Declaration of Policy
- The State aims to protect and promote the right to health, especially for children.
- It mandates the establishment of a comprehensive, integrative, and sustainable national newborn screening system.
- Emphasis on collaboration among government agencies, private sector, families, communities, and professional organizations.
- Objective to offer newborn screening to every baby to detect heritable conditions that may cause mental retardation or death.
Objectives of the National Newborn Screening System
- Ensure universal access to newborn screening for heritable conditions that can cause severe health issues.
- Integrate the newborn screening system within the public health delivery system.
- Increase health practitioners' awareness of the benefits and responsibilities of newborn screening.
- Encourage parents to uphold their responsibility to promote their child’s health through screening.
Definitions
- Comprehensive Newborn Screening System: Includes education, biochemical screening, confirmatory testing, clinical evaluation, treatment, and quality assessment.
- Follow-up: Monitoring a newborn with a heritable condition to ensure treatment compliance.
- Health Institutions: Hospitals, health centers, lying-in centers with obstetrical and pediatric services.
- Healthcare Practitioner: 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: Blood test for heritable conditions.
- Newborn Screening Center: Laboratory facility meeting NIH standards for newborn screening.
- Newborn Screening Reference Center: NIH central facility managing protocols, training, database, and program oversight.
- Parent Education: Informing parents/legal guardians about newborn screening.
- Recall: Locating newborns with positive screening for confirmatory tests and treatment.
- Treatment: Medical, surgical, or dietary intervention for heritable conditions.
Obligation to Inform
- Health practitioners must inform parents/legal guardians before delivery about newborn screening benefits.
- DOH responsible for notification and education on this obligation.
Performance of Newborn Screening
- Screening to be conducted after 24 hours but not later than 3 days from delivery.
- Newborns in intensive care may be tested by 7 days.
- Joint responsibility of parents and health practitioners to ensure screening.
- DOH to provide informational brochures to assist parents.
Refusal to be Tested
- Parents/legal guardians may refuse on religious grounds.
- Written acknowledgment of risk must be provided.
- Refusal documented in medical records and national screening database.
Continuing Education and Training
- DOH, with NIH and other entities, to conduct ongoing education and training for health personnel.
- Annual dissemination of newborn screening materials to maternal and pediatric care personnel.
Licensing and Accreditation
- DOH and PHIC require health institutions to provide newborn screening as a condition for license/accreditation.
Lead Agency and Responsibilities
- DOH is the lead agency for implementation.
- Establishment of Advisory Committee on Newborn Screening.
- Development of implementing rules within 180 days.
- Coordination with DILG and NIH Reference Center for program implementation.
Advisory Committee on Newborn Screening
- Created within DOH Office of the Secretary.
- Reviews conditions for the screening panel and recommends fees.
- Reviews quality assurance reports and recommends corrective actions.
- Composed of 8 members including Secretary of Health as Chairperson.
- Meets at least twice a year.
Establishment and Accreditation of Newborn Screening Centers
- DOH ensures strategic location and accreditation based on NIH standards.
- Centers must have certified labs, recall/follow-up program, trained staff, and submit to inspections.
Newborn Screening Reference Center
- NIH establishes the Reference Center for national database, training, technical assistance, and continuing education.
Quality Assurance
- Reference Center drafts standards, runs laboratory proficiency program, and provides technical assistance to centers.
Database Management
- Coordinated by NIH Reference Center.
- Maintains national patient database and condition registries.
- Annual reports to Advisory Committee and DOH.
- Develops plan for long-term outcome evaluation within one year.
Newborn Screening Fees
- PHIC includes screening costs in benefits package.
- Fee covers testing, education, sample transport, follow-up, overhead.
- Allocations: 4% to DOH Centers for Health Development; 4% to Screening Centers for HR and maintenance; 4% to NIH Reference Center for supervision and training; remainder for operational expenses.
Repealing Clause
- All inconsistent laws, decrees, and regulations are repealed or modified.
Separability Clause
- If any part is declared invalid, remaining provisions continue in force.
Effectivity
- Act takes effect 15 days after publication in two newspapers of general circulation.