certificate of accreditation shall be valid for a period of two (2) years for Confirmatory Laboratory and one
(1) year for a Screening Laboratory.

Section 13. Renewal Certificate of Accreditation. –

1. Application for renewal of accreditation shall be filed ninety (90) days before the expiry date to the Bureau
or CHD under whose jurisdiction the laboratory is located.

2. The applicant shall submit the following documents before a renewal certificate of accreditation shall be issued.

2.1. Notarized: Application for Renewal of Certificate of Accreditation

2.2. List of Personnel
2.3. List of Equipment/Instruments
2.4. Current Certificate of Accreditation
2.5. Documentation of Chain of Custody
2.6. Facility Tax Identification Number
2.7. Current Certification for Quality Standards Systems – For Confirmatory Laboratory (renewed yearly)
2.8. Documentation/contract for confirmation of screened positive specimens
2.9. Currently Proficiency Test Result (renewed yearly)

3. The applicant shall observe the following procedures for renewal of certificate of accreditation:

3.1. The applicant requests for relevant information and prescribed form from the Bureau or CHD under whose
jurisdiction the proposed laboratory is located either in person or through mail, e-mail or internet.

3.2. The applicant accomplishes required documents and submits them to the Bureau or CHD. Upon filing of
application, the applicant pays the corresponding fees for renewal to the Cashier of the Bureau or CHD either
in person, through postal money order or directly to the accredited collecting bank of the DOH.

3.3. The Bureau or CHD conducts a survey to determine compliance with standards/requirements.

3.4. The Bureau approves or disapproves the issuance of certification of accreditation.

3.4.1. If approved, the Bureau renews the certificate of accreditation to the applicant.
3.4.2. If disapproved, the Bureau sends the findings and recommendations to the applicant for
compliance. The applicant requests the Bureau for another survey.

3.5. If a laboratory has not been approved for renewal, it may submit an appeal to the Secretary of Health
or designated authority within fifteen (15) days from the receipt of the official denial of application.
Section 14. Monitoring of Laboratories. –

The Bureau or CHD may conduct an on-site monitoring visit of accredited laboratories. The monitoring visits shall be
conducted unannounced. The monitoring visits shall document the overall quality of the laboratory setting.

Section 15. Terms and Conditions of Accreditation. –

1. An accreditation shall be granted in accordance with prescribed accreditation requirements and on the basis
of specific conditions and limitations established during survey.
2. An accreditation that is not renewed on the expiry date shall be considered lapsed and registration shall be
cancelled. A new application for the issuance of accreditation shall be required before a laboratory can be
allowed to operate.
3. The accreditation as herein granted as well as any right under the accreditation cannot be assigned or
otherwise transferred directly or indirectly to any party.
4. The Bureau shall be notified of any change in management name or ownership. In cases of transfer of
location, a new application for accreditation shall be required.
5. Failure to report in writing within fifteen (15) days of any substantial change in the condition of the
laboratory (e.g. changes in the physical plant, equipment or manpower) may be a basis for the suspension
or revocation of the accreditation.
6. A separate accreditation shall be required for all laboratories or branches maintained in separate premises
but operated under the same management. The accreditation shall be placed in an area readily seen by the
public.
7. A copy of the rules and regulations shall be readily available for guidance of all personnel of the
laboratory.

Section 16. Violations. –

Violations of this Implementing Rules and Regulations shall include among others the commission of the following acts:

1. Issuance of false or fraudulent drug test results.

2. Failure to protect the confidentiality of drug test results.
3. Failure to participate or pass the proficiency testing.
4. Conviction of the owner or manager of a laboratory for any criminal offense committed as an incident to the
operation of the laboratory.
5. Failure to refer the positive screening test results to a Confirmatory Laboratory.
6. Any other cause which materially affects the ability of the laboratory to ensure the full reliability and accuracy
of drug tests and the accurate reporting of results.
7. Failure on the part of the medical facility to submit documentation of Quality Control Program (for screening
laboratory) and certification of Quality Standard System from a DOH-recognized certifying body (for
confirmatory laboratory) within 6 (six) months of operation after issuance of initial certificate of accreditation
will cause revocation of the initial certification of accreditation.
8. Refusal to allow survey, monitoring of a laboratory by the Bureau or CHD at an appropriate time.
9. Any act which is contrary to the accepted clinical laboratory practices.
10. Refusal to perform tests on submitted specimens for screening or confirmation.
11. Failure to follow the prescribed flow of activities described in the IDTOMIS Manual and Quality Manual
for Confirmatory Drug Testing Laboratories as adopted by the Board.
Commission or omission of any of the aforementioned acts shall be a ground for suspension / revocation of
certificate of accreditation without prejudice to the filing of any appropriate criminal action under Section 32 of
R.A. 9165.

Section 17. Suspension or revocation Certificate of Accreditation. –

The Bureau on its own or based on complaint, shall investigate and after due hearings may suspend or revoke the
accreditation of a laboratory for such period and under such terms as may be necessary to ensure the full reliability and
accuracy of drug tests and the accurate reporting of test results. If upon survey or monitoring visits, the drug testing
laboratory is found to be violating the rules and regulations as well as other violations
stipulated under Section 17, the Bureau may immediately preventively suspend the operation of the said laboratory.
Preventive suspension shall not be more than sixty (60) days.

Section 18. Reapplication for Certificate of Accreditation. –

A laboratory whose Certificate of Accreditation has been revoked may reapply for the issuance of a new one upon
compliance with the requirements established hereunder and/or the correction of the deficiency or violation, which
resulted in the revocation.

Section 19. Appeal. –

Any laboratory or any of its personnel aggrieved by the decision of the Bureau may, within fifteen (15) days
after receipt of the notice of decision, file a notice of appeal with the Office of the Secretary, and serve a copy of the notice
of appeal to the Bureau. Thereupon, the Bureau shall promptly certify and file a copy of the decision, including the
transcript of the hearings on which the decision is based with the Office of the Secretary for review and consideration.

Section 20. Penal Provisions. –

Any person authorized or accredited under this Act and its implementing rules to conduct drug examination or test, who
issues false or fraudulent drug test result knowingly, willfully or through gross negligence, shall suffer the penalty of
imprisonment ranging from six (6) years and one (1) day to twelve (12) years and a fine ranging from one hundred
thousand pesos (P100, 000.00) to five hundred thousand pesos (P500, 000.00). Further, revocation of license to practice
shall be recommended to the Professional Regulation Commission.

Section 21. Transitory Provisions. –

Until such time that the NRL for toxicology of the DOH is established and operational, the DDB-Laboratory shall act as the
NRL.

In administrative regions where there are no Gas Chromatography-Mass Spectrometer (GCMS) nor High
Performance Liquid Chromatography-Mass Spectrometer (HPLC-MS) equipment currently available, all DDB licensed drug
testing laboratories using High Performance Liquid Chromatography (HPLC) may be allowed to operate as Confirmatory
Laboratory using such machine provided that its photo diode array is not more than two (2) years. In the absence of GC-MS
and HPLC with photodiode array of not more than two years, licensed drug-testing laboratories using Thin Layer
Chromatography (TLC) may be allowed to perform confirmatory tests.
In the event that a confirmatory laboratory with GC-MS or HPLC-MS is accredited by the DOH in administrative regions where
they were not earlier available, use of HPLC with photo- diode array of not more than two years or TLC shall be allowed only
for a maximum period of ninety (90) days from receipt of notice of such accreditation from the DOH, which notice must be
sent within ten (10) days from approval.

In the event that a confirmatory laboratory with HPLC with photo diode array of not more than two years is accredited by
the DOH in administrative regions where GCMS or HPLC-MS is not available, use of TLC shall be allowed only for a
maximum period of ninety (90) days from receipt of notice of such accreditation from DOH, which notice must be sent
within ten (10) days from approval.

When modern and accepted methods for confirmatory testing emerge, the DOH shall immediately conduct technical studies
and submit recommendations to the DDB for appropriate action.

The use of DDB validated drug testing kits shall be allowed until December 31, 2003. Thereafter, only Bureau of Food and
Drugs registered kits shall be used.

Manual processing of necessary documents shall be done in facilities where an Application Service Provider (ASP) is not
available.

These rules and regulations shall be subject for review annually.

Section 23. Separability. –

In the event that any section, paragraph, sentence, clause or word of this order is declared invalid for whatever, any reason,
other provisions thereof shall not be affected thereby.

Section 24. Effectivity. –

These rules and regulations shall take effect upon approval of the Dangerous Drugs Board and publication in a newspaper of
general circulation.
THE "NEWBORN SCREENING ACT OF 2004”
• Republic Act No. 9288
• An act promulgating a comprehensive policy and a national system for ensuring newborn screening
• Approved – April 7, 2004

ARTICLE 1
GENERAL
PROVISIONS

SEC. 3. Objectives. —The objectives of the National Newborn Screening System are:

1) To ensure that every newborn has access to newborn screening for certain heritable conditions that can result in
mental retardation, serious health complications or death if left undetected and untreated;

2) To establish and integrate a sustainable newborn screening system within the public health delivery system;

3) To ensure that all health practitioners are aware of the advantages of newborn screening and of their respective
responsibilities in offering newborns the opportunity to undergo newborn screening; and

4) To ensure that parents recognize their responsibility in promoting their child's right to health and full
development, within the context of responsible parenthood, by protecting their child from preventable causes of
disability and death through newborn screening.

ARTICLE 2
DEFINITION OF TERMS

SEC. 4. Definitions. —Under this Act, the following terms shall have the meanings respectively given to them below:
1) Comprehensive Newborn Screening System – means a newborn screening system that includes, but is
not limited to, education of relevant stakeholders; collection and biochemical screening of blood
samples taken from newborns; tracking and confirmatory testing to ensure the accuracy of screening
results; clinical evaluation and biochemical/ medical confirmation of test results; drugs and medical/
surgical management and dietary supplementation to address the heritable conditions; and evaluation
activities to assess long term outcome, patient compliance and quality assurance.
2) Follow-up – means the monitoring of a newborn with a heritable condition for the purpose of
ensuring that the newborn patient complies fully with the medicine or dietary prescriptions.
3) Health institutions – mean hospitals, health infirmaries, health centers, lying-in centers or
puericulture centers with obstetrical and pediatric services, whether public or private.
4) Healthcare practitioner – means physicians, nurses, midwives, nursing aides and traditional birth
attendants.
5) Heritable condition – means any condition that can result in mental retardation, physical deformity or
death if left undetected and untreated and which is usually inherited from the genes of either or both
biological parents of the newborn.
6) NIH – means the National Institute of Health.
7) Newborn – means a child from the time of complete delivery to 30 days old.
 8) Newborn Screening – means the process of collecting a few drops of blood from the newborn onto an
appropriate collection card and performing biochemical testing for determining if the newborn has a
heritable condition.
9) Newborn Screening Center – means a facility equipped with a newborn screening laboratory that
complies with the standards established by the NIH and provides all required laboratory tests and
recall/follow-up programs for newborns with heritable conditions.
10) Newborn Screening Reference Center – means the central facility at the NIH that defines testing and
follow-up protocols, maintains an external laboratory proficiency testing program, oversees the national
testing database and case registries, assists in training activities in all aspects of the program, oversees
content of educational materials and acts as the Secretariat of the Advisory Committee on Newborn
Screening.
11) Parent education – means the various means of providing parents or legal guardians
information about newborn screening.
12) Recall – means a procedure for locating a newborn with a possible heritable condition for purposes of
providing the newborn with appropriate laboratory testing to confirm the diagnosis and, as appropriate,
provide treatment.
13) Treatment – means the provision of prompt, appropriate and adequate medicine, medical and surgical
management or dietary prescription to a newborn for purposes of treating or mitigating the adverse
health consequences of the heritable condition.

ARTICLE 3
NEWBORN
SCREENING

SEC. 5. Obligation to Inform. – Any health practitioner who delivers, or assists in the delivery, of a newborn in the Philippines
shall, prior to delivery, inform the parents or legal guardian of the newborn of the availability, nature and benefits of
newborn screening. Appropriate notification and education regarding this obligation shall be the responsibility of the
Department of Health (DOH).

SEC. 6. Performance of Newborn Screening. – Newborn screening shall be performed after twenty-four (24) hours of life but
not later than three (3) days from complete delivery of the newborn. A newborn that must be placed in intensive care in
order to ensure survival may be exempted from the 3-day requirement but must be tested by seven (7) days of age. It shall
be the joint responsibility of the parent(s) and the practitioner or other person delivering the newborn to ensure that
newborn screening is performed. An appropriate informational brochure for parents to assist in fulfilling this responsibility
shall be made available by the Department of Health and shall be distributed to all health institutions and made available to
any health practitioner requesting it for appropriate distribution.

SEC. 7. Refusal to be Tested. – A parent or legal guardian may refuse testing on the grounds of religious beliefs but shall
acknowledge in writing their understanding that refusal for testing places their newborn at risk for undiagnosed heritable
conditions. A copy of this refusal documentation shall be made part of the newborn's medical record and refusal shall be
indicated in the national newborn screening database.

SEC. 8. Continuing Education, Re-education and Training of Health Personnel. – The DOH, with the assistance of the NIH
and other government agencies, professional societies and non-government organizations, shall: (i) conduct continuing
information, education, re education and training programs for
health personnel on the rationale, benefits, procedures of newborn screening; and (ii) disseminate information materials on
newborn screening at least annually to all health personnel involved in maternal and pediatric
care.
SEC. 9. Licensing and Accreditation. – The DOH and the Philippine Health Insurance Corporation (PHIC) shall require health
institutions to provide newborn screening services as a condition for licensure or accreditation.

ARTICLE 4
IMPLEMENTATI
ON

SEC. 10. Lead Agency. — The DOH shall be the lead agency in implementing this Act. For purposes of achieving the
objectives of this Act, the DOH shall:

1) Establish the Advisory Committee on Newborn Screening;

2) Develop the implementing rules and regulations for the immediate implementation of a nationwide newborn
screening program within one hundred eighty (180) days from the enactment of this Act;
3) Coordinate with the Department of the Interior and Local Government (DILG) for implementation of the newborn
screening program;
4) Coordinate with the NIH Newborn Screening Reference Center for the accreditation of Newborn Screening
Centers and preparation of defined testing protocols and quality assurance programs.

SEC. 11. Advisory Committee on Newborn-Screening. – To ensure sustained inter-agency collaboration, the Advisory Committee
on Newborn Screening is hereby created and made an integral part of the Office of the Secretary of the DOH. The Committee
shall review annually and recommend conditions to be included in the newborn screening panel of disorders; review and
recommend the newborn screening fee to be charged by Newborn Screening Centers; review the report of the Newborn
Screening Reference Center on the quality assurance of the Newborn Screening Centers and recommend corrective measures as
deemed necessary.

The Committee shall be composed of eight (8) members, including the:

• Secretary of Health – Chairperson
• Executive Director of the NIH – Vice Chairperson
• Members of the Committee:
o Undersecretary of the DILG
o Executive Director of the Council for the Welfare of Children
o Director of the Newborn Screening Reference Center
o 3 representatives appointed by the Secretary of Health who shall be a pediatrician, obstetrician,
endocrinologist, family physician, nurse or midwife, from either the public or private sector.
▪ appointed for a term of three (3) years, subject to their being reappointed for additional three
(3) year periods for each extension.

The Committee shall meet at least twice a year. The NIH shall serve as the Secretariat of the Committee.

SEC. 12. Establishment and Accreditation of Newborn Screening Centers. – The DOH shall ensure that Newborn Screening
Centers are strategically located in order to be accessible to the relevant public and provide services that comply with the
standards approved by the Committee upon the recommendation of the NIH. No Newborn Screening Center shall be allowed
to operate unless it has been duly accredited by the DOH based on the standards set forth by the Committee.

At a minimum, every Newborn Screening Center shall:

i. have a certified laboratory performing all tests included in the newborn screening program
ii. have a recall/follow up programs for infants found positive of any and all of the heritable conditions
 iii. be supervised and staffed by trained personnel who have been duly qualified by the NIH
iv. submit to periodic announced or unannounced inspections by the Reference Center in order to evaluate
and ensure quality Newborn Screening Center performance.

SEC. 13. Establishment of a Newborn Screening Reference Center. – The NIH shall establish a Newborn Screening Reference
Center, which shall be responsible for the national testing database and case registries, training, technical assistance and
continuing education for laboratory staff in all Newborn Screening Centers.

SEC. 14. Quality Assurance. – The NIH Newborn Screening Reference Center shall be responsible for drafting and ensuring
good laboratory practice standards for newborn screening centers, including establishing an external laboratory proficiency
testing and certification program. It shall also act as the principal repository of technical information relating to newborn
screening standards and practices and shall provide technical
assistance to newborn screening centers needing such assistance.

SEC. 15. Database. – All Newborn Screening Centers shall coordinate with the NIH Newborn Screening Reference Center for
consolidation of patient databases. The NIH Newborn Screening Reference Center shall maintain a national database of
patients tested and a registry for each condition. It shall submit reports annually to the Committee and to the DOH on
status of and relevant health information derived from the database. A plan for long-term outcome evaluation of newborn
screening utilizing the cases registries shall be developed with in one (1) year of passage of this Act by the NIH Newborn
Screening Reference Center in consultation with the Advisory Committee on Newborn Screening. Implementation of this
plan shall become a responsibility of the Advisory Committee on Newborn Screening.

SEC. 16. Newborn Screening Fees. – The PHIC shall include cost of newborn screening in its benefits package. The newborn
screening fee shall be applied to, among others, testing costs, education, sample transport, follow-up and reasonable
overhead expenses.

To ensure sustainability of the National System for Newborn Screening, the newborn screening fee shall be divided and set
aside for the following purposes: at least four percent (4% ) to the DOH's Centers for Health Development or its future
equivalent to be spent solely for follow-up services, education and other activities directly related to the provision of
newborn screening services; at least four percent (4%) to the Newborn Screening Centers for human resource development
and equipment maintenance and upgrading; at least four percent (4%) to the NIH Newborn Screening Reference Center for
overall supervision; training and continuing education, maintenance of national database, quality assurance program and
monitoring of the national program; and the balance for the operational and other expenses of the Newborn Screening
Center.

ADMINISTRATIVE ORDER NO. 2020-0052

• Revised Guidelines on the Implementation of the Expanded Newborn Screening Program
• Repealed A.O. No. 2014-0045 and A.O. No. 2014-0045-A

OBJECTIVE

To update the guidelines on the following:

1. Implementation of the Expanded Newborn Screening Program;
2. Expansion of the National Comprehensive. Newborn Screening System (NCNBSS) with the
establishment of the Centers for Human Genetics Services (CHGS).
3. Allocation and utilization of a portion of the ENBS funds for the operation of the CHGS and for the
management (diagnostic and therapeutic) of patients.
GENERAL GUIDELINES
A. Expanded Newborn Screening shall be offered in all NSFs.
B. The number of disorders in the expanded newborn screening panel shall be twenty-eight (28) and more falling
under various types of disorders namely:
• hemoglobinopathies
• amino acid disorders
• organic acidurias
• disorders of fatty acid oxidation
• disorders of carbohydrate metabolism
• disorders of biotin metabolism
• cystic fibrosis, and
• endocrine disorders
C. The NCNBSS-Treatment Network for the expanded newborn screening shall be maintained in strategic areas of the
country.
a. Confirmatory centers that provide confirmatory testing following a positive screen and follow-up of
diagnosed individuals shall be maintained and the list of confirmatory centers to be provided by NSRC.
Confirmatory Testing Fund allocation, from the NSCs and CHD shares on portion of the ENBS Fee, shall
be used for confirmatory testing of conditions included in the newborn screening panel.
b. The CHGS shall be established and will cover island-wide services (Luzon, Visayas, and Mindanao). It shall
facilitate comprehensive clinical evaluation, appropriate diagnostic and therapeutic management, and
genetic counseling services to families or individuals confirmed to have a disorder included in the ENBS
panel.
c. Newborn Screening Continuity Clinics (NBSCCs) established as per AO No. 2014-0035 shall be added in
strategic areas of the country to facilitate and increase access to long term care of patients confirmed
through newborn screening.
d. Experts’ committees on ENBS panel of disorders shall be created and maintained to provide new
information on the disorders, participate in the review of datasets and cutoffs of the
disorders, propose research agenda and recommend inclusion of new disorders.
D. Information, education, and communication on the expanded screening and the disorders included shall be made
available to health professionals, parents, and the general public at all NSCs, DOH-Central Office, DOH-CHDs, MOH-
BARMM, and Newborn Screening Facilities through multi-media in
collaboration with the DOH-HPCS and NSRC.
E. Newborn Screening Center preparations shall include laboratory renovations to meet accreditation standards,
procurement of equipment and reagents, hiring and training of personnel, upgrading of database,
preparation of manuals and protocols, and implementation of other necessary program
groundwork and shall be undertaken in line with the strategies enumerated in the National Policy and Strategic
Framework on Expanded Newborn Screening for 2017-2030.

SPECIFIC GUIDELINES

A. Establishment of CHGS

1. National Institutes of Health-Institute of Human Genetics (NIH-IHG) shall establish the CHGS of the
Newborn Screening Program.

2. The NIH-IHG shall have administrative and operational oversight of all CHGS.
 3. The NIH-IHG shall serve as the CHGS for Luzon. It shall establish satellite CHGS in Visayas, Mindanao
and other centers in the future.

4. The CHGS shall be manned by a core team composed of clinical geneticist, pediatrician or family
physician, nurse, dietitian/nutritionist, pharmacist, genetic counselors, psychologists, social worker
and administrative staff.

B. Roles and Responsibilities

1. The Department of Health

a. The Department of Health, through the Disease Prevention and Control Bureau- Children’s
Health Development Division (DPCB-CHDD), shall be the lead agency in the implementation of
ENBS. Its roles and responsibilities are stated in Section 13 of the Implementing Rules and
Regulations of RA 9288. The DPCB-CHDD shall also be responsible in reviewing/updating the
guidelines periodically at least 3 years or sooner if there are new developments in the
program.
b. The Health Promotion and Communications Service (HPCS), in coordination with the NSRC,
shall be responsible for advocacy and information dissemination on expanded newborn
screening to the communities throughout the country.
c. The Health Facilities and Services Regulatory Bureau (HFSRB) shall ensure health facilities
applying as newborn screening facilities shall comply to the minimum regulatory standards
set by the DOH in the provision and delivery of quality maternal and newborn care services.
Further, it shall enforce the fines and other penalties as contained in issuances concerning
ENBS fees and the like.
d. The Health Facility Development Bureau (HFDB)shall assist in the identification of facilities or
institutions that will qualify as the Newborn Screening Centers in the other parts of the
country where the services of such will contribute in the provision of the comprehensive
newborn screening services. It shall integrate and update relevant aspects of establishing and
developing NSCs all over the country in the Health Facility Development Plan sensitive to the
needs of the country. Further, the HFDB shall provide technical inputs in the further
development of these NSCs in various joint workshops of the NSRC and DOH.

2. Centers for Health Development shall:

a. Assist in the implementation of expanded newborn screening;
b. Collaborate with relevant stakeholders; and
c. Allocate funds for expenses related to monitoring of patients and adherence to medical
management and continuity care where needed.

3. Philippine Health Insurance Corporation (PhilHealth) shall:

a. Include the full coverage of the ENBS in the PhilHealth Newborn Care Package.
b. Issue circulars defining the new policies and procedures on the enhancement of the
Newborn Care Package, particularly on ENBS.
c. Revise the coverage of the current Newborn Care Package 7 based on the
recommendations from the Health Technology Assessment Council.

4. Newborn Screening Facilities shall:

a. Ensure that expanded newborn screening is offered; and
 b. Provide information, education, communication, screening, recall and management of identified
cases and other related services, as outlined in Section 14 of the IRR of RA 9288.

5. Newborn Screening Reference Center shall:

a. Provide the guidelines for the establishment of the NSCs, NBSCCs, CHGS, and other health
facilities that will be relevant to the implementation of the ENBS Program, to include but not
limited to personnel requirements (for hiring and renewal) and
laboratory accreditation requirements;
b. Define the testing and follow-up protocols for the additional disorders;
c. Maintain an external laboratory proficiency testing program;
d. Integrate the additional disorders in its case registries and national testing database;
e. Assist in training activities in all aspects of the NBS program;
f. Handle the legal requirements for the remittance, allocation, and transfer of fund with NSCs
and with NIH-IHG;
g. Determine the appropriate allocation of funds for confirmatory testing and
management/treatment based on the prevailing costs in coordination with DOH; and
h. Conduct program monitoring in coordination with the Department of Health.

6. NIH-IHG shall:
a. Establish and oversee the operations of CHGS;
b. Facilitate the procurement and distribution of goods needed by the NSCs and the CHGS;
c. Submit to NSRC the annual funding proposal for the procurement and distribution of
specific goods needed and the operations of CHGS; and
d. Submit quarterly reports to NSRC on n procured and required | medicines for CHGS. |
e. Submit consolidated reports of CHGS to NSRC.

7. Centers for Human Genetic Services shall:

a. Facilitate comprehensive clinical management and genetic. - counseling services for families
and individuals;
b. Assist NSCs, NSFs, and NBSCCs in the acute and long-term management of patients;
c. Serve as the central repository of medical foods, orphan drugs and products and other
treatment needs not readily available locally and/or commercially;
d. Coordinate the distribution of medical food, supplies, drugs to NSCs and NBSCCs;
e. Conduct research that shall contribute evidence-based data for directing strategic future
plans of the National Comprehensive Newborn Screening System program;
f. Collaborate with NIH-IHG in developing management guidelines and other related
advocacy materials targeting relevant stakeholders;
g. Submit periodic reports to NIH-IHG. And
h. Assists NSRC in its capacity building among health personnel of NBSCCs, among others;

8. Newborn Screening Centers shall:

a. Ensure that personnel, laboratory space, equipment and. supplies needed for the
implementation of the expanded newborn screening are in place;
b. Ensure that the mechanism for ordering and payment of expanded newborn screening service
is in place;
c. Strictly follow the prescribed guidelines of good laboratory practices;
 d. Establish an appropriate financial and inventory system that shall ensure effective and
efficient distribution of goods to patients with metabolic disorders and acute crisis;
e. Ensure that patients identified positive in any of the disorders are followed up,
confirmed, and referred to specialists for initial management;
f. Remit funds to NSCR for treatment and for CHGS;
g. Allocate funds for monitoring, appropriate diagnostic and therapeutic management, and
confirmatory of patients where necessary;
h. Coordinate with CHGS on the management of patients A. needing further diagnosis and/or
management; and
i. Endorse confirmed patients to the NBSCCsfor continuity care.

9. Newborn Screening Continuity Clinics (NBSCCs) shall:

a. Facilitate continuous care of confirmed positive patients;
b. Provide long-term follow-up care activities related to improving care delivery, including
engagement of affected individuals and their families;
c. Ensure periodic distribution of goods to patients seen at the continuity clinic;
d. Ensure proper storage of goods;
e. Maintain buffer stock and record of goods;
f. Coordinate with the CHGS on provision of long-term management of their patients,
including supply of medical food and orphan drugs/products;
g. Provide monitoring data and surveillance of patients to NSRC and DOH for policy
development;
h. Schedule genetic counseling sessions for the parents and other family members, either
face-to-face or Telegenetic counseling;
i. Submit periodic reports to CHGS on the agreed indicators for quality care of patients;
j. Submit quarterly reports to NSRC.

C. Budget Source

1. The NBS Fee

a. The adjusted ENBS Fee shall be Php1, 750.00 (Per recommendation of the Advisory
Committee on Newborn Screening on October 04,2018).
b. For PhilHealth members the total ENBS Fee of Php1,750.00 shall be covered.
c. ENBS shall have an allowable charge of P50 for the collection of the sample (DOH AO No.
2005-005).
d. Overpricing of newborn screening fees shall be reported to the Department of Health- Health
Facilities and Services Regulatory Bureau (HFSRB. The administrative fines shall be imposed
on health facilities that collect more than the maximum allowable NBS fees (DOH AO 2008-
0026-A):
i. 1st offense – Warning
ii. 2nd offense – Administrative fine of fifty thousand pesos (P50, 000)
iii. 3rd offense – Administrative fine or one hundred thousand pesos (P100,000)

2. Usage of the NBS Fee

a. As stated in Section 22 of the Implementing Rules and Regulations of RA 9288, “Guidelines
on the usage of funds, as approved by the ACNBS, shall be formulated by the NIHP and DOH.
The NBS fee shall be applied to, among others, testing costs, education, sample transport,
follow-up and reasonable overhead expenses.”
 b. The treatment fund is a portion of ENBS fee that shall be allocated to augment the cost of
treatment and management of patients.
c. The NSRC shall prepare a Memorandum of Agreement (MOA) with NSCs and NIH- IHG for the
allocation and transfer of funds from NSC which shall in turn be transferred to IHG for the
procurement of medicines, medications, and medical/surgical management for patients from
all NSCs and the operation of CHGS.
d. NSCs shall allot:
i. P200 per patient screened intended for treatment fund, and facilitate quarterly
transfer of treatment fund to NSRC based on actual collection; and
ii. P30 per patient screened intended for operations of the CHGS and facilitate
quarterly transfer of fund to - NSRC based on actual collection. The budget for the
CHGS operations shall include Personnel Services, Maintenance and Office Operation
Expenses and Capital Outlay (e.g. space rental/renovation,
office equipment, etc.).
e. The Treatment Fund shall augment expenses for treatment of patients with a confirmed
metabolic disorder who underwent ENBS. These expenses shall be limited to medications,
dietary supplements, medical food, and highly specialized medical supplies. The list shall be
provided by the NIH-IHG;
f. The Treatment Fund support shall also be provided for initial (one-time) acute crisis
management. This shall be limited to emergency medical procedures (e.g. peritoneal dialysis,
central line placement), medications, medical food, dietary supplements, and highly
specialized medical supplies. This shall not be convertible to cash;
g. The assistance to patients shall be subject to availability of funds; and
h. All disbursements of funds shall be subject to existing accounting and auditing rules and
regulations.

D. Reporting and Monitoring Protocol

An evaluation plan shall be implemented that would clearly define selected indicators, assign responsibility for
monitoring, and outline the periodicity with which evaluations are to occur. The program evaluation shall
encompass the detailed procedures, operational arrangements, performance evaluation of program implementers,
and fund management.

Operational details of the CHGS operations and Treatment Fund shall be incorporated in the MOA, Department Circulars,
and/or Manual of Operations.

REPEALING/ SEPARABILITY CLAUSE

No. 2014-0045, 2014- 0045-A and other issuances that are inconsistent are hereby repealed/rescinded. If any provision
of this Order is declared invalid, the other provisions not affected thereby shall remain valid and subsisting.
HERITABLE CONDITIONS TESTED UNDER ENBS

Endocrine Disorders - Congenital Hypothyroidism

- Congenital Adrenal Hyperplasia

Amino Acid Disorders - Homocystinuria

- Hypermethioninemia
- Maple syrup urine disease
- Phenylketonuria
- Tyrosinemia I
- Tyrosinemia II
- Tyrosinemia III

Fatty Acid Disorder - Carnitine Palmitoyltransferase I Deficiency

- Carnitine Palmitoyltransferase II Deficiency
- Carnitine Uptake Deficiency
- Glutaric Acidemia type II
- Long chain hydroxyacyl-CoA dehydrogenase deficiency
- Medium chain-Acyl-CoA dehydrogenase deficiency
- Very long chain-Acyl-CoA dehydrogenase deficiency
- Tri-functional protein deficiency

Organic Acid Disorders - 3-methylcrotnyl CoA carboxylase deficiency

- Beta ketothiolase deficiency
- Glutaric acidemia type I
- Isovaleric acidemia
- Methylmalonic acidemia
- Multiple carboxylase deficiency
- Propionic acidemia

Urea Cycle Defects - Citrullinemia

- Argininosuccinic aciduria

Hemoglobinopathies - Alpha thalassemia

- Beta thalassemia
- Hemoglobin C
- Hemoglobin D
- Hemoglobin E
- Sickle Cell Disease

Others - Galactosemia
- Glucose-6-phosphate dehydrogenase deficiency
- Cystic fibrosis
- Biotinidase deficiency
LAWS GOVERNING WATER ANALYSIS LABORATORIES
• Presidential Decree No. 856
o “Code on Sanitation of the Philippines”
o Approved – December 23, 1975

CHAPTER II – WATER SUPPLY

SEC. 9. Prescribed Standards and Procedures – Standards for drinking water and their bacteriological and chemical
examinations, together with the evaluation of results, shall conform to the criteria set by the National Drinking Water
Standards. The treatment of water to render it safe for drinking, and the disinfection of contaminated water sources
together with their distribution systems shall be in accordance with procedures prescribed by the Department.

SEC. 10. Jurisdiction of the Department – The approval of the Secretary or that of his duly authorized representative is required
in the following cases:

a. Sites of water sources before their construction;

b. Delivery of water to consumers from new or recently repaired water systems;
c. Operation of a water system after an order of closure was issued by the Department;
d. Plans and specifications of water systems of subdivisions and projects prior to the construction of housing
units thereat; and
e. Certification of potability of drinking water.

SEC. 11. Types of Water Examinations Required - The following examinations are required for drinking water:

a. Initial examination – The physical, chemical and bacteriological examinations of water from newly constructed
systems or sources are required before they are operated and opened for public use. Examination of water
for possible radioactive contamination should also be done initially.
b. Periodic examination – Water from existing sources is subject to bacteriological examination as often as possible
but the interval shall not be longer than six months, while general systematic chemical examination shall be
conducted every 12 months or oftener. Examination of water sources shall be conducted yearly for possible
radioactive contamination.

SEC. 12. Examining Laboratories and Submission of Water Samples – The examination of drinking water shall be performed
only in private, or government laboratories duly accredited by the Department. It is the responsibility of operators of water
systems to submit to accredited laboratories water samples for examination in a manner and at such intervals prescribed
by the Department.

SEC. 13. Other Protective Measures – To protect drinking water from contamination, the following measures shall be
observed:

a. Washing clothes or bathing wi1hin a radius of 25 meters from any well or other source of drinking water is
prohibited.
b. No artesian, deep or shallow well shall be constructed within 25 meters from any source of pollution.
c. No radioactive sources or materials shall be stored within a radius of 25 meters from any well or source of
drinking water unless the radioactive source is adequately safely enclosed by proper shielding.
 d. No person charged with the management of a public water supply system shall permit any physical connection
between its distribution, system and that of any other water supply, unless the latter is regularly examined as
to its quality by those in charge of the public supply to which the connection is made and found to be safe and
potable.
e. e. The installation of a booster pump to boost water direct from the water distribution line of a water supply
system, where low-water pressure prevails is prohibited.

DOH ADMINISTRATIVE ORDER NO. 2020-0031

• Revised Rules and Regulations Governing the Accreditation of Laboratories for Drinking Water Analysis

RATIONALE/BACKGROUND

• Chapter II (Water Supply) of Presidential Decree No. 856 or Code on Sanitation of the Philippines
o requires the initial and periodic examination of drinking water to be done by a DOH-Accredited water
testing laboratory.
• R.A. No. 9275 or the “Philippine Clean Water Act of 2004” and A.O. No. 2006-0024 known as the “Rules and
Regulations Governing the Accreditation of Laboratories for Drinking Water Analysis”,
o reiterated the importance to safeguard the safety and potability of drinking water in the country, through
the regulation of Laboratories for Drinking Water Analysis (LDWA).
• Agencies tasked to regulate LDWA:
o The Department of Health (DOH) through the Health Facilities and Services Regulatory Bureau (HFSRB)
o Regulation Licensing Enforcement Division of Center for Health Development (CHD-RLED)
o National Reference Laboratory for Environmental and Occupational Health, Toxicology and
micronutrient Assay (NRLEOHTM)
• Other Relevant Laws:
o A.O. No. 2017-0010
▪ The “Philippine National Standards for Drinking Water of 2017”
o R.A. No. 10657
▪ The “Chemistry Profession Act”

SCOPE AND COVERAGE

• This Order shall apply to all DOH offices, including its attached agencies, involved in the enforcement of drinking
water quality standards and to all accredited LDWA nationwide. It shall cover various government, national and
local agencies, private entities, person and enterprises engaged in testing drinking water.
• Drinking water laboratories for purely academic training and/or research and other laboratories
performing solely for internal or in-house monitoring shall not be covered by this Order.
CLASSIFICATION OF LDWA
• Classification by Ownership:
o Government
▪ operated and maintained partially or wholly by the national, provincial, city or municipal
government, or other political unit, or by any department, division, board or agency thereof.
o Private
▪ privately owned, established and operated with funds through donation, principal, investment
or other means, by any individual, corporation, association or organization.

• Classification by Institutional Character:

a. Institution based — a laboratory that is located within the premises and operates as part of a DOH licensed
health facility.
b. Non-institution based — a laboratory that operates independently and is not attached to any DOH licensed
health facility.

• Classification by Service Capability:

Classification Service Minimum Parameters Tested Minimum Workspace

Capability Requirement
A Microbiological Detects and enumerate coliform organisms (Total 20 sqm. for sterile room and
coliform, thermotolerant coliforms/[Link], and media preparation area
Heterotrophic Plate Count (HPC) in the water
samples

B Physio-Chemical Detects and quantify physical and chemical 50 sqm. for wet chemistry area,
characteristics of at least the nine (9) mandatory ICP/AAS room,
parameters as stated in the 2017 PNSDW namely: Spectrophotometer room, and
• Lead, Nitrate, Arsenic, Cadmium, Color, chemical storage room.
Turbidity, pH, disinfectant residual pH,
Total Dissolved Solids (TDS).

C Microbiological- Offers services both Category A and B 70 sqm. for sterile room and
Physio-Chemical media preparation
area, wet chemistry area,
ICP/AAS room,
Spectrophotometer room, and
chemical storage room
PERSONNEL

• Headship
o The head of the laboratory shall be a competent and experienced professional, with a
specialized skill set related to and proportionate to the laboratory category.
o The laboratory head is essentially responsible for the operation of entire laboratory, its
personnel, functions, and data, all of which shall meet the quality assurance criteria and
regulatory requirements.

• Analyst
o NRL-EOHTM trained
o Must have the appropriate degree and at least two (2) year-experience in water testing
procedures relevant to the service capability of the laboratory

Microbiology Physio-Chemical
• Registered Medical Technologist • Registered Chemist
• Certified Microbiologist • Registered Chemical Technician under
• Registered Food Technologist the supervision of a Registered
Chemist

o For microbiology, professionals contracted practice as analysts prior to the issuance of this Order
shall still be allowed.
o For water chemical analysis, only a Registered Chemist shall certify the result.

• Laboratory Aide
o Must have at least 8 hours (1 day) appropriate training (may be inhouse) in relevant laboratory
procedures.

• Water Sampler
o person who collects water sample
o must be certified by the DOH
CODE OF ETHICS OF THE MEDICAL TECHNOLOGY PROFESSION
• Professional Regulatory Board of Medical Technology Resolution No. 72 Series of 2022
• Code of Ethics was first published by the Philippine Association of Medical Technologist (PAMET) in 1968 prior
to the approval of R.A. No. 5527 in 1969. It was then revised in 1997
• Date of Effectivity: Oct. 02, 2022

ARTICLE I
GENERAL
PRINCIPLES

Section 1. The primary objective of the practice of medical technology/medical laboratory science is service to mankind, without
bias to a patient’s or colleague’s race, religion, gender, political belief or medical condition.

Section 2. A medical technologist shall commit to the highest degree of professionalism, excellence, competence and
integrity in the practice of the profession.

Section 3. A medical technologist shall adhere to principles of quality and safe practice.

Section 4. A medical technologist shall put the patients’ interest above his/her own. A medical technologist shall perform
his/her duties with competence and integrity and shall maintain the confidentiality of all the patients’ information in
accordance with the existing legislation.

Section 5. A medical technologist shall be accountable and responsible for his/her professional and personal conduct, and
is expected to demonstrate good judgment and behavior to ensure excellent laboratory performance for the best possible
patient care.

Section 6. A medical technologist shall contribute to the profession’s development through lifelong learning such as self-
development, mentorship, or collaboration with institutions and accredited local, national and international organizations
in medical technology.

Section 7. A medical technologist shall maintain allegiance and a deep sense of civic responsibility towards his/her
community and country.

Section 8. A medical technologist shall treat other professionals with respect and foster cooperation and collaboration among
them.

Section 9. A medical technologist shall refrain from engaging in activities which may give rise to conflict of interest.

ARTICLE II
RESPONSIBILITIES TO PATIENTS

Section 1. A medical technologist shall attend to patients faithfully, conscientiously and timely and shall secure for them all
possible benefits that may depend upon professional skill and care. A medical technologist shall be polite, courteous, attentive,
reassuring and caring.
Section 2. A medical technologist shall dutifully perform his/her tasks, regardless of the patient’s age, gender, creed, or
nationality.

Section 3. A medical technologist shall seek appropriate assistance, according to established protocols in situations beyond
his/her knowledge and skills.

Section 4. A medical technologist shall keep all patient’s information and results obtained with strict confidentiality, except
when the disclosure is required by pertinent laws, rules and regulations.

Section 5. A medical technologist shall only engage in lawful and appropriate procedures that promote the best interest
and safety of the patient.

ARTICLE III
RESPONSIBILITIES TO SELF AND TO THE PROFESSION

Section 1. A medical technologist shall personify professionalism, integrity, responsibility, accountability and competence in the
conduct of his/her professional as well as personal life.

Section 2. A medical technologist shall continuously update and upgrade knowledge and skills in the practice of the
profession brought about by modernization as well as scientific and technical advancements in the
profession.

Section 3. A medical technologist shall ensure compliance with the medical technology law, other related laws and
regulatory policies affecting the practice of the profession.

Section 4. A medical technologist is duty-bound to report to the proper authorities illegal acts and other violations in the
practice of the profession, including illegal practice, for the protection of the public.

Section 5. A medical technologist shall actively support and apply principles, policies and guidelines for the protection of the
environment, especially in biosafety and biosecurity practices.

Section 6. A medical technologist shall ensure compliance with Quality Assurance Program following the standards of Good
Laboratory Practice.

Section 7. A medical technologist shall endeavor to engage in community or social work where their services are needed,
such as but not limited to cases of emergency, disaster or other similar circumstances.

Section 9. A medical technologist shall fulfill the duties and responsibilities as a member of the accredited professional
organization through active participation in continuing professional development and other activities and to respect the
constitution and by-laws of the organization.

Section 10. The medical technologist shall accept reasonable professional fees on matters relative to research, consultancy,
and activities that require his/ her expertise in the field of medical laboratory science and/or allied sciences.
Section 11. A medical technologist shall accept, carry out and discharge the responsibilities inherent to being a professional.
He/she shall uphold the dignity of the profession by imbibing the virtues of reliability, honesty and integrity.

ARTICLE IV
RESPONSIBILITIES TO COLLEAGUES AND OTHER PROFESSIONALS

Section 1. A medical technologist shall establish cooperative, honest and respectful working relationships with other medical
technologists.

Section 2. A medical technologist shall act in the spirit of fairness and maintain a culture of fellowship with the members of the
medical technology and other professions.

Section 3. A medical technologist shall maintain harmonious working relationships with other professionals of different
interdisciplinary practice and respect the scopes and limitations of their practice vis-à-vis the other
professions.

ARTICLE V
PROFESSIONAL RELATIONSHIP WITH THE HEALTH PRODUCT INDUSTRY (HPI)

Section 1. A medical technologist shall collaborate with HPI for the advancement of medical technology and the quality of
healthcare services.

Section 2. A medical technologist shall foster a relationship that encourages the development of a healthcare professional
practice that is committed to patients' well-being and is based on truthful, accurate, and updated scientific evidence.

Section 3. A medical technologist shall interact with HPI to meet the highest ethical standards, preserve independent
decision-making and uphold public confidence in the integrity of patient care and product and service selection.

Section 4. A medical technologist shall collaborate with HPI within the bounds of applicable laws and codes of conduct for
the best interest of the patients.

Section 5. A medical technologist shall collaborate with HPI for professional advancement on new
technologies and equipment through educational and experiential training.
REVISED CODE OF ETHICS

As I enter the practice of Medical Technology, I shall:

• Accept the responsibilities inherent to being a professional

• Uphold the dignity and respect of my profession and conduct myself a reputation of reliability, honesty, and
integrity
• Perform my task with full confidence, reliability and accuracy.
• Treat any information I acquired about individuals in the course of my work as strictly confidential
• Commit myself to continuously improve my professional skills and knowledge
• Share my knowledge and expertise to my colleagues
• Contribute to the advancement of the professional organization and other allied health organizations
• Act in a spirit of fairness to all and a spirit of brotherhood to other members of the profession
• Restrict my praises, criticisms, views, opinions within constructive limits
• Accept employment from more than one employer only when there is no conflict of interest
• Be dedicated to the use of Clinical laboratory science to promote life and benefit mankind
• Uphold the law and shall not engage in illegal work
• Report any violation of the above principles of professional conduct to the authorized agency and the ethics
committee of the organization.

To these principles, I hereby subscribe and pledge to conduct myself at all times in a manner befitting the dignity of my
profession.