FINALS: NEWBORN SCREENING ACT OF 2004 Flashcards
(82 cards)
1
Q
RA NO?
A
Republic Act No. 9288
2
Q
•a simple procedure to find out if
a baby has a congenital metabolic
disorder that may lead to mental
retardation or even death if left
untreated
• It is now recognized as part of the
standard newborn care
A
newborn screening
3
Q
increased the screening panel of
disorders from six (6) to more than twenty-eight (28).
A
Expanded Newborn Screening (ENBS)
4
Q
Why Expanded Newborn Screening (ENBS) is important?
A
Most babies with metabolic disorders look “normal” at birth. By doing ENBS, 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.
5
Q
When is Expanded Newborn
Screening (ENBS) done?
A
immediately after 24 hours from birth
6
Q
Newborn Screening Facilities will offer NBS under two (2) options:
A
Basic
Expanded
7
Q
Basic
A
Six-Test Panel of Disorders
8
Q
Expanded
A
Newborn Screening Test
9
Q
BASIC
A
Congenital Hypothyroidism (CH) Congenital Adrenal Hyperplasia (CАН)
Galactosemia (GAL)
G6PD Deficiency (G6PDD) Phenylketonuria (PKU)
Maple Syrup Urine Disease (MSUD)
10
Q
EXPANDED
A
Current Panel of six (6) disorders +
Cystic Fibrosis
Biotinidase Disease
Organic Acid Disorders
Fatty Acid Oxidation Disorders
Amino Acid Disorders
Urea Cycle Disorder Hemoglobin Disorders
11
Q
How NBS done?
A
A few drops of blood are taken from the baby’s heel, blotted on a special
absorbent filter card. The blood is air-dried for 4 hours, and then sent to Newborn Screening Center (NSC).
12
Q
Who will collect the sample for ENBS?
A
physician, nurse, medical technologist or trained midwife
13
Q
Where is ENBS available?
A
hospitals, lying-ins, rural health units, health centers and some private clinics
14
Q
How much is ENBS?
A
Expanded newborn screening costs ₱1750 and is included in the Newborn Care Package (NCP) for PhilHealth members.
15
Q
What is Newborn Care Package?
A
is a PhilHealth benefit package for essential health services of the
newborn during the first few days of life. It covers essential newborn care,
expanded newborn screening, and hearing screening tests.
16
Q
What are the eligibility conditions for newborn to avail of the NCP?
Newborns are eligible for NCP if ALL of the following are met:
A
• Either of the parents are eligible to avail of the benefits,
• Born in accredited facilities that perform deliveries, such as hospitals
and birthing homes; and
• Services were availed of upon delivery.
17
Q
How can results be claimed? for ENBS?
A
Results can be claimed from the health facility where ENBS was availed.
Normal ENBS results are available by 7 - 14 working days from the time
samples are received at the NSC.
Positive ENBS results are relayed to the parents immediately by the health facility.
18
Q
When is NBS approved?
A
April 7, 2004
19
Q
Republic Act No. 9288
A
AN ACT PROMULGATING A COMPREHENSIVE POLICY AND A NATIONAL SYSTEM FOR ENSURING NEWBORN SCREENING
20
Q
How many sections?
A
19
21
Q
How many articles?
A
5
22
Q
Article 1
A
GENERAL PROVISIONS
23
Q
What sections are included in Article 1?
A
Sections 1-3
24
Q
Section 1
A
Short Title
25
Section 2
Declaration of Policy
26
Section 3
Objectives
27
This Act shall be known as the "Newborn Screening Act of 2004."
SECTION 1. Short Title
28
It is the policy of the State to protect and promote the right to health of the people, including the rights of children to survival and full and healthy development as normal individuals. 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 nongovernment agencies at the national and local levels, 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 and thus be spared from heritable conditions that can lead to mental retardation and death if undetected and untreated.
SEC. 2. Declaration of Policy
29
1) 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;
2) To establish and integrate a sustainable newborn screening system within the public health delivery system;
3) 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
4) 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.
SEC. 3. Objectives
30
ARTICLE 2:
DEFINITION OF TERMS
31
What section under in Article 2?
Section 4
32
Under this Act, the following terms shall have the meanings respectively given to them below:
SEC. 4. Definitions
33
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
34
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.
Follow-up
35
mean hospitals, health infirmaries, health centers, lying-in centers or puericulture centers with obstetrical and pediatric services, whether public or private.
Health institutions
36
means physicians, nurses, midwives, nursing aides and traditional birth attendants.
Healthcare practitioner
37
means 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 condition
38
NIH means the
National Institute of Health
39
means a child from the time of complete delivery to 30 days old.
Newborn
40
means 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
41
means 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
42
means 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
Newborn Screening Reference Center
43
means the various means of providing parents or legal guardians information about newborn screening.
Parent education
44
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.
Recall
45
means 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
46
ARTICLE 3:
NEWBORN SCREENING
47
What sections under Article 3?
Sections 5-9
48
SEC. 5.
Obligation to Inform
49
SEC. 6.
Performance of Newborn Screening
50
SEC. 7.
Refusal to be Tested
51
SEC. 8.
Continuing Education, Re-education and Training Health Personnel
52
SEC. 9.
Licensing and Accreditation
53
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. Appropriate notification and education regarding this obligation shall be the responsibility of the Department of Health (DOH).
SEC. 5. Obligation to Inform
54
Newborn screening shall be performed after twenty-four (24) hours of life but not later than three (3) days from complete delivery of the newborn. 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 seven (7) days of age. It shall be the joint responsibility of the parent(s) and the practitioner or other person delivering the newborn to ensure that newborn screening is performed. An appropriate informational brochure 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.
SEC. 6. Performance of Newborn Screening
55
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.
SEC. 7. Refusal to be Tested
56
The DOH, with the assistance of the NIH and other government agencies, professional societies and non-government organizations, shall: (i) conduct continuing information, education, re-education and training programs for health personnel on the rationale, benefits, procedures of newborn screening; and (ii) disseminate information materials on newborn screening at least annually to all health personnel involved in material and pediatric care.
SEC. 8. Continuing Education, Re-education and Training Health Personnel
57
- 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
SEC. 9. Licensing and Accreditation
58
ARTICLE 4 :
IMPLEMENTATION
59
What sections under Article 4?
Sections 10-16
60
SEC. 10.
Lead Agency
61
SEC. 11.
Advisory Committee on Newborn Screening
62
SEC. 12. .
Establishment and Accreditation of Newborn Screening Centers
63
SEC. 13. .
Establishment of a Newborn Screening Reference Center
64
SEC. 14. .
Quality Assurance
65
SEC. 15.
Database
66
SEC. 16. .
Newborn Screening Fees
67
. - The 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.
SEC. 10. Lead Agency
68
. - The 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.
SEC. 10. Lead Agency
69
. 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.
The Committee shall be composed of eight (8) members, including the Secretary of Health who shall act as Chairman. The other members of the Committee shall be as follows: (i) the Executive Director of the NIH, who shall act as Vice Chairperson; (ii) an Undersecretary of the DILG; (iii) the Executive Director of the Council for the Welfare of Children (iv) the Director of the Newborn Screening Reference Center; and (v) 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 three (3) representatives shall be appointed for a term of three (3) years, subject to their being reappointed for additional three (3) years period for each extension.
The Committee shall meet at least twice a year. The NIH shall serve as the Secretariat of the Committee.
SEC. 11. Advisory Committee on Newborn Screening
70
- 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. At a minimum, every Newborn Screening Center shall: (i) have a certified laboratory performing all tests included in the newborn screening program, (ii) have a recall/follow up programs for infants found positive for any and all of the heritable conditions; (iii) be supervised and staffed by trained personnel who have been duly qualified by the NIH; and (iv) submit to periodic announced or unannounced inspections by the Reference Center in order to evaluate and ensure quality Newborn Screening Center performance.
SEC. 12. Establishment and Accreditation of Newborn Screening Centers.
71
. - 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.
SEC. 13. Establishment of a Newborn Screening Reference Center
72
. - 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.
SEC. 14. Quality Assurance
73
. - 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. It shall submit reports annually to the Committee and to the DOH on the status of and relevant health information derived from the database. A plan for long-term outcome evaluation of newborn screening utilizing the cases registries shall be developed within one (1) year of passage of this Act by the NIH Newborn Screening Reference Center in consultation with the Advisory Committee on Newborn Screening. Implementation of this plan shall become a responsibility of the Advisory Committee on Newborn Screening.
SEC. 15. Database
74
. -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.
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 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 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.
SEC. 16. Newborn Screening Fees
75
ARTICLE 5:
FINAL PROVISIONS
76
What sections under Article 5?
Sections 17-19
77
SEC. 17.
Repealing Clause
78
SEC. 18.
Separability
79
SEC. 19.
Effectivity
80
. - All general and special laws, decrees, executive orders, proclamations and administrative regulations, or any parts thereof, which are inconsistent with this Act are hereby repealed or modified accordingly
SEC. 17. Repealing Clause
81
. - If, for any reason or reasons, any party of provisions of this Act shall be declared or held to be unconstitutional or invalid, other provision or provisions hereof which are not affected thereby shall continue to be in full force and effect.
SEC. 18. Separability
82
. - This Act shall take effect fifteen (15) days after its publication in at least two (2) newspapers of general circulation.
SEC. 19. Effectivity
