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

GRANT ABSTRACT
• Grant Narrative

A. Understanding the Problem and Current Status

The purpose of the cooperative agreement is to assist Oregon in developing and to further Oregon's development of an integrated EHDI system, and to assist Oregon in developing linkages with other Oregon newborn screening programs.

Current status of/need for a comprehensive EHDI program: By the end of 1999, approximately 27% of Oregon's newborns received a hearing screening test in six hospitals screening essentially all babies born, or in two hospitals providing high-risk screening only. For the same year, only 15 children under six months of age with hearing loss were enrolled in early intervention services. However, with slightly over 46,000 births per year, between 46 and 128 children with severe-to-profound bilateral loss and up to an additional 128 children with mild-to-moderate bilateral or unilateral losses would have been expected.

Recognizing the need to reduce the number of infants with unidentified hearing loss, the 1999 Oregon legislature adopted a bill mandating newborn hearing screening for all babies born in hospitals with more than 200 live births per year, effective July 1, 2000. It did not, however, mandate or fund surveillance or tracking of newborns through screening, diagnosis and enrollment in early intervention. By law, parents may request a waiver only for religious reasons. Additional informed consent procedures will be at the hospital's discretion.

Under this mandate, thirty-nine Oregon hospitals, located in 22 of Oregon's 36 counties and comprising 91% of all births, must provide universal newborn hearing screening. Six hospitals with less than 200 births per year, in four additional counties, are participating voluntarily. Ten small hospitals will not be screening, leaving five counties with no screening

hospital; five counties have no birthing facilities and few births.

By administrative rule, hospitals must make at least two attempts to obtain a passing result on screening tests before referring a baby for diagnostic testing. Some hospitals will make both attempts prior to discharge; some will schedule a return visit in 1-2 weeks. OHD anticipates that between 2400-4200 children will be referred for diagnostic testing during the first year of the program. This number should decline as screeners become more proficient.

Hospitals are required to notify the parents and primary care provider of the screening test results within ten days and must also provide a list of 12 OHD-approved diagnostic facilities to parents of newborns who do not pass the screening, but are not required to arrange directly for diagnostic testing. The responsibility for follow-up falls on parents and primary care providers who, depending on insurance coverage, may have to make the referral. Likewise, the 10 hospitals not providing screening must, by law, provide parents with a list of the 21 facilities offering screening services, but it will be up to the parents to make these arrangements.

OHD, with the guidance of the Newborn Hearing Screening Advisory Committee (see Appendix A-8), has developed a diagnostic testing protocol and identified 12 audiologic facilities able to perform the full protocol, including tympanometry, repeat OAE screening and frequency specific ABR testing; three more are in the process of obtaining the necessary equipment and will be available by the end of the year. Most are located in the Willamette Valley but there are facilities located in all but the far south and southeast.

Diagnostic facilities must provide parents of infants found to have a hearing loss with a list of early intervention (EI) programs. Most audiologists are likely to take an active role in assisting the parents with early intervention intake, but again, the primary responsibility for following through rests with the parents.

Oregon has a long-established system of eight state-funded Regional Programs for Children who are Deaf or Hard of Hearing that can provide early intervention services to children from birth to kindergarten. There are also three private programs that can provide services.

Newborn Hearing Screening Advisory Committee participants and activities: A legislatively-mandated Newborn Hearing Screening Advisory Committee was assembled to advise on the development and implementation of the Oregon EHDI program. The Advisory Committee, meeting monthly since November 1999, includes representatives of the Oregon Department of Education's Office of Special Education, Regional Programs for Children who are Deaf or Hard of Hearing, Oregon Pediatric Society, Oregon Medical Association, Oregon Speech Language Hearing Association, Oregon Association of Hospitals and Health Systems, Office of Medical Assistance Programs (Medicaid), several hospitals, the Oregon Grange, deaf-education professionals, clinical audiologists, Alexander Graham Bell Association for the Deaf, Oregon Association of the Deaf, two private EI programs, deaf adults and parents of deaf children. The committee is chaired by the director of one of the private EI programs.

In an effort to strengthen the current mandate, the Advisory Committee voted to recommend to the 2001 Legislature that newborn hearing screening be expanded to cover all newborns and include mandatory reporting and tracking of individual patients. Legislation will be drafted before the end of 2000 and a formal report will be presented to the Legislature in early 2001.

Lacking mandatory reporting, OHD has added questions to the Pregnancy Risk Assessment Monitoring System (PRAMS) survey to assess the actual frequency of hearing screening and the percentage of referred infants who have received diagnostic testing by the time mothers complete the survey. OHD will use the PRAMS data to drive policy, presenting the information to the Legislature in support of the recommendations of the Advisory Committee.

Potential for linkage with relevant tracking and surveillance systems: The Center for Child and Family Health (CCFH), responsible for implementing the EHDI program, has already initiated discussions regarding integration of data systems. In April, representatives of Vital Statistics, Genetics programs, the Center for Public Health Laboratories (CPHL), Immunization Alert Registry and Newborn Hearing Screening met to discuss the future goal of integration. In May, staff from CCFH and CPHL began more detailed discussions on the linkage of the two screening databases. Data infrastructure development and data integration projects are high priorities for OHD. CCFH and the OHD maintains several other databases with a potential for linkage, which could result in better tracking and follow-up of infants with hearing loss:

CCFH-RELATED DATABASES

Database: Immunization ALERT Registry
Purpose: Track status of all children in Oregon; improve immunization completion rates. Currently covering 94% of Oregon children age birth through five years, 78% of private providers, 96% of public providers.

Database: Women's and Children's Health Data Systems Integration Project (WCHDS)
Purpose: Collect encounter data from programs administered by CCFH-CDRC through local health departments and track local health department client utilization of services. Will progressively integrate WIC, Immunization-Alert, Babies First!, CaCoon, Perinatal, and Well-Child databases over the next 3 years.

Database: WIC
Purpose: The Oregon WIC program is currently pilot testing a new client intake system, known as The WIC Information System (TWIST).

Database: Oregon Healthy Families Surveillance System
Purpose: Begin building a comprehensive surveillance system to monitor the health status of women, children, children with special needs, and families. Use the system to provide programs with useful information, and integrated data analysis and data warehousing.

Database: Oregon Genetics Planning Project
Purpose: Develop plans for an integrated child and family health information system, with the capacity to generate individual and community-based child health profiles to facilitate linkage of identified children and families with early intervention and health care services. Consider creation of Birth Defects Registry.

Database: Outcome Assessment through Systems of Integrated Surveillance (OASIS)
Purpose: Center for Disease Prevention and Epidemiology-based Data Warehouse designed to store stable, historic disease registry data, vital statistic data, and behavioral survey data in a central location on a common platform, to improve access to its use in critical decision-making and assessment activities.

Six hospitals in Oregon have already been operating screening programs using the HI*TRACK data management system developed by the National Center for Hearing Assessment and Management (NCHAM). This software gives hospitals the ability to download results from hearing screening equipment directly into a tracking system that automatically: 1) prints letters to parents and physicians informing them of screening results; 2) generates reports on outcomes data including the numbers of infants passing the screening, referred for follow up, missed, etc; 3) produces a tickler list of infants who need followup; and 4) feeds individual hospital data into a State HI*TRACK system. Data from the anticipated State HI*TRACK system will then be linked with the databases described above.

Challenges, barriers and problems: Based on the experience of other states, OHD understands that helping hospitals to collect accurate hearing screening data on all infants born will be challenging and that without a statewide EHDI surveillance and tracking system, a large proportion of referred children will not receive timely and appropriate diagnostic testing. An additional number of children are also likely to be lost between diagnostic testing and enrollment in early intervention. Distance, expense and the frequent lack of observable symptoms of hearing loss are factors reducing follow-up.

OHD is hampered by the absence of a mandate for tracking and the lack of funding for establishing a tracking system. The Health Division does have the legal authority to request voluntary reporting of individual patient data as part of a "special study" (Appendix A-3); confidentiality is assured. While OHD anticipates cooperation from a substantial portion of hospitals and audiologists, this will remain a voluntary system until the law is changed.

Finally, OHD recognizes the difficulty of linking three database systems with different characteristics and timing. For example, the blood-spot screening is often delayed until after hearing screening has been attempted. The Electronic Birth Certificate is submitted only once and blood-spot screening twice, while EHDI data may extend from 24 hours of age to a second screen two weeks later, to a diagnostic test in the following months, to an early intervention enrollment at 6-12 months of age. No one form or format will easily encompass all three procedures. Creating common identification and linkage information will be a challenge.

B. Goals and Objectives

The overall aim of this project is to ensure that every newborn will have his/her hearing screened within 30 days, and if referred, undergo diagnostic testing within three months of age and if diagnosed with a hearing loss, receive early intervention services within six months, through a coordinated comprehensive EHDI system. By bringing together public and private partners and applying public health practices, we will jointly improve the overall quality of life for Oregonians affected by a hearing loss. Listed below are three goals, with a rationale and objectives for each goal.

Goal 1: Create a statewide EHDI surveillance and data tracking system.

Rationale: The surveillance and tracking system will allow the Oregon Health Division to monitor statewide, by county, by hospital and by race/ethnicity and other demographic factors: a) the performance of the screening program, including the success of the screening program in identifying all children with a significant hearing loss, b) the success at and timeliness of obtaining diagnostic services and early intervention services when indicated, and c) geographic and demographic barriers to obtaining any of the above services.

• Objective 1.1. Develop standardized data collection and tracking methods.
• Objective 1.2. Define and build the EHDI database within the OASIS data warehouse.
• Objective 1.3. Collect monthly standardized data from all participating hospitals, screening or diagnostic audiology facilities and early intervention programs.
• Objective 1.4. Monitor hospital performance in the screening program.
• Objective 1.5. Publish a manuscript describing the tracking system, definitions, methodology, collaborative relationships, data collection, findings, and recommendations.

Goal 2: Build a coordinated EHDI infrastructure, including a case-finding system to ensure minimal loss to follow-up of infants with hearing loss.

Rationale: A case-finding system will allow OHD to identify families that have not successfully navigated the program and intervene to assure minimal loss to follow-up.

• Objective 2.1. Support the Advisory Committee in seeking a legislative mandate for expansion to universal screening, for mandatory reporting, and the legal authority for case-finding and intervention.
• Objective 2.2. Document parental concerns about the EHDI process.
• Objective 2.3. Document professional concerns about the EHDI process.
• Objective 2.4. Identify barriers to a successful EHDI program.
• Objective 2.5. Investigate and implement case-finding procedures.

Goal 3: Create a unified child health profile, encompassing the various child health databases, to facilitate the delivery of health care to children in general and children with special health care needs in particular.

Rationale: Consolidation or linkage of demographic and medical information, including the Electronic Birth Certificate, Newborn Hearing Screening, Newborn Metabolic Screening, the Women's and Children's Health Data Systems Integration Project (WCHDS), and the Oregon Healthy Families Surveillance System, will help achieve the ultimate aim of getting children into services as early as possible.

• Objective 3.1. Develop linkage between the EHDI database and the newborn metabolic screening database.
• Objective 3.2. Develop a detailed plan for linkages between the EHDI database and other newborn and child health databases.
• Objective 3.3. Implement the data integration plan.

Both sexes and racial and ethnic minority populations will be represented to the extent that they are represented in the cohort of newborns born in hospitals offering screening or seek screening independently. OHD cannot control the race, ethnicity, and/or sex of subjects. OHD will however consider these factors when analyzing the data.

C. Description of Program and Methodology

The target region of this project is the State of Oregon, which has slightly more than 46,000 births per year. The project methodology, including goals, specific measurable objectives to meet those goals, and specific activities to be performed, is described in further detail in the Table 2 following this narrative. The time line is contained in Appendix A-1.

Although the 1999 Oregon legislature did not provide statutory authority for mandatory reporting of data, OHD has the statutory authority to collect individual patient data as part of a "special study"; confidentiality is assured and hospitals and others are authorized to release information to the OHD under this separate statute (see Appendix A-3).

Staff of the Perinatal and Child Health Section of the Center for Child and Family Health (CCFH) will be responsible for the day-to-day operations of the Oregon EHDI Surveillance and Tracking Project. Upon award of the grant, CCFH will notify hospitals, screening and diagnostic audiologic facilities and early intervention agencies of the initiation of a "special study with respect to the causes and prevention" of permanent congenital hearing loss. CCFH will identify those hospitals, audiologic facilities and early intervention agencies willing to participate on a voluntary basis. (See Appendix A-4 for those facilities already committed to participating )

As an added incentive to potential participants, CCFH will make the HI*TRACK software available free of charge for two years in exchange for a written agreement with the Health Division to provide surveillance data. Paper reporting forms will be provided for those facilities participating but declining HI*TRACK. Reporting will be as described in Table 2, section 1.1.a. and 1.3.a. The Program Coordinator will assist facilities in the installation of the software in September 2000. Ongoing technical support will be provided by the NCHAM technical assistance center.

The Office of Information Services of the Department of Human Services will design an Early Hearing Detection and Intervention Database within OASIS Data Warehouse. The Information Specialist will also develop automated processes for updating data and processes for record matching and exclusion, using the Electronic Birth Certificate (EBC) data and HI*TRACK information. This database will be used for epidemiological analysis and sharing with the CDC, following de-identification.

Beginning November 2000, the Health Division will begin collecting monthly data from reporting sites, entering data in the State Module of HI*TRACK and exporting it to the EHDI database within OASIS. The Program Coordinator and Research Analyst will review data monthly, as described in Table 1, to identify unusual clusters. Analysis of the first 12 months' of data will begin November 2001 and a report completed by February 1, 2002.

Should the Newborn Hearing Screening Advisory Committee succeed in its stated goal of modifying the newborn hearing screening legislation during the 2001 legislative session to include system-wide mandatory reporting, OHD will, upon implementation of the legislation, collect reporting data from all mandated facilities. Further, should the Advisory Committee obtain authorization, funding and position authority for case-finding, OHD will integrate case-finding into the EHDI system. Should the Advisory Committee not succeed, OHD will explore other options to reduce loss to follow-up.

For example, if the EHDI database and WCHDS were linked, OHD might be able to notify local public health authorities of clients in need of follow-up. For any system of case-finding/follow-up, issues of informed consent will need to be resolved, either legislatively or by individual release, depending on the nature of the system developed. In any case, OHD will work closely with the Advisory Committee to develop and improve a comprehensive and coordinated EHDI system.

During the first year of the grant, OHD will develop plans to integrate the Electronic Birth Certificate, the EHDI database and the Newborn Metabolic Screening database. CCFH staff have already held meetings with CPHL staff to discuss options for integration. These efforts will continue, with the additional involvement of the Information Specialist assigned to the EHDI project. The goal is full integration within the second year of the grant.

During the second year of the grant, attention will shift to integration with additional databases, including WCHDS, Immunization Alert, WIC/TWIST and a potential Birth Defects/Genetics Registry. The Project Co-Director, Project Coordinator, MCH Epidemiologist and Perinatal and Child Health Manager will sit on the OHD/CDRC Genetics Team, whose primary purpose is to address integration, expansion and improvement of public health information systems, including data issues related to children and families affected by genetic conditions and other special health needs, to develop a vision of an "ideal" integrated child and family health information system and identify potential linkages, additions and current system changes that could be implemented to help a system with the capacity to generate individual and community-based child health profiles, link identified children and families with early intervention and health care services and be useful for health care and social service providers in the provision of coordinated care for individual children and their families.

During the final years of the grant, OHD will seek to improve the performance of the EHDI system, in cooperation with the Advisory Committee, primary care providers and parents, and other stakeholders and to further integrate the EHDI database with other child health and related databases.

In addition to the above, the grant will fund interpreter services for deaf or hard of hearing members of the Advisory Committee during committee meetings.

Activities Timeline Allocation (Oregon EHDI Surveillance and Tracking Project)

Goal 1: Create a statewide EHDI surveillance and data tracking system.

Objectives: 1.1. By November 1, 2000, develop standardized data collection and tracking methods (Grant Level I-Activity b).
Activities:

• 1.1.a.The MCH Epidemiologist and the Program Coordinator will identify desired data fields, including but not limited to: name of child, date of birth, hospital of birth, hospital transfer during neonatal period, name of mother, date of birth of mother, social security number of mother, maternal race/ethnicity, maternal and paternal education level, insurer for labor and delivery, marital status, county of residence, birth weight, date(s) of screening, method(s) of screening, results left and right, date of diagnostic testing, results of diagnostic testing, diagnosis, type of hearing loss, degree of hearing loss, laterality of hearing loss, date of EI evaluation, results of EI evaluation, date of enrollment in EI services, type of intervention provided, and other data fields as determined by consultation with the CDC and other grant recipients. From EI institutions: type, degree and laterality of hearing loss, date of diagnosis and method of identification, to enable analysis of children with progressive or late onset hearing loss.
• 1.1.b. The Program Coordinator will contact the CDC regarding recommended additional data fields.
• 1.1.c. The Program Coordinator will survey all screening hospitals, screening or diagnostic audiologic facilities and all public and private early intervention programs and confirm willingness to participate in a Special Study Regarding Congenital Hearing Loss and determine mode of reporting: via HI*TRACK on diskette or by paper.
• 1.1.d. The Program Coordinator will develop reporting forms that include all desired information for those facilities not choosing to report through software. 1.1.e. The Health Division will declare the initiation of a Special Study Regarding Congenital Hearing Loss and enter into agreements with all participating facilities to receive HI*TRACK, through October 2003, in exchange for data reporting.
• 1.1.f. The Program Coordinator will distribute copies of HI*TRACK and provide phone assistance in its installation and setup. The Program Coordinator will distribute forms to those facilities reporting by paper.
• 1.1.g. Beginning October 1, 2000, the Health Division will begin accepting monthly data from all participating facilities, on a pilot basis, to identify and solve problems in the transmission and entry of the data into the HI*TRACK state module.

Objective: 1.2 Beginning October 1, 2000, define and build the EHDI database within the OASIS, consisting of data derived from HI*TRACK and the Electronic Birth Certificate.
Activities:

• 1.2.a. By January 1, 2001, the Information Specialist will design an EHDI Database that includes all identified fields and resides within OASIS.
• 1.2.b. By January 1, 2001, the Information Specialist will develop automated processes for the ongoing updating of the information in the EHDI database.
• 1.2.c. By January 1, 2001, the Information Specialist will work with the Program Coordinator and Research Analyst to define and implement record matching and exception processes, Metadata documentation and process/procedure documentation.
• 1.2.d. The Information Specialist will work with the Program Coordinator and staff of the CPHL to explore importation of information from CPHL Newborn Metabolic Screening data into the EHDI database.

Objective: 1.3. Beginning November 1, 2000, collect standardized monthly data from participating facilities (I-c and I-d).
Activities:

• 1.3.a. Using either the HI*TRACK data transfer function or the forms provided by the Health Division, the Program Coordinator will collect data on a monthly basis from every hospital providing screening services, screening or diagnostic audiologist and early intervention program that has agreed to participate in the Special Study. Every participating Regional Program or private EI program shall submit the requested data on every child who is deaf or hard of hearing, from birth to school age, upon initial enrollment in the EI system, encompassing both children who received newborn hearing screening and those who did not and allow analysis of late onset or progressive hearing loss.
• 1.3.b. The Program Coordinator or the Research Analyst shall enter all electronic and paper information into the HI*TRACK State Module. The Program Coordinator will contact those facilities who have not provided the required monthly data by the tenth of each month.
• 1.3.c. Beginning January 1, 2001, the Research Analyst shall on a monthly basis export the Hi*Track data to the EHDI database and carry out a linkage and matching protocol with the EBC.

Objective: 1.4. Beginning December 1, 2000, monitor hospital performance in the screening program (I-e).
Activities:

• 1.4.a. On a monthly basis, the Research Analyst and the Program Coordinator will analyze the data (using first HI*TRACK, then the EHDI database when ready), including: percentage of newborns screened, percentage referred for diagnostic testing, percentage who were referred for diagnostic testing that have received diagnostic testing, false positive rates, and loss to follow-up rates for diagnostic services and EI statewide, by hospital and by county when indicated.
• 1.4.b. The Program Coordinator will inform any facility demonstrating an unusual cluster in the above analysis and assist in the corrections of any identified problems.

Objective: 1.5. By February 1, 2002, publish a manuscript(s) describing the tracking system, definitions, methodology, collaborative relationships, data collection, findings and recommendations (I-e, I-i).
Activities:

• 1.5.a. Beginning November 1, 2001, following collection of 12 months' worth of data, the Program Coordinator and Research Analyst shall analyze data from the first year of operation of the surveillance system. This analysis shall include, but not be limited to: percentage of newborns screened overall and by hospital, percentage of newborns referred for diagnostic testing overall and by hospital, percentage of newborns who were referred for diagnostic testing and have received diagnostic testing overall, by hospital and by county, false positive rates overall and by hospital, and loss to follow-up rates for both diagnostic services and EI overall, by hospital and by county; differences in the rates of screening, diagnosis or early intervention by county of origin, socioeconomic status or race/ethnicity; false negative rates of newborn hearing screening; prevalence, degree, type and laterality of permanent congenital hearing loss identified by the screening process; the prevalence of late onset or progressive hearing loss, age of identification and method of identification.
• 1.5.b. By December 1, 2001, the Program Coordinator shall prepare a report detailing findings of the analysis and present this report to the Newborn Hearing Screening Advisory Committee.
• 1.5.c. The Newborn Hearing Screening Advisory Committee shall review the findings and develop recommendations for improving the EHDI program.
• 1.5.d. By February 1, 2002, the Health Division shall publish and disseminate a manuscript(s) incorporating the recommendations of the Advisory Committee.

Goal 2: Build a coordinated EHDI infrastructure, including a case-finding system to ensure minimal loss to follow-up of infants identified with hearing loss.

Objective: 2.1. Support Advisory Committee efforts to seek a Legislative mandate for expansion to universal screening, for mandatory reporting and the legal authority for case-finding and intervention (I-g).
Activities:

• 2.1.a. CCFH will assist the Advisory Committee work to have draft legislation introduced, proposing legislative modifications to the EHDI program in the 2001 legislative session, consisting of expansion of the mandate to cover all newborns, adoption of mandatory individual-level reporting, institution of case-finding and intervention to improve referral follow-through and sufficient resources for program evaluation.
• 2.1.b. During the 2001 legislative session, the Advisory Committee will promote the draft legislation. OHD will provide information to the Legislature, including data obtained from the PRAMS survey regarding frequencies of hearing screening, referral and diagnostic testing, to drive policy.
• 2.1.c. Should the Advisory Committee recommendations not be adopted, the Advisory Committee will seek new legislation in the 2003 Legislative session. The Health Division will utilize data gathered from the surveillance system to drive policy.

Objective: 2.2. Document concerns from parents about the EHDI process. (I-f)
Activities:

• 2.2.a. In April 2001, add questions to the PRAMS survey to identify parental concerns and perceived barriers to follow up. PRAMS is sent to a random sample of 15% of new mothers, with socioeconomic and racial/ethnic over-sampling. Information obtained will be used to drive policy and program changes in Oregon's EHDI.

Objective: 2.3. Document concerns from professionals about the EHDI process. (I-f)
Activities:

• 2.3.a. At each meeting of the Advisory Committee, seek feedback from members of the Advisory Committee representing the Oregon Pediatric Society (OPS), Oregon Medical Association (OMA) and the Oregon Association of Hospitals and Health Systems.
• 2.3.b. At least annually, approach the OPS, OMA, the Oregon Academy of Family Practitioners, Oregon Association of Otolaryngology, Oregon Academy of Audiology, Oregon Speech Language Hearing Association and Oregon Department of Education Office of Special Education for feedback or the opportunity to attend a meeting and seek feedback.

Objective: 2.4. Identify barriers to successful functioning of the EHDI system (I-f)
Activities:

• 2.4.a. By January 1, 2002 and annually thereafter, OHD will determine the risk of not getting a screening or diagnostic test or EI enrollment, by maternal race/ethnicity, maternal/paternal education level, insurer for labor and delivery, marital status, county of residence, birth weight, hospital of birth and neonatal transfer status and report this information to the Advisory Committee and Legislature.

Objective: 2.5. Investigate and implement case-finding procedures.(I-g).
Activities:

• 2.5.a. The Health Division will continue to convene, provides staff and other support to, and rely upon input from a broad-based Advisory Committee.
• 2.5.b. The EHDI staff will meet with staff from the Center for Public Health Laboratories to learn about their experience with case-finding.
• 2.5.c. The Program Coordinator and MCH Epidemiologist will contact other states' EHDI programs to learn about other states' experiences with case-finding.
• 2.5.d. The Program Coordinator and MCH Epidemiologist will contact other states, NCHAM and the CDC regarding experiences building a coordinated program.
• 2.5.e. Should the Advisory Committee recommendations be adopted in whole or in part by the Oregon Legislature, the Health Division would be prepared to facilitate expansion of screening to all newborns as mandated by law; to adopt Administrative rules detailing procedures for mandatory reporting of individual-level data; to resolve issues of informed consent regarding release of/sharing of patient information; and to hire 2.0 FTE of Program Technician 2 for case-finding and intervention to assure follow-through with referrals.
• 2.5.f. The Program Coordinator and MCH Epidemiologist will explore linkages to WCHDS and the possibility of using the WCHDS database to identify children in need of follow-up who are also receiving services from local health departments (LHDs) and then using LHDs for case-finding.

Goal 3. Create a unified child health profile, encompassing the various child health databases, to facilitate the delivery of health care to children in general and children with special health care needs in particular.

Objective: 3.1. By September 1, 2001, develop linkage between the EHDI Database and the Newborn Metabolic Screening Database.
Activities:

• 3.1.a. Beginning September 2000, the Program Coordinator and MCH Epidemiologist will contact other states to investigate their experiences with linking newborn hearing screening, the Electronic Birth Certificate and newborn metabolic screening. (Based on current information, we are leaning toward the creation of a unique identifier issued at birth that would be entered into all three databases facilitating linkage downstream.)
• 3.1.b. EHDI program staff meet with the CPHL staff, Vital Statistics staff and the Office of Information Systems staff regarding the best method of linkage. By January 2001, internal Health Division agreement will be reached on an approach to linkage.
• 3.1.c. EHDI program staff will open discussions with the Oregon Association of Hospitals and Health Systems and the larger health systems in Oregon regarding options for linkage.
• 3.1.d. By September 2001, we will implement linkage of the EBC, newborn hearing screening and newborn metabolic screening data.

Objective: 3.2. By September 1, 2002, develop a detailed plan for linkages between the EHDI database and other newborn and child health databases identifying children with special health care needs.
Activities:

• 3.2.a. The Project Directors, Project Coordinator, MCH Epidemiologist and Perinatal and Child Health Section Manager will sit on an expanded OHD/CDRC Genetics Team, to address integration, expansion and improvement of public health information systems, including the creation of a "child health profile.".
• 3.2.b. With the OHD/CDRC Genetics Team, explore the creation of a Birth Defects Registry that could be integrated with the EHDI and Newborn Metabolic Screening databases.
• 3.2.c. The Project Coordinator and MCH Epidemiologist will engage in bilateral discussions with the WCHDS staff regarding integration with this public health database.
• 3.2.d. The Project Coordinator and MCH Epidemiologist will investigate other states' experiences in data integration as well as conferring with the CDC and NCHAM.

Objective: 3.3 Beginning in Year 3 of the grant, begin implementing the data integration plan.
Activities:

• 3.3.a. Convene a data integration committee.
• 3.3.b. Develop an implementation time line.
• 3.3.c. Begin implementation.

D. Evaluation Plan

The evaluation will focus on whether or not the activities described for our specific objectives are completed in a timely manner. However, the ultimate success of the project will be measured by the number of infants with hearing loss who are identified and receive early intervention services by age 6 months. The evaluation of our efforts will therefore include not only a description of whether or not our specific objectives have been met, but also the output of the surveillance system itself.

Objective 1.1: Develop standardized data collection and tracking methods

• Data fields identified
• Data reporting forms developed
• HI*TRACK distributed and installed in all participating facilities
• Piloted data collection process

Objective 1.2: Define and build the EHDI database within the OASIS Data Warehouse

• EHDI database developed
• Process for updating database, record matching, and Metadata documentation developed

Objective 1.3: Collect standardized monthly data

• Data collected from hospitals, diagnostic facilities, and early intervention programs
• Hi*Track data exported to EHDI database and matched with the Electronic Birth Certificate

Objective 1.4: Monitor hospital performance in the screening program

• Results of the monthly analysis of data by hospital

Objective 1.5: Publish a manuscript describing the tracking system

• Report detailing findings of the analysis
• Published manuscript

Objective 2.1: Assist the Advisory Committee in seeking a legislative mandate

• Provide technical assistance in the drafting of legislation.
• Results of PRAMS survey communicated to Legislature.

Objective 2.2: Document parental concerns

• Results of PRAMS survey communicated to Advisory Committee and EHDI program

Objective 2.3: Document professionals' concerns

• Feedback from Advisory Committee members and other stakeholders documented

Objective 2.4: Identify barriers to successful functioning of the EHDI system

• Report to Advisory Committee regarding demographic risks of missed screening or loss to follow-up enrollment documented.

Objective 2.5: Investigate and implement case-finding procedures.

• At least quarterly meetings of the Advisory Committee scheduled
• New Oregon Administrative Rules adopted
• Case finding staff hired and plan for case finding developed

Objective 3.1: Develop linkage between the EHDI and Newborn Metabolic Screening databases

• Plan describing approach to linkage
• Linked data

Objective 3.2: Develop a plan for linkages with other newborn and child health databases

• Plan developed

Objective 3.3: Begin implementing data integration plan

• Data integration committee convened
• Time line developed
• Integrated data

Additional Indicators to be evaluated include:

• By September 1, 2001:
  • 60% of all newborns will receive a hearing screening test;
  • the refer rate from screening to diagnostic testing will be no greater than 7.5%;
  • 40% of referred newborns will receive diagnostic testing;
  • 50% of newborns undergoing diagnostic testing will do so by 3 months of age;
  • 60% of infants with a diagnosed hearing loss will enter EI by 6 months of age.
  • 80% of infants with a diagnosed hearing loss will enter EI by 12 months of age.

There will be a detailed plan for the integration of the newborn metabolic screening data with the hearing screening data and Electronic Birth Certificate.

• By September 1, 2002:
  • 80% of all newborns will receive a hearing screening test;
  • the refer rate from screening to diagnostic testing will be no greater than 5%;
  • 65% of referred newborns will receive diagnostic testing;
  • 80% of newborns undergoing diagnostic testing will do so by 3 months of age;
  • 80% of infants with a diagnosed hearing loss will enter EI by 6 months of age.
  • 90% of infants with a diagnosed hearing loss will enter EI by 12 months of age.
  • there will be a detailed plan for the further integration with other public health databases.

E. Collaborative Efforts

The EHDI Surveillance and Data Tracking project will build on OHD's reputation in convening key partners and encourage collaborative efforts in developing this system to identify and treat early hearing loss. Both the Child Development and Rehabilitation Center (CDRC), home of Oregon's Children With Special Health Needs program, and the Department of Education Office of Special Education are well represented on the Newborn Hearing Screening Advisory Committee. The OHD has worked - and will continue to work - closely with this committee in the design and implementation of Oregon's newborn hearing screening program.

Collaboration with hospitals, diagnostic centers and intervention services: Kaiser Permanente, Legacy Health Systems, Oregon Health Sciences University, Providence Health Systems, Rogue Valley Medical Center, St. Charles Medical Center (collectively responsible for 48% of Oregon births) and the Oregon Association of Hospitals and Health Systems have been represented on the Advisory Committee. Administrative rules were drafted by and unanimously supported by the Advisory Committee.

Five hospital-based audiologists sit on the Advisory Committee and with two audiologists representing early intervention Regional Programs and the OHD Project Coordinator comprised the Audiology Working Group of the Advisory Committee. The Working Group developed the criteria for screening, and protocols for training screeners and for diagnostic testing. They assisted the OHD in surveying licensed Oregon audiologists and developing criteria for placement on the official list of diagnostic facilities. The five audiologists on the Advisory Committee represent four of twelve diagnostic centers. A representative from the Oregon Speech Language Hearing Association also sits on the Advisory Committee.

There are five representatives of both public and private early intervention agencies who sit on the Advisory Committee, including the chair of the Advisory Committee.

Eight hospitals, representing over 60% of Oregon births (and including affiliated diagnostic centers), several independent diagnostic centers, the three private EI programs, the largest regional EI program, and the Department of Education Office of Special Education have to date submitted written assurances of a willingness to participate in the surveillance system (see Appendix A-4).

Collaboration with other screening programs: EHDI staff have already met twice with staff of the CPHL, Oregon's other newborn screening program. There is agreement to explore linkages between the two screening programs and the Electronic Birth Certificate.

F. Staffing and Management System

The Oregon EHDI Surveillance and Tracking Project will be under the overall leadership of the CCFH Director, Donalda Dodson and Dr. Jerry Sells, director of the Child Development and Rehabilitation Center (CDRC) of the Oregon Health Sciences University (Oregon's Children with Special Health Needs program). The Project Coordinator, Dr. Martin Lahr will direct the activities of the grant. The staffing plan represents the disciplines of pediatrics, epidemiology, nursing, public health, research methodology, as well as management (see Appendix A-5).

Donalda Dodson, RN, MPH, Assistant Administrator and CCFH Director/Title V Director (in-kind position), will serve as the project co-director for the grant. In addition to over 20 years of management experience, Ms. Dodson brings valuable experience directing the development of the Women's and Children Health Data System and is a leader of the OHD's Information System Services Committee.

Clifford J. Sells, MD, MPH, CDRC Director (in-kind), will serve as the project co-director and was Chair of the 1998 Advisory Committee. A developmental pediatrician, Dr. Sells has directed programs for children with special needs for over 20 years.

Martin Lahr, MD, FAAP, Child Health Consultant (50% funding), will serve as the project coordinator to facilitate, coordinate, and provide leadership in the achievement of the goals and objectives of this grant. Dr. Lahr has coordinated the adoption of administrative rules and diagnostic protocol, identified and established contact with all hospitals providing screening, identified and disseminated lists of screening or diagnostic audiologic facilities and lists of early intervention programs. He has staffed all subcommittees of the Advisory Committee. Currently, the Program Coordinator position is unfunded and Dr. Lahr's salary will be subsidized by DHS's Mental Health and Developmental Disabilities Services Division only through June 2001.

Jill Skrezyna, MPH, Perinatal and Child Health Section Manager (in-kind), participated on the 1998 advisory committee and helped develop the recommendations to implement newborn hearing screening in Oregon. Ms. Skrezyna manages the program responsible for implementing the newborn hearing screening law and will provide oversight for the grant.

Ken Rosenberg, MD, MPH, Maternal and Child Health Epidemiologist (in-kind), participated on the 1998 advisory committee, helped develop the recommendations to implement newborn hearing screening in Oregon, and has expertise in epidemiologic methods, public health surveillance, research and integration. Dr. Rosenberg, who developed and also runs Oregon's PRAMS survey, will serve as the project consultant.

Sherry Spence, MCH Data Systems Coordinator (in-kind), is currently coordinating the MCH state and local data systems integration planning and will be closely involved in planning and implementation of data integration efforts. Ms. Spense co-developed Montana's Integrated Data for Evaluation and Assessment Project to integrate public health data at local and then state levels, led the project evaluation team and consulted on systems design. In addition she directed Montana's Health Statistics Program and co-developed Montana's County Health Profiles, making county demographic, health status and health resource data available to public health professionals statewide.

In addition, the Public Health Lab director and staff will be directly involved in efforts to integrate the EHDI and newborn blood-spot screening databases.

Proposed positions include: 0.50 FTE Research Analyst 3, who will provide technical support in the areas of data collection, data management, data analysis and report preparation. An Information Specialist 6 will provide technical support in the design of the EHDI Database, automated updating processes, record matching and exception processes, Metadata documentation and process/procedure documentation as well as database linking; FTE will begin at 0.5 for the first four months, decline to 0.25 FTE for the rest of the first year and to 0.1 FTE thereafter..

G. Organizational Structure

The Oregon Health Division, which is part of the Oregon Department of Human Services, is the state agency charged with protecting, promoting, and preserving the health of Oregon's 3.2 million people. The EHDI project will be established in the OHD's Center for Child and Family Health (CCFH), which is the state's Title V agency. CCFH's Perinatal and Child Health Section will be responsible for the day-to-day operations of the project. At the present time, CCFH manages all newborn hearing screening activities and several surveillance and data projects. This project will work closely with the Oregon Children With Special Health Needs program at the Child Development and Rehabilitation Center of the Oregon Health Sciences University. (See Appendix A-5)

Space available to the project includes an existing office for the coordinator and supporting staff. OHD maintains several general purpose meeting rooms in which the Advisory Committee and its subcommittees meet. An adequate number of computers in CCFH are available to carry out the activities of the grant.

H. Human Subjects Review

OHD's Institutional Review Board does not require formal approval for surveillance projects.