9288

• REPUBLIC ACT NO. 9288 (R.A. 9288)
• Date of Approval

  April 7, 2004
• Gloria Macapagal Arroyo
• AN ACT PROMULGATING A COMPREHENSIVE POLICY AND A NATIONAL SYSTEM FOR ENSURING NEWBORN SCREENING
• Comprehensive Newborn Screening System


  Newborn screening system that includes education of relevant stakeholders; collection and biochemical screening of blood samples; tracking and confirmatory testing; clinical evaluation and confirmation; drugs, medical/surgical management and dietary supplementation; and evaluation activities
• Follow-up


  Monitoring of a newborn with a heritable condition to ensure compliance with medicine or dietary prescriptions
• Health Institutions


  Hospitals, health infirmaries, health centers, lying-in centers or puericulture centers with obstetrical and pediatric services, whether public or private
• Healthcare Practitioner


  Physicians, nurses, midwives, nursing aides and traditional birth attendants
• Heritable Condition


  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
• NIH


  National Institute of Health
• Newborn


  Child from the time of complete delivery to 30 days old
• Newborn Screening


  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 Center


  A facility equipped with a newborn screening laboratory that complies with NIH standards and provides all required laboratory tests and recall/follow-up programs
• Newborn Screening Reference Center

  The central facility at the NIH that defines testing and follow-up protocols, maintains an external laboratory proficiency testing program, oversees the national testing database and case registries, assists in training activities, oversees educational materials, and acts as the Secretariat of the Advisory Committee
• Parent Education


  Various means of providing parents or legal guardians information about newborn screening
• Recall

  A procedure for locating a newborn with a possible heritable condition for purposes of providing the newborn with appropriate laboratory testing to confirm the diagnosis and provide treatment
• Treatment


  The provision of prompt, appropriate and adequate medicine, medical, and surgical management or dietary prescription to a newborn to treat or mitigate the adverse health consequences of the heritable condition
• Any health practitioner who delivers, or assists in the delivery, of a newborn in the Philippines shall, prior to delivery, inform the parents or legal guardian of the newborn of the availability, nature and benefits of newborn screening
• Newborn Screening


  1. Performed after 24 hours of life but not later than 3 days from complete delivery

  2. Newborn that must be placed in intensive care may be exempted from the 3-day requirement but must be tested by 7 days of age

  3. Joint responsibility of parent(s) and practitioner to ensure newborn screening is performed
• A parent or legal guardian may refuse testing on the grounds of religious beliefs, but shall acknowledge in writing their understanding that refusal for testing places their newborn at risk for undiagnosed heritable conditions
• Continuing Education, Re-education and Training Health Personnel


  1. DOH, with assistance of NIH and other agencies, shall conduct continuing information, education, re-education and training programs for health personnel on newborn screening

  2. DOH shall disseminate information materials on newborn screening at least annually to all health personnel involved in maternal and pediatric care
• 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
• Lead Agency


  The DOH shall be the lead agency in implementing this Act
• Implementation by DOH


  1. Establish the Advisory Committee on Newborn Screening

  2. Develop the implementing rules and regulations within 180 days

  3. Coordinate with DILG for implementation

  4. Coordinate with NIH Newborn Screening Reference Center for accreditation of Newborn Screening Centers and preparation of testing protocols and quality assurance programs
• The Advisory Committee on Newborn Screening is hereby created and made an integral part of the Office of the Secretary of the DOH
• The Committee shall review annually and recommend conditions to be included in the newborn screening panel of disorders; review and recommend the newborn screening fee; review the report of the Newborn Screening Reference Center on the quality assurance of the National Screening Centers and recommend corrective measures
• Coordinate with the NIH Newborn Screening Reference Center for

  1. Accreditation of Newborn Screening Centers

  2. Preparation of defined testing protocols

  3. Preparation of quality assurance programs
• Advisory Committee on Newborn Screening

  Integral part of the Office of the Secretary of the DOH
• Advisory Committee on Newborn Screening

  1. Review annually and recommend conditions to be included in the newborn screening panel of disorders

  2. Review and recommend the newborn screening fee to be charged by Newborn Screening Centers

  3. Review the report of the Newborn Screening Reference Center on the quality assurance of the National Screening Centers and recommend corrective measures as deemed necessary
• Members of the Advisory Committee on Newborn Screening

  • Secretary of Health (Chairman)
  • Executive Director of the NIH (Vice Chairperson)
  • Undersecretary of the DILG
  • Executive Director of the Council for the Welfare of Children
  • Director of the Newborn Screening Reference Center
  • 3 representatives appointed by the Secretary of Health (pediatrician, obstetrician, endocrinologist, family physician, nurse or midwife, from either the public or private sector)
• Establishment and Accreditation of Newborn Screening Centers

  1. DOH ensures Newborn Screening Centers are strategically located and provide services that comply with the standards approved by the Committee

  2. No Newborn Screening Center shall be allowed to operate unless it has been duly accredited by the DOH based on the standards set forth by the Committee
• Minimum requirements for Newborn Screening Centers

  • Have a certified laboratory performing all tests included in the newborn screening program
  • Have a recall/follow up programs for infants found positive for any and all of the heritable conditions
  • Be supervised and staffed by trained personnel who have been duly qualified by the NIH
  • Submit to periodic announced or unannounced inspections by the Reference Center to evaluate and ensure quality performance
• Newborn Screening Reference Center


  Established by the NIH, responsible for the national testing database and case registries, training, technical assistance and continuing education for laboratory staff in all Newborn Screening Centers
• SECTION 14 Quality Assurance

  1. NIH Newborn Screening Reference Center drafts and ensures good laboratory practice standards for newborn screening centers, including establishing an external laboratory proficiency testing and certification program

  2. Acts as the principal repository of technical information relating to newborn screening standards and practices, and provides technical assistance to newborn screening centers needing such assistance
• Database


  1. All Newborn Screening Centers coordinate with the NIH Newborn Screening Reference Center for consolidation of patient databases

  2. NIH Newborn Screening Reference Center maintains a national database of patients tested and a registry for each condition

  3. Submits reports annually to the Committee and to the DOH on the status of and relevant health information derived from the database

  4. Develops a plan for long-term outcome evaluation of newborn screening utilizing the cases registries within 1 year of passage of this Act, in consultation with the Advisory Committee on Newborn Screening
• Newborn Screening Fees


  • PHIC includes cost of newborn screening in its benefits package
  • Newborn screening fee covers testing costs, education, sample transport, follow-up and reasonable overhead expenses
  • At least 4% to the DOH's Centers for Health Development for follow-up services, education and other activities
  • At least 4% to the Newborn Screening Centers for human resource development and equipment maintenance and upgrading
  • At least 4% to the NIH Newborn Screening Reference Center for overall supervision, training and continuing education, maintenance of national database, quality assurance program and monitoring of the national program
  • The balance for the operational and other expenses of the Newborn Screening Center
• Refusal of newborn screening is allowed provided that parents present a refusal letter
• Authorized personnel to collect blood for newborn screening

  • Registered Medical Technologists
  • Registered Nurses
  • Licensed Physician
  • Registered Midwife
• Hemoglobinopathies screened


  • Sickle Cell Disease
  • Hemoglobin C Disease
  • Hemoglobin SC
  • Hemoglobin D
  • Hemoglobin E
  • Hemoglobin Constant Spring
  • Thalassemia
• Endocrinopathies screened


  • Congenital Hypothyroidism
  • Classic/Congenital Adrenal Hyperplasia