ra 9288: newborn screening act of 2004

Newborn Screening Act of 2004

Newborn Screening Act of 2004

RA 9288

1st Week of October

### Proclamation No. 540:

National Newborn Screening Week

Gloria Macapagal-Arroyo

President

April 7, 2004

Approval Date

Newborn Screening (NBS)

a simple procedure to find out **if a baby has a congenital disorder** that may lead to mental retardation or even death if left untreated

Most babies with metabolic disorders look “**normal**” at birth

Why is NBS important?

**Not Screened:**

* Developmental delay
* Breathing problems
* Neurologic damage
* Seizures
* Coma
* Early death

**Screened:**

* Alive
* Normal development with episodes of metabolic crisis

### Newborn Screening Effects:

Organic Acid Disorders

**Not Screened:**

* Severe Mental Retardation
* Death

**Screened:**

* Alive & normal

### Newborn Screening Effects:

Endocrine

**Not Screened:**

* Developmental and physical delays
* Neurologic impairment
* Sudden death
* Coma
* Seizure
* Enlargement of the heart & liver
* Muscle weakness

**Screened:**

* Healthy in between episodes of metabolic crises

### Newborn Screening Effects:

Fatty Acids Oxidation

**Not Screened:**

* Painful Crise
* Anemia Stroke
* Multi-organ failure
* Death

**Screened:**

* Alive
* Reduced frequency of painful crises
* Reduced need for blood transfusions.

### Newborn Screening Effects:

Hemoglopathies

**Not Screened:**

* Seizure
* Mental Retardation
* Death

**Screened:**

* Alive & normal

### Newborn Screening Effects:

Urea Cycle Defect

**Not Screened:**

* Mental Retardation
* Coma
* Death

**Screened:**

* Alive & normal

### Newborn Screening Effects:

Amino Acid Disorder

Comprehensive Newborn Screening (NBS) Program

integrated as part of the country’s public health delivery system

Department of Health (DOH)

**lead agency** in the implementation of the law and collaborates with other National Government Agencies (NGA) and key stakeholders to __ensure early detection and management of several congenital metabolic disorders__

congenital hypothyroidism

### Screening of Six Disorders:


1. CH

congenital adrenal hyperplasia

### Screening of Six Disorders:


2. CAH

phenylketonuria

### Screening of Six Disorders:


3. PKU

glucose-6-phosphate dehydrogenase deficiency

### Screening of Six Disorders:


4. G6PD

galactosemia

### Screening of Six Disorders:


5. GAL

maple syrup urine disease

### Screening of Six Disorders:


6. MSUD

**National Policy and Strategic Framework** on Expanded Newborn Screening for 2017-2030

### Policies and Laws:

Administrative Order No. **2018-0025**

Guidelines on the Implementation of the **Expanded** Newborn Screening Program

### Policies and Laws:

Administrative Order No. **2014-0045**

22 more disorders:

* hemoglobinopathies
* organic acid
* fatty acid oxidation
* amino acid disorders

The expanded screening will include ___

University of the Philippines Manila

### Newborn Screening Centers:

NIH

Visayas State University Medical Center, Iloilo City

### Newborn Screening Centers:

Visayas

Southern Philippines Medical Center, Davao City

### Newborn Screening Centers:

Mindanao

Angeles City, Pampanga

### Newborn Screening Centers:

Central Luzon

Tanauan City, Batangas

### Newborn Screening Centers:

Southern Luzon

Batac City, Ilocos Norte

### Newborn Screening Centers:

Northern Luzon

immediately **after 24 hours from birth**

When is it 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)

How is it done?

* physician
* nurse
* medical technologist
* trained midwife

Who will collect the sample?

* **State shall institutionalize a national newborn screening system** that is __comprehensive, integrative and sustainable, and will facilitate collaboration among government and non-government agencies__
* 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__

### Section 2. *Declaration of Policy*

access

### Section 3. *Objectives*


1. To ensure that every newborn has ___ to newborn screening for certain heritable conditions

public health delivery system

### Section 3. *Objectives*


2. To establish and integrate a sustainable newborn screening system within the ___

health practitioners

### Section 3. *Objectives*


3. To ensure that all ___ are aware of the advantages of newborn screening and of their respective responsibilities

parents

### Section 3. *Objectives*


4. To ensure that ___ 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

Follow-up

### Section 4. *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

Heritable condition

### Section 4. *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**

National Institute of Health

### Section 4. *Definition of Terms*

NIH

Newborn

### Section 4. *Definition of Terms*

a child from the time of complete delivery to **30 days old**

Newborn Screening Center

### Section 4. *Definition of Terms*

a **facility equipped with a newborn screening laboratory** and provides all required laboratory tests and recall/follow-up programs for newborns with heritable conditions

Newborn Screening Reference Center

### Section 4. *Definition of Terms*

* the **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
* **Secretariat** of the Advisory Committee on Newborn Screening

Parent education

### Section 4. *Definition of Terms*

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

Recall

### Section 4. *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

### Section 4. *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

availability, nature and benefits of newborn screening

### Section 5. *Obligation to Inform*

**Any health practitioner** who delivers, or assists in the delivery, of a newborn in the Philippines shall, prior to delivery, **inform the parents or legal guardian** of the newborn of the ___

three (3) days

### Section 6. *Performance of NBS*

shall be performed **after twenty-four (24) hours** of life but not later than ___

newborn placed in **intensive care**

### Section 6. *Performance of NBS*

may be __exempted from the 3-day requirement__ but must be **tested by seven (7) days of age**

religious beliefs

### Section 7. *Refusal to be Tested*

A parent or legal guardian may refuse testing on the grounds of ___, but __shall acknowledge in writing__ their understanding that refusal for testing places their newborn at risk for undiagnosed heritable conditions

Continuing Education, Re-Education, and Training Programs

### Section 8. *Continuing Education, Re-Education, and Training in Health Personnel*


1. conduct ___ for health personnel on the rationale, benefits, procedures of newborn screening

annually

### Section 8. *Continuing Education, Re-Education, and Training in Health Personnel*


2. disseminate information materials on newborn screening at least ___ to all health personnel **involved in maternal and pediatric care**

DOH and the **Philippine Health Insurance Corporation**

### Section 9. *Licensing & Accreditation*

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

Advisory Committee

### Section 10. *Lead Agency*


1. Establish the ___ on Newborn Screening

one hundred eight (180) days

### Section 10. *Lead Agency*


2. Develop the **implementing rules and regulations** for the immediate implementation of a nationwide newborn screening program within ___ from the enactment of this Act

Department of the Interior and Local Government (DILG)

### Section 10. *Lead Agency*


3. for implementation of the newborn screening program

Newborn Screening Reference Center

### Section 10. *Lead Agency*


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

created and made an integral part of the Office of the Secretary of the DOH

### Section 11. *Advisory Committee on NBS*

To ensure sustained inter-agency collaboration, the Advisory Committee on Newborn Screening is hereby ___

Secretary of Health

### Section 11. *Advisory Committee on NBS*


1. Chairman

Executive Director of the NIH

### Section 11. *Advisory Committee on NBS*


2. Vice Chairperson

Undersecretary of the DILG

### Section 11. *Advisory Committee on NBS*


3. \

Executive Director of the Council for the Welfare of Children

### Section 11. *Advisory Committee on NBS*


4. \

Director of the Newborn Screening Reference Center

### Section 11. *Advisory Committee on NBS*


5. \

**three (3) representatives** appointed by the Secretary of Health

* pediatrician
* obstetrician
* endocrinologist
* family physician
* nurse or midwife

### Section 11. *Advisory Committee on NBS*

6-8

three (3) years

### Section 11. *Advisory Committee on NBS*

term of three (3) representatives

at least twice a year

### Section 11. *Advisory Committee on NBS*

Committee shall meet

strategically located

### Section 12. *Establishment & Accreditation of NBS Centers*

The DOH shall ensure that Newborn Screening Centers are ___ in order to be **accessible** to the relevant public and provide services that comply with the standards

**certified** laboratory

### Section 12. *Establishment & Accreditation of NBS Centers*


1. ___ performing all tests included in the newborn screening program

**recall/follow up programs** for infants found positive

### Section 12. *Establishment & Accreditation of NBS Centers*


2. ___ for any and all of the heritable conditions

**trained personnel** who have been duly qualified by the NIH

### Section 12. *Establishment & Accreditation of NBS Centers*


3. be supervised and staffed by ___

inspections

### Section 12. *Establishment & Accreditation of NBS Centers*


4. submit to periodic announced or unannounced ___ by the Reference Center in order __to evaluate and ensure quality__ Newborn Screening Center performance

* national testing database and case registries
* training
* technical assistance
* continuing education

### Section 13. *Establishment of NBSRC*

The NIH shall establish a Newborn Screening Reference Center, which shall be responsible for ___

laboratory practice standards

### Section 14. *Quality Assurance*

drafting and ensuring good ___ for newborn screening centers

principal repository

### Section 14. *Quality Assurance*

act as the ___ of technical information

long-term outcome evaluation

### Section 15. *Database*

* plan for ___ of newborn screening

four percent (4%) to the **DOH's Centers for Health Development**

### Section 16. *NBS Fees*

* solely for follow-up services, education and other activities directly related to the provision of newborn screening services

four percent (4%) to the Newborn Screening Centers

### Section 16. *NBS Fees*

* for human resource development and equipment maintenance and upgrading

four percent (4%) to the **NIH Newborn Screening Reference Center**

### Section 16. *NBS Fees*

* for overall supervision, training and continuing education, maintenance of national database, quality assurance program and monitoring of the national program