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

GRANT ABSTRACT
• Grant Narrative

GRANT NARRATIVE

1. Understanding the Problem and Current Status

   The Iowa Department of Public Health (IDPH) is applying as a Level I eligible applicant and currently implements a newborn hearing screening system in Iowa. Iowa has worked diligently over the past seven years to establish a voluntary newborn hearing screening system. Eighty-one of ninety-four hospitals with a birthing center provide newborn hearing screening services. IDPH has not been alone in advocating for universal newborn hearing screening. A 28E Agreement (Appendix A) has existed for five years between IDPH and University Hospital School (UHS) of the University of Iowa (UI), which is Iowa’s University Affiliated Program (IUAP). UHS audiology staff has the expertise and experience in running large scale hospital newborn hearing screening systems and state level systems. In addition, their expertise in pediatric audiological services is nationally recognized. Thus, this partnership between IDPH and UHS has created the Iowa Early Hearing Detection and Intervention (EHDI) "system". The activities of Iowa’s EHDI system accomplished to date, planned for and presented in this application all correlate with the ten essential core public health services. The activities exemplify inter- and intra-agency collaboration of state departments and programs at the public and private level.

   For close to a decade the IDPH has advocated for newborn hearing screening to occur in Iowa hospitals for all newborns, prior to discharge, as a routine objective screen. This CDC grant application for Iowa will enhance and accelerate the necessary planning and implementation time needed to achieve the system results desired. The proposal goals and objectives expand and strengthen Iowa’s current EHDI system. Additional EHDI system components that need to be addressed include training of screeners and providers to work with families in a culturally competent and family centered manner and enhancing public awareness, including physicians, on the importance of newborn hearing screening. Documents such as Healthy Iowans 2010, Healthy People 2000 and 2010 have included newborn hearing screening as an activity worth measuring both in terms of process and outcome.

   The most recent estimates of the prevalence of congenital hearing impairment, available from states such as Rhode Island and Texas are about 2.5 per thousand. From these estimates, Iowa should have approximately 277 children aged 3 to 5 and an additional 277 children aged 0 to 3 identified as having permanent hearing loss based on an average of 37,000 annual births. It is a logical assumption that some of the hearing impaired infants and toddlers have not been identified and/or entered into early intervention services. According to early intervention (IDEA Part C) Federal Data Tables for December 1, 1999 as reported to the Office of Special Education Programs, Iowa has 113 infants and toddlers (0 through 2) and their families receiving audiology services as recorded on Individualized Family Service Plan. Data available from 1998-99 End-of-Year reports from Iowa’s Area Education Agencies (AEA) indicate over 137 preschool aged children are identified with moderate, severe or profound hearing losses.

   EHDI activities represent a population based activity as recognized by the Maternal and Child Health Bureau (MCHB) and the Centers for Disease Control and Prevention (CDC). EHDI is an excellent example of an early identification activity that can lead to extensive community capacity-building. A successful family-centered, community-based, coordinated health care and human service system requires data and resource integration. This cooperative agreement program for Iowa’s EHDI system will expand upon existing efforts by the IDPH to integrate data systems for newborn and child health issues.

   Iowa’s EHDI system is currently working to provide a data management and tracking system accessible to Iowa hospitals participating in newborn hearing screening. Implementation of a statewide system for reporting of screening results and timely follow-up has been more sporadic. It is not known how many newborns in the state have actually had their hearing screened, how many of those referred returned for follow-up, how many were ultimately diagnosed as hearing-impaired, or at what ages they received amplification and entered early intervention. In addition, the established newborn hearing screening system runs independently from all other state newborn screening programs in hospitals, such as the state metabolic screening program.

   Few funds have been committed to this effort in Iowa, yet the system for screening is in place for the majority of Iowa families with newborns. The IDPH, UHS, Area Education Agencies (AEAs) under the Iowa Department of Education, many Iowa hospitals with birthing centers, and Child Health Specialty Clinics (CHSC) Iowa’s Title V program for children with special health care needs have all worked together to develop Iowa’s newborn hearing screening system. The system components that are in the planning and development stages include referrals, follow-up, diagnostic evaluation, development of a treatment plan, timely entrance into early intervention services (IDEA Part C), and linking with a medical home. While these system components are being addressed, there is no standardized manner in which they are approached across the state.

   Initial funds for the implementation of universal newborn hearing screening in Iowa were provided by the Iowa Department of Education (IDE) to IDPH utilizing Part C federal funds from the Individuals with Disabilities Education Act (IDEA). IDPH contracts with UHS to provide training and technical assistance to Iowa’s birthing hospitals to screen all newborns’ hearing and to establish, host and maintain a state wide data management and tracking system on IDPH’s behalf. This activity was coordinated through the office of the director for Iowa’s Maternal and Child Health Title V Block Grant and with the technical assistance of IDPH’s Part C Early Intervention Technical Assistant in that office. In April 2000, Child Health Specialty Clinics (Title V CSHCN) was awarded a Health Resources & Service Administration (HRSA)/Maternal and Child Health Bureau (MCHB) Improvements Project grant to assist with multiple components of an EHDI system for Iowa. This grant provides $100,000/year for four years.

   The EHDI system includes a network of hearing health care professionals from Iowa’s AEAs who have set up a training system in hospitals. Each of Iowa’s 15 AEAs (Appendix B) employs between two and twelve audiologists to provide educational audiology services to children ages 0 to 21 years. In two AEAs private practice audiologists in the community have also provided audiological support functions for newborn hearing screening.

   By January 1998 universal newborn hearing screening programs existing in hospitals accounted for 76% of all hospital births in Iowa. A map of all Iowa hospitals with birthing centers indicating EHDI status is located in Appendix C. Spreadsheets (Appendix D) of all birthing hospitals including EHDI program details and screening data that have been submitted. Sharing of data has been a problem for some hospitals based on their method of data recording and tracking, so this data set is currently incomplete. Of the 18,518 infants born in 1999 on whom screening data were reported during the varying data collection times (Appendix D), 17,411 (94%) had their hearing screened. This is not a high miss rate (6%), but efforts should be made to reduce it. IDPH anticipates that the miss rate will decline in these programs as hospital staff become more accustomed to incorporating hearing screening into their daily routines. IDPH intends to work toward, not only universal screening, but universal reporting, to accurately assess the percentage of Iowa newborns who have their hearing screened. There is also a need for more accurate accounting of numbers of live births and transfers of newborns between hospitals.

   Iowa’s EHDI system faces multiple challenges and barriers for further expansion. Appropriate screening equipment continues to be a concern for program expansion. Using IDEA Part C funds competitive grant awards were awarded by IDPH to 35 Iowa hospitals in September 1998 in the amount of $2000 each to assist in the acquisition of newborn hearing screening equipment. In addition, interpreting current data is difficult because hospitals do not use consistent time periods to report data. The reporting times can vary from 1 month to a year, depending on when their program started and if they have had any complications. The following EHDI system issues can be addressed effectively through the CDC and MCHB grant: training of screeners; installation and maintenance of the state data system (Screening Information Management System, SIMS software by OZ Corporation in Texas) by hospitals and AEA audiologists; home births; billing consistency and reimbursement rates; and connection to Iowa’s State Children’s Health Insurance Program (SCHIP).

   Screening hospitals in Iowa vary in practices regarding informed consent from parents. Some hospitals, generally level III perinatal centers and some regional level II centers, report that newborn hearing screening is considered a standard of care or is a standing order from physicians. These centers do not obtain parent consent for screening. Other hospitals, generally some level II and all level I centers, do obtain individual parental consent to screen and to share screening results with the AEA on behalf of the state system. It is recognized that there is a tremendous need to standardize consent procedures for screening and release of screening information, and it is an EHDI system goal. In addition, issues related to billing and reimbursement by all third party payers, including involvement with Iowa’s SCHIP will be addressed through the HRSA/MCHB Improvements Project grant activities.

   Practices in the state also vary with respect to screening procedures. The hospitals employing staff audiologists as screening program managers have developed their own screening protocols. Among other screening programs, screeners are obstetrical nurses and screening protocols have been developed by private or AEA audiologists with whom they consult. However, the two state quality assurance technical assistants contracted through UHS, with direction from IDPH, are working with all hospital screening programs to reach uniform standards across screening programs.

   In many cases, parents of newborns who fail screening are asked to return to their local AEA audiology office or birth hospital for a free rescreen for their infants at ages 2 to 6 weeks. This service is provided by AEA audiologists or obstetrical nursing staff with IDEA Part C federal funds or Part B special education funds. After this rescreen, newborns who are still in need of a diagnostic audiological evaluation are referred to one of eight sites in seven cities that are available in Iowa that can provide diagnostic auditory brainstem response (ABR) evaluations and otoacoustic emissions (OAE) evaluations to young infants. An objective of Iowa’s EHDI system is to collaborate with these eight evaluation sites. Most of these diagnostic audiological services also provide hearing aid fitting to infants and toddlers.

   Linked data create a more complete picture about health status, disease distribution, availability and use of service, and characteristics related to health for newborns and children. Specifically this grant program will allow the IDPH to build off of the work from the HRSA/MCHB Genetics Planning Grant funds received by IDPH in 1999 to accomplish, "A Plan for the Development of a State Genetics Plan and Integrated Data Collection and Service System for Early Identification" (MCHB 99-029). This task force consisted of 13 programs at IDPH and UI. Their recommendations (Appendix E) for the genetics grant recognize the barriers, challenges and continued need for this type of public health data integration to occur in Iowa. The newborn screening and surveillance programs in Iowa will all be involved with this cooperative EHDI agreement. Letters of support from the majority of these entities, representing both newborn screening systems and programs, are located in Appendix N.

2. Goals and Objectives

Goal 1: To provide newborn hearing screening services to all of Iowa’s children and to develop a system to ensure early diagnosis of infant hearing loss.

1. Establish newborn hearing screening programs in all hospitals with over 50 births per year through the continuation of small equipment competitive grants to hospitals.
2. Develop a plan for screening babies born in hospitals with fewer than 50 births per year.
3. Coordinate activities with UHS and CHSC to develop a plan for screening Iowa’s babies born at home.
4. Develop a plan to monitor those infants who pass newborn hearing screening, but have high risk factors for progressive hearing loss.

Goal 2: To develop a system of data management for newborn hearing screening results to obtain accurate state data regarding screening results, diagnostic follow-up, tracking, entry into early intervention, and linkage to a medical home.

1. Continue to issue an agreement between UHS and IDPH for the housing and maintenance of a state wide data management and tracking system for Iowa’s EHDI system.
2. Support UHS staff in providing training and technical assistance to hospital personnel and AEA audiology staff in utilizing the statewide data management and tracking system (SIMS).
3. Provide funds for two regional quality assurance technical assistants in order to expand their hours of availability to hospital personnel.
4. Train audiologists regarding procedures for linkage to a medical home and early intervention services.
5. Train and assist CHSC regional staff [Title V, CSHCN] and child health local staff [Title V, MCH] ensure hearing impaired infants receive early intervention.
6. Provide funds to continue the state data management and tracking system in 2005 if that system is not fully sustainable.
7. Publish state data on progress in lowering the age at which infant hearing impairment is diagnosed and the age at which intervention commences.

Goal 3: To institutionalize a statewide data management and tracking system for newborn hearing screening with Area Education Agencies and diagnostic/evaluation centers in all Iowa hospitals delivering babies in order to collect and share information at all stages of the EHDI program.

1. Develop a plan to support newborn hearing screening data management software to hospitals with annual births less than 50 and to private audiology providers.
2. Establish state data management and tracking system (SIMS) software in Iowa hospitals through UHS’ assistance of IDPH.
3. Analyze the consistency of the use of SIMS in all hospitals, and provide support for increased utilization.
4. Explore the feasibility of establishing a reporting mechanism for diagnostic centers to utilize in providing interventions and status reports on children under age 3 receiving services.
5. Explore a tracking/reporting mechanism for Early ACCESS (IDEA Part C) to report the status of all children under age 3 with a hearing impairment, who are receiving early intervention services.
6. Establish an annual evaluation sub-committee, with representation from the state Newborn Hearing Screening/EHDI Advisory Committee, that will review state wide data to determine the prevalence, incidence and geographic distribution of newborns with confirmed hearing loss.

Goal 4: To coordinate multiple methods for the EHDI system to receive and respond to parent and professional guidance.

1. Develop a mechanism on the EHDI system web site for people to report concerns and successes related to EHDI in a confidential manner in order to improve system components.
2. Collaborate with the state wide family support programs to gain assistance in increasing parent awareness about the importance of EHDI and to assist in collecting and directing parents who have concerns or comments about the EHDI system.
3. Establish a link with professional organizations in Iowa to gain their assistance in collecting and directing parents who have concerns or comments about the EHDI system.
4. Develop a quarterly report on the comments received from parents and professionals and submit it to the state EHDI Advisory Committee for discussion and recommendations.

Goal 5: Establish and implement a data support plan with IDPH Bureau of Information Management to assist EHDI program activities.

1. Provide assistance and support by working with OZ Corporation, UHS, AEAs, and hospitals to develop a data transfer plan.
2. Develop spatially defined database to allow use of Geographic Information Systems (GIS) technology to track EHDI results, and identify screening, identification and intervention providers for EHDI along with other community supports for parents of a child with a hearing impairment.
3. Develop automated processes to review data and claims for Early Periodic Screening Diagnosis and Treatment (EPSDT) in relation to EHDI.
4. Develop automated processes to back-up EHDI state wide database on a regular basis.
5. Develop a plan to assist UHS (via contractual arrangement) in providing technical computer assistance to hospital personnel and AEA audiology staff in utilizing the statewide data management and tracking system (SIMS).
6. Contract with UHS and support its development and maintenance of a state database to monitor the progress of newborn hearing screening in the state in order to provide statewide quality control indicators on IDPH’s behalf.

Goal 6: Work with IDPH Bureau of Information Management to develop a plan to coordinate and integrate EHDI data with other applicable newborn screening programs.

1. Analyze state EHDI database in comparison to birth records from the Electronic Birth Certificate (EBC) to determine screening rates and program effectiveness.
2. Analyze EHDI state database and the metabolic screening tracking system to assure that all babies are screened in both programs.
3. Analyze EHDI state database and the Iowa Birth Defects Registry to follow high risk indicators for specific newborns in both locations as a marker for the other system.
4. Utilize combined data from EHDI and other newborn screening systems to assist in the timely reporting of data for indicators as required by various national organizations.
5. Coordinate with the Iowa’s Census for Deaf-Blindness.
6. Coordinate with the Perinatal Guidelines Review committee members and gain their assistance in reviewing hospital records to extrapolate data as a cross check to newborn hearing screening data.
7. Explore the feasibility of linking newborn hearing screening results to Connexin 26 screening, as outlined in Dr. Richard Smith’s NIH funded research protocol for Iowa.
8. Coordinate with the Iowa Review of Family Assets program that links parents of newborns to community resources following an assessment conducted at the hospital.

1. Description of Program and Methodology

   A time line that identifies resource allocations for each activity of Iowa’s EHDI system as identified in this proposal is located in Appendix F.

   Target Region and Population

   The target region for all program activities will be the state of Iowa, with some

   activities occurring in border areas in surrounding states. Relationships exist in border communities with tertiary medical facilities, including diagnostic centers. The target population for Iowa’s EHDI system are all annual births (average 37,000) in Iowa (hospital and home delivery), infants up to 6 months of age who move into Iowa, and infants/toddlers age 6 to 36 months of age who live in Iowa or move in to Iowa. Iowa is a rural state with 2.85 million people (U.S. Bureau of the Census data). Ninety six percent of Iowa’s population is Caucasian; however, racial and ethnic diversity is increasing. The most notable population change is the increase in Hispanic immigrants. Census estimates show that residents of Hispanic origin increased from 1.2 percent in 1990 to 1.9 percent in 1997. Primary EHDI communication materials for parents are available in Spanish, and translation of materials into other languages will occur as deemed necessary.

   Establish and Implement State Surveillance and Tracking System

   The IDPH’s Bureau of Information Management will provide consultation on all aspects of the EHDI state surveillance and tracking system design, implementation and maintenance, including data analysis and future integration needs. As shown in the data spreadsheet in Appendix D, current available data regarding newborn hearing screening results come from a variety of sources. Data are only available on a state level regarding screening results during birth admission. No aggregate data are available in a systematic form on the rate with which children referred from newborn hearing screening receive diagnostic audiologic evaluations. A major goal of Iowa’s EHDI system as identified in this proposal will be to provide a framework within which these data can be reported. Recently the SIMS software was acquired with IDEA Part C funds through IDPH. Under the state EHDI system of data management and tracking, data are proposed to flow from hospitals to the state system (IDPH) on at least a monthly basis. A hospital may choose to link to both AEAs and the state system as the AEAs are the direct follow up connection in a family’s community. The details of this data transfer system will be further explored and developed, as illustrated on the system organization chart (Appendix G).

   IDPH will keep the information compiled and maintained in the tracking system confidential in accordance with the applicable requirements and provisions of IDEA Part C and Confidentiality of Records (Chapter 642,134). Parents of all newborns will be provided information on the availability of resources and services in Iowa for children with hearing loss. Data obtained by the tracking system that is taken directly from the medical records of a patient are for the confidential use of the IDPH and the persons or public or private entities that the IDPH determines are necessary to carry out the intent of the tracking system. Notwithstanding the above, anonymous statistical information collected under this section is public information. This information will also be collected through the assistance of the Perinatal Review Team.

   Data will also be reported to the national database on Early Hearing Detection and Intervention (EHDI) CDC, the Title V Newborn Hearing Screening Performance Measure, Healthy People 2010, National Institutes of Health, and others as identified.

   Develop Standardized Data Collection and Tracking Methods

   The two quality-assurance consulting audiologists are currently working toward standardized screening methods, monthly data submission, and tracking methods among all sites involved in EHDI in Iowa. Further funding will allow them to dedicate more time to ensure a consistent statewide system of collecting and reporting AABR or screening OAE results, along with a method to transmit data to the state data base and AEA.

   Collect Standardized EHDI Data (including late onset or progressive hearing loss)

   Data collected from hospitals and AEAs will include number of live births that are: screened, rescreened, passed, referred for audiological evaluation, receive audiological evaluation and at what ages, and number receiving hearing aids and early intervention and at what ages. In addition, data will be gathered via SIMS software regarding severity and type of hearing loss and whether it is bilateral or unilateral. The IDPH (state) data management software allows for continued monitoring of children with high risk factors for progressive hearing loss, such as congenital cytomegalovirus, early exposure to ototoxic medications, and family history of childhood hearing loss. These children will often pass a newborn hearing screen, but may develop a hearing loss before parents begin to notice a delay in acquisition of speech and language. Parents will be provided with educational materials to inform them of high risk factors and address these concerns.

    

   Use Data to Obtain Outcome Data

   One of the most important uses of the state data management system will be to monitor screening program quality with indicators such as screening rate, miss rate, and refer rate. While it is recognized that some false positives are necessary in a screening program to ensure program sensitivity to the condition being screened for, newborn hearing screening programs have been characterized by far too many false positives. This is especially true of programs which rely on Otoacoustic Emissions (OAEs), rather than Automated Brainstem Response (AABR). Iowa’s newborn hearing screening programs vary in technology used. The overall state referral rate from reporting hospitals is currently 4%. Given current best estimates from other states of the prevalence of congenital hearing loss of 0.25%, this referral rate represents a high rate of false positives. Data will be used to monitor this rate during attempts at training and retraining screeners.

   Document Parent and Professional Concerns about EHDI System

   To fulfill Iowa’s EHDI system goals of increased public awareness and professional updates, an Iowa EHDI web-site will be developed to provide information to parents about the newborn hearing screening program, the importance of good hearing to speech and language development, the importance of early intervention, and information regarding access to diagnostic and intervention services. Another web-site section will provide a location for feedback regarding concerns of parents and professionals about the system. The comments will be reviewed at least monthly by the EHDI system staff and responses will be provided in a timely manner. The concerns expressed will also be addressed during each quarterly meeting of the EHDI Advisory Committee. The EHDI system goals on family/parent and consumer or professional input will be addressed through advocacy groups (i.e., Parent Training Institute (PTI), Parent Educator Connection (PEC) and the state coordinator of Family Voices), EHDI web page and public service announcements related to the social marketing plan. Support from prominent Iowa parent advocacy groups will also serve to help raise public awareness.

   Collaborate with State Programs & Advocacy Groups: Build EHDI Infrastructure

   Additional efforts to increase the number of hospitals providing universal newborn hearing screening and to support quality assurance needs of the system will be addressed with EHDI system staff and the Perinatal Review Committee. The EHDI Advisory Committee will consist of various organizations, agencies, state programs and advocacy group representatives. The committee, along with the social marketing plan, will help raise general public awareness on the issue of newborn hearing screening and infrastructure needs of the EHDI system. In addition, the committee members will be able to positively affect their constituents, thus impacting a larger professional community.

   Iowa is unique in the nation because of its tremendous progress in newborn hearing screening in the absence of a legislative mandate. The Iowa Speech and Hearing Association (ISHA) and the Deaf Services Commission have expressed interest in pursuing a statewide mandate for newborn hearing screening, surveillance and tracking. Legislation may be critical to continued success of the program and to move into new phases of the screening program regarding follow-up. During the time period, one of the major tasks of the EHDI Advisory Committee will be to assess the need for and feasibility of state legislation to mandate universal newborn hearing screening, tracking, and intervention and reimbursement for costs of the program that are not reimbursable.

   The Title V MCH and CSHCN directors were consulted regarding the EHDI system and this proposal. The outcomes of this proposal will have a direct effect on the newborn hearing screening rate as a National Performance Measure for MCHB. The Title V CSHCN program proposes to encourage the coordination of various early identification and intervention programs. The goal of systematizing statewide efforts is to improve outcomes for infants and toddlers who experience any of a well-defined array of risk exposures. The Iowa Review of Family Assets (IRFA) project is being designed to ensure that new families have access to the advice, education, support, and professional services from which they could benefit. The IRFA program is a computerized family assessment and will become part of the routine health care in hospitals at the birth of a child. Early ACCESS (IDEA Part C) was consulted to help with awareness activities of this child find activity and to assist with training service coordinators to link newborns to the EHDI system.

   Integrate with other Screening Programs

   Significant linkages exist between IDPH programs or other programs providing a newborn screening or child health service (Appendix G). The diagram illustrates the major partners in the system: IDPH Vital Records and the electronic birth certificate; Iowa Birth Defects Registry (IBDR); Iowa Newborn Metabolic Screening Program (INMSP); and Iowa Review of Family Assets. In addition, the EHDI system is working on concrete links between the initial screening information to programs/organizations that serve as intervention sources: early intervention (IDEA Part C), Title V MCH, Title V CSHCN at CHSC, and Area Education Agencies (AEA).

   EHDI staff discussed the exploration of public health infrastructure resources and initiatives for data integration with IDPH’s Bureau of Information Management. Staff from this Bureau, along with the findings from the Genetics Data Assessment and Integration Task Force (Appendix E), determined that the IDPH is currently working on several projects aimed at combining data from internal and external sources into an integrated data system. Some of these projects include web-based programming. One of the major purposes of the EHDI data management system, and a goal of this grant proposal, will be to coordinate newborn hearing screening results with other state newborn screening systems (registries) and systems for Iowa’s children with hearing impairment. Because a large proportion of children with congenital hearing impairment will ultimately be diagnosed with vision impairment as well, coordination with the Iowa’s Census for Deaf-Blindness will be utilized to streamline early access into intervention services for children with dual sensory impairment. Funds will be used to educate screeners and audiologists about the relationships between hearing and vision impairment in infants and referral protocol.

   This CDC cooperative agreement (grant proposal for Iowa’s EHDI system) would support new activities related to the recommendations set forth from the Genetics Task Force and would increase collaborative efforts by the various newborn screening programs. A detailed table of the programs (Appendix H) describes the newborn screening programs, contact person, purpose, types of data suggested for integration, legislative authority and population served.

   IDPH’s Vital Records Bureau have added fields related to newborn hearing screening on the birth certificate and electronic birth certificate. These fields will be implemented in 2003. The new fields will aid quality assurance and most importantly help in reaching at home births and those that might slip through the "cracks" of the health care system.

   The IBDR will be asked to consider utilizing EHDI data to assist in the analysis of aggregate cluster data on family history. In future years of this proposal funds may be allocated to IBDR to assist in this data abstraction. In addition, it may prove beneficial to use the metabolic collection form with the hospital identification number and match this to the EHDI data. This could assist both systems in reviewing the initial count of newborns and help identify those who did not get screened in either program. Premature and other high risk infants may benefit from this process as it could help with time lines and diagnostic follow up.

    

   Prepare and Publish Manuscripts on Project Data/Process

   The EHDI data collected will support the attainment of the Healthy Iowans (HI) 2010 Goal 11-4 that states, "Increase to 94% (the Fiscal Year 2001 target is 85%) the percentage of newborns who are screened for hearing impairment before hospital discharge. (Baseline: Fiscal Year 1998 percentage was 41%.)" Project management staff will submit the results of the EHDI system to audiological and public health peer-reviewed journals. Staff will seek opportunities to present EHDI system proposal implementation information and process/outcome data at professional meetings and conferences. One such presentation is already scheduled for the Fall 2000 meeting of the Iowa Speech and Hearing Association.

2. Evaluation Plan

   Evaluation of this proposal will be under the direct supervision and guidance of the staff and administration of IDPH and contracted UHS staff. Regular monitoring of the proposal objectives time allocation table (Appendix F) will be required. IDPH is committed to evaluating the overall impact of early hearing detection and intervention activities (EHDI) in Iowa, including data integration. IDPH proposes to develop a model system to evaluate the impacts and outcomes of the Iowa EHDI system and to revise programmatic efforts as necessary. The project director’s will work together with IDPH internal and external data systems that relate to the newborn and infant and then share the results and implementation recommendations with other states.

   A combination of outcome and process evaluation methods will be used to measure successful accomplishment of goals and objectives. The ultimate measures of EHDI program impact and outcome are the prevalence of newborn hearing screening prior to hospital discharge, confirmative diagnosis prior to 3 months of age, and entry into early intervention services prior to 6 months of age (if the family so chooses). Since the state of Iowa does not require hospitals to offer the service of newborn hearing screening to all newborns prior to discharge, it is difficult to obtain or expect 100% compliance. However, in the past seven years Iowa hospitals have rapidly established this service and many consider the activity a standard of care. Until a larger percentage of Iowa’s newborns are screened prior to hospital discharge and utilization of a consistent state wide data management and tracking system so that prevalence is more representative, a better measure of program impact and outcome is the percentage of newborns screened and hospitals reporting this activity.

   IDPH will measure the effectiveness of collaborative activities by documenting how the various agencies and programs supporting newborn hearing screening help IDPH achieve program goals and changes in policy. Consultation for data analysis will be sought from the Center for Health Statistics at IDPH and staff from the Bureau of Information Management. All EHDI evaluation reports will be incorporated in reports for Healthy Iowans 2010.

   The addition of newborn hearing screening fields in the electronic birth certificate and metabolic newborn screening will serve as a check for accuracy for aggregate EHDI data from the data management system. Furthermore a cross check with the Iowa Review of Family Assets will help determine if family needs are met. It should be recognized that data in the EHDI data management system will go beyond that gathered during the birth admission. SIMS software will allow for quarterly evaluation of program quality indicators, for the entire state and for individual screening programs.

   Hearing Screening Indicators to Evaluate: Aggregate Data
   1. Screening rate	5. Proportion of misses returning for outpatient screening	9. Number of screening passes with high risk factors for progressive hearing loss
   2. Miss rate	6. Proportion of screening refers returning for diagnostic testing	10. Number of high risk infants receiving audiolgical monitoring
   3. Refusal rate	7. Number of infants identified as hearing-impaired and at what ages	11. Number of infants identified as hearing-impaired in the state EHDI data system and those reported in the Early ACCESS state database as receiving intervention for the hearing-impaired.
   4. Refer rate	8. Number of infants entering early intervention and at what ages

   The impact of public awareness activities on Iowa’s families will be monitored annually by evaluating the number of families refusing newborn hearing screening and visits to the consumer education portion of the Iowa newborn hearing screening website. A family satisfaction questionnaire will be distributed to a random sample of parents of Iowa newborns each May.

   To study the overall impact of all program components over the proposal period, the feasibility of measuring the receptive and expressive language abilities of Iowa’s hearing-impaired four-year-olds annually will be considered in the first year of the proposal. The Language Development Scale from the SKI-HI program will be administered to hearing-impaired four-year-olds from a sampling of AEAs annually in the Fall. Four-year-olds in the Fall of 2000 were born in 1996, when few Iowa hospitals had newborn hearing screening in place and methods for entry into early intervention were not well-developed. Those born in 1999, when screening programs were finally in place for hospitals responsible for 96% of Iowa births, will turn four in 2003, the third year of the proposal. If the EHDI system and this proposal has had the anticipated impact, we expect a steady increase in the receptive and expressive language abilities of Iowa’s hearing-impaired four-year-olds during the course of the 5 year grant period. By the end of the grant period, several of these children should have performance close to that of their normal-hearing peers.

3. Collaborative Efforts

   Many organizations, agencies and programs are in support of Iowa’s EHDI system. Letters of support from EHDI collaborative partners are located in Appendix N. Parents are involved, in varying capacities, with all of the organizations and programs mentioned in this application. Resources between IDPH, UHS, IDE, AEAs and CHSC have been combined and multiple projects have been undertaken for long term results. Comprehensive planning exists between these agencies, including developing joint strategies and measuring success in terms of impact on the needs of those served.

   As a condition of the contract between IDPH and UHS, UHS senior audiologist, Dr. Lenore Holte, will continue to provide the overall direction on the EHDI system in Iowa. Her leadership is in collaboration with IDPH staff assigned to this initiative, Ms. Dawn Gentsch, MPH. Together they address all aspects of the EHDI system, and coordinate all activities. The two quality assurance consultants were hired through UHS for the provision of direct support to Iowa hospitals and AEAs.

   IDPH will work with Title V local contract agencies to assist with follow up, referral and service coordination activities for these hearing impaired infants and toddlers. The Maternal and Child Health Council, an advisory council for the State’s Title V programs, will be consulted. This council includes consumers of maternal and child health services (including services for children with special health care needs) and an array of other public, private, and voluntary organizations concerned with the health and health-related issues of Iowa’s children and families.

   The metabolic screening system and vital records electronic birth certificate system at IDPH will link with this initiative. The Iowa Birth Defects Registry (IBDR) and Iowa’s Census for Deaf-Blindness will participate in the Newborn Hearing Screening/EHDI state advisory council and are committed to developing a plan for data integration. IDPH Early ACCESS staff will provide support and contract management related to the 28E Agreement between IDPH and UHS. Part C technical assistants representing the IDPH and CHSC will collaborate to direct families to care coordination/service coordination resources located within their home communities following the second hearing screens which will also occur in or nearby their home communities. In addition, Early ACCESS staff will continue to collaborate and coordinate their efforts related to the child find activity of newborn hearing screening and EHDI system components. The Early ACCESS State Advisory Council will provide input and support for the EHDI system when applicable. Early ACCESS service coordinators will be trained on how to link with the EHDI system, and Early ACCESS regional coordinators will play a key role in helping to publicize the EHDI program through the interagency representatives at their regional advisory councils.

   The majority of Iowa hospitals with EHDI systems are voluntarily sharing newborn hearing screening data with the state system and are working with AEA audiologists and/or private audiologists. The AEA audiology support system is a major link for families for follow up and intervention services after leaving the hospital, including child find, assessment and evaluation. Most AEAs are assisting hospitals with data interpretation and re-screening or referral for diagnostic evaluations. All eight diagnostic centers for hearing in Iowa are participating in the EHDI system. A complete list of these centers is located in Appendix I.

   CHSC (Title V, CSHCN) offer a variety of services to children with special health care needs and their families. CHSC regional staff will be able to assist in the EHDI activities of follow up, referral, linkages to Early ACCESS, and linkages to a medical home. In some instances it will be appropriate for the regional CHSC staff to serve as service coordinators for these hearing impaired infants and toddlers and their families. High Risk Infant Follow-Up Program services, available in nearly all regional CHSC centers, assess the specialized developmental needs of infants and toddlers who are at risk due to specific biological factors such as low birth weight. The High Risk Infant Follow-Up Program through University of Iowa Health Care, and the three other hospital based programs in Iowa, will be asked to collaborate with this EHDI program. Their involvement will assist with the identification of children who may not have returned for a rescreen and serve as a method to monitor those children who have risk factors associated with late onset hearing loss.

   The Iowa Hospital Association (IHA) will work with all Iowa hospitals to support their continued involvement in this system. Specifically IHA will assist in educating hospital personnel and other medical providers on the methods of seeking reimbursement for EHDI services and to increase the general awareness and importance of providing EHDI as a standard of care.

   Iowa also has a unique opportunity to investigate the value of genetic screening as a complement to physiologic newborn hearing screening. Dr. Richard Smith from the Department of Otolaryngology at the University of Iowa (UI), was recently approved for funding from the National Institutes of Health (NIH) to conduct research on screening for Connexin 26 mutations and the relationship of this screen to newborn hearing screening results. Dr. Smith’s staff will work with staff from the IDPH metabolic screen and EHDI state data management system to screen all newborn blood-spot cards for Connexin 26 mutations. Using a blinded method, the newborn hearing screening results of those babies predicted by the genetic screen to have hearing loss will be compared to the genetic screen. With parental permission, the blood-spot cards of all newborns who fail the hearing screen will be retested for Connexin 26 mutations. Because recent research indicates that all children who are homozygous for this trait will have bilateral sensorineural hearing loss of moderate degree or greater, this genetic testing could prove to be a valuable addition to EHDI programs. Dr. Smith’s lab has also recently identified a newborn who passed the physiologic hearing screen and subsequently became profoundly hearing-impaired by 1 year of age. Thus, the genetic screen could be an excellent predictor of early-onset hearing loss. NIH is fully funding this project, including laboratory expenses, the genetic screen, and the genetic evaluation for identified infants. A letter of support from Dr. Smith, along with a copy of his notification of approval from the UI Internal Review Board, and a copy of his letter of cooperation with the state Hygienic Laboratory, are all included in the Appendix J.

4. Staffing and Management System

   An agreement, with financial remuneration, has existed for five years between IDPH and UHS for the provision of training and technical assistance activities to establish a universal newborn hearing screening system in Iowa. These efforts were expanded in FFY99 to include the establishment and maintenance of a statewide data management and tracking system. CHSC (Title V, CSHCN) has federal funds for some of the newborn hearing screening activities in Iowa. They too have an agreement with University Hospital School to implement the goals and objectives of the grant. IDPH provides the oversight for all of Iowa’s EHDI system components.

   Dr. Lenore Holte is the primary audiologist for Iowa’s EHDI program. She supervises two additional audiologists who serve as regional quality assurance technical assistants to hospitals and AEA audiologists. Ms. Teresa Linde-Fendrich and Ms. Sandie Bass-Ringdahl are experienced in administering large scale newborn hearing screening programs, including the use of the SIMS software. Ms. Mary McIntosh has received extensive computer training and is very capable of coordinating the state EHDI data system. Thus, these four individuals have extensive experience with the use of the SIMS system for abstraction of screening results, tracking, surveillance and research. Bio-sketches for all key personnel involved with this project, including job descriptions, are located in Appendix K.

   The principal investigator for this proposal, Dr. Ed Schor, is a pediatrician well known for his work in preventative child health issues, including brain research. The proposal (project) coordinator, Ms. Dawn Gentsch, has a master’s degree in public health and has been overseeing IDPH’s EHDI system for over three years. Dr. Schor, Ms. Gentsch and staff to be hired will all be housed at IDPH. IDPH Bureau of Information Management have qualified staff to assist with all aspects of this grant as it relates to computer programming, data planning, linkages, management, integration, analysis and evaluation. In addition, IDPH Center for Health Statistics staff has extensive expertise in epidemiological methods, and public health surveillance. In the past twelve months IDPH has employed an additional four epidemiologists with master or doctoral level preparation. OZ Corporation has assured Iowa that they will work with all SIMS software users to provide the necessary computer programming, installation, maintenance, specialized services for report generation and tracking and for ongoing support.

   IDPH has provided a letter (Appendix L) from Stephen C. Gleason, D.O., Director and Appointing Authority for IDPH, stating that the new program coordinator position requested to be supported by this grant, will be filled and maintained. IDPH requires similar assurances from all agencies receiving funds.

   g. Organizational Structure and Facilities

   The IDPH, UHS, CHSC, IDE and Early ACCESS will all contribute various human and non-human resources for this grant application and the overall newborn hearing screening initiative. Specific details of their contributions are outlined in their respective letters of support. IDPH has the legal authority to apply for Federal assistance, and the institutional, managerial and fiscal capability (including funds to pay for non-Federal share of project costs) to ensure proper planning, management and completion of the project described in this application. The Division of Family and Community Health administers the Title V Maternal and Child Health Block Grant and consists of staff who manage the Birth Defects Institute, WIC program, early intervention environmental health, disease prevention, childhood immunization, child care, dental health, rural health and primary care and community services (Appendix M).

   The administrative office for Iowa’s EHDI system is located in the Capitol Complex in close proximity to the State Capitol, in Des Moines, Iowa. The IDPH employs the Family Services Bureau Chief, a Division Medical Director, and twenty professional and support staff who carry out the functions of Iowa’s Title V program. Responsibility for coordinating the program for children with special health care needs (CSHCN) is an administrative responsibility of the FCH division and is under contract with the UI, Department of Pediatrics. CHSC central administrative offices are located at the University of Iowa Health Care. This proximity provides a wealth of tertiary level pediatric expertise which can be shared with CHSC’s central and regional office staff.

   Child Health Specialty Clinics (CHSC), Iowa’s Title V program for children with special health care needs, and UHS, a University Affiliated Program, are all located under the University of Iowa organizational structure. Multiple agreements exist between CHSC, UHS, and IDPH for such things as Perinatal Review Council, High-Risk Infant Follow-Up programs and others. Both IDPH and CHSC are state signatory agencies for Early ACCESS’s interagency agreement to meet federal regulations.

5. Human Subjects Review

All activities of Iowa’s EHDI system involve newborns and their families. Decisions regarding involvement in any area of EHDI will be discussed with the parent prior to implementation. Newborn hearing screening is not experimental in Iowa and it is considered a standard of care by many Iowa hospitals. The EHDI state system does encourage hospitals to obtain consent from parents prior to screening. Human subjects review conducted by the Internal Review Board at University of Iowa has approved the National Institutes of Health study on Connexin 26 as outlined in Dr. Richard Smith’s proposal.