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Req-1146: Newborn Screening - Testing
Release Package: 2013 Format


Release Package:

2013 Format

Requirement ID:

Req-1146

Title:

Newborn Screening - Testing

Description:

The goal of newborn screening is to identify a wide range of conditions that can potentially benefit from early detection during the presymptomatic or early symptomatic period. Historically, newborn screening has been based on dried blood spot analysis by state public health departments. More recently, point-of-service testing in the nursery (e.g., newborn hearing screening) has been included. Another point-of-service test that will likely be added to newborn screening is pulse oximetry to detect critical cyanotic congenital heart disease. Newborn screening is expanding at a rapid rate. Although the US Secretary of Health and Human Services makes recommendations about what should be included as part of newborn screening, individual states are responsible for developing their own panel, including the threshold for a positive test. Some states require retesting of all newborns. States have varying methods of short and long-term follow-up for those that have tested positive. Some parents may choose to have supplemental newborn screening through private laboratories. This is outside of the scope of these requirements.
ONC and HRSA are actively developing use cases and other health IT resources around newborn screening. A use case is available at:http://www.hhs.gov/healthit/usecases/documents/NBSDetailedUseCase.pdf. The U.S. National Library of Medicine (NLM) has published the Newborn Screening Coding and Terminology to promote and facilitate the use of electronic health data standards for the conditions recommended for screening by the HHS Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). This is available at: http://newbornscreeningcodes.nlm.nih.gov/.
The National Newborn Screening and Genetics Resource Center (http://genes-r-us.uthscsa.edu/) provides continuously updated information on the conditions screened for in each state. In addition, links are available to each state program. The Resource Center also provides educational material for clinicians and family members.
Well-described clinical algorithms have been developed to guide general pediatricians and subspecialists in the process of newborn screening. These are available at:http://pediatrics.aappublications.org/content/121/1/192.abstract. The requirements were designed to support these algorithms. In addition, these requirements support the transition from diagnosis through screening to chronic condition management and long-term follow-up as described in Kemper AR, Boyle CA, Aceves J, et al. Long-term follow-up after diagnosis resulting from newborn screening: statement of the US Secretary of Health and Human Services' Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children. Genet Med. 2008:10:259-261.

Related Requirements:

Relationship Release Package Requirement ID Requirement Title Requirement Type SHALL / SHOULD / MAY Compare Requirements
Req-1146 Is Child Of 2013 Format Req-281 Documentation of Care, Measurements and Results Header Not Applicable Compare
Req-1146 Is Parent Of 2013 Format Req-800 Newborn dried blood spot collection time and state Normative Statements SHALL Compare
Req-1146 Is Parent Of 2013 Format Req-801 Record time when mandated point-of-service testing occurred Normative Statements SHALL Compare
Req-1146 Is Parent Of 2013 Format Req-802 Record refusal of newborn dried blood spot testing Normative Statements SHALL Compare
Req-1146 Is Parent Of 2013 Format Req-803 Record refusal of point-of-service testing Normative Statements SHALL Compare
Req-1146 Is Parent Of 2013 Format Req-1103 Store codified newborn screening results Normative Statements SHALL Compare

Topic Area(s):

Provenance:

SME

Achievability:

Requirement Type:

Header

Shall/Should/May:

Critical/Core:

No

Status:

Released

Links:

ONC/HRSA Use Cases: ONC and HRSA are actively developing use cases and other health IT resources around newborn screening.
http://www.hhs.gov/healthit/usecases/documents/NBSDetailedUseCase.pdf

NLM Newborn Screening Coding and Terminology: The U.S. National Library of Medicine (NLM) has published the Newborn Screening Coding and Terminology to promote and facilitate the use of electronic health data standards for the conditions recommended for screening by the HHS Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC).
http://newbornscreeningcodes.nlm.nih.gov/

The National Newborn Screening and Genetics Resource Center: The National Newborn Screening and Genetics Resource Center provides continuously updated information on the conditions screened for in each state. In addition, links are available to each state program. The Resource Center also provides educational material for clinicians and family members.
http://genes-r-us.uthscsa.edu/

Newborn screening clinical algorithms: Well-described clinical algorithms have been developed to guide general pediatricians and subspecialists in the process of newborn screening.
http://pediatrics.aappublications.org/cgi/content/abstract/121/1/192

See Also:

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Comments:

Not Provided

Additional Information:

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Last Updated 04/13/2016
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