9288 Newborn Screening Act of 2004

• Newborn Screening (NBS)


  A simple procedure to find out if your baby has a congenital disorder that may lead to mental retardation or even death if left untreated
• How Newborn Screening is done

  A few drops of blood are taken from the baby's heel, blotted on a special absorbent filter card and then sent to Newborn Screening Center (NSC)
• Who will collect the sample for ENBS

  The blood sample for ENBS may be collected by any of the following: physician, nurse, medical technologist or trained midwife
• Newborn Care Package (NCP)

  A PhilHealth benefit package for essential health services of the newborn during the first few days of life. It covers essential newborn care, expanded newborn screening, and hearing screening tests
• RA 9288 is the NEWBORN SCREENING ACT OF 2004
• Declaration of Policy

  It is the policy of the State to protect and promote the right to health of the people, including the rights of children to survival and full and healthy development as normal individuals
• Follow-up


  The monitoring of a newborn with a heritable condition for the purpose of ensuring that the newborn patient complies fully with the medicine of 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 of the newborn
• NIH

  National Institute of Health
• Newborn


  A 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 for determining if the newborn has a heritable condition
• Newborn Screening Center


  Facility equipped with a newborn screening laboratory that complies with the standards established by the NIH and provides all required laboratory tests and recall/follow-up programs for newborns with heritable conditions
• Recall


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


  The provision of prompt, appropriate and adequate medicine, medical, and surgical management or dietary prescription to a newborn for purposes of treating or mitigating the adverse health consequences of the heritable condition
• Performance of Newborn Screening

  Newborn screening shall be performed after twenty-four (24) hours of life but not later than three (3) days from complete delivery of the newborn. A newborn that must be placed in intensive care in order to ensure survival may be exempted from the 3-day requirement but must be tested by seven (7) days of age
• Implementation

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

  • Establish the Advisory Committee on Newborn Screening
  • Develop the implementing rules and regulations for the immediate implementation of a nationwide newborn screening program within one hundred eighty (180) days from the enactment of this Act
  • Coordinate with the Department of the Interior and Local Government (DILG) for implementation of the newborn screening program
  • Coordinate with the NIH Newborn Screening Reference Center for the accreditation of Newborn Screening Centers and preparation of defined testing protocols and 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)
  • The Executive Director of the NIH (Vice Chairperson)
  • An Undersecretary of the DILG
  • The Executive Director of the Council for the Welfare of Children
  • The Director of the Newborn Screening Reference Center
  • Three (3) representatives appointed by the Secretary of Health
• Newborn Screening Centers


  • Strategically located to be accessible to the relevant public
  • Provide services that comply with the standards approved by the Committee upon the recommendation of the NIH
• 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 in order to evaluate and ensure quality Newborn Screening Center performance
• Newborn Screening Reference Center

  • Responsible for the national testing database and case registries, training, technical assistance and continuing education for laboratory staff in all Newborn Screening Centers
• Newborn Screening Reference Center

  1. Draft and ensure good laboratory practice standards for newborn screening centers, including establishing an external laboratory proficiency testing and certification program

  2. Act as the principal repository of technical information relating to newborn screening standards and practices

  3. Provide technical assistance to newborn screening centers needing such assistance
• Newborn Screening Centers

  1. Coordinate with the NIH Newborn Screening Reference Center for consolidation of patient databases

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

  3. Submit reports annually to the Committee and to the DOH on the status of and relevant health information derived from the database
• Newborn screening fee


  Includes testing costs, education, sample transport, follow-up and reasonable overhead expenses
• The PHIC shall include cost of newborn screening in its benefits package
• DOH Administrative Order 2005-0005 standardized the NBS fee at P550.00 and set the maximum allowable service fee at P50.00
• DOH Administrative Order 2008-0026-A addresses the issue of health facilities refusing to provide newborn screening (NBS) services or charging more than the maximum allowed NBS fee
• Administrative fines for non-compliance

  • First offense: Warning
  • Second offense: Administrative fine of fifty thousand pesos (P50,000.00)
  • Third offense: Administrative fine of one hundred thousand pesos (P100,000.00)
• Disorders screened in newborn screening

  • Congenital hypothyroidism (Cretinism)
  • Congenital adrenal hyperplasia
  • Galactosemia
  • Phenylketonuria
  • G6PD deficiency
• DOH Memorandum Order 2012-0154 included Maple Syrup Urine Disease (MSUD) in the newborn screening panel of disorders
• The expanded newborn screening program will increase the screening panel of disorders from six (6) to twenty-eight (28)
• Disorders included in the expanded newborn screening program

  • Glucose-6 Phosphate Dehydrogenase Deficiency
  • Congenital Hypothyroidism
  • Congenital Adrenal Hyperplasia
  • Galactosemia
  • Phenylketonuria
  • Maple Syrup Urine Disease
  • Cystic Fibrosis
  • Biotinidase Deficiency
  • Organic Acid Disorders
  • Fatty Acid Oxidation Disorders
  • Amino Acid Disorders
  • Urea Cycle Disorders
  • Hemoglobin Disorders
• The expanded newborn screening program is given as an option for the price of One Thousand Five Hundred Pesos
• COMPREHENSIVE NEWBORN SCREENING SYSTEM

  • education of relevant stakeholders;
  • collection and biochemical screening of blood samples taken from newborns;
  • tracking and confirmatory testing to ensure the accuracy of screening results;
  • clinical evaluation and biochemical/medical confirmation of test results;
  • rugs and medical/surgical management and dietary supplementation to address the heritable conditions;
  • evaluation activities to assess long term outcome, patient compliance and quality assurance.
• REFUSAL TO BE TESTED A copy of this refusal documentation shall be made part of the newborn's medical record and refusal shall be indicated in the national newborn screening database.
• Licensing & accreditation

  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.