Comment

WA State Department of Health UDS Comments

As the Dept. of Health continues to develop our child developmental health registry, we will provide additional feedback on which standards we feel are best for universal developmental screening or if there are standards that would work well but need refinement (addition of data fields for example).   

WA State Department of Health Newborn Screening Comments

Washington State Department of Health appreciates having the standards listed on the “Reporting Newborn Screening and Birth Defects to Public Health Agencies” page and does not have any recommended changes at this time.

WA State Department of Health NBS and CDH Comments

Washington State Department of Health recommends having a separate page for public health newborn screening test ordering and reporting with reference to the Newborn Dried Blood Spot (NDBS) component of HL7 v 2.5.1 implementation Guide: Laboratory Orders from EHR (LOI) Release 3 and Lab Results Interface (LRI) Release 3. The newest version of these standards have incorporated a component for the electronic ordering and reporting for use in newborn screening programs, these versions are not currently listed on the ONC ISA. It is important to distinguish these efforts from those associated with Child Developmental Health as newborn screening is a laboratory test and public health program. We would recommend including the implementation guides for Critical Congenital Heart Defects (HL7 v 2.6 Implementation Guide: Critical Congenital Heart Defects (CCHD) pulse oximetry screening results, release 1) and Early Hearing Detection and Intervention (HL7 v 2.6 Implementation Guide: Early Hearing Detection and Intervention (EHDI) results Release 1) into a newborn screening page as many states programs include the point of care tests within their newborn screening programs. The Implementation guide for NANI could also be included with newborn screening as it serves as birth notification to newborn screening programs and is included in comprehensive newborn screening surveillance.

 

Washington State Department of Health recommends having a separate page for public health newborn screening (test orders and return of results) from birth defects registry (BDR) reporting and universal developmental screening (UDS). While new born screening, BDR, and UDS are related, they all serve a different function and may have different standards that make the most sense to use. As we continue to develop our child developmental health registries we will provide additional feedback on which standards we feel are best for BDR and UDS or if there are standards that would work well but need refinement (addition of data fields for example).

Update Test Tool

Publicly available message validation tooling for CCHD and EHDI are available through the NIST v2 Tool Portal as part of their General Validation Tool (https://hl7v2.gvt.nist.gov/gvt/#/home) via Tool Scopes of CCHD National IG and EHDI National IG respectively

Update Adoption Level

The NANI standard is in use at 200+ facilities and across multiple states. We feel that an Adoption Level of Medium (3 filled circles) may be appropriate

Update Maturity Level

All of the NANI, CCHD or EHDI standards are in production use somewhere in the United States. We suggest that the Implementation Maturity for these standards be upgraded from “Pilot” to “Production”

Normative status for CCHD and EHDI

The CCHD and EHDI standards were published in 2020 as normative so the Standards Process Maturity should be Final rather than Balloted Draft

Add DAR IG

We suggest adding the v2.6 Diagnostic Audiology Reporting implementation guide to the Newborn Screening section. This IG is currently under development at HL7 and should be published as an STU standard later in 2021.

Add LOI and LRI IGs to the newborn section

We suggest adding the v2.5.1 LOI and LRI here and note these IGs contain profiles for newborn dried blood spot testing. Our research as part of the Innovations in Newborn Screening Interoperability project indicates that ~25% of jurisdictions are doing some sort of electronic order and result exchanges. We believe a low to medium adoption rate is appropriate.