1. DPH Family Health Branch
2. DPH Epidemiology Section, Maternal and Child Health Epidemiology Unit
3. DPH Health Assessment Section

1. DPH Family Health Branch—provide technical assistance and consultation to district and county health offices and providers in the implementation of public health programs.
2. DPH Epidemiology Section, Maternal and Child Health Epidemiology Unit—responsible for data management, surveillance and evaluation activities
3. DPH Health Assessment Section—oversee system development and implementation

Of the 126 birthing hospitals in Georgia, 30 currently implement universal newborn hearing screening, covering 30% of the newborns. At an additional 23 hospitals, high-risk newborns are screened under doctors’ orders, covering an additional 10% of newborns. Hospitals currently use self-established protocols for screening and follow-up, and except for the Waycross and Macon areas, lack comprehensive community-integrated systems for screening, referral, tracking, intervention and follow-up.

1) assuring screening, diagnosis, and interventions by tracking individual infants/children

2) describing and monitoring hearing loss in infants and children through surveillance

3) improving unit level and system functioning with quality assurance to determine performance of reporting sources and exceptions that require follow-up

4) evaluating GEHDI to assess the impact of screening and early intervention on health status outcome

The proposed tracking and surveillance activities pose the challenge of coordination with the existing decentralized and informal systems of the 159 local health departments, 117 of which are rural. The coordination will exist at the level of the Children 1^ST staff, who provide a single entry point for infant and child public health services in each of the 19 health districts, and who will assume responsibility for referral follow-up of identified children, as well as those needing initial screens. Entry into the system will be coordinated with the state’s Electronic Birth Certificate system.

In Year 1, the project database administrator and epidemiologist will be recruited. Beginning in March 2001, tracking data will be reviewed to identify exceptions. Testing of the software system is to be conducted in March of 2001, with the distribution of the final version in September 2001. Until then, tracking information will be provided to the DPH with a paper system.

In Year 2, the GEHDI tracking system will begin to include children with late-onset and progressive hearing impairment. Potential identification points are case reports from ENTs and audiologists and existing Georgia surveillance systems for conditions such as traumatic brain injury (TBI), meningitis, congenital rubella syndrome, etc. that are risk factors for hearing impairment.

• Review parent concerns and make recommendations.

GRANT NARRATIVE

Georgia Early Hearing Detection and Intervention (GEHDI) Tracking/Surveillance - Level I

In a relatively short time period (less than two years), Georgia has moved from small-scale, isolated, and fragmented newborn hearing screening activities to the verge of implementing a statewide universal newborn hearing screening (UNHS) system. Legislation has been enacted; a mandated advisory committee is functioning; substantial resources for equipment, screening, evaluation, follow-up, and systems development have been obtained; protocol development is underway; training is being planned; a public/-family education campaign is being launched; and the electronic birth certificate has been modified. One critical element remains underdeveloped - the data and evaluation component necessary to support tracking and follow-up of infants, perform quality assurance, and provide surveillance information to direct policy decisions and program planning. This proposal describes the Georgia Division of Public Health (DPH) plan to implement this component.

I. Problem

A. Overview of Concern

With the growing understanding of language encoding beginning at the age of six months, and the criticality of early identification of and intervention for infants with hearing impairment (HI) to mitigate life-long educational and social deficits, the threshold age for identifying these babies has dropped to birth. School entry or primary grade hearing screening, followed by fitting of hearing aids and speech therapy, cannot compensate for the "sounds of silence" during infancy and pre-school years. Yet, in the Atlanta, Georgia metropolitan area, based on the Centers for Disease Control and Prevention (CDC) "gold standard" Metropolitan Atlanta Developmental Disability Surveillance Project (MADDSP), only 8% of children with a HI (>40 dBs., better ear) were diagnosed by their first birthday, with 47% not diagnosed until over age three; 17% of children were not identified until after five years of age. As one of the few population-based, developmental disability surveillance systems, MADDSP findings are commonly extrapolated to other populations. Thus, a similar pattern in the rest of Georgia can be presumed.

No uniform collection system for HI data exists in Georgia. Information from several administrative data sources describes the extent of current UNHS activity in Georgia and the incidence of hearing loss among Georgia children. The latest data (1998) indicates that 30 of the 95 birthing hospitals delivering ?100 babies conduct UNHS; these infants represent 30% of Georgia's 120,000+ annual births. Screening of high-risk babies based on a doctor's order is occurring at 23 other hospitals. Minimal referral and follow-up information is available. Currently, 325 pre-school-age children with HI are known to Georgia PINES, a statewide parent-infant network for educational services. Through Part B of IDEA, the public school system is serving 1,295 children with HI and 15 children who are deaf-blind, ages 6-21, and 190 children with HI and 3 who are deaf-blind, ages 3-5. The racial/ethnic make-up of those ages 6-21 is: 55% white, 38% African American, 4% Hispanic, and 2% Asian. In the 1996-97 school year, 112,392 primary-grade children had hearing screening through a DPH-sponsored program; 2,215 students were identified with hearing problems. Children's Medical Services (CMS), the Title V CSHCN program, had 3,298 children (5/99) enrolled with a hearing problem; their diagnoses are reflective of a broad range of hearing-related medical conditions and degrees of hearing loss.

B. Challenges, Barriers and Problems in EHDI Development and Implementation

Two broad, interrelated areas exist in which challenges, barriers, and problems in the development and implementation of a UNHS system are present. One group is programmatic while the other focuses specifically on surveillance and tracking, and related data issues. Although this proposal emphasizes surveillance and tracking, programmatic issues directly impact the former and an understanding of both is necessary to assess DPH's current situation and future direction related to the establishment of a surveillance and tracking component for the larger UNHS system. The assessment below is a direct result of DPH activity related to the implementation of House Bill (H.B.) 717, passed in 1999, which sets a UNHS screening goal of 95% of infants and establishes a State Advisory Committee on Newborn Hearing Screening (SACNHS) to recommend actions to achieve this goal. The assessment was further informed in the course of recent, successful efforts to obtain state Tobacco Master Settlement Agreement (MSA), Health Resources and Services Administration Maternal and Child Health Bureau (MCHB), and Appalachian Regional Commission (ARC) funding for UNHS.

Programmatic concerns in several areas have been identified. Concerns include system development, both at the public health and hospital/community levels; adequate expertise and skills to conduct screening, follow-up, evaluation, diagnosis, and intervention; operating within the critical six-month postnatal period; reimbursement limitations; public and professional awareness and education; and mechanisms for post-discharge follow-up and evaluation. A brief summary follows.

Expansion of screening: With the current screening level at about 40% of Georgia newborns (UNHS and doctor-ordered), the overall screening level must more than double to reach the State goal of 95%. The most prominent difficulties cited in accomplishing this objective are equipment costs, insurance reimbursement policies, instituting changes in hospital procedures, and staff training.

Establishment of uniform protocols for screening, referral, evaluation, diagnosis, and intervention: Presently, hospitals conducting screening activities are doing so using self-established protocols. While some hospitals adhere to national recommendations, many do not and lack a comprehensive systems approach with standardized procedures for screening, referral, and follow-up.

Training and technical assistance (TA) for multi-disciplinary professionals: Presently, in Georgia, training/TA is available only from screening equipment manufacturers. Their support focuses on the use of equipment by hospital staff and audiologists, and does not address broader systems and service provision issues or the other health professionals involved in comprehensive UNHS. Two types of training/TA are needed: 1) expertise regarding HI, particularly in infants, and resources for early intervention; and 2) relevant skills based on roles and responsibilities, as set forth in protocols and community plans. A state-funded DPH training contract meets core, initial training/TA needs, but does not offer the focused and/or on-going assistance required to fully implement and sustain UNHS.

Development of community-level service plans: Except in the Waycross and Macon areas, screening has not been integrated into a community-specific plan for referral, follow-up, tracking, and intervention that: 1) identifies audiologists and ENTs; 2) designates staff roles and responsibilities for tracking and family advocacy and support; 3) establishes intervention resources; and, 4) details data collection and quality assurance activities. Such plans need to incorporate the unique relations of each in-hospital screening facility with the shared resources of the community.

Creation/maintenance of a resource inventory database: A centralized Georgia resource inventory (e.g., hospital screening status/contact information, audiologists accepting infant patients, community support programs, program eligibility/insurance reimbursement, etc.) does not currently exist. Information is inconsistent, incomplete, and anecdotal. Reliable and valid baseline data against which progress can be measured is not available and inquiries from professionals and the public cannot be readily answered.

Changes in reimbursement policies: With the advent of new state funding for screening, diagnostic evaluation, and intervention focused on supporting costs where other third-party payment is absent, efforts are required to maximize reimbursement from Medicaid and private health insurance plans to leverage available state funds. Substantial progress has occurred to overcome Medicaid barriers, but anecdotal information regarding private insurance coverage indicates strenuous efforts focused on these plans' policies and procedures are needed.

Paradigm shift to address possible infant HI as a critical health situation: The critical six-month postnatal period for identification of and intervention for infants with hearing loss is not widely recognized by health professionals and families. Education and social marketing is needed to make "possible HI" a red-alert, generating immediate and concerted actions by health providers and families. This effort should be rooted in broader awareness regarding the frequency and impact of congenital HI, screening, and available intervention.

From a tracking system and surveillance perspective, DPH confronts an array of challenges, barriers, and problems as it develops and implements GEHDI (Georgia Early Hearing Detection and Intervention), our UNHS system. These concerns, addressed through the activities proposed in this application, fall into two broad categories; external issues related to the UNHS structure and activities and internal ones inherent to DPH. A summary of these issues follows.

External Issues:

Tracking the child in an open system -- Recognizing local autonomy as a hallmark of service delivery, in Georgia, the UNHS system being implemented is an open, decentralized system. This means that the screening, follow-up, and diagnosis process will vary from hospital-to-hospital, community-to community, and child-to-child. With a different set of "partners" who hold key tracking data for each child referred from the initial screen, developing a system that accommodates the variation will be a major challenge. This will necessitate establishing a simple, user-friendly system with well-defined reporting elements as well as extensive initial training with on-going technical support. As reporting extends to children with acquired HI who have a different system entry point than infants, data tracking demands will be further complicated.

Accommodating multiple service delivery providers -- Not only does data need to be collected from those conducting screening and diagnostic evaluation during the initial window period after birth, but longitudinal data are required for those diagnosed with HI. With a diffuse care delivery system involving health providers, therapists, and educators, each with their own set of data needs, establishing a reporting system with separate, though inter-locking sets of data elements is difficult. Compounding this is the basic problem of getting buy-in from the large number of "reporters" who often lack an inherent reason to provide data to DPH. Clearly relating the benefits of reporting to this audience, as well as substantial training efforts will be essential.

Strengthening the system of care coordination -- The primary intersecting point in the UNHS system are the Children 1^st coordinators in the local health departments who have responsibility for identifying, referring, and tracking infants and children with defined risk conditions. They will be a pivotal point in the system, one through which much of the data flows, and both their own buy-in to the system and their engagement of providers in their geographic area will be paramount. Moreover, they will require the expertise, skills, and practical tools to facilitate care coordination and reporting.

Availability/cost of site-level software - While funding is available for screening equipment, except for software that may be built into the equipment, no funding is available for site-level data management software which serves as the source for screening and follow-up data. Provision of such software is complicated by the openness of the system which means that a common package is hard to purchase or develop. This issue extends to the 159 local health departments that operate on at least three different data platforms.

Resistance/reluctance related to information sharing - During our preliminary assessment activities, resistance or reluctance to share information related to identified infants has been expressed by hospitals and health service providers, as well as parents. While H.B. 717 and public health reporting authority, along with focused education, may facilitate hospital and provider reporting, the necessity for parents to waive information-sharing restrictions to enable data reporting at all points in the continuum (screening diagnosis service/intervention provision outcome measurement) poses a significant concern. Acquiring the cooperation of parents becomes more difficult as the general concern about the confidentiality of health information increases.

Size/dynamics of system - Rolling-out a surveillance and tracking system that may involve 100+ hospitals; 3,000+ pediatricians, family practitioners, and specialists; 300+ audiologists; and several hundred speech and language pathologists is daunting in terms of their involvement and training. Since this group is not static and an on-going need exists to continually identify new reporting partners, engage them, and provide them with training and technical support, the need for dedicated marketing, training, and support resources looms large.

Internal Issues:

DPH/CDC data system requirements - In an effort to improve data quality and usefulness, DPH has recently instituted a data policy setting parameters, standards, and requirements for all activities that involve data collection. (See DPH Data Charter, Appendix A.) This requires that the work of this project adheres to the Charter's policies and processes in defining data elements, detailing specification, and identifying the level of measurement and unit of analysis as well as in dealing with logistics related to actual collection of data. Concurrently, CDC requirements described in the "National Database for Newborn Hearing Screening" (4/99) and subsequent documents will need to be aligned with the DPH policies and processes.

Resource demands on current capacity - The capacity of the existing system that relies upon the download of data from the electronic birth certificate (EBC) by local Children 1^st staff to identify infants at risk, and the information technology system that supports this effort, will be strained by the influx of a large number of "at-risk" infants who are referred following the initial screen. The EBC download, a relatively new approach, has not been rigorously tested as an entry point into a highly structured system for follow-up, referral, and tracking of large numbers of infants. Nor has Children 1^st staff dealt with the level of demands related to timeliness of follow-up and assurance of service that UNHS will require for this number of infants.

System limitations - Given the available resources and other issues discussed, acceptance of UNHS surveillance and tracking being limited to a passive system must occur. While these issues remain, the rigor and detail of more active case-finding and reporting such as the MADDSP will be lacking.

C. Current Status of GEHDI

History of DPH Involvement: DPH has 50 years of experience providing hearing screening. Beginning in 1949, screening was conducted through the Crippled Children's Program and since then, several approaches have been used. In 1974, DPH hired its first (and current) hearing/vision consultant, Adam Roche, M.Ed. (See CV, Appendix B.) That same year, DPH purchased Crib-o-gram equipment for major birthing centers to screen high-risk infants; this was the first effort in newborn hearing screening. A law passed in 1978 established screening for infants at risk for vision and hearing problems, however, funding to support the legislation was never provided and limited activity ensued. In the early 1980s, Mr. Roche and Michael Lavoie, the Vital Records Director, worked together to modify the birth certificate and create a high-risk infant registry in the Vital Records Office. On a monthly basis, Vital Records forwarded lists of high-risk infants to the local health districts for follow-up through a nursing appraisal using Denver Developmental scoring; this effort ended in the early 1990s.

The 1993 National Institutes of Health UNHS joint consensus recommendation, and subsequent recommendations from other groups, spurred UNHS efforts in Georgia. In 1997, funds were identified to purchase newborn hearing screening equipment for 14 hospitals located primarily in three rural, south Georgia health districts where interest was expressed. In addition, Audx units were purchased in five other health districts and Babies Can't Wait (BCW, Part C of IDEA) early intervention nurses were trained in their use with high-risk infants and toddlers.

Current Status: In 1999, the General Assembly enacted H.B. 717 and appropriated $143,000 to carry out its key provisions. (See H.B. 717, Appendix C.) This bill is the impetus for current efforts in Georgia. Since then, two major grants have been awarded; funding from the Appalachian Regional Commission to purchase newborn hearing screening equipment for 19 north Georgia hospitals, and from MCHB for three core operational components - 1) statewide systems development, marketing, public and professional education, and overall management; 2) field implementation; and, 3) basic surveillance/evaluation. Moreover, the 2000 legislative session approved the Governor's request for $2.0 million in tobacco MSA funds to purchase equipment for the remaining Georgia hospitals with ?100 births per year, for local health departments to facilitate post-discharge screening, to support Medicaid incentives for newborn hearing screening, and reimburse audiological evaluations when no other payment source exists.

The work related to UNHS implementation, supported by these funds, is being done by the State Advisory Committee on Newborn Hearing Screening (SACNHS), a joint committee of the State Interagency Coordinating Council for Early Intervention (SICC, Part C of IDEA) and the Maternal and Infant Health Council (M & I Council) and assigned staff from the DPH Family Health Branch (FHB), where Title V and Part C responsibilities reside. The SACNHS is chaired by two pediatricians, representatives of the SICC and M & I Council. Members include audiologists, pediatricians, a hospital administrator, a representative of the Georgia Hospital Association, adults with HI, parents of children with HI, legislators, and an obstetrics nurse. (See membership, Appendix D.)

SACNHS work is guided by its three subcommittees: 1) guidelines, 2) public awareness/-education, and 3) data. The guidelines subcommittee is responsible for developing the plan to launch UNHS. Screening, clinical evaluation, and medical care and genetics guidelines, i.e., recommended protocols, for hospitals and providers were forwarded to DPH, in May 2000. (See guideline outline, Appendix E.) The public awareness/education subcommittee is moving forward with a plan to raise awareness of the value of early identification of HI and intervention options for infants with HI utilizing a mass media campaign, presentations to targeted groups, a toll-free hotline, a website, and distribution of promotional items, as well as overseeing plan-based training activities. A brochure has been developed and 200,000 copies are being printed for distribution to hospitals; a brochure and video detailing intervention options is being planned. In addition, a two-day seminar for audiologists in Fall 2000 and local level training for all system partners in each of the 19 health districts beginning in Summer 2000 are being organized. Training and technical support will be required from the equipment manufacturers as part of the statewide contract for screening equipment purchase. The data subcommittee is working on a uniform state database which incorporates standardized techniques, methodology, reporting, and system evaluation that will be integrated into other existing DPH structures.

At the same time, staff are involved in several other implementation-focused activities. Work is underway to purchase and distribute MSA- and ARC-funded screening equipment by October 1, 2000. Additionally, efforts continue with the Department of Community Health (DCH) to develop an incentive reimbursement system to encourage hospital UNHS that would target screening of 85% of all infants to qualify and address policy and procedural barriers for families covered by Medicaid, almost half of all Georgia births. Other areas being addressed are development of a post-discharge screening and payment mechanism for local health departments doing screening of missed births and follow-up of infants referred from the initial screen, and payment mechanisms for clinical evaluation and diagnostic examination of infants without other payment sources. Job development and recruitment for the two MCHB-funded positions, project coordinator and administrative assistant, is occurring.

Support from the Governor has been exemplary and can be counted on for the successful implementation of GEHDI. Since assuming office in January 1999, Governor Roy E. Barnes and his wife, Marie, have made a professional and personal commitment to UNHS, with Mrs. Barnes making the concern one of her focuses. (See HRSA support letter, Appendix F.) The Governor recommended use of MSA funds for UNHS and requested ARC funds be awarded for screening equipment purchase. He also wrote to every birthing hospital to endorse hearing screening and enclosed "Silence Isn't Always Golden" brochures from the NIDCD Information Clearinghouse for distribution.

II. Goals and Objectives

GEHDI goals mirror Healthy People 2010 hearing goals 28-11 and 28-13 and the MCHB milestones related to screening, follow-up, clinical assessment, and intervention. The GEHDI outcome goal is:

To enable children with hearing impairment to acquire communication skills within a defined typical range at age seven by early identification through newborn screening (by age one-month), clinical assessment (by age three-months), intervention (by age six-months), and on-going therapy and support services (as appropriate and requested by family).

This outcome goal is effectuated by program goals related to the establishment of the state GEHDI program, surveillance, and evaluation infrastructure; development of a local hospital/health department UNHS framework; implementation of screening, referral, clinical evaluation, intervention, and support linkages; and policy directions. These comprehensive system goals and related objectives were fully detailed in the MCHB grant application. (See MCHB GEHDI goal/objectives, Appendix G. N.B. Some modification has occurred in the course of implementation.) They provide an overall understanding of GEHDI and set the context for surveillance and tracking as related to the achievement of overall goals.

GEHDI surveillance and tracking goals coalesce in four areas: 1) assuring screening, diagnosis, and interventions by tracking individual infants/children; 2) describing and monitoring hearing loss in infants and children through surveillance; 3) improving unit level and system functioning with quality assurance to determine performance of reporting sources and exceptions that require follow-up; and 4) evaluating GEHDI to assess the impact of screening and early intervention on health status outcomes. Specific goals and objectives in each of these four areas are presented below.

Goal 1: Assure timely receipt of initial hearing screening and necessary post-discharge screening, follow-up and linkage services, diagnostic evaluation, and early intervention using a tracking system that identifies all newborns in Georgia.

Objectives -

To establish an electronic system that populates the tracking database with all Georgia newborns and provides in-hospital hearing screening data regarding these infants by August 2001, with a paper tracking system consisting of core data elements operational by January 2001.

To utilize the tracking system to assure that at least 90% of infants receive needed post-discharge hearing screening, clinical diagnosis, intervention, and family supports within the guideline-specified timeframes and, as necessary, provide referrals and linkages to facilitate receipt of needed services beginning January 2001.

To collect tracking data on receipt and result of post-discharge hearing screening, clinical diagnosis, intervention, and family supports, as appropriate based on findings, for at least 90% of infants referred from or not receiving in-hospital hearing screening beginning January 2001 and on-going.

To provide tracking data files to the state DPH office via hard copy beginning February 2001 and electronically beginning September 2001.

Goal 2: Systematically describe and monitor hearing loss in infants based on tracking system data and for other children through age six based on case reporting and registry matching.

Objectives -

To analyze and interpret GEHDI tracking data and case reports to produce regular and special reports for public health staff, the SACNHS, and funders that monitor and describe hearing loss in infants and children to inform policy decisions and resource allocation beginning July 2001 and on-going.

To evaluate surveillance system attributes, particularly simplicity, flexibility, and acceptability, to ascertain the usefulness and cost of the system and employ these findings to improve system functioning beginning July 2001.

Goal 3: Achieve GEHDI system operations benchmarks through quality assurance activities directed at measuring and improving the functioning of individual reporting units and the system as a whole.

Objectives -

To undertake regular review of data timeliness, completeness, and correctness to identify individual reporting sources not meeting system data standards as well as common problems experienced by multiple reporters beginning July 2001 and on-going.

To examine adherence to GEHDI guideline benchmarks regarding screening levels and provision of post-discharge screens, diagnostic evaluation, and intervention within set timeframes beginning July 2001 and on-going.

To develop and implement training and technical assistance, and individual consultation that address identified data and program quality assurance findings beginning July 2001 and on-going.

Goal 4: Determine the impact of GEHDI (infant hearing screening, follow-up and linkage services, diagnostic evaluation, and early intervention) on the health status outcomes of children with hearing loss.

Objectives -

To design an evaluation study to determine the impact of hearing screening and early intervention (by age six-months) on the acquisition of communication skills by children with hearing loss, within the typical age seven range, by September 2001.

To implement the evaluation based on the design and collect data throughout the remainder of the program period with preliminary analyses as appropriate. (Final analysis will not occur until beyond the five-year CDC project period due to the age seven end point.)

A. Target Region and Births

Georgia, the largest state east of the Mississippi River, is the country's tenth most populous state. The state is the seventh fastest growing in the U.S. and the fastest growing east of the Rocky Mountains. Children under age 18 comprise 1.7 million of the state's total population of 7.85 million (1999 Census estimate). Sixty-four percent of Georgia's children are white, 34% are African-American, 2% are Hispanic, and almost 1% are Asian. The Hispanic, Asian, and "other" population more than doubled between 1980 and 1990, and is projected to again triple by 2020. Fifty-one percent of children live in the 15 largest counties; the remainder are dispersed throughout the other 144 urban and rural counties.

Georgia is dominated by metropolitan Atlanta's 20-county area, where 43% of the state's population resides, however, rural areas with 37% of the population exert a strong influence in local and state politics. Fragmented into 159 counties, 117 of which are rural, Georgia's governmental structure is decentralized. Infrastructure development for health service delivery in many rural counties is impeded by small populations and weak economies. Community infrastructure throughout Georgia, formed during the earlier agrarian period, stresses traditional personal and family networks and informal community support, rather than formal organizational systems for service delivery.

In 2000, about 125,000 babies will be born in Georgia, a number that increases by about 3,000 births a year. In 1998, 63.9% of babies born were white, 33.6% were black, and 2.5% were other. These babies were born at 126 facilities ranging from Northside Hospital, in north Fulton County, the largest hospital birthing facility in the U.S., where over 15,000 babies are born annually, to many small community hospitals in rural areas where less than 100 births occur, and some non-birthing hospitals which have ten or fewer deliveries. Presently, 30 hospitals indicate they are conducting UNHS and another 23 are doing high-risk screening or screening based on doctor's orders. Last year, approximately 40,000 infants were screened through UNHS with another 3,000 screened based on risk or doctor's orders, resulting in screening approximately 40% of Georgia births. (See hospital summary, Appendix H.)

High-risk births are of particular concern in Georgia as the state ranks 41st highest nationally in low birthweight (LBW) infants, babies who are at increased risk for HI. (Kids Count, 2000) In 1998, 10,493 babies were born LBW, of which 20.9% (2190/10493) were very LBW (under 1500 grams). The racial disparity of these births is of note with the prevalence of LBW black babies (12.74/100 live births (5257/41274)) almost double that for white babies (6.44/100 live births (5036/78167)). The 1998 overall rate of very LBW babies was 1.8/100 live births and 3.0/100 live births among blacks.

B. Activities, Methods, Resources and Timeline

As indicated above, DPH has made significant progress in the implementation of its statewide UNHS system, GEHDI. However, the state infrastructure to support the system is relatively weak due to the vagaries of state funding which emphasize use of resources at the local level and the priority directions of both MCHB and ARC grants. Consequently, the tracking and surveillance components that form the engine of GEHDI and facilitate linkage among the other components are less fully developed at this time, both conceptually and operationally. The plan presented below describes the process in which DPH will engage to develop and implement these components as well as the key issues that will be addressed in the development phase. The tracking and surveillance components will be structured to meet four key objectives: 1) assuring screening, diagnosis, and receipt of interventions by tracking individual infants/children; 2) describing and monitoring hearing loss in infants and children through surveillance; 3) improving individual level and system functioning with quality assurance to determine performance of various reporting sources and exceptions that require follow-up; and 4) evaluating GEHDI to assess the impact of screening and early intervention on health status outcomes.

Tracking and surveillance system for screening, identification and intervention - Although tracking will function within an open system, with multiple reporters and access points, the Children 1^st referral, linkage, and tracking system in each of the 19 health districts will provide the backbone for linkage activities. Children 1^st provides a single entry point for infant and child public health services in each health district. For GEHDI, the basic Children 1^st identification system that relies on electronic birth certificate (EBC) download and health provider and service agency referral will be buttressed by a community plan that sets forth screening, evaluation, and intervention approaches and linkages specific to the locality. Initial identification of both children referred from the in-hospital screen and those not screened at birth will be accomplished by a weekly Vital Records EBC database download. The EBC has recently been modified to include two new variables: 1) hearing screen - yes/no, and 2) pass/refer. Programming is now being done to make data accessible at the local public health level.

Following EBC download, the district Children 1^st staff will assume the responsibility for identifying children requiring referral for follow-up, as well as those needing initial screens. Using EBC information, they will contact the families and, as appropriate, perform assurance activities to determine if post-discharge screening has occurred, offer to conduct the initial or post-discharge screen, and/or make necessary referrals and linkages for a full range of services, including diagnostic evaluation, family support, or intervention services. Open files will be created for all infants/children who are referred from the newborn screen or a provider referral for progressive/acquired HI. Children 1^st staff will enter data received from reporting sources (hospitals, physicians, audiologists, interventionists) into the local database. These data will be collected based on the specific community follow-up plan and/or from direct family contact to ascertain the status of follow-up and intervention. On a monthly basis, local tracking data will be uploaded to DPH for inclusion in the statewide GEHDI surveillance database.

With the basic tracking approach described above, the tasks to design the dual-function tracking and surveillance system and the attributes and elements that must be incorporated into this system become the next area for consideration. Preliminary work by the SACNHS and Family Health Branch (FHB), Maternal and Child Health Epidemiology (MCHE), Vital Records (VR), and Health Assessment Section (HAS) staff, all of whom will be extensively involved in development and implementation, has shaped directions to date. The preponderance of the work, however, is proposed for initiation through this proposal. While electronic database development occurs, the SACNHS data committee and DPH staff are developing an interim, paper tracking system with basic data elements.

The development framework starts with a blueprint of the major elements - tracking, surveillance, quality assurance, and evaluation. Using a joint application development (JAD) approach borrowed from information technology that brings together various parts of the organization to determine a plan that solves a specific issue, a DPH Data Policy Committee (DPC)-sponsored workgroup, with representation from the SACNHS, four relevant DPH units, and key system participants such as local health departments, hospitals, and health providers, will convene. An experienced systems developer will direct this effort. The initial task for this group is defining and describing the system objectives in relation to the policy decisions and control measures to be supported. With this information guiding further efforts, over a four-month period, two different tracks will be pursued: examining options for the structure/flow of the system, and defining the data elements within the system.

In undertaking the system flow analysis, all the data generation points, uses of the data, and persons needing the data will be identified and possible schema for data flow will be created. In addition to assessing resource requirements and cost, the analysis to select the ultimate approach will include consideration of basic surveillance system criteria: simplicity of structure and operation, flexibility to adapt to changing needs, acceptability to participants, sensitivity in terms of case detection, specificity related to identifying infants/children who have actual HI, accuracy over time and by varying reporting sources, and timeliness. Recommendations will be presented through the FHB, MCHE, and DPH DPC to DPH management for final determination.

Concurrently, another DPH DPC-sponsored workgroup will be formed (some participants will overlap the two groups) to delve into the technical aspects of database development and data elements. The systems developer will assure necessary crossover between the two workgroups on system structure and operation issues that may impact database and metadata (i.e., data dictionary) development and vice versa. The workgroup, also functioning in a JAD model, will define the data elements using the CDC National Database for Newborn Hearing Screening document as a guide for discussion and, following the standard template for DPH metadata development, detail data specifications including names, DPH standards for each element, unit and level of measurement, and unit and level of analysis. This will culminate in the development of a data dictionary that will be used to construct the database, develop forms, and undertake necessary state and local level programming. Decisions from both workgroups will inform technical aspects of database construction, e.g., distributed versus central repository application, selection of database software application, access to and/or types of data portals, etc.

In the next phase, taking about three months, the actual system that models the tracking and surveillance system will be built based on the data supplied by the workgroups. GEHDI data elements will be incorporated into the existing clinical record and tracking systems, already used by the local health departments, in a manner that will enable surveillance data to be uploaded to the state office. The systems developer will work closely with relevant public health staff in interpreting the model that has been established and creating the computer code language so that the database is organized to give the requisite output to meet the four system functionalities. During this phase, alpha testing of individual components will be done, followed by in-house beta testing employing "fake" data. Documentation will be created to support long-term system maintenance. The systems developer will work closely with the two sets of end-users -- the local level trackers and the state epidemiologist who will be doing data analysis, quality assurance, and evaluation - to ensure that the computer model meets in-vivo demands.

Full-scale beta testing in the field will then occur over two months. Extensive "bug lists" will be generated and necessary "fixes" will be made. During the month following beta testing, the 1.0 version will be finalized and distributed along with use manuals. In-depth, on-site training will be provided for end-user trackers, and relevant training material will be produced for reporters, including, if web-based entry is a selected data portal, on-line help. Following initial training, on-going technical support will be available from the state office. Based on this schedule, full field implementation will begin in Month 11. At the conclusion of the development period, the more advanced skills of the developer may not be required and a person with less development experience who is able to administer the database on an on-going basis will be sought.

An experienced master's level or doctoral-trained epidemiologist will be employed to generate standard state reports that include incidence, prevalence, and quality assurance, as well as required CDC data and program reports. The epidemiologist will follow-up on quality assurance issues through the program coordinator to resolve identified problems. The MCHB-funded project assistant will support data tasks such as editing. Data may also generate future special studies, such as risk factor and outcome analyses, which will be conducted by the epidemiologist, with support from MCHE and HAS. Findings from these analyses will be shared with relevant staff and the SACNHS. The use of data for evaluation is more fully described in Section IV, below.

A surveillance system flow chart can be found in Appendix I. A tracking and surveillance system development and implementation timeline appears in Appendix J.

Collection of standardized data - An overview of the tracking system is provided above. As indicated, the data dictionary, with standardized data elements, will serve as the framework for data collection. This dictionary, created by the DPH DPC, will incorporate CDC's minimum requirements into the GEHDI metadata development template.

Inclusion of late onset/progressive hearing loss- In Year 2, efforts will be taken to extend the tracking system to include children with late on-set and progressive HI. Two approaches will be used to identify these children: case reports from ENTs and audiologists regarding children under treatment, and existing Georgia surveillance systems for conditions such as traumatic brain injury (TBI), meningitis, congenital rubella syndrome, measles, and mumps that are risk factors for HI. The TBI registry provides disability information and can be used to identify specific cases that can be matched against GEHDI reporting to find missing cases, while the infectious disease surveillance systems can identify children at elevated risk on whom individual follow-up might be done. Although too early to be specific, case reports from ENTs and audiologists are likely to be directed to the local Children 1^st staff for inclusion in the GEHDI tracking system. State DPH office will do initial case finding using the TBI and other surveillance systems and refer these "suspect" names to Children 1^st for follow-up.

Obtaining outcome data - When a child receives DPH services such as BCW and CMS, tracking and obtaining service and outcome data should not be problem as this administrative data is available, internally. Parental release may, however, be required to merge this data into the GEHDI tracking system. For children not receiving DPH services, information from primary care physicians, ENTs and audiologists will be essential to complete diagnostic and treatment-related data fields. Moreover, school assessment data related to communication skills will be required for impact evaluation. Clearly, collaborative approaches to engage these external players are needed and will be emphasized as system development proceeds. Inroads already exist through relationships described in Section V, Collaboration, below, and as indicated in the letters of support for this grant as well as the HRSA grant. (Appendix F.)

Concerns from parents/professionals - Based on the implementation surveys now being completed, two primary areas of concern affecting surveillance and tracking have been evidenced: the burden of data collection and reporting, and information sharing with public health. Focused attention is being given to these concerns. In addition, as part of program evaluation, satisfaction data will be obtained from both parents and professionals. Besides program-level assessment of concerns, the SACNHS, which has both parent and professional representation, will review this information and make recommendations.

Collaboration with other state programs - Section V below details both internal collaboration within DPH, as well as external collaboration with other state and local agencies and organizations. The GEHDI structure is premised on an integrated rather than stand-alone approach in which UNHS is built-in to existing programs and systems.

Integration with other screening programs - Children 1^st provides the framework for integration with other screening programs using EBC data, as well as medical and service provider referrals to identify infants and children through age five at risk due to medical, environmental, or social conditions. As the gateway for public health services, Children 1^st staff assure follow-up for critical medical conditions identified by various screening programs, such as newborn metabolic and hemoglobinopathy, and lead poisoning. MCHE has successfully piloted use of Automatch to link infants screened for metabolic conditions with those screened for HI. Using this approach, DPH should be able to integrate data from various screening programs for surveillance purposes.

Documentation/dissemination - Careful written documentation is requisite to the development of both the tracking and surveillance system. The basis for tracking documentation will be the guidelines for screening, clinical evaluation, and medical intervention now being finalized. Manuals and training materials will offer additional documentation for local Children 1^st staff. As indicated above, extensive documentation of the tracking and surveillance database will be available through the data dictionary and computer system development documentation file. All such materials will be available to other sites and interested parties. Reports published related to findings and recommendations will be widely distributed and, as appropriate, articles will be prepared for publication in newsletters and journals. In addition, opportunities will be sought to make presentations at relevant meetings and conferences.

IV. Evaluation Plan

GEHDI evaluation requires inclusion of formative, process, and summative information. Any system change evaluation must encompass attention to the building blocks of the system, as well as the various techniques of putting those blocks together to create a meaningful structure. The purpose of GEHDI and its effects on the target population can only be fully understood with a strong understanding of its building blocks and their structure. This plan provides an initial framework for the GEHDI evaluation, with a complete evaluation plan and accompanying instruments to be developed by the end of Project Year 1.

Evaluation Management: The SACNHS will act as the steering committee for the evaluation process and assist in the interpretation and appropriate dissemination of findings, while the GEHDI management team will be fully engaged in reviewing questions and data collection methods. The FHB data manager, GEHDI epidemiologist, and GEHDI project coordinator, with the assistance of an evaluation consultant, will be responsible for the implementation of the evaluation plan.

Evaluation Questions: The core evaluation question for this system is, does the system effectively identify children with hearing impairment and assure access to needed services for the purpose of improving their communication skills? Other more specific evaluation questions relate directly to each of the four primary goal areas and their associated objectives. Special attention will be paid to the issues of timeliness, completeness, effectiveness, and efficiency with the CDC Guidelines for Evaluating Surveillance Systems monograph providing a framework for assessment of surveillance activities. Additional evaluation questions may arise out of the SACNHS or other partners. The impact evaluation question is, do infants identified and served through GEHDI evidence typical communication skills at age seven?

Data Collection Methods: System measurement requires qualitative and quantitative data. The following data collection activities and methods will provide the foundation for the evaluation, however, additional methods may be developed, as needed, to ensure appropriateness and usefulness of these data.

Initial inventory of GEHDI components will provide the baseline measuring progress in system implementation.

Monthly reports will be created from the GEHDI surveillance system to document prevalence of diagnosed HI, geographical spread, completeness of screening, incidence of failed screenings, and appropriate referrals. These data will allow for both state aggregation and mapping which can provide a portrait of HI in Georgia, as well as identify potential hot spots .

Tracking the progress of children identified with HI will occur through periodic Children 1^st reporting. These data will examine on-going follow-up and appropriate referrals, as well as identify potential service gaps in specific areas.

V. Collaborative Efforts

The service and support network required by an infant who is referred from newborn hearing screening has several elements. Key network elements for referred infants are audiologists to perform evaluations, make diagnoses, and if required, fit hearing aids; physicians to address medical conditions and provide medical clearance for hearing aid fitting; local public health agencies to offer follow-up and referral through Children 1^st, and service coordination, intervention, and treatment services for eligible infants through BCW and CMS; private agencies and speech-language and other therapists to assist infants with HI and their families by providing habilitation and support services; and family support organizations to help families deal with practical and emotional issues attendant to an infant with HI.

Several agencies and programs provide services to infants and children with HI. Within public health, as previously mentioned, both BCW and CMS address the needs of these children. BCW does not have income eligibility, but is limited to children up to age three with severe bilateral hearing loss and, depending on the Individual Family Service Plan (IFSP), may provide speech-language and other therapy, hearing aids, and family support services. CMS provides medical treatment including surgery, drugs, and assistive devices including hearing aids to income-eligible infants and children up to age 21 with diagnosed HI and otological conditions. In some cases, a combined BCW and CMS services are used to address the needs of a child. Georgia Medicaid is responsible for the incentive reimbursement system to encourage UNHS and, under a newly revised policy, covers the clinical evaluation of enrolled children, and analog hearing aids. In addition, several specialized agencies serve the needs of infants and children with HI. Georgia PINES, a statewide program of the Georgia Department of Education, provides assistance to children, birth to age five, in obtaining a full range of assessment related to sensory disorders and family support services through state schools and private local providers. Georgia PINES currently serves 125 children. Georgia operates three schools for the deaf - two residential schools (Georgia School for the Deaf, in Cave Springs and Georgia School for the Deaf-Blind, in Macon) and one day school (Atlanta Area School for the Deaf). In addition, services for children with HI are available through Part B of IDEA programs in public schools throughout the state and a few private schools in the Atlanta area. The Georgia Speech-Language and Hearing Association serves health professionals in relevant disciplines; it conducts conferences, publishes a newsletter, and undertakes advocacy. Presently, the national, HI focused, voluntary organizations do not have Georgia chapters. However, Parent-to-Parent and Family Voices, two national groups for parents of children with disabilities, offer family support, referral and advocacy services in Georgia.

GEHDI building blocks form a UNHS infrastructure at the state and local levels using established public health systems, including Children 1^st and regional tertiary perinatal centers; on-going public health programs, such as BCW and CMS; and existing, broad-based advisory groups including SACNHS, State and local Interagency Coordinating Councils (ICC), and the M & I Council. Already incorporated into these systems, programs, and advisory bodies are most of the key relationships necessary to implement GEHDI. Within the Family Health Branch, GEHDI is being integrated into the current population-based system that interlocks infant and child health, children with special needs, and maternal health using current structures rather than creating a stand-alone program. GEHDI draws upon other DPH units, such as Vital Records, MCH Epidemiology, and Health Assessment to support the underlying tracking and surveillance system. This infrastructure is linked to local public health operating systems, including Children 1^st and regional perinatal planning, merging GEHDI activities into on-going infant tracking and referral systems and service programs, such as county health department child health clinics, BCW, and CMS, to provide requisite service coordination and care.

At the state level, relationships, along with coordination and collaboration around the set of activities involved in GEHDI, have already been forged and exist, both formally and informally, through contracts and participation on advisory groups. For example, FHB contracts with the Georgia Chapter of the American Academy of Pediatrics to encourage pediatricians to refer to Children 1^st, and with regional tertiary perinatal centers for care and follow-up of high-risk infants; BCW contracts with Parent-to-Parent for family resource linkages; and CMS has an extensive network of specialty health providers. In addition, the key advisory groups for GEHDI - SACNHS, State ICC, and M & I Council - include representatives of relevant state agencies (Medicaid, Education, Mental Health/Retardation, Insurance, and Children and Family Services); physician and nursing groups; the Georgia Hospital Association; practicing audiologists, obstetric nurses, neonatologists, and developmental pediatricians; hospital administrators; family representatives; and legislators. A similar pattern is reflected on the local level through less formal, on-going, working relationships, formal contracts and committee participation. Of particular note are CMS and BCW service agreements with local providers, Children 1^st referral networks, and local ICCs in each health district that bring together agencies, providers, and families.

VI. Staffing and Management

GEHDI activities cross numerous DPH units necessitating the development of a shared management structure. Direction and supervision of the GEHDI program coordinator (MCHB-funded) will be the responsibility of FHB Infant and Child Health (ICH) Office Director, Malissa Abdulla, M.S.S.W. The program coordinator will lead the project workteam whose core members will include the systems developer and epidemiologist (funded through this grant) with other staff engaged on an as-needed basis. (See job descriptions, Appendix B) To give requisite professional supervision, the systems developer will be supervised by Terry Lofton, M.P.H., Director, Health Assessment Section, and the epidemiologist by Paul Blake, M.D., M.P.H., Director, Epidemiology. In addition, to coordinate GEHDI tracking and surveillance activities, a division management team will be formed to address inter-unit issues (Eve Bogan, M.A., Director, FHB Program and Services Section; Elana Morris, M.P.H., Director, FHB Health Data Team; Michael Lavoie, Director, Vital Records; and Ms. Lofton and Dr. Blake). (See CVs, Appendix B and GEHDI table of organization, Appendix I).

At the state level, GEHDI will have three operational components: management and statewide activities, field implementation/tracking, and surveillance/evaluation. The GEHDI project coordinator will be directly responsible for the first component and will work closely with other FHB units charged with the remaining two responsibilities. Field implementation will be supported by the infant and child health consultants, reporting to Ms. Abdulla, that provide technical assistance and consultation to district and county health offices and providers in the implementation of public health programs. Mr. Roche will serve as the audiological specialist for this team. Once systems development is completed, data management, surveillance and evaluation activities will be carried out by MCHE, under Dr. Blake's supervision. Assistance will be provided by Rebekah Hudgins, M.P.H., the ICH/CSN evaluation consultant. Elana Morris, M.P.H., manages all FHB data activities.

Experience with activities and necessary skills required for GEHDI implementation exist at the state and local levels. Children 1^st has been operational for over three years and local public health staff are well-versed in EBC download as well as follow-up with families and health providers regarding infants with EBC-identified risk factors. The Epi unit is comprised of physician and doctoral trained epidemiologists, several of whom have been EIS officers, as well as master's level analytic staff and computer programming and database management personnel. All standard epidemiologic methods are employed by these staff who are responsible for carrying out the full range of public health surveillance activities in Georgia. The MCH Epi staff has access to all vital records files and uses them to link with program files, undertake a wide range of analyses, and produce reports. Staff has on-going responsibility for statewide disease reporting and investigations and provide extensive formal training and support to local public health staff and hospital and physician reporters.

VII. Organizational Structure and Facilities

The DPH, the state public health agency, is part of the Department of Human Resources. With a central office in Atlanta, DPH has several units, including the FHB which has primary responsibility for UNHS, the HAS with data warehousing and planning functions; MCHE which conducts data analysis and public health investigations, and VR which is the official state birth and death registrar. The FHB is the state Title V MCH block grant recipient and administers the CMS and BCW programs. Georgia is divided into 19 public health districts encompassing 159 counties. Each district, with 1 to 16 counties based on population size, provides county health departments with programmatic and administrative support. (See DPH and GEHDI tables of organization, Appendix I.)

All DPH staff have computer workstations with web, and local and wide area network connectivity. Epi staff have PC desktop units with sufficient memory and speed to handle large data files. In addition to standard office productivity applications that all DPH staff access, Epi staff have SAS capacity through DPH's network license. The Health Assessment Section is now developing warehouse functionality for all DPH data and has purchased an Oracle metaengine as the primary technical ware. District public health staff have continuous web connectivity and are connected to both county health departments and the state DPH office through the Georgia Department of Administrative Services router system. All public health networks have additional firewall security.

VIII. Human Subjects Requirements

The Division of Public Health operates under the Georgia Department of Human Resources' (DHR) multiple project assurance. Tracking and basic surveillance activities are exempt from Institutional Review Board (IRB) involvement as their intent is not research. However, formal permission for release of data will be obtained, as necessary, for information sharing among involved parties. Program evaluation that examines tracking and surveillance in order to improve those activities is exempt as non-research. Any evaluation proposed to test the efficacy of UNHS in improving health status outcome is research and, as such, will be submitted to the IRB for approval, at the appropriate time, and conducted in accordance with federal and DHR IRB policies.

IX. Budget

A complete line item budget and budget justification appears before the narrative, following the order specified in the program announcement.