Newborn Screening Act policy and system

State policy and national objectives

Section 2 declares State policy to protect and promote the right to health of the people, including the rights of children to survival and full and healthy development.
Section 2 institutionalizes a national newborn screening system that is comprehensive, integrative and sustainable and that facilitates collaboration among government and non-government agencies at national and local levels, the private sector, families and communities, professional health organizations, academic institutions, and non-governmental organizations.
Section 2 ensures that every baby born in the Philippines is offered the opportunity to undergo newborn screening to spare the baby from heritable conditions that can lead to mental retardation and death if undetected and untreated.
Section 3 sets objectives that include ensuring access to newborn screening for heritable conditions that can result in mental retardation, serious health complications or death if left undetected and untreated.
Section 3 establishes and integrates a sustainable newborn screening system within the public health delivery system.
Section 3 ensures health practitioners are aware of newborn screening advantages and of their responsibilities in offering newborn screening opportunities.
Section 3 ensures parents recognize their responsibility in protecting their child from preventable causes of disability and death through newborn screening, within responsible parenthood.

Core definitions and key concepts

Section 4(1) defines “Comprehensive Newborn Screening System” to include: education of stakeholders; collection and biochemical screening of blood samples; tracking and confirmatory testing for screening accuracy; clinical evaluation and biochemical/medical confirmation; drugs and medical/surgical management and dietary supplementation; and evaluation activities assessing long-term outcome, patient compliance, and quality assurance.
Section 4(2) defines “Follow-up” as monitoring a newborn with a heritable condition to ensure full compliance with medicine or dietary prescriptions.
Section 4(3) defines “Health institutions” as hospitals, health infirmaries, health centers, lying-in centers, or puericulture centers with obstetrical and pediatric services, whether public or private.
Section 4(4) defines “Healthcare practitioner” as physicians, nurses, midwives, nursing aides, and traditional birth attendants.
Section 4(5) defines “Heritable condition” as any condition that can result in mental retardation, physical deformity, or death if left undetected and untreated and is usually inherited from the genes of either or both biological parents of the newborn.
Section 4(6) defines “NIH” as the National Institute of Health.
Section 4(7) defines “Newborn” as a child from complete delivery to 30 days old.
Section 4(8) defines “Newborn Screening” as collecting a few drops of blood onto an appropriate collection card and performing biochemical testing to determine whether the newborn has a heritable condition.
Section 4(9) defines “Newborn Screening Center” as a facility with a newborn screening laboratory meeting NIH standards and providing all required tests and recall/follow-up programs for newborns with heritable conditions.
Section 4(10) defines “Newborn Screening Reference Center” as the central NIH facility that defines testing and follow-up protocols, maintains external laboratory proficiency testing, oversees the national testing database and case registries, assists in training, oversees educational materials, and acts as Secretariat of the Advisory Committee on Newborn Screening.
Section 4(11) defines “Parent education” as providing parents or legal guardians information about newborn screening.
Section 4(12) defines “Recall” as locating a newborn with a possible heritable condition for purposes of providing confirmatory laboratory testing and, as appropriate, treatment.
Section 4(13) defines “Treatment” as prompt, appropriate and adequate medicine, medical and surgical management, or dietary prescription to treat or mitigate adverse consequences of the heritable condition.

Mandatory informing and performance duties

Section 5 requires that any health practitioner who delivers, or assists in delivery, of a newborn in the Philippines must prior to delivery inform the parents or legal guardian of newborn availability, nature, and benefits of newborn screening.
Section 5 places responsibility for appropriate notification and education of this informing obligation on the Department of Health (DOH).
Section 6 requires newborn screening to be performed after twenty-four (24) hours of life but not later than three (3) days from complete delivery.
Section 6 provides an exception: a newborn needing intensive care to ensure survival is exempted from the 3-day requirement but must be tested by seven (7) days of age.
Section 6 makes newborn screening a joint responsibility of the parent(s) and the practitioner or other person delivering the newborn to ensure screening is performed.
Section 6 directs the DOH to make available an appropriate informational brochure for parents to assist them in fulfilling this responsibility and to distribute it to all health institutions and make it available to any practitioner for appropriate distribution.

Refusal, education, and health personnel training

Section 7 allows a parent or legal guardian to refuse testing on grounds of religious beliefs.
Section 7 requires that refusal be accompanied by acknowledgment in writing that refusal places the newborn at risk for undiagnosed heritable conditions.
Section 7 requires that a copy of the refusal documentation be made part of the newborn’s medical record.
Section 7 requires that refusal be indicated in the national newborn screening database.
Section 8 mandates that the DOH, with assistance of the NIH and other government agencies, professional societies, and non-government organizations, conduct continuing information, education, re-education and training programs for health personnel on the rationale, benefits, and procedures of newborn screening.
Section 8 mandates dissemination of newborn screening information materials at least annually to all health personnel involved in maternal and pediatric care.

Licensing, accreditation, and system lead roles

Section 9 requires the DOH and the Philippine Health Insurance Corporation (PHIC) to require health institutions to provide newborn screening services as a condition for licensure or accreditation.
Section 10 designates the DOH as the lead agency implementing the Act.
Section 10 requires the DOH to establish the Advisory Committee on Newborn Screening.
Section 10 requires the DOH to develop implementing rules and regulations for immediate implementation of a nationwide program within one hundred eighty (180) days from enactment of the Act.
Section 10 requires the DOH to coordinate with the Department of the Interior and Local Government (DILG) for program implementation.
Section 10 requires the DOH to coordinate with the NIH Newborn Screening Reference Center for accreditation of Newborn Screening Centers and preparation of defined testing protocols and quality assurance programs.

Advisory Committee governance and functions

Section 11 creates the Advisory Committee on Newborn-Screening as an integral part of the Office of the Secretary of the DOH to ensure sustained inter-agency collaboration.
Section 11 requires annual review and recommendations by the Committee, including: conditions for inclusion in the newborn screening panel of disorders; the newborn screening fee charged by Newborn Screening Centers; and the report on quality assurance of centers with recommendations for corrective measures.
Section 11 provides that the Committee has eight (8) members, with the Secretary of Health as Chairperson.
Section 11 appoints the following additional members: the Executive Director of the NIH as Vice Chairperson; an Undersecretary of the DILG; the Executive Director of the Council for the Welfare of Children; the Director of the Newborn Screening Reference Center; and three (3) representatives appointed by the Secretary of Health.
Section 11 requires the three appointed representatives to be a pediatrician, obstetrician, endocrinologist, family physician, nurse or midwife, from either the public or private sector.
Section 11 provides that the three representatives are appointed for a term of three (3) years, subject to reappointment for additional three (3) year periods for each extension.
Section 11 requires the Committee to meet at least twice a year, with the NIH serving as Secretariat.

Newborn Screening Centers and reference center operations

Section 12 requires the DOH to ensure Newborn Screening Centers are strategically located for accessibility to relevant public.
Section 12 requires centers to provide services that comply with standards approved by the Advisory Committee upon recommendation of the NIH.
Section 12 prohibits operation of any Newborn Screening Center unless it has been duly accredited by the DOH based on standards set forth by the Committee.
Section 12 requires, at minimum, each Newborn Screening Center to: have a certified laboratory performing all tests included in the newborn screening program; have recall/follow-up programs for infants found positive of any and all heritable conditions; be supervised and staffed by trained personnel duly qualified by the NIH; and submit to periodic announced or unannounced inspections by the Reference Center to evaluate and ensure quality.
Section 13 requires the NIH to establish a Newborn Screening Reference Center responsible for the national testing database and case registries, training, technical assistance, and continuing education for laboratory staff in all Newborn Screening Centers.
Section 14 requires the NIH Reference Center to draft and ensure good laboratory practice standards, including establishing an external laboratory proficiency testing and certification program.
Section 14 requires the Reference Center to act as the principal repository of technical information relating to newborn screening standards and practices and to provide technical assistance to centers needing assistance.

Database, annual reporting, and long-term evaluation plan

Section 15 requires all Newborn Screening Centers to coordinate with the NIH Reference Center for consolidation of patient databases.
Section 15 requires the NIH Reference Center to maintain: a national database of patients tested and a registry for each condition.
Section 15 requires the NIH Reference Center to submit reports annually to the Committee and the DOH on status of and relevant health information derived from the database.
Section 15 requires the NIH Reference Center to develop, with the Advisory Committee on Newborn Screening, a plan for long-term outcome evaluation using the case registries within one (1) year of passage of the Act.
Section 15 assigns implementation of the long-term outcome evaluation plan to the Advisory Committee on Newborn Screening.

Newborn screening fees and allocation

Section 16 requires PHIC to include cost of newborn screening in its benefits package.
Section 16 directs that the newborn screening fee covers, among others, testing costs, education, sample transport, follow-up, and reasonable overhead expenses.
Section 16 requires dividing and setting aside the newborn screening fee to sustain the national system, including allocations of at least four percent (4%) each to:
- the DOH’s Centers for Health Development or its future equivalent, spent solely for follow-up services, education, and other activities directly related to newborn screening services;
- the Newborn Screening Centers for human resource development and equipment maintenance and upgrading;
- the NIH Newborn Screening Reference Center for overall supervision, training and continuing education, maintenance of the national database, quality assurance program, and monitoring of the national program.
Section 16 requires that the remaining balance be for the operational and other expenses of the Newborn Screening Center.

Final provisions: repeal, separability, effectivity

Section 17 repeals or modifies accordingly all general and special laws, decrees, executive orders, proclamations, and administrative regulations, or parts thereof, that are inconsistent with the Act.
Section 18 provides separability: if any part is declared unconstitutional or invalid, the unaffected provisions continue in full force and effect.
Section 19 provides effectivity: the Act takes effect fifteen (15) days after its publication in at least two (2) newspapers of general circulation.