RA 9288

Republic Act no. 9288

An act promulgating a comprehensive policy and a national system for ensuring newborn screening.

Newborn Screening Act of 2004

RA 9288 is also known as

April 7, 2004

Date of approval of the RA 9288

Gloria Macapagal-Arroyo

RA 9288 was approved by?

National Newborn Screening System

it 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

Comprehensive Newborn Screening System

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

Inborn Error Metabolism

IEM stands for?

Follow up

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

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

Healthcare Practitioner

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

National Institute of Health

NIH stands for

UP Manila

Where is NIH located?

Newborn

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

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

Newborn Screening Reference Center

it acts as the Secretariat of the Advisory Committee on Newborn Screening

Parent Education

providing parents or 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

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 of the heritable condition

Section 1: short title

section 2: declaration of policy

Section 3: objectives

Section 4: Definition

What are the contents of section 1-5

SECTION 5: Obligation to Inform

What section:

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 availability, nature and benefits of newborn screening.

Department of Health (DOH)

Appropriate notification and education regarding the "obligation to inform" shall be the responsibility of the ________________________

24 hours; 3 days

For normal delivery: newborn screening shall be performed after ___________ of life but not later than ____________ from complete delivery of the newborn.

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 ________________.

Performance of Newborn Screening

Title of Section 6

Department of Health

An appropriate informational brochure for parents to assist in fulfilling this responsibility shall be made available by the _____________________________ and shall be distributed to all health institutions and made available to any health practitioner requesting it for appropriate distribution.

SECTION 7: Refusal to be Tested

What section:

A parent or legal guardian 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. 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.

SECTION 8: Continuing Education, Re-education, and Training Health Personnel

What section:

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

a) conduct continuing information, education, re-education and training programs for health personnel on the rationale, benefits, procedures of newborn screening

b) disseminate information materials on newborn screening at least annually to all health personnel involved in material and pediatric care

SECTION 9: Licensing and Accreditation

What section:

The DOH and the Philippine Health Insurance Corporation (PHIC) shall require health institutions to provide newborn screening services as a condition for licensure or accreditation.

Department of Health and Philippine Health Insurance Corporation

These agencies require health institutions to provide newborn screening services as a condition for licensure or accreditation

Department of Health

Who is the lead agency in implementing RA 9288?

180 days

According to Section 10:

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)

According to Section 10:

Coordinate with the ___________________________ for implementation of the newborn screening program

NIH Newborn Screening Reference Center

According to Section 10:

Coordinate with the ____________________________ for the accreditation of Newborn Screening Centers and preparation of defined

testing protocols and quality assurance programs.

8 members

The Committee shall be composed of

Secretary of Health

Who acts as the Chairman of the Committee?

Executive Director of the NIH

Who shall act as the Vice Chairperson of the Committee?

- Undersecretary of the DILG

- Executive Director of the Council for the Welfare of Children

- Director of the Newborn Screening Reference Center;

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

Aside from the Chairman and Vice Chairperson of the Committee, who shall be the other members?

Pediatrician

Obstetrician

Endocrinologist

Family physician

Nurse

Midwife

The 3 representatives appointed by the Secretary of Health for Committee members shall be?

SECTION 11: Advisory Committee on Newborn Screening

What section:

To 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. The Committee shall review annually and recommend conditions to be included in the newborn screening panel of disorders; review and recommend the newborn screening fee to be charged by Newborn Screening Centers; review the report of the Newborn Screening Reference Center on the quality assurance of the National Screening Centers and recommend corrective measures as deemed necessary.

3 years; 3 years

The three (3) representatives shall be appointed for a term of ______________, subject to their being reappointed for additional _______________ period for each extension.

twice

The Committee shall meet at least __________ a year.

Secretariat of the Committee

The NIH shall serve as the

SECTION 12: Establishment and Accreditation of Newborn Screening Centers

What section:

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

SECTION 13: Establishment of a Newborn Screening Reference Center

What section:

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.

Newborn Screening Reference Center

The NIH shall establish a _____________________________, 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.

SECTION 14: Quality Assurance

What section:

The NIH Newborn Screening Reference Center shall be responsible for drafting and ensuring good laboratory practice standards for newborn screening centers, including establishing an external laboratory proficiency testing and certification program. It shall also act as the principal repository of technical information relating to newborn screening standards and practices, and shall provide technical assistance to newborn screening centers needing such assistance.

1 year

A plan for long-term outcome evaluation of newborn screening utilizing the cases registries shall be developed within _____________ of passage of this Act by the NIH Newborn Screening Reference Center in consultation with the Advisory Committee on Newborn Screening.

SECTION 15: Database

What section:

All Newborn Screening Centers shall coordinate with the NIH Newborn Screening Reference Center for consolidation of patient databases. The NIH Newborn Screening Reference Center shall maintain a national database of patients tested and a registry for each condition.

SECTION 16: Newborn Screening Fees

What section:

The PHIC shall include cost of newborn screening in its benefits package. The newborn screening fee shall be applied to, among others, testing costs, education, sample transport, follow-up and reasonable overhead expenses.

4 percent

To ensure sustainability of the National System for Newborn Screening, the newborn screening fee shall be divided and set aside for the following purposes; at least ____________ to the DOH's Centers for Health Development, to the Newborn Screening Centers, and to the NIH Newborn Screening Reference Center

✓ Registered Medical Technologists

✓ Registered Nurses

✓ Licensed Physician

✓ Registered Midwife

Who can collect blood for Newborn Screening?

Capillary puncture

What is the method used in collecting sample for NBS Test?

Whole blood

What is the specimen used for NBS Test?

refusal letter

Refusal is allowed provided that parents present a?

UP-National Institute of Health

Reference Center for Newborn Screening

G-6-PD deficiency

most common newborn disorder in the Philippines

DOH Memorandum No. 2012-0154

inclusion of Maple Syrup Urine Disease (MSUD) in the newborn panel of disorders

✓ Congenital Hypothyroidism

✓ Congenital Adrenal Hyperplasia

✓ Phenylketonuria

✓ G-6-Pd Deficiency

✓ Galactosemia

✓ Maple Syrup Urine Disease (MSUD)

Newborn screening program in the Philippines currently includes screening of the six disorders, which are:

P550

Fee for 6 Disorder screening (non PhilHealth members)

P1,500

Fee for Expanded NBS (non PhilHealth members)

P550 covered by PhilHeath; balance at the expense of family

For PhilHealth members:

How much is the fee for Expanded Newborn Screening

FREE / covered (by PhilHealth)

For PhilHealth member the fee for screening for 6 disorders shall be?

P550

Maximum allowable fee/cost for NBS Specimen Collection Kit

P50

Maximum allowable service fee for collection of NBS Samples