REPUBLIC ACT NO.
10912 • Improves productivity with the help of motivated and
“Continuing Professional Development Act of 2016”
CONTINUING PROFESSIONAL DEVELOPMENT
• Continuing means without break in continuity
• Professional means person’s work requiring special
training
• Development means a process of growing or
changing and becoming more advanced
• Process of honing the knowledge, skills and attitude
of a professional
− “EDUCATION IS NOT THE LEARNING OF FACTS,
BUT THE TRAINING OF THE MIND TO THINK.”
REPUBLIC ACT 10912
• Otherwise known as the “Continuing Professional
Development (CPD) Act of 2016”, is an act which
requires CPD as the mandatory requirement for the
renewal of Professional Identification Card.
• Fusion of Senate Bill No. 2581 and House Bill No.
6423 = CPD Law of 2016
• Senate Bill No. 2581, which was approved by the
Senate on August 3, 2015, was adopted as an
amendment to House Bill No. 6423 by the House of
Representatives on May 23, 2016.
• The CPD Act Lapsed into Law on July 21, 2016 and
it took effect on August 16, 2016.
• Approved: July 21, 2016 by President Benigno S.
Aquino III
DEFINITION OF TERMS
• AIPO/APO refers to the Accredited Integrated
Professional Organization or the Accredited
Professional Organization in a given profession.
• 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, acquired in different ways and
methods by learners and workers.
DECLARATION OF POLICY
• It is hereby declared the policy of the State to promote
and upgrade the practice of professions in the
country. Towards this end, the State shall institute
measures that will continuously improve the
competence of the professionals in accordance with
the international standards of practice, thereby,
ensuring their contribution in uplifting the general
welfare, economic growth and development of the
nation.
PROFESSIONALS
• Improves the competence of the professionals in
accordance with the international standards of
practice; ensures your capabilities keep pace with the
current standards meaning it ensures that you and
your knowledge stay relevant and up to date.
• As our skills and knowledge matures (indication of
confidence)
• Opens doors to excellent future employment
opportunities
skilled employees
• Delivers a deeper understanding of what it means to
be a professional, along with a greater appreciation of
the implications and impacts of your work.
PROFESSIONAL’S CAREER AND PRACTICE OF
PROFESSIONS
• Ensures that we maintain and enhance the
knowledge and skills we need to deliver a
professional service to your customers, clients and
the community.
• 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
• 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
STRENGTHENING THE CPD PROGRAMS
There shall be formulated and implemented CPD
Programs in each of the regulated professions in order to:
1. Enhance and upgrade the competencies and
qualifications of professionals for the practice of their
professions pursuant to the PQF, the AQRF and the
ASEAN MRAs;
2. Ensure national and international alignment of
competencies and qualifications of professionals
through career progression mechanism leading to
specialization/ sub-specialization
3. Ensure the development of quality assured
mechanisms for the validation, accreditation and
recognition of formal, non-formal and informal
learning outcomes, including professional work
experiences and prior learning
4. Respond to national, regional and international labor
market and industry needs.
5. Recognize and ensure the contributions of
professionals in uplifting the general welfare,
economic growth and development of the nation.
NATURE OF CPD PROGRAMS
The CPD Programs consist of activities that range from
structured to non-structured activities, which have
learning processes and outcomes. These include, but not
limited to the following:
1. FORMAL LEARNING
• Doctoral Degree, Master’s Degree, Post-graduate
Diploma/Certificate/Diplomate/Fellowship Program
2. NON-FORMAL LEARNING
• Professional activities: conference,
seminar/workshop/colloquium, in-service training,
webinar, tutorial, study tour/plant visit, exhibit, poster
presentation, program/module development,
publication, invention, consultancy, and
recognition/award/title
• Volunteer engagement: medical mission/outreach
program, environmental initiative, livelihood program,
disaster/calamity assistance, service to worthy
projects and CSR projects
3. INFORMAL LEARNING
• Reading of books, magazine journals, and the like
that will develop leadership, management, and other
skills
4. ONLINE LEARNING ACTIVITIES
5. PROFESSIONAL WORK EXPERIENCE
• Reading of books, magazine, journals, and the like on
how to improve knowledge and skills in the field of
professional practice
• Providing professional consultancy services to clients
POWER, FUNCTIONS AND RESPONSIBILITIES OF
THE PRC AND THE PROFESSIONAL REGULATORY
BOARD
1. Organize CPD Council for each of the regulated
professions and promulgate guidelines for their
operation
2. Review existing and new CPD Programs for all the
regulated professions
3. Formulate, issue and promulgate guidelines and
procedures for the implementation of the CPD
Programs
4. Coordinate with academe, concerned government
agencies and other stakeholders in the
implementation of the CPD Programs and other
measures
5. Coordinate with concerned government agencies in
the development of mechanisms and guidelines, in
the grant and transfer of credit units earned from all
learning processes and activities
CPD COUNCIL
• The chairperson of the CPD Council shall be the
member of the PRB so chosen by the PRB concerned
to sit in the CPD Council.
• First member: president or officer of the AIPO/APO
duly authorized by its Board of Governors/Trustees.
− Absence of the AIPO/APO: the PRB concerned shall
submit within ten (10) working days from notification
of such absence, a list of three (3) recommendees
from the national professional organizations. The
PRC shall designate the first member within thirty (30)
days from receipt of the list.
• Second member: president or officer of the national
organization of deans or department chairpersons of
schools, colleges or universities offering the course
requiring the licensure examination.
− Absence of such organization: the PRB concerned
shall submit, within ten (10) working days from
notification of such absence, a list of three (3)
recommendees from the academe. The PRC shall
designate the second member within twenty (20)
working days from receipt of the list.
• The term of office of the chairperson of the CPD
Council shall be coterminous with his/her incumbency
in the PRB unless sooner replaced by the PRB
concerned through a resolution, subject to the
approval of the PRC.
• The first and second members shall have a term of
office of two (2) years unless sooner replaced through
a resolution by the AIPO/APO concerned or the
organization of deans or heads of departments,
respectively. However, members of the CPD Council
who are appointed by the PRC may be replaced
before the end of the two (2)-year period, upon the
recommendation of the PRB through a resolution.
POWERS, FUNCTIONS AND RESPONSIBILITIES OF
THE CPD COUNCIL - THE CPD COUNCIL FOR EACH
PROFESSION
• Ensure the adequate and appropriate provision of
CPD Programs for their respective profession;
• Evaluate and act on applications for accreditation of
CPD Providers and their CPD Programs;
• Monitor and evaluate the implementation of the CPD
Programs;
• Assess and/or upgrade the criteria for accreditation of
CPD Providers and their CPD Programs on a regular
basis;
• Develop mechanisms for the validation, accreditation
and recognition of self-directed learning,
prior/informal learning, online learning, and other
learning processes through professional work
experience;
• Conduct researches, studies and benchmarking for
international alignment of the CPD Programs;
• Issue operational guidelines, with the approval of the
PRC and the PRB concerned; and
• Perform such other functions related or incidental to
the implementation of the CPD.
CPD PROGRAM IMPLEMENTATION AND
MONITORING
• The CPD is hereby made as a mandatory
requirement in the renewal of the PICs of all
registered and licensed professionals under the
regulation of the PRC.
• All duly validated and recognized CPD credit units
earned by a professional shall be accumulated and
transferred in accordance with the Pathways and
Equivalencies of the PQF.
• The PRC and the PRBs, in consultation with the
AIPO/APO, the Civil Service Commission (CSC),
other concerned government agencies and industry
stakeholders, shall formulate and implement a Career
Progression and Specialization Program for every
profession. The Career Progression and
Specialization Program shall form part of the CPD.
• All concerned government agencies and private firms
and organizations employing professionals shall
include the CPD as part of their human resource
development plan and program.
FINAL PROVISIONS
• The funding requirement herein mentioned shall be
used for the regular operations of the CPD Councils,
including the monitoring of the conduct of the CPD
Programs.
• The PRC shall review and approve the proposed
budget for each CPD Council, taking into
consideration the reasonable expenses that will be
incurred for travel, honorarium/allowances, and per
diems, when attending official CPD Council meetings
or performing other related functions assigned to
them.
• The PRC and the PRBs, in consultation with the
AIPO/APO and other stakeholders, shall promulgate
the implementing rules and regulations (IRR) within
six (6) months from the effectivity of this Act.
• Fraudulent acts relating to the implementation and
enforcement of this Act shall be punishable under the
pertinent provisions of the Revised Penal Code, the
New Civil Code and other applicable laws.
• A professional who is adjudged guilty of any
fraudulent act relating to the CPD shall also be meted
with the penalty of suspension or revocation of his/her
PRC Certificate of Registration and/or Certificate of
Specialization. In case of a government official or
employee who is party to any fraudulent act relating
to the CPD, he/she shall also be subject to the
administrative penalties that may be imposed under
the anti-graft laws, the Administrative Code and the
Code of Conduct of Public Officials and Employees.
• Separability Clause. If any part or provision of this
Act is declared invalid or unconstitutional, the other
 provisions not affected thereby shall remain in full
force and effect.
• Repealing Clause. All laws, decrees, executive
orders and other administrative issuances or parts
thereof, which are inconsistent with the provisions of
this Act, are hereby repealed or modified accordingly.
• Effectivity. - This Act shall take effect fifteen (15)
days following its complete publication in the Official
Gazette or in two (2) newspapers of general
circulation in the Philippines.
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
• Every CPD Council shall be composed of chairperson
and two (2) members.
• The Chairperson shall act in the following functions:
− Preside the meetings
− Direct or supervise the activities
− Submit the Council’s annual report to the
Planning and Monitoring Division not later than
January 15 of the succeeding year
− Sign the following:
▪ CoA: Certificate of Accreditation of qualified
CPD providers
▪ CoAP: Certificate of Accreditation of Program
▪ CCU: Certificate of Credit Units for self-
directed and/pr lifelong learning
CPD PROVIDERS
• Local CPD Provider
− Individual/Sole Proprietor
− Firm/Partnership/Corporation
− Government Institutions/Agencies
• Foreign CPD Provider
− Foreign Entity/Firm /Association
FREQUENTLY ASKED QUESTIONS
• Where to get the application forms?
− The Continuing Professional Development (CPD)
forms can be downloaded from PRC website at
www.prc.gov.ph or available at Standards and
Inspection Division office.
• How long is the processing of the application for
accreditation as CPD Provider?
− The period for processing the application is 30 days.
• What is the validity of accreditation for CPD
Provider?
− The accreditation of CPD Provider is valid for three
(3) years.
• What is the regulatory period for the filing of
application for accreditation of CPD program/s?
− The CPD Program/s shall be applied 45 days prior to
the conduct of the program
• How much are the prescribed fees for
accreditation of CPD Providers, CPD Programs,
Self-Directed Learning and/or Lifelong Learning?
− The Prescribed fees for accreditation are as follows:
− Local CPD provider P 5,000.00
− Foreign CPD provider P 8,000.00
− CPD program per offering P 1,000.00
− Self-directed and/or Lifelong Learning per program P
500.00
• Who are not covered by the CPD Requirement?
− Professionals working overseas. However, they need
to provide proof such as valid Certificate of
Employment or Overseas Employment Certificate
duly approved by POEA.
− Newly licensed professionals for the first renewal
cycle (3 years) after obtaining their license.
• 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): Technical paper,
Pamphlet / Book or Monograph, Article in magazine /
Newspaper, Inventions
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.
− Condition in human in which the virus invades the
CD4+ t lymphocytes – type of immune cells the
stimulates killer t-cells, macrophages and b-cells to
make the immune response
• 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.
− Opportunistic infections and malignancy are
conditions that rarely occur in the absence of severe
immunodeficiency. Example is the Pneumocystis
pneumonia or Central Nervous System Lymphoma
can also be detrimental in a person with severe
immunodeficiency.
− CD4 count below 200 cells per μl or CD4
percentage below 14% are considered to have
HIV/AIDS
 BLOOD DETECTION TESTS

− Tuberculosis (TB) – Most common opportunistic

infection and 1st cause of (10-30%) mortality in HIV
infected patients
MODE OF TRANSMISSION
• You can get HIV via: − HAART – Highly Active Anti-Retroviral Therapy are
− Sex without a condom the treatment/medication to manage the virus to delay
− Passed from mother to baby the progression of the infection.
− Sharing injecting equipment ANTI-RETROVIRAL DRUGS
− Contaminated blood transfusions and organ • Nucleoside Reverse Transcriptase inhibitors:
transplants Azidothymidine (Zidovudine)
• You can’t get HIV from: • Non-Nucleoside Transcriptase inhibitors:
− Kissing Viramune (Nevirapine)
− Hugging • Protease inhibitors: Norvir (Ritonavir)
− Sharing food DIFFERENCES: HIV 1 and HIV 2
− Insect bites
− Toilet seats
− Bathing
− Sneezing and coughs
− Sweat
“HIV is manageable and preventable but it is not curable”
PRIMARY PREVENTION
SAFER SEX PRACTICES
− Postponing your sexual – Stay as a virgin
− Do non-penetrative sex – Touching each other, EPIDEMIOLOGY OF HIV WORLDWIDE
mutual masturbation, cuddling, and kissing. − According to the Worldwide Epidemiology on 2022,
− Correct and consistent use of male and female there are 37.7 million people living with HIV/AIDS and
condom and reducing the number of sexual partners there are 680,000 people who have died of HIV
• Five ways to protect yourself related illnesses worldwide.
1. Abstinence
2. Monogamous Relationship
3. Protected Sex
4. Sterile needles
5. New shaving/cutting blades
• You can’t prevent or cure HIV by:
− Washing after sex
− Sex with a virgin
− Pulling out method
− Spells and herbal medicine
− Using the contraceptive pill HIV/AIDS EPIDEMIC TRENDS IN THE PHILIPPINES
▪ Condoms and Pre-exposure Prophylaxis (PrEP) used (January 1984 – March 2021)
correctly and consistently protect you from HIV
transmission during sex.
▪ Prevention is better than cure. Especially when
something has no cure.
HIV TESTING
• Any laboratory procedure done on any individual to
determine the presence or absence of HIV infection
− Presence of antibodies is considered as HIV (+) and − The first case of HIV infection in the Philippines was
absence of antibodies is HIV (-) reported in 1984. Since then, there have been 85,651
• WINDOW PERIOD: refers to the period of time, confirmed HIV cases to the HIV/AIDS and ART
usually lasting from two weeks to six (6) months Registry of the Philippines (HARP).
during which an infected individual will test "negative" PREVALENCE OF HIV IN THE PHILIPPINES
upon HIV testing but can actually transmit the
infection.
• Screening Test (HIV-1 & HIV-2) – ELISA
• Confirmatory Test – WESTERN BLOT TECHNIQUE
• Diagnostic for HIV – 2 (+) ELISA AND 1 (+)
WESTERN BLOT IT IS THE

PREVALENCE OF HIV IN DIFFERENT AGE GROUPS
PREVALENCE OF HIV ACCORDING TO THE MODES
OF TRANSMISSION
REPUBLIC ACT NO. 11166
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.
− 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
− HIV/AIDS are public concerns that have wide ranging
social, political, and economic repercussions.
• 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;
• 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;
− Ex: having sex with homosexual, injecting drugs,
sharing needle equipment, having unprotected sex
with someone with a high-risk behavior
• 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 is confidential and voluntary in nature and
it must be accompanied by a counselling prior to and
after the testing and conducted only with the informed
consent of a person.
• 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 undergoing HIV testing
and the test result itself before the individual is
subjected to the test;
• 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:
(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 – 6 years maximum term
AIDS MEDIUM TERM PLAN (AMTP) – The latest AMTP
covers 2017-2022
• 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) (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:
(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:
(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 • Discrimination in the Workplace: ejection of job
economic, social, medical support for overseas application, termination of employment, or other
workers, regardless of employment status and stage discriminatory policies in hiring, provision of
in the migration process. employment and other related benefit, promotion or
• Care and Support for Affected Families, Intimate assignment of an individual;
Partners, Significant Others and Children of • Discrimination in Learning Institution: refusal of
People Living with HIV. admission, expulsion, segregation, imposition of
• Care and Support Program in Prisons and Others harsher disciplinary actions, or denial of benefits or
Closed-Setting Institutions. All prisons, services of student or a prospective student;
rehabilitation centers, and other closed-setting • Restriction on Travel and Habitation: restrictions
institutions shall have comprehensive STI, HIV and on travel within the Philippines, refusal of lawful entry
AIDS prevention and control program. to Philippine territory, deportation from Philippines, or
• Non-discriminatory HIV and AIDS Services. the quarantine or enforced isolation of travelers is
Ensure the delivery of non-discriminatory HIV and discriminatory. The same standard of protection shall
AIDS services by government and private HIV and be accorded to migrants, visitors, and residents who
AIDS service providers. are not Filipino citizens;
• Protection of HIV Educators, Licensed Social • Restrictions on Shelter: restrictions on housing or
Workers, Health Workers, and Other HIV and AIDS lodging, whether permanent or temporary;
Service Providers from Harassment. Any person • Prohibition on the right to seek an elective or
involved in the provision of HIV and AIDS services, appointive public office;
including peer educators, shall be protected from suit, • Exclusion from Credit and Insurance Services:
arrest or prosecution, and from civil, criminal or exclusion from health, accident or life insurance, or
administrative liability, on the basis of their delivery of credit and loan services, including the extension of
such services in HIV prevention. such loan or insurance facilities of an individual;
• Health Insurance and Similar Health Services. The • Discrimination in Hospitals and Health
PhilHealth shall enforce confidentiality in the provision Institutions: denial of health services, or being
of these packages to PLHIV. No PLHIV shall be charges with a higher fee, on the basis of actual,
denied or deprived of private health insurance under perceived or suspected HIV status is discriminatory
a Health Maintenance Organization (HMO) and act and is prohibited;
private life insurance coverage under a life insurance • Denial of Burial Services: denial of embalming and
company on the basis of the person's HIV status. burial services for a decease person who had HIV and
Furthermore, no person shall be denied of his AIDS or who was known, suspected, or perceived to
insurance claims if he dies of HIV or AIDS under a be HIV-positive;
valid and subsisting life insurance policy. • Bullying in all forms, including name-calling, upon a
CONFIDENTIALITY person based on actual, perceived, or suspected HIV
• The confidentiality and privacy of any individual who status, including bullying in social media and other
has been tested for HIV, has been exposed to HIV, online portals.
has HIV infection or HIV- and AIDSrelated illnesses, PENALTIES
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
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 − Heritable conditions are treatable once immediately
testing. detected but it can lead to morbidity and mortality if
left untreated because the onset of the signs and
symptoms are irreversible.

REPUBLIC ACT NO. 9288

− “AN ACT PROMULGATING A COMPREHENSIVE
POLICY AND A NATIONAL SYSTEM FOR
ENSURING NEWBORN SCREENING” MILESTONES IN THE HISTORY OF NEWBORN
WHAT IS NEWBORN SCREENING? SCREENING IN THE PHILIPPINES
• 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.
− Heritable condition – any condition that can result in
mental retardation, physical deformity or death if left
undetected and untreated which is usually inherited
from the genes of both biological parents of the
newborn.
• 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.
REPUBLIC ACT NO. 9288
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:
1. General Provisions - Sections 1, 2, 3
2. Definition of Terms - Section 4
3. Newborn Screening - Sections 5, 6, 7, 8, 9
4. Implementation - Sections 10, 11, 12, 13, 14, 15, 16
5. Final Provisions - Sections 17, 18, 19
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
− The Government will establish and integrate
sustainable (no period, continuous) NBS as part of
public health delivery system (meaning everyone
must afford)
− Practitioners as front liners/ middleman must know its
obligation:
▪ To discuss the advantages of NBS, significance,
information and others crucial to understanding
and dissemination of the program
− As part of responsible Parenthood, parents must
recognize their responsibilities in promoting child’s life
and health from preventable disorders that can cause
disability and death
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;
− 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.
2 REASONS
1. To ensure that the newborn patient complies fully
with the treatment intervention
2. To know whether there is a progression of the
disease and whether effective treatment has
been given.
• 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
− Confirmatory Center, Newborn Screening Reference
Center, and the central facility within the NIH that is
pass to oversee as far as all the protocols, guidelines,
training, updates, informational brochure content, and
they also provide externa provide external QA
(proficiency testing – sort of accreditation) are
concern, for accuracy (coherence of results)
• 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.
NEWBORN SCREENING
• 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.
• 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
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 − Additional 200 pesos for the hearing test
newborn screening services
− (4%) to the Newborn Screening Centers for human
resource development and equipment maintenance
and upgrading
− (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

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).
• Thyroid gland:
− Butterfly shaped endocrine gland that produces
thyroid hormones like T3, T4
− Responsible for normal development and function of
certain body organs like bones, muscles, teeth and
particularly brain
• 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.
− Adrenal glands sit atop the kidney. It produces
cortisol, aldosterone, androgens,
catecholamines. These hormones regulate the
metabolism, help in the immunity, regulate blood
pressure and maintain sexual characteristics.
• 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.
− If phenylalanine accumulated in the brain, it is
neurotoxic causing mental retardation.
• 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
avoidanceof 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 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.
− G6PD is an enzyme that is present
in all cells but is much valued in RBC. It is needed for
the 1st step in the hexose monophosphate pathway.
The pathway produces NADPH that functions as
electron donor in maintaining glutathione in its
reduced form. The glutathione serves as an
antioxidant that protects the cells against oxidative
damage.
• Other associated disorders to G6PD deficiency are
decreased RBC lifespan and cataract formation.
− Splenomegaly
• 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
and 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.
− Accumulation of galactose
• 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.
REPUBLIC ACT NO. 7719
− “NATIONAL BLOOD SERVICES ACT OF 1994”
• World Blood Donor Day takes place on June 14
each year. The aim is to raise global awareness of
the need for safe blood and blood products for
transfusion and of the critical contribution
voluntary, unpaid blood donors make to national
health systems.
• The day also provides an opportunity to call to action
to governments and national health authorities to
provide adequate resources and put into place
systems and infrastructures to increase the collection
of blood from voluntary, non-remunerated blood
donors
• Of the 118.5 million blood donations collected
globally, 40% of these are collected in high-income
countries, home to 16% of the world’s population.
• An increase of 7.8 million blood donations from
voluntary unpaid donors have been reported from
2013 to 2018. In total, 79 countries collect over 90%
of their blood supply from voluntary unpaid blood
donors; however, 56 countries collect more than 50%
of their blood supply from family/replacement or paid
donors – Pay a person to give you blood
• The Department of Health (DOH) finally realized its
goal of collecting one (1) million blood units from the
total population; two decades after the National Blood
Services Act of 1994 (Republic Act No. 7719) was
signed into law.
• Last December 2017, the country’s goal to obtain the
1% (1 million blood units) blood collection from the
total population was achieved and collected
1,120,408 blood units. This represents a significant
contribution to the global call for a 100% voluntary
blood donation by the World Health Organization.
REPUBLIC ACT NO. 7719
SECTION I. TITLE
• This act shall be known as the “National Blood
Services Act of 1994”
• An act promulgating voluntary blood donation,
providing for an adequate supply of safe blood,
regulating blood banks and providing penalties for
violation thereof.
• Approved in May 5, 1994 by Pres. Fidel V. Ramos
SECTION II. DECLARATION OF POLICIES
• To promote and encourage voluntary blood donation
by the principle that blood donation is a
humanitarian act
• To lay down the legal principle of blood transfusion is
a professional medical service and not a sale of a
commodity
• To provide adequate, safe, affordable and equitable
distribution of supply of blood and blood products
• To inform the public of the voluntary blood donation
to curb hazards caused by the commercial sale of
blood
• To teach the benefits and rationale in the existing
health subjects of the formal education systems
and non-formal education systems
• To mobilize all the sectors of the community to
participate in mechanisms for voluntary and non-profit
collection of blood
• To mandate the DOH to establish and organize a
National Blood Transfusion Service Network –
Can request blood type in other partnered centers
• Assistance to institution promoting voluntary blood
donation providing non-profit blood services
• To require all blood collection units and blood
banks/centers to operate a non-profit basis – Tax
exempted and charitable
• To establish scientific and professional standards
for the operation of blood collection units and blood
bank/centers
• To regulate and ensure the safety of all activities
related to the collection, storage and banking of
blood
− HIV and Malaria – Diseases acquired from blood
transfusion
• Upgrading of blood banks/centers for preventive
services and education
SECTION III. DEFINITIONS
• Blood/Blood Product – Refers to human blood,
processed or unprocessed and includes blood
components, its products and derivatives;
• Blood Bank/Center – A laboratory or institution with
the capability to recruit and screen blood donors,
collect, process, store, transport and issue blood for
transfusion and provide information and/ or education
on blood transfusion transmissible diseases;
• Commercial Blood Bank – A blood bank that exists
for profit;
• Hospital-Based Blood Bank – A blood bank which
is located within the premises of a hospital, and which
can perform compatibility testing of blood/cross
matching;
• Blood Collection Unit – An institution or facility duly
authorized by the Department of Health to recruit and
screen donors and collect blood;
• Voluntary Blood Donor – One who donates blood
on one’s own volition or initiative and without
monetary compensation;
• Department – The Department of Health;
• Blood Transfusion Transmissible Diseases –
Diseases which may be transmitted as a result of
blood transfusion, including AIDS, Hepatitis-B,
Malaria and Syphilis;
• Secretary of Health – The Secretary of Health or any
other person to whom the Secretary delegates the
responsibility of carrying out the provisions of this Act;
and
• Walking Blood Donor – An individual included in the
list of qualified voluntary blood donors referred to in
Section 4, paragraph (e), who is ready to donate
blood when needed in his/her community.
SECTION IV. PROMOTION OF VOLUNTARY BLOOD
DONATION
• In order to ensure adequate supply of human blood,
a voluntary blood donation shall be promoted through
the following:
a. Public Education
− Organized and sustained nationwide public
education campaign by the Department, the
Philippine National Red Cross (PNRC) and the
Philippine Blood Coordinating Council (PBCC),
set aside funds and generate financial support for
all sectors.
b. Promotion in Schools
− Benefits and rationale of voluntary blood donation
shall be included and given emphasis in health
subjects of schools, both public and private, at the
elementary, high school and college levels.
− Required by the DECS in the inclusion of non-
formal education curricula
c. Professional Education
− Continuing medical education, trainings on the
rational use of blood products including merits of
voluntary blood donation
d. Establishment of Blood Services Network
− Blood Centers shall be strategically established in
every province and city nationwide
− The promotion of blood collection in schools,
business enterprises, barangay and military
camps shall be promoted
− By the help of:
▪ Department of Health (DOH)
▪ Philippine Blood Coordinating Council
(PBCC)
▪ Philippine Society of Hematology and Blood
Transfusion (PSHBT)
▪ Philippine Medical Association (PMA)
▪ Philippine Association of Medical
Technologists (PAMET)
▪ Philippine Nurses Association (PNA)
e. Walking Donors
− In areas where there may be inadequate blood
banking facilities, the walking blood donor
concept shall be encouraged and all government
hospitals, rural-health units, health centers and
barangays in these areas shall be required to
keep at all times a list of qualified blood donors
with their specified blood typing.
SECTION V. NATIONAL VOLUNTARY BLOOD
SERVICES PROGRAM
• A program to meet an evolutionary manner, needs for
blood transfusion in all region of the country.
• Funds for this purpose shall be provided by the
government through the following institutions:
− PCSO (P25,000,000.00)
− PAGCOR (P25,000,000.00)
− Duty Free Shop (P20,000,000.00)
− Other contributions from other agencies such as
civic organization
SECTION VI. UPGRADING OF SERVICES AND
FACILITIES
• All blood banks/centers shall provide preventive
health services such as education and counseling on
blood transfusion transmittable diseases.
− Philippine Society of Hematology and Blood
Transfusion (PSHBT)
− Philippine Society of Pathologists (PSP)
• All government hospitals shall be required to establish
voluntary blood donation programs and private
hospitals are encourage to establish the said program
also.
SECTION VII. PHASE-OUT OF COMMERCIAL BLOOD
BANKS
• All commercial blood banks shall be phased-out over
a period of two (2) years after effectivity of this Act.
• Extended to a maximum period of two (2) years by the
Secretary
SECTION VIII. NON-PROFIT OPERATION
• All blood banks/centers shall operate on a non-profit
basis; Provided, that they may collect service fee
not greater than the maximum prescribe by the
Department.
• BLOOD SHALL BE COLLECTED FROM HEALTHY
VOLUNTARY DONORS ONLY!
• While donated blood is free, there are significant
costs associated with collecting, testing, preparing
components, labeling, storing and shipping; recruiting
and educating donors; and quality assurance. As a
result, processing fees are charged to recover costs.
Processing fees for individual blood components vary
considerably.
• The following are acceptable maximum allowable
processing fee for blood/components: Whole blood:
Php 1,500.00; Pack Red Cells: Php 1,100.00; Fresh
Frozen Plasma: Php 700.00; Cryoprecipitate: Php
700.00; and Cryosupernate: Php 700.00. (AO 181 s.
2002).
• Hospitals charge for any additional testing that may
be required, such as the crossmatch, as well as for
the administration of the blood.
SECTION IX. REGULATION OF BLOOD SERVICES
• It shall be unlawful for any person to establish and
operate a blood banks/centers unless it is registered
and issued a license to operate by the Department
• No license shall be granted or renewed by the
Department for the establishment and operation
unless it complies with the standards prescribed by
the Department
• No license shall be granted or renewed by the
Department for the establishment and operation of a
blood bank/center unless it complies with the
standards prescribed by the Department.
• Such blood bank/center shall be under the
management of a licensed and qualified physician
duly authorized by the Department.
SECTION X. IMPORTATION OF BLOOD BANK,
EQUIPMENT, BLOOD BAGS AND REAGENTS
• Equipment, blood bags and reagents used for the
screening and testing donors, collection and
processing and storage of blood shall be imported
tax- and duty-free by the PNRC, blood banks and
hospitals participating actively in the National
Voluntary Blood Services Program.
• This provision shall be implemented by the rules and
regulations to be promulgated by the Department in
consultation and coordination with the Department of
Finance.
SECTION XI. RULES AND REGULATION
• The existing Revised Rules and Regulations
Governing the Collection, Processing and Provision
of Human Blood and the Establishment and
Operation of Blood Banks shall remain in force unless
amended or revised by the Secretary
• Rules and regulations shall be promulgated sixty (60)
days from the approval thereof
• The rules and regulations shall prescribe from time to
time the maximum ceiling for fees for the provision of
blood, including its collection, processing and
storage, professional services and a reasonable
allowance for spoilage.
SECTION XII. PENALTIES
• Any blood bank/center which shall collect charges
and fees greater than the maximum prescribed by the
Department shall have its license suspended or
revoked by the Secretary.
− IMPRISONMENT: not less than one (1) month nor
more than six (6) months
− FINE: not less than Five thousand pesos (P5,000) nor
more than Fifty thousand pesos (P50,000)
• Any person who shall establish and operate a blood
bank without securing any license to operate from the
Department or who fails to comply with the standards
prescribed by the Department referred to in Section 9
− IMPRISONMENT: not less than twelve (12) years and
one (1) day nor more than twenty (20) years
− FINE: not less than Fifty thousand pesos (P50,000)
nor more than Five hundred thousand pesos
(P500,000)
• The Secretary may impose administrative sanctions
but not limited to fines, suspension, or revocation of
license to operate a blood banks/centers and to
recommend the suspension or revocation of the
license to practice the profession when applicable.
• The head of the blood bank and the necessary
personnel under the heads direct supervision found
responsible for dispensing, transfusing and failing
to dispose, within forty-eight (48) hours, blood
which have been proven contaminated with blood
transfusion transmissible diseases shall be
imprisoned for ten (10) years.
SECTION XIII. SEPARABILITY CLAUSE
SECTION XIV. REPEALING CLAUSE
• The Act shall supersede the Republic Act No. 1517
“Blood Bank Act” – The first act prior to R.A. No. 7719
SECTION XV. EFFECTIVITY
• This act shall take effect after fifteen (15) days
following as publication in the Official Gazette or in
two (2) newspapers of general circulation
ADDITIONAL NOTE:
• Administrative Order 2008-0008 is the implementing
rules and regulations pursuant to R.A. 7719
CRITERIA FOR DONOR SELECTION:
• Age: 17-65 years old, ≤16 needs parents’ consent
• Weight: 50 kgs or 110 lbs
• Hemoglobin: ≥ 12.5 g/dL
• Hematocrit: ≥ 38%
• Temperature: Oral temp not to exceed 37.5 C or 99.5
F
• Pulse: 50-100 beats /minute (lower pulse beat is
accepted for athletes)
• Blood Pressure:
− American Association of Blood Banking
(AABB): 180 mmHg –systolic
100 mmHg –diastolic
− Philippines: 90-160 mmHg –systolic
60-100 mmHg –diastolic
• Skin Lesions: Evidence of skin lesions (e.g. multiple
puncture marks) is cause for indefinite deferral
DONOR DEFERRAL
• Permanent/Indefinite Deferral
− High risk history of HIV/AIDS
− Male who have sex with male since 1977
− Intravenous drug abusers either past or present
− Anyone who engaged in sex for money since 1977
− Hemophiliacs
− Confirmed Positive test for HIV/AIDS
− Symptoms of viral hepatitis after age 11
− Donors implicated in a post-transfusion hepatitis
− AIDS case
− Confirmed positives test for hepatitis C antibody
(HCab)
− Confirmed positive test for Human T-cell lymphotropic
virus (HTLV)
− Malignant solid tumors, except for basal cell
carcinoma of the skin and carcinoma insitu of the
cervix
− Hematologic malignancies
− Chemotherapeutic agents administered for
malignancy
− Chronic cardiopulmonary, liver, or renal disease
− Serious abnormal bleeding tendencies
− Those who have taken the drug etretinate (Tegison)
for the treatment of psoriasis (teratogenic)
− History of babesiosis
− History of Chagas’ disease
− Anyone who has ever received clotting factor
concentrate
− Recipient of pituitary derived growth hormone (risk of
transmitting Creutzfeld-jacob disease)
− Recipient of cornea/dura mater transplant (risk of
transmitting Creutzfeld-jacob disease)
− Anyone who have taken insulin from cows (risk of
transmitting Mad cow disease)
• Temporary Deferral
− Active disease under treatment such as cold, flu,
tuberculosis, syphilis, infections, curable disease of
the: heart, lung, kidney, liver and gastrointestinal
tract; treatment with antibiotics
• Three Years Deferral
− Immigrant or refugee coming from an area considered
endemic for malaria, three years after departure, or
those who have had a diagnosis of malaria, three
years after becoming asymptomatic
• One Year Deferral
− After hepatitis B immune globulin administration
− After therapeutic rabies vaccination
− Rape victims
− Health care workers with percutaneous exposure to
blood or body fluids
− Close contact to persons with viral hepatitis in the last
12 months
− Tattoo
− Sexual contact with a prostitute or other persons in
high risk group for HIV/AIDS
− Incarceration in jail for more than 72 consecutive
hours
− Transfusion of blood components
− Transplant such as bone marrow or organ/tissue,
bone or skin graft.
− Had accidental needle stick injury
− History of syphilis or gonorrhea
− Leishmania risk (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
• Three Months Deferral
− Typhoid infection
• Two Months Deferral
− Recent blood donation
− 56 days for allogenic donation
− Philippines: 12 weeks or three months
• Six Weeks Deferral
− Following a delivery of a baby
− Philippines: 9 months after childbirth
• One Month Deferral
− German measles(rubella) vaccination
− After cessation of the drug isotretinoin (Accutane) for
acne treatment
− After cessation of the drug finasteride (Proscar) for
the treatment of benign prostatic hyperplasia.
• Two Weeks Deferral
− After vaccination with oral polio, measles(rubeola),
mumps or yellow fever
− After immune reaction to smallpox vaccination
• 48 Hours Deferral
− Whole blood donation deferred after hemapheresis
• 12-24 Hours
− After alcohol intake
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
of donor selection is to assess the suitability of an
individual to be a blood donor. This is to ensure that
blood donation is safe for the donor and the blood
products derived from this donation are safe for the
recipients.
• As COVID-19 continuously affects the world, one of
the breakthrough events is the availability of COVID-
19 vaccines. As the Philippines implements the “The
National Deployment and Vaccination Plan for
COVID-19 Vaccines”, the National Voluntary Blood
Services Program (NVBSP) has taken into account
the need to update the existing guidelines in the
timing of blood donation especially for blood donors
who received vaccination against COVID-19.
• The NVBSP has recommended to update the list of
vaccines with the following deferral period of blood
donation for individuals who have received a
vaccination against COVID-19:
REPUBLIC ACT NO. 4688
− “CLINICAL LABORATORY ACT”
• An act regulating the operation and maintenance of
clinical laboratories and requiring the registration of
the same with the Department of Health, providing
penalty for the violation thereof, and for other
purposes.
• Approved on June 18, 1966
• Signed by President Ferdinand E. Marcos
• This act promulgates the rules and regulation to the
following reasons:
− To protect
− To promote
− Ensures the availability of clinical laboratories 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:
Administrative Order No. 2021-0037
− NEW RULES AND REGULATIONS GOVERNING
THE REGULATION OF CLINICAL LABORATORIES
IN THE PHILIPPINES
ABBREVIATIONS
• DOH-LTO: Department of Health - License to
Operate
• DOH-PTC: Department of Health - Permit to
Construct
• HFSRB: Health Facilities and Services and
Regulatory Bureau
• CHD-RLED: Center for Health Development-
Regulation, Licensing and Enforcement Division
• OLRS: Online Licensing and Regulatory System
• OSSOLS: One-Stop Shop Online Licensing System
RATIONALE, OBJECTIVE AND SCOPE OF
APPLICATION
Rationale
• To align the laboratory procedures with the
requirements of AO 2020-0047 titled “Rules and
Regulations Governing the Licensure of Primary Care
Facilities in thePhilippines.”
• To revise and update the minimum standards and
technical requirements for licensing clinical
laboratories in the Philippines aligned with the main
objective of Republic Act No. 11223 or the Universal
Health Care Act which is to guarantee access to
quality and affordable health products, devices,
facilities and services
Objective
• To ensure accountability of the laboratory on
generation of accurate, precise and reliable
laboratory results in a timely manner through
continuous compliance
Scope
• Shall apply to all individuals, agencies, partnerships
or corporations, whether private or government-
owned, involved in the application for DOH license to
operate and those in the operation of diagnostic
clinical laboratories in the Philippines
DEFINITION OF TERMS
• Clinical laboratory – a facility that is involved in the
pre-analytical, analytical, and post-analytical
procedures, where tests are done on specimens from
the human body to obtain information about the health
status of a patient for the prevention, diagnosis and
treatment of diseases. These tests include, but are
not limited the following disciplines:
− Anatomic pathology
− Clinical chemistry
− Clinical microscopy
− Endocrinology
− Hematology
− Immunology and Serology
− Microbiology
− Molecular and Nuclear diagnostics
− Molecular biology
− Cytogenetics
• Applicant — refers to any natural juridical person,
government instrumentalities/agencies, partnership,
corporation or agency seeking a license to operate and
maintain a clinical laboratory.
• Assessment Tool — the checklist which prescribes
the minimum standards and requirements for
licensure of clinical laboratory.
• Department of Health - License to Operate (DOH-
LTO) — a formal authorization issued by the DOH to
an individual, partnership, corporation, association or
any government agency/unit seeking to perform
laboratory tests in compliance with the requirements
prescribed in this order.
• Department of Health - Permit to Construct (DOH-
PTC) — a permit issued by DOH through HFSRB or
Center for Health Development-Regulation, Licensing
and Enforcement Division (CHD-RLED) to an
applicant who will establish and operate a hospital or
other health facility, upon compliance with required
documents prior to the actual construction of the said
facility. It is also required for:
− Hospitals and other health facilities with substantial
alteration, expansion, renovation
− Increase in the number of beds
− Transfer of site
− Additional services (add-ons) beyond their service
capability
• External Quality Assessment Program (EQAP) —
a program where participating CL are given unknown
samples for analysis. The quality of performance of
the CL shall be assessed through the closeness of its
results to the pre-determined value or reference value
generated by the participating CL through peer group
analysis.
• Initial Application — refer to applications by newly
constructed health facilities, or those with changes in
the circumstances of the facility, such as, but not
limited to, change of ownership, transfer of site,
increase in beds or for additional services beyond
their service capability and major alterations or
renovations.
• Mobile Clinical Laboratory (MCL) — a laboratory
testing unit capable of performing limited CL
diagnostic procedures. It moves from one testing site
to another, and it has a DOH-licensed CL as its main
laboratory.
• National External Quality Assessment Scheme
(NEQAS) — an EQAP activity conducted by the
National Reference Laboratories to assess the quality
ofperformance 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.

• Physician’s Office Laboratory (POL) — refers to a
doctor’s office/clinic wherein CL examinations are
performed for the purpose of monitoring the doctor’s
patients only, wherein no official results shall be
issued. In this Order, POL within the premises of a
DOH-regulated facility shall be under the supervision
of the CL.
• Point of Care Testing (POCT) — refers to diagnostic
testing done at or near the site of patient care rather
than in the CL. It may be in the emergency room,
operating suites, wards, and ambulances.
• Satellite Clinical Laboratory (SCL) — refers to an
extension of the main CL located within the facility’s
compound or premises. It shall have the same service
capability as the main laboratory.
• Referral Tests — refers to CL tests that are either
sent out or outsourced to other DOH-licensed CL with
the same or higher service capability.
GENERAL GUIDELINES
• All CL shall secure DOH-LTO prior to its operation
and must comply with the minimum regulatory
standards and requirements at all times.
• The DOH-LTO shall be secured from the DOH
regulatory office in accordance with DOH
guidelines.
• Only DOH-licensed institution-based CL may have a
SCL which shall be located within the premises of
the regulated health facility.
• A DOH-licensed CL may have MCL services,
provided, they adhere to the standard testing
protocols.
• The DOH-licensed CL shall not perform any
examinations or testing beyond its authorized
service capability. However, it may be allowed to
offer laboratory services other than the respective
stipulated minimum services, such as but not limited
to, MCL, SCL, confirmatory testing for Glucose-6-
Phosphate Dehydrogenase Deficiency, and Rapid
HIV Diagnostic Algorithm (rHIVda), provided that the
additional services have been approved and
indicated as add-on services in the DOH-LTO of the
CL.
• Unit/Section of health facilities performing diagnostic
CL tests such as, but not limited to, arterial blood gas
and/or Radioimmunoassay for thyroid function tests
and Prostate Specific Antigen 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 Organizations/Accredited
Integrated Professional Organizations of the
Professional Regulation Commission. The head of
laboratory shall ensure the optimal overall operations
and maintenance of the CL and if applicable, of its
SCL and MCL.
• There shall be an adequate number of competent
personnel assigned in the different services provided
by the DOH-licensed CL, which includes the MCL,
SCL, remote collection activities, if applicable.
• CLs that are operated and maintained exclusively for
research and teaching purposes shall be required to
register with the DOH-HFSRB.
• The DOH designated NRL shall be covered by the
license of the CL of the hospital where they are
affiliated with. Independent NRLs, or those
designated by DOH but are not affiliated with any
DOH-regulated health facility, shall secure a DOH-
LTO from HFSRB.
• All CLs shall make their prices for laboratory services
accessible to the public as mandated by the UHC law
and related DOH issuances.
• At the Central Office, the Director IV, or in his/her
absence or unavailability or when delegated, the
Director III of HFSRB, shall approve the issuance of
the DOH-LTO of the CL.
• At the CHD, the Director IV, shall approve the
issuance of the DOH-LTO of the CL.
• In the advent of new technologies or diagnostic
platforms that shall affect the current licensing
standards for CL, Department Circulars shall be
issued, as needed, as supplements to this Order.
• The CL shall be compliant with the prescribed
standards and requirements, Assessment Tool for
Licensing Clinical Laboratories and other relevant
laws and issuances. These standards shall also apply
to MCL and SCL.
• The DOH-LTO may be revoked, suspended or
modified in full or in part for any false statement by the
applicant, or as shown by the record of inspection or
for a violation of, or failure to comply with any of the
terms and conditions and provisions of these rules
and regulations.
SPECIFIC GUIDELINES
1. Classification by Ownership
a. Government: operated and maintained, partially or
wholly, by the national government, a local
government unit (provincial, city or municipal), any
other political unit or any department, division, board
or agency.
b. Private: privately owned, established, and operated
with funds through donation, principal, investment or
other means, by any individual, corporation,
association or organization.
2. Classification by Institutional Character
a. Institution-based: a laboratory located within the
premises and operates as part of a DOH licensed
health facility.
b. Non-institution based: a laboratory that operates
independently and is not attached to any DOH
licensed health facility.
3. Classification by Function
a. Clinical Pathology: deals with the chemical and
cellular analyses of blood and other body fluids
(includes, but not limited to, clinical chemistry, clinical
microscopy, toxicology, therapeutic drug monitoring,
immunology and serology, hematology and
coagulation), identification and examination of
microbes and parasites
(bacteriology/parasitology/mycology/virology)
b. Anatomic Pathology: provides processing and
examination of surgical specimens as to physical
appearance and microscopic structures of tissues
such as, but not limited to, surgical pathology,
cytopathology, immunohistochemistry techniques,
autopsies and forensic pathologies.
c. Molecular Pathology: deals with the analysis of
certain genes, proteins and other molecules in
samples from organs, tissues of bodily fluids in order
to diagnose disease/ and or to guide the prevention
 and treatment of disease based on the principles,
techniques and tools of molecular biology as they are
applied to diagnostic medicine in the laboratory.
4. Classification by Service Capability
a. Clinical Laboratory for Clinical and Anatomic
Pathology
b. Clinical Laboratory for Anatomic Pathology only
provides services for any of the following, but not
limited to cytology and histopathology.
c. Clinical Laboratory for Molecular Pathology only —
provides services for genetics,
immuno/hematopathology and infectious disease.
COVID-19 testing laboratories shall be covered by
another Order
PROCEDURAL GUIDELINES
DOH Permit to Construct (DOH-PTC)
• Completely filled out application form for
(downloadable at www.hfsrb.doh.gov.ph), whether
manual or online, shall be submitted to the DOH
regulatory offices
• For construction of new CL and for renovation or
expansion of existing CL, including change in
ownership and transfer of location
Certificate of Registration (COR)
• Required for research and teaching laboratories
License to Operate (LTO)
• Applicant should submit an accomplished application
form to HFSRB/CHD-RLED in accordance with the
current DOH guidelines, whether manual or through
the Online Licensing and Regulatory System (OLRS)
• The DOH-LTO is non-transferable and a new
application for DOH-LTO shall be required in case of
change of ownership or transfer of location.
• Different branch(es) of a CL, even if owned by the
same entity shall secure separate DOH-LTO
• The DOH-LTO shall be placed in an area that can be
readily seen by the public, at all times
• For institution-based CL, the One-Stop Shop (OSS)
Licensing System should be followed
Validity
• The DOH-LTO is valid for one (1) year
• COR for CL that is operated and maintained
exclusively for research and teaching purposes shall
be required to register with the DOH-HFSRB every
three (3) years
Fees
• All fees shall follow the prescribed fees by the DOH.
All fees/checks shall be paid to the order of DOH
Central Office/ CHD Cashier, whichever is applicable
in person, through postal money order or online
payments approved by the DOH
Monitoring
• Authorized representatives from the HFSRB/CHD-
RLED in accordance with the current DOH guidelines,
may conduct unannounced on-site visits of licensed
CL and registered research and teaching laboratories
to monitor and document the continuous compliance
of the CL to the set standards
• CL that are operated and maintained exclusively for
research and teaching purposes shall not issue
official results for diagnostic purposes
ROLES AND RESPONSIBILITIES
Health Facilities and Services and Regulatory Bureau
(HFSRB)
• Set standards for the regulation of CL and strictly
enforce the provisions of this Order.
• Disseminate regulatory policies, standards and forms
for information and guidelines of the DOH-CHDs.
• Provide consultation and technical assistance to
stakeholders, including regulatory officers from the
DOH CHDs in line with the regulation of CL.
• Respond promptly to complaints relative to the
operation of CL under its jurisdiction
Center for Health Development — Regulatory,
Licensing, and Enforcement Division (CHD-RLED)
• Strictly enforce the provisions of this Order.
• Submit quarterly report on Suspension/Revocation/
Cease and Desist Order issued on CL not later than
the 15th day of the following month after the covered
quarter.
• Provide consultation and technical assistance to
stakeholders in line with the regulation of CL.
• Respond promptly to complaints relative to the
operation of CL under its jurisdiction.
National Reference Laboratories (NRL)
• Provide laboratory reference/referral services for
confirmatory testing.
• Train laboratory personnel and recognize other
training institutions.
• Maintain the National External Quality Assessment
Scheme (NEQAS).
• Perform technical evaluation of reagents and
diagnostic kits.
DOH-Licensed Clinical Laboratories
• Continuously comply with the rules and regulations,
licensing standards and requirements for CL, as
provided in this Order and related issuances.
• Participate in EQAP that may be administered by a
designated NRL or other local and international
EQAP approved by the DOH, surveys and other
activities that will be required from them by the DOH.
• In times of Pandemic of Public Health Event, be
mandated to submit timely reports and data.
VIOLATIONS, SANCTIONS AND APPEAL
• A CL shall be sanctioned and penalized by the
HFSRB/CHD Director upon violation of any of these
guidelines and its related issuances and laws, or upon
committal (commission/omission) of prohibited acts
by the persons owning or operating the CL, and/or the
persons under their authority.
• For non-institution-based CL that are not under the
OSSOLS, the following are the penalties and
sanctions that shall be imposed for the commission of
any of the violations in this Order and other relevant
issuances:
− 1st offense: Stern warning
− 2nd offense: Thirty thousand pesos (Php 30,000.00)
− 3rd offense: Fifty thousand pesos (Php 50,000.00)
− 4th offense: Revocation of DOH-LTO
• Any person who operates a CL without securing the
necessary DOH-PTC and corresponding DOH-LTO
shall be issued a Cease-and-Desist Order (CDO) and
shall pay the administrative penalty of Fifty thousand
pesos (Php50,000.00).
• In case of complaints, the CL, upon receipt of such by
HFSRB/CHD-RLED shall be given due process
wherein an investigation shall be conducted and the
appropriate sanctions for its violation/s. A 60-day
preventive suspension may be given to the CL during
the investigation depending on the seriousness of the
violation.
• May appeal to the Head of the Health Regulation
Team (HRT). The decision of the Head of the HRT, if
still contested may be brought on a final appeal to the
Secretary of Health, whose decision shall be final and
executory.
• CL with revoked licenses can only re-apply after one
year from the date of LTO revocation.
• Any person authorized or licensed to conduct clinical
laboratory tests, who issues false or fraudulent
laboratory test results knowingly, willfully or through
gross negligence shall not be allowed to own,
manage, operate, or be an analyst of any DOH-
licensed CL.
LICENSING STANDARDS FOR CLINICAL
LABORATORY
Physical Plant
• The CL shall conform to all applicable local and
national regulations for the construction, renovation,
maintenance and repair of CL.
• The laboratory shall conform to the required space for
the conduct of its activities. Personnel, fixtures,
equipment, sink, etc. shall also be considered.
• There shall be well-ventilated, lighted, clean, safe and
functional areas based on the services provided.
• There shall be a program of proper maintenance and
monitoring of physical plant and facilities.
• There shall be policy guidelines on laboratory
biosafety and biosecurity which includes risk
assessment that will serve as the basis of biosafety
level required for the specific CL.
• There shall be an area for confirmatory testing for
Rapid HIV Diagnostic Algorithm and Glucose-6-
Phosphate Dehydrogenase (G6PD) Deficiency which
may be a section, unit, or division integrated in a DOH
licensed CL, if applicable.
PERSONNEL
Head of The Laboratory (HOL)
• Shall be a competent and experienced professional,
with a specialized skill set related to and proportionate
to the laboratory category, to ensure that the
laboratory runs efficiently
• Essentially responsible for the operation of the entire
laboratory, its personnel, functions, and data, all of
which shall meet the quality assurance criteria and
regulatory requirements
• Shall oversee the operation of the CL and have
administrative and technical supervision of the
activities including the mobile clinical laboratories
(MCL), remote collection activities, and point of care
testing (POCT), if applicable.
• Shall supervise the staff in accordance with the
standards set by the Philippine Society of
Pathologists
• Shall visit once a month and at least twice a week of
supervisory calls and/or videoconferencing or at least
once a week physical visit. For hospital-based DOH
licensed CL, it shall be once a week physical visit. The
visits shall have to be well documented.
• For Geographically Isolated and Disadvantaged
Areas (GIDAs) with no clinical pathologists, as
certified by the Philippine Society of Pathologists,
board certified Anatomic Pathologists or Physicians
with complete training in Clinical Laboratory Medicine,
Quality Assurance and Laboratory Management, may
head one primary DOH licensed CL.
Registered Medical Technologist (RMT)
• There shall be an adequate number of full-time RMTs
conduct the laboratory procedures, including those
assigned in MCL. The number of staff shall depend
on the workload and the services being provided.
• There shall be staff development and continuing
education program at all levels of organization to
upgrade the knowledge, attitude and skills of staff.
• There shall be a designated Biosafety and Biosecurity
Officer in-charge primarily of the risk assessment of
the DOH licensed CL.
Support Staff
• There shall be an adequate number of support staff
such as, but not limited to laboratory technician,
laboratory aide, encoders, and receptionists when
applicable.
POCT Coordinator — if applicable
• A senior staff from the CL shall be designated as a
POCT coordinator who shall have the following
functions, but not limited to:
− Recommends procedures that will ensure the quality
of results of POCT in consultation with the
pathologist.
− Ensures that POCT machines/device and kits are
properly maintained.
− Supervises the operators of POCT device/machine.
− Ensures that the operators have appropriate trainings
and checks the competency of the operators
regularly.
− Ensures that quality control (QC) is implemented and
reviews POCT QC results periodically, depending on
the number of tests.
POCT Operator — if applicable
• The designated operator of the POCT
device/machine and testing kits shall have the
following functions, but not limited to:
− Ensures accurate results of POCT.
− Ensure that POCT machines/device and kits are
properly maintained and stored.
− Run tests on quality control at least once each day or
as recommended by the manufacturer.
− Initially, implements quality assurance program or
contact the manufacturer’s application specialist for
assistance, when a POCT machine/device is not
 properly functioning, or the control sample is in out-
of-control range.
− Reports to the supervising CL any untoward incidents
or problems
MCL Personnel
• MCL shall has its own set of personnel, which
includes the following but not limited to:
− Registered Medical Technologist — number will
depend on the anticipated workload.
− Support staff such as, but not limited to, driver and
laboratory technician.
EQUIPMENT/INSTRUMENTS/REAGENTS/GLASSWA
ES/SUPPLIES
There shall be:
• Available and operational
equipment/machines/devices to provide the
laboratory examination that the laboratory is licensed
for.
• A calibration, preventive maintenance and repair
program for every
equipment/machines/instruments/device in the DOH
licensed CL.
• A contingency plan in case of
equipment/machines/devices breakdown and
malfunction.
• Adequate available reagents, glassware and supplies
for the laboratory examinations.
• An inventory control of the reagents, glassware and
supplies, reagents, glassware and supplies shall be
properly stored under the required conditions.
• Machines/devices, reagents and test kits that are
used in the CL and MCL as well as POCT shall be
approved by the Philippine Food and Drug
Administration and validated by the proper
government institutions (e.g. National Reference
Laboratory).
• The MCL shall have its own set of functional, and
operational equipment, as well as its own set of
supplies.
Service Delivery
• All CL shall ensure that the service being delivered to
patients must comply with the standards and other
related relevant issuances.
• Mobile Clinical Laboratory: collection site/area for
MCL shall be located within the same region, at a
maximum of one hundred (100) kilometer radius, from
the address of the DOH licensed CL.
• Aside from specimen collection for different tests
within the service capability of the main CL, the MCL
shall be allowed to perform the following on-site tests
which shall be declared in the LTO of the main CL:
− Urinalysis
− Fecalysis
− Pregnancy Test (lateral flow)
− Basic Serologic Test using Rapid Test Kits —
Dengue, Screening of Hepatitis B, RPR/Syphilis Test,
and HIV
• Specimen collected for another test, not mentioned
above should be properly handled and transported.
Serum blood samples for chemistry testing must be
separated within four (4) hours from the time of
collection.
INFORMATION MANAGEMENT
Administrative Policies and Procedures
• The CL shall have written policies and procedures for
the provision of laboratory services, the operation and
maintenance of the CL, which includes satellite
laboratories, MCL and POCT, and shall include the
accountabilities of every personnel working in the
laboratory.
• There shall be documented technical procedures for
services provided in each section of the laboratory,
including MCL and POCT, which will ensure the
quality of laboratory results.
• There shall be a risk assessment for every section in
the CL.
Communication and Records Management
• The CL shall maintain and ensure the confidentiality
of all records.
• There shall be procedures for the receipt and
performance of routine and STAT requests for
laboratory examinations.
• There shall be procedures for the reporting of results
of routine and STAT laboratory examinations,
including critical values that would impact on patient
care.
• All results shall be released in accordance with DOH
guidelines.
• All laboratory reports on various examinations of
specimens shall bear the name, PRC registration
number, and original signature of the registered
medical technologist(s) who performed the laboratory
examinations, and the pathologist who shall be
accountable for the reliability of the results.
• There shall be a policy guideline on the use of digital
signature. The use of digital signature for laboratory
results shall be permitted only if properly
authenticated by the Department of Information and
Communication Philippine National Public
Infrastructure. The use of digital signature shall also
be in accordance with the provisions of the E-
Commerce Law.
• There shall be procedures for the reporting of
workload, quality control, inventory control, work
schedule and assignments.
• There shall be procedures for the reporting and
analysis of incidents, adverse events, and in handling
complaints.
• The retention of laboratory documents, records,
slides and specimens shall be in accordance to the
standards promulgated by the DOH or by competent
authorities for such purposes.
• The operating hours of the CL shall be known to its
clients.
• The CL which supervises the POCT shall have a
master list of the following, but not limited to a. name
and designation of operators, and b. POCT machines,
instruments and kits.
QUALITY IMPROVEMENT
• There shall be an Internal Quality Assurance Program
which shall include:
− An Internal Quality Control Program for technical
procedures.
− An Internal Quality Assurance Program for inputs,
processes and outputs.
− A Continuous Quality Improvement Program covering
all aspects of laboratory performance.
− The CL shall participate in External Quality
Assessment Program (EQAP) that may be
administered by a designated NRL or other local and
international EQAP approved by the DOH.
REFERRAL OF LABORATORY EXAMINATIONS
• The referral laboratory must be a DOH-licensed CL.
They shall have a Memorandum of Agreement (MOA)
with the referring CL and shall be responsible for the
collection, transport and processing of specimens,
and releasing of results.
• A separate MOA is required when referred tests, The DOH-LTO will be revoked immediately after
which are not within the service capability of the CL, commission of the following prohibited acts and violations:
unless the referral is part of the contingency plan. • Permitting unauthorized or unregistered personnel to
• A MOA prescribing the accountabilities of each party, perform technical procedures and access to
shall be secured when laboratory examinations are laboratory records/data;
referred to and provided by another DOH-licensed • Lending or using the name of the DOH-licensed CL or
CL. the head of the laboratory or medical technologist to
• Referral of examinations to other DOH-licensed CL an unlicensed CL;
are only permitted in the following circumstances: • Unauthorized use of the name and signature of the
− If the laboratory test to be sent out is not part of the pathologist and RMT to secure LTO;
service capability expected for the particular category • Issuance of fraudulent laboratory results, or tests not
of the referring laboratory. actually done or inaccurate results;
− If referral of laboratory test is part of the contingency • Change in the ownership, location, and head of the
plan, in cases of equipment breakdown, of the laboratory or laboratory personnel without informing
referring CL, this shall be for a certain limited period the HFSRB/CHD-RLED; and,
of time only, which shall not last for more than 3 • Any material false statement in the application of
months. This shall be properly documented. LTO.
ENVIRONMENTAL MANAGEMENT
• There shall be a program of proper maintenance and
monitoring of physical facilities.
• There shall be procedures for proper disposal of
infectious wastes and toxic and hazardous
substances in accordance with RA 6969, also known
as “Toxic Substances and Hazardous and Nuclear
Wastes Control Act of 1990” and other related policy
guidelines and/or issuances.
• There shall be a “No smoking policy” and that the
same shall be strictly enforced.
• There shall be a contingency plan in case of accidents
and emergencies.
• There shall be a policy for biosafety and biosecurity.
• There shall be policy guidelines on infection
prevention and control
PROHIBITED ACTS IN THE OPERATIONS OF
CLINICAL LABORATORIES
The Clinical Laboratory (CL) may be sanctioned or
penalized upon commission of the following prohibited
acts and violations:
• Refusal to allow HFSRB/CHD-RLED authorized
personnel to conduct inspection or monitoring visits of
the clinical laboratory at any appropriate time;
• Refusal or nonparticipation of any CL in an External
Quality Assessment Program (EQAP) provided by a
designated NRL or other local and international
EQAP approved by the DOH;
• Absence of action to improve the unsatisfactory or
failed EQAP administered by a designated NRL or
other local and international EQAP approved by the
DOH;
• Demonstrating incompetence or making consistent
errors in the performance of CL examinations and
procedures;
• Deviation from the standard test procedures including
use of expired reagents;
• Issuance of a laboratory report without the approval
of the head of the laboratory;
• Transferring of laboratory results done by another
laboratory to the result form of the referring
laboratory;
• 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.
• Violation of provisions in the Republic Act No. 10173
or the Data Privacy Act of 2021.