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MEDICAL TECHNOLOGY LAWS AND BIOETHICS
RA 5527 AND ITS AMENDMENTS

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INTRODUCTION: RA 5527 PHILIPPINE MEDICAL TECHNOLOGY ACT OF 1969


- Signed on June 21 1969
- Medical Technology became a profession
- Medical Technologists became professionals
- United States of America
● From 6th preference category to 3rd preference category

AMENDMENTS ON RA 5527
1. RA 6138 (August 31 1970)
a. Sec 16 - Qualification for Examination
● Added: good health, good moral character, graduated BS Medical Technology or BS Public
Health and Hygiene
b. Sec 21 - Issuance of Certificate of Registration
● Board passers can receive Certificate of Registration (CoR), 21 years of age to be issued CoR
c. Sec 22 - Fees
● Fees have been updated
2. PD 498 (June 28 1974)
a. Sec 2 - Definition of Terms
b. Sec 3 - Council of Medical Technology Education, Its Composition
c. Sec 4 - Compensation and Travelling Expenses of Council Members
d. Sec 7 - Medical Technology Board
e. Sec 8 - Qualification of Examiners
f. Sec 11- Functions and Duties of the Board
g. Sec 13 - Accreditation of Schools of Medical Technology and of Training Laboratories
h. Sec 16 - Qualification of Examination
i. Sec 17 - The Scope of Examination
j. Sec 21 - Issuance of Certificate of Registration
k. Sec 29 - Penal Provisions
3. PD 1534 (June 11 1978)
a. Sec 3 - Council of Medical Technology Education, Its Composition
b. Sec 8 - Qualification of Examiners
c. Sec 13 - Accreditation of Schools of Medical Technology and of Training Laboratories

MEDICAL TECHNOLOGY LAWS OF 2011


1. House Bill #4032: Cong. Janette Garin (Ilo Ilo)
2. Senate Bill #2722: Sen. E Angara
a. Feb 28 2011
b. Phlebotomy exam: September
c. MT Exam: May & November

RA 5527 PHILIPPINE MEDICAL TECHNOLOGY ACT OF 1969 ​(*As amended by RA 6132, PD 498 and PD 1534.)
- An Act Requiring the Registration of Medical Technologist, Defining Their Practice, and for Other Purposes

Section 1. ​Title.​
This Act may be also cited as the Philippine Medical Technology Act of 1969.
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Section 2.​ ​Definition of Terms.​


As used in this Act,the following terms shall mean:
a. Practice of Medical Technology - A person shall be deemed to be in the practice of medical technology within the
meaning of this Act, who shall for a fee, salary or other compensation or reward paid or given directly or indirectly through
another, renders any of the following professional services for the purpose of aiding the physician in the diagnosis, study
and treatment of diseases and in the promotion of health in general:
1. Examination of tissues, secretions and excretions of the human body and body fluids by various electronic,
chemical, microscopic, bacteriologic, hematologic, serologic, immunologic, nuclear, and other laboratory
procedures and techniques either manual or automated;
2. Blood banking procedures and techniques;
3. Parasitologic, Mycologic and Microbiologic procedures and techniques;
4. Histopathologic and Cytotechnology; provided that nothing in this paragraph shall inhibit a duly registered
medical laboratory technician from performing histopathologic techniques and procedures.
5. Clinical research involving patients or human beings requiring the use of and/or application of medical
technology knowledge and procedures;
6. Preparations and standardization of reagents, standards, stains and others, provided such reagents,
standards, stains and others are exclusively for the use of their laboratory;
7. Clinical laboratory quality control;
8. Collection and preservation of specimens;

Provided, That any person who has passed the corresponding Board examination for the practice of a profession already
regulated by existing law, shall not be subject to the provisions of the last four preceding paragraphs if the performance of
such acts or services is merely incidental to his profession.

b. Pathologist​ - A duly registered physician who is specially trained in methods of laboratory medicine, or the gross and
microscopic study and interpretation of tissues, secretion and excretions of the human body and its functions in order to
diagnose disease, follow its course, determine the effectivity of treatment, ascertain cause of death and advance medicine
by means of research.

c. Medical Technologist​ - A person who engages in the work of medical technology under the supervision of a pathologist
or licensed physician authorized by the Department of Health in places where there is no pathologist and who having
passed the prescribed course (Bachelor of Science in Medical Technology/Bachelor of Science in Hygiene) of training and
examination is registered under the provision of this Act.

d. Medical Laboratory Technicians ​- A person certified and registered with the Board as qualified to assist a medical
technologist and/or qualified pathologist in the practice of medical technology as defined in this Act.

e. Accredited Medical Technology Training Laboratory​ - A clinical laboratory, office, agency, clinic, hospital or sanitarium
duly approved by the Department of Health​2​ or its authorized agency.

f. Recognized School of Medical Technology ​- Any school, college, or university which offers a course in Medical
Technology approved by the Department of Education in accordance with the requirements under this Act, upon
recommendation of the council of medical technology education.

g. Council ​- The council of medical technology education established under this Act.

h. Board​ - The Board of Examiners for Medical Technology established under this Act.
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Section 3.​ Council of Medical Technology Education, Its Composition.
There is hereby established a Council of Medical Technology Education, hereafter referred to as Council, which shall be
composed of the Director of Higher Education as Chairman; the Chairman of the Professional Regulation Commission as
Vice-Chairman; and the Director of the Bureau of Research and Laboratories of the Department of Health,4 the Chairman
and two (2) members of the Board of Medical Technology, a representative of the Deans of Schools of Medical
Technology and Public Health, and the Presidents of the Philippine Society of Pathologists and the Philippine Association
of Medical Technologists, as members.

SUMMARY
● Chairman
○ Director of Higher Education
● Vice-Chairman
○ Chairman of the Professional Regulation Commission
● Members
○ Director, Bureau of Research and Laboratories, DOH
○ Chairman and two (2) members of MT boards
○ Representative of the Deans of Schools of MT and PH
○ President, PSP
○ President, PAMET

Section 4. ​Compensation and Traveling Expenses of Council Members.


- For every meeting actually attended, the Chairman shall be entitled to a fifty pesos (P50.00) per diem while the members
shall be entitled to twenty-five pesos (P25.00) each regardless of whether or not they receive regular salaries from the
government. In addition, the Chairman and members of the Council shall be entitled to traveling expenses in connection
with their official duties.

SUMMARY
● Chairman
○ Php 50.00 per diem
● Members
○ Php 25.00 each
○ Regardless of whether or not they receive regular salaries from the government

Section 5. ​Functions of the Council of Medical Technology Education.


The functions of the Council shall be:
a. 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, 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 students who have satisfactorily completed three years
of the medical technology course or its equivalent and to collect from said student 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.
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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 ● Gross Anatomy


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

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.
1. RA 5527: BS MT is a 4 year course including 12 mos internship
2. CHED Memo. Order (CMO) #14 series of 2006: policies, standards, and guidelines for MT education
a. MLS: 6 months internship

Section 7. ​Medical Technology Board.


There is hereby created a Medical Technology Board under the Professional Regulation Commission, which shall
thereafter be referred to as the Board composed of a Chairman who is a pathologist, and two (2) members who are
registered medical technologists who shall be appointed by the President of the Republic of the Philippines upon
recommendation of the Professional Regulation Commission. The Chairman and members of the Board shall hold office
for three (3) years after appointments or until their successors shall have been appointed and duly qualified: Provided,
That the incumbent members will continue to serve until the expiration of their terms. In case of death, disability, or
removal of a member of the Board, his successor shall serve only the balance of his term.

SUMMARY
● Appointed by the President of the Philippines
○ Chairman: Pathologist
○ Members (2): RMT
○ Appointment: Three (3) years
● September 1970: First examination for MT
○ Chairman
■ Dr. Arturo D Tolentino, Jr.
○ Members:
■ Felix E. Asprer
■ Azucena S.J. Vizconde
● Medical Technology Board
○ Composition
■ Chairman: Pathologist
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■ 2 Members: RMT
○ Current Board members
■ Chairman
● Marilyn A. Cabal-Barza
■ Members
● Marilyn R. Atienza
● Marian M. Tantingco

Section 8. ​Qualifications of Examiners.


-No person shall be appointed as member of the Board of Examiners for Medical Technology unless he or she is (1) is a
Filipino citizen; (2) is of good moral character; (3) is a qualified Pathologist, or a duly registered medical technologist of the
Philippines with the degree of Bachelor of Science in Medical Technology/Bachelor of Science in Hygiene/Public Health;
(4) has been in practice of laboratory medicine or medical technology for at least ten years prior to his appointment, and
(5) is not a member of the faculty of any medical technology school for at least two (2) years prior to appointment or
having any pecuniary interest direct or indirect in such institution: Provided, however, That for the first three years
following the approval of this Act, the requirements mentioned in number four (4) shall be reduced to five years.

SUMMARY
● Filipino Citizen
● Good moral character
● Qualified Pathologist (Chairman) ; Registered Medical Technologist (Members)
● Has been in practice of medical technology for at least 10 years
● Not a member of the faculty of any medical technology school for at least 2 years or having any pecuniary
interest direct or indirect in such institution

Section 9. ​Executive Officer of the Board.


SUMMARY
● PRC commissioner
● RA 8981: PRC Modernization Act of 2000 (December 5 2000)
● PRC Chairperson

Section 10. ​Compensation of Members of the Board of Examiners for Medical Technology.
Each member of the Board shall receive as sum of ten pesos for each applicant examined and five pesos for each
applicant granted a certificate of registration without examination.

SUMMARY
● Each member of the Board shall receive as sum of
○ 10 pesos for each applicant examine
○ 5 pesos for each applicant granted a certificate of registration without examination

Section 11. ​Functions and Duties of the Board.


-he 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;
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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.

SUMMARY
● Administer the provisions of this Act
● Administer oaths to the board passers
● Issue, suspend and revoke certificates of registration
● Look into problems affecting MT profession
● Investigate violations of RA 5527
● Draft such rules and regulations as may be necessary to carry out the provisions of RA 5527 but to be
approved the President
● To determine the adequacy of the technical staff of all clinical laboratories and blood banks
● To prescribe the qualifications and training of medical technologists
● To classify and prescribe the qualification and training of the technical staff of clinical laboratories

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.

SUMMARY
● Removed by the President of the Philippines
● Ground for removal of the board members
○ Neglect of duty
○ Incompetency
○ Malpractice
○ Unprofessional, unethical, immoral or dishonorable conduct
○ Death
○ Disability

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


Upon the recommendation of the Medical Technology Board, the Department of Education and Culture15 shall approve
schools of Medical Technology in accordance with the provisions of this Act, as amended, in conjunction with the Board of
Medical Technology. The Department of Health​16 through the Bureau of Research and Laboratories shall approve
laboratories for accreditation as training laboratories for medical technology students or postgraduate trainees in
conjunction with the Board of Medical Technology. The laboratories shall show satisfactory evidence that they possess
qualified personnel and are properly equipped to carry out laboratory procedures commonly required in the following
fields: Clinical Chemistry, Microbiology, Serology, Parasitology, Hematology, Blood Banking, Clinical Microscopy, and
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Histopathologic techniques, and that the scope of activities of said laboratories offer sufficient training in said laboratory
procedures.

SUMMARY
● Department of Health​16​ (through the Bureau of Research and Laboratories) shall approve laboratories for
accreditation as training laboratories
○ The laboratories shall show satisfactory evidence that they possess qualified personnel
○ Properly equipped to carry out laboratory procedures commonly required in the following fields
● CMO #6 s. 2008: Accreditation of Clinical Laboratories as Training Laboratory for Medical Technology/Medical
Laboratory Science Interns
○ Clin. Lab licensed by DOH through BHFS shall apply to CHED as training lab

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.

SUMMARY
● Not inhibited
○ Registered physicians
○ Consultant and professors from other country
○ Medical technologists in the service of the United States Armed Forces stations in the Philippines
● Inhibited
○ Board flunkers

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.

SUMMARY
● Given annually in
○ Manila (Luzon)
○ Cebu (Visayas)
○ Davao (Mindanao)
● At least 50 examiners
○ Baguio
○ Legaspi
○ Ilo-ilo
● Batches
○ 1st Batch
■ Last week of August or first week of September
○ 2nd Batch
■ March
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● Written notices of examination
○ Published in at least three newspapers of national circulation by the Secretary of the Board of at least
30 days prior to the date of examination
● Deadline of application
○ 20 days before the exam
● Requirements
○ TOR with scanned picture
○ NSO copy of birth certificate
○ If married, NSO: marriage contract
○ Community tax certificate (cedula)
○ 4 passport-sized picture with name
○ Php 900

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.

SUMMARY
● Qualification of applicant
○ Is in good health and is of good moral character
○ Has completed BSMT or BSPH
○ Graduate of other profession: must performed MT for 5 years. Practice began prior to June 21, 1969

Section 17. ​Scope of Examination.


The examination questions shall cover the following subjects with their respective relative weights:

● Clinical Chemistry ...................................................... 20% - 100 items


● Microbiology & Parasitology ....................................... 20% - 100 items
● Hematology ............................................................... 20% - 100 items
● Blood Banking & Serology ......................................... 20% - 100 items
● Clinical Microscopy (Urinalysis and
other body fluids) ...................................………......... 10% - 100 items
● Histopathologic Techniques,
Cytotechnology, Medical
Technology Laws, Related
Laws and its implementing
rules, and the Code of Ethics ........................……….. 10% - 100 items

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.
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SUMMARY
● Schedule of subjects to be published
○ At least thirty (30) days before the date of examination

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.

SUMMARY
● The Board report the result within 120 days
○ Commissioner of Civil Service
■ President of the Philippines for approval
● RA 8981: PRC modernization act of 2000
○ Within 10 days

Section 19.​ Rating in the Examination.


In order to pass the examination, a candidate must obtain a general average of at least seventy-five percent in the written
test, with no rating below fifty percent in any of the major subjects: Provided, That the candidate has 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: Provided, That graduate of paramedical
profession other than Bachelor of Science in Medical Technology/Bachelor of Science in Hygiene admitted to an
examination under the provisions of this Act shall not be given further examinations after the provisions of this Act shall be
given further examinations after his failure to qualify for the third time.

SUMMARY
● How to pass the board exam
○ General average of at least 75%
○ No rating below 50% in any of the major subjects
○ Not failed in at least 60% of the subjects
○ 12 months refresher course after failure to qualify for the third time
○ Or 12 months post graduate training in an accredited laboratory

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.

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 as such: Provided, That no such certificate shall be issued to any successful applicant who has
not attained the age of twenty-one (21) years. All certificate shall be signed by the members of the Board and by the
Commissioner of the Professional Regulation Commission. The duly registered medical technologists shall be required to
display his certificate of registration in the place where he works. Provided, that upon application filed and the payment of
the required fee of one hundred and fifteen pesos (P115.00) the Board shall issue a certificate of registration as medical
technologist without examination to persons who have been graduated with Bachelor of Science in Medical
Technology/Bachelor of Science in Public Health in duly recognized schools of medical technology in the Philippines or in
any foreign country, Provided, That in case of the latter, the standard of medical technology education is substantially the
same as ours, and in addition shall have been in the practice of medical technology for at least three (3) years prior to the
filing of the application in laboratories in the Philippines duly accredited by the Bureau of Research and Laboratories,
Department of Health, or in foreign countries if such performance began prior to June 21, 1969 and also to all other
persons who having graduated from other professions have been actually performing medical technology practice for the
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last eight (8) years prior to filing of the application, Provided, that such performance began prior to June 21, 1969.
Provided, further, that the Board shall likewise issue a certificate of registration as medical laboratory technician without
examination to any person who upon application and payment of the required fee of fifty pesos (P500.00) show evidence
satisfactory to the Board that:
1. He or she passed the civil service examination for medical technician given on March 21, 1964; or
2. Has finished a two-year college course and has at least one (1) year of experience as medical laboratory
technician, Provided, that for every year of deficiency in college attainment two (2) years of experience may be
substituted; Provided, further, that an applicant who has at least ten (10) years of experience as medical
laboratory technician as of the date of approval of this Decree regardless of his academic attainment may qualify
for registration without examination; or
3. Has failed to pass the board examination for medical technology but had obtained a general rating of at least
70%. Provided, finally, that a registered medical laboratory technician when employed in the government shall
have the equivalent civil service eligibility not lower than second grade.

SUMMARY
● Signatories
○ PRC chairperson (1)
○ MT Board (3)
● Must be displayed at the workplace
● The Board shall refuse to issue a CoR to
○ Convicted by legal court
○ Immoral or dishonorable conduct
○ Unsound mind
○ Incurable, communicable disease
○ Under legal age (less than 21 years old)
● RMTs shall be required to display his CoR in the place where he works
● CoR as MT without examination
○ Graduate of MT, Practice MT for 3 years, began prior to June 21, 1969
○ Graduate of other profession, practice MT for 8 years began prior to June 21, 1969
● Medical Laboratory Technician
○ Passed the civil service examination for medical technician given on March 21, 1964
○ Finished a two-year college course and has at least one (1) year of experience as medical laboratory
technician
○ General rating of 70% to 74.9%
● 1 RMT can handle 2 MLTs

Section 22. ​Fees.


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.

SUMMARY
● The Board shall charge each applicant for
○ Fee of examination
○ Registration
○ Issuance of CoR
○ New certificate lost, destroyed or mutilated
● 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.
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Section 23. ​Refusal to issue Certificate.
The Board shall refuse to issue a certificate of registration to any person convicted by the court of competent jurisdiction
of any criminal offense involving moral turpitude, or any person guilty of immoral or dishonorable conduct, or of unsound
mind, or incurable communicable disease, and in such shall be give to the applicant a written statement setting forth the
reason for its action, which statement shall be incorporated in the record of the Board.

SUMMARY
● The Board shall refuse to issue a CoR to
○ Any person convicted by court
○ Immoral or dishonorable conduct
○ Unsound mind
○ Incurable, communicable disease

Section 24. ​Administrative Investigation.


Revocation or Suspension of Certificates - Administrative investigation shall be conducted by at least two members of the
Board with one legal officer sitting during all administrative proceedings, the respondents shall be entitled to be
represented by counsel or be heard in person, to have a speedy and public hearing, to confront and cross-examine
witnesses against him or her, and to all other rights guaranteed by the Constitution. The Board may, after giving proper
notice and hearing to the party concerned reprimand an erring medical technologist or revoke or suspend his certificate of
registration for causes mentioned in the next preceding section or for causes enumerated in section twenty-nine (29) of
this Act, or for unprofessional conduct, malpractice, incompetency, or serious ignorance or gross negligence in the
practice of medical technology. No penalty of revocation shall be imposed unless there is a unanimous vote of all the
three members of the Board. The Board may, by majority vote, impose the penalty or reprimand or suspension, the latter
however not to exceed two years. When the penalty of suspension or revocation is imposed by the Board the medical
technologist shall be required to surrender his certificate of registration within thirty days after the decision becomes final,
under the pain of perpetual disqualification from the practice of medical technology in the Philippines for inexcusable
failure to do so. The suspension shall run from the date of such surrender.

SUMMARY
● Investigation conducted by
○ At least 2 members of the Board
○ With the presence 1 legal officer
● Sanctions
○ Suspension of license - majority vote
○ Revocation of license - unanimous vote
● Suspension
○ Not more than 2 years

Section 25.​ Appeal.


The revocation or suspension of a certificate made by the Board shall be subject to appeal to the Civil Service
Commissioner​24 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.

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.
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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.

Section 28.​ Roster of Medical Technologist.


A roster of Medical Technologist shall be prepared annually by the Secretary of the Board, commencing on the year
following that in which this Act shall become effective. 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. The roster shall be 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.

SUMMARY
● A roster of Medical Technologist shall be prepared annually by the Secretary of the Board
● Name, address and citizenship, date of registration

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​28​ for the purpose of carrying out the provisions of this Act.

SUMMARY
● Illegal Practice
○ Practice without registration in PRC
○ Practice without supervision of Pathologist
○ Making fraudulent laboratory report
○ Failure to display his CoR in the place where he works
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■ Fine: Php 2000 - 5000
■ Imprisonment: 6 months - 2 years
○ Using CoR of another RMT
○ Presenting false evidence in order to get CoR
○ Impersonating
○ Using revoked/suspended CoR
○ Advertising RMT title without CoR
○ Employment of someone who is not RMT

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.

ADDITIONAL NOTES
● If any provision of RA 5527 is declared invalid, the rest will not be affected

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

Section 32. ​Effectivity.


This Act shall take effect upon its approval.

ADDITIONAL NOTES
● Gil J Puyat
○ Senate President
● Jose B. Laurel, Jr.
○ Speaker of the House of Representatives
● Inocencio B. Preja
○ Secretary of the House of Representatives
● Ferdinand E. Marcos
○ President of the Philippines

Approved, June 21, 1969.


C. Lavin
MEDICAL TECHNOLOGY LAWS AND BIOETHICS
RA 8981: PRC MODERNIZATION ACT OF 2000

_________________________________________________________________________________________________

RA 8981: PRC MODERNIZATION ACT OF 2000


AN ACT MODERNIZING THE PROFESSIONAL REGULATION COMMISSION, REPEALING FOR THE PURPOSE
PRESIDENTIAL DECREE NUMBERED TWO HUNDRED AND TWENTY-THREE (223), ENTITLED “CREATING THE
PROFESSIONAL REGULATION COMMISSION AND PRESCRIBING ITS POWERS AND FUNCTIONS,” AND FOR
OTHER PURPOSES

SECTION 1. ​Title
This Act shall be called the "PRC Modernization Act of 2000."

Section 2. ​Statement of Policy


The State recognizes the ​important role of professionals in nation-building and, towards this end, promotes the
sustained development of a reservoir of professionals whose competence has been determined by ​honest and credible
licensure examinations and whose standards of professional service and practice are internationally recognized and
considered world-class brought about the regulatory measures, programs and activities that foster professional growth
and advancement.

Section 3. ​Professional Regulation Commission


There is hereby created a three-man commission to be known as the ​Professional Regulation Commission​, hereinafter
referred to as the Commission, which shall be attached to the office of the President for general direction and
coordination.

Section 4.​ Composition


The Commission shall be headed by one (1) full-time Chairperson and two (2) full-time Commissioners, all to be
appointed by the President for a term of seven (7) years without reappointment to start from the time they assume office.
Appointments to a vacancy that occurs before the expiration of the term of a Commissioner shall cover only the unexpired
term of the immediate predecessor. At the expiration of the Chairperson, the most senior of the Commissioners shall
temporarily assume and perform the duties and functions of
the Chairperson until a permanent Chairperson is appointed by the President.
● Chairperson: Hon. Teofilo S. Pilando, Jr.
● Commissioners: Hon. Yolanda D. Reyes and Hon. Jose Y. Cueto

The Chairperson or Commissioner shall be atleast:


1. Forty (40) years of age
2. Holding a valid certificate of registration/professional license and a valid professional identification card or a valid
certificate of competency issued by the Commission or a valid professional license issued by any government
agency.
3. Familiar with the principles and methods of professional regulation and/or licensing and has had at least five (5)
years of executive or management experience: provided that, one (1) of the Commissioners must be a past
chairperson/member of a Professional Regulatory board.

Section 5. ​Exercise of Powers and Functions of the Commission


The Chairperson of the Commission, and the Commissioners as members thereof shall sit and act as a body to exercise
general administrative, executive and policy-making functions of the Commission. The Commission shall establish and
maintain a ​high standard of admission to the practice of all professions and at all times ​ensure and safeguard the
integrity of all licensure examinations.
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The Chairperson shall act as the presiding and chief executive officer of the Commission:
● As presiding officer, he/she shall preside over the meetings of the Commission sitting as a collegial body.
● As chief executive officer of the Commission, he/she shall be responsible for the implementation of the policies
and the programs adopted by the Commission for the general administration of the Commission.
● He/she shall perform such other activities which are necessary for the effective exercise of the powers, functions
and responsibilities of the Commission.

Section 6.​ Compensation and Other Benefits


The Chairperson shall receive compensation and allowances equivalent to that of a Department Secretary while the
Commissioners shall receive compensation and allowances equivalent to that of an Undersecretary. The Chairperson and
the members of the Commission shall be entitled to retirement benefits provided under Republic Act Numbered Fifteen
Hundred and Sixty Eight (RA 1568), as amended by Republic Act Numbered Three Thousand Five Hundred and Ninety
Five (RA 3595).

Section 7. ​Powers, Functions and Responsibilities of the Commission


The powers, functions, and responsibilities of the Commission are as follows:
1. To administer, implement and enforce ​the regulatory policies of the national government with respect to the
regulation and licensing of the various professions and occupations under its jurisdiction including the
enhancement and maintenance of professional and occupational standards and ethics and the enforcement of the
rules and regulations relative thereto:
2. To perform any and all acts, enter into contracts, make such rules and regulations and issue such orders and
other administrative issuance as may be necessary in the execution and implementation of its functions and the
improvement of its services;
3. To ​review, revise, and approve resolutions, embodying policies promulgated by the Professional
Regulatory Boards in the exercise of their powers and functions or in implementing the laws regulating their
respective professions and other official actions on non-ministerial matters within their respective jurisdictions;
4. To administer and conduct the licensure examinations ​of the various regulatory boards in accordance with the
rules and regulations promulgated by the Commission; determine and ​fix the places and dates of
examinations; use publicly or privately owned buildings and facilities for examination purposes; conduct
more than one (1) licensure examination:
● Provided, That, when there are two (2) or more examinations given in a year, at least one (1)
examinations shall be held on weekdays (Monday to Friday):
● Provided, further, That, if only one (1) examination is given in a year, this shall be held ​only on
weekdays​:
● Provided, finally, That, the Commission is also authorized to ​require the completion of a refresher
course​ where the examinee has ​failed to pass three (3) times, except as otherwise provided by law​;
● Approve the results of examinations and the release of the same;
● Adopt measures to preserve the integrity and inviolability of licensure examinations;
● Appoint supervisors and room watchers from among the employees of the government and/or
private individuals with baccalaureate degrees​, who have been trained by the Commission for the
purpose and who shall be entitled to a reasonable daily allowance for every examination day actually
attended, to be determined and fixed by the Commission;
● Publish the list of successful examinees;
● Provide schools, colleges and universities, public and private, offering courses for licensure examinations,
with copies of sample test questions on examinations recently conducted by the Commission and copies
of the syllabi or terms of specifications of subjects for licensure examinations;
● And impose the penalty of ​suspension or prohibition from taking licensure examinations to any
examinee charged and found guilty of violating the rules and regulations governing the conduct
of licensure examinations promulgated by the Commission
5. To admit the successful examinees to the practice of the profession or occupation;
● Cause the entry of their names on its registry book and computerized database;
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● Issue certificates of registration/professional license, bearing the ​registrant’s name, picture, and
registration number, signed by all the members of the Board concerned and the Chairperson, with
the official seal of the Board and the Commission affixed thereto which certificate shall be the
authority to practice​;
● And at the option of the professional concerned, ministerially issue the professional identification card, to
be used solely for the purpose of identification, upon payment of the appropriate amount
6. To have custody of all the records of the various Boards, including examination papers, minutes of deliberation,
records of administrative cases and investigations and examination results for control and disposition;
7. 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
8. To authorize any officer of the Commission to administer oaths:
9. To supervise foreign nations who are authorized by existing laws to practice their professions either as holders of
a certificate of registration and a professional identification card or a temporary special permit in the Philippines;
● To ensue that the terms and conditions for their practice or of their employment are strictly complied with;
● To file upon due process request for deportation with the Bureau of Immigration and Deportation (BID);
and to supervise professionals who were former citizens of the Philippines and who had been
registered and issued a certificate of registration and a professional identification card prior to their
naturalization as foreign citizens, who may, while in the country on a visit, sojourn or permanent
residence, practice their profession
10. To ​monitor the performance of schools in licensure examinations and publish the results thereof in a
newspaper of national circulation;
11. To adopt and institute a ​comprehensive rating system ​for universities, colleges, and training institutes based on
the passing ratio and overall performance of students in board examinations;
12. To exercise​ administrative supervision​ over the various professional regulatory boards and its members;
13. To implement the program for the ​full computerization of all licensure examinations given by the various
professional regulatory boards
14. To investigate ​motu proprio or upon the filing of a verified complaint, any member of the Professional Regulatory
Boards for
● Neglect of duty
● Incompetence, unprofessional, unethical, immoral or dishonorable conduct
● Commission of irregularities in the licensure examinations which taint or impugn the integrity and
authenticity of the results of the said examinations
● And if found guilty, to revoke or suspend their certificates of registration and professional
licenses/identification cards and to recommend to the President of the Philippines their suspension or
removal from office
15. To issue summons, ​subpoena and subpoena duces tecum in connection with the investigation of cases against
officials and employees of the Commission and the members of the Professional Regulatory Boards;
16. To initiate an investigation, upon complaint under oath by an aggrieved party, of any person, whether a
private individual or professional, local or foreign​, who practices the regulated profession or occupation
without being authorized by law, or without being registered with and licensed by the concerned regulatory board
and issued the corresponding license/professional identification card or temporary or special permit, or who
commits any of the prohibited acts provided in the regulatory laws of the various professions, which acts are
criminal in nature
17. To prepare an ​annual report of accomplishments on the programs, projects and activities of the
Commission during the year for submission to Congress after the close of its calendar year and make
appropriate recommendations on issues and/or problems affecting the Commission, the Professional Regulatory
Board

Section 8. Regional Offices


The Commission is hereby authorized to create regional offices as may be necessary to carry out their functions
mandated under this Act.
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Section 9.​ Powers, Functions and Responsibilities of the Various Professional Regulatory Boards
The various, professional regulatory boards shall retain the following powers, functions and responsibilities:
1. To regulate the practice of the professions in accordance with the provisions of their respective professional
regulatory laws;
2. 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
3. To delegate the hearing or investigation of administrative cases filed before them except in cases where the issue
or question involved strictly concerns the practice of the profession or occupation, in which case, the hearing shall
be presided over by at least one (1) member of the Board concerned assisted by a Legal or Hearing Officer of the
Commission;
4. To prepare, adopt and issue the syllabi or tables of specifications of the subjects for examinations in consultation
with the academe;
● Determine and prepare the questions for the licensure examinations which shall strictly be within the
scope of the syllabus or table of specifications of the subject for examination;
● Score and rate the examination papers with the name and signature of the Board member concerned
appearing thereon and submit the results in all subjects duly signed by the members of the Board to the
Commission within ten (10) days from the last day of examination unless extended by the Commission for
justifiable cause/s;

Section 10.​ Compensation of the Members of the Professional Regulatory Boards


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. ​Person to Teach Subjects for Licensure Examination on all Professions
All subjects for licensure examinations shall be taught by ​persons who are holders of valid certificates of registration
and valid professional licenses of the profession​ and who comply with the other requirements of the CHED.

Section 12. ​Assistance of Law Enforcement Agency


Any law enforcement agency shall, upon call or request of the Commission or of any Professional Regulatory Board,
render assistance in enforcing the regulatory law of the profession including the rules and regulations promulgated
thereunder by prosecuting the violators thereof in accordance with law and the rules of court.

Section 13.​ Appropriations


The amount necessary to carry out the initial implementation of this Act shall be charged against the current year’s
appropriations of the Professional Regulation Commission. Thereafter, such sums as may be necessary for the continued
implementation of this Act shall be included in the succeeding General Appropriations Act.

Section 14.​ Authority to Use Income


In addition to the annual appropriations of the Commission provided under the Annual General Appropriations Act, the
Commission is hereby authorized to use its income not exceeding the amount of Forty-five million pesos (P45,000,000.00)
a year for a period of five (5) years after the effectivity of this Act to implement the program for full computerization of the
operations of the Commission

Section 15. ​Penalties for Manipulation and Other Corrupt Practices in the Conduct of Professional Examinations
1. Any person who manipulates or rigs licensure examination results, secretly informs or makes known licensure
examination questions prior to the conduct of the examination or tampers with the grades in professional licensure
examinations shall,
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● Upon conviction, be punished by ​imprisonment of not less than six (6) years and one (1) day to not
more than twelve (12) years or a fine of not less than Fifty thousand pesos (P50,000.00) to not
more than One hundred thousand pesos (P100,000.00) or both such imprisonment and fine at the
discretion of the court.
2. In case the offender is an officer or employee of the Commission or a member of the regulatory board,
he/she shall be removed from office and shall suffer the penalty of perpetual absolute disqualification
from public office to addition to the penalties ​prescribed in the preceding section of this Act;
3. The penalty of imprisonment ranging from ​four (4) years and one (1) day to six (6) years or a fine ranging
from Twenty thousand pesos (P20,000.00) to not more than Forty-nine thousand pesos (P49,000.00), or
both imprisonment and fine at the discretion of the court​, shall be imposed upon the accomplices.

Section 16.​ Penalties for Violation of Section 7


Subparagraph (1) by Heads of Government Agencies or Officers of Private Entities/Institutions – Any head of a
government agency or officer(s) of a private firm/institution who violates Section 7 – subpar. (1) of this Act shall be
punished by imprisonment of not less than six (6) months and one (1) day to not more than six (6) years, or a fine of not
less than Fifty thousand pesos (P50,000.00) to not more than Five hundred thousand pesos (P500,000.00) or both at the
discretion of the court.

Section 17. Implementing Rules and Regulations


Within ninety (90) days after the approval of this Act, the Professional Regulation Commission, together with
representatives of the various Professional Regulatory Boards and accredited professional organizations, the DBM, and
the CHED shall prepare and promulgate the necessary rules and regulations needed to implement the provisions of this
Act.

Section 18. ​Transitory Provisions


The incumbent Commissioner and two (2) incumbent Associate Commissioners shall serve as Chairperson and
Commissioners respectively under the terms for which they have been appointed without need of new appointments.

Section 19. ​Separability Clause


If any provision of this Act or the application of such provision to any person or circumstances is declared invalid or
unconstitutional, the remainder of this Act or application of such provisions to other persons or circumstance shall not be
affected by such declaration.

Section 20. ​Repealing Clause


Republic Act. No. 546, Presidential Decree No. 223, as amended by Presidential Decree No. 657, Republic Act No. 5181,
and Executive Order No. 266, Series of 1995 are hereby repealed. Section 23 (h) of Republic Act No. 7836, Section 4 (m
& s). Section 23 of Republic Act No. 7920, and Section 29 of Republic Act No. 8050, insofar as it requires completion of
the requirements of the Continuing Professional Education (CPE) as a condition for the renewal of the license are hereby
repealed. All other laws, orders, rules and regulations or resolutions and all part/s thereof inconsistent with the provisions
of this Act are hereby repealed or amended accordingly.

Section 21.​ Effectivity


This Act shall take effect after fifteen (15) days following its publication in the Official Gazette or in two (2) newspapers of
general circulation, whichever is earlier.

Approved: December 05, 2000

(Sgd.) JOSEPH EJERCITO ESTRADA


President of the Philippines
C. Lavin
MEDICAL TECHNOLOGY LAWS AND BIOETHICS
RA 4688: 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

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 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.

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.

Approved, June 18, 1966.


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ADDITIONAL NOTES
RA 4688
- Clinical Laboratory Law
- Approved on June 18, 1966
- Promulgated for the purpose of preventing the operation and maintenance of substandard, improperly managed
and poorly equipped clinical laboratories

RA 4688: CLINICAL LAB LAW


● Implementing Guidelines
○ Administrative Order No. 201, Series of 1973
○ Administrative Order No. 290, Series of 1976
○ Administrative Order No. 52, Series of 1983
○ Administrative Order No. 49-B, Series of 1988
○ Executive Order No. 102, Series of 1999
■ Redirecting the Functions and Operations of the DOH
○ Administrative Order No. 2001-0059
■ Rules and Regulations Governing The Establishment, Operation and Maintenance of Clinical
Laboratories in the Philippines
○ Administrative Order No. 2007-0027
■ Revised Rules and Regulations Governing the Licensure and Regulation of Clinical
Laboratories in the Philippines
● AO 201 s. 1973
● EO 102 s. 1999
○ Redirecting the Functions and Operations of the DOH
● AO 59 s. 2001
○ Rules and Regulations Governing The Establishment, Operation and Maintenance of Clinical
Laboratories in the Philippines
● AO 27 s. 2007
○ Revised Rules and Regulations Governing the Licensure and Regulations of Clinical Laboratories in
the Laboratories

ADMINISTRATIVE ORDER NO. 2007-0027


● Objective
○ Promulgated to prescribe a revised minimum standard for clinical laboratories
● Scope and Coverage
○ Applies to all entities performing the activities and functions of clinical labs
○ Excludes government laboratories doing laboratory examinations limited to AFB microscopy, malaria
screening and cervical cancer screening; declared as extension of a licensed government clinical lab
XII. Appeal
● Office of the Health Sec within 10 days after receipt of notice of decision
● Decision is final and executory
XIII. Repealing Clause
XIV. Separability Clause
XV. Effectivity
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DEFINITION OF TERMS
● BHFS – Bureau of Health Facilities and Services
● CHD – Center for Health Development
● Critical Values – Panic values that needs for some corrective action
● EQAP – External Quality Assurance Program
● Mobile Clinical Laboratory – Moves from testing site but affiliated with base lab
● Satellite Testing Site – Any testing site that performs lab exams outside the physical confines of the base lab
● NRL – National Reference Laboratory
○ Government hospital lab designated by DOH and may or may not be a part of general clinical lab
○ DEPARTMENT MEMORANDUM NO. 2009-0086
■ Confirmatory testing
■ Surveillance
■ Resolution of conflicting results
■ Training; research
■ Implementation of EQAS
■ Evaluation of diagnostic kits and reagents
● POCT – Point of Care Testing (at or near the site of the patient)
● Routine Test – Basic, commonly requested
● STAT Tests – Urgent tests and to be released within one hour after procedure

CLASSIFICATION OF LABORATORIES
● Classification by Ownership
○ Government
○ Private
● Classification by Function
○ Clinical Pathology
○ Anatomic Pathology
● Classification by Institutional Character
○ Institution-based
○ Freestanding
● Classification by Service Capability
○ General Clinical Laboratory
■ Primary
● Routine hematory (CBC) – Hb, Hct, WBC & Diff. count
● Qualitative Platelet Determination
● Routine Urinalysis
● Routine Fecalysis
● Blood Typing (Hospital-based)
■ Secondary
*Primary lab services +
● Routine CLinical Chemistry – includes blood glucose, BUN, BUA, Creatinine and Total
Cholesterol
● Quantitative platelet determination
● Cross matching (Hospital-based)
● Gram staining (Hospital-based)
● KOH (Hospital-based)
■ Tertiary
*Secondary lab services +
● Special Chemistry
● Special Hematology
● Immunology/Serology
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● Microbiology (C/S)
■ Limited Service Capability (for institution based only)
● I.e. dialysis centers and social hygiene clinics
○ Special Clinical Laboratory
■ Offers highly specialized laboratory services that are usually not provided by a general clinical
laboratory
● Assisted Reproduction Technology Labs
● Molecular and Cellular Technology
● Molecular Biology
● Molecular Pathology
● Forensic Pathology
● Anatomic Pathology

GENERAL GUIDELINES
1. The LTO shall be issued only to clinical labs that comply with standard and technical reqts formulated by the
BHFS
2. Clinical labs operated and maintained for research and teaching purposes – exempted but needs to be
registered with BHFS
3. Special clinical labs are required to register with BHFS without being licensed (if not subject to other AO)
4. NRL – designated by DOH shall be covered by license of the clinical lab of the hospital
● Register only with BHFS if physically independent and duly accredited by international certifying body
i.e. CDC, WHO, or local body recognized by DOH
5. POL – required of license if doing any or all of the ff:
● Issue official lab results
● Perform more than monitoring exams
● Cater not only to physician’s own patients
6. POCT

SPECIFIC GUIDELINES
1. Standards
● Human Resources
● Equipment
● Glassware, Reagents & Supplies
● Administrative Policies & Procedures
● Technical Procedures
● Quality Assurance Program
● Communication & Records
● Physical facilities/ Work Environment
● Referral of Examinations Outside of the Clinical Lab
2. License to Operate
● Issued in the name of licensee and is non-transferrable
● Valid for one year and expires on the date set forth by CHD
● Capability to perform HIV testing and/or drinking water analysis shall be specifically indicated in the
LTO
● Mobile labs permitted to collect specimens only and operate within 100 kms radius from base lab
● Any substantial changes shall be reported to CHD within 2 weeks in writing
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PROCEDURAL GUIDELINES
1. Registration for Special Clinical Labs, NRL, Research & teaching labs
2. Procedures for Application for Initial/ Renewal of LTO
3. Renewal of LTO
● Hospital-based – processed under the One-Stop-Shop Licensure System for Hospitals
● Non-hospital based – beginning first day of October until end of November of current year (discount on
renewal fee)
● Automatic cancellation of LTO
○ Failure to submit duly accomplished form
○ Non-Payment of proper fee on or before expiration date
4. Inspection
● CHD shall conduct announced inspections at reasonable time using inspection tool
5. Monitoring
● BHFS/CHD Director or rep shall monitor clinical labs
● Notice of violation for non-compliant labs shall be issued immediately
● CHD concerned shall submit quarterly summary of violations to BHFS
● Provincial, City and Muntinlupa Health Officers can report existence of unlicensed labs
6. Reporting
● Bear the name and signature of Pathologist and RMT
● No report orally or in writing without directive from pathologist or associate except in emergency cases
7. Recording
● All requests and reports of all specimens submitted and examined
● Kept in file for at least 1 year
○ Anatomic and forensic pathology reports are kept permanently
8. Laboratory fees

VIOLATIONS
● Refusal on any clinical lab to participate in EQAP
● Issuance of a report, orally or in writing (in whole or part thereof) which is not in accordance with documented
procedures
● Permitting unauthorized persons to perform technical procedures
● Incompetence
● Deviations from standard test procedures
● Lending or using the name of licensed lab or head RMT to an unlicensed lab
● Unauthorized use of the name and signature of Pathologist and RMT to secure LTO
● Reporting a test result for clinical specimens even if the test was not actually done
● Transferring results of tests done in an outside lab to the results form of the referring lab
● Performing and reporting tests in a specialty or subspecialty in which the lab is not licensed
● Giving and receiving any commission, bonus or kickback or rebate or engaging in any split-free for referral to
clinical labs licensed by DOH

INVESTIGATION OF CHARGES OR COMPLAINTS


● BHFS/CHD Director or representative shall investigate the complaint
● BHFS/CHD Direct or representative shall suspend, cancel or revoke and may seek any law enforcement
agency to execute the closure of any erring lab when necessary

PENALTY
● Imprisonment of not less than 1 month; or
● Fine not less than Php 1000 but no more than Php 5000; or both
● If a corporation - managing head or owner is liable
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TECHNICAL STANDARDS AND MINIMUM REQUIREMENTS


● Staffing
○ Managed by licensed physician certified by the Philippine Board of Pathology
■ If not available – w. 3 months training on clinical lab medicine, QC and management may
manage a primary/secondary lab as certified by BHFS
○ RMTs– available at all times during operation hours
■ Hospital-based lab: at least 1 RMT/shift
○ Staff development & CPE program instituted
● Physical Facilities
○ Well ventilated, adequately lighted, clean and safe
○ Work space requirements (at least)
■ Primary– 10 m​2
■ Secondary– 20 m​2
■ Tertiary– 60 m​2

EQUIPMENT/INSTRUMENTS
PRIMARY SECONDARY TERTIARY

● Clinical centrifuge *All those in 1st plus the ff: *All those in 2nd plus the ff:
● Hemacytometer ● Refrigerator ● Incubator
● Microhematocrit centrifuge ● Photometer or its equivalent ● Balance
● Microscope with OIL ● Waterbath or its equivalent ● Rotator
● Hemoglobinometer or equivalent ● Timer or its equivalent ● Serofuge or its equivalent
● Differential counter or equivalent ● Autoclave
● Drying oven
● Biosafety cabinet (BSC) or its
equivalent
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MEDICAL TECHNOLOGY LAWS AND BIOETHICS


RA 7719: NATIONAL BLOOD SERVICES ACT OF 1994

_________________________________________________________________________________________________

REPUBLIC ACT NO. 7719


AN ACT PROMOTING VOLUNTARY BLOOD DONATION, PROVIDING FOR AN ADEQUATE SUPPLY OF SAFE
BLOOD, REGULATING BLOOD BANKS, AND PROVIDING PENALTIES FOR VIOLATION THEREOF

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

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;
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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
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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 (P25,000,000), by the Philippine Amusement and Gaming
Corporation (PAGCOR) with an initial amount of at least Twenty-five million pesos (P25,000,000), by the trust liability
account of the Duty Free Shop (Duty Free Philippines) with an initial amount of at least Twenty million pesos
(P20,000,000) 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
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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 (P50,000), 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 (P50,000) nor more than Five hundred thousand pesos (P500,000), 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 fortyeight
(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.

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.

Approved, May 5, 1994.


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ADDITIONAL NOTES
RA 7719
● National Blood Services Act
● PNRC – Philippine National Red Cross
● PBCC – Philippine Blood Coordinating Council
● PBC – Philippine Blood Center

VOLUNTARY BLOOD DONATION


● Before WWII, blood was collected and directly administered to patients
● With the advent of anticoagulants, blood could be preserved and stored in Blood Banks
● Voluntary Blood Donation began to be promoted after WWII

PNRC NATIONAL BLOOD PROGRAM


● Philippine National Red Cross launched the National Blood Program on July 17, 1948 with President E. Quirino
as the first Blood Donor
● The original objective of the NBP was “To maintain a constant and ready supply of whole blood or plasma at
least for emergency cases”

RA 1517: BLOOD BANK LAW


● Subsequently, some government and private hospitals set up blood banks
● Through the years, the demand for blood transfusion grew
● Because of the inability of the PNRC NBP and hospital blood banks to cope with this growing demand,
commercial blood banks were established
● In order to assure the safety of the supply of the blood from the hospital and commercial blood banks, the
government passed the Blood Bank Law in 1956
● Blood Donor’s Week is held annually on the second week of July
● An Act regulating the collection, processing and sale of human blood, and the establishment and operation of
blood banks and blood processing laboratories
● Approved on June 16, 1956
● Purpose —
○ Safeguarding and promoting public health and welfare by preventing improper collection, processing
and sale of human blood or its product to the public
● RA 1517 was repealed by RA 7719 (May 5, 1994)
● Implementing guidelines:
○ Administrative Order No. 9, Series of 1995
■ Rules and Regulations Implementing RA 7719
○ Administrative Order No. 17-A, Series of 1998
■ Requirements and Procedures for a License to operate a BB/ BC in the Philippines
○ Administrative Order No. 2005-0002
■ Rules and Regulations for the establishment of the Phil. Nat’l Blood Services
○ Administrative Order No. 2008-0008
■ Rules and Regulations Governing the Regulation of Blood Services Facilities
RA 7719
● National Blood Services Act of 1994
● Approved on May 15, 1994
● 15 Sections
● Purpose —
○ To promote voluntary blood donation
○ To provide safe, adequate, affordable and equitable blood products
○ To inform the public
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○ To require all blood banks/ centers to operate on a non profit basis
● The bill was initiated by the Committee on NBSP – filed in 1989 by Sen. R. Saguisag
● Promotes Voluntary Blood Donation and mandates a N V Blood Services Program
● Phases out commercial blood banks in two to four years
● Provides Duty-free importation of blood bank equipment, reagents, blood bags, and supplies
● Regulates Blood Services Facilities
● President of the Senate​ – Edgardo J. Angara
● Speaker of the House of Representatives​ – Jose De Venecia, JR
● Secretary of the Senate​ – Edgardo E. Tumangan
● Secretary General House of Representatives​ – Camilo L. Sabio
● President of the Philippines –​ Fidel V. Ramos

TERMS
1. Blood/ Blood product
● Refers to human blood, processed or unprocessed and includes blood components, its products and
derivatives
2. Anticoagulant
● Acid-citrate-dextrose — 21 days
● Citrate-phosphate- dextrose — 21 days
● CP​2​D — 35 days
● CPDA​1​ — 35 days
● CPDA​2​ — 42 days
● Heparin — 2 days

3. Blood Service Facility (BSF)


● Any unit, office, institution providing any of the blood transfusion services, which can be a Blood Bank,
Blood Center, a Blood Collection Unit, or a Blood Station;
● Classification of Blood Service Facility (BSF)
A) Ownership
a) 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 operation
b) 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
a) Hospital-based
— A BSF located within the premises of a hospital
b) 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
a) Blood Station (BS)
— A government or private hospital or PNRC chapter which has not been
licensed as a blood center but has been authorized by the DOH to store and issue
blood and blood product, and perform compatibility testing, when necessary
— Advocacy and promotion of voluntary blood donation and healthy lifestyle
— Provision of whole blood and packed red cells
— Storage, issuance, transport and distribution of whole blood packed red cells
— Compatibility testing of red cell units, if hospital-based
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b) Blood Collection Unit (BCU)
— An institution or facility duly authorized by the Department of Health to recruit and
screen donors and collect blood
— Advocacy and promotion of voluntary blood donation and healthy lifestyle
Recruitment, retention and care of voluntary blood donors
—Screening and selection of voluntary blood donors
—Conduct of health education and counseling services
—Collection of blood (mobile or facility-based) from qualified blood donors
—Transport of blood to BC for testing and processing
—Compatibility testing of red cell units, if hospital-based
c) Blood Bank (BB)
— 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
—Advocacy and promotion of voluntary blood donation and healthy lifestyle
—Storage and issuance of whole blood and blood components obtained from a BC
—The following services shall also be provided
● Compatibility testing for red cell units
● Direct Coombs test
● Red cell antibody screening
● Investigation of transfusion reactions
● Assist the HBTC in the conduct of post-transfusion surveillance
(hemovigilance)
d) Blood Center (BC)
—Advocacy and promotion of voluntary blood donation and healthy lifestyle
—Recruitment, retention and care of voluntary blood donors
—Collection of blood (mobile or facility-based) from qualified blood donors
—Conduct health education and counselling services
—Testing of units of blood for TTIs
—Processing and provision of blood components
—Storage, issuance, transport and distribution of units of whole blood and/or blood
products to hospitals and other health facilities
● Standards and Technical Requirements
○ The BSF appoints and allocates personnel who are suitably qualified, skilled and trained to
assume the responsibilities, authority, accountability and functions of the position
○ 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
○ All equipment and instruments necessary for the safe and effective provision of services are
available and are properly maintained
○ All reagents and glasswares to be used by the BSF shall be based on the minimum
requirement for sensitivity and specificity of testing reagents as the testing procedures as
recommended by the technical committee of the NVBSP
○ There shall be a system of reporting and recording of results of BSF examination
○ The BSF shall put into practice a quality assurance program
■ There shall be a policy on quality assurance program and continuous quality
improvement
■ 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-NVSP
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○ There shall be system in outsourcing of examinations and blood components


○ All hospital-based BB, BCU, and/or BS shall establish an Hospital Blood Transfusion
Committee (HBTC)
○ All BSF shall comply with policies and guidelines of the NVBSP
● License to Operate/ Authority to Operate
○ Hospital bases BBs, BCUs, and 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 CHD along with the other documentary requirements for the
hospital LTO
○ The LTO/ATO must be displayed at all times at a prominent place within premises
○ The CHD shall be notified within 15 calendar days of any change in management name or
ownership. In cases of transfer location, a new application for LTO/ATO shall be required
○ A separate LTO/ATO shall be required for each BSF or branch maintained in separate
premises even if operated by the same management
● Documentary requirements for the issuance of LTO/ATO
○ Certificate of inclusion in the Regional Blood Services Network approved by the identified Lead
Blood Center in the region
○ Duly accomplished and notarized application form
○ DTI/SEC registration (initial)
○ List of personnel with photocopy of valid PRC card
○ Location map (initial)
○ Floor diagram
○ List of equipment - with serial number, brand, date of purchase, number of units and
operational status
○ NVBSP Annual Blood Report (renewal)
○ Certificate of participation in EQAS in previous year (renewal)
● Inspection
○ The CHD director or his authorized representative/s inspects the BSF within 30 calendar days
from the time of application to determine compliance with standards and technical
requirements
○ The CHD inspection team prepares official summary of findings and recommends approval or
disapproval after inspection
● Validity of License to Operate
○ The LTO/ATO to operate a Blood Service Facility shall be valid for a period of 3 years
○ As part of the hospital license to operate, the license to operate/authority to operate a a
BB/BCU/BS shall be valid for a period of 1 year
● Violations
○ Any material false statement in the application
○ Misinterpretation of facts of falsification of documents or records
○ Refusal to make available its books, accounts and records of operation to an authorized person
from the BHFS/CHD
○ Charging of blood services fees above the maximum fees set by the DOH
○ Collection of blood from paid or remunerated donor whether payment comes from the hospital
or from the patient/ relatives
○ Refusal to participate in EQAS (External Quality Assessment Scheme) conducted by the
designated National Reference Laboratories

4. Hospital-based blood bank


● A blood bank which is located within the premises of a hospital and which can perform compatibility
testing of blood
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5. Commercial blood bank


● A blood bank that exists for profit, money or any material gain earned out of sale of, or exchange for,
blood or blood products which profit, money or any material gain are not used solely for the operation
and maintenance of the blood bank service
6. Apheresis Facility
● A blood service facility where blood collection procedure is done in which whole blood is removed, a
selected component separated and the remainder returned to the donor
7. End-User Hospital (EU)
● A hospital with a licensed clinical laboratory capable of red cell typing and cross-matching and which
does not have any blood components for blood transfusion as needed
8. End-User Non-Hospital Health Facility
● A licensed/accredited non-hospital health facility without a licensed clinical laboratory but which
administers blood transfusion
9. Blood Donors
A) Voluntary blood donors
— One who donates blood on one’s own violation or initiative and without monetary
compensation
B) Paid donors
C) Replacement donors
D) Walking Blood donors
—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 community
—Sec 4, paragraph (e)
● 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 center 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
10. Blood Services Network
● An informal organization composed of the designated blood centers and hospital blood banks, blood stations
and end-user hospitals established to provide for the blood needs of a specific geographical area

5 CORE TEST
1. Antibody to HIV, subtypes 1 & 2
2. Hepatitis B Surface Antigen
3. Antibody to Hepatitis C
4. Serologic Test for Syphilis (RPR/ VDRL)
5. Malaria

SECTION 4. PROMOTION OF VOLUNTARY BLOOD DONATION


● Public Education
● Promotion in Schools
● Profession Education
● Establishment of Blood Services Network
● Walking Blood Donors

SECTION 5. NATIONAL VOLUNTARY BLOOD SERVICES PROGRAM (NVBSP)


● The DOH, in cooperation with the PNRC and PBCC and other government agencies and nongovernmental
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 (budgetary allocation of the DOH)
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○ PCSO – Php 25,000,000
○ PAGCOR – Php 25,000,000
○ Duty Free Philippines – Php 20,000,000
○ Contributions of other agencies (civic organizations)

SECTION 7. PHASE-OUT OF COMMERCIAL BB


● 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 (2) years by the Secretary

SECTION 8. NON-PROFIT ORGANIZATION


● 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 DOH which shall be limited to the necessary expenses entailed in
collecting and processing of blood

SECTION 10. IMPORTATION OF BLOOD BANK EQUIPMENT, BLOOD BAGS, AND REAGENTS
● Imported tax and duty-free by:
○ PNRC
○ Blood banks and hospitals participating in the National Voluntary Blood Services Program (NVBSP)
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MEDICAL TECHNOLOGY LAWS AND BIOETHICS


RA 7722: HIGHER EDUCATION ACT OF 1994

_________________________________________________________________________________________________

REPUBLIC ACT NO. 7722


AN ACT CREATING THE COMMISSION ON HIGHER EDUCATION, APPROPRIATING FUNDS THEREFOR AND FOR
OTHER PURPOSES

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

Section 1.​ Title.


This Act shall be known as the ​"Higher Education Act of 1994".

Section 2.​ Declaration of Policy.


The State shall protect, foster and promote the right of all citizens to ​affordable quality education at all levels and shall
take appropriate steps to ensure that ​education shall be accessible to all​. The State shall likewise ensure and protect
academic freedom and shall promote its exercise and observance for the ​continuing intellectual growth​, the
advancement of learning and research, the development of responsible and effective leadership, the education of
high-level and middle-level professionals, and the ​enrichment of our historical and cultural heritage​.

State-supported institutions of higher learning shall gear their programs to national, regional or local development plans.
Finally, all institutions of higher learning shall exemplify through their physical and natural surroundings the dignity and
beauty of, as well as their pride in the intellectual and scholarly life.

Section 3.​ Creation of the Commission on Higher Education.


In pursuance of the above mentioned 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.

Section 4.​ Composition of the Commission.


The Commission shall be composed of ​five (5) full-time members. During the transition period which begins upon
approval of this Act, the President may appoint the Secretary of Education, Culture and Sports as ex officio chairman of
the Commission for a maximum period of one (1) year.

Thereafter, the President shall appoint a Chairman of the Commission and four (4) commissioners, who shall be holders
of earned doctorate(s), who have been actively engaged in higher education for at least ten (10) years, and must not have
been candidates for elective positions in the elections immediately preceding their appointment. They shall be
academicians known for their high degree of professionalism and integrity who have distinguished themselves as
authorities in their chosen fields of learning. The members of the Commission shall belong to different academic
specializations.

In no case shall any and all of the Commissioners appoint representatives to act on their behalf.

Section 5.​ Term of Office.


The President shall appoint the full-time chairman and the commissioners for a term of ​four (4) years​, without prejudice to
one reappointment. The terms of the initial appointees shall be on a staggered basis: the full-time chairman shall hold
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office for a term of four (4) years, the next two (2) commissioners for three (3) years, and the last two (2) commissioners
for two (2) years.

The commissioners shall hold office until their successors shall have been appointed and qualified. Should a member of
the Commission fail to complete his term, his successor shall be appointed by the President of the Philippines but only for
the unexpired portion of the term.

Section 6.​ Rank and Emoluments.


The chairman and the commissioners shall have the rank of a Department Secretary and Undersecretary, respectively.
They shall receive the compensation and other emoluments corresponding to those of a Department Secretary and
Undersecretary, respectively, and shall be subject to the same disqualifications.

Section 7.​ Board of Advisers.


There shall be constituted a Board of Advisers which shall meet with the Commission at least once a year to assist it in
aligning its policies and plans with the cultural, political and socioeconomic development needs of the nation and with the
demands of world-class scholarship.

The Board of Advisers shall be composed of the following:


1. the Secretary of Education, Culture and Sports, as chairman;
2. the Director-General of the National Economic and Development Authority, as co-chairman;
3. the Secretary of Science and Technology;
4. the Secretary of Trade and Industry;
5. the Secretary of Labor and Employment;
6. the President of the Federation of Accrediting Associations of the Philippines (FAAP); and
7. the President of the Fund for Assistance to Private Education (FAPE).

Two (2) additional members of the Board of Advisers may be appointed by the President upon recommendation of the
Commission.

Section 8.​ Powers and Functions of the Commission.


The Commission shall have the following powers and functions:
1. formulate and recommend ​development plans​, policies, priorities, and programs on higher education and
research;
2. formulate and recommend ​development plans​, policies, priorities and programs ​on research​;
3. recommend to the ​executive and legislative​ branches, priorities and grants on higher education and research;
4. set ​minimum standards for programs and institutions of higher learning recommended by panels of experts in
the field and subject to public hearing, and enforce the same;
5. monitor and ​evaluate the performance of programs and institutions of higher learning for appropriate incentives
as well as the ​imposition of sanctions such as, but not limited to, diminution or withdrawal of subsidy,
recommendation on the downgrading or withdrawal of accreditation, program termination or school closure;
6. identify, support and develop potential centers of excellence in program areas needed for the development of
world-class scholarship, nation building and national development;
7. recommend to the ​Department of Budget and Management the ​budgets of public institutions of higher learning
as well as general guidelines for the use of their income;
8. rationalize programs and institutions of higher learning and set standards, policies and guidelines for the creation
of new ones as well as the ​conversion or elevation of schools to institutions of higher learning, subject to
budgetary limitations and the number of institutions of higher learning in the province or region where creation,
conversion or elevation is sought to be made;
9. develop ​criteria for allocating additional resources ​such as research and program development grants,
scholarships, and other similar programs: Provided, That these shall not detract from the fiscal autonomy already
enjoyed by colleges and universities;
10. direct or ​redirect purposive research by institutions of higher learning to meet the needs of
agro-industrialization and developmen​t;
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11. devise and implement​ resource development schemes​;
12. administer the ​Higher Education Development Fund​, as described in Section 10 hereunder, which will promote
the purposes of higher education;
13. review the charters of institutions of higher learning and state universities and colleges including the
chairmanship and membership of their governing bodies and recommend appropriate measures as basis for
necessary action;
14. promulgate such rules and regulations and exercise such other powers and functions as may be necessary to
carry out effectively the purpose and objectives of this Act; and
15. perform such ​other functions as may be necessary for its effective operations and for the continued
enhancement, growth or development of higher education.

Section 9.​ The Secretariat.


The Commission shall organize a secretariat which shall be headed by ​an executive officer​, subject to the national
compensation and position classification plan. It shall fix the secretariat’s staffing pattern, determine the duties,
qualifications, responsibilities and functions, as well as the compensation scheme for the positions to be created upon the
recommendation of the executive officer. It shall also prepare and approve its budget.

The Commission shall appoint the members of the staff upon the recommendation of the executive officer.

Section 10.​ The Higher Education Development Fund.


A Higher Education Development Fund, hereinafter referred to as the Fund, is hereby established exclusively for the
strengthening of higher education in the entire country.

a. The Government’s contribution to the Fund shall be the following:


1. the amount of Five hundred million pesos (P500,000,000) as seed capital;
2. the amount of Fifty million pesos (P50,000,000) for the initial operation of the Commission;
3. the equivalent of forty percent (40%) annual share on the total gross collections of the travel tax;
4. the equivalent of thirty percent (30%) share of the collections from the Professional Registration Fee; and
5. the equivalent of one percent (1%) of the gross sales of the lotto operation of the Philippine Charity
Sweepstakes Office (PCSO).
b. Starting Fiscal Year 1995 and every year thereafter, government financing institutions identified and requested by
the Commission may contribute to the Fund an amount equivalent to not less than three percent (3%) but not
more than five percent (5%) of their unimpaired surplus realized during the immediately preceding year.
c. The Fund shall have a private portion to be raised from donations, gifts, and other conveyances including
materials, equipment, properties and services by gratuitous title.

Section 11.​ Management and Administration of the Higher Education Development Fund.
The Fund shall be administered by the Commission. For sound and judicious management of the Fund, the Commission
shall appoint a reputable government financial institution as portfolio manager of the Fund, subject to the following
conditions.

As administrator of the Fund, the Commission shall prepare the necessary guidelines for its use, subject to the following
conditions:
1. No part of the seed capital of the Fund, including earnings thereof, shall be used to underwrite overhead
expenses for administration;
2. Unless otherwise stipulated by the private donor, only earnings of private contributions shall be used for
administrative expenses;
3. The Commission shall appoint and organize a separate staff, independent administratively and budgetarily
separate from the Commission Secretariat; and
4. The Fund shall be utilized equitably according to regions and programs.
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Section 12. ​The Technical Panels.


The Commission shall reconstitute and/or organize technical panels for different disciplines/program areas. They shall
assist the Commission in setting standards and in program and institution monitoring and evaluation. The technical
panels shall be composed of senior specialists or academicians to be appointed by the Commission.

Section 13.​ Guarantee of Academic Freedom.


Nothing in this Act shall be construed as limiting the academic freedom of universities and colleges. In particular, no
abridgment of curricular freedom of the individual educational institutions by the Commission shall be made except for:
(a) minimum unit requirements for specific academic programs;
(b) general education distribution requirements as may be determined by the Commission; and
(c) specific professional subjects as may be stipulated by the various licensing entities.

No academic or curricular restriction shall be made upon private educational institutions which are not required for
chartered state colleges and universities.

Section 14.​ Accreditation.


The Commission shall provide incentives to institutions of higher learning, public and private, whose programs are
accredited or whose needs are for accreditation purposes.

Section 15. ​Tax Exemptions.


Any donation, contribution, bequest, and grant which may be made to the Commission shall constitute as allowable
deduction from the income of the donor for income tax purposes and shall be exempt from donor’s tax, subject to such
conditions as provided under the National Internal Revenue Code, as amended.

Section 16. ​Authority.


The Commission shall exercise such authority as may be deemed necessary within its premises or areas of operation to
effectively carry out its powers and functions and to attain its objectives: Provided, That the Commission may seek the
assistance of other government agencies for the proper implementation of this Act.

Section 17. ​Appropriation.


The amount of Five hundred million pesos (P500,000,000) is hereby authorized to be appropriated for the seed capital of
the Fund.

The additional amount of Fifty million pesos (P50,000,000) is hereby authorized to be appropriated out of the funds in the
National Treasury not otherwise appropriated or out of the Philippine Amusement and Gaming Corporation (PAGCOR)
funds for the initial operation of the Commission.

The sum equivalent to the appropriations for the current year for the Bureau of Higher Education and the
degree-granting-programs of the Bureau of Technical-Vocational Education, including those for higher and tertiary
education and degree granting vocational and technical programs of the Bureau of Technical-Vocational Education in the
regional offices, as well as parts of the budgetary items under the DECS budget that are concerned with higher and
tertiary education and degree-granting vocational and technical programs such as those for personal services,
maintenance and other operating expenses and capital outlay, shall be transferred to the Commission.

Thereafter, the funds necessary shall be included in the General Appropriations Act.

Section 18.​ Transitory Provisions.


Such personnel, properties, assets and liabilities, functions and responsibilities of the Bureau of Higher Education,
including those for higher and tertiary education and degree-granting vocational and technical programs in the regional
offices, under the Department of Education, Culture and Sports, and other government entities having functions similar to
those of the Commission are hereby transferred to the Commission.
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The Commission shall have the authority to appoint its own personnel.

All regular or permanent employees transferred to the Commission shall not suffer any loss of seniority or rank or
decrease in emoluments. Personnel of the Bureau of Higher Education not otherwise transferred to the Commission shall
be reassigned by the DECS in any of its offices and bureaus: Provided, however, That, any employee who cannot be
accommodated shall be given all the benefits as may be provided under existing laws, rules and regulations.

Jurisdiction over DECS-supervised or chartered state-supported post-secondary degree-granting vocational and technical
programs and tertiary institutions shall be transferred to the Commission.

A transitory body is hereby created which shall be composed of the Secretary of Education, Culture and Sports (DECS),
Chair of the Senate Committee on Education, Arts and Culture, Chair of the House Committee on Education and Culture,
a representative each of the Association of Christian Schools and Colleges (ACSC), the Catholic Educational Association
of the Philippines (CEAP), the Philippine Association of Colleges and Universities (PACU), the Philippine Association of
Private Schools, Colleges and Universities (PAPSCU), the Philippine Association of State Universities and Colleges
(PASUC), and the Philippine Association of Private Technical Institutions (PAPTI).

The transitory body shall facilitate the complete and full operation of the Commission which shall not be later than three
(3) months after the effectivity of this Act. It shall likewise, promulgate the rules and regulations necessary to effectively
implement the smooth and orderly transfer to the Commission. The transition period not exceeding three (3) months shall
commence from the approval of this Act.

Section 19. ​Repealing Clause.


All laws, presidential decrees, executive orders, rules and regulations or parts thereof which are inconsistent with the
provisions of this Act are hereby repealed or modified accordingly.

Section 20.​ Separability Clause.


If any part or provision of this Act shall be held unconstitutional or invalid, other provisions hereof which are not affected
thereby shall continue to be in full force and effect.

Section 21.​ Effectivity.


This Act shall take effect upon its approval.

Approved: 18 May 1994


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ADDITIONAL NOTES
COMMISSION ON HIGHER EDUCATION LOGO
● The ​CHED LOGO​ is a representation of how Philippine higher education evolved
● The ​pyramid​ represents the ideal three-level, manpower structure of the country, compromising of basic level
skills, middle or semi-skilled workers, and high or professional levels of human resource located at the apex of
the pyramid and the primary concern of higher education
● The​ human silhouette​ inside the pyramid represents human resources development of every Filipino to
become productive citizens of the country
● The ​rising sun​ symbolizes the dawning of a new era in higher education with the creation of CHED. CHED is
the prime mover in nation-building
● The ​sun’s rays​ signify the perpetual thirst for knowledge and expansion of learning throughout all the regions
of the country
● The ​color triad: red, yellow, and blue​ correspond to the colors of the Philippine flags as CHED was created to
be the main advocate and pillar of the nation building
● The ​year 1994​ indicated the year when CHED was created by law. On May 18, 1994, CHED was established
through Republic Act No. 7722, otherwise known as the “Higher Education Act of 1994”.

COMMISSION ON HIGHER EDUCATION


● Historical Background
○ The ​Commission on Higher Education (CHED) ​was created on May 18, 1994 through the passage of
Republic Act No. 7722, or the Higher Education Act of 1994. CHED, an attached agency to the Office
of the President for administrative purposes, is headed by a chairman and four commissioners, each
having a term of office of four years. The Commission ​En Banc​ acts as a collegial body in formulating
plans, policies and strategies relating to higher education and the operation of CHED.
○ The creation of CHED was part of a broad agenda of reforms on the country’s education system
outlined by the Congressional Commission on Education (EDCOM) in 1992. Part of the reforms was
the trifocalization of the education sector into three governing bodies: the CHED for tertiary and
graduate education, the Department of Education (DepEd) for basic education and the Technical
Education and Skills Development Authority (TESDA) for technical-vocational and middle-level
education.
● Mandate
○ Given the national government’s commitment to transformational leadership that puts education as the
central strategy for investing in the Filipino people, reducing poverty, and building national
competitiveness and pursuant to Republic Act 7722, CHED shall:
A. Promote relevant and quality higher education (i.e. higher education institutions and programs
are at par with international standards and graduates and professionals are highly competent
and recognized in the international arena);
B. Ensure that quality higher education is accessible to all who seek it particularly those who may
not be able to afford it;
C. Guarantee and protect academic freedom for continuing intellectual growth, advancement of
learning and research, development of responsible and effective leadership, education of high
level professionals, and enrichment of historical and cultural heritages; and
D. Commit to moral ascendancy that eradicates corrupt practices, institutionalizes transparency
and accountability and encourages participatory governance in the Commission and the
sub-sector.
● Incumbent Officials of CHED:
○ Chairperson: Vacant
○ Officer-in-charge: Com. Prospero E. De Vera III
○ Commissioners
■ Prospero E. De Vera III, DPA
■ Lilian A. Delas Llagas, PHD
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■ Minella C. Alarcon, PHD
■ Ronald L. Adamat, PHD

REPUBLIC ACT NO. 7722


1. CMO 14 s 2006
● Policies, Standards and Guidelines for MT education
2. CMO 6 s 2008
● Guidelines for the accreditation of Clinical Laboratories Involved in the training of MT/MLS Interns
3. CMO 13 s 2017
● Latest CMO for MT education (for K12 students)
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MEDICAL TECHNOLOGY LAWS AND BIOETHICS


RA 7170: ORGAN DONATION ACT OF 1991

_________________________________________________________________________________________________
REPUBLIC ACT NO. 7170
AN ACT AUTHORIZING THE LEGACY OR DONATION OF ALL OR PART OF A HUMAN BODY AFTER DEATH FOR
SPECIFIED PURPOSES

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled::

Section 1. ​Title.
This Act shall be known as the "Organ Donation Act of 1991".

Section 2. ​Definition of Terms.


As used in this Act the following terms shall mean:
A. "Organ Bank Storage Facility"
- a facility licensed, accredited or approved under the law for storage of human bodies or parts thereof.
B. "Decedent"
- a deceased individual, and includes a still-born infant or fetus.
C. "Testator"
- an individual who makes a legacy of all or part of his body.
D. "Donor"
- an individual authorized under this Act to donate all or part of the body of a decedent
E. "Hospital"
- a hospital licensed, accredited or approval under the law, and includes, a hospital operated by the
Government.
F. "Part"
- includes transplantable organs, tissues, eyes, bones, arteries, blood, other fluids and other portions of the
human body.
G. "Person"
- an individual, corporation, estate, trust, partnership, association, the Government or any of its
subdivisions, agencies or instrumentalities, including government-owned or -controlled corporations; or
any other legal entity.
H. "Physician" or "Surgeon"
- a physician or surgeon licensed or authorized to practice medicine under the laws of the Republic of the
Philippines.
I. "Immediate Family" of the decedent
- the persons enumerated in Section 4(a) of this Act.
J. "Death"
- the irreversible cessation of circulatory and respiratory functions or the irreversible cessation of all functions of the
entire brain, including the brain stem. A person shall be medically and legally dead if either

(1) In the opinion of the attending physician, based on the acceptable standards of medical practice, there is an
absence of natural respiratory and cardiac functions and, attempts at resuscitation would not be successful in
restoring those functions. In this case, death shall be deemed to have occurred at the time these functions
ceased; or
(2) In the opinion of the consulting physician, concurred in by the attending physician, that on the basis of acceptable
standards of medical practice, there is an irreversible cessation of all brain functions; and considering the absence
of such functions, further attempts at resuscitation or continued supportive maintenance would not be successful
in resorting such natural functions. In this case, death shall be deemed to have occurred at the time when these
conditions first appeared.
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The death of the person shall be determined in accordance with the acceptable standards of medical practice and shall be
diagnosed separately by the attending physician and another consulting physician, both of whom must be appropriately
qualified and suitably experienced in the care of such parties. The death shall be recorded in the patient's medical record.

Section 3. ​Person Who May Execute A Legacy.


– Any individual, at least eighteen (18) years of age and of sound mind, may give by way of legacy, to take effect after his
death, all or part of his body for any purpose specified in Section 6 hereof.

Section 4.​ Person Who May Execute a Donation.​ –


A. Any of the following, person, in the order of property stated hereunder, in the absence of actual notice of contrary
intentions by the decedent or actual notice of opposition by a member of the immediate family of the decedent,
may donate all or any part of the decedent's body for any purpose specified in Section 6 hereof:
a. Spouse;
b. Son or daughter of legal age;
c. Either parent;
d. Brother or sister of legal age; or
e. Guardian over the person of the decedent at the time of his death.
B. The persons authorized by sub-section (a) of this Section may make the donation after or immediately before
death.

Section 5.​ Examination of Human Body or Part Thereof .


A legacy of donation of all or part of a human body authorizes any examination necessary to assure medical acceptability
of the legacy or donation for the purpose(s) intended.

For purposes of this Act, an autopsy shall be conducted on the cadaver of accident, trauma, or other medico-legal cases
immediately after the pronouncement of death, to determine qualified and healthy human organs for transplantation
and/or in furtherance of medical science.

Section 6. ​Persons Who May Become Legatees or Donees.


The following persons may become legatees or donees of human bodies or parts thereof for any of the purposes stated
hereunder:
A. Any hospital, physician or surgeon
- For medical or dental education, research, advancement of medical or dental science, therapy or
transplantation;
B. Any accredited medical or dental school, college or university
- For education, research, advancement of medical or dental science, or therapy;
C. Any organ bank storage facility
- For medical or dental education, research, therapy, or transplantation; and
D. Any specified individual
- For therapy or transplantation needed by him.

Section 7.​ Duty of Hospitals.


A hospital authorized to receive organ donations or to conduct transplantation shall train qualified personnel and their staff
to handle the task of introducing the organ donation program in a humane and delicate manner to the relatives of the
donor-decedent enumerated in Section 4 hereof. The hospital shall accomplish the necessary form or document as proof
of compliance with the above requirement.
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Section 8. ​Manner of Executing a Legacy.
A. Legacy of all or part of the human body under Section 3 hereof may be made by will. The legacy becomes
effective upon the death of the testator without waiting for probate of the will. If the will is not probated, or if it is
declared invalid for testamentary purposes, the legacy, to the extent that it was executed in good faith, is
nevertheless valid and effective.
B. A legacy of all or part of the human body under Section 3 hereof may also be made in any document other than a
will. The legacy becomes effective upon death of the testator and shall be respected by and binding upon his
executor or administrator, heirs, assigns, successors-in-interest and all members of the family. The document,
which may be a card or any paper designed to be carried on a person, must be signed by the testator in the
presence of two witnesses who must sign the document in his presence. If the testator cannot sign, the document
may be signed for him at his discretion and in his presence, in the presence of two witnesses who must, likewise,
sign the document in the presence of the testator. Delivery of the document of legacy during the testator's lifetime
is not necessary to make the legacy valid.
C. The legacy may be made to a specified legatee or without specifying a legatee. If the legacy is made to a
specified legatee who is not available at the time and place of the testator's death, the attending physician or
surgeon, in the absence of any expressed indication that the testator desired otherwise, may accept the legacy as
legatee. If the legacy does not specify a legatee, the legacy may be accepted by the attending physician or
surgeon as legatee upon or following the testator's death. The physician who becomes a legatee under this
subsection shall not participate in the procedures for removing or transplanting a part or parts of the body of the
decedent.
D. The testator may designate in his will, card or other document, the surgeon or physician who will carry out the
appropriate procedures. In the absence of a designation, or if the designee is not available, the legatee or other
persons authorized to accept the legacy may authorize any surgeon or physician for the purpose.

Section 9.​ Manner of Executing a Donation.


Any donation by a person authorized under subsection (a) of Section 4 hereof shall be sufficient if it complies with the
formalities of a donation of a movable property.

In the absence of any of the persons specified under Section 4 hereof and in the absence of any document of organ
donation, the physician in charge of the patient, the head of the hospital or a designated officer of the hospital who has
custody of the body of the deceased classified as accident, trauma, or other medico-legal cases, may authorize in a public
document the removal from such body for the purpose of transplantation of the organ to the body of a living person:
Provided, That the physician, head of hospital or officer designated by the hospital for this purpose has exerted
reasonable efforts, within forty-eight (48) hours, to locate the nearest relative listed in Section 4 hereof or guardian of the
decedent at the time of death.

In all donations, the death of a person from whose body an organ will be removed after his death for the purpose of
transplantation to a living person, shall be diagnosed separately and certified by two (2) qualified physicians neither of
whom should be:
1. A member of the team of medical practitioners who will effect the removal of the organ from the body; nor
2. The physician attending to the receipt of the organ to be removed; nor
3. The head of hospital or the designated officer authorizing the removal of the organ.

Section 10.​ Person(s) Authorized to Remove Transplantable Organs.


Only authorized medical practitioners in a hospital shall remove and/or transplant any organ which is authorized to be
removed and/or transplanted pursuant to Section 5 hereof.

Section 11.​ Delivery of Document of Legacy or Donation.


If the legacy or donation is made to a specified legatee or donee, the will, card or other document, or an executed copy
thereof, may be delivered by the testator or donor, or is authorized representative, to the legatee or donee to expedite the
appropriate procedures immediately after death. The will, card or other document, or an executed copy thereof, may be
deposited in any hospital or organ bank storage facility that accepts it for safekeeping or for facilitation or procedures after
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death. On the request of any interested party upon or after the testator's death, the person in possession shall produce
the document of legacy or donation for verification.

Section 12.​ Amendment or Revocation of Legacy or Donation. –


A. If he will, card or other document, or an executed copy thereof, has been delivered to a specific legatee or donee,
the testator or donor may amend or revoke the legacy or donation either by:
a. The execution and delivery to the legatee or donee of a signed statement to that effect; or
b. An oral statement to that effect made in the presence of two other persons and communicated to the
legatee or donee; or
c. A statement to that effect during a terminal illness or injury addressed to an attending physician and
communicated to the legatee or donee; or
d. A signed card or document to that effect found on the person or effects of the testator or donor.
B. Any will, card or other document, or an executed copy thereof, which has not been delivered to the legatee or
donee may be revoked by the testator or donor in the manner provided in subsection (a) of this Section or by
destruction, cancellation or mutilation of the document and all executed copies thereof.

Any legacy made by a will may also be amended or revoked in the manner provided for amendment or revocation of wills,
or as provided in subsection (a) of this Section.

Section 13. ​Rights and Duties After Death.


A. The legatee or donee may accept or reject the legacy or donation as the case may be. If the legacy of donation is
of a part of the body, the legatee or donee, upon the death of the testator and prior to embalming, shall effect the
removal of the part, avoiding unnecessary mutilation. After removal of the part, custody of the remainder of the
body vests in the surviving spouse, next of kin or other persons under obligation to dispose of the body of the
decedent.
B. Any person who acts in good faith in accordance with the terms of this Act shall not be liable for damages in any
civil action or subject to prosecution in any criminal proceeding of this Act.

Section 14.​ International Sharing of Human Organs or Tissues.


Sharing of human organs or tissues shall be made only through exchange programs duly approved by the Department of
Health: Provided, That foreign organ or tissue bank storage facilities and similar establishments grant reciprocal rights to
their Philippine counterparts to draw organs or tissues at any time.

Section 15. ​Information Drive.


In order that the public will obtain the maximum benefits from this Act, the Department of Health, in cooperation with
institutions, such as the National Kidney Institute, civic and non-government health organizations and other health related
agencies, involved in the donation and transplantation of human organs, shall undertake a public information program.

The Secretary of Health shall endeavor to persuade all health professionals, both government and private, to make an
appeal for human organ donation.

Section 16.​ Rules and Regulations.


The Secretary of Health, after consultation with all health professionals, both government and private, and
non-government health organizations shall promulgate such rules and regulations as may be necessary or proper to
implement this Act.

Section 17. ​Repealing Clause.


All laws, decrees, ordinances, rules and regulations, executive or administrative orders, and other presidential issuance
inconsistent with this Act, are hereby repealed, amended or modified accordingly.

Section 18. ​Separability Clause.


The provisions of this Act are hereby deemed separable. If any provision hereof should be declared invalid or
unconstitutional, the remaining provisions shall remain in full force and effect.
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Section 19. ​Effectivity.
This Act shall take effect after fifteen (15) days following its publication in the Official Gazette or at least two (2)
newspapers of general circulation.

Approved: January 7, 1992


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MEDICAL TECHNOLOGY LAWS AND BIOETHICS
RA 9165: COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002

_________________________________________________________________________________________________

REPUBLIC ACT NO. 9165


AN ACT INSTITUTING THE COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002, REPEALING REPUBLIC ACT
NO. 6425, OTHERWISE KNOWN AS THE DANGEROUS DRUGS ACT OF 1972, AS AMENDED, PROVIDING FUNDS
THEREFORE, AND FOR OTHER PURPOSES

Be it enacted by the Senate and House of Representatives of the Philippines in Congress

RA 9165
● Comprehensive Dangerous Drugs Act of 2002
● June 7, 2002
● Repealing RA 6425, otherwise known as the Dangerous Drugs Act of 1972 (March 30, 1972)

DECLARATION OF POLICY
● It is the policy of the State to safeguard the integrity of its territory and the well-being of its citizenry particularly the
youth, from the harmful effects of dangerous drugs on their physical and mental well-being, and to defend the
same against acts or omissions detrimental to their development and preservation

ADMINISTER
1. Act of introducing any dangerous drug into the body of any person, with or without his/her knowledge, by injection,
inhalation, ingestion or other means, or of committing any act of indispensable assistance to a person in
administering a dangerous drug to himself/herself unless administered by a duly licensed practitioner for purposes
of medication

ANALYST
● Refers to the professional who perform the drug testing
● Certified Drug Analyst
○ Medical Technologist
○ Chemist
○ Chemical Engineer
○ Pharmacist

AUTHORIZED SPECIMEN COLLECTOR


● Person who is authorized to collect specimen from the client to secure and prevent alteration of urine specimen

CHAIN OF CUSTODY
● The procedure to account for each specimen bby tracking the handling and storage from point of collection to final
disposal. This procedure require that the applicant’s identity is confirmed and that a chain of custody from that is
used from the time of collection to receipt by the laboratory
● The form used to document the procedures from the time of collection until receipt by the laboratory

DANGEROUS DRUGS
● There are hundreds of dangerous drugs, but the most important and the most common tested in screening
laboratory is:
○ Methamphetamine (Shabu)
○ Tetrahydrocannabinol (Marijuana)
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● Other parameters that are tested includes:
○ Ecstasy
○ Opium
○ Cocaine

NATIONAL REFERENCE LABORATORY


● East Avenue Medical Center
○ National Reference Laboratory for environmental and occupational health, toxicology, and micronutrient
assay
● NRL
1. RITM
○ Dengue, influenza, TB and other Mycobacteria, Malaria and other parasites, Bacterial Enteric diseases,
measles, and other Viral exanthems, Mycology, Enterovirus, Antimicrobial resistance and emerging
diseases for confirmatory testing for blood donor units (HIV)
2. San Lazaro Hospital
○ HIV (Serological test), Hepatitis and other STD
3. National Kidney and Transplant Institute
○ Hematology including Immunohematology

SCREENING TEST
● A rapid test performed to establish potential/presumptive positive result
● Qualitative test

SPECIMEN
● Refers to the body fluid that is collected from a person

CLASSIFICATION OF DRUG TESTING LABORATORY


● Ownership
○ Government
○ Private
● Institutional Character
○ Institutional Based
○ Freestanding
● Service Capability
○ Screening Laboratory
○ Confirmatory Laboratory

MANDATORY DRUG TESTING


● Applicants for Driver’s License
● Applicants for Firearms License
● Officers and members of the military, police, and other law enforcements
● Candidates for Public Office
● Persons charged before the prosecutor’s office with criminal charge offense having an impossible penalty of
imprisonment of not less than 6 years and 1 day
● Persons apprehended for the violations of this act

RANDOM DRUG TESTING


● Students of Secondary or Tertiary schools
● Officers and employee of public and private offices whether domestic or overseas
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TECHNICAL REQUIREMENTS FOR LICENSING
● Physical Plant
1. Screening Laboratory
■ At least 20 sqm in floor area
■ The work area must be at least 10 sqm with exhaust fan, sink, and storage cabinet, and a ref
2. Confirmatory Laboratory
■ At least 60 sqm in floor area
■ The clinical work area must have at least 30 sqm 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 5 client at a time
● With hand washing facility, toilet facility, and a stall for the collection of the specimen
● Headship of the Laboratory
○ A licensed physician certified in Clinical Pathology by the Philippine Board Pathology
○ If not available, a licensed physician with training in Clinical Laboratory Management
○ In case when a laboratory is a division of the laboratory, licensed physician, chemist, medical
technologist, pharmacist, or a chemical engineer
○ A licensed chemist with at least Master’s Degree in Chemistry, Biochemistry, or branch of chemistry with
at least 2 years experience in analytical chemistry
● Personnel
1. Screening Laboratory
○ Shall have a full time Medical Technologist, Chemist, Pharmacist, and Chemical Engineer with
appropriate training in screening procedures for dangerous drugs
2. Confirmatory Laboratory
○ Shall have full time Medical Technologist, Chemist, Pharmacist, and Chemical Engineer who has
completed an extensive appropriate training in chromatography, spectroscopy. The analyst must pass the
proficiency test
● Laboratory Equipment
1. Screening Laboratory
○ Shall have a necessary equipment or kit
2. Confirmatory Laboratory
○ Shall have a necessary equipment for screening, qualitative and quantitative examination in addition to
the basic equipment
● Application Service Provider
○ The Laboratory shall have access to an Application Service Provider approved by the DOH for the
authentication of results
○ IDTOMIS — Integrated Drug Test Operations Management Information System

ACCREDITATION OF DRUG TESTING CENTERS AND PHYSICIANS


● DOH
○ License and accredit drug testing centers
○ Appoint technical and other personnel for effective implementation of this law
○ Accredit physicians who shall conduct the drug dependency exam and after care
○ Control of regulations, licensing, and accreditation division
○ Establish, operate and maintain drug testing centers in government hospitals
■ At least basic technologically advanced equipment and materials
○ Appoint qualified and duly trained technical and other personnel

TECHNICAL REQUIREMENT FOR ACCREDITATION


● Records
○ The laboratory shall maintain a record of all of its personnel. The records must include the resume,
training and experience, certification, PRC license, incident report (if any) and other information, which will
establish the competence of an employee
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● Security
○ The laboratory shall have security measures to control access to the premises to ensure that only
authorized personnel handle or have access to specimens or gain access to the lab
● Chain of Custody
○ The minimum required information on the Chain of Custody are:
1. Information identifying the specimen
2. Date and time of the specimen
3. Name of the testing laboratory
4. Name of the signatures of all individuals who had custody of the samples during the
collection process
● Storage of Laboratory Reports and Specimens
○ Report pertaining to specimens for laboratory report shall be kept by the testing laboratory for a minimum
period determined by DOH (1 year)
○ Specimens can be stored for:
■ Minimum of 5 days (negative)
■ 15 days (positive but not challenged)
■ 1 year
● Urine Specimen Collection, Handling and Disposal
○ The laboratory shall follow the DOH prescribed guidelines in the collection, handling and disposal of
specimens
○ Universal precautions must be observed at all times
■ Yellow – infectious waste such as gauze pad contaminated with urine specimen
■ Green – Biodegradable waste (food waste)
■ Black – Non-biodegradable waste (paper, office supply waste)
● Equipment and instruments
○ Screening Laboratory
■ Drug Testing Kits
○ Confirmatory Laboratory
■ Weighing scale
■ Glassware used in testing (beaker, Erlenmeyer flask, pipettes)
■ Automatic pipettes
■ Chromatographs
■ Spectrometer/ Mass Spectrometer
■ Biological Safety Cabinet
● Laboratory Report
○ Signatory must be the analyst who performed the test. And also the head of the laboratory
○ For screening, the test result must be reported and POSITIVE OR NEGATIVE
○ For Confirmatory, thve test results shall report the analyte and the concentration
○ 2 copies must be produced
■ 1 copy for the client
■ 1 copy must be forwarded to DOH and must include the membrane of the drug test kit
● Proficiency Testing
○ NRL shall conduct a continuing assessment of proficiency of the Screening and Confirmatory Laboratory
○ Participation of the laboratory is important and also must be satisfactorily passed the testing in order for
the laboratory to renew their license
○ The results must be sent back to NRL within 3 weeks after the results
○ Failure to pass the proficiency testing shall be given another chance, failure to pass the second one shall
result in revocation of its license and accreditation
● Drug Testing Result
○ Unlike pregnancy test result, a negative drug test result indicates a presence of line, and positive result is
an absence of line
● Validity of the Test Result
○ A drug certificate is valid for 1 year from the date of issue. Which may also be used for other purpose
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● Allowable Service Fee
○ Php 300 – Private Hospital/Free Standing Laboratory
○ Php 250 – Public Hospital

LICENSING AND ACCREDITATION


● The following must be submitted to DOH via BHFS before certificate of accreditation and license to operate is
given
○ License to Operate
■ BHFS application form
■ Mayor’s Permit
■ 1 set of floor plan
■ List of personnel, List of credentials, health certificate
■ List of Equipments
■ Contract of License (if facility is rented)
■ Copy of DOH license to operate
■ Documentation of CCF
■ Quality Control Program (Screening Laboratory)
■ Certification for Quality Control Standard System by a DOH recognized certifying body
(Confirmatory Laboratory)
■ Proficiency Testing Result
■ Procedure Testing Manual

CONTENT OF LICENSE TO OPERATE


● Name of the owner
● Head of the laboratory
● Procedures and Specialty
● Validity Report
● Signature of the Bureau or CHD Director

VALIDITY OF LTO
● Screening – 1 year
● Confirmatory – 2 years

RENEWAL OF LTO/COA
● It shall be filled 90 days before the expiration of license
● License to Operate
○ Application for renewal
○ Notarized List of Personnel
○ List of Equipments
○ Current Certificate of Accreditation
○ Current Mayor’s Permit
● Certificate of Accreditation
○ Current license to operate
○ Current Certification for Quality Standard System (Confirmatory Laboratory)

MONITORING OF LABORATORIES
● The bureau or the CHD may conduct a visit on the site (laboratory) unannounced. And the monitoring shall be
documented the overall quality of the laboratory setting

TERMS AND CONDITIONS OF LICENSING/ACCREDITATION


● License/ accreditation shall be granted in accordance with the prescribed requirement of the DOH
● A license/accreditation that is not renewed on the expiry date shall be considered lapsed and will be cancelled
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● Any change in management name or ownership, floor plan, reliever, equipment, etc shall be reported to the DOH
via BHFS
● License/Accreditation shall be placed in an area where it is seen by the client

VIOLATIONS
● Issuance of fraudulent result
● Failure to protect the confidentiality of a drug test result
● Failure to participate in a proficiency testing
● Failure to refer a positive result to a confirmatory laboratory
● Refusal to CHD to inspect their laboratory
● Any act which is contrary to the accepted clinical laboratory practice

ISSUANCE OF FALSE OR FRAUDULENT DRUG TEST RESULTS


● Any person authorized, licensed or accredited who issues false or fraudulent drug test results knowingly, willfully,
or through gross negligence
● Penalties
○ Imprisonment – 6 years and 1 day to 12 years AND
○ Fine – Php 100,000 to Php 500,000.
○ Additional Penalties – Revocation of license to practice/ closure of drug testing center

SUSPENSION OR REVOCATION OF LTO/COA


● Based on its own inspection of any complaint, it shall be investigated and after due hearing, and depending on the
judgement. Revocation or suspension of the license will be done
● If any violation is done (under Section 17) preventive suspension shall be done. And should not be more than 60
days

REAPPLICATION FOR LTO/COA


● 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

LABORATORY EXAMINATION OR TEST ON APPREHEND/ARRESTED OFFENDERS


● Any person apprehended or arrested for violating the provisions of this act shall be subjected to screening
laboratory examination within 24 hours
● If found positive, the results of the screening laboratory exam shall be challenged within 15 days after the receipt
of the results through a confirmatory test in any accredited laboratory
○ Gas chromatography/Mass spectrometry – confirmatory; GOLD STANDARD
○ Liquid chromatography/Mass spectrometry – PLATINUM STANDARD

REPUBLIC ACT NO. 9165


● January 23, 2002
● 102 Sections
● President of the Senate – Franklin M. Drilon
● Secretary of Health – Manuel M. Dayrit
● Speaker of the House of Representatives – Jose De Venecia, JR.
● President of the Philippines – Gloria Macapagal-Arroyo
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MEDICAL TECHNOLOGY LAWS AND BIOETHICS
RA 9288: NEWBORN SCREENING ACT OF 2004

_________________________________________________________________________________________________

REPUBLIC ACT NO. 9288


AN ACT PROMULGATING A COMPREHENSIVE POLICY AND A NATIONAL SYSTEM FOR ENSURING NEWBORN
SCREENING

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

ARTICLE 1
GENERAL PROVISIONS

SECTION 1.​ Short Title.


This Act shall be known as the "Newborn Screening Act of 2004."

SEC. 2.​ Declaration of Policy.


It is the policy of the State to protect and promote the right to health of the people, including the rights of children to
survival and full and healthy development as normal individuals. In pursuit of such policy, the State shall institutionalize a
national newborn screening system that is comprehensive, integrative and sustainable, and will facilitate collaboration
among government and non-government agencies at the national and local levels, the private sector, families and
communities, professional health organizations, academic institutions, and non-governmental organizations. The National
Newborn Screening System shall ensure that every baby born in the Philippines is offered the opportunity to undergo
newborn screening and thus be spared from heritable conditions that can lead to mental retardation and death if
undetected and untreated.
● Protect and promote the right to health of the people
● Rights of children to survival and full and healthy development as normal individuals
● Institutionalize a national newborn screening system

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.

● Access to newborn screening


● Establish and integrate a sustainable newborn screening system
● For health practitioners
○ Awareness of the advantages of NBS and their responsibilities
● For parents
○ Responsible parenthood
○ Child’s right to health and full development
○ Child protection from preventable causes of disability and death
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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 of 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 f​ acility 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 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.
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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).
● Obligation of health workers to inform parents or legal guardians of the newborn about newborn screening

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 (ICU) 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 s​hall 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 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 material 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
IMPLEMENTATION

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​:


● Chairperson: Secretary of Health
2) ​Develop the implementing rules and regulations for the immediate ​implementation of a nationwide newborn
screening program within one hundred eight (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​.
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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 National Screening Centers and recommend
corrective measures as deemed necessary.

The Committee shall be composed of eight (8) members, including the Secretary of Health who shall act as
Chairman. The other members of the Committee shall be as follows: (i) the Executive Director of the NIH, who
shall act as Vice Chairperson; (ii) an Undersecretary of the DILG; (iii) the Executive Director of the Council for the
Welfare of Children (iv) the Director of the Newborn Screening Reference Center; and (v) three (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. The three (3) representatives shall be appointed for a
term of three (3) years, subject to their being reappointed for additional three (3) years period 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 for any and all of the heritable conditions; (iii) ​be supervised and staffed
by trained personnel who have been duly qualified by the NIH​; and (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 the 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 within 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.
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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.

ARTICLE 5
FINAL PROVISIONS

SEC. 17. ​Repealing Clause.


- All general and special laws, decrees, executive orders, proclamations and administrative regulations, or any parts
thereof, which are inconsistent with this Act are hereby repealed or modified accordingly.

SEC. 18.​ Separability.


- If, for any reason or reasons, any party of provisions of this Act shall be declared or held to be unconstitutional or invalid,
other provision or provisions hereof which are not affected thereby shall continue to be in full force and effect.

SEC. 19. ​Effectivity.


- This Act shall take effect fifteen (15) days after its publication in at least two (2) newspapers of general circulation.

Approved,

FRANKLIN DRILON JOSE DE VENECIA JR.


President of the Senate Speaker of the House of Representatives

This Act which is consolidation of Senate No. 2707 and House Bill No. 6625 was finally passed by the Senate and the
House of Representatives on February 2, 2004 and February 5, 2004, respectively

OSCAR G. YABES ROBERTO P. NAZARENO


Secretary of Senate Secretary General
House of Representatives

GLORIA MACAPAGAL-ARROYO
President of the Philippines

Approved: April 07, 2004


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ADDITIONAL NOTES
INTRODUCTION
● Newborn Screening is a simple procedure to determine whether a baby has congenital metabolic disorder that
may lead to mental retardation and even death if left untreated
● Enactment of the law: April 6, 2004
● Implementing rules and regulations (IRR): October 5, 2014
● Newborn screening is done on the 48 hours or at least 2 hours from birth
● The baby must be screened again after 2 weeks for more accurate result
● A physician, medical technologist, nurse, a midwife can collect sample for newborn screening
● A few drops of blood are obtained from the baby’s heel and blotted on a special absorbent filter card

HISTORY OF THE NEWBORN SCREENING IN THE PHILIPPINES


● 1996 — PPS/POGS 24 accredited hospitals Newborn Screening Group. Philippine Newborn Screening Project
● 1998 — G6PD was added to the list of disorders. Homocystinuria was deleted
● 1999 — the DOH included NBSP in the CHILD 2025 Program
● 2001 — DOH created the National Technical Working Group for the nationwide implementation of NBSO

DISORDERS INCLUDED
1. Congenital hypothyroidism (CH)
● Deficiency in the production of thyroid hormone
● Prevalence – 1:3,350
● Poor growth, mental retardation, deafness and neurological abnormalities
● Treatment: thyroxine
2. Congenital adrenal hyperplasia (CAH)
● Abnormalities in specific enzymes of the adrenal gland
● Lack of enzyme steroid 21-hydroxylase (90% of the cases)
● Prevalence – 1: 13,500
● Vomiting and severe dehydration
○ Aldosterone deficiency, salt- wasting CAH
● Ambiguous genitalia in infants
3. Galactosemia (GA)
● Primary form is a deficiency of GALT (galactose-1-phosphate uridyl transferase: breaks down lactose)
● Prevalence – 1:60,000
● Galactosemia, mental retardation, and blindness
4. Phenylketonuria (PKU)
● Lack of phenylalanine hydroxylase
○ Converts Phe → Tyrosine
● Prevalence – 1:20,000
● Brain damage and mental retardation can occur
● Phenylalanine is present in almost all foods
5. Glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
● Function of G6PD
● Certain food and drug have oxidant properties that causes cell damage
○ Produce H​2​O​2​ and other reactive oxidizing products (OH​+​)
● Neutralize oxidative substances
● Without G6PD, RBC’s undergo hemolysis when exposed to oxidative stress
● Oxidative agents leading to hemolysis in G6PD deficiency
○ Drugs
■ Sulfonamides, quinolones, chloramphenicol, Vitamin K
○ Chemicals
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■ Mothballs
○ Food
■ Fava beans
○ Infection
● Clinical manifestations of G6PD Deficiency
○ Acute Hemolytic crisis
■ Anemia
■ Decreased oxygen delivery
■ Enlarged spleen
○ Increased bilirubin
■ Jaundice, tea colored urine
■ Accumulation in tissues
● Brain – kernicterus
● Gallbladder – gallstones

HOW IS NEWBORN SCREENING PERFORMED

SCREENING AND CONFIRMATORY TESTS

DISORDER SCREENING TEST CONFIRMATORY TEST

Congenital Adrenal Hyperplasia 17-OHP Inc. 17-OHP

Congenital Hypothyroidism TSH Dec. T4, Inc. TSH

Galactosemia Galactose Dec. GALT activity

Phenylketonuria Phenylalanine Dec. PAH activity

G6PD Deficiency G6PD Activity Dec. G6PD activity

NEWBORN SCREENING CENTERS


● NSC —Central Luzon
○ Angeles University Foundation Medical Center (2010)
● NSC — Southern Luzon
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○ Daniel Mercado Medical Center (2013)
● NSC — NOH
○ UP Manila (1997)
● NSC — Visayas
○ West Visayas State University Medical Center (2006)
● NSC — Mindanao
○ Southern Philippine Medical Center (2009)

* Recent addition (DOH Memo 2012-0__4) : MSUD


* Galactosemia : free
* Who pays for the confirmatory test? -- Parents
* Who pays for retesting of invalid specimens? -- Facility itself
* Basic testing fee for the 6 diseases: 550 (1,500 if expanded/including all 28 diseases)
* Specimen: capillary blood from the lateral part of heel (if median, will cause osteomyelitis)
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MEDICAL TECHNOLOGY LAWS AND BIOETHICS


PD 856, CHAPTER II: WATER SUPPLY

_________________________________________________________________________________________________

PRESIDENTIAL DECREE 856, CHAPTER II: WATER SUPPLY

Section 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.

Section 10.​ Jurisdiction of the Department

The approval of the Secretary or that of his duly authorized representative is required in the following cases:
1. Sites of water sources before their construction;
2. Delivery of water to consumers from new or recently repaired water systems;
3. Operation of a water system after an order of closure was issued by the Department;
4. Plans and specifications of water systems of subdivisions and projects prior to the construction of housing units
thereat; and
5. Certification of potability of drinking water.

Section 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
radio-active 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.

Section 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.

Section 13. ​Other Protective Measures


To protect drinking water from contamination, the following measures shall be observed:
1. Washing clothes or bathing within a radius of 25 meters from any well or other source of drinking water is
prohibited.
2. No artesians, deep or shallow well shall be constructed within 25 meters from any source of pollution.
3. 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 and safely enclosed by proper shielding.
4. 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 incharge of the public supply to which the connection is made and found to be safe and potable.
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5. The installation of booster pump to boost water direct from the water distribution line of a water supply system,
where low-water pressure prevails is prohibited.

ADDITIONAL NOTES
PD 856, CHAPTER II (CODE OF SANITATION)
● Section 1: Scope
○ All private and public water supply
DEFINITION OF TERMS
● Coliform organisms
○ Any rod-shaped, non-spore forming gram negative bacteria
○ Capable of growth in the presence of bile salts, or other surface-active agents
○ Ferment lactose at either 35-37°C within 24-48 hours
● Complete Treatment
○ A series or combination of water treatment processes
○ Coagulation, adsorption, sedimentation, slow and rapid sand filtration, aeration and chlorination
● Contamination
○ Introduction of materials not normally found in water
○ Make the water less desirable or unfit for its intended use
● Deep well
○ A well with depth greater than 20 meters constructed in areas
○ Aquifers or water-bearing formations generally located at a depth of more than 20 meters below ground
surface
● Disinfection
○ Water treatment process to destroy disease-causing organisms
○ Assessed by measuring the coliform group of indicator organism
● Most Probably Number (MPN)
○ A statistical method of determining microbial populations
○ A multiple dilution tube technique is utilized with a standard medium and observations are made for
specific individual tube effects
○ Resultant coding is translated by mathematical probability tables into population numbers
○ **pic
● Polluted Water
○ Water whose physical, chemical, bacteriological, biological, and radioactive properties have been
altered
○ Presence of domestic sewage, industrial waste or other substances in water that are possibly
objectionable or harmful to human lives
● Potable Water / Safe drinking water
○ Water that is free of microorganisms or disease-producing bacteria (pathogens)
○ In addition, the water should not possess undesirable taste, odor, color, levels of radioactivity, turbidity,
or chemicals and it should pass the standards set of the Philippine National Standards for Drinking
Water
● Reservoir
○ A pond, lake or basin, either natural or artificial designed for storage, regulation and control of water
● Water supplier
○ Any entity, government or private company, responsible for source development, water abstraction,
treatment and distribution of water
● Well
○ A man-made hole used for recovering groundwater from the water bearing strata **** boring, drilling or
by any other method
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CLASSIFICATION OF WATER SUPPLY FACILITIES (WATER SUPPLY-LEVEL OF SERVICE)


● Level 1 (Point Source)
○ A protected well or a developed spring with an outlet but without distribution system
○ Adaptable for rural areas where the houses are thinly scattered
○ Normally serves around 15 households
○ Access to water supply facilities
■ Farthest user not >250m from the point source
■ Generally for rural areas where houses are scattered too thinly to justify a distribution system
● Level 2 (Communal Faucet System or Standposts)
○ System composed of a source, a reservoir, a piped distribution network, and communal faucets
○ Access to water supply facilities
■ Farthest house is not >25m, from communal faucet system
○ 4 to 6 households per faucets
○ Generally rural areas where houses are clustered
○ Suitable for rural and urban fringe areas where houses are clustered densely to justify a simple piped
system
● Level 3 (Waterworks System or Individual Household Connection)
○ A system with a source, a reservoir, a piped distribution network and household taps
○ Suited for densely populated urban areas
○ Access to water supply facilities
■ The house has service connection from the system
■ One or more faucets per household
■ Generally for high -**** built-up areas

​PUBLIC OR PRIVATE WATER SUPPLY SYSTEM


● A government or private owned system for the provision *** potable water for human consumption
● The system includes
○ Any collection, treatment, storage and distribution facilities under the control of the operator of such
system and used primarily in connection thereto
○ Any collection, pretreatment, or storage facilities not under the control of the operator of the system
which are used primarily in connection with such system
○ Any water system that treats water on behalf of one or more public water systems for the purpose of
rendering it safe for human consumption

3.2 WATER TREATMENT


● Treatment is necessary so as to render water supply potable
● Depends on the quality of raw water
● Bacteriological quality shall be used as the main criterion
● No permit: shan’t be allowed to operate
● Classifying and evaluating raw-water quality
○ Group 1. Water Requiring Disinfection only
■ MPN of coliform organism not exceeding 50 per 100mL
○ Group 2. Water Requiring Complete Treatment
■ MPN of coliform 50 per 100mL to not more than 100 mL

3.3 WATER DISINFECTION


● Disinfection of water supply facilities shall be required for the following
○ Newly constructed water supply facilities
○ Water supply facility that has been repaired/improved
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○ All existing water facilities that exceeded the bacteriological value set by the Philippine National
Standards of Drinking Water
○ All water facilities that require continuous ***
○ Drinking water collected from doubtful source
● Disinfectant
○ Chlorine: main water disinfectant
○ Others may be used provided that it has residual effect
○ Responsible agencies/ persons for disinfection
● Requirements for complete chlorination of level I water supply facility
○ 50-100 ppm chlorine solution
○ The person who will conduct
■ Observes personal hygiene
■ Must be free from communicable disease
○ Procedures to follow on disinfection
■ Improved dug well
■ Drilled, driven and bored wells
■ Spring
■ Cistern
● Requirements for chlorination of level II and III water supplies
○ Appropriate chlorination equipment
○ Suitable gas mask or self-contained type breathing apparatus; small bottle of fresh ammonia solution –
to test for chlorine leakage
○ Separate building or room – for safety measures
○ Adequate ventilation
○ Free residual chlorine – 0.20 to 0.50 ppm until ** reaches the consumer and the farthest point in the
distribution system

5.1 STANDARD PARAMETERS AND VALUES FOR DRINKING WATER


● Philippine National Standards for Drinking Water
Sets criteria on standard parameters and values for bacteriological, physical, chemical, biological and radiological
quality

5.5 WATER DISINFECTION


● Requirements for household container disinfection
● Procedure to follow
○ Stock solution (only effective for 1 week)
■ 1 tsp of powder chlorine compounds (65-75%)
■ 1 liter of water
○ Add 2 tsp stock solution to 5 gallons (20L) of water
○ Mix thoroughly and let it stand for at least 30 seconds

*.* MONITORING SCHEME


● Local health community shall establish a Water Surveillance Program → Local Drinking Water Quality
Monitoring Committee
○ Oversee the operation of the water systems and the quality of water produced and distributed by them
and to monitor the implement of the IRR
● Shall be composed of
○ Municipal/City Health Authority – Chairman
○ Rural health unit/city health department
○ Water districts/ private water suppliers
○ Sangguniang panlalawigan/ panlungsod/ bayan
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○ Municipal/ City engineer’s office
○ DENR (CERNO)
○ NGO and Professional groups related to health and sanitation
○ DOH and representative to the local board
○ Provincial health office (provincial sanitation engineer)
● Functions of the committee
○ Regular collection and analysis of water samples
○ Evaluate lab results
○ Conduct survey during existence of a potential cause of contamination
○ Institute the public of drinking water quality
○ Performing other functions related to water quality assurance
A. Sites of water sources before their construction
B. Delivery of water to consumers from new or recently repaired water systems
C. Resumptions of the operation of water supply system
D. Plans and specifications of water systems of subdivision and project prior to the construction of housing units
thereat
E. Certification of the potability of drinking water
— No public water system shall be allowed to operate without Certificate of Portability
—Issued by the DOH secretary or duly authorized representative
—Issued after the required examinations are performed
—Required for drinking water
—Initial examination
● Physical, chemical and bacteriological exam of water from *****
—Periodic examination
● Bacteriological exam: as often as possible, interval shall not be longer than **
● General physicochemical exam: every 12 months or oftener
● Radioactive exam: yearly conducted
—Exam or samples shall of drinking water shall be performed only in laboratories which are duly licensed and
accredited the DOH
—To open a water analysis lab: apply to Bureau of Research and Laboratories - DOH through Regional Field
Health Office
—Imprisonment not exceeding 6 months
—Fine not exceeding Php 1,000
—Or both
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MEDICAL TECHNOLOGY LAWS AND BIOETHICS


REPUBLIC ACT NO. 11166: ​Philippine HIV and AIDS Policy Act

_________________________________________________________________________________________________

REPUBLIC ACT No. 11166

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

Be it enacted by the Senate and House of Representatives of the Philippine Congress Assembled:

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;
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(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 ineqaulity, marginalization, and ignorance.

Section 3.​ ​Definition of Terms.​ - For the purposes of this Act, the following terms shall be defines 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;
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(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 r​ efers 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;
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(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 r​ efers 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 refers 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 under going 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 r​ efers 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​ refersto 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 made or
female condoms. And reducing the number of sexual partners;
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(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 relecant 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;
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(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);


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(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 quor​ um 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.
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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, throughits 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.
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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 enhances 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.
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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
​ nd STI.
contain literature on the proper use of the prophylactic device or agent, and its efficacy against HIV​ a

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 requisute 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
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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 polcyand program for people whi 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 interventios. The DILG and DOH, in coordination with LGUs, shall etsablih 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:
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(a) A person volunteers or freely agrees to donate one's blood, organ, or tissue for transfusion, transplantation, or
reseach; 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";
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(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 tesing 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
PLHIVshall 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
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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 Harrassment. - 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.
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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 shalladopt 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
CONFIDENTIALITY

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
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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:
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(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. - Prohobition 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.1avvphi1

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,
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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
licences;

The permit or license of the business entity and the accreditation of the HIV testing centers may 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 that 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.1âwphi1

(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
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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, othewise 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
appropriationsfor 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
C. Lavin
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 know 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.

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Section 57. ​Effectivity. - This Act shall take effect fifteen (15) days after its complete publication in the ​Official Gazette o
in a newspaper of general circulation.

This Act which is a consolidation of Senate Bill No. 1390 and House Bill No. 6617 and the was passed by Senate and the
House of Representatives on October 10, 2018.

Approved: December 20, 2018

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