MEDICAL TECHNOLOGY LAWS AND BIOETHICS

RA 5527 AND ITS AMENDMENTS

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.
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 Health2 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.
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.
 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
 ■ 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;
 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
Histopathologic techniques, and that the scope of activities of said laboratories offer sufficient training in said laboratory
procedures.

SUMMARY
● Department of Health16 (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
 ● 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.
 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
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.
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
Commissioner24 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.
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 Service28 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
 ■ 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.

 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.
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;
 ● 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.
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,
 ● 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
 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.

 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
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
 ● 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
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
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 m2
Secondary– 20 m2
Tertiary– 60 m2

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
 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
 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 facility equipped with a newborn screening laboratory that complies with
the standards established by the NIH and provides all required laboratory tests and recall/follow-up programs for
newborns with heritable conditions.

10) Newborn Screening Reference Center means the central facility at the NIH that defines testing and follow-up
protocols, maintains an external laboratory proficiency testing program, oversees the national testing database
and case registries, assists in training activities in all aspects of the program, oversees content of educational materials
and acts as the Secretariat of the Advisory Committee on Newborn Screening.

11) Parent education means the various means of providing parents or legal guardians information about newborn
screening.

12) Recall means a procedure for locating a newborn with a possible heritable condition for purposes of providing the
newborn with appropriate laboratory to confirm the diagnosis and, as appropriate, provide treatment.

13) Treatment means the provision of prompt, appropriate and adequate medicine, medical, and surgical
management or dietary prescription to a newborn for purposes of treating or mitigating the adverse health
consequences of the heritable condition.
 ARTICLE 3
NEWBORN SCREENING
SEC. 5. Obligation to Inform. - Any health practitioner who delivers, or assists in the delivery, of a
newborn in the Philippines shall, prior to delivery, inform the parents or
legal guardian of the newborn of the availability, nature and benefits of
newborn screening. Appropriate notification and education regarding this
obligation shall be the responsibility of the Department of Health (DOH).
● 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 shall acknowledge in writing their understanding
that refusal for testing places their newborn at risk for undiagnosed
heritable conditions. A copy of this refusal documentation shall be
made part of the newborn's medical record and refusal shall be
indicated in the national newborn screening database.

SEC. 8. Continuing Education, Re-education and Training 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.

A
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4
 IMPLEMENTATIO

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.
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.
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

 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 H2O2 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
 ■ 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
 ○ 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)