Newborn Screening Act

• Newborn screening is simple, non invasive procedure to find out if a baby has a congenital metabolic disorder that may lead to mental

  retardation and or death if left untreated.
• Newborn screening tests are done by measuring metabolites and enzyme activity in whole blood samples collected on specialized filter paper.
• Procedure used for newborn screening is heel prick method
• Who may collect the samples?

  • physician
  • nurse
  • midwife
  • medtech
• Newborn screening (NBS) is an essential public health strategy that enables the early detection and management of several congenital disorders, which if left untreated, may lead to mental retardation and/or death.
• In the Philippines, it is a service available since 1986
• Globally 2.3 million children died in the first 2 days of life in 2022.
• There are approximately 6,500 newborn deaths every day, amounting to 47% of all child deaths under the age of 5 years.
• Feb 22, 1996 - First organizational meeting attended by representatives from different PPS and POGS accredited hospitals in Metro Manila
• April 2, 1996 - Creation of the NBS Study group composed of Pediatric and OB-Gynecology consultants from participating hospitals.

  Project name: Philippine Newborn Screening Project
• June 27, 1996 - Commencement of the Philippine Newborn Screening

  Project in 24 participating hospitals (18 private and 6 government)
• June 1996 - Sep 1997 - Coordination with the New South Wales

  Newborn

  Screening Program in Australia for test performance and analysis
• Sep 18, 1997 - Start of operation of the Newborn Screening Laboratory at the National Institutes of Health, UP Manila
• Jan 20, 2004 - Issuance of the Presidential Proclamation No. 540,

  Subject: “Declaring the First Week of October of each year as “National Newborn Screening Awareness Week”
• April 7, 2004 - Enactment of RA 9288 known as the newborn screening act of 2004
• Oct 7, 2004 - Signing of the implementing rules and regulations of the newborn screening act
• Dec 2014 -Expanded Newborn Screening – inclusion of more than 20+ disorders in the NBS Panel of Disorders
• March 29, 2019 - Administrative Order No. 2014-0045-A, all

  infant born in accredited facilities shall be tested for ENBS test only
• RA 9288 Newborn Screening Act of 2004

  • Senate no. 2707 (feb 2, 2004)
  • House no. 6625 (feb 5, 2004)
  • Approval date (april 7, 2004)
  • Presidential proclamation no. 540 (Jan 20, 2004): Newborn screening week
  • Signed by: Pr. Gloria Macapagal- Arroyo
• SUMMARY OF RA 9288

  • Consists of 19 Sections
  • Five Articles

  1. General provisions : 1-3
  2. Def of terms : 4
  3. Newborn Screening: 5-9
  4. Implementation : 10-16
  5. Final Provisions: 17-19
• Elements of NBS

  1. Comprehensive [complete]
  2. Integrative
  3. Sustainable
  4. Collaborative [various agencies must work together]
• Objectives of NBS

  • Government integrates sustainable newborn screening; included in the services being offered in the hospital
• Objectives of NBS

  • Practitioners must know the obligations; discuss the advantages, significance, and other information related to the newborn screening
• Objectives of NBS

  • Parent/ Guardian must recognize the responsibilities to their children’s life [possibilities] and death.
• Heritable condition means any condition that can result in mental retardation, physical deformity, or death if left undetected or untreated which is usually inherited from genes of either of both parents
• Newborn means a child from the time of complete delivery to 30 days old
• parent education means the various means of providing parents or legal guardians information about newborn screening.
• Recall means 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.
• Health practitioner: inform the parents or legal guardian of the newborn of the availability, nature, and benefits of newborn screening prior to delivery
• Department of Health (DOH): appropriate notification and education
• NBS is performed after 24 hours of life but not later than 3 days from complete delivery
• NB intensive care: may be exempted from the 3 day requirement but must be tested by seven days of age
• NBS results will be available after 7 working days from the time samples are received. Lab results indicating high risk to heritable diseases that were screened (+) will be immediately communicated and subjected within 24 hours for confirmatory test
• Refusal to be tested for NBS test on the grounds of religious beliefs, but shall acknowledge in writing their understanding that refusal for testing places their baby at risk for undiagnosed heritable conditions
• Committee on NBS

  1. Chairman : Secretary of Health
  2. Vice Chairperson: Executive Director of NIH
  3. Members (6):

  • Undersecretary of the DILG
  • Executive Director of the Council for the Welfare of Children
  • Director of the NBS Reference Center
  • Three (3) representatives appointed by the Sec. of Health who shall be a pediatrician, obstetrician, endocrinologist, family physician, nurse or midwife, from either the public or private sector.
• Committee on NBS

  Term: three (3) representatives shall be appointed for a term of three (3) years, subject to their being reappointed for additional three (3) years period for each extension.
• Committee on NBS

  Meeting: at least twice a year. The NIH shall serve as the Secretariat of the Committee
• True or False: No Newborn Screening Center shall be allowed to

  operate unless it has been duly accredited by the NIH based on the standards set forth by the Committee.

  False. Duly accredited by DOH
• Every Newborn Screening Center shall:

  1. (i) have a certified laboratory performing all tests included in the newborn screening program,
  2. (ii) have a recall/follow up programs for infants found positive for any and all of the heritable conditions;
  3. (iii) be supervised and staffed by trained personnel who have been duly qualified by the NIH;
  4. (iv) submit to periodic announced or unannounced inspections by the Reference Center in order to evaluate and ensure quality Newborn Screening Center performance.
• The NIH shall establish a Newborn Screening Reference Center, which shall be responsible for the national testing database and case registries, training, technical assistance and continuing education for laboratory staff in all Newborn Screening Centers.