WISCONSIN'S CDC EHDI GRANT (2001)

GRANT ABSTRACT

Grant Program: Cooperative Agreement for Early Hearing Detection and Intervention (EHDI) Tracking, Research, and Integration
Project Title: The Wisconsin EHDI - Tracking, Referral and Coordination (WE-TRAC) Project Level 1 - CFDA #93.283
Grantee Organization: Wisconsin Department of Health and Family Services, Division of Public Health, CSHCN Program
Address: One West Wilson Street
P.O. Box 2659
Madison, WI 53701-2659
Project Director: Sharon Fleischfresser, M.D., M.P.H. Phone: 608 266-3674
Grant Period: Up to 4 years - Cycle 1: 8/01/01 to 7/31/01

B. Purpose: The purpose of the WE-TRAC Project is to establish and implement an integrated electronic EHDI data tracking and surveillance system. This goal supports the vision of the WSB Program and the recommendations of the Joint Committee on Infant Hearing (JCIH) 2000 position statement that all infants with hearing loss are diagnosed by three months of age and reach intervention services by six months of age.

C. Problem: Establishment of universal newborn hearing screening (UNHS) programs at Wisconsin hospitals has been voluntary. In October 1999, the Wisconsin legislature passed Act 9 s.253.115 which states that if by August 5, 2003 less than 88% of deliveries in Wisconsin are performed in hospitals that have a newborn hearing screening program, each birthing hospital will be required to implement UNHS by January 1, 2004. However, no funding was allocated to the development of a data system as part of the legislation. No centralized data collection and tracking system exists. Since 2000, birthing hospitals are surveyed annually to gather information related to the number of infants screened and screening practices. While the number of hospitals with UNHS programs has increased from two in 1997 to 54 in 2000, it is estimated that only approximately half of all infants were screened in 2000. Consistent with the Healthy People 2010 objective, Title V performance benchmarks, and Wisconsin legislation, a data tracking and surveillance system needs to be in place to monitor progress and to assure that hearing loss is diagnosed and intervention services received. In order to assure that Wisconsin meets these criteria, the development of the WE-TRAC system is essential.

D. Objectives: Objectives of this project are:

• Establish and implement an electronic EHDI tracking and surveillance system called WE-TRAC
• Integrate the WE-TRAC system with other newborn data systems
• Establish reporting and tracking mechanisms to assure minimal loss to follow up and to enhance communication among parents and providers regarding follow up activities.
• Collect, analyze and report critical outcome data including hospital screening performance reports and performance benchmarks.

E. Methodology: The methods used to accomplish these objectives will include purchasing of information technology expertise to plan, design and develop, integrate and test, and implement the WE-TRAC information system. The system will collect standard data on infants and children with late onset or progressive hearing loss from multiple reporting sources. The centralized database will be populated with hearing screening results from the birth record and linked to the newborn metabolic screening program. Integration with other public health data systems will be explored. Working closing with its collaborative partners, mechanisms will be put in place for tracking and follow-up including the support of web based reporting and messaging. Information gathered from WE-TRAC will be analyzed to monitor Wisconsin's progress to establish a tracking and surveillance system.

F. Evaluation: Specific evaluation criteria have been appropriated for each objective of the grant. This will allow the WSB Program Coordinator, Co-Principal Investigators, and the IT Project Manager checkpoints to assure efficiency, effectiveness, timeliness and quality of work. Regular meetings will be established with the Principle Investigators, WSB Program Coordinator and IT- Project Manager to closely monitor progress. The IT- Project Manager will become a member of the established WSB Program management team and regularly attend meetings to assure coordination with other WSB Program activities. Semi-annual progress reports will be made to the CDC. Reports provided by the EDHI data tracking and surveillance system will be analyzed to monitor Wisconsin's progress toward meeting established JCIH performance benchmarks.

GRANT NARRATIVE

I. Understanding the Problem and Current Status

A) Understanding of the requirements and purpose of the cooperative agreement.

Hearing loss is one of the most common congenital disorders found in newborns. It affects approximately 1 in 300 births, or over 200 children in Wisconsin every year. If left undetected hearing loss can severely affect the child's speech, language, cognitive, social and emotional development. Studies indicate that early identification of hearing loss in children greatly increases their chances of normal development. However, reliance on physician or parental recognition of hearing loss during an infant's first year has not been successful. Screening with high-risk guidelines alone results in identifying only 50% of newborns with significant hearing loss¹. Therefore, the implementation of universal newborn hearing screening (UNHS) is essential. Wisconsin supports the Healthy People 2010 objective to "increase the proportion of newborns who are screened for hearing loss by age 1 month, have audiologic evaluation by age 3 months, and are enrolled in appropriate intervention services by age 6 months"².

Nevertheless, it is recognized that identifying the hearing loss is not enough to ensure normal development. Research has demonstrated that children must be enrolled in intervention services within the first six months of life in order to optimize the potential for achievement of normal speech and language development³. The Joint Committee on Infant Hearing (JCIH) 2000 position statement recommends that infants receive diagnostic services by three months of age and intervention services by six months of age⁴. It is recognized that in order to ensure timely referral to the indicated services a clearly defined protocol must be implemented, and comprehensive systems of care must be developed.

Establishment of UNHS programs at Wisconsin hospitals has been voluntary. In October 1999, the Wisconsin legislature passed Act 9 s.253.115 (Attachment A) which requires the Department of Health and Family Services (DHFS) to report to the legislature and, "if by August 5, 2003 less than 88% of deliveries in Wisconsin are performed in hospitals that have a newborn hearing screening program, each birthing hospital will be required to implement UNHS by January 1, 2004". However, no funding was allocated. The critical portion of assessing the effectiveness of programs and tracking babies to ensure that they receive appropriate diagnostic and early intervention Part C services has not been addressed.

The Children with Special Health Care Needs (CSHCN) Program located in the Bureau of Family and Community Health (BFCH), Division of Public Health (DPH), DHFS, coordinates efforts to promote the statewide implementation of UNHS.

In March 2000, the CSHCN program received a federal Maternal Child Health Bureau (MCHB) grant called "Wisconsin Sound Beginnings" (WSB) to support the implementation of UNHS in Wisconsin. Grant funds are used primarily to employ an audiologist as the WSB Program Coordinator. In addition, grant dollars are provided to the Wisconsin Personnel Development Project (WPDP) at the University of Wisconsin - Waisman Center to provide training and technical assistance for local Birth to 3 providers and to support regional hearing intervention expert technical assistance. MCHB grant dollars were not designated for the development of a data and tracking system.

The "Cooperative Agreement for Early Hearing Detection and Intervention (EHDI) Tracking, Research, and Integration" will provide Wisconsin the opportunity as a Level I applicant to achieve its goal to develop and implement an integrated electronic EHDI data tracking and surveillance system called WE-TRAC (Wisconsin EHDI-Tracking, Referral and Coordination).

B) Challenges, barriers and problems associated with developing and implementing an EHDI tracking and surveillance system.

Through a series of regional forums conducted in 2000 and from surveys of birthing hospitals, the following issues have been identified by hospitals: a lack of resources for screening equipment and staffing especially in rural hospitals with few births; assuring communication to the infant's provider or "medical home"; difficulty in maintaining a data management system for quality improvement; and implementing a follow-up protocol for infants who fail. Parents identified a need for family-centered and culturally-competent education materials and access to services.

Comprehensive audiologic and medical evaluations are required to manage the infant when a hearing loss is suspected and confirmed. Barriers identified include: lack of skilled pediatric audiologists throughout the state; lack of physician knowledge of hearing issues; and lack of resources to support appropriate evaluations. These challenges are similar to those experienced by Birth to 3 programs: lack of skilled hearing intervention services in all areas of the state and inadequate funding for early intervention services. Issues related to confidentiality and data sharing will also need to be addressed.

Wisconsin currently does not have a mechanism to collect data and track infants as part of its WSB program. Developing WE-TRAC, a statewide EHDI data tracking and surveillance system, will assist Wisconsin's efforts to assure that infants receive timely and appropriate follow-up services.

C) Target Population and Current Status.

The target population for this grant is the approximately 68,000 births, which occur in 101 birthing hospitals across the state each year. Sixty-three percent of the birthing hospitals have 500 births or less each year. There are 21 birthing hospitals with less than 100 births per year. The number of rural hospitals with few births poses a particular challenge to UNHS implementation. An analysis of factors associated with Wisconsin hospitals having or not having UNHS programs found that the likelihood of establishing a UNHS program increased by 21% with each additional 100 births. In the last year the WSB program established a UNHS contact at each hospital. The Wisconsin Perinatal Foundation has set aside funds that will be used in 2001 to provide hospitals with matching grants for the purchase of screening equipment. These grants target small hospitals (50-150 births per year) that have not yet begun a UNHS program.

In addition, over 800 babies in Wisconsin are born at home each year⁵. The WSB Program Coordinator has obtained private funding to pilot UNHS screening by midwives in areas of the state with a high incidence of home births. Included in the proposed pilot is a mechanism for a paper reporting system of screening results.

Since 2000, the number of babies screened, the number referred, and hearing screening practices are annually surveyed by the Medical College of Wisconsin (MCW) in collaboration with the Wisconsin Association for Perinatal Care (WAPC), Wisconsin Health and Hospital Association (WHA) and CSHCN program. Between 1997 and 1999, the number of Wisconsin hospitals with UNHS programs increased from two to 33. During that same time period, the estimated percent of Wisconsin newborns screened for hearing increased from 10% to 31%. Approximately 2.6% of universally screened newborns had a failed screen.

Preliminary survey results (Attachment B) for year 2000 births from 67 of 101 hospitals indicate 54 hospitals have established UNHS programs resulting in screening 71% of infants born in those hospitals and nearly half of all Wisconsin births. Nine more hospitals have indicated plans to implement UNHS programs in 2001 or 2002. The percent of newborns with a failed screen at time of discharge was 2.5%. Currently, 60% of the hospitals with UNHS programs reported using auditory brainstem response (ABR) technology, 26% are using distortion product otoacoustic emissions (DPOAE), and 7% are utilizing transient evoked otoacoustic emissions (TEOAE). Hospitals reported using the following type(s) of data management systems: manual (40%), Natus Databook (38%), PC-Log (21%), and/or a site specific system (12%). Less than half of hospitals had mechanisms in place to track that infants identified with a failed screen were seen in follow-up by an audiologist and referred for intervention services.

Referral to an audiologist occurs either by the hospital UNHS program or by the primary care provider. There is no standard mechanism to assure referral and follow-up occurs. Currently there is not a reporting mechanism used by audiologists.

Local Birth to 3 programs are administered at the county level (72 counties) with oversight by the state Birth to 3 Program located in the Division of Supportive Living (DSL). Each local Birth to 3 program reports the number of children who receive services in the Human Services Report System (HSRS). As of March 2001, HSRS reported 76 hearing impaired children were receiving intervention services at that point in time. This is thought to be an under representation of the actual number of children served. Multiple client characteristics, while allowed, are not required to be reported. For example, a child with a developmental delay and hearing loss may be entered into the system as developmental delay only.

As part of the WSB grant, a multi-disciplinary UNHS Implementation Work Group (Attachment C) comprised of almost 30 members, was established to act as the advisory committee. This group, which meets quarterly, is comprised of parents, pediatricians, audiologists, geneticists, Birth to 3 providers, and many other disciplines. The UNHS Implementation Work Group developed a comprehensive program model (Attachment D) that outlines the components of screening, diagnosis and intervention. This framework exemplifies how the system must work starting with the birth to intervention. Regional forums outlining this framework were conducted throughout the state in 2000 to promote and emphasize the importance of follow-up and tracking.

Subcommittees have also been established to address issues of funding, legislation, "best practice" as it relates to diagnosis and medical evaluation, and data collection and tracking. In collaboration with the state Birth to 3 Program, a work group is developing early intervention guidance. Some accomplishments include a WSB brochure, draft educational materials for families and providers related to audiologic assessment and medical evaluation, a series of educational programs for Birth to 3 providers regarding intervention services for infants diagnosed with hearing loss, and currently a survey of Wisconsin audiologists (Attachment E). This survey will provide a picture of the availability of pediatric audiology services and help to determine the need and desire for training by audiologists. The survey will determine current data and tracking practices of audiologists as well. Once the survey results are tabulated, a list of "pediatric audiologists" will be distributed to screening hospitals, and primary care providers and posted on WAPC website.

D) Description of current EHDI tracking and surveillance system.

While a statewide tracking and surveillance system does not exist, much work has been done to lay the groundwork for development of such a system. A subcommittee of the UNHS Implementation Work Group was convened to consider tracking and surveillance issues. Like the Implementation Work Group, this subcommittee has representation of parents and potential reporting sources but also includes representation from existing state data systems such as Vital Records and the Newborn Blood Screening Program located at the State Lab of Hygiene (SLH).

From initial subcommittee discussions, a collaborative effort with other potential data sources appeared essential. In the last year, discussions were initiated with the State Registrar in the Bureau of Health Information (BHI), Vital Records Section. Currently approximately 85% of births are submitted to vital records electronically using a system called PC-Log. While hearing screening fields were added to PC-Log in 2000, few hospitals have used them. PC-Log is a DOS-based application, without a graphical user interface (GUI), which relies on modems, and has report writing capabilities that are difficult to use. However, a complete conversion of PC-Log to an Oracle based, electronic birth record submission is scheduled to occur by January of 2003, at which time PC-Log will be systematically phased out.

With the 2003 revision of the Wisconsin birth record, an agreement was reached with BHI to include newborn hearing screening results, modeled after Colorado's fields, as required data along with a newborn screening blood spot identification number to the revised birth record. The addition of the newborn screening blood spot identification number will facilitate the linkage of the birth record to the newborn screening blood spot. The birth record will serve as the first system to populate the proposed WE-TRAC database. The link via the newborn screening blood spot identifier could provide the foundation on which to build subsequent web-based data and tracking system.

The data and tracking subcommittee has begun to develop a tracking "flowchart" that depicts information flow. It is understood that this "flowchart" may shift or change as the data and tracking method to be implemented becomes better defined. However, the infant's primary care doctor or "medical home" along with the family has been established as central to the information flow. Each should receive information or reports at each stage of the process: screening, diagnosis and intervention. In addition, work has begun to identify necessary data elements to be collected to assure timely follow-up based on the experience of the Newborn Blood Screening Program.

Newborn hearing screening is only beneficial for infants with hearing loss if they receive appropriate audiologic services in a timely manner. Getting babies referred from screening programs to receive audiology follow-up services has been a difficult issue for existing UNHS programs. The Wisconsin Speech Language Pathology and Audiology Association (WSHA) is developing a Confirmation of Hearing Loss Report form (Attachment F) with uniform data collection elements. This has been a significant step to begin data collection by audiologists. With parental consent, the audiologist's report will be shared with the WSB program, primary care physician, and other professionals within the child's medical home. This would serve as a reporting mechanism for infants identified as part of UNHS but also for children with late onset or progressive hearing loss. It is envisioned that this paper form will become web-based.

The CSHCN Program administers Regional CSHCN Centers in each of the DPH Regions. These Centers provide: information and referral services for families and providers in conjunction with the centralized CSHCN/Birth to 3 toll-free 24-hour hotline and website called First Step; parent-to-parent support including a network of parent consultants in each county; and local service coordination through a contract with local health departments or other local agencies. These Centers assist families to find necessary services and support including referrals to the county Birth to 3 Program. While Centers and local health departments enter data into an MCH data system when providing service coordination, this data is not currently integrated with other data systems.

E) Other relevant tracking and surveillance activities.

Several important data initiatives have begun within DHFS. It is the intention of the WSB program to interface with and build upon these data initiatives:

The Wisconsin Public Health Data Steering Committee (WPHDSC) has developed the need and vision for the required linked information system and defined a comprehensive public health data system. The report summarizes the recommendations to develop and implement a public health integrated information system (Attachment G). Within the report is an inventory of the existing health care databases.

Turning Point is a statewide initiative to transform and define Wisconsin's public health system. Among the system priorities identified by Turning Point is an integrated electronic information system so that public health partners can effectively monitor and act on health issues.

Genetics Planning Grant is a MCHB funded project ending August 2001. The two goals of the grant are to develop a State Genetics Services Plan and to evaluate the flow of information through two points of identification of children with special heath care needs. The final report will present a plan for developing an informatics infrastructure, working toward a child health profile.

Perinatal Data Committee, coordinated by WAPC with broad statewide membership, is promoting a position statement that defines the criteria for a system of perinatal data collection, analysis and linkage (Attachment H).

Wisconsin Immunization Registry (WIR) is piloting a statewide immunization registry. The central registry includes all birth records since 1998. Local public health and private providers will directly access the central registry via the Internet/or telephone modem.

Wisconsin Birth Defects Prevention and Surveillance System is in the development phase. Recently, the DHFS Secretary appointed an Advisory Council to make recommendations to the department and provide guidance to the administrative rule making process. The Council will be identifying the birth defects to be monitored and the reporting mechanism to use. A formal report is due to the Wisconsin legislature in April 2003.

Health Alert Network (HAN) is a CDC funded nationwide system for communication and information access, distance-based learning, and organizational development designed to support the public health response to bioterrorism and all other public health threats. The long-term goal of the project is real-time integration of continuous health care data streams for surveillance, epidemiological evaluation and response. This project is helping to create a public health infrastructure by: (1) Assuring all local public health departments have dedicated high speed (T1) connections to the Web, (2) Creating a secure web site and alert messaging system, and (3) Creating a web-based distance learning capacity.

The University of Wisconsin Division of Information Technology (UW-DoIT) is contracted to develop and implement the HAN system.

The National Electronic Disease Surveillance System (NEDSS), is also a CDC funded project that is collaborating with UW-DoIT for development and implementation. The goal of NEDSS is to assure essential public health capabilities by: (1) Eliminating data silos by specifying a common data model for public health, (2) Creating a secure, web-based method for integrating all public health and surveillance and information systems, and (3) Creating an integrated data repository which will include the communicable disease database and the SLH's database.

HAN and NEDSS will provide components of the infrastructure needed to develop the EHDI tracking and surveillance system.

Robert Wood Johnson Data Integration Implementation Project is working closely with the HAN and NEDSS to look at information flow as our data systems are integrated. The goal of the project is to determine how public health can maximize information assets to automate and support business activities at the state and local levels.

II. Goals and Objectives

The goal of the WE-TRAC Project is to develop and implement an integrated electronic EHDI data tracking and surveillance system. This goal supports the vision of the WSB Program that all infants with hearing loss are diagnosed by three months of age and reach intervention services by six months of age. Objectives of this project are: (1) Plan, design and develop, integrate and test, implement and maintain the WE-TRAC system. The system will collect standard data on infants and children with late onset or progressive hearing loss from multiple reporting sources. (2) Integrate WE-TRAC data with other newborn data systems. (3) Establish reporting and tracking mechanisms to assure minimal loss to follow-up and to enhance communication among parents and providers regarding follow-up activities. (4) Collect, analyze and report critical outcome data including hospital screening performance reports and performance benchmarks as outlined in the Joint Committee on Infant Hearing Statement (June 2000).

Specific activities for each objective and their timelines for achievement are outlined in the Project Activities Time Allocation Table (Appendix 1). The DHFS meets the CDC requirement of inclusion of women, ethnic and racial groups in this project.

The WSB program model (Attachment D) depicts each component to be included in the EHDI tracking and surveillance system. This model, established by the UNHS Implementation Work Group, is based on a public-private partnership using the Newborn Blood Screening Program prototype and the Joint Committee's Infant Hearing performance benchmarks.

When a baby is born in the hospital and the hearing results are placed on the birth record, it is from this birth record that babies who fail screening (refer) will be identified. The birth record will also identify those babies who were not screened and the reason, in addition to those babies who passed the screening. The system that is designed must address the need to track those infants who failed or were not screened.

According to the model, infants who failed the screen should be re-screened before referral for diagnostic evaluation by an audiologist. There needs to be a mechanism at the outpatient facility to report the findings. This information is critical to identify the group of infants needing follow-up either because they were missed or because they failed the re-screen.

Audiologists need to report their findings including for those children with late onset and progressive hearing loss. The referral process will be automated and the Confirmed Hearing Loss Report form will be integrated into the WE-TRAC system. The form also serves as a referral to the Birth to 3 Program. Timely communication is needed from the Birth to 3 Program back to the tracking system to confirm the referral occurred and services are being provided.

The other components integral to WE-TRAC are the ability to aggregate data at each level of the EHDI process and to establish a communication back to reporting sources. The aggregate data will include the EHDI national database elements: the number of infants screened before and after discharge; number of infants referred for audiologic evaluation; number of infants receiving audiologic evaluation by 3 months of age; number of infants identified with permanent congenital hearing loss by type and age; number of children with late onset or progressive hearing loss; and number of children receiving Birth to 3 services. Communication back to the reporting sources will enhance individual patient care and provide information for program quality improvement such as hospital referral rate or number of missed infants.

While at the local level some hospitals may have mechanisms in place to assure that infants are screened, diagnosed and enrolled in Birth to 3, however, over half of hospitals report they do not have this assurance in place. In addition, there is not a centralized EHDI tracking and surveillance system in place.

Objective 1: Establish and implement an electronic EHDI tracking and surveillance system. A majority of grant resources will be used to purchase the services of an Information Technology- Project Manager, a Business Process Analyst, and a Programmer Analyst to accomplish this objective. Activities for the objective will progress in five phases: (1) Planning and Requirements Analysis Phase/ Year 1, (2) Design and Development Phase/ Year 2, (3) Integration and Test Phase/ Year 2, (4) Implementation Phase/ Years 3-4, and (5) Operations and Maintenance Phase/ Years 3-4.

Input from parents, reporting sources and the UNHS Implementation Work Group will be an integral component throughout the process.

During the Planning and Requirements Analysis Phase, information will be gathered from the UNHS Implementation Work Group-Data Subcommittee and focus groups to determine user's needs and requirements. A functional requirements document will be created that defines inputs, processes, and outputs. This document will address: integration of data sources such as the birth record and newborn metabolic blood screening program and definition of data elements including those necessary to link the birth record to the newborn blood screening. The document will address system needs from a NEDSS perspective. That is, it will describe an Internet-based infrastructure for data, built on industry standards, policy-level agreements on data access, burden reduction, protection of confidentiality, and security. It will describe a standards-based approach and a modular architectural framework. This ensures that surveillance data may be shared as appropriate through secure systems; that consistent, high quality data can be accumulated; that users familiar with one system can easily use another; and that software and expertise can be easily shared across programs.

Issues related to sharing birth record data will be identified along with system requirements related to security and privacy. Each year a Memorandum of Understanding (MOU) is established between DPH and DHCF that defines the data and technical assistance that BHI will provide to DPH to support Wisconsin's public health programming and data needs. The agreement has two sections: (1) data set construction, standard reports, and vital records access and (2) assistance in meeting DPH-specific information needs. Needs related to EHDI tracking and surveillance will be included in the MOU.

During the Design and Development Phase (Year 2), existing information systems and components will be analyzed to determine their use for WE-TRAC. It is expected that components of HAN (secure web site and alert messaging system) along with NEDSS (Wisconsin's implementation of CDC's national surveillance standards- secure, web-based method for integrating public surveillance and information systems) will provide the infrastructure needed. The EHDI system will be designed and developed to link the birth record to the newborn blood screening to populate the WE-TRAC database. With the Birth Defect Prevention and Surveillance Program in the planning phase, an opportunity exists in the future to populate the WE-TRAC database with birth defect reported information. Subsequent reporting by outpatient facilities, audiologists, and Birth to 3 programs will provide additional data. In addition, the security infrastructure will be defined and addressed. The developed EHDI system will establish mechanisms to collect standard data from multiple sources. Several programs in the BFCH (WIC, MCH and Family Planning/Reproductive Health) have standardized data elements, codes and definitions and include a function to create a shared database at the local level. A similar process would be used to create standardized data elements for WE-TRAC that meet the DHFS and NEDSS identified standards. NEDSS architectural surveillance system standards include: (1) conduct and support web browser-based data entry and data management, (2) accept, route and process electronic XML/HL7 messages containing laboratory and clinical content, (3) participate in an integrated data repository, (4) provide active data translation and exchange (integration broker) functionality, (5) have a transportable business logic capability, (6) provide a data reporting and visualization capability, (7) implement a shareable directory of public health personnel, and (8) implement a security system and appropriate security policies.

Prototype messaging systems and end user interfaces (browser configurations, screens, etc.) will be created and necessary hardware and software (including middleware) purchased for prototyping and beta testing.

The Integration and Test Phase (Year 2) will demonstrate that the developed system meets the requirements specified in the functional requirements document. Data systems reports will be analyzed to demonstrate the ability to track infants and to monitor established WSB benchmarks such as percent screened and hospital referral rates. Selected sites will be provided with a "beta version" of the system. Feedback from the beta testers will be used to standardize the final version.

During the Implementation Phase (Year 3 and 4), there will be a phased rollout of the system. Necessary hardware and software (including middleware) will be purchased. One likely platform configuration for the finished system includes an Oracle DBMS, Java II Enterprise Edition with enterprise Java Beans, an IBM WebSphere web server, and clients using browsers with strong (128 bit) encryption (Netscape or Internet Explorer version 5 or greater). However, the technology planning efforts are not vendor specific. System selection, acquisition, and development will proceed in accordance with State of Wisconsin, DHFS, and CDC NEDSS architectural standards. During this phase maintenance and user manuals, training, and implementation materials will be created including online training using WebCT, a tool for the development of online courseware, on the HAN. Factors affecting the timing of deployment include: DPH region, urban/rural mix, and end user interest. Crucial to implementation is the provision of a Help Desk. End users will have a central point of contact for problem resolution and system support. Systems management reports cataloging bugs, requests for enhancements, and training issues will be reviewed.

The Operations and Maintenance Phase (Year 3 and following) will identify programmatic concerns in areas such as hospital follow-up automation, improved turn-around times for reports, improved submission of input from diagnostic services will also be addressed. A post implementation follow-up review with focus groups and other stakeholders is planned as part of the initial deployment. Sixty to 90 days after system availability, detailed assessments of functionality and utility will be performed to determine areas for improvement during the roll out.

Objective 2: By Year 3, integrate the EHDI data tracking and surveillance system with other newborn data systems. The DHFS data planning efforts described earlier provides a strong foundation to support data integration. The creation and implementation of WE-TRAC will serve as a model for future data integration efforts and is consistent with the mission of WPHDSC "to build and sustain a strong data and information infrastructure, which supports the collection, analysis, and dissemination of information through the activities, performance and outcomes of public health programs and services at the state and local levels". The principle investigators and project staff will inform these efforts of progress throughout the project. Information provided by the Genetics Planning Grant-Child Health Profile feasibility study will assist in planning the EHDI system and support future public health data integration. The architecture envisioned in the Child Health Profile draft addresses the messaging and information exchange requirements of the same public health and private provider system requiring integration for EHDI tracking. These systems can be linked using XML to isolate business logic from presentation and to offer interfaces to public and private provider services.

Objective 3: By Year 3, establish reporting and tracking mechanisms to assure minimal loss to follow-up. The establishment and implementation of the integrated electronic EHDI tracking and surveillance system will support the ability to accomplish this objective. The WSB Program will work closely with its collaborative partners to maintain their support for the EHDI tracking and surveillance system and to promote the importance of the "medical home" and to explore mechanisms for reporting by local Birth to 3 programs. The CSHCN Program and its Regional CSHCN Centers, Birth to 3, and the Bureau for Deaf and Hard of Hearing (BDHH) and its regional offices will play an important role in assuring that families are connected to the services they need. As part of the WSB activities and with input from the UNHS Implementation Work Group, a "best practice" protocol will be established to promote these linkages.

Objective 4: By Year 3, collect, analyze, and report critical outcome data. WE-TRAC will provide a mechanism to collect the necessary information to evaluate the effectiveness of Wisconsin's efforts to assure that all infants with hearing loss are diagnosed by three months of age and are receiving intervention services by six months of age. The CSHCN Medical Director, CSHCN Epidemiologist, and WSB-Program Coordinator will review aggregate data. Beginning in 2003, hearing screening information will be reported on the birth record. The percent of infants screened during birth admission, percent of families who refuse hearing screening during birth admission and percent of infants who refer (fail screen) will be determined. Reports will go back to hospitals regarding the program quality indicators: Percent of infants screened >95% of births and Referral rate <4%. In addition, a report will be provided to the legislature.

In Year 3, analysis will include: percent of infants screened before one month of age, percent of infants who refer on outpatient screen, percent of infants diagnosed by three months of age, percent of infants referred to Birth to 3, and percent of infants receiving Birth to 3 services by six months of age. The CSHCN epidemiologist will perform trend and geographic analysis. Documents will be created to report results.

The success of the WSB Program to date has been in large part due to the collaborative effort of many agencies and persons in both the private and public sector. The UNHS Implementation Work Group and its subcommittees provide representation from a broad array of stakeholders - parents, healthcare providers (audiology, ENT, genetics, pediatrics, speech/language) and payers, early intervention (state and local level), public health (state and local level), public education, and training institutions (MCW and Waisman Center- UAP) (Attachment C). Members of the Work Group disseminate information to their respective profession organizations. With funding provided by the Title V CSHCN Program, WAPC develops and distributes a UNHS newsletter three times a year to over 3,000 persons and agencies. WAPC also maintains a website where the newsletter is posted along with minutes of the Implementation Work Group (Attachment I).

Some key public agencies involved in the WSB Program include the CSHCN and MCH Programs in the DPH, Birth to 3 and BDHH and its regional offices in the DSL, DHCF (Title XIX, Title XXI and BHI-Vital Records), SLH, and Department of Public Instruction.

Some key private partners include WAPC as lead agency in the UNHS initiative and planning; WPDP- as lead agency for training of Birth to 3 providers; WHA- support to the UNHS Implementation Work Group and an integral partner in maintaining hospital support; WSHA- members of UNHS Implementation Work Group, implementation of audiology survey, development of draft Confirmed Hearing Loss Report form, participation in regional forums; and Wisconsin Chapter-American Academy of Pediatrics- support to Work Group and subcommittees, promotion of medical home, and legislative support.

New partnerships have been developed as part of the work of the UNHS data and tracking subcommittee and will play a critical role in the establishment of WE-TRAC.

State Lab of Hygiene (SLH): the manager of the Newborn Blood Screening Program has consulted with the UNHS data and tracking subcommittee. He has helped promote the linking of the birth record to the newborn blood screening via the blood spot identification number.

Bureau of Health Information (BHI): has been involved in the initial planning stages for the EHDI data tracking and surveillance system. The BHI has agreed to include hearing screening data on the birth record, along with a unique identifier that will connect the birth record to the newborn blood screening. They have also identified many of the confidentiality issues that must be considered when developing WE-TRAC.

Bureau of Information Systems (BIS): is involved with many of the public health data initiatives, which are likely interfaces to WE-TRAC. They are knowledgeable about systems and technology planning, network design, and integrated systems implementation, and have extensive knowledge of public health data systems.

UW-DoIT: has been identified as a potential provider of Business/Process Analyst staff for the UNHS project. DoIT has provided analytical and technical implementation support for the Wisconsin HAN and is also collaborating with DPH on the WI NEDSS initiative.

Letters of support from statewide agencies representing hospitals, providers, audiologists, Birth to 3, BHI-Vital Records, BIS, SLH, BDHH, Council of the Deaf and Hard of Hearing, and UW-DoIT are included in Appendix 2. If funded the WE-TRAC Project will work collaboratively with other funded states' surveillance projects.

Specific evaluation criteria have been appropriated for each objective of the grant. This will allow the Principal Investigators, WSB Program Coordinator, and the IT Project Manager checkpoints to assure efficiency, effectiveness, timeliness and quality of work. The specific evaluation criteria are outlined in the Project Activities Time Allocation Table (Appendix 1). This table also serves as an action plan for program and system development and implementation.

Regular meetings will be established with the Principle Investigators, WSB Program Coordinator and IT - Project Manager to closely monitor progress. The IT - Project Manager will become a member of the established WSB Program management team and regularly attend meetings to assure coordination with other WSB Program activities. Semi-annual progress reports will be made to the CDC.

Reports provided by the WE-TRAC system will be analyzed to monitor Wisconsin's progress toward meeting established JCIH performance benchmarks.

VI. Staffing and Management System

Biographical sketches for key personnel are in Appendix 3, organizational charts are in Appendix 4, and position descriptions are in Attachment J.

A) Skills and experience to develop and implement an EHDI tracking and surveillance system.

Sharon Fleischfresser, MD, MPH, Co-Principal Investigator, MCH Medical Director: Dr. Fleischfresser, Medical Director of the Program for Children with Special Health Care Needs (CSHCN) will serve as co-principal investigator for this program. Dr. Fleischfresser has been instrumental in setting up the Regional CSHCN Centers. She serves as co-principal investigator to MCHB Genetics planning grant and CDC Birth Defects Surveillance cooperative agreement. She has also been central to the initiation and development of the WBS program and serves as principal investigator to that MCHB grant (Appendix 3).

Elizabeth Wussow, MA, CCC-A, Audiologist, Wisconsin Sound Beginnings Program Coordinator: Ms. Wussow, the WSB Program Coordinator, is primarily responsible for overseeing the coordination efforts of the UNHS initiative in Wisconsin. She will undertake overall coordination of the program's various components, in conjunction with Dr. Fleischfresser, the co-principal investigator. She will undertake primary responsibilities for implementing and overseeing the programmatic pieces of the WE-TRAC Project (Appendix 3).

Ann Conway, RN, MSN, MPA, Program Director for the Wisconsin Association for Perinatal Care (WAPC): Ms. Conway has been instrumental in organizing the statewide UNHS regional forums conducted in 1999 and 2000. She is the facilitator of the UNHS Implementation Work Group and UNHS Data and Tracking subcommittee. She will act as the WAPC lead in integrating the EHDI data tracking and surveillance system with the perinatal database (Appendix 3).

Gary Hoffman: Mr. Hoffman is the Newborn Blood Screening Program manager at the SLH and supportive of the link between WE-TRAC birth record and the newborn blood screening. He has participated in the UNHS Data and Tracking subcommittee and has provided technical assistance to the WSB program related to tracking and follow-up (Appendix 3).

B) Managerial ability to coordinate the tracking, surveillance, research and integration components of the project.

Frank Paynter, MBA, IT Project Manager: Mr. Paynter is an employee of the Bureau of Information Systems and has been involved in the planning phase of the UNHS data tracking and surveillance system. He specializes in complex systems design, development and project management with an emphasis on the Internet and emerging languages and protocols. Mr. Paynter is currently serving as a consultant for the State Genetics Planning Grant to develop a feasibility report on the creation of a Child Health Profile system for children with special health care needs. He is a member of the WPHDSC and serves as the BIS liaison to the DPH (Appendix 3).

Peggy Helm-Quest MSEd, MHA: Ms. Helm-Quest in the supervisor of the CSHCN Unit and responsible for the day to day operations of that unit including WSB and the proposed EHDI tracking and surveillance project. She has experience in the management of multiple grants including the Genetics Planning Grant, WSB, and the Birth Defects Prevention and Surveillance Grant (Appendix 3).

C) Expertise in abstracting screening, identification and intervention records.

Kristina Stuart, MA: Ms Stuart is the Health Policy Coordinator in the Birth to 3 Program, DSL. She will facilitate the development of a mechanism to report early intervention services as a component of WE-TRAC. She has expertise in local Birth to 3 monitoring and record abstraction.

Sally Meyer, MPH: Ms. Meyer is the Director of the Wisconsin Birth Defects Prevention and Surveillance Program. She will assist in the integration of birth defects surveillance data in the WE-TRAC system.

D) Expertise in epidemiological methods, public health surveillance data, management and computer programming.

Lawrence P. Hanrahan, PhD MS, Co-Principal Investigator: Dr. Hanrahan is the senior epidemiologist in the Section of Environmental Health, Division of Public Health and Chief of the Epidemiology and Toxicology Section. Dr. Hanrahan joined the Division of Health in 1979. He holds both a masters of science and doctorate degree in epidemiology, and is an adjunct professor in Preventive Medicine at the University of Wisconsin, Madison. As principal investigator of Wisconsin's implementation of the National Electronic Disease Surveillance System (NEDSS), he is responsible for overseeing the e-commerce development, implementation and management of Wisconsin's statewide disease surveillance programs. He also serves as the principal investigator for the Wisconsin Health Alert Network program, the occupational Fatality Assessment Control Evaluation (FACE) surveillance program, and the Hazardous Substances and Emergency Event Surveillance (HSEES) system (Appendix 3).

Brian Busby MS, IT-Business Process Analyst: Mr. Busby is the Project Manager at the UW-DoIT in Madison (Appendix 3). He specializes in the design and development of e-Business (web) applications for the UW-Madison campus as well as other State of Wisconsin agencies. Experience includes assessment of customer requirements, knowledge of relational database, security and workflow systems, and various scripting languages used in the construction of web applications. Mr. Busby provides technical assistance in the construction of the Wisconsin Health Alert Network (HAN) web site and is also involved in the technical implementation of Wisconsin's National Electronic Disease Surveillance System (NEDSS) initiative.

Sandi Park, Vital Records Analyst: Ms. Park represents BHI on the UNHS Data and Tracking subcommittee. She will help in the planning and development of WE-TRAC and in the design of output reports. Ms. Park has over 25 years experience in research and statistics projects for Wisconsin state government. Relevant projects include surveillance coordinator and data manager for the state CDC grant for the National Breast and Cervical Cancer Early Detection Program, lead analyst for the Birth and Developmental Outcome Monitoring Program, and Vital Records lead analyst in providing guidance on data requests and research projects. She is experienced in managing major databases, statistical reporting systems, and special studies; in developing data collection and management programs; and in insuring compliance with state and federal regulations. She will work closely with WE-TRAC staff to help insure that state confidentiality requirements are met.

CSHCN Epidemiologist: The CSHCN Program is in the process of recruiting for a 1.0 FTE CSHCN Program epidemiologist whose duties will include assisting in the development and implementation of the WE-TRAC Project.

VII. Organizational Structure

Adequacy of the organization - structure, facilities/space/equipment to carry out the activities of the project: The organization charts (Appendix 4) demonstrate the organizational structure of the DHFS, DPH, BFCH, and the WE-TRAC Project. The WE-TRAC organizational chart reflects the relationship between the three Divisions and Bureaus in DHFS collaborating on this project along with its potential vendor, UW-DoIT. Like the WSB Program, the WE-TRAC project will be administered in the CSHCN Program in the BFCH. BFCH consists of three sections: the Family Health Section that contains the MCH Unit and CSHCN Unit; Nutrition Section that administers the State's WIC (Women, Infants and Children) Nutrition Program and WIC Vendor Section. BFCH is responsible for the Title V MCH Program.

The CSHCN Medical Director (Sharon Fleischfresser) is located in the Family Health Section. The CSHCN Unit Supervisor and the MCH Unit Supervisor report directly to the Family Health Section Chief who serves as the Title V MCH and CSHCN Director. The Section Chief reports directly to the Bureau Director. The CSHCN program staff includes: 1.0 FTE Unit Supervisor (Peggy Helm-Quest) assigned to this project; 1.0 FTE audiologist, WSB Program Coordinator (Elizabeth Wussow); two 1.0 FTE Public Health Nurses, one assigned to the WSB Program; 1.0 FTE Parent Consultant (Loraine Lucinski) assigned to this project; 3.0 FTE health educators (Sally Meyer), one assigned to this project; .5 FTE Genetics Planning Grant Coordinator, one 1.0 FTE program assistant; and 1.0 FTE CSHCN nutrition specialist located in the Nutrition Section. The CSHCN is currently hiring a 1.0 FTE CSHCN epidemiologist who will be assigned to this project. In addition, a Newborn Screening Consultant and a Genetics Consultant are also available for consultation.

The CSHCN Program administers five Regional CSHCN Centers and the WBDPSP. Included is a map of Wisconsin and Regional CSHCN Centers (Appendix 4).

Human Subjects Review

Wisconsin's application is exempt from the Human Subject requirements at this time, as this is a Level 1 grant application regarding surveillance not involving research on human subjects. Wisconsin is in compliance with this requirement. See Assurances - Non-construction Programs form SF-424B (Rev.7-97) #14.