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

GRANT ABSTRACT
• Grant Narrative

GRANT NARRATIVE

I. UNDERSTANDING THE PROBLEM AND CURRENT STATUS

1.1 Purpose of Cooperative Agreement

The purpose of this project, proposed as a Level I application, is to expand and refine Michigan's current surveillance and tracking system for early hearing detection and intervention (EHDI) through a cooperative agreement with the Centers for Disease Control and Prevention (CDC). In accordance with the objective delineated in Healthy People 2010, Michigan will increase the proportion of newborns screened for hearing loss by one month of age, assure audiologic and medical evaluation by three months of age for infants with positive screens, and assure access to intervention services by six months of age for infants who are deaf or hard of hearing. During the five year project period, full implementation of a sustainable statewide EHDI system including coordination of screening with diagnostic services, family support, medical home, and early intervention programming will be achieved with focus on assuring minimal loss to follow-up. Data linkages will be used to assure development of a timely and comprehensive child health profile for Michigan children including hearing status through the three components of an effective EHDI program (screening, identification, and intervention). The child health profile is a Michigan Department of Community Health (MDCH) initiative planned to benefit both the public health system and health care providers and allows: 1) tracking and surveillance needed to assure that all children in the state receive timely and effective services; 2) provider access to a particular child's profile to determine critical health factors such as immunization status, newborn screening results, early intervention, Children's Special Health Care Services (CSHCS), Medicaid, and Michigan's Child Health Insurance Program enrollments, and 3) assessment of the quality and utilization rates by component programs. The proposed tracking would help to provide comprehensive outcome-driven, rather than categorical, services to children and their families.

1.2 Program Need

Between 1.4 and 3.2 per 1000 infants are born with a significant hearing impairment.^{1 - 2} Thus, as many as 424 of 132,649 newborns in the state of Michigan during 1998 could have been born with a significant hearing loss. The average age of diagnosis of a hearing loss, without a program of universal newborn hearing screening, regardless of degree, and without identified risk factors, is 22 months. The average age of subsequent intervention is 28 months. ² These estimates do not include those newborns who have later-onset or progressive hearing loss. Permanent congenital hearing loss can negatively impact a child's language, literacy, social, and emotional development with lifelong implications. The most critical time for language development is during the first three years of life and the skills associated with either spoken or signed communication are dependent on experience. In addition, recent research has indicated that hearing impaired infants identified and who receive intervention services by six months of age have significantly better language outcomes than those identified subsequently.² Consequently, there is significant need for a timely and comprehensive data tracking system and integration of this system into other data linkage activities in Michigan.

1.3 Program Description and Current Status

Michigan currently has 105 birthing hospitals serving a birth population of between 132,000-133,000 newborns annually. There are 65 hospitals in Michigan currently providing a universal newborn hearing screen program reaching approximately 66% of the annual newborn population. By the end of 2000, it is anticipated that an additional 32 hospitals will implement early hearing detection and intervention programs bringing the percentage of newborns screened and reported to the state database to approximately 90% of all births.

Follow-up status is currently available for approximately 50% of infants who failed the initial hearing screen bilaterally (about 600 newborns) in 1999. Approximately 900 other newborns failed the newborn hearing screen unilaterally for which no active follow-up was initiated. At this time, due to sporadic implementation of screening programs and incomplete follow-up, only .1% of all newborns (133 in 1999) are known to have been diagnosed with significant hearing loss. This includes either permanent bilateral or unilateral conductive or sensori-neural hearing loss. The percentage of these infants with documented intervention services is not available due to the emerging status of the tracking and surveillance system and sporadic assignment of personnel to this task.

The Michigan Medicaid program implemented a policy effective June 1, 2000, that requires all hospitals with 15 or more Medicaid reimbursed births to screen newborns for hearing loss prior to discharge using physiological methodology. Hospitals with fewer than 15 Medicaid reimbursed births will refer the infant to an approved hearing center for the hearing screen within the first month of life. A copy of the respective policies, the most recent listing of programs conducting universal newborn hearing screening and those scheduled to begin in 2000, and a map of Michigan are in Appendix A. Since smaller hospitals are exempt from the in-hospital newborn hearing screening protocol, only 10 of the 105 birthing hospitals will qualify for referral programs. However, many of these smaller hospitals already have implemented in-hospital screening.

The EHDI program database shares a common database with newborn metabolic screening (phenyketonuria, hypothyroidism, galactomsemia, biotinidase deficiency, maple syrup urine disease, sickle cell disease, and congenital adrenal hyperplasia). The newborn hearing screen report form is included in the blood specimen card used by hospitals. Hospital personnel manually complete the required demographic information on the self-carbon blood specimen card that is mailed to the state laboratory for analysis. One page of this card is dedicated to reporting hearing screen results. A sample of the form used for hearing screen results is shown in Appendix B along with the current quarterly summary. Demographic information is currently entered into the database manually by coders in the state laboratory. This information is then available electronically available to the EHDI program where the hearing screen results, diagnostic information, intervention and dates of services are entered manually by a contractual data coder. Funding for the data coder has been provided by Early On®Michigan (Part C of the Individuals with Disabilities Education Act). Funding will not be available after September 30, 2000. The current data fields and codes are presented in Appendix C.

A graduate student staffed an active follow-up pilot project for infants with bilateral failed screens during the summer of 1998. It is currently continued by a part-time audiologist and doctoral level student. The students provide back-up for the hospital notification process to primary care physicians. A bilateral failed hearing screen triggers a facsimile which is sent to the primary care physician noting the need for continued evaluation. The physician is asked to work with the family to assure re-screen and/or audiological diagnostic evaluation and report the results back to the MDCH newborn screening database. If follow-up information is not received, the primary care physician is contacted again approximately one month later. At this time the local Early On coordinator is also asked to initiate the "child-find" component of Early On in order to assist the family in understanding the need for re-evaluation and coordination of services. Confidentiality issues are addressed by parental release of information within the hospital and are governed by the interagency agreement between the MDCH and Michigan Department of Education (MDE), lead agency for Part C activities in Michigan. Hearing loss is also a reportable diagnosis to the Birth Defects Registry established by P.A. 236 of 1998. See reporting forms in Appendix D. Additionally, to encourage follow-up evaluation reporting, audiologists and otolaryngologists have received a reporting form with instructions.

Michigan has several Perinatal Regional Centers that are diagnostic audiology hubs. A map showing these locations is included in Appendix E. These centers are included among the 65 diagnostic audiology practices that have the capabilities to evaluate the very young infant. Many of the centers are also approved providers for Children's Special Health Care Services (CSHCS). A listing audiological sites is in the guidebook, Services for Children Who are Deaf or Hard of Hearing: A Guide to Resources for Families and Providers in Appendix F.

Intervention services for infants identified with hearing loss are available in a variety of settings ranging from independent practitioners to universities and school systems. The level of services available also varies from setting to setting as does the type of language stimulation that is available. Educational program availability is also listed in the Michigan guide found in Appendix F. MDCH is supportive of informed family choice for language development.

There are several tracking and surveillance systems within MDCH and its interagency partners that are important to the development of linkages to improve the hearing screening, identification, and intervention system. Continued linkage with metabolic newborn screening is paramount. The EHDI Program can and should be linked with birth certificates and the Birth Defects Registry in Vital Records as well as with Early On and CSHCS. Linkages currently being developed within maternal and child health, i.e. Supplemental Nutrition Program for Women, Infants, and Children (WIC) and Medicaid, are using the birth certificate as the core system. A description of these systems can be found in Appendix G. Communication with related programs, projects, and tracking systems has already been initiated to determine potential database linkages that will lead to better care for children and increased utilization of services by families.

1.4 Challenges, Barriers, Problems

Because Michigan has implemented a partial program for tracking and surveillance of EHDI, the challenges, barriers, and problems associated with development and implementation have already been recognized. The challenges associated with upgrading and refining the system to facilitate EHDI include:

• Developing and promoting an agreed upon data set for reporting
• Developing a reporting system that is simple and non-intrusive to avert resistance to additional workload
• Working with hospitals and other providers regarding the legal aspects of reporting individualized data to MDCH
• Assuring that hospitals and providers report to the MDCH database in a timely manner
• Minimizing incomplete or erroneous results reported by providers
• Designing a database that will generate necessary outcome reports and allow integration with other systems
• Coordinating with systems that are continually changing status
• Assuring development of a system that will be available to a majority of partners needing information on screening, identification, and intervention components
• Assuring resources to carry out activities necessary to implement the system

II. GOALS AND OBJECTIVES

The primary goal of this project is to expand, improve, and integrate Michigan's statewide surveillance and tracking system for EHDI to assure minimal loss to follow-up for infants and their families while assuring a system that is sustainable over time.

Key objectives that will be undertaken to achieve this goal include:

1. Improvement and expansion of the current data tracking and surveillance system for the EHDI components of screening, confirmation of hearing loss, and early intervention.
2. Integration of the newborn hearing screening database with other child health databases.

All Michigan newborns and their families will be included in this program unless there is a signed refusal for services. Coordinated and linked services are to be provided in a high-quality and cost-effective manner. Parents and physicians are partners in the medical home to assure that services are accessible, family-centered, continuous, comprehensive, coordinated, compassionate, and culturally-competent. Further, service must comply with national standards delineated in Healthy People 2010, the 2000 Joint Committee on Infant Hearing Statement (June 12, 2000), and the 1999 Position Statement on Infant Hearing from the American Academy of Pediatrics (AAP)

In 1998, 132,649 neonates were born; 79% of all infants were white, 18% black, 2% Asian and Pacific Islander, and less than 1% were native American Indian. Michigan also has many Mexican-American migrant farm workers and several hundred thousand Arab, Muslim, Chaldean Americans primarily residing in the southeastern part of the state.

III. DESCRIPTION OF PROGRAM AND METHODOLOGY

The activities of this project will focus on:

1. Continued improvement of the statewide EHDI data management system
2. Improved monitoring of program quality as the database is expanded and data are submitted by all providers statewide for the three components
3. Improved data quality assurance and client tracking based on linkage of hearing database to birth certificate database
4. Developing mechanisms to identify and collect standardized data on infants and children with late onset and progressive hearing loss

During the first three years of this agreement, primary emphasis will be placed on the first three activities, using resources currently available as well as hiring and assigning permanent staff to assist with further development.

3.1 Improving the EHDI Data Management System

Michigan's current data tracking and surveillance system has been described in Section 1.3 of this document. Since the newborn hearing reporting system is linked to the metabolic screening system, timely reporting is occurring because hospitals are accustomed to submitting blood spot samples in a timely manner. Because it is linked to a process that is routine in the hospital newborn nursery, reporting hearing in the same format has not been as burdensome to the hospitals as a new system would have been. The linkage of the metabolic and hearing screens has also provided a quality assurance function in relation to matching each infant's screening status. For example, in some cases, hearing screen results have been received on infants whose blood screening cards were missing. Hospitals are then contacted and asked to submit a blood specimen on the "missed" infant as soon as possible. The benefit of this linkage has confirmed the need to link both of the newborn screens (metabolic and hearing) to the birth certificates to assure that newborn screens are not missed. Another benefit of the hearing screening linkage to birth certificates will be to locate infants born at home or in other situations who might otherwise be missed. Finally, linking hearing screening results with the birth certificate files will provide additional health information to the continuum of maternal, infant, and child health database for program monitoring and epidemiologic analysis.

Linking the EHDI database Maternal Child Health and educational based databases provides an excellent opportunity to locate infants and their families who may be lost at some point within the process from screening through diagnostics and intervention.

The Early On®Michigan Program is located in the Michigan Department of Education and provides coordination of intervention services for families of children with disabilities. The Vital Records and Health Data Development Section within MDCH has conducted a pilot study to link the Early Education Tracking System (EETRK) and the birth defects registry and efforts are underway to establish a permanent system for linkage. In the future, hearing will be included as part of this effort. Collaboration with the CSHCS database for enrolled children will also be pursued as applicable linkages are established to assure cross-review of infants and children who may be in need of services.

In order to further integrate hearing screening, diagnosis, and interventions, discussions with WIC staff will be held. Approximately 50% of Michigan newborns are enrolled in this program. Often families who may not willing to continue with hearing re-evaluation seek WIC services which offers an opportunity to remind families of the need for hearing follow-up. The Michigan Childhood Immunization Registry (MCIR) is also a possibility for linkage as it would afford physicians and health departments an opportunity to monitor family compliance and offer assistance with appropriate referrals and diagnostic appointments.

To begin this process of linkages, we plan to assure that standardized EHDI data are collected including factors required for national reporting (as planned through CDC) and recommended by the Joint Committee on Infant Hearing (JCIH). The items currently included in the Michigan database will be reviewed and compared to recommended measurements and amended to fulfill quality indicators from the JCIH. The Michigan and the proposed national data elements are located in Appendices C and H respectively.

In the first year of the project, activities will focus on preparing the current newborn screening and EHDI database for integration by changing the current FoxPro format to an Access database. Access will allow generation of more individualized reports and is supported by the MDCH Management Information System (MIS). Technical assistance for FoxPro is no longer available. In subsequent years, the Access programming will be interfaced with Oracle software as part of the MDCH project called Vital Vision. The project includes plans to implement a new electronic reporting system for Vital Records.

Simultaneously, coordination with the metabolic newborn screening program and the planned systems changes within the laboratory will be necessary. One of the first steps in the transformation of the database structure expected in Year 2 of the grant is that demographic data and hearing screen results will be scanned for input to the database. This will eliminate the manual data entry as described above in Section 1.3. Until this can be implemented, full-time program staff for manual data entry will still be needed. As this change occurs, manual data entry will be reduced and only data entry of diagnostic results and intervention services for agencies not having access to the Vital Vision software will be necessary. Vital Vision will eventually be an automated electronic system (with electronic data entry) that will complement and sustain a number of activities that are not now feasible due to both technical and staff limitations. It will include software provided by the Department to the majority of providers including hospitals and local health departments statewide. The EHDI data fields will be incorporated into this system during year one through the development of specific software programming. The new Vital Vision system will routinely link all newborn screening data with birth record data to both identify unscreened children and conversely identify newborns whose births were not registered. This new system promises to greatly improve the timeliness of birth reporting from hospitals and serve as a vehicle to significantly improve the collection of health information. These changes are expected to occur over the next five years. Preliminary discussions between the newborn hearing and metabolic programs, Vital Records and MIS have already occurred, and will continue as the new system is implemented.

The demographic and outcome data that will be available through implementation of the coordinated Child Health Profile and Vital Vision will provide additional opportunities for greater analysis and review by Bureau of Epidemiology staff. Coordination with MCH research initiatives can be expected.

Working with collaborative teams within MDCH and workgroups representing hospital, audiology, Early On, and physicians, and with guidance from national technical centers and CDC, mechanisms to identify and collect standardized data on infants/children with late onset or progressive hearing loss will be developed during the third and fourth year of the project. The JCIH provides recommendations on factors that should be reviewed and indicates that the primary care physician should be responsible for assuring referrals. Guidelines for physicians and a mechanism to report children who are at risk for later hearing loss will be developed. Since Michigan's immunization database (MCIR) allows access by physicians for entering and monitoring immunization data, it may be an avenue by which infants and children with high risk factors for later onset hearing loss can be tracked to assure periodic monitoring and intervention services as needed. Discussions with MCIR staff regarding implementation, confidentiality, and other issues will be scheduled.

3.2 Improving Programmatic Quality

The existing EHDI database format offers good information about areas in need of programmatic improvement. The Michigan EHDI program will compare these data to the recommendations documented in the JCIH, Year 2000 Position Statement relative to benchmarks and quality indicators. A synopsis of these program elements is contained in Appendix I. Quarterly reviews of the entire state and individual hospital reports will be continued particularly in relationship to programmatic goals. In-service presentations and telephone conferences will be held as well as provision of consultation to hospitals and other providers experiencing difficulty with meeting specific benchmarks. Consultation meetings are currently held on-site for programs preparing to implement submission of data.

To improve the system for referrals from failed hearing screen to audiological diagnosis, MDCH, in collaboration with the Michigan Association for Deaf, Hearing, and Speech Services' (MADHS) sub-committee on infant hearing, will chair workgroups with relevant stakeholders and parents/consumers. The purpose of the workgroups will be to develop appropriate protocols for all three components of the EHDI program. State recommended protocols for hospital screening, diagnostics, audiologic and medical evaluation, genetics, intervention, and family support services will be formulated. The protocols will be introduced at regional meetings held for all appropriate stakeholders during the second year of the project period..

Focus groups with Early On representatives and their partner agencies have already taken place. These groups identified a need to provide information to expectant parents in prenatal classes about newborn hearing screening, the importance of seeking follow-up, and information on speech-language-hearing milestones.

3.3 Prepare and Publish Manuscripts

The MDCH collaborative divisions as well as other partners will prepare manuscripts and articles that will describe the development of the tracking and surveillance system . Manuscripts will include definitions, methodology, relationships with other divisions and agencies, data collection, outcomes, and recommendations that would be helpful to other states and territories. Articles will be submitted to appropriate professional journals for possible publication. This would likely occur during the third through fifth years of the cooperative agreement progression.

MDCH will seek technical guidance from CDC to facilitate this aspect of the cooperative agreement.

PROJECT ACTIVITIES TIME ALLOCATION TABLE (YEARS 1-5)

Project Title: Cooperative Agreement for Early Hearing Detection and Intervention Tracking, Research, and Integration with Other Newborn Screening Programs

Project Director: Douglas Paterson State: Michigan

Project Co-Coordinators: Elise Dimon and Katherine Miller

Documentation describing staff to complete this project are included in Section 6.2 and 6.3 on following pages. An allocation timetable is also included in Appendix J.

IV. EVALUATION PLAN

4.1 Performance and Outcome Measures

The key measures of project success will be documentation showing statewide performance data for the following criteria taken from the JCIH, AAP, and Healthy People 2010:

The MDCH-EHDI statewide database will be used to analyze outcome data for the state as well as individual hospitals. The quarterly and annual reports will be analyzed for statewide, regional, and county variations as well as areas of strengths and weakness. Our MCH epidemiologist, Dr. Zhu and Katherine Miller, Director of the Data, Evaluation, and Surveillance Unit in the Division of Family and Community Health (DFCH) will collaborate with this analysis. In addition, hospitals will receive information on infants for whom re-evaluation data have not been obtained as reinforcement in the need to work with local physicians and families on assuring follow-up. Other providers such as audiologists and early interventionists and advisory committees will also receive feedback showing state attainment of the performance and outcome measures.

4.2 Process Evaluation

Process evaluation of the stated goal, objectives, and activities will also occur as itemized in the Project Activities Time Allocation Table in Chapter III, Program and Methodology.

4.3 Questionnaires

In order to assess the plans and activities of the statewide EHDI program, we will call upon the resources of the National Center for Hearing Assessment and Management (NCHAM), CDC, and CDC national technical site Level II awardees as well as our own Parent Participation Program (CSHCS) and Advisory committee to assist us in developing consumer and health intervention and early intervention provider surveys regarding satisfaction and knowledge in the areas of screening protocol, assessment, early intervention, coordination of services, communication needs, and family support. Development of the surveys will also include persons of diverse ethnic and cultural backgrounds to assure appropriate queries. The surveys will be conducted during the initial, mid, and final years of the project period in order to obtain feedback for improvement.

V. COLLABORATIVE EFFORTS

Michigan has been collaborating with hospitals, diagnostic centers, and intervention services since the beginning of its initiative. This can be evidenced via the reporting system that is described in this document and from assurances contained in letters of support in Appendix K.

5.1 Intra-departmental Coordination

The EHDI program is directly linked to newborn metabolic screening. As Newborn Screening expands and linkages with other programs are planned, EHDI will be included. Through this collaboration, other links to provide facilitated tracking and surveillance activities and assure follow-up success will be explored. A listing of possible collaborative partners is outlined in Appendix G.

The Maternal Child Health data workgroup focuses on coordination of data linkages, encourages the utilization of data for MCH programs, and reviews and promotes research studies on MCH issues. The workgroup includes staff from the WIC Program, Medicaid, Vital Records, Epidemiology and the Division of Family and Community Health. The Hereditary Disorders and Newborn Screening Program was recently added as will EHDI be included in this group as part of the present proposal. A listing of current membership, mission, and goals of the workgroup is attached in Appendix L.

5.2 Advisory Committees

Existing committees such as the Community Living, Children, and Families (CLCF) Advisory Committee will be asked to participate in needs assessment and periodic review of program progress, intra-department systems development, and outcomes. A sub-committee of this group will be requested to assure appropriate representation from families, deaf and hard of hearing consumers representing Deaf Culture and an oral-auditory or total communication language approach to stimulation, hospital screening and administrative personnel, physicians, audiologists, speech-language pathologists, early interventionists, genetics counselors, and special educators for children who are deaf and hard of hearing. This advisory committee will also be instrumental in providing practical suggestions for collecting standardized data on infants and children with late onset or progressive hearing loss. A description of this body is in Appendix M.

5.3 Partner Organizations

The Michigan Association for Deaf, Hearing, and Speech Services (MADHS) is a Michigan-based consortium of advocates, providers, consumers, and families who meet monthly regarding a wide range of issues for people who are deaf and hard of hearing. A sub-committee for infant hearing also meets and provides input to MDCH regarding EHDI. Listings of consortium members and sub-committee members are contained in Appendix N.

Individuals from the Family Support Network (part of the Parent Participation Network of CSHCS) and families enrolled in Early On are also starting to collaborate on development of a family-to-family network specific to families with children who are deaf or hard of hearing. This type of program development will provide parent-to-parent consultation when families need to understand the importance of timely assessment. It will also help to assist families when there is a new diagnosis of hearing loss in the family and questions abound. This type of collaboration will not only assist families, but will also provide a mechanism to obtain feedback from families about their experiences with the newborn screen, diagnostics, and intervention.

MDCH will also collaborate with Early On when infants and their families have not been contacted after a failed hearing screen and when a family needs further service coordination during the assessment stage or when there is a diagnosis of hearing loss. CSHCS in this state is a payor of last resort for diagnostics and other services for over 2500 diagnoses including hearing loss. CSHCS has implemented a program expansion to stress the concept of the medical home for children with special health care needs. Enrollment in CSHCS is determined by diagnostic eligibility, not financial status.

The Carls Foundation, a philanthropic Michigan based organization with special interests in speech-language and hearing related issues, has also provided mini-grants for partial support of audiological screening equipment to hospitals to initiate EHDI programs. In the initial period of program implementation, CSHCS and Early On had also provided similar mini-grants that were administered through the Michigan Health and Hospital Association.

5.4 National Technical Advisory Centers

The MDCH EHDI Program will work cooperatively with CDC to assure a quality data surveillance system for the three components of EHDI. Our information package to hospitals implementing programming has included the Health Resources and Services Administration and Maternal and Child Health (HRSA/MCHB) guide, Implementing Universal Newborn Hearing Screening Programs In addition, we will seek technical assistance from the NCHAM and the Marion Downs National Center for Infant Hearing (MDNC) to tap areas of expertise. Other services and resources such as the National Institute for Deafness and Other Communication Disorders will also be valuable for sharing ideas, especially regarding epidemiological factors. Level II awardees for this cooperative agreement may also provide leadership.

VI. STAFFING AND MANAGEMENT SYSTEM

The MDCH has the programs and the majority of personnel to carry out the proposed

project. In addition to experienced hearing and newborn screening personnel, there are qualified staff working in other areas relevant to the project including maternal and child health, children with special health needs, vital statistics, and epidemiology who are interested and willing to share their expertise.

6.1 Background

The initiative for EHDI began in 1996 under the Division of Children's Special Health Care Services within which audiology, the Hereditary Disorders Program (HDP), and the Newborn Screening Program were then located. MDCH has had a newborn screening program since 1965 when a reliable test for phenylketonuria (PKU) first became available. Public Act 14 of 1987 expanded the program and designated a central laboratory, added comprehensive follow-up medical management centers, and quality assurance. The HDP was originally established in 1978 as a result of the National Genetic Diseases Act with funding through the HRSA/MCHB and is now maintained by state funds.

6.2 Experience

Douglas Paterson, MPA, Administrator of the Division of Family and Community Health, is the principal investigator for this project and has more than 20 years of public health managerial and administrative experience. Mr. Paterson is responsible for the Early Hearing Detection and Intervention Program and has great interest and support for this developing program within his division which manages the majority of MCH programs for MDCH.

Elise Dimon, MS, CCC-A, FAAA, co-director of the proposed project and Coordinator of the EHDI Program within the Division of Family and Community Health (DFCH), has had extensive experience as a clinical audiologist and experience in newborn hearing screening. She is a long-time advocate for hearing screening for newborns. Ms. Dimon has coordinated meetings for hearing screening, presented at educational conferences and in-service trainings, developed program materials and publications, and developed and maintained contacts with partner organizations and agencies. She also has extensive knowledge about services covered via Medicaid and the CSHCS Plan. Ms. Dimon will continue her role as Coordinator of the EHDI program in Michigan and as co-director of the present project.

Katherine McGrath-Miller, MA, is co-director of this project, and director of the Data, Evaluation, and Surveillance Unit in the Division of Family and Community Health (FCH). She is the chairperson of the MCH Data Workgroup and coordinates MCH programming with the Epidemiology Division. Ms. Miller has worked in several MDCH programs over the past fifteen years and has considerable skill in collaboration and intra-departmental communication. Ms. Miller's role in this project will be to assure the collaboration with appropriate databases to ensure that EHDI goals and objectives are attained.

William Young, Ph.D. currently directs the Hereditary Disorders and Newborn Screening Unit and has been with the department since 1979. His experience includes thirty years of public health genetics and newborn screening program development. He serves as co-investigator with the Deputy Registrar for Michigan's cooperative agreement with the CDC for enhanced state-based birth defects surveillance and provides oversight to several aligned programs, including the HRSA/MCHB Planning Grant for Infrastructure Development and EHDI currently being developed.

Glenn Copeland, MBA, Deputy Registrar, is director of Vital Records and Health Data Development Section in the Division of Vital Records and Health Statistics. He has been with MDCH since 1973 and has extensive experience in the development and management of public health data. Mr. Copeland has developed data linkage and matching routines for numerous applications for recent pilot studies to match the Birth Defects Registry (BDR) cases with Department of Education, Early On data files as well as newborn screening with birth certificates. He has also indicated willingness to establish the same types of links with BDR, birth and death certificates, and Early On to assure greater success in follow-up services and quality assurance to screening programs.

Bao-Ping Zhu, MS, PhD, MD, the State Maternal and Child Health Epidemiologist in the Epidemiology Services Division, is involved with numerous MCH projects and will provide epidemiological expertise to this project. Dr. Zhu is a CDC epidemiologist under contract between CDC and MDCH.

The Management and Information Systems (MIS) Division within MDCH also has extensive experience and knowledge about the developing program, Vital Vision, that will be an interfacing system of all programs and databases within the MDCH and all corresponding providers throughout the state and nation. In this capacity, this Division will provide guidance to EHDI and newborn screening in upgrading technology to easily interface with the Department's plans for data tracking and surveillance.

6.3 Other Participating Staff

There are a number of other individuals have shared information and will provide continued expertise to this project. Jacqueline Scott, DVM, PhD, is director of the Chemistry and Toxicology Division which encompasses the newborn screening laboratory. Dennis Dodson, MS, manager of the Population and Provider Data Unit within Vital Records is directly responsible for the daily management of the BDR He has considerable statistical expertise and experience with the broad issues related to data management and quality assurance and has staff with expertise in abstracting. John Naber, MS, JD, is Coordinator of the Newborn Screening Program (metabolic screens) and has been instrumental in assisting with maintenance of the FoxPro database and generating reports for the EHDI. Lisa Cook-Gordon, MA, Early On®Michigan liaison in the Division of Family and Community Health has worked closely with EHDI and will lend assistance to assuring further collaborative efforts with the Michigan Department of Education.

VII. ORGANIZATIONAL STRUCTURE AND FACILITIES

7.1 Organizational Structure

The proposed MDCH project will be conducted by the EHDI Program and the Data, Evaluation, and Surveillance Unit within the Division of Family and Community Health, CLCF. An organizational chart is attached as Appendix O. The project will depend upon cooperation across administrations, bureaus, and departments indicated in the following chart.

7.2 Facilities

The program is physically located within the space designated for the DFCH. The co-project coordinators, the data coder, and the follow-up consultant all have desktop computers adequate to carry out the proposed project for the current time. Internet and e-mail is available.

VIII. HUMAN SUBJECTS REQUIREMENTS

At the initiation of Michigan's EHDI program, application was made to the MDCH Human Subjects Committee. The project has received MDCH/IRB approval. Form OMB 0925-0418 is included.

1. Mason JA and Herrmann KR. Universal Infant Hearing Screening by Automated Auditory Brainstem Response Measurement. Pediatrics 1998; 101(2):221-228.

2. Yoshinaga-Itano, C. et al. Language of early and later identified children with hearing loss. Pediatrics 1999; 102:1161-1171.