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REPUBLIC ACT 8981 • Perform other activities as necessary for

• An Act Modernizing the Professional Regulation effective exercise of powers, functions


Commission, Repealing for the Purpose Presidential • SECTION 6
Decree Numbered Two Hundred and Twenty Three, • Compensation and Other Benefits
Entitled “Creating the Professional Regulation • Chairperson shall receive compensation and
Commission and Prescribing its Powers and Functions” allowances equivalent to that of a Department
and for Other Purposes Secretary
• PD 223 was approved June 22, 1973 • Commissioners shall receive compensation and
• With amendment by PD 657 approved on allowance equivalent to that of an Undersecretary
February 19, 1975 • Entitled to retirement benefits under RA 1568 as
• SECTION 1 amended by RA 3595
• Title • SECTION 7
• PRC Modernization Act of 2000 • Powers, Functions and Responsibilities of the Commission
• SECTION 2 • Administer, implement and enforce regulatory
• Statement of Policy policies; enhancement and maintenance of
• Role of professionals in nation-building professional and occupational standards and
• Promoting sustained development of a reservoir ethics and enforcement of rules and regulations.
of professionals • Perform and all acts, enter contracts, make rules
• Competence determined by honest and and issue orders in the execution of its functions
credible licensure exams and the improvement of services.
• Standards of professional service are • Review, revise and approve policies promulgated
internationally recognized and by Professional Regulatory Boards in the
considered world-class exercise of their powers and functions.
• Brought about by regulatory measures, • SECTION 7
programs and activities that foster • Powers, Functions and Responsibilities of the Commission
professional growth and advancement • Administer and conduct licensure examinations
• SECTION 3 by the various regulatory boards in accordance to
• Professional Regulation Commission the rules and regulations.
• Creation of three-man commission known as the • Determine and fix dates of exam, use of
PRC referred to as the Commission buildings and facilities
• Attached to the Office of the President • Approve the results and its release,
• SECTION 4 appoint supervisors and room watchers,
• Composition publish list of successful examinees,
• 1 full time Chairperson as the head and 2 full provide schools offering courses for
time Commissioners licensure examinations
• Appointed by the President for a term of • Admit successful examinees to the practice of the
7 years without reappointment profession.
• To start at time they assume • Entry of name into registry book and
office database, issue COR and professional
• Appointments to vacancy that occur expiration of ID
term of a Commissioner shall cover only • SECTION 7
unexpired term • Powers, Functions and Responsibilities of the Commission
• Most senior of the Commissioner shall • To have custody of all records of various Boards.
temporarily assume the duties of Chairperson • Exam papers, minutes of deliberation,
until a new appointment is made by the President records of administrative cases and
• SECTION 4 investigations and exam results
• Composition • Determine and fix amount of fees to be charged
• Chairperson and Commissioner shall be at least and collected for examination, registration,
40 years of age registration without examination, professional ID,
• With valid COR / professional license certification, appeal, replacement, accreditation
• With valid professional ID or certificate including surcharges.
of competency issued by the • Fees provided under RA 465 as
Commission or valid professional amended by RA 6511
license issued by any government • Fees as approved by the Office of the
agency President
• Has at least 5 years of executive or • SECTION 7
management experience • Powers, Functions and Responsibilities of the Commission
• One of the Commissioners must be a past • Appoint officials and employees of the
Chairperson / member of a Professional Commission as necessary for effective
Regulatory Board performance of its functions.
• SECTION 5 • Prescribe their duties and fix their
• Exercise of Powers and Functions of the Commission compensation, organize or reorganize
• Chairperson and Commissioners shall sit and act structure of the Commission, create or
as a body abolish positions or change the
• Exercise general administrative, designation of existing positions with
executive and policy making functions approval from Office of President
• Establish and maintain high standard of • Submit and recommend to the President names
admission to the practice of all of licensed / registered professionals for
professions appointment as members of the various
• Ensure and safeguard integrity of all Professional Regulatory Boards.
licensure examinations • From nominees based on the provisions
• Chairperson as the presiding chief executive of EO 496 series 1991
officer • SECTION 7
• Preside over meetings • Powers, Functions and Responsibilities of the Commission
• Implement policies and programs by the • Approve the registration of an authorize the
Commission issuance of a COR / license and professional ID
card with or without examination to a foreigner

Medtech Laws and Ethics || Inosanto Notes | 1


• Requirements for registration in their • Initiate an investigation (upon complaint) any
country is substantially the same with person who practices the profession without
the Philippines and their country allows being authorized by law or without being
Filipinos to practice the profession with registered and licensed or who commits any
same privileges as its citizens in their prohibited acts provided in the regulatory
country laws.
Authorize issuance of COR or special temporary • Prepare annual report of accomplishment on
permit to foreign professionals who desire to practice in the the programs and activities of the
country Commission for submission to Congress and
• Under international agreements, make appropriate recommendations on
consultants, joint ventures or issues and problems affecting the
foreign assisted projects, Commission, Professional Regulatory Board
employees of Philippine or foreign and various professions.
institutions, humanitarian missions • SECTION 7
• SECTION 7 • Powers, Functions and Responsibilities of the
• Powers, Functions and Responsibilities of the Commission
Commission • Perform such other functions and duties as
• Authorize any officer of the Commission to may be necessary to carry out provisions of
administer oaths. this Act.
• Supervise foreign nations who are • SECTION 8
authorized by existing laws to practice their • Regional Offices
profession in the Philippines. • Commission is authorized to create regional
• Ensure terms and conditions for offices as may be necessary to carry out
their practice are complied with their functions.
• Monitor performance of schools in licensure • SECTION 9
exams and publish results in a newspaper of • Powers, Functions and Responsibilities of
national circulation. Professional Regulatory Boards
• SECTION 7 • Regulate the practice of the professions in
• Powers, Functions and Responsibilities of the accordance to provisions of their respective
Commission professional regulatory laws.
• Adopt and institute comprehensive rating • Monitor conditions affecting the practice of
system for universities, colleges and training the profession and adopt measures for
institutions based on passing ratio and enhancement of professions and
overall performance in board exams. maintenance of high standards.
• Exercise administrative supervision over • Conduct inspections to ensure
various professional regulatory boards and compliance
its members. • SECTION 9
• Adopt and promulgate rules and regulations • Powers, Functions and Responsibilities of
as necessary to implement policies. Professional Regulatory Boards
• SECTION 7 • Hear and investigate cases arising from
• Powers, Functions and Responsibilities of the violations of laws.
Commission • Issue subpoenas to alleged
• Implement the program for full violators and/or witnesses to
computerization of all licensure exams given compel attendance in investigations
by various professional regulatory boards and hearings.
including registration of professionals not • Delegate the hearing or investigation of
later than 2003 and other operations. cases filed before them.
• Investigate and decide administrative • Presided by at least 1 member of
matters involving officers and employees the Board assisted by a Legal or
under jurisdiction of the Commission. Hearing Officer of the Commission
• Investigate (upon filing of complaint) any • SECTION 9
member of the Professional Regulatory • Powers, Functions and Responsibilities of
Boards for violations of duties and Professional Regulatory Boards
responsibilities and to revoke or suspend • Conduct (through Legal Officers) summary
CORs and professional IDs. proceedings on minor violations and render
• Recommend their suspension or summary judgement thereon.
removal to the Office of the • Recommend registration without
President examination and issue of COR and
• SECTION 7 professional ID card subject to approval by
• Powers, Functions and Responsibilities of the the Commission.
Commission • Suspend, revoke or reissue, reinstate COR
• Issue summons and subpoenas in or licenses for causes provided by law.
connection with investigation of cases • SECTION 9
against officials and employees of the • Powers, Functions and Responsibilities of
Commission and members of Professional Professional Regulatory Boards
Regulatory Boards. • Prepare, adopt and issue syllabi or table of
• Hold in contempt erring party or person only specifications of the subjects for examination
upon application with a court of competent in consultation with the academe; determine
jurisdiction. and prepare questions for licensure
• Call upon or request any department, office, examinations; score and rate exam papers
agency of government to render assistance and submission of results to the Commission
or to coordinate and cooperate to carry out within 10 days from last day of exam;
and implement professional regulatory determine appropriate passing general
policies. average rating subject to approval by the
• SECTION 7 Commission.
• Powers, Functions and Responsibilities of the • Prepare annual report of accomplishments
Commission for submission to the Commission and make

Medtech Laws and Ethics || Inosanto Notes | 2


recommendations on issues or problems Penalty for accessories
affecting the profession. • Imprisonment from 2 years and 1
• SECTION 10 day to 4 years or a fine from Php
• Compensation of Members of Professional 5,000.00 to Php 19,000.00 or both
Regulatory Boards fine and imprisonment
• Members of the Boards shall receive
compensation equivalent to at least 2 salary • SECTION 16
grades lower than the salary grade of the • Penalties for Violation of Section 7 – Subparagraph 1
Commissioners. by Heads of Government Agencies or Officers of
• Chairperson of Regulatory Board Private Institutions
shall receive monthly compensation • Any violation by heads or officers of
two steps higher than the members agencies on Section 7 subpar. 1
of the Board • Imprisonment of not less than 6
• They are entitled to other months and 1 day to not more than
allowances and benefits provided 6 years or fine of not less than Php
under existing laws 50,000.00 to not more than Php
• SECTION 11 500,000 or both
• Person to Teach Subjects for Licensure Examination • SECTION 17
on all Professions • Implementing Rules and Regulations
• All subjects for licensure exams shall be • The PRC together with various Professional
taught by persons who are holders of valid Regulatory Boards and accredited
COR and professional licenses of the professional organizations, the DBM and
profession and who comply with other CHED shall prepare and promulgate
requirements of CHED necessary rules and regulations needed to
• SECTION 12 implement provisions of this Act
• Assistance of Law Enforcement Agency • Within 90 days after approval of this
• Any law enforcement agency (upon request) Act
shall render assistance in enforcing the • SECTION 18
regulatory law of the profession. • Transitory Provisions
• SECTION 13 • Incumbent Commissioner and 2 incumbent
• Appropriations Associate Commissioners shall serve as
• The amount necessary to carry out initial Chairperson and Commissioners
implementation of this Act shall be charged respectively under the terms for which they
to current year’s (year 2000) appropriations have been appointed
of the PRC • Without need of new appointments
• Sums as may be necessary for • Incumbent Executive Director shall likewise
continued implementation of this serve as Assistant Commissioner without
Act shall be included in the need of new appointment
succeeding General Appropriations • SECTION 19
Act • Separability Clause
• SECTION 14 • If any provision of this Act is declared invalid,
• Authority to Use Income remainder of this Act shall not be affected by
• Commission is authorized to use its income such declaration.
note exceeding Php 45,000,000.00 a year • SECTION 20
for a period of 5 years after effectivity of this • Repealing Clause
Act to implement full computerization of its • All other laws, orders, rules and regulations
operations subject to accounting and inconsistent with the provisions of this Act
auditing requirements. are hereby repealed or amended
• SECTION 15 accordingly.
• Penalties for Manipulation and Other Corrupt • SECTION 21
Practices in the Conduct of Professional • Effectivity
Examinations • This Act shall take effect after 15 days
• Manipulation of exam results, makes know following publication in the Official Gazette or
exam questions prior to conduct of exams or in 2 newspapers of general circulation
tampers with the grades in licensure exams • Approved December 5, 2000
• Imprisonment of not less than 6 • REFERENCES
years and 1 day to 12 years 1. Moraleta, N. 2015. Manila, Philippines.
• Fine of at least Php 50,000.00 to 2. Suba, S.C. Milanez, G.D.J. 2017. C&E Publishing,
Php 100,000.00 Inc. Quezon, City, Philippines.
• Or both fine and imprisonment
• If offender is an officer or employee of the
Commission or member of the regulatory
REPUBLIC ACT 9288
board • Medical Technology laws
• Removal from office and penalty of • PRIOR LAWS
perpetual absolute disqualification • Administrative Order 1-A series of 2000
from public office along with • Policies on the Nationwide Implementation of
penalties prescribed in preceding Newborn Screening
section of this Act • January 3, 2000
• SECTION 15 • Administrative Order 121 series of 2003
• Penalties for Manipulation and Other Corrupt • Strengthening Implementation of the
Practices in the Conduct of Professional National Newborn Screening System
Examinations • December 9, 2003
• Penalty for accomplices • REPUBLIC ACT 9288
• Imprisonment from 4 years and 1 • An Act Promulgating a Comprehensive Policy and a
day to 6 years or a fine from Php National System for Ensuring Newborn Screening
20,000.00 to Php 49,000.00 or both • SECTION 1
fine and imprisonment • Short Title

Medtech Laws and Ethics || Inosanto Notes | 3


• Newborn Screening Act of 2004 • SECTION 6
• SECTION 2 • Performance of Newborn Screening
• Declaration of Policy • Performed after 24 hours of life but not later
• Protect and promote health of the people, than 3 days from complete delivery of
including rights of children newborn
• Survival and full and healthy • If newborn is in ICU, exempted from 3 day
development as normal individuals requirement but must be tested by 7 days of
• Institutionalize a newborn screening system age
• Ensure that every baby born in the • Responsibility of both parent/s and
Philippines is offered the opportunity to practitioner or other person delivering the
undergo newborn screening newborn to ensure newborn screening is
• Spared from heritable conditions performed
that can lead to mental retardation • SECTION 7
and death • Refusal to be tested
• SECTION 3 • Parent or legal guardian may refuse testing
• Objectives on grounds of religious belief
• Ensure that every newborn has access to • Acknowledge in writing their
newborn screening for certain heritable understanding that refusal places
conditions their newborn at risk for
• Establish and integrate a sustainable undiagnosed heritable conditions
newborn screening system • SECTION 8
• Ensure that all health practitioners are aware • Continuing Education, Re-education and Training
of the advantages of newborn screening and Health Personnel
of their responsibilities in offering newborn • DOH with assistance of the NIH and other
screening agencies
• Ensure that parents recognize their • Conduct continuing information,
responsibility in promoting their child’s right education, re-education and training
to health and full development programs for health personnel
• CURRENTLY SCREENED DISORDERS • Disseminate information materials
1. Congenital hypothyroidism (CH) annually to all health personnel
2. Congenital adrenal hyperplasia (CAH) involved
3. Phenylketonuria (PKU) • SECTION 9
4. Glucose-6-phosphate dehydrogenase deficiency • Licensing and Accreditation
(G6PD) • DOH and PHIC shall require health
5. Galactosemia (GAL) institutions to provide newborn screening
6. Maple syrup urine disease (MSUD) services as condition for licensure or
• CONGENITAL HYPOTHYROIDISM accreditation
• Inadequate thyroid hormone production on newborns. • SECTION 10
• Defect in the gland, inborn error of thyroid • Lead Agency
metabolism or iodine deficiency • DOH shall be lead agency in implementing
• CONGENITAL ADRENAL HYPERPLASIA this Act
• Autosomal recessive disorders causing deficiency of • Establish Advisory Committee on
enzymes Newborn Screening
• Deficiency of 21-hydroxylase • Develop implementing rules and
• Less production of cortisol and/or regulations
aldosterone • Coordinate with DILG for
• PHENYLKETONURIA implementation of newborn
• Increases levels of phenylalanine in the blood screening program
• Increased levels can cause intellectual • Coordinate with NIH Newborn
disability and other health problems Screening Reference Center for
• G6PD DEFICIENCY accreditation of Newborn Screening
• Inadequate amount of glucose-6-phosphate Centers and preparation of testing
dehydrogenase in the blood protocols and quality assurance
• RBCs prone to oxidative damage causing programs
hemolysis • SECTION 11
• GALACTOSEMIA • Advisory Committee on Newborn Screening
• Inability to break down galactose sugar • Secretary of Health as Chairman
• Galactose builds up in the blood causing health • Executive Director of NIH as Vice
issues Chairperson
• MAPLE SYRUP URINE DISEASE • Executive Director of the Council for Welfare
• Body is unable to break down certain amino acids of Children
• Leucine, isoleucine, valine • Director of the Newborn Screening
• Buildup of substances in blood Reference Center
• Urine has characteristic maple syrup odor • 3 representatives appointed by Secretary of
• SECTION 4 Health who shall be a pediatrician,
• Definition of Terms obstetrician, endocrinologist, family
• Comprehensive Newborn Screening System physician, nurse or midwife from public or
• Newborn private sector
• Newborn Screening • Term of 3 years subject to
• Newborn Screening Center reappointment for additional 3 years
• Newborn Screening Reference Center for each extension
• SECTION 5 • Committee shall meet at least twice a year
• Obligation to Inform • CHAPTER 12
• Inform parents or legal guardian of newborn • Establishment and Accreditation of Newborn
of availability, nature and benefits of Screening Centers
newborn screening • DOH shall ensure strategically located to be
• Main responsibility of DOH accessible to the public

Medtech Laws and Ethics || Inosanto Notes | 4


• No newborn screening center shall be • Definition of Terms
allowed to operate unless duly accredited by • Accreditation
the DOH based on standards set by the • AIPO/APO
Committee • ASEAN Qualifications Reference Framework
• CHAPTER 13 (AQRF)
• Establishment of a Newborn Screening Reference • ASEAN Mutual Recognition Arrangement
Center (AMRA)
• NIH shall establish a Newborn Screening • Continuing Professional Development (CPD)
Reference Center • CPD Council
• Responsible for national testing • CPD Program
database and case registries, • CPD Provider
training, technical assistance and • SECTION 4
continuing education • Strengthening the CPD Program
• SECTION 14 • Enhance and upgrade competency and
• Quality Assurance qualifications of professionals
• NIH Newborn Screening Reference Center • Ensure international alignment of
shall be responsible for drafting and ensuring competencies and qualifications of
good laboratory practice standards for professionals
newborn screening centers • Ensure development of quality assured
• SECTION 15 mechanisms for validation, accreditation and
• Database recognition of learning outcomes
• All newborn screening centers shall • Ensure maintenance of core competencies
coordinate with the NIH Newborn Screening and development of advanced and new
Reference Center for consolidation of patient competencies to respond to labor market
database needs
• Maintain a national database of patients • Recognize and ensure contributions of
tested and a registry for each condition professionals in uplifting general welfare,
• SECTION 16 economic growth and development of the
• Newborn Screening Fees nation
• PHIC shall include newborn screening in its • SECTION 5
benefits package • Nature of CPD Programs
• Screening fee shall be applied to testing • Activities that range from structured to
costs, education, sample transport, follow-up nonstructured activities
and reasonable overhead expenses • Have learning processes and
• Distribution of fees outcomes
• At least 4% each to the following • Formal, nonformal, informal, self-
• DOH Centers for Health directed, online learning activities,
Development professional work experience
• Newborn Screening • SECTION 6
Centers • Powers, Functions and Responsibilities of the PRC
• NIH Newborn Screening and the Professional Regulatory Boards (PRBs)
Center • Organize CPD Councils for each regulated
• FINAL PROVISIONS profession and promulgate guidelines
• Section 17 – Repealing Clause • Review existing and new CPD Programs for
• Section 18 – Separability all regulated professions
• Section 19 – Effectivity • Formulate, issue and promulgate guidelines
• This Act shall take effect 15 days after its and procedures for the implementation of the
publication in at least 2 newspapers CPD Programs
• Approved by the President April 7, 2004 • Coordinate with the academe, government
• REFERENCES agencies and stakeholders in the
1. Moraleta, N. 2015. Manila, Philippines. implementation of CPD Programs
2. Suba, S.C. Milanez, G.D.J. 2017. C&E Publishing, • Coordinate with government agencies in the
Inc. Quezon, City, Philippines. development of mechanisms in the grant and
transfer of credit units earned from all
REPUBLIC ACT 10912 learning activities
• SECTION 7
• An Act Mandating and Strengthening the Continuing
• CPD Council
Professional Development Program for All Regulated
• Creation of CPD Council in each of the
Professions, Creating the Continuing Professional
regulated professions
Development Council, and Appropriating Funds
• Under supervision of concerned
Thereof, and for Other Related Purposes
PRB
• SECTION 1
• CPD Council composed of 1 chairperson
• Title
and 2 members
• Continuing Professional Development Act of
• Chairperson shall be the member of
2016
the PRB concerned
• SECTION 2
• 1st member president or officer of
• Declaration of Policy
AIPO/APO
• Promote and upgrade the practice of
• 2nd member president or officer of
professions
national organization of deans and
• Continuously improve the competence of
department chairpersons of schools
professionals
and universities offering the course
• In accordance with international
requiring licensure examination
standards
• Term of office
• Contribution in uplifting the general welfare,
• Chairperson coterminous with
economic growth and development of the
incumbency in the PRB
nation
• Members shall have office of 2
• SECTION 3
years

Medtech Laws and Ethics || Inosanto Notes | 5


• SECTION 8 • PRC and PRBs shall promulgate the
• Powers, Functions and Responsibilities of the CPD implementing rules and regulations (IRR)
Council within 6 months from effectivity of this Act
• Ensure appropriate provision of CPD • In consultation with AIPO/APO and
Programs for their respective profession other stakeholders
• Evaluate and act on applications for • PRBs may prescribe its own requirements or
accreditation of CPD Providers and their procedure as may be pertinent and
CPD Programs applicable to the specific profession
• Monitor and evaluate implementation of CPD • Provided, does not contravene any
Programs of the provisions of this Act or its
• Assess and/or upgrade the criteria for IRR
accreditation of CPD Providers and CPD • SECTION 16
Programs • Fraud Relating to CPD
• SECTION 8 • Fraudulent acts relating to implementation
• Powers, Functions and Responsibilities of the CPD and enforcement of this Act
Council • Punishable under provisions of the
• Develop mechanisms for validation, Revised Penal Code, New Civil
accreditation and recognition of self-directed Code and other applicable laws
learning, prior/informal learning, online • Professional adjudged guilty of fraudulent
learning and other learning processes acts related to CPD
• Conduct research and benchmarking for • Suspension or revocation of PRC
international alignment COR and/or Certificate of
• Issue operational guidelines with approval of Specialization
PRC and PRB • Government official or employee guilty of
• Perform such other functions related to fraudulent acts
implementation of CPD • Administrative penalties to be
• SECTION 9 imposed under anti-graft laws, the
• Secretariat Administrative Code and the Code
• CPC Council Secretariat is created at the of Conduct of Public Officials and
PRC Central and Regional Offices Employees
• Technical administrative and • SECTION 17
operational support to CPD • Separability Clause
Councils and the PRBs • Any part or provision of this Act is declared
• Headed by an Executive Director invalid, the other provisions will not be
appointed by PRC affected and shall remain in force and effect
• SECTION 10 • SECTION 18
• CPD as Mandatory Requirement in the Renewal of • Repealing Clause
Professional License and Accreditation System for the • All laws, decrees, EOs inconsistent with the
Practice of Professions provisions of this Act are repealed or
• CPD is required for renewal of Professional modified accordingly
Identification Cards (PIC) of all registered • SECTION 19
and licensed professionals under PRC • Effectivity
• SECTION 11 • This Act shall take effect 15 days following
• Recognition of Credit Units complete publication in the Official Gazette
• All duly validated and recognized CPD credit or in 2 newspapers of general circulation
units earned shall be accumulated and • Approved by Congress May 23, 2016
transferred in accordance with Pathways and • Lapsed into law
Equivalencies of the Philippine Qualifications • July 21, 2016
Framework • Was not signed by Former President
• SECTION 12 Benigno S. Aquino III
• Career Progression and Specialization • CPD ACTIVITIES
• PRC and PRBs shall formulate and • Originally, Medical Technologists are required 45
implement a Career Progression and CPD units for renewal of Professional ID
Specialization Program for every profession • Currently, required CPD units has been adjusted by
as part of the CPD the updated IRR
• In consultation with AIPO/APO, • To provide professionals adequate time to
Civil Service Commission (CSC), prepare given this newly implemented law
government agencies, stakeholders • CPD ACTIVITIES
• SECTION 13 • CPD ACTIVITIES
• Role of Concerned Government Agencies and Private • CPD ACTIVITIES
Sector • CPD ACTIVITIES
• All concerned government agencies and • CPD ACTIVITIES
private firms employing professionals shall • REFERENCES
include CPD as part of their human resource 1. Moraleta, N. 2015. Manila, Philippines.
development plan and program 2. Suba, S.C. Milanez, G.D.J. 2017. C&E Publishing,
• SECTION 14 Inc. Quezon, City, Philippines.
• Funding
• Funding included in the General
Appropriations Act under the PRC
• Funding to be used for regular operations of BASIC INFORMATION ABOUT NEWBORN
the CPD Councils, including monitoring of SCREENING
the conduct of CPD Programs PRESENTED BY:
• PRC shall review and approve proposed JC JOHN T. JAMILI, RMT, MSMT-CAR
budget by each CPD Council From:
• SECTION 15 NSRC
• Implementing Rules and Regulations Newborn Screening Reference Center
N.I.H., U.P. Manila

Medtech Laws and Ethics || Inosanto Notes | 6


 but the laboratory testing methods applied are
different.
What are the additional disorders tested by expanded
newborn screening?
 Aside from the six conditions in the previous panel:
 Congenital Hypothyroidism
 Congenital Adrenal Hyperplasia
 Galactosemia
 Phenylketonuria
 Maple Syrup Urine Disease
 Glucose-6-Phosphate Dehydrogenase Deficiency
 The expanded newborn screening will screen for
additional disorders falling under various groups of
conditions namely:
 Hemoglobinopathies
Unit 304 New Gold Bond Building  Disorders of amino acid and organic acid metabolism
1579 F. T. Benitez St., Malate, Manila  Disorders of fatty acid oxidation
 Disorders of carbohydrate metabolism
 Disorders of biotin metabolism
 Cystic fibrosis
How much is the fee for newborn screening?
 Expanded newborn screening will be offered to you
as an option in all newborn screening facilities.
 The first option is screening for the six disorders at
₱550, which is included in the newborn care package
for PhilHealth members.
 The second option is screening for the full
complement of 28 disorders at ₱1,500.
Is expanded screening covered by PhilHealth?
 Currently, only P550 is covered by PhilHealth.
 If you are a PhilHealth member, and opt to have your
baby undergo expanded newborn screening:
 you will pay the remaining cost which is P950.
Where is newborn screening available?
 Newborn screening is available in:
o Hospitals
What is newborn screening? o Lying-ins
 Newborn Screening (NBS) is a simple procedure to o Rural Health Unit
find out if your baby has a congenital metabolic o Health Centers
disorder that may lead to mental retardation or even o some private clinics.
death if left untreated. o If babies are delivered at home, babies may
Why is it important to have newborn screening? be brought to the nearest institution offering
 Most babies with metabolic disorders look "normal" at newborn screening.
birth. When are newborn screening results available?
 By doing NBS, metabolic disorders may be detected  Results can be claimed from the health facility where
even before clinical signs and symptoms are present. NBS was availed.
 And as a result of this, treatment can be given early to  Normal NBS Results are available by 7 - 14 working
prevent consequences of untreated conditions. days from the time samples are received at the NSC.
When is newborn screening done?  Positive NBS results are relayed to the parents
 Newborn screening is ideally done immediately after immediately by the health facility.
24 hours from birth.  Please ensure that the address and phone number
How is newborn screening done? you will provide to the health facility are correct.
 A few drops of blood are taken from the baby's heel,  A NEGATIVE SCREEN MEANS THAT THE NBS
blotted on a special absorbent filter card and then RESULT IS NORMAL.
sent to Newborn Screening Center (NSC).
Who will collect the sample for newborn screening ? A positive screen means that the newborn must be
 The blood sample for NBS may be collected by any of brought back to his/her health practitioner for further
the following: testing.
o Physician What should be done when a baby is tested a positive
o Nurse NBS result?
o Medical technologist  Babies with positive results must be referred at once
o Trained midwife to a specialist for confirmatory testing and further
What is expanded newborn screening? management.
 The expanded newborn screening program will  Should there be no specialist in the area, the NBS
increase the screening panel of disorders from six (6) secretariat office will assist its attending physician.
to twenty-eight (28).
 This will provide opportunities to significantly improve Why screen your baby?
the quality of life of affected newborns through  Standard 6-Test
facilitating early diagnosis and early treatment.
What is the difference between newborn screening and  Expanded Newborn Screening
expanded newborn screening?
 The difference is the number of disorders each of
them can detect.
 Both tests are performed by collecting a few drops of
blood through the heel-prick method,

Medtech Laws and Ethics || Inosanto Notes | 7


• 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.
• SEC. 3. Objectives. - The objectives of the National
Newborn Screening System are:
RA 9288: NEWBORN SCREENING ACT • 1) To ensure that every newborn has access to
newborn screening for certain heritable conditions
Presented by:
that can result in mental retardation, serious health
JC John T. Jamili, RMT, MSMT-CAR
complications or death if left undetected and
• Republic of the Philippines
untreated;
Congress of the Philippines
• SEC. 3. Objectives. - The objectives of the National
Metro Manila
Newborn Screening System are:
Twelfth Congress
• 2) To establish and integrate a sustainable newborn
Third Regular Session
screening system within the public health delivery
• Begun and held in Metro Manila, on Monday, the
system;
twenty-eight day of July, two thousand three.
• SEC. 3. Objectives. - The objectives of the National
• Republic Act No. 9288
Newborn Screening System are:
April 07, 2004
• 3) To ensure that all health practitioners are aware of
• AN ACT PROMULGATING A COMPREHENSIVE
the advantages of newborn screening and of their
POLICY AND A NATIONAL SYSTEM FOR
respective responsibilities in offering newborns the
ENSURING NEWBORN SCREENING
opportunity to undergo newborn screening; and
• Be it enacted by the Senate and House of
• SEC. 3. Objectives. - The objectives of the National
Representatives of the Philippines in Congress
Newborn Screening System are:
assembled:
• 4) To ensure that parents recognize their
• ARTICLE 1
responsibility in promoting their child's right to health
GENERAL PROVISIONS
and full development, within the context of
SECTION 1. Short Title. - This Act shall be known as the
responsible parenthood, by protecting their child from
"Newborn Screening Act of 2004."
preventable causes of disability and death through
• SEC. 2. Declaration of Policy.
newborn screening.
• It is the policy of the State to protect and promote the
• ARTICLE 2
right to health of the people, including the rights of
DEFINITION OF TERMS
children to survival and full and healthy development
• SEC. 4. Definitions. - Under this Act, the following
as normal individuals.
terms shall have the meanings respectively given to
• In pursuit of such policy, the State shall institutionalize
them below:
a national newborn screening system that is
1) Comprehensive Newborn Screening System
comprehensive, integrative and sustainable, and will
means a newborn screening system that includes,
facilitate collaboration among government and non-
but is not limited to, education of relevant
government agencies at the national and local levels,
stakeholders;
the private sector, families and communities,
collection and biochemical screening of blood
professional health organizations, academic
samples taken from newborns;
institutions, and non-governmental organizations.
tracking and confirmatory testing to ensure the
• SEC. 2. Declaration of Policy.
accuracy of screening results;
The National Newborn Screening System shall ensure that
clinical evaluation and biochemical/medical
confirmation of test results;
drugs and medical/surgical management and dietary
supplementation to address the heritable conditions;
and evaluation activities to assess long term outcome,
patient compliance and quality assurance.
2) Follow-up
means the monitoring of a newborn with a heritable
condition
for the purpose of ensuring that the newborn patient
complies fully with the medicine of dietary
prescriptions.
3) Health institutions
mean hospitals, health infirmaries, health centers,
lying-in centers or puericulture centers with obstetrical
and pediatric services, whether public or private.
4) Healthcare practitioner
means physicians, nurses, midwives, nursing aides
and traditional birth attendants.
5) Heritable condition
means any condition that can result in mental
retardation, physical deformity or death if left
undetected and untreated and
which is usually inherited from the genes of either or
both biological parents of the newborn.
6) NIH
means the National Institute of Health
7) Newborn
means a child from the time of complete delivery to 30
days old.
8) Newborn Screening
means the process of collecting a few drops of blood
every baby born in the Philippines: from the newborn onto an appropriate collection card

Medtech Laws and Ethics || Inosanto Notes | 8


and performing biochemical testing for determining if (i) conduct continuing information, education, re-
the newborn has a heritable condition. education and training programs for health personnel
9) Newborn Screening Center on the rationale, benefits, procedures of newborn
means a facility equipped with a newborn screening screening; and
laboratory that complies with the standards (ii) disseminate information materials on newborn
established by the NIH and provides all required screening at least annually to all health personnel
laboratory tests and recall/follow-up programs for involved in material and pediatric care.
newborns with heritable conditions. • SEC. 9. Licensing and Accreditation.
10) Newborn Screening Reference Center The DOH and the Philippine Health Insurance Corporation
means the central facility at the NIH (PHIC)
that defines testing and follow-up protocols, maintains • shall require health institutions to provide newborn
an external laboratory proficiency testing program, screening services as a condition for licensure or
oversees the national testing database and case accreditation.
registries, assists in training activities in all aspects of • ARTICLE 4
the program, oversees content of educational IMPLEMENTATION
materials • SEC. 10. Lead Agency. - The DOH shall be the lead
and acts as the Secretariat of the Advisory Committee agency in implementing this Act.
on Newborn Screening. • For purposes of achieving the objectives of this Act,
11) Parent education the DOH shall:
means the various means of providing parents or 1) Establish the Advisory Committee on Newborn Screening:
legal guardians information about newborn screening. 2) Develop the implementing rules and regulations for the
12) Recall immediate implementation of a nationwide newborn screening
means a procedure for locating a newborn with a program
possible heritable condition - within one hundred eight (180) days from the
for purposes of providing the newborn with enactment of this Act;
appropriate laboratory to confirm the diagnosis and, 3) Coordinate with the Department of the Interior and Local
as appropriate, provide treatment. Government (DILG)
13) Treatment - for implementation of the newborn screening
means the provision of prompt, appropriate and program;
adequate medicine, medical, and surgical 4) Coordinate with the NIH Newborn Screening Reference
management or dietary prescription to a newborn Center
for purposes of treating or mitigating the adverse - for the accreditation of Newborn Screening Centers
health consequences of the heritable condition. and preparation of defined testing protocols and
• ARTICLE 3 quality assurance programs.
NEWBORN SCREENING • SEC. 11. Advisory Committee on Newborn
SEC. 5. Obligation to Inform. Screening.
- Any health practitioner who delivers, or assists in the To ensure sustained inter-agency collaboration:
delivery, of a newborn in the Philippines - the Advisory Committee on Newborn Screening is
- shall, prior to delivery, inform the parents or legal hereby created and made an integral part of the
guardian of the newborn of the availability, nature and Office of the Secretary of the DOH.
benefits of newborn screening. • The Committee shall:
- Appropriate notification and education regarding this • review annually and recommend conditions to be
obligation shall be the responsibility of the included in the newborn screening panel of disorders;
Department of Health (DOH). • review and recommend the newborn screening fee to
• SEC. 6. Performance of Newborn Screening. be charged by Newborn Screening Centers;
Newborn screening shall be performed: • review the report of the Newborn Screening
- after twenty-four (24) hours of life but not later than Reference Center on the quality assurance of the
three (3) days from complete delivery of the newborn. National Screening Centers and
A newborn that must be placed in intensive care in order to • recommend corrective measures as deemed
ensure survival may be exempted from the 3-day requirement necessary.
but must be tested by seven (7) days of age. • The Committee shall be composed of eight (8)
• It shall be the joint responsibility of the parent(s) and members:
the practitioner or other person delivering the The Secretary of Health who shall act as Chairman.
newborn to ensure that newborn screening is The other members of the Committee shall be as follows:
performed. (i) the Executive Director of the NIH, who shall act as
An appropriate informational brochure for parents to assist in Vice Chairperson;
fulfilling this responsibility shall be made available by the (ii) an Undersecretary of the DILG;
Department of Health (iii) the Executive Director of the Council for the Welfare
- and shall be distributed to all health institutions of Children
- and made available to any health practitioner (iv) the Director of the Newborn Screening Reference
requesting it for appropriate distribution. Center; and
• SEC. 7. Refusal to be Tested. (v) three (3) representatives appointed by the Secretary
A parent or legal guardian may refuse testing on the grounds of Health who shall be a:
of religious beliefs, - pediatrician, obstetrician, endocrinologist, family
- but shall acknowledge in writing their understanding physician, nurse or midwife, from either the public or
that refusal for testing places their newborn at risk for private sector.
undiagnosed heritable conditions. The three (3) representatives shall be appointed for a term of:
A copy of this refusal documentation shall be made part of the - three (3) years, subject to their being reappointed for
newborn's medical record additional three (3) years period for each extension.
- and refusal shall be indicated in the national newborn The Committee shall meet:
screening database. - at least twice a year.
• SEC. 8. Continuing Education, Re-education and The NIH shall serve as the Secretariat of the Committee.
Training Health Personnel. • SEC. 12. Establishment and Accreditation of
The DOH, with the assistance of the NIH and other Newborn Screening Centers.
government agencies, professional societies and non- • The DOH shall ensure that Newborn Screening
government organizations, shall: Centers are strategically located in order to be
accessible to the relevant public and provide services

Medtech Laws and Ethics || Inosanto Notes | 9


that comply with the standards approved by the • To ensure sustainability of the National System for
Committee upon the recommendation of the NIH. Newborn Screening:
At least four percent (4%) to the Newborn Screening Centers
• No Newborn Screening Center shall be allowed to for:
operate unless it has been duly accredited by the - human resource development and
DOH based on the standards set forth by the - equipment maintenance and upgrading;
Committee. • To ensure sustainability of the National System for
• At a minimum, every Newborn Screening Center Newborn Screening:
shall: At least four percent (4%) to the NIH Newborn Screening
(i) have a certified laboratory performing all tests Reference Center for:
included in the newborn screening program, - overall supervision, training and continuing education,
(ii) have a recall/follow up programs for infants found - maintenance of national database,
positive for any and all of the heritable conditions; - quality assurance program and
(iii) be supervised and staffed by trained personnel who - monitoring of the national program;
have been duly qualified by the NIH; and And the balance for the operational and other expenses of the
(iv) submit to periodic announced or unannounced Newborn Screening Center.
inspections by the Reference Center in order to • ARTICLE 5
evaluate and ensure quality Newborn Screening FINAL PROVISIONS
Center performance. SEC. 17. Repealing Clause.
• SEC. 13. Establishment of a Newborn Screening - All general and special laws, decrees, executive orders,
Reference Center. proclamations and administrative regulations, or any parts
The NIH shall establish a Newborn Screening Reference thereof, which are inconsistent with this Act are hereby
Center, repealed or modified accordingly.
• which shall be responsible for the national testing • SEC. 18. Separability.
database If, for any reason or reasons, any party of provisions of this Act
• and case registries, training, technical assistance and shall be declared or held to be unconstitutional or invalid:
continuing education for laboratory staff in all - other provision or provisions hereof which are not affected
Newborn Screening Centers. thereby shall continue to be in full force and effect.
• SEC. 14. Quality Assurance. • SEC. 19. Effectivity.
The NIH Newborn Screening Reference Center shall be This Act shall take effect:
responsible for: - drafting and ensuring good laboratory - fifteen (15) days after its publication in at least two (2)
practice standards for newborn screening centers, newspapers of general circulation.
- including establishing an external laboratory • Approved,
proficiency testing and certification program. FRANKLIN DRILON
It shall also act as the principal repository of technical President of the Senate
information relating to newborn screening standards and JOSE DE VENECIA JR.
practices, Speaker of the House of Representatives
- and shall provide technical assistance to newborn • This Act which is consolidation of Senate No. 2707
screening centers needing such assistance. and House Bill No. 6625 was finally passed by the
• SEC. 15. Database. Senate and the House of Representatives on
- All Newborn Screening Centers shall coordinate with the NIH February 2, 2004 and February 5, 2004, respectively
Newborn Screening Reference Center for consolidation of OSCAR G. YABES
patient databases. Secretary of Senate
The NIH Newborn Screening Reference Center shall maintain ROBERTO P. NAZARENO
a national database of patients tested and a registry for each Secretary General
condition. House of Represenatives
- It shall submit reports annually to the Committee and Approved: April 07, 2004
to the DOH on the status of and relevant health GLORIA MACAPAGAL-ARROYO
information derived from the database. President of the Philippines
A plan for long-term outcome evaluation of newborn screening
utilizing the cases registries: AO 2008-0026-A
- shall be developed within one (1) year of passage of Addendum to the Rules and Regulations Implementing
this Act by the NIH Newborn Screening Reference Republic Act No. 9288, Otherwise Known as the "New Born
Center in consultation with the Advisory Committee Screening Act of 2004"
on Newborn Screening. Presented by:
Implementation of this plan shall become a responsibility of the JC John T. Jamili, RMT, MSMT-CAR
Advisory Committee on Newborn Screening. *see image attached at back*
• SEC. 16. Newborn Screening Fees.
The PHIC shall include cost of newborn screening in its SUMMARY OF:
benefits package.
REPUBLIC ACT 8504
The newborn screening fee shall be applied to, among others:
Philippine AIDS Prevention and Control Act of 1998
- testing costs
Presented by:
- education
JC John T. Jamili, RMT, MSMT-CAR
- sample transport
 ”AN ACT PROMULGATING POLICIESAND
- follow-up and
PRESCRIBING MEASURES FOR THE
- reasonable overhead expenses.
PREVENTIONAND CONTROL OF HIV/AIDS IN THE
• To ensure sustainability of the National System for
PHILIPPINES,INSTITUTING A NATIONWIDE
Newborn Screening:
HIV/AIDS INFORMATION AND EDUCATIONAL
The newborn screening fee shall be divided and set aside for
PROGRAM, ESTABLISHING A COMPREHENSIVE
the following purposes:
HIV/AIDS MONITORING SYSTEM,
At least four percent (4%) to the DOH's Centers for Health
STRENGTHENINGTHE PHILIPPINENATIONAL
Development or its future equivalent to be spent solely for
AIDS COUNCIL, AND FOROTHERPURPOSES”
- follow-up services,
 What is RA 8504 all about?
- education
 Participation of affected individuals in propagating
- and other activities directly related to the provision of
vital information and educational messages about
newborn screening services;
HIV/AIDS

Medtech Laws and Ethics || Inosanto Notes | 10


 Positively address and seek to eradicate conditions  the presence of HIV infection as documented
that aggravate the spread of HIV infection by the presence of HIV or HIV antibodies in
 Safety and universal precautions in practices and the sample being tested.
procedures that carry risk of HIV transmission  "HIV-negative"
 What is RA 8504 all about?  denotes the absence of HIV or HIV
 Full protection of the human rights and civil liberties of antibodies upon HIV testing.
every person suspected or known to be infected with  "HIV Testing"
HIV and AIDS  any laboratory procedure done on an
 Public awareness through comprehensive nationwide individual to determine the presence or
educational and information campaign absence of HIV infection.
 Background  "HIV Transmission“
 Was approved on: February 13, 1998  the transfer of HIV from one infected person
 Approved by: Former President Fidel V. Ramos to an uninfected individual, most commonly
 Mandated by: The Philippine National AIDS Council through sexual intercourse, blood
(PNAC) transfusion, sharing of intravenous needles
 Created on: December 3,1992 , by Executive Order and during pregnancy.
No.39  "High-Risk Behavior“
PNAC is reconstituted by Republic Act 8504 as the central  a person's frequent involvement in certain
advisory, planning and policy making body on the prevention activities which increase the risk of
and control of HIV and AIDS in the country. transmitting or acquiring HIV.
 Functions of the Philippine National AIDS Council  "Informed Consent“
(PNAC):  the voluntary agreement of a person to
 Secure recommendations, ensure coverage in undergo or be subjected to a procedure
information and education, monitoring, guidelines in based on full information, whether such
medical and other practices and procedures, health permission is written, conveyed verbally, or
and support services, testing and counseling, expressed indirectly.
protection of rights, observance of confidentiality  "Medical Confidentiality”
 Monitor the implementation of the rules and  the relationship of trust and confidence
regulation, issue or cause issuance of orders, or created or existing between a patient or a
make recommendations person with HIV and his attending physician
 Functions of the Philippine National AIDS Council and all other health personnel involved in
(PNAC): any counseling, testing or professional care
 Develop and monitor comprehensive, long-term  "Person with HIV"
program  an individual whose HIV test indicates,
 Coordinate and strengthen working relationships of directly or indirectly, that he/she is infected
government and non-government agencies with HIV.
 Coordinate and cooperate with foreign and  "Pre-Test Counseling“
international organizations  process of providing an individual
 Evaluate adequacy and recommend on utilization of information on the biomedical aspects of
resources HIV/AIDS and emotional support to any
 Definition of terms psychological implications of undergoing HIV
 "Acquired Immune Deficiency Syndrome (AIDS)" testing and the test result itself before he/she
 a condition characterized by a combination is subjected to the test.
of signs and symptoms, caused by HIV  "Post-Test Counseling“
contracted from another person and which  process of providing risk-reduction
attacks and weakens the body's immune information and emotional support to a
system, making the afflicted individual person who submitted to HIV testing at the
susceptible to other life-threatening time that the test result is released.
infections.  "Prophylactic“
 "Anonymous Testing"  any agent or device used to prevent the
 HIV testing procedure whereby the individual transmission of a disease.
being tested does not reveal his/her true  "Voluntary HIV Testing"
identity and uses number or symbol to  HIV testing done on an individual who, after
substitute for the name. having undergone pre-test counseling,
 "Compulsory HIV Testing" willingly submits himself/herself to such test.
 HIV testing imposed upon a person attended  "Sexually Transmitted Diseases"
or characterized by the lack of or vitiated  any disease that may be acquired
consent, use of physical force, intimidation or or passed on through sexual
any form of compulsion. contact.
 "Contact tracing"  "Window Period“
 refers to the method of finding and  the period of time, usually lasting from two
counseling the sexual partner(s) of a person weeks to six (6) months during which an
who has been diagnosed as having STD. infected individual will test "negative" upon
 "Human Immunodeficiency Virus (HIV)" HIV testing but can actually transmit the
 refers to the virus which causes AIDS. infection.
 "HIV/AIDS Monitoring"  Article 1: EDUCATION AND INFORMATION
 documentation and analysis of the number of  The Government must promote education and
HIV/AIDS infections and the pattern of its information campaigns.
spread.  Schools and non-formal education programs
 "HIV/AIDS Prevention and Control" must include HIV education.
 measures aimed at protecting non-infected  The DOH must conduct public health
from contracting HIV and minimizing the education campaigns.
impact of the condition of persons living with  The government must provide education for
HIV. Filipinos going abroad.
 " HIV-positive"  LGUs must develop local HIV prevention and
education efforts.

Medtech Laws and Ethics || Inosanto Notes | 11


 It is against the law to give false or  Medical confidentiality shall not be considered
intentionally misleading information on breached in the following cases: (continued)
HIV/AIDS. When informing other health workers directly involved or about
 Article 2: SAFE PRACTICES AND PROCEDURES to be involved in the treatment or care of a person with
 The Government will develop and promote safe HIV/AIDS:
medical practices  Provided, that such treatment or care carry the risk of
 All blood, organs, and tissue for donation will HIV transmission:
be tested. If it tests positive, it will be  Provided, further, that such workers shall be obliged
disposed of safely, and not used. to maintain the shared medical confidentiality;
 The DOH will provide guidelines on safe  Medical confidentiality shall not be considered
surgery and medical procedures. breached in the following cases: (continued)
 Willfully or negligently dangerous practices When responding to a subpoena duces tecum and subpoena
will be against the law. ad testificandum issued by a Court with jurisdiction over a legal
 Article 3: TESTING, SCREENING AND proceeding where the main issue is the HIV status of an
COUNSELLING individual:
 The Government will provide appropriate confidential  Provided, That the confidential medical record shall
HIV testing. be properly sealed by its lawful custodian after being
 HIV testing can only be done with the double-checked for accuracy by the head of the office
consent of the person tested. or department, hand delivered, and personally
 The DOH will provide anonymous HIV opened by the judge:
testing.  Provided, further, That the judicial proceedings be
 Counseling will be conducted before and held in executive session.
after testing.  Section 32. Release of HIV/AIDS test results.
 The DOH will make adequate and affordable All results of HIV/AIDS testing shall be confidential and shall be
HIV testing available in all of the Philippines. released only to the following persons:
 Article 4: HEALTH AND SUPPORT SERVICES (a) the person who submitted himself/herself to such test;
 The Government will ensure adequate health and (b) either parent of a minor child who has been tested;
support services for people with HIV. (c) a legal guardian in the case of insane persons or
 Hospitals will provide adequate care for orphans;
persons with HIV. (d) a person authorized to receive such results in
 LGUs must provide community-based conjunction with the AIDSWATCH program as
prevention and care efforts. provided in Sec. 27 of this Act;
 Livelihood efforts will be made available for (e) a justice of the Court of Appeals or the Supreme
people with HIV. Court, as provided under subSec. (c) of this Act and
 The DOH is to do STD prevention and in accordance with the provision of Sec. 16 hereof.
control efforts.  Section 33. Penalties for violations of
 The DOH is to make sure that health confidentiality.
insurance is available to people with HIV. Any violation of medical confidentiality as provided in Sec.s 30
 Article 5: MONITORING and 32 of this Act shall suffer the penalty of:
 The Government will monitor HIV/AIDS  imprisonment for six (6) months to four (4) years,
 The Government will establish an without prejudice to administrative sanctions such as
AIDSWATCH council. fines and suspension or revocation of the violator's
 Reporting procedures will be developed to license to practice his/her profession,
track HIV rates, while respecting client  as well as the cancellation or withdrawal of the license
confidentiality. to operate any business entity and the accreditation of
 Contract tracing is permitted provided hospitals, laboratories or clinics.
confidentiality is not breached.  Section 34. Disclosure to sexual partners.
 Article 6: CONFIDENTIALITY  Any person with HIV is obliged to disclose his/her HIV
 Confidentiality will be protected on HIV status. status and health condition to his/her spouse or
 All healthcare workers, and anyone handling sexual partner at the earliest opportune time.
health records will strictly preserve patient  Article 7: DISCRIMINATORY ACTS AND POLICIES
confidentiality on HIV status, and the identity  Discrimination against people with HIV is illegal.
of people with HIV.  Employers cannot discriminate in hiring, firing,
 HIV results may be given to the person promotion, or assignment based on actual or
tested, an official of the AIDSWATCH suspected HIV status.
council, and a parent or guardian. It cannot  Schools are not allowed to refuse admission, punish
be given to anyone else. students, or deny participation in activities based on
 Legal penalties can be provided for real or perceived HIV status.
breaching confidentiality. ¡ People with HIV  A person with HIV has the legal right to travel, live,
must inform spouses and sex partners as and lodge with the same freedom as any other citizen.
soon as reasonably possible. Quarantines and other restrictions are illegal.
 Exceptions to the mandate of confidentiality.  A person with HIV has every legal right to seek public
Medical confidentiality shall not be considered breached in the office.
following cases:  Credit services cannot be denied based on HIV
when complying with reportorial requirements in conjunction status. Insurance cannot be refused based on HIV
with the AIDSWATCH programs provided in Sec. 27 of this status, provided the person does not lie about their
Act; HIV status.
 ARTICLE V  Hospitals and health services cannot refuse treatment
MONITORING or discriminate based on HIV status.
Sec. 27. Monitoring program  Decent burials cannot be denied based on HIV status.
A comprehensive HIV/AIDS monitoring program  Legal penalties for discrimination will be enforced.
or "AIDSWATCH" shall be established under the Department  Section 42. Penalties for discriminatory acts and
of Health: policies.
 to determine and monitor the magnitude and All discriminatory acts and policies referred to in this Act shall
progression of HIV infection in the Philippines, be punishable with a penalty of:
 and for the purpose of evaluating the adequacy and  imprisonment for six (6) months to four (4) years
efficacy of the countermeasures being employed.

Medtech Laws and Ethics || Inosanto Notes | 12


 and a fine not exceeding Ten thousand pesos All members of the Council shall be appointed by the President
(P10,000.00). of the Republic of the Philippines:
In addition, licenses/permits of schools, hospitals and other  except for the representatives of the Senate and the
institutions found guilty of committing discriminatory acts and House of Representatives, who shall be appointed by
policies described in this Act shall be revoked. the Senate President and the House Speaker,
 Article 8 THE PHILIPPINE NATIONAL AIDS respectively;
COUNCIL  The Secretary of Health shall be the permanent
 The government will establish a Philippine National chairperson of the Council;
AIDS Council. however, the vice-chairperson shall be elected by its members
 The Council shall likewise ensure that there is from among themselves, and shall serve for a term of two (2)
adequate coverage of the following: years; and
 The institution of a nationwide HIV/AIDS For members representing medical/health professional groups
information and education program; and the six (6) non-government organizations:
 The establishment of a comprehensive  they shall serve for a term of two (2) years, renewable
HIV/AIDS monitoring system; upon recommendation of the Council.
 The issuance of guidelines on medical and  Section 46. Reports. –
other practices and procedures that carry the The Council shall submit to the President and to both Houses
risk of HIV transmission; of Congress comprehensive annual reports on the activities
 The provision of accessible and affordable and accomplishments of the Council.
HIV testing and counseling services to those  Such annual reports shall contain assessments and
who are in need of it; evaluation of intervention programs, plans and
 The provision of acceptable health and strategies for the medium- and long-term prevention
support services for persons with HIV/AIDS and control program on HIV/AIDS in the Philippines.
in hospitals and in communities;  Section 47. Creation of Special HIV/AIDS
 The protection and promotion of the rights of Prevention and Control Service. –
individuals with HIV; and There shall be created in the Department of Health a Special
 The strict observance of medical HIV/AIDS Prevention and Control Service:
confidentiality  staffed by qualified medical specialists and support
 Section 45. Membership and composition. staff with permanent appointment
The Council shall be composed of twenty-six (26) members as  and supported with an adequate yearly budget.
follows:  It shall implement programs on HIV/AIDS prevention
 (1) The Secretary of the Department of Health; and control.
 (2) The Secretary of the Department of Education,  In addition, it shall also serve as the secretariat of the
Culture and Sports or his representative; Council.
 (3) The Chairperson of the Commission on Higher  Section 48. Appropriations. –
Education or his representative;  The amount of Twenty million pesos
 (4) The Director-General of the Technical Education (P20,000,000.00) shall be initially appropriated out of
and Skills Development Authority or his the funds of the National Treasury.
representative;  Subsequent appropriations shall be provided by
 (5) The Secretary of the Department of Labor and Congress in the annual budget of the Department of
Employment or his representative; Health under the General Appropriations Act.
 (6) The Secretary of the Department of Social Welfare  ARTICLE IX
and Development or his representative; MISCELLANEOUS PROVISIONS
 (7) The Secretary of the Department of the Interior Sec. 49. Implementing rules and regulations. –
and Local Government or his representative;  Within six (6) months after it is fully reconstituted, the
 (8) The Secretary of the Department of Justice or his Council shall formulate and issue the appropriate
representative; rules and regulations necessary for the
 (9) The Director-General of the National Economic implementation of this Act.
and Development Authority or his representative; Section 50. Separability clause. –
 (10) The Secretary of the Department of Tourism or  If any provision of this Act is declared invalid, the
his representative; remainder of this Act or any provision not affected
 (11) The Secretary of the Department of Budget and thereby shall remain in force and effect.
Management or his representative; Section 51. Repealing clause. –
 (12) The Secretary of the Department of Foreign  All laws, presidential decrees, executive orders and
Affairs or his representative; their implementing rules inconsistent with the
 (13) The Head of the Philippine Information Agency or provisions of this Act are hereby repealed, amended
his representative; or modified accordingly.
 (14) The President of the League of Governors or his Section 52. Effectivity. –
representative;  This Act shall take effect fifteen (15) days after its
 (15) The President of the League of City Mayors or publication in at least two (2) national newspapers of
his representative; general circulation.
 (16) The Chairperson of the Committee on Health of  Approved:
the Senate of the Philippines or his representative; February 13, 1998
 (17) The Chairperson of the Committee on Health of
the House of Representatives or his representative; Administrative Order No. 2010 - 0028
 (18) Two (2) representatives from organizations of
medical/health professionals; POLICIES AND GUIDELINES IN THE CONDUCT
 (19) Six (6) representatives from non-government OF HUMAN IMMUNODEFICIENCY VIRUS (HIV)
organizations involved in HIV/AIDS prevention and
control efforts or activities; and
COUSELING AND TESTING IN COMMUNITY
 (20) A representative of an organization of persons AND HEALTH FACILITY SETTINGS
dealing with HIV/AIDS.
Presented by:
 To the greatest extent possible, appointment to the
Council must ensure sufficient and discernible JC John T. Jamili, RMT, MSMT-CAR
representation from the fields of medicine, education,
health care, law, labor, ethics and social services; I. INTRODUCTION AND RATIONALE

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The Philippines still maintains less than one (1) percent IV. DEFINITION OF TERMS
prevalence rate of HIV infection.
1. Blood Service Facility (BSF)
Preventive interventions must be undertaken by the country in
order to maintain its low prevalence status, and the – any unit, office or institution providing any of the blood
Department of Health and other concerned agencies are transfusion services and which can be a blood center, blood
focusing their efforts thereon. bank, blood collection unit or blood station.

Pursuant to the 4th Medium Term Plan (2005 – 2010): 2. Confirmatory test/testing

HIV counseling and testing is one of the preventive – refers to the test performed on samples that have tested
interventions used to reach the most at risk population. reactive to the screening test to find out if the results were true
positive or not.
The at–risk and vulnerable populations for HIV infection
include: 3. DOH Retained Hospitals

people in prostitutions – hospitals that remain under the management and supervision
of the Department even after the devolution.
men having sex with men
4. Fourth AIDS Medium Term Plan
people who inject drugs
– the five–years plan containing the country’s action and
migrant workers response towards maintaining the low HIV prevalence status of
the Philippine and preventing the spread of HIV infection.
HIV counseling and testing is being advocated to the most at
risk population because through this intervention: 5. Informed written consent

the same are given the opportunity to known their HIV status – refers to the voluntary written agreement of a person allowing
him/herself to undergo or be subjected to a procedure based
and at the same time are provided with information on risk on full information.
reduction strategies and location of facilities to treat HIV
positive individual. 6. Overseas Filipino Workers (OFW) clinics

Since counseling is anchored on HIV testing: – these are clinics that conduct pre – employment medical
examinations for Filipinos bound for abroad.
efficient post–test counseling can appropriately manage the
negative consequences of client’s knowing their HIV status 7. Pre–donation counseling
especially if the client tested positive for HIV.
– a process in blood donor selection wherein donors are
On the other hand, poor quality counseling which may informed about health conditions or risk behavior that would
inadequately address client issues may result in: make them unsuitable to donate blood. The donor’s informed
consent to blood donation and to the blood testing is obtained
suicide, depression and other psychological consequences in during counseling.
persons tested positive for HIV.
8. Reactive sample
Furthermore, the importance of implementing quality
counseling anchored on HIV testing as mandated by Republic – the blood sample from the patient/client has antibodies that
Act No. 8504, “AIDS Prevention and Control Act of 1988,”: reached to the HIV antigen or vice versa in the screening test.
However, the presence of reactive sample does not totally
will not only benefit the individual being tested confirm that the person has HIV infection.
but will also scale up preventive interventions so as to slow 9. Screening test
down or halt the spread of HIV.
– refers to the initial serological test performed to determine
Hence, there is a need to provide a standard in the conduct of the presence of antibody and/or antigen against HIV1 and
HIV counseling and testing. HIV2.
II. OBJECTIVES 10. Social Hygiene Clinics
General Objective – these are clinics of the local government unit that are usually
part of the municipal/city health office providing reproductive
To provide policies and guidelines in the conduct of HIV
health service including management of STI.
counseling and testing (HCT) at community and health facility
settings. 11. Treatment hub
Specific Objectives: – a hospital facility with an organized HIV/AIDS Core Team
(HACT) providing prevention, treatment care and support
1. To identify the required components of HIV
services to People Living with HIV (PLHIV) including but not
counseling and testing and set the protocol for these
limited to:
components;
HIV counseling and testing
2. To set the standards/requirements for an HIV
counseling and testing facility; and clinical management
3. To define the roles and responsibilities of DOH and patient monitoring
other stakeholders in the implementation of these
guidelines. and other care and support services.

III. SCOPE AND COVERAGE ARV treatment can only be accessed through these
facilities. Refer to ANNEX II for the list of treatment hubs.
This guideline covers all Sexually Transmitted Infection (STI)
and HIV service providers, coordinators and managers of HIV 12. HIV Counseling and Testing (HCT)
clinics and/or testing laboratories, all facilities offering HIV
testing for diagnostic purposes, surveillance and research, and
blood safety purposes.

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– also called Voluntary Counseling and Testing (VCT), is a facilities for LGU and NGO based HIV counseling and testing
counseling process that enables a client make an informed facilities.
choice about being tested for HIV.
7. Private and LGU hospitals shall be encouraged to set up
The counseling process has two components: within their systems provisions of HIV counseling and testing
services for walk in clients.
a. pre HIV test counseling
The said services shall be closely linked to the HACT of the
b. post HIV test counseling hospital.
a. Pre–HIV test counseling 8. All persons who underwent HCT shall be provided with their
test results with post – test counseling
– a process that prepares the client for the HIV test.
except for testing done during blood donation, surveillance and
Pre –HIV test counseling explains the implications of knowing
research purposes.
that one is or is not infected with HIV, facilitates discussion
about ways to cope with knowing one’s HIV status, to enable No other person shall be provided with the result other than the
an individual to practice strategy to reduce future risk person tested except in circumstances allowed by R.A. 8504 or
behaviors. similar guidelines.
It can be Client initiated (CICT) or provider initiated HIV VI. SPECIFIC GUIDELINES
counseling and testing (PICT),
1. Conduct of Pre–HIV Test Counseling
Both process is voluntary and enables client to make informed
decision about being tested for HIV infection. a. Client–Initiated Counseling and Testing

b. Post HIV test counseling (1) All clients who want to be tested for HIV shall be provided
with pre–HIV test counseling in a space where privacy could
– process conducted by a trained personnel to assist the client be observed and confidentiality ensured.
understand and cope with the HIV test result and be able to
identify options for future plans including physical, mental, (2) Pre–HIV test counseling shall either be conducted in
social, reproductive and other personal concerns. individual or group settings. Client shall be strongly
encouraged to bring their confidants during the pre– and post–
13. HCT facility HIV test counseling.
– any health facility equipped in providing services on HIV (3) The same counselor is highly recommended to conduct
counseling and testing recognized by DOH. both pre– and post– test counseling and, if needed, follow–up
sessions for a client.
It can be free–standing or incorporated into existing health–
care services. (4) Adult clients shall be counseled in a setting that is safe
and secure for both counselor and client.
V. GENERAL GUIDELINES
(5) Pre– and post–HIV test counseling of children
1. All HCT facilities shall observe the principles of
counseling, informed consent and confidentiality at all shall take into consideration the maturity of the client
times.
and, when necessary, responsible parents or a legal guardian,
(Refer to Annex I for Minimum Information provided during including any registered social worker, shall be involved.
Pre–test Counseling).
(6) Counselors shall ensure that clients understand the
2. All HCT facilities shall be duly licensed and comply with the information printed on the consent form. All necessary and
standards set by the Department of Health for an HIV Testing correct information that clients need to make decisions for
Center. themselves shall be provided.
3. All Social Hygiene Clinics (SHC) shall offer to most at risk (7) Counselors shall strongly encourage follow–up counseling
and vulnerable clients HIV counseling and testing services or sessions and ensure that clients utilize referral networks that
referral at regular intervals. are in place and functional.
4. All DOH–licensed OFW clinics shall provide pre–HIV and (8) All Counselors shall have basic knowledge on voluntary
post–HIV test counseling to all their clients for HIV testing blood donation and incorporate facts on blood donation when
appropriate.
as mandated by Republic Act No. 8504, “AIDS Prevention and
Control Act of 1998.” b. Provider–Initiated Counseling and Testing
Provision for counseling shall be part of the accreditation (1) As part of medical management, HIV testing shall be
requirements of OFW clinics. offered by health care provider to ALL the following:
5. Blood service facilities (BSF) shall include it its pre–donation (a) Clients assessed for STI in an STI clinic or elsewhere;
counseling an assessment of risk behavior among all its
potential blood donors. (b) Pregnant women with one or more of the following HIV
risks:
All individuals seen at BSF with high risk behavior among all its
potential blood donors. · Multiple sex partners,

All individuals seen at BSF with high risk behavior shall be · Persons who inject drugs (PWID),
deferred and shall be referred to a HCT facility for counseling
and HIV testing. · History of STI, including a diagnosis of syphilis

6. All identified treatment hubs (See Annex II) and DOH– · Husband or partner has multiple sex partners, history of STI
retained hospitals shall: or is a known PWID

set– up and provide HIV counseling and testing as part of HIV As part of medical management, HIV testing shall be offered
AIDS Core Team (HACT) services and as potential referral by health care provider to ALL the following: (continued)

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(c) People accessing community – based services designed SACCL and RITM are required to report the confirmed positive
for males having sex with males, people in prostitution and samples to the National Epidemiology Center (NEC).
those who inject drugs;
It is the responsibility of the BSF to ensure that donors have
(d) Diagnosed TB patients, as discussed in A.O. 2008 – 0022, been screened properly and pre–donation counseling has
otherwise known as “Policies and Guideline in the been provided to all potential blood donors:
Collaborative approach of TB and HIV Prevention and Control.”
in order to prevent the occurrence of reactive and positive
(e) Patients showing signs and symptoms consistent with samples
HIV–related diseases or AIDS seen by the attending physician.
by eliminating those individual with high risk behaviors.
(f) Parents/Guardians of all children born to HIV infected
mothers (or those with possible exposure). For confirmed positive blood units:

(2) Basic conditions on confidentiality, informed consent, and tracing the donor and informing him/her of the result is
counseling shall be adhered to. not recommended

(3) Pre–HIV test counseling shall be limited to basic Providing result to a free HIV test can put the blood supply at
information – giving that would help the patient decide whether risk as high risk individuals within the window period may avail
to accept HIV testing (See Annex I). of this free services.

(4) Post–HIV test counseling services shall be provided to all Information campaign on HIV services available and stigma
clients tested by trained personnel (See Annex III). reduction activities will be intensified by CHD in areas where
positive blood units are identified.
(5) Counselors providing post–test counseling services shall
emphasize prevention for those that tested negative and, 4. Conduct of Post–HIV test Counseling
medical and psychosocial support to those that tested positive.
Post–HIV test counseling shall be provided together with the
(6) The capacities for pre and post HIV test counseling release of the test result whether the test is negative or
including the capacity to provide medical and psychosocial positive.
support shall be enhanced and the referral networks between
It shall be done in an enclosed space where counseling can be
and among these providers shall be functional.
done in privacy.
2. Conduct of HIV Testing
It is recommended that the trained counselor who performed
Only registered medical technologist the pre–test counseling shall also provide the post – test
counseling.
with HIV proficiency training
Refer to Annex III for the list of information that should be
shall perform the HIV test using: disclosed to the clients/patients during post–test counseling.

Food and Drug Administration (FDA) registered test kits. 5. Special Concerns on Post HIV Test Counseling: Infant
Feeding
Other screening tests may be performed including but not
limited to: HIV–Infected pregnant women shall also be given information
on the risk and benefits of exclusive breastfeeding, exclusive
Enzyme Immunoassay (EIA), replacement feeding and guidance in selecting the most
suitable option in their circumstances.
Particle Agglutination (PA)
(The entire spectrum of preventing mother to child
and Rapid Assay (RA).
transmission of HIV is described under A.O. No. 2009 – 0016).
Reactive samples from clients/patients:
VII. REQUIREMENTS FOR AN HIV COUNSELING AND
shall be brought to the STD/AIDS Central Cooperative TESTING FACILITY
Laboratory (SACCL) at the San Lazaro Hospital for
1. Human Resources
confirmatory testing
a. Physician, allied medical/social welfare personnel trained in
(Refer to Annex IV for the Current HIV Diagnostic Testing
conducting pre–test and post–test counseling for HIV by DOH
Algorithm).
or any of its recognized organizations.
For reactive blood units (not person) from blood banks:
b. Registered Medical Technologist with training on HIV
samples shall be referred to the Research Institute for Tropical proficiency testing
Medicine (RITM) for confirmatory testing.
2. HIV test kits
3. Release and Reporting of Test Result
a. Only FDA registered test kit or other available screening test
Samples reactive to screening test shall not be reported (EIA/PA/RA) shall be used in HIV testing;
directly to the client/patient.
b. For HCT facilities with no HIV testing capacity, there shall be
All reactive samples shall be referred for confirmatory testing. an explicit linkage to any DOH–accredited HIV laboratory for
HIV testing.
The reference laboratories namely SACCL and RITM:
c. Space – an enclosed room or devoted section/space where
shall not release the result of the confirmatory test directly to counseling can be done in privacy.
the patient/client under any circumstance
d. Annual certification of satisfactory performance in the
but must send the result to the referring HIV testing facility. National External Quality Assurance Programme of NRL–
SACCL or its designate.
This is to ensure that the release of the HIV test shall be
accompanied by post–test counseling especially if the result is VIII. ROLES AND RESPONSIBILITIES
positive.
1. National Center for Disease Prevention and Control

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a. Advocate the setting up of HCT facilities to the local Additional information for women who are or may become
government units (LGU)/hospitals/health facilities as a pregnant:
preventive intervention in reaching the most risk population.
1. The risk of transmitting HIV to the infant;
b. Conduct awareness campaign on HIV and AIDS in the
workplace including the availability of HIV counseling services 2. Measure that can be taken to reduce mother–to–child
either by the DOH–licensed HIV laboratory staff and/or HIV transmission, including anti–retroviral prophylaxis and infant
AIDS Core Team. feeding counseling;

IX. FUNDING 3. The benefits to infants of early diagnosis of HIV

The Infectious Disease Office of the NCDPC shall allocate Annex II


budget for the implementation of these policies and guidelines List of Treatment Hubs in the Philippines
including but not limited to fund for the augmentation of HIV
A. Luzon
test kits and funds for training.
1. San Lazaro Hospital
Other DOH Offices including CHD and DOH– retained
hospitals shall support financially, as part of their annual 2. Research Institute for Tropical Medicine
budget, the implementation of these policies and guidelines.
3. Philippine General Hosptial
X. REPEALING CLAUSE
4. Ilocos Training and Regional Medical Center
Provisions in previous issuances that are inconsistent and
contrary to this Administrative Order are hereby rescinded and 5. Baguio General Hospital and Medical Center
repealed.
6. Bicol Regional Training and Teaching Hospital
XI. EFFECTIVITY
7. Cagayan Valley Medical Center
This Administrative Order shall take effect immediately:
8. Jose B. Lingad Memorial Regional Hospital
September 27, 2010
B. Visayas
ENRIQUE T. ONA, MD, FPCS, FACS
1. Vicente Sotto Memorial Medical Center
Secretary of Health
2. Western Visayas Medical Center
ANNEX I
3. Corazon Locsin Montelibano Memorial Regional Hospital
MINIMUM INFORMATION PROVIDED DURING PRE–TEST
COUNSELING C. Mindanao
(Adapted from Guidance on Provider–Initiated HIV Testing and
Counseling in Health Facilities, WHO–UNAIDS 2007) 1. Davao Medical Center

1. The reason why HIV testing and counseling is being 2. Zamboanga City Medical Center
recommended;
Annex III
2. The clinical and prevention benefits of testing and potential MINIMUM INFORMATION GIVEN DURING POST–TEST
risks, such as discrimination, abandonment or violence. COUNSELING
(Adapted from Guidance on Provider–initiated HIV Testing and
3. The services that are available in the case of either and Counseling in Health Facilities, WHO–UNAIDS 2007)
HIV–negative or an HIV–positive test result, including whether
anti–retroviral treatment is available; Post–test counseling for HIV–negative persons

4. The fact that the test result will be treated confidentially and Counseling for individuals with HIV–negative test results
will not be shared with anyone other than health care providers should include the following minimum information:
directly involved in providing services to the patient;
1. An explanation of the test result, including information about
5. The fact that the patient has the right to decline the test and the window period for the appearance of HIV–antibodies and a
that testing will be performed unless the patient exercises that recommendation to a re–test in case of a recent exposure;
right;
2. Basic education on method to prevent HIV transmission;
6. The fact that declining an HIV test will not affect the patient’s
access to services that do not depend upon knowledge of HIV 3. Education on condoms and guidance on their use.
status;
4. The health care provider and the patient should then jointly
7. In the event of an HIV–positive test result, encouragement of assess whether the patient needs referral to more extensive
disclosure to other persons who may be at risk of exposure to post–test counseling session or additional prevention support,
HIV; for example, through community–based services and VCT
facilities with CICT capacity.
8. An opportunity to ask the health care provider questions;
Post–test counseling for HIV–positive persons
9. Patients should also be made aware of relevant laws in
jurisdictions that mandate the disclosure of HIV status to The focus of post–test counseling for people with HIV–positive
sexual and/or drug injecting partners. results is psychosocial support to cope with the emotional
impact of the test result, facilitate access to treatment, care
Other information/topics that should be included during Pre– and prevention services, prevention of transmission and
HIV test counseling (client– initiated) disclosure to sexual and injecting partners. Health care
providers should:
1. Risk assessment and risk reduction strategies
1. Inform the patient of the result simply and clearly, and give
2. Promotion and facilitation of behavior change the patient time to consider it;
3. Ways of coping positive results 2. Ensure that the patient understands the result;
4. Exploration of potential support for family or friends 3. Allow the patient to ask questions;

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4. Help the patient to cope with emotions arising from the test
result;

5. Discuss any immediate concerns and assist the patient to


determine who in her/his social network may be available and
acceptable to offer immediate support;

6. Describe follow–up services that are available in the health


facility and in the community, with special attention to the
available treatment, PMTCT and care and support services;

7. Provide information on how to prevent transmission of HIV,


including provision of male and female condoms and guidance
on their use;

8. Provide information on other relevant preventive health


measures such as good nutrition, use of cotrimoxazole and TB;

9. Discuss possible disclosure of the result, when and how this


may happen and to whom;

10. Encourage and offer referral for testing and counseling of


partners and children;

11. Assess the risk of violence or suicide and discuss possible


steps to ensure the physical safety of patients, particularly
women;

12. Arrange for a specific date and time for follow up visits or
referrals for treatment, counseling, support and other services
as appropriate (TB screening and treatment, antenatal care,
access to sterile needles and syringes).

ANNEX IV–A
CURRENT HIV DIAGNOSTIC TESTING ALGORITHM FOR
ADULTS AND INFANTS ≥18 MONTHS OLD

a. HIV test kits with ≥99% specificity are used for the first
screening process.

b. Samples that turned out to be non–reactive on the first


screening test are considered seronegative and the client is
given a negative rest report. No further testing is required.

c. Samples found sero–reactive by all HIV screening test will


be sent to the referral laboratory (SACCL) for confirmatory
testing.

d. Sero–reactive samples will be tested on SACCL with 2


different test formats (PA and EIA Ag/Ab).

If one or both of the tests on parallel examinations is positive


then Western Blot test will be performed on the sample.

If both tests are negative then a negative test report will be


released.

e. Samples that are positive on Western blot will be reported


as positive and those that are negative will be reported as
negative.

If the result is intermediate, repeat follow up testing may be


required (3,6 and 12 months).

If the results remain indeterminate after 1 year, the person is


considered to be HIV antibody negative. The client is given a
negative test report.

f. Client should be advised to come back to the HIV


counseling and testing (VCT) facility after an estimated turn–
around time.

g. The client is given HIV test report after conducting post–test


counseling.

ANNEX IV–B
CURRENT HIV DIAGNOSTIC TESTING ALGORITHM FOR
INFANTS <18 MONTHS OLD

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