Early Hearing Detection and Intervention Information System (EHDI-IS) Functional Standards

EHDI-IS Functional Standards Overview

This document summarizes recommendations made by the 2015 Early Hearing Detection and Intervention Information System (EHDI-IS) Functional Standard Working Group (FSWG), on the technical function 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. These Standards were initially drafted by CDC EHDI program staff and then discussed and reviewed with the FSWG through bi-weekly conference calls. Intended users of these standards include state and territorial EHDI program managers, EHDI-IS developers/vendors, and system evaluators.

EHDI-IS Functional Standards

This document is divided into 3 main sections:

  1. General Considerations delineates key background realities under which the Functional Standards should be interpreted and implemented
  2. Programmatic Goals lays out the foundational goals that these Functional Standards are intended to address.
  3. Functional Standards by Programmatic Goal describes specific standards that address each of the Programmatic Goals.

Appendix-A Cdc-excel[XLS – 22 KB]: Data item list and data definitions of categorical data items.

Appendix-B Cdc-pdf[PDF – 195 KB]: Six dimensions of EHDI Data Quality Assessment

General Considerations

  • These functional standards are intended to identify the operational, programmatic, and technical criteria that all jurisdictional EHDI programs should implement during the process of developing, using, and evaluating an EHDI Information System (EHDI-IS).
  • The Functional Standards are NOT intended to provide specifications on how those functions are supposed to be implemented.
  • In some cases, current state law(s) or policies may preempt full implementation of these standards. In these instances, an unmet standard may serve as a suggestion for possible future revisions.

Programmatic Goals

  1. Document unduplicated, individually identifiable data on the delivery of newborn hearing screening services for all infants born in the jurisdiction.
  2. Support tracking and documentation of the delivery of follow-up services for every infant/child who did not receive, complete or pass the newborn hearing screening.
  3. Document all cases of hearing loss, including congenital, late-onset, progressive, and acquired cases for infants/children <3 years old.
  4. Document the enrollment status, delivery and outcome of early intervention services for infants and children <3 years old with hearing loss.
  5. Maintain data quality (accurate, complete, timely data) of individual newborn hearing screening, follow-up screening and diagnosis, early intervention and demographic information in the EHDI-IS.
  6. Preserve the integrity, security, availability and privacy of all personally-identifiable health and demographic data in the EHDI-IS.
  7. Enable evaluation and data analysis activities.
  8. Support dissemination of EHDI information to authorized stakeholders.
SHALL, SHOULD, MAY

SHALL: Indicates a mandatory requirement to be followed/ implemented

SHOULD: Indicates an optional recommended action

MAY: Indicates an optional action

Goal Statement 1: Document unduplicated individually identifiable data on the delivery of newborn hearing screening services for all infants born in the jurisdiction.

1.1 The EHDI-IS SHALL provide a unique patient record for each newborn child born in the jurisdiction.

1.2 The EHDI-IS SHALL receive and document information about patient’s birth encounter and newborn admission information in a timely manner in accordance with scope of practice, organizational policy and jurisdictional law.

1.3 The EHDI-IS SHALL receive and document patient’s maternal demographic information, in accordance with scope of practice, organizational policy and jurisdictional law.

1.4 The EHDI-IS SHALL receive and document all individual newborn hearing screening procedures and results, in a timely manner in accordance with scope of practice, organizational policy and jurisdictional law.

1.5 The EHDI-IS SHOULD receive and document information about risk factors of infant hearing loss at the time of newborn hearing screening.

1.6 The EHDI-IS SHALL review incoming and existing patient records and document the most recent newborn hearing screening status and outcome (pass, refer, not screened) of the patient.

1.7 The EHDI-IS SHALL receive and document information on the reason why an infant hearing screening is not performed or completed.

1.8 The EHDI-IS SHALL provide the ability to capture and document information about an infant’s NICU stay and transfer status.

1.9 The EHDI-IS MAY receive submissions of newborn hearing screening information in accordance with interoperability standards endorsed by CDC for message content, format and transport.

SHALL, SHOULD, MAY

SHALL: Indicates a mandatory requirement to be followed/ implemented

SHOULD: Indicates an optional recommended action

MAY: Indicates an optional action

Goal Statement 2: Support tracking and documentation of the delivery of follow-up services for every infant/child who did not receive, complete or pass newborn hearing screening.

2.1 The EHDI-IS SHOULD provide a unique patient record for each infant/child born out of the jurisdiction but currently reside within the jurisdiction and is in need of hearing screening or diagnostic follow-up services.

2.2 The EHDI-IS SHALL provide the ability to generate and present a list of infants who did not pass newborn hearing screening (including initial screening and any follow-up rescreening) and are in need of follow-up rescreening and/or diagnostic evaluation services.

2.3 The EHDI-IS SHALL provide the ability to generate and present a list of infants who did not receive or complete newborn hearing screening and are in need of recommended screening and/or diagnostic evaluation services.

2.4 The EHDI-IS MAY provide the ability to make referrals for recommended follow-up services

2.5 The EHDI-IS SHALL document referrals made.

2.6 The EHDI-IS SHALL receive and document information on rescreening procedures and results in a timely manner in accordance with scope of practice, organizational policy and jurisdictional law.

2.7 The EHDI-IS SHALL receive and document information on procedures and results of ALL follow-up audiological diagnostic evaluation services in a timely manner in accordance with scope of practice, organizational policy and jurisdictional law.

2.8 The EHDI-IS SHALL receive and document information whenever there is a change in the patient’s hearing status and/or an update on previously inconclusive/incomplete diagnostic result.

2.9 The EHDI-IS SHOULD receive and document information about referrals and/or recommendations made following an audiological diagnostic evaluation.

2.10 The EHDI-IS SHALL receive and document information on the reason why an infant did not receive recommended follow-up services.

2.11 The EHDI-IS SHOULD provide the ability to notify parents and healthcare providers of infants who are in need of follow-up services.

2.12 The EHDI-IS MAY provide the ability to generate, present, and transmit a standard-based hearing plan of care document to guide follow-up practices in accordance with scope of practice, organizational policy and jurisdictional law.

SHALL, SHOULD, MAY

SHALL: Indicates a mandatory requirement to be followed/ implemented

SHOULD: Indicates an optional recommended action

MAY: Indicates an optional action

Goal Statement 3: Document ALL cases of permanent hearing loss, including congenital, late-onset, progressive, and acquired cases for infants/children < 3 years old.

3.1 The EHDI-IS SHALL receive and document information on all confirmed hearing loss cases identified through the newborn hearing screening follow-up process and reported from audiological providers.

3.2 The EHDI-IS SHALL provide the ability to receive and document information on additional infants/children with hearing loss that are not identified through the newborn hearing screening follow-up process, e.g. reported from primary care providers, or through data exchange with the early intervention (EI) systems, and other public health information systems and/or registries, in accordance with scope of practice, organizational policy and jurisdictional law.

3.3 The EHDI-IS SHALL use the American Speech-Language Hearing Association (ASHA) standards for classifying degree of hearing loss.

3.4 For every documented permanent hearing loss case in the EHDI-IS, the EHDI-IS SHALL provide the ability to generate and present the patient’s complete screening and diagnostic service history including date, location, type and results of tests performed and/or diagnosis made.

3.5 The EHDI-IS SHOULD receive and document information on hearing loss risk factors.

3.6 The EHDI-IS SHOULD provide the ability to regularly evaluate incoming and existing hearing screening and diagnostic information to continually refine, modify and efficiently identify late onset, progressive and acquired hearing loss.

3.7 The EHDI-IS SHALL provide the ability to generate and present separate lists of infants/children with presumed congenital (referred on newborn hearing screening) and late-onset/progressive/acquired hearing loss.

SHALL, SHOULD, MAY

SHALL: Indicates a mandatory requirement to be followed/ implemented

SHOULD: Indicates an optional recommended action

MAY: Indicates an optional action

Goal Statement 4: Document the enrollment status, delivery and outcome of EI services for infants and children with hearing loss < 3 years old.

4.1 The EHDI-IS SHALL provide the ability to identify infants/children who need EI services

4.2 The EHDI-IS SHALL receive and document information about referrals to Part C services

4.3 The EHDI-IS SHALL receive and document information about eligibility to Part C services

4.4 The EHDI-IS SHALL receive and document information on Part C EI (i.e. date when the Individual Family Service Plan or IFSP is signed).

4.5 The EHDI-IS SHALL receive and document information on other non-Part C early intervention services enrollment, in accordance with scope of practice, organizational policy and jurisdictional law.

4.6 The EHDI-IS SHOULD provide the ability to receive and document recommended audiologic intervention method upon a hearing loss diagnosis from providers.

4.7 The EHDI-IS SHOULD provide the ability to receive and document data on early intervention outcomes.

4.8 The EHDI-IS SHOULD provide the ability to compare and match infants in the system with those in the EI system to identify missed cases.

4.9 The EHDI-IS SHOULD provide the ability to notify parents, healthcare and EI providers of infants’ need for EI services.

SHALL, SHOULD, MAY

SHALL: Indicates a mandatory requirement to be followed/ implemented

SHOULD: Indicates an optional recommended action

MAY: Indicates an optional action

Goal Statement 5: Maintain data quality (accurate, complete, timely data) of individual newborn hearing screening, follow-up screening and diagnosis, early intervention and demographic information in the EHDI-IS.

5.1 The EHDI-IS SHALL provide the ability to regularly evaluate incoming and existing patient records to identify, prevent, and resolve duplicate and fragmented records.

5.2 The EHDI-IS SHALL store all EHDI-IS Minimum Data Elements (see Appendix A for all data elements)

5.3 The EHDI-IS SHALL provide the ability to obtain other Core Data Elements.

5.4 The EHDI-IS SHOULD provide the ability to obtain Extended Data Elements.

5.5 The system SHALL provide the ability to analyze information with respect to data quality according to scope of practice, organizational policy, and/or jurisdictional law (see appendix B for guidance on essential data quality attributes).

5.6 The EHDI-IS SHALL retain all patient data in the system until the patient reaches at least 3 years old, except where prohibited by law, regulation, or policy.

5.7 The EHDI-IS SHOULD allow re-activating a case when new information is obtained that illuminates the disposition of a case.

5.8 The EHDI-IS SHOULD provide the ability for staff to record notes and phone interactions with the public (parents, providers, hospitals) within each child’s file.

5.9 The EHDI-IS SHOULD provide the users with easy access to metadata, system documentation and user guide.

SHALL, SHOULD, MAY

SHALL: Indicates a mandatory requirement to be followed/ implemented

SHOULD: Indicates an optional recommended action

MAY: Indicates an optional action

Goal Statement 6: Preserve the integrity, security, availability and privacy of all personally-identifiable health and demographic data in the EHDI-IS.

6.1 The EHDI program SHALL have written confidentiality and privacy practices and policies based on applicable law or regulation that protect all individuals whose data are contained in the EHDI-IS system.

6.2 The EHDI program SHALL have written data sharing and confidentiality/privacy agreement with any other information systems which the EHDI-IS links to and/or shares data with.

6.3 The EHDI-IS SHALL have user access controls and logging, including distinct credentials for each user, least-privilege access, and routine maintenance of access privileges.

6.4 THE EHDI-IS SHALL be operated or hosted on secure hardware and with software in accordance with industry standards for protected health information, including standards for security/encryption, uptime and disaster recovery.

SHALL, SHOULD, MAY

SHALL: Indicates a mandatory requirement to be followed/ implemented

SHOULD: Indicates an optional recommended action

MAY: Indicates an optional action

Goal Statement 7: Enable evaluation and data analysis activities.

7.1 The EHDI-IS SHALL provide the ability for authorized users to extract and use data to assess program progress towards achieving national/jurisdictional benchmarks.

7.2 The EHDI-IS SHOULD provide the ability to generate performance measurement reports, as defined by the jurisdictional system evaluation plan.

7.3 The EHDI-IS SHOULD provide the ability for authorized users to export data to other data management and analytical software tools such as MS Excel, SAS, SPSS, etc.

SHALL, SHOULD, MAY

SHALL: Indicates a mandatory requirement to be followed/ implemented

SHOULD: Indicates an optional recommended action

MAY: Indicates an optional action

Goal Statement 8: Support dissemination of EHDI information to authorized stakeholders.

8.1 The EHDI-IS SHALL provide the ability to generate, present and transmit standard and/or custom-defined reports (e.g., CDC Hearing Screening and Follow-up Survey (HSFS) survey, loss to follow up, or other important indicators by geographic, demographic, provider, or provider groups, hospital performance report) for authorized users without assistance from system vendor or IT personnel.

8.2 The EHID-IS SHOULD provide the ability for authorized healthcare providers to electronically access newborn hearing screening and follow-up service information of their patients.