Law Summary
Declaration of Policy
- The State's policy is to protect and promote the right to health, especially children's survival and healthy development.
- Institutionalize a national newborn screening system that is comprehensive, integrative, and sustainable.
- Facilitate collaboration among government agencies, private sector, families, communities, professional organizations, and NGOs.
- Ensure every baby in the Philippines is offered newborn screening to detect heritable conditions that could lead to mental retardation or death if untreated.
Objectives of the National Newborn Screening System
- Ensure all newborns have access to screening for certain heritable conditions causing mental retardation or death.
- Establish and integrate a sustainable newborn screening system within the public health system.
- Ensure health practitioners understand the benefits and responsibilities related to newborn screening.
- Promote parental responsibility in protecting children from preventable disabilities and death through screening.
Definitions
- Comprehensive Newborn Screening System: inclusive of education, biochemical testing, confirmatory testing, clinical evaluation, treatment, and quality assurance.
- Follow-up: monitoring to ensure compliance with medicine or dietary prescriptions.
- Health institutions: hospitals, health centers, lying-in centers with obstetrical and pediatric services.
- Healthcare practitioners: physicians, nurses, midwives, nursing aides, traditional birth attendants.
- Heritable condition: genetic conditions causing mental retardation, deformity, or death if untreated.
- NIH: National Institute of Health.
- Newborn: child from birth to 30 days old.
- Newborn Screening: collection of blood and biochemical testing for heritable conditions.
- Newborn Screening Center: laboratory facility meeting NIH standards and providing full screening and follow-up.
- Newborn Screening Reference Center: central NIH facility managing protocols, quality assurance, database, training, and advisory roles.
- Parent education: providing information to parents/legal guardians about screening.
- Recall: locating newborns with possible heritable conditions for confirmatory testing and treatment.
- Treatment: appropriate medical/surgical management or dietary therapy.
Obligation to Inform
- Health practitioners delivering newborns must inform parents/legal guardians before delivery about newborn screening availability, nature, and benefits.
- DOH is responsible for notification and education on this obligation.
Performance of Newborn Screening
- Screening must occur after 24 hours but before 3 days of birth.
- Newborns in intensive care may be tested by 7 days old.
- Responsibility is shared between parents and practitioners.
- DOH must provide informational brochures for distribution.
Refusal to be Tested
- Parents/legal guardians can refuse testing for religious beliefs but must acknowledge in writing the risks.
- Refusal documentation becomes part of medical records and national database.
Continuing Education and Training of Health Personnel
- DOH, with NIH and other partners, will conduct ongoing education and training on the rationale, benefits, and procedures of newborn screening.
- Annual dissemination of information materials to maternal and pediatric care personnel is mandated.
Licensing and Accreditation
- Provision of newborn screening services is a condition for licensure or accreditation by DOH and PHIC.
Lead Agency and Implementation
- DOH is the lead agency responsible for implementation.
- Establish an Advisory Committee on Newborn Screening.
- Develop implementing rules within 180 days of enactment.
- Coordinate with DILG and NIH for program implementation and accreditation.
Advisory Committee on Newborn Screening
- Created under the DOH Office of the Secretary to ensure inter-agency collaboration.
- Duties include annual review of screening panel, fees, quality reports, and corrective recommendations.
- Composed of 8 members including Secretary of Health (Chair), NIH Director (Vice Chair), DILG Undersecretary, Welfare of Children Executive Director, Newborn Screening Reference Center Director, and 3 appointed health professionals.
- Committee meets at least twice yearly; NIH acts as Secretariat.
Establishment and Accreditation of Newborn Screening Centers
- DOH to ensure centers are accessible and meet Committee and NIH standards.
- Accreditation required before operation.
- Minimum requirements: certified laboratory, recall/follow-up programs, trained personnel qualified by NIH, periodic inspections.
Establishment of Newborn Screening Reference Center
- NIH to establish the Center responsible for national database, training, technical assistance, and education for lab staff nationwide.
Quality Assurance
- NIH Reference Center drafts and enforces good laboratory practices.
- Establishes proficiency testing, certification, and serves as main technical information repository.
Database
- All centers coordinate with NIH Reference Center for consolidation.
- NIH maintains national database and registries; submits annual reports.
- NIH and Advisory Committee to develop and implement long-term outcome evaluation plan within 1 year.
Newborn Screening Fees
- PHIC includes screening cost in benefits package.
- Fees cover testing, education, sample transport, follow-up and overhead.
- Fee allocations: minimum 4% to DOH Centers for Health Development for follow-up/education; minimum 4% to Centers for human resource development and equipment; minimum 4% to NIH Reference Center for supervision, training, database, quality assurance; remainder for operational expenses.
Repealing Clause
- Laws and regulations inconsistent with this Act are repealed or modified.
Separability Clause
- If any part declared unconstitutional or invalid, other provisions remain effective.
Effectivity
- The Act takes effect 15 days after publication in two general circulation newspapers.