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Medical Technology Laws and Bioethics

Week 2: 02/17/2022
REPUBLIC ACT NO. 5527 PHILIPPINE MEDICAL TECHNOLOGY ACT OF 1969
Council
TOPIC OUTLINE: - The council of Medical Technology Education
R.A 5527 is summarized into three parts: established under this act.
- The training: 3,4,5,6 and 13 -
- The practice: 7 12, 20 26, and 28 29 Board
- The examination: 15 19 and 27 - The Board of Examiners for Medical Technology
Consist of 32 sections under this act.
SECTION 3: COUNCIL OF MEDICAL TECHNOLOGY
SECTION 1: TITLE Chairman: Secretary of Education or Director
e Medical Technology Act of 1969 of Private Education
- An act requiring the registration of Medical Vice-Chairman: Director of Bureau of Research and
Technologists, defining their practice, and other Laboratories of the DOH
purposes. Members:
- Approved: June 21, 1969 One (1) Chairman and Two (2) members of
- Signed by: Former President Ferdinand E. the Board of Medical Technology
Marcos on August 14, 1969 Dean of the Institute of Health of UP
SECTION 2: DEFINITION OF TERMS A representative of the deans or heads of
Medical Technology the Privates schools of medical
- An auxiliary branch of laboratory medicine which technology
deals with the examinations by various President of PAMET (Philippine
chemical, microscopic, bacteriologic and other Association of Medical Technologists)
medical laboratory procedure or techniques President of PSP (Philippine Society of
which will aid the physician in the diagnosis, study Pathologists)
and treatment of the diseases and in the promotion SECTION 4: COMAPENSATION AND TRAVELING
of health in general. EXPENSES OF COUNCIL MEMBERS
The chairman and members of the Council shall be
Pathologist entitled to twenty five pesos per diem for every
- A duly registered physician who is specially meeting actually attended.
trained in methods of laboratory medicine, or Official receiving regular salaries from the Government
the gross and microscopic study and interpretation shall not receive per diem.
of tissues, secretion and excretions of the human Chairman and members shall be entitled to traveling
body and its functions in order to diagnose expenses in connection to duties and responsibilities
disease, follow its course, determine the effect of SECTION 5: FUNCTIONS OF THE COUNCIL OF
treatment, ascertain cause of death and advance MEDICAL TECHNOLOGY EDUCATION
medicine by means of research. To recommend minimum required curriculum.
To determine and prescribe the number of students,
Medical Technologist account the student-instructor ratio, and the availability of
- A person who engages in the work of medical facilities for instruction.
technology under the supervision of a To approve medical technology school meeting the
Pathologist or licensed physician authorize by requirements and recommended closure to those who
the DOH in places where there is no pathologist found to be substandard.
and who having passed the prescribed course To require all medical technology schools to submit an
(BSMT/BSH) of training and examination is annual report, including the total number of students and
registered under the provision of this act. instructors, a list of facilities available for instruction, a list
of their recent graduates and new admissions, on or
Medical Technician before the month of June.
- A person who not being a graduate of Bachelor To inspect and determine whether a high standard of
of Science in Medical Technology/Bachelor of education is maintained.
Science in Hygiene, but having passed the
To certify for admission into an undergraduate internship
corresponding civil service examination,
students who have satisfactorily completed three years of
performs the work of medical technology under the
the medical technology course or its equivalent and to
supervision of a registered medical technologist
collect from said students the amount of five pesos each
and/or qualified pathologist.
which money accrue to the operating fund of the council.
Formulate and recommend approval of refresher course
Accredited Medical Technology Training Laboratory
for applicants who shall have failed the board
- A clinical laboratory, office, agency, clinic, hospital
examination for the third time.
or sanitarium duly approved by the DOH or its
To promulgate and prescribe rules and regulation of
authorized agency.
foregoing functions.
-
SECTION 6: MINIMUM REQUIRED COURSE
Recognized School of Medical Technology
At least 4 years Medical Technology Course
- Any school, college, or university which offers a
12 months satisfactory Internship
course in Medical Technology approved by
Department of Education in accordance with the Includes the following subjects:
requirements under this act, upon - English
recommendation of the council of Medical - Spanish
Technology Education - Social Science
- - General Zoology
- Botany
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- Mathematics maintenance of good ethics and standards in the
- College Physics practice of medical technology
- General Chemistry Investigation such violations of this Act or of the rules
- Qualitative Chemistry and regulations; issued subpoena and subpoena duces
- Quantitative Chemistry tecum
- Biochemistry Draft such rules and regulations as may be necessary
- Gross Anatomy to carry out the provision of this Act
- Histology SECTION 12: REMOVAL OF THE BOARD
- Physiology Any member of the Board may be removed by the
- Clinical Parasitology President of the Philippines for the ff. reasons:
- General Pathology 1. Neglect of duty
- Microbiology 2. Incompetency
- Biostatistics 3. Malpractice or unprofessional
- Clinical Laboratory Methods (including 4. Unethical
hematology, serology, blood banking, clinical 5. Immoral or dishonorable conduct
microscopy, applied microbiology, and Opportunity to defend himself
parasitology, histopathologic techniques, and The President shall have the power to suspend and
cytotechnology) appoint a temporary member in the place
SECTION 7: BOARD OF EXAMINERS OF MEDICAL SECTION 13: ACCREDITATION OF SCHOOLES OF
TECHNOLOGY MEDICAL TECHNOLOGY AND OF TRAINING
The Board of Medical Technology is composed of: LABORATORIES
Pathologist appointed by the President of the Department of Education shall approve schools of
Philippines medical technology in accordance with the provisions of
(2) Two members who are registered medical this Act. The Department of Health or its authorized
technologists appointed by the President of the agency shall upon recommendation of the Council of
Philippines Medical Technology Education approve laboratories
The chairman shall serve for three years, one member for for accreditation as training laboratories for Medical
two years and the third member for one year. Technology students or postgraduate trainees. Required
No member shall be allowed more than (1) one fields for accreditation:
reappointment. 1. Bacteriology
The president of the Philippines shall fill the vacancy may 2. Serology
occur, but appointee shall serve only the unexpired term 3. Parasitology
of the incapacitated member. 4. Hematology
5. Biochemistry
CURRENT BOARD OF MEDICAL TECHNOLOGY 6. Scope of activities of said laboratory offers
Chairman: Marilyn A. Cabal Barza sufficient training in laboratory procedures
Member: Marian M. Tantingco SECTION 14: INHIBITION AGAINST THE PRACTICE OF
Member: Vacant MEDICAL TECHNOLOGY
SECTION 8: QUALIFICATIONS OF EXAMINERS No person shall practice or offer to practice medical
To be a member of Board of Examiners he/she: technology without previously obtaining a valid certificate
- Is a Filipino citizen ü Is of good moral character of registration from the Board that registration shall not
- Is a qualified Pathologist, or duly registered required of the following:
medical technologists with a degree in BSMT/BSH a. Duly registered physicians
- Has been in the practice of laboratory medicine or b. Medical technologist from other countries call
medical technology for at least (10) ten years prior in consultation or visiting or exchange professors
to his appointment to colleges or universities: provided, that they are
- Is not a member of the faculty of any medical only practicing the said function
technology school or have any pecuniary interest, c. Medical technologist in the service of the
direct or indirect, in such institution. United States Armed Forces stationed in the
SECTION 9: EXECUTIVE OFFICER OF THE BOARD Philippines rendering services as such for
The Commissioner of Civil Service shall be the members of the said forces only
Executive Officer of the Board and shall conduct the SECTION 15: EXAMINATION
examinations given by it. The Secretary of the Board Written examination shall be given by the Board in the ff.
Examiners appointed in accordance with Section ten of Location:
Act Numbered Four Thousand Seven, as amended, shall - Greater Manila Area
also be the Secretary of the Board. He shall keep a - Cebu
register of all persons to whom certificates of - Davao
registration have been granted. Examination is given during the month of August or
SECTION 10: COMPENSATION OF MEMBERS OF THE September
BOARD OF EXAMINERS FOR MEDICAL TECHNOLOGY Written notices of such examination shall be published
Each member of the Board shall receive as in at least (3) three newspaper of national circulation by
- P10.00 for each applicant examined the Secretary of the Board at least (30) days prior to the
- P5.00 for each applicant granted a Certificate of date of examination
Registration without examination
SECTION 11: FUNCTIONS AND DUTIES OF THE BOARD
Administer the provision of this act
Administer oaths in connection with the administration of
this act
Issue, suspend and revoke certificates of registration
Look into conditions affecting the practice of medical
technology in the Philippines and, whenever necessary,
adopt such measures as may be deemed proper for the
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SECTION 19: RATING IN THE EXAMINATION
In order to pass the examination, a candidate must obtain
a general average of at least (75) seventy-five percent
in the written test, with no rating below fifty percent
in any major subjects
Provided, that the candidate has not failed in at least sixty
percent of the subjects computed according to their
relative weights.
Failing the board exam for three times = 12 months
refresher course in an accredited medical technology
school or 12-month postgraduate training in an
accredited laboratory
Universities offering Refresher Course
- Centro Escolar University
- Professional and Continuing Education
- Trinity University of Asia
SECTION 20: OATH TAKING
SECTION 16: QUALIFICATION OF EXAMINATION All successful examinees shall be required to take a
Every applicant for examination under this Act, shall prior professional oath before the board or before any person
to the date thereof, furnish the Board satisfactory proof authorized to administer oaths prior to entering upon the
that he or she: practice of medical technology in the Philippines.
a. Is in good health and is of good moral SECTION 21: ISSURANCE OF CERTIFICATION OF
character. REGISTRATION
b. Has completed a course of at least (4) four years
leading to the degrees of BSMT/BSH.
c. Persons having graduated from other
paramedical professions who are performing
medical technology for the last five years prior
to enactment of this Act provided they meet the
minimum requirements exceeding (1) one-year
undergraduate internship or practical training.
SECTION 17: SCOPE OF EXAMINATION
The examination questions shall cover the following
subjects with their respective relative weights:
-
-
-
-
- Clinical Microscopy (Analysis of Urine and Body

- Histopathologic Techniques, Cytotechnology,


Medical Technology Laws, Related Laws and its
implementing rules, and the code of ethics

Compute for the general average of the Board Exam


results:
SUBJECT SCORE WEIGHT
Clinical Chemistry 78 X. 20 15.6
Microbiology and 89 X. 20 17.8
Parasitology
Hematology 67 X. 20 13.4
Blood Banking and 96 X. 20 19.2
Serology
Clinical Microscopy 76 X.10 7.6
Histopathologic 80 X. 10 8.00 Every applicant who has satisfactorily passed the
Technique and MTL required examination for medical technologist shall be
TOTAL 81.6% issued a certificate of registration, provided that no such
** No less than 50% in the correct answers in major certificate shall be issued to any successful applicant who
subjects has not attained the age of twenty-one (21) years old.
All certificates must be signed by the members of the
The Board shall prepare the schedule of subjects for board and attested by its Secretary.
examination and to submit the same to the The certificates must be displayed in the workplace of
Commissioner of Civil Service for publication at least the Medical technologist.
four (4) months before the date of examination. Upon application filed after the approval of this Act not
SECTION 18: REPORTING OF RATING later than ninety days after the Board shall have been fully
Within 120 days after the completion of the examination, constituted, the Board shall issue a certificate of
report the result thereof to the Commissioner of Civil registration without examination to persons:
Service, who shall submit the result to the President of - Graduated with a BSMT/BSH in duly recognized
the Philippines for approval. schools of medical technology in the Philippines or
foreign countries who have been in the practice

3
of medical technology for at least three years The roster shall contain the name, address and
at the time of the passage of this Act in laboratories citizenship of each registered Medical Technologist,
in the Philippines or in foreign countries duly date of registration or issuance of certificate, and
accredited by the Bureau of Research and other data which in the opinion of the Board are pertinent.
Laboratories, Department of Health SECTION 29: PENAL PROVISIONS
- Graduated from other paramedical professions Without prejudice to the provision of the Medical Act of
who are already civil service eligible by authority 1959 as amended, pertaining to illegal practice of
of the other Boards of profession and who are Medicine, the following shall be punished by a fine of
actually performing medical technology not less than two thousand (2000) pesos nor more
practice for the last five years prior to the than five thousand (5000) pesos, or imprisonment for
enactment of this Act. not less than six (6) months nor more than two (2)
SECTION 22: FEES years, or both, in the discretion of the court.
The Board shall charge each applicant for examination Any person who shall practice Medical Technology in the
and registration the sum of fifty (50) pesos Philippines without being registered or exempted from
Twenty five (25) pesos for each certificate of registration in accordance with the provisions of the Act;
registration issued without prior examination Any medical technologist, even if duly registered, who
Ten pesos (10) for issuance of a new certificate to shall practice medical technology in the Philippines
replace certificate lost, destroyed or mutilated without the necessary supervision of a qualified
The Board shall charge the sum of all such fees shall be pathologist or physician authorized by the
paid to the disbursing officer of the Civil Service Department of Health;
Commission who shall pay from the receipts thereof, all Any medical technologist who shall knowingly made a
authorized expenses of the Board including the fraudulent laboratory report;
compensation of each member. Any duly registered medical technologist who shall
SECTION 23: REFUSAL TO ISSUE CERTIFICATE refuse or fail, after due warning by the Board to display
The board shall refuse to issue a certificate of registration his certificate of registration in the place where he
to any person with the ff. reasons: works;
- Convicted by the court of competent jurisdiction of Any person presenting or attempting to use as his
any guilty of immoral or dishonorable conduct own, the certificate of registration of another;
- Incurable communicable diseases Any person who shall give any false or fraudulent
- Unsound mind device of any kind to the Board of any member
SECTION 24: ADMINISTRATIVE INVESTIGATION thereof obtaining a certificate of registration as
Revocation or suspension of Certificates shall be Medical Technologist;
conducted under administrative investigation by at Any person who shall impersonate any registrant of a
least two members of the Board and one legal officer fake or the same name;
during the said investigation. Any person who shall attempt to use a revoked or
Revocation unanimous vote of all the three members suspended certificate of registration;
Reprimand or Suspension majority vote of the board Any person who shall in connection with his name
(but not exceeding two years of suspension) otherwise, assume, use or advertise any title or
If revocation or suspension is imposed by the Board, the description tending to convey the impression that he
medical technologists is required to surrender his is a Medical Technologist without holding a valid
license and certificate of registration within 30 days certificate of registration;
after the decision becomes final. Any person who shall violate any provision of this Act;
The suspension shall run from the date of such surrender. or
SECTION 25: APPEAL Any person or corporate body who shall violate the
The revocation or suspension of a certificate made by the rules and regulations of Board or orders promulgated
Board shall be subject to appeal to the Civil Service by it after having been duly approved and issued by the
Commissioner whose decision shall become final President of the Philippines upon recommendation of the
thirty (30) days after its promulgation, unless the Commissioner of Civil Service for the purpose of carrying
respondent within the same period has appealed to the out the provisions of this Act.
office of the President of the Philippines. SECTION 30: SEPARABILITY CLAUSE
SECTION 26: REINSTATEMENT, REISSUE OR, If any provision of this Act or the application of such
REPLACEMENT OF CERTIFICATES provision to any person or circumstance is declared
The Board may, upon application and for reason deemed invalid by a court of competent jurisdiction, the remainder
proper and sufficient, reissue any revoked registration of this Act or of the application of such provision to other
certificate. persons or circumstances shall not be affected by such
The suspension of a certificate of registration shall be declaration.
automatically lifted upon the expiration of the period of SECTION 31: REPEALING CAUSE
suspension and said certificate shall be re-issued to the All Acts, executive orders, rules and regulations, or parts
medical technologist concerned upon request. thereof inconsistent with the provisions of this Act are
SECTION 27: FOREIGN RECIPROCITY hereby repealed: Provided, However, That, nothing in
No foreigner shall be admitted to examination, or be given this Act shall be construed as repealing or amending any
a certificate of registration or be entitled to any rights and portion of the Medical Act of 1959 (R.A. 2382, as
privileges under this Act, unless the country or state amended by R.A. 4224), the Clinical Laboratory Act of
which he is a subject or citizen permits Filipino 1966 (R.A. 4688), and the Blood Banking Law of 1956
Medical Technologist to practice within its territorial (R.A. 1517).
limits on the same as the subject citizen of said country SECTION 32: EFFECTIVITY
or state. This Act shall take effect upon its approval.
SECTION 28: ROSTER OF MEDICAL TECHNOLOGIST
A Roster of Medical Technologists shall be prepared
annually by the Secretary of the Board.

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Medical Technology Laws and Bioethics
Week 3: 02/24/2022
REPUBLIC ACT NO. 5527 AND ITS AMENDMENTS

Topic Outline: SECTION 22 (FEES)


(3) three Amendments to R.A 5527 RA 5527
R.A 6138 of August 31, 1970 (3 amendments) The Board shall charge each applicant for examination
Section 16, 21, and 22 and registration the sum of fifty (50) pesos
Presidential Decree 498 of June 28, 1974 (12 Twenty five (25) pesos: certificate of registration
amendments) issued without prior examination
Sections: 2,3,4,7,8,11,13,16,17,21,29, Ten pesos (10): to replace certificate lost, destroyed or
and 31 mutilated
Presidential Decree 1534 of June 11, 1978 (5
amendments) RA 6138
Sections: 3,8,11,13, and 31 Examination and Registration The Board shall charge
each applicant for examination and registration the sum
REPUBLIC ACT NO. 6138: AN ACT TO AMEND CERTAIN of fifty (50) pesos
SECTIONS OF REPUBLIC ACT NUMBERED FIVE 10 pesos allocated for registration
THOUSAND TWENTY SEVEN, KNOWN AS THE
PHILIPPINE MEDICAL TECHNOLOGY ACT OF 1969.
SECTION 16 (QUALIFICATION OF EXAMINATION)
RA 5527
Has completed a course of at least four years leading to
the degrees of Bachelor of Science in Medical
Technology or Bachelor of Science in Hygiene.
Graduated from other paramedical professions who are
actually performing medical technology for the last five (5)
years prior to the enactment of this Act provided they
meet the minimum requirements mentioned in
Section Six exceeding one-year undergraduate
internship or practical training.

RA 6138
Has completed a course of at least four years leading to
the degrees of Bachelor of Science in Medical PRESIDENTIAL DECREE NO. 498: AMENDING
Technology or Bachelor of Science in Hygiene. SECTIONS, TWO, THREE, FOUR, SEVEN, EIGHT,
Graduate from some other paramedical profession has ELEVEN, THIRTEEN, SIXTEEN, SEVENTEEN, TWENTY
been actually performing medical technology for the last ONE, AND TWENTY NINE OF REPUBLIC ACT NO.
five (5) years prior to the date of examination, if such 5527, ALSO KNOWN AS PHILIPPINE MEDICAL
performance began prior to the enactment of this Act. TECHNOLOGY ACT OF 1969
SECTION 21 (ISSURANCE OF CERTIFICATE OF RA 5527
REGISTRAION)
RA5527
Certification of registration without examination to
persons:
- Graduated with a BSMT/ BSH in duly recognized
schools of medical technology in the Philippines or
foreign countries who have been in the practice of
medical technology for at least three (3) years at
the time of the passage of this Act. PD 498
- Other paramedical professions who are already Section 2 (Definition of Terms)
civil service eligible by authority of the Board of a. Practice of Medical Technology
profession and who are actually performing b. Medical Laboratory Technician
medical technology practice for the last five (5)
years prior to the enactment of this Act. DEFINITION OF TERMS
a. Practice of Medical Technology. A person shall be
RA 6138 deemed to be in the practice of medical technology
Certification of registration without examination to within the meaning of this Act, who shall for a fee,
persons: salary or other compensation or reward paid or given
- Graduated with a BSMT/ BSH in duly recognized directly or indirectly through another, renders any of the
schools of medical technology in the Philippines or following professional services for the purpose of
foreign countries who have been in the practice of aiding the physician in the diagnosis, study and
medical technology, for at least three (3) years treatment of diseases and in the promotion of health in
prior to the filing of the application. general:
- Other persons who having graduated from other 1. Examination of tissues, secretions and excretions of
paramedical professions are already civil service the human body and body fluids by various
eligible by authority of the other Boards of electronic, chemical, microscopic, bacteriologic,
profession and who have been actually performing hematologic, serologic, immunologic, nuclear, and
medical technology practice for the last five (5) other laboratory procedures and techniques either
years prior to the filing of the application. manual or automated:
2. Blood banking procedures and techniques
3. Parasitologic, Mycologic and Microbiologic The president of the Philippines shall fill the vacancy may
procedures and techniques occur, but appointee shall serve only the unexpired term
4. Histopathologic and Cytotechnology; provided that of the incapacitated member.
nothing in this paragraph shall inhibit a duly
registered medical laboratory technician from PD 498
performing histopathologic techniques and Medical Technology Board under Professional
procedures. regulation Commission (PRC)
5. Clinical research involving patients or human beings Recommendation coming from PRC and appointed by
requiring the use of and/or application of medical the President
technology knowledge and procedures Each member will serve 3 years after appointment or
6. Preparations and standardization of reagents, until their successors shall have been appointed and duly
standards, stains and others, provided such qualifies.
reagents, standards, stains and others are SECTION 8 (QUALIFICATION OF EXAMINERS)
exclusively for the use of their laboratory RA5527
7. Clinical laboratory quality control To be a member of Board of Examiners he/she:
8. Collection and preservation of specimens Is a Filipino citizen
b. Medical Laboratory Technicians. A person certified Is of good moral character
and registered with the Board as qualified to assist a Is a qualified Pathologist, or duly registered
medical technologist and/or qualified pathologist in the medical technologists with a degree in BSMT/BSH
practice of medical technology as defined in this Act. Has been in the practice of laboratory medicine or
SECTION 3 (COUNCIL OF MEDICAL TECHNOLOGY medical technology for at least (10) ten years prior
EDUCATION) to his appointment
RA 5527 Is not a member of the faculty of any medical
Chairman: Secretary of Education or Director of Private technology school or have any pecuniary interest,
Education direct or indirect, in such institution.
Vice Chairman: Director of Bureau of Research and
Laboratories of the DOH PD 498
Members: 1) x x x
1 Chairman and Two members of the Board of 2) x x x
Medical Technology 3) Is a duly registered medical technologist of the
Dean of the Institute of Health of UP Philippines with the degree of Bachelor of Science in
A representative of the deans or heads of the Medical Technology/Bachelor of Science in
Privates schools of medical technology Hygiene/Public Health
President of PAMET ü President of PSP 4) x x x
5) Is not a member of the faculty of any medical
PD 498 technology school for at least two (2) years prior to
Chairman: Commissioner of the Professional Regulation appointment or having any pecuniary interest direct
Commission (PRC) or indirect in such institution.
Vice Chairman: Chairman of the Board of Medical SECTION 11 (FUNCTIONS AND DUTIES OF THE BOARD)
Technology RA5527
Members: (c) Issue, suspend and revoke certificates of registration
Two members of the Board of Medical for the practice of medical technology.
Technology
Director of Private Education or its duly PD 498
authorized representative Subsection (c) of Section 11 of the same Act is hereby
Director of Bureau of Research and Laboratories amended and subparagraphs (g), (h) and (i) are hereby
of the DOH added.
A representative of the deans or heads of the (c) Issue, suspend and revoke certificates of registration
Privates schools of medical technology for the practice of medical technology and medical
Section 4 (COMPENSATION AND TRAVELING laboratory technician
EXPENSES OF COUNCIL OF MEMBERS)
RA5527 (g) To determine the adequacy of the technical staff of all
The chairman and members of the Council shall be clinical laboratories and blood banks before they could be
entitled to a twenty-five pesos per diem for every meeting licensed with the Department of Health in accordance
actually attended. with R.A. No. 4655 and 1517;
Officials receiving regular salaries from the Government (h) To prescribe the qualification and training of medical
shall not receive per diem. technologist as to special fields of the profession and
supervise their specialty examination conducted by the
PD 498 professional organization of medical technologists
Chairman: P50.00 accredited by the Professional Regulation Commission;
Members: P25.00 (i) To classify and prescribe the qualification and training
Regardless they receive regular salaries or not. of the technical staff of clinical laboratories as to: Chief
SECTION 7 (MEDICAL TECHNOLOGY BOARD) Medical Technologist; Senior Medical Technologist;
RA5527 Medical Technologist and Medical Laboratory
Pathologist and (2) two members who are registered Technician.
medical technologists are appointed by the President of SECTION 13 (ACCREDITATION OF SCHOOLS OF
the Philippines MEDICAL TECHNOLOGY AND OF TRAINING
The chairman shall serve for three years, one member for LABORATORY)
two years and the third member for one year. RA5527
No member shall be allowed more than (1) one Department of Education shall approve schools of
reappointment. medical technology.

6
The Department of Health or its authorized agency shall PD 498
approve laboratories for accreditation as training All certificate shall be signed by the members of the
laboratories for medical technology students or Board and by the Commissioner of the Professional
postgraduate trainees. Regulation Commission.
Recommendation: Council of Medical Technology Upon application filed and the payment of the required
Education fee of one hundred and fifteen pesos (P115.00) the
Board shall issue a certificate of registration as medical
PD 498 technologist without examination to persons
Department of Education and Culture shall approve Graduated with Bachelor of BSMT/BSPH in duly
schools of medical technology. recognized schools of medical technology in the
The Professional Regulation Commission shall Philippines or in any foreign country (standard of
approve laboratories for accreditations as training medical technology education is substantially the same
laboratories for medical technology students or post as ours), and in addition shall have been in the practice
graduate trainees. of medical technology for at least three (3) years prior
Recommendation: Board of Medical Technology to the filing of the application).
SECTION 16 (QUALIFICATIONS OF EXAMINERS) Graduated from other professions have been actually
RA 6138 performing medical technology practice for the last eight
Has completed a course of at least four (4) years leading (8) years prior to filing of the application, Provided, that
to the degree of Bachelor of Science in Medical such performance began prior to June 21, 1969.
Technology or Bachelor of Science in Hygiene. Issue a certificate of registration as medical laboratory
Graduated from some other paramedical profession has technician without examination to any person who upon
been actually performing medical technology for the last application and payment of the required fee of fifty
five (5) years prior to the date of the examination, if such pesos (P50.00):
performance began prior to the enactment of this Act. Passed the civil service examination for medical
technician on March 21, 1964
PD 498 Has finished a two-year college course and has at
Has completed a course of at least four (4) years leading least one (1) year of experience as medical laboratory
to the degree of Bachelor of Science in Medical technician, provided, that for every year of deficiency in
Technology or Bachelor of Science in Public Health. college attainment two (2) years of experience may be
Graduated from some other profession and has been substituted
actually performing medical technology for the last five (5) Who has at least ten (10) years experience as medical
years prior to the date of the examinations, if such laboratory technician as of the date of approval of this
performance began prior to June 21, 1969. Decree regardless of his academic attainment may
SECTION 17 (SCOPE OF EXAMINATION) qualify for registration without examination
RA5527 Has failed to pass the board examination for medical
The Board shall prepare the schedule of subjects for technology but had obtained a general rating of at least
examination and to submit the same to the Commissioner 70%.
of Civil Service for publication at least four (4) months Registered medical laboratory technician when employed
before the date of examination. \ in the government shall have the equivalent civil service
Board may change, add to or remove from the list of eligibility not lower than second grade.
subjects or weights above, as progress in the science of SECTION 29 (PENAL PROVISION)
medical technology may require, subject to the prior Subparagraph (j) of the same Act is hereby amended to read
approval of the council. as follows:

PD 498 in his employ who is not a registered medical


The Board shall prepare the schedule of subjects for technologist/medical laboratory technician to engage in
examination and to submit the same to the the practice of medical technology or recommend for
Commissioner of the Professional Regulation appointment anyone to the position of medical
Commission for publication at least thirty (30) days technologist/medical laboratory technician knowing that
before the date of examination.
Board may change, add to or remove from the list of SECTION 31 (REPEALING CLAUSE)
subjects or weights above as progress in the science of All laws, executive orders, decrees, rules and regulations
Medical Technology may require, subject to the prior or parts thereof, inconsistent with the provisions of this
approval of the Professional Regulation Commission, and Decree are hereby repealed, amended or modified
publication of the change or amendment at least accordingly.
three (3) months prior to the date of examination in
which the same is to take effect. PRESIDENTIAL DECREE 1534: FURTHER AMENDING
SECTION 21 (ISSUANCE OF CERTIFICATE OF REPUBLIC ACT NO. 5527 AS AMENDED BY
REGISTRATION) PRESIDENTIAL DECREE NO. 498 OTHERWISE KNOWN
RA 6138 AS THE PHILIPPINE MEDICAL TECHNOLOGY ACT OF
Certificate of registration without examination to persons: 1969
- Graduated with a BSMT/ BSH in duly recognized SECTION 3 (COUNCIL OF MEDICAL TECHNOLOGY
schools of medical technology in the Philippines or EDUCATION
foreign countries who have been in the practice of PD 498
medical technology, for at least three (3) years Chairman: Commissioner of the Professional Regulation
prior to the filing of the application. Commission (PRC)
- Other persons who having graduated from other Vice Chairman: Chairman of the Board of Medical
paramedical professions are already civil service Technology
eligible by authority of the other Boards of Members:
profession and who have been actually performing Two (2) members of the Board of Medical
medical technology practice for the last five years Technology
prior to the filing of the application.
7
Director of Private Education or its duly Recommendation: Board of Medical Technology
authorized representative
Director of Bureau of Research and Laboratories PD 1534
of the DOH The Department of Education and Culture shall approve
A representative of the deans or heads of the schools of Medical Technology in accordance with the
Privates schools of medical technology provisions of this Act, as amended, in conjunction with
the Board of Medical Technology.
PD 1534 The Department of Health through the Bureau of
Chairman: Director of Higher Education Research and Laboratories shall approve laboratories for
Vice Chairman: Chairman Professional Regulation accreditation as training laboratories for medical
Commission (PRC) technology students or post-graduate trainees in
Members: conjunction with the Board of Medical Technology.
Chairman and two (2) members of the Board of REPEALING CLAUSE
Medical Technology PD 498
Director of Bureau of Research and Laboratories All laws, executive orders, decrees, rules and regulations
of the DOH or parts thereof, inconsistent with the provisions of this
A representative of the deans or heads of the Decree are hereby repealed, amended or modified
Privates schools of Medical Technology and accordingly.
Public Health
President of PAMET PD 1534
President of PSP All those Executive Order, Decrees, Rules and
SECTION 8 (QUALIFICATION OF EXAMINERS) Regulations, or parts thereof inconsistent with the
PD 498 provisions of this Decree are hereby repealed, amended
1) x x x or modified accordingly: Provided, however, That nothing
2) x x x in this Decree shall be construed as repealing or
3) is a duly registered medical technologist of the amending any portion of the following:
Philippines with the degree of Bachelor of Science in - Medical Act of 1959
Medical Technology/Bachelor of Science in - Clinical Laboratory Act of 1966
Hygiene/Public Health - Blood Banking Law of 1956
4) x x x
5) is not a member of the faculty of any medical SUMMARY:
technology school for at least two (2) years prior to Sections 2, 4,7,17, 22 and 29 are amended once
appointment or having any pecuniary interest direct Sections 3,8,11,13,16,21 and 31 are amended twice

PD 1534
No person shall be appointed as a member of the Medical
Technology Board unless he or she:
- . . . is a qualified Pathologists, 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; . . . ."

SECTION 11 (FUNCTIONS AND DUTIES OF THE BOARD)


PD 1534
Subparagraphs (g) and (i) of Section 11 of Republic Act No.
5527 as amended are hereby repealed.
g) To determine the adequacy of the technical staff of all
clinical laboratories and blood banks before they could be
licensed
(i) To classify and prescribe the qualification and training
of the technical staff of clinical laboratories

Section 13 (ACCREDITATION OF SCHOOLS OF


MEDICAL TECHNOLOGY AND OF TRAINING
LABORATORY)
PD 498
Department of Education and Culture shall approve
schools of medical technology.
The Professional Regulation Commission shall approve
laboratories for accreditations as training laboratories for
medical technology students or post graduate trainees.

8
Medical Technology Laws and Bioethics
Week 4: 03/03/2022
CHED MEMORANDUM ORDER NO. 13 SERIES OF 2017
5.2 Nature of the Field Study
Topic Outline:
The BSMT/BSMLS is a four-year program consisting of
Article I: Introduction general education and professional courses.
Article II: Authority to Operate 4th year level is the internship program of one (1) year
Article III: General Provisions in a CHED-accredited training laboratory
Article IV: Program Specifications
Article V: Curriculum Rotational sections for the internship Program:
Article VI: Required Resources 1. Clinical Chemistry
Article VII: Compliance of HEI's 2. Hematology
Article VIII: Transitory, Repealing and Effectivity 3. Microbiology
Provisions 4. Immunohematology (Blood Banking)
5. Immunology and Serology
6. Urinalysis and Body Fluids (Clinical Microscopy)
SUBJECT 7. Parasitology
Policies, standards and guidelines (PSG) for the Bachelor 8. Histopathologic/Cytologic Techniques and other
of Science in Medical Technology/ Medical Laboratory emergent technologies
Science (BSMT/BSMLS) Program
It was adopted and promulgated by the Commission on 5.3 Program Goals:
Higher Education in accordance with R.A 7722 otherwise For the Graduates to:
known as 1. Develop the knowledge, skills, professional attitude
the outcomes-based quality assurance system. and values in the performance of clinical laboratory
procedures needed to help the physician in the
ARTICLE I: INTRODUCTION proper diagnosis, treatment, prognosis and
SECTION 1. Rationale prevention of diseases
Implementation of the - 2. Acquire critical thinking skills in medical
based standards/outcomes-based education technology/medical laboratory science
Specifies the core competencies expected of 3. Engage in research and community-related activities
BSMT/BSMLS graduates 4. Participate in activities related to promoting the
In recognition of the spirit of OBE, the PSG allow the HEI profession and actively engage in lifelong learning
to initiate curricular innovations in line with the undertakings
assessment of how best to achieve learning outcomes in 5. Develop collaborative and leadership qualities
their particular contexts and their respective missions.
5.3 Specific professions/careers/opportunities for
ARTICLE II: AUTORITY TO OPERATE Graduates
SECTION 2. Government Recognition 1. Licensed Medical Technologists/ Medical Laboratory
Private higher education institutions (PHEIs), state Scientists
universities and colleges (SUCs) and local universities 2. Diagnostic Molecular Scientists
and colleges (LUCs): 3. Research Scientists
- Must secure proper authority from the Commission 4. Educators
in accordance with the rules and regulations; 5. Diagnostic Product Specialists
policies and standards. 6. Public Health Practitioners
- All PHEIs with an existing BSMT/BSMLS program 7. Healthcare Leaders
are required to shift to an outcomes-based
approach based on PSG. 5.3 Allied Medical Fields:
A MT/MLS graduate may practice in the following fields:
ARTICLE III: GENERAL PROVISION 1. Public Health/ Epidemiology
SECTION 3 2. Veterinary Laboratory Science
Follow minimum standards and other requirements and 3. Molecular Biology/ Biology
prescriptions for BSMT/ BSMLS. 4. Nuclear Science
5. Forensic Science
SECTION 4 6. Health Administration/Management
HEIs are allowed to design curricula suited to their own 7. Food and Industrial Microbiology
contexts mission provided that they can demonstrate that
the same leads to the attainment of the required minimum SECTION 6. Program Outcomes
set of outcomes. 1. Common to all programs in all type of schools
HEIs can use the CHED Implementation Handbook for 2. Common to Health Sciences
Outcomes-Based Education (OBE) and Institutional 3. Specific to BSMT/BSMLS
Sustainability Assessment (ISA) as a guide. 4. Common to a horizontal type as defined in CMO no.
PSG is based on the K-12 basic education system and 46 s. 2012
on the new GE program.
ARTICLE IV: PROGRAM SPECIFICATIONS 6.3 Specific to Bachelor of Science in Medical
SECTION 5. Program Description Technology/ Medical Laboratory Science

5.1 Degree Name The graduates have the ability to:


Bachelor of a. Demonstrate technical competence in the
Science in Medical Technology/ Bachelor of Science performance of clinical laboratory tests in aid of
diagnosis, treatment, and management of diseases
via à vis biosafety and waste management;
b. Demonstrate analytical and critical thinking skills in o Recognize errors/ problems and perform root cause
the workplace; analysis to establish a course of action; and
c. Engage in the collection, analysis, and projection of o apply the principles of educational methodology and
health information for improving the health care resource management. C. Engage in the collection.
management system; analysis, and projection of
d. Demonstrate inter personal skills, leadership
qualities, and ethical practice of the profession; c. Engage in the collection, analysis and projection of
e. Apply research skills in relevant areas of Medical health information for improving the health care
Technology/ Medical Laboratory Science practice: management system.
f. Participate in community oriented activities;
g. Engage in life long learning activities; and Performance Indicators:
h. Demonstrate effective teaching and communication
skills. The graduates shall be able to:
collect health information for health care management.
SECTION 7. Performance Indicators analyze health information data;
1. Demonstrate technical competence in the interpret health information data; and
performance of clinical laboratory tests in the aid of contribute in designing and planning a course of action to
diagnosis, treatment, and management of disease address health concerns and issues.
biosafety and waste management.
2. Demonstrate analytical and critical thinking skills in d. Demonstrate inter-personal skills, leadership
the workplace qualities. and ethical practice of the profession
3. Engage in the collection, analysis and projection of
health information for improving the health care Performance Indicators:
management system.
4. Demonstrate inter-personal skills, leadership The graduates shall be able to:
qualities, and ethical practice of the profession work effectively with peers. with multidisciplinary, and
5. Apply research skills in relevant areas of Medical multi-cultural teams;
Technology/ Medical Laboratory Science practice demonstrate good inter-personal skills with patients and
6. Participate in community-oriented activities co-workers;
7. Engage in life-long learning activities plan and organize activities;
8. Demonstrate effective teaching and communication
practice professionalism;
skills
practice the principles of data security and patient's
confidentiality; and
Section 7. Performance Indicators
a. Demonstrate technical competence in the exhibit ethical behavior.
performance of clinical laboratory tests in the aid of
diagnosis, treatment, and management of disease e. Apply research skills in relevant areas of Medical
biosafety and waste management. Technology/Medical Laboratory Science practice:

Performance Indicators: Performance Indicators:

The graduates shall be able to: The graduates shall be able to:
o Collect, handle, and process biological specimens identify research topic relevant to Medical
properly and safety; Technology/Medical Laboratory Science:
o Perform laboratory testing accurately through the use appropriate research methods;
use of appropriate techniques, skills, and perform the research according to plan;
technology; analyze and interpret research data; and
o Analyze and interpret laboratory test data; disseminate research results.
o Monitor testing procedures, equipment, and
professional/ technical competency using quality f. Participate in community-oriented activities
assurance methodologies;
o Operate instruments properly and perform Performance Indicators:
appropriate preventive and corrective maintenance;
o Adhere to all laboratory safety rules and regulations; The graduates shall be able to:
o Use computers and laboratory software competently; engage in community-oriented activities;
o Discuss appropriate and novel technology for plan and organize medical technology related activities in
Medical Technology/Medical Laboratory Science the community.
application; apply the principles of good practice in community service
o Carry out the evaluation of new procedures and and social responsibility; and
instruments; and implement. monitor, and evaluate activities in the
o Apply principles of educational methodology and community.
laboratory management
g. Engage in life-long learning activities
b. Demonstrate analytical and critical thinking skills in
the workplace Performance Indicators:

Performance Indicators: The graduates shall be able to:


discuss trends/developments in Medical
The graduate shall be able to: Technology/Medical Laboratory Science
o Demonstrate skills in quality assurance and participate in professional organizations; and
continuous quality improvement; engage in continuing professional development activities.
o Evaluate the validity of the generated data and
assure its reliability before reporting;
10
h. Demonstrate effective teaching and communication skills

Performance Indicators:

The graduates shall be able to:


provide proper information and instruction to patients;
implement proper classroom management and
instruction:
follow oral and written instructions;
prepare correct communication materials; and
communicate effectively across multiple platforms

ARTICLE V: CURRICULUM
Section 8. Curriculum Description
HEIs offering Medical Technology/ Medical Laboratory
Science education may exercise flexibility in their
curricula offering.
Medical Technology/Medical Laboratory Science courses
as prescribed in the sample program of the study shall be
implemented

Summary of Units
General Education Core Courses 24 units
General Education Elective Courses 9 units
General Education Mandated Courses 3 units
Physical Education Course 8 units
NSTP Course 6 units
Core Course 25 units
Professional Courses 65 units
Research Courses 5 units
Clinical Internship Course 28 units

11
- A full-time faculty member shall have a regular
teaching load regardless of lecture or laboratory
classes with no more than three (3) preparations
in any one semester
- A faculty member shall have a full-time status in
only one (1) HEI
- Must be an active member of good standing in the
following:
1. PRC-Accredited Professional Organizational
for Medical Technologist
2.
of vacancy, substitute or replacement must be
with similar or higher qualifications shall be
employed
- Employment shall be in accordance with the
institutional policy
- Probationary period according to Provision of the
ARTICLE VI: REQUIRED RESOURCES
Labor Law Code
SECTION 10. Sample Curriculum Map
- Every college/university shall have a Faculty
I Introduction: basic concepts are merely introduced manual
P Practice: the concepts and principles are presented with - Pursue continuing professional development
applications
- Involve in research activities
D Demonstrate: I + P + skills acquisition
- At least 60% of every college/university faculty
shall be in full-time status.
SECTION 13. Administration
- The required number of faculty members in
HEI offering BSMT/BSMLS program shall be administered by
teaching force should be at least 2 full-time faculty
a full-time dean/head with the following qualifications:
for every 50 students.
Filipino citizen
Must be of good moral character SECTION 15. Library
Registered Medical Technologist in the Philippines with Separate CHED Issuance
updated PRC license Adequate library recourses, sufficient quantity which shall
with graduate degree: serve the needs of the students

Public Health SECTION 16. Laboratory and Facilities


Education Administration Lecture classroom requirements:
MT/MLS related programs 1. There shall be a maximum of 1:40 faculty/Student
Doctor or Medicine with Masters in Ratio
Medical Technology, Public Health, Education 2. A classroom shall have an entrance and an exit door
Administration (Educational Management, (swing-out type)
Administration and Leadership)
Other MT/MLS related programs Laboratory room requirements:
Has at least 5 years of very satisfactory teaching There shall be a maximum of 1:20 faculty/student ratio
experience (MT/MLS Professional Courses) Fully-equipped laboratory facilities for adequate
Has at least 2 years managerial/supervisory competence instruction.
and technical expertise in school management Shall have entrance and exit door (swing - type) and a
Must be an active member of good standing in the minimum floor space of one square meter for every 1-2
following: students and a locker for every 1-5 students.
a. PRC-Accredited Professional Organizational for Rooms shall be well-lighted and well ventilated
Medical Technologist Each laboratory room shall have:
b. Association of Medical Technology 1. Continuous and adequate supply of water, gas and
Has no teaching assignment/administrative function in electricity
other HEIs 2. Readily accessible safety and first aid devices
General functions and responsibilities of the Dean/ Head
Readily accessible safety and first aid devices
of Medical Technology:
Fire extinguishers
Administers general policies of the college/university Emergency Shower
Exercises educational leadership among faculty, as First aid kit/cabinet
stated in Manual of Regulations for Private Schools Safety posters
8th Edition 1992, Art. VIII, Sec. 41 on the Exhaust systems and/or fume hood
Qualifications and Functions of the Dean Acid resistant laboratory tabletops
Eye wash
SECTION 14. Faculty Sand box
For those teaching non-licensure MT/MLS courses
- Has an appropriate Masteral/Doctoral degree in Institution shall provide the requirements for the following
related fields laboratories:
1. Chemistry (Inorganic and Organic Chem., Analytical
For those teaching courses included in the licensure Chem. & Biochemistry)
examination, the following qualifications are required: 2. Anatomy and Physiology
- Registered MT with current and valid PRC license 3. Clinical Chemistry
-
and other MT/MLS related fields
- Must have at least one year (1) clinical experience

12
4. Immunology and Serology
5. Blood banking
6. Hematology
7. Microbiology
8. Clinical Microscopy
9. Parasitology
10. Histopathology
11. Toxicology
12. Molecular Biology and Diagnostics

Institution may combine the laboratories such as:


Professional Laboratories:
1. Clinical Chemistry, Hematology, Blood Banking and
ImmunoSerology
2. Microbiology, Parasitology, Clinical Microscopy and
Histopathology

Simulated Clinical Laboratory is highly recommended


Appropriate and safe waste disposal system

ARTICLE VII: COMPLIANCE OF HEIs


Using the CHED Implementation Handbook for OBE and ISA,
and HEI shall develop the following items which will be
submitted to CHED when they apply for a permit for a new
program:

SECTION 17:
SECTION 18: Proposed curriculum including curriculum map
SECTION 19: Proposed performance indicators
SECTION 20: Proposed outcomes-based learning plan
(syllabus) for each course
SECTION 21: Proposed system of program assessment and
evaluation
SECTION 22: Proposed system of program Continuous
Quality Improvement (QCI)

ARTICLE VIII: TRANSITORY, REPEALING AND


EFFECTIVITY PROVISIONS SECTION 25. Repealing Clause
SECTION 23. Transitory Provision Supersedes all previous issuance concerning MT/MLS
Private higher education institutions (PHEIs), state education which may be inconsistent or contradictory with
universities and colleges (SUCs) and local universities any of the provisions.
and colleges (LUCs) with existing authorization to
operate are hereby given a period of three (3) years from SECTION 26. Effectivity Clause
the effectivity thereof to fully comply with all the Shall take effect beginning of school year 2018-2019
requirements in this CMO. May 08, 2017 Quezon City, Philippines
Prescribed minimum curricular requirements in this CMO SIGNED BY: Patricia B. Licuanan, PhD (chairman)
shall be implemented starting Academic Year 2018-2019.

SECTION 24. Sanctions


Non-compliance with the provisions after due process
shall cause the Commission to impose sanctions.
Sanctions for MT/MLS schools shall be based on the 3-
year consolidated Medical Technology Licensure
examination institutional performance and the outcome
Performance of their graduates in the Medical
Technology Examination (MTLE)
The institutional passing average or performance of the
graduates of MT/MLS schools in the MTLE for the past
three (3) years shall be based on the data provided by the
Professional Regulatory Board of Medical Technology.

Outcome/result of the Joint CHED-PRC monitoring and


evaluation activities of the following areas:
1. Dean/Administration
2. Faculty
3. Curriculum and Instruction
4. Students (Admission, Promotion, and Retention)
5. Laboratory and Learning Facilities
6. Research and Publications
7. Clinical Internship Training Program

13
Medical Technology Laws and Bioethics
Week 5: 03/11/2022
REPUBLIC ACT NO. 8981

SECTION 1. TITLE Ensure and safeguard the integrity of all licensure


examinations
An act modernizing the Professional Regulation
Commission, repealing for the purpose Presidential Functions of the Chairperson:
Presiding officer: preside over the meetings of the
Professional Regulation Commission and commission
Chief executive officer: responsible for the
purposes. implementation of policies and programs
SECTION 6. COMPENSATION AND OTHER BENEFITS
SECTION 2. STATEMENT OF POLICY
The Chairperson shall receive compensation and
recognizes the important role of professionals in allowances equivalent to that of a Department
nation-building Secretary.
promotes the sustained development of a reservoir Commissioners shall receive compensation and
of professionals allowances equivalent to that of an Undersecretary.
competence has been determined by honest and Entitled to retirement benefits provided under RA
credible licensure examinations 1568 as amended by RA 3595
standards of professional service and practice are
internationally recognized and considered world- SECTION 7: POWERS, FUNCTIONS AND
class RESPONSIBILITIES OF THE COMMISSION
regulatory measures, programs and activities that a. Administration, implementation and enforcement of
foster professional growth and advancement regulatory policies; enhancement and maintenance of
professional and occupational standards and ethics
SECTION 3. PROFESSIONAL REGULATION b. Performance of any and all acts, enter into contracts,
COMMISSION make rules and regulations, issue orders and other
administrative issuance
3-man commission attached to the office of the
c. . Review, revise, and approve resolutions, embodying
President for general direction and coordination
policies
d. Administration and conduction licensure examinations
SECTION 4. COMPOSITION
of the various regulatory boards:
1 full-time Chairperson - Determine and fix the places and dates of
2 full-time Commissioners examinations
Appointed by the President for a term of seven (7) - Use publicly or privately owned buildings and
years without reappointment to start from the time facilities for examination purposes
they assume office. - Conduct more than 1 licensure examination:
Provided, that, when there are 2 or more
At the expiration of the Chairperson, most senior
examinations given in a year, at least 1
Commissioners shall temporarily assume and
examination shall be held on weekdays (Monday
perform the duties and functions of the Chairperson
to Friday): if only 1 examination is given in a year,
until a permanent Chairperson is appointed.
this shall be held on weekdays.
- Commission is authorized to require refresher
Qualifications:
course where the examinee has failed to pass
At least 40 years of age three (3) times
With a valid certificate of registration/professional - Approval of the results of examination; adopt
license measures to preserve the integrity and inviolability
Valid professional ID/certificate of competency of licensure examinations
issued by the Commission or a valid professional - Approve the results of examinations and the
license issued by any government agency release of the same
- Appoint supervisors and room watchers from
Familiar with the principles and methods of
among the employees of the government and/or
professional regulation and/or licensing
private individuals with baccalaureate degrees
has had at least five (5) years of executive or (trained by the Commission for the purpose,
management experience entitled to a reasonable daily allowance for every
Provided, 1 Commissioner must be a past examination day actually attended)
Chairperson/member of a Professional Regulatory - Publish the list of successful examinees
Board. - Provide schools, colleges and universities, public
and private, offering courses for licensure
SECTION 5. EXERCISE OF POWERS AND FUNCTIONS examinations, with copies of sample test questions
OF THE COMMISSION on examinations recently conducted by the
THE COMMISSION SHALL: Commission and copies of the syllabi or terms of
Sit and act as a body to exercise general specifications of subjects for licensure
administrative, executive and policy-making examinations
functions - Impose the penalty of suspension or prohibition
Establish and maintain a high standard of admission from taking licensure examinations to any
to practice to all professions examinee charged and found guilty of violating the
rules and regulations
x. Preparation of annual report of accomplishments on
e. Admission of successful examinees to the practice of programs, projects and activities of the Commission
the profession or occupation; cause the entry of their during the year for submission to Congress after the
names on its registry book and computerized close of its calendar year
database; issue certificates of registration/professional y. Other functions and duties to carry out the provisions
of this Act
registration number, signed by all the members of the
Board concerned and the Chairperson, with the official SECTION 8: REGIONAL OFFICES
seal of the Board and the Commission affixed thereto authorized to create regional offices as may be
which certificate shall be the authority to practice f necessary to carry out their functions
f. Having the custody of all the records of the various
Boards (exams, deliberation, records, investigations SECTION 9: POWERS, FUNCTIONS AND
and results) RESPONSIBILITIES OF THE VARIOUS PROFESSIONAL
g. Determination and fixation of the amounts of fees to be REGULATORY BOARDs
charged and collected for examination, registration, a. To regulate practice of the professions
registration without examination, professional b. To monitor the conditions affecting the practice of the
identification card, certification, docket, appeal, profession or occupation, ocular inspection in
replacement, accreditation industrial, mechanical, electrical or chemical plants
h. Appointment subject to the Civil Service laws, rules, or establishments, hospitals, clinics, laboratories,
and regulations, officials and employees of the testing facilities, mines and quarries, other
Commission necessary for the effective performance of engineering facilities and in the case of schools, in
its functions and responsibilities, prescribe their duties coordination with the Commission on Higher
and fix their compensation and allowances including Education (CHED)
other fringe benefits; and to assign and/or reassign c. To hear and investigate cases arising from violations
personnel, to organize or reorganize the structure of of their respective laws (may issue subpoena,
the Commission; and create or abolish positions or subpoena duces tecum); the decision of the
change the designation of existing positions. Professional Regulatory Board shall, unless
i. Submission and recommendation to the President of appealed to the Commission, become final and
the Philippines the names of licensed/registered executory after fifteen (15) days from receipt of
professionals for appointment as members of various notice of judgment or decision
Professional Regulatory Boards. d. To delegate the hearing or investigation of
j. Approval and issuance of COR/license and ID with or administrative cases filed (except in cases where the
without examination to a foreigner whose certificate of issue or question involved strictly concerns the
registration issued therein has not been suspended or practice of the profession or occupation, in which
revoked upon the recommendation of the Professional case, the hearing shall be presided over by at least
Regulatory Board. one (1) member of the Board concerned assisted by
k. Authorization of any officer of the Commission to a Legal or Hearing Officer of the Commission)
administer oaths e. To conduct, through the Legal Officers of the
l. Supervision of foreign nations who are authorized to Commission, summary proceedings on violations
practice their professions in the Philippines f. Subject to final approval by the Commission, to
m. Monitoring the performance of schools in examinations recommend registration without examination,
and publishing the results in newspaper of national issuance of COR and professional ID.
circulation g. After due process; suspension, revocation and
n. Adopt and institute a comprehensive rating system for reinstation of COR and ID.
universities, colleges, and training institutes based on h. To prepare, adopt and issue the syllabi or tables of
the passing ratio and overall performance of students specifications of the subjects for examinations in
in board examinations consultation with the academe (submission of results
o. Administrative supervision over the boards and its in all subjects within 10 days from the last day of
members exam unless extended by the Commission),
p. Adopt and promulgate rules and regulations determine the appropriate passing general average
q. Full computerization of all licensure examinations and rating in an examination if not provided for in the law
registration not later than the year 2003 regulating the profession
r. Investigation and decision of administrative matters i. To prepare an annual report of accomplishments on
under the jurisdiction of Commission programs, projects and activities of the Board.
s. Investigation of motu proprio to any member of the
Professional Regulatory Boards for neglect of duty, SECTION 10. COMPENSATION OF THE MEMBERS OF
incompetence, unprofessional, unethical, immoral or THE PROFESSIONAL REGULATORY BOARDS
dishonorable conduct, commission of irregularities in
Members of the Board: equivalent to at least, two (2)
the licensure examinations which taint or impugn the
salary grades lower than the Commissioner
integrity and authenticity of the results of the said
examinations Chairperson of the Board: monthly compensation of
t. Issuance of summons, subpoena and subpoena duces 2 steps higher than the salary grade of the members
tecum of the Board
u. Holding in contempt in erring party or person only upon They shall be entitled to other allowances and
application with a court of competent jurisdiction benefits provided under existing laws
v. Call upon request for assistance, cooperation and SECTION 11. PERSON TO TEACH SUBJECTS FOR
coordination to implement the policies, program and LICENSURE EXAMINATION ON ALL PROFESSIONS
activity holders of valid certificates of registration and valid
w. Initiation of investigation upon complaint; to forward the professional licenses of the profession
records of the case to the office of the city or provincial
who comply with the other requirements of the CHED
prosecutor for the filing of the corresponding
SECTION 12. ASSISTANCE OF LAW ENFORCEMENT
information in court by the lawyers of the legal services
AGENCY
of the Commission
15
Any law enforcement agency shall render assistance 7- SUBPARAGRAPH (1) BY HEADS OF GOVERNMENT
in enforcing the regulatory law of the profession AGENCIES OR OFFICERS OF PRIVATE
ENTITIES/INSTITUTIONS
SECTION 13. APPROPRIATIONS
Imprisonment Fine
Amount necessary to carry out the initial
implementation of this Act shall be charged against Any head of a not less than not less than Fifty
government agency six (6) months thousand pesos
sums as may be necessary for the continued or officer(s) of a and one (1) day (P50,000.00) to
implementation of this Act shall be included in the private to not more not more than
succeeding General Appropriations Act. firm/institution who than six (6) Five hundred
violates Section 7 years thousand pesos
SECTION 14: AUTHORITY TO USE INCOME subpar. (1) (P500,000.00)
*** a) To administer, implement and enforce the regulatory
Commission is hereby authorized to use its income policies of the national government with respect to the
not exceeding the amount of Forty-five million pesos regulation and licensing of the various professions and
(P45,000,000.00) a year for a period of five (5) years occupations under its jurisdiction including the
after the effectivity of this Act to implement the enhancement and maintenance of professional and
program for full computerization of the operations of occupational standards and ethics and the enforcement of
the Commission, subject to the usual accounting and the rules and regulations relative thereto.
auditing requirements
SECTION 17. IMPLEMENTING RULES AND
SECTION 15: PENALTIES FOR MANIPULATION AND
REGULATIONS
OTHER CORRUPT PRACTICES IN THE CONDUCT OF
PROFESSIONAL EXAMINATIONS Within 90 days after the approval of this Act;
Commission, Board, accredited Professional
Organizations, DBM, CHED shall prepare and
SECTION 16. PENALTIES FOR VIOLATION OF SECTION promulgate the necessary rules and regulations
needed to implement the provisions of this Act .
Imprisonment Fine
Manipulates Not less than Fifty thousand SECTION 18. TRANSITORY PROVISIONS
or rigs six (6) years pesos
and one (1) (P50,000.00) to Incumbent Commissioner: Chairperson
licensure
examination day to not not more than Two (2) incumbent Associate Commissioners:
results more than One hundred Commissioners
twelve (12) thousand Incumbent Executive Director: Assistant
secretly
years pesos Commissioner without need of new appointment
informs or
(P100,000.00)
makes
known SECTION 19. SEPARABILITY CLAUSE
licensure SECTION 20. REPEALING CLAUSE
examination insofar as it requires completion of the requirements
questions of the Continuing Professional Education (CPE) as a
prior to the condition for the renewal of the license are hereby
conduct of repealed
the
examination SECTION 21. EFFECTIVITY
tampers with Approved: December 5, 2000
the grades in Signed By: President Joseph Ejercito Estrada
professional
licensure PROFESSIONAL REGULATION COMMISION OFFICIALS
examinations
Accomplices Four (4) years Twenty
and one (1) thousand
day to six (6) pesos
years (P20,000.00) to
not more than
Forty-nine
thousand
pesos
(P49,000.00)
Accessories Two (2) years Five thousand
and one (1) pesos CURRENT BOARD OF MEDICAL TECHONOLOGY
day to four (4) (P5,000.00) to
years not more than
Nineteen
thousand
pesos
(P19,000.00)
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.

16
REPUBLIC ACT NO.10912
“CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016” CPD
LAW
The technology is so advanced and for us to cope up • Process of honing the knowledge, skills and
with the changes brought up by this phenomenon we attitude of a professional
must study, re-study, evaluate and re-evaluate our
capabilities. Change is constant and the ever “EDUCATION IS NOT THE LEARNING OF
changing world we live in it is almost imperative to FACTS, BUT THE TRAINING OF THE MIND TO
keep progressing in our professional endeavors. The
THINK.”
best option to keep up with this is through the use of
continuing development program to stay ahead of
the curb. REPUBLIC ACT 10912
Otherwise known as the “Continuing
Professional Development (CPD) Act of 2016”
CONTINUING PROFESSIONAL
, is an act which requires CPD as the
DEVELOPMENT PROGRAM- refers to the
mandatory requirement for the renewal of
process of training and developing the
Professional Identification Card.
professional knowledge and skills through
independent, participation-based or - It is an act mandating and
interactive learning. strengthening the continuing
professional development program for
Through seminar and workshops.
all the regulated professions and
• Continuing means without break in creating the professional development
continuity council in appropriating funds and for
- Constant and is continuous other related purposes.
- License expires after 3 years and needs
• Professional means person’s work
to be renewed.
requiring special training
- Now professionals are mandatory to
-Job or profession that will require you
acquire CPD units before renewing the
advanced education or training where you
license.
will earn money when rendering your
professional services • Fusion of Senate Bill No. 2581 and House
Bill No. 6423 = CPD Law of 2016
• Development means a process of growing
or changing and becoming more advanced -this law took effect in Aug.16, 2016 but it
- It is a transitional change of improvement was approved in July 21, 2016
from being less expert to more expert.
REPUBLIC ACT NO.10912
“CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016” CPD
LAW
• Senate Bill No. 2581, which was approved DEFINITION OF TERMS
by the Senate on August 3, 2015, was
adopted as an amendment to House Bill No. • AIPO/APO refers to:
6423 by the House of Representatives on Accredited Integrated Professional
May 23, 2016. Organization or the
Accredited Professional Organization in a
• The CPD Act Lapsed into Law on July 21, given profession.
2016 and it took effect on August 16, 2016
- For medical technologies the only APO
. • Approved: July 21, 2016 by President is PAMET
Benigno S. Aquino III
QUALIFICATIONS OF THE PROFESSIONAL:

• ASEAN Qualifications Reference Framework


(AQRF) refers to the device that enables
comparisons of qualifications across ASEAN
Member States.

• ASEAN Mutual Recognition Arrangement


(ASEAN MRA) refers to a regional
arrangement entered into by the ASEAN
Member States, predicated on the mutual
recognition of qualifications, requirements
met, licenses and certificates granted,
experience gained by professionals, in order
to enhance mobility of professional services
within the region.

• Philippine Qualifications Framework (PQF)


refers to the quality assured national system
for the development, recognition and award
of qualifications at defined levels, based on
standards of knowledge, skills and values,
REPUBLIC ACT NO.10912
“CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016” CPD
LAW
acquired in different ways and methods by - Applicable most to senior medtechs
learners and workers. wherein what they know may already
be obsolete because of the change and
DECLARATION OF POLICY innovation of the progression.
• It is hereby declared the policy of the State to
• As our skills and knowledge matures
promote and upgrade the practice of professions in
the country. Towards this end, the State shall (indication of confidence)
institute measures that will continuously improve
• Opens doors to excellent future
the competence of the professionals in accordance
with the international standards of practice,
employment opportunities
thereby, ensuring their contribution in uplifting the
• Improves productivity with the help of
general welfare, economic growth and development
motivated and skilled employees
of the nation.

- Professionals benefit the most, primarily to • Delivers a deeper understanding of what it


promote and upgrade the profession in the means to be a professional, along with a
country. greater appreciation of the implications and
- The ultimate outcome of a well-planned impacts of your work.
continuing development is it safeguards the
public, the employer, the professional and the - In example before, medtechs are
professional’s careers thus CPD provides four- allowed to mouth pipette that today
fold benefit: we learn violates the minimum safety
Public- customers, patients, clients precautions in the lab.

Employers-where we work Professional’s career and Practice of


Professional and their career
professions

Professionals • Ensures that we maintain and enhance the


knowledge and skills we need to deliver a
• Improves the competence of the professional service to your customers,
professionals in accordance with the clients and the community.
international standards of practice; ensures
your capabilities keep pace with the current - Ensures what we are giving to our
standards meaning it ensures that you and patient is quality service.
your knowledge stay relevant and up to date.
REPUBLIC ACT NO.10912
“CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016” CPD
LAW
• Helps professionals continue to make a
meaningful contribution to the society and
nation for economic growth.

• Helps advance the body of knowledge and


technology within the profession.

Employer

• Endorses a learning culture in the


organization

• Enhances the reputation of the company


among prospective employees and clients

• Increases employee retention

Public and Nation


- Patient, client

• Promotes and upgrades the practice of


professions in the country

• Ensuring their contribution in uplifting the


general welfare, economic growth and
development of the nation.

Additional note:

 Even with masteral it is still a


requirement to undergo CPD.
 Masteral can be counted as CPD units
used for re-applying the license only
once as it is still considered as one.
REPUBLIC ACT NO.10912
“CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016” CPD
LAW
STRENGTHENING THE CPD PROGRAMS • Doctoral Degree, Master’s Degree, Post-graduate
Diploma/Certificate/ Diplomate/Fellowship Program
There shall be formulated and implemented CPD
2. NON-FORMAL LEARNING
Programs in each of the regulated professions in order
to: - Learning that is acauired in addition or alternatively to
formal learning which may be structured and need more
1. Enhance and upgrade the competencies and
flexible according to the education and training
qualifications of professionals for the practice of their
arrangement including CPD directed or self-directed
professions pursuant to the PQF, the AQRF and the ASEAN
activities.
MRAs;
Self-directed: online training, local or international
2. Ensure national and international alignment of
seminar, non-degree courses, institutions or company-
competencies and qualifications of professionals through
sponsored programs that did not undergo CPD
career progression mechanism leading to specialization/
accreditation but can be applied for. Applied certificates
sub-specialization
will be awarded to by the CPD.
3. Ensure the development of quality assured mechanisms
CPD accredited: conducts activities with readily-available
for the validation, accreditation and recognition of formal,
certificates that are counted as CPD units.
non-formal and informal learning outcomes, including
professional work experiences and prior learning
• Professional activities-- Promotes and facilitates
4. Respond to national, regional and international labor knowledge, skills and values as a professional.
market and industry needs.
conference, seminar/workshop/colloquium, in-service
5. Recognize and ensure the contributions of professionals training, webinar, tutorial, study tour/plant visit, exhibit,
in uplifting the general welfare, economic growth and poster presentation, program/module development,
development of the nation. publication, invention, consultancy, and
recognition/award/title
NATURE OF CPD PROGRAMS
• The CPD Programs consist of activities that range from • Volunteer engagement-Refers to the activity done under
structured to non-structured activities, which have the ambit of social responsibility. May or may not be
learning processes and outcomes. These include, but not directly involved in the profession but improves a
limited to the following: professional’s social aspect. :

1. FORMAL LEARNING: medical mission/outreach program, environmental


- Educational arrangements such as curricular initiative, livelihood program, disaster/calamity
qualifications, teaching-learning requirements that take assistance, service to worthy projects and CSR projects
place in education and training institutions recognized by
relevant authorities and which lead to diplomas or 3. INFORMAL LEARNING- learning that occurs in daily lives
qualifications. and it is assessed through the recognition, validation and
accreditation processes.
REPUBLIC ACT NO.10912
“CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016” CPD
LAW
• Reading of books, magazine journals, and the like that 4. Coordinate with academe, concerned government
will develop leadership, management, and other skills agencies and other stakeholders in the
implementation of the CPD Programs and other
4. ONLINE LEARNING ACTIVITIES – Use of internet and
other web-based solutions measures

5. PROFESSIONAL WORK EXPERIENCE – special tasks you 5. Coordinate with concerned government agencies
do in relation to your work on how to improve knowledge in the development of mechanisms and guidelines, in
and skills in your profession or undergoing consultation. the grant and transfer of credit units earned from all
learning processes and activities
• Reading of books, magazine, journals, and the like on
how to improve knowledge and skills in the field of CPD COUNCIL- unique in every profession
professional practice
-consists of 3 persons
• Providing professional consultancy services to clients
• The chairperson of the CPD Council shall be the
- Attendance and participation in the conference member of the PRB so chosen by the PRB concerned
and conventions sponsored by your accredited to sit in the CPD Council.
professional organization should be given
appropriate CPD unit. - If there are no officers qualified that should
be coming from PAMET or academe the
PRB(Philippine Regulatory Board) shall give
recomendees to PRC.
POWER, FUNCTIONS AND
RESPONSIBILITIES OF THE PRC AND • First member: president or officer of the AIPO/APO
duly authorized by its Board of Governors/Trustees.
THE PROFESSIONAL REGULATORY
BOARD -From the accredited Professional Organization or
PAMET
1. Organize CPD Council for each of the
• Absence of the AIPO/APO: the PRB concerned shall
regulated professions and promulgate
submit within ten (10) working days from notification
guidelines for their operation
of such absence, a list of three (3) recommendees
- Each profession has specific CPD council.
from the national professional organizations. The
2. Review existing and new CPD Programs for all the PRC shall designate the first member within thirty
regulated professions (30) days from receipt of the list.

3. Formulate, issue and promulgate guidelines and • Second member: president or officer of the
procedures for the implementation of the CPD national organization of deans or department
Programs chairpersons of schools, colleges or universities
offering the course requiring the licensure
examination.
REPUBLIC ACT NO.10912
“CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016” CPD
LAW
-From the academe • Monitor and evaluate the implementation of the CPD
Programs;
• Absence of such organization: the PRB concerned
shall submit, within ten (10) working days from • Assess and/or upgrade the criteria for accreditation of
notification of such absence, a list of three (3) CPD Providers and their CPD Programs on a regular basis;

recommendees from the academe. The PRC shall • Develop mechanisms for the validation, accreditation
designate the second member within twenty (20) and recognition of self-directed learning, prior/informal
working days from receipt of the list. learning, online learning, and other learning processes
through professional work experience;
• The term of office of the chairperson of the CPD
Council shall be coterminous with his/her -CPD Council will be give accreditation to the self-directed
incumbency in the PRB unless sooner replaced by learning
the PRB concerned through a resolution, subject to • Conduct researches, studies and benchmarking for
the approval of the PRC. international alignment of the CPD Programs;

• The first and second members shall have a term of • Issue operational guidelines, with the approval of the
office of two (2) years unless sooner replaced PRC and the PRB concerned; and
through a resolution by the AIPO/APO concerned or
• Perform such other functions related or incidental to the
the organization of deans or heads of departments,
implementation of the CPD.
respectively. However, members of the CPD Council
who are appointed by the PRC may be replaced CPD PROGRAM IMPLEMENTATION
before the end of the two (2)-year period, upon the
recommendation of the PRB through a resolution.
AND MONITORING
• The CPD is hereby made as a mandatory
POWERS, FUNCTIONS AND requirement in the renewal of the PICs of all
RESPONSIBILITIES OF THE CPD registered and licensed professionals under the
COUNCIL - THE CPD COUNCIL FOR regulation of the PRC.

EACH PROFESSION • All duly validated and recognized CPD credit units
earned by a professional shall be accumulated and
• Ensure the adequate and appropriate provision of CPD
transferred in accordance with the Pathways and
Programs for their respective profession;
Equivalencies of the PQF.
- Ensures the adequacy of professionals needs of
CPD activities • The PRC and the PRBs, in consultation with the
AIPO/APO, the Civil Service Commission (CSC), other
• Evaluate and act on applications for accreditation of CPD concerned government agencies and industry
Providers and their CPD Programs; stakeholders, shall formulate and implement a
-Gives approval to CPD providers on a particular program Career Progression and Specialization Program for
REPUBLIC ACT NO.10912
“CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016” CPD
LAW
every profession. The Career Progression and the pertinent provisions of the Revised Penal Code,
Specialization Program shall form part of the CPD. the New Civil Code and other applicable laws.

• All concerned government agencies and private -If a professional is judge guilty relating to CPD there
firms and organizations employing professionals shall can be suspension or revocation of certificate of
include the CPD as part of their human resource registration or specialization.
development plan and program.
• A professional who is adjudged guilty of any
- CPD units shall be included in the Human fraudulent act relating to the CPD shall also be meted
Resource Development Plan and Program of with the penalty of suspension or revocation of
the employer. his/her PRC Certificate of Registration and/or
Certificate of Specialization. In case of a
FINAL PROVISIONS government official or employee who is
- CPD Council works under the supervision of party to any fraudulent act relating to the
the PRC such that they will review approve CPD, he/she shall also be subject to the
the budget used by the council. administrative penalties that may be
• The funding requirement herein mentioned shall be imposed under the anti-graft laws, the
used for the regular operations of the CPD Councils, Administrative Code and the Code of Conduct of
including the monitoring of the conduct of the CPD Public Officials and Employees.
Programs.
• Separability Clause. If any part or provision of
• The PRC shall review and approve the proposed
budget for each CPD Council, taking into this Act is declared invalid or unconstitutional, the
other provisions not affected thereby shall remain in
consideration the reasonable expenses that will be
incurred for travel, honorarium/allowances, and per full force and effect.
diems, when attending official CPD Council meetings • Repealing Clause. All laws, decrees, executive
or performing other related functions assigned to
orders and other administrative issuances or parts
them.
thereof, which are inconsistent with the provisions of
• The PRC and the PRBs, in consultation with the this Act, are hereby repealed or modified
AIPO/APO and other stakeholders, shall promulgate accordingly.
the implementing rules and regulations (IRR) within
• Effectivity. - This Act shall take effect fifteen (15)
six (6) months from the effectivity of this Act.
days following its complete publication in the Official
- IRR are specific rules on how to implement Gazette or in two (2) newspapers of general
the law. circulation in the Philippines.

• Fraudulent acts relating to the implementation and


enforcement of this Act shall be punishable under
PRC RESOLUTION NO. 1032 SERIES OF 2017
“Implementing Rules and Regulations (IRR) of Republic Act No. 10912 known as the Continuing Professional
Development (CPD) Act of 2016”
IRR- are made that if there are changes to be made Medtech used to have 45 units but in 2020, it
resolution will be published instead of changing the law is only 15 units.
which is complicated.
PIC RENEWAL MINIMUM CREDIT
CPD COUNCIL PERIOD UNITS REQUIRED FOR
THE PROFESSION
• Every CPD Council shall be composed of JANUARY-JUNE 2017 0
chairperson and two (2) members. JULY-DECEMBER 2017
30%
• The Chairperson shall act in the following JANUARY-DECEMBER
functions: 2019 60%
JANUARY 2019-
• Preside the meetings
ONWARDS 100%
• Direct or supervise the activities

• Submit the Council’s annual report to the REQUIRED SENIOR


Planning and Monitoring Division not later PROFESSION CPD CREDIT CITIZEN/PWD
UNITS
than January 15 of the succeeding year

• Sign the following:


- CoA: Certificate of Accreditation of qualified MEDICAL
CPD providers TECHNOLOGY
- CoAP: Certificate of Accreditation of Program REGISTERED
MEDICAL 15 12
- CCU: Certificate of Credit Units for self-
TECHNOLOGISTS
directed and/or lifelong learning (RMTs)
MEDICAL
CPD PROGRAM LABORATORY 10 8
IMPLEMENTATION AND TECHNICIANS (MLTs)
PRC CPD FAQs 2020 ^
MONITORING
The table below shall be used as a reference for the CPD PROVIDERS
renewal of PIC in the period; however, the PRB
concerned may prescribe their own CPD credit units
• Local CPD Provider
through a resolution subject to the approval of the - Individual/Sole Proprietor
Commission. - Firm/Partnership/Corporation
- Government Institutions/Agencies
The required CPD units by professions every 3
years: • Foreign CPD Provider

- Foreign Entity/Firm /Association


PRC RESOLUTION NO. 1032 SERIES OF 2017
“Implementing Rules and Regulations (IRR) of Republic Act No. 10912 known as the Continuing Professional
Development (CPD) Act of 2016”

CPD COUNCIL OF MEDICAL TECHNOLOGY


LIST OF ACCREDITED CPD PROVIDERS
as of August 8,2020

These are allowed to give CPD credit units with their program as they are directly coordinated with PRC. The
certificate attained here is automatically counted.
PRC RESOLUTION NO. 1032 SERIES OF 2017
“Implementing Rules and Regulations (IRR) of Republic Act No. 10912 known as the Continuing Professional
Development (CPD) Act of 2016”
Frequently Asked Questions • Foreign CPD provider P 8,000.00

• CPD program per offering P 1,000.00


Where to get the application forms?
• Self-directed and/or Lifelong Learning per
- The Continuing Professional Development program P 500.00
(CPD) forms can be downloaded from PRC
website at www.prc.gov.ph or available at Who are not covered by the CPD
Standards and Inspection Division office. Requirement?
How long is the processing of the • Professionals working overseas. However, they
application for accreditation as CPD need to provide proof such as valid Certificate of
Employment or Overseas Employment Certificate
Provider?
duly approved by POEA.
- The period for processing the application is 30
• Newly licensed professionals for the first renewal
days.
cycle (3 years) after obtaining their license.
What is the validity of accreditation for Additional information
CPD Provider? How many units are taken through self-directed
- The accreditation of CPD Provider is valid for learning?
three (3) years. Only 30% of your CPD units are allowed to be from
self-directed learning and the rest shall be from CPD
What is the regulatory period for the
Council accredited.
filing of application for accreditation of
Example:
CPD program/s? 15 units, only 5 U are allowed to be taken through
- The CPD Program/s shall be applied 45 days self-directed learning.
prior to the conduct of the program Who are not covered by the CPD
How much are the prescribed fees for Requirement?
accreditation of CPD Providers, CPD • Professionals working overseas. However, they
Programs, Self-Directed Learning need to provide proof such as valid Certificate of
Employment or Overseas Employment Certificate
and/or Lifelong Learning? duly approved by POEA.
• The Prescribed fees for accreditation are as follows -OFW
(Good for 3 years):
• Newly licensed professionals for the first renewal
• Local CPD provider P 5,000.00 cycle (3 years) after obtaining their license.
PRC RESOLUTION NO. 1032 SERIES OF 2017
“Implementing Rules and Regulations (IRR) of Republic Act No. 10912 known as the Continuing Professional
Development (CPD) Act of 2016”
License expiration date is your birthday.

What activities are covered by CPD?


• Professional track (training offered by accredited
CPD providers, face to face /online)

• Academic track : Master’s degree/Doctorate


degree or equivalent

• Self-directed (training offered by non-accredited


CPD providers, face to face /online): Author of:
Technical paper, Pamphlet / Book or Monograph,
Article in magazine / Newspaper, Inventions
RMT 2023 Republic Act No. 11166 “Philippine HIV and AIDS LEC
2020-2021
1ST SEM
OLFU MEDTECH Policy Act” MTLB
Transcriber: Riyoma Surell 6 211

▪ Passed from mother to baby


Outline ▪ Sharing injecting equipment
At the end of the session, the student must be able to learn: ▪ Contaminated blood transfusions and organ transplants
• Introduction to HIV • Preventive Measures, ➢ You Can’t Get HIV FROM
and AIDS Safe Practices and ▪ Kissing, Hugging, Toilet seats, Bathing, Sweat, Sneezes
• HIV Testing Procedures and cough
• Republic Act No. • Screening Test and ▪ Sharing food, Insect bites
11166 Counseling ❖ Primary Prevention
• General Information • Health and Support ➢ Five ways to Protect yourself
• Definition of Terms Services ▪ Abstinence
• ▪ Monogamous relationship
• The Philippine AIDS Confidentiality
• Discriminatory Acts ▪ Protected sex
Council
▪ Sterile needles
• AIDS Medium Term and Practices and
Corresponding ▪ New shaving/ cutting blades
Plan
➢ You can’t prevent or cure HIV by
• Role of Department of Penalties
▪ Washing after sex
Health • Penalties
▪ Sex with a virgin
• Protection of Human • Administrative Order
▪ Pulling out method
Rights 2017-2019
▪ Spells and herbal medicine
• Information, ▪ Using the contraceptive pill
Education and ❖ Safer Sex Practices:
Communication ➢ Choices made and behaviors adopted by a person to reduce
or minimize the risk of HIV transmission, these may include
Introduction to HIV and AIDS postponing sexual debut, non-penetrative sex, correct and
consistent use of male or female condoms and reducing the
❖ Human Immunodeficiency Virus (HIV) number of sexual partners
➢ The virus, of the type called retrovirus, which infects cells of
the human immune system, and destroys or impairs the cells HIV Testing
function
➢ Infection with HIV results in the progressive deterioration of ➢ Any laboratory procedure done on any individual to
the immune system leading to immune deficiency determine the presence or absence of HIV infection
➢ A condition in humans which the virus invades the helper T ➢ Window Period
cells (CD4 cells) making infected persons vulnerable to ▪ Refers to the period of time, usually lasting from two
various opportunistic life-threatening infections and cancers weeks to six (6) months during which an infected
to occur due to progressive failure of immune system individual will test “negative” upon HIV testing but can
❖ Acquired Immune Deficiency Syndrome (AIDS) – Stage 3 actually transmit the infection
➢ Deficiency of immune system that stems from infection with ➢ Screening Test (HIV-1 and HIV-2)
the Human Immunodeficiency Virus or HIV, making an ▪ ELISA (Enzyme-linked Immunosorbent Assay)
individual susceptible to opportunistic infections ▪ Antibodies + = positive HIV
➢ Predisposes our body to other opportunistic infections and ▪ Antibodies - = negative HIV
malignancies that rarely occur in the absence of sever ➢ Confirmatory Test
immunodeficiency (e.g. pneumocystis pneumonia, CNS ▪ Western blot technique
lymphoma) • Refers to the test performed on samples that have
➢ Persons with HIV positive serology who have ever had a CD4 tested positive reactive to the screening test to find
lymphocyte count below 200 cells/microliter or a CD4 out if the result were true positive or not
lymphocyte percentage below 14% are considered to have ➢ To Confirm HIV positive (+)
AIDS ▪ 2 screening test positive
➢ HIV/AIDS is preventable and manageable but is not curable ▪ 1 confirmatory test positive
CD4 Lymphocyte Blood Detection Tests
CD4 500 (500- CD4 200 CD4 50
1,600
HIV ELISA Screening test for HIV
cells/microliter)
Sensitivity >99.9%
Bacterial infections Pneumocystic Disseminated
Western Blot Confirmatory test
Tuberculosis (TB) carinii Mycobacterium
Specificity >99.9% (when
Herpes Simplex Toxoplasmosis avium complex
combined with ELISA)
Herpes Zoster Cryptococcosis (MAC) infection
Vaginal Coccidiodomycosis Histoplasmosis HIV rapid antibody test Screening test for HIV
Candidiasis Cryptosporiosis CMV retinitis Simple to perform
Hairy leukoplakia Non-Hodgkin’s CNS lymphoma Absolute CD4 lymphocyte count Predictor of HIV progression
Kaposi’s sarcoma lymphoma Progressive Risk of opportunistic infections
multifocal and AIDS when <200 CD4 count
leukoencephalopathy HIV viral load tests Best test for diagnosis of acute
HIV dementia HIV infection correlates with
*TB: Most common opportunistic infection in HIV disease progression and
response to HAART
❖ Mode of Transmission
➢ You Can Get HIV VIA
▪ Sex without condom
Page 1 of 6
[MTLB211] 2.02 “Republic Act No. 1116, Philippine HIV and AIDS Policy Act” I Prof. Sherlyn Joy P. Isip, RMT, MSMT
Anti-Retroviral Drugs ➢ Policies and practices that discriminate (HIV status, sex,
gender, sexual orientation, gender identity and expression,
❖ Nucleoside Reverse Transcriptase Inhibitors: Azidothymidine age, economic status, disability, and ethnicity) or hamper the
(Zidovudine) enjoyment of basic human rights and freedoms guaranteed
❖ Non-Nucleoside Transcriptase Inhibitors: Viramune (Nevirapine) in the Constitution and are deemed inimical to national
❖ Protease Inhibitors: Norvir (Ritonavir) interest
➢ Respect, protect, and promote human rights as the
Differences of HIV-1 and HIV-2 cornerstones of an effective response to the country's HIV
and AIDS situation
HIV-1 HIV-2 ➢ HIV and AIDS education and information dissemination
Found around the world West Africa: increasing cases in should form part the right to health
the US ➢ Inclusion and participation of persons directly and indirectly
affected by the HIV and AIDS situation, especially persons
Immunodeficiency is faster Immunodeficiency develops
living with HIV, are crucial in eliminating the virus
more slowly
➢ Confidentiality and non-compulsory nature of HIV testing and
Shorter incubation period Longer incubation period
HIV-related testing shall always be guaranteed and protected
Highly infectious in early Less infectious in early stages, ➢ Ensure the delivery of non-discriminatory HIV and AIDS
stages (increases risk of much infectious as the virus
services
transmission) develops ➢ Develop redress mechanisms for persons living with HIV to
ensure that their civil, political, economic, and social rights
Epidemiology of HIV Worldwide are protected.
❖ Accordingly, the State shall:
❖ Number of People Living with HIV in 2017 (a) Establish policies and programs to prevent the spread of HIV
➢ East and Southern Africa (19.6 million) due to poverty and deliver treatment, care, and support services to Filipinos living
➢ Western and Central Africa (6.1 million) with HIV
➢ Asia and Pacific (5.2 million) (b) Adopt a multi-sectoral approach in responding to the country's
➢ W. and C/ Europe and N. America (2.2 million) HIV and AIDS situation by ensuring that the whole government
➢ Latin America (1.8 million) approach, local communities, civil society organizations (CSOs),
➢ East Europe and Central Asia (1.4 million) and persons living with HIV are at the center of the process
➢ Caribbean (310,000) (c) Ensure access to HIV- and AIDS-related services by
➢ Middle East and North Africa (220,000) eliminating he climate of stigma and discrimination
❖ Worldwide Epidemiology 2017 (d) Positively address and seek to eradicate conditions that
➢ 37.9 million people living with HIV/AIDS worldwide aggravated the spread of HIV infection (poverty, gender
➢ 770,000 people died of HIV-related illnesses worldwide inequality, marginalization, and ignorance)

Prevalence of HIV according to the Modes of Transmission


Definition of Terms
➢ Male to Male sex only (1,669 or 58%)
❖ Anti-retroviral Therapy (ART): treatment that stops or
➢ Sex with both males and females, among males (611 or 21%)
suppresses viral replication or replications of a retrovirus like HIV,
➢ Male-female sex (306 or 11%)
thereby slowing down the progression of infection;
➢ Mother to child (187 or 6%)
❖ Bullying: severe or repeated use by one or more persons of a
➢ Sharing of infected (89 or 3%)
written, verbal or electronic expression, or a physical act of
➢ Blood transfusion (1 or <1%)
gesture, directed at another person in reasonable fear of physical
➢ No data (24 or 1%)
or emotional harm or damage to one's property; creating a hostile
environment; infringing on the rights; or materially and
Republic Act No. 11166 “Philippine HIV and AIDS Policy Act” substantially disrupting the processes or orderly operation of an
institution or organization;
General Information ❖ Civil Society Organizations (CSOs): groups of
nongovernmental and noncommercial individuals or legal entities;
❖ RA 8504: “Philippine AIDS Prevention and Control Act of ❖ Compulsory HIV Testing: HIV testing imposed upon an
1998” individual characterized by lack of consent, use of force or
➢ Consists of 9 articles intimidation, the use of testing as a prerequisite for employment
➢ With 52 sections or other purposes, and other circumstances when informed choice
➢ Approved on February 13, 1998 by President Fidel V. Ramos is absent;
❖ RA 11166: "Philippine HIV and AIDS Policy Act” ❖ Discrimination: unfair or unjust treatment that distinguishes,
➢ The newest law passed by the legislative department to excludes, restricts, or shows preferences (sex gender, age, sexual
modify certain provision of the original version to be more orientation, gender identity and expression, economic status,
effective in dealing HIV condition in the Philippine setting disability, ethnicity, and HIV status) which has the purpose or
➢ An act strengthening the Philippine Comprehensive Policy on effect of nullifying or impairing the recognition, enjoyment or
HIV/AIDS prevention, treatment, care, and support, and, exercise by all persons similarly situated, of all their rights and
reconstituting the Philippine National Aids Council (PNAC), freedoms;
repealing for the purpose Republic Act No. 8504 ❖ Gender Expression: the way a person communicates gender
➢ Consists of 8 articles identity to others through behavior, clothing, hairstyles,
➢ With 57 sections communication or speech pattern, or body characteristics;
➢ Approved on December 20, 2018 by President Rodrigo R. ❖ Gender Identity: personal sense of identity as characterized,
Duterte among others, by manner of clothing, inclinations, and behavior in
relation to masculine or feminine conventions. A person may have
Declaration of Policies a male or female identity with the physiological characteristics of
the opposite sex;
❖ Health Maintenance Organizations (HMO): juridical entities
➢ Responding to the country's HIV and AIDS shall be anchored
legally organized to provide or arrange for the provision of pre-
on the principles of human rights upholding human dignity
agreed or designated health care services to its enrolled members
for a fixed pre-paid fee for a specified period of time;
Page 2 of 6
[MTLB211] 2.02 “Republic Act No. 1116, Philippine HIV and AIDS Policy Act” I Prof. Sherlyn Joy P. Isip, RMT, MSMT
❖ High-risk Behavior: person's involvement in certain activities that prevent infection by the pathogen and the development of the
increase the risk of transmitting or acquiring HIV; disease;
❖ HIV Counseling: interpersonal and dynamic communication ❖ Post-test Counseling: process of providing risk-reduction
process between a client and a trained counselor, whose objective information and emotional support to a person who submitted to
in counseling is to encourage the client to explore important HIV testing at the time the result is released;
personal issues, identify ways of coping with anxiety and stress, ❖ Prophylactic refers to any agent or device used to prevent the
and plan for the future (keeping healthy, adhering to treatment, transmission of an infection;
and preventing transmission); and in the context of a negative HIV ❖ Redress: refers to an act of compensation for unfairness,
test result, to encourage the client to explore motivations, options, grievance, and reparation;
and skills to stay HIV-negative; ❖ Sexually Transmitted Infections (STIs): infections that are
❖ HIV and AIDS Counselor: any individual trained by an institution spread through the transfer of organisms from one person to
or organization accredited by the Department of Health (DOH) to another as a result of sexual contact;
provide counseling services on HIV and AIDS with emphasis on ❖ Sexual Orientation: direction of emotional, sexual attraction, or
behavior modification; conduct towards people of the same sex (homosexual orientation)
❖ HIV and AIDS Monitoring: documentation and analysis of the or towards people of both sexes (bisexual orientation) or towards
number of HIV and AIDS infections and the pattern of its spread; people of the opposite sex (heterosexual orientation) or to the
❖ HIV and AIDS Prevention and Control: measures aimed at absence of sexual attraction (asexual orientation);
protecting non-infected persons from contracting HIV and ❖ Stigma: dynamic devaluation and dehumanization of an
minimizing the impact of the condition on persons living with HIV; individual in the eyes of others
❖ HIV-Negative: absence of HIV or HIV antibodies upon HIV ❖ Treatment hubs: private and public hospitals or medical
testing; establishments accredited by the DOH to have the capacity and
❖ HIV-Positive: refers to the presence of HIV infection as facility to provide treatment and care services to PLHIV;
documented by the presence of HIV and HIV antibodies in the ❖ Voluntary HIV testing: HIV testing done on an individual who,
sample being tested; after having undergone pre-test counseling willingly submits to
❖ HIV Testing: any facility-based, mobile medical procedure, or such test;
community-based screening modalities that are conducted to ❖ Vulnerable communities: communities and groups suffering
determine the presence or absence of HIV in a person's body. from vulnerabilities such as unequal opportunities, social
❖ HIV Testing Facility: DOH accredited on-site or mobile testing exclusion, poverty, unemployment, and other similar social
center, hospital, clinic, laboratory, and other facility that has the exclusion, making them more susceptible to HIV infection and to
capacity to conduct voluntary HIV counseling and HIV testing; developing AIDS; and
❖ Informed Consent: voluntary agreement of a person to undergo ❖ Workplace: office, premise or work site where workers are
or be subjected to a procedure based on full information, whether habitually employed and shall include the office or place where
such permission is written or conveyed verbally; workers regularly report for assignment in the course of their
❖ Laboratory: area or place, including community-based settings, employment
where research studies are being undertaken to develop local
evidence for effective HIV response; The Philippine AIDS Council
❖ Mature Minor Doctrine: legal principle that recognizes the
capacity of some minors to consent independently to medical ➢ Philippine National AIDS Council (PNAC) was established to
procedures, if they have been assessed by qualified health ensure the implementation of the country's response to the
professionals to understand the nature of procedures and their HIV and AIDS situation. It shall be an agency attached to the
consequences to make a decision on their own; DOH.
❖ Medical Confidentiality: core duty of medical practice where the ❖ Functions:
information provided by the patient to health practitioner and a. Develop the AIDS Medium Term Plan (AMTP) in
his/her health status is kept private and is not divulged to third collaboration with relevant government agencies, CSOs, the
parties. The patient's health status can however, be shared with: PLHIV community;
➢ other medical practitioner involved in the professional care of b. Ensure the operationalization and implementation of the
the patient AMTP;
➢ attending physician, consulting medical specialist, nurse and c. Strengthen the collaboration between government agencies
medical technologist and CSOs;
➢ all other health workers or personnel involved in any d. Develop and ensure the implementation of the guidelines and
counseling, testing or professional care of the patient policies provided in this Act;
❖ Opportunistic infections: illnesses caused by various organism, e. Monitor the progress of the response to the country's HIV and
many of which do not cause diseases in persons with healthy AIDS situation;
immune system; f. Monitor the implementation of the AMTP
❖ Partner Notification: process by which the "index client", g. Mobilize sources of funds for the AMTP;
"source", or "patient" who has a sexually transmitted infection h. Mobilize its members to conduct monitoring and evaluation
(STI) including HIV, is given support in order to notify and advise of HIV- related programs, policies, and services within their
the partners that have been exposed to infection; mandate;
❖ Person Living with HIV (PLHIV): any individual diagnosed to be i. Coordinate, organize, and work in partnership with foreign
infected with HIV; and international organizations (funding, data collection,
❖ Pre-exposure Prophylaxis: use of prescription drugs as a research, and prevention and treatment modalities on HIV
strategy for the prevention of HIV infection by people who do not and AIDS) and ensure foreign funded programs are aligned
have the HIV and AIDS. It is an optional treatment, which may be to the national response;
taken by people who are HIV-negative but who have substantial, j. Advocate for policy reforms to Congress and other
higher-than-average risk of contracting an HIV infection; government agencies;
❖ Pre-test Counseling: process of providing an individual with k. Submit an annual report to the Office of the President,
information on the biomedical aspects of HIV AIDS, and emotional Congress, and the members of the Council;
support to any psychological implications of under going HIV l. Identify gaps in the national response on the part of
testing and the test result itself before the individual is subjected government agencies and its partners from civil society and
to the test; international organizations;
❖ Post-exposure Prophylaxis: preventive medical treatment m. Recommend policies and programs.
started immediately after exposure to pathogen (HIV) in order to

Page 3 of 6
[MTLB211] 2.02 “Republic Act No. 1116, Philippine HIV and AIDS Policy Act” I Prof. Sherlyn Joy P. Isip, RMT, MSMT
❖ Memberships and Composition: Protection of Human Rights
1. Department of Health (DOH);
2. Department of Education (DepEd); ❖ The country's response to the HIV and AIDS situation shall be
3. Department of Labor and Employment (DOLE); anchored on the principle of human rights and human dignity.
4. Department of Social Welfare and Development (DSWD); Public health concerns shall be aligned with internationally-
5. Department of the Interior and Local Government (DILG); recognized human rights instruments and standards.
6. Civil Service Commission (CSC); ❖ Towards this end, the members of the PNAC, in cooperation with
7. Commission on Higher Education (CHED); CSOs, and in collaboration with the Department of Justice (DOJ)
8. National Youth Commission (NYC); and the Commission on Human Rights (CHR), shall
9. Philippine Information Agency (PIA); (a) ensure the delivery of non-discriminatory HIV and AIDS
10. Department of Budget and Management; services by government and private HIV and AIDS
11. The Chairperson of the Committee on Health and (b) take the lead in developing redress mechanisms for PLHIV and
Demography of the Senate of the Philippines or his key affected populations to ensure that their civil, political,
representative; economic, and social rights are protected.
12. The Chairperson of the Committee on Health of the House of
Representative or his representative;
13-14. Two (2) representatives from organizations of persons Information, Education and Communication
living with HIV and AIDS;
15. One (1) representative from a private organization with ❖ Education in Learning Institutions: DepEd, CHED, and Technical
expertise in standard setting and service delivery; and Education and Skills Development Authority (TESDA)
16-21. Six (6) representatives from NGOs working for the welfare ➢ Basic and age-appropriate instruction on the causes, modes
or identified key populations. of transmission, and ways of preventing the spread of HIV
and AIDS and other STIs in their respective curricula taught
❖ Meeting: at least once every quarter in the presence of the in public and private learning institutions, including alternative
Chairperson or the Vice Chairperson, and at least ten (10) other and indigenous learning systems
members and/or permanent representatives ❖ Education for Parents and Guardians: DepEd in coordination with
❖ The Secretary of Health shall be the permanent Chairperson of parent-teacher organizations
the PNAC ➢ Conduct awareness-building seminars in order to provide
❖ The Vice Chairperson shall be elected from the government parents and guardians with a gender-responsive and age-
agency members and shall serve for a term of three (3) years. sensitive HIV and AIDS education
❖ Members representing CSOs shall serve for a term of three (3) ❖ Education as Right to Health and Information: HIV and AIDS
years renewable upon recommendation of the Council for a education and information dissemination shall form part of the
maximum of two (2) consecutive terms. constitutional right to health
❖ HIV and AIDS Information as a Health Service: HIV and AIDS
education and information dissemination shall form part of the
AIDS Medium Term Plan (AMTP)
delivery of health services by health practitioners, workers, and
personnel
❖ Latest: 2017 – 2022 ➢ The training of health workers shall include discussions on
❖ The PNAC shall formulate and periodically update the six (6)-year HIV-related ethical issues such as confidentiality, informed
AMTP, a national multi-sectoral strategic plan to prevent and consent, and the duty to provide treatment
control the spread of HIV and AIDS in the country. The AMTP shall ❖ Education in the Workplace: DOLE for the private sector, Civil
include the following: Service Commission for the public sector, and AFP and PNP for
the uniformed service shall implement this provision
(a) The country's target and strategies in addressing the HIV and ➢ Public and private employers and employees, members of
AIDS situation; the Armed Forces of the Philippine (AFP) and the Philippine
(b)The prevention, treatment care and support, and other National Police (PNP) shall be regularly provided with
components of the country's response; standardized basic information and instruction of HIV and
(c) The operationalization of the program and identification of the AIDS, including topics on confidentiality in the workplace and
government agencies responsible for implementing, overseeing, reduction or elimination of stigma and discrimination
coordinating, facilitating, and monitoring; ❖ Education for Filipinos Going Abroad: DOLE, Philippine Overseas
(d) The budgetary requirements and identify the sources of funds Employment Agency (POEA) and the Overseas Workers Welfare
for its implementation. Administration (OWWA), the Department of Foreign Affairs (DFA),
and the Commission on Filipino Overseas (CFO)
Role of Department of Health (DOH) ➢ Attend a seminar on the causes, manner of prevention, and
impact of HIV and AIDS, before being granted a certification
❖ The National HIV and AIDS and STI Prevention and Control for overseas assignment:
Program (NASPCP) of the DOH, which shall be composed of ▪ Information for Tourists and Transients: Philippine
qualified medical specialist and support personnel shall Information Agency, Department of Tourism (DOT) and
coordinate with the PNAC Department of Transportation (DOTr)
❖ The Epidemiology Bureau shall maintain a comprehensive HIV • Educational materials shall be adequately provided
and AIDS monitoring and evaluation program that shall serve the at all international and local ports of entry and exit.
following purposes: ▪ Education in Communities: DILG, the Union of Local
Authorities of the Philippines (ULAP), the League of
(a) Determine and monitor the magnitude and progression of HIV Provinces of the Philippines (LPP), the League of Cities
and AIDS in the Philippines of the Philippines (LCP), the League of Municipalities of
(b) Receive, collate, process, and evaluate all HIV-and-AIDS- the Philippines (LMP), and Liga ng mga Barangay sa
related medical reports from all hospitals, clinics, laboratories and Pilipinas through the Local AIDS Councils (LAC) or the
testing centers (it shall adopt a coding system that ensures local health boards, Local Council for the Protection of
anonymity and confidentiality) Children (LCPC), Sangguniang Kabataan and
(c) Submit, through its Secretariat, quarterly and annual reports to Association of Barangay Captains
the PNAC containing the findings of its monitoring and evaluation • Indigenous peoples communities and
activities in compliance with this mandate geographically isolated and disadvantaged areas

Page 4 of 6
[MTLB211] 2.02 “Republic Act No. 1116, Philippine HIV and AIDS Policy Act” I Prof. Sherlyn Joy P. Isip, RMT, MSMT
(GIDA) shall also be given due focus in the overseas workers, regardless of employment status and stage in
implementation of this section the migration process
• The DILG, DSWD and the NYC, shall also conduct ❖ Care and Support for Affected Families, Intimate Partners,
age-appropriate HIV and AIDS education for out-of- Significant Others and Children of People Living with HIV
school youth ❖ Care and Support Program in Prisons and Others Closed-Setting
Preventive Measures, Safe Practices and Procedures Institutions. All prisons, rehabilitation centers, and other closed-
setting institutions shall have comprehensive STI, HIV and AIDS
❖ The DOH shall establish a program to prevent mother-to-child HIV prevention and control program
transmission that shall be integrated in its maternal and child ❖ Non-discriminatory HIV and AIDS Services. Ensure the delivery of
health services non-discriminatory HIV and AIDS services by government and
❖ Standard Precaution on the Donation of Blood, Tissue, or Organ. private HIV and AIDS service providers
The DOH shall enforce the following guidelines on the donation of ❖ Protection of HIV Educators, Licensed Social Workers, Health
blood, tissue, or organ: Workers, and Other HIV and AIDS Service Providers from
Harassment. Any person involved in the provision of HIV and
(a) Donation of tissue or organ shall be accepted by a laboratory AIDS services, including peer educators, shall be protected from
or institution only after a sample from the donor has been tested suit, arrest or prosecution, and from civil, criminal or administrative
negative for HIV; liability, on the basis of their delivery of such services in HIV
(b) All donated blood shall also be subjected to HIV testing; prevention
(c) All donors whose blood, organ or tissue has been tested ❖ Health Insurance and Similar Health Services. The PhilHealth
positive shall be deferred from donation, notified of their HIV shall enforce confidentiality in the provision of these packages to
status, counselled, and referred for care and clinical management PLHIV. No PLHIV shall be denied or deprived of private health
as soon as possible; insurance under a Health Maintenance Organization (HMO) and
(d) Donations of blood, tissue, or organ testing positive for HIV private life insurance coverage under a life insurance company on
may be accepted for research purposes only, and shall be subject the basis of the person's HIV status. Furthermore, no person shall
to strict sanitary disposal requirements; and be denied of his insurance claims if he dies of HIV or AIDS under
(e) A second testing may be demanded as a matter of right by the a valid and subsisting life insurance policy
blood, tissue, or organ recipient or his/her immediate relatives
before transfusion or transplant, except during emergency cases. Confidentiality

Screening Test and Counseling ❖ The confidentiality and privacy of any individual who has been
tested for HIV, has been exposed to HIV, has HIV infection or HIV-
❖ As a policy, the State shall encourage voluntary HIV testing. and AIDS-related illnesses, or was treated for HIV-related
Written consent from the person taking the test must be obtained illnesses shall be guaranteed
before HIV testing ❖ Disclosure of Confidential HIV ad AIDS Information. It shall be
➢ Fifteen (15) to below eighteen (18) years of age, consent to unlawful to disclose, without written consent, information that a
voluntary HIV testing shall be obtained from the child without person has AIDS, has undergone HIV-related test, has HIV
the need of consent from a parent or guardian; infection or HIV-related illnesses, or has been exposed to HIV
➢ Young person aged below fifteen (15) who is pregnant or ❖ Disclosure of HIV-Related Test Results. Result of any test related
engaged in high-risk behavior shall be eligible for HIV testing to HIV shall be disclosed by the trained service provider who
and counseling, with the assistance of a licensed social conducts pre-test and post-test counseling only to:
worker or health worker ➢ individual who submitted to the test
➢ Consent to voluntary HIV testing shall be obtained from the ➢ patient is below fifteen (15) years old, an orphan, or is
child's parent or legal guardian if the person is below fifteen mentally incapacitated, the result may de disclose to either of
(15) years of age or is mentally incapacitated the patient's parents, legal guardian, or a duly assigned
❖ Compulsory HIV testing shall be allowed only in the following licensed social worker or health worker,
instances: ➢ person below fifteen (15) years of age and not suffering from
➢ To test a person who is charges with any of the offenses any mental incapacity, the result of the test shall be disclosed
punishable by law (serious and slight physical injuries, rape to child.
and simple seduction) ❖ Exceptions. Confidential HIV and AIDS information may be
➢ When it is necessary to resolve relevant issues under released by HIV testing facilities without consent in the following
Executive Order No. 209, otherwise known as "The Family instances:
Code of the Philippines" ➢ complying with reportorial requirements of the national active
➢ As a prerequisite in the donation of blood passive surveillance system of the DOH
➢ when informing other health workers directly involved in the
treatment or care of a PLHIV
Health and Support Services ➢ when responding to a subpoena duces tecum and subpoena
ad testificandum issued by a court
❖ Treatment of Persons Living with HIV and AIDS. The DOH shall
establish a program that will provide free and accessible ART and Discriminatory Acts and Practices and Corresponding
medication for opportunistic infections to all PLHIVs who are
Penalties
enrolled in the program
❖ Access to Medical Services by Indigents. Indigent persons living
with HIV shall not be deprived of access to medical services ❖ Discrimination in the Workplace: ejection of job application,
❖ Economic Empowerment and Support. PLHIV shall not be termination of employment, or other discriminatory policies in
deprives of any employment, livelihood, micro-finance, self-help, hiring, provision of employment and other related benefit,
and cooperative programs by reason of their HIV status promotion or assignment of an individual;
❖ Care and Support for Persons Living with HIV. Peer-led ❖ Discrimination in Learning Institution: refusal of admission,
counseling and support, social protection, welfare assistance, and expulsion, segregation, imposition of harsher disciplinary actions,
mechanisms for case management or denial of benefits or services of student or a prospective
❖ Overseas Workers Living with HIV. Develop a program to provide student;
a stigma-free comprehensive reintegration, care, and support ❖ Restriction on Travel and Habitation: restrictions on travel within
program, including economic, social, medical support for the Philippines, refusal of lawful entry to Philippine territory,
deportation from Philippines, or the quarantine or enforced
Page 5 of 6
[MTLB211] 2.02 “Republic Act No. 1116, Philippine HIV and AIDS Policy Act” I Prof. Sherlyn Joy P. Isip, RMT, MSMT
isolation of travelers is discriminatory. The same standard of Breaches Five (5) years and Three hundred fifty
protection shall be accorded to migrants, visitors, and residents confidentiality one (1) day to thousand
who are not Filipino citizens; (health seven (7) years pesos
❖ Restrictions on Shelter: restrictions on housing or lodging, professional, (P350,000.00) to
whether permanent or temporary; medical instructor, Five
❖ Prohibition on the right to seek an elective or appointive public worker, employer, hundred thousand
office; recruitment pesos
❖ Exclusion from Credit and Insurance Services: exclusion from agency, insurance (P500,000.00),
health, accident or life insurance, or credit and loan services, company,
including the extension of such loan or insurance facilities of an data encoder, and
individual; other custodian of
❖ Discrimination in Hospitals and Health Institutions: denial of health any medical
services, or being charges with a higher fee, on the basis of actual, record, file, data, or
perceived or suspected HIV status is discriminatory act and is test result)
prohibited;
❖ Denial of Burial Services: denial of embalming and burial services
for a decease person who had HIV and AIDS or who was known, On discriminatory Six (6) months to Fifty thousand
suspected, or perceived to be HIV-positive; acts and five (5) years pesos
❖ Bullying in all forms, including name-calling, upon a person based practices (P50,000.00) to Five
on actual, perceived, or suspected HIV status, including bullying hundred
in social media and other online portals thousand
(P500,000.00),
Penalties Obtained Face liability under Articles 19, 20, 21 and
knowledge of 26 of the new Civil Code
Imprisonment Fine confidential HIV and of the Philippines and relevant provisions of
Misinformation on One (1) year to ten Fifty thousand AIDS Republic Act No.
HIV and (10) years pesos information and 10173, otherwise known as the "Data
AIDS (50,000.00) to Five uses such Privacy Act of 2012".
hundred information to
thousand pesos malign or cause
(P500,000.00) damage injury, or
Negligence in the Six (6) to twelve (12) - loss to
practice of years, another person
profession suspension or ❖ The penalties collected shall be use for initial interventions
Compelled any revocation of required to address gaps in the national response on the part of
person to professional government agencies and its partners from civil society and
undergo HIV testing licenses international organizations
without
consent Administrative Order 2017-2019
On HIV and AIDS Six (6) months to One hundred “Policies and Guidelines in the Conduct of Human
service five (5) years thousand pesos Immunodeficiency Virus (HIV) Testing Services (HTS) in
providers from (P100,000.00) to Health Facilities”
harassment Five hundred
thousand pesos Operational Requirements for Facility-Based HIV Testing
(P500,000.00) Services
On health insurance Six (6) months to Not less than Fifty
and similar five (5) years, thousand ❖ Signed by : Paulyn Jean B. Rosell-Ubial, MD, MPH, CESO II
services suspensions or (P50,000.00) (Secretary of health) on September 15, 2017
revocation of ❖ HIV Testing services: full range of services accompanying HIV
business permit, testing including counselling; linkage to appropriate HIV
business prevention, treatment and care services and other clinical and
license or support services with coordination with reference laboratories to
accreditation, and support quality assurance and delivery of accurate results
professional license ❖ HIV testing services can be stand alone or integrated into existing
Breaches Six (6) months to Fifty thousand services of hospitals or clinics
confidentiality two (2) years pesos ❖ Only registered medical technologist with HIV proficiency training
(P50,000.00) to One shall perform the HIV test using Food and Drug Administration
hundred (FDA) registered test kits
fifty thousand pesos ❖ Reactive blood samples from clients/patients shall be sent to NRL-
(P150,000.00) SLH/SACCL (The National Reference Laboratory- San Lazaro
Hospital/STD AIDS Cooperative Central Laboratory) or its
Mass dissemination Two (2) years and One hundred fifty designated and certified confirmatory rapid HIV diagnostic
of the HIV one (1) day thousand algorithm (rHIVda) facility sites
status of a person to five (5) years pesos ❖ Reactive blood units (not person) from blood banks, samples shall
(spreading (P150,000.00) to be referred to the Research Institute for Tropical Medicine (RITM)
the information Three for confirmatory testing
online or hundred fifty
making statements thousand pesos
to the (P350,000.00)
media)

Page 6 of 6
RMT 2023 Republic Act No. 9288 “Act Promulgating a LEC
2020-2021
1ST SEM
OLFU MEDTECH Comprehensive Policy and a National System for MTLB

Ensuring Newborn Screening”


7 211

Transcriber: Riyoma Surell


❖ September 18, 1997
Outline ➢ Start of operation of the Newborn Screening Laboratory at
At the end of the session, the student must be able to learn: the National Institutes of Health, UP Manila
• Newborn Screening • Summary of R.A 9288 ❖ January 20, 2004
• Who may Collect • Declaration of Policy ➢ Issuance of the Presidential Proclamation No. 540,
Samples for Newborn • Elements of Newborn Subject: “Declaring the First Week of October of each year
Screening Screening as “National Newborn Screening Awareness Week”
• Epidemiology • Definition of Terms ❖ April 07, 2004
• Milestone in the • Newborn Screening ➢ Enactment of Republic Act 9288 known as the Newborn
Screening Act of 2004
History of Newborn • Implementation
❖ October 07, 2004
Screening in the • Newborn Screening
Philippines ➢ Signing of the Implementing Rules and Regulations of the
and Inherited
• Republic Act No. 9288 Newborn Screening Act
Metabolic Disorders
❖ January 2012
• General Information
➢ Inclusion of Maple Syrup Urine Disease (MSUD) in the NBS
Panel of Disorders
Newborn Screening ❖ December 2014
➢ Expanded Newborn Screening – inclusion of more than
➢ Process of collecting a few drops of blood from the newborn 20+ disorders in the NBS Panel of Disorders
onto an appropriate collection card and performing
biochemical testing for determining if the newborn has a Republic Act No. 9288
heritable condition
➢ Simple, non-invasive procedure to find-out if a baby has a
➢ “An Act Promulgating a Comprehensive Policy and a
congenital metabolic disorder that may lead to mental
National System for Ensuring Newborn Screening
retardation and or death if left untreated
▪ Appropriate specimen (manner of collection),
General Information
appropriate volume, proper labeling and transport
➢ Newborn screening tests are done by measuring metabolites
and enzyme activity in whole blood samples collected on ➢ Republic Act 9288
specialized filter paper ➢ Newborn Screening Act of 2004
➢ It is a simple procedure, using the heel prick method, a few ➢ Senate No. 2707 (February 2, 2004) and House No. 6625
drops of blood are blotted on a special absorbent filter (February 5, 2004)
card/paper ❖ Approval Date: April 7, 2004
❖ Signed by: President Gloria Macapagal-Arroyo
Who May Collect the Samples for Newborn Screening? ➢ Presidential Proclamation No. 540 on Jan 20, 2004:
“Newborn Screening Week”
❖ Physician
Summary of R.A 9288
❖ Nurse
❖ Midwife
❖ Medical Technologist ❖ Consists of 19 Sections
➢ Short Title, Declaration of Policy, Objectives, Definitions,
Epidemiology Obligation to Inform, Performance of Newborn Screening,
Refusal to be Tested, Continuing Education, Re-education
and Training Health Personnel, Licensing and Accreditation,
❖ 10.5 Million Screened
Lead Agency, Advisory Committee on Newborn Screening,
❖ 150, 000 Confirmed (+) for heritable conditions
Establishment and Accreditation of Newborn Screening
❖ Based on 2017
Centers, Establishment of a Newborn Screening Reference
Center, Quality Assurance, Database, Newborn Screening
Milestone in the History of Newborn Screening in the Fees, Repealing Clause, Separability Clause, Effectivity
Philippines ❖ Five Articles:
➢ General Provisions - Sections 1, 2, 3
❖ February 22, 1996 ➢ Definition of Terms - Section 4
➢ First organizational meeting attended by representatives ➢ Newborn Screening - Sections 5, 6, 7, 8, 9
from different PPS (Philippine Pediatric Society) and POGS ➢ Implementation - Sections 10, 11, 12, 13, 14, 15, 16
(Philippine Obstetrical and Gynecological Society) accredited ➢ Final Provisions - Sections 17, 18, 19
hospitals in Metro Manila
❖ April 02, 1996 Declaration of the Policy
➢ Creation of the NBS Study group composed of Pediatric and
OB-Gynecology consultants from participating hospitals ❖ It is the policy of the State to:
➢ Project name: Philippine Newborn Screening Project ➢ Protect and promote the right to health of the people,
including the rights of children to survival and full and healthy
❖ June 27, 1996 development as normal individuals
➢ Commencement of the Philippine Newborn Screening ▪ Based on the Bill of Rights (Article III) of the 1987
Project in 24 participating hospitals (18 private and 6 Constitution of the Philippines; Right to life and Right to
government) Health
❖ June 1996 – September 1997 ➢ Institutionalize a national newborn screening system that is
➢ Coordination with the New South Wales Newborn Screening comprehensive, integrative and sustainable, and will facilitate
Program in Australia for test performance and analysis collaboration
Page 1 of 5
[MTLB211] 2.03 “Republic Act No. 9288” I Prof. Sherlyn Joy P. Isip, RMT, MSMT
➢ The National Newborn Screening System shall ensure that ❖ Healthcare practitioner means physicians, nurses, midwives,
every baby born in the Philippines is offered the opportunity nursing aides and traditional birth attendants
to undergo newborn screening and thus be spared from ❖ Heritable condition means any condition that can result in mental
heritable conditions that can lead to mental retardation and retardation, physical deformity or death if left undetected and
death if undetected and untreated untreated and which is usually inherited from the genes of either
or both biological parents of the newborn
Elements of Newborn Screening ❖ NIH means the National Institute of Health
➢ NBS reference center (source of all info, confirmatory center)
❖ It is a requirement to institutionalize NBS as a public health ➢ Central facility within the NIH that is task/oversee as far as
program that aims to ensure that every child delivered is screened protocols, guidelines, trainings, updates, informational
from various heritable diseases that may lead to mental brochure content, and provide external QA (proficiency
retardation and worst-case scenario death testing – sort of accreditation) are concern, for accuracy
➢ Comprehensive (coherence of results)
➢ Integrative ➢ Repository source of testing database, case registries, etc.
➢ Sustainable ❖ Newborn means a child from the time of complete delivery to 30
➢ Collaborative days old
❖ Newborn Screening means the process of collecting a few drops
Objectives of blood from the newborn onto an appropriate collection card and
performing biochemical testing for determining if the newborn has
Government a heritable condition
❖ 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
❖ Parent education means the various means of providing parents
Newborn
or legal guardians information about newborn screening.
Screening
❖ 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
Health Care Practitioners Parent/ Guardian appropriate, provide treatment
❖ Treatment means the provision of prompt, appropriate and
adequate medicine, medical, and surgical management or dietary
➢ The Government will establish and integrate sustainable (no
prescription to a newborn for purposes of treating or mitigating the
period, continuous) NBS as part of public health delivery
adverse health consequences of the heritable condition
system (meaning everyone must afford)
➢ Practitioners as front liners/ middleman must know its
obligation: Newborn Screening
▪ To discuss the advantages of NBS, significance,
information and others crucial to understanding and ❖ Obligation to Inform
dissemination of the program ➢ Health practitioner: inform the parents or legal guardian of
➢ As part of responsible Parenthood, parents must recognize the newborn of the availability, nature and benefits of
their responsibilities in promoting child’s life and health from newborn screening prior to delivery
preventable disorders that can cause disability and death ➢ Department of Health (DOH): appropriate notification and
education regarding this obligation
Definition of Terms ❖ Performance of Newborn Screening
➢ Performed after twenty-four (24) hours of life but not later
than three (3) days from complete delivery of the newborn
❖ Comprehensive Newborn Screening System means a
➢ Newborn in intensive care: may be exempted from the 3-day
newborn screening system that includes, but is not limited to:
requirement but must be tested by seven (7) days of age
➢ education of relevant stakeholders;
➢ Joint responsibility of the parent(s) and the practitioner or
➢ collection and biochemical screening of blood samples taken
other person delivering the newborn to ensure that newborn
from newborns;
screening is performed
➢ 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;
➢ evaluation activities to assess long term outcome, patient
compliance and quality assurance
❖ 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
➢ Monitoring of newborn with heritable conditions, (+) after
diagnostic testing;
1. To ensure that the newborn patient complies fully with
the treatment intervention
2. To know whether there is a progression of disease and
whether effective treatment has been given ❖ When are newborn screening results available?
❖ Health institutions mean hospitals, health infirmaries, health ➢ 7 working days from the time samples are received.
centers, lying-in centers or puericulture centers with obstetrical ➢ Laboratory results indicating high risk to heritable diseases
and pediatric services, whether public or private that were screened (+) will be immediately communicated
and subjected within 24 hours for confirmatory test
Page 2 of 5
[MTLB211] 2.03 “Republic Act No. 9288” I Prof. Sherlyn Joy P. Isip, RMT, MSMT
❖ Refusal to be Tested: approved by the Committee upon the recommendation of the
➢ on the grounds of religious beliefs, but shall acknowledge in NIH
writing their understanding that refusal for testing places their ➢ No Newborn Screening Center shall be allowed to operate
newborn at risk for undiagnosed heritable conditions unless it has been duly accredited by the DOH based on the
➢ Refusal documentation shall be made part of the newborn's standards set forth by the Committee
medical record and refusal shall be indicated in the national ➢ Every Newborn Screening Center shall:
newborn screening database ▪ have a certified laboratory performing all tests included
❖ Continuing Education, Re-education and Training Health in the newborn screening program,
Personnel ▪ have a recall/follow up programs for infants found
➢ The DOH, with the assistance of the NIH and other positive for any and all of the heritable conditions;
government agencies, professional societies and non- ▪ be supervised and staffed by trained personnel who
government organizations, shall: have been duly qualified by the NIH;
▪ conduct programs for health personnel on the rationale, ▪ submit to periodic announced or unannounced
benefits, procedures of newborn screening inspections by the Reference Center in order to evaluate
▪ disseminate information materials on newborn and ensure quality Newborn Screening Center
screening at least annually to all health personnel performance
involved in material and pediatric care ❖ Establishment of a Newborn Screening Reference Center
❖ Licensing and Accreditation ➢ The NIH shall establish a Newborn Screening Reference
➢ The DOH and the Philippine Health Insurance Corporation Center, which shall be responsible for the national testing
(PHIC) shall require health institutions to provide newborn database and case registries, training, technical assistance
screening services as a condition for licensure or and continuing education for laboratory staff in all Newborn
accreditation Screening Centers
❖ Quality Assurance
Implementation ➢ The NIH Newborn Screening Reference Center shall be
responsible for drafting and ensuring good laboratory
❖ Lead Agency practice standards for newborn screening centers
➢ The DOH shall be the lead agency in implementing this act. ❖ Database
1. Establish the Advisory Committee on Newborn Screening; ➢ All Newborn Screening Centers shall coordinate with the NIH
2. Develop the implementing rules and regulations for the Newborn Screening Reference Center for consolidation of
immediate implementation of a nationwide newborn patient databases
screening program within one hundred eight (180) days from ➢ The NIH Newborn Screening Reference Center shall
the enactment of this Act; maintain a national database of patients tested and a registry
3. Coordinate with the Department of the Interior and Local for each condition.
Government (DILG) for implementation of the newborn ❖ Newborn Screening Fees
screening program; ➢ The PHIC shall include cost of newborn screening in its
4. Coordinate with the NIH Newborn Screening Reference benefits package
Center for the accreditation of Newborn Screening Centers ➢ To ensure sustainability of the National System for Newborn
and preparation of defined testing protocols and quality Screening, the newborn screening fee shall be divided and
assurance programs set aside for the following purposes:
❖ Advisory Committee on Newborn Screening ▪ (4%) to the DOH's Centers for Health Development to
➢ Integral part of the Office of the Secretary of the DOH be spent solely for follow-up services, education and
➢ Functions: other activities directly related to the provision of
1. review annually and recommend conditions to be newborn screening services
included in the newborn screening panel of disorders; ▪ (4%) to the Newborn Screening Centers for human
2. review and recommend the newborn screening fee to be resource development and equipment maintenance and
charged by Newborn Screening Centers; upgrading
3. review the report of the Newborn Screening Reference ▪ (4%) to the NIH Newborn Screening Reference Center
Center on the quality assurance of the National for overall supervision, training and continuing
Screening Centers and recommend corrective education, maintenance of national database, quality
measures as deemed necessary assurance program and monitoring of the national
❖ Advisory Committee on Newborn Screening program; and the balance for the operational and other
➢ Composition: expenses of the Newborn Screening Center
1. Chairman: Secretary of Health
2. Vice Chairperson: Executive Director of the NIH Newborn Screening and Inherited Metabolic Disorders
Members:
3. Undersecretary of the DILG; Bakit Kailangang magpa-NBS test ang inyong sanggol?
4. Executive Director of the Council for the Welfare of Kondisyong Epekto pag hindi na Epekto pag na-NBS
Children sinusuri NBS at nagamot kaagad
5. Director of the Newborn Screening Reference Center CH (Congenital Malubhang Mental Normal
6. - 8. Three (3) representatives appointed by the Hypothyroidisim) Retardation
Secretary of Health who shall be a pediatrician, CAH (Congenital Kamatayan Buhay at normal
obstetrician, endocrinologist, family physician, nurse or Adrenal Hyperplasia)
midwife, from either the public or private sector. GAL (Galactosemia) Kamatayan o Buhay at normal
➢ Term: three (3) representatives shall be appointed for a term Katarata
of three (3) years, subject to their being reappointed for PKU Malubhang Mental Normal
additional three (3) years period for each extension (Phenylketonuria) Retardation
➢ Meeting: At least twice a year. The NIH shall serve as the G6PD Deficiency Malubhang Anemia, Normal
Kernicterus
Secretariat of the Committee
MSUD (Maple Syrup Kamatayan Buhay at normal
❖ Establishment and Accreditation of Newborn Screening
Urine Disease)
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
Page 3 of 5
[MTLB211] 2.03 “Republic Act No. 9288” I Prof. Sherlyn Joy P. Isip, RMT, MSMT
➢ Phenylalanine to tyrosine
❖ Newborn Screening Facilities will offer NBS under two options: ▪ Phenylalanine hydroxylase
➢ Basic • Neurotoxic can cause brain damage expresses as
▪ Six-test Panel of Disorders mental retardation
• Congenital hypothyroidism (CH) • Effects normally seen within 6 months
• Congenital adrenal hyperplasia (CAH) • Mousy odor
• Galactosemia (GAL) • Poor learning abilities
• G6PD Deficiency (G6PDD) ➢ Mousy odor
• Phenylketonuria (PKU) ➢ Severe intellectual impairment, microcephaly, eczema,
• Maple syrup urine disease (MSUD) seizures, hypopigmentation, autistic behavior
➢ Expanded ❖ Screening: Guthrie test
▪ Newborn screening test ➢ Protein diet restriction
• Current panel of six (6) disorders
• Cystic fibrosis Maple Syrup Urine Disease
• Biotinidase disease
• Organic acid disorders ➢ Is an autosomal-recessive genetic disorder
• Fatty acid oxidation disorders where there is deficient or absence of
• Amino acid disorders production of enzyme branched chain alpha-
• Urea cycle disorder ketoacid decarboxylase
➢ Leucine, Isoleucine, Valine
• Hemoglobin disorders
➢ Maple syrup (Burnt sugar odor)
Congenital Hypothyroidism ➢ Lethargy, vomiting, lack of appetite, muscle
rigidity, respiratory irregularities, seizures, mental retardation
➢ Diet restriction
➢ Congenital means existing at birth ➢ Striking Feature
➢ Hypothyroidism is a condition where there is ▪ Urine, breath, skin
diminished production of thyroid hormones ▪ Accumulation of this branched chain AA and ketoacids
▪ Thyroid gland metabolites in blood urine CSF – encephalopathy,
• Butterfly shaped endocrine gland that progressive neurodegen as signs of failure or thrive
produces thyroid hormones like T3, T4
• Responsible for normal development and function Glucose-6-PD Deficiency
of certain body organs like bones, muscles, teeth
and particularly brain
➢ Is an inherited condition in which the body
➢ Jaundice, poor muscle tone, low body temperature, long-
lacks the enzyme G-6-PD which helps red
protruding tongue, large anterior fontanel, umbilical hernia
blood cells function normally
➢ Thyroid replacement
▪ Without the enzyme there is premature
➢ Treatment: L – thyroxine in tablet from normally crushed and
destruction of red cells
included in the meal
➢ Avoid: soy-based formulas and iron supplements – reduce
➢ Hemolytic anemia
absorption of thyroxine supplement
▪ Bacterial infections
▪ Viral infections
Congenital Adrenal Hyperplasia
▪ Analgesics, Antipyretics (aspirin)
▪ Antibiotics (Bactrim)
➢ Hyperplasia means increase in cell ▪ Anti-malarial drug (Chloroquine)Favism (soya food, fava
number beans)
➢ Organomegaly (enlargement) ▪ Naphthalene balls
▪ Due to deficiency of enzyme ➢ Lethargic, tachycardia, tachypnea, jaundice, splenomegaly,
paired glands that sit atop to the kidney – steroid tea-colored urine
hormones ➢ Blood transfusion, phototherapy, folic acid, limit exposure
➢ Inherited genetic disorders where there is deficient ➢ Intervention:
production of certain enzyme needed to produce adrenal ▪ Blood transfusion, phototherapy
hormones
➢ Cortisol, Aldosterone, Androgens, Catecholamines Galactosemia
▪ regulate metabolism
▪ helps in immunity
➢ An inherited disorder that lacks an enzyme
▪ regulates blood pressure
galactose-1-phosphate uridyl transferase
▪ maintenance of sexual characteristics
➢ Salt-wasting, dehydration, low BP, weight loss, listlessness,
▪ Galactose are not metabolized -> it will
drowsiness, metabolic acidosis, confusion, irritability, coma,
accumulated on the blood
abnormal genitalia
➢ Lactose – Glucose + Galactose
➢ Synthetic form of hydrocortisone, surgery
➢ Galactose
➢ 21-hydroxyllase deficiency
▪ Brain
▪ Eye
Phenylketonuria
➢ Hypoglycemic, failure to grow, poor weight, vomiting,
diarrhea, hepatomegaly, liver disease
➢ Is an autosomal recessive metabolic disorder in ➢ Avoid milk products, galactose restricted diet
which the body cannot properly use the essential amino
acid phenylalanine due enzyme deficiency
➢ Aminoacidopathies
▪ Class of inherited errors of metabolism in which
there is enzyme defect that inhibits body’s ability to
metabolize certain AA

Page 4 of 5
[MTLB211] 2.03 “Republic Act No. 9288” I Prof. Sherlyn Joy P. Isip, RMT, MSMT

Terminology from Draft GHR Condition Name


Report
Organic Acid Disorders (9)
IV A Isovaleric acidemia
GA I Glutaric academia (type I)
HMG 3-hydroxy-3methylglutaryl
coenzyme A lyase deficiency
MCD Multiple carboxylase deficiency
MUT Methylmalonic acidemia
Cbl A,B Methylmalonic acidemia
3MCC 3-methylcrotonyl coenzyme A
deficiency
PROP Propionic acidemia
BKT Beta-ketothiolase deficiency
Fatty Acid Oxidation
Disorders (5)
MCAD Medium-chain acyl coenzyme A
dehydrogenase deficiency
VLCAD Very long-chain acyl coenzyme
A dehydrogenase deficiency
LCHAD Long-chain 3-hydroxyacyl
coenzyme A dehydrogenase
deficiency
TFP Mitochondrial trifunctional
protein deficiency
CUD Carnitine update disorder
Amino Acid Disorders (6)
PKU Phenylketonuria
MSUD Maple syrup urine disease
HCY Homocystinuria
CIT Citrullinemia
ASA Argininosuccinic acidemia
TYR I Tyrosinemia
Hemoglobinopathies (3)
Hb SS Sickle cell anemia
Hb S/Bth Discussed in HBB gene
summary
Hb S/C Discussed in HBB gene
summary
Other (6)
CH Congenital hypothyroidism
BIOT Biotinidase deficiency
CAH 21-hydroxylase deficiency
GALT Galactosemia
HEAR (a hearing test for Nonsyndromic deafness,
hearing loss) syndromic deafness disorders
CF Cystic fibrosis

Page 5 of 5
💼
Week 8: Republic Act No. 11166 “Philippine
HIV and AIDS Policy Act”

Republic Act No. 11166


“Philippine HIV and AIDS Policy Act”

INTRODUCTION TO HIV AND AIDS

Human Immunodeficiency Virus (HIV): the virus, of the type called retrovirus, which infects cells of the human
immune system, and destroys or impairs the cells' function. Infection
with HIV results in the progressive deterioration of the immune system. Leading to immune deficiency.

Acquired Immune Deficiency Syndrome (AIDS): deficiency of immune system that stems from infection with the
Human Immunodeficiency Virus or HIV, making an individual susceptible to opportunistic infections.

CD4 500 CD4 200 CD4 50

Bacterial infections
Pneumocystis carinii
Tuberculosis (TB)
Toxoplasmosis Disseminated Mycobacterium avium (MAC) infection
Herpes Simplex
Cryptococcosis Histoplasmosis CMV retinitis CNS lymphoma
Herpes Zoster
Coccidiodomycosis Progressive multifocal leukoencephalopathy HIV
Vaginal candidiasis
Cryptosporiosis Non- dementia
Hairy leukoplakia
Hodgkin’s lymphoma
Kaposi’s sarcoma

MODE OF TRANSMISSION

YOU CAN GET HIV VIA...

sex without condom

Passed from mother to baby

Sharing injecting equipment

Contaminated blood transfusions and Organ transplants

YOU CAN GET HIV FROM...

Kissing

Hugging

Sharing food

Insect bites

Toilet seats

Bathing

Sneezes and Coughs

Sweat

PRIMARY PREVENTION

Week 8: Republic Act No. 11166 “Philippine HIV and AIDS Policy Act” 1
FIVE WAYS TO PROTECT YOURSELF

Abstinence

Monogamous Relationship

Protected Sex

Sterile needles

New shaving/cutting blades

Prevention is better than cure. Especially when something has no cure.

You cannot prevent or cure HIV by:

1. Washing after sex

2. Sex with virgin

3. Pulling out method

4. Spells and herbal medicines

5. Using contraceptive pills

Condoms and PrEP used correctly and consistentl protect you from HIV transmission during
sex.

HIV TESTING

Any laboratory procedure done on any individual to determine the presence or absence of HIV infection

WINDOW PERIOD: refers to the period of time, usually lasting from two weeks to six (6) months during which an
infected individual will test "negative" upon HIV testing but can actually transmit the infection.

Screening Test (HIV-1 & HIV-2)

Confirmatory Test

BLOOD DETECTION TESTS

TESTS REMARKS

HIV enzyme-linked immunosorbent assay (ELISA) Screening test for HIV Sensitivity > 99.9%

Western blot Confirmatory test Specificity > 99.9% (when combined with ELISA)

HIV rapid antibody test Screening test for HIV Simple to perform

Predictor of HIV progression Risk of opportunistic infections and


Absolute CD4 lymphocyte count
AIDS when <200
Best test for diagnosis of acute HIV infection Correlates with
HIV viral load tests
disease progression and response to HAART

ANTI-RETROVIRAL DRUGS

Nucleoside Reverse Transcriptase inhibitors: Azidothymidine (Zidovudine)

Non-Nucleoside Transcriptase inhibitors: Viramune (Nevirapine)

Protease inhibitors: Norvir (Ritonavir)

Week 8: Republic Act No. 11166 “Philippine HIV and AIDS Policy Act” 2
DIFFERENCES : HIV 1 and HIV 2
HIV-1

Found around the world

Immunodeficiency is faster

Shorter incubation period

Highly infectious in early stages (increase risk of transmission)

HIV-2

West Africa: Increasing cases in the US

Immunodeficiency develops more slowly

Longer incubation period

Less infectious in early stages; Much infectious as the virus develops.

EPIDEMIOLOGY OF HIV WORLDWIDE


Number of people living with HIV in 2020

East and southern Africa - 20.6 million

Western and Central Africa - 7.7 million

Asia and Pacific - 5.8 million

W. and C. Europe and N. America - 2.2 million

Latin America - 2.1 million

East Europe and Central Asia - 1.6 million

Caribbean- 330,000

Middle East and North Africa - 230, 000

REPUBLIC ACT NO.11166


PHILIPPINE HIV AND AIDS POLICY ACT”

GENERAL INFORMATION

RA 8504: “Philippine AIDS Prevention and Control Act of 1998”

Consists of 9 articles

With 52 sections

Approved on February 13, 1998 by President Fidel V. Ramos

RA 11166: "Philippine HIV and AIDS Policy Act”

The newest law passed by the legislative department to modify certain provision of the original version to be more
effective in dealing HIV condition in the Philippine setting.

Week 8: Republic Act No. 11166 “Philippine HIV and AIDS Policy Act” 3
An act strengthening the Philippine Comprehensive Policy on HIV/AIDS prevention, treatment, care, and support, and,
reconstituting the Philippine National Aids Council (PNAC), repealing for the purpose Republic Act No. 8504

Consists of 8 articles

With 57 sections

Approved on December 20, 2018 by President Rodrigo R. Duterte

DECLARATION OF POLICIES

Responding to the country's HIV and AIDS shall be anchored on the principles of human rights upholding human
dignity.

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

Respect, protect, and promote human rights as the cornerstones of an effective response to the country's HIV and
AIDS situation.

HIV and AIDS education and information dissemination should form part the right to health.

Inclusion and participation of persons directly and indirectly affected by the HIV and AIDS situation, especially
persons living with HIV, are crucial in eliminating the virus.

Confidentiality and non-compulsory nature of HIV testing and HIV- related testing shall always be guaranteed and
protected.

Ensure the delivery of non-discriminatory HIV and AIDS services.

Develop redress mechanisms for persons living with HIV to ensure that their civil, political, economic, and social rights
are protected.

Accordingly, the State shall:


(a) Establish policies and programs to prevent the spread of HIV and deliver treatment, care, and support services
to Filipinos living with HIV.
(b) Adopt a multi-sectoral approach in responding to the country's HIV and AIDS situation by ensuring that the whole
government approach, local communities, civil society organizations (CSOs), and persons living with HIV are at the center
of the process
(c) Ensure access to HIV- and AIDS-related services by eliminating he climate of stigma and discrimination.
(d) Positively address and seek to eradicate conditions that aggravated the spread of HIV infection (poverty, gender
inequality, marginalization, and ignorance).

DEFINITION OF TERMS

Anti-retroviral Therapy (ART): treatment that stops or suppresses viral replication or replications of a retrovirus like
HIV, thereby slowing down the progression of infection;

Bullying: severe or repeated use by one or more persons of a written, verbal or electronic expression, or a physical
act of gesture, directed at another person in reasonable fear of physical or emotional harm or damage to one's
property; creating a hostile environment; infringing on the rights; or materially and substantially disrupting the
processes or orderly operation of an institution or organization;

Civil Society Organizations (CSOs): groups of nongovernmental and noncommercial individuals or legal entities;

Compulsory HIV Testing: HIV testing imposed upon an individual characterized by lack of consent, use of force or
intimidation, the use of testing as a prerequisite for employment or other purposes, and other circumstances when
informed choice is absent;

Discrimination: unfair or unjust treatment that distinguishes, excludes, restricts, or shows preferences (sex gender,
age, sexual orientation, gender identity and expression, economic status, disability, ethnicity, and HIV status) which
has the purpose or effect of nullifying or impairing the recognition, enjoyment or exercise by all persons
similarly situated, of all their rights and freedoms;

Gender Expression: the way a person communicates gender identity to others through behavior, clothing, hairstyles,
communication or speech pattern, or body characteristics;

Week 8: Republic Act No. 11166 “Philippine HIV and AIDS Policy Act” 4
Gender Identity: personal sense of identity as characterized, among others, by manner of clothing, inclinations, and
behavior in relation to masculine or feminine conventions. A person may have a male or female identity with the
physiological characteristics of the opposite sex;

Health Maintenance Organizations (HMO): juridical entities legally organized to provide or arrange for the provision
of pre-agreed or designated health care services to its enrolled members for a fixed pre-paid fee for a specified period
of time;

High-risk Behavior: person's involvement in certain activities that


increase the risk of transmitting or acquiring HIV;

HIV Counseling: interpersonal and dynamic communication process between a client and a trained counselor, whose
objective in counseling is to encourage the client to explore important personal issues, identify ways of coping with
anxiety and stress, and plan for the future (keeping healthy, adhering to treatment, and preventing transmission); and
in the context of a negative HIV test result, to encourage the client to explore motivations, options, and skills to stay
HIV-negative;

HIV and AIDS Counselor: any individual trained by an institution or organization accredited by the Department of
Health (DOH) to provide counseling services on HIV and AIDS with emphasis on behavior modification;

HIV and AIDS Monitoring: documentation and analysis of the number of HIV and AIDS infections and the pattern of
its spread;

HIV and AIDS Prevention and Control: measures aimed at protecting non-infected persons from contracting HIV
and minimizing the impact of the condition on persons living with HIV;

HIV-Negative: absence of HIV or HIV antibodies upon HIV testing;

HIV-Positive: refers to the presence of HIV infection as documented by the presence of HIV and HIV antibodies in
the sample being tested;

HIV Testing: any facility-based, mobile medical procedure, or community-based screening modalities that are
conducted to determine the presence or absence of HIV in a person's body.

HIV Testing Facility: DOH accredited on-site or mobile testing center, hospital, clinic, laboratory, and other facility
that has the capacity to conduct voluntary HIV counseling and HIV testing;

Informed Consent: 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;

Laboratory: area or place, including community-based settings, where research studies are being undertaken to
develop local evidence for effective HIV response;

Mature Minor Doctrine: legal principle that recognizes the capacity of some minors to consent independently to
medical procedures, if they have been assessed by qualified health professionals to understand the nature of
procedures and their consequences to make a decision on their own;

Medical Confidentiality: core duty of medical practice where the information provided by the patient to health
practitioner and his/her health status is kept private and is not divulged to third parties. The patient's health status can
however, be shared with:

other medical practitioner involved in the professional care of the patient

attending physician, consulting medical specialist, nurse and medical technologist

all other health workers or personnel involved in any counseling, testing or professional care of the patient

Opportunistic infections: illnesses caused by various organism, many of which do not cause diseases in persons
with healthy immune system;

Partner Notification: process by which the "index client", "source", or "patient" who has a sexually transmitted
infection (STI) including HIV, is given support in order to notify and advise the partners that have been exposed to
infection;

Person Living with HIV (PLHIV): any individual diagnosed to be infected with HIV;

Pre-exposure Prophylaxis: use of prescription drugs as a strategy for the prevention of HIV infection by people who
do not have the HIV and AIDS. It is an optional treatment, which may be taken by people who are HIV-negative but
who have substantial, higher-than-average risk of contracting an HIV infection;

Pre-test Counseling: process of providing an individual with information on the biomedical aspects of HIV AIDS, and
emotional support to any psychological implications of under going HIV testing and the test result itself before the
individual is subjected to the test;

Week 8: Republic Act No. 11166 “Philippine HIV and AIDS Policy Act” 5
Post-exposure Prophylaxis: preventive medical treatment started immediately after exposure to pathogen (HIV) in
order to prevent infection by the pathogen and the development of the disease;

Post-test Counseling: process of providing risk-reduction information and emotional support to a person who
submitted to HIV testing at the time the result is released;

Prophylactic refers to any agent or device used to prevent the transmission of an infection;

Redress: refers to an act of compensation for unfairness, grievance, and reparation;

Sexually Transmitted Infections (STIs): infections that are spread through the transfer of organisms from one
person to another as a result of sexual contact;

Sexual Orientation: direction of emotional, sexual attraction, or conduct towards people of the same sex
(homosexual orientation) or towards people of both sexes (bisexual orientation) or towards people of the opposite sex
(heterosexual orientation) or to the absence of sexual attraction (asexual orientation);

Stigma: dynamic devaluation and dehumanization of an individual in the eyes of others

Treatment hubs: private and public hospitals or medical establishments accredited by the DOH to have the capacity
and facility to provide treatment and care services to PLHIV;

Voluntary HIV testing: HIV testing done on an individual who, after having undergone pre-test counseling willingly
submits to such test;

Vulnerable communities: communities and groups suffering from vulnerabilities such as unequal opportunities,
social exclusion, poverty, unemployment, and other similar social exclusion, making them more susceptible to HIV
infection and to developing AIDS; and

Workplace: office, premise or work site where workers are habitually employed and shall include the office or place
where workers regularly report for assignment in the course of their employment.

THE PHILIPPINE NATIONAL AIDS COUNCIL

Philippine National AIDS Council (PNAC) was established to ensure the implementation of the country's response
to the HIV and AIDS situation. It shall be an agency attached to the DOH.

Functions:

(a) Develop the AIDS Medium Term Plan (AMTP) in collaboration with relevant government agencies, CSOs, the
PLHIV community;

(b) Ensure the operationalization and implementation of the AMTP;

(c) Strengthen the collaboration between government agencies and CSOs;

(d) Develop and ensure the implementation of the guidelines and policies provided in this Act;

(e) Monitor the progress of the response to the country's HIV and AIDS
situation;

(f) Monitor the implementation of the AMTP

(g) Mobilize sources of funds for the AMTP;

(h) Mobilize its members to conduct monitoring and evaluation of HIV- related programs, policies, and services
within their mandate;

(i) Coordinate, organize, and work in partnership with foreign and international organizations (funding, data
collection, research, and prevention and treatment modalities on HIV and AIDS) and ensure foreign funded
programs are aligned to the national response;

(j) Advocate for policy reforms to Congress and other government agencies;

(k) Submit an annual report to the Office of the President, Congress, and the members of the Council;

(l) Identify gaps in the national response on the part of government agencies and its partners from civil society
and international organizations;

(m) Recommend policies and programs.

Memberships and Composition:

Week 8: Republic Act No. 11166 “Philippine HIV and AIDS Policy Act” 6
(1) Department of Health (DOH);
(2) Department of Education (DepEd);
(3) Department of Labor and Employment (DOLE);
(4) Department of Social Welfare and Development (DSWD);
(5) Department of the Interior and Local Government (DILG);
(6) Civil Service Commission (CSC);
(7) Commission on Higher Education (CHED);
(8) National Youth Commission (NYC);
(9) Philippine Information Agency (PIA);
(10) Department of Budget and Management;
(11) The Chairperson of the Committee on Health and Demography of the Senate of the Philippines or his representative;
(12) The Chairperson of the Committee on Health of the House of Representative or his representative;
(13-14) Two (2) representatives from organizations of persons living with HIV and AIDS;
(15) One (1) representative from a private organization with expertise in standard setting and service delivery; and
(16-21) Six (6) representatives from NGOs working for the welfare or identified key populations.

Meeting: at least once every quarter in the presence of the Chairperson or the Vice Chairperson, and at least ten
(10) other members and/or permanent representatives.

The Secretary of Health shall be the permanent Chairperson of the PNAC.

The Vice Chairperson shall be elected from the government agency members and shall serve for a term of three (3)
years.

Members representing CSOs shall serve for a term of three (3) years renewable upon recommendation of the
Council for a maximum of two (2) consecutive terms.

AIDS MEDIUM TERM PLAN (AMTP)

The PNAC shall formulate and periodically update the six (6)-year AMTP, a national multi-sectoral strategic plan to
prevent and control the spread of HIV and AIDS in the country. The AMTP shall include the following.

(a) The country's target and strategies in addressing the HIV and AIDS situation;

(b)The prevention, treatment care and support, and other components of the country's response;

(c) The operationalization of the program and identification of the


government agencies responsible for implementing, overseeing,
coordinating, facilitating, and monitoring;

(d) The budgetary requirements and identify the sources of funds for its implementation.

ROLE OF DEPARTMENT OF HEALTH

The National HIV and AIDS and STI Prevention and Control Program (NASPCP) of the DOH, which shall be
composed of qualified medical specialist and support personnel shall coordinate with the PNAC.

The Epidemiology Bureau shall maintain a comprehensive HIV and AIDS monitoring and evaluation program that
shall serve the following purposes:

(a) Determine and monitor the magnitude and progression of HIV and AIDS in the Philippines

(b) Receive, collate, process, and evaluate all HIV-and-AIDS-related medical reports from all hospitals, clinics,
laboratories and testing centers (it shall adopt a coding system that ensures anonymity and confidentiality)

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

PROTECTION OF HUMAN RIGHTS

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

Towards this end, the members of the PNAC, in cooperation with CSOs, and in collaboration with the Department of
Justice (DOJ) and the Commission on Human Rights (CHR), shall:

Week 8: Republic Act No. 11166 “Philippine HIV and AIDS Policy Act” 7
(a) ensure the delivery of non-discriminatory HIV and AIDS services by government and private HIV and AIDS
service provider

(b) take the lead in developing redress mechanisms for PLHIV and key affected populations to ensure that their
civil, political economic, and social rights are protected.

INFORMATION, EDUCATION AND COMMUNICATION

Education in Learning Institutions: DepEd, CHED, and Technical Education and Skills Development Authority
(TESDA)

Basic and age-appropriate instruction on the causes, modes of transmission, and ways of preventing the spread
of HIV and AIDS and other STIs in their respective curricula taught in public and private learning institutions,
including alternative and indigenous
learning systems.

Education for Parents and Guardians: DepEd in coordination with parent-teacher organizations

Conduct awareness-building seminars in order to provide parents and guardians with a gender-responsive and
age-sensitive HIV and AIDS education.

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

HIV and AIDS Information as a Health Service: HIV and AIDS education and information dissemination shall form
part of the delivery of health services by health practitioners, workers, and personnel.

The training of health workers shall include discussions on HIV-related ethical issues such as confidentiality,
informed consent, and the duty to provide treatment.

Education in the Workplace: DOLE for the private sector, Civil Service Commission for the public sector, and AFP
and PNP for the uniformed service shall implement this provision.

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

Education for Filipinos Going Abroad: DOLE, Philippine Overseas Employment Agency (POEA) and the
Overseas Workers Welfare Administration (OWWA), the Department of Foreign Affairs (DFA), and the
Commission on Filipino Overseas (CFO)

Attend a seminar on the causes, manner of prevention, and impact of HIV and AIDS, before being granted a
certification for overseas assignment.

Information for Tourists and Transients: Philippine Information Agency, Department of Tourism (DOT) and
Department of Transportation (DOTr)

Educational materials shall be adequately provided at all international and local ports of entry and exit.

Education in Communities: DILG, the Union of Local Authorities of the Philippines (ULAP), the League of
Provinces of the Philippines (LPP), the League of Cities of the Philippines (LCP), the League of Municipalities
of the Philippines (LMP), and Liga ng mga Barangay sa Pilipinas through the Local AIDS Councils (LAC) or the
local health boards, Local Council for the Protection of Children (LCPC), Sangguniang Kabataan and
Association of Barangay Captains

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

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

PEVENTIVE MEASURES, SAFE PRACTICES AND PROCEDURES

The DOH shall establish a program to prevent mother-to-child HIV transmission that shall be integrated in its
maternal and child health services.

Standard Precaution on the Donation of Blood, Tissue, or Organ. The DOH shall enforce the following guidelines on
the donation of blood, tissue, or organ:

Week 8: Republic Act No. 11166 “Philippine HIV and AIDS Policy Act” 8
(a) 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;

(b) All donated blood shall also be subjected to HIV testing;

(c) All donors whose blood, organ or tissue has been tested positive shall be deferred from donation, notified of
their HIV status, counselled, and referred for care and clinical management as soon as possible;

(d) Donations of blood, tissue, or organ testing positive for HIV may be accepted for research purposes only,
and shall be subject to strict sanitary disposal requirements; and

(e) A second testing may be demanded as a matter of right by the blood, tissue, or organ recipient or his/her
immediate relatives before transfusion or transplant, except during emergency cases.

SCREENING, TESTING AND COUNSELING

As a policy, the State shall encourage voluntary HIV testing. Written consent from the person taking the test
must be obtained before HIV testing.

Fifteen (15) to below eighteen (18) years of age, consent to voluntary HIV testing shall be obtained from the child
without the need of consent from a parent or guardian;

Young person aged below fifteen (15) who is pregnant or engaged in high-risk behavior shall be eligible for HIV
testing and counseling, with the assistance of a licensed social worker or health worker.

Consent to voluntary HIV testing shall be obtained from the child's parent or legal guardian if the person is below
fifteen (15) years of age or is mentally incapacitated.

Compulsory HIV testing shall be allowed only in the following instances:

To test a person who is charges with any of the offenses punishable by law (serious and slight physical injuries,
rape and simple seduction)

When it is necessary to resolve relevant issues under Executive Order No. 209, otherwise known as "The Family
Code of the Philippines"

As a prerequisite in the donation of blood

HEALTH AND SUPPORT SERVICES

Treatment of Persons Living with HIV and AIDS. The DOH shall establish a program that will provide free and
accessible ART and medication for opportunistic infections to all PLHIVs who are enrolled in the program.

Access to Medical Services by Indigents. Indigent persons living with HIV shall not be deprived of access to
medical services.

Economic Empowerment and Support. PLHIV shall not be deprives of any employment, livelihood, micro-finance,
self-help, and cooperative programs by reason of their HIV status.

Care and Support for Persons Living with HIV. Peer-led counseling and support, social protection, welfare
assistance, and mechanisms for case management.

Overseas Workers Living with HIV. Develop a program to provide a stigma-free comprehensive reintegration, care,
and support program, including economic, social, medical support for overseas workers, regardless of employment
status and stage in the migration process.

Care and Support for Affected Families, Intimate Partners, Significant Others and Children of People Living
with HIV.

Care and Support Program in Prisons and Others Closed-Setting Institutions. All prisons, rehabilitation centers,
and other closed-setting institutions shall have comprehensive STI, HIV and AIDS prevention and control program.

Non-discriminatory HIV and AIDS Services. Ensure the delivery of non-discriminatory HIV and AIDS services by
government and private HIV and AIDS service providers.

Protection of HIV Educators, Licensed Social Workers, Health Workers, and Other HIV and AIDS Service
Providers from Harassment. Any person involved in the provision of HIV and AIDS services, including peer
educators, shall be protected from suit, arrest or prosecution, and from civil, criminal or administrative liability, on the
basis of their delivery of such services in HIV prevention.

Week 8: Republic Act No. 11166 “Philippine HIV and AIDS Policy Act” 9
Health Insurance and Similar Health Services. The PhilHealth shall enforce confidentiality in the provision of these
packages to PLHIV. No PLHIV shall be denied or deprived of private health insurance under a Health Maintenance
Organization (HMO) and private life insurance coverage under a life insurance company on the basis of the person's
HIV status. Furthermore, no person shall be denied of his insurance claims if he dies of HIV or AIDS under a valid and
subsisting life insurance policy.

CONFIDENTIALITY

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

Disclosure of Confidential HIV and AIDS Information. It shall be unlawful to disclose, without written consent,
information that a person has AIDS, has undergone HIV-related test, has HIV infection or HIV-related illnesses, or has
been exposed to HIV.

Disclosure of HIV-Related Test Results. Result of any test related to HIV shall be disclosed by the trained service
provider who conducts pre-test and post-test counseling only to:

individual who submitted to the test patient is below fifteen (15) years old, an orphan, or is mentally incapacitated,
the result may de disclose to either of the patient's
parents, legal guardian, or a duly assigned licensed social worker or health worker,

person below fifteen(15) years of age and not suffering from any mental incapacity, the result of the test shall be
disclosed to child.

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

complying with reportorial requirements of the national active passive surveillance system of the DOH

when informing other health workers directly involved in the treatment or care of a PLHIV

when responding to a subpoena duces tecum and subpoena ad testificandum issued by a court

DISCRIMINATORY ACTS AND PRACTICES AND CORRESPONDING PENALTIES

Discrimination in the Workplace: ejection of job application, termination of employment, or other discriminatory
policies in hiring, provision of employment and other related benefit, promotion or assignment of an individual;

Discrimination in Learning Institution: refusal of admission, expulsion, segregation, imposition of harsher


disciplinary actions, or denial of benefits or services of student or a prospective student;

Restriction on Travel and Habitation: restrictions on travel within the Philippines, refusal of lawful entry to Philippine
territory, deportation from Philippines, or the quarantine or enforced isolation of travelers is discriminatory. The same
standard of protection shall be accorded to migrants, visitors, and residents who are not Filipino citizens;

Restrictions on Shelter: restrictions on housing or lodging, whether permanent or temporary;

Prohibition on the right to seek an elective or appointive public office;

Exclusion from Credit and Insurance Services: exclusion from health, accident or life insurance, or credit and loan
services, including the extension of such loan or insurance facilities of an individual;

Discrimination in Hospitals and Health Institutions: denial of health services, or being charges with a higher fee,
on the basis of actual, perceived or suspected HIV status is discriminatory act and is prohibited;

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

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

PENALTIES

IMPRISONMENT FINE

Fifty thousand pesos (50,000.00) to Five


Misinformation on HIV and AIDS One (1) year to ten (10) years
hundred thousand pesos (P500,000.00)

Week 8: Republic Act No. 11166 “Philippine HIV and AIDS Policy Act” 10
IMPRISONMENT FINE

Six (6) to twelve (12) years, suspension


Negligence in the practice of profession
or revocation of professional licenses
Compelled any person to undergo HIV Six (6) to twelve (12) years, suspension
testing without consent or revocation of professional licenses
One hundred thousand pesos
On HIV and AIDS service providers
Six (6) months to five (5) years (P100,000.00) to Five hundred
from harassment
thousand pesos (P500,000.00)
Six (6)months to five (5) years,
On health insurance and similar suspensions or revocation of business Not less than Fifty thousand
services permit, business license or (P50,000.00)
accreditation, and professional license
Fifty thousand pesos (P50,000.00) to
Breaches confidentiality Six (6) months to two (2) years One hundred fifty thousand pesos
(P150,000.00)
Mass dissemination of the HIV status of
One hundred fifty thousand pesos
a person (spreading the information Two (2) years and one (1) day to five (5)
(P150,000.00) to Three hundred fifty
online or making statements to the years
thousand pesos (P350,000.00)
media)
Breaches confidentiality (health
professional, medical instructor, worker,
employer, recruitment agency, Five (5) years and one (1) day to seven
insurance company, data encoder, and (7) years
other custodian of any medical record,
file, data, or test result)
Fifty thousand pesos (P50,000.00) to
On discriminatory acts and practices Six (6) months to five (5) years
Five hundred thousand (P500,000.00),
Face liability under Articles 19, 20, 21 Face liability under Articles 19, 20, 21
Obtained knowledge of confidential HIV and 26 of the new Civil Code of the and 26 of the new Civil Code of the
and AIDS information and uses such Philippines and relevant provisions of Philippines and relevant provisions of
information to malign or cause damage Republic Act No.10173, otherwise Republic Act No.10173, otherwise
injury, or loss to another person known as the "Data Privacy Act of known as the "Data Privacy Act of
2012". 2012".

The penalties collected shall be use for initial interventions required to address gaps in the national response on the part
of government agencies and its partners from civil society and international organizations.

Administrative Order 2017-0019


“Policies and Guidelines in the Conduct of Human Immunodeficiency Virus (HIV) Testing Services (HTS) in Health
Facilities”

OPERATIONAL REQUIREMENTS FOR FACILITY-BASED HIV TESTING SERVICES

Signed by : Paulyn Jean B. Rosell-Ubial, MD, MPH, CESO II (Secretary of health) on September 15, 2017

HIV Testing services: full range of services accompanying HIV testing including counselling; linkage to appropriate
HIV prevention, treatment and care services and other clinical and support services with coordination with reference
laboratories to support quality assurance and delivery of accurate results.

HIV testing services can be stand alone or integrated into existing services of hospitals or clinics.

Only registered medical technologist with HIV proficiency training shall perform the HIV test using Food and
Drug Administration (FDA) registered test kits.

Reactive blood samples from clients/patients shall be sent to NRL- SLH/SACCL (The National Reference
Laboratory- San Lazaro Hospital/ STD AIDS Cooperative Central Laboratory) or its designated and certified
confirmatory rapid HIV diagnostic algorithm (rHIVda) facility sites.

Reactive blood units (not person) from blood banks, samples shall be referred to the Research Institute for
Tropical Medicine (RITM) for confirmatory testing.

Week 8: Republic Act No. 11166 “Philippine HIV and AIDS Policy Act” 11
FLOW CHART OF HIV/AIDS REPORTING SYSTEM

Week 8: Republic Act No. 11166 “Philippine HIV and AIDS Policy Act” 12
💼
Week 9: Republic Act No. 9288: Newborn
screening
REPUBLIC ACT NO. 9288
“AN ACT PROMULGATING A COMPREHENSIVE POLICY AND A NATIONAL SYSTEM FOR ENSURING
NEWBORN SCREENING”

What is Newborn Screening?

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.

Simple, non-invasive procedure to find-out if a baby has a congenital metabolic disorder that may lead to mental
retardation and or death if left untreated. Newborn screening tests are done by measuring metabolites and enzyme
activity in whole blood samples collected on specialized filter paper.

It is a simple procedure, using the heel prick method, a few drops of blood are blotted on a special absorbent filter
card/paper.

WHO MAY COLLECT THE SAMPLES FOR NEWBORN SCREENING?

Physician

Nurse

Midwife

Medical Technologist

DOH Newborn Screening Program

Newborn screening (NBS) is an essential public health strategy that enables the early detection and
management of several congenital disorders, which if left untreated, may lead to mental retardation and/or death.

Early diagnosis and initiation of treatment, along with appropriate long-term care help ensure normal growth and
development of the affected individual.

It has been an integral part of routine newborn care in most developed countries for five decades, either as a
health directive or mandated by law. In the Philippines, it is a service available since 1996.

Vision:
Every Filipino child will be born healthy and well, with an inherent right to life, endowed with human dignity and reaching
her/his potential with the right opportunities and accessible resources.
Mission:
To ensure that all Filipino children will have access to and avail of total quality care for the optimal growth and
development of their full potential.
Goal:
By 2030, all Filipino newborns are screened and properly managed for common and rare congenital disorders to reduce
preventable deaths of newborn.

EPIDEMIOLOGY

Globally 2.4 million children died in the first month of life in 2020.

Week 9: Republic Act No. 9288: Newborn screening 1


There are approximately 6,700 newborn deaths every day, amounting to 47% of all child deaths under the age of 5
years.

Philippines: 12.6

lower bound: 8.9

Upper bound: 17.7

Table 1. Milestones in the History of Newborn Screening in the Philippines

February 22, First organizational meeting attended by representatives from different PPS and POGS accredited hospitals in Metro
1996 Manila
Creation of the NBS Study group composed of Pediatric and OB-Gynecology consultants from participating hospitals.
April 02, 1996
Project name: Philippine Newborn Screening Project
Commencement of the Philippine Newborn Screening Project in 24 participating hospitals (18 private and 6
June 27, 1996
government)
June 1996 –
Coordination with the New South Wales Newborn Screening Program in Australia for test performance and analysis
September 1997
September 18,
Start of operation of the Newborn Screening Laboratory at the National Institutes of Health, UP Manila
1997
Inclusion of the Newborn Screening Program in Child Health 2025, a planning framework on children’s health of the
March 1999
Department of Health with the ultimate goal of achieving good health for all Filipino children by the year 2025
Creation of the Inter-agency Task Force on Newborn Screening composed of representatives from DOH as Chair,
July 30, 1999 Institute of Human Genetics-National Institutes of Health, UP Manila, DILG, midwives’ association, and other health
groups
January 03, Issuance of Administrative Order # 1-A s 2000 by the Department of Health stating the Policies for the Nationwide
2000 Implementation of Newborn Screening
Newborn Screening Study Group declared as Outstanding Health Research Awardee (OHRA) by the Philippine
July 19, 2000
Council for Health Research and Development
Issuance of Department Order No. 29-C s 2001 by DOH, Subject: “Creation of the National Technical Working Group
February 07, on Newborn Screening Program under the National Center for Disease Prevention and Control”. The group was
2001 tasked to provide direction and guidance for the nationwide implementation of the NBS program (see Annex B). DO
29-C s 2001 has been amended by DPO 2005-1660 to reconstitute the NTWG membership
February 21, First National Awarding Ceremonies for the Outstanding Achievers in the Implementation of Newborn Screening
2003 sponsored by DOH and NIH
Canadian International Development Agency (CIDA) awards a financial grant to the Institute of Human Genetics to
May 01, 2003 intensify promotional and advocacy work on newborn screening in Regions 4, 6, 10, with funds allocated for the
writing of a Manual of Operations for newborn screening
December 09, Issuance of DOH Administrative Order No 121, s 2003, Subject: “Strengthening Implementation of the National
2003 Newborn Screening System”
January 20, Issuance of the Presidential Proclamation No. 540, Subject: “Declaring the First Week of October of each year as
2004 “National Newborn Screening Awareness Week”
April 07, 2004 Enactment of Republic Act 9288 known as the Newborn Screening Act of 2004

October 07,
Signing of the Implementing Rules and Regulations of the Newborn Screening Act
2004
December 02,
Opening of the 2nd Newborn Screening Center in Visayas at West Visayas State University Medical Center
2005
January 22, Inclusion of NBS in the licensing requirement of Philippine hospitals; 90% of NBS fee covered by national health
2006 insurance [PhilHealth]
January 02,
Opening of Scholarships for Genetics and Endocrinology for regions without specialists
2007

December 2007 Inclusion of Newborn Screening in the PhilHealth Newborn Care Package (NCP)

June 12, 2008 Issuance of DOH Memo No. 2009 – 0123 imposing the following targets: 30% - 2008, 50% - 2009 and 85% by 2010

June 28, 2008 Creation of the NTWG Panel of Expert Committees

Issuance of AO No. 2008 – 0026 and 2008 - 0026A by DOH imposing penalties for non-implementation and/or
August 08, 2008
overpricing of NBS

Week 9: Republic Act No. 9288: Newborn screening 2


February 22, First organizational meeting attended by representatives from different PPS and POGS accredited hospitals in Metro
1996 Manila

May 20, 2009 Setting up of additional G6PD Confirmatory Centers

July 7, 2009 Creation of the National Newborn Screening Follow-up Committee (NNSFC)

Opening of the 3rd Newborn Screening Center in Mindanao at the Southern Philippines Medical Center (formerly
October 5, 2009
Davao Medical Center)
October 2010 Opening of the 4th Newborn Screening Center at the Angeles University Foundation Medical Center Central Luzon

February 2011 Creation of the Committee on Storage, Use and Disposal of the Residual Dried Blood Spots (DBS)

Initial offering of the MS Genetic Counseling Program by the Philippine General Hospital (PGH) – Department of
June 2011
Pediatrics and UP Manila College of Medicine
January 2012 Inclusion of Maple Syrup Urine Disease (MSUD) in the NBS Panel of Disorders

Opening of the 5th NSC in Region 4A (CALABARZON) at Daniel O. Mercado Medical Center in Tanauan City,
September 2013
Batangas
May 2014 Setting up of Continuity Clinics in different parts of the Country

December 2014 Expanded Newborn Screening – inclusion of more than 20+ disorders in the NBS Panel of Disorders

May 2017 Opening of the 6th NSC in Northern Luzon at the Mariano Marcos Memorial Hospital and Medical Center

January 2019 Full coverage of expanded newborn screening in the PhilHealth Newborn Care Package

Opening of the 7th NSC in Central Visayas at the Eversley Childs Sanitarium and General Hospital (ECSGH) in
February 2020
Jagobiao, Mandaue City, Cebu

REPUBLIC ACT NO. 9288

“AN ACT PROMULGATING A COMPREHENSIVE POLICY AND A


NATIONAL SYSTEM FOR ENSURING NEWBORN SCREENING”

GENERAL INFORMATION

Republic Act 9288

Newborn Screening Act of 2004

Senate No. 2707 (February 2, 2004) and House No. 6625 (February 5, 2004)

Approval Date: April 7, 2004

Signed by: President Gloria Macapagal-Arroyo

Presidential Proclamation No. 540 on Jan 20, 2004: “Newborn Screening


Week”

SUMMARY OF RA 9288

Consists of 19 Sections

Short Title, Declaration of Policy, Objectives, Definitions, Obligation to Inform, Performance of Newborn
Screening, Refusal to be Tested, Continuing Education, Re-education and Training Health Personnel, Licensing
and Accreditation, Lead Agency, Advisory Committee on Newborn Screening, Establishment and Accreditation of
Newborn Screening Centers, Establishment of a Newborn Screening Reference Center, Quality Assurance,
Database, Newborn Screening Fees, Repealing Clause, Separability Clause,
Effectivity

Five Articles

General Provisions - Sections 1, 2, 3

Definition of Terms - Section 4

Newborn Screening - Sections 5, 6, 7, 8, 9

Implementation - Sections 10, 11, 12, 13, 14, 15, 16

Final Provisions - Sections 17, 18, 19

Week 9: Republic Act No. 9288: Newborn screening 3


DECLARATION OF THE 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.

Institutionalize a national newborn screening system that is comprehensive, integrative and sustainable, and will
facilitate collaboration.

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.

ELEMENTS OF NEWBORN SCREENING

It is a requirement to institutionalize NBS as a public health program that aims to ensure that every child delivered is
screened from various heritable diseases that may lead to mental retardation and worst-case scenario death.

1. Comprehensive

2. Integrative

3. Sustainable

4. Collaborative

OBJECTIVES

NEWBORN SCREENING

GOVERNMENT

PARENT / GUARDIAN

HEALTH CARE PRACTITIONERS

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.

DEFINITION OF TERMS

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;

Week 9: Republic Act No. 9288: Newborn screening 4


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;

evaluation activities to assess long term outcome, patient compliance and quality assurance.

Follow-up means the monitoring of a newborn with a heritable condition for the purpose of ensuring that the newborn
patient complies fully with the medicine or dietary prescriptions.

Health institutions mean hospitals, health infirmaries, health centers, lying-in centers or puericulture centers with
obstetrical and pediatric services, whether public or private.

Healthcare practitioner means physicians, nurses, midwives, nursing aides and traditional birth attendants.

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.

NIH means the National Institute of Health

Newborn means a child from the time of complete delivery to 30 days old.

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.

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.

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

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.

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.

Obligation to Inform

Health practitioner: inform the parents or legal guardian of the newborn of the availability, nature and benefits of
newborn screening prior to delivery

Department of Health (DOH): appropriate notification and education regarding this obligation

Performance of Newborn Screening

Performed after twenty-four (24) hours of life but not later than three (3) days from complete delivery of the
newborn.

Newborn in intensive care: may be exempted from the 3-day requirement but must be tested by seven (7) days of
age.

Joint responsibility of the parent(s) and the practitioner or other person


delivering the newborn to ensure that newborn screening is performed.

Newborn screening sample obtained at the birthing center

Sample sent to the laboratory for NBS analysis

NEGATIVE RESULT - No further follow-up is required

Follow-up testing is normal. Baby is not at increased risk to have an inherited metabolic disease.

POSITIVE RESULT - Further follow-up testing is required

Follow-up testing reveals that the baby has a specific disorder. Treatment is started immediately.

Week 9: Republic Act No. 9288: Newborn screening 5


When are newborn screening results available?

7 working days from the time samples are received.

Laboratory results indicating high risk to heritable diseases that were screened (+) will be immediately communicated
and subjected within 24 hours for confirmatory test.

Refusal to be Tested:

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.

Refusal documentation shall be made part of the newborn's medical record and refusal shall be indicated in the
national newborn screening database.

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 programs for health personnel on the rationale, benefits, procedures of newborn screening

(ii) disseminate information materials on newborn screening at least annually to all health personnel involved in
maternal and pediatric care.

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.

IMPLEMENTATION
Lead Agency

The DOH shall be the lead agency in implementing this act.

1. Establish the Advisory Committee on Newborn Screening;

2. Develop the implementing rules and regulations for the immediate


implementation of a nationwide newborn screening program within one hundred 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.

Advisory Committee on Newborn Screening

Integral part of the Office of the Secretary of the DOH

Functions:

1. review annually and recommend conditions to be included in the


newborn screening panel of disorders;

2. review and recommend the newborn screening fee to be charged by


Newborn Screening Centers;

3. 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.

Composition:

1. Chairman: Secretary of Health

Week 9: Republic Act No. 9288: Newborn screening 6


2. Vice Chairperson: Executive Director of the NIH
Members:

3. Undersecretary of the DILG

4. Executive Director of the Council for the Welfare of Children

5. Director of the Newborn Screening Reference Center

6-8. 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.

Term: 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.

Meeting: At least twice a year. The NIH shall serve as the Secretariat of the
Committee.

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.

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;

(iv) submit to periodic announced or unannounced inspections by the


Reference Center in order to evaluate and ensure quality Newborn Screening Center performance.

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.

Quality Assurance

The NIH Newborn Screening Reference Center shall be responsible for drafting and ensuring good laboratory practice
standards for newborn screening centers

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.

Newborn Screening Fees

The PHIC shall include cost of newborn screening in its benefits package.

To ensure sustainability of the National System for Newborn Screening, the newborn screening fee shall be divided
and set aside for the following purposes:

(4%) to the DOH's Centers for Health Development to be spent solely for
follow-up services, education and other activities directly related to the provision of newborn screening services

(4%) to the Newborn Screening Centers for human resource development and equipment maintenance and
upgrading

Week 9: Republic Act No. 9288: Newborn screening 7


(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.

NEWBORN SCREENING AND INHERITED METABOLIC DISORDERS

Bakit kailangan magpa-NBS test ang inyong sanggol?

Epkto pag HINDI na NBS Epekto pag na-NBS at nagamot kaagad

CH - congenital Hypothyrodism Malubhang mental retardation Normal

CAH - congenital adrenal hyperplasia Kamatayan Buhay at Normal

GAL o Galactosemia Kamatayan o katarata Buhay at Normal

PKU - phenylketonuria Malubhang Anemia, Retardation Normal

G6PD Deficiency Malubhang Anemia, Kernicterus Normal

MSUD - mapple syrup urine disease Kamatayn Buhay at normal

EXPANDED NEW BORN SCREENING


New born screening facilities will offer NBS under two (2) options:

1. Basic - six-test panel of disorders

2. Expanded - newborn screening test

Inquire at any newborn screening Facility

private hospitals, private lying in, government hospitals and lying-ins.

Week 9: Republic Act No. 9288: Newborn screening 8


What’s NEW with EXPANDED NBS

ENBS allows the detection of more genetic disorders

6 - basic

Congenital hypothyroidism (CH)

Congenital adrenal hyperplasia (CAH)

Galactosemia (GAL)

G6PD Deficiency (G6PDD)

Phenylketonuria (PKU)

Maple Syrup Urine Disease (MSUD)

28 - expanded

Current panel for the six (6) +

Cystic Fibrosis

Biotinidase Disease

Organic acid disorders

Fatty acidd oxidation disorders

Amino acid disorders

Urea Cycle Disorder

Hemoglobin disorder

How much is EXPANDED NBS?

BASIC EXPANDED

PRICE 550 PESOS 1500 PESOS

FACILITY COLLECTION FEE 50 PESOS 50 PESOS

TOTAL 600 PESOS 1550 PESOS

How about PHILHEALTH COVERAGE?

at present, there has been no changes in the amount covered for newborn screening in the Philhealth Newborn Care
Package

PHILHEALTH PACKAGE: 550php both for basic and expanded.

Week 9: Republic Act No. 9288: Newborn screening 9


CONGENITAL HYPOTHYROIDISM

The most common etiology of CH is thyroid dysgenesis (TD): absent thyroid, ectopic or hypoplastic thyroid. In
rare cases, CH results from mutations in the genes that control thyroid gland development including thyroid
transcription factor (TTF- 2) and pairedbox-8 protein (PAX-8 ).

Rapid detection by newborn screening, prompt confirmatory testing and Levothyroxine administration can prevent
severe mental retardation and impaired growth due to CH.

CONGENITAL ADRENAL HYPERPLASIA

Congenital Adrenal Hyperplasia (CAH) is a group of disorders resulting from enzymatic defects in the biosynthesis of
steroids.

There are many enzymes involved in the synthesis of adrenal hormones but in about 90% of CAH, it is due to 21-
hydroxylase deficiency. Others are due to cholesterol desmolase 11β-hydroxylase deficiency, 17β-
hydroxylase deficiency and 3β-hydroxysteroid dehydrogenase.

All forms of CAH are inherited in an autosomal recessive pattern.

The mainstay of treatment in CAH is glucocorticoid and mineralocorticoid replacement therapy which corrects the
cortisol deficiency and reverses the abnormal hormonal patterns.

PHENYLKETONURIA

Phenylketonuria (PKU) is a disorder of aromatic amino acid metabolism in which phenylalanine cannot be converted
to tyrosine due to a deficiency or absence of the enzyme phenylalanine hydroxylase.

The odor of the phenylketonuric patient is that of phenylacetic acid described as mousy, barny, or musty.

Dietary management is key to treatment like complete avoidance of food containing high amounts of phenylalanine.

MAPLE SYRUP URINE DISEASE

Maple syrup urine disease (MSUD) is due to a defect or deficiency of the


branched chain ketoacid dehydrogenase complex in which elevated quantities of leucine, isoleucine, valine, and their

Week 9: Republic Act No. 9288: Newborn screening 10


corresponding oxoacids accumulate in body fluids. The increase in leucine may cause competitive inhibition with other
precursors of neurotransmitters causing the neurologic manifestations.

Long term treatment of MSUD is based on dietary restriction of branched-


chain amino acids and supplementation of thiamine if proven beneficial; valine and isoleucine supplementation is also
recommended.

GLUCOSE-6-PD DEFICIENCY

G6PD-deficiency is an X-linked disorder found in both sexes but more males are affected.

The most common clinical manifestation of G6PD deficiency is hemolytic anemia induced by various oxidative
stresses.

Other associated disorders to G6PD deficiency are decreased RBC lifespan and cataract formation.

There is no cure for G6PD deficiency, but the main goal in the management is avoidance of oxidative insults [bacterial
infections, viral infections, analgesics, antipyretics (aspirin), antibiotics (bactrim), anti-malarial drug (chloroquine),
favism (soya food, fava beans), naphthalene balls] and blood transfusions for acute hemolytic crisis.

GALACTOSEMIA

Galactosemia is a rare genetic metabolic disorder that is inherited in an autosomal recessive manner. It is an inborn
error of carbohydrate metabolism characterized by elevated levels of galactose and its metabolites due to enzyme
deficiencies involved in its metabolism.

Dietary elimination of milk and milk products containing lactose is the treatment for all types of galactosemia. There is
no chemical or drug substitute for the missing enzyme at this time.

FAQ’s
What is newborn screening?

Newborn Screening (NBS) is a simple procedure to find out if your baby has a congenital disorder that may lead to
mental retardation or even death if left untreated.

What is Expanded Newborn Screening (ENBS)?

The expanded newborn screening program increased the screening panel of disorders from six (6) to more than
twenty-eight.

Why is it important?

Most babies with metabolic disorders look “normal” at birth. By doing ENBS, metabolic disorders may be detected
even before clinical signs and symptoms are present. As a result of this, treatment can be given early to prevent
consequences of untreated conditions.*

When is it done?

ENBS is ideally done immediately after 24 hours from birth.

How is it done?

A few drops of blood are taken from the baby’s heel, blotted on a special absorbent filter card and then sent to
Newborn Screening Center (NSC).

Who will collect the sample for ENBS?

The blood sample for ENBS may be collected by any of the following: physician, nurse, medical technologist or
trained midwife.

Where is ENBS available?

ENBS is available in hospitals, lying-ins, rural health units, health centers and some private clinics.

How much is ENBS?

Expanded newborn screening costs ₱1750 and is included in the Newborn Care Package (NCP) for PhilHealth
members.

What is Newborn Care Package?

Week 9: Republic Act No. 9288: Newborn screening 11


NCP is a PhilHealth benefit package for essential health services of the newborn during the first few days of life. It
covers essential newborn care, expanded newborn screening, and hearing screening tests.

What are the eligibility conditions for newborn to avail of the NCP?
Newborns are eligible for NCP if ALL of the following are met:

Either of the parents are eligible to avail of the benefits,

Born in accredited facilities that perform deliveries, such as hospitals and birthing homes; and

Services were availed of upon delivery.

How can results be claimed?

Results can be claimed from the health facility where ENBS was availed. Normal ENBS results are available by 7 - 14
working days from the time samples are received at the NSC.

Positive ENBS results are relayed to the parents immediately by the health facility. Please ensure that the address
and phone number you will provide to the health facility are correct.

What is the meaning of the newborn screening result?

A NEGATIVE SCREEN means that the ENBS result is normal.

A POSITIVE SCREEN means that the newborn must be brought back to his/her health practitioner for further testing.

What must be done when a baby has a positive ENBS result?

Babies with positive results must be referred at once to a specialist for confirmatory testing and further management.

What happens to the dried blood samples after screening?

After the dried blood spot has been tested, it will be stored in a secure locked area. The stored sample is retained to
allow for normal quality assurance and may be used for ethics committee approved researches for the benefit of the
public.

Week 9: Republic Act No. 9288: Newborn screening 12


REPUBLIC ACT NO. 7719 “National Blood Services Act of 1994”

WORLD BLOOD DONOR DAY REPUBLIC ACT NO. 7719


World Blood Donor Day takes place on June SECTION I. TITLE
14 each year. The aim is to raise global awareness of
the need for safe blood and blood products for • This act shall be known as the “National Blood
transfusion and of the critical contribution Services Act of 1994”
voluntary, unpaid blood donors make to national
• An act promulgating voluntary blood donation,
health systems.
providing for an adequate supply of safe blood,
The day also provides an opportunity to call
regulating blood banks and providing penalties for
to action to governments and national health
violation thereof.
authorities to provide adequate resources and put
into place systems and infrastructures to increase the -Safe blood- contains no transmissible diseases
collection of blood from voluntary, non-remunerated
blood donor. • Approved in May 5, 1994 by Pres. Fidel V. Ramos

• Of the 118.5 million blood donations collected SECTION II. DECLARATION OF POLICIES
globally, 40% of these are collected in high-income
countries, home to 16% of the world’s population • To promote and encourage voluntary blood
donation by the principle that blood donation is a
• An increase of 7.8 million blood donations from humanitarian act
voluntary unpaid donors has been reported from 2013 to
2018. In total, 79 countries collect over 90% of their blood • To lay down the legal principle of blood transfusion
supply from voluntary unpaid blood donors; however, 56 is a professional medical service and not a sale of a
countries collect more than 50% of their blood supply commodity
from family/replacement or paid donors.
-Considered as professional medical service
• The Department of Health (DOH) finally realized
its goal of collecting one (1) million blood units from the • To provide adequate, safe, affordable and
total population; two decades after the National Blood equitable distribution of supply of blood and blood
Services Act of 1994 (Republic Act No. 7719) was signed products
into law.
-Before commercial blood banks exist but this law
• Last December 2017, the country’s goal to aims to remove all commercial blood banks and all
obtain the 1% (1 million blood units) blood collection from
shall operate as charitable.
the total population was achieved and collected 1,120,408
blood units. This represents a significant contribution to SECTION II. DECLARATION OF POLICIES
the global call for a 100% voluntary blood donation by the
World Health Organization. • To inform the public of the voluntary blood
donation to curb hazards caused by the commercial
sale of blood
REPUBLIC ACT NO. 7719 “National Blood Services Act of 1994”
• To teach the benefits and rationale in the existing SECTION III. DEFINITIONS
health subjects of the formal education systems and
non-formal education systems • Blood/blood product – refers to human blood,
processed or unprocessed and includes blood
-Blood donations must be promoted in schools and components, its products and derivatives;
universities
-whole blood, packed RBCs, platelet concentrate,
• To mobilize all the sectors of the community to fresh-frozen plasma, cryoprecipitate
participate in mechanisms for voluntary and non-
profit collection of blood • Blood bank/center – a laboratory or institution
with the capability to recruit and screen blood
• To mandate the DOH to establish and organize a donors, collect, process, store, transport and issue
National Blood Transfusion Service Network blood for transfusion and provide information and/
Service Network- Availability of different blood in or education on blood transfusion transmissible
different blood banks. Wherein the lack of blood diseases;
supply in one blood bank can be supplied by another -all services are included starting from donor
one. screening up to education of blood transfusion
• Assistance to institution promoting voluntary blood transmissible diseases
donation providing non-profit blood services • Commercial blood bank – a blood bank that exists
-System of reimbursement of the cost to patients for profit;
who can afford to pay or from government. -does not exist anymore
• To require all blood collection units and blood • Hospital-based blood bank – a blood bank which is
banks/centers to operate a non-profit basis located within the premises of a hospital, and which
-Non-business entity, tax-exempted, charitable can perform compatibility testing of blood;

• To establish scientific and professional standards -Located in hospitals, cross-matching to the recipient
for the operation of blood collection units and blood • Blood collection unit – an institution or facility duly
bank/centers authorized by the Department of Health to recruit
• To regulate and ensure the safety of all activities and screen donors and collect blood;
related to the collection, storage and banking of -Limited only to the donor screening and collection of
blood blood. Collected blood unit will be transferred to
-Control the blood transfusion transmissible diseases blood banks
such as HIV and parasitic infection as malaria and • Voluntary blood donor – one who donates blood on
syphilis even hepatitis B. one’s own volition or initiative and without monetary
compensation;
• Upgrading of blood banks/centers for preventive
services and education • Department – the Department of Health;
REPUBLIC ACT NO. 7719 “National Blood Services Act of 1994”
• Blood transfusion transmissible diseases – >Required by the DECS (Department of Education,
diseases which may be transmitted as a result of Culture and Sports) in the inclusion of non-formal
blood transfusion, including AIDS, Hepatitis-B, education curricula
Malaria and Syphilis;
c. Professional Education
• Secretary of Health – the Secretary of Health or >Continuing medical education, trainings on the
any other person to whom the Secretary delegates rational use of blood products including merits of
the responsibility of carrying out the provisions of voluntary blood donation
this Act; and
-Agencies associated on continuing medical
• Walking Blood Donor – an individual included in professionals are the following:
the list of qualified voluntary blood donors referred
 Department of Health(DOH)
to in Section 4, paragraph (e), who is ready to donate
blood when needed in his/her community.  Philippine Blood Coordinating Council (PBCC)
 Philippine Society of Hematology and Blood
-Their name is registered in the community. Transfusion
Whenever blood is needed they could be called and  Philippine Medical Association
would agree to donate.  PAMET
 Philippine Nurses Association
SECTION IV. PROMOTION OF
VOLUNTARY BLOOD DONATION d. Establishment of Blood Services Network
> Blood Centers shall be strategically established
• In order to ensure adequate supply of human in every province and city nationwide
blood, a voluntary blood donation shall be promoted
> The promotion of blood collection in schools,
through the following:
business enterprises, barangay and military camps
a. Public Education shall be promoted
> Organized and sustained nationwide public
-Agencies that handles the establishment of blood
education campaign by the Department, the
services network are DOH and Philippine National
Philippine National Red Cross (PNRC) and the
Red Cross(NGO)
Philippine Blood Coordinating Council (PBCC), set
aside funds and generate financial support for all e. Walking Donors
sectors. > In areas where there may be inadequate blood
banking facilities, the walking blood donor concept
-We should inform the public
shall be encouraged and all government hospitals,
b. Promotion in Schools rural-health units, health centers and barangays in
> Benefits and rationale of voluntary blood these areas shall be required to keep at all times a
donation shall be included and given emphasis in list of qualified blood donors with their specified
health subjects of schools, both public and private, at blood typing.
the elementary, high school and college levels.
SECTION V. NATIONAL VOLUNTARY
BLOOD SERVICES PROGRAM
REPUBLIC ACT NO. 7719 “National Blood Services Act of 1994”
• A program to meet an evolutionary manner, needs • BLOOD SHALL BE COLLECTED FROM
for blood transfusion in all region of the country. HEALTHY VOLUNTARY DONORS ONLY!
• Funds for this purpose shall be provided by the • While donated blood is free, there are significant
government through the following institutions: costs associated with collecting, testing, preparing
• PCSO (P25,000,000.00) components, labeling, storing and shipping;
recruiting and educating donors; and quality
• PAGCOR (P25,000,000.00) assurance. As a result, processing fees are charged to
recover costs. Processing fees for individual blood
• Duty Free Shop (P20,000,000.00)
components vary considerably.
• Other contributions form other agencies such as
• The following are acceptable maximum allowable
civic organization
processing fee for blood/components: Whole blood:
SECTION VI. UPGRADING OF SERVICES Php 1,500.00; Pack Red Cells: Php 1,100.00; Fresh
Frozen Plasma: Php 700.00; Cryoprecipitate: Php
AND FACILITIES 700.00; and Cryosupernate: Php 700.00. (AO 181 s.
• All blood banks/centers shall provide preventive 2002).
health services such as education and counseling on • Hospitals charge for any additional testing that may
blood transfusion transmittable diseases. be required, such as the crossmatch, as well as for
• All government hospitals shall be required to the administration of the blood.
establish voluntary blood donation programs and
SECTION IX. REGULATION OF BLOOD
private hospitals are encourage to establish the said
program also. SERVICES

SECTION VII. PHASE-OUT OF • It shall be unlawful for any person to establish and
operate a blood banks/centers unless it is registered
COMMERCIAL BLOOD BANKS and issued a license to operate by the Department
• All commercial blood banks shall be phased-out • No license shall be granted or renewed by the
over a period of two (2) years after effectivity of this Department for the establishment and operation
Act. unless it complies with the standards prescribed by
• Extended to a maximum period of two (2) years by the Department
the Secretary. • No license shall be granted or renewed by the
Department for the establishment and operation of a
SECTION VIII. NON-PROFIT OPERATION blood bank/center unless it complies with the
• All blood banks/centers shall operate on a non- standards prescribed by the Department.
profit basis; Provided, that they may collect service • Such blood bank/center shall be under the
fee not greater than the maximum prescribe by the
management of a licensed and qualified physician
Department.
duly authorized by the Department.
REPUBLIC ACT NO. 7719 “National Blood Services Act of 1994”
SECTION X. IMPORTATION OF BLOOD Any blood bank/center which shall collect charges
and fees greater than the maximum prescribed by
BANK, EQUIPMENT, BLOOD BAGS AND the Department shall have its license suspended or
REAGENTS revoked by the Secretary.

• Equipment, blood bags and reagents used for the • IMPRISONMENT: not less than one (1) month nor
screening and testing donors, collection and more than six (6) months
processing and storage of blood shall be imported
• FINE: not less than Five thousand pesos (P5,000)
tax- and duty-free by the PNRC (Philippine National
nor more than Fifty thousand pesos (P50,000)
Red Cross) , blood banks and hospitals participating
actively in the National Voluntary Blood Services Any person who shall establish and operate a blood
Program. bank without securing any license to operate from
the Department or who fails to comply with the
• This provision shall be implemented by the rules
standards prescribed by the Department referred to
and regulations to be promulgated by the
in Section 9
Department in consultation and coordination with
the Department of Finance. • IMPRISONMENT: not less than twelve (12) years
and one (1) day nor more than twenty (20) years
SECTION XI. RULES AND REGULATION
• FINE: not less than Fifty thousand pesos (P50,000)
• The existing Revised Rules and Regulations nor more than Five hundred thousand pesos
Governing the Collection, Processing and Provision of (P500,000)
Human Blood and the Establishment and Operation
of Blood Banks shall remain in force unless amended • The Secretary may impose administrative sanctions
or revised by the Secretary but not limited to fines, suspension, or revocation of
license to operate a blood banks/centers and to
-Revised rules and regulations contains all what is recommend the suspension or revocation of the
needed to know to run a blood bank. license to practice the profession when applicable.
• Rules and regulations shall be promulgated sixty • The head of the blood bank and the necessary
(60) days from the approval thereof personnel under the heads direct supervision found
• The rules and regulations shall prescribe from time responsible for dispensing, transfusing and failing to
to time the maximum ceiling for fees for the dispose, within forty-eight (48) hours, blood which
provision of blood, including its collection, processing have been proven contaminated with blood
and storage, professional services and a reasonable transfusion transmissible diseases shall be
allowance for spoilage. imprisoned for ten (10) years.

-Blood has expiration dates depending on the anti- SECTION XIII. Separability Clause
coagulant, storage and blood product type
SECTION XIV. Repealing Clause
SECTION XII. PENALTIES > The Act shall supersede the Republic Act No. 1517
“Blood Bank Act”

-This is the first blood bank law and is now repealed


REPUBLIC ACT NO. 7719 “National Blood Services Act of 1994”
SECTION XV. Effectivity • Confirmed Positive test for HIV/AIDS
• Symptoms of viral hepatitis after age 11
• This act shall take effect after fifteen (15) days following
• Donors implicated in a post-transfusion hepatitis
as publication in the Official Gazette or in two (2)
newspapers of general circulation • AIDS case
• Confirmed positives test for hepatitis C antibody
ADDITIONAL NOTE: (HCab)
Implementing rules and regulation used in the RA 7719: • Confirmed positive test for Human T-cell
lymphotropic virus (HTLV)
• Administrative Order 2008-0008 is the implementing • Malignant solid tumors, except for basal cell
rules and regulations pursuant to R.A. 7719 carcinoma of the skin and carcinoma in-situ of the
cervix
CRITERIA FOR DONOR SELECTION:
• Hematologic malignancies ex. Hemoglobinopathies,
 Age: 17-65 years old, ≤16 needs parents’
Thalassemia
consent
 Weight: 50 kgs or 110 lbs • Chemotherapeutic agents administered for
 Hemoglobin: ≥ 12.5 g/dL malignancy
 Hematocrit : ≥ 38%
• Chronic cardiopulmonary, liver, or renal disease
 Temperature: Oral temp not to exceed 37.5 C
or 99.5 F • Serious abnormal bleeding tendencies
 Pulse: 50-100 beats /minute (lower pulse beat
is accepted for athletes) • Those who have taken the drug etretinate (Tegison)
for the treatment of psoriasis (teratogenic)
 Blood pressure:
AABB (American Association for Blood • History of babesiosis • History of Chagas’ disease
Banking): 180 mmHg –systolic (parasitic infection)
100 mmHg –diastolic
• Anyone who has ever received clotting factor
Philippines: 90-160 mmHg –systolic concentrate
60-100 mmHg –diastolic
• Recipient of pituitary derived growth hormone (risk
Skin lesions: Evidence of skin lesions (e.g. multiple of transmitting Creutzfeld jacob disease)
puncture marks) is cause for indefinite deferral
• Recipient of cornea/dura mater transplant (risk of
transmitting Creutzfeld-jacob disease)

DONOR DEFFERAL • Anyone who have taken insulin from cows (risk of
transmitting Mad cow disease)
PERMANENT/INDEFINITE DEFFERAL
• High risk history of HIV/AIDS TEMPORARY DEFERRAL
• Male who have sex with male since 1977
• Intravenous drug abusers either past or present • Active disease under treatment such as cold, flu,
• Anyone who engaged in sex for money since 1977 tuberculosis, syphilis, infections, curable disease of
• Hemophiliacs the: heart, lung, kidney, liver and gastrointestinal
tract; treatment with antibiotics
REPUBLIC ACT NO. 7719 “National Blood Services Act of 1994”
THREE YEARS DEFFERAL THREE MONTHS DEFERRAL
• Typhoid infection
• Immigrant or refugee coming from an area
considered endemic for malaria, three years after TWO MONTHS DEFERRAL
departure, or those who have had a diagnosis of • Recent blood donation
malaria, three years after becoming asymptomatic
• 56 days for allogenic donation
ONE YEAR DEFFERAL
• Philippines: 12 weeks or three months
• After hepatitis B immune globulin administration
SIX WEEKS DEFERRAL
• After therapeutic rabies vaccination • Following a delivery of a baby
• Rape victims • Philippines: 9 months after childbirth
• Health care workers with percutaneous exposure
to blood or body fluids
ONE MONTH DEFERRAL
• German measles(rubella) vaccination
• Close contact to persons with viral hepatitis in the
last 12 months • After cessation of the drug isotretinoin (Accutane)
for acne treatment
• Tattoo
• After cessation of the drug finasteride (Proscar) for
• Sexual contact with a prostitute or other persons in the treatment of benign prostatic hyperplasia.
high- risk group for HIV/AIDS
TWO WEEKS DEFERRAL
• Incarceration in jail for more than 72 consecutive
hours • After vaccination with oral polio, measles(rubeola),
mumps or yellow fever
• Transfusion of blood components
• After immune reaction to smallpox vaccination
• Transplant such as bone marrow or organ/tissue,
bone or skin graft. 48 HOURS DEFERRAL
• Whole blood donation deferred after hemapheresis
• Had accidental needle stick injury

• History of syphilis or gonorrhea


12-24 HOURS
• After alcohol intake
• Leishmania risk, parasitic infection (travel to Iraq in
the last 3 years)

FOUR MONTHS/120 DAYS DEFERRAL


• 120 days from recovery with clinical diagnosis, or
suspicion of West Nile Virus (WNV) infection
DOH Department Circular No. 2021-0102: Updating of Timing of Blood
Donation When Donors Receive COVID-19 Vaccine in the A to Z Guide to
Medical Assessment of Blood Donors

• Per World Health Organization (WHO), the purpose Type of COVID-19 Timing of Blood
of donor selection is to assess the suitability of an Vaccines Donation
individual to be a blood donor. This is to ensure that Live attenuated 28 days after
blood donation is safe for the donor and the blood vaccine vaccination
products derived from this donation are safe for the
Viral-vector based
recipients.
vaccine (non-
• As COVID-19 continuously affects the world, one of replicating) Ex: 28 days after
the breakthrough events is the availability of COVID- AstraZeneca, vaccination
19 vaccines. As the Philippines implements the “The Sputnik-V, Janssen
National Deployment and Vaccination Plan for Inactivated vaccine
COVID-19 Vaccines”, the National Voluntary Blood Ex: Sinovac 28 days after
Services Program (NVBSP) has taken into account the vaccination
need to update the existing guidelines in the timing Subunit vaccine Accept, anytime if
of blood donation especially for blood donors who asymptomatic
received vaccination against COVID-19. mRNA-based Accept, anytime if
vaccine Ex: asymptomatic
The NVBSP (NATIONAL VOLUNTARY BLOOD Moderna, Pfizer
SERVICES PROGRAM) has recommended to
Unknown vaccine 28 days after
update the list of vaccines with the following deferral type vaccination
period of blood donation for individuals who have
received a vaccination against COVID-19:
-If the patient experienced vaccine-related symptoms
then defer for 28 days after the symptoms even if they
had Pfizer or moderna as their vaccine.
Operations of the DOH
Rules and Regulations Governing
AO 59 s. 200 the Establishment, Operation
CLINICAL LABORATORY ACT
and Maintenance of Clinical
Laboratories in the Philippines
Revised Rules and Regulations
of clinical laboratories and requiring the
AO 27 s. 2007 Governing the Licensure and
registration of the same with the Department of Regulation of Clinical
Health, providing penalty for the violation thereof, Laboratories in the Philippines
and for other purposes.
This law exists to protect and promote an individual’s
Approved on June 18, 1966 health and preventing the operation of substandard,
improperly managed and inadequately supported
President Ferdinand E. Marcos clinical laboratories which may lead to compromised
testing results or which can also lead to poor
management of the patient condition.
the following reasons:

o protect

that are properly managed with adequate


resources, with effective and efficient performance
through the compliance with quality standards.

The following Administrative and Executive Orders


were issued in relation to RA 4688:

Revised Rules and Regulations


Governing the Registration,
AO 201 s 1973 Operations and Maintenance of
Clinical Laboratories in the
Philippines
Amending Section II Subsection
A of Administrative Order No.
AO 290 s 1976 201, Series of 1973 Concerning
Requirements for a Clinical
Laboratory
AO 52 s. 1983 --
Revised Rules and Regulations
Governing the Registration,
AO 49-B s. 1988 Operation and Maintenance of
Clinical Laboratories in the
Philippines
EO 102 s. 1999 Redirecting the Functions and
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
New administrative order released by the introduced as such certain provisions in the
Department of Health, signed by the secretary of current administrative order which is the
health Francisco T. Duque III. Signed June 11, 2021. AO 2007-0027 dated back August 22, 2007
may become out dated.
ABBREVIATIONS
Objective
• DOH-LTO: Department of Health - License to
Operate • To ensure accountability of the laboratory on
generation of accurate, precise and reliable
• DOH-PTC: Department of Health - Permit to laboratory results in a timely manner through
Construct continuous compliance
• HFSRB: Health Facilities and Services and
Regulatory Bureau
Scope
• CHD-RLED: Center for Health Development-
Regulation, Licensing and Enforcement Division • Shall apply to all individuals, agencies,
partnerships or corporations, whether private or
• OLRS: Online Licensing and Regulatory System government-owned, involved in the application for
• OSSOLS: One-Stop Shop Online Licensing System DOH license to operate and those in the operation
of diagnostic clinical laboratories in the Philippines
RATIONALE, OBJECTIVE AND SCOPE
DEFINITION OF TERMS
OF APPLICATION
• Clinical laboratory – a facility that is involved in
Rationale the preanalytical, analytical, and post-analytical
procedures, where tests are done on specimens
• To align the laboratory procedures with the
from the human body to obtain information about
requirements of AO 2020-0047 titled “Rules and
the health status of a patient for the prevention,
Regulations Governing the Licensure of Primary
diagnosis and treatment of diseases. These tests
Care Facilities in the Philippines.”
include, but are not limited the following
• To revise and update the minimum standards and disciplines:
technical requirements for licensing clinical
laboratories in the Philippines aligned with the  Anatomic pathology
main objective of Republic Act No. 11223 or the
Universal Health Care Act which is to guarantee  Clinical chemistry
access to quality and affordable health products,  Clinical microscopy
devices, facilities and services
 Endocrinology


- Through the years several laboratory
Hematology
technological advancement had been
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
 Immunology and Serology


transfer of site
additional services (add-ons) beyond their
 Microbiology service capability

 Molecular and Nuclear diagnostics

 Molecular biology •External Quality Assessment Program (EQAP) —


 Cytogenetics a program where participating CL are given
unknown samples for analysis. The quality of
• Applicant — refers to any natural juridical performance of the CL shall be assessed through
person, government instrumentalities/agencies, the closeness of its results to the pre-determined
partnership, corporation or agency seeking a value or reference value generated by the
license to operate and maintain a clinical participating CL through peer group analysis.
laboratory.
- Samples will be coming from external
• Assessment Tool — the checklist which institutions like /national reference
prescribes the minimum standards and laboratory.
requirements for licensure of clinical laboratory. - Results will be uploaded in the website to
be checked by NRL
• Department of Health - License to Operate
(DOH-LTO) — a formal authorization issued by the • Initial Application — refer to applications by
DOH to an individual, partnership, corporation, newly constructed health facilities, or those with
association or any government agency/unit seeking changes in the circumstances of the facility, such
to perform laboratory tests in compliance with the as, but not limited to, change of ownership,
requirements prescribed in this order. transfer of site, increase in beds or for additional
services beyond their service capability and major
• Department of Health - Permit to Construct
alterations or renovations.
(DOH-PTC) — a permit issued by DOH through
HFSRB or Center for Health Development- • Mobile Clinical Laboratory (MCL) — a laboratory
Regulation, Licensing and Enforcement Division testing unit capable of performing limited CL
(CHD-RLED) to an applicant who will establish and diagnostic procedures. It moves from one testing
operate a hospital or other health facility, upon site to another, and it has a DOH-licensed CL as its
compliance with required documents prior to the main laboratory
actual construction of the said facility. It is also
required for: - Laboratory on wheels
- Add-ons or extensions only of the main
- Prerequisite of license to operate laboratory
 hospitals and other health facilities with
substantial alteration, expansion,
renovation
 increase in the number of beds
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
• National External Quality Assessment Scheme (NEQAS) — an EQAP activity conducted by the National
Reference Laboratories to assess the quality of performance and accuracy of the results of laboratories.

• National Reference Laboratory (NRL) — the highest level of laboratory in the country performing highly
complex procedures, including confirmatory testing. It is the responsible entity for facilitating NEQAS to
ensure compliance to quality standards for regulation and licensing of all laboratories in the Philippines.

Research Institute for NRL for Dengue, Influenza,


Tropical Medicine Tuberculosis and other
Mycobacteria, Malaria and
other parasites, Bacterial
enteric diseases, measles
and other viral exanthems,
Mycology, Enteroviruses,
Antimicrobial resistance
and Emerging Diseases;
External quality assurance program:
NRL for confirmatory
testing of blood If an independent laboratory were to
donors and blood operate these institutions will be the
units. one to give them specific samples to test
depending on what kind of laboratory
they are to see if results value are close
to their results.

San Lazaro Hospital NRL for HIV/AIDS, Hepatitis


(SACCL) and Sexually Transmitted
Diseases
East Avenue Medical NRL for Environmental and
Center Occupational Health;
Toxicology and
Micronutrient Assay.
National Kidney and NRL for Hematology
Transplant Institute including
Immunohematology and
Immunopathology and
Anatomic Pathology
Philippine Heart Center NRL Anatomic Pathology of
Cardiac Diseases
Lung Center of the NRL for Clinical Chemistry
Philippines
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES

• Physician’s Office Laboratory (POL) — refers to a GENERAL GUIDELINES


doctor’s office/clinic wherein CL examinations are
performed for the purpose of monitoring the • All CL shall secure DOH-LTO prior to its
doctor’s patients only, wherein no official results operation and must comply with the minimum
shall be issued. In this Order, POL within the regulatory standards and requirements at all times.
premises of a DOH-regulated facility shall be under
the supervision of the CL. • The DOH-LTO shall be secured from the DOH
regulatory office in accordance with DOH
- Used are point of care testing machine guidelines.
ex. Glucometer, used to monitor the patient
• Only DOH-licensed institution-based CL may have
• Point of Care Testing (POCT) — refers to a SCL which shall be located within the premises of
diagnostic testing done at or near the site of the regulated health facility.
patient care rather than in the CL. It may be in the
emergency room, operating suites, wards, and • A DOH-licensed CL may have MCL services,
ambulances. provided, they adhere to the standard testing
protocols.
• Satellite Clinical Laboratory (SCL) — refers to an
extension of the main CL located within the • The DOH-licensed CL shall not perform any
facility’s compound or premises. It shall have the examinations or testing beyond its authorized
same service capability as the main laboratory. service capability. However, it may be allowed to
offer laboratory services other than the respective
- Ex. A satellite laboratory in the outpatient stipulated minimum services, such as but not
department to test the outpatient, limited to, MCL, SCL, confirmatory testing for
ambulatory patients who are only there for Glucose-6-Phosphate Dehydrogenase Deficiency,
a checkup. and Rapid HIV Diagnostic Algorithm (rHIVda),
- Main laboratory tests the admitted patient provided that the additional services have been
approved and indicated as add-on services in the
• Referral Tests — refers to CL tests that are either
DOH-LTO of the CL.
sent-out or outsourced to other DOH-licensed CL
with the same or higher service capability. • Unit/Section of health facilities performing
diagnostic CL tests such as, but not limited to,
- If tests are not available in your facility then
arterial blood gas and/or Radioimmunoassay for
you can send it to other laboratory to be
thyroid function tests and Prostate Specific Antigen
performed
shall be under the DOH-licensed CL.

• The head of the CL shall be a pathologist


certified by a professional organization recognized
as the Accredited Professional
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
Organizations/Accredited Integrated Professional • At the CHD, the Director IV, shall approve the
Organizations of the Professional Regulation issuance of the DOH-LTO of the CL.
Commission. The head of laboratory shall ensure
• In the advent of new technologies or diagnostic
the optimal overall operations and maintenance
platforms that shall affect the current licensing
of the CL and if applicable, of its SCL and MCL.
standards for CL, Department Circulars shall be
• There shall be an adequate number of issued, as needed, as supplements to this Order.
competent personnel assigned in the different
• The CL shall be compliant with the prescribed
services provided by the DOH-licensed CL, which
standards and requirements, Assessment Tool for
includes the MCL, SCL, remote collection activities,
Licensing Clinical Laboratories and other relevant
if applicable.
laws and issuances. These standards shall also
-medical laboratory technologists, medical apply to MCL and SCL.
technician, laboratory aid, phlebotomist,
• The DOH-LTO may be revoked, suspended or
receptionists
modified in full or in part for any false statement
• CLs that are operated and maintained exclusively by the applicant, or as shown by the record of
for research and teaching purposes shall be inspection or for a violation of, or failure to comply
required to register with the DOH-HFSRB. with any of the terms and conditions and
provisions of these rules and regulations.
- Laboratories intended for teaching and
research purposes only does not require SPECIFIC GUIDELINES
License to operate but rather a certificate of
registration under DOH-HFSRB 1. Classification by Ownership
• The DOH designated NRL shall be covered by a. Government: operated and maintained, partially
the license of the CL of the hospital where they or wholly, by the national government, a local
are affiliated with. Independent NRLs, or those government unit (provincial, city or municipal), any
designated by DOH but are not affiliated with any other political unit or any department, division,
DOH-regulated health facility, shall secure a DOH- board or agency.
LTO from HFSRB.
b. Private: privately owned, established, and
• All CLs shall make their prices for laboratory operated with funds through donation, principal,
services accessible to the public as mandated by investment or other means, by any individual,
the UHC law and related DOH issuances. corporation, association or organization.

- Posted prices on tests 2. Classification by Institutional Character


• At the Central Office, the Director IV, or in a. Institution-based: a laboratory located within
his/her absence or unavailability or when the premises and operates as part of a DOH
delegated, the Director III of HFSRB, shall approve licensed health facility.
the issuance of the DOH-LTO of the CL.
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
- hospital-based

b. Non-institution based: a laboratory that b. Anatomic Pathology: provides processing and


operates independently and is not attached to any examination of surgical specimens as to physical
DOH licensed health facility. appearance and microscopic structures of tissues
such as, but not limited to, surgical pathology,
- free standing laboratory
cytopathology, immunohistochemistry techniques,
3. Classification by Function autopsies and forensic pathologies.

c. Molecular Pathology: deals with the analysis of


a. Clinical Pathology: deals with the chemical and
certain genes, proteins and other molecules in
cellular analyses of blood and other body fluids
(includes, but not limited to, clinical chemistry, samples from organs, tissues of bodily fluids in
clinical microscopy, toxicology, therapeutic drug order to diagnose disease/ and or to guide the
prevention and treatment of disease based on the
monitoring, immunology and serology, hematology
and coagulation), identification and examination of principles, techniques and tools of molecular
biology as they are applied to diagnostic medicine
microbes and parasites
(bacteriology/parasitology/mycology/virology) in the laboratory.
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
4. Classification by Service Capability
a. Clinical Laboratory for Clinical and Anatomic Pathology

Category
i. Primary ii. Secondary iii. Tertiary v. Limited
Section Provides the Provides the Provides the Provides one or 2
following minimum minimum service minimum service specialized tests that are
service capabilities: capabilities of a capabilities of a not classified under
primary category secondary category Anatomic or Molecular
plus the following: plus the following: Pathology, as exemplified
Clinical Microscopy • Urinalysis below:
• Fecalysis • Hormones
• Fecal Occult Blood • Trace Metals
Test • Tumor Markers
• Pregnancy Test • Allergy Panel
(Rapid Test Kits- • This classification shall
Lateral Flow) also apply to facilities
• Wet smears for offering DOH-program
Trichomonas related tests (e.g., Kato-
Katz for Schistosomiasis,
Malarial Smear, Filarial
Smear, Slitskin Smear,
Clinical Chemistry • Fasting and Random • Serum • Other Clinical Rapid Plasma Reagin for
Blood Sugar • Oral Electrolytes (Na, K, Chemistry Syphilis
Glucose Tolerance Cl) Examinations
Test • ALT • Hospital-based:
• Lipid Profile( Total • AST Arterial Blood Gas
Cholesterol, HDL, LDL,
Triglycerides)
• Creatinine
• Blood Urea
Nitrogen
• Blood Uric Acid
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
Category
i. Primary ii. Secondary iii. Tertiary iv. Limited
Provides the Provides the Provides the
Section following minimum minimum service minimum service
service capabilities: capabilities of a capabilities of a
primary category secondary category
plus the following: plus the following:
Hematology • Complete Blood For Hospital-based:
Count • Coagulation
(Hemoglobin, RBC studies (PT, aPTT)
Count, WBC Count
with Differential
Count, Quantitative
Platelet Count
• Forward and
reverse ABO
grouping and Rh
(D) typing (tube
method)
Serology/ • Dengue • Any machine-
Immunology • Syphilis based serological
• Hepatitis B and immunological
(screening) testing such as, but
• HIV (screening) not limited to
using rapid test tumor markers,
kits thyroid function
tests and hepatitis
profile

Category
i. Primary ii. Secondary iii. Tertiary iv. Limited
Provides the Provides the Provides the
Section following minimum minimum service minimum service
service capabilities: capabilities of a capabilities of a
primary category secondary category
plus the following: plus the following:
• TB (DSSM) or • Gram Stain • Culture and
Nucleic Acid • KOH Sensitivity (aerobic
Microbiology Amplification Test and anaerobic)
for government
facilities
Anatomic - Not • Pap smear For Hospital-based:
• Cytology and
Pathology
offered Histopathology
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
b. Clinical Laboratory for Anatomic Pathology only • The DOH-LTO shall be placed in an area that can
— provides services for any of the following, but not be readily seen by the public, at all times.
limited to cytology and histopathology.
• For institution-based CL, the One-Stop Shop (OSS)
c. Clinical Laboratory for Molecular Pathology only Licensing System should be followed.
— provides services for genetics,
-If hospital license shall renew then laboratory
immuno/hematopathology and infectious disease.
license must be renewed simultaneously
COVID-19 testing laboratories shall be covered by
another Order. Validity
PROCEDURAL GUIDELINES • The DOH-LTO is valid for one (1) year.

• COR for CL that is operated and maintained


DOH Permit to Construct (DOH-PTC)
exclusively for research and teaching purposes shall
• completely filled out application form for
be required to register with the DOH-HFSRB every
(downloadable at www.hfsrb.doh.gov.ph), whether
three (3) years.
manual or online, shall be submitted to the DOH
regulatory offices Fees
• for construction of new CL and for renovation or • All fees shall follow the prescribed fees by the
expansion of existing CL, including change in DOH. All fees/checks shall be paid to the order of
ownership and transfer of location DOH Central Office/ CHD Cashier, whichever is
applicable in person, through postal money order or
Certificate of Registration (COR) online payments approved by the DOH.
• required for research and teaching laboratories
Monitoring
License to Operate (LTO) • Authorized representatives from the HFSRB/CHD-
• Applicant should submit an accomplished RLED in accordance with the current DOH
application form to HFSRB/CHD-RLED in accordance guidelines, may conduct unannounced on-site visits
with the current DOH guidelines, whether manual or of licensed CL and registered research and teaching
through the Online Licensing and Regulatory System laboratories to monitor and document the
(OLRS) continuous compliance of the CL to the set
• The DOH-LTO is non-transferable and a new standards.
application for DOH-LTO shall be required in case of • CL that are operated and maintained exclusively
change of ownership or transfer of location. for research and teaching purposes shall not issue
• Different branch(es) of a CL, even if owned by the official results for diagnostic purposes.
same entity shall secure separate DOH-LTO.
- each laboratory must have their own LTO
ex.laboratory branches
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
Health Facilities and Services and • Maintain the National External Quality Assessment
Regulatory Bureau (HFSRB) Scheme (NEQAS).

• Set standards for the regulation of CL and strictly • Perform technical evaluation of reagents and
enforce the provisions of this Order. diagnostic kits.

• Disseminate regulatory policies, standards and DOH-Licensed Clinical Laboratories


forms for information and guidelines of the DOH-
• Continuously comply with the rules and
CHDs.
regulations, licensing standards and requirements
• Provide consultation and technical assistance to for CL, as provided in this Order and related
stakeholders, including regulatory officers from the issuances.
DOH-CHDs in line with the regulation of CL.
• Participate in EQAP that may be administered by a
• Respond promptly to complaints relative to the designated NRL or other local and international
operation of CL under its jurisdiction. EQAP approved by the DOH, surveys and other
activities that will be required from them by the
Center for Health Development — DOH.
Regulatory, Licensing, and Enforcement
• In times of Pandemic of Public Health Event, be
Division (CHD-RLED) mandated to submit timely reports and data.
• Strictly enforce the provisions of this Order.
VIOLATIONS, SANCTIONS AND APPEAL
• Submit quarterly report on
• A CL shall be sanctioned and penalized by the
Suspension/Revocation/ Cease and Desist Order
HFSRB/CHD Director upon violation of any of these
issued on CL not later than the 15th day of the
guidelines and its related issuances and laws, or
following month after the covered quarter.
upon committal (commission/omission) of
• Provide consultation and technical assistance to prohibited acts by the persons owning or operating
stakeholders in line with the regulation of CL. the CL, and/or the persons under their authority.

• Respond promptly to complaints relative to the • For non-institution-based CL that are not under
operation of CL under its jurisdiction. the OSSOLS, the following are the penalties and
sanctions that shall be imposed for the commission
National Reference Laboratories (NRL) of any of the violations in this Order and other
relevant issuances:
• Provide laboratory reference/referral services for
confirmatory testing. • 1st offense: Stern warning

• Train laboratory personnel and recognize other • 2nd offense: Thirty thousand pesos (Php
training institutions. 30,000.00)

• 3rd offense: Fifty thousand pesos (Php 50,000.00)


ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
• 4th offense: Revocation of DOH-LTO • The laboratory shall conform to the required
space for the conduct of its activities. Personnel,
• Any person who operates a CL without securing
fixtures, equipment, sink, etc. shall also be
the necessary DOH-PTC and corresponding DOH-
considered.
LTO shall be issued a Cease-and-Desist Order (CDO)
and shall pay the administrative penalty of Fifty • There shall be well-ventilated, lighted, clean, safe
thousand pesos (Php50,000.00). and functional areas based on the services
provided.
• In case of complaints, the CL, upon receipt of such
by HFSRB/CHD-RLED shall be given due process • There shall be a program of proper maintenance
wherein an investigation shall be conducted and the and monitoring of physical plant and facilities.
appropriate sanctions for its violation/s. A 60-day
• There shall be policy guidelines on laboratory
preventive suspension may be given to the CL
biosafety and biosecurity which includes risk
during the investigation depending on the
assessment that will serve as the basis of biosafety
seriousness of the violation.
level required for the specific CL.
• May appeal to the Head of the Health Regulation
• There shall be an area for confirmatory testing for
Team (HRT). The decision of the Head of the HRT, if
Rapid HIV Diagnostic Algorithm and Glucose-6-
still contested may be brought on a final appeal to
Phosphate Dehydrogenase (G6PD) Deficiency which
the Secretary of Health, whose decision shall be
may be a section, unit, or division integrated in a
final and executory.
DOH licensed CL, if applicable.
• CL with revoked licenses can only re-apply after
PERSONNEL HEAD OF THE LABORATORY (HOL)
one year from the date of LTO revocation.
• Shall be a competent and experienced
• Any person authorized or licensed to conduct
professional, with a specialized skill set related to
clinical laboratory tests, who issues false or
and proportionate to the laboratory category, to
fraudulent laboratory test results knowingly,
ensure that the laboratory runs efficiently
willfully or through gross negligence shall not be
allowed to own, manage, operate, or be an analyst - pathologist
of any DOH-licensed CL.
• Essentially responsible for the operation of the
LICENSING STANDARDS FOR CLINICAL entire laboratory, its personnel, functions, and data,
LABORATORY all of which shall meet the quality assurance criteria
and regulatory requirements
PHYSICAL PLANT
• Shall oversee the operation of the CL and have
• The CL shall conform to all applicable local and administrative and technical supervision of the
national regulations for the construction, activities including the mobile clinical laboratories
renovation, maintenance and repair of CL. (MCL), remote collection activities, and point of care
testing (POCT), if applicable.
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
• Shall supervise the staff in accordance with the technician, laboratory aide, encoders, and
standards set by the Philippine Society of receptionists when applicable.
Pathologists
POCT COORDINATOR — if applicable
• Shall visit once a month and at least twice a week
of supervisory calls and/or videoconferencing or at • A senior staff from the CL shall be
least once a week physical visit. For hospital-based designated as a POCT coordinator who shall
DOH licensed CL, it shall be once a week physical have the following functions, but not limited
visit. The visits shall have to be well documented.
to:
• For Geographically Isolated and Disadvantaged
• Recommends procedures that will ensure the
Areas (GIDAs) with no clinical pathologists, as
quality of results of POCT in consultation with the
certified by the Philippine Society of Pathologists,
pathologist.
board certified Anatomic Pathologists or Physicians
with complete training in Clinical Laboratory • Ensures that POCT machines/device and kits are
Medicine, Quality Assurance and Laboratory properly maintained.
Management, may head one primary DOH licensed
• Supervises the operators of POCT device/machine.
CL.
• Ensures that the operators have appropriate
REGISTERED MEDICAL TECHNOLOGIST
trainings and checks the competency of the
(RMT) operators regularly.
• There shall be an adequate number of full-time • Ensures that quality control (QC) is implemented
RMTs conduct the laboratory procedures, including and reviews POCT QC results periodically, depending
those assigned in MCL. The number of staff shall on the number of tests.
depend on the workload and the services being
provided. POCT OPERATOR — if applicable
• There shall be staff development and continuing • The designated operator of the POCT
education program at all levels of organization to device/machine and testing kits shall have the
upgrade the knowledge, attitude and skills of staff. following functions, but not limited to:

• There shall be a designated Biosafety and • Ensures accurate results of POCT.


Biosecurity Officer in-charge primarily of the risk
• Ensure that POCT machines/device and kits are
assessment of the DOH licensed CL.
properly maintained and stored.
SUPPORT STAFF
• Run tests on quality control at least once each day
• There shall be an adequate number of support or as recommended by the manufacturer.
staff such as, but not limited to laboratory
• Initially, implements quality assurance program or
contact the manufacturer’s application specialist for
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
assistance, when a POCT machine/device is not - This inventory is done to track your
properly functioning, or the control sample is in consumables
outof-control range.
• machines/devices, reagents and test kits that are
• Reports to the supervising CL any untoward used in the CL and MCL as well as POCT shall be
incidents or problems approved by the Philippine Food and Drug
Administration and validated by the proper
MCL PERSONNEL government institutions (e.g. National Reference
Laboratory).
MCL shall has its own set of personnel, which
includes the following but not limited to: • The MCL shall have its own set of functional, and
• Registered Medical Technologist — number will operational equipment, as well as its own set of
depend on the anticipated workload. supplies.

-Mobile clinical laboratories should have their own


• Support staff such as, but not limited to, driver
and laboratory technician. required utilities and not borrowing from the main
one.
EQUIPMENT/INSTRUMENTS/REAGENTS/GL
SERVICE DELIVERY
ASSWARES/SUPPLIES There shall be:
• All CL shall ensure that the service being delivered to
• available and operational patients must comply with the standards and other
equipment/machines/devices to provide the related relevant issuances.
laboratory examination that the laboratory is
licensed for. • Mobile Clinical Laboratory: collection site/area for MCL
shall be located within the same region, at a maximum
• a calibration, preventive maintenance and repair of one hundred (100) kilometer radius, from the address
program for every equipment/ of the DOH licensed CL.
machines/instruments/devices in the DOH licensed
• Aside from specimen collection for different tests
CL. within the service capability of the main CL, the MCL
shall be allowed to perform the following on-site tests
• a contingency plan in case of
which shall be declared in the LTO of the main CL:
equipment/machines/devices breakdown and
malfunction.  Urinalysis
 Fecalysis
• adequate available reagents, glassware and
 Pregnancy Test (lateral flow)
supplies for the laboratory examinations.
 Basic Serologic Test using Rapid Test Kits —
• an inventory control of the reagents, glassware Dengue, Screening of Hepatitis B, RPR/Syphilis
Test, and HIV
and supplies, reagents, glassware and supplies shall
be properly stored under the required conditions. • Specimen collected for other test, not mentioned
above should be properly handled and transported.
Serum blood samples for chemistry testing must be
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
separated within four (4) hours from the time of • All results shall be released in accordance with
collection. DOH guidelines.

INFORMATION MANAGEMENT • All laboratory reports on various examinations of


Administrative Policies and Procedures specimens shall bear the name, PRC registration
number, and original signature of the registered
• The CL shall have written policies and procedures
medical technologist(s) who performed the
for the provision of laboratory services, the
laboratory examinations, and the pathologist who
operation and maintenance of the CL, which
shall be accountable for the reliability of the results.
includes satellite laboratories, MCL and POCT, and
shall include the accountabilities of every personnel • There shall be a policy guideline on the use of
working in the laboratory. digital signature. The use of digital signature for
laboratory results shall be permitted only if properly
• There shall be documented technical procedures
authenticated by the Department of Information
for services provided in each section of the
and Communication-Philippine National Public
laboratory, including MCL and POCT, which will
Infrastructure. The use of digital signature shall also
ensure the quality of laboratory results.
be in accordance with the provisions of the E-
• There shall be a risk assessment for every section Commerce Law.
in the CL.
• There shall be procedures for the reporting of
- Your laboratory should have a Standard workload, quality control, inventory control, work
Operating Procedure (SOP) manual wherein schedule and assignments.
all standards are procedures are contained
- Log books are a must
Communication and Records Management • There shall be procedures for the reporting and
analysis of incidents, adverse events, and in
• The CL shall maintain and ensure the
confidentiality of all records. handling complaints.

- All records are confidential • The retention of laboratory documents, records,


slides and specimens shall be in accordance to the
• There shall be procedures for the receipt and standards promulgated by the DOH or by competent
performance of routine and STAT requests for authorities for such purposes.
laboratory examinations.
• The operating hours of the CL shall be known to its
• There shall be procedures for the reporting of clients.
results of routine and STAT laboratory examinations,
• The CL which supervises the POCT shall have a
including critical values that would impact on
master list of the following, but not limited to a.
patient care.
name and designation of operators, and b. POCT
- Tests results must be released in 2-3 hours machines, instruments and kits.
while STAT results must be in an hour
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
QUALITY IMPROVEMENT - Sent out means that you will be sending the
specimen to other laboratory to be
• There shall be an Internal Quality Assurance examined if the test is beyond the service
Program which shall include: capability of the laboratory.

- An Internal Quality Control Program for • If referral of laboratory test is part of the
technical procedures. contingency plan, in cases of equipment
- An Internal Quality Assurance Program for breakdown, of the referring CL, this shall be for a
inputs, processes and outputs. certain limited period of time only, which shall not
- A Continuous Quality Improvement Program last for more than 3 months. This shall be properly
covering all aspects of laboratory documented
performance.
ENVIRONMENTAL MANAGEMENT
• The CL shall participate in External Quality
Assessment Program (EQAP) that may be • There shall be a program of proper maintenance
administered by a designated NRL or other local and and monitoring of physical facilities.
international EQAP approved by the DOH.
• There shall be procedures for proper disposal of
REFERRAL OF LABORATORY infectious wastes and toxic and hazardous
substances in accordance with RA 6969, also known
EXAMINATIONS
as “Toxic Substances and Hazardous and Nuclear
• The referral laboratory must be a DOH-licensed CL. Wastes Control Act of 1990” and other related
They shall have a Memorandum of Agreement policy guidelines and/or issuances.
(MOA) with the referring CL and shall be responsible
• There shall be a “No smoking policy” and that the
for the collection, transport and processing of
same shall be strictly enforced.
specimens, and releasing of results.
• There shall be a contingency plan in case of
• A separate MOA is required when referred tests,
accidents and emergencies.
which are not within the service capability of the CL,
unless the referral is part of the contingency plan. • There shall be a policy for biosafety and
biosecurity. • There shall be policy guidelines on
• A MOA prescribing the accountabilities of each
infection prevention and control
party, shall be secured when laboratory
examinations are referred to and provided by PROHIBITED ACTS IN THE OPERATIONS OF
another DOH-licensed CL.
CLINICAL LABORATORIES
• Referral of examinations to other DOH-licensed CL
The Clinical Laboratory (CL) may be sanctioned or
are only permitted in the following circumstances:
penalized upon commission of the following
• If the laboratory test to be sent out is not part of prohibited acts and violations:
the service capability expected for the particular
category of the referring laboratory.
ADMINISTRATIVE ORDER NO.2021-0037
NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
• Refusal to allow HFSRB/CHD-RLED authorized • Violation of provisions in the Republic Act No.
personnel to conduct inspection or monitoring 10173 or the Data Privacy Act of 2021.
visits of the clinical laboratory at any appropriate
The DOH-LTO will be revoked immediately after
time;
commission of the following prohibited acts and
• Refusal or nonparticipation of any CL in an violations:
External Quality Assessment Program (EQAP)
• Permitting unauthorized or unregistered
provided by a designated NRL or other local and
personnel to perform technical procedures and
international EQAP approved by the DOH;
access to laboratory records/data;
• Absence of action to improve the unsatisfactory
• Lending or using the name of the DOH-licensed CL
or failed EQAP administered by a designated NRL or
or the head of the laboratory or medical
other local and international EQAP approved by the
technologist to an unlicensed CL;
DOH;
• Unauthorized use of the name and signature of
• Demonstrating incompetence or making
the pathologist and RMT to secure LTO;
consistent errors in the performance of CL
examinations and procedures; • Issuance of fraudulent laboratory results, or tests
not actually done or inaccurate results;
• Deviation from the standard test procedures
including use of expired reagents; • Change in the ownership, location, and head of
the laboratory or laboratory personnel without
• Issuance of a laboratory report without the
informing the HFSRB/CHD-RLED; and,
approval of the head of the laboratory;
• Any material false statement in the application of
• Transferring of laboratory results done by
LTO.
another laboratory to the result form of the
referring laboratory;

- In case of sent out tests, whatever result


comes out will be absolute.

• Performing laboratory procedures beyond their


authorized service capability; and,

• Giving and receiving any commission, bonus,


kickback or rebate or engaging in any split-fee
arrangement in any form whatsoever with any
facility, physician, organization, agency or person,
either directly or indirectly, for patients referred to a
CL licensed by the DOH.
MEDICAL TECHNOLOGY LAWS AND BIOETHICS
OUR LADY OF FATIMA UNIVERSITY
2ND YEAR, 2ND SEMESTER Finals

REPUBLIC ACT NO. 9165 • Participation of the family, students, teachers


and school authorities in the enforcement of
(Lesson 9- Week 14) this act
TOPIC OUTLINE: • Promotion of a national drug-free workplace
RA 9165: Comprehensive Dangerous Drug program with the participation of private and
Act
labor sectors and the DOLE
Articles
Declaration of Policy • Participation of the private and labor sectors
Definition of Terms in the enforcement of this act
Unlawful Acts & Penalties • Participation of local government units
Dangerous Drugs Board • Program for treatment and rehabilitation of
Sec. 21 drug dependents
Dangerous Drug Test and Record
Requirements
• Dangerous Drugs Board and Philippine Drug
Toxicology of Drugs of Abuse Enforcement Agency
Laboratory Test • Appropriations, management of funds and
Designer Drugs and Drugs of Abuse annual report
• Jurisdiction over dangerous drugs cases
• Implementing rules and regulations
REPUBLIC ACT NO. 9165:
COMPREHENSIVE DANGEROUS DRUG • Final provision
ACT OF 2002 ULTIMATE OBJECTIVE OF THE LAW
Consolidation: Declaration of Policy
❖ Senate Bill No. 1858 of May 30, 2002 ❖ To safeguard the integrity of its territory and
❖ House Bill No. 413 of May 29, 2002 the well-being the youth from the harmful
❖ Repealing Law for RA 6425 known a effects of dangerous drugs on their physical
Dangerous Drug Act of 1972 and mental well-being
❖ RA 10640 of July 15, 2014 (SB 2285 and HB ❖ To defend the same against acts or omissions
2273 of June 9, 2014) amending section 21 of detrimental to their development and
RA 9165 preservation
❖ Date of Approval: June 7, 2002 ❖ To enhance further the efficacy of the law
❖ President: Gloria Macapagal Arroyo against dangerous drugs, it being one of
❖ Number of Sections: 102 sections today’s more serious social ills
❖ Number of Articles: 13 articles ❖ To pursue an intensive and unrelenting
ARTICLES campaign against the trafficking and use of
dangerous drugs and other similar substances
• Definition of terms ❖ To achieve a balance in the national drug
• Unlawful acts and penalties control program so that people with
• Dangerous drugs test and record legitimate medical needs are not prevented
requirements from being treated with adequate amounts of
appropriate medications.

1
❖ To provide effective mechanisms or raising of any plant which is the source of a
measures to re-integrate into society dangerous drug.
individuals who have fallen victims to drug ➢ Dangerous Drugs – drug/s with detrimental
abuse or dangerous drug dependence through effect to humans
sustainable programs of treatment and ➢ Deliver – passing a dangerous drug to another
rehabilitation ➢ Den, Dive or Resort – place where any
dangerous drug and/or controlled precursor and
DEFINITION OF TERMS essential chemical is administered, delivered,
➢ Administer – act of introducing any dangerous stored for illegal purposes, distributed, sold or
drug into the body of any person, with or without used in any form.
his/her knowledge, by injection, inhalation, * Warehouse where drugs are stored
ingestion or other means, or of committing any ➢ Dispense – giving away, selling or distributing
act of indispensable assistance to a person in medicine or any dangerous drug with or without
administering a dangerous drug to the use of prescription.
himself/herself unless administered by a duly ➢ Drug Dependence – it is a cluster of
licensed practitioner for purposes of medication. physiological, behavioral and cognitive
➢ Board – Dangerous Drugs Board phenomena of variable intensity, a strong desire
➢ Centers – treatment and rehabilitation centers for or a sense of compulsion to take the substance
drug dependents and the difficulties in controlling substance-
➢ Chemical Diversion – sale, distribution, supply taking behavior
or transport of precursors and essential ➢ Drug Syndicate – organized group of two (2) or
chemicals, in diluted, mixtures or in concentrated more persons forming or joining together with
form, to any person or entity engaged in the the intention of committing any offense
manufacture of any dangerous drug, and shall ➢ Employee of Den, Dive or Resort – caretaker,
include packaging, repackaging, labeling, helper, watchman, lookout, and other persons
relabeling or concealment of such transaction working in the den, dive or resort
through fraud, destruction of documents, ➢ Financier – person who pays for, raises or
fraudulent use of permits, misdeclaration, use of supplies money for
front companies or mail fraud. ➢ Illegal Trafficking – illegal cultivation, culture,
➢ Clandestine Laboratory – facility used for the delivery, administration, dispensation,
illegal manufacture of any dangerous drug and/or manufacture, sale, trading, transportation,
controlled precursor and essential chemical distribution, importation, exportation and
➢ Confirmatory Test – an analytical test which possession of any dangerous drug and/or
will validate and confirm the result of the controlled precursor and essential chemical.
screening test. ➢ Instrument – anything that is used in or intended
➢ Controlled Delivery – consignment of any to be used in any manner in the commission of
dangerous drug and/or controlled precursor and illegal drug trafficking or related offenses.
essential chemical to pass into, through or out of ➢ Laboratory Equipment – paraphernalia,
the country apparatus, materials or appliances when used,
➢ Controlled Precursors and Essential intended for use or designed for use in the
Chemicals – raw materials manufacture of any dangerous drug and/or
➢ Cultivate or Culture – planting, growing, controlled precursor and essential chemical
raising, or permitting the planting, growing or ➢ Manufacture – production, preparation,
compounding or processing of any dangerous

2
drug and/or controlled precursor and essential whatsoever, or distributes, dispatches in transit or
chemical, transports dangerous drugs or who acts as a
− chemical synthesis broker in any of such transactions
− packaging or repackaging of such ➢ School – educational institution, private or public
substances ➢ Screening Test – rapid test performed to
− labeling or relabeling of its container establish potential/ presumptive positive result.
➢ Cannabis – Marijuana, Indian Hemp, hashish, *Screening test = drug test kit + 5 drops of urine
bhang, guaza, churrus and ganja
− Cannabis sativa L. * negative = 2 lines ; positive = 1 line
− Cannabis americana ➢ Sell – giving away any dangerous drug and/or
➢ Methylenedioxymethamphetamine (MDMA): controlled precursor and essential chemical
Ecstasy whether for money or any other consideration.
➢ Methamphetamine Hydrochloride: Shabu, Ice, ➢ Trading – transactions involving the illegal
Meth trafficking of dangerous drugs and/or controlled
➢ Opium: coagulated juice of the opium poppy precursors and essential chemicals using
(Papaver somniferum L.) electronic devices such as, but not limited to, text
➢ Opium Poppy – part of the plant of the species messages, e-mail, mobile or landlines, two-way
− Papaver somniferum L. radios, internet, instant messengers and chat
− Papaver setigerum DC rooms or acting as a broker
− Papaver orientale ➢ Use – injecting, intravenously or
− Papaver bracteatum intramuscularly, or consuming, either by
− Papaver rhoeas chewing, smoking, sniffing, eating, swallowing,
➢ PDEA: Philippine Drug Enforcement Agency drinking or otherwise introducing into the
➢ Person – entity capable of acquiring rights or physiological system of the body, any of the
entering into obligations dangerous drugs.
➢ Planting of Evidence – inserting, placing,
adding or attaching directly or indirectly, through
any overt or covert act, whatever quantity of any
dangerous drug and/or controlled precursor and
essential chemical in the person, house, effects or
in the immediate vicinity of an innocent
individual for the purpose of implicating,
incriminating or imputing the commission of any
violation
➢ Practitioner – licensed physician, dentist,
chemist, medical technologist, nurse, midwife,
veterinarian or pharmacist in the Philippines.
➢ Protector/Coddler – consents to the unlawful
acts provided for in this Act and uses his/her
influence, power or position in shielding,
harboring, screening or facilitating the escape of
any person he/she knows
➢ Pusher – sells, trades, administers, dispenses,
delivers or gives away to another, on any terms

3
UNLAWFUL ACTS

UNLAWFUL ACTS IMPRISONMENT FINES


• Importation of dangerous drugs
• Importation of dangerous drugs and/or
controlled precursors and essential chemicals
using diplomatic passport or facilities
(diplomatic passport shall be confiscated and
canceled)
• Financier
• Sale, trading, administration, dispensation,
delivery, distribution and transportation of
dangerous drugs
• Sale, trading, administration, dispensation,
delivery, distribution or transportation of any
dangerous drug and/or controlled precursor
and essential chemical transpires within one
hundred (100) meters from the school
• Drug pushers who use minors or mentally
incapacitated individuals as runners, couriers
and messengers
Five hundred
• Proximate cause of death of a victim (minor
Life imprisonment thousand pesos
or a mentally incapacitated individual)
to death (Reclusion Perpetua) (P500,000.00) to
• Maintenance of a den, dive or resort where
Ten million pesos
any dangerous drug is used or sold
(P10,000,000.00)
• Dangerous drug is administered, delivered or
sold to a minor who is allowed to use the
same in such a place.
• Manufacture of dangerous drugs
• Possession of dangerous drugs
(1) 10 grams or more of opium
(2) 10 grams or more of morphine
(3) 10 grams or more of heroin
(4) 10 grams or more of cocaine or cocaine
hydrochloride
(5) 50 grams or more of methamphetamine
hydrochloride or “shabu”
(6) 10 grams or more of marijuana resin or
marijuana resin oil
(7) 500 grams or more of marijuana
(8) 10 grams or more (MDMA) or “ecstasy”,
paramethoxyamphetamine (PMA),
trimethoxyamphetamine (TMA), lysergic
acid diethylamine (LSD) and gamma
hydroxybutyrate (GHB)

4
• Possession of dangerous drugs during parties,
social gatherings or meetings
• Cultivation or culture of plants classified as
dangerous drugs
• Unlawful prescription of dangerous drugs Five hundred
• Criminal liability of a public officer or Life imprisonment thousand pesos
employee for misappropriation, to death (P500,000.00) to
misapplication or failure to account for the (Reclusion Perpetua) Ten million pesos
confiscated, seized and/or surrendered (P10,000,000.00)
dangerous drugs, plant sources of dangerous
drugs, controlled precursors and essential
chemicals, instruments/paraphernalia and/or
laboratory equipment (absolute perpetual
disqualification from any public office)
• Criminal liability of government officials and
employees
• Criminal liability for planting of evidence

All associated to dangerous drugs


• Dangerous drug be the proximate cause of the One million
death of a person using the same in such den, Life imprisonment (P1,000,000.00) to
dive or resort to death (Reclusion Perpetua) Fifteen million pesos
(P15,000,000.00)
• Importation controlled precursors and
essential chemicals
• Protector/Coddler
• Sale, trading, administration, dispensation,
delivery, distribution and transportation,
controlled precursors and essential chemicals
• Maintenance of a den, dive or resort where
any controlled precursor and essential
One hundred
chemical
Twelve (12) years thousand pesos
• Employees and visitors of a den, dive or resort
and one (1) day to (P100,000.00) to
• Manufacture of controlled precursor and twenty (20) years Five hundred
essential chemical (Reclusion Temporal) thousand pesos
• Illegal chemical diversion of controlled (P500,000.00)
precursors and essential chemicals
• Manufacture or delivery of equipment,
instrument, apparatus, and other
paraphernalia for dangerous drugs and/or
controlled precursors and essential chemicals
• Unnecessary prescription of dangerous drugs
(additional penalty of the revocation of
his/her license to practice)
• Possession of paraphernalia Six (6) months and Ten thousand
• Possession of equipment, instrument, one (1) day to four pesos (P10,000.00)
apparatus and other paraphernalia for (4) years to Fifty thousand

5
dangerous drugs during parties, social (Prision Coreccional) pesos (P50,000.00)
gatherings or meetings
• Methamphetamine hydrochloride or “shabu” Four hundred
is ten (10) grams or more but less than fifty thousand pesos
(50) grams Life imprisonment (P400,000.00) to
(Reclusion Perpetua) Five hundred
thousand pesos
(P500,000.00)
• Quantities of dangerous drugs are five (5)
grams or more but less than ten (10) grams of
opium, morphine, heroin, cocaine or cocaine Four hundred
hydrochloride, marijuana resin or marijuana thousand pesos
Twenty (20) years
resin oil, methamphetamine hydrochloride or (P400,000.00) to
and one (1) day to
“shabu”, or other dangerous drugs such as, but Five hundred
life imprisonment
not limited to, MDMA or “ecstasy”, PMA, thousand pesos
TMA, LSD, GHB (P500,000.00)
• Three hundred (300) grams or more but less
than five hundred (500) grams of marijuana
• Quantities of dangerous drugs are less than
five (5) grams of opium, morphine, heroin,
cocaine or cocaine hydrochloride, marijuana Three hundred
resin or marijuana resin oil, Twelve (12) years thousand pesos
methamphetamine hydrochloride or “shabu”, and one (1) day to (P300,000.00) to
or other dangerous drugs such as, but not twenty (20) years Four hundred
limited to, MDMA or “ecstasy”, PMA, TMA, (Reclusion Temporal) thousand pesos
LSD, GHB (P400,000.00),
• Less than three hundred (300) grams of
marijuana
• Possession of equipment, instrument,
apparatus and other paraphernalia for Ten thousand
Six (6) months and
dangerous drugs pesos (P10,000.00)
one (1) day to four
• Liability to a person violating any regulation to Fifty thousand
(4) years
issued by the board pesos
(Prision Coreccional)
(P50,000.00)

• Maintenance and keeping of original records


of transactions on dangerous drugs and/or Ten thousand
One (1) year and
controlled precursors and essential chemicals pesos (P10,000.00)
one (1) day to six
to Fifty thousand
(6) years
pesos (P50,000.00)

• Additional penalty if offender is an alien Deported


immediately
without further
proceedings,
unless the penalty
is death
• Use of dangerous drugs Minimum of six (6) Fifty thousand

6
• Alleged person dependent on drugs → Board months pesos (P50,000.00)
petition for rehabilitation (RTC) → Court rehabilitation in a to Two hundred
hearing → Court order (examine the person government center thousand pesos
by an accredited physician) for the first offense (P200,000.00)
• Negative: discharge the person
• Positive: treatment and rehabilitation
If apprehended
using any
dangerous drug for
the second time,
he/she shall suffer
imprisonment
ranging from six (6)
years and one (1)
day to twelve (12)
years.
(Prision Mayor)
Imprisonment & fine depends on the quantity gathered

DANGEROUS DRUGS BOARD • Thereafter, the persons appointed to succeed


such members shall hold office for a term of
❖ Policy-making and strategy formulating body in six (6) years and until their successors shall
the planning and formulation of policies and have been duly appointed and qualified.
programs on drug prevention and control
❖ It shall develop and adopt a comprehensive, The other twelve (12) members who shall be ex
integrated, unified and balanced national drug officio members of the Board are the following:
abuse prevention and control strategy. 1. Secretary of the Department of Justice
❖ It shall be under the Office of the President. (DOJ) or his/her representative
❖ Composed of seventeen (17) members wherein 2. Secretary of the Department of Health
three (3) of which are permanent members, the (DOH) or his/her representative;
other twelve (12) members shall be in an ex 3. Secretary of the Department of
officio capacity and the two (2) shall be regular National Defense (DND) or his/her
members representative;
4. Secretary of the Department of
Three (3) permanent members Finance (DOF) or his/her representative;
• At least seven-year training and experience in 5. Secretary of the Department of Labor
the field of dangerous drugs and in any of the and Employment (DOLE) or his/her
following fields: in law, medicine, representative;
criminology, psychology or social work 6. Secretary of the Department of the
• Appointed by the President of the Philippines Interior and Local Government
• Chairman (rank of a secretary): term of six (DILG) or his/her representative;
(6) years 7. Secretary of the Department of Social
• Undersecretary: term of four (4) years Welfare and Development (DSWD) or
• Other Undersecretary: term of two (2) his/her representative;
years

7
8. Secretary of the Department of • Apprehending team (police) with the
Foreign Affairs (DFA) or his/her confiscated materials (inventory and
representative; photograph) in the presence of the accused
9. Secretary of the Department of and representative from media personnel
Education (DepEd) or his/her from Department of Justice (Public official,
representative; representative from National Prosecution
10. Chairman of the Commission on Service and Media). The inventory and
Higher Education (CHED) or his/her photograph shall be conducted where search
representative; warrant is served.
11. Chairman of the National Youth • Within twenty-four (24) hours upon
Commission (NYC) confiscation/seizure, dangerous drugs must
12. Director General of the Philippine be submitted to the PDEA Forensic
Drug Enforcement Agency (PDEA) Laboratory for a qualitative and quantitative
examination
The two (2) regular members shall be as follows: • A certification of the forensic laboratory
• The president of the Integrated Bar of the examination results (done under oath by the
Philippines; and forensic laboratory examiner) shall be issued
• The chairman or president of a non- within twenty-four (24) hours.
government organization involved in − In case of delay: a partial laboratory
dangerous drug campaign to be appointed examination report shall be
by the President of the Philippines. provisionally issued stating therein
Permanent consultants of the Board: Director the quantities of dangerous drugs still
of the NBI and the Chief of the PNP; they shall to be examined by the forensic
attend all the meetings of the Board. laboratory. Final certification shall be
Meeting: once a week or as often as necessary at issued on the completed forensic
the discretion of the Chairman or at the call of laboratory examination on the same
any four (4) other members. The presence of nine within the next twenty-four (24)
(9) members shall constitute a quorum. hours.
• After the filing of the criminal case, the Court
SECTION 21
shall, within seventy-two (72) hours, conduct
• Custody and Disposition of Confiscated, an ocular inspection and through the PDEA
Seized, and/or Surrendered Dangerous shall within twenty-four (24) hours thereafter
Drugs, Plant Sources of Dangerous Drugs, proceed with the destruction or burning of the
Controlled Precursors and Essential same, in the presence of the accused or the
Chemicals, Instruments/Paraphernalia and/or person/s or his/her representative or counsel,
Laboratory Equipment a representative from the media and the DOJ,
• PDEA shall take charge and have custody of civil society groups and any elected public
all dangerous drugs, plant sources of official.
dangerous drugs, controlled precursors and • Board shall issue a sworn certification as to
essential chemicals, as well as the fact of destruction or burning of the
instruments/paraphernalia and/or laboratory subject item/s.
equipment so confiscated, seized and/or • The alleged offender or his counsel shall be
surrendered. allowed to personally observe all above
proceedings. In the event that the said

8
offender refuses or fail to appoint a ✓ All candidates for public office
representative, DOJ Secretary shall appoint a ❖ Issuance of False or Fraudulent Drug Test
member of PAO to represent the accused. Results
• Promulgation and judgment. ➢ Imprisonment: six (6) years and one (1) day
to twelve (12) years
DANGEROUS DRUG TEST AND RECORD ➢ Fine: One hundred thousand pesos
REQUIREMENTS (P100,000.00) to Five hundred thousand
❖ Authorized drug testing shall be done by any pesos (P500,000.00)
government forensic laboratories or by any of the ➢ Revocation of the license of the practitioner
drug testing laboratories accredited and and the closure of the drug testing center
monitored by the DOH to safeguard the quality ❖ Laboratory Examination or Test on
of test results. Apprehended/Arrested Offenders
❖ Drug test certificates issued by accredited drug ➢ Screening laboratory examination or test
testing centers shall be valid for a one-year period within twenty-four (24) hours
from the date of issue which may be used for ➢ Confirmatory test (GC-MS) within 15 days
other purposes. after (+) screening
❖ The Seminar/Workshop on the Manual of ❖ Records Required for Transactions on
Operations for Analysts of Drug Testing Dangerous Drugs and Precursors and
Laboratories is conducted by the National Essential Chemicals
Reference Laboratory – East Avenue Medical ➢ Original record of sales, purchases,
Center (NRL-EAMC) together with partner acquisitions and deliveries of dangerous
agencies (i.e. PAMET, PFDTS, HiPrecision drugs
Diagnostics, Philippine Army, etc.). ➢ Certified true copy of record covering a
* Seminar/ workshop/ proficiency training for period of six (6) months, duly signed by the
Drugs Screening → 3 to 5 days for ~P5,000 pharmacist or the owner of the drugstore,
❖ This seminar is open for licensed chemist, pharmacy or chemical establishment, shall be
medical technologist and pharmacist. forwarded to the Board within fifteen (15)
* DTA – Certified Drug Test Analyst; for days following the last day of June and
chemists, RMT, RPh December.
* IDTOMIS – system for drug testing for all ➢ A physician, dentist, veterinarian or
hospitals practitioner authorized to prescribe any
❖ The following shall be subjected to undergo drug dangerous drug shall issue the prescription
testing: therefor in one (1) original (shall be retained
✓ Applicants for driver’s license (RA 10586) by the pharmacist for a period of one (1) year)
✓ Applicants for firearm’s license and for and two (2) duplicate copies (buyer/patient
permit to carry firearms outside of residence and physician)
✓ Students of secondary and tertiary schools * Prescriptions should be in 3 copies:
(random drug testing)
✓ Officers and employees of public and private • 1 for pharmacy/pharmacists
offices • 1 for buyer/ patient
✓ Officers and members of the military, police • 1 for physician
and other law enforcement agencies
✓ All persons charged before the prosecutor’s
office with a criminal offense

9
TOXICOLOGY OF DRUGS OF ABUSE likewise, detect the time frame of using the drug
or dose of drug taken.
DRUG ABUSE OR DRUG OVERDOSE
AMPHETAMINE AND
• Prescription drugs METHAMPHETAMINE
• Over-the-counter drugs
• Illicit drugs (drug pushers/clandestine
laboratory)
• Addictive potential
• Recreational or performance enhancement
purposes: Professional, industrial, and athletic
use

LABORATORY TESTS

❖ Therapeutically used for treatment of


narcolepsy and attentional deficit disorder
❖ Stimulants with a high abuse potential
❖ Chronic use: tolerance and psychological
dependence
❖ Increases mental alertness and physical
capacity and has an anorectic property
❖ Cause the release of dopamine from the brain
DESIGNER DRUGS AND DRUGS OF ABUSE
leading to a “pleasant feeling” (so called
❖ Modified forms of established drugs of abuse “high”) among users.
❖ Analogs of either prescription pharmaceuticals or ❖ Initial effects: increased mental and physical
an illicitly abused drugs. capacity along with a perception of well
❖ Modifications in structure some of which are being
quite minor, are enough to create new compound, ❖ Late effects: restlessness, irritability and
which is not specifically banned by current possible psychosis
legislation ❖ Overdose: hypertension, cardiac
❖ Synthetic derivatives of heroin and arrhythmias, convulsions and possible death
amphetamines are currently available through ❖ Compounds chemically related to
illicit sources amphetamines:
❖ Almost all drugs of abuse are basic drugs (amine − Over-the counter medications (
derivatives) which contain benzene rings ephedrine, pseudoephedrine and
❖ Act directly on dopaminergic neurotransmitter phenylpropanolamine)
systems, especially the limbic system (small Other names:
brain)
❖ Positive drug screening test cannot differentiate ✓ Chalk
casual user from chronic or habitual user, ✓ Crystal
✓ Chemical ice

10
✓ Glass • Beans
✓ Speed • Candy
✓ Crank ice • Dancing shoes
✓ Tina • Disco biscuits
✓ Siopao • Doves
✓ Ubas • E-bomb
3,4-METHELYNEDIOXYMETHAMPHETAMINE • Egg rolls
• Happy pill
❖ Illicit amphetamine derivative • Hug drug
❖ MDMA or Ecstasy • Love drug
❖ Club culture in the 1990s
• Malcolm
❖ High potential for abuse
• Scooby snacks
❖ 200 designer analogues produce effects
• Skittles
comparable to those of MDMA
❖ Administration: oral in tablets of 50- 150 • Thizz
mg, inhalation, injection, or smoking • Vitamin E or X
• Vowel
Desired Effects:
ANABOLIC STEROIDS
1. Hallucinations
2. Euphoria
3. Emphatic
4. Emotional responses
5. Increased visual and tactile sensitivity
Adverse effects:
1. Headaches
2. Nausea
3. Vomiting ❖ Chemically associated to the male hormone
4. Anxiety testosterone (dihydrotestosterone and
5. Agitation testosterone)
6. Impaired memory ❖ Developed in 1930s: therapy for male
7. Violent behavior hypogonadism
8. Tachycardia ❖ Use of these compounds in healthy subjects:
9. Hypertension improves athletic performance by increasing
10. Respiratory depression muscle mass
11. Seizures ❖ Adverse effects: testicular atrophy, sterility and
12. Hyperthermia impotence to males and development of
13. Cardiac toxicity masculine traits, breast reduction and sterility to
14. Liver toxicity females
15. Renal failure ACUTE TOXIC EFFECTS:
✓ Inconsistent formulation
Other names:
✓ High dosages
• X, E pr XTC ✓ Impurities
• Adam

11
CHRONIC USE: • Bud
✓ Toxic hepatitis • Cannabis
✓ Accelerated atherosclerosis and abnormal • Reefer
aggregation of platelets → stroke and • Indo
myocardial infarction • Hash
✓ Enlargement of the heart → ischemia → • Herb
cardiac arrhythmias → sudden death
• Ganja
CANNABINOIDS • Mary Jane
• Loco weed
• Gangster
• Pot

COCAINE

❖ Psychoactive compounds found in marijuana


❖ Most potent component and most abundant:
Tetrahydrocannabinol (THC)
❖ Lipophilic substance
❖ Rapidly removed from the circulation by passive
distribution into hydrophobic compartments ❖ An alkaloid salt (Ecgonine)
(adipose tissues, easily enters the brain) ❖ Derived from coca plant (Erythroxylum)
❖ Induces a sense of well-being and euphoria ❖ Used as a local anesthetic for nasopharyngeal
(hallucinogen) surgery
❖ Naturally occurring cannabinoids: marijuana ❖ High abuse potential
and hashish ❖ Higher circulating concentrations
Administration: smoked or ingested ❖ Potent CNS stimulator, elicits excitement and
Effects: euphoria
✓ Sense of well being
✓ Euphoria * Most abundant drugs in the USA
✓ Impairment of short-term memory and *Insufflation = sinisinghot
intellectual function
Major urinary metabolite: Administration:
• 11-nor-tetrahydrocannabinol-9- • Direct: insufflation or intravenous injection
carboxylic acid (THC-COOH) (presents greatest hazard, closely followed by
Detected in urine for 3-5 days after a single use smoking)
Up to 4 weeks in a chronic, heavy consumer after • Inhaled by vapor when smoked in free base
abstinence form (crack)
Other names: Acute toxicity:
• Weed • Hypertension
• Grass • Arrhythmia
• Buddha • Seizure

12
• Myocardial infarction Heroin

OPIATES • Highly addictive (true physical dependence)


• Crosses the blood-brain barrier (elevated
levels at the CNS)
• Taken by IV administration

SEDATIVE HYPNOTICS

❖ Capable of analgesia, sedation and anesthesia


❖ Derived chemically from opium poppy
❖ High abuse potential
❖ Chronic use leads to tolerance with physical and
psychological dependence
Naturally occurring opiates:
• Opium ❖ Tranquilizers
• Morphine ❖ CNS depressants
• Codeine (antitussive drug) ❖ Wide range of therapeutic roles and most
• Chemically modified forms: common type of sedative hypnotic abused:
Barbiturates and Benzodiazepines (toxicity of
• Heroin
this agent is initiated by ethanol)
• Hydromorphone (Dalaudid)
Commonly abused barbiturates:
• Oxycodone (Percodan)
• Secobarbital
• Common synthetic opiates:
• Pentobarbital
• Meperidine (Demerol)
• Phenobarbital
• Methadone (Dolophine)
• Thiopental
• Propoxyphene (Darvon)
Commonly abused benzodiazepines:
• Pentazocine (Talwin)
• Diazepam (Valium)
• Fentanyl (Sublimaze)
• Chlordiazepoxide (Librium)
PROPERTIES OF MORPHINE AND HEROIN
• Lorazepam (Ativan)
Morphine
• Metabolite of heroin
• Powerful analgesic
• Used in the treatment of congestive heart
failure
• Increases liver and pancreatic enzymes
*Pain management for cancer patients

13
LYSERGIC ACID DIETHYLAMIDE (LSD,
LYSERGIDE)

Effects:
• Sympathetic effects: hypertension,
tachycardia, mydriasis and piloerection are
the initial symptoms
• Psychic effects
• Visual effects: hallucinations, blurred or
“undulating” vision and synesthesia
• Panic reactions such as “bad trip” (most
common adverse reaction)
• Prolonged psychotic episodes and flashbacks

*Random drug test for school = Free


*Drug test (s) in hospitals = ~P700 – P800
* Confirmatory test = ~P1500

14
MEDICAL TECHNOLOGY LAWS AND BIOETHICS
OUR LADY OF FATIMA UNIVERSITY
2ND YEAR, 2ND SEMESTER
Final Term
Ethics is a Natural Science

Ethics AND Health care ➢ It employs the power human reason which is
purely a natural process. It is not based on the
(Lesson 10- Week 15)
teaching of the Catholic Church or any systems
TOPIC OUTLINE: of belief, nor it is based on the Bible.
Ethics
Morality
❖ Ethics is the science of human acts with the
Ethics/Moral Philosophy and Moral
Theology reference to right and wrong.
Division of Ethics ❖ Ethics is the study of the rectitude of human
Bioethics and Health Ethics conduct.
Health Care ❖ Ethics is the scientific inquiry of the principles
Moral Principles in Health Care of morality.
Pointers for a Health Care Practitioner
MORALITY

WHAT IS ETHICS? MORALITY – is that quality of human acts where


the acts could either be good or right, evil or
ETHICS - a philosophical and practical science that wrong. This quality indicates and determines
deals with the study of the morality of human acts whether the kind of human act that is performed is
or human conduct. good or bad.
Ethics as a Science Ethics & Morality
➢ As a science, ethics comprises data on the Relation Distinction
morality of human acts that are put together and a) Both ethics and a) Ethics pertains to
arranged in order along with the causes and morality deal with the knowledge of
reasons by which said data are held to be factual human act or human what to study about-
conduct. that is the goodness
thereby making a systematized body of
b) Ethics studies about or evilness of a
knowledge. morality. human act;
Ethics as a Philosophical Science c) Morality gives Morality pertains
ethics a perspective to the application of
➢ Ethics deals with the ultimacy of the cause, of what to study this knowledge.
principle, and truth concerning the morality of about – that is the b) Ethics provides
human conduct in the light of human reason rectitude of whether learning about the
alone. an act is good or morality of a human
bad. conduct; Morality
Ethics as a Practical Science d) Morality provides provides ways in
ethics with a quality practicing what is
➢ Ethics provides a body of knowledge which is not
that determines and learned.
only a body that enriches and sustains the
distinguishes right c) Ethics is the
intellect with more learning but most conduct from wrong ‘word’; Morality is
importantly, a body of knowledge which, by conduct. the ‘flesh’.
nature of its learning, is applied in the d) Ethics indicates the
performance of human conduct. ‘theory’; Morality

1
indicates the HEALTH ETHICS
‘practice’
− A science that deals with the study of the morality
of human conduct concerning health and health
ETHICS/MORAL PHILOSOPHY AND care. Health care pertains to medical services,
MORAL THEOLOGY nursing care, and all other types of health services
given by health care practitioners.
Sources of Ethics/Moral Philosophy
− Employed to regulate human conduct in the
• Human reason as its primary source practice of health care so that good may be done
• Contemporary and historical experiences and evil may be avoided thereby ensuring the
1. Personal experiences purpose of health care which delves on the
2. Experiences of others alleviation of suffering, prevention of sickness
and promotion of health.
DIVISIONS OF ETHICS
Bioethics & Health Ethics
Ethics has two principal parts: Relation Distinction
a) Both are concerned a) Health ethics is
1. General Ethics – presents truths about human about health and concerned about life
acts, and from these truths deduces the general life. only in relation to
principles of morality. b) Both regulate health; bioethics is
2. Special Ethics - is applied ethics. It applies the human conduct by concerned not just
principles of general ethics in different means of moral about health but
departments of human activity, both individual principles in also about other
and social. relation to health fields in relation to
Special ethics is fragmented into: and life. life.
a) Individual Ethics c) Health ethics is a b) Health ethics
− as regards God part of bioethics regulates human
conduct in the
− as regards self
practice of health
− as regards fellowmen care; bioethics
b) Social Ethics regulates human
− in the family conduct not only in
− in the state the practice of
− in the world (International Ethics) health care but also
in all aspects of
BIOETHICS AND HEALTH ETHICS human life.
c) Bioethics is not a
BIOETHICS part of health ethics.
− Refer to a new field devoted to human survival It has an
encompassing
and an improved quality of life (Van Rensselaer
scope of discipline.
Potter).
− A science that deals with the study of the morality
of human conduct concerning human life in all its HEALTH CARE
aspects from the moment of its conception to its
natural end. HEALTH CARE – is the prevention, treatment, and
management of illness and the preservation of mental

2
and physical well-being through the services offered PRINCIPLE OF NON- MALEFICENCE
by the medical and allied health professions.
❖ Engraved in the natural law, the principle of non-
❖ Ethics is essential to the practice of health maleficence provides that evil or harm should not
care for it provides knowledge of the morality be inflicted either on oneself or on others.
of an act and serves as a guiding principle for ❖ This fundamental moral principle binds and
health care practitioners. urges everyone to avoid inflicting harm as a
moral obligation.
MORAL PRINCIPLES IN HEALTH CARE
❖ In health care practice, it is also the primary
❖ Principle is that from which something obligation of health care providers to make sure
proceeds in any manner, whatsoever. that there is no harm exacted on their patients in
Example: The principle of smoke is fire or a whatever form.
cigarette butt. It is fire or cigarette butt from
Violations of the principle of non-maleficence
which the smoke proceeds.
❖ A moral principle refers to a fundamental  Physically harming a person as in suicide,
rule of moral law containing certain truth abortion, infanticide, mutilation, torture and
from which knowledge of a definite moral violence;
action for performance proceeds along with  Exposing a person to physical harm as in
the provision of solution to specific moral subjecting a person to unnecessary treatment or
problems or issues. to a dangerous procedure without a
commensurate important goal; and
PRINCIPLE OF BENEFICENCE  Harming a person's reputation, honor, property or
❖ Inscribed in the natural law, the principle of interests as by revealing confidential
beneficence provides that good must be done information.
either to oneself or to others. PRINCIPLE OF DOUBLE EFFECT
❖ This fundamental moral principle binds and
urges everyone to do what is good and perform ❖ Sometimes it is permissible to cause a harm as a
for good as a moral obligation. side effect (or “double effect”) of bringing about
❖ In health care milieu, patients are in need most of a good result even though it would not be
what is good for them. All the necessary and permissible to cause such a harm as a means to
proper means of care should be given in an effort bringing about the same good end.
to serve not only the biological and pathological
The Four Conditions
needs of the patients but also their psychological
and spiritual longings. 1. The act must be good in itself, or at least,
❖ Pathological and biological care: giving morally indifferent.
appropriate nourishment and fluids, providing air 2. The good effect must directly proceed from
passage, administering medications and the act itself and not from the evil effect.
application of necessary medical equipment. 3. There must be sufficient reason for the
❖ Psychological and spiritual needs: counseling performance of an act in its attainment of the
therapeutic communication, touch and presence, good effect.
calling of the priest for the administration of the 4. The motive of the agent must be holy and
Sacraments of Confession, Anointing of the Sick, honest.
and the Holy Viaticum for Catholics.

3
When Can the Principle of Double Effect not be JUSTICE – the rendering of what is one's due. A
Invoked? person who is justly doing an act to another person
gives the latter what is his due.
• When the act by its nature is evil.
• When the good effect directly proceeds from RIGHT – a moral power of performing, of
the evil effect and not from the act itself. possessing, or of requiring something which is due.
• When there is no sufficient reason for the This moral power has to be upheld and respected. It
performance of an act with two effects, one- refers either to natural rights (right to life and to the
good, the other- evil. pursuit of happiness) as incumbent upon the nature
• When the motive of the agent is not honest. and dignity of the human person, or rights granted by
positive law whether Divine or human (right to
PRINCIPLE OF INDIRECT VOLUNTARY vote).
ACT
DUTY – defined as a moral obligation incumbent
❖ An act that is directly intended with an evil effect upon a person of doing or omitting (avoiding)
that is not directly intended though foreseen or something. Duty as a moral obligation to do good and
foreseeable. to avoid evil that which protects one’s rights from
being violated.
The Three Conditions
Main Duties and Obligations of Health Care
1. The evil effect must be foreseen or
Practitioners
foreseeable in the performance of the act at
least in a general way. ✓ Preservation of life and health
2. There must be freedom to choose not to do ✓ Protection of bodily integrity from harm
the act which is the cause of the evil effect. ✓ Respect for human dignity
3. Refraining from doing the act which is the
DISTRIBUTIVE JUSTICE
cause of the evil effect holds the agent
morally bound. − Pertains to a fair scheme of distributing
society's benefits and burdens to its members.
PRINCIPLE OF STEWARDSHIP
− In health care milieu, benefits refer to various
❖ Refers to the expression of one's responsibility to health care services, while burdens include
take care of, nurture and cultivate what has been the necessary payment for the delivery of
entrusted to him. health care and participation in medical
❖ In health care practice, stewardship refers to the experimental research.
execution of responsibility of the health care − Distribution of the scarce health care
practitioners to look after, provide necessary resources can be a source of acts of injustice
health care services, and promote the health and if it does not provide equal opportunities.
life of those entrusted to their care.
TWO ALTERNATIVES
PRINCIPLE OF JUSTICE
1. The Utilitarian Alternatives – maximizing
❖ Refers to a moral principle by which certain strategies to achieve the greatest amount of good
actions are determined and deemed as just or or minimizing strategies to reduce the amount of
unjust, as due or undue. potential harm.
o The medical success principle: gives
priority to those for whom treatment has

4
the highest probability of medical burdens they are to undergo as they accept and
success. submit for health care intervention.
o The principle of immediate usefulness:
DUE BURDEN – refers to a certain sense of pain or
gives priority to the candidate who is of
discomfort necessarily associated with one's
greatest immediate service to the
submission for health care intervention.
larger group under the circumstances.
o The principle of conservation: gives Ex: buying medicines at the pharmacy as
priority to those candidates who require prescribed, the pain brought about by
proportionally smaller amount of intravenous insertion and injection
resources and therefore more lives would
be saved. UNDUE BURDEN – refers to a certain sense of pain
o The parental role principle: gives or discomfort brought about by a certain medical,
priority to those who have the largest experimental or surgical proceeding which is of no
responsibility to dependents. direct benefit to the subject. It may be deemed
o The principle of general social value: unnecessary as far as the subject is concerned.
gives priority to those believed to have Ex: donation of one’s organ, paying for
the greatest general social worth thus somebody else’s hospital bill
leading to the good society.
2. The Egalitarian Alternatives – represent PRINCIPLE OF COOPERATION
maintaining or restoring the equality of the
❖ COOPERATION comes from the Latin word
person in need.
cum which means ‘with’, and operari which
a. The principle of saving no one: gives
means ‘to work’.
priority to no one because not all can be
❖ Cooperation is working with another in the
saved.
performance of an action.
b. The principle of medical neediness:
❖ The principle of cooperation pertains to the evil
gives priority to the candidates with
of an action shared together by individuals in the
most pressing medical needs,
achievement of an evil practice whose culpability
c. The principle of general neediness:
may vary according to the gravity of the act
gives priority to the most helpless or
partaken.
generally neediest in an attempt to bring
them nearly as possible to the level of Various Degrees of Cooperation
well-being equal to that enjoyed by
Formal and Material
others.
d. The principle of first come first served 1. Formal Cooperation - consists of an explicit
basis: gives priority to those who arrive intention and willingness for the evil act. The one
first. formally cooperating categorically wills and
e. The principle of random selection: intends the evil action.
gives priority to those selected by 2. Material Cooperation - consists of an act other
chance or random. than the evil act itself but facilitates and
contributes to its achievement. The one
HEALTH CARE BURDENS materially cooperating may provide means apart
❖ In accordance with the principle of justice to let from the evil act itself which is used to carry out
the patients know both the due and undue the performance of an evil act.

5
Direct and Indirect competently be done by an individual or lower
group.
1. Direct Cooperation - consists of direct
participation in the performance of an evil act. Moral Principles And Health Care
The one directly cooperating gets involved by
openly and straightforwardly taking part in the ❖ Observance of moral principles in the practice of
practice of an evil action. health care is essential. It guides and directs the
2. Indirect Cooperation - consists of an act that is health care delivery system towards the
not intimately connected with the performance of fulfillment of the norms of morality, natural law,
an evil act as in formal and direct cooperation but and God's Eternal Law.
whose effect may have an indirect bearing upon ❖ Moral principles provide enlightenment of
it. health care issues that seem to be vague as to
their moral acceptability affecting not only the
Proximate and Remote kind of health care system that is delivered but
1. Proximate Cooperation – consists of an act that also the moral fiber of both the health care
is intimately linked with the performance of an practitioners and the clients.
evil action due to its close bearing. Pointers For A Health Care Practitioner
2. Remote Cooperation - consists of an act with a
distant bearing upon or connection with the The following pointers are given for consideration:
execution of an evil act.
1. Observe and apply the different moral
PRINCIPLE OF TOTALITY principles to specific moral issues and
problems that beset the practice of health care
❖ The whole implies the existence of its parts. The profession today.
existence of parts indicates the existence of the 2. Do justice by carrying out your duties and
whole. Parts as such should continuously be obligations inherent in your profession
connected with the whole of which they are parts without any mental reservations, by
without which they cease to be. treating your patients according to their
❖ If a part becomes problematic, it affects the needs, and by providing the necessary means
whole. So, it has to be treated in order to restore of care that does not just address pathological
its mode of existence as part of the whole. problems but also emotional and spiritual
❖ If the state of condition and continuous existence longings.
as part pose a threat to do more harm than good 3. Consider yourself as steward of your
leading to the destruction of the whole, it will be patients, who will always be there to look
removed and sacrificed for the sake of the whole. after their welfare, to give due care, and to
avoid any health care measures that are
PRINCIPLE OF SUBSIDIARITY
destructive of human life and dignity.
❖ Means that what an individual, lower or smaller
group can achieve within his/her or its capacity
should not be taken away and transmitted to the
custody and performance of a higher or bigger
group.
❖ Likewise, no bigger or higher group can arrogate
to itself functions that can capably and

6
MEDICAL TECHNOLOGY LAWS AND BIOETHICS
OUR LADY OF FATIMA UNIVERSITY
2ND YEAR, 2ND SEMESTER
Final Term
Healthcare profession ❖ The relationship between a healthcare
provider and a patient is not a contract —
(Lesson 11- Week 16) likened to a seller and a buyer of goods. It is
TOPIC OUTLINE: a covenant — a trusted caring service
Healthcare Profession between a healthcare giver who offers help
Basic Qualities of a Healthcare and dependent patient who needs and
Practitioner receives it.
Patient and Healthcare Practitioner ❖ The patient trusts that the healthcare provider
will be his advocate and will always have the
Healthcare Professional Relationship patient's best interest as his first priority.
Board of Medical Technology Code of Furthermore, this trust is characterized by
Ethics mutual honesty, openness and
Healthcare Practitioner- Client understanding, and information that is
Relationship freely given and exchanged.
Basic Attitudes of a Healthcare ❖ It is a caring relationship wherein healthcare
Practitioner provider and receiver have a sense of
Basic Unethical and Unprofessional oneness, fulfilment, and growth, assisting
Practices each other and at the same time recognizing
Universal Principles of Biomedical Ethics
each other's importance, uniqueness
Virtues of The Healthcare Provider complexity feelings, and needs. Each one
Bioethical Issues helps the other find a voice and be heard so
Abortion that both may be enriched.
Contraception BASIC QUALITIES OF A HEALTHCARE
Family Planning PRACTITIONER
Sterilization 1. Self-knowledge and self-acceptance
Human Cloning ➢ How well do you know yourself?
Mutilation ➢ The nature and function of a healthcare
practitioner are in the harmony with God-
Suicide
given talents, field of interest, resources and
Euthanasia personal values.
2. Pure and clear motivation
HEALTH CARE PROFESSION ➢ What makes me decide to take the course in
healthcare?
❖ The healthcare profession is a special ➢ What and who are the factors that contribute
calling, a service characterized by a trusting to my decision making to take up the course?
and caring relationship which cannot be ➢ Do I really like the course?
measured in momentary terms. ➢ What are the reasons why I believe I am
❖ Providing healthcare is not a career like meant for the career?
accountancy or engineering. It is a vocation 3. Strong will and determination
more like priesthood, a healing ministry. ➢ A strong will or a chosen will for a chosen
profession develops when motivation are
1
cleared up and purified necessitating HEALTHCARE PROFESSIONAL
sufficient knowledge and acceptance. RELATIONSHIP
PATIENT AND HEALTHCARE ❖ It is established in connection with the
PRACTITIONER performance of works as an occupation that is
meant to cater the healthcare needs of the client.
Patient
❖ A code of ethics has been established under pain
• Every person has an obligation to care for his of appropriate.
own health, therefore he has the right to seek ❖ Sanction governing human and professional
and receive healthcare. conduct of healthcare practitioner.
• A sick individual becomes a patient if:
BOARD OF MEDICAL TECHNOLOGY CODE
✓ He admits that he is sick.
OF ETHICS
✓ He can no longer take care of himself.
✓ He asks for help or aid. As I enter into the practice of Medical Technology,
• Because the patient is sick and unable to heal
❖ I shall accept the responsibilities inherent to
himself, a patient is vulnerable.
being a professional;
• Patient should accept the responsibility for
❖ I shall uphold the law and shall not engage in
his care, cooperate by telling the truth and
illegal work nor cooperate with anyone so
doing best to follow the instruction.
engaged; I shall avoid associating or being
• Patients must give respect, gratitude, and
identified with any enterprise of questionable
compensation to his healthcare practitioner.
character;
Healthcare Practitioner ❖ I shall work and act in a strict spirit of fairness to
employer, clients, contractors, employees and in
• The one who has acquired advanced, a spirit of personal helpfulness and fraternity
specialized and systematic training and toward other members of the profession;
experience in knowledge of healthcare along ❖ I shall use only honorable means of competition
with its various specific scientific for professional employment or services and
specialization and techniques. shall refrain from unfairly injuring, directly or
• Healthcare practitioner protects, gives care indirectly, the professional reputation, projects or
and also teaches how to care for himself. business of a fellow medical technologist;
• He becomes one committed to healthcare, ❖ I shall accept employment from more than one
invested authority but with corresponding employer only when there is no conflict of
responsibilities to patients, his profession, interest;
and the society. ❖ I shall perform professional work in a manner
• He must be the patient advocate, competent that merits full confidence and trust carried out
both to scientific and interpersonal skills and with absolute reliability, accuracy, fairness and
must always be understanding, humane and honesty;
compassionate. ❖ I shall review the professional work of other
• As an authority, he must contribute to medical technologists, when requested, fairly and
knowledge, conduct himself in an ethical in confidence whether they are subordinates or
profession and always serve as a role model. employees, authors of proposals for grants or
contracts, authors of technical papers or other
publications or involved in litigation;

2
❖ I shall advance the profession by exchanging Courteous
general information and experience with fellow
❖ Conveys recognition and acknowledgement
medical technologists and other professionals
of worth, uniqueness and preciousness.
and by contributing to the work of professional
❖ Observes patient's rights by doing good and
organizations;
avoiding harm.
❖ I shall restrict my praises, criticisms, views and
opinions within constructive limits and shall not Affirming, accepting and loving
use the knowledge I know for selfish ends;
❖ I shall treat any information I acquired about ❖ Healthcare practitioner allows the patient to
individuals in the course of my work as strictly ventilate his biases, prejudices, his needs and
confidential, and may be divulged only to problems.
authorized persons or entities or with consent of BASIC UNETHICAL AND
the individual when necessary; UNPROFESSIONAL PRACTICES
❖ I shall report any infractions of these principles
of professional conduct to the authorities 1. Sizing up one’s professional capacity before
responsible of enforcement of applicable laws or others.
regulations, or to the Ethics Committee of the 2. Performing actions beyond one’s professional
Philippine Association of Medical Technologists functions and capacity.
as may be appropriate. 3. Having illicit and illegal sexual relationship with
a client.
To these principles, I hereby subscribe and pledge to 4. Embarrassing a colleague or subordinate before a
conduct myself at all times in a manner befitting the client or patient.
dignity of my profession. 5. Breaking the rules on confidentiality and secrecy.
HEALTHCARE PRACTITIONER - CLIENT 6. Fabricating patients record and medical
RELATIONSHIP certificates for any purposes.
7. Engaging in fraudulent acts unbecoming of a
Therapeutic relationship professional.
❖ It may develop even more meaningful level MALPRACTICE VS. NEGLIGENCE
transcending what is merely mechanical into
commitment and accountability with love, MALPRACTICE
trust, concern and care for each other. ❖ Refers to the injurious or unprofessional
BASIC ATTITUDES OF A HEALTHCARE treatment or culpable neglect of a patient by
PRACTITIONER a healthcare practitioner.
❖ Ex: anesthesia error, mistake during
Caring and warm childbirth, surgical errors,
medication/treatment errors and diagnostic
❖ Feeling of emotional closeness in contrast to
errors.
an impersonal approach.
➢ Caring – conveys deep and genuine concern NEGLIGENCE
for the person.
➢ Comforting – one who provides the clients ❖ Failure to use reasonable amount of care
relief from discomfort. when such failure result in injury and damage
to another.

3
❖ Ex: poor follow-up or aftercare, failure to ➢ The power to act your decisions.
order proper testing and failure to recognize ➢ A respect to individual autonomy of
symptoms. others.
DEFAMATION Informed Consent
❖ It is the uttering or publishing of slanderous ❖ Permission obtained from a patient to
words with the purpose of injuring another’s perform a specific test or procedure.
reputation. ❖ It is required before most invasive procedures
❖ Slander – utterance of false statement in the are performed and before a patient is
presence of another person that is damaging admitted to a research study.
to a third person ❖ The document used must be written in a
❖ Libel – a malicious writing or representation language understood by the patient and be
which brings its objects into contempt or dated and signed by the patient and at least
expose him to public decision. one witness.
❖ Voluntary
UNIVERSAL PRINCIPLES OF BIOMEDICAL ❖ By law, informed consent must be obtained
ETHICS more than a given number of days or hours
1. Veracity – binds the healthcare practitioner and before certain procedures, including
the patient in an association of the truth. therapeutic abortion and sterilization, and
• The patient tells the truth in order that must always be obtained when the patient is
appropriate care can be provided. fully competent.
• The healthcare practitioner needs to Functions of Informed Consent:
disclose factual information so that the
patient can exercise personal decision ❖ Protective – to safeguard against intrusions
making. of integrity
• The patient has the right to expect a ❖ Participative – to be involved in medical
higher level of truthfulness from the decision making
healthcare practitioners than others with Proxy Consent
whom they deal.
2. Autonomy – autos (self), nomos (governance) ❖ The patient’s family, guardian, or
• The capacity for self-determination. representative that provides the informed
consent.
• Implies that one should be free from
❖ Decisions of the proxy should be based on
coercion in deciding to act, and that
what the patient would have chosen when he
others are obliged to protect
has been competent.
confidentiality, respect, privacy, and tell
the truth. Elements of Informed Consent:
• It is exercised through the process of
❖ Knowledge – information disclosure by the
obtaining informed consent.
healthcare provider such as benefits, possible
• However, it does not imply that one must
risks, alternative options, and other information
cooperate with another action in order to
relevant must be given to the patient.
respect that individual autonomy.
❖ Comprehension by subject – information must
Basic elements of autonomy: be given in word and manner understandable by
the patient.
➢ The ability to decide.
4
❖ Consent 7. Role Fidelity
− Subject Competence: the subject must be ❖ Whatever the assigned role, the ethics of
able to make decisions based on rational health care require that the practitioner
reasons. practice faithfully within the constraint of the
− Subject freedom: the subject must be able to role.
choose and act without undue pressure of ❖ Acceptable practices are contained and
time, emotional upset, confusion, persuasion, prescribed by the scope of practice of the
threat, deception, manipulation, fear, or other state legislation that enables that profession's
forms of control by others. practice.
3. Beneficence
VIRTUES OF THE HEALTHCARE
❖ Traditionally understood as the “first
PROVIDER
principle of morality”.
❖ It means “to do good and to provide a ❖ The manner healthcare is delivered often rests on
benefit” the kind of person the healthcare provider is.
❖ Acts of mercy and charity. Actions intrinsically neutral become good or bad,
❖ It hinges on other duties such as fair play, helpful or harmful depending on the person
keeping promises, role commitments and concerned. A patient trusts or mistrust depending
reciprocity. on what he thinks of a healthcare provider's
4. Non-maleficence character.
❖ Means to do no, to prevent, to remove or not ❖ Virtues are acquired habits or dispositions to do
to risk harm. (doing no harm/doing no evil) what is morally right. They are traits of character
❖ "Primum non nocere”, first do no harm. that dispose its possessor to act in accordance
❖ It makes action almost impossible in a world with moral principles, rules and ideas. They
where even the best action may have some catalyze action.
harmful results. ❖ Fidelity – is faithfulness in the relationship of
5. Confidentiality trust every patient must know that his healthcare
❖ Important aspect of trust that the patient place giver will keep ha promises and keep the patient's
in health care professionals. best interest first in his mind.
❖ If the patient felt that information in regard to ❖ Honesty – is truthfulness; It is telling the
his body or condition was subject of public patient, the family colleagues and society the
conversion, a great barrier would exist truth about an illness, its nature, prognosis,
between the patient and the healthcare effectivity of care and research findings.
provider. ❖ Integrity – is wholeness. It is acting in the same
❖ Breaching of confidentiality has serious way ones says he should act. A healthcare
complications. It threatens to harm patients, provider who tells his patient smoking is bad
professions, and society, which depends on should himself not smoke.
the service we provide. ❖ Humility –is recognizing one's capabilities and
6. Justice limitations. It is doing one's best and asking for
❖ Also termed as “fairness” help as needed. It is accepting deserved praise
❖ Means to give to each one what he deserves graciously and denying undeserved praise. It is
or what is his due. recognizing that the patient knows what is best
❖ But man, lives in a finite world. There are for himself.
limits to funds, medical supplies, healthcare
services.

5
❖ Respect – means paying attention to others. It is 2. DILATION AND CURETTAGE (D&C)
listening attentively to a patient's complaints or a ABORTION
colleague's opinion. ❖ Employed during the 1st trimester of
❖ Compassion – is loving kindness, a feeling for pregnancy. A sharp looped knife or curette
those who suffer. It is self - sacrifice voluntary (sharp curettage) is inserted into the uterus to
given for the benefit of another or given with no scrape its walls. Then, the lodging baby is cut
hope of return, gain, recognition, or payment but apart and its bodily parts are removed and
given because the other's needs are greater. It is checked for completeness.
leaving the comforts of home to sit with a dying 3. DILATION AND EVACUATION (D&E)
patient. ABORTION
❖ Prudence – is foresight: a habitual ❖ Commonly used during the 1st half of second
deliberateness, caution and circumspection in trimester (13-20 weeks). Usually the
action. It is “to look before you leap” or to abortionist cuts off one or more of the baby’s
consider how different options may affect others limbs and waits until he or she bleeds to death
before making decision. before proceeding with the abortion. In case
❖ Courage – is doing what one sees as right of larger babies, big forceps are used to crush
without undue fear or standing up against what their heads and bodies inside the uterus. The
one sees as wrong even if it means standing up bodily parts torn into pieces pass through the
alone. cervix and are removed.
4. SALINE ABORTION
BIOETHICAL ISSUES ❖ Also known as “intra-amniotic injection”
ABORTION or “saline solution method” utilized during
the 2nd trimester and early 3rd trimester.
❖ It is the termination of pregnancy by the Withdrawal of 200 milliliters of amniotic
removal or expulsion from the uterus of a fetus or fluid from amniotic sac. The said fluid is
embryo prior to viability. replaced with saline or urea solution. The
❖ An abortion can occur spontaneously, in which baby breathes in and swallows this
case it is usually called a miscarriage, or it can be concentration and dies painfully from salt
purposely induced. poisoning, dehydration, brain hemorrhage
❖ The term abortion most commonly refers to the and convulsions. While dying, the baby
induced abortion of a human pregnancy. suffers extreme pain brought about by the salt
solution as it burns off the outer layer of
DIFFERENT METHODS OF SURGICAL
his/her skin.
ABORTION
5. DILATION AND EXTRACTION (D&X)
1. SUCTION ABORTION ABORTION
❖ Also called ‘suction curettage’. Is ❖ Also called “partial-birth abortion”. This
appropriately done during the 1st trimester up method of abortion is usually intended for a
to 16 weeks so far. The abortionist begins by pre-born baby who has already attained the
dilating the cervix, then he inserts a suction late 2nd and 3rd trimester of gestational age.
curette consisting of a hollow tube with a Guided by ultrasound, the abortionist uses
sharp tip into the cervix and then into the forceps to twist one of the baby’s legs and
uterus. The suction machine tears the pull it out through the birth canal and delivers
developing baby apart, sucks the pieces the entire body except the head. Afterwards,
through the tube and deposits them into a bag. puncturing the back of the baby’s head with a
sharp scissor. Finally, a suction tube is
6
inserted to suck out the brain of the baby CONTRACEPTION
causing the skull to collapse.
6. PROSTAGLANDIN ABORTION ❖ Birth control, also known as contraception
❖ Performed during late 2nd and 3rd trimester of and fertility control, refers to methods or
gestation. A prostaglandin hormone devices used to prevent pregnancy. Planning
containing about 8 milliliters is injected into and provision of birth control is called family
the uterine muscle which contracts to expel planning.
the baby in an artificially-induced and ❖ Safe sex, such as the use of male or female
extremely –violent premature labor that takes condoms, can also help prevent transmission
about 20 hours. of sexually transmitted diseases.
7. HYSTEROTOMY ABORTION FAMILY PLANNING
❖ Caesarian section done during the last
trimester of pregnancy when other types of ❖ In its broadest sense, it is a program crafted
abortion are dangerous to the mother. The to promote responsible parenthood.
uterus is surgically opened and the baby is ❖ In its strict sense, it refers to a program which
lifted out. The baby is then either left to die enables couple, and individuals to decide
or deliberately killed. freely and responsibly the number and
8. INTER-CARDIAC INJECTION spacing of their children and to have the
ABORTION information and means to carry out their
❖ It is employed during about sixteen weeks. decisions, and to have informed choice and
An amount of potassium chloride or some access to a full range of safe, legal and
other fluid is injected to the baby’s heart with effective family planning methods,
the aid of ultrasound imagery, causing the techniques and devices.
baby to have an immediate heart attack. After
Characteristics of a Valid Family Planning:
a period of days, the dead baby is delivered.
➢ It must be voluntary.
ABORTION
➢ No life must be destroyed.
PRO ANTI
➢ Public welfare must be amply protected.
• A woman has the • Deliberately killing
right to decide what innocent human ➢ For married couples, sexual relationship must
she can and can't do beings is wrong. not be impaired.
with her body. • A fetus is an Issues:
• The fetus exists innocent human
inside a woman's being. ➢ Does it provide equality to protection of life
body. • Abortion is the both for the mother and the unborn child from
• A woman has the deliberate killing of conception?
right to decide a fetus. ➢ Does the use of contraceptives promote
whether the fetus • Therefore, abortion abortion?
remains in her body. is the deliberate
• Therefore, a killing of an FAMILY PLANNING
pregnant woman innocent human PRO ANTI
has the right to abort being. • It facilitates • This will play into
the fetus. • Therefore, abortion responsible the hands of pro-
is wrong. parenthood. abortion camp.
• Helps couples and • As cheap condoms
parents achieve fail, there will be an

7
• their desired family increase in of animals, with added effects such as docility,
size. unwanted greatly reduced sexual behavior, and faster weight
• Reduce incidence of pregnancies among gain (which is desirable in some cases, for example
teenage pregnancy. the poor. to accelerate meat production).
• Enable government • Rapid growth of
to achieve a population does not Moral Issues on Sterilization
balanced correspond to the
❖ The Catholic church has strongly condemned all
distribution. increase in food
artificial methods of Contraception (apposition
• Basis: Pro-choice production.
also held by most Protestant churches up to 1930,
• Basis: Pro-natural
procreation when the Anglican church voted for change).
❖ This includes the contraceptive pill, condoms and
also medical procedures such as vasectomy and
STERILIZATION sterilization. In fact, the church regards
contraception as mortally sinful. The official
❖ A surgical technique leaving a male or female
position is stated in the papal encyclical
unable to reproduce.
Humanae Vitae issued by Pope Paul VI in 1968.
❖ It is a method of birth control.
HUMAN CLONING
Common sterilization methods include:
Vasectomy in males ❖ Cloning is the process of extracting the DNA out
of a donor's cell and implanting this genetic code
− the vasa deferentia the tubes which connect, in another cell in order to grow a being with
the testicles to the prostate are cut and closed. identical genes, thus virtually duplicating the
This prevents sperm produced in the testicles donor.
to enter the ejaculated semen which is mostly ❖ The term "clone" refers to the new being that has
produced in the seminal vesicles and prostate. identical genes to the donor.
Tubal ligation in females Arguments in favor of Reproductive Cloning:
− known popularly as ‘having one's tubes ❖ Reproductive cloning can provide genetically
tied’. related children for people who cannot be helped
− The fallopian tubes, which allow the sperm to by other fertility treatments (i.e., who do not
fertilize the ovum and would carry the produce eggs or sperm).
fertilized ovum to the uterus, are closed. This ❖ Reproductive cloning would allow lesbians to
generally involves a general anesthetic and have a child without having to use donor sperm,
laparotomy or laparoscopic approach to cut, and gay men to have a child that does not have
clip or cauterize the fallopian tubes. genes derived from an egg donor (though, of
course, a surrogate would have to carry the
Other procedure that result in sterility: pregnancy).
Hysterectomy in females – the uterus is surgically ❖ Reproductive cloning could allow parents of a
removed, permanently preventing pregnancy and child who has died to seek redress for their loss.
some diseases, such as uterine cancer. ❖ Cloning is a reproductive right and should be
allowed once it is judged to be no less safe than
*Only done to patients with uterine cancer natural reproduction.
Castration in males – the testicles are surgically
removed. This is frequently used for the sterilization

8
Arguments against Reproductive Cloning: technology on its and using them only
own merits. for the purpose of
❖ Reproductive cloning would foster an • Basis: Pro choice research is not
understanding of children, and of people in morally right as it
general, as objects that can be designed and constitutes
manufactured to possess specific characteristics. intentional
❖ Reproductive cloning would diminish the sense destruction of life.
of uniqueness of an individual. It would violate • Basis: Pro Life and
deeply and widely held convictions concerning Religious views
human individuality and freedom and could lead
to an evaluation of clones in comparison with
MUTILATION
non-clones.
❖ Cloned children would unavoidably be raised in ❖ Mutilation or maiming is an act or physical
the shadow of their nuclear donor, in a way that injury that degrades the appearance or function of
would strongly tend to constrain individual the (human)body, usually without causing death.
psychological and social development. ❖ The term is usually used to describe the victims
❖ Reproductive cloning is inherently unsafe. At of accidents, torture, physical assault, or certain
least 95% of mammalian cloning experiments premodern forms of punishment.
have resulted in failures in the form of
miscarriages, stillbirths, and life-threatening Moral Issues on Mutilation
anomalies; some experts believe no clones are ❖ A diseased part is harmful to the whole body.
fully healthy. The technique could not be ❖ Another question pertains to "the predicament of
developed in humans without putting the a person who was ordered by a tyrant to cut off
physical safety of the clones and the women who his own hand.”
bear them at grave risk. ❖ Another case is "the necessity to amputate an
❖ If reproductive cloning is permitted to happen extremity."
and becomes accepted, it is difficult to see how
any other dangerous applications of genetic SUICIDE
engineering technology could be prescribed.
❖ Suicide is the act of intentionally causing one’s
HUMAN CLONING own death.
PRO ANTI ❖ Suicide is often committed out of despair, the
• Genetic cloning are • It is an acceptable cause of which can be attributed to a mental
more openly for norm that life disorder such as depression, bipolar disorder,
therapeutic cloning. begins at schizophrenia, alcoholism, or drug abuse.
• Cloning is a conception and that ❖ Stress factors such as financial difficulties or
reproductive right life cannot be troubles with interpersonal relationships often
and should be created artificially play a significant role.
allowed once it is but from the unity of
judged to be no less a man and female. EUTHANASIA
safe than natural • Hence, once the
reproduction. embryo exists it ❖ Comes from the Greek word, “thanatus” which
• Human society can must be treated as a means "easy or happy death".
accept or reject any person. ❖ Implicit in this etymological meaning is the
proposed • Therefore, outright rejection and avoidance of the opposite:
destroying embryos "a difficult or sorrowful death,” so that the

9
condition of a dying person which is ❖ usually done by means of a positive act either
characterized by intense pain and suffering can by the health care personnel as in direct
be a reason to opt for a willful maneuvering that employment of a lethal measure or by the
which paves the way to an “easy death”. patient himself as in assisted suicide. In
❖ “Easy death” – earlier death that is intentionally assisted suicide, technically, the patient
caused in order to get rid of a “difficult death” administers the fatal means made available
❖ Sacred Congregation for the Doctrine of the Faith by the health care team.
states: 2. Non-Voluntary Euthanasia
❖ indicates the measure of causing the death of
“By Euthanasia is understood an action or
the patient who is unable to express his will
omission which, of itself by intention causes
and make his intentions known as in
death, in order that all suffering may in this
unconscious or comatose state
way be eliminated.”
❖ the decision to end the patient's life is made
TYPES OF EUTHANASIA either by the watchers of the patient, the
health care team, or the society.
Euthanasia by Commission 3. Involuntary Euthanasia
• Active euthanasia ❖ indicates the measure of causing the death of
• Positive act of causing death the patient in defiance of his expressed will
• a measure necessary to end the life of a and/or against his consent.
suffering person is directly used EUTHANASIA
• Example: a lethal dose is injected into the Argument for Argument Against
terminally ill patient to cause immediate Euthanasia Euthanasia
death. • That people should • That these practices
have freedom of can never be
Euthanasia by Omission
choice, including justified for
• Passive euthanasia the right to control religious reasons,
• Negative act of causing death their own body and for example many
life. people believe that
• a measure necessary to sustain the life of a
• Prolonging the life only God has the
suffering person is omitted, withheld or of a person under right to end a human
withdrawn vegetative state is a life.
• Example: food and water are withdrawn to futility and more of • Euthanasia or assist
bring about the earlier death of a terminally a punishment of in a suicide would
ill patient. agony rather than a be a violation of
treatment. fundamental
CATEGORIES OF EUTHANASIA medical ethics. A
1. Voluntary Euthanasia doctor must always
❖ measure of causing the death of the patient at bear in mind the
obligation of
his willful consent for request
preserving human
❖ the consent or request can be verbally
life from
expressed, written in the patient's advance conception.
directive as in a living will or durable power
of attorney, or given by mere gesture in case
of inability to speak and manage oneself.

10
PERSISTENT VEGETATIVE STATE impeded from
taking the final step.
❖ A condition in which a medical patient is
completely unresponsive to psychological
and physical stimuli and displays no sign of * DIGNITAS – a Swiss non-profit members’ society
higher brain function, being kept alive only (in Zürich, Switzerland) which assists suicide to its
by medical intervention. members suffering from terminal illness supported
❖ A vegetative state is called "persistent" if it by qualified Swiss doctor.
lasts for more than four weeks.
Issues:
➢ Withholding and withdrawing of life support
is morally wrong?
➢ Under what circumstance do we consider a
person dead?
➢ How, empirically, does one measure the
irreversible loss of whatever functions have
been determined to be essential for life?
WITHDRAWAL OF LIFE SUPPORT
PRO ANTI
• Keeping someone • Patient who is
alive under suffering PVS, in
vegetative condition the viewpoint of
is not the purpose of medicine, is
medicine or the considered alive.
proper goal for • Being a living
human existence. individual under
• Hence, continuance PVS, life support is
of Life Support is morally obligatory
morally optional and must
and may be maintained in all
withdrawn. PVS.
• The morally • Withdrawal of Life
appropriate Support is
foregoing or "euthanasia by
withholding of Life omission which by
Support in PVS is its very nature and
not abandoning that intention brings
person. Rather, it is about death with the
accepting the fact purpose eliminating
that the person has all pain.
come to the end of
his or her
pilgrimage and
should not be

11

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