Newborn Screening Act of 2004

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Newborn Screening is a simple procedure to determine whether a baby has congenital metabolic disorder that may lead to mental retardation and even death if left untreated.

Introduction

Congenital hypothyroidism (CH) y Congenital adrenal hyperplasia (CAH) y Galactosemia (GA) y Phenylketonuria (PKA) y Glucose-6-phosphate dehydrogenase deficiency (G6PD def)
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Disorders included

Deficiency in the production of thyroid hormone y Prevalence: 1:3,350 y Poor growth, mental retardation, deafness and neurological abnormalities can result without prompt identification and treatment. y Early diagnosis and adequate treatment with thyroxine within the first weeks of life results in normal growth and intelligence.
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Congenital hypothyroidism

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A group of inherited disorders caused by abnormalities in specific enzymes of the adrenal gland Ninety percent of congenital adrenal hyperplasia cases are caused by the lack of the enzyme steroid 21-hydroxylase Prevalence: 1:13,500 Babies with untreated congenital adrenal hyperplasia may develop vomiting and severe dehydration (aldosterone deficient, salt-wasting CAH), which can be life threatening Increased production of androgens can result in ambiguous genitalia in infants

Congenital adrenal hyperplasia

Autosomal recessive disorder caused by the lack of phenylalanine hydroxylase, the enzyme that converts the amino acid phenylalanine to tyrosine Prevalence: 1:20,000 y Without early diagnosis and strict adherence to a special diet, brain damage and mental retardation can occur y Phenylalanine is present in almost all foods
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Phenylketonuria

Galactosemia

Autosomal recessive disorder y Primary form is a deficiency of GALT galactose-1-phosphate uridyl transferase enzyme needed to break down the milk sugar lactose y Prevalence: 1:60,000 y Life-threatening galactosemia, mental retardation,and blindness can occur y Clinical symptoms may present as early as the first week of life.
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Newborn screening is done on the 48 hours or at least 24 hours from birth. y The baby must be screened again after 2 weeks for more accurate result. y A physician, medical technologist, nurse, a midwife can collect sample for newborn screening. y A few drops of blood are obtained from the baby¶s heel and blotted on a special absorbent filter card.
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Act promulgating a comprehensive policy and a national system for ensuring newborn screening.

Republic Act no. 9288

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Section 1: Short Title:
³Newborn Screening Act of 2004´

Section 2:

Declaration of Policy

The state shall 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. The state shall institutionalize a national newborn screening system that is comprehensive, integrative, and sustainable and will facilitate collaboration among government and nongovernment agencies at the national and local levels, the private sector, families and communities, professional health organizations, academic institutions, and NGOs

Article 1: General Provision

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The national newborn screening shall ensure that every baby born in the Philippines is offered the opportunity to undergo newborn screening and thus be spared from heritable conditions that can lead to mental retardation and death if undetected and untreated.

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Section 3: Objectives:
Ensure that every newborn has access to newborn screening for certain heritable conditions that can result in mental retardation, serious health complications or death if left undetected and untreated. Establish and integrate a sustainable newborn screening system within the public health delivery system. Ensure that all health practitioners are aware of the advantages of newborn screening and of their respective responsibilities in offering newborns the opportunity to undergo newborn screening.

Article 1: General Provisions

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Section 3: Objectives:
Ensure that parents recognize their responsibility in promoting their child¶s right to health and full development, within the context of responsible parenthood, by protecting their child from preventable causes of disability and death through newborn screening.

Article 1: General Provision

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Comprehensive Newborn Screening System:
Education of relevant stakeholders Collection and biochemical screening of blood Tracking and confirmatory testing Clinical evaluation and biochemical/medical confirmation of test results Drugs and medical/surgical management and dietary supplementation to address the heritable conditions Evaluation of activities to assess long term outcome Patient outcome and quality assurance.

Article 2: Definition of Terms

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Follow-up:
Monitoring of a newborn

Health Institutions:
Hospital, health infirmaries, health centers, lying-in centers, puericulture centers (public or private)

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Health care practitioners:
Physicians, nurses, midwives, nursing aides, and traditional birth attendants.

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Heritable condition:
Condition that can result in mental retardation, physical deformity or death.

Article 2: Definition of Terms

NIH: National Institute of Health y Newborn:
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Means a child from the time of complete delivery to 30 days old.
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Newborn screening:
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.

Article 2: Definition of Terms

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Newborn Screening Center:
Facility equipped with a newborn screening laboratory that complies with the standards.

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Newborn Screening Reference Center:
Central facility at the NIH that defines testing and follow up protocols, maintains an external laboratory proficiencies and national database.

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Parent Education:
Various means of providing parents or legal guardians information

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Recall:
Procedure of locating a newborn

Article 2: Definition of Terms

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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.

Article 2: Definition of Terms

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Section 5: Obligation to inform
Health practitioner informs the parents or legal guardian of the newborn of the availability, nature and benefits of newborn screening. Education and notification ± responsibility of the DOH.

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Section 6: Screening

Performance of Newborn

Shall be performed after 24 hours of life but not later than 3 days from complete delivery of the newborn

Article 3: Newborn screening

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Section 6: Performance. . . (cont.)
Newborn in the ICU ± may be exempted from the 3-day requirement but must be tested by 7 days of age. Shall be the joint responsibility of the parent(s) and the practitioner or other person delivering the newborn to ensure that newborn screening is performed.

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Section 7: Refusal to be Tested
A parent or legal guardian may refuse testing on the grounds of religious beliefs, but shall acknowledge in writing their newborn at risk for undiagnosed heritable conditions.

Article 3: Newborn screening

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Section 7: (Refusal . . . Cont.)
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.

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Section 8: Continuing Education, Reeducation and Training Health Personnel
DOH with the assistance of the NIH conduct continuing information, education, reeducation, and training programs for health personnel on the rationale, benefits, procedures of newborn screening.

Article 3: Newborn Screening

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Section 8: Continuing Education, Reeducation and Training Health Personnel (cont.)
Disseminate information materials on newborn screening at least annually to all health personnel involved in maternal and pediatric care.

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Section 9: Licensing and Accreditation
DOH and the Phil Health Insurance Corporation (PHIC) shall require health institutions to provide newborn screening services as a condition for licensure or accreditation.

Article 3: Newborn Screening

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Section 10: Lead Agency
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 eight (108) days from the enactment of this Act. Coordinate with the department of the interior and local government (DILG) for the implementation of the NBS programs.

Article 4: Implementation

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Section 10: Lead Agency
Lead Agency: DOH Advisory Committee on Newborn Screening Coordinate with the NIH NBS Reference Center for the accreditation of Newborn screening centers and preparation of defined testing protocols and quality assurance programs. Coordinate with DILG for implementation of the NBS program.

Article 4: Implementation

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Section 11: Advisory Committee on Newborn Screening
Ensure sustained inter-agency collaboration Integral part of the office of the secretary of the DOH Review annually and recommend conditions to be included in the newborn screening panel of disorders Review and recommend the newborn screening fee.

Article 4: Implementation

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Section 11:
Committee: 8 members:
x Chairman: Secretary of the DOH x Executive director of the NIH, who shall act as Vice Chairman x Undersecretary of the DILG x Executive Director of the Council for the Welfare of Children x Director of the Newborn Screening Reference Centers x 3 representatives appointed by the Secretary of Health (pediatrician, obstetrician, endrocrinologist, family physician, nurse or midwife) ± term: 3 years subject for reappointment for another 3 years. x NIH: secretariat of the committee

Article 4: Implementation

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Section 12: Establishment and Accreditation of Newborn Screening Centers

Strategically located and accessible Certified laboratory performing all tests included in the newborn screening program 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 and unannounced inspections by the Reference Article 4: Implementation center.

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Section 13: Establishment of a Newborn Screening Reference Center
NIH shall establish a NBS Reference Center
x National testing database x Case registries, training, technical assistance x Continuing education for laboratory staff

Article 4: Implementation

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Section 14: Quality Assurance
NIH:
x Responsible for drafting and ensuring good laboratory practice standards for newborn screening centers x Establish an external laboratory proficiency testing and certification program x Principal repository of technical information relating to newborn screening standards and practices x Technical assistance to newborn screening centers needing such assistance.

Section 4: Implementation

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Section 15: Database
NBS Reference center shall maintain a national database of patients tested and a registry for each condition. NBS Reference center shall submit reports annually to the committee and to the DOH on the status of an relevant information derived from the database

Article 4: Implementation

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Section 16: Newborn Screening Fees
Testing costs Education Sample transport Follow-up cost Reasonable overhead expenses

Article 4: Implementation

Section 17: Repealing Clause y Section 18: Separability Clause y Section 19: Effectivity
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Article 5: Final Provisions

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