Medical Technology Laws and Bioethics

Republic Act No. 5527

An Act Requiring the Registration of Medical Technologist, Defining
Their Practice, and for Other Purposes

(Approved: June 21, 1969)

Provisions of R.A. 5527 as Amended
Section 1. Title.
Section 2. Definition of Terms.
Section 3. Council of Medical Technology Education, Its Composition.
Section 4. Compensation and Traveling Expenses of Council Members.
Section 5. Functions of the Council of Medical Technology Education.
Section 6. Minimum Required Course.
Section 7. Medical Technology Board.
Section 8. Qualifications of Examiners.
Section 9. Executive Officer of the Board.
Section 10. Compensation of Members of the Board of Examiners for Medical Technology.
Section 11. Functions and Duties of the Board.-
Section 12. Removal of Board Members
Section 13. Accreditation of Schools of Medical Technology and of Training Laboratories.
Section 14. Inhibition Against the Practice of Medical Technology.
Section 15. Examination
Section 16. Qualification for Examination.
Section 17. Scope of Examination.
Section 18. Report of Rating.
Section 19. Rating in the Examination.
Section 20. Oath Taking.
Section 21. Issuance of Certificate of Registration
Section 22. Fees.
Section 23. Refusal to issue Certificate.
Section 24. Administrative Investigation.
Section 25. Appeal
Section 26. Reinstatement, Reissue or Replacement of Certificate
Section 27. Foreign Reciprocity
Section 28. Roster of Medical Technologist.
Section 29. Penal Provisions.
Section 30. Separability Clause.
Section 31. Repealing Clause.
Section 32. Effectivity

Express Amendments:
● R.A. 6138 (August 31, 1970)
○ Secs. 16, 21 & 22
● P.D. 498 (June 28, 1974)
○ Secs. 2, 3, 4, 7,8,11,13,16,17,21 & 29
● P.D. 1534 (June 11, 1978)
○ Secs. 3, 8, 11 & 13

Implied Amendments:
● R.A. 7722
● R.A. 8981
 An Act Requiring the Registration of Medical Technologist, Defining Their Practice, and for Other Purposes

(Approved: June 21, 1969)

Section 1. Title.- This Act may be also cited as the “Philippine Medical Technology Act of 1969.”

Section 2. Definition of Terms.- 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;
2. Blood banking procedures and techniques;
3. Parasitologic, Mycologic and Microbiologic procedures and techniques;
4. Histopathologic and Cytotechnology;
5. Clinical research;
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; and
8. Collection and preservation of specimens.

● Question: Med. Tech. “A” received a laboratory request from Dr. Strange for complete blood count (CBC). Med.
Tech. “A” immediately proceeded to the patient’s room, and withdrew a blood specimen. Then, he processed
the blood for the test requested. Do you consider the activity of Med. Tech. “A” as a professional service of
med. tech. profession?
● Answer: Yes. CBC is a hematologic procedure. Hematologic procedure and collection of blood specimens are
among the enumerated professional services of the medical technology profession. (see paragraphs 1 and 8)

● Question: Med. Tech. “A” prepared a 10% formalin by mixing nine parts of distilled water and one part of
aqueous formaldehyde. Thereafter, Med. Tech. “A” sold the 10%formalin solution to another laboratory. Do you
consider the activity of Med. Tech. “A” as a professional service of med. tech. profession?
● Answer: No. In order to consider the activity of Med. Tech. “A” within the contemplation of professional service
of med. tech. profession, the 10% formalin must be for the exclusive use of their laboratory. (see paragraph 6)

● Question: Med. Tech. “A” released the HIV result. Upon release, Med. Tech. “A” interpreted the laboratory
result to the patient in reference to his signs and symptoms. Med. Tech. “A” even prescribed a retroviral drug to
control the patient's viral load. Do you consider the activity of Med. Tech. “A” as a professional service of med.
tech. profession?
● Answer: No. Interpretation of laboratory results and prescription of drugs are not among the enumerated
professional services of the medical technology profession. (See paragraphs 1 to 8)

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.

There are three types of pathologists:

● Clinical pathologists
● Anatomic pathologists
● Molecular Pathologists
Note:
1. Sec. 29 (b)
2. Section 2 of R.A. 4688

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.

Section 3. Council of Medical Technology Education, Its Composition.- There is hereby established a Council of Medical
Technology Education, referred to as Council, which shall be composed of the Director of Higher Education as Chairman; the
Chairman of the Professional Regulation Commission as ViceChairman; and the Director of the Bureau of Research and
Laboratories of the Department of Health, 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.

• Composition of the Council of Medical Technology Education:

Chairman:Chairperson of the CHEd

Vice-chairman: Chairperson of the PRC

Members:
1. Director of the BRL (now HFSRB)
2. Chairman and two (2) members of the MTB
3. Representative of the PASMETH
4. President of the PSP: and
5. President of the PAMET.
Section 4. Compensation and Traveling Expenses of Council Members.

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

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

(CMO No. 13 Series of 2017)

● In order for a clinical laboratory to be considered as training laboratory the following must be present:
● The training laboratory must be a tertiary clinical laboratory;
● The clinical laboratory must be accredited with the HFSRB of the DOH; and
● The training laboratory must be accredited with the CHEd.

As a general rule, the internship program must be conducted in an accredited tertiary category institution-based Clinical
Laboratory.

As an exception, in areas where there is no or where there are limited number of tertiary category institution-based Clinical
Laboratories, affiliation of interns can be carried out in an accredited tertiary category free standing laboratory.

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.

Composition of Medical Technology Board - MTB (a.k.a. Professional Regulatory Board for Medical Technology PRB for
MT)
A. Chairman who is a pathologist; and
B. Two (2) members who are registered medical technologists Appointed by the President of the Republic of the
Philippines upon recommendation of the Professional Regulation Commission.

Term of Office: Three (3) years

In case of death, disability, or removal of a member of the Board, his successor shall serve only the balance of his term.

Example:
Question: Meng is the Chairman of MTB. He only served one (1) year because he died due to myocardial infarction. Lizzie, a
registered medical technologist, was appointed as Chairman of MTB by the Chairperson of PRC to serve for three (3) years. Is
the appointment valid?
A. No, the appointment is invalid because officers of MTB shall be appointed by the President of the Republic of the
Philippines, and not the Chairperson of the PRC.
B. No, the appointment is invalid because the newly appointed officer of MTB shall only serve the unexpired portion of his
predecessor, in this case, only two (2) years.
C. No, the appointment is invalid because the Chairman of MTB must be a qualified pathologist, not a medical technologist.
D. All of the above choices.

Section 8. Qualifications of Examiners.- No person shall be appointed as member of the Board of Examiners for Medical
Technology unless he or she is (1) is a Filipino citizen; (2) is of good moral character; (3) is a qualified Pathologist, or a duly
registered medical technologist of the Philippines with the degree of Bachelor of Science in Medical Technology/Bachelor of
Science in Hygiene/Public Health; (4) has been in practice of laboratory medicine or medical technology for at least ten years
prior to his appointment, and (5) is not a member of the faculty of any medical technology school for at least two years prior to
appointment or having any pecuniary interest direct or indirect in such institution: Provided, however, That for the first three
years following the approval of this Act, the requirements mentioned in number four (4) shall be reduced to five years.

Qualifications of MTB.
1) The or she is a Filipino citizen;
2) he or she is of good moral character;
3) he or she is a qualified Pathologist, or a duly registered medical technologist of the Philippines;
4) he or she has been in practice of laboratory medicine or medical technology for at least 10 years prior to his
appointment, and
5) he or she is not a member of the faculty of any medical technology school for at least two (2) years prior to
appointment or having any pecuniary interest direct or indirect in such institution.

Section 9. Executive Officer of the Board.

Section 10. Compensation of Members of the Board of Examiners for Medical Technology.

Section 11. Functions and Duties of the Board.- The Board is vested with authority and required, conformably with the
provisions of this Act, to:

● Administer the provisions of this Act;

● Administer oaths in connection with the administration of this Act;
● Issue, suspend and revoke certificates of registration for the practice of medical technology and medical
laboratory technician;
● Look into conditions affecting the practice of medical technology in the Philippines and, whenever necessary,
adopt such a measure may be deemed proper for the maintenance of good ethic and standards in the practice
of medical technology;
● Investigate such violations of this Act or of the rules and regulations issued thereunder as may come to the
knowledge of the Board and, for this purpose issue subpoena ad testificandum and subpoena duces tecum to
secure appearance of witnesses and production of documents in connection with charges presented to the
Board; and
● Draft such rules and regulations as may be necessary to carry out the provisions of this Act: Provided, that the
same shall be issued only after the approval of the President of the Philippines;
● To determine the adequacy of the technical staff of all clinical laboratories and blood before they could be
licensed with the Department of Health in accordance with R.A. No. 4655 and 1517;
● 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;
● 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.

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.

Requirements for removal of Board Members:

1. Removed by the President of the Philippines
2. Removed due to valid grounds (i.e. neglect of duty, incompetency, malpractice or unprofessional, unethical,
immoral or dishonorable conduct;) and
 3. There is an opportunity given to the erring board member to defend himself.

Provided that during the process of investigation, the President shall have the power to suspend such a member under
investigation and appoint a temporary member in his place. (Concept of Preventive Suspension)

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 Culture shall approve schools of Medical Technology in
accordance with the provisions of this Act, as amended, in conjunction with the Board of Medical Technology. The Department
of Health through the Bureau of Research and Laboratories shall approve laboratories for accreditation as training laboratories
for medical technology students or postgraduate trainees in conjunction with the Board of Medical Technology.

Accreditation of Schools of Medical Technology

❖ CHEd
Accreditation of Training Laboratories
❖ CHEd
❖ (Note: a clinical laboratory must first be accredited with the HFSRB (then BRL). If that clinical laboratory is
being utilized as a Training Laboratory, an additional accreditation with the CHEd is required.)

● In order for a clinical laboratory to be considered as training laboratory the following must be present:
● The training laboratory must be a tertiary clinical laboratory;
● The clinical laboratory must be accredited with the HFSRB of the DOH; and
● The training laboratory must be accredited with the CHEd.

Section 14. Inhibition Against the Practice of Medical Technology.- No person shall practice or offer to practice medical
technology as defined in this Act without having previously obtained a valid certificate of registration from the Board provided
that registration shall not be required of the following:
A. Duly registered physicians.
B. Medical technologists 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.

Inhibition Against the Practice of Medical Technology:

General rule: NO CERTIFICATE OF REGISTRATION, NO PRACTICE.
Exceptions:
A. Duly registered physicians.
B. Medical technologists from other countries called in for consultation or as visiting or exchange professors to
colleges or universities: Provided, they are only practicing the 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 saidACPBinarao forces only.

Section 15. Examination.- Except as otherwise specifically allowed under the provision of this Act, all applicants for registration
as medical technologist shall be required to undergo written examination.

(given twice a year)

At present, the board examination for medical technology is a written examination given twice a year, every March and
September. The testing areas include Manila, Baguio, Cagayan De Oro, Cebu, Davao, Iloilo, Tacloban, Tuguegarao and
Zamboanga. Written notices of such examination shall also 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.

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.)

Section 17. Scope of Examination.

➔ The examination questions shall cover the following subjects with their respective relative weights:
Clinical Chemistry ..................................................... 20%
Microbiology & Parasitology ..................................... 20%
Hematology ................................................................ 20%
Blood Banking & Serology ......................................... 20%
Clinical Microscopy (Urinalysis and other body fluids) ...................................……..…......... 10%
Histopathologic Techniques, Cytotechnology, Medical Technology Laws, Related Laws and its implementing rules, and the
Code of Ethics ........................………... 10%

Section 18. Report of Rating.- The Board shall, within one hundred and twenty (120) days after the date of completion of the
examination, report the result thereof to the Commissioner of Civil Service, who shall submit such result to the President of the
Philippines for approval.

(Impliedly modified by Section 9(h) of R.A. No. 8981)

Section 9(h) of R.A. No. 8981, otherwise known as “PRC Modernization Act of 2000,” provides for the functions of
Professional Regulatory Boards (PRBs):

(h) To prepare, adopt and issue the syllabi; determine and prepare the questions for the licensure examinations; score and rate
the examination papers; 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.
(Note: the PRB of Med. Tech. Profession is the MTB.)

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
examination will be given an applicant who has not qualified after three examinations, unless and until he shall have completed
12 months refresher course in an accredited medical technology school or 12-month postgraduate training 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.

• Note:
1. The candidate must obtain a general average of at least 75%;
2. No rating below 50% in any of the major subjects;
3. he candidate has not failed in at least 60% of the subjects computed according to their relative weights.
Student A failed the board examination for medical technology because he failed in Clinical Chemistry, Hematology, and Blood
Banking and Serology, which constitute at least 60% computed to their relative weights. (DQ)

Student B failed the board examination for medical technology because his rating in Hematology, a major subject, is below the
50% threshold. (DQ)

Student C failed the board examination because his general average is below the 75% passing rate.

Student D passed the board examination because he obtained a general average of at least 75%. He has no rating below 50%
in any of the major subjects, and he has not failed in at least 60% of the subjects computed according to their relative weights.

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
examination will be given an applicant who has not qualified after three examinations, unless and until he shall have completed
12 months refresher course in an accredited medical technology school or 12-month postgraduate training 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.

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 certificates shall be signed by the members
of the Board and by the Commissioner of the Professional Regulation Commission.

Provided, that upon application filed and the payment of the required fee of one hundred and fifteen pesos
(P 115.00) 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 has obtained a general rating of at least
70%. Provided, finally, that a registered medical laboratory technician when employed in the government shall
have the equivalent civil service eligibility not lower than second grade.

Section 22. Fees.

Section 23. Refusal to issue Certificate.- The Board shall refuse to issue a certificate of registration to any person convicted
by the court of competent jurisdiction of any criminal offense involving moral turpitude, or any person guilty of immoral or
dishonorable conduct, or of unsound mind, or incurable communicable disease, and in such shall be given to the applicant a
written statement setting forth the reason for its action, which statement shall be incorporated in the record of the Board.

Section 24. Administrative Investigation.- Revocation or Suspension of Certificates -Administrative investigation shall be
conducted by at least two members of the Board with one legal officer sitting during all administrative proceedings, the
respondents shall be entitled to be represented by counsel or be heard in person, to have a speedy and public hearing, to
confront and cross-examine witnesses against him or her, and to all other rights guaranteed by the Constitution. The Board
may, after giving proper notice and hearing to the party concerned reprimand an erring medical technologist or revoke or
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.

The following are the rules in imposing administrative penalties:

1. When Revocation is imposed, a unanimous vote of all the three members of the MTB is mandatory.
2. When Suspension or Reprimand is imposed, a majority vote of the members of the MTB will suffice.
3. When the penalty of Suspension is imposed, it shall not exceed two (2) years.
4. The period of Suspension shall run from the date of such surrender of certificate of registration.
 5. When the penalty of Suspension or Revocation is imposed, the med. tech. shall be required to surrender his
certificate of registration within thirty (30) days after the decision becomes final. The Med Tech. shall also
surrender his PRC Identification Card.
6. When the med. tech. fails to surrender his certificate of registration within 30 days from finality of the decision,
he shall be perpetually disqualified in practicing medical technology in the Philippines for inexcusable failure to
do so.

Section 25. Appeal.- The revocation or suspension of a certificate made by the Board shall be subject to appeal to the Civil
Service Commissioner whose decision shall become final thirty days after its promulgation, unless the respondent within the
same period has appealed to the office of the President of the Philippines.

(Impliedly amended by Section 9 (c) of RA 8981 )

Section 9 (c) of RA 8981 provides:

(c) To hear and investigate cases arising from violations of their respective laws, the rules and regulations promulgated
thereunder and their Codes of Ethics and, for this purpose, may issue summons, subpoena and subpoena duces tecum to
alleged violators and/or witnesses to compel their attendance in such investigations or hearings: Provided, That, the decision of
the Professional Regulatory Board shall, unless appealed to the Commission (PRC), become final and executory after fifteen
(15) days from receipt of notice of judgment or decision.

The decision of MTB to revoke or suspend a certificate of registration shall be appealed to?
a. CSC
b. CHED
c. PRC
d. DOH

The appeal from the decision of MTB revoking or suspending a certificate of registration shall be made within how many days?
a. 15 days
b. 30 days
c. 60 days
d. 120 days

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 President, furnished all Department Heads and all bureau, offices
and instrumentalities of the Department of Health and to such other offices, private or governmental, and to the public upon
request.

Section 29. Penal Provisions.- Without prejudice to the provision of the Medical Act of 1959 as amended relating to illegal
practice of Medicine, the following shall be punished by a fine of not less than two thousand pesos nor more than five thousand
pesos, or imprisonment for not less than six months nor more than two years, or both, in the discretion of the court:
 A. Any person who shall practice Medical Technology in the Philippines without being registered or exempted
from registration in accordance with the provisions of this Act;
B. Any medical technologist, even if duly registered, who shall practice medical technology in the Philippines
without the necessary supervision of a qualified pathologist or physician authorized by the Department of
Health;
C. Any medical technologist who shall knowingly make a fraudulent laboratory report;
D. Any duly registered medical technologist who shall refuse or fail, after due warning by the Board to display his
certificate of registration in the place where he works;
E. Any person presenting or attempting to use as his own, the certificate of registration of another;
F. Any person who shall give any false or fraudulent evidence of any kind to the Board or any member thereof in
obtaining a certificate of registration as Medical Technologist;
G. Any person who shall impersonate any registrant of like or the same name;
H. Any person who shall attempt to use a revoked or suspended certificate of registration;
I. Any person who shall in connection with his name or otherwise, assume, use or advertise any title or
description tending to convey the impression that he is a Medical Technologist without holding a valid
certificate of registration;
J. Any person or corporate body who shall allow anyone in his employ who is not a registered medical
technologist/medical laboratory technician to engage in the practice of medical technology or recommend for
appointment anyone to the position of medical technologist/medical laboratory technician knowing that he is
not registered as such.
K. Any person or corporate body who shall violate the rules and regulations of the Board or orders promulgated
by it after having been duly approved and issued by the President of the Philippines upon recommendation of
the Commissioner of Civil Service28 for the purpose of carrying out the provisions of this Act.

Section 30. Separability Clause.

Section 31. Repealing Clause.

Section 32. Effectivity.- This Act shall take effect upon its approval.

Approved, June 21, 1969.

REPUBLIC ACT NO. 10912

An Act Mandating and Strengthening the Continuing Professional Development Program for All Regulated
Professions, Creating Continuing Professional Development Council, and Appropriating Funds Therefor, and for
Other Related Purposes

July 21, 2016

Section Title.— This Act shall be known as the “Continuing Professional Development Act of 2016”.

This is the law that formally requires all professionals performing regulated professions under the PRC to mandatorily comply
with the CPD for the renewal of Professional identification Card (PIC). This is also the law that creates the CPD Council.

When was R.A. No. 10912 came into law?

● R.A. No. 10912 lapsed into law on July 21, 2016 and took effect on August 16, 2016 following its publication.
● It was however formally implemented by the PRC on March 15, 2017.
What is a CPD Council?
● CPD Council refers to a body created to promote and ensure the continuous improvement of professionals, in
accordance with national, regional and international standards of practice.

What is the composition of the CPD Council?

Every CPD Council shall be composed of a chairperson and two (2) members, and which shall be under the supervision of the
concerned PRB.

The chairperson of the CPD Council shall be the member of the PRB so chosen by the PRB concerned to sit in the CPD
Council. Term of office – Co-terminus

The first member shall be the president or officer of the AIPO/APO duly authorized by its Board of Governors/Trustees. xxx
Term of office – 2 years

The second member shall be the president or officer of the national organization of deans or department chairpersons of
schools, colleges or universities offering the course requiring the licensure examination. Xxx Term of office – 2 years

What is the nature of CPD?

● The CPD is a “MANDATORY REQUIREMENT” for renewal of the Professional Identification Cards (PIC) of all
registered and licensed professionals under the regulation of PRC, including Registered Medical Technologists
(RMTs) and Medical Laboratory technicians (MLTs).
● The CPD is mandatory for renewal of Professional Identification Card (PIC) per compliance period of three (3)
years.
● Generally, a maximum of one (1) CU per hour of activity may be given.
● Full credit units are given for attendance and completion of assessment.

Recognition of Credit Units

All duly validated and recognized CPD credit units earned by a professional shall be accumulated and transferred in
accordance with the Pathways and Equivalencies of the PQF.

R.A. No. 10968

An Act Institutionalizing the Philippine Qualifications Framework (PQF), Establishing the PQF-National Coordination
Council (NCC) And Appropriating Funds Thereof

Approved on: January 16, 2018

Section 1. Title – PQF Act

PQF objectives:
➔ to adopt national standards and levels of learning outcomes of education;
➔ to support the development and maintenance of pathways and equivalencies that enable access to
qualifications and to assist individuals to move easily and readily between the different education and training
sectors and between these sectors and the labor market; and
➔ to align domestic qualification standards with the international qualifications framework thereby enhancing
recognition of the value and comparability of Philippine qualifications and supporting the mobility of Filipino
students and workers.

The PQF is an eight (8)–level qualifications:

Level I : National Certificate I
Level II : National Certificate II
Level III : National Certificate III
Level IV : National Certificate IV
Level V : Diploma Level VI : Baccalaureate
Level VII : Post Baccalaureate
Level VIII : Doctoral/Post Doctoral

It is differentiated by descriptors of expected learning outcomes along the three domains:

1) knowledge, skills and values;
2) application; and
3) degree of independence.

REPUBLIC ACT NO. 4688

“An Act Regulating the Operation and the Maintenance of Clinical Laboratories and Requiring the Registration of the
same with the Department of Health, providing Penalty for Violation thereof, and for Other Purposes”

(Approved on June 18, 1966)

● Referred to as the “Clinical Laboratory Law”

● 8 sections
● Approved during the incumbency of Pres. Ferdinand Marcos

Sec.1 Any person, firm or corporation, maintaining or operating a clinical laboratory, 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 provisions of this section.

Sec.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.

Sec.3 The Secretary of Health, through the Bureau of Research and Laboratory (now known as the HFSRB), 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 provision.

Sec.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.

ADMINISTRATIVE ORDER NO. 2021-0037

(June 11, 2021)

New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines

Objective
• Ensures accurate, precise and reliable Lab results; and
• Lab. Results be released in a timely manner
Scope & Coverage
• Applies to all entities performing the activities and functions of clinical labs
• Excludes government hospital laboratories doing routine or minimum laboratory examinations

Classification of Laboratories (OFIS)

A. Classification by Ownership
•Government
• Private
B. Classification by Function
• Clinical Pathology
•Anatomic Pathology
•Molecular Pathology**
C. Classification by Institutional Character
•Institution-based
• Freestanding
D. Classification by Service Capability
1. L for Clinical & Anatomic Patho.
a. Primary
b. Secondary
c. Tertiary
d. Limited Service Capability
2. L for Anatomic Patho. only
- Cytology & Histopathology
3. L for Molecular Patho. only
- genetics, immune/hematopathology and infectious dse.

Other concepts:
1. National Reference Laboratory (NRL)** – the “highest level of laboratory” in the country National Reference Laboratory;
gov’t hospital lab designated by DOH and may or may not be a part of general clinical lab tasked for the ff: (CREST)
• Confirmatory testing;
• Resolution of conflicting results;
• Evaluation of diagnostic kits and reagents;
• Surveillance & facilitation of Nat’l External Quality Assessment Scheme (NEQAS)
• Training and research.

2. Mobile Clinical Laboratory (MCL) – moves from testing site but affiliated with main lab
• Mobile labs permitted to operate w/in 100 kms radius from main lab; and
• Shall be allowed to perform the following on-site tests:
• Urinalysis
• Fecalysis
• Preg. Test (lateral flow)
• Basis Serologic Test using Rapid Test Kits (Dengue, Screening for Hep. B, RPR/Syphilis Test and HIV)
• Note: Serum must be separated w/in 4 hrs

3. Physician’s Office Laboratory (POL) – refers to a doctor’s office/clinic wherein CL examinations are performed for the
purpose of monitoring the doctor’s patients only, wherein NO official results shall be issued. In this Order, POL within the
premises of a DOH-regulated facility shall be under the supervision of the CL.
Note: 1. Monitoring examinations only;
2. No official result is issued; and
3. Cater such doctor’s patients only.

4. Satellite Clinical Laboratory (SCL)

Features of SCL:
1. Extension of the main lab;
2. Located within the facility’s compound/premises; and
3. With the same service capability as the main lab

5. Point of Care Testing (POCT) — refers to diagnostic testing done at or near the site of patient care rather than in the CL. It
may be in the emergency room, operating suites, wards, and ambulances.

Ex: Random blood glucose, oxygen saturation, CT/BT, etc

License to Operate (LTO)

• Issued in the name of the applicant/licensee
• Issued after compliance with the minimum requirement
• Valid for 1 year
• non-transferrable
• Additional services (add-on services) must be reflected to the LTO, i.e. MCL, SLC, confirmatory testing for G6PD Def.,
rHIVda, etc.
• Arterial Blood Gas, Radioimmunoassay for thyroid function test and Prostate Specific Antigen shall be under CL.
• The HFSRB/CHD shall be informed for any substantial changes in the LTO

Certificate of Registration (COR)

• COR is required for research and teaching laboratories.
• Valid for 3 years
• COR for CL that is operated and maintained exclusively for research and teaching purposes shall be required to register with
the DOH-HFSRB every three (3) years.
• Note: CL that are operated and maintained exclusively for research and teaching purposes shall not issue official results for
diagnostic purposes.

Remote Collection Permit for Clinical Laboratory (RCP-CL)

• Issued only to CL that do not have MCL
• Valid only on the day of the activity
• Shall be secured w/in 7 days from intended remote collection
• The activity shall last from 4 to 6 hours
• The remote collection facility shall be w/in 100km from CL
• Only RMTs are allowed to collect blood samples/specimens
• Specimens for urinalysis/fecalysis must be stored at ref temp w/in 1 hr from time of collection
• Serum for blood chem must be separated within 4 hours from time of collection

Staffing
1. Pathologist/s
General Rule: ALL CL shall be headed by a Pathologist certified in Clinical Pathology.
Exception: For Tertiary CL with anatomic pathology, it shall be headed by a Pathologist certified in both Clinical and Anatomic
Pathology.
2. Med. Techs:
• At present, the number of laboratory professionals depend on the workload and working hours. The working hours vary from a
minimum of eight (8) hours to a maximum of twelve (12) hours. In so determining the number of laboratory professionals the
following guidelines must be observed:
• A single laboratory test is estimated to be processed within 10 minutes (10 minutes/test).
• Manual Testing: 50 tests/RMT/8 hours
• Manual Testing: 75 tests/RMT/12 hours
• Automated Testing: 100 tests/RMT/8 hours
• Automated Testing: 150 tests/RMT/12 hours
• Total number of staff include reliever/s
Information Management
Reporting
• Bear the name, PRC registration number & signature of Pathologist & RMT
• No report orally or in writing without directive from pathologist or associate except in emergency cases
• Note: Laboratories that are operated and maintained exclusively for research and teaching purposes shall not issue official
results for diagnostic purposes.

Recording
• All requests and reports of all specimens submitted and examined
• Confidential
• Kept in file for at least 1 year
• Anatomic and forensic pathology reports are kept permanently

Monitoring & Investigation of Charges or Complaints

• HFSRB/CHD Dir. or rep. shall investigate the complaint.
• HFSRB/CHD Dir or rep shall suspend, cancel or revoke & may seek any law enforcement agency to execute the closure of
any erring lab when necessary.
• CL with revoked license can only re-apply after 1 year from the date of LTO revocation.

Prohibited Acts:
1. Refusal to allow HFSRB/CHD to conduct inspection and monitoring visits
2. Refusal or non-participation in an EQAP
3. Absence of any action to improve unsatisfactory or failed EQAPD
4. Demonstrating incompetence or making consistent error in the performance of lab. proc./test.
5. Deviation from standard test procedure including use of expired rgts.
6. Issuance of lab reports w/o the authority of the Head of the Lab
7. Transferring of lab results done by another lab
8. Performing lab proc. beyond the authorized service capability.
9. Giving and receiving kickbacks, commissions, bonus or engaging in split-arrangement
10. Violation of the Data Privacy Act of 2012 (R.A. No. 10173)
Prohibited Acts that results in immediate revocation of LTO:
1. Permitting unauthorized or unregistered personnel to perform technical proc. or access lab. records/data
2. Lending or using the name of the CL or head of the lab or med tech to an unlicensed CL
3. Unauthorized to use the name and signature of the patho and rmt to secure LTO
4. Issuance of fraudulent lab results or tests not actually done or inaccurate results
5. Change in ownership, location, and head of lab or personnel without informing the HFSRB/CHD
6. 6. any material statement in the application of LTO

Appeal
• Head of Health Regulation Team (HRT) w/in 10 days after receipt of notice of decision. The decision of HRT may be further
appealed to the Sec. of Health w/in 10 days from receipt of notice of decision.
• Decision of Health Sec. is final & executory

July 17, 1948 PNRC - launched the National Blood Program

(President E. Quirino as the first Blood Donor.)
June 16, 1956 - R.A. 1517
May 5, 1994 - R.A. 7719
Second week of July - Blood Donor’s Week
1979 - AIDS was first described and identified.
1982 - First case of transfusion associated with AIDS was described in an infant.
1984 - First HIV infection in the Phil. was reported.

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”

(May 5, 1994)

• Title: “National Blood Services Act of 1994”.

• This Act shall supersede Republic Act No. 1517 entitled “Blood Bank Act.”

Mandates of R.A. No. 7719

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

Axioms provided under R.A. No. 7719:

1. Blood shall be collected from healthy voluntary donors only.
2. All commercial blood banks shall be phased-out.
3. All BSFs shall operate on a non-profit basis.
4. All BSFs shall be registered and issued a license to operate or authority to operate.
5. All BSFs shall be under the management of a licensed and qualified physician.(Pathologist/ Licensed
Physician w/3 month training)
6. Blood which has been proven contaminated with blood transfusion transmissible diseases shall be discarded
within 48 hours.
 Administrative Order. No. 2008-0008
Rules and Regulations Governing the Regulation of Blood Service Facilities
(May 02, 2008)

• This AO shall apply to all government and private BSF.

Classification of BSF:
1. Ownership (Govt./Private)
2. Institutional Character (Hosp./Non-Hosp. based)
3. Service Capability
a. Blood Station (BS)
i. Storage, issuance, transport & distribution of blood
b. Blood Collection Unit (BCU)
i. Collection of blood
c. BS-BCU
d. Blood Bank (BB)
e. Blood Centers
i. Testing units of TTIs
ii. All blood units screened by BCs shall not be retested for TTIs by the end-user hospitals.
1. If found infected with any of the TTIs, the blood unit must be discarded within 48
hours.

Note:
G.R.: Blood Units issued by the BCs shall not be re-tested for Transfusion – Transmitted Infections (TTIs).

Exp: HIV Test, a patient may demand a second test, as a matter of right. (Section 26(e) of R.A. No. 11166)

5 Core Tests (WHO)

1. HIV test
2. Serum Hepatitis (HbsAg)
3. Antibody to Hepatitis C
4. Test for Syphilis
5. Malaria
Note:
AUTHORITY TO OPERATE (ATO) LICENSE TO OPERATE (LTO)
G.R.: LTO/ATO is
Formal permit issued by the DOH thru Formal authority given by the DOH thru valid for 3 years.
HFSRB/CHD HFSRB/CHD Exp: if the
LTO/ATO issued to
To a BCU/BS To BB/BC BB/BCUBS is part
of hospital license,
the LTO/ATO is valid for 1 year.

Records
•All records in BB are kept permanently

Investigation
• The HFSRB and CHD, through its director or his authorized representative, is authorized to investigate complaints against
BSF or any of its personnel who violated R.A. No. 7719 and its implementing rules and regulations. It can impose the penalty of
reprimand, suspension or revocation of ATO/LTO.

Appeal
• For those complaints decided by the CHD/HFSRB, an aggrieved party may file an appeal to the Secretary of Health of the
DOH within 30 days from receipt of the decision. The decision of the Secretary of Health shall be final and executory.

REPUBLIC ACT No. 11166

“An Act Strengthening the Philippine Comprehensive Policy on Human Immunodeficiency Virus (HIV) and Acquired
Immune Deficiency Syndrome (AIDS) Prevention, Treatment, Care, and Support, and, Reconstituting the Philippine
National Aids Council (PNAC), Repealing for the Purpose Republic Act No. 8504, Otherwise Known as The "Philippine
Aids Prevention and Control Act of 1998", and Appropriating Funds Therefor”

(Approved on December 20, 2018)

• This Act shall be known as the "Philippine HIV and AIDS Policy Act".

R.A. No. 11166 is the law that:

1. Strengthens the Philippine Comprehensive Policy on Human Immunodeficiency Virus (HIV) and Acquired
Immune Deficiency Syndrome (AIDS) Prevention, Treatment, Care, and Support;
2. Reconstitutes the Philippine National Aids Council (PNAC);
3. Repeals Republic Act No. 8504; and
4. R.A. No. 11166 is also known as the "Philippine HIV and AIDS Policy Act," which was approved on December
20, 2018.

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.

HIV Testing refers to a procedure that is conducted to determine the presence or absence of HIV in a person's body. HIV
testing:
1. Confidential
2. Voluntary
3. Involves counseling
4. Informed consent

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.
● As a general rule, any person who is at least 15 years of age shall have the authority to give consent to take
HIV testing. (Evolving Capacities of the Child)
● Those persons below 15 years of age or mentally incapacitated, consent may be obtained from the child's
parents and legal guardian.
● As an exception, even if the person is below 15 years of age, the minor may still give consent to take HIV
testing provided that the minor is pregnant or engaged in high risk behavior, and duly assisted by a licensed
social worker or health worker. (Mature Minor Doctrine)

Classification of HIV Test as to the requirement of Consent:

Voluntary HIV testing - willingly submits to such test.

Compulsory HIV Testing - 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.

Instances of Compulsory HIV Testing:

A. When it is necessary to test a person who is charges with any of the offenses punishable under Articles 264
and 266 on serious and slight physical injuries, and Article 335 and 338 on rape and simple seduction, both of
Act No. 3815 or the "The Revised Penal Code", as amended, and as also amended by Republic Act. No. 8353,
otherwise known as "The Anti-Rape Law of 1997";
 B. When it is necessary to resolve relevant issues under Executive Order No. 209, otherwise known as "The
Family Code of the Philippines"; and
C. As a prerequisite in the donation of blood in compliance with the provisions of Republic Act No. 7170,
otherwise known as the "Organ Donation Act of 1991", and Republic Act No. 7719, otherwise known as the
"National Blood Services Act of 1994".

Classification of HIV Testing as to Phases:

1. Screening Test refers to the initial serologic test performed to determine the presence of antibodies against HIV
1 and HIV 2. This test includes but is not limited to Enzyme Immunoassay (EIA), Particle Agglutination Test
(PA), Rapid Immunoassays and other screening tests for HIV antibody.
2. Confirmatory Test refers to the test performed on samples reactive to the screening test to ensure that results
are true positive. This test includes but is not limited to Western Blot (WB), Line Immunoassay (LIA),
Immunofluorescence Assay (IF) and Polymerase Chain Reaction (PCR).

At present, the DOH recommends the use of a rapid HIV diagnostic algorithm (rHIVda) as the new confirmatory test in
the Philippines.

Issuance of Test Result:

The result of any test related to HIV shall be disclosed only to the individual who submitted to the test. If the patient is below
fifteen (15) years old, an orphan, or is mentally incapacitated, the result may be disclosed to either of the patient's parents,
legal guardian, or a duly assigned licensed social worker or health worker, whichever is applicable. If the patient is below fifteen
(15) years of age and not suffering from any mental incapacity, has given voluntary and informed consent to the procedure in
accordance with “Mature Minor Doctrine”, the result of the test shall be disclosed to the child.

Standard Precaution on the Donation of Blood, Tissue, or Organ.

1. All donated blood shall also be subjected to HIV testing;

2. Donation of tissue or organ shall be accepted by a laboratory or institution only after a sample from the donor
has been tested negative for HIV;
3. All donors whose blood, organ or tissue has been tested positive shall be deferred from donation;
4. Donations of blood, tissue, or organ tested positive for HIV may be accepted for research purposes only; and
5. 5. 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.

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.

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

1. When complying with reportorial requirements of the national active passive surveillance system of the DOH;
2. When informing other health workers directly involved in the treatment or care of a PLHIV; and
3. 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.

The Philippine National Aids Council

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

REPUBLIC ACT NO. 9165

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

(Approved: June 07, 2002)

• Short Title. – This Act shall be known and cited as the "Comprehensive Dangerous Drugs Act of 2002".
• The Whole law contains 102 sections

Possession of Dangerous Drugs

The penalty of life imprisonment to death and a fine ranging from Five hundred thousand pesos (P500,000.00) to Ten million
pesos (P10,000,000.00) shall be imposed upon any person, who, unless authorized by law, shall possess any dangerous drug
in the following quantities, regardless of the degree of purity thereof:
A. 10 grams or more of opium;
B. 10 grams or more of morphine;
C. 10 grams or more of heroin;
D. 10 grams or more of cocaine or cocaine hydrochloride;
E. 50 grams or more of methamphetamine hydrochloride or "shabu";
F. 10 grams or more of marijuana resin or marijuana resin oil;
G. 500 grams or more of marijuana
H. 10 grams or more of other dangerous drugs such as, but not limited to, methylenedioxymethamphetamine
(MDA) or "ecstasy", paramethoxyamphetamine (PMA), trimethoxyamphetamine (TMA), lysergic acid
diethylamine (LSD), gamma hydroxyamphetamine (GHB), and those similarly designed or newly introduced
drugs and their derivatives, without having any therapeutic value or if the quantity possessed is far beyond
therapeutic requirements.

Authorized Drug Testing

Authorized Drug Testing – authorized drug testing shall be done by any government forensic laboratories or by any of the
drug testing laboratories accredited and monitored by the DOH to safeguard the quality of test results. The DOH shall take
steps in setting the price of the drug test with DOH accredited drug testing centers to further reduce the cost of such drug tests.
The drug testing shall employ, among others, two (2) testing methods, the (1) screening test which will determine the positive
result as well as the type of the drug used and the (1) confirmatory test which will confirm a positive screening test. Drug test
certificates issued by accredited drug testing centers shall be valid for a one year period from the date of issue which may be
used for other purposes.

The following shall be subjected to undergo drug testing:

A. Applicants for driver's license
B. Applicants for firearm's license and for permit to carry firearms outside of residence
C. Students of secondary and tertiary schools
D. Officers and employees of public and private offices
E. Officers and members of the military, police and other law enforcement agencies
F. All persons charged before the prosecutor's office with a criminal offense having an imposable penalty of
imprisonment of not less than six (6) years and one (1) day shall have to undergo a mandatory drug test; and
G. All candidates for public office whether appointed or elected both in the national or local government shall
undergo a mandatory drug test.
H. Persons apprehended in violating RA 9165

Section 36 of RA 9165
The following persons need to undergo drug testing:
 REPUBLIC ACT No. 10586

AN ACT PENALIZING PERSONS DRIVING UNDER THE INFLUENCE OF ALCOHOL, DANGEROUS DRUGS, AND
SIMILAR SUBSTANCES, AND FOR OTHER PURPOSES

"Anti-Drunk and Drugged Driving Act of 2013″

Approved on MAY 27 2013

Repealed Section 36 (a) of R.A. No. 9165 effectively removing the requirement of DT to all applicants of Driver’s License.

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

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

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

Accreditation of Drug Testing Centers and Physicians – The DOH shall be tasked to license and accredited drug testing
centers in each province and city in order to assure their capacity, competence, integrity and stability to conduct the laboratory
examinations and tests provided in this Article, and appoint such technical and other personnel as may be necessary for the
effective implementation of this provision. The DOH shall also accredit physicians who shall conduct the drug dependency
examination of a drug dependent as well as the after-care and follow-up program for the said drug dependent. There shall be a
control regulations, licensing and accreditation division under the supervision of the DOH for this purpose.
For this purpose, the DOH shall establish, operate and maintain drug testing centers in government hospitals, which must be
provided at least with basic technologically advanced equipment and materials, in order to conduct the laboratory examination
and tests herein provided, and appoint such qualified and duly trained technical and other personnel as may be necessary for
the effective implementation of this provision.

DRUGS OF ABUSE

A. Amphetamines: Narcolepsy, Attentional deficit disorder

a. Amphetamine, Methamphetamine, Methylphenidate
b. Derivative of amphetamines: MDMA/ Ecstasy
B. Anabolic steroids: Increasing muscle mass (athletes)
C. Cannabinoids: Hallucinogen (THC); Induce Euphoria
a. Urine metabolite: 11-nor-Delta(9)-tetrahydrocannabinol-9-COOH
D. Cocaine (Crack): Local anasthetic for nasopharyngeal surgery
a. Urine metabolite: Benzoylecgonine
E. Opiates: Analgesia, Sedation & Anesthesia
a. Opium, Morphine, Codeine, Heroin
b. Major metabolites of Heroin: N-acetylmorphine & Morphine
F. Phencyclidine (Angel Dust or Angel Hair): Analgesia & Anesthesia
a. Major metabolite: Phencyclidine HCl
G. Sedative Hypnotics: CNS depressants (Barbiturates, Benzodiazepines)
a. Major metabolite: Secobarbital
H. Lysergic Acid Diethylamide: Hallucinogen
a. Panic reaction (Bad trip)
b. Major metabolite: 2-oxo-3-hydroxy LSD
I. Methaqualone (Quaalude): Hallucinogen
J. Piperazines : same with Amphetamines A E.g. TFMPP or Molly, BZP
K. tryptamines E.g. DMT (causes Businessman’s lunch), Psilocin l) Cathinones (Bath Salts):
Psychoactive designer drugs

BOARD REGULATION NO. 2 series of 2003

Subject:
IMPLEMENTING RULES AND REGULATIONS GOVERNING ACCREDITATION OF DRUG TESTING LABORATORIES IN
THE PHILIPPINES

Approved: June 27, 2003

DTL refers to a private or government facility that is capable of testing a specimen to determine the presence of dangerous
drugs therein.

• Classification of DTLs:
1. Ownership (Govt./Priv.)
2. Institutional Character (Inst.-based/Freestanding)
3. Service Capability
1. Screening Laboratory – a laboratory capable of performing screening tests.
2. Confirmatory Laboratory – a laboratory capable of performing qualitative and quantitative examinations of dangerous
drugs from the specimen.

Screening DTL Confirmatory DTL

For Freestanding Screening DTL, it shall be headed by: Shall be headed by:
 1. Pathologist; or 1. Pathologist; or
2. Licensed Physician with Clinical Laboratory Management 2. Chemist with Master’s Degree in Chemistry or
Training. Biochemistry.

For Institution-based Screening DTL, it shall be headed by:

1. Licensed Physician;
2. Chemist;
3. Medical Technologist;
4. Pharmacist; or
5. Chemical Engineer

There are 4 Professionals who can be a Certified Drug Analyst

1. Medical Technologist
2. Chemist
3. Chemical Engineer
4. Pharmacist

Physical Plant Floor Area Work Area

Screening Lab. 20 sqm 10 sqm

Confirmatory Lab. 60 sqm 30 sqm

Two phases of Drug Testing:
1. Screening
a. Immunoassay. The following are examples:
I. Enzyme Immunoassay (EIA)
II. Enzyme-multiplied immunoassay technique (EMIT)
III. Fluorescence polarization
IV. Radioimmunoassay (RIA)
b. Chromatography. The following are examples:
a. Thin Layer Chromatography (TLC)
b. Gas Chromatography (GC)
c. Liquid Chromatography (LC) (i.e. High Performance Liquid Chromatography or HPLC)
2. Confirmatory.
a. Hyphenated Technique. Combination of two sophisticated technologies (i.e. Gas Chromatography – Mass Spectrometry
or GC-MS) or other such modern and acceptable techniques (i.e. LC-MS, GC-MS-MS, or LC-MSMS).

The following SPECIMENS may be submitted for drug test: Urine, Blood, Fingernails, Saliva (Oral Fluid), Scalp Hair, Sweat
(Patch), and Tissue. If urine, 60mL (single collection) or 30mL/30mL (split collection)
Test result: Valid for 1 year from the date of issue.

The NRL for Drug Testing is the EAMC.

Certificate of Accreditation:
1. Confirmatory laboratory - valid for two (2) years.
2. Screening laboratory - valid for one (1) year.

Specimens with confirmed positive test results, which are not challenged within fifteen (15) days after receipt, shall be
discarded. A specimen may be kept for a maximum of one (1) year upon request. A minimum of 5 days for negative
specimens.

All test results shall bear the signature of the analyst and head of laboratory.
A screening test result shall be reported as negative or positive. A confirmatory test shall report the presence or absence and
the identity of the drug/metabolite tested as well as its concentration.

Drug Testing Result

Unlike pregnancy test results, a negative drug test result indicates a presence of line, and a positive result is an absence of
line.

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

The certificate of accreditation shall state on its face the name of the owner and head of the laboratory, the classification and
validity period. It shall be signed by the Bureau or CHD Director.

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

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

Application Service Provider

Connected to the DOH database via the internet. Every DTC must have an internet connection for every transaction made, the
result is sent to DOH, for recording.

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.

Republic Act No. 9288

“AN ACT PROMULGATING A COMPREHENSIVE POLICY AND A NATIONAL SYSTEM FOR ENSURING NEWBORN
SCREENING”
 (April 07, 2004)
•AKA: "Newborn Screening Act of 2004.“

What is Newborn Screening (NBS)?

● NBS 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. It is a simple
procedure to find out if a newborn has a congenital disorder that may lead to mental retardation or even death
if left untreated. (Section 4(8) of R.A. No. 9288)
● NBS is further defined as an essential public health strategy that enables the early detection and management
of several congenital disorders (metabolic and endocrine disorders, hemoglobinopathies, and cystic fibrosis),
which if left untreated, may lead to mental retardation, disability and/or even death. (DOH Administrative Order
No. 2018- 0025)

What is an “Expanded Newborn Screening”?

Expanded Newborn Screening (ENBS) is an examination that increases the coverage of NBS panels from 6 to 28+ falling
under various types of congenital disorders.

What are the various types of heritable or congenital disorders tested under ENBS?

The various types of disorders include:

1. Hemoglobinopathies;
2. Amino acid disorders;
3. Organic acidurias;
4. Disorder of fatty acid oxidations;
5. Disorder of carbohydrate metabolism;
6. Disorder of biotin metabolism;
7. Cystic fibrosis; and
8. Endocrine Disorders.

What is the preferred mode of collection of samples in NBS?

The preferred mode of collection of samples in NBS is the Heel Prick method.

Performance of Newborn Screening.

● Newborn screening shall be performed after twentyfour (24) hours of life but not later than three (3) days from
complete delivery of the newborn.
● A newborn that must be placed in intensive care in order to ensure survival may be exempted from the 3- day
requirement but must be tested by seven (7) days of age.

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.

Licensing and Accreditation.

A COA is valid for 3 years while the LTO is valid only for 1 year.
● COA – issued to Newborn Screening Center (NSC)
● LTO – issued to a Newborn Confirmatory Center (NBCC) If the NBCC is incorporated in a Clin. Lab., the LTO is
valid for 1 year.

Other Related Laws:

1. R.A. No. 7170
 ● “AN ACT AUTHORIZING THE LEGACY OR DONATION OF ALL OR PART OF A HUMAN BODY AFTER DEATH
FOR SPECIFIED PURPOSES”
● A.K.A. “Organ Donation Act of 1991”
● Approved on January 07, 1992

2. R.A. No. 11332

● AN ACT PROVIDING POLICIES AND PRESCRIBING PROCEDURES ON SURVEILLANCE AND RESPONSE TO
NOTIFIABLE DISEASES, EPIDEMICS, AND HEALTH EVENTS OF PUBLIC HEALTH CONCERN, AND
APPROPRIATING FUNDS THEREFOR, REPEALING FOR THE PURPOSE ACT NO. 3573, OTHERWISE KNOWN
AS THE "LAW ON REPORTING OF COMMUNICABLE DISEASES“
● A.K.A. "Mandatory Reporting of Notifiable Diseases and Health Events of Public Health Concern Act".
● April 26, 2019.

3. R.A. No. 10173

● “AN ACT PROTECTING INDIVIDUAL PERSONAL INFORMATION IN INFORMATION COMMUNICATIONS
SYSTEMS IN THE GOVERNMENT AND THE PRIVATE SECTOR, CREATING FOR THE PURPOSE A NATIONAL
PRIVACY COMMISSION, AND FOR OTHER PURPOSES”
● "Data Privacy Act of 2012".
● • Approved on August 15, 2012

BIOETHICS
● Ethics - the branch of philosophy that deals with the morality of human conduct.
● Morality – refers to the quality of human act.
● Ethics is the field or tool in determining the quality of human act, morality on the other hand is the subject of this field.
● Bioethics - it is defined as a philosophical discipline that deals with the study of morality of human conduct in relation to
health in particular, and to human life in general.
● from Greek words:
1. bios (life) and
2. ethos (ethics or behavior)

Bioethical Principles:
•Major bioethical principles:
(1) Principle of Respect for Autonomy,
(2) Principle of Beneficence,
(3) Principle of Non-Maleficence, and
(4) Principle of Justice.

PRINCIPLE OF RESPECT FOR AUTONOMY

● means that the patient has the capacity to act intentionally, with understanding, and without controlling
influences that would mitigate against a free and voluntary act.
● Health care professionals should respect the autonomous decisions of competent adults.
○ Right to privacy
○ Informed Consent
○ Confidentiality

PRINCIPLE OF NONMALEFICENCE
● The principle of nonmaleficence requires that a medical practitioner must not act in a way that entails harm or
injury to the patient, either through acts of commission or omission.
● ‘Primum, Non Nocere” (First, Do No Harm)
○ Harm or injury may be committed by means of malice (dolo) or by means of fault (culpa).

PRINCIPLE OF BENEFICENCE
● It requires that a medical practitioner must act in ways that promote the patient's welfare.
 ● Treatment must be beneficial to patients.

PRINCIPLE OF JUSTICE
● Implies fair distribution of health-care services.
● There are two types of Principle of Justice:
1. Comparative Justice refers to the balancing the competent interests of individuals and groups against one
another.
2. Distributive Justice refers to the fair distribution of health care services to all.

Professional Ethics:
● Professional ethics is concerned with the standards and moral conduct that govern the profession and its
members.
● The official professional ethics of the medical technology profession is Code of Ethics of the Medical
Technology Profession (PRB of MT Resol. No. 72, series of 2022)
○ Supersedes “The Revised Code of Ethics for Medical Technology” enacted on March 07, 1997.
“The Revised Code of Ethics for Medical Technology”
● As I enter into the Practice of Medical Technology, I shall:
○ Accept the responsibilities inherent to being a professional.
○ Uphold the law and shall not participate in illegal works.
○ Act in the spirit of fairness to all and in a spirit of brotherhood toward other members of the profession.
○ Accept employment from more than one employer only when there is no conflict of interest.
○ Perform my task with full confidence, absolute reliability and accuracy.
○ Share my knowledge and expertise with my colleagues.
○ Contribute to the advancement of the professional organization and other health allied organizations.
○ Restrict my praises, criticisms, views and opinions within constructive limits.
○ Treat any information I acquired in the course of my work as strictly confidential.
○ Uphold the dignity and respect of my profession and conduct myself a reputation of reliability, honesty
and integrity.
○ Be dedicated to the use of clinical laboratory science to promote life and benefit mankind.
○ Report any violation of the above principles of professional conduct to authorized agency and to the
ethics committee of the organization.

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