NEWBORN SCREENING ACT OF 2004

RA 9288

Newborn Screening Act of 2004

Senate and the House of Representatives

In the Philippines, the______ enacted Republic Act No. 9288 otherwise known as the Newborn Screening Act of 2004.

newborn screening test

is non-diagnostic because a series of follow-up procedures should be made to clarify abnormal results.

ferric chloride, sodium nitroprusside, clinitest, and Guthrie tests

The newborn screening is usually subject to laboratory examination. Both urine and blood samples are collected, and a series of laboratory tests are performed_______

RA 9288

It mandates the newborn screening procedure as it is a national policy in favour of the child’s health.

objectives of the National Newborn Screening System

• To 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;

• To establish and integrate a sustainable newborn screening system within the public health delivery system;

• To 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;

• To 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.

Comprehensive newborn screening system

(means a newborn screening system that includes, but is not limited to, 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; drugs and medical/surgical management and dietary supplementation to address the heritable conditions; and evaluation activities to assess long term outcome, patient compliance and quality assurance

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

refers to hospitals, health infirmaries, health centers, lying-in centers or puericulture centers with obstetrical and pediatric services, whether public or private.

Healthcare practitioner

refers to 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

the 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

a 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.

Newborn screening reference center

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 in all aspects of the program, oversees content of educational materials and acts as the secretariat of the advisory committee on newborn screening.

Parent education

the 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 to confirm the diagnosis and, as appropriate, provide treatment.

Treatment

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

24 hours of life but not later than 3 days from complete delivery of the newborn.

Newborn screening shall be performed after_____

7 days of age

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

For purposes of achieving the objectives of this Act, the DOH shall:

• 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 (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.

At a minimum, every Newborn Screening Center shall:

• 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; and

• submit to periodic announced or unannounced inspections by the Reference Center in order to evaluate and ensure quality Newborn Screening Center performance.

15 days, 2 newspapers of general circulation

This Act shall take effect________ after its publication in at least________

April 7, 2004

RA 9288 was approved on

Gloria Macapagal-Arroyo

RA 9288 is under his/her term

Franklin Drilon

President of the Senate in RA 9288

Jose De Vencia Jr.

Speaker of the House of Representatives in RA 9288

hemoglobinopathies

is a condition associated with abnormal heme synthesis, haemoglobin variants, and globin synthesis.

porphyrias

characterized by a defect in one or more enzymes involved in heme synthesis resulting in the accumulation of porphyrin in the bone marrow or the liver.

sickle cell disease

is a clinical condition in which erythrocytes become rigid and trapped in capillaries.

Hemoglobin C disease

having an amino acid substitution lysine for glutamic acid on the sixth position of the beta chain

Hemoglobin SC disease

double heterozygous condition in which an abnormal S gene from one parent is inherited and an abnormal C gene for another parent is also inherited.

Hemoglobin D disease

having an amino acid substitution glutamine at the 121st position of the beta chain.

Hemoglobin constant spring

is characterized by having 31 amino acid added to the alpha chain. Clinically resembles alpha thalassemia

Thalassemia

clinical condition whose predominant cause is gene deletion. Alpha and Beta thalassemia are the most common.

congenital hypothyroidism

characterized by the absence or poor functioning of the thyroid gland, resulting in the reduced production of thyroxine (increased thyroid stimulating hormones).

classic adrenal hyperplasia

clinical disorder characterized by a deficiency of the enzyme steroid 21-hydroxylase which comes in two forms, namely simple virilizing and salt-wasting.

phenylketonuria

most common form of amino acid disorder, This is an

inherited autosomal recessive disorder characterized by a deficiency in

phenylalanine hydroxylase (converting phenylalanine into tyrosine).

medium chain acyl-CoA dehydrogenase deficiency

one of the most recently disovered fatty acid oxidation disorder

cystic fibrosis

It is considered an autosomal recessive disorder which is characterized by a thick mucus in the lungs and digestive system resulting in respiratory infection and difficulty in food digestion.