QuestionsQuestions (Republic Act No. 9288)
RA 9288 declares it is the policy of the State to protect and promote the people’s right to health, including children’s rights to survival and full, healthy development. It institutionalizes a comprehensive, integrative, and sustainable national newborn screening system to ensure every baby in the Philippines is offered newborn screening to spare them from heritable conditions that can cause mental retardation and death if undetected and untreated.
The objectives are: (1) ensure every newborn has access to screening for certain heritable conditions that can cause mental retardation, serious complications, or death; (2) establish and integrate a sustainable system within the public health delivery system; (3) ensure health practitioners know the advantages and their responsibilities to offer screening; and (4) ensure parents recognize their responsibility in preventing preventable disability and death through newborn screening.
A heritable condition is 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.
A newborn is a child from the time of complete delivery to 30 days old.
It is the process of collecting a few drops of blood from the newborn onto an appropriate collection card and performing biochemical testing to determine if the newborn has a heritable condition.
Newborn screening shall be performed after 24 hours of life but not later than 3 days from complete delivery; if the newborn must be placed in intensive care, it may be exempted from the 3-day requirement but must be tested by 7 days of age.
The joint responsibility lies with the parent(s) and the practitioner or other person delivering the newborn to ensure newborn screening is performed.
A parent or legal guardian may refuse testing on religious beliefs but must acknowledge in writing understanding that refusal places the newborn at risk for undiagnosed heritable conditions. A copy of the refusal documentation must be made part of the newborn’s medical record, and refusal must be indicated in the national newborn screening database.
Any health practitioner who delivers or assists in the delivery must, prior to delivery, inform parents or legal guardians of the availability, nature, and benefits of newborn screening. Appropriate notification and education regarding this obligation is the responsibility of the DOH.
The DOH, with assistance of NIH and other entities, must conduct continuing information, education, re-education, and training programs for health personnel on the rationale, benefits, and procedures of newborn screening, and disseminate information materials on newborn screening at least annually to all involved health personnel.
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.
The DOH is the lead agency. It must establish the Advisory Committee on Newborn Screening; develop IRR within 180 days from enactment for immediate nationwide implementation; coordinate with DILG for implementation; and coordinate with the NIH Newborn Screening Reference Center for accreditation of Newborn Screening Centers and preparation of testing protocols and quality assurance.
The Committee has eight members, including the Secretary of Health as Chairperson. Other members include the Executive Director of NIH as Vice Chairperson; an Undersecretary of DILG; the Executive Director of the Council for the Welfare of Children; the Director of the Newborn Screening Reference Center; and three representatives appointed by the Secretary of Health who may be pediatrician, obstetrician, endocrinologist, family physician, nurse, or midwife from public or private sector. The NIH serves as the Secretariat.
At a minimum, a center must: (i) have a certified laboratory performing all tests included in the program; (ii) have recall/follow-up programs for infants found positive; (iii) be supervised and staffed by trained personnel qualified by the NIH; and (iv) submit to periodic announced or unannounced inspections by the Reference Center to evaluate quality performance.
It establishes and operates the Reference Center responsible for the national testing database and case registries, training and technical assistance, and continuing education for laboratory staff. It also supports oversight functions such as maintaining protocols/assurance, external proficiency testing, and acting as principal repository of technical information.
All Newborn Screening Centers must coordinate with the Reference Center to consolidate patient databases. The Reference Center maintains a national database and condition registries and submits annual reports to the Committee and DOH. A plan for long-term outcome evaluation using the registries must be developed within one year by the Reference Center in consultation with the Advisory Committee, and implementation is then the responsibility of the Advisory Committee.
PHIC must include newborn screening cost in its benefits package. The newborn screening fee covers testing costs, education, sample transport, follow-up, and reasonable overhead expenses. At least 4% each is allocated to: (1) DOH’s Centers for Health Development (or future equivalent) for follow-up services/education directly related to provision; (2) Newborn Screening Centers for human resource development and equipment maintenance/upgrading; (3) NIH Reference Center for supervision, training/continuing education, database maintenance, quality assurance, and monitoring; and the remaining balance for the operational and other expenses of the Newborn Screening Center.
The Act takes effect fifteen (15) days after its publication in at least two newspapers of general circulation.