Administrative Order No. 2018 – 0025

NATIONAL POLICY AND STRATEGIC FRAMEWORK ON EXPANDED NEWBORN SCREENING FOR 2017 – 2030

 

I.     BACKGROUND

For two decades, the Newborn Screening (NBS) Program has successfully laid its foundation by integrating the program to the existing health system and infrastructure as outlines in the NBS strategic framework. Workshops for strategic planning on NBS were conducted in 2001 and 2009, respectively. Initially, the focus was on building the foundation for the NBS program and how it will be implemented in major facilities. Later, the program aimed to increase the national coverage by continuous implementation of NBS to the rest of the facilities nationwide and integration to the service delivery network through policies and advocacies.

Today, the National Comprehensive Newborn Screening System (NCNBSS) thrust in the next thirteen years is to ensure the sustainability of (NCNBSS), including the full shift to expanded newborn screening and the provision of continuing care for confirmed patients for any of the screened disorders. Several policies were released in 2014 in pursuit of these thrusts such as Administrative OrderNo. 2014 – 0045, which set the guidelines on the implementation of the Expanded Newborn Screening (ENBS) program and provided the option for parents to avail between the 6–test and ENBS test; and the DOH Administrative Order 2014 – 0035 that facilitated the initial establishment of the NBS Continuity Clinics in 14 regions to facilitate continuity of care of confirmed patients in their area of coverage.

The Department of Health (DOH) in coordination with its program partners reconfigured the NCNBSS framework for 2017 – 2030 to provide direction and to intensify the implementation, especially the ENBS. The plan shall concretize the long–term goals of NCNBSS.

 

II.    OBJECTIVES

This order aims to:

1. Provide a strategic framework for the implementation of the Expanded Newborn Screening Program from 2017 – 2030; and

2. Provide policy direction and guidance for DOH offices, its attached agencies, LGUs, and development partners in prioritizing interventions for the health of newborns.

 

III.  COVERAGE

This Order shall apply to the entire public and private health system, including DOH bureaus, Regional Offices (ROs), hospitals and other health facilities, attached agencies, local government facilities, external development partners and other stakeholders implementing health programs for and with pregnant women, mothers, and newborns.

 

IV.   DEFINITION OF TERMS

1. Newborn Screening is an essential public health strategy that enables the early detection and management of several congenital disorders (metabolic and endocrine disorders, hemoglobinopathies, and cystic fibrosis), which if left untreated, may lead to mental retardation, disability and/or death.

2. Long term management system is the provision of appropriate management, intervention, and support services to all confirmed cases of NBS disorders to enable optimal, physical, mental, and social outcomes for these individuals.

 

V.    GENERAL GUIDELINES

1. The National Policy and Strategic Framework on Expanded Newborn Screening for 2017 – 2030 shall guide healthcare interventions on newborn screening to be able to attain the following targets by 2030:

a. At least 95% national coverage of the expanded newborn screening.

b. At least 90% of health facilities with maternity and newborn services that includes expanded newborn screening.

c. At least 95% monitoring data are generated from regional offices and Newborn Screening Facilities (NSFs) through online monitoring system.

d. 100% ISO certification of all newborn screening centers and newborn screening reference center;

e. 100% of comprehensively trained and certified personnel who will perform NBS collection in NSFs.

f.  At least 95% of regions maintained 99% satisfactory sample collection rate.

g. 100% PHIC coverage of the newborn care package to include ENBS.

h. At least 85% of identified strategically located provinces with established long–term management system for NBS confirmed positive patients.

 

2. STRATEGIC FRAMEWORK

The Newborn Screening Program is guided by the following principles: (a) integration with all child health programs; (b) evidence–based interventions/approach, quality; and (c) sustainability and partnership and shared responsibilities. The Strategic Framework for Newborn Screening directs the program for the next 13 years and is aimed to ensure the sustainability and nationwide implementation of expanded newborn screening program through actionable program components and variety of strategies (See Annex A).

The shift from the six–panel screening into an expanded screening for 28+ panel of heritable disorders would entail upgrading, strengthening, and sustaining the different program components with the result of delivery of quality of services through ISO certified facilities and reaching out to every infant in the community. The service is not limited to screening alone but long–term management of children who are confirmed positive for congenital disorders.

3. The targets are to be achieved through the following strategies:

STRATEGIES

(1) Ensuring Efficient Operations, Systems, and Network Management

This shall be upgraded to reach areas that need access to newborn care. This includes construction and/or renovation of well–planned and equipped infrastructures to ensure quality service among patients and to engage more health facilities to offer NBS services (human resource for health–trained and capacitated).

a. Development of Manual of Operation and Standards from screening, confirmatory testing to referral and management.

b. ISO 15189:2012 Certification of all Newborn Screening Centers (NSCs).

c. Information dissemination geared towards importance and regulation of testing in confirmatory centers.

(2) Expanding Package of Services and Delivery Network

In the next ten years, the program aims to shift fully into expanded newborn screening. Enrolment of new facilities and sustaining the operations of existing facilities is critical in increasing the coverage of service delivery. Strategic actions to increase the uptake of ENBS are critical to ensure nationwide implementation, which involves strong promotion, advocacy, and cooperation of the newborn screening facilities.

a. Opening of additional three NSCs shall ensure expedient sending and receiving of results to and form geographically isolated and disadvantaged facilities.

b. Setting up continuity clinics and referral system in the provinces to further strengthen the referral and management network of positive cases in the hope that no patient will be deprived of long–term care.

c. Strict enforcement of newborn screening policies to ensure delivery of sustainable ENBS service at the national level down to local level.

d. Enhancement of diagnosis, follow up, and management of confirmed cases through prompt recall and confirmatory tests of patients by effective utilization of patients, collaborative partnerships and assessment of recall and follow-up protocols.

e. Training and deployment of clinical geneticists, pediatric endocrinologist, and genetic counsellors at the provincial level.

f.  Develop human resource complement positions at the DOH and Local Government Units (LGUs) to ensure that nurses, doctors, and other health professionals working in the continuity clinics and regional offices are given plantilla positions.

(3) Enhancing Health Promotion and Advocacy

This requires a developed and well–coordinated comprehensive health promotion and communication plan targeting different audiences to increase awareness and uptake on expanded newborn screening. It shall also focus on information campaign by strengthening communication strategies using different medial platforms.

a. Develop an ENBS national communications plan to increase the uptake of ENBS nationwide.

b. Strengthen alliance building with different organizations and Local Government Units (LGUs).

c. Integrate ENBS in the academic curriculum with other health related subjects in the secondary and tertiary levels, specifically in Grade 8 level.

d. Intensify training and development of innovative training materials for newborn screening with post training evaluations.

(4) Optimizing Health Information Management Systems for Expanded Newborn Screening

This aims to optimize current investments on health management information systems by adopting interoperable, consensus–based, evidence–driven and standards–based vocabularies and system that maximize the use of electronic health record systems that will automatically process and send information and reports to (a) Philhealth for verification of claims for NBS, and (b) the NBS registry for program planning and research purposes, among others.

a. Establish efficient national database and case registries for real–time generation of data.

b. Develop and implement online monitoring system for easy access of data.

(5)   Strengthen Monitoring and Evaluation

Program monitoring and evaluation of procedures and systems, both for laboratory and administrative units shall be undertaken to ensure smooth implementation of the program. Periodic review of monitoring and evaluation tools should be done including quality assurance assessment.

a. Modify NBS evaluation tools such as the Philippine Performance Evaluation Assessment System (PPEAS) tools for NSCs, ROs, Continuity Clinics and NSFs for periodic assessment.

b. Conduct program review, audit and evaluation procedures and systems for both laboratory and administrative units.

c. Establish local QA laboratory for the monitoring and evaluation of Newborn Screening Centers (NSCs).

(6) Establishing Sustainable Financing Scheme

The DOH, as the lead agency of the NBS program shall allocate funds for the set–up of new strategically–located newborn screening centers. The National Comprehensive Newborn Screening System (NCNBSS) also ensures funding for research relevant to the implementation of newborn screening at the national level that maybe utilized for policy recommendations. The Philippine Health Insurance Corporation (PHIC) also ensures full coverage of expanded newborn screening, while LGUs and other stakeholders and partners are empowered to provide ways or means to make the NBS accessible and affordable, particularly on the economically depressed areas.

a. Include full coverage of ENBS in the PhilHealth nerwborn care package.

b. Provide funds for research grants for policy recommendations on NBS.

c. Building alliance with LGUs and other institutions/agencies to allot budget for screening, confirmatory tests, and management in the continuity clinics by having a community financing schemes and programs.

d. Continuous collaboration to include NBS program in the Department of Health investment plan and allot budget for the needs of newborn screening from the national fund including health promotion and communication campaign at all levels using different media platforms.

 

VI.  Implementing Mechanisms

The DOH Central office shall act as the lead agency, along with the LGUs, for the implementation of this Order. The Advisory Committee on Newborn Screening (ACNBS) is the inter–agency body that reviews and recommends policies and standards to the Secretary of Health. The DOH created a Technical Working Group on Expanded Newborn Screening whose primary role is to oversee the implementation of the Program and monitor progress based on the M&E Framework. (see Annex B)

The following summarizes the roles and functions of the different group of stakeholders that have critical roles in the Newborn Screening Framework 2017 – 2030:

a.     DOH – Disease Prevention and Control Bureau shall undertake the following tasks:

·  Disseminate the strategic framework and enabling policies to ensure implementation of the strategies.

·  Mobilize funds and various resources of various offices and agencies for the set–up of strategically located new newborn screening centers, confirmatory centers, and continuity clinics all over the country.

·  Provide human resource complement through the provision of plantilla positions for nurses, doctors, and other health professionals to assure availability of dedicated and committed staff.

·  Provide technical and inputs/assistance in developing a health promotion and communication plan & materials for ENBS in collaboration with HPCS and NIH – NSRC to educate health professionals and the public.

·  Oversee the conduct of regular monitoring and evaluation of the program implementation. 

b.  DOH – Health Facilities and Services Regulatory Bureay (HFSRB)

·  Include certification from NSRC as part of licensing requirements for hospitals and birthing facilities.

·  Include NBS in their monitoring compliance in giving license to operate to hospitals and birthing facilities.

c. DOH – Health Human Resource Development Bureau (HHRDB)

Provision of human resource complement through the provision of plantilla positions for nurses, doctors, and other health professionals to assure availability of dedicated and committed staff is beyond the DOH capacity.

·  Develop competency–based modules on NBS for health service providers.

·  Man potential partner institutions to deliver NBS courses per region and per province.

·  Monitor the learning and development of NBS providers in coordination with the Regional Office Program Coordinators and Training Specialists.

d. DOH – Health Promotion and Communication Service (HPCS) shall develop comprehensive Newborn Screening health promotion and communications plan including prototype information, education & communication (IEC) materials and collaterals in coordination with DPCB – FHO and NIH – NSRC to facilitate advocacy for expanded newborn screening.

e. DOH – Knowledge Management Information Technology Service (KMITS) shall provide technical assistance in the (a) development, integration and maintenance of interoperable, consensus–based, evidence –driven and standards–based vocabularies and system module on NBS in electronic health record system; (b) development and maintenance of an NBS registry; and (c) facilitate and ensure interoperability of these HER systems with the NBS registry and other relevant information systems to facilitate knowledge management and timely decision-making.

f. DOH Regional Offices and DOH ARMM are the implementing arm of the Department of Health in the regional level and ARMM, where each has a designated Newborn Screening (NBS) Coordinator to facilitate and collaborate the full implementation of the program by the participating health units at the local level. The coordinators should be responsible of the following tasks:

·  Disseminate the strategic plan and enabling policies to LGUs and agencies in the regions.

·  Lead in the conduct of comprehensive training and orientations to hospitals, health organizations and the community.

·  Assist in all health information and advocacy activities, particularly in the promotion of ENBS.

·  Monitor and assist the recall of patients for immediate tracking and retrieval of positive screening for confirmatory testing, referral, and proper management.

g. Department of Interior and Local Government (DILG) in Regional Offices and ARMM

·  Encourage LGUs to implement R.A. 9288 and extend total cooperation in the implementation of the said law.

·  Assist DOH in the monitoring and evaluation of the program implementation.

h. Local Government Units (LGUs) of regions and ARMM

·  Develop the capabilities of health workers.

·  Issue local ordinances and resolutions that integrate NBS in the delivery of health delivery system.

·  Ensure that adequate and sustained NBS services such as information, education, communication, screening, recall and follow–up are being provided in all LGU health facilities (Rural Health Unit/City Health Unit, Lying–Ins, City/Municipal/District/Provincial Hospitals).

·  Establish a functional case management referral system with strategically accessible NCNBSS treatment network.

·  Establish coordination and networking among concerned agencies in NBS implementation.

·  Monitor and evaluate the newborn screening implementation in their localities.

·  Explore/encourage creative financially packages to make NBS accessible particularly among the poor populace.

·  Perform other roles and responsibilities as deemed necessary for the implementation of this Act.

i.  Philippine Health Insurance Corporation (PhilHealth)

·  Include proof of newborn screening services in their checklist for the accreditation of health facilities for quality newborn and pediatric services.

·  Facilitate increase of benefit package for newborns, covering the expanded newborn screening services.

j.  Department of Education (DepEd) and Commission on Higher Education (CHED) shall assist the DOH on the integration of newborn screening policy in the curriculum to be implemented by the school and higher education institutions at basic, secondary, and tertiary levels.

k. Newborn Screening Reference Center (NSRC) is the central facility that provides technical assistance to the Department of Health. It shall do the following:

·  Provide technical assistance in setting up NSCs including and capability building.

·  Define testing and follow–up protocols.

·  Maintain an External Laboratory Proficiency Testing Program.

·  Advocate and disseminate importance of taking confirmatory tests through creation and distribution of IEC materials.

·  Allocate funds for the fellowships to ensure the availability of qualified health personnel (e.g., Clinical Geneticists and Pediatric Endocrinologists) who could be tapped by the NCNBSS in the follow up treatment and monitoring for prompt and proper management of newborn babies screened positive.

·  Develop IEC materials and training modules among others, for dissemination to partners and facilities, for ENBS promotions.

·  Oversee the national testing database, case registries and content of educational materials.

·  Create a plan for long–term outcome evaluation of NBS utilizing the case registries.

·  Conduct regular monitoring and evaluation of the program.

·  Assist in the national training activities of the program.

·  Process the transfer of funds to the regional offices.

l.  Newborn Screening Centers are the facilities equipped with a newborn screening laboratory that comply with the standards established by the National Institutes of Health (NIH) and are responsible to the following tasks:

·  Create capability building plan and activities.

·  Provide financial support to continuity clinics.

·  Conduct all required tests for all newborn screening samples received.

·  Coordinate immediate recall or short term follow up of newborns with heritable conditions to sending NSFs and DOH Ros and DOH ARMM.

·  Participate in the follow up programs of newborns screening.

m.   Newborn Screening Host Facility lodged in health facilities shall provide for the venue or space for newborn screening centers.

n. Newborn Screening Facility implements the NCNBSS at the community level, which are responsible for the following tasks:

·  Integrate NBS in its delivery of health services specifically maternal and newborn services.

·  Serve as collecting health facility for NBS.

·  Coordinate with the duly accredited NSC covering their area.

·  Ensure that adequate and sustained NBS services such as information, education, communication, screening, recall and management of identified cases are being provided in the hospital.

·  Establish a NBS Team that will be responsible for the following: collection of samples, sending of samples to accredited NSC, prompt recall of positive patients, referral and management of patients.

·  Establish an appropriate financial system that will ensure effective and efficient collection of fees and payment of NBS services to the NSC.

·  Conduct orientation and/or training of hospital staff on NBS.

·  Define creative financial packages to make NBS accessible particularly among the poor populace.

 

VII. REPEALING CLAUSE

The provisions of previous Orders and other related issuances inconsistent or contrary with the provisions of this Administrative Order, including A.O. No. 2014 – 0045 are hereby revised, modified, repealed or rescinded accordingly. All other provisions existing issuances which are not affected by this Order shall remain valid and in effect.

 

VIII.  SEPARABILITY CLAUSE

If any provision of this Order is declared unauthorized or rendered invalid by any court of law or competent authority, those provisions not affected thereby shall remain valid and effective.

 

IX.   EFFECTIVITY

This Order shall take effect immediately.

FRANCISCO T. DUQUE III, MD, MSc

Secretary of Health

ANNEX A: STRATEGIC FRAMEWORK

Overall Mission	The National Comprehensive Newborn Screening System shares the vision of the Child 2025 Planning Framework aiming every Filipino child will be (1) Born healthy and well, with an inherent right to life, endowed with human dignity and (2) reaching her/his full potential with the right opportunities and accessible resources.
	To ensure that all Filipino children will have access to and avail of total quality care for the optimal growth and development of their full potential.
Overall Goal	To reduce preventable deaths of all Filipino newborns due to more common and rare congenital disorders through timely screening and proper management.
Program Objectives	By 2030, all Filipino newborns are screened	Strengthen quality of service and intensify monitoring and evaluation of NBS implementation		Sustainable financial scheme	Strengthen patient management
Targets	95% Newborn Screening Coverage	95% Monitoring data are generated from Regional Offices and NSFs through online monitoring system		100% PHIC coverage for ENBS	85% of identified strategically located provinces with established long term management system for confirmed positive patients.
	90% of health facilities with maternity and newborn services that includes expanded newborn screening	100% ISO Certification NSCs and NSRC
		95% of ROs maintained 99% satisfactory sample collection rate
		100% comprehensively trained and certified personnel doing NBS collection in NSFs
Guiding principles	Integration in all child health services	Evidence–based interventions/approach		Quality and sustainability of the program	Partnership and shared responsibilities among agencies
Strategies	Ensuring efficient operations, systems, and networks management	Expanding package of services and delivery network		Enhancing health promotion and advocacy	Optimizing Health Information Management Systems for Expanded Newborn Screening
	Strengthen Monitoring and Evaluation		Establishing Sustainable Financing Scheme