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Psalms 139
1. O Lord, thou hast searched me, and known me.
2. Thou knowest my downsitting and mine
uprising, thou understandest my
thought afar off.
3. Thou compassest my path and my lying down, and art acquainted with
all my ways.
4. For there is not a word in my tongue, but, lo, O Lord,
thou knowest it altogether.
5. Thou hast beset me behind and before, and laid thine
hand upon me.
6. Such knowledge is too wonderful for me; it is high,
I cannot attain unto it.
7. Whither shall I go from thy spirit? or whither
shall I flee from thy presence?
8. If I ascend up into heaven, thou art there: if I make my bed in hell,
behold, thou art there.
9. If I take the wings of the morning, and dwell in the uttermost parts of
the sea;
10. Even
there shall thy hand lead me, and thy right hand shall hold
me.
11. If I
say, Surely the darkness shall cover
me; even the night shall be light about me.
12. Yea,
the darkness hideth not from thee;
but the night shineth as the day:
the darkness and the light are both alike to thee.
13. For
thou hast possessed my reins: thou hast covered me in my mother's
womb.
14. I will
praise thee; for I am fearfully and wonderfully made: marvellous are thy works; and that my soul knoweth right well.
15. My substance
was not hid from thee, when I was made in secret, and curiously
wrought in the lowest parts of the earth.
16. Thine
eyes did see my substance, yet being unperfect;
and in thy book all my members were written, which in continuance
were fashioned, when as yet there was none of them.
17. How
precious also are thy thoughts unto me, O God! how
great is the sum of them!
18. If I
should count them, they are more in number than the sand:
when I awake, I am still with thee.
19. Surely
thou wilt slay the wicked, O God: depart from me therefore,
ye bloody men.
20. For
they speak against thee wickedly, and thine enemies take thy
name in vain.
21. Do not
I hate them, O Lord, that hate thee?
and am not I grieved with those that rise up against thee?
22. I hate
them with perfect hatred: I count them mine enemies.
23. Search
me, O God, and know my heart: try me, and know my thoughts:
24. And
see if there be any wicked way in
me, and lead me in the way everlasting.
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Republic Act No. 9288
An Act Promulgating A Comprehensive
Policy And A National System For Ensuring Newborn Screening
Article 1 General Provisions
Section 1. Short Title. This Act shall
be known as the "Newborn Screening Act of 2004."
Sec. 2. Declaration of Policy. It
is the policy of the State to protect and promote the right to
health of the people, including the rights of children to survival
and full and healthy development as normal individuals. In pursuit
of such policy, the State shall institutionalize a national newborn
screening system that is comprehensive, integrative and sustainable,
and will facilitate collaboration among government and non-government
agencies at the national and local levels, the private sector,
families and communities, professional health organizations, academic
institutions, and non-governmental organizations. The National
Newborn Screening System shall ensure that every baby born in
the Philippines is offered the opportunity to undergo newborn screening
and thus be spared from heritable conditions that can lead to
mental retardation and death if undetected and untreated.
Sec. 3. Objectives. The objectives
of the National Newborn Screening System are:
1. To ensure
that every newborn has access to newborn screening for certain
heritable conditions that can result in mental retardation, serious
health complications or death if left undetected and untreated;
2. To establish and integrate a sustainable newborn screening
system within the public health delivery system;
3. To ensure
that all health practitioners are aware of the advantages of newborn
screening and of their respective responsibilities in offering
newborns the opportunity to undergo newborn screening; and
4. To ensure that parents recognize their responsibility
in promoting their child’s right to health and full development,
within the context of responsible parenthood, by protecting their
child from preventable causes of disability and death through
newborn screening.
Article 2 Definition Of Terms
Sec. 4. Definitions. Under this Act,
the following terms shall have the meanings respectively given
to them below:
1. Comprehensive
Newborn Screening System means a newborn screening system that
includes, but is not limited to, education of relevant stakeholders;
collection and biochemical screening of blood samples taken from
newborns; tracking and confirmatory testing to ensure the accuracy
of screening results; clinical evaluation and biochemical/medical
confirmation of test results; drugs and medical/surgical management
and dietary supplementation to address the heritable conditions;
and evaluation activities to assess long term outcome, patient
compliance and quality assurance.
2. Follow-up means the
monitoring of a newborn with a heritable condition for the purpose
of ensuring that the newborn patient complies fully with the medicine
of dietary prescriptions.
3. Health institutions
mean hospitals, health infirmaries, health centers, lying-in centers
or puericulture centers with obstetrical
and pediatric services, whether public or private.
4. Healthcare practitioner
means physicians, nurses, midwives, nursing aides and traditional
birth attendants.
5. Heritable
condition means any condition that can result in mental retardation,
physical deformity or death if left undetected and untreated and
which is usually inherited from the genes of either or both biological
parents of the newborn.
6. NIH means the
National Institute of Health
7. Newborn means
a child from the time of complete delivery to 30 days old.
8. Newborn Screening
means the process of collecting a few drops of blood from the
newborn onto an appropriate collection card and performing biochemical
testing for determining if the newborn has a heritable condition.
9. Newborn Screening Center means a facility equipped with a newborn screening
laboratory that complies with the standards established by the
NIH and provides all required laboratory tests and recall/follow-up
programs for newborns with heritable conditions.
10. Newborn Screening
Reference Center means the central facility at the NIH that defines
testing and follow-up protocols, maintains an external laboratory
proficiency testing program, oversees the national testing database
and case registries, assists in training activities in all aspects
of the program, oversees content of educational materials and
acts as the Secretariat of the Advisory Committee on Newborn Screening.
11. Parent education
means the various means of providing parents or legal guardians information about newborn screening.
12. Recall means
a procedure for locating a newborn with a possible heritable condition
for purposes of providing the newborn with appropriate laboratory
to confirm the diagnosis and, as appropriate, provide treatment.
13. Treatment means
the provision of prompt, appropriate and adequate medicine, medical,
and surgical management or dietary prescription to a newborn for
purposes of treating or mitigating the adverse health consequences
of the heritable condition.
Article 3 Newborn Screening
Sec. 5. Obligation to Inform. Any
health practitioner who delivers, or assists in the delivery,
of a newborn in the Philippines shall, prior to delivery, inform the parents or legal
guardian of the newborn of the availability, nature and benefits
of newborn screening. Appropriate notification and education regarding
this obligation shall be the responsibility of the Department
of Health (DOH).
Sec. 6. Performance of Newborn Screening.
Newborn screening shall be performed after twenty-four (24) hours
of life but not later than three (3) days from complete delivery
of the newborn. A newborn that must be placed in intensive care
in order to ensure survival may be exempted from the 3-day requirement
but must be tested by seven (7) days of age. It shall be the joint
responsibility of the parent(s) and the practitioner or other
person delivering the newborn to ensure that newborn screening
is performed. An appropriate informational brochure for parents
to assist in fulfilling this responsibility shall be made available
by the Department of Health and shall be distributed to all health
institutions and made available to any health practitioner requesting
it for appropriate distribution.
Sec. 7. Refusal to be Tested. a parent or legal guardian may refuse testing on the
grounds of religious beliefs, but shall acknowledge in writing
their understanding that refusal for testing places their newborn
at risk for undiagnosed heritable conditions. A copy of this refusal
documentation shall be made part of the newborn’s medical record
and refusal shall be indicated in the national newborn screening
database.
Sec. 8. Continuing Education, Re-education
and Training Health Personnel. The DOH, with the assistance
of the NIH and other government agencies, professional societies
and non-government organizations, shall: (i)
conduct continuing information, education, re-education and training
programs for health personnel on the rationale, benefits, procedures
of newborn screening; and (ii) disseminate information materials
on newborn screening at least annually to all health personnel
involved in material and pediatric care.
Sec. 9. Licensing and Accreditation.
The DOH and the Philippine Health Insurance Corporation (PHIC)
shall require health institutions to provide newborn screening
services as a condition for licensure or accreditation.
Article 4 Implementation
Sec. 10. Lead Agency. The DOH shall
be the lead agency in implementing this Act. For purposes of achieving
the objectives of this Act, the DOH shall:
1. Establish
the Advisory Committee on Newborn Screening:
2. Develop the implementing
rules and regulations for the immediate implementation of a nationwide
newborn screening program within one hundred eight (180) days
from the enactment of this Act;
3. Coordinate with
the Department of the Interior and Local Government (DILG) for
implementation of the newborn screening program;
4. Coordinate with
the NIH Newborn Screening Reference Center for the accreditation of Newborn Screening Centers
and preparation of defined testing protocols and quality assurance
programs.
Sec. 11.
Advisory Committee on Newborn Screening.
To ensure sustained inter-agency collaboration, the Advisory Committee
on Newborn Screening is hereby created and made an integral part
of the Office of the Secretary of the DOH. The Committee shall
review annually and recommend conditions to be included in the
newborn screening panel of disorders; review and recommend the
newborn screening fee to be charged by Newborn Screening Centers;
review the report of the Newborn Screening Reference Center on the quality assurance of the National Screening
Centers and recommend corrective measures as deemed necessary.
The Committee shall be composed of eight (8) members,
including the Secretary of Health who shall act as Chairman. The
other members of the Committee shall be as follows: (i) the Executive Director of the NIH, who shall act as Vice
Chairperson; (ii) an Undersecretary of the DILG; (iii) the Executive
Director of the Council for the Welfare of Children (iv) the Director
of the Newborn Screening Reference Center; and (v) 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. The three (3) representatives
shall be appointed for a term of three (3) years, subject to their
being reappointed for additional three (3) years period for each
extension.
The Committee shall meet at least twice a year. The
NIH shall serve as the Secretariat of the Committee.
Sec. 12. Establishment and Accreditation
of Newborn Screening Centers. The DOH shall ensure that
Newborn Screening Centers are strategically located in order to
be accessible to the relevant public and provide services that
comply with the standards approved by the Committee upon the recommendation
of the NIH. No Newborn Screening Center shall be allowed to operate unless it has been duly
accredited by the DOH based on the standards set forth by the
Committee. At a minimum, every Newborn Screening Center shall:
(i) have a certified laboratory performing
all tests included in the newborn screening program, (ii) have
a recall/follow up programs for infants found positive for any
and all of the heritable conditions; (iii) be supervised and staffed
by trained personnel who have been duly qualified by the NIH;
and (iv) submit to periodic announced or unannounced inspections
by the Reference Center in order to evaluate and ensure quality
Newborn Screening Center performance.
Sec. 13. 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.
Sec. 14. Quality Assurance. The NIH Newborn Screening Reference Center shall be responsible for drafting and ensuring good
laboratory practice standards for newborn screening centers, including
establishing an external laboratory proficiency testing and certification
program. It shall also act as the principal repository of technical
information relating to newborn screening standards and practices,
and shall provide technical assistance to newborn screening centers
needing such assistance.
Sec. 15. 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. It shall submit reports annually
to the Committee and to the DOH on the status of and relevant
health information derived from the database. A plan for long-term
outcome evaluation of newborn screening utilizing the cases registries
shall be developed within one (1) year of passage of this Act
by the NIH Newborn Screening Reference Center in consultation with the Advisory Committee on Newborn
Screening. Implementation of this plan shall become a responsibility
of the Advisory Committee on Newborn Screening.
Sec. 16. Newborn Screening Fees The PHIC shall include cost
of newborn screening in its benefits package. The newborn screening
fee shall be applied to, among others, testing costs, education,
sample transport, follow-up and reasonable overhead expenses.
To ensure sustainability of the National System for
Newborn Screening, the newborn screening fee shall be divided
and set aside for the following purposes; at least four percent
(4%) to the DOH’s Centers for Health
Development or its future equivalent to be spent solely for follow-up
services, education and other activities directly related to the
provision of newborn screening services; at least four percent
(4%) to the Newborn Screening Centers for human resource development
and equipment maintenance and upgrading; at least four percent
(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.
Article 5 Final Provisions
Sec. 17. Repealing Clause. All general
and special laws, decrees, executive orders, proclamations and
administrative regulations, or any parts thereof, which are inconsistent
with this Act are hereby repealed or modified accordingly.
Sec. 18. Separability. If, for any reason
or reasons, any party of provisions of this Act shall be declared
or held to be unconstitutional or invalid, other provision or
provisions hereof which are not affected thereby shall continue
to be in full force and effect.
Sec. 19. Effectivity. This Act shall
take effect fifteen (15) days after its publication in at least
two (2) newspapers of general circulation.
Approved: April 07,
2004
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