A performance evaluation and assessment scheme (PEAS) for improving the Philippine newborn screening program

Newborn Screening in the Philippines began as a small pilot project in Manila in 1996 and has expanded to a nationwide program screening for 5 conditions today. Along the way, professional, political and public support has increased. As a result, a national law requiring the offering of screening to all newborns was put into place. The Department of Health (DOH) is actively providing follow-up support, and the National Institutes of Health - University of the Philippines Manila (NIH) provides laboratory and technical expertise. Expansion has evolved to the point that there are now two DOH accredited screening laboratories with further expansion anticipated. The Newborn Screening Reference Center at the NIH has partnered with the DOH to develop a performance evaluation and assessment scheme (PEAS). The Philippine PEAS is designed to monitor quality and improvements made in the regional DOH screening program. The Philippine PEAS was developed building on a PEAS previously developed by the US National Newborn Screening and Genetics Resource Center, and we report here the development, implementation and results of the Philippine PEAS.

Challenges and opportunities in establishing and maintaining newborn screening systems.

Newborn screening began in the early 1960s and during the four decades it has existed, has become a recognized vital public health prevention program. It has evolved conceptually from a laboratory test for a single disorder, phenylketonuria, to a comprehensive 6-part public health system of education, screening, follow-up, diagnosis, management, and evaluation. Newborn screening in different countries has been successful because of the efforts of a single individual or group of individuals interested in improving the health of children. Newborn screening has been shown to successfully detect serious disorders before symptoms appear and to significantly reduce the morbidity and mortality that might result if left undetected and untreated, yet there have been (and continue to be) obstacles to implementing newborn screening programs. The obstacles are the same for developed or developing programs and include: (1) adequate financing, (2) technology implementation, (3) program logistics, (4) cultural sensitivity, (5) education, and (6) political support. All newborn screening programs must exist within the limitations of their local environment in this regard. Each program confronts these barriers in its own way and various examples of overcoming barriers are discussed including linkages to immunization programs, regional planning, program advocacy, and legislation.

Ethical, legal and social issues in newborn screening in the United States.

Four million babies are born annually in the US. There are 51 separate laws mandating universal screening and each has its own restrictions. Forty-nine programs allow the parents to "opt out" of testing (dissent), and 2 programs allow the parents to "opt in" (consent). The extent to which these decisions are "informed" varies and in most cases, no information exists as to whether the parents knew or understood what the newborn screening program entailed. Most programs have educational material available describing the state program but whether this information is the information needed (in terms of literacy level and content) to provide a sufficient understanding of the program is not generally known. In most programs, testing is automatic and the program information is contained in the hospital materials given to the mother upon entry or exit from the birthing facility. All newborn screening programs are administered by the state public health agency and ultimately the state legislatures are responsible for creating the laws governing newborn screening. Financing mechanisms are complex with fees varying from $0 - $60 and not directly related to the number of disorders screened, although system components such as education, methods of sample collection, sample submission, laboratory testing, follow-up, confirmation, diagnosis, treatment, outcome and quality assurance are considered in most fee setting processes. The standards for programs have developed over the years at least partly as a result of medical-legal confrontations. During the past several years there has been a notable increase in program expansions including expanded biochemical testing and screening for hearing loss. In 1999, the Maternal and Child Health Bureau funded a newborn screening task force to review the issues facing state newborn screening systems and to make recommendations for improvements and/or changes in these systems. Two primary issues of ethical, legal and social consequence were considered: (1) the inclusion of diverse groups (including consumers) in newborn screening decision making, and (2) existence of adequate policies regarding privacy, consent, and research ethics. Following extended review and discussion, the Task Force recommended greater emphasis on parent education, permission for testing, and prenatal education. It was also recognized that studies should be carried out to improve parental understanding of newborn screening and the informed permission process, and to improve the public's overall understanding of the screening process.

Data integration and warehousing: coordination between newborn screening and related public health programs.

At birth, patient demographic and health information begin to accumulate in varied databases. There are often multiple sources of the same or similar data. New public health programs are often created without considering data linkages. Recently, newborn hearing screening (NHS) programs and immunization programs have virtually ignored the existence of newborn dried blood spot (DBS) newborn screening databases containing similar demographic data, creating data duplication in their 'new' systems. Some progressive public health departments are developing data warehouses of basic, recurrent patient information, and linking these databases to other health program databases where programs and services can benefit from such linkages. Demographic data warehousing saves time (and money) by eliminating duplicative data entry and reducing the chances of data errors. While newborn screening data are usually the first data available, they should not be the only data source considered for early data linkage or for populating a data warehouse. Birth certificate information should also be considered along with other data sources for infants that may not have received newborn screening or who may have been born outside of the jurisdiction and not have birth certificate information locally available. This newborn screening serial number provides a convenient identification number for use in the DBS program and for linking with other systems. As a minimum, data linkages should exist between newborn dried blood spot screening, newborn hearing screening, immunizations, birth certificates and birth defect registries.