November 19, 2014
ADMINISTRATIVE ORDER
No. 2014 – 0045
GUIDELINES ON THE IMPLEMENTATION OF THE EXPANDED
NEWBORN SCREENING PROGRAM
I. RATIONALE
Efforts are continuously
being done to achieve the goal of saving Filipino newborns for common life–threatening
heritable disorders. To this end, the National Comprehensive Newborn Screening
System is expanding the screening panel of disorders from six (6) to more than
twenty (20) disorders. And expanded screening program will give opportunities
to significantly improve the quality of life for affected newborn and will also
identify babies whose conditions may not become symptomatic until permanent
damage or disability has occurred.
Review data on Filipino
newborns screened in the California newborn screening program from 2005 to
2011, showed that Filipino newborns confirmed positive with several disorders
in the newborn screening panel. The disorders were a mix of endocrinologic and
metabolic conditions as well as hemoglobinopathies (Padilla, 2012).
The data prompted a review
and subsequently a formal recommendation of the expanded newborn screening
program in the Philippines to the Advisory Committee on Newborn Screening.
In line with the
implementation of the expanded newborn screening, a National Technical Working
Group (NTWG) was created under the National Center for Disease Prevention and
Control (NCDPC) composed of representatives of key offices at the Department of
Health and of different concerned institutions. The NTWG was tasked to prepare
the necessary guidelines for the implementation of expanded newborn screening
in the country.
II. OBJECTIVE
This Administrative Order
sets the guidelines for the implementation of the expanded newborn screening in
the country.
III. SCOPE AND
COVERAGE
Provisions of this
Administrative Order shall apply to all Newborn Screening Centers, DOH –
Regional Offices, DOH – ARMM, National Comprehensive Newborn Screening System –
Treatment Network, health facilities and all other agencies and stakeholders
concerned in the implementation of the newborn screening program.
IV. DEFINITIONS OF
TERMS
1. Confirmatory Center refers to a facility
identified by the DOH to be part of the National Comprehensive Newborn
Screening System Treatment Network. It is equipped to do confirmatory testing
to ensure the accuracy of screening results.
2. Newborn Screening Continuity Clinic refers to an
ambulatory clinic based in a tertiary hospital identified by the DOH to be part
of the National Comprehensive Newborn Screening System Treatment Network. It is
equipped to facilitate continuity of care of confirmed patients in its area of
coverage.
3. National Comprehensive Newborn Screening System
Treatment Network refers to a network wherein total management of
patient with confirmed diagnosis shall be referred to. It follows the DOH–approved
clinical protocol in the management of patients diagnosed in any of the
disorders included in the newborn screening panel.
4. Newborn Screening Center (NSC) refers to a
facility equipped with a newborn screening laboratory that complies with the
standards established by the National Institute of Health, and provides all
required laboratory tests and recall/follow–up programs for newborns with
heritable conditions.
5. Newborn Screening Reference Center (NSRC) refers to the
central facility at the National Institute of Health that defines testing and
follow–up protocols, maintains an external laboratory proficiency testing
program, oversees the national testing database and case registries, assists in
the 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.
6. Republic Act 9288: Newborn Screening Act of
2004 refers to the act promulgating a comprehensive policy and a national
system for ensuring newborn screening.
V. GENERAL
GUIDELINES
1. The number of disorders in the newborn screening
panel shall be increased from six (6) to twenty eight (28) falling under
various types of disorders namely: hemoglobinopathies, amino acid disorders,
organic acidurias, disorders of fatty acid oxidation, disorders of carbohydrate
metabolism, and disorders of biotin metabolism, cystic fibrosis and endocrine
disorders.
2. Site renovations / preparations, procurement of
equipment and reagents, hiring and training of personnel, upgrading of
database, preparation of manuals and protocols, and implementation of other
necessary program groundwork shall be undertaken prior to the implementation of
the expanded newborn screening.
3. The necessary confirmatory centers and network for
referral, management and treatment of patients found positive under the
expanded newborn screening shall likewise be established in strategic areas of
the country.
4. Pilot–run of the Expanded Newborn Screening shall be
undertaken at the Newborn Screening Center – National Institute of Health, prior
to full implementation before 2015.
5. Newborn screening shall be offered in all
participating facilities with two options:
a. Option 1; six (6) disorders (CH, CAH, GAL, PKU, G6PD
and MSUD) under the basic NBS panel; and
b. Option 2: twenty eight (28) disorders under the
expanded newborn screening panel
6. Confirmatory centers for the additional disorders
shall be identified.
7. A network of specialists shall be identified for the
management of the additional disorders.
8. A separate policy shall be issued in the
identification of expert panel.
9. Newborn Screening Continuity Clinics shall be set–up
to facilitate long term care of patients confirmed through newborn screening.
10. Information on the expanded screening and the disorder
included shall be made available to health professionals, parents, and the
general public at all NSCs, DOH – Regional offices and Newborn Screening
Facilities.
VI. SPECIFIC
GUIDELINES / IMPLEMENTING MECHANISM
In terms of the different
components of the newborn screening program, the following shall be considered
in the implementation of the expanded screening:
A. Procedure
1. Implementing expanded newborn screening shall
involve a series of steps from motivation, screening, follow–up, diagnosis, management
and evaluation.
2. As stated in Section 6 of the implementing rules and
regulation of R.A. 9288, an health practitioner who delivers, or assists in the
delivery of a newborn in the Philippines shall, prior to delivery, inform
parents of legal guardian of the newborn of the availability, nature and
benefits of NBS. Health practitioners shall follow the DOH prescribed
guidelines on notification and education relative to the obligation to inform.
The DOH, other government agencies, non– government agencies, professional
societies and LGUs shall make available appropriate information materials and
shall have a system of its distribution. The health practitioner shall maintain
documentation in the patient’s records that NBS information has been provided.
3. Refusal Form shall be accomplished by parents
refusing newborn screening.
4. The same screening protocol, which includes the
proper timing and specimen collection, transport, laboratory testing, and
reporting in compliance with the implementing rules and regulation of Republic
Act 9288 shall be followed.
B. Reporting and Monitoring Protocols
An evaluation plan shall be
implemented that would clearly define selected indicators, assign
responsibility for monitoring, and outline the periodicity with which
evaluations are to occur. The program evaluation shall encompass the detailed
procedures, operational arrangement and budget source.
C. Roles and Responsibilities
To ensure implementation of
expanded NBS, the agencies/organization identified below shall have the
following responsibilities:
1. The Department of Health
a. The FHO shall be the lead agency in the
implementation of expanded newborn screening. Its roles and responsibilities
are stated in Section13 of the implementing rules and regulations of R.A. 9288.
b. The FHO, as the lead in the National Technical
Working Group (NTWG) on Newborn Screening shall ensure that the expanded
screening is integrated into the NTWG’s various functions of long–term or
medium–term target setting and planning. This shall ensure that all policies,
guidelines and standards of the expanded screening program adhere to overall
internationally accepted standards and ethical considerations. Specifically,
expanded screening shall be included in the NTWG’s functions of:
(1) Developing /
reviewing policies, standards and guidelines on Newborn Screening for
recommendations to and approval of the Advisory Committee on the Newborn
Screening Program;
(2) Recommending the
disorders to be included in the Newborn Screening panel;
(3) Reviewing and
recommending the Newborn Screening fee to be charged by the Newborn Screening
Centers;
(4) Developing
/reviewing strategies and tools that ensure effective and efficient
implementation of the Newborn Screening at various levels;
(5) Formulating
national program/project plan, proposals and collaborative studies on Newborn
Screening; and
(6) Reviewing the
report of the Newborn Screening Centers and recommended corrective measures as
deemed necessary.
c. The Health Promotion and Communication Service
(HPCS), in coordination with the NSRC, shall be responsible for advocacy and
information dissemination on expanded screening to the communities throughout
the country prior to and during the implementation of expanded screening.
2. Health Facilities
Health facilities, i.e.
hospitals, birthing facilities, rural health units and health centers, shall
ensure that the expanded newborn screening is offered as an option. It shall be
integrated in their Newborn Screening Services and provision of information,
education, communication, screening, recall and management of identified cases
and other related services, as outlines in Section 14 of the IRR of R.A. 9288,
shall be undertaken.
3. Newborn Screening Reference Center
NSRC shall define the
testing and follow–up protocols for the additional disorders; maintains and
external laboratory proficiency testing program, and integrating the additional
disorders in its case registries and national testing database it oversees;
assists in training activities in all aspects of the NBS program.
4. Newborn Screening Centers
NSCs shall ensure that
laboratory space, equipment and supplies needed for the implementation of the
expanded newborn screening are in place. It shall ensure that the mechanism for
ordering and payment of expanded newborn screening service is in place. It
shall ensure that patients identified positive in any of the disorders are
followed up and referred to specialists for initial management. All NSCs shall
strictly follow the prescribed guidelines of good laboratory practices.
5. Newborn Screening Continuity Clinics
Newborn Screening Continuity
Clinics shall facilitate continuous care of confirmed positive patients. It
shall provide long–term follow–up care activities related to improving care
delivery, including engagement of affected individuals and their families.
D. Budget Source
1. The NBS Fee
a. The cost of the tests shall be as follows (per
recommendation of the Advisory Committee on Newborn Screening on August 19,
2012):
Option 1 (6 disorders) – Php
550.00
Option 2 (expanded newborn
screening) – Php 1,500.00.
b. For PhilHealth members, P550 shall be covered by
PhilHealth.
For Option 1 (6 disorders),
the total cost shall be covered
For Option 2 (expanded NBS),
only P550 shall be covered by PhilHealth and the balance shall be an out–of–pocket
expense of the family.
c. Both options 1 and 2 shall have an allowable charge
of P50 for the collection of the sample (DOH A.O. No. 2005 – 0005).
d. Overpricing of newborn screening fess shall be
reported to the Department of Health. The following administrative fines shall
be imposed on health facilities that were found liable for collecting more than
the maximum allowable NBS fees (DOH A.O. 2008 – 0026 – A):
First offense – warning
Second offense –
Administrative fine of fifty thousand pesos (P50,000)
Third offense –
administrative fine of one hundred thousand pesos (P100,000)
2. Usage of the NBS Fee
As stated in Section 22 of
the implementing rules and regulation of R.A. 9288, the NBS shall be applied
to, among others, testing costs, education, sample transport, follow up and
reasonable overhead expenses.
VII. REPEALING CLAUSE
Provisions of A.O. No. 121
series 2003 and all other issuances that are inconsistent with the provisions
of this Order are hereby repealed /rescinded.
VIII. SEPARABILITY
If any provision of this
Order is declared invalid, the other provision not affected thereby shall
remain valid and subsisting.
IX. EFFECTIVITY
This Order shall take effect
fifteen (15) days after its approval and publication in the Official Gazette or
newspaper of general circulation.
ENRIQUE T. ONA, MD
Secretary of Health
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