Newborn bloodspot screening (NBS), using biochemical markers to detect certain congenital conditions, is a public health measure aimed at the early identification and management of affected newborns in an effort to reduce infant morbidity and mortality. It is a comprehensive system of education, screening, follow-up, diagnosis, treatment/management, and evaluation that must be institutionalized and sustained within public health systems often challenged by economic, political, and cultural considerations.¹ Initiation of NBS in developing countries, such as many in the Asia Pacific (AP) and the Middle East and North African (MENA) regions has been slow because of a variety of factors. While all countries face challenges in implementing NBS, developing countries face additional challenges related to poor economies, unstable governments, unique cultures, geographic extremes, and different public health priorities.^{[2], [3], [4] and [5]}

The countries in the AP and MENA vary widely in size from very small countries (New Zealand, Singapore, Bahrain, Lebanon, Oman, Qatar, United Arab Emirates) to extremely large countries (China, Mongolia, Algeria, Egypt, Iran, Libya, Saudi Arabia). Some countries are economically developed (Australia, Japan, Korea, New Zealand, Singapore, Taiwan, Israel, Kuwait, Qatar, United Arab Emirates) while others are economically developing (the rest of the AP and MENA Region). Home deliveries continue to be a major challenge in Bangladesh (80%), India (61%), Philippines (62%), Pakistan (80%), Laos (85.7%), Iran (34.4%), Occupied Palestine Territory (38.8%), and Yemen (50%).^{[4] and [6]} The varied written languages pose unique challenges, particularly in regions where the character sets (ie, Chinese, Arabic, Thai) are not readily understood by outsiders. As a result, experts from developed programs cannot easily communicate their experiences and share materials with some in developing programs. Despite these challenges, NBS is a growing priority in many of the more progressive developing countries.^{[2] and [3]}

Successful NBS historically has developed from the efforts of an interested individual or group of individuals concerned with improving the life of newborns and their families. Sometimes, these efforts have taken years to develop. While some NBS programs have been initiated as government services, these generally have been confined to small countries or city-states (eg, Hong Kong, Singapore). For sustainability, NBS eventually must intersect with government public health activities. This evolution often has required a delicate balance of economics, politics, government health priorities, personnel, and other resources. Success in developing and institutionalizing NBS typically has resulted from the continued efforts of dedicated leaders willing to gain proficiency in NBS medical and laboratory science to overcome political, cultural, and economic challenges.

Collectively, we have worked with many individuals and groups that are working to initiate and/or improve NBS in developing environments. Together, and with others, we have identified certain characteristics of developed and developing NBS systems that appear to enhance their chances for sustainability: (1) strong leadership in developing pilot studies and working towards national program implementation; (2) strategic advocacy programs targeted at providing policy makers, health professionals and the public with a basic understanding of the operation and value of NBS; (3) strong collaborations between different stakeholder groups (government organizations, nongovernment organizations [NGOs], and individuals) in planning and implementation; and (4) innovative and sustainable financial strategies.

In this report, we will briefly summarize the status of NBS efforts in a large part of the developing world (the AP and MENA), review some of the challenges in implementing and sustaining NBS in an economically developing environment, and discuss some example approaches and experiences in overcoming internal barriers to NBS implementation. Where possible, we will provide examples of successful activities, often drawing from the experiences of the Philippine NBS program and other progressive developing programs.⁷ We will focus on the NBS activities that are still developing, acknowledging that there are also many developed programs in these regions that can and have served as models for success. In addition to the well-developed programs in Australia, Hong Kong, Japan, New Zealand, Singapore, Taiwan, and Guam, for purposes of this article we will include South Korea, Thailand, and Israel as developed programs and outside of the scope of this discussion.

Current Status of Screening in the Asia Pacific and the Middle East/North Africa

In assessing the global burden of birth defects and congenital conditions, Christianson et al reported that once infant mortality decreases below 50/10,000 births, the genetic and congenital conditions have important health impact.⁸ This is the case in most of the countries in the AP and MENA regions. An overview of the demographics of countries within both regions, including basic information about their NBS coverage, is given in Table 1. In the MENA region, cultural factors have led to larger numbers of consanguineous marriages with a consequent corresponding increased expression of recessive and potentially deleterious conditions in newborns.^{[11], [12], [13] and [14]} Developed countries have shown the importance of NBS in preventing developmental disabilities and reducing infant morbidity and mortality. Thus, NBS has become a program of increasing importance in developing countries. Table 1 summarizes population totals, annual births, gross national income, fertility rates, and percentages of government budgets allocated for health within the AP and MENA regions to highlight some of the obvious challenges in implementing sustainable NBS.

In recent years, 3 NBS conferences have been conducted in the AP and MENA regions to initiate a dialog concerning experiences and needs. These conferences also provided an opportunity to develop a communications network within the 2 regions as a source of support and information sharing. Summaries of the meetings are available online (http://www.newbornscreening-mena.org/index.html; http://isns.napoleon.ch/upload/dokumente/mena%20nbs%20publication.pdf; and http://www.newbornscreening.ph). Two MENA regional meetings have been held; the first in Marrakech, Morocco (2006), and the second in Cairo, Egypt (2008). The first AP regional meeting was held in Cebu, Philippines (2008), with a second planned for 2010. In these meetings, representatives from screening projects and/or health ministries provided updates concerning NBS implementation activities. Experts from developed programs in various parts of the world also attended and provided assistance in developing national “plans of action” aimed at NBS expansion.

At the first MENA conference, participants from 18 MENA countries developed the so-called “Marrakech Declaration,” which states that, “Newborn screening is an important tool in the prevention of disease and disability in our children and thus should be a key part of a comprehensive public health system in all of our countries.” Conference participants recommended that “all countries in the region should screen for at least one condition and develop a national model program that takes into account all aspects for post-testing care.”¹⁵ At the first AP conference, participants from 11 countries in the AP region developed a “Cebu Declaration”¹⁶ with similar language regarding future planning. Despite the relatively simple goal of screening a single condition in each country, many of the low- and middle-income countries in each region face significant implementation challenges, particularly where health systems are stressed.

Challenges in Implementing Newborn Screening in a Developing Country

Our experiences with both developed and developing NBS systems have identified the following 10 challenges to successfully implementing sustainable NBS^{[1], [2], [3] and [4]}:

1 Planning—including basic knowledge and vision, creating a national strategy and systematic expansion to hospitals and other regions, pilot studies, and full implementation, ie, starting the program, validating the value of NBS, and creating a plan for program development, implementation, and sustainability.

2 Leadership—identifying key leader(s) or group(s) to develop and expand the plan, ie, self starters with vision, desire, perseverance, and the ability to lead and accomplish.

3 Medical support—building support within the medical community, ie, fostering medical and scientific knowledge development, collaboration, and consensus treatment strategies (especially in areas where there is lack of metabolic and endocrine specialists).

4 Technical support—providing for technical training and knowledge sharing, ie, proper specimen collection and transport procedures, parent education, quality laboratory testing (including screening, confirmation, and expansion to multiple testing sites), and screening follow-up/tracking (including clinical confirmation).

5 Logistical support—creating mechanisms for obtaining and distributing blood collection supplies, training testing and follow-up personnel, transporting specimens to testing laboratory(ies), providing for screening laboratory operations (equipment, supplies, and maintenance), maintaining appropriate records, and timely reporting of screening results.

6 Education—developing appropriate education and public relations materials for education and support, ie, educating consumers, healthcare providers, and policy makers.

7 Protocol/policy development—developing appropriate screening procedures and policies that adequately address all NBS system components, ie, education, screening (including consent/dissent), follow-up/tracking, diagnosis, treatment/management, and evaluation.

8 Administration—managing the overall screening system, including obtaining and documenting physician and patient compliance, ie, screening, short-term follow-up, and health outcomes (long-term follow-up).

9 Evaluation—developing a comprehensive quality assurance program that monitors critical indicators for success, ie, external laboratory proficiency testing and evaluation of other well-defined system success indicators such as NBS Performance Evaluation Assessment Schemes.^{[17] and [18]}

10 Sustainability—establishing NBS sustainability, ie, integration into the public health system with a plan for financial sustainability (such as inclusion in health insurance schemes).

Elements in Overcoming NBS Implementation Challenges

The 10 challenges outlined above are not easily overcome. Nonetheless, they have been successfully dealt with to varying degrees in all developing programs. The extent of government cooperation and the ability to meet all challenges successfully have directly affected the speed at which NBS has been (and is being) implemented and the extent of newborn coverage. Strengthening local leadership and developing infrastructure have been identified as critical to successful NBS implementation. Also, significant are strategic advocacy activities, such as: support of the health ministry, expert advice, involvement of other government and nongovernment agencies, mobilization of health professionals as program champions, use of the various media (press, radio, television), and knowledgeable parent advocates.

Leadership and Coordination With Government Health Programs

The person(s) or group that seeks to initiate NBS in a developing environment has often observed NBS during studies or visits in a developed setting. The initiator may or may not be a government servant. Regardless, to ensure national coverage, which is the ultimate goal of most NBS programs, the person(s) championing NBS in a developing country must eventually coordinate with the government. This coordination is an important step to sustainability as there are usually many government services and networks that can assist, and considerable manpower that can be used for screening activities instead of organizing duplicative (and sometimes competitive) systems. The presence of an existing maternal and child health infrastructure, for example, has the potential for rapidly providing a mechanism for spreading NBS activities throughout the country (including remote areas) by utilizing nurses, clinics, and other service delivery systems already in place. Some developing programs have found advantages in utilizing other health infrastructures. For example, government hospitals have been successfully used as models for program implementation as their services are more easily controlled through government regulations. Similarly, health clinics and birthing centers managed by the health ministry may be more readily accessible for NBS activities.

Government-run immunization programs have also been used to aid in NBS implementation as they usually include an institutionalized infrastructure. As examples, supplies and specimens have been delivered through transport systems used for vaccine distribution. In some settings, immunization personnel have assisted in collecting specimens at the time newborns receive their first vaccinations. In cases where vaccination schedules may not allow for early specimen collection (when the first vaccination occurs later than the first few days of life), the population-based nature of most immunization systems provides a mechanism for interacting with virtually all newborns (including remote locations). Such an organized system can be important in ensuring that all newborns are provided with a screening opportunity (for some if not all conditions) and in following up on initial unsatisfactory or out-of-range screening results.

Where public health education systems and/or public health educators exist, these systems and/or personnel have often been available for a wider range of health-related educational activities, including NBS. Because public health education systems usually include materials distribution mechanisms and means for evaluating patterns of usage, they are ideally situated to aid in producing and distributing NBS educational pamphlets. In this way, the developing NBS program can operate inexpensively without the need to duplicate infrastructure expenses already incurred in the healthcare system. Experienced program personnel already in place can also provide insights into efficiency and effectiveness that might otherwise take significant amounts of time to develop.

Record Keeping

Developing NBS programs should be able to profit from lessons previously learned by developed programs. One such example involves record keeping. Already existing health records systems in the public health sector can provide a ready mechanism for recording NBS information. The Philippine NBS program, for example, has been able to use such a system for rapid evaluation of the extent of its program services. In this case, every health professional can check the NBS status of an infant at the time of the first healthy infant visit by checking to see whether there is a date recorded for NBS in the appropriate box in the immunization record (Fig. 1). If there is no indication that screening occurred, the parent can be offered NBS at that time.

Policy Development

NBS policy development requires knowledgeable individuals to administer the technical details of the program and competent government officials to ensure accessibility and sustainability within the public health system. Properly developed and administered health policies must include assignment of responsibilities for health program implementation and administration at all levels of operation. Policies governing the system should include plans of action for organizational structures that provide adequate system implementation at the local level. Without integration into the public health system, NBS programs are not sustainable at the national level.

Legislation

Governments usually maintain the public's health through policies that may be established through governmental proclamations, laws, policies, administrative orders, or policy-related rules and regulations. While most developed NBS programs have successfully accomplished health care integration without legislative requirements, at least 2 of the developing programs highlighted here (China and the Philippines) have found national legislation to be helpful. In China, Presidential Order Number 33, Article 24 (1994) stated that, “medical and health institutions shall gradually develop medical and health care services such as the screening of newborn babies.”¹⁹ In the Philippines, Republic Act 9288, Article 1, Section 3 (2004) states that, “every newborn must be given access to newborn screening” and Article 3 states that, “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.”^{[20] and [21]}

Rights of the Child

The United Nations (UN) Convention on the Rights of the Child requires signatories to “recognize the right of the child to the enjoyment of the highest attainable standard of health” (Art. 24(1)). In ensuring these rights, parties are to take appropriate measures to “diminish infant and child mortality” (Art. 24(2a)) and to “ensure the provision of necessary medical assistance and health care to all children with emphasis on the development of primary health care” (Art. 24(2)).²² Most countries have signed agreement to this convention. The UN Convention on the Rights of the Child has been particularly useful in approaching government policy makers in the developing world regarding NBS. Recognizing the “Rights of the Child” often has been used as part of the arguments for persuading government policy makers of their responsibilities in providing NBS as a preventative measure for improved newborn and child health. Both the Marrakech and Cebu Declarations make reference to the UN Document.^{[15] and [16]}

Advisory Committees

Developed screening programs usually have a NBS advisory committee of some type, not only for advice but also for professional assistance and advocacy.²³ Aside from technical expertise, the advisory committee also includes individuals who can adequately represent professional and community groups interested in or affected by NBS. In most developing programs, it has also been useful to have an advisory group, particularly to achieve buy-in from professional healthcare providers and consumers as the program develops. Because the committee approach is often slow and deliberate, particularly when it is multidisciplinary and the knowledge level is low, most developing programs have found it expeditious to use advisory groups sparingly until the groundwork for the program has been laid.

Strategic Advocacy Programs

Education programs (for consumers, health care professionals, and policy makers) and public relations activities have been found to be essential for successful implementation of the NBS system. Without support from the local medical/paramedical community and medical specialists, NBS advocates face an uphill battle. Whether implemented in the hospital or community setting, the health professional plays a key role in educating and motivating families about the importance of NBS. The families, in turn, can assist the health professionals in convincing policy makers to expand and assist in sustaining NBS at the national level. Successful developing programs have been creative in their educational approaches, including ensuring cultural and educational appropriateness. As an example, the Philippine NBS program has created various books, educational CDs, and manuals for professionals working within the system, and a basic reading level comic book has been created for parents (information on manuals available at http://www.newbornscreening.ph). As with developed programs, developing programs have also created local cook books for parents of children with metabolic problems requiring special diets.

Expert Assistance

External experts with experience in developed settings often have been used by developing NBS programs to present educational seminars to professionals, policy makers, and consumers. Their presence, in some cases, has been useful in adding a sense of program legitimacy for policy makers. As part of the activities of the MENA effort, experts in NBS for congenital hypothyroidism prepared flip chart educational materials for local advocates to use in convincing government policy makers of the importance of screening and to answer their basic questions about program development. These materials were developed in English, French, and Arabic and are available on the MENA Web site (http://www.isns-neoscreening.org/htm/isns_regions.htm). A reference book based on experiences in the AP has also been produced.²⁴

Health Ministry Support

While many NBS programs have originated outside of the public health system as either private (individual or collaborations) or corporate (commercial) efforts, none have developed into national systems reaching the full population of newborns without the support of the health ministry. Private entrepreneurs often have begun NBS in an effort to reach portions of the population (most notably the private pay clients), but full population screening, including the indigent population, has usually not been the goal of nonpublic health systems. Methodical development of NBS system infrastructure and assessment of the conditions for which NBS can be most productive ultimately must include integration into the public health system. To accomplish this effectively requires political awareness and perseverance. While the public health system has sometimes been reluctant to take the lead in implementing NBS at the grassroots level, the reluctance has usually diminished as the program has been shown to be successful in reducing childhood morbidity and mortality. For example, NBS programs in the Philippines, Egypt, Qatar, and Abu Dhabi now have full government support. While coverage in the latter 3 countries is essentially 100%, government support in the Philippines is relatively recent and coverage has expanded from 5.2% coverage to 30% coverage in the 5 years that it has been a part of the government public health system.^{[4], [20] and [25]}

Other Government Support

Many other examples of government participation exist, including: (1) addition of NBS into the required curricula of health-allied courses (such as medicine, nursing, and midwifery); (2) involvement of government employees (physicians, nurses, and midwives) in advocacy campaigns; (3) use of other government funds for support services such as production of informational materials (in the Philippines, China, Egypt, Iran, and others).

Health Professionals and Hospital Involvement

Especially in beginning programs, it is important that general physicians, pediatricians, obstetricians, health administrators, and other private practitioners have information on the history of NBS, the rationale for its existence, benefits to individual newborns, families and society, financial strategies, and future plans. The goal is to make every health care practitioner into a passionate advocate of the program. Rewards for performance in reaching program milestones have been effective in encouraging program participation in some developing settings. As an example, in the Philippines, biennial awards have been routinely presented to hospital management and individuals to acknowledge their contributions in significantly increasing newborn screening coverage (Fig. 2). Contests have been held to encourage advocacy through posters in hospital waiting areas, and banners have been displayed in front of hospitals participating in NBS advocacy programs. Billboards have been used to advertise the importance of NBS and videos are often available in hospital waiting rooms.

Media

Tri-media campaigns have proven extremely useful in accelerating community support for NBS. In most developing countries, a significant percentage of the population is most easily reached through the various public media, ie, radio, television, and newspaper. Therefore, NBS advocates in developing countries sometimes avail themselves of opportunities on television and radio talk shows. Television and radio public service announcements and magazine and newspaper articles are other successful public relations strategies. Both health professionals and parents have been used to endorse NBS programs in the media. Extensive media campaigns have successfully affected NBS start-up activities in the Philippines, and are being implemented in Libya and Jordan, among others. The media have also played roles in tracking down patients for follow-up in situations where screening results have indicated a significant health problem and there is difficulty locating the family. New smart phone technologies provide additional strategies for both educating the population and tracking children identified through newborn screening.

Parents

Parents (private citizens) have been responsible for significant successes in NBS in developing programs. Parents of infants that have been spared the consequences of a devastating congenital condition often have become dedicated advocates of the screening program. They have assisted in creating a demand for NBS in communities or hospitals where skepticism has previously existed. In the Philippines, an advocacy/informational videotape in Tagalog describes the value of NBS. Parents with children suffering from late diagnosed conditions that could have been prevented by NBS have graciously agreed to have their children featured alongside of detected and saved children in media advertisements for NBS. Billboards (Fig. 3), posters, and web pictures depict 2 children—1 saved by screening and 1 who was not (Fig. 4). These pictures have provided “faces” to NBS and encouraged parents to obtain screening when they might not have done so otherwise. Policy makers have also been affected by these faces of newborn screening.

Non-Government Organizations

In addition to the government sector, the NGOs have also played a significant role in NBS in the developing world. NGOs include academic institutions, health professional societies, insurers, civic organizations, sectarian and religious groups, and other organizations in the public. Professional societies have advanced NBS through policy statements and other professional activities and advocacy. Academic centers have played major roles in managing and treating patients identified through screening, monitoring treatment and/or compliance with treatment, and providing expertise for developing training and educational materials.

Public service organizations such as the Lions Club International and Rotary International are examples of organizations providing funding for such items as informational materials, laboratory equipment, laboratory facilities, and services for charity patients. The UN Children's Fund (UNICEF) has provided support funding for the production and distribution of informational brochures on newborn screening in several developing countries. The March of Dimes Birth Defects Foundation has provided financial support for expert NBS speakers at national and regional meetings. Sectarian and religious groups have also influenced certain populations to accept the principles of screening. In some countries, like the Philippines, NBS concepts have been integrated into certain religious activities such as prenuptial seminars for couples. In cases where there is an NBS fee and NBS coverage is not included in their insurance program, early recognition of the importance of NBS allows parents the opportunity to save money for screening.

Program Institutionalization

To be sustainable, NBS must be developed as a comprehensive system. Formal recognition and institutionalization of the NBS program as a public health program is one of the most important steps in implementing and sustaining NBS. The US Association of State and Territorial Public Health Officials (ASTHO) has recently recognized NBS as a “core” public health function.²⁵ A 6-component NBS system was noted in the Introduction to this report. All of these components must exist in a developing screening system: (1) screening—specimen collection and quality laboratory testing; (2) short-term follow-up—tracking and confirmatory testing; (3) diagnosis—through clinical specialists; (4) management—using appropriate pharmaceuticals and appropriate dietary management; (5) evaluation—documentation of patient compliance and improved health outcomes, and external laboratory proficiency testing; (6) education—for consumers, health professionals, and policy makers.¹

Prompt recall of patients suspected with disorders identified through screening is one of the critical parts of the system. Government public health clinics and outreach programs in developing settings have provided a means of patient contact that has been particularly useful in both rural and urban settings. In the urban environment, government clinics and government hospitals, which are usually available to most of the population, have been used as part of the NBS follow-up system. In rural areas, public health nurses, local clinics, and an informal health network have usually provided the necessary follow-up.

For successful screening, specialty care (pediatric endocrinology and metabolic physicians) must be available and accessible to assist with proper diagnoses and patient management. In developing settings, specialty care is limited and may be available only at, or in conjunction with, government hospitals or medical centers. Limited access may also exist in the private sector. In cases where a specialty provider is not readily available, developing programs often find it necessary to rely on a physician who has had experience with the screening disorder in training, or who may have a special interest in the disorder. In some cases, specialists may be contacted electronically or by telephone for assistance, and telehealth is an increasing priority in developing countries. In addition to specialty care challenges, there are also issues that must be addressed regarding pharmaceutical supplies. Medical foods, formulas, and pharmaceuticals are often difficult to obtain in a developing country and relationships with suppliers outside the country have been useful in both implementing and sustaining some of the treatments necessary for screened conditions. Parent advocates in developed countries have sometimes assisted in providing limited supplies and drawing attention to national needs.

Once NBS has been implemented, continuing education becomes a priority. Because human resources are scarce and time limitations often preclude extended training for large numbers of workers, workshops that “train the trainer” have been popular, sometimes on a regional level. As an example, the International Atomic Energy Agency (IAEA) has sponsored regional workshops in the AP to train laboratory specialists in testing procedures for congenital hypothyroidism (CH). Similar workshops have been held for program administrators and follow-up coordinators.²⁶ Programs that have been successful in expanding nationally have provided similar training in various regions of their countries. The Japanese International Cooperation Agency (JICA) has also provided initial training and ongoing support to developing NBS programs.²⁷ Many educational resources are available from developed and more advanced developing programs and most have found it prudent to supplement their training activities with these materials (videotapes, various books and pamphlets, protocols). Once training materials are developed locally, it is a simple matter to update and redistribute them periodically.

The logistics of specimen transport and result communications have required special attention in many developing countries. Mail is often not reliable and so it has been necessary to work locally with organizations that specialize in these services to develop sustainable systems. In some cases, special shipping arrangements have been made with courier, bus, and postal services. In climates where heat and humidity might compromise specimen integrity, special attention has been paid to transport in air-conditioned vehicles or special packaging. Result reporting has been facilitated by special telephone, telefax, or other special telecommunication arrangements. Where test results have required immediate (emergency) follow-up, government police and media announcements have been used to locate families.

Financial Sustainability

The ideal situation for financial sustainability in a developing program is full government support. However, because of other competing health priorities, full government support of NBS is usually not possible. As a result, developing programs have been faced with the challenge of innovation in their financing approaches. Often, small grants have been used for initial planning and pilot testing, but long-term financing in this way is not practical. For many developing programs, initial screening efforts have required a small fee paid by the family. Unfortunately, there is extensive poverty in countries where NBS is developing and even a small fee can be a challenge to many families. In contrast, the NBS fee is usually substantially less than other prenatal medical services in these settings, and is considered a bargain relative to other healthcare costs.

Most NBS programs (developed and developing) develop plans to ensure that the entire newborn population can access NBS, regardless of their ability to pay. While this may not be possible in the early implementation of a developing NBS program, the goal is always present and sustainability planning must include financial support for those who cannot pay. To offset screening fees (where they exist), some programs, most notably the Philippines,²⁰ have developed financing strategies and educational programs to encourage parents to save for this expense. In some cases, altruistic organizations and local governments have provided financial assistance through gifts or loans to lower or eliminate costs. To be totally sustainable at the national level, NBS must ultimately be a part of government and private insurance. Programs in Egypt, Jordan, and the Philippines provide successful examples of inclusion in government insurance programs.

Financing is usually handled by the central administration of a NBS program. Because adequate program funding is essential, most NBS programs spend considerable time and effort developing appropriate costing data and planning program finances. In cases where fees are necessary, a sound billing and collection system must exist, and the fee must be comprehensive (ie, it must include the items necessary for sustainability—education, screening, follow-up). Two primary fee collection mechanisms exist: (1) direct billing to the birthing facility following testing, and (2) billing for NBS collection cards purchased before screening. The former requires the program to pay for itself pending payment after testing, while the latter can be established in such a way as to have the collection kits paid for in advance of testing. Both systems have been used in developing programs.

Program Quality

As with developed NBS programs, quality assurance and program evaluation are essential to sustainability. Where quality does not exist, programs cannot maintain the confidence of the public or the medical community and they soon fail. Various program evaluation schemes have been used in developing programs, but all include some form of data accumulation and review. Laboratory quality management has generally used internal controls and standards supplied by reagent kit manufacturers, and external proficiency testing from sources such as the US Centers for Disease Control and Prevention²⁸ and others.^{[29], [30] and [31]} NBS laboratory services are not limited to screening laboratories alone, and diagnostic laboratories that are part of screening confirmation must also be included in quality considerations. Because evaluation of nonlaboratory components of the NBS system are equally important to sustainability, the NBS self-evaluation process used in the United States¹⁸ has been encouraged for use in defining various system elements. However, the complexity of developed systems can be overwhelming to a developing program, and so using the US Performance Evaluation Assessment Schemes as a guide, several developing programs have created their own evaluation systems.¹⁷

Conclusions

Changing demographics and advances in technology and treatment for rare conditions has led to increased interest in newborn screening in developing countries in general, but particularly in the AP and MENA. Heterogeneity of population size, income, health systems, and infrastructures has contributed to varied NBS experiences across both regions. Recent regional meetings in both the AP⁶ and MENA⁴ have led to commitments to increase screening activities, which have been formalized in the Cebu¹⁶ and Marrakech¹⁵ Declarations, respectively. These declarations provide a valuable first step in implementing and sustaining NBS in the countries in both regions. The challenge of institutionalizing a screening program for a single condition in countries with little screening activity, expanding a pilot project to a national program, and expanding limited disorder screening to multiple disorders requires diligence in successfully meeting the challenges outlined in this report.

To date, a limited number countries in the AP and MENA report having national NBS programs that screen for at least 1 condition. These include the Philippines, Egypt, Iran, the Palestinian Authority, Bahrain, Oman, Qatar, and the United Arab Emirates. In several of these, multiple conditions are screened. Various strategies have been used, but all have included integration into government programs and some form of public-private cooperation. In the Philippines and Qatar, initial screening activities involved outsourcing specimens to developed screening laboratories in Australia and Germany, respectively. This may provide a usable model for some of the later developing programs.

While most programs have focused on initial screening for congenital hypothyroidism, which is known to be cost-effective in most screening settings, tandem mass spectrometry (MS/MS) for metabolic conditions has also been embraced by some developing programs. While considered expensive and technically challenging, MS/MS screening for metabolic conditions will likely prove cost-effective in developing countries where consanguinity leads to increased incidence of metabolic conditions. Ongoing MS/MS pilot studies in Lebanon,³² Qatar,²⁵ and Saudi Arabia⁵ should provide useful information for other countries in the MENA region. Indeed, they may provide regional resources for testing that can be utilized by neighboring countries. Similarly, MS/MS data from projects in China³³ should provide useful cost-benefit and incidence data with implications for the large AP screening population there.

In addition to the regional meetings previously described, other forms of international collaboration have provided opportunities for meeting the challenges of establishing and strengthening NBS in developing countries. The IAEA has provided limited support (technical training and administrative support) for CH screening in many AP and MENA countries.27 K.K. Solanki, Training programmes for developing countries, J Inherit Metab Dis 30 (2007), pp. 596–599. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (3)²⁷ For many years, JICA has provided NBS training courses for developing countries both within and outside of the AP and MENA regions.²⁸ Commercial initiatives throughout both regions have provided innovative pricing for reagents and equipment that has encouraged NBS growth and expansion. Experts from various developed programs have contributed time and energy to training and transferring knowledge to many of the developing programs. Likewise, progressive government officials in some of the developing countries have provided necessary support that has led to increased program implementation and expansion.

In the future, new communication technologies may play a large role in educating parents and professionals about NBS. Likely, these technologies will have a large impact on the developing world, including issues of technical support and data collection in remote locations. Strategic planning will continue to be critical to sustainable NBS, and multinational collaborations will continue to provide necessary support. National and regional data collection will provide the necessary information for policy decisions, and the development of international information technology standards and common definitions will assist in this effort. Finally, development of new, low-cost, point-of-care nanotechnologies for testing newborns for a broad range of conditions may provide new strategies for testing and following up affected children.