[MTLE] RA 9288: Newborn Screening Act

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.

Newborn Screening Act

RA 9288

Importance of Newborn Screening

Most babies with metabolic disorders look "normal" at birth.

By doing NBS, metabolic disorders may be detected even before clinical signs and symptoms are present.

As a result of this, treatment can be given early to prevent consequences of untreated conditions

Organic Acid Disorders

Endocrine Disorders

Fatty Acid Oxidation Disorder

Hemoglobinopathies

Urea Cycle Defect

Amino Acid Disorders

Organic Acid Disorders

endocrine Disorders

Fatty Acid Oxidation Disorder

Hemoglobinopathies

Urea Cycle Defect

Amino Acid Disorder

Disorders screened

1. congenital hypothyroidism (CH)

2. congenital adrenal hyperplasia (CAH)

3. phenylketonuria (PKU)

4. glucose-6-phosphate dehydrogenase (G6PD) deficiency

5. galactosemia (GAL)

6. maple syrup urine disease (MSUD)

6 common/initial disorders included in the newborn screening program of the Philippines

RA 9288

The law that defines the establishment and accreditation of Newborn Screening Centers (NSC)

6 operation NSCs in the country

1. Newborn Screening Center - NIH at the University of the Philippines Manila

2. Newborn Screening Center - Visayas located at West Visayas State University Medical Center, Iloilo City

3. Newborn Screening Center - Mindanao located at the Southern Philippines Medical Center, Davao City

4. Newborn Screening Center - Central Luzon in Angeles City, Pampanga

5. Newborn Screening Center - Southern Luzon in Tanauan City, Batangas

6. Newborn Screening Center - Northern Luzon in Batac City, Ilocos Norte

RA 9288

The Comprehensive Newborn Screening (NBS) Program was integrated as part of the country's public health delivery system with the enactment of the Republic Act no. ______ otherwise known as Newborn Screening Act of 2004.

DOH

+ NGAs

acts as the 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.

1st week of October

Proclamation No. 540 dated January 20, 2004 entitled "Declaring the 1st Week of ________ of Each Year as "National Newborn Screening Week"

Gloria Macapagal Arroyo

Approved the Newborn Screening Act

19 Sections

How many sections are there in RA 9288

April 7, 2004

Date of approval of newborn screening act of 2004

Newborn Screening Act of 2004

Title of RA 9288

Purposes of RA 9288

the State shall institutionalize a national newborn screening system that is comprehensive, integrative and sustainable, and will facilitate collaboration among government and non- government agencies, the private sector, families and communities, professional health organizations, academic institutions, and non-governmental organizations.

The National Newborn Screening System shall ensure that every baby born in the Philippines is offered the opportunity to undergo newborn screening

Objectives of RA 9288

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; and

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.

Follow up

means 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

Recall

means 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

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 availability, nature and benefits of newborn screening.

after 24 hours but not later than 3 days

Newborn Screening shall be performed when

(7) days of age

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 ______ days

parent(s) and the practitioner

Newborn screening is a joint responsibility of the ____________ or other person delivering the newborn to ensure that newborn screening is performed

religious beliefs;

acknowledge in writing

A parent or legal guardian may refuse testing on the grounds of ______, but shall ____________ their understanding that refusal for testing places their newborn at risk for undiagnosed heritable conditions.

DOH

(+ NIH)

Agency responsible for the education, reeducation and training of health personnel

NIH

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

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

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

DOH

PhilHealth

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

DOH

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

1) Establish the Advisory Committee on Newborn Screening

2) 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;

3) Coordinate with the Department of the Interior and Local Government (DILG) for implementation of the newborn screening program

4) 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.

Advisory Committee on Newborn Screening

Committee Established by the DOH for newborn screening

DILG

Partner of DOH for implementation of the newborn screening program

NIH

Partner of DOH for Newborn Screening Reference Center for the accreditation of Newborn Screening Centers and preparation of defined testing protocols and q

Advisory Committee on Newborn Screening

To ensure sustained inter-agency collaboration, the ______________ 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 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.

1) Review and recommendation of disorders screened

2) Review and recommend fee

3) Review the report of

4) Recommend corrective measures

keywords on 4 roles of

Advisory Committee on Newborn Screening

8 members

How many members are in the Advisory Committee on Newborn Screening

Secretary of Health - Chairman

Executive Director of the NIH - Vice Chairperson

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 who shall be a pediatrician, obstetrician, endocrinologist, family physician, nurse or midwife, from either the public or private sector

8 members of the Advisory Committee on Newborn Screening

3 Representatives appointed

They shall be appointed for a term of three (3) years, subject to their being reappointed for additional three (3) years period for each extension

twice a year

Meeting of advisory committee on newborn screening

NIH

will serve as the secretariat of the committee

DOH

agency that 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.

Newborn Screening Center

Roles are:

have a certified laboratory performing all tests included in thenewborn 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 havebeen 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

NIH

Newborn Screening Centers must be supervised and staffed by trained personnel who have been duly qualified by the ____; and

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

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.

NIH Newborn Screening Reference Center

Responsible for:

drafting and ensuring good laboratory practice standards for newborn screening centers,

establishing an external laboratory proficiency testing and certification program.

act as the principal repository of technical information relating to newborn screening standards and practices,

provide technical assistance to newborn screening centers

national database and registry

DOH

NIH Newborn Screening Reference Center shall maintain a national _____ of patients tested and a registry for each condition

submit reports annually to the Committee and to the ____ on the status of and relevant health information derived from the database

Plan for long-term outcome evaluation of newborn screening

NIH Newborn Screening Reference Center

plan for long-term outcome evaluation of newborn screening

Newborn Screening Fees

The newborn screening fee shall be divided and set aside for the following purposes

at least four percent (4%) to the DOH's Centers for Health Development or its future equivalent to be spent solely for follow-up services, education and other activities directly related to the provision of newborn screening services

at least four percent (4%) to the Newborn Screening Centers for human resource development and equipment maintenance and upgrading

at least four percent (4%) to the NIH Newborn Screening Reference Center for overall supervision, training and continuing education, maintenance of the national database, quality assurance program and monitoring of the national program

and the balance for the operational and other expenses of the Newborn Screening Center

4% o the DOH's Centers for Health Development

4% to the Newborn Screening Centers (HR, Equipment, Upgrade)

4% to the NIH Newborn Screening Reference Center

operational and other expenses of the Newborn Screening Center

Keywords on Fees

Repealing Clause

Separability Clause

Effectivity

Sections 17-18-19

Administrative Order No. 2014-0045

the Guidelines on the Implementation of the Expanded Newborn Screening Program

Administrative Order No. 2018-0025

National Policy andStrategic Framework on Expanded Newborn Screening for2017-2030

22

how many disorders are included in the expanded screening

hemoglobinopathies and

additional metabolic disorders, namely, organic acid, fatty acid oxidation, and amino acid disorders.

included disease in the expanded screened disorders

November 5, 2018

Date of expansion approval of screened disorders

1550 to 1750

Increase of ENBS screening Fee in March 19

True

T/F;

Philhealth covers full coverage of the ENBS in the newborn Care package which includes the coverage of the ENBS fee of 1750

50 pesos

ENBS shall have an allowable charge of __pesos for the collection of samples

1st offense - warning

2nd offense - 50,000 fine

Penalty of the overpricing of NBS under DOH AO 2008-0026-A