MEDTECH LAWS AND BIOETHICS

College of Medical Technology

NEWBORN SCREENING

Overview SECTION 2. DECLARATION OF POLICY

● Newborn screening is a public
health initiative that identifies ● The policy of the State to protect
genetic, metabolic, or and promote the right to health of
developmental disorders that may the people, including the rights of
lead to mental retardation or even children to survival and full and
death. This early diagnosis allows healthy development as normal
for timely intervention and therapy, individuals.
preventing long-term problems and
improving prognosis. ● The National Newborn Screening
System shall ensure that every
● The screening panel varies across baby born in the Philippines is
countries and regions.The offered the opportunity to undergo
procedure involves a blood test newborn screening thus, be spared
taken from the baby's heel after 24 from heritable conditions that can
hours, blotting on a special lead to mental retardation and
absorbent filter card, and sent to death if undetected and untreated.
Newborn Screening Centers (NSC)
for testing. SECTION 3: OBJECTIVES

● The objectives of the National

Republic Act No. 9288
(April 7, 2004) Newborn Screening System are:

1. To ensure that every newborn has

“AN ACT PROMULGATING A
access to newborn screening for
COMPREHENSIVE POLICY AND A
certain heritable conditions that can
NATIONAL SYSTEM FOR ENSURING
result in mental retardation, serious
NEWBORN SCREENING”
health complications or death if left
undetected and untreated;
● Be it enacted by the Senate and
2. To establish and integrate a
House of Representatives of the
sustainable newborn screening
Philippines in Congress assembled:
system within the public health
delivery system;
ARTICLE 1
3. To ensure that all health
GENERAL PROVISIONS practitioners are aware of the
advantages of newborn screening
SECTION 1. SHORT TITLE and of their respective
responsibilities in offering newborns
● This Act shall be known as the the opportunity to undergo newborn
"Newborn Screening Act of 2004.” screening; and
4. To ensure that parents recognize
their responsibility in promoting
their child's right to health and full

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 development, within the context of 5. NIH means the National Institute
responsible parenthood, by of Health.
protecting their child from 6. Newborn means a child from the
preventable causes of disability and time of complete delivery to 30 days
death through newborn screening. old.
7. Newborn Screening means the
ARTICLE 2 process of collecting a few drops of
DEFINITION OF TERMS blood
from the newborn onto an
SECTION 4 : DEFINITION OF TERMS appropriate collection card and
performing
● Under this Act, the following terms biochemical testing for determining
shall have the meanings if the newborn has a heritable
respectively given to them below: condition.
8. Newborn Screening Center
The Comprehensive Newborn Screening means a facility equipped with a
System involves education, blood sample newborn
collection, testing, clinical evaluation, screening laboratory that complies
medication management, dietary with the standards established by
supplementation, and evaluation activities the
to assess long-term outcomes, patient NIH and provides all required
compliance, and quality assurance. laboratory tests and recall/follow-up
programs
1. Follow-up means the monitoring of for newborns with heritable
a newborn with a heritable condition conditions.
for the purpose of ensuring that the 9. The Newborn Screening
newborn patient complies fully with Reference Center at the NIH is
the medicine or dietary responsible for
prescriptions. defining testing protocols,
2. Health institutions mean maintaining an external proficiency
hospitals, health infirmaries, health program,
centers, lying-in centers or overseeing the national testing
puericulture centers with obstetrical database, and acting as the
and pediatric services, whether Secretariat of the
public or private. Advisory Committee on Newborn
3. Healthcare practitioner means Screening.
physicians, nurses, midwives, 10. Parent education means the
nursing aides and traditional birth various means of providing parents
attendants. or legal
4. Heritable condition means any guardians information about
condition that can result in mental newborn screening.
retardation, physical deformity or 11. Recall means a procedure for
death if left undetected and locating a newborn with a possible
untreated.and which is usually heritable condition for purposes of
inherited from the genes of either or providing the newborn with
both biological parents of the appropriate
newborn.

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 laboratory testing to confirm the to ensure that newborn screening is
diagnosis and, as appropriate, performed.
provide
treatment. ● Appropriate informational brochures
12. Treatment means the provision of for parents shall be made available
prompt, appropriate and adequate by the DOH and shall be distributed
medicine, medical and surgical to all health institutions and to any
management or dietary prescription health practitioner requesting it for
to a appropriate distribution.
newborn for purposes of treating or
mitigating the adverse health SECTION 7: REFUSAL TO BE TESTED
consequences of the heritable
condition. ● A parent or legal guardian may
refuse testing on the grounds of
ARTICLE 3 religious beliefs, but shall
NEWBORN SCREENING acknowledge in writing their
understanding that refusal for
SECTION 5 : OBLIGATION TO INFORM testing places their newborn at risk
● Any health practitioner who for undiagnosed heritable
delivers, or assists in the delivery, conditions.
of a newborn in the Philippines
shall, prior to delivery, inform the ● A copy of this refusal
parents or legal guardian of the documentation shall be made part
newborn of the availability, nature of the newborn's medical record
and benefits of newborn screening and refusal shall be indicated in the
national newborn screening
● Appropriate notification and database.
education regarding this obligation
shall be the responsibility of the SECTION 8: CONTINUING EDUCATION,
Department of Health (DOH). RE-EDUCATION, AND TRAINING OF
HEALTH PERSONNEL
SECTION 6: PERFORMANCE OF
NEWBORN SCREENING ● The DOH, with the assistance of
the NIH and other government
● Shall be performed after twenty-four agencies, professional societies
(24) hours of life but not later than and non-government organizations,
three (3) days from complete shall:
delivery of the newborn. A newborn
that must be placed in intensive (i) conduct continuing information,
care in order to ensure survival may education, re education and training
be exempted from the 3-day programs for health personnel on the
requirement but must be tested by rationale, benefits,procedures of newborn
seven (7) days of age. screening; and
(ii) disseminate information materials on
● It shall be the joint responsibility of newborn screening at least annually to all
the parent(s) and the practitioner or health personnel involved in maternal and
other person delivering the newborn pediatric care.

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SECTION 9: LICENSING AND Secretary of the DOH. The
ACCREDITATION Committee shall review annually
and recommend conditions to be
● The DOH and the Philippine Health included in the newborn screening
Insurance Corporation (PHIC) shall panel of disorders; review and
require health institutions to provide recommend the newborn screening
newborn screening services as a fee to be charged by Newborn
condition for licensure or Screening Centers; review the
accreditation. report of the Newborn Screening
Reference Center on the quality
ARTICLE 4 assurance of the National
IMPLEMENTATION Screening Centers and recommend
corrective measures as deemed
SECTION 10: LEAD AGENCY necessary.

● The DOH shall be the lead agency SECTION 12 : ESTABLISHMENT AND

in implementing this Act. For ACCREDITATION OF NEWBORN
purposes of achieving the SCREENING CENTERS
objectives of this Act, the DOH
shall: ● The DOH must strategically locate
Newborn Screening Centers to
1. Establish the Advisory Committee ensure accessibility and compliance
Newborn Screening with NIH-recommended standards.
2. Develop the implementing rules and Centers must be accredited, have a
regulations for the immediate certified laboratory, have
implementation of a nationwide recall/follow-up programs, be
newborn screening program within supervised by qualified personnel,
one hundred eight (180) days from and submit to periodic inspections
the enactment of this Act; by the Reference Center to ensure
3. Coordinate with the Department of quality performance
the Interior and Local Government
(DILG) for implementation of the SECTION 13: ESTABLISHMENT OF
newborn screening program; NEWBORN SCREENING REFERENCE
4. Coordinate with the NIH Newborn CENTER
Screening Reference Center for the
accreditation of Newborn Screening ● The NIH shall establish a Newborn
Centers and preparation of defined Screening Reference Center, which
testing protocols and quality shall be responsible for the national
assurance programs. testing database and case
registries, training, technical
SECTION 11: ADVISORY COMMITTEE assistance and continuing
ON NEWBORN SCREENING education for laboratory staff in all
Newborn Screening Centers.
● To ensure sustained inter-agency
collaboration, the Advisory SECTION 14: QUALITY ASSURANCE
Committee on Newborn Screening
is hereby created and made an ● The NIH Newborn Screening
integral part of the Office of the Reference Center shall be

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 responsible for drafting and package. The newborn screening
ensuring good laboratory practice fee shall be applied to, among
standards for newborn screening others, testing costs,education,
centers, including establishing an sample transport, follow-up and
external laboratory proficiency reasonable overhead expenses.
testing and certification program. It
shall also act as the principal ● The National System for Newborn
repository of technical information Screening will be divided into four
relating to newborn screening categories: 4% for the DOH's
standards and practices, and shall Centers for Health Development,
provide technical assistance to 4% for Newborn Screening
newborn screening centers needing Centers, 4% for the NIH Newborn
such assistance. Screening Reference Center, and
4% for operational and other
SECTION 15: DATABASE expenses of the Newborn
Screening Center.
● All Newborn Screening Centers
shall coordinate with the NIH ARTICLE 5
Newborn Screening Reference FINAL PROVISION
Center for consolidation of patient
databases. The NIH Newborn SECTION 17. REPEALING CLAUSE
Screening Reference Center shall
maintain a national database of ● All general and special laws,
patients tested and a registry for decrees, executive orders,
each condition. It shall submit proclamations and administrative
reports annually to the Committee regulations or any parts thereof,
and to the DOH on the status of which are inconsistent with this Act
and relevant health information are hereby repealed or modified
derived from the database. accordingly.

● A plan for long-term outcome SECTION 18. SEPARABILITY

evaluation of newborn screening
utilizing the cases registries shall be ● If, for any reason or reasons, any
developed within one (1) year of part of provisions of this Act shall
passage of this Act by the NIH be declared or held to be
Newborn Screening Reference unconstitutional or invalid, other
Center in consultation with the provisions or provisions hereof
Advisory Committee on Newborn which are noT affected thereby
Screening. Implementation of this shall continue to be in full force and
plan shall become a responsibility effect.
of the Advisory Committee on SECTION 19. EFFECTIVITY
Newborn Screening.
● This Act shall take effect fifteen (15)
SECTION 16: NEWBORN SCREENING days after its publication in at least
FEES two (2) newspapers of general
circulation.
● The PHIC shall include the cost of
newborn screening in its benefits APPROVED AND SIGNED BY:

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 ● Franklin M. Drilon- President of 6. What is the Title of Section 14?
the Senate (QUALITY ASSURANCE)
● Jose De Venecia Jr.- Speaker of 7. What is the Title of Section 7?
the House of Representatives (REFUSAL TO BE TESTED)
8. What is the Title of Section 5?
This Act which is a consolidation of Senate (OBLIGATION TO INFORM)
No. 2707 and House Bill No. 6625 was 9. Who is the President of the Senate who
finally passed by the Senate and the Approved and Signed the RA. 9288?
House of Representatives on February 2, (Franklin M. Drilon)
2004 and February 5, 2004, respectively. 10. Number of Sections of RA. 9288. (19
sections)
● OSCAR G. YABES- Secretary of 11. How many Articles does the RA. 9288
the Senate have? (5 articles)
● ROBERTO P. NAZARENO- 12. True
Secretary General House of 13. True
Representatives 14. True
15. True
Date of approved : April 7, 2004
President of the Philippines : Gloria
Macapagal - Arroyo

SUMMARY

19 Sections
5 Articles :
❖ Article 1: General Provision
❖ Article 2: Definition of Terms
❖ Article 3: Newborn Screening
❖ Article 4: Implementation
❖ Article 5: Final Provision

1. Philippine President who signed the

RA. 9288. (GMA)
2. A simple procedure to find out if a
baby has a congenital disorder that
may lead to mental retardation or
even death if left untreated.
(NEWBORN SCREENING)

3. The _____ acts as the lead agency in

the implementation of the Law to ensure
the normal growth and development of the
affected individual. DOH
4. Date of approval of RA. 9288. (April 7
2004)
5. Title of RA. 9288 (Newborn Screening
Act of 2004)