[ REPUBLIC ACT NO. 9288, April 07, 2004 ]

"Newborn Screening Act of

2004."

SECTION 1.

Declaration of Policy.

SEC. 2.

Objectives

SEC. 3.

(mental retardation, serious health complications or death) (sustainable newborn screening) (advantages) (promoting their child's right) (parenthood)

The objectives of the National Newborn Screening System are:

1) To ensure that every newborn has access to newborn screening for certain heritable

conditions that can result in (________________, _____________, ________) if left undetected and untreated.

2) To establish and integrate a (_____________) system within the public

health delivery system.

3) To ensure that all health practitioners are aware of the (__________) 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 (____________________) to health and full development, within the context of responsible (______________), by protecting their child from preventable causes of disability and death through newborn screening.

GENERAL PROVISIONS

ARTICLE 1

DEFINITION OF TERMS

ARTICLE 2

NEWBORN SCREENING

ARTICLE 3

IMPLEMENTATION

ARTICLE 4

FINAL PROVISIONS

ARTICLE 5

Definitions

SEC. 4

Comprehensive Newborn Screening System

means 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

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 or dietary

prescriptions

Health institutions

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

Healthcare practitioner

means physicians, nurses, midwives, nursing aides and

traditional birth attendants.

Heritable condition

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.

Newborn

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

Newborn Screening

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 Center

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 Reference Center

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 Committee on Newborn Screening.

Parent education

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

Recall

means a procedure for locating a newborn with a possible heritable condition for purposes of providing the newborn with appropriate laboratory testing to confirm the diagnosis and, as appropriate, provide treatment.

(Treatment) (treating)

(_____________)

means the provision of prompt, appropriate and adequate medicine, medical and surgical management or dietary prescription to a newborn for purposes of (____*optional to answer*____) or mitigating the adverse health consequences of the heritable condition.

Obligation to Inform.

SEC. 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 availability, nature and benefits of newborn screening. Appropriate notification and education regarding this obligation shall be the responsibility of the Department of Health (DOH).

Performance of Newborn Screening.

SEC. 6

Performance of Newborn Screening) (twenty-four (24) ( three (3) (3-day) seven (7) days

(___________________)

Newborn screening shall be performed after (_____________) hours of life but not later than (______________) 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 (_________) requirement but must be tested by (____________) 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.

Refusal to be Tested.

SEC. 7

Refusal to be Tested.

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

Continuing Education, Re-education and Training of Health Personnel.

SEC. 8.

Continuing Education, Re-education and Training of Health Personnel.

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 maternal and pediatric care.

Licensing and Accreditation

SEC. 9.

Licensing and Accreditation.

—The DOH and the Philippine Health Insurance

Corporation (PHIC) shall require health institutions to provide newborn screening services

as a condition for (__________/__________)

(Newborn Screening) (one hundred eighty (180) (Interior and Local Government (DILG) (testing protocols and quality assurance)

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 (____________);

2) Develop the implementing rules and regulations for the immediate implementation of a nationwide newborn screening program within (_______________) days from the enactment of this Act;

3) Coordinate with the Department of the (__________________) 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 (___________________) programs.

Advisory Committee on Newborn-Screening.

SEC. 11.

Advisory Committee on Newborn-Screening (Committee)

To ensure sustained inter-agency collaboration, the (_________________________) is hereby created and made an integral part of the Office of the Secretary of the DOH. The (__________) 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 Newborn 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 Chairperson. 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) year periods for each extension.

The Committee shall meet at least twice a year. The NIH shall serve as the Secretariat of

the Committee.

Establishment and Accreditation of Newborn Screening Centers.

SEC. 12.

Establishment and Accreditation of Newborn Screening Centers.

—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 of 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.

Establishment of a Newborn Screening Reference Center.

SEC. 13.

Establishment of a 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

Quality Assurance.

SEC. 14.

Quality Assurance.

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.

Database.

SEC. 15.

Database

(___________________)

—All Newborn Screening Centers shall coordinate with the NIH Newborn Screening Reference Center for consolidation of patient (1) (_____________). The NIH Newborn Screening Reference Center shall maintain a national (1) (_____________) of patients tested and a registry for each condition. It shall submit reports annually to the Committee and to the DOH on status of and relevant health information derived from the (1) (_____________). A plan for long-term outcome evaluation of newborn screening utilizing the cases registries shall be developed with in 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

Newborn Screening Fees.

SEC. 16.

Newborn Screening Fees.

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

(DOH's Centers for Health Development) (Newborn Screening Centers for human resource development) (NIH Newborn Screening Reference Center)

To ensure sustainability of the National System for Newborn Screening, the newborn sc reening fee shall be divided and set aside for the following purposes: at least four percent (4 %) to the (__________________________) 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 (________________________________) and equipment maintenance and upgrading; at least four percent (4%) to the (__________________) 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

Repealing Clause

SEC. 17.

—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.

Separability

SEC. 18.

—If, for any reason or reasons, any part 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.

Effectivity

SEC. 19

— This Act shall take effect fifteen (15) days after its publication in at least two (2) newspapers of general circulation

APR 7 2004

Approved: