Centers for Disease Control & Prevention EHDI Grants (2000):
Florida

GRANT ABSTRACT
• Grant Narrative

GRANT NARRATIVE

A. Understanding the Problem and Current Status

Florida is interested in addressing the Healthy People 2010 national activity to reduce morbidity and mortality and to improve quality of life, specifically in the area of hearing.

The purpose of the cooperative agreement between the Centers for Disease Control and Prevention and awarded states is to promote the implementation and integration of State-based surveillance and tracking systems for Early Hearing Detection and Intervention (EHDI) and other disorders detected by newborn screening. The purpose of the EHDI program includes screening newborns for hearing loss, audiologic evaluation to identify infants with hearing loss, and early intervention for children identified. Florida is interested in establishing and implementing a State surveillance and data tracking system to assure minimal loss to follow-up by monitoring the status and progress of infants throughout the screening, identification and intervention components of the EHDI program.

In general, Florida remains a state that continues to focus on risk factors as a means of identifying infants who receive hearing screening procedures. Although individual locations within Florida exist where universal newborn hearing screening (UNHS) programs are implemented, there has not been a coordinated statewide effort to initiate UNHS. Based on current estimates, only 18.4% of children born in Florida, including those with risk factors, receive hearing screenings. Given the average age of detection for hearing impaired children not screened at birth remains between 18 and 30 months, and given that Florida has an annual birth rate between 190,000 and 200,000 children, it is unacceptable that only 18.4% of newborns undergo hearing screenings.

The state of Florida has had a risk-based hearing screening program in conjunction with the Early Intervention Programs for many years and is coordinated with the Florida Birth Defects Registry. This service has been extremely valuable but covers only approximately 7-8 percent of the children born in Florida. Universal newborn hearing screening has been a focus of interest at various levels in Florida for the past four years. Discussions to this effect have taken place at both the agency and legislative levels. A legislative initiative to require hearing screening of all newborns made its way through the Florida House and Senate and is waiting the signature of Governor Bush. This bill mandates universal newborn hearing screening services and requires reimbursement on the part of Medicaid, HMOs, and other forms of insurance so that the NIHS programs can be self-sustaining and self-supporting into the future. A funding package for Medicaid accompanied this bill to provide the extra funding required to support UNHS of babies from low-income families.

In FY1998-1999, the Florida legislature funded a pilot project at the University of Florida and the University of Miami to answer specific questions regarding UNHS in Florida. Four major conclusions were derived from the specific design of the study. First, as much as possible needs to be accomplished while the child is still in the hospital. Many factors influenced the return rate of children discharged without test including parents’ perceptions, transportation, economic needs, and managed health care organization policies. Secondly, the disparity in hospital nursery logistics combined with different nursery procedural policies dictated different program designs in implementing screening programs at the respective locations. These two concerns have been addressed in a set of Procedural Guidelines for NIHS screening sites that was developed by a Task Force of audiologists involved with NIHS efforts (Appendix A).

A third concern revealed by the pilot study emphasized the need for systematic tracking and follow-up of children who did not pass the initial screenings. Coordination with the respective Early Intervention Programs for timely intervention services, sharing of information with families regarding intervention options, parent education regarding hearing loss, and timely fitting of hearing aids were all key factors for success in following these children. This area of concern has not been effectively addressed within the State, and underlies the need to apply for this grant funding through the CDC. Lastly, the pilot study found that programmatic costs were very much in line with what others have reported. In general, the larger programs had a less per-child cost than the relatively smaller programs, attributable to spreading the fixed overhead across a greater number of babies tested.

Florida has an annual birth rate between 190,000 and 200,000 births per year. Approximately 90% of these births occur in a hospital setting with the remaining 10% occurring in birthing facilities or in the home. Approximately 100 hospitals are certified to provide maternity services. Therefore, 54 birthing hospitals remain without any UNHS practices in place. Of note is the absence of uniformity among these hospitals. They range in size from over 7000 births per year to 25 annual births; the physical settings are both urban and isolated rural, university medical school based and small private, for-profit hospitals. As such, the strategies for implementing UNHS programs need to be as varied as the range of facilities.

National incidence figures, affirmed by a recently completed pilot study in Florida, suggest that approximately 2.5 to 3 children per 1000 have significant hearing impairment. Based on these statistics and estimates of incidence, approximately 588 Florida infants annually are expected to be confirmed as hearing impaired (incidence = 3:1000; 1998 birth rate =196,000). In contrast, an average between 80 and 90 are reported each year primarily through the risk-based screening programs. With implementation of UNHS throughout the state, an estimated 85% increase in the number of children diagnosed early and enrolled in intervention programs is anticipated. The number of identified children with hearing loss is Florida is currently reported as 3545, with 196 children ages birth through age two, and 3349 children who are qualified as deaf or hard of hearing in grades prekindergarten through grade twelve. Based on the low numbers of identified young children with hearing impairment, much effort is needed to improve identification of these at risk children.

Florida has significant challenges and barriers to implementing an effective EHDI tracking and surveillance program. There are a small number of well-established UNHS programs in some large population centers in Florida. However, there is a lack of coordination of the type of data collected and the manner in which data is currently collected across these programs, as well the lack of a well-defined method by which this data can be most efficiently shared with the Department of Health Children’s Medical Services. In addition, it is unknown the extent to which referral, follow-up and intervention data is being collected. Hence, the number of infants screened, identified with hearing impairment and referred to intervention is currently unknown. There is a great need for a clear statewide plan of coordination of tracking of UNHS programs and subsequent referral and intervention of identified individuals.

Children’s Medical Service procured and provided seed money to interested hospitals in Florida during FY1998-1999. Start-up costs in the form of seed money greatly facilitated initiation of UNHS efforts in 46 hospitals across the State. These hospitals identified a lead audiologist to act as a coordinator of local screening follow-up and implementation of diagnostics to identified babies. Therefore, each hospital had identified audiology diagnostic facilities prior to implementing UNHS. These hospitals also signed an agreement specifying submission of data to Children’s Medical Services upon request. The agreement also required screening sites to refer all newborns not passing the second screening to a primary care physician and the Children’s Medical Services Infants and Toddlers Program. Following funding, technical assistance to these hospital UNHS programs was minimally provided for training and consultation.

A culmination of effort by a Task Force of identified audiologists with expertise and interest in UNHS has recently produced a protocol for screening and referral practices that will be adopted by the Department of Health and represent working guidelines for all UNHS screening sites in the State (Appendix B). With UNHS now mandated in Florida, it is anticipated that increasing numbers of hospitals will implement screening procedures in the near future. Informed consent practices currently vary among hospitals. Some hospitals have standing orders to screen for hearing impairment and provide an option to parents to opt not to have their infant screened. Other hospitals have consent forms signed by a parent prior to each infant receiving hearing screening.

As part of the granting of seed monies to hospitals for start up of UNHS programs, the 46 screening sites agreed to release data upon request to CMS. In order to effectively track current UNHS and Early Intervention Programs, and those that will be implemented in the future, data collection methods and materials need to be in place at screening sites and coordinated at the State level. Personnel need to be identified that would be responsible for coordination of tracking and surveillance of UNHS, in addition to linkage with other state and community agencies and provision of coordination and technical support to new and existing UNHS programs.

B. Goals and Objectives

Goals

1. The University of Florida Database Management Group will develop and implement a statewide UNHS-based early hearing detection and intervention (EHDI) surveillance system by merging statewide multi-source databases and managing this system.
2. The Department of Health, Children’s Medical Services will develop and implement a statewide EHDI tracking system by monitoring the status of diagnostic and intervention services provided to children with hearing impairment from birth to school entry.

Surveillance Objectives

1. Define data collection requirements and methods to obtain UNHS results from screening sites across Florida.
2. Work collaboratively with the Department of Health (DOH) and the Statewide Advisory Group to track early hearing detection and intervention (EHDI) of infants and toddlers.
3. Be the central repository of statewide population-based data and information on identified hearing loss in children.
4. Collect hearing impairment data from statewide sources and merge to form an EHDI surveillance and tracking system.
5. Manage the EHDI surveillance and tracking databases, which are acquired, from multiple sources statewide.
6. Compile hearing impairment data and provide benchmark statistics in tabular format.
7. Prepare countywide and statewide EHDI Reports that monitor the statewide incidence of hearing loss.
8. Develop, maintain, and implement security system for the EHDI surveillance and tracking system.
9. Develop, maintain, and implement confidential information procedures.
10. Development of mechanisms for implementing and reporting fee schedule for non-DOH data requests.
11. Will submit quarterly to PI at DOH contract-related fiscal and programmatic work products.

Diagnostic and Intervention Tracking Objectives

1. Provide technical support to UNHS programs to optimize the efficient identification and reporting of infants with hearing impairment.
2. Define methods to obtain diagnostic results of infants identified by UNHS and subsequently evaluated at clinical audiology sites across Florida.
3. Define methods to obtain intervention information and progress from early intervention programs (EIP) and SKI-HI home interventionists providing services to infants and toddlers with hearing impairment.
4. Work collaboratively with the Florida State School for the Deaf and Blind and the Statewide Advisory Group to track diagnosis and intervention of infants and toddlers with hearing loss.
5. Be the central repository of statewide information on intervention to infants and toddlers with identified hearing loss.
6. Utilize the EHDI tracking to monitor services to infants and toddlers with hearing impairment and their families.
7. Support effective transition of children with hearing impairment from early intervention services to school-based services at age 3.
8. Compile intervention data and provide benchmark statistics in tabular format.
9. Prepare Intervention Reports that describe the statewide intervention services provided to young children with hearing loss.
10. Develop, maintain, and implement a security system for the EHDI intervention tracking information.
11. Develop, maintain, and implement confidential information procedures.
12. Development of mechanisms for implementing and reporting fee schedule for non-DOH data requests.
13. Will submit quarterly to PI at DOH contract-related fiscal and programmatic work products.

C. Description of Program and Methodology

Newborn hearing screening is only beneficial if babies who do not pass the screen are provided with timely and appropriate audiological diagnosis. Unfortunately, this has been a serious problem with existing UNHS programs in all parts of the country. This issue will be addressed in the first year of this grant in two ways.

First, because not all audiologists have the interest or the equipment or experience to do diagnostic evaluations for babies from birth to six months, a survey will be conducted of all audiologists in Florida to determine which ones are interested in being part of a statewide Pediatric Audiological Network. The formal and procedures for this survey will be modeled after similar surveys conducted previously in Utah and Hawaii. Based on the results of the survey, a list will be compiled and distributed to all birthing hospitals specifying recommended audiologists to evaluate babies who do not pass the hearing screening.

Second, based on procedures used successfully in statewide systems in Mississippi and Utah, newborn hearing screening staff in UNHS hospitals will be asked to complete a standard form for all babies who do not pass the hearing screen (estimated to be approximately 2% of all births). The form will be web-based and will contain contact information about the baby, the name of the baby’s primary care physician, discharge diagnosis, information about the audiologist the parent has chosen to perform the audiological evaluation, and permission by the parent for the hospital and the audiologist to share information on the results of the diagnostic evaluation with Children’s Medical Services. Florida currently has a web-based Birth Defects Registry in place that is considered a successful model and will be linked to this similar UNHS database.

The web-based form will also act as a referral form and can be printed at the hospital UNHS screening site to provide copies to the parent(s), primary care physician, and audiologist. To be listed as a member of the Pediatric Audiological Network, audiologists will have to agree to submit results of diagnostic evaluations of referred babies, via the website, within ten days of completing an evaluation.

The proposed EHDI surveillance and tracking system will have two major components. First, resources from the University of Florida Database Management Group will be contracted to develop and manage the EHDI database surveillance system. The University of Florida Database Management Group currently manages the Florida Birth Defects Registry. Second, an audiologist with expertise in hearing loss identification and intervention issues will be contracted with the Department of Health Children’s Medical Services to develop and manage the tracking of services provided to individuals identified with hearing loss. This audiologist can obtain information from the EHDI database and will be able to identify babies who have not received a diagnostic evaluation by the time they are two months old. The audiologist with Children’s Medical Services will contact the audiologist to whom the baby was referred and the parents to assist in completing an audiological evaluation for that baby. If a diagnostic report is not submitted within 30 days of the telephone call, a report will be sent to the local health department serving the infant’s place of residence. The local health department then will contact the family and arrange for a diagnostic evaluation.

Referral to the Children’s Medical Services Infants and Toddlers Part C Early Intervention Program is initially made by the physician or the audiologist who performs the diagnostic evaluation. The parents of an infant with hearing loss is contacted by the nearest Early Intervention Program to offer assistance with care coordination and, if financially eligible, ongoing financial assistance from DSCC. Prior authorization from DSCC is required for ongoing audiological services such as hearing instrument evaluations and provision of hearing instruments. DSCC also informs families about the Part C Early Intervention Program and assists the family with a referral if needed. Information about the availability of SKI-HI home intervention services for families with infants who are hearing impaired will also be shared.

Medical eligibility for the CSHCN program for hearing impairment includes a hearing loss of at least 25 decibels +/- 5 decibels or greater based on a pure tone average 500, 1000, 2000, and 3000 Hertz; or a hearing loss in one ear only of 50 decibels +/- 5 decibels at 500, 1000, and 2000 Hertz. If medical eligibility is met and the family needs financial assistance to obtain appropriate specialty care for the child's condition, financial eligibility criteria must be met. The financial guidelines were recently changed to allow eligibility for families with total income up to 285% of the federal poverty level. Since many insurance companies do not cover hearing instruments and related supplies or cochlear implants, DSCC is often the only resource for families needing these services. Additionally, DSCC covers otologic and audiologic care for financially eligible children.

Infants with a bilateral hearing loss of 40 dB or more are eligible for Part C EI services. Families pay a maximum of $100 annually for services, along with a proportion of the cost of hearing instruments.

Early Intervention Programs are required to provide data to Children’s Medical Services. It is imperative that developmental language data be compiled for infants with hearing loss. In a process modeled after early intervention programs in Colorado, parents will be asked by Early Intervention Programs to complete the MacArthur Scales of Language Development within 30 days of entry into the early intervention program, and at 6 month intervals as appropriate until school entry at age three. Yoshinaga-Itano (1999) found that parents of children who are deaf or hard of hearing are accurate reporters of their children’s level of receptive language development. In addition, SKI-HI Communication Scales information will be requested from interventionists providing SKI-HI services to families of identified children with hearing impairment.?

The Florida EHDI Project will be administered through the Children’s Medical Services’ Bureau of Prevention and Early Intervention. The project will be integrated into the Infants and Toddlers Early Intervention (EI) Program. Currently one staff person has responsibility for the risk-based hearing screening program, this individual will work on this project and provide initial project coordination. CMS will hire a 60%-time statewide Audiology Consultant who will have certification as an audiologist. This Consultant will be the ongoing director of the diagnosis and intervention tracking portion of the project. The University of Florida Database Management Group will be contracted for all management of data collection, surveillance and reporting systems.

The focus of project activities during first year will be establishment of, the Advisory Council, development of the database management system, hiring of the Audiology Consultant, development of screening, tracking and report protocols, and technical support to new or existing UNHS screening programs as required.

CMS will establish a EHDI Advisory Council. The Council will include representatives from the following constituencies and groups: Targeted members of an EHDI Advisory Council include representatives from the Department of Education, Florida School for the Deaf and Blind, Audiology UNHS Task Force, Medical Association, families, Early Intervention Programs, Florida Speech and Hearing Specialists Association (FLASHA), Florida Pediatric Society, hospitals, CMS, Agency for Health Care Administration (Florida Medicaid agency),, service providers, and others. The council will not exceed 15 members and will meet at least quarterly. Responsibilities of the Council will be to provide advice and input for the project regarding strategies for improving effective screening, diagnosis, and intervention for babies in Florida.

EHDI Database Surveillance System

1. Create database files in the Microsoft SQL Server environment.
2. Design all data tables, data views and reports.
3. Develop and maintain a comprehensive data directory.
4. Design and maintain accurate meta data.
5. Define any additional data sources.
6. Develop public access version of BDR summary data to be distributed on DOH Website.
7. Maintain security and confidentiality of Information System.

Activities

The contracted University of Florida Database Management Group will:

1. Develop appropriate data collection and referral forms in conjunction with the Children’s Medical Services audiologist to be used to collect data via the website.
2. Develop EHDI tables which will describe statewide and by county:
   1. The occurrence of hearing impairment by type.
   2. Hearing impairment rates.
   3. Hearing impairment trends.
3. Develop methodology for acquisition, merging, management, analysis and reporting of data from UNHS sites, in conjunction with the hospital contact personnel coordinating UNHS and early intervention programs (EIP) providing services to young children with hearing impairment.
4. Develop methodology for acquisition, merging, management, analysis and reporting of data for DOH review, in conjunction with Children’s Medical Services staff.
5. Develop an evaluation plan in conjunction with the Department of Health, Children’s Medical Services.
6. Develop capacity to produce standard tables of hearing impairment rates, counts, and annual reports, in conjunction with the Department of Health, Children’s Medical Services.
7. Develop database management capacity for multiple disabilities, in conjunction with the Clinical Genetics and Epidemiology groups.
8. Develop annual progress reports and submit to CMS in a timely manner so reports can be provided to CDC no more than 30 days past the end of the grant period.
9. Develop and document mechanisms to ensure confidentiality of patient records, in conjunction with the Department of Health, Children’s Medical Services and Clinical Genetics and Epidemiology groups.
10. Provide technical training in data linking methodologies.
11. Maintain information security policies, protocols, and procedures for Florida’s EHDI surveillance system.
12. Maintain confidentiality security policies, protocols and procedures for Florida’s EHDI surveillance system.
13. Have a designated security coordinator who will monitor and maintain security policies.
14. Have a designated information coordinator who will monitor and maintain confidentiality policies.
15. Develop and maintain retention and archiving records policy.
16. Maintain secured areas of information storage and backup.
17. Maintain confidentiality of HIV/AIDS, STD, and TB case reports.
18. Maintain release of data protocols and policies.
19. Maintain information resource management security policy.

Construction of the EHDI surveillance and tracking system will be accomplished by acquisition of the following databases (See attached table 1 and associated variables). In addition, the Department of Education Special Education Database Birth-to-One Year following will also be utilized:

Each database will be abstracted and analyzed to identify each individual child with hearing impairment using ICD-9 classifications 740.0 – 759.9, and possibly other ICD-9s (see attached table 2). Each of these separate databases will then be merged to provide unduplicated records which will be the EHDI surveillance records for that time period.

From these database files, production of descriptive statistics and tabular reports will be developed. A final product will consist of statewide and county-level reports of childhood hearing impairment by type, incidence and trends.

EHDI Diagnosis and Intervention Tracking System

1. Work with University of Florida Database Management Group to develop appropriate data collection and referral forms to be available on the web-based data system.
2. Conduct a survey of all audiologists in Florida to determine practitioners interested in being identified as a member of the Pediatric Audiology Network.
3. Obtain database information from the University of Florida Database Management Group specifying individuals that did not pass second UNHS screening and the intervention information provided by early intervention programs.
4. Maintain contact with UNHS screening sites and clinical audiology centers to track the performance of diagnostic hearing evaluations for all identified infants.
5. Develop and maintain a comprehensive tracking directory.
6. Facilitate a working relationship between interventionists within Florida resulting in a position paper guiding the provision of appropriate early intervention services to infants and toddlers who are deaf or hard of hearing.
7. Maintain contact with early intervention programs (EIP) and SKI-HI to track the initiation and progress of early intervention to families of infants with identified hearing loss
8. Review baseline language development data obtained by early interventionists upon entry into intervention program that is reported to the surveillance database.
9. Review language development data at 6-month intervals from early interventionists that are reported to the surveillance database.
10. Develop public access version of intervention summary data to be distributed on DOH Website.
11. Maintain security and confidentiality of Information System.

Activities

The Department of Health Children’s Medical Services contracted audiologist will

1. Develop methodology for acquiring, managing, and compiling data from University of Florida Database Management Group
2. Develop methodology for contacting, monitoring, and providing technical support to UNHS screening sites to improve screening efficiency.
3. Develop methodology for contacting and monitoring the provision of diagnostic audiology evaluations to infants identified by UNHS.
4. Develop methodology for contacting, monitoring and providing technical support to early intervention program providers to initiate intervention programs and regular evaluation of language development of identified young children with hearing impairment.
5. Prepare and publish manuscripts which describe the tracking system, methodology, relationships, etcetera in collaboration with UNHS or intervention sites as appropriate.
6. Develop an evaluation plan of tracking objectives in conjunction with the Department of Health, Children’s Medical Services.
7. Develop management guidelines for children with identified multiple disabilities, in conjunction with the Florida School for the Deaf.
8. Develop and document mechanisms to ensure confidentiality of patient.
9. Provide technical support in UNHS, audiological diagnostic and intervention methodologies.
10. Maintain information security policies, protocols, and procedures for Florida’s EHDI intervention tracking system.
11. Maintain confidentiality security policies, protocols and procedures for Florida’s EHDI intervention tracking system.
12. Develop and maintain retention and archiving records policy.
13. Maintain secured areas of information storage and backup.
14. Maintain confidentiality of HIV/AIDS, STD, and TB case reports.
15. Maintain release of data protocols and policies.

Maintain information resource management security

D. Evaluation Plan

Determination of the impact of UNHS on the health/medical, developmental, and educational outcomes for Florida’s children is critical to assessment and evaluation of the effectiveness of the EHDI surveillance and tracking system. The assessment and evaluation protocols for the project, quality assurance procedures, and appropriate data for analysis will be identified at the end of the first year of the project. The project will look at both program standards and program outcomes. Program standards will focus on program compliance rates, provider participation, and screening results. Program outcomes will investigate child status related to enrollment and participation in the Infants and Toddlers Early Intervention Program, functional status in the areas of communication and language development at key developmental points, access to health/medical care and early intervention services, and program placement at age three (either in a school district prekindergarten disability program or other program). Analysis of program outcomes will be facilitated by coordination with the Florida Department of Education (DOE) and by the fact that the EI Program is a component of CMS. The EI Program data system has the ability to match and track child specific records from the EI Program database through the DOE student data base. EI Program records can also be matched and tracked to identify children who are being served through the CMS specialty medical clinic programs.

Reporting requirements are an essential component of the development of assessment and evaluation protocols. Each birth provider (hospital, birthing facility, home birth caregiver) will be required to report information as children are screened. Minimum data reporting elements will include: number of births, number of screens, results of screens. Hospitals will be required to provide child specific data for each child that is discharged without an initial screen having been conducted and for each child that is discharged with a failed screen, and those with certain progressive hearing loss indicators. UHNS enrolled hospitals will enter data into the EI Program WEB-based data system. Data for each hospital will be maintained as a unique referral file to facilitate tracking and program standards analysis. Child specific data will minimally include child identification information, result of failed screen, and name of child’s primary care physician, the audiologists selected by the parent to perform the diagnostic hearing evaluation, and parent release of confidentiality to share information from hospital and audiologist with Children’s Medical Services. Audiology providers will be required to submit child specific follow-up diagnostic evaluation data on each child who failed screening for entry into the web based data system. The local EI Program will be responsible for entering data of infants identified with hearing impairments who are referred to their program for early intervention services. Data provided for these children will include results of evaluations, functional status data, service recommendations and interventions provided, and demographic data. The Referral data set will include a tickler/reminder system to identify on a monthly basis infants with outstanding screening information to facilitate follow-up by the responsible EI Program.

The EHDI quality assurance procedures will be a adjunct to the EI Program quality assurance program. The Children’s Medical Services audiology consultant will have primary responsibility for conducting period quality assurance reviews of UNHS. Reports will be generated based on quality assurance reviews and correct actions required when appropriate. In addition, quality assurance results derived from the EI Program activities will also be used to assess the effectiveness of the EHDI program.

Data reports and analyses will be generated and reviewed on a quarterly based. It is anticipated that standard reports related to assessment of program standards will minimally address: screening/referral profiles by hospital and other facilities; profiles by county and by EI Program service area; profiles based on SES data (e.g., Medicaid, insurance, HMO, no insurance); and by diagnostic information. From these data profiles, statistics can be derived that reflect "averages" for program standards such as initial screen compliance, screen failure rates, false positive rates, and referrals. These data can be used by the Advisory Council and consultants to review UNHS best practice standards and to target areas in need of training or technical assistance. This data can also be used to determine FTE requirements for effective screening programs, numbers of community providers needed, etc. Data will also be generated and reviewed on a quarterly basis related to program outcomes will minimally address: percentage of UNHS identified infants with a primary medical/health care provider identified; number of UNHS identified infants enrolled in local school district hearing impairment programs; age of referral of UNHS identified infants to the EI Program, number of UNHS identified infants being served by SKI-HI home intervention programs, discharge status of UNHS identified infants. These data can be used by the Advisory Council and consultants to identify UNHS best practice standards and to target areas in need of training or technical assistance. Program outcome data that tracks child placement in local school district program will be generated on an annual basis, since this information is provided by DOE on an annual basis. Analysis of program outcomes data will provide information on the overall effectiveness of the UNHS program in attaining the stated program goals and improving the health, medical and developmental status of infants.

Specific outcomes of the evaluation plan include:

1. Documentation of the number of babies identified with hearing loss by UNHS
2. Hit rate, loss-to-follow-up rate, referral rate of UNHS screening sites
3. Documentation of the number of babies with hearing loss receiving early intervention services
4. Improvements in collaboration via the EHDI Advisory Council
5. Improvements in accessibility of a network of appropriate early intervention services for children with hearing impairment and their families

E. Collaborative Efforts

Since the UNHS project will be incorporated into the Early Intervention Program, the project will benefit from the local networks which have been established throughout the state as part of the EI Program. Local hospitals are already familiar with referral procedures to local EI programs for infants with special needs, so expanding the networks to include a greater focus on newborn hearing should be simplified. In many areas, efforts to move toward universal screening have resulted in the development of local coalitions focused on this issue. Each of the fifteen EI Programs has an individual designated as the Infant Hearing Impairment Program coordinator. These individuals are usually audiologists with extensive experience in infant hearing screening. These representatives have been meeting for many years to develop infant hearing protocols and provide a basis for identifying regional consultants for the project.

The development of a statewide EHDI Advisory Council is necessary. Currently, early intervention services appropriate to infants and toddlers are not being provided in an equitable or most appropriate manner in all geographic locations in Florida. At present, early intervention services may be provided by EI programs, which may or may not have persons with special training specific to the needs of children with hearing impairment. Likewise, a considerable number of school districts serve birth-to-three children, however, many of these service models do not provide programs with the intensity or specificity to meet the needs of this population. A SKI-HI early intervention program is available in conjunction with the Florida School for the Deaf and Blind. Although there is a network of SKI-HI early interventionists in many parts of Florida who have been specifically trained to work with families of infants with hearing loss, this program is under-funded and accessible to only a minority of families that will be identified. Development of an EHDI Advisory Council can result in the development of a position paper which would guide the provision of services to infants identified by UNHS.

The EHDI Advisory Council will include representatives from the following constituencies and groups: representatives from the Department of Education, Florida School for the Deaf and Blind, Audiology UNHS Task Force, Medical Association, families, Early Intervention Programs, Florida Speech and Hearing Specialists Association (FLASHA), Florida Pediatric Society, hospitals, CMS, Agency for Health Care Administration (Florida Medicaid agency),, service providers, and/or others. These meetings would be facilitated by the Consulting Audiologist at Children’s Medical Services. The council will not exceed 15 members and will meet at least quarterly.

F. Staffing and Management System

This project will be an integral part of the Florida Infants and Toddlers Early Intervention (EI) Program. Existing resources used to support the overall EI Program will also be available to support the UNHS Project. Programmatic management of the project will be handled by staff in the Bureau of Prevention and Early Intervention. Staff currently assigned responsibility for coordinating the risk-based Infant Hearing Impairment Program activities will provide support to the initiation of this project.

The EI Program has established fifteen service areas throughout the state that form the basis for development of service delivery systems. Generally, these service areas encompass the service cachment areas for certain hospitals and this has historically facilitated the development of effective referral and service provision procedures. Data management activities will be contracted with the University of Florida Database Management Group, currently under contract to CMS to operate and maintain the EI Program data management system

This project will be an enhancement to the Florida Infants and Toddlers Early Intervention (EI) Program. While existing resources used to support the overall EI Program will also be available to support the EHDI surveillance and tracking project, additional resources to ensure appropriate infrastructure to support a statewide EHDI program are required.

G. Organizational Structure and Facilities

The Florida Department of Health is directed by the Secretary who is also the State Health Office. The Secretary answers directly to the Governor. The Secretary is assisted by a Deputy Secretary, a Deputy Secretary for CMS, and a Deputy State Health Officer. The Deputy Secretary for CMS is a practicing pediatrician. CMS has two divisions: CMS Network which includes the Clinic and Regional Programs and the Managed Care Bureaus; and Prevention and Interventions which includes the Prevention and Early Intervention and the Child Protection/Special Technologies Bureaus. This project will be organizationally within the Bureau for Prevention and Early Intervention within the Division for Prevention and Interventions. (see Attachment ___, Organizational Chart).

The Department of Health works closely with the Department of Education on many issues related to health services for school-age children. The interagency agreement between the departments is being updated to reflect organizational changes over the past several years. The interagency agreement establishes referral criteria for infants identified with hearing impairments to the local school districts for educational management evaluation and services and the requirement for school districts to refer infants and toddlers identified with significant sensory impairments to the CMS Infants and Toddlers Early Intervention Program for eligibility determination.

The Department of Health also has an interagency agreement with the Agency for Health Care Administration (ACHA), the state Medicaid agency. ACHA and DOH collaborate on many program issues including the implementation of Florida KidCare, targeted case management, and provision of early intervention services for infants and toddlers. Staff from ACHA and CMS have been coordinating a statewide workgroup which has been investigating strategies to move toward implementation of universal newborn hearing screening in all birthing hospitals.

Children’s Medical Services has established a network of fifteen Early Intervention Program core providers that are responsible for local coordination of the Infants and Toddlers Early Intervention Program. CMS contract annually with these providers. The current risk-based infant hearing screening program is coordinated through these community providers. Mechanisms are in place, through the fifteen Infant and Toddler Early Intervention Regional Policy Councils, to coordinate collaborative activities within hospital cachment areas for training and support for implementation of universal newborn screening programs. These activities will support the efforts of the UNHS technical assistance teams developed through this grant.

H. Human Subjects Review

Budget Justification

Personnel are needed to administer a statewide program, resources are required to support a statewide Advisory Council, and a data management and evaluation activities.

Resources to support the activities of a statewide EHDI Advisory Council are needed. These resources will support travel and meeting expenses for Council members, not to exceed a total of fifteen. The Council will meet at least quarterly during the first year in order to assist in timely implementation of the EHDI program. Council members will not be paid for their time working as Council members, however, families members may receive stipends or reimbursement for child care or other approved expenses.

CMS will require additional professional staff for statewide administration of the EHDI program. A 60%-time Statewide Audiology Consultant will be hired as a contract employee (Job description Attachment __). This individual will provide clinical expertise related to implement a tracking system for diagnostic evaluation and intervention of UNHS infants identified with hearing loss. Additional expertise would include technical support to new and existing UNHS programs, and a background in effective diagnostic and intervention practices with young children who are deaf or hard of hearing. The Audiology Consultant will be responsible for the day-to-day operation of the statewide EHDI program, abstraction of screening, identification, and intervention records, and facilitation of the EHDI Advisory Council meetings (Job description Attachment __).

The University of Florida Database Management Group will be contracted to provide all computer programming and related data management, as well as management and coordination of all surveillance, data tracking, and integration components of EHDI project. The University of Florida Database Management Group will be responsible for the timely submission of progress reports to CMS, including annual data reports due to the CDC at the end of the grant period.