Republic Act No. 9288: Newborn Screening Act

• Republic Act No. 9288 is the Newborn Screening Act.
• It was approved on April 7, 2004.
• Signed by President Gloria Macapagal-Arroyo.
• It took effect 15 days after publication in two newspapers.
• The Adopted IRR Date: October 22, 2004

General Provisions

• Referred to as the Newborn Screening Act of 2004.
• State policy promotes child health through a national newborn screening system.
• Objectives include universal newborn screening, integrating it into the public health system and parental awareness and responsibility,.

Definition of Terms

• Newborn Screening (NBS) refers to blood tests for early detection of heritable disorders.
• Heritable conditions can cause mental or physical impairment if untreated.
• Newborn Screening Centers (NSC) are DOH-accredited lab facilities.
• Reference Centers (NSRC) are located at NIH and manage databases, training and protocols.

Newborn Screening Guidelines

• Health workers must inform parents before delivery regarding newborn screening.
• Screening should occur after 24 hours but no later than 3 days unless in ICU up to testing by the 7th day.
• Refusal is allowed for religious reasons, with a signed waiver required for record.
• The DOH ensures continued education of health personnel on newborn screening.
• NSC services require both DOH and PHIC accreditation.

Implementation

• The lead agency is the DOH.
• The Advisory Committee on NBS (ACNBS) reviews disorders to include in the screening panel and oversees fees and quality assurance.
• NSC requirements include laboratory testing, and recall/follow-up programs with trained personnel.
• The NSRC at NIH maintains databases, protocols, and QA programs.
• NBS fees are covered by PhilHealth and allocated across DOH, NSCs, and NSRC.

Implementing Rules and Regulations (IRR)

• Reinforces RA 9288 objectives and definitions.
• Defines the roles of DOH, DILG, LGUs, PHIC, and NIH.

National Comprehensive Newborn Screening System (NCNBSS)

• Includes education of stakeholders, sample collection and transport, biochemical screening, confirmatory testing, and a referral to treatment network.
• Sample collection must be done within 24–72 hours post-birth or by the 7th day if in the ICU.
• Positive screens must be followed up immediately and confirmed cases are referred to specialists.
• DOH leads implementation, establish policies and develops referral networks.
• DILG & LGUs are tasked with enforcing policies at local levels and monitoring implementation.
• Academe/Health Professional Societies are responsible for training professionals and including NBS in the curriculum.
• The Council for the Welfare of Children promotes integration with ECCD programs.

Advisory Committee on NBS

• Consists of 8 members from DOH, NIH, DILG, CWC, NSRC, and 3 appointed experts.
• It meets twice annually and updates the disorder panel, monitors fees, and evaluates NSC performance.

NBS Fees and Funding

• PhilHealth covers costs, including testing, education, recall, and operations.
• Fee allocation includes:
  • 4% to DOH-CHD for follow-up and education
  • 4% to NSCs for HR and equipment
  • 4% to NSRC for training, QA and database
  • the remaining goes to NSC operations
• Kits are available at health units with PHIC reimbursement schemes for members.

Newborn Screening Centers

• Must be DOH-accredited.
• Should serve at least 50,000 samples annually.
• Should provide full testing, recall, and case reporting.
• Must have appropriate equipment, trained personnel, and adequate facilities.

Newborn Screening Reference Center (NSRC)

• Based at NIH.
• Resposibilities include defining protocols, maintaining case registries and quality assurance programs, and providing training and technical support.

Final Provisions

• Repealing Clause: Laws inconsistent with RA 9288 are repealed.
• Includes a Separability Clause.
• Provides effectivity 15 days after publication.

Accreditation Requirements for NSCs

• Requires minimum testing of 150 samples/day.
• Conditions Covered: CAH, CH, PKU, GAL, G6PD
• Facility requirements of ≥100 sqm with proper storage, equipment, and a cold chain.

Newborn Filter Card and Sample Collection Procedures

• Critical to collect and transport dried blood spots for testing, ensuring accurate data entry, timely follow-up.

Newborn Filter Card: Practitioner's Information

• Practitioner's Type: Doctor, Nuese, Midwife
• Practitioner's Information:
  • Mobile and day contact
• Baby status upon sampling: Note antibiotics and if premature

Newborn Filter Card: Parent/Guardian Information

• Both names and address are important, along with contact number
• Expanded Screening: If newborn has been part of expanded screening