REPUBLIC ACT NO.

10912 • Improves productivity with the help of motivated and

skilled employees
“Continuing Professional Development Act of 2016” • Delivers a deeper understanding of what it means to
CONTINUING PROFESSIONAL DEVELOPMENT be a professional, along with a greater appreciation of
• Continuing means without break in continuity the implications and impacts of your work.
• Professional means person’s work requiring special PROFESSIONAL’S CAREER AND PRACTICE OF
training PROFESSIONS
• Development means a process of growing or • Ensures that we maintain and enhance the
changing and becoming more advanced knowledge and skills we need to deliver a
• Process of honing the knowledge, skills and attitude professional service to your customers, clients and
of a professional the community.
− “EDUCATION IS NOT THE LEARNING OF FACTS, • Helps professionals continue to make a meaningful
BUT THE TRAINING OF THE MIND TO THINK.” contribution to the society and nation for economic
REPUBLIC ACT 10912 growth.
• Otherwise known as the “Continuing Professional • Helps advance the body of knowledge and
Development (CPD) Act of 2016”, is an act which technology within the profession.
requires CPD as the mandatory requirement for the EMPLOYER
renewal of Professional Identification Card. • Endorses a learning culture in the organization
• Fusion of Senate Bill No. 2581 and House Bill No. • Enhances the reputation of the company among
6423 = CPD Law of 2016 prospective employees and clients
• Senate Bill No. 2581, which was approved by the • Increases employee retention
Senate on August 3, 2015, was adopted as an PUBLIC AND NATION
amendment to House Bill No. 6423 by the House of • Promotes and upgrades the practice of professions in
Representatives on May 23, 2016. the country
• The CPD Act Lapsed into Law on July 21, 2016 and • Ensuring their contribution in uplifting the general
it took effect on August 16, 2016. welfare, economic growth and development of the
• Approved: July 21, 2016 by President Benigno S. nation
Aquino III STRENGTHENING THE CPD PROGRAMS
DEFINITION OF TERMS There shall be formulated and implemented CPD
• AIPO/APO refers to the Accredited Integrated Programs in each of the regulated professions in order to:
Professional Organization or the Accredited 1. Enhance and upgrade the competencies and
Professional Organization in a given profession. qualifications of professionals for the practice of their
• ASEAN Qualifications Reference Framework professions pursuant to the PQF, the AQRF and the
(AQRF) refers to the device that enables ASEAN MRAs;
comparisons of qualifications across ASEAN Member 2. Ensure national and international alignment of
States. competencies and qualifications of professionals
• ASEAN Mutual Recognition Arrangement (ASEAN through career progression mechanism leading to
MRA) refers to a regional arrangement entered into specialization/ sub-specialization
by the ASEAN Member States, predicated on the 3. Ensure the development of quality assured
mutual recognition of qualifications, requirements mechanisms for the validation, accreditation and
met, licenses and certificates granted, experience recognition of formal, non-formal and informal
gained by professionals, in order to enhance mobility learning outcomes, including professional work
of professional services within the region. experiences and prior learning
• Philippine Qualifications Framework (PQF) refers 4. Respond to national, regional and international labor
to the quality assured national system for the market and industry needs.
development, recognition and award of qualifications 5. Recognize and ensure the contributions of
at defined levels, based on standards of knowledge, professionals in uplifting the general welfare,
skills and values, acquired in different ways and economic growth and development of the nation.
methods by learners and workers. NATURE OF CPD PROGRAMS
DECLARATION OF POLICY The CPD Programs consist of activities that range from
• It is hereby declared the policy of the State to promote structured to non-structured activities, which have
and upgrade the practice of professions in the learning processes and outcomes. These include, but not
country. Towards this end, the State shall institute limited to the following:
measures that will continuously improve the 1. FORMAL LEARNING
competence of the professionals in accordance with • Doctoral Degree, Master’s Degree, Post-graduate
the international standards of practice, thereby, Diploma/Certificate/Diplomate/Fellowship Program
ensuring their contribution in uplifting the general 2. NON-FORMAL LEARNING
welfare, economic growth and development of the • Professional activities: conference,
nation. seminar/workshop/colloquium, in-service training,
PROFESSIONALS webinar, tutorial, study tour/plant visit, exhibit, poster
• Improves the competence of the professionals in presentation, program/module development,
accordance with the international standards of publication, invention, consultancy, and
practice; ensures your capabilities keep pace with the recognition/award/title
current standards meaning it ensures that you and • Volunteer engagement: medical mission/outreach
your knowledge stay relevant and up to date. program, environmental initiative, livelihood program,
• As our skills and knowledge matures (indication of disaster/calamity assistance, service to worthy
confidence) projects and CSR projects
• Opens doors to excellent future employment 3. INFORMAL LEARNING
opportunities
• Reading of books, magazine journals, and the like • Monitor and evaluate the implementation of the CPD
that will develop leadership, management, and other Programs;
skills • Assess and/or upgrade the criteria for accreditation of
4. ONLINE LEARNING ACTIVITIES CPD Providers and their CPD Programs on a regular
5. PROFESSIONAL WORK EXPERIENCE basis;
• Reading of books, magazine, journals, and the like on • Develop mechanisms for the validation, accreditation
how to improve knowledge and skills in the field of and recognition of self-directed learning,
professional practice prior/informal learning, online learning, and other
• Providing professional consultancy services to clients learning processes through professional work
POWER, FUNCTIONS AND RESPONSIBILITIES OF experience;
THE PRC AND THE PROFESSIONAL REGULATORY • Conduct researches, studies and benchmarking for
BOARD international alignment of the CPD Programs;
1. Organize CPD Council for each of the regulated • Issue operational guidelines, with the approval of the
professions and promulgate guidelines for their PRC and the PRB concerned; and
operation • Perform such other functions related or incidental to
2. Review existing and new CPD Programs for all the the implementation of the CPD.
regulated professions CPD PROGRAM IMPLEMENTATION AND
3. Formulate, issue and promulgate guidelines and MONITORING
procedures for the implementation of the CPD • The CPD is hereby made as a mandatory
Programs requirement in the renewal of the PICs of all
4. Coordinate with academe, concerned government registered and licensed professionals under the
agencies and other stakeholders in the regulation of the PRC.
implementation of the CPD Programs and other • All duly validated and recognized CPD credit units
measures earned by a professional shall be accumulated and
5. Coordinate with concerned government agencies in transferred in accordance with the Pathways and
the development of mechanisms and guidelines, in Equivalencies of the PQF.
the grant and transfer of credit units earned from all • The PRC and the PRBs, in consultation with the
learning processes and activities AIPO/APO, the Civil Service Commission (CSC),
CPD COUNCIL other concerned government agencies and industry
• The chairperson of the CPD Council shall be the stakeholders, shall formulate and implement a Career
member of the PRB so chosen by the PRB concerned Progression and Specialization Program for every
to sit in the CPD Council. profession. The Career Progression and
• First member: president or officer of the AIPO/APO Specialization Program shall form part of the CPD.
duly authorized by its Board of Governors/Trustees. • All concerned government agencies and private firms
− Absence of the AIPO/APO: the PRB concerned shall and organizations employing professionals shall
submit within ten (10) working days from notification include the CPD as part of their human resource
of such absence, a list of three (3) recommendees development plan and program.
from the national professional organizations. The FINAL PROVISIONS
PRC shall designate the first member within thirty (30) • The funding requirement herein mentioned shall be
days from receipt of the list. used for the regular operations of the CPD Councils,
• Second member: president or officer of the national including the monitoring of the conduct of the CPD
organization of deans or department chairpersons of Programs.
schools, colleges or universities offering the course • The PRC shall review and approve the proposed
requiring the licensure examination. budget for each CPD Council, taking into
− Absence of such organization: the PRB concerned consideration the reasonable expenses that will be
shall submit, within ten (10) working days from incurred for travel, honorarium/allowances, and per
notification of such absence, a list of three (3) diems, when attending official CPD Council meetings
recommendees from the academe. The PRC shall or performing other related functions assigned to
designate the second member within twenty (20) them.
working days from receipt of the list. • The PRC and the PRBs, in consultation with the
• The term of office of the chairperson of the CPD AIPO/APO and other stakeholders, shall promulgate
Council shall be coterminous with his/her incumbency the implementing rules and regulations (IRR) within
in the PRB unless sooner replaced by the PRB six (6) months from the effectivity of this Act.
concerned through a resolution, subject to the • Fraudulent acts relating to the implementation and
approval of the PRC. enforcement of this Act shall be punishable under the
• The first and second members shall have a term of pertinent provisions of the Revised Penal Code, the
office of two (2) years unless sooner replaced through New Civil Code and other applicable laws.
a resolution by the AIPO/APO concerned or the • A professional who is adjudged guilty of any
organization of deans or heads of departments, fraudulent act relating to the CPD shall also be meted
respectively. However, members of the CPD Council with the penalty of suspension or revocation of his/her
who are appointed by the PRC may be replaced PRC Certificate of Registration and/or Certificate of
before the end of the two (2)-year period, upon the Specialization. In case of a government official or
recommendation of the PRB through a resolution. employee who is party to any fraudulent act relating
POWERS, FUNCTIONS AND RESPONSIBILITIES OF to the CPD, he/she shall also be subject to the
THE CPD COUNCIL - THE CPD COUNCIL FOR EACH administrative penalties that may be imposed under
PROFESSION the anti-graft laws, the Administrative Code and the
• Ensure the adequate and appropriate provision of Code of Conduct of Public Officials and Employees.
CPD Programs for their respective profession; • Separability Clause. If any part or provision of this
• Evaluate and act on applications for accreditation of Act is declared invalid or unconstitutional, the other
CPD Providers and their CPD Programs;
 provisions not affected thereby shall remain in full www.prc.gov.ph or available at Standards and
force and effect. Inspection Division office.
• Repealing Clause. All laws, decrees, executive • How long is the processing of the application for
orders and other administrative issuances or parts accreditation as CPD Provider?
thereof, which are inconsistent with the provisions of − The period for processing the application is 30 days.
this Act, are hereby repealed or modified accordingly. • What is the validity of accreditation for CPD
• Effectivity. - This Act shall take effect fifteen (15) Provider?
days following its complete publication in the Official − The accreditation of CPD Provider is valid for three
Gazette or in two (2) newspapers of general (3) years.
circulation in the Philippines. • What is the regulatory period for the filing of
PRC RESOLUTION NO. 1032 SERIES OF 2017 application for accreditation of CPD program/s?
“Implementing Rules and Regulations (IRR) of Republic − The CPD Program/s shall be applied 45 days prior to
Act No. 10912 known as the Continuing Professional the conduct of the program
Development (CPD) Act of 2016” • How much are the prescribed fees for
CPD COUNCIL accreditation of CPD Providers, CPD Programs,
• Every CPD Council shall be composed of chairperson Self-Directed Learning and/or Lifelong Learning?
and two (2) members. − The Prescribed fees for accreditation are as follows:
• The Chairperson shall act in the following functions: − Local CPD provider P 5,000.00
− Preside the meetings − Foreign CPD provider P 8,000.00
− Direct or supervise the activities − CPD program per offering P 1,000.00
− Submit the Council’s annual report to the − Self-directed and/or Lifelong Learning per program P
Planning and Monitoring Division not later than 500.00
January 15 of the succeeding year • Who are not covered by the CPD Requirement?
− Sign the following: − Professionals working overseas. However, they need
▪ CoA: Certificate of Accreditation of qualified to provide proof such as valid Certificate of
CPD providers Employment or Overseas Employment Certificate
▪ CoAP: Certificate of Accreditation of Program duly approved by POEA.
▪ CCU: Certificate of Credit Units for self- − Newly licensed professionals for the first renewal
directed and/pr lifelong learning 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
CPD PROVIDERS human immune system, and destroys or impairs the
• Local CPD Provider cells' function. Infection with HIV results in the
− Individual/Sole Proprietor progressive deterioration of the immune system.
Leading to immune deficiency.
− Firm/Partnership/Corporation
− Condition in human in which the virus invades the
− Government Institutions/Agencies
CD4+ t lymphocytes – type of immune cells the
• Foreign CPD Provider
stimulates killer t-cells, macrophages and b-cells to
− Foreign Entity/Firm /Association
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
FREQUENTLY ASKED QUESTIONS percentage below 14% are considered to have
HIV/AIDS
• Where to get the application forms?
− The Continuing Professional Development (CPD)
forms can be downloaded from PRC website at
 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
 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.
PREVALENCE OF HIV IN DIFFERENT AGE GROUPS • 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.
PREVALENCE OF HIV ACCORDING TO THE MODES (b) Adopt a multi-sectoral approach in responding to
OF TRANSMISSION 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
REPUBLIC ACT NO. 11166 • Anti-retroviral Therapy (ART): treatment that stops
GENERAL INFORMATION or suppresses viral replication or replications of a
• RA 8504: “Philippine AIDS Prevention and Control retrovirus like HIV, thereby slowing down the
Act of 1998” progression of infection;
− Consists of 9 articles • Bullying: severe or repeated use by one or more
− With 52 sections persons of a written, verbal or electronic expression,
− Approved on February 13, 1998 by President or a physical act of gesture, directed at another
Fidel V. Ramos person in reasonable fear of physical or emotional
• RA 11166: "Philippine HIV and AIDS Policy Act” harm or damage to one's property; creating a hostile
− The newest law passed by the legislative environment; infringing on the rights; or materially and
department to modify certain provision of the substantially disrupting the processes or orderly
original version to be more effective in dealing operation of an institution or organization;
HIV condition in the Philippine setting. • Civil Society Organizations (CSOs): groups of
− An act strengthening the Philippine nongovernmental and noncommercial individuals or
Comprehensive Policy on HIV/AIDS prevention, legal entities;
treatment, care, and support, and, reconstituting • Compulsory HIV Testing: HIV testing imposed upon
the Philippine National Aids Council (PNAC), an individual characterized by lack of consent, use of
repealing for the purpose Republic Act No. 8504 force or intimidation, the use of testing as a
− Consists of 8 articles prerequisite for employment or other purposes, and
− With 57 sections other circumstances when informed choice is absent;
− Approved on December 20, 2018 by President • Discrimination: unfair or unjust treatment that
Rodrigo R. Duterte distinguishes, excludes, restricts, or shows
DECLARATION OF POLICIES preferences (sex gender, age, sexual orientation,
− HIV/AIDS are public concerns that have wide ranging gender identity and expression, economic status,
social, political, and economic repercussions. disability, ethnicity, and HIV status) which has the
• Responding to the country's HIV and AIDS shall be purpose or effect of nullifying or impairing the
anchored on the principles of human rights upholding recognition, enjoyment or exercise by all persons
human dignity. similarly situated, of all their rights and freedoms;
• Policies and practices that discriminate (HIV status, • Gender Expression: the way a person
sex, gender, sexual orientation, gender identity and communicates gender identity to others through
expression, age, economic status, disability, and behavior, clothing, hairstyles, communication or
ethnicity) or hamper the enjoyment of basic human speech pattern, or body characteristics;
• Gender Identity: personal sense of identity as • Medical Confidentiality: core duty of medical
characterized, among others, by manner of clothing, practice where the information provided by the patient
inclinations, and behavior in relation to masculine or to health practitioner and his/her health status is kept
feminine conventions. A person may have a male or private and is not divulged to third parties. The
female identity with the physiological characteristics patient's health status can however, be shared with:
of the opposite sex; − Other medical practitioner involved in the
• Health Maintenance Organizations (HMO): juridical professional care of the patient
entities legally organized to provide or arrange for the − Attending physician, consulting medical
provision of pre-agreed or designated health care specialist, nurse and medical technologist
services to its enrolled members for a fixed pre-paid − All other health workers or personnel involved in
fee for a specified period of time; any counseling, testing or professional care of the
• High-risk Behavior: person's involvement in certain patient
activities that increase the risk of transmitting or • Opportunistic infections: illnesses caused by
acquiring HIV; various organism, many of which do not cause
− Ex: having sex with homosexual, injecting drugs, diseases in persons with healthy immune system;
sharing needle equipment, having unprotected sex • Partner Notification: process by which the "index
with someone with a high-risk behavior client", "source", or "patient" who has a sexually
• HIV Counseling: interpersonal and dynamic transmitted infection (STI) including HIV, is given
communication process between a client and a support in order to notify and advise the partners that
trained counselor, whose objective in counseling is to have been exposed to infection;
encourage the client to explore important personal • Person Living with HIV (PLHIV): any individual
issues, identify ways of coping with anxiety and diagnosed to be infected with HIV;
stress, and plan for the future (keeping healthy, • Pre-exposure Prophylaxis: use of prescription
adhering to treatment, and preventing transmission); drugs as a strategy for the prevention of HIV infection
and in the context of a negative HIV test result, to by people who do not have the HIV and AIDS. It is an
encourage the client to explore motivations, options, optional treatment, which may be taken by people
and skills to stay HIV-negative; who are HIV negative but who have substantial,
• HIV and AIDS Counselor: any individual trained by higher-than-average risk of contracting an HIV
an institution or organization accredited by the infection;
Department of Health (DOH) to provide counseling • Pre-test Counseling: process of providing an
services on HIV and AIDS with emphasis on behavior individual with information on the biomedical aspects
modification; of HIV AIDS, and emotional support to any
• HIV and AIDS Monitoring: documentation and psychological implications of undergoing HIV testing
analysis of the number of HIV and AIDS infections and the test result itself before the individual is
and the pattern of its spread; subjected to the test;
• HIV and AIDS Prevention and Control: measures • Post-exposure Prophylaxis: preventive medical
aimed at protecting non-infected persons from treatment started immediately after exposure to
contracting HIV and minimizing the impact of the pathogen (HIV) in order to prevent infection by the
condition on persons living with HIV; pathogen and the development of the disease;
• HIV-Negative: absence of HIV or HIV antibodies • Post-test Counseling: process of providing risk-
upon HIV testing; reduction information and emotional support to a
• HIV-Positive: refers to the presence of HIV infection person who submitted to HIV testing at the time the
as documented by the presence of HIV and HIV result is released;
antibodies in the sample being tested; • Prophylactic refers to any agent or device used to
• HIV Testing: any facility-based, mobile medical prevent the transmission of an infection;
procedure, or community-based screening modalities • Redress: refers to an act of compensation for
that are conducted to determine the presence or unfairness, grievance, and reparation;
absence of HIV in a person's body. • Sexually Transmitted Infections (STIs): infections
− HIV testing is confidential and voluntary in nature and that are spread through the transfer of organisms
it must be accompanied by a counselling prior to and from one person to another as a result of sexual
after the testing and conducted only with the informed contact;
consent of a person. • Sexual Orientation: direction of emotional, sexual
• HIV Testing Facility: DOH accredited on-site or attraction, or conduct towards people of the same sex
mobile testing center, hospital, clinic, laboratory, and (homosexual orientation) or towards people of both
other facility that has the capacity to conduct sexes (bisexual orientation) or towards people of the
voluntary HIV counseling and HIV testing; opposite sex (heterosexual orientation) or to the
• Informed Consent: voluntary agreement of a person absence of sexual attraction (asexual orientation);
to undergo or be subjected to a procedure based on • Stigma: dynamic devaluation and dehumanization of
full information, whether such permission is written or an individual in the eyes of others
conveyed verbally; • Treatment hubs: private and public hospitals or
• Laboratory: area or place, including community- medical establishments accredited by the DOH to
based settings, where research studies are being have the capacity and facility to provide treatment and
undertaken to develop local evidence for effective HIV care services to PLHIV;
response; • Voluntary HIV testing: HIV testing done on an
• Mature Minor Doctrine: legal principle that individual who, after having undergone pre-test
recognizes the capacity of some minors to consent counseling willingly submits to such test;
independently to medical procedures, if they have • Vulnerable communities: communities and groups
been assessed by qualified health professionals to suffering from vulnerabilities such as unequal
understand the nature of procedures and their opportunities, social exclusion, poverty,
consequences to make a decision on their own; unemployment, and other similar social exclusion,
 making them more susceptible to HIV infection and to • Meeting: at least once every quarter in the presence
developing AIDS; and of the Chairperson or the Vice Chairperson, and at
• Workplace: office, premise or work site where least ten (10) other members and/or permanent
workers are habitually employed and shall include the representatives.
office or place where workers regularly report for • The Secretary of Health shall be the permanent
assignment in the course of their employment. Chairperson of the PNAC.
THE PHILIPPINE NATIONAL AIDS COUNCIL • The Vice Chairperson shall be elected from the
• Philippine National AIDS Council (PNAC) was government agency members and shall serve for a
established to ensure the implementation of the term of three (3) years.
country's response to the HIV and AIDS situation. It • Members representing CSOs shall serve for a term
shall be an agency attached to the DOH. of three (3) years renewable upon recommendation
• Functions: of the Council for a maximum of two (2) consecutive
(a) Develop the AIDS Medium Term Plan (AMTP) in terms – 6 years maximum term
collaboration with relevant government agencies, AIDS MEDIUM TERM PLAN (AMTP) – The latest AMTP
CSOs, the PLHIV community; covers 2017-2022
(b) Ensure the operationalization and • The PNAC shall formulate and periodically update the
implementation of the AMTP; six (6)-year AMTP, a national multi-sectoral strategic
(c) Strengthen the collaboration between plan to prevent and control the spread of HIV and
government agencies and CSOs; AIDS in the country. The AMTP shall include the
(d) Develop and ensure the implementation of the following:
guidelines and policies provided in this Act; (a) The country's target and strategies in addressing
(e) Monitor the progress of the response to the the HIV and AIDS situation;
country's HIV and AIDS situation; (b) (b)The prevention, treatment care and support,
(f) Monitor the implementation of the AMTP and other components of the country's response;
(g) Mobilize sources of funds for the AMTP; (c) The operationalization of the program and
(h) Mobilize its members to conduct monitoring and identification of the government agencies
evaluation of HIV-related programs, policies, and responsible for implementing, overseeing,
services within their mandate; coordinating, facilitating, and monitoring;
(i) Coordinate, organize, and work in partnership (d) The budgetary requirements and identify the
with foreign and international organizations sources of funds for its implementation.
(funding, data collection, research, and ROLE OF DEPARTMENT OF HEALTH
prevention and treatment modalities on HIV and • The National HIV and AIDS and STI Prevention and
AIDS) and ensure foreign funded programs are Control Program (NASPCP) of the DOH, which shall
aligned to the national response; be composed of qualified medical specialist and
(j) Advocate for policy reforms to Congress and support personnel shall coordinate with the PNAC.
other government agencies; • The Epidemiology Bureau shall maintain a
(k) Submit an annual report to the Office of the comprehensive HIV and AIDS monitoring and
President, Congress, and the members of the evaluation program that shall serve the following
Council; purposes:
(l) Identify gaps in the national response on the part (a) Determine and monitor the magnitude and
of government agencies and its partners from progression of HIV and AIDS in the Philippines
civil society and international organizations; (b) Receive, collate, process, and evaluate all HIV-
(m) Recommend policies and programs and-AIDS-related medical reports from all
• Memberships and Composition: hospitals, clinics, laboratories and testing centers
(1) Department of Health (DOH); (it shall adopt a coding system that ensures
(2) Department of Education (DepEd); anonymity and confidentiality)
(3) Department of Labor and Employment (DOLE); (c) Submit, through its Secretariat, quarterly and
(4) Department of Social Welfare and Development annual reports to the PNAC containing the
(DSWD); findings of its monitoring and evaluation activities
(5) Department of the Interior and Local Government in compliance with this mandate.
(DILG); PROTECTION OF HUMAN RIGHTS
(6) Civil Service Commission (CSC); • The country's response to the HIV and AIDS situation
(7) Commission on Higher Education (CHED); shall be anchored on the principle of human rights
(8) National Youth Commission (NYC); and human dignity. Public health concerns shall be
(9) Philippine Information Agency (PIA); aligned with internationally-recognized human rights
(10) Department of Budget and Management; instruments and standards.
(11) The Chairperson of the Committee on Health • Towards this end, the members of the PNAC, in
and Demography of the Senate of the Philippines cooperation with CSOs, and in collaboration with the
or his representative; Department of Justice (DOJ) and the Commission on
(12) The Chairperson of the Committee on Health of Human Rights (CHR), shall:
the House of Representative or his (a) ensure the delivery of non-discriminatory HIV and
representative; AIDS services by government and private HIV
(13-14) Two (2) representatives from organizations of and AIDS service provider
persons living with HIV and AIDS; (b) take the lead in developing redress mechanisms
(15) One (1) representative from a private for PLHIV and key affected populations to ensure
organization with expertise in standard setting and that their civil, political, economic, and social
service delivery; and rights are protected
(16-21) Six (6) representatives from NGOs working INFORMATION, EDUCATION AND COMMUNICATION
for the welfare or identified key populations.
• Education in Learning Institutions: DepEd, CHED, • The DOH shall establish a program to prevent
and Technical Education and Skills Development mother-to-child HIV transmission that shall be
Authority (TESDA) integrated in its maternal and child health services.
− Basic and age-appropriate instruction on the causes, • Standard Precaution on the Donation of Blood,
modes of transmission, and ways of preventing the Tissue, or Organ. The DOH shall enforce the
spread of HIV and AIDS and other STIs in their following guidelines on the donation of blood, tissue,
respective curricula taught in public and private or organ:
learning institutions, including alternative and (a) Donation of tissue or organ shall be accepted by
indigenous learning systems. a laboratory or institution only after a sample from
• Education for Parents and Guardians: DepEd in the donor has been tested negative for HIV;
coordination with parent-teacher organizations (b) All donated blood shall also be subjected to HIV
− Conduct awareness-building seminars in order to testing;
provide parents and guardians with a gender- (c) All donors whose blood, organ or tissue has been
responsive and age-sensitive HIV and AIDS tested positive shall be deferred from donation,
education. notified of their HIV status, counselled, and
• Education as Right to Health and Information: HIV referred for care and clinical management as
and AIDS education and information dissemination soon as possible;
shall form part of the constitutional right to health. (d) Donations of blood, tissue, or organ testing
• HIV and AIDS Information as a Health Service: HIV positive for HIV may be accepted for research
and AIDS education and information dissemination purposes only, and shall be subject to strict
shall form part of the delivery of health services by sanitary disposal requirements; and
health practitioners, workers, and personnel. (e) A second testing may be demanded as a matter
− The training of health workers shall include of right by the blood, tissue, or organ recipient or
discussions on HIV-related ethical issues such as his/her immediate relatives before transfusion or
confidentiality, informed consent, and the duty to transplant, except during emergency cases.
provide treatment. SCREENING, TESTING AND COUNSELING
• Education in the Workplace: DOLE for the private • As a policy, the State shall encourage voluntary HIV
sector, Civil Service Commission for the public sector, testing. Written consent from the person taking the
and AFP and PNP for the uniformed service shall test must be obtained before HIV testing.
implement this provision. − Fifteen (15) to below eighteen (18) years of age,
− Public and private employers and employees, consent to voluntary HIV testing shall be obtained
members of the Armed Forces of the Philippine (AFP) from the child without the need of consent from a
and the Philippine National Police (PNP) shall be parent or guardian;
regularly provided with standardized basic − Young person aged below fifteen (15) who is
information and instruction of HIV and AIDS, including pregnant or engaged in high-risk behavior shall
topics on confidentiality in the workplace and be eligible for HIV testing and counseling, with the
reduction or elimination of stigma and discrimination. assistance of a licensed social worker or health
• Education for Filipinos Going Abroad: DOLE, worker.
Philippine Overseas Employment Agency (POEA) − Consent to voluntary HIV testing shall be
and the Overseas Workers Welfare Administration obtained from the child's parent or legal guardian
(OWWA), the Department of Foreign Affairs (DFA), if the person is below fifteen (15) years of age or
and the Commission on Filipino Overseas (CFO) is mentally incapacitated.
− Attend a seminar on the causes, manner of • Compulsory HIV testing shall be allowed only in the
prevention, and impact of HIV and AIDS, before being following instances:
granted a certification for overseas assignment. − To test a person who is charges with any of the
• Information for Tourists and Transients: Philippine offenses punishable by law (serious and slight
Information Agency, Department of Tourism (DOT) physical injuries, rape and simple seduction)
and Department of Transportation (DOTr) − When it is necessary to resolve relevant issues
− Educational materials shall be adequately provided at under Executive Order No. 209, otherwise known
all international and local ports of entry and exit. as "The Family Code of the Philippines"
• Education in Communities: DILG, the Union of Local − As a prerequisite in the donation of blood
Authorities of the Philippines (ULAP), the League of HEALTH AND SUPPORT SERVICES
Provinces of the Philippines (LPP), the League of • Treatment of Persons Living with HIV and AIDS.
Cities of the Philippines (LCP), the League of The DOH shall establish a program that will provide
Municipalities of the Philippines (LMP), and Liga ng free and accessible ART and medication for
mga Barangay sa Pilipinas through the Local AIDS opportunistic infections to all PLHIVs who are enrolled
Councils (LAC) or the local health boards, Local in the program.
Council for the Protection of Children (LCPC), • Access to Medical Services by Indigents. Indigent
Sangguniang Kabataan and Association of Barangay persons living with HIV shall not be deprived of
Captains access to medical services.
− Indigenous people communities and geographically • Economic Empowerment and Support. PLHIV
isolated and disadvantaged areas (GIDA) shall also shall not be deprives of any employment, livelihood,
be given due focus in the implementation of this micro-finance, self-help, and cooperative programs
section. by reason of their HIV status.
− The DILG, DSWD and the NYC, shall also conduct • Care and Support for Persons Living with HIV.
age-appropriate HIV and AIDS education for out-of- Peer-led counseling and support, social protection,
school youth. welfare assistance, and mechanisms for case
PEVENTIVE MEASURES, SAFE PRACTICES AND management.
PROCEDURES • 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 ▪ To discuss the advantages of NBS, significance,
GENERAL INFORMATION information and others crucial to understanding
• Republic Act 9288 and dissemination of the program
• Newborn Screening Act of 2004 − As part of responsible Parenthood, parents must
• Senate No. 2707 (February 2, 2004) and House No. recognize their responsibilities in promoting child’s life
6625 (February 5, 2004) and health from preventable disorders that can cause
• Approval Date: April 7, 2004 disability and death
• Signed by: President Gloria Macapagal-Arroyo DEFINITION OF TERMS
• Presidential Proclamation No. 540 on Jan 20, 2004: • Comprehensive Newborn Screening System
“Newborn Screening Week” means a newborn screening system that includes, but
SUMMARY OF RA 9288 is not limited to:
• Consists of 19 Sections − Education of relevant stakeholders;
− Short Title, Declaration of Policy, Objectives, − Collection and biochemical screening of blood
Definitions, Obligation to Inform, Performance of samples taken from newborns;
Newborn Screening, Refusal to be Tested, − Tracking and confirmatory testing to ensure the
Continuing Education, Re-education and Training accuracy of screening results;
Health Personnel, Licensing and Accreditation, Lead − Clinical evaluation and biochemical/medical
Agency, Advisory Committee on Newborn Screening, confirmation of test results;
Establishment and Accreditation of Newborn − Drugs and medical/surgical management and
Screening Centers, Establishment of a Newborn dietary supplementation to address the heritable
Screening Reference Center, Quality Assurance, conditions;
Database, Newborn Screening Fees, Repealing − Evaluation activities to assess long term
Clause, Separability Clause, Effectivity outcome, patient compliance and quality
• Five Articles: assurance.
1. General Provisions - Sections 1, 2, 3 • Follow-up means the monitoring of a newborn with a
2. Definition of Terms - Section 4 heritable condition for the purpose of ensuring that the
3. Newborn Screening - Sections 5, 6, 7, 8, 9 newborn patient complies fully with the medicine or
4. Implementation - Sections 10, 11, 12, 13, 14, 15, 16 dietary prescriptions.
5. Final Provisions - Sections 17, 18, 19 2 REASONS
DECLARATION OF THE POLICY 1. To ensure that the newborn patient complies fully
• It is the policy of the State to: with the treatment intervention
− Protect and promote the right to health of the people, 2. To know whether there is a progression of the
including the rights of children to survival and full and disease and whether effective treatment has
healthy development as normal individuals. been given.
− Institutionalize a national newborn screening system • Health institutions mean hospitals, health
that is comprehensive, integrative and sustainable, infirmaries, health centers, lying-in centers or
and will facilitate collaboration. puericulture centers with obstetrical and pediatric
− The National Newborn Screening System shall services, whether public or private.
ensure that every baby born in the Philippines is • Healthcare practitioner means physicians, nurses,
offered the opportunity to undergo newborn screening midwives, nursing aides and traditional birth
and thus be spared from heritable conditions that can attendants.
lead to mental retardation and death if undetected • Heritable condition means any condition that can
and untreated. result in mental retardation, physical deformity or
ELEMENTS OF NEWBORN SCREENING death if left undetected and untreated and which is
• It is a requirement to institutionalize NBS as a public usually inherited from the genes of either or both
health program that aims to ensure that every child biological parents of the newborn.
delivered is screened from various heritable diseases • NIH means the National Institute of Health
that may lead to mental retardation and worst-case − Confirmatory Center, Newborn Screening Reference
scenario death. Center, and the central facility within the NIH that is
1. Comprehensive pass to oversee as far as all the protocols, guidelines,
2. Integrative training, updates, informational brochure content, and
3. Sustainable they also provide externa provide external QA
4. Collaborative (proficiency testing – sort of accreditation) are
OBJECTIVES 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
− The Government will establish and integrate and provides all required laboratory tests and
sustainable (no period, continuous) NBS as part of recall/follow-up programs for newborns with heritable
public health delivery system (meaning everyone conditions.
must afford)
− Practitioners as front liners/ middleman must know its
obligation:
• Parent education means the various means of IMPLEMENTATION
providing parents or legal guardians information • Lead Agency
about newborn screening. − The DOH shall be the lead agency in implementing
• Recall means a procedure for locating a newborn this act.
with a possible heritable condition for purposes of 1) Establish the Advisory Committee on Newborn
providing the newborn with appropriate laboratory to Screening;
confirm the diagnosis and, as appropriate, provide 2) Develop the implementing rules and regulations
treatment. for the immediate implementation of a nationwide
• Treatment means the provision of prompt, newborn screening program within one hundred
appropriate and adequate medicine, medical, and eight (180) days from the enactment of this Act;
surgical management or dietary prescription to a 3) Coordinate with the Department of the Interior
newborn for purposes of treating or mitigating the and Local Government (DILG) for implementation
adverse health consequences of the heritable of the newborn screening program;
condition. 4) Coordinate with the NIH Newborn Screening
NEWBORN SCREENING Reference Center for the accreditation of
• Obligation to Inform Newborn Screening Centers and preparation of
− Health practitioner: inform the parents or legal defined testing protocols and quality assurance
guardian of the newborn of the availability, nature and programs.
benefits of newborn screening prior to delivery • Advisory Committee on Newborn Screening
− Department of Health (DOH): appropriate − Integral part of the Office of the Secretary of the
notification and education regarding this obligation DOH
• Performance of Newborn Screening − Functions:
− Performed after twenty-four (24) hours of life but not 1) review annually and recommend conditions to be
later than three (3) days from complete delivery of included in the newborn screening panel of
the newborn. disorders;
− Newborn in intensive care: may be exempted from the 2) review and recommend the newborn screening
3-day requirement but must be tested by seven (7) fee to be charged by Newborn Screening
days of age. Centers;
− Joint responsibility of the parent(s) and the 3) review the report of the Newborn Screening
practitioner or other person delivering the newborn to Reference Center on the quality assurance of the
ensure that newborn screening is performed. 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
• Refusal to be Tested: appointed for a term of three (3) years, subject to
− On the grounds of religious beliefs, but shall their being reappointed for additional three (3)
acknowledge in writing their understanding that years period for each extension.
refusal for testing places their newborn at risk for ▪ Meeting: At least twice a year. The NIH shall
undiagnosed heritable conditions. serve as the Secretariat of the Committee.
− Refusal documentation shall be made part of the • Establishment and Accreditation of Newborn
newborn's medical record and refusal shall be Screening Centers
indicated in the national newborn screening − The DOH shall ensure that Newborn Screening
database. Centers are strategically located in order to be
• Continuing Education, Re-education and Training accessible to the relevant public and provide services
Health Personnel that comply with the standards approved by the
− The DOH, with the assistance of the NIH and other Committee upon the recommendation of the NIH.
government agencies, professional societies and − No Newborn Screening Center shall be allowed to
non-government organizations, shall: operate unless it has been duly accredited by the
− (i) conduct programs for health personnel on the DOH based on the standards set forth by the
rationale, benefits, procedures of newborn screening Committee.
− (ii) disseminate information materials on newborn − Every Newborn Screening Center shall:
screening at least annually to all health personnel i. Have a certified laboratory performing all tests
involved in maternal and pediatric care. included in the newborn screening program,
ii. Have a recall/follow up programs for infants found
• Licensing and Accreditation
positive for any and all of the heritable conditions;
− The DOH and the Philippine Health Insurance
iii. Be supervised and staffed by trained personnel
Corporation (PHIC) shall require health institutions to
who have been duly qualified by the NIH;
provide newborn screening services as a condition for
licensure or accreditation.
 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 The pathway produces NADPH that functions as
Congenital Adrenal Hyperplasia (CAH) electron donor in maintaining glutathione in its
is a group of disorders resulting from reduced form. The glutathione serves as an
enzymatic defects in the biosynthesis of antioxidant that protects the cells against oxidative
steroids. damage.
• There are many enzymes involved • Other associated disorders to G6PD deficiency are
in the synthesis of adrenal decreased RBC lifespan and cataract formation.
hormones but in about 90% of CAH, − Splenomegaly
it is due to 21-hydroxylase • There is no cure for G6PD deficiency, but the main
deficiency. Others are due to goal in the management is avoidance of oxidative
cholesterol desmolase 11β- insults [bacterial infections, viral infections,
hydroxylase deficiency, 17β-hydroxylase deficiency analgesics, antipyretics (aspirin), antibiotics
and 3β-hydroxysteroid dehydrogenase. (bactrim), anti-malarial drug (chloroquine), favism
− Adrenal glands sit atop the kidney. It produces (soya food, fava beans),naphthalene balls] and blood
cortisol, aldosterone, androgens, and transfusions for acute hemolytic crisis.
catecholamines. These hormones regulate the GALACTOSEMIA
metabolism, help in the immunity, regulate blood • Galactosemia is a rare genetic
pressure and maintain sexual characteristics. metabolic disorder that is inherited in an
• All forms of CAH are inherited in an autosomal autosomal recessive manner. It is an
recessive pattern. inborn error of carbohydrate metabolism
• The mainstay of treatment in CAH is glucocorticoid characterized by elevated levels of
and mineralocorticoid replacement therapy which galactose and its metabolites due to
corrects the cortisol deficiency and reverses the enzyme deficiencies involved in its
abnormal hormonal patterns. metabolism.
PHENYLKETONURIA − Accumulation of galactose
• Phenylketonuria (PKU) is a • Dietary elimination of milk and milk products containing
disorder of aromatic amino acid lactose is the treatment for all types of galactosemia.
metabolism in which There is no chemical or drug substitute for the missing
phenylalanine cannot be enzyme at this time.
converted to tyrosine due to a
REPUBLIC ACT NO. 7719
deficiency or absence of the
enzyme phenylalanine − “NATIONAL BLOOD SERVICES ACT OF 1994”
hydroxylase. • World Blood Donor Day takes place on June 14
− If phenylalanine accumulated in the brain, it is each year. The aim is to raise global awareness of
neurotoxic causing mental retardation. the need for safe blood and blood products for
• The odor of the phenylketonuric patient is that of transfusion and of the critical contribution
phenylacetic acid described as mousy, barny, or voluntary, unpaid blood donors make to national
musty. health systems.
• Dietary management is key to treatment like complete • The day also provides an opportunity to call to action
avoidanceof food containing high amounts of to governments and national health authorities to
phenylalanine. provide adequate resources and put into place
MAPLE SYRUP URINE DISEASE systems and infrastructures to increase the collection
• Maple syrup urine disease of blood from voluntary, non-remunerated blood
(MSUD) is due to a defect or donors
deficiency of the branched chain • Of the 118.5 million blood donations collected
ketoacid dehydrogenase complex globally, 40% of these are collected in high-income
in which elevated quantities of countries, home to 16% of the world’s population.
leucine, isoleucine, valine, and • An increase of 7.8 million blood donations from
their corresponding oxoacids voluntary unpaid donors have been reported from
accumulate in body fluids. The 2013 to 2018. In total, 79 countries collect over 90%
increase in leucine may cause of their blood supply from voluntary unpaid blood
competitive inhibition with other precursors of donors; however, 56 countries collect more than 50%
neurotransmitters causing the neurologic of their blood supply from family/replacement or paid
manifestations. donors – Pay a person to give you blood
• Long term treatment of MSUD is based on dietary • The Department of Health (DOH) finally realized its
restriction of branched-chain amino acids and goal of collecting one (1) million blood units from the
supplementation of thiamine if proven beneficial; total population; two decades after the National Blood
valine and isoleucine supplementation is also Services Act of 1994 (Republic Act No. 7719) was
recommended. signed into law.
GLUCOSE-6-PD DEFICIENCY • Last December 2017, the country’s goal to obtain the
• G6PD-deficiency is an X-linked 1% (1 million blood units) blood collection from the
disorder found in both sexes but total population was achieved and collected
more males are affected. 1,120,408 blood units. This represents a significant
• The most common clinical contribution to the global call for a 100% voluntary
manifestation of G6PD deficiency is blood donation by the World Health Organization.
hemolytic anemia induced by REPUBLIC ACT NO. 7719
various oxidative stresses. SECTION I. TITLE
− G6PD is an enzyme that is present • This act shall be known as the “National Blood
in all cells but is much valued in RBC. It is needed for Services Act of 1994”
the 1st step in the hexose monophosphate pathway.
• An act promulgating voluntary blood donation, responsibility of carrying out the provisions of this Act;
providing for an adequate supply of safe blood, and
regulating blood banks and providing penalties for • Walking Blood Donor – An individual included in the
violation thereof. list of qualified voluntary blood donors referred to in
• Approved in May 5, 1994 by Pres. Fidel V. Ramos Section 4, paragraph (e), who is ready to donate
SECTION II. DECLARATION OF POLICIES blood when needed in his/her community.
• To promote and encourage voluntary blood donation SECTION IV. PROMOTION OF VOLUNTARY BLOOD
by the principle that blood donation is a DONATION
humanitarian act • In order to ensure adequate supply of human blood,
• To lay down the legal principle of blood transfusion is a voluntary blood donation shall be promoted through
a professional medical service and not a sale of a the following:
commodity a. Public Education
• To provide adequate, safe, affordable and equitable − Organized and sustained nationwide public
distribution of supply of blood and blood products education campaign by the Department, the
• To inform the public of the voluntary blood donation Philippine National Red Cross (PNRC) and the
to curb hazards caused by the commercial sale of Philippine Blood Coordinating Council (PBCC),
blood set aside funds and generate financial support for
• To teach the benefits and rationale in the existing all sectors.
health subjects of the formal education systems b. Promotion in Schools
and non-formal education systems − Benefits and rationale of voluntary blood donation
• To mobilize all the sectors of the community to shall be included and given emphasis in health
participate in mechanisms for voluntary and non-profit subjects of schools, both public and private, at the
collection of blood elementary, high school and college levels.
• To mandate the DOH to establish and organize a − Required by the DECS in the inclusion of non-
National Blood Transfusion Service Network – formal education curricula
Can request blood type in other partnered centers c. Professional Education
• Assistance to institution promoting voluntary blood − Continuing medical education, trainings on the
donation providing non-profit blood services rational use of blood products including merits of
• To require all blood collection units and blood voluntary blood donation
banks/centers to operate a non-profit basis – Tax d. Establishment of Blood Services Network
exempted and charitable − Blood Centers shall be strategically established in
• To establish scientific and professional standards every province and city nationwide
for the operation of blood collection units and blood − The promotion of blood collection in schools,
bank/centers business enterprises, barangay and military
• To regulate and ensure the safety of all activities camps shall be promoted
related to the collection, storage and banking of − By the help of:
blood ▪ Department of Health (DOH)
− HIV and Malaria – Diseases acquired from blood ▪ Philippine Blood Coordinating Council
transfusion (PBCC)
• Upgrading of blood banks/centers for preventive ▪ Philippine Society of Hematology and Blood
services and education Transfusion (PSHBT)
SECTION III. DEFINITIONS ▪ Philippine Medical Association (PMA)
• Blood/Blood Product – Refers to human blood, ▪ Philippine Association of Medical
processed or unprocessed and includes blood Technologists (PAMET)
components, its products and derivatives; ▪ Philippine Nurses Association (PNA)
e. Walking Donors
• Blood Bank/Center – A laboratory or institution with
the capability to recruit and screen blood donors, − In areas where there may be inadequate blood
collect, process, store, transport and issue blood for banking facilities, the walking blood donor
transfusion and provide information and/ or education concept shall be encouraged and all government
on blood transfusion transmissible diseases; hospitals, rural-health units, health centers and
barangays in these areas shall be required to
• Commercial Blood Bank – A blood bank that exists
keep at all times a list of qualified blood donors
for profit;
with their specified blood typing.
• Hospital-Based Blood Bank – A blood bank which
SECTION V. NATIONAL VOLUNTARY BLOOD
is located within the premises of a hospital, and which
SERVICES PROGRAM
can perform compatibility testing of blood/cross
• A program to meet an evolutionary manner, needs for
matching;
blood transfusion in all region of the country.
• Blood Collection Unit – An institution or facility duly
• Funds for this purpose shall be provided by the
authorized by the Department of Health to recruit and
government through the following institutions:
screen donors and collect blood;
− PCSO (P25,000,000.00)
• Voluntary Blood Donor – One who donates blood
on one’s own volition or initiative and without − PAGCOR (P25,000,000.00)
monetary compensation; − Duty Free Shop (P20,000,000.00)
• Department – The Department of Health; − Other contributions from other agencies such as
• Blood Transfusion Transmissible Diseases – civic organization
Diseases which may be transmitted as a result of SECTION VI. UPGRADING OF SERVICES AND
blood transfusion, including AIDS, Hepatitis-B, FACILITIES
Malaria and Syphilis; • All blood banks/centers shall provide preventive
• Secretary of Health – The Secretary of Health or any health services such as education and counseling on
other person to whom the Secretary delegates the blood transfusion transmittable diseases.
− Philippine Society of Hematology and Blood • Rules and regulations shall be promulgated sixty (60)
Transfusion (PSHBT) days from the approval thereof
− Philippine Society of Pathologists (PSP) • The rules and regulations shall prescribe from time to
• All government hospitals shall be required to establish time the maximum ceiling for fees for the provision of
voluntary blood donation programs and private blood, including its collection, processing and
hospitals are encourage to establish the said program storage, professional services and a reasonable
also. allowance for spoilage.
SECTION VII. PHASE-OUT OF COMMERCIAL BLOOD SECTION XII. PENALTIES
BANKS • Any blood bank/center which shall collect charges
• All commercial blood banks shall be phased-out over and fees greater than the maximum prescribed by the
a period of two (2) years after effectivity of this Act. Department shall have its license suspended or
• Extended to a maximum period of two (2) years by the revoked by the Secretary.
Secretary − IMPRISONMENT: not less than one (1) month nor
SECTION VIII. NON-PROFIT OPERATION more than six (6) months
• All blood banks/centers shall operate on a non-profit − FINE: not less than Five thousand pesos (P5,000) nor
basis; Provided, that they may collect service fee more than Fifty thousand pesos (P50,000)
not greater than the maximum prescribe by the • Any person who shall establish and operate a blood
Department. bank without securing any license to operate from the
• BLOOD SHALL BE COLLECTED FROM HEALTHY Department or who fails to comply with the standards
VOLUNTARY DONORS ONLY! prescribed by the Department referred to in Section 9
• While donated blood is free, there are significant − IMPRISONMENT: not less than twelve (12) years and
costs associated with collecting, testing, preparing one (1) day nor more than twenty (20) years
components, labeling, storing and shipping; recruiting − FINE: not less than Fifty thousand pesos (P50,000)
and educating donors; and quality assurance. As a nor more than Five hundred thousand pesos
result, processing fees are charged to recover costs. (P500,000)
Processing fees for individual blood components vary • The Secretary may impose administrative sanctions
considerably. but not limited to fines, suspension, or revocation of
• The following are acceptable maximum allowable license to operate a blood banks/centers and to
processing fee for blood/components: Whole blood: recommend the suspension or revocation of the
Php 1,500.00; Pack Red Cells: Php 1,100.00; Fresh license to practice the profession when applicable.
Frozen Plasma: Php 700.00; Cryoprecipitate: Php • The head of the blood bank and the necessary
700.00; and Cryosupernate: Php 700.00. (AO 181 s. personnel under the heads direct supervision found
2002). responsible for dispensing, transfusing and failing
• Hospitals charge for any additional testing that may to dispose, within forty-eight (48) hours, blood
be required, such as the crossmatch, as well as for which have been proven contaminated with blood
the administration of the blood. transfusion transmissible diseases shall be
SECTION IX. REGULATION OF BLOOD SERVICES imprisoned for ten (10) years.
• It shall be unlawful for any person to establish and SECTION XIII. SEPARABILITY CLAUSE
operate a blood banks/centers unless it is registered SECTION XIV. REPEALING CLAUSE
and issued a license to operate by the Department • The Act shall supersede the Republic Act No. 1517
• No license shall be granted or renewed by the “Blood Bank Act” – The first act prior to R.A. No. 7719
Department for the establishment and operation SECTION XV. EFFECTIVITY
unless it complies with the standards prescribed by • This act shall take effect after fifteen (15) days
the Department following as publication in the Official Gazette or in
• No license shall be granted or renewed by the two (2) newspapers of general circulation
Department for the establishment and operation of a ADDITIONAL NOTE:
blood bank/center unless it complies with the • Administrative Order 2008-0008 is the implementing
standards prescribed by the Department. rules and regulations pursuant to R.A. 7719
• Such blood bank/center shall be under the CRITERIA FOR DONOR SELECTION:
management of a licensed and qualified physician • Age: 17-65 years old, ≤16 needs parents’ consent
duly authorized by the Department. • Weight: 50 kgs or 110 lbs
SECTION X. IMPORTATION OF BLOOD BANK, • Hemoglobin: ≥ 12.5 g/dL
EQUIPMENT, BLOOD BAGS AND REAGENTS • Hematocrit: ≥ 38%
• Equipment, blood bags and reagents used for the • Temperature: Oral temp not to exceed 37.5 C or 99.5
screening and testing donors, collection and F
processing and storage of blood shall be imported • Pulse: 50-100 beats /minute (lower pulse beat is
tax- and duty-free by the PNRC, blood banks and accepted for athletes)
hospitals participating actively in the National • Blood Pressure:
Voluntary Blood Services Program. − American Association of Blood Banking
• This provision shall be implemented by the rules and (AABB): 180 mmHg –systolic
regulations to be promulgated by the Department in 100 mmHg –diastolic
consultation and coordination with the Department of − Philippines: 90-160 mmHg –systolic
Finance. 60-100 mmHg –diastolic
SECTION XI. RULES AND REGULATION • Skin Lesions: Evidence of skin lesions (e.g. multiple
• The existing Revised Rules and Regulations puncture marks) is cause for indefinite deferral
Governing the Collection, Processing and Provision DONOR DEFERRAL
of Human Blood and the Establishment and • Permanent/Indefinite Deferral
Operation of Blood Banks shall remain in force unless
− High risk history of HIV/AIDS
amended or revised by the Secretary
− Male who have sex with male since 1977
− Intravenous drug abusers either past or present − Philippines: 12 weeks or three months
− Anyone who engaged in sex for money since 1977 • Six Weeks Deferral
− Hemophiliacs − Following a delivery of a baby
− Confirmed Positive test for HIV/AIDS − Philippines: 9 months after childbirth
− Symptoms of viral hepatitis after age 11 • One Month Deferral
− Donors implicated in a post-transfusion hepatitis − German measles(rubella) vaccination
− AIDS case − After cessation of the drug isotretinoin (Accutane) for
− Confirmed positives test for hepatitis C antibody acne treatment
(HCab) − After cessation of the drug finasteride (Proscar) for
− Confirmed positive test for Human T-cell lymphotropic the treatment of benign prostatic hyperplasia.
virus (HTLV) • Two Weeks Deferral
− Malignant solid tumors, except for basal cell − After vaccination with oral polio, measles(rubeola),
carcinoma of the skin and carcinoma insitu of the mumps or yellow fever
cervix − After immune reaction to smallpox vaccination
− Hematologic malignancies • 48 Hours Deferral
− Chemotherapeutic agents administered for − Whole blood donation deferred after hemapheresis
malignancy • 12-24 Hours
− Chronic cardiopulmonary, liver, or renal disease − After alcohol intake
− Serious abnormal bleeding tendencies
− Those who have taken the drug etretinate (Tegison) DOH Department Circular No. 2021-0102: Updating of
for the treatment of psoriasis (teratogenic) Timing of Blood Donation When Donors Receive
− History of babesiosis COVID-19 Vaccine in the A to Z Guide to Medical
− History of Chagas’ disease Assessment of Blood Donors
− Anyone who has ever received clotting factor • Per World Health Organization (WHO), the purpose
concentrate of donor selection is to assess the suitability of an
− Recipient of pituitary derived growth hormone (risk of individual to be a blood donor. This is to ensure that
transmitting Creutzfeld-jacob disease) blood donation is safe for the donor and the blood
− Recipient of cornea/dura mater transplant (risk of products derived from this donation are safe for the
transmitting Creutzfeld-jacob disease) recipients.
− Anyone who have taken insulin from cows (risk of • As COVID-19 continuously affects the world, one of
transmitting Mad cow disease) the breakthrough events is the availability of COVID-
• Temporary Deferral 19 vaccines. As the Philippines implements the “The
− Active disease under treatment such as cold, flu, National Deployment and Vaccination Plan for
tuberculosis, syphilis, infections, curable disease of COVID-19 Vaccines”, the National Voluntary Blood
the: heart, lung, kidney, liver and gastrointestinal Services Program (NVBSP) has taken into account
tract; treatment with antibiotics the need to update the existing guidelines in the
• Three Years Deferral timing of blood donation especially for blood donors
who received vaccination against COVID-19.
− Immigrant or refugee coming from an area considered
endemic for malaria, three years after departure, or • The NVBSP has recommended to update the list of
those who have had a diagnosis of malaria, three vaccines with the following deferral period of blood
years after becoming asymptomatic donation for individuals who have received a
vaccination against COVID-19:
• 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
REPUBLIC ACT NO. 4688
− Transfusion of blood components
− Transplant such as bone marrow or organ/tissue, − “CLINICAL LABORATORY ACT”
bone or skin graft. • An act regulating the operation and maintenance of
− Had accidental needle stick injury clinical laboratories and requiring the registration of
− History of syphilis or gonorrhea the same with the Department of Health, providing
− Leishmania risk (travel to Iraq in the last 3 years) penalty for the violation thereof, and for other
• Four Months/120 Days Deferral purposes.
− 120 days from recovery with clinical diagnosis, or • Approved on June 18, 1966
suspicion of West Nile Virus (WNV) infection • Signed by President Ferdinand E. Marcos
• Three Months Deferral • This act promulgates the rules and regulation to the
− Typhoid infection following reasons:
• Two Months Deferral − To protect
− Recent blood donation − To promote
− 56 days for allogenic donation
− Ensures the availability of clinical laboratories that are − Microbiology
properly managed with adequate resources, with − Molecular and Nuclear diagnostics
effective and efficient performance through the − Molecular biology
compliance with quality standards. − Cytogenetics
The following Administrative and Executive Orders • Applicant — refers to any natural juridical person,
were issued in relation to RA 4688: 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
Administrative Order No. 2021-0037 prescribed in this order.
− NEW RULES AND REGULATIONS GOVERNING • Department of Health - Permit to Construct (DOH-
THE REGULATION OF CLINICAL LABORATORIES PTC) — a permit issued by DOH through HFSRB or
IN THE PHILIPPINES Center for Health Development-Regulation, Licensing
ABBREVIATIONS and Enforcement Division (CHD-RLED) to an
• DOH-LTO: Department of Health - License to applicant who will establish and operate a hospital or
Operate other health facility, upon compliance with required
• DOH-PTC: Department of Health - Permit to documents prior to the actual construction of the said
Construct facility. It is also required for:
• HFSRB: Health Facilities and Services and − Hospitals and other health facilities with substantial
Regulatory Bureau alteration, expansion, renovation
• CHD-RLED: Center for Health Development- − Increase in the number of beds
Regulation, Licensing and Enforcement Division − Transfer of site
• OLRS: Online Licensing and Regulatory System − Additional services (add-ons) beyond their service
• OSSOLS: One-Stop Shop Online Licensing System capability
RATIONALE, OBJECTIVE AND SCOPE OF • External Quality Assessment Program (EQAP) —
APPLICATION a program where participating CL are given unknown
Rationale samples for analysis. The quality of performance of
• To align the laboratory procedures with the the CL shall be assessed through the closeness of its
requirements of AO 2020-0047 titled “Rules and results to the pre-determined value or reference value
Regulations Governing the Licensure of Primary Care generated by the participating CL through peer group
Facilities in thePhilippines.” analysis.
• To revise and update the minimum standards and • Initial Application — refer to applications by newly
technical requirements for licensing clinical constructed health facilities, or those with changes in
laboratories in the Philippines aligned with the main the circumstances of the facility, such as, but not
objective of Republic Act No. 11223 or the Universal limited to, change of ownership, transfer of site,
Health Care Act which is to guarantee access to increase in beds or for additional services beyond
quality and affordable health products, devices, their service capability and major alterations or
facilities and services renovations.
Objective • Mobile Clinical Laboratory (MCL) — a laboratory
• To ensure accountability of the laboratory on testing unit capable of performing limited CL
generation of accurate, precise and reliable diagnostic procedures. It moves from one testing site
laboratory results in a timely manner through to another, and it has a DOH-licensed CL as its main
continuous compliance laboratory.
Scope • National External Quality Assessment Scheme
• Shall apply to all individuals, agencies, partnerships (NEQAS) — an EQAP activity conducted by the
or corporations, whether private or government- National Reference Laboratories to assess the quality
owned, involved in the application for DOH license to ofperformance and accuracy of the results of
operate and those in the operation of diagnostic laboratories.
clinical laboratories in the Philippines • National Reference Laboratory (NRL) — the
DEFINITION OF TERMS highest level of laboratory in the country performing
• Clinical laboratory – a facility that is involved in the highly complex procedures, including confirmatory
pre-analytical, analytical, and post-analytical testing. It is the responsible entity for facilitating
procedures, where tests are done on specimens from NEQAS to ensure compliance to quality standards for
the human body to obtain information about the health regulation and licensing of all laboratories in the
status of a patient for the prevention, diagnosis and Philippines.
treatment of diseases. These tests include, but are
not limited the following disciplines:
− Anatomic pathology
− Clinical chemistry
− Clinical microscopy
− Endocrinology
− Hematology
− Immunology and Serology
 • 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
• Physician’s Office Laboratory (POL) — refers to a and related DOH issuances.
doctor’s office/clinic wherein CL examinations are • At the Central Office, the Director IV, or in his/her
performed for the purpose of monitoring the doctor’s absence or unavailability or when delegated, the
patients only, wherein no official results shall be Director III of HFSRB, shall approve the issuance of
issued. In this Order, POL within the premises of a the DOH-LTO of the CL.
DOH-regulated facility shall be under the supervision • At the CHD, the Director IV, shall approve the
of the CL. issuance of the DOH-LTO of the CL.
• Point of Care Testing (POCT) — refers to diagnostic • In the advent of new technologies or diagnostic
testing done at or near the site of patient care rather platforms that shall affect the current licensing
than in the CL. It may be in the emergency room, standards for CL, Department Circulars shall be
operating suites, wards, and ambulances. issued, as needed, as supplements to this Order.
• Satellite Clinical Laboratory (SCL) — refers to an • The CL shall be compliant with the prescribed
extension of the main CL located within the facility’s standards and requirements, Assessment Tool for
compound or premises. It shall have the same service Licensing Clinical Laboratories and other relevant
capability as the main laboratory. laws and issuances. These standards shall also apply
• Referral Tests — refers to CL tests that are either to MCL and SCL.
sent out or outsourced to other DOH-licensed CL with • The DOH-LTO may be revoked, suspended or
the same or higher service capability. modified in full or in part for any false statement by the
GENERAL GUIDELINES applicant, or as shown by the record of inspection or
• All CL shall secure DOH-LTO prior to its operation for a violation of, or failure to comply with any of the
and must comply with the minimum regulatory terms and conditions and provisions of these rules
standards and requirements at all times. and regulations.
• The DOH-LTO shall be secured from the DOH SPECIFIC GUIDELINES
regulatory office in accordance with DOH 1. Classification by Ownership
guidelines. a. Government: operated and maintained, partially or
• Only DOH-licensed institution-based CL may have a wholly, by the national government, a local
SCL which shall be located within the premises of government unit (provincial, city or municipal), any
the regulated health facility. other political unit or any department, division, board
• A DOH-licensed CL may have MCL services, or agency.
provided, they adhere to the standard testing b. Private: privately owned, established, and operated
protocols. with funds through donation, principal, investment or
• The DOH-licensed CL shall not perform any other means, by any individual, corporation,
examinations or testing beyond its authorized association or organization.
service capability. However, it may be allowed to 2. Classification by Institutional Character
offer laboratory services other than the respective a. Institution-based: a laboratory located within the
stipulated minimum services, such as but not limited premises and operates as part of a DOH licensed
to, MCL, SCL, confirmatory testing for Glucose-6- health facility.
Phosphate Dehydrogenase Deficiency, and Rapid b. Non-institution based: a laboratory that operates
HIV Diagnostic Algorithm (rHIVda), provided that the independently and is not attached to any DOH
additional services have been approved and licensed health facility.
indicated as add-on services in the DOH-LTO of the 3. Classification by Function
CL. a. Clinical Pathology: deals with the chemical and
• Unit/Section of health facilities performing diagnostic cellular analyses of blood and other body fluids
CL tests such as, but not limited to, arterial blood gas (includes, but not limited to, clinical chemistry, clinical
and/or Radioimmunoassay for thyroid function tests microscopy, toxicology, therapeutic drug monitoring,
and Prostate Specific Antigen shall be under the immunology and serology, hematology and
DOH-licensed CL. coagulation), identification and examination of
• The head of the CL shall be a pathologist certified by microbes and parasites
a professional organization recognized as the (bacteriology/parasitology/mycology/virology)
Accredited Professional Organizations/Accredited b. Anatomic Pathology: provides processing and
Integrated Professional Organizations of the examination of surgical specimens as to physical
Professional Regulation Commission. The head of appearance and microscopic structures of tissues
laboratory shall ensure the optimal overall operations such as, but not limited to, surgical pathology,
and maintenance of the CL and if applicable, of its cytopathology, immunohistochemistry techniques,
SCL and MCL. autopsies and forensic pathologies.
• There shall be an adequate number of competent c. Molecular Pathology: deals with the analysis of
personnel assigned in the different services provided certain genes, proteins and other molecules in
by the DOH-licensed CL, which includes the MCL, samples from organs, tissues of bodily fluids in order
SCL, remote collection activities, if applicable. to diagnose disease/ and or to guide the prevention
 and treatment of disease based on the principles, • The DOH-LTO shall be placed in an area that can be
techniques and tools of molecular biology as they are readily seen by the public, at all times
applied to diagnostic medicine in the laboratory. • For institution-based CL, the One-Stop Shop (OSS)
4. Classification by Service Capability Licensing System should be followed
a. Clinical Laboratory for Clinical and Anatomic Validity
Pathology • 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,
b. Clinical Laboratory for Anatomic Pathology only Licensing, and Enforcement Division (CHD-RLED)
provides services for any of the following, but not • Strictly enforce the provisions of this Order.
limited to cytology and histopathology. • Submit quarterly report on Suspension/Revocation/
c. Clinical Laboratory for Molecular Pathology only — Cease and Desist Order issued on CL not later than
provides services for genetics, the 15th day of the following month after the covered
immuno/hematopathology and infectious disease. quarter.
COVID-19 testing laboratories shall be covered by • Provide consultation and technical assistance to
another Order stakeholders in line with the regulation of CL.
PROCEDURAL GUIDELINES • Respond promptly to complaints relative to the
DOH Permit to Construct (DOH-PTC) operation of CL under its jurisdiction.
• Completely filled out application form for National Reference Laboratories (NRL)
(downloadable at www.hfsrb.doh.gov.ph), whether • Provide laboratory reference/referral services for
manual or online, shall be submitted to the DOH confirmatory testing.
regulatory offices • Train laboratory personnel and recognize other
• For construction of new CL and for renovation or training institutions.
expansion of existing CL, including change in • Maintain the National External Quality Assessment
ownership and transfer of location Scheme (NEQAS).
Certificate of Registration (COR) • Perform technical evaluation of reagents and
• Required for research and teaching laboratories diagnostic kits.
License to Operate (LTO) DOH-Licensed Clinical Laboratories
• Applicant should submit an accomplished application • Continuously comply with the rules and regulations,
form to HFSRB/CHD-RLED in accordance with the licensing standards and requirements for CL, as
current DOH guidelines, whether manual or through provided in this Order and related issuances.
the Online Licensing and Regulatory System (OLRS) • Participate in EQAP that may be administered by a
• The DOH-LTO is non-transferable and a new designated NRL or other local and international
application for DOH-LTO shall be required in case of EQAP approved by the DOH, surveys and other
change of ownership or transfer of location. activities that will be required from them by the DOH.
• Different branch(es) of a CL, even if owned by the • In times of Pandemic of Public Health Event, be
same entity shall secure separate DOH-LTO mandated to submit timely reports and data.
VIOLATIONS, SANCTIONS AND APPEAL • Essentially responsible for the operation of the entire
• A CL shall be sanctioned and penalized by the laboratory, its personnel, functions, and data, all of
HFSRB/CHD Director upon violation of any of these which shall meet the quality assurance criteria and
guidelines and its related issuances and laws, or upon regulatory requirements
committal (commission/omission) of prohibited acts • Shall oversee the operation of the CL and have
by the persons owning or operating the CL, and/or the administrative and technical supervision of the
persons under their authority. activities including the mobile clinical laboratories
• For non-institution-based CL that are not under the (MCL), remote collection activities, and point of care
OSSOLS, the following are the penalties and testing (POCT), if applicable.
sanctions that shall be imposed for the commission of • Shall supervise the staff in accordance with the
any of the violations in this Order and other relevant standards set by the Philippine Society of
issuances: Pathologists
− 1st offense: Stern warning • Shall visit once a month and at least twice a week of
− 2nd offense: Thirty thousand pesos (Php 30,000.00) supervisory calls and/or videoconferencing or at least
− 3rd offense: Fifty thousand pesos (Php 50,000.00) once a week physical visit. For hospital-based DOH
− 4th offense: Revocation of DOH-LTO licensed CL, it shall be once a week physical visit. The
• Any person who operates a CL without securing the visits shall have to be well documented.
necessary DOH-PTC and corresponding DOH-LTO • For Geographically Isolated and Disadvantaged
shall be issued a Cease-and-Desist Order (CDO) and Areas (GIDAs) with no clinical pathologists, as
shall pay the administrative penalty of Fifty thousand certified by the Philippine Society of Pathologists,
pesos (Php50,000.00). board certified Anatomic Pathologists or Physicians
• In case of complaints, the CL, upon receipt of such by with complete training in Clinical Laboratory Medicine,
HFSRB/CHD-RLED shall be given due process Quality Assurance and Laboratory Management, may
wherein an investigation shall be conducted and the head one primary DOH licensed CL.
appropriate sanctions for its violation/s. A 60-day Registered Medical Technologist (RMT)
preventive suspension may be given to the CL during • There shall be an adequate number of full-time RMTs
the investigation depending on the seriousness of the conduct the laboratory procedures, including those
violation. assigned in MCL. The number of staff shall depend
• May appeal to the Head of the Health Regulation on the workload and the services being provided.
Team (HRT). The decision of the Head of the HRT, if • There shall be staff development and continuing
still contested may be brought on a final appeal to the education program at all levels of organization to
Secretary of Health, whose decision shall be final and upgrade the knowledge, attitude and skills of staff.
executory. • There shall be a designated Biosafety and Biosecurity
• CL with revoked licenses can only re-apply after one Officer in-charge primarily of the risk assessment of
year from the date of LTO revocation. the DOH licensed CL.
• Any person authorized or licensed to conduct clinical Support Staff
laboratory tests, who issues false or fraudulent • There shall be an adequate number of support staff
laboratory test results knowingly, willfully or through such as, but not limited to laboratory technician,
gross negligence shall not be allowed to own, laboratory aide, encoders, and receptionists when
manage, operate, or be an analyst of any DOH- applicable.
licensed CL. POCT Coordinator — if applicable
LICENSING STANDARDS FOR CLINICAL • A senior staff from the CL shall be designated as a
LABORATORY POCT coordinator who shall have the following
Physical Plant functions, but not limited to:
• The CL shall conform to all applicable local and − Recommends procedures that will ensure the quality
national regulations for the construction, renovation, of results of POCT in consultation with the
maintenance and repair of CL. pathologist.
• The laboratory shall conform to the required space for − Ensures that POCT machines/device and kits are
the conduct of its activities. Personnel, fixtures, properly maintained.
equipment, sink, etc. shall also be considered. − Supervises the operators of POCT device/machine.
• There shall be well-ventilated, lighted, clean, safe and − Ensures that the operators have appropriate trainings
functional areas based on the services provided. and checks the competency of the operators
• There shall be a program of proper maintenance and regularly.
monitoring of physical plant and facilities. − Ensures that quality control (QC) is implemented and
• There shall be policy guidelines on laboratory reviews POCT QC results periodically, depending on
biosafety and biosecurity which includes risk the number of tests.
assessment that will serve as the basis of biosafety POCT Operator — if applicable
level required for the specific CL. • The designated operator of the POCT
• There shall be an area for confirmatory testing for device/machine and testing kits shall have the
Rapid HIV Diagnostic Algorithm and Glucose-6- following functions, but not limited to:
Phosphate Dehydrogenase (G6PD) Deficiency which − Ensures accurate results of POCT.
may be a section, unit, or division integrated in a DOH − Ensure that POCT machines/device and kits are
licensed CL, if applicable. properly maintained and stored.
PERSONNEL − Run tests on quality control at least once each day or
Head of The Laboratory (HOL) as recommended by the manufacturer.
• Shall be a competent and experienced professional, − Initially, implements quality assurance program or
with a specialized skill set related to and proportionate contact the manufacturer’s application specialist for
to the laboratory category, to ensure that the assistance, when a POCT machine/device is not
laboratory runs efficiently
 properly functioning, or the control sample is in out- accountabilities of every personnel working in the
of-control range. laboratory.
− Reports to the supervising CL any untoward incidents • There shall be documented technical procedures for
or problems services provided in each section of the laboratory,
MCL Personnel including MCL and POCT, which will ensure the
• MCL shall has its own set of personnel, which quality of laboratory results.
includes the following but not limited to: • There shall be a risk assessment for every section in
− Registered Medical Technologist — number will the CL.
depend on the anticipated workload. Communication and Records Management
− Support staff such as, but not limited to, driver and • The CL shall maintain and ensure the confidentiality
laboratory technician. of all records.
EQUIPMENT/INSTRUMENTS/REAGENTS/GLASSWA • There shall be procedures for the receipt and
ES/SUPPLIES performance of routine and STAT requests for
There shall be: laboratory examinations.
• Available and operational • There shall be procedures for the reporting of results
equipment/machines/devices to provide the of routine and STAT laboratory examinations,
laboratory examination that the laboratory is licensed including critical values that would impact on patient
for. care.
• A calibration, preventive maintenance and repair • All results shall be released in accordance with DOH
program for every guidelines.
equipment/machines/instruments/device in the DOH • All laboratory reports on various examinations of
licensed CL. specimens shall bear the name, PRC registration
• A contingency plan in case of number, and original signature of the registered
equipment/machines/devices breakdown and medical technologist(s) who performed the laboratory
malfunction. examinations, and the pathologist who shall be
• Adequate available reagents, glassware and supplies accountable for the reliability of the results.
for the laboratory examinations. • There shall be a policy guideline on the use of digital
• An inventory control of the reagents, glassware and signature. The use of digital signature for laboratory
supplies, reagents, glassware and supplies shall be results shall be permitted only if properly
properly stored under the required conditions. authenticated by the Department of Information and
• Machines/devices, reagents and test kits that are Communication Philippine National Public
used in the CL and MCL as well as POCT shall be Infrastructure. The use of digital signature shall also
approved by the Philippine Food and Drug be in accordance with the provisions of the E-
Administration and validated by the proper Commerce Law.
government institutions (e.g. National Reference • There shall be procedures for the reporting of
Laboratory). workload, quality control, inventory control, work
• The MCL shall have its own set of functional, and schedule and assignments.
operational equipment, as well as its own set of • There shall be procedures for the reporting and
supplies. analysis of incidents, adverse events, and in handling
Service Delivery complaints.
• All CL shall ensure that the service being delivered to • The retention of laboratory documents, records,
patients must comply with the standards and other slides and specimens shall be in accordance to the
related relevant issuances. standards promulgated by the DOH or by competent
• Mobile Clinical Laboratory: collection site/area for authorities for such purposes.
MCL shall be located within the same region, at a • The operating hours of the CL shall be known to its
maximum of one hundred (100) kilometer radius, from clients.
the address of the DOH licensed CL. • The CL which supervises the POCT shall have a
• Aside from specimen collection for different tests master list of the following, but not limited to a. name
within the service capability of the main CL, the MCL and designation of operators, and b. POCT machines,
shall be allowed to perform the following on-site tests instruments and kits.
which shall be declared in the LTO of the main CL: QUALITY IMPROVEMENT
− Urinalysis • There shall be an Internal Quality Assurance Program
− Fecalysis which shall include:
− Pregnancy Test (lateral flow) − An Internal Quality Control Program for technical
− Basic Serologic Test using Rapid Test Kits — procedures.
Dengue, Screening of Hepatitis B, RPR/Syphilis Test, − An Internal Quality Assurance Program for inputs,
and HIV processes and outputs.
• Specimen collected for another test, not mentioned − A Continuous Quality Improvement Program covering
above should be properly handled and transported. all aspects of laboratory performance.
Serum blood samples for chemistry testing must be − The CL shall participate in External Quality
separated within four (4) hours from the time of Assessment Program (EQAP) that may be
collection. administered by a designated NRL or other local and
INFORMATION MANAGEMENT international EQAP approved by the DOH.
Administrative Policies and Procedures REFERRAL OF LABORATORY EXAMINATIONS
• The CL shall have written policies and procedures for • The referral laboratory must be a DOH-licensed CL.
the provision of laboratory services, the operation and They shall have a Memorandum of Agreement (MOA)
maintenance of the CL, which includes satellite with the referring CL and shall be responsible for the
laboratories, MCL and POCT, and shall include 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.