RA 9288 (Newborn Screening Act of 2004) Flashcards
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 (NBS)
Why is the newborn screening important?
- 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.
Effects of organic acid disorders if is not screened:
● Developmental delay
● Breathing problems
● Neurologic damage
● Seizures
● Coma
● Early death
Effects of organic acid disorders if it is screened and managed:
● Alive
● Most will have normal development with episodes of metabolic crisis
Effects of endocrine disorder if not screened:
● Severe mental retardation
● Death
Effects of endocrine disorders if screened and managed:
● Normal
● Alive
Effects of fatty acid oxidation disorder if not screened:
● Developmental and physical delays
● Neurologic impairment
● Sudden death
● Coma
● Seizure
● Enlargement of the heart & liver
● Muscle weakness
Effects of fatty acid oxidation disorder if screened and managed:
● Usually healthy in between episodes metabolic crises
● Alive
Effects of hemoglobinopathies if not screened:
● Painful crises
● Anemia
● Stroke
● Multi-organ failure
● Death
Effects of hemoglobinopathies if screened and managed:
● Alive
● Reduces the frequency of painful crises
● May reduce the need for blood transfusions
Effects of urea cycle defect if not screened:
● Seizure
● Mental retardation
● Death
Effects of urea cycle defect if screened and managed:
● Alive
● Normal intelligence
Effect of amino acid disorders if not screened:
● Mental retardation
● Coma and death from metabolic crisis
Effects of amino acid disorders if screened and managed:
● Alive
● Normal growth
● Normal intelligence for some, learning problems to others
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. 9288 otherwise known as Newborn Screening Act of 2004.
NBS Program
What agency acts as the 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?
Department of Health (DOH)
Newborn screening program in the Philippines currently includes screening of six disorders:
- Congenital hypothyroidism (CH)
- Congenital adrenal hyperplasia (CAH)
- Phenylketonuria (PKU)
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Galactosemia (GAL)
- Maple syrup urine disease (MSUD)
When should the newborn screening usually done?
After 24 hours from birth
How is the newborn screening 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).
Who will collect the sample?
● Physician (4)
● Nurse (2)
● Medical technologist (1)
● Trained midwife (3)
National Policy and Strategic Framework on Expanded Newborn Screening for 2017-2030
Administrative Order No. 2018-0025
The Guidelines on the Implementation of the Expanded Newborn Screening Program
Administrative Order No. 2014-0045
Enumerate the six operational NSCs in the country:
- NIH at the University of the Philippines Manila Confirmatory tests are done at newborn screening reference centers (UPM NIH).
- Visayas - West Visayas State University Medical Center, Iloilo City
- Mindanao - Southern Philippines Medical Center, Davao City
- Central Luzon - Angeles University Foundation Medical Center
- Southern Luzon - Mariano Marcos Memorial Hospital and Medical Center, Tanauan City, Batangas
- Northern Luzon - Daniel Mercado Medical Center, Batac City, Ilocos Norte
What is the Section 1 of RA 9288?
Title: “Newborn Screening Act of 2004”
What is the Section 2 of RA 9288?
Declaration of Policy
Identify what section:
In pursuit of such policy, 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 at the national and local levels, the private sector, families and communities, professional health organizations, academic institutions, and non-governmental organizations.
Section 2: Declaration of Policy
Identify what Section:
The National Newborn Screening System 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.
Section 2: Declaration of Policy
What is the Section 3 of RA 9288?
Objectives
What are the objectives in Section 3?
a. 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
b. To establish and integrate a sustainable newborn screening system within the public health delivery system
c. 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
d. 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
What is the Section 4 of RA 9288?
Definitions
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.
Comprehensive Newborn Screening System
It defines 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.
Follow-up
Hospitals, health infirmaries, health centers, lying-in centers or puericulture centers with obstetrical and pediatric services, whether public or private.
Health institutions
Who are the healthcare practitioners involved in RA 9288?
- physicians
- nurses
- midwives
- nursing aides
- traditional birth attendants
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.
Heritable conditions
What is the meaning of NIH?
National Institute of Health
A child from the time of complete delivery to 30 days old.
Newborn
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
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 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 and acts as the Secretariat of the Advisory Committee on Newborn Screening.
Newborn Screening Reference Center
The various means of providing parents or legal guardians information about newborn screening.
Parent education
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.
Recall
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.
Treatment
What is the Section 5 of RA 9288?
Obligation to Inform
Identify 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.
Section 5: Obligation to Inform
What is the Section 6 of RA 9288?
Performance of Newborn Screening
The performance of newborn screening shall be performed after __________ hours of life but not less than ___ days from complete delivery of the newborn.
24 hours; not less than 3 days
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 of age.
7
True or False
As stated in Section 6, joint responsibility of the parent(s) and the practitioner or other person delivering the newborn to ensure that newborn screening is performed.
True
What is the Section 7 of RA 9288?
Refusal to be Tested
Identify 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.
Section 7: Refusal to be Tested
What is the Section 8 of RA 9288?
Continuing Education, Re-education, and Training Health Personnel
The DOH, with the assistance of the NIH and other government agencies, professional societies and non-government organizations, shall:
- Conduct continuing information, education, re-education, and training programs for health personnel on the rationale, benefits, procedures of newborn screening
- Disseminate information materials on newborn screening at least annually to all health personnel involved in material and pediatric care.
What is the Section 9 of RA 9288?
Licensing and Accreditation
Identify what Section:
The DOH and the Philippine Health Insurance Corporation shall require health institutions to provide newborn screening services as a condition for licensure or accreditation.
Section 9 - Licensing and Accreditation
What is the Section 10 of RA 9288?
Lead Agency
Section 10: Lead Agency
Functions of DOH as the lead agency:
- 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.
What is the Section 11 of RA 9288?
Advisory Committee on Newborn Screening
What are the functions of the Advisory Committee on Newborn Screening?
- 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
- recommend corrective measures as deemed necessary
How many members are composed in the Advisory Committee on Newborn Screening?
8
Who are the members of the committee in newborn screening?
- Chairman – Secretary of Health
- Vice Chairperson – Executive Director of the NIH
- 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.
The committee shall meet at least ____ a year.
Twice
Terms of three representatives in the committee:
- Appointed for a term of three (3) years
- Subject to their being reappointed for additional three (3) years period for each extension.
What is the Section 12 of RA 9288?
Establishment and Accreditation of Newborn Screening Centers
Identify 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.
Section 12: Establishment and Accreditation of Newborn Screening Centers
In Section 12, the 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
- Submit to periodic announced or unannounced inspections by the Reference Center in order to evaluate and ensure quality Newborn Screening Center performance
What is the Section 13 of RA 9288?
Establishment of a Newborn Screening Reference Center
The NIH shall establish a Newborn Screening Reference Center shall be responsible for:
Section 13 - Establishment of a Newborn Screening Reference Center
- national testing database and case
- registries
- training
- technical assistance
- continuing education for laboratory staff in all Newborn Screening Centers
What is the Section 14 of RA 9288?
Quality Assurance
The NIH Newborn Screening Reference Center shall be responsible for:
Section 14 - Quality Assurance
- Drafting and ensuring good laboratory practice standards for newborn screening centers
- Act as the principal repository of technical information relating to newborn screening standards and practices
- Provide technical assistance to newborn screening centers
What is the Section 15 of RA 9288?
Database
Identify the Section:
- NIH Newborn Screening Reference Center shall maintain a national database of patients tested and a registry for each condition
- Submit reports annually to the Committee and to the DOH on the status of and relevant health information derived from the database
- Plan for long-term outcome evaluation of newborn screening
Section 15: Database
What is the Section 16 of RA 9288?
Newborn Screening Fees
The newborn screening fee of the DOH’s Center for Health Development should have at least and solely for?
4%
Purpose:
- Follow-up services
- Education
- Provision of newborn screening services
The newborn screening fee of the Newborn Screening Centers should have at least and solely for?
4%
Purpose:
- human resource development
- equipment maintenance and upgrading
The newborn screening fee of the NIH Screening Reference Center should have at least and solely for?
4%
Purpose:
- Overall supervision
- Training and continuing education
- Maintenance of national database
- Quality assurance program
- Monitoring of the national program
Who serves as the Secretariat in the members of the Advisory Committee on Newborn Screening?
NIH
National Institute of Health
When was RA 9288 approved?
April 7, 2004
The Proclamation No. ___ states that every first week of October of each year as “National Newborn Screening Week”.
Proclamation No. 540
How many sections are there in RA 9288?
19 sections
Significance of this Act
To reduce preventable deaths of all Filipino newborns due to more common and rare congenital disorders through timely screening and proper management
Specimen collected in newborn screening
Blood from heel of newborn
Who was the President of the Philippines during the approval of RA 9288?
Gloria Macapagal-Arroyo
Who is the chairman in the Advisory Committee on Newborn Screening?
DOH secretary
Teodoro Herbosa
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When was the expanded newborn screening program implemented?
2014
What should be submitted if parent or legal guardian refuses testing?
Consent form/letter to acknowledge
Center responsible for the national testing database and case registries, training, and technical assistance for NBS is the ____.
Newborn Screening Reference Center
Who are the institutions that require health institutions to provide newborn screening services as a condition for licensure or accreditation?
DOH & Philippine Health Insurance Corporation
When is the earliest time to do Newborn Screening?
24 hours after birth
Newborn on Intensive Care Unit may be screening until __ days after birth
7 days
When was Proclamation No. 540 established?
January 20, 2004
