Delaware MCHB 2002 Grant Program Narrative

Problem/Current

StatusDelaware does not have mandated universal hearing screening. Until recently, some of the birthing hospitals were only screening babies at higher risk for hearing deficits; however, as of a year ago all birthing hospitals in Delaware have voluntarily committed to provide universal newborn screening. Yet there is a significant deficiency with aggregate data to determine the incidence of hearing deficit in Delaware among newborns.

It is estimated, based on national statistics, that in Delaware there are approximately 900 babies annually who either fail or do not have their hearing screen done by the time of discharge from the hospital or other birthing sites. These babies need repeat testing and tracking to ensure they're having appropriate diagnosis of their hearing status. There are over 140 babies born outside the hospital setting or outside Delaware who will require tracking and appropriate testing, from their initial screening to diagnosis if necessary.

There are approximately 10,500 births annually in Delaware. Currently the six birthing hospitals voluntarily screen 90% of all Delaware born newborns, 81 % are tested before hospital discharge through parental informed consent. There are approximately 100 births annually between an independent Birthing Center and a midwife delivering the Amish and Mennonite communities. Our main difficulty is the lack of a system to track babies who fail their screen. We know some of them are tested and diagnosed but we have no way of determining how many and what type of care they are receiving.

Of the six birthing hospitals, four have purchased the OZ Systems Newborn Hearing Screening and Management Solution (SIMS) system. The other two, due to financial constraints have not, nor in the near future plan to budget for this equipment. The voluntary screening is not part of the delivery package for babies born at the independent birthing center or for the Amish and Mennonite deliveries.

Despite screening occurring at the birthing hospitals, and recording on the OZ system at the four facilities, an existing barrier is expanding the recording system to the two hospitals, as well as providing screening equipment and OZ equipment for the birthing center and facilitating screening and recording for the Amish and Mennonite communities. Even with supporting infrastructure for the birthing sites, the lack of centralization of data with dedicated staff to identify abnormal screens, track and facilitate intervention is a significant deficit.

Any hospital can easily maintain a database of the patients tested before newborn discharge. It becomes more complicated to track outpatient testing as the numbers of providers and agencies involved increase. The component that is lacking is the level of coordination that can only be carried out by dedicated staff and a dedicated data base management system.

Delaware has a successful metabolic newborn screening program (NSP) with a 99.7% compliance rate for first screens and the developing birth defects registry. The intent is to mirror the hearing program after the metabolic program. The newborn screening staff input all demographic data on each newborn and the lab results are merged through the "kit" number. Verification of demographic data and lab is done on a daily basis. Crosscheck occurs with the Birth Certificate information. The Division of Public Health Newborn Screening Program converted the previous paper system in 1994 to a comprehensive computer system, which provides information on all infants tested. This system was updated to incorporate the changes required for the implementation of the NSP regulations. The current NSP system was developed and is maintained by the Rapid Application Development (RAD) team through the State's Information Management System (IMS). The NSP Program is responsible for follow up of all test results. Normal screens are automatically closed by the system. Abnormal newborn screens are reported to the primary care provider and the parents. All abnormal newborn screens are reviewed bi-weekly by the Genetic Team which consists of the Medical Genetics Director (MD Genetics), Director of Women's & Reproductive Health (Nurse Practitioner), Genetic Counselor, and the Newborn Screening/Birth Defects Coordinator. Follow-up is ongoing, unless the case is closed.

Newborns with confirmed abnormal results are referred to Child Development Watch (CDW) for case management. Child Development Watch is a team approach to case management for children at risk. Routine contact is made with the identified case manager (nurse, social worker, or nutritionist) by the Genetics Director to assure continued medical management and offer genetics services including genetic counseling for the families.

Our largest challenge is bridging the gap between the screening facilities and ensuring timely and adequate follow-up of hearing impaired infants. Currently there are differences in the follow-up procedure between up state and downstate Audiologists. With the development of the protocol for Centers of Excellence, Audiologists and the Medical Home will have a clear understanding of where their infants can go for treatment and intervention. There will also be established guidelines for referrals.

We have accomplished several tasks to reduce this problem. These tasks included preparing surveys (APPENDIX A) to send to audiologists to determine the number of audiologists who feel qualified to assess and amplify the infant population. As a result of this survey, a protocol will be established to develop Centers of Excellence. These centers will be used as diagnostic centers where infants and their families can go to receive the most current, accurate diagnostic tests to determined the exact type and degree of hearing loss and provide accurate amplification as rapidly as possible.

The Delaware Infant Hearing Assessment and Intervention Program (DIHAIP) of the Delaware Chapter of the American Academy of Pediatrics, a statewide steering committee to support the establishment of a universal infant hearing assessment and intervention program began May 1999, led by Carlos Duran, MD, Christiana Health Care Systems, Neonatologist. Representation on the committee includes medical professionals with expertise in the area of audiology, consumers, representation from each medical facility, and persons and families with hearing disorders (APPENDIX B). It is through this committee's work that voluntary screening is occurring at the birthing hospitals. The committee offers support for expanding to a centralized dedicated program to provide the detection, intervention, tracking, research, and integration.

Maryland, Pennsylvania and New Jersey border Delaware. Currently, no reciprocity between the states is occurring with respect to Newborn Hearing Screening. We have recently begun to network with these neighboring states to make contact with Directors of their State programs to begin mapping out a path toward shared information.

Evidence is clear that implementation of universal newborn hearing screening substantially lowers the age at which children with congenital permanent hearing loss are identified and that children who are identified early do better on school related measures. This holds true not only for children with severe bilateral hearing deficits but also for children with mild and/or unilateral deficits.

In the United States the mean age at which hearing loss is identified in children is between 20 to 24 months (USDHSS 1990). Mild and moderate hearing losses are identified even later, generally at or after 4 years of age (Coplan, 1987). Severe language delays for the child, as well as emotional distress to both the child and family may result with delay in identification. It is evident that there are high cumulative costs associated with educational, vocational and public assistance programs to assist the hearing disabled. Recent studies indicate that the child's and family's outcome can be significantly altered with early diagnosis and intervention ( Yoshinaga-Itano, Sedey, Culter, Albert, 1998).

The feasibility of universal newborn hearing screening (UNHS) and the benefits of early intervention for infants with hearing loss are supported through considerable data. Specifically, it is noted that infants who are hard of hearing or deaf who receive intervention before 6 months of age maintain language development commensurate with their cognitive abilities through the age of 5 years (Yoshinaga-Itano, 1995; Yoshinaga-Itano, Sedey, Coulter, & Mehl, 1998).

The US Department of Education reported that in 1990 the annual cost to place a child with hearing loss in a regular, mainstream class was $3,383. The cost for a child with hearing deficit in a self-contained class was $9,689 and in a residential programs $35,780 annually. Over 12 years of school the cost in a regular class would be $40,596 versus $429,360 in a residential facility for a possible saving of $425,977 per child! (Johnson, Takekawa, Simon, Sia, Blackwell, 1993).

A life long cost to society may be caused by failure to provide early detection and intervention. A 1984 Bureau of Census survey of income and program participation included figures for non-institutionalized deaf and hard of hearing individuals that indicated that 33% of hard of hearing and 45% of the deaf population were out of the workforce and had no earnings. More than 50% of those employed earned below the poverty level. Deafness and hard of hearing is the sixth most prevalent chronic condition in the US, as noted in CDC reports USDHSS 1990).

Recently, studies have linked some disorders with genetic research. There are many issues, including public health, ethical, and policy implications, that must be addressed with this type of research. It is essential that individuals who are hard of hearing or deaf must play a significant role in developing policies regarding the appropriate use of genetic testing and counseling for families who carry genes associated with hearing (Brick, 1999). Other areas that must be considered are individuals privacy issues, including the potential impact of this knowledge on educational and vocational opportunities, as well as insurability.

As previously stated, there is no state data available to determine the incidence of hearing deficit in DE among newborns. We are fortunate that all of our birthing hospitals have volunteered to provide universal newborn hearing screening. However, there is not a mechanism to centrally track and follow-up the newborns after discharge. Since the implementation of universal newborn hearing screening it has become apparent that not all families are following through with subsequent screens if their insurance does not provide coverage. Also, currently minimal birthing center newborns are not being screened; nor the Amish/Mennonite home births. With implementation of a comprehensive newborn screening case management program a mechanism to track and follow-up identified hearing impaired newborns will be developed and implemented, and programs and progress will be documented. The newborn hearing screening staff can facilitate resources and referrals for appropriate care. It is obvious that a program such as this will provide the needed screening, follow-up and services by early identification and intervention, and also heighten awareness of the necessity of the program development. The Delaware program will mirror the federal government's new goals in Healthy People 2010, which are:

• To increase to 100% the proportion of newborns served by state-sponsored early hearing detection and intervention programs.
• To provide 100% of newborns access to screening
• To increase to 100% the proportion of newborns served by state-sponsored early hearing detection and intervention programs.
• To provide follow-up audiologic and medical evaluations before 3 months for infants requiring care.
• To provide access to intervention before 6 months for infants who are hard of hearing and deaf.

As quoted from the National Newborn Screening & Genetics Resource Center Consultant Report, December 11-13, 2000, "It is strongly recommended that the newborn hearing screening data system and the newborn metabolic screening data system be consolidated into one newborn screening database. Considerations of the need for such a system have already been recognized in DE and steps have already been taken to include minimal hearing data elements on the newborn screening form. This system is exemplary of one way of quickly obtaining hearing information on each and every newborn in the state, and integration into follow-up system can be easily facilitated by this approach. Both newborn screens (hearing and metabolic) contain essentially the same patient demographic information and both have their origin at essentially the same time and place---the newborn nursery.

The newborn hearing screening follow-up module is philosophically similar to the modules that are needed for all areas of newborn metabolic screening. The case management for both can either be part of the DE newborn screening follow-up system that already exists (with additional personnel) or could function as a separate system with access to the data system in which all newborn screening case management data reside. A separate data system is not necessary especially given the sophistication of the current DE newborn screening case management system. An example of how the data flow in such a system might work is illustrated in Appendix B.

In this integrated data/follow-up system, which is similar to the one already proposed I DE, the parent would be given notification of the hearing results at the hospital along with a letter to his/her physician indicating failure to pas the test, if appropriate. The testing results, or lack thereof, would be reported on the metabolic screening form providing the screening laboratory, and thus the state health department, with hearing screening on every infant. The notification of the testing results to the physician would be accompanied by a postage paid envelope containing a follow-up form to be completed at the confirmatory examination and returned to the state health department in order to complete the follow-up record and trigger a response for services, if one were required. While a certain percentage of these forms would not make it back to the health department, a sufficient number should be returned such that the follow-up coordinator for hearing screening would only have to pursue follow-up for a limited and manageable number of presumptive positive newborns. This system takes advantage of the follow-up infrastructure for metabolic screening that has developed over the past 40 years and minimizes duplication of services at the hospital.

A comprehensive computerized follow-up system should be able to track all newborns presumptively positive for any of the newborn screening disorders including hearing loss. It should also be able to track all newborns not receiving laboratory or hearing testing either because of early sample collection, inadequate or unsatisfactory samples, or because of some testing anomaly or failure to test. It should be capable of automatic generation of follow-up letters, automated reminders of requested samples or information not received, and creation of various types of management and summation reports. All babies monitored and tracked through the system should be followed according to established protocols that result in a defined endpoint and the system should have the capability to provide all required legal documentation in this regard. Outcome data should be included as part of the system for all disorders and hearing and various data reports sufficient to evaluate the system and to answer epidemiological questions related to incidence should be included.

Data from all initial screening tests (metabolic and hearing) should be available in electronic format for any physician who might have a need for it. Currently almost all of the Delaware birthing hospitals have obtained the same computer system (OZ Systems) for following hearing results internally. An effort should be made to ensure that these systems do not unnecessarily cause duplication of effort at the hospitals, and any data needed from these systems should be integrated into the newborn screening systems already in place. The biggest problem currently facing hearing screening programs is excessive numbers of newborns that do not receive appropriate follow-up testing. The infrastructure from the DNSP should serve as an example of how to ensure that no newborns are lost to hearing follow-up. Ultimately, a voice response/fax result system for physicians' follow-up use for all of newborn screening would seem a reasonable system goal. Such systems currently exist in a number of state programs (APPENDIX C)."

The Birth Defects Regulations include abnormal hearing screening as a reportable variant. To request results for all newborns, as with the NSP blood screening program, an amendment to the current Regulations, is recommended to create the infant's comprehensive case management file. Clearly, confidentiality issues need to be addressed with the structure of this program. It is essential that family and infant information not be transmitted nor accessible in unsecured data formats.

With funding the Division of Public Health will build the infrastructure to incorporate a centralized comprehensive case management profile for every newborn screened. The current NSP blood specimen has consistently averaged a 99.7% compliance for first time screens. The program also cross references with the Vital Statistics birth certificates as a quality assurance measure to capture missing documentation or screens for each program, respectfully. The program will contract with an Audiologist for up to equivalent .3 to assist with the establishment of protocols and procedures, work with the hospitals, medical providers, and families, and help with the development and implementation of the educational component for the providers and families. The program will increase its IMS support by .5 FTE Application Support Specialist to work with the development of the integrated NSP blood screening, hearing screening and Birth Defect system to develop the infrastructure and provide maintenance. The program will increase its staff by 1 FTE to coordinate the centralized database to track all infants and to assure their newborn screening is complete while working in partnership with the hospitals with program progress. This position will also track all the infants who fail their hearing screen until they reach school age and are transitioned into the school district system. This position will be located within the Newborn Screening (metabolic disorders and hemoglobinopathy disorders)/Birth Defect cluster and all staff will be cross-trained for data entry and coverage.

The metabolic newborn screening program is in the process of expanding with Tandem Mass Spectrometry. With this expansion an increase in charge to the birthing hospitals is in process. It is proposed to include hearing in the comprehensive package during the third year of the grant and research the potential for state funding to defray the cost difference, if necessary to sustain the program. The funds would support the positions in the central office, the consultant and the IMS staff who maintain the equipment and revise the data fields as necessary.

Currently, the Immunization Program obtains the demographic information from the metabolic program and enters it in a separate data system. The program is in the planning stage of revising its current program to be rewritten to 32 bit program. Preliminary discussion is in process as to how we can link this program in future as well.

This grant will help develop an effective EDHI Program for the State of Delaware; and will only be successful if it involves activities that will:

• include 100% of the births in Delaware;
• assure early identification and intervention;
• provide a centralized program to receive the data from all birthing facilities and link with the existing metabolic newborn screening program data base and developing birth defects-to provide a comprehensive newborn screening data field for each newborn; and
• provide for a network of trained and informed providers and the availability of appropriate quality service for children and families;
• provide ongoing program evaluation and quality assurance reports.

• establish a screening protocol to be used by all six birthing hospitals and out of hospital births;
• develop a diagnostic protocol to build Centers of Excellence where timely and accurate Diagnostic Follow-up can occur;
• build a strong bridge between these Centers of Excellence and Intervention.

Four of the six birthing hospitals have purchased the OZ Screening Information and Management System (SIMS). This system effectively tracks the screening results of all infants in the data-base. It enables the user to sort information based on screening results, when the screenings were completed and prints out automated letters to parents of infants in need of follow-up testing. This grant will permit the state to purchase an OZ system for the two hospitals that do not have any system, as well as the special interest groups outside the birthing hospitals. It will also enable the program to acquire a reader station to centralize all of the birthing facilities at a centralized location. The IMS staff has been working with the OZ manufacturers and integrating the data systems is a reality. Thus meeting another of our established goals of ensuring the goal of 100% first time screening and 95% of all referrals return for follow-up screenings. Christiana Health Care Systems has agreed to integrate the hearing screens from the birthing center and Amish/Mennonite screens until such time the central office at DPH can purchase.

Once the remaining two birthing hospitals, the two special interest groups and the Children's Hospital have purchased the OZ Data base, all data systems will be linked to the State's main Reader Station to be located at the Program Office. This Reader Station will be managed by a new hired position, the Program Coordinator. The transmission of this data will be assisted by each of the coordinators at the Birthing Hospitals and Centers and coordinated by the Statewide Program Coordinator.

Each facility needs to have in place an effective referral system. Four of the six birthing hospitals currently have a system in place for referral to outpatient facilities of babies who fail the inpatient screening. Statistics indicate that 1-2% of infants referred for follow-up testing fail that screening as well.

ABR Screening is used as the second step in the screening process and if the infant fails that screening, Diagnostic Testing should be scheduled using Tone Burst ABR with Threshold Determination. This testing utilizes the most current technology available. It also provides the most accurate audiologic picture of the infant's hearing loss. This allows the diagnosing audiologist to select the best amplification system available for each individual infant. Prior to completion of the ABR with Threshold, the Audiologist should complete Tympanometry that employs higher frequency probe tone testing. Studies have indicated that the standard 226Hz.low frequency probe tone used in older children and adult testing can yield inaccurate test results in the infant population. If the tympanogram is abnormal, the ABR with Threshold should not be completed and referral should be made to the Medical Home for intervention for treatment of possible middle ear pathology. As soon as medical intervention is completed, the infant should be referred to the Center of Excellence for completion of the Tone Burst ABR Threshold.

Once the ABR Threshold is completed, and hearing loss is diagnosed, the audiologist will again refer to the Medical Home to ensure there is no medical contraindications to amplification. At this time the Medical Home would make referrals to Genetics as well as Imaging Studies to determine if there is any determinable cause for hearing loss. This would meet our goal of ensuring 100% of all referred Delaware newborns have an identified Medical Home. Should a Medical Home not be available, the diagnosing audiologist and Child Development WATCH (CDW) coordinator will collaborate to find a Medical Home for this infant. During the time of medical clearance, the diagnosing audiologist will establish contact with the statewide Coordinator of Hearing Impaired Services who will establish contact with CDW (refer to Appendix D).

Following medical clearance, the Center of Excellence will corroborate ABR Threshold findings with Behavioral Audiometry prior to fitting with amplification. The diagnosing audiologist will use established contacts with various agencies and organizations to ensure that amplification can be purchased if the infant's insurance will not cover the hearing aids, or if the infant's parents are financially unable to make this purchase.

The Centers for Excellence will primarily be housed in the Birthing Hospitals and the offices of Otolaryngologists who apply to be included. Once a positive diagnosis is reached following the above process, the Program Coordinator will ascertain that the appropriate intervention is occurring. State Agencies involved with this aspect are the Department of Education and the DE Health and Social Services.

Families would have the same right to accept or decline hearing screening or any follow-up care for their newborn as they do any other screening, evaluation procedures or intervention. Consent, consistent with the protocol developed between the Newborn Screening Program and the hospitals will be obtained for newborn hearing screening after determining the family or legal guardian have been provided appropriate educational materials and have had their questions answered by qualified health care personnel. In compliance with federal laws, mechanisms will be established to assure parental release and approval of all communications regarding the infant's test results, including those to the infant's medical home and early intervention coordinating agency and programs.

DIHAIP is acutely aware of a need for additional education among our professionals and our parents. Many regional facilities have developed an information packet to be given to parents upon diagnosis of hearing loss. The State of Delaware will begin incorporating the information in these packets to develop a statewide packet of information that can be given to parents of newly diagnosed infants. This packet will contain information on area educational options and the advantages and disadvantages to each option. It will also provide information on advantages of early identification of hearing loss. This information will be collected from researching various Web pages on the Internet, accessing current information from the Delaware Speech and Hearing Association (DSHA) and several national organizations including the American Speech Language and Hearing Association (ASHA) and the American Academy of Audiology (AAA). This will enable the parents to refer to this printed information as opposed to relying on memory during the counseling process. Experience has proven that relying on memory only cause hardships and disappointments for both the parents and the professionals.

Reports will be generated, as addressed in the goals and objectives, to provide information for program, hospitals, medical providers, CDC, and the Maternal Child Health (MCH) Bureau. The Division of Public Health has a epidemiology team that works closely with the Section, as well as a dedicated MCH epidemiologist, that is currently being recruited to work directly with program, such as this.

Any intended use other than the above stated would have to be submitted to the Human Subjects Review Committee.

Collaborative Efforts

This project has overwhelming support to develop a comprehensive, centralized tracking, integration, and intervention program. Delaware's Universal Newborn Hearing Screening Initiative falls under the auspices of the Delaware Infant Hearing Assessment and Intervention Program (DIHAIP) of the Delaware Chapter of the American Academy of Pediatrics, that officially began May 1999. DIHAIP serves as a statewide steering committee to support the establishment of a universal infant hearing assessment and intervention program for all infants born in Delaware. The committee includes representation from the community, including two parents of deaf children, Public Health, Child Development Watch, Medicaid, Department of Education, representatives from the six birthing hospitals, and AI duPont Hospital for Children, and other experts in the field of audiology. The committee chair has secured funding for interpretation for deaf committee members; however, to date a deaf committee member has not accepted recruitment. This committee not only provides recommendations and direction for the state agencies, hospitals and other agencies, but also is the forum to address concerns from parents and professionals concerning the Early Hearing Detection and Intervention (EHDI) process. The Delaware Universal Newborn Hearing Screening Initiative.

The newborn metabolic screening program currently works collaboratively and coordinates care and resources with the appropriate hospitals and/or medical providers within the state or region. Delaware Health & Social Services, being the lead agency for the Metabolic Newborn Screening Program, Birth Defects, Immunizations, Part C of the Individuals with Disabilities Act (IDEA), and Child Care, is in an excellent position to take the lead in the development of an Early Hearing Detection and Intervention and Tracking, Research, and Integration (EHDI) Project. The project can then be linked to early intervention services provided through Part C to assure needed access to diagnostic and habilitative services for these children. Additionally, improved tracking and case management will result in these children realizing their full potential. The directors for MCH and CSHCN are within the same section as this program and the proposed hearing program. Referrals and follow-up with agencies including Head Start and the Education program occur through the Part C program. With the hearing component added to the case management follow-up will be documented, reviewed, and remain open as long as services are indicated.

Delaware is bordered by Maryland, Pennsylvania and New Jersey. Currently, no reciprocity between the states is occurring with respect to Newborn Hearing Screening. We have recently begun a network with these neighboring states to make contact with Directors of their State programs to begin mapping out a path toward shared information. A goal is that by year 3 or 4 of this grant, we will have established a protocol whereby all infants who reside in Delaware who are born in a neighboring state will have data in our State's centralized data base system. The reverse will be true for those infants born in Delaware who reside in the three neighboring states.

As noted in the Methodology section, Centers for Excellence are in the process of being developed. Collaboration and support for this is through the EHDI committee, representing all of the birthing hospitals and specialized groups.

Another resource for our children is the AI du Pont Hospital for Children in New Castle, the DE specialty referral hospital that performs inpatient and outpatient testing of children who have failed their initial screening at the birthing hospitals and provide follow-up. They have identified the need to purchase an OZ Data Base to be incorporated into the State system of tracking and have included it in their budget.

Evaluation Plan

As with the current Newborn Screening Program and developing Birth Defect Program the Quality Assurance Reports will be monitored for the benchmarks to be established through the Delaware Infant Hearing Assessment and Intervention Program and the Newborn Hearing Screening Staff. This group will also develop the standards and guidelines for the program. An intrinsic part of any UNHS program must be that of quality assurance. When EDHI has been established and each hospital has the same data collection technology it will be relatively easy to track and compare the various hospitals. These comparisons can be with each other and with national benchmarks established by various organizations. Not only can we determine the activity, accuracy and pass rate for each hospital; but we can also determine this same data for each provider/screener.

Staffing and Management System

The people directly involved with the everyday functioning of the Program will be the Project Director, the Audiologist, and the Program Coordinator. The hearing program will integrate with the existing metabolic screening program, as noted with a 99.7% compliance with first screens. The program has been in place for more than 20 years and the staff has longevity with the program. The staff would increase with the addition of a Social Service Coordinator (1 FTE) to lead the hearing component. However, the staff will be crosstrained to ensure seamless program functions. The main duties of the key individuals include:

Project Director will:

• provide oversight for the grant by supervising the Project Coordinator and reviewing progress on each goal and objective;
• accept responsibility for the proper accounting of the budget;
• seek any support necessary from Division, Section and Branch Directors;
• assure coordination of activities with other CHCA activities;
• help develop all the protocols needed for the smooth operation of the program.

The Audiologist: will:

• visit each of the Centers of Excellence, Birthing Hospitals, the Birthing Center and the Amish midwife to ascertain the correctness of the screening process;
• answer questions about equipment;
• arrange for on-site training of personnel who will use the OAE, ABR, OZ Data Base;
• arrange for and conduct educational sessions for families, health care providers, insurers and policy makers.

The Project Coordinator will:

• manage the overall EHDI program;
• manage the data base;
• produce data reports to include outcome data and quality assurance for internal and external use;
• submit annual reports to CDC;
• accept responsibility for the tracking of babies who fail the first screen;
• communicate with families who require another screen, as well as those, who require appointments for diagnosis;
• coordinate the follow-up on babies involved in early intervention.

The IMS team will:

• develop the screen for the hearing information;
• link the hearing data to the existing metabolic screen program;
• maintain and revise the data system as requested;
• develop and/or support the data system to link with the medical providers

Both the Audiologist and the Program Coordinator will serve on the Delaware Infant Hearing Assessment and Intervention Program Team.

Organizational Structure and Facilities

The program will be part of the Division of Public Health, Community Health Care Access Section, within the Women's & Reproductive Health Branch. The Division Director and Section Chief are Primary Care Physicians, and the Branch Director is a Family Nurse Practitioner. There is also a Genetics Medical Director (.5FTE) that is contracted to work with the metabolic program, as well as a full time Genetics Counselor that works within the Branch. There is dedicated space within the metabolic/birth defects program for the expansion to include the hearing staff. As indicated, the staff will expand to include one full time coordinator and a contractual audiologist. One of the audiologists that has helped with the outline of the program and is on the EHDI team has expressed an interest to join the program once established. Organizational chart APPENDIX

The following quality indicators, which have been identified by the DIHAIP, should be tracked at each site as well as Statewide:

NEWBORN HEARING SCREENING will be delineated by site and aggregate data to include:

Number and Percentage of:

• infants screened during the birth admission
• infants screened before one month of age
• infants failing the birth admission screen
• infants returning for follow-up testing
• infants referred for diagnostic evaluation
• families refusing screens

Number and percentage of:

• Infants with coordinated care in medical home
• Number and percentage of infants tested by three months of age
• Number and percentage of infants diagnosed with deficit by three months of age
• Number and percentage of referral sites with recommended appropriate evaluations
• Number and percentage of families refusing evaluation
• Number and percentage of families lost to diagnostic testing
• Mean and median age at diagnostic testing

Number and percentage of:

• infants enrolled in family centered intervention program before six months of age
• Number and percentage of infants achieving their IFSP
• Number and percentage of facilities having the required technology for appropriate diagnosis

The project coordinator will be responsible for developing and distributing surveys and collecting and evaluating survey information. These surveys will be modeled after those surveys provided on the EDHI website. The outcome of the survey tool will help guide the education, resource development and enhancement and guidelines.

Periodic feedback visits between program and hospital designated representatives will occur at each birthing hospital to identify issues and problems within the hearing screening program. The quality assurance visits will be modeled on the highly successful metabolic newborn screening program QA visits.

To document the numbers of newborns screened during birth admission, data will be collected using the OZ System. This will provide the percentages of numbers screened versus numbers born. Since the hearing screen will be linked with the current metabolic newborn screen program which is verified by birth certificates, those infants missed for hearing screen will be identified. The OZ System will flag those who have failed the first screen and the program coordinator will determine the numbers who report for a second screen. The coordinator will calculate the percentages from these numbers who were referred for a definitive diagnosis on a quarterly basis. The program coordinator will document the percent of infants with confirmed hearing loss who will receive early intervention services by 6 months of age as reported on the follow-up form and via direct contact with the Medical Home and parent. In addition, this coordinator will work with Part C within the established Child Find mechanism to obtain information on enrollment, service and outcomes on infants and toddlers with hearing loss directly from the local service coordinator.

The Division of Public is confident that it has the capability of meeting the goals and objectives for program development to integrate the multiple systems, provide a comprehensive case management program to track and ensure follow-up for infants with abnormal screens. The development of this program will provide newborns, families, and the medical community an integrated, comprehensive newborn tracking and case management system.