QuestionsQuestions (Republic Act No. 9288)
RA 9288 is the “Newborn Screening Act of 2004.” Its purpose is to institutionalize a national newborn screening system to ensure every baby in the Philippines is offered screening for certain heritable conditions to prevent mental retardation, serious health complications, or death if undetected and untreated.
The objectives include: (1) ensuring newborn access to screening for specified heritable conditions; (2) establishing and integrating a sustainable system within public health delivery; (3) ensuring health practitioners are aware of benefits and their responsibilities; and (4) ensuring parents recognize their responsibility to protect their child through newborn screening.
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.
Any health practitioner who delivers or assists in the delivery must, prior to delivery, inform the parents or legal guardian of the availability, nature, and benefits of newborn screening. DOH is responsible for appropriate notification and education of this obligation.
Screening must be done after 24 hours of life but not later than three (3) days from complete delivery. A newborn requiring intensive care may be exempted from the three-day requirement but must be tested by seven (7) days of age.
The joint responsibility belongs to the parent(s) and the practitioner or other person delivering the newborn.
Yes. A parent or legal guardian may refuse testing on the grounds of religious beliefs.
They must acknowledge in writing their understanding that refusal places the newborn at risk for undiagnosed heritable conditions. A copy of the refusal documentation must be part of the newborn’s medical record and refusal must be indicated in the national newborn screening database.
DOH, with assistance from NIH and other agencies, professional societies, and NGOs, must conduct continuing information/education/re-education/training programs for health personnel and disseminate newborn screening information materials at least annually to all health personnel involved in maternal and pediatric care.
DOH and 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: (1) establish the Advisory Committee on Newborn Screening; (2) develop the IRR for immediate nationwide program implementation within 180 days; (3) coordinate with DILG for implementation; and (4) coordinate with NIH Newborn Screening Reference Center for accreditation standards, testing protocols, and quality assurance.
It has eight (8) members: the Secretary of Health (Chair), the Executive Director of NIH (Vice Chair), 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 (3) representatives appointed by the Secretary of Health (pediatrician, obstetrician, endocrinologist, family physician, nurse or midwife). Functions: annual review and recommendations on the newborn screening panel; recommend the newborn screening fee; review NIH reference center quality assurance reports and recommend corrective measures.
At minimum, it must: (i) have a certified laboratory performing all tests in the newborn screening program; (ii) have recall/follow-up programs for infants testing positive; (iii) be supervised and staffed by trained personnel qualified by NIH; and (iv) submit to periodic announced or unannounced inspections by the Reference Center.
NIH must establish it. It is responsible for the national testing database and case registries, training/technical assistance/continuing education for laboratory staff in centers, and other oversight roles described in the Act (including standards and quality assurance coordination).
The NIH Reference Center must draft and ensure good laboratory practice standards, establish an external laboratory proficiency testing and certification program, act as the principal repository of technical information, and provide technical assistance to centers needing support.
PHIC includes newborn screening in its benefits package. The newborn screening fee covers testing, education, sample transport, follow-up, and reasonable overhead. For sustainability, the fee is divided: at least 4% for DOH Centers for Health Development (follow-up services, education, and related activities); at least 4% for Newborn Screening Centers (human resource development and equipment maintenance/upgrading); at least 4% for NIH Reference Center (supervision, training/continuing education, database maintenance, quality assurance, and monitoring); and the balance for the operational and other expenses of the Newborn Screening Center.