CDC-RFA-DD17-1701PUBLICATION.pdf

Centers for Disease Control

National Center on Birth Defects and Developmental Disabilities

Documentation and Use of Follow-up Diagnostic and Intervention Services Data through the Maintenance and Enhancement of the Early Hearing Detection and Intervention Information System (EHDI-IS)

CDC-RFA-DD17-1701

Application Due Date: 03/06/2017

Documentation and Use of Follow-up Diagnostic and Intervention Services Data through the Maintenance and Enhancement of the Early Hearing Detection and Intervention Information System (EHDI-IS)

CDC-RFA-DD17-1701

TABLE OF CONTENTS

Part I. Overview Information Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Application and Submission Information D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-DD17-1701. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry

(ATSDR)

B. Funding Opportunity Title:

Documentation and Use of Follow-up Diagnostic and Intervention Services Data through the Maintenance and Enhancement of the Early Hearing Detection and Intervention Information System (EHDI-IS) C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg /CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at http://www.cdc.gov/od/science/integrity /docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-DD17-1701

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.314 F. Dates:

1. Due Date for Letter of Intent (LOI): 01/30/2017

2. Due Date for Applications: 03/06/2017, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

Funding Opportunity Announcement (FOA) information will be available for potential applicants on two separate conference calls, conducted by the Centers for Disease Control and Prevention Early Hearing Detection and Intervention (CDC EHDI) Team as follows:

The first call is scheduled for Thursday, January 19, 2017 from 1-2pm, EST. The second call is scheduled for Thursday, January 19, 2017 from 7-8pm, EST.

1. Click on the following link to join the visual portion of the conference:

Participant Link.

2. Audio Information

Use the information below to connect:

Toll-free: +1 (877) 874-5447

Participant code: 136111 #

First Time Users

To save time before the meeting, check your system to make sure it is ready to use Microsoft Office Live https://foa.grantsolutions.gov/www.grants.gov https://foa.grantsolutions.gov/www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov https://www.livemeeting.com/cc/cdc/join?id=NK8B2G&role=attend http://go.microsoft.com/fwlink/?LinkId=90703

To save time before the meeting, check your system to make sure it is ready to use Microsoft Office Live Meeting.Pre-Application Conference Calls:

Captioning service is available. If you would like the captioning service, please contact Steve Richardson at SRichardson4@cdc.gov promptly to allow time for testing system compatibility. This service is provided at no charge.

The purpose of the conference calls is to 1) help potential applicants understand the scope and intent of the FOA for the Documentation and Use of Follow-up Diagnostic and Intervention Services Data through the Maintenance and Enhancement of the Early Hearing Detection and Intervention Information System (EHDI-IS) and 2) become familiar with the Public Health Services funding policies and application and review procedures. Since this is a competitive selection process, applicants should follow the requirements as laid out in the FOA and any related amendments. If potential applicants have questions or need clarification prior to this call please see II.Full Text, Section G. Agency Contacts for contact information.

G. Executive Summary:

1. Summary Paragraph:

The Centers for Disease Control and Prevention announces availability of funds for funding opportunity announcement (FOA), Documentation and Use of Follow-up Diagnostic and Intervention Services Data through the Maintenance and Enhancement of the Early Hearing Detection and Intervention Information System (EHDI-IS). The award's purpose is to support jurisdictions that have screened 90% or more of infants in calendar year 2015, have routinely identified deaf and hard of hearing (D/HH) infants, and have demonstrated challenges in providing and documenting follow-up testing and intervention. The FOA involves using five types of strategies: surveillance to implement a complete EHDI-IS; training and support to provide training and technical assistance to address the needs of state partners involved in the EHDI reporting processes; partnership to promote and support coordination and collaboration around capturing data; communication and dissemination to support targeted dissemination of data and information among stakeholders; and monitoring, analysis and evaluation to maintain data quality and guide programmatic improvement. Expected project period outcomes are: Improve the documentation of timely follow-up diagnostic testing and early intervention services, in order to support the early identification of D/HH infants and help address potential developmental delays.

a. Eligible Applicants: Open Competition

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 42 (42 Core Activities and up to 6 Optional Expanded Activities)

d. Total Project Period Funding: $20,700,000

e. Average One Year Award Amount: $150,000

f. Total Project Period Length: 3

g. Estimated Award Date: 06/01/2017

h. Cost Sharing and / or Matching Requirements:

N

Cost sharing or matching funds are not required for this program. Although no statutory matching mailto:SRichardson4@cdc.gov

Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Congenital hearing loss affects one to three of every 1,000 live-born infants and has been referred to as a neuro-developmental emergency. When left undetected hearing loss can negatively impact children through delays in speech, language, social, and emotional development. Jurisdictions have established Early Hearing Detection and Intervention (EHDI) programs to ensure all D/HH infants are identified early and receive intervention services. National benchmarks call for hearing screening no later than 1 month of age, diagnostic audiologic testing no later than 3 months of age (for infants not passing the screening), and enrollment in intervention no later than 6 months of age for those identified as D/HH, and form what is known as the EHDI 1-3-6 plan. For more information on the EHDI 1-3-6 plan, go to https://www.cdc.gov/ncbddd/hearingloss /screening.html or http://www.asha.org/Articles/Early-Hearing-Detection-and-Intervention/.

The Health Resources and Services Administration (HRSA) has awarded grants to support implementation and growth of jurisdictional EHDI programs. The CDC complements their efforts by providing cooperative agreements to develop EHDI Information Systems (EHDI-IS), which serve as a powerful tool to help programs to ensure that all infants receive a hearing screening and recommend follow-up diagnostic and intervention services. Previously, jurisdictions were able to pursue a broad range of activities related to developing an EHDI-IS. These activities often focused on the ability to document the provision of initial hearing screening services, which usually occur before a newborn is discharged from a birthing facility and is the first step in the EHDI process. While screening results are consistently reported to EHDI programs, the same cannot be said for the diagnostic test results, intervention enrollment and outcome data. Jurisdictions continue to face challenges in documenting the receipt of follow-up services. Without the recommended follow-up services D/HH infants cannot be identified early and are at risk for developmental delays.

Furthermore, the benefits of newborn hearing screening are severely diminished when recommended and timely follow-up services are not provided to infants in need. To address these challenges, this FOA focuses on supporting jurisdictions in improving their capacity to document the provision of timely follow-up diagnostic testing and early intervention services, in order to support the early identification of D/HH infants and help address potential developmental delays.

Given the varying capacities of EHDI-IS across programs and to further support progress, this FOA will include required Core and Optional Expanded activities.

The Core activities will support jurisdictions to improve the capacity of their current EHDI-IS to collect complete, accurate, and valid data on follow-up hearing screening, diagnostic testing and early intervention, in accordance with Goals 2-8 of the CDC EHDI-IS Functional Standards. Awardees will work towards meeting all of the “SHALL” requirements of Goals 2-8 listed in: www.cdc.gov/ncbddd/hearingloss /ehdi-is-functional-standards-.html, and are eligible to receive funding up to a maximum $150,000 per year.

The Optional Expanded activities will further strengthen and expand the capacity of jurisdictional EHDI programs and their existing EHDI-IS to capture, report, analyze, and use individual level EHDI data.

Jurisdictions that apply and are selected for the expanded activities are 1) responsible for completing the Core activities and 2) eligible to receive additional funding beyond the Core level of up to $100,000 per year.

https://www.cdc.gov/ncbddd/hearingloss/screening.html https://www.cdc.gov/ncbddd/hearingloss/screening.html http://www.asha.org/Articles/Early-Hearing-Detection-and-Intervention/ http://www.cdc.gov/ncbddd/hearingloss/ehdi-is-functional-standards-.html

b. Statutory Authorities This program is authorized under section 399M (b) (1) of the Public Health Service Act. [42 USC 280g-1 (b)(1)].

c. Healthy People 2020 This program addresses the "Healthy People 2020" focus area(s) of Hearing and other Sensory or Communication Disorders (ENT-VSL 1):

Increase the proportion of newborns who are screened for hearing loss by no later than age 1 month, have audiologic evaluation by age 3 months, and are enrolled in appropriate intervention services no later than age 6 months.

d. Other National Public Health Priorities and Strategies This FOA aligns with CDC strategic directions to strengthen the tracking and surveillance capacity of state public health programs, as well as collaboration and data exchange between public health departments and health care services. It also aligns with the CDC public health priorities of early identification and ensuring the receipt of recommended services. In addition, this FOA aligns with the Joint Committee on Infant Hearing Position Statement, which recommends that states implement data management and tracking systems as part of an integrated child health information system. These systems are to monitor the quality of services and provide a link between health and education professionals and help determine the outcomes of children with hearing loss. The 2007 Joint Committee on Infant Hearing Position Statement is available at http://pediatrics .aappublications.org/content/120/4/898.full?ijkey=oj9BAleg21OIA&;keytype=ref&;siteid=aapjournals and link to the EI Supplement is http://pediatrics.aappublications.org/content/131/4/e1324.full?ijkey=3R4Jv9oSZO j8.&;keytype=ref&;siteid=aapjournals .

The 2013 Position Statement that supplements the 2007 statement is available at: http://pediatrics.aappublica tions.org/content/131/4/e1324

e. Relevant Work CDC EHDI has awarded previous cooperative agreements that have supported jurisdictions in implementing a broad range of EHDI activities. These activities have included developing an EHDI-IS and supporting integration with other child health data systems. These efforts have, helped ensure that over 95% of newborns are screened, and have contributed to identifying over 45,000 D/HH infants early since 2005.

As part of the technical assistance CDC provides to states, relevant work has been made to support the implementation of this FOA:

EHDI-IS Functional Standards were developed to support jurisdictions to identify operational, programmatic and technical criteria that all jurisdictions EHDI program should implement during the processes of developing, using and evaluating the EHDI-IS. This document summarizes recommendations made by the 2015 National EHDI-IS Functional Standard Working Group (FSWG), on the functional requirements for a complete jurisdictional EHDI-IS. The FSWG consisted of members of the CDC EHDI team and program managers/data system experts from nine jurisdictions. Intended users of these standards include state and territorial EHDI program managers, EHDI-IS developers/vendors, and system evaluators ( www.cdc.gov/ncbddd/hearingloss/ehdi-is-funct ional-standards-.html).

1.

As part of the application jurisdictions are required to provide information about the functional standards that the current EHDI-IS does and does not currently meet. This information can be provided using the EHDI System Self Evaluation Tool (ESSET), which is available at: http ://www.cdc.gov/ncbddd/hearingloss/partners.html The activities in the work plan should address meeting the Goals 2-8 of the functional standards that are not yet met by the current EHDI-IS as http://pediatrics.aappublications.org/content/120/4/898.full?ijkey=oj9BAleg21OIA&keytype=ref&siteid=aapjournals http://pediatrics.aappublications.org/content/120/4/898.full?ijkey=oj9BAleg21OIA&keytype=ref&siteid=aapjournals http://pediatrics.aappublications.org/content/131/4/e1324.full?ijkey=3R4Jv9oSZOj8.&keytype=ref&siteid=aapjournals http://pediatrics.aappublications.org/content/131/4/e1324.full?ijkey=3R4Jv9oSZOj8.&keytype=ref&siteid=aapjournals http://pediatrics.aappublications.org/content/131/4/e1324 http://pediatrics.aappublications.org/content/131/4/e1324 http://www.cdc.gov/ncbddd/hearingloss/ehdi-is-functional-standards-.html http://www.cdc.gov/ncbddd/hearingloss/ehdi-is-functional-standards-.html http://www.cdc.gov/ncbddd/hearingloss/partners.html indicated in the ESSET The CDC EHDI Team has developed a new Guidance Manual named: "How to Make Your EHDI Data System a Useful Tool: A practical guide to moving beyond the basics" to provide jurisdictions with relevant information to support their EHDI programs and EHDI-IS. The manual is available at: http ://www.cdc.gov/ncbddd/hearingloss/partners.html

2.

2. CDC Project Description

a. Approach

Bold indicates project period outcome.

The logic model shown for “Documentation and Use of Follow-up Diagnostic and Intervention Services Data through the Maintenance and Enhancement of the Early Hearing Detection and Intervention Information System (EHDI-IS)” describes the relationships between the project activities addressed in this FOA and the intended outcomes. The bolded text in the logic model indicates outcomes that the awardees are accountable for during the project period. The activities and strategies outlined in this FOA are organized into five areas: 1) Surveillance; 2) Training and Support; 3) Partnerships; 4) Strategic Communication and Dissemination; and 5) Monitoring, Analysis and Evaluation.

i. Purpose

The purpose of this funding is to support jurisdictions that have routinely identified D/HH infants, and have demonstrated challenges in providing and documenting follow-up testing and early intervention services (see glossary). This will be achieved by assisting jurisdictions in the identification and implementation of approaches to strengthen their capacity to capture and use complete and accurate follow-up diagnostic and early intervention related data on all infants not passing the initial hearing screening.

ii. Outcomes The following key outcomes are expected to be achieved by the end of the project period, for both core and expanded activities.

Short –Term Outcomes

Increased knowledge and skills among facilities and providers related to reporting diagnostic and early intervention data to the jurisdictional EHDI program Increased collaboration between internal and external partners about sustained tracking and surveillance activities Increased number of providers able to report follow-up re-screening and diagnostic data

Intermediate Outcomes

Increased reporting by providers of all diagnoses (i.e., hearing loss and no hearing loss) to the EHDI program in a timely manner Improved consistency and completeness of early intervention data reported to the EHDI program Increased knowledge among program staff and stakeholders of current strengths and weaknesses of the

EHDI-IS

Improved program planning, policy development, and decision-making to support tracking and surveillance activities

Long-Term Outcomes

Improved documentation of follow-up diagnostic testing to support early identification for infants who did not pass the newborn hearing screening Improved documentation of intervention enrollment status, to help address potential developmental delays.

As noted in the Logic Model, long-term outcomes were created in accordance to CDC EHDI-IS Functional Standards ( http://www.cdc.gov/ncbddd/hearingloss/ehdi-is-functional-standards-.html ). The EHDI-IS Functional Standards contains information and recommendations for configuring an EHDI-IS and are intended to identify operational, programmatic and technical criteria that all jurisdictions EHDI program should incorporate. In order to evaluate EHDI-IS on its performance, the following system attributes from the Updated Guidelines for Evaluating Public Health Surveillance Systems ( http://www.cdc.gov/mmwr/preview /mmwrhtml/rr5013a1.htm) have been adapted for use: data quality, acceptability, usefulness and simplicity.

iii. Strategies and Activities This FOA will include the required Core and Optional Expanded activities:

All applicants are required to apply for Core activities to be considered for funding.

The Core activities will support jurisdictions in improving the capacity of their current EHDI-IS to collect complete, accurate, and valid follow-up screening, diagnostic and intervention data, in accordance with Goals 2-8 of the CDC EHDI-IS Functional Standards: www.cdc.gov/ncbddd/hearingloss/ehdi-is-functional-stand ards-.html.

http://www.cdc.gov/ncbddd/hearingloss/ehdi-is-functional-standards-.html http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5013a1.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5013a1.htm

Surveillance Activities: These include ongoing activities essential to implement a jurisdictional EHDI-IS. While many of these activities represent traditional project functions, awardees should focus on infrastructure resources to enhance the capacity of the existing EHDI-IS to improve the collection, management and efficient use of diagnostic and intervention data, in accordance with Goal 2-8 of the CDC EHDI-IS Functional Standards: www.cdc.gov/ncbddd/hearingloss/ehdi-is-functional-standards -.html. Awardees will work towards meeting all “SHALL” requirements under these goals. In addition, under this group of activities, all awardees will need to maintain both the collection and management of the hearing screening data, and the electronic exchange of demographic data between EHDI-IS and Vital Records. Awardees need to propose a plan for sustaining the project after the period of federal funding ends. Awardees are expected to sustain key elements of the project, (for example surveillance strategies), which have been effective in improving documentation of follow-up diagnostic testing for infants who did not pass the newborn hearing screening.The individuals identified in the Leadership and Surveillance capacity (described under the organizational capacity of this FOA) will attend and participate in an extended in-person Kick-off and planning meeting in Atlanta, GA.

1.

Training and Support: These activities will provide support, technical assistance, and training to data reporters, as well as address the needs of jurisdictional partners involved in EHDI activities. Training should be targeted toward new diagnostic facilities with substantial change in personnel and providers (i.e., audiologist, ears, nose, and throat specialist (ENTs)) reporting data.

2.

Partnerships: Key partners and stakeholders are crucial components for successful implementation of the EHDI-IS. Potential organizations for collaboration include: other state and territories, early intervention programs, birthing hospitals, home birth facilities, audiologists, diagnostic facilities, pediatric clinicians, health care systems and healthcare provider groups, and other organizations to aid in minimizing loss to follow-up and loss to documentation; reducing delays in receiving diagnostic evaluation for infants not passing the hearing screening; and increasing enrollment in early intervention (EI) for infants confirmed to have a hearing loss. All collaborations proposed, must include sufficient details in the letters of support, and, if available MOUs/MOAs describing what will be done as part of the collaboration must be included in the application package.

3.

Strategic Communication & Dissemination: Strategic communication and dissemination of information is crucial to support and increase the usefulness of the EHDI-IS. Findings from data analyses and evaluation conducted by the applicant should be regularly disseminated to key stakeholders and partners. Findings and lessons may be shared through various communication modes, such as reports, presentations, webinars and websites. In addition, applicants are expected to improve EHDI-IS visibility (e.g., publish and disseminate fact sheets, reports, briefs, newsletters, or other materials as needed to support project activities). Applicants should consider presenting at state, regional and national meetings and conferences, such as those held by the American Academy of Audiology, American Speech-Language-Hearing Association, and the National EHDI Meeting.

4.

Monitoring, Analysis and Evaluation: This group of activities will lead to strategic actions for program improvement (e.g., processes to reduce errors, eliminate duplicate records, and ensure accuracy and validity of the data reported). Data analysis plan (trend analysis, analysis to identify demographic groups that should be targeted to reduce LFU/LTD, or similar analysis) will be implemented. The attributes of the EHDI-IS to be evaluated for both the Core and the Expanded activities include:

5.

Data quality (accuracy, completeness, uniqueness and timelines) of the diagnostic and early intervention data.

Acceptability of the EHDI-IS among the data reporters (audiologist and/or diagnostic centers).

Usefulness and simplicity attributes of the EHDI-IS among the program and stakeholders.

The Optional Expanded activities will complement the Core activities and will focus on assisting qualified jurisdictions to expand the capacity of their EHDI-IS to analyze, report and use individual level EHDI data.

Collaborate with CDC to develop and implement a protocol for the pseudonymization of individual level EHDI data that will be transmitted to CDC.

The individuals identified in the Leadership, Surveillance, and Data Analysis capacity (described in the organizational capacity of this FOA) will attend and participate in an extended in-person Kick-off and planning meeting in Atlanta, GA.

Construct, validate, and submit limited* data sets of information from the EHDI-IS using data specifications and format specified by CDC.

Collaborate with CDC to conduct detailed analysis on the transmitted limited data set to identify data errors and factors related to the successful receipt of timely services, and loss to follow-up (LFU).

Identify methods to improve data quality and the reporting process.

*Technical Notes:

Information in a limited data set is not directly identifiable and excludes 18 elements that could be used to identify the individual or of relatives, employers, or household members of the individual as specified in 45 CFR §;164.514 (e)(2).

According to 45 CFR §164.514 (e)(2), a limited data set is protected health information that excludes the following direct identifiers of the individual or of relatives, employers or household members:

names, postal address, telephone numbers, fax numbers, electronic mail addresses, social security numbers, medical record numbers, health plan beneficiary numbers, account numbers, certificate/license numbers, vehicle identifiers and serial numbers, device identifiers and serial numbers, web universal resource locators, internet protocol address numbers, biometric identifiers including fingerprints and voice, and full face photographic images and any comparable images.

De-identification methods should be used to ensure that the data had successfully undergone pseudonymization before a data file is transmitted.

For more information on the de-identification methods, refer to Chapter 5 of the EHDI Guidance Manual at http://www.cdc.gov/ncbddd/hearingloss/partners.html .

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

The CDC will assist jurisdictions with improving the collection, management, and use of diagnostic and intervention data. The earlier children with hearing loss are identified and receive intervention services, the more likely they will reach their full potential. Collaboration is therefore strongly encouraged for the reasons described above. Awardees are required to collaborate with CDC to achieve the outcomes of this FOA. Selected applicants are required to attend and participate in an in-person kick-off and planning meeting in Atlanta, as well as attend the annual National EHDI conference for the purpose of sharing the latest information and collaborating with other experts in the field of early hearing loss on best practices in early hearing detection and surveillance.

b. With organizations not funded by CDC:

Applicants should collaborate with other programs as needed, to collect and use complete and accurate data.

Collaborations with strategic partners who are essential to the effective implementation of their selected strategies will facilitate strengthening information exchange between health information systems. Potential organizations for collaboration include: Early Intervention (EI) programs, audiologists, clinicians, health care systems and healthcare provider groups, and other organizations to aid in minimizing loss to follow-up and loss to documentation; reducing delays in receiving diagnostic evaluation for infants not passing the hearing screening; and increasing enrollment in EI services for infants confirmed to have a hearing loss.

All collaborations proposed, must include sufficient details in the letters of support, and if available, MOUs/MOAs describing what will be done as part of the collaboration must be included in the application package.

https://www.gpo.gov/fdsys/pkg/CFR-2002-title45-vol1/pdf/CFR-2002-title45-vol1-sec164-514.pdf

2. Target Populations The target populations for the proposed project are as follows:

Infants not passing the initial hearing screening and referred for diagnostic testing Infants identified as D/HH and referred for intervention

Applicants must address the Target Populations and Health Disparities requirements as described in the CDC Project Description. Applicants will describe the specific target population(s) in their jurisdiction, and explain how they will achieve the goals of the award and/or alleviate health disparities.

a. Health Disparities Applicants should strive to improve the documentation of timely follow-up diagnostic testing and early intervention services in order to support the early identification of Deaf and Hard of Hearing (D/HH) infants for the entire population, and seek to reduce gaps in those services by targeting underserved populations.

Disparities by race, ethnicity, socioeconomic status, access, primary language, health literacy, education, and other relevant dimensions (e.g., rurality, tribal communities) should be considered. Applicants should address how specific populations will be included as described in the Approach section.

iv. Funding Strategy

NA

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Evaluation and performance measurements help demonstrate achievement of project outcomes; build a stronger practice base for specific project strategies; clarify applicability of the evidence-based interventions to different populations, settings, and contexts; and support continuous program improvement. Evaluation and performance measurements also can determine if program activities are scalable and effective at reaching target populations. The EHDI-IS evaluation strategies can be supported by the “Updated Guidelines for Evaluating Public health Surveillance Systems” July 27, 2001/50(RR13); 1-35 available at: www.cdc.gov /mmwr/preview/mmwrhtml/rr5013a1.htm and the document: Planning an Evaluation of an EHDI Information System available at: www.cdc.gov/ncbddd/hearingloss/documents/planning-an-evaluation.pdf

The Performance Measures section, presents how CDC and awardees will monitor the degree to which the strategies were effectively implemented and the degree to which short-term, mid-term and long-term outcomes for the logic model have been achieved. All awardees must develop a draft evaluation plan and performance measurement plan as part of this application. If selected for funding, CDC EHDI will work with the awardees within six months of award to finalize project-specific measurements. The targets are to be achieved by awardees on or before the completion of this award. The following process and outcome measures should be collected and reported at the aggregate level to CDC at the end of each budget period. Awardees are expected to submit this aggregate data, which provide information that demonstrates achievement of project goals and intended outcomes, as well as indicates progress in the ability to document and provide EHDI services.The format will be specified in post-award guidance.

SURVEILLANCE STRATEGIES PROCESS MEASURES

Maintain the collection and management of the hearing screening data

Percentage screening overall

Expected Baseline: 90%

Percentage screening before one (1) month of age http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5013a1.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5013a1.htm http://www.cdc.gov/ncbddd/hearingloss/documents/planning-an-evaluation.pdf

Expected Baseline: 90%

Number of newborns documented by the EHDI-IS (as compared to the total occurrent Births in the Vital Records)

Maintain electronic exchange of demographic data between EHDI-IS and Vital Records

Percentage of the records that contains all maternal demographics information

Expand the EHDI-IS capacity to capture diagnostic and early intervention data in a timely manner

Percentage of functional standards achieved by the end of the funding cycle

TRAINING AND

SUPPORT STRATEGIES

PROCESS MEASURES

Provide training and/or technical assistance to address the needs of state partners involved in EHDI process

Documented list of training sessions completed among audiologist and diagnostic facilities and/or capacity sessions with Early Intervention facilities

PARTNERSHIPS STRATEGIES PROCESS MEASURES

Promote and support coordination and collaboration around sustained tracking and surveillance activities within the jurisdiction

Number of and description of meetings to promote EHDI-IS and educate high-level decision makers about the importance of early hearing detection and intervention reporting, and supporting EHDI related activities.

Additional description: Meeting day;

desired outcome of collaboration;

meeting outcome/next-steps

STRATEGIC COMMUNICATION

& DISSEMINATION STRATEGIES

PROCESS MEASURES

Data disseminated to CDC Submit Hearing Screening and Follow-up Survey (HSFS) without error messages to CDC (annually)

Percent completion of Part I, Part II, and Part III HSFS submitted to CDC (annually)

Key information disseminated to internal and external stakeholders

Number and type of communication activities (e.g. reports sent to data reporters); Presentations;Publications, others

MONITORING, ANALYSIS AND

EVALUATION STRATEGIES

PROCESS MEASURES

Monitor Data Description of the processes to identify and correct data issues (e.g.

deduplications, data matching, and data validation)

Analyze data Description of data analysis performed and action taken during the reporting period to maintain quality of the data collected.

Evaluate EHDI Information System Number of evaluation meetings to discuss evaluation planning and dissemination of findings

Number of evaluation plans in place

Number of evaluation reports in place

SHORT-TERM OUTCOMES OUTCOME MEASURES

Increased knowledge and skills among facilities and providers related to reporting data to EHDI program (diagnostic and early intervention data)

Pre/post evaluation of knowledge and skills

Increased collaboration between internal and external partners about sustained tracking and surveillance activities

Number of signed MOU/MOA/ new relationship, policies, events situation etc. with potential for expanding EHDI capacity in collecting diagnosis and early intervention data.

Increased number of providers able to report follow-up re-screening and diagnostic data.

Document the number of audiologists reporting over time and/or affiliated facility

INTERMEDIATE OUTCOMES OUTCOME MEASURES

Increased reporting by providers of all diagnoses (i.e.hearing loss and no hearing loss) in a timely manner to the EHDI program

Document the percentage of audiologists reporting all diagnostic results

Improve consistency and completeness of Early Intervention data reported to the EHDI program

Documentation of enrollment day Defined by CDC as Individual Family Service Plan (IFSP) date

Increased knowledge among program staff and stakeholders of current strengths and weaknesses of the EHDI Information System

Description of actions taken during the reporting period to improve program activities and increase program effectiveness based on evaluation findings, and data analysis

Improved program planning, policy development, and decision making to support tracking and surveillance activities

New policy, event, situation as a result of data utilization and extensive collaboration with stakeholders, which support the accomplishment of the EHDI-IS goals

LONG -TERM OUTCOMES OUTCOME MEASURES

Improved documentation of follow-up diagnostic testing for infants who did not pass the newborn hearing screening

Diagnostic Services

LFU/LTD for Diagnosis

Baseline: Current percent LFU/LTD for diagnosis reported by applicant (2015 data) Target: Decrease by 30% from the baseline

Formula 1

Percentage LFU/LTD (Diagnosis)

Numerator: #Unable to Contact + #Unresponsive + #Unknown (for diagnosis)

Denominator: Total that did not pass final/most recent hearing screen

Receiving Diagnostic Assessment

Baseline: Current percent diagnosed reported by applicant (2015 data) Target: Increase by 30% from the baseline

Formula 2

Percentage Diagnosed Overall

Numerator: Total diagnosed (no hearing loss + hearing loss)

Denominator: Total that did not pass final/most recent hearing screen

Formula 3

Percentage Diagnosed before three (3) months.

Numerator: Total diagnosed before

(3) months of age (no hearing loss before 3 months of age + hearing loss before 3 months of age)

Denominator: Total that did not pass final/most recent hearing screen

Improved documentation of intervention enrollment status for those infants with identified hearing loss

Early Intervention Services

LFU/LTD for Early Intervention

Baseline: Current percent LFU/LTD for intervention reported by applicant (2015 data) Target: Decrease by 20% from the baseline

Formula 1

Percentage LFU/LTD (Early Intervention)

Numerator: #Unable to Contact + #Unresponsive + #Unknown (for early intervention)

Denominator: Total diagnosed with permanent hearing loss

Receiving Early Intervention

Baseline: Current percent enrolled in Part C and non-Part C early intervention reported by applicant (2015 data) Target: Increase by 20% from the baseline.

Formula 2

Percentage enrolled in Early Intervention Overall

Numerator: Total enrolled in early intervention (Part C & non-Part C)

Denominator: Total diagnosed with permanent hearing loss

Formula 3

Percentage enrolled in Early Intervention before 6 (six) month of age

Numerator: Total enrolled in early intervention (before 6 months, part C & non-part C)

Denominator: Total diagnosed with permanent hearing loss

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the awardee will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this FOA. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant) Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these FOA funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see http://www.cdc.gov/grants/additionalrequirements/index.html#ui-id-49

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Awardees will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, within the first 6 months of award, as described in the Reporting Section of this FOA.

Applicants must provide an overall jurisdiction specific evaluation and performance measurement plan that is consistent with the CDC’s evaluation and performance measurement strategy section of the CDC Project Description of this FOA. Data collected must be used for ongoing monitoring of the award to evaluate its effectiveness and for continuous program improvement. The plan must

Describe how key project staff and partners will be engaged in the evaluation and performance measurement planning processes;

Describe potential evaluation questions;

Describe potentially available evaluation data sources and the feasibility of accessing them; and Describe how evaluation findings will be used for continuous program and quality improvement.

Throughout the three-year project period, CDC will work individually and collectively with each of the funded jurisdictions for both core and expanded activities to evaluate its own EHDI-IS by using the following potential evaluation questions to assess EHDI –IS system attributes:

1. Data Quality:

To what extent does the EHDI-IS contain accurate, complete, unique and timely diagnostic data?

To what extent does the EHDI-IS contain accurate, complete, unique and timely early intervention data?

2. Acceptability:

To what extent do audiologists in the state know about the jurisdictional EHDI program and use the http://www.cdc.gov/grants/additionalrequirements/index.html#ui-id-49

EHDI data reporting module system?

What barriers prevent audiologist from reporting diagnostic data?

Is the data reporting system or paper form user-friendly for audiologists to report diagnostic results?

How could the EHDI program increase the awareness among the audiology community about the importance of documenting and communicating the results?

3. Usefulness & Simplicity:

Did the collected EHDI data lead to strategic actions that benefitted the program or stakeholders?

How easy of an operation is the EHDI-IS for managing data and generating reports?

While not necessary, if the applicant chooses to include a new logic model, it must align with the logic model provided in this FOA.

c. Organizational Capacity of Awardees to Implement the Approach Applicants must demonstrate that they have the capacity to meet the project requirements and successfully complete the activities defined in this CDC funding announcement. To help ensure successful completion of this project applicants for the Core* and Expanded* activities must have the following capacity. Award funds can be used to pay for part of these key roles, up to the specified limit for each Full-time Equivalent (FTE) position:

Leadership Capacity (Up to 0.30 FTE):

Project Director (PD) (Up to 0.05 FTE): A PD is the primary individual(s) responsible for the scientific, technical or programmatic aspects of the CDC cooperative agreement. The PI/PD serves a key role in providing administrative oversight, budget management, and meeting project goals. This individual should have project management and supervisory experience.

Project Manager (Up to 0.25 FTE): A project manager is the person responsible for leading the project and the day-to-day management of the project. He/she is responsible for the planning, implementing, and completing project tasks. Key tasks include management of the CDC cooperative agreement, developing and monitoring the project’s work plan, preparation of reports, development and maintaining of partnerships with stakeholders, communication with partners and CDC, and overseeing evaluation activities. This individual should have training and/or experience in project management.

Surveillance Capacity (Up to 0.50 FTE for Core Only / 0.25 FTE for Core + Expanded)

Performs a variety of tasks to assure the quality and integrity of EHDI follow-up data and support evaluation activities. His/her primary responsibility is to improve the documentation of diagnostic and early intervention data. This includes monitoring the EHDI follow-up data collection processes and providing interim and summary reports to improve tracking and surveillance activities. In addition, this individual may be responsible for the management of the data system, as well as providing technical assistance or training, designing and compiling summary statistics report on diagnostic and early intervention data. This individual should have knowledge of research methodology, experience in data collection, management, analysis and interpersonal skills.

Evaluation and Performance Monitoring Capacity (Up to 0.15 FTE)

Responsible for conducting evaluation activities, including the development, coordination, and implementation of an EHDI-IS evaluation plan in close collaboration with stakeholders, and using evaluation findings to support program improvements. This individual should be familiar with evaluation methods and have training and/or prior experience conducting an evaluation. He/she should also be able to present evaluation findings and conclusions to a variety of audiences.

Applicants for the Expanded activities must also have the following additional capacity.

Data Analysis and Quality Assurance Capacity (e.g. Epidemiologist) (Up to 0.75 FTE)

Collects and analyzes data, and disseminates findings with the team and relevant stakeholders. Key tasks include: (1) identifying data elements affecting data quality and ways to improve data collection;

(2) using epidemiological and statistical methods to identify sections of the population at greatest risk for loss to follow-up (LFU) or loss to documentation (LTD); (3) determining key epidemiological indicators of the EHDI program including: average age of hearing loss identification, average age of enrollment into EI; (4) determining the strengths and weaknesses of the EHDI-IS to establish priorities for updates and improvements; (5) supporting evaluation of the effectiveness of the EHDI-IS; and (6) disseminating relevant, detailed EHDI data to stakeholders to support and improve diagnostic and early intervention data collection and use. The person serving in this role should have knowledge of epidemiological methods, statistical skills to evaluate and interpret data, and experience in preparing and presenting technical and non-technical information to diverse audiences.

Health Informatics (Up to 0.25 FTE), if needed: Assist in ensuring standardized data definitions are applied, the preparing and validation of data files submitted to CDC and the identifying and resolving of any data errors. The person serving in this role should have experience working on large public health datasets.

Notes

A resume/CV that reflects the necessary training and experience for each individual that will serve in these defined roles is required.

1.

Each of these positions (up to four positions under Core and six positions under Core and Optional Expanded) is designated as a key role under this FOA and prompt notification about changes to individuals serving in any of these key roles is required to be provided to the Office of Grant Services (OGS) at the CDC Office of Financial Resources (OFR).

2.

d. Work Plan Applicants must submit a work plan that covers the first year of the three-year project period, and a summary of activities for Years 2-3. Proposed strategies must be in alignment with the FOA logic model. Required elements in a work plan include strategies and their associated performance measures (with data sources, targets, and timeframes), as well as major activities and the person responsible for each activity. Applicants should insert “N/A” for any strategies they do not intend to implement in a given year. A work plan template is available at www.cdc.gov/ncbddd/hearingloss/partners.html. Applicants are not required to use this work plan template, but any plan submitted must include all of the elements in the template.

Project Period Outcome:

[from logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies and Activities Description

Process Measure

[from Evaluation and Performance Measurement section]

Program staff responsible

Timeframe

1.

2.

3.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee reporting (including work plans, performance, and financial reporting). Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking awardee progress in achieving the desired outcomes.

Ensuring the adequacy of awardee systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that awardees are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with awardees on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk grantees.

f. CDC Program Support to Awardees (THIS SECTION APPLIES ONLY TO COOPERATIVE

AGREEMENTS)

Core Activities

CDC staff involved with this cooperative agreement will provide substantial involvement beyond site visits and regular performance and financial monitoring during the project period. Substantial involvement means that awardees can expect federal programmatic partnership in carrying out the effort under the award. The CDC program will work in partnership with awardees to ensure the success of the cooperative agreement by:

Supporting awardees in implementing cooperative agreement requirements and advancing program activities to meet outcomes.

Providing technical assistance to revise annual work plans and budgets.

Providing consultation and guidance on enhancing and expanding existing EHDI surveillance activities, including the collection and analysis of data.

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