RA 9288

NEWBORN SCREENING ACT OF 2004

aka RA 9288

institutionalize a national newborn screening system

Declaration of Policy

•The State shall _________________________________ that is comprehensive, integrative and sustainable, and will facilitate collaboration among government and non-government agencies at the national and local levels, the private sector, families and communities, professional health organizations, academic institutions, and non-governmental organizations

protect and promote the right to health of the people

Declaration of Policy

•The State shall _______________________, including the rights of children to survival and full and healthy development as normal individuals

opportunity to undergo newborn screening

Declaration of Policy

•National Newborn Screening System shall ensure that every baby born in the Philippines is offered the _______________________ and thus be spared from heritable conditions that can lead to mental retardation and death if undetected and untreated

access to newborn screening for certain heritable conditions

Objectives

1)To ensure that every newborn has ________________________ that can result in mental retardation, serious health complications or death if left undetected and untreated;

sustainable newborn screening system

Objectives

2)To establish and integrate a _________________________ within the public health delivery system;

aware of the advantages of newborn screening

Objectives

3)To ensure that all health practitioners are __________________________________ and of their respective responsibilities in offering newborns the opportunity to undergo newborn screening; and

responsibility in promoting their child's right to health and full development

Objectives

4)To ensure that parents recognize their ___________________________, within the context of responsible parenthood, by protecting their child from preventable causes of disability and death through newborn screening.

Comprehensive Newborn Screening System

DEFINITION OF TERMS

•newborn screening system that includes, but is not limited to:

a.education of relevant stakeholders
b.collection and biochemical screening of blood samples taken from newborns
c.tracking and confirmatory testing to ensure the accuracy of screening results
d.clinical evaluation and biochemical/medical confirmation of test results
e.drugs and medical/surgical management and dietary supplementation to address the heritable conditions
f.evaluation activities to assess long term outcome, patient compliance and quality assurance

Follow-up

DEFINITION OF TERMS

•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

DEFINITION OF TERMS

•hospitals
•health infirmaries
•health centers
•lying-in centers or puericulture centers with obstetrical and pediatric services (public or private)

Healthcare practitioner

DEFINITION OF TERMS
•physicians
•nurses
•midwives
•nursing aides
•traditional birth attendants

Heritable condition

DEFINITION OF TERMS

•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

National Institute of Health

DEFINITION OF TERMS

NIH

Newborn

DEFINITION OF TERMS

child from the time of complete delivery to 30 days old

Newborn Screening

DEFINITION OF TERMS

•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

DEFINITION OF TERMS

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

DEFINITION OF TERMS

central facility at the NIH that:

a.defines testing and follow-up protocols
b.maintains an external laboratory proficiency testing program
c.oversees the national testing database and case registries
d.assists in training activities in all aspects of the program
e.oversees content of educational materials
f.acts as the Secretariat of the Advisory Committee on Newborn Screening

Parent education

DEFINITION OF TERMS

various means of providing parents or legal guardians information about newborn screening

Recall

DEFINITION OF TERMS

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

DEFINITION OF TERMS

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

Performance of Newborn Screening

performed after ___________________ from complete delivery of the newborn

3-day requirement but must be tested by 7 days of age

Performance of Newborn Screening

newborn is placed in intensive care in order to ensure survival may be exempted from the _________________
________________

joint responsibility

Performance of Newborn Screening

shall be the ________________ of the parent(s) and the practitioner or other person delivering the newborn

informational brochure

Performance of Newborn Screening

an appropriate _______________________ for parents to assist in fulfilling this responsibility shall be made available by the Department of Health and shall be distributed to all health institutions and made available to any health practitioner requesting it for appropriate distribution

parent or legal guardian

Refusal to be Tested

a ______________________ 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

newborn's medical record

Refusal to be Tested

a copy of this refusal documentation shall be made part of the _____________________ and refusal shall be indicated in the national newborn screening database

national newborn screening database

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 ___________________________________________.

conduct continuing information, education, re-education and training programs

Continuing Education, Re-education and Training Health Personnel

DOH, with the assistance of the NIH and other government agencies, professional societies and non-government organizations, shall:

a. ____________________________________ for health personnel on the rationale, benefits, procedures of newborn screening

disseminate information materials

Continuing Education, Re-education and Training Health Personnel

DOH, with the assistance of the NIH and other government agencies, professional societies and non-government organizations, shall:

a.___________________________ on newborn screening at least annually to all health personnel involved in material and pediatric care

Licensing and AccreditationDOH and the Philippine Health Insurance Corporation (PHIC)

Licensing and Accreditation

_________________ shall require health institutions to provide newborn screening services as a condition for licensure or accreditation

DOH

IMPLEMENTATION
Lead Agency

The ___________ shall be the lead agency in implementing this Act. For purposes of achieving the objectives of this Act, the DOH shall:

Advisory Committee on Newborn Screening

IMPLEMENTATION
Lead Agency

The DOH shall be the lead agency in implementing this Act. For purposes of achieving the objectives of this Act, the DOH shall:

establish the _______________

develop the implementing rules and regulations

IMPLEMENTATION
Lead Agency

The DOH shall be the lead agency in implementing this Act. For purposes of achieving the objectives of this Act, the DOH shall:

____________________ 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)

IMPLEMENTATION
Lead Agency

The DOH shall be the lead agency in implementing this Act. For purposes of achieving the objectives of this Act, the DOH shall:

______________________________ for implementation of the newborn screening program

coordinate with the NIH Newborn Screening Reference Center

IMPLEMENTATION
Lead Agency

The DOH shall be the lead agency in implementing this Act. For purposes of achieving the objectives of this Act, the DOH shall:

____________________________ for the accreditation of Newborn Screening Centers and preparation of defined testing protocols and quality assurance programs

Advisory Committee on Newborn Screening

ensure sustained inter-agency collaboration, the Advisory Committee on Newborn Screening is hereby created and made an integral part of the Office of the Secretary of the DOH

review annually and recommend conditions to be included

Advisory Committee on Newborn Screening

The Committee shall:
a. _______________________________ in the newborn screening panel of disorders

review and recommend the newborn screening fee

Advisory Committee on Newborn Screening

b. __________________________ to be charged by Newborn Screening Centers

review the report of the Newborn Screening Reference Center on the quality assurance

Advisory Committee on Newborn Screening

c. _________________________ of the National Screening Centers and recommend corrective measures as deemed necessary

1.Secretary of Health who shall act as Chairman

2.the Executive Director of the NIH, who shall act as Vice Chairperson

3.Undersecretary of the DILG

4.Executive Director of the Council for the Welfare of Children

5.Director of the Newborn Screening Reference Center

6.three (3) representatives appointed by the Secretary of Health who shall be a pediatrician, obstetrician, endocrinologist, family physician, nurse or midwife, from either the public or private sector

Advisory Committee on Newborn Screening

The Committee shall be composed of 8 members:

3 representatives

Advisory Committee on Newborn Screening

NOTE: The ________________ shall be appointed for a term of 3 years, subject to their being reappointed for additional 3 years period for each extension.

at least twice a year

Advisory Committee on Newborn Screening


The Committee shall meet __________________.

Secretariat of the Committee

Advisory Committee on Newborn Screening

The NIH shall serve as the __________________.

DOH

Establishment and Accreditation of Newborn Screening Centers

Ø shall ensure that Newborn Screening Centers are strategically located in order to be accessible to the relevant public and provide services that comply with the standards approved by the Committee upon the recommendation of the NIH

No Newborn Screening Center

Establishment and Accreditation of Newborn Screening Centers

________________________ shall be allowed to operate unless it has been duly accredited by the DOH based on the standards set forth by the Committee

certified laboratory

Establishment and Accreditation of Newborn Screening Centers

At a minimum, every Newborn Screening Center shall:

have a _________________ performing all tests included in the newborn screening program

recall/follow up programs

Establishment and Accreditation of Newborn Screening Centers

At a minimum, every Newborn Screening Center shall:

have a _________________________ for infants found positive for any and all of the heritable conditions

supervised and staffed by trained personnel

Establishment and Accreditation of Newborn Screening Centers

At a minimum, every Newborn Screening Center shall:

be _____________________________ who have been duly qualified by the NIH

submit to periodic announced or unannounced inspections

Establishment and Accreditation of Newborn Screening Centers

At a minimum, every Newborn Screening Center shall:
______________________ by the Reference Center in order to evaluate and ensure quality Newborn Screening Center performance

NIH

Establishment of a Newborn Screening Reference Center

____________________: 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

responsible for drafting and ensuring good laboratory practice standards

Quality Assurance
NIH Newborn Screening Reference Center

o shall be ____________________ for newborn screening centers, including establishing an external laboratory proficiency testing and certification program

act as the principal repository of technical information

Quality Assurance
NIH Newborn Screening Reference Center

o shall ________________________ relating to newborn screening standards and practices, and shall provide technical assistance to newborn screening centers needing such assistance

Database

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

maintain a national database

Database

NIH Newborn Screening Reference Center:

_____________________ of patients tested and a registry for each condition

annually to the Committee and to the DOH

Database

NIH Newborn Screening Reference Center:

submit reports ______________________ on the status of and relevant health information derived from the database

plan for long-term outcome evaluation

Database

NIH Newborn Screening Reference Center:

________________________ of newborn screening utilizing the cases registries shall be developed within 1 year of passage of this Act in consultation with the Advisory Committee on Newborn Screening

Advisory Committee on Newborn Screening

Database

NIH Newborn Screening Reference Center:

NOTE: Implementation of this plan shall become a responsibility of the _________________________.

congenital hypothyroidism (CH)
congenital adrenal hyperplasia (CAH)
phenylketonuria (PKU)
glucose-6- phosphate dehydrogenase (G6PD) deficiency
galactosemia (GAL)
maple syrup urine disease (MSUD)

Newborn Screening Program

includes screening of six disorders:

22

Newborn Screening Program

The expanded screening will include _______ more disorders such as hemoglobinopathies and additional metabolic disorders, namely, organic acid, fatty acid oxidation, and amino acid disorders

Hypothyroidisim

Newborn Screening Program
includes screening of six disorders:

radioactive iodine; surgery

Adrenal hyperplasia

Newborn Screening Program
includes screening of six disorders:

mutations in genes that code for enzymes involved in making steroid hormones

Phenylketonuria

Newborn Screening Program
includes screening of six disorders:

decreased metabolism of the amino acid phenylalanine; musty smell and lighter skin

maple syrup urine disease (MSUD)

Newborn Screening Program
includes screening of six disorders:

autosomal recessive; sweet odor of affected infants' urine

phenylketonuria (PKU)
methylmalonic acidemia
maple syrup urine disease (MSUD)
tyrosinemia
citrullinemia
medium chain acyl CoA dehydrogenase (MCAD) deficiency

Metabolic Problems

congenital hypothyroidism
congenital adrenal hyperplasia

Hormone Problems

sickle cell disease
hemoglobin SC disease
beta thalassemia

Hemoglobin Problems

galactosemia
biotidinase deficiency
cystic fibrosis
severe combined immunodeficiency (SCID)
Pompe disease (glycogen storage disease type II)
mucopolysaccharidosis type 1
X-linked adrenoleukodystropy
spinal muscle atrophy (SMA)
hearing loss
congenital heart disease

Other Problems

PHIC

Newborn Screening Fees

______________: include cost of newborn screening in its benefits package

PHIC

Newborn Screening Fees

shall be applied to, among others, testing costs, education, sample transport, follow-up and reasonable overhead expenses

at least 4%

Newborn Screening Fees

To ensure sustainability of the National System for Newborn Screening, the newborn screening fee shall be divided and set aside for the following purposes:

________________ 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

operational and other expenses

Newborn Screening Fees

To ensure sustainability of the National System for Newborn Screening, the newborn screening fee shall be divided and set aside for the following purposes:

balance for the ____________________ of the Newborn Screening Center